Although Director Iancu’s address primarily aims at the difficulty of determining when a claim is directed to an abstract idea, his precursor guiding light is clearly the late Judge Giles Rich. Notably, Iancu quotes from Judge Rich. These quotes are all taken from Judge Rich’s lengthy opinion In re Bergy, 596 F.2d 952 (CCPA 1979):
“[Judge Rich] said at the time that problems [with s. 101 jurisprudence] can arise due to the unfortunate… though clear commingling of distinct statutory provisions which are conceptually unrelated, namely those pertaining to categories of invention in s. 101 which may be patentable, and to the conditions of patentability [ss. 102, 103, 112].”
“The genius of the 1952 Patent Act, of which Judge Rich is widely viewed as a principal author, was that it characterized the bases for patentability. Our recent s. 101 case law mushes them all up again. As Judge Rich said, this ‘may lead to distorted legal conclusions,’ And it has. And it must end.”
“Section 101 itself lists four categories [of invention]: process, machine, manufacture, and composition of matter. The judicial exceptions should likewise be clearly categorized. As Judge Rich explained, when we deal with s. 101, “the sole question… is whether the invention falls into a named category, not whether it is patentable.’’
“Judge Rich was again perceptive, which he noted 40 years ago that ‘To provide the option of making such a rejection under either 101 or [a condition for patentability] is confused and therefore bad law.’”
When this address was released, I was re-reading In re Bergy, 596 F.2d 952 (CCPA 1979) to prepare for a talk I am giving on Friday. Each of the quotes that Director Iancu used in his address is taken from that opinion, which addressed the question of the patentability of the multi-plasmid bacteria of Chakrabarty and to quote Judge Rich’s description of the question posed by Bergy’s claims:
“Is a man-made, biologically pure culture of a microorganism, for industrial use in manufacturing an antibiotic, whose properties were discovered by applicant, excluded from the terms ‘manufacture’ and ‘composition of matter’ in 35 USC 101 because the microorganism is alive. To give a homely example, it like asking whether a yeast cake or dried yeast powder is a ‘manufacture’ or ‘composition of matter’. Yeast is alive.”
The CCPA’s conclusion was that both Chakrabarty’s “engineered” bacteria and Bergy’s biologically pure cultures of antibiotic-producing bacteria were patent eligible under s. 101. The Government’s petition for cert. was granted. Bergy, however, was subsequently dismissed by the CCPA as moot, leaving only Chakrabarty for consideration. Of course, you know that the Supreme Court affirmed that a live man-made microorganism is patentable subject matter under s. 101.
Confusion exists in voluminous literate generated by Chakrabartry. Some commentators write that the S. Ct. vacated the CCPA opinion and some write – correctly, I think, that the Court remanded the appeal for dismissal as moot. The citation for the order is 444 US 2028 (1980) but I have been unable to obtain a copy. It is perhaps telling that “Bergy II”, as the decision came to be called, was cited by the S. Ct. in Diehr. So hopefully, Examiners who consider rejecting claims to pure strain microorganisms as products of name will refrain in view of what I believe is a precedential decision by the CCPA.
While Director Iancu cites portions of Bergy II to help define the problem with the abstract idea exception, his comments are applicable to the Fed. Cir.’s current position that diagnostic claims that depend on the discovery of the utility of naturally-occurring correlations are not patent eligible without some further “inventive concept.” I think that the reference to Judge Linn’s and Judge Plager’s comments on the failure of the abstract idea test come from Ariosa and Interval Licensing v. AOL., but have not had time to check.
My reading of Director Iancu’s comments (of course) track my own – the courts, the PTAB and the Examiner’s must spend more time on Step 1 of the Mayo/Alice test (or Step 2(a) of the PTO MPEP 2106 patent eligibility flowchart). Iancu would agree that the first question to answer is whether or not the invention falls under the broad enumerated categories of s. 101 – e.g., a diagnostic method or a method of medical treatment is a “process” or an improvement thereof. Then, the Director homes in on a requirement that he believes needs defining – the term “is directed to”:
“To that end, we must first understand what the line is that the court wants us to draw to decide whether the claim is ‘directed to’ an excluded category or not. The proposed new [forthcoming] guidance would explain the Supreme Court jurisprudence taken together effectively allows claims that include otherwise excluded matter so long as that matter is integrated into a practical application. The line, in other words, delineates mere principles, on one hand, from practical applications of such principles on the other.”
While recognizing the dark shadow case by Mayo/Alice Step 2 (or PTO Step 2B), Director Iancu wants guidelines that will keep the well-known, conventional and routine analysis out of Step 1:
“[T]he first step of our analysis does not include questions about “conventionality”, which are addressed in Alice Step 2. That is, it does not matter if the ‘integration’ steps are arguably ‘conventional’; as long as the integration is into a practical application, then the 101 analysis is concluded. There helps to ensure that there is a meaningful dividing line between 101 and 102/103 analysis. A fully ‘conventional’ yet patent eligible claim may still be unpatentable as obvious. But it is better to address such a claim with obviousness law that has been developed over 65 years of practice.”
Of course, it is easy to conclude that method-of-medical treatment claims provide a practical application of the underlying laws of nature as they function in vivo. PTO Guidance structured along these lines would moot the state of the law as explained by Judge Dyk in Genetic Technologies, Ltd v. Meriel, LLC, (Fed. Cir. April 8, 2016). In which first finds that a method to detect an allele in a multi-genetic genetic locus via an amplification step and a detection step is directed to a “routine comparison that can be performed by the human mind.” Instead of then asking if the claimed method – which can be adopted to diagnose monogenic diseases such as cystic fibrosis—involves a practical application of a natural phenomenon, Judge Dyk moves directly into a Mayo/Alice Step 2 analysis since:
“The inventive concept necessary at Step 2…cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself. That is, under the Mayo/Alice framework, a claim directed to a newly discovered [exception] cannot rely on the novelty of that discovery for patent eligibility; instead the application must provide something inventive, beyond mere ‘well-understood, routine conventional activity.’”
Director Iancu has taken the position that if the application of any method/process steps, including well-understood, routine, conventional activity, integrates the judicial exception into a practical application thereof in Step 1 (PTO Step 2A). The s. 101 inquiry is over. Now let’s see him “Make it so”!