0651-0022 SupStmt Nov2013 (final)

SUPPORTING STATEMENT
United States Patent and Trademark Office
Deposit of Biological Materials
OMB CONTROL NUMBER 0651-0022
(November 2013)
A.

JUSTIFICATION

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.

Deposited 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:
(1)
If a deposit is made 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
(2)
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.

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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.

Request for Depository Approval

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 longstanding 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

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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.
Table 1: Information Requirements and Needs and Uses of Information Collected
Item
#
1

Requirement

Statute

Rule

Form
#

Deposited Materials
-Samples
-Certification/Viability
Statements

35 U.S.C. § 2(b)(2),
35 U.S.C. § 112

37 CFR
1.801-1.809,
37 CFR 1.14

4

No Form

Needs and Uses
 Used by an applicant to determine
whether to file a new patent application.
 Used by an applicant to establish
enablement of claimed biological
material.
 Used by an applicant to establish
possession of the invention for priority
purposes.
 Used by an applicant to maintain

Item
#

Requirement

Statute

Rule

Form
#

Needs and Uses
enforceability of a patent.
 Used by the USPTO to determine
whether the requirement of 35 U.S.C. §
112, 1st paragraph, have been met.
 Used by the USPTO to determine
whether the depositor is in compliance
with deposit rules.

2

3.

Request for
Depository Approval

35 U.S.C. § 2(b)(2)

37 CFR
1.803

No Form

 Used by the respondent depositories to
determine the requirements that they
must follow in order to be recognized by
the USPTO as a suitable depository.
 Used by recognized depositories to
justify their recognition and to ensure that
they remain in compliance
administratively and technically, that they
hire qualified staff, and that their facilities
are suitably equipped for the storage and
testing of deposits of biological material.
 Used by the USPTO to determine
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.

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.

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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 March 15, 2013 (78 Fed.
Reg. 16472). The comment period ended on May 14, 2013. 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

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and calculates the burden hours and costs of this information collection to the public,
based on the following factors:
a.

Deposited Materials



Respondent Calculation Factors
The USPTO estimates that approximately 2,000 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 5% 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.

Request for Depository Approval



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. This is the historical estimate for
this collection. The agency has not received any public comment to the contrary and
maintains the estimate.
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.

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

Cost Burden Calculation Factors
The USPTO uses a professional rate of $371 per hour for respondent cost burden
calculations, which is the mean rate for attorneys in private firms as shown in the 2011
Report of the Economic Survey, published by the Committee on Economics of Legal
Practice of the American Intellectual Property Law Association (AIPLA).

Table 2: Burden Hour/Burden Cost to Respondents
Item
#

Item

Hours
(a)

1

Deposited Materials
-Samples
-Certification/Viability Statements

1.0

2,000

2,000

$30.00

$60,000.00

2

Request for Depository Approval

5.0

1

5

$371.00

$1,855.00

2,001

2,005

Total

13.

Responses
(yr)
(b)

- - - - -

Burden
(hrs/yr)
(c)
(a) x (b)

Rate
($/hr)
(d)

- - - -

Total Cost
($/hr)
(e)
(c) x (d)

$61,855.00

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 $5,000,000.
In addition, this collection does have 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 $37.50 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 $469.32 per
shipment, for a cost to respondents of $938,640.

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The postage cost for a depository seeking recognition is estimated to be $5.95, 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 $5.95 per depository request, for a rounded cost to
respondents of $6.00.
Table 3 – Annual (Non-hour) Costs to Respondents
Item
#

Item/Type of Cost

Estimated
Annual
Responses

Amount

Totals

FEES
1

Deposited Materials

2

Request for Depository Approval

2,000

$2,500.00

$5,000,000.00

1

$0.00

$0.00

Total Fees

$5,000,000.00

PACKAGING/POSTAGE COSTS
1

Deposited Materials – Federal Express

2,000

$116.50

$233,000.00

1

Deposited Materials – Packaging Supplies

2,000

$352.82

$705,640.00

2

Request for Depository Approval

1

$5.95

$6.00

Total Postage/Packaging

$938,646.00

Total Annual (Non-Hour) Cost Burden

14.

$5,938,646.00

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.

Deposited Materials

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
examiner (on the complex biotechnology scale) is currently $33.60 according to the U.S.
Office of Personnel Management’s (OPM’s) wage chart, including locality pay for the
Washington, DC area. 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 $43.68 ($33.60 +
$10.08).

9

b.

Request for Depository Approval

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 1, is
currently $67.21 according to OPM’s wage chart, including locality pay for the
Washington, DC area. 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 $87.37 ($67.21 +
$20.16).
Table 3 calculates the processing hours and costs associated with this information
collection to the Federal Government:
Table 4: Burden Hour/Burden Cost 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

2,000

500

$43.68

$21,840.00

2

Request for Depository Approval

10.0

1

10

$87.37

$874.00

2,001

510

- - - - -

$22,714.00

Total

15.

- - - - -

Reason for Change in Burden from the Current Inventory

OMB previously approved this information collection in August 2010 with a total of 3,501
responses, 3,505 burden hours, and $9,831,120 in annual (non-hour) costs. There
have been no interim approvals.
Changes in Responses and Burden Hours from the Current Inventory
The USPTO estimates that the total annual responses will be 2,001 and the total annual
burden hours will be 2,005, which is a decrease of 1,500 responses and 1,500 burden
hours from the currently approved burden for this collection. These changes are due to
administrative adjustments from updated annual response estimates.
Table 4a: Changes in Responses and Burden Hours from the Current Inventory
Item
#

Item

1

Deposited Materials

2

Request for Depository Approval
Totals

Currently
Approved
responses

Updated
responses

Change in
responses
(admin.)

3,500

2,000

(1,500)

1

1

3,501

2,001

10

Currently
approved
burden
hours

Updated
burden
hours

Change in
burden
hours
(admin.)

3,500

2,000

(1,500)

0

5

5

0

(1,500)

3,505

2,005

(1,500)

Changes in Annual (Non-hour) Costs from the Current Inventory
The total annual (non-hour) cost burden for this submission of $5,938,646 is a decrease
of $3,892,474 from the currently approved total of $9,831,120. This decrease is due to
administrative adjustments from a decrease in response estimates and updated
mailing/postage rates.
Table 4b: Changes in Annual (Non-hour) Costs from the Current Inventory
Item
#

Cost

Currently
approved annual
cost burden

1&2

Mailing/Postage

$9,831,120.00

Totals

$9,831,120.00

16.

Program
changes

Administrative
adjustments

Total change
in costs

Updated
annual cost
burden

$0.00

$3,892,474.00

$3,892,474.00

$5,938,646.00

$0.00

$3,892,474.00

$3,892,474.00

$5,938,646.00

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.
expiration date is not applicable.
18.

Therefore, the display of the

Exception to the Certificate Statement

This collection of information does not include any exceptions to the certificate
statement.

B.

COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

This collection of information does not employ statistical methods.

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