WEGNER TO LEE: A FOUR-STEP PROGRAM TO RESOLVE 101 QUESTIONS

On December 23rd, Harold (“Hal”) Wegner sent Director Lee a one-page Vision of Patent-Eligibility “Trees”, Not the “Forrest” (attached). A very brief summary of his proposed 4-step process might read:

1) Is any element of the claim being examined one of the three judicial exceptions to 101?

2) If “yes”, is the claim to a combination of steps or elements that renders the claimed invention different from the exception?

3) If “yes”, does the combination [the claim taken as a whole] yield an ‘inventive step’? This requires an obviousness search and examination, and

4) If “yes”, the invention is both patent-eligible under s. 101 and nonobvious under s. 103 (emphasis is mine).

This is both an admirable attempt to KISS and to conflate, in a good way, the ss. 101/103 analyses that the courts have been [mis]using to find the remaining steps in claims involving, say, natural phenomena, conventional in the art, and then invalidating the claims under s. 101, e.g., in Ariosa the claims to a method of isolating cffDNA were found to be directed to a natural product after the other method steps were dismissed as “old”.

Of course, a one-page attempt to resolve this increasingly thorny briar patch of the law will raise some questions. One is “how will ‘different’ be defined”? The isolation claims in Ariosa certainly had steps that are not found in nature, so the inquiry would presumably continue to the s. 103 analysis. However, what if the claim is to a simple “If A, then B” analysis. According to Justice Breyer in the LabCorp. dissent (and in accord with the PTO Guidelines), such a claim is to a natural phenomenon (elevated HCys correlates to vitamin deficiency) coupled to a second judicial exception, the “mental step” of recognizing what the correlation means. His analysis is faulty, but at least he recognized that such claims comprise two steps, not one.

Until there is recognition that, while the correlation between a biomarker and a future or present pathology in vivo is a natural phenomenon, its discovery, the diagnostic conclusion, can meet the inventive step requirement, the entire art area is in disarray. Some Examiners are rejecting claims that comprise combinations of known diagnostic tests with, e.g., improved predictive properties, as natural phenomena and never reaching obviousness.

We are left with the question of what claim elements will make a process or composition different enough from the natural phenomenon recited in the claim to get us to Step 3, the obviousness determination. I continue to propose that in a claim directed to a diagnostic test, it is the diagnostic conclusion, the “discovery” if you will. In the case of a method of treatment claim it would be the discovery that the  administration of an effective amount of drug A can treat pathology B, even though the effect of A on the pathology is a natural phenomenon.* Without adequate recognition that the “discovery step” provides the “difference” we are as defenseless as Little Red Riding Hood going “Into the Woods” to visit Granny.

*Examiners are also beginning to reject claims to methods of medical treatment which are basically: “If I give the patient bioactive compound A, it will have an in vivo effect B” as attempts to claim natural phenomena that occur in vivo, and ignoring the “discovery” or “recognition” part of the claim entirely, even if A is not a natural product (!). (Remember, the Mayo claims began with method of treatment steps.) Wagener to Lee: Vision of Patent-Eligibility “Trees”, not the Case Law “Forest”

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