0651-0024-JustStmt-2009-final

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

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. Sequence listings that are
extremely long (files larger than 600K or approximately 300 printed pages) are published
only in electronic form and are available to the public on the USPTO sequence data Web
page.
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 is
proposing to add a new form to this collection, 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 PCT are covered under OMB Control Number 0651-0021.
Table 1 provides the specific statute and regulations requiring the USPTO to collect the
information discussed above:
Table 1: Information Requirement for Sequence Disclosures
Requirement

Statute

Rule

Sequence Listing in Application and Electronic Sequence
Listing in Application

35 U.S.C. ' 22

37 CFR 1.821-1.825

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. In addition, the sequences are 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. 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 also 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 comply with all applicable information quality guidelines, i.e. OMB and
specific operating unit guidelines.
This proposed collection of information will result in information that will be collected,
maintained, and used in a way consistent with all applicable OMB and USPTO Information
Quality Guidelines.
2

Table 2 outlines how this collection of information is used by the public and the USPTO:
Table 2: Needs and Uses of Information Collected for Sequence Disclosures
Item

Form #

Needs and Uses

Sequence Listing in Application
(paper)

No Form
Associated

C
C
C
C

Sequence Listing in Application
(CD)

No Form
Associated

C
C
C
C
C

Electronic Sequence Listing in
Application (EFS-Web)

No Form
Associated

C
C
C
C

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

PTO/SB/93

C
C

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
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 recent changes in 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.
3

Applicants may submit sequence listings to the USPTO online through EFS-Web, the
USPTO’s web-based patent application and document submission system that allows
customers to file patent applications and associated documents electronically through their
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
Amay 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 public training sessions on how to use the software. Training is available in-person
and online via Web cast. 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
4

long (files larger than 600K or approximately 300 printed pages) are published only in
electronic form and are available for viewing or download through the Publication Site for
Issued and Published Sequences (PSIPS) on the USPTO Web site. Shorter sequence
listings are available through the standard patent and application search systems on the
USPTO Web site.
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 has developed a
new 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.
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.
5

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 August 11, 2009 (74 Fed.
Reg. 40163). The comment period ended on October 13, 2009. Five commenters
(including individual patent practitioners, industry, and the general public) responded to the
August 11, 2009 60-Day Notice. The USPTO’s responses to the comments follow
(comments that are generally favorable are not discussed):
Comment 1: Four commenters indicated that the USPTO has underestimated the time and
level of skill required to gather the necessary information, prepare the sequence listing, and
submit it to the USPTO.
Response: The USPTO notes the concerns expressed by the commenters regarding the
time and level of skill required to gather the necessary information, prepare the sequence
listing, and submit it to the USPTO. In response to those concerns, the USPTO in this
Supporting Statement has revised its estimate for the amount of time and level of skill
required to gather the necessary information, prepare the sequence listing, and submit it to
the USPTO, as shown in greater detail at Table 3 below.
Comment 2: One commenter noted the possibility of improving the ability of PatentIn to
import sequences from a FASTA or other standard format. The commenter also
recommended that the USPTO work with the National Center for Biotechnology Information
(NCBI) on sequence listing entry.
Response: The USPTO is grateful for the comments regarding PatentIn and sequence
listing entry. The USPTO regularly evaluates all options for improving PatentIn and
sequence listing entry, and will take the present comments under advisement.
Comment 3: One commenter suggested that the fees charged for sequence listings should
be based on the number of sequences, number of characters, or number of pages.
Response: 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 EFSWeb 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
$270 (or $135 for small entities) for each additional 50 pages or fraction thereof.
6

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 $13 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 format. No page fees are triggered by sequence listings that
are submitted via EFS-Web in the proper text format.
Comment 4: One commenter indicated that the primary focus on collection of sequence
information appears to be on “coded amino acid sequences,” made by translation of
mRNA, since any sequences containing D-amino acids are specifically excluded and any
“non-coded amino acid” is listed as “Xaa,” with its identity only disclosed in the features
section of the listing. The commenter further stated that the current rules are both
underinclusive, because they do not capture any information that can be meaningfully
searched as to the identity of “non-coded amino acids,” and overinclusive by requiring
disclosure of amino acid sequences made by chemically synthetic means. The commenter
concluded that the information collected is of little or no practical utility except in the case of
sequences consisting solely of “coded amino acids.”
Response: The international standard for sequence listings was established based upon
the conventions used in public databases with regard to residue abbreviations in
sequences. The current rules, 37 CFR 1.821 - 1.825, are consistent with World Intellectual
Property Organization (WIPO) Standard ST.25 (signed in 1998 and effective July 1, 1998),
and sequence listings prepared in accordance with those rules generally will be acceptable
in all countries which adhere to that standard. One response to comments in the
“Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid
Disclosures,” 63 Fed. Reg. 29620-29643 (June 1, 1998), indicated that sections 1.821 –
1.825 do not require any information to be disclosed in the form of a sequence, but rather
require a particular format whenever information is presented in the form of a sequence.
The general public is assured that patents which contain sequence information contain the
sequence information in the sequence listing and the sequences are available in a
computer accessible form. The June 1, 1998 publication further indicated that because the
sequence databases did not include D-amino acids in sequences at that time, submission
of those sequences containing D-amino acids was not made mandatory; however,
voluntary submissions of protein sequences containing D-amino acids would be accepted.
A search of a sequence containing an amino acid listed as “Xaa,” where the modified or
unusual amino acid is described in the features section of the sequence listing, can
potentially produce references useful in the determination of whether a claimed sequence
may be considered obvious. Many synthetic sequences containing unusual residues are
homologs (similar sequences) or analogs of natural sequences or fragments of natural
sequences (template). A search query of the template may identify prior art that discloses
the template sequence and discusses such homologs or analogs.

7

Comment 5: One commenter recommended that the USPTO Checker software be updated
to alert users to the same potential errors that are caught by the Office’s internal sequence
checking software.
Response: The USPTO thanks the commenter for his recommendation regarding the
USPTO Checker software. However, experience over the past two years reveals a very
limited number of times in which errors were caught by the Office’s internal sequence
checking software that were not caught by Checker. In addition, the USPTO provides User
Notes
for
Checker
at
the
Web
page
http://www.uspto.gov/patents/resources/tools/checker/chkrnote.jsp. Experience over the
past two years reveals that a majority of the errors involving Checker could have been
avoided by familiarity with the provided User Notes.
Comment 6: One comment indicated that additionally requested information, such as the
name of the organism and repetition of client identification and inventor names is not
necessary.
Response: A sequence listing is stored and published in a database that is separate from
the remainder of the application; therefore, the referenced identifying information is a
necessary part of the listing.
Comment 7: One comment indicated that a sequence listing should be required only for
sequences that are claimed or substantially likely to be claimed.
Response: As noted in the response to comments in the “Requirements for Patent
Applications Containing Nucleotide Sequence and/or Amino Acid Disclosures,”
63 Fed. Reg. 29620-29643 (June 1, 1998), sections 1.821 – 1.825 do not require any
information to be disclosed in the form of a sequence, but rather require a particular format
whenever information is presented in the form of a sequence. Requiring the particular
format for both unclaimed and claimed information presented in the form of a sequence
serves the important purpose of building the Office’s prior art database.
Comment 8: One comment indicated that a statement indicating that the paper copy and
the electronic copy of the sequence listing are identical should not be required, but rather a
checkbox could be added to the transmittal letter.
Response: When an application is filed electronically via EFS-Web with the sequence
listing in text format, the sequence listing serves both as part of the application and as the
computer readable form for search purposes. No statement is required under these
circumstances. When an application is filed in paper, an indication that the sequence
listings are identical is still necessary. The Office will take under advisement the
suggestion to provide for a checkbox.

8

Comment 9: One comment indicated that the sequence listing should be considered part of
the specification, rather than requiring a preliminary amendment or incorporation by
reference.
Response: The sequence listing is considered part of the application as originally filed. The
incorporation by reference statement is needed to notify the public that a sequence listing is
part of the application because the Office does not publish the full text of all sequence
listings for patents or patent application publications.
Comment 10: One comment indicated that an easier way to list unusual amino acids or
nucleotides should be provided.
Response: The international standard for sequence listings was established based upon
the conventions used in public databases with regard to residue abbreviations in
sequences. The World Intellectual Property Organization (WIPO) Standard ST.25 was
signed in 1998, became effective July 1, 1998, and has not been changed since that time.
The current U.S. rules are consistent with that standard and will not be changed until such
time as ST.25 is modified.
Comment 11: One comment indicated that a better software program should be provided
for preparation of sequence listings that could accept both three and one letter amino acid
codes.
Response: This change will be made once funds are available for a software update.
Comment 12: One comment indicated that the patent examiner should explain how to
correct errors in a sequence listing, and if the correction is simple, correct it by examiner’s
amendment.
Response: Sequence listings are reviewed for compliance prior to receipt of the application
by the examiner. An error report is provided together with the notice to comply with the
sequence requirements. Correction cannot be made simply by examiner’s amendment,
since a corrected electronic copy is required for search and publication purposes.
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

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. 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 science and
useful arts.” The prosecution history contained in the application file is critical for
determining the scope of the property right conferred by a patent grant.
11.

Justification for Sensitive Questions

None of the required information in this collection is considered to be of a sensitive nature.
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 19,750 responses per year for this collection.

$

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.

$

Cost Burden Calculation Factors
In 2009 the Committee on Economics of Legal Practice of the American Intellectual Property
Law Association published a report that summarized the results of a survey with data on
hourly billing rates. The professional rate of $325 per hour is the median rate for attorneys
in private firms as published in that report. The USPTO estimates that a sequence listing
will take approximately five hours of paraprofessional time at an estimated rate of $100 per
hour and one hour of attorney time at $325 per hour, for a weighted average rate of $137.50
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 $100 per
hour. These are fully-loaded hourly rates.

10

Table 3: Burden Hour/Burden Cost to Respondents for Sequence Disclosures
Item

Hours
(a)

Responses
(yr)
(b)

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

Rate
($/hr)
(d)

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

Sequence Listing in Application (paper)

6.00

3,450

20,700

$137.50

$2,846,250.00

Sequence Listing in Application (CD)

6.00

865

5,190

$137.50

$713,625.00

Electronic Sequence Listing in Application
(EFS-Web)

6.00

12,935

77,610

$137.50

$10,671,375.00

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

0.10

2,500

250

$100.00

$25,000.00

..........

19,750

103,750

. . . . .. . . .

$14,256,250.00

Totals

The USPTO estimates that approximately 65% of the total responses for this collection will
be submitted electronically through EFS-Web.
13.

Total Annualized Cost Burden

There are no maintenance costs associated with this collection. The USPTO provides free
software for creating and validating the format of sequence listings prior to submission.
However, this collection does have annual (non-hour) costs in the form of fees, capital startup costs, recordkeeping costs, and postage costs.
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 $270 (or
$135 for small entities) for each additional 50 pages or fraction thereof. The USPTO
estimates that approximately 120 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 $810, and approximately 95 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 $405, for a total of $135,675 per year.
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 $13 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 format. No page fees are triggered by sequence listings that
11

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 $1,950 if the international application were already at least
30 pages long without the listing. The USPTO estimates that approximately 380 of the
3,450 sequence listings filed per year on paper or in PDF format will be for international
applications, for a total of $741,000 per year in page fees. Therefore, this collection has
a total of $876,675 in fees per year.
There are capital start-up costs associated with submitting sequence listings and CRF
copies to the USPTO on CD. Applicants who submit sequence listings on CD must submit
two copies of the CD (or three copies for international applications) along with a transmittal
letter stating that the copies are identical. This process requires additional supplies,
including blank recordable CD media and padded envelopes for shipping. The USPTO
estimates that the cost of these supplies will be approximately $3 per CD submission and
that it will receive approximately 865 CD submissions per year, for a total of $2,595. In
addition, customers who submit sequence listings on paper or CD must also submit a
separate CRF copy of the listing, which may be submitted on CD. The USPTO estimates
that it will receive approximately 4,315 CRF copies for paper and CD sequence listings at
an estimated cost of $2 per copy, for a total of $8,630. Therefore, this collection has
total capital start-up costs of $11,225 per year.
Applicants who submit sequence listings on CD may also incur recordkeeping costs. The
USPTO advises applicants to retain a back-up copy of CD submissions and associated
documentation for their records. The USPTO estimates that it will take applicants five
minutes to produce a back-up CD copy and two minutes to print copies of documentation,
for a total of seven minutes (0.12 hours) to make a back-up copy of the CD submission.
The USPTO estimates that approximately 865 CD submissions will be received per year,
for a total of 104 hours for making back-up copies. The USPTO expects that these back-up
copies will be prepared by paraprofessionals at an estimated rate of $100 per hour, for a
recordkeeping cost of $10,400 per year.
There are also recordkeeping costs associated with submitting sequence listings online
using EFS-Web. The USPTO recommends that customers print and retain a copy of the
acknowledgment receipt after a successful online submission. The USPTO estimates that
it will take five seconds (0.001 hours) to print a copy of the acknowledgment receipt and
that approximately 12,935 sequence listings per year will be submitted via EFS-Web, for a
total of approximately 13 hours per year for printing this receipt. The USPTO expects that
these receipts will be printed by paraprofessionals at an estimated rate of $100 per hour,
for a recordkeeping cost of $1,300 per year. Therefore, this collection has total
recordkeeping costs of $11,700 per year associated with retaining copies of CDs and
acknowledgment receipts.
Customers may incur postage costs when submitting a sequence listing to the USPTO by
mail. 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
12

information. The USPTO estimates that the average postage cost for a paper or CD
sequence listing submission will be $4.95 and that 4,315 sequence listings will be mailed to
the USPTO per year. Therefore, this collection has total postage costs of $21,359 per
year.
The total annual (non-hour) respondent cost burden for this collection in the form of
fees ($876,675), capital start-up costs ($11,225), recordkeeping costs ($11,700), and
postage costs ($21,359) is estimated to be $920,959 per year.
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 GS-12, 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 $17.77, and the
average hourly rate of a GS-12, step 1 ($35.03) and GS-13, step 1 ($41.65) is currently
$38.34, which results in a weighted average hourly rate of $31.48 for the USPTO staff
processing the sequence disclosures. When 30% is added to account for a fully-loaded
hourly rate (benefits and overhead), the hourly rate for processing these submissions is
$40.92 ($31.48 + $9.44).
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. The hourly rate for a GS-6, step 1 is
currently $17.77. When 30% is added to account for a fully-loaded hourly rate (benefits
and overhead), the hourly rate for processing these submissions is $23.10 ($17.77 +
$5.33).
Table 4 calculates the burden hours and costs to the Federal Government for processing
this information collection:
Table 4: Burden Hour/Burden Cost to the Federal Government for Sequence Disclosures
Item

Hours
(a)

Responses
(yr)
(b)

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

Rate
($/hr)
(d)

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

Sequence Listing in Application (paper)

0.40

3,450

1,380

$40.92

$56,470.00

Sequence Listing in Application (CD)

0.40

865

346

$40.92

$14,158.00

Electronic Sequence Listing in
Application (EFS-Web)

0.40

12,935

5,174

$40.92

$211,720.00

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

0.13

2,500

325

$23.10

$7,508.00

.........

19,750

7,225

..........

$289,856.00

Totals

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15.

Reason for Change in Burden

Summary of Changes Since the Previous Renewal
This information collection was previously approved in December 2006 with a total of
15,382 responses and 17,297 burden hours per year.
For this renewal, the USPTO estimates that the total annual responses will be 19,750 and
the total annual burden hours will be 103,750, which is an increase of 4,368 responses and
86,453 burden hours from the currently approved burden for this collection. This increase
in burden hours is due to both program changes and administrative adjustments. In
addition, the USPTO estimates that the proportion of responses submitted electronically
(using EFS-Web) will increase from approximately 15% to 65%.
The total annual (non-hour) cost burden for this renewal of $920,959 is a decrease of
$3,364,879 from the currently approved total of $4,285,838 in annual costs for this
collection. This decrease in annual costs is due to both program changes and
administrative adjustments.
Changes from the 60-Day Notice
Since the 60-Day Notice was published, the USPTO has decided to revise the time
estimates and respondent cost burden for sequence listing responses, including paper, CD,
and electronic submissions. The USPTO has revised the estimated time for all types of
sequence listing submissions to six hours per response, an increase from the estimates in
the 60-Day Notice of one hour and 20 minutes (paper), 15 minutes (CD), and ten minutes
(EFS-Web). In addition, the USPTO has revised the estimated hourly cost burden for
sequence listing responses from the paraprofessional rate of $100 per hour to a rate of
$137.50 per hour, which is the weighted average of five hours of paraprofessional time and
one hour of attorney time as noted in Section 12 of this Supporting Statement.
As a result of these changes, the total estimated burden hours for this collection have been
increased from what was reported in the 60-Day Notice, from 7,254 to 103,750 burden
hours. In addition, the total estimated respondent cost burden has been increased from
$725,400 to $14,256,250 due to the increase in total estimated burden hours and increased
hourly rate for respondents preparing sequence listings.
Change in Respondent Cost Burden
This collection was previously approved in December 2006 with 17,297 burden hours and
an estimated total respondent cost burden of $1,556,730. That submission used an
estimated rate of $90 per hour for paraprofessionals preparing the sequence listings. For
this renewal, the estimated rate for paraprofessionals has been updated to $100 per hour
and the hourly cost burden for preparing sequence listings has been updated to include a
mixture of both paraprofessionals at an updated rate of $100 per hour and attorneys at a
14

rate of $325 per hour, for a weighted average rate of $137.50 per hour. The total burden
hours for this renewal attributed to sequence listings has also increased to 103,500 due to
overall increases in filings and an increase in the estimated time per response to six hours
for all sequence listings. The 103,500 hours for this renewal attributed to sequence listings
at the revised rate of $137.50 per hour yield a respondent cost burden of $14,231,250. The
addition of the Request for Transfer of a CRF adds $25,000 in respondent cost burden.
Therefore, this renewal has a total respondent cost burden of $14,256,250, which is an
increase of $12,699,520 from the total respondent cost burden reported in the 2006
submission. This increase is due to the overall increase in the total burden hours for this
collection and increases in the estimated hourly rates for respondents.
Changes in Responses and Burden Hours
For this renewal, the USPTO estimates that the annual responses for this collection will
increase by 4,368, from 15,382 to 19,750 responses per year, and that the total burden
hours for this collection will increase by 86,453, from 17,297 to 103,750 hours per year.
This increase in burden hours is due to both program changes and administrative
adjustments, as follows:
!

The USPTO is adjusting the estimated annual responses for paper sequence
listings to 3,450, which is a decrease of 8,062 from the previous estimate of 11,512.
However, the USPTO has also revised the time estimate for preparing a paper
sequence listing submission, increasing the estimate from one hour and 20 minutes
to six hours per response. Therefore, this collection takes a burden increase of
5,389 hours as an administrative adjustment.

!

The USPTO estimates that the annual responses for CD sequence listings will
decrease by 735, from 1,600 to 865, due to expected decreases in filings and recent
changes to PCT guidelines eliminating the submission of sequence listings on CD
as part of an application filed on paper. However, the USPTO has also revised the
time estimate for preparing a CD submission, increasing the estimate from one hour
to six hours per response. Therefore, this collection takes a net burden increase
of 3,590 hours, with a decrease of approximately 200 hours as a program
change being offset by an increase of 3,790 hours as an administrative
adjustment.

!

The USPTO is adjusting the estimated annual responses for sequence listings filed
electronically to 12,935, which is an increase of 10,665 from the previous estimate
of 2,270. The USPTO has also revised the time estimate for preparing an electronic
sequence listing submission, increasing the estimate from ten minutes to six hours
per response. Therefore, this collection takes a burden increase of 77,224
hours as an administrative adjustment.

!

The USPTO estimates that 2,500 Requests for Transfer of a CRF (PTO/SB/93) will
be submitted per year. The USPTO is proposing to add this item to the collection.
15

Therefore, this collection takes a burden increase of 250 hours as a program
change.
In sum, the decrease in paper and CD filings is offset by an increase in electronic filings
using EFS-Web, adjustments to time estimates for all sequence listing responses, and the
addition of the Request for Transfer of a CRF. Therefore, this information collection has
a total burden increase of 86,453 hours, with a net increase of 50 hours due to
program changes and an increase of 86,403 hours due to administrative
adjustments.
Changes in Annual (Non-hour) Costs
For this renewal, the USPTO estimates that the total annual (non-hour) costs for this
collection will decrease by $3,364,879, from $4,285,838 to $920,959 per year. The
decrease in total annual (non-hour) costs is due to both program changes and
administrative adjustments, as follows:
!

This collection is currently approved with $4,184,250 in fees associated with
submitting a sequence listing. For this renewal, the USPTO estimates that these
fees will be $876,675, a decrease of $3,307,575, due to several factors:
Fees for sequence listings submitted in proper text format on CD have been
eliminated, for a decrease of $960,000 from the currently approved collection
as a program change.
Page fees for paper sequence listings for PCT applications have increased from $12
per page to $13 per page, but decreases in the estimated number of paper filings
result in an overall decrease of $2,067,000 from the currently approved collection,
with an increase of $57,000 as a program change offset by a decrease of
$2,124,000 as an administrative adjustment.
Size fees for applications that include lengthy sequence listings have increased from
$250 ($125 for small entities) to $270 ($135 for small entities) for each 50 pages
past 100, but decreases in the estimated number of paper filings result in an overall
decrease of $280,575 from the currently approved collection, with an increase of
$10,050 as a program change offset by a decrease of $290,625 as an
administrative adjustment.

!

This collection is currently approved with $31,024 in capital start-up costs for the
supplies for producing and submitting sequence listings on CD, such as blank
recordable media and shipping envelopes. For this renewal, the USPTO is revising
the estimated capital start-up costs to $11,225 due to the elimination of CD
sequence listing filings for paper PCT applications and expected overall decreases
in paper and CD sequence listing filings (which also reduces the number of CRF
copies submitted on CD). Therefore, this collection takes a burden decrease of
16

$19,799 in capital start-up costs, with a decrease of $1,000 as a program
change and a decrease of $18,799 as an administrative adjustment.
!

This collection is currently approved with a total of $17,280 in recordkeeping costs
associated with keeping back-up copies of CD submissions. For this renewal, the
USPTO estimates that these recordkeeping costs will decrease to $10,400 per year
due to the elimination of CD sequence listing filings for paper PCT applications and
expected overall decreases in CD filings. The estimated hourly rate for
paraprofessionals making back-up CD copies has also increased from $90 to $100.
Therefore, this collection takes a burden decrease of $6,880 in recordkeeping
costs, with a decrease of $2,160 as a program change and a decrease of
$4,720 as an administrative adjustment.

!

This collection is currently approved with a total of $180 in recordkeeping costs
associated with retaining acknowledgment receipts for electronic submissions of
sequence listings. For this renewal, the USPTO estimates that these recordkeeping
costs will increase to $1,300 per year due to expected overall increases in electronic
filing and the increase in estimated hourly rate from $90 to $100 for
paraprofessionals retaining the receipts. Therefore, this collection takes a
burden increase of $1,120 in recordkeeping costs as an administrative
adjustment.

!

This collection is currently approved with a total of $53,104 in postage costs
associated with submitting paper and CD sequence listings to the USPTO by mail.
For this renewal, the USPTO estimates that the total postage costs will decrease to
$21,359 per year due to the elimination of CD sequence listing filings for paper PCT
applications and expected overall decreases in paper and CD filings, despite an
increase in the estimated postage cost from $4.05 to $4.95 per submission.
Therefore, this collection has a burden decrease of $31,745 in postage costs
with a decrease of $810 as a program change and a decrease of $30,935 as an
administrative adjustment.

In sum, this collection has an annual (non-hour) cost burden of $920,959, with $876,675 in
the form of fees, $11,225 in capital start-up costs, $11,700 in recordkeeping costs, and
$21,359 in postage costs. Therefore, this collection has a net decrease in annual (nonhour) cost burden of $3,364,879, with a decrease of $896,920 due to program
changes and a decrease of $2,467,959 due to administrative adjustments.
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

17.

Display of Expiration Date of OMB Approval

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

18

REFERENCES

A.
B.
C.
D.

World Intellectual Property Organization (WIPO) Standard ST.25 (1998)
Patent Cooperation Treaty (PCT) Rule 13ter
The USPTO Information Quality Guidelines
Request for Transfer of a Computer Readable Form under 37 CFR 1.821(e) (PTO/SB/93)

19