37 C.F.R. 1.825 Amendments to or replacement of sequence listing and computer readable copy thereof.

1. (a) Any amendment to a paper copy of the "Sequence Listing" (§ 1.821(c) ) must be made by the submission of substitute sheets and include a statement that the substitute sheets include no new matter. Any amendment to a compact disc copy of the "Sequence Listing" (§ 1.821(c) ) must be made by the submission of a replacement compact disc (2 copies) in compliance with § 1.52(e). Amendments must also be accompanied by a statement that indicates support for the amendment in the application, as filed, and a statement that the replacement compact disc includes no new matter.
2. (b) Any amendment to the paper copy of the "Sequence Listing," in accordance with paragraph (a) of this section, must be accompanied by a substitute copy of the computer readable form (§ 1.821 (e)) including all previously submitted data with the amendment incorporated therein, accompanied by a statement that the copy in computer readable form is the same as the substitute copy of the "Sequence Listing."
3. (c) Any appropriate amendments to the "Sequence Listing" in a patent; e.g., by reason of reissue or certificate of correction, must comply with the requirements of paragraphs (a) and (b) of this section.
4. (d) If, upon receipt, the computer readable form is found to be damaged or unreadable, applicant must provide, within such time as set by the Commissioner, a substitute copy of the data in computer readable form accompanied by a statement that the substitute data is identical to that originally filed.

37 CFR 1.825 sets forth the procedures for amending the "Sequence Listing" and the computer readable copy thereof. The procedures that have been defined in 37 CFR 1.825 involve the submission of either substitute sheets or substitute compact discs of the "Sequence Listing" or substitute copies of the computer readable form, in conjunction with statements that indicate support for the amendment in the application, as filed, and that the substitute sheets or copies include no new matter. (See MPEP § 608.05 and § 2428 for further information.) An amendment to the material on a compact disc must be done by submitting a replacement compact disc with the amended file(s). The amendment should include a corresponding amendment to the description of the compact disc and the files contained thereon in the paper portion of the specification. A replacement compact disc containing the amended files also must contain all of the files of the original compact disc that were not amended. This will insure that the Office, printer, and public can quickly access all of the current files in an application or patent by referencing only the latest compact disc.The requirement for statements regarding the absence of new matter follows current practice relating to the submission of substitute specifications, as set forth in 37 CFR 1.125. 37 CFR 1.825(c) addresses the situation where amendments to the "Sequence Listing" are made after a patent has been granted, e.g., by a certificate of correction, reissue or reexamination. 37 CFR 1.825(d) addresses the possibility and presents a remedy for the situation where the computer readable form may be found by the Office to be damaged or unreadable.