¶ 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:
    • a) via EFS-Web (see Section I.1 of the Legal Framework for EFS-Web (https://www.uspto.gov/patents-application- process/filing-online/legal-framework-efs-web ), 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 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) on compact disc(s) in duplicate according to 37 CFR 1.52(e)(1)(ii)  and (4), labeled according to 37 CFR 1.52(e)(6), together with a statement that the duplicate compact discs are identical and an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(5)  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) via EFS-Web as a PDF (not recommended); or
    • d) on paper.
  • 2) 37 CFR 1.821(e)  requires that a copy of the "Sequence Listing" must also be submitted in computer readable form (CRF) in accordance with the requirements of 37 CFR 1.824.
    • a) If a "Sequence Listing" ASCII text file submitted via EFS-Web on the application filing date complies with the requirements of 37 CFR 1.824(a)(2)  - (6)  and (b), and applicant has not filed a "Sequence Listing" as a PDF, the text file will serve as both the "Sequence Listing" required by 37 CFR 1.821(c)  and the CRF required by 37 CFR 1.821(e), and the statement of identity under the "Legal Framework" is not required.
    • b) If the "Sequence Listing" required by 37 CFR 1.821(c)  is filed via EFS-Web as a PDF, then the "Legal Framework" requires submission of a statement that the "Sequence Listing" content of the PDF copy and the ASCII text file copy submitted via EFS-Web are identical.
    • c) If the "Sequence Listing" required by 37 CFR 1.821(c)  is filed on paper or compact disc, then 37 CFR 1.821(f)  requires submission of a statement that the "Sequence Listing" content of the paper or compact 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.

    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;
  • • A statement that the "Sequence Listing" includes no new matter; and
  • • A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825  and the "Legal Framework."
  • • 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 1.121(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; and
    • o A statement according to item 2) b) or c) above.

If applicant desires the CRF in this application to be identical with the CRF of another application on file in the U.S. Patent and Trademark Office, such request in accordance with 37 CFR 1.821(e)  may be submitted in lieu of a new CRF (form PTO/SB/93 may be used for this purpose).

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 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;
  • • A statement that the "Sequence Listing" includes no new matter; and
  • • A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825  and the "Legal Framework."
  • • 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 1.121(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; and
    • o A statement according to item 2) b) or c) above.

If applicant desires the CRF in this application to be identical with the CRF of another application on file in the U.S. Patent and Trademark Office, such request in accordance with 37 CFR 1.821(e)  may be submitted in lieu of a new CRF (form PTO/SB/93 may be used for this purpose).

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.

¶ 24.04    CRFE but No "Sequence Listing" part of the disclosure

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.

    Required response - Applicant must provide either:

  • • Where an ASCII text file was provided on the application filing date via EFS-Web, a substitute specification in compliance with 37 CFR 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.

OR

  • • A "Sequence Listing" part of the disclosure, as described above in any one of items 1) a), b), c), or d); together with
  • • An amendment specifically directing its entry into the application;
  • • Where the "Sequence Listing" is submitted under item 1) a) or b) a substitute specification in compliance with 37 CFR 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.
  • • A statement that the "Sequence Listing" added by amendment includes no new matter;
  • • A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825  and the "Legal Framework"; and
  • • A statement that the content of the previously-filed CRF is identical to the "Sequence Listing" part of the disclosure added by amendment, where provided under item 1) b), c), or d) (note that where a "Sequence Listing" part of the disclosure is provided under item 1) a), the text file will also serve as the CRF, and the statement of identity is not required).

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); however, a compliant CRF as required by 37 CFR 1.821(e)  has been submitted.

4. 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 is not the same as the CRF of the "Sequence Listing" as required by 37 CFR 1.821(e).

Required response - Applicant must provide either:

  • • A substitute "Sequence Listing" as described above in any one of items 1) a), b), c), or d); as well as
  • • An amendment specifically directing its entry into the application;
  • • A statement that the "Sequence Listing" added by amendment includes no new matter;
  • • A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825, and the "Legal Framework"; and
  • • A statement that the content of the previously-filed CRF is identical to the "Sequence Listing" part of the disclosure added by amendment, where provided under item 1) b), c), or d) (note that where a "Sequence Listing" part of the disclosure is provided under item 1) a), the text file will also serve as the CRF, and the statement of identity is not required);
  • • 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 1.121(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 substitute CRF; and
  • • A statement that the content of the CRF is identical to the "Sequence Listing" part of the disclosure, as required by 37 CFR 1.821(f)  and the "Legal Framework."

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, PDF, CD) 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(f)  or the "Legal Framework."

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 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)  as indicated in item 2) above.

Required response - Applicant must provide a CRF and statement according to item 2) b) or c) above. If applicant desires the CRF in this application to be identical with the CRF of another application on file in the U.S. Patent and Trademark Office, such request in accordance with 37 CFR 1.821(e)  may be submitted in lieu of a new CRF (form PTO/SB/93 may be used for this purpose).

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. A copy of the "Sequence Listing" in computer readable form (CRF) has been submitted; however, the content of the CRF does not comply with the requirements of 37 CFR 1.822  and/or 1.823, 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 "Sequence Listing" part of the disclosure, as described above in any one of items 1) a), b), c), or d); together with
  • • An amendment specifically directing its entry into the application;
  • • A statement that the "Sequence Listing" includes no new matter; and
  • • A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825  and the "Legal Framework."
  • • 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 1.121(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; and
    • o Statement according to item 2) b) or c) 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 media purported to contain the computer readable form (CRF) copy of the "Sequence Listing" filed with this application has been found to be damaged and/or unreadable as indicated on the attached CRF Diskette Problem Report.

Required response – Applicant must provide:

  • • a CRF copy of the "Sequence Listing"; and
  • • a statement according to item 2) b) or c) above.

If applicant desires the CRF in this application to be identical with the CRF of another application on file in the U.S. Patent and Trademark Office, such request in accordance with 37 CFR 1.821(e)  may be submitted in lieu of a new CRF (form PTO/SB/93 may be used for this purpose).

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 - 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 1.121(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 - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for 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 1.121(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 any one of items 1) a), b), c), or d); as well as
  • • An amendment specifically directing entry of the "Sequence Listing" part of the disclosure into the application;
  • • A statement that the "Sequence Listing" includes no new matter; and
  • • A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825  and the "Legal Framework."
  • • 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 1.121(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; and
    • o Statement according to item 2) b) or c) above.

If applicant desires the CRF in this application to be identical with the CRF of another application on file in the U.S. Patent and Trademark Office, such request in accordance with 37 CFR 1.821(e)  may be submitted in lieu of a new CRF (form PTO/SB/93 may be used for this purpose).

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 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 1.121(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" or the required Incorporation by Reference paragraph into the application.

Required response – Applicant must provide:

  • • A substitute specification in compliance with 37 CFR 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).

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).

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.