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 revision of a 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 October 13, 2009.

ADDRESSES:

You may submit comments by any of the following methods:

• E-mail: Susan.Fawcett@uspto.gov. Include A0651-0024 comment@ in the subject line of the message.
• Fax: 571-273-0112, marked to the attention of Susan K. Fawcett.
• Mail: Susan K. Fawcett, Records Officer, Office of the Chief Information Officer, Administrative Management Group, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
• Federal Rulemaking Portal: http://www.regulations.gov .

FOR FURTHER INFORMATION CONTACT:

Requests for additional information should be directed to Robert A. Clarke, Director, Office of Patent Legal Administration, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 571-272-7735; or by e-mail to Robert.Clarke@uspto.gov.

SUPPLEMENTARY INFORMATION:

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 sequence listing required by 37 CFR 1.821(c) for U.S. patent applications may be submitted on paper, compact disc (CD), or through EFS-Web, the USPTO's online filing system. 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 through EFS-Web may be submitted on a separate CD. Applicants may use EFS-Web to file a sequence listing online 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 a 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). 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 online through EFS-Web in the proper text format do not require a separate CRF copy or the associated statement.

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, 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.

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.

II. Method of Collection

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

III. Data

OMB Number: 0651-0024.

Form Number(s): PTO/SB/93.

Type of Review: Revision of a currently approved collection.

Affected Public: Individuals or households; businesses or other for-profits; and not-for-profit institutions.

Estimated Number of Respondents: 19,750 responses per year.

Estimated Time Per Response: The USPTO estimates that it will take the public approximately six minutes (0.10 hours) to one hour and 20 minutes (1.33 hours) to gather the necessary information, prepare the form or sequence listing, and submit it to the USPTO.

Estimated Total Annual Respondent Burden Hours: 7,254 hours per year.

Estimated Total Annual Respondent Cost Burden: $725,400 per year. The USPTO expects that the information in this collection will be prepared by paraprofessionals at an estimated rate of $100 per hour. Therefore, the USPTO estimates that the respondent cost burden for this collection will be approximately $725,400 per year.

Estimated Total Annual Non-hour Respondent Cost Burden: $920,959 per year. There are no maintenance costs associated with this collection. The USPTO provides free software for creating and validating the format of sequence listings prior to submission. However, this collection does have annual (non-hour) costs in the form of 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. While there is also no filing fee for a sequence listing filed in an international application, the basic international filing fee only covers the first 30 pages of the application. As a result, there is a $13 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 $1,950 if the international application were already at least 30 pages long without the listing. The USPTO estimates that approximately 380 of the 3,450 paper sequence listings submitted per year will be for international applications, for a total of $741,000 per year in page fees. There are no page fees for sequence listings that are submitted via EFS-Web in the proper text format.

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 $270 (or $135 for small entities) for each additional 50 pages or fraction thereof. The USPTO estimates that approximately 120 applications with long paper sequence listings from large entities will incur an average application size fee of $810, and approximately 95 applications with long paper sequence listings from small entities will incur an average application size fee of $405, for a total of $135,675 per year. Therefore, this collection has a total of $876,675 in 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 865 CD submissions per year, for a total of $2,595. 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 4,315 CRF copies for paper and CD sequence listings at an estimated cost of $2 per copy, for a total of $8,630. Therefore, this collection has total capital start-up costs of $11,225 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 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 865 CD submissions will be received per year, for a total of 104 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 $100 per hour, for a recordkeeping cost of $10,400 per year.

There are also recordkeeping costs associated with submitting sequence listings online using EFS-Web. The USPTO recommends that customers print and retain a copy of the acknowledgment receipt after a successful online submission. The USPTO estimates that it will take five seconds (0.001 hours) to print a copy of the acknowledgment receipt and that approximately 12,935 sequence listings per year will be submitted via EFS-Web, for a total of approximately 13 hours per year for printing this receipt. The USPTO expects that these receipts will be printed by paraprofessionals at an estimated rate of $100 per hour, for a recordkeeping cost of $1,300 per year. Therefore, this collection has total recordkeeping costs of $11,700 per year associated with retaining copies of CDs and acknowledgment receipts.

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 $4.95 and that 4,315 sequence listings will be mailed to the USPTO per year, for a total postage cost of $21,359 per year.

The total non-hour respondent cost burden for this collection in the form of fees, capital start-up costs, recordkeeping costs, and postage costs is estimated to be $920,959 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.