37 CFR § 1.825 - Amendments to or replacement of sequence listing and computer readable copy thereof.
(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.
(b) Any amendment to the paper or compact disc 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.”
(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.
(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 Director, a substitute copy of the data in computer readable form accompanied by a statement that the substitute data is identical to that originally filed.