2010-2764. Deposit of Biological Materials

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 this 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 April 12, 2010.

ADDRESSES:

You may submit comments by any of the following methods:

• E-mail: [e-mail]. Include “0651-0022 Deposit of Biological Materials comment” in the subject line of the message.
• Fax: [phone], marked to the attention of Susan K. Fawcett.
• Mail: Susan K. Fawcett, Records Officer, Office of the Chief Information Officer, United States 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 the attention of Brian Hanlon, Director, Office of Patent Legal Administration, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 571-272-5047; or by e-mail at [e-mail].

SUPPLEMENTARY INFORMATION:

I. Abstract

The deposit of biological materials as part of a patent application is required by 35 U.S.C. 2(b)(2) and outlined in 37 CFR Ch. 1, Subpart G, 1.801-1.809. Every patent must contain a description of the invention sufficient to enable a person (knowledgeable in the relevant science), to make and use the invention as specified by 35 U.S.C. 112. The term biological includes material that is capable of self-replication either directly or indirectly. When the invention involves a biological material, sometimes words alone cannot sufficiently describe how to make and use the invention in a reproducible or repeatable manner. In such cases, the required biological material must be both known and readily available (neither condition alone is sufficient) or be deposited in a suitable depository that has been recognized as an International Depository Authority (IDA) established under the Budapest Treaty, or a depository recognized by the USPTO to meet the requirements of 35 U.S.C. 112.

In cases where a deposit is necessary, it must be made under conditions that assure access to those entitled thereto under 37 CFR 1.14 and 35 U.S.C. § 122 and upon issuance as a patent that all restriction to public access permanently removed.

In order to meet and satisfy requirements for international patenting, all countries signing the Budapest Treaty must recognize the deposit of biological material with any International Depository Authority (IDA).

II. Method of Collection

By mail, facsimile, or hand delivery to the USPTO when the applicant or agent files a patent application with the USPTO or submits subsequent papers during the prosecution of the application to the USPTO.

III. Data

OMB Number: 0651-0022.

Form Number(s): None.

Type of Review: Extension of a currently approved collection.

Affected Public: Businesses or other for-profits.

Estimated Number of Respondents: 3,500 responses per year for deposited materials and 1 response per year for depository approval.

Estimated Time Per Response: The USPTO estimates that it will take the public approximately 1 to 5 hours, depending upon the complexity of the situation, to gather, prepare, and submit the various documents in this information collection.

Estimated Total Annual Respondent Burden Hours: 3,505 hours per year.

Estimated Total Annual Respondent Cost Burden: $106,625 per year to submit the information to the USPTO. Using the professional hourly rate of $30 for a senior administrative assistant, the USPTO estimates $105,000 per year for salary costs associated with collecting and submitting the necessary deposit information. Using the professional hourly rate of $325 for attorneys in private firms, the USPTO estimates $1,625 per year in respondent cost burden associated with the average depository seeking approval to store biological material.

Item	Estimated time for response (hours)	Estimated annual responses	Estimated annual burden hours
Deposited Materials	1	3,500	3,500
Depository Approval	5	1	5
Total		3,501	3,505

Estimated Total Annual (non-hour) Respondent Cost Burden: $9,831,120. There are no maintenance or record keeping costs or filing fees associated with this information collection. There are, however, capital start-up and mailing costs.

Depositories charge fees to depositors; all depositories charge about the same rates for their services. For example, the American Type Culture Collection (ATCC), one of the world's leading biological supply houses and recognized patent depositories, offers comprehensive patent services for $2,500 per deposit. Most deposits received from outside the United States require an import permit from the U.S. Department of Agriculture (USDA) as well as a Public Health Service (PHS) permit, available from the Centers for Disease Control and Prevention (CDC), for importation of agents infectious to humans. There is no extra charge for this permit application processing. The USPTO estimates that the total non-hour respondent cost burden in the form of capital start-up costs amounts to $8,750,000.

In addition, this collection does have mailing costs. Biological deposits are generally shipped to the depository “Domestic Overnight” by Federal Express (FedEx) and, since depositors are urged to supply frozen or freeze-dried material, it must be packed in dry ice according to a representative from the Patent Department at ATCC. Dry Ice itself is considered dangerous goods and requires special packaging. Additional FedEx special handling charges for inaccessible dangerous goods shipments of $32.50 per shipment apply for temperature-sensitive biological materials and also for the dry ice. An average cost for shipping by FedEx “Domestic Overnight” is estimated to be $75. If the shipment requires pick-up by FedEx, there is an additional charge of $2.20. Special packaging is also required for these shipments. According to DG Supplies Inc., a supplier of infectious and diagnostic goods packaging, the average cost of frozen infectious shippers is estimated to be $199.19 per package of four for specimen shipments requiring refrigeration or dry ice. Therefore, postage costs average $308.89 per shipment, for a cost to respondents of $1,081,115 ($308.89 × 3,500).

The postage cost for a depository seeking recognition is estimated to be $4.80, sent to the USPTO by priority mail through the United States Postal Service. Since the USPTO estimates that it receives one request for recognition from a depository every four years, the postage cost averages $4.80 per depository request, for a rounded cost to respondents of $5.00.

The USPTO estimates that the (non-hour) respondent cost burden in the form of mailing costs amounts to $1,081,120 ($1,081,115 + $5).

Therefore, the USPTO estimates that the total (non-hour) respondent cost burden for this collection in the form of capital start-up costs ($8,750,000) and mailing costs ($1,081,120) is $9,831,120.

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, including through 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 will also become a matter of public record.

Dated: February 2, 2010.

Susan K. Fawcett,

Records Officer, USPTO, Office of the Chief Information Officer.