[Federal Register Volume 84, Number 223 (Tuesday, November 19, 2019)]
[Notices]
[Pages 63855-63857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24951]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
Deposit of Biological Materials
ACTION: Notice of renewal of information collection; request for
comment.
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SUMMARY: The United States Patent and Trademark Office (USPTO), as
required by the Paperwork Reduction Act of 1995, invites comments on
the extension of an existing information collection: 0651-0022 (Deposit
of Biological Materials).
DATES: Written comments must be submitted on or before January 21,
2020.
ADDRESSES: You may submit comments by any of the following methods:
Email: [email protected]. Include ``0651-
0022 comment'' in the subject line of the message.
Federal Rulemaking Portal: http://www.regulations.gov.
Mail: Marcie Lovett, Records and Information Governance
Branch, Office of the Chief Administrative Officer, United States
Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.
FOR FURTHER INFORMATION CONTACT: Requests for additional information
should be directed to Raul Tamayo, Senior Legal Advisor, Office of
Patent Legal Administration, United States Patent and Trademark Office,
P.O. Box 1450, Alexandria, VA 22313-1450; by telephone at 571-272-7728;
or by email to [email protected] with ``0651-0022 comment'' in the
subject line. Additional information about this collection is also
available at http://www.reginfo.gov under ``Information Collection
Review.''
SUPPLEMENTARY INFORMATION:
I. Abstract
This collection covers information from patent applicants who seek
to deposit biological materials as part of a patent application. The
information collected from such patent applicants consists of
information and documentation demonstrating the applicant's compliance
with regulatory requirements, as well as information regarding the
biological sample after it is deposited. This collection also covers
applications from institutions that wish to be recognized by the USPTO
as a suitable depository to receive deposits for patent purposes. The
information collection requirements for these actions are separate, as
further discussed below.
A. Deposits of Biological Materials
The deposit of biological materials as part of a patent application
is authorized by 35 U.S.C. 2(b)(2). The term ``biological material'' is
defined in 37 CFR 1.801 as including material that is capable of self-
replication, either directly or indirectly. When an invention involves
a biological material, sometimes words and figures are not sufficient
to satisfy the statutory requirement for patentability under 35 U.S.C.
112 (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). In such
cases, the required biological material must either be: (1) Known and
readily available (neither condition alone is sufficient) or (2)
deposited in a suitable depository that has been recognized as an
International Depositary Authority (IDA) established under the Budapest
Treaty, or a depository recognized by the USPTO to meet the
requirements of 35 U.S.C. 112. Under the authority of 35 U.S.C.
2(b)(2), the deposit rules (37 CFR 1.801-1.809) set forth examining
procedures and conditions of deposit which must be satisfied in the
event a deposit is required. The rules do not address the substantive
issue of whether a deposit is required under any particular set of
facts.
In cases where a deposit is necessary, the USPTO collects
information to determine whether the depositor is in compliance with
the deposit rules. This includes statements proving notification to the
interested public on where to obtain samples of the deposits and
confirming that all restriction on access to the deposit will be
irrevocably removed upon issuance of the patent. A viability statement
also must be submitted to the USPTO showing that the biological
material was tested by the depository or another, the conditions of the
test, and that it is a viable or acceptable deposit. A viability
statement is not required when a deposit is made and accepted under the
Budapest Treaty.
This collection also covers additional information that may be
gathered by the USPTO after a biological material is deposited into the
recognized depository. For example, depositors may be required to
submit verification statements for biological materials deposited after
the effective filing date of a patent application or written
notification that an acceptable deposit will be made. Occasionally a
deposit may be lost, contaminated, or otherwise is not able to self-
replicate, and a replacement or supplemental deposit needs to be made.
In that event, this collection covers the requirement that the
depositor submit a written notification to the USPTO concerning the
particulars of the situation and request a certificate of correction by
the USPTO authorizing the replacement or supplemental deposit.
There are no forms associated with the information collected by the
USPTO in connection with the deposit of biological materials.
B. Depositories
Institutions that wish to be recognized by the USPTO as a suitable
depository to receive deposits for patent purposes, are required by 37
CFR 1.803 to make a request demonstrating that they are qualified to
store and test the biological materials submitted to them under patent
applications. This collection covers the information gathered in the
request to allow the USPTO to evaluate whether such an institution has
demonstrated that its internal practices (both technical and
administrative) and the technical ability of the staff and the facility
are sufficient to protect the integrity of the biological materials
being stored. For example, this collection covers documentation from
depositories that verifies that their practices and procedures, the
technical competence of their staff, and their facilities fulfill the
stringent requirements spelled out under the rules.
This collection also covers additional information gathered by the
USPTO that may be needed after a depository has
[[Page 63856]]
been recognized by the USPTO. For example, this collection covers
requests to handle additional types of biological materials other than
the material originally recognized, and viability statements that
depositories may submit (on behalf of depositors) for deposits tested
at the depository and/or documentation proving the public has been
notified about where to obtain samples.
There is no application form associated with requests to become a
recognized depository.
II. Method of Collection
By mail, hand delivery, or electronically 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; and not-for-
profit institutions.
Estimated Number of Respondents: 951 responses per year. The USPTO
estimates that approximately 3% (28) of these responses will be from
small entities.
Estimated Time per Response: The USPTO estimates that it will take
the public 1 hour to gather the necessary information, prepare the
appropriate form or documents, and submit the information to the USPTO
for a deposit of biological materials. The USPTO estimates that it will
take the average depository seeking approval to store biological
materials approximately 5 hours to collect and submit the necessary
approval information.
Estimated Total Annual Respondent Burden Hours: 955 hours.
Estimated Total Annual Respondent Cost Burden: $33,021. The USPTO
estimates a professional hourly rate of $34.40 for a senior
administrative assistant (BLS rate; 43-1011 First Line Supervisors of
Office and Administrative Support Workers) to collect and submit the
deposit information. The USPTO expects that the average depository
seeking approval to store biological material will be prepared by
attorneys at an estimated rate of $68.22 (BLS rate; 23-1011 Lawyers)
per hour. Therefore, the USPTO estimates that the respondent cost
burden for this collection will be approximately $33,021 per year.
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Estimated time
IC No. Item for response Estimated annual Estimated annual Rate ($/hr) Total costs
(hours) responses burden hours
.......................... (a) (b) (a) x (b)/60 = (c) (d) (c) x (d) =
(hourly cost burden)
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1........................... Deposited Materials....... 1 950 950 $34.40 $32,680
2........................... Depository Approval....... 5 1 5 68.22 341
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Total................... .......................... ................ 951 955 ................ 33,021
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Estimated Total Annual Non-hour Respondent Cost Burden: $2,823,236.
There are no maintenance costs, recordkeeping costs, or filing fees
associated with this information collection. However, this collection
has annual (non-hour) costs in the form of 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, 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 $2,375,000.
In addition, this collection has 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 a dangerous good and requires special packaging.
Additional FedEx special handling charges for inaccessible dangerous
goods shipments of $40 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
$4. 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 $352.82 per package for specimen shipments requiring
refrigeration or dry ice. Therefore, postage costs average $471.82 per
shipment. The postage cost for a depository seeking recognition is
estimated to be $7.65, sent to the USPTO by USPS Priority Mail legal
flat rate envelope.
The USPTO estimates that the (non-hour) respondent cost burden in
the form of mailing costs amounts to $448,236.
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Estimated
Item No. Item/type of cost annual Amount Totals
responses
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Deposit Costs
1............................... Deposited Materials........... 950 $2,500.00 $2,375,000.00
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Total Fees................. .............. .............. 2,375,000.00
Packaging/Postage Costs
1............................... Deposited Materials--Mailing 950 $119.00 $113,050.00
Costs.
1............................... Deposited Materials--Packaging 950 352.82 335,179.00
Supplies.
2............................... Request for Depository 1 7.65 7.65
Approval.
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[[Page 63857]]
Total Postage/Packaging.... .............. .............. 448,236.65
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Total Annual (Non-Hour) .............. .............. 2,823,236.65
Cost Burden.
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Therefore, the USPTO estimates that the total (non-hour) respondent
cost burden for this collection in the form of capital start-up costs
and postage costs is $2,823,236.
IV. Request for Comments
Comments submitted in response to this notice will be summarized
and/or included in the request for OMB approval. All comments will
become a matter of public record.
USPTO invites public comments on:
(a) Whether the collection of information is necessary for the
proper performance of the functions of the agency, including whether
the information will have practical utility;
(b) Accuracy of the agency's estimate of the burden (including
hours and cost) of the proposed collection of information, including
the validity of the methodology and assumptions used;
(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, e.g., including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g., permitting electronic
submission of responses.
Marcie Lovett,
Records and Information Governance Branch, Office of the Chief
Administrative Officer, USPTO.
[FR Doc. 2019-24951 Filed 11-18-19; 8:45 am]
BILLING CODE 3510-16-P