[Federal Register Volume 69, Number 78 (Thursday, April 22, 2004)]
[Rules and Regulations]
[Pages 21704-21711]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-9144]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No.: 2003-P-029]
RIN 0651-AB71


Revision of Patent Term Extension and Patent Term Adjustment 
Provisions

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Final rule.

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

SUMMARY: The patent term extension provisions of the Uruguay Round 
Agreements Act (URAA) and the patent term adjustment provisions of the 
American Inventors Protection Act of 1999 (AIPA) each provide for the 
possibility of patent term extension or adjustment if the issuance of 
the patent was delayed due to review by the Board of Patent Appeals and 
Interferences (BPAI) or by a Federal court and the patent was issued 
pursuant to or under a decision in the review reversing an adverse 
determination of patentability. The United States Patent and Trademark 
Office (Office) is revising the rules of practice in patent cases to 
indicate that under certain circumstances a panel remand by the BPAI 
shall be considered a decision in the review reversing an adverse 
determination of patentability for purposes of patent term extension or 
patent term adjustment. The Office is also adopting other miscellaneous 
changes to the patent term adjustment provisions of the rules of 
practice.

DATES: Effective Date: May 24, 2004.
    Any request for reconsideration of the patent term extension or 
adjustment indicated on a patent resulting from an application in which 
the notice of

[[Page 21705]]

allowance was mailed before May 24, 2004 on the basis of the changes to 
37 CFR 1.701 or 1.702 in this final rule must be filed no later than 
July 21, 2004.

FOR FURTHER INFORMATION CONTACT: Kery A. Fries, Legal Advisor, Office 
of Patent Legal Administration, by telephone at (703) 305-1383, by mail 
addressed to: Box Comments--Patents, Commissioner for Patents, P.O. Box 
1450, Alexandria, VA 22313-1450, or by facsimile to (703) 746-3240, 
marked to the attention of Kery A. Fries.

SUPPLEMENTARY INFORMATION: Section 532(a) of the URAA (Pub. L. 103-465, 
108 Stat. 4809 (1994)) amended 35 U.S.C. 154 to provide that the term 
of a patent ends on the date that is twenty years from the filing date 
of the application, or the earliest filing date for which a benefit is 
claimed under 35 U.S.C. 120, 121, or 365(c). Public Law 103-465 also 
contained provisions, codified at 35 U.S.C. 154(b), for patent term 
extension due to certain examination delays. The Office implemented the 
patent term extension provisions of the URAA in a final rule published 
in April of 1995. See Changes to Implement 20-Year Patent Term and 
Provisional Applications, 60 FR 20195 (Apr. 25, 1995), 1174 Off. Gaz. 
Pat. Office 15 (May 2, 1995) (final rule).
    The AIPA (Pub. L. 106-113, 113 Stat. 1501, 1501A-552 through 1501A-
591 (1999)) further amended 35 U.S.C. 154(b) to include additional 
bases for patent term extension (characterized as ``patent term 
adjustment'' in the AIPA). Original utility and plant patents issuing 
from applications filed on or after May 29, 2000, may be eligible for 
patent term adjustment if issuance of the patent is delayed due to one 
or more of the enumerated administrative delays listed in 35 U.S.C. 
154(b)(1). The Office implemented the patent term adjustment provisions 
of the AIPA in a final rule published in September of 2000. See Changes 
to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 
FR 56365 (Sept. 18, 2000), 1239 Off. Gaz. Pat. Office 14 (Oct. 3, 2000) 
(final rule). The patent term adjustment provisions of the AIPA apply 
to original (i.e., non-reissue) utility and plant applications filed on 
or after May 29, 2000. See Changes to Implement Patent Term Adjustment 
Under Twenty-Year Patent Term, 65 FR at 56367, 1239 Off. Gaz. Pat. 
Office at 14-15. The patent term extension provisions of the URAA (for 
delays due to secrecy order, interference or successful appellate 
review) continue to apply to original utility and plant applications 
filed on or after June 8, 1995, and before May 29, 2000. See id.
    The Office is amending the rules of practice in patent cases to 
indicate that certain remands by the BPAI shall be considered ``a 
decision in the review reversing an adverse determination of 
patentability'' for patent term adjustment and patent term extension 
purposes. Specifically, if an application is remanded by a panel of the 
BPAI and the remand is the last action by a BPAI panel prior to the 
mailing of a notice of allowance under 35 U.S.C. 151 in the 
application, the remand shall be considered a decision reversing an 
adverse determination of patentability for patent term adjustment and 
patent term extension purposes. However, a panel remand shall not be 
considered a decision in the review reversing an adverse determination 
of patentability if there is filed a request for continued examination 
under 35 U.S.C. 132(b) (Sec.  1.114) that was not first preceded by the 
mailing, after such remand, of at least one of an action under 35 
U.S.C. 132 or a notice of allowance under 35 U.S.C. 151.
    The term ``panel'' of the BPAI means a panel comprised of members 
of the BPAI as defined in 35 U.S.C. 6(a). The phrase ``remanded by a 
panel'' of the BPAI does not pertain to a remand or order returning an 
appeal to the examiner issued by a BPAI administrator. See e.g., 
Revised Docketing Procedures for Appeals Arriving at the Board of 
Patent Appeals and Interferences, 1260 Off. Gaz. Pat. Office 18 (July 
2, 2002). The phrase ``remanded by a panel'' of the BPAI also does not 
pertain to a remand or order returning an appeal to the examiner that 
is issued by a BPAI administrator subsequent to the issuance of a 
docketing notice.
    The Office initially took the position that a remand by a BPAI 
panel was not a ``decision'' within the meaning of 35 U.S.C. 
154(b)(1)(A)(iii), much less ``a decision reversing an adverse 
determination of patentability'' as that phrase is used in 35 U.S.C. 
154(b)(1)(C)(iii). See Changes to Implement Patent Term Adjustment 
Under Twenty-Year Patent Term, 65 FR at 56369, 1239 Off. Gaz. Pat. 
Office at 16. The Office has subsequently determined that there are a 
number of BPAI panel remands that convey the weakness in the examiner's 
adverse patentability determination in a manner tantamount to a 
decision reversing the adverse patentability determination. Such a BPAI 
panel remand generally results in the examiner allowing the application 
(either with or without further action by applicant) without returning 
the application with a response to the issues raised in the remand to 
the BPAI for a decision on the appeal. The changes in this final rule 
address the situation in which an examiner responds to a remand by a 
BPAI panel by allowing the application (either with or without further 
action by applicant), rather than returning the application with a 
response to the issues raised in the remand to the BPAI for a decision 
on the appeal. In this situation, the BPAI panel remand shall be 
considered ``a decision in the review reversing an adverse 
determination of patentability'' for patent term extension and patent 
term adjustment purposes. The changes in this final rule, however, will 
not apply if, after the BPAI panel remand, there is filed a request for 
continued examination under 35 U.S.C. 132(b) (Sec.  1.114) that was not 
first preceded by the mailing, after such remand, of at least one of an 
action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 
151.
    If the patent issues after a remand that is considered ``a decision 
in the review reversing an adverse determination of patentability,'' 
the BPAI panel remand is deemed by the Office to be the ``final 
decision in favor of the applicant'' for purposes of a patent term 
extension or adjustment calculation under Sec.  1.701(c)(3) or Sec.  
1.703(e) (as applicable). The period of extension or adjustment 
calculated under Sec.  1.701(c)(3) or Sec.  1.703(e) (as applicable) 
would equal the number of days in the period beginning on the date on 
which a notice of appeal to the BPAI was filed under 35 U.S.C. 134 and 
Sec.  1.191 and ending on the mailing date of the BPAI panel remand.
    The Office also proposed changes to Sec. Sec.  1.704 and 1.705 in a 
rule making to implement portions of the Office's 21st Century 
Strategic Plan. See Changes to Support Implementation of the United 
States Patent and Trademark Office 21st Century Strategic Plan, 68 FR 
53816, 53843, 53857-58 (Sept. 12, 2003), 1275 Off. Gaz. Pat. Office 23, 
45-46, 60 (Oct. 7, 2003) (proposed rule) (hereinafter ``21st Century 
Strategic Plan notice of proposed rule making''). The Office is 
adopting changes to Sec. Sec.  1.704 and 1.705 proposed in the 21st 
Century Strategic Plan notice of proposed rule making in this final 
rule so that all changes to the patent term adjustment provisions of 
the rule of practice currently under consideration will be adopted in 
the same final rule.

Discussion of Specific Rules

    Section 1.701: Section 1.701(a)(3) is amended by adding the 
following sentence: If an application is remanded by a panel of the 
Board of Patent Appeals and Interferences and the

[[Page 21706]]

remand is the last action by a panel of the Board of Patent Appeals and 
Interferences prior to the mailing of a notice of allowance under 35 
U.S.C. 151 in the application, the remand shall be considered a 
decision in the review reversing an adverse determination of 
patentability as that phrase is used in 35 U.S.C. 154(b)(2) as amended 
by section 532(a) of the Uruguay Round Agreements Act, Public Law 103-
465, 108 Stat. 4809, 4983-85 (1994), and a final decision in favor of 
the applicant under Sec.  1.701(c)(3). Section 1.701(a)(3) is also 
amended to provide that a panel remand shall not be considered a 
decision in the review reversing an adverse determination of 
patentability as provided in Sec.  1.701(a)(3) if there is filed a 
request for continued examination under 35 U.S.C. 132(b) (Sec.  1.114) 
that was not first preceded by the mailing, after such remand, of at 
least one of an action under 35 U.S.C. 132 or a notice of allowance 
under 35 U.S.C. 151. Section 1.701(a)(3) is also amended to change 
``decision reversing an adverse determination of patentability'' to 
``decision in the review reversing an adverse determination of 
patentability'' for consistency with 35 U.S.C. 154(b)(2) as amended by 
section 532(a) of the URAA.
    Section 1.702: Section 1.702(e) is amended by adding the following 
sentence: If an application is remanded by a panel of the Board of 
Patent Appeals and Interferences and the remand is the last action by a 
panel of the Board of Patent Appeals and Interferences prior to the 
mailing of a notice of allowance under 35 U.S.C. 151 in the 
application, the remand shall be considered a decision by the Board of 
Patent Appeals and Interferences as that phrase is used in 35 U.S.C. 
154(b)(1)(A)(iii), a decision in the review reversing an adverse 
determination of patentability as that phrase is used in 35 U.S.C. 
154(b)(1)(C)(iii), and a final decision in favor of the applicant under 
Sec.  1.703(e). Section 1.702(e) is also amended to provide that a 
panel remand shall not be considered a decision in the review reversing 
an adverse determination of patentability as provided in Sec.  1.702(e) 
if there is filed a request for continued examination under 35 U.S.C. 
132(b) (Sec.  1.114) that was not first preceded by the mailing, after 
such remand, of at least one of an action under 35 U.S.C. 132 or a 
notice of allowance under 35 U.S.C. 151. Section 1.702(e) is also 
amended to change ``decision reversing an adverse determination of 
patentability'' to ``decision in the review reversing an adverse 
determination of patentability'' for consistency with 35 U.S.C. 
154(b)(1)(C)(iii).
    Section 1.703: Section 1.703(f) is amended to change ``[t]o the 
extent that periods of adjustment attributable to the grounds specified 
in Sec.  1.702 overlap'' to ``[t]o the extent that periods of delay 
attributable to the grounds specified in Sec.  1.702 overlap'' for 
consistency with 35 U.S.C. 154(b)(2)(A). The language of former Sec.  
1.703(f) misled applicants into believing that delays under 35 U.S.C. 
154(b)(1)(A) (Sec. Sec.  1.702(a) and 1.703(a)) and delays under 35 
U.S.C. 154(b)(1)(B) (Sec. Sec.  1.702(b) and 1.703(b)) were overlapping 
only if the period of delay under 35 U.S.C. 154(b)(1)(A) occurred more 
than three years after the actual filing date of the application. If an 
application is entitled to an adjustment under 35 U.S.C. 154(b)(1)(B), 
the entire period during which the application was pending before the 
Office (except for periods excluded under 35 U.S.C. 154(b)(1)(B)(i)-
(iii)), and not just the period beginning three years after the actual 
filing date of the application, is the period of delay under 35 U.S.C. 
154(b)(1)(B) in determining whether periods of delay overlap under 35 
U.S.C. 154(b)(2)(A).
    Section 1.704: Section 1.704(d) is amended to change ``cited in a 
communication'' to ``first cited in any communication'' in order to 
clarify that the item must have been first cited in any communication 
from a foreign patent office in a counterpart application instead of 
merely being cited in such a communication. An applicant who fails to 
cite an item, within thirty days of receipt by an individual designated 
in Sec.  1.56(c) of a first communication from a foreign patent office 
in a counterpart application citing the item, and instead files an 
information disclosure statement, within thirty days of a subsequent 
communication citing the item, cannot be considered to have acted with 
reasonable efforts to conclude prosecution of the application. The 
change to require that this thirty-day time period run from a first 
communication parallels the corresponding language in Sec.  1.97(e)(1). 
The provisions of Sec.  1.704(d) do not apply if the applicant does not 
submit the information disclosure statement within thirty days of a 
first communication including a citation of an item to a party 
designated in Sec.  1.56(c). In such situations, the submission of an 
information disclosure statement may be considered a failure to engage 
in reasonable efforts to conclude prosecution (processing or 
examination) of the application under Sec.  1.704(c)(6), (c)(8), 
(c)(9), or (c)(10).
    Section 1.705: Section 1.705(d) is amended to provide that a 
patentee may request reconsideration of the patent term adjustment 
within two months of the date the patent issued if the patent indicates 
a revised patent term adjustment relative to the patent term adjustment 
indicated on the notice of allowance. The Office currently includes the 
patent term adjustment information that will be printed on the face of 
the patent on the Issue Notification. See Changes to Implement Patent 
Term Adjustment Under Twenty-Year Patent Term, 65 FR at 56388, 1239 
Off. Gaz. Pat. Office at 33 (response to comment 49). The Office plans 
to discontinue the practice of including patent term adjustment 
information on the Issue Notification, but is changing the period for 
filing a request for reconsideration under Sec.  1.705(d) of the patent 
term adjustment indicated in the patent from thirty days to two months. 
This two-month period in Sec.  1.705(d) is non-extendable. See Sec.  
1.705(e).
    The Patent Application Locating and Monitoring (PALM) system 
maintains computerized contents records of all patent applications and 
reexaminations. The Patent Application Information and Retrieval (PAIR) 
system provides public access to PALM for patents and applications that 
have been published (i.e., applications no longer being maintained in 
confidence), which can be accessed over the Internet at http://pair.uspto.gov. The PAIR system also has a private side (http://pair-direct.uspto.gov) which may be used by an applicant to access 
confidential information about his or her pending application. See 
Clarification of 37 CFR 1.704(c)(10)--Reduction of Patent Term 
Adjustment for Certain Types of Papers Filed After a Notice of 
Allowance has been Mailed, 1247 Off. Gaz. Pat. Office 111, 112 (June 
26, 2001). While the Office plans to discontinue the practice of 
including patent term adjustment information on the Issue Notification, 
applicants can check PAIR to see the Office's current patent term 
adjustment determination upon receipt of the Issue Notification to 
ascertain whether the patent term adjustment determination has been 
revised since the mailing of the notice of allowance.
    Section 1.705(d) is also amended to permit a patentee to file the 
request for reconsideration if the patent indicates or should have 
indicated a revised patent term adjustment of a revision to patent term 
adjustment indicated in the notice of allowance. Section 1.705(d) 
formerly provided that a request for reconsideration under Sec.  
1.705(d) was limited to the situation where the patent issues on a date 
other than the projected

[[Page 21707]]

date of issue. There are a number of papers which if submitted by an 
applicant after the mailing of the notice of allowance will result in a 
reduction of any patent term adjustment, such as: (1) Request for 
refunds; (2) status letter; (3) amendments under Sec.  1.312; (4) late 
priority claims; (5) a certified copy of a priority document; (6) 
drawings; (7) letters related to biological deposits; and (8) oaths or 
declarations. See Sec.  1.704(c)(10). In addition, receipt of the 
payment of the issue fee more than three months after mailing of the 
notice of allowance will also result in a reduction of any patent term 
adjustment. See Sec.  1.704(b) and Sec.  1.703(f) (``[t]he date 
indicated on any certificate of mailing or transmission under Sec.  1.8 
shall not be taken into account in this calculation''). There are also 
Office delays that may occur after the mailing of the notice of 
allowance which may result in an increase in the amount of patent term 
adjustment, such as the failure to issue the patent within four months 
after the date the issue fee was paid under 35 U.S.C. 151 and all 
outstanding requirements were satisfied, or the failure to issue the 
patent within three years after the date on which an application was 
filed under 35 U.S.C. 111(a). See Sec.  1.702(a)(4) and Sec.  1.702(b).
    Section 1.705(d) is also amended to provide that any request for 
reconsideration under Sec.  1.705(d) that raises issues that were 
raised, or could have been raised, in an application for patent term 
adjustment under Sec.  1.704(b) shall be dismissed as untimely as to 
those issues. The purpose of Sec.  1.705(d) is to provide patentees 
with an avenue to obtain reconsideration of the patent term adjustment 
indicated in the patent when the patent term adjustment indicated in 
the patent differs or should have differed from the patent term 
adjustment indicated in the notice of allowance due to events occurring 
after the mailing of the notice of allowance. Section 1.705(d) is not 
an avenue for patentees to seek review of issues that were raised, or 
could have been raised, in an application for patent term adjustment 
under Sec.  1.704(b). Any request for reconsideration of the patent 
term adjustment indicated in the patent on the basis of issues that 
were raised, or could have been raised, in an application for patent 
term adjustment under Sec.  1.704(b) is considered untimely if not 
filed within the period specified in Sec.  1.705(b).
    Requests for reconsideration of patent term adjustment 
determinations indicated in notice of allowances and patents under 35 
U.S.C. 154(b) and Sec. Sec.  1.702 through 1.704 are provided for in 
Sec.  1.705. Petitions under Sec.  1.182 or 1.183, or requests for a 
certificate of correction under either 35 U.S.C. 254 and Sec.  1.323 or 
35 U.S.C. 255 and Sec.  1.324, are not substitute fora to obtain 
reconsideration of a patent term adjustment determination indicated in 
a notice of allowance if an applicant fails to submit a request for 
reconsideration within the time period specified in Sec.  1.705(b), or 
to obtain reconsideration of a patent term adjustment determination 
indicated in a patent if a patentee fails to submit a request for 
reconsideration within the time period specified in Sec.  1.705(d).
    Response to comments: The Office published a notice proposing 
changes to the rules of practice to provide that under certain 
circumstances a panel remand by the BPAI shall be considered a decision 
in the review reversing an adverse determination of patentability for 
purposes of patent term extension or patent term adjustment. See 
Revision of Patent Term Extension and Patent Term Adjustment Provisions 
Related to Decisions by the Board of Patent Appeals and Interferences 
68 FR 67818 (Dec. 4, 2003), 1277 Off. Gaz. Pat. Office 227 (Dec. 30, 
2003) (proposed rule). The Office received seven written comments (from 
an intellectual property organization, a law firm, a business, and 
patent practitioners) in response to this notice of proposed rule 
making. The Office also received five written comments concerning 
Sec. Sec.  1.704 and 1.705 in response to the 21st Century Strategic 
Plan notice of proposed rule making. Comments generally in support of a 
change are not discussed. The comments and the Office's responses to 
those comments follow:
    Comment 1: One comment questioned whether the Office has the 
authority to interpret a remand from the BPAI as a decision by the BPAI 
reversing an adverse determination of patentability. The comment 
suggested that the Office should amend the rules of practice to permit 
the BPAI to designate a remand as a decision by the BPAI reversing an 
adverse determination of patentability.
    Response: 35 U.S.C. 2(b)(2) provides that the Office may establish 
regulations, not inconsistent with law, which shall govern the conduct 
of proceedings in the Office, 35 U.S.C. 3(a)(2)(A) provides that the 
Director is responsible for providing policy direction and management 
supervision for the Office, and 35 U.S.C. 154(b)(3)(A) provides that 
the Director shall prescribe regulations establishing procedures for 
the application for and determination of patent term adjustments under 
35 U.S.C. 154(b). Therefore, the Office has sufficient rule making 
authority to promulgate regulations to avoid situations in which an 
applicant is deprived of patent term extension or adjustment because a 
BPAI panel designates a decision as a remand rather than as a reversal 
coupled with a remand.
    Comment 2: One comment suggested that the Office should amend the 
rules of practice to permit the BPAI to designate a remand as a 
decision by the BPAI reversing an adverse determination of 
patentability.
    Response: It is unnecessary to amend the rules of practice to 
provide that a BPAI panel may designate a remand as a decision by the 
BPAI reversing an adverse determination of patentability. First, a BPAI 
panel may do so in essence by designating the decision as a reversal 
coupled with a remand. Second, a BPAI panel remand will be considered a 
``decision in the review reversing an adverse determination of 
patentability'' under Sec.  1.701(a)(3) or Sec.  1.702(e) as amended in 
this final rule if the remand is the last action by a panel of the 
Board of Patent Appeals and Interferences prior to the mailing of a 
notice of allowance under 35 U.S.C. 151 in the application (except if 
there is filed a request for continued examination under 35 U.S.C. 
132(b) (Sec.  1.114) that was not first preceded by the mailing, after 
such remand, of at least one of an action under 35 U.S.C. 132 or a 
notice of allowance under 35 U.S.C. 151.).
    Comment 3: One comment suggested that the Office should treat a 
remand by a BPAI administrator the same as a remand by a BPAI panel in 
determining whether the remand is considered a decision in the review 
reversing an adverse determination of patentability for patent term 
extension and adjustment purposes.
    Response: The Office cannot treat a remand or other order by an 
administrator as a ``decision in the review reversing an adverse 
determination of patentability'' for patent term extension or 
adjustment purposes because an administrator is not a member of the 
BPAI as defined in 35 U.S.C. 6(a) and because 35 U.S.C. 6(b) requires 
that appeals be heard by at least three members of the BPAI. While the 
Office has proposed to define BPAI as including a BPAI member or 
employee acting with the authority of the BPAI for certain purposes 
(proposed Sec.  41.2(2)), the Office has cautioned that this definition 
of ``BPAI'' is not applicable in a situation in which action by a BPAI 
panel is required by statute, and has also proposed to define BPAI 
member as a member of the BPAI as set forth in 35 U.S.C. 6(a) (proposed 
Sec.  41.2(3)). See Rules of Practice Before the Board of Patent 
Appeals and

[[Page 21708]]

Interferences, 68 FR 66647, 66649 (Nov. 26, 2003), 1277 Off. Gaz. Pat. 
Office 157, 159 (Dec. 23, 2003) (proposed rule).
    Comment 4: Several comments suggested that the filing of an 
information disclosure statement or certain amendments should not 
preclude a remand from being considered a decision in the review 
reversing an adverse determination of patentability for patent term 
extension or adjustment purposes. The comments provided the following 
examples of amendments that should not preclude a remand from being 
considered a decision in the review reversing an adverse determination 
of patentability for patent term extension or adjustment purposes: (1) 
Amendments which only correct formal matters (e.g., update the address 
of a depository such as the American Type Culture Collection (ATCC); 
(2) amendments which improve the clarity of the claims; (3) amendments 
which rejoin claims that were withdrawn pending the allowance of a 
product claim; (4) amendments which only define the claims over newly 
cited prior art; (5) an examiner's amendment or examiner requested 
amendment; (6) amendments that do not address the merits of the claims; 
(7) amendments that change the title or abstracts to correspond to all 
of the allowed claims; (8) inconsistencies between reference characters 
used in the specification and those used in the drawings; (9) 
inconsistent case use of pronouns; (10) resubmission of documents that 
were lost by the Office; (11) amendments which incorporate limitations 
from a dependent claim into an independent claim; and (12) any 
amendment so long as at least one previously rejected claim is allowed 
in unamended form. One comment suggested that if an information 
disclosure statement contains a certification under Sec.  1.704(d), the 
information disclosure statement should not preclude a remand from 
being considered a decision in the review reversing an adverse 
determination of patentability for patent term extension or adjustment 
purposes. One comment suggested that a remand should be treated as a 
decision by the BPAI reversing an adverse determination of 
patentability any time the examiner sua sponte withdraws all of the 
rejections against any one claim. Finally, one comment suggested that 
if the Office drops any issue raised upon appeal after the remand, the 
examiner's dropping of an issue raised upon appeal should be considered 
a decision in the review reversing an adverse determination of 
patentability.
    Response: The suggestions are adopted in part as follows. If an 
application is remanded by a panel of the BPAI and the remand is the 
last action of a BPAI panel prior to the mailing of a notice of 
allowance under 35 U.S.C. 151 in the application, the Office will 
consider that remand to be a decision in the review reversing an 
adverse determination of patentability. Therefore, if the examiner 
allows the application (patent term extension or adjustment is not 
relevant if the application is not ultimately allowed) without 
returning the application to the BPAI for decision (and thus the BPAI 
panel remand is the last action by a BPAI panel in the application), 
the Office will consider that remand to be a decision in the review 
reversing an adverse determination of patentability. A panel remand, 
however, shall not be considered a decision in the review reversing an 
adverse determination of patentability if there is filed a request for 
continued examination under 35 U.S.C. 132(b) (Sec.  1.114) that was not 
first preceded by the mailing, after such remand, of at least one of an 
action under 35 U.S.C. 132 or a notice of allowance under 35 U.S.C. 
151.
    Comment 5: One comment also suggested that the Office should permit 
applicant to petition under Sec.  1.705 for a case-by-case 
determination of whether the BPAI remand should be considered a 
decision in the review reversing an adverse determination of 
patentability for patent term extension or adjustment purposes.
    Response: The statutory scheme of 35 U.S.C. 154(b) provides that 
patent term adjustment and reductions to patent term adjustment are 
determined by objective criteria rather than on the basis of ad hoc 
determinations. That is, 35 U.S.C. 154(b)(1) specifies certain 
objective conditions under which (subject to certain conditions and 
limitations) an applicant is entitled to patent term adjustment, and 35 
U.S.C. 154(b)(2)(C) requires the Office to specify (by regulations) the 
conditions under which there will be a reduction of patent term 
adjustment under 35 U.S.C. 154(b)(1). Thus, it is more in line with the 
statutory scheme set forth in 35 U.S.C. 154(b) for the Office to 
specify objective criteria under which a BPAI panel remand will be 
considered a decision in the review reversing an adverse determination 
of patentability for patent term extension or adjustment purposes, than 
it would be to leave this to case-by-case determinations.
    In addition, as discussed in the final rule to implement the patent 
term adjustment provisions of the AIPA: ``the Office must make its 
patent term adjustment determinations by a computer program that uses 
the information recorded in the Office's automated patent application 
information system (the Patent Application Location and Monitoring 
system or PALM system). Thus, the Office must determine whether the 
Board of Patent Appeals and Interferences (or court) decision was of a 
nature such that `the patent was issued under a decision in the review 
reversing an adverse determination of patentability' under 35 U.S.C. 
154(b)(1)(C)(iii) from information concerning the decision susceptible 
of being recorded in the PALM system (rather than by a case-by-case 
review of each decision).'' See Changes To Implement Patent Term 
Adjustment Under Twenty-Year Patent Term, 65 FR at 56370, 1239 Off. 
Gaz. Pat. Office at 17 (quoting 35 U.S.C. 154(b)(1)(C)(iii)).
    Comment 6: One comment suggests that the rule be automatically 
retroactively applied or alternately set up a petition procedure where 
patentees would be allowed to petition for recalculation of the patent 
term extension or adjustment determination based upon the amended rule.
    Response: The Office cannot ``automatically'' apply revised 
Sec. Sec.  1.701(a)(3) and 1.702(e) retroactively in applications in 
which the notice of allowance was mailed before May 24, 2004. However, 
a patentee who believes that the patent term extension or adjustment 
indicated on his or her patent would have been calculated differently 
under Sec.  1.701(a)(3) or Sec.  1.702(e) as amended in this final rule 
may file a request for reconsideration of the patent term extension or 
adjustment indicated on the patent. Any such request for 
reconsideration must be filed no later than July 21, 2004.
    For applications in which the notice of allowance is mailed on or 
after May 24, 2004, any applicant who believes that the URAA patent 
term extension (Sec.  1.701) or AIPA patent term adjustment (Sec. Sec.  
1.702 through 1.705) indicated in the notice of allowance was not 
calculated correctly in view of the changes to Sec.  1.701(a)(3) or 
Sec.  1.702(e) in this final rule must file a timely petition under 
Sec.  1.181 or timely request for reconsideration under Sec.  1.705(b) 
(respectively) to have the patent term extension or adjustment 
determination corrected. Any applicant who believes that the URAA 
patent term extension (Sec.  1.701) or AIPA patent term adjustment 
(Sec. Sec.  1.702 through 1.705) indicated in the notice of allowance 
was not calculated correctly on any basis other than the changes to 
Sec.  1.701(a)(3) or Sec.  1.702(e) in this final rule must file a

[[Page 21709]]

timely petition under Sec.  1.181 or timely request for reconsideration 
under Sec.  1.705(b) (respectively) to have the patent term extension 
or adjustment determination corrected.
    Comment 7: One comment suggests that the period of adjustment for 
administrative delay should end on the date of the mailing of the 
notice of allowance, not on the mailing date of the remand.
    Response: The suggestion is not adopted. If an application is 
allowed after a panel remand by the BPAI, the period of appellate 
review ended with the decision (remand) by the BPAI.
    Comment 8: Several comments indicated that events such as the 
filing of a request for refund or the filing of a status letter are 
caused by an Office error or delay, and should not result in a 
reduction of patent term adjustment under Sec.  1.704(c)(10).
    Response: The patent term adjustment provisions of 35 U.S.C. 154(b) 
provide 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). Section 1.704(c)(10) 
provides that circumstances that constitute a failure of the applicant 
to engage in reasonable efforts to conclude processing or examination 
of an application also include ``[s]ubmission of an amendment under 
Sec.  1.312 or other paper after a notice of allowance has been given 
or mailed, in which case the period of adjustment set forth in Sec.  
1.703 shall be reduced by the lesser of: (i) [t]he number of days, if 
any, beginning on the date the amendment under Sec.  1.312 or other 
paper was filed and ending on the mailing date of the Office action or 
notice in response to the amendment under Sec.  1.312 or such other 
paper; or (ii) [f]our months.'' The Office did not propose any change 
to the provisions of Sec.  1.704(c). The 21st Century Strategic Plan 
notice of proposed rule making, however, did include a previously 
published clarification of the provisions of Sec.  1.704(c)(10). See 
Clarification of 37 CFR 1.704(c)(10)--Reduction of Patent Term 
Adjustment for Certain Types of Papers Filed After a Notice of 
Allowance Has Been Mailed, 1247 Off. Gaz. Pat. Office at 111-12.
    The filing of certain papers, such as a request for refund or a 
status letter, after a notice of allowance has been mailed causes 
substantial interference with the patent issue process. See id. 
Therefore, pursuant to the authority to 35 U.S.C. 154(b)(2)(C)(iii), 
the Office has prescribed a regulation (Sec.  1.704(c)(1)) establishing 
the filing of such papers after a notice of allowance has been mailed 
as a failure of an applicant to engage in reasonable efforts to 
conclude processing or examination of an application.
    Section 1.26(b) provides a lengthy (two-year) period for filing any 
request for refund. Thus, applicants may avoid a reduction of any 
patent term adjustment by not filing a request for refund during the 
period between the mailing of a notice of allowance and the date the 
patent is issued. Applicants who choose to file a request for refund at 
a time when the filing of such a paper causes interference with the 
patent issue process must accept the negative impact on patent term 
adjustment that will result from such a course of action.
    As discussed above, the PAIR system provides public access to PALM 
for patents and applications that have been published which can be 
accessed over the Internet (at http://pair.uspto.gov), and has a 
private side (http://pair-direct.uspto.gov) which may be used by an 
applicant to access confidential information about his or her pending 
application. See id. Thus, applicants who choose to file status letters 
rather than check the status of their applications via the PAIR system 
must accept the negative impact on patent term adjustment that will 
result from such a course of action.
    Comment 9: Several comments indicated that the thirty-day period 
provided in Sec.  1.704(d) was too short and should be changed to three 
months for consistency with Sec.  1.97(e).
    Response: Section 1.704(d) was adopted to permit applicants to 
submit information cited in a communication from a foreign patent 
office in a counterpart application to the Office without a reduction 
in patent term adjustment if an information disclosure statement is 
promptly (within thirty days of receipt of the communication) submitted 
to the Office.
    See Changes to Implement Patent Term Adjustment Under Twenty-Year 
Patent Term, 65 FR at 56373, 56385, 1239 Off. Gaz. Pat. Office at 20, 
30-31. The Office did not propose to change the thirty-day period 
provided in Sec.  1.704(d).
    Section 1.704(d) does not provide that an information disclosure 
statement must be submitted within its thirty-day period to avoid a 
reduction of patent term adjustment (or to be considered by the 
Office), but rather provides a ``safe-harbor'' against reductions to 
patent term adjustment under Sec. Sec.  1.704(c)(6), (c)(8), (c)(9), or 
(c)(10) that may result from the filing of an information disclosure 
statement. The filing of an information disclosure statement during any 
of the periods set forth in Sec. Sec.  1.704(c)(6), (c)(8), (c)(9), or 
(c)(10) will interfere with the patent examination or printing process. 
Therefore, the Office must limit the time period in Sec.  1.704(d) to 
thirty days to avoid substantial interference with the Office's ability 
to meet the time frames specified in 35 U.S.C. 154(b)(1). See Changes 
to Implement Patent Term Adjustment Under Twenty-Year Patent Term, 65 
FR at 56385, 1239 Off. Gaz. Pat. Office at 30.

Rule Making Considerations

Administrative Procedure Act

    The change to Sec.  1.703 in this final rule simply amends its 
provisions for consistency with 35 U.S.C. 154(b)(2)(A), and the change 
to Sec.  1.705 concerns only the procedures for requesting 
reconsideration of the patent term adjustment determination printed on 
the patent. Therefore, these rule changes involve interpretive rules, 
or rules of agency practice and procedure under 5 U.S.C. 553(b)(A), and 
prior notice and an opportunity for public comment were not required 
pursuant to 5 U.S.C. 553(b)(A) (or any other law). See Bachow 
Communications Inc. v. FCC, 237 F.3d 683, 690 (D.C. 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).

Regulatory Flexibility Act

    As discussed previously, the changes to Sec. Sec.  1.703 and 1.705 
involve interpretive rules, or rules of agency practice and procedure 
under 5 U.S.C. 553(b)(A), for which prior notice and an opportunity for 
public comment were not required pursuant to 5 U.S.C. 553(b)(A) (or any 
other law).
    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 changes in this 
final rule will not have a significant economic impact on a substantial 
number of small entities (Regulatory Flexibility Act, 5 U.S.C. 605(b)). 
The provisions of the Regulatory Flexibility Act relating to the 
preparation of a flexibility analysis are not applicable to this rule 
making because the changes in this final rule will not have a 
significant economic impact on a substantial number of small entities.
    The primary change in this final rule (Sec. Sec.  1.701 and 1.702) 
is to set forth the circumstances under which the Office

[[Page 21710]]

will consider a remand by the BPAI to be a decision in the review 
reversing an adverse determination of patentability for purposes of 
patent term extension and patent term adjustment. Of the 3,843 
decisions in ex parte appeals in fiscal year 2003, 454 of these 
decisions remanded the application without affirming or reversing any 
of the rejections on appeal. Since approximately 25% of the patents 
granted in fiscal year 2003 were to small entities, the Office 
estimates that approximately 114 small entity applicants may be 
affected by the change to Sec. Sec.  1.701 and 1.702 in this final 
rule. Since the Office received over 350,000 nonprovisional 
applications in fiscal year 2003, the change to Sec. Sec.  1.701 and 
1.702 in this final rule would impact relatively few (fewer than 0.1% 
of) patent applicants.
    The change to Sec.  1.704 merely clarifies that the thirty-day time 
period in Sec.  1.704(d) runs from the first citation of the 
information by a foreign patent office, and that a subsequent citation 
of the same information by another foreign patent office would not 
start a new thirty-day period. Thus, the change to Sec.  1.704 in this 
final rule will not have a significant economic impact on any entity.
    In any event, the changes in this final rule merely concern the 
Office's manner of calculating patent term extension or patent term 
adjustment determination in certain situations, and revise the time 
period (from thirty days to two months) for requesting reconsideration 
of the patent term adjustment determination printed on the patent. The 
changes in this final rule would not impose any additional fees or 
requirements on any patent applicant. The Office published a notice of 
proposed rule making and certified that an initial Regulatory Act 
Analysis was not required. No comment on the changes being adopted in 
this final rule made reference to any impact of the changes on small 
entities.

Executive Order 13132

    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).

Executive Order 12866

    This rule making has been determined to be not significant for 
purposes of Executive Order 12866 (Sept. 30, 1993).

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 previously approved by OMB under OMB control number 0651-0020. The 
United States Patent and Trademark Office is not resubmitting an 
information collection package to OMB for its review and approval 
because the changes in this final rule do not affect the information 
collection requirements associated with the information collection 
under OMB control number 0651-0020.
    The title, description and respondent description of this 
information collection 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. The primary change in this 
final rule is to set forth the circumstances under which the Office 
will consider a remand by the BPAI to be a decision in the review 
reversing an adverse determination of patentability for purposes of 
patent term extension and patent term adjustment.
    OMB Number: 0651-0020.
    Title: Patent Term Extension.
    Form Numbers: None.
    Type of Review: Approved through October of 2004.
    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: 26,859.
    Estimated Time Per Response: Between 1 and 25 hours.
    Estimated Total Annual Burden Hours: 30,905 hours.
    Needs and Uses: The information supplied to the United States 
Patent and Trademark Office by an applicant requesting reconsideration 
of a patent term adjustment determination under 35 U.S.C. 154(b) (Sec.  
1.702 et seq.) is used by the United States Patent and Trademark Office 
to determine whether its determination of patent term adjustment under 
35 U.S.C. 154(b) is correct, and whether the applicant is entitled to 
reinstatement of reduced patent term adjustment. The information 
supplied to the United States Patent and Trademark Office by an 
applicant seeking a patent term extension under 35 U.S.C. 156 (Sec.  
1.710 et seq.) is used by the United States Patent and Trademark 
Office, the Department of Health and Human Services, and the Department 
of Agriculture to determine the eligibility of a patent for extension 
and to determine the period of any such extension. The applicant can 
apply for patent term and interim extensions, petition the Office to 
review final eligibility decisions, withdraw patent term applications, 
and declare his or her eligibility to apply for a patent term 
extension.
    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 Robert J. Spar, Director, Office of Patent Legal 
Administration, Commissioner for Patents, P.O. Box 1450, Alexandria, VA 
22313-1450, or to the Office of Information and Regulatory Affairs, 
Office of Management and Budget, New Executive Office Building, Room 
10235, 725 17th Street, NW., Washington, DC 20503, Attention: Desk 
Officer for the United States Patent and Trademark Office.
    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 record keeping 
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 1.701 is amended by revising paragraph (a)(3) to read as 
follows:


Sec.  1.701  Extension of patent term due to examination delay under 
the Uruguay Round Agreements Act (original applications, other than 
designs, filed on or after June 8, 1995, and before May 29, 2000).

    (a) * * *

[[Page 21711]]

    (3) Appellate review by the Board of Patent Appeals and 
Interferences or by a Federal court under 35 U.S.C. 141 or 145, if the 
patent was issued pursuant to a decision in the review reversing an 
adverse determination of patentability and if the patent is not subject 
to a terminal disclaimer due to the issuance of another patent claiming 
subject matter that is not patentably distinct from that under 
appellate review. If an application is remanded by a panel of the Board 
of Patent Appeals and Interferences and the remand is the last action 
by a panel of the Board of Patent Appeals and Interferences prior to 
the mailing of a notice of allowance under 35 U.S.C. 151 in the 
application, the remand shall be considered a decision in the review 
reversing an adverse determination of patentability as that phrase is 
used in 35 U.S.C. 154(b)(2) as amended by section 532(a) of the Uruguay 
Round Agreements Act, Public Law 103-465, 108 Stat. 4809, 4983-85 
(1994), and a final decision in favor of the applicant under paragraph 
(c)(3) of this section. A remand by a panel of the Board of Patent 
Appeals and Interferences shall not be considered a decision in the 
review reversing an adverse determination of patentability as provided 
in this paragraph if there is filed a request for continued examination 
under 35 U.S.C. 132(b) that was not first preceded by the mailing, 
after such remand, of at least one of an action under 35 U.S.C. 132 or 
a notice of allowance under 35 U.S.C. 151.
* * * * *

0
3. Section 1.702 is amended by revising paragraph (e) to read as 
follows:


Sec.  1.702  Grounds for adjustment of patent term due to examination 
delay under the Patent Term Guarantee Act of 1999 (original 
applications, other than designs, filed on or after May 29, 2000).

* * * * *
    (e) Delays caused by successful appellate review. Subject to the 
provisions of 35 U.S.C. 154(b) and this subpart, the term of an 
original patent shall be adjusted if the issuance of the patent was 
delayed due to review by the Board of Patent Appeals and Interferences 
under 35 U.S.C. 134 or by a Federal court under 35 U.S.C. 141 or 145, 
if the patent was issued under a decision in the review reversing an 
adverse determination of patentability. If an application is remanded 
by a panel of the Board of Patent Appeals and Interferences and the 
remand is the last action by a panel of the Board of Patent Appeals and 
Interferences prior to the mailing of a notice of allowance under 35 
U.S.C. 151 in the application, the remand shall be considered a 
decision by the Board of Patent Appeals and Interferences as that 
phrase is used in 35 U.S.C. 154(b)(1)(A)(iii), a decision in the review 
reversing an adverse determination of patentability as that phrase is 
used in 35 U.S.C. 154(b)(1)(C)(iii), and a final decision in favor of 
the applicant under Sec.  1.703(e). A remand by a panel of the Board of 
Patent Appeals and Interferences shall not be considered a decision in 
the review reversing an adverse determination of patentability as 
provided in this paragraph if there is filed a request for continued 
examination under 35 U.S.C. 132(b) that was not first preceded by the 
mailing, after such remand, of at least one of an action under 35 
U.S.C. 132 or a notice of allowance under 35 U.S.C. 151.
* * * * *

0
4. Section 1.703 is amended by revising paragraph (f) to read as 
follows.


Sec.  1.703  Period of adjustment of patent term due to examination 
delay.

* * * * *
    (f) The adjustment will run from the expiration date of the patent 
as set forth in 35 U.S.C. 154(a)(2). To the extent that periods of 
delay attributable to the grounds specified in Sec.  1.702 overlap, the 
period of adjustment granted under this section shall not exceed the 
actual number of days the issuance of the patent was delayed. The term 
of a patent entitled to adjustment under Sec.  1.702 and this section 
shall be adjusted for the sum of the periods calculated under 
paragraphs (a) through (e) of this section, to the extent that such 
periods are not overlapping, less the sum of the periods calculated 
under Sec.  1.704. The date indicated on any certificate of mailing or 
transmission under Sec.  1.8 shall not be taken into account in this 
calculation.
* * * * *

0
5. Section 1.704 is amended by revising paragraph (d) to read as 
follows.


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

* * * * *
    (d) A paper containing only an information disclosure statement in 
compliance with Sec. Sec.  1.97 and 1.98 will not be considered a 
failure to engage in reasonable efforts to conclude prosecution 
(processing or examination) of the application under paragraphs (c)(6), 
(c)(8), (c)(9), or (c)(10) of this section if it is accompanied by a 
statement that each item of information contained in the information 
disclosure statement was first cited in any communication from a 
foreign patent office in a counterpart application and that this 
communication was not received by any individual designated in Sec.  
1.56(c) more than thirty days prior to the filing of the information 
disclosure statement. This thirty-day period is not extendable.
* * * * *

0
6. Section 1.705 is amended by revising paragraph (d) to read as 
follows:


Sec.  1.705  Patent term adjustment determination.

* * * * *
    (d) If there is a revision to the patent term adjustment indicated 
in the notice of allowance, the patent will indicate the revised patent 
term adjustment. If the patent indicates or should have indicated a 
revised patent term adjustment, any request for reconsideration of the 
patent term adjustment indicated in the patent must be filed within two 
months of the date the patent issued and must comply with the 
requirements of paragraphs (b)(1) and (b)(2) of this section. Any 
request for reconsideration under this section that raises issues that 
were raised, or could have been raised, in an application for patent 
term adjustment under paragraph (b) of this section shall be dismissed 
as untimely as to those issues.
* * * * *

    Dated: April 16, 2004.
Jon W. Dudas,
Acting Under Secretary of Commerce for Intellectual Property and Acting 
Director of the United States Patent and Trademark Office.
[FR Doc. 04-9144 Filed 4-21-04; 8:45 am]
BILLING CODE 3510-16-P