The subject matter eligibility threshold under 35 U.S.C. § 101 continues to stymie efforts at patent enforcement and procurement, particularly in the fields of software and diagnostics. Under § 101, an invention is eligible for a patent if it is a "new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof."
Calls to "do something" have been a steady chorus for several years. What is happening now?
Some pin their hopes on legislative reform. The latest effort was "The Patent Eligibility Restoration Act of 2023" (PERA 2023). This bill was read twice and referred to the Committee on the Judiciary in June 2023. This bill would replace the Alice/Mayo framework and set out the only allowable exceptions in the statute: mathematical formula by itself, mental process, unmodified human gene as it exists in the human body, or an unmodified natural material as that material occurs in nature. There would be no more "judicial exceptions" that have developed in the case law. PERA 2023 would also exclude from patentability any "substantially economic, financial, business, social, cultural, or artistic" process. Legislative efforts, however, will also create their own uncertainty.
Others hold out hope for clarification by the Supreme Court. But the highest court thus far denied all petitions for certiorari on subject matter eligibility since issuing its 2014 opinion in Alice Corp. Pty. Ltd. v. CLS Bank Int'l. This despite urging by the Solicitor for the Court to hear a case on the application of Alice.
Meanwhile at the USPTO, it attempts to provide guidance for examiners and the public at least understand how claims will be treated during prosecution. That guidance, however, is not binding on courts. The USPTO's current eligibility guidance is in the Ninth Edition, Revision 10.2019 of the Manual of Patent Examination Procedure (M.P.E.P.), see Sections 2103 through 2106.07(c). It includes several examples which are worth becoming familiar with if you are engaged in patent drafting and prosecution.
Thus, we remain in a 101 "Land of the Lost" until legislative reform, court clarification, or both happen.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
