MPEP § 2427
[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.
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.
Specific deficiencies and the required response to this Office Action are as follows:
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 .
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 with1. 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.
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 with1. 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.
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); and1. 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.
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:
OR
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.
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.
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.
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:
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.
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 with1. 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.
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:
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.
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:
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.
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:
AND/OR
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.
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:
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.
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:
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.
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:
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.
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:
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.
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:
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.