Requirements for Patent Applications Containing Nucleotide Sequence and/or Amino Acid Sequence Disclosures
| Citation | 84 FR 16652 |
| Record Number | 2019-08027 |
| Published date | 22 April 2019 |
| Section | Notices |
| Court | United States Patent And Trademark Office |
Federal Register, Volume 84 Issue 77 (Monday, April 22, 2019)
[Federal Register Volume 84, Number 77 (Monday, April 22, 2019)]
[Notices]
[Pages 16652-16654]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08027]
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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: Proposed collection; comment request.
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SUMMARY: The United States Patent and Trademark Office (USPTO), as
required by the Paperwork Reduction Act of 1995, invites comments on
this proposed extension of an existing information collection.
DATES: Written comments must be submitted on or before June 21, 2019.
ADDRESSES: Written comments may be submitted by any of the following
methods:
Email: [email protected]. Include ``0651-
0024 comment'' in the subject line of the message.
Federal Rulemaking Portal: http://www.regulations.gov.
Mail: Marcie Lovett, Chief, Records and Information
Governance Branch, Office of the Chief Administrative 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 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 comment'' 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 that fall within the definitions of 37 CFR
1.821(a) must include, as a separate part of the application
disclosure, 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) Rules 5.2 and 13ter, as
well as the PCT Administrative Instructions, Annex C.
This information collection covers the submission of 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. Sequence listings may be submitted via
EFS-Web as an ASCII text file or in Portable Document Format (PDF). For
U.S. applications, Sec. 1.821(c) permits all 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 CD.
This information collection also accounts for the requirement under
Sec. 1.821(e) that a copy of the sequence listing required by Sec.
1.821(c) be submitted in computer readable form (CRF) in accordance
with the requirements of Sec. 1.824. Under Sec. Sec. 1.821(e)-(f),
applicants who submit their sequence listings on paper, CD, or as a PDF
via EFS-Web must submit a copy of the sequence listing in CRF with a
statement indicating that the CRF copy of the sequence listing is
identical to the paper, CD, or PDF copy provided under Sec. 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 Sec. 1.824. If a new
[[Page 16653]]
application is filed via EFS-Web with an ASCII text file sequence
listing that complies with the requirements of Sec. Sec. 1.824(a)(2)-
(6) and (b), and applicant has not filed a sequence listing on paper,
CD or as a PDF file, the text file will serve as both the copy required
by Sec. 1.821(c) and the CRF required by Sec. 1.821(e). Moreover, the
associated statement of identity would not be required.
This information collection also covers the mechanism in Sec.
1.821(e) where an applicant may request, in limited circumstances, a
transfer of the CRF from the application already on file to the new
application, 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. 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.
The USPTO uses the sequence listings during the examination process
to determine the patentability of the associated patent application.
The information in CRF is entered into the USPTO's database for
searching and printing nucleotide and amino acid sequences. Sequence
listings also are disclosed as part of the published patent application
or issued patent and are provided to the National Center for
Biotechnology Information (NCBI) for inclusion in their sequence
database.
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: 28,850 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 Respondent Burden Hours: 163,955 hours.
Estimated Total Annual Respondent (Hourly) Cost Burden:
$31,771,829.00. The USPTO estimates that a sequence listing will take
approximately five hours of paraprofessional time at an estimated rate
of $145 per hour and one hour of attorney time at $438 per hour, for a
weighted average rate of $193.83 per hour for preparing a sequence
listing. These rates are found in the 2017 Report of the Economic
Survey of the America Intellectual Property Law Association (AIPLA).
The USPTO expects that the Request for Transfer of a CRF will be
prepared by a paraprofessional at an estimated rate of $145 per hour.
Using this hourly rate, the USPTO estimates $31,771,829.00 per year for
the total hourly costs associated with respondents.
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Estimated Estimated Estimated
IC No. Item response time annual annual burden Rate ($/hr) Total Cost ($/
(hours) responses hours yr)
(a) (b) (a) x (b) = (c) (d) (c) x (d) = (e)
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1................................... Sequence Listing in Application 6.00 5,000 30,000 $193.83 $5,814,900.00
(paper).
1................................... Sequence Listing in Application 6.00 300 1,800 193.83 348,894.00
(CD).
1................................... Sequence Listing in Application 6.00 22,000 132,000 193.83 25,585,560.00
(electronic).
2................................... Request for Transfer of a 0.10 1,550 155 145.00 22,475.00
Computer Readable Form Under 37
CFR 1.821(e) (PTO/SB/93).
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Totals.......................... ................................ .............. 28,850 163,955 .............. 31,771,829.00
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Estimated Total Annual (Non-hour) Respondent Cost Burden:
$1,774,500.00. This collection has no capital startup, maintenance, or
operating fees. This collection does have a non-hourly cost 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 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 160
applications from large entities will incur an average application size
fee of $1,200; (ii) approximately 80 applications from small entities
will incur an average application size fee of $600; and (iii)
approximately 32 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
[[Page 16654]]
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 520 of the 6,000 sequence listings filed per year on
paper or in PDF format will be for international applications.
The USPTO charges a fee for the handling of mega sequence listings,
i.e., sequence listings of 300 MB or more. Pricing for this fee is
divided into two tiers with Tier 1 for file sizes 300 MB to 800 MB and
Tier 2 for file sizes greater than 800 MB. The USPTO also charges a
fee, i.e., the Late Furnishing Fee for Providing a Sequence Listing in
Response to an Invitation Under PCT Rule 13ter, to encourage timely
filing of sequence listings in international applications and to
facilitate the effective administration of the patent system.
Table 2--Filing Fee Costs
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Estimated
IC No. Item annual Fee amount Total fees
responses
(a) (b) (a) x (b) = (c)
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1................................... Size fees under 37 CFR 160 $1,200.00 $192,000.00
1.16(s) and 1.492(j),
large entity.
1................................... Size fees under 37 CFR 80 600.00 48,000.00
1.16(s) and 1.492(j),
small entity.
1................................... Size fees under 37 CFR 32 300.00 9,600.00
1.16(s) and 1.492(j),
micro entity.
1................................... Size fees for 520 2,250.00 1,170,000.00
international
applications.
1................................... Submission of sequence 20 1,000.00 20,000.00
listings of 300MB to
800MB (large entity).
1................................... Submission of sequence 13 500.00 6,500.00
listings of 300MB to
800MB (small entity).
1................................... Submission of sequence 2 250.00 500.00
listings of 300MB to
800MB (micro entity).
1................................... Submission of sequence 1 10,000.00 10,000.00
listings of more than
800MB (large entity).
1................................... Submission of sequence 1 5,000.00 5,000.00
listings of more than
800MB (small entity).
1................................... Submission of sequence 1 2,500.00 2,500.00
listings of more than
800MB (micro entity).
1................................... Late Furnishing Fee for 91 300.00 27,300.00
Providing a Sequence
Listing in Response to
an Invitation Under
PCT Rule 13ter (large
entity).
1................................... Late Furnishing Fee for 312 150.00 46,800.00
Providing a Sequence
Listing in Response to
an Invitation Under
PCT Rule 13ter (small
entity).
1................................... Late Furnishing Fee for 3 75.00 225.00
Providing a Sequence
Listing in Response to
an Invitation Under
PCT Rule 13ter (micro
entity).
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Totals.......................... ....................... 28,536 .............. 1,538,425.00
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Therefore, the USPTO estimates that the total fee costs for this
collection will total $1,538,425.00.
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 $6.55 (USPS Priority Mail, flat rate envelope) and
that 5,300 sequence listings will be mailed to the USPTO per year, for
a total of $34,715.00 in postage costs.
With filing fee costs totaling $1,538,425.00 and postage costs
totaling $34,715.00, the USPTO estimates that the total annual non-
hourly cost burden for this collection will amount to $1,573,140.00.
IV. Request for Comments
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.
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.
Marcie Lovett,
Chief, Records and Information Governance Branch, Office of the Chief
Administrative Officer, United States Patent and Trademark Office.
[FR Doc. 2019-08027 Filed 4-19-19; 8:45 am]
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