[Federal Register Volume 71, Number 206 (Wednesday, October 25, 2006)]
[Notices]
[Pages 62423-62424]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-17855]


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PATENT AND TRADEMARK OFFICE


Deposit of Biological Materials

ACTION: Proposed collection; comment request.

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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 December 26, 
2006.

ADDRESSES: You may submit comments by any of the following methods:
     E-mail: [email protected]. Include ``0651-0022 
comment'' in the subject line of the message.
     Fax: 571-273-0112, 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 the attention of Robert J. Spar, Director, Office 
of Patent Legal Administration, U.S. Patent and Trademark Office 
(USPTO), P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 571-
272-7700; or by e-mail at [email protected].

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 Chapter 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 
either be known and readily (and continually) available, or be 
deposited in a suitable depository to meet the enablement and written 
description requirements of 35 U.S.C. 112.
    In cases where a novel microorganism is involved, the USPTO 
traditionally requires the deposit of a sample with a recognized patent 
depository in order to meet the above disclosure requirements. When a 
deposit is necessary, the USPTO collects information to determine 
whether the depositor is in compliance with the patent statute. This 
includes a statement proving notification to the interested public on 
where to obtain samples of the deposits. A viability statement showing 
that the biological material was tested by the depository, and is a 
viable or acceptable deposit, must also be submitted to the USPTO.
    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: Households and individuals; business or other for-
profit, not-for-profit institutions; and the Federal Government.
    Estimated Number of Respondents: 3,500 responses per year for 
deposited materials and 1 per year for depository approval.
    Estimated Time per Response: The USPTO estimates that it will take 
approximately 1 hour per application for deposited materials and 5 
hours per application for depository approval.
    Estimated Total Annual Respondent Burden Hours: 3,505 hours per 
year.
    Estimated Total Annual Respondent Cost Burden: $106,520 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 $304 for associate attorneys in private firms, the USPTO 
estimates $1,520 per year for salary costs associated with the average 
depository seeking approval to store biological material.

------------------------------------------------------------------------
                                                              Estimated
                                Estimated time   Estimated      annual
             Item                for response      annual       burden
                                                 responses      hours
------------------------------------------------------------------------
Deposited Materials..........  1 hour.........        3,500        3,500
Depository Approval..........  5 hours........            1            5
ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½ï¿½
    Total....................  ...............        3,501        3,505
------------------------------------------------------------------------

    Estimated Total Annual (Non-hour) Respondent Cost Burden: 
$9,850,929. There are no maintenance 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). Also required is 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

[[Page 62424]]

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 of $60 per 
shipment apply for temperature-sensitive biological material 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 $2.50. Special packaging is 
also required for these shipments. According to DG Supplies Inc., a 
supplier of infectious and diagnostic goods packaging, frozen 
infectious shippers are estimated to cost $177.05 per package for 
specimen shipments requiring refrigeration or dry ice. Therefore, 
mailing costs average $314.55 per shipment, for a total cost to all the 
respondents of $1,100,025. The postage cost for a depository seeking 
recognition is estimated to be $4.05, sent to the USPTO by priority 
mail through the United States Postal Service. Therefore, the USPTO 
estimates that the total non-hour respondent cost burden in the form of 
postage costs amounts to $1,100,929.

----------------------------------------------------------------------------------------------------------------
                                                                               Postage costs     Total non-hour
                             Item                                Responses          ($)           cost burden
                                                                        (a)               (b)          (a) x (b)
----------------------------------------------------------------------------------------------------------------
Deposited Materials...........................................        3,500           $314.55      $1,100,925.00
Depository Approval...........................................            1              4.05               4.00
                                                               -------------------------------------------------
    Total.....................................................        3,501  ................       1,100,929.00
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    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 ($1,100,929) amounts to $9,850,929.

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: October 19, 2006.
Susan K. Brown,
Records Officer, USPTO, Office of the Chief Information Officer, 
Architecture, Engineering and Technical Services, Data Architecture and 
Services Division.
[FR Doc. E6-17855 Filed 10-24-06; 8:45 am]
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