Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures

Forms and Documents

Document Name	Status
Form PTO/SB/93 Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e) Form	Modified
0024 CWS 05 2022.docx Justification for No Material/Nonsubstantive Change	2022-05-20
Information Quality Guidelines _ USPTO.html Supplementary Document	2022-05-20
0651-0024 Supporting Statement July 2019 Final.docx Supporting Statement A	2019-07-26

IC Document Collections

IC ID	Document Title	Status
4695	Sequence Listing in Application (paper)	Removed
45201	Electronic Sequence Listing in Application	Modified
45200	Sequence Listing in Application (CD)	Modified
190812	Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e) Form	Modified

ICR Details

OMB Control No: 0651-0024	ICR Reference No: 202205-0651-001
Status: Received in OIRA	Previous ICR Reference No: 201906-0651-003
Agency/Subagency: DOC/PTO	Agency Tracking No:
Title: Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/20/2022

	Requested	Previously Approved
Expiration Date	09/30/2022	09/30/2022
Responses	23,850	28,850
Time Burden (Hours)	133,955	163,955
Cost Burden (Dollars)	1,263,473	1,573,140

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Abstract: Patent applications that contain nucleotide and/or amino acid sequence disclosures must include a copy of the sequence listing in accordance with the requirements in 37 CFR 1.821-1.825. Applicants submit copies of sequence listings for both U.S. and international biotechnology patent applications. The USPTO uses the sequence listings during the examination process to determine the patentability of the associated patent application. The USPTO also uses the sequence listings to support publication of patent applications and issued patents. Sequence listings are searchable after publication. This information collection covers the submission of the sequence listing information itself. Information pertaining to the filing of the initial U.S. patent application is collected under OMB Control Number 0651-0032, and information pertaining to the filing of the initial international application is collected under OMB Control Number 0651-0021. In particular, this information collection accounts for sequence listings submitted on paper, compact disc (CD), or through EFS-Web, the USPTO’s online filing system. Sequence listings may be submitted via EFS-Web as an ASCII text file or in Portable Document Format (PDF). For U.S. applications, § 1.821(c) permits all modes of submission: paper, CD, or EFS-Web. Sequence listings for international applications may be submitted on paper or through EFS-Web only, though sequence listings that are too large to be filed electronically though EFS-Web may be submitted on CD. This information collection also accounts for the requirement under § 1.821(e) that a copy of the sequence listing required by § 1.821(c) be submitted in computer readable form (CRF) in accordance with the requirements of § 1.824. Under §§ 1.821(e)–(f), applicants who submit their sequence listings on paper, CD, or as a PDF via EFS-Web must submit a copy of the sequence listing in CRF with a statement indicating that the CRF copy of the sequence listing is identical to the paper, CD, or PDF copy provided under § 1.821(c). Applicants may submit the CRF copy of the sequence listing to the USPTO on CD or other acceptable media as provided in § 1.824. If a new application is filed via EFS-Web with an ASCII text file sequence listing that complies with the requirements of §§ 1.824(a)(2)–(6) and (b), and applicant has not filed a sequence listing on paper, CD or as a PDF file, the text file will serve as both the copy required by § 1.821(c) and the CRF required by § 1.821(e). Moreover, the associated statement of identity would not be required. This information collection also covers the mechanism in § 1.821(e) where an applicant may request, in limited circumstances, a transfer of the CRF from the application already on file to the new application, if the CRF sequence listing in a new application is identical to the CRF sequence listing of another application that the applicant already has on file at the USPTO. In such a case, the applicant may submit a letter identifying the application and CRF sequence listing that is already on file and stating that the sequence listing submitted in the new application is identical to the CRF copy already filed with the previous application. The USPTO provides a form, Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e) (PTO/SB/93), in order to assist customers in submitting this statement.

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Authorizing Statute(s): US Code: 35 USC 22
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking	87 FR 30806	05/20/2022

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 16652	04/22/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 35376	07/23/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Electronic Sequence Listing in Application
Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e)	PTO/SB/93	Request for Transfer of a Computer Readable Form Under 37 CFR 1.821(e)
Sequence Listing in Application (CD)
Sequence Listing in Application (paper)

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ICR Summary of Burden

	Total Request	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	23,850	28,850	0	-5,000	0	0
Annual Time Burden (Hours)	133,955	163,955	0	-30,000	0	0
Annual Cost Burden (Dollars)	1,263,473	1,573,140	0	-309,667	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: This request is to remove the paper-based Sequence Listing in Application (IC No. 1) in response to rulemaking 0651-AD53 (Standard for Presentation of Nucleotide and Amino Acid Sequence Listings Using eXtensible Markup Language (XML) in Patent Applications to Implement WIPO Standard ST.26; Incorporation by Reference), because the Rule amends the rules of practice for these submissions by incorporating by reference certain provisions of World Intellectual Property Office Standard ST.26 (WIPO Standard ST.26) into the USPTO rules of practice. With this change in submissions the annual number of responses will decrease by 5,000 and the annual time burden will decrease by 30,000 in this request. The annual non-hour cost burden will decrease by $309,667 because of the removal of fees and postage associated with the removed item.

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Annual Cost to Federal Government: $514,435

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 05/20/2022

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