[Federal Register Volume 65, Number 63 (Friday, March 31, 2000)]
[Proposed Rules]
[Pages 17215-17229]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-7938]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No.: 000308066-0066-01]
RIN 0651-AB06


Changes to Implement Patent Term Adjustment Under Twenty-Year 
Patent Term

AGENCY: Patent and Trademark Office, Commerce.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The United States Patent and Trademark Office (Office) is 
proposing changes to the rules of practice in patent cases to implement 
certain provisions of section 4402 of the ``American Inventors 
Protection Act of 1999.'' These provisions of the ``American Inventors 
Protection Act of 1999'' provide patent term adjustment to compensate 
patentees for certain delays in the application examination process.

DATES: Comment Deadline Date: To be ensured of consideration, written 
comments must be received on or before May 30, 2000. No public hearing 
will be held.

ADDRESSES: Comments should be sent by electronic mail message over the 
Internet addressed to: [email protected]. Comments may also 
be submitted by mail addressed to: Box Comments--Patents, Commissioner 
for Patents, Washington, D.C. 20231, or by facsimile to (703) 872-9411 
or (703) 308-6916, marked to the attention of Karin L. Tyson. Although 
comments may be submitted by mail or facsimile, the Office prefers to 
receive comments via the Internet. If comments are submitted by mail, 
the Office would prefer that the comments be submitted on a DOS 
formatted 3\1/2\ inch disk accompanied by a paper copy.
    The comments will be available for public inspection at the Special 
Program Law Office, Office of the Deputy Assistant Commissioner for 
Patent Policy and Projects, located at Room 3-C23 of Crystal Plaza 4, 
2201 South Clark Place, Arlington, Virginia, and will be available 
through anonymous file transfer protocol (ftp) via the Internet 
(address: http://www.uspto.gov). Since comments will be made available 
for public inspection, information that is not desired to be made 
public, such as an address or phone number, should not be included in 
the comments.

FOR FURTHER INFORMATION CONTACT: Karin L. Tyson, Robert W. Bahr, or 
Robert A. Clarke by telephone at (703) 305-1383, or by mail addressed 
to: Box Comments--Patents, Commissioner for Patents, Washington, D.C. 
20231, or by facsimile to (703) 872-9411 or (703) 308-6916, marked to 
the attention of Karin L. Tyson.

SUPPLEMENTARY INFORMATION: The ``American Inventors Protection Act of 
1999'' (Title IV of the ``Intellectual Property and Communications 
Omnibus Reform Act of 1999'' (S. 1948) as introduced in the 106th 
Congress on November 17, 1999) was incorporated and enacted into law on 
November 29, 1999, by Sec. 1000(a)(9), Division B, of Public Law 106-
113, 113 Stat. 1501 (1999). The ``American Inventors Protection Act of 
1999'' contains a number of changes to title 35, United States Code. 
This notice proposes changes to the rules of practice to implement the 
provisions of Secs. 4401 and 4402 of the ``American Inventors 
Protection Act of 1999.'' These provisions are effective on the date 
that is six months after the date of enactment of the ``American 
Inventors Protection Act of 1999'' (May 29, 2000) and apply to 
applications, other than for a design patent, filed on or after the 
date that is six months after the date of enactment of the ``American 
Inventors Protection Act of 1999'' (May 29, 2000).
    Section 532 of the Uruguay Round Agreements Act (Public Law 103-
465, 108 Stat. 4809 (1994)) amended 35 U.S.C. 154 to provide that the 
term of patent protection begins on the date of patent grant and ends 
on the date 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.
    Section 4402 of the ``American Inventors Protection Act of 1999'' 
amends 35 U.S.C. 154(b)(1) to provide

[[Page 17216]]

day-by-day patent term adjustment if the Office fails, within specified 
time periods, to: (1) initially act on the application; (2) respond to 
a reply or appeal to the Board of Patent Appeals and Interferences by 
the applicant; (3) act on an application containing allowed claims 
after a decision by the Board of Patent Appeals and Interferences or a 
Federal court; or (4) issue the application after the issue fee is paid 
in reply to a notice of allowance and all outstanding requirements are 
satisfied (35 U.S.C. 154(b)(1)(A)). Section 4402 of the ``American 
Inventors Protection Act of 1999'' also amends 35 U.S.C. 154(b)(1) to 
provide day-by-day patent term adjustment if, subject to a number of 
limitations, the Office fails to issue a patent within three years of 
the actual filing date of the application (35 U.S.C. 154(b)(1)(B)). 
Finally, Sec. 4402 of the ``American Inventors Protection Act of 1999'' 
also amends 35 U.S.C. 154(b)(1) to provide day-by-day patent term 
adjustment for delays due to interference proceedings under 35 U.S.C. 
135(a), imposition of a secrecy order under 35 U.S.C. 181, or 
successful appellate review by the Board of Patent Appeals and 
Interferences or a Federal court (35 U.S.C. 154(b)(1)(C)).
    Section 4402 of the ``American Inventors Protection Act of 1999'' 
amends 35 U.S.C. 154(b)(2) to place limitations on the period of patent 
term adjustment granted under 35 U.S.C. 154(b)(1). First: to the extent 
that the periods of delay attributed to the grounds specified in 35 
U.S.C. 154(b)(1) overlap, the period of adjustment shall not exceed the 
actual number of days the issuance of the patent was delayed. Second: 
no patent, the term of which has been disclaimed beyond a specified 
date, may be adjusted under 35 U.S.C. 154(b) beyond the expiration date 
specified in the disclaimer. Third: the period of patent term 
adjustment under 35 U.S.C. 154(b)(1) shall be reduced by a period equal 
to the period of time during which the applicant failed to engage in 
reasonable efforts to conclude prosecution (or processing or 
examination) of the application. Section 4402 of the ``American 
Inventors Protection Act of 1999,'' however, does not contain any limit 
(e.g., of five or ten years) on the total extension or adjustment that 
may be granted under 35 U.S.C. 154(b).
    An applicant is deemed to have failed to engage in reasonable 
efforts to conclude prosecution of the application with respect to any 
patent term adjustment under 35 U.S.C. 154(b)(1)(B) (failure to issue a 
patent within three years of the actual filing date of the application) 
for the cumulative total of any periods of time in excess of three 
months that are taken to reply to a notice of any rejection, objection, 
argument, or other request, measuring the three-month period from the 
date the notice was mailed or given. In addition, 35 U.S.C. 154(b)(2) 
directs the Office to prescribe regulations establishing the 
circumstances that constitute a failure of the applicant to engage in 
reasonable efforts to conclude processing or examination of the 
application.
    Section 4402 of the ``American Inventors Protection Act of 1999'' 
also amends 35 U.S.C. 154(b)(3) to establish procedures for patent term 
adjustment determinations. 35 U.S.C. 154(b)(3) directs the Office to 
prescribe regulations establishing procedures for the application for 
and determination of patent term adjustment under 35 U.S.C. 154(b). 35 
U.S.C. 154(b)(3), however, requires the Office to: (1) make a patent 
term adjustment determination and transmit a notice of that 
determination with the notice of allowance; and (2) provide the 
applicant with one opportunity to request reconsideration of that 
patent term adjustment determination. 35 U.S.C. 154(b)(3) also provides 
that the Office shall reinstate all or part of the cumulative period of 
time of an adjustment reduced under 35 U.S.C. 154(b)(2)(C) (for failure 
to reply to a notice of any rejection, objection, argument, or other 
request within three months of the date the notice was mailed or given) 
if, prior to issuance of the patent, the applicant makes a showing 
that, in spite of all due care, the applicant was unable to reply 
within the three-month period, except that the Office may not reinstate 
more than three additional months for each reply beyond the original 
three-month period. Section 4402 of the ``American Inventors Protection 
Act of 1999'' also amends 35 U.S.C. 154(b)(3) to provide that the 
Office shall proceed to grant the patent after completing its patent 
term adjustment determination, and amends 35 U.S.C. 154(b)(4) to 
provide for judicial review in the event that the applicant is 
dissatisfied with that patent term adjustment determination.
    Section 4405(a) of the ``American Inventors Protection Act of 
1999'' provides that Sec. 4402 shall take effect on the date that is 
six months after the date of enactment of the ``American Inventors 
Protection Act of 1999'' (May 29, 2000) and shall apply to any 
application (other than a reissue or design) filed on or after the date 
that is six months after the date of enactment of the ``American 
Inventors Protection Act of 1999'' (May 29, 2000). Therefore, patents 
(other than reissue or design) issued on applications filed on or after 
June 8, 1995, but before May 29, 2000, are subject to the patent term 
extension provisions of 35 U.S.C. 154(b) as amended by Sec. 532(a)(1) 
of Public Law 103-465 and Sec. 1.701, whereas patents (other than 
reissue or design) issued on applications filed on or after May 29, 
2000, are subject to the patent term adjustment provisions of 35 U.S.C. 
154(b) as amended by Sec. 4402 of the ``American Inventors Protection 
Act of 1999'' (as it is proposed to be implemented in Secs. 1.702 
through 1.705).
    The filing date of a continued prosecution application (CPA) under 
Sec. 1.53(d) is the date that the request for CPA is filed 
(Sec. 1.53(d)(2)), even though the Office uses the filing date of the 
prior application for identification purposes. Therefore, the patent 
term adjustment provisions of 35 U.S.C. 154(b) as amended by Sec. 4402 
of the ``American Inventors Protection Act of 1999'' apply to any CPA 
filed on or after May 29, 2000, regardless of the filing date of the 
prior application of the CPA. While an applicant may file a continuing 
application under Sec. 1.53(b) on or after May 29, 2000, for the 
application to be subject to the patent term adjustment provisions of 
35 U.S.C. 154(b) as amended by Sec. 4402 of the ``American Inventors 
Protection Act of 1999,'' an applicant need only file a CPA under 
Sec. 1.53(d) on or after May 29, 2000, for the application to be 
subject to the patent term adjustment provisions of 35 U.S.C. 154(b) as 
amended by Sec. 4402 of the ``American Inventors Protection Act of 
1999.'' The filing of a CPA on or after May 29, 2000, does not, 
however, entitle an applicant to receive term adjustment for Office 
delays before May 29, 2000.
    The six-month lead time provided in Sec. 4405(a) for implementing 
the patent term adjustment provisions of Sec. 4402 of the ``American 
Inventors Protection Act of 1999'' is not sufficient to conduct a 
notice and comment rulemaking (giving a 60-day comment period) and 
adopt final rules by the effective date (May 29, 2000) of the patent 
term adjustment provisions of Sec. 4402 of the ``American Inventors 
Protection Act of 1999.'' Nevertheless, the Office does not anticipate 
that any patent entitled to patent term adjustment based upon the 
provisions of Sec. 4402 of the ``American Inventors Protection Act of 
1999'' will issue until December of 2000, at the earliest. This notice 
of proposed rulemaking, however, places applicants on notice as to the 
actions or inactions that are considered by the Office (and may be 
adopted in the final rules) as circumstances constituting a failure to

[[Page 17217]]

engage in reasonable efforts to conclude prosecution (processing or 
examination) of the application, and which will result in a reduction 
of any patent term adjustment.

Discussion of Specific Rules

    Section 1.18(e) is proposed to be added to provide a $200.00 fee 
for filing an application for patent term adjustment under Sec. 1.705. 
Section 1.18(f) is proposed to be added to provide a $450.00 fee for 
filing a request for reinstatement of all or part of the term reduced 
pursuant to Sec. 1.704(b)(1) in an application for patent term 
adjustment under Sec. 1.705. Section 1.18(d) is proposed to be added in 
a rulemaking to implement the eighteen-month publication provisions of 
the ``American Inventors Protection Act of 1999.'' The fees in proposed 
Sec. 1.18(e) and (f) are set to recover the estimated average cost to 
the Office for processing and evaluating an application for patent term 
adjustment under Sec. 1.705 ($200.00), and for processing and 
evaluating a request under 35 U.S.C. 154(b)(3)(C) for reinstatement of 
term reduced under 35 U.S.C. 154(b)(2)(C) ($450.00), respectively. See 
35 U.S.C. 41(d). In view of these proposed additions to Sec. 1.18, the 
heading of Sec. 1.18 is also proposed to be amended to refer to patent 
``post-allowance (including issue) fees'( instead of only patent 
``issue fees'').
    Subpart F of 37 CFR Part 1 is proposed to be amended to include a 
first undesignated center heading to read ``ADJUSTMENT OF PATENT TERM 
DUE TO EXAMINATION DELAY'' followed by an amended Sec. 1.701 and newly 
added Secs. 1.702 through 1.705 concerning patent term adjustment under 
35 U.S.C. 154(b), and a second undesignated center heading to read 
``EXTENSION OF PATENT TERM DUE TO REGULATORY REVIEW'' followed by 
current Sec. 1.710 et seq. concerning patent term extension under 35 
U.S.C. 156.
    Section 1.701 is proposed to be amended by revising its heading to 
indicate that its provisions concern the term provisions of the Uruguay 
Round Agreements Act (Public Law 103-465), and to add a paragraph (e) 
to specify that the provisions of Sec. 1.701 apply only to original 
patents issued on applications filed on or after June 8, 1995, and 
before May 29, 2000. As discussed above, the provisions of 35 U.S.C. 
154(b) as amended by Sec. 532(a)(1) of Public Law 103-465 and current 
Sec. 1.701 apply to applications (other than for a reissue or design 
patent) filed on or after June 8, 1995, but before May 29, 2000, and 
the provisions of Sec. 4402 of the ``American Inventors Protection Act 
of 1999'' and proposed Secs. 1.702 through 1.705 apply to applications 
(other than for a reissue or design patent) filed on or after May 29, 
2000.
    Section 1.702 is proposed to be added to set forth the bases for 
patent term adjustment under 35 U.S.C. 154(b)(1). Section 1.702(a) as 
proposed indicates that a patent is entitled to patent term adjustment 
if the Office fails to perform certain acts of examination within 
specified time frames (35 U.S.C. 154(b)(1)(A)). Section 1.702(b) as 
proposed indicates that a patent is entitled to patent term adjustment 
if, subject to a number of limitations, the Office fails to issue a 
patent within three years of the actual filing date of the application 
(35 U.S.C. 154(b)(1)(B)). Section 1.702(c) as proposed indicates that a 
patent is entitled to patent term adjustment if the issuance of the 
patent was delayed by an interference proceeding (35 U.S.C. 
154(b)(1)(C)(i)). Section 1.702(d) as proposed indicates that a patent 
is entitled to patent term adjustment if the issuance of the patent was 
delayed by the application being placed under a secrecy order under 35 
U.S.C. 181 (35 U.S.C. 154(b)(1)(C)(ii)). Section 1.702(e) as proposed 
indicates that a patent is entitled to patent term adjustment if the 
issuance of the patent was delayed by successful appellate review under 
35 U.S.C. 134, 141, or 145 (35 U.S.C. 154(b)(1)(C)(iii)). Section 
1.702(f) as proposed provides that the provisions of Secs. 1.702 
through 1.705 apply only to original applications, except applications 
for a design patent, filed on or after May 29, 2000, and patents issued 
on such applications.
    Section 1.703 as proposed specifies the period of adjustment if a 
patent is entitled to patent term adjustment under 35 U.S.C. 154(b)(1) 
and Sec. 1.702.
    Section 1.703(a) as proposed indicates that the period of 
adjustment under Sec. 1.702(a) is the sum of the following periods (to 
the extent that such periods are not overlapping): (1) The number of 
days, if any, in the period beginning on the date fourteen months after 
the date on which the application was filed under 35 U.S.C. 111(a) or 
fulfilled the requirements of 35 U.S.C. 371 and ending on the mailing 
date of either an action under 35 U.S.C. 132, or a notice of allowance 
under 35 U.S.C. 151, whichever occurs first (a written restriction 
requirement, a written election of species requirement, and an action 
under Ex parte Quayle, 1935 Comm'r Dec. 11 (1935) are each an action 
under 35 U.S.C. 132); (2) the number of days, if any, in the period 
beginning on the date four months after the date a reply under 
Sec. 1.111 was filed and ending on the mailing date of an action under 
35 U.S.C. 132, or a notice of allowance under 35 U.S.C. 151, whichever 
occurs first; (3) the number of days, if any, in the period beginning 
on the date four months after the date a reply in compliance with 
Sec. 1.113 (i.e., only an after final reply that cancels all of the 
rejected claims and removes all outstanding objections and requirements 
or otherwise places the application in condition for allowance) was 
filed and ending on the date of mailing of an action under 35 U.S.C. 
132, or a notice of allowance under 35 U.S.C. 151, whichever occurs 
first; (4) the number of days, if any, in the period beginning on the 
date four months after the date a notice of appeal to the Board of 
Patent Appeals and Interferences under 35 U.S.C. 134 and Sec. 1.191 was 
filed and ending on the mailing date of an examiner's answer under 
Sec. 1.193, an action under 35 U.S.C. 132, or a notice of allowance 
under 35 U.S.C. 151, whichever occurs first; (5) the number of days, if 
any, in the period beginning on the date four months after the date of 
a final decision by the Board of Patent Appeals and Interferences or by 
a Federal court in an appeal under 35 U.S.C. 141 or a civil action 
under 35 U.S.C. 145 or 146 in an application containing allowable 
claims and ending on the mailing date of either an action under 35 
U.S.C. 132, or a notice of allowance under 35 U.S.C. 151, whichever 
occurs first; and (6) the number of days, if any, in the period 
beginning on the date four months after the date the issue fee was paid 
and all outstanding requirements were satisfied (i.e., the date the 
issue fee was paid or the date all outstanding requirements were 
satisfied, whichever is later) and ending on the date a patent was 
issued.
    Section 1.703(b) as proposed indicates that the period of 
adjustment under Sec. 1.702(b) is the number of days, if any, in the 
period beginning on the date three years after the actual filing date 
of the application and ending on the date a patent was issued. Section 
1.703(b) as proposed also sets forth the limitations on patent term 
adjustment specified in 35 U.S.C. 154(b)(1)(B)(i) and (ii). Section 
1.703(b) as proposed specifically provides that the period of 
adjustment of the term of a patent under Sec. 1.703(b) shall not 
include the period equal to the sum of the following periods: (1) The 
period of pendency consumed by continued examination of the application 
under 35 U.S.C. 132(b) (35 U.S.C. 154(b)(1)(B)(i)); (2) the period of 
pendency consumed by interference proceedings (35 U.S.C. 
154(b)(1)(B)(ii)); (3) the period of pendency consumed by

[[Page 17218]]

imposition of a secrecy order (35 U.S.C. 154(b)(1)(B)(ii)); and (4) the 
period of pendency consumed by appellate review under 35 U.S.C. 134, 
141, 145, whether successful or unsuccessful (35 U.S.C. 
154(b)(1)(B)(ii)). The provisions of 35 U.S.C. 154(b)(1)(B)(iii) 
concerning the period of pendency consumed by delays in the processing 
of the application requested by the applicant are treated in Sec. 1.704 
as such delays are also circumstances constituting a failure of an 
applicant to engage in reasonable efforts to conclude processing or 
examination of the application.
    Section 1.703(c) as proposed indicates that the period of 
adjustment under Sec. 1.702(c) is the sum of the following periods (to 
the extent that such periods are not overlapping): (1) The number of 
days, if any, in the period beginning on the date an interference was 
declared or redeclared to involve the application in the interference 
and ending on the date that the interference was terminated with 
respect to the application; and (2) the number of days, if any, in the 
period beginning on the date prosecution in the application was 
suspended by the Office due to interference proceedings under 35 U.S.C. 
135(a) not involving the application and ending on the date of the 
termination of the suspension.
    Section 1.703(d) as proposed indicates that the period of 
adjustment under Sec. 1.702(d) is the sum of the following periods (to 
the extent that such periods are not overlapping): (1) The number of 
days, if any, the application was maintained in a sealed condition 
under 35 U.S.C. 181; (2) the number of days, if any, in the period 
beginning on the date of mailing of an examiner's answer under 
Sec. 1.193 in the application under secrecy order and ending on the 
date the secrecy order was removed; (3) the number of days, if any, in 
the period beginning on the date applicant was notified that an 
interference would be declared but for the secrecy order and ending on 
the date the secrecy order was removed; and (4) the number of days, if 
any, in the period beginning on the date of notification under 
Sec. 5.3(c) and ending on the date of mailing of the notice of 
allowance under Sec. 1.311.
    Section 1.703(e) as proposed indicates that the period of 
adjustment under Sec. 1.702(e) is the sum of the number of days, if 
any, in the period beginning on the date on which a notice of appeal to 
the Board of Patent Appeals and Interferences was filed under 35 U.S.C. 
134 and Sec. 1.191 and ending on the date of a final decision in favor 
of the applicant by the Board of Patent Appeals and Interferences or by 
a Federal court in an appeal under 35 U.S.C. 141 or a civil action 
under 35 U.S.C. 145.
    Section 1.703(f) as proposed indicates that the adjustment will run 
from the expiration date of the patent as set forth in 35 U.S.C. 
154(a)(2). Section 1.703(f) also indicates that to the extent that 
periods of adjustment attributable to the grounds specified in 
Sec. 1.702 overlap, the period of adjustment will not exceed the actual 
number of days the issuance of the patent was delayed (35 U.S.C. 
154(b)(2)(A)). Section 1.703(f) as proposed also specifically indicates 
that 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 Sec. 1.703(a) through (e), to the extent that such periods are 
not overlapping, less the sum of the periods calculated under 
Sec. 1.704. Section 1.703(f) as proposed also provides that the date 
indicated on any certificate of mailing or transmission under Sec. 1.8 
shall not be taken into account in this calculation. That is, while the 
date indicated on any certificate of mailing or transmission under 
Sec. 1.8 will continue to be taken into account in determining 
timeliness, the date of filing (Sec. 1.6) will be the date used in a 
patent term adjustment calculation. Applicant may wish to consider the 
use of the ``Express Mail Post Office to Addressee'' service of the 
United States Postal Service (Sec. 1.10) for replies (as well as 
original applications) to be accorded the earliest possible filing date 
for patent term adjustment calculations.
    Section 1.703(g) as proposed indicates that no patent, the term of 
which has been disclaimed beyond a specified date, shall be adjusted 
under Secs. 1.702 and 1.703 beyond the expiration date specified in the 
disclaimer (35 U.S.C. 154(b)(2)(B)).
    Section 1.704 as proposed implements the provisions of 35 U.S.C. 
154(b)(2)(C). 35 U.S.C. 154(b)(2)(C) specifies certain circumstances as 
constituting a failure of an applicant to engage in reasonable efforts 
to conclude processing or examination of an application, and also 
provides for the Office to prescribe regulations establishing 
circumstances that constitute a failure of an applicant to engage in 
reasonable efforts to conclude processing or examination of the 
application.
    Section 1.704(a) as proposed implements the provisions of 35 U.S.C. 
154(b)(2)(C)(i) and indicates that the period of adjustment shall be 
reduced by a period equal to the period of time during which the 
applicant failed to engage in reasonable efforts to conclude 
prosecution (i.e., processing or examination) of the application.
    Section 1.704(b) as proposed provides that with respect to the 
ground for adjustments set forth in Sec. 1.702(a) though (e), and in 
particular Sec. 1.702(b), an applicant shall be deemed to have failed 
to engage in reasonable efforts to conclude prosecution for the 
cumulative total of any periods of time in excess of three months that 
are taken to reply to any notice or action by the Office making any 
rejection, objection, argument, or other request, measuring such three-
month period from the date the notice or action was mailed or given to 
the applicant. A Notice of Omitted Items (PTO-1669) is not a notice or 
action by the Office making a rejection, objection, argument, or other 
request within the meaning of 35 U.S.C. 154(b)(2)(C)(ii) or 
Sec. 1.704(b), since the Office does not require a reply to that notice 
to continue the processing and examination of the application. The 
three-month period in 35 U.S.C. 154(b)(2)(C)(ii) and Sec. 1.704(b) 
applies regardless of the period for reply set in the Office action or 
notice. For example, if an Office action sets a one-month period for 
reply (restriction requirement), the applicant may obtain a two-month 
extension of time under Sec. 1.136(a) before being subject to a 
reduction of patent term adjustment under 35 U.S.C. 154(b)(2)(C)(ii) 
and Sec. 1.704(b). If, however, an Office action set a six-month period 
for reply, as is commonly set in applications subject to secrecy orders 
(see section 130 of the Manual of Patent Examining Procedure (7th ed. 
1998) (MPEP)), the applicant is subject to a reduction of patent term 
adjustment under 35 U.S.C. 154(b)(2)(C)(ii) and Sec. 1.704(b) if the 
applicant does not reply to the Office action within three months, 
notwithstanding that a reply may be timely filed six months after the 
mailing date of the Office action. Section 1.704(b) as proposed 
indicates that in such a case the period of adjustment set forth in 
Sec. 1.703 shall be reduced by the number of days, if any, beginning on 
the date three months after the date of mailing of the Office 
communication notifying the applicant of the rejection, objection, 
argument, or other request and ending on the date the reply was filed.
    Section 1.704(c) as proposed also establishes further circumstances 
that constitute a failure of an applicant to engage in reasonable 
efforts to conclude processing or examination of the application. 
Section 1.704(c)(1) through (c)(16) set forth actions or inactions by 
an applicant that interfere with the Office's ability to process or 
examine an

[[Page 17219]]

application (and thus circumstances that constitute a failure of an 
applicant to engage in reasonable efforts to conclude processing or 
examination of the application), as well as the period by which a 
period of adjustment set forth in Sec. 1.703 shall be reduced if an 
applicant engages in any of the enumerated actions or inactions. 
Sections 1.704(c)(1) through 1.704(c)(16) address situations that occur 
with sufficient frequency to warrant being specifically provided for in 
the rules of practice. An attempt to provide an exhaustive listing of 
actions or inactions that interfere with the Office's ability to 
process or examine an application, but do not occur with great 
frequency (e.g., applicant files and persists in requesting 
reconsideration of a meritless petition under Sec. 1.10 or when the 
scope of the broadest claim in the application at the time an 
application is placed in condition for allowance is substantially the 
same as suggested or allowed by the examiner more than six months 
earlier than the date the application was placed in condition for 
allowance), is impractical. Thus, the actions or inactions set forth in 
Sec. 1.704(c) are exemplary circumstances that constitute a failure of 
an applicant to engage in reasonable efforts to conclude processing or 
examination of the application. The Office may also reduce a period of 
adjustment provided in Sec. 1.703 on the basis of conduct that 
interferes with the Office's ability to process or examine an 
application under the authority provided in 35 U.S.C. 
154(b)(2)(C)(iii), even if such conduct is not specifically addressed 
in Sec. 1.704(c).
    Section 1.704(c)(1) as proposed establishes suspension of action 
under Sec. 1.103 at the applicant's request as a circumstance that 
constitutes a failure of an applicant to engage in reasonable efforts 
to conclude processing or examination of an application. Obviously, if 
action is suspended at the applicant's request, the Office is precluded 
from processing or examining the application as a result of an action 
by the applicant. Section 1.704(c)(1) as proposed also provides that in 
such a case the period of adjustment set forth in Sec. 1.703 shall be 
reduced by the number of days, if any, beginning on the date a request 
for suspension of action under Sec. 1.103 was filed and ending on the 
date of the termination of the suspension.
    Section 1.704(c)(2) as proposed establishes deferral of issuance of 
a patent under Sec. 1.314 as a circumstance that constitutes a failure 
of an applicant to engage in reasonable efforts to conclude processing 
or examination of an application. Obviously, if issuance of the patent 
is deferred under Sec. 1.314, the Office is precluded from issuing the 
application as a result of an action by the applicant. When a petition 
under Sec. 1.314 is granted, the petition decision generally states 
that the application will be held for a period of a month to await the 
filing of a paper. At the end of the period, the application is 
returned to the issue process without a further communication from the 
Office to the applicant. Section 1.704(c)(2) as proposed also provides 
that in such a case the period of adjustment set forth in Sec. 1.703 
shall be reduced by the number of days, if any, beginning on the date a 
request for deferral of issuance of a patent under Sec. 1.314 was filed 
and ending on the issue date of the patent.
    Section 1.704(c)(3) as proposed establishes abandonment of the 
application or late payment of the issue fee as a circumstance that 
constitutes a failure of an applicant to engage in reasonable efforts 
to conclude processing or examination of an application. Obviously, if 
the application is abandoned (either by failure to prosecute or late 
payment of the issue fee), the Office is precluded from processing or 
examining the application as a result of an action or inaction by the 
applicant. Section 1.704(c)(3) as proposed also provides that in such a 
case the period of adjustment set forth in Sec. 1.703 shall be reduced 
by the number of days, if any, beginning on the date of abandonment or 
the date after the day the issue fee was due and ending on the date of 
mailing of the decision reviving the application or accepting late 
payment of the issue fee.
    Section 1.704(c)(4) as proposed establishes failure to file a 
petition to withdraw a holding of abandonment or to revive an 
application within two months from the mailing date of a notice of 
abandonment as a circumstance that constitutes a failure of an 
applicant to engage in reasonable efforts to conclude processing or 
examination of an application. Any applicant who considers an 
application to have been improperly held abandoned (the reduction in 
Sec. 1.704(c)(3) is applicable to the revival of an application 
properly held abandoned) is expected to file a petition to withdraw the 
holding of abandonment (or to revive the application) within two months 
from the mailing date of a notice of abandonment. See MPEP 
711.03(c)(I). Section 1.704(c)(4) as proposed also provides that in 
such a case the period of adjustment set forth in Sec. 1.703 shall be 
reduced by the number of days, if any, beginning on the date two months 
from the mailing date of a notice of abandonment and ending on the date 
a petition to withdraw the holding of abandonment or to revive the 
application was filed.
    Section 1.704(c)(5) as proposed establishes conversion of a 
provisional application under 35 U.S.C. 111(b) to a nonprovisional 
application under 35 U.S.C. 111(a) (pursuant to 35 U.S.C. 111(b)(5)) as 
a circumstance that constitutes a failure of an applicant to engage in 
reasonable efforts to conclude processing or examination of an 
application. Section 4801(a) of the ``American Inventors Protection Act 
of 1999'' provides for the conversion of a provisional application 
under 35 U.S.C. 111(b) and Sec. 1.53(c) to a nonprovisional application 
under 35 U.S.C. 111(a) and Sec. 1.53(b), and it is being implemented in 
a separate rulemaking. Conversion of a provisional application to a 
nonprovisional application will require the Office to reprocess the 
application (as a nonprovisional application) up to one year after the 
filing date that will be accorded to such nonprovisional application as 
a result of an action by the applicant. Section 1.704(c)(5) as proposed 
also provides that in such a case the period of adjustment set forth in 
Sec. 1.703 shall be reduced by the number of days, if any, beginning on 
the date the application was filed under 35 U.S.C. 111(b) and ending on 
the date a request in compliance with Sec. 1.53(c)(3) to convert the 
provisional application into a nonprovisional application was filed.
    Section 1.704(c)(6) as proposed establishes failure to file the 
basic filing fee (Sec. 1.16(a) or (g)), any English translation 
required by Sec. 1.52(d), or an oath or declaration (Sec. 1.63) 
executed by all of the inventors in an application under 35 U.S.C. 
111(a) as a circumstance that constitutes a failure of an applicant to 
engage in reasonable efforts to conclude processing or examination of 
an application. The Office cannot act on an application until the 
applicant files the basic filing fee, an English translation (if the 
application is filed in a language other than English), and an oath or 
declaration (Sec. 1.63) executed in compliance with Sec. 1.64 (by all 
of the inventors or applicants under Secs. 1.42, 1.43, or 1.47). The 
rules of practice (Sec. 1.53(f) and 1.136(a)), however, currently 
permit an applicant to delay filing the basic filing fee, any English 
translation required by Sec. 1.52(d), and oath or declaration by up to 
seven months from the date the applicant is notified that the 
application is missing the basic filing fee, English translation, or 
oath or declaration. To avoid changing these provisions and

[[Page 17220]]

requiring that the basic filing fee and oath or declaration be filed 
when an application is filed under 35 U.S.C. 111(a), the Office is 
setting forth failure to file the basic filing fee (Sec. 1.16(a) or 
(g)), any English translation required by Sec. 1.52(d), or an oath or 
declaration (Sec. 1.63) executed by all of the inventors in an 
application under 35 U.S.C. 111(a) as a circumstance that constitutes a 
failure of an applicant to engage in reasonable efforts to conclude 
processing of the application. Section 1.704(c)(6) as proposed provides 
that in such a case the period of adjustment set forth in Sec. 1.703 
shall be reduced by the number of days, if any, beginning on the date 
the application was filed and ending on the later of the date the 
applicant supplied the basic filing fee (Sec. 1.16), an English 
translation (Sec. 1.52(d)), and an oath or declaration (Sec. 1.63) 
executed in compliance with Sec. 1.64 and, if the oath or declaration 
was not executed by all of the inventors, the earliest of the date the 
application was accorded status under Sec. 1.47, or four months after a 
grantable petition under Sec. 1.47 was filed.
    Section 1.704(c)(7) as proposed establishes failure to fulfill the 
requirements of 35 U.S.C. 371(c) and Sec. 1.494 or Sec. 1.495 in an 
international application as a circumstance that constitutes a failure 
of an applicant to engage in reasonable efforts to conclude processing 
of an application. The three-year period in 35 U.S.C. 154(b)(1)(B) is 
measured from the ``actual filing date of the application in the United 
States'' and 35 U.S.C. 363 provides that an international application 
designating the United States has the same effect from its 
international filing date as a national application regularly filed in 
the United States (except as provided in 35 U.S.C. 102(e)). 
Nevertheless, the Office cannot act on an international application 
until the applicant fulfills the requirements of 35 U.S.C. 371(c) and 
Sec. 1.494 or Sec. 1.495, and the legislative history of 35 U.S.C. 
154(b) makes clear that an applicant may not use the Patent Cooperation 
Treaty (PCT) application filing system to have the time period set 
forth in Sec. 1.494 or Sec. 1.495 count against the three-year time 
period in 35 U.S.C. 154(b)(1)(B). See 145 Cong. Rec. S14708, S14718 
(daily ed. November 17, 1999) (statement of Sen. Lott); see also H.R. 
Rep. No. 106-464 at 126 (1999). Section 1.704(c)(7) as proposed also 
provides that in such a case the period of adjustment set forth in 
Sec. 1.703 shall be reduced by the number of days, if any, beginning on 
the date the international application was filed under 35 U.S.C. 363 
and the later of the date the application fulfilled the requirements of 
35 U.S.C. 371(c) and Secs. 1.494 or 1.495 and, if the oath or 
declaration was not executed by all of the inventors (Sec. 1.497), the 
earliest of the date the application was accorded status under 
Sec. 1.47, or four months after a grantable petition under Sec. 1.47 
was filed.
    Section 1.704(c)(8) as proposed establishes failure to request the 
national stage of processing in an international application if the 
application fulfills the requirements of 35 U.S.C. 371(c) and 
Sec. 1.494 or Sec. 1.495 before the expiration of the applicable time 
period set forth in Sec. 1.494(b) or Sec. 1.495(b) as a circumstance 
that constitutes a failure of an applicant to engage in reasonable 
efforts to conclude processing or examination of an application. The 
Office cannot act on an international application before the expiration 
of the applicable time period set forth in Sec. 1.494(b) or 
Sec. 1.495(b) without the applicant's express request (35 U.S.C. 
371(f)), even if the application fulfills the requirements of 35 U.S.C. 
371(c) and Sec. 1.494 or Sec. 1.495 prior to the expiration of the 
applicable time period set forth in Sec. 1.494(b) or Sec. 1.495(b). 
Section 1.704(c)(8) as proposed also provides that in such a case the 
period of adjustment set forth in Sec. 1.703 shall be reduced by the 
number of days, if any, beginning on the date the international 
application was filed under 35 U.S.C. 363 and the earlier of the date 
of expiration of the applicable time period in Sec. 1.494(b) or 
Sec. 1.495(b) or the date on which an express request for national 
stage of processing is filed.
    Section 1.704(c)(9) as proposed establishes failure to file an 
application with a specification on papers in compliance with Sec. 1.52 
and having a title and abstract in compliance with Sec. 1.72, drawings 
in compliance with Sec. 1.84 (if applicable), and a sequence listing in 
compliance with Secs. 1.821 through 1.825 (if applicable) as a 
circumstance that constitutes a failure of an applicant to engage in 
reasonable efforts to conclude processing or examination of an 
application. The Office must require these items during its 
preexamination processing of an application to implement the pre-grant 
publication provisions of the ``American Inventors Protection Act of 
1999.'' Therefore, the Office cannot act on an application until it 
contains a specification on papers in compliance with Sec. 1.52 and 
having an abstract (Sec. 1.72(b)), drawings in compliance with 
Sec. 1.84 (if applicable), and a sequence listing in compliance with 
Secs. 1.821 through 1.825 (if applicable). Section 1.704(c)(9) as 
proposed also provides that in such a case the period of adjustment set 
forth in Sec. 1.703 shall be reduced by the number of days, if any, 
beginning on the filing date of the application and ending on the date 
the application contains a specification on papers in compliance with 
Sec. 1.52 and having an abstract (Sec. 1.72(b)), drawings in compliance 
with Sec. 1.84 (if applicable), and a sequence listing in compliance 
with Secs. 1.821 through 1.825 (if applicable).
    Section 1.704(c)(10) as proposed establishes submission of a 
preliminary amendment or other preliminary paper less than one month 
before the mailing of an Office action under 35 U.S.C. 132 or a notice 
of allowance under 35 U.S.C. 151 that requires the mailing of a 
supplemental Office action or notice of allowance as a circumstance 
that constitutes a failure of an applicant to engage in reasonable 
efforts to conclude processing or examination of an application. If the 
submission of a preliminary amendment or other paper requires the 
Office to issue a supplemental Office action or notice of allowance, 
the submission of that preliminary amendment or other paper has 
interfered with the processing and examination of an application. 
Section 1.704(c)(10) as proposed also provides that in such a case the 
period of adjustment set forth in Sec. 1.703 shall be reduced by the 
number of days, if any, beginning on the mailing date of the original 
Office action or notice of allowance and ending on the mailing date of 
the supplemental Office action or notice of allowance.
    Section 1.704(c)(11) as proposed establishes submission of a reply 
having an omission (Sec. 1.135(c)) as a circumstance that constitutes a 
failure of an applicant to engage in reasonable efforts to conclude 
processing or examination of an application. Submitting a reply having 
an omission requires the Office to issue an action under Sec. 1.135(c) 
and await and process the applicant's reply before the initial reply 
(as completed) can be treated on its merits. Section 1.704(c)(11) as 
proposed also provides that in such a case the period of adjustment set 
forth in Sec. 1.703 shall be reduced by the number of days, if any, 
beginning on the date the reply having an omission was filed and ending 
on the date that the omission was filed.
    Section 1.704(c)(12) as proposed establishes submission of a 
supplemental reply or other paper after a reply has been filed as a 
circumstance that constitutes a failure of an applicant to engage in 
reasonable efforts to conclude processing or examination of an 
application. The submission of a

[[Page 17221]]

supplemental reply or other paper (e.g., IDS or petition) after an 
initial reply was filed requires the Office to restart consideration of 
the initial reply in view of the supplemental reply or other paper, 
which will result in a delay in the Office's response to the initial 
reply. Section 1.704(c)(12) as proposed also provides that in such a 
case the period of adjustment set forth in Sec. 1.703 shall be reduced 
by the number of days, if any, beginning on the date the initial reply 
was filed and ending on the date that the supplemental reply or such 
other paper was filed.
    Section 1.704(c)(13) as proposed establishes failure to file an 
appeal brief (and brief fee) in compliance with Sec. 1.192 with the 
notice of appeal to the Board of Patent Appeals and Interferences under 
35 U.S.C. 134 and Sec. 1.191 as a circumstance that constitutes a 
failure of an applicant to engage in reasonable efforts to conclude 
processing or examination of an application. The examiner cannot 
prepare an examiner's answer in response to an appeal until the 
applicant files an appeal brief in compliance with Sec. 1.192, and the 
rules of practice (Secs. 1.192(a) and 1.136(a)) now allow the applicant 
to delay filing an appeal brief for up to seven months from the filing 
date of the notice of appeal under Sec. 1.191. Thus, to continue to 
permit this time frame for filing an appeal brief, the Office must 
establish the failure to file an appeal brief (and brief fee) in 
compliance with Sec. 1.192 with the notice of appeal to the Board of 
Patent Appeals and Interferences under 35 U.S.C. 134 and Sec. 1.191 as 
a circumstance that constitutes a failure of an applicant to engage in 
reasonable efforts to conclude processing or examination of the 
application. Section 1.704(c)(13) as proposed also provides that in 
such a case the period of adjustment set forth in Sec. 1.703 shall be 
reduced by the number of days, if any, beginning on the date a notice 
of appeal under 35 U.S.C. 134 and Sec. 1.191 was filed and ending on 
the day an appeal brief (and brief fee) in compliance with Sec. 1.192 
was filed, or, if no appeal brief under Sec. 1.192 is filed, ending on 
the day an amendment in compliance with Sec. 1.113 was filed.
    Section 1.704(c)(14) as proposed establishes submission of an 
amendment or other paper in an application containing allowed claims 
after a decision by the Board of Patent Appeals and Interferences 
(other than a decision containing a rejection under Sec. 1.196(b)) or a 
Federal court less than one month before the mailing of an Office 
action under 35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151 
that requires the mailing of a supplemental Office action or 
supplemental notice of allowance as a circumstance that constitutes a 
failure of an applicant to engage in reasonable efforts to conclude 
processing or examination of the application. The submission of an 
amendment or other paper (e.g., IDS or petition) in an application 
after a Board of Patent Appeals and Interferences or court decision 
requires the Office to restart consideration of the application in view 
of the amendment or other paper, which will result in a delay in the 
Office's taking action on the application. Section 1.704(c)(14) as 
proposed also provides that in such a case the period of adjustment set 
forth in Sec. 1.703 shall be reduced by the number of days, if any, 
beginning on the mailing date of the original Office action or notice 
of allowance and ending on the mailing date of the supplemental Office 
action or notice of allowance.
    Section 1.704(c)(15) as proposed establishes submission of an 
amendment under Sec. 1.312 or other paper after a notice of allowance 
has been given or mailed as a circumstance that constitutes a failure 
of an applicant to engage in reasonable efforts to conclude processing 
or examination of an application. The submission of amendments (or 
other papers) after an application is allowed causes substantial 
interference with the patent issue process. See Filing of Continuing 
Applications, Amendments, or Petitions after Payment of Issue Fee, 
Notice, 1221 Off. Gaz. Pat. Office 14 (April 6, 1999); and Patents to 
Issue More Quickly After Issue Fee Payment, Notice, 1220 Off. Gaz. Pat. 
Office 42 (March 9, 1999). Thus, to continue to permit applicants to 
submit an amendment or other paper after a notice of allowance is 
mailed or given, the Office must establish submission of an amendment 
under Sec. 1.312 or other paper after a notice of allowance has been 
given or mailed as a circumstance that constitutes a failure of an 
applicant to engage in reasonable efforts to conclude processing or 
examination of the application. Section 1.704(c)(15) as proposed also 
provides that in such a case the period of adjustment set forth in 
Sec. 1.703 shall be reduced by the lesser of: (1) The number of days, 
if any, beginning on the date the amendment under Sec. 1.312 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 (2) 
four months. The ``lesser of * * * or four months'' provision is to 
provide a four-month cap for reductions under Sec. 1.704(c)(15).
    Section 1.704(c)(16) as proposed establishes further prosecution 
via a continuing application as a circumstance that constitutes a 
failure of an applicant to engage in reasonable efforts to conclude 
processing or examination of the application. Currently, a continuing 
application may be used to: (1) Obtain further examination of an 
invention disclosed and claimed in the prior application (continuation 
application); (2) obtain examination (for the first time) of an 
invention disclosed but not claimed or not elected for examination in 
the prior application (divisional application); or (3) obtain 
examination of an invention neither disclosed nor claimed in the prior 
application (continuation-in-part application). The provisions of 35 
U.S.C. 132(b) (which are being implemented in a separate rulemaking) 
will permit an applicant to obtain further or continued examination of 
an invention disclosed and claimed in an application, which renders it 
unnecessary for an applicant whose application is eligible for patent 
term adjustment under 35 U.S.C. 154(b) to file a continuing application 
to obtain further examination of an invention disclosed and claimed in 
an application. If an applicant is filing a continuing application to 
obtain examination (for the first time) of an invention disclosed but 
not claimed or not elected for examination in the prior application or 
an invention neither disclosed nor claimed in the prior application, it 
is not appropriate for that applicant to obtain any benefit in the 
continuing application for examination delays that might have occurred 
in the prior application. Thus, the Office is establishing further 
prosecution via a continuing application as a circumstance that 
constitutes a failure of an applicant to engage in reasonable efforts 
to conclude processing or examination of the application, in that the 
period of adjustment set forth in Sec. 1.703 shall not include any 
period that is prior to the actual filing date of the application that 
resulted in the patent. Thus, if the application that resulted in the 
patent is a CPA, the period of adjustment set forth in Sec. 1.703 (if 
any) will not include any period that is prior to the filing date of 
the request for that CPA.
    As discussed above, an applicant may file a CPA under Sec. 1.53(d) 
on or after May 29, 2000, for the application to be subject to the 
patent term adjustment provisions of 35 U.S.C. 154(b) as amended by 
Sec. 4402 of the ``American Inventors Protection Act of 1999.'' The 
period of patent term adjustment Sec. 1.703

[[Page 17222]]

(if any), however, will not include any period that is prior to the 
filing date of the request for that CPA.
    These are three examples of how 35 U.S.C. 154(b) and the proposed 
rules to implement 35 U.S.C. 154(b) would apply. For purposes of 
clarity and ease of calculation, the examples illustrate mailing of 
some Office actions on non-business days, and granting of patents on 
days other than Tuesdays.
    In a first example: (1) A first application (``Application A'') is 
filed on January 2, 1998; (2) a second application (``Application B'') 
is filed as a continued prosecution application (CPA under 
Sec. 1.53(d)) of Application A on May 29, 2000, without payment of the 
filing fee or providing a deposit account authorization for payment of 
the filing fee; (3) a ``Notice to File Missing Parts of Application 
(CPA)'' is mailed on July 25, 2000, requiring the filing fee, and 
setting a two-month period for reply; (4) the filing fee is paid on 
September 25, 2000; (5) a written restriction requirement is mailed on 
November 13, 2000; (6) a petition for a four-month extension of time 
and an election are filed on April 6, 2001; (7) an Office action (first 
action on the merits) is mailed on September 10, 2001; (8) an amendment 
is filed in reply (Sec. 1.111) to that Office action on November 1, 
2001; (9) a notice of allowability requiring a biological material 
deposit (Sec. 1.809(c)) and notice of allowance are mailed on December 
3, 2001; (10) the issue fee is paid on February 28, 2002; (11) the 
biological material deposit is made on March 15, 2002, with a one-month 
extension of time; and (12) the patent issues on July 9, 2002.
    The fourteen-month time period set forth in 35 U.S.C. 
154(b)(1)(A)(i)(Sec. 1.702(a)(1) and Sec. 1.703(a)(1)) was met by the 
mailing of the written restriction requirement on November 13, 2000, 
within fourteen months of the filing date of the application (May 29, 
2000). The four-month time period set forth in 35 U.S.C. 
154(b)(1)(A)(ii)(Sec. 1.702(a)(2) and Sec. 1.703(a)(2)) was not met for 
acting on the reply (election) of April 6, 2001, but was met for acting 
on the reply (amendment) of November 1, 2001. The four-month time 
period for acting on the reply of April 6, 2001, expired on August 6, 
2001; however, the Office's response to the reply of April 6, 2001, was 
not mailed until September 10, 2001, the difference in time between 
August 6, 2001, and September 10, 2001, being 35 days. The four-month 
time period set forth in 35 U.S.C. 154(b)(1)(A)(iii)(Sec. 1.702(a)(2) 
through (a)(3) and Sec. 1.703(a)(3) through (a)(4)) is not applicable 
in this example. The four-month time period set forth in 35 U.S.C. 
154(b)(1)(A)(iv)(Sec. 1.702(a)(4) and Sec. 1.703(a)(6)) was met as all 
formal requirements were satisfied on March 15, 2002, and the patent 
was issued on July 9, 2002 (within four months of March 15, 2002). As 
the application (Application B) was pending for less than three years 
(from May 29, 2000, until July 9, 2002), there is no adjustment 
pursuant to 35 U.S.C. 154(b)(1)(B)(Sec. 1.702(b) and Sec. 1.703(b)). In 
addition, as there was also no interference, secrecy order or appellate 
review in the application, there is no adjustment pursuant to 35 U.S.C. 
154(b)(1)(C)(Sec. 1.702(b) through (e) and Sec. 1.703(c) through (e)).
    35 U.S.C. 154(b)(2)(C)(i) provides that the period of adjustment 
shall be reduced by the period of time during which applicant failed to 
engage in reasonable efforts to conclude prosecution of the 
application. Section 1.704(b) as proposed sets forth that any time 
periods in excess of three months taken to reply to any notice or 
action by the Office shall each be deemed failures to engage in 
reasonable efforts to conclude prosecution of an application, and that 
the period of adjustment shall be reduced by the period of time 
beginning on the date three months after the date of mailing of the 
Office communication notifying the applicant of the rejection, 
objection, argument, or other request and ending on the date the reply 
was filed. In this example, the period of time from three months after 
the written restriction (February 13, 2001) until the reply (April 6, 
2001) is 52 days, and the period of time from three months after the 
notice of allowance (March 3, 2002) and the date the biological 
material deposit was made (March 15, 2002) is 12 days, for a total 
reduction under Sec. 1.704(b) of 64 days. Sections 1.704(c)(1) through 
1.704(c)(16) as proposed set forth actions or inactions, each of which 
further constitutes a failure by the applicant to engage in reasonable 
efforts to conclude prosecution of an application. As applicable in 
this example, proposed Sec. 1.704(c)(6) provides that a failure to file 
the basic filing fee of an application on filing will result in a 
reduction of any period of adjustment (Sec. 1.703) by the period 
between the application filing date and the submission of the basic 
filing fee, and proposed Sec. 1.704(c)(16) provides that the period of 
adjustment (Sec. 1.703) shall not include any period that is prior to 
the actual filing date of the application that resulted in the patent. 
In this example, the period of time from filing of Application B (May 
29, 2000) until submission of the basic filing fee (September 25, 2000) 
is 119 days, and the period of adjustment does not include any period 
that is prior to May 29, 2000 (the actual filing date of Application 
B).
    Accordingly, the total period during which applicant failed to 
engage in reasonable efforts to conclude prosecution would be 64 days 
(1.704(b)) plus 119 days (1.704(c)) for a total of 183 days. It should 
be noted that the reduction attributed to the extension of time 
(Sec. 1.704(b)) may be reduced if a proper showing pursuant to 
Sec. 1.705(c) is submitted after mailing of the notice of allowance and 
before or with payment of the issue fee.
    In this example, the period of adjustment pursuant to 35 U.S.C. 
154(b)(1)(Sec. 1.702 and Sec. 1.703) is 35 days, which is reduced by 
the 183-day period in which applicant failed to engage in reasonable 
efforts to conclude prosecution (Sec. 1.704). Since 35 is less than 
183, there is no adjustment to the term of the patent issuing on 
Application B, whose projected expiration date remains January 2, 2018.
    In a second example: (1) An application is filed which includes a 
sequence listing as required by Sec. 1.821(c) on March 1, 2001; (2) a 
PTOL-1661 Notice stating that the computer readable form (CRF) was not 
in compliance with the requirements of Sec. 1.824 was mailed by the 
Office on April 1, 2001; (3) Applicant submits a substitute or 
corrected CRF on May 1, 2001; (4) a second PTOL-1661 Notice stating 
that the corrected or substitute CRF is not in compliance with the 
requirements of Sec. 1.824 was mailed by the Office on June 1, 2001; 
(5) a second corrected CRF is submitted on July 1, 2001; (6) a third 
PTOL-1661 Notice stating that the corrected or substitute CRF is not in 
compliance with the requirements of Sec. 1.824 was mailed by the Office 
on September 1, 2001; (7) a third corrected CRF is submitted on October 
1, 2001; (8) a fourth PTOL-1661 Notice stating that the corrected or 
substitute CRF is not in compliance with the requirements of Sec. 1.824 
was mailed by the Office on December 1, 2002; (9) a fourth corrected 
CRF is submitted on January 1, 2002; (10) a fifth PTOL-1661 Notice 
stating that the corrected or substitute CRF is not in compliance with 
the requirements of Sec. 1.824 was mailed by the Office on February 1, 
2002; (11) a proper CRF submission is filed on March 1, 2002; (12) an 
Office action (first action on the merits) is mailed on July 1, 2002; 
(13) an amendment is filed in reply (Sec. 1.111) to that Office action 
on October 1, 2002;

[[Page 17223]]

(14) a second Office action is mailed on February 1, 2003; (15) an 
amendment is filed in reply to the second Office action on May 1, 2003; 
(16) a third (final) Office action is mailed on September 1, 2003; (17) 
an amendment is filed, which adopts the allowable subject matter noted 
in the final Office action, on November 1, 2003; (18) a notice of 
allowance and notice of allowability are mailed by the Office on 
December 1, 2003; (19) applicant provides the issue fee on January 1, 
2004; (20) the patent issues on March 1, 2004.
    The fourteen-month period set forth in 35 U.S.C. 154(b)(1)(A)(i) 
(Secs. 1.702(a)(1) and 1.703(a)(1)) was not met by the mailing of the 
first Office action on July 1, 2002, by a 61-day period. The four-month 
time period set forth in 35 U.S.C. 154(b)(1)(A)(ii) (Sec. 1.702(a)(2) 
and Sec. 1.703(a)(2)) was met for acting on the replies of October 1, 
2002, May 1, 2003, and November 1, 2003. The four-month time period set 
forth in 35 U.S.C. 154(b)(1)(A)(iv)(Sec. 1.702(a)(4) and 
Sec. 1.703(a)(6)) was met as all formal requirements were satisfied on 
January 1, 2004, and the patent was issued on March 1, 2004 (within 
four months of January 1, 2004). As the application was pending for 
three years (from March 1, 2001, to March 1, 2004), there is no 
adjustment pursuant to 35 U.S.C. 154(b)(1)(B)(Sec. 1.702(b) and 
Sec. 1.703(b)). In addition, as there was also no interference, secrecy 
order or appellate review in the application, there is no adjustment 
pursuant to 35 U.S.C. 154(b)(1)(C)(Sec. 1.702(b) through (e) and 
Sec. 1.703(c) through (e)).
    35 U.S.C. 154(b)(2)(C)(i) provides that the period of adjustment 
shall be reduced by the period of time during which applicant failed to 
engage in reasonable efforts to conclude prosecution of the 
application. Sections 1.704(b) and 1.704(c)(1) through 1.704(c)(16) as 
proposed set forth actions or inactions, each of which constitutes a 
failure by the applicant to engage in reasonable efforts to conclude 
prosecution of an application. As applicable in this example, proposed 
Sec. 1.704(c)(9) provides that a failure to file an application with a 
sequence listing in compliance with Secs. 1.821 through 1.825 will 
result in a reduction of any period of adjustment (Sec. 1.703) by the 
period between the application filing date and the date a sequence 
listing in compliance with Secs. 1.821 through 1.825 is submitted. In 
this example, the period of time from filing date (March 1, 2001) and 
the filing of the correct CRF submission (March 1, 2002) is 365 days.
    In this example, the period of adjustment pursuant to 35 U.S.C. 
154(b)(1)(Sec. 1.702 and Sec. 1.703) is 61 days, which is reduced by 
the 365-day period in which applicant failed to engage in reasonable 
efforts to conclude prosecution (Sec. 1.704). Since 61 is less than 
365, there is no adjustment to the term of the patent, whose projected 
expiration date remains March 1, 2021.
    In a third example: (1) An international application is filed in 
the United States Receiving Office on January 1, 2001; (2) a Demand for 
international preliminary examination is filed on July 1, 2002; (3) the 
documents and fees to fulfill the requirements of 35 U.S.C. 371(c) 
(Sec. 1.495) were filed on July 1, 2003; (4) an Office action is mailed 
on November 1, 2003; (5) a reply to the first Office action is filed 
May 1, 2004, with a three-month extension of time; (6) a notice of 
allowance and notice of allowability are mailed on February 1, 2009; 
(7) applicant pays the issue fee on March 1, 2009; (8) patent issues on 
July 1, 2010.
    The fourteen-month period set forth in 35 U.S.C. 154(b)(1)(A)(i) 
(Secs. 1.702(a)(1) and 1.703(a)(1)) was met by the mailing of the first 
Office action on November 1, 2003, since the fourteen-month period is 
measured from the date on which the international application fulfilled 
the requirements of 35 U.S.C. 371 (35 U.S.C. 154(b)(1)(A)(i)(II)). The 
four-month time period set forth in 35 U.S.C. 154(b)(1)(A)(ii) 
(Sec. 1.702(a)(2) and Sec. 1.703(a)(2)) was not met for acting on the 
reply of May 1, 2004, by a period of 1,614 days. The four-month time 
period set forth in 35 U.S.C. 154(b)(1)(A)(iv)(Sec. 1.702(a)(4) and 
Sec. 1.703(a)(6)) was not met as all formal requirements were satisfied 
on March 1, 2009, and the patent was issued on July 1, 2010, 365 days 
after the expiration of the four-month time period (on July 1, 2009) 
for issuing the patent. The application was pending for more than three 
years from January 1, 2001, to July 1, 2010, without continued 
examination under 35 U.S.C. 132(b), a proceeding under 35 U.S.C. 135(a) 
(interference), an order under 35 U.S.C. 181 (secrecy order), or 
appellate review.
    Therefore, there is an adjustment pursuant to 35 U.S.C. 
154(b)(1)(B) (Sec. 1.702(b) and Sec. 1.703(b)) of 2,373 days. As there 
was no interference, secrecy order or appellate review in the 
application, there is no adjustment pursuant to 35 U.S.C. 
154(b)(1)(C)(Sec. 1.702(c) through (e) and Sec. 1.703(c) through (e)).
    35 U.S.C. 154(b)(2)(C)(i) provides that the period of adjustment 
shall be reduced by the period of time during which applicant failed to 
engage in reasonable efforts to conclude prosecution of the 
application. Section 1.704(c) as proposed sets forth that any time 
periods in excess of three months taken to reply to any notice or 
action by the Office shall each be deemed failures to engage in 
reasonable efforts to conclude prosecution of an application, and that 
the period of adjustment shall be reduced by the period of time 
beginning on the date three months after the date of mailing of the 
Office communication notifying the applicant of the rejection, 
objection, argument, or other request and ending on the date the reply 
was filed. In this example, the period of time from three months after 
the Office action (November 1, 2003) until the reply (May 1, 2004) is 
90 days. Sections 1.704(c)(1) through 1.704(c)(16) as proposed set 
forth actions or inactions, each of which further constitutes a failure 
by the applicant to engage in reasonable efforts to conclude 
prosecution of an application. As applicable in this example, proposed 
Sec. 1.704(c)(7) provides that a failure to fulfill the requirements of 
35 U.S.C. 371(c) and Sec. 1.494 or Sec. 1.495 in an international 
application will result in a reduction of any period of adjustment 
(Sec. 1.703) by the period between the date the application was filed 
under 35 U.S.C. 363 and the later date the application fulfilled the 
requirements of 35 U.S.C. 371(c) and Sec. 1.494 or Sec. 1.495 or, if 
the oath or declaration (Sec. 1.497) is not executed by all of the 
inventors, the earliest of the date the application was accorded status 
under Sec. 1.47, or four months after a grantable petition under 
Sec. 1.47 was filed. In this example, the period of time from filing 
(January 1, 2001) and fulfillment of 35 U.S.C. 371(c) and Sec. 1.494 or 
Sec. 1.495 (July 1, 2003) is 911 days. The total period during which 
applicant failed to engage in reasonable efforts to conclude 
prosecution would be 90 days (1.704(b)) plus 911 days (1.704(c)) for a 
total of 1,001 days.
    As set forth in Sec. 1.703(f), the term adjustment is the sum of 
the periods calculated under Sec. 703(a)-(e), to the extent the periods 
are not overlapping, less the sum of the periods calculated under 
Sec. 1.704. In this example, the period of adjustment pursuant to 35 
U.S.C. 154(b)(1)(Sec. 1.703(b)) of 2,373 days overlaps entirely with 
the period of adjustment pursuant to 35 U.S.C. 154(b)(1)(Sec. 1.703(a)) 
of 1,979 days. Consequently, 1,001 days (the sum of the periods in 
which applicant failed to engage in reasonable efforts to conclude 
prosecution (Sec. 1.704)) is deducted from 2,373 days, which leaves a 
term adjustment of 1,372 days. As a result,

[[Page 17224]]

the projected expiration date of the patent is adjusted from January 1, 
2021, to October 4, 2024.
    Section 1.705 as proposed implements the provisions of 35 U.S.C. 
154(b)(3) and (b)(4)(B).
    Section 1.705(a) as proposed indicates that the notice of allowance 
will include notification of any patent term adjustment under 35 U.S.C. 
154(b) (35 U.S.C. 154(b)(3)(B)(i)).
    Section 1.705(b) as proposed provides that any request for review 
or reconsideration of the patent term adjustment indicated in the 
notice of allowance (except as provided in Sec. 1.705(d)) and any 
request for reinstatement of all or part of the term reduced pursuant 
to Sec. 1.704(b)(1) must be filed no later than payment of the issue 
fee but may not be filed earlier than the date of mailing of the notice 
of allowance. Section 1.705(b) as proposed provides that any such 
request must be by way of an application for patent term adjustment 
accompanied by the fee set forth in Sec. 1.18(e) and a statement of the 
facts involved. Section 1.705(b) as proposed also provides that such 
statement of facts must specify: (1) The basis or bases under 
Sec. 1.702 for the adjustment; (2) the relevant dates as specified in 
Sec. 1.703(a) through (e) for which an adjustment is sought and the 
adjustment as specified in Sec. 1.703(f) to which the patent is 
entitled; (3) whether the patent is subject to a terminal disclaimer 
and any expiration date specified in the terminal disclaimer; and (4) 
any circumstances during the prosecution of the application resulting 
in the patent that constitute a failure to engage in reasonable efforts 
to conclude processing or examination of such application as set forth 
in Sec. 1.704 (or that there were no such circumstances). Since the 
Office must complete its determination of patent term adjustment before 
proceeding to issue the patent (35 U.S.C. 154(b)(3)(D)), the Office 
must require that such application for patent term adjustment be filed 
within a non-extendable time period and set forth with particularity 
why the Office's patent term adjustment determination is not correct. 
In the absence of these requirements, the issuance of the patent will 
be further delayed by a protracted patent term adjustment determination 
proceeding.
    Section 1.705(c) as proposed implements the provisions of 35 U.S.C. 
154(b)(3)(C). Section 1.705(c) as proposed specifically provides that a 
request for reinstatement of all or part of the time reduced pursuant 
to Sec. 1.704(b)(1) for failing to reply to a rejection, objection, 
argument, or other request within three months of the date of mailing 
of the Office communication notifying the applicant of the rejection, 
objection, argument, or other request must include: (1) the fee set 
forth in Sec. 1.18(f); and (2) a showing to the satisfaction of the 
Director that, in spite of all due care, the applicant was unable to 
reply to the rejection, objection, argument, or other request within 
three months of the date of mailing of the Office communication 
notifying the applicant of the rejection, objection, argument, or other 
request. Section 1.705(c) as proposed also provides that the Office 
shall not grant any request for reinstatement for more than three 
additional months for each reply beyond three months of the date of 
mailing of the Office communication notifying the applicant of the 
rejection, objection, argument, or other request (35 U.S.C. 
154(b)(3)(C)).
    Since the Office is obligated to provide a determination of patent 
term adjustment under 35 U.S.C. 154(b) in the notice of allowance 
(i.e., before the actual patent issue date), the Office must project 
(or estimate) the actual patent issue date and base its patent term 
adjustment determination on that projection. Thus, Sec. 1.705(d) as 
proposed provides for a request to change the period of patent term 
adjustment in the event that the patent is issued on a date other than 
the projected date of issue and this change necessitates a revision of 
the patent term adjustment indicated in the notice of allowance. 
Section 1.705(d) specifically provides that if the patent is issued on 
a date other than the projected date of issue and this change 
necessitates a revision of the patent term adjustment indicated in the 
notice of allowance, the patent will indicate the revised patent term 
adjustment. Section 1.705(d) also provides that if the patent indicates 
a revised patent term adjustment due to the patent being issued on a 
date other than the projected date of issue, any request for 
reconsideration of the patent term adjustment indicated in the patent 
must be filed within thirty days of the date the patent issued and must 
comply with the requirements of Sec. 1.705(b)(1) and Sec. 1.705(b)(2).
    Section 1.705(e) as proposed provides that the periods set forth in 
this section are not extendable. As discussed above, the Office must 
set non-extendable time periods in Sec. 1.705 to avoid delay in the 
issuance of the patent.
    Section 1.705(f) as proposed implements the provisions of 35 U.S.C. 
154(b)(4)(B), and provides that no submission or petition on behalf of 
a third party concerning patent term adjustment under 35 U.S.C. 154(b) 
will be considered by the Office, and that any such submission or 
petition, will be returned to the third party, or otherwise disposed 
of, at the convenience of the Office.

Classification

Regulatory Flexibility Act

    The Chief Counsel for Regulation of the Department of Commerce 
certified to the Chief Counsel for Advocacy, Small Business 
Administration, that the changes proposed in this notice, if adopted, 
would not have a significant impact on a substantial number of small 
entities (Regulatory Flexibility Act, 5 U.S.C. 605(b)). This rulemaking 
implements the provisions of Secs. 4401 and 4402 of the ``American 
Inventors Protection Act of 1999.'' The changes proposed in this notice 
(if adopted) would provide procedures for the Office's patent term 
adjustment determination and for filing an application to request 
reconsideration of the Office's patent term adjustment determination.
    The Office mails a notice of allowance in roughly 160,000 
applications each year. The Office's patent term adjustment 
determination will be a calculation based upon time periods involving 
the dates of various actions by the Office and the applicant during the 
application process. Because of the number of actions by the Office and 
the applicant during the application process, the Office anticipates 
that there will be disagreement on at least one of these dates in 
roughly fifteen percent of applications (24,000). Based upon the 
percentage of applicants who are small entities (thirty percent), the 
Office expects that 7,200 small entities will file an application 
requesting reconsideration of a patent term adjustment determination 
each year. Since a small entity applicant who exercises reasonable due 
care or diligence should be able to reply to any Office action or 
notice within three months, the Office does not anticipate that any 
small entities will file a request for reinstatement of reduced patent 
term adjustment (based upon a showing that the applicant was unable to 
reply to an Office action or notice within three months in spite of all 
due care).
    Filing an application requesting reconsideration of a patent term 
adjustment determination (as well as a request for reinstatement of 
reduced patent term adjustment) is optional. To obtain any benefit from 
an application requesting reconsideration of the Office's patent term 
adjustment determination, the applicant must plan to pay the three 
maintenance fees required by law (35 U.S.C. 41(b)) to

[[Page 17225]]

maintain a patent in force until the end of the non-adjusted patent 
term as specified in 35 U.S.C. 154. The current first, second, and 
third maintenance fees are $415.00, $950.00, and $1,455.00, 
respectively. Since the fee ($200.00) for filing an application 
requesting reconsideration of the Office's patent term adjustment 
determination is less than one-tenth of the combined cost of these 
three maintenance fees (and the fee ($450.00) for filing a request for 
reinstatement of reduced patent term adjustment is less than one-sixth 
of the combined cost of these three maintenance fees), there will not 
be a significant economic impact on a substantial number of small 
entities due to the procedures for requesting reconsideration of the 
Office's patent term adjustment determination.

Executive Order 13132

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

Executive Order 12866

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

Paperwork Reduction Act

    This notice of proposed rulemaking 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 notice of 
proposed rulemaking has been reviewed and previously approved by OMB 
under OMB control number 0651-0020.
    As required by the Paperwork Reduction Act of 1995 (44 U.S.C. 
3507(d)), the Patent and Trademark Office has submitted an information 
collection package to OMB for its review and approval of the proposed 
information collections under OMB control number 0651-0020. The Patent 
and Trademark Office is submitting this information collection to OMB 
for its review and approval because this notice of proposed rulemaking 
will add the request for reconsideration of a patent term adjustment 
determination by the Patent and Trademark Office and the request for 
reinstatement of reduced patent term adjustment (based upon a showing 
that the applicant was unable to reply to an Office action or notice 
within three months in spite of all due care) provided for in 35 U.S.C. 
154(b)(3) to that collection.
    The title, description, and respondent description of the 
information collection is shown below with an estimate of the annual 
reporting burdens. Included in this estimate is the time for reviewing 
instructions, gathering, and maintaining the data needed, and 
completing and reviewing the collection of information. The principal 
impact of the changes in this notice of proposed rulemaking is to 
implement the changes to Office practice necessitated by Sec. 4402 of 
the ``American Inventors Protection Act of 1999'' (enacted into law by 
Sec. 1000(a)(9), Division B, of Public Law 106-113).
    OMB Number: 0651-0020.
    Title: Patent Term Extension.
    Form Numbers: None.
    Type of Review: Approved through September of 2001.
    Affected Public: Individuals or households, businesses or other 
for-profit, not-for-profit institutions, farms, Federal Government, and 
state, local, or tribal governments.
    Estimated Number of Respondents: 26,857.
    Estimated Time Per Response: 1.15 hour.
    Estimated Total Annual Burden Hours: 30,902 hours.
    Needs and Uses: The information supplied to the Patent and 
Trademark Office by an applicant requesting reconsideration of a patent 
term adjustment determination under 35 U.S.C. 154(b) (proposed 
Sec. 1.702 et seq.) is used by the 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 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 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 Patent and Trademark 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, Special Program Law Office, Patent 
and Trademark Office, Washington, D.C. 20231, or to the Office of 
Information and Regulatory Affairs of OMB, New Executive Office 
Building, 725 17th Street, N.W., Room 10235, Washington, D.C. 20503, 
Attention: Desk Officer for the 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 recordkeeping 
requirements, Small businesses.

    For the reasons set forth in the preamble, 37 CFR Part 1 is 
proposed to be amended as follows:

PART 1--RULES OF PRACTICE IN PATENT CASES

    1. The authority citation for 37 CFR Part 1 is revised to read as 
follows:

    Authority: 35 U.S.C. 2(b)(2), unless otherwise noted.

    2. Section 1.18 is amended by revising the section heading, adding 
and reserving paragraph (d), and adding paragraphs (e) and (f) to read 
as follows:


Sec. 1.18  Patent post allowance (including issue) fees.

* * * * *
    (d) [Reserved]
    (e) For filing an application for patent term adjustment under 
Sec. 1.705--$200.00
    (f) For filing a request for reinstatement of all or part of the 
term reduced pursuant to Sec. 1.704(b) in an application for patent 
term adjustment under Sec. 1.705--$450.00

Subpart F--Adjustment and Extension of Patent Term

    3. The heading of subpart F is revised to read as set forth above.
    4. An undesignated center heading is added to Subpart F Sec. 1.701 
to read as follows:

[[Page 17226]]

Adjustment of Patent Term due to Examination Delay
    5. Section 1.701 is amended by revising the section heading and 
adding paragraph (e) 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).

* * * * *
    (e) The provisions of this section apply only to original patents, 
except for design patents, issued on applications filed on or after 
June 8, 1995.
    6. Sections 1.702 through 1.705 are added 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).

    (a) Failure to take certain actions within specified time frames. 
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 the failure of the Office to:
    (1) Mail at least one of a notification under 35 U.S.C. 132 or a 
notice of allowance under 35 U.S.C. 151 not later than fourteen months 
after the date on which the application was filed under 35 U.S.C. 
111(a) or fulfilled the requirements of 35 U.S.C. 371;
    (2) Respond to a reply under 35 U.S.C. 132 or to an appeal taken 
under 35 U.S.C. 134 not later than four months after the date on which 
the reply was filed or the appeal was taken;
    (3) Act on an application not later than four months after the date 
of a decision by the Board of Patent Appeals and Interferences under 35 
U.S.C. 134 or 135 or a decision by a Federal court under 35 U.S.C. 141, 
145, or 146 where allowable claims remain in the application; or
    (4) Issue a patent not later than four months after the date on 
which the issue fee was paid under 35 U.S.C. 151 and all outstanding 
requirements were satisfied.
    (b) Failure to issue a patent within three years of the actual 
filing date of the application. 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 the failure 
of the Office to issue a patent within three years after the actual 
filing date of the application, not including:
    (1) Any time consumed by continued examination of the application 
under 35 U.S.C. 132(b);
    (2) Any time consumed by an interference proceeding under 35 U.S.C. 
135(a);
    (3) Any time consumed by the imposition of a secrecy order under 35 
U.S.C. 181;
    (4) Any time consumed by review by the Board of Patent Appeals and 
Interferences or a Federal court; or
    (5) Any delay in the processing of the application by the Office 
that was requested by the applicant.
    (c) Delays caused by interference proceedings. 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 interference proceedings under 35 U.S.C. 135(a).
    (d) Delays caused by secrecy order. 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 the 
application being placed under a secrecy order under 35 U.S.C. 181.
    (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 pursuant to a decision reversing an adverse 
determination of patentability.
    (f) The provisions of this section and Secs. 1.703 through 1.705 
apply only to original applications, except applications for a design 
patent, filed on or after May 29, 2000, and patents issued on such 
applications.


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

    (a) The period of adjustment under Sec. 1.702(a) is the sum of the 
following periods, to the extent that the periods are not overlapping:
    (1) The number of days, if any, in the period beginning on the date 
fourteen months after the date on which the application was filed under 
35 U.S.C. 111(a) or fulfilled the requirements of 35 U.S.C. 371 and 
ending on the date of mailing of either an action under 35 U.S.C. 132, 
or a notice of allowance under 35 U.S.C. 151, whichever occurs first;
    (2) The number of days, if any, in the period beginning on the date 
four months after the date a reply under Sec. 1.111 was filed and 
ending on the date of mailing of an action under 35 U.S.C. 132, or a 
notice of allowance under 35 U.S.C. 151, whichever occurs first;
    (3) The number of days, if any, in the period beginning on the date 
four months after the date a reply in compliance with Sec. 1.113 was 
filed and ending on the date of mailing of an action under 35 U.S.C. 
132, or a notice of allowance under 35 U.S.C. 151, whichever occurs 
first;
    (4) The number of days, if any, in the period beginning on the date 
four months after the date a notice of appeal to the Board of Patent 
Appeals and Interferences under 35 U.S.C. 134 and Sec. 1.191 was filed 
and ending on the date of mailing of an examiner's answer under 
Sec. 1.193, an action under 35 U.S.C. 132, or a notice of allowance 
under 35 U.S.C. 151, whichever occurs first;
    (5) The number of days, if any, in the period beginning on the date 
four months after the date of a final decision by the Board of Patent 
Appeals and Interferences or by a Federal court in an appeal under 35 
U.S.C. 141 or a civil action under 35 U.S.C. 145 or 146 in an 
application containing allowable claims and ending on the date of 
mailing of either an action under 35 U.S.C. 132 or a notice of 
allowance under 35 U.S.C. 151, whichever occurs first; and
    (6) The number of days, if any, in the period beginning on the date 
four months after the date the issue fee was paid and all outstanding 
requirements were satisfied and ending on the date a patent was issued.
    (b) The period of adjustment under Sec. 1.702(b) is the number of 
days, if any, in the period beginning on the date three years after the 
actual filing date of the application and ending on the date a patent 
was issued, but not including the sum of the following periods:
    (1) The number of days, if any, in the period beginning on the date 
on which a request for continued examination of the application under 
35 U.S.C. 132(b) was filed and ending on the date the patent was 
issued;
    (2)(i) The number of days, if any, in the period beginning on the 
date an interference was declared or redeclared to involve the 
application in the interference and ending on the date that the 
interference was terminated with respect to the application; and
    (ii) The number of days, if any, in the period beginning on the 
date prosecution in the application was suspended by the Office due to 
interference proceedings under 35 U.S.C. 135(a) not involving the 
application and ending on the date of the termination of the 
suspension;
    (3)(i) The number of days, if any, the application was maintained 
in a sealed condition under 35 U.S.C. 181;
    (ii) The number of days, if any, in the period beginning on the 
date of mailing

[[Page 17227]]

of an examiner's answer under Sec. 1.193 in the application under 
secrecy order and ending on the date the secrecy order was removed;
    (iii) The number of days, if any, in the period beginning on the 
date applicant was notified that an interference would be declared but 
for the secrecy order and ending on the date the secrecy order was 
removed; and
    (iv) The number of days, if any, in the period beginning on the 
date of notification under Sec. 5.3(c) of this chapter and ending on 
the date of mailing of the notice of allowance under Sec. 1.311; and,
    (4) The number of days, if any, in the period beginning on the date 
on which a notice of appeal to the Board of Patent Appeals and 
Interferences was filed under 35 U.S.C. 134 and Sec. 1.191 and ending 
on the date of a final decision by the Board of Patent Appeals and 
Interferences or by a Federal court in an appeal under 35 U.S.C. 141 or 
a civil action under 35 U.S.C. 145.
    (c) The period of adjustment under Sec. 1.702(c) is the sum of the 
following periods, to the extent that the periods are not overlapping:
    (1) The number of days, if any, in the period beginning on the date 
an interference was declared or redeclared to involve the application 
in the interference and ending on the date that the interference was 
terminated with respect to the application; and
    (2) The number of days, if any, in the period beginning on the date 
prosecution in the application was suspended by the Office due to 
interference proceedings under 35 U.S.C. 135(a) not involving the 
application and ending on the date of the termination of the 
suspension.
    (d) The period of adjustment under Sec. 1.702(d) is the sum of the 
following periods, to the extent that the periods are not overlapping:
    (1) The number of days, if any, the application was maintained in a 
sealed condition under 35 U.S.C. 181;
    (2) The number of days, if any, in the period beginning on the date 
of mailing of an examiner's answer under Sec. 1.193 in the application 
under secrecy order and ending on the date the secrecy order was 
removed;
    (3) The number of days, if any, in the period beginning on the date 
applicant was notified that an interference would be declared but for 
the secrecy order and ending on the date the secrecy order was removed; 
and
    (4) The number of days, if any, in the period beginning on the date 
of notification under Sec. 5.3(c) of this chapter and ending on the 
date of mailing of the notice of allowance under Sec. 1.311.
    (e) The period of adjustment under Sec. 1.702(e) is the sum of the 
number of days, if any, in the period beginning on the date on which a 
notice of appeal to the Board of Patent Appeals and Interferences was 
filed under 35 U.S.C. 134 and Sec. 1.191 and ending on the date of a 
final decision in favor of the applicant by the Board of Patent Appeals 
and Interferences or by a Federal court in an appeal under 35 U.S.C. 
141 or a civil action under 35 U.S.C. 145.
    (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 
adjustment 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.
    (g) No patent the term of which has been disclaimed beyond a 
specified date shall be adjusted under Sec. 1.702 and this section 
beyond the expiration date specified in the disclaimer.


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

    (a) The period of adjustment of the term of a patent under 
Sec. 1.703(a) through (e) shall be reduced by a period equal to the 
period of time during which the applicant failed to engage in 
reasonable efforts to conclude prosecution (processing or examination) 
of the application.
    (b) With respect to the ground for adjustment set forth in 
Sec. 1.702(a) through (e), and in particular the ground of adjustment 
set forth in Sec. 1.702(b), an applicant shall be deemed to have failed 
to engage in reasonable efforts to conclude processing or examination 
of the application for the cumulative total of any periods of time in 
excess of three months that are taken to reply to any notice or action 
by the Office making any rejection, objection, argument, or other 
request, measuring such three-month period from the date the notice or 
action was mailed or given to the applicant, 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 date three months after the date of 
mailing of the Office communication notifying the applicant of the 
rejection, objection, argument, or other request and ending on the date 
the reply was filed.
    (c) Circumstances that constitute a failure of the applicant to 
engage in reasonable efforts to conclude processing or examination of 
the application also include the following circumstances, which will 
result in the following reduction of the period of adjustment set forth 
in Sec. 1.703 to the extent that the periods are not overlapping:
    (1) Suspension of action under Sec. 1.103 at the applicant's 
request, 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 date a 
request for suspension of action under Sec. 1.103 was filed and ending 
on the date of the termination of the suspension;
    (2) Deferral of issuance of a patent under Sec. 1.314, 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 date a request for 
deferral of issuance of a patent under Sec. 1.314 was filed and ending 
on the date the patent was issued;
    (3) Abandonment of the application or late payment of the issue 
fee, 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 date 
of abandonment or the date after the day the issue fee was due and 
ending on the date of mailing of the decision reviving the application 
or accepting late payment of the issue fee;
    (4) Failure to file a petition to withdraw the holding of 
abandonment or to revive an application within two months from the 
mailing date of a notice of abandonment, 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 date two months from the mailing date of 
a notice of abandonment and ending on the date a petition to withdraw 
the holding of abandonment or to revive the application was filed;
    (5) Conversion of a provisional application under 35 U.S.C. 111(b) 
to a nonprovisional application under 35 U.S.C. 111(a) pursuant to 35 
U.S.C. 111(b)(5), 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 date the application was filed under 35 U.S.C. 111(b) and ending on 
the date a request in compliance with Sec. 1.53(c)(3) to convert the 
provisional application into a nonprovisional application was filed;

[[Page 17228]]

    (6) Failure to file the basic filing fee (Sec. 1.16(a) or (g)), any 
English language translation required by Sec. 1.52(d), or an oath or 
declaration (Sec. 1.63) executed by all of the inventors in an 
application under 35 U.S.C. 111(a), 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 date the application was filed and 
ending on the later of the date the applicant supplied the basic filing 
fee (Sec. 1.16), supplied any English language translation required by 
Sec. 1.52(d), and either supplied an oath or declaration (Sec. 1.63) 
executed in compliance with Sec. 1.64 or, if the oath or declaration 
was not executed by all of the inventors, the earliest of date the 
application was accorded status under Sec. 1.47 or four months after a 
grantable petition under Sec. 1.47 was filed;
    (7) Failure to fulfill the requirements of 35 U.S.C. 371(c) and 
Sec. 1.494 or Sec. 1.495 in an international application, 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 date the application was 
filed under 35 U.S.C. 363 and the later of the date the application 
fulfilled the requirements of 35 U.S.C. 371(c) and Sec. 1.494 or 
Sec. 1.495 or, if the oath or declaration (Sec. 1.497) is not executed 
by all of the inventors, the earliest of date the application was 
accorded status under Sec. 1.47 or four months after a grantable 
petition under Sec. 1.47 was filed;
    (8) Failure to request the national stage of processing in an 
international application if the application fulfills the requirements 
of 35 U.S.C. 371(c) and Sec. 1.494 or Sec. 1.495 before the expiration 
of the applicable time period set forth in Sec. 1.494(b) or 
Sec. 1.495(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 date the application was filed under 35 U.S.C. 363 and ending on 
the earlier of date of expiration of the applicable time period in 
Sec. 1.494(b) or Sec. 1.495(b) or the date on which an express request 
for national stage of processing is filed;
    (9) Failure to file an application with a specification on papers 
in compliance with Sec. 1.52 and having a title and abstract in 
compliance with Sec. 1.72, drawings in compliance with Sec. 1.84 (if 
applicable), and a sequence listing in compliance with Secs. 1.821 
through 1.825 (if applicable), 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 filing date of the application and ending on the date 
the application contains a specification on papers in compliance with 
Sec. 1.52 and having an abstract (Sec. 1.72(b)), drawings in compliance 
with Sec. 1.84 (if applicable), and a sequence listing in compliance 
with Secs. 1.821 through 1.825 (if applicable);
    (10) Submission of a preliminary amendment or other preliminary 
paper less than one month before the mailing of an Office action under 
35 U.S.C. 132 or notice of allowance under 35 U.S.C. 151 that requires 
the mailing of a supplemental Office action or notice of allowance, 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 mailing date of 
the original Office action or notice of allowance and ending on the 
mailing date of the supplemental Office action or notice of allowance;
    (11) Submission of a reply having an omission under Sec. 1.135(c), 
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 date the reply 
having an omission was filed and ending on the date that the omission 
was filed;
    (12) Submission of a supplemental reply or other paper after a 
reply has been filed, 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 date the initial reply was filed and ending on the date that the 
supplemental reply or other such paper was filed;
    (13) Failure to file an appeal brief (and brief fee) in compliance 
with Sec. 1.192 with a notice of appeal to the Board of Patent Appeals 
and Interferences under 35 U.S.C. 134 and Sec. 1.191, 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 date a notice of appeal to the 
Board of Patent Appeals and Interferences under 35 U.S.C. 134 and 
Sec. 1.191 was filed and ending on the day an appeal brief in 
compliance with Sec. 1.192 was filed, or, if no appeal brief under 
Sec. 1.192 is filed, ending on the day an amendment in compliance with 
Sec. 1.113 was filed;
    (14) Submission of an amendment or other paper after a decision by 
the Board of Patent Appeals and Interferences, other than a decision 
designated as containing a new ground of rejection under Sec. 1.196(b) 
or statement under Sec. 1.196(c), or a decision by a Federal court less 
than one month before the mailing of an Office action under 35 U.S.C. 
132 or notice of allowance under 35 U.S.C. 151 that requires the 
mailing of a supplemental Office action or supplemental notice of 
allowance, 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 mailing date of the original Office action or notice of allowance 
and ending on the mailing date of the supplemental Office action or 
notice of allowance;
    (15) Submission 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) The 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) Four months; and
    (16) Further prosecution via a continuing application, in which 
case the period of adjustment set forth in Sec. 1.703 shall not include 
any period that is prior to the actual filing date of the application 
that resulted in the patent.


Sec. 1.705  Patent term adjustment determination.

    (a) The notice of allowance will include notification of any patent 
term adjustment under 35 U.S.C. 154(b).
    (b) Any request for reconsideration of the patent term adjustment 
indicated in the notice of allowance, except as provided in paragraph 
(d) of this section, and any request for reinstatement of all or part 
of the term reduced pursuant to Sec. 1.704(b) must be by way of an 
application for patent term adjustment. An application for patent term 
adjustment under this section must be filed no later than payment of 
the issue fee but may not be filed earlier than the date of mailing of 
the notice of allowance. An application for patent term adjustment 
under this section must be accompanied by:
    (1) The fee set forth in Sec. 1.18(e); and
    (2) A statement of the facts involved, specifying:
    (i) The correct patent term adjustment and the basis or bases under 
Sec. 1.702 for the adjustment;
    (ii) The relevant dates as specified in Sec. 1.703(a) through (e) 
for which an adjustment is sought and the adjustment as specified in 
Sec. 1.703(f) to which the patent is entitled;
    (iii) Whether the patent is subject to a terminal disclaimer and 
any expiration date specified in the terminal disclaimer; and
    (iv)(A) Any circumstances during the prosecution of the application 
resulting in the patent that constitute a failure to engage in 
reasonable efforts to conclude processing or examination of such 
application as set forth in Sec. 1.704; or
    (B) That there were no circumstances constituting a failure to 
engage in

[[Page 17229]]

reasonable efforts to conclude processing or examination of such 
application as set forth in Sec. 1.704.
    (c) Any application for patent term adjustment under this section 
that requests reinstatement of all or part of the term reduced pursuant 
to Sec. 1.704(b) for failing to reply to a rejection, objection, 
argument, or other request within three months of the date of mailing 
of the Office communication notifying the applicant of the rejection, 
objection, argument, or other request must also be accompanied by:
    (1) The fee set forth in Sec. 1.18(f); and
    (2) A showing to the satisfaction of the Director that, in spite of 
all due care, the applicant was unable to reply to the rejection, 
objection, argument, or other request within three months of the date 
of mailing of the Office communication notifying the applicant of the 
rejection, objection, argument, or other request. The Office shall not 
grant any request for reinstatement for more than three additional 
months for each reply beyond three months of the date of mailing of the 
Office communication notifying the applicant of the rejection, 
objection, argument, or other request.
    (d) If the patent is issued on a date other than the projected date 
of issue and this change necessitates a revision of the patent term 
adjustment indicated in the notice of allowance, the patent will 
indicate the revised patent term adjustment. If the patent indicates a 
revised patent term adjustment due to the patent being issued on a date 
other than the projected date of issue, any request for reconsideration 
of the patent term adjustment indicated in the patent must be filed 
within thirty days of the date the patent issued and must comply with 
the requirements of paragraphs (b)(1) and (b)(2) of this section.
    (e) The periods set forth in this section are not extendable.
    (f) No submission or petition on behalf of a third party concerning 
patent term adjustment under 35 U.S.C. 154(b) will be considered by the 
Office. Any such submission or petition will be returned to the third 
party, or otherwise disposed of, at the convenience of the Office.
    7. A undesignated center heading is added to Subpart F before 
Sec. 1.710 to read as follows:
Extension of Patent Term due to Regulatory Review

    Dated: March 24, 2000.
Q. Todd Dickinson,
Assistant Secretary of Commerce and Commissioner of Patents and 
Trademarks.
[FR Doc. 00-7938 Filed 3-30-00; 8:45 am]
BILLING CODE 3510-16-P