37 CFR § 1.832 — Representation of nucleotide and/or (MPEP Coverage Index) – BlueIron IP
37 CFR § 1.832 Representation of nucleotide and/or
Source: Patent Rule (37 CFR)BlueIron Update:
This page consolidates MPEP guidance interpreting 37 CFR § 1.832, including 104 rules from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.
Summary
The Representation of nucleotide and/or amino acid sequences in sequence listings must include all relevant sequences, adhere to specific formatting requirements, and ensure accuracy.
What this section covers
- Define what this section covers at a high level, including both nucleotide and amino acid sequences.
- Identify the core topic and scope of guidance in this section, focusing on sequence listing requirements.
Key obligations
- State the primary requirement practitioners must satisfy, ensuring all relevant sequences are included in the listing.
- State an additional required element or condition, such as specifying sequence length and format.
- State a key compliance obligation tied to authority (USC/CFR), ensuring all required sequences are accurately and completely listed.
Practice notes
- Give a practical drafting or filing tip grounded in this section, such as ensuring all relevant sequences are included and formatted correctly.
- Call out a common pitfall or best practice, such as avoiding omissions in sequence listings that could lead to prosecution issues.
Official MPEP § 1.832 — Representation of nucleotide and/or
Source: USPTOLast Modified: 10/30/2024 08:50:22
1.832 Representation of nucleotide and/or amino acid sequence data in the “Sequence Listing XML” part of a patent application filed on or after July 1, 2022.
- (a) Each disclosed nucleotide or amino acid sequence that meets the requirements of § 1.831(b) must appear separately in the “Sequence Listing XML.” Each sequence set forth in the “Sequence Listing XML” must be assigned a separate sequence identifier. The sequence identifiers must begin with 1 and increase sequentially by integers as defined in paragraph 10 of WIPO Standard ST.26 (incorporated by reference, see § 1.839 ).
- (b) The representation and symbols for
nucleotide sequence data shall conform to the requirements of
paragraphs (b)(1) through (4) of this section.
- (1) A nucleotide sequence must be represented in the manner described in paragraphs 11–12 of WIPO Standard ST.26.
- (2) All nucleotides, including nucleotide analogs, modified nucleotides, and “unknown” nucleotides, within a nucleotide sequence must be represented using the symbols set forth in paragraphs 13–16, 19, and 21 of WIPO Standard ST.26.
- (3) Modified nucleotides within a nucleotide sequence must be described in the manner discussed in paragraphs 17, 18, and 19 of WIPO Standard ST.26.
- (4) A region containing a known number of contiguous “a,” “c,” “g,” “t,” or “n” residues for which the same description applies may be jointly described in the manner described in paragraph 22 of WIPO Standard ST.26.
- (c) The representation and symbols for
amino acid sequence data shall conform to the requirements of
paragraphs (c)(1) through (4) of this section.
- (1) The amino acids in an amino acid sequence must be represented in the manner described in paragraphs 24 and 25 of WIPO Standard ST.26.
- (2) All amino acids, including modified amino acids and “unknown” amino acids, within an amino acid sequence must be represented using the symbols set forth in paragraphs 26–29 and 32 of WIPO Standard ST.26.
- (3) Modified amino acids within an amino acid sequence must be described in the manner discussed in paragraphs 29 and 30 of WIPO Standard ST.26.
- (4) A region containing a known number of contiguous “X” residues for which the same description applies may be jointly described in the manner described in paragraph 34 of WIPO Standard ST.26.
- (d) A nucleotide and/or amino acid sequence that is constructed as a single continuous sequence derived from one or more non-contiguous segments of a larger sequence or of segments from different sequences must be listed in the “Sequence Listing XML” in the manner described in paragraph 35 of WIPO Standard ST.26.
- (e) A nucleotide and/or amino acid sequence that contains regions of specifically defined residues separated by one or more regions of contiguous “n” or “X” residues, wherein the exact number of “n” or “X” residues in each region is disclosed, must be listed in the “Sequence Listing XML” in the manner described in paragraph 36 of WIPO Standard ST.26.
- (f) A nucleotide and/or amino acid sequence that contains regions of specifically defined residues separated by one or more gaps of an unknown or undisclosed number of residues must be listed in the “Sequence Listing XML” in the manner described in paragraph 37 of WIPO Standard ST.26.
[Added 87 FR 30806, May, 20, 2022, effective July 1, 2022]