Pointing to the “normal desire” of scientists to improve what is already known as a rationale to combine, the US Court of Appeals for the Federal Circuit affirmed the Patent Trial and Appeal Board’s (PTAB’s) inter partes reexamination decision finding Ethicon’s claims obvious over a combination of three prior art references. In re Ethicon, Inc., Case No. 15-1696 (Fed. Cir., Jan. 3, 2017) (Lourie, J) (Newman, J., dissenting). 

Ethicon’s patents are directed to drug-eluting stents coated with a co-polymer made from two polymers, VDF and HFP, at an 85:15 percent weight ratio. In contrast to polymer-coated stents in the prior art, stents with the claimed co-polymer coating help prevent blood vessels from closing after implantation. 

The PTAB concluded that the claims were obvious over the Tuch, Tu and Lo references, finding that (1) Tuch teaches stents coated with VDF alone, and teaches that coatings with low elasticity cause problems; (2) Tu teaches that VDF:HFP co-polymers have good elasticity, but does not teach the claimed ratio; and (3) Lo teaches that VDF:HFP co-polymers at the claimed 85:15 percent ratio provide good elasticity for non-biomedical, industrial applications. Ethicon appealed. 

The Federal Circuit affirmed, concluding that “the claimed invention is merely the simple substitution of a coating (VDF:HFP) known to be useful in in vivo applications, including stents, in a weight ratio (85:15) known to provide a good balance between strength and elasticity, for the VDF coating disclosed in Tuch.” 

Ethicon argued that there was no motivation to combine the three references, but the Federal Circuit relied on KSR in explaining that a specific teaching, suggestion or motivation to combine was not required. Instead, “[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.” 

The Federal Circuit also rejected Ethicon’s argument that Tuch teaches away from use of non-bioabsorbable (BA) coatings such as VDF:HFP, finding instead that Tuch teaches both BA and non-BA coatings, and that BA is preferred. As the Court explained, there can be no teaching away absent “clear discouragement.” Nor was the Court persuaded by Ethicon’s argument that Tu relates to non-stent devices and thus teaches away from allowing a polymer like VDF:HFP to contact blood. Rather, the Court found that the teachings cited by Ethicon were clearly limited to one specific embodiment, and when read as a whole, Tu’s invention is broadly applicable to biomedical devices that come into contact with blood. 

The Federal Circuit also rejected Ethicon’s argument that Lo concerns very old, non-analogous art that has nothing to do with medical devices. Citing the PTAB’s reliance on Lo’s teachings regarding properties of VDF:HFP co-polymers, the Court found substantial evidence that Lo is “reasonably pertinent” to the problem that the inventors were addressing. The Court further noted that the “mere age” of a reference is not persuasive evidence of non-obviousness absent concrete evidence of a long-felt need or failure of others.

The Federal Circuit gave little weight to Ethicon’s objective indicia of non-obviousness, finding “scant support in the record” and “conclusory” expert testimony concerning copying, commercial success, industry praise and unexpected results. The Court also concluded that Ethicon did not provide substantial evidence showing a nexus between the objective indicia and the VDF:HFP 85:15 coating.

Judge Newman, in dissent, characterized the obviousness analysis as pure hindsight and noted that an invention is not obvious simply because its component parts were “independently known in the prior art.” She concluded that the PTAB erred by “collecting the elements of the . . . Patent’s stent from assorted sources, and placing them in the template of the ’844 claim. The only guide to this reconstruction is the . . . Patent itself.” Judge Newman also noted that “[t]he Tu devices are different products requiring different properties for different purposes.” Indeed, Tu does not even mention stents, and the polymers in Tu must be cured at extremely high temperatures that far exceed the temperature ceiling described in the Ethicon patent.