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Combining two embodiments in same prior art patent "does not require a leap of inventiveness"

March 30, 2009
Post by Blog Staff

In a recent decision, the Federal Circuit reversed a district court's denial of judgment as a matter of law of obviousness. A jury held the claim at issue was not obvious, and the district court denied the defendant's post-verdict motion for judgment as a matter of law on the issue.While the Federal Circuit affirmed the district court's construction of two disputed claim terms, according to the Federal Circuit, a single reference disclosing multiple embodiments in sequential drawings that disclosed all the claim limitations rendered the claim in question obvious. More details of Boston Scientific Scimed, Inc. v. Cordis Corp. after the jump.

Boston Scientific owns a patent relating to a drug-eluting expandable stent with a non-thrombogenic surface coating. Claim 8 was the only claim at issue on appeal; it depends from claim 6, which, in turn, depends from claim 1. These claims are reproduced below (disputed terms emphasized):

1. A medical device having at least a portion which is implantable into the body of a patient, wherein at least a part of the device portion is metallic and at least part of the metallic device portion is covered with a coating for release of at least one biologically active material, wherein said coating comprises an undercoat comprising a hydrophobic elastomeric material incorporating an amount of biologically active material therein for timed release therefrom, and wherein said coating further comprises a topcoat which at least partially covers the undercoat, said topcoat comprising a biostable, non-thrombogenic material which provides long term non-thromobogenicity to the device portion during and after release of the biologically active material, and wherein said topcoat is substantially free of an elutable material.
6. The device of claim 1 wherein the medical device is an expandable stent.
8. The device of claim 6 wherein the stent comprises a tubular body having open ends and an open lattice sidewall structure and wherein the coating conforms to said sidewall structure in a manner that preserves said open lattice.

The district court construed "non-thrombogenic" to mean "a material that does not promote thrombosis for a period of time that extends both during and after release of the biologically active material." The Federal Circuit affirmed the district court's construction, noting that the specification and prosecution history did not require comparison of the non-thrombogenic activity of the stent to other stents, particularly bare metal stents as urged by the defendants. The court noted that because no such comparison was required, the district court's construction was in accordance with the specification, prosecution history, as well as the dictionary definition of a related term. The Federal Circuit also affirmed the district court's construction of "long term." The district court held this term to mean "a period of time." The Federal Circuit held this was proper, as the only guideline in the specification as to the relative duration contemplated by this term was two weeks. The court also noted that according to the claim, the "period of time" must be "during and after release of the biologically active material." With these descriptions of the timeframe, the Federal Circuit held the district court's construction was correct.The court next turned to obviousness. The Federal Circuit noted that "when we consider that, even in light of a jury's findings of fact, the references demonstrate an invention to have been obvious, we may reverse its obviousness determination." Here, Cordis asserted claim 8 was obvious in light of a single patent, Wolff. Figures 3B and 4 from Wolff are reproduced below:Wolff figures According to Cordis, "it would have been obvious to combine Wolff’s figure 3B, disclosing a drug-eluting polymer stent with a drug-free coat with the possibility of additional coats, and figure 4, disclosing a metal stent with a drug-eluting polymer coat, to arrive at the invention of claim 8." The court noted that the Wolff reference disclosed a metallic stent with an open lattice structure and a stent including an undercoat and a topcoat where the undercoat contains a drug. Further, the court held Wolff disclosed a topcoat that was drug-free and non-thrombogenic. The court determined that the Wolff reference, in two separate embodiments pictured side by side in the patent, disclosed all of the limitations of claim 8. While Boston Scientific argued Wolff did not recognize the additional benefits of a topcoat that is substantially drug-free, the court held this was irrelevant to the obviousness analysis.The court held that one of ordinary skill in the art would have been motivated to combine the two embodiments in the side by side figures, stating "[c]ombining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness." The court further noted that the evidence of secondary considerations was inadequate to overcome the prima facie showing of obviousness. As a result, the Federal Circuit reversed the district court's denial of judgment as a matter of law on the issue of obviousness.To read the full decision in Boston Scientific Scimed, Inc. v. Cordis Corp., click here.


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