The 2019 Revised Subject Matter Eligibility Guidance published on January 7th purported to revise the procedures for determining whether a patent claim or patent application claim is “directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas) under step 2A” of the USPTO’s Mayo/Alice Rule Guidance in two ways. First, the Revised Guidance seeks to clarify just what an abstract idea is by stated that abstract ideas can be grouped as, e.g., mathematical concepts, mental processes and the like. More important to life sciences patenting, the Revised Guidance explains that a patent claim that recited a judicial exception is not ‘directed to’ the judicial exception if the judicial exception is integrated into a practical application of the judicial exception.” If the claim is [[not]] directed to a judicial exception, the dreaded 2B analysis must be carried out.
The majority of the Fed. Cir. panel clearly disagrees with this Revision in the case of any diagnostic claim that recites a naturally occurring correlation, along with the manipulative steps required to reach a diagnosis. The majority of the panel in Athena v. Mayo – and perhaps a majority of the Fed. Cir. Judges – inevitably find that a diagnostic claim that recites the application of a naturally occurring correlation reach a diagnostic conclusion is directed to a natural law, despite the presence in the claim of the steps wherein the “hand of man” is applied to convert the discovery of the in vivo correlation into a practical application of the natural law. Once the claim is found to be directed to a such a correlation, which is a natural law, the court moves on the Step 2B, in which it examines the remaining steps – sampling, measuring the biomarkers in question and comparing them to a reference amount of the biomarker, and drawing a diagnostic conclusion from the data – in isolation, to see if they represent an “inventive step” apart from their application to reach a diagnostic conclusion. In other words, the recognition of the utility of the in vivo correlation cannot provide the required “inventive step” when applied in vitro, unless there is a second “invention” that arises when the in vitro assay is carried out.
This approach to determining whether or not the applicant or patentee is attempted to monopolize a natural law fundamental clashes with the “recite/practical application” approach of the Revised Guidelines. Perhaps the court will distinguish – and accept—the PTO approach when evaluating software and computer system claims accused of attempting to patent an abstract idea, but that will be of little comfort to Athena, Ariosa, Cleveland Clinic or Cepheid (for cites, see fn. 7 of Judge Newman’s dissent in Athena.
By now, you may have realized that I am paraphrasing Judge Newman’s dissent in Athena. I would gladly quote most of it, but here is a taste:
“The [patentees] did not patent their scientific discovery of MuSK autoantibodies. [Ed.’s note: Could they have?] Rather, they applied this discovery to create a new method of diagnosis, for a previously undiagnosable neurological condition.”
“The panel majority ignores [the specific steps by which the diagnostic method is performed], and instead holds that ‘claims 7-9 are directed to a natural law because the claimed advance was only in the discovery of a natural law, and that the additional recited steps only apply conventional techniques to detect that natural law…This analysis of patent-eligibility is incorrect, for the claim is for a multi-step method of diagnosing neurotransmission disorders…by detecting autoantibodies using a series of chemical and biological steps as set forth in the claims. Eligibility is determined for the claim considered as a whole, including all its elements and limitations. Claim limitations cannot be discarded when determining eligibility under Section 101.”
“It is incorrect [and not required by the Mayo/Alice test] to excise from the claims any steps that are performed by conventional procedures. This is misconstruction of claims and misapplication of Section 101… Applied to the [patent in suit], the claimed method is a new method of diagnosing [MG]. After eliminating the ‘conventional’ procedures, my colleagues rule that this new method is a ‘law of nature’. However, these inventors are not claiming the scientific fact of a newly described autoantibody; they are claiming a new multi-step diagnostic method. This is not a law of nature, but a man-made reaction sequence employing new components in a new combination to perform a new diagnostic procedure.” Slip op. at 4-5.
“The majority misconstrues the claims, in holding that claims 7-9 are directed to the ‘concept’ of ‘the correlation between the presence of naturally-occurring MuSK autoantibodies in bodily fluid and MuSK-related neurological diseases like MG.’…The claimed method determines whether this correlation is present, for diagnostic purposes but the concept itself is not claimed.”
“Section 101 does not turn on whether any claim steps are ‘standard techniques’. The appropriate analysis of the role of conventional process steps in claims to a new method is under Sections 102 and 103, not Section 101.”
Myriad, Ariosa and Ambry aside, think how different our IP landscape would be today if the Fed. Cir. in Cleveland Clinic had adopted “Newman’s First Law of Patent-Eligibility”, and ruled that a diagnostic claim is patent eligible as a practical application of the discovery of an in vivo correlation, or even if the Fed. Cir. had ruled that an inventor’s recognition of the utility of an in vivo correlation could indeed provide the inventive concept requirement of Mayo/Alice Step 2B, apart from the conventionality or lack thereof in the “operational steps.” Of course, if wishes were horses, beggars would ride, but I don’t think that Director Iancu is hearing the sound of hoofbeats.