What are the requirements for submitting a “Sequence Listing XML” in patent applications?

According to MPEP 2416, patent applications filed on or after July 1, 2022, that contain disclosures of nucleotide and/or amino acid sequences must include a “Sequence Listing XML” as a separate part of the disclosure. This XML file must be submitted in one of two ways:

  • Via the USPTO’s patent electronic filing system (Patent Center) in XML format, with an incorporation by reference statement in the specification.
  • On read-only optical disc(s) labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement in the specification.

The incorporation by reference statement must include:

  • The name of the XML file
  • The date of creation
  • The size of the XML file in bytes

As stated in 37 CFR 1.831(a), “patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831 – 1.835.”

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Topics: MPEP 2400 - Biotechnology, MPEP 2416 - Form Paragraphs, Patent Law, Patent Procedure
Tags: amino acid sequences, nucleotide sequences, patent applications, sequence listing xml, USPTO