Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures, 34601-34603 [E6-9343]

Agencies

• Patent and Trademark Office

[Federal Register Volume 71, Number 115 (Thursday, June 15, 2006)]
[Notices]
[Pages 34601-34603]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E6-9343]


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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 August 14, 2006.

ADDRESSES: You may submit comments by any of the following methods:
    E-mail: Susan.Brown@uspto.gov. Include ``0651-0024 comment'' in the 
subject line of the message.
    Fax: 571-273-0112, marked to the attention of Susan Brown.
    Mail: Susan K. Brown, Records Officer, Office of the Chief 
Information Officer, Architecture, Engineering and Technical Services, 
Data Architecture and Services Division, U.S. Patent and Trademark 
Office, P.O. Box 1450, Alexandria, VA 22313-1450.
    Federal e-Rulemaking Portal: https://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Requests for additional information 
should be directed to Robert J. Spar, Director, Office of Patent Legal 
Administration, U.S. Patent and Trademark Office, P.O. Box 1450, 
Alexandria, VA 22313-1450; by telephone at 571-272-7700; or by e-mail 
at Bob.Spar@uspto.gov.

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

[[Page 34602]]

approximately 300 printed pages) are published only in electronic form 
and are available to the public on the USPTO sequence data Web page.
    The USPTO recognizes that the submission of massive paper versions 
of extremely long sequence listings would place a significant burden on 
applicants and the USPTO, while also being of minimal utility for 
examination purposes. Consequently, applicants may submit the sequence 
listing required by 37 CFR 1.821(c) on paper or compact disc (CD). 
Applicants may also file sequence listings for U.S. applications 
electronically using the Electronic Filing System (EFS) software 
developed by the USPTO for secure transmission of patent applications 
and related documents over the Internet. Applicants may use EFS to file 
a sequence listing electronically 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 electronically using EFS do not 
require a separate CRF copy.
    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. Customers may use a 
checkbox on Form PTO/SB/05 Utility Patent Application Transmittal, 
which is covered under OMB Control Number 0651-0032, to indicate the 
submission of a sequence listing for a U.S. patent application. The 
USPTO also provides a sample format for the transmittal documentation 
that must be submitted with a sequence listing on CD for an 
international patent application. Applicants who submit sequence 
listings using EFS must complete the electronic transmittal forms 
included within the submission software.

II. Method of Collection

    By mail, hand delivery, or electronically to the USPTO.

III. Data

    OMB Number: 0651-0024.
    Form Number(s): None.
    Type of Review: Revision of a currently approved collection.
    Affected Public: Individuals or households; businesses or other 
for-profits; not-for-profit institutions; farms; the Federal 
Government; and state, local or tribal governments.
    Estimated Number of Respondents: 15,382 responses per year.
    Estimated Time per Response: The USPTO estimates that it will take 
the public approximately ten minutes (0.17 hours) to one hour and 20 
minutes (1.33 hours) to gather the necessary information, prepare the 
sequence listing, and submit it to the USPTO, depending on whether the 
listing is submitted on paper, on CD, or electronically.
    Estimated Total Annual Respondent Burden Hours: 17,297 hours per 
year.
    Estimated Total Annual Respondent Cost Burden: $1,556,730 per year. 
The USPTO expects that the information in this collection will be 
prepared by paraprofessionals at an estimated rate of $90 per hour. 
Therefore, the USPTO estimates that the respondent cost burden for this 
collection will be approximately $1,556,730 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).......  1 hour and 20 minutes...........          11,512          15,311
Sequence Listing in Application (CD)..........  1 hour..........................           1,600           1,600
Electronic Sequence Listing in Application      10 minutes......................           2,270             386
 (EFS).
                                                                                 -------------------------------
    Total.....................................  ................................          15,382          17,297
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    Estimated Total Annual Non-hour Respondent Cost Burden: $4,285,658 
per year. There are no maintenance costs associated with this 
collection. The USPTO provides free software for creating and 
validating the format of the sequence listings prior to submission. 
However, this collection does have annual (non-hour) costs in the form 
of filing 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, but there is a filing fee of 
$4,800 for submitting a sequence listing in electronic form (on CD) as 
part of an international PCT application. The USPTO estimates that 
approximately 200 of the 1,600 CD sequence listings submitted per year 
will be for international applications, for a total of $960,000 per 
year. While there is no additional fee for a sequence listing filed on 
paper in an international application, the basic international filing 
fee only covers the first 30 pages of the application. As a result, 
there is a $12 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 $1,800 if the international application were 
already at least 30 pages long without the listing. The USPTO estimates 
that approximately 1,560 of the 11,512 paper sequence listings 
submitted per year will be for international applications, for a total 
of $2,808,000 per year. Therefore, this collection has $3,768,000 per 
year in filing fees that may be associated with paper and CD sequence 
listings for international applications.
    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 
$250 (or $125 for small entities) for each additional 50 pages or 
fraction thereof. The USPTO estimates that approximately 400 
applications with long paper sequence listings will incur an average 
application size fee of $750, and approximately 310 applications with 
long paper listings from small entities will incur an average 
application size fee of $375, for a total of $416,250 per year. 
Therefore, this

[[Page 34603]]

collection has a total of $4,184,250 in filing 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 1,600 CD submissions per year, for a total of 
$4,800. 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 
13,112 CRF copies for paper and CD sequence listings at an estimated 
cost of $2 per copy, for a total of $26,224. Therefore, this collection 
has total capital start-up costs of $31,024 per year associated with 
submitting sequence listings and CRF copies on CD.
    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 1,600 CD submissions will be received per year, for a 
total of 192 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 $90 per hour, for a total recordkeeping cost of 
$17,280 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 $4.05 and that 13,112 
sequence listings will be mailed to the USPTO per year, for a total 
postage cost of $53,104 per year.
    The total non-hour respondent cost burden for this collection in 
the form of filing fees, capital start-up costs, recordkeeping costs, 
and postage costs is estimated to be $4,285,658 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: June 9, 2006.
Susan K. Brown,
Records Officer, USPTO, Office of the Chief Information Officer, 
Architecture, Engineering and Technical Services, Data Architecture and 
Services Division.
 [FR Doc. E6-9343 Filed 6-14-06; 8:45 am]
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