[Federal Register Volume 75, Number 26 (Tuesday, February 9, 2010)]
[Pages 6348-6349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2764]



Patent and Trademark Office

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: [email protected]. Include ``0651-0022 
Deposit of Biological Materials comment'' in the subject line of the 
     Fax: 571-273-0112, marked to the attention of Susan K. 
     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 [email protected].


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. Sec.  122

[[Page 6349]]

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 

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 
    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.

                                                                  Estimated time     Estimated       Estimated
                              Item                                 for response       annual       annual burden
                                                                      (hours)        responses         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 
x 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 
    (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.
[FR Doc. 2010-2764 Filed 2-8-10; 8:45 am]