In my last post on Prometheus, I concluded: It is hard to think of a diagnostic assay claim that does not either detect the +/- presence of a marker (like anti-HIV antibodies) or involve the comparison of the level of a marker of some sort (like homocystine or PSA) with a benchmark level (which could be normal or pathological)…all of these assays seem to have been converted into no more that the discovery of laws of nature” with unpatentable pre-solution and post-“processing” steps. I wrote that the key phrase in the decision may be that the steps were “specified at a [too] high level of generality.”
But how much generality is too much generality? Justice Breyer teases patent attorneys like Gypsy Rose Lee at her best – offering a glimpse of a rule, then whisking it away from an ever more agitated audience. For example, at page 18 of the slip op. he writes:
“We need not, and do not, now decide whether were the steps at issue here less conventional, these features [the administration, assay and indication steps] of the claims would prove sufficient to invalidate them. For here, as we have said, the steps add nothing of significance to the natural laws themselves.”
The reader of this opinion keeps waiting for Justice Breyer to give us some hint of the degree of unconventionality or amount of significance that would suffice in the context of a diagnostic test “to transform an unpatentable law of nature into a patent-eligible application of such a law”, but none is forthcoming. Instead, there is a lengthy discussion of a UK decision – Neilson v. Haford – that involved an improved method of blowing air into a furnace by using a pre-heated receptacle chamber for the air. Breyer writes: ‘thus, the claimed process included not only a law of nature but also several unconventional steps (such as inserting the receptacle, applying heat to the receptacle externally, and blowing the air into the furnace that confined the claims to a particular, useful application of the principle.” Slip. op. at 14-15.





