[Federal Register: August 11, 2009 (Volume 74, Number 153)]
[Notices]               
[Page 40163-40165]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11au09-46]                         

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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: Susan.Fawcett@uspto.gov. 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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 Robert.Clarke@uspto.gov.

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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