In re: Ethicon, Inc., No. 2015-1696, 2017 U.S. App. LEXIS 4 (Fed. Cir. Jan. 3, 2017) (Before Newman, Lourie, and Dyk, J.) (Opinion for the court, Lourie, J.) (Dissenting opinion, Newman, J.)(The Federal Circuit rejected Ethicon’s argument that the Board’s obviousness finding impermissibly relied on hindsight. In dissent Judge Newman disagreed, saying without hindsight there would have been no motivation to combine.)
In a January 3, 2017 decision, the Federal Circuit affirmed a decision by the Patent Trial and Appeal Board (“The Board”) in an inter partes reexamination affirming the examiner’s obviousness finding.
Ethicon, Inc. (“Ethicon”) owns the ’844 patent, which relates to intraluminal medical devices for the local delivery of drugs, e.g., drug-eluting stents, and methods for maintaining drugs on those devices. The patent teaches that stent coatings themselves, and stent coatings delivering drugs locally, may be capable of reducing resentosis, the gradual re-closure of a blood vessel. Ethicon sued Boston Scientific SCIMED and Abbott Laboratories (collectively, “Requesters”) for infringement of the ’844 patent. The Requesters filed separate requests for inter partes reexamination of the ’844 patent. The PTO merged and granted the requests, and the examiner rejected claims 1-17 and 19-23 as obvious over the “Tuch,” “Tu,” and “Lo” patents. The examiner found that Ethicon’s evidence regarding objective indicia of nonobviousness was insufficient. Ethicon appealed to the Board, and the Board affirmed, and Ethicon appealed to the Federal Circuit.
The Federal Circuit rejected Ethicon’s argument that the Board’s obviousness finding impermissibly relied on hindsight and failed to provide any reason why one of ordinary skill in the art would have combined the prior art references to create the claimed invention. The Court emphasized that KSR Int’l Co v. Teleflex, Inc. does not require an explicit teaching, suggestion, or motivation in the references. The Board made sufficient factual findings from substantial evidence under the circumstances to support its obviousness conclusion. First, Tuch taught that elasticity and biocompatibility are useful polymer characteristics and that coatings with low elasticity are problematic. Second, the components of Tu and Lo supported the Board’s combination of the three references to address the elasticity problem described by Tuch. Tu and Lo disclosed an 85:15 weight ratio of VDF:HFP elastomers, which low described as “optimal” and Tu disclosed that a VDF:HFP elastomer “promotes the elasticity [and] strength” of components for medical devices.
The Court rejected Ethicon’s argument that the Board was mistaken in certain factual findings. Tuch teaches that elasticity is a useful polymer characteristic and that coatings with low elasticity are problematic. Tu teaches that its multilayer elastomer material has a “very broad application in biomedical devices, such as . . . heart valve leaflets.” The Court found no error in the Board’s reliance on Lo, applied for “teaching the properties of VDF:HFP” at different ratios of copolymer. Substantial evidence supported finding that Lo’s teachings are “reasonably pertinent to the particular problem with which the inventor is involved.” Further, “[t]he normal desire of artisans to improve upon what is already generally known can provide the motivation to optimize variables such as the percentage of a known polymer for use in a known device.” Selecting a particular elastomer ratio for use with drug-loaded stents was seen as a reasonably predictable biomedical application for a known material.
Finally, the Court rejected Ethicon’s argument that the Board erred by discounting its proffered objective indicia of nonobviousness. Ethicon argued that copying, commercial success, industry praise, and unexpected results supported the nonobviousness of the ’844 patent. The Board did not err in its review because Ethicon relied solely on its expert’s conclusory testimony to support its copying allegations.
Judge Newman dissented with the majority’s finding there was motivation to combine the references without hindsight. She argued that the references recite thousands of polymer and copolymer components for stent coating materials, but not the copolymer of the ’844 patent. To the contrary, Tu and Lo did not fill in the gaps in Tuch to render obvious the ’844 patent. She emphasized that “[t]he Board erred in its analysis, collecting elements of the ’844 Patent’s stent from assorted sources, and placing them in the template of the ’844 claim.” Judge Newman also found that the Board erred in declining to consider Ethicon’s evidence of copying, commercial success, and medical acclaim.
The Court’s opinion stresses that in an obviousness analysis, it should consider “whether the improvement is more than the predictable use of prior art elements according to their established functions.” An explicit teaching, suggestion, or motivation in the references is not necessary to support a conclusion of obviousness.