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In re Ethicon, Inc.

United States Court of Appeals, Federal Circuit

January 3, 2017


          Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in Nos. 95/000, 542, 95/000, 552.

          Joseph Lucci, Baker & Hostetler LLP, Philadelphia, PA, argued for appellant. Also represented by John Frank Murphy, Charlie C. Lyu.

          Farheena Yasmeen Rasheed, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA, argued for intervenor Michelle K. Lee. Also represented by Thomas W. Krause, Scott Weidenfeller.

          Before Newman, Lourie, and Dyk, Circuit Judges.


          Lourie, Circuit Judge

          Ethicon, Inc. ("Ethicon") appeals from the U.S. Patent and Trademark Office ("PTO") Patent Trial and Appeal Board's ("the Board's") decision in a merged inter partes reexamination affirming the examiner's obviousness rejection of claims 1-17 and 19-23 of U.S. Patent 7, 591, 844 ("the '844 patent"). See Boston Sci. SCIMED v. Cordis Corp., No. 2014-008135, 2015 WL 883933 (P.T.A.B. Feb. 27, 2015) ("Decision"). Because the Board did not err in its obviousness conclusion, we affirm.


         Ethicon owns[1] 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. '844 patent col. 1 ll. 21-31, col. 5 ll. 50-57. Angioplasty can be used to alleviate blockages of blood vessels. Id. col. 1 ll. 33-46. However, expansion of the balloon catheter during angioplasty can result in injury to the smooth muscle cells within the vessel wall, which can lead to restenosis, the gradual re-closure of the vessel. Id. col. 1 l. 46-col. 2 l. 45. The '844 patent teaches that stent coatings themselves, and stent coatings delivering drugs locally, may be capable of reducing restenosis. Id. col. 4 ll. 43-54. The '844 patent teaches that previously "[s]tents with coatings made from polyvinylidenefluo-ride [VDF] homopolymers and containing pharmaceutical/therapeutic agents or drugs for release have been suggested." Id. col. 5 ll. 4-6.

         Claim 1 is representative of the challenged claims and reads as follows:

1. A device for intraluminal implantation in a vessel comprising a balloon-expandable stent and a pharmaceutical agent-containing coating, said coating comprising a biocompatible polyfluoro copolymer that comprises about eighty-five weight percent vinylidinefluoride [VDF] copolymerized with about fifteen 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 greater than 60° C. [sic] during the coating process or afterward, thereby providing an adherent coating that remains adhered to the device upon expansion of the balloon-expandable stent.

'844 patent col. 37 l. 59-col. 38 l. 3.

         Ethicon sued Boston Scientific SCIMED ("Boston Scientific") and Abbott Laboratories ("Abbott" and, collectively with Boston Scientific, "Requesters") in the United States District Court for the District of New Jersey on allegations of, inter alia, infringement of the '844 patent. Subsequently, in 2010, the Requesters each filed separate requests for inter partes reexamination of the '844 patent. The PTO merged and granted the requests for inter partes reexamination.

         During the reexamination, Ethicon cancelled claims 18 and 24 by amendment. The examiner rejected remaining claims 1-17 and 19-23 as obvious over, inter alia, U.S. Patent 5, 824, 048 ("Tuch"), U.S. Patent 4, 816, 339 ("Tu"), and U.S. Patent 3, 178, 399 ("Lo"), and relied on a translation of Fr. Patent 2, 785, 812 ("Le Morel") to reject certain dependent claims. The examiner found that the evidence submitted by Ethicon regarding objective indicia of nonobviousness was insufficient to outweigh the conclusion of obviousness. Ethicon appealed to the Board, arguing that the examiner erred in combining the prior art references and by discounting the objective indicia.

         Tuch discloses intravascular stents, including balloon-expandable stents, with a coating on the tissue-contacting surface that includes a polymer and a drug. Tuch col. 2 ll. 35-42, col. 4 ll. 10-13. Tu discloses implantable medical devices such as vascular grafts and heart valve leaflets made from a multi-layered polytetrafluoroeth-ylene/elastomer material. Tu col. 1 ll. 21-32. Tu lists VDF:HFP copolymer first in its list of potential elastomers, id. col. 4 ll. 30-32, and states that the elastomer may contain drugs, e.g., heparin, for release into the surrounding environment, id. col. 9 ll. 65-68. Lo discloses properties of VDF:HFP copolymer at various weight ratios, including 85:15. Lo Fig. 1, col. 9 ll. 15-36. Le Morel discloses stents with a VDF:HFP coating. J.A. 10748-49.

         The Board affirmed the examiner's rejection of claims 1-17 and 19-23 as obvious. The Board began its analysis with Tuch and found that Tuch teaches that the polymer in the coating may be either biostable or bioabsorbable and lists VDF as an example of a suitable biostable polymer. Decision, at *4. The Board also found that Tuch teaches that its list of polymers, which includes "vinyl halide polymers and copolymers, " is not exhaustive and that Tuch's teachings would not have limited a skilled artisan to the explicitly listed polymers or dissuaded a skilled artisan from selecting a VDF copolymer. Id. at *7.

         The Board additionally found that Tuch discloses "a problem with coatings with low elasticity, " id. at *10, and that biocompatibility and elasticity are "useful" characteristics for the polymer in its stent coatings, id. at *9. See also id. at *4-5. The Board found that "[s]ince Tuch teaches a problem with cracking when materials having little elasticity are utilized in the polymer layer, one of ordinary skill in the art would have reasonably sought materials with high elasticity to avoid the problem when the stent is expanded." Id. at *9.

         The Board then analyzed Tu and Lo in light of Tuch's teachings. Tu states that "[i]t is not desired to have the elastomer permeate the poly(tetrafluoroethylene)/elasto-mer layer and migrate into the lumen." Tu col. 8 ll. 40- 43. The Board found that this statement only relates to a particular embodiment and that Tu also teaches that the poly(tetrafluoroethylene)/elastomer layer can be used in medical devices such as heart valve leaflets where the VDF:HFP elastomer would be in contact with blood. Decision, at *5, *8. The Board additionally found that Tu teaches that VDF:HFP copolymer possesses the useful properties of biocompatibility and elasticity taught by Tuch and that it is also useful for coatings containing a therapeutic substance. Id. at *5, *9-10.

         The Board similarly found that Lo teaches that 85:15 VDF:HFP "is advantageous with respect to flexibility, elasticity, extensibility, tensile strength, and reverse elongation." Id. at *10. The Board found that a skilled artisan would have been motivated to use 85:15 VDF:HFP, possessing these advantageous properties, as the polymer in Tuch's stent because "Tuch teaches a problem with coatings with low elasticity." Id. The Board also found that "the skilled worker would have reasonably consulted Lo to determine the optimal concentrations for each component, even if Lo does not teach the use of VDF:HFP for medical implants." Id.

         The Board also considered Ethicon's evidence regarding objective indicia of nonobviousness but found that none of it was entitled to substantial weight. Ethicon alleged copying by the Requesters and pointed to the alleged commercial success of, unexpected results obtained by, and industry praise for certain stents sold by the Requesters to support its argument that the claims would not have been obvious.

          The Board found that Ethicon did not submit factual evidence or analysis to support its copying allegations and thus gave them "little weight." Decision, at *11. The Board similarly found that the evidence submitted did not establish that the alleged commercial success, industry praise, or unexpected results were due to the claimed 85:15 VDF:HFP coating rather than to an unclaimed feature such as the drug or stent design. Id. at *11-14. Regarding unexpected results, the Board also found that Ethicon did not establish that the comparisons relied on were to the closest prior art or provide an expert opinion that the results pointed to would have been unexpected. Id. at *13-14.

         The Board also concluded that under KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), "even if Tuch did not disclose a problem with its polymers, one of ordinary skill in the art would have found it obvious to have employed the known polymers of Tu and Lo for their known and expected properties" and that "the reason to combine [the references] could be provided by the 'normal desire of scientists or artisans to improve upon what is already generally known.'" Decision, at *6 (quoting In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003)).

         Ethicon timely appealed, and the Director of the PTO (the "Director") intervened pursuant to 35 U.S.C. § 143, filing a brief and participating in oral argument. We have jurisdiction pursuant to 28 U.S.C. § 1295(a)(4)(A).


         Our review of a Board decision is limited. In re Baxter Int'l, Inc., 678 F.3d 1357, 1361 (Fed. Cir. 2012). We review the Board's legal determinations de novo, In re Elsner, 381 F.3d 1125, 1127 (Fed. Cir. 2004), but we review the Board's factual findings underlying those determinations for substantial evidence, In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir. 2000). A finding is supported by substantial evidence if a reasonable mind might accept the evidence to support the finding. Consol. Edison Co. of New York v. NLRB, 305 U.S. 197, 229 (1938).

         Obviousness is a question of law, based on underlying factual findings, including what a reference teaches, whether a person of ordinary skill in the art would have been motivated to combine the references, and any relevant objective indicia of nonobviousness. Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034, 1047-48, 1051 (Fed. Cir. 2016) (en banc).

         The Supreme Court has cautioned that the obviousness inquiry must "guard against slipping into use of hindsight and . . . resist the temptation to read into the prior art the teachings of the invention in issue." Graham v. John Deere Co. of Kan. City, 383 U.S. 1, 36 (1966) (internal citations and quotations omitted). The Court has also instructed that "when a patent claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result." KSR, 550 U.S. at 416. Similarly, § 103 likely bars patentability unless "the improvement is more than the predictable use of prior art elements according to their established functions." Id. at 417.

         Generally, a skilled artisan would only have been motivated to combine analogous art. Prior art is analogous where either (1) "the art is from the same field of endeavor, regardless of the problem addressed" or (2) even if the reference is not within the same field of endeavor, "the reference still is reasonably pertinent to the particular problem with which the inventor is involved." In re Clay, 966 F.2d 656, 658-59 (Fed. Cir. 1992) (citation omitted). Whether a reference is analogous art is a question of fact. Id. at 658.

         Ethicon argues that the Board's obviousness rejection impermissibly relies on hindsight and fails to provide any reason why one of ordinary skill in the art would have combined the prior art references to create the claimed invention. Specifically, Ethicon argues that Tuch provides no motivation to select polymers other than those it describes and that neither Tuch nor Tu provide a motivation to select VDF or VDF:HFP as the polymer coating. Additionally, Ethicon faults the Board for not making certain fact findings relating to the motivation to combine references.

         The Director responds that substantial evidence supports the Board's factual findings, and the Board's obviousness conclusion was proper under KSR. The Director contends 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. The Director contends that Ethicon's arguments are contrary to the teachings of the references and not supported by applicable law.

         We agree with the Director that substantial evidence supports the Board's factual findings. KSR directs that an explicit teaching, suggestion, or motivation in the references is not necessary to support a conclusion of obviousness. 550 U.S. at 415-16. The Supreme Court has instructed that "a court must ask whether the improvement is more than the predictable use of prior art elements according to their established ...

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