Update On Subject Matter Eligibility In The U.S.

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