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Federal Register / Vol. 86, No. 126 / Tuesday, July 6, 2021 / Proposed Rules
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.
Section 1.835b is proposed to be added to require that 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
containing the entire Sequence Listing XML, including any additions, deletions, or replacements of sequence information, and shall be submitted either i via the USPTO patent electronic filing system, or ii on a readonly optical disc, in compliance with 1.52e labeled as REPLACEMENT
MM/DD/YYYY with the month, day, and year of creation indicated; 2 an instruction 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 Authority for an international application; 3 a statement that identifies the location of all additions, deletions or replacements of sequence information relative to the 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.
Section 1.835c is proposed to be added to require that the specification of a complete application with a Sequence Listing XML as required under 1.831a present on the application filing date but 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.

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Section 1.835d1 is proposed to be added to provide that when any of the requirements of 1.831 through 1.834
is 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. The proposed rule indicates that subject to 1.835d2, any amendment to add or replace a Sequence Listing XML in reply to a requirement under this paragraph must be submitted in accordance with the requirements of 1.835a through c.
Section 1.835d2 is proposed to be added to explicitly provide that compliance with 1.835a through c 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 1.835a through c. Even though 1.52b1ii and 1.495c1i require a translation for applications filed under 111a and for those entering the national stage, respectively, this proposed rule makes explicit that when a translated Sequence Listing XML is provided as a reply to a notice that the Sequence Listing XML contains nonEnglish values for the invention title and/or any language-dependent free text elements, and the translation does not include deletions, additions or replacement of sequence information, the translated Sequence Listing XML
need not comply with the requirements for an amended Sequence Listing XML as set forth in 1.835a through c.
Section 1.835e is proposed to be added to provide that when 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 calling for compliance with the requirements within a prescribed time period. Under PCT Rule 13ter, applicant can provide, in reply to
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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.
Section 1.835f is proposed to be added to provide that 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.
Section 1.839: Section 1.839 is proposed to be added to provide the location of WIPO Standard ST.26 2020
that is being incorporated by reference.
III. Rulemaking Considerations A. Administrative Procedure Act: The changes proposed in this rulemaking involve rules of agency practice and procedure, and/or interpretive rules. See Bachow Commcns Inc. v. FCC, 237 F.3d 683, 690 D.C. Cir. 2001 rules governing an application process are procedural under the Administrative Procedure Act; Inova Alexandria Hosp.
v. Shalala, 244 F.3d 342, 350 4th Cir.
2001 rules for handling appeals are procedural where they do not change the substantive standard for reviewing claims; Natl Org. of Veterans Advocates v. Secy of Veterans Affairs, 260 F.3d 1365, 1375 Fed. Cir. 2001
rule that clarifies interpretation of a statute is interpretive.
Accordingly, prior notice and opportunity for public comment for the changes proposed in this rulemaking are not required pursuant to 5 U.S.C. 553b or c, or any other law. See Cooper Techs. Co. v. Dudas, 536 F.3d 1330, 133637 Fed. Cir. 2008 stating that 5
U.S.C. 553, and thus 35 U.S.C.
2b2B, do not require notice and comment rulemaking for interpretative rules, general statements of policy, or rules of agency organization, procedure, or practice quoting 5 U.S.C.
553bA. However, the USPTO has chosen to seek public comment before
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