MPEP § 2415 — MPEP § 2415
Current through: 2022-07-01

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
 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2400 

 Section 2415 
 

 
 
 
 
 
 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 [R-01.2024]
 

 [Editor Note: This section is applicable to all applications with a filing date,
 or, for national phase applications, an international filing date, on or after July 1,
 2022, having disclosure of one or more nucleotide and/or amino acid sequences as defined
 in 37 CFR
 1.831(b) .] 

 Patent applications that contain disclosures of nucleotide
 and/or amino acid sequences must present the sequences and associated biological sequence
 data in a standardized electronic format. For those applications having a filing date on or
 after July 1, 2022, a “Sequence Listing XML” (see 37 CFR
 1.831(a) ) as a separate part of the specification is required. Note
 that for national phase applications submitted under 35 U.S.C. 371 , the relevant date is the
 international filing date.
 

 
 2415.01 Determining if a “Sequence Listing XML” Must be
 Submitted [R-01.2024]
 

 [Editor Note: This section is applicable to all applications with a filing
 date, or, for national phase applications, an international filing date, on or after
 July 1, 2022, having disclosure of one or more nucleotide and/or amino acid sequences
 as defined in 37 CFR 1.831(b) .] 

 An application filed under 35 U.S.C. 111(a) that has a
 filing date on or after July 1, 2022, or an application which entered the national
 stage, having an international 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 filing date or international filing date on or after July 1, 2022, that claim
 benefit or priority to applications with filing dates before July 1, 2022. Such
 applications include, but are not limited to, applications having one or more benefit or
 priority claims under 35 U.S.C. 119(e) (claiming the benefit of a provisional),
 35 U.S.C.
 120 (claiming the benefit as a continuation and/or
 continuation-in-part), 37 CFR 1.121 (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 transform that “Sequence Listing” into 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. See also MPEP § 1893.03(b) . 
 

 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 37 CFR 1.831 - 1.835 .
 

 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 WIPO Standard
 ST.25) or 37
 CFR 1.831 through 1.835 (rules based on WIPO Standard
 ST.26) simplifies the application of the sequence rules, both for the USPTO and the
 applicant. Though 37 CFR 1.821 through
 1.825 remain applicable for applications with a filing date
 before July 1, 2022, those provisions will not be applicable to applications filed on or
 after July 1, 2022.
 

 

 
 2415.02 Provisional Applications Containing Disclosures
 of Nucleotides and/or Amino Acids, Compliance with 37 CFR 1.831-1.834 [R-01.2024]
 

 [Editor Note: This section is applicable to all applications with a filing
 date, or, for national phase applications, an international filing date, on or after
 July 1, 2022, having disclosure of one or more nucleotide and/or amino acid sequences
 as defined in 37 CFR 1.831(b) .] 

 
 37 CFR 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 .
 

 
 *****

 

 
 

 Similar to the rules of practice regarding provisional
 applications filed before July 1, 2022, that contain disclosures of nucleotide and/or
 amino acid sequences, provisional applications filed on or after July 1, 2022, are not
 required to contain a separate compliant sequence listing. However, if an applicant
 chooses to file a separate sequence listing in an application filed on or after July 1,
 2022, the submission must be by way of a “Sequence Listing XML” that is compliant with
 37 CFR
 1.831 - 1.834 . Provisional applications
 cannot be amended, so if a provisional application contains a non-compliant “Sequence
 Listing XML” no notice relating to the requirements will be mailed in the
 application.
 

 

 
 2415.03 Improper Submissions of “Sequence Listing”
 under 1.821(c) When a “Sequence Listing XML” was Required [R-01.2024]
 

 [Editor Note: This section is applicable to all applications with a filing
 date, or, for national phase applications, an international filing date, on or after
 July 1, 2022, having disclosure of one or more nucleotide and/or amino acid sequences
 as defined in 37 CFR 1.831(b) .] 

 While implementing regulations and procedures for WIPO
 Standard ST.26, the USPTO recognized that an applicant might erroneously provide a
 “Sequence Listing” in ASCII plain text file format even though a “Sequence Listing XML”
 is required. Therefore, in the rare circumstance in which a “Sequence Listing” .txt file
 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 MPEP §
 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 file, or 37 CFR
 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 file, 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” erroneously submitted as an ASCII plain text file that is relied on for
 submission of a compliant “Sequence Listing XML,” (i.e., identifying the nucleotide
 and/or amino acid sequence information found in the “Sequence Listing XML” within the
 erroneously submitted ASCII “Sequence Listing”) 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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 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