2016-22684. 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: [e-mail]. 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 [e-mail] 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 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.

No.	Item	Estimated time for response (minutes)	Estimated annual responses	Estimated annual burden hours	Rate ($/hr)	Total costs
		(a)	(b)	(a) × (b)/60 = (c)	e	(c) × (d) = (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.

Item No.	Item/type of cost	Estimated annual responses	Amount	Totals
FEES
1	Deposited Materials	900	$2,500.00	$2,250,000
2	Request for Depository Approval	1	0.00	0.00
Total Fees				2,250,000
PACKAGING/POSTAGE COSTS
1	Deposited Materials—Federal Express	900	$119.00	$107,100.00
1	Deposited Materials—Packaging Supplies	900	352.82	317,538.00
2	Request for Depository Approval	1	6.45	6.45
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.