03-10704. Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures

ACTION:

Proposed collection; comment request.

SUMMARY:

The United States Patent and Trademark Office (USPTO), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on the continuing information collection, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).

DATES:

Written comments must be submitted on or before June 30, 2003.

ADDRESSES:

Direct all written comments to Susan K. Brown, Records Officer, Office of Data Architecture and Services, Data Administration Division, U.S. Patent and Trademark Office, Suite 310, 2231 Crystal Drive, Arlington, VA 22202; by telephone at [phone]; or by electronic mail at [e-mail].

FOR FURTHER INFORMATION CONTACT:

Requests for additional information should be directed to Robert J. Spar, Director, Office of Patent Legal Administration, USPTO, P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at [phone]; or by electronic mail at [e-mail].

SUPPLEMENTARY INFORMATION:

I. Abstract

The requirements for submitting nucleotide and/or amino acid sequence disclosures as part of a patent application are outlined in 37 CFR 1.821-1.825. The rules of practice require patent applicants to submit these sequence listings in a standard international format that is consistent with World Intellectual Property Organization (WIPO) Standard ST.25 (1998). Sequence listings may be submitted for both national and international patent applications.

The USPTO uses the sequence listings during the examination process to determine the patentability of the associated patent application. Sequence listings are also disclosed as part of the published patent application or issued patent. Sequence listings that are extremely long (more than 600K or approximately 300 typed pages) are published only in electronic form and are available to the public on the USPTO sequence data web page.

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. Previously, the rules of practice required applicants to submit a paper copy of the sequence listing as the official archival copy. Due to the recognition that the submission of massive paper versions of extremely long sequence listings was a significant burden on applicants and the USPTO and of minimal utility for examination purposes, the USPTO amended the rules of practice in a Final Rule Notice published in the Federal Register on September 8, 2000, entitled “Changes to Implement the Patent Business Goals” (Vol. 65, No. 175), to allow the official copy of the sequence listing under 37 CFR 1.821(c) to be submitted either in paper or on compact disc (CD).

Under 37 CFR 1.821(e), applicants must also submit a copy of the sequence listing in “computer readable form” (CRF) with a statement indicating that the CRF copy of the sequence listing is identical to the official paper or CD copy required by 1.821(c). If an applicant later submits an amendment to the paper or CD copy of the sequence listing, a new CRF copy of the amended listing must also be submitted.

Applicants may submit the CRF copy of the sequence listing to the USPTO on CD, as provided in 37 CFR 1.824. Sequence listings may also be filed electronically using the Electronic Filing System (EFS) software developed by the USPTO for secure transmission of patent applications and related documents over the Internet. Applicants may use EFS to file a sequence listing electronically with a patent application or subsequent to a previously filed application.

There are no paper forms associated with the collection of sequence information filed with a patent application. Applicants who submit sequence listings electronically using EFS must complete the electronic transmittal forms provided within the electronic submission software provided by the USPTO. If a sequence listing is filed via EFS subsequent to a previously filed application, the CRF copy may be submitted electronically but the applicant must also mail a paper or CD copy of the sequence listing to the USPTO along with a statement indicating that the paper or CD copy and the CRF copy are identical.

In November 2001, OMB approved a change worksheet that increased the burden for this information collection due to increases in patent application filings involving nucleotide and amino acid sequence listings. However, although the total number of annual responses for this collection increased, the proportion of these responses that were submitted electronically was lower than originally estimated.

II. Method of Collection

By mail, hand delivery, or electronically over the Internet to the USPTO.

III. Data

OMB Number: 0651-0024.

Form Number(s): None.

Type of Review: Extension of a currently approved collection.

Affected Public: Individuals or households; businesses or other for-profits; not-for-profit institutions; farms; the Federal Government; and state, local or tribal governments.

Estimated Number of Respondents: 23,750 responses per year.

Estimated Time Per Response: The USPTO estimates that it will take the public approximately 1 hour and 20 minutes (1.33 hours) to gather the necessary information, prepare the paper sequence listing, and submit it to the USPTO. For sequence listings prepared on CD, the USPTO estimates that it will take the public approximately 1 hour to prepare and submit the sequence listing. For submissions filed electronically using EFS, the USPTO estimates that it will take the public approximately 10 minutes (0.17 hours) to prepare and submit the sequence listing.

Estimated Total Annual Respondent Burden Hours: 29,856 hours per year.

Estimated Total Annual Respondent Cost Burden: $895,680 per year. The USPTO expects that the information in this collection will be prepared by paraprofessionals at an estimated rate of $30 per hour. Therefore, the USPTO estimates that the respondent cost burden for this collection will be $895,680 per year.

Item	Estimated time for response	Estimated annual responses	Estimated annual burden hours
Sequence Listing in Application (paper)	1.33 hours	18,880	25,110
Sequence Listing in Application (CD)	1 hour	4,720	4,720
Electronic Sequence Listing in Application (EFS)	10 minutes	150	26
Total		23,750	29,856

Estimated Total Annual Non-hour Respondent Cost Burden: $50,598 per year. There are no maintenance costs or filing fees associated with this collection. There is no separate filing fee for submitting a sequence listing as part of a patent application. The USPTO also provides PatentIn authoring software for creating the sequence listing in the proper format, which may be downloaded at no cost from the USPTO Web site. However, this collection does have annualized costs in the form of capital start-up costs, recordkeeping costs, and postage costs.

There are capital start-up costs associated with submitting sequence listings to the USPTO on CD. Producing a CD requires additional hardware, software, and supplies, including a CD drive capable of recording onto CD media (a “CD burner”), CD recording software, blank recordable CD (CD-R) media, cases and labels for the CDs, and a padded mailing envelope for shipping. The cost of a CD burner is approximately $200, depending on the speed and type of PC connection. Commercial software for recording CDs retails for approximately $100, although basic CD recording software is typically included with the CD burner. The cost of blank CD-R media with plastic cases is approximately $10 for 10 blank CDs, and the cost of software and supplies for labeling CDs is approximately $20. Padded mailing envelopes for safely shipping the CDs cost approximately $12 for a package of 12. The total capital start-up cost for this collection is $342 per year.

Applicants who submit sequence listings on CD may also incur recordkeeping costs. The USPTO advises applicants to retain a back-up copy of CD submissions and associated documentation for their records. The USPTO estimates that it will take applicants 5 minutes to produce a back-up CD copy and 2 minutes to print copies of documentation, for a total of 7 minutes (0.12 hours) to make a back-up copy of the CD submission. The USPTO estimates that approximately 4,720 CD submissions will be received per year, for a total of 566 hours (4,720 responses multiplied by 0.12 hours). The USPTO expects that these back-up copies will be prepared by paraprofessionals at an estimated rate of $30 per hour, for a total recordkeeping cost of $16,980 per year.

Customers may incur postage costs when submitting a sequence listing to the USPTO by mail. The USPTO estimates that the average first-class postage cost for a mailed sequence listing submission on paper or CD will be $1.41 and that 23,600 sequence listings will be mailed to the USPTO per year. The total postage cost for this collection is $33,276 per year.

The total non-hour respondent cost burden for this collection in the form of capital start-up costs and postage costs is $50,598 per year.

IV. Request for Comments

Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden (including hours and cost) of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, e.g., the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized or included in the request for OMB approval of this information collection; they also will become a matter of public record.

Dated: April 23, 2003.

Susan K. Brown,

Records Officer, USPTO, Office of Data Architecture and Services, Data Administration Division.