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Notes

37 C.F.R. §§ 1.831–1.834

4 sections in range

§1.831. Requirements for patent applications filed on or after July 1, 2022, having nucleotide and/or amino acid sequence disclosures.

37 C.F.R. § 1.831

(a)
Patent applications disclosing a nucleotide and/or amino acid sequence(s) by enumeration of its residues, as defined in paragraph (b) of this section, must contain, as a separate part of the disclosure, a computer readable Sequence Listing in XML format (a “Sequence Listing XML”). Disclosed nucleotide or amino acid sequences that do not meet the definition in paragraph (b) of this section must not be included in the “Sequence Listing XML.” The “Sequence Listing XML” contains the information of the nucleotide and/or amino acid sequence(s) disclosed in the patent application using the symbols and format in accordance with the requirements of §§ 1.832 through 1.834.
(b)
Nucleotide and/or amino acid sequences, as used in this section and §§ 1.832 through 1.835, encompass:
(1)
An unbranched sequence or linear region of a branched sequence containing 4 or more specifically defined amino acids, wherein the amino acids form a single peptide backbone; or
(2)
An unbranched sequence or linear region of a branched sequence of 10 or more specifically defined nucleotides, wherein adjacent nucleotides are joined by:
(i)
A 3′ to 5′ (or 5′ to 3′) phosphodiester linkage; or
(ii)
Any chemical bond that results in an arrangement of adjacent nucleobases that mimics the arrangement of nucleobases in naturally occurring nucleic acids (i.e., nucleotide analogs).
(c)
Where the description or claims of a patent application discuss a sequence that is set forth in the “Sequence Listing XML” in accordance with paragraph (a) of this section, reference must be 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, even if the sequence is also embedded in the text of the description or claims of the patent application. Where a sequence is presented in a drawing, reference must be made to the sequence by use of the sequence identifier (§ 1.832(a)), either in the drawing or in the Brief Description of the Drawings, where the correlation between multiple sequences in the drawing and their sequence identifiers (§ 1.832(a)) in the Brief Description is clear.
(d)
“Enumeration of its residues” means disclosure of a nucleotide or amino acid sequence in a patent application by listing, in order, each residue of the sequence, where the residues are represented in the manner as defined in paragraph 3(c)(i) or (ii) of WIPO Standard ST.26 (incorporated by reference, see § 1.839).
(e)
“Specifically defined” means any amino acid or nucleotide as defined in paragraph 3(k) of WIPO Standard ST.26.
(f)
“Amino acid” includes any D- or L-amino acid or modified amino acid as defined in paragraph 3(a) of WIPO Standard ST.26.
(g)
“Modified amino acid” includes any amino acid as described in paragraph 3(e) of WIPO Standard ST.26.
(h)
“Nucleotide” includes any nucleotide, nucleotide analog, or modified nucleotide as defined in paragraphs 3(f) and 3(g) of WIPO Standard ST.26.
(i)
“Modified nucleotide” includes any nucleotide as described in paragraph 3(f) of WIPO Standard ST.26.
(j)
A “Sequence listing XML” must not include any sequences having fewer than 10 specifically defined nucleotides, or fewer than 4 specifically defined amino acids.
Notes, amendments, and revision history

Amendments

[87 FR 30818, May 20, 2022, as amended at 88 FR 34091, May 26, 2023]

Source

Source: Sections 1.821 through 1.825 appear at 55 FR 18245, May 1, 1990, unless otherwise noted.

Authority

Authority: 35 U.S.C. 2(b)(2), unless otherwise noted.

Source

Source: 24 FR 10332, Dec. 22, 1959, unless otherwise noted.

Amendments

[87 FR 30818, May 20, 2022, as amended at 88 FR 34091, May 26, 2023]

§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.

37 C.F.R. § 1.832

(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.
Notes, amendments, and revision history

Amendments

[87 FR 30818, May 20, 2022]

Source

Source: Sections 1.821 through 1.825 appear at 55 FR 18245, May 1, 1990, unless otherwise noted.

Authority

Authority: 35 U.S.C. 2(b)(2), unless otherwise noted.

Source

Source: 24 FR 10332, Dec. 22, 1959, unless otherwise noted.

Amendments

[87 FR 30818, May 20, 2022]

§1.833. Requirements for a “Sequence Listing XML” for nucleotide and/or amino acid sequences as part of a patent application filed on or after July 1, 2022.

37 C.F.R. § 1.833

(a)
The “Sequence Listing XML” as required by § 1.831(a) must be presented as a single file in XML 1.0 encoded using Unicode UTF-8, where the character set complies with paragraphs 40 and 41 and Annex IV of WIPO Standard ST.26 (incorporated by reference, see § 1.839).
(b)
The “Sequence Listing XML” presented in accordance with paragraph (a) of this section must further:
(1)
Be valid according to the Document Type Definition (DTD) as presented in WIPO Standard ST.26, Annex II.
(2)
Comply with the requirements of WIPO Standard ST.26 to include:
(i)
An XML declaration as defined in paragraph 39(a) of WIPO Standard ST.26;
(ii)
A document type (DOCTYPE) declaration as defined in paragraph 39(b) of WIPO Standard ST.26;
(iii)
A root element as defined in paragraph 43 of WIPO Standard ST.26;
(iv)
A general information part that complies with the requirements of paragraphs 45, 47, and 48, as applicable, of WIPO Standard ST.26; and
(v)
A sequence data part that complies with the requirements of paragraphs 50-55, 57, 58, 60-69, 71-78, 80-87, 89-98, and 100, as applicable, of WIPO Standard ST.26 representing the nucleotide and/or amino acid sequences according to § 1.832.
(3)
Include an INSDQualifier__value element with a value in English for any language-dependent free text qualifier as defined by paragraphs 76 and 85-87 of WIPO Standard ST.26, and as required by § 1.52(b)(1)(ii).
Notes, amendments, and revision history

Amendments

[87 FR 30818, May 20, 2022]

Source

Source: Sections 1.821 through 1.825 appear at 55 FR 18245, May 1, 1990, unless otherwise noted.

Authority

Authority: 35 U.S.C. 2(b)(2), unless otherwise noted.

Source

Source: 24 FR 10332, Dec. 22, 1959, unless otherwise noted.

Amendments

[87 FR 30818, May 20, 2022]

§1.834. Form and format for nucleotide and/or amino acid sequence submissions as the “Sequence Listing XML” in patent applications filed on or after July 1, 2022.

37 C.F.R. § 1.834

(a)
A “Sequence Listing XML” encoded using Unicode UTF-8, created by any means (e.g., text editors, nucleotide/amino acid sequence editors, or other custom computer programs) in accordance with §§ 1.831 through 1.833, must:
(1)
Have the following compatibilities—
(i)
Computer compatibility— PC or Mac®; and
(ii)
Operating system compatibility— MS-DOS®, MS-Windows®, Mac OS®, or Unix®/Linux®.
(2)
Be in XML format, where all permitted printable characters (including the space character) and non-printable (control) characters are defined in paragraph 40 of WIPO Standard ST.26 (incorporated by reference, see § 1.839).
(3)
Be named as .xml, where “” is one character or a combination of characters limited to upper- or lowercase letters, numbers, hyphens, and underscores, and the name does not exceed 60 characters in total, excluding the extension. No spaces or other types of characters are permitted in the file name.
(b)
The “Sequence Listing XML” must be in a single file containing the sequence information and be submitted either:
(1)
Electronically via the USPTO patent electronic filing system, where the file size must not exceed 100 MB, and file compression is not permitted; or
(2)
On read-only optical disc(s) in compliance with § 1.52(e), where:
(i)
A file that is not compressed must be contained on a single read-only optical disc;
(ii)
The file may be compressed using WinZip®, 7-Zip, or Unix®/Linux® Zip;
(iii)
A compressed file must not be self-extracting; or
(iv)
A compressed XML file that does not fit on a single read-only optical disc may be split into multiple file parts, in accordance with the target read-only optical disc size, and labeled in compliance with § 1.52(e)(5)(vi);
(c)
(1)
Unless paragraph (c)(2) of this section applies, when the “Sequence Listing XML” required by § 1.831(a) is submitted in XML file format via the USPTO patent electronic filing system or on a read-only optical disc (in compliance with § 1.52(e)), then the specification must contain a statement in a separate paragraph (see § 1.77(b)(5)) that incorporates by reference the material in the XML file identifying:
(i)
The name of the file;
(ii)
The date of creation; and
(iii)
The size of the file in bytes; or
(2)
If the “Sequence Listing XML” required by § 1.831(a) is submitted in XML file format via the USPTO patent electronic filing system or on a read-only optical disc (in compliance with § 1.52(e)) for an international application during the international stage, then an incorporation by reference statement of the material in the XML file is not required.
Notes, amendments, and revision history

Amendments

[87 FR 30818, May 20, 2022]

Source

Source: Sections 1.821 through 1.825 appear at 55 FR 18245, May 1, 1990, unless otherwise noted.

Authority

Authority: 35 U.S.C. 2(b)(2), unless otherwise noted.

Source

Source: 24 FR 10332, Dec. 22, 1959, unless otherwise noted.

Amendments

[87 FR 30818, May 20, 2022]