[Editor Note: This section is applicable to all applications with a filing date, or, for national phase applications, an international filing date, on or after July 1, 2022, having disclosure of one or more nucleotide and/or amino acid sequences as defined in 37 CFR 1.831(b). Formatting representations of XML (eXtensible Markup Language) elements in this section appear different than shown in Standard ST.26, which may be accessed at: www.wipo.int /export/sites/www/standards/en/pdf/03-26-01.pdf.]

37 C.F.R. 1.835 Amendment to add or replace a "Sequence Listing XML" in patent applications filed on or after July 1, 2022.

1. *****

2. (d)(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 any language-dependent free text elements (as per § 1.833(b)(3) ). 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 (§ 1.833(b)(2)(iii) ) or elements of the general information part (§ 1.833(b)(2)(iv) ) are not considered amendments for purposes of complying with paragraphs (a) through (c) of this section.

3. *****

In accordance with 37 CFR 1.52(b)(1)(ii), any:

"application or proceeding and any amendments or corrections to the application (including any translation submitted pursuant to paragraph (d) of this section) or proceeding, except as provided for in § 1.69 and paragraph (d) of this section, must: *** (ii) Be in the English language or be accompanied by a translation of the application and a translation of any corrections or amendments into the English language together with a statement that the translation is accurate."

Thus, any "Sequence Listing XML" that contains one or more qualifiers having a free text value that is language-dependent must comprise an "INSDQualifier_value" element containing text in the English language, otherwise a translation of the "Sequence Listing XML" is required.

The provisions of 37 CFR 1.835(d)(2) indicate that providing a translation of such language-dependent free text values into English in a new "Sequence Listing XML" does not constitute an added or amended "Sequence Listing XML" under 37 CFR 1.835(a) or 1.835(b).