[Federal Register Volume 68, Number 172 (Friday, September 5, 2003)]
[Notices]
[Pages 52749-52751]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-22612]


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DEPARTMENT OF COMMERCE

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

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general public and other Federal agencies to take this opportunity to 
comment on the continuing and proposed 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 November 4, 
2003.

ADDRESSES: Direct all written comments to Susan K. Brown, Records 
Officer, Office of the Chief Information Officer, Office of Data 
Architecture and Services, Data Administration Division, 703-308-7400, 
U.S. Patent and Trademark Office, P.O. Box 1450, Alexandria, Virginia 
22313, Attn: CPK 3 Suite 310; by e-mail at [email protected]; or by 
facsimile at 703-308-7407.

FOR FURTHER INFORMATION CONTACT: Requests for additional information 
should be directed to the attention of Robert J. Spar, Director, Office 
of Patent Legal Administration, United States Patent and Trademark 
Office (USPTO), P.O. Box 1450, Alexandria, VA 22313-1450; by telephone 
at 703-308-5107; 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, 1.801-809. 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: Individuals or households; 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 0.25 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: 3,501 hours per 
year.
    Estimated Total Annual Respondent Cost Burden: $105,315 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 $252 for associate attorneys in private firms, the USPTO 
estimates $315 per year for salary costs associated with the average 
depository seeking approval to store biological material.

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                                                                                     Estimated       Estimated
                     Item                          Estimated time for response        annual       annual burden
                                                                                     responses         hours
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Deposited Materials...........................  1 hour..........................        3,500           3,500
Depository Approval...........................  5 hours.........................            0.25            1.25
===============================================
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    Estimated Total Annual Non-hour Respondent Cost Burden: $979,010. 
There are no maintenance costs or filing fees associated with this 
information collection. There are, however, capital start-up and 
postage 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, charges a one-time fee of 
$1,150 per deposit for basic storage and informing, and a minimum of 
$160 per deposit for viability testing, depending upon the type of 
deposit being tested. 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. This permit application 
processing fee is $150. The USPTO estimates that the total non-hour 
respondent cost burden in the form of capital start-up costs amounts to 
$1,460.
    In addition, this collection does have postage 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

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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 $141.80 per package for specimen shipments 
requiring refrigeration or dry ice. Therefore, postage costs average 
$279.30 per shipment, for a total cost to all the respondents of 
$977,550. The postage cost for a depository seeking recognition is 
estimated to be $3.85, 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 $977,551.

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                                                                                   Postage costs  Total non-hour
                              Item                                   Responses          ($)         cost burden
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                                                                          (a)                (b)       (a) x (b)
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Deposited Materials.............................................        3,500            $279.30     $977,550.00
Depository Approval.............................................            0.25            3.85            1.00
                                                                 =================

    The USPTO estimates that the total non-hour respondent cost burden 
for this collection in the form of capital start-up costs ($1,460) and 
postage costs ($977,551) amounts to $979,011.

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: August 29, 2003.
Susan K. Brown,
Records Officer, USPTO, Office of the Chief Information Officer, Office 
of Data Architecture and Services, Data Administration Division.
[FR Doc. 03-22612 Filed 9-4-03; 8:45 am]
BILLING CODE 3510-16-P