[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58772-58773]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-20988]


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DEPARTMENT OF COMMERCE

Patent and Trademark Office

[Docket No.: PTO-P-2022-0031]


Extension of the Cancer Immunotherapy Pilot Program

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

ACTION: Notice.

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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

[[Page 58773]]

immunotherapy to be advanced out of turn for examination. To date, over 
880 petitions requesting participation in the pilot program have been 
filed, and over 650 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 reignition of the National Cancer 
Moonshot initiative, the USPTO is extending the program, with all 
parameters remaining the same, until January 31, 2023. The USPTO will 
also continue to evaluate whether to expand the scope of the pilot 
program and to what extent during this extension period.

DATES: Pilot duration: The Cancer Immunotherapy Pilot Program will 
continue to run until January 31, 2023. Therefore, petitions to make 
special under the Cancer Immunotherapy Pilot Program must be filed on 
or before January 31, 2023.

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 571-272-7711 or 
[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 (9th ed., rev. 10.2019, June 2020), 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 four times through notices 
published in the Federal Register. The most recent notice extended the 
program until September 30, 2022 and requested public comments on 
whether to expand the scope of pilot program and whether to extend it. 
See Extension of the Cancer Immunotherapy Pilot Program and Request for 
Comments, 87 FR 38714 (June 29, 2022) (Extension Notice). The Office 
received one written submission containing three comments from a law 
firm in response to the request for public comments in the Extension 
Notice. The Office appreciates the thoughtful comments. The submission 
is posted at https://www.regulations.gov/document/PTO-P-2022-0019-0001/comment. The USPTO is continuing to evaluate whether to expand the 
program and to what extent.
    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 880 
petitions requesting participation have been filed, and over 650 
patents have been granted under the pilot program. In view of the 
continued interest in the pilot program, the USPTO is hereby extending 
it through January 31, 2023. The extension will enable the program to 
continue without lapse as the USPTO continues its ongoing evaluation of 
whether to expand the program and to what extent. The requirements of 
the pilot program will not be modified at this time.

Katherine K. Vidal,
Under Secretary of Commerce for Intellectual Property and Director of 
the United States Patent and Trademark Office.
[FR Doc. 2022-20988 Filed 9-27-22; 8:45 am]
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