E6-9343. 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 August 14, 2006.

ADDRESSES:

You may submit comments by any of the following methods:

E-mail: [e-mail]. Include “0651-0024 comment” in the subject line of the message.

Fax: [phone], marked to the attention of Susan Brown.

Mail: Susan K. Brown, Records Officer, Office of the Chief Information Officer, Architecture, Engineering and Technical Services, Data Architecture and Services Division, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.

Federal e-Rulemaking Portal: http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:

Requests for additional information should be directed to Robert J. Spar, Director, Office of Patent Legal Administration, U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 571-272-7700; or by e-mail at [e-mail].

I. 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. The rules of practice require applicants to submit these sequence listings in a standard international format that is consistent with World Intellectual Property Organization (WIPO) Standard ST.25 (1998). Applicants may submit sequence listings for both U.S. 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 (files larger than 600K or approximately 300 printed pages) are published only in electronic form and are available to the public on the USPTO sequence data Web page.

The USPTO recognizes that the submission of massive paper versions of extremely long sequence listings would place a significant burden on applicants and the USPTO, while also being of minimal utility for examination purposes. Consequently, applicants may submit the sequence listing required by 37 CFR 1.821(c) on paper or compact disc (CD). Applicants may also file sequence listings for U.S. applications 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.

Under 37 CFR 1.821(e)-(f), 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 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, the applicant must also submit a new CRF copy of the amended listing. Applicants may submit the CRF copy of the sequence listing to the USPTO on CD or other acceptable media as provided in 37 CFR 1.824. Sequence listings that are submitted electronically using EFS do not require a separate CRF copy.

This information collection contains the sequence listings that are submitted with biotechnology patent applications. Information pertaining to the filing of the initial patent application itself is collected under OMB Control Number 0651-0032, and international applications submitted under the Patent Cooperation Treaty (PCT) are covered under OMB Control Number 0651-0021. Customers may use a checkbox on Form PTO/SB/05 Utility Patent Application Transmittal, which is covered under OMB Control Number 0651-0032, to indicate the submission of a sequence listing for a U.S. patent application. The USPTO also provides a sample format for the transmittal documentation that must be submitted with a sequence listing on CD for an international patent application. Applicants who submit sequence listings using EFS must complete the electronic transmittal forms included within the submission software.

II. Method of Collection

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

III. Data

OMB Number: 0651-0024.

Form Number(s): None.

Type of Review: Revision 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: 15,382 responses per year.

Estimated Time per Response: The USPTO estimates that it will take the public approximately ten minutes (0.17 hours) to one hour and 20 minutes (1.33 hours) to gather the necessary information, prepare the sequence listing, and submit it to the USPTO, depending on whether the listing is submitted on paper, on CD, or electronically.

Estimated Total Annual Respondent Burden Hours: 17,297 hours per year.

Estimated Total Annual Respondent Cost Burden: $1,556,730 per year. The USPTO expects that the information in this collection will be prepared by paraprofessionals at an estimated rate of $90 per hour. Therefore, the USPTO estimates that the respondent cost burden for this collection will be approximately $1,556,730 per year.

Item	Estimated time for response	Estimated annual responses	Estimated annual burden hours
Sequence Listing in Application (paper)	1 hour and 20 minutes	11,512	15,311
Sequence Listing in Application (CD)	1 hour	1,600	1,600
Electronic Sequence Listing in Application (EFS)	10 minutes	2,270	386
Total		15,382	17,297

Estimated Total Annual Non-hour Respondent Cost Burden: $4,285,658 per year. There are no maintenance costs associated with this collection. The USPTO provides free software for creating and validating the format of the sequence listings prior to submission. However, this collection does have annual (non-hour) costs in the form of filing fees, capital start-up costs, recordkeeping costs, and postage costs.

There is no separate filing fee for submitting a sequence listing as part of a U.S. patent application, but there is a filing fee of $4,800 for submitting a sequence listing in electronic form (on CD) as part of an international PCT application. The USPTO estimates that approximately 200 of the 1,600 CD sequence listings submitted per year will be for international applications, for a total of $960,000 per year. While there is no additional fee for a sequence listing filed on paper in an international application, the basic international filing fee only covers the first 30 pages of the application. As a result, there is a $12 fee per page that is added to the international filing fee for each page over 30 pages. The average length of a paper sequence listing in an international application is 150 pages, which would carry an additional fee of $1,800 if the international application were already at least 30 pages long without the listing. The USPTO estimates that approximately 1,560 of the 11,512 paper sequence listings submitted per year will be for international applications, for a total of $2,808,000 per year. Therefore, this collection has $3,768,000 per year in filing fees that may be associated with paper and CD sequence listings for international applications.

Under 37 CFR 1.16(s) and 1.492(j), both U.S. and international patent applications that include lengthy paper sequence listings may be subject to an application size fee. For applications with paper sequences listings that exceed 100 pages, the application size fee is $250 (or $125 for small entities) for each additional 50 pages or fraction thereof. The USPTO estimates that approximately 400 applications with long paper sequence listings will incur an average application size fee of $750, and approximately 310 applications with long paper listings from small entities will incur an average application size fee of $375, for a total of $416,250 per year. Therefore, this collection has a total of $4,184,250 in filing fees per year.

There are capital start-up costs associated with submitting sequence listings and CRF copies to the USPTO on CD. Applicants who submit sequence listings on CD must submit two copies of the CD (or three copies for international applications) along with a transmittal letter stating that the copies are identical. This process requires additional supplies, including blank recordable CD media and padded envelopes for shipping. The USPTO estimates that the cost of these supplies will be approximately $3 per CD submission and that it will receive approximately 1,600 CD submissions per year, for a total of $4,800. In addition, customers who submit sequence listings on paper or CD must also submit a separate CRF copy of the listing, which may be submitted on CD. The USPTO estimates that it will receive approximately 13,112 CRF copies for paper and CD sequence listings at an estimated cost of $2 per copy, for a total of $26,224. Therefore, this collection has total capital start-up costs of $31,024 per year associated with submitting sequence listings and CRF copies on CD.

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 five minutes to produce a back-up CD copy and two minutes to print copies of documentation, for a total of seven minutes (0.12 hours) to make a back-up copy of the CD submission. The USPTO estimates that approximately 1,600 CD submissions will be received per year, for a total of 192 hours for making back-up CD copies. The USPTO expects that these back-up copies will be prepared by paraprofessionals at an estimated rate of $90 per hour, for a total recordkeeping cost of $17,280 per year.

Customers may incur postage costs when submitting a sequence listing to the USPTO by mail. Mailed submissions may include the sequence listing on either paper or CD, the CRF copy of the listing on CD, and a transmittal letter containing the required identifying information. The USPTO estimates that the average postage cost for a paper or CD sequence listing submission will be $4.05 and that 13,112 sequence listings will be mailed to the USPTO per year, for a total postage cost of $53,104 per year.

The total non-hour respondent cost burden for this collection in the form of filing fees, capital start-up costs, recordkeeping costs, and postage costs is estimated to be $4,285,658 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: June 9, 2006.

Susan K. Brown,

Records Officer, USPTO, Office of the Chief Information Officer, Architecture, Engineering and Technical Services, Data Architecture and Services Division.