[Federal Register Volume 87, Number 88 (Friday, May 6, 2022)]
[Proposed Rules]
[Pages 27043-27048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-09535]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No. PTO-P-2021-0061]
RIN 0651-AD59


Establishing Permanent Electronic Filing for Patent Term 
Extension Applications

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 (USPTO or 
Office) proposes to amend the Rules of Practice in Patent Cases to 
require that patent term extension (PTE) applications, interim PTE 
applications, and any related submissions to the USPTO be submitted 
electronically via the USPTO patent electronic filing system (EFS-Web 
or Patent Center). The proposed rule changes would reduce the 
administrative burden on PTE applicants. They also would further 
advance the USPTO's information technology (IT) strategy to achieve 
complete beginning-to-end electronic processing of patent-related 
submissions, thereby improving administrative efficiency by 
facilitating electronic file management, optimizing workflow processes, 
and reducing processing errors.

DATES: Comments must be received by July 5, 2022 to ensure 
consideration.

ADDRESSES: For reasons of Government efficiency, comments must be 
submitted through the Federal eRulemaking Portal at 
www.regulations.gov. To submit comments via the portal, enter docket 
number PTO-P-2021-0061 on the homepage and click ``Search.'' The site 
will provide a search results page listing all documents associated 
with this docket. Find a reference to this document and click on the 
``Comment Now! '' icon, complete the required fields, and enter or 
attach your comments. Attachments to electronic comments will be 
accepted in Adobe[supreg] portable document format (PDF) or Microsoft 
Word[supreg] format. 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.
    Visit the Federal eRulemaking Portal for additional instructions on 
providing comments via the portal. If electronic submission of, or 
access to, comments is

[[Page 27044]]

not feasible due to a lack of access to a computer and/or the internet, 
please contact the USPTO using the contact information below for 
special instructions.

FOR FURTHER INFORMATION CONTACT: Ali Salimi, Senior Legal Advisor, 
Office of Patent Legal Administration, at 571-272-0909; or Raul Tamayo, 
Senior Legal Advisor, Office of Patent Legal Administration, at 571-
272-7728. You can also send inquiries to <a href="/cdn-cgi/l/email-protection#1d6d7c697873696d6f7c7e69747e785d686e6d6972337a726b"><span class="__cf_email__" data-cfemail="75051401101b0105071416011c161035000605011a5b121a03">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: PTE under 35 U.S.C. 156 enables the owners 
of patents that claim certain human drug products, medical device 
products, animal drug products, veterinary biological products, and 
food or color additive products to restore to the terms of those 
patents some of the time lost while awaiting premarket Government 
approval for the products from a regulatory agency. See, e.g., section 
2750 of the Manual of Patent Examining Procedure (MPEP, Ninth Edition, 
R-10.2019). The USPTO administers 35 U.S.C. 156 in partnership with the 
relevant regulatory agencies (i.e., the Food and Drug Administration 
(FDA) and the United States Department of Agriculture (USDA)). As part 
of its administration, the USPTO sends to the relevant agency a copy of 
any initial submission for PTE that the USPTO receives (i.e., a copy of 
any PTE application under 35 U.S.C. 156(d)(1) and 37 CFR 1.740 or any 
interim PTE application under 35 U.S.C. 156(d)(5) and 37 CFR 1.790).
    Prior to the COVID-19 pandemic, the USPTO prohibited the electronic 
filing of initial submissions for PTE. See section B2 of the Legal 
Framework for Patent Electronic System, available at www.uspto.gov/patents/apply/filing-online/legal-framework-efs-web, and section 
502.05(I)(B)(2) of the MPEP. Requiring initial PTE submissions, which 
often comprise hundreds of pages, to be physically filed in triplicate 
under 37 CFR 1.740(b) was viewed as the most effective way to minimize 
processing errors.
    Due to the workplace changes caused by the COVID-19 pandemic, the 
USPTO waived its prohibition on the electronic filing of initial 
submissions for PTE and the triplicate copy requirements in 37 CFR 
1.740(b) and 1.790(b). See Relief Available to Patentees in View of the 
COVID-19 Outbreak for Submission of Initial Patent Term Extension 
Applications Filed Pursuant to 35 U.S.C. 156, 1475 Off. Gaz. Pat. 
Office 234 (June 23, 2020). The waiver did not impact related follow-on 
submissions to the USPTO, which were already permitted to be filed 
electronically prior to the pandemic.
    Through informal feedback received during the processing of PTE 
applications, stakeholders have thus far communicated unanimous support 
for electronic filing of initial PTE submissions. Additionally, the 
USPTO and its partner agencies have successfully implemented a system 
by which the USPTO electronically transmits a copy of any initial 
submission for PTE to the relevant agency. The new system has not 
caused any processing errors.
    Accordingly, the USPTO is proposing to change its rules of practice 
to require that PTE applications, interim PTE applications, and any 
related submissions to the USPTO be submitted electronically via the 
USPTO patent electronic filing system. The proposed rule changes are 
designed to streamline the filing of PTE applications and related 
documents and minimize paper handling. As has been the case since the 
June 2020 implementation of the electronic filing waiver, the proposed 
rule changes will result in PTE applications being viewable in USPTO 
patent electronic viewing systems (the Patent Application Information 
Retrieval (PAIR) system or Patent Center) immediately upon filing. 
Additionally, the changes would permit the USPTO to more efficiently 
allocate the personnel and physical space it currently deploys for the 
handling of physical copies of PTE submissions.
    If the proposed rule changes are adopted, PTE applicants must use 
the correct document description to ensure that USPTO personnel are 
timely apprised of electronic submissions. ``Patent Term Extension 
Application Under 35 U.S.C. 156'' (Doc Code TERM.REQ) is the correct 
document description for a PTE application under 35 U.S.C. 156(d)(1) 
and 37 CFR 1.740, and ``Interim Patent Term Extension Application Under 
35 U.S.C. 156(d)(5)'' (Doc Code TERM.REQ.ITM) is the correct document 
description for an interim PTE application under 35 U.S.C. 156(d)(5) 
and 37 CFR 1.790. The USPTO has also created the new document 
descriptions ``Interim Patent Term Extension Request Under 35 U.S.C. 
156(e)(2)'' (Doc Code TERM.REQ.E2) for requests for interim extension 
of the patent term under 35 U.S.C. 156(e)(2) and 37 CFR 1.760, and 
``Disclosure Under 37 CFR 1.765 in a Patent Term Extension 
Application'' (Doc Code TERM.DISCL) for disclosures to the USPTO under 
37 CFR 1.765. PTE applicants are reminded that, when multiple PTE 
applications are filed for different patents based on the same 
regulatory review period, it is incumbent upon the PTE applicants to 
inform the USPTO of the various PTE applications, pursuant to 37 CFR 
1.740(a)(13) and 37 CFR 1.765. See also section 2761 of the MPEP.
    In addition, the USPTO has created the new document description 
``Limited POA and/or Change of Address for a Patent Term Extension 
Application'' (Doc Code PTE.POA) for limited powers of attorney and/or 
changes of correspondence address that are filed specifically for PTE 
applications. Although a power of attorney or limited power of attorney 
is not required for a practitioner to prosecute a PTE application 
(practitioners may prosecute PTE applications by acting in a 
representative capacity pursuant to 37 CFR 1.34), the USPTO routinely 
receives limited powers of attorney specifying that the power is 
limited to prosecution of the PTE application. A limited power of 
attorney filed using the document description ``Limited POA and/or 
Change of Address for a Patent Term Extension Application'' (Doc Code 
PTE.POA) will not be processed by the Office of Patent Application 
Processing (OPAP) and will not serve to change an existing power for 
the underlying patent or establish power for the underlying patent.
    As for a change of the correspondence address that is filed 
specifically for a PTE application, the USPTO uses the 37 CFR 
1.740(a)(15) address provided in an initial PTE or interim PTE 
application strictly for communications regarding the PTE application. 
If a PTE applicant subsequently wishes to change the 37 CFR 
1.740(a)(15) address, the document description ``Limited POA and/or 
Change of Address for a Patent Term Extension Application'' (Doc Code 
PTE.POA) should be used for the submission. A change of address filed 
using the document description ``Limited POA and/or Change of Address 
for a Patent Term Extension Application'' (Doc Code PTE.POA) will not 
be processed by the OPAP and will not serve to change the 
correspondence address for the underlying patent. PTE applicants are 
reminded to separately file a change of address with any other relevant 
regulatory agency to timely receive copies of correspondence from that 
agency.
    PTE applicants are strongly encouraged to confirm that they have 
used the correct document description for any PTE submission, 
especially time-sensitive PTE submissions, such as interim PTE 
applications under 35 U.S.C. 156(d)(5) and 37 CFR 1.790. Use of the 
correct document description may be verified by reviewing the EFS

[[Page 27045]]

Acknowledgement Receipt (Doc Code N417) issued for the submission. In 
addition, both the document description and code for a submission may 
be verified in the electronic application file. If a mistake is 
identified, PTE applicants should contact the Patent Electronic 
Business Center at 866-217-9197 or <a href="/cdn-cgi/l/email-protection#3570777675404645415a1b525a43"><span class="__cf_email__" data-cfemail="2267606162575152564d0c454d54">[email protected]</span></a>.
    When electronically filing a PTE or interim PTE application, the 
PTE or interim PTE application, including all exhibits, attachments, or 
appendices, should be submitted as a single file. If the single file 
comprising the application and its exhibits, attachments, or appendices 
exceeds the upload limit of the USPTO patent electronic filing system, 
the file may be split into smaller files to permit uploading, but the 
number of separate files to be uploaded should be minimized. 
Additionally, when splitting a file into smaller files, the order of 
the exhibits, attachments, or appendices as mentioned in the 
application should be maintained, and a single exhibit, attachment, or 
appendix should not be split, if possible. The USPTO has created a new 
document description, ``Continuation of Patent Term Extension 
Application'' (Doc Code PTE.APPENDIX), to be used for any exhibit, 
attachment, or appendix to a PTE or interim PTE application that is 
filed separately from the application.

Discussion of Specific Rules

    The following is a discussion of the proposed amendments to 37 CFR 
part 1.
    Section 1.740: Section 1.740(a)(15) is proposed to be amended to 
require the provision of an email address of the person to whom 
inquiries and correspondence related to the PTE application are to be 
directed. The USPTO has found that the availability of an email address 
facilitates contact with the PTE applicant's representative.
    Section 1.740(b) is proposed to be amended to require that PTE 
applications under Sec.  1.740, and any related submissions to the 
USPTO, be submitted using the USPTO patent electronic filing system in 
accordance with the USPTO patent electronic filing system requirements. 
Submissions to the USPTO related to PTE applications under Sec.  1.740 
include any related follow-on documents that must be submitted to the 
USPTO, such as corrections of informalities under Sec.  1.740(c), 
petitions requesting review of incomplete filings or review of an 
accorded filing date under Sec.  1.741(b), requests for reconsideration 
of notices of final determination and responses to requirements for 
information under Sec.  1.750, requests for 35 U.S.C. 156(e)(2) interim 
extensions under Sec.  1.760, disclosures to the USPTO under Sec.  
1.765, express withdrawals under Sec.  1.770, and replies to requests 
to identify the holder of an approval under Sec.  1.785(d). PTE-related 
submissions to the FDA or the USDA, such as disclosures to the 
Secretary of Health and Human Services or the Secretary of Agriculture 
under Sec.  1.765, should continue to be filed directly with the 
relevant agency. The proposed amendment of Sec.  1.740(b) would remove 
the requirement in the current Sec.  1.740(b) to file each PTE 
application in triplicate.
    Section 1.741: Section 1.741(a) is proposed to be amended to 
provide that the filing date of a PTE application is the date on which 
a complete PTE application is either received in the USPTO via the 
USPTO patent electronic filing system or filed pursuant to the 
procedure set forth in Sec.  1.8(a)(1)(i)(C) and (a)(1)(ii). The 
provision in the current Sec.  1.741(a), which provides that the filing 
date of a PTE application may be the date on which a complete 
application is filed pursuant to the physical mailing or facsimile 
transmission procedures set forth in Sec. Sec.  1.8(a)(1)(i)(A) or (B) 
or 1.10, is proposed to be removed in view of the proposed requirement 
to file PTE applications via the USPTO patent electronic filing system.
    Section 1.770: Section 1.770 is proposed to be amended to remove 
the requirement to file duplicates of express declarations of 
withdrawal of PTE applications. The requirement would no longer be 
needed in view of the proposed requirement to file submissions related 
to PTE applications via the USPTO patent electronic filing system.
    Section 1.790: Section 1.790(a) is proposed to be amended to 
clarify that the referenced paragraphs are paragraphs of 35 U.S.C. 
156(g). Additionally, the time periods in the current Sec.  1.790(a) 
for filing initial and subsequent applications for interim extension 
are proposed to be moved to newly proposed paragraphs (c)(1) and 
(d)(1), respectively, of this section.
    Section 1.790(b) is proposed to be amended to require any 
application for interim extension under this section (i.e., both 
initial and subsequent interim extension applications) to be filed 
using the USPTO patent electronic filing system in accordance with the 
USPTO patent electronic filing system requirements. The provisions in 
the current Sec.  1.790(b) regarding a complete application for interim 
extension are proposed to be moved to newly proposed paragraph (c)(2) 
of this section.
    Section 1.790(c) is proposed to be amended to provide the 
requirements for complete initial applications for interim extension. 
Newly proposed Sec.  1.790(c)(1) contains the time period in the 
current Sec.  1.790(a) for filing an initial interim extension 
application. Newly proposed Sec.  1.790(c)(2) contains the provisions 
in the current Sec.  1.790(b) regarding a complete interim extension 
application. Note that the reference in the current Sec.  1.790(b) to 
Sec.  1.740(a)(16) and (17) is proposed to not be included in newly 
proposed Sec.  1.790(c)(2) to correct an oversight. Paragraphs (a)(16) 
and (17) were removed from Sec.  1.740 on September 8, 2000. Newly 
proposed Sec.  1.790(c)(3) requires a statement that the applicable 
regulatory review period, described in 35 U.S.C. 156(g)(1)(B)(ii), 
(2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), has begun for the 
product. It also requires an identification of the application, 
petition, or notice that caused the applicable regulatory review 
period, described in 35 U.S.C. 156(g)(1)(B)(ii), (2)(B)(ii), 
(3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), to begin. For a human drug, 
antibiotic, or human biological product, it would be the number 
associated with the new drug application or Product License Application 
submitted for the product. For a new animal drug, it would be the 
number associated with the new animal drug application submitted for 
the drug. For a veterinary biological product, it would be the number 
associated with the application for license submitted under the Virus-
Serum-Toxin Act for the product. For a food or color additive, it would 
be the number associated with the petition for product approval 
submitted under the Federal Food, Drug, and Cosmetic Act for the 
additive. For a medical device, it would be the number associated with 
the premarket approval application or notice of completion of a product 
development protocol submitted for the device. The USPTO has 
occasionally received applications for interim extension under 35 
U.S.C. 156(d)(5) and Sec.  1.790 that fail to meet the statutory 
requirement regarding the applicable regulatory review period.
    Newly proposed Sec.  1.790(d) contains the requirements for 
subsequent interim extension applications. Newly proposed Sec.  
1.790(d)(1) contains the time period in the current Sec.  1.790(a) for 
filing each subsequent interim extension application. Newly proposed 
Sec.  1.790(d)(2) contains provisions in the current Sec.  1.790(c) 
regarding the content of each subsequent interim extension application. 
Newly proposed Sec.  1.790(d)(3) contains the requirement

[[Page 27046]]

in the current Sec.  1.790(c) that an application contain a statement 
that the applicable regulatory review period, described in 35 U.S.C. 
156(g)(1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), 
has not been completed.

Rulemaking Requirements

    A. Administrative Procedure Act: The changes proposed in 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 the 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.).
    Accordingly, prior notice and opportunity for public comment for 
the changes proposed in 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), do 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 USPTO has chosen to seek public comment 
before implementing this rule to benefit from the public's input.
    B. Regulatory Flexibility Act: Under the Regulatory Flexibility Act 
(5 U.S.C. 601 et seq.), whenever an agency is required by 5 U.S.C. 553 
(or any other law) to publish a notice of proposed rulemaking, the 
agency must prepare and make available for public comment an Initial 
Regulatory Flexibility Analysis, unless the agency certifies under 5 
U.S.C. 605(b) that the proposed rule, if implemented, will not have a 
significant economic impact on a substantial number of small entities. 
5 U.S.C. 603, 605. For the reasons set forth in this document, the 
Senior Counsel for Regulatory and Legislative Affairs, Office of 
General Law, of the USPTO has certified to the Chief Counsel for 
Advocacy of the Small Business Administration that the proposed rule, 
if implemented, will not have a significant economic impact on a 
substantial number of small entities. See 5 U.S.C. 605(b).
    As a threshold matter, PTE under 35 U.S.C. 156 is only available 
for patents that claim drug products, medical devices, food or color 
additives, or methods of using or manufacturing such products, devices, 
or additives. Approximately 100 PTE applications are filed annually, 
and they are typically filed by non-small entity pharmaceutical and 
medical device companies because of the expense required to develop and 
obtain marketing approval for such inventions.
    The changes proposed in this rule are procedural in nature and are 
not expected to result in significant costs to applicants. The current 
rules of practice permit follow-on documents related to PTE 
applications to be filed electronically. The USPTO estimates that 
approximately 99% of follow-on documents related to PTE applications 
are filed electronically. Accordingly, the proposed rule change 
requiring follow-on documents related to PTE applications to be filed 
electronically should not cause a substantial change in practice or 
result in additional costs to applicants. As for the proposed rule 
change requiring PTE applications to be filed electronically, although 
this would be a change in practice, stakeholders have unanimously 
communicated support for the USPTO's current waiver of the prohibition 
against electronic filing of PTE applications as a result of the COVID-
19 outbreak, and the proposed rule change would not result in any 
additional cost to applicants. Thus, this proposed rule change 
requiring PTE applications to be filed electronically is not expected 
to negatively impact stakeholders' PTE practice.
    Finally, the USPTO patent electronic filing system will allow PTE 
applicants to file PTE documents through their standard web browser 
without downloading special software, changing their documentation 
preparation tools, or altering their workflow processes. PTE applicants 
may create their documents using the tools and processes that they 
already use and then convert those documents into standard PDF files 
for submission through the USPTO patent electronic filing system.
    For these reasons, the proposed changes will not have a significant 
economic impact on a substantial number of small entities.
    C. Executive Order 12866 (Regulatory Planning and Review): This 
proposed rule 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 USPTO has complied with Executive Order 13563 (Jan. 18, 
2011). Specifically, the USPTO has, to the extent feasible and 
applicable: (1) Made a reasoned determination that the benefits justify 
the costs of the proposed rule; (2) tailored the proposed 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 online 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 proposed rule 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 proposed rule 
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 proposed rule is 
not a significant energy action under Executive Order 13211 because the 
proposed rule 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 proposed rule 
meets applicable standards to minimize

[[Page 27047]]

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 proposed 
rule 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 
proposed rule will not effect a taking of private property or otherwise 
have taking implications 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. 801-808), prior to issuing any final rule, the USPTO 
will submit a report containing any final rule resulting from this 
proposed rule and other required information to the U.S. Senate, the 
U.S. House of Representatives, and the Comptroller General of the 
Government Accountability Office. The changes in this proposed rule are 
not expected to result in an annual effect on the economy of $100 
million 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 proposed rule is not a ``major rule'' as defined in 5 
U.S.C. 804(2).
    L. Unfunded Mandates Reform Act of 1995: The proposed 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 (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 (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 of 1969: This proposed rule 
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 of 1995: 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 proposed rule does not contain provisions that involve the use of 
technical standards.
    O. Paperwork Reduction Act of 1995: The Paperwork Reduction Act of 
1995 (44 U.S.C. 3501 et seq.) requires that the USPTO consider the 
impact of paperwork and other information collection burdens imposed on 
the public. In accordance with section 3507(d) of the Paperwork 
Reduction Act of 1995, the paperwork and other information collection 
burdens involved with this proposed rule have already been approved 
under the Office of Management and Budget (OMB) Control Number 0651-
0020 (Patent Term Extension). However, 0651-0020 will be updated to 
reflect a reduction in burden (time) due to the removal of the 
requirement to file PTE applications in paper in triplicate. The USPTO 
estimates that this information collection's annual burden will 
decrease by a total of approximately 51 burden hours. This estimate is 
based on the current OMB-approved burdens (response volumes) associated 
with this information collection, which may fluctuate over time and may 
be different from any forecasts mentioned in other parts of this 
proposed rule.
    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 
has a currently valid OMB control number.
    P. E-Government Act Compliance: The USPTO is committed to 
compliance with the E-Government Act to promote the use of the internet 
and other information technologies, to provide increased opportunities 
for citizen access to Government information and services, and for 
other purposes.

List of Subjects in 37 CFR Part 1

    Administrative practice and procedure, Biologics, Courts, Freedom 
of information, Inventions and patents, Reporting and recordkeeping 
requirements, Small businesses.

    For the reasons set forth in the preamble, the USPTO proposes to 
amend 37 CFR part 1 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. Amend Sec.  1.740 by revising paragraphs (a)(15) and (b) to read as 
follows:


Sec.  1.740  Formal requirements for application for extension of 
patent term; correction of informalities.

    (a) * * *
    (15) The name, address, telephone number, and email address of the 
person to whom inquiries and correspondence related to the application 
for patent term extension are to be directed.
    (b) The application under this section, and any related submissions 
to the Office, must be submitted using the USPTO patent electronic 
filing system in accordance with the USPTO patent electronic filing 
system requirements.
* * * * *
0
3. Amend Sec.  1.741 by revising paragraph (a) introductory text to 
read as follows:


Sec.  1.741  Complete application given a filing date; petition 
procedure.

    (a) The filing date of an application for extension of a patent 
term is the date on which a complete application is either received in 
the Office via the USPTO patent electronic filing system or filed 
pursuant to the procedure set forth in Sec.  1.8(a)(1)(i)(C) and 
(a)(1)(ii). A complete application must include:
* * * * *
0
4. Amend Sec.  1.770 by revising the first sentence to read as follows:


Sec.  1.770  Express withdrawal of application for extension of patent 
term.

    An application for extension of patent term may be expressly 
withdrawn before a determination is made pursuant to Sec.  1.750 by 
filing in the Office a written declaration of withdrawal signed by the 
owner of record of the patent or its agent. * * *
0
5. Revise Sec.  1.790 to read as follows:


Sec.  1.790  Interim extension of patent term under 35 U.S.C. 
156(d)(5).

    (a) An owner of record of a patent or its agent who reasonably 
expects that the applicable regulatory review period, described in 35 
U.S.C. 156(g)(1)(B)(ii), (2)(B)(ii), (3)(B)(ii), (4)(B)(ii), or 
(5)(B)(ii), that began for a product that is the subject of such patent 
may extend beyond the expiration of the patent term in effect may 
submit one or more applications for interim extensions for periods of 
up to one year each. In no event will the interim extensions granted 
under this section be longer than the maximum period of extension to 
which the applicant would be entitled under 35 U.S.C. 156(c).

[[Page 27048]]

    (b) Any application for interim extension under this section must 
be filed using the USPTO patent electronic filing system in accordance 
with the USPTO patent electronic filing system requirements.
    (c) Complete initial applications for interim extension under this 
section must:
    (1) Be filed during the period beginning 6 months and ending 15 
days before the patent term is due to expire, and include a statement 
that the initial application is being submitted within the period and 
an identification of the date of the last day on which the initial 
application could be submitted;
    (2) Include all of the information required for a formal 
application under Sec.  1.740 and a complete application under Sec.  
1.741, except as follows:
    (i) Paragraphs (a)(1), (2), (4), and (6) through (15) of Sec. Sec.  
1.740 and 1.741 shall be read in the context of a product currently 
undergoing regulatory review; and
    (ii) Paragraphs (a)(3) and (5) of Sec.  1.740 are not applicable to 
an application for interim extension under this section; and
    (3) Include a statement that the applicable regulatory review 
period, described in 35 U.S.C. 156(g)(1)(B)(ii), (2)(B)(ii), 
(3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), has begun for the product that 
is the subject of the patent, and identify the application, petition, 
or notice that caused the applicable regulatory review period to begin.
    (d) Each subsequent application for interim extension:
    (1) Must be filed during the period beginning 60 days before and 
ending 30 days before the expiration of the preceding interim extension 
and include a statement that it is being submitted within the period 
and an identification of the date of the last day on which it could be 
submitted;
    (2) May be limited in content to a request for a subsequent interim 
extension along with any materials or information required under 
Sec. Sec.  1.740 and 1.741 that are not present in the preceding 
interim extension application; and
    (3) Must include a statement that the applicable regulatory review 
period, described in 35 U.S.C. 156(g)(1)(B)(ii), (2)(B)(ii), 
(3)(B)(ii), (4)(B)(ii), or (5)(B)(ii), has not been completed.

Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2022-09535 Filed 5-5-22; 8:45 am]
BILLING CODE 3510-16-P


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