[Federal Register Volume 84, Number 193 (Friday, October 4, 2019)]
[Proposed Rules]
[Pages 53090-53094]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-21271]



[[Page 53090]]

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DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No. PTO-P-2019-0019]
RIN 0651-AD38


Patent Term Adjustment Reductions in View of the Federal Circuit 
Decision in Supernus Pharm., Inc. v. Iancu

AGENCY: United States Patent and Trademark Office, Department of 
Commerce.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The United States Patent and Trademark Office (Office) is 
proposing to revise the rules of practice pertaining to patent term 
adjustment in view of the decision by the U.S. Court of Appeals for the 
Federal Circuit (Federal Circuit) in Supernus Pharm., Inc. v. Iancu 
(Supernus). The Federal Circuit in Supernus held that a reduction of 
patent term adjustment must be equal to the period of time during which 
the applicant failed to engage in reasonable efforts to conclude 
prosecution of the application. The Office is proposing to revise the 
provisions pertaining to reduction of patent term adjustment for 
alignment with the Federal Circuit decision in Supernus.

DATES: Written comments must be received on or before December 3, 2019.

ADDRESSES: Comments should be sent by electronic mail message over the 
internet addressed to: [email protected]. Comments also may 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 Fries, Senior Legal Advisor, Office of 
Patent Legal Administration, Office of the Deputy Commissioner for 
Patent Examination Policy.
    Comments further may be sent by electronic mail message over the 
internet via the Federal eRulemaking Portal. See the Federal 
eRulemaking Portal website (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 submitted in plain text are 
preferred, but 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.
    Comments will be available for viewing via the Office's internet 
website (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 Fries, Senior Legal Advisor, 
Office of Patent Legal Administration, Office of the Deputy 
Commissioner for Patent Examination Policy, at telephone number 571-
272-7757.

SUPPLEMENTARY INFORMATION: 
    Executive Summary: Purpose: The Office is proposing to revise the 
rules of practice pertaining to the patent term adjustment provisions 
of 35 U.S.C. 154(b) in view of the decision by the Federal Circuit in 
Supernus Pharm., Inc. v. Iancu, 913 F.3d 1351 (Fed. Cir. 2019). The 
Federal Circuit in Supernus held that a reduction of patent term 
adjustment under 35 U.S.C. 154(b)(2)(C) must be equal to the period of 
time during which the applicant failed to engage in reasonable efforts 
to conclude prosecution of the application. The regulations pertaining 
to a reduction of patent term adjustment due to a failure of an 
applicant to engage in reasonable efforts to conclude processing or 
examination of an application are set forth in 37 CFR 1.704. Several 
provisions in 37 CFR 1.704 specify a period of reduction corresponding 
to the consequences to the Office of applicant's failure to engage in 
reasonable efforts to conclude prosecution i.e., 37 CFR 1.703(c)(2), 
(c)(3), (c)(6), (c)(9), and (c)(10) rather than ``the period from the 
beginning to the end of the applicant's failure to engage in reasonable 
efforts to conclude prosecution'' as provided for in Supernus. 913 F.3d 
at 1359. Therefore, the Office is proposing to revise these provisions 
of 37 CFR 1.704 for consistency with the Federal Circuit's decision in 
Supernus.
    Summary of Major Provisions: This rulemaking pertains to the patent 
term adjustment regulations establishing the circumstances that 
constitute a failure of an applicant to engage in reasonable efforts to 
conclude processing or examination of an application and resulting 
reduction of any patent term adjustment (37 CFR 1.704). This rulemaking 
specifically proposes to revise the period of reduction of patent term 
adjustment in the provisions of 37 CFR 1.704 pertaining to deferral of 
issuance of a patent (37 CFR 1.704(c)(2)), abandonment of an 
application (37 CFR 1.704(c)(3)), submission of a preliminary amendment 
(37 CFR 1.704(c)(6)), submission of papers after a decision by the 
Patent Trial and Appeal Board or by a Federal court (37 CFR 
1.704(c)(9)), and submission of papers after a notice of allowance 
under 35 U.S.C. 151 (37 CFR 1.704(c)(10)) to specify a period of 
reduction corresponding to ``the period from the beginning to the end 
of the applicant's failure to engage in reasonable efforts to conclude 
prosecution'' (rather than corresponding to the consequences to the 
Office of applicant's failure to engage in reasonable efforts to 
conclude prosecution) for consistency with the Federal Circuit's 
decision in Supernus. 913 F.3d at 1359.
    Costs and Benefits: This rulemaking is not economically significant 
under Executive Order 12866 (Sept. 30, 1993).
    Background: The American Inventors Protection Act of 1999 or AIPA 
(Pub. L. 106-113, 113 Stat. 1501, 1501A-552 through 1501A-591 (1999)) 
amended 35 U.S.C. 154(b) to provide for patent term adjustment if 
issuance of the patent is delayed due to one or more of the enumerated 
administrative delays listed in 35 U.S.C. 154(b)(1). Generally, under 
the patent term adjustment provisions of 35 U.S.C. 154(b) as amended by 
the AIPA, an applicant is entitled to patent term adjustment for the 
following reasons: (1) If the Office fails to take certain actions 
during the examination and issue process within specified time frames 
(35 U.S.C. 154(b)(1)(A)) (known as ``A'' delays); (2) if 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)) (known as ``B'' delays); and 
(3) for delays due to interference (and now derivation), secrecy order, 
or successful appellate review (35 U.S.C. 154(b)(1)(C)) (known as ``C'' 
delays). See 35 U.S.C. 154(b)(1). The AIPA, however, sets forth a 
number of conditions and limitations on any patent term adjustment 
accrued under 35 U.S.C. 154(b)(1). See 35 U.S.C. 154(b)(2). 35 U.S.C. 
154(b)(2)(C) sets forth one such limitation, providing, in part, that 
``[t]he period of adjustment of the term of a patent 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 of the application'' and that ``[t]he Director 
shall prescribe regulations establishing the circumstances that 
constitute a failure of

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an applicant to engage in reasonable efforts to conclude processing or 
examination of an application.'' 35 U.S.C. 154(b)(2)(C)(i) and (iii). 
The Office implemented the AIPA patent term adjustment provisions of 35 
U.S.C. 154(b), including setting forth circumstances that constitute a 
failure of an applicant to engage in reasonable efforts to conclude 
processing or examination of an application and resulting in a 
reduction of any patent term adjustment, in a final rule published in 
September of 2000. See Changes to Implement Patent Term Adjustment 
Under Twenty-Year Patent Term, 65 FR 56365 (Sept. 18, 2000) (AIPA 
patent term adjustment final rule). The regulations establishing the 
circumstances that constitute a failure of an applicant to engage in 
reasonable efforts to conclude processing or examination of an 
application and resulting reduction of any patent term adjustment are 
set forth in 37 CFR 1.704.
    In January 2019, the Federal Circuit issued a decision in Supernus 
pertaining to the patent term adjustment provisions of 35 U.S.C. 
154(b)(2)(C). The Federal Circuit confirmed that 37 CFR 1.704(c)(8) `` 
`is a reasonable interpretation of the [patent term adjustment] 
statute' insofar as it includes `not only applicant conduct or behavior 
that result in actual delay, but also those having the potential to 
result in delay irrespective of whether such delay actually occurred.' 
'' Supernus, 913 F.3d at 1356 (quoting Gilead Scis., Inc. v. Lee, 778 
F.3d 1341, 1349-50 (Fed. Cir. 2015)). The Federal Circuit, however, 
held that the Office may not reduce patent term adjustment by a period 
that exceeds the ``time during which the applicant failed to engage in 
reasonable efforts'' to conclude prosecution, specifically stating that 
``[o]n the basis of the plain language of [35 U.S.C. 154(b)(2)(C)(i),] 
the USPTO may not count as applicant delay a period of time during 
which there was no action that the applicant could take to conclude 
prosecution of the patent.'' Id. at 1358. The Federal Circuit 
specifically stated that--

    Thus, the statutory period of PTA reduction must be the same 
number of days as the period from the beginning to the end of the 
applicant's failure to engage in reasonable efforts to conclude 
prosecution. PTA cannot be reduced by a period of time during which 
there is no identifiable effort in which the applicant could have 
engaged to conclude prosecution because such time would not be 
``equal to'' and would instead exceed the time during which an 
applicant failed to engage in reasonable efforts.

Id. at 1359.

    37 CFR 1.704(c)(1) through (c)(14) set forth: (1) The exemplary 
circumstances prescribed by the Office ``that constitute a failure of 
an applicant to engage in reasonable efforts to conclude processing or 
examination of an application'' pursuant to 35 U.S.C. 154(b)(2)(C)(iii) 
and (2) resulting period of reduction of any patent term adjustment. 
The Federal Circuit decision in Supernus involved a reduction to patent 
term adjustment under the provisions of 37 CFR 1.704(c)(8). The period 
of reduction of patent term adjustment in 37 CFR 1.704(c)(8) is as 
follows: ``the number of days, if any, beginning on the day after the 
date the initial reply was filed and ending on the date that the 
supplemental reply or other such paper was filed.'' 37 CFR 1.704(c)(8). 
This period corresponds to ``the period from the beginning to the end 
of the applicant's failure to engage in reasonable efforts to conclude 
prosecution,'' except in the rare situation in which such period 
includes ``a period of time during which there is no identifiable 
effort in which the applicant could have engaged to conclude 
prosecution.'' Supernus, 913 F.3d at 1359. The Office published a 
notice in May of 2019 setting out its implementation of Supernus with 
respect to the provisions of 37 CFR 1.704(c)(8) or other provision of 
37 CFR 1.704(c) that includes ``a period of time during which there is 
no identifiable effort in which the applicant could have engaged to 
conclude prosecution.'' See Patent Term Adjustment Procedures in View 
of the Federal Circuit Decision in Supernus Pharm., Inc. v. Iancu, 84 
FR 20343 (May 9, 2019).
    While the Federal Circuit decision in Supernus involved 37 CFR 
1.704(c)(8), there are several provisions in 37 CFR 1.704(c)(1) through 
(c)(14) whose period of reduction corresponds to or includes the 
consequences to the Office of applicant's failure to engage in 
reasonable efforts to conclude prosecution, rather than ``the period 
from the beginning to the end of the applicant's failure to engage in 
reasonable efforts to conclude prosecution.'' Supernus, 913 F.3d at 
1359. Therefore, the Office is proposing changes to 37 CFR 1.704 to 
revise the periods of reduction of patent term adjustment in 37 CFR 
1.704(c) for consistency with the Federal Circuit's decision in 
Supernus.

Discussion of Specific Rules

    The following is a discussion of amendments to title 37 of the Code 
of Federal Regulations, part 1:
    Section 1.704(c)(2) is proposed to be amended to change ``the date 
the patent was issued'' to ``the earlier of the date a request to 
terminate the deferral was filed or the date the patent was issued.'' 
The period of reduction of patent term adjustment in Sec.  1.704(c)(2) 
would be as follows: ``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 earlier of the date a request to terminate 
the deferral was filed or the date the patent was issued.''
    Section 1.704(c)(3) is proposed to be amended to change ``the 
earlier of: (i) The date of mailing of the decision reviving the 
application or accepting late payment of the issue fee; or (ii) The 
date that is four months after the date the grantable petition to 
revive the application or accept late payment of the issue fee was 
filed'' to ``the date the grantable petition to revive the application 
or accept late payment of the issue fee was filed.'' The period of 
reduction of patent term adjustment in Sec.  1.704(c)(3) would be as 
follows: ``the number of days, if any, beginning on the date of 
abandonment or the date after the date the issue fee was due and ending 
on the date the grantable petition to revive the application or accept 
late payment of the issue fee was filed.''
    Section 1.704(c)(6) is proposed to be amended to change ``the 
lesser of: (i) The number of days, if any, beginning on the day after 
the mailing date of the original Office action or notice of allowance 
and ending on the date of mailing of the supplemental Office action or 
notice of allowance; or (ii) Four months'' to ``the number of days, if 
any, beginning on the day after the date that is eight months from 
either the date on which the application was filed under 35 U.S.C. 
111(a) or the date of commencement of the national stage under 35 
U.S.C. 371(b) or (f) in an international application and ending on the 
date the preliminary amendment or other preliminary paper was filed.'' 
See Changes to Implement the Patent Law Treaty, 78 FR 62367, 62385 
(Oct. 21, 2013) (an application is expected to be in condition for 
examination no later than eight months from its filing date (or date of 
commencement of the national stage in an international application)). 
The period of reduction of patent term adjustment in Sec.  1.704(c)(6) 
would be as follows: ``the number of days, if any, beginning on the day 
after the date that is eight months from either the date on which the 
application was filed under 35 U.S.C. 111(a) or the date of 
commencement of the national stage under 35 U.S.C. 371(b) or (f) in an 
international application and ending on

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the date the preliminary amendment or other preliminary paper was 
filed.''
    Section 1.704(c)(9) is proposed to be amended to change ``the 
lesser of: (i) The number of days, if any, beginning on the day after 
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; or (ii) Four months'' to ``the number of days, if 
any, beginning on the day after the date of the decision by the Patent 
Trial and Appeal Board or by a Federal court and ending on date the 
amendment or other paper was filed.'' The period of reduction of patent 
term adjustment in Sec.  1.704(c)(9) would be as follows: ``the number 
of days, if any, beginning on the day after the date of the decision by 
the Patent Trial and Appeal Board or by a Federal court and ending on 
date the amendment or other paper was filed.''
    Section 1.704(c)(10) is proposed to be amended to change ``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'' 
to ``the number of days, if any, beginning on the day after the mailing 
date of the notice of allowance under 35 U.S.C. 151 and ending on the 
date the amendment under Sec.  1.312 or other paper was filed.'' The 
period of reduction of patent term adjustment in Sec.  1.704(c)(10) 
would be as follows: ``the number of days, if any, beginning on the day 
after the mailing date of the notice of allowance under 35 U.S.C. 151 
and ending on the date the amendment under Sec.  1.312 or other paper 
was filed.''

Rulemaking Considerations

    A. Administrative Procedure Act: The changes proposed by this 
rulemaking involve rules of agency practice and procedure, and/or 
interpretive rules. See Perez v. Mortg. Bankers Ass'n, 135 S. Ct. 1199, 
1204 (2015) (Interpretive rules ``advise the public of the agency's 
construction of the statutes and rules which it administers.'' 
(citation and internal quotation marks omitted)); 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.); 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.). Specifically, this rulemaking proposes to revise 
Office rules that interpret certain statutory provisions pertaining to 
patent term adjustment. The proposed revisions specify a period of 
reduction corresponding to ``the period from the beginning to the end 
of the applicant's failure to engage in reasonable efforts to conclude 
prosecution'' (rather than to the consequences to the Office of 
applicant's failure to engage in reasonable efforts to conclude 
prosecution) for consistency with the Federal Circuit's decision in 
Supernus. 913 F.3d at 1359.
    Accordingly, prior notice and opportunity for public comment for 
the changes proposed by this rulemaking are not required pursuant to 5 
U.S.C. 553(b) or (c), or any other law. See Perez, 135 S. Ct. at 1206 
(Notice-and-comment procedures are required neither when an agency 
``issue[s] an initial interpretive rule'' nor ``when it amends or 
repeals that interpretive rule.''); 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))). However, the Office has chosen to seek public 
comment before implementing the rule to benefit from the public's 
input.
    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 proposed in this notice 
will not have a significant economic impact on a substantial number of 
small entities. See 5 U.S.C. 605(b).
    This rulemaking does not propose to impose any additional 
requirements or fees on applicants. This rulemaking also does not 
propose to change the circumstances defined as constituting a failure 
of an applicant to engage in reasonable efforts to conclude processing 
or examination of an application (35 U.S.C. 154(b)(2)(C)(iii)). This 
rulemaking implements the Federal Circuit's ruling on the provisions of 
35 U.S.C. 154(b)(2)(C)(i) in Supernus to reflect the applicable period 
of reduction in the event that there is a failure of an applicant to 
engage in reasonable efforts to conclude processing or examination. 
This rulemaking specifically proposes to revise the period of reduction 
of patent term adjustment in the provisions of 37 CFR 1.704 pertaining 
to deferral of issuance of a patent (37 CFR 1.704(c)(2)), abandonment 
of an application (37 CFR 1.704(c)(3)), submission of a preliminary 
amendment (37 CFR 1.704(c)(6)), submission of papers after a decision 
by the Patent Trial and Appeal Board or by a Federal court (37 CFR 
1.704(c)(9)), and submission of papers after a notice of allowance 
under 35 U.S.C. 151 (37 CFR 1.704(c)(10)) to specify a period of 
reduction corresponding to ``the period from the beginning to the end 
of the applicant's failure to engage in reasonable efforts to conclude 
prosecution'' (rather than to the consequences to the Office of 
applicant's failure to engage in reasonable efforts to conclude 
prosecution) for consistency with the Federal Circuit's decision in 
Supernus. 913 F.3d at 1359. The changes proposed in this rulemaking 
will not have a significant economic impact on a substantial number of 
small entities because applicants are not entitled to patent term 
adjustment that have not been reduced by a period equal to the period 
of the applicant's failure to engage in reasonable efforts to conclude 
processing or examination (35 U.S.C. 154(b)(2)(C)(i) and 37 CFR 
1.704(a)), and because applicants may avoid adverse patent term 
adjustment consequences by refraining from actions or inactions defined 
as constituting a failure of an applicant to engage in reasonable 
efforts to conclude processing or examination. For the foregoing 
reasons, the changes proposed in this notice 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 (Jan. 18, 
2011). 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-

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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 13771 (Reducing Regulation and Controlling 
Regulatory Costs): This proposed rule is not expected to be an 
Executive Order 13771 (Jan. 30, 2017) regulatory action because this 
proposed rule is not significant under Executive Order 12866 (Sept. 30, 
1993).
    F. 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).
    G. 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).
    H. 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).
    I. Executive Order 13783 (Promoting Energy Independence and 
Economic Growth): This rulemaking does not potentially burden the 
development or use of domestically produced energy resources, with 
particular attention to oil, natural gas, coal, and nuclear energy 
resources under Executive Order 13783 (Mar. 28, 2017).
    J. Executive Order 13772 (Core Principles for Regulating the United 
States Financial System): This rulemaking does not involve regulation 
of the United States financial system under Executive Order 13772 (Feb. 
3, 2017).
    K. 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).
    L. 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).
    M. Executive Order 12630 (Taking of Private Property): This 
rulemaking will not effect a taking of private property or otherwise 
have taking implications under Executive Order 12630 (Mar. 15, 1988).
    N. Congressional Review Act: Under the Congressional Review Act 
provisions of the Small Business Regulatory Enforcement Fairness Act of 
1996 (5 U.S.C. 801-808), the United States Patent and Trademark Office 
will submit a report containing any final rule resulting from this 
rulemaking and other required information to the U.S. Senate, the U.S. 
House of Representatives, and the Comptroller General of the Government 
Accountability Office.
    O. 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.
    P. 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.
    Q. 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.
    R. 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.
    This rulemaking does not impose 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, Biologics, 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 
proposed to be 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), unless otherwise noted.

0
2. Section 1.704 is amended by revising paragraphs (c)(2), (3), (6), 
(9) and (c)(10) to read as follows:


Sec.  1.704  Reduction of Period of Adjustment of Patent Term.

* * * * *
    (c) * * *
    (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 earlier of the date a request to terminate the deferral was 
filed or 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 date the issue fee was due and 
ending on the date the grantable petition to revive the application or 
accept late payment of the issue fee was filed;
* * * * *

[[Page 53094]]

    (6) 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 day after the 
date that is eight months from either the date on which the application 
was filed under 35 U.S.C. 111(a) or the date of commencement of the 
national stage under 35 U.S.C. 371(b) or (f) in an international 
application and ending on the date the preliminary amendment or other 
preliminary paper was filed;
* * * * *
    (9) Submission of an amendment or other paper after a decision by 
the Patent Trial and Appeal Board, other than a decision designated as 
containing a new ground of rejection under Sec.  41.50(b) of this title 
or statement under Sec.  41.50(c) of this title, 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 day after the date of the decision by 
the Patent Trial and Appeal Board or by a Federal court and ending on 
date the amendment or other paper was filed;
    (10) Submission of an amendment under Sec.  1.312 or other paper, 
other than a request for continued examination in compliance with Sec.  
1.114, 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 number of days, if any, beginning on the day after the mailing 
date of the notice of allowance under 35 U.S.C. 151 and ending on the 
date the amendment under Sec.  1.312 or other paper was filed;
* * * * *

Andrei Iancu,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2019-21271 Filed 10-3-19; 8:45 am]
 BILLING CODE 3510-16-P