[Federal Register Volume 88, Number 41 (Thursday, March 2, 2023)]
[Rules and Regulations]
[Pages 13028-13033]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04162]


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

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: Final rule.

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

SUMMARY: To further advance the United States Patent and Trademark 
Office's (USPTO or Office) information technology strategy of achieving 
complete beginning-to-end electronic processing of patent-related 
submissions, the USPTO is revising 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 (Patent 
Center or EFS-Web). The rule changes reduce the administrative burden 
on PTE applicants and improve administrative efficiency by facilitating 
electronic file management, optimizing workflow processes, and reducing 
processing errors.

DATES: This rule is effective on May 1, 2023.

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 [email protected].

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, or 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, 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.
    The USPTO is revising its rules of practice to require that PTE 
applications, interim PTE applications,

[[Page 13029]]

and any related submissions to the USPTO be submitted electronically 
via the USPTO patent electronic filing system. The 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, PTE applications will 
be viewable in the USPTO patent electronic viewing systems (Patent 
Center or the private Patent Application Information Retrieval (PAIR) 
system) immediately upon filing. The changes permit the USPTO to more 
efficiently allocate the personnel and physical space it currently 
deploys for the handling of physical copies of PTE submissions.
    Due to the revised rules, 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'' (document 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)'' (document 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 patent electronic filing system also 
includes the document descriptions ``Interim Patent Term Extension 
Request Under 35 U.S.C. 156(e)(2)'' (document 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'' (document code TERM.PTE.DIS) for 
disclosures to the USPTO under 37 CFR 1.765.
    Note that the USPTO changed the document code corresponding to the 
document description ``Disclosure Under 37 CFR 1.765 in a Patent Term 
Extension Application'' to TERM.PTE.DIS from the document code 
TERM.DISCL, which was announced in the notice of proposed rulemaking 
published on May 6, 2022, at 87 FR 27043. The document code TERM.DISCL 
was being erroneously used by filers for the submissions of terminal 
disclaimers. 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.
    The USPTO patent electronic filing system includes the document 
description ``Limited POA and/or Change of Address for a Patent Term 
Extension Application'' (document 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 (POA) 
or limited POA 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 POAs specifying that the power is limited to 
prosecution of the PTE application. A limited POA filed using the 
document description ``Limited POA and/or Change of Address for a 
Patent Term Extension Application'' (document 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'' (document 
code PTE.POA), should be used. A change of address filed using the 
document description, ``Limited POA and/or Change of Address for a 
Patent Term Extension Application'' (document 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 or requests for 
interim extension of the patent term under 35 U.S.C. 156(e)(2) and 37 
CFR 1.760. Use of the correct document description may be verified by 
reviewing the EFS Acknowledgement Receipt (document 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 [email protected].
    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 patent electronic 
filing system includes the document description, ``Continuation of 
Patent Term Extension Application'' (document 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.
    In the limited circumstance when the USPTO patent electronic filing 
system is unavailable during an unscheduled outage and a PTE 
application, interim PTE application, or any related submission to the 
USPTO cannot be filed electronically, the USPTO may, on its own 
initiative, waive the electronic filing requirement under 37 CFR 
1.740(b) for the application or submission to enable the application or 
submission to be filed by hand-delivery to the USPTO, or via the 
``Priority Mail Express[supreg]'' service of the United States Postal 
Service in accordance with 37 CFR 1.10, and be entitled to a filing 
date. When submitting by hand-delivery or ``Priority Mail 
Express[supreg],'' the PTE applicant must provide an explanation of the 
unavailability of the USPTO patent electronic filing system.
    The filing fee under 37 CFR 1.20(j) is not a filing date 
requirement under 37 CFR 1.741(a). PTE applications and interim PTE 
applications will receive a filing date without the filing fee. If the 
USPTO patent electronic filing system is available, but the fee payment 
component of the USPTO patent electronic filing system is not accepting 
payment, PTE applicants may include an authorization to charge a 
deposit account as an acceptable form of payment (see 37 CFR 1.25(b)) 
or they may delay payment to a later time. If

[[Page 13030]]

payment has not been made by the time the USPTO processes the 
application, the USPTO will notify the PTE applicant to pay the 37 CFR 
1.20(j) filing fee, in accordance with 37 CFR 1.740(c).

Discussion of Specific Rules

    The following is a discussion of the amendments to 37 CFR part 1.
    Section 1.740: Section 1.740(a)(15) is 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 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. This final rule 
removes from Sec.  1.740(b) the requirement to file each PTE 
application in triplicate.
    Section 1.741: Section 1.741(a) is 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). In view of the requirement to 
file PTE applications via the USPTO patent electronic filing system, 
this final rule removes from Sec.  1.741(a) the provision that provided 
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.
    Section 1.770 is amended to remove the requirement to file 
duplicates of express declarations of withdrawal of PTE applications. 
The requirement is no longer needed in view of the requirement to file 
submissions related to PTE applications via the USPTO patent electronic 
filing system.
    Section 1.790: Section 1.790(a) is amended to clarify that the 
referenced paragraphs are paragraphs of 35 U.S.C. 156(g). Additionally, 
the time periods previously in Sec.  1.790(a) for filing initial and 
subsequent applications for interim extension are moved to new 
paragraphs (c)(1) and (d)(1), respectively, of this section.
    Section 1.790(b) is 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. This final rule moves the provisions regarding a 
complete application for interim extension from Sec.  1.790(b) to new 
paragraph (c)(2) of this section.
    Section 1.790(c) is amended to provide the requirements for 
complete initial applications for interim extension. Newly added Sec.  
1.790(c)(1) contains the time period for filing an initial interim 
extension application previously in Sec.  1.790(a). It also requires a 
statement that the initial application is being submitted within the 
time period and an identification of the date of the last day on which 
the initial application could be submitted. Newly added Sec.  
1.790(c)(2) contains the provisions regarding a complete interim 
extension application previously in Sec.  1.790(b). Paragraphs (a)(16) 
and (17) were removed from Sec.  1.740 on September 8, 2000. 
Accordingly, the reference to Sec.  1.740(a)(16) and (17) previously in 
Sec.  1.790(b) is not carried over to Sec.  1.790(c)(2). Newly added 
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.
    Newly added Sec.  1.790(d) contains the requirements for subsequent 
interim extension applications. Newly added Sec.  1.790(d)(1) contains 
the time period for filing each subsequent interim extension 
application previously in Sec.  1.790(a). It also requires a statement 
that the subsequent application is being submitted within the time 
period and an identification of the date of the last day on which the 
subsequent application could be submitted. Newly added Sec.  
1.790(d)(2) contains provisions regarding the content of each 
subsequent interim extension application previously in Sec.  1.790(c). 
Newly added Sec.  1.790(d)(3) contains the requirement 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, which 
was previously in Sec.  1.790(c).

Changes From the Proposed Rule

    This final rule removes a provision proposed in the May 6, 2022, 
notice of proposed rulemaking. Specifically, Sec.  1.790(c)(3) does not 
include the proposed requirement to identify 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. The proposed requirement is 
unnecessary in view of the requirements set forth in Sec.  
1.740(a)(10), e.g., the requirement in Sec.  1.740(a)(10)(i)(B) to 
provide the new drug application number for a patent claiming a human 
drug. A complete initial application for interim extension must meet 
the requirements set forth in Sec.  1.740(a)(10) under newly added 
Sec.  1.790(c)(2) (previously under Sec.  1.790(b)).

Comments and Responses to Comments

    The May 6, 2022, notice of proposed rulemaking solicited public 
comments on the proposed amendments to 37 CFR part 1 being adopted in 
this final rule. The USPTO received written input from two commenters 
on the proposed rule. Summaries of the comments and the USPTO's 
responses to the written comments follow.
    Comment 1: One comment noted that, because a limited POA document 
might be submitted as an exhibit to an initially-filed PTE application 
or initially-filed interim PTE application, either the document 
description ``Limited POA and/or Change of Address for a Patent Term 
Extension Application'' (document code PTE.POA) or the document 
description ``Continuation of Patent Term Extension Application'' 
(document code PTE.APPENDIX) might be used. The comment asked the USPTO 
to clarify that either would be acceptable for initial filings and that 
changes in power filed subsequent to the initial filings should use the 
document description ``Limited POA and/or Change of Address for a 
Patent Term Extension Application'' (document code PTE.POA).
    Response: Yes, PTE applicants may continue to include limited POAs 
for PTE applications as part of an appendix

[[Page 13031]]

document that is submitted using the document description 
``Continuation of Patent Term Extension Application'' (document code 
PTE.APPENDIX). However, the USPTO prefers all limited POAs for PTE 
applications to be filed as a separate document using the document 
description ``Limited POA and/or Change of Address for a Patent Term 
Extension Application'' (document code PTE.POA). By doing so, the 
limited POA is more readily identifiable in the electronic file 
wrapper.
    Comment 2: One comment expressed concern that electronic filing 
could significantly exacerbate the unauthorized filing of PTE 
applications by patent owners who are not the marketing applicant or 
its agent. The comment proposes that the USPTO address the issue by 
amending 37 CFR 1.740 to expressly require, in any PTE application 
where the patent owner is a different and unrelated entity from the 
marketing applicant, an authorization letter from the marketing 
applicant allowing the patent owner to rely on the regulatory review 
period activities of the marketing applicant. The comment further 
proposes that such an authorization letter would need to be submitted 
during the pendency of the PTE application.
    Response: The USPTO understands the commenter's concern. However, 
the proposal is outside the scope of the current rulemaking. The USPTO 
will consider requiring an authorization letter in a future rulemaking.
    Comment 3: One comment asked the USPTO to continue to allow the 
filing of trade secret, proprietary, and protective order material on 
paper in PTE applications using the procedures of MPEP sections 724.02 
and 2760.
    Response: The process for filing trade secret, proprietary, and/or 
protective order material on paper in PTE applications using the 
procedures of MPEP sections 724.02 and 2760 is not being changed by 
this final rule. If the USPTO receives a submission in accordance with 
the procedures of MPEP sections 724.02 and 2760, the USPTO will, on its 
own initiative, waive the electronic filing requirement under 37 CFR 
1.740(b) for the submission.
    Comment 4: One comment asked the USPTO to consider a provision that 
would allow a PTE applicant to submit a PTE application on paper if the 
USPTO's patent electronic filing system is not working.
    Response: As stated earlier, in the limited circumstance when the 
USPTO patent electronic filing system is unavailable during an 
unscheduled outage, the USPTO may waive the electronic filing 
requirement under 37 CFR 1.740(b) for a PTE application, interim PTE 
application, or any related submission to the USPTO, if the application 
or submission is accompanied by an explanation of the unavailability of 
the USPTO patent electronic filing system and requests waiver (a 
petition under 37 CFR 1.183 is not required).
    Comment 5: One comment requested that the USPTO ensure that all PTE 
correspondence becomes part of the USPTO's electronic system that 
provides applicants with an email notification that a new document has 
been added to the electronic file wrapper.
    Response: The USPTO understands the comment to be requesting that 
all USPTO communications issued with respect to a PTE application be 
included in the USPTO's e-Office Action program. See www.uspto.gov/patents/apply/checking-application-status/e-office-action-program. The 
electronic notification system currently used by the USPTO for its e-
Office Action program cannot accommodate communications issued with 
respect to a PTE application. If that changes, the USPTO will revisit 
the matter. In the interim, the USPTO will endeavor to notify the PTE 
applicant of any outgoing USPTO PTE correspondence via the email 
address provided under 37 CFR 1.740(a)(15).

Rulemaking Requirements

    A. Administrative Procedure Act: The changes in this rulemaking 
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 are 
procedural where they do not change the substantive standard for 
reviewing claims); 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).
    Prior notice and opportunity for public comment for the changes in 
this rulemaking were not required pursuant to 5 U.S.C. 553(b) or (c), 
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), 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 chose to seek public comment before 
implementing the rule to benefit from the public's input.
    B. Regulatory Flexibility Act: For the reasons set forth in this 
final rule, 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 changes in 
this rule will not have a significant economic impact on a substantial 
number of small entities (see 5 U.S.C. 605(b)).
    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 in this rule are procedural in nature and are not 
expected to result in significant costs to applicants. The rules of 
practice prior to this final rule already permitted 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 were being filed electronically prior to this final rule. 
Accordingly, the 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 PTE 
applicants. As for the rule change requiring PTE applications to be 
filed electronically, although this is a change in practice, 
stakeholders have unanimously communicated support for the USPTO's 
waiver of the prohibition against electronic filing of PTE applications 
as a result of the COVID-19 outbreak, and the rule change is not 
expected to result in any additional cost to applicants.
    Thus, this rule change requiring PTE applications to be filed 
electronically is not expected to negatively impact stakeholders' PTE 
practice.
    The USPTO patent electronic filing system allows PTE applicants to 
file PTE documents through a standard web browser without downloading 
special software, changing documentation preparation tools, or altering 
workflow processes. PTE applicants may create documents using the tools 
and processes that they already use, and then convert those documents 
into standard PDF files for submission

[[Page 13032]]

through the USPTO's patent electronic filing system.
    For these reasons, the changes 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 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 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 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 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 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 USPTO will submit a report containing 
the final 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 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 rulemaking is not expected to result in 
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 (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 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 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 rulemaking does not contain provisions that involve the use of 
technical standards.
    O. Paperwork Reduction Act of 1995: The Paperwork Reduction Act of 
1995 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 
rulemaking have already been approved under the Office of Management 
and Budget (OMB) Control Number 0651-0020 (Patent Term Extension and 
Adjustment). However, 0651-0020 is being updated to reflect a net 
reduction in burden (time). Taking into consideration the removal of 
the requirement to file PTE applications in paper in triplicate and the 
additional requirements of newly added 37 CFR 1.790(c)(1) and (d)(1), 
the USPTO estimates that this information collection's annual burden 
will decrease by a total of approximately 72 burden hours. This 
estimate is based on the response volumes associated with the most 
recent OMB submissions for this information collection.
    Notwithstanding any other provision of law, no person is required 
to respond to, nor shall a person be subject to a penalty for failure 
to comply with, a collection of information subject to the requirements 
of the Paperwork Reduction Act unless that collection of information 
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 amends 37 CFR 
part 1 as follows:

[[Page 13033]]

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 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).
    (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.
    (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. 2023-04162 Filed 3-1-23; 8:45 am]
BILLING CODE 3510-16-P