[Federal Register Volume 88, Number 38 (Monday, February 27, 2023)]
[Notices]
[Pages 12350-12351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03970]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
Agency Information Collection Activities; Submission to the
Office of Management and Budget (OMB) for Review and Approval; Comment
Request; Deposit of Biological Materials
The United States Patent and Trademark Office (USPTO) will submit
the following information collection request to the Office of
Management and Budget (OMB) for review and clearance in accordance with
the Paperwork Reduction Act of 1995, on or after the date of
publication of this notice. The USPTO invites comment on this
information collection renewal, which helps the USPTO assess the impact
of its information collection requirements and minimize the public's
reporting burden. Public comments were previously requested via the
Federal Register on November 22, 2022 during a 60-day comment period.
This notice allows for an additional 30 days for public comments.
Agency: United States Patent and Trademark Office, Department of
Commerce.
Title: Deposit of Biological Materials.
OMB Control Number: 0651-0022.
Needs and Uses: This collection covers information from patent
applicants who seek to deposit biological materials as part of a patent
application according to 37 CFR 1.801-1.809. 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 application 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, words and figures may not sufficiently describe
how to make and use the invention in a reproducible manner as required
by 35 U.S.C. 112. In such cases, the inventive biological material must
be known and readily available to the public or can be made or isolated
without undue experimentation (see 37 CFR 1.802). In order to satisfy
the ``known and readily available'' requirement, the biological
material may be deposited in a suitable depository that has been
recognized as an International Depositary Authority (IDA) established
under the Budapest Treaty per 37 CFR 1.803(a)(1), or any other
depository recognized to be suitable by the USPTO per 37 CFR
1.803(a)(2). 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.
In cases where a deposit of biological material that is capable of
self-replication either directly or indirectly is made, and the deposit
is not made under the Budapest Treaty, the USPTO collects information
to determine whether the deposit meets the viability requirements of 37
CFR 1.807. This information includes a viability statement under 37 CFR
1.807, such statement identifying:
(1) The name and address of the depository where the deposit was
made;
(2) The name and address of the depositor;
(3) The date of the deposit;
(4) The identity of the deposit and the accession number given by
the depository;
(5) The date of the viability test;
(6) The procedures used to obtain a sample if the test was not done
by the depository; and
(7) A statement that the deposit is capable of reproduction.
A viability statement is not required when a deposit is made and
accepted under the Budapest Treaty.
[[Page 12351]]
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 is not able to self-replicate,
and a replacement or supplemental deposit needs to be made. This
information collection includes a required written notification that
the depositor must submit to the USPTO disclosing the particulars of
such situation and request a certificate of correction by the USPTO
authorizing a replacement or supplemental deposit.
There are no forms associated with the information collected by the
USPTO in connection with the deposit of biological materials, however
there are forms available under the Budapest Treaty for use with
international depositories.
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(b) to make a request demonstrating that they are qualified to
store and test the biological materials submitted to them under patent
applications (see also MPEP 2405). This collection covers the
information that a depository must submit to the USPTO when seeking
recognition by the Office as a suitable depository under 37 CFR
1.803(a)(2). This information enables the USPTO to evaluate whether
such a depository has internal practices (both technical and
administrative) and the technical ability sufficient to protect the
integrity of the biological materials being stored by U.S. patent
applicants. This information includes:
(1) The name and address of the depository seeking recognition
under 37 CFR 1.803(a)(2),
(2) Detailed information as to the capacity of the depository to
comply with the requirements of 37 CFR 1.803(a)(2), including
information on its legal status, scientific standing, staff, and
facilities;
(3) An indication that the depository intends to be available, for
the purposes of deposit, to any depositor under these same conditions;
(4) Where the depository intends to accept for deposit only certain
kinds of biological material, specify such kinds; and
(5) An indication of the amount of any fees that the depository
will, upon acquiring the status of suitable depository under paragraph
(a) (2) of this section, charge for storage, viability statements and
furnishings of samples of the deposit.
This collection also includes additional information gathered by
the USPTO that may be needed after a depository has been recognized by
the USPTO under 37 CFR 1.803(a)(2), such as 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 under 37 CFR 1.803(b) to become a recognized depository.
Form Number(s): No form associated for domestic depositories; Forms
BP/1, BP/2, BP/3, BP/9 for use of international depositories under the
Budapest Treaty.
BP/1 (Statement in the Case of an Original Deposit (Rule
6.1)).
BP/2 (Statement in the Case of a New Deposit with the Same
International Depositary Authority (Rule 6.2)).
BP/3 (Statement in the Case of a New Deposit with Another
International Depositary Authority (Rule 6.2)).
BP/9 (Viability Statement (Rule 10.2) (International
Form)).
Type of Review: Extension and revision of a currently approved
information collection.
Affected Public: Private sector.
Respondent's Obligation: Required to obtain or retain benefits.
Frequency: On occasion.
Estimated Number of Annual Respondents: 3,301 respondents.
Estimated Number of Annual Responses: 3,301 responses.
Estimated Time per Response: The USPTO estimates that the responses
in this information collection will take the public approximately
between 1 hour and 5 hours to complete. This includes the time to
gather the necessary information, create the document, and submit the
completed request to the USPTO.
Estimated Total Annual Respondent Burden Hours: 3,305 hours.
Estimated Total Annual Respondent Non-Hourly Cost Burden:
$9,259,809.
This information collection request may be viewed at
www.reginfo.gov. Follow the instructions to view Department of
Commerce, USPTO information collections currently under review by OMB.
Written comments and recommendations for this information
collection should be submitted within 30 days of the publication of
this notice on the following website www.reginfo.gov/public/do/PRAMain.
Find this particular information collection by selecting ``Currently
under 30-day Review--Open for Public Comments'' or by using the search
function and entering either the title of the information collection or
the OMB Control Number 0651-0022.
Further information can be obtained by:
Email: [email protected]. Include ``0651-
0022 information request'' in the subject line of the message.
Mail: Justin Isaac, Office of the Chief Administrative
Officer, United States Patent and Trademark Office, P.O. Box 1450,
Alexandria, VA 22313-1450.
Justin Isaac,
Information Collections Officer, Office of the Chief Administrative
Officer, United States Patent and Trademark Office.
[FR Doc. 2023-03970 Filed 2-24-23; 8:45 am]
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