[Federal Register Volume 75, Number 26 (Tuesday, February 9, 2010)]
[Notices]
[Pages 6348-6349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-2764]
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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 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
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, 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].
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. 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
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.
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Estimated time Estimated Estimated
Item for response annual annual burden
(hours) responses hours
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Deposited Materials............................................. 1 3,500 3,500
Depository Approval............................................. 5 1 5
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Total....................................................... .............. 3,501 3,505
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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
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.
[FR Doc. 2010-2764 Filed 2-8-10; 8:45 am]
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