MPEP § 2412.01 — Overview of the Sequence Rules (Annotated Rules)
§2412.01 Overview of the Sequence Rules
This page consolidates and annotates all enforceable requirements under MPEP § 2412.01, 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.
Overview of the Sequence Rules
This section addresses Overview of the Sequence Rules. Primary authority: 37 CFR 1.831 and 37 CFR 1.831(a). Contains: 2 requirements.
Key Rules
Sequence Listing Content
[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).]
Under the sequence listing rules, 37 CFR 1.831 – 1.834, an application having a filing date on or after July 1, 2022, that discloses one or more nucleotide and/or amino acid sequences by enumeration of its residues, as defined in 37 CFR 1.831(a), must contain, as a part of the description, a sequence listing in eXtensible Markup Language (XML) format, where the XML file of the sequence information conforms to the requirements of 37 CFR 1.831 – 1.834, which specify requirements of particular paragraphs of WIPO Standard ST.26. For U.S. applications, the sequence rules do not require that all sequences and associated sequence information contained in the required sequence listing part of the description be disclosed elsewhere in the application; the content of a sequence listing is considered part of the disclosure of the invention. However, for international applications, all sequences and associated sequence information contained in the required sequence listing part of the description is considered an application part if present on the filing date without an incorporation by reference.
Sequence Listing Format
Under the sequence listing rules, 37 CFR 1.831 – 1.834, an application having a filing date on or after July 1, 2022, that discloses one or more nucleotide and/or amino acid sequences by enumeration of its residues, as defined in 37 CFR 1.831(a), must contain, as a part of the description, a sequence listing in eXtensible Markup Language (XML) format, where the XML file of the sequence information conforms to the requirements of 37 CFR 1.831 – 1.834, which specify requirements of particular paragraphs of WIPO Standard ST.26. For U.S. applications, the sequence rules do not require that all sequences and associated sequence information contained in the required sequence listing part of the description be disclosed elsewhere in the application; the content of a sequence listing is considered part of the disclosure of the invention. However, for international applications, all sequences and associated sequence information contained in the required sequence listing part of the description is considered an application part if present on the filing date without an incorporation by reference.
Citations
| Primary topic | Citation |
|---|---|
| Sequence Listing Content Sequence Listing Format | 37 CFR § 1.831 |
| Sequence Listing Content Sequence Listing Format | 37 CFR § 1.831(a) |
| Sequence Listing Content | 37 CFR § 1.831(b) |
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.
Official MPEP § 2412.01 — Overview of the Sequence Rules
Source: USPTO2412.01 Overview of the Sequence Rules [R-01.2024]
[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).]
Under the sequence listing rules, 37 CFR 1.831 – 1.834, an application having a filing date on or after July 1, 2022, that discloses one or more nucleotide and/or amino acid sequences by enumeration of its residues, as defined in 37 CFR 1.831(a), must contain, as a part of the description, a sequence listing in eXtensible Markup Language (XML) format, where the XML file of the sequence information conforms to the requirements of 37 CFR 1.831 – 1.834, which specify requirements of particular paragraphs of WIPO Standard ST.26. For U.S. applications, the sequence rules do not require that all sequences and associated sequence information contained in the required sequence listing part of the description be disclosed elsewhere in the application; the content of a sequence listing is considered part of the disclosure of the invention. However, for international applications, all sequences and associated sequence information contained in the required sequence listing part of the description is considered an application part if present on the filing date without an incorporation by reference.