30806 Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Rules and Regulations 

Federal agencies to assess the effects of 

their discretionary regulatory actions. In 

particular, the Act addresses actions 

that may result in the expenditure by a 

State, local, or tribal government, in the 

aggregate, or by the private sector of 

$100,000,000 (adjusted for inflation) or 

more in any one year. Though this rule 

will not result in such an expenditure, 

we do discuss the effects of this rule 

elsewhere in this preamble. 

F. Environment 

We have analyzed this rule under 

Department of Homeland Security 

Directive 023–01, Rev. 1, associated 

implementing instructions, and 

Environmental Planning COMDTINST 

5090.1 (series), which guide the Coast 

Guard in complying with the National 

Environmental Policy Act of 1969 (42 

U.S.C. 4321–4370f), and have 

determined that this action is one of a 

category of actions that do not 

individually or cumulatively have a 

significant effect on the human 

environment. This rule involves a safety 

zone lasting 7 hours that would prohibit 

entry within an approximate 1.2 miles 

of the Columbia River for the duration 

of a high-speed hydroplane testing 

event. It is categorically excluded from 

further review under L60(a) of 

Appendix A, Table 1 of DHS Instruction 

Manual 023–01–001–01, Rev. 1. A 

Record of Environmental Consideration 

supporting this determination is 

available in the docket. For instructions 

on locating the docket, see the 

ADDRESSES section of this preamble. 

G. Protest Activities 

The Coast Guard respects the First 

Amendment rights of protesters. 

Protesters are asked to call or email the 

person listed in the FOR FURTHER

INFORMATION CONTACT section to 

coordinate protest activities so that your 

message can be received without 

jeopardizing the safety or security of 

people, places or vessels. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine Safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard amends 33 

CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 46 U.S.C. 70034, 70051; 33 CFR 

1.05–1, 6.04–1, 6.04–6, and 160.5; 

Department of Homeland Security Delegation 

No. 00170.1, Revision No. 01.2. 

■ 2. Add § 165.T13–0140 to read as 

follows: 

§ 165.T13–0140 Safety Zone; Columbia 

River, Vancouver, WA 

(a) Location. The following area is a 

safety zone: All navigable waters of the 

Columbia River, from surface to bottom, 

starting approximately 700 yards east of 

the I–5 bridge from shoreline to 

shoreline heading east for 

approximately 1.2 miles; specifically 

beginning at the shoreline at 45°36′40.7′′ 

N, 122°40′11.2′′ W, northeast to 

45°37′08.7′′ N, 122°39′53.8′′ W, 

southeast to 45°36′41.3′′ N, 122°38′32.0′′ 

W, thence southwest to 45°36′15.8′′ N, 

122°38′53.0′′ W, and along the shoreline 

back to the beginning point. 

(b) Definitions. As used in this 

section: 

Designated representative means a 

Coast Guard Patrol Commander, 

including a Coast Guard coxswain, petty 

officer, or other officer operating a Coast 

Guard vessel and a Federal, State, and 

local officer designated by or assisting 

the COTP in the enforcement of the 

regulations in this section. 

Participant means all persons and 

vessels registered with the event 

sponsor as a participant in the testing 

event. 

(c) Regulations. (1) Under the general 

safety zone regulations in subpart C of 

this part, you may not enter the safety 

zone described in paragraph (a) of this 

section unless authorized by the COTP 

or the COTP’s designated representative. 

(2) To seek permission to enter, 

contact the COTP or the COTP’s 

representative by calling (503) 209–2468 

or the Sector Columbia River Command 

Center on Channel 16 VHF–FM. Those 

in the safety zone must comply with all 

lawful orders or directions given to 

them by the COTP or the COTP’s 

designated representative. 

(d) Enforcement period. This section 

will be enforced from 8:30 a.m. until 

3:30 p.m. on May 20, 2022. It will be 

subject to enforcement this entire period 

unless the COTP determines it is no 

longer needed, in which case the Coast 

Guard will inform mariners via Notice 

to Mariners. 

Dated: May 13, 2022. 

G.M. Bailey, 

Captain, U.S. Coast Guard, Alternate Captain 

of the Port Sector Columbia River. 

[FR Doc. 2022–10835 Filed 5–19–22; 8:45 am] 

BILLING CODE 9110–04–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 eXtensible Markup 

Language (XML) in Patent Applications 

To Implement WIPO Standard ST.26; 

Incorporation by Reference 

AGENCY: United States Patent and 

Trademark Office, Department of 

Commerce. 

ACTION: Final rule. 

SUMMARY: The United States Patent and 

Trademark Office (USPTO or Office) is 

amending the rules of practice for 

submitting biological sequence data 

associated with disclosures of 

nucleotide and amino acid sequences in 

patent applications by incorporating by 

reference certain provisions of World 

Intellectual Property Office Standard 

ST.26 (WIPO Standard ST.26) into the 

USPTO rules of practice. Other 

conforming changes to accommodate 

the new rules of practice based on the 

new standard are also included. In 

addition to simplifying the process for 

applicants filing in multiple countries, 

the requirement to submit a single 

sequence listing in eXtensible Markup 

Language (XML) format, or ‘‘Sequence 

Listing XML,’’ will result in better 

preservation, accessibility, and sorting 

of the submitted sequence data for the 

public. 

DATES: Effective date: This final rule is 

effective on July 1, 2022. The 

incorporation by reference of certain 

publications listed in this rule is 

approved by the Director of the Federal 

Register as of July 1, 2022. 

Applicability date: Patent 

applications filed on or after July 1, 

2022, having disclosures of nucleotide 

and/or amino acid sequences as defined 

in 37 CFR 1.831(b) must comply with 

new rules for submission of a 

‘‘Sequence Listing XML’’ in accordance 

with 37 CFR 1.831 through 1.835. All 

other provisions of this final rule apply 

to all patent applications filed before, 

on, or after July 1, 2022. 

FOR FURTHER INFORMATION CONTACT: 

Mary C. Till, Senior Legal Advisor, 

Office of Patent Legal Administration, 

Office of the Deputy Commissioner for 

Patents, at Mary.Till@uspto.gov or 571– 

272–7755; or Ali Salimi, Senior Legal 

Advisor, Office of Patent Legal 

Administration, Office of the Deputy 


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Commissioner for Patents, at 

Ali.Salimi@uspto.gov or 571–272–0909. 

SUPPLEMENTARY INFORMATION: 

Table of Contents 

I. Background 

a. Summary of Changes 

b. Introduction 

c. Incorporation by Reference of WIPO 

Standard ST.26 

d. Benefits 

e. WIPO Authoring and Validation Tool 

(WIPO Sequence) 

f. Applicability 

II. Discussion of Specific Rules 

III. Comments and Responses 

IV. Rulemaking Considerations 

I. Background 

a. Summary of Changes 

WIPO Standard ST.26 is the new 

international standard developed and 

adopted by WIPO and member states for 

purposes of presenting biotechnology 

information in patent applications. It 

will apply to international and national 

applications filed on or after July 1, 

2022. New provisions in 37 CFR 1.831 

through 1.835 implement WIPO 

Standard ST.26. Applications pending 

prior to July 1, 2022, will not have to 

comply with WIPO Standard ST.26; 

rather, such applications will require 

the submission of a ‘‘Sequence Listing,’’ 

as defined in 37 CFR 1.821(a), in 

compliance with 37 CFR 1.8211.825. 

Under WIPO Standard ST.26 (as 

implemented by 37 CFR 1.831 through 

1.835), patent applications that contain 

disclosures of nucleotide and/or amino 

acid sequences must present the 

associated biological sequence data in a 

standardized electronic format (a 

‘‘Sequence Listing XML’’) as a separate 

part of the specification. In particular, 

WIPO Standard ST.26 permits 

applicants to submit a single, 

internationally acceptable sequence 

listing in a language-neutral format 

using specified International Nucleotide 

Sequence Database Collaboration 

(INSDC) identifiers in international 

applications filed under the Patent 

Cooperation Treaty (PCT) and in 

national and regional applications in the 

intellectual property offices (IPOs) of 

WIPO member states. As a result, a 

single sequence listing in compliance 

with WIPO Standard ST.26 can be 

prepared for use in the IPOs of WIPO 

member states. 

For applications filed on or after July 

1, 2022, the changes in this final rule 

include the: (1) Creation of new rules 

(37 CFR 1.831 through 1.839) that 

incorporate by reference WIPO Standard 

ST.26; (2) use of INSDC sequence data 

elements to replace numeric identifiers 

used in the previous Standard ST.25 for 

the submission of nucleotide and/or 

amino acid sequences; (3) modification 

of rules of practice to include reference 

to a ‘‘Sequence Listing XML’’; (4) 

elimination of the ability to file a paper 

or Portable Document Format (PDF) 

copy of nucleotide and/or amino acid 

sequences; (5) elimination of the option 

to include within a ‘‘Sequence Listing 

XML,’’ sequences with fewer than 4 

specifically defined amino acids and 

fewer than 10 specifically defined 

nucleotides; and (6) clarification and 

simplification of the rules to aid in 

understanding the requirements set 

forth. 

b. Introduction 

In an effort to streamline and reduce 

existing procedural requirements and to 

implement WIPO Standard ST.26, the 

USPTO is amending its rules of practice 

(by adding 37 CFR 1.831 through 1.839) 

for submitting biological sequence data 

associated with disclosures of 

nucleotide and/or amino acid sequences 

in patent applications filed on or after 

July 1, 2022. These changes also 

respond to the needs of our customers 

to comply with WIPO Standard ST.26. 

To decrease the burden on applicants 

who file patent applications containing 

nucleotide and/or amino acid sequences 

internationally, the USPTO has worked 

with other WIPO member states as part 

of the Committee on WIPO Standards 

(CWS) to develop a single, 

internationally acceptable sequence 

listing standard for use in patent 

applications filed in those member 

states. Beginning in October of 2010, the 

CWS established a task force to propose 

a revised standard for the filing of 

nucleotide and/or amino acid sequence 

listings in XML file format. To obtain 

public input on the content of WIPO 

Standard ST.26, the USPTO issued 

requests for comments in 2012 and 

2016. See Request for Comments on the 

Recommendation for the Disclosure of 

Sequence Listings Using XML (Proposed 

ST.26), 77 FR 28541 (May 15, 2012); and 

Standard ST.26—Request for Comments 

on the Recommended Standard for the 

Presentation of Nucleotide and Amino 

Acid Sequence Listings Using XML 

(eXtensible Markup Language), 81 FR 

74775 (October 27, 2016). The adopted 

version of WIPO Standard ST.26 takes 

those comments into account. To 

achieve the goals WIPO and its member 

states (including the United States) set 

out by developing the sequence listing 

standard for presenting data 

consistently across all IPOs, all WIPO 

member states agreed to implement 

WIPO Standard ST.26 for international 

and national applications filed on or 

after July 1, 2022. Therefore, in view of 

this final rule, applications filed in the 

United States on or after July 1, 2022, 

will need to conform to WIPO Standard 

ST.26 as implemented in 37 CFR 1.831 

through 1.839, which requires 

submitting sequence listings in XML 

format. 

Under the final rule, applications that 

claim benefit or priority to an earlier 

application, where the earlier 

application contained a sequence listing 

that complied with the requirements of 

Standard ST.25 or other earlier 

requirements, must comply with the 

new rules that incorporate by reference 

WIPO Standard ST.26. To facilitate 

compliance, WIPO, with input from 

WIPO member states, developed WIPO 

Sequence, a sequence listing authoring 

and validating tool that applicants can 

use to prepare and validate their 

sequence listings in XML format, as 

discussed below. The USPTO is adding 

to the patent rules (37 CFR part 1) by 

incorporating by reference WIPO 

Standard ST.26, and providing 

conforming amendments to the current 

rules. 

To ensure that biological sequence 

data associated with the disclosures of 

nucleotide and/or amino acid sequences 

in patent applications can be widely 

disseminated and searchable by the 

public and IPOs, the USPTO works with 

the National Center for Biotechnology 

Information (NCBI) on the inclusion of 

patent sequence data in the GenBank 

searchable database. For the NCBI to 

include all sequence data from the 

USPTO, the data must be provided in 

INSDC format so it is compatible with 

GenBank. The Standard ST.25 format 

sequence listings cannot be readily 

converted to INSDC format, resulting in 

only a fraction of patent sequence 

information appearing in GenBank. This 

data loss limits the sequence 

information available to the public and 

exchanged with other sequence database 

providers (e.g., the National Institute of 

Genetics (NIG) in Japan, the DNA Data 

Bank of Japan (DDBJ), and the European 

Molecular Biology Laboratory, European 

Bioinformatics Institute (EMBL–EBI). 

WIPO has been working with the WIPO 

member states to create, adopt, and 

implement WIPO Standard ST.26 for 

sequence listing submissions in XML 

file format, which has the INSDC data 

elements to address the data loss. WIPO 

Standard ST.26 aims to enhance the 

accuracy and quality of biological 

sequence data that is publicly 

disseminated. With the adoption and 

implementation of WIPO Standard 

ST.26, more complete biological 

sequence data from patents and patent 

applications will be included in 

GenBank and thus be accessible by the 


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public. The change from American 

Standard Code for Information 

Interchange (ASCII) plain text format to 

XML format will result in sequence data 

having computer tags that facilitate 

sorting and retrieving and will permit 

ease of access to the data. Additionally, 

the NCBI plans to stop accepting data in 

Standard ST.25 format for inclusion in 

GenBank approximately three to five 

years after the WIPO Standard ST.26 

transition date (July 1, 2022). 

c. Incorporation by Reference of WIPO 

Standard ST.26 

The WIPO ‘‘Handbook on Industrial 

Property Information and 

Documentation’’ sets forth standards for 

the presentation of data in many 

contexts. WIPO Standard ST.26 is titled 

‘‘RECOMMENDED STANDARD FOR 

THE PRESENTATION OF 

NUCLEOTIDE AND AMINO ACID 

SEQUENCE LISTINGS USING XML 

(EXTENSIBLE MARKUP LANGUAGE).’’ 

The CWS adopted the current version 

(version 1.5) in November of 2021. In 

October of 2021, at the Assemblies of 

Member States of WIPO, the member 

states agreed on July 1, 2022, as the 

implementation date of WIPO Standard 

ST.26. This final rule incorporates by 

reference WIPO Standard ST.26. The 

standard is available from WIPO, 34 

chemin des Colombettes, 1211 Geneva 

20 Switzerland, www.wipo.int. and also 

as provided for in 37 CFR 1.839. 

WIPO Standard ST.26 is composed of 

eight documents, namely, the main 

body of the standard, a first annex 

(Annex I) setting forth the controlled 

vocabulary for use with the main body, 

a second annex (Annex II) setting forth 

the Document Type Definition (DTD) for 

the Sequence Listing, a third annex 

(Annex III) containing a sequence listing 

specimen (XML file), a fourth annex 

(Annex IV) setting forth the character 

subset from the Unicode Basic Latin 

Code Table, a fifth annex (Annex V) 

setting forth additional data exchange 

requirements for IPOs, a sixth annex 

(Annex VI) containing a guidance 

document with illustrated examples, 

and a seventh annex (Annex VII) setting 

forth recommendations for the 

transformation of a sequence listing 

from Standard ST.25 format to WIPO 

Standard ST.26 format, including 

guidance on how to avoid adding or 

deleting subject matter. 

The main body of WIPO Standard 

ST.26 defines the disclosures of 

nucleotide and/or amino acid sequences 

in patent applications that must be 

presented in a sequence listing in XML 

format in the manner specified in the 

standard. As detailed in paragraph eight 

of the main body, a sequence listing in 

XML format must not include any 

sequences having fewer than 10 

specifically defined nucleotides, or 

fewer than 4 specifically defined amino 

acids. If such sequences are included in 

the disclosure, they must not be 

assigned a sequence identification 

number. The main body establishes the 

requirements for the representation of 

nucleotide and/or amino acid sequences 

and the requirements for the XML file 

format for a sequence listing. Annex I 

contains controlled vocabulary that 

provides nucleotide base codes, lists of 

modified nucleotides and their 

abbreviations, amino acid codes, and a 

list of modified amino acids and their 

abbreviations. In addition, Annex I 

provides defined feature keys and 

qualifiers used for nucleotide and/or 

amino acid sequences in the XML file 

for a sequence listing. Annex I 

specifically identifies qualifiers with 

language-dependent ‘‘free text’’ values 

that may require translation for national 

and regional procedures. Annex II 

provides the DTD setting forth the 

technical specifications to which a 

submitted Sequence Listing XML must 

conform. Annex III provides a link to a 

specimen of a sequence listing that is 

compliant with WIPO Standard ST.26 

and that shows a representation of an 

entire sequence listing in XML format. 

Annex IV provides a table of the 

character subset from the Unicode Basic 

Latin Code that will be used in the XML 

file for the sequence listing. Annex V 

provides guidance to WIPO member 

states on how certain sequence elements 

should be populated when data is 

exchanged with database providers. 

Annex VI, containing the guidance 

document, ensures that all applicants 

and WIPO member states understand 

the requirements for inclusion and 

representation of sequence disclosures. 

This guidance document was 

developed, in part, to address concerns 

raised in response to the USPTO’s 

requests for comments in 2012 and 

2016, mentioned above. The guidance 

document illustrates the requirements of 

selected paragraphs in the main body of 

WIPO Standard ST.26 through specific 

examples of nucleotide and amino acid 

biological sequence data. Additionally, 

the document provides guidance on the 

manner in which biological sequence 

data is represented in a sequence listing 

in XML format that is compliant with 

WIPO Standard ST.26. Annex VII 

addresses the mandatory requirements 

of WIPO Standard ST.26, and the 

potential consequence of these 

requirements when transforming a 

compliant Standard ST.25 sequence 

listing into a WIPO Standard ST.26 

sequence listing. Annex VII also 

provides detailed guidance on how to 

avoid adding or deleting subject matter 

due to the additional requirements of 

WIPO Standard ST.26. 

d. Benefits 

Transitioning from rules based on 

WIPO Standard ST.25 (i.e., the basis for 

USPTO rules 37 CFR 1.821 through 

1.825, regarding ‘‘Sequence Listings’’) to 

rules based on WIPO Standard ST.26 

will be beneficial to both patent 

applicants filing sequence listings and 

IPOs receiving applications containing 

disclosures of nucleotide and/or amino 

acid sequences requiring sequence 

listings. WIPO Standard ST.26 provides 

clear requirements for what must be 

included in a sequence listing and how 

sequences must be represented. For 

example, it standardizes the 

representation of modified nucleotide 

sequences and amino acid sequences as 

well as variants derived from primary 

sequences. Since WIPO Standard ST.26 

contains a guidance document that 

illustrates the requirements for the 

inclusion and representation of 

biological sequence data, patent 

applicants will have a better 

understanding of the requirements for 

the presentation of biological sequence 

data in a compliant sequence listing 

under WIPO Standard ST.26 (as 

implemented by 37 CFR 1.831 through 

1.839). Additionally, since WIPO 

Standard ST.26 only allows XML format 

(an electronic computer readable 

format), this final rule eliminates the 

potential for differences between a 

sequence listing filed in paper/PDF 

format and the required electronic 

computer readable format (CRF). As a 

further benefit, the IPOs of WIPO 

member states will no longer need to 

expend resources to process paper 

sequence listings and perform necessary 

checks on the contents of paper 

documents. 

Unlike rules based on Standard ST.25, 

rules based on WIPO Standard ST.26 

will allow patent applicants to file a 

single sequence listing with the USPTO 

(with the exception of changes to 

comply with national language 

requirements) that will be acceptable to 

the IPOs of all WIPO member states. 

Under Standard ST.25, IPOs have 

interpreted and enforced rules 

differently due to the imprecise 

language in that standard. This has 

resulted in the frustrating situation in 

which applicants generate sequence 

listings that may be accepted in one IPO 

but not another. 

WIPO Standard ST.26 was drafted to 

precisely define what must and must 

not be included in a sequence listing 


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and how sequences must be represented 

in a sequence listing. The ‘‘Guidance 

document with illustrated examples’’ in 

Annex VI of WIPO Standard ST.26 

demonstrates the application of the 

rules to real-world sequence disclosure 

examples, reducing the possibility of 

misinterpretation by IPOs or applicants. 

Due to the improved data structure of 

XML, transitioning to rules based on 

WIPO Standard ST.26 will increase the 

quality of the examination of patent 

applications containing biological 

sequence data since a more 

comprehensive search will be possible. 

Sequence listings submitted in 

accordance with WIPO Standard ST.26 

allow for targeted searching of both 

sequence annotation and newly 

required sequence types, such as Damino acids, nucleotide analogues, and 

linear portions of branched sequences. 

Finally, sequence listing submissions 

under rules based on WIPO Standard 

ST.26 will enhance public database 

content, as they include the sequence 

annotations (e.g., feature keys and 

qualifiers) used by database providers to 

describe biological sequence data. WIPO 

Standard ST.26 standardizes sequence 

variant presentation, the annotation of 

modified and unusual residues, feature 

location descriptors, the use of feature 

keys and qualifiers, organism names, 

and the presentation of coding regions. 

Incorporation by reference of WIPO 

Standard ST.26 into USPTO rules 

promotes data exchange between the 

USPTO and the NCBI due to the use of 

INSDC identifiers required by database 

providers. The presence of additional 

data, as well as the enhanced 

compatibility to facilitate the exchange 

of data, will increase the value of 

database searches that relate to 

nucleotide and amino acid sequences 

for biotechnology stakeholders. 

Requiring compliance with WIPO 

Standard ST.26 for an application filed 

on or after July 1, 2022, will reduce the 

complexity and cost of the long-term 

maintenance of information technology 

(IT) systems for accepting sequence 

listings in multiple formats, provide a 

clear implementation date, and facilitate 

the transition to the format requirements 

of database providers. In addition, a 

requirement to submit a single sequence 

listing in XML format will result in 

better preservation, accessibility, and 

sorting of the submitted sequence data 

for the public. 

e. WIPO Authoring and Validation Tool 

(WIPO Sequence) 

To comply with rules based on WIPO 

Standard ST.26, patent applicants will 

be able to generate a sequence listing 

compliant with WIPO Standard ST.26 

using WIPO Sequence, a desktop 

application developed by WIPO and 

adopted by WIPO member states. WIPO 

Sequence has two functions: An 

authoring function and a validation 

function. Patent applicants will be able 

to author and validate their sequence 

listing using WIPO Sequence to comply 

with the requirements of WIPO 

Standard ST.26. Such a sequence listing 

will be accepted by all the IPOs of the 

WIPO member states. Thus, the burden 

of generating a sequence listing that is 

acceptable across all WIPO member 

states will be significantly decreased for 

patent applicants under WIPO Standard 

ST.26. This tool is downloadable, free of 

charge, from the WIPO website. The 

current version of WIPO Sequence is 

accessible at www.wipo.int/standards/ 

en/sequence/index.html. This version, 

subject to updates, will allow the public 

to become familiar with the tool and its 

dual functionalities. 

WIPO Sequence will allow a user to 

create and save (author) patent 

application data and biological 

sequence data in a project, validate the 

project to ensure all required 

information is present, and generate a 

sequence listing in WIPO Standard 

ST.26 XML format. Information can be 

entered into a project manually, or data 

can be imported from a source file in 

one of a number of file types. WIPO 

Sequence can import data from other 

WIPO Standard ST.26 projects, WIPO 

Standard ST.26 XML sequence listings, 

Standard ST.25 sequence listing text 

files, raw files, multi-sequence format 

files, and FASTA (FAST-All-a DNA and 

protein sequence alignment software 

package) files. Feature keys, qualifiers, 

and organism names are available to 

select from drop-down lists, simplifying 

the creation of sequence listings. 

Applicant and inventor names, as well 

as custom organism names, can be 

stored in WIPO Sequence for easy 

access. To facilitate the review of data 

entered into a project, WIPO Sequence 

can generate a ‘‘human-readable’’ 

version (a text version of the sequence 

data) of the sequence listing in addition 

to the XML sequence listing. 

WIPO Sequence includes an 

integrated validation function that will 

alert users to most errors in a project or 

sequence listing data. The validation 

function generates a report that clearly 

lists every detected error, the location of 

the error, and the detected value of the 

error, along with a link to the sequence 

in question, thereby ensuring users can 

correct errors before generating a final 

sequence listing. While the validation 

function will alert a user to most errors 

in a project or sequence listing, there are 

a small number of errors that can be 

detected only by human review (for 

example, an inappropriate organism 

name). In those cases, the integrated 

validation function will list a ‘‘warning’’ 

in the validation report, reminding users 

of the applicable/relevant rule and 

urging them to check their input values 

before generating a final sequence 

listing. 

A sequence listing in Standard ST.25 

format cannot automatically be 

converted into WIPO Standard ST.26 

format because certain data elements 

required for a sequence listing 

compliant with WIPO Standard ST.26 

are not present in Standard ST.25. 

Therefore, conversion of a sequence 

listing in Standard ST.25 format to 

Standard ST.26 format necessarily 

requires additional input from the 

applicant. WIPO Sequence, 

supplemented by significant guidance 

from WIPO and the USPTO (in Annex 

VI and Annex VII of WIPO Standard 

ST.26), will help applicants accomplish 

this task. Users can import a Standard 

ST.25 sequence listing into a project, 

and WIPO Sequence automatically 

performs many of the necessary 

conversions. An Import Report is 

generated that alerts the user to all data 

conversions and lists all sequence 

entries that require additional input. In 

response to concerns raised regarding 

the USPTO’s requests for comments in 

2012 and 2016, the USPTO, in 

conjunction with WIPO, developed 

Annex VII to provide detailed guidance 

to help applicants avoid added or 

deleted subject matter when converting 

a sequence listing from Standard ST.25 

format into Standard ST.26 format. 

To ensure that IPOs can validate and 

accept sequence listing projects from 

applicants generated with WIPO 

Sequence, WIPO is developing a 

Standard ST.26 sequence listing 

validation tool, WIPO Sequence 

Validator. WIPO Sequence Validator 

will be for use by IPOs. WIPO Sequence 

Validator will be synchronized with the 

validation function in the WIPO 

Sequence tool. The USPTO is 

integrating WIPO Sequence Validator 

into its internal IT systems. The WIPO 

Sequence Validator will apply the same 

validation rules as WIPO Sequence. 

Therefore, filers will have a greater level 

of confidence that a sequence listing 

authored and validated by WIPO 

Sequence will comply with the USPTO 

rules for a ‘‘Sequence Listing XML’’ (37 

CFR 1.831 through 1.835) and be 

accepted, given that the WIPO Sequence 

Validator that the USPTO will use is 

based on WIPO Standard ST.26. 


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f. Applicability 

In accordance with this final rule, an 

application that has a filing date on or 

after July 1, 2022, will be required to 

provide a ‘‘Sequence Listing XML’’ in 

accordance with 37 CFR 1.831 through 

1.835 for disclosures of any nucleotide 

and/or amino acid sequences that meet 

the definitions of 37 CFR 1.831(a) and 

(b). This includes applications having 

an international filing date on or after 

July 1, 2022, that claim benefit or 

priority to applications with filing dates 

before July 1, 2022. Such applications 

include, but are not limited to, 

applications having one or more benefit 

or priority claims under 35 U.S.C. 119(e) 

(claiming the benefit of a provisional), 

35 U.S.C. 120 (claiming the benefit as a 

continuation and/or continuation-inpart), 35 U.S.C. 121 (claiming the 

benefit as a divisional), 35 U.S.C. 365(c) 

(claiming the benefit as a continuing 

application to a PCT application), or 35 

U.S.C. 119(a)–(d) or 35 U.S.C. 365(a) 

(claiming the priority to a foreign filed 

application or a prior filed PCT). If a 

prior application to which benefit or 

priority is claimed contains a ‘‘Sequence 

Listing’’ in Standard ST.25 format (in 

compliance with 37 CFR 1.821 through 

1.825), the applicant will be required to 

convert that ‘‘Sequence Listing’’ to 

WIPO Standard ST.26 format (a 

‘‘Sequence Listing XML’’ in compliance 

with 37 CFR 1.831 through 1.835) for 

inclusion in the new application filed 

on or after July 1, 2022. 

As provided in 35 U.S.C. 363, the 

filing date of an international stage 

application is also the filing date for the 

national stage application filed under 35 

U.S.C. 371. Accordingly, for 

applications submitted under 35 U.S.C. 

371, WIPO Standard ST.26 will apply to 

such applications based on the 

international filing date of the 

corresponding international application, 

rather than the date of submission of the 

national stage application in the 

USPTO. 

Compliance with 37 CFR 1.831 

through 1.835 (rules based on WIPO 

Standard ST.26) is also applicable to 

any reissue application filed on or after 

July 1, 2022, where the disclosure or 

claims contain nucleotide and/or amino 

acid sequences as defined in 37 CFR 

1.831(a) or (b). The filing date of the 

originally granted patent for which 

reissue is sought is not relevant in 

determining the applicability date of 

this final rule. 

Relying on the actual filing date of an 

application to determine whether 

sequence information must conform to 

37 CFR 1.821 through 1.825 (rules based 

on Standard ST.25) or 37 CFR 1.831 

through 1.835 (rules based on WIPO 

Standard ST.26) will simplify the 

application of the sequence rules, both 

for the USPTO and the applicant. 

Though 37 CFR 1.821 through 1.825 are 

not revised by this final rule, note that 

37 CFR 1.821 through 1.825 will not be 

applicable to applications filed on or 

after July 1, 2022, as a result of this final 

rule. 

For applications filed on or after July 

1, 2022, the USPTO patent electronic 

filing system will prohibit an applicant 

from submitting both a ‘‘Sequence 

Listing XML’’ (a sequence listing that 

conforms to WIPO Standard ST.26 as 

implemented in 37 CFR 1.831 through 

1.835) and a ‘‘Sequence Listing’’ (a 

sequence listing that conforms to ST.25 

as implemented in 37 CFR 1.821 

through 1.825) in the same submission. 

Filing a ‘‘Sequence Listing’’ in an 

application filed on or after July 1, 2022, 

will result in a notice informing 

applicant that the submission fails to 

comply with 37 CFR 1.831 through 

1.834 and will require submission of a 

‘‘Sequence Listing XML.’’ 

While implementing regulations and 

procedures for ST.26, the USPTO 

recognized that an applicant might 

erroneously provide a ‘‘Sequence 

Listing’’ (one in ASCII plain text file 

format) even though a ‘‘Sequence 

Listing XML’’ is required. Therefore, in 

the rare circumstance in which a 

‘‘Sequence Listing’’ is submitted in an 

application filed on or after July 1, 2022, 

the ‘‘Sequence Listing’’ present in the 

Office file wrapper of the application at 

issue may be used to provide support 

for the submission of a compliant 

‘‘Sequence Listing XML.’’ The 

applicant’s reliance on the ‘‘Sequence 

Listing’’ to support the compliant 

‘‘Sequence Listing XML’’ would be by 

way of the safeguard under 37 CFR 

1.57(b), if an earlier filed application 

contains a proper ‘‘Sequence Listing’’ in 

.txt file format, or via a grantable 

petition under 37 CFR 1.182, only if the 

application does not have a proper 

benefit or priority claim present on the 

filing date to an earlier filed application. 

An applicant may rely on the 

provisions in 37 CFR 1.57(b), as 

described in the Manual of Patent 

Examining Procedure at section 217, to 

support the required ‘‘Sequence Listing 

XML’’ as an ‘‘inadvertently omitted 

portion of the specification or 

drawing(s).’’ To rely on 37 CFR 1.57(b), 

a compliant ‘‘Sequence Listing’’ must 

have been submitted in an earlier filed 

application to which the present 

application makes a proper benefit or 

priority claim, and the ‘‘Sequence 

Listing’’ was present on the filing date 

of the earlier filed application (i.e., the 

earlier filed application contains a 

compliant ‘‘Sequence Listing’’ 

submitted under 37 CFR 1.821(c)(1) as 

an ASCII plain text file (with a proper 

incorporation by reference statement in 

the specification), 37 CFR 1.821(c)(2) as 

a PDF copy, or 37 CF 1.821(c)(3) on 

physical sheets of paper). An applicant 

would be required to submit: (1) A 

compliant ‘‘Sequence Listing XML’’ 

under 37 CFR 1.835(a)(1); (2) a 

statement identifying where the 

inadvertently omitted portion of the 

specification can be found (e.g., 

identifying the nucleotide and/or amino 

acid sequence information in the 

compliant ‘‘Sequence Listing’’ from the 

earlier filed application that forms the 

basis for the ‘‘Sequence Listing XML’’), 

see 37 CFR 1.835(a)(3); (3) a statement 

identifying the nucleotide and/or amino 

acid sequences of the ‘‘Sequence 

Listing,’’ submitted (in the earlier filed 

application) under 37 CFR 1.821(c)(1) as 

an ASCII plain text file (with a proper 

incorporation by reference statement in 

the specification), 37 CFR 1.821(c)(2) as 

a PDF copy, or 37 CFR 1.821(c)(3) as 

physical sheets of paper, which forms 

the basis for the compliant ‘‘Sequence 

Listing XML’’; (4) a statement that the 

‘‘Sequence Listing XML’’ does not 

introduce new matter into the 

application, see 37 CFR 1.835(a)(4); and 

(5) a statement that all or a portion of 

the specification or drawings, as found 

in the ‘‘Sequence Listing XML,’’ were 

inadvertently omitted from the 

application. The availability of relief 

under 37 CFR 1.57(b) precludes the 

filing of a grantable petition under 37 

CFR 1.182 seeking the same relief. 

A petition under 37 CFR 1.182 would 

require: (1) A compliant ‘‘Sequence 

Listing XML’’ under 37 CFR 1.835(a)(1); 

(2) a statement identifying the 

nucleotide and/or amino acid sequence 

information of the ‘‘Sequence Listing’’ 

submitted as an ASCII plain text file 

that forms the basis for the ‘‘Sequence 

Listing XML’’ (i.e., identifying the 

nucleotide and/or amino acid sequence 

information found in the ‘‘Sequence 

Listing’’ from the earlier submitted 

ASCII ‘‘Sequence Listing’’) that is relied 

on for submission of a compliant 

‘‘Sequence Listing XML,’’ see 37 CFR 

1.835(a)(3); and (3) a statement that the 

‘‘Sequence Listing XML’’ does not 

introduce new matter into the 

application, as required by 37 CFR 

1.835(a)(4). In such circumstances, for 

record retention purposes, any 

‘‘Sequence Listing’’ submitted as an 

ASCII plain text file will be retained in 

the official record for the application. 


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II. Discussion of Specific Rules 

Section 1.52: Section 1.52 (e)(1)(ii) is 

amended to include reference to a 

‘‘Sequence Listing XML’’ submitted 

under § 1.831(a) in compliance with 

§§ 1.832 through 1.834. 

Section 1.52(e)(3)(iii) is amended to 

more explicitly indicate that the 

contents of each read-only optical disc 

must be in ASCII plain text and if 

compressed, must be compressed in 

accordance with § 1.58 for ‘‘Large 

Tables,’’ § 1.96 for a ‘‘Computer Program 

Listing Appendix,’’ or § 1.824 for a 

‘‘Sequence Listing’’ or CRF of the 

‘‘Sequence Listing,’’ as applicable. 

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

require that the contents of each readonly 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) is amended to add 

that any amendment to the information 

on a read-only optical disc previously 

submitted in relation to a ‘‘Sequence 

Listing XML’’ must be made by way of 

a replacement read-only optical disc in 

accordance with § 1.835(b). 

Section 1.52(f)(1) is amended to add 

that any XML file submitted on a readonly 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 

as ‘‘any sequence listing.’’ 

Section 1.52(f)(1)(i) is amended to 

reference any ‘‘Sequence Listing XML’’ 

in compliance with § 1.831(a). 

Section 1.52(f)(2) is amended to 

indicate that any XML file, submitted 

via the USPTO patent electronic filing 

system for a ‘‘Sequence Listing XML’’ in 

compliance with § 1.831(a) is excluded 

from the application size fee 

determination. The provision at 35 

U.S.C. 41(a)(1)(G) provides the basis for 

excluding ‘‘any sequence listing,’’ when 

filed in an electronic medium, from the 

application size fee determination. A 

‘‘Sequence Listing XML’’ is considered 

as ‘‘any sequence listing.’’ 

Section 1.52(f)(2)(i) is amended to add 

a reference to any ‘‘Sequence Listing 

XML’’ in compliance with § 1.831(a). 

Section 1.52(f)(3) is amended to add 

that any ‘‘Sequence Listing XML’’ of 300 

MB–800 MB is subject to the surcharge 

set forth in § 1.21(o)(1) and also add that 

any ‘‘Sequence Listing XML’’ over 800 

MB is subject to the surcharge set forth 

in § 1.21(o)(2). 

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

revised to indicate that a separate 

sequence listing in a provisional 

application disclosing nucleotide and/or 

amino acid sequences is not required, 

but any biological sequence data 

submitted in a provisional application 

filed on or after July 1, 2022, must be 

a ‘‘Sequence Listing XML’’ in 

compliance with §§ 1.831 through 

1.834. This change does not apply to 

provisional applications filed before 

July 1, 2022. 

Section 1.77: Section 1.77(b)(5) is 

amended to reorganize the provisions to 

§ 1.77(b)(5)(i) for an incorporation by 

reference statement for ASCII plain text 

files 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) is added to provide 

for the provisions for an incorporation 

by reference statement for a ‘‘Sequence 

Listing XML’’ submitted via the USPTO 

patent electronic filing system or on one 

or more read-only optical discs. 

Section 1.121: Section 1.121(b) is 

amended to revise the reference for a 

‘‘Sequence Listing’’ and eliminate the 

reference to a CRF of a ‘‘Sequence 

Listing,’’ since a separate CRF (under 

§ 1.821(e)(1) or (2)) is not part of the 

specification. The amendment also adds 

an exception to amendment practice for 

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

Section 1.121(b)(6) is amended 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) is amended to include 

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

Section 1.173(b)(1)(i) is amended to 

add an exception to reissue amendment 

practice for a ‘‘ ‘Sequence Listing XML’ 

(§ 1.831(a)).’’ 

Section 1.173(b)(1)(ii) is amended to 

provide that changes to a ‘‘Sequence 

Listing XML’’ must be made in 

accordance with § 1.835. 

Section 1.173(d) is amended to add a 

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

among the items that are excluded from 

the manner of making amendments in a 

reissue application. Reference to 

specific CFR provisions for ‘‘Large 

Tables’’ (§ 1.58(c)), a ‘‘Computer 

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

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

were added. 

Section 1.211: Section 1.211(c) is 

amended to add a ‘‘Sequence Listing’’ in 

compliance with §§ 1.821 through 1.825 

(if applicable) for an application filed 

before July 1, 2022, and a ‘‘Sequence 

Listing XML’’ in compliance with 

§§ 1.831 through 1.835 (if applicable) for 

an application filed on or after July 1, 

2022, to the currently listed items that 

may delay application publication if not 

present. 

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

amended to delineate between 

translations needed for a sequence 

listing in international applications 

entering the national stage in the United 

States and having an international filing 

date before July 1, 2022, and a sequence 

listing in XML format for international 

applications entering the national stage 

in the United States and having an 

international filing date on or after July 

1, 2022. Specifically, the amendment 

indicates that a sequence listing need 

not be translated for national stage entry 

if it complies with PCT Rule 12.1(d) and 

the description complies with PCT Rule 

5.2(b) for applications having an 

international filing date before July 1, 

2022. However, the amendment 

indicates that a sequence listing in XML 

format must be translated for national 

stage entry if it was submitted in an 

international application having an 

international filing date on or after July 

1, 2022, with non-English language 

values for any language-dependent free 

text qualifiers. Note that an invention 

title is not considered a ‘‘languagedependent free text qualifier’’ for 

purposes of this rule, and translation of 

the invention title is not required. 

Section 1.495(c)(5), as well as 

§§ 1.833(b)(3) and 1.835(d)(2) as 

discussed below, were proposed to 

require that the ‘‘Sequence Listing 

XML’’ contain at least one invention 

title in English. This proposal has not 

been adopted in this final rule. The 

proposed requirement for a translation 

of the title into English was not adopted 

in the final rule because applicants in 

the international phase need only 

provide a title in the language of filing, 

which can be in a language other than 

English. 

Section 1.530: The heading of 

§ 1.530(d)(1) is amended to include 

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

Section 1.530(d)(1)(i) is amended to 

add an exception to reexamination 

amendment practice for a ‘‘ ‘Sequence 

Listing XML’ (§ 1.831(a)).’’ 

Section 1.530(d)(1)(ii) is amended to 

provide that changes to a ‘‘Sequence 

Listing XML’’ must be made in 

accordance with § 1.835. 

Section 1.704: Section 1.704(f) is 

amended to add a ‘‘Sequence Listing 

XML’’ in compliance with §§ 1.831 

through 1.835 (if applicable) to the list 

of items required for an application filed 

under 35 U.S.C. 111(a) to be in 

condition for examination for purposes 

of calculating a reduction in patent term 

adjustment. The amendment also adds a 

‘‘Sequence Listing XML’’ in compliance 


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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 amended to add a ‘‘Sequence 

Listing XML’’ in compliance with 

§§ 1.831 through 1.835 (if applicable) to 

the current list of items required for an 

application to be considered compliant, 

for purposes of determining a patent 

term adjustment reduction, on the filing 

date of the latest reply (if any) correcting 

the papers, drawings, or ‘‘Sequence 

Listing’’ that is prior to the date of the 

mailing of either an action under 35 

U.S.C. 132 or a notice of allowance 

under 35 U.S.C. 151, whichever occurs 

first. Lastly, the term ‘‘Sequence 

Listing’’ replaces ‘‘sequence listing,’’ 

since §§ 1.821 through 1.825 specifically 

define a ‘‘Sequence Listing.’’ 

Section 1.831: Section 1.831 is added 

to provide the heading of ‘‘requirements 

for patent applications filed on or after 

July 1, 2022, having disclosures of 

nucleotide and/or amino acid 

sequences.’’ 

Section 1.831(a) is added to specify 

that patent applications disclosing 

nucleotide and/or amino acid sequences 

by enumeration of their residues, as 

defined in paragraph (b) of the section, 

must contain, as a separate part of the 

disclosure, a ‘‘Sequence Listing XML’’. 

Disclosed nucleotide and/or amino acid 

sequences that do not meet the 

definition in paragraph (b) of the section 

must not be included in the ‘‘Sequence 

Listing XML.’’ The ‘‘Sequence Listing 

XML’’ contains information of the 

nucleotide and/or amino acid sequences 

disclosed in the patent application 

using the symbols and format in 

accordance with the requirements of 

§§ 1.832 through 1.834. 

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

to define the nucleotide and amino acid 

sequences for which a ‘‘Sequence 

Listing XML’’ is required. Specifically, 

nucleotide and/or amino acid 

sequences, as used in these rules, 

encompass: an unbranched sequence or 

linear region of a branched sequence 

containing 4 or more specifically 

defined amino acids, wherein the amino 

acids form a single peptide backbone or 

an unbranched sequence or linear 

region of a branched sequence of 10 or 

more specifically defined nucleotides, 

wherein adjacent nucleotides are joined 

by a 3′ to 5′ (or 5′ to 3′) phosphodiester 

linkage or, for nucleotide analogs, any 

chemical bond that results in an 

arrangement of adjacent nucleobases 

that mimics the arrangement of 

nucleobases in naturally occurring 

nucleic acids. 

Section 1.831(c) is added to state that, 

where the description or claims of a 

patent application discuss a nucleotide 

and/or amino acid sequence that is set 

forth in the ‘‘Sequence Listing XML’’ in 

accordance with paragraph (a) of the 

section, reference must be made to the 

sequence by use of the sequence 

identifier, preceded by ‘‘SEQ ID NO:’’ or 

the like, in the text of the description or 

claims, even if the sequence is also 

embedded in the text of the description 

or claims of the patent application. 

Where a sequence is presented in a 

drawing, reference must be made to the 

sequence by use of the sequence 

identifier (§ 1.832(a)), either in the 

drawing or in the Brief Description of 

the Drawings, where the correlation 

between multiple sequences in the 

drawing and their sequence identifiers 

(§ 1.832(a)) in the Brief Description is 

clear. The use of SEQ ID NO: Is 

preferred, but including ‘‘or the like’’ is 

intended to ensure that a formalities 

notice is not sent when an application 

uses, for example, ‘‘SEQ NO.’’ or ‘‘Seq. 

Id. No.’’ or any similar identification of 

an amino acid or nucleotide sequence in 

the description or claims where it is 

clear that a sequence from the 

‘‘Sequence Listing XML’’ is shown in 

the description, claims, or drawings. 

When identifying the sequence in the 

description, claims, or drawings, the 

numeric sequence identifier from the 

‘‘Sequence Listing XML’’ must identify 

the same sequence. 

Section 1.831(d) is added to define 

the expression ‘‘enumeration of its 

residues,’’ consistent with the definition 

in paragraph 3(c)(i) or (ii) of WIPO 

Standard ST.26 (incorporated by 

reference, see 37 CFR 1.839). 

Section 1.831(e) is added to define the 

expression ‘‘specifically defined,’’ 

consistent with the definition in 

paragraph 3(k) of WIPO Standard ST.26. 

Section 1.831(f) is added to define the 

expression ‘‘amino acid,’’ consistent 

with the definition in paragraph 3(a) of 

WIPO Standard ST.26. 

Section 1.831(g) is added to define the 

expression ‘‘modified amino acid,’’ 

consistent with the definition in 

paragraph 3(e) of WIPO Standard ST.26. 

Section 1.831(h) is added to define 

the expression ‘‘nucleotide,’’ consistent 

with paragraphs 3(f) and 3(g) of WIPO 

Standard ST.26. 

Section 1.831(i) is added to define the 

expression ‘‘modified nucleotide,’’ 

consistent with paragraph 3(f) of WIPO 

Standard ST.26. 

Section 1.831(j) is added to indicate 

that a ‘‘Sequence Listing XML’’ must not 

include any sequences having fewer 

than 10 specifically defined nucleotides, 

or fewer than 4 specifically defined 

amino acids. Even though § 1.831(a) 

states that ‘‘[d]isclosed nucleotide or 

amino acid sequences that do not meet 

the definition in paragraph (b) of this 

section must not be included in the 

‘‘Sequence Listing XML,’’ ’’ adding 

§ 1.831(j) makes explicit the prohibition 

of including such sequences in the 

‘‘Sequence Listing XML.’’ 

Section 1.832: Section 1.832 is added 

to provide the manner in which a 

nucleotide and/or amino acid sequence 

is represented in the ‘‘Sequence Listing 

XML’’ part of a patent application 

having a filing date on or after July 1, 

2022. 

Section 1.832(a) is added to define the 

requirements for the representation of 

sequences in the ‘‘Sequence Listing 

XML’’ part of the application. 

Specifically, each nucleotide and/or 

amino acid sequence represented in the 

‘‘Sequence Listing XML’’ must be 

assigned a separate sequence identifier, 

and sequence identifiers must begin 

with the number 1 and increase 

sequentially by integers, as defined in 

paragraph 10 of WIPO Standard ST.26 

(incorporated by reference, see 37 CFR 

1.839). 

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

added to define the requirements for the 

representation of nucleotide sequence 

data in the ‘‘Sequence Listing XML.’’ 

Specifically, a nucleotide sequence 

must be represented in the manner 

described in paragraphs 11–12 of WIPO 

Standard ST.26. All nucleotides, 

including nucleotide analogs, modified 

nucleotides, and ‘‘unknown’’ 

nucleotides, within a nucleotide 

sequence must be represented and 

described using symbols in the manner 

described in paragraphs 13–19 and 21 of 

WIPO Standard ST.26. For a region 

containing a known number of 

contiguous ‘‘a,’’ ‘‘c,’’ ‘‘g,’’ ‘‘t,’’ or ‘‘n’’ 

residues for which the same description 

applies, the entire region may be jointly 

described as provided in paragraph 22 

of WIPO Standard ST.26. 

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

added to define the requirements for the 

representation of amino acid sequence 

data in the ‘‘Sequence Listing XML.’’ 

Specifically, an amino acid sequence 

must be represented in the manner 

described in paragraphs 24 and 25 of 

WIPO Standard ST.26. All amino acids, 

including modified amino acids and 

‘‘unknown’’ amino acids, within an 

amino acid sequence must be 

represented and described using 

symbols in the manner described in 

paragraphs 26–30 and 32 of WIPO 

Standard ST.26. For a region containing 

a known number of contiguous ‘‘X’’ 


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residues for which the same description 

applies, the entire region may be jointly 

described as provided in paragraph 34 

of WIPO Standard ST.26. 

Section 1.832(d) is added to define 

the manner in which a single 

continuous sequence, derived from one 

or more non-contiguous segments of a 

larger sequence, or of segments from 

different sequences, must be 

represented in the ‘‘Sequence Listing 

XML,’’ as described in paragraph 35 of 

WIPO Standard ST.26. 

Section 1.832(e) is added to define the 

manner in which a nucleotide and/or 

amino acid sequence that contains 

regions of specifically defined residues 

separated by one or more regions of 

contiguous ‘‘n’’ or ‘‘X’’ residues of 

specified length must be represented in 

the ‘‘Sequence Listing XML,’’ as 

described in paragraph 36 of WIPO 

Standard ST.26. 

Section 1.832(f) is added to define the 

manner in which a nucleotide and/or 

amino acid sequence that contains 

regions of specifically defined residues 

separated by one or more gaps of an 

unknown or undisclosed number of 

residues must be represented in the 

‘‘Sequence Listing XML,’’ as described 

in paragraph 37 of WIPO Standard 

ST.26. 

Section 1.833: Section 1.833 is added 

to describe the requirements for a 

‘‘Sequence Listing XML,’’ which is 

required by § 1.831(a) for disclosures of 

nucleotides and/or amino acid 

sequences in patent applications with a 

filing date on or after July 1, 2022, to 

comply with WIPO Standard ST.26 

(incorporated by reference, see 37 CFR 

1.839). 

Section 1.833(a) is added to require 

that the ‘‘Sequence Listing XML’’ must 

be presented as a single XML 1.0 file 

and encoded using Unicode UTF–8. 

Section 1.833(a) also incorporates by 

reference paragraphs 40 and 41, and 

Annex IV of WIPO Standard ST.26 for 

character sets. 

Section 1.833(b)(1) is added to require 

that the ‘‘Sequence Listing XML’’ 

presented in accordance with § 1.833(a) 

must further be valid according to the 

DTD as presented in Annex II of WIPO 

Standard ST.26. 

Section 1.833(b)(2) is added to recite 

that a ‘‘Sequence Listing XML’’ must 

comply with the requirements of WIPO 

Standard ST.26, to include the items 

enumerated in § 1.833(b)(2)(i) through 

(v) as discussed in the following 

paragraphs. 

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

require that the ‘‘Sequence Listing 

XML’’ contain an XML declaration as 

defined in paragraph 39(a) of WIPO 

Standard ST.26. 

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

require that the ‘‘Sequence Listing 

XML’’ contain a document type 

declaration as defined in paragraph 

39(b) of WIPO Standard ST.26. 

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

require that the ‘‘Sequence Listing 

XML’’ contain a root element as defined 

in paragraph 43 of WIPO Standard 

ST.26. 

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

require that the ‘‘Sequence Listing 

XML’’ contain a general information 

part that complies with paragraphs 45, 

47, and 48 of WIPO Standard ST.26, as 

applicable. 

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

require that the ‘‘Sequence Listing 

XML’’ contain a sequence data part that 

complies with paragraphs 50–55, 57, 58, 

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

WIPO Standard ST.26, as applicable. 

Section 1.833(b)(3) is added to require 

that an INSDQualifier_value element 

includes a value for that element in 

English for each language-dependent 

free text qualifier in the ‘‘Sequence 

Listing XML,’’ as required by 

§ 1.52(b)(1)(ii), and where an 

INSDQualifier_value element is defined 

in paragraphs 76 and 85–87 of WIPO 

Standard ST.26. The proposed 

requirement for a translation of the title 

into English was not adopted in the 

final rule because applicants in the 

international phase need only provide a 

title in the language of filing, which can 

be in a language other than English. 

Section 1.834: Section 1.834 is added 

to provide details on the form and 

format for nucleotide and/or amino acid 

sequence submissions as the ‘‘Sequence 

Listing XML’’ in patent applications 

filed on or after July 1, 2022. 

Section 1.834(a) is added to indicate 

that a ‘‘Sequence Listing XML’’ in 

Unicode UTF–8 created by any means 

(e.g., text editors, nucleotide/amino acid 

sequence editors, or other custom 

computer programs) in accordance with 

§§ 1.831 through 1.833 must: (1) Be 

compatible with a PC or Mac® and with 

MS–DOS®, MS-Windows®, Mac OS®, or 

Unix®/Linux® operating systems; (2) be 

in XML format, where all permitted 

printable characters (including the 

space character) and non-printable 

(control) characters are defined in 

paragraph 40 of WIPO Standard ST.26 

(incorporated by reference, see 37 CFR 

1.839); and (3) be named as *.xml, 

where ‘‘*’’ is one character or a 

combination of characters limited to 

upper- or lowercase letters, numbers, 

hyphens, and underscores and the name 

does not exceed 60 characters in total, 

excluding the extension. No spaces or 

other types of characters are permitted 

in the file name. 

Section 1.834(b) is added to require 

that the ‘‘Sequence Listing XML’’ must 

be in a single file containing the 

sequence information and be submitted 

either: (1) Electronically via the USPTO 

patent electronic filing system, where 

the file size must not exceed 100 MB 

and file compression is not permitted; 

or (2) on read-only optical disc(s) in 

compliance with § 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 optical disc size and 

labeled in compliance with 

§ 1.52(e)(5)(vi). 

Section 1.834(c)(1) is added to require 

that when a ‘‘Sequence Listing XML’’ 

required by § 1.831(a) is submitted in 

XML file format via the USPTO patent 

electronic filing system or on a readonly optical disc (in compliance with 

§ 1.52(e)), the specification must contain 

a statement in a separate paragraph (see 

§ 1.77(b)(5)) that incorporates by 

reference the material in the XML file 

identifying: (1) The name of the file, (2) 

the date of creation, and (3) the size of 

the file in bytes, so long as § 1.834(c)(2) 

does not apply. This provision was 

added in the final rule to expressly 

require an incorporation by reference 

statement in the specification to the 

‘‘Sequence Listing XML,’’ which was 

only implicitly required by § 1.835(c). 

Section 1.834(c)(2) is added to 

indicate that if the ‘‘Sequence Listing 

XML’’ required by § 1.831(a) is 

submitted in XML file format via the 

USPTO patent electronic filing system 

or on a read-only optical disc (in 

compliance with § 1.52(e)) for an 

international application during the 

international stage, then an 

incorporation by reference statement of 

the material in the XML file is not 

required. This provision was added in 

the final rule to specifically exempt the 

requirement for an incorporation by 

reference statement in the specification 

to the ‘‘Sequence Listing XML’’ (as in 

§ 1.834(c)(1)) for a national stage 

application when the ‘‘Sequence Listing 

XML’’ constituted part of the 

international application during the 

international stage. 

Section 1.835: Section 1.835 is added 

to provide the requirements for 

submission of an amendment to add or 

replace a ‘‘Sequence Listing XML’’ for 

applications filed on or after July 1, 

2022. 


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Section 1.835(a) is added to require 

that any amendment to a patent 

application adding an initial submission 

of a ‘‘Sequence Listing XML’’ as 

required by § 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) 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. 

Section 1.835(b) is added to require 

that any amendment adding to, deleting 

from, or replacing sequence information 

in a ‘‘Sequence Listing XML’’ submitted 

as required by § 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 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 added to 

provide that, when 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 in which to comply with 

such requirements to prevent the 

abandonment of the application. This 

final rule indicates that, subject to 

§ 1.835(d)(2), any amendment to add or 

replace a ‘‘Sequence Listing XML’’ in 

response to a requirement under this 

paragraph must be submitted in 

accordance with the requirements of 

§ 1.835(a) through (c). 

Section 1.835(d)(2) is added to 

explicitly provide that compliance with 

§ 1.835(a) through (c) is not required for 

the submission of a ‘‘Sequence Listing 

XML’’ that is solely an English 

translation of a previously submitted 

‘‘Sequence Listing XML’’ that contains 

non-English values for any languagedependent free text elements (as per 

§ 1.833(b)(3)). 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 35 U.S.C. 111(a) and for 

those entering the national stage, 

respectively, this rule makes explicit 

that when a translated ‘‘Sequence 

Listing XML’’ is provided as a reply to 

a notice that the ‘‘Sequence Listing 

XML’’ contains non-English values for 

any language-dependent free text 

elements, and the translation does not 

include the deletion, addition, or 

replacement of sequence information, 

the translated ‘‘Sequence Listing XML’’ 

need not comply with the requirements 

for an amended ‘‘Sequence Listing 

XML’’ as set forth in § 1.835(a) through 

(c). The proposed requirement for a 

translation of the title into English was 

not adopted in the final rule because 

applicants in the international phase 

need only provide a title in the language 

of filing, which can be in a language 

other than English. 

Section 1.835(e) is added to provide 

that, when any of the requirements of 

§§ 1.831 through 1.834 are not satisfied 

at the time of filing an international 

application under the PCT, where the 

application is to be searched by the 

United States International Searching 

Authority or examined by the United 

States International Preliminary 

Examining Authority, the applicant may 

be sent a notice calling for compliance 

with the requirements within a 

prescribed time period. Under PCT Rule 

13ter, the applicant may provide, in 

response to such a requirement or 

otherwise, a sequence listing that is a 

‘‘Sequence Listing XML’’ in accordance 

with § 1.831(a). The ‘‘Sequence Listing 

XML’’ must be accompanied by a 

statement that the information recorded 

does not go beyond the disclosure in the 

international application as filed. In 

response to such a requirement, the late 

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

also required. If the applicant fails to 

timely provide the required ‘‘Sequence 

Listing XML,’’ the United States 

International Searching Authority shall 

search only to the extent that a 

meaningful search can be performed 

without the ‘‘Sequence Listing XML,’’ 

and the United States International 

Preliminary Examining Authority shall 

examine only to the extent that a 

meaningful examination can be 

performed without the ‘‘Sequence 

Listing XML.’’ 

Section 1.835(f) is added to provide 

that any appropriate amendments to the 

‘‘Sequence Listing XML’’ in a patent 

(e.g., by reason of reissue, 

reexamination, or certificate of 

correction) must comply with the 

requirements of paragraph (b) of this 

section. 

Section 1.839: Section 1.839 is added 

to provide the location of WIPO 

Standard ST.26 that is being 

incorporated by reference. 

III. Comments and Responses and 

Changes From Proposed Rule 

The USPTO published a proposed 

rule on July 6, 2021, at 86 FR 35432, 

soliciting public comments on the 

proposed amendments to 37 CFR part 1 

being adopted in this final rule. The 

USPTO received no comments from the 

public on the proposed rule. Even 

though no comments were received, the 


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proposed changes to §§ 1.495(c)(5), 

1.833(b)(3) and 1.835(d)(2) to require a 

title in English in the ‘‘Sequence Listing 

XML’’ were not adopted in the final 

rule. The proposed requirement for a 

translation of the title into English was 

not adopted since applicants in the 

international phase need only provide a 

title in the language of filing, which can 

be in a language other than English. 

Additionally, even though § 1.831(a) 

states that ‘‘[d]isclosed nucleotide or 

amino acid sequences that do not meet 

the definition in paragraph (b) of this 

section must not be included in the 

‘‘Sequence Listing XML,’’ ’’ § 1.831(j) 

was added to make explicit the 

prohibition of including such sequences 

in the ‘‘Sequence Listing XML.’’ Section 

1.834(c)(1) was added to expressly 

require an incorporation by reference 

statement in the specification to the 

‘‘Sequence Listing XML,’’ which was 

only implicitly required by § 1.835(c). 

Lastly, § 1.834(c)(2) was added to 

specifically exempt the requirement for 

an incorporation by reference statement 

in the specification to the ‘‘Sequence 

Listing XML’’ (as in § 1.834(c)(1)) for a 

national stage application when the 

‘‘Sequence Listing XML’’ constituted 

part of the international application 

during the international stage. 

IV. Rulemaking Considerations 

A. Administrative Procedure Act: The 

changes in this rulemaking involve rules 

of agency practice and procedure, and/ 

or interpretive rules. See Bachow 

Commc’ns Inc. v. FCC, 237 F.3d 683, 

690 (D.C. Cir. 2001) (changes to 

procedural rules are not subject to 

notice and comment review under the 

Administrative Procedure Act (APA)); 

Inova Alexandria Hosp. v. Shalala, 244 

F.3d 342, 349 (4th Cir. 2001) (rules for 

handling appeals are procedural where 

they do not change the substantive 

standard for reviewing claims); Nat’l 

Org. of Veterans’ Advocates v. Sec’y of 

Veterans Affairs, 260 F.3d 1365, 1375 

(Fed. Cir. 2001) (Substantive rules 

‘‘effect a change in existing law or 

policy or which affect individual rights 

and obligations,’’ whereas interpretative 

rules ‘‘clarify or explain existing law or 

regulation and are exempt from notice 

and comment’’ review under the APA.). 

Accordingly, prior notice and 

opportunity for public comment for the 

changes in this rulemaking were not 

required pursuant to 5 U.S.C. 553(b) or 

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

Co. v. Dudas, 536 F.3d 1330, 1336–37 

(Fed. Cir. 2008) (stating that 5 U.S.C. 

553, and thus 35 U.S.C. 2(b)(2)(B), do 

not require notice and comment 

rulemaking for ‘‘interpretative rules, 

general statements of policy, or rules of 

agency organization, procedure, or 

practice’’ (quoting 5 U.S.C. 553(b)(A))). 

However, the USPTO chose to seek 

public comment before implementing 

the rule to benefit from the public’s 

input. 

B. Regulatory Flexibility Act: For the 

reasons set forth in this notice, the 

Senior Counsel for Regulatory and 

Legislative Affairs of the USPTO has 

certified to the Chief Counsel for 

Advocacy of the Small Business 

Administration that this rule will not 

have a significant economic impact on 

a substantial number of small entities. 

See 5 U.S.C. 605(b). 

The USPTO amends the rules of 

practice to require the submission of 

biological sequence data in XML where 

the rules of practice incorporate by 

reference WIPO Standard ST.26, 

‘‘Recommended Standard for the 

Presentation of Nucleotide and Amino 

Acid Sequence Listings Using XML 

(eXtensible Markup Language),’’ 

including Annexes I–VII, version 1.5, 

approved November 5, 2021, as 

disclosed in the WIPO Handbook on 

Industrial Property Information and 

Documentation. 

This rulemaking makes more 

technical data associated with 

biotechnology inventions available to 

the public because the new rules of 

practice based on WIPO Standard ST.26 

provide for enhanced biological 

sequence data related to disclosures of 

nucleotide and/or amino acid sequences 

in patent applications. WIPO Standard 

ST.26 provides clear rules as to what 

must be included in a sequence listing 

and how sequences must be represented 

(e.g., standardization of the 

representation of modified nucleic acids 

and amino acids as well as variants 

derived from primary sequences). WIPO 

Standard ST.26 contains a guidance 

document that demonstrates the 

requirement for inclusion and 

representation of biological sequence 

data. As a result, patent applicants will 

have a clearer understanding as to the 

requirements and presentation of 

biological sequence data in a compliant 

sequence listing under WIPO Standard 

ST.26. Additionally, since WIPO 

Standard ST.26 only allows XML 

format, applicants will not be burdened 

with or confused by the requirements of 

filing a sequence listing in paper or PDF 

format, and IPOs will not be burdened 

with processing paper sequence listings 

and performing necessary checks on the 

contents of the paper documents. The 

changes in this rulemaking are largely 

procedural in nature, and do not impose 

any additional requirements or fees on 

applicants. For the foregoing reasons, 

the changes in this rule will not have a 

significant economic impact on a 

substantial number of small entities. 

C. Executive Order 12866 (Regulatory 

Planning and Review): This rulemaking 

has been determined to be not 

significant for purposes of Executive 

Order 12866 (Sept. 30, 1993). 

D. Executive Order 13563 (Improving 

Regulation and Regulatory Review): The 

USPTO has complied with Executive 

Order 13563 (Jan. 18, 2011). 

Specifically, to the extent feasible and 

applicable, the USPTO has: (1) 

Reasonably determined that the benefits 

of the rule justify its costs; (2) tailored 

the rule to impose the least burden on 

society consistent with obtaining the 

agency’s regulatory objectives; (3) 

selected a regulatory approach that 

maximizes net benefits; (4) specified 

performance objectives; (5) identified 

and assessed available alternatives; (6) 

involved the public in an open 

exchange of information and 

perspectives among experts in relevant 

disciplines, affected stakeholders in the 

private sector, and the public as a 

whole, and provided online access to 

the rulemaking docket; (7) attempted to 

promote coordination, simplification, 

and harmonization across government 

agencies and identified goals designed 

to promote innovation; (8) considered 

approaches that reduce burdens while 

maintaining flexibility and freedom of 

choice for the public; and (9) ensured 

the objectivity of scientific and 

technological information and 

processes. 

E. Executive Order 13132 

(Federalism): This rulemaking does not 

contain policies with federalism 

implications sufficient to warrant 

preparation of a Federalism Assessment 

under Executive Order 13132 (Aug. 4, 

1999). 

F. Executive Order 13175 (Tribal 

Consultation): This rulemaking will not: 

(1) Have substantial direct effects on one 

or more Indian tribes; (2) impose 

substantial direct compliance costs on 

Indian tribal governments; or (3) 

preempt tribal law. Therefore, a tribal 

summary impact statement is not 

required under Executive Order 13175 

(Nov. 6, 2000). 

G. Executive Order 13211 (Energy 

Effects): This rulemaking is not a 

significant energy action under 

Executive Order 13211 because this 

rulemaking is not likely to have a 

significant adverse effect on the supply, 

distribution, or use of energy. Therefore, 

a Statement of Energy Effects is not 

required under Executive Order 13211 

(May 18, 2001). 

H. Executive Order 12988 (Civil 

Justice Reform): This rulemaking meets 

applicable standards to minimize 


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litigation, eliminate ambiguity, and 

reduce burden as set forth in sections 

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

12988 (Feb. 5, 1996). 

I. Executive Order 13045 (Protection 

of Children): This rulemaking does not 

concern an environmental risk to health 

or safety that may disproportionately 

affect children under Executive Order 

13045 (Apr. 21, 1997). 

J. Executive Order 12630 (Taking of 

Private Property): This rulemaking will 

not affect a taking of private property or 

otherwise have taking implications 

under Executive Order 12630 (Mar. 15, 

1988). 

K. Congressional Review Act: Under 

the Congressional Review Act 

provisions of the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (5 U.S.C. 801 et seq.), the USPTO 

will submit a report containing the final 

rule and other required information to 

the United States Senate, the United 

States House of Representatives, and the 

Comptroller General of the Government 

Accountability Office. The changes in 

this rulemaking are not expected to 

result in an annual effect on the 

economy of $100 million or more, a 

major increase in costs or prices, or 

significant adverse effects on 

competition, employment, investment, 

productivity, innovation, or the ability 

of United States-based enterprises to 

compete with foreign-based enterprises 

in domestic and export markets. 

Therefore, this rulemaking is not 

expected to result in a ‘‘major rule’’ as 

defined in 5 U.S.C. 804(2). 

L. Unfunded Mandates Reform Act of 

1995: The changes set forth in this 

rulemaking do not involve a Federal 

intergovernmental mandate that will 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

of $100 million (as adjusted) or more in 

any one year, or a Federal private sector 

mandate that will result in the 

expenditure by the private sector of 

$100 million (as adjusted) or more in 

any one year, and will not significantly 

or uniquely affect small governments. 

Therefore, no actions are necessary 

under the provisions of the Unfunded 

Mandates Reform Act of 1995. See 2 

U.S.C. 1501 et seq. 

M. National Environmental Policy Act 

of 1969: This rulemaking will not have 

any effect on the quality of the 

environment and is thus categorically 

excluded from review under the 

National Environmental Policy Act of 

1969. See 42 U.S.C. 4321 et seq. 

N. National Technology Transfer and 

Advancement Act of 1995: The 

requirements of section 12(d) of the 

National Technology Transfer and 

Advancement Act of 1995 (15 U.S.C. 

272 note) are not applicable because this 

rulemaking does not contain provisions 

that involve the use of technical 

standards. 

O. Paperwork Reduction Act of 1995: 

The Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3549) requires that the 

USPTO consider the impact of 

paperwork and other information 

collection burdens imposed on the 

public. In accordance with section 

3507(d) of the Paperwork Reduction Act 

of 1995, the majority of the paperwork 

and other information collection 

burdens discussed in this rule have 

already been approved under the 

following Office of Management and 

Budget (OMB) Control Numbers: 0651– 

0024 (Sequence Listing), 0651–0031 

(Patent Processing), 0651–0032 (Initial 

Patent Applications), and 0651–0064 

(Patent Reexaminations and 

Supplemental Examinations). 

Modifications to 0651–0024 because 

of this rulemaking will be submitted to 

OMB for approval. Modifications 

include the removal of the Sequence 

Listing in Application (paper), which 

will result in an estimated reduction in 

the burden associated with this 

information collection by 5,000 

responses and 30,000 burden hours. 

These burden estimates are based on the 

current OMB approved burdens 

(response volumes) associated with this 

information collection, which may be 

different from any forecasts mentioned 

in other parts of this rule. 

The changes discussed in this rule do 

not affect the information collection 

requirements or burdens associated with 

0651–0031, 0651–0032, and 0651–0064 

listed above; therefore, the USPTO does 

not plan to take any additional actions 

on these information collections as a 

result of this rulemaking. 

Notwithstanding any other provision of 

law, no person is required to respond to, 

nor shall a person be subject to a 

penalty for failure to comply with, a 

collection of information subject to the 

requirements of the Paperwork 

Reduction Act unless that collection of 

information has a currently valid OMB 

control number. 

P. E-Government Act Compliance: 

The USPTO is committed to compliance 

with the E-Government Act to promote 

the use of the internet and other 

information technologies, to provide 

increased opportunities for citizen 

access to Government information and 

services, and for other purposes. 

List of Subjects in 37 CFR Part 1 

Administrative practice and 

procedure, Biologics, Courts, Freedom 

of information, Incorporation by 

reference, Inventions and patents, 

Reporting and recordkeeping 

requirements, Small businesses. 

For the reasons stated in the preamble 

and under the authority contained in 35 

U.S.C. 2, as amended, the USPTO 

amends 37 CFR part 1 as follows: 

PART 1—RULES OF PRACTICE IN 

PATENT CASES 

■ 1. The authority citation for 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 paragraphs (e)(1)(ii) and 

(e)(3)(ii) and (iii); 

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

■ c. Revising paragraphs (e)(7), (f)(1) 

introductory text, (f)(1)(i), (f)(2) 

introductory text, (f)(2)(i), and (f)(3). 

The revisions and addition read as 

follows: 

§ 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 

§§ 1.822 through 1.824) or a ‘‘Sequence 

Listing XML’’ (submitted under 

§ 1.831(a) in compliance with §§ 1.832 

through 1.834); or 

* * * * * 

(3) * * * 

(ii) Operating system compatibility: 

MS–DOS®, MS-Windows®, MacOS®, or 

Unix®/Linux®; 

(iii) The contents of each read-only 

optical disc must be in American 

Standard Code for Information 

Interchange (ASCII) plain text and if 

compressed, must be compressed in 

accordance with § 1.58 for ‘‘Large 

Tables,’’ with § 1.96 for a ‘‘Computer 

Program Listing Appendix,’’ or § 1.824 

for a ‘‘Sequence Listing’’ or Computer 

Readable Form (CRF) of the ‘‘Sequence 

Listing,’’ as applicable; and 

(iv) The contents of each read-only 

optical disc for a ‘‘Sequence Listing 

XML’’ must be in eXtensible Markup 

Language (XML) file format, and if 

compressed, must be compressed in 

accordance with § 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 CRF of a ‘‘Sequence Listing,’’ 

and § 1.835(b) for a ‘‘Sequence Listing 

XML.’’ 

* * * * * 


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(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 for the 

application when entered into the Office 

records after being rendered by the 

USPTO patent electronic filing system. 

Excluded from this determination is any 

ASCII plain text file or any XML file (as 

applicable) submitted via the USPTO 

patent electronic filing system 

containing: 

(i) Any ‘‘Sequence Listing’’ or CRF of 

a ‘‘Sequence Listing’’ in compliance 

with § 1.821(c)(1) 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. 

* * * * * 

(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 July 1, 2022, 

any submission of nucleotide and/or 

amino acid sequence data must be by 

way of a ‘‘Sequence Listing XML’’ in 

compliance with §§ 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 in: 

(i) One or more ASCII plain text files, 

submitted via the USPTO patent 

electronic filing system or on one or 

more read-only optical discs (see 

§ 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) An XML file for a ‘‘Sequence 

Listing XML’’ (see § 1.831(a)), 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. 

* * * * * 

■ 5. Section 1.121 is amended by 

revising paragraphs (b) introductory text 

and (b)(6) to 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’’ (§ 1.825), 

or a ‘‘Sequence Listing XML’’ (§ 1.835), 

must be made by adding, deleting, or 

replacing a paragraph; by replacing a 

section; or by providing a substitute 

specification, in the manner specified in 

this section. 

* * * * * 

(6) Amendments to ‘‘Large Tables,’’ a 

‘‘Computer Program Listing Appendix,’’ 

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

Listing XML.’’ Changes to ‘‘Large 

Tables,’’ a ‘‘Computer Program Listing 

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

‘‘Sequence Listing XML’’ must be made 

in accordance with § 1.58(g) for ‘‘Large 

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

Program Listing Appendix,’’ § 1.825 for 

a ‘‘Sequence Listing,’’ or § 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’’ (§ 1.58(c)), a 

‘‘Computer Program Listing Appendix’’ 

(§ 1.96(c)), a ‘‘Sequence Listing’’ 

(§ 1.821(c)), and a ‘‘Sequence Listing 

XML’’ (§ 1.831(a)) 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: 


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§ 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 July 1, 2022, a 

‘‘Sequence Listing XML’’ in compliance 

with §§ 1.831 through 1.835 (if 

applicable) for an application filed on or 

after July 1, 2022, and the inventor’s 

oath or declaration or application data 

sheet containing the information 

specified in § 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) For international applications 

having an international filing date 

before July 1, 2022, a sequence listing 

need not be translated if the sequence 

listing complies with PCT Rule 12.1(d) 

and the description complies with PCT 

Rule 5.2(b). For international 

applications having an international 

filing date on or after July 1, 2022, for 

purposes of paragraph (c)(1)(i) of this 

section, an English translation is 

required for any sequence listing in 

XML format (‘‘Sequence Listing XML’’) 

containing non-English language values 

for any language-dependent free text 

qualifiers in accordance with §§ 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 

‘‘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,’’ or § 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 it 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 it 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), an 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, ‘‘Sequence Listing,’’ 

or ‘‘Sequence Listing XML’’ that is prior 

to the date of mailing of either an action 

under 35 U.S.C. 132 or a notice of 

allowance under 35 U.S.C. 151, 

whichever occurs first. 

■ 11. Sections 1.831 through 1.835 and 

1.839 are added to read as follows: 

Sec. 

* * * * * 

1.831 Requirements for patent applications 

filed on or after July 1, 2022, having 

nucleotide and/or amino acid sequence 

disclosures. 

1.832 Representation of nucleotide and/or 

amino acid sequence data in the 

‘‘Sequence Listing XML’’ part of a patent 

application filed on or after July 1, 2022. 

1.833 Requirements for a ‘‘Sequence Listing 

XML’’ for nucleotide and/or amino acid 

sequences as part of a patent application 

filed on or after July 1, 2022. 

1.834 Form and format for nucleotide and/ 

or amino acid sequence submissions as 

the ‘‘Sequence Listing XML’’ in patent 

applications filed on or after July 1, 

2022. 

1.835 Amendment to add or replace a 

‘‘Sequence Listing XML’’ in patent 

applications filed on or after July 1, 

2022. 

1.839 Incorporation by reference. 

* * * * * 

§ 1.831 Requirements for patent 

applications filed on or after July 1, 2022, 

having nucleotide and/or amino acid 

sequence disclosures. 

(a) Patent applications disclosing 

nucleotide and/or amino acid sequences 

by enumeration of their residues, as 

defined in paragraph (b) of this section, 

must contain, as a separate part of the 

disclosure, a computer readable 

Sequence Listing in XML format (a 

‘‘Sequence Listing XML’’). Disclosed 

nucleotide or amino acid sequences that 

do not meet the definition in paragraph 

(b) of this section must not be included 

in the ‘‘Sequence Listing XML.’’ The 

‘‘Sequence Listing XML’’ contains the 

information of the nucleotide and/or 

amino acid sequences disclosed in the 

patent application using the symbols 

and format in accordance with the 

requirements of §§ 1.832 through 1.834. 


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(b) Nucleotide and/or amino acid 

sequences, as used in this section and 

§§ 1.832 through 1.835, encompass: 

(1) An unbranched sequence or linear 

region of a branched sequence 

containing 4 or more specifically 

defined amino acids, wherein the amino 

acids form a single peptide backbone; or 

(2) An unbranched sequence or linear 

region of a branched sequence of 10 or 

more specifically defined nucleotides, 

wherein adjacent nucleotides are joined 

by: 

(i) A 3′ to 5′ (or 5′ to 3′) 

phosphodiester linkage; or 

(ii) Any chemical bond that results in 

an arrangement of adjacent nucleobases 

that mimics the arrangement of 

nucleobases in naturally occurring 

nucleic acids (i.e., nucleotide analogs). 

(c) Where the description or claims of 

a patent application discuss a sequence 

that is set forth in the ‘‘Sequence Listing 

XML’’ in accordance with paragraph (a) 

of this section, reference must be made 

to the sequence by use of the sequence 

identifier, preceded by ‘‘SEQ ID NO:’’ or 

the like in the text of the description or 

claims, even if the sequence is also 

embedded in the text of the description 

or claims of the patent application. 

Where a sequence is presented in a 

drawing, reference must be made to the 

sequence by use of the sequence 

identifier (§ 1.832(a)), either in the 

drawing or in the Brief Description of 

the Drawings, where the correlation 

between multiple sequences in the 

drawing and their sequence identifiers 

(§ 1.832(a)) in the Brief Description is 

clear. 

(d) ‘‘Enumeration of its residues’’ 

means disclosure of a nucleotide or 

amino acid sequence in a patent 

application by listing, in order, each 

residue of the sequence, where the 

residues are represented in the manner 

as defined in paragraph 3(c)(i) or (ii) of 

WIPO Standard ST.26 (incorporated by 

reference, see § 1.839). 

(e) ‘‘Specifically defined’’ means any 

amino acid or nucleotide as defined in 

paragraph 3(k) of WIPO Standard ST.26. 

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

L-amino acid or modified amino acid as 

defined in paragraph 3(a) of WIPO 

Standard ST.26. 

(g) ‘‘Modified amino acid’’ includes 

any amino acid as described in 

paragraph 3(e) of WIPO Standard ST.26. 

(h) ‘‘Nucleotide’’ includes any 

nucleotide, nucleotide analog, or 

modified nucleotide as defined in 

paragraphs 3(f) and 3(g) of WIPO 

Standard ST.26. 

(i) ‘‘Modified nucleotide’’ includes 

any nucleotide as described in 

paragraph 3(f) of WIPO Standard ST.26. 

(j) A ‘‘Sequence listing XML’’ must 

not include any sequences having fewer 

than 10 specifically defined nucleotides, 

or fewer than 4 specifically defined 

amino acids. 

§ 1.832 Representation of nucleotide and/ 

or amino acid sequence data in the 

‘‘Sequence Listing XML’’ part of a patent 

application filed on or after July 1, 2022. 

(a) Each disclosed nucleotide or 

amino acid sequence that meets the 

requirements of § 1.831(b) must appear 

separately in the ‘‘Sequence Listing 

XML.’’ Each sequence set forth in the 

‘‘Sequence Listing XML’’ must be 

assigned a separate sequence identifier. 

The sequence identifiers must begin 

with 1 and increase sequentially by 

integers as defined in paragraph 10 of 

WIPO Standard ST.26 (incorporated by 

reference, see § 1.839). 

(b) The representation and symbols 

for nucleotide sequence data shall 

conform to the requirements of 

paragraphs (b)(1) through (4) of this 

section. 

(1) A nucleotide sequence must be 

represented in the manner described in 

paragraphs 11–12 of WIPO Standard 

ST.26. 

(2) All nucleotides, including 

nucleotide analogs, modified 

nucleotides, and ‘‘unknown’’ 

nucleotides, within a nucleotide 

sequence must be represented using the 

symbols set forth in paragraphs 13–16, 

19, and 21 of WIPO Standard ST.26. 

(3) Modified nucleotides within a 

nucleotide sequence must be described 

in the manner discussed in paragraphs 

17, 18, and 19 of WIPO Standard ST.26. 

(4) A region containing a known 

number of contiguous ‘‘a,’’ ‘‘c,’’ ‘‘g,’’ ‘‘t,’’ 

or ‘‘n’’ residues for which the same 

description applies may be jointly 

described in the manner described in 

paragraph 22 of WIPO Standard ST.26. 

(c) The representation and symbols 

for amino acid sequence data shall 

conform to the requirements of 

paragraphs (c)(1) through (4) of this 

section. 

(1) The amino acids in an amino acid 

sequence must be represented in the 

manner described in paragraphs 24 and 

25 of WIPO Standard ST.26. 

(2) All amino acids, including 

modified amino acids and ‘‘unknown’’ 

amino acids, within an amino acid 

sequence must be represented using the 

symbols set forth in paragraphs 26–29 

and 32 of WIPO Standard ST.26. 

(3) Modified amino acids within an 

amino acid sequence must be described 

in the manner discussed in paragraphs 

29 and 30 of WIPO Standard ST.26. 

(4) A region containing a known 

number of contiguous ‘‘X’’ residues for 

which the same description applies may 

be jointly described in the manner 

described in paragraph 34 of WIPO 

Standard ST.26. 

(d) A nucleotide and/or amino acid 

sequence that is constructed as a single 

continuous sequence derived from one 

or more non-contiguous segments of a 

larger sequence or of segments from 

different sequences must be listed in the 

‘‘Sequence Listing XML’’ in the manner 

described in paragraph 35 of WIPO 

Standard ST.26. 

(e) A nucleotide and/or amino acid 

sequence that contains regions of 

specifically defined residues separated 

by one or more regions of contiguous 

‘‘n’’ or ‘‘X’’ residues, wherein the exact 

number of ‘‘n’’ or ‘‘X’’ residues in each 

region is disclosed, must be listed in the 

‘‘Sequence Listing XML’’ in the manner 

described in paragraph 36 of WIPO 

Standard ST.26. 

(f) A nucleotide and/or amino acid 

sequence that contains regions of 

specifically defined residues separated 

by one or more gaps of an unknown or 

undisclosed number of residues must be 

listed in the ‘‘Sequence Listing XML’’ in 

the manner described in paragraph 37 of 

WIPO Standard ST.26. 

§ 1.833 Requirements for a ‘‘Sequence 

Listing XML’’ for nucleotide and/or amino 

acid sequences as part of a patent 

application filed on or after July 1, 2022. 

(a) The ‘‘Sequence Listing XML’’ as 

required by § 1.831(a) must be presented 

as a single file in XML 1.0 encoded 

using Unicode UTF–8, where the 

character set complies with paragraphs 

40 and 41 and Annex IV of WIPO 

Standard ST.26 (incorporated by 

reference, see § 1.839). 

(b) The ‘‘Sequence Listing XML’’ 

presented in accordance with paragraph 

(a) of this section must further: 

(1) Be valid according to the 

Document Type Definition (DTD) as 

presented in WIPO Standard ST.26, 

Annex II. 

(2) Comply with the requirements of 

WIPO Standard ST.26 to include: 

(i) An XML declaration as defined in 

paragraph 39(a) of WIPO Standard 

ST.26; 

(ii) A document type (DOCTYPE) 

declaration as defined in paragraph 

39(b) of WIPO Standard ST.26; 

(iii) A root element as defined in 

paragraph 43 of WIPO Standard ST.26; 

(iv) A general information part that 

complies with the requirements of 

paragraphs 45, 47, and 48, as applicable, 

of WIPO Standard ST.26; and 

(v) A sequence data part that complies 

with the requirements of paragraphs 50– 

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

and 100, as applicable, of WIPO 


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Standard ST.26 representing the 

nucleotide and/or amino acid sequences 

according to § 1.832. 

(3) Include an INSDQualifier_value 

element with a value in English for any 

language-dependent free text qualifier as 

defined by paragraphs 76 and 85–87 of 

WIPO Standard ST.26, and as required 

by § 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 July 1, 2022. 

(a) A ‘‘Sequence Listing XML’’ 

encoded using Unicode UTF–8, created 

by any means (e.g., text editors, 

nucleotide/amino acid sequence editors, 

or other custom computer programs) in 

accordance with §§ 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 paragraph 40 of WIPO 

Standard ST.26 (incorporated by 

reference, see § 1.839). 

(3) Be named as *.xml, where ‘‘*’’ is 

one character or a combination of 

characters limited to upper- or 

lowercase letters, numbers, hyphens, 

and underscores, and the name does not 

exceed 60 characters in total, excluding 

the extension. No spaces or other types 

of characters are permitted in the file 

name. 

(b) The ‘‘Sequence Listing XML’’ must 

be in a single file containing the 

sequence information and be submitted 

either: 

(1) Electronically via the USPTO 

patent electronic filing system, where 

the file size must not exceed 100 MB, 

and file compression is not permitted; 

or 

(2) On read-only optical disc(s) in 

compliance with § 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; or 

(iv) A compressed XML file that does 

not fit on a single read-only optical disc 

may be split into multiple file parts, in 

accordance with the target read-only 

optical disc size, and labeled in 

compliance with § 1.52(e)(5)(vi); 

(c)(1) Unless paragraph (c)(2) of this 

section applies, when the ‘‘Sequence 

Listing XML’’ required by § 1.831(a) is 

submitted in XML file format via the 

USPTO patent electronic filing system 

or on a read-only optical disc (in 

compliance with § 1.52(e)), then the 

specification must contain a statement 

in a separate paragraph (see § 1.77(b)(5)) 

that incorporates by reference the 

material in the XML file identifying: 

(i) The name of the file; 

(ii) The date of creation; and 

(iii) The size of the file in bytes; or 

(2) If the ‘‘Sequence Listing XML’’ 

required by § 1.831(a) is submitted in 

XML file format via the USPTO patent 

electronic filing system or on a readonly optical disc (in compliance with 

§ 1.52(e)) for an international 

application during the international 

stage, then an incorporation by 

reference statement of the material in 

the XML file is not required. 

§ 1.835 Amendment to add or replace a 

‘‘Sequence Listing XML’’ in patent 

applications filed on or after July 1, 2022. 

(a) Any amendment to a patent 

application adding an initial submission 

of a ‘‘Sequence Listing XML’’ as 

required by § 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, which 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 the replaced ‘‘Sequence 

Listing XML’’; 

(4) A statement that indicates the 

support for the additions, deletions, or 

replacements of the sequence 

information, with specific references to 

particular parts of the application as 

originally filed (specification, claims, 

drawings) for all amended sequence 

data in the replacement ‘‘Sequence 

Listing XML’’; and 

(5) A statement that the replacement 

‘‘Sequence Listing XML’’ includes no 

new matter. 

(c) The specification of a complete 

application, filed on the application 

filing date, with a ‘‘Sequence Listing 

XML’’ as required under § 1.831(a), 

without an incorporation by reference of 

the material contained in the ‘‘Sequence 

Listing XML’’ file, must be amended to 

include a separate paragraph 

incorporating by reference the material 

contained in the ‘‘Sequence Listing 

XML’’ file, in accordance with 

§ 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’’ or add an 

incorporation by reference of the 

material contained in the ‘‘Sequence 

Listing XML’’ in response to a 

requirement under this paragraph (d)(1) 

must be submitted in accordance with 

the requirements of paragraphs (a) 

through (c) of this section. 


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Federal Register / Vol. 87, No. 98 / Friday, May 20, 2022 / Rules and Regulations 30821 

(2) Compliance with paragraphs (a) 

through (c) of this section is not 

required for submission of a ‘‘Sequence 

Listing XML’’ that is solely an English 

translation of a previously submitted 

‘‘Sequence Listing XML’’ that contains 

non-English values for any languagedependent free text elements (as per 

§ 1.833(b)(3)). 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, the applicant can 

provide, in response to such a 

requirement or otherwise, a sequence 

listing that 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. In 

response to such a requirement, the late 

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

also required. If the applicant fails to 

timely provide the required ‘‘Sequence 

Listing XML,’’ the United States 

International Searching Authority shall 

search only to the extent that a 

meaningful search can be performed 

without the ‘‘Sequence Listing XML,’’ 

and the United States International 

Preliminary Examining Authority shall 

examine only to the extent that a 

meaningful examination can be 

performed without the ‘‘Sequence 

Listing XML.’’ 

(f) Any appropriate amendments to 

the ‘‘Sequence Listing XML’’ in a patent 

(e.g., by reason of reissue, 

reexamination, or certificate of 

correction) must comply with the 

requirements of paragraph (b) of this 

section. 

§ 1.839 Incorporation by reference. 

(a) Certain material is incorporated by 

reference into this subpart with the 

approval of the Director of the Federal 

Register under 5 U.S.C. 552(a) and 1 

CFR part 51. All approved incorporation 

by reference (IBR) material is available 

for inspection at the USPTO and at the 

National Archives and Records 

Administration (NARA). Contact the 

USPTO’s Office of Patent Legal 

Administration at 571–272–7701. For 

information on the availability of this 

material at NARA, email fr.inspection@

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

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

The material may be obtained from the 

source(s) in paragraph (b) of this 

section. 

(b) World Intellectual Property 

Organization (WIPO), 34 chemin des 

Colombettes, 1211 Geneva 20 

Switzerland, www.wipo.int. 

(1) WIPO Standard ST.26. WIPO 

Handbook on Industrial Property 

Information and Documentation, 

Standard ST.26: Recommended 

Standard for the Presentation of 

Nucleotide and Amino Acid Sequence 

Listings Using XML (eXtensible Markup 

Language) including Annexes I–VII, 

version 1.5, approved November 5, 

2021; IBR approved for §§ 1.831 through 

1.834. 

(2) [Reserved] 

Katherine K. Vidal, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office. 

[FR Doc. 2022–10343 Filed 5–19–22; 8:45 am] 

BILLING CODE 3510–16–P 

POSTAL SERVICE 

39 CFR Part 241 

Post Office Organization and 

Administration: Discontinuance of 

USPS-Operated Retail Facilities 

Correction 

■ In rule document 2022–10283, 

appearing on page 29673 in the issue of 

Monday, May 16, 2022, make the 

following correction: 

§ 241.3 Discontinuance of USPS-operated 

retail facilities. [corrected] 

On page 29673, in the second column, 

in the second instruction, on the second 

and third lines, ‘‘(b)(2) and (d)(3) 

introductory text’’ should read, ‘‘(b)(2) 

introductory text and (d)(3) introductory 

text’’. 

[FR Doc. C1–2022–10283 Filed 5–19–22; 8:45 am] 

BILLING CODE 0099–10–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Parts 52 and 81 

[EPA–R05–OAR–2020–0743; EPA–R05– 

OAR–2021–0886; EPA–R05–OAR–2022– 

0123; FRL–9567–01–R5] 

Air Plan Approval; Indiana; 

Redesignation of the Indiana Portion of 

the Chicago-Naperville Area to 

Attainment of the 2008 Ozone 

Standard, NOX RACT Waiver, and 

Serious Plan Elements 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Final rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) finds that the Indiana 

portion of the Chicago-Naperville, IL– 

IN–WI area (Chicago area) is attaining 

the 2008 ozone National Ambient Air 

Quality Standard (NAAQS or standard). 

In addition, in response to a December 

6, 2021, request from the Indiana 

Department of Environmental 

Management (Indiana or the State), EPA 

is redesignating the Indiana portion of 

the Chicago area to attainment for the 

2008 ozone NAAQS, because the State 

has met the statutory requirements for 

redesignation under the Clean Air Act 

(CAA). EPA is approving, as a revision 

to the Indiana State Implementation 

Plan (SIP), the State’s plan for 

maintaining the 2008 ozone NAAQS 

through 2035 for the Indiana portion of 

the Chicago area. EPA is also approving 

a waiver, for the Indiana portion of the 

Chicago area, from the oxides of 

nitrogen (NOX) requirements of the 

CAA. EPA finds adequate and is 

approving Indiana’s 2030 and 2035 

volatile organic compound (VOC) and 

NOX motor vehicle emission budgets 

(budgets) for the Indiana portion of the 

Chicago area. Finally, EPA is approving 

the VOC reasonably available control 

technology (RACT), clean-fuel vehicle 

programs (CFVP), enhanced monitoring 

of ozone and ozone precursors (EMP), 

and enhanced motor vehicle Inspection/ 

Maintenance (I/M) SIP revisions. These 

SIP revisions satisfy the above 

requirements for a nonattainment area 

that is classified as a ‘‘Serious area’’ for 

the Indiana portion of the Chicago area 

under the 2008 ozone NAAQS. EPA 

proposed to approve this action on 

March 3, 2022, and received adverse 

comments from one commentor. 

DATES: This final rule is effective on 

May 20, 2022. 

ADDRESSES: EPA has established dockets 

for this action under Docket ID No. 

EPA–R05–OAR–2020–0743 (regarding 

the serious area elements), EPA–R05– 


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