[Federal Register Volume 74, Number 153 (Tuesday, August 11, 2009)]
[Notices]
[Pages 40163-40165]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-19179]
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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 revision of a 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 October 13,
2009.
ADDRESSES: You may submit comments by any of the following methods:
E-mail: [email protected]. Include A0651-0024
comment@ in the subject line of the message.
Fax: 571-273-0112, marked to the attention of Susan K.
Fawcett.
Mail: Susan K. Fawcett, Records Officer, Office of the
Chief Information Officer, Administrative Management Group, United
States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA
22313-1450.
Federal Rulemaking Portal: http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Requests for additional information
should be directed to Robert A. Clarke, Director, Office of Patent
Legal Administration, United States Patent and Trademark Office, P.O.
Box 1450, Alexandria, VA 22313-1450; by telephone at 571-272-7735; or
by e-mail to [email protected].
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.
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 a 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 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 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: 19,750 responses per year.
Estimated Time Per Response: The USPTO estimates that it will take
the public approximately six minutes (0.10 hours) to one hour and 20
minutes (1.33 hours) to gather the necessary information, prepare the
form or sequence listing, and submit it to the USPTO.
Estimated Total Annual Respondent Burden Hours: 7,254 hours per
year.
Estimated Total Annual Respondent Cost Burden: $725,400 per year.
The USPTO expects that the information in this collection will be
prepared by paraprofessionals at an estimated rate of $100 per hour.
Therefore, the USPTO estimates that the respondent cost burden for this
collection will be approximately $725,400 per year.
[[Page 40164]]
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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)....... 1 hour and 20 minutes........... 3,450 4,589
Sequence Listing in Application (CD).......... 15 minutes...................... 865 216
Electronic Sequence Listing in Application 10 minutes...................... 12,935 2,199
(EFS-Web).
Request for Transfer of a Computer Readable 6 minutes....................... 2,500 250
Form under 37 CFR 1.821(e) (PTO/SB/93).
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Totals.................................... ................................ 19,750 7,254
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Estimated Total Annual Non-hour Respondent Cost Burden: $920,959
per year. 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 start-up costs, recordkeeping costs, and postage
costs.
There is no separate filing fee for submitting a sequence listing
as part of a U.S. patent application. While there is also no filing fee
for a sequence listing filed in an international application, the basic
international filing fee only covers the first 30 pages of the
application. As a result, there is a $13 fee per page that is added to
the international filing fee for each page over 30 pages. The average
length of a paper sequence listing 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
paper sequence listings submitted per year will be for international
applications, for a total of $741,000 per year in page fees. There are
no page fees for sequence listings that are submitted via EFS-Web in
the proper text format.
Under 37 CFR 1.16(s) and 1.492(j), both U.S. and international
patent applications that include lengthy paper sequence listings may be
subject to an application size fee. For applications with paper
sequences listings that exceed 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 with long paper sequence listings from large entities will
incur an average application size fee of $810, and approximately 95
applications with long paper sequence listings from small entities will
incur an average application size fee of $405, for a total of $135,675
per year. 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 CD 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
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, for a total
postage cost of $21,359 per year.
The total non-hour respondent cost burden for this collection in
the form of fees, capital start-up costs, recordkeeping costs, and
postage costs is estimated to be $920,959 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
[[Page 40165]]
approval of this information collection; they also will become a matter
of public record.
Dated: August 4, 2009.
Susan K. Fawcett,
Records Officer, USPTO, Office of the Chief Information Officer,
Administrative Management Group.
[FR Doc. E9-19179 Filed 8-10-09; 8:45 am]
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