Deposit of Biological Materials, 64875-64877 [2016-22684]

Agencies

• DEPARTMENT OF COMMERCE
• United States Patent and Trademark Office

[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]


-----------------------------------------------------------------------

DEPARTMENT OF COMMERCE

United States Patent and Trademark Office


Deposit of Biological Materials

ACTION: Notice and request for comment.

-----------------------------------------------------------------------

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: InformationCollection@uspto.gov. Include ``0651-
0022 comment'' in the subject line of the message.
     Federal Rulemaking Portal: https://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 Raul.Tamayo@uspto.gov with ``0651-0022 comment'' in the 
subject line. Additional information about this collection is also 
available at https://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.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                       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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.................................  Deposited Materials..............          1 hour             900                900           30             27,000
2.................................  Depository Approval..............         5 hours               1                  5        65.51             327.55
                                   ---------------------------------------------------------------------------------------------------------------------
    Total............................................................................             901                905  ...........          27,327.55
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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.

----------------------------------------------------------------------------------------------------------------
                                                                     Estimated
             Item No.                     Item/type of cost           annual          Amount          Totals
                                                                     responses
----------------------------------------------------------------------------------------------------------------
                                                      FEES
----------------------------------------------------------------------------------------------------------------
1.................................  Deposited Materials.........             900       $2,500.00      $2,250,000

[[Page 64877]]

 
2.................................  Request for Depository                     1            0.00            0.00
                                     Approval.
                                   -----------------------------------------------------------------------------
    Total Fees..................................................................................       2,250,000
----------------------------------------------------------------------------------------------------------------
                                             PACKAGING/POSTAGE COSTS
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------
    Total Postage/Packaging.....................................................................      424,644.45
                                   -----------------------------------------------------------------------------
    Total Annual (Non-Hour) Cost Burden.........................................................    2,674,644.45
----------------------------------------------------------------------------------------------------------------

    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