MPEP § 2416 — MPEP § 2416
Current through: 2022-07-01

2416-Form Paragraphs 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2400 

 Section 2416 
 

 
 
 
 
 
 2416 Form Paragraphs [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) .] 

 ¶ 24.17.26 Heading for ST.26 Sequence Requirements

 Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That
 Have Sequence Disclosures 

 37 CFR 1.831(a) requires that patent
 applications which contain disclosures of nucleotide and/or amino acid sequences that fall
 within the definitions of 37 CFR 1.831(b) must contain a
 "Sequence Listing XML", as a separate part of the disclosure, which
 presents the nucleotide and/or amino acid sequences and associated information using the
 symbols and format in accordance with the requirements of 37 CFR
 1.831 - 1.835 . This "Sequence Listing XML" part
 of the disclosure may be submitted: 
 

 
 1. In accordance with 37 CFR
 1.831(a) using the symbols and format requirements of
 37 CFR 1.832 
 through 1.834 via
 the USPTO patent electronic filing system (see Section I.1 of the Legal Framework
 for Patent Electronic System ( https://
 www.uspto.gov/PatentLegalFramework ), hereinafter "Legal
 Framework") in XML format, together with an incorporation by reference statement of
 the material in the XML file in a separate paragraph of the specification (an
 incorporation by reference paragraph) as required by 37 CFR
 1.835(a)(2) or 1.835(b)(2) identifying: 
 
 a. the name of the XML file 

 b. the date of creation; and 

 c. the size of the XML file in bytes; or 

 
 

 2. In accordance with 37 CFR
 1.831(a) using the symbols and format requirements of
 37
 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by
 37 CFR
 1.52(e)(1)(ii) , labeled according to 37 CFR
 1.52(e)(5) , with an incorporation by reference statement of
 the material in the XML format according to 37 CFR
 1.52(e)(8) and 37 CFR
 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification
 identifying: 
 
 a. the name of the XML file; 

 b. the date of creation; and 

 c. the size of the XML file in bytes. 

 
 SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE
 TO THIS NOTICE ARE AS FOLLOWS: 

 

 
 Examiner Note:
 
 1. This form paragraph should only be used where
 compliance with 37 CFR 1.831 - 1.835 is not required for examination of the application, or
 where a lack of compliance with 37 CFR 1.831 - 1.835 arose during prosecution. 
 

 2. This form paragraph must be followed by one or more of
 form paragraphs 24.18.26 -
 24.29.26 . 
 
 
 

 ¶ 24.18.26 No “Sequence Listing XML” part of the
 disclosure
 

 Specific deficiency - This application fails to
 comply with the requirements of 37 CFR 1.831 - 1.834 
 because it does not contain a "Sequence Listing XML" as a separate part of the disclosure. A
 “Sequence Listing XML” is required because <1>. 
 

 Required response - Applicant must provide:
 

 
 • A "Sequence Listing XML" part of the disclosure, as
 described above in item 1. or 2.; together with 
 o A statement that indicates the basis
 for the amendment, with specific references to particular parts
 of the application as originally filed, as required by 37 CFR
 1.835(a)(3) ; 
 

 o A statement that the "Sequence Listing XML"
 includes no new matter as required by 37 CFR
 1.835(a)(4) 

 
 

 AND

 • A substitute specification in compliance with
 37 CFR
 1.52 , 1.121(b)(3) , and 1.125 
 inserting the required incorporation by reference paragraph as required by
 37
 CFR 1.835(a)(2) , consisting of:
 
  A copy of the previously-submitted
 specification, with deletions shown with strikethrough or brackets and
 insertions shown with underlining (marked-up version); 
 

  A copy of the amended specification without
 markings (clean version); and 
 

  A statement that the substitute
 specification contains no new matter. 
 

 
 

 
 Examiner Note:
 
 1. This form paragraph should only be used where
 compliance with 37 CFR 1.831 - 1.835 is not required for examination of the application, or
 where a lack of compliance with 37 CFR 1.831 - 1.835 arose during prosecution. 
 

 2. This form paragraph must be preceded by form paragraph
 24.17.26. 
 

 3. This form paragraph should be used for an application
 that has no "Sequence Listing XML" in compliance with 37 CFR
 1.831 - 1.834 . The examiner should
 explain why a “Sequence Listing XML” is required in <1>. 
 

 4. This form paragraph may be followed by one or more
 deficiency form paragraphs. 
 
 
 

 ¶ 24.19.26 Defective “Sequence Listing XML”

 Specific deficiency - This application fails to
 comply with the requirements of 37 CFR 1.831 - 1.834 
 because the "Sequence Listing XML," as a separate part of the disclosure, is defective,
 damaged or unreadable. Refer to document "Sequence Listing in Computer Readable Format is
 Defective " dated [1] . 
 

 Required response - Applicant must provide: 
 

 
 • A replacement "Sequence Listing XML" part of the
 disclosure, as described above submitted in accordance with either item 1. or 2.;
 together with 
 
 o A statement that identifies the location of
 all additions, deletions or replacements of sequence information relative to
 the replaced “Sequence Listing XML” as required by 37 CFR
 1.835(b)(3) ; 
 

 o A statement that indicates support for the
 replacement “Sequence Listing XML” in the application, as filed, as required
 by 37 CFR 1.835(b)(4) ; and
 
 

 o A statement that the replacement "Sequence
 Listing XML" includes no new matter as required by 37 CFR
 1.835(b)(5) . 
 

 
 

 AND 

 • A substitute specification in compliance with
 37 CFR
 1.52 , 1.121(b)(3) , and 1.125 ,
 inserting the required incorporation-by-reference paragraph as required by
 37 CFR
 1.835(b)(2) , consisting of: 
 
 o A copy of the previously-submitted
 specification, with deletions shown with strikethrough or brackets and
 insertions shown with underlining (marked-up version); 
 

 o A copy of the amended specification without
 markings (clean version); and 
 

 o A statement that the substitute
 specification contains no new matter.
 

 
 

 
 Examiner Note:
 
 1 This form paragraph should only be used where
 compliance with 37 CFR 1.831 - 1.835 is not required for examination of the application, or
 where a lack of compliance with 37 CFR 1.831 - 1.835 arose during prosecution.
 

 2 This form paragraph must be preceded by form paragraph
 24.17.26. 
 

 3 This form paragraph should be used for an application
 where a defective "Sequence Listing XML" was filed and a notice was sent to the
 applicant including the errors identified according to STIC.
 

 4 This form paragraph may be followed by one or more
 deficiency form paragraphs.
 

 5 This form paragraph would only be used when an
 applicant provides a disc of a “Sequence Listing XML” in reply to an examiner
 requirement for a “Sequence Listing XML.” 
 
 
 

 ¶ 24.20.26 “Sequence Listing XML” contains errors according to
 STIC report 
 

 The “Sequence Listing XML” part of the disclosure filed with
 this application in accordance with 37 CFR 1.831 - 1.834 has
 been found to contain an error or errors as indicated on the document "Computer Readable
 Form (CRF) for Sequence Listing - Defective" dated [1] . Applicant must provide: 
 

 
 • A replacement "Sequence Listing XML" part of the
 disclosure, as described above submitted in accordance with either item 1. or 2.,
 together with 
 
 o A statement that identifies the location of
 all additions, deletions, or replacements of sequence information in the
 replacement “Sequence Listing XML” as required by 37 CFR
 1.835(b)(3) ; 
 

 o A statement that indicates support for the
 amendment in the application, as filed, as required by 37 CFR
 1.835(b)(4) ; 
 

 o A statement that the replacement "Sequence
 Listing XML" includes no new matter as required by 37 CFR
 1.835(b)(5) ; and 
 

 o A substitute specification in compliance
 with 37
 CFR 1.52 , 1.121(b)(3) , and 1.125 
 inserting the required incorporation by reference paragraph as required by
 37 CFR
 1.835(b)(2) , consisting of: 
 
  A copy of the previously-submitted
 specification, with deletions shown with strikethrough or brackets
 and insertions shown with underlining (marked-up version); 
 

  A copy of the amended specification
 without markings (clean version); and 
 

  A statement that the substitute
 specification contains no new matter. 
 

 
 

 
 

 
 Examiner Note:
 
 1. This form paragraph should only be used where
 compliance with 37 CFR 1.831 - 1.835 is not required for examination of the application, or
 where a lack of compliance with 37 CFR 1.831 - 1.835 arose during prosecution. 
 

 2. This form paragraph must be preceded by form paragraph
 24.17.26. 
 

 3. This form paragraph should be used for an application
 where a defective "Sequence Listing XML" was filed and a notice was sent to the
 applicant including the errors according to STIC. 
 

 4. This form paragraph may be followed by one or more
 deficiency form paragraphs. 
 
 
 

 ¶ 24.21.26 Sequence IDs not present in specification

 Specific deficiency - Sequences appearing in the
 specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like)
 in accordance with 37 CFR 1.831(c) . 
 

 Required response – Applicant must provide: A
 substitute specification in compliance with 37 CFR 1.52 , 1.121(b)(3) , and
 1.125 inserting the required sequence identifiers, consisting
 of:
 

 
 • A copy of the previously-submitted specification,
 with deletions shown with strikethrough or brackets and insertions shown with
 underlining (marked-up version); 
 

 • A copy of the amended specification without markings
 (clean version); and 
 

 • A statement that the substitute specification
 contains no new matter. 
 

 
 Examiner Note:
 
 1. This form paragraph should only be used where
 compliance with 37 CFR 1.831 - 1.835 is not required for examination of the application, or
 where a lack of compliance with 37 CFR 1.831 - 1.835 arose during prosecution. 
 

 2. This form paragraph must be preceded by form paragraph
 24.17.26. 
 

 3. This form paragraph should be used for an application
 where a sequence is embedded in the text of the description or claims of the patent
 application and reference has not also been 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. 
 

 4. This form paragraph may be followed by one or more
 deficiency form paragraphs. 
 
 
 

 ¶ 24.22.26 Sequence IDs not present in drawings

 Specific deficiency - Sequences appearing in the
 drawings are not identified by sequence identifiers in accordance with 37 CFR
 1.831(c) . Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or
 the like) must appear either in the drawings or in the Brief Description of the Drawings. 
 

 Required response – Applicant must provide: 
 

 Amended drawings in accordance with 37 CFR 1.121(d) 
 inserting the required sequence identifiers; 
 

 AND/OR 

 A substitute specification in compliance with 37 CFR 1.52 ,
 1.121(b)(3) , and 1.125 inserting the required sequence identifiers
 (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, consisting
 of:
 

 
 • A copy of the previously-submitted specification, with
 deletions shown with strikethrough or brackets and insertions shown with underlining
 (marked-up version); 
 

 • A copy of the amended specification without markings
 (clean version); and 
 

 • A statement that the substitute specification contains no
 new matter. 
 

 
 Examiner Note:
 
 1. This form paragraph should only be used where compliance with
 37
 CFR 1.831 - 1.835 is not required for
 examination of the application, or where a lack of compliance with 37 CFR
 1.831 - 1.835 arose during prosecution.
 
 

 2. This form paragraph must be preceded by form paragraph
 24.17.26 . 
 

 3. This form paragraph should be used for an application where
 a sequence is embedded in the text of the drawings and reference has not also been
 made to the sequence by use of the sequence identifier, preceded by "SEQ ID NO:X" or
 the like, in either the text of the drawings or the Brief Description or the
 Drawings. 
 

 4. This form paragraph may be followed by one or more deficiency
 form paragraphs. 
 
 
 

 ¶ 24.23.26 Sequence in specification, drawings, or claims that is not
 in XML
 

 This application contains sequence disclosures in accordance with
 the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR
 1.831(a) and 1.831(b) . However, this application
 fails to comply with the requirements of 37 CFR 1.831 - 1.834 . The
 examiner has noted that [1] . Applicant must provide:
 

 
 • A replacement "Sequence Listing XML" part of the
 disclosure, as described above in item 1. or 2., as well as 
 

 • A statement that identifies the location of all additions,
 deletions, or replacements of sequence information in the “Sequence Listing XML” as
 required by 37 CFR 1.835(b)(3) ; 
 

 • A statement that indicates support for the amendment in
 the application, as filed, as required by 37 CFR
 1.835(b)(4) ; 
 

 • A statement that the "Sequence Listing XML" includes no
 new matter in accordance with 37 CFR 1.835(b)(5) ; and 
 

 • A substitute specification in compliance with
 37 CFR
 1.52 , 1.121(b)(3) , and 1.125 
 inserting the required incorporation by reference paragraph as required by
 37 CFR
 1.835(b)(2) , consisting of:
 
 o A copy of the previously-submitted specification,
 with deletions shown with strikethrough or brackets and insertions shown
 with underlining (marked-up version); 
 

 o A copy of the amended specification without
 markings (clean version); and 
 

 o A statement that the substitute specification
 contains no new matter. 
 

 
 

 
 Examiner Note:
 
 1. This form paragraph should only be used where compliance
 with 37
 CFR 1.831 - 1.835 is not required for
 examination of the application, or where a lack of compliance with 37 CFR
 1.831 - 1.835 arose during prosecution.
 
 

 2. This form paragraph must be preceded by form paragraph
 24.17.26 . 
 

 3. Examiner needs to identify the sequences missing from the
 “Sequence Listing XML” that were found in the claims, drawing or specification in
 <1>. 
 

 4. This form paragraph may be followed by one or more
 deficiency form paragraphs. 
 
 
 

 ¶ 24.24.26 Missing, Defective, or Incomplete Incorporation by
 Reference Paragraph
 

 Specific deficiency - The incorporation by reference
 paragraph required by 37 CFR 1.834(c)(1) , 37 CFR
 1.835(a)(2) , or 1.835(b)(2) is missing, defective or
 incomplete. 
 

 Required response - Applicant must:
 

 
 • Provide a substitute specification in compliance with
 37 CFR
 1.52 , 1.121(b)(3) , and 1.125 
 inserting the required incorporation by reference paragraph, consisting of: 
 
 • A copy of the previously-submitted specification,
 with deletions shown with strikethrough or brackets and insertions shown
 with underlining (marked-up version); 
 

 • A copy of the amended specification without
 markings (clean version); and 
 

 • A statement that the substitute specification
 contains no new matter. 
 

 
 

 
 Examiner Note:
 
 1. This form paragraph should only be used where compliance
 with 37
 CFR 1.831 - 1.835 is not required for
 examination of the application, or where a lack of compliance with 37 CFR
 1.831 - 1.835 arose during prosecution.
 
 

 2. This form paragraph must be preceded by form paragraph
 24.17.26 . 
 

 3. This form paragraph should be used for an application where
 incorporation by reference paragraph is missing, defective or incomplete. The
 examiner should clearly specify how any defective incorporation by reference
 paragraphs is non-compliant, if applicable.
 

 4. The form paragraph maybe used when the incorporation by
 reference paragraphs provides erroneous information on the size of the sequence
 listing XML file, recites the size in kilobytes (KB) instead of bytes, and/or the
 file name for the sequence listing XML contains an error. 
 

 5. This form paragraph may be followed by one or more
 deficiency form paragraphs. 
 
 
 

 ¶ 24.25.26 Amendment Missing Statement of No New Matter 

 Specific deficiency - The "Sequence Listing XML" has
 not been entered into the application because the required statement of no new matter, in
 accordance with 37 CFR 1.835(a)(4) or 37 CFR
 1.835(b)(5) , is missing. 
 

 Required response - Applicant must submit a statement
 that the “Sequence Listing XML,” identified by the date the “Sequence Listing XML” was
 filed, includes no new matter. 
 

 Examiner Note:
 
 1. This form paragraph should only be used where a compliant
 “Sequence Listing XML” is not required for examination of the application.
 

 2. This form paragraph must be preceded by form paragraph
 24.17.26 . 
 

 3. This form paragraph should be used for an application where
 the statement of no new matter is missing. 
 

 4. This form paragraph may be followed by one or more deficiency
 form paragraphs. 
 
 
 

 ¶ 24.26.26 Amendment Missing Statement of Support

 Specific deficiency - The "Sequence Listing XML" has
 not been entered into the application because the required statement of support for the
 "Sequence Listing XML" in the application as filed, in accordance with 37 CFR
 1.835(a)(3) or 1.835(a)(4) , is missing. 
 

 Required response - Applicant must submit a proper
 statement that indicates the basis for the “Sequence Listing XML,” with specific references
 to particular parts of the application as originally filed (specification, claims, drawings)
 for added, deleted and/or modified sequence data. 
 

 Examiner Note:
 
 1. This form paragraph should only be used where compliance
 with 37
 CFR 1.831 - 1.835 is not required for
 examination of the application, or where a lack of compliance with 37 CFR
 1.831 - 1.835 arose during prosecution.
 
 

 2. This form paragraph must be preceded by form paragraph
 24.17.26 . 
 

 3. This form paragraph should be used for an application where
 the statement that indicates the basis for the “Sequence Listing XML” is missing.
 
 

 4. This form paragraph may be followed by one or more deficiency
 form paragraphs. 
 
 
 

 ¶ 24.27.26 “Sequence Listing XML” contains foreign language text 

 Specific deficiency - This application fails to comply
 with the requirements of 37 CFR 1.831 - 1.835 
 because the language-dependent free text elements within the "Sequence Listing XML" are not
 in the English language, as required by 37 CFR 1.833(b)(3) .
 

 Required response - As required by 37 CFR
 1.835(d)(2) , applicant must provide a translated "Sequence Listing
 XML" part of the disclosure in compliance with 37 CFR
 1.831 - 1.834 . 
 

 Examiner Note:
 
 1. This form paragraph should only be used where compliance
 with 37
 CFR 1.831 - 1.835 is not required for
 examination of the application, or where a lack of compliance with 37 CFR
 1.831 - 1.835 arose during prosecution.
 
 

 2. This form paragraph must be preceded by form paragraph
 24.17.26 . 
 

 3. This form paragraph should be used for an application where
 the “Sequence Listing XML” contains foreign text in the language-dependent free text
 elements. 
 

 4. This form paragraph may be followed by one or more
 deficiency form paragraphs. 
 
 
 

 ¶ 24.28.26 “Sequence Listing XML” bibliographic information does not
 match application
 

 Specific deficiency - The “Sequence Listing XML”
 submitted in the present application does not appear to be the correct sequence listing
 file. One or more of the following identifying information: invention title, applicant file
 reference, applicant name, inventor name, or earliest priority application do not match
 those in the official application. 
 

 Required response - Applicant must provide: 
 

 
 • A replacement "Sequence Listing XML" part of the
 disclosure, as described above in item 1. or 2., as well as 
 
 o A statement that identifies the location of all
 additions, deletions, or replacements of sequence information in the
 replacement “Sequence Listing XML” as required by 37 CFR
 1.835(b)(3) ; 
 

 o A statement that indicates support for the
 amendment in the application, as filed, as required by 37 CFR
 1.835(b)(4) , 
 

 o A statement that the replacement "Sequence Listing
 XML" includes no new matter in accordance with 37 CFR
 1.835(b)(5) , and 
 

 o A substitute specification in compliance with
 37 CFR
 1.52 , 1.121(b)(3) , and 1.125 
 inserting the required incorporation by reference paragraph as required by
 37 CFR
 1.835(b)(2) , consisting of: 
 
  A copy of the previously-submitted
 specification, with deletions shown with strikethrough or brackets
 and insertions shown with underlining (marked-up version); 
 

  A copy of the amended specification
 without markings (clean version); and 
 

  A statement that the substitute
 specification contains no new matter. 
 

 
 

 
 

 
 Examiner Note:
 
 1. This form paragraph should only be used where compliance
 with 37
 CFR 1.831 - 1.835 is not required for
 examination of the application, or where a lack of compliance with 37 CFR
 1.831 - 1.835 arose during prosecution.
 
 

 2. This form paragraph must be preceded by form paragraph
 24.17.26 . 
 

 3. This form paragraph should be used for an application where
 there is a discrepancy between the “Sequence Listing XML” bibliographic information
 and the application information in an application filed under 35 U.S.C.
 111(a) , if the application is a national stage, then the
 examiner should contact IPLA. 
 

 4. This form paragraph may be followed by one or more deficiency
 form paragraphs. 
 
 
 

 ¶ 24.29.26 Amendment Missing Statement of Location of Additions,
 Deletions or Replacements of Sequence Information
 

 Specific deficiency - The "Sequence Listing XML" has
 not been entered into the application because the required statement that identifies the
 location of all additions, deletions or replacements of the sequence information relative to
 the replaced “Sequence Listing XML” is missing. See 37 CFR
 1.835(b)(3) . 
 

 Required response - Applicant must provide a proper
 statement identifying all changes in the replacement “Sequence Listing XML” relative to the
 replaced sequence data.
 

 Examiner Note:
 
 1. This form paragraph should only be used where compliance with
 37
 CFR 1.831 - 1.835 is not required for
 examination of the application, or where a lack of compliance with 37 CFR
 1.831 - 1.835 arose during prosecution.
 
 

 2. This form paragraph must be preceded by form paragraph
 24.17.26 . 
 

 3. This form paragraph should be used for an application where
 the replacement “Sequence Listing XML” is not accompanied by a statement that
 indicates the location of all additions, deletions or replacements in the sequence
 information. 
 

 4. This form paragraph may be followed by one or more deficiency
 form paragraphs. 
 
 
 

 [top] 

 

 

 
 

 
 

 

 

 

 
 
 
 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