2422.03 Sequence Listing Submission [R-07.2022]

[Editor Note: This section is not applicable to applications filed on or after July 1, 2022, having disclosures of nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b). See MPEP §§ 2412–2419 for guidance on WIPO ST.26 requirements for applications filed on or after July 1, 2022.]

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 specification, a disclosure of each 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 specification is referred to as the “Sequence Listing”. Except for submission of a national phase application under 35 U.S.C. 371 of an international application (PCT) that is compliant with PCT Rule 5.2(a), the “Sequence Listing” required pursuant to 37 CFR 1.821(c) must be submitted (1) 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), accompanied by an incorporation by reference statement of the ASCII plain text file, in a separate paragraph of the specification, in accordance with 37 CFR 1.77(b)(5) (see 37 CFR 1.821(c)(1)); (2) as a PDF image file submitted via the USPTO patent electronic filing system (see 37 CFR 1.821(c)(2)); or (3) on physical sheets of paper (see 37 CFR 1.821(c)(3)). If the “Sequence Listing” required by 37 CFR 1.821(c) is submitted on physical sheets of paper or as a PDF image file, the “Sequence Listing” is a separate part of the specification which must begin on a new page within the specification. Also, in an application filed under 35 U.S.C. 111(a) in which sequence information is submitted in an ASCII plain text file in compliance with 37 CFR 1.824 and as a PDF image file or on physical sheets of paper, the PDF image file or the physical sheets of paper will comply with the listing requirement under 37 CFR 1.821(c) and the ASCII plain text file will comply with the CRF requirement under 37 CFR 1.821(e)(1)(i).

When the “Sequence Listing” is submitted as a PDF image file under 37 CFR 1.821(c)(2) via USPTO patent electronic filing system or on physical sheets of paper under 37 CFR 1.821(c)(3), 37 CFR 1.821(e)(1) requires that the copy of the 1.821(c) “Sequence Listing” must also be submitted in a separate computer readable form (CRF) in accordance with the requirements of 37 CFR 1.824. Similarly, in the case of a national stage application submitted under 35 U.S.C. 371, when the “Sequence Listing” is submitted as a PDF image file via the USPTO patent electronic filing system under 37 CFR 1.821(c)(2) or on physical sheets of paper under 37 CFR 1.821(c)(3), 37 CFR 1.821(e)(2) requires that the copy of the “Sequence Listing” referred to in 37 CFR 1.821(c) must also be submitted in a separate CRF in accordance with the requirements of 37 CFR 1.824. 37 CFR 1.821(e)(3) requires that, in text format in an international application under the PCT that is to be searched by the United States International Searching Authority or examined by the United States International Preliminary Examining Authority, a CRF in accordance with the requirements of 37 CFR 1.824 must be submitted if a “Sequence Listing” in ASCII plain text format in compliance with 37 CFR 1.824 has not been submitted and the application contains disclosures of nucleotide and/or amino acid sequences, as defined in 37 CFR 1.821(a).

At entry into the national stage under 35 U.S.C. 371, an international application compliant with PCT Rule 5.2 that contains a “Sequence Listing” in ASCII plain text format as part of the description satisfies the requirements of 37 CFR 1.821(c) and 37 CFR 1.821(e). If the international application was previously communicated by the International Bureau under PCT Article 20 and/or was originally filed in the United States Patent and Trademark Office, then no further submission of a “Sequence Listing” or incorporation by reference into the specification is required. Alternatively, if applicant must provide a copy of the international application as required by 37 CFR 1.495(b)(1), the copy of the international application must include the “Sequence Listing” part of the application, and no incorporation by reference into the specification is required. See also 37 CFR 1.823(b)(2) and 1.825(c).

Whether submitted via the USPTO patent electronic filing system or on read-only optical disc(s), the ASCII plain text file must contain a copy of a single “Sequence Listing” in a single file. One hundred (100) megabytes is the size limit for “Sequence Listing” and CRF text files submitted via the USPTO patent electronic filing system, and “Sequence Listing” and CRF text files cannot be compressed when submitted via the USPTO patent electronic filing system. If a user wishes to submit an electronic copy of a “Sequence Listing” or CRF text file that exceeds 100 megabytes, the “Sequence Listing” or CRF must be filed on read-only optical disc(s).

I. ASCII PLAIN TEXT FILE SUBMITTED VIA USPTO PATENT ELECTRONIC FILING SYSTEM

The Office strongly suggests filing the “Sequence Listing” required by 37 CFR 1.821(c) as an ASCII plain text file via the USPTO patent electronic filing system. See 37 CFR 1.821(c)(1). If sequence information is submitted in an application filed under 35 U.S.C. 111(a) as an ASCII plain text file or as a national stage application submitted under 35 U.S.C. 371 as an ASCII plain text file in compliance with 37 CFR 1.824 via the USPTO patent electronic filing system 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” under 37 CFR 1.821(c) and the CRF of the “Sequence Listing” under 37 CFR 1.821(e). See 37 CFR 1.821(e)(1). See 37 CFR 1.821(e)(2). Note that for applications filed under 35 U.S.C. 111(a), the specification must contain a statement in a separate paragraph (see 37 CFR 1.77(b)(5)) that incorporates by reference the material in the “Sequence Listing” ASCII plain text file identifying the name of the ASCII plain text file, the date of creation, and the size of the ASCII plain text file in bytes (see 37 CFR 1.823(b)(1)). However, an incorporation by reference statement is not required in an international application and is not required in an application file under 35 U.S.C. 371 where the “Sequence Listing” has been previously communicated to the International Bureau or originally filed in the USPTO and complies with Patent Cooperation Treaty Rule 5.2. See 37 CFR 1.821(c), 1.823(b)(2), and 1.825(c). See also MPEP § 2422.03(a) for additional information pertaining to USPTO patent electronic filing system submissions of a “Sequence Listing”.

II. ASCII PLAIN TEXT FILE ON READ-ONLY OPTICAL DISC

If the “Sequence Listing” as required by 37 CFR 1.821(c) is submitted on read-only optical disc(s) in accordance with 37 CFR 1.52(e), the specification must contain an incorporation by reference of the material on the read-only optical disc in a separate paragraph (see 37 CFR 1.77(b)(5)) identifying the name of the file, the date of creation, and the size of the file in bytes (37 CFR 1.823(b)(1)). However, an incorporation by reference statement is not required in an international application and is not required in an application file under 35 U.S.C. 371 where the “Sequence Listing” has been previously communicated to the International Bureau or originally filed in the USPTO and complies with Patent Cooperation Treaty Rule 5.2. See 37 CFR 1.821(c), 1.823(b)(2), and 1.825(c). It is noted that a “Sequence Listing” may be compressed using WinZip®, 7-Zip, or Unix®/Linux® Zip (37 CFR 1.824(b)(2)(ii)). If a compressed ASCII plain text file does not fit on a single read-only optical disc due to storage limitations of the read-only optical disc, the compressed ASCII plain text file may be split into multiple file parts and placed on multiple read-only optical discs which are labeled in compliance with 37 CFR 1.52(e)(5)(vi) and (37 CFR 1.824(b)(2)(iv)).

The read-only optical disc used to submit the “Sequence Listing” may also contain “Large Tables” if the table has more than 50 pages of text. See 1.52(e)(1)(iii) and 37 CFR 1.58(c), (f) and (i). The read-only optical 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 read-only optical discs are not identical, the Office will use the disc labeled “Copy 1” for further processing (37 CFR 1.58(i) ). See also MPEP § 608.05.

If the “Sequence Listing” is submitted in an application filed under 35 U.S.C. 111(a) as an ASCII plain text file in compliance with 37 CFR 1.824 on read-only optical disc(s) in accordance with 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” under 37 CFR 1.821(c) and the CRF of the “Sequence Listing” under 37 CFR 1.821(e). See 37 CFR 1.821(e)(1). Similarly, if the “Sequence Listing” is filed in a national stage application submitted under 35 U.S.C. 371 as an ASCII plain text file in compliance with 37 CFR 1.824 on read-only optical disc(s) in accordance with 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” under 37 CFR 1.821(c) and the CRF of the “Sequence Listing” under 37 CFR 1.821(e).

A.ASCII Plain Text Files Up to 300 MB

When the “Sequence Listing” or CRF is submitted via read-only optical disc(s), the text file may either be compressed or not compressed. If the ASCII plain text file is not compressed, the ASCII plain text file must be contained on a single read-only optical disc. However, if the file does not fit on a single read-only optical disc even after compression, a compressed ASCII plain text file may be split into multiple file parts, in accordance with the target read-only optical disc size, and labeled in compliance with 37 CFR 1.52(e)(5)(vi). See 37 CFR 1.824(b).

B.ASCII Plain Text Files 300 MB or Over

Any “Sequence Listing” ASCII plain text file of 300 MB or more is subject to a fee under 37 CFR 1.21(o) to manage handling of the oversized submission (37 CFR 1.52(f)(3)). 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 Listing” 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, which is difference between the current fee and the prior paid 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 in the international stage, 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.