Rule2023-04162
Establishing Permanent Electronic Filing for Patent Term Extension Applications
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
March 2, 2023
Effective
May 1, 2023
Issuing agencies
Commerce DepartmentPatent and Trademark Office
Abstract
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.
Full Text
<html>
<head>
<title>Federal Register, Volume 88 Issue 41 (Thursday, March 2, 2023)</title>
</head>
<body><pre>[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="/cdn-cgi/l/email-protection#dcacbda8b9b2a8acaebdbfa8b5bfb99ca9afaca8b3f2bbb3aa"><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, 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 <a href="http://www.uspto.gov/patents/apply/filing-online/legal-framework-efs-web">www.uspto.gov/patents/apply/filing-online/legal-framework-efs-web</a> 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 <a href="/cdn-cgi/l/email-protection#2461666764515754504b0a434b52"><span class="__cf_email__" data-cfemail="d095929390a5a3a0a4bffeb7bfa6">[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 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 <a href="http://www.uspto.gov/patents/apply/checking-application-status/e-office-action-program">www.uspto.gov/patents/apply/checking-application-status/e-office-action-program</a>. 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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on March 2, 2023.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.