[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: [email protected]. Include ``0651-
0024 inquiry'' in the subject line of the message.
Federal Rulemaking Portal: http://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 [email protected] with
``0651-0024 inquiry'' in the subject line. 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. 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).
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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
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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]
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