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Federal Register / Vol. 86, No. 126 / Tuesday, July 6, 2021 / Proposed Rules
optical disc size, and labeled in compliance with 1.52e5vi.

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1.835 Amendment to add or replace a Sequence Listing XML in patent applications filed on or after January 1, 2022.

a Any amendment to a patent application adding an initial submission of a Sequence Listing XML as required by 1.831a after the application filing date must include:
1 A Sequence Listing XML in accordance with 1.831 through 1.834, submitted as an XML file:
i Via the USPTO patent electronic filing system; or ii On a read-only optical disc, in compliance with 1.52e;
2 A request to amend the specification to include an incorporation by reference statement of the material in the Sequence Listing XML file, identifying the name of the file, the date of creation, and the size of the file in bytes see 1.77b5ii, except when submitted to the United States International Preliminary Examining Authority for an international application;
3 A statement that indicates the basis for the amendment, with specific references to particular parts of the application as originally filed specification, claims, drawings for all sequence data in the Sequence Listing XML; and 4 A statement that the Sequence Listing XML includes no new matter.
b Any amendment adding to, deleting from, or replacing sequence information in a Sequence Listing XML submitted as required by 1.831a must include:
1 A replacement Sequence Listing XML in accordance with the requirements of 1.831 through 1.834
containing the entire Sequence Listing XML including any additions, deletions, or replacements of sequence information, and shall be submitted:
i Via the USPTO patent electronic filing system; or ii On a read-only optical disc, in compliance with 1.52e labeled as REPLACEMENT MM/DD/YYYY with the month, day, and year of creation indicated;
2 A request to amend the specification to include an incorporation by reference statement of the material in the replacement Sequence Listing XML file that identifies the name of the file, the date of creation, and the size of the file in bytes see 1.77b5ii, except when the replacement Sequence Listing XML is submitted to the United States International Preliminary Examining
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Authority for an international application;
3 A statement that identifies the location of all additions, deletions, or replacements of sequence information relative to replaced Sequence Listing XML;
4 A statement that indicates the support for the additions, deletions, or replacements of the sequence information, with specific references to particular parts of the application as originally filed specification, claims, drawings for all amended sequence data in the replacement Sequence Listing XML; and 5 A statement that the replacement Sequence Listing XML includes no new matter.
c The specification of a complete application, filed on the application filing date, with a Sequence Listing XML as required under 1.831a, without an incorporation by reference of the material contained in the Sequence Listing XML file, must be amended to contain a separate paragraph incorporating by reference the material contained in the Sequence Listing XML file, in accordance with 1.77b5ii, except for international applications.
d1 If any of the requirements of 1.831 through 1.834 are not satisfied in an application under 35 U.S.C. 111a or in a national stage application 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. Subject to paragraph d2 of this section, any amendment to add or replace a Sequence Listing XML in reply to a requirement under this paragraph d1
must be submitted in accordance with the requirements of paragraphs a through c of this section.
2 Compliance with paragraphs a through c of this section is not required for submission of a Sequence Listing XML that is solely an English translation of a previously submitted Sequence Listing XML that contains non-English values for the invention title as per 1.833b3 and/or any language-dependent free text elements as per 1.833b4. The required submission will be a translated Sequence Listing XML in compliance with 1.831 through 1.834. Updated values for attributes in the root element 1.833b2iii or elements of the general information part 1.833b2iv are not considered amendments for purposes of complying with paragraphs a through c of this section.

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e If any of the requirements of 1.831 through 1.834 are not satisfied at the time of filing an international application under the PCT where 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 may be sent a notice necessitating compliance with the requirements within a prescribed time period. Under PCT Rule 13ter applicant can provide, in reply to such a requirement or otherwise, a sequence listing which is a Sequence Listing XML in accordance with 1.831a. The Sequence Listing XML must be accompanied by a statement that the information recorded does not go beyond the disclosure in the international application as filed. It must also be accompanied by the late furnishing fee set forth in 1.445a5.
If the applicant fails to timely provide the required Sequence Listing XML, the United States International Searching Authority shall search only to the extent that a meaningful search can be performed without the Sequence Listing XML, and the United States International Preliminary Examining Authority shall examine only to the extent that a meaningful examination can be performed without the Sequence Listing XML.
f Any appropriate amendments to the Sequence Listing XML in a patent e.g., by reason of reissue, reexamination, or certificate of correction must comply with the requirements of paragraph b of this section.
1.839

Incorporation by reference.

a Certain material is incorporated by reference into this subpart with the approval of the approval of the Director of the Federal Register under 5 U.S.C.
552a and 1 CFR part 51. All approved material is available for inspection at The United States Patent and Trademark Office, Office of Patent Legal Administration, 5712727701, and from the sources listed elsewhere in this section. It is also available for inspection at the National Archives and Records Administration NARA. For information on the availability of this material at NARA, email fedreg.legal@
nara.gov or go to www.archives.gov/
federal-register/cfr/ibr-locations.html.
b World Intellectual Property Organization WIPO; 34 chemin des Colombettes; 1211 Geneva 20
Switzerland, www.wipo.int.
1 WIPO Standard ST.26 2020.
WIPO Handbook on Industrial Property Information and Documentation, Standard ST.26: Recommended
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