[Federal Register Volume 77, Number 209 (Monday, October 29, 2012)]
[Notices]
[Pages 65537-65539]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-26471]
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DEPARTMENT OF COMMERCE
Patent and Trademark Office
Requirements for Patent Applications Containing Nucleotide
Sequence and/or Amino Acid Sequence Disclosures
ACTION: Proposed collection; comment request.
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SUMMARY: The United States Patent and Trademark Office (USPTO), as part
of its continuing effort to reduce paperwork and respondent burden,
invites the general public and other Federal agencies to take this
opportunity to comment on the continuing information collection, as
required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44
U.S.C. 3506(c)(2)(A)).
DATES: Written comments must be submitted on or before December 28,
2012.
ADDRESSES: You may submit comments by any of the following methods:
Email: [email protected]. Include ``0651-
0024 comment'' in the subject line of the message.
Mail: Susan K. Fawcett, Records Officer, Office of the
Chief Information Officer, United States Patent and Trademark Office,
P.O. Box 1450, Alexandria, VA 22313-1450.
Federal Rulemaking Portal: http://www.regulations.gov.
[[Page 65538]]
FOR FURTHER INFORMATION CONTACT: Requests for additional information
should be directed to Raul Tamayo, Legal Advisor, Office of Patent
Legal Administration, United States Patent and Trademark Office, P.O.
Box 1450, Alexandria, VA 22313-1450; by telephone at 571-272-7728; or
by email to [email protected]. Additional information about this
collection is also available at http://www.reginfo.gov under
``Information Collection Review.''
SUPPLEMENTARY INFORMATION:
I. Abstract
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.
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 (http://seqdata.uspto.gov) as an ASCII
text file.
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). 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.
II. Method of Collection
By mail, hand delivery, or electronically to the USPTO.
III. Data
OMB Number: 0651-0024.
Form Number(s): PTO/SB/93.
Type of Review: Revision of a currently approved collection.
Affected Public: Individuals or households; businesses or other
for-profits; and not-for-profit institutions.
Estimated Number of Respondents: 25,250 responses per year. The
USPTO estimates that approximately 27% of these responses will be from
small entities.
Estimated Time per Response: The USPTO estimates that it will take
the public approximately six minutes (0.10 hours) to six hours (6.0
hours) to gather the necessary information, prepare the form or
sequence listing, and submit it to the USPTO.
Estimated Total Annual Respondent Burden Hours: 138,225 hours.
Estimated Total Annual Respondent Cost Burden: $22,590,450. 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. Therefore, the
USPTO estimates that the respondent cost burden for this collection
will be approximately $22,590,450 per year.
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Estimated Estimated
Item Estimated time for response annual annual burden
responses hours
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Sequence Listing in Application (paper)....... 6 hours......................... 8,500 51,000
Sequence Listing in Application (CD).......... 6 hours......................... 500 3,000
Electronic Sequence Listing in Application 6 hours......................... 14,000 84,000
(EFS-Web).
Request for Transfer of a Computer Readable 6 minutes....................... 2,250 225
Form Under 37 CFR 1.821(e) (PTO/SB/93).
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Totals.................................... ................................ 25,250 138,225
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Estimated Total Annual Non-hour Respondent Cost Burden: $2,542,350.
This collection has annual (non-hour) costs in the form of fees and
postage costs. The USPTO provides free software for creating and
validating the format of sequence listings prior to submission.
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 Sec. Sec. 1.52(e) and
1.821(c) or (e), and (ii) causes the application to
[[Page 65539]]
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, for a total
of $336,000 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 $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 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, for a total of
$2,160,000 per year in page fees. Therefore, this collection has a
total of $2,496,000 in fees per year.
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
information. The USPTO estimates that the average postage cost for a
paper or CD sequence listing submission will be $5.15 and that 9,000
sequence listings will be mailed to the USPTO per year, for a total
postage cost of $46,350 per year.
The total annual (non-hour) respondent cost burden for this
collection in the form of fees and postage costs is estimated to be
$2,542,350 per year.
IV. Request for Comments
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the agency, including whether the information shall have practical
utility; (b) the accuracy of the agency's estimate of the burden
(including hours and cost) of the proposed collection of information;
(c) ways to enhance the quality, utility, and clarity of the
information to be collected; and (d) ways to minimize the burden of the
collection of information on respondents, e.g., the use of automated
collection techniques or other forms of information technology.
Comments submitted in response to this notice will be summarized or
included in the request for OMB approval of this information
collection; they also will become a matter of public record.
Dated: October 24, 2012.
Susan K. Fawcett,
Records Officer, USPTO, Office of the Chief Information Officer.
[FR Doc. 2012-26471 Filed 10-26-12; 8:45 am]
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