0022 Just 2010

SUPPORTING STATEMENT
United States Patent and Trademark Office
Deposit of Biological Materials
OMB CONTROL NUMBER 0651-0022
(July 2010)

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.

Deposits of Biological Materials

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
the 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 Depository 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.
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 Depository Authority (IDA).
b.

Depositories

Depositories are required by 37 CFR 1.803 to demonstrate 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 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.

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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.
Table 1 provides the specific statutes and rules requiring the USPTO to collect the
information discussed above:
Table 1: Information Requirements for the Deposit of Biological Materials
Requirement

Statute

Rule

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

Depositories

35 U.S.C. 2(b)(2)

37 CFR 1.803

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 comply with all applicable information quality guidelines, i.e.,
OMB and specific operating unit guidelines.
This proposed collection of information would result in information that will be collected,
maintained, and used in a way consistent with all applicable OMB and USPTO
Information Quality Guidelines (See Ref. A).
Table 2 outlines how this information is collected and used by the USPTO and by the
public. No forms are associated with this collection.

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Table 2: Needs and Uses for the Deposit of Biological Materials
Requirement

Form #

Deposit of Biological Materials

No Form
Associated

• Used by the applicant to determine whether to file for a new patent.
• Used by the patentee to maintain enforceability of a patent.
• Used by the USPTO to establish enablement of claimed biological
materials.
• Used by the USPTO to establish possession of the invention for priority
purposes.

Depositories

No Form
Associated

• 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.

3.

Needs and Uses

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

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USPTO could not comply with the requirements of 35 U.S.C. 2(b)(2) and 37 CFR 1.8011.809.
7.

Special Circumstances in the Conduct of Information Collection

There are no special circumstances associated with this collection of information.
8.

Consultation Outside the Agency

The 60-Day Notice was published in the Federal Register on February 9, 2010 (71 Fed
Reg. 6348). The comment period ended on April 12, 2010. No public comments were
received.
The USPTO has long-standing relationships with groups from who patent application
data is collected, such as the American Intellectual Property Law Association (AIPLA),
as well as patent bar associations, inventor groups, and users of our public facilities.
Their views are expressed in regularly scheduled meetings and considered in
developing proposals for information collection requirements. There have been no
comments or concerns expressed by these or similar organizations concerning the time
required to provide the information under this program.
9.

Payment or Gifts to Respondents

This information collection does not involve a payment or gift to any respondent.
Response to this information collection is necessary to obtain a patent or to obtain
status as a suitable depository.
10.

Assurance of Confidentiality

Confidentiality of patent applications is governed by 35 U.S.C. 122 and 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. The disclosure of the invention in the application is the quid pro quo for the
property right conferred by the patent grant and the very means by which the patent
statute achieves its constitutional objective of “promot[ing] the progress of sciences and
useful arts.” The prosecution history contained in the application file is critical to
determining the scope of the property right conferred by the patent grant.
11.

Justification for Sensitive Questions

None of the required information is considered to be of a sensitive nature.

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12.

Estimate of Hour and Cost Burden to Respondents

For clarity, the burden explanations have been separated into sections a. and b. Table
4 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 3,500 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.

•

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.

•

Cost Burden Calculation Factors
The USPTO expects that a senior administrative assistant, at a rate of $30 per hour,
would prepare this information. This is a fully-loaded hourly rate.

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.

•

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.

•

Cost Burden Calculation Factors
In 2009 the Committee on Economics of Legal Practice of the American Intellectual
Property Law Association (AIPLA) published a report that summarized the results of a
survey with data on hourly billing rates. The professional rate of $325 per hour used in
this submission is the median rate for attorneys in private firms as published in that
report. The USPTO expects that the information in this collection will be prepared by
attorneys. This is a fully-loaded hourly rate.

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Table 4: Burden Hour/Burden Cost to Respondents for the Deposit of Biological Materials
Item

Hours
Per
Application
(a)

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

Responses
(yr)
(b)

Rate
($/hr)
(d)

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

Deposited Materials

1.0

3,500

3,500

$30.00

$105,000.00

Depository Approval

5.0

1

5

$325.00

$1,625.00

3,501

3,505

Total

13.

- - - - -

- - - -

$106,625.00

Total Annualized (Non-hour) Cost Burden

There are no maintenance or record keeping costs, or filing fees associated with this
information collection. There are, however, capital start-up and mailing 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 ATCC Bioscience Laboratory Services listing, which includes their requirements
along with a fee and payment schedule, is furnished (Ref. B).
The USPTO estimates that approximately 3,500 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. The USPTO estimates that the total non-hour
respondent cost burden in the form of capital start-up costs amounts to $8,750,000
($2,500 x 3,500).
In addition, this collection does have mailing 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 $32.50 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 $2.20. 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 $199.19 per package of four for specimen shipments
requiring refrigeration or dry ice. Therefore, postage costs average $308.89 per
shipment, for a cost to respondents of $1,081,115 ($308.89 x 3,500).

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The postage cost for a depository seeking recognition is estimated to be $4.80, 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 $4.80 per depository request, for a rounded cost to
respondents of $5.00.
The USPTO estimates that the (non-hour) respondent cost burden in the form of mailing
costs amounts to $1,081,120 ($1,081,115 + $5).
Therefore, the USPTO estimates that the total (non-hour) respondent cost burden for
this collection in the form of depository fees ($8,750,000) and mailing costs
($1,081,120) amounts to $9,831,120.
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 5 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
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).
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 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 5 calculates the processing hours and costs associated with this information
collection to the Federal Government:

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Table 5: Burden Hour/Burden Cost to the Federal Government for the Deposit of Biological
Materials
Item

Hours
(a)

Responses
(yr)
(b)

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

Rate
($/hr)
(d)

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

Deposited Materials

0.25

3,500

875

$43.68

$38,220.00

Depository Approval

10.0

1

10

$87.37

$874.00

3,501

885

- - - - -

$39,094.00

Total

15.

- - - - -

Reason for Change in Burden

Summary of Changes Since the Previous Renewal
This collection was previously approved by OMB on August 7, 2007, with a total of
3,501 responses and 3,501 burden hours. With this renewal, the USPTO estimates that
the annual responses and burden hours will remain the same.
The total annualized (non-hour) cost burden for this renewal of $9,831,120 is an
increase of $4 from the currently approved total of $9,727,116. The increase is due to
an increase in postage costs, as an administrative adjustment.
Change in Respondent Cost Burden
When this collection was approved by OMB in August 2007, the estimated hourly rate
for attorneys was $304. Using that rate and the paraprofessional rate of $30 for a
senior administrative assistant, the reported 3,501 burden hours yielded a respondent
cost burden of $105,380.
For this renewal, the USPTO is using the current hourly rate for attorneys of $325. At
this rate and the administrative rate of $30, the 3,501 burden hours yield a respondent
cost burden of $106,625, which is an increase of $1,245 over the currently approved
burden. This increase in respondent cost burden is due to the increase in the estimated
hourly professional rate.
Changes in Annualized (Non-hour) Cost Burden
The USPTO estimates that the total annual (non-hour) cost burden will increase by $4
for this renewal, from $9,831,116 currently reported on the OMB inventory to the
present $9,831,120. The increase is due to an increase in postage costs. Therefore,
this collection has an increase in annual (non-hour) cost burden of $4 due to an
administrative adjustment.

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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.
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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References
A.
B.

USPTO Information Quality Guidelines
American Type Culture Collection (ATCC) Bioscience Laboratory Services listing,
requirements, and fees and payment schedule for patent deposits.

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