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Life Science Patenting to Iancu – “We need help too!”

In his remarks presented at the recent 10th Annual Patent Law & Policy Conference at Georgetown University Law School, USPTO Director Andrei Iancu outlined the analytical framework for the new, eagerly awaited, PTO Guidance on patent eligible subject matter. Although his remarks touched on the judicial exception for claims directed to “pure discover[ies] of nature, like gravity or electromagnetism, and mentioned technologies such as computer viral screening and methods of medical treatment, the focus of his remarks was on the patent eligibility of “prohibited abstract ideas.”

He defined abstract ideas as falling into one of three categories: 1) mathematical concepts, 2) certain methods of organizing human interactions… [such as] advertising, marketing and sales activities [e.g., Bilski or Alice] and 3) mental processes, “which are concepts performed in the human mind, such as forming an observation, evaluation, judgment or opinion.” Director Iancu then focused on the overriding importance of determining whether or not a claim is simply directed to a judicial exception or is “a practical application of otherwise excluded subject matter….for example, we should be able to differentiate between [a claim drawn to] electromagnetism itself, on one hand, [and claims to] toys that communicate with each other using electromagnetic signals, on the other.” Not surprisingly, he cited Diehr approvingly.

His proposed analytical framework for examiners attempting to resolve the s. 101 question is first, to “look to see if the claims fall within the four statutory categories: process, machine, or composition of matter (This is not new, we always do this). If so, examiners then determine if the claims recite subject matter within one of the judicial exceptions, categorized as I just described (This is the new approach.)” If they do not the Examiner moves on to ss. 102, 103 and 112. If they do, the examiners “would assess whether the claims integrate the exception into a practical application of the otherwise excluded material. If so, the claim passes the 101 test and eligibility analysis is concluded.”

While Director Iancu clearly believes that this “new approach” will meet the Mayo/Alice test as it is currently applied to abstract ideas, it is far from clear how such an analytical framework will pull us out of the slough of despair we are slogging through due to Federal Circuit decisions like Mayo (Are the claims to the abstract idea of thinking about the effects of drug metabolism or are they drawn to a phenomenon of nature or are they a hybrid of some sort), Ambry (ssDNA primers are not patentable after Myriad and the identification of a gene mutation is a natural phenomenon—even though in Myriad the identification step was called an abstract idea) or Merial (Detection of coding region alleles using the law of linkage disequilibrium), much less Ariosa (Method of detecting cffDNA from a new source). And can anyone cite a Fed. Cir. decision that holds that, because human genes are patent ineligible, so are isolated polypeptides?

I am aware that the Director is an “electrical guy” and that the abstract idea question has bedeviled the software industry, but the diagnostic IP landscape has been just about clear cut as well. The Fed. Cir. has held that the recognition/discovery that levels of a biomarker like PSA elevated over a certain level are predictive of cancer, simple “If A, then B” claims, are not patent eligible because the mental step of recognizing the importance of the correlation cannot meet step 2 of the Mayo/Alice test. I submit that Director Iancu’s inclusion of “forming an observation” as an abstract idea is not going to pull us out of this legal quagmire. For some time, examiners have been disregarding claim limitations involving observing natural phenomenon as mental process steps. Once the “discovery” part of a diagnostic claim is deleted, it is easy to call the remainder of the claim a natural phenomenon, even if it is a correlation first discovered by the inventor, and is of great value to humanity.

Furthermore, although the Director seems to think that it is easy to tell if a claim is directed to a natural phenomenon such as a product of nature, we do not even have consistent case law that tells us when isolation and purification of, say, an antibiotic producing bacterium from a source such as the soil, so that the bacterium and the antibiotic have valuable practical applications, will amount to a patent eligible invention.

No one even seems to know if Bergy II is precedential, except perhaps the Supreme Court, that cited it with approval in Diehr. The current Supreme Court could have reaffirmed the importance of Bergy II by granting cert. in Ariosa, but they passed. The fact that Director Iancu cites and has cited Judge Giles Rich – who authored Bergy II—with admiration, will not fix this legal tangle, but I am certainly willing to support any efforts he makes to get us out of this anti-patent vortex.


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