TAKEAWAY: The USPTO recently implemented a new program that expedites examination for technologies for treating and preventing cancer and cancer mortality, in support of President Biden’s Cancer Moonshot.

The USPTO launched the Cancer Moonshot Expedited Examination Pilot Program on February 1, 2023, as a route for applicants to seek fast-track examination of a broad scope of cancer-related technologies. The new program replaces the USPTO’s Cancer Immunotherapy Pilot Program (known as “Patents 4 Patients”), which was first implemented in 2016. The new program is scheduled to run until January 31, 2025, or the date by which the USPTO accepts 1,000 grantable petitions (whichever is earlier).

In contrast to the Cancer Immunotherapy Pilot Program, which was limited to methods of treating cancer using immunotherapy, the new Cancer Moonshot program covers a wider range of eligible technologies. To qualify, applications must claim at least one of the following methods:

  • treating or reducing the incidence of a cancer using an immunotherapeutic compound or composition (cancer immunotherapy method)
  • treating a cancer by targeting specific genetic markers or mutations using a specific pharmaceutical composition
  • treating a rare or childhood cancer using a specific pharmaceutical composition
  • detecting or treating a cancer using a medical device specifically adapted to detect or treat the cancer
  • treating a cancer by administering a specific pharmaceutical composition wherein the method comprises a step to diagnose the cancer
  • treating a nicotine dependency and promoting smoking cessation by administering a specific pharmaceutical composition

The application must be an 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 (reissue applications do not qualify). In addition, the application must contain no more than three independent claims and no more than twenty total claims, and must not contain any multiple dependent claims.

Further information is available here, including a request form for applicants.