§ 1.821 - Nucleotide and/or amino acid sequence disclosures in patent applications.

§ 1.821 Nucleotide and/or amino acid sequence disclosures in patent applications.

Cross Reference

Link to an amendment published at 86 FR 57048, Oct. 14, 2021.

(a) Nucleotide and/or amino acid sequences, as used in §§ 1.821 through 1.825, are interpreted to mean an unbranched sequence of four 4 or more amino acids or an unbranched sequence of ten 10 or more nucleotides. Branched sequences are specifically excluded from this definition. Sequences with fewer than four specifically defined nucleotides or amino acids are specifically excluded from this section. “Specifically defined” means those amino acids other than “Xaa” and those nucleotide bases other than “n”defined in accordance with the World Intellectual Property Organization (WIPO) Handbook on Industrial Property Information and Documentation, Standard ST.25: Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings in Patent Applications (1998), including Tables 1 through 6 in Appendix 2, herein incorporated by reference. (Hereinafter “WIPO Standard ST.25 (1998)”). This incorporation by reference was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies of WIPO Standard ST.25 (1998) may be obtained from the World Intellectual Property Organization; 34 chemin des Colombettes; 1211 Geneva 20 Switzerland. Copies may also be inspected at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html. “n,” defined in accordance with Appendices A through F to this subpart. Nucleotides and amino acids are further defined as follows:

(1) Nucleotides:. Nucleotides are intended to embrace only those nucleotides that can be represented using the symbols set forth in WIPO Standard ST.25 (1998), Appendix 2, Table 1. Modifications, Appendix A to this subpart. Modifications (e.g., methylated bases, ) may be described as set forth in WIPO Standard ST.25 (1998), Appendix 2, Table 2, Appendix B to this subpart but shall not be shown explicitly in the nucleotide sequence.

(2) Amino acids:. Amino acids are those L-amino acids commonly found in naturally occurring proteins and are listed in WIPO Standard ST.25 (1998), Appendix 2, Table 3. appendix C to this subpart. Those amino acid sequences containing D-amino acids are not intended to be embraced by this definition. Any amino acid sequence that contains post-translationally modified amino acids may be described as the amino acid sequence that is initially translated using the symbols shown in WIPO Standard ST.25 (1998), Appendix 2, Table 3 appendix C to this subpart, with the modified positions ; (e.g., hydroxylations or glycosylations, ) being described as set forth in WIPO Standard ST.25 (1998), Appendix 2, Table 4, appendix D to this subpart, but these modifications shall not be shown explicitly in the amino acid sequence. Any peptide or protein that can be expressed as a sequence using the symbols in WIPO Standard ST.25 (1998), Appendix 2, Table 3 appendix C to this subpart, in conjunction with a description in the Feature section, to describe, for example, modified linkages, cross links and end caps, non-peptidyl bonds, etc., is embraced by this definition.

Note 1 to paragraph (a):

Appendices A through F to this subpart contain Tables 1-6 of the World Intellectual Property Organization (WIPO) Handbook on Industrial Property Information and Documentation, Standard ST.25: Standard for the Presentation of Nucleotide and Amino Acid Sequence Listings in Patent Applications (2009).

(b) Patent applications which contain disclosures of nucleotide and/or amino acid sequences, in accordance with the definition in paragraph (a) of this section, shall, with regard to the manner in which the nucleotide and/or amino acid sequences are presented and described, conform exclusively to the requirements of §§ 1.821 through 1.825.

(c) Patent applications which that contain disclosures of nucleotide and/or amino acid sequences, as defined in paragraph (a) of this section, must contain , as a “Sequence Listing,” which is a separate part of the disclosure, a paper or compact disc copy (see § 1.52(e)) disclosing the specification containing each of those nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of §§ 1.822 and 1.823. This paper or compact disc copy is referred to elsewhere in this subpart as the “Sequence Listing.” Each sequence disclosed must appear separately in the “Sequence Listing.” Each sequence set forth in the “Sequence Listing” must be assigned a separate sequence identifier. The sequence identifiers must begin with 1 and increase sequentially by integers. If no sequence is present for a sequence identifier, the code “000” must be used in place of the sequence. The response for the numeric identifier <160>must include the total number of SEQ ID NOs, whether followed by a sequence or by the code “000.” The “Sequence Listing” must be submitted as follows, except for a national stage entry under § 1.495(b)(1), where the “Sequence Listing” has been previously communicated by the International Bureau or originally filed in the United States Patent and Trademark Office and complies with Patent Cooperation Treaty (PCT) Rule 5.2:

(1) As an ASCII plain text file, in compliance with § 1.824, submitted via the USPTO patent electronic filing system or on a read-only optical disc under § 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 § 1.77(b)(5);

(2) As a PDF file via the USPTO patent electronic filing system; or

(3) On physical sheets of paper.

(d) Where the description or claims of a patent application discuss a sequence that is set forth in the “Sequence Listing” Listing,” in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the a sequence identifier (§ 1.823(a)(5)), preceded by “SEQ ID NO:” or the like, in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application.

(e) A copy of the “Sequence Listing” referred to in

Where a sequence is presented in a drawing, reference must be made to the sequence by use of the sequence identifier (§ 1.823(a)(5)), either in the drawing or in the Brief Description of the Drawings, where the correlation between multiple sequences in the drawing and their sequence identifiers (§ 1.823(a)(5)) in the Brief Description is clear.

(e)

(1) If the “Sequence Listing” under paragraph (c) of this section

must also be submitted in computer readable form (CRF)

is submitted in an application filed under 35 U.S.C. 111(a) as a PDF file (§ 1.821(c)(2)) via the USPTO patent electronic filing system or on physical sheets of paper (§ 1.821(c)(3)), then the following must be submitted:

(i) A CRF of the “Sequence Listing,” in accordance with the requirements of § 1.824

. The computer readable form must be a copy of the “Sequence Listing” and may not be retained as a part of the patent application file. If the computer readable form of a new application is to be identical with the computer readable form of another application of the applicant on file in the Office, reference may be made to the other application and computer readable form in lieu of filing a duplicate computer readable form in the new application if the computer readable form in the other application was compliant with all of the requirements of this subpart. The new application must be accompanied by a letter making such reference to the other application and computer readable form, both of which shall be completely identified. In the new application, applicant must also request the use of the compliant computer readable “Sequence Listing” that is already on file for the other application and must state that the paper or compact disc copy of the “Sequence Listing” in the new application is identical to the computer readable copy filed for the other application.

(f) In addition to the paper or compact disc copy required by paragraph (c) of this section and the computer readable form required by paragraph (e) of this section, a statement that the “Sequence Listing” content of the paper or compact disc copy and the computer readable copy are the same must be submitted with the computer readable form, e.g., a statement that “the sequence listing information recorded in computer readable form is identical to the written (on paper or compact disc) sequence listing.”

(

; and

(ii) A statement that the sequence information contained in the CRF submitted under paragraph (e)(1)(i) of this section is identical to the sequence information contained in the “Sequence Listing” under paragraph (c) of this section.

(2) If the “Sequence Listing” under paragraph (c) of this section in an application submitted under 35 U.S.C. 371 is a PDF file (paragraph (c)(2) of this section) or on physical sheets of paper (paragraph (c)(3) of this section), and not also as an ASCII plain text file, in compliance with § 1.824 (paragraph (c)(1) of this section), then the following must be submitted:

(i) A CRF of the “Sequence Listing,” in accordance with the requirements of § 1.824; and

(ii) A statement that the sequence information contained in the CRF submitted under paragraph (e)(2)(i) of this section is identical to the sequence information contained in the “Sequence Listing” under paragraph (c)(2) or (3) of this section.

(3) If a “Sequence Listing” in ASCII plain text format, in compliance with § 1.824, has not been submitted for an international application under the PCT, and that application contains disclosures of nucleotide and/or amino acid sequences, as defined in paragraph (a) of this section, and is to be searched by the United States International Searching Authority or examined by the United States International Preliminary Examining Authority, then the following must be submitted:

(i) A CRF of the “Sequence Listing,” in accordance with the requirements of § 1.824;

(ii) The late furnishing fee for providing a “Sequence Listing” in response to an invitation, as set forth in § 1.445(a)(5); and

(iii) A statement that the sequence information contained in the CRF, submitted under paragraph (e)(3)(i) of this section, 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, submitted under paragraph (e)(3)(i) of this section, is identical to the sequence listing contained in the international application as filed, as applicable.

(4) The CRF may not be retained as a part of the patent application file.

(f) [Reserved]

(g) If any of the requirements of paragraphs (b) through (fe) of this section are not satisfied at the time of filing under 35 U.S.C. 111(a) or at the time of entering the national stage under 35 U.S.C. 371, the applicant will be notified and given a period of time within which to comply with such requirements in order to prevent abandonment of the application. Any submission amendment to add or replace a “Sequence Listing” and CRF copy thereof in reply to a requirement under this paragraph must be accompanied by a statement that the submission includes no new matter. submitted in accordance with the requirements of § 1.825.

(h) If any of the requirements of paragraphs paragraph (be) through (f3) of this section are not satisfied at the time of filing an international application under the Patent Cooperation Treaty ( PCT), which and the application is to be searched by the United States International Searching Authority or examined by the United States International Preliminary Examining Authority, the applicant will may be sent a notice necessitating compliance with the requirements within a prescribed time period. Any submission Where a “Sequence Listing” under PCT Rule 13ter is provided in reply to a requirement under this paragraph, it must be accompanied by a statement that the submission does not include matter which goes information recorded in the ASCII plain text file under paragraph (e)(3)(i) of this section is identical to the sequence listing contained in the international application as filed, or does not go beyond the disclosure in the international application as filed, as applicable. It must also be accompanied by the late furnishing fee, as set forth in § 1.445(a)(5). If the applicant fails to timely provide the required computer readable formCRF, the United States International Searching Authority shall search only to the extent that a meaningful search can be performed without the computer readable form CRF, and the United States International Preliminary Examining Authority shall examine only to the extent that a meaningful examination can be performed without the computer readable formCRF.

[63 FR 29634, June 1, 1998, as amended at 65 FR 54680, Sept. 8, 2000; 69 FR 18803, Apr. 9, 2004; 70 FR 10489, Mar. 4, 2005; 86 FR 57048, Oct. 14, 2021]