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

This page is an FAQ based on guidance from the Manual of Patent Examining Procedure. It is provided as guidance, with links to the ground truth sources. This is information only: it is not legal advice.

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.”