On Wed., February 8, 2017, IPO released the report of its legislation task force. Unlike the hundreds of academic analyses of the legislative history of s. 101 – and this report includes another – the Task Force took the further necessary and nervy step of proposing amendments to s. 101 to blunt the impact of the Mayo/Alice rules:

101(a) Eligible Subject Matter: (Minor, though well thought out amendments)…”subject only to the exceptions, conditions and requirements set forth in this Title.

101(b) Sole Exception to Subject Matter Eligibility: A claimed invention is ineligible under subsection (a) if and only if the claimed invention as a whole, as understood by a [POSA] to which the claimed invention pertains, exists in nature independently of and prior to any human activity, or exists solely in the human mind.

101(c) Sole Eligibility Standard: The eligibility of a claimed invention under subsections (a) and (b) shall be determined without regard as to the requirements or conditions of sections 102, 103, and 112 of this Title, the manner in which the claimed invention was made or discovered, or the claimed invention’s inventive concept.”

Although “or exists solely in the human mind” is intended to exclude abstract ideas, it is not necessary. An invention that exists solely in the human mind has no tangibility. The term “abstract idea” is a tautology; all ideas are abstract until they are made tangible (if they can be). I do like the word “solely”, since it seems to recognize that a claim can contain a thinking step – among others – and not be labelled an abstract idea.

My primary quarrel with this brave attempt to amend s. 101 is that it can be read to except diagnostic methods and methods of medical treatment from patent eligibility. This ambiguity, if it is even that, comes when the legal fate of both diagnostic tests and methods of treatment, hangs in the balance. The PTO guidance on 2014 and 2016 instruct that diagnostic tests are not patent-eligible but methods of medical treatment are. Justice Breyer wrote that simple diagnostic tests (If A, the B) are not patent-eligible. The Fed. Cir. seem to be somewhere in the middle. Judge Dyk, in Meriel, said “not patent eligible.” Other judges have ruled that diagnostic claims are not patent-eligible, but either the measuring technique and/or the condition diagnosed were written in very broad terms. (See, for example, Myriad or Ariosa.) Judge Newman was the lone dissenter from the decision not to re-hear Ariosa en banc, but it’s time.

A correlation (of high homocysteine then low cobalamin or the body’s use of its immune response to inhibit a dysfunctional cell) can exist in vivo without any human intervention. The correlation only becomes useful when it is discovered, and used and claimed as a diagnostic method or as a method of treatment. In other words, the inventive discovery step must be separated from the naturally occurring correlation.

My addition to s. 100 would be brief: “The term ‘process’ includes a method that is based on the discovery of the utility of a naturally occurring correlation.” The currently-proposed amendments seem to be aimed at protecting software and, to some extent, business methods. I look forward to comments from the biotech/pharma practitioners and researchers.

This article was originally published on Patents4Life.com.

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