[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).]

When an application filed under 35 U.S.C. 111(a) having a filing date on or after July 1, 2022, or an application which entered the national stage, having an international filing date on or after July 1, 2022, contains disclosure of nucleotide and/or amino acid sequences, a "Sequence Listing XML" is required. When no "Sequence Listing XML" or a defective "Sequence Listing XML" is submitted in an application where a compliant "Sequence Listing XML" is required, the pre-examination staff will issue a notification that compliance with 37 CFR 1.831 - 1.835 is required and an added initial submission of a "Sequence Listing XML" (37 CFR 1.835(a) ) or replacement "Sequence Listing XML" (37 CFR 1.835(b) ) will be required. Additionally, the examiner can require the filing of a "Sequence Listing XML" if an application fails to comply with 37 CFR 1.831 - 1.834. For example, if there are sequences in the disclosure which are not part of the "Sequence Listing XML" of record, then the examiner can require a replacement "Sequence Listing XML" which includes the omitted sequences. See form paragraphs 24.18.26 - 24.20.26, 24.23.26, and 24.27.26-24.28.26.

[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).]

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. 1. (d)(1) If any of the requirements of §§ 1.831 through 1.834 are not satisfied in an application under 35 U.S.C. 111(a) 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 (d)(2) of this section, any amendment to add or replace a "Sequence Listing XML" or add an incorporation by reference of the material contained in the "Sequence Listing XML" in response to a requirement under this paragraph (d)(1) must be submitted in accordance with the requirements of paragraphs (a) through (c) of this section.

3. *****

Initial review by the pre-examination staff at the USPTO checks for compliance with formal matters. In order to ensure that an application is ready for examination, pre-examination staff check that applications containing disclosures of nucleotides and/or amino acid sequences have complied with the sequence listing rules. This means that for applications having a filing date on or after July 1, 2022, containing such sequence disclosures, a "Sequence Listing XML" must be of record and if not, applicant will be notified of such deficiency and provided instructions for responding. Adding a "Sequence Listing XML" where one was not previously filed must conform with the requirements of 37 CFR 1.835(a). See MPEP § 2414.02 for details. To amend a "Sequence Listing XML" due to errors or omissions, the procedure is outlined in 37 CFR 1.835(b). See MPEP § 2414.03 for details.

[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).]

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. (a) Any amendment to a patent application adding an initial submission of a "Sequence Listing XML" as required by § 1.831(a) after the application filing date must include:
   1. (1) A "Sequence Listing XML" in accordance with §§ 1.831 through 1.834, submitted as an XML file:
      1. (i) Via the USPTO patent electronic filing system; or
      2. (ii) On a read-only optical disc, in compliance with § 1.52(e);
   2. (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 § 1.77(b)(5)(ii) ), except when submitted to the United States International Preliminary Examining Authority for an international application;
   3. (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. (4) A statement that the "Sequence Listing XML" includes no new matter.

2. *****

Part of the pre-examination process as well as initial review by the examiner involves identifying whether an application that discloses nucleotide and/or amino acid sequences requires submission of a "Sequence Listing XML," and if so, if it contains a compliant "Sequence Listing XML." If pre-examination staff identifies that a "Sequence Listing XML" is required but missing or that compliance with 37 CFR 1.831 - 1.835 is lacking, a notice indicating the deficiencies will be issued to the applicant. Similarly, upon having a new application placed on the examiner’s docket, the examiner can assess whether a disclosure of nucleotide and/or amino acid sequences in the application requires a "Sequence Listing XML" to be submitted where one has not been submitted. The examiner can identify the requirement for a "Sequence Listing XML" on an "OPAP Routing Sheet" (Document Code "SEQREQ") and return the application to pre-examination for the mailing of a notice indicating the deficiencies.

Applicant's response to a notice or an Office Action requiring an initial "Sequence Listing XML" would involve providing the following:

1. (1) A compliant "Sequence Listing XML" submitted as an XML file using either the USPTO patent electronic filing system (currently, XML files can only be submitted via Patent Center) or a read-only optical disc that is mailed or hand-delivered into the Office. If the size of "Sequence Listing XML" file exceeds the upload limit of Patent Center, then it must be submitted on read-only optical disc. (37 CFR 1.835(a)(1) );
2. (2) An amendment to the specification to incorporate by reference the material in the "Sequence Listing XML" by reciting in a separate paragraph of the specification the name of the file, the date of creation, and the size of the file in bytes (37 CFR 1.835(a)(2) and 37 CFR 1.835(c) );
3. (3) A statement identifying the basis for the added "Sequence Listing XML," which would include, e.g., paragraphs of the originally filed specification or sheets of the drawings where a sequence is disclosed, identifying each sequence that is part of the "Sequence Listing XML" (37 CFR 1.835(a)(3) ); and
4. (4) A statement that no new matter is introduced by the content of the "Sequence Listing XML" (37 CFR 1.835(a)(4) ).

[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).]

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. (b) Any amendment adding to, deleting from, or replacing sequence information in a "Sequence Listing XML" submitted as required by § 1.831(a) must include:
   1. (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, which shall be submitted:
      1. (i) Via the USPTO patent electronic filing system; or
      2. (ii) On a read-only optical disc, in compliance with § 1.52(e), labeled as "REPLACEMENT MM/DD/YYYY" (with the month, day, and year of creation indicated);
   2. (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 § 1.77(b)(5)(ii) ), except when the replacement "Sequence Listing XML" is submitted to the United States International Preliminary Examining Authority for an international application;
   3. (3) A statement that identifies the location of all additions, deletions, or replacements of sequence information relative to the replaced "Sequence Listing XML";
   4. (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. (5) A statement that the replacement "Sequence Listing XML" includes no new matter.

3. *****

Part of the pre-examination process as well as initial review by the examiner involves identifying whether an application that discloses nucleotide and/or amino acid sequences contains a compliant "Sequence Listing XML." If pre-examination staff identifies that a previously submitted "Sequence Listing XML" contains errors and/or the application fails to comply with 37 CFR 1.831 - 1.834, a notice indicating the deficiencies will be issued to the applicant. Similarly, upon having a new application placed on the examiner’s docket, the examiner can identify errors in any "Sequence Listing XML" and/or instances of noncompliance with 37 CFR 1.831 - 1.834 that might not have been identified by pre-examination staff. The examiner can identify the outstanding requirements on a "OPAP Routing Sheet" (Document Code "SEQREQ") and return the application to pre-examination status for the mailing of a notice indicating the deficiencies.

Applicant response to a notice or an Office action requiring a replacement "Sequence Listing XML" would involve submitting the following:

1. (1) A compliant replacement "Sequence Listing XML" submitted as an XML file containing the entire "Sequence Listing XML," including any additions, deletions, or replacements of sequence information, using either the USPTO patent electronic filing system (currently, XML files can only be submitted via Patent Center) or a read-only optical disc that is mailed or hand-delivered into the Office. If the size of "Sequence Listing XML" file exceeds the upload limit of Patent Center, then it must be submitted on read-only optical disc (37 CFR 1.835(b)(1) );
2. (2) An amendment to the specification to incorporate by reference the material in the replacement "Sequence Listing XML" by reciting in a separate paragraph of the specification the name of the file, the date of creation, and the size of the file in bytes (37 CFR 1.835(b)(1) and 37 CFR 1.835(c) );
3. (3) A statement that identifies the location of all additions, deletions, or replacements of sequence information relative to the replaced "Sequence Listing XML" (37 CFR 1.835(b)(3) );
4. (4) A statement identifying the basis for the additions, deletions, or replacements of the sequence information in the application as originally filed for all amended sequence data in the replacement "Sequence Listing XML," which would include, e.g., paragraphs of specification or sheets of the drawings where a sequence is disclosed, identifying the sequence which is part of the replacement "Sequence Listing XML" (37 CFR 1.835(b)(4) ); and
5. (5) A statement that no new matter is introduced by the content of the replacement "Sequence Listing XML" (37 CFR 1.835(b)(5) ).

If applicant recognizes a deficiency in a previously submitted "Sequence Listing XML" or otherwise chooses to amend a previously submitted "Sequence Listing XML," a replacement "Sequence Listing XML" must be filed including all of the above-described items.

[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).

[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).]

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. (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, the applicant can provide, in response to such a requirement or otherwise, a sequence listing that is a "Sequence Listing XML" in accordance with § 1.831(a). 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. In response to such a requirement, the late furnishing fee set forth in § 1.445(a)(5) is also required. 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."

3. *****

Where an international application, filed under the PCT, contains a disclosure of nucleotide and/or amino acid sequences, PCT Rule 5.2 requires that the description shall include a sequence listing part of the description complying with the standard provided for in the Administrative Instructions (AI). In accordance with Section 208, any sequence listing, whether forming part of the international application or not forming part of the international application, shall comply with Annex C of the AI. Where applicant has not provided a sequence listing in accordance with Annex C of the AI and the USPTO acts as International Searching Authority (ISA) or International Preliminary Examining Authority (IPEA), the ISA/IPEA may invite applicant to furnish a sequence listing, with a late furnishing fee, under PCT Rule 13ter . This invitation will specify a time limit for a proper response. A proper response to such an invitation would include, the submission of a sequence listing accordance with Annex C of the AI, the late furnishing fee specified in 37 CFR 1.445(a)(5), and a statement to the effect that the sequence listing does not go beyond the disclosure of the international application as filed. If a sequence listing compliant with WIPO Standard ST.26 has not been furnished to the ISA/IPEA within the time limit set forth in the invitation, the ISA/IPEA will only search/examine the international application to the extent that a meaningful search or examination can be performed without the sequence listing.

See MPEP §§ 1823.02 and 1848.

[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).]

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. (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.

Where an amendment is made to a "Sequence Listing XML" contained in a patent, the correction must be made by way of an amendment to the "Sequence Listing XML" contained in a patent, pursuant to 1.835(b).