I recently took another look at the Joint AIPLA-IPO Proposal on Patent Eligibility that was prompted by the scheduling of a discussion meeting by the Minnesota Intellectual Property Law Association. I confess that I did not participate in either the AIPLA’s proposal process and cannot attend the upcoming MIPLA meeting but, nonetheless I have some thoughts.
The Joint Proposal to amend section 101 reads as follows:
“Eligible Subject Matter
(a) Whoever invents or discovers, and claims as an invention, any useful process, machine, composition of matter, or any useful improvement thereof, shall be entitled to a patent therefor, subject only to the conditions and requirements set forth in this title.
Sole Exceptions to Subject Matter Eligibility
(b) A claimed invention is ineligible under subsection (a) if and only if the claimed invention as a whole (i) exists in nature independently of and prior to any human activity or (ii) is performed solely in the human mind.
Sole Eligibility Standard
(c) The eligibility of a claimed invention under subsections (a) and (b) shall be determined without regard to:
1. The requirements or conditions of sections 102, 103, and 112 of this title;
2. the manner in which the claimed invention was made or discovered; or
3. whether the claimed invention includes an inventive concept.”
I think that defining what is ineligible subject matter is riskier that trying to define what subject matter is eligible. Here’s why. Consider the dire straits that claims to diagnostic methods have been drawn into by the Mayo/Alice test and case law like Meriel and Ariosa. The Federal Circuit has held that naturally occurring correlations, such as that between the levels of a biomarker and the presence of prostate cancer, are natural phenomenon. These correlations occur entirely within the human body independently of any human intervention. The Fed. Cir. judges seem to have fashioned a rule that the discovery of the utility or significance of the correlation cannot satisfy the “inventive concept’ requirement of the Mayo/Alice test.
Does this proposed amendment banish this type of rejection? If you are claiming a diagnostic test based on the discovery of a naturally-occurring correlation, it could be argued that you are simply claiming something that exists in nature “independently of, and prior to any human intervention.” Does the “human activity” that is the recognition of the utility of the correlation – a mental step given no patentable weight by some judges — remove the claimed discovery from the realm of natural phenomenon or does it leave the discovery in the category of a natural phenomenon that continues to occur unaffected by such “human activity”? Methods of medical treatment certainly require “human activity” and so does the isolation and purification of a product of nature, but does the language of the proposed amendment bullet-proof simple “If A, then B” diagnostic claims from natural phenomena rejections? I don’t think that Justice Breyer would say “yea” if such a claim reached the S. Ct.
Stated positively, an amendment to s. 101 might read, “A ‘process’ shall include the discovery of the utility of a naturally-occurring correlation.” I assume that an invention that occurs “solely in the human mind” is intended to deal with attempts to claim abstract ideas. Since Director Iancu apparently believes he can arrive at PTO Guidance that will cabin the reach of such rejections, I will not expand my trepidation at this point.