As per a notice[1] (“the notice”) dated December 9, 2022, the United States Patent and Trademark Office (“USPTO”) has announced that beginning February 1, 2023, an expedited examination program will be launched to replace the Cancer Immunotherapy Pilot Program.[2] Under the new Cancer Moonshot Expedited Pilot Program (“the new pilot program”), accepted applications pertaining to broadened scope of qualifying technologies will be accorded special status until a first Office action.[3] In other words, accepted applications will be advanced out of turn for examination. The pilot program will run until the earlier of either January 31, 2025, or the date that a total of 1000 grantable petitions have been accepted under the pilot program.
Termination of the Cancer Immunotherapy Pilot Program and Implementation of the New Pilot Program
The new pilot program covers a wide range of eligible technologies, in contrast to the Cancer Immunotherapy Pilot Program, which required the application to contain a claim to a method of treating cancer using immunotherapy and the election of that method claim for examination.[4] The new pilot program is an expansion and replacement of the Cancer Immunotherapy Pilot Program, in view of the continued success of the latter.
Eligible Method Claims
Under the new pilot program, applications must be in the field of oncology or smoking cessation and must contain at least one method claim that meets the eligibility requirements of the program,[5]. The application must claim an invention in at least one of the following technologies:[6]
(1) A method of treating or reducing the incidence of a cancer using an immunotherapeutic compound or composition (cancer immunotherapy method);
(2) A method of treating a cancer by targeting specific genetic markers or mutations using a specific pharmaceutical composition;
(3) A method of treating a rare or childhood cancer using a specific pharmaceutical composition;
(4) A method of detecting or treating a cancer using a medical device specifically adapted to detect or treat the cancer;
(5) A method of treating a cancer by administering a specific pharmaceutical composition wherein the method comprises a step to diagnose the cancer; and
(6) A method of treating a nicotine dependency and promoting smoking cessation by administering a specific pharmaceutical composition.
Eligibility Requirements for Petitions to Make Special under the New Pilot Program
To obtain special status under the new pilot program, Applicants must satisfy certain conditions in a Petition to Make Special. Applications must be a non-reissue (original), nonprovisional utility application filed under 35 U.S.C. § 111(a),[7] or an international application that has entered the national stage under 35 U.S.C. § 371.[8]
The application may not contain more than 3 independent claims and 20 claims in total. In addition, multiple dependent claims are not permitted. Throughout pendency, an application with special status under the new pilot program must meet the above limits and the petition must include a statement that the applicant agrees not to exceed the program claim limits or add any multiple dependent claim limits throughout the pendency of the application.
In addition, there must be at least one method claim in the application that meets the eligibility requirements previously discussed. The petition must further include a statement that special status is being sought because the application is limited to the field of oncology or smoking cessation and contains at least one method claim that meets the eligibility requirements of the new pilot program. In addition, the petition must include a statement that the applicant agrees not to cancel all method claims that meet the eligibility requirements of the pilot program throughout the pendency of the application.
Commentary
The new pilot program aims to support the renewed United States Cancer Moonshot initiative that aims to reduce the cancer mortality rate by at least 50% within 25 years.
For more information on the Cancer Moonshot Expedited Pilot Program or to obtain IP protection for your assets, please contact a patent agent at PCK Intellectual Property.
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