MPEP § 2414.02 — Amendment to Add an Initial “Sequence Listing XML” under 37 CFR 1.835(a) (Annotated Rules)
§2414.02 Amendment to Add an Initial “Sequence Listing XML” under 37 CFR 1.835(a)
This page consolidates and annotates all enforceable requirements under MPEP § 2414.02, including statutory authority, regulatory rules, examiner guidance, and practice notes. It is provided as guidance, with links to the ground truth sources. This is information only, it is not legal advice.
Amendment to Add an Initial “Sequence Listing XML” under 37 CFR 1.835(a)
This section addresses Amendment to Add an Initial “Sequence Listing XML” under 37 CFR 1.835(a). Primary authority: 37 CFR 1.831(a), 37 CFR 1.835, and 37 CFR 1.831. Contains: 4 requirements, 2 permissions, and 2 other statements.
Key Rules
Sequence Listing Format
(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:
…
(4) A statement that the “Sequence Listing XML” includes no new matter.
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.
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) 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) 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) 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) A statement that no new matter is introduced by the content of the “Sequence Listing XML” (37 CFR 1.835(a)(4)).
Applicant's response to a notice or an Office Action requiring an initial “Sequence Listing XML” would involve providing the following:
…
(4) A statement that no new matter is introduced by the content of the “Sequence Listing XML” (37 CFR 1.835(a)(4)).
Sequence Listing Content
[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).]
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.
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.
Statement Under Article 19
(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) 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 § 1.52(e);
- (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) 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.
Citations
| Primary topic | Citation |
|---|---|
| Statement Under Article 19 | 37 CFR § 1.52(e) |
| Statement Under Article 19 | 37 CFR § 1.77(b)(5)(ii) |
| Sequence Listing Content Sequence Listing Format Statement Under Article 19 | 37 CFR § 1.831 |
| Sequence Listing Format Statement Under Article 19 | 37 CFR § 1.831(a) |
| Sequence Listing Content | 37 CFR § 1.831(b) |
| Sequence Listing Format | 37 CFR § 1.835(a)(1) |
| Sequence Listing Format | 37 CFR § 1.835(a)(2) |
| Sequence Listing Format | 37 CFR § 1.835(a)(3) |
| Sequence Listing Format | 37 CFR § 1.835(a)(4) |
| Sequence Listing Format | 37 CFR § 1.835(c) |
Source Text from USPTO’s MPEP
This is an exact copy of the MPEP from the USPTO. It is here for your reference to see the section in context.
Official MPEP § 2414.02 — Amendment to Add an Initial “Sequence Listing XML” under 37 CFR 1.835(a)
Source: USPTO2414.02 Amendment to Add an Initial “Sequence Listing XML” under 37 CFR 1.835(a) [R-01.2024]
[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 CFR 1.835 Amendment to add or replace a “Sequence Listing XML” in patent applications filed on or after July 1, 2022.
- (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) 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 § 1.52(e);
- (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) 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.
- (1) A “Sequence Listing XML” in accordance with §§ 1.831 through 1.834, submitted as an XML file:
-
*****
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) 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) 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) 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) A statement that no new matter is introduced by the content of the “Sequence Listing XML” (37 CFR 1.835(a)(4)).