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	New
USPTO-infoqualityguide-092008.pdf Supplementary Document	2009-12-02
0651-0024-JustStmt-2009-final.pdf Supporting Statement A	2009-12-10
r13ter.pdf Supplementary Document	2009-12-02
03-25-01.pdf Supplementary Document	2006-09-13

IC Document Collections

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

ICR Details

OMB Control No: 0651-0024	ICR Reference No: 200909-0651-002
Status: Historical Active	Previous ICR Reference No: 200609-0651-001
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: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/24/2010
	Date Received in OIRA: 12/11/2009
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2013	36 Months From Approved	02/28/2010
Responses	19,750	0	15,382
Time Burden (Hours)	103,750	0	17,297
Cost Burden (Dollars)	920,959	0	4,285,838

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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 and World Intellectual Property Organization (WIPO) Standard ST.25 (1998). Applicants may submit sequence listings for both U.S. and international patent applications. The sequence listings may be submitted on paper, compact disc, or electronically over the Internet. The USPTO uses the sequence listings to determine the patentability of the associated patent application and to support the publication of applications and issued patents. Applicants use sequence data when preparing biotechnology patent applications and may also search sequence listings after publication.

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Authorizing Statute(s): US Code: 35 USC 22 Name of Law: null
  

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

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 40163	08/11/2009
30-day Notice:	Federal Register Citation:	Citation Date:
	74 FR 63118	12/02/2009
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Electronic Sequence Listing in Application (EFS-Web)
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 (paper)
Sequence Listing in Application (CD)

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ICR Summary of Burden

	Total Approved	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	19,750	15,382	0	2,500	1,868	0
Annual Time Burden (Hours)	103,750	17,297	0	50	86,403	0
Annual Cost Burden (Dollars)	920,959	4,285,838	0	-896,920	-2,467,959	0

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

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to: Miscellaneous Actions

Short Statement: If the computer readable form (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, 37 CFR 1.821(e) permits the applicant to refer to the CRF listing in the other application rather than having to submit a duplicate copy of the CRF listing for the new application. 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 is proposing to add a new form to this collection, 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. The addition of this form results in an increase of 250 burden hours but is offset by a decrease in 200 burden hours from the elimination of CD sequence listing submissions for international applications, for a net increase of 50 burden hours as a program change. The increase of 86,403 burden hours from administrative adjustments is due to revised estimates for annual responses and time per response for sequence listing submissions. For annual cost burden, decreases of $896,920 from program changes are due to changes in fees and the elimination of CD sequence listing submissions for international applications, while decreases of $2,467,959 from administrative adjustments are based on revised estimates for annual responses that in turn result in a decrease in related annual costs.

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Annual Cost to Federal Government: $289,856

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

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

Is this ICR related to the Pandemic Response? Uncollected

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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: 12/11/2009

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