37 C.F.R. §§ 1.832–1.834

3 sections in range

§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]

37 C.F.R. §§ 1.832–1.834

§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.

Amendments

Source

Authority

Source

Amendments

§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.

Amendments

Source

Authority

Source

Amendments

§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.

Amendments

Source

Authority

Source

Amendments

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