0651-0024-SupStmt-May2013-update

SUPPORTING STATEMENT
United States Patent and Trademark Office
Requirements for Patent Applications Containing Nucleotide Sequence
and/or Amino Acid Sequence Disclosures
OMB CONTROL NUMBER 0651-0024
(May 2013)

A.

JUSTIFICATION

1.

Necessity of Information Collection

Patent applications that contain nucleotide and/or amino acid sequence disclosures
must include a copy of the sequence listing in accordance with the requirements in 37
CFR 1.821-1.825. The rules of practice require applicants to submit these sequence
listings in a standard international format that is consistent with World Intellectual
Property Organization (WIPO) Standard ST.25 (1998).
Applicants may submit
sequence listings for both U.S. and international patent applications. Submissions of
nucleotide and amino acid sequence listings in international applications are in
accordance with Patent Cooperation Treaty (PCT) Rule 13ter.
The USPTO uses the sequence listings during the examination process to determine
the patentability of the associated patent application. Sequence listings are also
disclosed as part of the published patent application or issued patent.
The sequence listing required by 37 CFR 1.821(c) for U.S. patent applications may be
submitted on paper, compact disc (CD), or through EFS-Web, the USPTO’s online filing
system. Sequence listings for international applications may be submitted on paper or
through EFS-Web only, though sequence listings that are too large to be filed
electronically through EFS-Web may be submitted on a separate CD. Applicants may
use EFS-Web to file a sequence listing online with a patent application or subsequent to
a previously filed application.
Under 37 CFR 1.821(e)-(f), applicants must also submit a copy of the sequence listing
in “computer readable form” (CRF) with a statement indicating that the CRF copy of the
sequence listing is identical to the paper or CD copy required by 1.821(c). If an
applicant later submits an amendment to the paper or CD copy of the sequence listing,
the applicant must also submit a new CRF copy of the amended listing. Applicants may
submit the CRF copy of the sequence listing to the USPTO on CD or other acceptable
media as provided in 37 CFR 1.824. Sequence listings that are submitted online
through EFS-Web in the proper text format do not require a separate CRF copy or the
associated statement.
If the CRF sequence listing in a new application is identical to the CRF sequence listing
of another application that the applicant already has on file at the USPTO, 37 CFR
1.821(e) permits the applicant to refer to the CRF listing in the other application rather

than having to submit a duplicate copy of the CRF listing for the new application. In
such a case, the applicant may submit a letter identifying the application and CRF
sequence listing that is already on file and stating that the sequence listing submitted in
the new application is identical to the CRF copy already filed with the previous
application. The USPTO provides a form, Request for Transfer of a Computer
Readable Form Under 37 CFR 1.821(e) (PTO/SB/93), in order to assist customers in
submitting this statement.
This information collection contains the sequence listings that are submitted with
biotechnology patent applications. Information pertaining to the filing of the initial patent
application itself is collected under OMB Control Number 0651-0032, and international
applications submitted under the Patent Cooperation Treaty (PCT) are covered under
OMB Control Number 0651-0021.
Table 1 provides the specific statute and regulations authorizing the USPTO to collect
the information discussed above:
Table 1: Information Requirements
Requirement

Statute

Rule

1

Sequence Listing in Application and Electronic Sequence
Listing in Application

35 U.S.C. § 22

37 CFR 1.821-1.825

2

Request for Transfer of a Computer Readable Form
Under 37 CFR 1.821(e)

35 U.S.C. § 22

37 CFR 1.821-1.825

2.

Needs and Uses

The USPTO uses nucleotide and amino acid sequence listing information to determine
the patentability of an application during the examination process and to support the
publication of issued patents. Upon publication of the application or issued patent, the
associated nucleotide or amino acid sequence listings are disclosed to the public and
made available on the USPTO Web site. Copies of published sequence listings are
forwarded to the National Center for Biotechnology Information (NCBI). Applicants use
the sequence data when preparing both national and international patent applications
involving nucleotide or amino acid sequences.
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 2 outlines how this collection of information is used by the public and the USPTO:

2

Table 2: Needs and Uses

1

Item

Form #

Needs and Uses

Sequence Listing in
Application (paper)

No Form
Associated






2

Sequence Listing in
Application (CD)

No Form
Associated







3

Electronic Sequence Listing
in Application

No Form
Associated






4

Request for Transfer of a
Computer Readable Form
Under 37 CFR 1.821(e)

PTO/SB/93




3.

Used by the public when preparing a U.S. or international patent
application containing nucleotide and/or amino acid sequence
information.
Used by the USPTO to determine the patentability of an application.
Used by the USPTO to support publication of applications and issued
patents.
Used by the USPTO to participate with the European and Japanese
Patent Offices in a Trilateral Sequence Exchange Project to facilitate
the international exchange of published sequence data.
Used by the public when preparing a U.S. patent application containing
nucleotide and/or amino acid sequence information.
Used by the public when preparing an international patent application
containing nucleotide and/or amino acid sequence information that is
too large to submit electronically over the Internet.
Used by the USPTO to determine the patentability of an application.
Used by the USPTO to support publication of applications and issued
patents.
Used by the USPTO to participate with the European and Japanese
Patent Offices in a Trilateral Sequence Exchange Project to facilitate
the international exchange of published sequence data.
Used by the public to submit a nucleotide and/or amino acid sequence
listing electronically with a U.S. national or international patent
application or subsequent to a previously filed application.
Used by the USPTO to determine the patentability of an application.
Used by the USPTO to support publication of applications and issued
patents.
Used by the USPTO to participate with the European and Japanese
Patent Offices in a Trilateral Sequence Exchange Project to facilitate
the international exchange of published sequence data.
Used by the public to indicate that a CRF sequence listing in a new
application is identical to a CRF sequence listing that is already on file
at the USPTO.
Used by the USPTO to transfer a copy of an existing CRF sequence
listing to a new application.

Use of Information Technology

Applicants may submit sequence listings on paper, CD, or electronically over the
Internet. Submissions on CD must follow the guidelines specified in 37 CFR 1.52(e),
with the file contents in American Standard Code for Information Interchange (ASCII)
format, and be accompanied by the necessary transmittal documentation to identify,
maintain, and interpret the sequence listing. Applicants who submit a paper or CD
sequence listing are also required to submit a CRF copy of the listing, which facilitates
the ability of examiners to search sequences and improves the accuracy and efficiency
of the publishing process. Due to PCT guidelines, sequence listings for international
applications may not be submitted on CD, except for oversized listings that are too large
to submit online as detailed below.
Applicants may submit sequence listings to the USPTO electronically through EFSWeb, the USPTO’s online patent application and document submission system that
allows customers to file patent applications and associated documents through their
3

standard Web browser. Filers should prepare sequence listings in the proper ASCII text
format and then upload them using the secure EFS-Web interface. EFS-Web will
display a warning if the sequence listing does not conform to the proper format.
EFS-Web offers many potential benefits to filers. The system immediately sends
customers an electronic receipt and ensures that electronic sequence listings are
transmitted securely to the USPTO. The electronic filing of sequence listings also
eliminates the inefficiencies of physically mailing, handling, routing, and storing
sequence listings on paper or portable electronic media. Sequence listings submitted in
the proper text format using EFS-Web do not incur any fees and do not require a
separate CRF copy or any paper documentation.
Sequence listing files that exceed 100 megabytes may not be submitted online via EFSWeb. These oversized sequence listings should be copied onto CD for submission to
the USPTO by mail. Customers are advised to keep a back-up copy of the CD and
transmittal information for their own records, and they may also submit a second copy of
the CD to the USPTO to be used in case the first copy is unreadable. The acceptance
of CDs and electronic submissions is permitted by 35 U.S.C. § 22, which provides that
the USPTO “may require papers filed in the Patent and Trademark Office to be printed,
typewritten, or on an electronic medium.”
The USPTO provides free PatentIn authoring software that may be used by applicants
to create sequence listings that comply with U.S. and international filing standards for
biotechnology patent applications containing nucleotide and amino acid sequence data.
The PatentIn software may be downloaded from the USPTO Web site, and the USPTO
offers in-person and online training on how to use the software. In addition, the USPTO
provides a CRF Checker software tool that allows applicants to test sequence listings
for compliance with format and content rules before submitting them to the USPTO.
Use of the Checker utility reduces the number of sequence listings that the USPTO
must return to customers for correction of errors.
When the sequence listing arrives at the USPTO, the data format is checked for
compliance by the CRF receipt system and then uploaded to the Automated
Biotechnology Sequence Search (ABSS) System database. ABSS stores electronic
sequence listings submitted by applicants and supports searching of biosequences from
patent submissions as well as public and commercial databases of published
biosequence data. ABSS also supports the publication and dissemination of sequence
listings following publication of the associated application or issuance of the patent.
Upon publication of the application or issued patent, the associated nucleotide or amino
acid sequence listings are disclosed to the public. Sequence listings that are extremely
long (files larger than 600K or approximately 300 printed pages) are published only in
electronic form and are available for public viewing or download through the Publication
Site for Issued and Published Sequences (PSIPS) on the USPTO Web site
4

(http://seqdata.uspto.gov). Shorter sequence listings are available through the standard
patent and application search systems on the USPTO Web site.
Information technology system improvements can provide an opportunity to reduce the
burdens associated with USPTO information collections. For example, the USPTO
recognizes that it may be possible for it to revise the format by which an applicant
makes a statement regarding the inclusion of a sequence listing in a patent application,
and to modify how a pre-grant publication or patent references the presence of the
sequence listing. Such revisions and modifications, however, would require significant
changes to the USPTO’s information technology systems (as well as regulatory
changes), and, at present, are not the most effective use of available resources. The
agency plans to revisit the information technology issue, as well as any associated
adjustments to the rules of practice.
4.

Efforts to Identify Duplication

This collection requires the duplication of a limited amount of identifying information
(such as the applicant’s name, address, and phone number), which is also provided on
the patent application. However, the duplication of identification information is the most
efficient way of accurately associating the sequence listing with the appropriate
application case file.
For sequence listings that are submitted on paper or CD, the applicant must also submit
a separate CRF copy of the listing. However, if the applicant already has an identical
CRF sequence listing on file at the USPTO for another application, the applicant may
submit a statement referencing the CRF listing already on file rather than having to
submit a duplicate copy of the CRF listing for the new application. The USPTO
provides a form, Request for Transfer of a Computer Readable Form Under 37 CFR
1.821(e) (PTO/SB/93), in order to assist customers in submitting this statement.
5.

Minimizing Burden to Small Entities

Although the collection may involve small businesses or other small entities, most
applications involving sequence listings are filed by other than small entities. This
collection does not impose a significant economic impact on small businesses or other
small entities. The same information is required from every applicant and is not
available from any other source.
The information collection does involve payment of fees by customers who may qualify
as small entities. To reduce this cost burden for small entities, the USPTO offers
reduced application size fees (by 50%) for persons, small business concerns, or
nonprofit organizations that qualify as small entities under 37 CFR 1.27. No significant
burden is placed on small entities, in that small entities are simply required to identify
themselves as such in order to obtain these benefits. An assertion of small entity status
only needs to be filed once in an application or patent.
5

6.

Consequences of Less Frequent Collection

This collection of information is required for the processing and examination of the
respondent's patent application involving a nucleotide or amino acid sequence listing.
This information could not be collected less frequently. If the information were not
collected, the USPTO could not properly examine the associated application as required
by 35 U.S.C. § 131. Further, the collection of this information is necessary in order to
publish the sequence listings accurately as part of the application or patent.
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

A 60-Day Federal Register Notice was published on October 29, 2012 (77 Fed. Reg.
65537). The comment period ended on December 28, 2012. No comments were
received from the public.
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. Their views are expressed in regularly scheduled meetings and considered in
developing proposals for information collection requirements. The USPTO also meets
regularly with groups from whom sequence information is collected, such as BIO, the
Biotechnology subgroup of the American Intellectual Property Law Association, and the
Biotechnology Institute.
9.

Payments or Gifts to Respondents

This information collection does not involve a payment or gift to any respondent.
10.

Assurance of Confidentiality

The 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.
6

12.

Estimate of Hour and Cost Burden to Respondents

Table 3 calculates the burden hours and costs of this information collection to the
public, based on the following factors:


Respondent Calculation Factors
The USPTO estimates that it will receive approximately 25,250 responses per
year for this collection, with approximately 27% of these responses submitted by
small entities. Approximately 55% of the total responses for this collection will be
submitted electronically.
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 it will take the public approximately six minutes (0.10
hours) to six hours to gather the necessary information, prepare the form or
sequence listing, and submit it to the USPTO.
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 or like
information.



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).
The USPTO estimates that a sequence listing will take approximately five hours
of paraprofessional time at an estimated rate of $122 per hour and one hour of
attorney time at $371 per hour, for a weighted average rate of $163.50 per hour
for preparing a sequence listing. The USPTO expects that the Request for
Transfer of a CRF will be prepared by a paraprofessional at an estimated rate of
$122 per hour.

7

Table 3: Burden Hour/Burden Cost to Respondents
Item

Hours
(a)

Responses
(yr)
(b)

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

Rate
($/hr)
(d)

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

1

Sequence Listing in Application
(paper)

6.00

8,500

51,000

$163.50

$8,338,500.00

2

Sequence Listing in Application (CD)

6.00

500

3,000

$163.50

$490,500.00

3

Electronic Sequence Listing in
Application

6.00

14,000

84,000

$163.50

$13,734,000.00

4

Request for Transfer of a Computer
Readable Form Under 37 CFR
1.821(e) (PTO/SB/93)

0.10

2,250

225

$122.00

$27,450.00

..........

25,250

138,225

........

$22,590,450.00

Totals

13.

Total Annual (Non-hour) Cost Burden

The total annual (non-hour) respondent cost burden for this collection is calculated in
Table 4 below. This collection has no capital start-up or recordkeeping costs.
Fees


In accordance with 35 U.S.C. § 41(a)(1)(G), the USPTO only charges a fee for
submitting a sequence listing as part of a U.S. application or as part of an
international application entering the U.S. national stage if the sequence listing (i)
is not filed via EFS-Web or not filed on an electronic medium in compliance with
§§ 1.52(e) and 1.821(c) or (e), and (ii) causes the application to exceed 100
pages. (See 37 CFR 1.52(f).) Under 37 CFR 1.16(s) and 1.492(j) for U.S.
applications and international applications entering the U.S. national stage,
respectively, if the application, including the sequence listings filed on paper or
on a non-compliant electronic medium, exceeds 100 pages, the application size
fee is $320 (or $160 for small entities) for each additional 50 pages or fraction
thereof. The USPTO estimates that approximately 250 applications from large
entities with long sequence listings filed on paper or on a non-compliant
electronic medium will incur an average application size fee of $960, and
approximately 200 applications from small entities with long sequence listings
filed on paper or on a non-compliant electronic medium will incur an average
application size fee of $480.



As a Receiving Office, the USPTO collects the international filing fee for each
international application it receives. The basic international filing fee only covers
the first 30 pages of the international application. As a result, a $16 fee per page
is added to the international filing fee for each page over 30 pages of an
international application including a sequence listing filed on paper or in PDF
8

format. No page fees are triggered by sequence listings that are submitted via
EFS-Web in the proper text format. The average length of a sequence listing
filed on paper or in PDF format in an international application is 150 pages, which
would carry an additional fee of $2,400 if the international application were
already at least 30 pages long without the listing. The USPTO estimates that
approximately 900 of the 8,500 sequence listings filed per year on paper or in
PDF format will be for international applications.
Postage
Mailed submissions may include the sequence listing on either paper or CD, the CRF
copy of the listing on CD, and a transmittal letter containing the required identifying
information. The USPTO estimates that the average postage cost for a paper or CD
sequence listing submission will be $5.60 (USPS Priority Mail, flat rate envelope) and
that 9,000 sequence listings will be mailed to the USPTO per year.
Table 4: Annual (Non-hour) Cost Burden
Type of Cost

Estimated
Annual
Responses

Amount

Totals

Size fees under 37 CFR 1.16(s) and 1.492(j), large entity

250

$960.00

$240,000.00

Size fees under 37 CFR 1.16(s) and 1.492(j), small entity

200

$480.00

$96,000.00

Size fees for international applications

900

$2,400.00

$2,160,000.00

Total Fees

-----

-----

$2,496,000.00

9,000

$5.60

$50,400.00

Total Postage

-----

-----

$50,400.00

Total Annual (Non-hour) Cost Burden

-----

-----

$2,546,400.00

Postage for paper or CD sequence listing submissions

14.

Annual Cost to the Federal Government

Sequence disclosures are processed in two stages. The USPTO estimates that the first
stage takes approximately 8 minutes of processing time by a GS-6, step 1 employee,
and that the second stage takes approximately 16 minutes of processing time by a GS12, step 1 or GS-13, step 1 employee, for a total of 24 minutes (0.40 hours) of
processing time per response. The hourly rate for a GS-6, step 1 employee is currently
$18.20, and the average hourly rate of a GS-12, step 1 ($35.88) and GS-13, step 1
($42.66) is currently $39.27, which results in a weighted average hourly rate of $32.25
and an estimated cost of $41.93 per hour ($32.25 with 30% ($9.68) added for benefits
and overhead) for processing the sequence disclosures.

9

The USPTO estimates that it takes a GS-6, step 1 employee an average of 8 minutes
(0.13 hours) to process a Request for Transfer of a CRF at an estimated cost of $23.66
per hour (GS hourly rate of $18.20 with 30% ($5.46) added for benefits and overhead).
Table 5 calculates the burden hours and costs to the Federal Government for
processing this information collection:
Table 5: Burden Hour/Burden Cost to the Federal Government
Item

Hours
(a)

Responses
(yr)
(b)

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

Rate
($/hr)
(d)

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

1

Sequence Listing in Application (paper)

0.40

8,500

3,400

$41.93

$142,562.00

2

Sequence Listing in Application (CD)

0.40

500

200

$41.93

$8,386.00

3

Electronic Sequence Listing in Application

0.40

14,000

5,600

$41.93

$234,808.00

4

Request for Transfer of a Computer
Readable Form Under 37 CFR 1.821(e)
(PTO/SB/93)

0.13

2,250

293

$23.66

$6,932.00

........

25,250

9,493

.........

$392,688.00

Totals

15.

Reasons for Changes in Burden from the Current Inventory

OMB previously approved this information collection in February 2010 with a total of
19,750 responses, 103,750 burden hours, and $920,959 in annual (non-hour) costs.
There have been no interim approvals.
Changes from the 60-Day Federal Register Notice to the Current Submission
The USPTO has updated the estimated postage cost for mailed submissions from
$5.15, as published in the 60-Day Federal Register Notice, to $5.60 due to the USPS
rate changes that are effective on January 27, 2013. Consequently, the total annual
(non-hour) cost burden for this renewal has been revised from the $2,542,350 published
in the 60-Day Federal Register Notice to $2,546,400.
Changes in Responses and Burden Hours from the Current Inventory
For this renewal, the USPTO estimates that the total annual responses will be 25,250
and the total annual burden hours will be 138,225, which is an increase of 5,500
responses and 34,475 burden hours from the currently approved burden for this
collection. These increases are due to administrative adjustments from updated annual
response estimates. There are no program changes.

10

Table 6a: Changes in Responses and Burden Hours from the Current Inventory
Item

Currently
approved
responses

Updated
responses

Change in
responses
(admin.)

Currently
approved
burden
hours

Updated
burden
hours

Change in
burden
hours
(admin.)

1

Sequence Listing in Application
(paper)

3,450

8,500

5,050

20,700

51,000

30,300

2

Sequence Listing in Application
(CD)

865

500

(365)

5,190

3,000

(2,190)

3

Electronic Sequence Listing in
Application

12,935

14,000

1,065

77,610

84,000

6,390

4

Request for Transfer of a Computer
Readable Form Under 37 CFR
1.821(e) (PTO/SB/93)

2,500

2,250

(250)

250

225

(25)

19,750

25,250

5,500

103,750

138,225

34,475

Totals

Changes in Annual (Non-hour) Costs from the Current Inventory
The total annual (non-hour) cost burden for this submission of $2,546,400 is an
increase of $1,625,441 from the currently approved total of $920,959. This increase is
due to program changes and administrative adjustments.
Program changes


Fees: Increased in part due to increases in size fee amounts from the previous
renewal.



Capital start-up: Removed costs associated with submitting CDs since blank
media and padded envelopes are standard business supplies.



Recordkeeping: Removed costs associated with retaining back-up copies of CDs
and acknowledgment receipts from online submissions because keeping these
items is a suggestion and not a requirement.

Administrative adjustments


Fees: Increased in part due to increases in estimated responses that incur size
fees.



Postage: Increased due to increases in estimated number of mailed responses
and increases in USPS postage rates since the previous renewal.

11

Table 6b: Changes in Annual (Non-hour) Costs from the Current Inventory
Cost

Currently approved
annual cost burden

Administrative
adjustments

Program
changes

Total change
in costs

Updated
annual cost
burden

$876,675.00

$1,161,825.00

$457,500.00

$1,619,325.00

$2,496,000.00

1

Fees

2

Capital start-up

$11,225.00

$0.00

($11,225.00)

($11,225.00)

$0.00

3

Recordkeeping

$11,700.00

$0.00

($11,700.00)

($11,700.00)

$0.00

4

Postage

$21,359.00

$29,041.00

$0.00

$29,041.00

$50,400.00

$920,959.00

$1,190,866.00

$434,575.00

$1,625,441.00

$2,546,400.00

Totals

16.

Project Schedule

The USPTO does not plan to publish this information for statistical use. However,
sequence listing information will be published as part of the routine pre-grant publication
of applications as well as issued patents.
17.

Display of Expiration Date of OMB Approval

The form in this information collection will display the OMB Control Number and the
expiration date of OMB approval.
18.

Exception to the Certificate Statement

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

B.

COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS

This collection of information does not employ statistical methods.

12