Enzo Biochem Inc. et al. v. Applera Corp. et al.


Docket No. 2014-1321

PROST, NEWMAN (D), LINN
March 16, 2015

Brief Summary: DC construction of claims covering both direct and indirect detection of a signaling moiety reversed as inconsistent with the plain language and the specification.

Summary: Applera appealed DC judgment based on jury findings of direct infringement and inducement to infringe, and that the asserted claims were not shown by clear and convincing evidence to lack enablement or written description (claims 1, 8, 67, 68 and 70 of Enzo’s US 5,449,767). The DC construed the claims to cover both direct and indirect detection of a signaling moiety. The FC panel disagreed, finding the claims only encompass direct detection. The opinion explains: “…detecting dideoxyterminators through direct detection, i.e., with radioactive isotopes, is potentially hazardous and expensive. To avoid these drawbacks, nucleotide probes that do not rely on traditional radioactive labels were developed. The ‘767 patent is directed toward these new nucleotide probes.” The DC construed the claims to encompass a nitrogenous base “B” covalently attached to a chemical moiety “A” comprising “at least three carbon atoms and is one or more parts of a signaling moiety, which includes, in some instances, the whole signalling moiety” (defined as “a chemical entity capable of producing a detectable signal”), thereby allowing “for both direct and indirected detection of the claimed compond.” The FC concluded this definition “would read out the phrase ‘component of a signalling moiety’ and would thus impermissibly broaden the claim” (Bicon, FC 2006) (and that that definition would also read out “the requirement that ‘A’ not interfere with the formation of the signalling moiety”). Claim 1 also states that “A…represents at least one component of a signalling moiety”, which Enzo argued was “open-ended language…encompass[ing] multiple embodiments” (citing Howmedica, FC 2008). The opinion explain that “[h]ere, the dispute is whether ‘A’ can comprise the entirety of ‘a signalling moiety’” and “the plain reading of the disputed claim term requires that a signalling moiety be composed of components, of which at least one is ‘A’” which is also supported by the specification (“[T]hroughout the specification, ‘A’ is described as being capable of forming a signalling moiety only in conjunction with other chemicals, never that ‘A’ alone can be a signalling moiety”, also referring to the background section (“[T]he specification’s only discussion of direct detection…was exclusively in the context of discussing how indirect detection is a superior method.”)) It was noted that the DC “concluded, based on expert testimony, that example 9 in the specification was an example of direct detection; however, this argument was not raised by Enzo either in its briefing on appeal or during oral argument” (even so, it was also noted that “this sole factual finding does not override our analysis”). The DC had also relied on claim differentiation, finding that since dependent claims “involved direct detection…independent claim 1 must not be limited to direct detection.” But the opinion explained that “dependent claims cannot broaden an independent claim” (Curtiss-Wright, FC 2006). Thus, the DC claim construction was reversed and the DC finding vacated. Judge Newman’s dissent argued that the “at least one” limitation means direct detection is covered by the claims.

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