MPEP § 2424 — MPEP § 2424
Current through: 2022-07-01

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

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Chapter 2400 

 Section 2424 
 

 
 
 
 
 
 2424 Requirements for Content of a “Sequence Listing” Part of the
 Specification under 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 1.823 Requirements for content of a “Sequence Listing” part of the
 specification. 

 
 (a) The “Sequence Listing” must comply with the
 following:
 
 (1) The order and presentation of the items of information in
 the “Sequence Listing” shall conform to the arrangement in appendix G to
 this subpart. The submission of those items of information designated with
 an “M” is mandatory. The submission of those items of information designated
 with an “O” is optional. 
 

 (2) Each item of information shall begin on a new line, with
 the numeric identifier enclosed in angle brackets, as shown in appendix G to
 this subpart. 
 

 (3) Set forth numeric identifiers <110>
 through <170> at the beginning of the “Sequence Listing.” 
 

 (4) Include each disclosed nucleotide and/or
 amino acid sequence, as defined in § 1.821(a) . 
 

 (5) Assign a separate sequence identifier to
 each sequence, beginning with 1 and increasing sequentially by integers, and
 include the sequence identifier in numeric identifier <210>.
 

 (6) Use the code “000” in place of the sequence
 where no sequence is present for a sequence identifier. 
 

 (7) Include the total number of SEQ ID NOs in
 numeric identifier <160> , as defined in appendix G to this subpart,
 whether followed by a sequence or by the code “000.”
 

 (8) Must not contain more than 74 characters per
 line.
 

 
 

 (b)
 
 (1) Unless paragraph (b)(2) of this section applies, if the
 “Sequence Listing” required by § 1.821(c) is submitted as an ASCII plain text file 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 ASCII plain text file identifying: 
 
 (i) The name of the file; 

 (ii) The date of creation; and

 (iii) The size of the file in bytes.

 
 

 (2) If the “Sequence Listing” required by §
 1.821(c) is submitted as an ASCII plain text file 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 incorporation by reference
 of the material in the ASCII plain text file is not required. 
 

 (3) A “Sequence Listing” required by §
 1.821(c) that is submitted as a PDF file (§
 1.821(c)(2) ) via the
 USPTO patent electronic filing system or on physical sheets of paper (§
 1.821(c)(3) ), setting
 forth the nucleotide and/or amino acid sequence and associated information
 in accordance with paragraph (a) of this section: 
 
 (i) Must begin on a new page;

 (ii) Must be titled “Sequence Listing”;

 (iii) Must not include material other than
 the “Sequence Listing” itself;
 

 (iv) Must have sheets containing no more
 than 66 lines, with each line containing no more than 74
 characters;
 

 (v) Should have sheets numbered
 independently of the numbering of the remainder of the application;
 and 
 

 (vi) Should use a fixed-width font
 exclusively throughout.
 

 
 

 
 

 
 

 
 Appendix G to Subpart G of Part 1 - Numeric
 Identifiers
 
 
 
 Numeric Identifier 
 Definition 
 Comments and format 
 Mandatory (M) or optional (O) 
 

 
 
 
 <110> 
 Applicant 
 If Applicant is inventor, then preferably max. of 10 names;
 one name per line; preferable format: Surname, Other Names and/or Initials. 
 
 M. 
 

 
 <120> 
 Title of Invention 
 
 M. 
 

 
 <130> 
 File Reference 
 Personal file reference 
 M when filed prior to assignment or appl. number. 
 

 
 <140> 
 Current Application Number 
 Specify as: US 09/999,999 or PCT/US09/99999 
 M, if available. 
 

 
 <141> 
 Current Filing Date 
 Specify as: yyyy-mm-dd 
 M, if available. 
 

 
 <150> 
 Prior Application Number 
 Specify as: US 09/999,999 or PCT/US09/99999 
 M, if applicable include priority documents under 35 U.S.C. 119
 and 120.
 
 

 
 <151> 
 Prior Application Filing Date 
 Specify as: yyyy-mm-dd 
 M, if applicable. 
 

 
 <160> 
 Number of SEQ ID NOs 
 Count includes total number of SEQ ID NOs 
 M. 
 

 
 <170> 
 Software 
 Name of software used to create the “Sequence Listing” 
 O. 
 

 
 <210> 
 SEQ ID NO:#: 
 Response shall be an integer representing the SEQ ID NO shown 
 M. 
 

 
 <211> 
 Length 
 Respond with an integer expressing the number of bases or amino
 acid residues 
 
 M. 
 

 
 <212> 
 Type 
 Whether presented sequence molecule is DNA, RNA, or PRT
 (protein). If a nucleotide sequence contains both DNA and RNA fragments, the
 type shall be “DNA.” In addition, the combined DNA/ RNA molecule shall be
 further described in the <220> to <223> feature section 
 
 M. 
 

 
 <213> 
 Organism 
 Scientific name, i.e., Genus/species,
 Unknown or Artificial Sequence. In addition, the “Unknown” or “Artificial
 Sequence” organisms shall be further described in the <220> to <223>
 feature section 
 
 M. 
 

 
 <220> 
 Feature 
 Leave blank after <220>. <221-223> provide for a
 description of points of biological significance in the sequence
 
 M, under the following conditions: If “n,” “Xaa,” or a modified
 or unusual L-amino acid or modified base was used in a sequence; if ORGANISM is
 “Artificial Sequence” or “Unknown”; if molecule is combined DNA/ RNA. 
 
 

 
 <221> 
 Name/Key 
 Provide appropriate identifier for feature, from WIPO Standard
 ST.25 (2009), Appendices E and F to this subpart
 
 M, under the following conditions: If “n,” “Xaa,” or a modified
 or unusual L-amino acid or modified base was used in a sequence.
 
 

 
 <222> 
 Location 
 Specify location within sequence; where appropriate, state
 number of first and last bases/amino acids in feature
 
 M, under the following conditions: If “n,” “Xaa,” or a modified
 or unusual L-amino acid or modified base was used in a sequence.
 
 

 
 <223> 
 Other Information. 
 Other relevant information; four lines maximum. 
 M, under the following conditions: If "n,” “Xaa,” or a modified
 or unusual L- amino acid or modified base was used in a sequence; if ORGANISM
 is “Artificial Sequence” or “Unknown”; if molecule is combined DNA/ RNA.
 
 
 

 
 <300> 
 Publication Information 
 Leave blank after <30>. 
 O. 
 

 
 <301> 
 Authors 
 Preferably max. of 10 named authors of publication; specify one
 name per line; preferable format: Surname, Other Names and/or Initials. 
 
 O. 
 

 
 <302> 
 Title 
 
 O. 
 

 
 <303> 
 Journal 
 
 O. 
 

 
 <304> 
 Volume 
 
 O. 
 

 
 <305> 
 Issue 
 
 O. 
 

 
 <306> 
 Pages 
 
 O. 
 

 
 <307> 
 Date 
 Journal date on which data published; specify as yyyy-mm-dd,
 MMM-yyyy or Season-yyyy 
 
 O. 
 

 
 <308> 
 Database Accession Number. 
 Accession number assigned by database, including database
 name
 
 O. 
 

 
 <309> 
 Database Entry Date. 
 Date of entry in database; specify as yyyy-mm-dd or MMM-yyyy 
 O. 
 

 
 <310> 
 Patent Document Number. 
 Document number; for patent-type citations only. Specify as,
 for example, US 09/ 999,999 
 
 O. 
 

 
 <311> 
 Patent Filing Date. 
 Document filing date, for patent-type citations only; specify
 as yyyy-mm-dd 
 
 O. 
 

 
 <312> 
 Publication Date. 
 Document publication date, for patent-type citations only;
 specify as yyyy-mm-dd 
 
 O. 
 

 
 <313> 
 Relevant Residues. 
 FROM (position) TO (position) 
 O. 
 

 
 <400> 
 Sequence 
 SEQ ID NO should follow the numeric identifier and should
 appear on the line preceding the actual sequence 
 
 M. 
 

 
 
 
 2424.01 Informational Requirements for the “Sequence Listing” [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
 1.823 sets forth the informational requirements for the content of
 a “Sequence Listing” part of the specification that must be submitted in accordance with
 37 CFR
 1.821(c) as part of the application. See MPEP § 2422.03 for a
 discussion of 37 CFR
 1.821(c) . 
 

 37 CFR
 1.823(a) sets forth the content requirements for a “Sequence
 Listing”. Such requirements include, but are not limited to, sequence identifiers, the
 order and presentation of items of information, mandatory and optional information, the
 format as to line spacing, and the use of numeric identifiers. 
 

 37 CFR
 1.823(b)(1) sets forth a requirement for applications, other than
 an international application in the international stage, to contain, in the
 specification of the patent application, an express incorporation by reference of the
 material submitted as an ASCII plain text file via the USPTO patent electronic filing
 system or on a read-only optical disc(s) identifying the name of the file, the date of
 creation, and the size of the file in bytes.
 

 37 CFR 1.823(b)(2) specifically
 exempts international applications during the international stage from the incorporation
 by reference requirement in 37 CFR 1.823(b)(1) . 
 

 37 CFR
 1.823(b)(3) sets forth the format and content for a “Sequence
 Listing” that is submitted either as a PDF image file via the USPTO patent electronic
 filing system or on physical sheets of paper, in accordance with 37 CFR
 1.823(b)(1)(i) - (vi) .
 

 

 
 2424.02 “Sequence Listing” Numeric Identifiers [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
 1.823(a) sets forth the order and presentation of the items of
 information in the “Sequence Listing”. Each item of information in the “Sequence
 Listing” must include the appropriate numeric identifier and its accompanying
 information as in Appendix G to Subpart G of Part 1. Each item of information must begin
 on a new line with the numeric identifier enclosed in angle brackets. The submission of
 those items of information designated with an “M” is mandatory. The submission of those
 items of information designated with an “O” is optional. Numeric identifiers <110>
 through <170> must be set forth at the beginning of the “Sequence Listing”.
 

 See MPEP § 2431 for a sample “Sequence Listing”.
 

 

 
 2424.03 Additional Miscellaneous Requirements [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.] 

 Throughout 37 CFR 1.823(a) , the items of
 information relating to patent applications and patent publications should be provided
 keeping in mind the appropriate standards that have been established by the World
 Intellectual Property Organization (WIPO). In general, an application should be
 identified by a country code, a number and a filing date, while a published patent
 document should be identified by a country code, a number and kind code. Proper citation
 of priority patent applications is covered in MPEP §
 214.04 . For published patent documents, the country code,
 number and kind code will appear on the front page of the document. Unpublished PCT
 applications are identified by the letters PCT, the country code of the Receiving
 Office, and the four digit year of filing and a six digit number, e.g.,
 PCT/SE2011/000123. A published PCT application is identified by the letters WO, the four
 digit year of publication and a six digit number, e.g. WO/2015/009167. Country codes
 from WIPO Standard ST.3 Annex A and kind codes from WIPO Standard ST.16 are accessible
 on WIPO’s website ( www.wipo.int/standards/en/part_03_standards.html ). See also
 MPEP §
 1851 . Questions on proper citation of patent documents should
 be directed to staff in the Office of International Patent Legal Administration.
 

 See Appendix G to Subpart G of Part 1 of the CFR
 (reproduced in MPEP §
 2424 ) for information regarding numeric identifiers.
 

 

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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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 03/09/2026 20:49:36