MPEP § 2414.01 — Issuance of a Notice Relating to the Requirements For Patent Applications Containing Nucleotide and/or Amino Acid Sequence Disclosures (Annotated Rules)

§2414.01 Issuance of a Notice Relating to the Requirements For Patent Applications Containing Nucleotide and/or Amino Acid Sequence Disclosures

USPTO MPEP version: BlueIron's Update: 2025-12-31

This page consolidates and annotates all enforceable requirements under MPEP § 2414.01, including statutory authority, regulatory rules, examiner guidance, and practice notes. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.

Issuance of a Notice Relating to the Requirements For Patent Applications Containing Nucleotide and/or Amino Acid Sequence Disclosures

This section addresses Issuance of a Notice Relating to the Requirements For Patent Applications Containing Nucleotide and/or Amino Acid Sequence Disclosures. Primary authority: 37 CFR 1.835(a), 37 CFR 1.835(b), and 37 CFR 1.835. Contains: 2 requirements and 2 other statements.

Key Rules

Topic

Sequence Listing Content

3 rules
StatutoryInformativeAlways
[mpep-2414-01-b2457bf248a90b8f9a87ed83]
Requirement for Sequence Disclosures in Patent Applications
Note:
This rule requires patent applications filed on or after July 1, 2022, to include disclosures of one or more nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b).

[Editor Note: This section is applicable to all applications with a filing date, or, for national phase applications, an international filing date, on or after July 1, 2022, having disclosure of one or more nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b).]

37 CFR 1.77 · 37 CFR 1.831(b)Sequence Listing ContentSequence Listing RequirementsSequence Listing Format
StatutoryInformativeAlways
[mpep-2414-01-0ae82649f34e1b451a08b2af]
Sequence Listing XML Required for Nucleotide and Amino Acid Disclosures
Note:
Pre-examination staff at the USPTO require a Sequence Listing XML for applications containing nucleotide or amino acid sequences filed on or after July 1, 2022.

Initial review by the pre-examination staff at the USPTO checks for compliance with formal matters. In order to ensure that an application is ready for examination, pre-examination staff check that applications containing disclosures of nucleotides and/or amino acid sequences have complied with the sequence listing rules. This means that for applications having a filing date on or after July 1, 2022, containing such sequence disclosures, a “Sequence Listing XML” must be of record and if not, applicant will be notified of such deficiency and provided instructions for responding. Adding a “Sequence Listing XML” where one was not previously filed must conform with the requirements of 37 CFR 1.835(a). See MPEP § 2414.02 for details. To amend a “Sequence Listing XML” due to errors or omissions, the procedure is outlined in 37 CFR 1.835(b). See MPEP § 2414.03 for details.

Jump to MPEP Source · 37 CFR 1.835(a)Sequence Listing ContentSequence Listing FormatSequence Listing Requirements
StatutoryRequiredAlways
[mpep-2414-01-c0cc2172ed596d7b0a88a8a2]
Sequence Listing XML Required for Filing After July 1, 2022
Note:
For applications filed on or after July 1, 2022, containing nucleotide and/or amino acid sequence disclosures, a Sequence Listing XML must be included.

Initial review by the pre-examination staff at the USPTO checks for compliance with formal matters. In order to ensure that an application is ready for examination, pre-examination staff check that applications containing disclosures of nucleotides and/or amino acid sequences have complied with the sequence listing rules. This means that for applications having a filing date on or after July 1, 2022, containing such sequence disclosures, a “Sequence Listing XML” must be of record and if not, applicant will be notified of such deficiency and provided instructions for responding. Adding a “Sequence Listing XML” where one was not previously filed must conform with the requirements of 37 CFR 1.835(a). See MPEP § 2414.02 for details. To amend a “Sequence Listing XML” due to errors or omissions, the procedure is outlined in 37 CFR 1.835(b). See MPEP § 2414.03 for details.

Jump to MPEP Source · 37 CFR 1.835(a)Sequence Listing ContentSequence Listing FormatSequence Listing Requirements
Topic

Sequence Listing Format

2 rules
StatutoryRequiredAlways
[mpep-2414-01-4ff96152b066d19faa1d1e4c]
Sequence Listing XML Must Conform to Requirements
Note:
For patent applications filed on or after July 1, 2022, a 'Sequence Listing XML' must be added and conform to the requirements of 37 CFR 1.835(a).

Initial review by the pre-examination staff at the USPTO checks for compliance with formal matters. In order to ensure that an application is ready for examination, pre-examination staff check that applications containing disclosures of nucleotides and/or amino acid sequences have complied with the sequence listing rules. This means that for applications having a filing date on or after July 1, 2022, containing such sequence disclosures, a “Sequence Listing XML” must be of record and if not, applicant will be notified of such deficiency and provided instructions for responding. Adding a “Sequence Listing XML” where one was not previously filed must conform with the requirements of 37 CFR 1.835(a). See MPEP § 2414.02 for details. To amend a “Sequence Listing XML” due to errors or omissions, the procedure is outlined in 37 CFR 1.835(b). See MPEP § 2414.03 for details.

Jump to MPEP Source · 37 CFR 1.835(a)Sequence Listing FormatSequence Listing RequirementsSequence Listing Content
StatutoryInformativeAlways
[mpep-2414-01-918b79737124a3e9b081e04e]
Amendment Procedure for Sequence Listing XML
Note:
The procedure to amend a 'Sequence Listing XML' due to errors or omissions is outlined in 37 CFR 1.835(b).

Initial review by the pre-examination staff at the USPTO checks for compliance with formal matters. In order to ensure that an application is ready for examination, pre-examination staff check that applications containing disclosures of nucleotides and/or amino acid sequences have complied with the sequence listing rules. This means that for applications having a filing date on or after July 1, 2022, containing such sequence disclosures, a “Sequence Listing XML” must be of record and if not, applicant will be notified of such deficiency and provided instructions for responding. Adding a “Sequence Listing XML” where one was not previously filed must conform with the requirements of 37 CFR 1.835(a). See MPEP § 2414.02 for details. To amend a “Sequence Listing XML” due to errors or omissions, the procedure is outlined in 37 CFR 1.835(b). See MPEP § 2414.03 for details.

Jump to MPEP Source · 37 CFR 1.835(a)Sequence Listing FormatSequence Listing RequirementsSequence Listing Content

Citations

Primary topicCitation
Sequence Listing Content37 CFR § 1.831(b)
Sequence Listing Content
Sequence Listing Format
37 CFR § 1.835(a)
Sequence Listing Content
Sequence Listing Format
37 CFR § 1.835(b)
Sequence Listing Content
Sequence Listing Format
MPEP § 2414.02
Sequence Listing Content
Sequence Listing Format
MPEP § 2414.03

Source Text from USPTO’s MPEP

This is an exact copy of the MPEP from the USPTO. It is here for your reference to see the section in context.

BlueIron Last Updated: 2025-12-31