In Re: Ethicon, Inc.


Docket No. 2015-1696

NEWMAN (D), LOURIE, DYK
January 3, 2017

Brief Summary: The FC panel concluded that the “teaching of all of the required components of the claims” by the cited art “support the Board’s combination” of the same “to address the problem regarding elasticity taught by Tuch” which did not teach away and Ethicon’s objective indicia arguments were insufficient (e.g., it “did not establish that any success, praise or unexpected results were due to the 85:15 VDF:HFP coating”).

Summary: Ethicon appealed from PTAB decision in an inter partes reexamination that claims 1-17 and 19-23 of US 7,591,844 (claims 18 and 24 were cancelled by Ethicon) relating to drug-eluting balloon-expandable stents with a specific coating “that remains adhered to the device upon expansion” (“copolymer…compris[ing] about [85] weight percent vinylidinefluoride [VDF] copolymerized with about [15] weight percent hexafluoropropylene [HFP] and at least one pharmaceutical agent intermixed with said copolymer, wherein said coating has not been subjected to a maximum temperature of greater than 60o C [sic] during the coating process or afterward”) are invalid as obvious over three US patents (“Tuch”, “Tu”, and “Lo”) and one FR patent (“Le Morel”). Ethicon appealed the examiner’s rejection to the Board, “arguing that the examiner erred in combining the prior art references and by discounting the objective indicia.” But the Board affirmed the examiner’s conclusions (e.g., “a skilled artisan would have been motivated to use 85:15 VDF:HFP, possessing the[] advantageous properties [of Lo], as the polymer in Tuch’s stent because ‘Tuch teaches a problem with coatings with low elasticity” and “the ‘normal desire of scientists or artisans to improve upon what is already generally known’”; “Ethicon did not submit factual evidence or analysis to support its copying allegations….”) The FC panel explained that it reviews the Board’s legal determinations de novo (In re Elsner, FC 2004) and the “factual findings underlying those determinations for substantial evidence” (In re Gartside, FC 2000; Consol. Edison, US 1938 (“a reasonable mind might accept” it supports the finding)). It also noted Graham’s “guard against slipping into the use of hindsight” (US 1966), a patentable invention must be “more than the predictable use of prior elements according to their established functions” (KSR, US 2007), and that “a skilled artisan only would have been motivated to combine analogous art” (In re Clay, FC 1992). The FC panel concluded that the “teaching of all of the required components of the claims” by the cited art “support the Board’s combination” of the same “to address the problem regarding elasticity taught by Tuch” which did not teach away (e.g., while “Tuch stats that a ‘bioabsorbable polymer is probably more desirable,’…this statement, absent a clear discouragement from use” is not a teaching away (Tyco, FC 2014; Santarus, FC 2012). It also found no error with the Board’s reliance of Lo as the reference is “reasonably pertinent” (i.e., analogous) and “[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 known polymer for use in a known device” (In re Peterson and KSR). And it found no reversible error in the Board’s rejection of Ethicon’s arguments regarding objective indicia of nonobviousness (e.g., “Ethicon’s expert never even opined that the results pointed to would have been unexpected” and “did not establish that any success, praise or unexpected results were due to the 85:15 VDF:HFP coating”.) Thus, the Board decision was affirmed. Judge Newman’s dissent argued the references, “or any common knowledge or common sense” did not “tecach[] or suggest[] or motivate[] the claimed stent.”

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