Does the “Patent Eligibility Restoration Act of 2023” Revive Diagnostic Claims?

On June 22, Senator Chris Coons, along with Thom Tillis introduced the “Patent Eligibility Restoration Act of 2023” (hereinafter “the Act”) to amend 35 USC s. 101 to clarify the scope of patent-eligible subject matter. Section 100 would be amended to delete “includes a new use of a known process” and insert to s. 101(b) “includes a use, application, or method of manufacture of a known or naturally occurring process.” A section (k) would be added to define the term “useful” as meaning that the invention or discovery has a “specific and practical utility” from the perspective of a POSA. So far, so good. The use of a naturally occurring process can be read to cover the use of a naturally occurring correlation, an “If A then B” claim. The mental recognition of the discovery of the utility of a naturally occurring correlation, which leads to a diagnostic conclusion would seem to be included in this broad language.

But now things get a bit sketchy. The Act would abolish all the current judicial, e.g. Chakrabarty, exclusions but would add a set of statutory exclusions that overlap the judicial exclusions in some places. The exclusions include “an unmodified human gene”—good-bye Myriad—and an unmodified natural material as that material exists in nature, e.g., water. This exclusion would not jeopardize diagnostic claims since a per se is not being claimed.

More troublesome, Section C of the exclusions would include a process that “occurs in nature wholly independent of, and prior to, any human activity.” Diagnostic claims are process claims that are based on the recognition of the utility of a correlation that takes place in the body. If a man has an elevated level of PSA he is at risk of developing, or may already have, prostate cancer. But isn’t the discovery of the correlation a “mental process”  that is also patent-ineligible? How much concrete “human activity” must be recited in a claim  to avoid  these exceptions? Please read the Act and tell me I have nothing to worry about.

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