MPEP § 2414.03 — Amendment Adding to, Deleting from, or Replacing Sequence Information in a “Sequence Listing XML” under 37 CFR 1.835(b) (Annotated Rules)
§2414.03 Amendment Adding to, Deleting from, or Replacing Sequence Information in a “Sequence Listing XML” under 37 CFR 1.835(b)
This page consolidates and annotates all enforceable requirements under MPEP § 2414.03, 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 Adding to, Deleting from, or Replacing Sequence Information in a “Sequence Listing XML” under 37 CFR 1.835(b)
This section addresses Amendment Adding to, Deleting from, or Replacing Sequence Information in a “Sequence Listing XML” under 37 CFR 1.835(b). Primary authority: 37 CFR 1.831(a), 37 CFR 1.835, and 37 CFR 1.831. Contains: 4 requirements, 2 permissions, and 3 other statements.
Key Rules
Sequence Listing Format
(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:
…
(5) A statement that the replacement “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 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.
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) 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) 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) 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) 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) A statement that no new matter is introduced by the content of the replacement “Sequence Listing XML” (37 CFR 1.835(b)(5)).
Applicant response to a notice or an Office action requiring a replacement “Sequence Listing XML” would involve submitting the following:
…
(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.
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 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.
Statement Under Article 19
(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) 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:
- (i) Via the USPTO patent electronic filing system; or
- (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) 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) 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.
PAIR/Patent Center Status
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.
Citations
| Primary topic | Citation |
|---|---|
| Statement Under Article 19 | 37 CFR § 1.52(e) |
| Statement Under Article 19 | 37 CFR § 1.77(b)(5)(ii) |
| PAIR/Patent Center Status 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(b)(1) |
| Sequence Listing Format | 37 CFR § 1.835(b)(3) |
| Sequence Listing Format | 37 CFR § 1.835(b)(4) |
| Sequence Listing Format | 37 CFR § 1.835(b)(5) |
| 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 § 2414.03 — Amendment Adding to, Deleting from, or Replacing Sequence Information in a “Sequence Listing XML” under 37 CFR 1.835(b)
Source: USPTO2414.03 Amendment Adding to, Deleting from, or Replacing Sequence Information in a “Sequence Listing XML” under 37 CFR 1.835(b) [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.
-
*****
- (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) 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:
- (i) Via the USPTO patent electronic filing system; or
- (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) 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) 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.
- (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:
-
*****
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) 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) 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) 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) 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) 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.