Agency Information Collection Activities; Submission to the Office of Management and Budget (OMB) for Review and Approval; Comment Request; Deposit of Biological Materials, 12350-12351 [2023-03970]

Agencies

• DEPARTMENT OF COMMERCE
• Patent and Trademark Office

[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]
BILLING CODE 3510-16-P