[Federal Register Volume 68, Number 84 (Thursday, May 1, 2003)]
[Notices]
[Pages 23288-23290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-10704]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 June 30, 2003.

ADDRESSES: Direct all written comments to Susan K. Brown, Records 
Officer, Office of Data Architecture and Services, Data Administration 
Division, U.S. Patent and Trademark Office, Suite 310, 2231 Crystal 
Drive, Arlington, VA 22202; by telephone at (703) 308-7400; or by 
electronic mail at [email protected].

FOR FURTHER INFORMATION CONTACT: Requests for additional information 
should be directed to Robert J. Spar, Director, Office of Patent Legal 
Administration, USPTO, P.O. Box 1450, Alexandria, VA 22313-1450; by 
telephone at (703) 308-5107; or by electronic mail at 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Abstract

    The requirements for submitting nucleotide and/or amino acid 
sequence disclosures as part of a patent application are outlined in 37 
CFR 1.821-1.825. The rules of practice require patent applicants to 
submit these sequence listings in a standard international format that 
is consistent with World Intellectual Property Organization (WIPO) 
Standard ST.25 (1998). Sequence listings may be submitted for both 
national and international patent applications.

[[Page 23289]]

    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 
(more than 600K or approximately 300 typed pages) are published only in 
electronic form and are available to the public on the USPTO sequence 
data web page.
    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. Previously, the 
rules of practice required applicants to submit a paper copy of the 
sequence listing as the official archival copy. Due to the recognition 
that the submission of massive paper versions of extremely long 
sequence listings was a significant burden on applicants and the USPTO 
and of minimal utility for examination purposes, the USPTO amended the 
rules of practice in a Final Rule Notice published in the Federal 
Register on September 8, 2000, entitled ``Changes to Implement the 
Patent Business Goals'' (Vol. 65, No. 175), to allow the official copy 
of the sequence listing under 37 CFR 1.821(c) to be submitted either in 
paper or on compact disc (CD).
    Under 37 CFR 1.821(e), 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 official 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, a new CRF copy of the amended listing must also be submitted.
    Applicants may submit the CRF copy of the sequence listing to the 
USPTO on CD, as provided in 37 CFR 1.824. Sequence listings may also be 
filed 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.
    There are no paper forms associated with the collection of sequence 
information filed with a patent application. Applicants who submit 
sequence listings electronically using EFS must complete the electronic 
transmittal forms provided within the electronic submission software 
provided by the USPTO. If a sequence listing is filed via EFS 
subsequent to a previously filed application, the CRF copy may be 
submitted electronically but the applicant must also mail a paper or CD 
copy of the sequence listing to the USPTO along with a statement 
indicating that the paper or CD copy and the CRF copy are identical.
    In November 2001, OMB approved a change worksheet that increased 
the burden for this information collection due to increases in patent 
application filings involving nucleotide and amino acid sequence 
listings. However, although the total number of annual responses for 
this collection increased, the proportion of these responses that were 
submitted electronically was lower than originally estimated.

II. Method of Collection

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

III. Data

    OMB Number: 0651-0024.
    Form Number(s): None.
    Type of Review: Extension 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: 23,750 responses per year.
    Estimated Time Per Response: The USPTO estimates that it will take 
the public approximately 1 hour and 20 minutes (1.33 hours) to gather 
the necessary information, prepare the paper sequence listing, and 
submit it to the USPTO. For sequence listings prepared on CD, the USPTO 
estimates that it will take the public approximately 1 hour to prepare 
and submit the sequence listing. For submissions filed electronically 
using EFS, the USPTO estimates that it will take the public 
approximately 10 minutes (0.17 hours) to prepare and submit the 
sequence listing.
    Estimated Total Annual Respondent Burden Hours: 29,856 hours per 
year.
    Estimated Total Annual Respondent Cost Burden: $895,680 per year. 
The USPTO expects that the information in this collection will be 
prepared by paraprofessionals at an estimated rate of $30 per hour. 
Therefore, the USPTO estimates that the respondent cost burden for this 
collection will be $895,680 per year.

----------------------------------------------------------------------------------------------------------------
                                                                                     Estimated       Estimated
                     Item                          Estimated time for response        annual       annual burden
                                                                                     responses         hours
----------------------------------------------------------------------------------------------------------------
Sequence Listing in Application (paper).......  1.33 hours......................          18,880          25,110
Sequence Listing in Application (CD)..........  1 hour..........................           4,720           4,720
Electronic Sequence Listing in Application      10 minutes......................             150              26
 (EFS).
                                                                                 -----------------
    Total.....................................  ................................          23,750          29,856
----------------------------------------------------------------------------------------------------------------

    Estimated Total Annual Non-hour Respondent Cost Burden: $50,598 per 
year. There are no maintenance costs or filing fees associated with 
this collection. There is no separate filing fee for submitting a 
sequence listing as part of a patent application. The USPTO also 
provides PatentIn authoring software for creating the sequence listing 
in the proper format, which may be downloaded at no cost from the USPTO 
Web site. However, this collection does have annualized costs in the 
form of capital start-up costs, recordkeeping costs, and postage costs.
    There are capital start-up costs associated with submitting 
sequence listings to the USPTO on CD. Producing a CD requires 
additional hardware, software, and supplies, including a CD drive 
capable of recording onto CD media (a ``CD burner''), CD recording 
software, blank recordable CD (CD-R) media, cases and labels for the 
CDs, and a padded mailing envelope for shipping. The cost of a CD 
burner is approximately $200, depending on the speed and type of PC 
connection. Commercial software for recording CDs retails for 
approximately $100, although basic CD recording software is typically 
included with the CD burner. The cost of blank CD-R media with plastic 
cases is approximately $10 for 10 blank CDs, and the cost of software 
and supplies for labeling CDs is approximately $20. Padded mailing 
envelopes for safely

[[Page 23290]]

shipping the CDs cost approximately $12 for a package of 12. The total 
capital start-up cost for this collection is $342 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 5 minutes to produce a 
back-up CD copy and 2 minutes to print copies of documentation, for a 
total of 7 minutes (0.12 hours) to make a back-up copy of the CD 
submission. The USPTO estimates that approximately 4,720 CD submissions 
will be received per year, for a total of 566 hours (4,720 responses 
multiplied by 0.12 hours). The USPTO expects that these back-up copies 
will be prepared by paraprofessionals at an estimated rate of $30 per 
hour, for a total recordkeeping cost of $16,980 per year.
    Customers may incur postage costs when submitting a sequence 
listing to the USPTO by mail. The USPTO estimates that the average 
first-class postage cost for a mailed sequence listing submission on 
paper or CD will be $1.41 and that 23,600 sequence listings will be 
mailed to the USPTO per year. The total postage cost for this 
collection is $33,276 per year.
    The total non-hour respondent cost burden for this collection in 
the form of capital start-up costs and postage costs is $50,598 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: April 23, 2003.
Susan K. Brown,
Records Officer, USPTO, Office of Data Architecture and Services, Data 
Administration Division.
[FR Doc. 03-10704 Filed 4-30-03; 8:45 am]
BILLING CODE 3510-16-P