Federal Register / Vol. 86, No. 126 / Tuesday, July 6, 2021 / Proposed Rules 35429 

withdrawn from warehouse for 

consumption, before [EFFECTIVE DATE 

OF FINAL RULE], these specific 

purposes are: country of origin marking; 

determining the rate of duty and staging 

category applicable to originating textile 

and apparel products as set out in 

Section 2 (Tariff Elimination) of Annex 

300–B (Textile and Apparel Goods) 

under NAFTA; and determining the rate 

of duty and staging category applicable 

to an originating good as set out in 

Annex 302.2 (Tariff Elimination) under 

NAFTA. CBP will determine the 

country of origin for all non-preferential 

purposes for goods imported into the 

United States from Canada or Mexico 

and entered for consumption, or 

withdrawn from warehouse for 

consumption, on or after [EFFECTIVE 

DATE OF FINAL RULE], using the rules 

set forth in §§ 102.1 through 102.18 and 

102.20. The rules in this part regarding 

goods wholly obtained or produced in a 

country are intended to apply 

consistently for all such purposes. The 

rules in this part which determine when 

a good becomes a new and different 

article or a new or different article of 

commerce as a result of manufacturing 

processes in a given country are also 

intended to apply consistently for all 

purposes where this requirement exists 

for ‘‘country of origin’’ or ‘‘product of’’ 

determinations made by CBP for goods 

imported from Canada or Mexico. The 

rules in this part do not affect similar 

determinations made by other agencies, 

such as the Department of Commerce’s 

scope determinations in antidumping or 

countervailing duty proceedings (see 19 

CFR 351.225). * * * 

PART 177—ADMINISTRATIVE 

RULINGS 

■ 3. The general authority citation for 

part 177 is revised to read as follows: 

Authority: 5 U.S.C. 301; 19 U.S.C. 66, 

1202 (General Note 3(i), Harmonized Tariff 

Schedule of the United States), 1502, 1624, 

1625, 2515. 

■ 4. Amend § 177.22 by adding a 

sentence to the end of paragraph (a) to 

read as follows: 

§ 177.22 Definitions. 

(a) * * * (For goods imported into the 

United States after processing in Canada 

or Mexico and entered for consumption, 

or withdrawn from warehouse for 

consumption, on or after [EFFECTIVE 

DATE OF FINAL RULE], substantial 

transformation will be determined using 

the rules set forth in §§ 102.1 through 

102.18 and 102.20.) 

* * * * * 

Troy A. Miller, the Senior Official 

Performing the Duties of the 

Commissioner, having reviewed and 

approved this document, is delegating 

the authority to electronically sign this 

document to Robert F. Altneu, who is 

the Director of the Regulations and 

Disclosure Law Division for CBP, for 

purposes of publication in the Federal 

Register. 

Robert F. Altneu, 

Director, Regulations & Disclosure Law 

Division, Regulations & Rulings, Office of 

Trade, U.S. Customs and Border Protection. 

Approved: 

Timothy E. Skud, 

Deputy Assistant Secretary of the Treasury. 

[FR Doc. 2021–14265 Filed 7–1–21; 11:15 am] 

BILLING CODE 9111–14–P 

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 XML (eXtensible 

Markup Language) in Patent 

Applications To Implement WIPO 

Standard ST.26; Incorporation by 

Reference 

AGENCY: United States Patent and 

Trademark Office, Department of 

Commerce. 

ACTION: Notice of proposed rulemaking. 

SUMMARY: The United States Patent and 

Trademark Office (USPTO or Office) is 

proposing to revise 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 the provisions of Standard 

ST.26 into the USPTO rules. Other 

conforming changes to accommodate for 

proposed new rules of practice based on 

the new standard are also included. 

These proposed amendments would 

apply to international and national 

applications filed on or after January 1, 

2022. In addition to simplifying the 

process for applicants filing in multiple 

countries, a requirement to submit a 

single sequence listing in eXtensible 

Mark-up Language (XML) format will 

result in better preservation, 

accessibility, and sorting of the 

submitted sequence data for the public. 

DATES: Comments must be received by 

September 7, 2021 to ensure 

consideration. 

ADDRESSES: For reasons of Government 

efficiency, comments must be submitted 

through the Federal eRulemaking Portal 

at www.regulations.gov. To submit 

comments via www.regulations.gov, 

enter docket number PTO–P–2021–0006 

on the homepage and click ‘‘Search.’’ 

The site will provide a search results 

page listing all documents associated 

with this docket. Find a reference to this 

notice and click on the ‘‘Comment 

Now!’’ icon, complete the required 

fields, and enter or attach your 

comments. Attachments to electronic 

comments will be accepted in ADOBE®

portable document format or 

MICROSOFT WORD® format. Because 

comments will be made available for 

public inspection, information that the 

submitter does not desire to make 

public, such as an address or phone 

number, should not be included in the 

comments. 

Visit the Federal eRulemaking Portal 

website (www.regulations.gov) for 

additional instructions on providing 

comments via the portal. If electronic 

submission of comments is not feasible 

due to lack of access to a computer and/ 

or the internet, please contact the 

USPTO using the contact information 

below for special instructions. 

FOR FURTHER INFORMATION CONTACT: 

Mary C. Till, Senior Legal Advisor, 

Office of Patent Legal Administration, 

Office of the Deputy Commissioner for 

Patents, by email at Mary.Till@

uspto.gov; or Ali Salimi, Senior Legal 

Advisor, Office of Patent Legal 

Administration, Office of the Deputy 

Commissioner for Patents, by email at 

Ali.Salimi@uspto.gov. Contact via 

telephone at 571–272–7704 for special 

instructions on submission of 

comments. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

a. Summary of Changes 

b. Introduction 

c. Standard ST.26 

d. Benefits 

e. WIPO Authoring and Validation Tool 

(WIPO Sequence) 

f. Applicability 

II. Discussion of Specific Rules 

III. Rulemaking Considerations 

I. Background 

a. Summary of Changes 

Standard ST.26 is the new 

international standard developed by the 

World Intellectual Property 

Organization (WIPO) and member states 

and adopted by the same. Under 

Standard ST.26, patent applications that 

contain disclosures of nucleotides and/ 

or amino acid sequence(s) must present 


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the associated biological sequence data 

in a standardized electronic format (a 

‘‘Sequence Listing XML’’) as a separate 

part of the specification. Under the 

proposed rules, in international 

applications filed under the Patent 

Cooperation Treaty (PCT) and in 

national and regional applications in 

Intellectual Property Offices (IPOs) of 

WIPO member states, an applicant will 

have to submit a single internationally 

acceptable sequence listing in a 

language neutral format using specified 

International Nucleotide Sequence 

Database Collaboration (INSDC) 

identifiers, such that a single sequence 

listing can be prepared for worldwide 

use. 

The proposed rule changes include: 

(1) Creation of new rules (§§ 1.831 

through 1.835) to incorporate by 

reference Standard ST.26; (2) use of 

INSDC sequence data elements to 

replace numeric identifiers from the 

previous standard; (3) modification of 

rules of practice to include reference to 

‘‘Sequence Listing XML;’’ (4) 

elimination of a paper or PDF copy of 

the sequence listing; (5) elimination of 

the option to include within a sequence 

listing sequences with fewer than 4 

amino acids and fewer than 10 

nucleotides; and (6) clarification and 

simplification of the rules to aid in 

understanding of the requirements that 

they set forth. 

b. Introduction 

The sequence rules (37 CFR 1.821 

through 1.825) provide a standardized 

format for description of nucleotide and 

amino acid sequence data in patent 

applications and require the submission 

of such sequences in computer readable 

form (CRF). The current USPTO rules 

are based on WIPO Standard ST.25, 

which became effective in 1998, and use 

a flat file structure of numeric 

identifiers using a limited set of 

character codes. A new international 

standard, ST.26, was agreed upon by 

WIPO member states, and would apply 

to international and national 

applications filed on or after January 1, 

2022. Applications pending prior to 

January 1, 2022, would not have to 

comply with Standard ST.26. 

In an effort to streamline and reduce 

the procedural requirements found in 

the existing rules, and to respond to the 

needs of our customers to conform to 

Standard ST.26, the USPTO is 

proposing to amend its rules of practice 

for submitting biological sequence data 

associated with disclosures of 

nucleotide and amino acid sequences in 

patent applications filed on or after 

January 1, 2022, to comply with 

Standard ST.26. 

To decrease the burden on applicants 

who file applications containing 

nucleotide and amino acid sequence 

information 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 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 (hereinafter 

referred to as a ‘‘Sequence Listing 

XML’’). In order to obtain public input 

on the content of Standard ST.26, the 

USPTO issued Requests for Comments 

in 2012 and 2016 (‘‘Request for 

Comments on the Recommendation for 

the Disclosure of Sequence Listings 

Using XML (Proposed ST.26).’’ (See 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).’’ (See 81 

FR 74775 (October 27, 2016))). The 

adopted version of Standard ST.26 takes 

those comments into account. To 

achieve the goals that WIPO and WIPO 

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 ST.26 for international and 

national applications filed on or after 

January 1, 2022. Therefore, upon 

finalizing the proposed rules, 

applications filed electronically in the 

United States on or after January 1, 

2022, would need to conform to 

Standard ST.26, which requires 

submitting sequence listings in XML 

format. The USPTO is further proposing 

that applications that claim benefit or 

priority to an earlier application, where 

the earlier application contained a 

sequence listing that complied with the 

Standard ST.25 sequence rules, comply 

with the new rules that incorporate by 

reference Standard ST.26. In order to 

facilitate compliance, WIPO Sequence, a 

sequence listing authoring and 

validating tool, has been developed by 

WIPO with input from WIPO member 

states so that applicants can use it to 

prepare and validate their sequence 

listings in XML format as discussed 

infra. The USPTO is proposing to add to 

the patent rules (37 CFR part 1) by 

incorporating by reference Standard 

ST.26, and providing conforming 

amendments to the current rules. 

To ensure that biological sequence 

data associated with the disclosures of 

nucleotides and/or amino acid 

sequence(s) 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) for 

inclusion of patent sequence data in the 

GenBank searchable database. For NCBI 

to include all sequence data from the 

USPTO, the data must be provided in 

INSDC format so that 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 provided 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 European Molecular Biology 

Laboratory, European Bioinformatics 

Institute (EMBL–EBI). WIPO has been 

working with the WIPO member states 

to create, adopt, and implement 

Standard ST.26 for sequence listing 

submissions in XML file format having 

the INSDC data elements to address the 

data loss. Standard ST.26 aims to 

enhance the accuracy and quality of 

biological sequence data that is publicly 

disseminated. In adopting and 

implementing Standard ST.26, more 

complete biological sequence data from 

patents and patent applications will be 

included in GenBank and thus be 

accessible by the public. The change 

from ASCII format to XML format will 

result in sequence data having computer 

tags that facilitate sorting and retrieving, 

and permit ease of access to the data. 

Additionally, NCBI is planning to stop 

accepting data in Standard ST.25 format 

for inclusion in GenBank in about 3–5 

years after January 1, 2022 (the Standard 

ST.26 transition date). 

c. Standard ST.26 

The WIPO ‘‘Handbook on Industrial 

Property Information and 

Documentation’’ sets forth standards for 

the presentation of data in many 

contexts. Standard ST.26 is titled 

‘‘Recommended Standard for the 

Presentation of Nucleotide and Amino 

Acid Sequence Listings Using XML 

(eXtensible Markup Language).’’ 

Adoption of the current version, version 

1.4, by the CWS, occurred in December 

of 2020 and reaffirms that January 1, 

2022, is expected to be the 

implementation date for all WIPO 

member states. The proposed USPTO 

rules incorporate by reference Standard 

ST.26. 


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The adopted version of Standard 

ST.26 is composed of eight documents, 

namely, the main body of the Standard, 

a first annex setting forth the controlled 

vocabulary for use with the main body, 

a second annex setting forth the 

Document Type Definition (DTD) for the 

Standard, a third annex containing a 

sequence listing specimen, a fourth 

annex setting forth the character subset 

from the Unicode Basic Latin Code 

Table, a fifth annex setting forth 

additional data exchange requirements 

for IPOs, a sixth annex containing a 

guidance document, and a seventh 

annex setting forth recommendations for 

the transformation of a sequence listing 

from Standard ST.25 format to Standard 

ST.26 format including avoiding adding 

or deleting subject matter. These 

materials can be found at http://

www.wipo.int/export/sites/www/ 

standards/en/pdf/03-26-01.pdf. The 

main body of Standard ST.26 defines 

the disclosures of nucleotide and amino 

acid sequences in patent applications 

that must be presented in a sequence 

listing in XML format in the manner 

specified in the Standard. Specifically, 

as detailed in paragraph eight of the 

main body, a sequence listing must not 

include, as a sequence assigned its own 

sequence identification number, any 

sequences having fewer than ten 

specifically defined nucleotides, or 

fewer than four specifically defined 

amino acids. The main body establishes 

the requirements for representation of 

nucleotide and amino acid sequences 

and the requirements for the XML file 

format for a sequence listing. The first 

annex 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, the first 

annex provides defined feature keys and 

qualifiers used for nucleotide and amino 

acid sequences in the XML file for a 

sequence listing. This first annex 

specifically identifies qualifiers with 

language-dependent ‘‘free text’’ values 

that may require translation for national 

and regional procedures. The second 

annex provides the DTD setting forth 

the technical specifications to which a 

submitted Sequence Listing XML must 

conform. The third annex provides a 

specimen of a Standard ST.26 compliant 

sequence listing 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 for a ‘‘Sequence Listing 

XML.’’ 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, is provided to 

ensure 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 comment in 2012 and 2016, 

mentioned above. The guidance 

document illustrates the requirements of 

selected paragraphs found in the main 

body of 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 within a Standard 

ST.26 compliant sequence listing in 

XML format. Annex VII addresses the 

potential consequence of these 

requirements when transforming a 

compliant Standard ST.25 sequence 

listing to a Standard ST.26 sequence 

listing, and provides detailed guidance 

on avoiding added or deleted subject 

matter due to the additional 

requirements of Standard ST.26. 

d. Benefits 

Transitioning from rules based on 

Standard ST.25 (i.e., the current basis 

for the USPTO rules for ‘‘Sequence 

Listings’’) to rules based on Standard 

ST.26 will be beneficial to both patent 

applicants filing sequence listings and 

IPOs receiving applications containing 

disclosures of nucleotide and amino 

acid sequences. Standard ST.26 

provides clear requirements as to 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 Standard ST.26 

contains a guidance document that 

illustrates the requirements for 

inclusion and representation of 

biological sequence data, patent 

applicants will have a clearer 

understanding of the requirements for 

presentation of biological sequence data 

in a compliant sequence listing under 

Standard ST.26. Additionally, since 

Standard ST.26 only allows XML 

format, the potential for differences 

under the current rules between a 

sequence listing filed in paper/PDF 

format and the required electronic CRF 

will be eliminated. As a further benefit, 

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 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 WIPO 

member states. Under Standard ST.25, 

IPOs have interpreted and enforced 

rules differently due to the imprecise 

language in the previous Standard. This 

has resulted in the frustrating situation 

where applicants generate sequence 

listings that may be accepted in one IPO 

but not another. 

Standard ST.26 was drafted to 

precisely define what must and must 

not be included in a sequence listing, 

and how sequences must be represented 

in a sequence listing. The ‘‘Guidance 

document with illustrated examples’’ in 

Annex VI of Standard ST.26 illustrates 

the application of the rules to real-world 

sequence disclosure examples, 

eliminating the possibility of 

misinterpretation by IPOs or applicants. 

Due to the improved data structure of 

XML, transitioning from the current 

USPTO rules based on Standard ST.25 

to rules based on Standard ST.26 will 

have the effect of increasing the quality 

of examination of patent applications 

containing biological sequence data 

since a more comprehensive search will 

be possible. Sequence listings submitted 

in accordance with 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 

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. Standard ST.26 

standardizes sequence variant 

presentation, annotation of modified 

and unusual residues, feature location 

descriptors, use of feature keys and 

qualifiers, organism names, and 

presentation of coding regions. 

Incorporation by reference of Standard 

ST.26 into USPTO rules has the effect 

of promoting data exchange between 

USPTO and NCBI due to 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 for biotechnology 

stakeholders that relate to nucleotide 

and amino acid sequences. 


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The USPTO recommends requiring 

compliance with Standard ST.26 for an 

application filed on or after January 1, 

2022, because it will reduce the 

complexity and cost of long-term 

maintenance of IT systems for accepting 

sequence listings in multiple formats, 

provide a clear implementation date, 

and will facilitate 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. 

As noted herein, WIPO has created a 

tool to assist applicants with translation 

of existing sequences to the new 

standard. 

e. WIPO Authoring and Validation Tool 

(WIPO Sequence) 

To comply with rules that are based 

on Standard ST.26, patent applicants 

will be able to use ‘‘WIPO Sequence,’’ 

a freely-available desktop application 

developed by WIPO and adopted by 

WIPO member states, to generate a 

Standard ST.26 compliant sequence 

listing. 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 

Standard ST.26. Such a sequence listing 

will be accepted by all IPOs of WIPO 

member states. Thus, the burden of 

generating a sequence listing which is 

acceptable across all WIPO member 

states will be significantly decreased for 

patent applicants under Standard ST.26. 

This tool will be downloadable, free of 

charge, from the WIPO website. 

Currently, a beta version of WIPO 

Sequence is accessible at https://

www.wipo.int/standards/en/sequence/ 

index.html. This beta version will allow 

the public to familiarize themselves 

with the tool and its dual 

functionalities. 

WIPO Sequence will allow a user to 

create and save 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 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 

Standard ST.26 projects, 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 dropdown lists, simplifying the creation of 

sequence listings. Applicant and 

inventor names, as well as custom 

organism names, can be stored within 

WIPO Sequence for ease of access. To 

facilitate review of data entered into a 

project, WIPO Sequence can generate a 

‘‘human-readable’’ version 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 

that are contained 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 Standard ST.26 format 

because certain data elements required 

for a Standard ST.26 compliant 

sequence listing 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 USPTO (in Annex VI 

and Annex VII of 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 in comment to 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. 

In order 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 ‘‘Sequence Listing XMLs’’ 

(§§ 1.831 through 1.835) and accepted 

since the WIPO Sequence Validator that 

USPTO will use is based on Standard 

ST.26, which is incorporated by 

reference into the USPTO proposed 

rules of practice. 

e. Applicability 

In accordance with these proposed 

rules of practice, an application that has 

a filing date on or after January 1, 2022, 

would be required to contain a sequence 

listing in accordance with proposed 

§§ 1.831 through 1.835, which 

incorporate by reference Standard 

ST.26. This includes applications that 

claim priority to applications with filing 

dates before January 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), section 120 (claiming the 

benefit as a continuation and/or 

continuation-in-part), section 121 

(claiming the benefit as a divisional), 

section 365 (claiming the benefit as a 

continuation or continuation in part to 

a PCT application), or section 119(a)–(d) 

(claiming the benefit 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, the 

applicant would be required to convert 

that sequence listing to Standard ST.26 

format for inclusion in the new 

application filed on or after January 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 filed under 35 U.S.C. 371, 

compliance with Standard ST.26 is 

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. The 

proposed rules would also be applicable 

to applications for reissue without 


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regard to the filing date of the originally 

granted patent for which reissue is 

sought. That is, any reissue application 

filed on or after January 1, 2022, where 

the disclosure or claims contain 

nucleotide and amino acid sequences 

would be required to comply with 

proposed §§ 1.831 through 1.835. 

Relying on the actual filing date of an 

application to determine whether a 

sequence listing must conform to 

§§ 1.821 through 1.825 (rules based on 

Standard ST.25) or §§ 1.831 through 

1.835 (rules based on Standard ST.26) 

will simplify the application of the 

sequence rules, both for the USPTO and 

the applicant. 

II. Discussion of Specific Rules 

Section 1.52: Paragraph (e)(1)(ii) was 

proposed to be amended in another 

rulemaking that published at 86 FR 

28301 (May 26, 2021). This proposed 

rule would further amend that 

paragraph to include reference to a 

‘‘Sequence Listing XML’’ submitted 

under § 1.831(a) in compliance with 

§§ 1.832 through 1.834. 

Section 1.52(e)(3)(iv) is proposed to 

be 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 

§ 1.834. 

Section 1.52(e)(7) was proposed to be 

amended in another rulemaking that 

published at 86 FR 28301 (May 26, 

2021). This proposed rule would further 

amend that paragraph to require that 

any amendment to the information on a 

read-only optical disc submitted in 

relation to a ‘‘Sequence Listing XML’’ be 

in accordance with § 1.835(b). 

Section 1.52(f)(1) was proposed to be 

amended in another rulemaking that 

published at 86 FR 28301 (May 26, 

2021). This proposed rule would further 

amend that paragraph to indicate 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 § 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 

‘‘any sequence listing.’’ 

Section 1.52(f)(1)(i) was proposed to 

be added in another rulemaking that 

published at 86 FR 28301 (May 26, 

2021). This proposed rule would further 

amend that paragraph to reference any 

‘‘Sequence Listing XML’’ in compliance 

with § 1.831(a). 

Section 1.52(f)(2) was proposed to be 

amended in another rulemaking that 

published at 86 FR 28301 (May 26, 

2021). This proposed rule would further 

amend that paragraph to indicate that 

any XML file, submitted via the USPTO 

patent electronic filing system for a 

‘‘Sequence Listing XML’’ in compliance 

with § 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 

electronic medium from the application 

size fee determination. A ‘‘Sequence 

Listing XML’’ is considered ‘‘any 

sequence listing.’’ 

Section 1.52(f)(2)(i) was proposed to 

be added in another rulemaking that 

published at 86 FR 28301 (May 26, 

2021). This proposed rule would further 

amend that paragraph to reference any 

‘‘Sequence Listing XML’’ in compliance 

with § 1.831(a). 

Section 1.52(f)(3) was proposed to be 

added in another rulemaking that 

published at 86 FR 28301 (May 26, 

2021). This proposed rule would further 

amend that paragraph to subject any 

‘‘Sequence Listing XML’’ of 300MB– 

800MB to the surcharge set forth in 

§ 1.21(o)(1) and any ‘‘Sequence Listing 

XML’’ over 800MB to the surcharge set 

forth in § 1.21(o)(2). 

Section 1.53: Section 1.53(c)(4) is 

proposed to be 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 

January 1, 2022, must be a ‘‘Sequence 

Listing XML’’ in compliance with 

§§ 1.831 through 1.834. This proposed 

change is not anticipated to cover 

applications filed before January 1, 

2022. 

Section 1.77: Section 1.77(b)(5) was 

proposed to be amended in another 

rulemaking that published at 86 FR 

28301 (May 26, 2021). This proposed 

rule would further amend that 

paragraph by reorganizing under 

§ 1.77(b)(5)(i) the provisions for an 

incorporation by reference statement for 

ASCII plain text tiles submitted for a 

‘‘Computer Program Listing Appendix’’ 

(§ 1.77(b)(5)(i)(A)), a ‘‘Sequence Listing’’ 

(§ 1.77(b)(5)(i)(B)), and ‘‘Large Tables’’ 

(§ 1.77(b)(5)(i)(C)). Section 1.77(b)(5)(ii) 

would contain provisions for an 

incorporation by reference statement for 

a ‘‘Sequence Listing XML’’ submitted 

via a USPTO patent electronic filing 

system or on one or more read-only 

optical discs. There would be no 

§ 1.77(b)(5)(iii). 

Section 1.121: Section 1.121(b) was 

proposed to be amended in another 

rulemaking that published at 86 FR 

28301 (May 26, 2021). This proposed 

rule would further amend that 

paragraph to add an exception to 

amendment practice for ‘‘Sequence 

Listing XML’’s (§ 1.835). 

Section 1.121(b)(6) was proposed to 

be added in another rulemaking that 

published at 86 FR 28301 (May 26, 

2021). This proposed rule would further 

amend that paragraph to require that 

changes to a ‘‘Sequence Listing XML’’ 

be made in accordance with § 1.835. 

Section 1.173: The heading of 

§ 1.173(b)(1) was proposed to be 

amended in another rulemaking that 

published at 86 FR 28301 (May 26, 

2021). This proposed rule would further 

amend that heading to include 

‘ ‘‘Sequence Listing XML’ (§ 1.831(a)).’’ 

Section 1.173(b)(1)(i) was proposed to 

be added in another rulemaking that 

published at 86 FR 28301 (May 26, 

2021). This proposed rule would further 

amend that paragraph to add an 

exception to reissue amendment 

practice for a ‘ ‘‘Sequence Listing XML’ 

(§ 1.831(a)).’’ 

Section 1.173(b)(1)(ii) was proposed 

to be added in another rulemaking that 

published at 86 FR 28301 (May 26, 

2021). This proposed rule would further 

amend that paragraph to provide that 

changes to a ‘‘Sequence Listing XML’’ 

must be made in accordance § 1.835. 

Section 1.173(d) was proposed to be 

amended in another rulemaking that 

published at 86 FR 28301 (May 26, 

2021). This proposed rule would further 

amend that paragraph to also exclude a 

‘‘Sequence Listing XML’’ from the 

manner of making amendments in a 

reissue application. 

Section 1.211: Section 1.211(c) is 

proposed to be amended to add a 

‘‘Sequence Listing’’ in compliance with 

§§ 1.821 through 1.825 (if applicable) for 

an application filed before January 1, 

2022, and a ‘‘Sequence Listing XML’’ in 

compliance with §§ 1.831 through 1.835 

(if applicable) for an application filed on 

or after January 1, 2022, to the currently 

listed items that may delay application 

publication if not present. 

Section 1.495: Section 1.495(c)(5) is 

proposed to be amended to delineate 

between translations needed for a 

‘‘Sequence Listing’’ in international 

applications entering the national stage 

in the United States having an 

international filing date before January 

1, 2022, and a ‘‘Sequence Listing’’ in 

XML format for international 

applications entering the national stage 

in the United States having an 

international filing date on or after 

January 1, 2022. Specifically, the 


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proposed amendment indicates that a 

‘‘Sequence Listing’’ need not be 

translated for national stage entry if the 

‘‘Sequence Listing’’ 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 January 1, 2022. 

However, the proposed amendment 

indicates that a ‘‘Sequence Listing’’ in 

XML format must be translated for 

national stage entry if a ‘‘Sequence 

Listing’’ in XML format was submitted 

in an international application with 

non-English language values for the 

invention title and/or any languagedependent free text qualifiers and has 

an international filing date on or after 

January 1, 2022. 

Section 1.530: The heading of 

§ 1.530(d)(1) was proposed to be 

amended in another rulemaking that 

published at 86 FR 28301 (May 26, 

2021). This proposed rule would further 

amend that heading to include 

‘ ‘‘Sequence Listing XML’ (§ 1.831(a)).’’ 

Section 1.530(d)(1)(i) was proposed to 

be added in another rulemaking that 

published at 86 FR 28301 (May 26, 

2021). This proposed rule would further 

amend that paragraph to add an 

exception to reexamination amendment 

practice for a ‘ ‘‘Sequence Listing XML’ 

(§ 1.831(a)).’’ 

Section 1.530(d)(1)(ii) was proposed 

to be added in another rulemaking that 

published at 86 FR 28301 (May 26, 

2021). This proposed rule would further 

amend that paragraph to provide that 

changes to a ‘‘Sequence Listing XML’’ 

must be made in accordance with 

§ 1.835. 

Section 1.704: Section 1.704(f) is 

proposed to be amended to add a 

‘‘Sequence Listing XML’’ in compliance 

with §§ 1.831 through 1.835 (if 

applicable) to the list of items that are 

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 proposes to add a 

‘‘Sequence Listing XML’’ in compliance 

with §§ 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 § 1.491(b). Lastly, the 

rule is also proposed to be amended to 

add a ‘‘Sequence Listing XML’’ in 

compliance with §§ 1.831 through 1.835 

(if applicable) to the current list of items 

for which an application is considered 

to be in compliance, 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 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. 

Section 1.831: Section 1.831 is 

proposed to be added to require that 

patent applications having disclosures 

of nucleotide and amino acid sequences, 

as those terms are defined in the rule, 

must contain, as a separate part of the 

disclosure, a ‘‘Sequence Listing XML’’ 

for patent applications having a filing 

date on or after January 1, 2022. 

Section 1.831(a) is proposed to be 

added to specify that the ‘‘Sequence 

Listing XML’’ uses the symbols and 

format in accordance with the 

requirements of §§ 1.832 through 1.834. 

Section 1.831(b)(1) and (2) are 

proposed to be added to define the 

nucleotide and amino acid sequences 

that are encompassed by the rule for 

which a ‘‘Sequence Listing XML’’ is 

needed. Specifically, nucleotide and/or 

amino acid sequences as used in these 

proposed rules encompass: An 

unbranched sequence or linear region of 

a branched sequence containing four 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 proposed to be 

added to state that, 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. 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 

specification or claims where it is clear 

that a sequence from the ‘‘Sequence 

Listing XML’’ is shown in the 

specification or claims. In identifying 

the sequence in the description or 

claims, the numeric sequence identifier 

from the ‘‘Sequence Listing XML’’ must 

be identifying the same sequence. 

Section 1.831(d) is proposed to be 

added to define the expression 

‘‘enumeration of its residues,’’ 

consistent with the definition in 

Paragraph 3(c) of WIPO Standard ST.26 

itself (which is incorporated by 

reference herein). 

Section 1.831(e) is proposed to be 

added to define the expression 

‘‘specifically defined,’’ consistent with 

the definition in Paragraph 3(m) of 

WIPO Standard ST.26 (2020). 

Section 1.831(f) is proposed to be 

added to define the expression ‘‘amino 

acid,’’ consistent with the definition in 

Paragraph 3(a) of WIPO Standard ST.26 

(2020). 

Section 1.831(g) is proposed to be 

added to define the expression 

‘‘modified amino acid,’’ consistent with 

the definition in Paragraph 3(g) of WIPO 

Standard ST.26 (2020). 

Section 1.831(h) is proposed to be 

added to define the expression 

‘‘nucleotide,’’ consistent with 

Paragraphs 3(h) and 3(i) of WIPO 

Standard ST.26 (2020). 

Section 1.831(i) is proposed to be 

added to define the expression 

‘‘modified nucleotide,’’ consistent with 

Paragraph 3(h) of WIPO Standard ST.26 

(2020). 

Section 1.832: Section 1.832 is 

proposed to be added to provide the 

manner in which a nucleotide and/or 

amino acid sequence is presented in the 

‘‘Sequence Listing XML’’ part of a 

patent application having a filing date 

on or after January 1, 2022. 

Section 1.832(a) is proposed to be 

added to define the requirements for 

representation of sequences in a 

‘‘Sequence Listing XML’’ part of the 

application. Specifically, each 

nucleotide and/or amino acid sequence 

presented in the ‘‘Sequence Listing 

XML’’ must be assigned a separate 

sequence identifier, and the sequence 

identifiers must begin with the number 

1, and increase sequentially by integers 

as defined in Paragraph 10 of WIPO 

Standard ST.26 (2020). 

Section 1.832(b)(1) through (4) are 

proposed to be added to define the 

requirements for 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 (2020). All nucleotides, including 

nucleotide analogs, modified 

nucleotides, ‘‘unknown’’ nucleotides in 

a nucleotide sequence must be 

represented and described using 

symbols in the manner described in 

Paragraphs 13–19 and 21 of WIPO 


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Standard ST.26 (2020). 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 (2020). 

Section 1.832(c)(1) through (4) are 

proposed to be added to define the 

requirements for 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 24–25 of WIPO Standard 

ST.26 (2020). All amino acids, including 

modified amino acids and ‘‘unknown’’ 

amino acids, in an amino acid sequence 

must be represented and described 

using symbols in the manner described 

in Paragraphs 24–30 and 32 of WIPO 

Standard ST.26 (2020). For a region 

containing a known number of 

contiguous ‘‘X’’ residues for which the 

same description applies, the entire 

region may be jointly described as 

provided in Paragraph 34 of WIPO 

Standard ST.26 (2020). 

Section 1.832(d) is proposed to be 

added to define the manner in which a 

single continuous sequence, derived 

from one or more non-contiguous 

segments of a larger sequence, or from 

segments of different sequences, must 

be represented, as described in 

Paragraph 35 of WIPO Standard ST.26 

(2020). 

Section 1.832(e) is proposed to be 

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, as described in Paragraph 

36 of WIPO Standard ST.26 (2020). 

Section 1.832(f) is proposed to be 

added to define the manner in which 

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, as described in Paragraph 

37 of WIPO Standard ST.26 (2020). 

Section 1.833: Section 1.833 is 

proposed to be added to describe the 

requirements for a ‘‘Sequence Listing 

XML,’’ which is required by § 1.831(a) 

for patent applications with a filing date 

on or after January 1, 2022, in order to 

comply with WIPO Standard ST.26 

(2020). 

Section 1.833(a) is proposed to be 

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(b)(1) is proposed to be 

added to require that the ‘‘Sequence 

Listing XML’’ must be valid according 

to the DTD as presented in Annex II of 

WIPO Standard ST.26 (2020). 

Section 1.833(b)(2) is proposed to be 

added to require that a ‘‘Sequence 

Listing XML’’ must comply with the list 

of items enumerated in (i)–(v) which are 

found in WIPO Standard ST.26 (2020). 

Section 1.833(b)(2)(i) is proposed to 

be added to require that the ‘‘Sequence 

Listing XML’’ contain an XML 

declaration as defined in WIPO 

Standard ST.26 (2020), Paragraph 39. 

Section 1.833(b)(2)(ii) is proposed to 

be added to require that the ‘‘Sequence 

Listing XML’’ contain a document type 

declaration as defined in WIPO 

Standard ST.26 (2020), Paragraph 39. 

Section 1.833(b)(2)(iii) is proposed to 

be added to require that the ‘‘Sequence 

Listing XML’’ contain a root element as 

defined in WIPO Standard ST.26 (2020), 

Paragraph 43. 

Section 1.833(b)(2)(iv) is proposed to 

be added to require that the ‘‘Sequence 

Listing XML’’ contain a general 

information part that complies with 

WIPO Standard ST.26 (2020), 

Paragraphs 45, 47 and 48, as applicable. 

Section 1.833(b)(2)(v) is proposed to 

be added to require that the ‘‘Sequence 

Listing XML’’ contain a sequence data 

part that complies with WIPO Standard 

ST.26 (2020), Paragraphs 50–55, 57–58, 

60–69, 71–78, 80–87, 89–98 and 100, as 

applicable. 

Section 1.833(b)(3) is proposed to be 

added to require that the ‘‘Sequence 

Listing XML’’ contains at least one 

InventionTitle element, as set forth in 

WIPO Standard ST.26 at Paragraphs 45 

and 48, in the English language since 

English is required under § 1.52(b)(1)(ii). 

Section 1.833(b)(4) is proposed to be 

added to require that an INSDQualifier_

value element includes a value for that 

element in the English language for each 

language-dependent free text qualifier in 

the ‘‘Sequence Listing XML,’’ as 

required by § 1.52(b)(1)(ii), and where 

an INSDQualifier_value element is 

defined in WIPO Standard ST.26 (2020), 

Paragraphs 76 and 85–88. 

Section 1.834: Section 1.834 is 

proposed to be 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 January 1, 2022. 

Section 1.834(a) is proposed to be 

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 §§ 1.831 through 1.833 

must: (1) Have the following 

compatibilities: (i) Computer 

compatibility: PC or Mac®; and (ii) 

operating system compatibility (e.g., 

MS–DOS®, MS-Windows®, Mac OS®, or 

Unix®/Linux®); (2) be in XML format, 

where all permitted printable characters 

(including the space character) and nonprintable (control) characters are 

defined in Paragraph 40 of WIPO 

Standard ST.26 (2020); 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 proposed to be 

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 § 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®, 7- 

Zip, or Unix®/Linux® Zip, (iii) a 

compressed file must not be selfextracting, and (iv) a compressed XML 

file that does not fit on a single readonly optical disc may be split into 

multiple file parts in accordance with 

the target read-only optical disc size and 

labeled in compliance with 

§ 1.52(e)(5)(vi). 

Section 1.835: Section 1.835 is 

proposed to be added to provide the 

requirements for submission of an 

amendment to add or replace a 

‘‘Sequence Listing XML’’ for 

applications filed on or after January 1, 

2022. 

Section 1.835(a) is proposed to be 

added to require that any amendment to 

a patent application adding an initial 

submission of a ‘‘Sequence Listing 

XML’’ as required by § 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 § 1.52(e); (2) an instruction 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 § 1.77(b)(5)(ii)), 

except when submitted to the United 

States International Preliminary 

Examining Authority for an 


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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 proposed to be 

added to require that any amendment 

adding to, deleting from or replacing 

sequence information in a ‘‘Sequence 

Listing XML’’ submitted as required by 

§ 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 readonly optical disc, in compliance with 

§ 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 § 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 proposed to be 

added to require that the specification of 

a complete application with a 

‘‘Sequence Listing XML’’ as required 

under § 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 

§ 1.77(b)(5)(ii), except for international 

applications. 

Section 1.835(d)(1) is proposed to be 

added to provide that when any of the 

requirements of §§ 1.831 through 1.834 

is 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. The proposed rule indicates 

that subject to § 1.835(d)(2), any 

amendment to add or replace a 

‘‘Sequence Listing XML’’ in reply to a 

requirement under this paragraph must 

be submitted in accordance with the 

requirements of § 1.835(a) through (c). 

Section 1.835(d)(2) is proposed to be 

added to explicitly provide that 

compliance with § 1.835(a) through (c) 

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 the 

invention title (as per § 1.833(b)(3)) and/ 

or any language-dependent free text 

elements (as per § 1.833(b)(4)). The 

required submission will be a translated 

‘‘Sequence Listing XML’’ in compliance 

with §§ 1.831 through 1.834. Updated 

values for attributes in the root element 

(§ 1.833(b)(2)(iii)) or elements of the 

general information part 

(§ 1.833(b)(2)(iv)) are not considered 

amendments for purposes of complying 

with § 1.835(a) through (c). Even though 

§§ 1.52(b)(1)(ii) and 1.495(c)(1)(i) 

require a translation for applications 

filed under 111(a) and for those entering 

the national stage, respectively, this 

proposed rule makes explicit that when 

a translated ‘‘Sequence Listing XML’’ is 

provided as a reply to a notice that the 

‘‘Sequence Listing XML’’ contains nonEnglish values for the invention title 

and/or any language-dependent free text 

elements, and the translation does not 

include deletions, additions 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 § 1.835(a) through 

(c). 

Section 1.835(e) is proposed to be 

added to provide that when any of the 

requirements of §§ 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, applicant can provide, in reply to 

such a requirement or otherwise, a 

sequence listing which is a ‘‘Sequence 

Listing XML’’ in accordance with 

§ 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. It 

must also be accompanied by the late 

furnishing fee set forth in § 1.445(a)(5). 

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 proposed to be 

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 

proposed to be added to provide the 

location of WIPO Standard ST.26 (2020) 

that is being incorporated by reference. 

III. Rulemaking Considerations 

A. Administrative Procedure Act: The 

changes proposed in this rulemaking 

involve rules of agency practice and 

procedure, and/or interpretive rules. See 

Bachow Commc’ns Inc. v. FCC, 237 F.3d 

683, 690 (D.C. Cir. 2001) (rules 

governing an application process are 

procedural under the Administrative 

Procedure Act); Inova Alexandria Hosp. 

v. Shalala, 244 F.3d 342, 350 (4th Cir. 

2001) (rules for handling appeals are 

procedural where they do not change 

the substantive standard for reviewing 

claims); Nat’l Org. of Veterans’ 

Advocates v. Sec’y of Veterans Affairs, 

260 F.3d 1365, 1375 (Fed. Cir. 2001) 

(rule that clarifies interpretation of a 

statute is interpretive). 

Accordingly, prior notice and 

opportunity for public comment for the 

changes proposed in this rulemaking are 

not required pursuant to 5 U.S.C. 553(b) 

or (c), or any other law. See Cooper 

Techs. Co. v. Dudas, 536 F.3d 1330, 

1336–37 (Fed. Cir. 2008) (stating that 5 

U.S.C. 553, and thus 35 U.S.C. 

2(b)(2)(B), do not require notice and 

comment rulemaking for ‘‘interpretative 

rules, general statements of policy, or 

rules of agency organization, procedure, 

or practice’’ (quoting 5 U.S.C. 

553(b)(A))). However, the USPTO has 

chosen to seek public comment before 


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implementing the rule to benefit from 

the public’s input. 

B. Regulatory Flexibility Act: Under 

the Regulatory Flexibility Act (5 U.S.C. 

601 et seq.), whenever an agency is 

required by 5 U.S.C. 553 (or any other 

law) to publish a notice of proposed 

rulemaking (NPRM), the agency must 

prepare and make available for public 

comment an Initial Regulatory 

Flexibility Analysis, unless the agency 

certifies under 5 U.S.C. 605(b) that the 

proposed rule, if implemented, will not 

have a significant economic impact on 

a substantial number of small entities. 5 

U.S.C. 603, 605. 

For the reasons set forth herein, 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 proposes to amend the 

rules of practice to require submission 

of biological sequence data in 

eXtensible Markup Language 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)’’ as 

disclosed in the WIPO Handbook on 

Industrial Property Information and 

Documentation. 

This rulemaking would make more 

technical data associated with 

biotechnology inventions available to 

the public because the new rules of 

practice based on WIPO Standard ST.26 

(2020) provide for enhanced biological 

sequence data related to disclosures of 

nucleotides and amino acids 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, for 

example, standardization of 

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 

or confused with 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. This 

rulemaking’s proposed changes are 

largely procedural in nature, and do not 

impose any additional requirements or 

fees on applicants. For the foregoing 

reasons, the changes proposed in this 

NPRM 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 

litigation, eliminate ambiguity, and 

reduce burden as set forth in sections 

3(a) and 3(b)(2) of Executive Order 

12988 (Feb. 5, 1996). 

I. Executive Order 13045 (Protection 

of Children): This rulemaking does not 

concern an environmental risk to health 

or safety that may disproportionately 

affect children under Executive Order 

13045 (Apr. 21, 1997). 

J. Executive Order 12630 (Taking of 

Private Property): This rulemaking will 

not effect a taking of private property or 

otherwise have taking implications 

under Executive Order 12630 (Mar. 15, 

1988). 

K. Congressional Review Act: Under 

the Congressional Review Act 

provisions of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (5 U.S.C. 801 et seq.), prior to 

issuing any final rule, 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 


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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 proposed 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 proposed rulemaking will be 

submitted to OMB for approval prior to 

this rule becoming effective. 

Modifications include the removal of 

the Sequence Listing in Application 

(paper), which will result in a reduction 

in burden associated with this 

information collection. The USPTO 

estimates that this information 

collection’s annual burden will decrease 

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 proposed rule. 

The changes discussed in this 

proposed 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 

proposes to further amend 37 CFR part 

1 (as proposed to be amended at 86 FR 

28301 (May 26, 2021)) as follows: 

PART 1—RULES OF PRACTICE IN 

PATENT CASES 

■ 1. The authority citation for 37 CFR 

part 1 continues to read as follows: 

Authority: 35 U.S.C. 2(b)(2), unless 

otherwise noted. 

■ 2. Section 1.52 is amended by: 

■ a. Revising paragraph (e)(1)(ii); 

■ b. Removing the period at the end of 

paragraph (e)(3)(iii) and adding ‘‘; and’’ 

in its place; 

■ c. Adding paragraph (e)(3)(iv); and 

■ d. 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: 

§ 1.52 Language, paper, writing, margins, 

read-only optical disc specifications. 

* * * * * 

(e) * * * 

(1) * * * 

(ii) A ‘‘Sequence Listing’’ (submitted 

under § 1.821(c) in compliance with 

§ 1.824) or a ‘‘Sequence Listing XML’’ 

(submitted under § 1.831(a) in 

compliance with §§ 1.832 through 

1.834); or 

* * * * * 

(3) * * * 

(iv) 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 § 1.834. 

* * * * * 

(7) Any amendment to the 

information on a read-only optical disc 

must be by way of a replacement readonly optical disc, in compliance with 

§ 1.58(g) for ‘‘Large Tables,’’ § 1.96(c)(5) 

for a ‘‘Computer Program Listing 

Appendix,’’ § 1.825(b) for a ‘‘Sequence 

Listing’’ or Computer Readable Form 

(CRF) of a ‘‘Sequence Listing,’’ and 

§ 1.835(b) for a ‘‘Sequence Listing 

XML.’’ 

* * * * * 

(f) * * * 

(1) Submission on read-only optical 

discs. The application size fee required 

by § 1.16(s) or § 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 § 1.821(c) or (e), or any ‘‘Sequence 

Listing XML’’ in compliance with 

§ 1.831(a); or 

* * * * * 

(2) Submission via the USPTO patent 

electronic filing system. The application 

size fee required by § 1.16(s) or 

§ 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 of 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 § 1.821(c) or (e) or any ‘‘Sequence 

Listing XML’’ in compliance with 

§ 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 

§ 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 § 1.21(o)(2). 

■ 3. Section 1.53 is amended by revising 

paragraph (c)(4) to read as follows: 

§ 1.53 Application number, filing date, and 

completion of application. 

* * * * * 


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(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 § 1.55, or 

to the benefit of an earlier filing date 

under 35 U.S.C. 120, 121, 365(c), or 

386(c) or § 1.78 of any other application. 

No claim for priority under 35 U.S.C. 

119(e) or § 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 January 1, 

2022, any submission of biological 

sequence data must be a ‘‘Sequence 

Listing XML’’ in compliance with 

§§ 1.831 through 1.834. 

* * * * * 

■ 4. Section 1.77 is amended by revising 

paragraph (b)(5) to read as follows: 

§ 1.77 Arrangement of application 

elements. 

* * * * * 

(b) * * * 

(5) An incorporation by reference 

statement regarding the material on the: 

(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 

§ 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 § 1.96(c)); 

(B) A ‘‘Sequence Listing’’ (see 

§ 1.821(c)); or 

(C) ‘‘Large Tables’’ (see § 1.58(c)). 

(ii) eXtensible Markup Language 

(XML) file of the Sequence Listing 

(‘‘Sequence Listing XML’’), submitted 

via an USPTO patent electronic filing 

system or on one or more read-only 

optical discs (see § 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 (§ 1.831(a)). 

* * * * * 

■ 5. Section 1.121 is amended by 

revising paragraphs (b) introductory text 

and (b)(6) read as follows: 

§ 1.121 Manner of making amendments in 

applications. 

* * * * * 

(b) Specification. Amendments to the 

specification, other than the claims, 

‘‘Large Tables’’ (§ 1.58(c)), a ‘‘Computer 

Program Listing Appendix’’ (§ 1.96(c)(5) 

and (7)), a ‘‘Sequence Listing’’ or CRF 

(§ 1.825), or ‘‘Sequence Listing XML’’s 

(§ 1.835), must be made by adding, 

deleting, or replacing a paragraph, by 

replacing a section, or by a substitute 

specification, in the manner specified in 

this section. 

* * * * * 

(6) ‘‘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 § 1.58(g) for ‘‘Large 

Tables,’’ § 1.96(c)(5) for a ‘‘Computer 

Program Listing Appendix,’’ § 1.825 for 

a ‘‘Sequence Listing,’’ and § 1.835 for a 

‘‘Sequence Listing XML.’’ 

* * * * * 

■ 6. Section 1.173 is amended by 

revising paragraphs (b)(1) and (d) 

introductory text to read as follows: 

§ 1.173 Reissue specification, drawings, 

and amendments. 

* * * * * 

(b) * * * 

(1) Specification other than the 

claims, ‘‘Large Tables’’ (§ 1.58(c)), a 

‘‘Computer Program Listing Appendix’’ 

(§ 1.96(c)), a ‘‘Sequence Listing’’ 

(§ 1.821(c)) or a ‘‘Sequence Listing XML’’ 

(§ 1.831(a)). (i) Changes to the 

specification, other than to the claims, 

‘‘Large Tables’’ (§ 1.58(c)), a ‘‘Computer 

Program Listing Appendix’’ (§ 1.96(c)), a 

‘‘Sequence Listing’’ (§ 1.821(c)) or a 

‘‘Sequence Listing XML’’ (§ 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 § 1.58(g) for ‘‘Large 

Tables,’’ § 1.96(c)(5) for a ‘‘Computer 

Program Listing Appendix,’’ § 1.825 for 

a ‘‘Sequence Listing,’’ and § 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,’’ a ‘‘Computer 

Program Listing Appendix,’’ a 

‘‘Sequence Listing,’’ or a ‘‘Sequence 

Listing XML’’, upon filing or by an 

amendment paper in the reissue 

application, must include the following 

markings: 

* * * * * 

■ 7. Section 1.211 is amended by 

revising paragraph (c) to read as follows; 

§ 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 (§ 1.16(a) 

or (c)) and any English translation 

required by § 1.52(d). The Office may 

delay publishing any application until it 

includes any application size fee 

required by the Office under § 1.16(s) or 

§ 1.492(j), a specification having papers 

in compliance with § 1.52 and an 

abstract (§ 1.72(b)), drawings in 

compliance with § 1.84, a ‘‘Sequence 

Listing’’ in compliance with §§ 1.821 

through 1.825 (if applicable) for an 

application filed before January 1, 2022, 

a ‘‘Sequence Listing XML’’ in 

compliance with §§ 1.831 through 1.835 

(if applicable) for an application filed on 

or after January 1, 2022, and the 

inventor’s oath or declaration or 

application data sheet containing the 

information specified in § 1.63(b). 

* * * * * 

■ 8. Section 1.495 is amended by 

revising paragraph (c)(5) to read as 

follows: 

§ 1.495 Entering the national stage in the 

United States of America. 

* * * * * 

(c) * * * 

(5) Translations of a ‘‘Sequence 

Listing:’’ For international applications 

having an international filing date 

before January 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 

January 1, 2022, for purposes of 

paragraph (c)(1)(i) of this section, an 

English translation is required for any 

‘‘Sequence Listing’’ in XML format 

containing non-English language values 

for the invention title/and or any 

language-dependent free text qualifiers 

in accordance with §§ 1.831 through 

1.834. 

* * * * * 

■ 9. Section 1.530 is amended by 

revising paragraph (d)(1) to read as 

follows: 

§ 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’’ (§ 1.58(c)), a 


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‘‘Computer Program Listing Appendix’’ 

(§ 1.96(c)), a ‘‘Sequence Listing’’ 

(§ 1.821(c)) or a ‘‘Sequence Listing XML 

(§ 1.831(a)). (i) Changes to the 

specification, other than to the claims, 

‘‘Large Tables’’ (§ 1.58(c)), a ‘‘Computer 

Program Listing Appendix’’ (§ 1.96(c)), a 

‘‘Sequence Listing’’ (§ 1.821(c)), or a 

‘‘Sequence Listing XML’’ (§ 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 § 1.58(g) for ‘‘Large 

Tables,’’ § 1.96(c)(5) for a ‘‘Computer 

Program Listing Appendix,’’ § 1.825 for 

a ‘‘Sequence Listing,’’ and § 1.835 for a 

‘‘Sequence Listing XML.’’ 

* * * * * 

■ 10. Section 1.704 is amended by 

revising paragraph (f) to read as follows: 

§ 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 the application 

includes a specification, including at 

least one claim and an abstract 

(§ 1.72(b)), and has papers in 

compliance with § 1.52, drawings (if 

any) in compliance with § 1.84, any 

English translation required by § 1.52(d) 

or § 1.57(a), a sequence listing in 

compliance with §§ 1.821 through 1.825 

(if applicable), a ‘‘Sequence Listing 

XML’’ in compliance with §§ 1.831 

through 1.835 (if applicable), an 

inventor’s oath or declaration or an 

application data sheet containing the 

information specified in § 1.63(b), the 

basic filing fee (§ 1.16(a) or (c)), the 

search fee (§ 1.16(k) or (m)), the 

examination fee (§ 1.16(o) or (q)), any 

certified copy of the previously filed 

application required by § 1.57(a), and 

any application size fee required by the 

Office under § 1.16(s). An international 

application is in condition for 

examination when the application has 

entered the national stage as defined in 

§ 1.491(b), and includes a specification, 

including at least one claim and an 

abstract (§ 1.72(b)), and has papers in 

compliance with § 1.52, drawings (if 

any) in compliance with § 1.84, a 

sequence listing in compliance with 

§§ 1.821 through 1.825 (if applicable), a 

‘‘Sequence Listing XML’’ in compliance 

with §§ 1.831 through 1.835 (if 

applicable), the inventor’s oath or 

declaration or an application data sheet 

containing the information specified in 

§ 1.63(b), the search fee (§ 1.492(b)), the 

examination fee (§ 1.492(c)), and any 

application size fee required by the 

Office under § 1.492(j). An application 

shall be considered as having papers in 

compliance with § 1.52, drawings (if 

any) in compliance with § 1.84, and a 

sequence listing in compliance with 

§§ 1.821 through 1.825 (if applicable) or 

a ‘‘Sequence Listing XML’’ in 

compliance with §§ 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, or sequence listing 

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. 

■ 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 January 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 January 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 January 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 January 1, 

2022. 

1.835 Amendment to add or replace a 

‘‘Sequence Listing XML’’ in patent 

applications filed on or after January 1, 

2022. 

1.839 Incorporation by reference. 

* * * * * 

§ 1.831 Requirements for patent 

applications filed on or after January 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 (eXtensible 

Markup Language) format (a ‘‘Sequence 

Listing XML’’). Disclosed nucleotide or 

amino acid sequences that do not meet 

the definition of paragraph (b) of this 

section must not be included in the 

‘‘Sequence Listing XML.’’ The 

‘‘Sequence Listing XML’’ contains the 

sequence information of the nucleotides 

and/or amino acids disclosed in the 

patent application using the symbols 

and format in accordance with the 

requirements of §§ 1.832 through 1.834. 

(b) Nucleotide and/or amino acid 

sequences as used in §§ 1.831 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. 

(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 WIPO Standard ST.26 

(2020) (incorporated by reference, see 

§ 1.839), paragraph 3(c)(i) or (ii). 

(e) ‘‘Specifically defined’’ means any 

amino acid or nucleotide as defined in 

WIPO Standard ST.26 (2020), paragraph 

3(m). 

(f) ‘‘Amino acid’’ includes any D- or 

L-amino acid or modified amino acid as 

defined in WIPO Standard ST.26 (2020), 

paragraph 3(a). 

(g) ‘‘Modified amino acid’’ includes 

any amino acid as described in WIPO 

Standard ST.26 (2020), paragraph 3(g). 

(h) ‘‘Nucleotide’’ includes any 

nucleotide, nucleotide analog or 

modified nucleotide as defined in WIPO 

Standard ST.26 (2020), paragraphs 3(h) 

and 3(i). 

(i) ‘‘Modified nucleotide’’ includes 

any nucleotide as described in WIPO 

Standard ST.26 (2020), paragraph 3(h). 


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§ 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 January 1, 2022. 

(a) Each disclosed nucleotide or 

amino acid sequence that meets the 

requirements of § 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 WIPO Standard 

ST.26 (2020) (incorporated by reference, 

see § 1.839), paragraph 10. 

(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 

WIPO Standard ST.26 (2020), 

paragraphs 11–12. 

(2) All nucleotides, including 

nucleotide analogs, modified 

nucleotides, and ‘‘unknown’’ 

nucleotides, within a nucleotide 

sequence must be represented using the 

symbols set forth in WIPO Standard 

ST.26 (2020), paragraphs 13–16, 19 and 

21. 

(3) Modified nucleotides within a 

nucleotide sequence must be described 

in the manner discussed in WIPO 

Standard ST.26 (2020), paragraphs 17– 

18, and 19. 

(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 

WIPO Standard ST.26 (2020), paragraph 

22. 

(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 WIPO Standard 

ST.26 (2020), paragraphs 24–25. 

(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 WIPO Standard 

ST.26 (2020), paragraphs 26–29 and 32. 

(3) Modified amino acid within an 

amino acid sequence must be described 

in the manner discussed in WIPO 

Standard ST.26 (2020), paragraphs 29 

and 30. 

(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 WIPO Standard ST.26 

(2020), paragraph 34. 

(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 from segments of 

different sequences must be listed in a 

sequence listing in the manner 

described in WIPO Standard ST.26 

(2020), paragraph 35. 

(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 a 

sequence listing in the manner 

described in WIPO Standard ST.26 

(2020), paragraph 36. 

(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 a sequence listing in the 

manner described in WIPO Standard 

ST.26 (2020), paragraph 37. 

§ 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 January 1, 2022. 

(a) The ‘‘Sequence Listing XML’’ as 

required by § 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 WIPO 

Standard ST.26 (2020) (incorporated by 

reference, see § 1.839), paragraphs 40 

and 41 and Annex IV thereof. 

(b) The ‘‘Sequence Listing XML’’ as 

required by § 1.833(a) must: 

(1) Be valid according to the 

Document Type Definition (DTD) as 

presented in Annex II of WIPO Standard 

ST.26 (2020). 

(2) Comply with the requirements of 

WIPO Standard ST.26 (2020) to include: 

(i) An XML declaration as defined in 

WIPO Standard ST.26 (2020), paragraph 

39; 

(ii) A document type (DOCTYPE) 

declaration as defined in WIPO 

Standard ST.26 (2020), paragraph 39; 

(iii) A root element as defined in 

WIPO Standard ST.26 (2020), paragraph 

43; 

(iv) A general information part that 

complies with the requirements of 

WIPO Standard ST.26 (2020), 

paragraphs 45, 47 and 48, as applicable; 

and 

(v) A sequence data part that complies 

with the requirements of WIPO 

Standard ST.26 (2020), paragraphs 50– 

55, 57–58, 60–69, 71–78, 80–87, 89–98 

and 100, as applicable. 

(3) Include one InventionTitle 

element in the English language, in the 

format required by WIPO Standard 

ST.26 (2020), paragraphs 45 and 48, and 

as required by § 1.52(b)(1)(ii). 

(4) Include an INSDQualifier_value 

element with a value in the English 

language for any language-dependent 

free text qualifier as defined by WIPO 

Standard ST.26 (2020), paragraphs 76 

and 85–88, and as required by 

§ 1.52(b)(1)(ii). 

§ 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 January 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 §§ 1.831 through 1.833, 

must: 

(1) Have the following compatibilities: 

(i) Computer compatibility: PC or 

Mac®; and 

(ii) Operating system compatibility: 

MS–DOS®, MS-Windows®, Mac OS®, or 

Unix®/Linux®. 

(2) Be in XML format, where all 

permitted printable characters 

(including the space character) and nonprintable (control) characters are 

defined in WIPO Standard ST.26 (2020) 

(incorporated by reference, see § 1.839), 

paragraph 40. 

(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 § 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®, 7-Zip, or Unix®/Linux® 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 


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optical disc size, and labeled in 

compliance with § 1.52(e)(5)(vi). 

§ 1.835 Amendment to add or replace a 

‘‘Sequence Listing XML’’ in patent 

applications filed on or after January 1, 

2022. 

(a) Any amendment to a patent 

application adding an initial submission 

of a ‘‘Sequence Listing XML’’ as 

required by § 1.831(a) after the 

application filing date must include: 

(1) A ‘‘Sequence Listing XML’’ in 

accordance with §§ 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 § 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 § 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 

§ 1.831(a) must include: 

(1) A replacement ‘‘Sequence Listing 

XML’’ in accordance with the 

requirements of §§ 1.831 through 1.834 

containing the entire ‘‘Sequence Listing 

XML’’ including any additions, 

deletions, or replacements of sequence 

information, and shall be submitted: 

(i) Via the USPTO patent electronic 

filing system; or 

(ii) On a read-only optical disc, in 

compliance with § 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 § 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 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 § 1.831(a), 

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 

§ 1.77(b)(5)(ii), except for international 

applications. 

(d)(1) If any of the requirements of 

§§ 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’’ in reply to a 

requirement under this paragraph (d)(1) 

must be submitted in accordance with 

the requirements of paragraphs (a) 

through (c) of this section. 

(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 the invention 

title (as per § 1.833(b)(3)) and/or any 

language-dependent free text elements 

(as per § 1.833(b)(4)). The required 

submission will be a translated 

‘‘Sequence Listing XML’’ in compliance 

with §§ 1.831 through 1.834. Updated 

values for attributes in the root element 

(§ 1.833(b)(2)(iii)) or elements of the 

general information part 

(§ 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 

§§ 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 applicant can provide, 

in reply to such a requirement or 

otherwise, a sequence listing which is a 

‘‘Sequence Listing XML’’ in accordance 

with § 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. It 

must also be accompanied by the late 

furnishing fee set forth in § 1.445(a)(5). 

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. 

§ 1.839 Incorporation by reference. 

(a) Certain material is incorporated by 

reference into this subpart with the 

approval of the approval of the Director 

of the Federal Register under 5 U.S.C. 

552(a) and 1 CFR part 51. All approved 

material is available for inspection at 

The United States Patent and Trademark 

Office, Office of Patent Legal 

Administration, 571–272–7701, and 

from the sources listed elsewhere in this 

section. It is also available for 

inspection at the National Archives and 

Records Administration (NARA). For 

information on the availability of this 

material at NARA, email fedreg.legal@

nara.gov or go to www.archives.gov/ 

federal-register/cfr/ibr-locations.html. 

(b) World Intellectual Property 

Organization (WIPO); 34 chemin des 

Colombettes; 1211 Geneva 20 

Switzerland, www.wipo.int. 

(1) WIPO Standard ST.26 (2020). 

WIPO Handbook on Industrial Property 

Information and Documentation, 

Standard ST.26: Recommended 


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Standard for the Presentation of 

Nucleotide and Amino Acid Sequence 

Listings Using XML (eXtensible Markup 

Language) (2020), including Annexes I– 

VII (www.wipo.int/export/sites/www/ 

standards/en/pdf/03-26-01.pdf); IBR 

approved for §§ 1.831 through 1.834. 

(2) [Reserved] 

Andrew Hirshfeld, 

Commissioner for Patents, Performing the 

Functions and Duties of the Under Secretary 

of Commerce for Intellectual Property and 

Director of the United States Patent and 

Trademark Office. 

[FR Doc. 2021–14325 Filed 7–2–21; 8:45 am] 

BILLING CODE 3510–16–P 

DEPARTMENT OF TRANSPORTATION 

Federal Motor Carrier Safety 

Administration 

49 CFR Part 385 

[Docket No. FMCSA–2021–0063] 

RIN 2126–AC40 

Incorporation by Reference; North 

American Standard Out-of-Service 

Criteria; Hazardous Materials Safety 

Permits 

AGENCY: Federal Motor Carrier Safety 

Administration (FMCSA), Department 

of Transportation (DOT). 

ACTION: Notice of proposed rulemaking. 

SUMMARY: FMCSA proposes 

amendments to its Hazardous Materials 

Safety Permits regulations to 

incorporate by reference the updated 

Commercial Vehicle Safety Alliance 

(CVSA) handbook containing inspection 

procedures and Out-of-Service Criteria 

(OOSC) for inspections of shipments of 

transuranic waste and highway route 

controlled quantities of radioactive 

material. The OOSC provide 

enforcement personnel nationwide, 

including FMCSA’s State partners, with 

uniform enforcement tolerances for 

inspections. Currently, the regulations 

reference the April 1, 2019, edition of 

the handbook. Through this document, 

FMCSA proposes to incorporate by 

reference the April 1, 2021 edition. 

DATES: Comments on this document 

must be received on or before August 5, 

2021. 

ADDRESSES: You may submit comments 

identified by Docket Number FMCSA 

2021–0063 using any of the following 

methods: 

• Federal eRulemaking Portal: 

https://www.regulations.gov/docket/ 

FMCSA-2021-0063/document. Follow 

the online instructions for submitting 

comments. 

• Mail: Dockets Operations, U.S. 

Department of Transportation, 1200 

New Jersey Avenue SE, West Building, 

Ground Floor, Room W12–140, 

Washington, DC 20590–0001. 

• Hand Delivery or Courier: West 

Building, Ground Floor, Room W12– 

140, 1200 New Jersey Avenue SE, 

Washington, DC, between 9 a.m. and 5 

p.m., Monday through Friday, except 

Federal holidays. To be sure someone is 

there to help you, please call (202) 366– 

9317 or (202) 366–9826 before visiting 

Dockets Operations. 

• Fax: (202) 493–2251. 

To avoid duplication, please use only 

one of these four methods. See the 

‘‘Public Participation and Request for 

Comments’’ portion of the 

SUPPLEMENTARY INFORMATION section for 

instructions on submitting comments. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Jose ́ Cestero, Vehicle and Roadside 

Operations Division, Federal Motor 

Carrier Safety Administration, 1200 

New Jersey Avenue SE, Washington, DC 

20590–0001, (202) 366–5541, 

jose.cestero@dot.gov. If you have 

questions on viewing or submitting 

material to the docket, contact Dockets 

Operations, (202) 366–9826. 

SUPPLEMENTARY INFORMATION: This 

notice of proposed rulemaking (NPRM) 

is organized as follows: 

I. Public Participation and Request for 

Comments 

A. Submitting Comments 

B. Viewing Comments and Documents 

C. Privacy Act 

D. Advance Notice of Proposed 

Rulemaking Not Required 

II. Executive Summary 

III. Legal Basis for the Rulemaking 

IV. Background 

V. Discussion of Proposed Rulemaking 

VI. International Impacts 

VII. Section-by-Section Analysis 

VIII. Regulatory Analyses 

A. E.O. 12866 (Regulatory Planning and 

Review), E.O. 13563 (Improving 

Regulation and Regulatory Review), and 

DOT Regulations 

B. Congressional Review Act 

C. Regulatory Flexibility Act (Small 

Entities) 

D. Assistance for Small Entities 

E. Unfunded Mandates Reform Act of 1995 

F. Paperwork Reduction Act 

G. E.O. 13132 (Federalism) 

H. Privacy 

I. E.O. 13175 (Indian Tribal Governments) 

J. National Environmental Policy Act of 

1969 

I. Public Participation and Request for 

Comments 

A. Submitting Comments 

If you submit a comment, please 

include the docket number for this 

NPRM (Docket No. FMCSA–2021– 

0063), indicate the specific section of 

this document to which your comment 

applies, and provide a reason for each 

suggestion or recommendation. You 

may submit your comments and 

material online or by fax, mail, or hand 

delivery, but please use only one of 

these means. FMCSA recommends that 

you include your name and a mailing 

address, an email address, or a phone 

number in the body of your document 

so that FMCSA can contact you if there 

are questions regarding your 

submission. 

To submit your comment online, go to 

https://www.regulations.gov/docket/ 

FMCSA-2021-0063/document, click on 

this NPRM, click ‘‘Comment,’’ and type 

your comment into the text box on the 

following screen. 

If you submit your comments by mail 

or hand delivery, submit them in an 

unbound format, no larger than 81⁄2 by 

11 inches, suitable for copying and 

electronic filing. If you submit 

comments by mail and would like to 

know that they reached the facility, 

please enclose a stamped, self-addressed 

postcard or envelope. 

FMCSA will consider all comments 

and material received during the 

comment period. 

Confidential Business Information 

Confidential Business Information 

(CBI) is commercial or financial 

information that is both customarily and 

actually treated as private by its owner. 

Under the Freedom of Information Act 

(FOIA) (5 U.S.C. 552), CBI is exempt 

from public disclosure. If your 

comments responsive to this NPRM 

contain commercial or financial 

information that is customarily treated 

as private, that you actually treat as 

private, and that is relevant or 

responsive to this NPRM, it is important 

that you clearly designate the submitted 

comments as CBI. Please mark each 

page of your submission that constitutes 

CBI as ‘‘PROPIN’’ to indicate it contains 

proprietary information. FMCSA will 

treat such marked submissions as 

confidential under the FOIA, and they 

will not be placed in the public docket 

of this NPRM. Submissions containing 

CBI should be sent to Mr. Brian Dahlin, 

Chief, Regulatory Analysis Division, 

Federal Motor Carrier Safety 

Administration, 1200 New Jersey 

Avenue SE, Washington DC 20590– 

0001. Any comments FMCSA receives 

which are not specifically designated as 

CBI will be placed in the public docket 

for this rulemaking. 

B. Viewing Comments and Documents 

To view documents mentioned in this 

preamble as being available in the 


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