[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]
BILLING CODE 3510-16-P