SUPPORTING STATEMENT
United States Patent and Trademark Office
Deposit of Biological Materials
OMB CONTROL NUMBER 0651-0022
(November 2016)
This supporting statement 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 United States Patent and Trademark Office (USPTO) to store biological materials. These different requirements are addressed in separate sections. Section 1.a. deals with the deposit of biological materials and section 1.b. deals with the depositories. There are no forms associated with this collection.
1. Necessity of Information 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) and required by 37 CFR 1.801-1.809. Every patent must contain a written description of the invention sufficient to enable a person (of ordinary skill in the relevant art) to make and use the invention as specified by 35 U.S.C. § 112. 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. 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, it must be made under conditions that assure that: (i) access to the deposit will be available to those entitled thereto under 35 U.S.C. § 122 and 37 CFR 1.14, and (ii) all restrictions to public access will be irrevocably removed upon the granting of the patent.
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 must also 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. In particular, a viability statement may be provided in one of two ways:
If a deposit that is acceptable under the Budapest Treat, then a mere
statement by an applicant, an authorized representative of applicant or the assignee that the deposit has been accepted under the Budapest Treaty would satisfy as a viability statement under 37 CFR 1.807; or
If a deposit is not made to a facility that is registered under the Budapest
Treaty, then a viability statement with the following information must be provided (see 37 CFR 1.807(b)):
The name and address of the depository;
The name and address of the depositor;
The date of deposit;
The identity of the deposit and the accession number given by the depository;
The date of the viability test;
The procedures used to obtain a sample if the test is not done by the depository; and
A statement that the deposit is capable of reproduction.
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 cannot function as described in the patent application, 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.
A deposit made before or during the pendency of an application will be kept for a term of at least 30 years, and for at least five years after the most recent request for the furnishing of a sample of the deposit was received by the depository. Samples must be stored under agreements that would make them available beyond the enforceable life of the patent for which the deposit was made.
In order to meet and satisfy requirements for international patenting, all countries signing the Budapest Treaty must recognize the deposit of biological material with any International Depositary Authority (IDA).
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. In particular, 37 CFR 1.803 requires the institution to direct a communication to the USPTO Director that shall:
indicate the name and address of the depository to which the communication relates;
contain detailed information as to the capacity of the depository to comply with the requirements of paragraph (a)(2) of 37 CFR 1.803, including information on its legal status, scientific standing staff, and facilities;
indicate that the depository intends to be available, for the purposes of deposit, to any depositor under these same conditions;
where the depository intends to accept for deposit only certain kinds of biological material, specify such kinds; and
indicate the amount of any fees that the depository will, upon acquiring the status of suitable depository under paragraph (a)(2) of 37 CFR 1.803, charge for storage, viability statements and furnishings of samples of the deposit.
USPTO rules are stringent to ensure the competence and quality of depositories. Depositories granted USPTO recognition must be established institutions with a long-standing reputation and recognized by their peers for the quality of their work. The depository must have a continuous existence, exist independent of the control of the depositor, and be impartial and objective. The USPTO determines the suitability of a depository based on its administrative and technical competence, and its agreement to comply with the requirements in this rule concerning the deposit of biological materials. 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.
Communication between the depository and the public occurs when the public requests a sample of a biological material deposited in the depository. Depositories also notify the depositors in writing whenever a sample is furnished.
Once a depository is recognized to be suitable by the USPTO, or has defaulted or discontinued its performance, notice thereof is required to be published in the Official Gazette of the United States Patent and Trademark Office.
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.
2. Needs and Uses
This information is used by the USPTO to determine whether the applicant has met the requirements of the patent regulations regarding deposits of biological materials. The USPTO also uses the information to determine the suitability of a respondent depository based upon administrative and technical competence and the depository’s agreement to comply with the requirements set forth by the USPTO.
The Information Quality Guidelines from Section 515 of Public Law 106-554, Treasury and General Government Appropriations Act for fiscal year 2001, apply to this information collection, and this information collection and its supporting statement comply with all applicable information quality guidelines, i.e. OMB and specific operating unit guidelines.
Table 1 provides the specific statutes and rules requiring the USPTO to collect the information discussed above and how this information is used by the public and the USPTO.
Item # |
Requirement |
Statute |
Rule |
Form # |
Needs and Uses |
1 |
Deposit of Biological Materials |
35 U.S.C. § 2(b)(2), 35 U.S.C. § 112 |
37 CFR 1.801-1.809, 37 CFR 1.14 |
No Form |
|
2 |
Depositories |
35 U.S.C. § 2(b)(2) |
37 CFR 1.803 |
No Form |
|
3. Use of Information Technology
Currently, the USPTO does not use automated, electronic, mechanical, or other technological collection techniques for this collection. As the USPTO expands electronic filing under the Electronic Filing System (EFS-Web), the Deposit of Biological Materials Program will be evaluated to determine whether electronic filing is feasible. The deposit of the physical specimen itself cannot be done electronically. If the USPTO determines that electronic filing of the documentation from depositories seeking consideration as an acceptable depository is both feasible and practicable, it will submit the electronic form or template to OMB for review.
4. Efforts to Identify Duplication
This information is collected during the prosecution of a patent application containing biological materials. It is not collected elsewhere. Therefore, this collection does not create a duplication of effort.
5. Minimizing the Burden to Small Entities
This collection of information does not impose a significant economic impact on small entities or small businesses. The same information is required of every applicant and is not available from any other source.
6. Consequences of Less Frequent Collection
This information is collected only when the respondent submits a patent application containing biological materials that cannot be adequately described in words only or when a depository seeks consideration as an acceptable depository. It could not be conducted less frequently. If the collection of information were not collected, the USPTO could not comply with the requirements of 35 U.S.C. § 2(b)(2) and 37 CFR 1.801-1.809.
7. Special Circumstances in the Conduct of Information Collection
There are no special circumstances associated with this collection of information.
8. Consultations Outside the Agency
The 60-Day Notice was published in the Federal Register on September 21, 2016 (81 Fed. Reg. 64875). The comment period ended on November 21, 2016. No public comments were received.
The USPTO has long-standing relationships with groups from whom patent application data is collected, such as the American Intellectual Property Law Association (AIPLA), as well as patent bar associations, independent inventor groups, and users of our public facilities. Views expressed by these groups are considered in developing proposals for information collection requirements.
9. Payment or Gifts to Respondents
This information collection does not involve a payment or gift to any respondent.
10. Assurance of Confidentiality
Confidentiality of patent applications is governed by statute (35 U.S.C. § 122) and regulation (37 CFR 1.11 and 1.14). The USPTO has a legal obligation to maintain the confidentiality of the contents of unpublished patent applications and related documents. Upon publication of an application or issuance of a patent, the patent application file is made available to the public, subject to the provisions for providing only a redacted copy of the file contents.
11. Justification for Sensitive Questions
None of the required information in this collection is considered to be sensitive.
12. Estimate of Hour and Cost Burden to Respondents
For clarity, the burden explanations have been separated into sections a. and b. Table 2 combines both the deposits of biological materials and the depositories’ information and calculates the burden hours and costs of this information collection to the public, based on the following factors:
a. Deposits of Biological Materials
Respondent Calculation Factors
The USPTO estimates that approximately 900 deposits of biological materials are made per year in order to meet the requirements of 35 U.S.C. § 112 for inventions pertaining to biological materials, with 3% of these from small entities.
These estimates are based on the Agency’s long-standing institutional knowledge of and experience with the type of information collected by these items.
Burden Hour Calculation Factors
The USPTO estimates that the burden hours required by the average patent applicant respondent to collect and submit the necessary deposit information would be 1 hour annually.
These estimates are based on the Agency’s long-standing institutional knowledge of and experience with the type of information collected and the length of time necessary to complete responses containing similar information.
Cost Burden Calculation Factors
The USPTO expects that a senior administrative assistant, at a rate of $30 per hour, would prepare this information.
b. Depositories
Respondent Calculation Factors
No depository has requested recognition by the USPTO to serve as a depository of biological materials since September 1994. Five existing depositories were grandfathered under current law in 1994. For the purpose of this submission, the USPTO estimates that one depository might seek recognition every four years, rounded up to 1 response annually.
These estimates are based on the Agency’s long-standing institutional knowledge of and experience with the type of information collected by these items.
Burden Hour Calculation Factors
The USPTO estimates that the burden hours required by the average depository seeking approval to store biological materials would be approximately 5 hours spent in collecting and submitting the necessary approval information.
These estimates are based on the Agency’s long-standing institutional knowledge of and experience with the type of information collected and the length of time necessary to complete responses containing similar information.
Cost Burden Calculation Factors
The USPTO uses a professional rate of $30.00 for those filing deposited materials, which is the standard estimate for the USTPO administrative rate. The USPTO uses a professional rate of $65.51 per hour for those completing a Request for Depository Approval, which is the mean rate for attorneys in private firms as shown in the Bureau of Labor Statistics (23-1011 Lawyers).
Item # |
Item |
Hours (a) |
Responses (yr) (b) |
Burden (hrs/yr) (c) (a) x (b) |
Rate ($/hr) (d) |
Total Cost ($/hr) (e) (c) x (d) |
1 |
Deposited Materials |
1.0 |
900 |
900 |
$30.00 |
$27,000.00 |
2 |
Request for Depository Approval |
5.0 |
1 |
5 |
$65.51 |
$327.55 |
|
Total |
- - - |
901 |
905 |
- - - |
$27,327.55 |
13. Total Annualized (Non-hour) Cost Burden
There are no maintenance costs, record keeping costs, or filing fees associated with this information collection. There are, however, 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). Also required is a Public Health Services (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 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 $75. If the shipment requires a 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, for a cost to respondents of $424,638.00.
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 postage cost averages $6.45 per depository request.
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.
14. Annual Cost to the Federal Government
For clarity, the burden explanations for the annual cost to the Federal Government have been separated into sections a. and b. Table 4 combines both the deposits of biological material and depositories’ information and calculates the burden hours and costs of this information collection to the Federal Government, based on the following factors:
a. Deposits of Biological Material
The USPTO estimates that it takes a GS-11, step 1 examiner, approximately 15 minutes (0.25 hours) to verify that biological materials have been deposited in compliance with the patent statute and regulations. The hourly rate for a GS-11, step 1 is currently $30.98. When 30% is added to account for a fully-loaded hourly rate (benefits plus overhead), the rate per hour for a GS-11, step 1, is $40.27 ($30.98 + $9.29).
b. Depositories
The USPTO estimates that it would take a GS-15, step 5, approximately 10 hours to recognize an applicant as a suitable depository. The hourly rate for a GS-15, step 5, is currently $69.56. When 30% is added to account for a fully-loaded hourly rate (benefits plus overhead), the rate per hour for a GS-15, step 5, is $90.43 ($69.56 + $20.87).
Table 3 calculates the processing hours and costs associated with this information collection to the Federal Government:
Item # |
Item |
Hours (a) |
Responses (yr) (b) |
Burden (hrs/yr) (c) (a) x (b) |
Rate ($/hr) (d) |
Total Cost ($/hr) (e) (c) x (d) |
1 |
Deposited Materials |
0.25 |
900 |
225 |
$40.27 |
$9,060.75 |
2 |
Request for Depository Approval |
10.0 |
1 |
10 |
$90.43 |
$904.30 |
|
Total |
- - - |
901 |
235 |
- - - |
$9,965.05 |
15. Reason for Change in Burden from the Current Inventory
Changes in collection since previous OMB approval in 2013
OMB previously approved this information collection in November 2013.
The current collection contains:
2,001 responses
2,005 burden hours
$61,855.00 in respondent hourly cost burden
$5,938,646.00 in annual (non-hour) costs
Changes proposed in this request to OMB
The proposed collection, as outlined in the tables above, seeks to modify the existing collection. The new proposed collection contains an estimated:
901 responses
905 burden hours
$27,327.55 in respondent hourly burden cost
$2,674,644.45 in annual (non-hourly) costs
Change in respondent cost burden
The total respondent cost burden for this collection has decreased by $34,527.45 (from $61,855.00 to $27,327.55) from the previous renewal of this collection in 2013 due to:
Decrease in estimated hourly rates. The 2013 renewal used estimated rates of $371 per hour, for attorney wages in this collection. For the current renewal, the USPTO is using updated an updated hourly rate of $65.51 for attorneys.
Decrease in estimated burden hours. The total estimated burden hours have decreased from 2,005 in the 2013 renewal to 905 for the current renewal due to overall decreases in the estimated annual responses for this collection.
For this renewal, the USPTO estimates that the annual responses will decrease by 1,100 (from 2,001 to 901) and the total burden hours will decrease by 1,100 (from 2,005 to 905) from the currently approved burden for this collection. These changes are due to the following administrative adjustments:
Decrease of 1,100 estimated annual responses for Deposited Materials, from 2,000 to 900; a burden decrease of 1,100 hours.
Changes in non-hourly cost burden
The total non-hourly cost burden for this collection has decreased by $3,264,001.55 (from $5,938,646.00 to $2,674,644.45) from the previous renewal due to:
Decrease in estimated responses. The total estimated responses have decreased by 1,100 due to overall decreases in the estimated annual responses for this collection.
16. Project Schedule
The USPTO does not plan to publish this information for statistical use. However, notice of recognized, defaulted or discontinued depositories is required to be published in the Official Gazette of the United States Patent and Trademark Office.
17. Display of Expiration Date of OMB Approval
There are no forms associated with this collection. Therefore, the display of the expiration date is not applicable.
18. Exception to the Certificate Statement
This collection of information does not include any exceptions to the certificate statement.
This collection of information does not employ statistical methods.
| File Type | application/msword |
| File Title | SF-12 SUPPORTING STATEMENT |
| Author | Galaxy Scientific Corporation |
| Last Modified By | Hall, Drew (AMBIT) |
| File Modified | 2016-11-25 |
| File Created | 2016-11-16 |