MPEP § 2426 — MPEP § 2426
Current through: 2022-07-01

2426-Amendments to Add or Replace a “Sequence Listing” and CRF Copy Thereof Subject to WIPO ST. 25 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2400 

 Section 2426 
 

 
 
 
 
 
 2426 Amendments to Add or Replace a “Sequence Listing” and CRF Copy
 Thereof Subject to WIPO ST. 25 [R-07.2022]
 

 [Editor Note: This section is not applicable to 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) . See MPEP §§
 2412 - 2419 for guidance on WIPO ST.26
 requirements for applications filed on or after July 1, 2022.] 

 
 37 CFR 1.825 Amendments to add or replace a “Sequence Listing” and CRF copy
 thereof. 

 
 (a) Any amendment adding a “Sequence Listing” (§ 1.821(c) )
 after the application filing date must include:
 
 (1) A “Sequence Listing,” in accordance with the
 requirements of §§ 1.821 through 1.824 ,
 submitted as:
 
 (i) An ASCII plain text file, under §
 1.821(c)(1) , via
 the USPTO patent electronic filing system or on a read-only optical
 disc, in compliance with § 1.52(e) ; 
 

 (ii) A PDF file via the USPTO patent
 electronic filing system; or 
 

 (iii) Physical sheets of paper;

 
 

 (2) A request that the amendment be made: 
 
 (i) By incorporation by reference of the
 material in the ASCII plain text file, in a separate paragraph of the
 specification, identifying the name of the file, the date of creation,
 and the size of the file in bytes ( see §
 1.77(b)(5) ), for a “Sequence Listing” submitted
 under § 1.821(c)(1) ,
 except when submitted to the United States International Preliminary
 Examining Authority for an international application; or
 

 (ii) By inserting, after the abstract of
 the disclosure, a “Sequence Listing” submitted as a PDF file under §
 1.821(c)(2) or
 submitted on physical sheets of paper under § 1.821(c)(3) , 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
 (specification, claims, drawings) for all sequence data in the “Sequence
 Listing” in the application as originally filed; 
 

 (4) A statement that the “Sequence Listing”
 includes no new matter; 
 

 (5) A new or substitute CRF under §
 1.821(e) , if: 
 
 (i) (The added “Sequence Listing” is
 submitted as a PDF file, under § 1.821(c)(2) , or on physical sheets of paper,
 under § 1.821(c)(3) ; and
 
 

 (ii) A CRF, under § 1.821(e) , was not submitted, not compliant with
 § 1.824 , or not the same as the “Sequence
 Listing”; and 
 

 
 

 (6) A statement that the sequence information
 contained in the CRF is the same as the sequence information contained in
 the added “Sequence Listing,” if submitted as a PDF file, under §
 1.821(c)(2) , or on
 physical sheets of paper, under § 1.821(c)(3) . 
 

 
 

 (b) Any amendment to a “Sequence Listing” (§ 1.821(c) )
 must include:
 
 (1) A replacement “Sequence Listing,” in
 accordance with the requirements of §§ 1.821 
 through 1.824 , submitted as:
 
 (i) An ASCII plain text file, under §
 1.821(c)(1) , via
 the USPTO patent electronic filing system, or 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); 
 

 (ii) A PDF file via the USPTO patent
 electronic filing system; or 
 

 (iii) Physical sheets of paper; 

 
 

 (2) A request that the amendment be made:
 
 (i) By incorporation by reference of the
 material in the ASCII plain text file, in a separate paragraph of the
 specification (replacing any prior such paragraph, as applicable)
 identifying the name of the file, the date of creation, and the size
 of the file in bytes (see § 1.77(b)(5) ) for a “Sequence Listing” under §
 1.821(c)(1) ,
 except when submitted to the United States International Preliminary
 Examining Authority for an international application; or
 

 (ii) By placing, after the abstract of the
 disclosure, a “Sequence Listing” submitted as a PDF file, under §
 1.821(c)(2) , or on
 physical sheets of paper, under § 1.821(c)(3) (replacing any prior “Sequence
 Listing,” as applicable), except when submitted to the United States
 International Preliminary Examining Authority for an international
 application; 
 

 
 

 (3) A statement that identifies the location of
 all deletions, replacements, or additions to the “Sequence Listing”; 
 

 (4) A statement that indicates the basis for the
 amendment, with specific references to particular parts of the application
 (specification, claims, drawings) as originally filed for all amended
 sequence data in the replacement “Sequence Listing”; 
 

 (5) A statement that the replacement “Sequence
 Listing” includes no new matter;
 

 (6) A new or substitute CRF, under §
 1.821(e) , with the amendment incorporated therein,
 if: 
 
 (i) The replacement “Sequence Listing” is
 submitted as a PDF file, under § 1.821(c)(2) , or on physical sheets of paper,
 under § 1.821(c)(3) ; and
 
 

 (ii) A CRF, under § 1.821(e) , was not submitted, not compliant with
 § 1.824 , or not the same as the submitted
 “Sequence Listing”; and
 

 
 

 (7) A statement that the sequence information
 contained in the CRF is the same as the sequence information contained in
 the replacement “Sequence Listing” when submitted as a PDF file, under §
 1.821(c)(2) , or on
 physical sheets of paper, under § 1.821(c)(3) .
 

 
 

 (c) The specification of a complete application, filed on the
 application filing date, with a “Sequence Listing” as an ASCII plain text file,
 under § 1.821(c)(1) , without an
 incorporation by reference of the material contained in the ASCII plain text file,
 must be amended to contain a separate paragraph incorporating by reference the
 material contained in the ASCII plain text file, in accordance with §
 1.77(b)(5) , except for international applications during
 the international stage or national stage.
 

 (d) Any appropriate amendments to the “Sequence Listing” in a patent
 ( e.g., by reason of reissue, reexamination, or a certificate
 of correction) must comply with the requirements of paragraph (b) of this
 section.
 

 
 

 37 CFR
 1.825 sets forth the procedures for adding or replacing the “Sequence
 Listing” and the CRF thereof. Under 37 CFR 1.825(a) , adding a “Sequence
 Listing” after the application filing date involves the submission of: (1) a “Sequence
 Listing” either as a PDF image file, on physical sheets of paper, or as an ASCII plain text
 file submitted via the USPTO patent electronic filing system or on read-only optical
 disc(s), (2) a request that the amendment be made by either incorporation by reference in
 the case of ASCII plain text files or inserting text into the specification in the case of
 PDF image files or physical sheets of paper, (3) a statement that indicate the basis for
 the amendment in the application, as originally filed, (4) a statement that the “Sequence
 Listing” includes no new matter, (5) a new or substitute CRF when the submission is a PDF
 image file or on physical sheets of paper, and (6) a statement that the sequence
 information contained in the CRF is the same as the sequence information contained in the
 added “Sequence Listing” when the submission is a PDF image file or on physical sheets of
 paper. (See MPEP §
 2428 for further information and sample statements.) If the
 “Sequence Listing” is filed as an ASCII plain text file only, thereby serving both as a
 “Sequence Listing” under 37 CFR 1.821(c) and a CRF under 37 CFR 1.821(e) , then
 an incorporation by reference statement is required in the specification (replacing any
 prior such paragraph) (see 37 CFR 1.77(b)(5) ). If the “Sequence Listing” is
 filed as a PDF image file or on physical sheets of paper, then the “Sequence Listing” must
 be placed after the abstract of the disclosure. Also, if the added “Sequence Listing” is
 submitted as a PDF image file or on physical sheets of paper and a separate CRF under
 37 CFR
 1.821(e) was either not submitted, not compliant with
 37 CFR
 1.824 , or not the same as the submitted “Sequence Listing”, then a
 new or substitute separate CRF is required along with a statement that the sequence
 information contained in the CRF is the same as the sequence information contained in the
 added “Sequence Listing”. It is noted that an incorporation by reference statement should
 not be submitted for a separate CRF of a “Sequence Listing” submitted under
 37 CFR
 1.821(e) .
 

 Under 37 CFR 1.825(b) , amending the “Sequence
 Listing” involves the submission of a replacement “Sequence Listing” either as a PDF image
 file, on physical sheets of paper, or as an ASCII plain text file submitted via the USPTO
 patent electronic filing system or on read-only optical disc(s), in conjunction with
 statements that identify the location of all deletions, replacements, or additions to the
 “Sequence Listing”, indicate the basis for the amendment in the application, as originally
 filed, and that the replacement “Sequence Listing” includes no new matter. (See
 MPEP §
 2428 for further information and sample statements.) These
 statements may be made by a registered practitioner, the applicant, an inventor, or the
 person who actually compares the sequence data on behalf of the aforementioned. It is noted
 that any amendment to the information on a read-only optical disc must be by the way of a
 replacement read-only optical disc. 37 CFR 1.52(e)(7) . If the replacement
 “Sequence Listing” is filed as an ASCII plain text file, then an incorporation by reference
 statement is required in the specification (replacing any prior such paragraph) (see
 37 CFR
 1.77(b)(5) ). If the replacement “Sequence Listing” is filed as a PDF
 image file or on physical sheets of paper, then the replacement “Sequence Listing” must be
 placed after the abstract of the disclosure. Also, if the replacement “Sequence Listing” is
 submitted as a PDF image file or on physical sheets of paper and a separate CRF under
 37 CFR
 1.821(e) was either not submitted, not compliant with
 37 CFR
 1.824 , or not the same as the submitted “Sequence Listing”, then a
 new or substitute separate CRF is required along with a statement that the sequence
 information contained in the CRF is the same as the sequence information contained in the
 replacement “Sequence Listing”. It is noted that an incorporation by reference statement
 should not be submitted for a separate CRF of a “Sequence Listing” submitted under
 37 CFR
 1.821(e) . If the “Sequence Listing” required by 37 CFR 1.821(c) was
 filed on a read-only optical disc that included files in addition to the “Sequence
 Listing”, a replacement read-only optical disc containing the amended “Sequence Listing”
 also must contain all of the files of the original read-only optical disc that were not
 amended. This will ensure that the Office, printer, and public can quickly access all of
 the current files in an application or patent by referencing only the latest version. 
 

 The requirement for statements regarding the absence of new
 matter follows current practice relating to the submission of substitute specifications, as
 set forth in 37 CFR
 1.125 . 37 CFR 1.825(c) requires that the
 specification must be amended to contain an incorporation by reference statement of the
 material contained in a “Sequence Listing” ASCII plain text file if the “Sequence Listing”
 ASCII plain text file was filed on the application filing date without an incorporation by
 reference statement, except if the “Sequence Listing” ASCII plain text file was filed on
 the application filing date of an international application regardless of whether the
 international application is currently in the international stage or the national stage.
 37 CFR
 1.825(d) addresses the situation where amendments to the “Sequence
 Listing” are made after a patent has been granted, e.g., by a certificate of correction,
 reissue or reexamination, and states that such amendments must comply with the requirements
 of 37 CFR
 1.825(b) .
 

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 2401-Introduction 

 2402-The Deposit Rules 

 2403-Deposit of Biological Material 
 2403.01-Material Capable of Self- Replication 

 2403.02-Plant Material 

 
 

 2404-Need or Opportunity to Make a Deposit 
 2404.01-Biological Material That Is Known and Readily Available to the Public 

 2404.02-Biological Material That Can Be Made or Isolated Without Undue Experimentation 

 2404.03-Reference to a Deposit in the Specification 

 
 

 2405-Acceptable Depository 

 2406-Time of Making an Original Deposit 
 2406.01-Description in Application Specification 

 2406.02-Deposit After Filing Date - Corroboration 

 2406.03-Possible Loss of U.S. Filing Date in Other Countries 

 
 

 2407-Replacement or Supplement of Deposit 
 2407.01-In a Pending Application 

 2407.02-After a Patent Has Issued 

 2407.03-Failure to Replace 

 2407.04-Treatment of Replacement 

 2407.05-Exemption From Replacement 

 2407.06-Replacement May Not Be Recognized 

 
 

 2408-Term of Deposit 

 2409-Viability of Deposit 

 2410-Furnishing of Samples 
 2410.01-Conditions of Deposit 

 2410.02-Certification of Statement of Availability of Deposit 

 
 

 2411-Examination Procedures 
 2411.01-Rejections Based on Deposit Issue 

 2411.02-Replies to Rejections Based on Deposit Issue 

 2411.03-Application in Condition for Allowance Except for Deposit 

 2411.04-[Reserved] 

 2411.05-Content of Application with Respect to Deposited Material 

 
 

 2412-The Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures to Include
 a Sequence Listing in XML file format 
 2412.01-Overview of the Sequence Rules 

 2412.02-Definition of “Sequence Listing XML” 
 2412.02(a)-“Enumeration of its residues” 

 
 

 2412.03-Nucleotides and Amino Acids Included and Excluded From a “Sequence Listing XML” 
 2412.03(a)-“Specifically Defined” 

 2412.03(b)-“Amino Acid” 

 2412.03(c)-“Modified Amino Acid” 

 2412.03(d)-“Nucleotide” 

 2412.03(e)-“Modified Nucleotide” 

 
 

 2412.04-Use of Sequence Identifiers to Denote Sequences Disclosed in the Description, Drawings or Claims 

 2412.05-Representation and Symbols for Nucleotide and/or Amino Acid Sequences 
 2412.05(a)-Use of Sequentially Numbered Sequence Identifiers in the “Sequence Listing XML” 

 2412.05(b)-Representation and Symbols of Nucleotide Sequence Data 

 2412.05(c)-Representation and Inclusion of Variants 

 2412.05(d)-Representation and Symbols of Amino Acid Sequence Data 

 2412.05(e)-Presentation of Special Situations 

 
 

 2412.06-The Requirement for Exclusive Conformance; Sequences Presented in Drawing Figures 

 2412.07-Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences 

 
 

 2413-Content of a “Sequence Listing XML” and Form and Format of the “Sequence Listing XML” File 
 2413.01-Parts of the “Sequence Listing XML” 
 2413.01(a)-The “Sequence Listing XML” is a Single File Encoded Using Unicode UTF-8 

 2413.01(b)-The “Sequence Listing XML” Must Be Valid According To the DTD 

 2413.01(c)-The “Sequence Listing XML” Must Contain an XML Declaration 

 2413.01(d)-The “Sequence Listing XML” Must Contain a DOCTYPE Declaration 

 2413.01(e)-The “Sequence Listing XML” Must Contain a Root Element 

 2413.01(f)-The “Sequence Listing XML” Must Contain a General Information Part 

 2413.01(g)-The “Sequence Listing XML” Must Contain a Sequence Data Part 

 2413.01(h)-Language Dependent Free Text Qualifier Values in the English Language 

 2413.01(i)-Title Element in “Sequence Listing XML” 

 
 

 2413.02-Form and Format of the XML file containing the “Sequence Listing XML” 

 2413.03-How to Submit the “Sequence Listing XML” 

 2413.04-Requirements Regarding Incorporation By Reference of the “Sequence Listing XML” 

 2413.05-Presumptions Regarding Compliance 

 
 

 2414-Notification of a Failure to Comply with Sequence Listing Requirements and Amendments Relating to “Sequence Listing XML” Files
 Under 37 CFR 1.835 
 2414.01-Issuance of a Notice Relating to the Requirements For Patent Applications Containing Nucleotide and/or Amino Acid Sequence
 Disclosures 

 2414.02-Amendment to Add an Initial “Sequence Listing XML” under 37 CFR 1.835(a) 

 2414.03-Amendment Adding to, Deleting from, or Replacing Sequence Information in a “Sequence Listing XML” under 37 CFR 1.835(b) 

 2414.04-Translation of “Sequence Listing XML” is Not an Amended “Sequence Listing XML” under 37 CFR 1.835(b) 

 2414.05-Notifications for Failure to Submit a “Sequence Listing XML” in an International Application under the PCT to be Searched
 by the United States International Searching Authority or Examined by International Preliminary Examination Authority 

 2414.06-Amendment of a “Sequence Listing XML” in a Patent 

 
 

 2415-Applicability date of “Sequence Listing XML” Requirements to Applications Based on Filing Date of Application and Procedures
 for Failure to Submit Correct Format of Sequence Listing 
 2415.01-Determining if a “Sequence Listing XML” Must be Submitted 

 2415.02-Provisional Applications Containing Disclosures of Nucleotides and/or Amino Acids, Compliance with 37 CFR 1.831-1.834 

 2415.03-Improper Submissions of “Sequence Listing” under 1.821(c) When a “Sequence Listing XML” was Required 

 
 

 2416-Form Paragraphs 

 2417-Helpful Hints for Sequence Rules Compliance under WIPO Standard ST.26 

 2418-WIPO Sequence Tool 

 2419-Publishing of Patent Grants and Patent Application Publications with a “Sequence Listing XML” 
 2419.01-Patent Grants and Patent Application Publications Containing a Non-Lengthy “Sequence Listing XML” 

 2419.02-Patent Grants and Patent Application Publications Containing a Lengthy “Sequence Listing XML” 

 2419.03-Patent Grants and Patent Application Publications Containing a “Sequence Listing XML” of 1GB or Larger 

 
 

 2420-The Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures under World
 Intellectual Property Office Standard ST.25 (WIPO ST.25) - the Sequence Rules 

 2421-Overview of the Sequence Rules under WIPO ST.25 
 2421.01-Definition of “Sequence Listing” and Computer Readable Form (CRF) 

 2421.02-Summary of the Requirements of the Sequence Rules 

 2421.03-Notification of a Failure to Comply 

 2421.04-[Reserved] 

 
 

 2422-Nucleotide and/or Amino Acid Sequence Disclosures in Patent Applications Subject to WIPO ST.25 
 2422.01-Nucleotide and/or Amino Acids Disclosures Requiring a “Sequence Listing” 

 2422.02-The Requirement for Exclusive Conformance; Sequences Presented in Drawing Figures 

 2422.03-Sequence Listing Submission 

 2422.03(a)-“Sequence Listing” Submitted as ASCII Plain Text Files 

 2422.04-The Requirement for a Computer Readable Copy of the “Sequence Listing” 

 2422.05-[Reserved] 

 2422.06-Requirement for Statement Regarding Information Contained in the “Sequence Listing” and Separate Computer Readable Form 

 2422.07-Requirements for Compliance and Consequences of Non-Compliance 

 2422.08-Presumptions Regarding Compliance 

 2422.09-[Reserved] 

 
 

 2423-Symbols and Format To Be Used for Nucleotide and/or Amino Acid Sequence Data for WIPO ST.25 
 2423.01-Format and Symbols To Be Used in a “Sequence Listing” 

 2423.02-Depiction of Coding Regions 

 2423.03-Presentation and Numbering of Sequences 

 
 

 2424-Requirements for Content of a “Sequence Listing” Part of the Specification under WIPO ST.25. 
 2424.01-Informational Requirements for the “Sequence Listing” 

 2424.02-“Sequence Listing” Numeric Identifiers 

 2424.03-Additional Miscellaneous Requirements 

 
 

 2425-Form and Format for a Nucleotide and/or Amino Acid Sequence Submission as an ASCII Plain Text File under WIPO ST.25 

 2426-Amendments to Add or Replace a “Sequence Listing” and CRF Copy Thereof Subject to WIPO ST. 25 

 2427-Form Paragraphs for Applications Subject to WIPO ST.25 

 2428-Sample Statements under WIPO ST.25 

 2429-Helpful Hints for Sequence Rules Compliance under WIPO ST.25 

 2430-PatentIn Information 

 2431-Sample “Sequence Listing” under WIPO ST.25 

 2432-[Reserved] 

 2433-Box Sequence; Hand Delivery of a “Sequence Listing” and Computer Readable Forms 

 2434-Examination of Patent Applications Claiming Large Numbers of Nucleotide Sequences 

 2435-Publishing of Patents and Patent Application Publications with a Lengthy “Sequence Listing” 

 

 

 
 

 
 
 

 
 

 

 
 
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 Last Modified: 
 
 03/09/2026 20:50:46