Introducing the New USPTO Cancer Moonshot Expedited Examination Pilot Program

January 2023

Starting from February 1, 2023, the USPTO will begin the new Cancer Moonshot Expedited Examination Pilot Program that advances out-of-turn applications that are directed to oncology or smoking cessation. This new program will replace the Cancer Immunotherapy Pilot Program that has been in place since 2016, and covers more technologies than only cancer immunotherapies.

Applications accepted into the new program will be accorded special status in Examiner’s docket and enjoy expedited examination until the first Office action is issued (including restriction requirements). The new program is available for a non-reissue (original), nonprovisional utility application filed under 35 U.S.C. 111(a), or an international application that has entered the national stage under 35 U.S.C. 371.

To qualify for the new program, an application must claim an invention pertaining to one or more of the below eligible technologies:

  1. Cancer immunotherapies;

  2. Personalized medicine to treat a cancer by targeting specific genetic markers or mutations using a specific pharmaceutical composition;

  3. Cancer treatments for rare cancers, including all childhood cancers, using a specific pharmaceutical composition;

  4. Detecting or treating a cancer using a medical device specifically adapted to detect or treat the cancer;

  5. Treating a cancer by administering a specific pharmaceutical composition after diagnosing the cancer; and

  6. Treating a nicotine dependency and promoting smoking cessation by administering a specific pharmaceutical composition.


Applicants wishing to participate in the Cancer Moonshot Expedited Examination Pilot Program should contact an agent to help them file a petition to make special with the USPTO. Compared to regular accelerated examination, the new program has less stringent submission requirements. For example, it is free (no fees!) and it waives the requirement of a preexamination search report. More detailed information about the program’s exact requirements can be found here.

The program is set to run until either January 31, 2025, or the date the USPTO accepts a total of 1,000 grantable petitions, whichever is earlier.

If you would like to know whether your invention may benefit from the new program, or if you have any inquiries, please feel free to reach out to us at


This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.