The AIPLA brief also states that the Bilski court found the “pre-emption test” (I’m pretty sure the Bilski court never refers to a “pre-emption test” per se; rather it is seeks to apply some test to determine whether there is pre-emption) to be “of limited usefulness,” when the Bilski court actually says, “Analogizing to the facts of Diehr or Benson is of limited usefulness because the more challenging process claims of the twenty-first century are seldom so clearly limited in scope as [in Diehr]; nor are they typically as broadly claimed or purely abstract and mathematical as the algorithm of Benson.” Slip op. at 10.

I do tend to agree that the question raised in Prometheus is not so clear – if all the claim recited were the step of administering the drug to the sick patient to raise his/her metabolite levels, there could be no doubt as to its subject matter eligibility, and so it certainly seems odd (at least at first?) that *adding* a limitation of determining the metabolite levels would suddenly raise a 101 issue.

But it also seems untenable for a patent system to allow a claim requiring only administering a known drug to a sick patient for a known purpose and then measuring an effect of the drug, where the measurement indicates a need to raise or lower a subsequent dosage. Note that the claim does NOT require a step of actually making the needed dosage adjustment indicated by the observed metabolite level; i.e., the only new step can be wholly performed in the mind, and the resulting mental conclusion need not even be heeded. How to reject such a claim, assuming we agree that it should be rejected? 102 or 103 won’t work if a novel, nonobvious mental step is included.*** Perhaps an argument could be made that the transformation resulting from administering the drug is insignificant extra-solution activity because the mental determination is not required to affect the dosage administered in any way. But it is not 100% clear to me what kind of connection is required for “extra-solution activity” to be “significant.” I may be stumped.

***A careful reading of the Prometheus claim shows that it does not even recite a mental step of recognizing that the metabolite level indicates a need to adjust dosage. The clause “wherein a level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood cells indicates a need to increase the amount of said drug subsequently administered” is not a step performed by a human; it is merely a relationship that is inherently either true or untrue whether the person determining the levels is aware of it or not. As recited, a person simply administering the drug and measuring the metabolite levels, having no idea what they mean and no intention to do anything in particular based on the information, could still infringe. So in this case, the relationship between levels and needed dosage adjustment could be ignored for 102 or 103 analysis. But the drafter could have simply rephrased the claim to require someone to actually interpret the determined metabolite levels as indicating a need to adjust dosage, and if that interpretation were new and nonobvious, 102 and 103 would be overcome.

You make a good point regarding the pre-emption test in Bilski. The Federal Circuit certainly did not make the issue crystal clear. In general, I agree with AIPLA’s position on this issue, but some of their language regarding the Bilski court’s characterization of the pre-emption test is probably overboard.