USPTO Introduces Cancer Moonshot Expedited Examination Pilot Program

The Cancer Moonshot Expedited Examination Pilot Program (the new Pilot) will accord special status (earlier examination) to patent applications directed to technologies to prevent cancer and cancer mortality. The new Pilot replaces the Cancer Immunotherapy Pilot Program, which expedited examination for cancer immunotherapies and had been in place since mid-2016. More technologies will qualify for expedited examination under the new Pilot.

Under the new Pilot, applications with claims directed to qualifying technologies will receive a first office action from the US Patent and Trademark Office (USPTO) earlier than normal. The new Pilot will expedite examination through the Petition to Make Special mechanism. The new Pilot will accept Petitions to Make Special beginning on February 1, 2023, until either January 31, 2025, or the date the USPTO accepts a total of 1,000 grantable petitions under the Pilot, whichever is earlier. An ongoing count of the number of petitions filed and the number of petitions granted under the new Pilot will be available on the USPTO website.

Pilot Eligibility Requirements

Acceptance into the new Pilot requires submission of the following:

• An application which is in the field of oncology or smoking cessation, and includes at least one of the following method claims:
  • A method of treating or reducing the incidence of a cancer using an immunotherapeutic compound or composition (cancer immunotherapy)
  • A method of treating a cancer by targeting specific genetic markers or mutations using a specific pharmaceutical composition (personalized medicine)
  • A method of treating a rare or childhood cancer using a specific pharmaceutical composition; (rare/childhood cancer)
  • A method of detecting or treating a cancer using a medical device specifically adapted to detect or treat the cancer (medical device)
  • A method of treating a cancer by administering a specific pharmaceutical composition wherein the method comprises a step to diagnose the cancer (cancer diagnosis)
  • A method of treating a nicotine dependency and promoting smoking cessation by administering a specific pharmaceutical composition (smoking)

  Note: If the application contains eligible product or apparatus claims, the method claims listed above must contain all of the limitations of the eligible product or apparatus claims.

The application must contain no more than 3 independent claims, no more than 20 total claims, and no multiple dependent claims. In addition, the application needs to be 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.

• A Petition to Make Special Under the Cancer Moonshot Expedited Examination Pilot Program (Form PTO/SB/465). There is no fee for filing this petition.

The USPTO will consider these submissions after their electronic submission. If all requirements are met, the USPTO will grant the Petition to Make Special and the application will be advanced out of turn for the first office action.