[Federal Register Volume 87, Number 109 (Tuesday, June 7, 2022)]
[Notices]
[Pages 34667-34669]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12138]


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DEPARTMENT OF COMMERCE

 Patent and Trademark Office


Agency Information Collection Activities; Submission to the 
Office of Management and Budget (OMB) for Review and Approval; Comment 
Request; Requirements for Patent Applications Containing Nucleotide 
Sequence and/or Amino Acid Sequence Disclosures

AGENCY: United States Patent and Trademark Office, Department of 
Commerce.

ACTION: Notice of information collection; request for comment.

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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 
the extension and revision of an existing information collection: 0651-
0024 (Requirements for Patent Applications Containing Nucleotide 
Sequence and/or Amino Acid Sequence Disclosures). The purpose of this 
notice is to allow 60 days for public comment preceding submission of 
the information collection to OMB.

DATES: To ensure consideration, comments regarding this information 
collection must be received on or before August 8, 2022.

ADDRESSES: Interested persons are invited to submit written comments by 
any of the following methods. Do not submit Confidential Business 
Information or otherwise sensitive or protected information.
     Email: [email protected]. Include ``0651-
0024 comment'' in the subject line of the message.
     Federal Rulemaking Portal: http://www.regulations.gov.
     Mail: Kimberly Hardy, 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 Parikha Mehta, Legal Advisor, United States 
Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313-1450; 
by telephone at 571-272-3248; or by email at [email protected] 
with ``0651-0024 comment'' in the subject line. Additional information 
about this information 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 meeting the definitions of 37 CFR 1.821(a) must 
include, as a separate part of the 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 
biotechnology patent applications. Submissions of sequence listings in 
international applications are governed by Patent Cooperation Treaty 
(PCT) Rules 5.2 and 13ter, as well as the PCT Administrative 
Instructions, Annex C.
    The USPTO uses applicants' sequence listings during the examination 
process to determine the patentability of the claimed invention. The 
USPTO also uses sequence listings for publication of patent 
applications and issued patents. Sequence listings are publicly 
searchable after publication and/or issuance.
    This information collection covers the submission of sequence 
listing information itself. Information pertaining to the initial 
filing of U.S. patent applications is collected under

[[Page 34668]]

OMB Control Number 0651-0032, and information pertaining to the initial 
filing of international applications is collected under OMB Control 
Number 0651-0021.
    Sequence listings may be submitted via the Patent Electronic System 
as an ASCII text file or as a Portable Document Format (PDF) file. For 
U.S. applications, 37 CFR 1.821(c) permits all modes of submission: 
paper, read-only optical disc, or electronic filing via the Patent 
Electronic System. Sequence listings for international applications may 
only be submitted on paper or through the Patent Electronic System. 
Sequence listings that are too large to be filed electronically through 
the Patent Electronic System may be submitted on read-only optical 
disc.
    This information collection also accounts for the requirement under 
37 CFR 1.821(e) that a copy of the sequence listing required by 37 CFR 
1.821(c) be submitted in computer readable form (CRF) in accordance 
with 37 CFR 1.824. Under 37 CFR 1.821(e)-(f), applicants who submit 
their sequence listings on paper, read-only optical disc, or as a PDF 
via the Patent Electronic System 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, read-only optical disc, or 
PDF copy provided under 37 CFR 1.821(c). Applicants may submit the CRF 
copy of the sequence listing to the USPTO on read-only optical disc or 
other acceptable media as provided in 37 CFR 1.824. If a new 
application is filed via the Patent Electronic System with an ASCII 
text file sequence listing that complies with the requirements of 37 
CFR 1.824(a)(2)-(6) and (b), and applicant has not filed a sequence 
listing on paper, read-only optical disc, or as a PDF file, the text 
file will serve as both the copy required by 37 CFR 1.821(c) and the 
CRF required by 37 CFR 1.821(e). Moreover, the associated statement 
regarding both copies being identical would not be required.
    One item, Request for Transfer of a Computer Readable Form under 37 
CFR 1.821(e), has been removed from this information collection. This 
item is no longer part of this information collection's process per a 
recent rulemaking (Electronic Submission of a Sequence Listing, a Large 
Table, or a Computer Program Listing Appendix in Patent Applications; 
86 FR 57035, 10/14/2021).

II. Method of Collection

    The items in this information collection may be submitted to the 
USPTO by mail, hand delivery, or electronic submission via the Patent 
Electronic System.

III. Data

    OMB Control Number: 0651-0024.
    Forms: None.
    Type of Review: Extension and revision of a currently approved 
information collection.
    Affected Public: Private sector; individuals or households.
    Respondent's Obligation: Required to obtain or retain benefits.
    Estimated Number of Annual Respondents: 9,550 respondents.
    Estimated Number of Annual Responses: 28,550 responses.
    Estimated Time per Response: The USPTO estimates that the responses 
in this information collection will take the public approximately 6 
hours to complete. This includes the time to gather the necessary 
information, create the item, and submit the completed item to the 
USPTO.
    Estimated Total Annual Respondent Burden Hours: 171,300 hours.
    Estimated Total Annual Respondent Hourly Cost Burden: $74,515,500.

                                       Table 1--Total Burden Hours and Hourly Costs to Private Sector Respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Estimated
                                    Estimated     Responses per  Estimated  annual     time per      Estimated burden   Rate \1\  ($/   Estimated annual
  Item No.          Item             annual        respondent        responses         response        (hour/year)          hour)       respondent cost
                                   respondents                                          (hours)                                              burden
                                            (a)             (b)    (a) x (b) = (c)             (d)    (c) x (d) = (e)             (f)    (e) x (f) = (g)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1..........  Sequence Listing             9,500               3             28,500               6            171,000            $435        $74,385,000
              in Application.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ 2021 Report of the Economic Survey, published by the Committee on Economics of Legal Practice of the American Intellectual Property Law Association
  (AIPLA); pg. F-27. The USPTO uses the average billing rate for intellectual property attorneys in private firms which is $435 per hour. (https://www.aipla.org/home/news-publications/economic-survey).


                                  Table 2--Total Burden Hours and Hourly Costs to Individuals or Households Respondents
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                       Estimated
                                    Estimated     Responses per  Estimated  annual     time per      Estimated burden   Rate \2\  ($/   Estimated annual
  Item No.          Item             annual        respondent        responses         response        (hour/year)          hour)       respondent cost
                                   respondents                                          (hours)                                              burden
                                            (a)             (b)    (a) x (b) = (c)             (d)    (c) x (d) = (e)             (f)    (e) x (f) = (g)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1..........  Sequence Listing                50               1                 50               6                300            $435           $130,500
              in Application.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\2\ Ibid.

    Estimated Total Annual Respondent Non-hourly Cost Burden: 
$1,483,936. There are no maintenance costs, capital start-up costs, or 
recordkeeping costs associated with this information collection. 
However, the USPTO estimates that the total annual (non-hour) cost 
burden for this information collection, in the form of filing fees and 
postage, is $1,483,936.

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. patent application 
or as part of an international patent application entering the U.S. 
national stage if the sequence listing (i) is not filed via the Patent 
Electronic System or on an electronic medium in compliance with 37 CFR 
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) for U.S. patent applications and 1.492(j) for 
international patent applications entering the national stage, if the 
patent application inclusive of sequence listings filed on paper or on 
a non-compliant electronic medium exceeds

[[Page 34669]]

100 pages, the application size fee is $420 (or $210 for small entities 
and $105 for micro entities) for each additional 50 pages or fraction 
thereof. The average length of a sequence listing filed on paper or in 
PDF format is 150 pages, which results in an average total size fee of 
$1,260 ($630 for small entities, $315 for micro entities) for 
applications that are 100 pages long prior to adding the sequence 
listing.
    As a Receiving Office under the Patent Cooperation Treaty, the 
USPTO collects a basic international filing fee for each international 
application it receives. The basic international filing fee only covers 
the first 30 pages of the international application. For each 
additional application page in excess of 30, a size fee of $16 is added 
to the basic international filing fee. The average length of a sequence 
listing in an international application filed on paper or in PDF format 
is 150 pages. As a result, a paper- or PDF-filed international 
application including a sequence listing incurs an estimated $2,400 
size fee when the application already includes 30 pages prior to adding 
the sequence listing.
    The USPTO charges a fee for the handling of mega sequence listings. 
There are two tiers of fees related to differenent sequence listing 
sizes: one tier for file sizes between 300 MB and 800 MB and one tier 
for file sizes greater than 800 MB.
    The USPTO also charges a 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 3--Filing Fees
----------------------------------------------------------------------------------------------------------------
                                                                  Estimated
         Item No.                          Item                    annual        Filing fee     Non-hourly  cost
                                                                  responses          ($)             burden
                                                                          (a)             (b)    (a) x (b) = (c)
----------------------------------------------------------------------------------------------------------------
1.........................  Size fees under 37 CFR 1.16(s)                130          $1,260           $163,800
                             and 1.492(j), undiscounted
                             entity.
1.........................  Size fees under 37 CFR 1.16(s)                 65             630             40,950
                             and 1.492(j), small entity.
1.........................  Size fees under 37 CFR 1.16(s)                 25             315              7,875
                             and 1.492(j), micro entity.
1.........................  Size fees for international                   420           2,400          1,008,000
                             applications.
1.........................  Submission of sequence listings                30           1,060             31,800
                             of 300 MB to 800 MB
                             (undiscounted entity).
1.........................  Submission of sequence listings                30             530             15,900
                             of 300 MB to 800 MB (small
                             entity).
1.........................  Submission of sequence listings                10             265              2,650
                             of 300 MB to 800 MB (micro
                             entity).
1.........................  Submission of sequence listings                 2          10,500             21,000
                             of more than 800 MB
                             (undiscounted entity).
1.........................  Submission of sequence listings                 1           5,250              5,250
                             of more than 800 MB (small
                             entity).
1.........................  Submission of sequence listings                 1           2,625              2,625
                             of more than 800 MB (micro
                             entity).
1.........................  Late Furnishing Fee for Providing             215             320             68,800
                             a Sequence Listing in Response
                             to an Invitation Under PCT Rule
                             13ter (undiscounted entity).
1.........................  Late Furnishing Fee for Providing             700             160            112,000
                             a Sequence Listing in Response
                             to an Invitation Under PCT Rule
                             13ter (small entity).
1.........................  Late Furnishing Fee for Providing               8              80                640
                             a Sequence Listing in Response
                             to an Invitation Under PCT Rule
                             13ter (micro entity).
                                                              --------------------------------------------------
                               Total.........................  ..............  ..............          1,481,290
----------------------------------------------------------------------------------------------------------------

Postage

    Although the USPTO prefers that the items in this information 
collection be submitted electronically, responses may be submitted by 
mail through the United States Postal Service (USPS). The USPTO 
estimates that the average postage cost for a mailed submission, using 
a Priority Mail 2-day flat rate legal envelope, will be $9.25. The 
USPTO estimates that 1% sequence listings will be submitted in the mail 
resulting in 286 mailing submissions . Therefore, the USPTO estimates 
the total mailing costs for this information collection at $2,646.

IV. Request for Comments

    The USPTO is soliciting public comments to:
    (a) Evaluate whether the collection of information is necessary for 
the proper performance of the functions of the Agency, including 
whether the information will have practical utility;
    (b) Evaluate the accuracy of the Agency's estimate of the burden of 
the collection of information, including the validity of the 
methodology and assumptions used;
    (c) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (d) Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses.
    All comments submitted in response to this notice are a matter of 
public record. The USPTO will include or summarize each comment in the 
request to OMB to approve this information collection. Before including 
an address, phone number, email address, or other personally 
identifiable information (PII) in a comment, be aware that the entire 
comment--including PII--may be made publicly available at any time. 
While you may ask in your comment to withhold PII from public view, the 
USPTO cannot guarantee that it will be able to do so.

Kimberly Hardy,
Information Collections Officer, Office of the Chief Adminstrative 
Officer, United States Patent and Trademark Office.
[FR Doc. 2022-12138 Filed 6-6-22; 8:45 am]
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