[Federal Register Volume 87, Number 224 (Tuesday, November 22, 2022)]
[Notices]
[Pages 71304-71306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25364]
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DEPARTMENT OF COMMERCE
United States 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
AGENCY: United States Patent and Trademark Office, Department of
Commerce.
ACTION: Notice 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 and revision of an existing information collection: 0651-
0022 Deposit of Biological Materials. The purpose of this notice is to
allow 60 days for public comment preceding submission of the
information collection to OMB.
DATES: To ensure consideration, comments regarding this information
collection must be received on or January 23, 2023.
ADDRESSES: Interested persons are invited to submit written comments by
any of the following methods. Do not submit Confidential Business
Information or otherwise sensitive or protected information.
Email: [email protected]. Include ``0651-
0022 comment'' in the subject line of the message.
Federal Rulemaking Portal: http://www.regulations.gov.
Mail: Justin Isaac, 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 Parikha Mehta, Senior Legal Advisor, United
States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA
22313-1450; by telephone at 571-272-3248; or by email at
[email protected] with ``0651-0022 comment'' in the subject line.
Additional information about this information 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
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
[[Page 71305]]
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.
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.
II. Method of Collection
Electronically via the USPTO's patent electronic filing system, by
mail or hand delivery to the USPTO.
III. Data
OMB Control Number: 0651-0022.
Forms: 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.
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, depending on the complexity of
the situation and item, to gather the necessary information, prepare
the appropriate document(s), and submit the information to the USPTO.
Estimated Total Annual Respondent Burden Hours: 3,305 hours.
Estimated Total Annual Respondent Hourly Cost Burden: $475,788.
[[Page 71306]]
Table 1--Total Burden Hours and Hourly Costs to Private Sector Respondents
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Estimated
Estimated Responses per Estimated annual Estimated time Estimated Rate \1\ ($/ annual
Item No. Item annual respondent responses per response burden (hour/ hour) respondent
respondents (hours) year) cost burden
(a) (b) (a) x (b) = (c) (d).............. (c) x (d) = (f) (e) x (f) =
(e) (g)
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1.......... Deposited Materials. 3,300 1 3,300 1................ 3,300 $143.96 $475,068
2.......... Request for 1 1 1 5................ 5 143.96 720
Depository Approval.
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Totals........... 3,301 ............... 3,301 ................. 3,305 .............. 475,788
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\1\ Bureau of Labor Statistic rate for attorneys in scientific research and development services (23-1011--Lawyers), plus 30% added for benefits and
overhead (https://www.bls.gov/oes/current/oes231011.htm).
Estimated Total Annual Respondent Non-hourly Cost Burden:
$9,259,809. There are no maintenance costs, record keeping costs, or
filing fees associated with this information collection. However, the
USPTO estimates that the total annual (non-hour) cost burden for this
information collection, in the form of capital start-up costs
($8,250,000) and postage ($1,009,809) is $9,259,809.
Captial Start-Up 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. Any deposits from outside the US may
have additional requirements, from other Federal Agencies, as a part of
their importation process. The USPTO estimates that the total non-hour
respondent cost burden in the form of capital start-up costs amounts to
$8,250,000 (3,300 respondents x $2,500).
Postage
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. Dry ice itself is considered dangerous goods 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 $90. If the shipment requires a pick-up by FedEx, there is an
additional charge of $6. Special packaging is also required for these
shipments. The average cost of frozen infectious shippers is estimated
to be $170 per package of four for specimen shipments requiring
refrigeration or dry ice. Therefore, the USPTO estimates the total
postage costs average $306 per shipment, for a cost to respondents of
$1,009,800 (3,300 respondents x $306).
The USPTO estimates that it will receive from depositorites 1
request for recognition. The USPTO estimates that the postage cost for
a mailed submission of a request for recognition from a depository
using a Priority Mail 2-day flat rate legal envelope is $9.25.
Therefore, the USPTO estimates that the total mailing costs for this
information collection is $9.00 per year.
IV. Request for Comments
The USPTO is soliciting public comments to:
(a) Evaluate 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) Evaluate the accuracy of the Agency's estimate of the burden of
the collection of information, including the validity of the
methodology and assumptions used;
(c) Enhance the quality, utility, and clarity of the information to
be collected; and
(d) Minimize the burden of the collection of information on those
who are to respond, 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.
All comments submitted in response to this notice are a matter of
public record. USPTO will include or summarize each comment in the
request to OMB to approve this information collection. Before including
an address, phone number, email address, or other personally
identifiable information (PII) in a comment, be aware that the entire
comment--including PII--may be made publicly available at any time.
While you may ask in your comment to withhold PII from public view,
USPTO cannot guarantee that it will be able to do so.
Justin Isaac,
Information Collections Officer, Office of the Chief Administrative
Officer, United States Patent and Trademark Office.
[FR Doc. 2022-25364 Filed 11-21-22; 8:45 am]
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