37 CFR 1.821(c) requires that applications containing disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) contain, as a separate part of the disclosure, a disclosure of the nucleotide and/or amino acid sequences, and associated information, using the format and symbols that are set forth in 37 CFR 1.822 and 37 CFR 1.823. This separate part of the disclosure is referred to as the sequence listing. The sequence listing required pursuant to 37 CFR 1.821(c) may be submitted as an ASCII text file via EFS-Web, on compact disc, as a PDF submitted via EFS-Web, or on paper. The sequence listing required by 37 CFR 1.821(c) is the official copy of the sequence listing. If submitted on paper, the sequence listing is a separate part of the disclosure which must begin on a new page within the specification. A plurality of sequences may, if feasible, be presented on a single page; the separate presentation of both nucleotide and amino acid sequences on the same page is also permitted. Note that 37 CFR 1.821(e) requires that a copy of the sequence listing referred to in 37 CFR 1.821(c) must also be submitted in computer readable form (CRF) in accordance with the requirements of 37 CFR 1.824.
If the “Sequence Listing” required by 37 CFR 1.821(c) was submitted in ASCII text format in an international application, indicated on the Request as part of the international application, and published as part of the international application for which national stage is entered under 35 U.S.C. 371, then no further submission or incorporation by reference into the specification is required.
I. ASCII TEXT FILE SUBMITTED VIA EFS-WEB
The Office strongly suggests filing the sequence listing required by 37 CFR 1.821(c) as a text file via EFS-Web. 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 (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 the computer readable form (CRF) required by 37 CFR 1.821(e). Note that the specification must contain a statement in a separate paragraph that incorporates by reference the material in the ASCII text file identifying the name of the ASCII text file, the date of creation, and the size of the ASCII text file in bytes. See MPEP § 2422.03(a) for additional information pertaining to EFS-Web submission of sequence listings.
II. ASCII TEXT FILE ON COMPACT DISC
If the official copy of the sequence listing as required by 37 CFR 1.821(c) is submitted on compact disc, the specification must contain an incorporation by reference of the material on the compact disc in a separate paragraph, identifying each compact disc by the names of the file(s) contained on each of the compact discs, their date of creation and their sizes in bytes (37 CFR 1.52(e)). The total number of compact discs including duplicates and the files on each compact disc shall be specified (37 CFR 1.77(b)(5)).
The compact disc used to submit the sequence listing may also contain table information if the table has more than 50 pages of text. See 37 CFR 1.823(a)(2) and 1.52(e)(1)(iii). The compact disc and duplicate copy must be labeled “Copy 1” and “Copy 2,” respectively, and a statement stating that the copies are identical must be included. If the two compact discs are not identical, the Office will use the disc labeled “Copy 1” for further processing (37 CFR 1.52(e)(4)). See also MPEP § 608.05.
If the sequence listing under 37 CFR 1.821(c) is submitted on compact disc, applicant is still required to submit a separate CRF of the sequence listing pursuant to 37 CFR 1.821(e) and 37 CFR 1.824. If the CRF is also submitted on compact disc, applicants will need to submit a total of three copies of the sequence listing (one pursuant to 37 CFR 1.821(c), and two pursuant to 37 CFR 1.821(e)). The compact disc with the CRF of the sequence listing may be identical to the compact disc submitted under 37 CFR 1.821(c) if the latter compact disc includes only the sequence listing (i.e., no additional content, such as tables).
A.Text Files Up to 300 MB
The sequence listing must be a single document, but the document may be split amongst two or more compact discs using software designed to divide a file that is too large to fit on a single compact disc into multiple concatenated files. If the user breaks up a sequence listing so that it may be submitted on multiple compact discs, the compact discs must be labeled to indicate their order (e.g., “1 of X”, “2 of X”).
One hundred (100) megabytes is the size limit for sequence listing text files submitted via EFS-Web. If a user wishes to submit an electronic copy of a sequence listing text file that exceeds 100 megabytes, the sequence listing must be filed on compact disc(s).
B.Text Files 300 MB or Over
Effective for submissions filed on or after January 16, 2018, the Office set two new fees to manage handling of sequence listings of 300 MB or more in 37 CFR 1.21(o). Pricing for this fee is divided into two tiers with Tier 1 for file sizes 300 MB to 800 MB and Tier 2 for file sizes greater than 800 MB. The level of effort associated with the handling of mega-sequence listings is significant, because the Office’s systems require extra storage and special handling for files beyond 300 MB. The fee should encourage applicants to draft their specifications such that sequence data that is not essential material is not required to be included in a sequence listing. A reduced number of mega-sequence listings will benefit the Office and the public by reducing the strain on Office resources, thus facilitating the effective administration of the patent system.
The fee under 37 CFR 1.21(o) is due upon the first submission of a sequence listing that exceeds 800 MB, or the first submission of a sequence listing of at least 300MB, whichever applicable fee is higher. As an example, if an application was filed prior to January 16, 2018 (with or without a text file sequence listing), and thereafter a mega-sequence listing that is between 300 and 800 MB is filed, the fee under 37 CFR 1.21(o)(1) is due. If an applicant thereafter files a corrected sequence listing that is also between 300 and 800 MB, no additional fee is due. If a further corrected sequence listing is filed and the file size exceeds 800 MB, then the total fee owed under 37 CFR 1.21(o) is the fee set forth in 37 CFR 1.21(o)(2). The fee is due upon submission of the mega-sequence listing. Subsequent deletion or reduction in size of a sequence listing does not change the requirement to pay the mega-sequence listing submission fee.
The fee under 37 CFR 1.21(o) does not apply to international applications, but does apply to the submission of mega-sequence listings received in national stage applications under 35 U.S.C. 371, including mega-sequence listings received by the Office pursuant to PCT Article 20. See MPEP § 2422.03(a), subsection IV, for additional information.