[Federal Register Volume 87, Number 124 (Wednesday, June 29, 2022)]
[Notices]
[Pages 38714-38715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-13908]


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

DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No.: PTO-P-2022-0019]


Extension of the Cancer Immunotherapy Pilot Program and Request 
for Comments

AGENCY: Patent and Trademark Office, Department of Commerce.

ACTION: Notice; request for comments.

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

SUMMARY: On June 29, 2016, the United States Patent and Trademark 
Office (USPTO) implemented the Cancer Immunotherapy Pilot Program in 
support of the White House's National Cancer Moonshot initiative, which 
sought to accelerate cancer research. The program permits patent 
applications pertaining to cancer immunotherapy to be advanced out of 
turn for examination. To date, over 835 petitions requesting 
participation in the pilot program have been filed, and over 615 
patents have been granted under the program. In view of the continued 
interest in the Cancer Immunotherapy Pilot Program, as well as the 
White House's recent reignition of the National

[[Page 38715]]

Cancer Moonshot initiative, the USPTO is extending the program, with 
all parameters remaining the same, until September 30, 2022. The USPTO 
is also in the process of deciding whether to expand the scope of the 
pilot program and may, additionally, further extend it (with or without 
modifications), depending on feedback from the participants and the 
public, additional continued interest, and the program's effectiveness.

DATES: Comments must be received by July 29, 2022 to ensure 
consideration.
    Pilot duration: The Cancer Immunotherapy Pilot Program will 
continue to run until September 30, 2022. Therefore, petitions to make 
special under the Cancer Immunotherapy Pilot Program must be filed on 
or before September 30, 2022.

ADDRESSES: For reasons of Government efficiency, comments must be 
submitted through the Federal eRulemaking Portal at 
www.regulations.gov. To submit comments via the portal, enter docket 
number PTO-P-2022-0019 on the homepage and click ``Search.'' The site 
will provide a search results page listing all documents associated 
with this docket. Find a reference to this notice and click on the 
``Comment Now!'' icon, complete the required fields, and enter or 
attach your comments. Attachments to electronic comments will be 
accepted in ADOBE[supreg] portable document format or MICROSOFT 
WORD[supreg] format. Because comments will be made available for public 
inspection, information that the submitter does not desire to make 
public, such as an address or phone number, should not be included in 
the comments.
    Visit the Federal eRulemaking Portal website (www.regulations.gov) 
for additional instructions on providing comments via the portal. If 
electronic submission of comments is not feasible due to a lack of 
access to a computer and/or the internet, please contact the USPTO 
using the contact information below for special instructions.

FOR FURTHER INFORMATION CONTACT: For questions regarding this pilot 
program in general, please contact Susy Tsang-Foster, Senior Legal 
Advisor, Office of Patent Legal Administration, Office of the Deputy 
Commissioner for Patent Examination Policy, at 571-272-7711or 
[email protected]. For questions related to a particular 
petition, please contact Gary B. Nickol, Supervisory Patent Examiner, 
at 571-272-0835 or [email protected]; or Brandon J. Fetterolf, 
Supervisory Patent Examiner, at 571-272-2919 or 
[email protected], both of Technology Center 1600.

SUPPLEMENTARY INFORMATION: On June 29, 2016, the USPTO published a 
notice for the implementation of the Cancer Immunotherapy Pilot 
Program. See Cancer Immunotherapy Pilot Program, 81 FR 42328 (Cancer 
Immunotherapy Notice). The pilot program was designed to support the 
global fight against cancer. The Cancer Immunotherapy Notice indicated 
that an applicant could have an application advanced out of turn 
(accorded special status) for examination without meeting all the 
current requirements of the accelerated examination program set forth 
in item VIII of section 708.02(a) of the Manual of Patent Examining 
Procedure if the application contained at least one claim to a method 
of treating a cancer using immunotherapy and the applicant met other 
requirements specified in the Cancer Immunotherapy Notice.
    The Cancer Immunotherapy Notice established that the pilot program 
would run for 12 months, beginning on June 29, 2016. Over the course of 
the pilot program, the USPTO has extended it through notices published 
in the Federal Register. The most recent notice extended the program 
until June 30, 2022. See Extension of the Cancer Immunotherapy Pilot 
Program, 85 FR 41570 (July 10, 2020). In view of the continued interest 
in the pilot program, the USPTO is hereby extending it through 
September 30, 2022. The extension will also allow the USPTO to continue 
its evaluation of the program. The requirements of the pilot program 
have not been modified.
    Various stakeholders from around the world--including independent 
inventors, universities, research institutions, hospitals, medical 
centers, government agencies, and large and small companies--have filed 
petitions to participate in the pilot program. To date, over 835 
petitions requesting participation have been filed, and over 615 
patents have been granted under the pilot program.
    The USPTO is currently deciding whether to expand the scope of the 
pilot program. The USPTO may further extend the program (with or 
without modifications), depending on feedback from the participants, 
additional continued interest, and the program's effectiveness. The 
USPTO welcomes public comment on these topics.

Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2022-13908 Filed 6-28-22; 8:45 am]
BILLING CODE 3510--P