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

Ninth Edition of the MPEP, Revision 07.2022, Last Revised in February 2023

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2427    Form Paragraphs for Applications Subject to WIPO ST.25 [R-07.2022]

[Editor Note: This section is not applicable to applications filed on or after July 1, 2022, having disclosures of nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b). See MPEP §§ 2412-2419 for guidance on WIPO ST.26 requirements for applications filed on or after July 1, 2022.]

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, 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 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
  • 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 CFR 1.821(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 EFS-Web or Patent Center 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 with37 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:

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:

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.

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

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:

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 PAIR 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:

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 PAIR 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:

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.