[Federal Register Volume 81, Number 183 (Wednesday, September 21, 2016)]
[Notices]
[Pages 64875-64877]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-22684]
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DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Deposit of Biological Materials
ACTION: Notice and request for comment.
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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 comment on the
renewal of a 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 November 21,
2016.
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 Management Division Director,
Office of the Chief Information 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 information collection covers both deposits of biological
materials and the depositories in which they are stored. While these
two topics are related, the information collection requirements for a
respondent depositing biological material are not the same as those
that must be followed by a respondent seeking approval from the USPTO
to store biological materials. These different requirements are
addressed in separate sections. Section I.A. deals with the deposit of
biological materials and section I.B. deals with the depositories.
There are no forms associated with this collection.
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.
Once a depositor has deposited biological materials into a
recognized depository, occasions may arise necessitating additional
communication between the depositor and the USPTO. 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, the depositor must 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.
To summarize, the nature of the information collected by the USPTO
in association with the deposit of biological materials is that of
certifications/statements, as described above, regarding a biological
sample deposited at a depository. There is no form 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. A depository seeking recognition from the USPTO to store
biological materials must show that 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.
USPTO rules are stringent to ensure the competence and quality of
depositories. Depositories must submit documentation to the USPTO 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.
Once a depository has been recognized by the USPTO, occasions may
arise where additional communication between the depository
[[Page 64876]]
and the USPTO is necessary. For example, a depository must request and
obtain written approval from the USPTO to handle additional types of
biological materials other than the material originally recognized.
Depositories may (on behalf of depositors) submit viability statements
for deposits tested at the depository and/or documentation proving the
public has been notified about where to obtain samples.
To summarize, the nature of the information collected by the USPTO
in connection with a respondent seeking approval from the USPTO to
store biological materials is that of a written request to the Director
of the USPTO containing the information outlined above. There is no
form for the request.
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: Revision of a currently approved collection.
Affected Public: Businesses or other for-profits; and not-for-
profit institutions.
Estimated Number of Respondents: 901 responses per year. The USPTO
estimates that approximately 3% 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: 905 hours.
Estimated Total Annual Respondent Cost Burden: $27,0327.55. The
USPTO estimates a professional hourly rate of $30 for a senior
administrative assistant 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 $65.51 (BLS rate; 23-1011 Lawyers) per hour. Therefore, the USPTO
estimates that the respondent cost burden for this collection will be
approximately $27,327.55 per year.
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Estimated time Estimated
No. Item for response annual Estimated annual Rate ($/hr) Total costs
(minutes) responses burden hours
(a) (b) (a) x (b)/60 = e (c) x (d) =
(c) (hourly cost
burden)
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1................................. Deposited Materials.............. 1 hour 900 900 30 27,000
2................................. Depository Approval.............. 5 hours 1 5 65.51 327.55
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Total............................................................................ 901 905 ........... 27,327.55
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Estimated Total Annual Non-hour Respondent Cost Burden:
$2,674,644.45. 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 $2,250,000.
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 of four 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 $6.45, 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 average postage cost to respondents is $6.45 per year.
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Estimated
Item No. Item/type of cost annual Amount Totals
responses
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FEES
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1................................. Deposited Materials......... 900 $2,500.00 $2,250,000
[[Page 64877]]
2................................. Request for Depository 1 0.00 0.00
Approval.
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Total Fees.................................................................................. 2,250,000
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PACKAGING/POSTAGE COSTS
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1................................. Deposited Materials--Federal 900 $119.00 $107,100.00
Express.
1................................. Deposited Materials-- 900 352.82 317,538.00
Packaging Supplies.
2................................. Request for Depository 1 6.45 6.45
Approval.
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Total Postage/Packaging..................................................................... 424,644.45
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Total Annual (Non-Hour) Cost Burden......................................................... 2,674,644.45
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The USPTO estimates that the (non-hour) respondent cost burden in
the form of mailing costs amounts to $424,644.45.
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 $2,674,644.45.
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.
The USPTO is soliciting public comments to:
(a) Evaluate whether the proposed 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
proposed 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.
Dated: September 15, 2016.
Marcie Lovett,
Records Management Division Director, OCIO United States Patent and
Trademark Office.
[FR Doc. 2016-22684 Filed 9-20-16; 8:45 am]
BILLING CODE 3510-16-P