[Federal Register Volume 72, Number 161 (Tuesday, August 21, 2007)]
[Rules and Regulations]
[Pages 46716-46843]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-15565]



[[Page 46715]]

-----------------------------------------------------------------------

Part II





Department of Commerce





-----------------------------------------------------------------------



Patent and Trademark Office



-----------------------------------------------------------------------



37 CFR Part 1



 Changes To Practice for Continued Examination Filings, Patent 
Applications Containing Patentably Indistinct Claims, and Examination 
of Claims in Patent Applications; Final Rule

  Federal Register / Vol. 72, No. 161 / Tuesday, August 21, 2007 / 
Rules and Regulations  

[[Page 46716]]


-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket Nos.: PTO-P-2005-0022; PTO-P-2005-0023]
RINs 0651-AB93; 0651-AB94


Changes To Practice for Continued Examination Filings, Patent 
Applications Containing Patentably Indistinct Claims, and Examination 
of Claims in Patent Applications

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The United States Patent and Trademark Office (Office) is 
revising the rules of practice in patent cases relating to continuing 
applications and requests for continued examination practices, and for 
the examination of claims in patent applications. The Office is 
revising the rules of practice to require that any third or subsequent 
continuing application that is a continuation application or a 
continuation-in-part application, and any second or subsequent request 
for continued examination in an application family, be filed to obtain 
consideration of an amendment, argument, or evidence, and be supported 
by a showing as to why the amendment, argument, or evidence sought to 
be entered could not have been previously submitted. The Office is also 
revising the rules of practice to provide that an applicant must 
provide an examination support document that covers all of the claims 
in an application if the application contains more than five 
independent claims or more than twenty-five total claims. The Office is 
also revising the rules of practice with respect to multiple 
applications that have the same claimed filing or priority date, 
substantial overlapping disclosure, a common inventor, and common 
ownership. These changes will allow the Office to conduct a better and 
more thorough and reliable examination of patent applications.

DATES: Effective Date: November 1, 2007. For applicability and 
compliance dates see SUPPLEMENTARY INFORMATION.

FOR FURTHER INFORMATION CONTACT: The Office of Patent Legal 
Administration, by telephone at (571) 272-7704, by mail addressed to: 
Mail Stop Comments--Patents, Commissioner for Patents, P.O. Box 1450, 
Alexandria, VA 22313-1450, or by facsimile to (571) 273-0100, marked to 
the attention of the Office of Patent Legal Administration.

SUPPLEMENTARY INFORMATION: The Office is revising the rules of practice 
in patent cases relating to continued examination filings (continuing 
applications and requests for continued examination), multiple 
applications containing patentably indistinct claims, and the 
examination of claims in applications.
    The Office is revising the rules of practice for continuation 
applications, continuation-in-part applications and requests for 
continued examination. Under these revisions, an applicant may file two 
continuation applications (or continuation-in-part applications), plus 
a request for continued examination in the application family, without 
any justification. An application family includes the initial 
application and its continuation or continuation-in-part applications. 
Applicant may file any additional continuation application, 
continuation-in-part application, or request for continued examination 
with a justification. Specifically, the Office is revising the rules of 
practice to require a justification for any third or subsequent 
continuing application that is a continuation application or a 
continuation-in-part application, and any second or subsequent request 
for continued examination in an application family. The third or 
subsequent continuing application or request for continued examination 
must be filed with a petition showing why the amendment, argument, or 
evidence sought to be entered could not have been previously submitted.
    The Office is also revising the rules of practice for divisional 
applications. Under these revisions, an applicant is permitted to file 
a divisional application of an application for the claims to a non-
elected invention that has not been examined if the application was 
subject to a requirement for restriction. The divisional application 
need not be filed during the pendency of the application subject to a 
requirement for restriction, as long as the copendency requirement of 
35 U.S.C. 120 is met. Thus, applicant may file the divisional 
application during the pendency of the application that was subject to 
a requirement for restriction or the pendency of any continuing 
application of such an application. Applicant may also file two 
continuation applications of the divisional application plus a request 
for continued examination in the divisional application family, without 
any justification. A divisional application family includes the 
divisional application and its continuation applications. In addition, 
applicant may file any additional continuation application or request 
for continued examination in the divisional application family with a 
petition and adequate justification.
    The Office is also revising the rules of practice for the 
examination of claims in an application to provide that if the number 
of independent claims is greater than five or the number of total 
claims is greater than twenty-five, the Office will require the 
applicant to help focus examination by providing additional information 
to the Office in an examination support document covering all of the 
claims (whether in independent or dependent form) in the application.
    The Office is also revising the rules of practice with respect to 
multiple applications that have patentably indistinct claims and a 
common assignee by either requiring that all patentably indistinct 
claims in such applications be submitted in a single application or 
effectively treating the multiple applications as a single application.
    These changes will mean more effective and efficient examination 
for the typical applicant without any additional work on the part of 
most applicants. However, in the applications that place an extensive 
burden on the Office, the applicant will be required to help focus 
examination by providing additional information to the Office.
    Applicability Dates: The changes to 37 CFR 1.75, 1.142(c), and 
1.265 are applicable to any nonprovisional application filed under 35 
U.S.C. 111(a) on or after November 1, 2007, and to any nonprovisional 
application entering the national stage after compliance with 35 U.S.C. 
371 on or after November 1, 2007. The changes to 37 CFR 1.75, 1.142(c), 
and 1.265 are also applicable to any nonprovisional application filed 
before November 1, 2007, in which a first Office action on the merits 
was not mailed before November 1, 2007.
    The changes to 37 CFR 1.117 are applicable to any nonprovisional 
application filed before, on, or after November 1, 2007, with respect 
to any fee under 37 CFR 1.16(h), (i), or (j) or 1.492(d), (e), or (f) 
paid on or after December 8, 2004.
    The changes to 37 CFR 1.78(a), 1.78(d)(1), 1.495 and 1.704(c)(11) 
are applicable only to any application, including any continuing 
application, filed under 35 U.S.C. 111(a) on or after November 1, 2007, 
or any application entering the national stage after compliance with 35 
U.S.C. 371 on or after November 1, 2007. Except as otherwise indicated 
in this final rule, any application filed under 35 U.S.C. 111(a) on or 
after November 1, 2007, or any application entering the national stage 
after compliance with 35 U.S.C.

[[Page 46717]]

371 on or after November 1, 2007, seeking to claim the benefit under 35 
U.S.C. 120, 121, or 365(c) and 37 CFR 1.78 of a prior-filed 
nonprovisional application or international application must either: 
(1) Meet the requirements specified in one of 37 CFR 1.78(d)(1)(i) 
through (d)(1)(v); or (2) include a grantable petition under 37 CFR 
1.78(d)(1)(vi).
    With respect to applications that claim the benefit under 35 U.S.C. 
120, 121, or 365(c) only of nonprovisional applications or 
international applications filed before August 21, 2007: an application 
is not required to meet the requirements set forth in 37 CFR 1.78(d)(1) 
if: (1) The application claims the benefit under 35 U.S.C. 120, 121, or 
365(c) only of nonprovisional applications filed before August 21, 2007 
or applications entering the national stage after compliance with 35 
U.S.C. 371 before August 21, 2007; and (2) there is no other 
application filed on or after August 21, 2007 that also claims the 
benefit under 35 U.S.C. 120, 121, or 365(c) of such prior-filed 
nonprovisional applications or international applications.
    The changes to 37 CFR 1.114 are applicable to any application in 
which a request for continued examination is filed on or after November 
1, 2007. Specifically, a petition under 37 CFR 1.114(g) must accompany 
any request for continued examination filed on or after November 1, 
2007, in an application in which a request for continued examination 
has previously been filed, or in a continuation application or 
continuation-in-part application of an application in which a request 
for continued examination has previously been filed, or in an 
application whose benefit is claimed in a continuation application or 
continuation-in-part application in which a request for continued 
examination has previously been filed.
    The changes to 37 CFR 1.17, 1.26, 1.52, 1.53, 1.76, 1.78 (except 
1.78(a) and 1.78(d)(1)), 1.104, 1.105, 1.110, 1.136, 1.142(a), and 
1.145 are applicable to any nonprovisional application pending on or 
after November 1, 2007.
    Compliance Date: For applications filed before November 1, 2007, 
applicants must comply with the requirements in 37 CFR 1.78(f)(1) 
within the time periods specified in 37 CFR 1.78(f)(1)(ii), or by 
February 1, 2008, whichever is later, and applicants must comply with 
the requirements in 37 CFR 1.78(f)(2) within the time periods specified 
in 37 CFR 1.78(f)(2)(iii), or by February 1, 2008, whichever is later.

Table of Contents

I. Background
    A. Changes to Practice for Continued Examination Filings
    B. Changes to Practice for Examination of Claims in Patent 
Applications
    C. Changes to Practice for Patent Applications Containing 
Patentably Indistinct Claims
    D. Retention of First Action Final Practice and Changes in 
Second Action Final Practice
II. Discussion of Specific Rules
    This final rule amends the following sections in title 37 of the 
Code of Federal Regulations (CFR): Sec. Sec.  1.17, 1.26, 1.52, 
1.53, 1.75, 1.76, 1.78, 1.104, 1.105, 1.110, 1.114, 1.136, 1.142, 
1.145, 1.495, and 1.704. This final rule adds Sec. Sec.  1.117, and 
1.265 to title 37 of the CFR.
III. Response to Comments
    A. Changes to Continuing Application Practice
    B. Treatment of Third and Subsequent Continuation or 
Continuation-In-Part Applications
    C. Treatment of Second and Subsequent Requests for Continued 
Examination
    D. Petitions Related to Additional Continuation Applications, 
Continuation-In-Part Applications, and Requests for Continued 
Examination
    E. Treatment of Multiple Applications
    F. Changes to Practice for Examination of Claims
    G. Number of Independent and Total Claims Permitted Without an 
Examination Support Document
    H. Examination Support Document Requirements
    I. The Office's Authority to Promulgate the Changes in this 
Final Rule
    J. Changes to Internal Practice
    K. Suggestions Relating to Legislative Changes
    L. Effective Date of the Changes in this Final Rule
    M. Miscellaneous
IV. Rule Making Considerations
    A. Administrative Procedure Act
    B. Regulatory Flexibility Act
    C. Executive Order 13132 (Federalism)
    D. Executive Order 12866 (Regulatory Planning and Review)
    E. Executive Order 13175 (Tribal Consultation)
    F. Executive Order 13211 (Energy Effects)
    G. Executive Order 12988 (Civil Justice Reform)
    H. Executive Order 13045 (Protection of Children)
    I. Executive Order 12630 (Taking of Private Property)
    J. Congressional Review Act
    K. Unfunded Mandates Reform Act of 1995
    L. National Environmental Policy Act
    M. National Technology Transfer and Advancement Act
    N. Paperwork Reduction Act

I. Background

    In view of the need for a better focused and effective examination 
process to reduce the large and growing backlog of unexamined 
applications while maintaining or improving the quality of issued 
patents, the Office published two notices in January of 2006 proposing 
changes to the practice for continuing applications, requests for 
continued examination, multiple applications containing patentably 
indistinct claims, and the examination of claims in applications. See 
Changes to Practice for Continuing Applications, Requests for Continued 
Examination Practice, and Applications Containing Patentably Indistinct 
Claims, 71 FR 48 (Jan. 3, 2006), 1302 Off. Gaz. Pat. Office 1318 (Jan. 
24, 2006) (proposed rule) (hereinafter ``Continuing Applications 
Proposed Rule'') and Changes to Practice for the Examination of Claims 
in Patent Applications, 71 FR 61 (Jan. 3, 2006), 1302 Off. Gaz. Pat. 
Office 1329 (Jan. 24, 2006) (proposed rule) (hereinafter ``Claims 
Proposed Rule'').
    Both the Continuing Applications Proposed Rule and the Claims 
Proposed Rule requested public comments and provided a comment period 
of four months to give the public an opportunity to submit written 
comments. The Office provided this extended comment period to ensure 
that the public would have sufficient time to submit written comments 
on the proposed changes to the rules of practice and to ensure that the 
Office would receive comments from all interested persons and 
organizations. In addition to the notices and requests for written 
comments, the Office conducted public meetings including town hall 
meetings and presentations at various locations in the United States to 
discuss the proposed changes and obtain feedback from the public. The 
Office received over five hundred written comments from government 
agencies, universities, intellectual property organizations, industry, 
law firms, individual patent practitioners, and the general public. The 
Office has spent nearly one year carefully analyzing and considering 
all of the written comments that were received. The comments and the 
Office's responses to the comments are provided in Section III, 
Response to Comments. In response to the comments, the Office has made 
appropriate modifications to the proposed changes to balance the 
interests of the public, patent owners, applicants, practitioners, and 
other interested parties with the need to reduce the large and growing 
backlog of unexamined patent applications, improve the quality of 
issued patents, and make the patent examination process more effective.
    Under the proposed changes, applicants would have been permitted to 
file one of the following without any

[[Page 46718]]

justification: A continuation application, a continuation-in-part 
application, or a request for continued examination. By contrast, this 
final rule permits applicants to file two continuation applications or 
continuation-in-part applications, plus a single request for continued 
examination in an application family, without any justification. 
Applicant may file any additional continuing application or request for 
continued examination with a justification. Under the proposed changes, 
about eleven percent of the applications and requests for continued 
examination filed in fiscal year 2006 would have required a 
justification, where under the changes being adopted in this final rule 
less than three percent of the applications and requests for continued 
examination filed in fiscal year 2006 would have required a 
justification.
    The proposed changes would have permitted applicants to file a 
divisional application of an application for the claims to a non-
elected invention if the application is subject to a requirement for 
restriction and the divisional application is filed during the pendency 
of that application. However, this final rule permits applicant to file 
a divisional application of an application if the application is 
subject to a requirement for restriction and the divisional application 
meets the copendency requirement of 35 U.S.C. 120. Thus, this final 
rule allows applicants to file divisional applications in series 
whereas the proposed rule would have required applicants to file 
divisional applications in parallel. This final rule also permits 
applicant to file two continuation applications of a divisional 
application, plus a request for continued examination in the divisional 
application family, without any justification. Under the proposed 
changes, about thirteen percent of divisional applications filed in 
fiscal year 2006 would need to have been filed earlier, where the 
changes being adopted in this final rule would not have required any of 
the divisional applications filed in fiscal year 2006 to have been 
filed earlier.
    The proposed changes would have required applicant to provide an 
examination support document before the first Office action on the 
merits if applicant designated more than ten representative claims 
including all of the independent claims in the application for initial 
examination. The Office received a substantial number of comments from 
the public opposing this ``representative claims'' examination approach 
and suggesting that the Office should simply adopt a threshold to 
invoking the examination support document requirement based upon 
whether an application contains more than a given number of independent 
and total claims. The Office took those comments into consideration and 
adopted a similar approach. This final rule requires an applicant to 
submit an examination support document before the issuance of a first 
Office action on the merits of an application to assist in the 
patentability determination when the applicant presents more than five 
independent claims or more than twenty-five total claims in an 
application. This final rule also encourages applicant to submit all of 
the claims that are patentably indistinct in one single application and 
requires applicant to identify multiple applications that contain 
patentably indistinct claims (same as the proposed rule). Therefore, 
for each invention, an applicant is permitted to present up to fifteen 
independent claims and seventy-five total claims via an initial 
application and two continuation or continuation-in-part applications 
without providing either an examination support document or 
justification, as long as those applications are either prosecuted 
serially or contain patentably distinct claims. An examination support 
document must include a preexamination search statement, a listing of 
references deemed most closely related to the subject matter of each of 
the claims, an identification of all of the claim limitations that are 
disclosed in the references, a detailed explanation particularly 
pointing out how each of the independent claims is patentable over the 
cited references, and a showing of where each claim limitation finds 
support under 35 U.S.C. 112, ] 1, in the application and any prior-
filed application. The examination support document will assist the 
Office in the examination process and the determination of 
patentability of the invention by providing the most relevant prior art 
and other useful information.
    Under the proposed changes, about one percent of the applications 
filed in fiscal year 2006 would have required either the cancellation 
of one or more independent claims or an examination support document. 
Furthermore, about eighty percent of the applications filed in fiscal 
year 2006 would have required either a designation of dependent claims 
for initial examination or an examination support document. Under the 
changes being adopted in this final rule, less than eight percent of 
the applications filed in fiscal year 2006 would have required either 
the cancellation of one or more independent claims or an examination 
support document. In addition, less than twenty-five percent of the 
applications filed in fiscal year 2006 would have required either the 
cancellation of one or more dependent claims or an examination support 
document. However, by prosecuting an initial application and two 
continuation applications serially, about ninety-five percent of the 
applications filed in fiscal year 2006 would not have required either 
the cancellation of any claims or an examination support document.

A. Changes to Practice for Continued Examination Filings

    The volume of continued examination filings (including both 
continuing applications and requests for continued examination) and 
duplicative applications that contain ``conflicting'' or patentably 
indistinct claims, is having a crippling effect on the Office's ability 
to examine ``new'' (i.e., non-continuing) applications. Continued 
examination filings, other than divisional applications, as a 
percentage of overall filings, has increased from about 11.4 percent in 
fiscal year 1980, to about 18.9 percent in fiscal year 1990, to 21.9 
percent in fiscal year 2000, to 29.4 percent in fiscal year 2006. The 
cumulative effect of these continued examination filings is too often 
to divert patent examining resources from the examination of new 
applications disclosing new technology and innovations, to the 
examination of applications that are a repetition of prior applications 
that have already been examined and have either issued as patents or 
become abandoned. In addition, when the continued examination process 
fails to reach a final resolution, and when multiple applications 
containing claims to patentably indistinct inventions are filed, the 
public is left with an uncertainty as to what the set of patents 
resulting from the initial application will cover. Thus, these 
practices impose a burden on innovation both by retarding the Office's 
ability to examine new applications and by undermining the function of 
claims to notify the public as to what technology is or is not 
available for use.
    Commentators have noted that an applicant's use of the unrestricted 
continuing application and request for continued examination practices 
may preclude the Office from ever finally rejecting an application or 
even from ever finally allowing an application. See Mark A. Lemley and 
Kimberly A. Moore, Ending Abuse of Patent

[[Page 46719]]

Continuations, 84 B.U. L. Rev. 63, 64 (2004). The burden imposed by the 
repetitive filing of applications (as continuing applications) on the 
Office (as well as on the public) is not a recent predicament. See To 
Promote the Progress of Useful Arts, Report of the President's 
Commission on the Patent System, at 17-18 (1966) (recommending changes 
to prevent the repetitive filing of dependent (i.e., continuing) 
applications). Unrestricted continued examination filings and multiple 
applications containing patentably indistinct claims, however, are now 
having such an impact on the Office's ability to examine new 
applications that it is appropriate for the Office to clarify the 
applicant's duty to advance applications to final action by placing 
some conditions on the filing of multiple continuing applications, 
requests for continued examination, and other multiple applications to 
the same invention. See 35 U.S.C. 2(b) (authorizes the Office to 
establish regulations, not inconsistent with law, which shall govern 
the conduct of proceedings in the Office, and shall facilitate and 
expedite the processing of patent applications). The changes in this 
final rule will permit the Office to apply the patent examining 
resources otherwise consumed by these applications to the examination 
of new applications and thereby reduce the backlog of unexamined 
applications.
    The Office also notes that not every application as filed 
particularly points out and distinctly claims what the applicant 
regards as his or her invention. For example, this may occur where the 
applicant's attorney or agent has not adequately reviewed or revised 
the application documents received from the applicant. Applicants 
frequently file literal translations of foreign documents as 
applications, resulting in problems with compliance with U.S. patent 
law, such as the written description requirement, as well as problems 
with formatting and presentation of the claims. In these situations, 
examination of what applicants actually regard as their invention may 
not begin until after one or more continued examination filings. 
Applicants should not rely on an unlimited number of continued 
examination filings to correct deficiencies in the claims and 
disclosure that applicant or applicant's representative could have 
corrected earlier. In addition, while only a small minority of 
applications are a third or subsequent continuing application, it 
appears that some applicants and practitioners have used multiple 
continued examination filings as a strategy to delay the conclusion of 
examination. The Office, however, considers such a strategy to be a 
misuse of continued examination practice. Specifically, the Office 
considers such a strategy to be inconsistent with an applicant's and 
practitioner's duty under 37 CFR 10.18(b)(2)(i) not to submit an 
application or other filing to cause unnecessary delay or needless 
increase in the cost of prosecution before the Office. This misuse of 
continued examination practice also prejudices the public by keeping 
applications in pending status while awaiting developments in similar 
or parallel technology and then later amending their applications to 
cover these developments. The courts have permitted the addition of 
claims, when supported under 35 U.S.C. 112, ] 1, to encompass products 
or processes later discovered in the marketplace. See PIN/NIP, Inc. v. 
Platt Chemical Co., 304 F.3d 1235, 1247, 64 U.S.P.Q.2d 1344, 1352 (Fed. 
Cir. 2002). However, the practice of maintaining continuing 
applications to delay the conclusion of examination for the purpose of 
adding claims after such discoveries is inconsistent with the duty 
under 37 CFR 10.18(b)(2)(i) not to submit filings to cause unnecessary 
delay or needless increase in the cost of prosecution before the 
Office.
    The Office, in light of its backlog and anticipated continued 
increase in application filings, is making every effort to become more 
efficient. Achieving greater efficiency requires the cooperation of 
those who provide the input into the examination process, the 
applicants and their representatives.
    In the Continuing Applications Proposed Rule, the Office proposed 
to change the rules of practice to require that: (1) Any second or 
subsequent continued examination filing (continuation or continuation-
in-part application or request for continued examination) include a 
showing that the amendment, argument, or evidence could not have been 
submitted prior to the close of prosecution after a single continuation 
or continuation-in-part application or request for continued 
examination; and (2) multiple applications that have the same claimed 
filing or priority date, substantial overlapping disclosure, a common 
inventor, and a common assignee include either an explanation of how 
the claims are patentably distinct, or a terminal disclaimer and 
explanation of why patentably indistinct claims have been filed in 
multiple applications.
    In response to the comments on the proposed changes to the 
practices for continued examination filings, the Office has modified 
these provisions relative to proposed changes. Under this final rules, 
an applicant may instead file two continuation applications (or two 
continuation-in-part applications, or one continuation application and 
one continuation-in-part application), plus a request for continued 
examination in any one of the initial application or two continuation 
or continuation-in-part applications, without any justification. Any 
additional continuation application, continuation-in-part application, 
or request for continued examination, however, must be filed to obtain 
consideration of an amendment, argument, or evidence, and be supported 
by a showing as to why the amendment, argument, or evidence sought to 
be entered could not have been previously submitted. This final rule 
would also ease the burden of examining multiple applications that have 
the same claimed filing or priority date, substantial overlapping 
disclosure, a common inventor, and common assignee by requiring that 
all patentably indistinct claims in such applications be submitted in a 
single application absent good and sufficient reason.
    As discussed previously, the unrestricted continued examination 
practice and the filing of multiple applications containing patentably 
indistinct claims are impairing the Office's ability to examine new 
applications without real certainty that these practices effectively 
advance prosecution, improve patent quality, or serve the typical 
applicant or the public. These changes to the rules in title 37 of the 
CFR are intended to ensure that continued examination filings are used 
efficiently to move applications forward. The Office expects that the 
changes to the rules of practice in this final rule will: (1) Lead to 
more focused and efficient examination, improve the quality of issued 
patents, result in patents that issue faster, and give the public 
earlier notice of what the patent claims cover; and (2) address the 
growing practice of filing (by a common applicant or assignee) multiple 
applications containing patentably indistinct claims.
    35 U.S.C. 111(a) and 120, respectively, permit an applicant to file 
a nonprovisional application and to claim the benefit of a prior-filed 
nonprovisional application. Similarly, 35 U.S.C. 363 and 365(c), 
respectively, permit an applicant to file an international application 
under Patent Cooperation Treaty (PCT) Article 11 and 35 U.S.C. 363 and, 
if the international application designates the United States of 
America, to claim the benefit of a prior-filed international 
application

[[Page 46720]]

designating the United States of America or a prior-filed 
nonprovisional application. Similarly again, 35 U.S.C. 111(a) and 
365(c) permit an applicant to file a nonprovisional application (filed 
under 35 U.S.C. 111(a)) and to claim the benefit of a prior-filed 
international application designating the United States of America 
(under 35 U.S.C. 365(c)).
    35 U.S.C. 120 is generally considered the statutory basis for 
continuing application practice. See Symbol Techs., Inc. v. Lemelson 
Med., 277 F.3d 1361, 1365, 161 U.S.P.Q.2d 1515, 1518 (Fed. Cir. 2002) 
(35 U.S.C. 120 and 121 form the backbone of modern continuation and 
divisional application practice) (Symbol I). Nothing in 35 U.S.C. 120 
or its legislative history suggests that the Office must or even should 
permit an applicant to file an unlimited number of continuing 
applications without any justification.
    The practice of filing ``continuation applications'' arose early in 
Office practice mainly as a procedural device to effectively permit the 
applicant to amend an application after a rejection and receive an 
examination of the ``amended'' (or new) application. See In re Bogese, 
22 U.S.P.Q.2d 1821, 1824 (Comm'r Pats. 1991) (Bogese I). The concept of 
a continuation application per se was first recognized in Godfrey v. 
Eames, 68 U.S. (1 Wall.) 317, 325-26 (1864). See Bogese I, 22 
U.S.P.Q.2d at 1824. 35 U.S.C. 120 is a codification of the continuation 
application practice recognized in Godfrey v. Eames. See id. (citing In 
re Hogan, 559 F.2d 595, 603, 194 U.S.P.Q. 527, 535 (C.C.P.A. 1977)).
    An applicant should understand, however, that he or she does not 
have an unfettered right to file multiple continuing applications 
without making a good faith attempt to claim the applicant's invention. 
35 U.S.C. 2(b) gives the Director the inherent authority to promulgate 
regulations to ensure that applicants prosecute applications in good 
faith. Moreover, by assuming that an unlimited number of continuations 
are available, applicants have slipped into unfocused practices in 
prosecution that impede the Office's ability to conduct effective 
examination. Such practices likewise cause delays in prosecution and 
increase the cost of examination, both of which are contrary to an 
applicant's duties under the rules of conduct before the Office set 
forth in 37 CFR Part 10.
    The changes in this final rule do not set a per se limit on the 
number of continuing applications. Nor are the changes intended to 
address extreme cases of prosecution laches or to codify In re Bogese, 
303 F.3d 1362, 1369, 64 U.S.P.Q.2d 1448, 1453 (Fed. Cir. 2002) (Bogese 
II). Rather, the rules require that applicants who file multiple 
continuing applications from the same initial application show that the 
third and following applications, and any second or subsequent request 
for continued examination in an application family, be filed to obtain 
consideration of an amendment, argument, or evidence that could not 
have been previously submitted.
    Likewise, the Office is putting conditions on request for continued 
examination practice. 35 U.S.C. 132(b) provides for the request for 
continued examination practice set forth in Sec.  1.114. Unlike 
continuation application practice, the request for continued 
examination practice was recently added to title 35, United States 
Code, in section 4403 of the American Inventors Protection Act of 1999 
(AIPA). See Public Law 106-113, 113 Stat. 1501, 1501A-560 (1999). 35 
U.S.C. 132(b) provides, inter alia, that the Office ``shall prescribe 
regulations to provide for the continued examination of applications 
for patent at the request of the applicant.'' Nothing in 35 U.S.C. 
132(b) or its legislative history suggests that the Office must or even 
should permit an applicant to file an unlimited number of requests for 
continued examination in an application. Therefore, this final rule 
allows applicants to file their first request for continued examination 
in an application family without any justification, but requires 
applicants to justify the need for any further requests for continued 
examination in light of the past prosecution.
    The Office appreciates that appropriate continued examination 
practice permits an applicant to obtain further examination and advance 
an application to final action. The unrestricted continued examination 
practice, however, does not provide adequate incentives to assure that 
the exchanges between an applicant and the examiner during the 
examination process are efficient. The marginal value vis-[agrave]-vis 
the patent examination process as a whole of exchanges between an 
applicant and the examiner during the examination process tends to 
decrease after each additional continued examination filing. The Office 
resources absorbed by the examination of additional continued 
examination filings are diverted away from the examination of new 
applications, thus increasing the backlog of unexamined applications.
    The Office also appreciates that applicants sometimes use continued 
examination practice to obtain further examination rather than file an 
appeal to avoid the delays that historically have been associated with 
the appeal process. The Office, however, has taken major steps to 
eliminate such delays. First, the Board of Patent Appeals and 
Interferences (BPAI) has radically reduced the inventory of pending 
appeals and appeal pendency during the last five fiscal years. Second, 
the Office has adopted an appeal conference program to review the 
rejections in applications in which an appeal brief has been filed. See 
Manual of Patent Examining Procedure (MPEP) Sec.  1207.01 (8th ed. 
2001) (Rev. 5, August 2006). Third, the Office has also adopted a pre-
appeal brief conference program to permit an applicant to request that 
a panel of examiners review the rejections in his or her application 
prior to the filing of an appeal brief. See New Pre-Appeal Brief 
Conference Program, 1296 Off. Gaz. Pat. Office 67 (July 12, 2005), and 
Extension of the Pilot Pre-Appeal Brief Conference Program, 1303 Off. 
Gaz. Pat. Office 21 (Feb. 7, 2006). These changes provide for a 
relatively expeditious review of rejections in an application under 
appeal. Thus, for an applicant faced with a rejection that he or she 
feels is improper, the appeal process offers a more effective 
resolution than seeking continued examination before the examiner.
    This final rule also provides that an applicant may file a 
divisional application directed to each non-elected invention that has 
not been examined if the prior-filed application is subject to a 
requirement for restriction. The divisional application need not be 
filed during the pendency of the application subject to a requirement 
for restriction, as long as the copendency requirement of 35 U.S.C. 120 
is met. This final rule also permits applicant to file two continuation 
applications of a divisional application plus a request for continued 
examination in the divisional application family, without any 
justification. This final rule, however, does not permit a 
``divisional'' application to be filed if it is not the result of a 
requirement for restriction in the prior-filed application (a so-called 
``voluntary'' divisional application). Such a ``voluntary'' divisional 
application would be a continuation application, and subject to the 
requirements for continuation applications, under the changes in this 
final rule.

B. Changes to Practice for Examination of Claims in Patent Applications

    A number of patent applications contain a large number of claims, 
which makes efficient and effective

[[Page 46721]]

examination of such applications problematic. The Office previously 
requested comments in 1998 on a proposal to limit the number of 
independent and total claims that would be examined in an application. 
See Changes to Implement the Patent Business Goals, 63 FR 53497, 53506-
08 (Oct. 5, 1998), 1215 Off. Gaz. Pat. Office 87, 95-97 (Oct. 27, 
1998). Specifically, in 1998, the Office requested comments on a 
proposal to change the rules of practice to: (1) Limit the number of 
total claims that will be examined (at one time) in an application to 
forty; and (2) limit the number of independent claims that will be 
examined (at one time) in an application to six. See Changes to 
Implement the Patent Business Goals, 63 FR at 53506, 1215 Off. Gaz. 
Pat. Office at 95. Under the 1998 proposal, if the applicant presented 
more than forty total claims or six independent claims for examination 
at one time, the Office would withdraw the excess claims from 
consideration, and require the applicant to cancel those claims. See 
id. The Office, however, ultimately decided not to proceed with a 
proposed change to Sec.  1.75 to place an absolute limit on the number 
of total and independent claims that would be examined in an 
application. See Changes to Implement the Patent Business Goals, 64 FR 
53771, 53774-75 (Oct. 4, 1999), 1228 Off. Gaz. Pat. Office 15, 17-18 
(Nov. 2, 1999).
    Applications which contain a large number of claims, however, 
continue to absorb an inordinate amount of patent examining resources, 
as they are extremely difficult to properly process and examine. As a 
result, contrary to the proposal under consideration in 1998, the 
Claims Proposed Rule sought a change to the practice for examination of 
claims that would not place a limit on the number of total or 
independent claims that may be presented for examination in an 
application. The Office proposed in the Claims Proposed Rule to revise 
the practice for the examination of claims in an application as 
follows: (1) The Office would give an initial examination only to the 
representative claims, namely, all of the independent claims and only 
the dependent claims that are expressly designated for initial 
examination; and (2) if the number of representative claims is greater 
than ten, the Office would require the applicant to help focus 
examination by submitting an examination support document covering all 
of the representative claims. See Changes to Practice for the 
Examination of Claims in Patent Applications, 71 FR at 61-69, 1302 Off. 
Gaz. Pat. Office at 1329-35.
    The Office received a substantial number of comments from the 
public opposing the proposed ``representative claims'' examination 
approach and suggesting that the Office should simply adopt a strategy 
based upon whether an application contains more than a given number of 
independent and total claims. As a result of the public comments on the 
Claims Proposed Rule, the Office is not adopting the ``representative 
claims'' examination approach.
    Instead, this final rule provides that if the number of independent 
claims is greater than five or the number of total claims is greater 
than twenty-five, the applicant must help focus examination by 
providing an examination support document covering all of the claims in 
the application (whether in independent or dependent form) before the 
issuance of a first Office action on the merits of an application. An 
applicant may present up to five independent claims and twenty-five 
total claims in an initial application and each continuation or 
continuation-in-part application without providing either an 
examination support document or justification, as long as those 
applications are either prosecuted serially or contain patentably 
distinct claims. Thus, an applicant may present up to fifteen 
independent claims and seventy-five total claims to a single patentably 
distinct invention via an initial application and two continuation or 
continuation-in-part applications that are filed and prosecuted 
serially without providing either an examination support document or a 
justification. Furthermore, an applicant may present up to fifteen 
independent claims and seventy-five total claims via a divisional 
application and its two continuation applications without providing 
either an examination support document or a justification, if the 
Office issues a restriction requirement in the prior-filed application. 
Thus, the change to the practice for examination of claims adopted in 
this final rule avoids placing a limit on the number of total or 
independent claims that may be presented for examination in an 
application, but does require an applicant who presents more than five 
independent claims or more than twenty-five total claims in an 
application to help focus examination by providing additional 
information to the Office in an examination support document.
    If an applicant thinks fifteen independent claims or seventy-five 
total claims to an invention is not sufficient, or if applicant wishes 
to present more than five independent claims or twenty-five total 
claims in any one application, then applicant has the option of 
presenting as many independent and total claims as desired by providing 
an examination support document. The examination support document will 
assist the examiner in examining the application and determining the 
patentability of a claimed invention by providing the most relevant 
prior art and other useful information. Specifically, the examination 
support document will assist the examiner in understanding the 
invention and interpreting the claims before conducting a prior art 
search. The examination support document will also assist the examiner 
in evaluating the prior art cited by the applicant and in determining 
whether a claim limitation has support in the original disclosure and 
in any prior-filed application. An examination support document must be 
filed before the issuance of a first Office action on the merits of an 
application. This is so that the information concerning the invention 
will be available when the Office begins the examination process, and 
thus avoids the piecemeal examination that would result if the 
examination support document were not provided until after the first 
Office action on the merits in the application.

C. Changes to Practice for Patent Applications Containing Patentably 
Indistinct Claims

    The changes in this final rule also require that applicants provide 
additional information to the Office when they file multiple 
applications containing ``conflicting'' or patentably indistinct 
claims. The rules of practice provided that ``[w]here two or more 
applications filed by the same applicant contain conflicting claims, 
elimination of such claims from all but one application may be required 
in the absence of good and sufficient reason for their retention during 
pendency in more than one application.'' See 37 CFR 1.78(b) (2006).
    This final rule provides that an applicant must identify other 
pending applications or patents that are commonly owned, have a common 
inventor, and have a claimed filing or priority date within two months 
of the claimed filing or priority date of the application. This 
requirement does not supplant an applicant's duty to bring other 
applications that are ``material to patentability'' of an application 
(e.g., applications containing patentably indistinct claims) to the 
attention of the examiner. See Dayco Prod., Inc. v. Total

[[Page 46722]]

Containment, Inc., 329 F.3d 1358, 1365-69, 66 U.S.P.Q.2d 1801, 1806-08 
(Fed. Cir. 2003); see also MPEP Sec.  2001.06(b). Thus, applicants are 
cautioned against intentionally filing related applications outside of 
this two-month window in an attempt to avoid the requirement to 
identify other applications that are material to the patentability of 
the application at issue. See Cargill, Inc. v. Canbra Foods, Ltd., 476 
F.3d 1359, 1367-68, 81 U.S.P.Q.2d 1705, 1711 (Fed. Cir. 2007) (there is 
no such thing as a good faith intent to deceive).
    This final rule provides that if there are other pending 
applications or patents that are commonly owned and have a common 
inventor, substantial overlapping disclosures, and the same claimed 
filing or priority date, the Office will presume that the applications 
contain patentably indistinct claims. In such a situation, the 
applicant must either rebut this presumption by explaining how the 
applications contain patentably distinct claims, or submit the 
appropriate terminal disclaimers and explain why two or more pending 
applications containing ``conflicting'' or patentably indistinct claims 
should be maintained.
    The Office proposed a provision that if an application contains at 
least one claim that is patentably indistinct from at least one claim 
in one or more other applications or patents, the Office would (if 
certain conditions were met) treat the independent claims and the 
dependent claims designated for initial examination in the first 
application and in each of such other applications or patents as 
present in each of the applications for purposes of determining whether 
the applicant would be required to submit an examination support 
document. See Changes to Practice for the Examination of Claims in 
Patent Applications, 71 FR at 64, 68, 1302 Off. Gaz. Pat. Office at 
1331, 1334. This final rule provides that if multiple applications, 
including applications having a continuity relationship, contain 
patentably indistinct claims, the Office will treat the multiple 
applications as a single application for purposes of determining 
whether each of the multiple applications exceeds the five independent 
claim and twenty-five total claim threshold. This provision is to 
preclude an applicant from submitting multiple applications with claims 
that are patentably indistinct, each with five or fewer independent 
claims or twenty-five or fewer total claims, for the purposes of 
avoiding the requirement to submit an examination support document in 
compliance with Sec.  1.265. The Office, however, will not count the 
claims in issued patents that contain patentably indistinct claims in 
determining whether a pending application exceeds the five independent 
claim and twenty-five total claim threshold. Nevertheless, those 
patentably indistinct claims would still be subject to a double 
patenting rejection.

D. Retention of First Action Final Practice and Changes in Second 
Action Final Practice

    The Office has a first action final rejection practice under which 
the first Office action in a continuing application, or in the 
prosecution of a request for continued examination, may be made final 
under certain circumstances. See MPEP Sec.  706.07(b) and 706.07(h), 
paragraph VIII. The Office proposed to eliminate this practice in 
continuing applications under 35 U.S.C. 120, 121, or 365(c) and in 
requests for continued examination under 35 U.S.C. 132(b) as 
unnecessary in view of the proposed changes to continuing applications 
and requests for continued examination practice that would permit an 
applicant to file only one continuing application or request for 
continued examination without any justification. See Changes to 
Practice for Continuing Applications, Requests for Continued 
Examination Practice, and Applications Containing Patentably Indistinct 
Claims, 71 FR at 51, 1302 Off. Gaz. Pat. Office at 1321. This final 
rule, however, provides that an applicant may file a request for 
continued examination in either the initial application or either of 
the two continuing applications without any justification. Therefore, 
the Office is retaining its first action final rejection practice. 
Applicants, however, are reminded that it would not be proper for the 
Office to make a first Office action final in a continuing application 
or after a request for continued examination if the application 
contains material which was presented after final rejection or the 
close of prosecution but was denied entry because: (1) new issues were 
raised that required further consideration and/or search; or (2) the 
issue of new matter was raised. See MPEP Sec.  706.07(b) and 706.07(h). 
Thus, applicants may guard against first action final rejection in a 
continuing application or after a request for continued examination by 
first seeking entry of the amendment, argument, or new evidence under 
Sec.  1.116.
    The Office is also not changing the final action practice for the 
Office action following a submission under Sec.  1.129(a). See Changes 
to the Transitional Procedures for Limited Examination After Final 
Rejection in Certain Applications Filed Before June 8, 1995, 70 FR 
24005 (May 6, 2005), 1295 Off. Gaz. Pat. Office 22 (Jun. 7, 2005) 
(notice).
    The Office is revising second action final practice as it pertains 
to second or subsequent Office actions that include a new double 
patenting rejection (either statutory or obviousness-type double 
patenting). Double patenting can arise when a party (or parties to a 
joint research agreement under the Cooperative Research and Technology 
Enhancement Act of 2004 (CREATE Act), Public Law 108-453, 118 Stat. 
3596 (2004)) has filed multiple patent applications containing 
patentably indistinct claims. The applicant (or the owner of the 
application) is in a far better position than the Office to determine 
whether there are one or more other applications or patents containing 
patentably indistinct claims. For this reason, when an applicant files 
multiple applications that are substantially the same, the applicant is 
responsible for assisting the Office in resolving potential double 
patenting situations, rather than taking no action until faced with a 
double patenting rejection. Thus, if an Office action must include a 
double patenting rejection, it is because the applicant has not met his 
or her responsibility to resolve the double patenting situation. 
Therefore, the inclusion of a new double patenting rejection in a 
second or subsequent Office action will not preclude the Office action 
from being made final.
    The Office is also revising second action final practice as it 
pertains to second or subsequent Office actions that include a new 
ground of rejection necessitated by a showing that a claim element that 
does not use the phrase ``means for'' or ``step for'' is nevertheless a 
means- (or step-) plus-function claim element under 35 U.S.C. 112, ] 6. 
The Office revised the examination guidelines for means- (or step-) 
plus-function claim elements under 35 U.S.C. 112, ] 6, in June of 2000. 
See Supplemental Examination Guidelines for Determining the 
Applicability of 35 U.S.C. 112,  6, 65 FR 38510 (June 21, 
2000), 1236 Off. Gaz. Pat. Office 98 (July 25, 2000) (2000 Examination 
Guidelines); see also Interim Supplemental Examination Guidelines for 
Determining the Applicability of 35 U.S.C. 112,  6, 64 FR 
41392 (July 30, 1999). The 2000 Examination Guidelines for means- (or 
step-) plus-function claim elements under 35 U.S.C. 112, ] 6, have been 
incorporated into the MPEP. See MPEP sections 2181-2184 (8th ed. 2001) 
(Rev. 5, August 2006). The 2000 Examination

[[Page 46723]]

Guidelines set forth a three-prong procedure for determining whether a 
claim element is a means- (or step-) plus-function claim element under 
35 U.S.C. 112, ] 6. See Supplemental Examination Guidelines for 
Determining the Applicability of 35 U.S.C. 112,  6, 65 FR at 
38514, 1236 Off. Gaz. Pat. Office at 101. The 2000 Examination 
Guidelines provide that if a claim element does not include the phrase 
``means for'' or ``step for'' as provided in the first prong of the 
three-prong procedure and the applicant wishes to have the claim 
element treated under 35 U.S.C. 112, ] 6, in a proceeding before the 
Office, the applicant has two options: (1) Amend the claim to include 
the phrase ``means for'' or ``step for''; or (2) show that even though 
the phrase ``means for'' or ``step for'' is not used, the claim element 
is written as a function to be performed and does not recite sufficient 
structure, material, or acts which would preclude application of 35 
U.S.C. 112, ] 6. See Supplemental Examination Guidelines for 
Determining the Applicability of 35 U.S.C. 112,  6, 65 FR at 
38514, 1236 Off. Gaz. Pat. Office at 101. To avoid any unnecessary 
delay in the prosecution of the application, an applicant who wishes to 
have a claim element treated under 35 U.S.C. 112, ] 6, should either 
use the phrase ``means for'' or ``step for'' in the claim element or 
provide the necessary showing before the examination of the application 
begins so that the examiner can properly interpret the claims in the 
application and make a patentability determination. Furthermore, 
because submitting a showing is tantamount to an amendment of the claim 
to include the phrase ``means for'' or ``step for,'' a showing will be 
treated as an amendment of the claim for second action final purposes. 
Thus, the inclusion of a new rejection in a second or subsequent Office 
action necessitated by a showing submitted by applicant will not 
preclude the Office from making the second or subsequent Office action 
final.
    This final rule requires applicant to identify any claims in a 
continuation-in-part application for which the subject matter is 
disclosed in the manner provided by 35 U.S.C. 112, ] 1, in the prior-
filed application. See Sec.  1.78(d)(3) and the discussion of Sec.  
1.78(d)(3). Any claim in the continuation-in-part application for which 
the subject matter is not identified as being disclosed in the manner 
provided by 35 U.S.C. 112, ] 1, in the prior-filed application will be 
treated as entitled only to the actual filing date of the continuation-
in-part application, and will be subject to prior art based on the 
actual filing date of the continuation-in-part application. To avoid 
any unnecessary delay in the prosecution of the application, applicant 
should provide the identification before the examiner begins to conduct 
a prior art search. If the failure to identify the claims for which the 
subject matter is disclosed in the manner provided by 35 U.S.C. 112, ] 
1, in the prior-filed application causes the examiner to include a new 
prior art rejection in a second or subsequent Office action, the 
inclusion of the new prior art rejection will not preclude the Office 
action from being made final.
    Therefore, the Office is revising second action final practice to 
provide that a second or any subsequent Office action on the merits may 
be made final, except when the Office action contains a new ground of 
rejection that is not: (1) Necessitated by applicant's amendment of the 
claims, including amendment of a claim to eliminate unpatentable 
alternatives; (2) necessitated by applicant's providing a showing that 
a claim element that does not use the phrase ``means for'' or ``step 
for'' is written as a function to be performed and does not otherwise 
preclude application of 35 U.S.C. 112, ] 6; (3) based on information 
submitted in an information disclosure statement filed during the 
period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 
1.17(p); (4) based upon double patenting (statutory or obviousness-type 
double patenting); or (5) necessitated by applicant's identification of 
the claim or claims in a continuation-in-part application for which the 
subject matter is disclosed in the manner provided by 35 U.S.C. 112, ] 
1, in the prior-filed application. The provision in MPEP Sec.  904.02 
that a search should cover the claimed subject matter and should also 
cover the disclosed features which might reasonably be expected to be 
claimed does not preclude an examiner from making the second or any 
subsequent Office action on the merits final if the Office action 
contains a new ground of rejection that was necessitated solely by 
applicant's amendment of the claims to eliminate an unpatentable 
alternative. An examiner cannot be expected to foresee whether or how 
an applicant will amend a claim to overcome a rejection except in very 
limited circumstances (e.g., where the examiner suggests how applicant 
can overcome a rejection under 35 U.S.C. 112, ] 2).

II. Discussion of Specific Rules

    Title 37 of the Code of Federal Regulations, part 1, is amended as 
follows:
    Section 1.17 (patent application and reexamination processing 
fees): Section 1.17(f) is amended to include a reference to: (1) 
Petitions under Sec.  1.78(d)(1)(vi) for a continuing application not 
provided for in Sec. Sec.  1.78(d)(1)(i) through (d)(1)(v); and (2) 
petitions under Sec.  1.114(g) for a request for continued examination 
not provided for in Sec.  1.114(f). See discussion of Sec. Sec.  1.78 
and 1.114.
    Section 1.26 (refunds): Section 1.26(a) is amended to add the 
phrase ``[e]xcept as provided in Sec.  1.117 or Sec.  1.138(d)'' to the 
sentence ``[a] change of purpose after the payment of a fee, such as 
when a party desires to withdraw a patent filing for which the fee was 
paid, including an application, an appeal, or a request for an oral 
hearing, will not entitle a party to a refund of such fee.'' The 
``change of purpose'' provision of Sec.  1.26(a) is directed to the 
provision in 35 U.S.C. 42(d) authorizing a refund of ``any fee paid by 
mistake or any amount paid in excess of that required.'' 35 U.S.C. 
42(d). Sections 1.117 and 1.138(d), however, are directed to the 
provisions in 35 U.S.C. 41(a)(2) and (d)(1)(D) as amended by the 
Consolidated Appropriations Act, 2005 (Consolidated Appropriations Act) 
that permit the Office to develop procedures to refund search fees or 
excess claims fees under certain limited conditions. See Public Law 
108-447, 118 Stat. 2809 (2004). Section 1.26(b) is amended to change 
``except as otherwise provided in this paragraph or in Sec.  1.28(a)'' 
to ``except as otherwise provided in this paragraph, or in Sec.  
1.28(a), Sec.  1.117(b), or Sec.  1.138(d)''. This change is for 
consistency with Sec.  1.117(b) and Sec.  1.138(d), which also specify 
time periods within which certain refunds must be requested.
    Section 1.52 (language, paper, writing, margins, compact disc 
specifications): Section 1.52(d)(2) is amended to refer to Sec.  
1.78(b) concerning the requirements for claiming the benefit of a 
provisional application in a nonprovisional application. Section 
1.52(d)(2) is also amended to provide that if a provisional application 
is filed in a language other than English and the benefit of such 
provisional application is claimed in a nonprovisional application, an 
English language translation of the non-English language provisional 
application will be required in the provisional application. This 
change conforms Sec.  1.52(d)(2) to the September 2005 revision to the 
provisions in Sec.  1.78 for claiming the benefit of a provisional 
application. See Provisions for Claiming the Benefit of a Provisional 
Application With a Non-English Specification and Other Miscellaneous 
Matters, 70 FR 56119,

[[Page 46724]]

56121, 56128 (Sept. 26, 2005), 1299 Off. Gaz. Pat. Office 142, 143-44, 
150 (Oct. 25, 2005) (final rule). With respect to claiming the benefit 
of a provisional application that was filed in a language other than 
English, Sec.  1.78(b)(5) now provides that: (1) If the prior-filed 
provisional application was filed in a language other than English and 
both an English-language translation of the prior-filed provisional 
application and a statement that the translation is accurate were not 
previously filed in the prior-filed provisional application, applicant 
will be notified and given a period of time within which to file the 
translation and the statement in the prior-filed provisional 
application; (2) if the notice is mailed in a pending nonprovisional 
application, a timely reply to such a notice must include the filing in 
the nonprovisional application of either a confirmation that the 
translation and statement were filed in the provisional application, or 
an amendment or supplemental application data sheet withdrawing the 
benefit claim, or the nonprovisional application will be abandoned; and 
(3) the translation and statement may be filed in the provisional 
application, even if the provisional application has become abandoned.
    Section 1.53 (application number, filing date, and completion of 
application): Section 1.53(b) and (c)(4) are amended to refer to Sec.  
1.78, rather than specific paragraphs of Sec.  1.78. Section 1.53(b)(1) 
is also amended to provide that continuation or divisional applications 
naming an inventor not named in the prior application must be filed 
under Sec.  1.53(b) (this provision was formerly in Sec.  1.53(b)(2)), 
and to reference Sec.  1.78(a)(2) for the definition of a divisional 
application and Sec.  1.78(a)(3) for the definition of a continuation 
application. Section 1.53(b)(2) is amended to reference Sec.  
1.78(a)(4) for the definition of a continuation-in-part application.
    Section 1.75 (claims): Section 1.75(b) is amended to provide for 
the revised practice for the examination of claims in an application. 
Section 1.75(b) (introductory text) provides for the requirements of a 
dependent claim. Section 1.75(b)(1) provides for the five independent 
claim and twenty-five total claim threshold for invoking the 
examination support document requirement. Section 1.75(b)(2) provides 
for claims in dependent form that are effectively independent claims. 
Section 1.75(b)(3) provides for situations in which an examination 
support document has not been provided in an application that exceeds 
the five independent claim and twenty-five total claim threshold. 
Section 1.75(b)(4) provides that the total number of claims present in 
all of the copending commonly owned applications that contain 
patentably indistinct claims may not exceed the five independent claim 
and twenty-five total claim threshold. Section 1.75(b)(5) provides that 
claims withdrawn from consideration will not, unless they are 
reinstated or rejoined, be taken into account in determining whether an 
application exceeds the five independent claim and twenty-five total 
claim threshold. Section 1.75(c) is amended to provide that multiple 
dependent claims and claims depending from a multiple dependent claim 
will be considered to be that number of claims to which direct 
reference is made in the multiple dependent claim for claims counting 
purposes.
    Section 1.75(b) (introductory text) is amended to set forth the 
existing provisions concerning dependent claims in Sec.  1.75(c), 
namely, that ``[o]ne or more claims may be presented in dependent form, 
referring back to and further limiting another claim or claims in the 
same application.'' Section 1.75(b) (introductory text) is also amended 
to clarify that a dependent claim is required to incorporate by 
reference all the limitations of the previous claim to which it refers 
and to specify a further limitation of the subject matter of the 
previous claim. See Pfizer Inc. v. Ranbaxy Labs. Ltd., 437 F.3d 1284, 
1292, 79 U.S.P.Q.2d 1583, 1589-90 (Fed. Cir. 2006) (a dependent claim 
is required to include all the limitations of the claim from which it 
depends and the failure to incorporate by reference all the limitations 
is a violation of 35 U.S.C. 112, ] 4, and renders the dependent claim 
invalid).
    Section 1.75(b)(1) provides that an applicant must file an 
examination support document in compliance with Sec.  1.265 that covers 
each claim (whether in independent or dependent form) before the 
issuance of a first Office action on the merits of the application if 
the application contains or is amended to contain more than five 
independent claims or more than twenty-five total claims. Section 
1.75(b)(1) also provides that the application may not contain or be 
amended to contain more than five independent claims or more than 
twenty-five total claims if an examination support document in 
compliance with Sec.  1.265 has not been filed before the issuance of a 
first Office action on the merits of an application. The examination 
support document in compliance with Sec.  1.265 is required to be filed 
before the issuance of the first Office action on the merits of the 
application because the information provided by the applicant in the 
examination support document will assist the examiner in understanding 
the invention of the application, determining the effective filing date 
of each claim, interpreting the claims before a prior art search, 
understanding the state of the art and the most closely related prior 
art cited by the applicant, and determining the patentability of the 
claims. Applicant is permitted to present more than five independent 
claims or more than twenty-five total claims in a continuing 
application, if the applicant files an examination support document in 
compliance with Sec.  1.265 before the first Office action on the 
merits of the continuing application, regardless of whether an 
examination support document has been filed in the prior-filed 
application.
    Claims withdrawn from consideration under Sec. Sec.  1.141 through 
1.146 or Sec.  1.499 as drawn to a non-elected invention or inventions 
are not taken into account in determining whether an application 
exceeds this five independent claim and twenty-five total claim 
threshold. See Sec.  1.75(b)(5) and discussion of Sec.  1.75(b)(5).
    Section 1.75(b)(2) concerns claims in dependent form that are 
effectively independent claims. Section 1.75(b)(2) provides that a 
claim that refers to another claim but does not incorporate by 
reference all the limitations of the claim to which such claim refers 
will be treated as an independent claim for fee calculation purposes 
under Sec.  1.16 (or Sec.  1.492) and for purposes of Sec.  1.75(b). 
The Office must treat such claims as independent claims because 35 
U.S.C. 112, ] 4, provides (inter alia) that a dependent claim ``shall 
be construed to incorporate by reference all the limitations of the 
claim to which it refers.'' See 35 U.S.C. 112, ] 4. For examples of 
such claims, see: In re Thorpe, 777 F.2d 695, 696, 227 U.S.P.Q. 964, 
965 (Fed. Cir. 1985) (``product by process'' claim 44); In re Kuehl, 
475 F.2d 658, 659, 177 U.S.P.Q. 250, 251 (C.C.P.A. 1973) (claim 6); and 
Ex parte Rao, 1995 WL 1747720, *1 (BPAI 1998) (claim 8). Section 
1.75(b)(2) also provides that a claim that refers to a claim of a 
different statutory class of invention will be treated as an 
independent claim for fee calculation purposes under Sec.  1.16 (or 
Sec.  1.492) and for purposes of Sec.  1.75(b). For examples of such 
claims, see: Thorpe, 777 F.2d at 696, 227 U.S.P.Q. at 965 (``product by 
process'' claim 44); Ex parte Porter, 25 U.S.P.Q.2d 1144, 1145 (BPAI 
1992) (claim 6); and Ex parte Blattner, 2

[[Page 46725]]

U.S.P.Q.2d 2047, 2047-48 (BPAI 1987) (claim 14).
    Section 1.75(b)(3) provides that the applicant will be notified if 
the application contains or is amended to contain more than five 
independent claims or more than twenty-five total claims but the 
applicant has not complied with the requirements set forth in Sec.  
1.75(b)(1) or 1.75(b)(4) (e.g., an examination support document in 
compliance with Sec.  1.265 has been omitted). Section 1.75(b)(3) also 
provides that if the non-compliance appears to have been inadvertent, 
the notice will set a two-month time period that is not extendable 
under Sec.  1.136(a) within which, to avoid abandonment of the 
application, the applicant must comply with the requirements set forth 
in Sec.  1.75(b). Again, claims withdrawn from consideration under 
Sec. Sec.  1.141 through 1.146 or Sec.  1.499 as drawn to a non-elected 
invention or inventions are not taken into account in determining 
whether an application exceeds this five independent claim and twenty-
five total claim threshold. See Sec.  1.75(b)(5) and discussion of 
Sec.  1.75(b)(5).
    If a notice under Sec.  1.75(b)(3) is mailed before the first 
Office action on the merits of an application and it appears that the 
omission of an examination support document was inadvertent, the notice 
will set a two-month time period within which the applicant must: (1) 
File an examination support document in compliance with Sec.  1.265 
that covers each claim (whether in independent or dependent form); or 
(2) amend the application such that it contains no more than five 
independent claims and no more than twenty-five total claims. Section 
1.75(b)(3) provides that this two-month time period is not extendable 
under Sec.  1.136(a) and that the failure to reply to such a notice 
will result in abandonment of the application. Due to the increase in 
patent pendency that would result from the routine granting of 
extensions in the situation in which an application contains or is 
amended to contain more than five independent claims or more than 
twenty-five total claims but the applicant has not complied with the 
requirements set forth in Sec.  1.75(b)(1) or 1.75(b)(4) (e.g., an 
examination support document in compliance with Sec.  1.265 has been 
omitted), the Office is limiting extensions of this two-month time 
period in Sec.  1.75(b)(3) to those for which there is sufficient cause 
(Sec.  1.136(b)).
    Once the Office issues a notice under Sec.  1.75(b)(3), the 
applicant may not simply submit a suggested alternative requirement for 
restriction under Sec.  1.142(c), but instead must: (1) File an 
examination support document in compliance with Sec.  1.265 that covers 
each claim (whether in independent or dependent form); or (2) amend the 
application such that it contains no more than five independent claims 
and no more than twenty-five total claims.
    If an examination support document in compliance with Sec.  1.265 
as required under Sec.  1.75(b) was not filed before the issuance of a 
first Office action on the merits of an application, an amendment that 
results in the application containing more than five independent claims 
or more than twenty-five total claims will be treated as non-
responsive. Specifically, if the non-compliance with Sec.  1.75(b) 
appears to have been inadvertent, the Office would give the applicant a 
two-month time period that is not extendable under Sec.  1.136(a) 
within which to provide an amendment that does not result in the 
application containing more than five independent claims or more than 
twenty-five total claims. See Sec.  1.135(c) (``[w]hen reply by the 
applicant is a bona fide attempt to advance the application to final 
action, and is substantially a complete reply to the non-final Office 
action, but consideration of some matter or compliance with some 
requirement has been inadvertently omitted, applicant may be given a 
new time period for reply under Sec.  1.134 to supply the omission.'').
    Section 1.75(b)(4) provides for the situation in which: (1) A 
nonprovisional application contains at least one claim that is 
patentably indistinct from at least one claim in one or more other 
pending nonprovisional applications; and (2) the nonprovisional 
application and the one or more other pending nonprovisional 
applications either are owned by the same person or are subject to an 
obligation of assignment to the same person. In this situation, Sec.  
1.75(b)(4) provides that the Office will treat the claims in the first 
nonprovisional application and in each of such other pending 
nonprovisional applications as being present in each of the pending 
nonprovisional applications for purposes of Sec.  1.75(b). That is, if 
the conditions specified in Sec.  1.75(b)(4) are present, the Office 
will treat each such nonprovisional application as having the total 
number of claims present in all of such applications (and not just the 
claim that is patentably indistinct) for purposes of determining 
whether an examination support document is required by Sec.  1.75(b). 
For example: If application ``A'' contains only one claim that is 
patentably indistinct from the claims in application ``B'', application 
``A'' and application ``B'' are owned by the same company, and each 
application contains three independent claims and twenty total claims, 
the Office will treat each application as having six independent claims 
and forty total claims in determining whether each application exceeds 
the five independent claim and twenty-five total claim threshold set 
forth in Sec.  1.75(b). In this example, an examination support 
document would be required in each application before the issuance of a 
first Office action on the merits of the application. To avoid the 
provisions of Sec.  1.75(b)(4), applicant may present all of the 
patentably indistinct claims in application ``B'' by canceling the 
patentably indistinct claim from application ``A''. As discussed 
previously, Sec.  1.75(b)(4) is to preclude an applicant from 
submitting multiple applications to the same subject matter (with 
claims that are patentably indistinct), each with five or fewer 
independent claims or twenty-five or fewer total claims, for the 
purpose of avoiding the requirement to submit an examination support 
document in compliance with Sec.  1.265.
    Under Sec.  1.75(b)(4), the Office will count the claims in the 
copending nonprovisional applications containing patentably indistinct 
claims (including applications having a continuity relationship) but 
not in issued patents containing patentably indistinct claims, in 
determining whether each such application exceeds the five independent 
claim or twenty-five total claim threshold for invoking the examination 
support document requirement. An applicant may present up to five 
independent claims and twenty-five total claims in an initial 
application and each continuing application, provided that continuing 
applications that contain patentably indistinct claims are not 
prosecuted in parallel with the initial application or each other. 
Thus, an applicant may present up to fifteen independent claims and 
seventy-five total claims to a single invention via an initial 
application and two continuing applications that are filed and 
prosecuted serially without providing either an examination support 
document or a justification. In addition, an applicant may prosecute a 
divisional application (an application containing claims that are 
patentably distinct from the claims to the invention prosecuted in the 
initial application) in parallel with the initial application or its 
continuation or continuation-in-part applications without the claims in 
the divisional application being taken into account in determining 
whether the initial application or its continuation or continuation-in-
part applications

[[Page 46726]]

exceed the five independent claim or twenty-five total claim threshold 
for invoking the examination support document requirement.
    Section 1.75(b)(4) also provides that the total number of claims 
present in all of such copending nonprovisional applications containing 
patentably indistinct claims may not exceed five independent claims or 
twenty-five total claims unless an examination support document in 
compliance with Sec.  1.265 is filed before the issuance of a first 
Office action on the merits of the application containing patentably 
indistinct claims.
    The provisions of Sec.  1.75(b)(4) do not depend upon the relative 
filing dates of the nonprovisional application and the one or more 
other nonprovisional applications. The provisions of Sec.  1.75(b)(4) 
apply regardless of whether the filing dates of the applications are 
the same, are within two months of each other (cf. Sec.  1.78(f)(1) and 
(f)(2)), or are not within two months of each other. In other words, 
the provision of Sec.  1.75(b)(4) does not depend on the filing dates 
of the respective applications. In addition, the provisions of Sec.  
1.75(b)(4) are applicable regardless of any continuity relationship 
between the applications (e.g., the provision applies if a parent 
application is still pending at the time the child application is under 
examination). For applications having a continuity relationship, the 
prior application must be pending at the time the continuing 
application is filed. See 35 U.S.C. 120 (requires that a continuing 
application be filed before the patenting or abandonment of or 
termination of proceedings on the prior application). The Office, 
however, will treat the application as no longer pending for purposes 
of Sec.  1.75(b)(4) if: (1) A notice of allowance is issued, unless the 
application is withdrawn from issue (Sec.  1.313); (2) the Office 
recognizes the application is abandoned; (3) a notice of appeal to the 
U.S. Court of Appeals for the Federal Circuit under 35 U.S.C. 141 is 
filed, unless the appeal is terminated; or (4) a civil action under 35 
U.S.C. 145 or 146 is commenced, unless the civil action is terminated.
    Section 1.75(b)(4) as adopted in this final rule differs from 
proposed Sec.  1.75(b)(4) in that it does not provide that the Office 
may require elimination of the patentably indistinct claims from all 
but one of the applications. Such a provision would be a substantial 
duplicate of Sec.  1.78(f)(3) as adopted in this final rule, which 
provides that if the conditions set forth in Sec.  1.75(b)(4) exist, 
the Office may require elimination of the patentably indistinct claims 
from all but one of the applications in the absence of good and 
sufficient reason for there being two or more such nonprovisional 
applications containing patentably indistinct claims.
    Section 1.75(b)(5) provides that claims withdrawn from 
consideration under Sec. Sec.  1.141 through 1.146 or Sec.  1.499 as 
drawn to a non-elected invention or inventions will not, unless they 
are reinstated or rejoined, be taken into account in determining 
whether an application exceeds the five independent claim and twenty-
five total claim threshold set forth in Sec. Sec.  1.75(b)(1), (b)(3), 
and (b)(4). Thus, claims withdrawn from consideration as the result of 
an Office-initiated requirement under Sec.  1.142, 1.146, or 1.499 
(regardless of whether the election is with or without traverse), or as 
the result of the acceptance of a suggested restriction requirement 
under Sec.  1.142(c), are not taken into account in determining whether 
an application exceeds the five independent claim and twenty-five total 
claim threshold. In addition, claims withdrawn from consideration in an 
application (e.g., the initial application) as the result of either an 
Office-initiated requirement under Sec.  1.142, 1.146, or 1.499, or the 
acceptance of a suggested restriction requirement under Sec.  1.142(c), 
are not taken into account in determining whether a copending 
application (e.g., a continuation application of the initial 
application) contains a claim that is patentably indistinct from a 
claim in such application for purposes of Sec.  1.75(b)(4).
    Section 1.142(c) as adopted in this final rule provides that the 
applicant may submit a suggested requirement for restriction if two or 
more independent and distinct inventions are claimed in the 
application. Section 1.142(c) further provides that any suggested 
requirement for restriction must be filed before the earlier of the 
first Office action on the merits or any Office action that contains a 
requirement to comply with the requirement of unity of invention under 
PCT Rule 13 or a requirement for restriction (including an election of 
species) under 35 U.S.C. 121 in the application. Section 1.142(c) 
provides that any suggested requirement for restriction must also be 
accompanied by an election without traverse of an invention to which 
there are no more than five independent claims and no more than twenty-
five total claims, and identify the claims to the elected invention. If 
the applicant submits a suggested restriction requirement, the 
suggested restriction requirement is accepted, and there are five or 
fewer independent claims and twenty-five or fewer total claims to the 
elected invention (as required by Sec.  1.142(c)), the Office will 
simply treat the non-elected claims as withdrawn from consideration and 
proceed to act on the application (assuming the application is 
otherwise in condition for action). The Office action will set out the 
requirement for restriction under Sec.  1.141(a), e.g., in the manner 
that an Office action on the merits would contain a written record of a 
requirement for restriction previously made by telephone. See MPEP 
section 810. Applicants are reminded, however, that the Office may 
refund excess claims fees only for claims that are canceled prior to 
the issuance of a first Office action on the merits of the application. 
See 35 U.S.C. 41(a)(2) (``[t]he Director may, by regulation, provide 
for a refund of any part of the fee specified in [35 U.S.C. 41(a)(2)] 
for any claim that is canceled before an examination on the merits, as 
prescribed by the Director, has been made of the application under [35 
U.S.C.] 131'').
    If the applicant files a suggested requirement for restriction in 
an application containing more than five independent claims or more 
than twenty-five total claims, the applicant will also be notified if 
the suggested restriction requirement is not accepted. The refusal to 
accept a suggested requirement for restriction may result in the 
examiner making a different restriction requirement or making no 
restriction requirement.
    If the examiner makes a restriction requirement (which includes an 
election of species requirement) different from the suggested 
restriction requirement, the applicant will be notified of the 
restriction requirement. The applicant will be given a two-month time 
period that is not extendable under Sec.  1.136(a) within which the 
applicant must make an election consistent with the Office-issued 
restriction requirement in order to avoid abandonment of the 
application. Once the Office issues a requirement for restriction, the 
applicant may not simply submit a suggested alternative requirement for 
restriction under Sec.  1.142(c). Instead, the applicant must make an 
election (with or without traverse) responsive to the Office-issued 
requirement for restriction. If an application subject to an Office-
issued requirement for restriction contains more than five independent 
claims or more than twenty-five total claims, the reply must also 
either: (1) Amend the application to contain no more than five 
independent claims and no more than twenty-five total claims to the 
elected invention and/or species; or (2) include an examination support 
document in compliance with Sec.  1.265 that covers

[[Page 46727]]

each claim (whether in independent or dependent form) pending in the 
application.
    If the examiner does not make a restriction requirement, the 
applicant will simply be given a notice under Sec.  1.75(b)(3). That 
notice will set a two-month time period that is not extendable under 
Sec.  1.136(a) within which, to avoid abandonment of the application, 
the applicant must: (1) Amend the application to contain no more than 
five independent claims and no more than twenty-five total claims; or 
(2) file an examination support document in compliance with Sec.  1.265 
that covers each claim (whether in independent or dependent form) 
pending in the application. See Sec.  1.75(b)(3).
    Section 1.75(b)(5) also provides that claims reinstated (e.g., as a 
result of a request for reconsideration of the requirement) or rejoined 
(e.g., upon allowance of a generic claim) in the application are taken 
into account in determining whether an application exceeds the five 
independent claim and twenty-five total claim threshold. As discussed 
previously, unless an examination support document in compliance with 
Sec.  1.265 was filed before the issuance of a first Office action on 
the merits of an application, the application must remain at or under 
the five independent claim and twenty-five total claim threshold. 
Therefore, if an examination support document was not filed before the 
issuance of a first Office action on the merits of the application, and 
the reinstatement or rejoinder of non-elected claims results in the 
application containing more than five independent claims or more than 
twenty-five total claims, the Office will give the applicant a two-
month time period within which to amend the application to contain five 
or fewer independent claims and twenty-five or fewer total claims. See 
Sec.  1.75(b)(3). This two-month time period is not extendable under 
Sec.  1.136(a). The failure to file such an amendment will result in 
abandonment of the application.
    Since claims reinstated or rejoined in the application are taken 
into account in determining whether an application exceeds the five 
independent claim and twenty-five total claim threshold, applicants 
cannot rely upon a requirement for restriction to avoid submitting an 
examination support document before the issuance of a first Office 
action on the merits of an application. This is especially true where: 
(1) The applicant traverses the requirement for restriction; (2) the 
requirement for restriction may be conditional, such as a requirement 
for election of species in an application that contains a claim that is 
generic to all of the claimed species (hereafter ``generic claim'') 
(see MPEP section 809), or a requirement for restriction in an 
application that contains a linking claim (e.g., a subcombination claim 
linking plural combinations); or (3) the applicant plans to request 
rejoinder of the claims to the non-elected invention (see MPEP Sec.  
821.04 et seq.). Thus, applicants are advised to file an examination 
support document in the application before the first Office action on 
the merits if they anticipate the occurrence of any of the 
aforementioned three situations. Furthermore, applicants cannot rely 
upon the requirement for restriction to file a divisional application 
because the Office will withdraw the requirement for restriction, 
including an election of species, if the non-elected claims are 
reinstated or rejoined.
    Applicant is not permitted to file a divisional application of a 
prior-filed application that is no longer subject to a restriction 
requirement. Under Sec.  1.78(a)(2) and 1.78(d)(1)(ii), the prior-filed 
application to which a divisional application claims the benefit must 
be subject to a requirement to comply with the requirement of unity of 
invention under PCT Rule 13 or a requirement for restriction under 35 
U.S.C. 121. Sections 1.78(a)(2) and 1.78(d)(1)(ii) also require a 
divisional application to contain only claims directed to a non-elected 
invention that has not been examined.
    For an application that contains a generic claim in which a 
requirement for an election of species has been made, applicants should 
conclude prosecution (in the initial application and its continuation 
or continuation-in-part applications), including exhaustion of any 
available appeals, as to the generic claim before ever filing a 
divisional application to a non-elected species. If applicant no longer 
wants to pursue the generic claim, applicant may file a divisional 
application directed to a non-elected species. If an applicant files a 
divisional application directed to a non-elected species, applicant 
should: (1) Cancel the claims to the non-elected species and the 
generic claim in the prior-filed application before rejoinder or 
reinstatement occurs; (2) not present the non-elected claims and the 
generic claim in any continuation or continuation-in-part application 
of the initial application; and (3) not present the generic claim in 
the divisional application or any other continuation application of the 
divisional application (because the generic claim has been examined in 
the initial application and it is patentably indistinct from the claims 
of the non-elected species).
    When an application contains a generic claim and the examiner makes 
a provisional restriction requirement, requiring an election of species 
for initial search and examination purposes, the applicant must elect a 
single species. (The requirement is provisional because the restriction 
will be withdrawn upon allowance of the generic claim.) The examiner 
will determine the patentability of the elected species and generic 
claim. Upon the allowance of the generic claim, the provisional 
restriction requirement will be withdrawn, as explained above. The 
claims of the non-elected species then will be rejoined. The Office 
will count the rejoined claims together with the other pending claims 
to determine whether the application exceeds the five independent claim 
and twenty-five total claim threshold set forth Sec.  1.75(b)(1). See 
Sec.  1.75(b)(5). If the application contains more than five 
independent claims and twenty-five total claims (counting the rejoined 
claims) and the applicant did not file an examination support document 
in compliance with Sec.  1.265 before the issuance of a first Office 
action on the merits in the application, then the applicant must amend 
the application to contain no more than five independent claims and no 
more than twenty-five total claims. See Sec.  1.75(b)(1). Therefore, 
applicants cannot rely upon a provisional requirement for restriction 
to avoid submitting an examination support document before the issuance 
of the first Office action on the merits in the application.
    Furthermore, upon the allowance of a claim that is generic to all 
of the claimed species (either in the initial application or any 
continuing application), the application is no longer subject to a 
requirement to comply with the requirement of unity of invention under 
PCT Rule 13 or a requirement for restriction under 35 U.S.C. 121. In 
such a situation, if applicant had filed a ``divisional'' application 
to the non-elected species following the provisional restriction in the 
prior-filed application, that ``divisional'' application would no 
longer be proper under Sec. Sec.  1.78(a)(2) and 1.78(d)(1)(ii). This 
is because the ``divisional'' application would not meet the conditions 
set forth in Sec. Sec.  1.78(a)(2) and 1.78(d)(1)(ii). If applicant 
wishes to maintain the application, then applicant must delete or 
correct the benefit claim to indicate that the application is a 
continuation application, provided the requirements set forth in Sec.  
1.78(d)(1)(i) can be

[[Page 46728]]

satisfied. In such case, the Office will treat the application as one 
of the two continuation applications of the prior-filed application 
permitted under Sec.  1.78(d)(1)(i). But, if the prior-filed 
application already has its benefit claimed in two other nonprovisional 
applications, applicant must delete the benefit claim in the 
application. See Sec.  1.78(d)(1)(i). Therefore, applicant is cautioned 
not file a divisional application drawn to a non-elected species if a 
generic claim is pending in the initial application or any continuing 
application of the initial application and could be found allowable.
    When an application subject to an election of species is allowed 
with no claim that is generic to all of the claimed species being found 
to have been allowable, the applicant will be notified that the Office 
considers the requirement that the application be restricted to a 
single species to be final. At that point, the applicant may cancel the 
claims to the non-elected species and the generic claim in the prior-
filed application and file a divisional application in accordance with 
Sec.  1.78(d)(1)(ii) to the non-elected species. However, if the 
applicant later files a continuing application of the initial 
application or the divisional application presenting one or more 
generic claims in such later application, the Office will consider the 
requirement that the initial application be restricted to a single 
species to no longer be final. Should that occur, the ``divisional'' 
application directed to the non-elected species would not be proper 
under Sec. Sec.  1.78(a)(2) and 1.78(d)(1)(ii) for the reasons 
explained above. Thus, applicants should conclude prosecution, 
including exhaustion of any available appeals, as to the generic claim 
before ever filing a divisional application to a non-elected species. 
In other words, applicants cannot rely upon a requirement that an 
application containing a generic claim will be restricted to a single 
species to permit filing one or more divisional applications until the 
applicant has concluded prosecution with respect to any generic claims.
    Under the Office's rejoinder practice, an applicant may request 
rejoinder of claims to a non-elected invention that depend from or 
otherwise require all the limitations of an allowable claim. See MPEP 
Sec.  821.04 et seq. This ``rejoinder'' practice was developed in light 
of the Federal Circuit's decisions in In re Ochiai, 71 F.3d 1565, 37 
U.S.P.Q.2d 1127 (Fed. Cir. 1995), and In re Brouwer, 77 F.3d 422, 37 
U.S.P.Q.2d 1663 (Fed. Cir. 1996), and the enactment of 35 U.S.C. 103(b) 
in The Biotechnology Process Act of 1995 (Pub. L. 104-41, 109 Stat. 351 
(1995)). See Guidance on Treatment of Product and Process Claims in 
light of In re Ochiai, In re Brouwer, and 35 U.S.C. 103(b), 1184 Off. 
Gaz. Pat. Office 86 (Mar. 26, 1996). Applicants may retain claims to a 
non-elected invention in an application for possible rejoinder in the 
event of the allowance of a claim to the elected invention. However, as 
discussed previously, the Office will count rejoined claims towards the 
five independent claim and twenty-five total claim threshold in Sec.  
1.75(b)(1). See Sec.  1.75(b)(5). If applicant cancels all of the 
claims directed to a non-elected invention before rejoinder occurs and 
files a divisional application, the restriction requirement will not be 
withdrawn and the non-elected process claims that are now canceled will 
not be rejoined. This will preserve applicant's rights under 35 U.S.C. 
121 and Sec.  1.78(d)(1)(ii). See MPEP Sec.  821.04(b).
    Section 1.75(c) is amended to provide for multiple dependent claims 
only. Dependent claims are now provided for in Sec.  1.75(b). Section 
1.75(c) further provides that multiple dependent claims and claims that 
depend from a multiple dependent claim will be considered to be that 
number of claims to which direct reference is made in the multiple 
dependent claim for purposes of Sec.  1.75(b) (as well as Sec.  1.16 or 
1.492).
    The changes to Sec.  1.75 are applicable to any application 
(including any reissue application) filed under 35 U.S.C. 111(a) on or 
after November 1, 2007, and to any nonprovisional application entering 
the national stage after compliance with 35 U.S.C. 371 on or after 
November 1, 2007, as well as to any application (including any reissue 
application) in which a first Office action on the merits (Sec.  1.104) 
was not mailed before November 1, 2007. The Office will provide an 
applicant who filed a nonprovisional application under 35 U.S.C. 111(a) 
before November 1, 2007, or a nonprovisional application that entered 
the national stage after compliance with 35 U.S.C. 371 before November 
1, 2007, and who would be affected by the changes in the final rule, 
with an opportunity to submit: (1) An examination support document 
under Sec.  1.265; (2) a new set of claims such that the application 
contains five or fewer independent claims and twenty-five or fewer 
total claims; or (3) a suggested restriction requirement under Sec.  
1.142(c). Specifically, the Office will issue a notice setting a two-
month time period that is extendable under Sec.  1.136(a) or (b) within 
which the applicant must exercise one of these options in order to 
avoid abandonment of the application. The Office, however, may combine 
such a notice with a requirement for restriction, in which case the 
applicant must make an election responsive to the restriction 
requirement and, if there are more than five independent claims or more 
than twenty-five total claims drawn to the elected invention, the 
applicant must also: (1) File an examination support document in 
compliance with Sec.  1.265; or (2) amend the application such that it 
contains five or fewer independent claims and twenty-five or fewer 
total claims drawn to the elected invention. Thus, if such a notice is 
combined with a requirement for restriction, the applicant does not 
have the option of replying to such notice with a suggested restriction 
requirement under Sec.  1.142(c).
    With respect to the application of the changes to Sec.  1.75 in 
this final rule to a reissue application, an examination support 
document under Sec.  1.265 will not be required pursuant to Sec.  
1.75(b) in a reissue application if the reissue application does not 
seek to change the claims in the patent being reissued. A change in the 
claims in the patent being reissued is sought either by an amendment to 
or addition of a claim or claims, or by an amendment to the 
specification which changes a claim or claims.
    Section 1.76 (application data sheet): Section 1.76(b)(5) is 
amended to refer to Sec. Sec.  1.78(b)(3) and (d)(3) for consistency 
with the changes to Sec.  1.78. Section 1.76(b)(5) is also amended to 
clarify that the relationship of the applications is not required for a 
benefit claim under 35 U.S.C. 119(e) and to delete ``the status 
(including patent number if available)''. Such information is not 
necessary for claiming the benefit of a prior-filed application under 
35 U.S.C. 119(e), 120, 121, or 365(c).
    Section 1.78 (claiming benefit of earlier filing date and cross-
references to other applications): Section 1.78 is reorganized as 
follows: (1) Sec.  1.78(a) defines ``continuing application'', 
``continuation application'', ``divisional application'', and 
``continuation-in-part application''; (2) Sec.  1.78(b) contains 
provisions relating to claims under 35 U.S.C. 119(e) for the benefit of 
a prior-filed provisional application; (3) Sec.  1.78(c) contains 
provisions relating to delayed claims under 35 U.S.C. 119(e) for the 
benefit of a prior-filed provisional application; (4) Sec.  1.78(d) 
contains provisions relating to claims under 35 U.S.C. 120, 121, or 
365(c) for the benefit of a prior-filed nonprovisional or international 
application; (5) Sec.  1.78(e) contains provisions relating to delayed 
claims under 35 U.S.C. 120, 121, or 365(c) for

[[Page 46729]]

the benefit of a prior-filed nonprovisional or international 
application; (6) Sec.  1.78(f) contains provisions relating to 
applications naming at least one inventor in common and containing 
patentably indistinct claims; (7) Sec.  1.78(g) contains provisions 
relating to applications or patents under reexamination naming 
different inventors and containing patentably indistinct claims; (8) 
Sec.  1.78(h) contains provisions pertaining to the treatment of 
parties to a joint research agreement under the CREATE Act; and Sec.  
1.78(i) provides that the time periods set forth in Sec.  1.78 are not 
extendable.
    Section 1.78(a)(1) defines a ``continuing application'' as a 
nonprovisional application or international application designating the 
United States of America that claims the benefit under 35 U.S.C. 120, 
121, or 365(c) of a prior-filed nonprovisional application or 
international application designating the United States of America. 
Section 1.78(a)(1) provides that an application that does not claim the 
benefit under 35 U.S.C. 120, 121, or 365(c) of a prior-filed 
application, is not a continuing application even if the application 
claims the benefit under 35 U.S.C. 119(e) of a provisional application, 
claims priority under 35 U.S.C. 119(a)-(d) or 365(b) to a foreign 
application, or claims priority under 35 U.S.C. 365(a) or (b) to an 
international application designating at least one country other than 
the United States of America. A continuing application must be a 
continuation application, a divisional application, or a continuation-
in-part application. See MPEP Sec.  201.11 (``To specify the 
relationship between the applications, applicant must specify whether 
the application is a continuation, divisional, or continuation-in-part 
of the prior application. Note that the terms are exclusive. An 
application cannot be, for example, both a continuation and a 
divisional or a continuation and a continuation-in-part of the same 
application.'').
    Section 1.78(a)(2) defines a ``divisional application'' as a 
continuing application that discloses and claims only an invention or 
inventions that were disclosed and claimed in a prior-filed 
application, but were subject to a requirement to comply with the 
requirement of unity of invention under PCT Rule 13 or a requirement 
for restriction under 35 U.S.C. 121 in the prior-filed application, and 
were not elected for examination and were not examined in any prior-
filed application. This definition is more precise than the definition 
of ``divisional application'' currently found in MPEP Sec.  201.06. 
MPEP Sec.  201.06 defines a divisional application as an application 
for an independent and distinct invention, which discloses and claims 
only subject matter that was disclosed in the prior-filed 
nonprovisional application. Section 1.78(a)(2), however, limits the 
definition of ``divisional application'' to an application that claims 
only an invention or inventions that were subject to a requirement to 
comply with the requirement of unity of invention under PCT Rule 13 or 
a requirement for restriction under 35 U.S.C. 121 in the prior-filed 
application and not elected for examination and not examined in any 
prior-filed application. See 35 U.S.C. 121 (``[i]f two or more 
independent and distinct inventions are claimed in one application, the 
Director may require the application to be restricted to one of the 
inventions [and i]f the other invention is made the subject of a 
divisional application which complies with the requirements of [35 
U.S.C.] 120 * * *.''). The Office will revise the definition of 
divisional application in MPEP Sec.  201.06 in the next revision of the 
MPEP. An application that claims the benefit of a prior-filed 
divisional application as defined in Sec.  1.78(a)(2), and claims the 
same patentable invention as the prior-filed divisional application, 
would not be a divisional application as defined by Sec.  1.78(a)(2). 
Instead, such an application would be a continuation application.
    Section 1.78(a)(3) defines a ``continuation application'' as a 
continuing application as defined in Sec.  1.78(a)(1) that discloses 
and claims only an invention or inventions that were disclosed in the 
prior-filed application. See MPEP Sec.  201.07 (defines a continuation 
application as an application that discloses (or discloses and claims) 
only subject matter that was disclosed in the prior-filed 
nonprovisional application).
    Section 1.78(a)(4) defines a ``continuation-in-part application'' 
as a continuing application as defined in Sec.  1.78(a)(1) that 
discloses subject matter that was not disclosed in the prior-filed 
application. See MPEP Sec.  201.08 (a continuation-in-part repeats some 
substantial portion or all of the earlier nonprovisional application 
and adds matter not disclosed in the prior-filed nonprovisional 
application).
    Section 1.78(b) addresses claims under 35 U.S.C. 119(e) for the 
benefit of a prior-filed provisional application. Under 35 U.S.C. 
119(e)(1), a provisional application must disclose the invention 
claimed in at least one claim of the later-filed application in the 
manner provided by 35 U.S.C. 112, ] 1, for the later-filed application 
to receive the benefit of the filing date of the provisional 
application. See New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 
F.3d 1290, 1294, 63 U.S.P.Q.2d 1843, 1846 (Fed. Cir. 2002) (for a 
nonprovisional application to actually receive the benefit of the 
filing date of the provisional application, ``the specification of the 
provisional [application] must `contain a written description of the 
invention and the manner and process of making and using it, in such 
full, clear, concise, and exact terms,' 35 U.S.C. 112 ] 1, to enable an 
ordinarily skilled artisan to practice the invention claimed in the 
nonprovisional application''). Section 1.78(b), however, does not also 
state (as did former Sec.  1.78(a)(4)) that the provisional application 
must disclose the invention claimed in at least one claim of the later-
filed application in the manner provided by 35 U.S.C. 112, ] 1, because 
it is not necessary for the rules of practice to restate provisions of 
a statute.
    Section 1.78(b)(1) provides that the nonprovisional application or 
international application designating the United States of America must 
be filed not later than twelve months after the date on which the 
provisional application was filed, and that this twelve-month period is 
subject to 35 U.S.C. 21(b) and Sec.  1.7(a). 35 U.S.C. 21(b) and Sec.  
1.7(a) provide that when the day, or the last day, for taking any 
action (e.g., filing a nonprovisional application within twelve months 
of the date on which the provisional application was filed) or paying 
any fee in the Office falls on Saturday, Sunday, or a Federal holiday 
within the District of Columbia, the action may be taken, or fee paid, 
on the next succeeding secular or business day. Section 1.78(b) 
otherwise contains the provisions of former Sec.  1.78(a)(4) and 
(a)(5).
    Sections 1.78(b)(2) through (b)(5) contain the provisions of former 
1.78(a)(4) and (a)(5). Section 1.78(c) contains provisions relating to 
delayed claims under 35 U.S.C. 119(e) for benefit of prior-filed 
provisional applications. Section 1.78(c) contains the provisions of 
former Sec.  1.78(a)(6).
    Section 1.78(d) contains provisions relating to claims under 35 
U.S.C. 120, 121, or 365(c) for the benefit of a prior-filed 
nonprovisional or international application.
    Section 1.78(d)(1) provides conditions under which an application 
may claim the benefit under 35 U.S.C. 120, 121, or 365(c) and Sec.  
1.78 of a prior-filed nonprovisional application or international 
application designating the United States of America. Section 
1.78(d)(1) also provides that the Office

[[Page 46730]]

will refuse to enter, or will delete if present, any specific reference 
to a prior-filed application that is not permitted by Sec.  1.78(d)(1). 
If the claim for the benefit of a prior-filed nonprovisional 
application or international application designating the United States 
of America is not permitted by Sec.  1.78(d)(1), the Office will refuse 
benefit. Section 1.78(d) also provides that the entry of or failure to 
delete a specific reference to a prior-filed application that is not 
permitted by Sec.  1.78(d)(1) does not constitute a waiver of the 
provisions of Sec.  1.78(d)(1). The grant of a petition under Sec.  
1.78(d)(1)(vi) or waiver of a requirement of Sec.  1.78(d)(1) would be 
only by an explicit decision by an official who has been delegated the 
authority to decide such a petition or waiver. It would not occur by 
implication due to the entry of or failure to delete a specific 
reference to a prior-filed application that is not permitted by Sec.  
1.78(d)(1).
    These provisions of Sec.  1.78(d)(1) were included in the proposed 
changes to Sec.  1.78(d)(3). See Changes to Practice for Continuing 
Applications, Requests for Continued Examination Practice, and 
Applications Containing Patentably Indistinct Claims, 71 FR at 54, 60, 
1302 Off. Gaz. Pat. Office at 1323, 1328.
    Section 1.78(d)(1)(i) provides for continuation applications or 
continuation-in-part applications that do not claim the benefit of a 
divisional application (either directly or indirectly). Section 
1.78(d)(1)(i) permits such a continuation application or continuation-
in-part application of a prior-filed nonprovisional application or 
international application designating the United States of America if: 
(1) The application is a continuation application as defined in Sec.  
1.78(a)(3) or a continuation-in-part application as defined in Sec.  
1.78(a)(4) that claims the benefit under 35 U.S.C. 120, 121, or 365(c) 
of no more than two prior-filed applications; and (2) any application 
whose benefit is claimed under 35 U.S.C. 120, 121, or 365(c) in such 
nonprovisional application has its benefit claimed in no more than one 
other nonprovisional application. This does not include any 
nonprovisional application that satisfies the conditions set forth in 
Sec.  1.78(d)(1)(ii), (d)(1)(iii) or (d)(1)(vi).
    Section 1.78(d)(1)(i) permits an applicant to continue prosecution 
of an application via two continuation applications (in parallel or 
serially), a continuation application and a continuation-in-part 
application (in parallel or serially), or two continuation-in-part 
applications (in parallel or serially). Applicants choosing to file 
applications (whether continuing or non-continuing) in parallel are 
reminded that Sec.  1.75(b)(4) provides that, if certain conditions are 
met, the Office will treat each such application as having the total 
number of claims present in all of such applications for purposes of 
determining whether an examination support document is required by 
Sec.  1.75(b). See also Sec.  1.78(f) concerning additional provisions 
that are applicable if there are multiple applications that have the 
same claimed filing or priority date, substantial overlapping 
disclosure, a common inventor, and common assignee.
    If an application is identified as a continuation-in-part 
application, however, Sec.  1.78(d)(3) provides that the applicant must 
identify the claim or claims in the continuation-in-part application 
for which the subject matter is disclosed in the manner provided by 35 
U.S.C. 112, ] 1, in the prior-filed application. See discussion of 
Sec.  1.78(d)(3). Any claims in the continuation-in-part application 
that are not identified under Sec.  1.78(d)(3) as supported by the 
prior-filed application will be subject to prior art based on the 
actual filing date of the continuation-in-part application.
    For a continuation-in-part application that contains one or more 
claims for which the subject matter is not disclosed in the manner 
provided by 35 U.S.C. 112, ] 1, in the prior-filed application, Sec.  
1.78(d)(1)(i) will permit an applicant to continue prosecution of the 
claims that are directed solely to subject matter added in such 
continuation-in-part application via two continuation applications (or 
a continuation application and a continuation-in-part application, or 
two continuation-in-part applications). However, the ``additional'' 
continuation or continuation-in-part applications cannot claim the 
benefit of the prior-filed application relative to the first 
continuation-in-part application. The subject matter of at least one 
claim of a later-filed application must be disclosed in the prior-filed 
application in the manner provided by 35 U.S.C. 112, ] 1, for the 
later-filed application to actually receive the benefit of the filing 
date of the prior-filed application under 35 U.S.C. 120. See 
Studiengesellschaft Kohle m.b.H. v. Shell Oil Co., 112 F.3d 1561, 1564-
65, 42 U.S.P.Q.2d 1674, 1677-78 (Fed. Cir. 1997). In addition, the term 
of any resulting patent will be measured under 35 U.S.C. 154(a)(2) from 
the filing date of the prior-filed application, even if the later-filed 
application never receives any benefit from the prior-filed 
application. See Abbott Labs. v. Novopharm Ltd., 104 F.3d 1305, 1309, 
41 U.S.P.Q.2d 1535, 1537 (Fed. Cir. 1997) (rejecting patentee's 
argument that it should not be bound by the filing date of the prior-
filed application because the later-filed application never received 
any actual benefit from the prior-filed application). Thus, the Office 
will not require that such ``additional'' continuation or continuation-
in-part applications contain a showing that all of the claims are 
directed solely to subject matter added in the first continuation-in-
part application. Rather, Sec.  1.78(d)(1)(i) permits the 
``additional'' continuation or continuation-in-part application to 
claim the benefit of the first continuation-in-part application, but 
does not permit the ``additional'' continuation or continuation-in-part 
application to also claim the benefit of the prior-filed initial 
application (the prior-filed application relative to the first 
continuation-in-part application). For example, consider an applicant 
who files: (1) An initial application ``A''; (2) a first continuation-
in-part application ``B'' that claims the benefit of application ``A''; 
(3) a second continuation (or continuation-in-part) application ``C'' 
that claims the benefit of applications ``B'' and ``A''; and (4) an 
additional continuation (or continuation-in-part) application ``D'' 
that claims the benefit of applications ``C'' and ``B''. Under Sec.  
1.78(d)(1)(i), application ``D'' may claim the benefit of application 
``C'' and continuation-in-part application ``B'', but may not claim any 
benefit of application ``A'' (except as permitted under Sec.  
1.78(d)(1)(vi)).
    Applicants are permitted to file two continuation or continuation-
in-part applications (Sec.  1.78(d)(1)) and one request for continued 
examination (Sec.  1.114) without any justification. The provisions of 
Sec.  1.78(d)(1) are independent of the provisions of Sec.  1.114. 
Therefore, the filing of a request for continued examination does not 
preclude an applicant from filing two continuation or continuation-in-
part applications. In addition, an applicant may not agree to forgo a 
continuation application (or continuation-in-part application) to 
obtain a second or third request for continued examination, nor can an 
applicant agree to forgo a request for continued examination in 
exchange for a third continuation or continuation-in-part application. 
For example, an applicant cannot file a second request for continued 
examination without any justification instead of filing one of the two 
permitted continuation applications; and an applicant cannot file three 
continuation applications

[[Page 46731]]

instead of filing a request for continued examination. Of course, 
applicant may seek by petition a third or subsequent continuation or 
continuation-in-part application or a second or subsequent request for 
continued examination.
    The Office, however, is implementing an optional streamlined 
continuation application procedure under which an applicant may request 
to have a continuation application filed on or after November 1, 2007, 
placed on an examiner's amended (Regular Amended) docket. The examiner 
will normally pick up for action a continuation application that has 
been placed on the examiner's amended (Regular Amended) docket faster 
(e.g., within a few months from the date the application is docketed) 
than an application placed on the examiner's new continuing application 
(New Special) docket. The following conditions must be met for the 
continuation application to be placed on an examiner's amended (Regular 
Amended) docket rather than on the new continuing application (New 
Special) docket: (1) The application must disclose and claim only an 
invention or inventions that were disclosed and claimed in the prior-
filed application; (2) the applicant must agree that any election in 
response to a requirement to comply with the requirement of unity of 
invention under PCT Rule 13 or a requirement for restriction under 35 
U.S.C. 121, including an election of species requirement, in the prior-
filed application carries over to the continuation application; (3) the 
prior-filed application must be under a final Office action (Sec.  
1.113) or under appeal at the time of filing the continuation 
application; (4) the prior-filed application must be expressly 
abandoned upon filing of the continuation application, with a letter of 
express abandonment under Sec.  1.138 being concurrently filed in the 
prior-filed application; and (5) applicant must request that the 
continuation application be placed on an examiner's amended (Regular 
Amended) docket. This procedure is not applicable to design 
applications because the continued prosecution application procedures 
of Sec.  1.53(d) currently provide design applicants with an optional 
streamlined continuation application procedure.
    The optional streamlined continuation application procedure, 
however, does require that the applicant provide a continuation 
application filed under 35 U.S.C. 111(a) and Sec.  1.53(b) (and not a 
request for continued examination under 35 U.S.C. 132(b) and Sec.  
1.114 or a continued prosecution application under Sec.  1.53(d)). 
Thus, the applicant must file a continuation application that meets the 
conditions set forth in 35 U.S.C. 111(a) and Sec.  1.53(b) to be 
accorded a filing date. The continuation application must also be 
complete under Sec.  1.51(b) or completed under Sec.  1.53(f). The 
Office will not docket an application for examination until the 
application is complete (Sec. Sec.  1.51(b) and 1.53(f)) and in 
condition for publication (Sec.  1.211). See Sec.  1.53(h). Thus, any 
delay in submitting the filing fee and oath or declaration (or copy of 
the oath or declaration from the prior-filed application under Sec.  
1.63(d)) will delay the docketing of a continuation application even if 
the applicant has requested that the continuation application be given 
streamlined docketing.
    This optional streamlined continuation application procedure 
concerns only the placement of the continuation application on an 
examiner's amended (Regular Amended) docket. The continuation 
application is otherwise treated as a new application for patent. For 
example, (1) the application filing fees including the basic filing 
fee, search and examination fees, and any required excess claims fees 
(and not the request for continued examination fee set forth in Sec.  
1.17(e)) are required; (2) the continuation application will be 
assigned a new application number; and (3) the continuation application 
is subject to the patent term provisions of 35 U.S.C. 154(b) and Sec.  
1.702 et seq. as a new continuation application (and not a request for 
continued examination in the prior-filed application).
    Section 1.78(d)(1)(ii) provides for divisional applications of an 
application for the claims to a non-elected invention that has not been 
examined if the application was subject to a requirement to comply with 
the requirement of unity of invention under PCT Rule 13 or a 
requirement for restriction under 35 U.S.C. 121. The divisional 
application need not be filed during the pendency of the application 
subject to a requirement for restriction, as long as the copendency 
requirement of 35 U.S.C. 120 is met. This final rule also permits 
applicant to file two continuation applications of a divisional 
application plus a request for continued examination in the divisional 
application family, without any justification. See Sec. Sec.  
1.78(d)(1)(iii) and 1.114(f).
    Specifically, Sec.  1.78(d)(1)(ii) permits a divisional application 
of a prior-filed nonprovisional application or international 
application designating the United States of America under the 
following conditions. First, the divisional application must be a 
divisional application as defined in Sec.  1.78(a)(2) that claims the 
benefit under 35 U.S.C. 120, 121, or 365(c) of a prior-filed 
application that was subject to a requirement to comply with the 
requirement of unity of invention under PCT Rule 13 or a requirement 
for restriction under 35 U.S.C. 121. Second, the divisional application 
must contain only claims directed to an invention or inventions that 
were identified in the requirement to comply with the requirement of 
unity of invention or requirement for restriction but were not elected 
for examination and were not examined in the prior-filed application or 
in any other nonprovisional application. The ``not elected for 
examination and were not examined in any other nonprovisional 
application'' requirement does not apply to any continuation 
application that claims the benefit under 35 U.S.C. 120, 121, or 365(c) 
of the divisional application and satisfies the conditions set forth in 
Sec.  1.78(d)(1)(iii) or (d)(1)(vi).
    Section 1.78(d)(1)(ii)(A) permits an applicant to obtain 
examination of claims that were withdrawn from consideration in the 
prior-filed application due to a requirement to comply with the 
requirement of unity of invention under PCT Rule 13 or a requirement 
for restriction under 35 U.S.C. 121. Thus, Sec.  1.78(d)(1)(ii)(A) 
permits a divisional application filed as a result of a requirement to 
comply with the requirement of unity of invention under PCT Rule 13 or 
requirement for restriction under 35 U.S.C. 121 in the prior-filed 
application. Section 1.78(d)(1)(ii)(A), however, does not permit a 
divisional application not filed as a result of such a requirement in 
the prior-filed application. Thus, Sec.  1.78(d)(1)(ii)(A) permits so-
called ``involuntary'' divisional applications but does not permit so-
called ``voluntary'' divisional applications.
    Section 1.78(d)(1)(ii)(B) does not permit the filing of a set of 
parallel divisional applications containing claims to the same 
invention. Applicant, however, may serially prosecute up to two 
continuation applications that contain claims to the same invention as 
is claimed in a prior-filed divisional application if the continuation 
application satisfies the conditions of Sec.  1.78(d)(1)(iii).
    As discussed previously, applicants cannot rely upon a requirement 
for restriction including an election of species to file a divisional 
application in situations where: (1) The applicant traverses the 
requirement for restriction;

[[Page 46732]]

(2) the requirement for restriction may be conditional, such as a 
requirement for election of species in an application that contains a 
claim that is generic to all of the claimed species (see MPEP section 
809); and (3) the claims to the non-elected invention may be rejoined 
at the request of the applicant (see MPEP Sec.  821.04 et seq.). See 
the discussion of Sec.  1.75(b)(5). This is because when the 
requirement for restriction is withdrawn in the prior-filed 
application, any divisional application that has been filed as the 
result of the restriction requirement of the prior-filed application 
will not be proper under Sec. Sec.  1.78(a)(2) and 1.78(d)(1)(ii). 
Applicant is not permitted to file a divisional application of a prior-
filed application that is no longer subject to a restriction 
requirement. Under Sec. Sec.  1.78(a)(2) and 1.78(d)(1)(ii), the prior-
filed application to which a divisional application claims the benefit 
must be subject to a requirement to comply with the requirement of 
unity of invention under PCT Rule 13 or a requirement for restriction 
under 35 U.S.C. 121. Sections 1.78(a)(2) and 1.78(d)(1)(ii) also 
require a divisional application to contain only claims directed to a 
non-elected invention that has not been examined.
    For an application that contains a generic claim in which a 
requirement for an election of species has been made, applicants should 
conclude prosecution of the generic claim in the initial application 
and its continuation or continuation-in-part applications, including 
exhaustion of any available appeals, before even filing a divisional 
application to a non-elected species. If applicant no longer wants to 
pursue the generic claim, applicant may file a divisional application 
directed to a non-elected species. If applicant files a divisional 
application directed to a non-elected species, applicant must: (1) 
Cancel the claims to the non-elected species and the generic claim in 
the prior-filed application before a rejoinder or reinstatement occurs; 
(2) not present the non-elected claims and the generic claim in any 
continuation or continuation-in-part application of the initial 
application; and (3) not present the generic claim in the divisional 
application or any continuation application of the divisional 
application.
    Under the Office's rejoinder practice, an applicant may request 
rejoinder of claims to a non-elected invention that depend from or 
otherwise require all the limitations of an allowable claim. See MPEP 
Sec.  821.04 et seq. Applicants may retain claims to a non-elected 
invention in an application for possible rejoinder in the event of the 
allowance of a claim to the elected invention. If applicant cancels all 
of the claims directed to a non-elected invention before rejoinder 
occurs and files a divisional application, the restriction requirement 
will not be withdrawn and the non-elected claims that are now canceled 
will not be rejoined. This will preserve applicant's rights under 35 
U.S.C. 121 and Sec.  1.78(d)(1)(ii). See MPEP Sec.  821.04(b).
    Section 1.78(d)(1)(iii) provides for continuation applications that 
claim the benefit of a divisional application (either directly or 
indirectly). Section 1.78(d)(1)(iii) permits such a continuation 
application of a prior-filed nonprovisional application or 
international application designating the United States of America if: 
(1) The application is a continuation application as defined in Sec.  
1.78(a)(3) that claims the benefit under 35 U.S.C. 120, 121, or 365(c) 
of a divisional application that satisfies the conditions set forth in 
Sec.  1.78(d)(1)(ii); (2) the application discloses and claims only an 
invention or inventions that were disclosed and claimed in the 
divisional application; (3) the application claims the benefit of only 
the divisional application, any application to which such divisional 
application claims benefit under 35 U.S.C. 120, 121, or 365(c) in 
compliance with the conditions set forth in Sec.  1.78(d)(1)(ii), and 
no more than one intervening prior-filed nonprovisional application 
(i.e., only one continuation application of the divisional application 
filed between the divisional application and the second continuation 
application of the divisional application); and (4) no more than one 
other nonprovisional application claims the benefit of the divisional 
application. This does not include any other divisional application 
that satisfies the conditions set forth in Sec.  1.78(d)(1)(ii) or any 
nonprovisional application that claims the benefit of such divisional 
application and satisfies the conditions set forth in Sec.  
1.78(d)(1)(iii) or (d)(1)(vi). Section 1.78(d)(1)(iii) permits an 
applicant to continue prosecution of a divisional application via two 
continuation applications (in parallel or serially). The Office, 
however, will treat each application prosecuted in parallel as having 
the total number of claims present in all of such applications for 
purposes of determining whether an examination support document is 
required by Sec.  1.75(b) provided that the continuation application 
contains at least one claim that is patentably indistinct from at least 
one claim in the divisional application.
    Section 1.78(d)(1)(iii) does not permit a continuation-in-part of a 
divisional application. Section 1.78(d)(1)(iii) is designed to permit 
an applicant to complete prosecution with respect to an invention or 
inventions that were disclosed and claimed in a divisional application, 
and not to permit an applicant to seek patent protection for a new 
invention that merely bears some relationship to an invention or 
inventions that were disclosed and claimed in a divisional application. 
Section 1.78(d)(1)(i) provides a mechanism for applicants to seek 
patent protection for a new invention that is an improvement of an 
invention or inventions that were disclosed and claimed in an initial 
or continuing (including a divisional) application.
    The provisions of Sec. Sec.  1.78(d)(1)(i) through (d)(1)(iii) are 
illustrated with the following example: (1) There is an initial 
application ``A'' that is subject to a restriction requirement under 35 
U.S.C. 121 and Sec.  1.141 et seq.; (2) a continuation application 
``B'' of application ``A''; (3) a further continuation application 
``C'' which claims the benefit of continuation application ``B'' and 
initial application ``A''; (4) a divisional application ``D'' (based 
upon the restriction requirement under 35 U.S.C. 121 and Sec.  1.141 et 
seq. in application ``A''), which claims the benefit of continuation 
application ``C'', continuation application ``B'', and initial 
application ``A''; (5) a continuation application ``E'' of divisional 
application ``D'', which claims the benefit of divisional application 
``D'', continuation application ``C'', continuation application ``B'', 
and initial application ``A''; and (6) a further continuation 
application ``F'' of continuation application ``E'', which claims the 
benefit of continuation application ``E'', divisional application 
``D'', continuation application ``C'', continuation application ``B'', 
and initial application ``A''.
    Under Sec.  1.78(d)(1)(i), application ``C'' is either a 
continuation application under Sec.  1.78(a)(3) or a continuation-in-
part application under Sec.  1.78(a)(4) that claims the benefit of no 
more than two prior-filed applications ``B'' and ``A''. In addition, 
applications ``B'' and ``A'' whose benefit is claimed in application 
``C'' have their benefit claimed in no more than one other application 
(not including divisional application ``D'' or continuation 
applications ``E'' and ``F'' of the divisional application ``D''). That 
is, the benefit of application ``A'' is claimed in only one other 
application ``B'' (not including divisional application ``D'' or 
continuation

[[Page 46733]]

applications ``E'' and ``F'' of the divisional application ``D''), and 
the benefit of application ``B'' is claimed in only one other 
application ``C'' (not including divisional application ``D'' or 
continuation applications ``E'' and ``F'' of the divisional application 
``D'').
    Under Sec.  1.78(d)(1)(ii), nonprovisional application ``D'' is a 
divisional application under Sec.  1.78(a)(2) since it claims the 
benefit of prior-filed application ``A'' that was subject to a 
requirement to comply with the requirement of unity of invention under 
PCT Rule 13 or a requirement for restriction under 35 U.S.C. 121. 
Divisional application ``D'' may contain only claims directed to an 
invention identified in the requirement to comply with the requirement 
of unity of invention or requirement for restriction but were not 
elected for examination in prior-filed application ``A'' or in any 
other nonprovisional application (applications ``B and ``C''), except 
for a nonprovisional application (applications ``E'' and ``F'') that 
claims the benefit of divisional application ``D'' and satisfies the 
conditions of Sec.  1.78(d)(1)(iii). That is, divisional application 
``D'' may contain only claims directed to an invention or inventions 
that were identified in such requirement to comply with the requirement 
of unity of invention or requirement for restriction but were not 
elected for examination in any other application except for its 
continuation applications ``E'' and ``F''. Finally, the divisional 
application ``D'' claims the benefit of the prior-filed applications 
(applications ``A'', ``B'', and ``C'').
    Under Sec.  1.78(d)(1)(iii), nonprovisional application ``F'' is a 
continuation application under Sec.  1.78(a)(3) that claims the benefit 
of divisional application ``D''. Application ``D'' is a divisional 
application that satisfies the conditions set forth in Sec.  
1.78(d)(1)(ii). The nonprovisional application ``F'' may disclose and 
claim only an invention that was disclosed and claimed in divisional 
application ``D''. The nonprovisional application ``F'' claims the 
benefit of only divisional application ``D'', the applications to which 
divisional application ``D'' claims benefit in compliance with the 
conditions of Sec.  1.78(d)(1)(ii) (applications ``A'', ``B'', and 
``C''), and no more than one intervening prior-filed nonprovisional 
application (application ``E''). Divisional application ``D'' whose 
benefit is claimed in nonprovisional application ``E'' and in 
nonprovisional application ``F'' has its benefit claimed in no more 
than one other nonprovisional application. That is, with respect to 
application ``F'', divisional application ``D'' has its benefit claimed 
in no more than one other nonprovisional application (application 
``E''), and with respect to application ``E'', divisional application 
``D'' has its benefit claimed in no more than one other nonprovisional 
application (application ``F'').
    Section 1.78(d)(1)(iv) pertains to the situation in which an 
applicant files a bypass continuation (or continuation-in-part) 
application rather than paying the basic national fee (entering the 
national stage) in an international application in which a Demand for 
international preliminary examination (PCT Article 31) has not been 
filed, and the international application does not claim the benefit of 
any other nonprovisional application or international application 
designating the United States of America. Section 1.78(d)(1)(iv) 
provides that in this situation the applicant may file ``one more'' 
continuation application (or continuation-in-part application) without 
there being a requirement for a petition and showing under Sec.  
1.78(d)(1)(vi). A ``bypass'' continuation (or continuation-in-part) 
application is an application for patent filed under 35 U.S.C. 111(a) 
that claims the benefit of the filing date of an earlier international 
application designating the United States of America that did not enter 
the national stage under 35 U.S.C. 371. See H.R. Rep. No. 107-685, at 
222 (2002).
    Specifically, Sec.  1.78(d)(1)(iv) provides that a continuation 
application or continuation-in-part application is permitted if the 
following conditions are met: (1) The application claims benefit under 
35 U.S.C. 120 or 365(c) of a prior-filed international application 
designating the United States of America, and a Demand has not been 
filed and the basic national fee (Sec.  1.492(a)) has not been paid in 
the prior-filed international application and the prior-filed 
international application does not claim the benefit of any other 
nonprovisional application or international application designating the 
United States of America; (2) the application is a continuation 
application as defined in Sec.  1.78(a)(3) or a continuation-in-part 
application as defined in Sec.  1.78(a)(4) that claims the benefit 
under 35 U.S.C. 120, 121, or 365(c) of no more than three prior-filed 
applications; and (3) any application whose benefit is claimed under 35 
U.S.C. 120, 121, or 365(c) in such nonprovisional application has its 
benefit claimed in no more than two other nonprovisional applications. 
This does not include any nonprovisional application that satisfies the 
conditions set forth in Sec.  1.78(d)(1)(ii), (d)(1)(iii) or 
(d)(1)(vi).
    Section 1.78(d)(1)(v) pertains to the situation in which an 
applicant files a continuation (or continuation-in-part) application to 
correct informalities rather than completing an application for 
examination under Sec.  1.53 (i.e., the prior-filed application became 
abandoned due to the failure to timely reply to an Office notice issued 
under Sec.  1.53(f)). The prior-filed nonprovisional application, 
however, must be entitled to a filing date and have paid therein the 
basic filing fee within the pendency of the application. See Sec.  
1.78(d)(2). Section 1.78(d)(1)(v) provides that in this situation the 
applicant may file ``one more'' continuation application (or 
continuation-in-part application) without there being a requirement for 
a petition and showing under Sec.  1.78(d)(1)(vi). Specifically, Sec.  
1.78(d)(1)(v) provides that a continuation application or continuation-
in-part application is permitted if the following conditions are met: 
(1) The application claims benefit under 35 U.S.C. 120 or 365(c) of a 
prior-filed nonprovisional application filed under 35 U.S.C. 111(a), 
and the prior-filed nonprovisional application became abandoned due to 
the failure to timely reply to an Office notice issued under Sec.  
1.53(f) and does not claim the benefit of any other nonprovisional 
application or international application designating the United States 
of America; (2) the application is a continuation application as 
defined in Sec.  1.78(a)(3) or a continuation-in-part application as 
defined in Sec.  1.78(a)(4) that claims the benefit under 35 U.S.C. 
120, 121, or 365(c) of no more than three prior-filed applications; and 
(3) any application whose benefit is claimed under 35 U.S.C. 120, 121, 
or 365(c) in such nonprovisional application has its benefit claimed in 
no more than two other nonprovisional applications. This does not 
include any nonprovisional application that satisfies the conditions 
set forth in Sec.  1.78(d)(1)(ii), (d)(1)(iii) or (d)(1)(vi).
    Section 1.78(d)(1)(vi) provides that a continuing nonprovisional 
application that is filed to obtain consideration of an amendment, 
argument, or evidence that could not have been submitted during the 
prosecution of the prior-filed application, and does not satisfy the 
conditions set forth in Sec.  1.78(d)(1)(i), (ii), (iii), (iv) or (v), 
may claim the benefit under 35 U.S.C. 120, 121, or 365(c) of such 
prior-filed application. Under Sec.  1.78(d)(1)(vi), a petition must be 
filed in such nonprovisional application that is accompanied by the fee 
set forth in Sec.  1.17(f) and a showing

[[Page 46734]]

that the amendment, argument, or evidence sought to be entered could 
not have been submitted during the prosecution of the prior-filed 
application. This will permit an applicant to continue prosecution of 
an application via a continuing application to obtain consideration of 
an amendment, argument, or evidence that could not have been submitted 
during the prosecution of the prior-filed application. Section 
1.78(d)(1)(vi) sets forth the time period within which such a petition 
must be provided: (1) If the later-filed continuing application is an 
application filed under 35 U.S.C. 111(a), within four months from the 
actual filing date of the later-filed application; and (2) if the 
continuing application is a nonprovisional application which entered 
the national stage from an international application after compliance 
with 35 U.S.C. 371, within four months from the date on which the 
national stage commenced under 35 U.S.C. 371(b) or (f) in the 
international application.
    With respect to the application of the changes to Sec.  1.78 in 
this final rule to a reissue application, benefit claims under 35 
U.S.C. 120, 121, or 365(c) in the application for patent that is being 
reissued will not be taken into account in determining whether a 
continuing reissue application claiming the benefit under 35 U.S.C. 
120, 121, or 365(c) of the reissue application satisfies one or more of 
the conditions set forth in Sec. Sec.  1.78(d)(1)(i) through 
1.78(d)(1)(vi). However, an applicant may not use the reissue process 
to add to the original patent benefit claims under 35 U.S.C. 120, 121, 
or 365(c) that do not satisfy one or more of the conditions set forth 
in Sec. Sec.  1.78(d)(1)(i) through 1.78(d)(1)(vi), if the application 
for the original patent was filed on or after November 1, 2007.
    Section 1.78(d)(2) provides that each prior-filed application must 
name as an inventor at least one inventor named in the later-filed 
application. In addition, each prior-filed application must either be: 
(1) An international application entitled to a filing date in 
accordance with PCT Article 11 and designating the United States of 
America; or (2) a nonprovisional application under 35 U.S.C. 111(a) 
that is entitled to a filing date as set forth in Sec.  1.53(b) or 
Sec.  1.53(d) for which the basic filing fee set forth in Sec.  1.16 
has been paid within the pendency of the application (provisions from 
former Sec.  1.78(a)(1)).
    Section 1.78(d)(3) is amended to include the parenthetical ``(i.e., 
whether the later-filed application is a continuation, divisional, or 
continuation-in-part of the prior-filed nonprovisional application or 
international application)'' to clarify in the rules of practice what 
is meant by the requirement that an applicant identify the relationship 
of the applications. See MPEP Sec.  201.11.
    Section 1.78(d)(3) also provides that if an application is 
identified as a continuation-in-part application, the applicant must 
identify the claim or claims in the continuation-in-part application 
for which the subject matter is disclosed in the manner provided by 35 
U.S.C. 112, ] 1, in the prior-filed application. Any claim in the 
continuation-in-part application for which the subject matter is not 
identified as being disclosed in the manner provided by 35 U.S.C. 112, 
] 1, in the prior-filed application will be treated as entitled only to 
the actual filing date of the continuation-in-part application, and 
will be subject to prior art based on the actual filing date of the 
continuation-in-part application. As discussed previously, to avoid any 
unnecessary delay in the prosecution of the application, applicant 
should provide the identification before the examiner begins to conduct 
a prior art search. If the failure to identify the claims for which the 
subject matter is disclosed in the manner provided by 35 U.S.C. 112, ] 
1, in the prior-filed application causes the examiner to include a new 
prior art rejection in a second or subsequent Office action, the 
inclusion of the new prior art rejection will not preclude the Office 
action from being made final.
    This final rule eliminates from Sec.  1.78(d) the provision that 
the prior-filed application disclose the invention claimed in at least 
one claim of the later-filed application in the manner provided by 35 
U.S.C. 112, ] 1. For a later-filed application to receive the benefit 
of the filing date of a prior-filed application, 35 U.S.C. 120 requires 
that the prior-filed application must disclose the invention claimed in 
at least one claim of the later-filed application in the manner 
provided by 35 U.S.C. 112, ] 1. The Office, however, does not make a 
determination as to whether a prior-filed application discloses the 
invention claimed in a claim of the later-filed application in the 
manner provided by 35 U.S.C. 112, ] 1, unless that determination is 
necessary to determine the patentability of such claim. See MPEP Sec.  
201.08 (``Unless the filing date of the earlier nonprovisional 
application is actually needed * * *, there is no need for the Office 
to make a determination as to whether the requirement of 35 U.S.C. 120, 
that the earlier nonprovisional application discloses the invention of 
the second application in the manner provided by 35 U.S.C. 112, ] 1, is 
met and whether a substantial portion of all of the earlier 
nonprovisional application is repeated in the second application in a 
continuation-in-part situation. Accordingly, an alleged continuation-
in-part application should be permitted to claim the benefit of the 
filing date of an earlier nonprovisional application if the alleged 
continuation-in-part application complies with the * * * formal 
requirements of 35 U.S.C. 120.'').
    Section 1.78(d)(4) and (d)(5) contain the provisions of former 
Sec.  1.78(a)(2).
    Section 1.78(d)(6) provides that cross-references to applications 
for which a benefit is not claimed must be located in a paragraph 
separate from the paragraph containing the references to applications 
for which a benefit is claimed. Including cross-references to 
applications for which a benefit is not claimed in the same paragraph 
as the paragraph containing the references to applications for which a 
benefit is claimed may lead to the Office inadvertently scheduling the 
application for publication under 35 U.S.C. 122(b) and Sec.  1.211 et 
seq. on the basis of the cross-referenced applications having the 
earliest filing date.
    Section 1.78(e) contains provisions relating to delayed claims 
under 35 U.S.C. 120, 121, or 365(c) for benefit of prior-filed 
nonprovisional or international applications. Section 1.78(e) contains 
the provisions of former Sec.  1.78(a)(3).
    Section 1.78(f) contains provisions relating to applications and 
patents naming at least one inventor in common.
    Section 1.78(f)(1)(i) provides that the applicant in a 
nonprovisional application that has not been allowed (Sec.  1.311) must 
identify by application number (i.e., series code and serial number) 
and patent number (if applicable) each other pending or patented 
nonprovisional application, in a separate paper, for which the 
following conditions are met: (1) The application has a filing date 
that is the same as or within two months of the filing date of the 
other pending or patented application, taking into account any filing 
date for which a benefit is sought under title 35, United States Code; 
(2) the application names at least one inventor in common with the 
other pending or patented application; and (3) the application is owned 
by the same person, or subject to an obligation of assignment to the 
same person, as the other pending or patented application. This 
identification requirement would also apply to each identified 
application because the identifying application has

[[Page 46735]]

a filing date that is the same as or within two months of the filing 
date of the identified application and vice versa.
    The phrase ``taking into account any filing date for which a 
benefit is sought under title 35, United States Code'' in Sec.  
1.78(f)(1)(i)(A) means any filing date for which a benefit (or 
priority) is sought or claimed under 35 U.S.C. 111, 119, 120, 121, 363, 
or 365. Cf. 35 U.S.C. 122(b)(1)(A) (requires publication of patent 
applications ``promptly after the expiration of a period of 18 months 
from the earliest filing date for which a benefit is sought under this 
title'' (emphasis added), meaning eighteen months from the earliest 
filing date for which a benefit or priority is sought or claimed under 
35 U.S.C. 111, 119, 120, 121, 363, or 365). Thus, if an application 
claims the benefit of or priority to other applications, ``the filing 
date of [the application], taking into account any filing date for 
which a benefit is sought under title 35, United States Code,'' is the 
actual filing date of the application as well as the filing date of 
each application to which the application claims a benefit or priority. 
For example, if an application has a filing date of December 1, 2006, 
and claims the benefit of a nonprovisional application that was filed 
on June 1, 2004, and claims the priority of a foreign application that 
was filed on June 1, 2003, for purposes of Sec. Sec.  1.78(f)(1) and 
(f)(2) the filing date of the application ``taking into account any 
filing date for which a benefit is sought under title 35, United States 
Code,'' is December 1, 2006, June 1, 2004, and June 1, 2003.
    The phrase ``owned by the same person, or subject to an obligation 
of assignment to the same person'' in Sec.  1.78(f)(1)(i)(C) (and in 
Sec.  1.78(f)(2)(i)(C) and 1.78(f)(3)) has the same meaning as it does 
in 35 U.S.C. 103(c). See MPEP Sec.  706.02(l)(2) for a discussion of 
the definition of this phrase as it is used in 35 U.S.C. 103(c).
    The phrase ``has not been allowed'' in Sec.  1.78(f)(1)(i) (and in 
Sec.  1.78(f)(2)(ii) and (iii)) means a notice of allowance under Sec.  
1.311 has not been mailed in the application, or a notice of allowance 
under Sec.  1.311 has been mailed in the application but the 
application has been withdrawn from issue. Thus, the identification of 
such one or more other pending or patented nonprovisional applications 
under Sec.  1.78(f)(1)(i) is not required in an application in which a 
notice of allowance has been mailed, unless the application is 
withdrawn from issue.
    Section 1.78(f)(1)(ii) also provides that one or more other 
nonprovisional applications under Sec.  1.78(f)(1)(i) must be 
identified within the later of: (1) Four months from the actual filing 
date of a nonprovisional application filed under 35 U.S.C. 111(a); (2) 
four months from the date on which the national stage commenced under 
35 U.S.C. 371(b) or (f) in a nonprovisional application entering the 
national stage from an international application under 35 U.S.C. 371; 
or (3) two months from the mailing date of the initial filing receipt 
in the other nonprovisional application that is required to be 
identified under Sec.  1.78(f)(1)(i).
    Section 1.78(f)(2)(i) provides that a rebuttable presumption shall 
exist that a nonprovisional application contains at least one claim 
that is not patentably distinct from at least one of the claims in the 
one or more other pending or patented nonprovisional applications if: 
(1) The application has a filing date that is the same as the filing 
date of another pending application or patent, taking into account any 
filing date for which a benefit is sought; (2) the application names at 
least one inventor in common with the other pending application or 
patent; (3) the application is owned by the same person, or subject to 
an obligation of assignment to the same person, as the other pending 
application or patent; and (4) the application contains substantially 
overlapping disclosure as the other pending application or patent. 
Section 1.78(f)(2)(i) further provides that substantial overlapping 
disclosure exists if the other pending or patented nonprovisional 
application has written description support under 35 U.S.C. 112, ] 1, 
for at least one claim in the nonprovisional application.
    If these conditions exist, the applicant must under Sec.  
1.78(f)(2)(ii) in the nonprovisional application, unless the 
nonprovisional application has been allowed (Sec.  1.311), within the 
time period specified in Sec.  1.78(f)(2)(iii) either: (1) Rebut this 
presumption by explaining how the application contains only claims that 
are patentably distinct from the claims in each of such other pending 
applications or patents; or (2) submit a terminal disclaimer in 
accordance with Sec.  1.321(c). In addition, Sec.  1.78(f)(2)(ii)(B) 
provides that where one or more other pending nonprovisional 
applications containing patentably indistinct claims have been 
identified, the applicant must explain why there are two or more 
pending nonprovisional applications naming at least one inventor in 
common and owned by the same person, or subject to an obligation of 
assignment to the same person, which contain patentably indistinct 
claims. Unless applicant presents good and sufficient reasons for such 
multiple applications, the Office may require elimination of the 
patentably indistinct claims from all but one of the applications. See 
Sec.  1.78(f)(3).
    As discussed previously, for applications having a continuity 
relationship, the prior application must be pending at the time the 
continuing application is filed. See 35 U.S.C. 120 (requires that a 
continuing application be filed before the patenting or abandonment of 
or termination of proceedings on the prior application). An applicant 
is not required to provide an explanation under Sec.  1.78(f)(2)(ii)(B) 
for a continuation application or continuation-in-part application of a 
prior-filed application that has been allowed, provided that the prior-
filed application is not withdrawn from issue. Furthermore, where the 
other nonprovisional application containing patentably indistinct 
claims is allowed, the Office will not count the claims of the allowed 
application in determining whether the total number of claims present 
in all of the copending nonprovisional applications containing 
patentably indistinct claims exceeds the five independent claim and 
twenty-five total claim threshold under Sec.  1.75(b)(4). See the 
discussion of Sec.  1.75(b)(4). A terminal disclaimer in accordance 
with Sec.  1.321(c) will, however, be required in each nonprovisional 
application containing patentably indistinct claims to overcome any 
obviousness-type double patenting rejection.
    Under Sec.  1.78(f)(2)(iii), the actions specified in Sec.  
1.78(f)(2)(ii) (if required) must be taken within the later of: (1) 
Four months from the actual filing date of a nonprovisional application 
filed under 35 U.S.C. 111(a); (2) four months from the date on which 
the national stage commenced under 35 U.S.C. 371(b) or (f) in a 
nonprovisional application entering the national stage from an 
international application under 35 U.S.C. 371; (3) the date on which a 
claim that is not patentably distinct from a claim in one or more other 
pending or patented applications is presented; or (4) two months from 
the mailing date of the initial filing receipt in the one or more other 
pending or patented applications.
    The requirement under Sec.  1.78(f)(2)(ii) for taking one of the 
actions specified in Sec.  1.78(f)(2)(ii) does not apply to the 
applicant in the application in which a notice of allowance has been 
mailed, unless the application is withdrawn from issue (Sec.  1.313). 
For example, if an applicant filed a continuation application after a 
notice of allowance has been mailed in the prior-filed application, the 
applicant must either rebut the presumption under

[[Page 46736]]

Sec.  1.78(f)(2)(i) or submit a terminal disclaimer in accordance with 
Sec.  1.321(c) within the time period set forth in Sec.  
1.78(f)(2)(iii) in the continuation application. Under Sec.  
1.78(f)(2)(ii), the applicant, however, is not required to rebut the 
presumption or submit a terminal disclaimer in the allowed prior-filed 
application. Nevertheless, a terminal disclaimer in accordance with 
Sec.  1.321(c) will be required in each nonprovisional application 
containing patentably indistinct claims to overcome any obviousness-
type double patenting rejection.
    As discussed previously, when an applicant files multiple 
applications that are substantially the same, the applicant is 
responsible for assisting the Office in resolving potential double 
patenting situations, rather than taking no action until faced with a 
double patenting rejection. Thus, if an Office action must include a 
double patenting rejection (either statutory or obviousness-type double 
patenting), it is because the applicant has not met his or her 
responsibility to resolve the double patenting situation. Therefore, 
the inclusion of a new double patenting rejection in a second or 
subsequent Office action will not preclude the Office action from being 
made final.
    Section 1.78(f)(3) applies when there are two or more commonly 
owned (owned by the same person, or are subject to an obligation of 
assignment to the same person) nonprovisional applications containing 
patentably indistinct claims. Under Sec.  1.78(f)(3), unless applicant 
presents good and sufficient reasons for such multiple applications, 
the Office may require elimination of the patentably indistinct claims 
from all but one of the applications. Section 1.78(f)(3) contains 
provisions similar to former Sec.  1.78(b). The Office expects to apply 
this provision primarily in situations covered by Sec.  1.78(f)(2)(ii), 
under which applicants must explain why it is necessary that there are 
two or more pending nonprovisional applications naming at least one 
inventor in common and owned by the same person, or subject to an 
obligation of assignment to the same person, which contain patentably 
indistinct claims. The Office, however, may require that an applicant 
provide good and sufficient reason whenever there are two or more 
pending nonprovisional applications with such common ownership or 
assignment obligation and patentably indistinct claims, regardless of 
the relative filing dates of the applications. Section 1.78(f)(3) does 
not apply to the claims in a patent.
    The following are two examples where an applicant may have a good 
and sufficient reason under Sec.  1.78(f)(3) for there being two or 
more pending nonprovisional applications that contain patentably 
indistinct claims: (1) An applicant filed a continuation application 
after the mailing of a notice of allowance in the prior-filed 
application, but the allowance of the prior-filed application was 
subsequently withdrawn by the Office; or (2) an interference was 
declared in an application that contains both claims corresponding to 
the count and claims not corresponding to the count, the BPAI suggests 
that the claims not corresponding to the count be canceled from the 
application in interference and pursued in a separate application, and 
the applicant filed a continuation application to present the claims 
not corresponding to the count. These examples are merely illustrative 
and not exhaustive.
    Section 1.78(g) addresses applications or patents under 
reexamination that name different inventors and contain patentably 
indistinct claims. Section 1.78(g) contains the provisions of former 
Sec.  1.78(c), except that ``conflicting claims'' is changed to 
``patentably indistinct claims'' for clarity and for consistency with 
the language of Sec.  1.78(f).
    Section 1.78(h) covers the situation in which parties to a joint 
research agreement are treated (in essence) as a common owner for 
purposes of 35 U.S.C. 103 by virtue of the CREATE Act. Section 1.78(h) 
provides that if an application discloses or is amended to disclose the 
names of parties to a joint research agreement under 35 U.S.C. 
103(c)(2)(C), the parties to the joint research agreement are 
considered to be the same person for purposes of Sec.  1.78. The CREATE 
Act amended 35 U.S.C. 103(c) to provide that subject matter developed 
under a joint research agreement shall be treated as owned by the same 
person or subject to an obligation of assignment to the same person for 
purposes of determining obviousness if three conditions are met: (1) 
The claimed invention was made by or on behalf of parties to a joint 
research agreement that was in effect on or before the date the claimed 
invention was made; (2) the claimed invention was made as a result of 
activities undertaken within the scope of the joint research agreement; 
and (3) the application for patent for the claimed invention discloses 
or is amended to disclose the names of the parties to the joint 
research agreement. See Changes to Implement the Cooperative Research 
and Technology Enhancement Act of 2004, 70 FR 1818, 1818 (Jan. 11, 
2005), 1291 Off. Gaz. Pat. Office 58, 58-59 (Feb. 8, 2005) (final 
rule). Section 1.78(h) also provides that if the application is amended 
to disclose the names of parties to a joint research agreement, the 
applicant must identify the one or more other nonprovisional 
applications as required by Sec.  1.78(f)(1) with the amendment unless 
the applications have been identified within the four-month period 
specified in Sec.  1.78(f)(1).
    Section 1.78(i) provides that the time periods set forth in Sec.  
1.78 are not extendable.
    The changes to Sec.  1.78 (except Sec. Sec.  1.78(a) and 
1.78(d)(1)) are applicable to any nonprovisional application pending on 
or after November 1, 2007. The changes to Sec. Sec.  1.78(a) and 
1.78(d)(1) are applicable to any application filed on or after November 
1, 2007, or any application entering the national stage after 
compliance with 35 U.S.C. 371 on or after November 1, 2007. Except as 
otherwise indicated in this final rule, any application filed under 35 
U.S.C. 111(a) on or after November 1, 2007, or any application entering 
the national stage after compliance with 35 U.S.C. 371 on or after 
November 1, 2007, seeking to claim the benefit under 35 U.S.C. 120, 
121, or 365(c) and Sec.  1.78 of a prior-filed nonprovisional 
application or international application must either: (1) Meet the 
requirements specified in one of Sec. Sec.  1.78(d)(1)(i) through 
(d)(1)(v); or (2) include a grantable petition under Sec.  
1.78(d)(1)(vi).
    With respect to applications that claim the benefit under 35 U.S.C. 
120, 121, or 365(c) only of nonprovisional applications or 
international applications filed before August 21, 2007: An application 
is not required to meet the requirements set forth in Sec.  1.78(d)(1) 
if: (1) The application claims the benefit under 35 U.S.C. 120, 121, or 
365(c) only of prior-filed nonprovisional applications filed before 
August 21, 2007 or prior-filed applications entering the national stage 
after compliance with 35 U.S.C. 371 before August 21, 2007; and (2) 
there is no other application filed on or after the publication date of 
this final rule in the Federal Register that also claims the benefit 
under 35 U.S.C. 120, 121, or 365(c) of such prior-filed nonprovisional 
applications or international applications. This provision will provide 
applicants with ``one more'' continuation application or continuation-
in-part application of a second or subsequent continuing application 
(continuation application or continuation-in-part application) that was 
filed prior to the publication date of this final rule in the Federal 
Register

[[Page 46737]]

without a petition under Sec.  1.78(d)(1)(vi). Thus, an applicant may 
file a single continuation application or continuation-in-part 
application on or after November 1, 2007, without meeting the 
requirements specified in Sec.  1.78(d)(1)(i) through (d)(1)(v), or 
including a petition under Sec.  1.78(d)(1)(vi), even if the prior-
filed application was a second or subsequent continuation or 
continuation-in-part application. It should be noted that the purpose 
of this provision is to ensure that an applicant may file ``one more'' 
continuation application or continuation-in-part application of an 
application that was filed prior to the publication date of this final 
rule in the Federal Register without a petition and showing, and not to 
provide an ``extra'' continuation application or continuation-in-part 
application for applications filed prior to the publication date of 
this final rule in the Federal Register. If an application filed before 
the publication date of this final rule in the Federal Register is not 
a continuing application or is only the first continuing application, 
this provision will not entitle an applicant to file a third or 
subsequent continuation or continuation-in-part application without a 
petition under Sec.  1.78(d)(1)(vi) showing that the amendment, 
argument, or evidence sought to be entered could not have been 
submitted during the prosecution of the prior-filed application.
    Section 1.104 (nature of examination): The Office proposed a number 
of changes to Sec.  1.104 to implement the ``representative claims'' 
examination approach. See Changes to Practice for the Examination of 
Claims in Patent Applications, 71 FR at 64, 68, 1302 Off. Gaz. Pat. 
Office at 1131, 1332. The Office is not proceeding with the changes to 
Sec.  1.104 to implement the ``representative claims'' examination 
approach, but is revising Sec.  1.104 for consistency with current 
examination practices.
    Section 1.104(a)(1) is amended to add the phrase ``and other 
requirements'' to the phrase ``the examination shall be complete with 
respect both to compliance of the application or patent under 
reexamination with the applicable statutes and rules'' to address 
situations in which the requirement is based upon Office practice as 
set forth in the MPEP or in the case law. For example, the phrase 
``other requirements'' would address the situation in which a claim did 
not comply with the requirement in MPEP Sec.  608.01(m) that each claim 
be the object of a single sentence starting with ``I (or we) claim,'' 
``The invention claimed is,'' or the equivalent. See Fressola v. 
Manbeck, 36 U.S.P.Q.2d 1211, 1212 (D.D.C. 1995). In addition, in the 
event that there is a requirement for restriction including election of 
species, or both, the provision in Sec.  1.104(a)(1) for a ``thorough 
study [and] investigation of the available prior art relating to the 
subject matter of the claimed invention'' will continue to apply only 
with respect to the invention and species elected for examination on 
the merits. This provision of Sec.  1.104 does not apply with respect 
to an invention or species that has been withdrawn from consideration 
as a result of a requirement for restriction, including an election of 
species.
    Section 1.104(b) is also amended to delete the sentence 
``[h]owever, matters of form need not be raised by the examiner until a 
claim is found allowable.'' The Office would prefer that all matters of 
form be resolved at the earliest time during the patent examination 
process. Nevertheless, an Office action would not be considered 
improper simply because the Office action did not raise every 
applicable issue of form present in the application.
    Section 1.105 (requirements for information): Section 1.105(a)(1) 
is amended to provide that an applicant may be required to set forth 
where (by page and line or paragraph number) in the specification of 
the application, or any application the benefit of whose filing date is 
sought under title 35, United States Code, there is written description 
support for the invention as defined in the claims (whether in 
independent or dependent form), and of the manner and process of making 
and using it, in such full, clear, concise, and exact terms as to 
enable any person skilled in the art to which it pertains, or with 
which it is most nearly connected, to make and use the invention, under 
35 U.S.C. 112, ] 1. Therefore, in situations in which it is not readily 
apparent where the specification of the application, or an application 
for which a benefit is claimed, provides written description support 
and enablement under 35 U.S.C. 112, ] 1, for a claim or a limitation of 
a claim, the examiner may require the applicant to provide such 
information. The Office considers this authority to be inherent under 
the patent statute and existing rules (including Sec.  1.105), but is 
revising Sec.  1.105 to make the authority explicit.
    Section 1.110 (inventorship and date of invention of the subject 
matter of individual claims): Section 1.110 is amended to refer to 
Sec.  1.78, rather than a specific paragraph (paragraph (c)) of Sec.  
1.78. The first sentence of Sec.  1.110 is also amended to relocate the 
phrase ``when necessary for purposes of an Office proceeding'' to the 
end of the sentence for clarity.
    Section 1.114 (request for continued examination): Under Sec.  
1.114, an applicant is permitted to file a single request for continued 
examination without a petition and showing in a single application 
family. See Sec.  1.114(f)(1). An application family includes the 
initial application and its continuation or continuation-in-part 
applications. An applicant is also permitted to file a single request 
for continued examination without a petition and showing in a 
divisional application family. See Sec. Sec.  1.114(f)(2) and (f)(3). A 
divisional application family includes the divisional application and 
its continuation applications. An applicant may file a second or 
subsequent request for continued examination if the applicant files a 
petition and a showing that the amendment, argument, or evidence sought 
to be entered could not have been submitted earlier. See Sec.  
1.114(g).
    Section 1.114(a) is amended to make clear that an applicant may not 
file an unrestricted number of requests for continued examination, that 
a request for continued examination must include a petition under Sec.  
1.114(g) unless the conditions set forth in Sec.  1.114(f)(1), (f)(2), 
or (f)(3) are satisfied, and that a request for continued examination 
must be identified as a request for continued examination. Section 
1.114(a) otherwise contains the provisions of former Sec.  1.114(a).
    Section 1.114(d) is revised to eliminate the sentence ``[i]f an 
applicant timely files a submission and fee set forth in Sec.  1.17(e), 
the Office will withdraw the finality of any Office action and the 
submission will be entered and considered.'' This change is to avoid 
misleading applicants into believing that the Office will pro forma 
withdraw the finality of any Office action and the submission will be 
pro forma entered and considered upon timely filing of a submission and 
fee set forth in Sec.  1.17(e). Under revised Sec.  1.114, a second or 
subsequent request for continued examination must also include a 
petition accompanied by the fee set forth in Sec.  1.17(f) except under 
the conditions set forth in Sec.  1.114(f).
    Section 1.114(f) provides the conditions under which an applicant 
may file a request for continued examination under Sec.  1.114 without 
a petition under Sec.  1.114(g).
    Section 1.114(f)(1) permits an applicant to file a single request 
for continued examination in any one (but only one) of an initial 
application or its continuation applications or

[[Page 46738]]

continuation-in-part applications. Section 1.114(f)(1) provides that an 
applicant may file a request for continued examination under Sec.  
1.114 without a petition under Sec.  1.114(g) if a request for 
continued examination has not been previously been filed in any of: (1) 
The application; (2) any application whose benefit is claimed in the 
application under 35 U.S.C. 120, 121, or 365(c); and (3) any 
application that claims the benefit under 35 U.S.C. 120, 121, or 365(c) 
of the application, not including any nonprovisional application that 
satisfies the conditions set forth in Sec.  1.78(d)(1)(ii), 
1.78(d)(1)(iii) or 1.78(d)(1)(vi). For example, if applicant filed one 
request for continued examination in an initial application, applicant 
is precluded from filing a second request for continued examination in 
the initial application and in any continuation applications or 
continuation-in-part applications that claim the benefit of the initial 
application (not including any nonprovisional application that 
satisfies the conditions set forth in Sec.  1.78(d)(1)(ii), 
1.78(d)(1)(iii) or 1.78(d)(1)(vi)), without a petition under Sec.  
1.114(g).
    Section 1.114(f)(2) permits an applicant to file a single request 
for continued examination under Sec.  1.114 in a divisional application 
meeting the conditions set forth in Sec.  1.78(d)(1)(ii) provided that 
no request for continued examination has been filed in any continuation 
application of the divisional application. Section 1.114(f)(2) provides 
that an applicant may file a request for continued examination under 
Sec.  1.114 in a divisional application without a petition under Sec.  
1.114(g) if a request for continued examination has not previously been 
filed in any of: (1) The divisional application; and (2) any 
application that claims the benefit under 35 U.S.C. 120, 121, or 365(c) 
of that divisional application, not including any nonprovisional 
application that satisfies the conditions set forth in Sec.  
1.78(d)(1)(ii), (d)(1)(iii) or (d)(1)(vi).
    Section 1.114(f)(3) permits an applicant to file a single request 
for continued examination in a continuation application of a divisional 
application meeting the conditions set forth in Sec.  1.78(d)(1)(ii) 
provided that no request for continued examination has been filed in 
the divisional application or any other continuation application of the 
divisional application. Section 1.114(f)(3) provides that an applicant 
may file a request for continued examination under Sec.  1.114 in a 
continuation application of a divisional application without a petition 
under Sec.  1.114(g) if a request for continued examination has not 
previously been filed in any of: (1) The continuation application; (2) 
the divisional application; and (3) any other application that claims 
the benefit under 35 U.S.C. 120, 121, or 365(c) of that divisional 
application, not including any nonprovisional application that 
satisfies the conditions set forth in Sec.  1.78(d)(1)(ii), (d)(1)(iii) 
or (d)(1)(vi).
    The provisions of Sec.  1.114(f) are illustrated with the following 
example (the example used to illustrate the provisions of Sec. Sec.  
1.78(d)(1)(i) through (d)(1)(iii)): (1) There is an initial application 
``A'' that is subject to a restriction requirement under 35 U.S.C. 121 
and Sec.  1.141 et seq.; (2) a continuation application ``B'' of 
application ``A''; (3) a further continuation application ``C'' which 
claims the benefit of continuation application ``B'' and initial 
application ``A''; (4) a divisional application ``D'' (based upon the 
restriction requirement under 35 U.S.C. 121 and Sec.  1.141 et seq. in 
application ``A''), which claims the benefit of continuation 
application ``C'', continuation application ``B'', and initial 
application ``A''; (5) a continuation application ``E'' of divisional 
application ``D'', which claims the benefit of divisional application 
``D'', continuation application ``C'', continuation application ``B'', 
and initial application ``A''; and (6) a further continuation 
application ``F'' of continuation application ``E'', which claims the 
benefit of continuation application ``E'', divisional application 
``D'', continuation application ``C'', continuation application ``B'', 
and initial application ``A''.
    Section 1.114(f)(1) permits the filing of a single request for 
continued examination without a petition under Sec.  1.114(g) in any 
one of applications ``A'', ``B'', or ``C''. Specifically, a request for 
continued examination may be filed in application ``A'', if a request 
for continued examination has not previously been filed in any of: (1) 
application ``A''; (2) any application (none) whose benefit is claimed 
in application ``A''; and (3) any application (applications ``B'' and 
``C'') that claims the benefit of application ``A'', not including 
divisional application ``D'' and its continuation applications ``E'' 
and ``F''. In addition, a request for continued examination may be 
filed in application ``B'', if a request for continued examination has 
not previously been filed in any of: (1) Application ``B''; (2) any 
application (application ``A'') whose benefit is claimed in application 
``B''; and (3) any application (application ``C'') that claims the 
benefit of application ``B'', not including divisional application 
``D'' and its continuation applications ``E'' and ``F''. Finally, a 
request for continued examination may be filed in application ``C'', if 
a request for continued examination has not previously been filed in 
any of: (1) Application ``C''; (2) any application (applications ``A'' 
and ``B'') whose benefit is claimed in application ``C''; and (3) any 
application (none) that claims the benefit of application ``C'', not 
including divisional application ``D'' and its continuation 
applications ``E'' and ``F''.
    Section 1.114(f)(2) permits the filing of a single request for 
continued examination without a petition under Sec.  1.114(g) in 
application ``D'', if a request for continued examination has not 
previously been filed in application ``E'' or application ``F''. 
Specifically, a request for continued examination may be filed in 
application ``D'', if a request for continued examination has not 
previously been filed in any of: (1) Divisional application ``D''; and 
(2) any application (applications ``E'' and ``F'') that claims the 
benefit of divisional application ``D''.
    Section 1.114(f)(3) permits the filing of a single request for 
continued examination without a petition under Sec.  1.114(g) in any 
one of applications ``E'' or ``F'', if a request for continued 
examination has not previously been filed in application ``D''. 
Specifically, a request for continued examination may be filed in 
continuation application ``E'', if a request for continued examination 
has not previously been filed in any of: (1) Continuation application 
``E''; (2) divisional application ``D''; and (3) any other application 
(application ``F'') that claims the benefit of divisional application 
``D''. In addition, a request for continued examination may be filed in 
continuation application ``F'', if a request for continued examination 
has not previously been filed in any of: (1) continuation application 
``F''; (2) divisional application ``D''; and (3) any other application 
(application ``E'') that claims the benefit of divisional application 
``D''.
    Section 1.114(g) provides that a request for continued examination 
must include a petition accompanied by the fee set forth in Sec.  
1.17(f) and a showing that the amendment, argument, or evidence sought 
to be entered could not have been submitted before the close of 
prosecution in the application. A petition under Sec.  1.114(g) and the 
fee set forth in Sec.  1.17(f) are not required if the

[[Page 46739]]

conditions set forth in Sec.  1.114(f) are satisfied. Since a petition 
under Sec.  1.114(g) requires a showing that there is an amendment, 
argument, or evidence that could not have been submitted prior to the 
close of prosecution in the application, a petition under Sec.  
1.114(g) for a request for continued examination including only an 
information disclosure statement as the submission required by Sec.  
1.114(c) (i.e., not including an amendment, argument, or evidence) 
would not be granted.
    Thus, an applicant may file a single request for continued 
examination without a petition under Sec.  1.114(g) in any one (but 
only one) of an initial application or its continuation applications or 
continuation-in-part applications. An applicant may also file a single 
request for continued examination without a petition under Sec.  
1.114(g) in any one (but only one) of a divisional application (meeting 
the conditions set forth in Sec.  1.78(d)(1)(ii)) or its continuation 
applications. Any second or subsequent request for continued 
examination in an application or application family must include a 
petition, accompanied by the fee set forth in Sec.  1.17(f), and a 
showing that the amendment, argument, or evidence sought to be entered 
could not have been submitted prior to the close of prosecution in the 
application.
    Section 1.114(h) provides that the filing of an improper request 
for continued examination, including a request for continued 
examination with a petition under Sec.  1.114(g) that is not grantable, 
will not stay any period for reply or other proceedings. This is 
consistent with the current practice for requests for continued 
examination. See MPEP Sec.  706.07(h), subsection V (the mere request 
for continued examination and fee will not operate to toll the running 
of any time period set in the previous Office action for reply to avoid 
abandonment of the application).
    The Office proposed Sec.  1.114(f) to include: ``[a]ny other 
proffer of a request for continued examination in an application not on 
appeal will be treated as a submission under Sec.  1.116. Any other 
proffer of a request for continued examination in an application on 
appeal will be treated only as a request to withdraw the appeal.'' See 
Changes to Practice for Continuing Applications, Requests for Continued 
Examination Practice, and Applications Containing Patentably Indistinct 
Claims, 71 FR at 61, 1302 Off. Gaz. Pat. Office 1329. This final rule 
does not adopt that proposed change because it is unnecessary. Section 
1.116 applies only to amendments, affidavits, and other evidence filed 
after the mailing of a final Office action but prior to an appeal. 
However, applicants are permitted to file a request for continued 
examination under Sec.  1.114 after the mailing of a notice of 
allowance or an action that otherwise closes prosecution in the 
application (e.g., an Office action under Ex parte Quayle, 1935 Dec. 
Comm'r Pat. 11 (1935)). See Sec.  1.114(b). Furthermore, Sec.  1.114(d) 
already provides for the situation in which a request for continued 
examination is filed in an application on appeal.
    As discussed previously, applicants are permitted to file two 
continuation or continuation-in-part applications and a single request 
for continued examination without any justification. The provisions of 
Sec.  1.78(d)(1) are independent of the provisions of Sec.  1.114. 
Thus, filing a request for continued examination does not preclude an 
applicant from filing a first or second continuation application (or 
continuation-in-part application). In addition, an applicant may not 
agree to forgo a first or second continuation application (or 
continuation-in-part application) to obtain a second or third request 
for continued examination, nor can applicant forgo a request for 
continued examination to obtain a third continuation or continuation-
in-part application. For example, an applicant cannot file two requests 
for continued examination without a petition and showing in an 
application instead of filing one of the two permitted continuation 
applications.
    The Office is implementing an optional streamlined continuation 
application procedure under which an applicant may have a continuation 
application placed on an examiner's amended (Regular Amended) docket 
(see discussion of Sec.  1.78(d)(1)(i)). Thus, an applicant may 
effectively obtain the docketing benefit (i.e., being placed on an 
examiner's amended (Regular Amended) docket) of a second and third 
request for continued examination without a petition under Sec.  
1.114(g) by requesting that the two continuation applications permitted 
under Sec.  1.78(d)(1)(i) be treated under the optional streamlined 
continuation application procedure.
    The changes to Sec.  1.114 apply to any application in which a 
request for continued examination is filed on or after November 1, 
2007. Thus, a request for continued examination filed on or after 
November 1, 2007, in an application in which a request for continued 
examination has previously been filed, in a continuation or 
continuation-in-part application of an application in which a request 
for continued examination has previously been filed, or in an 
application whose benefit is claimed in any other nonprovisional 
application in which a request for continued examination has previously 
been filed, must include a petition under Sec.  1.114(g). That is, an 
applicant may file a request for continued examination (and not ``one 
more'' request for continued examination) on or after November 1, 2007, 
without a petition under Sec.  1.114(g) only if the conditions set 
forth in Sec.  1.114(f)(1), (f)(2), or (f)(3) are met.
    Section 1.117 (refund due to cancellation of claim): The 
Consolidated Appropriations Act provides that 35 U.S.C. 41(a), (b), and 
(d) shall be administered in a manner that revises patent application 
fees (35 U.S.C. 41(a)) and patent maintenance fees (35 U.S.C. 41(b)), 
and provides for a separate filing fee (35 U.S.C. 41(a)), search fee 
(35 U.S.C. 41(d)(1)), and examination fee (35 U.S.C. 41(a)(3)) during 
fiscal years 2005 and 2006. See Public Law 108-447, 118 Stat. 2809 
(2004). The Consolidated Appropriations Act also provides that the 
Office may, by regulation, provide for a refund of any part of the 
excess claim fee specified in 35 U.S.C. 41(a)(2) for any claim that is 
canceled before an examination on the merits has been made of the 
application under 35 U.S.C. 131. See 35 U.S.C. 41(a)(2) (as 
administered during fiscal years 2005 and 2006 pursuant to the 
Consolidated Appropriations Act). The Revised Continuing Appropriations 
Resolution, 2007 (Pub. L. 110-5, 121 Stat. 8 (2007)), keeps the patent 
fee and fee structure provisions of the Consolidated Appropriations 
Act, 2005, in effect during fiscal year 2007 (until September 30, 
2007).
    Section 1.117 is added to implement this provision of the 
Consolidated Appropriations Act. Section 1.117(a) provides that if an 
amendment canceling a claim is filed before an examination on the 
merits has been made of the application, the applicant may request a 
refund of any fee under Sec.  1.16(h), (i), or (j) or under Sec.  
1.492(d), (e), or (f) paid on or after December 8, 2004, for such 
claim. Thus, if an applicant decides to cancel the claims in excess of 
five independent claims and in excess of twenty-five total claims 
rather than provide an examination support document in compliance with 
Sec.  1.265, the applicant may request a refund of any fee for such 
claim that is paid on or after December 8, 2004. Section 1.117(a) as 
adopted, however, does not require that the amendment have been filed 
in reply to a notice under Sec.  1.75(b)(3). Section 1.117(a) requires 
only that the amendment have been filed before an examination on the

[[Page 46740]]

merits has been made of the application. The Consolidated 
Appropriations Act authorizes a refund only for a claim that has been 
canceled before an examination on the merits has been made of the 
application under 35 U.S.C. 131. The Office thus lacks authority to 
grant a refund either on the basis of: (1) The withdrawal from 
consideration of a claim directed to a non-elected invention or 
species; or (2) the cancellation of a claim after an examination on the 
merits has been made of the application under 35 U.S.C. 131. Section 
1.117(a) also provides that if an amendment adding one or more claims 
is also filed before the application has been taken up for examination 
on the merits, the Office may apply any refund under Sec.  1.117 to any 
excess claims fees due as a result of such an amendment. The date 
indicated on any certificate of mailing or transmission under Sec.  1.8 
will not be taken into account in determining whether an amendment 
canceling a claim was filed before an examination on the merits has 
been made of the application.
    ``[A]n examination on the merits has been made of the 
application'' for purposes of Sec.  1.117(a) once a first Office action 
on the merits, notice of allowability or allowance, or action under Ex 
parte Quayle is shown in the Patent Application Locating and Monitoring 
(PALM) system as having been counted. For purposes of Sec.  1.117(a), 
``before'' means at least one day before. If an amendment canceling a 
claim is filed and an Office action is counted on the same day, the 
amendment canceling a claim was not filed before an examination on the 
merits has been made of the application. The Patent Application 
Information Retrieval (PAIR) system is a system that provides public 
access to PALM for patents and applications that have been published. 
The PAIR system does not provide public access to information 
concerning applications that are maintained in confidence under 35 
U.S.C. 122(a). Applicants, however, may use the private side of PAIR to 
access confidential information about their pending application. To 
access the private side of PAIR, a customer number must be associated 
with the correspondence address for the application, and the user of 
the system must have a digital certificate. For further information, 
contact the Customer Support Center of the Electronic Business Center 
at (571) 272-4100 or toll free at (866) 217-9197.
    Section 1.117(b) (Sec.  1.117(c) as proposed) provides that if a 
request for refund under this section is not filed within two months 
from the date on which the claim was canceled, the Office may retain 
the excess claims fee paid in the application. This two-month period is 
not extendable. If an amendment canceling a claim is not filed before 
an examination on the merits, the Office will not refund any part of 
the excess claims fee paid in the application except as provided in 
Sec.  1.26.
    The provisions of Sec.  1.117(b) as proposed are duplicative of the 
provisions of Sec.  1.138(d) and have not been adopted as unnecessary.
    The patent fee provisions of the Consolidated Appropriations Act 
expire (in the absence of additional legislation) on September 30, 2007 
(at the end of fiscal year 2007). Therefore, in the absence of 
subsequent legislation, the refund provision in Sec.  1.117 will 
likewise expire on September 30, 2007 (at the end of fiscal year 2007), 
regardless of the date on which the excess claims fee was paid.
    Section 1.136 (extensions of time): Section 1.136(a)(1) is amended 
to add ``[t]he reply is to a notice requiring compliance with Sec.  
1.75(b) or Sec.  1.265'' to the enumerated list of replies to which the 
extension of time provision of Sec.  1.136(a) is not applicable. A 
notice under Sec.  1.75(b)(3) is a ``notice requiring compliance with 
Sec.  1.75(b).'' A ``notice requiring compliance with Sec.  1.75(b)'' 
would include a notice mailed before the issuance of a first Office 
action on the merits setting a two-month time period within which the 
applicant must: (1) File an examination support document in compliance 
with Sec.  1.265; or (2) amend the application such that it contains no 
more than five independent claims and no more than twenty-five total 
claims. A ``notice requiring compliance with Sec.  1.75(b)'' would also 
include a notice issued after a first Office action on the merits in an 
application in which the applicant is given a time period within which 
the applicant must amend the application such that it contains no more 
than five independent claims and no more than twenty-five total claims. 
For example, if a reply to a non-final Office action on the merits 
seeks to amend an application such that it contains more than five 
independent claims and more than twenty-five total claims, the reply 
would be held non-responsive and (if the non-compliance with Sec.  
1.75(b) appears to have been inadvertent) the Office would give the 
applicant a two-month time period that was not extendable under Sec.  
1.136(a) within which to provide an amendment that does not result in 
the application containing more than five independent claims or more 
than twenty-five total claims. See Sec.  1.135(c).
    Section 1.142 (requirement for restriction): Section 1.142(a) is 
amended to state that an examiner ``may'' (rather than ``will'') 
require restriction if two or more independent and distinct inventions 
are claimed in a single application. The change is for consistency with 
current Office practice under which a requirement that an application 
containing claims to two or more independent and distinct inventions be 
restricted to a single invention is discretionary (see 35 U.S.C. 121 
and MPEP Sec.  803.01). An application containing claims to two or more 
independent and distinct inventions typically is not restricted to a 
single invention if the search and examination of all of the claims in 
the application can be made without serious burden (see MPEP section 
803).
    Section 1.142(c) is added to permit applicants to suggest 
requirements for restriction. Specifically, Sec.  1.142(c) provides 
that if two or more independent and distinct inventions are claimed in 
a single application, the applicant may file a suggested requirement 
for restriction under Sec.  1.142(c). Any suggested requirement for 
restriction must be filed before the earlier of the first Office action 
on the merits or an Office action that contains a requirement to comply 
with the requirement of unity of invention under PCT Rule 13 or a 
requirement for restriction under 35 U.S.C. 121 in the application. It 
must also be accompanied by an election without traverse of an 
invention to which there are no more than five independent claims and 
no more than twenty-five total claims, and must identify the claims to 
the elected invention. Claims to the non-elected invention, if not 
canceled, will be withdrawn from further consideration by the examiner. 
If the examiner accepts the suggested restriction, then the claims to 
the non-elected invention, if not canceled by the applicant, will be 
withdrawn from further consideration by the examiner. See the 
discussion of Sec. Sec.  1.75(b)(5) and 1.78(d)(1)(ii).
    Section 1.75(b)(3)(iii) as proposed would have permitted applicants 
to reply to a notice from the Office that an application contains more 
than ten representative claims (under certain conditions) by submitting 
a suggested requirement for restriction accompanied by an election 
without traverse of an invention to which there are no more than five 
independent claims and no more than twenty-five total claims. See 
Changes to Practice for the Examination of Claims in Patent 
Applications, 71 FR

[[Page 46741]]

at 64, 67-68, 1302 Off. Gaz. Pat. Office 1331, 1334. However, because 
the ``representative claims'' examination approach is not adopted in 
this final rule, this proposed provision of Sec.  1.75(b)(3)(iii) is 
unnecessary. In this final rule, applicants may file a suggested 
requirement for restriction accompanied by an election without traverse 
(Sec.  1.142(c)) of an invention to which there are no more than five 
independent claims and no more than twenty-five total claims without 
first awaiting a notice from the Office under Sec.  1.75(b)(3).
    Section 1.142(c) further provides that if the applicant's suggested 
requirement for restriction is accepted, the restriction requirement 
will be set forth in a subsequent Office action. Any claim to the non-
elected invention or inventions, if not canceled, is by the election 
withdrawn from further consideration.
    If the suggested requirement for restriction is refused, the 
applicant will be notified in an Office action. That Office action may 
include, a notice under Sec.  1.75(b)(3) requiring applicant to file an 
examination support document or amend the application to contain no 
more than five independent claims or no more than twenty-five total 
claims. If an applicant's suggested restriction requirement is refused, 
the examiner may make a different restriction requirement or make no 
restriction requirement. 35 U.S.C. 121 authorizes, but does not compel, 
the Director to require that an application containing two or more 
independent and distinct inventions be restricted to one of the 
inventions. A decision not to restrict an application to a single 
invention is not an action or requirement within the meaning of Sec.  
1.181(a). Thus, any review of an examiner's requirement for restriction 
that differs from a suggested restriction requirement will only concern 
the appropriateness of the examiner's restriction requirement and will 
not address the appropriateness of the applicant's suggested 
restriction requirement or compare the examiner's restriction 
requirement and the suggested restriction requirement.
    Section 1.145 (subsequent presentation of claims for different 
invention): Section 1.145 is amended to state that an applicant ``may'' 
(rather than ``will'') be required to restrict the claims to the 
invention previously claimed if, after an Office action on an 
application, the applicant presents claims directed to an invention 
distinct from and independent of the invention previously claimed (see 
discussion of Sec.  1.142(a)). Section 1.145 is amended to add ``on the 
merits'' to clarify that Sec.  1.145 applies only after a first Office 
action on the merits.
    Section 1.265 (examination support document): Section 1.265 is 
added to set forth what an ``examination support document'' entails. An 
examination support document is required under Sec.  1.75(b)(1) when an 
applicant presents more than five independent claims or more than 
twenty-five total claims in an application. See Sec.  1.75(b)(1) and 
the discussion of Sec.  1.75(b)(1). Section 1.265(a) sets forth the 
requirements for an examination support document. Section 1.265(b) 
provides for the requirements of the preexamination search required 
under Sec.  1.265(a)(1). Section 1.265(c) provides for the requirements 
of the listing of references required under Sec.  1.265(a)(2). Section 
1.265(d) provides for certain situations in which a supplemental 
examination support document is required when applicant files an 
information disclosure statement citing additional references. Section 
1.265(e) provides for situations in which the examination support 
document is insufficient. Section 1.265(f) provides an exemption to 
applications filed by a small entity as defined by the Regulatory 
Flexibility Act (5 U.S.C. 601 et seq.). The exemption is for the 
requirement in Sec.  1.265(a)(3) that an examination support document 
must include an identification of all of the claim limitations (whether 
in independent or dependent form) that are disclosed by the cited 
references.
    Section 1.265 contains fewer requirements than an accelerated 
examination support document under the revised procedures for certain 
petitions to make special (see Changes to Practice for Petitions in 
Patent Applications To Make Special and for Accelerated Examination, 71 
FR 36232 (June 26, 2006), 1308 Off. Gaz. Pat. Office 106 (July 18, 
2006) (notice)). For example, Sec.  1.265 does not require that the 
examination support document identify any cited references that may be 
disqualified as prior art under 35 U.S.C. 103(c) as amended by the 
Cooperative Research and Technology Act (although applicants are 
encouraged to identify any cited references that may be so 
disqualified). Thus, the Office's guidelines concerning the accelerated 
examination support document may be helpful to applicants who are 
preparing an examination support document under Sec.  1.265. The 
guidelines under the revised accelerated examination procedure, search 
templates, and samples of a preexamination search document and an 
examination support document can be found on the Office's Internet Web 
site at http://www.uspto.gov/web/patents/accelerated/. The Office will 
provide similar guidelines for examination support document under Sec.  
1.265 and will post such guidelines on the Office's Internet Web site.
    Section 1.265(a)(1) provides that an examination support document 
must include a statement that a preexamination search in compliance 
with Sec.  1.265(b) was conducted. The examination support document 
must identify (in the manner set forth in MPEP Sec.  719.05) the field 
of search by class and subclass and the date of the search, where 
applicable. For database searches, the examination support document 
must identify the search logic or chemical structure or sequence used 
as a query, the name of the file or files searched and the database 
service, and the date of the search.
    Section 1.265(a)(2) provides that an examination support document 
must include a listing in compliance with Sec.  1.265(c) of the 
reference or references deemed most closely related to the subject 
matter of each of the claims (whether in independent or dependent 
form). The references that would be most closely related to the subject 
matter of each of the claims include: (1) A reference that discloses 
the most number of limitations in an independent claim; (2) a reference 
that discloses a limitation of an independent claim that is not shown 
in any other reference in the listing of references required under 
Sec.  1.265(a)(2); and (3) a reference that discloses a limitation of a 
dependent claim that is not shown in any other reference in the listing 
of references required under Sec.  1.265(a)(2). References that are 
only relevant to the general subject matter of the claims would not be 
most closely related to the subject matter of each of the claims if 
there are other references that are deemed to be more closely related 
to the subject matter of the claims.
    It is envisioned that the reference or references presented as 
being most closely related to the subject matter of the claims will 
generally be references that result from the preexamination search 
provided for in Sec.  1.265(a)(1). The preexamination search provided 
for in Sec.  1.265(a)(1) should result in the reference or references 
that are most closely related to the subject matter of the claims. 
However, an applicant may not exclude a reference from an examination 
support document simply because the reference was not the result of the 
preexamination search provided for in Sec.  1.265(a)(1). The reference, 
for instance, may have been brought to applicant's attention via a 
foreign or PCT search report. References that have

[[Page 46742]]

been brought to the applicant's attention regardless of the source of 
those references must be considered in identifying the reference or 
references most closely related to the subject matter of each of the 
claims.
    Section 1.265(a)(3) provides that an examination support document 
must, for each reference in the listing of references required under 
Sec.  1.265(a)(2), identify all of the limitations of each of the 
claims (whether in independent or dependent form) that are disclosed by 
the reference. Applicant may satisfy this requirement either by mapping 
the limitations of each of the claims to the references or by mapping 
the references to the limitations of the claims. Applicants may map the 
limitations of each of the claims to the references by, for each claim, 
identifying where the cited references disclose features, showings, or 
teachings that are relevant to each limitation of such claim. 
Applicants may map the references to the limitations of the claims by, 
for each cited reference, identifying where the reference discloses 
features, showings, or teachings that are relevant to the limitations 
of each of the claims.
    Section 1.265(a)(3) requires the applicant to identify at least one 
appearance in the reference (a representative portion) of a specific 
feature, showing, or teaching for which the reference is being cited. 
If the feature, showing, or teaching appears in more than one portion 
of the reference, applicant would not need to specifically point out 
more than one occurrence. Applicant, however, should do so where the 
additional appearance may not be apparent to the examiner and may have 
some additional significance over its first identified appearance. If 
an applicant recognizes that a document is relevant for more than one 
feature, showing, or teaching, the applicant would need to specifically 
identify each additional feature, showing, or teaching and the portion 
where the feature, showing, or teaching appears in the document. A mere 
statement indicating that the entire reference, or substantially the 
entire reference, is relevant would not comply with Sec.  1.265(a)(3).
    Section 1.265(a)(4) provides that an examination support document 
must include a detailed explanation particularly pointing out how each 
of the independent claims is patentable over the references cited in 
the listing of references required under Sec.  1.265(a)(2). The 
explanation required by Sec.  1.265(a)(4) may be set forth together 
with the identification required by Sec.  1.265(a)(3) or may be 
provided separately. For example, the identification required by Sec.  
1.265(a)(3) and the explanation required by Sec.  1.265(a)(4) may be 
set out in a single spreadsheet with two columns, or may be set out in 
two spreadsheets. A general statement that all of the claim limitations 
are not described in a single reference does not satisfy the 
requirements of Sec.  1.265(a)(4). Section 1.265(a)(4) requires that 
the examination support document set out with particularity, by 
reference to one or more specific claim limitations, why the claimed 
subject matter is not described in the references, taken as a whole. 
The applicant must explain why a person of ordinary skill in the art 
would not have combined the features disclosed in one reference with 
features disclosed in another reference to arrive at the claimed 
subject matter. The applicant must also explain why the claim 
limitations referenced render the claimed subject matter novel and non-
obvious over the cited prior art.
    Section 1.265(a)(5) provides that an examination support document 
must include a showing of where each limitation of the claims (whether 
in independent or dependent form) finds support under 35 U.S.C. 112, ] 
1, in the written description of the specification. If the application 
claims the benefit of one or more applications under title 35, United 
States Code, the showing must also include where each limitation of the 
claims finds support under 35 U.S.C. 112, ] 1, in each such application 
in which such support exists. For means- (or step-) plus-function claim 
elements under 35 U.S.C. 112, ] 6, this requires: (1) That the claim 
limitation be identified as means- (or step-) plus-function claim 
element under 35 U.S.C. 112, ] 6; and (2) that the structure, material, 
or acts in the specification that correspond to each means- (or step-) 
plus-function claim element under 35 U.S.C. 112, ] 6, be identified. 
See Changes to Practice for Petitions in Patent Applications To Make 
Special and for Accelerated Examination, 71 FR at 36325, 1308 Off. Gaz. 
Pat. Office at 107.
    If the examiner, after considering the application and any 
examination support document, still has questions concerning the 
invention or how the claims define over the prior art or are 
patentable, the examiner may request an interview before the first 
Office action. If the applicant declines such a request for an 
interview or if the interview does not result in the examiner obtaining 
the necessary information, the examiner may issue a requirement for 
information under Sec.  1.105 to obtain such information. Section 
1.133(a)(2) was amended in November of 2005 to permit an interview 
before the first Office action if the examiner determines that such an 
interview would advance prosecution. See Provisions for Claiming the 
Benefit of a Provisional Application With a Non-English Specification 
and Other Miscellaneous Matters, 70 FR at 56121, 56128, 1299 Off. Gaz. 
Pat. Office at 144, 150. Applicant may request an interview before the 
first Office action. Such a request is ordinarily granted in a 
continuing application or if the examiner determines that the interview 
would advance prosecution. See Sec.  1.133(a)(2) and MPEP Sec.  713.02.
    Section 1.265(b) provides that the preexamination search must 
involve U.S. patents and patent application publications, foreign 
patent documents, and non-patent literature, unless the applicant can 
justify with reasonable certainty that no references more pertinent 
than those already identified are likely to be found in the eliminated 
source. That justification must be included in the statement required 
by Sec.  1.265(a)(1). Section 1.265(b) also provides that the 
preexamination search must encompass all of the limitations of the 
independent claims. It must also encompass all of the limitations of 
the dependent claims separately from the claim or claims from which 
they depend. The claims must be given the broadest reasonable 
interpretation. A search report from a foreign patent office will not 
automatically satisfy the requirement in Sec.  1.265(a)(1) for a 
preexamination search unless it includes the information required by 
Sec.  1.265.
    Section 1.265(c) provides for the content requirements of the 
listing of references required under Sec.  1.265(a)(2) as part of an 
examination support document. Section 1.265(c) provides the same 
content requirements as those that are currently provided in Sec. Sec.  
1.98(a) and (b). Specifically, Sec.  1.265(c) provides that the listing 
of references required under Sec.  1.265(a)(2) as part of an 
examination support document must include a list identifying each of 
the cited references (Sec. Sec.  1.265(c)(1) and (c)(2)), a copy of 
each reference except for references that are U.S. patents or U.S. 
patent application publications (Sec.  1.265(c)(3)), and each English 
language translation if required by Sec.  1.265(c)(4). Applicant may 
use the USPTO form, ``Examination Support Document Listing of 
References,'' to submit the listing of references. The form will be 
available on the Office's Internet Web site at http://www.uspto.gov/web/forms/index.html#patent.
    Section 1.265(c)(1) provides that the list of cited references must 
group U.S. patents and U.S. patent application publications (including 
international

[[Page 46743]]

applications designating the United States) in a section separate from 
other references. Section 1.265(c)(1) also provides that each page of 
the list of the cited references must include: (1) The application 
number, if known, of the application in which the examination support 
document is being filed; (2) a column that provides a space next to 
each cited reference for the examiner's initials; and (3) a heading 
that clearly indicates that the list is part of an examination support 
document listing of references.
    Section 1.265(c)(2) provides that the list of cited references must 
identify each cited reference as follows: (1) Each U.S. patent must be 
identified by first named patentee, patent number, and issue date; (2) 
each U.S. patent application publication must be identified by 
applicant, patent application publication number, and publication date; 
(3) each U.S. application must be identified by the applicant, 
application number, and filing date; (4) each foreign patent or 
published foreign patent application must be identified by the country 
or patent office which issued the patent or published the application, 
an appropriate document number, and the publication date indicated on 
the patent or published application; and (5) each publication must be 
identified by publisher (e.g., name of journal), author (if any), 
title, relevant pages of the publication, publication date, and place 
of publication.
    Section 1.265(c)(4) provides that if a non-English language 
document is being cited, any existing English language translation of 
the non-English language document must be submitted if the translation 
is within the possession, custody, or control of, or is readily 
available to any individual identified in Sec.  1.56(c).
    Section 1.265(d) provides for a supplemental examination support 
document. If an information disclosure statement is filed in an 
application in which an examination support document is required and 
has been filed, the applicant must also file a supplemental examination 
support document addressing the references cited in the information 
disclosure statement in the manner required under Sec. Sec.  
1.265(a)(3) and (a)(4), unless the information disclosure statement 
cites only references that are less closely related to the subject 
matter of one or more claims than the references cited in the 
examination support document listing of references required under Sec.  
1.265(a)(2).
    Section 1.265(e) provides that the applicant will be notified if: 
(1) The examination support document or preexamination search is deemed 
to be insufficient; or (2) the claims have been amended such that the 
examination support document no longer covers each claim. The notice 
will give the applicant a two-month time period within which the 
applicant must either file a corrected or supplemental examination 
support document or amend the application such that it contains no more 
than five independent claims and no more than twenty-five total claims 
in order to avoid abandonment. Section 1.265(e) further provides that 
this two-month period is not extendable under Sec.  1.136(a).
    Section 1.265(f) provides an exemption from the requirement in 
Sec.  1.265(a)(3) that an examination support document must, for each 
reference cited in the listing of references required under Sec.  
1.265(a)(2), include an identification of all of the limitations of 
each of the claims (whether in independent or dependent form) that are 
disclosed by the reference that applies to applications by a small 
entity as defined by the Regulatory Flexibility Act (5 U.S.C. 601 et 
seq.). The Regulatory Flexibility Act defines a ``small entity'' as a 
``small business'' as defined in 5 U.S.C. 601(3), a ``small 
organization'' as defined in 5 U.S.C. 601(4), and a ``small 
governmental jurisdiction'' as defined 5 U.S.C. 601(5). See 5 U.S.C. 
601(6). Section 1.265(f) specifically provides that an examination 
support document, or a corrected or supplemental examination support 
document, is not required to comply with the requirements set forth in 
Sec.  1.265(a)(3) if the examination support document is accompanied by 
a certification that any rights in the application have not been 
assigned, granted, conveyed, or licensed, and there is no obligation 
under contract or law to assign, grant, convey, or license any rights 
in the application, other than a security interest that has not been 
defaulted upon, to any entity other than a business or other concern as 
defined in Sec.  1.265(f)(1), a not-for-profit enterprise as defined in 
Sec.  1.265(f)(2), or a government as defined in Sec.  1.265(f)(3). A 
business or other concern which meets the definition set forth in Sec.  
1.265(f)(1), a not-for-profit enterprise that meets the definition set 
forth in Sec.  1.265(f)(2), or a government that meets the definition 
set forth in Sec.  1.265(f)(3) may make the certification provided for 
in Sec.  1.265(f) regardless of whether the business or other concern, 
not-for-profit enterprise, or government is located in or operates 
primarily in the United States.
    With respect to the business or other concerns defined in Sec.  
1.265(f)(1), the Regulatory Flexibility Act provides that ``the term 
`small business' has the same meaning as the term `small business 
concern' under section 3 of the Small Business Act, unless an agency, 
after consultation with the Office of Advocacy of the Small Business 
Administration and after opportunity for public comment, establishes 
one or more definitions of such term which are appropriate to the 
activities of the agency and publishes such definition(s) in the 
Federal Register.'' See 5 U.S.C. 601(3). The Office has established the 
standard set forth in 13 CFR 121.802 for paying reduced patent fees as 
the definition of ``small business'' for Regulatory Flexibility Act 
purposes with respect to patent-related regulations. Therefore, a 
``small business'' for Regulatory Flexibility Act purposes with respect 
to patent-related regulations is a business or other concern: (1) Whose 
number of employees, including affiliates, does not exceed 500 persons; 
and (2) which has not assigned, granted, conveyed, or licensed (and is 
under no obligation to do so) any rights in the invention to any person 
who made it and could not be classified as an independent inventor, or 
to any concern which would not qualify as a non-profit organization or 
a small business concern under this definition.
    With respect to the not-for-profit enterprises defined in Sec.  
1.265(f)(2), the Regulatory Flexibility Act provides that ``the term 
`small organization' means any not-for-profit enterprise which is 
independently owned and operated and is not dominant in its field, 
unless an agency establishes, after opportunity for public comment, one 
or more definitions of such term which are appropriate to the 
activities of the agency and publishes such definition(s) in the 
Federal Register.'' See 5 U.S.C. 601(4). The Office has not established 
any definition of ``small organization'' for Regulatory Flexibility Act 
purposes with respect to patent-related regulations. Therefore, a 
``small organization'' for Regulatory Flexibility Act purposes with 
respect to patent-related regulations is a not-for-profit enterprise 
which is independently owned and operated and is not dominant in its 
field.
    With respect to the governments defined in Sec.  1.265(f)(3), the 
Regulatory Flexibility Act provides that ``the term `small governmental 
jurisdiction' means governments of cities, counties, towns, townships, 
villages, school districts, or special districts, with a population of 
less than fifty thousand, unless an

[[Page 46744]]

agency establishes, after opportunity for public comment, one or more 
definitions of such term which are appropriate to the activities of the 
agency and which are based on such factors as location in rural or 
sparsely populated areas or limited revenues due to the population of 
such jurisdiction, and publishes such definition(s) in the Federal 
Register.'' See 5 U.S.C. 601(5). The Office has not established any 
definition of ``small governmental jurisdiction'' for Regulatory 
Flexibility Act purposes with respect to patent-related regulations. 
Therefore, a ``small governmental jurisdiction'' for Regulatory 
Flexibility Act purposes with respect to patent-related regulations is 
a government of a city, county, town, township, village, school 
district, or special district, with a population of less than fifty 
thousand.
    An entity that meets the definition of a small entity set forth in 
Sec.  1.27 for paying reduced patent fees may or may not meet one of 
the definitions under Sec. Sec.  1.265(f)(1) through (f)(3) to make a 
certification under Sec.  1.265(f). The Office will not give advisory 
opinions as to whether or not a specific individual or entity meets the 
definitions under Sec. Sec.  1.265(f)(1) through (f)(3) to make a 
certification under Sec.  1.265(f). Questions related to standards for 
small business concerns, not-for-profit enterprises, or governments may 
be directed to: Small Business Administration, Size Standards Staff, 
409 Third Street, SW., Washington, DC 20416.
    Section 1.495 (entering the national stage in the United States of 
America): Section 1.495(g) provides that if the documents and fees 
contain conflicting indications as to whether the submission is an 
application under 35 U.S.C. 111 or a submission to enter the national 
stage under 35 U.S.C. 371, the documents and fees will be treated as a 
submission to enter the national stage under 35 U.S.C. 371. It is 
Office experience that, in most cases, documents and fees that contain 
such conflicting indications were intended as submissions under 35 
U.S.C. 371.
    Section 1.704 (reduction of period of adjustment of patent term): 
Section 1.704(c) is amended to provide the patent term adjustment 
consequences of a failure to comply with Sec.  1.75(b) (e.g., a failure 
to file an examination support document in compliance with Sec.  1.265 
when necessary under Sec.  1.75(b)). Such a failure will be considered 
a circumstance that constitutes a failure of an applicant to engage in 
reasonable efforts to conclude processing or examination of an 
application under 35 U.S.C. 154(b)(2)(C). The failure to comply with 
Sec.  1.75(b) will delay processing or examination of an application 
because the Office must issue a notice and await the applicant's reply 
before examination of the application may begin. Therefore, Sec.  
1.704(c) provides for a reduction of any patent term adjustment when 
there is a failure to comply with Sec.  1.75(b). Specifically, any 
patent term adjustment will be reduced by the number of days in the 
period between the following beginning and ending dates. The beginning 
date of the period is the day after the date that is the later of: (1) 
The filing date of the amendment resulting in the noncompliance with 
Sec.  1.75(b); (2) four months from the filing date of the application 
in an application under 35 U.S.C. 111(a); or (3) four months from the 
date on which the national stage commenced under 35 U.S.C. 371(b) or 
(f) in an application which entered the national stage from an 
international application after compliance with 35 U.S.C. 371. The 
ending date of the period is the filing date of: (1) An examination 
support document in compliance with Sec.  1.265; (2) an election 
responsive to an Office-issued requirement for restriction including an 
election of species that places the application in compliance with 
Sec.  1.75(b) (e.g., the election of an invention that is drawn to five 
or fewer independent claims and twenty-five or fewer total claims that 
would obviate the need for an examination support document under Sec.  
1.265); (3) an amendment resulting in compliance with Sec.  1.75(b) 
(e.g., amending the application to contain five or fewer independent 
claims and twenty-five or fewer total claims); (4) a suggested 
requirement for restriction under Sec.  1.142(c) accompanied by an 
election without traverse of an invention to which there are no more 
than five independent claims and no more than twenty-five total claims.
    The examiner's acceptance of a suggested requirement for 
restriction accompanied by an election without traverse of an invention 
to which there are no more than five independent claims and no more 
than twenty-five total claims would be sufficient to obviate the need 
for an examination support document under Sec.  1.265. If the suggested 
requirement for restriction is not accepted, the applicant will be 
notified and given a time period within which the applicant must either 
file an examination support document or amend the application such that 
it contains no more than five independent claims and no more than 
twenty-five total claims. Failure to timely reply to such a notice 
would result in the abandonment of the application. The abandonment of 
an application results in the period of adjustment set forth in Sec.  
1.703 (if any) being reduced under Sec.  1.704(c)(3).

III. Response to Comments

    As discussed previously, the Office published notices in January of 
2006 proposing: (1) Changes to practice for continuing applications, 
requests for continued examination, and applications containing 
patentably indistinct claims; and (2) changes to the practice for the 
examination of claims in patent applications. See Changes to Practice 
for Continuing Applications, Requests for Continued Examination 
Practice, and Applications Containing Patentably Indistinct Claims, 71 
FR at 48-61, 1302 Off. Gaz. Pat. Office 1318-29, and Changes to 
Practice for the Examination of Claims in Patent Applications, 71 FR 
61-69, 1302 Off. Gaz. Pat. Office 1329-35. The Office received over 
five hundred written comments (from government agencies, universities, 
intellectual property organizations, industry, law firms, individual 
patent practitioners, and the general public) in response to this 
notice. The comments and the Office's responses to the comments follow:

A. Changes to Continuing Application Practice

    Comment 1: A number of comments stated that the changes in the 
definitions of continuation, divisional, and continuation-in-part 
applications set forth in Sec.  1.78(a) are likely to confuse the 
public and examiners and that the Office has not identified any value 
that would result from these changes. Several comments suggested that 
further guidance was needed to resolve ambiguities as to whether an 
application is a divisional or continuation application. One comment 
argued that the requirement to identify the relationship of the 
applications could create hardship when it is unclear whether the 
changes to the specification or claims make the application a 
continuation, divisional, or continuation-in-part application.
    Response: The definitional changes are necessary in order to 
clearly define the conditions for claiming benefit of prior-filed 
applications under Sec.  1.78(d)(1). This final rule further clarifies 
the definition of a divisional application set forth in Sec.  
1.78(a)(2). Under this final rule, an applicant may file a divisional 
application directed to a non-elected invention if the prior-filed 
application is subject to a requirement for restriction. The divisional 
application need not be filed during the

[[Page 46745]]

pendency of the application subject to a requirement for restriction, 
as long as the copendency requirement of 35 U.S.C. 120 is met. Thus, 
applicant may file a divisional application claiming the benefit of the 
initial application that was subject to the requirement for restriction 
and any intermediate continuing applications.
    Furthermore, the definitions of continuation, divisional, and 
continuation-in-part application set forth in Sec.  1.78(a) are 
substantially the same as the previous definitions set forth in the 
MPEP, except that a divisional application is now defined more 
narrowly. See the discussion of Sec.  1.78(a). The former practice 
permitted an applicant to file a continuing application and identify 
the application as a ``divisional'' application even when the prior-
filed application was not subject to a requirement for restriction. 
Such a continuing application was called a ``voluntary'' divisional 
application. Under this final rule, a ``voluntary'' divisional 
application would instead fall under the definition of a continuation 
application. Therefore, a continuing application would be a 
continuation application and not a divisional (``voluntary'' 
divisional) application if the prior-filed application was not subject 
to a requirement for restriction. If the prior-filed application was 
subject to a requirement for restriction, a continuing application 
claiming only a non-elected invention or inventions would be a 
divisional application. It is noted that although the definition of 
continuation application set forth in Sec.  1.78(a)(2) uses the phrase 
``invention or inventions'' rather than ``subject matter'' (as used in 
the definition of continuation application set forth in MPEP Sec.  
201.07), no substantive difference between these terms is intended. The 
requirement to identify the relationship (i.e., continuation, 
divisional, or continuation-in-part) between the prior-filed 
application and the continuing application is not a new requirement 
under this final rule. This requirement has been provided in the former 
Sec.  1.78(a)(2)(i). Accordingly, the definitions of continuation, 
divisional, and continuation-in-part application set forth in Sec.  
1.78(a) are not likely to confuse the public or examiners for any 
extended period.
    Comment 2: A number of comments observed the proposed requirement 
that a divisional application may claim the benefit of only a single 
application would require that all divisional applications filed as a 
result of a restriction requirement in a prior-filed application be 
filed before the patenting or abandonment of that application. A number 
of comments suggested that the rule changes limiting divisional 
applications to claim benefit to only a single prior-filed application 
would result in an overall increase in application filings and 
pendency, contrary to their intended purpose. The comments contended 
the changes being adopted in this final rule effectively force 
applicants to claim all patentably distinct inventions in the prior-
filed application or file related applications in parallel in order to 
preserve potential patent rights in those inventions. The comments 
suggested that since a divisional application must be filed during the 
pendency of the prior-filed application, many more divisional 
applications would be filed than would be filed under the current 
system, as applicants will not have sufficient time and information to 
determine whether the invention is worth pursuing. The comments stated 
that, consequently, the Office will be forced to examine more 
inventions than it would under current practice, wasting both 
applicants' and the Office's resources. A number of comments also 
suggested that the inability to prosecute divisional applications 
sequentially, thus allowing applicants to spread filing and prosecution 
costs over time and to file only those divisional applications that are 
commercially valuable in view of subsequent market development, will 
have a particularly negative impact on the biotechnology and 
pharmaceutical industries and on small entities. The comments suggested 
that patent rights will be lost due to a lack of funding and that the 
increased costs will be particularly onerous in certain technologies, 
e.g., biotechnology and chemical arts, where the Office routinely 
issues complex restriction requirements, sometimes alleging hundreds or 
thousands of independent and distinct inventions. Several comments also 
suggested that the rules should be modified to account for the economic 
impossibility, in many cases, of pursuing numerous divisional 
applications simultaneously. One comment also suggested that the need 
to file multiple stand alone applications or divisional applications at 
an early stage in prosecution to cover all embodiments of the invention 
will cause small companies to cut back funding on research in favor of 
patent prosecution, thus hindering innovation. One comment also 
suggested that the rules be revised, consistent with European Patent 
Office divisional practice, to permit the serial filing of divisional 
applications with the limitation that claims pursued in a continuation 
of any serial divisional application must be of the same scope as, or 
of a narrower scope than, the claims presented in that serial 
divisional application. One comment also suggested that prior to 
implementing the rule changes, the Office should conduct a study to 
assess the scope of potential divisional filing problems by studying 
the divisional filing habits of large and small entity applicants.
    Response: The Office notes the concerns expressed in the public 
comment regarding the proposed requirement in Sec.  1.78(d)(1)(ii) that 
a divisional application be filed during the pendency of the initial 
application. In response to those concerns and suggestions, Sec.  
1.78(d)(ii) as adopted in this final rule does not require that a 
divisional application be filed during the pendency of the initial 
application. This final rule permits applicants to file a divisional 
application for the claims to a non-elected invention if the initial 
application is subject to a requirement for restriction, the claims to 
the non-elected invention are cancelled in the initial application, and 
the divisional application meets the copendency requirement of 35 
U.S.C. 120. That is, an applicant may file a divisional application 
during the pendency of the application that was subject to a 
restriction requirement or the pendency of any continuing application 
of such application. This final rule also permits applicant to file two 
continuation applications of a divisional application, plus a request 
for continued examination in the divisional application family, without 
any justification.
    Comment 3: A number of comments suggested that the rule changes 
would encourage applicants to file more petitions challenging 
restriction requirements, thus further burdening the Office.
    Response: The criteria for making a restriction requirement remain 
the same. Applicant may still seek review of any restriction 
requirements, if appropriate. The Office, however, does not anticipate 
any substantial increase in the number of petitions seeking review of 
restriction requirements. As discussed previously, Sec.  1.78(d)(1)(ii) 
as adopted in this final rule does not require that a divisional 
application be filed during the pendency of a single prior-filed 
application. This final rule permits applicant to file a divisional 
application of an application if the application is subject to a 
requirement for restriction, claims to the non-elected invention are 
cancelled in the prior-filed application, and the divisional

[[Page 46746]]

application meets the copendency requirement of 35 U.S.C. 120. That is, 
applicant may file a divisional application during the pendency of the 
application that was subject to a requirement for restriction or the 
pendency of any continuing application of such application. Applicant 
will have sufficient time to determine whether to file a divisional 
application directed to a non-elected invention.
    Comment 4: Several comments stated that the rule changes do not 
adequately address the situation where a restriction requirement is 
made by the examiner in a continuing application. The comments 
expressed concern that the rule changes appear to require applicant to 
forego all but one invention. One comment stated that the applicant's 
prior application, if published, may constitute prior art if benefit to 
the prior application is not permitted. Another comment suggested that 
concerns over prolonging patent term, abuse or bad faith are not raised 
where a divisional application is filed as a result of a restriction 
requirement made in the continuing application, and that such filings 
may actually improve quality, as the searches performed in the initial 
and first continuing application often provide significant information 
and guidance to the examiner in the second continuing application.
    Response: As discussed previously, the Office has modified the 
proposed Sec.  1.78(d)(1)(ii) in this final rule such that it does not 
require a divisional application to be filed during the pendency of a 
single prior-filed application. Instead, this final rule permits an 
applicant to file a divisional application for the claims to a non-
elected invention that was not examined if the application was subject 
to a requirement for restriction, the claims to the non-elected 
invention are cancelled in the prior-filed application, and the 
divisional application meets the copending requirement of 35 U.S.C. 
120. Therefore, applicant may file a divisional application of a 
continuing application for the claims to a non-elected invention that 
has not been examined if the continuing application was subject to a 
requirement for restriction. Such a divisional application may claim 
the benefit of the continuing application that was subject to a 
requirement for restriction and the initial application whose benefit 
is claimed in the continuing application.
    Comment 5: One comment requested clarification as to whether a 
divisional application can be filed if a request for continued 
examination was filed in the initial application.
    Response: The filing of a request for continued examination in the 
initial application does not preclude an applicant from filing a 
divisional application under the proposed rule as well as under this 
final rule. The condition that ``no request for continued examination 
under Sec.  1.114 has been filed in the prior-filed application'' as 
proposed applied only to the filing of continuation and continuation-
in-part applications under proposed Sec.  1.78(d)(1)(i). Compare 
proposed Sec. Sec.  1.78(d)(1)(i) and 1.78(d)(1)(ii). Furthermore, 
Sec.  1.78(d)(1) as adopted in this final rule contains no conditions 
with respect to continuation applications, divisional applications, or 
continuation-in-part applications concerning whether a request for 
continued examination was filed in the initial application or a prior-
filed continuing application. Therefore, the filing of a request for 
continued examination does not preclude an applicant from filing two 
continuation or continuation-in-part applications, and any divisional 
application directed to a non-elected invention that has not been 
examined if the prior-filed application was subject to a requirement 
for restriction.
    Comment 6: A number of comments requested that the Office not limit 
``voluntary'' divisional applications. In addition, several comments 
noted the importance of ``voluntary'' divisional applications in 
protecting important inventions the significance of which could not 
reasonably be anticipated when the application was filed. Another 
comment indicated the importance of ``voluntary'' divisional 
applications for obtaining quick patents to protect applicants' 
products from competitors while preserving the opportunity to obtain 
patent protection on other aspects of the invention. Several comments 
stated that the standard under Sec.  1.78(d)(1) makes little sense when 
the objective of filing the continuing application is to obtain patents 
on distinct inventions. One of the comments expressed concern that each 
patent is, both by law and regulation, to be directed to a single 
invention and that patent applications directed to multiple inventions 
are subject to restriction under 35 U.S.C. 121.
    Response: This final rule permits applicants to file a so-called 
``voluntary'' divisional application as a continuation application in 
compliance with Sec.  1.78(d)(1)(i) when the prior-filed application 
was not subject to a requirement for restriction. Under Sec.  
1.78(d)(1)(i), applicant may file two such continuation applications 
without a petition and showing of why the amendment, argument, or 
evidence sought to be entered could not have been previously submitted. 
Applicant likewise may file a third or subsequent continuation 
application with a petition and showing pursuant to Sec.  
1.78(d)(1)(vi).
    Furthermore, applicant may suggest a requirement for restriction 
under Sec.  1.142(c) if the applicant believes that two or more 
independent and distinct inventions are claimed in the application. See 
Sec.  1.142(c) and the discussion of Sec.  1.142(c). In such case, 
Sec.  1.78(d)(1)(ii) provides that an applicant may file a divisional 
application directed to a non-elected invention that has not been 
examined if the prior-filed application is subject to a requirement for 
restriction. The divisional application is not required to be filed 
during the pendency of the application subject to a requirement for 
restriction, as long as the copendency requirement of 35 U.S.C. 120 is 
met. Section Sec.  1.78(d)(1)(iii) also permits an applicant to file, 
without a petition and showing, two continuation applications of a 
divisional application plus a request for continued examination in the 
divisional application family. Therefore, applicants have sufficient 
opportunity to obtain patent protection on other aspects of the 
invention.
    35 U.S.C. 121 provides that ``[i]f two or more independent and 
distinct inventions are claimed in one application, the Director may 
require the application to be restricted to one of the inventions.'' 
(Emphasis added.) Thus, 35 U.S.C. 121 authorizes, but does not compel, 
the Director to require that an application containing two or more 
independent and distinct inventions be restricted to one of the 
inventions. The Office typically decides whether to issue a restriction 
requirement when an application contains two or more independent and 
distinct inventions based upon, inter alia, the burden on the Office to 
search and examine more than one invention. See MPEP Sec.  803.
    Comment 7: Several comments suggested that the restriction on a so-
called ``voluntary'' divisional application would be a major divergence 
from other countries and would not be favorable from the viewpoint of 
promoting global harmonization of patent practices. One comment noted 
that the Japan Patent Office (JPO) and the European Patent Office (EPO) 
have liberal ``voluntary'' divisional application rules and have not 
reported any evidence of abuse.
    Response: Under this final rule, applicant still has the 
opportunity to file a so-called ``voluntary'' divisional application 
except that such an application is defined in this final rule

[[Page 46747]]

as a continuation application. That is, as discussed previously, 
applicant may file a ``voluntary'' divisional application as a 
continuation application in compliance with Sec.  1.78(d)(1)(i) when 
the prior-filed application was not subject to a requirement for 
restriction. Specifically, under Sec.  1.78(d)(1)(i), applicant may 
file two continuing applications of an initial application without a 
petition and showing and then may file a third or subsequent 
continuation with a petition and showing under Sec.  1.78(d)(1)(vi). 
Accordingly, this final rule is not a major divergence from the 
``voluntary'' divisional practice available in other countries.
    Moreover, under the PCT and the Paris Convention, the determination 
of the conditions and effect of internal (domestic) priority claims is 
a matter for the authority concerned. See, e.g., PCT Article 8(2)(b) 
and Article 4(G)(2) of the Paris Convention. Efforts in recent years to 
harmonize substantive patent law have not focused on achieving 
harmonization on domestic priority. (See http://www.wipo.int/patent/law/en/harmonization.htm for further information).
    Comment 8: Several comments suggested that eliminating 
``voluntary'' divisional applications violates Article 4G(2) of the 
Paris Convention.
    Response: Section 1.78(d) as adopted in this final rule does not 
eliminate what has traditionally been referred to as a ``voluntary'' 
divisional application. The second sentence of Article 4G(2) of the 
Paris Convention provides that each country ``shall have the right to 
determine the conditions under which such division shall be 
authorized.'' As discussed previously, a ``voluntary'' divisional 
application would not meet the definition of divisional application set 
forth in Sec.  1.78(a)(2), but would instead be a continuation 
application as defined in Sec.  1.78(a)(3). If the prior-filed 
application is not subject to a requirement for restriction, the 
applicant may file a ``voluntary'' divisional application as a 
continuation application under the conditions set forth in Sec.  
1.78(d)(1)(i). Such a definition is consistent with 35 U.S.C. 121. 
Furthermore, if the prior-filed application is subject to a requirement 
for restriction, Sec.  1.78(d)(1)(ii) provides that an applicant may 
file an ``involuntary'' divisional application directed to a non-
elected invention that has not been examined. Therefore, Sec.  1.78(d) 
is consistent with Article 4G(2) of the Paris Convention.
    Comment 9: One comment suggested amending proposed Sec.  
1.78(d)(1)(ii) to define a divisional application as an application 
that only includes claims that were non-elected in the prior-filed 
application to prevent new claims from being filed in the divisional 
application, thus further increasing the numbers of claims that 
examiners have to examine.
    Response: Such a requirement is unnecessary because applicant may 
amend the non-elected claims that have been filed in the divisional 
application during the course of prosecution of the divisional 
applications as the prior art is developed and/or to correct formal 
matters. Section Sec.  1.78(d)(1)(ii) as adopted in this final rule 
permits an applicant to file a divisional application directed to a 
non-elected invention that has not been examined that was subject to a 
requirement for restriction in the prior-filed application. Therefore, 
applicant may present claims in the divisional application that are 
different than the claims in the prior-filed application if the claims 
in the divisional application are directed to the subject matter of the 
non-elected invention.
    Comment 10: One comment expressed concern that the Office may 
pressure examiners to limit the issuance of restrictions in order to 
reduce the number of applications to be examined, thus artificially 
making it look like the pendency rate has gone down. The comment 
requested that the Office implement a policy mandating examiners to 
issue restrictions when requested by the applicant, except in cases 
where it is clear that such restrictions are not proper.
    Response: Restriction practice is set forth in Chapter 800 of the 
MPEP. As discussed previously, the applicant may suggest a requirement 
for restriction under Sec.  1.142(c) if the applicant believes that two 
or more independent and distinct inventions are claimed in the 
application. The examiner may accept or refuse the suggested 
restriction requirement. Alternatively, the examiner may issue a 
different restriction. See the discussion of Sec.  1.142(c). Either 
way, it remains important from the standpoint of the public interest 
that no requirements for restriction are made that might result in the 
issuance of two patents for the same invention. See MPEP Sec.  803.01.
    Comment 11: One comment questioned the status of a divisional 
application if the restriction requirement is withdrawn after filing of 
the divisional application.
    Response: If a restriction requirement is made and the applicant 
cancels the non-elected claims (and any generic claims or other types 
of linking claims if present) in the prior-filed application and files 
a divisional application, the restriction requirement will not be 
withdrawn. Also, as discussed previously, applicants cannot rely upon a 
requirement for restriction to avoid the requirement for an examination 
support document where: (1) The applicant traverses the requirement for 
restriction; (2) the requirement for restriction may be conditional, 
such as a requirement for election of species in an application that 
contains a claim that is generic to all of the claimed species (see 
MPEP Sec.  809), or a requirement for restriction in an application 
that contains a linking claim (e.g., a subcombination claim linking 
plural combinations); or (3) the applicant plans to request rejoinder 
of the claims to the non-elected invention (see MPEP Sec.  821.04 et 
seq.). Under Sec. Sec.  1.78(a)(2) and 1.78(d)(1)(ii), the prior-filed 
application to which a divisional application claims the benefit must 
be subject to a requirement to comply with the requirement of unity of 
invention under PCT Rule 13 or a requirement for restriction under 35 
U.S.C. 121 and the invention claimed in the divisional application must 
not have been elected for examination and must not have been examined 
in any prior-filed application. Thus, a divisional application will be 
improper when the claims to the non-elected invention have not been 
cancelled and the requirement for restriction is withdrawn in the 
prior-filed application (or when the invention claimed in the 
divisional application has been examined in the prior-filed 
application). Furthermore, since the claims of the prior-filed 
application and the divisional application would be drawn to the same 
invention, both applications may be subject to a double patenting 
rejection (see MPEP Sec.  821.04) and the provisions of 1.75(b)(4) 
(determining number of claims for purposes of examination support 
document threshold when multiple applications contain patentably 
indistinct claims).
    For example, where claims directed to a product and to a process of 
making and/or using the product are presented in the same application 
and subject to a requirement for restriction, the applicant may request 
rejoinder of the non-elected process claims that depend from or 
otherwise require all the limitations of an allowable product claim. 
See MPEP Sec.  821.04(b). Upon rejoinder of claims to a non-elected 
process invention, the requirement for restriction between the elected 
product and non-elected process invention is withdrawn. Thus, the 
rejoinder of non-elected process claims after allowance of the elected 
product claims may result in a prior or subsequently filed

[[Page 46748]]

``divisional'' application not being a proper divisional application 
under Sec. Sec.  1.78(a)(2) and 1.78(d)(1)(ii) because the prior-filed 
application is no longer subject to a requirement for restriction. 
Applicant may avoid this problem by canceling the non-elected process 
claims and claiming them in a divisional application before rejoinder 
occurs. In such a situation, because the non-elected claims have been 
cancelled, the restriction requirement cannot be withdrawn. This will 
preserve applicant's rights under 35 U.S.C. 121 and Sec.  
1.78(d)(1)(ii).
    If the applicant chooses to retain the non-elected claims and files 
a divisional application claiming the non-elected invention and then 
the restriction requirement is withdrawn in the prior-filed 
application, the benefit claim under Sec.  1.78(d)(1)(ii) in the later-
filed divisional application would no longer be proper. Thus, the 
later-filed application would not be entitled to the benefit of the 
prior-filed application. If applicant still desires to maintain the 
later-filed application, applicant must delete or correct the benefit 
claim to indicate that the application is a continuation application if 
the requirements set forth in Sec.  1.78(d)(1)(i) can be met. If 
applicant no longer wants to maintain the later-filed application, 
applicant may abandon the application before the examination has been 
made of the application and may request a refund of any previously paid 
search and excess claims fees.
    Comment 12: A number of comments suggested that limiting 
continuation-in-part applications was unnecessary. The comments 
explained that concerns associated with continually reopening 
prosecution do not apply to continuation-in-part applications, which 
are usually filed as a result of the inventor having developed a 
significant improvement in the invention. One comment stated that 
limiting continuation-in-part applications will not reduce application 
filings, but rather will simply cause applicants to file the 
application as a new application without a benefit claim because the 
claims of the continuation-in-part application are usually directed to 
the new subject matter and thus not entitled to benefit of the parent 
filing date. Several comments suggested that continuation-in-part 
applications are necessary for adequate protection of improvements to 
the invention and that these improvements often become the key feature 
of an invention that leads to its success. One comment, however, 
suggested that continuation-in-part practice be terminated, because 
with the twenty-year patent term, there is no benefit to applicant or 
to the Office associated with continuing this practice.
    Response: Inconsistent rules for continuation applications and 
continuation-in-part applications would likely lead to confusion and 
create the potential for abuse. First, there is no reason to treat 
continuation applications different from continuation-in-part 
applications where both fall under Sec.  1.78 and are contemplated by 
35 U.S.C. 120. Second, there is no reason why the Office should 
maintain the ability to file an unlimited string of continuation-in-
part applications without justification while proceeding with a change 
to Sec.  1.78 to require a justification for any third or subsequent 
continuation application. Third, if applicants could file continuation-
in-part applications without restriction, then they could be used as a 
tool to circumvent this final rule. Thus, the Office considers it 
appropriate to require a justification for any third or subsequent 
continuing application that is a continuation application or a 
continuation-in-part application.
    The changes in this final rule do not impact applicants' ability to 
protect improvements to the invention disclosed in a prior-filed 
application. Section 1.78(d)(1)(i) allows an applicant to file two 
continuation-in-part applications of a prior-filed application without 
a petition and showing. Applicant may also file any third or subsequent 
continuation-in-part application with a petition and showing. Hence, 
applicants have ample opportunity to seek protection for improvements.
    Furthermore, for the continuation-in-part application to actually 
receive the benefit of the filing date of the prior-filed application, 
35 U.S.C. 120 requires that the subject matter of at least one claim of 
the continuation-in-part application must be disclosed in the prior-
filed application in the manner provided by 35 U.S.C. 112, ] 1. See 
Studiengesellschaft Kohle m.b.H, 112 F.3d at 1564-65, 42 U.S.P.Q.2d at 
1677-78. The term of any patent resulting from the continuation-in-part 
application will be measured under 35 U.S.C. 154(a)(2) from the filing 
date of the prior-filed application, even if the continuation-in-part 
application never receives any benefit from the prior-filed 
application. See Abbott Labs., 104 F.3d at 1309, 41 U.S.P.Q.2d at 1537. 
To maximize the term of any resulting patent, applicant should file the 
application containing only claims directed to the improvements without 
claiming the benefit of the prior-filed application rather than a 
continuation-in-part application.
    Comment 13: Several comments suggested that, if the prior-filed 
application is abandoned in favor of a continuation-in-part application 
before examination of the prior-filed application, or is filed within a 
short time of the prior-filed application, the limits on continuing 
applications should not include such continuation-in-part applications. 
Several comments explained that in rapidly advancing sciences, 
continuation-in-part applications are often filed while abandoning the 
prior application in the chain before an examination of the merits. 
Thus, a continuation-in-part application is often the first in a series 
to be examined as an initial application. At a minimum, the rules 
should be modified to exclude from counting prior-filed applications 
that are abandoned before issuance of a first action on the merits.
    Response: Section 1.78(d)(1)(v) as adopted in this final rule 
addresses the situation in which an applicant files a continuation (or 
continuation-in-part) application to correct informalities rather than 
completing an application for examination under Sec.  1.53. Under Sec.  
1.78(d)(1)(v), if the prior-filed application is abandoned due to the 
failure to timely reply to an Office notice issued under Sec.  
1.53(f)), the applicant may file ``one more'' continuation application 
(or continuation-in-part application) without there being a requirement 
for a petition and showing under Sec.  1.78(d)(1)(vi). Specifically, 
Sec.  1.78(d)(1)(v) provides that a continuation application or 
continuation-in-part application is permitted if the following 
conditions are met: (1) The application claims benefit under 35 U.S.C. 
120 or 365(c) of a prior-filed nonprovisional application filed under 
35 U.S.C. 111(a), and the prior-filed nonprovisional application became 
abandoned due to the failure to timely reply to an Office notice issued 
under Sec.  1.53(f) and does not claim the benefit of any other 
nonprovisional application or international application designating the 
United States of America; (2) the application is a continuation 
application as defined in Sec.  1.78(a)(3) or a continuation-in-part 
application as defined in Sec.  1.78(a)(4) that claims the benefit 
under 35 U.S.C. 120, 121, or 365(c) of no more than three prior-filed 
applications; and (3) any application whose benefit is claimed under 35 
U.S.C. 120, 121, or 365(c) in such nonprovisional application has its 
benefit claimed in no more than two other nonprovisional applications. 
This does not include any divisional

[[Page 46749]]

application that satisfies the conditions set forth in Sec.  
1.78(d)(1)(ii) or continuation application that claims the benefit of 
such divisional application and satisfies the conditions set forth in 
Sec.  1.78(d)(1)(iii).
    For example, applicant may file a third continuation (or 
continuation-in-part) application claiming the benefit of an 
intervening (second) continuation (or continuation-in-part) 
application, a first continuation (or continuation-in-part) 
application, and a prior-filed application without a petition under 
Sec.  1.78(d)(1)(vi), if the prior-filed application became abandoned 
due to the failure to timely reply to a Notice to File Missing Parts 
mailed by the Office of Initial Patent Examination and does not claim 
the benefit of any other application. The prior-filed application, 
however, must be entitled to a filing date and have paid therein the 
basic filing fee within the pendency of the application. See Sec.  
1.78(d)(2).
    Comment 14: One comment suggested that the rule changes encourage 
applicants to file two applications, i.e., a continuation-in-part 
application and a divisional application, rather than a single 
continuation-in-part application, where the non-elected invention is 
further developed. The comment stated that this is inefficient for both 
the Office and applicants.
    Response: The Office appreciates that the changes being adopted in 
this final rule do provide some incentive for applicants who seek only 
to maximize the number of continuing applications and requests for 
continued examination permitted without any justification to file both 
a continuation-in-part application and a divisional application in this 
situation. However, applicants seeking to maximize the number of 
continued examination filings are not likely to file only a single 
continuation-in-part application in this situation under either the 
former practice or the change to continuing application practice being 
adopted in this final rule. Furthermore, this final rule permits 
applicant to file two continuation or continuation-in-part applications 
plus one request for continued examination in an application family, 
without any justification. And, this final rule permits applicant to 
file two continuation applications plus one request for continued 
examination in the divisional application family, without any 
justification.
    Comment 15: One comment suggested that continuation-in-part 
applications are an important tool for correcting errors in the initial 
application (e.g., correction of test data) and this should be 
encouraged, rather than discouraged.
    Response: The Office is neither encouraging nor discouraging the 
filing of continuation-in-part applications. Rather, this final rule 
treats continuation-in-part applications roughly the same as 
continuation applications. That is, applicant is permitted to file two 
continuation or continuation-in-part applications of an initial 
application without a petition and showing. Applicant is also permitted 
to file a third or subsequent continuation or continuation-in-part 
application with a petition and showing. See Sec.  1.78(d)(1)(i). The 
only notable difference between the two, apart from their definitions, 
is that an applicant may file only a continuation application of a 
divisional application and not a continuation-in-part application of a 
divisional application. See Sec.  1.78(d)(1)(iii). Nevertheless, 
applicants may use continuation-in-part applications to correct initial 
applications under this final rule to the extent they were used for 
this purpose before this final rule. Furthermore, as previously 
discussed, Sec.  1.78(d)(1)(v) as adopted in this final rule provides 
that if an applicant files a continuation (or continuation-in-part) 
application to correct informalities rather than completing an 
application for examination under Sec.  1.53, the applicant may file 
``one more'' continuation application (or continuation-in-part 
application) without there being a requirement for a petition and 
showing under Sec.  1.78(d)(1)(vi). See Sec.  1.78(d)(1)(v).
    Comment 16: One comment suggested that the Office should require 
applicants to certify that no 35 U.S.C. 102(b) bar applies for 
continuation-in-part applications filed more than twelve months from 
the earliest claimed date.
    Response: Under Sec.  1.56, applicant has a duty to disclose to the 
Office all information known to applicant to be material to 
patentability including any prior art under 35 U.S.C. 102(b). This 
includes a reference with a publication date more than one year prior 
to the filing date of the continuation-in-part application if at least 
one claim in the continuation-in-part application is drawn to the 
subject matter not disclosed in the prior-filed application. Applicant 
is required to file a newly executed oath or declaration under Sec.  
1.63 upon the filing of a continuation-in-part application. See Sec.  
1.63(e). The oath or declaration under Sec.  1.63 must include a 
statement that the person making the oath or declaration acknowledges 
the duty to disclose to the Office all information known to the person 
to be material to patentability as defined in Sec.  1.56. See Sec.  
1.63(b)(3).
    Comment 17: One comment argued that requiring applicant to identify 
whether the claims are supported by the specification before the 
examination is unfair and unreasonable because it is a legal issue that 
should be determined during the prosecution. Another comment suggested 
that the Office should, at most, require applicant to identify the 
differences between the continuation-in-part application and the prior-
filed application. Another comment suggested that when a continuation-
in-part application is filed, the Office should require the applicant 
to discuss whether the new matter added to the specification is 
inventive or based on ordinary skill. One comment, however, supported 
the requirement for a continuation-in-part applicant to identify which 
claims are disclosed in the prior-filed application and thus are 
entitled to the earlier filing date.
    Response: Applicants are in the best position to identify the 
effective filing date of their claims. Thus, Sec.  1.78(d)(3) provides 
that if an application is identified as a continuation-in-part 
application, the applicant must identify the claim or claims for which 
the subject matter is disclosed in the manner provided by 35 U.S.C. 
112, ] 1, in the prior-filed application. Any claim that is not so 
identified will be treated as only being entitled to the actual filing 
date of the continuation-in-part application, and subjected to prior 
art based on the actual filing date of the continuation-in-part 
application.
    Whether any ``new matter'' is inventive or based on ordinary skill 
is not determinative of whether the claims of the continuation-in-part 
application are entitled to the filing date of the prior-filed 
application. The test is whether the original disclosure of the prior-
filed application provides adequate support and enablement for the 
claimed subject matter of the continuation-in-part application in 
compliance with the requirement of 35 U.S.C. 112, ] 1. See MPEP Sec.  
201.11, I, Disclosure Requirement.
    Comment 18: A number of comments suggested that the rule changes 
effectively eliminate the use of ``bypass'' continuing applications 
(i.e., an application filed under 35 U.S.C. 111(a) that claims benefit 
under 35 U.S.C. 120 or 365(c) of the filing date of an earlier 
international application that did not enter the national stage under 
35 U.S.C. 371). The comments argued that a bypass continuing 
application would be counted as a continuing application whereas a 
national stage submission under 35 U.S.C. 371 would not. The comments 
indicated that there are

[[Page 46750]]

important reasons for filing bypass applications and suggested that it 
is unfair to treat bypass applications differently than national stage 
applications because in both applications the examiner will be 
examining the claims for compliance with U.S. national law for the 
first time. Consequently, a number of comments recommended that the 
international application should not be counted toward the threshold 
for filing continuing applications unless the international application 
enters the U.S. national stage, while other comments recommended that 
the bypass application should not be counted.
    Response: The Office notes the concerns expressed in the public 
comment regarding the proposed changes to Sec.  1.78(d)(1). The Office 
has modified proposed Sec.  1.78(d)(1) in this final rule to provide 
for certain ``bypass'' continuing applications. Under Sec.  
1.78(d)(1)(iv), if a Demand has not been filed and the basic national 
fee has not been paid in the international application, and the 
international application does not claim the benefit of any other 
nonprovisional application or international application designating the 
United States of America, the applicant may file ``one more'' 
continuation application (or continuation-in-part application) of such 
international application without there being a requirement for a 
petition and showing under Sec.  1.78(d)(1)(vi). Specifically, Sec.  
1.78(d)(1)(iv) provides that a continuation application or 
continuation-in-part application is permitted if the following 
conditions are met: (1) The application claims benefit under 35 U.S.C. 
120 or 365(c) of a prior-filed international application designating 
the United States of America, and a Demand has not been filed and the 
basic national fee (Sec.  1.492(a)) has not been paid in the prior-
filed international application and the prior-filed international 
application does not claim the benefit of any other nonprovisional 
application or international application designating the United States 
of America; (2) the application is either a continuation application as 
defined in Sec.  1.78(a)(3) or a continuation-in-part application as 
defined in Sec.  1.78(a)(4) that claims the benefit under 35 U.S.C. 
120, 121, or 365(c) of no more than three (rather than two) prior-filed 
applications; and (3) any application whose benefit is claimed under 35 
U.S.C. 120, 121, or 365(c) in such nonprovisional application has its 
benefit claimed in no more than two (rather than one) other 
nonprovisional applications. This does not include any divisional 
application that satisfies the conditions set forth in Sec.  
1.78(d)(1)(ii) or continuation application that claims the benefit of 
such divisional application and satisfies the conditions set forth in 
Sec.  1.78(d)(1)(iii).
    For example, applicant may file a third continuation application 
claiming the benefit of an intervening (second) continuation (or 
continuation-in-part) application, the first ``bypass'' continuation 
(or continuation-in-part) application, and the prior-filed 
international application without a petition under Sec.  
1.78(d)(1)(vi), if a Demand has not been filed and the basic national 
fee has not been paid in the international application, and the 
international application does not claim the benefit of any other 
nonprovisional application or international application designating the 
United States of America.
    Comment 19: Several comments questioned whether an international 
application that designates the United States of America and claims 
benefit to a prior nonprovisional application would be treated as a 
second continuation application upon entry into the U.S. national stage 
if a request for continued examination is filed in the nonprovisional 
application prior to entering the national stage. Another comment 
questioned whether a request for continued examination could be filed 
in a nonprovisional application if a U.S. national stage application 
claims benefit under 35 U.S.C. 120 or 365(c) to the nonprovisional 
application. Several comments suggested that if an international 
application designating the United States of America claims benefit to 
a prior-filed nonprovisional application, and a request for continued 
examination is filed in the nonprovisional application, then a petition 
under Sec.  1.78(d)(1)(vi) would be required, in violation of PCT Rule 
51bis, in order to perfect entry of the international application into 
the U.S. national stage. The comments also suggested that any refusal 
to grant such a petition would violate the PCT because there is no 
basis in the treaty for refusing national stage perfection on such 
grounds.
    Response: The Office notes the concerns expressed in the public 
comment regarding the proposed changes to Sec. Sec.  1.78(d)(1) and 
1.114 that would permit an applicant to file only one of the following: 
A continuation application, a continuation-in-part application, or a 
request for continued examination, without any justification. The 
Office has made modifications to these proposed changes such that this 
final rule permits an applicant to file two continuation applications 
or continuation-in-part applications, plus a single request for 
continued examination in an application family, without any 
justification. Therefore, under this final rule, applicant is permitted 
to have the national stage of an international application designating 
the United States of America claim the benefit of a prior-filed 
nonprovisional application in which a request for continued examination 
has been filed without a petition and showing. The provisions of Sec.  
1.78(d)(1) are independent of the provisions of Sec.  1.114. The filing 
of a request for continued examination in a nonprovisional application 
does not preclude a U.S. national stage application from claiming the 
benefit of the nonprovisional application. Likewise, a U.S. national 
stage application claiming the benefit under 35 U.S.C. 120 or 365(c) of 
a nonprovisional application will not preclude an applicant from filing 
a request for continued examination in the nonprovisional application.
    Applicant may also file any additional continuation or 
continuation-in-part application or request for continued examination 
with a petition and showing. If an international application that 
enters the U.S. national stage contains or is amended to contain a 
specific reference to a prior-filed application that is not permitted 
by at least one of Sec. Sec.  1.78(d)(1)(i) through (d)(1)(vi), the 
Office will refuse to enter, or will delete if present, the specific 
reference to the prior-filed application. See Sec.  1.78(d)(1). 
Furthermore, the national stage application will be treated as entitled 
only to the actual international filing date of the national stage 
application, and will be subject to prior art based on the actual 
international filing date.
    Refusal to grant a petition under Sec.  1.78(d)(1)(vi) (assuming 
such a petition is necessary) would not prevent an applicant from 
completing the requirements for entry into the national phase under 35 
U.S.C. 371. The requirements for entry of an international application 
into the national phase under 35 U.S.C. 371 are set forth in 35 U.S.C. 
371(c) and Sec.  1.495. The effect of a refusal to grant any such 
petition would only be that the national stage application would not be 
entitled to the benefit of the filing date of the nonprovisional 
application under 35 U.S.C. 120 and 365(c). Furthermore, the necessity 
to file a petition under Sec.  1.78(d)(1)(vi) in the national stage 
application to obtain benefit to the nonprovisional application would 
not

[[Page 46751]]

violate PCT Rule 51bis. PCT Rule 51bis does not govern the requirements 
that a designated Office may impose for recognition of domestic benefit 
claims. Rather, the ability of a designated Office to establish 
conditions for, and the effect of, domestic benefit claims is expressly 
provided for in PCT Article 8(2). PCT Article 8(2) states, in pertinent 
part, that ``[w]here, in the international application, the priority of 
one or more national applications filed in or for a designated State is 
claimed, or where the priority of an international application having 
designated only one State is claimed, the conditions for, and the 
effect of, the priority claim in that State shall be governed by the 
national law of that State.''
    Comment 20: Several comments suggested that the rules create an 
anomaly. The comments argued that if an application is first filed as a 
nonprovisional application followed by an international application 
claiming benefit to the nonprovisional application, and a request for 
continued examination is subsequently filed in the nonprovisional 
application, then a petition under Sec.  1.78(d)(1)(vi) would be needed 
when the international application enters the U.S. national phase. The 
comments, however, further argued that if the application is first 
filed as a provisional application followed by, one year later, 
concurrently filed international and nonprovisional applications both 
claiming benefit to the provisional application, then a petition under 
Sec.  1.78(d)(1)(vi) would not be needed when the international 
application enters the U.S. national phase even if a request for 
continued examination was filed in the nonprovisional application.
    Response: The Office has made modifications to the proposed changes 
to Sec. Sec.  1.78(d)(1) and 1.114 such that this final rule permits an 
applicant to file two continuation applications or continuation-in-part 
applications, plus a single request for continued examination in an 
application family, without any justification. Therefore, under this 
final rule, applicant may enter the U.S. national stage in an 
international application designating the United States of America 
claiming the benefit of a prior-filed nonprovisional application in 
which a request for continued examination has been filed without a 
petition and showing. As discussed previously, the provisions of Sec.  
1.78(d)(1) are independent of the provisions of Sec.  1.114. The filing 
of a request for continued examination in a nonprovisional application 
does not preclude a U.S. national stage application from claiming the 
benefit of the nonprovisional application.
    Note that, in the first described application chain, the 
international application claims benefit to a nonprovisional 
application under 35 U.S.C. 120 or 365(c) and therefore is a 
``continuing application'' as defined in Sec.  1.78(a). In the second 
described application chain, the international application is not a 
continuing application as it only claims benefit to the provisional 
application. In any event, Sec.  1.78(d)(1) as adopted in this final 
rule would not require a petition and showing for the national stage 
application to claim the benefit of a prior-filed application in which 
a request for continued examination has been filed.
    Comment 21: One comment argued that applicants who first file a 
nonprovisional application followed by a continuation-in-part 
application would not be able to designate the United States in any 
subsequently filed international application without a showing as to 
why the international application could not have been filed earlier. 
The comment argued that this violates the PCT.
    Response: The Office has made modifications to the proposed changes 
to Sec.  1.78(d)(1) such that this final rule permits an applicant to 
file two continuation applications or continuation-in-part 
applications, plus a single request for continued examination in an 
application family, without any justification. Therefore, under this 
final rule, applicant may file an international application designating 
the United States of America claiming the benefit of two prior-filed 
nonprovisional applications without a petition and showing. Applicant 
may also file any additional continuation or continuation-in-part 
application or request for continued examination with a petition and 
showing. The petition procedure under Sec.  1.78(d)(1)(vi) applies only 
to international applications that have entered the U.S. national stage 
after compliance with 35 U.S.C. 371. Thus, the rule neither requires 
nor provides for the submission of such petitions in international 
applications during the international phase. It is also noted that 
under PCT Rule 4.9, the designation of all states, including the United 
States of America, in international applications is automatic upon 
filing of the PCT request.
    Comment 22: Several comments questioned whether the limitation on 
the examination of claims in nonprovisional applications under Sec.  
1.75(b) could be circumvented by first filing an international 
application with as many claims as desired and then entering the U.S. 
national phase after the claims have been searched in the international 
phase. The comments suggested that the Office should examine all claims 
in a national stage application that were the subject of a search and 
written opinion in the international phase, particularly if the United 
States Patent and Trademark Office was the international searching 
authority.
    Response: The requirements of Sec.  1.75(b) apply to national stage 
applications under 35 U.S.C. 371 as well as to applications filed under 
35 U.S.C. 111(a). Thus, the rule cannot be circumvented by utilizing 
the PCT route. The fact that more than five independent claims or more 
than twenty-five total claims may have been searched and even subjected 
to international preliminary examination in the international phase 
will not entitle applicants to more than five independent claims or 
more than twenty-five total claims in the U.S. national phase 
application without the submission of an examination support document. 
This is analogous to existing practice under Sec.  1.499, which permits 
restriction of claims in a national stage application for lack of unity 
notwithstanding that such claims may have been searched and subject to 
international preliminary examination in the international phase. 
Applying Sec.  1.75(b) to national stage applications is appropriate 
because prior art uncovered during the international search often 
necessitates the need to make substantial amendments to the claims in 
the national phase. Additionally, the claims would need to be examined 
for compliance with all substantive requirements of U.S. national law.
    Comment 23: One comment suggested that the rules limiting 
continuing applications would result in more applicants filing 
international applications and entering the U.S. national stage in 
order to avoid onerous restriction requirements. Another comment 
suggested that the rules limiting the examination of claims might 
trigger increased usage of the PCT and national stage entry into the 
U.S.
    Response: Applicants are free to choose whichever route they 
believe is more advantageous for obtaining patent protection in the 
United States, whether through the PCT or through a direct national 
filing under 35 U.S.C. 111(a).
    Comment 24: A number of comments requested that the Office should 
notify the applicant in an Office action when a continuing application 
is not available under any one of the first three conditions in Sec.  
1.78(d)(1). A number of

[[Page 46752]]

comments stated that the refusal to enter or to delete any references 
to prior-filed applications that are not permitted under Sec.  
1.78(d)(1) would place a heavy burden on the Office.
    Response: The changes to Sec. Sec.  1.78 and 1.114 in this final 
rule are clearly set forth in this final rule. Applicant and his or her 
representative have the duty to know the rules of practice when 
prosecuting an application for patent before the Office. Applicant 
should not file a continuing application without knowing whether it is 
proper. The refusal to enter or to delete any references to prior-filed 
applications that are not permitted under Sec.  1.78(d)(1) would not 
place any additional burden on the Office.
    Comment 25: A number of comments argued that the rule changes would 
protract the examination process and divert resources from examining 
functions to administrative tasks. In particular, the comments 
predicted that the rule changes would increase the number of petitions, 
including petitions for filing additional continuing applications and 
requests for continued examination and petitions for supervisory review 
of Office actions and restriction requirements. Several other comments 
argued that the delay in prosecution of an application would increase 
while decisions on petitions under Sec. Sec.  1.78(d)(1)(vi) and 
1.114(g) were debated and reviewed. Several comments questioned whether 
the Office would be adequately staffed with enough personnel to handle 
the onslaught of petitions, as well as further review of decisions 
dismissing the petitions. Several comments also argued that any 
reduction in backlog would be insignificant given that the Office would 
grant some of the petitions for additional continuing applications and 
requests for continued examination. Several comments suggested that the 
proposed changes to the continued examination practice will force 
applicants to petition every improper procedural requirement by 
examiners, including restriction requirements, finality and non-entry 
of after-final amendments, in order to preserve applicant's rights. One 
comment stated that applicants are likely to file petitions, such as 
petitions addressing the prematureness of a final rejection under Sec.  
1.181, to save their one ``as-matter-of-right'' continuation or 
continuation-in-part application or request for continued examination. 
Several comments stated that applicants would petition almost all 
restriction requirements, resulting in an increase in the number of 
petitions filed. Another comment stated petitions seeking review of 
restriction requirements would be filed in order to determine early in 
the prosecution cycle the number of divisional applications that must 
be filed to preserve patent rights.
    Response: One of the Office's goals is to focus its limited patent 
examining resources on the examination of new applications, and thereby 
increase the effectiveness of Office resources while also reducing the 
backlog of unexamined patent applications. The requirements for seeking 
third and subsequent continuing applications will not have an effect on 
the vast majority of patent applications. The changes being adopted in 
this final rule, however, will reduce the strain on the Office's patent 
examining resources, which will allow for a better, more timely 
examination of new applications.
    The Office recognizes the amount and type of resources needed to 
implement the changes to Sec. Sec.  1.78 and 1.114 being adopted in 
this final rule. The authority to decide petitions under Sec. Sec.  
1.78(d)(1)(vi) and 1.114(g) has been delegated to the Deputy 
Commissioner for Patent Examination Policy (who may further delegate 
this authority to officials under the Deputy Commissioner for Patent 
Examination Policy). The Office is planning to provide sufficient staff 
to handle the projected number of petitions.
    The Office provides the procedure under Sec.  1.181 for applicants 
to seek review of requirements and objections made by the examiner. If 
applicant finds that a requirement or an objection made in an Office 
action is procedurally wrong, applicant should request reconsideration 
or file a petition under Sec.  1.181 to review the requirement or 
objection. As an example, when applicant challenges the finality of an 
Office action as being premature, the applicant should focus on whether 
the Office action met the appropriate standard for finality. The Office 
will make every effort to decide the petitions in a timely manner. 
Applicant, however, should not file a continuing application or a 
request for continued examination in an effort to address improper 
procedural requirements. Petitions for supervisory review of Office 
actions and restriction requirements will continue to be decided by 
supervisory patent examiners or other managers. Therefore, examiners 
will not be diverted from the examination process by these petitions. 
Finally, it should be noted that complaints about an Office action that 
relate to the merits of patentability of the claims must be addressed 
in an appeal to the BPAI, and not in a petition under Sec.  1.181 for 
supervisory review, even if the issues may be phrased in procedural 
terms. See Boundy v. U.S. Pat. & Trademark Office, 73 U.S.P.Q. 2d 1468, 
1472 (E.D. Va. 2004).
    Comment 26: Several comments stated that any resources saved via 
implementation of these final rules would be used for other filings 
necessitated by the changes. Thus the rule changes, according to the 
comments, would increase the backlog and pendency and add to the 
administrative cost and burdens of the Office. In particular, a number 
of comments predicted that the number of applications would increase 
because applicants would file more of the following: (1) Provisional 
applications; (2) continuation applications rather than requests for 
continued examination; (3) reissue applications to perfect or broaden 
claims; (4) reexamination proceedings to have prior art considered; (5) 
divisional applications (because applicants are required to file all 
divisional applications during the pendency of the first application); 
(6) multiple parallel applications that have similar or the same 
disclosures; and (7) continuing applications before the effective date.
    Response: The Office notes the concerns expressed in the public 
comment and has attempted to avoid the possibility of increased filings 
necessitated by modifying the proposed changes. The Office has made 
modifications to the proposed changes to Sec. Sec.  1.78(d)(1) and 
1.114 such that this final rule permits an applicant to file two 
continuation applications or continuation-in-part applications, plus a 
single request for continued examination in an application family, 
without any justification. Also, under this final rule, a divisional 
application need not be filed during the pendency of the application 
subject to a requirement for restriction, as long as the copendency 
requirement of 35 U.S.C. 120 is met. This final rule also permits 
applicant to file two continuation applications of a divisional 
application plus a request for continued examination in the divisional 
application family, without any justification. Therefore, the Office 
does not expect any significant increase in filings of applications. 
Specifically, the Office does not expect that the number of divisional 
applications would increase in response to the changes being adopted in 
this final rule because applicants should have sufficient time to 
determine whether to file a divisional application for a non-elected 
invention following a restriction requirement. Furthermore, an increase 
in filings of provisional applications will not place additional burden 
on the Office's patent

[[Page 46753]]

examining resources because no examination is provided in provisional 
applications. The Office does not expect its examining resources to be 
impacted when applicants file continuation applications rather than 
requests for continued examination, or when applicants file reissue 
applications and reexamination proceedings rather than continuing 
applications.
    The changes being adopted in this final rule do not encourage 
applicants to file multiple applications with patentably indistinct 
claims. Pursuant to Sec.  1.78(f)(3), the Office may require 
elimination of the patentably indistinct claims from all but one of the 
nonprovisional applications. If the patentably indistinct claims are 
not eliminated from all but one of the applications, the Office will 
treat each application as having the total of all of the claims 
(whether in independent or dependent form) for purposes of determining 
whether an examination support document is required by Sec.  1.75(b). 
See Sec.  1.75(b)(4). Moreover, when an applicant (or assignee) files 
multiple applications with the same claimed filing or priority date, a 
common inventor, and substantial overlapping disclosures, the Office 
will presume that the applications contain patentably indistinct 
claims. See Sec.  1.78(f)(2). The applicant must either rebut this 
presumption or submit the appropriate terminal disclaimers and explain 
why two or more pending applications containing patentably indistinct 
claims should be maintained. Once applicant recognizes that having 
multiple applications that contain patentably indistinct claims is not 
needed, applicant would abandon the applications or stop filing 
multiple applications that have patentably indistinct claims.
    Comment 27: One comment stated that a requirement for Director's 
approval to file a second or subsequent continuing application or 
request for continued examination would create a disincentive for 
examiners to provide a thorough examination, leaving the burden on the 
applicant to prosecute the application.
    Response: The Office modified the proposed provision that would 
have limited applicant to one continuation or continuation-in-part 
application or to one request for continued examination, without any 
justification. This final rule allows applicant to file two 
continuation or continuation-in-part applications plus a request for 
continued examination in an application family, without any 
justification. What is more, the Office expects that limiting the 
number of continuing applications and requests for continued 
examination that may be filed without justification will encourage both 
applicants and examiners to engage in a more thorough prosecution and 
examination earlier in the application process. Examiners are 
professionals who perform their duties in compliance with patent laws, 
rules of practice, and patent examining procedures set forth in the 
MPEP. They are responsible for the quality of their work product. There 
is no reason why examiners would provide lower quality examination in 
response to the changes in this final rule. In fact, this final rule is 
intended to improve the quality of examination by facilitating the 
examination of applications that contain more than five independent 
claims or twenty-five total claims via the examination support 
document.
    Comment 28: A number of comments stated that the Office should 
treat continuing applications the same as new applications and should 
not limit the available protection because applicants who file 
continuing applications pay the same filing fees as those who file a 
new application. One comment argued that continuing applications should 
not be limited because they claim ``new inventions'' in that they 
pursue broader claims, a different invention, or an improvement, and 
the purpose of patents is to protect inventions, not to facilitate 
examination. One comment argued that continuation and continuation-in-
part applications are legitimate because the statutes that create and 
authorize ``continuation practice'' do not distinguish such 
applications from ``new'' applications in terms of their importance, 
nor do they limit the resources that are committed to them.
    Response: The former unrestricted continued examination practice 
was impairing the Office's ability to examine new applications. As a 
result, the Office is modifying continued examination practice in this 
final rule to address the backlog of unexamined new applications. Under 
this final rule, therefore, if the amendments, arguments, or evidence 
sought to be entered could have been previously submitted in the 
initial application, two continuing applications, and a request for 
continued examination, applicants are encouraged to make such 
submissions early rather than wait to do so in another continuing 
application or request for continued examination. That way, the 
examiner would have the information earlier to make the patentability 
determination. If applicant could not have submitted them earlier, 
applicant may file a third continuing application with a petition and 
showing under Sec.  1.78(d)(1)(vi) or a second request for continued 
examination with a petition and showing under Sec.  1.114(g).
    Comment 29: A number of comments stated that the rule changes would 
not permit applicants to file even a single continuation or 
continuation-in-part application, when the applicant filed a request 
for continued examination in the initial application.
    Response: The Office has made modifications to the proposed changes 
to Sec. Sec.  1.78(d)(1) and 1.114 such that this final rule permits an 
applicant to file two continuation applications or continuation-in-part 
applications, plus a single request for continued examination in an 
application family, without any justification. Applicant may also file 
any additional continuation or continuation-in-part application or 
request for continued examination with a petition and showing as to why 
the amendment, argument, or evidence sought to be entered could not 
have been submitted earlier. The provisions of Sec.  1.78(d)(1) are 
independent of the provisions of Sec.  1.114. The filing of a request 
for continued examination in the initial application does not preclude 
applicant from filing a continuing application of the initial 
application.
    Comment 30: Several comments objected to the Office's proposal that 
a petition under Sec.  1.78 to accept an unintentionally delayed claim 
under 35 U.S.C. 120, 121, or 365(c) will not be granted in an 
application in which a request for continued examination has been 
filed. One comment argued that applicant would lose substantial rights 
if the Office dismisses a petition to accept an unintentionally delayed 
claim filed after a request for continued examination has been filed in 
the prior-filed application.
    Response: The Office has made modifications to the proposed changes 
to Sec. Sec.  1.78 and 1.114 such that the provisions of Sec.  1.78(d) 
as adopted in this final rule are independent of the provisions of 
Sec.  1.114. Thus, Sec.  1.78(e) as adopted in this final rule does not 
provide that a petition to accept an unintentionally delayed claim 
under 35 U.S.C. 120, 121, or 365(c) will not be granted in an 
application in which a request for continued examination has been 
filed.
    Comment 31: A number of comments stated that the rule changes would 
not permit applicants to consolidate two applications into a single 
continuation-in-part application, which is contrary to the goal of 
reducing the number of applications.

[[Page 46754]]

    Response: The Office has made modifications to the proposed changes 
such that this final rule permits an applicant to file two continuation 
applications or continuation-in-part applications, plus a single 
request for continued examination in an application family, without any 
justification. Therefore, applicant is permitted to file a 
continuation-in-part application that claims the benefit of two prior-
filed applications without a petition and showing under Sec.  
1.78(d)(1)(vi). If applicant thinks that a third or subsequent 
continuation-in-part application is necessary for consolidation 
purposes, then such applicant may file a petition and showing under 
Sec.  1.78(d)(1)(vi) to obtain the additional filing.
    Comment 32: Several comments argued that applicants need continuing 
applications and requests for continued examination because the reissue 
procedure does not give applicants the same flexibility.
    Response: Continuing applications and requests for continued 
examination are not, by statute, available for the same purposes as 
reissue applications. Continuing applications and requests for 
continued examination are available to an applicant during the 
prosecution of an initial application to enable an applicant to secure 
protection on the full scope of an invention with the correct benefit 
claim. See 35 U.S.C. 120, 121, and 365(c). By contrast, the reissue 
procedure is available to an applicant after a patent has issued to 
permit an applicant to correct errors made during the prosecution of 
the original application without any deceptive intention and to enlarge 
the scope of the claims of the original patent if the reissue 
application is filed within two years from the grant of the original 
patent. See 35 U.S.C. 252. Furthermore, this final rule permits 
applicant to file two continuation or continuation-in-part applications 
plus one request for continued examination in an application family, 
without any justification. These available filings provide sufficient 
flexibility.
    Comment 33: One comment suggested that the rule changes would be 
contrary to patent harmonization goals. One comment argued that the 
rule changes would hurt foreign applicants because they would be 
required to assess the degree of protection much earlier than they 
normally would, resulting in retaliatory challenges abroad for U.S. 
applicants.
    Response: The Office did not receive any comments from any foreign 
patent office or authority. The Office does not expect any retaliation 
from other countries or any adverse impact. Many countries do not have 
flexible practices for filing continuation applications, continuation-
in-part applications, and requests for continued examination.
    Comment 34: A number of comments argued that the rule changes would 
increase the cost to applicants for prosecuting each application, and 
for filing more multiple parallel applications, divisional 
applications, appeals, and petitions under Sec. Sec.  1.78 and 1.114. 
Several comments argued that the rule changes would cause applicants to 
incur excessive expenses before determining whether the invention is 
commercially viable. One comment argued that the Office would cause 
applicants to perform patent searches in order to have a good working 
knowledge of the prior art to draft claims for full coverage. One 
comment argued that the rule changes would increase practitioner fees 
because applicants must submit more carefully drafted claims and 
replies (estimated five additional hours per case for drafting all 
possible claims, at an average of 150 dollars per hour, the additional 
cost would be 750 dollars per application or 200 million dollars for 
317,000 applications). One comment estimated that the attorney cost in 
preparing an application would at least double if not increase by a 
factor of ten, which would place new applications out of reach of small 
businesses. Several comments argued that it would be practically 
impossible or at least much more difficult, expensive and time-
consuming to obtain patent protection for the full scope of inventions, 
especially for large, complex inventions. One comment argued that the 
rule changes are extremely burdensome for patent applicants and 
practitioners to maintain and develop a cohesive patent strategy. One 
comment stated that the rule changes were very complex and fraught with 
ambiguity and would create difficulties and misunderstandings for 
applicants and practitioners in the implementation, possibly resulting 
in the loss of inventors' rights and an increase in practitioners' 
exposure to malpractice.
    Response: The Office encourages applicants to diligently prosecute 
the initial application, two continuation or continuation-in-part 
applications, and one request for continued examination, without a 
petition and showing, so that applicants do not need to file a petition 
and showing to secure a third or subsequent continuation or 
continuation-in-part application or a second or subsequent request for 
continued examination and incur the costs associated with these 
filings. The patent system best serves the interests of all parties, 
including the public, when applicants and their representatives are 
diligent in drafting the claims and replies. Applicant would get a 
quality patent with desirable claim coverage. The Office would not 
waste patent examining resources to examine applications that are not 
diligently prepared. Even prior to the changes being adopted in this 
final rule, applicants and their representatives had certain duties 
when prosecuting applications in front of the Office. Applicant is 
required to submit fully responsive replies to Office actions (see 
Sec.  1.111) and to particularly point out and distinctly claim what 
the applicant regards as his or her invention (see 35 U.S.C. 112, ] 2). 
Furthermore, if applicant's lack of knowledge of the prior art (or lack 
of diligence) causes unnecessary delay or needless increase in the cost 
of prosecution before the Office, applicant would be violating Sec.  
10.18(b)(2)(i).
    If applicants need more time to determine the aspect of the 
invention for which patent protection should be sought, applicant may 
file a request for deferred examination under Sec.  1.103(d) upon 
filing the initial application. Applicant should have sufficient time 
to determine whether to file a divisional application for a non-elected 
invention because a divisional application is not required under this 
final rule to be filed during the pendency of the initial application, 
as long as the copendency requirement of 35 U.S.C. 120 is met. If 
applicant disagrees with the examiner's rejections, it would be more 
effective to appeal the rejections than to file a continuing 
application or a request for continued examination. It should not be 
burdensome for applicants and their representatives to prosecute 
diligently by drafting claims that particularly point out and 
distinctly claim the subject matter which the applicant regards as his 
or her invention, as well as replies that are fully responsive to the 
Office actions.
    The requirements for seeking third and subsequent continuing 
applications in this final rule will not have an effect on the vast 
majority of patent applicants. Approximately 342,600 nonprovisional 
patent applications (excluding plant and design applications) were 
filed in the Office in fiscal year 2006. Of those applications, 
approximately 32,700 were identified as continuation applications, 
approximately 15,700 were identified as continuation-in-part 
applications, and approximately 20,600 were identified as divisional 
applications. In addition, approximately 74,700 requests for

[[Page 46755]]

continued examination were filed in the Office in fiscal year 2006. The 
requirements for seeking a third or subsequent continuation or 
continuation-in-part application or a second or subsequent request for 
continued examination would only have affected 2.7 percent of these 
filings (applications or requests for continued examination). As 
discussed previously, the changes being adopted in this final rule do 
not give any advantage to those applicants who file multiple parallel 
applications containing patentably indistinct claims. See Sec. Sec.  
1.75(b)(4) and 1.78(f).
    Comment 35: One comment argued that the rule changes would 
encourage the courts to have a more liberal view on the doctrine of 
equivalents. Another comment argued that the rule changes limiting 
continuation practice takes away the right of the patentee to use 
continuing applications to secure patent protection for equivalents of 
the invention claimed in the prior-filed application, citing Festo 
Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 344 F.3d 1359, 68 
U.S.P.Q.2d 1321 (Fed. Cir. 2003) (Festo X).
    Response: The doctrine of equivalents is a patent law concept 
relating to infringement which protects patentees against efforts of 
copyists to evade liability for infringement by making only 
insubstantial changes to a patented invention. See Festo Corp. v. 
Shoketsu Kinzodu Kogyo Kabushiki Co., 535 U.S. 722, 726-27, 62 
U.S.P.Q.2d 1705, 1709 (2002) (Festo VIII). The case law on the doctrine 
of equivalents has been well established since Warner-Jenkinson Co. v. 
Hilton Davis Chem. Co., 520 U.S. 17, 41 U.S.P.Q.2d 1865 (1997) and 
Festo VIII. A concurrence in Festo X noted that the demise of the 
flexible doctrine of equivalents ``rule'' may encourage applicants to 
(inter alia) use continuation strategies to avoid the lack of 
flexibility that now exists in the doctrine of equivalents. See Festo 
X, 344 F.3d at 1375, 68 U.S.P.Q.2d 1332. This concurrence in Festo X, 
however, was not espousing some ``right'' of the patentee to use 
continuing applications to maintain the doctrine of equivalents, but 
was simply noting that applicants now use continuing application 
practice as a substitute for a flexible doctrine of equivalents.
    The Office is concerned that practitioners and applicants may 
indeed be increasingly using continuing applications not to advance 
prosecution but to compensate for changes in the law of the doctrine of 
equivalents. Such practices would appear to be likely to contravene 
Sec.  10.18(b)(2)(i), under which a party presenting a paper to the 
Office is certifying that the paper is not being presented to cause 
unnecessary delay or needless increase in the cost of prosecution 
before the Office. Under Festo X, a narrowing amendment gives rise to a 
presumption that equivalents not covered by the literal language of the 
claims have been foregone. Permitting two continuing applications plus 
a request for continued examination in any one of the initial 
application or two continuing applications as of right should in 
general assure that applicants have an adequate chance to advocate to 
the examiners that an amendment is unneeded. Beyond that, the Office is 
concerned that applications may be continued, rather than disputes on 
the need for amendment being appealed, for the purpose of delay. A 
requirement that an applicant at that stage be prepared to justify his 
or her need for an additional continuing application is reasonable in 
these circumstances.
    Comment 36: A number of comments suggested that the rule changes 
are arbitrary and capricious, premature, imprudent and ill-advised. A 
number of comments argued that the Office has no rational basis for the 
rule change, and has not provided sufficient explanations, data or 
evidence to justify the rule changes and to show that the rule changes 
will actually improve the backlog of applications, the quality of 
examinations, overall examination efficiency, quality of patents, and 
pendency. In addition, the comments asserted patents would be harder to 
enforce and litigate because all relevant prior art may not have been 
considered.
    One comment stated that the Office does not have a pendency problem 
because the average pendency is within zero to three years. One comment 
argued that the Office provides no studies to show that businesses are 
being harmed due to delayed prosecution. One comment argued that 
reducing the backlog is not an appropriate reason for limiting the 
number of continuing applications and requests for continued 
examination as a matter of right. Several comments argued that the 
Office has not identified continuation applications as a major source 
of the backlog, and therefore, the rule changes would have limited 
impact on the backlog. One comment pointed out that second and 
subsequent continued examination filings make up only a small 
percentage of the total number of continued examination filings. 
Several comments alleged that the Office's statistics are misleading 
and the rule changes would only eliminate at most five to ten percent 
of the continuation applications because the Office should not have 
included ``involuntary'' divisional applications and requests for 
continued examination. One comment argued that the Office provided no 
statistical data showing the percentage of applicants that ``misuse'' 
the continued examination practice as alleged. One comment also 
suggested that although the Continuing Applications Proposed Rule cites 
to data regarding the total number of continuations and the 
consequential burdens imposed on examiners, no analysis is provided as 
to the grounds for filing these applications and whether those grounds 
constituted ``abuse.''
    Several comments argued that there is no indication that the Office 
has conducted any serious analysis of how or why requests for continued 
examination and continuation applications are used by applicants. The 
comments suggested the following: A suitable analysis would involve 
review of prosecution histories of patents that were issued from a 
continuation application or a request for continued examination and 
determination of whether such patents could have issued if the rule 
changes were in place; and if such patents would not have issued, the 
Office should explain how such a loss of rights is consistent with the 
goals of the patent system. A number of comments asserted that the rule 
changes should be narrowly tailored to only those few applicants who 
intentionally delay the conclusion of examination rather than adversely 
impacting all applicants. A number of comments suggested that the 
Office should conduct a pilot program on the changes and report the 
results to the public prior to implementing the rule changes.
    Several comments further argued that the Office has not identified 
any study showing that restricting applicants to a single continued 
examination opportunity would satisfactorily address its problems 
without causing substantial harm to the protection of innovation or the 
patent examining process. Several comments alleged that the Office has 
not sufficiently considered the effect of the rule changes on U.S. 
applicants and the U.S. economy and suggested that further study is 
needed because the ability to file multiple continuing applications 
helps U.S. applicants to protect their inventions against foreign 
competitors and the rule changes would cause further outsourcing of 
American manufacturing and loss of American jobs.
    Several comments, however, supported the rule changes. The comments 
provided the following reasons why the rule changes would be 
appropriate: (1) They would improve

[[Page 46756]]

the Office's productivity, enhance patent quality, and eliminate 
growing abuses in the patent prosecution process, which would 
accelerate innovation, especially in the software and hardware 
technologies that have fast technology evolution and short product life 
cycle; (2) the rule changes would help the Office reduce backlog and 
pendency because they would reduce the ancillary loads on the 
examination process so that examiners can focus on important core 
issues, and the Office could focus its limited examining resources on 
faster examination of new applications; (3) the rule changes 
appropriately address those few applicants who disproportionately 
contribute to the backlog and provide applicants with the ability to 
file appropriate continued examination filings and multiple 
opportunities to present claims and arguments; (4) applicant may 
correct appropriate mistakes (including by broadening claims) through 
the reissue process; (5) by eliminating long chains of continued 
examination filings, the rule changes would provide earlier and greater 
legal certainty as to the scope of patent rights, reduce wasteful 
litigation, and encourage negotiations between patent holders and 
others; (6) the rule changes would likely promote confidence in U.S. 
patents, stimulate innovation, enhance competition, and increase 
consumer welfare; and (7) the rule changes would help to deter 
applicants from strategically using the continued examination practice 
to disadvantage competitors and their licensees, and would prevent 
applicants from keeping continuation applications pending for extended 
periods of time so that they can monitor the development of the market 
and modify their claims to cover their competitors' products.
    Response: In fiscal year 2006, the average pendency to first Office 
action was 22.6 months for the entire Patent Examining Corps. The 
average was much higher in certain areas (e.g., in Technology Center 
2100 (computer architecture, software and information security) the 
average pendency to first Office action was 30.8 months, and in 
Technology Centers 3620 and 3690 (electronic commerce) the average 
pendency to first Office action was 43.9 months). As several comments 
noted, long pendency of patent applications is problematic in some 
industries (e.g., computer software and hardware technologies) where 
product life cycles are short and new improvements can quickly make the 
technology obsolete. The Office has the authority and responsibility to 
establish regulations that shall govern the conduct of proceedings in 
the Office and facilitate and expedite the processing of patent 
applications. See 35 U.S.C. 2(b)(2). The Office has the responsibility 
to take appropriate action to improve efficiency, patent quality and 
pendency. The Office does not expect that the changes being adopted in 
this final rule alone will be sufficient to address the growing backlog 
of unexamined patent applications. The Office is implementing many 
initiatives to improve efficiency in the examination process and 
quality of patents.
    Continued examination filings divert the Office's limited examining 
resources from the examination of new applications. One of the Office's 
goals is to focus the limited examining resources on the examination of 
new applications. The rules do not place an absolute limit on the 
number of continued examination filings. The Office recognizes there 
are appropriate reasons for applicant to file a continuing application 
or request for continued examination. Under this final rule, applicant 
is permitted to file the initial application, two continuing 
applications, and a request for continued examination in an application 
family, without any justification. Thus, applicant has sufficient 
opportunities to present claims, amendments, arguments, evidence, and 
prior art during the prosecution of the initial application, two 
continuing applications, and a request for continued examination. An 
applicant who considers this to be insufficient may file a third or 
subsequent continuing application or second or subsequent request for 
continued examination with a petition and showing as to why the 
amendment, argument, or evidence sought to be entered could not have 
been previously submitted. If the amendment, argument, or evidence can 
be submitted earlier in the prosecution process, applicant is required 
to do so, rather than delay the prosecution and waste the Office's 
patent examining resources on a prosecution that is not focused. The 
examination process is more efficient when the applicant diligently 
prosecutes the application so that the examiner has all of the relevant 
information, including amendments, evidence, arguments, and prior art 
as early as possible. Most applicants who prosecute diligently will not 
need to file a third or subsequent continuing application. Reviewing 
the prosecution histories of patents, conducting pilot programs, 
publishing green papers, etc., would not show all of the reasons why 
applicants would file multiple continued examination filings. 
Applicants could have different reasons for filing continuation 
applications, continuation-in-part applications and requests for 
continued examination. The rules appropriately provide applicant the 
opportunity to show why a third or subsequent continuing application or 
second or subsequent request for continued examination is needed. The 
comments do not provide any persuasive data or evidence that shows how 
the rule changes, or any restrictions on the continued examination 
filing practice, would have a negative impact on the quality of 
patents, the U.S. economy, or innovation.
    As discussed previously, approximately 342,600 nonprovisional 
patent applications (excluding plant and design applications) and 
approximately 74,700 requests for continued examination were filed in 
the Office in fiscal year 2006. The requirements for seeking a third or 
subsequent continuation or continuation-in-part application or a second 
or subsequent request for continued examination would only have 
affected 2.7 percent of these filings (applications or requests for 
continued examination). The Office did not include divisional 
applications in this analysis. The Office included requests for 
continued examination because when an applicant files a request for 
continued examination, the examiner reopens the prosecution of the 
application and conducts another substantive examination similar to a 
continuation application.
    Comment 37: Several comments argued that the amount of resources 
spent on additional continuing applications or requests for continued 
examination is not as high as asserted because continuation 
applications and requests for continued examination take less of the 
examiner's time than new applications since the examiner is already 
familiar with the prior art, issues, and subject matter of the 
application.
    Response: The Office expects that limiting the number of continuing 
applications and requests for continued examination that may be filed 
without justification will encourage both applicants and examiners to 
focus on ``getting it right the first time.'' In any event, examiners 
are given the same amount of time to examine a continuing application 
or request for continued examination as a new application. Certain 
continuing applications and requests for continued examination could 
have more complex issues than a new application, such as evaluating new 
evidence in a biotechnology application.

[[Page 46757]]

Any reduction in the number of continuing applications and requests for 
continued examination would increase the Office's ability to focus its 
patent examining resources on the examination of new applications.
    Comment 38: Several comments asserted that the premise that 
expedited examination is more important than protection of inventor's 
rights is faulty.
    Response: The Office did not state such a premise. Applicants may 
seek full protection of their inventions under this final rule, which 
does not place any absolute limits on the number of continuing 
applications and requests for continued examination. Limiting the 
number of continuing applications and requests for continued 
examination that may be submitted without justification is not counter 
to the protection of an inventor's rights.
    Comment 39: Several comments predicted that the rule changes would 
decrease the Office's revenue due to the decrease in continuing 
applications and requests for continued examination.
    Response: The Office's goal is to utilize its patent examining 
resources more efficiently to reduce backlog and improve pendency. In 
exchange for greater efficiency, the Office expects there would be some 
decrease in revenue as the number of continued examination filings 
declines, as the comment indicates. But, this final rule is not being 
implemented with a view toward revenue; instead, it is being 
implemented to improve the patent examination process.
    Comment 40: A number of comments argued that there is no public 
notice problem. The comments argued that most applications (ninety 
percent) are published, the prosecution of the published applications 
is open to the public, and competitors are already able to analyze a 
file history to determine the broadest range of claim protection that 
may be granted in a patent of a continuing application. Several 
comments suggested that members of the public could prevent 
infringement by identifying the novel inventions in the disclosure and 
avoiding those inventions in their practices. Several comments, 
however, noted that publication of applications is not sufficient to 
provide public notice of what the patentee will ultimately claim 
because a patent may eventually issue with broader or significantly 
different claims than those published and any delays at the Office will 
perpetuate uncertainty as to the scope of the eventual patent.
    Response: The Office agrees that the publication of an application 
is not sufficient notice of the scope of protection afforded by an 
eventual patent because the claims have not been determined to be 
patentable at the time of publication. Asking the public to determine 
the broadest range of claim protection and to prevent infringement 
based on the publication of an application would defeat the purposes of 
patent examination and 35 U.S.C. 112, ] 2. The patent claims provide 
the public with notice of the patent protection, not the disclosure of 
an application.
    Comment 41: A number of comments stated that the current patent law 
already contains its own solution to the problem of long chains of 
continuing applications. The comments argued that filing and 
maintenance fees and the twenty-year patent term provision discourage 
applicants from filing continuing applications. Several comments argued 
that the Office is acting prematurely because the recent changes (e.g., 
the Office electronic filing system, the increase in hiring and fees, 
court decisions on doctrine of equivalents, the twenty-year patent term 
provisions, and publication of applications) should be sufficient to 
reduce the backlog and improve public notice. A number of comments 
alleged that the doctrine of prosecution laches is sufficient to 
address abuses. One comment argued that the Office should not be 
concerned with enforcement issues and the problem with public notice 
should not be a reason for the rule changes. Several comments argued 
that the Office's concern over public notice is misplaced because the 
notice function of claims is limited to published or patented claims 
and it does not extend to any future claims that might arise. Several 
comments, however, noted that even with the twenty-year patent term 
provisions, unrestricted continued examination practice still gives 
applicants incentives to keep continuing applications pending after the 
issuance of a patent so that the applicants can monitor the industry 
development and capture other companies' products by changing the scope 
of the claims in the continuing applications.
    Response: The percentage of continued examination filings did not 
decrease after the implementation of the twenty-year patent term 
provision of the Uruguay Round Agreement Act (Pub. L. 103-465, 108 
Stat. 4809 (1994)). Thus, the twenty-year patent term provisions do not 
discourage applicants from filing continued examination filings. As 
discussed previously, this final rule is not intended to address 
extreme cases of prosecution laches or to codify Bogese II. Examiners 
already have the authority (with a Technology Center Director's 
approval) to make a rejection on the grounds of prosecution history 
laches. See MPEP section 2190. Some of the reasons cited by the 
comments as to why an indefinite number of continuing applications is 
needed suggest that continuing applications may be used for purposes of 
delay more commonly than could be effectively addressed by the Office's 
application of its equitable prosecution history laches authority. 
Moreover, even where strategies of delay are not deliberately pursued, 
the lack of reasonable requirements on the use of continued examination 
practice may act as a disincentive to the examiner and applicant taking 
the most effective steps to reach conclusion.
    The Office did not place a per se limit on the number of continuing 
applications and requests for continued examination. The rules require 
applicant to show why a third or subsequent continuing application or 
second or subsequent request for continued examination is necessary to 
advance prosecution. The Office recognizes both the adverse effects of 
unrestricted continued examination practice, and the appropriate uses 
of continued examination filings. The Office has sought to draw a 
reasonable balance in order not to discourage appropriate uses of 
continued examination filings while providing a regulatory setting in 
which unnecessary prolongation of proceedings can be avoided. The 
changes being adopted in this final rule are appropriately tailored to 
permit applicants to file the initial application, two continuation or 
continuation-in-part applications, and a request for continued 
examination in any one of these three applications without any 
justification. An applicant who considers this to be insufficient may 
file any additional continuation or continuation-in-part application or 
request for continued examination with a petition and showing as to why 
the amendment, argument, or evidence sought to be entered could not 
have been submitted earlier. The changes in this final rule will also 
permit the Office to focus its limited resources on examination of new 
applications in order to reduce the backlog of unexamined applications.
    Comment 42: One comment argued that the Office's assertion that 
multiple patents tend to defeat the public notice function of patent 
claims does not justify the rule changes because the restriction 
practice tends to increase the number of patents. One comment argued 
that the Office is making unsupported assumptions that: (1) The 
possible issuance of multiple patents

[[Page 46758]]

arising from continuing applications tends to defeat the public notice 
function of patent claims; and (2) the public is left uncertain as to 
what a set of patents resulting from the initial application will cover 
when multiple applications with patentably indistinct claims are filed.
    Response: Restriction practice encourages applicant to file a 
single application for each patentably distinct invention. The public 
notice function of patent claims is undermined, however, when multiple 
patents together claim only one patentable invention (i.e., the patents 
contain patentably indistinct claims). In such case, applicant should 
file a single application claiming one patentable invention rather than 
multiple applications claiming the same patentable invention. The 
Office is not making unsupported assumptions that the possible issuance 
of multiple patents arising from continuing applications tends to 
defeat the public notice function of patent claims, and that the public 
is left uncertain as to what a set of patents resulting from the 
initial application will cover when multiple applications with 
patentably indistinct claims are filed. See, e.g., To Promote 
Innovation: The Proper Balance of Competition and Intellectual Property 
Law and Policy, Ch. 4 at 26-31 (Federal Trade Commission 2003); Lemley 
and Moore, Ending Abuse of Patent Continuations, 84 B.U. L. Rev. at 100 
(eliminating continuing application practice would be consistent with 
the policy goal of giving adequate notice about what is and is not 
covered by a patent).
    Comment 43: Several comments predicted that the rule changes would 
discourage public disclosure of technology, thereby hurting industrial 
growth and innovation. Several comments argued that by limiting an 
applicant's ability to claim everything that is disclosed in the 
application, the rule changes would cause the applicant to submit more 
narrow disclosures to avoid inadvertent dedication of the subject 
matter to the public (citing Johnson & Johnston Associates, Inc. v. 
R.E. Service Co., 304 F.2d 1235, 62 U.S.P.Q.2d 1225 (Fed. Cir. 2002) 
(en banc)). Several comments noted that the rule changes would force 
applicants to delay filing until all foreseeable information has been 
obtained or forego continuation-in-part filings that contain additional 
information. Several comments stated that small entities that have 
limited resources would not disclose alternative embodiments or would 
file applications with narrow disclosures to avoid restriction 
requirements. Several comments averred that inventors would delay the 
filing of applications until after clinical or market testing is 
concluded, a potentially commercially viable product is identified, or 
other refining of the invention is completed. The comments also 
predicted that some inventors would keep the invention secret from the 
public and/or limit the scope of the disclosure to avoid dedicating 
potentially commercial embodiments to the public. One comment argued 
that the Office is making an unsupported assumption that continuing 
applications and multiple applications containing patentably indistinct 
claims impose a burden on innovation. One comment argued that 
applicants would file multiple applications having divergent subject 
matter rather than a single application and applicants would omit 
certain concepts from the applications. One comment stated that the 
prior art complications caused by the inability to claim priority of an 
earlier filed application through intermediate applications would 
severely curb disclosure because applicants would avoid creating their 
own prior art under 35 U.S.C. 102(b) on a possible important commercial 
embodiment. One comment stated that the current continued examination 
practice encourages early disclosure of multiple embodiments of 
inventions developed through the iterative design process. One comment 
stated that large applications that disclose everything are good and 
advance the Office's mission. One comment argued that the proposed rule 
changes to the examination of claims will force applicants to file 
applications that incorporate secondary features into their own 
separately filed application. One comment argued that the new rules 
would result in omnibus filings on anything and everything.
    Response: The Office has made modifications to the proposed rules 
concerning both continuing applications and examination of claims 
practices. First, this final rule permits an applicant to file two 
continuation applications or continuation-in-part applications, plus a 
single request for continued examination in an application family, 
without any justification. Second, this final rule permits applicants 
to present more than five independent claims or more than twenty-five 
total claims in an application if applicant files an examination 
support document before the first Office action on the merits of the 
application. Taken together, the changes to continuing application and 
examination of claims practices adopted in this final rule permit 
applicant to file as many claims as desired in one application and give 
applicant sufficient opportunity to seek appropriate protection for the 
disclosed invention. Accordingly, the changes being adopted in this 
final rule do not place a per se limit on the number of claims 
presented in an application, nor do they place a per se limit on the 
number of continuing applications and requests for continued 
examination available in an application family. The changes being 
adopted in this final rule likewise do not give any advantage to those 
applicants who file multiple applications that contain patentably 
indistinct claims because such applicants would be required to identify 
the multiple applications that contain patentably indistinct claims. 
See Sec. Sec.  1.75(b) and 1.78(f).
    The changes adopted in this final rule will not discourage 
applicants from filing patent applications because the substantive 
criteria for entitlement to a patent and the basic incentives for a 
patent (exclusive rights) have not changed. Whether applicants file 
narrow or broad disclosures, the changes in this final rule will reduce 
uncertainty with respect to what the applicant is claiming as the 
invention. The Office also does not expect applicants to delay the 
filing of an application because any commercial activities and public 
disclosures that occurred more than one year prior to the filing of an 
application would still be considered prior art under 35 U.S.C. 102(b). 
The changes being adopted in this final rule simply require applicants 
to prosecute their applications diligently and submit amendments, 
argument, and evidence early in the prosecution of the initial 
application, two continuing applications and a request for continued 
examination. As previously discussed, applicant has sufficient time to 
determine whether to file a divisional application. If applicant needs 
more time to determine which aspect of the invention to seek protection 
for, applicant may file a request for deferral of examination under 
Sec.  1.103(d).
    Comment 44: Several comments alleged that the rule changes would 
have a significant adverse impact on applicants if the first-to-file 
system is adopted because applicants would need to file more continuing 
applications to protect their inventions because applicants would need 
to file as soon as possible with broadly conceptualized disclosures and 
subsequently file continuing applications (e.g., continuation-in-part 
applications) on the improvement or detailed embodiments.
    Response: The United States currently does not have a ``first 
inventor-to-file''

[[Page 46759]]

standard. Other countries that have a ``first inventor-to-file'' 
standard have less flexible continued examination practice than the 
United States. For example, the Japan Patent Office does not permit 
continuation-in-part applications. Under the JPO practice, applicant 
may only submit an application on an improvement as a new application. 
The Office will continue to consider the issues related to the ``first-
to-invent'' standard and the ``first inventor-to-file'' standard in 
determining the rights to a patent in the context of international 
harmonization efforts.
    Comment 45: A number of comments argued that the rule changes would 
disproportionately impact small entities including universities, start-
up companies, biotechnology companies, and public health industry 
because they are more likely to file continuing applications and 
requests for continued examination and have less resources. The 
comments provided the following reasons: (1) The proposed rule would 
require significant expenses early in the prosecution of the 
application that would cause small entities and independent inventors 
economic hardship; (2) the rule changes would encourage large companies 
that have more financial resources to ``steal'' inventions from the 
small entities because the increased cost of obtaining patent 
protection would prevent small entities from obtaining full protection 
of their inventions and cause many small entities not to seek patent 
protection; (3) small entities need the flexibility to respond to 
changing conditions by refining claims and they cannot afford up-front 
parallel filings as large companies can; (4) independent inventors and 
small entities need the ability to file multiple continued examination 
filings to spread the costs; (5) the rule changes could stifle the 
building of patent portfolios for small companies and cause a reduction 
of capital investment in these companies and in new technologies; (6) 
applicants should be permitted to get a patent on the allowed claims 
and then continue to prosecute the broader or rejected claims or to 
claim subject matter not previously claimed in a continuing 
application, in order to bring technologies to the market sooner, which 
would permit small entities to attract investors and obtain financing 
for further product development and patent prosecutions; (7) continued 
examination filings are more likely needed in complex fields like 
biotechnology because examiners are less likely to comprehend the 
invention fully in the limited time allotted for the initial search and 
examination and more likely to make restriction requirements, and 
applicants need additional opportunities to address technical issues 
arising during prosecution and submit evidence and clinical testing 
data; (8) companies in the life sciences need continued examination 
filings to obtain multiple patents that protect innovations and 
improvements that arise over the long time period of research and 
development, clinical testing, and the Food and Drug Administration 
(FDA) approval process; (9) in biotechnology, applicants may not know 
at the time of filing which embodiments of the invention have 
commercial value or how a competitor may attempt to copy the invention 
or circumvent the patent. One comment that supports the rule changes 
noted that large entities also operate within limited filing budgets, 
and the effects of the rules will apply across the board because any 
applicant must decide what level of filing activity it can reasonably 
afford, and make filing decisions accordingly. The comment further 
stated that small entities already receive a fifty percent discount on 
fees and can take advantage of inexpensive provisional applications to 
delay paying filing fees. Several comments argued that the rule changes 
will disproportionately impact small entities and that the Office 
obscures this fact by including requests for continued examination into 
the analysis. The comments stated that: 32 percent of patents to the 
top nineteen universities are continuation or continuation-in-part 
applications; 35.2 percent of first continuations and continuation-in-
part applications are filed by small entities; and 37.9 percent of 
second continuations and continuation-in-part applications are filed by 
small entities.
    Response: The Office notes the concerns expressed in the public 
comment particularly by small entities regarding the proposed changes 
to Sec. Sec.  1.78(d)(1) and 1.114 that would have permitted an 
applicant to file only one of the following: A continuation 
application, a continuation-in-part application, or a request for 
continued examination, without any justification. The Office has made 
modifications to these proposed changes such that this final rule will 
permit an applicant to file two continuation applications or 
continuation-in-part applications, plus a single request for continued 
examination in an application family, without any justification. Under 
this final rule, an applicant may file a divisional application 
directed to a non-elected invention if the prior-filed application is 
subject to a requirement for restriction. The divisional application 
need not be filed during the pendency of the application subject to a 
requirement for restriction, as long as the copendency requirement of 
35 U.S.C. 120 is met. This final rule also permits applicant to file 
two continuation applications of a divisional application plus a 
request for continuation examination in the divisional application 
family, without any justification. Applicant may also file any third or 
subsequent continuation or continuation-in-part application, or any 
second or subsequent request for continued examination in an 
application family, with a petition and showing. Therefore, applicants 
should have sufficient time to determine whether to seek protection for 
a particular aspect of an invention and should have sufficient 
opportunities to present claims, amendments and evidence for that 
aspect. For example, applicant is permitted to obtain a patent on the 
allowed claims from the initial application, and then continue to 
prosecute the broader or rejected claims in two continuation or 
continuation-in-part applications, and one request for continued 
examination without justification. Beyond those filings, applicant may 
seek a third or subsequent continuation or continuation-in-part 
application and a second or subsequent request for continued 
examination with a petition and showing. As previously discussed, the 
changes being adopted in this final rule do not give any advantage to 
those applicants who file multiple parallel applications containing 
patentably indistinct claims. See Sec. Sec.  1.75(b)(4) and 1.78(f).
    Applicant should also have sufficient opportunities to spread the 
cost of prosecution. Applicant has a one-year grace period under 35 
U.S.C. 102(b) before filing a patent application to test the market or 
obtain capital resources. Before the end of the one-year grace period, 
applicant may file a provisional application to obtain a U.S. filing 
date and wait up to twelve additional months to file an initial 
nonprovisional application. During this two-year time period, 
applicants may determine the commercial value of each aspect of the 
invention before filing the initial nonprovisional application. 
Applicant may also request a deferral of examination under Sec.  
1.103(d) and defer the examination up to three years from the earliest 
filing date claimed (e.g., the filing date of the provisional 
application). See Sec.  1.103(d). By

[[Page 46760]]

requesting a deferral of examination, applicant would have even more 
time to determine the commercial value of the invention or obtain 
capital resources and would avoid the cost of filing and prosecuting 
multiple continued examination filings. Furthermore, divisional 
applications need not be filed during the pendency of the application 
subject to a requirement for restriction, as long as the copendency 
requirement of 35 U.S.C. 120 is met.
    The changes being adopted in this final rule do not 
disproportionately impact small entities. The Office estimates that the 
change would have required such a petition and showing in only 2.9 
percent of the 112,210 small entity applications and requests for 
continued examination filed in fiscal year 2006. The Office included 
the number of requests for continued examination into the analysis 
because requests for continued examination divert the Office's patent 
examining resources from the examination of new applications and 
contribute to the increasing backlog of unexamined applications, just 
like continuation and continuation-in-part applications.
    The Office notes that, during fiscal year 2006, it appears that the 
percentage of small entity continued examination filings that would 
have required a petition is slightly higher than the percentage of 
total continued examination filings that would have required a petition 
(2.9 percent small entity as opposed to 2.7 percent for all 
applicants). The Office also notes that, during fiscal year 2006, it 
appears that the percentage of small entity applications that exceeded 
the five independent claims and twenty-five total claim threshold is 
also slightly higher than the percentage of total applications that 
exceeded the five independent claim and twenty-five total claim 
threshold (24.4 as opposed to 23.7). These percentages are based upon 
data that is available in the Office's PALM system for applications 
filed during the most recent fiscal year. The Office does not think 
these slight differences establish that the changes in this final rule 
will have a disproportionate economic impact on small entities since 
these differences are within the margin of error. In addition, the 
comments provide no reason, and there is no apparent one for why small 
entity applicants would inherently require more continued examination 
filings to prosecute the applications to completion or more claims to 
adequately cover their inventions. Thus, even higher differences in 
these percentages could easily be explained by the fact that small 
entity applicants pay only one-half of the fees that other applicants 
pay for continuing applications, requests for continued examination, 
and excess claims.
    Comment 46: A number of comments predicted the rule changes would 
limit applicants' opportunities to present claims, which would reduce 
the scope of the patent claims because applicants would be pressured to 
pursue and accept narrower claims. The comments argued that inventors 
would not be able to adequately protect their inventions and would in 
turn lose patent protection to certain aspects of their inventions, 
which would have an adverse impact on the value of patents, patent 
quality, innovations, research and development, the competitiveness of 
U.S. companies, and the U.S. economy and would eliminate U.S. jobs. The 
comments provided the following reasons: (1) The Office has not 
appropriately addressed applicants' interests in maximizing patent 
protection and receiving a fair consideration of all claims submitted; 
(2) the rule changes would require applicants to claim all aspects of 
the disclosed invention initially, even though applicants often file 
applications without knowing the value of their inventions in order to 
determine which embodiment will have value and be worthy of the 
investment in patent protection; (3) applicants would not be able to 
identify and address all claim permutations in the initial application 
and one continuation application, and complex inventions often need 
more claims and more than one continuation application to protect the 
invention; (4) the Office should provide applicants the flexibility to 
prosecute different embodiments at a later time; (5) the applicant 
should be permitted to present claims (or change the scope of the 
claims) in continuing applications to cover an embodiment of the 
invention disclosed in the initial application when the applicant later 
determines the commercial value of the embodiment, develops the actual 
product, or discovers a potential infringer's product; (6) competitors 
could easily circumvent the patent claims because applicant would not 
have the ability to change the scope of the claims to cover the 
competitor's product in a continuing application; (7) in view of the 
courts' restrictive claim interpretation, the required showing under 
Sec. Sec.  1.78(d)(1) and 1.114 would eliminate a vast number of 
legitimate continuing applications and requests for continued 
examination needed to provide coverage of alternate aspects of an 
invention.
    Response: This final rule does not place any per se limits on the 
number of continued examination filings that may be filed or on the 
number of claims an applicant may present in an application. Applicant 
is permitted to submit all of the claims that applicant desires during 
the prosecution of the initial application, two continuation or 
continuation-in-part applications, and a request for continued 
examination. An applicant who considers this to be insufficient may 
file a third or subsequent continuing application or second or 
subsequent request for continued examination with a petition showing 
why the amendment, argument, or evidence sought to be entered could not 
have been submitted earlier. For most applicants who prosecute their 
applications diligently, additional continued examination filings would 
not be needed. Applicant may also file a reissue application under 35 
U.S.C. 251, if appropriate, to submit claims with different scope. 
Further, the use of continuation practice to circumvent statutory 
requirements for reissue and reexamination proceedings is not 
appropriate. In addition, the rules require an applicant to advance 
prosecution and not waste the Office's resources examining an 
application when the applicant is not ready to particularly point out 
and distinctly claim the subject matter which the applicant regards as 
his or her invention. See also Sec.  10.18(b)(2)(i) and Hyatt v. Dudas, 
2007 U.S. App. LEXIS 15350 (Fed. Cir. Jun. 28, 2007). Applicant should 
not use continued examination practice to delay the prosecution of the 
application because this adversely impacts the Office's ability to 
examine new applications and reduce the backlog of unexamined 
applications.
    Comment 47: One comment predicted that the rule changes would 
discourage first action allowances because some applicants would 
intentionally file applications with at least one defect in order to 
receive a rejection to drag out pendency so that they can have more 
time to determine whether to file continuing applications.
    Response: There is no reason why the new changes being adopted in 
this final rule will encourage an applicant to intentionally file an 
application with at least one defect to delay prosecution. 
Additionally, such an action by an applicant would violate Sec.  
10.18(b)(2)(i). By presenting to the Office any paper (including an 
application), the applicant is certifying that to the best of the 
applicant's knowledge, information and belief, formed after an inquiry 
reasonable under the circumstances, that the paper is not being 
presented to cause unnecessary delay or needless

[[Page 46761]]

increase in the cost of prosecution before the Office.
    Comment 48: One comment sought clarification as to whether an 
applicant is permitted to amend the claims and/or file a continuation 
application to claim allowable subject matter presented in dependent 
claims.
    Response: Applicant may amend the claims of an initial application 
to claim allowable subject matter presented in dependent claims if the 
amendment complies with the rules of practice (e.g., Sec.  1.116). For 
example, applicant may submit such an amendment in the initial 
application in response to a non-final Office action in the initial 
application. Such an amendment, however, will not be entered in the 
initial application as a matter of right after a final Office action. 
Under this final rule, applicant alternatively may file two 
continuation or continuation-in-part applications plus one request for 
continued examination in an application family, without any 
justification and pursue the amendment in one of those two applications 
or in the request for continued examination.
    Comment 49: Several comments argued that the combined effect of the 
limit on the number of representative claims and the limit on the 
number of continuing applications and requests for continued 
examination as a matter of right would increase the number of multiple 
parallel applications and divisional applications because applicants 
would file more multiple parallel applications with small numbers of 
claims or present claim sets that would provoke restriction 
requirements. Either way, the comments contended that the backlog will 
increase. One comment further alleged that applicants would file more 
continued examination filings and appeals because by limiting the 
number of claims examined, two Office actions would be insufficient, 
thus resulting in an increase in pendency and cost. One comment argued 
that the rule changes would disproportionately impact inventions that 
require more claims, continuing applications, or examiner time. One 
comment stated that the limitations on continued examination filings 
and claims would cause more litigation because they would create more 
uncertainty in infringement and validity.
    Response: As discussed previously, the Office is not adopting the 
``representative claims'' examination approach or restricting the 
number of continued examination filings to one without any 
justification. Rather, this final rule permits applicant to present 
more than five independent claims or more than twenty total claims in 
an application if applicant files an examination support document. 
Applicant is also permitted to file two continuation or continuation-
in-part applications, plus a request for continued examination in an 
application family, without any justification. The changes being 
adopted in this final rule do not place per se limits on the number of 
claims which applicant may present in an application or on the number 
of continued examination filings. The changes being adopted in this 
final rule do not encourage applicant to file multiple parallel 
applications that contain patentably indistinct claims. See Sec. Sec.  
1.75(b)(4) and 1.78(f). Applicants would obtain little benefit from 
filing multiple applications that contain patentably indistinct claims 
because the Office would treat each application as having the total of 
all of the claims (whether in independent or dependent form) in all 
such applications for purposes of determining whether an examination 
support document is required by Sec.  1.75(b)(1) (but not for purposes 
of calculating the excess claims fee due in each application). 
Likewise, this final rule will not cause the number of divisional 
applications to increase because this final rule permits divisional 
applications to be filed serially. Therefore, applicant should have 
sufficient time to determine whether to file a divisional application 
to claim a non-elected invention.
    Comment 50: A few comments suggested that the limits set in 
Sec. Sec.  1.75(b)(4) and 1.78(d)(1) are inconsistent with interference 
practice under 35 U.S.C. 135 of copying claims for purposes of 
preserving the right to provoke an interference. One comment suggested 
that the changes to Sec.  1.78 eliminates an applicant's right to add 
claims to an application to cover a similar or parallel technology, 
provided that the added claims find support in the specification, 
citing PIN/NIP, Inc., v. Platt Chemical Co., 304 F.3d 1235, 1247, 64 
U.S.P.Q.2d 1344, 1352 (Fed. Cir. 2002). One comment stated that 
subjecting patentably indistinct claims in multiple commonly owned 
applications to elimination under Sec.  1.78(f)(3) violates case law, 
for example Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 
F.2d 867, 874, 9 U.S.P.Q.2d 1384, 1390 (Fed. Cir. 1988).
    Response: The Office has modified proposed Sec.  1.75(b)(4) and 
Sec.  1.78(d)(1). This final rule permits an applicant to file two 
continuation or continuation-in-part applications plus one request for 
continued examination in an application family, without any 
justification. Applicant may also file a third or subsequent 
continuation or continuation-in-part application or a second or 
subsequent request for continued examination with a petition and 
showing. This final rule permits applicant to present up to five 
independent claims or twenty-five total claims in each application, 
without an explanation. Applicant may also present more than five 
independent claims and more than twenty-five total claims if applicant 
files an examination support document before the first Office action on 
the merits of the application. Applicant may file as many claims as 
necessary to claim the full scope of his or her invention. This final 
rule provides sufficient opportunities for applicant to present claims 
to provoke an interference during the prosecution of these 
applications. Therefore, the changes to Sec. Sec.  1.75(b)(4) and 
1.78(d)(1) being adopted in this final rule are not inconsistent with 
35 U.S.C. 135. Furthermore, applicant may also file a reissue 
application under 35 U.S.C. 251, if appropriate, to submit claims for 
provoking an interference. In other situations, however, applicant is 
not permitted to maintain an application in pending status, without 
advancing prosecution, for the sole purpose of awaiting developments in 
similar or parallel technology. As previously discussed, such practice 
does not advance prosecution before the Office and impairs the ability 
of the Office to examine new and existing applications.
    In other situations, however, applicant is not permitted to 
maintain an application in pending status, without advancing 
prosecution, for the sole purpose of awaiting developments in similar 
or parallel technology. As previously discussed, such practice does not 
advance prosecution before the Office and impairs the ability of the 
Office to examine new and existing applications.
    The Federal Circuit noted in PIN/NIP that one may amend an 
application for the purpose of encompassing devices or processes of 
others, subject to compliance with the requirements of the patent 
statute and regulations (the claim at issue was determined to be 
invalid under 35 U.S.C. 112, ] 1, for lack of written description 
support). See PIN/NIP, 304 F.3d at 1247, 64 U.S.P.Q.2d at 1352. As 
such, PIN/NIP cannot be relied upon to support a ``wait and see'' 
concept under which an applicant files an initial application followed 
by a stream of continuation applications just to wait for any 
competitor to develop and market an invention not claimed in the 
initial application. PIN/NIP, 304

[[Page 46762]]

F.3d at 1247, 64 U.S.P.Q.2d at 1352. Further, in Kingsdown, the Federal 
Circuit opined: ``Nor is it in any manner improper to amend or insert 
claims intended to cover a competitor's product the applicant's 
attorney has learned about during the prosecution of a patent 
application. Any such amendment or insertion must comply with all 
statutes and regulations, of course, but, if it does, its genesis in 
the marketplace is simply irrelevant.'' Kingsdown, 863 F.2d at 874, 9 
U.S.P.Q.2d at 130. This statement does not equate to a pronouncement 
that an applicant has a ``right'' under the patent statutes to file a 
continuous stream of continuing applications to ensure that there is 
always a pending application in which to present claims encompassing 
devices or processes of others.
    Further continuation practice is not intended to supplant or permit 
circumvention of reissue practice. The patent statute at 35 U.S.C. 
chapter 25 provides for the correction of patents, and specifically 
provides for the reissue of a patent in those situations in which a 
``patent is, through error without any deceptive intention, deemed 
wholly or partly inoperative or invalid, by reason of * * * the 
patentee claiming more or less than he had a right to claim in the 
patent.'' See 35 U.S.C. 251. See also Toro Co. v. White Consol. Indus., 
383 F.3d 1326, 1333, 72 U.S.P.Q.2d 1449, 1454 (Fed. Cir. 2004) (citing 
Johnson & Johnston, 304 F.2d at 1055, 62 U.S.P.Q.2d at 1231). Nothing, 
however, suggests that an applicant has a ``right'' under the patent 
statutes to file a continuing application to avoid the requirements of 
the reissue statute when seeking to correct or enlarge the scope of a 
patent. There is a difference between adding claims to an application 
that are otherwise pending, and deliberately prolonging prosecution in 
order to be able to do so. Deliberately prolonging a proceeding before 
the Office would not be consistent with the requirements of Sec.  
10.18.
    Applicant may copy claims from another application or patent that 
is not commonly owned for the purposes of provoking an interference, 
without triggering Sec.  1.78(f)(3). Section 1.78(f)(3) applies only to 
multiple commonly owned applications that contain patentably indistinct 
claims. Section 1.78(f)(3) is a restatement of former Sec.  1.78(b), 
which previously gave the Office the same discretion to require 
elimination of patentably indistinct claims in all but one of the 
pending nonprovisional applications. The Office is not preventing 
applicants from providing such patentably indistinct claims in a single 
application, or in multiple applications if applicant submits a 
terminal disclaimer in accordance with Sec.  1.321(c) and explains why 
submitting patentably indistinct claims in separate applications is 
necessary.
    Comment 51: Several comments suggested that if the Office 
implements the limits on continued examination filings, the limits on 
the number of claims would be unnecessary.
    Response: The comment provides no explanation as to how or why 
implementation of the continued examination filing changes would make 
the claims provisions unnecessary. The Office determined that the 
implementation of the changes to the continued examination practice and 
practice for examination of claims in patent applications are necessary 
to achieve quality and efficiency in the patent examination process.
    Comment 52: A number of comments argued that applicants should be 
permitted to file more than one continuation or continuation-in-part 
application or request for continued examination as a matter of right 
because there are many legitimate reasons for the filings. The comments 
provided the following examples: (1) The process of developing the best 
prior art and obtaining the broadest possible protection is a complex 
process and may extend the prosecution process; (2) applicants may use 
strategies that would avoid prosecution history estoppel and preserve 
doctrine of equivalents protection; (3) applicants may maintain a 
continuing application so that they could respond to any adverse court 
decisions and associated uncertainties; (4) the quality of the 
examination process may cause delays; (5) examiners would allow broader 
claims in a continuation application after becoming more familiar with 
the subject matter and have more time to improve the search and 
analysis; (6) applicants may maintain a continuing application pending 
to prevent competitors from copying the invention or circumventing the 
initial patent claims because the courts are less inclined to interpret 
the scope of invention beyond the literal meaning of the claims, 
precluding claim scope that once was captured under the doctrine of 
equivalents; (7) applicants may file continuation applications as an 
``insurance policy'' so that applicants can correct any defects found 
in the first patent or adjust the claim coverage without surrendering 
the patent (as in the reissue and reexamination practices); (8) 
applicants may file continuing applications to build large patent 
portfolios and attract capital investments; (9) applicants want time to 
conduct testing and to reevaluate the claim scope in light of new prior 
art, market experience, and technology development; (10) for complex 
technologies, it may take several prosecutions to determine the bounds 
of patentable subject matter; (11) applicants may want many patents on 
an invention to strengthen the protection; (12) applicants may file 
continuing applications to correct errors in the initial prosecution 
including those made by inexperienced representatives or applicants; 
and (13) applicants who are in a crowded or highly valuable field need 
to keep a continuing application pending for the purposes of provoking 
interference.
    Response: The Office recognizes that there are some appropriate 
reasons for filing multiple continuing applications and requests for 
continued examination. There are, however, a number of reasons given 
for multiple continuing applications and requests for continued 
examination that are not considered appropriate. The changes being 
adopted in this final rule are tailored to permit applicants to file 
the initial application, two continuation or continuation-in-part 
applications, and a request for continued examination in an application 
family, without any justification. Any applicant who considers this to 
be insufficient may file an additional continuation or continuation-in-
part application or a request for continued examination with a petition 
showing why the amendment, argument, or evidence sought to be entered 
could not have been submitted during the prosecution of the prior 
filings. Applicants are required to prosecute diligently and to 
particularly point out and distinctly claim the subject matter which 
the applicant regards as his or her invention, upon filing the 
application. If applicant's lack of knowledge of prior art, or lack of 
diligence during the prosecution of the application, causes unnecessary 
delay or needless increase in the cost of prosecution before the 
Office, applicant would be violating his or her duty under Sec.  10.18. 
See Sec.  10.18(b)(2)(i).
    Comment 53: A number of comments argued that many continuing 
applications and requests for continued examination are caused by 
inadequate examinations, the final Office action practice, and the 
examiner production system. The comments provided the following 
examples: (1) It may take several exchanges between the examiner and 
applicant before the examiner appears to understand the invention; (2) 
examiners' lack of experience in the art and patent law; (3) some 
examiners have difficulty using the English

[[Page 46763]]

language in oral and written communications; (4) the Office has large 
turnover in examining personnel; (5) examiners make too many 
restriction requirements; (6) examiners want to obtain additional 
``counts''; (7) examiners make improper rejections; (8) examiners 
refuse to enter any after-final replies; (9) examiners are not given 
sufficient time to conduct a proper search and examination in the 
initial application; (10) examiners did not read the specification and 
claims; (11) examiners do not adequately consider arguments made by the 
applicants; (12) examiners make premature final rejections; (13) 
examiners conduct piecemeal examination; (14) examiners are being 
overturned by supervisors or quality control; (15) examiners do not 
indicate allowable claims; (16) examiners do not set forth the 
rejections clearly in the Office actions; (17) examiners do not apply 
legal standards consistently; and (18) examiners make new grounds of 
rejection or cite new art in final Office actions.
    Response: The Office provides applicant with procedures to address 
inadequate examination issues. Applicant should not use the continued 
examination practice as a substitute for the petition or appeal 
process. The practice of permitting an unlimited number of continuing 
applications and requests for continued examination appears to have 
created lax practices. Applicants should raise any issue of inadequate 
examination before the examiner and/or the examiner's supervisor. For 
example, applicants should raise any question as to prematureness of a 
final rejection before the primary examiner. Applicant may seek review 
of the examiner's decision on the finality of the Office action by 
petition under Sec.  1.181, if appropriate. See MPEP Sec. Sec.  
706.07(c) and 1002.02(c). Restriction requirements are also reviewable 
by petition under Sec.  1.181. Applicants may request an interview with 
the examiner to ensure that the examiner understands the invention or 
claims correctly, or to seek clarification of the rejections or Office 
action. See Sec.  1.133(a)(2). If applicant disagrees with the 
examiner's rejections, applicant may appeal the rejections to the BPAI 
and/or request a pre-appeal brief conference, if appropriate.
    Comment 54: A number of comments argued that filing continuing 
applications and requests for continued examination is more efficient 
and cost-effective in dealing with deficiencies of the examination 
process (even before a ``stubborn examiner'') because the factual 
record is fixed on appeal and the appeal process takes a longer time 
and is expensive, especially for independent inventors and small 
entities. The comments predicted that the rule changes would increase 
the number of pre-appeal brief conferences, examiner's answers and 
appeals, and force applicants to appeal applications that are not in 
condition for appeal (e.g., the record has not been fully developed and 
unamended claims may be appealed). Several comments pointed out that 
continuing applications and requests for continued examination help 
applicants to place the application in better condition for appeal 
because most examiners refuse to enter the after-final amendments. One 
comment stated that some applicants might file the appeal simply to 
preserve pendency. Some of the comments suggested that the Office 
should wait and see what effect a quicker appeal process would have on 
the backlog before implementing the rule changes. The comments stated 
that once applicants appreciate the appeal process changes, more 
applicants would file appeals rather than continuing applications and 
requests for continued examination. Furthermore, the comments noted 
that a study conducted by a firm shows that out of 121 appeal briefs 
(appeals from January 1, 2004 to March 23, 2006), examiners issued only 
nine answers, which represents an enormous waste of applicants' time 
and money. One comment predicted that the BPAI would be quickly 
overwhelmed and a broken appeal process would create more damage to the 
examination process than the current problems.
    Response: If applicant disagrees with the examiner's rejections, 
applicants should file an appeal rather than filing a continuation 
application or a request for continued examination. The appeal process 
offers a more effective resolution than the filing of a continuation 
application or a request for continued examination. The pre-appeal 
brief conference program provides applicant a relatively expeditious 
and low cost review of rejections by a panel of examiners. If, after 
the conference, the prosecution is reopened, the applicant will have a 
further opportunity to prosecute in front of the examiner. Applicant 
would not need to file an appeal brief. If the Office decides that the 
application should remain under appeal, it would be more efficient to 
appeal the rejection to the BPAI by filing an appeal brief rather than 
delay the appeal by filing a continuation application or a request for 
continued examination. Furthermore, the pendency of an appeal is 
relatively short. The current (as of the end of the second quarter of 
fiscal year 2007) pendency of a decided appeal was 5.6 months. The 
pendency of an appeal is the period between the assignment of an appeal 
number and the mailing date of the decision. In addition, the BPAI has 
reduced the inventory of pending appeals from 9,201 at the close of 
fiscal year 1997 to 1,357 at the close of fiscal year 2006. 
Nevertheless, continuing applications and requests for continued 
examination as a percentage of total filings have increased as BPAI 
appeal pendency and inventory of pending appeals has decreased. 
Applicants should have sufficient opportunity to place the application 
in condition for appeal during the prosecution of the initial 
application, two continuing applications, and one request for continued 
examination in an application family. An applicant who considers this 
to be insufficient may file any third or subsequent continuation or 
continuation-in-part applications or second or subsequent requests for 
continued examination with a petition showing why the amendment, 
argument, or evidence sought to be entered could not have been 
previously submitted.
    Comment 55: Several comments alleged that the Office has provided 
no evidence for the assertion that the exchange between applicants and 
examiners becomes less beneficial and suffers from diminished returns 
after the initial application. A number of comments also argued that 
the Office did not provide any investigation or analysis of the 
frequency with which the value of exchanges between the examiner and 
applicant decrease after the first continuing application or request 
for continued examination. A number of comments suggested that 
continuing applications and requests for continued examination permit 
additional mutually beneficial interaction between the examiner and 
applicant because: (1) The examiner and applicant already are familiar 
with the issues in the prosecution; (2) they give the examiner more 
time to examine the same subject matter and gain better understanding 
of the prior art; and (3) they permit applicants multiple opportunities 
to refine the claims and present additional data or evidence which 
would result in better quality patents with valid claims and clearly 
defined subject matter. Several comments argued that the rule changes 
would not improve public notice and the exchanges between the examiner 
and applicant because applicants would file multiple parallel 
applications rather than one single application and the applications 
would be assigned to

[[Page 46764]]

different examiners. Several comments argued that the exchanges between 
the examiner and applicant would be less efficient and more contentious 
because applicants would present broader claims and argue rejections 
more aggressively resulting in higher pendency. Several comments also 
predicted that applicant would request more interviews which would be 
more work for both the examiner and applicant. Several comments argued 
that it is unclear how the exchange between examiners and applicants 
will be more efficient because there is nothing in the proposal to 
encourage examiners to be more reasonable and appeals are not more 
efficient. One comment also argued that the Office is making 
unexplained assumptions that: (1) The value of a continuing application 
or a request for continued examination is less than the value of a new 
application; (2) the changes to continuing applications practice being 
adopted in this final rule should improve the quality of issued 
patents, making them easier to evaluate, enforce, and litigate; (3) 
this small minority of applicants prejudices the public permitting 
applicants to keep applications in pending status while awaiting 
developments in similar or parallel technology and then later amending 
the pending application to cover the developments; and (4) the changes 
being adopted in this final rule will result in claims issuing faster.
    Response: Under this final rule, applicant is permitted to file two 
continuation or continuation-in-part applications plus one request for 
continued examination in an application family. These filings will 
provide sufficient opportunities for applicants to submit amendments, 
arguments, and evidence. Furthermore, the exchange between applicant 
and the examiner will be more efficient because applicant can no longer 
delay the submissions of amendments, argument, and evidence and the 
examiner will have the information earlier to determine the 
patentability of the claims. In addition, even if one could argue that 
additional continuing applications and requests for continued 
examination are beneficial in the particular application, the marginal 
value of a third or subsequent continuing application or a second or 
subsequent request for continued examination vis-[aacute]-vis the 
patent examination process decreases due to the Office resources 
occupied by the additional continued examination filings for 
amendments, argument, and evidence that could have been presented 
earlier. Nevertheless, an applicant can show on petition that an 
additional filing is necessary. Finally, the changes being adopted in 
this final rule require applicant to submit all of the claims that are 
patentably indistinct in one single application and to identify 
multiple applications that contain patentably indistinct claims. See 
Sec. Sec.  1.75(b) and 1.78(f).
    Comment 56: One comment argued that the Office should not impose a 
limit on the number of continuing applications an applicant may file 
when the Office can issue any number of rejections and improper final 
rejections.
    Response: In this final rule, the Office has not placed an absolute 
limit on the number of continued examination filings. Rather, applicant 
is permitted to file the initial application, two continuing 
applications, and a request for continued examination in an application 
family, without any justification, and any third or subsequent 
continuing application or second or subsequent request for continued 
examination with a petition and a showing as why the amendment, 
argument, or evidence sought to be entered could not have been 
submitted earlier. Applicant may seek review of any improper finality 
of a rejection by filing a petition under Sec.  1.181, or of any 
improper rejection by filing a notice of appeal, a request for pre-
appeal brief conference, and an appeal brief.
    Comment 57: Several comments argued that examiners will have to 
review larger submissions because applicants will be forced to front-
load responses to every Office action with interviews, declarations and 
other evidence when the attorney's argument alone otherwise might have 
been sufficient. The comments argued that this would increase pendency. 
One comment predicted that the rule changes would decrease examiners' 
production because there would be ``more hard cases'' and ``less easy 
counts.'' Several comments stated that the rule changes would require 
applicant to respond to a first Office action by preparing what would 
be a de facto appeal brief with all of the arguments and evidence 
because applicant would only file the one permissible continuation or 
continuation-in-part application or request for continued examination 
as a last resort after appeal.
    Response: Section 1.78 as adopted in this final rule permits an 
applicant to file two continuing applications plus one request for 
continued examination in an application family, without any 
justification. Thus, the changes adopted in this final rule do not 
require applicant to respond to a first Office action by preparing what 
would be a de facto appeal brief with all of the arguments and 
evidence. Nevertheless, the examination will be more efficient when 
applicant submits a fully responsive reply to each Office action so 
that the examiner will have the information, including amendments, 
arguments, and evidence, to determine the patentability sooner rather 
than later. Even prior to the changes being adopted in this final rule, 
applicants have been required to file a fully responsive reply to an 
Office action. See Sec. Sec.  1.111(b) and (c). A change to the rules 
of practice that encourages applicants to submit complete, rather than 
piecemeal, replies will advance prosecution to final disposition with a 
minimum number of Office actions, continuing applications, and requests 
for continued examination. Such change streamlines the examination 
process, thereby benefiting both applicants and the Office.
    Comment 58: A number of comments argued that continuation or 
continuation-in-part applications and requests for continued 
examination are needed so that applicants can submit prior art that is 
discovered after the prosecution is closed (e.g., through international 
search reports or foreign search reports), and amend the claims in view 
of late newly-discovered art. Several comments suggested that the 
Office should permit applicants to file a request for continued 
examination without a petition and showing to submit newly discovered 
prior art, and art cited by the U.S. International Searching Authority 
similar to art cited by a foreign patent office, because otherwise 
applicants would be penalized due to PCT administrative backlogs. One 
comment sought clarification in the situation where an applicant wishes 
to withdraw an application from issue to submit new art for 
consideration and a continuation application has been filed.
    Response: Applicant is not required to file a continuation or 
continuation-in-part application or a request for continued examination 
in order to submit prior art discovered after the prosecution is closed 
or an amendment in view of the late discovered art. The Office recently 
proposed changes to information disclosure statement (IDS) 
requirements. See Changes To Information Disclosure Statement 
Requirements and Other Related Matters, 71 FR 38808 (July 10, 2006), 
1309 Off. Gaz. Pat. Office 25 (Aug. 1, 2006) (proposed rule) 
(hereinafter ``Information Disclosure Statement Proposed Rule''). The 
proposed changes

[[Page 46765]]

(if adopted) would permit applicant to submit an IDS after a first 
Office action on the merits, but before the mailing date of a notice of 
allowability or a notice of allowance under Sec.  1.311, if applicant 
files the IDS with the certification under Sec.  1.97(e)(1) and a copy 
of the foreign search report, or an explanation under proposed Sec.  
1.98(a)(3)(iv) and a non-cumulative description under proposed Sec.  
1.98(a)(3)(v). Applicant would also be permitted to submit an IDS after 
allowance, but before the payment of the issue fee, if applicant files 
the IDS with a patentability justification under proposed Sec.  
1.98(a)(3)(vi), including any appropriate amendments to the claims. 
Applicant would be permitted to submit an IDS after the payment of the 
issue fee if applicant files a petition to withdraw from issue pursuant 
to Sec.  1.313(c)(1), the patentability justification under proposed 
Sec.  1.98(a)(3)(vi)(B), and an amendment to the claims. Prior to the 
effective date of any final rule based upon the Information Disclosure 
Statement Proposed Rule, applicant may submit an IDS after the close of 
prosecution with a petition under Sec.  1.183 if the IDS complies with 
the applicable requirements set forth in the Information Disclosure 
Statement Proposed Rule for such an IDS.

B. Treatment of Third and Subsequent Continuation or Continuation-In-
Part Applications

    Comment 59: Several comments supported the rule changes that permit 
one continued examination filing without any justification. A number of 
comments, however, suggested that the Office should permit more than 
one continued examination filing without requiring a petition and 
showing. The comments suggested the following without a petition and 
showing: (1) At least two continuation or continuation-in-part 
applications; (2) at least three continuation or continuation-in-part 
applications; (3) three to six continued examination filings; (4) three 
to five applications per application family; (5) only one patent to be 
issued from a chain of continuation applications; (6) unlimited number 
of continuation applications coupled with a requirement for a 
patentability report in the third or subsequent continuation 
application or a prior art search and compliance with the requirements 
under 35 U.S.C. 112; (7) two requests for continued examination, but 
only one continuation or continuation-in-part application; (8) at least 
one request for continued examination per application; (9) more than 
one request for continued examination per application; and (10) two or 
three requests for continued examination per application. Several 
comments suggested that the Office should permit more than one 
continuation or continuation-in-part application if the applications 
are filed within a reasonable time period (e.g., one to eight years 
from the earliest filing date claimed). One comment suggested that the 
Office should permit requests for continued examination filed within 
three years of the filing date if applicant has filed a petition to 
make special for accelerated examination. One comment suggested that 
the Office should permit applicant to file a request for continued 
examination, but allow the examiner to refuse the request for continued 
examination if the first action can be made final. One comment 
suggested that the Office should eliminate all continuing applications 
except for divisional applications. One comment proposed that the 
Office should eliminate all continuing applications, but permit 
requests for continued examination. One comment suggested that the 
limitation on the number of continued examination filings should not 
apply to divisional applications and requests for continued 
examination.
    Response: The Office has modified the proposed provisions that 
permit applicant to file one continuation or continuation-in-part 
application or request for continued examination without any 
justification. Under this final rule, applicant may file two 
continuation or continuation-in-part applications plus one request for 
continued examination in an application family, without any 
justification. Applicant may also file any third or subsequent 
continuation or continuation-in-part application or second or 
subsequent request for continued examination with a petition and 
showing. The changes being adopted in this final rule will permit the 
Office to focus its patent examining resources on examining new 
applications, and thus reduce the backlog of unexamined applications 
and improve pendency for all applications. Permitting more than two 
continuation or continuation-in-part applications and more than one 
request for continued examination in an application family without any 
justification would significantly decrease the effectiveness of the 
changes being adopted in this final rule. These final rule requirements 
for seeking a third or subsequent continuation or continuation-in-part 
application will not impact the vast majority of the applications.
    A time limit requirement for filing continuing applications and 
requests for continued examination would not be desirable because it 
would encourage applicants to file an unlimited number of continued 
examination filings before the time period expires. Furthermore, a time 
limit would preclude an applicant from filing appropriate continued 
examination filings after the time period expires. Additionally, this 
suggested strategy would also disproportionately impact applications in 
certain technologies (e.g., biotechnology) that have long prosecutions.
    Requiring a patentability report or a prior art search in a 
continuation application would not increase efficiency in the 
examination of the initial application. If applicant submits the 
information earlier in the initial application, applicant most likely 
would not need to file a third or subsequent continuing application 
because the examiner would have all of the relevant information to make 
the patentability determination in the initial application.
    The Office recognizes there are appropriate reasons for filing 
continued examination filings. As a result, the Office did not place an 
absolute limit on the number of continued examination filings. If the 
prior-filed application was subject to a requirement for restriction, 
applicant may file a divisional application directed to a non-elected 
invention that has not been examined. The divisional application need 
not be filed during the pendency of the application subject to a 
requirement for restriction, as long as the copendency requirement of 
35 U.S.C. 120 is met. See Sec.  1.78(d)(1)(ii). Therefore, the changes 
being adopted in this final rule appropriately balance the need to 
reduce the large and growing backlog of unexamined patent applications 
and make the patent examination process more effective.
    Comment 60: Several comments expressed concerns that there would be 
an added economic burden on applicants, particularly small entities, to 
pursue additional continued examination filings due to the new petition 
process, and that the economic burden will effectively be a bar to many 
applicants. The comments stated that even when an additional continued 
examination filing is completely justified, applicants will suffer 
undue hardship and will likely be deterred from even attempting to 
request any additional continued examination filing because of the 
expense and time involved to review and prepare the petition. One 
comment suggested that the petition process under Sec. Sec.  
1.78(d)(1)(vi) and 1.114(g) will have a disparate effect on small 
entities. Several comments suggested that the

[[Page 46766]]

Office should provide an exception for filing additional continued 
examination filings to applicants who are small entities and those that 
qualify for financial hardship. One comment further suggested that the 
Office should provide the exception for five years.
    Response: The Office notes the concerns expressed in the public 
comment regarding the proposed changes to Sec. Sec.  1.78(d) and 
1.114(g) that would permit an applicant to file one continuation 
application, continuation-in-part application, or request for continued 
examination, without any justification. The Office has made 
modifications to the proposed provisions such that this final rule 
permits an applicant to file two continuation applications or 
continuation-in-part applications, plus a single request for continued 
examination in an application family, without any justification. Under 
this final rule, an applicant may also file a divisional application of 
a prior-filed application for the claims to a non-elected invention 
that was not examined if the application was subject to a requirement 
for restriction. The divisional application need not be filed during 
the pendency of the application subject to a requirement for 
restriction, as long as the copendency requirement of 35 U.S.C. 120 is 
met. This final rule also permits applicant to file two continuation 
applications of a divisional application plus a request for continued 
examination in the divisional application family, without any 
justification. Applicant may file any additional continuation 
application or request for continued examination with a petition and 
showing.
    The changes to Sec. Sec.  1.78(d) and 1.114(g) adopted in this 
final rule apply to all applicants, regardless of whether they are 
individuals, small businesses or large multinational corporations. 
These changes do not disproportionately affect individuals and small 
businesses. Applicants who seek to file a third or subsequent 
continuation or continuation-in-part application or a second or 
subsequent request for continued examination are required to file a 
petition under Sec.  1.78(d)(1)(vi) or 1.114(g) regardless of their 
status. The requirements for seeking a third or subsequent continuation 
or continuation-in-part application or a second or subsequent request 
for continued examination would only have affected 2.9 percent of the 
applications or requests for continued examination filed by a small 
entity in fiscal year 2006. The Office notes that a vast majority of 
applicants do not file more than two continuation or continuation-in-
part applications and more than one request for continued examination 
in an application family. Therefore, the $400 petition fee and the 
showing requirement will impact only a small minority of applicants.

C. Treatment of Second and Subsequent Requests for Continued 
Examination

    Comment 61: Several comments supported the changes to Sec.  1.114. 
A number of comments, however, objected to the changes and suggested 
that the Office should permit applicants to file requests for continued 
examination without a petition and showing. The comments provided the 
following reasons: (1) Requests for continued examination are different 
from continuing applications because requests for continued examination 
require applicant to advance prosecution and would not cause the Office 
to issue multiple patents to the same invention; (2) requests for 
continued examination are not continuation applications, but rather are 
the same application; (3) requests for continued examination help 
applicants to deal with deficiencies in the examination process and 
provide a more efficient, effective and cheaper procedure to advance 
prosecution and have art considered than the appeal, petition or 
reissue process; (4) limiting applicants to one request for continued 
examination without a petition would lead to more filings of 
continuation applications and petitions; (5) due to the changes in 
Sec.  1.75, the Office would issue more final Office actions with new 
grounds of rejection, which would necessitate the filing of more 
requests for continued examination; and (6) applicants would file more 
appeals, and thus the pendency of applications would increase.
    Response: The Office has modified the proposed provisions to 
provide that an applicant may file a request for continued examination 
in an application family, without a petition and showing. An 
application family includes the initial application and its 
continuation or continuation-in-part applications. Under this final 
rule, applicant may also file a request for continued examination in a 
divisional application family, without a petition and showing. A 
divisional application family includes the divisional application and 
its continuation applications. The provisions of Sec.  1.78(d)(1) are 
independent of the provisions of Sec.  1.114. Therefore, the filing of 
a request for continued examination does not preclude an applicant from 
filing two continuation or continuation-in-part applications. 
Similarly, the filing of a continuation or continuation-in-part 
application does not preclude an applicant from filing a request for 
continued examination.
    When applicant files a request for continued examination, the 
prosecution of the application is reopened and the examiner conducts 
another substantive examination on the claims present in the 
application. Consequently, similar to continuation or continuation-in-
part applications, requests for continued examination divert the 
Office's patent examining resources from the examination of new 
applications and contribute to the backlog of unexamined applications. 
The request for continued examination practice should not be used as a 
substitute for the appeal, petition or reissue process. If the 
applicant disagrees with the examiner's rejections, then the applicant 
should pursue the appeal process as a means to more efficiently resolve 
the disagreement.
    In addition, under the Office's new optional streamlined 
continuation procedure, an applicant may request that a continuation 
application be placed on an examiner's amended (Regular Amended) docket 
(see discussions of Sec. Sec.  1.78(d)(1)(i) and 1.114) which would be 
picked up for action faster than an application placed on the 
examiner's new continuing application (New Special) docket. By 
requesting that the two continuation applications permitted under Sec.  
1.78(d)(1)(i) be treated under the optional streamlined continuation 
application procedure, an applicant may obtain the benefits of faster 
processing similar to having a second and third request for continued 
examination without a petition under Sec.  1.114(g).
    Comment 62: One comment sought clarification on whether the changes 
to Sec. Sec.  1.78 and 1.114 being adopted in this final rule apply to 
reissue applications.
    Response: The changes to Sec. Sec.  1.78 and 1.114 being adopted in 
this final rule apply to reissue applications. Under this final rule, 
applicant may file two reissue continuation applications plus a request 
for continued examination in the reissue application family, without 
any justification. Benefit claims under 35 U.S.C. 120, 121, or 365(c) 
in the application for patent that is being reissued will not be taken 
into account in determining whether a continuing reissue application 
claiming the benefit under 35 U.S.C. 120, 121, or 365(c) of the reissue 
application satisfies one or more of the conditions set forth in 
Sec. Sec.  1.78(d)(1)(i) through 1.78(d)(1)(vi). For example, even if 
the application for the original patent was a second continuation 
application, applicant may still file two reissue continuation

[[Page 46767]]

applications. However, an applicant may not use the reissue process to 
add to the original patent benefit claims under 35 U.S.C. 120, 121, or 
365(c) that do not satisfy one or more of the conditions set forth in 
Sec. Sec.  1.78(d)(1)(i) through 1.78(d)(1)(vi) to the original patent, 
if the application for the original patent was filed on or after 
November 1, 2007.
    Comment 63: One comment suggested that the examiner should not make 
any new rejections in a request for continued examination, unless the 
amendment to the claims raises new issues.
    Response: When applicant files a request for continued examination 
in compliance with Sec.  1.114, the prosecution of the application is 
reopened and the examiner will consider the amendment, argument, or 
evidence submitted by the applicant. The examiner will conduct another 
substantive examination, consistent with providing ``for the continued 
examination of application'' under 35 U.S.C. 132(b). Limiting the 
examiner's ability to conduct a patentability determination after the 
filing of a request for continued examination would not result in 
efficiency in the examination process.
    Comment 64: One comment argued that it would be inconsistent to 
permit the filing of a request for continued examination in a prior-
filed application after a continuation application is filed, but to not 
permit the filing of a continuation application of an application that 
has a request for continued examination filed therein. Another comment 
suggested that the Office should permit an applicant to file a 
continuation application even though a request for continued 
examination had been filed in the prior-filed application.
    Response: The Office has modified the proposed provisions to 
provide that an applicant may file a request for continued examination 
in an application family, without a petition and showing. The 
provisions of Sec.  1.78(d)(1) are independent of the provisions of 
Sec.  1.114. Therefore, the filing of a request for continued 
examination does not preclude an applicant from first filing two 
continuation or continuation-in-part applications. Likewise, the filing 
of a continuation or continuation-in-part application does not preclude 
an applicant from first filing a request for continued examination. Put 
differently, under this final rule, applicant may file a continuation 
application of an application in which a request for continued 
examination has already been filed. Applicant may also file a request 
for continued examination in a prior-filed application after a 
continuation application has been filed.

D. Petitions Related to Additional Continuation Applications, 
Continuation-In-Part Applications, and Requests for Continued 
Examination

    Comment 65: A number of comments were critical of the showing 
requirement set forth in Sec. Sec.  1.78(d)(1) and 1.114. One comment 
argued that the required showing is a per se limit on the number of 
continuation or continuation-in-part applications and requests for 
continued examination. Several comments stated that the standard under 
Sec. Sec.  1.78(d)(1) and 1.114 is a hindsight standard. The comments 
argued that except for rare instances when evidence was not in 
existence prior to filing the additional continuing examination filing, 
the Office could almost always conclude, in hindsight, that the 
amendment, argument, or evidence sought to be entered could have been 
previously submitted. One comment argued that the showing under 
Sec. Sec.  1.78(d)(1) and 1.114(g) is too stringent and unrealistic 
given the practicalities of conventional and reasonable patent 
prosecution practice and the interests of patent applicants. Several 
other comments described the showing as exceptionally high, onerous, 
impossible to meet, restrictive, and ambiguous. Furthermore, several 
comments asserted that the rule changes required applicants to be aware 
of all possible prior art. Several other comments stated that the 
required showing set forth in Sec. Sec.  1.78(d)(1) and 1.114 appears 
difficult to meet for any amendment submitted with an application that 
is not a continuation-in-part application, indicating that it is hard 
to imagine how one would prove that an amendment or argument ``could 
not have been submitted'' in the absence of new matter. One comment 
objected to the required showing under Sec. Sec.  1.78(d)(1) and 1.114 
because the purpose of filing an additional continuation or 
continuation-in-part application or a request for continued examination 
may be to do something other than present a new argument, evidence or 
amendment, such as protect a different aspect of the invention revealed 
by research and development subsequent to an initial application 
filing. One comment stated that given enough time and effort an 
applicant will almost always be able to come up with some reason why 
the amendment, argument, or evidence could not have been previously 
submitted as required by Sec. Sec.  1.78(d)(1) and 1.114 and that this 
requirement merely adds a layer of bureaucracy. One comment in support 
of the showing under Sec. Sec.  1.78(d)(1) and 1.114 stated that it is 
a sensible compromise that does not ban additional continued 
examination filings, but requires applicants in essence to show good 
cause for additional continued examination filings. Several comments in 
support of the showing stated that the proposed rules accommodate the 
legitimate uses of continuations, limit abuses that can harm the 
competitive process, and promote the patent system's ability to provide 
incentives to innovate by reducing pendency.
    Response: The Office notes the concerns expressed in the public 
comment regarding the proposed provisions that would require a petition 
and showing if an applicant files more than one continued examination 
filing (a continuation application, a continuation-in-part application, 
or a request for continued examination). The Office has made 
modifications to these proposed changes such that this final rule 
permits an applicant to file two continuation applications or 
continuation-in-part applications, plus a single request for continued 
examination in an application family, without any justification. Under 
this final rule, an applicant may also file a divisional application of 
an application for the claims to a non-elected invention that was not 
examined if the application was subject to a requirement for 
restriction. The divisional application need not be filed during the 
pendency of the application subject to a requirement for restriction, 
as long as the copendency requirement of 35 U.S.C. 120 is met. This 
final rule also permits applicant to file two continuation applications 
of a divisional application plus a request for continued examination in 
the divisional application family, without any justification. Applicant 
may file any additional continuation application or request for 
continued examination with a petition and showing. Therefore, given the 
multiple opportunities for applicant to submit amendments, arguments, 
or evidence, it is appropriate to require an applicant to justify why 
an amendment, argument, or evidence sought to be entered could not have 
been submitted earlier when filing any third or subsequent continuation 
application, continuation-in-part application, or second or subsequent 
request for continued examination. The Office considers the standard 
set forth in Sec. Sec.  1.78(d)(1)(vi) and 1.114(g) to be an 
appropriate balance of the interests of applicants and the need for a 
better

[[Page 46768]]

focused and effective examination process to reduce the large and 
growing backlog of unexamined applications.
    Applicants and practitioners have a duty to refrain from submitting 
an application or other filing to cause unnecessary delay or needless 
increase in the cost of prosecution before the Office. See Sec.  
10.18(b)(2). Applicants also have a duty throughout the prosecution of 
an application to make a bona fide attempt to advance the application 
to final agency action. See Changes to Practice for Continuing 
Applications, Requests for Continued Examination Practice, and 
Applications Containing Patentably Indistinct Claims, 71 FR at 49, 1302 
Off. Gaz. Pat. Office at 1319. Applicant should be prepared to 
particularly point out and distinctly claim what the applicant regards 
as his or her invention. Furthermore, the examination process is more 
efficient and the quality of the patentability determination will 
improve when applicant presents the desired claims, amendments, 
arguments and evidence as early as possible in the prosecution. The 
changes to Sec. Sec.  1.78 and 1.114 in this final rule do not require 
an applicant to be aware of all possible prior art to meet the showing 
under Sec. Sec.  1.78(d)(1)(vi) and 1.114(g), but applicant is required 
to conduct a prior art search for filing an examination support 
document under Sec.  1.265. Nor do these changes add to applicant's 
existing duties under Sec.  1.56(a) to disclose to the Office all 
information known to the applicant to be material to patentability, and 
under 37 CFR Part 10.
    Comment 66: One comment asserted that the Office will not achieve 
its goal of reducing the number of filings of continuation applications 
because an applicant could easily show why the amendment, argument, or 
evidence could not have been previously submitted when the subject 
matter of the claims in the continuation application is different from 
the subject matter of the claims of the initial application.
    Response: The submission of an amendment to the claims or new 
claims to different subject matter alone will not be sufficient to meet 
the showing requirement under Sec.  1.78(d)(1)(vi). Applicant must 
provide a satisfactory showing that the amendment, argument, or 
evidence sought to be entered could not have been previously submitted 
during the prosecution of the initial application, two continuation 
applications, and the request for continued examination.
    Comment 67: One comment stated that the required showing under 
Sec. Sec.  1.78(d) and 1.114 might have far-reaching implications that 
extend outside the patent process. Several comments expressed concerns 
that the showing may require applicants to disclose highly sensitive 
business information such as business strategies, and to alert their 
competitors as to how the applicants plan to gain a competitive edge. 
The comments further expressed concerns that the petition procedure may 
also invoke attorney-client privilege.
    Response: Applicants or patent owners often present sensitive 
business information to the Office, such as a showing of unavoidable 
delay in a petition to revive under Sec.  1.137(a) or a petition to 
accept late payment of a maintenance fee under Sec.  1.378(b). The 
Office has procedures in place for applicants and patent owners to 
submit trade secrets, proprietary material, and protective order 
material and to prevent unnecessary public disclosure of the material. 
See MPEP Sec. Sec.  724-724.06. If it is necessary for an applicant to 
disclose sensitive business information to the Office to meet the 
showing under Sec.  1.78(d)(1)(vi) or 1.114(g), applicant may submit 
the information in compliance with the procedures set forth in MPEP 
Sec. Sec.  724-724.06 (e.g., the information must be clearly labeled as 
such and be filed in a sealed, clearly labeled, envelope or container).
    Comment 68: One comment stated that the petitions under Sec. Sec.  
1.78(d)(1) and 1.114 would be scrutinized in court, creating a 
substantial increase in time and resources devoted to litigating and 
enforcing otherwise valid patent rights. One comment expressed concern 
that the petitions under Sec. Sec.  1.78(d)(1) and 1.114 are unlikely 
to be granted and are likely to be the subject of an attack in 
litigation. A number of comments asserted that applicants would be 
subject to a higher potential for allegations of inequitable conduct. 
Additionally, one comment argued that the proposed rule changes would 
increase the frequency of malpractice litigation.
    Response: The rules adopted in this final rule require applicants 
to prosecute their applications with reasonable diligence and 
foresight. The submission of a showing as to why an amendment, argument 
or evidence sought to be entered could not have been submitted earlier 
does not expose an applicant to a greater risk of inequitable conduct 
or litigation. The failure to disclose material information, or an 
affirmative misrepresentation of a material fact or submission of false 
material information or statements, coupled with an intent to deceive 
or mislead the Office, constitutes inequitable conduct. The simple 
submission of a showing as to why an amendment, argument or evidence 
sought to be entered could not have been submitted earlier does not by 
itself raise such intent. If an applicant acts with candor and good 
faith in dealing with the Office, there should be no increased risk 
that the applicant will be accused of inequitable conduct. Similarly, 
if patent practitioners abide by the standards of professional conduct 
expected of practitioners in their relationships with their clients, 
and comply with the requirements of the patent statutes and rules, 
there should be no reason for increased exposure to malpractice suits.
    Comment 69: Several comments suggested that the Office should adopt 
an alternate standard for additional continued examination filings in 
place of the standard set forth in Sec. Sec.  1.78(d)(1) and 1.114. 
Some of the comments suggested the following alternatives: (1) A 
reasonable diligence standard; (2) a certification by a practitioner 
that it is necessary for the inventor to be adequately protected; (3) 
the ``unduly interferes'' standard as set forth in the former Sec.  
1.111(b); (4) a requirement that the submission be a bona fide attempt 
to advance prosecution; (5) an explanation of the need for the 
continued examination filing; (6) a reasonable justification standard; 
(7) a reasonable under the circumstances standard; or (8) a good cause 
standard. One of the comments stated that a good cause standard would 
not place an undue burden on the Office or prejudice the public. 
Additionally, the comment requested that an application filed for good 
cause should not count toward the single continued examination filing 
as a matter of right.
    Response: The Office considers the standard that the amendment, 
argument or evidence sought to be entered could not have been 
previously submitted set forth in Sec. Sec.  1.78(d)(1)(vi) and 
1.114(g) appropriate for an additional continued examination filing. 
The standard set forth in Sec. Sec.  1.78(d)(1)(vi) and 1.114(g) as 
adopted in this final rule (``a showing that the amendment, argument, 
or evidence sought to be entered could not have been submitted 
[earlier]'') is more definite than the alternatives suggested in the 
comments (e.g., ``good cause'' and ``reasonable under the 
circumstances'') and other standards set forth in the patent statutes 
(see e.g., Smith v. Mossinghoff, 671 F.2d 533, 538, 213 U.S.P.Q. 977, 
982 (DC Cir. 1982) (noting the absence of guidance concerning the 
meaning of the term ``unavoidable'' in 35 U.S.C. 133)). The comments do 
not provide an explanation as to why any of

[[Page 46769]]

these alternatives would be a more effective standard or more definite. 
Furthermore, Sec. Sec.  1.78(d)(1) and 1.114(g) as adopted in this 
final rule do not set an absolute limit on the number of continued 
examination filings. Applicants are permitted to file two continuation 
or continuation-in-part applications and one request for continued 
examination without any justification. Applicants are also permitted to 
file any third or subsequent continuation or continuation-in-part 
application or second or subsequent request for continued examination 
with a petition and showing. If an amendment, argument, or evidence 
could have been submitted during the prosecution of the initial 
application, two continuing applications, or a request for continued 
examination, applicant must present such submission earlier rather than 
wait to submit it later in a third or subsequent continuation or 
continuation-in-part application or in a request for continued 
examination. Thus, the required showing is an appropriate standard.
    Finally, as discussed further in this final rule, the Office may 
grant relief ``in an extraordinary situation'' in which ``justice 
requires'' even if the situation does not technically meet the standard 
that the amendment, argument or evidence sought to be entered could not 
have been previously submitted. See Sec.  1.183. The Office, however, 
does not anticipate granting petitions under Sec.  1.78(d)(1)(vi) on a 
basis other than a showing that the amendment, argument or evidence 
sought to be entered could not have been previously submitted.
    Comment 70: Several comments suggested that the changes to Sec.  
1.78 should only be temporary so that the Office may assess the impact 
of the changes before adopting the rule. One comment also suggested 
that if the Office adopts the rule changes, the Office should eliminate 
the changes once the backlog decreases.
    Response: Unrestricted continued examination filings and 
duplicative applications that contain patentably indistinct claims are 
significantly hindering the Office's ability to examine new 
applications to such an extent that it is necessary for the Office to 
adopt and implement the changes to these practices. After the 
implementation of the changes being adopted in this final rule, the 
Office will re-evaluate the rules of practice to determine what, if 
any, additional changes are necessary.
    Comment 71: Several comments suggested that Sec. Sec.  1.78(d)(1) 
and 1.114 should be revised from ``a showing as to why the amendment, 
argument, or evidence presented could not have been previously 
submitted'' to ``a showing as to why the new claim, amendment, 
argument, or evidence presented could not have been previously 
submitted'' to resolve any potential ambiguity in the rules.
    Response: The Office notes the comments' concern for ambiguity in 
the language of the rules. The phrase, ``a showing * * * that the 
amendment, argument, or evidence sought to be entered could not have 
been submitted'' (emphasis added) inherently encompasses a showing as 
to why a new claim could not have been previously submitted. A new 
claim presented in a continuing application is considered to be an 
amendment to the claims of the prior-filed application. Thus, by using 
the word ``amendment'' in the standard of Sec. Sec.  1.78(d)(1)(vi) and 
1.114(g), the Office intended to capture new claims sought to be 
introduced in a third or subsequent continuation or continuation-in-
part application or second or subsequent request for continued 
examination.
    Comment 72: One comment recommended that the Office should only 
require a petition and showing if the claims are presented more than 
two years after the earliest filing date claimed.
    Response: Sections 1.78(d)(1) and 1.114 as adopted in this final 
rule provide applicant sufficient opportunities to present claims 
during the prosecution of the initial application, two continuing 
applications, and a request for continued examination in an application 
family without a petition under Sec.  1.78(d)(1)(vi) or 1.114(g). The 
prosecution of these applications and the request for continued 
examination, most likely, would extend more than two years from the 
earliest claimed filing date. Therefore, the suggestion, if adopted, 
would likely increase the number of applicants who would be required to 
file a petition and showing.
    Comment 73: Several comments proposed an exception to the rule 
changes to permit applicant to file a continuing application or a 
request for continued examination as a matter of right, without 
requiring a petition and showing, if the prior application is abandoned 
prior to examination.
    Response: As suggested, the Office has made modifications to the 
proposed provisions to provide that an applicant may file a 
continuation or continuation-in-part application without any 
justification in certain situations in which the prior-filed 
application was abandoned prior to examination. Section 1.78(d)(1)(v) 
as adopted in this final rule provides that if an applicant files a 
continuation or continuation-in-part application to correct 
informalities rather than completing an application for examination 
under Sec.  1.53 (i.e., the prior-filed application became abandoned 
due to the failure to timely reply to an Office notice issued under 
Sec.  1.53(f)), the applicant may file ``one more'' continuation or 
continuation-in-part application without a petition and showing under 
Sec.  1.78(d)(1)(vi). Thus, applicant may file a continuation or 
continuation-in-part application to correct informalities rather than 
completing an application for examination under Sec.  1.53. The prior-
filed nonprovisional application, however, must be entitled to a filing 
date and have paid therein the basic filing fee within the pendency of 
the application. See Sec.  1.78(d)(2).
    Comment 74: Several comments suggested the Office should include 
exceptions to the petition requirement of Sec. Sec.  1.78(d)(1) and 
1.114 to permit applicant to file a continuing application or a request 
for continued examination as a matter of right, without requiring a 
petition and showing, in the following situations: (1) Some of the 
claims in the prior-filed application have been allowed and the 
continuation application contains only claims that were rejected in the 
prior-filed application; (2) the continuation application contains 
claims to an unclaimed invention disclosed in the prior-filed 
application; (3) the continuing application is claiming an independent 
and distinct invention; (4) the continuing application claims species 
or subgenus that falls within a generic claim that has been allowed or 
issued in one of the prior-filed applications; (5) the continued 
examination filing is filed for the purposes of submitting newly 
discovered prior art or amendments or evidence in view of the newly 
discovered prior art; (6) the continued examination filing is filed 
after an unsuccessful appeal; (7) a divisional application of an 
application that was subject to a restriction requirement is filed for 
the purposes of claiming the non-elected inventions; (8) the 
continuation application includes claims that were canceled in the 
prior-filed application; (9) the applicant certifies that the filing is 
done in good faith to advance prosecution and without deceptive intent; 
(10) the continued examination filing is filed for submitting evidence 
or an amendment to overcome a final rejection; (11) a continuation or 
continuation-in-part is filed to overcome a lack of utility rejection; 
(12) the continued

[[Page 46770]]

examination filing is filed to submit a declaration under Sec.  1.131 
or 1.132; (13) the continued examination filing is filed to submit data 
or other evidence not available for submission in the parent 
application to obviate a rejection under 35 U.S.C. 101 or 112, ] 1 
(e.g., for lack of utility or enablement); (14) the continued 
examination filing is filed to respond to an examiner's request for 
additional information; (15) the continued examination filing is filed 
to respond to a new ground of rejection; (16) the prior-filed 
application was abandoned in favor of a continuing application that is 
filed using the Office electronic filing system; and (17) a request for 
continued examination is filed via the Office electronic filing system. 
One comment stated that if Congress does not eliminate 35 U.S.C. 
135(b)(2), the need to copy claims from published applications should 
be exempt from the limit of continued examination filings in an 
application as a matter of right.
    Response: The Office notes the concerns expressed in the public 
comment regarding the proposed changes to Sec. Sec.  1.78(d)(1) and 
1.114 that would have required applicant to file a petition and showing 
for a second or subsequent continuation or continuation-in-part 
application or request for continued examination. The Office has 
modified these proposed changes such that this final rule permits an 
applicant to file two continuation applications or continuation-in-part 
applications, plus a single request for continued examination in an 
application family, without any justification.
    Other than the situations provided in Sec. Sec.  1.78(d)(1)(iv) and 
(d)(1)(v), this final rule permits that a third or subsequent 
continuing application or any second or subsequent request for 
continued examination to be filed with a petition and a showing as to 
why the amendment, argument, or evidence sought to be entered could not 
have been previously submitted. Sections 1.78(d)(1)(iv) and (d)(1)(v) 
provide that applicant may file ``one more'' continuation or 
continuation-in-part application without a petition and showing in 
certain situations. Specifically, Sec.  1.78(d)(1)(iv) pertains to the 
situation where an applicant files a bypass continuation or 
continuation-in-part application rather than paying the basic national 
fee (entering the national stage) in an international application in 
which a Demand for international preliminary examination (PCT Article 
31) has not been filed, and the international application does not 
claim the benefit of any other nonprovisional application or 
international application designating the United States of America. See 
the discussion of Sec.  1.78(d)(1)(iv). Section 1.78(d)(1)(v) pertains 
to the situation where an applicant files a continuation or 
continuation-in-part application to correct informalities rather than 
completing an application for examination under Sec.  1.53. See the 
discussion of Sec.  1.78(d)(1)(v).
    The Office will decide petitions under Sec. Sec.  1.78(d)(1)(vi) 
and 1.114(g) based on their substantive argument and the facts in the 
record and apply the standard in a consistent manner. There are no 
situations that will result in a per se or pro forma grant of a 
petition under Sec.  1.78(d)(1)(vi) or 1.114(g). Whether specific 
situations would be a sufficient showing under Sec.  1.78(d)(1)(vi) or 
1.114(g) is discussed in the responses to subsequent comments.
    Comment 75: Several comments opposed the $400 fee for filing a 
petition under Sec. Sec.  1.78(d)(1) and 1.114. The comments indicated 
that the proposed petition fee of $400 is unnecessarily high, 
especially in view of the filing fees. Furthermore, the comments argued 
that it is unfair to require the submission of a costly fee and a time-
consuming petition regardless of the reason for filing the continuing 
application or request for continued examination. One other comment 
stated that the proposed petition fee does not cover the amount of work 
required to determine if applicant's showing is sufficient to meet the 
requirements in Sec. Sec.  1.78(d)(1) and 1.114. Another comment 
questioned why an applicant must pay a petition fee of $400 when filing 
an additional continuation-in-part application simply to add new 
matter.
    Response: The Office considers $400 to be an appropriate fee for 
filing a petition under Sec.  1.78(d)(1)(vi) or 1.114(g). 35 U.S.C. 
41(d) authorizes the Director to establish fees to recover the 
estimated average cost to the Office for handling, reviewing and 
deciding petitions. The Office has determined that the average cost to 
the Office for handling, reviewing and deciding the petitions under 
Sec. Sec.  1.78(d)(1)(vi) and 1.114(g) will be at least $400. As 
previously discussed, applicants most likely will be able to avoid the 
requirements for filing a petition and the required fee if applicants 
diligently prosecute applications (including the continuing 
applications and a request for continued examination permitted under 
Sec. Sec.  1.78(d)(1) and 1.114(f) without any petition). If an 
applicant desires to file an application simply to claim new subject 
matter, the applicant may file a new application (rather than a 
continuation-in-part application) without claiming the benefit of the 
prior-filed applications and avoid paying the $400 petition fee. As 
discussed previously, claims to new subject matter will not be entitled 
to any benefit of the prior-filed application that does not provide 
support under 35 U.S.C. 112, ] 1, for the claimed subject matter and 
the patent term of any resulting patent of the continuation-in-part 
application would be measured from the filing date of the prior-filed 
application.
    Comment 76: One comment requested that the Office waive the 
requirement for a petition fee if applicant submits new art from a 
foreign search report or related application or files an amendment in 
response to new arguments made by the examiner.
    Response: A petition, the appropriate showing, and the fee set 
forth in Sec.  1.17(f) are required under Sec.  1.78(d)(1)(vi) or 
1.114(g) when applicant files a third or subsequent continuing 
application or a second or subsequent request for continued examination 
regardless of the reason for such a filing. In addition, a request to 
submit new art from a foreign search report or related application is 
not likely to be a sufficient showing under Sec.  1.78(d)(1)(vi) or 
1.114(g) (see discussion relating to the filing of continuing 
applications and requests for continued examination to obtain 
consideration of an information disclosure statement). Likewise, the 
mere fact that the examiner made new arguments or a new ground of 
rejection in a final Office action would not be considered a sufficient 
showing. The Office will decide each petition on a case-by-case basis 
focusing on whether the new ground of rejection in the final Office 
action could have been anticipated by the applicant.
    Comment 77: Several comments stated that there is no public notice 
of the criteria the Director will apply to meet the required showing 
under Sec.  1.78(d)(1) or 1.114. A number of comments sought 
clarification on what type of showing under Sec.  1.78(d)(1) or 1.114 
would be necessary to permit the filing of an additional continuing 
application or request for continued examination. A number of comments 
specifically sought clarification of the phrase, ``could not have been 
previously submitted,'' in Sec. Sec.  1.78(d)(1) and 1.114 regarding 
the satisfactory showing needed to be permitted to file an additional 
continuing application or request for continued examination. A number 
of other comments suggested that prior to the implementation of the 
final rule, the Office should publish

[[Page 46771]]

more specific guidelines such as a non-exclusive set of examples that 
would constitute a sufficient showing under Sec. Sec.  1.78(d)(1) and 
1.114. In addition, several comments requested that the Office provide 
an opportunity for public comment on the suggested guidelines.
    Response: As discussed previously, the standard set forth in 
Sec. Sec.  1.78(d)(1)(vi) and 1.114(g) as adopted in this final rule 
(``a showing that the amendment, argument, or evidence sought to be 
entered could not have been submitted [earlier]'') is more definite 
than the alternatives suggested in the comments (e.g., ``good cause'' 
and ``reasonable under the circumstances'') and other standards set 
forth in the patent statutes (see e.g., Smith v. Mossinghoff, 671 F.2d 
533, 538, 213 U.S.P.Q. 977, 982 (D.C. Cir. 1982) (noting the absence of 
guidance concerning the meaning of the term ``unavoidable'' in 35 
U.S.C. 133)). If an amendment, argument or evidence could be submitted 
during the prosecution of the initial application, two continuing 
applications, and a request for continued examination in an application 
family, applicant must present such an amendment, argument or evidence 
earlier rather than wait to submit it later in an additional continuing 
application or request for continued examination. Applicants should not 
rely upon the availability of additional continuing applications or 
requests for continued examination in prosecuting an application. The 
Office will determine on a case-by-case basis whether the applicant's 
showing as to why the amendment, argument or evidence sought to be 
entered could not have been submitted earlier is satisfactory. In 
addition to the showing submitted by the applicant, the Office may 
review the prosecution history of the initial application and the prior 
continuing applications or require additional information from the 
applicant in deciding a petition. The following are some factors that 
the Office may consider when deciding whether to grant a petition under 
Sec.  1.78(d)(1)(vi) or 1.114(g): (1) Whether applicant should file an 
appeal or a petition under Sec.  1.181 (e.g., to withdraw the finality 
of an Office action) rather than a continuing application or request 
for continued examination; (2) the number of applications filed in 
parallel or serially with substantially identical disclosures; and (3) 
whether the evidence, amendments, or arguments are being submitted with 
reasonable diligence.
    With respect to the first factor (whether applicant should be 
filing an appeal or a petition under Sec.  1.181 rather than a 
continuing application or request for continued examination), if the 
showing under Sec.  1.78(d)(1)(vi) or 1.114(g) relates to an issue that 
should be petitioned or appealed, the Office will likely not grant the 
petition for an additional continuing application or request for 
continued examination. Applicant should address any issues pertaining 
to inadequate examination by seeking review via a petition under Sec.  
1.181 or an appeal, rather than by filing a continuing application or 
request for continued examination.
    If the disagreement between the examiner and applicant is 
procedural in nature (e.g., an objection), then applicant should file a 
petition under Sec.  1.181. For example, an applicant should file a 
petition under Sec.  1.181 to request the withdrawal of the finality of 
an Office action when the finality was premature, or to review the 
examiner's refusal to enter an after-final amendment. The Office will 
likely not grant a petition under Sec.  1.78(d)(1)(vi) or 1.114(g) if 
applicant argues only that an amendment after final rejection should 
have been entered in the prior-filed application because the final was 
premature. Applicant should have addressed the non-entry in the prior-
filed application and not later in a petition under Sec.  
1.78(d)(1)(vi) or 1.114(g) for a continuing application or request for 
continued examination. If the issue goes to the merits of a rejection, 
applicant should file an appeal to the BPAI under 35 U.S.C. 134 and 
Sec.  41.31.
    With respect to the second factor (the number of applications filed 
in parallel or serially with substantially identical disclosures), the 
higher the number of applications with identical or substantially 
identical disclosures or the higher the number of applications in the 
chain of prior-filed copending applications, the more opportunities 
applicant had to present the amendment, argument or evidence. 
Accordingly, a petition under Sec.  1.78(d)(1)(vi) or 1.114(g) is less 
likely to be granted.
    With respect to the third factor (whether the evidence, amendments, 
or arguments are being submitted with reasonable diligence), the Office 
will focus on whether the evidence or data submitted with the petition 
to meet the showing under Sec.  1.78(d)(1)(vi) or 1.114(g) was 
presented in a reasonably diligent manner. This will take into account 
the condition of the application at the time of examination (e.g., 
whether the initial application was in proper form for examination by 
the time of the first Office action in the initial application or 
whether it was necessary to first issue Office actions containing 
rejections under 35 U.S.C. 112 or objections to have the application 
placed in proper form for examination), the consistency of the Office's 
position during prosecution (e.g., whether applicant received wholly 
new prior art rejections versus prior art rejections slightly modified 
to address the amendments), and the earnestness of the applicant's 
efforts to overcome outstanding rejections (e.g., whether replies fully 
addressed all of the grounds of rejection or objection in the Office 
actions, or whether amendments or evidence were submitted only when 
arguments were failing to persuade the examiner).
    Comment 78: One comment sought clarification as to whether a 
petition under Sec.  1.78(d)(1) would be available for ``involuntary'' 
divisional applications. Another comment suggested an applicant should 
be permitted to file any divisional application in response to a 
restriction requirement.
    Response: The Office notes the concerns expressed in the public 
comment regarding the proposed changes to Sec.  1.78(d)(1)(ii). The 
Office has modified this provision relative to the proposed changes 
such that Sec.  1.78(d)(1)(ii) as adopted in this final rule does not 
require a divisional application to be filed during the pendency of the 
application subject to a requirement for restriction, as long as the 
copendency requirement of 35 U.S.C. 120 is met. Under this final rule, 
applicant may file, without any justification, a divisional application 
containing only claims directed to a non-elected invention that has not 
been examined if the prior-filed application was subject to a 
requirement for restriction (an ``involuntary'' divisional 
application''). Applicant may also file two continuation applications 
and a request for continued examination in the divisional application 
family, without any justification. Furthermore, applicant may file a 
third or subsequent continuation application or a second or subsequent 
request for continued examination with a petition and showing.
    Comment 79: Several comments sought clarification on whether the 
Office will grant a petition under Sec.  1.78(d)(1) for filing a 
divisional application of an application that was subject to a 
restriction requirement for the purposes of claiming the non-elected 
inventions.
    Response: As previously discussed, the Office has modified the 
provisions of Sec.  1.78(d)(1)(ii) relative to the proposed changes. In 
this final rule, Sec.  1.78(d)(1)(ii) does not require a divisional 
application to be filed during

[[Page 46772]]

the pendency of the application subject to a requirement for 
restriction, as long as the copendency requirement of 35 U.S.C. 120 is 
met. This final rule provides that an applicant may file a divisional 
application directed to each non-elected invention that has not been 
examined if the prior-filed application is subject to a requirement for 
restriction. Section Sec.  1.78(d)(1)(iii) as adopted in this final 
rule also permits applicant to file two continuation applications of a 
divisional application, plus a request for continued examination in the 
divisional application family, without any justification. Furthermore, 
applicant may file an additional continuation application or request 
for continuation examination with a petition and showing. Under this 
final rule, applicant should have sufficient time to file a divisional 
application for claiming a non-elected invention. Therefore, the Office 
will most likely not grant a petition under Sec.  1.78(d)(1)(vi) to 
permit an applicant to file a divisional application directed to a non-
elected invention.
    Comment 80: One comment suggested a petition under Sec.  1.78(d)(1) 
should be granted when an applicant needs an additional continuing 
application to partition the claims in the prior-filed application, 
such that a terminal disclaimer applies only to some but not all claims 
in the prior-filed application. The comment alternatively suggested 
changing the regulations to allow the filing of a terminal disclaimer 
for selected claims.
    Response: This final rule permits applicant to file two 
continuation or continuation-in-part applications plus a request for 
continued examination in an application family, without justification. 
Therefore, applicant may use one of the two permitted continuation or 
continuation-in-part applications to partition the claims such that a 
terminal disclaimer applies to the prior-filed application but does not 
apply to the continuation application. Notably, applicant may avoid 
this situation by presenting all of the patentably indistinct claims in 
a single application. As discussed previously, multiple applications 
with patentably indistinct claims divert the Office's patent examining 
resources from the examination of new applications. Applicant should 
submit all patentably indistinct claims in a single application. See 
Sec. Sec.  1.75(b)(4) and 1.78(f). Under this final rule, applicant 
must identify such multiple applications with patentably indistinct 
claims to the Office and assist the Office in resolving double 
patenting issues early in the prosecution. In the situation in which an 
application contains at least one claim that is patentably indistinct 
from at least one claim in another application, the Office will treat 
the claims in both applications as being present in each of the 
applications for the purposes of determining whether each application 
exceeds the five independent claim and twenty-five total claim 
threshold under Sec.  1.75(b). See the discussion of Sec.  1.75(b)(4). 
Accordingly, the Office is not likely to grant a petition for the sole 
purpose of partitioning claims to avoid a terminal disclaimer.
    Additionally, a disclaimer of a terminal portion of the term of an 
individual claim, or individual claims, is not allowed by statute. 35 
U.S.C. 253 provides that ``any patentee or applicant may disclaim or 
dedicate to the public * * * any terminal part of the term, of the 
patent granted or to be granted.'' (Emphasis added.) Therefore, under 
35 U.S.C. 253, a terminal disclaimer must be of a terminal portion of 
the term of the entire patent and cannot be applied to selected claims 
as advocated in the comment.
    Comment 81: Several comments asserted that an applicant filing an 
additional continuation-in-part application would be able to argue 
successfully that the amendment or argument could not have been 
previously submitted because the subject matter was not present at the 
time of filing the initial application. Thus, the proposed rules would 
force these applicants to file a pro forma petition.
    Response: The mere fact that the subject matter was not present at 
the time of filing the prior-filed application would not be a 
sufficient showing under Sec.  1.78(d)(1)(vi). The Office will decide 
these petitions on a case-by-case basis based on the prosecution 
history of the prior-filed application as well as the records of the 
continuation-in-part application. The Office will consider the showing 
of why the new subject matter sought to be entered could not have been 
previously submitted in the prior-filed application. The Office will 
also consider the amendment including any new claims to determine 
whether the claims in the continuation-in-part application are directed 
to the new subject matter or mainly to the subject matter disclosed in 
the prior-filed application. For example, if the new subject matter is 
not being claimed in the continuation-in-part application, but merely 
being added to circumvent the rule, the Office will not grant the 
petition. Furthermore, 35 U.S.C. 120 requires that the prior-filed 
application disclose the subject matter of at least one claim of the 
later-filed application in the manner provided by 35 U.S.C. 112, ] 1, 
for the later-filed application to actually receive the benefit of the 
filing date of the prior-filed application. Thus, any claim in the 
continuation-in-part application that is directed to the subject matter 
not disclosed in the manner provided by 35 U.S.C. 112, ] 1, in the 
prior-filed application would be entitled only to the actual filing 
date of the continuation-in-part application (not the filing date of 
the prior-filed application), and subject to prior art based on the 
actual filing date of the continuation-in-part application. Applicant 
should not claim the benefit of the prior-filed application if all of 
the claims in the continuation-in-part application are directed to the 
new subject matter. The continuation-in-part application would not be 
entitled to the benefit of the filing date of the prior-filed 
application, and the term of any patent resulting from the 
continuation-in-part application will be measured under 35 U.S.C. 
154(a)(2) from the filing date of the prior-filed application. That is, 
applicant would not receive any benefit of the earlier application but 
would have a patent term that is measured from the filing date of the 
earlier application. If there are any claims in the continuation-in-
part application that are directed solely to subject matter disclosed 
in the prior-filed application, applicant must submit those claims in 
the prior-filed application rather than filing a continuation-in-part 
application unless applicant provides a showing as to why these claims 
could not have been previously submitted.
    Comment 82: Several comments requested that the Office permit an 
applicant to file an additional continuing application or request for 
continued examination when the applicant indicates why the new 
invention could not otherwise be protected using another type of 
application, such as a reissue application or a reexamination 
proceeding. These comments also requested that the Office permit an 
additional continuing application or an additional request for 
continued examination that contains claims broader than in the previous 
application to which priority is claimed and contain claims not subject 
to a double patenting rejection.
    Response: The Office will likely not grant such a petition. 
Applicant may file a reissue application under 35 U.S.C. 251 or a 
reexamination proceeding, if appropriate, to submit claims with 
different scope. A desire to avoid the requirements governing reissue

[[Page 46773]]

applications or reexamination proceedings would not be a sufficient 
showing under Sec.  1.78(d)(1)(vi) or 1.114(g).
    Comment 83: One comment sought clarification on whether the 
required showing under Sec. Sec.  1.78(d)(1) and 1.114 will preclude 
explanations that are permitted when filing a reissue application. A 
further comment stated the required showing under Sec. Sec.  1.78(d)(1) 
and 1.114 is greater than the showing required to file a reissue 
application.
    Response: This final rule permits applicant to file two 
continuation or continuation-in-part applications plus one request for 
continued examination in an application family, without any 
justification. Applicant may also file a third or subsequent 
continuation or continuation-in-part application or a second or 
subsequent request for continued examination with a petition and 
showing that the amendment, argument, or evidence sought to be entered 
could not have been submitted previously. As previously discussed, if 
an amendment, argument, or evidence could have been submitted during 
the prosecution of the initial application, two continuation or 
continuation-in-part applications or a request for continued 
examination, applicant must submit the amendment, argument or evidence 
in one of these filings, rather than in a third or subsequent 
continuing application or second or subsequent request for continued 
examination to ensure that applicant advances the prosecution to final 
action and does not impair the ability of the Office to examine new 
applications.
    Under 35 U.S.C. 251, applicant may file a reissue application to 
correct an error in the patent which was made without any deceptive 
intent, where, as a result of the error, the patent is deemed wholly or 
partly inoperative or invalid. See MPEP section 1402. The required 
showing under Sec. Sec.  1.78(d)(1)(vi) and 1.114(g) is different than 
the explanation required for filing a reissue application. The showing 
under Sec. Sec.  1.78(d)(1)(vi) and 1.114(g) does not require an error 
made without any deceptive intent and does not require as a result of 
the error, the patent to be deemed wholly or partly inoperative or 
invalid. If it is more appropriate for applicant to file a reissue 
application, applicant should file a reissue application under 35 
U.S.C. 251 rather than filing a continuing application.
    Comment 84: Several comments suggested that if the Office permits 
applicant to provide additional evidence of unexpected results with the 
filing of an additional continued examination filing, then the 
experimentation leading to the evidence must have been conducted 
diligently and commenced within six months of the filing of the initial 
application. Another comment further suggested evidence that an 
applicant had not previously learned or known that others had developed 
similar or parallel technology should not be considered as evidence 
that an amendment, argument or evidence could not have been submitted 
previously under Sec.  1.78(d)(1) or 1.114.
    Response: The Office will decide petitions under Sec.  
1.78(d)(1)(vi) or 1.114(g) on a case-by-case basis. The Office will 
focus on whether the evidence or data submitted with the petition to 
meet the showing under Sec.  1.78(d)(1)(vi) or 1.114(g) was presented 
in a timely manner and was diligently obtained. Any evidence or data 
that petitioner did not act diligently in obtaining in response to a 
rejection or requirement in an Office action will be considered 
unfavorably when deciding a petition under Sec.  1.78(d)(1)(vi) or 
1.114(g). For example, the Office will likely not grant a petition if 
the examiner made the rejection in the first Office action of the 
initial application and maintained it in the subsequent Office actions, 
but applicants responded only with arguments, instead of with evidence 
or an amendment, until after the final Office action. In contrast, the 
Office will likely grant a petition if, in a continuing application or 
request for continued examination, the data necessary to support a 
showing of unexpected results just became available to overcome a new 
rejection under 35 U.S.C. 103 made in the final Office action, and the 
data is the result of a lengthy experimentation that was diligently 
commenced and could not have been completed earlier. Applicant should 
exercise reasonable foresight to commence any appropriate 
experimentation early rather than wait until the examiner makes a 
rejection or finds applicant's arguments unpersuasive.
    Comment 85: Several comments sought clarification on whether an 
additional continued examination filing would be permitted under Sec.  
1.78(d)(1) or 1.114 for submitting an information disclosure statement 
or an amendment in view of an information disclosure statement in the 
following situations: (1) To submit a newly discovered reference, 
including a reference cited in a foreign counterpart application; (2) 
to submit a new reference that was not publicly available at the time 
the previous amendment was filed; (3) to submit an amendment to the 
claims that is necessitated by previously cited prior art or newly 
discovered prior art; and (4) to submit broadened claims after receipt 
of a foreign search or examination report citing new art. One comment 
argued that submissions of late discovered prior art should be 
permitted because the consideration of the prior art will improve 
patent quality and eliminate allegations of inequitable conduct in 
obtaining patent rights.
    Response: The Office will likely not grant such a petition for 
submitting an information disclosure statement (IDS) or an amendment 
necessitated by (or in view of) newly discovered prior art. The 
effectiveness and quality of the examination process as well as 
patentability determinations would improve if the most pertinent 
information were presented early in the examination process. An 
additional continued examination filing is not necessary for the 
consideration of newly discovered prior art or an amendment to the 
claims that is necessitated by the newly discovered prior art. See 
Changes To Information Disclosure Statement Requirements and Other 
Related Matters, 71 FR at 38812-16, 38820-22, 1309 Off. Gaz. Pat. 
Office at 27-31, 34-36 (proposed changes to Sec. Sec.  1.97 and 1.98 
permit applicant to submit prior art for consideration by the examiner, 
when applicant complies with specific requirements at various time 
periods, including after final action, notice of allowance and payment 
of the issue fee).
    The proposed IDS changes (if adopted) would permit applicant to 
submit an IDS after a first Office action on the merits, but before the 
mailing date of a notice of allowability or a notice of allowance under 
Sec.  1.311, if applicant files the IDS with either: (1) The 
certification under Sec.  1.97(e)(1) and a copy of the foreign search 
report, or (2) an explanation under proposed Sec.  1.98(a)(3)(iv) as to 
why each reference is being cited, and a non-cumulative description 
under proposed Sec.  1.98(a)(3)(v) as to how each reference is not 
cumulative of any other reference cited. Applicant would also be 
permitted to submit an IDS after allowance but before the payment of 
the issue fee, if applicant files the IDS with a patentability 
justification under proposed Sec.  1.98(a)(3)(vi), including any 
appropriate amendments to the claims.
    Applicant would also be permitted to submit an IDS after the 
payment of the issue fee if applicant files a petition to withdraw from 
issue pursuant to Sec.  1.313(c)(1), the patentability justification 
under proposed Sec.  1.98(a)(3)(vi)(B), and an amendment to the claims. 
Prior to the effective date of the final rule of the changes to IDS

[[Page 46774]]

requirements, applicant may submit an IDS after the close of 
prosecution with a petition under Sec.  1.183 if the IDS submission 
complies with the proposed rule requirements in Sec. Sec.  1.97 and 
1.98.
    Comment 86: Several comments sought clarification as to whether an 
additional continued examination filing would be permitted under 
Sec. Sec.  1.78(d)(1) and 1.114 in the following situations: (1) When 
the examiner found the earlier arguments and amendments by applicants 
to be unpersuasive; (2) when the examiner's interpretation of the 
claims is unusual and only recently understood by the applicant; (3) 
when the examiner changes his or her interpretation of claim language; 
and (4) when the practitioner discovers that the examiner is under a 
misunderstanding.
    Response: These circumstances alone more than likely would not be 
sufficient to establish a showing under Sec.  1.78(d)(1)(vi) or 
1.114(g). Applicant should request an interview with the examiner to 
resolve these types of issues during the prosecution of the initial 
application, two continuation or continuation-in-part applications and 
request for continued examination. In addition, applicant in each reply 
to an Office action must distinctly and specifically point out the 
supposed errors in the Office action and must reply to every ground of 
objection and rejection raised in the Office action. See Sec.  
1.111(b). The reply must also present detailed explanations of how each 
claim is patentable over any applied references. See Sec. Sec.  
1.111(b) and (c). If applicant disagrees with the examiner's decision 
to maintain a rejection on the basis that the applicant feels that the 
examiner is misinterpreting the claims, applicant should seek an appeal 
rather than file additional continuing applications or requests for 
continued examination.
    Comment 87: Several comments sought clarification on whether an 
additional continued examination filing would be permitted under 
Sec. Sec.  1.78(d)(1) and 1.114 when the examiner makes a new ground of 
rejection in a final Office action using a new prior art reference, a 
reference already of record but not previously applied, a new basis for 
the rejection (e.g., changing a rejection under 35 U.S.C. 102 to a 
rejection under 35 U.S.C. 103), or a different reasoning (e.g., the 
supporting arguments have changed or the rejection refers to a new 
portion of the applied art). Several comments stated that permitting a 
final rejection based on a new ground of rejection while not allowing 
further opportunity to amend through continued examination applications 
is unfair and presents an opportunity for abuse.
    Response: The Office will decide each petition for an additional 
continued examination filing on a case-by-case basis, focusing on 
whether the new ground of rejection in the final Office action could 
have been anticipated by the applicant. For example, the Office will 
likely grant a petition if the final rejection, after the two 
continuing applications and request for continued examination permitted 
under Sec. Sec.  1.78(d)(1) and 1.114(g) without a petition, contains a 
new ground of rejection that could not have been anticipated by 
applicant. However, the Office will likely not grant a petition under 
Sec.  1.78(d)(1)(vi) or 1.114(g) if the examiner only changed a 
rejection under 35 U.S.C. 102 to a rejection under 35 U.S.C. 103 (or 
maintained a rejection under 35 U.S.C. 103) with the addition of a new 
secondary reference in response to an amendment adding a new claim 
limitation because such a new rejection should have been anticipated by 
the applicant. Therefore, the mere fact that the examiner made a new 
ground of rejection in a final Office action probably would not 
constitute a sufficient showing.
    Comment 88: Several comments sought clarification on whether an 
additional continued examination filing would be permitted under 
Sec. Sec.  1.78(d)(1) and 1.114 in the following situations: (1) When 
the examiner indicates in an advisory action that an after-final 
amendment would require a new search; or (2) to submit evidence or an 
amendment to overcome a final rejection.
    Response: The Office will likely not grant a petition based on the 
mere showing that the examiner indicates in an advisory action that the 
entry of an after-final amendment would require a new search, or that 
the evidence or amendment sought to be entered will overcome a final 
rejection. Applicants are permitted to submit any desired amendment, 
argument, or evidence during the prosecution of the initial 
application, two continuation or continuation-in-part applications and 
one request for continued examination. Since numerous opportunities are 
given to submit any desired amendment, argument, or evidence, the mere 
fact that an amendment, argument, or evidence is refused entry because 
prosecution in the prior-filed application is closed will not, by 
itself, be a sufficient reason to warrant the grant of a petition under 
Sec.  1.78(d)(1)(vi) or 1.114(g). Rather, an applicant will be expected 
to demonstrate why the amendment, argument, or evidence sought to be 
entered could not have been submitted prior to the close of prosecution 
in the prior-filed application.
    Comment 89: Several comments sought clarification as to whether the 
Office will likely grant a petition for an additional continuing 
application if some of the claims in the prior application are rejected 
and other claims are allowed, and applicant wishes to appeal the 
rejected claims and obtain a patent on the allowed claims.
    Response: The Office is not likely to grant a petition under Sec.  
1.78(d)(1)(vi) in this situation in the absence of special 
circumstances. Section 1.78(d)(1)(i) permits an applicant whose initial 
application contains rejected claims and allowed claims to obtain a 
patent on the allowed claims, and continue prosecution of the rejected 
or other claims in a continuation or continuation-in-part application. 
The applicant is expected to use the two continuation or continuation-
in-part applications permitted without any petition or showing under 
Sec.  1.78(d)(1)(i) for this purpose. The applicant needs to pursue an 
appeal (or cancel the rejected claims) if the application still 
contains rejected claims after a second continuing application and 
request for continued examination.
    Comment 90: Several comments suggested that applicant should be 
permitted to file an additional continuing application under Sec.  
1.78(d)(1) or request for continued examination under Sec.  1.114 for 
changing the scope of the claims in the following situations: (1) 
Pursue claims that have the same or narrower scope as the claims in an 
allowed application; (2) claim a species or subgenus that falls within 
a generic claim that has been allowed or issued in one of the prior-
filed applications; (3) pursue the rejected or broader claims when 
other claims are allowable; (4) file broader claims, when applicant 
recently discovered a limitation in an allowed claim that was unduly 
limiting; (5) pursue broader claims, or claim aspects of the invention 
that are disclosed, but not claimed, in the prior-filed application 
(contains claims to an unclaimed invention disclosed in the prior-filed 
application); (6) pursue narrower claims; (7) claim inventions of a 
different scope when the scope of new claims finds specific support in 
the application as filed; (8) pursue new claims when the scope of new 
claims was unintentionally omitted from the initial application; or (9) 
protect a different aspect of the invention revealed by research and 
development

[[Page 46775]]

subsequent to an initial application filing.
    Response: If a claim can be submitted during the prosecution of the 
initial application, two continuation or continuation-in-part 
applications and one request for continued examination, applicant must 
present such a claim early in these filings rather than wait to submit 
it later in an additional continuing application or request for 
continued examination. The situations described in the comments do not 
present any reason why claims directed to claims with the same, 
narrower, or broader scope could not have been submitted earlier. 
Applicants may file a reissue application under 35 U.S.C. 251, if 
appropriate, to submit claims with a different scope.
    Comment 91: Several comments sought clarification on whether an 
additional continued examination filing would be permitted under 
Sec. Sec.  1.78(d)(1) and 1.114 for the following situations: (1) When 
a product recently becomes commercially viable; (2) when a competing 
product is newly discovered; (3) when new information is discovered 
that could not have been provided in the prior application; (4) when 
applicant discovered new inherent properties that he or she now wishes 
to claim; (5) when applicant now has the financial resources to file 
previously unclaimed inventions; (6) when clinical trials indicate the 
previously unclaimed subject matter may be useful; or (7) when the 
court determined that the format of a patented claim is improper and 
applicant wishes to file a continuing application to seek the proper 
protection.
    Response: The Office likely will not grant such a petition in these 
situations. Applicant is permitted to file two continuation or 
continuation-in-part applications and a request for continued 
examination without a petition and showing. Applicant should have 
sufficient time to submit any desired claims. Applicant should also 
know what the applicant regards as his or her invention and claim his 
or her invention during the prosecution of these applications, 
regardless of whether applicants have recently discovered a 
commercially viable product, financial resources, useful subject 
matter, a competing product, or similar or parallel technology on the 
market. Applicants may file a reissue application under 35 U.S.C. 251, 
if appropriate, to correct or amend any patented claims. The Office 
would not likely grant a petition to permit an applicant to end-run the 
two-year filing period requirement of 35 U.S.C. 251, ] 4.
    Comment 92: Several comments suggested allowing an applicant to 
file an additional continuing application or request for continued 
examination to claim inventions related to drugs undergoing the FDA 
approval process. In particular, one comment suggested two ways of 
satisfying the required showing under Sec. Sec.  1.78(d)(1) and 1.114: 
(1) An applicant provides an affidavit or other statement to the Office 
confirming that the applicant is presently engaged in obtaining 
information needed for submitting an Investigational New Drug (IND) 
application for that drug; or (2) an applicant provides evidence to the 
Office that the applicant has already submitted an IND or a Biologics 
License Application (BLA) (or an amended IND application or amended 
BLA) for the particular drug.
    Response: Such evidence of ongoing FDA review for a drug allegedly 
claimed in an application would not by itself be considered a 
sufficient showing under Sec.  1.78(d)(1)(vi) or 1.114(g). Applicant 
should know what the applicant regards as his or her invention upon 
filing an application and should claim the invention prior to, or 
regardless of, any FDA approval. There is no reason why an applicant 
must have FDA approval prior to deciding for which aspect(s) of the 
invention or which invention(s) to seek patent protection. See In re 
Brana, 51 F.3d 1560, 1568, 34 U.S.P.Q.2d 1436, 1442 (Fed. Cir. 1995) 
(``FDA approval * * * is not a prerequisite for finding a compound 
useful within the meaning of the patent laws.''). The changes adopted 
in this final rule permit an applicant to file two continuation or 
continuation-in-part applications and one request for continued 
examination in the application family, without any justification. In 
addition, applicant may file a divisional application directed to each 
non-elected invention that has not been examined if the prior-filed 
application was subject to a restriction requirement and the claims to 
the non-elected invention are cancelled upon filing of the divisional 
application. Applicant may also file two continuation applications of 
the divisional application and a request for continued examination in 
the divisional application family, without justification. And, 
applicant may file a third of subsequent continuation application or a 
second request for continued examination with a petition and showing. 
If applicant is not prepared to particularly point out and distinctly 
claim what the applicant regards as his or her invention during the 
prosecution of the initial application, its two continuing 
applications, and a request for continued examination in each 
application family, applicant should consider using the deferral of 
examination process. See Sec.  1.103(d).
    The Office recognizes that, in certain unpredictable arts 
(including, for example, biotechnology and certain pharmaceuticals), 
there may be a need for research or testing to obtain additional 
evidence or data to obviate a rejection for lack of utility under 35 
U.S.C. 101 (and consequently for lack of enablement under 35 U.S.C. 
112, ] 1). The case law, however, does not shift the burden to the 
applicant to provide rebuttal evidence or data concerning the 
invention's utility until the examiner ``provides evidence showing that 
one of ordinary skill in the art would reasonably doubt the asserted 
utility.'' Brana, 51 F.3d at 1566, 34 U.S.P.Q.2d at 1441 (citing In re 
Bundy, 642 F.2d 430, 433, 209 U.S.P.Q. 48, 51 (CCPA 1981)). Even in 
situations in which a requirement for such additional evidence is 
appropriate, the evidence or data that would warrant an applicant's 
decision to initiate the FDA regulatory process should be sufficient to 
establish utility for purposes of compliance with 35 U.S.C. 101 and 
112, ] 1. See MPEP Sec.  2107.03 (as a general rule, if an applicant 
has initiated human clinical trials for a therapeutic product or 
process, Office personnel should presume that the applicant has 
established that the subject matter of that trial is reasonably 
predictive of having the asserted therapeutic utility). With respect to 
situations in which it is questionable as to whether there is 
sufficient enablement for the invention as claimed, evidence submitted 
to the FDA to obtain approval for clinical trials may be submitted. 
However, considerations made by the FDA for approving clinical trials 
are different from those made by the Office in determining whether a 
claim is sufficiently enabled. See MPEP Sec.  2164.05 (citing Scott v. 
Finney, 34 F.3d 1058, 1063, 32 U.S.P.Q.2d 1115, 1120 (Fed. Cir. 1994)). 
Thus, situations in which it is necessary for an applicant to submit 
data to the Office to demonstrate patentability using data obtained 
from research or testing carried out as part of the FDA regulatory 
process should be rare.
    Nevertheless, in the situation in which there is a rejection such 
as lack of utility under 35 U.S.C. 101 (and/or consequently for lack of 
enablement under 35 U.S.C. 112, ] 1) in an application claiming subject 
matter in such an unpredictable art, the Office will likely grant a 
petition under Sec.  1.78(d)(1)(vi) or 1.114(f) if, in a continuing 
application or request for

[[Page 46776]]

continued examination, the evidence or data to demonstrate utility or 
enablement just became available or could not have been otherwise 
earlier presented, and the evidence or data resulted from research or 
testing that was commenced with reasonable diligence. However, this 
presupposes that the applicant has taken reasonable steps to resolve 
the issue during the prosecution of the initial (or divisional) 
application, its two continuing applications, and a request for 
continued examination in each application family. In particular, the 
Office will consider, inter alia, whether the applicant: (1) Sought 
review of the rejection via an appeal that proceeded to at least the 
appeal conference stage and resulted in an examiner's answer (rather 
than simply filing continuing applications or a request for continued 
examination without the evidence or data to again argue patentability 
before the examiner); (2) initiated the research or testing promptly 
(rather than waiting for a decision to initiate the FDA regulatory 
review process); and (3) sought suspension of action (Sec.  1.103(a) or 
(c)) or deferral of examination if applicable (Sec.  1.103(d)) in the 
continuing applications or the request for continued examination and 
alerted the Office of the research or testing.
    Comment 93: Several comments sought clarification whether the 
Office would grant a petition for an additional continuing application 
or request for continued examination to correct the inventorship of the 
application due to information discovered after prosecution of the 
application has closed.
    Response: The Office will likely not grant such a petition. 
Applicant should make the correction early in the examination process. 
Furthermore, the Office has recently proposed changes to Sec.  1.312 to 
provide that the Office may permit a correction of the inventorship 
filed in compliance with Sec.  1.48 after the mailing of a notice of 
allowance if certain requirements are met, such as if the correction is 
filed before or with the payment of the issue fee or if the correction 
is filed with the processing fee set forth in Sec.  1.17(i) and in 
sufficient time to permit the patent to be printed with the correction. 
See Changes To Information Disclosure Statement Requirements and Other 
Related Matters, 71 FR at 38817-8, 38823, 1309 Off. Gaz. Pat. Office at 
32, 37. Finally, after the patent has issued, applicant may correct the 
inventorship by filing a reissue application under 35 U.S.C. 251 or 
pursuant to 35 U.S.C. 256.
    Comment 94: One comment discussed that the limitations on 
continuing applications may create due process issues because there may 
be different treatment of joint inventors of an application. The 
comment provided an example of an application filed naming joint 
inventors, e.g., Inventors C and D, and ensuing problems caused by the 
proposed rules as follows: Inventor C files a continuation application 
to prosecute his or her invention. Inventor D may be deprived of filing 
a continuation application on his invention because the filing by 
Inventor D would be a second or subsequent continuing application that 
would require a petition under Sec.  1.78(d)(1).
    Response: This final rule permits applicants to file two 
continuation or continuation-in-part applications plus one request for 
continued examination without justification. Applicants may file a 
third or subsequent continuation or continuation-in-part application or 
a second or subsequent request for continued examination with a 
petition and showing. Under Sec.  1.78(d)(1)(i), Inventor C is 
permitted to file a continuation application (the first continuation 
application) to prosecute his or her invention, and Inventor D is 
permitted to file a continuation application (the second continuation 
application) to prosecute his or her invention.
    Comment 95: Several comments sought clarification whether the 
Office will grant a petition for an additional continuing application 
or request for continued examination for the purpose of provoking an 
interference.
    Response: The Office will likely not grant a petition with a 
showing that the additional continuation or continuation-in-part 
application or request for continued examination is solely for the 
purpose of provoking an interference. In most situations, applicants 
should have sufficient opportunity to provoke an interference and copy 
claims in a timely manner in compliance with 35 U.S.C. 135(b)(2) in the 
initial application, two continuation or continuation-in-part 
applications, and one request for continued examination, all of which 
are available without any justification. In any event, the Office is 
likely to require that a request for a statutory invention registration 
under Sec.  1.293 be submitted as a condition of granting any petition 
under Sec.  1.78(d)(1)(vi) in the situation where a third or subsequent 
continuation or continuation-in-part application or second or 
subsequent request for continued examination is for the purpose of 
provoking an interference. The Office, however, would likely grant a 
petition under Sec.  1.78(d)(1)(vi) (without requiring a request for a 
statutory invention registration under Sec.  1.293) in a limited 
situation where an interference is declared in a second continuation or 
continuation-in-part application that contains both claims 
corresponding to the count and claims not corresponding to the count, 
and the BPAI suggests that the claims not corresponding to the count be 
canceled from the application subject to the interference and pursued 
in a separate application.
    Comment 96: Several comments sought clarification as to whether the 
Office will grant a petition for an additional continuing application 
or request for continued examination when the Office changes the 
examiner assigned to the application either on its own initiative or in 
response to the applicant's request.
    Response: The Office will not grant such a petition. The mere fact 
that the Office changes the examiner assigned to the application would 
not be a sufficient showing under Sec.  1.78(d)(1)(vi) or 1.114(g).
    Comment 97: Several comments sought clarification as to whether the 
Office will grant a petition for an additional continuing application 
or request for continued examination when applicant changes the 
practitioner of record, when applicant states that the change of 
practitioner was made in good faith and certifies that the applicant 
was dissatisfied with the prior practitioner's claim drafting, or when 
the delay in filing claims was due to practitioner's error or inaction 
and was not the fault of the applicant. One comment expressed concern 
that if changing the practitioner of record is an acceptable reason, it 
will promote attorney swapping.
    Response: The Office will not grant such a petition for these 
circumstances. A change of practitioner, or errors or delays caused by 
the practitioner, would not be considered sufficient showings. An 
applicant is bound by the consequences of the acts or omissions of the 
applicant's duly authorized and voluntarily chosen legal 
representative. See Link v. Wabash R. Co., 370 U.S. 626, 633-34 (1962).
    Comment 98: One comment suggested that an applicant should be 
permitted to file an additional continuation or continuation-in-part 
application when the practitioner does not present the claims in the 
prior application because of excusable neglect.
    Response: Rule 60(b) of the Federal Rules of Civil Procedure (Rule 
60(b)) does provide ``excusable neglect'' as a basis (among others) for 
relieving a party of a judgment or order. See Fed. R. Civ. P. 60(b)(1). 
Rule 60(b), however, further provides that a motion based

[[Page 46777]]

upon ``excusable neglect'' must be ``made within a reasonable time,'' 
and ``not more than one year after the judgment, order, or proceeding 
was entered or taken.'' See Fed. R. Civ. P. 60(b). Sections 1.78(d)(1) 
and 1.114 as adopted in this final rule permit an applicant to file an 
initial application, two continuation or continuation-in-part 
applications, and a request for continued examination in any one of 
these three applications without justification. Given the numerous 
opportunities provided in Sec. Sec.  1.78(d)(1) and 1.114 to prosecute 
an application for patent, the ``mistake, inadvertence, surprise, or 
excusable neglect'' standard set forth in Rule 60(b)(1) is not an 
appropriate basis for seeking yet another opportunity to prosecute the 
application. Therefore, the Office is not likely to grant a petition 
under Sec.  1.78(d)(1)(vi) or 1.114(g) solely on the basis of 
``excusable neglect.''
    Rule 60(b)(6), however, does provide for relief on the ``catchall'' 
basis of ``any other reason justifying relief from the operation of the 
judgment.'' See Fed. R. Civ. P. 60(b)(6). While this language appears 
to be open-ended, this provision is typically limited to exceptional or 
extraordinary circumstances suggesting that a party was faultless in 
the delay. See Marquip, Inc. v. Fosber Am., Inc., 198 F.3d 1363, 1370, 
53 U.S.P.Q.2d 1015, 1020 (Fed. Cir. 1999) (citing Pioneer Inv. Serv. 
Co. v. Brunswick Assocs. Ltd. P'ship, 507 U.S. 380, 393 (1993)). The 
patent rules of practice (Sec.  1.183) provide that ``in an 
extraordinary situation'' in which ``justice requires,'' the Office may 
waive or suspend any requirement of the regulations in 37 CFR part 1, 
which is not a requirement of statute. The Office does not anticipate 
granting petitions under Sec.  1.78(d)(1)(vi) or 1.114(g) on a basis 
other than a showing that the amendment, argument or evidence sought to 
be entered could not have been previously submitted. However, in the 
rare exceptional or extraordinary situation in which an applicant was 
faultless in the delay, and the situation does not meet the standard 
that the amendment, argument or evidence sought to be entered could not 
have been previously submitted, the Office may grant relief pursuant to 
Sec.  1.183.
    Comment 99: Several comments sought clarification as to whether the 
Office will likely grant a petition for an additional continuing 
application or request for continued examination if the prior-filed 
application was abandoned in favor of a continuing application that was 
filed using the Office electronic filing system or if the request for 
continued examination was filed using the Office electronic filing 
system.
    Response: The Office will likely not grant such a petition. The 
mere fact that a continuing application or request for continued 
examination is electronically filed via the Office electronic filing 
system would not be a sufficient showing as to why the amendment, 
argument or evidence sought to be entered could not have been 
previously submitted.
    Comment 100: A few comments sought clarification as to whether the 
Office will likely grant a petition for an additional continuing 
application or request for continued examination if the applicant 
becomes disabled for a lengthy time during pendency of application.
    Response: The Office will likely not grant such a petition on the 
mere showing that the applicant becomes disabled for a lengthy time 
during pendency of application. The changes being adopted in this final 
rule permit applicants to file two continuation or continuation-in-part 
applications and a request for continued examination, without a 
petition and showing. Applicant may also file a third or subsequent 
continuation or continuation-in-part application or a second or 
subsequent request for continued examination with a petition and 
showing. Furthermore, applicant may file a petition for suspension of 
action under Sec.  1.103(a) or a request for deferral of examination 
under Sec.  1.103(d), when necessary.
    Comment 101: Several comments suggested an applicant should be 
permitted to file an additional continuation or continuation-in-part 
application or a request for continued examination for patent term 
extension reasons.
    Response: No patent term extension benefits under 35 U.S.C. 154 and 
156 will accrue to applicant by filing a third or subsequent continuing 
application or a second or subsequent request for continued 
examination. Therefore, a desire to obtain a patent term extension 
would not be a sufficient reason to permit a third or subsequent 
continuing application or a second or subsequent request for continued 
examination. In fact, the filing of a continuing application or request 
for continued examination may result in the loss of a patent term 
adjustment under 35 U.S.C. 154(b).
    Comment 102: A number of comments expressed concern regarding an 
example provided by the Office that would meet the showing under 
Sec. Sec.  1.78(d)(1) and 1.114 to permit the filing of an additional 
continuing application or request for continued examination. This 
example permits the applicant to file an additional continuing 
application or request for continued examination when the applicant can 
show that collection of the data necessary to demonstrate unexpected 
results was started after the applicant received the rejection for the 
first time, and was completed only shortly before filing the petition 
for an additional filing. A number of comments stated that granting a 
petition should only depend on when the information becomes available 
and not when the tests begin. One other comment stated that experiments 
are typically ongoing from the date of invention and that it would be 
inappropriate for the Office to require experimentation to overcome an 
obviousness rejection to commence only after the rejection has been 
made for the first time. One comment suggested removing the language, 
``could not have been anticipated by applicant,'' from the example 
provided by the Office of an adequate showing under Sec.  1.78(d)(1) or 
1.114. The comment expressed concern that the Office's example is vague 
and subjective, and that removal of the language, ``could not have been 
anticipated by applicant,'' would make the standard less arbitrary.
    Response: The example is merely one illustration of when a petition 
under Sec.  1.78(d)(1)(vi) or 1.114(g) will likely be granted. Other 
appropriate showings could result in a petition under Sec.  
1.78(d)(1)(vi) or 1.114(g) being granted. As discussed previously, the 
Office will focus on whether the evidence or data submitted was 
obtained and presented in a reasonably diligent manner.
    Comment 103: One comment expressed concern regarding the 
requirement under Sec.  1.78(d)(1) that an applicant must submit a 
petition within four months from the actual filing date of the later-
filed continuing application, stating that applicant may need more time 
to complete the experimentation or to prepare the submission in 
response to a rejection or a requirement for information. This comment 
suggested that the Office should accept an interim statement from the 
applicant when more time is needed, such as a statement that the 
experimentation is progressing, but is not completed.
    Response: Applicant should prepare a reply diligently upon 
receiving the final Office action in the prior application, which 
provides a six-month statutory period for reply. There is no reason why 
an applicant should delay preparing a petition under Sec.  
1.78(d)(1)(vi) until a third or subsequent continuing application has 
been filed. Applicants

[[Page 46778]]

should not rely solely upon the four-month time period under Sec.  
1.78(d)(1)(vi) to prepare and file a petition under Sec.  
1.78(d)(1)(vi) for a third or subsequent continuing application. 
Therefore, the four-month time period from the actual filing date of a 
third or subsequent continuing application is a reasonable deadline to 
file a petition under Sec.  1.78(d)(1)(vi).
    Comment 104: A number of comments requested clarification regarding 
who will decide the petitions under Sec. Sec.  1.78(d)(1) and 1.114. 
Several comments argued that examiners should not decide the petitions 
under Sec. Sec.  1.78(d)(1) and 1.114. Furthermore, a number of 
comments argued that there is a danger that the standard would be 
applied differently in different Technology Centers. Several comments 
suggested that the Office of Petitions should decide the petitions to 
encourage consistency, ensure uniform interpretation of the rules, and 
reduce the impact on examining resources. Yet another comment suggested 
that the BPAI should review the showing required under Sec. Sec.  
1.78(d)(1) and 1.114. The comments further argued that there is a 
potential for both disparate treatment and inconsistent application of 
Sec. Sec.  1.78(d)(1) and 1.114 depending on who decides the petitions 
and that the potential of either would violate the concept of equal 
protection under the law.
    Several comments requested clarification regarding the procedures 
for appealing the denial of a petition under Sec.  1.78(d)(1)(vi) or 
1.114(g). Specifically, the comments questioned whether a denial of a 
petition should be appealed to the BPAI or petitioned to the Director. 
The comment further requested that the Office publish the decisions to 
encourage consistency and understanding of the standard. One comment 
sought clarification on the remedies available to an applicant if the 
Office denies a petition for an additional continuing application or 
request for continued examination when the examiner introduced new 
prior art in a final Office action. One comment questioned whether 
petitions under Sec. Sec.  1.78(d)(1) and 1.114 could be decided 
objectively due to the Office's desire to dramatically curtail 
continuing applications and requests for continued examination.
    Response: The Office is making every effort to become more 
efficient, to apply the rules and statutes uniformly, and to allocate 
Office resources properly. The authority to decide petitions under 
Sec. Sec.  1.78(d)(1)(vi) and 1.114(g) has been delegated to the Deputy 
Commissioner for Patent Examination Policy (who may further delegate 
this authority to officials under the Deputy Commissioner for Patent 
Examination Policy). A decision on a petition under Sec.  
1.78(d)(1)(vi) or 1.114(g) is not appealable to the BPAI. The denial of 
a petition under Sec.  1.78(d)(1)(vi) or 1.114(g) may be viewed as a 
final agency action for the purposes of judicial review under 5 U.S.C. 
704. See MPEP Sec.  1002.02. Final decisions of the Office of the 
Commissioner for Patents are accessible in the Freedom of Information 
Act (FOIA) section of the Office's Internet Web site at (http://www.uspto.gov/web/offices/com/sol/foia/comm/comm.htm).
    The Deputy Commissioner for Patent Examination Policy and officials 
under the Deputy Commissioner for Patent Examination Policy will decide 
petitions under Sec. Sec.  1.78(d)(1)(vi) and 1.114(g) on their merits 
and the facts in the record and apply the standard in a consistent 
manner. The officials who will decide petitions under Sec. Sec.  
1.78(d)(1)(vi) and 1.114(g) are professionals who perform their duties 
within the framework of the law, rules, and examination practice. The 
Office only desires to curtail continuing applications and requests for 
continued examination in situations in which the continued examination 
filing is for the purpose of presenting an amendment, argument or 
evidence that could have been, but was not, submitted earlier. The 
Office recognizes the need for continued examination filings for 
presenting an amendment, argument or evidence that truly could not have 
been submitted earlier.
    Comment 105: A number of comments requested that the Office set a 
time limit for rendering decisions on petitions under Sec. Sec.  
1.78(d)(1) and 1.114. The comments suggested that the Office should set 
up an adequately staffed office to decide the petitions promptly, and 
in any event, before the close of prosecution of the parent application 
so that applicants are advised of their prosecution options. The 
comments further suggested that the Office should grant the petition if 
it is not decided prior to the close of prosecution.
    Response: The Office is continuing to ensure prompt and consistent 
decisions on petitions. It is the general policy of the Office that 
petitions are decided in the order that they are filed in the Office. 
Moreover, the Office will likely deny any petition under Sec.  
1.78(d)(1)(vi) or 1.114(g) filed before the close of prosecution 
because applicant may still submit the amendment, argument, or evidence 
in the application if the prosecution is open. Further, in such 
situation, it is unlikely that applicants will be able to show that the 
amendment, argument, or evidence sought to be entered could not have 
been previously submitted.
    Comment 106: One comment sought clarification regarding the status 
of an application during consideration of the petition. Specifically, 
the comment questioned whether an applicant who had filed a petition 
under Sec.  1.78(d)(1) or 1.114 would be permitted to file a notice of 
appeal under Sec.  41.31(a) within the time period provided in Sec.  
1.134 to avoid abandonment of the application if the petition is 
dismissed. The comment also inquired whether the notice of appeal fee 
would be refunded if the petition were granted. Several other comments 
suggested that the filing of a petition under Sec.  1.78(d)(1) or 1.114 
should serve as a notice of appeal if the petition is dismissed. In the 
alternative, several comments suggested that the Office should allow 
applicants additional time to file a notice of appeal after the 
dismissal of a petition.
    Response: The Office will make every effort to decide the petitions 
in a timely manner. The rules have not changed the time period for 
filing a notice of appeal or an appeal brief. Pursuant to Sec.  
41.31(a)(1), an applicant must file a notice of appeal accompanied by 
the fee set forth in Sec.  41.20(b)(1) within the time period for reply 
set forth in the Office action. The notice of appeal fee is set by 
statute and is non-refundable. If the Office grants the petition prior 
to a decision on the merits by the BPAI, the fees paid for the notice 
of appeal and the appeal brief can be applied to a later appeal on the 
same application. See MPEP Sec.  1207.04. Additionally, the filing of a 
petition will not serve as a notice of appeal, and the Office will not 
allow more time to file a notice of appeal. The filing of a petition, 
moreover, does not toll the period for reply to any outstanding Office 
action. An applicant should not use the continued examination practice 
as a substitute for an appeal. Rather, an applicant should appeal the 
decision if warranted.
    Comment 107: One comment sought clarification of the status of the 
application if, after filing a notice of appeal under Sec.  41.31(a), 
an applicant later files a petition under Sec.  1.114 with a request 
for continued examination (with a submission and the appropriate fees), 
which is dismissed. The comment questioned whether the application 
would be abandoned given that the filing of a request for continued 
examination would be treated as a request to withdraw the appeal.
    Response: In the situation described in the comment, the 
application would be abandoned if the application has no

[[Page 46779]]

allowed claims because the request for continued examination would be 
treated as a request to withdraw the appeal. See MPEP Sec.  1215.01.
    In the situation where applicant already filed a request for 
continued examination in the application family, a better alternative 
is for applicant to file the request for continued examination with a 
petition under Sec.  1.114(g), and then if the petition is not decided 
prior to the expiration of the statutory period for reply to the final 
Office action, applicant may file a notice of appeal within the period 
for reply (and petition for any extension of this period under Sec.  
1.136(a) or (b), if necessary) to avoid abandonment of the application. 
If the Office subsequently dismisses the petition, the request for 
continued examination will be treated as an improper request for 
continued examination. However, the request for continued examination 
will not be treated as a request to withdraw the appeal because the 
request for continued examination was filed before the notice of appeal 
(i.e., the application was not on appeal at the time of filing the 
request for continued examination).

E. Treatment of Multiple Applications

    Comment 108: A number of comments suggested the four-month time 
period provided in Sec.  1.78(f)(1) for identifying to the Office 
applications that meet the criteria set forth in Sec.  1.78(f)(1) is 
unreasonably short and is impractical in view of the time often 
required by the Office to assign application numbers and communicate 
these numbers to the applicants. One comment suggested the time period 
provided in Sec.  1.78(f)(1) for identifying to the Office applications 
that meet the criteria set forth in Sec.  1.78(f)(1) does not permit an 
applicant to timely identify an international application designating 
the United States of America that entered the national stage thirty 
months after the filing date of a nonprovisional application filed 
under 35 U.S.C. 111(a) when these two applications meet the criteria 
set forth in Sec.  1.78(f)(1).
    Response: The Office notes the concerns expressed in the public 
comments concerning the proposed changes to Sec.  1.78(f)(1). The 
Office has modified this provision relative to the proposed changes 
such that Sec.  1.78(f)(1) as adopted in this final rule provides 
applicant four months from the actual filing date of a nonprovisional 
application filed under 35 U.S.C. 111(a), four months from the date on 
which the national stage commenced under 35 U.S.C. 371(b) or (f) in a 
nonprovisional application which entered the national stage from an 
international application after compliance with 35 U.S.C. 371, or two 
months from the mailing date of the initial filing receipt in the other 
nonprovisional application, to identify other nonprovisional 
applications in compliance with Sec.  1.78(f)(1).
    Comment 109: A number of comments requested identification of any 
consequences for failing to identify one or more applications that meet 
the criteria set forth in Sec.  1.78(f)(1), or for failing to identify 
such applications within the time period set forth in Sec.  1.78(f)(1).
    Response: If applicant inadvertently fails to identify the other 
nonprovisional applications in compliance with Sec.  1.78(f)(1)(i) 
within the time period provided in Sec.  1.78(f)(1)(ii), applicant 
should submit the identification to the Office as soon as practical. If 
the submission necessitates a new rejection based upon double patenting 
(including an obviousness-type double patenting rejection) in a second 
or subsequent Office action on the merits, the examiner may make such 
an action final (assuming that the conditions for making a second or 
subsequent action final are otherwise met). The Office may also refer 
any registered practitioner who repeatedly fails to comply with the 
rule requirements to the Office of Enrollment and Discipline for 
appropriate action. Applicants and practitioners are strongly 
encouraged to revise their practices to ensure timely submissions of 
the required identification. Applicants and registered practitioners 
are reminded of their duties under Sec.  10.18 and other professional 
responsibility rules, and the consequences of any violations (e.g., 
Sec. Sec.  10.18(c), 10.18(d) and 10.23).
    Comment 110: A number of comments requested clarification of Sec.  
1.78(f)(1) and how it interacts with Sec.  1.56, including the 
preexisting duty of an applicant to disclose similar information to the 
Office under Sec.  1.56. Several comments stated that Sec.  1.78(f)(1) 
imposes burdens on the applicants that provide a new basis for 
inequitable conduct allegations.
    Response: Section 1.78(f)(1) provides that an applicant must 
identify other pending applications or patents that are commonly owned, 
have a common inventor, and have a claimed filing or priority date 
within two months of the claimed filing or priority date of the 
application. This requirement does not supplant an applicant's duty to 
bring other applications that are ``material to patentability'' of an 
application (e.g., applications containing patentably indistinct 
claims) to the attention of the examiner. Section 1.78(f)(1) does not 
provide a new basis for allegations of inequitable conduct when Sec.  
1.78(f)(1) is considered in light of the duties concurrently imposed on 
applicants and practitioners by Sec.  1.56 and the ethics rules in 37 
CFR Part 10, such as Sec.  10.18. See also Dayco, 329 F.3d at 1365-69, 
66 U.S.P.Q.2d at 1806-08 (individuals covered by Sec.  1.56 cannot 
assume that the examiner of a particular application is necessarily 
aware of other applications which are ``material to patentability'' of 
the application under examination, but must instead bring such other 
applications to the attention of the examiner).
    Comment 111: Several comments requested clarification regarding the 
applications that must be identified pursuant to Sec.  1.78(f)(1) when 
common inventor(s) and common ownership exist.
    Response: Applicant must identify those pending nonprovisional 
applications that are filed within two months of each other taking into 
account any filing date for which benefit is sought, that name at least 
one common inventor, and that are owned by the same person or subject 
to an obligation of assignment to the same person. For example, the 
applicant for application A is required to identify application B and 
the applicant for application B is required to identify application A 
in the following situation: The actual filing date of application A is 
August 8, 2006. Application A claims priority of a foreign application 
filed on August 10, 2005. The actual filing date of application B is 
April 11, 2006. Application B claims the benefit of a prior-filed 
nonprovisional application filed on October 4, 2005, and claims the 
benefit of a prior-filed provisional application filed on January 4, 
2005. Application A and application B have at least one common inventor 
and common ownership. Each applicant must identify the other 
application because application A has a filing date (August 10, 2005, 
the foreign priority date) within two months of a filing date of 
application B (October 4, 2005, the filing date of the nonprovisional 
application whose benefit is claimed by application B). ``Filing date'' 
includes the actual filing date, foreign priority date, and the filing 
date of a provisional, nonprovisional, or international application 
whose benefit is sought under title 35, United States Code.
    Comment 112: A number of comments objected that Sec. Sec.  
1.78(f)(1) and (2) require applicants to identify and resolve a 
possible double patenting issue prior to a rejection being issued by 
the examiner. One comment suggested that the rebuttable presumption in 
Sec.  1.78(f)(2) was akin to saying that if an

[[Page 46780]]

applicant submits prior art, there is a presumption of obviousness. One 
comment suggested that Sec.  1.78(f)(2) was unnecessary because Sec.  
1.78(f)(1) provides the Office with sufficient information to require a 
terminal disclaimer or require the cancellation of claims. One comment 
stated that many applicants will attempt to circumvent Sec.  1.78(f)(2) 
by filing multiple applications that meet the criteria set forth in 
Sec.  1.78(f)(2), but that include both patentably distinct claims and 
patentably indistinct claims.
    Response: The rebuttable presumption set forth in Sec.  1.78(f)(2) 
is a procedural tool requiring the applicant to help focus and 
consolidate the examination process and thus is not akin to a 
presumption of obviousness. The examination is more efficient when 
double patenting issues are identified and resolved early in the 
process. Where an applicant chooses to file multiple applications that 
are substantially the same, it will be the applicant's responsibility 
to assist the Office in resolving potential double patenting situations 
rather than taking no action until faced with a double patenting 
rejection. Although the ultimate determination of double patenting 
rests with the Office, applicants are in a far better position than the 
Office to identify applications that may raise double patenting 
concerns.
    Section 1.78(f)(2) requires applicant to resolve the double 
patenting issues early in the prosecution by either: (1) Filing a 
terminal disclaimer and an explanation as to why the multiple 
applications containing patentably indistinct claims are necessary; or 
(2) explaining how the application contains only claims that are 
patentably distinct from the claims of other related applications. 
Therefore, with the benefit of Sec.  1.78(f)(2), double patenting 
issues could be resolved more expeditiously before the first Office 
action on the merits, thus saving the examiner time by eliminating the 
need to search for related applications, analyze the potentially 
conflicting claims, and make the rejection. Merely identifying the 
other applications under Sec.  1.78(f)(1) would not result in these 
benefits.
    If the criteria set forth in Sec.  1.78(f)(2) are met, the 
rebuttable presumption would apply regardless of whether a few of the 
claims are patentably distinct from the claims in the other related 
applications because Sec.  1.78(f)(2) provides that ``a rebuttable 
presumption shall exist that a nonprovisional application contains at 
least one claim that is not patentably distinct * * * .'' To rebut this 
presumption, applicant must explain how the application contains only 
claims that are patentably distinct. Merely explaining that some of the 
claims are patentably distinct would not be sufficient to rebut this 
presumption.
    Comment 113: One comment objected that Sec.  1.78(f)(2) would 
impose an undue burden on inventors because it creates a presumption 
that commonly owned patent applications which share a common disclosure 
and at least one inventor, are patentably indistinct. The comment 
further asserted that the presumption is not in the interest of 
American competitiveness as American companies often file numerous 
patent applications with claims directed to different features of the 
same new product. One comment suggested that Sec.  1.78(f)(1) places an 
excessive burden on applicants to anticipate all the unique claims that 
could be filed at the time of filing the initial application.
    Response: Section 1.78(f)(2)(i) requires that the related 
applications must have the same claimed filing or priority date in 
addition to being commonly owned with one inventor in common and with 
substantial overlapping disclosure. Multiple patent applications 
related to the same product are not precluded by Sec.  1.78(f)(2). In 
the situation where Sec.  1.78(f)(2)(i) actually applies and the 
multiple applications relate to patentably distinct features of the 
same new product, it should not be difficult to explain how the 
applications contain patentably distinct claims under Sec.  
1.78(f)(2)(ii)(A), and thereby rebut the presumption. Thus, the 
presumption of Sec.  1.78(f)(2)(i) does not impose an undue burden on 
inventors.
    None of the criteria under Sec.  1.78(f)(1) for identifying certain 
related applications has anything to do with claims that could be filed 
in the initial application as suggested by the comment. Instead, Sec.  
1.78(f)(1) merely requires identification of applications that meet the 
identified criteria. Accordingly, there is no such burden placed on 
applicants.
    Comment 114: Several comments requested clarification of the 
language ``taking into account any filing date for which a benefit is 
sought under title 35, United States Code,'' in Sec.  1.78(f)(1). Those 
comments also inquired whether this language includes provisional 
applications for which benefit is sought, merely the first 
nonprovisional application for which benefit is sought, or every 
nonprovisional application for which benefit is sought.
    Response: Section 1.78(f)(1) requires applicant to consider all 
provisional, nonprovisional, international, and foreign applications 
for which benefit is sought. If the filing date of an application whose 
benefit is claimed in a nonprovisional application is within two months 
of the filing date of another pending nonprovisional application, and 
the nonprovisional applications name at least one inventor in common 
and are owned by the same person or subject to an obligation of 
assignment to the same person, each applicant of the nonprovisional 
applications must identify the other nonprovisional application to the 
Office. For example, if two nonprovisional applications claim priority 
of the same foreign application (or two foreign applications filed 
within two months of each other), name at least one inventor in common, 
and are owned by the same person, then each applicant of the 
nonprovisional applications must identify the other nonprovisional 
application, no matter the difference in time between their U.S. filing 
dates.
    Comment 115: A number of comments suggested that Sec.  1.78(f)(1) 
could be eliminated if the Office assigned all related applications to 
the same examiner.
    Response: The Office attempts to assign related applications to the 
same examiner where possible. However, applicant is in the best 
position to determine and identify when applications are related, not 
the Office. By meeting the provisions of Sec.  1.78(f), applicants will 
reduce the burden on the Office to identify which applications are 
related and facilitate examination of the related application by the 
examiner.
    Comment 116: Several comments suggested that Sec.  1.78(f)(1) would 
be burdensome to applicants who file a large number of applications in 
related areas of research. These comments suggested that the examiners 
working in these areas of technology will also experience a significant 
burden. A number of comments suggested that the Office has not 
sufficiently justified how the benefits of Sec.  1.78(f) outweigh the 
added costs for both applicants and the Office. These comments 
suggested that the existing rules relating to double patenting and the 
filing of terminal disclaimers are sufficient to solve the problems of 
patentably distinct claims, and that the Office's searchable database 
of applications makes the Sec.  1.78(f) changes unnecessary. The 
comments argued that examiners can perform common inventor searches as 
easily as applicants. A number of comments doubted the Office's 
reasoning that duplicative applications containing ``conflicting or 
patentably indistinct claims'' are having a crippling effect on the 
Office's ability to examine non-continuing applications. A number of 
comments making such an objection

[[Page 46781]]

stated that in fiscal year 2005, less than three percent of the patents 
granted contained a terminal disclaimer, and accordingly there is no 
basis for the rebuttable presumption of patentably indistinct claims. 
One comment suggested that Sec.  1.78(f)(2) would not reduce examiner 
workloads because examiners would still be required to make their own 
separate determinations regarding whether claims are patentably 
distinct in order to evaluate and address arguments made by applicants 
pursuant to Sec.  1.78(f)(2).
    Response: Multiple applications with patentably indistinct claims 
divert patent examining resources from the examination of new 
applications. This final rule encourages applicants to submit all of 
the claims that are patentably indistinct in one single application. 
See Sec. Sec.  1.78(f) and 1.75(b)(4). By presenting all of the 
patentably indistinct claims in one application, applicants can 
alleviate the Office's burden of searching for multiple applications 
containing patentably indistinct claims, analyzing the applications for 
double patenting issues, and requiring cancellation of the claims or a 
terminal disclaimer. This will also ensure that one single examiner 
will examine the same invention to provide consistent and focused 
examination. Furthermore, it will preclude applicant from submitting 
multiple applications to the same subject matter (with claims that are 
patentably indistinct), each with five or fewer independent claims or 
twenty-five or fewer total claims, for the purpose of avoiding the 
requirement to submit an examination support document.
    It is envisioned that many applicants will be proactive by filing 
fewer applications containing patentably indistinct claims, unless 
there is a good and sufficient reason to do so. By minimizing such 
filings, applicants will reduce the Office's burden of examining 
multiple applications containing patentably indistinct claims. 
Applicants are in a far better position than the Office to identify 
related applications pursuant to Sec.  1.78(f)(1). The Office's 
searchable database is not a sufficient substitute for applicant's 
knowledge of related applications, particularly in view of the fact 
that ownership identification is not required when an application is 
filed, and the fact that applications are often filed without executed 
declarations that correctly name all of the inventors.
    The terminal disclaimer statistic cited in the comment covers all 
granted patents. It does not specifically relate to the limited 
situation covered by Sec.  1.78(f)(2). Furthermore, double patenting 
issues must be considered in every application where the applicant 
filed another related application, not only those applications in which 
applicant filed a terminal disclaimer. For example, the statistic cited 
in the comment does not include applications in which the applicants 
canceled the patentably indistinct claims.
    The burden on the examiner to evaluate arguments presented by 
applicant is less compared to the burden of independently identifying 
and reviewing each application that meets the criteria set forth in 
Sec.  1.78(f)(2). Furthermore, the issues would be resolved earlier in 
the prosecution. Without the presumption of at least one patentably 
indistinct claim and applicant's assistance under Sec.  1.78(f)(2), it 
is more difficult to resolve potential double patenting situations.
    Comment 117: Several comments suggested that the two-month window 
between filing dates set forth in Sec.  1.78(f)(1) is overly burdensome 
on both the Office and the applicant.
    Response: The identification requirement under Sec.  1.78(f)(1) is 
consistent with the duty to disclose information that is material to 
patentability under Sec.  1.56. The two-month window set forth in Sec.  
1.78(f)(1) merely provides guidance to applicants for at least those 
applications that must be identified to the Office. Often, related 
applications filed outside the two-month window should also be 
identified to the Office under Sec.  1.56.
    Comment 118: One comment stated that compliance with Sec.  
1.78(f)(1) would be difficult for corporations that employ multiple law 
firms to handle their patent prosecution portfolios.
    Response: Each corporation typically has a person or a group of 
people who oversees its outside counsel and manages its patent 
portfolio. It is not unreasonable for the Office to assume that the 
person(s) managing the patent portfolio is aware of the contents of the 
corporation's applications being prosecuted by different law firms. In 
any event, it is appropriate for the corporation to bear the burden of 
tracking applications for compliance with Sec.  1.78(f)(1).
    Comment 119: One comment suggested that some docketing systems 
currently used by practitioners do not permit searching by inventor 
names in a manner that would enable practitioners to identify 
applications with common inventors that were filed within two months of 
each other.
    Response: The fact that some practitioners do not have a docketing 
system to identify applications with common inventors that were filed 
within two months of each other is not a sufficient reason for the 
Office to not require the information under Sec.  1.78(f)(1) that would 
assist the Office in identifying applications that potentially have 
double patenting issues. Practitioners should have the required 
information even though their docketing system may not keep track of 
applications with common inventors. Practitioners should have more 
reliable information regarding applications with common inventors than 
the Office's database because many applications are filed without an 
executed oath or declaration and the actual inventors are not often 
identified to the Office for a number of months after the filing date. 
Furthermore, ownership is not required to be identified when an 
application is filed.
    Comment 120: One comment questioned whether extensions of time 
would be available for applicants attempting to comply with the 
requirements of Sec.  1.78(f)(1).
    Response: Section 1.78(i) as adopted in this final rule provides 
that ``[t]he time periods set forth in [Sec.  1.78] are not 
extendable.''
    Comment 121: A number of comments questioned why applicants would 
need to identify to the Office applications with a common inventor 
under Sec.  1.78(f)(1) that contain patentably distinct claims because 
those applications are not candidates for an obviousness-type double 
patenting rejection.
    Response: Applicant is in the best position to identify to the 
Office applications with potentially conflicting claims. By taking 
responsibility for identifying such applications, applicant will be 
reducing the burden on the Office so that the Office can focus its 
limited examining resources on examining new applications. The ultimate 
determination of obviousness-type double patenting remains with the 
Office, which is why it is critical that applications that meet the 
criteria of Sec.  1.78(f)(1) be identified to the Office.
    Comment 122: A number of comments suggested that while an applicant 
is in a better position to know of related applications that have been 
filed, they are not in the position to determine whether the claims of 
these applications are patentably distinct. This is a function of the 
Office. One comment argued that the Office is making an unsupported 
assumption that the applicant is in a far better position than the 
Office to determine whether there are one or more other applications or 
patents containing patentably indistinct claims.

[[Page 46782]]

    Response: The applications whose specifications possibly contain 
patentably indistinct claims were made by or on behalf of the inventor 
or applicant, and not the Office or the examiner. See 35 U.S.C. 111(a). 
Thus, the applicant is in a better position than the Office or examiner 
to know when such related applications have been filed. While the 
ultimate determinations of double patenting and patentability remain 
with the Office, the Office rejects the position that the applicant has 
no responsibility to facilitate those decisions. The information 
provided by applicant in compliance with Sec.  1.78(f)(1) is reasonably 
necessary for the Office to determine double patenting issues. With the 
information provided before the first Office action on the merits, the 
Office could make the patentability determination more efficiently and 
thereby reduce pendency. For example, the examiner could identify and 
resolve any double patenting issues earlier in the prosecution.
    Comment 123: One comment suggested that the requirements of Sec.  
1.78(f)(1) would raise inventorship and ownership issues when entities 
have entered into a confidential research agreement.
    Response: The identification of such applications is reasonably 
necessary for an efficient and effective examination. This requirement 
is similar to that imposed upon applicants having knowledge of material 
prior art that became known to them via information covered by a 
confidentiality agreement. In such an instance, the existence of a 
confidentiality agreement does not relieve applicants from their duty 
to disclose this prior art information to the Office. In any event, 
Sec.  1.78(f)(1) requires identification of only the commonly owned 
applications (if certain conditions are met), but not identification of 
the owner. 35 U.S.C. 115 requires that the inventors identify 
themselves.
    Comment 124: One comment suggested that Sec.  1.78(f) will have the 
greatest adverse impact on small entities.
    Response: The rules apply equally to both non-small entities and 
small entities. The comment did not provide persuasive data or other 
evidence supporting the conclusion. The Office's experience is that 
small entities do not file a larger percentage of multiple applications 
than non-small entities. Thus, it is doubtful that any impact, if 
adverse, will affect small entities the most.
    Comment 125: Several comments questioned whether the Office should 
even concern itself with obviousness-type double patenting rejections. 
They suggested that essentially no harm at all to the public exists 
through the grant of plural applications having the same, or roughly 
the same, filing dates, while the technical traps for the unwary and 
the undue examination burdens established by double patenting 
rejections unduly complicate procurement and burden the Office.
    Response: There are two reasons why the Office still needs to make 
obviousness-type double patenting rejections in applications filed on 
or after June 8, 1995, and that are subject to a twenty-year term under 
35 U.S.C. 154(a)(2). First, 35 U.S.C. 154 does not ensure that any 
patent issuing on a utility or plant application will necessarily 
expire twenty years from the earliest filing date for which a benefit 
is claimed under 35 U.S.C. 120, 121, or 365(c) because 35 U.S.C. 154(b) 
includes provisions for patent term extension based upon prosecution 
delays during the application process. Second, Sec.  1.321(c)(3) 
requires that a terminal disclaimer filed to obviate an obviousness-
type double patenting rejection based on commonly owned patentably 
indistinct claims include a provision that any patent granted on that 
application be enforceable only for and during the period that the 
patent is commonly owned with the application or patent which formed 
the bases for the rejection. This requirement prevents the potential 
for harassment of an accused infringer by multiple parties with patents 
covering the same patentable invention. See MPEP Sec.  804.02. If 
applicant files all of the patentably indistinct claims in one 
application, applicant could alleviate the Office's burden of searching 
for multiple applications containing patentably indistinct claims, 
analyzing the applications for double patenting issues, and requiring 
cancellation of the claims or a terminal disclaimer.
    Comment 126: One comment suggested that Sec.  1.78(f)(2) prevents 
an applicant from claiming different embodiments unless the embodiments 
are patentably distinct.
    Response: Under this final rule, applicant may present claims 
during the prosecution of an initial application and two continuation 
or continuation-in-part applications plus one request for continued 
examination in the application family, without any justification. 
Applicant therefore should have sufficient opportunity to present 
claims to different embodiments of an invention in these filings. 
Furthermore, applicant is not required to provide an explanation under 
Sec.  1.78(f)(2)(ii)(B) for a continuation application or continuation-
in-part application of a prior-filed application that has been allowed.
    Comment 127: One comment suggested that examiners would not have 
any incentive to find claims patentably distinct.
    Response: Examiners are professionals who perform their duties 
within the framework of the current patent laws, rules and examination 
practices. No persuasive explanation was given in support of the 
suggestion that examiners would be less likely to find claims 
patentably distinct.
    Comment 128: One comment suggested that the rebuttable presumption 
set forth in Sec.  1.78(f)(2) was inconsistent with the Office's 
restriction practice. The comment suggested that it was inconsistent to 
presume that claims are patentably indistinct when, if the claims were 
filed in one application, they would be found to be patentably 
distinct, and subject to a restriction requirement.
    Response: The changes to Sec.  1.78(f)(2) and restriction practice 
encourage applicant to file a single application for each patentably 
distinct invention. For example, if two or more independent and 
distinct inventions are claimed in a single application, the examiner 
may make a restriction requirement. See Sec.  1.142. The filing of 
multiple applications that together claim only one patentable invention 
(i.e., the applications contain patentably indistinct claims), however, 
is diverting the Office's limited examining resources from examining 
new applications. Applicant should file a single application claiming 
one patentable invention rather than multiple applications claiming the 
same patentable invention. Applicant may rebut the presumption that 
claims in multiple applications are not patentably distinct by 
explaining how the application contains only claims that are patentably 
distinct from the claims in each of the other applications. Similar to 
the restriction practice, applicant may maintain multiple applications 
if the applications contain patentably distinct claims (i.e., each 
application is claiming one patentably distinct invention).
    Comment 129: One comment objected that remarks by applicants under 
Sec.  1.78(f)(2) to rebut the double patenting presumption would create 
prosecution history estoppel before the Office issued a rejection that 
could impact on the certainty and quality of the patent.
    Response: First, applicant remarks under Sec.  1.78(f)(2) would be 
akin to remarks set forth in response to a double

[[Page 46783]]

patenting rejection. The Office does not consider the possibility of 
prosecution history estoppel to be a sufficient reason to forego the 
presumption built into Sec.  1.78(f)(2). Second, such remarks would not 
be required if all patentably indistinct claims are included in one 
application.
    Comment 130: One comment suggested that the rebuttable presumption 
in Sec.  1.78(f)(2) would require applicants who normally file multiple 
utility applications within two months of each other, each with more 
than the threshold number of claims and each claiming benefit of the 
same provisional application, to now file an examination support 
document for their applications. The comment suggested that this would 
be especially true for those applications forming a portfolio being 
developed for a new technology.
    Response: The rebuttable presumption provision of Sec.  1.78(f)(2) 
would apply only if the nonprovisional applications have the same 
filing date, taking into account any filing date for which a benefit is 
sought, name at least one inventor in common, are owned by the same 
person or are subject to an obligation of assignment to the same 
person, and contain substantial overlapping disclosure. The rebuttable 
presumption provision of Sec.  1.78(f)(2) does not apply simply because 
commonly owned applications are filed within two months of each other. 
In addition, Sec.  1.78(f)(2) provides for a rebuttable presumption 
that applications contain patentably indistinct claims. The 
applications thus will be treated as containing patentably indistinct 
claims for claim counting purposes under Sec.  1.75(b)(4) if the 
applicant does not explain how the applications do not contain 
patentably indistinct claims or if the examiner does not agree with the 
explanation. If an applicant files multiple applications that contain 
patentably indistinct claims, there is no reason why the Office should 
treat an applicant who spreads patentably indistinct claims among 
multiple applications differently than an applicant who presents all of 
the patentably indistinct claims in a single application.
    Comment 131: Several comments suggested that the filing of multiple 
applications having at least one common inventor and specifications 
with overlapping disclosures cannot be presumed to be bad faith 
prosecution because these applications typically claim distinct 
inventions that relate to the same product or service and such 
applications are not used to delay prosecution. One such comment stated 
that the rebuttable presumption under Sec.  1.78(f)(2) represents an 
overreaction to tactics engaged in by a small minority of applicants. 
Another such comment took offense to Sec.  1.78(f)(2) as appearing to 
be based on underlying presumptions that applicants are gaming the 
system and their representatives are acting in bad faith whenever 
applications are filed meeting the criteria of the rule.
    Response: There is no presumption of bad faith on the part of 
applicant. The rebuttable presumption is simply a procedural tool 
requiring the applicant to help focus and consolidate the examination 
process. This will help examiners to resolve double patenting issues 
early in the examination process and contribute to examination 
efficiency by eliminating the need to search for related applications.
    Comment 132: A number of comments stated that the Sec.  1.78(f)(2) 
criteria do not automatically lead to the conclusion the claims are 
patentably indistinct and that applicants may easily maintain multiple 
applications by preparing claims that are uniquely supported only in 
the application in which they appear. One comment objected that the 
mere presence of specifications with overlapping disclosures does not 
create a prima facie case of patentably indistinct claims as evidenced 
by the fact that an obviousness-type double patenting rejection 
requires a comparison between the claims of the application being 
examined and those of the co-owned application or patent, not a 
comparison of their disclosures.
    Response: The Sec.  1.78(f)(2) criteria lead to a rebuttable 
presumption, which is rebuttable that patentably indistinct claims 
exist. The rebuttable presumption is not a merits determination of 
patentability, but is simply a procedural tool requiring the applicant 
to help focus and consolidate the examination process. Further, an 
overlapping disclosure is not the only condition for the presumption 
under Sec.  1.78(f)(2). Section 1.78(f)(2) also specifies that the 
applications must have the same claimed filing or priority date, name 
at least one inventor in common, and have common ownership. 
Accordingly, the presumption is limited so that it only applies to 
applications that most likely contain patentably indistinct claims. The 
rebuttable presumption does not equate to a prima facie case of 
patentably indistinct claims. An applicant may rebut the presumption by 
explaining how the application contains claims that are patentably 
distinct from the claims in each of the other applications or patents. 
If the applicant cannot rebut the presumption, applicant must submit a 
terminal disclaimer in accordance with Sec.  1.321(c) and explain why 
there are two or more pending nonprovisional applications which contain 
patentably indistinct claims.
    Comment 133: One comment suggested that the rebuttable presumption 
should be provisional as the scope of the claims in question may change 
during the course of prosecution.
    Response: Section 1.78(f)(2) as adopted in this final rule requires 
the appropriate action within the later of: (1) Four months from the 
actual filing date of an application filed under 35 U.S.C. 111(a) or 
four months from the date on which the national stage commenced under 
35 U.S.C. 371(b) or (f); or (2) the date on which a claim that is not 
patentably distinct from at least one of the claims in the other 
applications is presented. For example, if the presumption under Sec.  
1.78(f)(2) applies, applicant must rebut this presumption within four 
months from the actual filing date of an application filed under 35 
U.S.C. 111(a) for the original claims presented on the filing date of 
the application. If applicant subsequently files an amendment that adds 
a new claim after four months from the filing date of the application, 
applicant must rebut this presumption for such a claim when applicant 
files the amendment.
    Comment 134: One comment suggested that since the Office has stated 
in MPEP Sec.  804.02 that patent applications which give rise to 
obviousness-type double patenting rejections are in the public 
interest, it stands to reason that the rules that seek to preclude such 
applications are against public interest.
    Response: The Office stated that the use of a terminal disclaimer 
in overcoming an obviousness-type double patenting rejection is in the 
public interest because it encourages the disclosure of additional 
developments, the earlier filing of applications, and the earlier 
expiration of patents whereby the inventions covered become freely 
available to the public. See MPEP Sec.  804.02. The Office did not 
state that the public interest was served by all applications that 
contain patentably indistinct claims.
    Comment 135: One comment questioned whether applications subject to 
the requirements of Sec.  1.78(f)(2) would increase examination 
pendency or add to the Office's backlog since the rejections set forth 
in applications with patentably indistinct claims are typically 
overcome by a properly drafted terminal disclaimer.

[[Page 46784]]

    Response: The changes to Sec.  1.78(f)(2) in this final rule are 
aimed at reducing pendency and the Office's backlog. Specifically, 
Sec.  1.78(f)(2) requires applicant to resolve the double patenting 
issues early in the prosecution (e.g., four months from the actual 
filing date of the application) by either: (1) Filing a terminal 
disclaimer and an explanation as to why the multiple applications 
containing patentably indistinct claims are necessary; or (2) 
explaining how the application contains only claims that are patentably 
distinct from the claims of other related applications. Therefore, 
double patenting issues could be resolved before the first Office 
action on the merits, thus saving the examiner time by eliminating the 
need to search for related applications, analyze the potentially 
conflicting claims, and make the rejection. As a result, examination 
can be more focused on prior art and other patentability issues.
    Without the rebuttable presumption of Sec.  1.78(f)(2), it would be 
harder for the examiner to identify and resolve the potential double 
patenting situation. In addition, if an Office action in an application 
to which the rebuttable presumption applies must include a double 
patenting rejection, it is because the applicant has not helped to 
resolve the double patenting situation pursuant to Sec.  1.78(f)(2). 
Accordingly, a double patenting rejection made for the first time in a 
second or subsequent Office action will not preclude the Office action 
from being made final (assuming that the conditions for making a second 
or subsequent action final are otherwise met). Thus, applicants' 
responsibility to take the initiative under Sec.  1.78(f)(2) to resolve 
double patenting situations will expedite examination, even if this 
responsibility does not result in the prompt resolution of the double 
patenting situation. Further, the Office envisions that many applicants 
will file fewer applications containing patentably indistinct claims in 
light of Sec.  1.78(f)(2) unless there is a good and sufficient reason 
to do so. Therefore, the Office expects that the requirements of Sec.  
1.78(f)(2) will not increase examination pendency or add to the Office 
backlog.
    Comment 136: One comment suggested that the strategy for 
circumventing the claim requirement set forth in Sec.  1.75 by filing 
multiple applications in order to receive substantive examination on 
more than the threshold number of claims conflicts with Sec.  
1.78(f)(2).
    Response: As suggested by the comment, some applicants might 
attempt to circumvent the requirements in Sec.  1.75(b)(1) by filing 
multiple applications. Such a strategy would be ineffective as a result 
of the provisions of Sec.  1.75(b)(4) and Sec.  1.78(f). For the 
purpose of determining whether each of the multiple applications 
exceeds the five independent claim and twenty-five total claim 
threshold, the Office will treat each application as having the total 
number of all of the claims (whether in independent or dependent form) 
from all of the multiple applications. See Sec.  1.75(b)(4).
    Comment 137: Several comments objected that applicants are being 
required to explain or justify why they are filing patent applications. 
Some of the comments stated that such a requirement is unnecessarily 
burdensome and forces applicants to make statements that could lead to 
prosecution history estoppel issues. One of the comments questioned why 
Sec.  1.78(f)(2)(ii) requires applicants to explain why the filing of 
two applications is necessary if a terminal disclaimer has been filed.
    Response: The filing of multiple applications containing patentably 
indistinct claims is impairing the Office's ability to examine new 
applications. Applicant has the opportunity to avoid drafting and 
filing applications that satisfy the criteria of Sec.  1.78(f)(2) by 
filing a single application containing all of the patentably indistinct 
claims. Furthermore, Sec.  1.78(f)(2)(i) gives applicant the option to 
rebut the presumption of patentably indistinct claims rather than 
filing a terminal disclaimer and an explanation. Also note that the 
Sec.  1.78(f)(3) provision was similarly set forth in former Sec.  
1.78(b).
    Comment 138: Several comments were critical of Sec.  1.78(f)(2) and 
stated that the rule would merely result in applicants filing jumbo 
patent applications with multiple claim sets drawn to patentably 
distinct inventions in order to force the Office to issue restrictions 
instead of filing multiple applications on the same day that meet the 
criteria of Sec.  1.78(f)(2).
    Response: Section 1.78(f)(2) permits applicant to file multiple 
applications claiming patentably distinct inventions. Applicant may 
rebut the presumption by arguing that the applications claim patentably 
distinct inventions. Applicant also has the option of filing a single 
application to claim patentably distinct inventions or when applicant 
is unsure whether the inventions are patentably distinct. As noted in 
Berg, 140 F.3d at 1434, 46 U.S.P.Q.2d at 1231, applicants achieve no 
advantage by choosing to file patentably indistinct claims in separate 
applications because the claims would be subject to a rejection under 
the one-way double patenting analysis. The Berg court stated that 
``[i]f a potential applicant is unsure whether it has more than one 
patentably distinct set of claims, the PTO advises that it file all of 
the claims as one application.'' See id. at 1435, 46 U.S.P.Q.2d at 
1232. The option presented by the Office was considered by the court to 
be reasonable, notwithstanding the possibility that the examiner might 
not make a restriction requirement.
    Comment 139: One comment suggested that applicants will be unfairly 
disadvantaged if they fail to convince the examiner that the claims are 
patentably distinct, as they will likely be simultaneously subject to a 
final rejection with the probability of just a single continuation 
application to gain allowance of the claims.
    Response: This final rule permits applicant to file two 
continuation or continuation-in-part applications and one request for 
continued examination in an application family, without any 
justification. If a timely rebuttal under Sec.  1.78(f)(2) is filed 
before the application is taken up for initial examination, the 
applicant will not be subject to a final rejection in the first Office 
action on the merits. Only if the rebuttal is not timely filed would 
the applicant be subject to a final rejection in the succeeding Office 
action in the event the examiner makes a determination of patentably 
indistinct claims.
    Comment 140: One comment stated that the Sec.  1.78(f)(2) 
rebuttable presumption of patentably indistinct claims is overreaching 
and its burden on the applicant cannot be justified since it is very 
common for an applicant to file multiple applications having a single 
specification and patentably distinct claims drawn to different 
inventions.
    Response: The rebuttable presumption of Sec.  1.78(f)(2) is not 
overreaching as it applies only to applications that have the same 
filing date, taking into account any filing date for which a benefit is 
sought, name at least one inventor in common, are owned by the same 
person or are subject to an obligation of assignment to the same 
person, and contain substantial overlapping disclosure. Thus, it 
applies only to applications that most likely contain patentably 
indistinct claims. Applicant who files multiple applications claiming 
patentably distinct inventions may simply rebut the presumption. 
Applicant also has the option of filing a single application to claim 
patentably distinct inventions or when applicant is unsure whether the 
inventions are patentably distinct. If an

[[Page 46785]]

application claims two or more independent and distinct inventions, the 
examiner may make a restriction requirement. See Sec.  1.142.
    Comment 141: Several comments requested clarification as to the 
standard for ``patentably indistinct'' as the term appears in Sec.  
1.78 and whether this applies to ``same invention'' double patenting 
under 35 U.S.C. 101, or ``obviousness-type'' double patenting, or 
something different. Several comments requested clarification 
concerning what would be an adequate explanation under Sec.  
1.78(f)(2)(i) to rebut the presumption of patentably indistinct claims.
    Response: The standard for ``patentably indistinct'' as the term 
appears in Sec.  1.78 is one-way distinctness in an obviousness-type 
double patenting analysis. See MPEP Sec.  804(II)(B)(1)(a). The 
presumption under Sec.  1.78(f)(2) may be rebutted by showing that the 
application claims are directed to a separate invention, or by pointing 
to a unique claim element(s) in the independent claim(s) that 
patentably distinguishes them from the claims in the application(s) 
that gave rise to the Sec.  1.78(f)(2) presumption.
    Comment 142: A number of comments questioned whether all patentably 
indistinct claims in multiple applications meeting the conditions of 
Sec.  1.78(f)(2) are required to be submitted in a single application 
absent good and sufficient reason.
    Response: If all patentably indistinct claims can be filed in a 
single application and there is no good and sufficient reason for the 
patentably indistinct claims to be filed in multiple applications, then 
applicant should file the patentably indistinct claims in a single 
application. Section 1.78(f)(3) provides that the Office may require 
elimination of the patentably indistinct claims meeting the conditions 
of Sec.  1.78(f)(3) in all but one of the applications in the absence 
of a good and sufficient reason for there being two or more 
applications containing patentably indistinct claims.
    Comment 143: Several comments suggested that Sec.  1.78(f)(2) be 
changed to provide that the presumption of patentably indistinct claims 
be applied to all related applications only when a double patenting 
rejection is made in one of the related applications.
    Response: The suggested change would delay triggering the 
presumption of patentably indistinct claims and not help reduce the 
burden on examiners with respect to reviewing and analyzing related 
applications with potentially conflicting claims.
    Comment 144: One comment stated that by requiring more than a 
terminal disclaimer to overcome an obviousness-type double patenting 
rejection, the Office is outside its authority.
    Response: No more than a terminal disclaimer is required to 
overcome obviousness-type double patenting if the reference is a 
patent. However, if the obviousness-type double patenting reference is 
a pending application, consideration of patentably indistinct claims 
can be expedited in a single application. Such a requirement is 
consistent with the Office's statutory authority under 35 U.S.C. 
2(b)(2). Nothing in the patent statutes requires the Office to accept 
patentably indistinct claims in multiple applications absent a good and 
sufficient reason.
    Comment 145: Several comments suggested eliminating the presumption 
of double patenting in Sec.  1.78(f)(2) and identification of similar 
applications in Sec.  1.78(f)(1) as such requirements are already in 
the rules.
    Response: The former rules of practice did not expressly require 
the identification of applications based on filing dates, inventorship 
and ownership conditions. Some of the applications identified pursuant 
to Sec.  1.78(f)(1) may be applications with the potential to be 
material to patentability as prosecution progresses. Section 1.78(f)(2) 
as adopted in this final rule explicitly sets forth for the first time 
a presumption of patentably indistinct claims among related 
applications meeting certain conditions.
    Comment 146: Several comments suggested permitting ``voluntary'' 
divisional applications instead of requiring an explanation adequate to 
rebut the Sec.  1.78(f)(2) presumption of patentably indistinct claims.
    Response: It is unclear how such a strategy would reduce pendency 
and promote quality. Anytime a terminal disclaimer is filed under the 
conditions of Sec.  1.78(f)(2), the applicant would also have to file a 
satisfactory explanation of why there are two or more commonly owned 
pending nonprovisional applications naming at least one inventor in 
common which contain patentably indistinct claims. The alternative to 
filing a terminal disclaimer with the explanation is to rebut the Sec.  
1.78(f)(2) presumption with a showing that the application contains 
only patentably distinct claims.
    Comment 147: Several comments requested clarification as to what 
constitutes ``substantial overlapping disclosure'' and whether it 
encompasses, for example, a single common sentence or disclosed 
element, or an incorporation by reference to another application.
    Response: As discussed previously, Sec.  1.78(f)(2)(i) provides 
that substantial overlapping disclosure exists if the other pending or 
patented nonprovisional application has written description support 
under 35 U.S.C. 112, ] 1, for at least one claim in the nonprovisional 
application. This written description support may be either by express 
disclosure or by an incorporation by reference to another application. 
A single common sentence or disclosed element most likely would not, by 
itself, constitute ``substantial overlapping disclosure.''
    Comment 148: One comment was critical that Sec.  1.78(f)(2)(i) will 
force applicants to prove a negative in order to show that there are no 
patentably indistinct claims among the pending nonprovisional 
applications.
    Response: To rebut the presumption under 1.78(f)(2)(i), applicant 
could identify claim elements that patentably distinguish the 
applications from one another. It is not required that the applicant 
prove a negative.
    Comment 149: Several comments objected that Sec.  1.78(f)(3) could 
effectively promote a ban on continuation applications with patentably 
indistinct claims, and may unnecessarily limit claim broadening in 
continuation applications.
    Response: Section 1.78(f)(3) is a restatement of former Sec.  
1.78(b), which previously gave the Office the same discretion to 
require elimination of patentably indistinct claims in all but one of 
the pending nonprovisional applications. The only difference is that 
the Office will now have the benefit of Sec.  1.78(f)(2)(i) to evaluate 
when to properly exercise that discretion.
    Comment 150: A number of comments noted that Sec.  1.78(f)(3) 
essentially restates former Sec.  1.78(b) and questioned whether Sec.  
1.78(f)(3) would achieve anything beyond what former Sec.  1.78(b) 
achieved during its existence for over thirty-five years.
    Response: This provision will be more effectively utilized with the 
other changes to Sec.  1.78(f).
    Comment 151: A number of comments requested clarification of the 
procedure for reviewing a determination of multiple applications with 
patentably indistinct claims. One comment requested clarification as to 
whether an adverse determination is redressed by way of appeal to the 
BPAI or to a district court.
    Response: Applicants may petition the Director for review of 
administrative requirements by an examiner or other Office official, 
such as a requirement for

[[Page 46786]]

an examination support document under Sec.  1.265 when claims in 
multiple applications are determined to be patentably indistinct thus 
causing the involved applications to exceed the five independent claim 
and twenty-five total claim threshold set forth in Sec. Sec.  
1.75(b)(1), (b)(3), and (b)(4), as well as a requirement that claims in 
multiple applications that are determined to be patentably indistinct 
be canceled from all but one application.
    The BPAI's jurisdiction and appeal procedure in general has not 
been changed as a result of this final rule. As before, applicant may 
appeal the decision of the examiner to the BPAI under 35 U.S.C. 134 and 
Sec.  41.31 if at least one claim has been twice rejected (see Sec.  
41.31(a)), including an obviousness-type double patenting rejection.
    Comment 152: A number of comments were critical of the ``may 
require elimination'' in Sec.  1.78(f)(3), suggesting that the 
discretion would be arbitrarily applied by individual examiners and 
inconsistently applied by the Patent Examining Corps. Some comments 
requested clarification of the procedure and questioned whether the 
Office will make a double patenting rejection and/or require 
elimination of patentably indistinct claims. Some comments questioned 
whether a requirement to eliminate patentably indistinct claims would 
apply to all but a single application.
    Response: Section 1.78(f)(3) provides that, in the absence of good 
and sufficient reason for there being multiple commonly owned 
applications that contain patentably indistinct claims, the Office may 
require elimination of the patentably indistinct claims from all but 
one of the applications. The term ``may'' provides both the Office and 
applicants with the necessary discretion and flexibility either to 
eliminate the identified claims found to be patentably indistinct, or 
to merge multiple applications into one. Substantively, Sec.  
1.78(f)(3) is a restatement of former Sec.  1.78(b).
    Comment 153: A number of comments stated that requirements to 
eliminate patentably indistinct claims from all but one of the 
applications will lead to applicant appeals or petitions before 
examination resulting in a substantial increase in pendency while 
consuming Office and applicant resources. Some comments stated that 
Sec.  1.78(f)(3) requirements will discourage applicants from 
acknowledging claims that are patentably indistinct and result in 
increased challenges to double patenting rejections.
    Response: As discussed previously, it is envisioned that many 
applicants will file fewer applications containing patentably 
indistinct claims unless there is a good and sufficient reason to do 
so. Because any requirement under Sec.  1.78(f)(3) would be made during 
examination, there can be no petitions to the Director, or appeals, 
filed before examination as suggested by the comment. The comment 
provided no reasoning as to why Sec.  1.78(f)(3) would have the 
negative impact anticipated by the comment when Sec.  1.78(f)(3) is a 
restatement of former Sec.  1.78(b).
    Comment 154: One comment suggested allowing multiple related 
applications, keeping the requirement to identify related applications, 
and adding a requirement for applicant to briefly explain the subject 
matter claimed in each related application.
    Response: The proposed solution would not meet the objectives of 
these rules and would not prevent the Office from unnecessarily 
expending the Office's resources in the examination of multiple 
applications with patentably indistinct claims.
    Comment 155: Several comments questioned whether excess claim fees 
would be refunded upon elimination of patentably indistinct claims 
pursuant to Sec.  1.78(f)(3).
    Response: Applicant may request a refund of any excess claims fees 
paid on or after December 8, 2004, if applicant cancels the claim 
before an examination on the merits has been made of the application. 
See Sec.  1.117.
    Comment 156: Several comments questioned why there is different 
language in Sec. Sec.  1.78(f)(3) and 1.75(b)(4), and questioned 
whether the language should be the same.
    Response: As the comment noted, the proposed provisions that the 
Office may require elimination of the patentably indistinct claims from 
all but one of the applications in Sec. Sec.  1.78(f)(3) and 1.75(b)(4) 
were duplicative and might have appeared different. In view of the 
comment, the Office did not adopt the proposed provision that the 
Office may require elimination of the patentably indistinct claims from 
all but one of the applications in Sec.  1.75(b)(4). The Office adopted 
this provision in Sec.  1.78(f)(3) which is substantively a restatement 
of former Sec.  1.78(b). See the discussion of Sec. Sec.  1.75(b)(4) 
and 1.78(f)(3).
    Comment 157: Several comments requested that implementation of 
Sec.  1.78(f)(3) be delayed until other rule changes can be evaluated.
    Response: Section 1.78(f)(3) is a restatement of former Sec.  
1.78(b) which has been in effect since April 30, 1971. See Conflicting 
Claims, 36 FR 7312 (April 17, 1971) (final rule).
    Comment 158: One comment stated that the patentably indistinct 
claims in multiple applications are a necessary and desirable component 
of United States patent law.
    Response: The comment did not provide a reason why the need for 
applicants to have separate applications with patentably indistinct 
claims outweighs the needs of the Office to reduce the resources 
exhausted during the examination of different applications with 
patentably indistinct claims.
    Comment 159: One comment stated that Sec.  1.78(f)(3) imposes an 
overly stringent standard that jeopardizes applicant's ability to 
ensure patented claims will be held valid if challenged during 
litigation. One comment stated that the Sec.  1.78(f) changes are based 
on the presumption that all patentably indistinct claims can be 
supported and examined in the same application, but that is not always 
the case.
    Response: Section 1.78(f)(3) is a restatement of former Sec.  
1.78(b), which previously gave the Office the same discretion to 
require elimination of patentably indistinct claims in all but one of 
the pending nonprovisional applications. Therefore, Sec.  1.78(f)(3) 
does not introduce a new standard as suggested in the comment. 
Applicant may file multiple applications, but applicant must, in each 
application, submit a terminal disclaimer in accordance with Sec.  
1.321(c) and explain why there are two or more pending nonprovisional 
applications containing patentably indistinct claims.
    Comment 160: One comment suggested allowing applicants to add 
patentably indistinct claims to an application after determination that 
an original set of claims is allowable.
    Response: Patentably indistinct claims should not be added to an 
application upon allowance of the original claims, but should instead 
be presented earlier.
    Comment 161: One comment questioned whether it is really a burden 
on the examiner to search two applications with patentably indistinct 
claims versus one application with the claims of both.
    Response: It is less burdensome to the Office to have patentably 
indistinct claims in a single application. A related application with 
conflicting claims would have to be identified, reviewed and analyzed 
for double patenting issues.
    Comment 162: One comment suggested providing for immediate and 
expedited review of all decisions

[[Page 46787]]

relating to new submissions required by Sec.  1.78.
    Response: The Office will strive to promptly act on all petitions 
related to the changes to Sec.  1.78 in this final rule.
    Comment 163: One comment suggested that Sec.  1.78(g) should be 
amended to require that in response to a statutory or obviousness-type 
double patenting rejection, the Office may require the assignee to 
state whether the claimed inventions were commonly owned or subject to 
an obligation of assignment to the same person at the time the later 
invention was made, and if not to indicate which named inventor(s) is/
are the prior inventor, unless applicant traverses the rejection.
    Response: Section 1.78(g) contains the provisions of former Sec.  
1.78(c). The Office believes that these provisions, as well as the 
information that may be required, are currently sufficient for the 
Office to achieve its goals with respect to identifying commonly owned 
cases that come within the provisions of 35 U.S.C. 103(c) or with 
respect to determining the prior invention.

F. Changes to Practice for Examination of Claims

    Comment 164: Several comments supported the concept of 
representative claims. One comment stated that the rules promote more 
focused examination, reduce delay and help conserve scarce Office 
resources, require little effort on the part of most applicants, and 
still make certain that no patent claims will issue without a complete 
examination. The comments also expressed support for limiting the 
number of claims that need to be examined and encouraged the Office to 
reduce overwhelming numbers of claims in favor of quality examinations. 
One comment suggested that the Office should adopt a rule that only 
independent claims are examined.
    A number of comments, however, argued in a variety of terms that 
the ``representative claims'' examination approach would lead to 
piecemeal examination and prolonged examination, would require 
additional searching when features from non-designated dependent claims 
are added to designated dependent or independent claims, and would lead 
to additional filings, increased appeals, and less thorough 
examination. Several comments suggested that the number of claims 
examined should not be limited per se because the line of novelty in a 
claim family often falls between the broad independent claims and the 
narrowest dependent claim. One comment stated that the ``representative 
claims'' examination approach may adversely affect the treatment given 
to dependent claims in court. One comment argued that the Office's 
statistics on applications having more than ten independent claims 
ignore how many total claims had to be presented to lead to those 
independent claims.
    Several comments argued that since excess claim fees have 
presumably been determined based on the resources necessary to carry 
out search and examination of all of the claims, it is not appropriate 
for the Office to neglect to fully search and examine the entire 
application for which all fees have been paid. One comment stated that 
there is no basis for limiting the consideration of a dependent claim 
during examination because under 35 U.S.C. 112, ] 4, a dependent claim 
is treated as a claim that incorporates all the limitations of the 
preceding claims.
    A number of comments argued that the ``representative claims'' 
examination approach may be appropriate in other proceedings (such as 
before the BPAI) or even during examination, but not before first 
Office action on the merits. One comment argued that statistical data 
from the appeal stage is misleading because there are fewer issues 
during an appeal than during prosecution of an application before the 
examiner. Several comments stated that the BPAI would be forced to 
perform examination on the merits of the non-representative claims.
    A number of comments suggested that the Office should address 
excessive claiming concerns in a simple and straightforward manner by 
limiting the number of claims permitted and fully examined under the 
basic fee structure to, for example, six independent and thirty total 
numbered claims, and allowing multiple dependent claims that depend on 
other multiple dependent claims. Several comments suggested that the 
Office specify that excess claims over a certain number will only be 
examined if accompanied by an independent search report, rather than 
burdening all applicants with the requirement to designate claims. 
Several comments suggested that instead of representative claims, 
applicants should be allowed to select claims that stand or fall 
together.
    Finally, a number of comments also raised implementation issues, 
requested clarification concerning implementation issues, or provided 
suggestions concerning the implementation of the ``representative 
claims'' examination approach.
    Response: As a result of the public comment, the Office is not 
adopting the ``representative claims'' examination approach under which 
the Office would limit the initial examination of an application to the 
``representative claims'' (the independent claims and the dependent 
claims that are expressly designated by the applicant for initial 
examination). The Office is instead making the presentation of more 
than five independent claims or more than twenty-five total claims 
(rather than the presentation of more than ten representative claims) 
the threshold for invoking the examination support document 
requirement. Thus, this final rule provides that if the number of 
independent claims is greater than five or the number of total claims 
is greater than twenty-five, the applicant must provide additional 
information to the Office in an examination support document covering 
all of the claims in the application (whether in independent or 
dependent form).
    Although, the ``representative claims'' examination approach is not 
being adopted, the Office disagrees that such an approach amounts to 
piecemeal examination or that it would be less efficient than the 
current examination process. Under such an approach, the Office would 
have examined a claim before applicant could seek review of any 
rejection of the claim on appeal, regardless of whether the claim was 
designated or non-designated under the ``representative claims'' 
examination approach.
    Regarding escalating fees, the Office previously proposed a system 
of escalating fees and it was overwhelmingly opposed by user groups. 
The Office has also determined that charging higher fees for large 
numbers of claims would likely still not result in the desired increase 
in quality since many applicants would simply pay the higher fees. 
Furthermore, claim fees are set by statute, not the Office. As 
discussed previously, 35 U.S.C. 112, ] 5, prohibits multiple dependent 
claims depending on other multiple dependent claims.
    Comment 165: One comment stated that examining many claims aids in 
understanding the invention.
    Response: The experience of those who actually examine applications 
is that examining a large number of claims does not aid in 
understanding the invention but rather obfuscates the invention. In 
addition, the issuance of patents containing an excessive number of 
claims has also long been considered an abuse of the courts and the 
public, rather than an aid in understanding the invention. See Carlton 
v. Bokee, 84 U.S. (17 Wall) 463, 471-72 (1873) (needless multiplication 
of nebulous claims deemed calculated to deceive and mislead the 
public); Wahpeton Canvas Co. v. Frontier, Inc., 870 F.2d 1546, 1551

[[Page 46788]]

n.6, 10 U.S.P.Q.2d 1201, 1206 n.6 (Fed. Cir. 1989) (presentation of the 
infringement issue on an overgrown claims jungle to a jury and judge at 
trial is an unprofessional exercise in obfuscation).
    Comment 166: A number of comments argued that more claims are 
needed to protect an applicant's invention adequately, especially in 
light of restrictions on the doctrine of equivalents, decisions by the 
Federal Circuit on unclaimed subject matter, the proposed limitations 
on continuation practice, and because the complexity of some inventions 
requires more claims to protect the subject matter appropriately. One 
comment argued that the effects of prosecution history estoppel and the 
constraints put on reissue applicants by the recapture doctrine demand 
a broad range of claims. Several comments argued that the proposed 
changes disproportionately affect the biotechnology and pharmaceutical 
industries. One comment argued that in chemical or pharmaceutical 
applications full protection requires applicant to claim a chemical 
substance, a composition containing the substance, method of making the 
substance, the chemical substance prepared by a claimed process and at 
least one method of use, where there is varying scope within each 
category of invention. The comments argued that individuals and small 
businesses would be unable to afford the costs of pursuing their 
inventions and may be discouraged from using the patent system due to 
the financial and procedural burdens they must overcome to obtain 
adequate patent protection of their invention. Several comments argued 
that the proposed rules would have a disproportionate impact on small 
entities. One comment stated that in the post-Festo environment, 
patent-drafting techniques would suggest filing a large number of 
picture claims in multiple statutory classes for easy understanding of 
the invention by the Federal Circuit. One comment stated that the 
primary reason why large numbers of claims are filed is that the 
applicants or their representatives do not want the effort and 
responsibility of determining the differences between the prior art and 
the invention, and that another reason is that attorneys who are paid a 
flat fee for applications attempt to induce a restriction requirement.
    Response: This final rule provides that if the number of 
independent claims is greater than five or the number of total claims 
is greater than twenty-five (a strategy based upon whether an 
application contains more than a given number of independent and total 
claims), the applicant must provide additional information to the 
Office in an examination support document under Sec.  1.265. The 
overall goal of these changes is to promote early presentation of 
claimed inventions, enhance quality and improve pendency. The rules do 
not impose a per se limit on the number of claims which can be 
presented to protect applicant's inventions. Rather, applicant may file 
any desired number and scope of claims necessary to adequately protect 
the applicant's invention as long as an examination support document is 
provided before the issuance of the first Office action on the merits 
of an application that present more than five independent claims or 
twenty-five total claims.
    The Office notes that, during fiscal year 2006, the percentage of 
small entity applications that exceeded the five independent claim and 
twenty-five total claim threshold appeared slightly higher than the 
percentage of total applications that exceeded the five independent 
claim and twenty-five total claim threshold (24.4 percent as opposed to 
23.7 percent). The Office does not consider this slight differential as 
establishing that the changes in this final rule have a 
disproportionate economic impact on small entities. While it is 
possible to engage in a mathematical exercise to exaggerate the 
significance of any slight differential, these percentages are based 
upon data that is available in the Office's PALM system for 
applications filed during the most recent fiscal year, and this slight 
differential is not sufficient to establish that the changes in this 
final rule have a disproportionate economic impact on small entities. 
In addition, there is no apparent reason why small entity applicants 
would inherently require more claims to adequately cover their 
inventions. Thus, even higher differences in these percentages could 
easily be explained by the fact that small entity applicants pay only 
one-half of the fees that other applicants pay for excess claims. 
Moreover, the five independent claim and twenty-five total claim 
threshold adopted in this final rule has a smaller differential than 
other alternatives suggested in the comments. For example, in fiscal 
year 2006: (1) 17.1 percent of small entity applicants exceeded a six 
independent claim and thirty total claim threshold where only 15.7 
percent of all applications exceeded a six independent claim and thirty 
total claim threshold; (2) 10.3 percent of small entity applicants 
exceeded a six independent claim and forty total claim threshold where 
only 9.2 percent of all applications exceeded a six independent claim 
and forty total claim threshold; and (3) 5.0 percent of small entity 
applicants exceeded a ten independent claim and fifty total claim 
threshold where only 4.1 percent of all applications exceeded a ten 
independent claim and fifty total claim threshold.
    The remaining explanations (post-Festo patent-drafting techniques, 
not wanting the responsibility of determining the differences between 
the prior art and the invention, and attempts to induce a restriction 
requirement) may be ``reasons'' why some applicants submit a large 
number of claims. These reasons, however, do not justify not going 
forward with a change to the rule of practice to require applicants who 
place an extensive burden on the Office to help focus examination by 
providing additional information in the form of an examination support 
document to the Office.
    Comment 167: One comment argued that choosing dependent claims to 
designate at the outset of prosecution forces applicant to make a 
threshold decision regarding claim scope without the benefit of 
analyzing cited prior art following an Office action. Thus, applicants 
either have to guess, or perform their own prior art search prior to 
filing, which puts a burden on applicant and results in the need to 
file a previously unnecessary information disclosure under Sec.  1.56.
    Response: The Office is not adopting the proposed ``representative 
claim'' approach. Therefore, no designation is required by this final 
rule. This final rule requires applicants who present more than five 
independent claims or more than twenty-five total claims to file an 
examination support document before the issuance of a first Office 
action on the merits of an application. Applicants are encouraged to 
conduct a preexamination search and review the references uncovered 
from the preexamination search so applicants can better understand 
where their invention fits in the overall patent landscape. Such action 
would facilitate presentation of claims more likely to be patentable 
over the closest prior art, thereby alleviating some of the burden on 
Office resources. Nevertheless, if applicant chooses not to conduct a 
preexamination search and does not submit an examination support 
document before the first Office action on the merits of the 
application, this does not constitute a justification for filing more 
than five independent claims or more than twenty-five total claims.

[[Page 46789]]

    Comment 168: One comment stated that it is unclear as to whether 
all claims, or only independent (or designated) claims, are counted for 
the purposes of Sec.  1.75(b)(4).
    Response: Pursuant to Sec.  1.75(b)(4) as adopted in this final 
rule, the Office will count all of the claims in copending applications 
containing patentably indistinct claims (including applications having 
a continuity relationship) but not in issued patents containing 
patentably indistinct claims, in determining whether each such 
application contains more than five independent claims or more than 
twenty-five total claims and thus whether an examination support 
document in compliance with Sec.  1.265 is required. Claims withdrawn 
from consideration under Sec. Sec.  1.141 through 1.146 or Sec.  1.499 
as drawn to a non-elected invention or inventions, however, will not, 
unless they are reinstated or rejoined, be taken into account in 
determining whether an application exceeds the five independent claim 
and twenty-five total claim threshold set forth in Sec. Sec.  
1.75(b)(1), (b)(3), and (b)(4). See Sec.  1.75(b)(5). As discussed 
previously, this final rule does not implement a ``representative 
claims'' examination approach.
    Comment 169: One comment stated that the rules do not provide 
speedy and economical administrative relief when the Office errs in 
determining whether claims are patentably indistinct, or whether there 
is adequate support in an application for a claim filed in another 
application.
    Response: As discussed previously, the Office already has timely 
and efficient procedures in place that provide for an applicant to seek 
relief with respect to matters subject to appeal (e.g., the rejection 
of claims) by way of an appeal to the BPAI under 35 U.S.C. 134 and 
Sec.  41.31 et seq., and to seek relief with respect to actions or 
requirements not subject to appeal by way of a petition to the Director 
under Sec.  1.181. For example, if a double patenting rejection is made 
because the claims of two applications are patentably indistinct, 
applicant may seek relief by way of an appeal to the BPAI. If the 
Office issues a notice under Sec.  1.75(b) requiring an examination 
support document in each of the multiple applications that contain 
patentably indistinct claims, applicant may seek relief by way of a 
petition to the Director under Sec.  1.181. A grant of relief in a 
petition, however, does not preclude a subsequent double patenting 
rejection.
    Comment 170: One comment argued that the rule will create more work 
for examiners by requiring review of all patents and applications 
assigned to one assignee of an application under examination, and that 
if certain examiners fail to do so, the rule will be unfairly applied 
within the Office. One comment argued that implementation of the rules 
will have a disproportionate effect on assignees holding small patent 
portfolios because due to time constraints, examiners will be able to 
review small patent portfolios more thoroughly than large ones.
    Response: The rules do not require examiners to review all patents 
and applications assigned to the same assignee, but rather require 
applicant to identify certain commonly assigned applications having a 
common inventor. See Sec.  1.78(f)(1). Examiners already face the 
situation of having to evaluate a potentially large number of commonly 
assigned patents and applications for the purpose of determining 
whether a prior art or double patenting rejection is warranted. The 
rules will enable the examiners to do this analysis more thoroughly and 
in less time, thus enhancing quality and reducing pendency.
    Comment 171: One comment argued that implementation of the rules 
will create an additional area of contention between examiners and 
applicants, and an additional drain on examiners' time. The comment 
further argued that the drain will be greater than that associated with 
double patenting because double patenting rejections can be overcome by 
filing terminal disclaimers.
    Response: No new issues between the examiner and the applicant are 
introduced by the changes being adopted in this final rule. Rather, the 
rules allow the examiner to identify and address issues more 
thoroughly. Furthermore, as a result of the rules, applicants will be 
made aware of issues earlier in the prosecution, thus giving applicants 
more time to formulate appropriate responses. Terminal disclaimers will 
continue to be available for use as appropriate to obviate non-
statutory double patenting rejections.
    Comment 172: One comment argued that the changes concerning claims 
are superfluous in view of the rule changes concerning continuation 
practice, and that a penalty for filing excessive continuations is 
already provided in the continuations rules.
    Response: The changes to the practice for examination of claims 
will operate in concert with the changes to the practice for continuing 
applications and requests for continued examination. The changes for 
the continued examination filing practice do not by themselves act to 
lessen the examiner's burden when faced with a large number of claims 
for examination.
    Comment 173: One comment questioned how the Office will implement 
review of two applications containing claims to the same invention.
    Response: If two or more commonly assigned applications contain 
patentably indistinct claims, the Office will track the applications 
via the PALM system. The applicant may explain why the claims of one 
application are patentably distinct from the claims of the other(s). If 
at least one claim is not patentably distinct and there are a total of 
more than five independent claims or more than twenty-five total claims 
in the applications, the applicant will be required to file an 
examination support document before the first Office action on the 
merits in each application. Applicant may file a terminal disclaimer to 
obviate an obviousness-type double patenting rejection.
    Comment 174: One comment suggested that the requirement that claims 
differ substantially according to Sec.  1.75(b) should only apply to 
independent claims.
    Response: The provision that ``[m]ore than one claim may be 
presented provided they differ substantially from each other and are 
not unduly multiplied'' has been set forth in Sec.  1.75(b) even prior 
to this final rule. The comment provides no reason why the requirement 
that claims differ substantially from each other and not be unduly 
multiplied should not also apply to dependent claims.
    Comment 175: One comment inquired about designation of claims 
during reexamination. The comment stated that the rules should not 
apply to reexaminations of patents granted prior to enactment of the 
rules.
    Response: The changes to Sec.  1.75 adopted in this final rule do 
not apply to reexamination proceedings. Furthermore, this final rule 
does not adopt the ``representative claims'' examination approach 
(which provided for a designation of dependent claims).
    Comment 176: A number of comments argued that the changes limit the 
protection paid for by applicant. One comment argued that as a result 
of the limitation on the number of claims, companies that invest in 
research and development could be expected to keep more inventions as 
trade secrets due to the threat posed by ``free riders'' who make minor 
modifications in an attempt to avoid infringement.
    Response: The patent statute requires that an applicant pay certain 
filing fees (the filing, search, examination, excess

[[Page 46790]]

claims, and application size fees) on filing an application for patent. 
See 35 U.S.C. 41(a). The payment of these patent filing fees does not 
amount to a purchase of patent protection but are simply to help cover 
the costs of examination and application processing.
    Section 1.75 does not limit the number of claims that applicant can 
present in an application. Section 1.75(b)(1) permits an applicant to 
present five independent claims and twenty-five total claims for 
examination without the need for an examination support document. An 
applicant who considers five independent claims or twenty-five total 
claims to be insufficient may present more than five independent claims 
or twenty-five total claims by submitting an examination support 
document under Sec.  1.265 before the first Office action on the merits 
of an application.
    Comment 177: One comment suggested that if the rules are 
implemented, the Office should reduce the examination fee and wait to 
charge the excess claim fees, or refund the excess claim fees if the 
application goes abandoned.
    Response: The basic filing, search, examination, and excess claims 
fees are set by statute, which the Office cannot change by rule making. 
The filing fees are due upon filing of the application and the excess 
claims fees are due when the claims are presented. See 35 U.S.C. 41. 
Applicant may request a refund of any previously paid search and excess 
claims fees if applicant expressly abandons an application filed under 
35 U.S.C. 111(a) on or after December 8, 2004, by filing a petition 
under Sec.  1.138(d) before an examination has been made of the 
application. An ``examination has been made of the application'' for 
purposes of Sec.  1.138(d) once there has been a requirement for 
restriction including an election of species, requirement for 
information under Sec.  1.105, first Office action on the merits, 
notice of allowability or allowance, or action under Ex parte Quayle. 
Applicant may also request a refund of any excess claims fees paid on 
or after December 8, 2004, if an amendment canceling the excess claims 
is filed before an examination on the merits has been made of the 
application. See Sec.  1.117. An ``examination on the merits has been 
made of the application'' for purposes of Sec.  1.117(a) once there has 
been a first Office action on the merits, notice of allowability or 
allowance, or action under Ex parte Quayle.
    Comment 178: One comment argued that the small number of 
problematic cases with excessive claims that confuse or obscure the 
invention can be adequately handled through the use of undue 
multiplicity rejections.
    Response: Undue multiplicity rejections based on 35 U.S.C. 112, ] 
2, are rare. See MPEP Sec.  2173.05(n). The rule changes are designed 
to provide a more focused quality examination of all applications. The 
Office would not be able to obtain the desired gains in efficiency and 
quality by merely relying on the use of undue multiplicity rejections.
    Comment 179: One comment argued that the impact of the rules on the 
backlog will be minimal and referred to the Inspector General Report of 
2004 which identified suboptimal incentives for examiners as the cause 
of the backlogs, not the excess number of claims.
    Response: The September 2004 Inspector General Report (Final 
Inspection Report No. IPE-15722), available at http://www.oig.doc.gov/oig/reports/2004/USPTO-IPE-15722-09-04.pdf, concluded that the Office 
should reevaluate patent examiner production goals, appraisal plans, 
and award systems. The September 2004 Inspector General Report was not 
the result of a general study of the causes of the growing backlog of 
unexamined patent applications, but was the result of a review of only 
patent examiner production goals, appraisal plans, and award systems. 
Thus, the September 2004 Inspector General Report does not discuss 
other causes of the growing backlog of unexamined patent applications 
(e.g., changes in applicant filing tendencies) and does not warrant the 
conclusion that the September 2004 Inspector General Report identifies 
suboptimal incentives for examiners as the sole cause of the growing 
backlog of unexamined patent applications. In any event, the Office is 
in the process of reassessing patent examiner production goals, 
appraisal plans, and award systems as recommended in the September 2004 
Inspector General Report. Absent significant changes to the patent 
examination process, the Office does not consider it reasonable to 
expect that changes to patent examiner production goals, appraisal 
plans, and award systems alone will be sufficient to address the 
growing backlog of unexamined patent applications while maintaining a 
sufficient level of quality.
    Comment 180: One comment argued that the Office admitted to 
previously abandoning a proposal to limit the number of total and 
independent claims. The comment argued that if such a proposal was 
deemed inappropriate, it is difficult to see how limiting claims before 
initial examination is also not inappropriate.
    Response: The previous proposal was not abandoned because it was 
deemed inappropriate; rather, it was abandoned because it was 
unpopular. The Office subsequently sought increases in excess claims 
fees via legislative change. There was insufficient public support for 
all the fee increases that the Office considered necessary and the 
current fees are not adequately addressing the problem of large numbers 
of claims. The comments submitted in response to the Claims Proposed 
Rule indicate that many view an approach similar to that proposed in 
1998 to be preferable. The changes being adopted in this final rule (in 
contrast to the changes proposed in 1998) do not place a limit on the 
number of claims (independent or dependent) that may be presented in an 
application. These changes adopted in this final rule simply require 
the submission of an examination support document if an applicant 
chooses to present more than five independent claims or more than 
twenty-five total claims in an application. Furthermore, the backlog of 
unexamined applications has increased from 224,446 at the end of fiscal 
year 1998 to 701,147 at the end of fiscal year 2006. The Office expects 
the backlog of unexamined applications to continue to increase without 
significant changes to the patent examination process. In addition, the 
average number of claims per application has not decreased since 1998. 
Thus, the Office does not consider the fact that the changes being 
adopted in this final rule may not be popular to be an adequate reason 
for not going forward at this time.
    Comment 181: One comment pointed out inconsistencies between 
proposed Sec.  1.75(b)(3)(iii), which requires a suggested restriction 
to be drawn to ``no more than ten'' claims, and the preamble to the 
proposed rule, which requires the restriction to be drawn to ``fewer 
than ten'' claims.
    Response: Proposed Sec.  1.75(b)(3)(iii) provided that an applicant 
may file a suggested requirement for restriction accompanied by an 
election without traverse of an invention to which there are drawn no 
more than ten independent claims and no more than ten representative 
claims. This final rule did not adopt the proposed ``representative 
claims'' examination approach, but requires applicant to file an 
examination support document when the application contains more than 
five independent claims or more than twenty-five total claims. Under 
Sec.  1.142(c) as adopted in this final rule, applicant may file a 
suggested

[[Page 46791]]

requirement for restriction accompanied by an election without traverse 
of an invention to which there are no more than five independent claims 
and no more than twenty-five total claims.
    Comment 182: One comment argued that applicants would circumvent 
the proposed rules by designating a ``picture claim'' in all 
applications, thereby forcing the examiner to perform a complete search 
and examination, thus obviating any time or effort saved through the 
proposed changes.
    Response: The Office has no objection to an applicant presenting a 
claim that recites in detail all of the features of an invention (i.e., 
a ``picture'' claim) in an application. Nevertheless, the mere fact 
that a claim recites in detail all of the features of an invention is 
never, in itself, justification for the allowance of such a claim. See 
MPEP Sec.  706.
    Comment 183: One comment argued that according to In re Wakefield, 
422 F.2d 897, 164 U.S.P.Q. 636 (C.C.P.A. 1970), applicant should be 
allowed to determine the necessary number and scope of claims.
    Response: The changes adopted in this final rule do not set a per 
se limit on the number of claims that an applicant may file in an 
application. The applicant is free to file as many claims as necessary 
to adequately protect the invention. Applicant may present more than 
five independent claims or more than twenty-five total claims in an 
application if applicant files an examination support document before 
the first Office action on the merits of the application. The 
information provided by the applicant in the examination support 
document will assist the examiner in understanding the claimed 
invention, determining the effective filing date of each claim and the 
claim interpretation before the prior art search, understanding the 
state of the art and the most closely related prior art cited by the 
applicant, and determining the patentability of the claims. Thus, the 
examiner will be able to perform a better examination on the claims.
    Comment 184: A number of comments argued that the rules would 
lessen the applicant's ability to file applications due to budget 
constraints and would increase costs for counseling applicants to get 
the best patent protection. One comment argued that the rules will 
increase applicant's costs to such an extent that individual inventors 
and small companies will not be able to afford patent protection. 
Furthermore, the costs to comply with the rules will cause many people 
with technology that can spur innovation to be frozen out of the patent 
process.
    Response: The current rules will only impact those applications 
that are filed with more than five independent claims or more than 
twenty-five total claims. If applicant presents more than five 
independent claims or more than twenty-five total claims, then 
applicant will be required to submit an examination support document 
under Sec.  1.265. If an application is so significant that the 
applicant must present more than five independent claims or more than 
twenty-five total claims, then the additional costs should not be a 
deterrent.
    Comment 185: One comment suggested that if the Office were to 
follow Muncie Gear Works v. Outboard Marine & Mfg Co., late claiming of 
applications would likely decrease.
    Response: In Westphal v. Fawzi, 666 F.2d 575, 577 (C.C.P.A. 1981), 
the Court of Customs and Patent Appeals discredited the idea that 
Muncie Gear Works v. Outboard Marine & Mfg. Co., 315 U.S. 759 (1942) 
should be read as announcing a new ``late claiming'' doctrine. Rather, 
the Court of Customs and Patent Appeals interpreted the Muncie Gear 
Works holding of invalidity as grounded in the statutory prohibition 
against new matter.
    Comment 186: A number of comments suggested that claims written in 
alternative form should not be treated differently from other claims, 
and that the Office should use election of species practice to identify 
alternatives to be used as representative claims. Several comments 
stated that claims drafted using Markush or other alternative language 
should be treated as single claims rather than treating each 
alternative as a separate claim. One comment stated that if members of 
Markush groups are counted separately, biotechnology and chemical 
applicants will file more multiple parallel applications. One comment 
requested clarification as to whether each element of a Markush claim 
would be considered to be an independent claim. One comment stated that 
Markush claims are beneficial to both the Office and applicants, and 
stated that the proposed changes would unfairly disadvantage members of 
the pharmaceutical community. One comment suggested that encouraging 
applicants to adhere more closely to existing 35 U.S.C. 112, ] 1 and 35 
U.S.C. 101 requirements is a better means of managing the breadth of 
Markush claims than individualized claim counting schemes and required 
showings. One comment suggested that the Office should treat a Markush 
claim as a broad or generic claim. One comment asserted that the Office 
has not provided any study or anecdotal evidence that identifies an 
abuse of Markush practice. One comment stated that the MPEP has never 
required that individual elements in a Markush group be treated 
separately, and that it is unfair to an applicant to use up claim 
designations on the individual elements of a Markush group because a 
reference teaching one element is applied to all.
    Several comments argued that the proposed rule relating to 
determining the presence of separate claims in a Markush grouping will 
slow down prosecution, in part due to an increased number of petitions 
to review.
    Response: The Office requested comments on how claims written in 
the alternative form, such as claims in an alternative form permitted 
by Ex parte Markush, 1925 Dec. Comm'r Pat. 126 (1924), should be 
counted for purposes of proposed Sec.  1.75(b). See Changes to Practice 
for the Examination of Claims in Patent Applications, 71 FR at 64, 1302 
Off. Gaz. Pat. Office at 1331. This final rule does not change the 
practice of the Office with regard to claims containing Markush or 
other alternative language. That is, a claim containing Markush or 
other alternative language would be considered as one claim for the 
purposes of determining whether an application exceeds the five 
independent claim and twenty-five total claim threshold set forth in 
Sec.  1.75(b). However, the Office is evaluating changes to Markush 
practice, which could be implemented in a separate rule making.
    The Office is also clarifying second action final practice with 
respect to using alternative language (e.g., Markush claims). MPEP 
Sec.  803.02 indicates that if an applicant amends a rejected Markush 
claim to exclude species anticipated or rendered obvious by the prior 
art, a second action on the rejected claims can be made final unless 
the examiner introduces a new ground of rejection that is neither 
necessitated by applicant's amendment of the claims nor based on 
information submitted in an information disclosure statement filed 
under Sec.  1.97(c) with the fee set forth in Sec.  1.17(p). MPEP Sec.  
803.02 provides this instruction in the context of the situation in 
which the examiner has determined that the Markush claim encompasses at 
least two independent or distinct inventions, has required applicant to 
make a provisional election of a single species, and has rejected the 
Markush claim on prior art grounds. This has led to some confusion as 
to when a second action on the rejected claims can be made final when 
the examiner has not found that the claim encompasses at least two 
independent

[[Page 46792]]

or distinct inventions and applicant amends a claim to exclude 
unpatentable alternatives. If a Markush claim or other claim that sets 
forth alternatives is rejected under 35 U.S.C. 102 or 103 on the basis 
of prior art that anticipates or renders obvious the claim with respect 
to any one of the alternatives or on any other basis (e.g., 35 U.S.C. 
101 or 112) with respect to any one of the alternatives, a second or 
any subsequent Office action on the merits may be made final. However, 
such an Office action may not be made final if it contains a new ground 
of rejection that is not: (1) Necessitated by applicant's amendment of 
the claims (including amendment of a claim to eliminate unpatentable 
alternatives); (2) necessitated by applicant's providing a showing that 
a claim element that does not use the phrase ``means for'' or ``step 
for'' is written as a function to be performed and does not otherwise 
preclude application of 35 U.S.C. 112, ] 6; (3) based on information 
submitted in an information disclosure statement filed during the 
period set forth in Sec.  1.97(c) with the fee set forth in Sec.  
1.17(p); or (4) based upon double patenting (statutory or obviousness-
type double patenting). The provision in MPEP Sec.  904.02 that a 
search should cover the claimed subject matter and should also cover 
the disclosed features which might reasonably be expected to be claimed 
does not preclude an examiner from making the second or any subsequent 
Office action on the merits final if the Office action contains a new 
ground of rejection that was necessitated solely by applicant's 
amendment of the claims to eliminate the unpatentable species.
    Comment 187: A number of comments supported the appropriate use of 
the proposed requirement in Sec.  1.105(a)(1)(ix) where this 
information is needed to resolve a reasonable question which is 
relevant to the determination of a patentability issue before the 
examiner.
    Response: The Office is adopting the change to Sec.  1.105.
    Comment 188: One comment argued that the provision in Sec.  
1.105(a)(1)(ix) serves no purpose and may be abused. The comment argued 
that examiners could simply shift the burden on applicant to prove 
support when there is no basis for making a rejection under 35 U.S.C. 
112, ] 1. One comment argued that the changes to Sec.  1.105(a)(1)(ix) 
are unnecessary since examiners already have the power to request such 
information.
    Response: One purpose of the provision in Sec.  1.105(a)(1)(ix) is 
to assist the examiner in properly examining the application when it is 
not readily apparent where the specification of the application 
provides support under 35 U.S.C. 112, ] 1, for a claim or a limitation 
of a claim. This is information that the applicant should be aware of 
and should be able to provide to the examiner. The Office considers 
this authority to be inherent under the patent statute and rules 
existing prior to this rule change, including the previous version of 
Sec.  1.105, and thus there is no reason to expect such provision to be 
abused. The Office agrees that examiners inherently have the authority 
to request this information. See Star Fruits S.N.C. v. United States, 
393 F.3d 1277, 73 USPQ2d 1409 (Fed. Cir. 2005). The Office is amending 
Sec.  1.105 to make the authority explicit.
    Comment 189: One comment suggested that the Office should encourage 
examiners to use Sec.  1.105 to require a concise, plain-English 
explanation of the invention and claim set when the application 
contains large claim sets or the invention cannot be understood.
    Response: The examination support document will assist the examiner 
when there are large numbers of claims. If the invention cannot be 
understood, the examiner could use Sec.  1.105 to require an 
explanation.
    Comment 190: Several comments suggested that language should be 
added to the rules to indicate that the information required by Sec.  
1.105(a)(1)(ix) is not to be used to read limitations into the claims.
    Response: Such a change is not necessary. It is well established 
that the meaning of the terms in the claims is to be ascertained in 
light of the specification but that limitations from the specification 
are not to be read into the claims. See Phillips v. AWH Corp., 415 F.3d 
1301, 1316, 75 U.S.P.Q.2d 1321, 1329 (Fed. Cir. 2005); In re American 
Academy of Science Tech Center, 365 F.3d 1359, 1369, 70 USPQ2d 1827, 
1834 (Fed. Cir. 2004); In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 
1322 (Fed. Cir. 1989).
    Comment 191: A number of comments supported the extension of the 
Office's refund authority beyond the expiration date of the legislation 
and encouraged the Office to accelerate implementation of Sec.  1.117.
    Response: The Office is working to make the patent fee and fee 
structure provisions of the Consolidated Appropriations Act, 2005 (Pub. 
L. 108-447, 118 Stat. 2809 (2004)), permanent. The Revised Continuing 
Appropriations Resolution, 2007 (Pub. L. 110-5, 121 Stat. 8 (2007)), 
keeps the patent fee and fee structure provisions of the Consolidated 
Appropriations Act, 2005, in effect during fiscal year 2007. The Office 
is implementing Sec.  1.117 in this final rule.
    Comment 192: Several comments questioned whether excess claim fees 
would be refunded if claims are eliminated pursuant to Sec.  
1.78(f)(3).
    Response: Applicant may request a refund of any excess claims fees 
paid on or after December 8, 2004, if an amendment canceling the excess 
claims is filed before an examination on the merits has been made of 
the application. See Sec.  1.117. Applicant may also request a refund 
of any previously paid search and excess claims fees if applicant 
expressly abandons an application filed under 35 U.S.C. 111(a) on or 
after December 8, 2004, by filing a petition under Sec.  1.138(d) 
before an examination has been made of the application.
    Comment 193: One comment suggested that the Office should refund 
eighty percent of the fees for claims that are withdrawn because of a 
restriction requirement.
    Response: The Office does not have the statutory authority to 
refund the excess claims fees for claims that are still pending in an 
application where the fees were properly paid. The Consolidated 
Appropriations Act, 2005, authorizes a refund only for a claim that has 
been canceled before an examination on the merits has been made of the 
application under 35 U.S.C. 131. See 35 U.S.C. 41(a)(2)(C). Claims that 
are withdrawn due to a restriction requirement are still pending in the 
application. Applicant may cancel the withdrawn claims prior to a first 
Office action on the merits of the application and request for a refund 
of any excess claims fees paid on or after December 8, 2004. See Sec.  
1.117.
    Comment 194: A number of comments noted that since very few 
examination support documents are likely to be filed, there is not 
likely to be any opportunity to reduce a patent term adjustment.
    Response: The Office is not adopting the changes in this final rule 
for the purpose of reducing patent term adjustment. The Office simply 
does not want an applicant to obtain patent term adjustment by delaying 
compliance with the examination support document requirements.
    Comment 195: Several comments argued that it was unfair to reduce 
patent term adjustment for not complying with the rules for 
applications pending before the effective date.
    Response: Section 1.704(c)(11) as adopted in this final rule is 
applicable only to applications under 35 U.S.C. 111(a) filed on or 
after November 1,

[[Page 46793]]

2007, or international applications that have commenced the national 
stage after compliance with 35 U.S.C. 371 on or after November 1, 2007. 
Thus, other applications for which an examination support document (or 
other appropriate action) is required would not encounter a patent term 
adjustment reduction unless the applicant failed to properly reply to 
an Office notice requiring an examination support document (or other 
appropriate action) within three months of the date the notice was 
mailed to the applicant.
    Comment 196: One comment argued that Sec.  1.704(c)(11) is contrary 
to statute because 35 U.S.C. 154(b)(2)(C)(ii) guarantees a minimum of 
three months to respond before patent term adjustment is lost.
    Response: 35 U.S.C. 154(b)(2)(C)(ii) provides that ``[w]ith respect 
to adjustments to patent term made under the authority of [35 U.S.C. 
154(b)(1)(B)], an applicant shall be deemed to have failed to engage in 
reasonable efforts to conclude processing or examination of an 
application for the cumulative total of any periods of time in excess 
of 3 months that are taken to respond to a notice from the Office 
making any rejection, objection, argument, or other request, measuring 
such 3-month period from the date the notice was given or mailed to the 
applicant.'' See 35 U.S.C. 154(b)(2)(C)(ii). The patent term adjustment 
reduction provision of 35 U.S.C. 154(b)(2)(C)(ii) is applicable where 
the applicant's failure to engage in reasonable efforts to conclude 
processing or examination of an application involves a failure to reply 
to an Office action or notice within three months of the date the 
Office action or notice is mailed or given to the applicant. 35 U.S.C. 
154(b)(2)(C), however, contemplates other circumstances that may 
constitute an applicant's failure to engage in reasonable efforts to 
conclude processing or examination, by further providing that ``[t]he 
Director shall prescribe regulations establishing the circumstances 
that constitute a failure of an applicant to engage in reasonable 
efforts to conclude processing or examination of an application.'' See 
35 U.S.C. 154(b)(2)(C)(iii). The provisions of Sec.  1.704(c), 
including Sec.  1.704(c)(11), are promulgated under the Office's 
authority in 35 U.S.C. 154(b)(2)(C)(iii) to prescribe regulations 
establishing the circumstances that constitute a failure of an 
applicant to engage in reasonable efforts to conclude processing or 
examination of an application. For example, an examination support 
document is required to be filed before the issuance of a first Office 
action on the merits when the application contains or is amended to 
contain more than five independent claims or more than twenty-five 
total claims. See Sec.  1.75(b)(1). Therefore, Sec.  1.704(c) provides 
for a reduction of any patent term adjustment when there is a failure 
to comply with Sec.  1.75(b), e.g., a failure to file an examination 
support document in compliance with Sec.  1.265 when necessary under 
Sec.  1.75(b). The Office does not issue a notice requiring an 
examination support document (or other appropriate action) until the 
Office has determined that an examination support document is required 
under Sec.  1.75(b), but applicant failed to submit an examination 
support document.
    Comment 197: Several comments argued that Sec.  1.704(c)(11) would 
adversely affect small businesses. One comment argued that some patents 
owned by universities and small biotechnology companies have values of 
one million dollars per day, and these patents often have hundreds of 
days of patent term extension. The comment argued that the proposed 
reductions in patent term would easily cost small businesses one 
hundred million dollars per year.
    Response: An applicant can avoid a reduction in patent term 
adjustment simply by providing an examination support document in 
compliance with Sec.  1.265 before the first Office action on the 
merits or taking other appropriate action (if necessary) in a timely 
manner.
    Comment 198: One comment questioned whether the proposed changes to 
Sec.  1.75 (the ``representative claims'' examination approach) as 
applied to national stage applications violate the PCT. Another comment 
suggested that the proposed changes to Sec.  1.75 are contrary to PCT 
Article 17.
    Response: As discussed previously, this final rule does not 
implement a ``representative claims'' examination approach. 
Nevertheless, nothing in the PCT or the regulations under the PCT 
requires a designated Office to examine all claims presented (in any 
particular order or at a particular stage) in a national stage 
application. Furthermore, PCT Article 27(6) provides that the national 
law may require that the applicant furnish evidence in respect of any 
substantive condition of patentability prescribed by such law. Under 
this final rule, applicant is free to submit as many claims as he or 
she chooses, as long as applicant files an examination support document 
before the first Office action on the merits if there are more than 
five independent claims or more than twenty-five total claims. Article 
17 of the PCT concerns procedures before the international searching 
authorities. The changes to Sec.  1.75 do not apply to international 
searching authorities and, accordingly, do not conflict with Article 
17.

G. Number of Independent and Total Claims Permitted Without an 
Examination Support Document

    Comment 199: A number of comments argued that the proposed change 
in the definition of an independent claim for determining the number of 
designated claims and calculating additional claims fees would be 
complicated and confusing. A number of comments argued that the 
statutory classes of invention are not necessarily mutually exclusive. 
A number of comments expressed the opinion that the proposed changes to 
the way claims are treated for fee purposes will further burden the 
Office. One comment stated that it would cause disputes and slow down 
the examination process. One comment argued that it would likely 
produce inconsistent results. One comment argued that the rule change 
makes it very difficult to calculate claim fees for anyone other than a 
registered practitioner. Several comments opined that as a result of 
the proposed rule, the fee calculation process would no longer be 
merely administrative, but would involve a legal opinion. The comments 
questioned whether fee calculations will be handled by examiners, and 
what the process for dispute resolution will be. A number of the 
comments also argued that the change would effectively increase fees.
    Response: Designation of claims for initial examination is not 
required because this final rule did not adopt the ``representative 
claims'' examination approach. This final rule, however, requires 
applicant to file an examination support document in compliance with 
Sec.  1.265 before the issuance of a first Office action on the merits 
of an application that contains more than five independent claims or 
twenty-five total claims, counting all of the claims in any other 
copending application having a patentably indistinct claim. If an 
examination support document in compliance with Sec.  1.265 is not 
filed before the issuance of a first Office action on the merits of the 
application, the application may not contain or be amended to contain 
more than five independent claims or more than twenty-five total 
claims.
    This final rule adopts the proposed changes to Sec.  1.75(b)(2) to 
provide that a claim that refers to a claim of a different statutory 
class of invention will also be treated as an independent claim for fee

[[Page 46794]]

calculation purposes and for purposes of determining whether an 
application exceeds the five independent claim and twenty-five total 
claim threshold under Sec.  1.75(b). Section 1.75(b) (introductory 
text) as adopted in this final rule clarifies that a dependent claim 
must contain a reference to a claim previously set forth in the same 
application, incorporate by reference all the limitations of the 
previous claim to which such dependent claim refers, and specify a 
further limitation of the subject matter of the previous claim. See 35 
U.S.C. 112, ] 4; see also Pfizer, 457 F.3d at 1291-1292, 79 U.S.P.Q.2d 
at 1589-1590. If a claim does not incorporate by reference all the 
limitations of the previous claim to which it refers, it is not a 
dependent claim under 35 U.S.C. 112, ] 4. It would be proper for the 
Office to consider such a claim as an independent claim for fee 
calculation purposes and for purposes of determining whether an 
examination support document is required. The determination of whether 
a claim is independent or dependent could be difficult when applicant 
did not clearly draft the claim as an independent claim or a dependent 
claim under 35 U.S.C. 112, ] 4. Applicant may minimize issues related 
to fee calculation for claims by drafting claims that are in compliance 
with 35 U.S.C. 112, ] 4, and Sec.  1.75(b) (e.g., not presenting claims 
that refer to another claim of a different statutory class of invention 
or claims that refer to another previous claim but do not incorporate 
by reference all of the limitations of the previous claim). Once a 
determination of whether a claim is independent or dependent has been 
made, the fee calculation is simple. If applicant disagrees with the 
Office's determination that a claim is an independent claim, applicant 
should provide a showing of how the claim is a dependent claim in 
compliance with 35 U.S.C. 112, ] 4, and Sec.  1.75(b) either in a reply 
to a notice requiring a claim fee or a request for a refund.
    Comment 200: One comment stated that a claim that does not make 
reference to another claim is an independent claim, and a claim that 
does make reference to another claim is a dependent claim. One comment 
stated that the Office cannot charge independent claim fees for 
dependent claims because to do so would violate statute. One comment 
questioned how a claim can fail to incorporate by reference all of the 
limitations of the claim to which it refers, and yet be statutory. The 
comment suggested that the proposed rule is unnecessary and not 
supported by the case law cited by the Office. One comment suggested 
that the changes to Sec.  1.75(b)(2) (e.g., treating a claim that 
refers to a claim of a different statutory class of invention as an 
independent claim for fee calculation purposes and for purposes of 
determining whether an examination support document is required) might 
be contrary to judicial precedent set forth in In re Ochiai, 71 F.3d 
1565, 37 U.S.P.Q.2d 1127 (Fed. Cir. 1995). The comment also argued that 
these changes would create a ``tricky fee structure'' and a ``trap for 
the unwary'' and would increase the administrative/non-substantive 
workload on the examiner.
    Response: A claim that merely refers to another claim is not a 
dependent claim in compliance with 35 U.S.C. 112, ] 4. A proper 
dependent claim must also incorporate by reference all the limitations 
of the claim to which it refers and specify a further limitation of the 
subject matter in the claim to which the dependent claim refers. Some 
applicants present claims that refer to a previous claim, but fail to 
comply with the requirements of 35 U.S.C. 112, ] 4. See e.g., Pfizer, 
457 F.3d at 1291-1292, 79 U.S.P.Q. 2d at 1589-1590. The provisions of 
Sec.  1.75(b)(2) are consistent with 35 U.S.C. 112, ] 4, and judicial 
precedent including Ochiai (the use of per se rules in determining 
nonobviousness under 35 U.S.C. 103). A claim that refers to a previous 
claim of a different statutory class of invention could require a 
separate search and patentability determination because the 
patentability of such a claim might not stand or fall together with the 
previous claim. For example, if claim 1 recites a specific product, a 
claim for method of making the product of claim 1 in a particular 
manner would require a separate patentability determination because in 
accordance with Ochiai, there is no per se rule in applying the test 
for obviousness under 35 U.S.C. 103. Furthermore, a claim that refers 
to a previous claim of a different statutory class of invention does 
not comply with 35 U.S.C. 112, ] 4, because such a claim does not 
further limit the subject matter of the previous claim.
    Comment 201: A number of comments recommended that the Office issue 
guidance for use by Office employees as well as the public in 
distinguishing among statutory classes of invention. One comment stated 
that it is unclear how ``a different statutory class of invention'' 
will be applied. The comment questioned whether the last sentence of 
Sec.  1.75(b)(2) would apply only to combination method-apparatus 
claims or whether it might also be applied to regular dependent claims 
which add additional limitations of a similar kind such as a method 
limitation for a method claim or an apparatus limitation for an 
apparatus claim. One comment stated that Sec.  1.75(b)(2) provides 
clarification that claims which refer to a claim of a different 
statutory class would be regarded as independent. One comment stated 
that Sec.  1.75(b)(2) appears to be a statement of the current state of 
the law.
    Response: The statutory classes of invention are set forth in 35 
U.S.C. 101. If a method claim depends from another method claim, 
incorporates by reference all of the limitations of the method claim 
from which it depends, and adds additional method limitations, such a 
claim will be considered as a dependent claim. However, if a method 
claim refers to a composition claim (e.g., ``A method of using the 
composition of claim 1 comprising * * *''), it will be treated as an 
independent claim. The Office will issue any guidance as necessary and 
appropriate for the implementation of the rules.
    Comment 202: Several comments argued that Sec.  1.75(b) is a 
problem for software-based inventions because it is common for 
applications to include claims to different classes of invention. The 
comments argued that there is no reason to discourage a claim drawn to 
one class of invention which depends from a claim drawn to another 
class when little additional work is required of the examiner to 
examine both claims, citing the example of a claim drawn to a 
manufacture which depends from a claim drawn to a process for making a 
manufacture.
    Response: The rule does not discourage an applicant from submitting 
whatever claims may be considered desirable for protection of the 
invention, and does not discourage submission of claims to any 
statutory class of invention. Rather, the rule clarifies how claims 
will be treated for the purposes of fee calculation and determination 
whether an examination support document is required under Sec.  
1.75(b)(1).
    Comment 203: A number of comments argued that ten representative 
claims are not sufficient for adequate patent protection and suggested 
various numbers for the representative claim limit including at least 
twenty claims, twenty-five claims, or at least thirty claims. Several 
comments suggested twenty claims, with a maximum of three independent 
claims, as being more consistent with the fee schedule. Several 
comments suggested that the limit should be six independent and forty 
total claims. One comment suggested that the limit should be twelve 
independent claims and fifty total claims. One comment suggested

[[Page 46795]]

that the limit should be ten independent claims and sixty total claims. 
Several comments suggested that there should be no limit. One comment 
suggested that there should be no limit on dependent claims.
    Several comments stated that the rules affect the vast majority of 
applications that contain an ordinary number of claims, rather than 
targeting the small number of problem applications with excessive 
claims. One comment stated that it was unclear why all applicants 
should be limited to representative claims when approximately ninety 
percent of all non-provisional applications currently filed contain six 
or fewer independent claims and forty or fewer total claims. The 
comment argued that examining forty or fewer claims does not appear to 
constitute an undue examination burden. One comment suggested that the 
rule changes should be more narrowly tailored with respect to the 
technology areas where the inventions are not capable of being 
adequately protected using only twenty claims. One comment inquired 
about the need for establishing a separate procedure for examination of 
claims if only 1.2 percent of applications fall within the category of 
excess claims. Several comments argued that there is a lack of 
statistical analysis relating to the number of applications containing 
more than ten total claims.
    Response: The Office notes the concerns expressed in the public 
comments concerning the proposed ``representative claims'' examination 
approach. The Office did not adopt this approach in this final rule. 
This final rule provides that if the number of independent claims is 
greater than five or the number of total claims is greater than twenty-
five, the applicant must provide additional information to the Office 
in an examination support document under Sec.  1.265 covering all of 
the claims in the application (whether in independent or dependent 
form).
    The Office received a significant number of comments suggesting a 
threshold of six independent claims and thirty total claims. The Office 
also received a number of comments suggesting independent claim 
thresholds ranging from three to ten and total claim thresholds ranging 
from twenty to sixty (or no limit). The comments, however, provided no 
justification for deeming any particular independent and total claim 
threshold to be the ideal threshold or even superior to any other 
possible independent and total claim threshold. The Office arrived at 
the five independent claim and twenty-five total claim threshold 
primarily for the following reasons.
    First, a significant number of comments suggested a threshold of 
six independent claims and thirty total claims, but did not suggest 
such a threshold if it were not considered sufficient to provide 
adequate patent protection for an invention.
    Second, the majority of applications contain no more than five 
independent claims and no more than twenty-five total claims. 
Specifically, over 92 percent of the applications filed in fiscal year 
2006 contained no more than five independent claims, and over 78 
percent of the applications filed in fiscal year 2006 contained no more 
than twenty-five total claims. These figures do not take into account 
that many applications contained claims to more than one distinct 
invention, and the changes in this final rule permit an applicant to 
suggest a restriction requirement and elect an invention to which there 
are drawn no more than five independent and twenty-five total claims. 
In addition, the majority of applications in every Technology Center 
contain five or fewer independent claims and twenty-five or fewer total 
claims. Therefore, there is no support for the position that there are 
technology areas that are just not capable of being adequately 
protected with five or fewer independent claims and twenty-five or 
fewer total claims. Finally, the Office notes that the most common 
number of independent claims presented in an application is three, and 
the most common number of total claims presented in an application is 
twenty.
    Third, an applicant may present up to fifteen independent claims 
and seventy-five total claims via an initial application and two 
continuation or continuation-in-part applications that are prosecuted 
serially without providing either an examination support document or a 
justification as discussed previously. Only about five percent of the 
applications filed in fiscal year 2006 were in an application family 
that contained more than fifteen independent claims or more than 
seventy-five total claims.
    Finally, this final rule does not preclude an applicant from 
presenting more than five independent claims or more than twenty-five 
total claims. Rather, an applicant may present more than five 
independent claims or more than twenty-five total claims in an 
application with an examination support document in compliance with 
Sec.  1.265 if the applicant considers it necessary or desirable in the 
particular application. Specifically, this final rule requires 
applicant to file an examination support document in compliance with 
Sec.  1.265 before the issuance of a first Office action on the merits 
of an application that contains more than five independent claims or 
twenty-five total claims, counting all of the claims in any other 
copending application having a patentably indistinct claim. If an 
examination support document in compliance with Sec.  1.265 is not 
filed before the issuance of a first Office action on the merits of the 
application, the application may not contain or be amended to contain 
more than five independent claims or more than twenty-five total 
claims.
    Comment 204: A number of comments suggested that the Office should 
explore the possibility of examining multiple dependent claims that are 
dependent on other multiple dependent claims to reduce examination 
burden and better focus the examination process. The comments argued 
that most foreign countries permit such claims and that this would 
significantly reduce the number of claims. One comment argued that if 
the Office adopts representative claims rules, it will move towards the 
European style of claim sets, but without the benefit of multiple 
dependent claims and claims stated in the alternative. Several comments 
expressed the opinion that multiple dependent claims should be 
encouraged because examining a multiple dependent claim is no more work 
than examining a single dependent claim.
    Response: As discussed previously, the Office did not adopt the 
``representative claims'' examination approach in this final rule. 
Further, 35 U.S.C. 112, ] 5, prohibits multiple dependent claims that 
are dependent on other multiple dependent claims. Moreover, the 
examination of multiple dependent claims that are dependent on other 
multiple dependent claims would be at least as burdensome as if these 
claims were presented as a plurality of single dependent claims or as 
permitted multiple dependent claims. The Office disagrees that 
permitting multiple dependent claims that depend on other multiple 
dependent claims would reduce the examination burden or better focus 
the examination process. The Office's experience is that multiple 
dependent claims are significantly more difficult to search and 
evaluate than a plurality of single dependent claims. Multiple 
dependent claims that depend on other multiple dependent claims would 
be even more burdensome. While the use of multiple dependent claims may 
be a convenient shorthand mechanism, a multiple dependent claim

[[Page 46796]]

is considered to be that number of claims to which direct reference is 
made therein and must be considered in the same manner as a plurality 
of single dependent claims. See MPEP Sec.  608.01(n), paragraph I. The 
same would be true for multiple dependent claims that are dependent on 
other multiple dependent claims.
    Comment 205: One comment suggested that there should be a limit of 
twenty claims in every application with no exceptions and no 
requirement for an examination support document. Another comment 
suggested that the Office should limit the number of claims of any 
application to twenty or thirty total claims, and two or three 
independent claims. One comment suggested that there should simply be a 
hard cap without an option to file an examination support document to 
have additional claims examined. The comment argued that this would not 
take away any substantive rights, as long as applicant's right to file 
continuing applications and requests for continued examination is 
preserved.
    Response: This final rule appropriately balances applicants' 
interests to have an adequate number of claims to protect their 
inventions and the need to reduce the large and growing backlog of 
unexamined patent applications, improve the quality of issued patents, 
and make the patent examination process more effective. The changes to 
Sec.  1.75 in this final rule permit an applicant to present five or 
fewer independent claims and twenty-five or fewer total claims in the 
application without submitting an examination support document in 
compliance with Sec.  1.265. The changes to Sec.  1.75 in this final 
rule also permit an applicant to present more than five independent 
claims or more than twenty-five total claims if the applicant files an 
examination support document in compliance with Sec.  1.265.
    Comment 206: Several comments suggested that the Office should 
adjust the fees if excess claims fees are insufficient to permit 
examination of the claims for which they are paid. One comment 
suggested that there should be higher fees for claims in excess of ten. 
Several comments suggested that there should be higher fees for claims 
in excess of twenty. One comment suggested higher fees for independent 
claims in excess of three. One comment suggested that there should be a 
higher fee for independent claims in excess of ten and total claims in 
excess of fifty. Several comments suggested that there should be 
escalating fees for increasing numbers of claims. One comment argued 
that applicants should be permitted to designate a number of claims, 
without an examination support document, that varies with the filing 
fee paid. One comment suggested that applicants should be charged in 
proportion to the number of designated claims, and that, optionally, an 
upper bound on the number of claims (e.g., twenty-five total claims, no 
more than twelve independent claims) could be established.
    Response: Excess claims fees are set by statute. See 35 U.S.C. 
41(a). The Office sought a legislative change to increase excess claims 
fees, and while some increases were made in the Consolidated 
Appropriations Act, 2005, the Office did not obtain the increases that 
it considered necessary. In any event, the changes adopted in this 
final rule will help to focus examination and increase quality.
    Comment 207: Several comments suggested that excessive claiming 
should be dealt with on a case-by-case basis, rather than by penalizing 
all applicants. One comment suggested that the Office should consider 
strategies under present Sec.  1.105 to address problem applications on 
a case-by-case basis. A number of comments suggested that the 
requirement for an examination support document should be imposed on a 
case-by-case basis, only in those situations that impose a unique 
burden on the Office.
    Response: As discussed previously, the Office is not adopting the 
``representative claims'' examination approach under which the majority 
of applicants would have been required to either designate dependent 
claims for initial examination or file an examination support document. 
The changes adopted in this final rule require the applicant to file an 
examination support document under Sec.  1.265 only if the applicant 
presents more than five independent claims or more than twenty-five 
total claims. If an examination support document in compliance with 
Sec.  1.265 is not filed before the issuance of a first Office action 
on the merits of the application, the application may not contain or be 
amended to contain more than five independent claims or more than 
twenty-five total claims. The majority of applications do not contain 
more than five independent claims or more than twenty-five total 
claims. Therefore, as a result of the public comment, this final rule 
adopts an approach that avoids requiring a majority of applicants to 
make the choice between designating dependent claims for initial 
examination and filing an examination support document.
    Comment 208: One comment suggested that one of the representative 
claims should be in Jepson format. Another comment suggested that fees 
should be increased on all non-Jepson claims. One comment suggested 
that the Office should charge less for claims written in Jepson format.
    Response: There is no persuasive explanation as to why Jepson 
claims should be treated differently from non-Jepson claims. 
Furthermore, fees are set by statute and the statute does not provide 
the authority to charge higher or lower fees for Jepson claims.
    Comment 209: One comment suggested that there should be an 
expedited procedure for an application with a limit of five claims, a 
1200-word specification, and four drawings, (with the filing fee being 
$1000 for a small entity or $3000 for a non-small entity), where the 
application could issue as a patent in fifteen months or less. One 
comment argued that the representative claim proposal should be an 
option for applicants and those applications with ten or fewer 
representative claims should be assigned a higher priority for 
examination. One comment argued that the examination support document 
should only be used as an optional procedure for an applicant to 
advance the application out of turn.
    Response: The proposed ``representative claims'' examination 
approach is not adopted in this final rule. Further, the Office has 
revised its accelerated examination program with the goal of completing 
examination within twelve months of the filing date of the application. 
The application must contain three or fewer independent claims and 
twenty or fewer total claims, and the applicant must provide an 
accelerated examination support document and meet a number of other 
requirements. See Changes to Practice for Petitions in Patent 
Applications To Make Special and for Accelerated Examination, 71 FR 
36323 (June 26, 2006), 1308 Off. Gaz. Pat. Office 106 (July 18, 2006) 
(notice). However, requiring an examination support or similar document 
only as an optional procedure for applicant to advance the application 
out of turn would not result in the desired gains in efficiency and 
quality.
    Comment 210: One comment suggested that if examination is limited 
to a certain number of claims, the Office should not be allowed to make 
a restriction requirement that is not linked to the burden of 
searching. Thus, the comment suggested that where different statutory 
classes or independent claims within a class do not really impose an 
additional burden,

[[Page 46797]]

they should not be counted against the examination limit.
    Response: Under the current restriction practice, the burden of the 
search and examination in an application is considered before a 
requirement for restriction is made. See MPEP section 803. This 
includes where there are different statutory classes of invention or 
independent claims within a class that do not impose a search burden.
    Comment 211: A number of comments argued that the one-month time 
period to reply to a notification of more than ten representative 
claims was too short to prepare and submit an adequate examination 
support document. One comment suggested that the time period should be 
at least two months with extensions of time being permitted. One 
comment suggested that the time period should be three months with 
extensions of time being permitted.
    Response: The proposed ``representative claims'' examination 
approach is not adopted in this final rule. Under this final rule, 
applicant is required to provide an examination support document if 
applicant presents more than five independent claims or more than 
twenty-five total claims in an application. If an examination support 
document in compliance with Sec.  1.265 is not filed before the 
issuance of a first Office action on the merits of the application, the 
application may not contain or be amended to contain more than five 
independent claims or more than twenty-five total claims. The time 
period provided in the notice requiring an examination support document 
is only applicable where it appears that the omission of an examination 
support document was inadvertent. Therefore, applicant should prepare 
and file an examination support document when applicant presents more 
than five independent claims or more than twenty-five total claims in 
an application. Applicant should not rely on the notification from the 
Office and a new period within which to prepare an examination support 
document. Nevertheless, the Office is revising this provision to 
provide a two-month time period that is not extendable under Sec.  
1.136(a), which should be sufficient for those situations in which an 
applicant inadvertently omitted an examination support document.
    Comment 212: A number of comments argued that the notice to the 
applicant under Sec.  1.75(b)(3) would impose costs because it would 
have to be generated by an examiner and another round of communications 
would be needed if applicant suggests a restriction requirement and it 
is not accepted by the Office.
    Response: Since the examination support document is required 
whenever applicant presents more than five independent claims or more 
than twenty-five total claims and the notice only applies when it 
appears that the omission of the examination support document was 
inadvertent, the Office expects that the number of notices would be 
relatively low. Furthermore, the Office plans to have a notice under 
Sec.  1.75(b)(3) generated by someone other than the examiner. While it 
may be necessary on occasion for the examiner to communicate with the 
applicant if a suggested restriction requirement is not accepted, this 
additional communication is far outweighed by the benefits of focused 
examination and increased quality.
    Comment 213: Several comments requested that the Office explain the 
procedures for how the Office will evaluate a suggested restriction 
requirement. Some comments questioned how an examiner will approve a 
suggested restriction requirement. One comment questioned what would 
occur if the restriction requirement was not accepted by the examiner.
    Response: As discussed previously, if the applicant submits a 
suggested restriction requirement, the suggested restriction 
requirement is accepted, and there are five or fewer independent claims 
and twenty-five or fewer total claims to the elected invention, the 
Office will simply treat the non-elected claims as withdrawn from 
consideration and proceed to act on the application (assuming the 
application is otherwise ready for action). The Office action will set 
out the requirement for restriction under Sec.  1.142(a), e.g., in the 
manner that an Office action on the merits would contain a written 
record of a requirement for restriction previously made by telephone. 
See MPEP section 810.
    The refusal to accept a suggested requirement for restriction may 
result in the examiner making a different restriction requirement or 
making no restriction requirement. If the examiner makes a restriction 
requirement (different from the suggested restriction requirement), the 
applicant will be notified (a notice under Sec.  1.75(b)(3) coupled 
with a restriction requirement) and given a time period within which 
the applicant must make an election. In addition, if there are more 
than five independent claims or more than twenty-five total claims to 
the elected invention and/or species, the applicant must also: (1) 
Amend the application such that it contains no more than five 
independent claims and no more than twenty-five total claims to the 
elected invention and/or species; or (2) file an examination support 
document in compliance with Sec.  1.265 that covers each claim (whether 
in independent or dependent form) to the elected invention and/or 
species.
    Comment 214: Several comments argued that the rules should provide 
guidance on how the non-extendable deadline would be treated in the 
event of a petition or appeal relating to the requirement for an 
examination support document. Several comments questioned how the 
notice and time period would be set when there are multiple 
applications that have patentably indistinct claims that are being 
considered together for purposes of determining the number of claims in 
an application.
    Response: Applicant may file a petition under Sec.  1.181 if the 
applicant disagrees with a determination that an application contains 
more than five independent claims or more than twenty-five total 
claims, or a determination that an examination support document does 
not comply with Sec.  1.265. As stated in Sec.  1.181(f), the mere 
filing of a petition will not stay any time period that may be running 
against the application. Applicant must file a reply in compliance with 
Sec.  1.75(b)(3) within the two-month time period to avoid abandonment 
even when applicant files a petition under Sec.  1.181. If there are 
multiple applications with at least one patentably indistinct claim, 
the Office will issue a notice under Sec.  1.75(b)(3) in each 
application and set a separate time period in each application.
    Comment 215: Several comments argued that applicants would file 
more applications in parallel with fewer claims to avoid having to file 
an examination support document and this would create more work for the 
Office.
    Response: This final rule provides that if multiple applications 
contain at least one patentably indistinct claim, the Office will treat 
the multiple applications as a single application for purposes of 
determining whether each of the multiple applications exceeds the five 
independent claim and twenty-five total claim threshold. See Sec.  
1.75(b)(4). For example, if one of the claims in an application is 
patentably indistinct from at least one of the claims in another 
application, the Office will treat each application as containing the 
total of all of the claims in both applications when determining 
whether each application exceeds the five independent claim and twenty-
five total claim threshold. This

[[Page 46798]]

provision is intended to prevent an applicant from submitting multiple 
applications to the same subject matter, each with five or fewer 
independent claims or twenty-five or fewer total claims, for the 
purposes of avoiding the requirement to submit an examination support 
document. Furthermore, under Sec.  1.78(f), applicant is required to 
identify such applications if they: (1) Have filing dates that are the 
same as or within two months of each other, taking into account any 
filing date for which a benefit is sought under title 35, United States 
Code; (2) name at least one inventor in common; and (3) are owned by 
the same person, or subject to an obligation of assignment to the same 
person. If the applications also have the same claimed filing or 
priority date and substantially overlapping disclosures, applicant must 
rebut a presumption that the applications contain patentably indistinct 
claims or file a terminal disclaimer and provide good and sufficient 
reasons why two or more such pending applications are required rather 
than one. See Sec. Sec.  1.78(f)(2) and (f)(3).
    Comment 216: One comment questioned whether the Office would 
require an examination support document if a parent application issues 
as a patent with ten claims and a continuation application is filed 
with indistinct claims.
    Response: The Office has revised Sec.  1.75(b)(4) to provide that 
if there are multiple applications containing at least one patentably 
indistinct claim the Office will treat each of such applications as 
containing the total of all of the claims (both independent and 
dependent) present in all of the multiple applications containing 
patentably indistinct claims for purposes of determining whether each 
such application contains more than five independent claims or more 
than twenty-five total claims. Under Sec.  1.75(b)(4), the Office will 
count the claims in copending applications containing patentably 
indistinct claims (including applications having a continuity 
relationship) but not in issued patents containing patentably 
indistinct claims, in determining whether each such application 
contains more than five independent claims or more than twenty-five 
total claims and thus whether an examination support document in 
compliance with Sec.  1.265 is required. As discussed previously, this 
provision is to preclude an applicant from submitting multiple 
applications to the same subject matter (with claims that are 
patentably indistinct), each with five or fewer independent claims or 
twenty-five or fewer total claims, for the purposes of avoiding the 
requirement to submit an examination support document in compliance 
with Sec.  1.265. Although claims in an issued patent are not counted 
for the purposes of Sec.  1.75(b)(4), the pending application may still 
be subject to a double patenting rejection.
    Comment 217: One comment questioned how the Office would determine 
when an examination support document was ``inadvertently'' omitted.
    Response: If the omission of an examination support document is an 
isolated instance, then generally the omission would be considered 
inadvertent. Where, however, a particular individual (e.g., applicant 
or attorney) has a pattern of not including an examination support 
document when required, then the Office would be less inclined to 
consider such an omission as being inadvertent. The Office will not 
generally question whether the omission of an examination support 
document was inadvertent unless there is a reason to do so.

H. Examination Support Document Requirements

    Comment 218: Several comments supported the concept of an 
examination support document. One comment agreed that the examination 
support document would help the Office to reduce the backlog.
    Response: The Office is adopting the concept of an examination 
support document in this final rule. Under this final rule, an 
examination support document is required if applicant presents more 
than five independent claims or more than twenty-five total claims in 
an application.
    Comment 219: A number of comments argued that the search and 
analysis necessary to prepare an examination support document would add 
significant cost to the preparation of an application, that the cost 
would be significantly more than the $2,500 predicted by the Office, 
and that this would significantly disadvantage independent inventors 
and small businesses. Several comments argued that it would be 
unaffordable for independent inventors and small entities. Several 
comments argued that the patentability search done by most 
practitioners is limited to United States patents and United States 
published applications and does not generally set forth in detail the 
patentability of each claim element by element. A number of comments 
argued that the examination support document was more like a validity 
search and opinion and included various estimates of the cost of 
preparing an examination support document, which ranged from $5,000 to 
$30,000. One comment argued that it would cost a minimum of $30,000 for 
a biotechnology application. One comment argued that even if the 
Office's estimate is accurate, it would cost a small entity applicant 
$3,000 to have twenty claims examined, which would be a six hundred 
percent increase over current costs and would have a significant 
economic impact.
    Response: As discussed previously, the Office has modified the 
proposed rules with respect to claims. Under the proposed rules, 
applicants who wished to have more than ten representative claims 
examined in the initial Office action would have had to file an 
examination support document. Under the changes in this final rule, 
applicants may have up to five independent and twenty-five total claims 
examined in an application without filing an examination support 
document.
    The Office was given feedback that the costs for preparing an 
examination support document could be anywhere from $5,000 to $100,000. 
No data to support the alleged costs were submitted. Contrary to some 
of the comments, the Office is not requiring a validity search and 
opinion. The pre-filing preparation of an application that contains 
more than five independent claims or more than twenty-five total claims 
should involve obtaining a patent novelty search, analysis and opinion. 
Preparation of an examination support document requires that this 
information be reduced to writing in a particular format.
    The Office commissioned a detailed analysis of the final rule's 
impacts on small entities. This analysis indicated that the cost of an 
examination support document is likely to be in the range of $2,563 to 
$13,121. This analysis also concludes that this final rule is not 
expected to result in a significant economic impact on a substantial 
number of small entities. This final rule does provide an exemption 
from the requirement (Sec.  1.265(a)(3)) that an examination support 
document must, for each reference cited in the listing of the 
references required under Sec.  1.265(a)(2), include an identification 
of all the limitations of each of the claims that are disclosed by the 
reference that applies to applications by a small entity as defined by 
the Regulatory Flexibility Act (5 U.S.C. 601 et seq.). See Sec.  
1.265(f).
    Comment 220: Several comments argued that the examination support 
document is substantially more burdensome than the current procedure 
for accelerated examination because the search and examination support

[[Page 46799]]

document must separately address every claim for which examination is 
sought, and the rule contains substantial additional burdens. One 
comment argued that the accelerated examination procedure is too 
onerous as shown by the very small number of applicants who used the 
procedure, and the examination support document is even more stringent. 
Several comments argued that a petition to make special is voluntary, 
not mandatory. Furthermore, such a petition does not foreclose 
applicant's opportunity to pursue additional inventive subject matter 
to protect against design-arounds, as would happen in view of the 
concurrent continuation proposed rule changes.
    Response: The Office has reduced the requirements for an 
examination support document under Sec.  1.265 as adopted in this final 
rule. The Office proposed to require applicants to provide a detailed 
explanation of how each independent and dependent claim was patentable 
over the cited art (proposed Sec.  1.261(a)(4)). Section 1.265(a)(4) as 
adopted in this final rule requires applicants to provide the same 
explanation for the independent claims only. The Office also proposed 
to require applicants to provide statements of utility of the invention 
as defined in each independent claim (proposed Sec.  1.261(a)(5)). 
Section 1.265 as adopted in this final rule does not include such a 
requirement. These changes reduce the requirements for applicants who 
wish to file an examination support document while still providing 
examiners with valuable information to assist in the examination of 
applications.
    Furthermore, an examination support document in compliance with 
Sec.  1.265 is required under Sec.  1.75(b) only when an applicant 
presents more than five independent claims or more than twenty-five 
total claims. It is not required in applications that contain five or 
fewer independent claims and twenty-five or fewer total claims. Thus, 
the majority of applications would not need an examination support 
document since a majority of applications contain five or fewer 
independent claims and twenty-five or fewer total claims.
    In addition, the accelerated examination procedure was recently 
revised. The accelerated examination procedure has more requirements 
than are contained in Sec.  1.265. See Changes to Practice for 
Petitions in Patent Applications To Make Special and for Accelerated 
Examination, 71 FR at 36323-27, 1308 Off. Gaz. Pat. Office 106-09. For 
example, the accelerated examination support document must also 
identify any cited references that may be disqualified as prior art 
under 35 U.S.C. 103(c) as amended by the Cooperative Research and 
Technology Enhancement (CREATE) Act (Pub. L. 108-43, 118 Stat. 3596 
(2004)).
    Comment 221: Several comments argued that due to the cost and 
``duty to search,'' the requirement for an examination support document 
is tantamount to imposing a de facto limit on the number of claims in 
an application.
    Response: The Office has not placed a de facto limit on the number 
of claims. If an applicant wants to present more than five independent 
claims or more than twenty-five total claims, the applicant simply 
needs to submit an examination support document in compliance with 
Sec.  1.265 before the first Office action on the merits. As discussed 
previously, the accelerated examination procedure has more requirements 
than are contained in Sec.  1.265. However, over four hundred 
applications have been filed under the revised accelerated examination 
procedure in the last nine months.
    Comment 222: One comment suggested that Sec.  1.265 should be 
replaced by a requirement that applicant comply with the rules for a 
petition to make special. Another comment argued that applicants will 
file a petition to make special after going through the effort and 
expense to prepare and file an examination support document.
    Response: As discussed previously, the Office has recently revised 
its accelerated examination program with the goal of completing 
examination within twelve months of the filing date of the application. 
An application containing more than five independent claims or more 
than twenty-five total claims would not be eligible for the revised 
accelerated examination program. Nevertheless, the Office has no 
objection to every applicant filing his or her application under the 
revised accelerated examination program.
    Comment 223: A number of comments argued that the requirement for 
an examination support document transfers to the applicant the costs 
and responsibilities of the examination process for which fees have 
been paid. One comment questioned why applicant must pay a search fee 
and perform a search of their own in order to prepare an examination 
support document. One comment suggested that the Office should consider 
eliminating the search and examination fee when an examination support 
document is provided. One comment argued that the excess claims fees 
that are paid are more than enough to cover the associated extra 
expense and burden placed on the Office in examining the excess claims. 
One comment suggested that the excess claims fee should be increased 
rather than requiring applicants to submit an examination support 
document.
    Response: Applications which contain a large number of claims 
absorb an inordinate amount of patent examining resources, and such 
applications are extremely difficult to process and examine properly. 
An applicant who presents more than five independent claims or more 
than twenty-five total claims will be required to assist the Office 
with the examination by providing an examination support document in 
compliance with Sec.  1.265. The Office will still conduct a search and 
examine an application in which an examination support document is 
filed. Furthermore, the search and examination fees and excess claims 
fees do not recover the costs of searching and examining an 
application. The higher cost estimates provided in the comments on the 
Claims Proposed Rule confirm that the cost of conducting a search and 
preparing an analysis far exceeds the search and examination fees. The 
Office, however, cannot increase these fees because they are set by 
statute.
    Comment 224: Several comments argued that the examination support 
document imposes extra burdens on the applicants that are not performed 
by the Office since applicants are required to translate any foreign 
documents not in the native language of the applicant and rejections by 
the Office do not comply with most of the requirements imposed under 
the rule.
    Response: Examiners frequently obtain translations of foreign 
documents that they consider to be pertinent. Examiners must obtain a 
translation of any document that is in a language other than English if 
the examiner seeks to rely on that document in a rejection. See MPEP 
Sec.  706.02. During examination, examiners cite references that are 
most closely related to the subject matter of the claims, identify the 
limitations of the claims that are disclosed by the references being 
relied upon in a rejection, explain how each of the independent claims 
are being rejected over the references being applied, and make 
determinations regarding utility and 35 U.S.C. 112, ] 1, support and 
enablement. The requirements in Sec.  1.265 are intended to assist the 
examiner with the examination process.
    Comment 225: Several comments stated that the costs and 
requirements of an examination support document would encourage 
applicants to seek the services of the least qualified searchers.

[[Page 46800]]

    Response: The Office is not encouraging applicants to seek the 
services of the least qualified searchers. An applicant who decides to 
file an examination support document has the option to seek the 
services of any searcher he or she chooses or to conduct the 
preexamination search on his or her own. Applicant should have an 
incentive to hire the most qualified searchers since a better search is 
more likely to result in a more thorough examination. The requirements 
of an examination support document are clearly set forth in Sec.  1.265 
and an applicant who chooses to file an examination support document 
must satisfy these requirements. If the preexamination search is poor, 
then applicant runs the risk that the preexamination search or the 
examination support document will be deemed insufficient. If the 
preexamination search or examination support document is deemed 
insufficient, applicant will be given only a two-month time period that 
is not extendable under Sec.  1.136(a) in which to file a corrected 
examination support document to avoid abandonment of the application. 
See Sec.  1.265(e).
    Comment 226: One comment argued that the Office's estimate that the 
burden imposed by the rule change will equate to an additional one 
minute and forty-eight seconds to twelve hours was unrealistic for 
applications having multiple independent claims and hundreds of pieces 
of prior art to be reviewed.
    Response: The one minute and forty-eight seconds to twelve hours 
response time provided in the notice of proposed rule making covered 
each activity that may occur during the processing of an application 
for patent (OMB control number 0651-0031). The specific estimate for an 
examination support document was twelve hours (which has subsequently 
been increased to twenty-four hours). While the Office received 
comments suggesting that the Office's cost estimate for an examination 
support document was low, these comments provided only conclusory 
statements and contained few facts or information.
    Comment 227: A number of comments argued that it was almost 
impossible to determine the extent to which the prior art must be 
searched to satisfy the preexamination search requirement. Several 
comments argued that there is no way to meet the search requirements. 
One comment argued that it would be impossible to prove the ``non-
existence'' of more pertinent art. A number of comments argued that the 
search should not be required to go beyond the resources that are 
publicly available in the Office's search room. One comment suggested 
that the Office's search room would need to be upgraded to allow access 
to all foreign patents, periodicals and publications as well as all 
United States patents to meet the examination support document 
requirements. Several comments argued that applicant would be required 
to conduct a search that is beyond the scope of the searches performed 
by examiners and that this was unfair and burdensome to the applicants. 
Some comments argued that the information that must be identified is 
significantly more than what the Office provides to an applicant for a 
search and that a requirement for a statement that applicant has 
searched on the Office's database, the resources available to 
examiners, should be sufficient.
    Response: The standard for the preexamination search that is 
required is the same standard that the Office uses to examine patent 
applications, which is set forth in MPEP Sec. Sec.  904-904.03. The 
information that applicant must identify is the same information that 
the examiner must record in the application file as set forth in MPEP 
Sec.  719.05. If applicant follows the search guidelines set forth in 
the MPEP, then the preexamination search should be sufficient. The 
Office has published patent search templates to define the field of 
search, search tools, and search methodologies that should be 
considered when performing a search. The search templates are published 
on the Office's Internet Web site at http://www.uspto.gov/web/patents/searchtemplates/. The Office has requested comments on the patent 
search templates. See Request for Comments on Patents Search Templates, 
71 FR 94 (May 16, 2006), 1307 Off. Gaz. Pat. Office 22 (Jun. 6, 2006).
    The accelerated examination procedure has more requirements than 
are contained in Sec.  1.265. See Changes to Practice for Petitions in 
Patent Applications To Make Special and for Accelerated Examination, 71 
FR 36232 (June 26, 2006), 1308 Off. Gaz. Pat. Office 106 (July 18, 
2006) (notice). Thus, the information concerning the requirements for a 
preexamination search document under the revised accelerated 
examination procedure can be applied to fulfill the requirements for a 
preexamination search under Sec.  1.265. See samples of a 
preexamination search document and an accelerated examination support 
document on the Office's Internet Web site at http://www.uspto.gov/web/patents/accelerated/.
    Finally, a statement that applicant has searched on the Office's 
database and the resources available to examiners would not be 
sufficient. A mere statement that the applicant has searched on the 
Office's database and the resources available to examiners would not 
identify the field of search, the date of the search, and, for database 
searches, the search logic or chemical structure or sequence used as a 
query, the name of the file or files searched and the database service, 
and the date of the search. See Sec.  1.265(a)(1).
    Comment 228: One comment argued that the fact that foreign search 
reports are not sufficient for the preexamination search or examination 
support document seemed at odds with the objective of promoting greater 
reliance on and use of work done by other competent patent offices. One 
comment questioned whether an international search report is sufficient 
to satisfy the search requirement, and if it is, then why are foreign 
patent office searches not sufficient.
    Response: Neither foreign search reports nor international search 
reports are per se excluded. If a foreign search report or an 
international search report satisfies the requirements for a 
preexamination search set forth in Sec.  1.265, then it would be 
accepted.
    Comment 229: One comment argued that the preexamination search 
requirement that the search must cover all the features of the 
designated dependent claims separately from the claim or claims from 
which the dependent claim depends makes no sense. The comment argued 
that if a dependent claim adds an element to the combination in an 
independent claim, a search for prior art references that disclose the 
additional element separately from the elements of the independent 
claim is likely to produce many references that have no relation to the 
invention. The comment suggested that the language of the rule be 
revised to clarify that the preexamination search must include a 
separate search for each independent claim and each designated 
dependent claim.
    Response: As discussed previously, the Office did not adopt the 
``representative claims'' examination approach. Under this final rule, 
if the application contains more than five independent claims or more 
than twenty-five total claims, applicant is required to file an 
examination support document in compliance with Sec.  1.265 that covers 
each of the claims (whether in independent or dependent form) before 
the first Office action on the merits. If an examination support 
document in compliance with Sec.  1.265 is

[[Page 46801]]

not filed before the issuance of a first Office action on the merits of 
the application, the application may not contain or be amended to 
contain more than five independent claims or more than twenty-five 
total claims. The Office has revised Sec.  1.265(b) to delete the 
phrase ``separately from the claim or claims from which the dependent 
claim depends.'' Section 1.265(b) as adopted in this final rule 
requires that the preexamination search must encompass all of the 
features of the claims (whether independent or dependent), giving the 
claims the broadest reasonable interpretation. For example, if 
independent claim 1 recites elements ABC and dependent claim 2 depends 
on claim 1, incorporates all the limitations of claim 1 and 
additionally recites element D, then, even if applicant cannot find 
elements ABC and believes elements ABC to be novel, applicant must 
still search for element D.
    Comment 230: One comment argued that the requirement that the 
search encompass the ``disclosed features that may be claimed'' should 
be deleted because it gives examiners carte blanche to reject 
preexamination searches on essentially arbitrary grounds.
    Response: The Office notes the concerns expressed in the public 
comment. The Office has modified the proposed provision such that Sec.  
1.265(b) as adopted in this final rule does not require that the 
preexamination search must encompass the disclosed features that may be 
claimed. For any amendment to the claims that is not encompassed by the 
examination support document, however, applicants are required to 
provide a supplemental examination support document that encompasses 
the amended or new claims at the time of filing the amendment.
    Comment 231: Several comments suggested that there should be an 
exemption from the limits on the number of claims for independent 
inventors. One comment argued that many individual inventors lack the 
skills and requisite knowledge to perform an adequate preexamination 
search and prepare an examination support document.
    Response: The applicant of a patent application should have 
sufficient knowledge of his or her own invention. Performing a 
preexamination search and preparing an examination support document 
should be no more difficult than preparing and prosecuting the patent 
application. Furthermore, applicants can avoid the need to file an 
examination support document by not presenting more than five 
independent claims or more than twenty-five total claims in an 
application. This final rule, however, provides that a small entity as 
defined by the Regulatory Flexibility Act (5 U.S.C. 601 et seq.) may 
claim an exemption from the requirement in Sec.  1.265(a)(3) for an 
identification of all of the limitations of each of the claims that are 
disclosed by the references cited in the listing of the references 
required under Sec.  1.265(a)(2). See Sec.  1.265(f).
    Comment 232: One comment suggested that the Office should hire 
experienced searchers to perform the searching function.
    Response: The Office has recently conducted a pilot using PCT 
international applications for competitively sourcing search functions 
to commercial entities, each of which had experience in providing 
patent searches. The purpose of the pilot program was to demonstrate 
whether searches conducted by commercial entities could meet or exceed 
the standards of searches conducted and used by the Office during the 
patent examination process. The pilot was not proved successful and was 
concluded after six months.
    Comment 233: A number of comments argued that the rules requiring 
an examination support document are fraught with dangers in the form of 
inequitable conduct allegations and malpractice. One comment argued 
that there would be challenges on the sufficiency of the examination 
support document, the scope of the search of the examination support 
document, and the timing of the search for the examination support 
document. A number of comments argued that even a good faith attempt is 
likely to be attacked on the grounds of inequitable conduct, and that 
such a duty is contrary to Frazier v. Roessel Cine Photo Tech., Inc., 
417 F.3d 1230, 75 U.S.P.Q.2d 1822 (Fed. Cir. 2005). A number of 
comments argued that the risk of inequitable conduct allegations in 
litigation would effectively force applicants to file ten or fewer 
claims, which would deny them the right to adequately protect their 
inventions. Several comments argued that each patent that includes an 
examination support document in its file history would be inherently 
weak given current inequitable conduct practices. Several comments 
argued that the likelihood of having to defend against inequitable 
conduct would reduce perceived public confidence in the validity of 
issued patents. Several comments also argued the examination support 
document will increase litigation costs. Several comments also argued 
that the added costs in terms of the perceived reduction in patent 
quality and the potential litigation costs would outweigh any potential 
speed of examination benefit. One comment argued that forcing 
applicant's representatives to limit the claims to an arbitrary number 
is akin to asking them to commit what amounts to malpractice. One 
comment stated that the rules put applicants in a triple-jeopardy 
situation for losing patent rights. First, because examiners will not 
consider all initially filed claims, applicants are put in jeopardy of 
having to file continuations for unexamined claims. Second, if 
applicants choose to have more than the threshold number of claims, 
applicants risk inequitable conduct charges. Third, if only the 
threshold number of claims is pursued, applicants will be unable to 
adequately protect their inventions.
    Response: Applicants may present as many claims as they feel are 
necessary to adequately protect their invention. Under this final rule, 
applicant may present up to five independent claims and twenty-five 
total claims for examination in an application without providing an 
examination support document. As discussed previously, the Office has 
also modified the proposed changes to continuing application practice 
and continued examination practice to permit an applicant to file two 
continuation or continuation-in-part applications plus one request for 
continued examination in an application family, without any 
justification. Thus, an applicant is permitted to present up to fifteen 
independent claims and seventy-five total claims for each patentably 
distinct invention via an initial application and two continuation or 
continuation-in-part applications that are prosecuted serially without 
providing either an examination support document or a justification. 
Applicant may also present additional claims by submitting an 
examination support document under Sec.  1.265 before the first Office 
action on the merits.
    The changes in this final rule do not force an applicant to carry 
any affirmative duty that may expose him or her to a greater risk of 
inequitable conduct. The submission of an examination support document 
to assist the Office in gathering information for use during 
examination does not expose an applicant to a greater risk of 
inequitable conduct. Inequitable conduct is a doctrine based, in part, 
upon ``intent to deceive.'' See Molins PLC v. Textron, Inc., 48 F.3d 
1172, 1178, 33 U.S.P.Q.2d 1823, 1826 (Fed. Cir. 1995). To establish 
inequitable conduct, a party must provide clear and convincing evidence 
of: (1) Affirmative misrepresentations of a material fact,

[[Page 46802]]

failure to disclose material information, or submission of false 
material information; and (2) an intent to deceive. See, e.g., Impax 
Labs., Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1374, 81 U.S.P.Q.2d 
1001, 1006 (Fed. Cir. 2006) (citing Alza Corp. v. Mylan Labs., Inc., 
391 F.3d 1365, 1373, 73 U.S.P.Q.2d 1161, 1167 (Fed. Cir. 2004)). Absent 
such ``intent to deceive'', inequitable conduct cannot be proven. 
Unless the applicant has an ``intent to deceive'' when submitting an 
examination support document, the simple submission of an examination 
support document, even one containing erroneous information, to the 
Office does not by itself raise an intent to deceive or mislead the 
Office. See Frazier, 417 F.3d at 1236 n.1, 75 U.S.P.Q.2d at 1826 n.1 
(the mere submission of erroneous information to the Office does not by 
itself raise an inference of intent to deceive or mislead). Moreover, 
frivolous allegations in litigation are subject to professional 
responsibility rules and Rule 11 of the Federal Rules of Civil 
Procedure.
    Comment 234: A number of comments argued that the Office must 
create a ``safe harbor'' that appropriately protects the applicant from 
inequitable conduct allegations when identifying and characterizing 
important prior art. Several comments argued that changes to Sec.  1.56 
would need to be made to exempt examination support documents from it. 
One comment argued that legislative reform is needed. Several comments 
argued that implementation of the examination support document should 
be delayed until changes to inequitable conduct are made. A number of 
comments suggested that more meaningful participation by applicants in 
prosecution of the application requires adequate ``safe-harbor'' 
provisions from inequitable conduct.
    Response: The Office proposed revising Sec.  1.56 to provide a 
``safe harbor'' to applicants who make a reasonable good faith effort 
to comply with the proposed requirements. See Changes To Information 
Disclosure Statement Requirements and Other Related Matters, 71 FR at 
38811-12, 38820, 1309 Off. Gaz. Pat. Office at 27, 34. Most of the 
comments indicated that such a ``safe harbor'' at best sets out the 
current state of the law of inequitable conduct, in that a ``safe 
harbor'' is unnecessary for applicants who act in good faith (i.e., 
without an intent to deceive or mislead the Office) because an intent 
to deceive or mislead the Office is a separate and essential component 
of inequitable conduct. See e.g., Weatherchem Corp. v. J.L. Clark, 
Inc., 163 F.3d 1326, 1336, 49 U.S.P.Q.2d 1001, 1009 (Fed. Cir. 1998) (a 
finding that the patentee acted without any intent to deceive disposes 
of the inequitable conduct issue), and Manville Sales Corp. v. 
Paramount Systems Inc., 917 F.2d 544, 552, 16 U.S.P.Q.2d 1587, 1593 
(Fed. Cir. 1990) (materiality does not presume intent, which is a 
separate and essential component of inequitable conduct). The comments 
also expressed concern that any ``safe harbor'' would possibly create 
new requirements with respect to an applicant's duty of disclosure 
under Sec.  1.56. It is the Office's position that an applicant's duty 
of disclosure under Sec.  1.56 with respect to an examination support 
document under Sec.  1.265 is satisfied if an individual as defined in 
Sec.  1.56(c) acted in good faith to comply with the requirements in 
Sec.  1.265 for an examination support document. The Office, however, 
is not adopting changes to Sec.  1.56 in this final rule to provide a 
``safe harbor'' to applicants because such a provision would be 
unnecessary. The Office notes that patent reform legislation is pending 
in the 110th Congress before both the Senate and House of 
Representatives. See Patent Reform Act of 2007, S. 1145, 110th Cong. 
(2007), and H.R. 1908, 110th Cong. (2007). The Department of Commerce 
submitted a letter on May 18, 2007, to the Chairman of the House 
Subcommittee on Courts, the Internet, and Intellectual Property 
recommending that H.R. 1908 be amended to address the doctrine of 
inequitable conduct and unenforceability to ensure that patent 
applicants are not discouraged from fully and fairly sharing relevant 
information with the Office.
    Comment 235: A number of comments argued that the examination 
support document would require the applicant to make binding admissions 
as to the scope of the claims and how they relate to the prior art 
references and thus force applicant to create prosecution history 
estoppel and address rejections that would never have occurred during 
prosecution. Several comments argued that such a requirement shows a 
complete lack of understanding of the pitfalls that admissions can have 
in litigation. Several comments argued that such statements can be 
misinterpreted and distorted in unforeseen ways. One comment argued 
that this may cause the practitioner to unintentionally and 
unnecessarily narrow the claims through the effect of prosecution 
history estoppel, which will decrease the commercial value and the 
quality of the patent. Several comments argued that the requirement for 
an examination support document places applicant in a precarious 
position of having to provide as much information as possible to 
support patentability of the claimed invention while avoiding 
statements that can be easily manipulated in litigation. One comment 
argued that applicants would be put in a position of having to make 
statements against interest long before the scope of their invention is 
realized. One comment argued that requiring applicant to examine his or 
her own application creates a conflict of interest, which would raise a 
question of concealment or understatement.
    Response: The best way to avoid prosecution history estoppel is by 
knowing what the prior art is and filing claims that initially define 
patentable subject matter without having to file an amendment. 
Conducting a preexamination search and preparing an examination support 
document will help applicants to draft a better written disclosure and 
more focused claims, thereby minimizing any prosecution history 
estoppel.
    Comment 236: Several comments argued that the one-month non-
extendable time period to respond to a notice requiring a corrected or 
supplemental examination support document is insufficient. Some 
comments suggested that a three-month time period, which is extendable 
up to six months with an extension of time, should be given. Some 
comments suggested that the time period should be at least three months 
or extensions of time should be permitted.
    Response: The Office notes the concerns expressed in the public 
comment regarding the time period set forth in a notice requiring a 
corrected or supplemental examination support document when an 
examination support document is deemed to be insufficient. The Office 
has revised the proposed provision such that Sec.  1.265(e) provides a 
two-month time period that is not extendable under Sec.  1.136(a). The 
two-month time period should be more than sufficient to correct any 
minor deficiencies. Applicants, however, should not rely on the two-
month time period in Sec.  1.265(e) to prepare an examination support 
document or a supplemental examination support document. The 
requirements for an examination support document are clearly set forth 
in Sec.  1.265. Applicant should prepare the examination support 
document in compliance with the requirements before presenting more 
than five independent claims or more than twenty-five total claims. 
Applicant

[[Page 46803]]

should also conduct the preexamination search to encompass all of the 
disclosed features that applicant expects to claim in order to avoid 
the need to update the preexamination search. Applicant should file a 
supplemental examination support document at the time applicant 
presents any amendment to the claims that is not covered by the 
previous examination support document. Applicant also has the option of 
canceling the requisite number of claims (independent or total) that 
necessitate an examination support document, rather than submitting a 
corrected or supplemental examination support document. Furthermore, 
extensions of this two-month time period in Sec.  1.265(e) are 
available to those for which there is sufficient cause (Sec.  
1.136(b)).
    Comment 237: One comment suggested that if applicant's examination 
support document is deemed insufficient, applicant should be afforded 
an opportunity to undesignate claims, and if applicant fails to 
undesignate the claims or file a corrected examination support 
document, then the examiner should undesignate claims and proceed with 
examination, rather than holding the application abandoned.
    Response: The Office is not adopting the ``representative claims'' 
examination approach in this final rule. Thus, designation (or 
``undesignation'') of dependent claims for initial examination is not 
required in this final rule. Under this final rule, if applicant wants 
to present more than five independent claims or more than twenty-five 
total claims in an application, applicant simply needs to submit an 
examination support document in compliance with Sec.  1.265 before the 
first Office action on the merits. If applicant files an examination 
support document and it is insufficient, the Office will notify the 
applicant and give the applicant the options of either: (1) Filing a 
corrected or supplemental examination support document in compliance 
with Sec.  1.265 that covers each of the claims (whether in independent 
or dependent form); or (2) amending the application such that it 
contains no more than five independent claims and no more than twenty-
five total claims.
    Comment 238: One comment argued that applicant should be given the 
options available under Sec.  1.75(b)(3) and not be limited to 
submission of a corrected or supplemental examination support document 
when an examination support document is deemed to be insufficient or in 
other situations under Sec.  1.265(e) (Sec.  1.261(c) as proposed).
    Response: The Office notes the concerns expressed in the public 
comment regarding the proposed provision that requires a corrected or 
supplemental examination support document when an examination support 
document is deemed insufficient. The Office has modified this proposed 
provision such that Sec.  1.265(e) provides that if an examination 
support document is insufficient, the Office will notify the applicant 
and give the applicant the options of either: (1) Filing a corrected or 
supplemental examination support document in compliance with Sec.  
1.265 that covers each of the claims (whether in independent or 
dependent form); or (2) amending the application such that it contains 
no more than five independent claims and no more than twenty-five total 
claims. However, applicants will not be given the option to submit a 
suggested requirement for restriction. Such an option would not be 
appropriate after applicant has already submitted an examination 
support document.
    Comment 239: A number of comments requested clarification on how 
the Office would use an examination support document. Some comments 
questioned whether an independent search would be conducted and whether 
the cited references would be independently evaluated by the examiner. 
One comment noted that if the examiner simply adopts the results of the 
search and the conclusions of patentability, there would be a wide 
variation in quality and thoroughness of the searches performed, and in 
the quality of analysis of the search results. The comment further 
argued that if the examiner will perform further searching, then it was 
difficult to understand how the objective of ``sharing the burden'' is 
accomplished, since it would not seem to yield time or cost savings for 
the Office. Several comments argued that examiners should not give any 
faith and credit to the information in an examination support document. 
One comment argued that if the examiner does rely on the external 
search, the uncertainty of the patent will be increased. Another 
comment argued that the submission of an examination support document 
may motivate examiners to skip doing a thorough search, thus leading to 
lower patent quality. One comment argued that requiring an examination 
support document was a punitive measure because: (1) The examination 
support document requires information that is rarely if ever required, 
such as details regarding literal support for the claim elements; (2) 
the Office does not indicate that examiners will receive additional 
time to review the examination support document; and (3) the Office has 
not indicated that it will rely on the external search.
    Response: Upon taking up an application for examination, the 
examiner will consider the prior art submitted in an information 
disclosure statement in compliance with Sec. Sec.  1.97 and 1.98 (see 
Sec.  1.97(b)) and those filed with an examination support document in 
compliance with Sec.  1.265 (required under Sec.  1.75(b)), and make a 
thorough investigation of the available prior art related to the 
subject matter of the claimed invention (see Sec.  1.104(a)(1)). The 
examiner will make an independent patentability determination in view 
of the prior art on the record, other information in the examination 
support document, and any other relevant prior art or evidence. The 
examination support document will assist the examiner in the 
examination process and the determination of patentability of the 
claims by providing the most relevant prior art and other useful 
information. It will help the examiner in understanding the invention 
and to focus on the relevant issues. The examination support document 
will also assist the examiner in evaluating the prior art cited by the 
applicant and in determining whether a claim limitation has support in 
the original disclosure and in any prior-filed application. The 
requirement for an examination support document is not a punitive 
measure, nor is it a substitute for the Office's examination. The 
information required in an examination support document is to assist 
the examiner with the more extensive examination of an application 
having more than five independent claims or more than twenty-five total 
claims.
    The Office has reduced the requirements for an examination support 
document under Sec.  1.265 as adopted in this final rule. The Office 
proposed to require applicants to provide a detailed explanation of how 
each independent and dependent claim was patentable over the cited art 
(proposed Sec.  1.261(a)(4)). Section 1.265(a)(4) as adopted in this 
final rule requires applicants to provide the same explanation for the 
independent claims only. The Office also proposed to require applicants 
to provide statements of utility of the invention as defined in each 
independent claim (proposed Sec.  1.261(a)(5)). Section 1.265 as 
adopted in this final rule does not include such a requirement. These 
changes reduce the requirements for applicants who

[[Page 46804]]

wish to file an examination support document while still providing 
examiners with valuable information to assist in the examination of 
applications.
    Comment 240: Several comments questioned how the Office would 
determine if an examination support document is insufficient. Some 
comments also questioned what would happen if the Office knows of 
closer prior art than that cited by applicant. One comment questioned 
whether the examiner could hold the examination support document non-
compliant if the examiner objects to the search or the claim scope and 
also what would be applicant's remedy. Several comments argued that 
applicants currently disregard Sec. Sec.  1.56, 1.97 and 1.98 and fail 
to cite their own work. The comments argued that applicant will cite 
generic references to comply with Sec.  1.265 and will likely not 
reveal the most pertinent art. One comment argued that the examination 
support document requirements are subjective. One comment suggested 
that the Office should institute a petition process for disputing the 
requirement for an examination support document or the holding that an 
examination support document is insufficient. The comment suggested 
that the requirement should be stayed pending the outcome of the 
petition, or applicants should at least be given sufficient time for 
the petition to be heard.
    Response: The Office will review an examination support document to 
determine if it meets all the requirements set forth in Sec.  1.265. As 
discussed previously, the accelerated examination procedure has more 
requirements than are contained in Sec.  1.265. The Office has provided 
guidelines for examination support documents filed under the 
accelerated examination procedure. The Office's guidelines concerning 
the accelerated examination support document may be helpful to 
applicants who are preparing an examination support document under 
Sec.  1.265. The guidelines under the accelerated examination 
procedure, search templates, and samples of a preexamination search 
document and an examination support document are available on the 
Office's Internet Web site at http://www.uspto.gov/web/patents/accelerated/. The Office will provide similar guidelines for 
examination support documents under Sec.  1.265, including the 
preexamination search statement, and will post such guidelines on the 
Office's Internet Web site. These guidelines should minimize 
subjectivity in evaluating whether an examination support document 
complies with the requirements of Sec.  1.265.
    Section 1.265(a)(2) requires a listing of references deemed most 
closely related to the subject matter of each of the claims (whether in 
independent or dependent form). As discussed previously, the references 
that would be most closely related to the subject matter of each of the 
claims include: (1) A reference that discloses the greatest number of 
limitations in an independent claim; (2) a reference that discloses a 
limitation of an independent claim that is not shown in any other 
reference in the listing of references required under Sec.  
1.265(a)(2); and (3) a reference that discloses a limitation of a 
dependent claim that is not shown in any other reference in the listing 
of references required under Sec.  1.265(a)(2). References that are 
only relevant to the general subject matter of the claims would not be 
most closely related as long as there are other references that are 
more closely related to the subject matter of the claims. Applicant may 
not exclude a reference from an examination support document simply 
because the reference was not the result of the preexamination search 
provided for in Sec.  1.265(a)(1). References, from whatever source, 
that have been brought to the applicant's attention must be considered 
in determining the references most closely related to the subject 
matter of each of the claims. Accordingly, if applicant merely cites 
generic references and does not cite the most pertinent art (including 
applicant's own work), then the examination support document would most 
likely not be compliant with Sec.  1.265. Simply because the Office 
knows of a closer prior art reference (that is not applicant's own 
work) than the prior art cited by the applicant is generally not enough 
to hold a preexamination search insufficient.
    An examination support document could be deemed insufficient based 
on an insufficient search. If the preexamination search or examination 
support document is deemed insufficient, applicant will be given only a 
two-month time period that is not extendable under Sec.  1.136(a) in 
which to file a corrected examination support document or amend the 
application to contain five or fewer independent claims and twenty-five 
or fewer total claims to avoid abandonment of the application. See 
Sec.  1.265(e). Any applicant who disagrees with a requirement for an 
examination support document or the holding that an examination support 
document or preexamination search is insufficient may file a petition 
under Sec.  1.181. As provided in Sec.  1.181(f), the mere filing of a 
petition will not stay any period for reply that may be running against 
the application. The Office will make every effort to decide petitions 
in a timely manner.
    Comment 241: A number of comments argued that it was unfair and 
inconsistent for the Office to require applicants to produce an 
examination support document when the Office is not effectively using 
foreign search reports. One comment argued that since the Office is 
unwilling to accept a foreign search report or use international search 
reports prepared by the Office itself, the examination support document 
would not reduce pendency. Another comment argued that since examiners 
ignore international search reports they would not consider an 
examination support document.
    Response: The Office will consider any prior art submitted by 
applicant in an examination support document in compliance with Sec.  
1.265 (required under Sec.  1.75(b)) and an information disclosure 
statement in compliance with Sec. Sec.  1.97 and 1.98 including those 
that are filed with a foreign search report or an international search 
report. Any relevant prior art will assist the examiner in the 
determination of patentability of the claims. The examiner, however, 
must make an independent determination of patentability of the claims 
in the application. The examiner cannot accept the determination of 
patentability by another examiner in a foreign application or an 
international application because the patentability standard of a 
foreign or international application is different than the standard in 
a U.S. application.
    Comment 242: A number of comments argued that the requirement for 
an examination support document would create more work for the examiner 
since the examiner would have to determine the adequacy of the 
examination support document. One comment argued that complex cases 
would continue to be complex and the Office would just have the 
additional tasks of determining whether or not an examination support 
document should be required, and whether or not an examination support 
document is sufficient. One comment argued that examiners will not have 
sufficient time to review the examination support documents and that 
examiners would need more time for reviewing the examination support 
documents. The comment questioned whether this would take the place of 
the examiner reviewing the specification. Several

[[Page 46805]]

comments argued that determining the adequacy of examination support 
documents would divert resources from examination and prolong pendency. 
One comment argued that there would be additional burdens on the 
examiner in having to impose the requirement for designation of claims, 
issue communications challenging the sufficiency of the examination 
support document, perform a different search after claims are amended 
in response to an Office action, and search and examine the non-
designated claims after allowance of designated claims. One comment 
argued that the number of petitions would increase because of petitions 
regarding whether an examination support document was needed or 
defective.
    Response: Under this final rule, applicant is required to file an 
examination support document under Sec.  1.75(b)(1) if applicant 
presents more than five independent claims or more than twenty-five 
total claims in an application. If an examination support document in 
compliance with Sec.  1.265 is not filed before the issuance of a first 
Office action on the merits of the application, the application may not 
contain or be amended to contain more than five independent claims or 
more than twenty-five total claims. The majority of the applicants 
would not need to file an examination support document. The 
requirements of an examination support document are clearly set forth 
in Sec.  1.265. Applicants should comply with the requirements at the 
time applicant presents more than five independent claims or more than 
twenty-five total claims in an application. As discussed previously, 
any relevant prior art and other information provided in an examination 
support document will assist the examiner in the examination process 
and in the determination of patentability of the claims. During the 
examination process, the examiner will consider all relevant prior art 
and information, and interpret the claims in light of the 
specification. The examiner will review the specification even when 
applicant files an examination support document. Thus, the benefits 
obtained by the examination support document would outweigh the 
Office's additional task of determining whether or not it is sufficient 
or is required.
    Comment 243: One comment questioned whether the Office would give 
examiners less time to examine those applications in which an 
examination support document is filed and, if not, then how would the 
workload be reduced.
    Response: Changes to patent examiner production goals are beyond 
the scope of the proposed changes to the rules of practice. Therefore, 
whether examiners should be given less time to examine certain 
applications is not discussed in this final rule. The Office expects 
that these rule changes will result in a more focused quality 
examination. The information provided in the examination support 
document will assist the examiner with the more extensive examination 
of the application. This information will be available to the examiner 
up front and will include the most closely related references and a 
detailed explanation of how the claims are patentable over these 
references. As a result, the exchanges between examiners and applicants 
should be more efficient and effective, the number of Office actions 
should be reduced, prosecution should be concluded faster, and the need 
to file a continuation application or request for continued examination 
should be reduced. Thus, the Office's workload would be reduced.
    Comment 244: Several comments argued that the requirement for the 
broadest reasonable interpretation of the claims in conducting the 
search for an examination support document is inconsistent with current 
case law citing In re Johnston and In re Donaldson that require the 
Office to interpret the claims reasonably in light of the 
specification.
    Response: The requirement in Sec.  1.265(b) is consistent with 
current case law. The current case law requires that during examination 
the claims must be given their broadest reasonable interpretation 
consistent with the specification. According to case law, however, the 
broadest ``reasonable'' interpretation is necessarily one that is 
consistent with the specification. See, e.g., Phillips, 415 F.3d at 
1316, 75 U.S.P.Q.2d at 1329; In re Morris, 127 F.3d 1048, 1054, 44 
U.S.P.Q.2d 1023, 1027 (Fed. Cir. 1997) (``Some cases state the standard 
as the broadest reasonable interpretation, others include the qualifier 
consistent with the specification or similar language. Since it would 
be unreasonable for the PTO to ignore any interpretive guidance 
afforded by the applicant's written description, either phrasing 
connotes the same notion: As an initial matter, the PTO applies to the 
verbiage of the proposed claims the broadest reasonable meaning of the 
words in their ordinary usage as they would be understood by one of 
ordinary skill in the art, taking into account whatever enlightenment 
by way of definitions or otherwise that may be afforded by the written 
description contained in the applicant's specification.'') (citations 
omitted). Therefore, the reference in Sec.  1.265(b) to giving the 
claims ``the broadest reasonable interpretation'' is consistent with 
case law.
    Comment 245: One comment agreed that the requirements relating to 
the concise statement of utility and the 35 U.S.C. 112 showing is 
sharing the burden of examining all of the claims in the application, 
but argued that requiring applicant to characterize the prior art goes 
too far and is best left to the examiner since it is the examiner's 
role to review and analyze the prior art for patentability purposes in 
view of Sec.  1.104. Several comments argued that the burden of the 
examination belongs with the Office and that it is against the public 
interest to shift the burden from the examiner to the applicant. One 
comment argued that the examination support document requirement asks 
applicant to prove that patent claims are patentable, which is 
essentially impossible. One comment argued that the only purpose of an 
examination support document is to force applicants to do what they 
already should be doing, that is, carefully comparing their claims to 
every close prior art reference and adding limitations to distinguish 
the claims.
    Response: Ultimately it is the Office's responsibility to determine 
patentability. Nevertheless, it is appropriate for applicants to 
provide information regarding an initial review of claims to assist the 
Office in determining patentability in applications where they feel 
they need to have more than five independent claims or more than 
twenty-five total claims. There is no reasonable explanation as to why 
it is against public interest for an applicant who presents more than 
five independent claims or more than twenty-five total claims to 
provide additional information to the Office. The Office is not 
requiring applicants to prove that their claims are patentable. The 
Office is simply requiring applicants who present more than five 
independent claims or more than twenty-five total claims to provide 
additional information to the Office by conducting a preexamination 
search and submitting an examination support document. The Office 
agrees that applicants should be comparing their claims to every close 
prior art reference and adding limitations to distinguish the claims.
    Comment 246: One comment stated the Office should require a showing 
of precise written description (35 U.S.C. 112, ] 1) support for all 
amendments made by applicants.

[[Page 46806]]

    Response: Applicant should specifically point out the support for 
any amendments made to the disclosure. See e.g., MPEP Sec.  2163.06. 
Furthermore, when applicant adds a new claim limitation in an 
application that contains more than five independent claims or more 
than twenty-five total claims, applicant is required to submit a 
supplemental examination support document that includes a showing of 
where such new claim limitation finds support under 35 U.S.C. 112, ] 1, 
in the written description of the specification and in any parent 
application. In addition, the examiner may require the applicant to 
show where the specification of the application or a parent application 
provides written description support under 35 U.S.C. 112, ] 1, for a 
new limitation. See Sec.  1.105(a)(1)(ix) (as adopted in this final 
rule).
    Comment 247: One comment argued that the concise statement of 
utility and the 35 U.S.C. 112 showing required in an examination 
support document make no sense. The comment argued that cross-
referencing each line of the claims back to the specification is a 
waste of time. One comment argued that applicants should not have to 
admit what is disclosed, but rather they should only have to admit what 
is not disclosed.
    Response: In view of the comments, the Office is not adopting the 
requirement that an examination support document contain a concise 
statement of the utility of the invention as defined in each of the 
independent claims. The showing of where each limitation of the claims 
finds support under 35 U.S.C. 112, ] 1, however, would be helpful to 
the examiner. The examiner is responsible for determining whether or 
not there is 35 U.S.C. 112, ] 1, support in the written description for 
claimed subject matter. If applicant provides this information, it will 
assist the examiner in the examination of the application by making it 
easier for the examiner to make the necessary determinations. See Hyatt 
v. Dudas, 2007 U.S. App. LEXIS 15350 (Fed. Cir. Jun. 28, 2007). The 
applicant should be aware of where each limitation of the claims finds 
support under 35 U.S.C. 112, ] 1, in the written description by virtue 
of having prepared the application. There is no justification for 
requiring the examiner to duplicate this effort in an application that 
exceeds the five independent claim and twenty-five total claim 
threshold set forth in Sec.  1.75(b).
    Comment 248: One comment argued that Sec.  1.265(a)(2) through 
(a)(4) resurrects provisions that used to be in the rules, but were 
amended out of the rules in 1992 when they were found to be unworkable.
    Response: The Office proposed a number of changes to the rules of 
practice around 1990 related to the duty of disclosure and the filing 
of information disclosure statements. See Duty of Disclosure, 56 FR 
37321 (Aug. 6, 1991), 1129 Off. Gaz. Pat. Office 52 (Aug. 27, 1991) 
(proposed rule), and Duty of Disclosure and Practitioner Misconduct, 54 
FR 11334 (Mar. 17, 1989), 1101 Off. Gaz. Pat. Office 12 (Apr. 4, 1989) 
(proposed rule). The Office ultimately adopted changes to the duty of 
disclosure provisions of Sec.  1.56 and the information disclosure 
statement provisions of Sec. Sec.  1.97 and 1.98 (and deleted Sec.  
1.99) in 1992. See Duty of Disclosure, 57 FR 2021 (Jan. 17, 1992), 1135 
Off. Gaz. Pat. Office 13 (Feb. 13, 1992) (final rule). The changes 
adopted in the 1992 final rule concerning the duty of disclosure 
provisions of Sec.  1.56 and the information disclosure statement 
provisions of Sec. Sec.  1.97 and 1.98 did not eliminate, or decline to 
adopt as final, provisions similar to the provisions of Sec.  1.265(a).
    Comment 249: One comment argued that the requirement for an 
examination support document was contrary to case law (citing In re 
Wilder, 736 F.2d 1516, 222 U.S.P.Q. 369 (Fed. Cir. 1984)) that 
applicant is not under a duty to search.
    Response: Initially, it is noted that Wilder does not stand for the 
proposition that applicant does not have a duty to search. Wilder 
involved a reissue application. That case held that an attorney's 
statement that his error was a misunderstanding of the scope of the 
invention arose resulting from a lack of a prior art search was a 
sufficient explanation to satisfy the requirements of the reissue rule 
regarding how the error arose. There is some case law, however, that 
indicates that applicant does not have a duty to search. See Nordberg, 
Inc. v. Telesmith, Inc., 82 F.3d 394, 397, 38 U.S.P.Q.2d 1593, 1595-96 
(Fed. Cir. 1996); FMC Corp. v. Hennessy Indus., Inc., 836 F.2d 521, 526 
n.6, 5 U.S.P.Q.2d 1272, 1275-76 n.6 (Fed. Cir. 1987); FMC Corp. v. 
Manitowoc Co., 835 F.2d 1411, 1415, 5 U.S.P.Q.2d 1112, 1115 (Fed. Cir. 
1987); Am. Hoist & Derrick Co. v. Sowa & Sons, Inc., 725 F.2d 1350, 
1362, 220 U.S.P.Q. 763, 772 (Fed. Cir. 1984), cert. denied, 469 U.S. 
821, 224 U.S.P.Q. 520 (1984). In view of these cases, the Office has 
stated that ``[a]n applicant has no duty to conduct a prior art search 
as a prerequisite to filing an application for patent.'' See MPEP Sec.  
410. The case law, however, only discusses applicant's responsibility 
under the rules in 37 CFR Part 1 that were in effect at the time that 
was relevant to these particular cases. The case law does not stand for 
the proposition that the Office cannot change the rules in 37 CFR Part 
1 to require a preexamination search, either generally or, when an 
applicant presents more than five independent claims or more than 
twenty-five total claims in an application. Indeed, commentators have 
suggested that, especially after Festo X, a practitioner who declines 
to conduct any pre-filing search as a matter of practice may be falling 
short of the responsibility under 37 CFR part 10 to perform services 
with competence. See Schneck, The Duty to Search, 87 J.P.T.O.S. 689, 
696-701 (2005).
    Comment 250: One comment argued that an examination support 
document is not properly compared to an appeal brief since, in an 
appeal brief, the focus is on the examiner's rejection and 
interpretation of the references, whereas in an examination support 
document, applicant is required to provide a search, interpret claims, 
and identify all issues related to the search results with respect to 
each element of each claim.
    Response: The Office did not compare an examination support 
document to an appeal brief. The Office simply indicated that the 
proposed ``representative claim'' examination approach was similar to 
the BPAI's representative claim practice. Nevertheless, the Office is 
not adopting the ``representative claims'' examination approach in this 
final rule.
    Comment 251: One comment argued that the rule changes, especially 
the requirement for an examination support document, are not rationally 
related to achieving the stated goals of improving patent quality and 
increasing efficiency.
    Response: The Office is requiring an examination support document 
in those cases where applicants feel they need to have more than five 
independent claims or more than twenty-five total claims because these 
applications are the most burdensome for the Office. An examination 
support document will help the Office improve quality and increase 
efficiency because it will assist the examiner with the examination of 
the application. It should provide the examiner with the most pertinent 
prior art and an analysis of that art. Therefore, the changes being 
adopted in this final rule are related to the goals of improving 
quality and increasing efficiency.
    Comment 252: One comment argued that the examination support 
document requirement will increase demand for public searchers and this 
may drain the examining pool and worsen retention.
    Response: It is the Office's experience that only a small number of 
examiners

[[Page 46807]]

who leave the Office do so to become public searchers.
    Comment 253: One comment argued that practitioners do not draft 
patent applications to claim subject matter that they believe is not 
supported by the specification and thus it should be sufficient to 
merely assert that the claims are supported by the ``entire 
specification.''
    Response: The purpose of the requirement for a showing of where 
each limitation of the claims finds support under 35 U.S.C. 112, ] 1, 
is to assist the examiner in determining where the specification 
provides written description support for each claim limitation. An 
assertion by the practitioner that the claims are supported by the 
entire specification would not be of any assistance to the examiner.
    Comment 254: Several comments argued that an examination support 
document should not be required until after the time for issuing a 
restriction requirement has passed because it is unfair to require 
applicant to prepare and file an examination support document when 
claims may be restricted such that fewer than ten representative claims 
are pending for examination. One comment suggested that a time period 
should be set in which the examiner must issue a restriction 
requirement or indicate that there will be none, and then the time 
period for submission of an examination support document should be set 
after that.
    Response: As discussed previously, an applicant may submit a 
suggested restriction requirement accompanied by an election without 
traverse of an invention to which there are no more than five 
independent claims and no more than twenty-five total claims. See Sec.  
1.142(c) and the discussion of Sec.  1.142(c). In this situation, an 
examination support document will not be required if the suggested 
restriction requirement is accepted. An examination support document 
will be required only if the suggested restriction requirement is not 
accepted, and the application contains more than five independent 
claims or more than twenty-five total claims, or more than five 
independent claims or more than twenty-five total claims to the elected 
invention and/or species if the examiner makes a restriction 
requirement that is different from the suggested restriction 
requirement.
    Comment 255: One comment suggested that the Office should give 
assurances that: Like an information disclosure statement, nothing in 
an examination support document is an admission of prior art; nothing 
in the examination support document would be considered as affecting 
the scope of the claims; and the examination support document would not 
be published and examiners would make no references to it in 
correspondence. One comment supported the use of a limited examination 
support document that would require applicants to identify where in the 
specification the corresponding structure, material or acts for 
functional claim elements may be found since this would improve 
examination efficiency and have minimal effects in litigation.
    Response: Providing assurances that the examination support 
document would not affect the scope of the claims would not be 
appropriate. The showing of where each limitation of the claims finds 
support under 35 U.S.C. 112, ] 1, in the written description of the 
specification and the showing that includes the structure, material, or 
acts in the specification that correspond to each means-(or step-) 
plus-function claim element that invokes consideration under 35 U.S.C. 
112, ] 6, may affect the interpretation of the claims. The 
determination on patentability is made on the entire record of the 
application. In order to provide a complete application file history, 
the examiner may find that it is necessary to state on the record any 
agreement or disagreement with applicant's explanation of how the 
claims are patentable over the references or applicant's explanation of 
where each limitation of the claims finds support under 35 U.S.C. 112, 
] 1, in the written description. The application record is available to 
the public upon the publication of the application under 35 U.S.C. 
122(b) and the issuance of a patent on the application.
    Comment 256: One comment suggested that the Office require 
applicants to provide claim charts that illustrate the differences 
between claims. The comment also suggested that applicants could be 
required to identify where support exists in the specification for the 
claims, or to identify groups of claims that are similar and define 
similar limitations.
    Response: There is no prohibition against applicants submitting 
claim charts to illustrate the differences between claims. The Office 
does not consider it necessary at this time to make claim charts a 
requirement.
    Comment 257: One comment inquired why, when claims in excess of ten 
are designated, a justification for all designated claims must be 
supplied and not just the number in excess of ten representative 
claims.
    Response: The Office is not adopting the ``representative claims'' 
examination approach in this final rule. Under this final rule, 
applicant is required to file an examination support document when 
applicant presents more than five independent claims or more than 
twenty-five total claims in an application. In order to best assist in 
examination, the examination support document must cover all of the 
claims (in independent or dependent form) in the application, and not 
just the independent claims in excess of five or the total claims in 
excess of twenty-five.

I. The Office's Authority To Promulgate the Changes in This Final Rule

    Comment 258: A number of comments argued that the changes to the 
rules of practice being adopted in this final rule are beyond the 
Office's rulemaking authority under 35 U.S.C. 2(b)(2). The comments 
argued that the proposed Sec. Sec.  1.75(b), 1.78(d), and 1.78(f) are 
substantive and not procedural in nature because they affect an 
applicant's right to receive a patent for an invention or an 
applicant's ability to claim what the applicant regards as the 
invention.
    Response: The Office has the authority under 35 U.S.C. 2(b)(2) to 
establish regulations, not inconsistent with law, which shall govern 
the conduct of proceedings in the Office. The ``conduct of proceedings 
in the Office'' provision of 35 U.S.C. 2(b)(2) (as well as former 35 
U.S.C. 6(a)), however, is not limited to what might be characterized as 
``procedural'' rather than ``substantive'' rules. See United States v. 
Haggar Apparel Co., 526 U.S. 380, 387-88 (1999). Simply contending that 
a regulation is ``substantive and not procedural'' fails to address the 
issue because a regulation that relates to application processing 
within the Office and that is not inconsistent with law falls within 
the Office's rulemaking authority. See In re Van Ornum, 686 F.2d 937, 
945, 214 U.S.P.Q.2d 761, 768 (C.C.P.A. 1982) (``Appellants say the 
regulation is `invalid on its face' but they do not explain why beyond 
contending it is `substantive and not procedural.' We can give no 
weight to that contention. True, the rule is substantive in that it 
relates to a condition under which a patent will be granted which 
otherwise would have to be denied for double patenting. Much of the 
content of the PTO rules is `substantive' in this respect. The 
regulation clearly relates to application processing within the PTO in 
a manner consistent with statutory and case law, which is its principal 
business.'').
    The regulations at issue in this final rule concern application 
processing

[[Page 46808]]

exclusively within the Office. The changes to Sec.  1.75 being adopted 
in this final rule govern the requirements relating to the examination 
of the claims in an application, as is provided for in 35 U.S.C. 131. 
The changes to Sec.  1.78(d) being adopted in this final rule govern 
the conditions under which an application may contain or be amended to 
contain a claim under 35 U.S.C. 120, 121, or 365(c) to the benefit of a 
prior-filed application. The changes to Sec.  1.78(f) being adopted in 
this final rule govern the requirements relating to the filing and 
examination of multiple applications by a common owner. The filing of 
an application for patent, amendment of an application, and the 
examination of an application are proceedings that take place 
exclusively within the Office. Therefore, regulations governing 
requirements relating to the filing, amendment, and examination of an 
application fall squarely within the Office's authority under 35 U.S.C. 
2(b)(2) to establish regulations which ``govern the conduct of 
proceedings in the Office.''
    The substantive right at issue during the patent examination 
process involves whether the applicant has met the conditions and 
requirements under title 35, United States Code, to be entitled to a 
patent, rather than the ability to file and maintain an unlimited 
number of continuing applications or requests for continued examination 
or the ability to refrain from obtaining and providing information 
pertinent to the examination of the application to the Office. See, 
e.g., 35 U.S.C. 101 (``[w]hoever invents or discovers any new and 
useful process, machine, manufacture, or composition of matter, or any 
new and useful improvement thereof, may obtain a patent therefor, 
subject to the conditions and requirements of this title''). The 
changes in this final rule do not preclude applicants from obtaining a 
patent on an invention, discourage, impede, or block an applicant's 
statutory right to a patent, or stifle inventors' rights to protect 
their inventions.
    The changes to continuing application practice adopted in this 
final rule do not set a per se limit on the number of continuing 
applications that an applicant may file. That is, applicant may 
automatically file a first and second continuation application without 
any justification and may file any number of additional continuation 
applications as long as he or she justifies each filing by a showing as 
to why the amendment, argument or evidence sought to be entered could 
not have been previously presented. Therefore, the changes to the final 
rule do not affect an applicant's right to receive a patent for an 
invention. The modification to continuation practice simply improves 
the procedures under which an applicant may file a continuation 
application by focusing and consolidating the examination process. 
Furthermore, as an alternative, an applicant may choose to file an 
appeal when confronted with a rejection that he or she feels is 
improper. The changes adopted in this final rule to the continuing 
application practice prevent applicants from unnecessarily prolonging 
prosecution of applications before the Office.
    The changes to the examination of claims practice adopted in this 
final rule do not prevent an applicant from presenting as many claims 
as are considered necessary or desirable to protect the full scope of 
the invention. The changes to the examination of claims practice 
adopted in this final rule simply provide that if an applicant exceeds 
or contemplates exceeding a specified threshold (five independent 
claims or twenty-five total claims), the applicant can provide for that 
eventuality by submitting additional information to the Office in an 
examination support document in order to facilitate effective 
examination of the application. The submission of an examination 
support document does not change the substantive criteria applied 
during examination (i.e., the statutory standards of patentability set 
forth in title 35, United States Code) to determine the applicant's 
entitlement to a patent.
    The patentably indistinct claims provisions do not affect 
applicant's patent rights because once the required explanation of 
patentable indistinctness has been provided, the claimed invention is 
examined on the merits and patentability is determined by the Office. 
The requirement that applicant show that claims are patentably distinct 
up front is simply a tool to focus and consolidate the examination of 
multiple applications.
    Comment 259: A number of comments suggested that a requirement of a 
showing to obtain an additional continuation application is contrary to 
35 U.S.C. 120, 121, 365, 132(b), and other sections of title 35, United 
States Code, under which an applicant has a right to file an unlimited 
number of continuation applications. The comments suggested that: (1) 
The proposed rules disregard case law, in particular, In re Hogan, 559 
F.2d 595, 194 U.S.P.Q. 527 (C.C.P.A. 1977), and In re Henriksen, 399 
F.2d 253, 158 U.S.P.Q. 224 (C.C.P.A. 1968); (2) the Office does not 
have authority to limit the number of continuing applications under 35 
U.S.C. 2(b)(2) because the proposed rules are inconsistent with the 
law, and specifically do not ``facilitate and expedite the processing 
of patent applications''; (3) the changes to Sec.  1.78 cut off 
substantive rights for reasons other than patentability (as set forth 
in 35 U.S.C. 102, 103 and 112 of title 35, United States Code) and 
procedural misconduct, and thus are in violation of 35 U.S.C. 131; (4) 
the changes to Sec.  1.78 are inconsistent with 35 U.S.C. 131 or 132, 
because the Director does not have the statutory discretion under these 
provisions to refuse to examine or to reexamine any application; (5) 
the requirement for a ``showing'' is contrary to law because the Office 
has no authority to deny an applicant the right to file a continuation 
application or a request for continued examination; (6) no 
justification or legal basis exists for the petition requirements set 
forth in the rules to get the benefit of an earlier filing date under 
35 U.S.C. 120 or 365; (7) the Office has no statutory authority to 
delete a claim to priority in a continuing application filed according 
to the statutory provisions; and (8) applicants have a right to file a 
continuation application, as long as the reason is not improper, unduly 
successive or repetitive, citing Godfrey v. Eames, 68 U.S. (1 Wall.) 
317, 325-26 (1864). Other comments, however, suggested that the 
proposed rules are consistent with both statute and case law given 
that: (1) The Office is not instituting a per se numerical limit on the 
number of continuation applications that an applicant may file; and (2) 
applicants are afforded an opportunity to justify by a showing the need 
to file additional continuation applications.
    Response: None of the statutory provisions or case law cited by the 
comments provides that an applicant may file an unlimited number of 
continuing applications or requests for continued examination.
    None of the statutory provisions related to continuing applications 
cited by the comment provide that an applicant may file an unlimited 
number of continuing applications. 35 U.S.C. 120 simply provides that 
an applicant may claim the benefit of the filing date of a prior-filed 
application provided that certain conditions are satisfied. 35 U.S.C. 
121 provides that if the Director requires that an application 
containing claims to two or more independent and distinct inventions be 
restricted to one of the inventions and a non-elected invention is made 
the subject of a divisional application, the applicant in the 
divisional application may claim the benefit of the filing date of 
prior-filed

[[Page 46809]]

application provided that the conditions specified in 35 U.S.C. 120 are 
satisfied. 35 U.S.C. 365(c) provides that an applicant in an 
international application designating the United States may claim the 
benefit of the filing date of a prior-filed national application or a 
prior-filed international application designating the United States, 
and that an applicant in a national application may claim the benefit 
of the filing date of a prior-filed international application 
designating the United States, again provided that the conditions 
specified in 35 U.S.C. 120 are satisfied.
    Since 35 U.S.C. 120, 121 and 365(c) all hinge upon 35 U.S.C. 120, 
the response focuses on that provision. 35 U.S.C. 120 provides that:

    An application for patent for an invention disclosed in the 
manner provided by the first paragraph of section 112 of this title 
in an application previously filed in the United States, or as 
provided by section 363 of this title, which is filed by an inventor 
or inventors named in the previously filed application shall have 
the same effect, as to such invention, as though filed on the date 
of the prior application, if filed before the patenting or 
abandonment of or termination of proceedings on the first 
application or on an application similarly entitled to the benefit 
of the filing date of the first application and if it contains or is 
amended to contain a specific reference to the earlier filed 
application. No application shall be entitled to the benefit of an 
earlier filed application under this section unless an amendment 
containing the specific reference to the earlier filed application 
is submitted at such time during the pendency of the application as 
required by the Director. The Director may consider the failure to 
submit such an amendment within that time period as a waiver of any 
benefit under this section. The Director may establish procedures, 
including the payment of a surcharge, to accept an unintentionally 
delayed submission of an amendment under this section.

35 U.S.C. 120 (2000).

    35 U.S.C. 120 has been revised significantly since its codification 
as part of the 1952 Patent Act. 35 U.S.C. 120 as codified in the 1952 
Patent Act provided that: ``[a]n application for patent for an 
invention disclosed in the manner provided by the first paragraph of 
section 112 of this title in an application previously filed in the 
United States by the same inventor shall have the same effect, as to 
such invention, as though filed on the date of the prior application, 
if filed before the patenting or abandonment of or termination of 
proceedings on the first application or on an application similarly 
entitled to the benefit of the filing date of the first application and 
if it contains or is amended to contain a specific reference to the 
earlier filed application.'' 35 U.S.C. 120 (1952). 35 U.S.C. 120 was 
amended in 1975 to add ``or as provided by section 363 of this title'' 
to provide for claims under 35 U.S.C. 120 to the benefit of an 
international application filed under the PCT (i.e., international 
applications filed under 35 U.S.C. 363). Pub. L. 94-131, section 9, 89 
Stat. 685, 692 (1975). 35 U.S.C. 120 was amended again in 1984 to 
substitute ``by an inventor or inventors named in the previously filed 
application'' for ``by the same inventor'' for consistency with the 
changes to the inventorship provisions of 35 U.S.C. 116. Public Law 98-
622, section 104(b), 98 Stat. 3383, 3385 (1984). 35 U.S.C. 120 was 
finally amended in 1999 to give the Director greater authority with 
respect to setting forth the time period within which claims to the 
benefit of a prior-filed application must be submitted by adding:

    No application shall be entitled to the benefit of an earlier 
filed application under this section unless an amendment containing 
the specific reference to the earlier filed application is submitted 
at such time during the pendency of the application as required by 
the Director. The Director may consider the failure to submit such 
an amendment within that time period as a waiver of any benefit 
under this section. The Director may establish procedures, including 
the payment of a surcharge, to accept an unintentionally delayed 
submission of an amendment under this section.

Public Law 106-113, 113 Stat. 1501, 1501A-563 through 1501A-564 (1999). 
Thus, 35 U.S.C. 120 has never contained any language either expressly 
or implicitly stating that an applicant may file an unlimited number of 
continuing applications.

    Turning to the legislative history of the 1952 Patent Act, it does 
not mention whether an applicant may file an unlimited number of 
continuing applications. The Senate Report simply documents that 
``[s]ections 120 and 121 express in the statute certain matters which 
exist in the law today but which had not before been written into the 
statute, and in so doing make some minor changes in concepts 
involved.'' S. Rep. No. 1979, at 2400 (June 27, 1952). The House Report 
contains basically the same description for 35 U.S.C. 120. The 
testimony from hearings before a Subcommittee of the Committee on the 
Judiciary, House of Representatives, for the 82nd Congress, held on 
June 13, 14, and 15, 1951, contains the same description for 35 U.S.C. 
120 and little else of substance. For example, P.J. Federico testified: 
``Sections 120 and 121 express in the statute certain things which 
exist in the law today that have not been written into the statute, and 
in so doing make some changes in the concepts involved.'' Patent Law 
Codification and Revision, 82d Cong. 39 (June 13, 1951) (statement of 
P.J. Federico, Examiner-In-Chief, United States Patent Office). 
Additionally, as noted in the congressional record for the 1952 Patent 
Act, 35 U.S.C. 120 codified existing patent practice. 98 Cong. Rec. 7, 
9323 (June 28, 1952 to July 7, 1952) (statements of Senators 
Saltonstall and McCarran). In particular, ``[t]he provisions set out in 
section 120 giving the applicant the benefit of the date of an earlier 
application by him for the same invention constitute a restatement of 
the former practice which was not, however, spelled out in the former 
law.'' Charles L. Zinn, Commentary on New Title 35, U.S. Code 
``Patents'' 2515.
    Secondary sources providing information about 35 U.S.C. 120 also do 
not offer guidance with respect to whether an applicant may file an 
unlimited number of continuing applications. The 1952 Patent Act was 
drafted by: (1) P.J. Federico, Examiner-In-Chief of the Patent Office; 
(2) Giles S. Rich, then an attorney of some twenty years representing 
the National Council of Patent Law Associations; (3) Paul Rose, 
chairman of the laws and rules committee of the American Patent Law 
Association; and (4) Henry Ashton, a representative of the coordinating 
committee on revision and amendment of the patent laws of the National 
Council of Patent Law Associations. See generally, Giles S. Rich, 
Congressional Intent--Or, Who Wrote the Patent Act of 1952, Patent 
Procurement and Exploitation (BNA 1963), reprinted in Nonobviousness--
The Ultimate Condition of Patentability (John F. Witherspoon ed., 1983) 
(hereinafter ``Rich on Congressional Intent''). Following enactment, 
Federico gave a series of lectures to teach the patent bar about the 
new law. Federico's lectures were transcribed, consolidated, and 
reprinted for many years in title 35, United States Code Annotated. See 
35 U.S.C.A. sections 1 to 110 (1954). The Federal Circuit has 
considered Federico's Commentary to be ``an invaluable insight into the 
intentions of the drafters of the Act.'' Symbol I, 277 F.3d at 1366, 61 
U.S.P.Q.2d at 1519.
    Federico explained that 35 U.S.C. 120 was ``not specified in the 
old statute but was developed by decisions of the courts beginning with 
a decision of the Supreme Court of 1864, Godfrey v. Eames.'' P.J. 
Federico, Commentary on the New Patent Act, 75 J. Pat. & Trademark Off. 
Soc'y 3, 192 (Mar. 1993) (hereinafter ``Federico's Commentary''). After 
offering this opening statement, he then set forth the three 
requirements for

[[Page 46810]]

a continuation application required by 35 U.S.C. 120 and elaborated on 
the meaning of each of these three requirements.
    Although Federico's Commentary did not expressly mention any limits 
or conditions on an applicant's ability to file a continuation, it also 
did not state that the drafters contemplated allowing an applicant to 
file an unlimited number of continuation applications. Thus, there is 
nothing which indicates that the drafters intended to permit an 
applicant to file an unlimited number of continuing applications. What 
is more, Federico described examples of situations where continuations 
were used before the codification of the 1952 Patent Act:

    Continuing applications are utilized in a number of different 
situations; for example, in the case of a requirement to restrict an 
application to a single invention a second application might be 
filed for the invention excluded from the the [sic] first 
application as explained in connection with the next section of the 
law, or a second application might be filed for a separable 
invention even though no requirement was made. A continuing 
application with the disclosure the same as a first application 
might sometimes be filed for procedural reasons with the first 
application thereafter being abandoned. And a continuing application 
with added subject matter may sometimes be filed when the inventor 
has additional details relating to the invention which he wishes to 
disclose in the application; in such cases the second application 
would be entitled to the date of the first application only as to 
the common subject matter.

Federico's Commentary, 5 J. Pat. & Trademark Soc'y at 194.

    Federico's list, albeit not exhaustive, suggests that patent 
practitioners used continuing applications in more limited 
circumstances before the 1952 Patent Act than today. His first example 
focuses on the divisional-type situation where a continuing 
(divisional) application is pursued to protect a second invention as a 
result of a restriction in the initial application. His third example 
focuses on a continuation-in-part situation where a continuing 
application is filed to enable an applicant to add subject matter to 
the application. Only his second example contemplates anything like 
current continuation practice where a continuing application is filed 
to pursue protection for an invention disclosed in the initial 
application. Federico nevertheless explained that the first application 
to which the continuing application claims priority is abandoned after 
the continuation is filed.
    Federico did not include the then-rare situation in which the first 
application issued as a patent and the continuing application was filed 
to pursue further protection for the invention of the patent on the 
first application. At the time of the 1952 Patent Act the double 
patenting doctrine did not permit a patentee to obtain more than one 
patent on patentably indistinct subject matter. See e.g., Miller v. 
Eagle Mfg. Co., 151 U.S. 186, 199 (1894) (the ``a patent'' for an 
invention provision does not permit a patentee to obtain more than one 
patent on patentably indistinct subject matter). Even after the 1952 
Patent Act, the double patenting provision of 35 U.S.C. 101 (``a 
patent'' for an invention), like its predecessor, was interpreted as 
precluding a patentee from obtaining more than one patent on patentably 
indistinct subject matter. See, e.g., In re Ockert, 245 F.2d 467, 469, 
114 U.S.P.Q. 330, 332 (C.C.P.A. 1957)). It was not until 1970 that the 
Court of Customs and Patent Appeals held that the double patenting 
provision of 35 U.S.C. 101 precluded only ``same invention'' double 
patenting (i.e., two patents containing claims to identical subject 
matter) and permitted the use of a terminal disclaimer to overcome 
double patenting unless the application and patent were claiming 
identical subject matter. See In re Vogel, 422 F.2d 438, 441, 164 
U.S.P.Q. 617, 622 (C.C.P.A. 1970). Thus, applicants today frequently do 
not abandon the initial application, but instead prosecute the initial 
application in parallel with the continuation application. Because of 
the development of terminal disclaimer practice, the authors of the 
1952 Patent Act would not have contemplated a continuing application 
system under which an applicant would file an unlimited number of 
continuing applications.
    Moreover, both before and long after the 1952 Patent Act applicants 
did not file long strings of continuation applications as is often done 
today. Indeed, the Board of Patent Appeals (Board) in Henriksen 
attempted to identify cases involving a series of more than three 
patents from cases litigated in the courts and patents issued by the 
Office during the week of April 26, 1966. Ex parte Henriksen, 154 
U.S.P.Q. 53, 58-59 (Pat. Off. Bd. App. 1966). The Board in Henriksen 
was unable to isolate a single case involving a priority chain longer 
than three applications, with one exception that the Board nevertheless 
dismissed because the case was quite old, dating to 1867, and because 
the factual record was developed under different law. Id. at 58, n.2 
(referring to the case as ``an antique curiosity''). Based on the 
Board's research, it appears that priority chains having more than 
three family members were actually uncommon, if they existed at all, 
before the 1952 Patent Act. Thus, if anything, the drafters of the Act, 
seeking to codify existing practice, did not envision that an applicant 
would use the provisions of 35 U.S.C. 120 to file and maintain an 
unlimited number of continuing applications.
    Following the enactment of the 1952 Patent Act, case law has 
specifically addressed the imposition of limits or conditions on 
continuation practice in the two cases cited by the comments (Henriksen 
and Hogan). In Henriksen and Hogan, the Court of Customs and Patents 
Appeals (C.C.P.A.) overturned rulings by the Board denying an 
applicant's priority claim to earlier--filed applications. In Hogan, 
the Board sought--without prior warning--to limit the number of 
continuations by restricting the applicant from claiming priority where 
the continuation applications covered a pendency period of twenty-four 
years. In Henriksen, the Board took the position that 35 U.S.C. 120 
imposed a per se limit on the number of permissible continuations.
    The changes adopted in this final rule, however, do not set a limit 
on the applicant's ability to claim the benefit of a prior-filed 
application regardless of the pendency period, nor do they set a per se 
limit on the number of continuing applications that an applicant may 
file. See Changes to Practice for Continuing Applications, Requests for 
Continued Examination Practice, and Applications Containing Patentably 
Indistinct Claims, 71 FR at 50, 1302 Off. Gaz. Pat. Office at 1320 
(``No limit is placed on the number of continuing applications.''). 
Applicant may automatically file a first and second continuation 
application and further extend examination by filing a request for 
continued examination. After these options are exhausted an applicant 
may also file any number of third and subsequent continuation 
applications as long as the applicant justifies each filing by a 
showing that amendment, argument, or evidence sought to be entered 
could not have been presented earlier. The Henriksen court objected to 
the approach taken by the Board in changing continuing application 
practice retroactively. The Henriksen court objected to the Board 
changing the interpretation of the provisions of 35 U.S.C. 120 and 
applying that interpretation to previously filed applications. The 
Henriksen court specifically stated that:

    The action of the board is akin to a retroactive rule change 
which may have the effect of divesting applicants of valuable rights 
to which, but for the change in Patent

[[Page 46811]]

Office position brought about by the board's decision, they were 
entitled. Nothing appears in the Patent Office Rules of Practice or 
the Manual of Patent Examining Procedure which sanction such a 
result.

Henriksen, at 399 F.2d at 261-62, 158 U.S.P.Q. at 231. In Henriksen and 
Hogan, the Office had not promulgated any rules, let alone given the 
public notice of, or an opportunity to respond to, the ad hoc limits 
imposed. By contrast, the Office here is pursuing prospective rule 
making, having given the public notice of the changes to Sec.  1.78 and 
an opportunity to comment.

    Although the Court of Customs and Patent Appeals in a ``post 
script'' mentioned congressional resolution to remedy the abuses 
associated with continuation applications in both Henriksen and Hogan, 
the court seemed more concerned with the openness of the process for 
effecting change. Henriksen, 399 F.2d at 262, 158 U.S.P.Q. at 231. 
Here, the Office is adopting the prospective and open process missing 
in Hogan and Henriksen. The Office has given the public the opportunity 
to participate in shaping the rules for continuing application 
practice, received hundreds of comments, and has modified the proposed 
rules in response to those public comments.
    More recent case law demonstrates that an applicant does not have 
the right to file an endless stream of continuing applications. See 
Symbol I, supra, In re Bogese II, 303 F.3d 1362, 64 U.S.P.Q.2d 1448 
(Fed. Cir. 2002), and Symbol Techs. v. Lemelson Medical, Educ. & 
Research Found., 277 F.3d 1361, 61 U.S.P.Q.2d 1515 (Fed. Cir. 2002) 
(Symbol II). Symbol II, Bogese II and Symbol I suggest that the Office 
has the authority to place reasonable restrictions and requirements on 
the filing of continuing applications, just as it can place reasonable 
restrictions and requirements on the prosecution of those applications. 
In addition, the court in Bogese II expressly rejected the view that 
its previous case law (e.g., Henriksen) stood for the broad proposition 
that 35 U.S.C. 120 gave applicants carte blanche to prosecute 
continuing applications in any desired manner. Rather, it held that, 
while the statute itself provided no limit on the number of 
applications that may be co-pending, ``[n]owhere does [the prior case 
law] suggest or imply that the PTO must allow dilatory tactics or that 
the PTO lacks inherent power to prohibit unreasonable delay in 
prosecution.'' Bogese II, 303 F.3d at 1368 n.6, 64 U.S.P.Q.2d at 1452 
n.6.
    By amending the procedures under which an applicant may file 
continuation applications, the Office is seeking to encourage the 
prompt presentation of amendment, argument and evidence in patent 
prosecution. To do so, the Office has determined that it must, at some 
point, change the continuing application practice that has facilitated 
the past dilatory presentation of amendment, argument and evidence that 
could have been presented earlier. The changes adopted in this final 
rule allow an applicant the flexibility to choose between filing a 
continuing application and filing an appeal, but do not permit an 
applicant to persist indefinitely before the examiner rather than seek 
an appeal. Therefore, this final rule does not preclude an applicant 
from obtaining a patent on an invention when requirements of title 35, 
United States Code, are satisfied. As explained in the Continuing 
Applications Proposed Rule, the changes to Sec.  1.78 will ``make the 
exchange between examiners and applicants more efficient, get claims to 
issue faster, and improve the quality of issued patents.'' See Changes 
to Practice for Continuing Applications, Requests for Continued 
Examination Practice, and Applications Containing Patentably Indistinct 
Claims, 71 FR at 50, 1302 Off. Gaz. Pat. Office at 1320.
    Like the statutory provisions for continuing applications, the 
statutory provision for requests for continued examination, namely, 35 
U.S.C. 132(b), does not provide that an applicant may file an unlimited 
number of requests for continued examination. As discussed previously, 
the provisions of 35 U.S.C. 132(b) were added relatively recently by 
section 4403 of the AIPA. See Public Law 106-113, 113 Stat. 1501, 
1501A-560 (1999). 35 U.S.C. 132(b) provides that:

    The Director shall prescribe regulations to provide for the 
continued examination of applications for patent at the request of 
the applicant. The Director may establish appropriate fees for such 
continued examination and shall provide a 50 percent reduction in 
such fees for small entities that qualify for reduced fees under 
section 41(h)(1) of this title.

35 U.S.C. 132(b) (2000). The Office first implemented the provisions of 
35 U.S.C. 132(b) by a final rule in August of 2000 that was preceded by 
an interim rule in March of 2000. See Request for Continued Examination 
Practice and Changes to Provisional Application Practice, 65 FR 50092 
(Aug. 16, 2000), 1238 Off. Gaz. Pat. Office 13 (Sept. 5, 2000) (final 
rule), Changes to Application Examination and Provisional Application 
Practice, 65 FR 14865 (Mar. 20, 2000), 1233 Off. Gaz. Pat. Office 47 
(Apr. 11, 2000) (interim rule).
    The AIPA is title IV of the Intellectual Property and 
Communications Omnibus Reform Act of 1999 (S. 1948), and was 
incorporated and enacted into law as part of Public Law 106-113. The 
Conference Report for H.R. 3194, 106th Cong., 1st. Sess. (1999), which 
resulted in Public Law 106-113, does not contain any discussion (other 
than the incorporated language) of S. 1948. See H.R. Conf. Rep. No. 
106-497, at 37 and 1089-174 (1999). A section-by-section analysis of S. 
1948, however, was printed in the Congressional Record at the request 
of Senator Lott. See 145 Cong. Rec. S14,708-26 (1999) (daily ed. Nov. 
17, 1999). This section-by-section analysis of S. 1984 provides with 
respect to 35 U.S.C. 132(b) that:

    Section 4403 amends section 132 of the Patent Act to permit an 
applicant to request that an examiner continue the examination of an 
application following a notice of ``final'' rejection by the 
examiner. New section 132(a) authorizes the Director to prescribe 
regulations for the continued examination of an application 
notwithstanding a final rejection. The Director may also establish 
appropriate fees for continued examination proceedings, and shall 
provide a 50% fee reduction for small entities which qualify for 
such treatment under section 41(h)(1) of the Patent Act.

145 Cong. Rec. S14,718.

    35 U.S.C. 132(b) does not specify the conditions and requirements 
for continued examination under 35 U.S.C. 132(b), but rather authorizes 
the Director to ``prescribe regulations to provide for the continued 
examination of applications for patent at the request of the 
applicant.'' See 35 U.S.C. 132(b). There is nothing in 35 U.S.C. 132(b) 
that precludes the Office from promulgating regulations that provide 
for no more than a single request for continued examination under 35 
U.S.C. 132(b), or precludes the Office from requiring that any request 
for continued examination under 35 U.S.C. 132(b) include a showing as 
to why the amendment, argument or evidence could not have been 
previously presented.
    Comment 260: A number of comments expressed the opinion that any 
limitation on continuations should be done legislatively by 
congressional action and not by the Office via rule making. Some 
comments argued that the Office is usurping the legislative role of 
Congress by modifying continuation practice via regulation, arguing 
Congress by inaction tacitly endorses the current practice, and that 
the Federal Circuit has acknowledged that limiting continuation 
practice is an issue best left to Congress, citing Ricoh Co., Ltd. v.

[[Page 46812]]

Nashua, 185 F.3d 884 (Fed. Cir. 1999) (nonprecedential decision). Some 
comments suggested that the Office should not adopt sweeping changes 
unless and until Congress acts to address the issues through the 
pending patent reform legislation, which would ensure consistency with 
previous legislative acts. Some comments argued that questions 
regarding the Office's statutory authority to make the proposed changes 
would likely lead to litigation and a period of uncertainty until the 
matter can be resolved either judicially or legislatively. Several 
comments also suggested that the proposed changes to continuation 
practice will ultimately result in an even larger backlog at the Office 
should the Federal Circuit hold the proposed changes to be contrary to 
law, arguing that applicants in the meantime are left in a state of 
limbo until the courts finally resolve the matter. One comment argued 
that the Office's stated rationale regarding the public notice function 
of claims is not consistent with the law and is more appropriately 
addressed by Congress or the courts. Two comments also suggested that 
rules limiting the number of continuing applications are 
unconstitutional because they exceed the rule making authority of the 
Office, thereby suggesting that the Office should have sought these 
changes via legislation, not rule making.
    Response: The Office is not usurping the legislative role of 
Congress, but instead acting consistently with the authority given to 
the Office by Congress. Pursuant to 35 U.S.C. 2(b)(2)(A), Congress has 
given the Office the authority to establish regulations that ``govern 
the conduct of proceedings in the Office.'' By the grant of authority 
in 35 U.S.C. 2(b)(2)(A), ``Congress [is understood] to have `delegated 
plenary authority over PTO practice' * * * to the Office.'' Stevens v. 
Tamai, 366 F.3d 1325, 1333, 70 U.S.P.Q.2d 1765, 1771 (Fed. Cir. 2004) 
(quoting Gerritsen v. Shirai, 979 F.2d 1524, 1527 n.3, 24 U.S.P.Q.2d 
1912, 1915 n.3 (Fed. Cir. 1992)). Therefore, the decision to make these 
changes via rule making is not an unconstitutional exercise of the 
Office's rule making authority under 35 U.S.C. 2(b)(2).
    Additionally, the provisions of Sec.  1.78, which concern 
continuing applications, govern proceedings in the Office because they 
set forth the process by which an applicant can file a continuing 
application. See Changes to Practice for Continuing Applications, 
Requests for Continued Examination Practice, and Applications 
Containing Patentably Indistinct Claims, 71 FR at 50, 1302 Off. Gaz. 
Pat. Office at 1320 (noting that continuation practice is ``a 
procedural device that permits an applicant to amend his application 
after rejection and receive examination of the `amended' (or new) 
application'') (citing In re Bogese I, 22 U.S.P.Q. 2d at 1824). 
Specifically, under revised Sec.  1.78, an applicant may automatically 
file a first and second continuing application and then may file any 
number of third and subsequent continuing applications as long as the 
applicant justifies each filing by a showing as to why the amendment, 
argument or evidence sought to be entered could not have been 
previously presented. Furthermore, as an alternative, an applicant may 
choose to file an appeal when confronted with a rejection that he or 
she feels is improper. The changes adopted in this final rule do not 
impede or block an applicant's statutory right to a patent.
    The Office is responsible for the granting and issuing of patents 
and has the authority and responsibility to establish regulations that 
govern the conduct of proceedings in the Office and facilitate and 
expedite the processing of patent applications. See 35 U.S.C. 2(a)(1) 
and (b)(2). The Office has the responsibility to take appropriate 
action in the near term to improve patent quality and pendency issues 
rather than wait for possible legislative solutions to these issues. 
The Office is implementing the rule changes via the rule making 
procedures set forth in 35 U.S.C. 2(b)(2)(A) and 5 U.S.C. 553 by 
publishing the proposed rules in the Federal Register and giving the 
public the opportunity for comment. Thus, the Office is acting under 
the broad rule making authority delegated to it by Congress. Were the 
Office to sit idle and not set forth procedures to govern a continuing 
application practice that has become problematic, the Office would be 
ignoring the responsibility imposed on it by Congress in 35 U.S.C. 
2(b)(2)(A). Finally, inaction by Congress is not a tacit endorsement of 
the current continuing application practice (see United States v. 
Price, 361 U.S. 304, 310-11 (1960) (``nonaction by Congress affords the 
most dubious foundation for drawing positive inferences'')), and the 
Federal Circuit has cautioned against reliance upon nonprecedential 
decisions such as Ricoh Co., Ltd. v. Nashua (see Symbol I, 277 F.3d at 
1368, 61 U.S.P.Q.2d at 1520, declining to consider the nonprecedential 
opinions Ricoh Co., Ltd. v. Nashua and Bott v. Four Star Corp., 848 
F.2d 1245 (Fed. Cir. 1988)).
    Comment 261: A few comments suggested that patent reform 
legislation indicates that the Office does not have the authority to 
limit the number of continuing applications, citing The Patent Reform 
Act of 2005, H.R. 2795, 109th Cong. Sec.  8 (2005). One comment 
specifically suggested that Congress' decision to remove authority to 
limit continuations from later patent reform legislation indicates that 
Congress is still debating the issue and that the Office does not have 
that authority. One comment suggested that Congress' intent is not to 
limit the number of applications that an applicant may file or the 
number of inventive concepts that an application may pursue, because 
that would stifle inventors' rights to protect their inventions.
    Response: The Office notes that legislation was pending before the 
109th Congress (The Patent Reform Act of 2005) which, as introduced on 
June 8, 2005, contained a provision (section 8) that expressly 
authorized the Office to limit certain continuing applications. The 
Office also notes that the House Subcommittee on Courts, the Internet, 
and Intellectual Property held a hearing on September 15, 2005, on a 
proposed substitute that did not contain such a provision. No further 
action, however, was taken on this legislation by the 109th Congress. 
The Office does not consider this course of events as constituting any 
evidence of ``congressional intent'' because the legislation at issue 
(The Patent Reform Act of 2005) was not voted on by either House of 
Congress, or even a Committee or Subcommittee of either House of 
Congress. Thus, this change between the legislation as introduced and 
as amended is at most evidence of the intent of a drafting committee. 
In any event, the 109th Congress did not enact changes to the 
provisions of 35 U.S.C. 2(b), 120, 121, 131, 132, or 365. Rather, the 
provisions at issue were enacted by earlier Congresses. The views of a 
subsequent Congress have little relevance in determining the intent of 
an earlier Congress. See United States v. Southwestern Cable Co., 392 
U.S. 157, 170 (1968) (``The views of one Congress as to the 
construction of a statute adopted many years before by another Congress 
have very little, if any, significance.''). This is especially true 
when the gap is as broad as the one here, spanning more than half a 
century (i.e., 1952-2005).
    Furthermore, this final rule does not stifle inventors' rights 
because it provides inventors with ample opportunity to present their 
claims and secure protection for their inventions. In fact, this final 
rule encourages inventors to fully disclose and fully claim their 
inventions promptly, on first filing. Applicants may file two 
continuation or continuation-in-part applications and a

[[Page 46813]]

request for continued examination in an application family, without any 
justification and may file additional continuing applications or 
requests for continued examination on a showing that the amendment, 
evidence or argument could not have been earlier presented. Finally, 
this final rule does not affect the patentability requirement of title 
35, United States Code.
    Comment 262: A few comments asserted that the doctrine of 
prosecution laches, originally set forth by the Federal Circuit in 
Bogese II, and more recently endorsed by the Federal Circuit in Symbol 
II, does not extend the Office's authority to deny benefit claims to 
legitimate continuing applications.
    Response: The Office is not using the doctrine of prosecution 
laches as a sword to sever an applicant's priority claim. Nor are the 
changes adopted in this final rule an attempt to codify Bogese II or to 
combat extreme cases of prosecution laches. See Changes to Practice for 
Continuing Applications, Requests for Continued Examination Practice, 
and Applications Containing Patentably Indistinct Claims, 71 FR at 50, 
1302 Off. Gaz. Pat. Office at 1320. Applicants and practitioners have a 
duty to refrain from submitting an application or other filing to cause 
unnecessary delay or needless increase in the cost of prosecution 
before the Office. See Sec.  10.18(b)(2). Applicants also have a duty 
throughout prosecution of an application for patent to make a bona fide 
attempt to advance the application. See Changes to Practice for 
Continuing Applications, Requests for Continued Examination Practice, 
and Applications Containing Patentably Indistinct Claims, 71 FR at 49, 
1302 Off. Gaz. Pat. Office at 1319. In Symbol I, Symbol II, and Bogese 
II, the Federal Circuit recognized that an applicant has a duty of good 
faith in advancing the prosecution of an application. The Federal 
Circuit likewise held that an applicant does not have the right to file 
an endless stream of continuing applications in order to prolong 
prosecution for the purpose of gaming the system. That is, applicants 
should not rely on an unlimited number of continuing applications to 
either correct deficiencies in the claims and disclosure, or to delay 
the conclusion of examination in a calculated manner. By requiring 
applicants to show why the amendment, argument, or evidence sought to 
be entered in a third or subsequent continuing application or second or 
subsequent request for continued examination could not have been 
presented earlier, the Office is ensuring that applicants are not 
unnecessarily prolonging prosecution of the application before the 
Office.
    The possibility that, without justification, a string of continuing 
applications could last as long as two decades has created 
inefficiencies and opportunities for the delay of proceedings before 
the Office that, as a practical matter, can only be addressed by 
general rule making. Requiring that, at a given stage in the continuing 
application process, an applicant must make an affirmative showing of 
need is necessary for the Office to assure an effective examination 
process. Relying only on a case-by-case approach to address the most 
egregious cases of abuse would not be sufficient when continued 
examination filings (other than divisional applications) have grown 
from less than twelve percent of total filings in 1980 to over twenty-
nine percent of total filings in fiscal year 2006. The Federal Circuit 
specifically indicated in Bogese II that the Office has the inherent 
authority to set reasonable deadlines and requirements for the 
prosecution of patent applications. See Bogese II, 303 F.3d at 1368 
n.6, 64 U.S.P.Q.2d at 1452 n.6 (``The PTO is the administrative agency 
that is `responsible for the granting and issuing of patents * * *' 5 
U.S.C. 2 (2000). Like other administrative agencies, the PTO may impose 
reasonable deadlines and requirements on parties that appear before it. 
The PTO has inherent authority to govern procedure before the PTO, and 
that authority allows it to set reasonable deadlines and requirements 
for the prosecution of applications.''). Thus, consistent with the 
Office's inherent authority to set reasonable deadlines and 
requirements for the prosecution of applications, and to improve the 
effectiveness of the patent examination process, the Office is revising 
the rules of practice to require that an applicant make an affirmative 
justification for a third or subsequent continuing application or 
second or subsequent request for continued examination.
    Comment 263: Two comments argued that the proposed rules prevent an 
applicant from filing even a single continuation application of an 
application in which a request for continued examination was previously 
filed, thereby eliminating access to the benefits conferred by 35 
U.S.C. 120.
    Response: The Office has modified the proposed changes such that an 
applicant is permitted under this final rule to file a first and second 
continuation application or continuation-in-part application without 
any justification, and is also permitted to file a request for 
continued examination in any one of the initial application, the first 
continuing application, or the second continuing application without 
any justification. Thus, under Sec.  1.78 as adopted in this final 
rule, an applicant may file two continuation applications without any 
justification, even if a request for continued examination was 
previously filed in the initial application.
    Comment 264: Several comments suggested that the definition of a 
``divisional application,'' as specified in proposed Sec.  1.78, is 
inconsistent with 35 U.S.C. 121 because, under proposed Sec.  1.78, a 
divisional application is limited to only one application, whereas 35 
U.S.C. 121 permits applicants to file a divisional application for each 
invention restricted out. Another comment suggested that 35 U.S.C. 121 
permits applications that are both a divisional application and a 
continuation-in-part application and any rule to the contrary is void.
    Response: This final rule defines a ``divisional application'' as 
an application ``that discloses and claims only an invention or 
inventions that were disclosed and claimed in a prior-filed 
application, but were subject to a requirement to comply with the 
requirement of unity of invention under PCT Rule 13 or a requirement 
for restriction under 35 U.S.C. 121 in the prior-filed application and 
not elected for examination and not examined in any prior-filed 
application.'' See Sec.  1.78(a)(2). This definition is consistent with 
35 U.S.C. 121, which states that the divisional application resulting 
from a restriction requirement is ``entitled to the benefit of the 
filing date of the original application,'' where the ``original 
application'' within the context of 35 U.S.C. 121 is the application 
from which the divisional application has been restricted. 
Additionally, Sec. Sec.  1.78(a)(2) and (d)(1)(ii) permit there to be 
as many divisional applications as there are inventions restricted out 
of the prior-filed application. Therefore, the changes adopted in this 
final rule allow an applicant to file a plurality of divisional 
applications resulting from a restriction requirement in the prior-
filed application so that the applicant may obtain examination of the 
claims that were withdrawn from consideration in the prior-filed 
application due to the requirement for restriction. Section 
1.78(d)(1)(ii) as adopted in this final rule also does not require that 
any divisional application be filed during the pendency of a single 
prior-filed application, but permits a divisional application to be 
filed as long as it meets the copendency requirement of 35 U.S.C. 120. 
Therefore, the definition of divisional application set forth in

[[Page 46814]]

Sec.  1.78(a)(2) is consistent with 35 U.S.C. 121.
    This final rule also permits an applicant to file an application 
that is in substance both a divisional application and a continuation-
in-part application. Specifically, Sec.  1.78(d)(1)(i) as adopted in 
this final rule permits an applicant to file an application directed 
both to an invention that was disclosed and claimed, but not elected 
for examination, in a prior-filed application, and an invention or 
subject matter that was not described or claimed in the prior-filed 
application. Such an application would be subject to the conditions 
applicable to other applications that disclose subject matter that was 
not disclosed in the prior-filed application (i.e., the conditions 
applicable to continuation-in-part applications). This is, because such 
application is not limited to inventions that were subject to a 
requirement for restriction by the Office in the prior-filed 
application, but instead includes subject matter not disclosed in the 
prior-filed application and thus was not subject to any requirement for 
restriction by the Office in any prior-filed application, it is a 
continuation-in-part application rather than a divisional application. 
The provisions of Sec.  1.78(d)(1)(ii) apply to divisional applications 
that disclose and claim only an invention or inventions that were 
disclosed and claimed in a prior-filed application, but were subject to 
a requirement to comply with the requirement of unity of invention 
under PCT Rule 13 or a requirement for restriction under 35 U.S.C. 121 
in the prior-filed application and not elected for examination and not 
examined in any prior-filed application.
    Comment 265: A number of comments argued that requiring an 
applicant to designate a limited number of (ten) representative claims 
for examination is contrary to statute, specifically, 35 U.S.C. 131 and 
112, as well as contrary to In re Wakefield, 422 F.2d 897, 164 U.S.P.Q. 
636 (C.C.P.A. 1970), because the rules limit an applicant's ability to 
claim the full scope of his or her invention and that it is the 
applicant, not the Office, who should determine the proper number of 
claims that particularly point out and distinctly claim the subject 
matter that applicants regard as their invention. Two comments argued 
that the courts have not recognized any statutory authority for 
rejecting claims as being ``unnecessary,'' citing Wakefield where the 
court held that the forty claims presented in the application at issue 
were not unduly multiplied. One comment also argued that Congress 
intended for each claim to be examined on the merits when it enacted 35 
U.S.C. 112, ] 2, citing In re Weber, 580 F.2d 455, 198 U.S.P.Q. 328 
(C.C.P.A. 1978), and one comment suggested that limiting the number of 
claims to be examined is contrary to 35 U.S.C. 131 because the 
invention is defined by all of the claims. A few comments suggested 
that the Office has a duty to examine all of the claims in a patent 
application when the applicant has paid the search, examination, and 
claim fees because Congress has authorized dependent claims and 
specified charges for those claims, and the Office is required to 
examine all claims, not just the designated ones. A number of comments 
argued that the Office lacks the statutory authority under 35 U.S.C. 
102, 103, 131, and 132 to presume that claims are patentably indistinct 
by requiring the applicant to designate representative claims from 
among copending, related applications. Finally, one comment argued that 
the patent statutes do not permit the Director to examine part of an 
application or less than the whole invention, and that the Director 
does not have statutory authority under 35 U.S.C. 2(b)(2) or 112, ] 2, 
to cause an application to be examined only if it does not result in 
too much work for the examiner, and then if it does, to shift the 
burden to the applicant to do the search and the examination.
    Response: The Office notes the concerns expressed by the public 
comment concerning the proposed ``representative claims'' examination 
approach. The Office also recognizes numerous comments suggested a 
claim threshold in place of representative claims. The Office took 
these comments into consideration and is not implementing a 
``representative claims'' examination approach. Instead, this final 
rule provides that if the number of independent claims is greater than 
five or the number of total claims is greater than twenty-five (a 
strategy based upon whether an application contains more than a given 
number of independent and total claims), the applicant must provide 
additional information about the claims to the Office in an examination 
support document to enable the Office to efficiently and effectively 
examine the application.
    Thus, the changes adopted in this final rule do not limit the 
number of claims that will be examined in an application because an 
applicant is always free to file as many claims as necessary to 
adequately protect the invention provided that applicant files an 
examination support document before the first Office action on the 
merits of the application. This final rule simply provides that an 
applicant who puts a disproportionate burden on examination by 
presenting more than five independent claims or twenty-five total 
claims must provide additional information to the Office to facilitate 
effective examination of the application. The Office, in turn, will 
ensure that every claim submitted in an application is examined prior 
to the issuance of a patent. Neither 35 U.S.C. 112 nor 131 provides 
that an applicant has an unfettered right to submit an unlimited number 
of claims. In contrast to Wakefield, where the Office declined to 
examine certain claims due to undue multiplicity, the changes adopted 
in this final rule do not limit the number of claims that will be 
examined in an application because an applicant is always free to file 
as many claims as necessary to adequately protect the invention.
    While this final rule does not implement a ``representative 
claims'' examination approach, that proposal approach was simply a 
mechanism to focus the examination process and in no way impacted the 
merits of the examination. Even under a ``representative claims'' 
approach, the Office would examine and determine the patentability for 
every claim in an application before issuing a patent on the 
application. Thus, a ``representative claims'' approach would have 
altered the examination process (i.e., determining when examination of 
certain claims takes place), but would not have changed the merits 
requirements of examination (i.e., the statutory standards of 
patentability).
    Comment 266: A number of comments suggested that the rationale 
presented in the Claims Proposed Rule is contrary to 35 U.S.C. 2(b), 
102, 131 and 132, in that the Office is responsible for granting and 
issuing patents. These comments stated that the examiner bears the 
initial burden of presenting a prima facie case of unpatentability, 
that the search is not the duty of the applicant but rather is the 
Office's responsibility under 35 U.S.C. 131, and the rules are 
inconsistent with the new fee structure which contemplates filing of 
additional claims with higher fees. A few comments suggested that the 
examination support document requirement improperly shifts the burden 
of assessing patentability to an applicant when that burden resides 
with the Office in the first instance under 35 U.S.C. 102. A few 
comments asserted that requiring an applicant to submit an examination 
support document constitutes an abdication of an inherently 
governmental function,

[[Page 46815]]

moves the United States one step closer to a registration system, and 
places an affirmative duty on an applicant to perform searches, 
ultimately exposing the applicant to a greater risk of an inequitable 
conduct challenge.
    Response: The changes adopted in this final rule do not mandate the 
submission of an examination support document. That is, an examination 
support document is only required if an applicant chooses to present 
more than five independent claims or more than twenty-five total claims 
for examination in an application. If an applicant will not present 
more than five independent claims and no more than twenty-five total 
claims for examination in any particular application, an examination 
support document is not required.
    The requirement for submission of an examination support document 
is not an abdication of the examination function, or a shifting of the 
burden to applicant to make a prima facie case of entitlement to a 
patent. The examination support document simply requires the applicant 
to provide additional information to the Office so that the Office may 
more effectively conduct a substantive examination of the application. 
The Office will examine and determine patentability for every claim in 
an application before issuing a patent.
    Comment 267: A few comments stated that the examination support 
document requirement transfers the costs of examination to applicants 
when applicants already pay filing fees.
    Response: The changes to Sec.  1.75(b) do not impose any additional 
Office fees on the applicant. The changes to Sec.  1.75(b) may increase 
costs for an applicant who presents more than five independent claims 
or twenty-five total claims in an application. The Office, however, 
considers it appropriate for applicants who place a disproportionate 
burden on examination by presenting more than five independent claims 
or twenty-five total claims to bear these additional costs to 
facilitate effective examination of the application. In any event, the 
Office's actual cost of examining an application for patent far exceeds 
the ``filing fees'' (i.e., the filing, search, examination, excess 
claims, and application size fees) charged to applicant. See United 
States Patent and Trademark Office Performance and Accountability 
Report Fiscal Year 2005 at 23 (2005) (Patent Efficiency Table).
    Comment 268: Several comments objected to the rebuttable 
presumption in Sec.  1.78(f)(2) as being contrary to the judicial 
precedent in other areas of patent law such as obviousness and 
enablement. One comment suggested that the patentably indistinct 
presumption is contrary to 35 U.S.C. 101, which allows a ``patent on an 
invention.'' One comment objected to the rebuttable presumption as 
being contrary to the patent statute that states in part that ``a 
person is entitled to a patent unless * * *. '' The comment suggests 
that these words in the patent statute evidence that the burden is on 
the Office to establish a prima facie case of unpatentability. A number 
of comments stated that as part of its statutory duty to determine 
patentability, the Office has the burden to determine patentable 
distinctness, and even under the conditions of Sec.  1.78(f)(2), it is 
improper to shift that burden to applicants. Further, some of the 
comments argued that the patentably indistinct presumption is contrary 
to case law because the Federal Circuit has repeatedly held that the 
burden of showing that the claims recited in copending, related 
applications are patentably indistinct rests with the Office, citing In 
re Kaplan, 789 F.2d 1574, 229 U.S.P.Q. 678 (Fed. Cir. 1986); In re 
Longi, 759 F.2d 887, 225 U.S.P.Q. 645 (Fed. Cir. 1985); In re Epstein, 
32 F.3d 1559, 31 U.S.P.Q.2d 1817 (Fed. Cir. 1994); In re Oetiker, 977 
F.2d 1443, 24 U.S.P.Q.2d 1443 (Fed. Cir. 1992); and In re Piasecki, 745 
F.2d 1468, 223 U.S.P.Q. 785 (Fed. Cir. 1984).
    Response: The presumption of patentably indistinct claims appearing 
in multiple applications as set forth in Sec.  1.78(f)(2) of this final 
rule is not contrary to the cited statutes or case law. Even if the 
applicant shows that the claims in question are patentably distinct 
from each other, it does not mean that the claims are also patentable 
over the prior art. That is, the rebuttable presumption is not a merits 
determination of patentability. It is simply a procedural tool 
requiring the applicant to help focus and consolidate the examination 
process.
    When the Office is faced with multiple applications containing 
overlapping subject matter, it is in the best interest of the 
applicant, the Office, and the public to ensure that patentably 
indistinct claims are identified early in the examination process. The 
applicant is responsible for drafting the application, including the 
claims, and is in the best position to identify indistinct claims 
spanning across multiple applications so that they can be consolidated 
in a single application, or so that the Office will at least be alerted 
to evaluate them for double patenting. Further, requiring the applicant 
to ferret out which claims are indistinct from each other is procedural 
in nature and assists the Office with processing multiple related 
applications, but should not be confused with a patentability 
determination on the merits. Such a procedural requirement is not 
contrary to statute or case law, but is fully within the Office's 
authority to regulate the procedure of examination.
    Comment 269: One comment suggested that 35 U.S.C. 116 provides for 
the filing of continuation applications and the Office does not have 
the authority to make changes.
    Response: 35 U.S.C. 116 provides for joint inventorship (35 U.S.C. 
116, ] 1), application for patent by the remaining inventors in the 
absence of a joint inventor (35 U.S.C. 116, ] 2), and correction of 
inventorship in an application for patent (35 U.S.C. 116, ] 3). 35 
U.S.C. 116 does not pertain to continuing applications.
    Comment 270: One comment suggested that the changes to Sec.  1.114 
violate 35 U.S.C. 133 because the Office would be assuming authority to 
hold an application ``abandoned'' even when a bona fide reply was 
timely filed.
    Response: 35 U.S.C. 133 provides that: ``[u]pon failure of the 
applicant to prosecute the application within six months after any 
action therein, of which notice has been given or mailed to the 
applicant, or within such shorter time, not less than thirty days, as 
fixed by the Director in such action, the application shall be regarded 
as abandoned by the parties thereto, unless it be shown to the 
satisfaction of the Director that such delay was unavoidable.'' An 
applicant's reply in prosecuting an application under a final Office 
action is limited to either appealing in the case of rejection of any 
claim (Sec.  41.31 of this title), or amending the claims as specified 
in Sec.  1.114 or 1.116. See Sec.  1.113(a). The admission of, or 
refusal to admit, any amendment after final rejection (Sec.  1.116) 
will not operate to save the application from abandonment. See Sec.  
1.135(b). Therefore, a reply to a final Office action other than an 
appeal, an amendment after final (Sec.  1.116) that places the 
application in condition for allowance, or a request for continued 
examination in compliance with Sec.  1.114 (including the requirement 
that any second or subsequent request for continued examination be 
accompanied by a grantable petition under Sec.  1.114(g)) is not a bona 
fide reply to the final Office action.
    Comment 271: A few comments suggested that the Office has a duty to 
examine all of the claims in a patent application when the applicant 
has paid the search, examination, and claim fees. The comments also 
argued that because Congress has authorized dependent claims and 
specified charges for those

[[Page 46816]]

claims, the Office is required to examine all claims, not just the 
designated ones. One comment also argued that the recently revised fee 
structure was put in place based on an allocation of resources for 
search workload on the examiner and therefore the Office is obligated 
to perform the search and cannot shift the burden to the applicant.
    Response: The Office recognizes the concern expressed in the public 
comments that the ``representative claims'' examination approach could 
be perceived as allowing claims to be issued that had not been fully 
examined. The Office is not adopting the ``representative claims'' 
examination approach in this final rule. This final rule instead 
provides that an applicant who puts a disproportionate burden on 
examination by presenting more than five independent claims or twenty-
five total claims must provide an examination support document to the 
Office before the first Office action on the merits to facilitate 
effective examination of the application. An applicant who presents 
five or fewer independent claims and twenty-five or fewer total claims 
need not provide an examination support document or other additional 
information to the Office. In either situation, the Office will ensure 
that every claim submitted in an application is examined prior to the 
issuance of a patent.
    Further, neither the excess claim fees nor the search fee is 
directly proportional to actual agency costs. The fee provisions are 
not a restriction on the agency's ability to promulgate reasonable 
regulations governing the application process.
    Comment 272: A few comments stated that the rules are arbitrary, 
capricious, and represent an overly aggressive interpretation of 
statutes, are beyond the power of the Office permitted under 35 U.S.C. 
2(b)(2), expose the Office to legal action under 5 U.S.C. 706(2)(c), 
and may require the Office to reimburse attorney fees under the Equal 
Access to Justice Act.
    Response: The changes adopted in this final rule are not arbitrary, 
capricious, an overly aggressive interpretation of the patent statute, 
or beyond the power of the Office rule making authority under 35 U.S.C. 
2(b)(2) for the reasons previously discussed in detail. Concisely put, 
the Office considers the changes being adopted in this final rule to be 
an appropriate exercise of its rulemaking authority under 35 U.S.C. 
2(b)(2). See, e.g., Lacavera v. Dudas, 441 F.3d 1380, 77 U.S.P.Q.2d 
1955 (Fed. Cir. 2006), Star Fruits S.N.C. v. United States, 393 F.3d 
1277, 73 U.S.P.Q.2d 1409 (Fed. Cir. 2005), and Arnold P'ship v. Dudas, 
362 F.3d 1338, 70 U.S.P.Q.2d 1311 (Fed. Cir. 2004).

J. Changes to Internal Practice

    Comment 273: A number of comments expressed support for the 
elimination of the first Office action final practice, and one comment 
encouraged the Office to adopt a practice of no first action final 
rejection in any continuing application where the factual record has 
changed. A number of comments, however, stated that a first action 
final may be appropriate where no effort has been made to advance 
prosecution, e.g., by adding to the factual record with additional 
evidence or amendments to the claims. One comment supported developing 
rules whereby an applicant's failure to prosecute could result in the 
close of prosecution unless adequate and sustained progress is being 
made in the application.
    Response: This proposed change has not been adopted. As discussed 
previously, this final rule, however, provides that an applicant may 
file two continuing applications plus a request for continued 
examination in any one of the initial application or two continuing 
applications (rather than only one continuing application or request 
for continued examination as proposed) without any showing. Therefore, 
the Office is retaining its first action final rejection practice.
    Comment 274: Several comments recommended that the Office develop 
procedures whereby an Office action could not be made final until the 
examiner was applying the exact same rejection as in the previous 
Office action, and/or to encourage the Office to issue non-final second 
Office actions. Several comments suggested reforming examination 
procedures so that the examiner does not issue a final rejection as 
long as prosecution is advancing.
    Response: The practice suggested by the comments would unduly 
prolong prosecution, which is counter to the Office's goal for reducing 
pendency. Thus, the Office and the applicants need to be efficient to 
reduce the backlog of applications and most importantly, to meet the 
public notice function of patent claims as quickly as possible. 
Further, as one comment recognized, a practice under which an Office 
action could not be made final until the examiner was applying the 
exact same rejection would result in an applicant being able to avoid a 
final Office action by continually amending the claims.
    Comment 275: A number of comments proposed that the Office permit 
amendments after final as matter of right, and assess a modest fee for 
the added examination burden. Most of these comments are in the context 
of a graduated credit system for continuation filings, with more credit 
being given during the first application and fewer ``counts'' or less 
time given in subsequent continuations. Several comments proposed that 
applicants should be permitted to respond to any new ground of 
rejection made in the final Office action without having to file a 
continuation application. Several comments suggested that the examiner 
should not make an Office action final whenever new art is applied, and 
one comment suggested an examiner must explain why the new art could 
not have been located during the first search.
    Response: To permit entry of amendments after final as a matter of 
right would unduly delay prosecution. An applicant may file an 
amendment to place the application in condition for allowance or in 
better form for consideration on appeal under Sec.  1.116. Furthermore, 
a new ground of rejection is only permitted in a final Office action 
under the limited circumstances. As discussed previously, in this final 
rule, the Office is revising second action final practice to provide 
that a second or any subsequent Office action on the merits may be made 
final, except when the Office action contains a new ground of rejection 
that is not: (1) Necessitated by applicant's amendment of the claims, 
including amendment of a claim to eliminate unpatentable alternatives; 
(2) necessitated by applicant's providing a showing that a claim 
element that does not use the phrase ``means for'' or ``step for'' is 
written as a function to be performed and does not otherwise preclude 
application of 35 U.S.C. 112, ] 6; (3) based on information submitted 
in an information disclosure statement filed during the period set 
forth in Sec.  1.97(c) with the fee set forth in Sec.  1.17(p); (4) 
based upon double patenting (statutory or obviousness-type double 
patenting); or (5) necessitated by applicant's identification of the 
claim or claims in a continuation-in-part application for which the 
subject matter is disclosed in the manner provided by 35 U.S.C. 112, ] 
1, in the prior-filed application. Since the applicant is often adding 
limitations that raise new issues that would require further 
consideration and/or search, it has long been the Office practice to 
make the action final at this point. Allowing an expanded practice in 
this area would undermine the goal of reducing patent pendency.
    Comment 276: A number of comments suggested providing examiners 
with additional time to consider replies after final rejection and

[[Page 46817]]

to provide a new full evaluation of the content of those replies.
    Response: No changes in after final practice are planned at this 
time. Under current practice, examiners consider any requests for 
reconsideration submitted after final rejection in accordance with 
Sec.  1.116.
    Comment 277: A number of comments suggested that the Office require 
a patentability review conference with others, similar to the pre-
appeal conference proceeding, prior to an Office action being made 
final, in order to address the problem of improper final Office actions 
and to expedite indication of allowable subject matter. One comment 
noted that the statistics show that less than half of applications that 
had a pre-appeal conference are going forward to appeal and indicate 
that many improper finals are being made. One comment stated that a 
supervisor should review all first Office actions in a second request 
for continued examination to determine if prosecution is proper.
    Response: The Office recognizes that it is important to make sure 
the final Office action is proper. The pre-appeal brief conference 
program is still an ongoing pilot program. The results of that program 
will help to determine whether the Office replaces it with, or adds, a 
``pre-final conference'' as suggested. Further, the pre-appeal brief 
conference program is designed for situations in which the applicant 
believes that the rejections of record are clearly not proper (and is 
not designed for ``close cases''). See New Pre-Appeal Brief Conference 
Program, 1296 Off. Gaz. Pat. Office at 67. Thus, data collected during 
pre-appeal brief conferences (e.g., with respect to re-opening rates) 
cannot validly be extended to all applications.
    In addition, the Office has an ongoing ``in process review'' of 
applications to identify problems and trends. Each Technology Center 
develops ongoing action plans and training each year to address the 
problems/trends found via the ``in process reviews'' and the pre-appeal 
brief conferences. Additionally, the Office will reinforce, during the 
training on this final rule, issues such as proper final rejection 
practice, the importance of making proper final rejections, and the 
importance of indicating allowable subject matter at the earliest 
possible time. Furthermore, if an applicant believes a rejection was 
improperly made final, applicant may seek review by filing a petition 
under Sec.  1.181.
    Comment 278: A number of comments stated that the Office should 
continue and expand ongoing efforts to hire and retain patent 
examiners. One comment suggested that ``[h]iring should be the 
centerpiece of the Office's strategy.'' A number of comments stated 
that the Office has not provided sufficient evidence to show why the 
Office could not solve the backlog problem by hiring more examiners. 
One comment argued that the Office should have sufficient funding to 
pay for additional resources (e.g., more examiners) needed to examine 
the backlog of applications in view of the recent increase in patent 
fees. One comment stated that the Office has not supported its 
assertion that it cannot hire enough examiners to reduce pendency. 
Another comment stated that the Office should seriously consider hiring 
retired or former examiners or patent practitioners to be trainers or 
to assist examiners. In particular, one comment stated retired 
examiners should be hired to work on specific big applications to 
reduce the burden on examiners. Another comment stated the Office 
should hire ``generalists'' instead of ``ultra specialized advanced 
degree scientists and engineers'' to obtain more flexibility in the 
workforce.
    Response: Hiring additional examiners remains an important 
component of the Office's overall plan to reduce pendency of patent 
applications. The Office is committed to the hiring of as many 
examiners as resources permit. The ability to hire qualified new 
examiners is affected by many components, such as budget, the economy, 
the availability of scientists and engineers, and the ability to absorb 
and train new employees. Furthermore, it will take many years to 
develop an experienced patent examining corps of sufficient size to 
address the growing backlog of unexamined patent applications. The 
Office recognizes that hiring alone will not reduce the backlog of 
pending applications in the near future. As a result, the Office is 
actively seeking ways for retaining more employees, such as retention 
bonuses. The Office continues to become more efficient by implementing 
many initiatives, such as the current regulatory changes, to reduce 
pendency.
    The Office plans to hire 1,200 examiners each year for the next 
five fiscal years. See United States Patent and Trademark Office Fiscal 
Year 2008 President's Budget at 20-21 (2007). This will result in the 
number of patent examiners increasing from 4,779 at the end of fiscal 
year 2006 to 7,118 at the end of fiscal year 2012 (accounting for 
attrition). See id. Even with this increase in the size of the Patent 
Examining Corps, the Office anticipates that average pendency to first 
Office action will increase from 22.6 months in fiscal year 2006 to 
28.9 months in fiscal year 2012, and that average total pendency will 
increase from 31.1 months in fiscal year 2006 to 38.6 months in fiscal 
year 2012. See id.
    Comment 279: A number of comments stated that the current 
examiners' production system in the Office encourages the filing of 
continuing applications and requests for continued examination. In 
addition, several comments stated that the production system also 
encourages more restrictions and unwillingness to consider any after-
final amendment. The comments suggested several alternative accounting 
schemes to encourage examiners to examine more non-continuing 
applications and provide more thorough first Office actions, including 
giving less credit for work done in continuation applications, 
divisional applications and requests for continued examination, giving 
examiners more credit for first Office actions as opposed to disposals, 
giving examiners credit for claims disposed as opposed to applications 
disposed, or giving examiners credit based on numerous application 
factors such as specification length, technology complexity, number and 
complexity of the claims, and pertinence of prior art submitted. One 
comment suggested only having team examination and production goals. 
One comment suggested the Office should use a performance system, such 
as the system recently established by the Department of Defense. One 
comment suggested that examiners should not have any time constraints. 
Another comment stated the hours per disposal should be decreased to 
improve production. Several comments argued that timesaving for 
examiners needs to be tied with an agreement with the Patent Examining 
Corps to increase productivity and decrease pendency due to the amount 
of time saved in light of the proposed changes to the examination of 
claims. One comment argued the rule changes will likely result in less 
time for the examiners and it is unclear how this will result in more 
thorough and reliable examination. The comments strongly suggested that 
any changes to the examiners' production system should be transparent 
to the public to install public confidence in such changes.
    Response: The Office expects to gain a more focused quality 
examination as a result of these rule changes. It is expected that 
these rules will make the exchange between the examiner and applicants 
more efficient and effective. Issued patents will be examined more

[[Page 46818]]

thoroughly, making them easier to evaluate, enforce and litigate. 
Furthermore, the patents will issue sooner, giving the public a clearer 
understanding of what is patented. In any event, the Office is in the 
process of reassessing patent examiner production goals, appraisal 
plans, and award systems. Absent significant changes to the patent 
examination process, the Office does not consider it reasonable to 
expect that changes to patent examiner production goals, appraisal 
plans, and award systems alone will be sufficient to address the 
growing backlog of unexamined patent applications while maintaining a 
sufficient level of quality.
    Comment 280: Several comments stated that examiners should be given 
more production time for certain situations, such as for applications 
with more than twenty claims, for consideration of over fifteen to 
twenty cited references and for responding to after-final amendments. 
One comment stated that primary examiners should be given more time to 
review a junior examiner's work.
    Response: Changes to patent examiner production goals are beyond 
the scope of the proposed changes to the rules of practice. Therefore, 
whether examiners should be given more production time for certain 
situations is not discussed in this final rule. An examination support 
document in compliance with Sec.  1.265 will assist the examiner in the 
examination of an application that contains more than five independent 
claims or more than twenty-five total claims, resulting in a more 
effective and focused examination. For example, citing the most 
relevant references and identifying all of the limitations of each of 
the claims that are disclosed by the references will help the examiner 
to consider the most relevant prior art more thoroughly. The Office 
already provides time for training junior examiners and reviewing their 
work. Furthermore, a sampling of ``in process reviews'' for each 
Technology Center helps identify training needs in a focused manner. 
The Office of Patent Training is thoroughly preparing each new examiner 
in proper practice and procedure with access to a dedicated trainer for 
the first eight months; after that, the examiner is placed in a 
traditional setting with proper supervision and review of his or her 
work.
    Comment 281: A number of comments suggested that the Office could 
retain more examiners by increasing compensation and offering better 
working conditions. A number of comments also suggested that if it is 
necessary to increase examiner salaries, changes to Title 5 of the 
United States Code should be requested by the Office. One comment 
stated that the salary for starting examiners should also be doubled. 
One comment stated that the Office should seek authority to increase 
salaries through either existing OPM processes or through restructuring 
to a quasi-government corporation. One comment suggested charging fees 
for responding to an Office action and for interviews, and using this 
money to hire more examiners and pay for retention initiatives. Another 
comment suggested establishing a salary increase when an examiner 
passes a test at a number of pay grades. One comment stated that a 
bonus system should be established. Another comment has suggested 
increased salary levels for art units with high backlogs. Several 
comments stated that increased filing fees should go towards increased 
salary for examiners. One comment explained that the Office could give 
examiners better working conditions by placing less stress on the more 
experienced examiners. Another comment suggested the Office should 
explore more flexible work schedules, including part-time arrangements.
    Response: The Office already provides many first rate benefits to 
its employees. The Office is at the forefront in government for 
teleworking opportunities for the staff. The Office has also adopted a 
variety of creative work schedules such as: Maxi-flex, compressed and 
alternate work schedules, part-time and flex-time for all employees. 
Additionally, the Office offers paid overtime, compensatory time and 
credit hours programs. The Office has transitioned into a paperless 
environment and deployed state-of-the art technology to its employees. 
The Office has relocated to a new campus, and provides amenities such 
as a first class child-care facility, a state-of-the-art fitness center 
and a cafeteria.
    The Office already provides a robust bonus system for examiners 
that enables one to earn up to ten percent of one's salary per year in 
bonus compensation. Examiners are already on a special pay scale, with 
the most recent increase of seven percent for all patent professionals, 
granted in December 2006. In addition, an examiner receives regular 
salary increases upon promotions to increasing levels of 
responsibilities.
    Comment 282: Several comments stated the Office should authorize 
overtime to work on the backlogs. One comment specifically suggested 
that overtime pay should be 125 percent of the current pay rate, and 
should only be available to work on first Office actions on the merits.
    Response: Examiners who have been certified as capable of working 
independently by their supervisors are currently authorized to work 
overtime. The overtime pay rate is set by statute. See 5 U.S.C. 5542. 
The Office has recently begun distributing laptop computers to 
examiners to further encourage overtime.
    Comment 283: A number of comments encouraged the Office to consider 
establishing satellite offices in different areas in the United States 
to assist in recruiting and retaining of examiners. The comments 
further explained that satellite offices could tap into a greater pool 
of potential new examiners, as there would be multiple working 
locations. In addition, the comments stated that satellite offices 
could specialize in certain technologies that are prevalent in the area 
of the satellite office. Another comment pointed out that a satellite 
office would facilitate more personal interviews, which would expedite 
prosecution. The comments also stated that salary structures could be 
adjusted depending on the cost of living within the area surrounding 
the satellite office.
    Response: The Office is considering establishing satellite offices 
as reflected in the Office's 2007-2012 Strategic Plan.
    Comment 284: A number of comments stated that the Office should 
increase training requirements for examiners in order to improve patent 
quality and retain more examiners. One comment suggested using any 
increase in patent fees to provide training. Several comments offered 
assistance in providing technical and legal training to the examiners. 
One comment suggested that examiners should receive more training on 
making proper rejections under 35 U.S.C. 103, and also suggested 
testing examiners periodically. Another comment stated that examiners' 
prior art searching is poor, and that the Office is not making efforts 
to stem poor rejections, which lead to rework. One comment suggested 
that the Office should train examiners using self-training programs 
utilizing videos. Another comment stated that training should be 
outsourced. Several other comments suggested training potential new 
examiners by creating a patent examination curriculum for universities.
    Response: The Office has redesigned the training program of new 
examiners and increased technical and legal training for other 
examiners and patent professionals. Currently, the first classes of new 
hires have completed their training in the new Patent Training Academy 
program, wherein examiners

[[Page 46819]]

go through eight months of intensive training prior to being assigned 
to an art unit. Mirroring a collegiate environment, examiners are 
trained in a variety of disciplines, including technology skills, legal 
skills, and procedural requirements.
    For non-first year examiners, the Office has expanded training to 
include patent law and evidence. Each employee must attend a specified 
number of training hours in a variety of pertinent legal and technical 
subjects. Additionally, the Office also offers a Law School Tuition 
Assistance Program (LSTAP) to qualified employees as an extension of 
the Office's internal training program. Reimbursements for university 
technical training courses related to the technology being examined are 
also available for employees. Creating a partnership between the Office 
and interested universities to offer an undergraduate course in patent 
law and examination practice to highlight career opportunities in the 
intellectual property field is also being investigated.
    Comment 285: A number of comments stated that the Office did not 
address improvements in the internal examination process. One comment 
alleged that the Office did not consider any changes to address 
examiners' errors that extend the prosecution. Several comments 
suggested that the Office should improve the examination process before 
implementing the rule changes.
    Response: The Office is implementing many initiatives including 
improvements in the internal examination process as well as the rule 
changes in this final rule. To realize the effectiveness of these 
initiatives in the near term, the Office is implementing many of them 
simultaneously. The Office seeks ways to improve internal examination 
processes by providing training created as a result of internal reviews 
that identify areas where challenges exist.
    Comment 286: Several comments encouraged the Office to take 
additional measures to improve the quality and clarity of Office 
actions, in particular first Office actions. One comment stated that 
examiners should use ``plain English'' in explaining the rationale 
behind rejections.
    Response: The Office recognizes that the quality of Office actions 
is of great importance. There are several quality initiatives in place 
to insure that quality continues to improve. The new Patent Training 
Academy emphasizes the importance of high quality Office actions. 
Current interview practice encourages the use of interviews to clarify 
the examiner's position, as necessary. The Office also has writing 
classes available to employees.
    Comment 287: Several comments stated that examiners should be 
encouraged to allow an application, or to point out allowable subject 
matter, in the first Office action, if appropriate. Several comments 
also suggested requiring examiners to propose amendments when 
prosecution reaches a certain point, such as the filing of a second 
request for continued examination.
    Response: The Office has previously adopted, in part, these 
comments. It is current Office policy to encourage examiners to suggest 
allowable subject matter as early as possible in the prosecution in 
order to achieve the Office's goal of compact prosecution. It has long 
been a standard in the examiner's performance appraisal plan, and it is 
indeed an indicia of outstanding performance, to indicate allowable 
subject matter at the earliest time possible. (See also, e.g., MPEP 
Sec.  707.07(j)(III) EARLY ALLOWANCE OF CLAIMS, ``Where the examiner is 
satisfied that the prior art has been fully developed and some of the 
claims are clearly allowable, the allowance of such claims should not 
be delayed''; MPEP Sec.  2106 (II), ``Whenever practicable, Office 
personnel should indicate how rejections may be overcome and how 
problems may be resolved * * * .''; and MPEP Sec.  2164.04, ``In other 
words, the examiner should always look for enabled, allowable subject 
matter and communicate to applicant what that subject matter is at the 
earliest point possible in the prosecution of the application.'').
    Comment 288: There were a number of comments pertaining to the 
quality review of examiners' work product. A number of comments stated 
that the Office should limit its ``second-pair-of-eyes'' review to the 
work of examiners that have been identified as needing more review in 
their annual performance appraisal. The comment further explained that 
the Office should focus more intensive review on an examiner's work if 
it is the principal cause for the failure to close prosecution on an 
invention (e.g., by making poor rejections). Another comment suggested 
eliminating the review of allowed applications and having the 
``review'' examiners work on the backlog. One comment stated that 
supervisors should review all Office actions for examiners that have 
fewer than three years experience unless they have passed a proficiency 
examination. Another comment stated the review should spot factual 
issues instead of just legal issues to better improve Office action 
quality.
    Response: The Office already has focused ``second pair of eyes'' 
reviews only for those examiners and/or technology areas where it has 
been determined necessary. Additionally, the Office has an ongoing ``in 
process review'' of applications to identify problems and trends. Each 
Technology Center develops ongoing action plans and training each year 
to address the problems/trends found via the ``in process reviews'' and 
other sources, such as the pre-appeal brief conferences. Supervisors, 
or their designated primary examiners, currently review all the work of 
examiners who do not have signatory authority. All of these reviews do 
encompass both factual and legal issues.
    Comment 289: A number of comments stated that examiners should be 
encouraged or required to conduct more interviews throughout the 
prosecution, including preexamination interviews and after-final 
interviews. Several comments suggested that all interviews should 
include the supervisor of the examiner or a person with signatory 
authority. Several other comments suggested giving examiners a count, 
or credit, for an interview, and charging a fee for interviews. Another 
comment stated that examiners should be trained to give more productive 
interviews.
    Response: Interview practice is set forth in Sec.  1.133 and MPEP 
Sec. Sec.  713 through 713.10. Normally, one interview after final 
rejection is permitted. See MPEP Sec.  713.09. The Office also provides 
examiners extra time to conduct an interview. In June 2006, this 
practice was expanded to allow extra time for telephone interviews 
initiated by applicants or their representatives; it had previously 
only been available for personal (face-to-face) interviews. The Office 
conducted a pilot program permitting an interview before the first 
Office action in applications that were assigned to certain art units 
in Technology Center 3600. See Notice of Pilot Program to Permit Pre-
First Office Action Interview for Applications Assigned to Art Units 
3624 and 3628 and Request for Comments on Pilot Programs, 1281 Off. 
Gaz. Pat. Office 148 (Apr. 27, 2004). Section 1.133(a)(2) was amended 
in November of 2005 to permit an interview before the first Office 
action in any application if the examiner determines that such an 
interview would advance prosecution of the application. See Provisions 
for Claiming the Benefit of a Provisional Application With a Non-
English Specification and Other Miscellaneous Matters, 70 FR at

[[Page 46820]]

56121, 56128, 1299 Off. Gaz. Pat. Office at 144, 150. As discussed 
previously, if the examiner, after considering the application and any 
examination support document, still has questions concerning the 
invention or how the claims define over the prior art or are 
patentable, the examiner may request an interview before the first 
Office action.
    Comment 290: One comment stated that the Office should encourage 
the submission of more useful information disclosure statements, which 
contain statements of materiality and have provisions to discourage 
``dumping'' of references. Such an information disclosure statement may 
be filed at a reduced fee amount. Another comment questioned whether 
the Office has considered a rule that states that duty of disclosure 
terminates at the close of prosecution.
    Response: The Office recently published proposed changes to the 
information disclosure statement practice which will encourage the 
submission of more useful information. See Changes To Information 
Disclosure Statement Requirements and Other Related Matters, 71 FR at 
38812-16, 38820-22, 1309 Off. Gaz. Pat. Office at 27-31, 34-36.
    Comment 291: A number of comments suggested that the Office should 
make better use of search and examination reports from other 
intellectual property offices and PCT search and examination 
authorities. On the other hand, one comment stated that the Office 
should not rely on foreign office searches. Several comments further 
suggested separating the search and examination functions and 
outsourcing the search function. One comment stated that U.S. and PCT 
prosecution should be done at the same time.
    Response: The Office recognizes the importance of leveraging the 
search results from other intellectual property offices. One of the 
specific action plans of the United States Patent and Trademark Office 
21st Century Strategic Plan is to share search results with other 
intellectual property offices. Since the beginning of 2003, the Office, 
the European Patent Office and the Japan Patent Office (the Trilateral 
Offices) have participated in search exchange projects aimed at 
promoting the mutual exploitation of search results. The Office 
implemented the Patent Prosecution Highway pilot program in July 2006. 
See Patent Prosecution Highway Pilot Program between the United States 
Patent and Trademark Office and the Japan Patent Office, 1307 Off. Gaz. 
Pat. Office 61 (June 13, 2006). Under the Patent Prosecution Highway 
pilot program, an applicant whose claims are determined to be 
patentable by the Japan Patent Office may request that the 
corresponding application filed in the Office be advanced out of turn 
for examination provided certain conditions are met. The Patent 
Prosecution Highway pilot program allows the Office to exploit the 
search and examination results of the Japan Patent Office and 
applicants to obtain corresponding patents faster and more efficiently. 
Additionally, whenever the Office is designated as the International 
Searching Authority, both the international application and the 
application filed under 35 U.S.C. 111(a) are assigned to the same 
examiner, if possible.
    Comment 292: A number of comments stated that all related 
applications should be assigned to the same examiner, including 
applications with overlapping disclosures.
    Response: The Office will continue to make reasonable efforts to 
ensure that related applications are assigned to the same examiner, if 
possible. However, the Office normally assigns divisional applications 
to the technology area most appropriate for the claimed subject matter. 
In fact, this is in part why this final rule requires applicants to 
identify certain related applications. See Sec.  1.78(f).
    Comment 293: A number of comments suggested creating a new or 
modified accelerated examination procedure. One comment requested a 
procedure to permit accelerated examination for applications that enter 
the national stage under the Patent Cooperation Treaty. Another comment 
stated that accelerated examination could be available to applications 
containing ten or fewer representative claims. Another comment 
suggested allowing accelerated examination if the applicant permits an 
inter partes submission of a prior art statement and applicant provides 
either an examination report from either the European Patent Office or 
the Japan Patent Office, or pays a high fee for a special search. One 
comment stated high technology areas should be given examination 
priority. Another comment suggested requiring expedited replies in 
continued examination applications and not giving extensions of time 
under Sec.  1.136(a). Another comment requested accelerated examination 
for independent inventors.
    Response: The Office has long provided for advancement of 
examination upon granting a petition to make special. See Sec.  1.102 
and MPEP Sec.  708.02. The Office also announced a revised accelerated 
examination procedure, and the goal is to complete examination within 
twelve months of the filing date of the application under this program. 
See Changes to Practice for Petitions in Patent Applications To Make 
Special and for Accelerated Examination, 71 FR at 36323-27, 1308 Off. 
Gaz. Pat. Office 106-09. Any applicants, including independent 
inventors, may participate in the revised accelerated examination 
program which provides an expedited reply procedure. As discussed 
previously, under the Patent Prosecution Highway pilot program, an 
applicant whose claims are determined to be patentable by the Japan 
Patent Office may request that the corresponding application filed in 
the Office be advanced out of turn for examination provided certain 
conditions are met.
    Comment 294: Several comments suggested that examiners should 
strictly follow the guidance set forth in MPEP section 708 and examine 
applications with the oldest effective filing date first. On the other 
hand, several comments stated the Office should promote earlier 
examination of non-continuing applications by giving continuation 
applications a lower priority in the examination queue.
    Response: The Office will continue to follow the guidance set forth 
in MPEP section 708 pertaining to the order of examination of 
applications, including that ``[e]ach examiner will give priority to 
that application in his or her docket, whether amended or new, which 
has the oldest effective U.S. filing date.'' An exception to this 
guideline is an application in which examination has been advanced 
pursuant to Sec.  1.102.
    Comment 295: One comment suggested examiners should not just search 
the claimed invention, but also subject matter that might be reasonably 
claimed at a later time.
    Response: MPEP Sec.  904 sets forth that ``[t]he first search 
should cover the invention as described and claimed, including the 
inventive concepts toward which the claims appear to be directed.'' 
Additionally, MPEP Sec.  904.02(a) states that ``[t]he field of search 
extends to all probable areas relevant to the claimed subject matter 
and should cover the disclosed features which might reasonably be 
expected to be claimed.''
    Comment 296: Several comments encouraged the Office to hire 
efficiency experts, or a task force, to find the best ways to improve 
the quality and efficiency of examination.
    Response: The Office expects these rule changes to improve the 
quality and efficiency of examination. The Office will evaluate the 
effectiveness of the rule changes in partnership with the

[[Page 46821]]

Office's customers and employees as all gather experience in operating 
under these adjustments. The Office is currently studying all 
suggestions, including those in the various studies made of the Office.
    Comment 297: One comment requested that the panel involved in a 
pre-appeal brief conference be required to provide legal and factual 
reasoning for the decision to both the examiner and the practitioner so 
as to better make the decision a teaching tool.
    Response: The Pilot Pre-Appeal Brief Conference Program has been 
extended until further notice. See Extension of the Pilot Pre-Appeal 
Brief Conference Program, 1303 Off. Gaz. Pat. Office 21, (February 7, 
2006) (notice). Since this program is still in the pilot phase, it 
would be premature to make any changes until a full evaluation of the 
entire program is completed. Furthermore, the purpose of this program 
is to provide a quick relief for applications that are clearly not in 
condition for appeal, so that applicant does not have to go through the 
expense of preparing and filing an appeal brief. Preparing a written 
decision of the conference would unduly delay the process.
    Comment 298: Several comments stated that the Office should create 
an Ombudsman position to decide issues regarding examination errors by 
examiners.
    Response: The Office has many effective mechanisms to decide issues 
regarding alleged ``examination errors'' by examiners. Practitioners 
have several options, including but not limited to, responding on the 
record, calling a supervisor, requesting a pre-appeal brief conference, 
filing a petition, and filing an appeal.
    Comment 299: One comment requested a return to the appeal rules 
where the examiners are not able to make new grounds of rejection 
during appeal.
    Response: The rules of practice for the appeal process were changed 
in 2004 to permit a new ground of rejection in an examiner's answer. 
See Rules of Practice Before the Board of Patent Appeals and 
Interferences, 69 FR 49960, 1286 Off. Gaz. Pat. Office 21 (September 7, 
2004) (final rule). The approval of the appropriate Technology Center 
Director, or his or her designee, is needed for such a new ground of 
rejection, which should be rare. In response to any new ground of 
rejection made in an examiner's answer, appellant has the options to 
request that prosecution be reopened and to request that the appeal be 
maintained under Sec.  41.39(b). There have been no demonstrated 
problems to date, thus the Office does not plan to change this 
practice.
    Comment 300: One comment suggested accepting more ``variations'' in 
filings to reduce the number of non-compliant notices sent.
    Response: The Office waives certain requirements set forth in Sec.  
1.121(c) and may accept certain non-compliant amendments. See 
Acceptance of Certain Non-Compliant Amendments Under 37 CFR 1.121(c), 
1296 Off. Gaz. Pat. Office 27 (July 5, 2005). Practitioners and 
applicants, however, are responsible to know the laws and rules 
relating to prosecuting patent applications and to keep current with 
any changes. The Office will continue to review common problems that 
arise, and implement solutions as appropriate.
    Comment 301: One comment requested that the Office publish, once a 
month, a projection of when a new application will be taken up for 
examination so that applicants can better manage the filing of 
preliminary amendments.
    Response: The Office currently publishes in each issue of the 
Official Gazette the average filing date of the applications that 
received a first Office action during the preceding three months for 
each Technology Center Work Group.
    Comment 302: One comment suggested that the Office should allow 
more documents to be filed via the Office electronic filing system. 
Another comment stated the Office should require electronic filing and 
that all prosecution be performed electronically.
    Response: The Office permits applicants to file many applications, 
fees, and correspondence (e.g., amendments and replies) electronically 
via the Office electronic filing system (EFS-Web) with a few exceptions 
(e.g., Credit Card Authorization Form (PTO-2038), maintenance fees, new 
plant applications and color plant drawings). There are no plans to 
make electronic filing mandatory, although special programs (e.g., 
accelerated examination) do require electronic filing. See Changes to 
Practice for Petitions in Patent Applications To Make Special and for 
Accelerated Examination, 71 FR at 36323-27, 1308 Off. Gaz. Pat. Office 
106-09.
    Comment 303: One comment proposed requiring applicants to give an 
opinion of the usefulness or commercial potential of the invention.
    Response: The Office is not adopting the requirement that an 
examination support document contain a concise statement of the utility 
of the invention. An opinion from the applicant on the commercial 
potential of the invention is generally unnecessary in determining the 
patentability of the claimed invention. However, applicant may submit 
objective evidence of commercial success when applicant seeks to rebut 
an obviousness rejection under 35 U.S.C. 103. See Sec.  1.132 and MPEP 
Sec.  716.03.
    Comment 304: One comment requested prioritizing the order of 
examination based on such factors as the economic impact and value to 
society, the quality of the technical description of the invention and 
the quality of prior art cited. The comment also suggested requiring 
applicants to state in their application how the invention will be 
distributed to the public.
    Response: It would be very difficult to evaluate and assess these 
subjective factors for each application filed. In addition, most of 
this information would not be helpful in determining the patentability 
of the claimed invention.
    Comment 305: One comment suggested creating an electronic search 
tool that would automatically compare the claim language to prior art 
and provide complete searches in under ten minutes.
    Response: The Office has been evaluating tools to improve the 
examination practice. Although the Office is routinely seeking ways to 
improve automated tools, the resources needed for implementation and 
the applicability of the tools must be considered and weighed. Often, 
the application of search tools is limited to specific technologies. 
For example, in many biotechnology applications, the Office employs an 
Automated Biotechnology Sequence Search System (ABSS) to compare 
genetic sequences submitted with applications to a number of sequence 
databases. The Office's Scientific and Technical Information Center 
(STIC) conducts between 10,000 and 15,000 of these searches a year. Due 
to the number of requests and because the search runs against multiple 
databases, ABSS searches can be time-consuming. In other technologies, 
such as electrical and mechanical arts, STIC provides the option of 
conducting a Patent Linguistic Utility Service (PLUS) search, which 
runs significant words from sections of the specification against the 
full text of the United States Patent and United States Pre-Grant 
Publication databases. STIC is performing over 20,000 of these searches 
a year. While these searches are done quickly, limitations in key word 
searching are not always reliable in finding relevant prior art.
    Comment 306: One comment stated that the Office should create a 
better

[[Page 46822]]

search engine so inventors can more easily perform better searches.
    Response: The Office continues to explore various ways to 
disseminate information and improve the searching capabilities of the 
public. Currently, the Office allows applicants and inventors to search 
on-line using Patent Full-Text and Full-Page Image Databases (http://www.uspto.gov/patft/index.html) and works in concert with eighty-three 
Patent and Trademark Depository Libraries (http://www.uspto.gov/go/ptdl/ ptdl/) throughout the United States to offer the public extension 
research capabilities. The Office also has a library and tools at the 
Alexandria campus for the public to use.
    Comment 307: One comment suggested that procedures for appeals and 
petitions should be changed to be less costly and to result in more 
timely decisions. One comment suggested the Office waive the notice of 
appeal fee and the appeal brief fee while the applicant awaits a 
decision on petition to invoke supervisory authority relating to a 
premature final rejection in an Office action.
    Response: Most petition fees are set by regulation. The petition 
fee amounts that are set by regulation are set at an amount based upon 
the resources required to handle and decide the petition. See Changes 
to Support Implementation of the United States Patent and Trademark 
Office 21st Century Strategic Plan, 69 FR 56482, 56491-93 (Sept. 21, 
2004), 1287 Off. Gaz. Pat. Office 67, 75-76 (Oct. 12, 2004). The notice 
of appeal fee and the appeal brief fee are set by statute and cannot be 
waived. Additionally, the appeal fees recover only a fraction of the 
Office cost of handling and deciding the appeal.
    With respect to petitions, the Office is taking the necessary steps 
to minimize the backlog and to respond to petitions in a timely 
fashion. Within the Technology Centers, almost all petitions for relief 
from improper final rejections or restrictions are answered in a timely 
fashion. The Office is working to ensure that most of the petitions for 
relief from improper final rejections or restrictions are decided 
within four months from when they are filed, and continues to work on 
ways to make the process consistent across the different Technology 
Centers. The Office has also taken major steps to eliminate delays with 
the appeal process. The BPAI has radically reduced the inventory of 
pending appeals during the last five fiscal years.
    The Office also recognizes that it is important to make sure that 
the finality of any final Office actions is proper. It is the Office's 
experience that applicants who seek review of the finality of an Office 
action also request review of the merits of the rejections contained in 
the final Office action. The propriety of the finality of an Office 
action is purely a question of Office practice that is wholly distinct 
from the merits of the rejections contained in the final Office action 
rejection. See MPEP Sec.  706.07(c). The propriety of the finality of 
an Office action is properly raised in a petition under Sec.  1.181, 
and is not a proper basis for an appeal or complaint to the BPAI during 
an appeal. See id. Likewise, arguments relating to the merits of the 
rejections contained in the final Office action rejection are properly 
raised in an appeal to the BPAI, and are not a proper basis for a 
petition under Sec.  1.181 or for contesting the propriety of the 
finality of an Office action.
    The rules of practice provide that the mere filing of a petition 
under Sec.  1.181 will neither stay any period for reply that may be 
running against the application, nor act as a stay of other 
proceedings. See Sec.  1.181(f). While the Office has put in place 
procedures to decide the appeals and petitions in a timely manner, the 
applicant is responsible to continue to prosecute the application 
consistent with Sec.  1.181(f). Thus, there may be situations in which 
it is necessary for an applicant to file a notice of appeal to maintain 
the pendency of an application while a petition under Sec.  1.181 
requesting review of the finality of an Office action is being decided. 
The filing of a notice of appeal, however, does not moot such a 
petition under Sec.  1.181, so the Office will decide a petition under 
Sec.  1.181 requesting review of the finality of an Office action even 
if the applicant has filed a notice of appeal in the application. In 
such a situation, applicants should also request a pre-appeal brief 
conference with the filing of a notice of appeal. The pre-appeal brief 
conference will be conducted and the applicant will be notified of the 
result of the pre-appeal brief conference before the appeal brief and 
appeal brief fee must be filed. This should ensure that any petition 
under Sec.  1.181 requesting review of the finality of an Office action 
is decided before the applicant must file the appeal brief and appeal 
brief fee. If the Office determines that the finality of the rejection 
was premature, the finality of the Office action will be withdrawn and 
any fees paid for the notice of appeal and the appeal brief can be 
applied to a later appeal on the same application. See MPEP Sec.  
1207.04.
    Comment 308: Several comments stated that the Office should 
exercise better control over restriction practices. Several comments 
stated that the Office should encourage claims of different statutory 
classes to be filed in one application to improve examiner efficiency. 
One comment asserted that disposal pressures on examiners in the 
biotechnology area are totally unrealistic and have led to legally 
ridiculous restriction requirements. Several comments suggested that 
restriction reform is needed. Several comments suggested that the 
Office adopt the unity of invention standard. Several comments 
suggested an interim standard based on current PCT unity of invention 
practice should be available at the option of the applicant as an 
alternative to adopting unity of invention practice. Some comments 
expressed the opinion that current restriction practice in Technology 
Center 1600 (biotechnology and organic chemistry) requires applicants 
to file too many continuing and divisional applications. One comment 
expressed the opinion that current restriction practice is a result of 
the examiners' production system. Several comments stated that 
restriction is necessary to avoid abusive filing tactics by applicants 
seeking to circumvent the proposed regulation of continued examination 
filings. Several comments suggested that the Office eliminate 
restriction practice. Another comment stated that if proposed Sec.  
1.78(d)(1)(ii) is adopted, the Office should be bound by an initial 
restriction requirement and Sec.  1.146, authorizing species 
restrictions, should be repealed. One comment suggested that if 
restriction practice must be maintained, it should be limited to 
applications in which two claimed inventions are literally unrelated, 
and all divisional applications should be examined by the same 
examiner.
    Response: As part of the United States Patent and Trademark Office 
21st Century Strategic Plan, restriction reform was studied 
extensively. See Request for Comments on the Study of Changes Needed to 
Implement a Unity of Invention Standard in the United States, 68 FR 
27536 (May 20, 2003), 1271 Off. Gaz. Pat. Office 98 (June 17, 2003) 
(notice). A revision of the study was posted in November 2003, and the 
study was expanded to include four restriction reform options. See 
Notice of the Availability of and Request for Comments on Green Paper 
Concerning Restriction Practice, 70 FR 32761 (June 6, 2005), 1295 Off. 
Gaz. Pat. Office 146 (June 28, 2005) (notice) and the extension of the 
comment period announced at 70 FR 45370 (August 5,

[[Page 46823]]

2005) (notice). There were sixteen responders, and there was no 
consensus as to which of the four options to adopt. In addition, the 
restriction reform study concluded that a change to unity of invention 
under PCT Rule 13 under any of the four restriction reform options 
would significantly increase patent pendency. Thus, the Office is 
maintaining its current practices with respect to requirements for 
restriction under 35 U.S.C. 121 or unity of invention under PCT Rule 
13.
    Technology Center 1600 (biotechnology and organic chemistry) has 
implemented a comprehensive restriction training plan. This includes 
training examiners on proper restriction practices, including proper 
grouping of claims and rationale supporting the restriction 
requirement, using Art Unit and Work Group specific examples. Training 
has been ongoing, using materials that are published on the Office's 
Internet Web site. Feedback from the training to date has been 
incorporated into the initial patent examining training given to new 
hires.
    Although the Office will continue to assign divisional applications 
to the technology area most appropriate for the claimed subject matter, 
they are not necessarily assigned to the same examiner.
    Comment 309: Several comments asserted that restriction practice 
will increase as a result of the rule changes. One comment suggested 
that the Office needs to coordinate any changes in continuation 
practice with restriction reform. Another comment expressed the opinion 
that the proposed rule changes will exacerbate problems with the 
current restriction practice. One comment suggested that divisional 
application filings would likely drop in view of designating ten 
representative claims because examiners usually do not bother to make 
restriction requirements when they only have a few claims to examine. 
Another comment stated that an increase in restrictions is a desirable 
alternative to the rule changes. Another comment argued that current 
restriction practice adequately limits the claims for examination. The 
rules would complicate restriction practice resulting in multiple 
exchanges between the examiner and applicant when designated claims are 
subject to restriction.
    Response: The Office is not adopting the ``representative claims'' 
examination approach in this final rule. As noted previously, the 
Office received comments that restrictions would increase and comments 
that restrictions would decrease as a result of the changes to the 
rules. The changes being adopted in this final rule do not encourage 
more or fewer restrictions. Thus, the Office is maintaining its current 
practices with respect to requirements for restriction under 35 U.S.C. 
121 or unity of invention under PCT Rule 13. See Sec. Sec.  1.141, 
1.142, and 1.499.
    Comment 310: One comment suggested that the Office require all 
restriction requirements to be made within six months of filing, with 
no excess claim fees charge until after that period. Another comment 
stated that excess claims fees should only be determined after any 
restriction requirement has been made.
    Response: In fiscal year 2006, the average pendency to first Office 
action was 22.6 months for the entire Patent Examining Corps. 
Therefore, the Office's current first Office action pendency does not 
allow for an examination of the application to determine whether 
restriction is appropriate within six months of filing in most 
applications. Excess claims fees are required by the statutory 
requirement ``on filing or on presentation at any other time.'' See 35 
U.S.C. 41(a)(2). In response to a restriction requirement, applicant 
may file an amendment canceling the non-elected claims and request a 
refund of any excess claims fees paid on or after December 8, 2004, for 
the non-elected claims, if the amendment is filed before an examination 
on the merits has been made of the application. See Sec.  1.117.

K. Suggestions Relating to Legislative Changes

    Comment 311: A number of comments suggested that Congress should 
adequately fund the Office by making the United States Patent and 
Trademark Fee Modernization Act of 2005 (H.R. 2791, 109th Cong. (2005)) 
permanent and eliminating fee diversion. One comment also suggested 
that Congress provide additional funds (outside of fees collected) to 
the Office. A number of comments suggested that the fees for continued 
examination filings in excess of one should be increased (e.g., 
graduated fee schedule for subsequent filings). A number of comments 
suggested charging a fee for each priority claim made. One comment 
suggested that the fee would be proportional to the years of benefit 
requested. Several comments suggested that the current fee structure 
encourages continuations since it is cheaper to file multiple 
applications than to file a large number of claims (e.g., sixty total 
claims with nine independent claims) in a single application, and that 
the Office should revisit the fee structure if it wants to encourage 
filing the claims in a single application. A number of comments 
suggested that there should be higher fees on claims exceeding a 
certain minimal number, which is proportionate to the increased burden 
on the Office. One comment suggested permitting applicant to pay 
additional search and examination fees for those who want to submit 
more than ten representative claims. At least one comment suggested 
increasing fees based on complexity of the claims and art. One comment 
suggested that the Office should permit an applicant to file a third or 
subsequent continuing application with an appropriate higher fee. One 
comment suggested a three-tiered system: The first tier would allow 
three independent claims and twenty total claims; the second tier would 
activate a very high surcharge; and the third tier, in applications of 
more than ten independent and thirty total claims, would require a 
showing as to why such additional claims are necessary. Several 
comments suggested an overall general fee increase, especially for 
those areas with high workloads. One comment suggested that doubling 
the basic filing fee, search and examination fees would not be a 
hardship for applicants. Several comments suggested a number of changes 
to the fee schedule: Tripling fees for large entities; instituting a 
graduated fee scale for adding new matter rather than limiting the 
number of continuation-in-part applications; charging a higher filing 
fee for an application with greater than five claims and more than 1200 
words in the specification; raising fees if more than ten or more than 
twenty claims are submitted; increasing fees for independent claims in 
excess of three; increasing fees on all non-Jepson claims; and 
eliminating search and examination fees if an examination support 
document is submitted.
    Several comments stated that surcharges should be imposed on 
independent claims in excess of three and total claims in excess of 
twenty in order to address the problem of applications with excess 
numbers of claims. Several comments argued that the current fees appear 
to be having a significant impact in reducing the number of claims 
filed, that the Office has not fully evaluated that impact, and that 
the Office should give the fee increase more time to see if it will be 
effective.
    Response: Patent fees are primarily set by statute, and Congress 
has considerable authority in setting patent fees and funding of the 
Office. See Figueroa v. United States, 466 F.3d 1023, 1031-32, 80 
U.S.P.Q.2d 1437, 1443 (Fed. Cir. 2006). Thus, patent fee

[[Page 46824]]

and Office funding issues are beyond the scope of the proposed changes 
to the rules of practice.
    In 2002, the Office proposed a patent fee structure that included a 
graduated excess claims fees schedule and additional fees for 
continuing applications. The House Subcommittee on Courts, the 
Internet, and Intellectual Property held a hearing on July 18, 2002, at 
which patent user groups expressed strenuous opposition to the Office's 
2002 proposed patent fee structure. See The U.S. Patent and Trademark 
Office: Fee Schedule Adjustment and Agency Reform: Oversight Hearing 
Before the Subcommittee on Courts, the Internet, and Intellectual 
Property of the House Committee on the Judiciary, 107th Cong., 2nd 
Sess., Final Print Serial No. 92 (2002). The Office was unable to 
garner public support for a patent fee structure including a graduated 
excess claims fees schedule or any additional fees for continuing 
applications. Therefore, the patent fee structure proposed in the 
United States Patent and Trademark Fee Modernization Act of 2003 
(introduced as H.R. 1561) included the former ``flat'' excess claims 
fee schedule (with an adjustment to the fee amounts) and no additional 
fees for continuing applications.
    Section 801 et seq. of Division B of the Consolidated 
Appropriations Act, 2005, provided that 35 U.S.C. 41(a), (b), and (d) 
shall be administered in a manner that revises patent application fees 
(35 U.S.C. 41(a)) and patent maintenance fees (35 U.S.C. 41(b)) during 
fiscal years 2005 and 2006. See Public Law 108-447, 118 Stat. 2809 
(2004). In essence, the Consolidated Appropriations Act, 2005, made the 
patent fees set forth in the United States Patent and Trademark Fee 
Modernization Act effective during most of fiscal year 2005 and all of 
fiscal year 2006. The Revised Continuing Appropriations Resolution, 
2007 (Pub. L. 110-5, 121 Stat. 8 (2007)), kept the patent fee and fee 
structure provisions of the Consolidated Appropriations Act, 2005, in 
effect during fiscal year 2007.
    Moreover, the examination fee in effect under this legislation does 
not recover the entire cost of examination. The excess claims fee 
structure in effect under this legislation does not provide sufficient 
incentive for all applicants to keep the number of claims in an 
application at a reasonable number. The application filing fees in 
effect under this legislation provide no incentive for applicants to 
keep the number of continuing applications to a reasonable number. 
Thus, increasing fees, as suggested by many of the comments, is not, by 
itself, a sufficient solution for the large and growing backlog of 
unexamined applications.
    Comment 312: One comment suggested permitting applicants to pay an 
additional search fee for inventions that are restricted.
    Response: The Office studied such a proposal and determined that it 
would result in an unacceptable increase in patent pendency. See Green 
Paper Concerning Restriction Practice at 14-18 (2005). The Green Paper 
Concerning Restriction Practice is available on the Office's Internet 
Web site at: http://www.uspto.gov/web/patents/greenpaper.htm. Thus, the 
Office is not pursuing such a change to patent practice.
    Comment 313: One comment suggested that fees for small entities 
should be maintained and that fees for others should be increased.
    Response: The Office believes that Congress has set an appropriate 
discount for fees paid by small entities. 35 U.S.C. 41(h)(1) currently 
provides for a fifty percent reduction in patent fees charged under 35 
U.S.C. 41(a), (b), or (d)(1) for applicants who qualify as a small 
entity under 35 U.S.C. 41(h)(1), and 35 U.S.C. 41(h)(3) further 
provides a seventy-five percent reduction in the filing fee charged 
under 35 U.S.C. 41(a)(l)(A) for small entity applicants who file their 
applications electronically. The Office notes that small entity 
applicants file excess claims and continuing applications at virtually 
the same rate as other (non-small entity) applicants.
    Comment 314: One comment suggested that if a specification is a 
poor-quality literal or machine translation of a non-English language 
application, the examiner should be permitted to reject the 
specification as indefinite and provide a time period for applicant to 
provide a better quality translation.
    Response: The goal of the changes in this final rule is to increase 
quality and decrease pendency of patent applications. To assist the 
Office in meeting that goal, applicants should file applications that 
are in condition for examination, or provide corrections no later than 
the time they are taken up for examination. It should not be necessary 
for the Office to issue an Office action rejecting or objecting to an 
application due to informalities. However, if a specification is a poor 
quality literal translation of a non-English application, the examiner 
has the authority to object to the specification.
    Comment 315: One comment suggested that the Office adopt a 
``utility model'' type of patent as used in Australia in which a patent 
issues without a search being done, and a search is only conducted when 
the patent is enforced.
    Response: The Office is currently studying the concept of 
alternative types of patents, thus allowing an applicant to select a 
patent product based upon the applicant's needs. See Draft 2007-2012 
Strategic Plan (Objective 2 of Goal 1). A copy of the Office's draft 
proposed five-year (2007-2012) strategic plan can be found at http://www.uspto.gov/web/offices/com/strat2007/. However, implementing such a 
practice would need legislative changes.
    Comment 316: One comment indicated that Congress recently endorsed 
and expanded opportunities for double patenting via the CREATE Act 
(Cooperative Research and Technology Enhancement Act (Pub. L. 108-43, 
118 Stat. 3596 (2004)).
    Response: The legislative history of the CREATE Act (Cooperative 
Research and Technology Enhancement Act (Pub. L. 108-43, 118 Stat. 3596 
(2004)) indicates that Congress appreciated that the CREATE Act would 
result in additional double patenting situations. See H.R. Rep. No. 
108-425, at 6 (the Office may require a terminal disclaimer when double 
patenting is determined to exist for two or more claimed inventions for 
any application for which the applicant takes advantage of the ``safe 
harbor'' provision in 35 U.S.C. 103(c) as amended by the CREATE Act). 
Congress' acknowledgment of the possibility of double patenting is not, 
however, an expression of support for applicants to intentionally 
submit claims that would result in a double patenting situation. 
Instead, it shows that the Congress is aware of the problems created by 
multiple patents covering the same or substantially the same invention, 
and expects the Office to address these issues.
    Comment 317: Several comments suggested eliminating the two-year 
limit for filing a broadening reissue. One comment suggested amending 
the ``reissue'' or ``reexamination'' statute to permit broadening of 
claims at any time for a number of reasons such as: (1) To replace 
continuing applications which are now being filed to avoid the two-year 
statutory period for broadening patent claims; (2) to allow correction 
of simple drafting mistakes which may not be caught before the patent 
issues; and (3) to provide certainty to industry. The comment stated 
that to encourage participation by patentee, legal (as opposed to 
equitable) intervening rights should be provided that are linked to the 
date of the amendment. Also, such an amendment should provide for

[[Page 46825]]

intervening rights after eighteen months to patent applications as well 
as patents to put an end to the submarine patent situation.
    Response: The suggested changes to reissue or reexamination 
practice are not consistent with the Office's goals of increasing 
quality and reducing pendency. The Office, nevertheless, appreciates 
that continuing application practice may currently be used improperly 
to avoid the two-year bar and the broadening ``error'' requirement of 
the reissue statute (35 U.S.C. 251). The changes to continuing 
application practice in this final rule will reduce a patentee's 
ability to end-run the reissue statute via continuing application 
practice.
    Comment 318: One comment suggested instituting a tiered search and 
examination procedure, which provides for a refund of the examination 
fee if applicant decides to abandon the application after the search 
but before the examination. If applicants can save money by abandoning 
applications no longer deemed viable, applications will drop out of the 
application process, thereby freeing up valuable Office examination 
resources to focus on quality examination of the remaining 
applications, as well as reducing pendency.
    Response: The current fee legislation authorizes the Office to 
refund the search fee but not the examination fee if the applicant 
chooses not to pursue an application after it has been filed. See 35 
U.S.C. 41(d)(1)(D). This provision has been implemented in Sec.  
1.138(d). Under Sec.  1.138(d), applicant may file a petition for 
express abandonment before an examination has been made of the 
application to obtain a refund of the search fee and excess claims fee 
paid in the application. The feedback received by the Office indicates 
that the examination fee is too low to provide any additional incentive 
for an applicant to withdraw from the examination process and seek a 
refund.
    Comment 319: One comment suggested charging more money for 
voluminous IDS submissions, and additional surcharges for particular 
technologies where ``second pair of eyes'' review has had a significant 
impact on examination quality at an increased cost to the Office.
    Response: The Office is addressing the problem of large IDS 
submissions in a separate rule making. See Changes To Information 
Disclosure Statement Requirements and Other Related Matters, 71 FR at 
38812-16, 38820-22, 1309 Off. Gaz. Pat. Office at 27-31, 34-36. As for 
increasing fees for particular technologies where ``second pair of 
eyes'' review has had a significant impact on examination quality at an 
increased cost to the Office, Office funding is subject to 
appropriations by Congress, and charging additional fees will not 
necessarily provide more funding for the Office. See Figueroa, 466 F.3d 
at 1031, 80 U.S.P.Q.2d at 1442 (there is no requirement that the 
revenue resulting from patent fees be appropriated to fund the Office). 
Furthermore, the limitation currently facing the Office is not a lack 
of funds to hire new examiners, but rather the ability to hire and 
train new examiners in the numbers necessary to lower patent pendency 
while maintaining patent quality.
    Comment 320: One comment suggested modifying the relevant statutes 
to bar a continuing application or request for continued examination 
after thirty months from the filing date (other than a divisional 
application, which would be given a different period). The comment also 
indicated that continuation-in-part applications filed more than thirty 
months after the initial application should be barred under 35 U.S.C. 
102(b) based on the eighteen-month publication of the initial 
application.
    Response: First, the statutes cannot be modified without 
legislative action by Congress. Further, this final rule provides 
applicant sufficient opportunities to present claims during the 
prosecution of the initial application, two continuing applications, 
and a request for continued examination without justification. The 
prosecution of these applications and the request for continued 
examination will most likely extend more than thirty months from the 
earliest claimed filing date, particularly in certain areas such as 
biotechnology. The changes as adopted in this final rule appropriately 
balance an applicant's need for opportunities to present claims and the 
Office's need to utilize its examining resources more efficiently to 
reduce the backlog of unexamined applications and improve quality.
    Comment 321: One comment suggested developing a practice where new 
matter can be added to an existing application with a request for 
continued examination. The comment explained such a practice would 
eliminate the need to file continuation-in-part applications, would not 
take the application out of the examining queue, and would be more 
efficient because the same examiner, rather than different examiners, 
would examine the application, and would also avoid double patenting 
issues.
    Response: A request for continued examination is not a new 
application, but is instead a means to continue examination of an 
existing application. Thus, such a change could not be made, because 35 
U.S.C. 132(a) prohibits introduction of new matter into an application. 
Furthermore, even if 35 U.S.C. 132(a) did not prohibit such a practice, 
such a practice would create problems in determining the filing date of 
the new matter.
    Comment 322: One comment suggested that the Office should seek the 
authority from Congress to limit the number of claims in any particular 
application.
    Response: The Office is not seeking to limit the number of claims 
in an application. Instead, the Office aims to improve the quality of 
examination. The changes to Sec.  1.75 in this final rule permit an 
applicant to present up to five independent claims and twenty-five 
total claims in the application without submitting an examination 
support document in compliance with Sec.  1.265. The changes to Sec.  
1.75 in this final rule also permit an applicant to present more than 
five independent claims or more than twenty-five total claims if the 
applicant submits an examination support document in compliance with 
Sec.  1.265. If an examination support document in compliance with 
Sec.  1.265 is not filed before the issuance of a first Office action 
on the merits of the application, the application may not contain or be 
amended to contain more than five independent claims or more than 
twenty-five total claims. Thus, the changes being adopted in this final 
rule are not placing a limit on the number of claims.
    Comment 323: One comment suggested that the Office should permit 
all claims to be filed in an application without any excess claims 
fees, and then after restrictions are made, calculate the needed fee 
for ``additional claims'' so applicants are not penalized by paying 
claims fees twice.
    Response: An applicant can request a refund for excess claims 
canceled prior to a first action on the merits. See Sec.  1.117. Thus, 
an applicant does not need to pay claim fees twice, if applicant 
cancels the non-elected claims in reply to a restriction requirement.
    Comment 324: One comment suggested providing for the addition of 
dependent claims after allowance for a reduced fee with the requirement 
that applicant identify support for the claims in the specification.
    Response: The comment did not provide an explanation as to how such 
a strategy would reduce pendency and promote quality. Even assuming

[[Page 46826]]

applicant would file less claims under this suggested practice, 
examination of the newly added claims after allowance would be 
required. Thus, it is not clear how the suggested strategy would serve 
these goals more effectively than the changes being adopted in this 
final rule.
    Comment 325: One comment suggested to bar, by statute, more than 
three independent claims and ten total claims, provided that amendments 
may be made in the regular course of prosecution and after grant to end 
claim gaming. The comment further indicated that the proposed rule 
changes will be subject to administrative challenge, leading to several 
years of uncertainty and chaos.
    Response: A number of comments indicated that there are situations 
in which more than three independent claims and more than ten total 
claims are needed. Thus, the Office recognizes that it would be 
inappropriate to seek such legislation to place an absolute limit on 
the number of claims at this juncture.
    Comment 326: One comment suggested that reducing the filing and 
maintenance fees would reduce filings. The comment stated that the 
backlog has gotten so large due to the increases in excess claims fees, 
there has been a tendency among practitioners to segment applications 
into multiple related filings, each having twenty or so claims. This 
segmenting, the comment explains, has significantly increased the 
number of filings within the Office.
    Response: It is unclear how reducing fees would reduce the number 
of filings. The experience of the Office is that reducing patent fees 
would not lead to reduced filings.
    Comment 327: One comment suggested including a patent term 
reduction while an application remains pending.
    Response: Section 1.704 currently provides for reduction of patent 
term adjustment for processing delays attributable to the applicant.
    Comment 328: One comment suggested moving to a first-to-file 
system.
    Response: As part of global patent law harmonization efforts, the 
Office has sought public comment on whether the first to invent (used 
in the United States) or the first inventor to file (used in the 
remainder of the world) standard in determining the right to a patent 
represented a ``best practice'' for a harmonized global patent system. 
See Request for Comments on the International Effort to Harmonize the 
Substantive Requirements of Patent Laws, 66 FR 15409 (Mar. 19, 2001) 
(request for comments). The Office is continuing to consider the issues 
related to the first to invent versus the first inventor to file 
standard in determining the right to a patent in the context of 
international harmonization efforts.
    Comment 329: One comment suggested elimination of all forms of 
continuing applications except divisional applications.
    Response: The changes to continuing application practice adopted in 
this final rule seek a balanced approach between the needs of 
applicants for patents and the goals of the Office to increase quality 
and decrease pendency.
    Comment 330: One comment suggested reducing the shortened statutory 
period for an applicant's response to three months without any 
extension of time. One comment suggested implementing a thirty-day 
reply period for both the Office and applicants.
    Response: The Office is considering whether it should change the 
shortened statutory period for Office actions on the merits to less 
than three months.
    Comment 331: Several comments expressed support for publication of 
all applications. One comment suggested limiting secrecy of a patent 
application to one month. One comment suggested that some form of 
intervening rights legislation might better address the problem of 
repetitive filings. One comment suggested elimination of 35 U.S.C. 
135(b). One comment suggested amending 35 U.S.C. 271 so that a variety 
of claim forms are not necessary for direct infringement to be found, 
arguing that current 35 U.S.C. 271 is the reason why software-based 
inventions require claims to different statutory classes, thus 
increasing the number of claims in an application. One comment 
suggested that the Office should work with Congress to legislatively 
overturn Honeywell Int'l Inc. v. Hamilton Sundstrand Corp., 370 F.3d 
1131, 71 U.S.P.Q.2d 1065 (Fed. Cir. 2004), to promote the use of 
dependent claims and not construe the rewriting of an objected to 
dependent claim in independent form narrowly under the doctrine of 
equivalents. One comment suggested granting rights to regulate the use 
of an Internet patent to the assignee and the enforcement of such 
regulation would be based on a fee and would not include the right to 
prevent others from using the invention.
    Response: The changes suggested by the comments are beyond the 
scope of the proposed changes to the rules of practice. It is not 
clear, however, how the changes suggested by the comments would address 
the increased usage of continuing application practice or have an 
appreciable impact on quality or pendency.

L. Effective Date of the Changes in This Final Rule

    Comment 332: One comment stated that the Office does not have any 
authority to promulgate retroactive rules because the Administrative 
Procedures Act does not confer such power on the Office. Several 
comments asserted that Congress never expressly authorized the Office 
to promulgate retroactive rules, citing Landgraf v. USI Film Prods., 
511 U.S. 244, 265 (1994) and Bowen v. Georgetown Univ. Hosp., 488 U.S. 
204, 208 (1988). A number of comments also suggested that the 
retroactive effect of proposed rule Sec.  1.78 is contrary to judicial 
precedent, citing Henriksen and Hogan. Several comments argued that 
applying the changes to Sec.  1.75 retroactively would be unfair to the 
applicants and a violation of due process because applicants were not 
given sufficient notice of the changes when they filed applications. 
Lastly, one comment argued that applying the rule changes to pending 
applications is an unconstitutional denial of due process.
    Response: The Office is not engaging in retroactive rule making. 
This final rule has a prospective effect only. The Office's decision to 
grandfather only pending applications in which a first Office action on 
the merits was mailed before November 1, 2007 (the effective date of 
the changes in this final rule) with respect to the changes to Sec.  
1.75 does not constitute retroactive rule making. Likewise, the 
Office's decision to grandfather only continuing applications and 
requests for continued examination that were filed before the effective 
date of the final rule with respect to Sec. Sec.  1.78 and 1.114 (with 
a provision that allows for at least ``one more'' continuation 
application or continuation-in-part application of an application filed 
before the publication date of this final rule) does not constitute 
retroactive rule making.
    ``A statute [or regulation] does not operate `retroactively' merely 
because it is applied in a case arising from conduct antedating the 
statute's enactment.'' Landgraf, 511 U.S. at 255. Rather, a statute (or 
regulation) is retroactive if it takes away or impairs vested rights 
acquired under existing law, creates a new obligation, imposes a new 
duty, or attaches a new disability with respect to transactions already 
completed. See Landgraf, 511 U.S. at 269. The filing of an application 
for patent does not create a vested right or amount to a transaction 
already completed. See Community TV, Inc. v. FCC, 216 F.3d 1133, 1143 
(D.C.

[[Page 46827]]

Cir. 2000) (the Federal Communications Commission is free to alter the 
criteria for consideration of pending ``upgrade'' applications because 
the mere filing of an application does not vest the applicant with a 
legally cognizable expectation interest); Chadmore Communs. v. FCC, 113 
F.3d 235, 240-41 (D.C. Cir. 1997) (the mere filing of an application 
does not vest an applicant with a legally cognizable expectation 
interest). In addition, the Office is not changing the substantive 
criteria of patentability. The Office is simply revising the procedures 
an applicant must follow for presenting more than five independent 
claims or more than twenty-five total claims in an application, and for 
seeking continued examination of an application via a continuation 
application, continuation-in-part application, or a request for 
continued examination. See Landgraf, 511 U.S. at 275 (changes in 
procedural rules may generally be applied in actions arising before the 
change without raising retroactivity concerns).
    Finally, this final rule does not raise constitutional due process 
concerns. This rule change does not preclude an applicant from filing 
an application or receiving a patent containing any number of claims. 
Rather, the changes to Sec.  1.75 in this final rule simply revise the 
procedures for presenting more than five independent claims or more 
than twenty-five total claims. As for the changes to Sec.  1.78 in this 
final rule, the filing of an application does not vest an applicant 
with a due process right to obtain continued examination via a 
continuation application, continuation-in-part application, or a 
request for continued examination for purposes of presenting 
amendments, arguments, or evidence that could have been submitted prior 
to close of prosecution in the initial application (or the prior-filed 
application).
    Comment 333: A number of comments suggested that the Office should 
not retroactively affect any pending applications when adopting the 
changes to Sec.  1.78. Specifically, the comments disagreed with the 
Office's decision to apply the changes to Sec.  1.78 to any 
applications filed on or after the effective date of the final rule, 
which would result in an applicant being able to file only one 
continuation or continuation-in-part application (and not ``one more'' 
continuation or continuation-in-part application) on or after the 
effective date of the final rule without meeting the requirements 
specified in Sec.  1.78(d)(1)(i) or (d)(1)(iii) or including a petition 
under Sec.  1.78(d)(1). The comments argued that the changes would 
retroactively affect the prosecution of many pending applications, 
particularly those that are continued examination filings, precluding 
any opportunity for subsequent continued examination filings. A number 
of comments also argued that retroactively affecting the pending 
applications would be unfair to applicants because it would deprive 
applicants of timely notice of the rule changes and it would be a 
violation of due process. Several comments argued that retroactively 
affecting the pending applications would require applicants to review 
the pending applications to determine whether to file additional 
continuing applications to preserve the patent rights of unclaimed 
subject matter or restricted inventions and to file many continuing 
applications before the effective date. The comments further argued 
that this would increase the cost of prosecution and the Office's 
backlog of applications. One comment estimated the cost of reviewing 
the pending applications to be 180 million dollars based on 600,000 
pending applications. A number of the comments suggested that the 
changes should be applicable only to claiming the benefit of 
applications filed on or after the effective date (i.e., the changes 
should be applicable only to non-continuing applications filed on or 
after the effective date). One comment suggested that the changes to 
Sec.  1.78 should apply to applications filed on or after the effective 
date with an exception for any applications that have a filing date 
earlier than one year from the effective date. One comment suggested 
that in the determination of the number of continued examination 
filings permitted without a petition and a showing, the Office should 
count only the continued examination filings filed on or after January 
3, 2006. One comment suggested that the Office should permit applicants 
to file one more continued examination filing on or after the effective 
date.
    Response: This final rule provides that an applicant is not 
required to meet the requirements set forth in Sec.  1.78(d)(1) if: (1) 
The application claims the benefit under 35 U.S.C. 120, 121, or 365(c) 
only of nonprovisional applications or international applications filed 
before the publication date of this final rule in the Federal Register; 
and (2) there is no other application filed on or after the publication 
date of this final rule in the Federal Register that also claims the 
benefit under 35 U.S.C. 120, 121, or 365(c) of such prior-filed 
nonprovisional applications or international applications. This will 
provide applicants with ``one more'' continuation application or 
continuation-in-part application of an application that was filed prior 
to the publication date of this final rule in the Federal Register 
without a petition and showing. Thus, applicants are also permitted to 
file a divisional application in compliance with Sec.  1.78(d)(1)(ii) 
of an application that was filed prior to the effective date of this 
final rule without a petition and showing.
    The rules of practice currently provide that by presenting any 
paper (including any continuation application, continuation-in-part 
application, or request for continued examination) to the Office, the 
party presenting the paper is certifying that to the best of the 
party's knowledge, information and belief, formed after an inquiry 
reasonable under the circumstances, that the paper is not being 
presented for any improper purpose, such as to harass someone or to 
cause unnecessary delay or to needlessly increase the cost of 
prosecution before the Office. See Sec.  10.18(b)(2)(i). Thus, as part 
of the reasonable inquiry, the Office expects a party to review 
applications to ensure that the desired amendments, arguments, or 
evidence that can be submitted during the prosecution of the prior-
filed (or before the close of prosecution in the) application are 
submitted rather than waiting to make such submission in a later-filed 
continuation application. Therefore, it is unclear why the final rule 
would impose any significant additional cost on applicants.
    Comment 334: Several comments suggested that if the Office adopts 
the proposed changes to Sec.  1.78, the Office should publish the final 
rule well in advance of the effective date to provide sufficient time 
for applicants to adjust their prosecution strategies in any pending 
applications. A few comments further suggested a time period of six 
months to one year between the publication of the final rule and the 
effective date. Furthermore, a few comments suggested that the changes 
to Sec.  1.78 should be implemented in phases. One of the comments 
provided an example that the changes would initially apply only to non-
continuing applications filed on or after the effective date, and then 
six months after the effective date, the changes would apply to 
applications that have an effective filing date more than four years 
before the effective date.
    Response: This final rule has been published well (more than sixty 
days) in advance of the November 1, 2007, effective date of the changes 
in this final rule. As previously discussed, this final rule permits 
applicants to file ``one

[[Page 46828]]

more'' continuation or continuation-in-part application of an 
application that was filed prior to the publication date of this final 
rule in the Federal Register without a petition and showing, and to 
file (at least) ``one more'' divisional application in compliance with 
Sec.  1.78(d)(1)(ii) of an application that was filed prior to the 
effective date of this final rule without a petition and showing. The 
Office published the Continuing Applications Proposed Rule and the 
Claims Proposed Rule in the Federal Register on January 3, 2006, which 
set forth proposed changes to the practice for continued examination 
filings, patent applications containing patentably indistinct claims, 
and examination of claims in patent applications. Applicants have been 
provided with a time period of more than one and a half years from the 
publication date of the proposed rules to the effective date of this 
final rule, and a time period of more than sixty days from the 
publication of the final rule to the effective date. Therefore, 
applicants should have sufficient advance notice of the rule changes.
    Comment 335: One comment suggested a transitional practice for 
divisional applications, permitting benefit claims to be added only to 
applications filed on or before the effective date in serial divisional 
applications.
    Response: Section 1.78(d)(1)(ii) as adopted in this final rule 
permits an applicant to file a divisional application of an application 
for the claims to a non-elected invention that has not been examined if 
the application was subject to a requirement for restriction. The 
divisional application need not be filed during the pendency of the 
application subject to a requirement for restriction, as long as the 
copendency requirement of 35 U.S.C. 120 is met. Thus, applicant may 
file the divisional application during the pendency of the application 
that was subject to a requirement for restriction or the pendency of 
any continuing application of such an application.
    Comment 336: A number of comments suggested that the changes to 
Sec.  1.75 should apply only to applications filed on or after the 
effective date. A number of comments disagreed with the Office's 
decision to apply the changes to Sec.  1.75 to applications filed 
before the effective date. Several comments further argued that the 
cost of ``retroactively'' applying the rule changes would be enormous 
to applicants, especially to small entities, because most applicants 
would be required to review their pending applications for compliance 
with the new requirement. Several comments estimated the cost to be 100 
to 120 million dollars to designate representative claims in pending 
applications, and one comment estimated the cost to be 180 million 
dollars. Several comments argued that small entities are less able to 
absorb expenses associated with reviewing and revising pending 
applications. This could prevent small entities from prosecuting 
pending applications. Several comments argued that because applicants 
already paid the increased claims fees under the Consolidated 
Appropriations Act, 2005, in the pending applications for the Office to 
examine all of the claims, the new requirements would constitute a 
taking by the Federal Government. Several comments also argued that 
applicants did not anticipate the additional costs in reviewing and 
amending the applications for compliance with the new requirements.
    Response: The Office has revised Sec.  1.75 to provide that if an 
application contains more than five independent claims or more than 
twenty-five total claims, the applicant must submit an examination 
support document in compliance with Sec.  1.265. Of the applications 
currently awaiting examination for which claim data is available in 
PALM (which is over ninety percent of the applications for which 
preexamination processing is complete), about thirty percent contain 
more than five independent claims or more than twenty-five total 
claims. Therefore, the Office's decision to grandfather only pending 
applications in which a first Office action on the merits was mailed 
before November 1, 2007 (the effective date of the changes in this 
final rule) with respect to the changes to Sec.  1.75 will not affect 
the majority of applications that are currently pending before the 
Office. In addition, the changes in this final rule do not preclude an 
applicant from filing an application or obtaining a patent containing 
any number of claims, but simply changes the procedures for 
applications containing more than five independent claims or more than 
twenty-five total claims. Therefore, there is no support for the 
proposition that the changes in this final rule amount to a ``taking'' 
by the government. Additionally, Sec.  1.117 as adopted in this final 
rule provides that if an amendment canceling a claim is filed before an 
examination on the merits has been made of the application, the 
applicant may request a refund of any excess claims fee paid on or 
after December 8, 2004 (fees paid under the Consolidated Appropriations 
Act), for such claim.
    Comment 337: One comment suggested that if the changes to Sec.  
1.75 are retroactively applied to applications filed before the 
effective date, the Office should automatically consider certain claims 
as representative when applicant fails to designate claims within the 
time period set forth in a notice requiring the designation of 
representative claims. One comment inquired about requiring applicants 
to take action on applications in the backlog within the first month 
following enactment of the proposed rules. One comment suggested that 
the Office should send a notice giving applicant three months 
(extendable to six months) within which to designate the representative 
claims in each pending application and, if necessary, to file an 
examination support document.
    Response: As discussed previously, this final rule does not adopt 
the ``representative claims'' examination approach. Under this final 
rule, applicant is permitted to present more than five independent 
claims or more than twenty-five total claims if applicant files an 
examination support document before a first Office action on the merits 
of an application. The Office does not expect that most applicants will 
need to take any action to comply with the changes to Sec.  1.75 in 
this final rule within the first month following the effective date of 
this final rule because the majority of applications contain five or 
fewer independent claims and twenty-five or fewer total claims. The 
Office will provide an applicant who filed a nonprovisional application 
under 35 U.S.C. 111(a) before November 1, 2007, or a nonprovisional 
application that entered the national stage after compliance with 35 
U.S.C. 37 before November 1, 2007, and who would be affected by the 
changes in the final rule, with an opportunity to submit: (1) An 
examination support document; (2) a new set of claims such that the 
application contains five or fewer independent claims and twenty-five 
or fewer total claims; or (3) a suggested restriction requirement. 
Specifically, the Office will issue a notice setting a two-month time 
period that is extendable under Sec.  1.136(a) or (b) within which the 
applicant must exercise one of these options in order to avoid 
abandonment of the application. The Office, however, may combine such a 
notice with a requirement for restriction, in which case the applicant 
must make an election responsive to the restriction requirement and, if 
there are more than five independent claims or more than twenty-five 
total claims drawn to the elected invention, the applicant must

[[Page 46829]]

also: (1) File an examination support document in compliance with Sec.  
1.265; or (2) amend the application such that it contains five or fewer 
independent clams and twenty-five or fewer total claims drawn to the 
elected invention. Thus, if such a notice is combined with a 
requirement for restriction, the applicant does not have the option of 
replying to such notice with a suggested restriction requirement under 
Sec.  1.142(c).

M. Miscellaneous

    Comment 338: One comment suggested that the changes to Sec.  1.78 
are contrary to the purpose of the Bayh-Dole Act.
    Response: The Bayh-Dole University and Small Business Patent 
Procedures Act (Pub. L. 96-517, 94 Stat. 3015-28 (codified at 35 U.S.C. 
200 et seq.)), concerns patent rights in inventions made with federal 
assistance. Specifically, 35 U.S.C. 200 provides that:

     ?>It is the policy and objective of the Congress to use the 
patent system to promote the utilization of inventions arising from 
federally supported research or development; to encourage maximum 
participation of small business firms in federally supported 
research and development efforts; to promote collaboration between 
commercial concerns and nonprofit organizations, including 
universities; to ensure that inventions made by nonprofit 
organizations and small business firms are used in a manner to 
promote free competition and enterprise without unduly encumbering 
future research and discovery; to promote the commercialization and 
public availability of inventions made in the United States by 
United States industry and labor; to ensure that the Government 
obtains sufficient rights in federally supported inventions to meet 
the needs of the Government and protect the public against nonuse or 
unreasonable use of inventions; and to minimize the costs of 
administering policies in this area.

    The changes to Sec.  1.78 adopted in this final rule do not concern 
patent rights in inventions made with federal assistance and do not 
impinge upon any of the policies or objectives set forth in 35 U.S.C. 
200. The changes in this final rule do not treat patent applications 
resulting from federally supported research differently from other 
patent applications. The policy objectives of the Bayh-Dole Act do not 
encourage or condone more favorable treatment of patent applications 
resulting from federally supported research. See Univ. of Rochester v. 
G.D. Searle & Co., 358 F.3d 916, 929, 69 U.S.P.Q.2d 1886, 1896 (Fed. 
Cir. 2004) (none of the eight policy objectives of the Bayh-Dole Act 
encourages or condones less stringent application of the patent laws to 
universities than to other entities).
    Comment 339: A number of comments suggested that to help reduce the 
backlog of pending applications the Office should provide a procedure 
under which an applicant may request deferral of examination of the 
application.
    Response: The rules of practice currently have a procedure under 
which an applicant may request deferral of examination. Specifically, 
Sec.  1.103(d) permits deferral of examination for up to three years 
from the earliest filing date for which a benefit is claimed under 
title 35, United States Code. The Office publishes any application in 
which a deferral of examination under Sec.  1.103(d) is requested. The 
entire period of deferral is a reduction under Sec.  1.704(c)(1) of any 
patent term adjustment.
    Comment 340: A number of comments suggested variations of the 
deferral of examination procedure under Sec.  1.103(d), including, 
inter alia, providing for automatic deferral of examination, extending 
the period of deferral, allowing third party requests for examination 
of deferred applications, eliminating any negative impact on patent 
term adjustment resulting from deferral, adopting deferral of 
examination procedures used in other countries such as Japan and 
Canada, tying the period of deferral to the actual filing date of the 
application rather than the claimed benefit date, and establishing 
deferral fees based on the length of deferral.
    Response: The deferral of examination procedure set forth in Sec.  
1.103(d) was used in fewer than two hundred applications since November 
29, 2000 (the effective date of Sec.  1.103(d)). The Office did not 
propose any changes to the deferral of examination procedure in the 
notices of proposed rulemaking published on January 3, 2006, in the 
Federal Register. In view of the comments received on the deferral of 
examination procedure, the Office is studying whether changes (e.g., 
the maximum deferral period, third party request for examination, and 
patent term adjustment) to the deferral of examination procedure would 
be appropriate.
    Comment 341: Several comments opposed third party participation, 
but suggested that the Office could move toward providing a post-grant 
opposition period, similar to that currently offered in Europe, during 
which the public could oppose issued patents and make prior art 
submissions so the patent could receive a post-grant review.
    Response: Legislation regarding post-grant opposition and related 
participation by third parties is currently pending before Congress. If 
enacted, the Office will implement the legislation accordingly.
    Comment 342: A number of comments suggested expanding the 
opportunity under Sec.  1.99 for third parties to submit prior art 
references in applications; for example, up to a first Office action.
    Response: The Office has proposed changes to Sec.  1.99 that would 
extend the period for submission of information from two months after 
pre-grant publication of the application to six months after pre-grant 
publication of the application, or mailing of a notice of allowance, 
whichever occurs first. See Changes To Information Disclosure Statement 
Requirements and Other Related Matters, 71 FR at 38816, 38822, 1309 
Off. Gaz. Pat. Office at 31, 36.
    Comment 343: One comment questioned applicant's recourse if a third 
party submission was filed in his or her application.
    Response: Applicant's recourse would be the same as it currently is 
when a third party submits patents or publications pursuant to Sec.  
1.99 in a published patent application. Applicant will have an 
opportunity to comment on any patents or publications relied upon by 
the examiner in a rejection of applicant's claims. Note, however, 35 
U.S.C. 122(c) prohibits third party protests.
    Comment 344: Several comments suggested that prior art submissions 
by third parties should be required to conform to current information 
disclosure statement rules. These comments also suggested that either 
statements of relevance for each submitted document, or arguments why 
the claims are unpatentable in view of the cited documents, should 
accompany the submissions.
    Response: Prior to the publication of a patent application, a third 
party may file prior art submissions in compliance with the 
requirements of Sec.  1.291 in the application. After the publication 
of the application, Sec.  1.99 only permits a third party to file up to 
ten patents or publications per submission. Section 1.99 does not 
permit the third party to file comments regarding the documents, or 
comments regarding the patentability of the claims in view of the 
documents. Additionally, permitting a third party to file an 
explanation of relevance would rise to the level of a protest, which is 
prohibited by 35 U.S.C. 122(c).
    Comment 345: Several comments suggested allowing a third party to 
request examination of an application upon paying a fee during a time 
frame such as between thirty-six and forty-

[[Page 46830]]

eight months from the application filing date. One comment suggested 
permitting third parties to request accelerated examination of long-
pending applications by submitting documents required for accelerated 
examination.
    Response: Under the current patent laws and regulations, it is not 
proper for a third party to be involved in the examination of an 
application owned by another which includes seeking to accelerate the 
examination of an application that is properly awaiting its turn to be 
examined. Permitting a third party to advance prosecution of an 
application may be considered in the future for those instances in 
which an applicant has requested deferral of the examination. However, 
at this time, the Office has not elected to amend Sec.  1.103(d) to 
permit such action, in order to further study the issue and to provide 
the public additional opportunity to comment.
    Comment 346: One comment suggested the use of authorized third 
party prior art searches.
    Response: Patents or publications filed by a third party in 
compliance with Sec.  1.99 may be entered in the file of a published 
application. Examiners may use any of these references in a rejection, 
if appropriate.
    Comment 347: Several comments were critical of the Office's 
position that the proposed changes to the practice for continuing 
applications, request for continued examination, and applications 
containing patentably indistinct claims will not create any additional 
work for the applicant.
    Response: The changes being adopted in this final rule will not 
require any additional submissions for the majority of patent 
applications. Prosecution, however, may be more compact since the 
number of continuing applications and requests for continued 
examination permitted without any justification is being limited. 
Nevertheless, the changes being adopted in this final rule will result 
in more effective and efficient examination without any additional work 
on the part of the majority of applicants.
    Comment 348: Several comments recommended that the Office should 
conduct a public hearing before adopting the rule changes. One comment 
suggested that the Office should issue a green paper or advance notice 
of proposed rule making to receive more input and perform a cost-
benefit analysis on the rule changes. One comment recommended that the 
Office should form a patent practice advisory committee, consisting of 
volunteers from the patent bar, for the purpose of studying problems 
experienced by the Office and proposing solutions that would be 
tailored to address those problems. The comments recommended that the 
Office should bring together all the relevant parties, including the 
Office, patent practitioners, patentees, litigators, and judges, to 
arrive at a solution that benefits all parties in the patent system.
    Response: 35 U.S.C. 2(b)(2)(B) directs the Office to follow the 
procedures set forth in 5 U.S.C. 553 in adopting changes to the rules 
of practice, and 35 U.S.C. 3(a)(2)(B) directs the Office to consult 
with the Patent Public Advisory Committee when proposing or adopting 
changes to the rules of practice that change user fees or are subject 
to notice and comment under 5 U.S.C. 553. The Office published notices 
of proposed rule making pursuant to 5 U.S.C. 553(b) in advance of this 
final rule, provided an extended comment period to give interested 
persons an opportunity to submit written data, views, or arguments 
pursuant to 5 U.S.C. 553(c), and has published this final rule at least 
thirty days in advance of its effective date pursuant to 5 U.S.C. 
553(d). The Office also consulted with the Patent Public Advisory 
Committee prior to publishing the notices of proposed rule making and 
this final rule. The Office also conducted four public meetings to 
obtain feedback from the public on the proposed changes which resulted 
in the changes being adopted in this final rule: (1) The first in 
Chicago, Illinois, on February 1, 2006; (2) the second in Berkeley, 
California, on February 28, 2006; (3) the third in Houston, Texas, on 
March 22, 2006; and (4) the fourth in Alexandria, Virginia (at the 
Office's Carlyle campus) on April 25, 2006. The number of comments 
submitted in response to the notices of proposed rule making indicates 
that interested persons and organizations have been given ample 
opportunity to provide input on the changes being adopted in this final 
rule.

IV. Rule Making Considerations

A. Administrative Procedure Act

    This notice adopts changes to the rules of practice that concern 
the process for applying for a patent, namely, continuing applications 
and requests for continued examination practices, the treatment of 
applications containing more than a set number of independent or total 
claims, and the treatment of multiple applications containing 
patentably indistinct claims. The changes being adopted in this notice 
do not change the substantive criteria of patentability and do not 
effectively foreclose the applicant's opportunity to make a case on the 
merits (i.e., the changes being adopted in this final rule continue to 
provide patent applicants with numerous opportunities). Therefore, 
these rule changes involve interpretive rules, or rules of agency 
practice and procedure. See Bachow Communs., Inc. v. FCC, 237 F.3d 683, 
690 (DC Cir. 2001) (rules governing an application process are ``rules 
of agency organization, procedure, or practice'' and exempt from the 
Administrative Procedure Act's notice and comment requirement); see 
also Fressola v. Manbeck, 36 USPQ2d 1211, 1215 (D.D.C. 1995) (``it is 
extremely doubtful whether any of the rules formulated to govern patent 
or trade-mark practice are other than `interpretive rules, general 
statements of policy, * * * procedure, or practice.' '') (quoting C.W. 
Ooms, The United States Patent Office and the Administrative Procedure 
Act, 38 Trademark Rep. 149, 153 (1948)). Accordingly, prior notice and 
an opportunity for public comment were not required pursuant to 5 
U.S.C. 553(b)(A) (or any other law), and thirty-day advance publication 
is not required pursuant to 5 U.S.C. 553(d) (or any other law). 
Nevertheless, the Office sought public comment on proposed changes to 
these rules of practice to obtain the benefit of such input prior to 
adopting the changes to the rules of practice in this final rule.

B. Regulatory Flexibility Act

    As prior notice and an opportunity for public comment are not 
required pursuant to 5 U.S.C. 553 (or any other law), neither a 
regulatory flexibility analysis nor a certification under the 
Regulatory Flexibility Act (5 U.S.C. 601 et seq.) are required. See 5 
U.S.C. 603. Nevertheless, the Office published notices of proposed rule 
making setting forth the factual basis for certification under the 
Regulatory Flexibility Act and sought public comment on that 
certification. See Changes to Practice for the Examination of Claims in 
Patent Applications, 71 FR at 66, 1302 Off. Gaz. Pat. Office at 1333, 
and Changes to Practice for Continuing Applications, Requests for 
Continued Examination Practice, and Applications Containing Patentably 
Indistinct Claims, 71 FR at 56-57, 1302 Off. Gaz. Pat. Office at 1325. 
For the reasons set forth herein, the Deputy General Counsel for 
General Law of the United States Patent and Trademark Office has 
certified to the Chief Counsel for Advocacy of the Small Business 
Administration that the changes in this final rule will not have a 
significant economic impact on a

[[Page 46831]]

substantial number of small entities. See 5 U.S.C. 605(b).
    This final rule provides that: (1) A third or subsequent 
continuation or continuation-in-part application or any second or 
subsequent request for continued examination must include a showing as 
to why the amendment, argument, or evidence sought to be entered could 
not have been submitted prior to the close of prosecution after a first 
and second continuation or continuation-in-part application and a 
request for continued examination; (2) any divisional application be 
the result of a requirement to comply with the requirement of unity of 
invention under PCT Rule 13 or a requirement for restriction under 35 
U.S.C. 121 in the prior-filed application; (3) an application that 
contains or is amended to contain more than five independent claims or 
more than twenty-five total claims must include an examination support 
document under 37 CFR 1.265 that covers each claim (whether in 
independent or dependent form) before the first Office action on the 
merits; and (4) multiple applications that have the same claimed filing 
or priority date, substantial overlapping disclosure, a common 
inventor, and a common assignee include either an explanation as to how 
the claims are patentably distinct, or a terminal disclaimer and 
explanation as to why patentably indistinct claims have been filed in 
multiple applications.
    In response to the Office's certification in the notices of 
proposed rule making, the Small Business Administration Office of 
Advocacy (SBA-Advocacy) submitted a comment contending that the 
proposed changes are likely to have a significant economic impact on a 
substantial number of small entities, including small businesses and 
small independent inventors. SBA-Advocacy recommended that the Office 
conduct a supplemental Initial Regulatory Flexibility Analysis before 
publishing a final rule.
    The Office's analysis of the proposed rules indicated that the 
rules would not have a significant economic impact on a substantial 
number of small entities. The Office considered all public comments 
addressing small entities, including those submitted by SBA-Advocacy. 
In response to these comments, this final rule incorporates a number of 
revisions designed to further reduce the number of small entities 
affected by the changes and the impacts on small entities. These 
changes in this final rule vis-[aacute]-vis the proposed rules that 
reduce small entity impacts are as follows: (1) This final rule adopts 
an examination support document requirement threshold of five 
independent claims or twenty-five total claims, rather than ten 
representative claims; (2) this final rule provides that small entities 
as defined by the Regulatory Flexibility Act are exempt from the 
requirement that an examination support document must, for each cited 
reference, include an identification of all of the limitations of each 
of the claims that are disclosed by the reference; (3) this final rule 
adopts a continued examination filing petition threshold of two 
continuing applications (continuation or continuation-in-part 
applications), plus a request for continued examination in any one of 
the initial or two continuing applications, rather than one 
continuation application, continuation-in-part application, or request 
for continued examination; (4) this final rule does not require that a 
divisional application be filed during pendency of initial application; 
and (5) this final rule provides for at least ``one more'' continuation 
or continuation-in-part application after the effective date, 
regardless of the number of previous continued examination filings.
    In addition, the Office commissioned a detailed analysis of the 
impacts of this final rule on small entities. The analysis concludes 
that this final rule is not expected to result in a significant 
economic impact on a substantial number of small entities. The analysis 
measured economic impact in terms of annualized incremental cost as a 
percentage of revenue. The analysis indicated that the incremental cost 
(not annualized) would be between $2,563 and $13,121 for an entity who 
would be required to file an examination support document, a petition 
for an additional continued examination filing, or both. The analysis 
presumed that an economic impact greater than three percent of 
annualized incremental cost as a percentage of revenue was a 
significant impact. The analysis indicated that no small entities fell 
into this category. The analysis also presumed that an economic impact 
greater than one percent of annualized incremental cost as a percentage 
of revenue was a more moderate impact. The analysis indicated that 
fewer than one percent of small entities fell into this category. The 
analysis also presumed that a substantial number of small entities are 
affected if more than twenty percent of small entities are impacted. 
The analysis indicated that about 1.0 percent of small entities would 
be affected by the requirement to submit an examination support 
document, that about 2.7 percent of small entities would be affected by 
the requirement to submit a petition for an additional continued 
examination filing, and that about 0.3 percent of small entities would 
be affected by both the requirement to submit an examination support 
document and the requirement to submit a petition for an additional 
continued examination filing. A copy of the report containing this 
analysis is available on the Office's Internet Web site at http://www.uspto.gov.
    As a result of this analysis, the Office has determined that it is 
appropriate to make a certification that the changes being adopted in 
this final rule would not have a significant economic impact on a 
substantial number of small entities. The Office has revised the final 
rule requirements, as discussed previously, to further reduce economic 
impacts on small entities.
    SBA-Advocacy commented that while the Office asserts that 
preparation of the examination support document should cost about 
$2,500, small entities contend that completing an examination support 
document will be more costly, time consuming and restrict their ability 
to prosecute patents vigorously. SBA-Advocacy also commented that small 
entity representatives have provided feedback that completion of an 
examination support document could cost from $25,000 to $30,000.
    The Claims Proposed Rule referenced a $2,500 figure covering a 
patent novelty search, analysis, and opinion, as reported in a 2003 
survey conducted by the American Intellectual Property Law Association 
(AIPLA). The Office agrees with the comments that this figure is 
probably less than the cost of an examination support document in most 
situations. Therefore, the Office has further analyzed costs based on 
the modified examination support document requirements applicable to 
small entities. The analysis models cost variability based on the 
number of claims the examination support document must address, and on 
whether or not a prior art search was conducted when the application 
was prepared. Based on this analysis, the Office estimates that the 
examination support document costs for small entities will range from 
$2,563 up to $13,121, although this latter figure assumes the 
examination support document must address as many as fifty independent 
claims or three hundred and fifty total claims. Only a small number of 
small entities, however, will be required to prepare an examination 
support document, and nearly all of these will incur costs towards the 
lower end of the range. Thus, the Office does not expect the final rule 
to result in a

[[Page 46832]]

significant impact on a substantial number of small entities.
    SBA-Advocacy commented that small entity representatives have 
asserted that, taken together, the two proposed changes would increase 
the cost of application preparation and hinder the patent prosecution 
process.
    As discussed previously, the Office commissioned a detailed 
analysis of the impact of the final rule on small entities. The 
analysis explicitly considered the combined cost of both proposed rules 
(which have been combined into a single final rule). The analysis 
concludes that the final rule is not expected to result in a 
significant economic impact on a substantial number of small entities.
    SBA-Advocacy commented that small entity representatives have 
raised concerns that the proposed changes will significantly impact the 
most valuable and commercially viable patents because those types of 
patents typically involved a higher number of continuations.
    The Office notes that there are studies espousing the position that 
many commercially valuable patents are the result of a continuing 
application, or of a second or subsequent continuing application. 
However, these studies do not support the position that the applicants 
could not have obtained these commercially valuable patents but for the 
availability of an unlimited number of continuing applications. That 
is, these studies do not show that these commercially valuable patents 
could not have been obtained via two or fewer continuing applications 
prosecuted with a reasonable amount of foresight and diligence. Thus, 
these studies do not demonstrate that these commercially valuable 
patents happen to be the result of a continuing application or of 
multiple continuing applications for any reason other than simply 
because the prosecution tactics employed in the applications underlying 
these patents were based upon the availability of an unlimited number 
of continuing applications.
    The analysis commissioned by the Office specifically considered the 
claim that the most valuable and commercially viable patents are those 
types of patents that typically involved a higher number of 
continuations. The Office ultimately rejected the claim that this final 
rule will preclude applicants from being able to obtain a patent on the 
most valuable and commercially viable patents due to the speculative 
nature of the nexus drawn between the availability of an unlimited 
number of continuing applications and an applicant's ability to obtain 
these commercially valuable patents.
    SBA-Advocacy commented that small entity representatives have 
indicated that limiting applicants to ten representative claims would 
make it very difficult to properly identify a potential patent, could 
create future liability concerns, and would weaken potential patents.
    The final rule requirements apply to patent applications with more 
than five independent claims or more than twenty-five total claims, 
rather than ten representative claims. As discussed previously, 
applicants with more than five but less than fifteen independent 
claims, or more than twenty-five but less than seventy-five total 
claims, to an invention are able to prosecute their application in a 
manner that does not trigger the claims or continuations requirements. 
Specifically, an applicant may do this by submitting an initial 
application containing up to five independent claims and up to twenty-
five total claims, and then adding a similar number of claims in each 
of two continuation applications (or two continuation-in-part 
applications, or one continuation application and one continuation-in-
part application) permitted without a petition. Moreover, even for 
those applications that will require an examination support document, 
the requirement does not ``limit'' applicants to any particular number 
of claims. Applicants may continue to submit as many claims as 
necessary to appropriately claim their inventions, even if doing so 
required them to prepare and submit an examination support document.
    SBA-Advocacy commented that small entity representatives have 
contended that limiting continuation applications and examinations 
would inhibit their ability to enhance their applications, 
significantly increase costs through new fees, and force small entities 
to seek review through the very expensive appeals process. Small entity 
representatives thus assert that limiting the number of continuations 
could severely weaken small entities' ability to protect their patents.
    The Office analysis indicates that the continued examination filing 
requirements adopted in this final rule will not lead to significant 
cost increases nor will it have a significant economic impact on a 
substantial number of small entities. The requirements are necessary to 
ensure that patent applications are of reasonable quality and that 
applicants pursue their patents in good faith. The excessive use of 
continued examination filings has been a major factor in the growing 
backlog of unexamined applications. With respect to having to use the 
appeals process in place of additional continued examination filings, 
if an applicant disagrees with the examiner's rejections, the applicant 
should file an appeal rather than filing a continuation application or 
a request for continued examination, for reasons discussed in detail in 
the statement of considerations for the final rule. The Office believes 
that applicants should have sufficient opportunity to place the 
application in condition for appeal during the prosecution of the 
initial application, two continuing applications, and a request for 
continued examination. An applicant who considers this to be 
insufficient may file a third or subsequent continuing application or 
second or subsequent request for continued examination with a petition 
showing why the amendment, argument, or evidence sought to be entered 
could not have been previously submitted.
    SBA-Advocacy commented that the proposed changes will affect a 
substantial number of small entities, and that the two proposed changes 
to the rules reshape the basic rights of any small entity that files a 
patent application.
    The Office agrees that the final rule places new requirements on 
the current patent application process. However, the Office's analysis 
indicates that the rule will not have a significant economic impact on 
a substantial number of small entities. In fact, only a small 
proportion of small entities will be affected by the changes in this 
final rule.
    SBA-Advocacy commented that small entity representatives have 
contended that the definition of small entity that the Office uses in 
its certification is for calculating filing fees and excludes any small 
entity that has a contractual arrangement involving the invention with 
a larger company. SBA-Advocacy commented that small entity 
representatives have further asserted that small business size 
standards for Regulatory Flexibility Act purposes do not include this 
restriction so the number of small businesses affected is likely to be 
larger than stated in the certification.
    The Regulatory Flexibility Act permits an agency head to establish, 
for purposes of Regulatory Flexibility Act analysis and certification, 
one or more definitions of ``small business concern'' that are 
appropriate to the activities of the agency, after consultation with 
the Office of Advocacy of the Small Business Administration and after 
opportunity for public comment. See 5

[[Page 46833]]

U.S.C. 601(3) and 13 CFR 121.903(c). Pursuant to this authority, the 
Office has established the following definition of small business 
concern for purposes of the Office conducting an analysis or making a 
certification under the Regulatory Flexibility Act for patent-related 
regulations: A small business concern for Regulatory Flexibility Act 
purposes for patent-related regulations is a business or other concern 
that: (1) Meets the Small Business Administration's definition of a 
``business concern or concern'' set forth in 13 CFR 121.105; and (2) 
meets the size standards set forth in 13 CFR 121.802 for the purpose of 
paying reduced patent fees, namely, an entity: (a) Whose number of 
employees, including affiliates, does not exceed 500 persons; and (b) 
which has not assigned, granted, conveyed, or licensed (and is under no 
obligation to do so) any rights in the invention to any person who made 
it and could not be classified as an independent inventor, or to any 
concern which would not qualify as a non-profit organization or a small 
business concern under this definition. See Business Size Standard for 
Purposes of United States Patent and Trademark Office Regulatory 
Flexibility Analysis for Patent-Related Regulations, 71 FR 67109, 67112 
(Nov. 20, 2006), 1313 Off. Gaz. Pat. Office 60, 63 (Dec. 12, 2006) 
(notice). Prior to establishing this definition of small business 
concern for purposes of the Office conducting an analysis or making a 
certification under the Regulatory Flexibility Act for patent-related 
regulations, the Office consulted with the Small Business 
Administration Office of Advocacy and published such a definition for 
public comment. See Size Standard for Purposes of United States Patent 
and Trademark Office Regulatory Flexibility Analysis for Patent-Related 
Regulations, 71 FR 38388 (Jul. 6, 2006), 1309 Off. Gaz. Pat. Office 37 
(Aug. 1, 2006) (notice). The Small Business Administration small entity 
size standards set forth in 13 CFR 121.802 excludes any business 
concern that has assigned, granted, conveyed, or licensed any rights in 
the invention to an entity which would not qualify for small entity 
status.
    Nevertheless, in analyzing the provisions of the final rule, the 
Office explicitly considered a sensitivity analysis that assumed all 
patent applicants qualified as small entities. Even under this 
sensitivity analysis, this final rule is not expected to result in a 
significant impact on a substantial number of small entities.
    SBA-Advocacy suggested that with respect to the continued 
examination filing requirements, the Office should increase the number 
of permissible continuing applications.
    The final rule changes the continued examination filing petition 
threshold from a single continuation application, continuation-in-part 
application, or request for continued examination as proposed to two 
continuing applications (continuation or continuation-in-part 
applications), and a single request for continued examination in any 
one of the initial or two continuing applications.
    SBA-Advocacy suggested that with respect to the continued 
examination filing requirement, the Office should consider increasing 
the fees for additional continuation applications.
    Currently, patent application and excess claims fees are set by 
statute (35 U.S.C. 41(a)). In 2002, the Office proposed a patent fee 
structure that included a graduated excess claims fees schedule and 
additional fees for continued examination filings. As discussed 
previously, however, the Office was unable to garner sufficient support 
from patent user groups for a patent fee structure including a 
graduated excess claims fees schedule or any additional fees for 
continued examination filings. Therefore, the Office did not pursue 
this alternative.
    SBA-Advocacy suggested that with respect to the continued 
examination filing requirement, the Office should defer review of 
subsequent continuation applications.
    The Office considered expanding the deferral of examination 
provisions to allow a longer deferral of examination period. The Office 
currently has a provision (37 CFR 1.103(d)) under which an applicant 
may request deferral of examination for up to three years from the 
earliest filing date for which a benefit is claimed. As discussed 
previously, the Office is studying whether changes (e.g., the maximum 
deferral period, third party request for examination, and patent term 
adjustment) to the deferral of examination procedure would be 
appropriate.
    SBA-Advocacy suggested that with respect to the claims 
requirements, the Office should expand the number of representative 
claims included in initial review.
    The Office has revised the final rule to change the examination 
support document threshold from ten representative claims to five 
independent claims or twenty-five total claims. As discussed 
previously, however, applicants with more than five but less than 
fifteen independent claims, or more than twenty-five but less than 
seventy-five total claims, to an invention are able to prosecute their 
application in a manner that does not trigger the claims or 
continuations requirements.
    SBA-Advocacy suggested that with respect to the claims 
requirements, the Office should provide expedited review of 
applications that contain ten or fewer representative claims. The 
Office has considered the suggestion to provide expedited examination 
to applications containing less than a set number of claims. As 
discussed previously, the Office currently has an accelerated 
examination program for applicants who limit the number of claims in 
their applications (to no more than three independent claims and no 
more than twenty total claims) and who also provide an accelerated 
examination support document. Therefore, the Office did not pursue this 
alternative in the final rule.
    SBA-Advocacy suggested that with respect to the claims 
requirements, the Office should not apply the regulation to the backlog 
of pending unexamined applications.
    The Office has considered not applying the claims requirement to 
pending applications that have not yet been examined to minimize the 
impact on small entities. The examination support document threshold 
being adopted in this final rule (i.e., more than five independent 
claims or more than twenty-five total claims) means that most small 
entity applications will not be impacted by the final rule or the 
decision to apply the final rule to the backlog of unexamined 
applications. Given the current backlog of over 700,000 unexamined 
applications, a decision to not apply the changes to the backlog of 
unexamined applications would mean that it would be calendar year 2010 
before the Office would see any benefit from the change, and that the 
Office (and applicants) would be in a transition state until late 
calendar year 2011. Therefore, this suggestion was not adopted in the 
final rule.
    The Office also received a number of additional comments from the 
public generally asserting that the Office did not comply with the 
requirements of the Regulatory Flexibility Act in certifying that the 
changes in this rule making will not have a significant economic impact 
on a substantial number of small entities. The comments stated that: 
(1) In light of the fact that several large companies support the 
proposed changes it is questionable whether the rule changes are truly 
neutral towards small companies and that a bias in favor of large 
companies and against small entities could be in violation of the 
Regulatory Flexibility Act; (2) the Office's certification did not 
adequately

[[Page 46834]]

address the impact of the proposed rules on small entities, and the 
Office failed to provide a credible factual basis to justify its 
certification that the proposed rules would not have a significant 
economic impact on a substantial number of small entities in compliance 
with 5 U.S.C. 605(b); (3) the rule changes would have a significant 
economic impact on a substantial number of small entities seeking 
patents due to the additional costs associated with preparing an 
application, establishing the required showing under 37 CFR 
1.78(d)(1)(vi) and 1.114(g), and supplying an examination support 
document in compliance with 37 CFR 1.265, and would hinder the 
abilities of small entities to enhance their applications and protect 
their inventions; (4) the definition of small entities used by the 
Office in its certification of the proposed rules is for the purpose of 
paying reduced patent fees and excludes any application from a small 
business that has assigned, granted, conveyed, or licensed any rights 
in the invention to an entity which would not qualify for small entity 
status; (5) the Office should prepare an initial Regulatory Flexibility 
Analysis and republish the proposed rules before issuing any final rule 
to enable the Office to closely examine the impact on the affected 
small entities, encourage small entities to comment on additional 
information provided by the analysis, identify viable regulatory 
alternatives to the proposed rules, and demonstrate the Office's 
compliance with the Regulatory Flexibility Act; (6) the Office did not 
describe any viable alternatives to the proposed rules to provide 
regulatory relief to small entities as required under 5 U.S.C. 603(c); 
(7) the rule changes would be invalid and vulnerable to challenges 
under 5 U.S.C. 611 if the Office fails to comply with the requirements 
of the Regulatory Flexibility Act; and (8) the Office should exempt 
small entities from complying with the proposed rules to avoid further 
scrutiny under the Regulatory Flexibility Act.
    The Office has received comments from some large entities that the 
changes being adopted in this final rule have a bias against large 
entities, and has received comments from small entities that the 
changes being adopted in this final rule have a bias in favor of large 
entities. The changes being adopted in this final rule are neutral 
towards both small entities and large entities. That several large 
entities support the changes being adopted in this final rule is more 
likely indicative of a willingness to take a systemic view with respect 
to the need to take more significant steps to address patent quality 
and pendency.
    As discussed previously, the Office commissioned a detailed 
analysis of the final rule's impact on small entities. As a result of 
this analysis, the Office has determined that it is appropriate to make 
a certification that the changes being adopted in this final rule would 
not have a significant economic impact on a substantial number of small 
entities. Therefore, the Office is not required to conduct a Regulatory 
Flexibility Analysis.
    Pursuant to 5 U.S.C. 605(b), the requirements in 5 U.S.C. 603 and 
604 for an initial and final Regulatory Flexibility Analysis (including 
identification of viable regulatory alternatives to the proposed rules) 
do not apply if the agency head certifies that the changes will not 
have a significant economic impact on a substantial number of small 
entities. In accordance with 5 U.S.C. 605(b), the Deputy General 
Counsel for General Law of the United States Patent and Trademark 
Office has certified to the Chief Counsel for Advocacy of the Small 
Business Administration that the proposed changes would not have a 
significant economic impact on a substantial number of small entities.
    The Office considers this rule making to be in compliance with the 
requirements of the Regulatory Flexibility Act. Thus, the possibility 
of legal action does not warrant a decision to delay proceeding with 
the changes being adopted in this final rule to allow for preparation 
of an initial and final Regulatory Flexibility Analysis, or to 
completely exempt small entities from complying with the changes being 
adopted in this final rule.

C. Executive Order 13132 (Federalism)

    This rule making does not contain policies with federalism 
implications sufficient to warrant preparation of a Federalism 
Assessment under Executive Order 13132 (Aug. 4, 1999).

D. Executive Order 12866 (Regulatory Planning and Review)

    This rule making has been determined to be significant for purposes 
of Executive Order 12866 (Sept. 30, 1993), as amended by Executive 
Order 13258 (Feb. 26, 2002) and Executive Order 13422 (Jan. 18, 2007).

E. Executive Order 13175 (Tribal Consultation)

    This rule making will not: (1) Have substantial direct effects on 
one or more Indian tribes; (2) impose substantial direct compliance 
costs on Indian tribal governments; or (3) preempt tribal law. 
Therefore, a tribal summary impact statement is not required under 
Executive Order 13175 (Nov. 6, 2000).

F. Executive Order 13211 (Energy Effects)

    This rule making is not a significant energy action under Executive 
Order 13211 because this rule making is not likely to have a 
significant adverse effect on the supply, distribution, or use of 
energy. Therefore, a Statement of Energy Effects is not required under 
Executive Order 13211 (May 18, 2001).

G. Executive Order 12988 (Civil Justice Reform)

    This rule making meets applicable standards to minimize litigation, 
eliminate ambiguity, and reduce burden as set forth in sections 3(a) 
and 3(b)(2) of Executive Order 12988 (Feb. 5, 1996).

H. Executive Order 13045 (Protection of Children)

    This rule making is not an economically significant rule and does 
not concern an environmental risk to health or safety that may 
disproportionately affect children under Executive Order 13045 (Apr, 
21, 1997).

I. Executive Order 12630 (Taking of Private Property)

    This rule making will not effect a taking of private property or 
otherwise have taking implications under Executive Order 12630 (Mar. 
15, 1988).

J. Congressional Review Act

    Under the Congressional Review Act provisions of the Small Business 
Regulatory Enforcement Fairness Act of 1996 (5 U.S.C. 801 et seq.), the 
United States Patent and Trademark Office will submit a report 
containing this final rule and other required information to the U.S. 
Senate, the U.S. House of Representatives and the Comptroller General 
of the Government Accountability Office. The changes in this final rule 
will not result in an annual effect on the economy of 100 million 
dollars or more, a major increase in costs or prices, or significant 
adverse effects on competition, employment, investment, productivity, 
innovation, or the ability of United States-based enterprises to 
compete with foreign-based enterprises in domestic and export markets. 
Therefore, this final rule is not a ``major rule'' as defined in 5 
U.S.C. 804(2).

K. Unfunded Mandates Reform Act of 1995

    The changes in this final rule will not result in the expenditure 
by State, local,

[[Page 46835]]

and tribal governments, in the aggregate, or by the private sector, of 
100 million dollars or more in any one year, and it will not 
significantly or uniquely affect small governments. Therefore, no 
actions are necessary under the provisions of the Unfunded Mandates 
Reform Act of 1995. See 2 U.S.C. 1501 et seq.

L. National Environmental Policy Act

    This rule making will not have any effect on the quality of 
environment and is thus categorically excluded from review under the 
National Environmental Policy Act of 1969. See 42 U.S.C. 4321 et seq.

M. National Technology Transfer and Advancement Act

    The requirements of section 12(d) of the National Technology 
Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) are 
inapplicable because this rule making does not contain provisions which 
involve the use of technical standards.

N. Paperwork Reduction Act

    This final rule involves information collection requirements which 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). The 
collection of information involved in this final rule has been reviewed 
and approved by OMB under OMB control number 0651-0031. This final rule 
provides that: (1) A third or subsequent continuation or continuation-
in-part application or any second or subsequent request for continued 
examination must include a showing that the amendment, argument, or 
evidence sought to be entered could not have been submitted prior to 
the close of prosecution after a first and second continuation or 
continuation-in-part application and a request for continued 
examination; (2) an application that contains or is amended to contain 
more than five independent claims or more than twenty-five total claims 
must include an examination support document under 37 CFR 1.265 that 
covers each claim (whether in independent or dependent form) before the 
issuance of a first Office action on the merits; and (3) multiple 
applications that have the same claimed filing or priority date, 
substantial overlapping disclosure, a common inventor, and a common 
assignee must include either an explanation of how the claims are 
patentably distinct, or a terminal disclaimer and explanation of why 
patentably indistinct claims have been filed in multiple applications. 
The United States Patent and Trademark Office has resubmitted an 
information collection package to OMB for its review and approval 
because the changes in this notice do affect the information collection 
requirements associated with the information collection under OMB 
control number 0651-0031.
    The title, description and respondent description of the 
information collection under OMB control number 0651-0031 is shown 
below with an estimate of the annual reporting burdens. Included in the 
estimate is the time for reviewing instructions, gathering and 
maintaining the data needed, and completing and reviewing the 
collection of information.
    OMB Number: 0651-0031.
    Title: Patent Processing (Updating).
    Form Numbers: PTO/SB/08, PTO/SB/17i, PTO/SB/17p, PTO/SB/21-27, PTO/
SB/24B, PTO/SB/30-32, PTO/SB/35-39, PTO/SB/42-43, PTO/SB/61-64, PTO/SB/
64a, PTO/SB/67-68, PTO/SB/91-92, PTO/SB/96-97, PTO-2053-A/B, PTO-2054-
A/B, PTO-2055-A/B, PTOL-413A.
    Type of Review: Approved through September of 2007.
    Affected Public: Individuals or households, business or other for-
profit institutions, not-for-profit institutions, farms, Federal 
Government and State, Local and Tribal Governments.
    Estimated Number of Respondents: 2,508,139.
    Estimated Time Per Response: 1 minute and 48 seconds to 24 hours.
    Estimated Total Annual Burden Hours: 3,724,791 hours.
    Needs and Uses: During the processing of an application for a 
patent, the applicant or applicant's representative may be required or 
desire to submit additional information to the United States Patent and 
Trademark Office concerning the examination of a specific application. 
The specific information required or which may be submitted includes: 
information disclosure statement and citation, examination support 
documents, requests for extensions of time, the establishment of small 
entity status, abandonment and revival of abandoned applications, 
disclaimers, appeals, petitions, expedited examination of design 
applications, transmittal forms, requests to inspect, copy and access 
patent applications, publication requests, and certificates of mailing, 
transmittals, and submission of priority documents and amendments.
    Comments are invited on: (1) Whether the collection of information 
is necessary for proper performance of the functions of the agency; (2) 
the accuracy of the agency's estimate of the burden; (3) ways to 
enhance the quality, utility, and clarity of the information to be 
collected; and (4) ways to minimize the burden of the collection of 
information to respondents.
    Interested persons are requested to send comments regarding these 
information collections, including suggestions for reducing this 
burden, to: (1) The Office of Information and Regulatory Affairs, 
Office of Management and Budget, New Executive Office Building, Room 
10202, 725 17th Street, NW., Washington, DC 20503, Attention: Desk 
Officer for the Patent and Trademark Office; and (2) Robert A. Clarke, 
Director, Office of Patent Legal Administration, Commissioner for 
Patents, P.O. Box 1450, Alexandria, VA 22313-1450.
    Notwithstanding any other provision of law, no person is required 
to respond to nor shall a person be subject to a penalty for failure to 
comply with a collection of information subject to the requirements of 
the Paperwork Reduction Act unless that collection of information 
displays a currently valid OMB control number.

List of Subjects in 37 CFR Part 1

    Administrative practice and procedure, Courts, Freedom of 
Information, Inventions and patents, Reporting and recordkeeping 
requirements, Small Businesses.

0
For the reasons set forth in the preamble, 37 CFR part 1 is amended as 
follows:

PART 1--RULES OF PRACTICE IN PATENT CASES

0
1. The authority citation for 37 CFR part 1 continues to read as 
follows:

    Authority: 35 U.S.C. 2(b)(2).
0
2. Section 1.17 is amended by revising paragraph (f) to read as 
follows:


Sec.  1.17  Patent application and reexamination processing fees.

* * * * *
    (f) For filing a petition under one of the following sections which 
refers to this paragraph: $400.00
    Sec.  1.36(a)--for revocation of a power of attorney by fewer than 
all of the applicants.
    Sec.  1.53(e)--to accord a filing date.
    Sec.  1.57(a)--to accord a filing date.
    Sec.  1.78(d)(1)(vi)--for a continuing application not provided for 
in Sec. Sec.  1.78(d)(1)(i) through (d)(1)(v).
    Sec.  1.114(g)--for a request for continued examination not 
provided for in Sec.  1.114(f).
    Sec.  1.182--for decision on a question not specifically provided 
for.
    Sec.  1.183--to suspend the rules.
    Sec.  1.378(e)--for reconsideration of decision on petition 
refusing to accept

[[Page 46836]]

delayed payment of maintenance fee in an expired patent.
    Sec.  1.741(b)--to accord a filing date to an application under 
Sec.  1.740 for extension of a patent term.
* * * * *

0
3. Section 1.26 is amended by revising paragraphs (a) and (b) to read 
as follows:


Sec.  1.26  Refunds.

    (a) The Director may refund any fee paid by mistake or in excess of 
that required. Except as provided in Sec.  1.117 or Sec.  1.138(d), a 
change of purpose after the payment of a fee, such as when a party 
desires to withdraw a patent filing for which the fee was paid, 
including an application, an appeal, or a request for an oral hearing, 
will not entitle a party to a refund of such fee. The Office will not 
refund amounts of twenty-five dollars or less unless a refund is 
specifically requested, and will not notify the payor of such amounts. 
If a party paying a fee or requesting a refund does not provide the 
banking information necessary for making refunds by electronic funds 
transfer (31 U.S.C. 3332 and 31 CFR part 208), or instruct the Office 
that refunds are to be credited to a deposit account, the Director may 
require such information, or use the banking information on the payment 
instrument to make a refund. Any refund of a fee paid by credit card 
will be by a credit to the credit card account to which the fee was 
charged.
    (b) Any request for refund must be filed within two years from the 
date the fee was paid, except as otherwise provided in this paragraph, 
or in Sec.  1.28(a), Sec.  1.117(b), or Sec.  1.138(d). If the Office 
charges a deposit account by an amount other than an amount 
specifically indicated in an authorization (Sec.  1.25(b)), any request 
for refund based upon such charge must be filed within two years from 
the date of the deposit account statement indicating such charge, and 
include a copy of that deposit account statement. The time periods set 
forth in this paragraph are not extendable.
* * * * *

0
4. Section 1.52 is amended by revising paragraph (d)(2) to read as 
follows:


Sec.  1.52  Language, paper, writing, margins, compact disc 
specifications.

* * * * *
    (d) * * *
    (2) Provisional application. If a provisional application is filed 
in a language other than English and the benefit of such provisional 
application is claimed in a nonprovisional application, an English 
language translation of the non-English language provisional 
application will be required in the provisional application. See Sec.  
1.78(b).
* * * * *

0
5. Section 1.53 is amended by revising paragraphs (b) and (c)(4) to 
read as follows:


Sec.  1.53  Application number, filing date, and completion of 
application.

* * * * *
    (b) Application filing requirements--Nonprovisional application. 
The filing date of an application for patent filed under this section, 
except for a provisional application under paragraph (c) of this 
section or a continued prosecution application under paragraph (d) of 
this section, is the date on which a specification as prescribed by 35 
U.S.C. 112 containing a description pursuant to Sec.  1.71 and at least 
one claim pursuant to Sec.  1.75, and any drawing required by Sec.  
1.81(a) are filed in the Patent and Trademark Office. No new matter may 
be introduced into an application after its filing date. A continuing 
application, which may be a continuation, divisional, or continuation-
in-part application, may be filed under this section if the conditions 
specified in 35 U.S.C. 120, 121, or 365(c) and Sec.  1.78 are met.
    (1) A continuation or divisional application that names as 
inventors the same or fewer than all of the inventors named in the 
prior application may be filed under paragraph (b) or (d) of this 
section. A continuation or divisional application naming an inventor 
not named in the prior application must be filed under paragraph (b) of 
this section. See Sec.  1.78(a)(2) for the definition of a divisional 
application and Sec.  1.78(a)(3) for the definition of a continuation 
application.
    (2) A continuation-in-part application must be filed under 
paragraph (b) of this section. See Sec.  1.78(a)(4) for the definition 
of a continuation-in-part application.
    (c) * * *
    (4) A provisional application is not entitled to the right of 
priority under 35 U.S.C. 119 or 365(a) or Sec.  1.55, or to the benefit 
of an earlier filing date under 35 U.S.C. 120, 121 or 365(c) or Sec.  
1.78 of any other application. No claim for priority under 35 U.S.C. 
119(e) or Sec.  1.78 may be made in a design application based on a 
provisional application. No request under Sec.  1.293 for a statutory 
invention registration may be filed in a provisional application. The 
requirements of Sec. Sec.  1.821 through 1.825 regarding application 
disclosures containing nucleotide and/or amino acid sequences are not 
mandatory for provisional applications.
* * * * *

0
6. Section 1.75 is amended by revising paragraphs (b) and (c) to read 
as follows:


Sec.  1.75  Claim(s).

* * * * *
    (b) More than one claim may be presented provided they differ 
substantially from each other and are not unduly multiplied. One or 
more claims may be presented in dependent form, referring back to and 
further limiting another claim or claims in the same application. A 
dependent claim must contain a reference to a claim previously set 
forth in the same application, incorporate by reference all the 
limitations of the previous claim to which such dependent claim refers, 
and specify a further limitation of the subject matter of the previous 
claim.
    (1) An applicant must file an examination support document in 
compliance with Sec.  1.265 that covers each claim (whether in 
independent or dependent form) before the issuance of a first Office 
action on the merits of the application if the application contains or 
is amended to contain more than five independent claims or more than 
twenty-five total claims. An application may not contain or be amended 
to contain more than five independent claims or more than twenty-five 
total claims if an examination support document in compliance with 
Sec.  1.265 has not been filed before the issuance of a first Office 
action on the merits of the application.
    (2) A claim that refers to another claim but does not incorporate 
by reference all of the limitations of the claim to which such claim 
refers will be treated as an independent claim for fee calculation 
purposes under Sec.  1.16 (or Sec.  1.492) and for purposes of 
paragraph (b) of this section. A claim that refers to a claim of a 
different statutory class of invention will also be treated as an 
independent claim for fee calculation purposes under Sec.  1.16 (or 
Sec.  1.492) and for purposes of paragraph (b) of this section.
    (3) The applicant will be notified if the application contains or 
is amended to contain more than five independent claims or more than 
twenty-five total claims but the applicant has not complied with the 
requirements set forth in paragraph (b)(1) or (b)(4) of this section. 
If the non-compliance appears to have been inadvertent, the notice will 
set a two-month time period that is not extendable under Sec.  1.136(a) 
within which, to avoid abandonment of the application, the applicant 
must comply

[[Page 46837]]

with the requirements set forth in paragraph (b) of this section.
    (4) If a nonprovisional application contains at least one claim 
that is patentably indistinct from at least one claim in one or more 
other pending nonprovisional applications, and if such one or more 
other nonprovisional applications and the first nonprovisional 
application are owned by the same person, or are subject to an 
obligation of assignment to the same person, the Office will treat the 
claims (whether in independent or dependent form) in the first 
nonprovisional application and in each of such other pending 
nonprovisional applications as present in each of the nonprovisional 
applications for purposes of paragraph (b) of this section.
    (5) Claims withdrawn from consideration under Sec. Sec.  1.141 
through 1.146 or Sec.  1.499 as drawn to a non-elected invention or 
inventions will not, unless they are reinstated or rejoined, be taken 
into account in determining whether an application exceeds the five 
independent claim and twenty-five total claim threshold set forth in 
paragraphs (b)(1), (b)(3), and (b)(4) of this section.
    (c) Any dependent claim which refers to more than one other claim 
(``multiple dependent claim'') shall refer to such other claims in the 
alternative only. A multiple dependent claim shall not serve as a basis 
for any other multiple dependent claim. For fee calculation purposes 
under Sec.  1.16 (or Sec.  1.492) and for purposes of paragraph (b) of 
this section, a multiple dependent claim will be considered to be that 
number of claims to which direct reference is made therein. For fee 
calculation purposes under Sec.  1.16 (or Sec.  1.492) and for purposes 
of paragraph (b) of this section, any claim depending from a multiple 
dependent claim will be considered to be that number of claims to which 
direct reference is made in that multiple dependent claim. In addition 
to the other filing fees, any application which is filed with, or is 
amended to include, multiple dependent claims must have paid therein 
the fee set forth in Sec.  1.16(j). A multiple dependent claim shall be 
construed to incorporate by reference all the limitations of each of 
the particular claims in relation to which it is being considered.
* * * * *
0
7. Section 1.76 is amended by revising paragraph (b)(5) to read as 
follows:


Sec.  1.76  Application data sheet.

* * * * *
    (b) * * *
    (5) Domestic priority information. This information includes the 
application number, the filing date, and relationship of each 
application for which a benefit is claimed under 35 U.S.C. 120, 121, or 
365(c). This information includes the application number and the filing 
date of each application for which a benefit is claimed under 35 U.S.C. 
119(e). Providing this information in the application data sheet also 
constitutes the specific reference required by 35 U.S.C. 119(e) or 120, 
and Sec.  1.78(b)(3) or Sec.  1.78(d)(3), and need not otherwise be 
made part of the specification.
* * * * *

0
8. Section 1.78 is revised to read as follows:


Sec.  1.78  Claiming benefit of earlier filing date and cross-
references to other applications.

    (a) Definitions--(1) Continuing application. A continuing 
application is a nonprovisional application or an international 
application designating the United States of America that claims the 
benefit under 35 U.S.C. 120, 121, or 365(c) of a prior-filed 
nonprovisional application or international application designating the 
United States of America. An application that does not claim the 
benefit under 35 U.S.C. 120, 121, or 365(c) of a prior-filed 
application is not a continuing application even if the application 
claims the benefit under 35 U.S.C. 119(e) of a provisional application, 
claims priority under 35 U.S.C. 119(a)-(d) or 365(b) to a foreign 
application, or claims priority under 35 U.S.C. 365(a) or (b) to an 
international application designating at least one country other than 
the United States of America.
    (2) Divisional application. A divisional application is a 
continuing application as defined in paragraph (a)(1) of this section 
that discloses and claims only an invention or inventions that were 
disclosed and claimed in a prior-filed application, but were subject to 
a requirement to comply with the requirement of unity of invention 
under PCT Rule 13 or a requirement for restriction under 35 U.S.C. 121 
in the prior-filed application, and were not elected for examination 
and were not examined in any prior-filed application.
    (3) Continuation application. A continuation application is a 
continuing application as defined in paragraph (a)(1) of this section 
that discloses and claims only an invention or inventions that were 
disclosed in the prior-filed application.
    (4) Continuation-in-part application. A continuation-in-part 
application is a continuing application as defined in paragraph (a)(1) 
of this section that discloses subject matter that was not disclosed in 
the prior-filed application.
    (b) Claims under 35 U.S.C. 119(e) for the benefit of a prior-filed 
provisional application. A nonprovisional application, other than for a 
design patent, or an international application designating the United 
States of America may claim the benefit of one or more prior-filed 
provisional applications under the conditions set forth in 35 U.S.C. 
119(e) and paragraph (b) of this section.
    (1) The nonprovisional application or international application 
designating the United States of America must be filed not later than 
twelve months after the date on which the provisional application was 
filed. This twelve-month period is subject to 35 U.S.C. 21(b) and Sec.  
1.7(a).
    (2) Each prior-filed provisional application must name as an 
inventor at least one inventor named in the later-filed application. In 
addition, each prior-filed provisional application must be entitled to 
a filing date as set forth in Sec.  1.53(c) and the basic filing fee 
set forth in Sec.  1.16(d) must have been paid for such provisional 
application within the time period set forth in Sec.  1.53(g).
    (3) Any nonprovisional application or international application 
designating the United States of America that claims the benefit of one 
or more prior-filed provisional applications must contain or be amended 
to contain a reference to each such prior-filed provisional 
application, identifying it by the provisional application number 
(consisting of series code and serial number). If the later-filed 
application is a nonprovisional application, the reference required by 
this paragraph must be included in an application data sheet (Sec.  
1.76), or the specification must contain or be amended to contain such 
reference in the first sentence(s) following the title.
    (4) The reference required by paragraph (b)(3) of this section must 
be submitted during the pendency of the later-filed application. If the 
later-filed application is an application filed under 35 U.S.C. 111(a), 
this reference must also be submitted within the later of four months 
from the actual filing date of the later-filed application or sixteen 
months from the filing date of the prior-filed provisional application. 
If the later-filed application is a nonprovisional application which 
entered the national stage from an international application after 
compliance with 35 U.S.C. 371, this reference must also be submitted 
within the later of four months from the date on which the national 
stage commenced under 35 U.S.C. 371(b) or (f) in the later-filed 
international application or sixteen months from the filing date of the 
prior-

[[Page 46838]]

filed provisional application. Except as provided in paragraph (c) of 
this section, failure to timely submit the reference is considered a 
waiver of any benefit under 35 U.S.C. 119(e) of the prior-filed 
provisional application. The time periods in this paragraph do not 
apply if the later-filed application is:
    (i) An application filed under 35 U.S.C. 111(a) before November 29, 
2000; or
    (ii) An international application filed under 35 U.S.C. 363 before 
November 29, 2000.
    (5) If the prior-filed provisional application was filed in a 
language other than English and both an English-language translation of 
the prior-filed provisional application and a statement that the 
translation is accurate were not previously filed in the prior-filed 
provisional application, applicant will be notified and given a period 
of time within which to file the translation and the statement in the 
prior-filed provisional application. If the notice is mailed in a 
pending nonprovisional application, a timely reply to such a notice 
must include the filing in the nonprovisional application of either a 
confirmation that the translation and statement were filed in the 
provisional application, or an amendment or supplemental application 
data sheet withdrawing the benefit claim, or the nonprovisional 
application will be abandoned. The translation and statement may be 
filed in the provisional application, even if the provisional 
application has become abandoned.
    (c) Delayed claims under 35 U.S.C. 119(e) for the benefit of a 
prior-filed provisional application. If the reference required by 35 
U.S.C. 119(e) and paragraph (b)(3) of this section is presented in a 
nonprovisional application after the time period provided by paragraph 
(b)(4) of this section, the claim under 35 U.S.C. 119(e) for the 
benefit of a prior-filed provisional application may be accepted if 
submitted during the pendency of the later-filed application and if the 
reference identifying the prior-filed application by provisional 
application number was unintentionally delayed. A petition to accept an 
unintentionally delayed claim under 35 U.S.C. 119(e) for the benefit of 
a prior-filed provisional application must be accompanied by:
    (1) The reference required by 35 U.S.C. 119(e) and paragraph (b)(3) 
of this section to the prior-filed provisional application, unless 
previously submitted;
    (2) The surcharge set forth in Sec.  1.17(t); and
    (3) A statement that the entire delay between the date the claim 
was due under paragraph (b)(4) of this section and the date the claim 
was filed was unintentional. The Director may require additional 
information where there is a question whether the delay was 
unintentional.
    (d) Claims under 35 U.S.C. 120, 121, or 365(c) for the benefit of a 
prior-filed nonprovisional or international application. A 
nonprovisional application (including an international application that 
has entered the national stage after compliance with 35 U.S.C. 371) may 
claim the benefit of one or more prior-filed copending nonprovisional 
applications or international applications designating the United 
States of America under the conditions set forth in 35 U.S.C. 120 and 
paragraph (d) of this section.
    (1) A nonprovisional application that claims the benefit of one or 
more prior-filed copending nonprovisional applications or international 
applications designating the United States of America must satisfy the 
conditions set forth in at least one of paragraphs (d)(1)(i) through 
(d)(1)(vi) of this section. The Office will refuse to enter, or will 
delete if present, any specific reference to a prior-filed application 
that is not permitted by at least one of paragraphs (d)(1)(i) through 
(d)(1)(vi) of this section. The Office's entry of, or failure to 
delete, a specific reference to a prior-filed application that is not 
permitted by at least one of paragraphs (d)(1)(i) through (d)(1)(vi) of 
this section does not constitute a waiver of the provisions of 
paragraph (d)(1) of this section.
    (i)(A) The nonprovisional application is either a continuation 
application as defined in paragraph (a)(3) of this section or a 
continuation-in-part application as defined in paragraph (a)(4) of this 
section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of 
no more than two prior-filed applications; and
    (B) Any application whose benefit is claimed under 35 U.S.C. 120, 
121, or 365(c) in such nonprovisional application has its benefit 
claimed in no more than one other nonprovisional application, not 
including any nonprovisional application that satisfies the conditions 
set forth in paragraph (d)(1)(ii), (d)(1)(iii) or (d)(1)(vi) of this 
section.
    (ii)(A) The nonprovisional application is a divisional application 
as defined in paragraph (a)(2) of this section that claims the benefit 
under 35 U.S.C. 120, 121, or 365(c) of a prior-filed application that 
was subject to a requirement to comply with the requirement of unity of 
invention under PCT Rule 13 or a requirement for restriction under 35 
U.S.C. 121; and
    (B) The divisional application contains only claims directed to an 
invention or inventions that were identified in such requirement to 
comply with the requirement of unity of invention or requirement for 
restriction but were not elected for examination and were not examined 
in the prior-filed application or in any other nonprovisional 
application, except for a nonprovisional application that claims the 
benefit under 35 U.S.C. 120, 121, or 365(c) of such divisional 
application and satisfies the conditions set forth in paragraph 
(d)(1)(iii) or (d)(1)(vi) of this section.
    (iii)(A) The nonprovisional application is a continuation 
application as defined in paragraph (a)(3) of this section that claims 
the benefit under 35 U.S.C. 120, 121, or 365(c) of a divisional 
application that satisfies the conditions set forth in paragraph 
(d)(1)(ii) of this section;
    (B) The nonprovisional application discloses and claims only an 
invention or inventions that were disclosed and claimed in such 
divisional application;
    (C) The nonprovisional application claims the benefit under 35 
U.S.C. 120, 121, or 365(c) of only the divisional application, any 
application to which such divisional application claims benefit under 
35 U.S.C. 120, 121, or 365(c) in compliance with the conditions set 
forth in paragraph (d)(1)(ii) of this section, and no more than one 
intervening prior-filed nonprovisional application; and
    (D) The divisional application whose benefit is claimed under 35 
U.S.C. 120, 121, or 365(c) in such nonprovisional application has its 
benefit claimed in no more than one other nonprovisional application, 
not including any other divisional application that satisfies the 
conditions set forth in paragraph (d)(1)(ii) or any nonprovisional 
application that claims the benefit under 35 U.S.C. 120 or 365(c) of 
such other divisional application and satisfies the conditions set 
forth in paragraph (d)(1)(iii) or (d)(1)(vi) of this section.
    (iv)(A) The nonprovisional application claims benefit under 35 
U.S.C. 120 or 365(c) of a prior-filed international application 
designating the United States of America, and a Demand has not been 
filed and the basic national fee (Sec.  1.492(a)) has not been paid in 
the prior-filed international application and the prior-filed 
international application does not claim the benefit of any other 
nonprovisional application or international application

[[Page 46839]]

designating the United States of America;
    (B) The nonprovisional application is either a continuation 
application as defined in paragraph (a)(3) of this section or a 
continuation-in-part application as defined in paragraph (a)(4) of this 
section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of 
no more than three prior-filed applications; and
    (C) Any application whose benefit is claimed under 35 U.S.C. 120, 
121, or 365(c) in such nonprovisional application has its benefit 
claimed in no more than two other nonprovisional applications, not 
including any nonprovisional application that satisfies the conditions 
set forth in paragraph (d)(1)(ii), (d)(1)(iii) or (d)(1)(vi) of this 
section.
    (v)(A) The nonprovisional application claims benefit under 35 
U.S.C. 120 or 365(c) of a prior-filed nonprovisional application filed 
under 35 U.S.C. 111(a), and such nonprovisional application became 
abandoned due to the failure to timely reply to an Office notice issued 
under Sec.  1.53(f) and does not claim the benefit of any other 
nonprovisional application or international application designating the 
United States of America;
    (B) The nonprovisional application is either a continuation 
application as defined in paragraph (a)(3) of this section or a 
continuation-in-part application as defined in paragraph (a)(4) of this 
section that claims the benefit under 35 U.S.C. 120, 121, or 365(c) of 
no more than three prior-filed applications; and
    (C) Any application whose benefit is claimed under 35 U.S.C. 120, 
121, or 365(c) in such nonprovisional application has its benefit 
claimed in no more than two other nonprovisional applications, not 
including any nonprovisional application that satisfies the conditions 
set forth in paragraph (d)(1)(ii), (d)(1)(iii) or (d)(1)(vi) of this 
section.
    (vi) The nonprovisional application is a continuing application as 
defined in paragraph (a)(1) of this section that claims the benefit 
under 35 U.S.C. 120, 121, or 365(c) of a prior-filed application, is 
filed to obtain consideration of an amendment, argument, or evidence 
that could not have been submitted during the prosecution of the prior-
filed application, and does not satisfy the conditions set forth in any 
of paragraphs (d)(1)(i) through (d)(1)(v) of this section. A petition 
must be filed in such nonprovisional application that is accompanied by 
the fee set forth in Sec.  1.17(f) and a showing that the amendment, 
argument, or evidence sought to be entered could not have been 
submitted during the prosecution of the prior-filed application. If the 
continuing application is an application filed under 35 U.S.C. 111(a), 
this petition must be submitted within four months from the actual 
filing date of the continuing application. If the continuing 
application is a nonprovisional application which entered the national 
stage from an international application after compliance with 35 U.S.C. 
371, this petition must be submitted within four months from the date 
on which the national stage commenced under 35 U.S.C. 371(b) or (f) in 
the international application.
    (2) Each prior-filed application must name as an inventor at least 
one inventor named in the later-filed application. In addition, each 
prior-filed application must either be:
    (i) An international application entitled to a filing date in 
accordance with PCT Article 11 and designating the United States of 
America; or
    (ii) A nonprovisional application under 35 U.S.C. 111(a) that is 
entitled to a filing date as set forth in Sec.  1.53(b) or Sec.  
1.53(d) for which the basic filing fee set forth in Sec.  1.16 has been 
paid within the pendency of the application.
    (3) Except for a continued prosecution application filed under 
Sec.  1.53(d), any nonprovisional application, or international 
application designating the United States of America, that claims the 
benefit of one or more prior-filed nonprovisional applications or 
international applications designating the United States of America 
must contain or be amended to contain a reference to each such prior-
filed application, identifying it by application number (consisting of 
the series code and serial number) or international application number 
and international filing date. The reference must also identify the 
relationship of the applications (i.e., whether the later-filed 
application is a continuation, divisional, or continuation-in-part of 
the prior-filed nonprovisional application or international 
application). If an application is identified as a continuation-in-part 
application, the applicant must identify the claim or claims in the 
continuation-in-part application for which the subject matter is 
disclosed in the manner provided by the first paragraph of 35 U.S.C. 
112 in the prior-filed application. If the later-filed application is a 
nonprovisional application, the reference required by this paragraph 
must be included in an application data sheet (Sec.  1.76), or the 
specification must contain or be amended to contain such reference in 
the first sentence(s) following the title.
    (4) The reference required by 35 U.S.C. 120 and paragraph (d)(3) of 
this section must be submitted during the pendency of the later-filed 
application. If the later-filed application is an application filed 
under 35 U.S.C. 111(a), this reference must also be submitted within 
the later of four months from the actual filing date of the later-filed 
application or sixteen months from the filing date of the prior-filed 
application. If the later-filed application is a nonprovisional 
application which entered the national stage from an international 
application after compliance with 35 U.S.C. 371, this reference must 
also be submitted within the later of four months from the date on 
which the national stage commenced under 35 U.S.C. 371(b) or (f) in the 
later-filed international application or sixteen months from the filing 
date of the prior-filed application. Except as provided in paragraph 
(e) of this section, failure to timely submit the reference required by 
35 U.S.C. 120 and paragraph (d)(3) of this section is considered a 
waiver of any benefit under 35 U.S.C. 120, 121, or 365(c) to the prior-
filed application. The time periods in this paragraph do not apply if 
the later-filed application is:
    (i) An application for a design patent;
    (ii) An application filed under 35 U.S.C. 111(a) before November 
29, 2000; or
    (iii) An international application filed under 35 U.S.C. 363 before 
November 29, 2000.
    (5) The request for a continued prosecution application under Sec.  
1.53(d) is the specific reference required by 35 U.S.C. 120 to the 
prior-filed application. The identification of an application by 
application number under this section is the identification of every 
application assigned that application number necessary for a specific 
reference required by 35 U.S.C. 120 to every such application assigned 
that application number.
    (6) Cross-references to other related applications may be made when 
appropriate. Cross-references to applications for which a benefit is 
not claimed under title 35, United States Code, must be located in a 
paragraph that is separate from the paragraph containing the references 
to applications for which a benefit is claimed under 35 U.S.C. 119(e), 
120, 121, or 365(c) that is required by 35 U.S.C. 119(e) or 120 and 
this section.
    (e) Delayed claims under 35 U.S.C. 120, 121, or 365(c) for the 
benefit of a prior-filed nonprovisional application or international 
application. If the reference required by 35 U.S.C. 120 and

[[Page 46840]]

paragraph (d)(3) of this section is presented after the time period 
provided by paragraph (d)(4) of this section, the claim under 35 U.S.C. 
120, 121, or 365(c) for the benefit of a prior-filed copending 
nonprovisional application or international application designating the 
United States of America may be accepted if the reference identifying 
the prior-filed application by application number or international 
application number and international filing date was unintentionally 
delayed. A petition to accept an unintentionally delayed claim under 35 
U.S.C. 120, 121, or 365(c) for the benefit of a prior-filed application 
must be accompanied by:
    (1) The reference required by 35 U.S.C. 120 and paragraph (d)(3) of 
this section to the prior-filed application, unless previously 
submitted;
    (2) The surcharge set forth in Sec.  1.17(t); and
    (3) A statement that the entire delay between the date the claim 
was due under paragraph (d)(4) of this section and the date the claim 
was filed was unintentional. The Director may require additional 
information where there is a question whether the delay was 
unintentional.
    (f) Applications and patents naming at least one inventor in 
common. (1)(i) The applicant in a nonprovisional application that has 
not been allowed (Sec.  1.311) must identify by application number 
(i.e., series code and serial number) and patent number (if applicable) 
each other pending or patented nonprovisional application, in a 
separate paper, for which the following conditions are met:
    (A) The nonprovisional application has a filing date that is the 
same as or within two months of the filing date of the other pending or 
patented nonprovisional application, taking into account any filing 
date for which a benefit is sought under title 35, United States Code;
    (B) The nonprovisional application names at least one inventor in 
common with the other pending or patented nonprovisional application; 
and
    (C) The nonprovisional application is owned by the same person, or 
subject to an obligation of assignment to the same person, as the other 
pending or patented nonprovisional application.
    (ii) The identification of such one or more other pending or 
patented nonprovisional applications if required by paragraph (f)(1)(i) 
of this section must be submitted within the later of:
    (A) Four months from the actual filing date in a nonprovisional 
application filed under 35 U.S.C. 111(a);
    (B) Four months from the date on which the national stage commenced 
under 35 U.S.C. 371(b) or (f) in a nonprovisional application entering 
the national stage from an international application under 35 U.S.C. 
371; or
    (C) Two months from the mailing date of the initial filing receipt 
in such other nonprovisional application for which identification is 
required by paragraph (f)(1)(i) of this section.
    (2)(i) A rebuttable presumption shall exist that a nonprovisional 
application contains at least one claim that is not patentably distinct 
from at least one of the claims in another pending or patented 
nonprovisional application if the following conditions are met:
    (A) The nonprovisional application has a filing date that is the 
same as the filing date of the other pending or patented nonprovisional 
application, taking into account any filing date for which a benefit is 
sought under title 35, United States Code;
    (B) The nonprovisional application names at least one inventor in 
common with the other pending or patented nonprovisional application;
    (C) The nonprovisional application is owned by the same person, or 
subject to an obligation of assignment to the same person, as the other 
pending or patented nonprovisional application; and
    (D) The nonprovisional application and the other pending or 
patented nonprovisional application contain substantial overlapping 
disclosure. Substantial overlapping disclosure exists if the other 
pending or patented nonprovisional application has written description 
support under the first paragraph of 35 U.S.C. 112 for at least one 
claim in the nonprovisional application.
    (ii) If the conditions specified in paragraph (f)(2)(i) of this 
section exist, the applicant in the nonprovisional application must, 
unless the nonprovisional application has been allowed (Sec.  1.311), 
take one of the following actions within the time period specified in 
paragraph (f)(2)(iii) of this section:
    (A) Rebut this presumption by explaining how the application 
contains only claims that are patentably distinct from the claims in 
each of such other pending nonprovisional applications or patents; or
    (B) Submit a terminal disclaimer in accordance with Sec.  1.321(c). 
In addition, where one or more other pending nonprovisional 
applications have been identified, the applicant must explain why there 
are two or more pending nonprovisional applications naming at least one 
inventor in common and owned by the same person, or subject to an 
obligation of assignment to the same person, which contain patentably 
indistinct claims.
    (iii) If the conditions specified in paragraph (f)(2)(i) of this 
section exist, the applicant in the nonprovisional application must, 
unless the nonprovisional application has been allowed (Sec.  1.311), 
take one of the actions specified in paragraph (f)(2)(ii) of this 
section within the later of:
    (A) Four months from the actual filing date of a nonprovisional 
application filed under 35 U.S.C. 111(a);
    (B) Four months from the date on which the national stage commenced 
under 35 U.S.C. 371(b) or (f) in a nonprovisional application entering 
the national stage from an international application under 35 U.S.C. 
371;
    (C) The date on which a claim that is not patentably distinct from 
at least one of the claims in the one or more other pending or patented 
nonprovisional applications is presented; or
    (D) Two months from the mailing date of the initial filing receipt 
in the one or more other pending or patented nonprovisional 
applications.
    (3) In the absence of good and sufficient reason for there being 
two or more pending nonprovisional applications owned by the same 
person, or subject to an obligation of assignment to the same person, 
which contain patentably indistinct claims, the Office may require 
elimination of the patentably indistinct claims from all but one of the 
applications.
    (g) Applications or patents under reexamination naming different 
inventors and containing patentably indistinct claims. If an 
application or a patent under reexamination and at least one other 
application naming different inventors are owned by the same party and 
contain patentably indistinct claims, and there is no statement of 
record indicating that the claimed inventions were commonly owned or 
subject to an obligation of assignment to the same person at the time 
the later invention was made, the Office may require the assignee to 
state whether the claimed inventions were commonly owned or subject to 
an obligation of assignment to the same person at the time the later 
invention was made, and if not, indicate which named inventor is the 
prior inventor.
    (h) Parties to a joint research agreement. If an application 
discloses or is amended to disclose the names of parties to a joint 
research agreement under 35 U.S.C. 103(c)(2)(C), the parties to the 
joint research agreement are considered to be the same person for 
purposes of this section. If the application is amended to disclose the 
names of parties to a joint research

[[Page 46841]]

agreement, the identification of such one or more other nonprovisional 
applications as required by paragraph (f)(1) of this section must be 
submitted with such amendment unless such identification is or has been 
submitted within the four-month period specified in paragraph (f)(1) of 
this section.
    (i) Time periods not extendable: The time periods set forth in this 
section are not extendable.

0
9. Section 1.104 is amended by revising paragraphs (a)(1) and (b) to 
read as follows:


Sec.  1.104  Nature of examination.

    (a) Examiner's action. (1) On taking up an application for 
examination or a patent in a reexamination proceeding, the examiner 
shall make a thorough study thereof and shall make a thorough 
investigation of the available prior art relating to the subject matter 
of the claimed invention. The examination shall be complete with 
respect both to compliance of the application or patent under 
reexamination with the applicable statutes, rules, and other 
requirements, and to the patentability of the invention as claimed, as 
well as with respect to matters of form, unless otherwise indicated.
* * * * *
    (b) Completeness of examiner's action. The examiner's action will 
be complete as to all matters, except that in appropriate 
circumstances, such as misjoinder of invention, fundamental defects in 
the application, and the like, the action of the examiner may be 
limited to such matters before further action is made.
* * * * *

0
10. Section 1.105 is amended by adding a new paragraph (a)(1)(ix) to 
read as follows:


Sec.  1.105  Requirements for information.

    (a)(1) * * *
    (ix) Support in the specification: Where (by page and line or 
paragraph number) in the specification of the application, or any 
application the benefit of whose filing date is sought under title 35, 
United States Code, there is written description support for the 
invention as defined in the claims (whether in independent or dependent 
form), and of the manner and process of making and using it, in such 
full, clear, concise, and exact terms as to enable any person skilled 
in the art to which it pertains, or with which it is most nearly 
connected, to make and use the invention, under the first paragraph of 
35 U.S.C. 112.
* * * * *

0
11. Section 1.110 is revised to read as follows:


Sec.  1.110  Inventorship and date of invention of the subject matter 
of individual claims.

    When more than one inventor is named in an application or patent, 
the Office may require an applicant, patentee, or owner to identify the 
inventive entity of the subject matter of each claim in the application 
or patent when necessary for purposes of an Office proceeding. Where 
appropriate, the invention dates of the subject matter of each claim 
and the ownership of the subject matter on the date of invention may be 
required of the applicant, patentee or owner. See also Sec. Sec.  1.78 
and 1.130.
0
12. Section 1.114 is amended by revising paragraphs (a) and (d), and by 
adding new paragraphs (f), (g), and (h), to read as follows:


Sec.  1.114  Request for continued examination.

    (a) If prosecution in an application is closed, an applicant may, 
subject to the conditions of this section, file a request for continued 
examination of the application accompanied by a submission, the fee set 
forth in Sec.  1.17(e), and if required, a petition under paragraph (g) 
of this section accompanied by the fee set forth in Sec.  1.17(f), 
prior to the earliest of:
    (1) Payment of the issue fee, unless a petition under Sec.  1.313 
is granted;
    (2) Abandonment of the application; or
    (3) The filing of a notice of appeal to the U.S. Court of Appeals 
for the Federal Circuit under 35 U.S.C. 141, or the commencement of a 
civil action under 35 U.S.C. 145 or 146, unless the appeal or civil 
action is terminated.
* * * * *
    (d) If an applicant files a request for continued examination under 
this section after appeal, but prior to a decision on the appeal, the 
request for continued examination will also be treated as a request to 
withdraw the appeal and to reopen prosecution of the application before 
the examiner. An appeal brief (Sec.  41.37 of this title), a reply 
brief (Sec.  41.41 of this title), or related papers will not be 
considered a submission under this section.
* * * * *
    (f) An applicant may file a request for continued examination under 
this section in an application without a petition under paragraph (g) 
of this section if the conditions set forth in at least one of 
paragraphs (f)(1), (f)(2), or (f)(3) of this section are satisfied:
    (1) A request for continued examination under this section has not 
previously been filed in any of:
    (i) The application;
    (ii) Any application whose benefit is claimed under 35 U.S.C. 120, 
121, or 365(c) in such application; and
    (iii) Any application that claims the benefit under 35 U.S.C. 120, 
121, or 365(c) of such application, not including any nonprovisional 
application that satisfies the conditions set forth in Sec.  
1.78(d)(1)(ii), (d)(1)(iii) or (d)(1)(vi).
    (2) The application is a divisional application that satisfies the 
conditions set forth in Sec.  1.78(d)(1)(ii), and a request for 
continued examination under this section has not previously been filed 
in any of:
    (i) The divisional application; and
    (ii) Any application that claims the benefit under 35 U.S.C. 120, 
121, or 365(c) of such divisional application, not including any 
nonprovisional application that satisfies the conditions set forth in 
Sec.  1.78(d)(1)(ii), (d)(1)(iii) or (d)(1)(vi).
    (3) The application is a continuation application that claims the 
benefit under 35 U.S.C. 120, 121, or 365(c) of a divisional application 
and satisfies the conditions set forth in Sec.  1.78(d)(1)(iii), and a 
request for continued examination under this section has not been filed 
in any of:
    (i) The continuation application;
    (ii) The divisional application; and
    (iii) Any other application that claims the benefit under 35 U.S.C. 
120, 121, or 365(c) of such divisional application, not including any 
nonprovisional application that satisfies the conditions set forth in 
Sec.  1.78(d)(1)(ii), (d)(1)(iii) or (d)(1)(vi).
    (g) A request for continued examination must include a petition 
accompanied by the fee set forth in Sec.  1.17(f) and a showing that 
the amendment, argument, or evidence sought to be entered could not 
have been submitted prior to the close of prosecution in the 
application, except as otherwise provided in paragraph (f) of this 
section.
    (h) The filing of an improper request for continued examination, 
including a request for continued examination with a petition under 
paragraph (g) of this section that is not grantable, will not stay any 
period for reply that may be running against the application, nor act 
as a stay of other proceedings.

0
13. Section 1.117 is added to read as follows:

[[Page 46842]]

Sec.  1.117  Refund due to cancellation of claim.

    (a) If an amendment canceling a claim is filed before an 
examination on the merits has been made of the application, the 
applicant may request a refund of any fee under Sec.  1.16(h), (i), or 
(j) or under Sec.  1.492(d), (e), or (f) paid on or after December 8, 
2004, for such claim. If an amendment adding one or more claims is also 
filed before the application has been taken up for examination on the 
merits, the Office may apply any refund under Sec.  1.117 to any excess 
claims fees due as a result of such an amendment. The date indicated on 
any certificate of mailing or transmission under Sec.  1.8 will not be 
taken into account in determining whether an amendment canceling a 
claim was filed before an examination on the merits has been made of 
the application.
    (b) If a request for refund under this section is not filed within 
two months from the date on which the claim was canceled, the Office 
may retain the excess claims fee paid in the application. This two-
month period is not extendable. If an amendment canceling a claim is 
not filed before an examination on the merits has been made of the 
application, the Office will not refund any part of the excess claims 
fee paid in the application except as provided in Sec.  1.26.

0
14. Section 1.136 is amended by revising paragraph (a)(1) to read as 
follows:


Sec.  1.136  Extensions of time.

    (a)(1) If an applicant is required to reply within a nonstatutory 
or shortened statutory time period, applicant may extend the time 
period for reply up to the earlier of the expiration of any maximum 
period set by statute or five months after the time period set for 
reply, if a petition for an extension of time and the fee set in Sec.  
1.17(a) are filed, unless:
    (i) Applicant is notified otherwise in an Office action;
    (ii) The reply is to a notice requiring compliance with Sec.  
1.75(b) or Sec.  1.265;
    (iii) The reply is a reply brief submitted pursuant to Sec.  41.41 
of this title;
    (iv) The reply is a request for an oral hearing submitted pursuant 
to Sec.  41.47(a) of this title;
    (v) The reply is to a decision by the Board of Patent Appeals and 
Interferences pursuant to Sec.  1.304 or to Sec.  41.50 or Sec.  41.52 
of this title; or
    (vi) The application is involved in a contested case (Sec.  
41.101(a) of this title).
* * * * *

0
15. Section 1.142 is amended by revising paragraph (a) and adding new 
paragraph (c) to read as follows:


Sec.  1.142  Requirement for restriction.

    (a) If two or more independent and distinct inventions are claimed 
in a single application, the examiner in an Office action may require 
the applicant in the reply to that action to elect an invention to 
which the claims will be restricted, this official action being called 
a requirement for restriction (also known as a requirement for 
division). Such requirement will normally be made before any action on 
the merits; however, it may be made at any time before final action.
* * * * *
    (c) If two or more independent and distinct inventions are claimed 
in a single application, the applicant may file a suggested requirement 
for restriction under this paragraph. Any suggested requirement for 
restriction must be filed prior to the earlier of the first Office 
action on the merits or an Office action that contains a requirement to 
comply with the requirement of unity of invention under PCT Rule 13 or 
a requirement for restriction under 35 U.S.C. 121 in the application. 
Any suggested requirement for restriction must also be accompanied by 
an election without traverse of an invention to which there are no more 
than five independent claims and no more than twenty-five total claims, 
and must identify the claims to the elected invention. If the suggested 
requirement for restriction is accepted, the applicant will be notified 
in an Office action that will contain a requirement for restriction 
under paragraph (a) of this section. Any claim to the non-elected 
invention or inventions, if not canceled, is by the election withdrawn 
from further consideration.

0
16. Section 1.145 is revised to read as follows:


Sec.  1.145  Subsequent presentation of claims for different invention.

    If, after an Office action on the merits on an application, the 
applicant presents claims directed to an invention distinct from and 
independent of the invention previously claimed, the applicant may be 
required to restrict the claims to the invention previously claimed if 
the amendment is entered, subject to reconsideration and review as 
provided in Sec. Sec.  1.143 and 1.144.

0
17. Section 1.265 is added to read as follows:


Sec.  1.265  Examination support document.

    (a) An examination support document as used in this part means a 
document that includes the following:
    (1) A statement that a preexamination search in compliance with 
paragraph (b) of this section was conducted, including an 
identification of the field of search by United States class and 
subclass and the date of the search, where applicable, and, for 
database searches, the search logic or chemical structure or sequence 
used as a query, the name of the file or files searched and the 
database service, and the date of the search;
    (2) A listing of the reference or references deemed most closely 
related to the subject matter of each of the claims (whether in 
independent or dependent form) in compliance with paragraph (c) of this 
section;
    (3) For each reference cited, an identification of all of the 
limitations of each of the claims (whether in independent or dependent 
form) that are disclosed by the reference;
    (4) A detailed explanation particularly pointing out how each of 
the independent claims is patentable over the cited references; and
    (5) A showing of where each limitation of each of the claims 
(whether in independent or dependent form) finds support under the 
first paragraph of 35 U.S.C. 112 in the written description of the 
specification. If the application claims the benefit of one or more 
applications under title 35, United States Code, the showing must also 
include where each limitation of each of the claims finds support under 
the first paragraph of 35 U.S.C. 112 in each such priority or benefit 
application in which such support exists.
    (b) The preexamination search referred to in paragraph (a)(1) of 
this section must involve U.S. patents and patent application 
publications, foreign patent documents, and non-patent literature, 
unless the applicant justifies with reasonable certainty that no 
references more pertinent than those already identified are likely to 
be found in the eliminated source and includes such a justification 
with the statement required by paragraph (a)(1) of this section. The 
preexamination search referred to in paragraph (a)(1) of this section 
must be directed to the claimed invention and encompass all of the 
limitations of each of the claims (whether in independent or dependent 
form), giving the claims the broadest reasonable interpretation.
    (c) The listing of references required under paragraph (a)(2) of 
this section as part of an examination support document must include a 
list identifying each of the cited references

[[Page 46843]]

in compliance with paragraphs (c)(1) and (c)(2) of this section, a copy 
of each reference if required by paragraph (c)(3) of this section, and 
each English language translation if required by paragraph (c)(4) of 
this section.
    (1) The list of cited references must itemize U.S. patents and U.S. 
patent application publications (including international applications 
designating the U.S.) in a section separate from the list of other 
references. Each page of the list of the cited references must include:
    (i) The application number, if known, of the application in which 
the examination support document is being filed;
    (ii) A column that provides a space next to each cited reference 
for the examiner's initials; and
    (iii) A heading that clearly indicates that the list is part of an 
examination support document listing of references.
    (2) The list of cited references must identify each cited reference 
as follows:
    (i) Each U.S. patent must be identified by first named patentee, 
patent number, and issue date.
    (ii) Each U.S. patent application publication must be identified by 
applicant, patent application publication number, and publication date.
    (iii) Each U.S. application must be identified by the applicant, 
application number, and filing date.
    (iv) Each foreign patent or published foreign patent application 
must be identified by the country or patent office which issued the 
patent or published the application, an appropriate document number, 
and the publication date indicated on the patent or published 
application.
    (v) Each publication must be identified by publisher (e.g., name of 
journal), author (if any), title, relevant pages of the publication, 
date, and place of publication.
    (3) The listing of references required under paragraph (a)(2) of 
this section must also be accompanied by a legible copy of each cited 
reference, except for references that are U.S. patents or U.S. patent 
application publications.
    (4) If a non-English language document is being cited in the 
listing of references required under paragraph (a)(2) of this section 
as part of an examination support document, any existing English 
language translation of the non-English language document must also be 
submitted if the translation is within the possession, custody, or 
control of, or is readily available to any individual identified in 
Sec.  1.56(c).
    (d) If an information disclosure statement is filed in an 
application in which an examination support document is required and 
has been filed, the applicant must also file a supplemental examination 
support document addressing the reference or references in the manner 
required under paragraphs (a)(3) and (a)(4) of this section unless the 
information disclosure statement cites only references that are less 
closely related to the subject matter of one or more claims (whether in 
independent or dependent form) than the references cited in the 
examination support document listing of references under paragraph 
(a)(2) of this section.
    (e) If an examination support document is required, but the 
examination support document or preexamination search is deemed to be 
insufficient, or the claims have been amended such that the examination 
support document no longer covers each of the claims, applicant will be 
notified and given a two-month time period that is not extendable under 
Sec.  1.136(a) within which, to avoid abandonment of the application, 
the applicant must:
    (1) File a corrected or supplemental examination support document 
in compliance with this section that covers each of the claims (whether 
in independent or dependent form); or
    (2) Amend the application such that it contains no more than five 
independent claims and no more than twenty-five total claims.
    (f) An examination support document, or a corrected or supplemental 
examination support document, is not required to comply with the 
requirements set forth in paragraph (a)(3) of this section if the 
examination support document is accompanied by a certification that any 
rights in the application have not been assigned, granted, conveyed, or 
licensed, and there is no obligation under contract or law to assign, 
grant, convey, or license any rights in the application, other than a 
security interest that has not been defaulted upon, to any entity other 
than:
    (1) A business or other concern:
    (i) Whose number of employees, including affiliates, does not 
exceed 500 persons; and
    (ii) Which has not assigned, granted, conveyed, or licensed (and is 
under no obligation to do so) any rights in the invention to any person 
who made it and could not be classified as an independent inventor, or 
to any concern which would not qualify as a non-profit organization or 
a small business concern under paragraph (f)(1)(i) of this section.
    (2) A not-for-profit enterprise which is independently owned and 
operated and is not dominant in its field; or
    (3) A government of a city, county, town, township, village, school 
district, or special district, with a population of less than fifty 
thousand.

0
18. Section 1.495 is amended by revising paragraph (g) to read as 
follows:


Sec.  1.495  Entering the national stage in the United States of 
America.

* * * * *
    (g) The documents and fees submitted under paragraphs (b) and (c) 
of this section must be clearly identified as a submission to enter the 
national stage under 35 U.S.C. 371. If the documents and fees contain 
conflicting indications as between an application under 35 U.S.C. 111 
and a submission to enter the national stage under 35 U.S.C. 371, the 
documents and fees will be treated as a submission to enter the 
national stage under 35 U.S.C. 371.
* * * * *

0
19. Section 1.704 is amended by redesignating paragraph (c)(11) as 
(c)(12) and adding new paragraph (c)(11) to read as follows:


Sec.  1.704  Reduction of period of adjustment of patent term.

* * * * *
    (c) * * *
    (11) Failure to comply with Sec.  1.75(b), in which case the period 
of adjustment set forth in Sec.  1.703 shall be reduced by the number 
of days, if any, beginning on the day after the date that is the later 
of the filing date of the amendment resulting in the non-compliance 
with Sec.  1.75(b), or four months from the filing date of the 
application in an application under 35 U.S.C. 111(a) or from the date 
on which the national stage commenced under 35 U.S.C. 371(b) or (f) in 
an application which entered the national stage from an international 
application after compliance with 35 U.S.C. 371, and ending on the date 
that an examination support document in compliance with Sec.  1.265, an 
election in reply to a requirement under Sec.  1.142(a), 1.146 or 1.499 
resulting in compliance with Sec.  1.75(b), an amendment resulting in 
compliance with Sec.  1.75(b), or a suggested restriction requirement 
in compliance with Sec.  1.142(c), was filed;
* * * * *

    Dated: August 2, 2007.
Jon W. Dudas,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
 [FR Doc. E7-15565 Filed 8-20-07; 8:45 am]
BILLING CODE 3510-16-P