MPEP § 2414 — MPEP § 2414
Current through: 2022-07-01

2414-Notification of a Failure to Comply with Sequence Listing Requirements and Amendments Relating to “Sequence Listing XML” Files
 Under 37 CFR 1.835
 
 
 

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2400 

 Section 2414 
 

 
 
 
 
 
 2414 Notification of a Failure to Comply with Sequence
 Listing Requirements and Amendments Relating to “Sequence Listing XML” Files Under 37 CFR
 1.835 [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) .] 

 When an application filed under 35 U.S.C.
 111(a) having 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, contains disclosure of nucleotide and/or amino acid sequences, a
 “Sequence Listing XML” is required. When no “Sequence Listing XML” or a defective “Sequence
 Listing XML” is submitted in an application where a compliant “Sequence Listing XML” is
 required, the pre-examination staff will issue a notification that compliance with
 37 CFR
 1.831 - 1.835 is required and an added initial
 submission of a “Sequence Listing XML” ( 37 CFR 1.835(a) ) or replacement
 “Sequence Listing XML” ( 37 CFR 1.835(b) ) will be required.
 Additionally, the examiner can require the filing of a “Sequence Listing XML” if an
 application fails to comply with 37 CFR 1.831 - 1.834 . For
 example, if there are sequences in the disclosure which are not part of the “Sequence
 Listing XML” of record, then the examiner can require a replacement “Sequence Listing XML”
 which includes the omitted sequences. See form paragraphs 24.18.26 - 24.20.26, 24.23.26,
 and 24.27.26-24.28.26.
 

 
 2414.01 Issuance of a Notice Relating to the
 Requirements For Patent Applications Containing Nucleotide and/or Amino Acid Sequence
 Disclosures [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 1.835 Amendment to add or replace a “Sequence
 Listing XML” in patent applications filed on or after July 1, 2022. 

 
 
 *****

 

 
 
 (d)(1) If any of the requirements of §§ 1.831 through 1.834 are not satisfied in an application under
 35 U.S.C. 111(a) or in a
 national stage application under 35 U.S.C.
 371 , the applicant will be notified and given a
 period of time within which to comply with such requirements in order to
 prevent abandonment of the application. Subject to paragraph (d)(2) of
 this section, any amendment to add or replace a “Sequence Listing XML” or
 add an incorporation by reference of the material contained in the
 “Sequence Listing XML” in response to a requirement under this paragraph
 (d)(1) must be submitted in accordance with the requirements of
 paragraphs (a) through (c) of this section.
 

 
 

 
 *****

 

 
 

 Initial review by the pre-examination staff at the USPTO
 checks for compliance with formal matters. In order to ensure that an application is
 ready for examination, pre-examination staff check that applications containing
 disclosures of nucleotides and/or amino acid sequences have complied with the sequence
 listing rules. This means that for applications having a filing date on or after July 1,
 2022, containing such sequence disclosures, a “Sequence Listing XML” must be of record
 and if not, applicant will be notified of such deficiency and provided instructions for
 responding. Adding a “Sequence Listing XML” where one was not previously filed must
 conform with the requirements of 37 CFR 1.835(a) . See
 MPEP §
 2414.02 for details. To amend a “Sequence Listing XML” due to
 errors or omissions, the procedure is outlined in 37 CFR
 1.835(b) . See MPEP § 2414.03 for details.
 

 

 
 2414.02 Amendment to Add an Initial “Sequence Listing
 XML” under 37 CFR 1.835(a) [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 1.835 Amendment to add or replace a “Sequence
 Listing XML” in patent applications filed on or after July 1, 2022. 

 
 (a) Any amendment to a patent application adding an initial submission of a
 “Sequence Listing XML” as required by § 1.831(a) after the application filing date must
 include:
 
 (1) A “Sequence Listing XML” in accordance with §§ 1.831 through 1.834 , submitted as an XML file:
 
 (i) Via the USPTO patent electronic filing system; or

 (ii) On a read-only optical disc, in compliance with § 1.52(e) ;
 

 
 

 (2) A request to amend the specification to include an incorporation by
 reference statement of the material in the “Sequence Listing XML” file,
 identifying the name of the file, the date of creation, and the size of
 the file in bytes ( see § 1.77(b)(5)(ii) ), except when submitted to the
 United States International Preliminary Examining Authority for an
 international application;
 

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

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

 
 

 
 *****

 

 
 

 Part of the pre-examination process as well as initial
 review by the examiner involves identifying whether an application that discloses
 nucleotide and/or amino acid sequences requires submission of a “Sequence Listing XML,”
 and if so, if it contains a compliant “Sequence Listing XML.” If pre-examination staff
 identifies that a “Sequence Listing XML” is required but missing or that compliance with
 37 CFR
 1.831 - 1.835 is lacking, a notice
 indicating the deficiencies will be issued to the applicant. Similarly, upon having a
 new application placed on the examiner’s docket, the examiner can assess whether a
 disclosure of nucleotide and/or amino acid sequences in the application requires a
 “Sequence Listing XML” to be submitted where one has not been submitted. The examiner
 can identify the requirement for a “Sequence Listing XML” on an “OPAP Routing Sheet”
 (Document Code “SEQREQ”) and return the application to pre-examination for the mailing
 of a notice indicating the deficiencies.
 

 Applicant's response to a notice or an Office Action
 requiring an initial “Sequence Listing XML” would involve providing the following:
 

 
 (1) A compliant “Sequence Listing XML” submitted as an
 XML file using either the USPTO patent electronic filing system (currently, XML
 files can only be submitted via Patent Center) or a read-only optical disc that is
 mailed or hand-delivered into the Office. If the size of “Sequence Listing XML”
 file exceeds the upload limit of Patent Center, then it must be submitted on
 read-only optical disc. ( 37 CFR 1.835(a)(1) );
 

 (2) An amendment to the specification to incorporate
 by reference the material in the “Sequence Listing XML” by reciting in a separate
 paragraph of the specification the name of the file, the date of creation, and the
 size of the file in bytes ( 37 CFR 1.835(a)(2) and
 37 CFR 1.835(c) );
 

 (3) A statement identifying the basis for the added
 “Sequence Listing XML,” which would include, e.g., paragraphs of the originally
 filed specification or sheets of the drawings where a sequence is disclosed,
 identifying each sequence that is part of the “Sequence Listing XML”
 ( 37 CFR 1.835(a)(3) ); and
 

 (4) A statement that no new matter is introduced by
 the content of the “Sequence Listing XML” ( 37 CFR
 1.835(a)(4) ).
 

 
 

 
 2414.03 Amendment Adding to, Deleting from, or Replacing
 Sequence Information in a “Sequence Listing XML” under 37 CFR 1.835(b) [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 1.835 Amendment to add or replace a “Sequence
 Listing XML” in patent applications filed on or after July 1, 2022. 

 
 
 *****

 

 (b) Any amendment adding to, deleting from, or replacing sequence information in a
 “Sequence Listing XML” submitted as required by § 1.831(a) must include:
 
 (1) A replacement “Sequence Listing XML” in accordance with the requirements
 of §§ 1.831 through
 1.834 containing the
 entire “Sequence Listing XML,” including any additions, deletions, or
 replacements of sequence information, which shall be submitted:
 
 (i) Via the USPTO patent electronic filing system; or

 (ii) On a read-only optical disc, in compliance with § 1.52(e) , labeled as “REPLACEMENT MM/DD/YYYY”
 (with the month, day, and year of creation indicated);
 

 
 

 (2) A request to amend the specification to include an incorporation by
 reference statement of the material in the replacement “Sequence Listing
 XML” file that identifies the name of the file, the date of creation, and
 the size of the file in bytes ( see § 1.77(b)(5)(ii) ), except when the replacement
 “Sequence Listing XML” is submitted to the United States International
 Preliminary Examining Authority for an international application;
 

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

 (4) A statement that indicates the support for the additions, deletions, or
 replacements of the sequence information, with specific references to
 particular parts of the application as originally filed (specification,
 claims, drawings) for all amended sequence data in the replacement
 “Sequence Listing XML”; and
 

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

 
 

 
 *****

 

 
 

 Part of the pre-examination process as well as initial
 review by the examiner involves identifying whether an application that discloses
 nucleotide and/or amino acid sequences contains a compliant “Sequence Listing XML.” If
 pre-examination staff identifies that a previously submitted “Sequence Listing XML”
 contains errors and/or the application fails to comply with 37 CFR
 1.831 - 1.834 , a notice indicating the
 deficiencies will be issued to the applicant. Similarly, upon having a new application
 placed on the examiner’s docket, the examiner can identify errors in any “Sequence
 Listing XML” and/or instances of noncompliance with 37 CFR
 1.831 - 1.834 that might not have been
 identified by pre-examination staff. The examiner can identify the outstanding
 requirements on a “OPAP Routing Sheet” (Document Code “SEQREQ”) and return the
 application to pre-examination status for the mailing of a notice indicating the
 deficiencies.
 

 Applicant response to a notice or an Office action
 requiring a replacement “Sequence Listing XML” would involve submitting the
 following:
 

 
 (1) A compliant replacement “Sequence Listing XML”
 submitted as an XML file containing the entire “Sequence Listing XML,” including
 any additions, deletions, or replacements of sequence information, using either
 the USPTO patent electronic filing system (currently, XML files can only be
 submitted via Patent Center) or a read-only optical disc that is mailed or
 hand-delivered into the Office. If the size of “Sequence Listing XML” file exceeds
 the upload limit of Patent Center, then it must be submitted on read-only optical
 disc ( 37 CFR 1.835(b)(1) );
 

 (2) An amendment to the specification to incorporate by
 reference the material in the replacement “Sequence Listing XML” by reciting in a
 separate paragraph of the specification the name of the file, the date of
 creation, and the size of the file in bytes ( 37 CFR
 1.835(b)(1) and 37 CFR
 1.835(c) );
 

 (3) A statement that identifies the location of all
 additions, deletions, or replacements of sequence information relative to the
 replaced “Sequence Listing XML” ( 37 CFR 1.835(b)(3) );
 

 (4) A statement identifying the basis for the
 additions, deletions, or replacements of the sequence information in the
 application as originally filed for all amended sequence data in the replacement
 “Sequence Listing XML,” which would include, e.g., paragraphs of specification or
 sheets of the drawings where a sequence is disclosed, identifying the sequence
 which is part of the replacement “Sequence Listing XML” ( 37 CFR
 1.835(b)(4) ); and
 

 (5) A statement that no new matter is introduced by
 the content of the replacement “Sequence Listing XML” ( 37 CFR
 1.835(b)(5) ).
 

 
 If applicant recognizes a deficiency in a previously
 submitted “Sequence Listing XML” or otherwise chooses to amend a previously submitted
 “Sequence Listing XML,” a replacement “Sequence Listing XML” must be filed including all
 of the above-described items.
 

 

 
 2414.04 Translation of “Sequence Listing XML” is Not an
 Amended “Sequence Listing XML” under 37 CFR 1.835(b) [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) . Formatting
 representations of XML (eXtensible Markup Language) elements in this section appear
 different than shown in Standard ST.26, which may be accessed at: 
 www.wipo.int
 /export/sites/www/standards/en/pdf/03-26-01.pdf .] 

 
 37 CFR 1.835 Amendment to add or replace a “Sequence
 Listing XML” in patent applications filed on or after July 1, 2022. 

 
 
 *****

 

 (d)(2) Compliance with paragraphs (a) through (c) of this section is not required for
 submission of a “Sequence Listing XML” that is solely an English translation of
 a previously submitted “Sequence Listing XML” that contains non-English values
 for any language-dependent free text elements (as per § 1.833(b)(3) ). The required submission will be a
 translated “Sequence Listing XML” in compliance with §§ 1.831 through 1.834 . Updated values for attributes in the root element
 (§ 1.833(b)(2)(iii) ) or
 elements of the general information part (§ 1.833(b)(2)(iv) ) are not considered amendments for
 purposes of complying with paragraphs (a) through (c) of this section.
 

 
 *****

 

 
 

 In accordance with 37 CFR 1.52(b)(1)(ii) , any:
 

 
 “application or proceeding and any amendments or
 corrections to the application (including any translation submitted pursuant to
 paragraph (d) of this section) or proceeding, except as provided for in §
 1.69 and paragraph (d) of this section, must:
 

 ***** 

 (ii) Be in the English language or be accompanied by
 a translation of the application and a translation of any corrections or amendments
 into the English language together with a statement that the translation is
 accurate.” 
 

 
 Thus, any “Sequence Listing XML” that contains one or
 more qualifiers having a free text value that is language-dependent must comprise an
 “INSDQualifier_value” element containing text in the English language, otherwise a
 translation of the “Sequence Listing XML” is required. 
 

 The provisions of 37 CFR
 1.835(d)(2) indicate that providing a translation of such
 language-dependent free text values into English in a new “Sequence Listing XML” does
 not constitute an added or amended “Sequence Listing XML” under 37 CFR
 1.835(a) or 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 [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 1.835 Amendment to add or replace a “Sequence
 Listing XML” in patent applications filed on or after July 1, 2022. 

 
 
 *****

 

 (e) If any of the requirements of §§ 1.831 through 1.834 are not satisfied at the time of filing an
 international application under the PCT, where the application is to be
 searched by the United States International Searching Authority or examined by
 the United States International Preliminary Examining Authority, the applicant
 may be sent a notice necessitating compliance with the requirements within a
 prescribed time period. Under PCT Rule 13ter, the
 applicant can provide, in response to such a requirement or otherwise, a
 sequence listing that is a “Sequence Listing XML” in accordance with §
 1.831(a) . The “Sequence
 Listing XML” must be accompanied by a statement that the information recorded
 does not go beyond the disclosure in the international application as filed. In
 response to such a requirement, the late furnishing fee set forth in §
 1.445(a)(5) is also
 required. If the applicant fails to timely provide the required “Sequence
 Listing XML,” the United States International Searching Authority shall search
 only to the extent that a meaningful search can be performed without the
 “Sequence Listing XML,” and the United States International Preliminary
 Examining Authority shall examine only to the extent that a meaningful
 examination can be performed without the “Sequence Listing XML.”
 

 
 *****

 

 
 

 Where an international application, filed under the PCT,
 contains a disclosure of nucleotide and/or amino acid sequences, PCT Rule 5.2 
 requires that the description shall include a sequence listing part of the description
 complying with the standard provided for in the Administrative Instructions (AI). In
 accordance with Section 208, any sequence listing, whether forming part of the
 international application or not forming part of the international application, shall
 comply with Annex C of the AI. Where applicant has not provided a sequence listing in
 accordance with Annex C of the AI and the USPTO acts as International Searching
 Authority (ISA) or International Preliminary Examining Authority (IPEA), the ISA/IPEA
 may invite applicant to furnish a sequence listing, with a late furnishing fee, under
 PCT Rule
 13ter . This invitation will specify a time
 limit for a proper response. A proper response to such an invitation would include, the
 submission of a sequence listing accordance with Annex C of the AI, the late furnishing
 fee specified in 37 CFR 1.445(a)(5) , and a statement
 to the effect that the sequence listing does not go beyond the disclosure of the
 international application as filed. If a sequence listing compliant with WIPO Standard
 ST.26 has not been furnished to the ISA/IPEA within the time limit set forth in the
 invitation, the ISA/IPEA will only search/examine the international application to the
 extent that a meaningful search or examination can be performed without the sequence
 listing.
 

 See MPEP §§ 1823.02 and
 1848 .
 

 

 
 2414.06 Amendment of a “Sequence Listing XML” in a
 Patent [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 1.835 Amendment to add or replace a “Sequence
 Listing XML” in patent applications filed on or after July 1, 2022. 

 
 
 *****

 

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

 
 

 Where an amendment is made to a “Sequence Listing XML”
 contained in a patent, the correction must be made by way of an amendment to the
 “Sequence Listing XML” contained in a patent, pursuant to 1.835(b) .
 

 

 [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 20:49:35