[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 3510-16-P