Are there exceptions to the requirement for submitting a separate CRF and statement?

Yes, there are exceptions to the requirement for submitting a separate Computer Readable Form (CRF) and the associated statement. According to MPEP 2422.06:

“Note that, in an application filed under 35 U.S.C. 111(a), if a ‘Sequence Listing’ is filed as an ASCII plain text file via the USPTO patent electronic filing system or on a read-only optical disc under 37 CFR 1.52(e), and applicant has not filed a ‘Sequence Listing’ as a PDF image file or on physical sheets of paper, the ASCII plain text file will serve as both the ‘Sequence Listing’ required by 37 CFR 1.821(c) and the computer readable form (CRF) required by 37 CFR 1.821(e).”

The same exception applies to national stage applications submitted under 35 U.S.C. 371.

In these cases, the following are not required and should not be submitted:

  1. A second copy of the “Sequence Listing” as a PDF image file or on physical sheets of paper
  2. A statement under 37 CFR 1.821(e)(1)(ii) or (2)(ii) indicating that the sequence information in the “Sequence Listing” and CRF copy are identical

This exception simplifies the submission process for applicants who file the “Sequence Listing” in the specified ASCII plain text format.

To learn more:

Topics: MPEP 2400 - Biotechnology, MPEP 2422.06 - Requirement For Statement Regarding Information Contained In The "Sequence Listing" And Separate Computer Readable Form, Patent Law, Patent Procedure
Tags: ascii plain text, biotechnology patents, Crf, sequence listing, USPTO