Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures, 14425-14427 [2016-06011]

Agencies

• DEPARTMENT OF COMMERCE
• United States Patent and Trademark Office

[Federal Register Volume 81, Number 52 (Thursday, March 17, 2016)]
[Notices]
[Pages 14425-14427]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-06011]


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DEPARTMENT OF COMMERCE

United States Patent and Trademark Office


Requirements for Patent Applications Containing Nucleotide 
Sequence and/or Amino Acid Sequence Disclosures

ACTION: Notice and request for comment.

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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 comment on 
proposed and/or continuing information collections, 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 May 16, 2016.

ADDRESSES: Written comments may be submitted by any of the following 
methods:
     Email: InformationCollection@uspto.gov. Include ``0651-
0024 inquiry'' in the subject line of the message.
     Federal Rulemaking Portal: https://www.regulations.gov.
     Mail: Marcie Lovett, Records Management Division Director, 
Office of the Chief Information Officer, United States Patent and 
Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450.

FOR FURTHER INFORMATION CONTACT: Requests for additional information 
should be directed to Raul Tamayo, Senior Legal Advisor, Office of 
Patent Legal Administration, United States

[[Page 14426]]

Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450; 
by telephone at 571-272-7728; or by email at Raul.Tamayo@uspto.gov with 
``0651-0024 inquiry'' in the subject line. Additional information about 
this collection is also available at https://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. Applicants may 
submit sequence listings for both U.S. and international patent 
applications. Submissions of sequence listings in international 
applications are in accordance with Patent Cooperation Treaty (PCT) 
Rule 13\ter\.
    This information collection contains the sequence listing 
information itself. Information pertaining to the filing of the initial 
U.S. application is collected under OMB Control Number 0651-0032, and 
information pertaining to the filing of the initial international 
application is collected under OMB Control Number 0651-0021.
    In particular, this information collection accounts for sequence 
listings submitted on paper, compact disc (CD), or through EFS-Web, the 
USPTO's online filing system. For U.S. applications, 37 CFR 1.821(c) 
permits all three modes of submission: Paper, CD, or EFS-Web. 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 though EFS-Web may be submitted on a separate CD.
    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.
    This information collection also contains requests for transfer of 
a computer readable form under 37 CFR 1.821(e). Under 37 CFR 1.821(e)-
(f), applicants who submit their sequence listings on paper or CD must 
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.

II. Method of Collection

    By mail, hand delivery, or electronic submission to the USPTO.

III. Data

    OMB Number: 0651-0024.
    Type of Review: Revision of a currently-approved collection.
    Affected Public: Individuals or households; business or other for-
profit organizations; and not-for-profit organizations.
    Estimated Number of Respondents: 27,200 responses per year. Of this 
total, the USPTO expects that 25% will be from small entities.
    Estimated Time per Response: The USPTO estimates that it will take 
approximately 6 minutes (0.10 hours) to 6 hours to complete a single IC 
item in this collection, depending on the instrument. This includes the 
time to gather the necessary information, create the documents, and 
submit the completed request to the USPTO.
    Estimated Total Annual Hour Burden: 152,285 hours.
    Estimated Total Annual Cost Burden (Hourly): $26,260,375.00. The 
USPTO estimates that a sequence listing will take approximately five 
hours of paraprofessional time at an estimated rate of $125 per hour 
and one hour of attorney time at $410 per hour, for a weighted average 
rate of $172.50 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 $125 per hour. Using this 
hourly rate, the USPTO estimates $26,260,375.00 per year for the total 
hourly costs associated with respondents.

                                                     Table 1--Burden Hour/Burden Cost to Respondents
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                                                                           Estimated       Estimated       Estimated
                IC No.                               Item                response time      annual       annual burden    Rate ($/hr)    Total cost ($/
                                                                            (hours)        responses         hours                             yr)
                                                                                   (a)             (b)     (a) x (b) =             (d)   (c) x (d) = (e)
                                                                                                                   (c)
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1....................................  Sequence Listing in Application            6.00           6,000          36,000         $172.50     $6,210,000.00
                                        (paper).
1....................................  Sequence Listing in Application            6.00             350           2,100          172.50        362,250.00
                                        (CD).
1....................................  Sequence Listing in Application            6.00          19,000         114,000          172.50     19,665,000.00
                                        (electronic).
2....................................  Request for Transfer of a                  0.10           1,850             185          125.00         23,125.00
                                        Computer Readable Form Under
                                        37 CFR 1.821(e) (PTO/SB/93).
                                                                       ---------------------------------------------------------------------------------
    Totals...........................  ...............................  ..............          27,200         152,285  ..............     26,260,375.00
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    Estimated Total Annual Cost Burden (Non-Hourly): $1,774,500.00. 
This collection has no capital startup, maintenance, or operating fees. 
This collection does have a non-hourly cost

[[Page 14427]]

burden in the form of filing fees and postage costs.

Filing Fees

    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 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 $400 (or $200 for small 
entities and $100 for micro entities) for each additional 50 pages or 
fraction thereof. The USPTO estimates the following with respect to the 
number of applications that will include long sequence listings filed 
on paper or on a non-compliant electronic medium and the average 
application size fee that such applications will incur: (i) 
Approximately 200 applications from large entities will incur an 
average application size fee of $1,200; (ii) approximately 100 
applications from small entities will incur an average application size 
fee of $600; and (iii) approximately 40 applications from micro 
entities will incur an average application size fee of $300. The 
estimate corresponds to a total fee cost of $240,000, $60,000, and 
$12,000, respectively.
    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 $15 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 $2,250 if the international application were already at least 30 
pages long without the listing. The USPTO estimates that approximately 
650 of the 6,000 sequence listings filed per year on paper or in PDF 
format will be for international applications, for a cost of 
$1,462,500.
    Therefore, the USPTO estimates that the total fee costs for this 
collection will total $1,774,500.00.

Postage Costs

    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 $6.45 (USPS Priority Mail, flat rate envelope) and 
that 6,350 sequence listings will be mailed to the USPTO per year, for 
a total of $40,957.50 in postage costs.
    With filing fee costs totaling $1,774,500.00 and postage costs 
totaling $40,957.50, the USPTO estimates that the total annual non-
hourly cost burden for this collection will amount to $1,815,457.50.

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, including 
the validity of the methodology and assumptions used;
    (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, including through the use of automated collection 
techniques or other forms of information technology, e.g., permitting 
electronic submission of responses.
    Comments submitted in response to this notice will be summarized or 
included in the request for OMB approval of this information 
collection; they will also become a matter of public record.

    Dated: March 11, 2016.
Marcie Lovett,
Records Management Division Director, OCIO, United States Patent and 
Trademark Office.
[FR Doc. 2016-06011 Filed 3-16-16; 8:45 am]
BILLING CODE 3510-16-P