[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]


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

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.

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

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.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           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)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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).
                                                                       ---------------------------------------------------------------------------------
    Totals..........................  ................................  ..............          28,850          163,955  ..............    31,771,829.00
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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
----------------------------------------------------------------------------------------------------------------
                                                                  Estimated
               IC No.                           Item               annual        Fee amount        Total fees
                                                                  responses
                                                                          (a)             (b)    (a) x (b) = (c)
----------------------------------------------------------------------------------------------------------------
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).
                                                              --------------------------------------------------
    Totals..........................  .......................          28,536  ..............       1,538,425.00
----------------------------------------------------------------------------------------------------------------

    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]
 BILLING CODE 3510-16-P