Patentable Subject Matter in US 7396654 as claimed

Question

Any Prometheus v. Mayo issues with this?

Answer 1

Yes. This patent issued on July 8, 2008--almost four years prior to the decision you cite, provided in all its glory here: http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf

It is one thing to identify an issue, and quite another to determine its significance. A more interesting question is what would happen if this patent were litigated.

Claim one of your patent appears below:

1. A method of determining the presence of traumatic brain injury (TBI) in a subject, comprising:

measuring the amount of ubiquitin C-terminal hydrolase L1 (UCH-L1) in a sample of cerebral spinal fluid (CSF) or blood from a subject at a time within and up to seven days after occurrence of a suspected TBI; and, comparing the amount of UCH-L1 in said sample with the amount of UCH-L1 in a respective sample from an uninjured subject wherein a higher amount of UCH-L1 in the subject sample relative to the amount in a CSF or blood sample from the uninjured subject is indicative of TBI in the subject suspected of having the TBI.

Initially, it is difficult to overlook the similarity between the correlations relating to concentration, here and in Mayo v. Prometheus. However, there are important differences. For one, Mayo could be construed narrowly to apply only to the specific claimed phenomenon relating to the relationship between concentration and efficacy. Also, here it is possible that dependent claim 3 requiring a separation of blood plasma might otherwise move the claim within the purview of 35 U.S.C. 101, as the physical screening steps did in Association for Molecular Pathology v Myriad Genetics, Inc.

A lot would depend on the district judge presiding over the trial. It may not be possible to predict the outcome at the trial level, but some district judges might be inclined to interpret Mayo narrowly. On appeal, however, it is likely that at least some of the judges would be looking for an opportunity to temper the effect of Mayo as it did in Myriad. This particular patent claim might present an interesting opportunity.

This body of law is far from settled. The uncertainty in any litigation should be strong motivation for both sides to settle.