MPEP § 2427 — MPEP § 2427
Current through: 2022-07-01

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

 
 
 
 
 
 
 
 

 

 
 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

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 Manual of Patent Examining Procedure 

 Chapter 2400 

 Section 2427 
 

 
 
 
 
 
 2427 Form Paragraphs for Applications Subject to WIPO ST.25 [R-01.2024]

 [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.] 

 See MPEP §
 608.05 for form paragraphs which should be used when notifying
 applicant that a read-only optical disc submitted in accordance with 37 CFR 1.52(e) (i.e.,
 containing a “Computer Program Listing Appendix”, “Sequence Listing”, and/or “Large
 Tables”) does not comply with all of the requirements of the 37 CFR 1.52(e) . See
 also MPEP §
 608.05(b) for form paragraphs which should be used when a table
 submitted on read-only optical disc does not comply with 37 CFR 1.52(e) . 
 

 In order to expedite the processing of applications, minor errors
 pertaining to compliance with the sequence rules discovered after examination has begun may
 be handled with the next Office action. Examples of minor errors are: missing any necessary
 sequence identifiers in the specification/drawings; missing or providing an incomplete
 incorporation by reference of the “Sequence Listing” in the specification (if required);
 and missing statement that the sequence information contained in the “Sequence Listing” is
 identical to the sequence information contained in the computer readable form (if
 required). Since the application is ready for examination, the examiner may act on the
 application and include any objections to the application based on minor errors related to
 the “Sequence Listing” or the CRF of the “Sequence Listing” with the Office action.
 

 

 ¶ 24.01 Heading for Sequence Requirements

 REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE
 DISCLOSURES 

 Items 1) and 2) provide general guidance related to requirements for sequence
 disclosures. 

 
 

 
 
 1) 37 CFR
 1.821(c) requires that patent applications which contain
 disclosures of nucleotide and/or amino acid sequences that fall within the
 definitions of 37
 CFR 1.821(a) must contain a "Sequence Listing," as a
 separate part of the disclosure , whichpresents the nucleotide and/or
 amino acid sequences and associated information using the symbols and format in
 accordance with the requirements of 37 CFR 1.821 1.825 . This "Sequence Listing" part of the disclosure may
 be submitted: 
 
 a) In accordance with 37 CFR
 1.821(c)(1) 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") as an ASCII text file, together with an
 incorporation-by-reference of the material in the ASCII text file in a
 separate paragraph of the specification as required by 37
 CFR1.823(b)(1) identifying: 
 
 i) the name of the ASCII text file;

 ii) the date of creation; and 

 iii) the size of the ASCII text file in bytes;

 
 

 b) In accordance with 37
 CFR1.821(c)(1) on read-only optical disc(s) as
 permitted by 37 CFR1.52(e)(1)(ii) , labeled
 according to 37 CFR1.52(e)(5) , with an
 incorporation-by-reference of the material in the ASCII text file according
 to 37 CFR1.52(e)(8) and
 37 CFR1.823(b)(1) in a
 separate paragraph of the specification identifying: 
 
 i) the name of the ASCII text file;

 ii) the date of creation; and

 iii) the size of the ASCII text file in bytes;

 
 

 c) In accordance with 37 CFR
 1.821(c)(2) via the USPTO patent electronic filing
 system as a PDF file(not recommended); or 
 

 d) In accordance with 37 CFR
 1.821(c)(3) on physical sheets of paper (not
 recommended). 
 

 
 

 2) When a “Sequence Listing” has been submitted as a PDF file
 as in 1.c) above ( 37 CFR 1.821(c)(2) ) or on
 physical sheets of paper as in 1. d) above ( 37 CFR
 1.821(c)(3) , 37 CFR1.821(e)(1) ), requires a
 computer readable form (CRF) of the “Sequence Listing” in accordance with the
 requirements of 37
 CFR 1.824 . 
 
 a) If the "Sequence Listing" required by
 37 CFR
 1.821(c) is filed via the USPTO patent electronic
 filing system as a PDF,then 37 CFR 1.821(e)(1)(ii) 
 or 1.821(e)(2)(ii) requires
 submission of a statement that the"Sequence Listing" content of the PDF copy
 and the CRF copy (the ASCII text file copy) are identical. 
 

 b) If the "Sequence Listing" required by
 37 CFR
 1.821(c) is filed on paper or read-only optical
 disc,then 37 CFR 1.821(e)(1)(ii) 
 or 1.821(e)(2)(ii) requires
 submission of a statement that the"Sequence Listing" content of the paper or
 read-only optical disc copy and the CRF are identical. 
 

 
 

 
 Specific deficiencies and the required response to this Office Action are as
 follows: 

 Examiner Note:
 
 1. This form paragraph should only be used for sequence listing
 non-compliance where a compliant sequence listing is not required for examination of
 the application.
 

 2. 
 This form paragraph must be followed by any of form paragraphs 
 24.02 24.16 
 .
 
 
 
 

 ¶ 24.02 No Sequence Listing part of the disclosure and No CRF

 Specific deficiency - This application fails to comply with the
 requirements of 37 CFR
 1.821 - 1.825 because it does not contain a
 "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence
 Listing”.
 

 
 Required response - Applicant must provide:
 

 • A "Sequence Listing" part of the disclosure; together
 with 

 • An amendment specifically directing its entry into the
 application in accordance with 37 CFR 1.825(a)(2) ; 

 • A statement that the "Sequence Listing" includes no new
 matter as required by 37 CFR 1.825(a)(4) ; and 
 

 • A statement that indicates support for the amendment in the
 application, as filed, as required by 37 CFR 1.825(a)(3) . 
 

 • If the "Sequence Listing" part of the disclosure is submitted
 according to item 1) a) or b) above,
 

 Applicant must also provide:
 
 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, 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.
 

 
 

 
 

 • If the "Sequence Listing" part of the disclosure is submitted
 according to item 1) b), c), or d) above, Applicant must also provide:
 
 o A CRF in accordance with 37 CFR
 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5) ; and 
 

 o A statement according to item 2) a) or b) above. 

 
 

 
 Examiner Note:
 
 1. This form paragraph must be preceded by form paragraph
 24.01 .
 

 2. This form paragraph should only be used for sequence listing
 non-compliance where a compliant sequence listing is not required for examination of the
 application.
 

 3. This form paragraph should be used for an application that has
 no "Sequence Listing" part of the disclosure as required by 37 CFR 1.821(c) 
 and no CRF as required by 37 CFR 1.821(e) .
 

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

 ¶ 24.03 No Sequence Listing part of the disclosure and Defective CRF

 Specific deficiency - This application fails to comply with the
 requirements of 37 CFR
 1.821 - 1.825 because it does not contain a
 "Sequence Listing" as a separate part of the disclosure and the CRF of the "Sequence Listing"
 is defective.
 

 
 Required response - Applicant must provide:
 

 • A "Sequence Listing" part of the disclosure, as described
 above in item 1); together with 

 • An amendment specifically directing its entry into the
 application in accordance with 37 CFR 1.825(a)(2) ; 

 • A statement that the "Sequence Listing" includes no new
 matter as required by 37 CFR 1.825(a)(4) ; and 
 

 • A statement that indicates support for the amendment in the
 application, as filed, as required by 37 CFR 1.825(a)(3) . 
 

 • If the "Sequence Listing" part of the disclosure is submitted
 according to item 1) a) or b) above, Applicant must also provide:
 
 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, 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.
 

 
 

 
 

 • If the "Sequence Listing" part of the disclosure is submitted
 according to item 1) c) or d) above, Applicant must also provide: 
 
 o A CRF in accordance with 37 CFR
 1.821(e)(1) or 1.821(e)(2) as required by 37 CFR
 1.825(a)(5) ; and 
 

 o A statement according to item 2) a) or b) above.

 
 

 
 Examiner Note:
 
 1. This form paragraph must be preceded by form paragraph
 24.01 .
 

 2. This form paragraph should only be used for sequence listing
 non-compliance where a compliant sequence listing is not required for examination of the
 application.
 

 3. This form paragraph should be used for an application that has
 no "Sequence Listing" part of the disclosure as required by 37 CFR 1.821(c) 
 and the CRF as required by 37 CFR 1.821(e) is defective.
 

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

 ¶ 24.17 Improper CRF transfer request

 Specific deficiency - The present application contains a
 "Sequence Listing" submitted as either a PDF file pursuant to 37 CFR
 1.821(c)(2) or as physical sheets of paper pursuant to 37 CFR
 1.821(c)(3) . No computer readable form (CRF) of the “Sequence Listing”
 pursuant to 37
 CFR 1.821(e)(1) has been received. In lieu of the CRF, Applicant has
 filed a request to transfer the CRF from a related or other application of the applicant to
 the present application to comply with the requirement in 37 CFR
 1.821(e)(1) . As of November 15, 2021, the practice of transferring a CRF
 from a previously-filed application of applicant into the present application in order to
 comply with 37
 CFR 1.821(e)(1) has been eliminated.
 

 
 Required response - Applicant must provide:
 

 • A new CRF of the “Sequence Listing” in accordance with
 37 CFR
 1.821(e)(1)(i) or 1.821(e)(2)(i) ; and
 

 • A statement that the content of the CRF is identical to the
 "Sequence Listing" part of the disclosure submitted as a PDF file ( 37 CFR
 1.821(c)(2) ) or on physical sheets of paper ( 37 CFR
 1.821(c)(3) ), as required by 37 CFR
 1.821(e)(1)(ii) or 1.821(e)(2)(ii) .
 

 
 Examiner Note:
 
 1. This form paragraph must be preceded by form paragraph
 24.01.
 

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

 ¶ 24.05 The “Sequence Listing” part of the disclosure and the CRF are not the same

 Specific deficiency - This application fails to comply with the
 requirements of 37 CFR
 1.821 - 1.825 because the "Sequence Listing" part
 of the disclosure submitted as a PDF file ( 37 CFR 1.821(c)(2) ) or on physical sheets
 of paper ( 37 CFR
 1.821(c)(3) )is not the same as the CRF of the "Sequence Listing" as
 required by 37
 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) .
 

 Required response - Applicant must provide:
 

 
 • A replacement "Sequence Listing" as described above in items
 1) c) or d) in accordance with 37 CFR 1.825(b)(1)(ii) or (iii) ;
 as well as 

 • An amendment specifically directing its entry into the
 application as required by 37 CFR 1.825(b)(2)(ii) ;
 

 • A statement that identified the locations of any deletions,
 replacements or additions to the “Sequence Listing” as required by 37 CFR
 1.825(b)(3) ;
 

 • A statement that the "Sequence Listing" added by amendment
 includes no new matter as required by 37 CFR 1.825(b)(5) ;
 

 • A statement that indicates support for the amendment in the
 application, as filed, as required by 37 CFR 1.825(b)(4) ; and
 

 • A statement that the content of the previously-filed CRF is
 identical to the "Sequence Listing" part of the disclosure added by amendment as
 required by 37 CFR 1.825(b)(7) , where provided
 under item 1) c) or d) (note that where a "Sequence Listing" part of the disclosure is
 provided under item 1) a) or b), the text file will also serve as the CRF, and the
 statement of identity is not required);
 

 
 OR

 
 • A CRF as required by 37 CFR
 1.821(e)(1) or 1.821(e)(2) ; and 
 

 • A statement that the content of the CRF is identical to the
 "Sequence Listing" part of the disclosure previously submitted as a PDF file
 ( 37 CFR
 1.821(c)(2) ) or on physical sheets of paper ( 37 CFR
 1.821(c)(3) ), as required by 37 CFR
 1.821(e)(1)(ii) or 1.821(e)(2)(ii) .
 

 
 Examiner Note:
 
 1. This form paragraph must be preceded by 24.01 .
 

 2. This form paragraph should only be used for sequence listing
 non-compliance where a compliant sequence listing is not required for examination of the
 application.
 

 3. This form paragraph should be used for an application in which
 the "Sequence Listing" part of the disclosure as required by 37 CFR 1.821(c) is not the
 same as the CRF as required by 37 CFR 1.821(e) .
 

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

 ¶ 24.06 Missing statement that the “Sequence Listing” (paper or PDF)
 and the CRF are the same
 

 Specific deficiency - This application fails to comply with the
 requirements of 37 CFR
 1.821 - 1.825 because the application does not
 contain a statement that the CRF is identical to the "Sequence Listing" part of the
 disclosure, as described above in item 1), as required by 37 CFR
 1.821(e)(1)(ii) or 1.821(e)(2)(ii) .
 

 Required response - Applicant must provide such
 statement.
 

 Examiner Note:
 
 1. This form paragraph must be preceded by form paragraph
 24.01 .
 

 2. This form paragraph should only be used for sequence listing
 non-compliance where a compliant sequence listing is not required for examination of the
 application.
 

 3. This form paragraph should be used for an application that is
 missing the statement that the CRF is identical to the "Sequence Listing" part of the
 disclosure.
 

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

 ¶ 24.07 No Computer Readable Form (CRF) submitted

 Specific deficiency - This application contains a "Sequence
 Listing as a PDF file ( 37 CFR 1.821(c)(2) ) or as physical sheets
 of paper ( 37 CFR
 1.821(c)(3) , but fails to comply with the requirements of
 37 CFR
 1.821 - 1.825 because a copy of the "Sequence
 Listing" in computer readable form (CRF) has not been submitted as required by
 37 CFR
 1.821(e)(1)(i) or 1.821(e)(2)(i) as indicated in item 2)
 above.
 

 Required response - Applicant must provide:
 

 
 • A new CRF of the "Sequence Listing" in accordance with 37
 37 CFR
 1.821(e)(1)(i) or 1.821(e)(2)(i) and
 

 • A statement that the content of the CRF is identical of the
 “Sequence Listing” part of the disclosure, submitted as a PDF file ( 37 CFR
 1.821(c)(2) ) or on physical sheets of paper ( 37 CFR
 1.821(c)(3) ), as required by 37 CFR
 1.821(e)(1)(ii) or 1.821(e)(2)(ii) .
 

 
 Examiner Note:
 
 1. This form paragraph must be preceded by form paragraph
 24.01 .
 

 2. This form paragraph should only be used for sequence listing
 non-compliance where a compliant sequence listing is not required for examination of the
 application.
 

 3. This form paragraph should be used for an application that is
 missing the CRF.
 

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

 ¶ 24.08 Computer Readable Form (CRF) contains error(s) according to STIC report

 Specific deficiency - This application fails to comply with the
 requirements of 37 CFR
 1.821 - 1.825 . This application contains a
 "Sequence Listing" as a PDF file ( 37 CFR 1.821(c)(2) ) or as physical sheets
 of paper ( 37 CFR
 1.821(c)(3) ). A copy of the "Sequence Listing" in computer readable form
 (CRF) has been submitted; however, the content of the CRF does not comply with one or more of
 the requirements of 37 CFR
 1.822 through 1.824 , as indicated in the "Error Report" that
 indicates the "Sequence Listing" could not be accepted. Refer to attachment or document
 "Computer Readable Form (CRF) for Sequence Listing – Defective" dated [1] .
 

 
 Required response – Applicant must provide:
 

 • A replacement "Sequence Listing" part of the disclosure, as
 described above in item 1); together with 

 • An amendment specifically directing its entry into the
 application in accordance with 37 CFR 1.825(b)(2) ; 
 

 • A statement that the "Sequence Listing" includes no new matter
 as required by 37 CFR 1.825(b)(5) ; and 
 

 • A statement that indicates support for the amendment in the
 application, as filed, as required by 37 CFR 1.825(b)(4) . 
 

 • If the replacement "Sequence Listing" part of the disclosure
 is submitted according to item 1) a) or b) above, Applicant must also provide:
 
 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, 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 and
 

 - An amendment to the specification to remove the
 “Sequence Listing previously submitted as a PDF file ( 37 CFR 1.821(c)(2) ) or
 as physical sheets of paper ( 37 CFR 1.821(c)(3) )
 

 
 

 
 

 • If the replacement "Sequence Listing" part of the disclosure
 is submitted according to item 1) c) or d) above, Applicant must also provide:
 
 o A CRF in accordance with 1.821(e)(1) or 1.821(e)(2) as
 required by 37 CFR 1.825(b)(6)(ii) ; and 
 

 o Statement according to item 2) a) or b) above. 

 
 

 
 Examiner Note:
 
 1. This form paragraph must be preceded by form paragraph
 24.01 .
 

 2. This form paragraph should only be used for sequence listing
 non-compliance where a compliant sequence listing is not required for examination of the
 application.
 

 3. This form paragraph should be used for an application where the
 CRF is defective.
 

 4. In bracket 1, insert the date of the appropriate document.

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

 ¶ 24.09 Computer Readable Form (CRF) damaged or unreadable

 Specific deficiency - The ASCII .txt file purported to contain the computer
 readable form (CRF) copy of the "Sequence Listing" filed with this application in accordance
 with 37 CFR
 1.821(c) has been found to be damaged, unreadable, or otherwise contains
 an error as indicated on document "Computer Readable Form (CRF) for Sequence Listing -
 Defective" dated. 
 

 Required response – Applicant must provide:
 

 
 • a replacement "Sequence Listing" in the form of an ASCII
 plain text file under 37 CFR 1.821(c) as provided for in 37 CFR
 1.825(b)(1)(i) , together with 
 

 • An amendment specifically directing its entry into the
 application in accordance with 37 CFR 1.825(b)(3) ; 
 

 • A statement that the "Sequence Listing" includes no new
 matter as required by 37 CFR 1.825(b)(5) ; and 
 

 • A statement that indicates support for the amendment in the
 application, as filed, as required by 37 CFR 1.825(b)(4) . 
 

 • 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; 
 

 
 

 OR 

 • A "Sequence Listing" part of the disclosure, as described
 above in item 1 c) or 1 d) as provided for in 37 CFR 1.825(b)(1)(ii) or
 1.825(b)(1)(iii) ; together with 

 • An amendment specifically directing its entry into the
 application in accordance with 37 CFR 1.825(b)(2) ;
 

 • A statement that the "Sequence Listing" includes no new
 matter as required by 37 CFR 1.825(b)(5) ; and 
 

 • A statement that indicates support for the amendment in the
 application, as filed, as required by 37 CFR 1.825(b)(4) . 
 

 • When the "Sequence Listing" part of the disclosure is
 submitted according to item 1 c), or 1 d) above, Applicant must also provide: 
 
 • A CRF in accordance with 37 CFR 1.821(e)(1) as required
 by 37 CFR 1.825(b)(6) ; and
 

 • a statement according to item 2) a) or b) above.

 
 

 
 Examiner Note:
 
 1. This form paragraph must be preceded by form paragraph
 24.01 .
 

 2. This form paragraph should only be used for sequence listing
 non-compliance where a compliant sequence listing is not required for examination of the
 application.
 

 3. This form paragraph should be used for an application where the
 CRF is damaged or unreadable, e.g., SCORE - CRF Problem Report.
 

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

 ¶ 24.10 Sequence IDs not present in the specification

 Specific deficiency - Nucleotide and/or amino acid sequences
 appearing in the specification are not identified by sequence identifiers in accordance with
 37 CFR
 1.821(d) .
 

 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: 
 
 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 must be preceded by form paragraph
 24.01 .
 

 2. This form paragraph should only be used for sequence listing
 non-compliance where a compliant sequence listing is not required for examination of the
 application.
 

 3. This form paragraph should be used for an application where
 reference has not been made to the sequence by use of the sequence identifier, preceded
 by "SEQ ID NO:" in the text of the description or claims, even if the sequence is also
 embedded in the text of the description or claims of the patent application.
 

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

 ¶ 24.11 Sequence IDs not present in the drawings

 Specific deficiency - Nucleotide and/or amino acid sequences
 appearing in the drawings are not identified by sequence identifiers in accordance with
 37 CFR
 1.821(d) . Sequence identifiers for nucleotide and/or amino acid
 sequences must appear either in the drawings or in the Brief Description of the Drawings.
 

 Required response – Applicant must provide: 
 

 
 • Replacement and annotated 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 into the Brief Description of the Drawings, 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 must be preceded by form paragraph
 24.01 .
 

 2. This form paragraph should only be used for sequence listing
 non-compliance where a compliant sequence listing is not required for examination of the
 application.
 

 3. This form paragraph should be used for an application where
 reference has not been made to the sequence by use of the sequence identifier, preceded
 by "SEQ ID NO:" 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.
 
 
 

 ¶ 24.12 Sequences present in the specification or drawings that are
 not in the CRF or listing
 

 Specific deficiency - This application contains sequence
 disclosures in accordance with the definitions for nucleotide and/or amino acid sequences set
 forth in 37 CFR
 1.821(a)(1) and (a)(2) . However, this application fails to
 comply with the requirements of 37 CFR 1.821 - 1.825 .
 

 The sequence disclosures are located [1] .
 

 Required response – Applicant must provide:
 

 
 • A "Sequence Listing" part of the disclosure, as described
 above in item 1); as well as 

 • An amendment specifically directing entry of the
 "Sequence Listing" part of the disclosure into the application in accordance with
 1.825(b)(2); 

 • A statement that the "Sequence Listing" includes no new
 matter in accordance with 1.825(b)(5) ; and
 

 • A statement that indicates support for the amendment in the
 application, as filed, as required by 37 CFR 1.825(b)(4) .
 

 • If the "Sequence Listing" part of the disclosure is submitted
 according to item 1) a) or b) above, Applicant must also provide:
 
 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, 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;
 

 
 

 
 

 • If the "Sequence Listing" part of the disclosure is submitted
 according to item 1) b), c), or d) above, Applicant must also provide:
 
 o A replacement CRF in accordance with 1.825(b)(6) ;
 and
 

 o Statement according to item 2) a) or b) above.

 
 

 
 Examiner Note:
 
 1. This form paragraph must be preceded by form paragraph
 24.01 .
 

 2. This form paragraph should only be used for sequence listing
 non-compliance where a compliant sequence listing is not required for examination of the
 application.
 

 3. This form paragraph should be used for an application
 containing sequence disclosures that are not contained in the Sequence Listing or
 CRF.
 

 4. In bracket 1, insert the specific location of the sequence
 disclosures that are not contained in the Sequence Listing or CRF.
 

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

 ¶ 24.13 Missing or Defective Incorporation by Reference Paragraph

 Specific deficiency - The Incorporation by Reference paragraph
 required by 37 CFR
 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
 

 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: 
 
 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 must be preceded by form paragraph
 24.01 .
 

 2. This form paragraph should only be used for sequence listing
 non-compliance where a compliant sequence listing is not required for examination of the
 application.
 

 3. This form paragraph should only be used for a sequence listing
 under 1) a) or 1) b) in form paragraph 24.01 , where the incorporation-by-reference
 paragraph is missing. 
 

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

 ¶ 24.14 Amendment Missing Instruction to Enter the “Sequence Listing” into the Application

 Specific deficiency – The "Sequence Listing" has not been
 entered into the application because the amendment does not direct entry of either the
 "Sequence Listing" (as required by 37 CFR 1.825(a)(2) or 1.825(b)(2) )
 or contain the required Incorporation by Reference paragraph into the application. 
 

 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: 
 
 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 must be preceded by form paragraph
 24.01 .
 

 2. This form paragraph should only be used for sequence listing
 non-compliance where a compliant sequence listing is not required for examination of the
 application.
 

 3. This form paragraph should only be used where the instruction
 to enter the "Sequence Listing" into the application is missing. 
 

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

 ¶ 24.15 Amendment Missing Statement of No New Matter

 Specific deficiency – The "Sequence Listing" has not been
 entered into the application because the required statement of no new matter is missing. See
 37 CFR
 1.825(a)(4) or 1.825(b)(5) . 
 

 Required response – Applicant must provide: 
 

 
 • A proper statement of no new matter.

 
 Examiner Note:
 
 1. This form paragraph must be preceded by form paragraph
 24.01 .
 

 2. This form paragraph should only be used for sequence listing
 non-compliance where a compliant sequence listing is not required for examination of the
 application.
 

 3. This form paragraph should only be used for an amendment that
 is missing the statement of no new matter. 
 

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

 ¶ 24.16 Amendment Missing Statement of Support

 Specific deficiency – The "Sequence Listing" has not been
 entered into the application because the required statement of support is missing. See
 37 CFR
 1.825(a)(3) or 1.825(b)(4) . 
 

 Required response – Applicant must provide: 
 

 
 • A proper statement of support.

 
 Examiner Note:
 
 1. This form paragraph must be preceded by form paragraph
 24.01 .
 

 2. This form paragraph should only be used for sequence listing
 non-compliance where a compliant sequence listing is not required for examination of the
 application.
 

 3. This form paragraph should only be used for an amendment that
 is missing the statement of support.
 

 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 20:49:36