Another test for Bilski’s machine or transformation.

This piece builds on earlier pieces starting June 25, 2009, related to Bilski’s machine or transformation test. Ask yourself the following: would a machine make a difference in the reasoning for declaring this patent’s claim invalid for embracing ineligible suject matter for patenting? 

Take a look at Prometheus Labs. v. Mayo Collab. Serv., Order Civil No. 04cv1200 JAH (RBB) (S.D. Cal. Mar. 8, 2008).  On a motion for summary judgment, the court found the following claim ineligible subject matter for patenting:

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a) administering a drug providing [6-TG] to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of [6-TG] in said subject having said immune-mediated gastrointestinal disorder,

wherein the level of [6-TG] less than [a recited concentration range] indicates a need to increase the amount of said drug subsequently administered to said subject and

wherein the level of [6-TG] greater than [a recited concentration range] indicates a need to decrease the amount of said drug subsequently administered to said subject.

Steps (a) and (b) are in the prior art.  More specifically, the inventors never claimed to have invented administering 6-TG or determining its level.  Regarding step (a), a drug called 6-MP was known to be administered to treat diseases like Crohn’s disease (CD) and ulcerative colitis (UC).  The prior art taught that 6-MP metabolizes to a second product 6-TG.  Regarding step (b), measuring the level of 6-TG is in the prior art, as the patent admits as much (“6-MP metabolites such as 6-TG can also be measured …. (cited prior art reference omitted).”).  Thus, because the combination of steps (a)-(b) are conventional, the last steps represent what the inventor’s discovered, namely, a correlation between the metabolite and treating CD or UC.   

These correlations, recited in wherein clauses, should be taught in med school text books.  In other words, the court reasoned, claim 1 recites the steps necessary for an ordinary doctor to use her inherent knowledge of a fundamental principle.  Before the discovery of the correlation, claim 1 did not exist and doctors were able to administer 6-TG (e.g., via 6-MP) and to determine its concentration.  After the discovery of the correlation and claim 1’s existence, anytime a doctor ordered “administering” and “determining” procedures, the returned results would allow an ordinary doctor to mentally perform the correlation step; it’s her job.  So, claim 1 effectively took away prior art “administering” and “determining” procedures due to the claim language reciting a doctor’s knowledge of the fundamental principle of “correlating.”  Cf. Flook’s claim 1, without the post calculation step (my weblog of June 26, 2009).  You could also reread Metabolite blog (June 30, 2009).

Assume a dependent claim recited that “(b) determining the level of [6-TG]” were performed by a machine.  Would that make the claim Bilski eligible?