2422.04 The Requirement for a Computer Readable Copy of the Official Copy of the Sequence Listing [R-07.2015]

37 CFR 1.821(e) requires the submission of a copy of the sequence listing in computer readable form. The computer readable form may be submitted on the electronic media permitted by 37 CFR 1.824, or may be submitted as an ASCII text file via EFS-Web. The information on the computer readable form will be entered into the Office’s database for searching and printing nucleotide and amino acid sequences. This electronic database will also enable the Office to provide published sequence data, in electronic form, to the National Center for Biotechnology Information (NCBI) for publication in GenBank, and enable NCBI to exchange data with the DNA Data Bank of Japan (DDBJ) and the European Bioinformatics Institute (EBI). It should be noted that the Office’s database complies with the confidentiality requirement imposed by 35 U.S.C. 122. Unpublished pending application sequences are maintained in the database separately from published or patented sequences. That is, the Office will not exchange or make public any information on any sequence until the patent application containing that information is published or matures into a patent, or as otherwise allowed by 35 U.S.C. 122.

The Office may permit correction of the official copy of the sequence listing submitted pursuant to 37 CFR 1.821(c), whether on paper or compact disc, at the least, during the pendency of a given application by reference to the computer readable copy thereof submitted pursuant to 37 CFR 1.821(e) if both the official copy and computer readable form were submitted at the time of filing of the application and the totality of the circumstances otherwise substantiate the proposed correction. A mere discrepancy between the official copy and the computer readable form may not, in and of itself, be sufficient to justify a proposed correction. In this regard, the Office will assume that the computer readable form has been incorporated by reference into the application when the official copy and computer readable form were submitted at the time of filing of the application. The Office will attempt to accommodate or address all correction issues, but it must be kept in mind that the real burden rests with the applicant to ensure that any discrepancies between the official copy and the computer readable form are eliminated or minimized. Applicants should be aware that there will be instances where the applicant may have to suffer the consequences of any discrepancies between the two. If a new application is filed via EFS-Web with an ASCII text file sequence listing that complies with the requirements of 37 CFR 1.824(a)(2)(6) and 37 CFR 1.824(b), and applicant has not filed a sequence listing in a PDF file, the text file will serve as both the paper copy required by 37 CFR 1.821(c) and CRF required by 37 CFR 1.821(e), eliminating any chance for discrepancies between the official copy and the CRF.

The Office does not desire to be bound by a requirement to permanently preserve computer readable forms for support, priority or correction purposes. For example, the Office will make corrections, where appropriate, by reference to the CRF as long as the CRF is still available to the Office. However, once use of the CRF by the Office for processing has ended, i.e., once the Office has entered the data contained on the computer readable form into the appropriate database, the Office does not intend to further preserve the CRF submitted by the applicant.