On October 7, 2013, the S. Ct. denied cert., ending Intema’s appeal of the Fed. Cir. decision that its patent claims on a method to determine the level of risk of a Down syndrome pregnancy were not patent-eligible subject matter under s. 101. (Supreme Court No. 12-1372). Although a high court ruling on the patent-eligibility of the claims of U.S. Pat. No. 6,573,103 might have clarified the confused state of the law regarding diagnostic method claims, the questions presented by Intema, as set forth in its petition were quite narrow.
Intema argued that measuring two different biomarkers at two different times should meet the Mayo standard for “inventive concept”, because these data gathering steps were per se novel and not routine. Intema also argued that a diagnostic claim should not be required to end with an “action step” such as, what, the patient being advised to, or actually terminating the pregnancy? Finally, Intema spent some space in its brief arguing, half-heartedly it seemed to me, that there was enough transformation of sampling data, as by displaying an ultrasound on a monitor, for the claims to pass the M or T test.
So while Alice v. CLS Bank may lead to some clarification of what an “abstract idea” is or is not, clarification of what qualifies as a patent-eligible diagnostic claim will have to wait for more definitive guidance from the Fed. Cir. I don’t think that the PTO will stop allowing such claims, which are a big part of the race to develop personalized medicine. In fact, one of their examples in the Mayo guidelines of a “good claim” could have come from Intema’s patent. Since Intema was labeled non-precedential by the Fed. Cir., I guess that we will just have to dance – I mean draft – around it for a while longer.