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PTO Expands the Scope of the Immunotherapy Pilot Program

The PTO’s Cancer Immunotherapy Pilot Project, begun in 2016, has been deemed a success. It permitted an applicant claiming a method to treat cancer using immunotherapy to file a petition to accelerate issuance of the first Examination Report. When the program expires, on Jan. 31st, it will be replaced by a structurally similar program entitled “the Cancer Moonshot Expedited Examination Pilot Program” which will broaden the scope of qualifying technologies, to include certain product or apparatus “use” claims.  87 C.F.R. 75608, Dec. 9th 2022.

Of the six categories of inventions listed, category 1 covers “cancer immunotherapy” methods of treatment. Category 2 covers a method of treating cancer by administering a “specific pharmaceutical” that targets specific genetic markets or mutations. Category 3 specifies that the “specific pharmaceutical composition” is used to treat a rare or childhood cancer.  The constant use of “specific” seems intended to block applicants from pursuing method claims using compounds that have multiple utilities, or modes of action, not all of which relate to cancer treatments.

More interesting to a patent eligibility camp follower like me are categories 4 and 5. Point 4 covers “a method for detecting or treating cancer using a medical device specifically adapted to detect or treat the cancer”. Note the important “or” conjunction. Detecting cancer is a diagnostic method and, as such, is not patent eligible, since it has been repeatedly defined as simply as the recognition of a naturally occurring correlation carried out by conventional means. The legal needle that the PTO is attempting to thread is the requirement that the “medical device” is both a concrete entity, and that the device itself is “specifically adapted” to detect cancer. (At least it doesn’t say that a “specific cancer” must be detected.) A medical device is at least not an abstract idea, and the method of using it to diagnose can be put in a dependent claim. By now you should recall that “concreteness” alone has not saved devices like a dual lens camera or a driveshaft dampened by internal baffles. The Fed. Cir. has been lenient to medical devices that are improvements over the prior art including a novel use of flow cytometry or detecting abnormal heart beats using a soup-upped ECG.

Category 5 of the Program is “A method of treating cancer by administering a specific pharmaceutical composition, wherein the method comprises a step to diagnose the cancer.” Apart from how the PTO will define “a specific pharmaceutical composition” this point is a clear nod to the patent ineligibility of diagnostic assays per se, as well as the recognition that diagnostic methods can be piggy-backed on to method of medical treatment claims. At least, the Fed. Cir. has clearly stated that methods of medical treatment are patent eligible.

I won’t elaborate on the specific parts and procedures necessary to petition for the Moonshot program, except to note that the application cannot be a provisional application. Apart from the pages of petition formal requirements, this Program could have included a statement that Examiners  should presume that Program-worthy claims are to be presumed to be patent eligible. Now there’s a New Year’s Resolution we could all agree on.


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