What is the requirement for submitting a separate computer readable form (CRF) of a “Sequence Listing”?

When a separate computer readable form (CRF) of a “Sequence Listing” is submitted in certain patent applications, a statement regarding the information contained in the “Sequence Listing” and the separate CRF is required. Specifically:

• For applications filed under 35 U.S.C. 111(a) or national stage applications submitted under 35 U.S.C. 371, where the “Sequence Listing” is filed as a PDF image file or on physical sheets of paper, 37 CFR 1.821(e)(1)(ii) and (2)(ii) require “a statement that the information contained in the ‘Sequence Listing’ and the separate CRF are identical.”
• For international applications, 37 CFR 1.821(e)(3)(iii) requires “a statement that the information contained in the CRF does not go beyond the disclosure in the international application as filed or a statement that the information recorded in the ASCII plain text file of the CRF is identical to the sequence listing contained in the international application as filed, as applicable.”

It’s important to note that these requirements are not applicable to applications filed on or after July 1, 2022, which have disclosures of nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b).

To learn more:

• Sequence Listing
• CRF
• Patent Application
• USPTO
• Biotechnology Patents