Please read my recent post about stage 1 of this proceeding, in which the Judge in 2016 found that the claims to diagnosing Myasthemia Gravis (MG) by adding MuSk to a patient sample and detecting any IgG autoantibody complexes that are formed, e.g., by exposing the binary complexes with a radiolabelled anti-IgG antibody (claims 2 -6). Claim 7 recited adding labelled MuSK to a sample and detecting any binary complexes that are formed.
Despite the recitation of novel compounds/complexes formed by the hand of man – the radiolabelled MuSK, the binary labelled MuSK-antibody complexes or the tertiary MuSK – aniti-MuSK – labelled anti-IgG antibody complexes, the Judge ruled that because the claims are “focused” on a law of nature – the ability of MuSK to bind to IgG autoantibodies – the claims fail step one of the Mayo/Alice test.
In The Cleveland Clinic Foundation v. True Health Diagnostics, the Fed. Cir. panel held that a claim to a diagnostic method for determining a test subject’s risk for atherosclerotic cardiovascular disease (CD) by comparing MPO levels in the bodily fluid of a test subject to levels of MPO in control subjects is a patent-ineligible attempt to claim a law of nature:
“The method then employs the natural relationship between those MPO values and predetermined control values to predict a patient’s risk of developing or having CD. Thus, just like Ariosa, the method starts and ends with naturally phenomena with no meaningful non-routine steps in between–the presence of MPO in a bodily sample is correlated to its relationship to CD. The claims are therefore directed to a natural law.”
For more details, see my recent post on this decision. Continue reading
Before reading this post, please read my post of July 19, 2017 about Millennium Pharms. v. Sandoz, and you will “get” the title. Judges Lourie and Newman both dissented from refusal of the court to rehear the holding in Schering v. Geneva en banc. That panel decision held that inherent anticipation can be found when the missing claim element is, in fact, necessarily present when a prior art process is carried out, even if this fact was unknown to the POSA when the application was filed. Continue reading
In Regeneron Pharmaceuticals v. Merus N.V., Appeal No. 2016-1346 (Fed. Cir., July 27, 2017), a split three-judge panel of Prost, Wallach and Newman (Newman dissenting) affirmed the district court’s ruling that claim 1 of Regeneron’s U.S. Pat. No. 8,502,018 is unenforceable due to inequitable conduct (IC). The ruling was unusual since the court originally stated that it would hold two hearings; one on the materiality of 4 nondisclosed references, and another on the specific intent to deceive element of IC. Claim 1 reads:
“A genetically modified mouse, comprising in its germline human unrearranged variable region gene segments inserted at an endogenous mouse immunoglobulin locus.” Continue reading