To support the National Cancer Moonshot initiative, the USPTO launched the Cancer Moonshot Expedited Examination Pilot Program on February 1, 2023. The new program replaces the Cancer Immunotherapy Pilot Program, which expedited examination for eligible patent applications pertaining to methods of treating cancer using immunotherapy. The new program is open to a broader range of patent applications, including those directed to other treatment modalities and some cancer detection technologies, but has additional procedural requirements applicants should take note of.
The national Cancer Moonshot initiative was created in 2016 and led by then Vice President Biden. As president, Biden has set a new goal, according to the White House, “to cut the death rate from cancer by at least 50% over the next 25 years, and improve the experience of people and their families living with and surviving cancer.” According to the USPTO, the Cancer Moonshot Expedited Examination Pilot Program will “support the renewed national Cancer Moonshot initiative by providing a broader scope of qualifying technologies.”
As explained in this Federal Register Notice, the Cancer Moonshot Expedited Examination Pilot Program began on February 1, 2023 and replaced the Cancer Immunotherapy Pilot Program, which expired on January 31, 2023. The new program provides a mechanism for expedited review of patent applications by advancing qualifying applications out of turn to decrease the time to first Office Action. Notably, the new program broadens the scope of qualifying technologies to include technologies relating to the treatment of cancer by modalities other than immunotherapy and also includes some technologies relating to cancer detection.
Under the Cancer Moonshot Expedited Examination Pilot Program, applications must be in the field of oncology or smoking cessation and must contain at least one of the following types of method claims:
Under the following circumstances, product and/or apparatus claims may be included in the new program:
As a threshold matter, in order to be eligible for the program, the specification, claim(s), and abstract must have been submitted in DOCX format at the time of filing or national stage entry, and the application may not have been filed with a non-publication request.
To apply to participate in the program, an applicant must file a petition to make special prior to issuance of a first Office Action (including a restriction requirement) that meets the following criteria:
The program will be in effect until January 31, 2025, or the date on which the USPTO accepts a total of 1000 grantable petitions, whichever is earlier.
Additional information about the program can be found here.
At the time the Federal Register Notice was published, the USPTO was on the verge of imposing a surcharge for not filing a new U.S. patent application in DOCX format. Thus, at that time, the DOCX filing requirement only imposed an additional requirement on U.S. national stage applications (which will not be subject to the non-DOCX surcharge). However, now that the DOCX surcharge has been delayed, the DOCX filing requirement is an additional requirement for all applications that must be met at the time the application is filed.
(A similar DOCX requirement pertains to the Climate Change Mitigation Pilot Program.)