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Question:
When is a Sequence Listing XML required?
Answer:
When an application filed under 35 U.S.C. 111(a) having a filing date on or after July 1, 2022, or an application which entered the national stage, having an international filing date on or after July 1, 2022, contains disclosure of nucleotide and/or amino acid sequences, a “Sequence Listing XML” is required.
Chapter Details:
The answer to this question can be found in chapter 2400 of the MPEP. This chapter covers Biotechnology.
The answer is from the 9th Edition, Revision 01.2024, Published November 2024. Depending on future changes to the MPEP, the question and answer may or may not be applicable in later Editions or revisions.
Section Summary:
This question and answer comes from section 2414 of the MPEP. The following is a brief summary of section 2414.
2414 Notification of a Failure to Comply with Sequence Listing Requirements and Amendments Relating to “Sequence Listing XML” Files Under 37
For applications filed on or after July 1, 2022, containing nucleotide or amino acid sequences, a compliant “Sequence Listing XML” is mandatory. If missing or defective, pre-examination staff will notify applicants to submit or replace it to meet compliance with 37 C.F.R. 1.831 – 1.835. Examiners may also require a replacement if sequences in the disclosure are not included in the submitted “Sequence Listing XML.”