37 CFR 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

Ninth Edition, Revision 01.2024

  • (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 nonprintable (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.

[Added 87 FR 30806, May, 20, 2022, effective July 1, 2022]

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