[Federal Register Volume 78, Number 62 (Monday, April 1, 2013)]
[Rules and Regulations]
[Pages 19416-19421]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07429]


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

DEPARTMENT OF COMMERCE

United States Patent and Trademark Office

37 CFR Part 1

[Docket No.: PTO-P-2013-0006]
RIN 0651-AC84


Revisions to Patent Term Adjustment

AGENCY: United States Patent and Trademark Office, Commerce.

ACTION: Interim final rule.

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

SUMMARY: The United States Patent and Trademark Office (Office) is 
revising the rules of practice to implement the changes to the patent 
term adjustment provisions in section 1(h) of the Act to correct and 
improve certain provisions of the Leahy-Smith America Invents Act and 
title 35, United States Code (AIA Technical Corrections Act). Section 
1(h) of the AIA Technical Corrections Act revises the date from which 
the fourteen-month patent term adjustment period is measured, and 
clarifies the date from which the three-year patent term adjustment 
period is measured, with respect to international applications filed 
under the Patent Cooperation Treaty. Under section 1(h) of the AIA 
Technical Corrections Act, the fourteen-month patent term adjustment 
period and the three-year patent term adjustment period will be 
measured from the same date: the date on which an application was filed 
under 35 U.S.C. 111(a) in an application under 35 U.S.C. 111; or the 
date of commencement of the national stage under 35 U.S.C. 371 in an 
international application. Section 1(h) of the AIA Technical 
Corrections Act also revises the provisions for notifying applicants of 
patent term adjustment determinations and for requesting 
reconsideration and judicial review of the Office's patent term 
adjustment determinations and decisions.

DATES: Effective date: April 1, 2013.
    Applicability date: The changes to 37 CFR 1.702, 1.703, and 1.705 
in this interim rule apply to any patent granted on or after January 
14, 2013. The change to 37 CFR 1.704 in this interim rule applies to 
any application in which a notice of allowance was mailed on or after 
April 1, 2013.
    Comment deadline date: Written comments must be received on or 
before May 31, 2013.

ADDRESSES: Comments should be sent by electronic mail message over the 
Internet addressed to: AC84.comments@uspto.gov. Comments may also be 
submitted by postal mail addressed to: Mail Stop Comments--Patents, 
Commissioner for Patents, P.O. Box 1450, Alexandria, VA, 22313-1450, 
marked to the attention of Kery A. Fries, Senior Legal Advisor, Office 
of Patent Legal Administration, Office of the Deputy Commissioner for 
Patent Examination Policy.
    Comments may also be sent by electronic mail message over the 
Internet via the Federal eRulemaking Portal. See the Federal 
eRulemaking Portal Web site (http://www.regulations.gov) for additional 
instructions on providing comments via the Federal eRulemaking Portal.
    Although comments may be submitted by postal mail, the Office 
prefers to receive comments by electronic mail message over the 
Internet because sharing comments with the public is more easily 
accomplished. Electronic comments are preferred to be submitted in 
plain text, but also may be submitted in ADOBE[supreg] portable 
document format or MICROSOFT WORD[supreg] format. Comments not 
submitted electronically should be submitted on paper in a format that 
facilitates convenient digital scanning into ADOBE[supreg] portable 
document format.
    The comments will be available for public inspection at the Office 
of the Commissioner for Patents, currently located in Madison East, 
Tenth Floor, 600 Dulany Street, Alexandria, Virginia. Comments also 
will be available for viewing via the Office's Internet Web site 
(http://www.uspto.gov). Because comments will be made available for 
public inspection, information that the submitter does not desire to 
make public, such as an address or phone number, should not be included 
in the comments.

FOR FURTHER INFORMATION CONTACT: Kery A. Fries, Senior Legal Advisor 
((571) 272-7757), Office of Patent Legal Administration, Office of the 
Deputy Commissioner for Patent Examination Policy.

SUPPLEMENTARY INFORMATION: 
    Executive Summary: Purpose: Section 1(h) of the AIA Technical 
Corrections Act revises the patent term adjustment provisions of 35 
U.S.C. 154(b). The AIA Technical Corrections Act revises the date from 
which the fourteen-month period in 35 U.S.C. 154(b)(1)(A)(i)(II), and 
clarifies the date from which the three-year period in 35 U.S.C. 
154(b)(1)(B), are measured with respect to international applications. 
Section 1(h) of the AIA Technical Corrections Act also revises the 
provisions in 35 U.S.C. 154(b)(3) and (b)(4) for notifying applicants 
of patent term adjustment

[[Page 19417]]

determinations and for requesting reconsideration and judicial review 
of the Office's patent term adjustment determinations and decisions.
    Summary of Major Provisions: The Office is revising the rules of 
practice pertaining to patent term adjustment for consistency with the 
change to 35 U.S.C. 154(b)(1)(A)(i)(II) to indicate that the fourteen-
month period is measured from the date of commencement of the national 
stage under 35 U.S.C. 371 in an international application. The change 
to 35 U.S.C. 154(b)(1)(B) does not require a change to the rules of 
practice, as the current rules of practice interpret the phrase 
``actual filing date of the application in the United States'' in 
former 35 U.S.C. 154(b)(1)(B) as meaning the date of commencement of 
the national stage under 35 U.S.C. 371 in an international application.
    The Office is also revising the provisions pertaining to seeking 
reconsideration of a patent term adjustment determination, in light of 
the changes to 35 U.S.C. 154(b)(3) and (b)(4). The Office is continuing 
to provide that any request for reconsideration of the patent term 
adjustment indicated on the patent must be filed within two months from 
the date the patent was granted. The Office is revising this provision 
to indicate that this two-month time period may be extended by an 
additional five months, permitting an applicant to request 
reconsideration of the patent term adjustment indicated on the patent 
as late as seven months after the date the patent was granted.
    Costs and Benefits: This rulemaking is not economically significant 
under Executive Order 12866 (Sept. 30, 1993).
    Background: The AIA Technical Corrections Act was enacted on 
January 14, 2013. See Public Law 112-274, 126 Stat. 2456 (2013). 
Section 1(h) of the AIA Technical Corrections Act revises the patent 
term adjustment provisions of 35 U.S.C. 154(b). See 126 Stat. at 2457.
    Section 1(h)(1)(A) of the AIA Technical Corrections Act amends 35 
U.S.C. 154(b)(1)(A)(i)(II) to change ``the date on which an 
international application fulfilled the requirements of section 371'' 
to ``the date of commencement of the national stage under section 371 
in an international application.'' See id. Under former 35 U.S.C. 
154(b)(1)(A)(i)(II), the fourteen-month period in 35 U.S.C. 
154(b)(1)(A)(i) was measured from ``the date on which an international 
application fulfilled the requirements of section 371 of this title,'' 
and an international application does not fulfill the requirements of 
35 U.S.C. 371 until the applicant files (inter alia) the inventor's 
oath or declaration (35 U.S.C. 371(c)(4) and MPEP Sec.  1893.03(b)). 
See Changes to Implement the Inventor's Oath or Declaration Provisions 
of the Leahy-Smith America Invents Act, 77 FR 48776, 48780 (Aug. 14, 
2012). Thus, under section 1(h)(1)(A) of the AIA Technical Corrections 
Act, the fourteen-month period in 35 U.S.C. 154(b)(1)(A)(i) is measured 
from: (1) The date on which an application was filed under 35 U.S.C. 
111(a); or (2) the date of commencement of the national stage under 35 
U.S.C. 371 in an international application.
    Section 1(h)(1)(B) of the AIA Technical Corrections Act amends 35 
U.S.C. 154(b)(1)(B) to change ``the actual filing date of the 
application in the United States'' to ``the actual filing date of the 
application under section 111(a) in the United States or, in the case 
of an international application, the date of commencement of the 
national stage under section 371 in the international application.'' 
See 126 Stat. at 2457. Thus, under section 1(h)(1)(B) of the AIA 
Technical Corrections Act, the three-year period in 35 U.S.C. 
154(b)(1)(B) is measured from: (1) The actual filing date of the 
application under 35 U.S.C. 111(a) in the United States; or (2) in the 
case of an international application, the date of commencement of the 
national stage under 35 U.S.C. 371 in the international application.
    The change to 35 U.S.C. 154(b)(1)(A)(i)(II) requires a change in 
Office practice, as the date of commencement of the national stage 
under 35 U.S.C. 371 is not always the date on which an international 
application fulfilled the requirements of 35 U.S.C. 371. However, the 
change to 35 U.S.C. 154(b)(1)(B) does not require a change in Office 
practice, because, since the patent term adjustment provisions of 35 
U.S.C. 154(b) were implemented in September of 2000, the Office has 
interpreted the phrase ``actual filing date of the application in the 
United States'' in former 35 U.S.C. 154(b)(1)(B) as the date of 
commencement of the national stage under 35 U.S.C. 371 in an 
international application. See Changes to Implement Patent Term 
Adjustment Under Twenty-Year Patent Term, 65 FR 56365, 56382-84 (Sept. 
18, 2000) (explaining why the phrase ``actual filing date of the 
application in the United States'' in 35 U.S.C. 154(b)(1)(B) must mean 
the date the national stage commenced under 35 U.S.C. 371(b) or (f) in 
the case of an international application). The change to 35 U.S.C. 
154(b)(1)(A)(i)(II) and (b)(1)(B) in section 1(h)(1) of the AIA 
Technical Corrections Act means that the fourteen-month period in 35 
U.S.C. 154(b)(1)(A)(i) and the three-year period in 35 U.S.C. 
154(b)(1)(B) will be measured from the same date: (1) The date on which 
an application was filed under 35 U.S.C. 111(a) in an application under 
35 U.S.C. 111; or (2) the date of commencement of the national stage 
under 35 U.S.C. 371 in an international application.
    Section 1(h)(2) of the AIA Technical Corrections Act amends 35 
U.S.C. 154(b)(3)(B)(i) to change ``shall transmit a notice of that 
[patent term adjustment] determination with the written notice of 
allowance of the application under section 151'' to ``shall transmit a 
notice of that [patent term adjustment] determination no later than the 
date of issuance of the patent.'' See 126 Stat. at 2457. This change 
eliminates the need for the Office to provide an initial patent term 
adjustment determination with the notice of allowance and before the 
patent term adjustment under 35 U.S.C. 154(b)(1)(A)(iv) and 
154(b)(1)(B) is known. See Changes to Implement Patent Term Adjustment 
Under Twenty-Year Patent Term, 65 FR 56365, 56374 (explaining that a 
two-part process is required because the Office is obliged under 35 
U.S.C. 154(b)(3) to provide a patent term adjustment determination 
before the issue date, and thus the patent term adjustment, is known).
    Section 1(h)(3) of the AIA Technical Corrections Act amends 35 
U.S.C. 154(b)(4) to change ``[a]n applicant dissatisfied with a 
determination made by the Director under paragraph (3) shall have 
remedy by a civil action against the Director filed in the United 
States District Court for the Eastern District of Virginia within 180 
days after the grant of the patent'' to ``[a]n applicant dissatisfied 
with the Director's decision on the applicant's request for 
reconsideration under paragraph (3)(B)(ii) shall have exclusive remedy 
by a civil action against the Director filed in the United States 
District Court for the Eastern District of Virginia within 180 days 
after the date of the Director's decision on the applicant's request 
for reconsideration.'' See 126 Stat. at 2457. This change to 35 U.S.C. 
154(b)(4) clarifies that: (1) A civil action under 35 U.S.C. 154(b)(4) 
is not an alternative to requesting reconsideration of a patent term 
adjustment under 35 U.S.C. 154(b)(3), but is the remedy for an 
applicant who is dissatisfied with the Director's decision on the 
applicant's request for reconsideration; and (2) a civil action under 
35 U.S.C. 154(b)(4) is the exclusive remedy for an applicant who is 
dissatisfied with the Director's decision on the applicant's request 
for reconsideration.

[[Page 19418]]

    Section 1(n) of the AIA Technical Corrections Act provides that 
amendments made by the AIA Technical Corrections Act shall take effect 
on January 14, 2013 (the date of enactment of the AIA Technical 
Corrections Act), and shall apply to proceedings commenced on or after 
January 14, 2013. See 126 Stat. at 2459. Section 1(n) of the AIA 
Technical Corrections Act does not limit the applicability of the 
changes in section 1(h) to applications filed on or after January 14, 
2013. Cf. Section 4405(a) of the American Inventors Protection Act of 
1999 (AIPA), Public Law 106-113, 113 Stat. 1501, 1501A-552 through 
1501A-591 (1999) (limiting the applicability of the patent term 
adjustment provisions of the AIPA to applications filed on or after May 
29, 2000 (the date that is six months after the date of the enactment 
of AIPA). Patent term adjustment proceedings are not ``commenced'' 
until the Office notifies the applicant of the Office's patent term 
adjustment under 35 U.S.C. 154(b)(3), which now occurs when the patent 
is granted. Therefore, the changes to 35 U.S.C. 154 in section 1(h) of 
section 1(n) of the AIA Technical Corrections Act apply to any patent 
granted on or after January 14, 2013.

Discussion of Specific Rules

    The following is a discussion of the amendments to Title 37 of the 
Code of Federal Regulations, Part 1.
    Section 1.702: Section 1.702(a)(1) is amended to measure the 
fourteen-month period from the date of commencement of the national 
stage 35 U.S.C. 371(b) or (f) in an international application. Section 
1.702(a)(1)(i) now specifically states that a ground for potential 
patent term adjustment is the failure of the Office to: ``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 the date the 
national stage commenced under 35 U.S.C. 371(b) or (f) in an 
international application.''
    Section 1.702(b) is amended to change the paragraph heading to 
``Three-year pendency.'' No further change to 1.702(b) is necessary, as 
the Office has interpreted the phrase ``actual filing date of the 
application in the United States'' in former 35 U.S.C. 154(b)(1)(B) as 
the date of commencement of the national stage under 35 U.S.C. 371 in 
an international application since the patent term adjustment 
provisions of 35 U.S.C. 154(b) were implemented in September of 2000 
(as discussed previously).
    Section 1.703: Section 1.703(a)(1) is amended to measure its 
fourteen-month period from the date of commencement of the national 
stage 35 U.S.C. 371(b) or (f) in an international application. Section 
1.703(a)(1)(i) now specifically states that the applicable time period 
is: ``The number of days, if any, in the period beginning on the day 
after the date that is fourteen months after the date on which the 
application was filed under 35 U.S.C. 111(a) or the date the national 
stage commenced under 35 U.S.C. 371(b) or (f) in an international 
application 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''.
    No change to Sec.  1.703(b) is necessary, as the Office has 
interpreted the phrase ``actual filing date of the application in the 
United States'' in former 35 U.S.C. 154(b)(1)(B) as the date of 
commencement of the national stage under 35 U.S.C. 371 in an 
international application since the patent term adjustment provisions 
of 35 U.S.C. 154(b) were implemented in September of 2000 (as discussed 
previously).
    Section 1.704: Section 1.704(c) is amended to remove the reference 
to an application for patent term adjustment under Sec.  1.705. Section 
1.705 no longer provides for a request for reconsideration of the 
patent term adjustment indicated in the notice of allowance, as 35 
U.S.C. 154(b)(3) no longer requires a patent term adjustment with the 
notice of allowance.
    35 U.S.C. 154(b)(3)(C) (implemented in Sec.  1.705(c)) provides for 
reinstatement of all or part of the period of adjustment reduced 
pursuant to 35 U.S.C. 154(b)(2)(C) if the applicant makes a showing 
that, in spite of all due care, the applicant was unable to respond 
within the three-month period, but requires that such a showing be made 
``prior to the issuance of the patent.'' Thus, Sec.  1.704(e) continues 
to provide that the submission of a request under Sec.  1.705(c) for 
reinstatement of reduced patent term adjustment will not be considered 
a failure to engage in reasonable efforts to conclude prosecution 
(processing or examination) of the application under Sec.  
1.704(c)(10).
    Section 1.705: Section 1.705(a) provides that the patent will 
include notification of any patent term adjustment under 35 U.S.C. 
154(b). This change is due to the change to 35 U.S.C. 154(b)(3) to no 
longer require notice of a patent term adjustment with the notice of 
allowance. The Office plans to continue to provide an indication of the 
patent term adjustment with the issue notification, but the patent term 
adjustment under 35 U.S.C. 154(b) indicated on the patent is the 
``official'' notification of the Office's patent term adjustment 
determination.
    Section 1.705(b) provides that any request for reconsideration of 
the patent term adjustment indicated on the patent must be by way of an 
application for patent term adjustment filed no later than two months 
from the date the patent was granted, and that this two-month time 
period may be extended under the provisions of Sec.  1.136(a) by five 
months. This provision permits an applicant to request reconsideration 
of the patent term adjustment indicated on the patent as late as seven 
months after the date the patent was granted. Section 1.705(b) no 
longer provides for a request for reconsideration of the Office's 
patent term adjustment determination prior to the grant of a patent.
    The Office has adopted ad hoc procedures for seeking 
reconsideration of the patent term adjustment determination when there 
have been changes (sua sponte or as a result of court decisions) to the 
Office's interpretation of the provisions of 35 U.S.C. 154(b). See 
Revision of Patent Term Adjustment Provisions Relating to Appellate 
Review, 77 FR 49354, 49356 (Aug. 16, 2012), and Interim Procedure for 
Patentees To Request a Recalculation of the Patent Term Adjustment To 
Comply With the Federal Circuit Decision in Wyeth v. Kappos Regarding 
the Overlapping Delay Provision of 35 U.S.C. 154(b)(2)(A), 75 FR 5043, 
5044 (Feb. 1, 2010). These ad hoc procedures were adopted because 
former 35 U.S.C. 154(b)(4) provided a time period for seeking judicial 
review that was not related to the filing of a request for 
reconsideration of the Office's patent term adjustment determination or 
the date of the Office's decision on any request for reconsideration of 
the Office's patent term adjustment determination. In view of the 
changes to 35 U.S.C. 154(b)(3) and 154(b)(4), and to permit patentees 
additional time to determine whether to request reconsideration of the 
Office's patent term adjustment determination, the Office is providing 
in Sec.  1.705(b) that its two-month time period may be extended under 
the provisions of Sec.  1.136(a) (permitting an applicant to request 
reconsideration of the patent term adjustment indicated on the patent 
as late as seven months after the date the patent was granted).
    Section 1.705(c) is amended to provide that any request for 
reinstatement of all or part of the period of adjustment reduced 
pursuant to Sec.  1.704(b) for failing to reply to a rejection, 
objection, argument, or other

[[Page 19419]]

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 be filed prior to the issuance of the 
patent, and that this time period is not extendable. 35 U.S.C. 
154(b)(3)(C) requires that such a showing be made ``prior to the 
issuance of the patent,'' and thus the Office cannot permit the showing 
provided for in 35 U.S.C. 154(b)(3)(C) and Sec.  1.705(c) to be 
submitted with a request for reconsideration of the Office's patent 
term adjustment determination under Sec.  1.705(b).
    The former provisions of Sec. Sec.  1.705(d) and (e) have been 
removed in view of the changes to 1.705(b).

Rulemaking Considerations

    A. Administrative Procedure Act: This rulemaking revises the rules 
of practice in patent cases to implement the changes to the patent term 
adjustment provisions of 35 U.S.C. 154(b) in the AIA Technical 
Corrections Act. The revisions pertaining to 35 U.S.C. 154(b)(1) simply 
revise the provisions of 37 CFR 1.702 and 1.703 for consistency with 
the changes to 35 U.S.C. 154(b)(1). The revisions pertaining to 35 
U.S.C. 154(b)(3) simply revise 37 CFR 1.704 and 1.705 to change 
(extend) the time period for seeking reconsideration of a patent term 
adjustment determination in light of the changes to 35 U.S.C. 
154(b)(3). These changes do not alter the substantive criteria of 
patentability or patent term adjustment. Therefore, these changes 
involve rules of agency practice and procedure and/or interpretive 
rules. See Bachow Commc'ns Inc. v. FCC, 237 F.3d 683, 690 (D.C. Cir. 
2001) (rules governing an application process are procedural under the 
Administrative Procedure Act); Inova Alexandria Hosp. v. Shalala, 244 
F.3d 342, 350 (4th Cir. 2001) (rules for handling appeals were 
procedural where they did not change the substantive standard for 
reviewing claims); National Whistleblower Ctr. v. Nuclear Regulatory 
Comm'n, 208 F.3d 256, 262 (D.C. Cir. 2000) (rules that prescribe a 
timetable for asserting rights are procedural, unless they foreclose an 
effective opportunity to make one's case on the merits) (quoting 
Lamoille Valley R.R. Co. v. ICC, 711 F.2d 295, 328 (D.C. Cir. 1983)); 
and Nat'l Org. of Veterans' Advocates v. Sec'y of Veterans Affairs, 260 
F.3d 1365, 1375 (Fed. Cir. 2001) (rule that clarifies interpretation of 
a statute is interpretive). In addition, good cause exists to make 
these procedural changes without prior notice and opportunity for 
comment and to be effective immediately so as to avoid inconsistency 
between the provisions of 37 CFR 1.702 through 1.705 and 35 U.S.C. 
154(b) as amended by the AIA Technical Corrections Act.
    Accordingly, prior notice and opportunity for public comment are 
not required pursuant to 5 U.S.C. 553(b) or (c) (or any other law) and 
thirty-day advance publication is not required pursuant to 5 U.S.C. 
553(d) (or any other law). See Cooper Techs. Co. v. Dudas, 536 F.3d 
1330, 1336-37 (Fed. Cir. 2008) (stating that 5 U.S.C. 553, and thus 35 
U.S.C. 2(b)(2)(B), does not require notice and comment rulemaking for 
``interpretative rules, general statements of policy, or rules of 
agency organization, procedure, or practice'') (quoting 5 U.S.C. 
553(b)(A)). The Office, however, is publishing these changes as an 
interim rule to allow for public comments because the Office seeks the 
benefit of the public's views on the Office's implementation of the 
changes to 35 U.S.C. 154(b) in the AIA Technical Corrections Act.
    B. Regulatory Flexibility Act: For the reasons set forth herein, 
the Deputy General Counsel for General Law of the United States Patent 
and Trademark Office has certified to the Chief Counsel for Advocacy of 
the Small Business Administration that changes in this rulemaking will 
not have a significant economic impact on a substantial number of small 
entities. See 5 U.S.C. 605(b).
    The changes in this rulemaking: (1) Revise the date from which the 
fourteen-month period in 35 U.S.C. 154(b)(1)(A)(i) is measured in an 
international application for consistency with the change to 35 U.S.C. 
154(b)(1)(A)(i)(II); and (2) revise (extend) the time period for 
seeking reconsideration of the Office's patent term adjustment in view 
of the changes in 35 U.S.C. 154(b)(3) and (b)(4). These changes mirror 
the provisions in the AIA Technical Corrections Act and do not add any 
additional requirements (including information collection requirements) 
or fees for patent applicants or patentees. For these reasons, the 
changes in this rulemaking will not have a significant economic impact 
on a substantial number of small entities.
    C. Executive Order 12866 (Regulatory Planning and Review): This 
rulemaking has been determined to be not significant for purposes of 
Executive Order 12866 (Sept. 30, 1993).
    D. Executive Order 13563 (Improving Regulation and Regulatory 
Review): The Office has complied with Executive Order 13563. 
Specifically, the Office has, to the extent feasible and applicable: 
(1) Made a reasoned determination that the benefits justify the costs 
of the rule; (2) tailored the rule to impose the least burden on 
society consistent with obtaining the regulatory objectives; (3) 
selected a regulatory approach that maximizes net benefits; (4) 
specified performance objectives; (5) identified and assessed available 
alternatives; (6) involved the public in an open exchange of 
information and perspectives among experts in relevant disciplines, 
affected stakeholders in the private sector and the public as a whole, 
and provided on-line access to the rulemaking docket; (7) attempted to 
promote coordination, simplification, and harmonization across 
government agencies and identified goals designed to promote 
innovation; (8) considered approaches that reduce burdens and maintain 
flexibility and freedom of choice for the public; and (9) ensured the 
objectivity of scientific and technological information and processes.
    E. Executive Order 13132 (Federalism): This rulemaking does not 
contain policies with federalism implications sufficient to warrant 
preparation of a Federalism Assessment under Executive Order 13132 
(Aug. 4, 1999).
    F. Executive Order 13175 (Tribal Consultation): This rulemaking 
will not: (1) Have substantial direct effects on one or more Indian 
tribes; (2) impose substantial direct compliance costs on Indian tribal 
governments; or (3) preempt tribal law. Therefore, a tribal summary 
impact statement is not required under Executive Order 13175 (Nov. 6, 
2000).
    G. Executive Order 13211 (Energy Effects): This rulemaking is not a 
significant energy action under Executive Order 13211 because this 
rulemaking is not likely to have a significant adverse effect on the 
supply, distribution, or use of energy. Therefore, a Statement of 
Energy Effects is not required under Executive Order 13211 (May 18, 
2001).
    H. Executive Order 12988 (Civil Justice Reform): This rulemaking 
meets applicable standards to minimize litigation, eliminate ambiguity, 
and reduce burden as set forth in sections 3(a) and 3(b)(2) of 
Executive Order 12988 (Feb. 5, 1996).
    I. Executive Order 13045 (Protection of Children): This rulemaking 
does not concern an environmental risk to health or safety that may 
disproportionately affect children under Executive Order 13045 (Apr. 
21, 1997).
    J. Executive Order 12630 (Taking of Private Property): This 
rulemaking will not effect a taking of private property or otherwise 
have taking implications

[[Page 19420]]

under Executive Order 12630 (Mar. 15, 1988).
    K. Congressional Review Act: Under the Congressional Review Act 
provisions of the Small Business Regulatory Enforcement Fairness Act of 
1996 (5 U.S.C. 801 et seq.), the United States Patent and Trademark 
Office will submit a report containing this interim rule and other 
required information to the United States Senate, the United States 
House of Representatives, and the Comptroller General of the Government 
Accountability Office. The changes in this rulemaking will not result 
in an annual effect on the economy of 100 million dollars or more, a 
major increase in costs or prices, or significant adverse effects on 
competition, employment, investment, productivity, innovation, or the 
ability of United States-based enterprises to compete with foreign-
based enterprises in domestic and export markets. Therefore, this 
rulemaking is not a ``major rule'' as defined in 5 U.S.C. 804(2).
    L. Unfunded Mandates Reform Act of 1995: The changes set forth in 
this rulemaking do not involve a Federal intergovernmental mandate that 
will result in the expenditure by State, local, and tribal governments, 
in the aggregate, of 100 million dollars (as adjusted) or more in any 
one year, or a Federal private sector mandate that will result in the 
expenditure by the private sector of 100 million dollars (as adjusted) 
or more in any one year, and will not significantly or uniquely affect 
small governments. Therefore, no actions are necessary under the 
provisions of the Unfunded Mandates Reform Act of 1995. See 2 U.S.C. 
1501 et seq.
    M. National Environmental Policy Act: This rulemaking will not have 
any effect on the quality of the environment and is thus categorically 
excluded from review under the National Environmental Policy Act of 
1969. See 42 U.S.C. 4321 et seq.
    N. National Technology Transfer and Advancement Act: The 
requirements of section 12(d) of the National Technology Transfer and 
Advancement Act of 1995 (15 U.S.C. 272 note) are not applicable because 
this rulemaking does not contain provisions which involve the use of 
technical standards.
    O. Paperwork Reduction Act: The Paperwork Reduction Act of 1995 (44 
U.S.C. 3501 et seq.) requires that the Office consider the impact of 
paperwork and other information collection burdens imposed on the 
public. The rules of practice pertaining to patent term adjustment and 
extension have been reviewed and approved by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501 et seq.) under OMB control number 0651-0020. The changes in this 
rulemaking: (1) Revise the date from which the fourteen-month period in 
35 U.S.C. 154(b)(1)(A)(i) is measured in an international application 
for consistency with the change to 35 U.S.C. 154(b)(1)(A)(i)(II); and 
(2) revise (extend) the time period for seeking reconsideration of the 
Office's patent term adjustment in view of the changes in 35 U.S.C. 
154(b)(3) and (b)(4). This rulemaking does not add any additional 
requirements (including information collection requirements) or fees 
for patent applicants or patentees. Therefore, the Office is not 
resubmitting information collection packages to OMB for its review and 
approval because the changes in this rulemaking do not affect the 
information collection requirements associated with the information 
collections approved under OMB control number 0651-0020 or any other 
information collections.
    Notwithstanding any other provision of law, no person is required 
to respond to nor shall any person be subject to a penalty for failure 
to comply with a collection of information subject to the requirements 
of the Paperwork Reduction Act unless that collection of information 
displays a currently valid OMB control number.

List of Subjects in 37 CFR Part 1

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

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

PART 1--RULES OF PRACTICE IN PATENT CASES

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

    Authority: 35 U.S.C. 2(b)(2).


0
2. Section 1.702 is amended by revising paragraph (a)(1) and the 
heading of paragraph (b) 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) * * *
    (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 the date the national stage commenced under 35 U.S.C. 371(b) 
or (f) in an international application;
* * * * *
    (b) Three-year pendency. * * *
* * * * *

0
3. Section 1.703 is amended by revising paragraph (a)(1) to read as 
follows:


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

    (a) * * *
    (1) The number of days, if any, in the period beginning on the day 
after the date that is fourteen months after the date on which the 
application was filed under 35 U.S.C. 111(a) or the date the national 
stage commenced under 35 U.S.C. 371(b) or (f) in an international 
application 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;
* * * * *

0
4. Section 1.704 is amended by revising paragraph (e) to read as 
follows:


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

* * * * *
    (e) The submission of a request under Sec.  1.705(c) for 
reinstatement of reduced patent term adjustment will not be considered 
a failure to engage in reasonable efforts to conclude prosecution 
(processing or examination) of the application under paragraph (c)(10) 
of this section.


0
5. Section 1.705 is amended by removing paragraphs (d) and (e), 
redesignating paragraph (f) as paragraph (d), and revising paragraph 
(a), the introductory text of paragraph (b), and the introductory text 
of paragraph (c) to read as follows:


Sec.  1.705  Patent term adjustment determination.

    (a) The patent 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 on the patent must be by way of an application for patent 
term adjustment filed no later than two months from the date the patent 
was granted. This two-month time period may be extended under the 
provisions of Sec.  1.136(a). An application for patent term adjustment 
under this section must be accompanied by:
* * * * *
    (c) Any request for reinstatement of all or part of the period of 
adjustment

[[Page 19421]]

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 be filed prior to 
the issuance of the patent. This time period is not extendable. Any 
request for reinstatement of all or part of the period of adjustment 
reduced pursuant to Sec.  1.704(b) under this paragraph must also be 
accompanied by:
* * * * *

    Date: March 25, 2013.
Teresa Stanek Rea,
Acting Under Secretary of Commerce for Intellectual Property and Acting 
Director of the United States Patent and Trademark Office.
[FR Doc. 2013-07429 Filed 3-29-13; 8:45 am]
BILLING CODE 3510-16-P