What sequences must be included in the “Sequence Listing” of a patent application?

According to MPEP 2422.01, the following sequences must be included in the “Sequence Listing” of a patent application:

1. All sequences, whether claimed or not, that meet the length thresholds in 37 CFR 1.821(a).
2. Any sequence disclosed as a string of particular nucleotide bases or amino acids, regardless of whether the applicant considers it prior art.
3. Sequences that are essential material, even if they are only referred to by name and a publication or accession reference.

The MPEP states: “All sequences, whether claimed or not, that meet the length thresholds in 37 CFR 1.821(a) are subject to the “Sequence Listing” rules.” It further clarifies: “In general, any sequence that is disclosed and/or claimed as a sequence, i.e., as a string of particular nucleotide bases or amino acids, and that otherwise meets the criteria of 37 CFR 1.821(a), must be set forth in the “Sequence Listing”.“

The goal is to build a comprehensive database for assessing prior art. Therefore, it’s essential that all qualifying sequences, whether only disclosed or also claimed, be included in the database.

However, prior art sequences that are only referred to by name and a publication or accession reference need not be included, unless they are considered “essential material” as per MPEP § 608.01(p).

To learn more:

• Sequence Listing
• patent applications
• nucleotide sequences
• amino acid sequences
• essential material