Adoption of Updated WIPO Standard ST.26; Revision to Incorporation by Reference, 34089-34091 [2023-11365]
Download as PDF
Federal Register / Vol. 88, No. 102 / Friday, May 26, 2023 / Rules and Regulations
For the reasons discussed in the
preamble, the Coast Guard amends 33
CFR part 165 as follows:
DEPARTMENT OF COMMERCE
PART 165—REGULATED NAVIGATION
AREAS AND LIMITED ACCESS AREAS
37 CFR Part 1
1. The authority citation for part 165
continues to read as follows:
RIN 0651–AD69
Patent and Trademark Office
■
Authority: 46 U.S.C. 70034, 70051, 70124;
33 CFR 1.05–1, 6.04–1, 6.04–6, and 160.5;
Department of Homeland Security Delegation
No. 00170.1, Revision No. 01.3.
2. Add § 165.T08–0390 to read as
follows:
■
ddrumheller on DSK120RN23PROD with RULES1
(a) Location. The following area is a
safety zone: all navigable waters of the
La Quinta Channel between gated pair
lights 11 and 12 to the Sea buoy. Entry
of vessels or persons into this zone is
prohibited unless specifically
authorized by the Captain of the Port
Sector Corpus Christi (COTP) or a
designated representative.
(b) Enforcement period. This section
will be enforced from 11 p.m. on May
27, 2023 through 11 a.m. on May 28,
2023.
(c) Regulations. (1) According to the
general regulations in § 165.23 of this
part, entry into this temporary safety
zone is prohibited unless authorized by
the COTP or a designated
representative. They may be contacted
on Channel 16 VHF–FM (156.8 MHz) or
by telephone at 361–939–0450.
(2) If permission is granted, all
persons and vessels shall comply with
the instructions of the COTP or
designated representative.
(d) Information broadcasts. The COTP
or a designated representative will
inform the public of the enforcement
times and date for this safety zone
through Broadcast Notices to Mariners,
Local Notices to Mariners, and/or Safety
Marine Information Broadcasts as
appropriate.
[FR Doc. 2023–11387 Filed 5–24–23; 4:15 pm]
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Adoption of Updated WIPO Standard
ST.26; Revision to Incorporation by
Reference
United States Patent and
Trademark Office, Department of
Commerce.
ACTION: Final rule.
AGENCY:
The United States Patent and
Trademark Office (USPTO or Office) is
adopting the recently revised World
Intellectual Property Organization
(WIPO) Standard ST.26, version 1.6,
approved November 25, 2022, for
incorporation by reference into its
regulations addressing application
disclosures containing nucleotide and/
or amino acid sequences. The USPTO is
also correcting a grammatical oversight
in one of its sequence regulations. The
USPTO first amended its rules in 2022
to incorporate by reference certain
provisions of WIPO Standard ST.26. In
addition to simplifying the process for
applicants filing in multiple countries,
the ST.26 requirement to submit a single
sequence listing in eXtensible Mark-up
Language (XML) format provides better
preservation, accessibility, and sorting
of the submitted sequence data for the
public. Among other improvements, the
new version of ST.26 clarifies
requirements, improves descriptions,
and corrects editorial mistakes.
DATES: This final rule is effective on July
1, 2023. The incorporation by reference
of certain publications listed in this rule
is approved by the Director of the
Federal Register as of July 1, 2023.
FOR FURTHER INFORMATION CONTACT:
Mary C. Till, Senior Legal Advisor,
Office of Patent Legal Administration,
Office of the Deputy Commissioner for
Patents, at Mary.Till@uspto.gov or 571–
272–7755; or Ali Salimi, Senior Legal
Advisor, Office of Patent Legal
Administration, Office of the Deputy
Commissioner for Patents, at
Ali.Salimi@uspto.gov or 571–272–0909.
SUPPLEMENTARY INFORMATION: The
‘‘WIPO Handbook on Intellectual
Property Information and
Documentation’’ (formerly the ‘‘WIPO
Handbook on Industrial Property
Information and Documentation’’) sets
forth standards for the presentation of
data in many contexts. One such
standard is WIPO Standard ST.26,
which is titled ‘‘RECOMMENDED
SUMMARY:
§ 165.T08–0390 Safety Zone; La Quinta
and Corpus Christi Shipping Channel,
Ingleside, TX.
Dated: May 22, 2023.
J.B. Gunning,
Captain, U.S. Coast Guard, Captain of the
Port Sector Corpus Christi.
[Docket No. PTO–P–2023–0013]
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34089
STANDARD FOR THE PRESENTATION
OF NUCLEOTIDE AND AMINO ACID
SEQUENCE LISTINGS USING XML
(EXTENSIBLE MARKUP LANGUAGE).’’
WIPO Standard ST.26 defines the
disclosures of nucleotide and/or amino
acid sequences in patent applications
that must be presented in a sequence
listing in XML format in the manner
specified in the standard.
In a rulemaking published May 20,
2022, at 87 FR 30806, the USPTO
created new rules 37 CFR 1.831–1.839
that incorporate by reference WIPO
Standard ST.26. 37 CFR 1.839(b)(1)
specifically identifies the version of
WIPO Standard ST.26 that has been
incorporated by reference as ‘‘version
1.5, approved November 5, 2021.’’ On
November 25, 2022, WIPO adopted a
new version (version 1.6) of WIPO
Standard ST.26. As a result, the USPTO
is updating 37 CFR 1.839(b)(1) to reflect
the new version.
WIPO provides free online public
access to view copies of its standards.
WIPO standards that are incorporated
into Federal regulations are available to
the public for free viewing on WIPO’s
website at https://www.wipo.int/export/
sites/www/standards/en/pdf/03-26-01_
v1_6.pdf. In addition to the free online
availability of this standard on WIPO’s
website, WIPO Standard ST.26 is
available on the USPTO’s Sequence
Listing Resource Center at https://
www.uspto.gov/patents/apply/
sequence-listing-resource-center.
WIPO Standard ST.26 is composed of
eight documents, namely, the main
body of the standard, a first annex
(Annex I) setting forth the controlled
vocabulary for use with the main body,
a second annex (Annex II) setting forth
the Document Type Definition (DTD) for
the Sequence Listing, a third annex
(Annex III) containing a sequence listing
specimen (XML file), a fourth annex
(Annex IV) setting forth the character
subset from the Unicode Basic Latin
Code Table, a fifth annex (Annex V)
setting forth additional data exchange
requirements for IPOs, a sixth annex
(Annex VI) containing a guidance
document with illustrated examples,
and a seventh annex (Annex VII) setting
forth recommendations for the
transformation of a sequence listing
from WIPO Standard ST.25 format to
WIPO Standard ST.26 format, including
guidance on how to avoid adding or
deleting subject matter.
Revisions to WIPO Standard ST.26
under the newly adopted version affect
the main body, Annex I, Annex II,
Annex VI, and Annex VII. The changes
to the main body serve to clarify
requirements, improve descriptions (for
example, by better defining the value
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34090
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ddrumheller on DSK120RN23PROD with RULES1
needed for an application number), and
correct editorial mistakes. Similarly, the
changes to Annex I, Annex II and Annex
VII clarify the format of values for
identifiers that are part of the ‘‘Sequence
Listing XML,’’ revise grammar, and
clarify values that are languagedependent. Annex VI includes three
new examples of the manner in which
(1) a circular nucleotide sequence is
exemplified, (2) a post-translationally
modified amino acid is exemplified, and
(3) representation of a single sequence
with enumerated alternative amino
acids that may be modified amino acids
is exemplified. Throughout the main
body of WIPO Standard ST.26, reference
to ‘‘international, national or regional
procedures’’ have been updated to
reflect that order for consistency.
Furthermore, all instances of ‘‘industrial
property’’ in the main body of WIPO
Standard ST.26 have been updated to
‘‘intellectual property.’’ Thus, the
changes in newly adopted version 1.6 of
WIPO Standard ST.26 are ministerial
changes that will not have a meaningful
substantive impact on disclosing
parties.
Additionally, the USPTO revises 37
CFR 1.831(a) to correct a grammatical
oversight. 37 CFR 1.831(d) corresponds
to WIPO Standard ST.26, paragraph
3(c)(i) and (ii), and recites ‘‘enumeration
of its residues,’’ but 37 CFR 1.831(a), as
implemented in the May 2022
rulemaking, recited ‘‘enumeration of
their residues.’’ This grammatical error
was an oversight, and the changes in
§ 1.831(a) to replace ‘‘enumeration of
their residues’’ with ‘‘enumeration of its
residues’’ do not impact compliance
with how an amino acid and/or
nucleotide sequence(s), which is
enumerated by its residues, must be
shown in the ‘‘Sequence Listing XML.’’
Discussion of Specific Rules
Section 1.831: Section 1.831(a) is
amended to replace ‘‘Patent applications
disclosing nucleotide and/or amino acid
sequences by enumeration of their
residues . . .’’ with ‘‘Patent applications
disclosing a nucleotide and/or amino
acid sequence(s) by enumeration of its
residues . . .’’ for consistency with
§ 1.831(d) and WIPO Standard ST.26,
paragraph 3(c)(i) and (ii), to which
§ 1.831(d) corresponds. A subsequent
iteration of ‘‘nucleotide and/or amino
acid sequences’’ in § 1.831(a) is revised
to ‘‘nucleotide and/or amino acid
sequence(s)’’ for consistency.
Section 1.839: Section 1.839(b)(1) is
amended to provide an updated citation
to the WIPO Standard ST.26 that is
being incorporated by reference.
Additionally, § 1.839(b)(1) is revised to
reflect an update to the name of the
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16:06 May 25, 2023
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WIPO handbook. Specifically, the
‘‘WIPO Handbook on Industrial
Property Information and
Documentation’’ is now the ‘‘WIPO
Handbook on Intellectual Property
Information and Documentation.’’
Rulemaking Considerations
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) (changes to
procedural rules are not subject to
notice and comment review under the
Administrative Procedure Act (APA));
Inova Alexandria Hosp. v. Shalala, 244
F.3d 342, 349 (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) (Substantive rules
‘‘effect a change in existing law or
policy or which affect individual rights
and obligations,’’ whereas interpretative
rules ‘‘clarify or explain existing law or
regulation and are exempt from notice
and comment’’ review under the APA.).
Accordingly, prior notice and
opportunity for public comment for the
changes in this rulemaking are 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))).
In addition, the Office finds good
cause pursuant to the authority at 5
U.S.C. 553(b)(B) to dispense with prior
notice and opportunity for public
comment because such procedures are
unnecessary in this instance. The
changes in this rulemaking merely
update the regulations to incorporate by
reference version 1.6 of WIPO Standard
ST.26, which was adopted on November
25, 2022, by the WIPO Committee on
Standards, and to make a correction to
the regulations at 37 CFR 1.831(a) to
correct a grammatical oversight in a
definition. These revisions are largely
procedural in nature, and do not impose
any additional requirements or fees on
applicants. Thus, the USPTO
implements this final rule without prior
notice and opportunity for comment.
B. Regulatory Flexibility Act: As prior
notice and an opportunity for public
comment are not required pursuant to 5
U.S.C. 553 or any other law, neither a
Regulatory Flexibility Act analysis nor a
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certification under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.) is
required. See 5 U.S.C. 603.
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, to the extent feasible and
applicable, the USPTO has: (1)
reasonably determined that the benefits
of the rule justify its costs; (2) tailored
the rule to impose the least burden on
society consistent with obtaining the
agency’s 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 while
maintaining 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
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Federal Register / Vol. 88, No. 102 / Friday, May 26, 2023 / Rules and Regulations
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
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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:
This final rule does not impact
information collection requirements that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.).
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, Incorporation by
reference, Inventions and patents,
Reporting and recordkeeping
requirements, Small businesses.
For the reasons stated in the preamble
and under the authority contained in 35
U.S.C. 2, as amended, the USPTO
amends 37 CFR part 1 as follows:
34091
‘‘Sequence Listing XML’’ contains the
information of the nucleotide and/or
amino acid sequence(s) disclosed in the
patent application using the symbols
and format in accordance with the
requirements of §§ 1.832 through 1.834.
*
*
*
*
*
3. In § 1.839, revise paragraph (b)(1) to
read as follows:
■
§ 1.839
Incorporation by reference.
*
*
*
*
*
(b) * * *
(1) WIPO Standard ST.26. WIPO
Handbook on Intellectual Property
Information and Documentation,
Standard ST.26: Recommended
Standard for the Presentation of
Nucleotide and Amino Acid Sequence
Listings Using XML (eXtensible Markup
Language) including Annexes I–VII,
version 1.6, approved November 25,
2022; IBR approved for §§ 1.831 through
1.834.
*
*
*
*
*
Katherine K. Vidal,
Under Secretary of Commerce for Intellectual
Property and Director of the United States
Patent and Trademark Office.
[FR Doc. 2023–11365 Filed 5–25–23; 8:45 am]
BILLING CODE 3510–16–P
ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 52
[EPA–R10–OAR–2022–0753, FRL–10190–
02–R10]
PART 1—RULES OF PRACTICE IN
PATENT CASES
Air Plan Approval; ID; State Board
Composition
■
1. The authority citation for part 1
continues to read as follows:
AGENCY:
Authority: 35 U.S.C. 2(b)(2), unless
otherwise noted.
SUMMARY:
2. In § 1.831, revise paragraph (a) to
read as follows:
■
§ 1.831 Requirements for patent
applications filed on or after July 1, 2022,
having nucleotide and/or amino acid
sequence disclosures.
(a) Patent applications disclosing a
nucleotide and/or amino acid
sequence(s) by enumeration of its
residues, as defined in paragraph (b) of
this section, must contain, as a separate
part of the disclosure, a computer
readable Sequence Listing in XML
format (a ‘‘Sequence Listing XML’’).
Disclosed nucleotide or amino acid
sequences that do not meet the
definition in paragraph (b) of this
section must not be included in the
‘‘Sequence Listing XML.’’ The
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Environmental Protection
Agency (EPA).
ACTION: Final rule.
The Environmental Protection
Agency (EPA) is approving a revision to
the Idaho State Implementation Plan
(SIP) submitted on August 9, 2022. The
revision was submitted to meet the state
board composition requirements of the
Clean Air Act.
DATES: This final rule is effective June
26, 2023.
ADDRESSES: The EPA has established a
docket for this action under Docket ID
No. EPA–R10–OAR–2022–0753. All
documents in the docket are listed on
the https://www.regulations.gov
website. Although listed in the index,
some information is not publicly
available, e.g., Confidential Business
Information or other information the
disclosure of which is restricted by
statute. Certain other material, such as
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[Federal Register Volume 88, Number 102 (Friday, May 26, 2023)]
[Rules and Regulations]
[Pages 34089-34091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-11365]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
Patent and Trademark Office
37 CFR Part 1
[Docket No. PTO-P-2023-0013]
RIN 0651-AD69
Adoption of Updated WIPO Standard ST.26; Revision to
Incorporation by Reference
AGENCY: United States Patent and Trademark Office, Department of
Commerce.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The United States Patent and Trademark Office (USPTO or
Office) is adopting the recently revised World Intellectual Property
Organization (WIPO) Standard ST.26, version 1.6, approved November 25,
2022, for incorporation by reference into its regulations addressing
application disclosures containing nucleotide and/or amino acid
sequences. The USPTO is also correcting a grammatical oversight in one
of its sequence regulations. The USPTO first amended its rules in 2022
to incorporate by reference certain provisions of WIPO Standard ST.26.
In addition to simplifying the process for applicants filing in
multiple countries, the ST.26 requirement to submit a single sequence
listing in eXtensible Mark-up Language (XML) format provides better
preservation, accessibility, and sorting of the submitted sequence data
for the public. Among other improvements, the new version of ST.26
clarifies requirements, improves descriptions, and corrects editorial
mistakes.
DATES: This final rule is effective on July 1, 2023. The incorporation
by reference of certain publications listed in this rule is approved by
the Director of the Federal Register as of July 1, 2023.
FOR FURTHER INFORMATION CONTACT: Mary C. Till, Senior Legal Advisor,
Office of Patent Legal Administration, Office of the Deputy
Commissioner for Patents, at [email protected] or 571-272-7755; or
Ali Salimi, Senior Legal Advisor, Office of Patent Legal
Administration, Office of the Deputy Commissioner for Patents, at
[email protected] or 571-272-0909.
SUPPLEMENTARY INFORMATION: The ``WIPO Handbook on Intellectual Property
Information and Documentation'' (formerly the ``WIPO Handbook on
Industrial Property Information and Documentation'') sets forth
standards for the presentation of data in many contexts. One such
standard is WIPO Standard ST.26, which is titled ``RECOMMENDED STANDARD
FOR THE PRESENTATION OF NUCLEOTIDE AND AMINO ACID SEQUENCE LISTINGS
USING XML (EXTENSIBLE MARKUP LANGUAGE).'' WIPO Standard ST.26 defines
the disclosures of nucleotide and/or amino acid sequences in patent
applications that must be presented in a sequence listing in XML format
in the manner specified in the standard.
In a rulemaking published May 20, 2022, at 87 FR 30806, the USPTO
created new rules 37 CFR 1.831-1.839 that incorporate by reference WIPO
Standard ST.26. 37 CFR 1.839(b)(1) specifically identifies the version
of WIPO Standard ST.26 that has been incorporated by reference as
``version 1.5, approved November 5, 2021.'' On November 25, 2022, WIPO
adopted a new version (version 1.6) of WIPO Standard ST.26. As a
result, the USPTO is updating 37 CFR 1.839(b)(1) to reflect the new
version.
WIPO provides free online public access to view copies of its
standards. WIPO standards that are incorporated into Federal
regulations are available to the public for free viewing on WIPO's
website at https://www.wipo.int/export/sites/www/standards/en/pdf/03-26-01_v1_6.pdf. In addition to the free online availability of this
standard on WIPO's website, WIPO Standard ST.26 is available on the
USPTO's Sequence Listing Resource Center at https://www.uspto.gov/patents/apply/sequence-listing-resource-center.
WIPO Standard ST.26 is composed of eight documents, namely, the
main body of the standard, a first annex (Annex I) setting forth the
controlled vocabulary for use with the main body, a second annex (Annex
II) setting forth the Document Type Definition (DTD) for the Sequence
Listing, a third annex (Annex III) containing a sequence listing
specimen (XML file), a fourth annex (Annex IV) setting forth the
character subset from the Unicode Basic Latin Code Table, a fifth annex
(Annex V) setting forth additional data exchange requirements for IPOs,
a sixth annex (Annex VI) containing a guidance document with
illustrated examples, and a seventh annex (Annex VII) setting forth
recommendations for the transformation of a sequence listing from WIPO
Standard ST.25 format to WIPO Standard ST.26 format, including guidance
on how to avoid adding or deleting subject matter.
Revisions to WIPO Standard ST.26 under the newly adopted version
affect the main body, Annex I, Annex II, Annex VI, and Annex VII. The
changes to the main body serve to clarify requirements, improve
descriptions (for example, by better defining the value
[[Page 34090]]
needed for an application number), and correct editorial mistakes.
Similarly, the changes to Annex I, Annex II and Annex VII clarify the
format of values for identifiers that are part of the ``Sequence
Listing XML,'' revise grammar, and clarify values that are language-
dependent. Annex VI includes three new examples of the manner in which
(1) a circular nucleotide sequence is exemplified, (2) a post-
translationally modified amino acid is exemplified, and (3)
representation of a single sequence with enumerated alternative amino
acids that may be modified amino acids is exemplified. Throughout the
main body of WIPO Standard ST.26, reference to ``international,
national or regional procedures'' have been updated to reflect that
order for consistency. Furthermore, all instances of ``industrial
property'' in the main body of WIPO Standard ST.26 have been updated to
``intellectual property.'' Thus, the changes in newly adopted version
1.6 of WIPO Standard ST.26 are ministerial changes that will not have a
meaningful substantive impact on disclosing parties.
Additionally, the USPTO revises 37 CFR 1.831(a) to correct a
grammatical oversight. 37 CFR 1.831(d) corresponds to WIPO Standard
ST.26, paragraph 3(c)(i) and (ii), and recites ``enumeration of its
residues,'' but 37 CFR 1.831(a), as implemented in the May 2022
rulemaking, recited ``enumeration of their residues.'' This grammatical
error was an oversight, and the changes in Sec. 1.831(a) to replace
``enumeration of their residues'' with ``enumeration of its residues''
do not impact compliance with how an amino acid and/or nucleotide
sequence(s), which is enumerated by its residues, must be shown in the
``Sequence Listing XML.''
Discussion of Specific Rules
Section 1.831: Section 1.831(a) is amended to replace ``Patent
applications disclosing nucleotide and/or amino acid sequences by
enumeration of their residues . . .'' with ``Patent applications
disclosing a nucleotide and/or amino acid sequence(s) by enumeration of
its residues . . .'' for consistency with Sec. 1.831(d) and WIPO
Standard ST.26, paragraph 3(c)(i) and (ii), to which Sec. 1.831(d)
corresponds. A subsequent iteration of ``nucleotide and/or amino acid
sequences'' in Sec. 1.831(a) is revised to ``nucleotide and/or amino
acid sequence(s)'' for consistency.
Section 1.839: Section 1.839(b)(1) is amended to provide an updated
citation to the WIPO Standard ST.26 that is being incorporated by
reference. Additionally, Sec. 1.839(b)(1) is revised to reflect an
update to the name of the WIPO handbook. Specifically, the ``WIPO
Handbook on Industrial Property Information and Documentation'' is now
the ``WIPO Handbook on Intellectual Property Information and
Documentation.''
Rulemaking Considerations
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) (changes to procedural rules are not subject to notice and
comment review under the Administrative Procedure Act (APA)); Inova
Alexandria Hosp. v. Shalala, 244 F.3d 342, 349 (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) (Substantive rules ``effect a change in existing law or policy or
which affect individual rights and obligations,'' whereas
interpretative rules ``clarify or explain existing law or regulation
and are exempt from notice and comment'' review under the APA.).
Accordingly, prior notice and opportunity for public comment for
the changes in this rulemaking are 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))).
In addition, the Office finds good cause pursuant to the authority
at 5 U.S.C. 553(b)(B) to dispense with prior notice and opportunity for
public comment because such procedures are unnecessary in this
instance. The changes in this rulemaking merely update the regulations
to incorporate by reference version 1.6 of WIPO Standard ST.26, which
was adopted on November 25, 2022, by the WIPO Committee on Standards,
and to make a correction to the regulations at 37 CFR 1.831(a) to
correct a grammatical oversight in a definition. These revisions are
largely procedural in nature, and do not impose any additional
requirements or fees on applicants. Thus, the USPTO implements this
final rule without prior notice and opportunity for comment.
B. Regulatory Flexibility Act: As prior notice and an opportunity
for public comment are not required pursuant to 5 U.S.C. 553 or any
other law, neither a Regulatory Flexibility Act analysis nor a
certification under the Regulatory Flexibility Act (5 U.S.C. 601 et
seq.) is required. See 5 U.S.C. 603.
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, to the extent feasible and applicable, the USPTO
has: (1) reasonably determined that the benefits of the rule justify
its costs; (2) tailored the rule to impose the least burden on society
consistent with obtaining the agency's 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 while
maintaining 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
[[Page 34091]]
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: This final rule does not impact
information collection requirements that are subject to review by the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.).
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, Incorporation by reference, Inventions and patents,
Reporting and recordkeeping requirements, Small businesses.
For the reasons stated in the preamble and under the authority
contained in 35 U.S.C. 2, as amended, the USPTO amends 37 CFR part 1 as
follows:
PART 1--RULES OF PRACTICE IN PATENT CASES
0
1. The authority citation for part 1 continues to read as follows:
Authority: 35 U.S.C. 2(b)(2), unless otherwise noted.
0
2. In Sec. 1.831, revise paragraph (a) to read as follows:
Sec. 1.831 Requirements for patent applications filed on or after
July 1, 2022, having nucleotide and/or amino acid sequence disclosures.
(a) Patent applications disclosing a nucleotide and/or amino acid
sequence(s) by enumeration of its residues, as defined in paragraph (b)
of this section, must contain, as a separate part of the disclosure, a
computer readable Sequence Listing in XML format (a ``Sequence Listing
XML''). Disclosed nucleotide or amino acid sequences that do not meet
the definition in paragraph (b) of this section must not be included in
the ``Sequence Listing XML.'' The ``Sequence Listing XML'' contains the
information of the nucleotide and/or amino acid sequence(s) disclosed
in the patent application using the symbols and format in accordance
with the requirements of Sec. Sec. 1.832 through 1.834.
* * * * *
0
3. In Sec. 1.839, revise paragraph (b)(1) to read as follows:
Sec. 1.839 Incorporation by reference.
* * * * *
(b) * * *
(1) WIPO Standard ST.26. WIPO Handbook on Intellectual Property
Information and Documentation, Standard ST.26: Recommended Standard for
the Presentation of Nucleotide and Amino Acid Sequence Listings Using
XML (eXtensible Markup Language) including Annexes I-VII, version 1.6,
approved November 25, 2022; IBR approved for Sec. Sec. 1.831 through
1.834.
* * * * *
Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of
the United States Patent and Trademark Office.
[FR Doc. 2023-11365 Filed 5-25-23; 8:45 am]
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