¶ 24.17.26 Heading for ST.26 Sequence Requirements

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

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

• 1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https:// www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
  • a. the name of the XML file
  • b. the date of creation; and
  • c. the size of the XML file in bytes; or
• 2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
  • a. the name of the XML file;
  • b. the date of creation; and
  • c. the size of the XML file in bytes.

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

Examiner Note:

• 1. This form paragraph should only be used where compliance with 37 CFR 1.831-1.835 is not required for examination of the application, or where a lack of compliance with 37 CFR 1.831-1.835 arose during prosecution.
• 2. This form paragraph must be followed by one or more of form paragraphs 24.18.26 - 24.29.26.

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

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

Required response - Applicant must provide:

• • A "Sequence Listing XML" part of the disclosure, as described above in item 1. or 2.; together with
  • o A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed, as required by 37 CFR 1.835(a)(3);
  • o A statement that the "Sequence Listing XML" includes no new matter as required by 37 CFR 1.835(a)(4)
• AND
• • A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(a)(2), consisting of:
  •  A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
  •  A copy of the amended specification without markings (clean version); and
  •  A statement that the substitute specification contains no new matter.

Examiner Note:

• 1. This form paragraph should only be used where compliance with 37 CFR 1.831-1.835 is not required for examination of the application, or where a lack of compliance with 37 CFR 1.831-1.835 arose during prosecution.
• 2. This form paragraph must be preceded by form paragraph 24.17.26.
• 3. This form paragraph should be used for an application that has no "Sequence Listing XML" in compliance with 37 CFR 1.831-1.834. The examiner should explain why a “Sequence Listing XML” is required in <1>.
• 4. This form paragraph may be followed by one or more deficiency form paragraphs.

¶ 24.19.26 Defective “Sequence Listing XML”

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

Required response - Applicant must provide:

• • A replacement "Sequence Listing XML" part of the disclosure, as described above submitted in accordance with either item 1. or 2.; together with
  • o A statement that identifies the location of all additions, deletions or replacements of sequence information relative to the replaced “Sequence Listing XML” as required by 37 CFR 1.835(b)(3);
  • o A statement that indicates support for the replacement “Sequence Listing XML” in the application, as filed, as required by 37 CFR 1.835(b)(4); and
  • o A statement that the replacement "Sequence Listing XML" includes no new matter as required by 37 CFR 1.835(b)(5).
• AND
• • A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125, inserting the required incorporation-by-reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
  • o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
  • o A copy of the amended specification without markings (clean version); and
  • o A statement that the substitute specification contains no new matter.

Examiner Note:

• 1 This form paragraph should only be used where compliance with 37 CFR 1.831-1.835 is not required for examination of the application, or where a lack of compliance with 37 CFR 1.831-1.835 arose during prosecution.
• 2 This form paragraph must be preceded by form paragraph 24.17.26.
• 3 This form paragraph should be used for an application where a defective "Sequence Listing XML" was filed and a notice was sent to the applicant including the errors identified according to STIC.
• 4 This form paragraph may be followed by one or more deficiency form paragraphs.
• 5 This form paragraph would only be used when an applicant provides a disc of a “Sequence Listing XML” in reply to an examiner requirement for a “Sequence Listing XML.”

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

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

• • A replacement "Sequence Listing XML" part of the disclosure, as described above submitted in accordance with either item 1. or 2., together with
  • o A statement that identifies the location of all additions, deletions, or replacements of sequence information in the replacement “Sequence Listing XML” as required by 37 CFR 1.835(b)(3);
  • o A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
  • o A statement that the replacement "Sequence Listing XML" includes no new matter as required by 37 CFR 1.835(b)(5); and
  • o A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
    •  A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
    •  A copy of the amended specification without markings (clean version); and
    •  A statement that the substitute specification contains no new matter.

Examiner Note:

• 1. This form paragraph should only be used where compliance with 37 CFR 1.831-1.835 is not required for examination of the application, or where a lack of compliance with 37 CFR 1.831-1.835 arose during prosecution.
• 2. This form paragraph must be preceded by form paragraph 24.17.26.
• 3. This form paragraph should be used for an application where a defective "Sequence Listing XML" was filed and a notice was sent to the applicant including the errors according to STIC.
• 4. This form paragraph may be followed by one or more deficiency form paragraphs.

¶ 24.21.26 Sequence IDs not present in specification

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

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

• • A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• • A copy of the amended specification without markings (clean version); and
• • A statement that the substitute specification contains no new matter.

Examiner Note:

• 1. This form paragraph should only be used where compliance with 37 CFR 1.831-1.835 is not required for examination of the application, or where a lack of compliance with 37 CFR 1.831-1.835 arose during prosecution.
• 2. This form paragraph must be preceded by form paragraph 24.17.26.
• 3. This form paragraph should be used for an application where a sequence is embedded in the text of the description or claims of the patent application and reference has not also been made to the sequence by use of the sequence identifier, preceded by "SEQ ID NO:" or the like in the text of the description or claims.
• 4. This form paragraph may be followed by one or more deficiency form paragraphs.

¶ 24.22.26 Sequence IDs not present in drawings

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

Required response – Applicant must provide:

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

AND/OR

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

• • A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• • A copy of the amended specification without markings (clean version); and
• • A statement that the substitute specification contains no new matter.

Examiner Note:

• 1. This form paragraph should only be used where compliance with 37 CFR 1.831-1.835 is not required for examination of the application, or where a lack of compliance with 37 CFR 1.831-1.835 arose during prosecution.
• 2. This form paragraph must be preceded by form paragraph 24.17.26.
• 3. This form paragraph should be used for an application where a sequence is embedded in the text of the drawings and reference has not also been made to the sequence by use of the sequence identifier, preceded by "SEQ ID NO:X" or the like, in either the text of the drawings or the Brief Description or the Drawings.
• 4. This form paragraph may be followed by one or more deficiency form paragraphs.

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

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

• • A replacement "Sequence Listing XML" part of the disclosure, as described above in item 1. or 2., as well as
• • A statement that identifies the location of all additions, deletions, or replacements of sequence information in the “Sequence Listing XML” as required by 37 CFR 1.835(b)(3);
• • A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4);
• • A statement that the "Sequence Listing XML" includes no new matter in accordance with 37 CFR 1.835(b)(5); and
• • A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
  • o A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
  • o A copy of the amended specification without markings (clean version); and
  • o A statement that the substitute specification contains no new matter.

Examiner Note:

• 1. This form paragraph should only be used where compliance with 37 CFR 1.831-1.835 is not required for examination of the application, or where a lack of compliance with 37 CFR 1.831-1.835 arose during prosecution.
• 2. This form paragraph must be preceded by form paragraph 24.17.26.
• 3. Examiner needs to identify the sequences missing from the “Sequence Listing XML” that were found in the claims, drawing or specification in <1>.
• 4. This form paragraph may be followed by one or more deficiency form paragraphs.

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

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

Required response - Applicant must:

• • Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
  • • A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
  • • A copy of the amended specification without markings (clean version); and
  • • A statement that the substitute specification contains no new matter.

Examiner Note:

• 1. This form paragraph should only be used where compliance with 37 CFR 1.831-1.835 is not required for examination of the application, or where a lack of compliance with 37 CFR 1.831-1.835 arose during prosecution.
• 2. This form paragraph must be preceded by form paragraph 24.17.26.
• 3. This form paragraph should be used for an application where incorporation by reference paragraph is missing, defective or incomplete. The examiner should clearly specify how any defective incorporation by reference paragraphs is non-compliant, if applicable.
• 4. The form paragraph maybe used when the incorporation by reference paragraphs provides erroneous information on the size of the sequence listing XML file, recites the size in kilobytes (KB) instead of bytes, and/or the file name for the sequence listing XML contains an error.
• 5. This form paragraph may be followed by one or more deficiency form paragraphs.

¶ 24.25.26 Amendment Missing Statement of No New Matter

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

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

Examiner Note:

• 1. This form paragraph should only be used where a compliant “Sequence Listing XML” is not required for examination of the application.
• 2. This form paragraph must be preceded by form paragraph 24.17.26.
• 3. This form paragraph should be used for an application where the statement of no new matter is missing.
• 4. This form paragraph may be followed by one or more deficiency form paragraphs.

¶ 24.26.26 Amendment Missing Statement of Support

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

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

Examiner Note:

• 1. This form paragraph should only be used where compliance with 37 CFR 1.831-1.835 is not required for examination of the application, or where a lack of compliance with 37 CFR 1.831-1.835 arose during prosecution.
• 2. This form paragraph must be preceded by form paragraph 24.17.26.
• 3. This form paragraph should be used for an application where the statement that indicates the basis for the “Sequence Listing XML” is missing.
• 4. This form paragraph may be followed by one or more deficiency form paragraphs.

¶ 24.27.26 “Sequence Listing XML” contains foreign language text

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

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

Examiner Note:

• 1. This form paragraph should only be used where compliance with 37 CFR 1.831-1.835 is not required for examination of the application, or where a lack of compliance with 37 CFR 1.831-1.835 arose during prosecution.
• 2. This form paragraph must be preceded by form paragraph 24.17.26.
• 3. This form paragraph should be used for an application where the “Sequence Listing XML” contains foreign text in the language-dependent free text elements.
• 4. This form paragraph may be followed by one or more deficiency form paragraphs.

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

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

Required response - Applicant must provide:

• • A replacement "Sequence Listing XML" part of the disclosure, as described above in item 1. or 2., as well as
  • o A statement that identifies the location of all additions, deletions, or replacements of sequence information in the replacement “Sequence Listing XML” as required by 37 CFR 1.835(b)(3);
  • o A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.835(b)(4),
  • o A statement that the replacement "Sequence Listing XML" includes no new matter in accordance with 37 CFR 1.835(b)(5), and
  • o A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph as required by 37 CFR 1.835(b)(2), consisting of:
    •  A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
    •  A copy of the amended specification without markings (clean version); and
    •  A statement that the substitute specification contains no new matter.

Examiner Note:

• 1. This form paragraph should only be used where compliance with 37 CFR 1.831-1.835 is not required for examination of the application, or where a lack of compliance with 37 CFR 1.831-1.835 arose during prosecution.
• 2. This form paragraph must be preceded by form paragraph 24.17.26.
• 3. This form paragraph should be used for an application where there is a discrepancy between the “Sequence Listing XML” bibliographic information and the application information in an application filed under 35 U.S.C. 111(a), if the application is a national stage, then the examiner should contact IPLA.
• 4. This form paragraph may be followed by one or more deficiency form paragraphs.

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

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

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

Examiner Note:

• 1. This form paragraph should only be used where compliance with 37 CFR 1.831-1.835 is not required for examination of the application, or where a lack of compliance with 37 CFR 1.831-1.835 arose during prosecution.
• 2. This form paragraph must be preceded by form paragraph 24.17.26.
• 3. This form paragraph should be used for an application where the replacement “Sequence Listing XML” is not accompanied by a statement that indicates the location of all additions, deletions or replacements in the sequence information.
• 4. This form paragraph may be followed by one or more deficiency form paragraphs.