[Federal Register Volume 87, Number 98 (Friday, May 20, 2022)]
[Rules and Regulations]
[Pages 30806-30821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-10343]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

37 CFR Part 1

[Docket No. PTO-P-2021-0006]
RIN 0651-AD53


Standard for Presentation of Nucleotide and Amino Acid Sequence 
Listings Using eXtensible Markup Language (XML) in Patent Applications 
To Implement WIPO Standard ST.26; Incorporation by Reference

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

ACTION: Final rule.

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SUMMARY: The United States Patent and Trademark Office (USPTO or 
Office) is amending the rules of practice for submitting biological 
sequence data associated with disclosures of nucleotide and amino acid 
sequences in patent applications by incorporating by reference certain 
provisions of World Intellectual Property Office Standard ST.26 (WIPO 
Standard ST.26) into the USPTO rules of practice. Other conforming 
changes to accommodate the new rules of practice based on the new 
standard are also included. In addition to simplifying the process for 
applicants filing in multiple countries, the requirement to submit a 
single sequence listing in eXtensible Markup Language (XML) format, or 
``Sequence Listing XML,'' will result in better preservation, 
accessibility, and sorting of the submitted sequence data for the 
public.

DATES: Effective date: This final rule is effective on July 1, 2022. 
The incorporation by reference of certain publications listed in this 
rule is approved by the Director of the Federal Register as of July 1, 
2022.
    Applicability date: Patent applications filed on or after July 1, 
2022, having disclosures of nucleotide and/or amino acid sequences as 
defined in 37 CFR 1.831(b) must comply with new rules for submission of 
a ``Sequence Listing XML'' in accordance with 37 CFR 1.831 through 
1.835. All other provisions of this final rule apply to all patent 
applications filed before, on, or after July 1, 2022.

FOR FURTHER INFORMATION CONTACT: Mary C. Till, Senior Legal Advisor, 
Office of Patent Legal Administration, Office of the Deputy 
Commissioner for Patents, at <a href="/cdn-cgi/l/email-protection#2865495a51067c414444685d5b585c47064f475e"><span class="__cf_email__" data-cfemail="bcf1ddcec592e8d5d0d0fcc9cfccc8d392dbd3ca">[email protected]</span></a> or 571-272-7755; or 
Ali Salimi, Senior Legal Advisor, Office of Patent Legal 
Administration, Office of the Deputy

[[Page 30807]]

Commissioner for Patents, at <a href="/cdn-cgi/l/email-protection#5f1e3336710c3e333632361f2a2c2f2b3071383029"><span class="__cf_email__" data-cfemail="56173a3f7805373a3f3b3f16232526223978313920">[email protected]</span></a> or 571-272-0909.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
    a. Summary of Changes
    b. Introduction
    c. Incorporation by Reference of WIPO Standard ST.26
    d. Benefits
    e. WIPO Authoring and Validation Tool (WIPO Sequence)
    f. Applicability
II. Discussion of Specific Rules
III. Comments and Responses
IV. Rulemaking Considerations

I. Background

a. Summary of Changes

    WIPO Standard ST.26 is the new international standard developed and 
adopted by WIPO and member states for purposes of presenting 
biotechnology information in patent applications. It will apply to 
international and national applications filed on or after July 1, 2022. 
New provisions in 37 CFR 1.831 through 1.835 implement WIPO Standard 
ST.26. Applications pending prior to July 1, 2022, will not have to 
comply with WIPO Standard ST.26; rather, such applications will require 
the submission of a ``Sequence Listing,'' as defined in 37 CFR 
1.821(a), in compliance with 37 CFR 1.8211.825.
    Under WIPO Standard ST.26 (as implemented by 37 CFR 1.831 through 
1.835), patent applications that contain disclosures of nucleotide and/
or amino acid sequences must present the associated biological sequence 
data in a standardized electronic format (a ``Sequence Listing XML'') 
as a separate part of the specification. In particular, WIPO Standard 
ST.26 permits applicants to submit a single, internationally acceptable 
sequence listing in a language-neutral format using specified 
International Nucleotide Sequence Database Collaboration (INSDC) 
identifiers in international applications filed under the Patent 
Cooperation Treaty (PCT) and in national and regional applications in 
the intellectual property offices (IPOs) of WIPO member states. As a 
result, a single sequence listing in compliance with WIPO Standard 
ST.26 can be prepared for use in the IPOs of WIPO member states.
    For applications filed on or after July 1, 2022, the changes in 
this final rule include the: (1) Creation of new rules (37 CFR 1.831 
through 1.839) that incorporate by reference WIPO Standard ST.26; (2) 
use of INSDC sequence data elements to replace numeric identifiers used 
in the previous Standard ST.25 for the submission of nucleotide and/or 
amino acid sequences; (3) modification of rules of practice to include 
reference to a ``Sequence Listing XML''; (4) elimination of the ability 
to file a paper or Portable Document Format (PDF) copy of nucleotide 
and/or amino acid sequences; (5) elimination of the option to include 
within a ``Sequence Listing XML,'' sequences with fewer than 4 
specifically defined amino acids and fewer than 10 specifically defined 
nucleotides; and (6) clarification and simplification of the rules to 
aid in understanding the requirements set forth.

b. Introduction

    In an effort to streamline and reduce existing procedural 
requirements and to implement WIPO Standard ST.26, the USPTO is 
amending its rules of practice (by adding 37 CFR 1.831 through 1.839) 
for submitting biological sequence data associated with disclosures of 
nucleotide and/or amino acid sequences in patent applications filed on 
or after July 1, 2022. These changes also respond to the needs of our 
customers to comply with WIPO Standard ST.26.
    To decrease the burden on applicants who file patent applications 
containing nucleotide and/or amino acid sequences internationally, the 
USPTO has worked with other WIPO member states as part of the Committee 
on WIPO Standards (CWS) to develop a single, internationally acceptable 
sequence listing standard for use in patent applications filed in those 
member states. Beginning in October of 2010, the CWS established a task 
force to propose a revised standard for the filing of nucleotide and/or 
amino acid sequence listings in XML file format. To obtain public input 
on the content of WIPO Standard ST.26, the USPTO issued requests for 
comments in 2012 and 2016. See Request for Comments on the 
Recommendation for the Disclosure of Sequence Listings Using XML 
(Proposed ST.26), 77 FR 28541 (May 15, 2012); and Standard ST.26--
Request for Comments on the Recommended Standard for the Presentation 
of Nucleotide and Amino Acid Sequence Listings Using XML (eXtensible 
Markup Language), 81 FR 74775 (October 27, 2016). The adopted version 
of WIPO Standard ST.26 takes those comments into account. To achieve 
the goals WIPO and its member states (including the United States) set 
out by developing the sequence listing standard for presenting data 
consistently across all IPOs, all WIPO member states agreed to 
implement WIPO Standard ST.26 for international and national 
applications filed on or after July 1, 2022. Therefore, in view of this 
final rule, applications filed in the United States on or after July 1, 
2022, will need to conform to WIPO Standard ST.26 as implemented in 37 
CFR 1.831 through 1.839, which requires submitting sequence listings in 
XML format.
    Under the final rule, applications that claim benefit or priority 
to an earlier application, where the earlier application contained a 
sequence listing that complied with the requirements of Standard ST.25 
or other earlier requirements, must comply with the new rules that 
incorporate by reference WIPO Standard ST.26. To facilitate compliance, 
WIPO, with input from WIPO member states, developed WIPO Sequence, a 
sequence listing authoring and validating tool that applicants can use 
to prepare and validate their sequence listings in XML format, as 
discussed below. The USPTO is adding to the patent rules (37 CFR part 
1) by incorporating by reference WIPO Standard ST.26, and providing 
conforming amendments to the current rules.
    To ensure that biological sequence data associated with the 
disclosures of nucleotide and/or amino acid sequences in patent 
applications can be widely disseminated and searchable by the public 
and IPOs, the USPTO works with the National Center for Biotechnology 
Information (NCBI) on the inclusion of patent sequence data in the 
GenBank searchable database. For the NCBI to include all sequence data 
from the USPTO, the data must be provided in INSDC format so it is 
compatible with GenBank. The Standard ST.25 format sequence listings 
cannot be readily converted to INSDC format, resulting in only a 
fraction of patent sequence information appearing in GenBank. This data 
loss limits the sequence information available to the public and 
exchanged with other sequence database providers (e.g., the National 
Institute of Genetics (NIG) in Japan, the DNA Data Bank of Japan 
(DDBJ), and the European Molecular Biology Laboratory, European 
Bioinformatics Institute (EMBL-EBI). WIPO has been working with the 
WIPO member states to create, adopt, and implement WIPO Standard ST.26 
for sequence listing submissions in XML file format, which has the 
INSDC data elements to address the data loss. WIPO Standard ST.26 aims 
to enhance the accuracy and quality of biological sequence data that is 
publicly disseminated. With the adoption and implementation of WIPO 
Standard ST.26, more complete biological sequence data from patents and 
patent applications will be included in GenBank and thus be accessible 
by the

[[Page 30808]]

public. The change from American Standard Code for Information 
Interchange (ASCII) plain text format to XML format will result in 
sequence data having computer tags that facilitate sorting and 
retrieving and will permit ease of access to the data. Additionally, 
the NCBI plans to stop accepting data in Standard ST.25 format for 
inclusion in GenBank approximately three to five years after the WIPO 
Standard ST.26 transition date (July 1, 2022).

c. Incorporation by Reference of WIPO Standard ST.26

    The WIPO ``Handbook on Industrial Property Information and 
Documentation'' sets forth standards for the presentation of data in 
many contexts. WIPO Standard ST.26 is titled ``RECOMMENDED STANDARD FOR 
THE PRESENTATION OF NUCLEOTIDE AND AMINO ACID SEQUENCE LISTINGS USING 
XML (EXTENSIBLE MARKUP LANGUAGE).'' The CWS adopted the current version 
(version 1.5) in November of 2021. In October of 2021, at the 
Assemblies of Member States of WIPO, the member states agreed on July 
1, 2022, as the implementation date of WIPO Standard ST.26. This final 
rule incorporates by reference WIPO Standard ST.26. The standard is 
available from WIPO, 34 chemin des Colombettes, 1211 Geneva 20 
Switzerland, www.wipo.int. and also as provided for in 37 CFR 1.839.
    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 
Standard ST.25 format to WIPO Standard ST.26 format, including guidance 
on how to avoid adding or deleting subject matter.
    The main body of 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. As detailed in paragraph eight of the main 
body, a sequence listing in XML format must not include any sequences 
having fewer than 10 specifically defined nucleotides, or fewer than 4 
specifically defined amino acids. If such sequences are included in the 
disclosure, they must not be assigned a sequence identification number. 
The main body establishes the requirements for the representation of 
nucleotide and/or amino acid sequences and the requirements for the XML 
file format for a sequence listing. Annex I contains controlled 
vocabulary that provides nucleotide base codes, lists of modified 
nucleotides and their abbreviations, amino acid codes, and a list of 
modified amino acids and their abbreviations. In addition, Annex I 
provides defined feature keys and qualifiers used for nucleotide and/or 
amino acid sequences in the XML file for a sequence listing. Annex I 
specifically identifies qualifiers with language-dependent ``free 
text'' values that may require translation for national and regional 
procedures. Annex II provides the DTD setting forth the technical 
specifications to which a submitted Sequence Listing XML must conform. 
Annex III provides a link to a specimen of a sequence listing that is 
compliant with WIPO Standard ST.26 and that shows a representation of 
an entire sequence listing in XML format. Annex IV provides a table of 
the character subset from the Unicode Basic Latin Code that will be 
used in the XML file for the sequence listing. Annex V provides 
guidance to WIPO member states on how certain sequence elements should 
be populated when data is exchanged with database providers. Annex VI, 
containing the guidance document, ensures that all applicants and WIPO 
member states understand the requirements for inclusion and 
representation of sequence disclosures. This guidance document was 
developed, in part, to address concerns raised in response to the 
USPTO's requests for comments in 2012 and 2016, mentioned above. The 
guidance document illustrates the requirements of selected paragraphs 
in the main body of WIPO Standard ST.26 through specific examples of 
nucleotide and amino acid biological sequence data. Additionally, the 
document provides guidance on the manner in which biological sequence 
data is represented in a sequence listing in XML format that is 
compliant with WIPO Standard ST.26. Annex VII addresses the mandatory 
requirements of WIPO Standard ST.26, and the potential consequence of 
these requirements when transforming a compliant Standard ST.25 
sequence listing into a WIPO Standard ST.26 sequence listing. Annex VII 
also provides detailed guidance on how to avoid adding or deleting 
subject matter due to the additional requirements of WIPO Standard 
ST.26.

d. Benefits

    Transitioning from rules based on WIPO Standard ST.25 (i.e., the 
basis for USPTO rules 37 CFR 1.821 through 1.825, regarding ``Sequence 
Listings'') to rules based on WIPO Standard ST.26 will be beneficial to 
both patent applicants filing sequence listings and IPOs receiving 
applications containing disclosures of nucleotide and/or amino acid 
sequences requiring sequence listings. WIPO Standard ST.26 provides 
clear requirements for what must be included in a sequence listing and 
how sequences must be represented. For example, it standardizes the 
representation of modified nucleotide sequences and amino acid 
sequences as well as variants derived from primary sequences. Since 
WIPO Standard ST.26 contains a guidance document that illustrates the 
requirements for the inclusion and representation of biological 
sequence data, patent applicants will have a better understanding of 
the requirements for the presentation of biological sequence data in a 
compliant sequence listing under WIPO Standard ST.26 (as implemented by 
37 CFR 1.831 through 1.839). Additionally, since WIPO Standard ST.26 
only allows XML format (an electronic computer readable format), this 
final rule eliminates the potential for differences between a sequence 
listing filed in paper/PDF format and the required electronic computer 
readable format (CRF). As a further benefit, the IPOs of WIPO member 
states will no longer need to expend resources to process paper 
sequence listings and perform necessary checks on the contents of paper 
documents.
    Unlike rules based on Standard ST.25, rules based on WIPO Standard 
ST.26 will allow patent applicants to file a single sequence listing 
with the USPTO (with the exception of changes to comply with national 
language requirements) that will be acceptable to the IPOs of all WIPO 
member states. Under Standard ST.25, IPOs have interpreted and enforced 
rules differently due to the imprecise language in that standard. This 
has resulted in the frustrating situation in which applicants generate 
sequence listings that may be accepted in one IPO but not another.
    WIPO Standard ST.26 was drafted to precisely define what must and 
must not be included in a sequence listing

[[Page 30809]]

and how sequences must be represented in a sequence listing. The 
``Guidance document with illustrated examples'' in Annex VI of WIPO 
Standard ST.26 demonstrates the application of the rules to real-world 
sequence disclosure examples, reducing the possibility of 
misinterpretation by IPOs or applicants.
    Due to the improved data structure of XML, transitioning to rules 
based on WIPO Standard ST.26 will increase the quality of the 
examination of patent applications containing biological sequence data 
since a more comprehensive search will be possible. Sequence listings 
submitted in accordance with WIPO Standard ST.26 allow for targeted 
searching of both sequence annotation and newly required sequence 
types, such as D-amino acids, nucleotide analogues, and linear portions 
of branched sequences. Finally, sequence listing submissions under 
rules based on WIPO Standard ST.26 will enhance public database 
content, as they include the sequence annotations (e.g., feature keys 
and qualifiers) used by database providers to describe biological 
sequence data. WIPO Standard ST.26 standardizes sequence variant 
presentation, the annotation of modified and unusual residues, feature 
location descriptors, the use of feature keys and qualifiers, organism 
names, and the presentation of coding regions. Incorporation by 
reference of WIPO Standard ST.26 into USPTO rules promotes data 
exchange between the USPTO and the NCBI due to the use of INSDC 
identifiers required by database providers. The presence of additional 
data, as well as the enhanced compatibility to facilitate the exchange 
of data, will increase the value of database searches that relate to 
nucleotide and amino acid sequences for biotechnology stakeholders.
    Requiring compliance with WIPO Standard ST.26 for an application 
filed on or after July 1, 2022, will reduce the complexity and cost of 
the long-term maintenance of information technology (IT) systems for 
accepting sequence listings in multiple formats, provide a clear 
implementation date, and facilitate the transition to the format 
requirements of database providers. In addition, a requirement to 
submit a single sequence listing in XML format will result in better 
preservation, accessibility, and sorting of the submitted sequence data 
for the public.

e. WIPO Authoring and Validation Tool (WIPO Sequence)

    To comply with rules based on WIPO Standard ST.26, patent 
applicants will be able to generate a sequence listing compliant with 
WIPO Standard ST.26 using WIPO Sequence, a desktop application 
developed by WIPO and adopted by WIPO member states. WIPO Sequence has 
two functions: An authoring function and a validation function. Patent 
applicants will be able to author and validate their sequence listing 
using WIPO Sequence to comply with the requirements of WIPO Standard 
ST.26. Such a sequence listing will be accepted by all the IPOs of the 
WIPO member states. Thus, the burden of generating a sequence listing 
that is acceptable across all WIPO member states will be significantly 
decreased for patent applicants under WIPO Standard ST.26. This tool is 
downloadable, free of charge, from the WIPO website. The current 
version of WIPO Sequence is accessible at www.wipo.int/standards/en/sequence/index.html. This version, subject to updates, will allow the 
public to become familiar with the tool and its dual functionalities.
    WIPO Sequence will allow a user to create and save (author) patent 
application data and biological sequence data in a project, validate 
the project to ensure all required information is present, and generate 
a sequence listing in WIPO Standard ST.26 XML format. Information can 
be entered into a project manually, or data can be imported from a 
source file in one of a number of file types. WIPO Sequence can import 
data from other WIPO Standard ST.26 projects, WIPO Standard ST.26 XML 
sequence listings, Standard ST.25 sequence listing text files, raw 
files, multi-sequence format files, and FASTA (FAST-All-a DNA and 
protein sequence alignment software package) files. Feature keys, 
qualifiers, and organism names are available to select from drop-down 
lists, simplifying the creation of sequence listings. Applicant and 
inventor names, as well as custom organism names, can be stored in WIPO 
Sequence for easy access. To facilitate the review of data entered into 
a project, WIPO Sequence can generate a ``human-readable'' version (a 
text version of the sequence data) of the sequence listing in addition 
to the XML sequence listing.
    WIPO Sequence includes an integrated validation function that will 
alert users to most errors in a project or sequence listing data. The 
validation function generates a report that clearly lists every 
detected error, the location of the error, and the detected value of 
the error, along with a link to the sequence in question, thereby 
ensuring users can correct errors before generating a final sequence 
listing. While the validation function will alert a user to most errors 
in a project or sequence listing, there are a small number of errors 
that can be detected only by human review (for example, an 
inappropriate organism name). In those cases, the integrated validation 
function will list a ``warning'' in the validation report, reminding 
users of the applicable/relevant rule and urging them to check their 
input values before generating a final sequence listing.
    A sequence listing in Standard ST.25 format cannot automatically be 
converted into WIPO Standard ST.26 format because certain data elements 
required for a sequence listing compliant with WIPO Standard ST.26 are 
not present in Standard ST.25. Therefore, conversion of a sequence 
listing in Standard ST.25 format to Standard ST.26 format necessarily 
requires additional input from the applicant. WIPO Sequence, 
supplemented by significant guidance from WIPO and the USPTO (in Annex 
VI and Annex VII of WIPO Standard ST.26), will help applicants 
accomplish this task. Users can import a Standard ST.25 sequence 
listing into a project, and WIPO Sequence automatically performs many 
of the necessary conversions. An Import Report is generated that alerts 
the user to all data conversions and lists all sequence entries that 
require additional input. In response to concerns raised regarding the 
USPTO's requests for comments in 2012 and 2016, the USPTO, in 
conjunction with WIPO, developed Annex VII to provide detailed guidance 
to help applicants avoid added or deleted subject matter when 
converting a sequence listing from Standard ST.25 format into Standard 
ST.26 format.
    To ensure that IPOs can validate and accept sequence listing 
projects from applicants generated with WIPO Sequence, WIPO is 
developing a Standard ST.26 sequence listing validation tool, WIPO 
Sequence Validator. WIPO Sequence Validator will be for use by IPOs. 
WIPO Sequence Validator will be synchronized with the validation 
function in the WIPO Sequence tool. The USPTO is integrating WIPO 
Sequence Validator into its internal IT systems. The WIPO Sequence 
Validator will apply the same validation rules as WIPO Sequence. 
Therefore, filers will have a greater level of confidence that a 
sequence listing authored and validated by WIPO Sequence will comply 
with the USPTO rules for a ``Sequence Listing XML'' (37 CFR 1.831 
through 1.835) and be accepted, given that the WIPO Sequence Validator 
that the USPTO will use is based on WIPO Standard ST.26.

[[Page 30810]]

f. Applicability

    In accordance with this final rule, an application that has a 
filing date on or after July 1, 2022, will be required to provide a 
``Sequence Listing XML'' in accordance with 37 CFR 1.831 through 1.835 
for disclosures of any nucleotide and/or amino acid sequences that meet 
the definitions of 37 CFR 1.831(a) and (b). This includes applications 
having an international filing date on or after July 1, 2022, that 
claim benefit or priority to applications with filing dates before July 
1, 2022. Such applications include, but are not limited to, 
applications having one or more benefit or priority claims under 35 
U.S.C. 119(e) (claiming the benefit of a provisional), 35 U.S.C. 120 
(claiming the benefit as a continuation and/or continuation-in-part), 
35 U.S.C. 121 (claiming the benefit as a divisional), 35 U.S.C. 365(c) 
(claiming the benefit as a continuing application to a PCT 
application), or 35 U.S.C. 119(a)-(d) or 35 U.S.C. 365(a) (claiming the 
priority to a foreign filed application or a prior filed PCT). If a 
prior application to which benefit or priority is claimed contains a 
``Sequence Listing'' in Standard ST.25 format (in compliance with 37 
CFR 1.821 through 1.825), the applicant will be required to convert 
that ``Sequence Listing'' to WIPO Standard ST.26 format (a ``Sequence 
Listing XML'' in compliance with 37 CFR 1.831 through 1.835) for 
inclusion in the new application filed on or after July 1, 2022.
    As provided in 35 U.S.C. 363, the filing date of an international 
stage application is also the filing date for the national stage 
application filed under 35 U.S.C. 371. Accordingly, for applications 
submitted under 35 U.S.C. 371, WIPO Standard ST.26 will apply to such 
applications based on the international filing date of the 
corresponding international application, rather than the date of 
submission of the national stage application in the USPTO.
    Compliance with 37 CFR 1.831 through 1.835 (rules based on WIPO 
Standard ST.26) is also applicable to any reissue application filed on 
or after July 1, 2022, where the disclosure or claims contain 
nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(a) or 
(b). The filing date of the originally granted patent for which reissue 
is sought is not relevant in determining the applicability date of this 
final rule.
    Relying on the actual filing date of an application to determine 
whether sequence information must conform to 37 CFR 1.821 through 1.825 
(rules based on Standard ST.25) or 37 CFR 1.831 through 1.835 (rules 
based on WIPO Standard ST.26) will simplify the application of the 
sequence rules, both for the USPTO and the applicant. Though 37 CFR 
1.821 through 1.825 are not revised by this final rule, note that 37 
CFR 1.821 through 1.825 will not be applicable to applications filed on 
or after July 1, 2022, as a result of this final rule.
    For applications filed on or after July 1, 2022, the USPTO patent 
electronic filing system will prohibit an applicant from submitting 
both a ``Sequence Listing XML'' (a sequence listing that conforms to 
WIPO Standard ST.26 as implemented in 37 CFR 1.831 through 1.835) and a 
``Sequence Listing'' (a sequence listing that conforms to ST.25 as 
implemented in 37 CFR 1.821 through 1.825) in the same submission. 
Filing a ``Sequence Listing'' in an application filed on or after July 
1, 2022, will result in a notice informing applicant that the 
submission fails to comply with 37 CFR 1.831 through 1.834 and will 
require submission of a ``Sequence Listing XML.''
    While implementing regulations and procedures for ST.26, the USPTO 
recognized that an applicant might erroneously provide a ``Sequence 
Listing'' (one in ASCII plain text file format) even though a 
``Sequence Listing XML'' is required. Therefore, in the rare 
circumstance in which a ``Sequence Listing'' is submitted in an 
application filed on or after July 1, 2022, the ``Sequence Listing'' 
present in the Office file wrapper of the application at issue may be 
used to provide support for the submission of a compliant ``Sequence 
Listing XML.'' The applicant's reliance on the ``Sequence Listing'' to 
support the compliant ``Sequence Listing XML'' would be by way of the 
safeguard under 37 CFR 1.57(b), if an earlier filed application 
contains a proper ``Sequence Listing'' in .txt file format, or via a 
grantable petition under 37 CFR 1.182, only if the application does not 
have a proper benefit or priority claim present on the filing date to 
an earlier filed application.
    An applicant may rely on the provisions in 37 CFR 1.57(b), as 
described in the Manual of Patent Examining Procedure at section 217, 
to support the required ``Sequence Listing XML'' as an ``inadvertently 
omitted portion of the specification or drawing(s).'' To rely on 37 CFR 
1.57(b), a compliant ``Sequence Listing'' must have been submitted in 
an earlier filed application to which the present application makes a 
proper benefit or priority claim, and the ``Sequence Listing'' was 
present on the filing date of the earlier filed application (i.e., the 
earlier filed application contains a compliant ``Sequence Listing'' 
submitted under 37 CFR 1.821(c)(1) as an ASCII plain text file (with a 
proper incorporation by reference statement in the specification), 37 
CFR 1.821(c)(2) as a PDF copy, or 37 CF 1.821(c)(3) on physical sheets 
of paper). An applicant would be required to submit: (1) A compliant 
``Sequence Listing XML'' under 37 CFR 1.835(a)(1); (2) a statement 
identifying where the inadvertently omitted portion of the 
specification can be found (e.g., identifying the nucleotide and/or 
amino acid sequence information in the compliant ``Sequence Listing'' 
from the earlier filed application that forms the basis for the 
``Sequence Listing XML''), see 37 CFR 1.835(a)(3); (3) a statement 
identifying the nucleotide and/or amino acid sequences of the 
``Sequence Listing,'' submitted (in the earlier filed application) 
under 37 CFR 1.821(c)(1) as an ASCII plain text file (with a proper 
incorporation by reference statement in the specification), 37 CFR 
1.821(c)(2) as a PDF copy, or 37 CFR 1.821(c)(3) as physical sheets of 
paper, which forms the basis for the compliant ``Sequence Listing 
XML''; (4) a statement that the ``Sequence Listing XML'' does not 
introduce new matter into the application, see 37 CFR 1.835(a)(4); and 
(5) a statement that all or a portion of the specification or drawings, 
as found in the ``Sequence Listing XML,'' were inadvertently omitted 
from the application. The availability of relief under 37 CFR 1.57(b) 
precludes the filing of a grantable petition under 37 CFR 1.182 seeking 
the same relief.
    A petition under 37 CFR 1.182 would require: (1) A compliant 
``Sequence Listing XML'' under 37 CFR 1.835(a)(1); (2) a statement 
identifying the nucleotide and/or amino acid sequence information of 
the ``Sequence Listing'' submitted as an ASCII plain text file that 
forms the basis for the ``Sequence Listing XML'' (i.e., identifying the 
nucleotide and/or amino acid sequence information found in the 
``Sequence Listing'' from the earlier submitted ASCII ``Sequence 
Listing'') that is relied on for submission of a compliant ``Sequence 
Listing XML,'' see 37 CFR 1.835(a)(3); and (3) a statement that the 
``Sequence Listing XML'' does not introduce new matter into the 
application, as required by 37 CFR 1.835(a)(4). In such circumstances, 
for record retention purposes, any ``Sequence Listing'' submitted as an 
ASCII plain text file will be retained in the official record for the 
application.

[[Page 30811]]

II. Discussion of Specific Rules

    Section 1.52: Section 1.52 (e)(1)(ii) is amended to include 
reference to a ``Sequence Listing XML'' submitted under Sec.  1.831(a) 
in compliance with Sec. Sec.  1.832 through 1.834.
    Section 1.52(e)(3)(iii) is amended to more explicitly indicate that 
the contents of each read-only optical disc must be in ASCII plain text 
and if compressed, must be compressed in accordance with Sec.  1.58 for 
``Large Tables,'' Sec.  1.96 for a ``Computer Program Listing 
Appendix,'' or Sec.  1.824 for a ``Sequence Listing'' or CRF of the 
``Sequence Listing,'' as applicable.
    Section 1.52(e)(3)(iv) is added to require that the contents of 
each read-only optical disc for a ``Sequence Listing XML'' must be in 
XML file format and, if compressed, must be compressed in accordance 
with Sec.  1.834.
    Section 1.52(e)(7) is amended to add that any amendment to the 
information on a read-only optical disc previously submitted in 
relation to a ``Sequence Listing XML'' must be made by way of a 
replacement read-only optical disc in accordance with Sec.  1.835(b).
    Section 1.52(f)(1) is amended to add that any XML file submitted on 
a read-only optical disc is excluded from the application size fee 
determination if the read-only optical disc contains a ``Sequence 
Listing XML'' in compliance with Sec.  1.831(a). The provision at 35 
U.S.C. 41(a)(1)(G) provides the basis for excluding ``any sequence 
listing,'' when filed in electronic medium, from the application size 
fee determination. A ``Sequence Listing XML'' is considered as ``any 
sequence listing.''
    Section 1.52(f)(1)(i) is amended to reference any ``Sequence 
Listing XML'' in compliance with Sec.  1.831(a).
    Section 1.52(f)(2) is amended to indicate that any XML file, 
submitted via the USPTO patent electronic filing system for a 
``Sequence Listing XML'' in compliance with Sec.  1.831(a) is excluded 
from the application size fee determination. The provision at 35 U.S.C. 
41(a)(1)(G) provides the basis for excluding ``any sequence listing,'' 
when filed in an electronic medium, from the application size fee 
determination. A ``Sequence Listing XML'' is considered as ``any 
sequence listing.''
    Section 1.52(f)(2)(i) is amended to add a reference to any 
``Sequence Listing XML'' in compliance with Sec.  1.831(a).
    Section 1.52(f)(3) is amended to add that any ``Sequence Listing 
XML'' of 300 MB-800 MB is subject to the surcharge set forth in Sec.  
1.21(o)(1) and also add that any ``Sequence Listing XML'' over 800 MB 
is subject to the surcharge set forth in Sec.  1.21(o)(2).
    Section 1.53: Section 1.53(c)(4) is revised to indicate that a 
separate sequence listing in a provisional application disclosing 
nucleotide and/or amino acid sequences is not required, but any 
biological sequence data submitted in a provisional application filed 
on or after July 1, 2022, must be a ``Sequence Listing XML'' in 
compliance with Sec. Sec.  1.831 through 1.834. This change does not 
apply to provisional applications filed before July 1, 2022.
    Section 1.77: Section 1.77(b)(5) is amended to reorganize the 
provisions to Sec.  1.77(b)(5)(i) for an incorporation by reference 
statement for ASCII plain text files submitted for a ``Computer Program 
Listing Appendix'' (Sec.  1.77(b)(5)(i)(A)), a ``Sequence Listing'' 
(Sec.  1.77(b)(5)(i)(B)), and ``Large Tables'' (Sec.  
1.77(b)(5)(i)(C)). Section 1.77(b)(5)(ii) is added to provide for the 
provisions for an incorporation by reference statement for a ``Sequence 
Listing XML'' submitted via the USPTO patent electronic filing system 
or on one or more read-only optical discs.
    Section 1.121: Section 1.121(b) is amended to revise the reference 
for a ``Sequence Listing'' and eliminate the reference to a CRF of a 
``Sequence Listing,'' since a separate CRF (under Sec.  1.821(e)(1) or 
(2)) is not part of the specification. The amendment also adds an 
exception to amendment practice for a ``Sequence Listing XML'' (Sec.  
1.831(a)).
    Section 1.121(b)(6) is amended to require that changes to a 
``Sequence Listing XML'' be made in accordance with Sec.  1.835.
    Section 1.173: The heading of Sec.  1.173(b)(1) is amended to 
include `` `Sequence Listing XML' (Sec.  1.831(a)).''
    Section 1.173(b)(1)(i) is amended to add an exception to reissue 
amendment practice for a `` `Sequence Listing XML' (Sec.  1.831(a)).''
    Section 1.173(b)(1)(ii) is amended to provide that changes to a 
``Sequence Listing XML'' must be made in accordance with Sec.  1.835.
    Section 1.173(d) is amended to add a ``Sequence Listing XML'' 
(Sec.  1.831(a)) among the items that are excluded from the manner of 
making amendments in a reissue application. Reference to specific CFR 
provisions for ``Large Tables'' (Sec.  1.58(c)), a ``Computer Program 
Listing Appendix'' (Sec.  1.96(c)), and a ``Sequence Listing'' (Sec.  
1.821(c)) were added.
    Section 1.211: Section 1.211(c) is amended to add a ``Sequence 
Listing'' in compliance with Sec. Sec.  1.821 through 1.825 (if 
applicable) for an application filed before July 1, 2022, and a 
``Sequence Listing XML'' in compliance with Sec. Sec.  1.831 through 
1.835 (if applicable) for an application filed on or after July 1, 
2022, to the currently listed items that may delay application 
publication if not present.
    Section 1.495: Section 1.495(c)(5) is amended to delineate between 
translations needed for a sequence listing in international 
applications entering the national stage in the United States and 
having an international filing date before July 1, 2022, and a sequence 
listing in XML format for international applications entering the 
national stage in the United States and having an international filing 
date on or after July 1, 2022. Specifically, the amendment indicates 
that a sequence listing need not be translated for national stage entry 
if it complies with PCT Rule 12.1(d) and the description complies with 
PCT Rule 5.2(b) for applications having an international filing date 
before July 1, 2022. However, the amendment indicates that a sequence 
listing in XML format must be translated for national stage entry if it 
was submitted in an international application having an international 
filing date on or after July 1, 2022, with non-English language values 
for any language-dependent free text qualifiers. Note that an invention 
title is not considered a ``language-dependent free text qualifier'' 
for purposes of this rule, and translation of the invention title is 
not required.
    Section 1.495(c)(5), as well as Sec. Sec.  1.833(b)(3) and 
1.835(d)(2) as discussed below, were proposed to require that the 
``Sequence Listing XML'' contain at least one invention title in 
English. This proposal has not been adopted in this final rule. The 
proposed requirement for a translation of the title into English was 
not adopted in the final rule because applicants in the international 
phase need only provide a title in the language of filing, which can be 
in a language other than English.
    Section 1.530: The heading of Sec.  1.530(d)(1) is amended to 
include `` `Sequence Listing XML' (Sec.  1.831(a)).''
    Section 1.530(d)(1)(i) is amended to add an exception to 
reexamination amendment practice for a `` `Sequence Listing XML' (Sec.  
1.831(a)).''
    Section 1.530(d)(1)(ii) is amended to provide that changes to a 
``Sequence Listing XML'' must be made in accordance with Sec.  1.835.
    Section 1.704: Section 1.704(f) is amended to add a ``Sequence 
Listing XML'' in compliance with Sec. Sec.  1.831 through 1.835 (if 
applicable) to the list of items required for an application filed 
under 35 U.S.C. 111(a) to be in condition for examination for purposes 
of calculating a reduction in patent term adjustment. The amendment 
also adds a ``Sequence Listing XML'' in compliance

[[Page 30812]]

with Sec. Sec.  1.831 through 1.835 (if applicable) to the list of 
items that must be submitted in an international application for such 
an application to be in condition for examination when the application 
has entered the national stage as defined in Sec.  1.491(b). Lastly, 
the rule is also amended to add a ``Sequence Listing XML'' in 
compliance with Sec. Sec.  1.831 through 1.835 (if applicable) to the 
current list of items required for an application to be considered 
compliant, for purposes of determining a patent term adjustment 
reduction, on the filing date of the latest reply (if any) correcting 
the papers, drawings, or ``Sequence Listing'' that is prior to the date 
of the mailing of either an action under 35 U.S.C. 132 or a notice of 
allowance under 35 U.S.C. 151, whichever occurs first. Lastly, the term 
``Sequence Listing'' replaces ``sequence listing,'' since Sec. Sec.  
1.821 through 1.825 specifically define a ``Sequence Listing.''
    Section 1.831: Section 1.831 is added to provide the heading of 
``requirements for patent applications filed on or after July 1, 2022, 
having disclosures of nucleotide and/or amino acid sequences.''
    Section 1.831(a) is added to specify that patent applications 
disclosing nucleotide and/or amino acid sequences by enumeration of 
their residues, as defined in paragraph (b) of the section, must 
contain, as a separate part of the disclosure, a ``Sequence Listing 
XML''. Disclosed nucleotide and/or amino acid sequences that do not 
meet the definition in paragraph (b) of the section must not be 
included in the ``Sequence Listing XML.'' The ``Sequence Listing XML'' 
contains information of the nucleotide and/or amino acid sequences 
disclosed in the patent application using the symbols and format in 
accordance with the requirements of Sec. Sec.  1.832 through 1.834.
    Section 1.831(b)(1) and (2) are added to define the nucleotide and 
amino acid sequences for which a ``Sequence Listing XML'' is required. 
Specifically, nucleotide and/or amino acid sequences, as used in these 
rules, encompass: an unbranched sequence or linear region of a branched 
sequence containing 4 or more specifically defined amino acids, wherein 
the amino acids form a single peptide backbone or an unbranched 
sequence or linear region of a branched sequence of 10 or more 
specifically defined nucleotides, wherein adjacent nucleotides are 
joined by a 3' to 5' (or 5' to 3') phosphodiester linkage or, for 
nucleotide analogs, any chemical bond that results in an arrangement of 
adjacent nucleobases that mimics the arrangement of nucleobases in 
naturally occurring nucleic acids.
    Section 1.831(c) is added to state that, where the description or 
claims of a patent application discuss a nucleotide and/or amino acid 
sequence that is set forth in the ``Sequence Listing XML'' in 
accordance with paragraph (a) of the section, reference must be made to 
the sequence by use of the sequence identifier, preceded by ``SEQ ID 
NO:'' or the like, in the text of the description or claims, even if 
the sequence is also embedded in the text of the description or claims 
of the patent application. Where a sequence is presented in a drawing, 
reference must be made to the sequence by use of the sequence 
identifier (Sec.  1.832(a)), either in the drawing or in the Brief 
Description of the Drawings, where the correlation between multiple 
sequences in the drawing and their sequence identifiers (Sec.  
1.832(a)) in the Brief Description is clear. The use of SEQ ID NO: Is 
preferred, but including ``or the like'' is intended to ensure that a 
formalities notice is not sent when an application uses, for example, 
``SEQ NO.'' or ``Seq. Id. No.'' or any similar identification of an 
amino acid or nucleotide sequence in the description or claims where it 
is clear that a sequence from the ``Sequence Listing XML'' is shown in 
the description, claims, or drawings. When identifying the sequence in 
the description, claims, or drawings, the numeric sequence identifier 
from the ``Sequence Listing XML'' must identify the same sequence.
    Section 1.831(d) is added to define the expression ``enumeration of 
its residues,'' consistent with the definition in paragraph 3(c)(i) or 
(ii) of WIPO Standard ST.26 (incorporated by reference, see 37 CFR 
1.839).
    Section 1.831(e) is added to define the expression ``specifically 
defined,'' consistent with the definition in paragraph 3(k) of WIPO 
Standard ST.26.
    Section 1.831(f) is added to define the expression ``amino acid,'' 
consistent with the definition in paragraph 3(a) of WIPO Standard 
ST.26.
    Section 1.831(g) is added to define the expression ``modified amino 
acid,'' consistent with the definition in paragraph 3(e) of WIPO 
Standard ST.26.
    Section 1.831(h) is added to define the expression ``nucleotide,'' 
consistent with paragraphs 3(f) and 3(g) of WIPO Standard ST.26.
    Section 1.831(i) is added to define the expression ``modified 
nucleotide,'' consistent with paragraph 3(f) of WIPO Standard ST.26.
    Section 1.831(j) is added to indicate that a ``Sequence Listing 
XML'' must not include any sequences having fewer than 10 specifically 
defined nucleotides, or fewer than 4 specifically defined amino acids. 
Even though Sec.  1.831(a) states that ``[d]isclosed 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,'' 
'' adding Sec.  1.831(j) makes explicit the prohibition of including 
such sequences in the ``Sequence Listing XML.''
    Section 1.832: Section 1.832 is added to provide the manner in 
which a nucleotide and/or amino acid sequence is represented in the 
``Sequence Listing XML'' part of a patent application having a filing 
date on or after July 1, 2022.
    Section 1.832(a) is added to define the requirements for the 
representation of sequences in the ``Sequence Listing XML'' part of the 
application. Specifically, each nucleotide and/or amino acid sequence 
represented in the ``Sequence Listing XML'' must be assigned a separate 
sequence identifier, and sequence identifiers must begin with the 
number 1 and increase sequentially by integers, as defined in paragraph 
10 of WIPO Standard ST.26 (incorporated by reference, see 37 CFR 
1.839).
    Section 1.832(b)(1) through (4) are added to define the 
requirements for the representation of nucleotide sequence data in the 
``Sequence Listing XML.'' Specifically, a nucleotide sequence must be 
represented in the manner described in paragraphs 11-12 of WIPO 
Standard ST.26. All nucleotides, including nucleotide analogs, modified 
nucleotides, and ``unknown'' nucleotides, within a nucleotide sequence 
must be represented and described using symbols in the manner described 
in paragraphs 13-19 and 21 of WIPO Standard ST.26. For a region 
containing a known number of contiguous ``a,'' ``c,'' ``g,'' ``t,'' or 
``n'' residues for which the same description applies, the entire 
region may be jointly described as provided in paragraph 22 of WIPO 
Standard ST.26.
    Section 1.832(c)(1) through (4) are added to define the 
requirements for the representation of amino acid sequence data in the 
``Sequence Listing XML.'' Specifically, an amino acid sequence must be 
represented in the manner described in paragraphs 24 and 25 of WIPO 
Standard ST.26. All amino acids, including modified amino acids and 
``unknown'' amino acids, within an amino acid sequence must be 
represented and described using symbols in the manner described in 
paragraphs 26-30 and 32 of WIPO Standard ST.26. For a region containing 
a known number of contiguous ``X''

[[Page 30813]]

residues for which the same description applies, the entire region may 
be jointly described as provided in paragraph 34 of WIPO Standard 
ST.26.
    Section 1.832(d) is added to define the manner in which a single 
continuous sequence, derived from one or more non-contiguous segments 
of a larger sequence, or of segments from different sequences, must be 
represented in the ``Sequence Listing XML,'' as described in paragraph 
35 of WIPO Standard ST.26.
    Section 1.832(e) is added to define the manner in which a 
nucleotide and/or amino acid sequence that contains regions of 
specifically defined residues separated by one or more regions of 
contiguous ``n'' or ``X'' residues of specified length must be 
represented in the ``Sequence Listing XML,'' as described in paragraph 
36 of WIPO Standard ST.26.
    Section 1.832(f) is added to define the manner in which a 
nucleotide and/or amino acid sequence that contains regions of 
specifically defined residues separated by one or more gaps of an 
unknown or undisclosed number of residues must be represented in the 
``Sequence Listing XML,'' as described in paragraph 37 of WIPO Standard 
ST.26.
    Section 1.833: Section 1.833 is added to describe the requirements 
for a ``Sequence Listing XML,'' which is required by Sec.  1.831(a) for 
disclosures of nucleotides and/or amino acid sequences in patent 
applications with a filing date on or after July 1, 2022, to comply 
with WIPO Standard ST.26 (incorporated by reference, see 37 CFR 1.839).
    Section 1.833(a) is added to require that the ``Sequence Listing 
XML'' must be presented as a single XML 1.0 file and encoded using 
Unicode UTF-8. Section 1.833(a) also incorporates by reference 
paragraphs 40 and 41, and Annex IV of WIPO Standard ST.26 for character 
sets.
    Section 1.833(b)(1) is added to require that the ``Sequence Listing 
XML'' presented in accordance with Sec.  1.833(a) must further be valid 
according to the DTD as presented in Annex II of WIPO Standard ST.26.
    Section 1.833(b)(2) is added to recite that a ``Sequence Listing 
XML'' must comply with the requirements of WIPO Standard ST.26, to 
include the items enumerated in Sec.  1.833(b)(2)(i) through (v) as 
discussed in the following paragraphs.
    Section 1.833(b)(2)(i) is added to require that the ``Sequence 
Listing XML'' contain an XML declaration as defined in paragraph 39(a) 
of WIPO Standard ST.26.
    Section 1.833(b)(2)(ii) is added to require that the ``Sequence 
Listing XML'' contain a document type declaration as defined in 
paragraph 39(b) of WIPO Standard ST.26.
    Section 1.833(b)(2)(iii) is added to require that the ``Sequence 
Listing XML'' contain a root element as defined in paragraph 43 of WIPO 
Standard ST.26.
    Section 1.833(b)(2)(iv) is added to require that the ``Sequence 
Listing XML'' contain a general information part that complies with 
paragraphs 45, 47, and 48 of WIPO Standard ST.26, as applicable.
    Section 1.833(b)(2)(v) is added to require that the ``Sequence 
Listing XML'' contain a sequence data part that complies with 
paragraphs 50-55, 57, 58, 60-69, 71-78, 80-87, 89-98, and 100 of WIPO 
Standard ST.26, as applicable.
    Section 1.833(b)(3) is added to require that an INSDQualifier_value 
element includes a value for that element in English for each language-
dependent free text qualifier in the ``Sequence Listing XML,'' as 
required by Sec.  1.52(b)(1)(ii), and where an INSDQualifier_value 
element is defined in paragraphs 76 and 85-87 of WIPO Standard ST.26. 
The proposed requirement for a translation of the title into English 
was not adopted in the final rule because applicants in the 
international phase need only provide a title in the language of 
filing, which can be in a language other than English.
    Section 1.834: Section 1.834 is added to provide details on the 
form and format for nucleotide and/or amino acid sequence submissions 
as the ``Sequence Listing XML'' in patent applications filed on or 
after July 1, 2022.
    Section 1.834(a) is added to indicate that a ``Sequence Listing 
XML'' in Unicode UTF-8 created by any means (e.g., text editors, 
nucleotide/amino acid sequence editors, or other custom computer 
programs) in accordance with Sec. Sec.  1.831 through 1.833 must: (1) 
Be compatible with a PC or Mac[supreg] and with MS-DOS[supreg], MS-
Windows[supreg], Mac OS[supreg], or Unix[supreg]/Linux[supreg] 
operating systems; (2) be in XML format, where all permitted printable 
characters (including the space character) and non-printable (control) 
characters are defined in paragraph 40 of WIPO Standard ST.26 
(incorporated by reference, see 37 CFR 1.839); and (3) be named as 
*.xml, where ``*'' is one character or a combination of characters 
limited to upper- or lowercase letters, numbers, hyphens, and 
underscores and the name does not exceed 60 characters in total, 
excluding the extension. No spaces or other types of characters are 
permitted in the file name.
    Section 1.834(b) is added to require that the ``Sequence Listing 
XML'' must be in a single file containing the sequence information and 
be submitted either: (1) Electronically via the USPTO patent electronic 
filing system, where the file size must not exceed 100 MB and file 
compression is not permitted; or (2) on read-only optical disc(s) in 
compliance with Sec.  1.52(e), where (i) a file that is not compressed 
must be contained on a single read-only optical disc, (ii) the file may 
be compressed using WinZip[supreg], 7-Zip, or Unix[supreg]/
Linux[supreg] Zip, (iii) a compressed file must not be self-extracting, 
and (iv) a compressed XML file that does not fit on a single read-only 
optical disc may be split into multiple file parts in accordance with 
the target read-only optical disc size and labeled in compliance with 
Sec.  1.52(e)(5)(vi).
    Section 1.834(c)(1) is added to require that when a ``Sequence 
Listing XML'' required by Sec.  1.831(a) is submitted in XML file 
format via the USPTO patent electronic filing system or on a read-only 
optical disc (in compliance with Sec.  1.52(e)), the specification must 
contain a statement in a separate paragraph (see Sec.  1.77(b)(5)) that 
incorporates by reference the material in the XML file identifying: (1) 
The name of the file, (2) the date of creation, and (3) the size of the 
file in bytes, so long as Sec.  1.834(c)(2) does not apply. This 
provision was added in the final rule to expressly require an 
incorporation by reference statement in the specification to the 
``Sequence Listing XML,'' which was only implicitly required by Sec.  
1.835(c).
    Section 1.834(c)(2) is added to indicate that if the ``Sequence 
Listing XML'' required by Sec.  1.831(a) is submitted in XML file 
format via the USPTO patent electronic filing system or on a read-only 
optical disc (in compliance with Sec.  1.52(e)) for an international 
application during the international stage, then an incorporation by 
reference statement of the material in the XML file is not required. 
This provision was added in the final rule to specifically exempt the 
requirement for an incorporation by reference statement in the 
specification to the ``Sequence Listing XML'' (as in Sec.  1.834(c)(1)) 
for a national stage application when the ``Sequence Listing XML'' 
constituted part of the international application during the 
international stage.
    Section 1.835: Section 1.835 is added to provide the requirements 
for submission of an amendment to add or replace a ``Sequence Listing 
XML'' for applications filed on or after July 1, 2022.

[[Page 30814]]

    Section 1.835(a) is added to require that any amendment to a patent 
application adding an initial submission of a ``Sequence Listing XML'' 
as required by Sec.  1.831(a) after the application filing date must 
include: (1) A ``Sequence Listing XML'' file submitted either (i) via 
the USPTO patent electronic filing system, or (ii) on a read-only 
optical disc in compliance with Sec.  1.52(e); (2) a request to amend 
the specification to include an incorporation by reference statement of 
the material in the ``Sequence Listing XML'' file, identifying the name 
of the file, the date of creation, and the size of the file in bytes 
(see Sec.  1.77(b)(5)(ii)), except when submitted to the United States 
International Preliminary Examining Authority for an international 
application; (3) a statement that indicates the basis for the 
amendment, with specific references to particular parts of the 
application as originally filed (specification, claims, drawings) for 
all sequence data in the ``Sequence Listing XML''; and (4) a statement 
that the ``Sequence Listing XML'' includes no new matter.
    Section 1.835(b) is added to require that any amendment adding to, 
deleting from, or replacing sequence information in a ``Sequence 
Listing XML'' submitted as required by Sec.  1.831(a) must include: (1) 
A replacement ``Sequence Listing XML'' containing the entire ``Sequence 
Listing XML,'' including any additions, deletions, or replacements of 
sequence information, and shall be submitted either (i) via the USPTO 
patent electronic filing system, or (ii) on a read-only optical disc, 
in compliance with Sec.  1.52(e) labeled as ``REPLACEMENT MM/DD/YYYY'' 
(with the month, day, and year of creation indicated); (2) an 
instruction to amend the specification to include an incorporation by 
reference statement of the material in the replacement ``Sequence 
Listing XML'' file that identifies the name of the file, the date of 
creation, and the size of the file in bytes (see Sec.  1.77(b)(5)(ii)), 
except when the replacement ``Sequence Listing XML'' is submitted to 
the United States International Preliminary Examining Authority for an 
international application; (3) a statement that identifies the location 
of all additions, deletions, or replacements of sequence information 
relative to the replaced ``Sequence Listing XML''; (4) a statement that 
indicates the support for the additions, deletions, or replacements of 
the sequence information, with specific references to particular parts 
of the application as originally filed (specification, claims, 
drawings) for all amended sequence data in the replacement ``Sequence 
Listing XML''; and (5) a statement that the replacement ``Sequence 
Listing XML'' includes no new matter.
    Section 1.835(c) is added to require that the specification of a 
complete application with a ``Sequence Listing XML'' as required under 
Sec.  1.831(a), present on the application filing date but without an 
incorporation by reference of the material contained in the ``Sequence 
Listing XML'' file, must be amended to contain a separate paragraph 
incorporating by reference the material contained in the ``Sequence 
Listing XML'' file, in accordance with Sec.  1.77(b)(5)(ii), except for 
international applications.
    Section 1.835(d)(1) is added to provide that, when any of the 
requirements of Sec. Sec.  1.831 through 1.834 are not satisfied in an 
application under 35 U.S.C. 111(a) or in a national stage application 
under 35 U.S.C. 371, the applicant will be notified and given a period 
of time in which to comply with such requirements to prevent the 
abandonment of the application. This final rule indicates that, subject 
to Sec.  1.835(d)(2), any amendment to add or replace a ``Sequence 
Listing XML'' in response to a requirement under this paragraph must be 
submitted in accordance with the requirements of Sec.  1.835(a) through 
(c).
    Section 1.835(d)(2) is added to explicitly provide that compliance 
with Sec.  1.835(a) through (c) is not required for the submission of a 
``Sequence Listing XML'' that is solely an English translation of a 
previously submitted ``Sequence Listing XML'' that contains non-English 
values for any language-dependent free text elements (as per Sec.  
1.833(b)(3)). The required submission will be a translated ``Sequence 
Listing XML'' in compliance with Sec. Sec.  1.831 through 1.834. 
Updated values for attributes in the root element (Sec.  
1.833(b)(2)(iii)) or elements of the general information part (Sec.  
1.833(b)(2)(iv)) are not considered amendments for purposes of 
complying with Sec.  1.835(a) through (c). Even though Sec. Sec.  
1.52(b)(1)(ii) and 1.495(c)(1)(i) require a translation for 
applications filed under 35 U.S.C. 111(a) and for those entering the 
national stage, respectively, this rule makes explicit that when a 
translated ``Sequence Listing XML'' is provided as a reply to a notice 
that the ``Sequence Listing XML'' contains non-English values for any 
language-dependent free text elements, and the translation does not 
include the deletion, addition, or replacement of sequence information, 
the translated ``Sequence Listing XML'' need not comply with the 
requirements for an amended ``Sequence Listing XML'' as set forth in 
Sec.  1.835(a) through (c). The proposed requirement for a translation 
of the title into English was not adopted in the final rule because 
applicants in the international phase need only provide a title in the 
language of filing, which can be in a language other than English.
    Section 1.835(e) is added to provide that, when any of the 
requirements of Sec. Sec.  1.831 through 1.834 are not satisfied at the 
time of filing an international application under the PCT, where the 
application is to be searched by the United States International 
Searching Authority or examined by the United States International 
Preliminary Examining Authority, the applicant may be sent a notice 
calling for compliance with the requirements within a prescribed time 
period. Under PCT Rule 13ter, the applicant may provide, in response to 
such a requirement or otherwise, a sequence listing that is a 
``Sequence Listing XML'' in accordance with Sec.  1.831(a). The 
``Sequence Listing XML'' must be accompanied by a statement that the 
information recorded does not go beyond the disclosure in the 
international application as filed. In response to such a requirement, 
the late furnishing fee set forth in Sec.  1.445(a)(5) is also 
required. If the applicant fails to timely provide the required 
``Sequence Listing XML,'' the United States International Searching 
Authority shall search only to the extent that a meaningful search can 
be performed without the ``Sequence Listing XML,'' and the United 
States International Preliminary Examining Authority shall examine only 
to the extent that a meaningful examination can be performed without 
the ``Sequence Listing XML.''
    Section 1.835(f) is added to provide that any appropriate 
amendments to the ``Sequence Listing XML'' in a patent (e.g., by reason 
of reissue, reexamination, or certificate of correction) must comply 
with the requirements of paragraph (b) of this section.
    Section 1.839: Section 1.839 is added to provide the location of 
WIPO Standard ST.26 that is being incorporated by reference.

III. Comments and Responses and Changes From Proposed Rule

    The USPTO published a proposed rule on July 6, 2021, at 86 FR 
35432, soliciting public comments on the proposed amendments to 37 CFR 
part 1 being adopted in this final rule. The USPTO received no comments 
from the public on the proposed rule. Even though no comments were 
received, the

[[Page 30815]]

proposed changes to Sec. Sec.  1.495(c)(5), 1.833(b)(3) and 1.835(d)(2) 
to require a title in English in the ``Sequence Listing XML'' were not 
adopted in the final rule. The proposed requirement for a translation 
of the title into English was not adopted since applicants in the 
international phase need only provide a title in the language of 
filing, which can be in a language other than English. Additionally, 
even though Sec.  1.831(a) states that ``[d]isclosed 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,'' 
'' Sec.  1.831(j) was added to make explicit the prohibition of 
including such sequences in the ``Sequence Listing XML.'' Section 
1.834(c)(1) was added to expressly require an incorporation by 
reference statement in the specification to the ``Sequence Listing 
XML,'' which was only implicitly required by Sec.  1.835(c). Lastly, 
Sec.  1.834(c)(2) was added to specifically exempt the requirement for 
an incorporation by reference statement in the specification to the 
``Sequence Listing XML'' (as in Sec.  1.834(c)(1)) for a national stage 
application when the ``Sequence Listing XML'' constituted part of the 
international application during the international stage.

IV. 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 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 
notice, the Senior Counsel for Regulatory and Legislative Affairs of 
the USPTO has certified to the Chief Counsel for Advocacy of the Small 
Business Administration that this rule will not have a significant 
economic impact on a substantial number of small entities. See 5 U.S.C. 
605(b).
    The USPTO amends the rules of practice to require the submission of 
biological sequence data in XML where the rules of practice incorporate 
by reference WIPO 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 1.5, 
approved November 5, 2021, as disclosed in the WIPO Handbook on 
Industrial Property Information and Documentation.
    This rulemaking makes more technical data associated with 
biotechnology inventions available to the public because the new rules 
of practice based on WIPO Standard ST.26 provide for enhanced 
biological sequence data related to disclosures of nucleotide and/or 
amino acid sequences in patent applications. WIPO Standard ST.26 
provides clear rules as to what must be included in a sequence listing 
and how sequences must be represented (e.g., standardization of the 
representation of modified nucleic acids and amino acids as well as 
variants derived from primary sequences). WIPO Standard ST.26 contains 
a guidance document that demonstrates the requirement for inclusion and 
representation of biological sequence data. As a result, patent 
applicants will have a clearer understanding as to the requirements and 
presentation of biological sequence data in a compliant sequence 
listing under WIPO Standard ST.26. Additionally, since WIPO Standard 
ST.26 only allows XML format, applicants will not be burdened with or 
confused by the requirements of filing a sequence listing in paper or 
PDF format, and IPOs will not be burdened with processing paper 
sequence listings and performing necessary checks on the contents of 
the paper documents. The changes in this rulemaking are largely 
procedural in nature, and do not impose any additional requirements or 
fees on applicants. For the foregoing reasons, the changes in this rule 
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, 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 applicable standards to minimize

[[Page 30816]]

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 affect 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 (44 U.S.C. 3501-3549) 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 majority of the paperwork and other information 
collection burdens discussed in this rule have already been approved 
under the following Office of Management and Budget (OMB) Control 
Numbers: 0651-0024 (Sequence Listing), 0651-0031 (Patent Processing), 
0651-0032 (Initial Patent Applications), and 0651-0064 (Patent 
Reexaminations and Supplemental Examinations).
    Modifications to 0651-0024 because of this rulemaking will be 
submitted to OMB for approval. Modifications include the removal of the 
Sequence Listing in Application (paper), which will result in an 
estimated reduction in the burden associated with this information 
collection by 5,000 responses and 30,000 burden hours. These burden 
estimates are based on the current OMB approved burdens (response 
volumes) associated with this information collection, which may be 
different from any forecasts mentioned in other parts of this rule.
    The changes discussed in this rule do not affect the information 
collection requirements or burdens associated with 0651-0031, 0651-
0032, and 0651-0064 listed above; therefore, the USPTO does not plan to 
take any additional actions on these information collections as a 
result of this rulemaking. 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. Section 1.52 is amended by:
0
a. Revising paragraphs (e)(1)(ii) and (e)(3)(ii) and (iii);
0
b. Adding paragraph (e)(3)(iv); and
0
c. Revising paragraphs (e)(7), (f)(1) introductory text, (f)(1)(i), 
(f)(2) introductory text, (f)(2)(i), and (f)(3).
    The revisions and addition read as follows:


Sec.  1.52   Language, paper, writing, margins, read-only optical disc 
specifications.

* * * * *
    (e) * * *
    (1) * * *
    (ii) A ``Sequence Listing'' (submitted under Sec.  1.821(c) in 
compliance with Sec. Sec.  1.822 through 1.824) or a ``Sequence Listing 
XML'' (submitted under Sec.  1.831(a) in compliance with Sec. Sec.  
1.832 through 1.834); or
* * * * *
    (3) * * *
    (ii) Operating system compatibility: MS-DOS[supreg], MS-
Windows[supreg], MacOS[supreg], or Unix[supreg]/Linux[supreg];
    (iii) The contents of each read-only optical disc must be in 
American Standard Code for Information Interchange (ASCII) plain text 
and if compressed, must be compressed in accordance with Sec.  1.58 for 
``Large Tables,'' with Sec.  1.96 for a ``Computer Program Listing 
Appendix,'' or Sec.  1.824 for a ``Sequence Listing'' or Computer 
Readable Form (CRF) of the ``Sequence Listing,'' as applicable; and
    (iv) The contents of each read-only optical disc for a ``Sequence 
Listing XML'' must be in eXtensible Markup Language (XML) file format, 
and if compressed, must be compressed in accordance with Sec.  1.834.
* * * * *
    (7) Any amendment to the information on a read-only optical disc 
must be by way of a replacement read-only optical disc, in compliance 
with Sec.  1.58(g) for ``Large Tables,'' Sec.  1.96(c)(5) for a 
``Computer Program Listing Appendix,'' Sec.  1.825(b) for a ``Sequence 
Listing'' or CRF of a ``Sequence Listing,'' and Sec.  1.835(b) for a 
``Sequence Listing XML.''
* * * * *

[[Page 30817]]

    (f) * * *
    (1) Submission on read-only optical discs. The application size fee 
required by Sec.  1.16(s) or Sec.  1.492(j), for an application 
component submitted in part on a read-only optical disc in compliance 
with paragraph (e) of this section, shall be determined such that each 
three kilobytes of content submitted on a read-only optical disc shall 
be counted as a sheet of paper. Excluded from this determination is any 
ASCII plain text file or any XML file (as applicable) submitted on a 
read-only optical disc under paragraph (e) of this section containing:
    (i) Any ``Sequence Listing'' or CRF of a ``Sequence Listing'' in 
compliance with Sec.  1.821(c) or (e), or any ``Sequence Listing XML'' 
in compliance with Sec.  1.831(a); or
* * * * *
    (2) Submission via the USPTO patent electronic filing system. The 
application size fee required by Sec.  1.16(s) or Sec.  1.492(j), for 
an application submitted in whole or in part via the USPTO patent 
electronic filing system, shall be determined such that the paper size 
equivalent will be considered to be 75% of the number of sheets of 
paper present in the specification and drawings for the application 
when entered into the Office records after being rendered by the USPTO 
patent electronic filing system. Excluded from this determination is 
any ASCII plain text file or any XML file (as applicable) submitted via 
the USPTO patent electronic filing system containing:
    (i) Any ``Sequence Listing'' or CRF of a ``Sequence Listing'' in 
compliance with Sec.  1.821(c)(1) or (e), or any ``Sequence Listing 
XML'' in compliance with Sec.  1.831(a); or
* * * * *
    (3) Oversized submission. Any submission of a ``Sequence Listing'' 
in electronic form or a ``Sequence Listing XML'' of 300 MB-800 MB filed 
in an application under 35 U.S.C. 111 or 371 will be subject to the fee 
set forth in Sec.  1.21(o)(1). Any submission of a ``Sequence Listing'' 
in electronic form or a ``Sequence Listing XML'' that exceeds 800 MB 
filed in an application under 35 U.S.C. 111 or 371 will be subject to 
the fee set forth in Sec.  1.21(o)(2).

0
3. Section 1.53 is amended by revising paragraph (c)(4) to read as 
follows:


Sec.  1.53   Application number, filing date, and completion of 
application.

* * * * *
    (c) * * *
    (4) A provisional application is not entitled to the right of 
priority under 35 U.S.C. 119, 365(a), or 386(a) or Sec.  1.55, or to 
the benefit of an earlier filing date under 35 U.S.C. 120, 121, 365(c), 
or 386(c) or Sec.  1.78 of any other application. No claim for priority 
under 35 U.S.C. 119(e) or Sec.  1.78(a) may be made in a design 
application based on a provisional application. A provisional 
application disclosing nucleotide and/or amino acid sequences is not 
required to include a separate sequence listing; however, if submitted 
in a provisional application filed on or after July 1, 2022, any 
submission of nucleotide and/or amino acid sequence data must be by way 
of a ``Sequence Listing XML'' in compliance with Sec. Sec.  1.831 
through 1.834.
* * * * *

0
4. Section 1.77 is amended by revising paragraph (b)(5) to read as 
follows:


Sec.  1.77   Arrangement of application elements.

* * * * *
    (b) * * *
    (5) An incorporation by reference statement regarding the material 
in:
    (i) One or more ASCII plain text files, submitted via the USPTO 
patent electronic filing system or on one or more read-only optical 
discs (see Sec.  1.52(e)(8)), identifying the names of each file, the 
date of creation of each file, and the size of each file in bytes, for 
the following document types:
    (A) A ``Computer Program Listing Appendix'' (see Sec.  1.96(c));
    (B) A ``Sequence Listing'' (see Sec.  1.821(c)); or
    (C) ``Large Tables'' (see Sec.  1.58(c)).
    (ii) An XML file for a ``Sequence Listing XML'' (see Sec.  
1.831(a)), submitted via the USPTO patent electronic filing system or 
on one or more read-only optical discs (see Sec.  1.52(e)(8)), 
identifying the names of each file, the date of creation of each file, 
and the size of each file in bytes.
* * * * *

0
5. Section 1.121 is amended by revising paragraphs (b) introductory 
text and (b)(6) to read as follows:


Sec.  1.121   Manner of making amendments in applications.

* * * * *
    (b) Specification. Amendments to the specification, other than the 
claims, ``Large Tables'' (Sec.  1.58(c)), a ``Computer Program Listing 
Appendix'' (Sec.  1.96(c)(5) and (7)), a ``Sequence Listing'' (Sec.  
1.825), or a ``Sequence Listing XML'' (Sec.  1.835), must be made by 
adding, deleting, or replacing a paragraph; by replacing a section; or 
by providing a substitute specification, in the manner specified in 
this section.
* * * * *
    (6) Amendments to ``Large Tables,'' a ``Computer Program Listing 
Appendix,'' a ``Sequence Listing,'' or a ``Sequence Listing XML.'' 
Changes to ``Large Tables,'' a ``Computer Program Listing Appendix,'' a 
``Sequence Listing,'' or a ``Sequence Listing XML'' must be made in 
accordance with Sec.  1.58(g) for ``Large Tables,'' Sec.  1.96(c)(5) 
for a ``Computer Program Listing Appendix,'' Sec.  1.825 for a 
``Sequence Listing,'' or Sec.  1.835 for a ``Sequence Listing XML.''
* * * * *

0
6. Section 1.173 is amended by revising paragraphs (b)(1) and (d) 
introductory text to read as follows:


Sec.  1.173   Reissue specification, drawings, and amendments.

* * * * *
    (b) * * *
    (1) Specification other than the claims, ``Large Tables'' (Sec.  
1.58(c)), a ``Computer Program Listing Appendix'' (Sec.  1.96(c)), a 
``Sequence Listing'' (Sec.  1.821(c)), or a ``Sequence Listing XML'' 
(Sec.  1.831(a)). (i) Changes to the specification, other than to the 
claims, ``Large Tables'' (Sec.  1.58(c)), a ``Computer Program Listing 
Appendix'' (Sec.  1.96(c)), a ``Sequence Listing'' (Sec.  1.821(c)), or 
a ``Sequence Listing XML'' (Sec.  1.831(a)), must be made by submission 
of the entire text of an added or rewritten paragraph, including 
markings pursuant to paragraph (d) of this section, except that an 
entire paragraph may be deleted by a statement deleting the paragraph, 
without presentation of the text of the paragraph. The precise point in 
the specification where any added or rewritten paragraph is located 
must be identified.
    (ii) Changes to ``Large Tables,'' a ``Computer Program Listing 
Appendix,'' a ``Sequence Listing,'' or a ``Sequence Listing XML'' must 
be made in accordance with Sec.  1.58(g) for ``Large Tables,'' Sec.  
1.96(c)(5) for a ``Computer Program Listing Appendix,'' Sec.  1.825 for 
a ``Sequence Listing,'' and Sec.  1.835 for a ``Sequence Listing XML.''
* * * * *
    (d) Changes shown by markings. Any changes relative to the patent 
being reissued that are made to the specification, including the claims 
but excluding ``Large Tables'' (Sec.  1.58(c)), a ``Computer Program 
Listing Appendix'' (Sec.  1.96(c)), a ``Sequence Listing'' (Sec.  
1.821(c)), and a ``Sequence Listing XML'' (Sec.  1.831(a)) upon filing 
or by an amendment paper in the reissue application, must include the 
following markings:
* * * * *

0
7. Section 1.211 is amended by revising paragraph (c) to read as 
follows:

[[Page 30818]]

Sec.  1.211   Publication of applications.

* * * * *
    (c) An application filed under 35 U.S.C. 111(a) will not be 
published until it includes the basic filing fee (Sec.  1.16(a) or (c)) 
and any English translation required by Sec.  1.52(d). The Office may 
delay publishing any application until it includes any application size 
fee required by the Office under Sec.  1.16(s) or Sec.  1.492(j), a 
specification having papers in compliance with Sec.  1.52 and an 
abstract (Sec.  1.72(b)), drawings in compliance with Sec.  1.84, a 
``Sequence Listing'' in compliance with Sec. Sec.  1.821 through 1.825 
(if applicable) for an application filed before July 1, 2022, a 
``Sequence Listing XML'' in compliance with Sec. Sec.  1.831 through 
1.835 (if applicable) for an application filed on or after July 1, 
2022, and the inventor's oath or declaration or application data sheet 
containing the information specified in Sec.  1.63(b).
* * * * *

0
8. Section 1.495 is amended by revising paragraph (c)(5) to read as 
follows:


Sec.  1.495   Entering the national stage in the United States of 
America.

* * * * *
    (c) * * *
    (5) For international applications having an international filing 
date before July 1, 2022, a sequence listing need not be translated if 
the sequence listing complies with PCT Rule 12.1(d) and the description 
complies with PCT Rule 5.2(b). For international applications having an 
international filing date on or after July 1, 2022, for purposes of 
paragraph (c)(1)(i) of this section, an English translation is required 
for any sequence listing in XML format (``Sequence Listing XML'') 
containing non-English language values for any language-dependent free 
text qualifiers in accordance with Sec. Sec.  1.831 through 1.834.
* * * * *

0
9. Section 1.530 is amended by revising paragraph (d)(1) to read as 
follows:


Sec.  1.530   Statement by patent owner in ex parte reexamination; 
amendment by patent owner in ex parte or inter partes reexamination; 
inventorship change in ex parte or inter partes reexamination.

* * * * *
    (d) * * *
    (1) Specification other than the claims, ``Large Tables'' (Sec.  
1.58(c)), a ``Computer Program Listing Appendix'' (Sec.  1.96(c)), a 
``Sequence Listing'' (Sec.  1.821(c)), or a ``Sequence Listing XML 
(Sec.  1.831(a)). (i) Changes to the specification, other than to the 
claims, ``Large Tables'' (Sec.  1.58(c)), a ``Computer Program Listing 
Appendix'' (Sec.  1.96(c)), a ``Sequence Listing'' (Sec.  1.821(c)), or 
a ``Sequence Listing XML'' (Sec.  1.831(a)), must be made by submission 
of the entire text of an added or rewritten paragraph, including 
markings pursuant to paragraph (f) of this section, except that an 
entire paragraph may be deleted by a statement deleting the paragraph, 
without presentation of the text of the paragraph. The precise point in 
the specification where any added or rewritten paragraph is located 
must be identified.
    (ii) Changes to ``Large Tables,'' a ``Computer Program Listing 
Appendix,'' a ``Sequence Listing,'' or a ``Sequence Listing XML'' must 
be made in accordance with Sec.  1.58(g) for ``Large Tables,'' Sec.  
1.96(c)(5) for a ``Computer Program Listing Appendix,'' Sec.  1.825 for 
a ``Sequence Listing,'' or Sec.  1.835 for a ``Sequence Listing XML.''
* * * * *

0
10. Section 1.704 is amended by revising paragraph (f) to read as 
follows:


Sec.  1.704   Reduction of period of adjustment of patent term.

* * * * *
    (f) An application filed under 35 U.S.C. 111(a) is in condition for 
examination when it includes a specification, including at least one 
claim and an abstract (Sec.  1.72(b)), and has papers in compliance 
with Sec.  1.52, drawings (if any) in compliance with Sec.  1.84, any 
English translation required by Sec.  1.52(d) or Sec.  1.57(a), a 
``Sequence Listing'' in compliance with Sec. Sec.  1.821 through 1.825 
(if applicable), a ``Sequence Listing XML'' in compliance with 
Sec. Sec.  1.831 through 1.835 (if applicable), an inventor's oath or 
declaration or an application data sheet containing the information 
specified in Sec.  1.63(b), the basic filing fee (Sec.  1.16(a) or 
(c)), the search fee (Sec.  1.16(k) or (m)), the examination fee (Sec.  
1.16(o) or (q)), any certified copy of the previously filed application 
required by Sec.  1.57(a), and any application size fee required by the 
Office under Sec.  1.16(s). An international application is in 
condition for examination when it has entered the national stage as 
defined in Sec.  1.491(b), and includes a specification, including at 
least one claim and an abstract (Sec.  1.72(b)), and has papers in 
compliance with Sec.  1.52, drawings (if any) in compliance with Sec.  
1.84, a ``Sequence Listing'' in compliance with Sec. Sec.  1.821 
through 1.825 (if applicable), a ``Sequence Listing XML'' in compliance 
with Sec. Sec.  1.831 through 1.835 (if applicable), an inventor's oath 
or declaration or an application data sheet containing the information 
specified in Sec.  1.63(b), the search fee (Sec.  1.492(b)), the 
examination fee (Sec.  1.492(c)), and any application size fee required 
by the Office under Sec.  1.492(j). An application shall be considered 
as having papers in compliance with Sec.  1.52, drawings (if any) in 
compliance with Sec.  1.84, and a ``Sequence Listing'' in compliance 
with Sec. Sec.  1.821 through 1.825 (if applicable), or a ``Sequence 
Listing XML'' in compliance with Sec. Sec.  1.831 through 1.835 (if 
applicable), for purposes of this paragraph (f) on the filing date of 
the latest reply (if any) correcting the papers, drawings, ``Sequence 
Listing,'' or ``Sequence Listing XML'' that is prior to the date of 
mailing of either an action under 35 U.S.C. 132 or a notice of 
allowance under 35 U.S.C. 151, whichever occurs first.

0
11. Sections 1.831 through 1.835 and 1.839 are added 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.
1.832 Representation of nucleotide and/or amino acid sequence data 
in the ``Sequence Listing XML'' part of a patent application filed 
on or after July 1, 2022.
1.833 Requirements for a ``Sequence Listing XML'' for nucleotide 
and/or amino acid sequences as part of a patent application filed on 
or after July 1, 2022.
1.834 Form and format for nucleotide and/or amino acid sequence 
submissions as the ``Sequence Listing XML'' in patent applications 
filed on or after July 1, 2022.
1.835 Amendment to add or replace a ``Sequence Listing XML'' in 
patent applications filed on or after July 1, 2022.
1.839 Incorporation by reference.
* * * * *


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 nucleotide and/or amino acid 
sequences by enumeration of their 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 sequences disclosed in 
the patent application using the symbols and format in accordance with 
the requirements of Sec. Sec.  1.832 through 1.834.

[[Page 30819]]

    (b) Nucleotide and/or amino acid sequences, as used in this section 
and Sec. Sec.  1.832 through 1.835, encompass:
    (1) An unbranched sequence or linear region of a branched sequence 
containing 4 or more specifically defined amino acids, wherein the 
amino acids form a single peptide backbone; or
    (2) An unbranched sequence or linear region of a branched sequence 
of 10 or more specifically defined nucleotides, wherein adjacent 
nucleotides are joined by:
    (i) A 3' to 5' (or 5' to 3') phosphodiester linkage; or
    (ii) Any chemical bond that results in an arrangement of adjacent 
nucleobases that mimics the arrangement of nucleobases in naturally 
occurring nucleic acids (i.e., nucleotide analogs).
    (c) Where the description or claims of a patent application discuss 
a sequence that is set forth in the ``Sequence Listing XML'' in 
accordance with paragraph (a) of this section, reference must be made 
to the sequence by use of the sequence identifier, preceded by ``SEQ ID 
NO:'' or the like in the text of the description or claims, even if the 
sequence is also embedded in the text of the description or claims of 
the patent application. Where a sequence is presented in a drawing, 
reference must be made to the sequence by use of the sequence 
identifier (Sec.  1.832(a)), either in the drawing or in the Brief 
Description of the Drawings, where the correlation between multiple 
sequences in the drawing and their sequence identifiers (Sec.  
1.832(a)) in the Brief Description is clear.
    (d) ``Enumeration of its residues'' means disclosure of a 
nucleotide or amino acid sequence in a patent application by listing, 
in order, each residue of the sequence, where the residues are 
represented in the manner as defined in paragraph 3(c)(i) or (ii) of 
WIPO Standard ST.26 (incorporated by reference, see Sec.  1.839).
    (e) ``Specifically defined'' means any amino acid or nucleotide as 
defined in paragraph 3(k) of WIPO Standard ST.26.
    (f) ``Amino acid'' includes any D- or L-amino acid or modified 
amino acid as defined in paragraph 3(a) of WIPO Standard ST.26.
    (g) ``Modified amino acid'' includes any amino acid as described in 
paragraph 3(e) of WIPO Standard ST.26.
    (h) ``Nucleotide'' includes any nucleotide, nucleotide analog, or 
modified nucleotide as defined in paragraphs 3(f) and 3(g) of WIPO 
Standard ST.26.
    (i) ``Modified nucleotide'' includes any nucleotide as described in 
paragraph 3(f) of WIPO Standard ST.26.
    (j) A ``Sequence listing XML'' must not include any sequences 
having fewer than 10 specifically defined nucleotides, or fewer than 4 
specifically defined amino acids.


Sec.  1.832   Representation of nucleotide and/or amino acid sequence 
data in the ``Sequence Listing XML'' part of a patent application filed 
on or after July 1, 2022.

    (a) Each disclosed nucleotide or amino acid sequence that meets the 
requirements of Sec.  1.831(b) must appear separately in the ``Sequence 
Listing XML.'' Each sequence set forth in the ``Sequence Listing XML'' 
must be assigned a separate sequence identifier. The sequence 
identifiers must begin with 1 and increase sequentially by integers as 
defined in paragraph 10 of WIPO Standard ST.26 (incorporated by 
reference, see Sec.  1.839).
    (b) The representation and symbols for nucleotide sequence data 
shall conform to the requirements of paragraphs (b)(1) through (4) of 
this section.
    (1) A nucleotide sequence must be represented in the manner 
described in paragraphs 11-12 of WIPO Standard ST.26.
    (2) All nucleotides, including nucleotide analogs, modified 
nucleotides, and ``unknown'' nucleotides, within a nucleotide sequence 
must be represented using the symbols set forth in paragraphs 13-16, 
19, and 21 of WIPO Standard ST.26.
    (3) Modified nucleotides within a nucleotide sequence must be 
described in the manner discussed in paragraphs 17, 18, and 19 of WIPO 
Standard ST.26.
    (4) A region containing a known number of contiguous ``a,'' ``c,'' 
``g,'' ``t,'' or ``n'' residues for which the same description applies 
may be jointly described in the manner described in paragraph 22 of 
WIPO Standard ST.26.
    (c) The representation and symbols for amino acid sequence data 
shall conform to the requirements of paragraphs (c)(1) through (4) of 
this section.
    (1) The amino acids in an amino acid sequence must be represented 
in the manner described in paragraphs 24 and 25 of WIPO Standard ST.26.
    (2) All amino acids, including modified amino acids and ``unknown'' 
amino acids, within an amino acid sequence must be represented using 
the symbols set forth in paragraphs 26-29 and 32 of WIPO Standard 
ST.26.
    (3) Modified amino acids within an amino acid sequence must be 
described in the manner discussed in paragraphs 29 and 30 of WIPO 
Standard ST.26.
    (4) A region containing a known number of contiguous ``X'' residues 
for which the same description applies may be jointly described in the 
manner described in paragraph 34 of WIPO Standard ST.26.
    (d) A nucleotide and/or amino acid sequence that is constructed as 
a single continuous sequence derived from one or more non-contiguous 
segments of a larger sequence or of segments from different sequences 
must be listed in the ``Sequence Listing XML'' in the manner described 
in paragraph 35 of WIPO Standard ST.26.
    (e) A nucleotide and/or amino acid sequence that contains regions 
of specifically defined residues separated by one or more regions of 
contiguous ``n'' or ``X'' residues, wherein the exact number of ``n'' 
or ``X'' residues in each region is disclosed, must be listed in the 
``Sequence Listing XML'' in the manner described in paragraph 36 of 
WIPO Standard ST.26.
    (f) A nucleotide and/or amino acid sequence that contains regions 
of specifically defined residues separated by one or more gaps of an 
unknown or undisclosed number of residues must be listed in the 
``Sequence Listing XML'' in the manner described in paragraph 37 of 
WIPO Standard ST.26.


Sec.  1.833   Requirements for a ``Sequence Listing XML'' for 
nucleotide and/or amino acid sequences as part of a patent application 
filed on or after July 1, 2022.

    (a) The ``Sequence Listing XML'' as required by Sec.  1.831(a) must 
be presented as a single file in XML 1.0 encoded using Unicode UTF-8, 
where the character set complies with paragraphs 40 and 41 and Annex IV 
of WIPO Standard ST.26 (incorporated by reference, see Sec.  1.839).
    (b) The ``Sequence Listing XML'' presented in accordance with 
paragraph (a) of this section must further:
    (1) Be valid according to the Document Type Definition (DTD) as 
presented in WIPO Standard ST.26, Annex II.
    (2) Comply with the requirements of WIPO Standard ST.26 to include:
    (i) An XML declaration as defined in paragraph 39(a) of WIPO 
Standard ST.26;
    (ii) A document type (DOCTYPE) declaration as defined in paragraph 
39(b) of WIPO Standard ST.26;
    (iii) A root element as defined in paragraph 43 of WIPO Standard 
ST.26;
    (iv) A general information part that complies with the requirements 
of paragraphs 45, 47, and 48, as applicable, of WIPO Standard ST.26; 
and
    (v) A sequence data part that complies with the requirements of 
paragraphs 50-55, 57, 58, 60-69, 71-78, 80-87, 89-98, and 100, as 
applicable, of WIPO

[[Page 30820]]

Standard ST.26 representing the nucleotide and/or amino acid sequences 
according to Sec.  1.832.
    (3) Include an INSDQualifier_value element with a value in English 
for any language-dependent free text qualifier as defined by paragraphs 
76 and 85-87 of WIPO Standard ST.26, and as required by Sec.  
1.52(b)(1)(ii).


Sec.  1.834   Form and format for nucleotide and/or amino acid sequence 
submissions as the ``Sequence Listing XML'' in patent applications 
filed on or after July 1, 2022.

    (a) A ``Sequence Listing XML'' encoded using Unicode UTF-8, created 
by any means (e.g., text editors, nucleotide/amino acid sequence 
editors, or other custom computer programs) in accordance with 
Sec. Sec.  1.831 through 1.833, must:
    (1) Have the following compatibilities:
    (i) Computer compatibility: PC or Mac[supreg]; and
    (ii) Operating system compatibility: MS-DOS[supreg], MS-
Windows[supreg], Mac OS[supreg], or Unix[supreg]/Linux[supreg].
    (2) Be in XML format, where all permitted printable characters 
(including the space character) and non-printable (control) characters 
are defined in paragraph 40 of WIPO Standard ST.26 (incorporated by 
reference, see Sec.  1.839).
    (3) Be named as *.xml, where ``*'' is one character or a 
combination of characters limited to upper- or lowercase letters, 
numbers, hyphens, and underscores, and the name does not exceed 60 
characters in total, excluding the extension. No spaces or other types 
of characters are permitted in the file name.
    (b) The ``Sequence Listing XML'' must be in a single file 
containing the sequence information and be submitted either:
    (1) Electronically via the USPTO patent electronic filing system, 
where the file size must not exceed 100 MB, and file compression is not 
permitted; or
    (2) On read-only optical disc(s) in compliance with Sec.  1.52(e), 
where:
    (i) A file that is not compressed must be contained on a single 
read-only optical disc;
    (ii) The file may be compressed using WinZip[supreg], 7-Zip, or 
Unix[supreg]/Linux[supreg] Zip;
    (iii) A compressed file must not be self-extracting; or
    (iv) A compressed XML file that does not fit on a single read-only 
optical disc may be split into multiple file parts, in accordance with 
the target read-only optical disc size, and labeled in compliance with 
Sec.  1.52(e)(5)(vi);
    (c)(1) Unless paragraph (c)(2) of this section applies, when the 
``Sequence Listing XML'' required by Sec.  1.831(a) is submitted in XML 
file format via the USPTO patent electronic filing system or on a read-
only optical disc (in compliance with Sec.  1.52(e)), then the 
specification must contain a statement in a separate paragraph (see 
Sec.  1.77(b)(5)) that incorporates by reference the material in the 
XML file identifying:
    (i) The name of the file;
    (ii) The date of creation; and
    (iii) The size of the file in bytes; or
    (2) If the ``Sequence Listing XML'' required by Sec.  1.831(a) is 
submitted in XML file format via the USPTO patent electronic filing 
system or on a read-only optical disc (in compliance with Sec.  
1.52(e)) for an international application during the international 
stage, then an incorporation by reference statement of the material in 
the XML file is not required.


Sec.  1.835   Amendment to add or replace a ``Sequence Listing XML'' in 
patent applications filed on or after July 1, 2022.

    (a) Any amendment to a patent application adding an initial 
submission of a ``Sequence Listing XML'' as required by Sec.  1.831(a) 
after the application filing date must include:
    (1) A ``Sequence Listing XML'' in accordance with Sec. Sec.  1.831 
through 1.834, submitted as an XML file:
    (i) Via the USPTO patent electronic filing system; or
    (ii) On a read-only optical disc, in compliance with Sec.  1.52(e);
    (2) A request to amend the specification to include an 
incorporation by reference statement of the material in the ``Sequence 
Listing XML'' file, identifying the name of the file, the date of 
creation, and the size of the file in bytes (see Sec.  1.77(b)(5)(ii)), 
except when submitted to the United States International Preliminary 
Examining Authority for an international application;
    (3) A statement that indicates the basis for the amendment, with 
specific references to particular parts of the application as 
originally filed (specification, claims, drawings) for all sequence 
data in the ``Sequence Listing XML''; and
    (4) A statement that the ``Sequence Listing XML'' includes no new 
matter.
    (b) Any amendment adding to, deleting from, or replacing sequence 
information in a ``Sequence Listing XML'' submitted as required by 
Sec.  1.831(a) must include:
    (1) A replacement ``Sequence Listing XML'' in accordance with the 
requirements of Sec. Sec.  1.831 through 1.834 containing the entire 
``Sequence Listing XML,'' including any additions, deletions, or 
replacements of sequence information, which shall be submitted:
    (i) Via the USPTO patent electronic filing system; or
    (ii) On a read-only optical disc, in compliance with Sec.  1.52(e), 
labeled as ``REPLACEMENT MM/DD/YYYY'' (with the month, day, and year of 
creation indicated);
    (2) A request to amend the specification to include an 
incorporation by reference statement of the material in the replacement 
``Sequence Listing XML'' file that identifies the name of the file, the 
date of creation, and the size of the file in bytes (see Sec.  
1.77(b)(5)(ii)), except when the replacement ``Sequence Listing XML'' 
is submitted to the United States International Preliminary Examining 
Authority for an international application;
    (3) A statement that identifies the location of all additions, 
deletions, or replacements of sequence information relative to the 
replaced ``Sequence Listing XML'';
    (4) A statement that indicates the support for the additions, 
deletions, or replacements of the sequence information, with specific 
references to particular parts of the application as originally filed 
(specification, claims, drawings) for all amended sequence data in the 
replacement ``Sequence Listing XML''; and
    (5) A statement that the replacement ``Sequence Listing XML'' 
includes no new matter.
    (c) The specification of a complete application, filed on the 
application filing date, with a ``Sequence Listing XML'' as required 
under Sec.  1.831(a), without an incorporation by reference of the 
material contained in the ``Sequence Listing XML'' file, must be 
amended to include a separate paragraph incorporating by reference the 
material contained in the ``Sequence Listing XML'' file, in accordance 
with Sec.  1.77(b)(5)(ii), except for international applications.
    (d)(1) If any of the requirements of Sec. Sec.  1.831 through 1.834 
are not satisfied in an application under 35 U.S.C. 111(a) or in a 
national stage application under 35 U.S.C. 371, the applicant will be 
notified and given a period of time within which to comply with such 
requirements in order to prevent abandonment of the application. 
Subject to paragraph (d)(2) of this section, any amendment to add or 
replace a ``Sequence Listing XML'' or add an incorporation by reference 
of the material contained in the ``Sequence Listing XML'' in response 
to a requirement under this paragraph (d)(1) must be submitted in 
accordance with the requirements of paragraphs (a) through (c) of this 
section.

[[Page 30821]]

    (2) Compliance with paragraphs (a) through (c) of this section is 
not required for submission of a ``Sequence Listing XML'' that is 
solely an English translation of a previously submitted ``Sequence 
Listing XML'' that contains non-English values for any language-
dependent free text elements (as per Sec.  1.833(b)(3)). The required 
submission will be a translated ``Sequence Listing XML'' in compliance 
with Sec. Sec.  1.831 through 1.834. Updated values for attributes in 
the root element (Sec.  1.833(b)(2)(iii)) or elements of the general 
information part (Sec.  1.833(b)(2)(iv)) are not considered amendments 
for purposes of complying with paragraphs (a) through (c) of this 
section.
    (e) If any of the requirements of Sec. Sec.  1.831 through 1.834 
are not satisfied at the time of filing an international application 
under the PCT, where the application is to be searched by the United 
States International Searching Authority or examined by the United 
States International Preliminary Examining Authority, the applicant may 
be sent a notice necessitating compliance with the requirements within 
a prescribed time period. Under PCT Rule 13ter, the applicant can 
provide, in response to such a requirement or otherwise, a sequence 
listing that is a ``Sequence Listing XML'' in accordance with Sec.  
1.831(a). The ``Sequence Listing XML'' must be accompanied by a 
statement that the information recorded does not go beyond the 
disclosure in the international application as filed. In response to 
such a requirement, the late furnishing fee set forth in Sec.  
1.445(a)(5) is also required. If the applicant fails to timely provide 
the required ``Sequence Listing XML,'' the United States International 
Searching Authority shall search only to the extent that a meaningful 
search can be performed without the ``Sequence Listing XML,'' and the 
United States International Preliminary Examining Authority shall 
examine only to the extent that a meaningful examination can be 
performed without the ``Sequence Listing XML.''
    (f) Any appropriate amendments to the ``Sequence Listing XML'' in a 
patent (e.g., by reason of reissue, reexamination, or certificate of 
correction) must comply with the requirements of paragraph (b) of this 
section.


Sec.  1.839  Incorporation by reference.

    (a) Certain material is incorporated by reference into this subpart 
with the approval of the Director of the Federal Register under 5 
U.S.C. 552(a) and 1 CFR part 51. All approved incorporation by 
reference (IBR) material is available for inspection at the USPTO and 
at the National Archives and Records Administration (NARA). Contact the 
USPTO's Office of Patent Legal Administration at 571-272-7701. For 
information on the availability of this material at NARA, email 
<a href="/cdn-cgi/l/email-protection#b0d6c29ed9dec3c0d5d3c4d9dfdef0ded1c2d19ed7dfc6"><span class="__cf_email__" data-cfemail="e28490cc8b8c91928781968b8d8ca28c839083cc858d94">[email protected]</span></a> or go to www.archives.gov/federal-register/cfr/ibr-locations.html. The material may be obtained from the source(s) in 
paragraph (b) of this section.
    (b) World Intellectual Property Organization (WIPO), 34 chemin des 
Colombettes, 1211 Geneva 20 Switzerland, www.wipo.int.
    (1) WIPO Standard ST.26. WIPO Handbook on Industrial 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 1.5, 
approved November 5, 2021; IBR approved for Sec. Sec.  1.831 through 
1.834.
    (2) [Reserved]

Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2022-10343 Filed 5-19-22; 8:45 am]
BILLING CODE 3510-16-P


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