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Notes

37 C.F.R. §§ 1.822–1.824

3 sections in range

§1.822. Symbols and format to be used for nucleotide and/or amino acid sequence data.

37 C.F.R. § 1.822

(a)
The symbols and format to be used for nucleotide and/or amino acid sequence data shall conform to the requirements of paragraphs (b) through (e) of this section.
(b)
The code for representing the nucleotide and/or amino acid sequence characters shall conform to the code set forth in appendices A and C to this subpart. No code other than that specified in these sections shall be used in nucleotide and amino acid sequences. A modified base or modified or unusual amino acid may be presented in a given sequence as the corresponding unmodified base or amino acid if the modified base or modified or unusual amino acid is one of those listed in appendices B and D to this subpart, and the modification is also set forth in the Feature section. Otherwise, each occurrence of a base or amino acid not appearing in appendices A and C, shall be listed in a given sequence as “n” or “Xaa,” respectively, with further information, as appropriate, given in the Feature section, by including one or more feature keys listed in appendices E and F to this subpart.
(c)
Format representation of nucleotides.
(1)
A nucleotide sequence shall be listed using the lowercase letter for representing the one-letter code for the nucleotide bases set forth in appendix A to this subpart.
(2)
The bases in a nucleotide sequence (including introns) shall be listed in groups of 10 bases except in the coding parts of the sequence. Leftover bases, fewer than 10 in number, at the end of noncoding parts of a sequence shall be grouped together and separated from adjacent groups of 10 or 3 bases by a space.
(3)
The bases in the coding parts of a nucleotide sequence shall be listed as triplets (codons). The amino acids corresponding to the codons in the coding parts of a nucleotide sequence shall be listed immediately below the corresponding codons. Where a codon spans an intron, the amino acid symbol shall be listed below the portion of the codon containing two nucleotides.
(4)
A nucleotide sequence shall be listed with a maximum of 16 codons or 60 bases per line, with a space provided between each codon or group of 10 bases.
(5)
A nucleotide sequence shall be represented, only by a single strand, in the 5 to 3 direction, from left to right.
(6)
The enumeration of nucleotide bases shall start at the first base of the sequence with number 1. The enumeration shall be continuous through the whole sequence in the direction 5 to 3. The enumeration shall appear in the right margin, next to the line containing the one-letter codes for the bases and giving the number of the last base of that line.
(7)
For those nucleotide sequences that are circular in configuration, the enumeration method set forth in paragraph (c)(6) of this section remains applicable with the exception that the designation of the first base of the nucleotide sequence may be made at the option of the applicant.
(d)
Representation of amino acids.
(1)
The amino acids in a protein or peptide sequence shall be listed using the three-letter abbreviation, with the first letter as an uppercase character, as in Appendix C to this subpart.
(2)
A protein or peptide sequence shall be listed with a maximum of 16 amino acids per line, with a space provided between each amino acid.
(3)
An amino acid sequence shall be represented in the amino to carboxy direction, from left to right, and the amino and carboxy groups shall not be represented in the sequence.
(4)
The enumeration of amino acids may start at the first amino acid of the first mature protein, with the number 1. When represented, the amino acids preceding the mature protein (e.g., pre-sequences, pro-sequences, pre-pro-sequences, and signal sequences) shall have negative numbers, counting backwards starting with the amino acid next to number 1. Otherwise, the enumeration of amino acids shall start at the first amino acid at the amino terminal as number 1, and shall appear below every five amino acids of the sequence. The enumeration method for amino acid sequences that is set forth in this section remains applicable for amino acid sequences that are circular in configuration, with the exception that the designation of the first amino acid of the sequence may be made at the option of the applicant.
(5)
An amino acid sequence that contains internal terminator symbols (e.g., “Ter,” “*,” or “.,” etc.) may not be represented as a single amino acid sequence but shall be represented as separate amino acid sequences.
(e)
A sequence with a gap or gaps shall be represented as a plurality of separate sequences, with separate sequence identifiers (§ 1.823(a)(5)), with the number of separate sequences being equal in number to the number of continuous strings of sequence data. A sequence composed of one or more noncontiguous segments of a larger sequence or segments from different sequences shall be presented as a separate sequence.
Notes, amendments, and revision history

Amendments

[63 FR 29635, June 1, 1998, as amended at 69 FR 18803, Apr. 9, 2004; 70 FR 10489, Mar. 4, 2005; 86 FR 57050, Oct. 14, 2021]

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

[63 FR 29635, June 1, 1998, as amended at 69 FR 18803, Apr. 9, 2004; 70 FR 10489, Mar. 4, 2005; 86 FR 57050, Oct. 14, 2021]

§1.823. Requirements for content of a “Sequence Listing” part of the specification.

37 C.F.R. § 1.823

(a)
The “Sequence Listing” must comply with the following:
(1)
The order and presentation of the items of information in the “Sequence Listing” shall conform to the arrangement in appendix G to this subpart. The submission of those items of information designated with an “M” is mandatory. The submission of those items of information designated with an “O” is optional.
(2)
Each item of information shall begin on a new line, with the numeric identifier enclosed in angle brackets, as shown in appendix G to this subpart.
(3)
Set forth numeric identifiers <110> through <170> at the beginning of the “Sequence Listing.”
(4)
Include each disclosed nucleotide and/or amino acid sequence, as defined in § 1.821(a).
(5)
Assign a separate sequence identifier to each sequence, beginning with 1 and increasing sequentially by integers, and include the sequence identifier in numeric identifier <210>.
(6)
Use the code “000” in place of the sequence where no sequence is present for a sequence identifier.
(7)
Include the total number of SEQ ID NOs in numeric identifier <160>, as defined in appendix G to this subpart, whether followed by a sequence or by the code “000.”
(8)
Must not contain more than 74 characters per line.
(b)
(1)
Unless paragraph (b)(2) of this section applies, if the “Sequence Listing” required by § 1.821(c) is submitted as an ASCII plain text file 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 ASCII plain text file identifying:
(i)
The name of the file;
(ii)
The date of creation; and
(iii)
The size of the file in bytes.
(2)
If the “Sequence Listing” required by § 1.821(c) is submitted as an ASCII plain text file 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 incorporation by reference of the material in the ASCII plain text file is not required.
(3)
A “Sequence Listing” required by § 1.821(c) that is submitted as a PDF file (§ 1.821(c)(2)) via the USPTO patent electronic filing system or on physical sheets of paper (§ 1.821(c)(3)), setting forth the nucleotide and/or amino acid sequence and associated information in accordance with paragraph (a) of this section:
(i)
Must begin on a new page;
(ii)
Must be titled “Sequence Listing”;
(iii)
Must not include material other than the “Sequence Listing” itself;
(iv)
Must have sheets containing no more than 66 lines, with each line containing no more than 74 characters;
(v)
Should have sheets numbered independently of the numbering of the remainder of the application; and
(vi)
Should use a fixed-width font exclusively throughout.
Notes, amendments, and revision history

Amendments

[86 FR 57050, Oct. 14, 2021]

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

[86 FR 57050, Oct. 14, 2021]

§1.824. Form and format for a nucleotide and/or amino acid sequence submission as an ASCII plain text file.

37 C.F.R. § 1.824

(a)
A “Sequence Listing” under § 1.821(c)(1) and the CRF required by § 1.821(e) submitted as an ASCII plain text file may be created by any means, such as text editors, nucleotide/amino acid sequence editors, or other custom computer programs; however, the ASCII plain text file must conform to the following requirements:
(1)
Must 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)
Must be in ASCII plain text, where—
(i)
All printable characters (including the space character) are permitted; and
(ii)
No nonprintable (ASCII control) characters are permitted, except ASCII CRLF or LF as line terminators.
(3)
Must be named as .txt, where “” is one character or a combination of characters limited to upper- or lowercase letters, numbers, hyphens, and underscores and does not exceed 60 characters in total, excluding the extension. No spaces or other types of characters are permitted in the file name.
(4)
Must contain no more than 74 printable characters in each line.
(5)
Pagination is not permitted; the ASCII plain text file must be one continuous file, with no “hard page break” codes and no page numbering.
(b)
The ASCII plain text file must contain a copy of a single “Sequence Listing” in a single file and be submitted either:
(1)
Electronically via the USPTO patent electronic filing system, where the file must not exceed 100 MB, and file compression is not permitted; or
(2)
On a 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; and
(iv)
A compressed ASCII plain text 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).
Notes, amendments, and revision history

Amendments

[86 FR 57051, Oct. 14, 2021]

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

[86 FR 57051, Oct. 14, 2021]