author: LOURIE, Circuit Judge. NEWMAN, Circuit Judge,

text:
    IN RE: ETHICON, INC., a Johnson & Johnson Company, Appellant
    2015-1696
    United States Court of Appeals, Federal Circuit.
    Decided: January 3, 2017

      Joseph Lucoi, 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 Weid-ENFELLER.
    Before NEWMAN, LOURIE, and DYK, Circuit Judges.
   Dissenting opinion filed by Circuit Judge NEWMAN.

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.

BACKGROUND,

Ethicon owns the ’844 patent, which relates to intraluminal medical devices for the local delivery of drugs, e.g., drug-elut-ing stents, and methods for maintaining drugs on those devices. ’844 patent col. 111. 21-31, col. 5 11. 50-57. Angioplasty can be used to alleviate blockages of blood vessels. Id. col. 1 11. 33-46. However, expansion of the balloon catheter during angio,-plasty 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. 11. 46-col. 21. 45. The ’844 patent teaches that stent coatings themselves, and stent coatings delivering drugs locally, may be capable of reducing restenosis. Id. col. 4 11. 43-54. The ’844 patent teaches that previously “[s]tents with coatings made from polyvi-nylidenefluoride [VDF] homopolymers and containing pharmaceutical/therapeutic agents or drugs for release have' been suggested.” Id. col. 511. 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 biocompatiblé polyfluoro copolymer ' that comprises about eighty-five weight percent vinylidine-fluoride [VDF] copolymerized' with about fifteen weight percent hexafluo-ropropylene [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. 371. 59-col. 38 1. 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 can-celled 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. Ethi-con 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 11. 35-42, col. 4 11.10-13. Tu discloses implantable medical devices such as vascular grafts and heart valve leaflets made from a multi-layered polytetrafluoroethy-lene/elastomer material. Tu col. 111. 21-32. Tu lists VDF:HFP copolymer first in its list of potential elastomers, id. col, 4 11. 30-32, and states that the elastomer may contain drugs, e.g., heparin, for release into the surrounding environment, id. col. 9 11. 65-68. Lo discloses properties of VDF:HFP copolymer at various weight ratios, including 85:15. Lo Fig. 1, col. 9 11.15-36. 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 biocom-patibility 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 “[sjince 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(tetrafluoroethy-lene)/elastomer layer and migrate into the lumen.” Tu col. 8 11. 40-43. The Board found that this statement only relates to a particular embodiment and that' Tu also teaches that the poly(tetrafluoroethy-lene)/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 biocompati-bility 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 nonob-viousness 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, 127 S.Ct. 1727, 167 L.Ed.2d 705 (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 tide ‘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).

Discussion

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, 59 S.Ct. 206, 83 L.Ed 126 (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, 86 S.Ct. 684, 15 L.Ed.2d 545 (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, 127 S.Ct. 1727. 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, 127 S.Ct. 1727.

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 omit-' ted). 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 KSB. 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, 127 S.Ct. 1727. 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-functions,” id. at 417, 127 S.Ct. 1727, and apply “an expansive and flexible approach” to obviousness, id. at 415, 127 S.Ct. 1727.

Here, the Board made sufficient factual findings under the circumstances to support its obviousness conclusion and those findings are supported by substantial evidence. Tuch teaches that the polymer must be “biocompatible,” Tuch col. 5 11. 14-16. Tuch explains that coating overlayers “made with materials which have little elasticity ... can sustain significant cracking during [stent] deformation” and that such cracking can result in more rapid elution of drugs. Id. col. 7 11. 11-15. Tuch teaches that “inclusion of a polymer in intimate contact with a drug on' the stent allows the drug to be rétained on the stent in a resilient[, ie., elastic,] matrix during expansion of the stent and also slows the administration of drug following implantation.” Id. col. 2 11. 42-46. Those teachings constitute substantial evidence supporting the Board’s findings that Tuch teaches that elasticity and biocompatibility are useful polymer characteristics and that coatings with low elasticity are problematic.

The Board relied on Tu and Lo' for teachings regarding an 85:15 weight ratio of VDF:HFP. Tu teaches that the elastomer “promotes the, elasticity [and] strength” of the medical devices, Tu col. 3 11. 61-64, and lists VDF:HFP first in its list of preferred elastomers, id. at col. 411. 30-32. Lo similarly teaches VDF:HFP copolymers with “varying degrees of flexibility, elasticity and extensibility,” Lo col. 2 11. 33-48, and that a weight ratio of 85:15 VDF:HFP achieves the optimal combination of tensile strength and reversible elongation, id. Fig. 1, col 9 11. 15-36. These teachings of all of the required components of the claims support the Board’s combination of the three references tó address the problem regarding elasticity taught by Tuch.

Ethicon also challenges certain factual findings .made by the Board regarding the references. First, Ethicon contends that Tuch never suggests that the elasticity of the polymer itself is an important characteristic and asserts that it teaches away from using non-bioabsorbable coatings such as VDF:HFP by recommending bioabsorbable polymers. Second, Ethicon asserts that Tu is directed to medical devices other than stents and teaches away from allowing an elastomeric polymer such as VDF:HFP to be in contact with blood. Third, Ethicon argues that Lo is decades old, nonanalogous art that provides no motivation to combine its teachings with medical devices. Ethicon asserts that Lo is directed to coatings for harsh, industrial applications, not implantable medical devices.

The Director responds that the challenged factual findings are supported by substantial evidence. First, the Director contends that Ethicon’s arguments are contrary to the teachings of Tuch. Second, the Director asserts that Ethicon ignores the similar properties shared by coatings suitable for the devices disclosed by Tu and the ’844 patent and ignores embodiments in Tu that teach that the blood contacting layer can comprise VDF:HFP. Third, the Director contends that Ethicon ignores that Lo discloses properties of VDF:HFP that would have been relevant to a skilled artisan considering a coating on a stent and that Lo’s age is irrelevant absent a showing of long-felt need or the failure of others. .

We agree with the Director .that substantial evidence supports the- challenged findings. First, as discussed above, substantial evidence supports the Board’s findings that Tuch teaches that elasticity is a useful polymer characteristic and that coatings with low elasticity are problematic. Additionally, Tuch teaches that its “polymer may be either a biostable or bioabsorbable polymer,” Tuch col. 5 11. 16-17 (emphasis added), and lists VDF as an example of a suitable biostable polymer, id. col. 5 11. 33-53. Although Tuch states that a “bioabsorbable polymer is probably more desirable,” id, col. 5 11, 19, this statement, absent clear discouragement from use, does not compel a finding that Tuch teaches away from using VDF:HFP as a stent coating. See Tyco Healthcare Grp. LP v. Ethicon Endo-Surgery, Inc., 774 F.3d 968, 977 (Fed. Cir. 2014) (‘Yet simply because the curved blade configurations are not preferred embodiments does not result in the Davison patent teaching away from, use of a curved blade, ‘absent clear discouragement of that combination.’ ” (quoting Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344, 1356 (Fed. Cir. 2012))); see also In re Applied Materials, Inc., 692 F.3d 1289, 1298 (Fed. Cir. 2012) (“A reference must be considered for everything that it teaches, not simply the described invention or a preferred embodiment.”).

Second, although Tu states that “[i]t is not desired to have the elastomer permeate the poly(tetrafluoroethy-lene)/elastomer layer and migrate into the lumen,” Tu col. 8 11. 40-43, substantial evidence supports the Board’s finding limiting this statement to a particular embodiment and its finding that Tu teaches that the elastomer can be in contact with blood. Tu teaches that its invention has a “very broad application in biomedical devices, such as ,, heart valve leaflets,” id. col. 2 11. 36-40, and an alternative embodiment where the “combination of layers provides for better hydrophilicity due to the elas-tomer in the luminal layer,” id. col. 9 11. 56-60. See also id. col. 1 11. 27-32, col. 9 11. 65-68.

Third, we can discern no error in the Board’s reliance on Lo. The ’844 patent states that “[i]t would be advantageous to develop coatings for implantable medical devices ... that possess physical and mechanical properties effective for use in such devices_” ’844 patent col. 5 11. Ills. The Board relied on Lo for “teaching the properties of VDF:HFP” at different ratios of copolymer. Decision, at *10. Substantial evidence supports finding that Lo’s teachings are at least “reasonably pertinent to the particular problem with which -the inventor is involved,” In re Clay, 966 F.2d at 659, and that a skilled artisan would have combined those teachings with Tuch and Tu. The 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. See In re Peterson, 315 F.3d at 1330; see also KSR, 550 U,S. at 421, 127 S.Ct. 1727 (“A person of ordinary skill is also a person of ordinary creativity, not an automaton.”).

Furthermore, the age of Lo does not undermine the Board’s reliance on it for teaching the ratio of the copolymer components. “The mere age of the references is not persuasive of the unobviousness of the combination of their teachings, absent evidence that, notwithstanding knowledge of the references, the art tried and failed to solve the problem.” In re Wright, 569 F.2d 1124, 1127 (CCPA 1977) (citation omitted). Ethicon presented no evidence of a long-felt need or the failure of others.

Finally, Ethicon argues that the Board erred by discounting its proffered objective indicia of nonobviousness. Ethicon asserts that copying, commercial success, industry praise, and unexpected results support the nonobviousness of the ’844 patent.

The Director responds that Ethicon’s evidence regarding objective indicia is insufficient to overcome the prima facie case of obviousness. The Director contends that Ethicon’s arguments have scant support in the record and that the Board’s factual findings are supported by substantial evidence.

We agree with the Director that the Board properly weighed Ethicon’s evidence of objective indicia. Ethicon relied solely on its expert’s conclusory testimony to support its copying allegations. J.A. 3763. Regarding unexpected results, Ethi-con’s expert never even opined that the results pointed to would have been unexpected to a person of ordinary skill in the art. J.A. 3764. Moreover, the Board’s finding that the evidence relied on by Ethicon to support its claims of commercial success, industry praise, and unexpected results did not establish that any success, praise or unexpected results were due to the 85:15 VDF:HFP coating, rather than to an unclaimed feature such as the drug or stent design, is supported by substantial evidence. See J.A. 3763-64; J.A. 4200-05. We can discern no reversible error in the Board’s findings.

CONCLUSION

We have considered all of Ethicon’s remaining arguments, but conclude that they are without merit. The Board’s decision was supported by substantial evidence and was not erroneous as a matter of law. For the reasons set forth above, we affirm the Board’s decision.

AFFIRMED

NEWMAN, Circuit Judge,

dissenting.

United States Patent No. 7,591,844 (“the ’844 Patent”) is for a balloon-expandable vascular stent having a drug-eluting coating of a copolymer of vinylidene fluoride and hexafluoropropylene in about 85/15 weight percent monomer ratio. Novelty is not disputed. On this inter partes reexamination requested by Boston Scientific Scimed and Abbott Laboratories, the PTAB held that the prior art rendered obvious the claimed vascular stent. I cannot agree, for no reference or combination of references, or common knowledge or common sense, teaches or suggests or motivates the claimed stent.

Claim 1 was accepted as representative:

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 vinylidine fluoride [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 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. 37,1. 59-col. 38,1. 3. It was generally agreed that the novelty and advantages are due to the specific copolymer coating material for the balloon-expandable stent.

The references cited by the PTO Board recite thousands of polymer and copolymer components for stent coating materials, but not the copolymer of the ’844 Patent, although this copolymer was known for other uses. There is no hint, no suggestion, of its use as a drug-eluting coating in a vascular stent, nor were its advantages foreseen. Nonetheless the Board deemed it obvious, and this court agrees. I respectfully dissent.

Errors of fact, analysis, and law

The Board relied on three groups of references, and the court has followed this pattern on appellate review. The Board’s first set of references was cited to show that polymer-coated vascular stents were known; the second set was “consulted” to show various polymers used in medical devices and structures unrelated to vascular stents; and the third set was cited to show that the ’844 Patent’s copolymer was known for unrelated uses such as clothing, boots, helmets, electrical tapes, and linings for tanks and storage vessels. No reference or combination of references teaches or suggests or motivates- or otherwise renders obvious the ’844 Patent’s vascular stent.

The coated vascular stent references (Tuch)

The Board provided a foundation for its analysis with the first set of references, focusing on the Tuch patent, which shows polymer-coated drug-eluting vascular stents. Such vascular stents were known, and the ’844 Patent so states. U.S. Patent No. 5,824,048 (the Tuch reference) names hundreds of monomers encompassing thousands of polymers and copolymers, and states that they may all be usable for vascular stents in various conditions. However, the specific ’844 Patent’s copolymer is not mentioned, and although the list includes one of the ’844 Patent’s comonom-ers, vinylidene fluoride, the other known monomer, hexafluoropropylene, is not mentioned. This silence cannot render obvious the omitted copolymer, for nothing in Tuch suggests selection of this omitted copolymer from the thousands of polymeric and other potential stent materials listed by Tuch:

The polymer may be either a biostable or a bioabsorbable polymer depending on the desired rate of release or the desired degree of polymer stability, but a bioabsorbable polymer is probably more-desirable since, unlike a-biostable polymer, it will not be present long after implantation to cause any adverse, chronic local response. Bioabsorbable polymer's that could be used include poly(L-lactic acid), polycaprolactone, poly(lactide-eoglycolide), poly(hydroxy-butyrate), poly(hydroxybutyrate-co-val-erate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(D,L-lactic acid), poly(glycolic acid-co-trimethylene carbonate), polyphos-phoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, poly(trimethylene carbonate), polyfimi-nocarbonate), copoly(ether-esters) (e.g. PEO/PLA), polyalkylene oxalates, poly-phosphazenes and biomolecules such as fibrin, fibrinogen, cellulose, starch, collagen and hyaluronic acid. Also, biostable polymers with a relatively low chronic tissue response such as polyurethanes, silicones, and polyesters could be used and other polymers could also be used if they can be dissolved and cured or polymerized on the stent such as polyole-fins, polyisobutylene and ethylene-al-phaolefin copolymers; acrylic polymers and copolymers, vinyl halide: polymers and copolymers, such as polyvinyl chloride; polyvinyl ethers, such as polyvinyl methyl ether; polyvinylidene halides, such as polyvinylidene fluoride and poly-vinylidene chloride; polyacrylonitrile, polyvinyl ketones; polyvinyl aromatics, such as polystyrene, polyvinyl esters, such as polyvinyl acetate; copolymers of vinyl monomers with each other and olefins, such as ethylene-methyl metha-crylate copolymers, acrylonitrile-styrene copolymers, ABS resins, and ethylene-vinyl acetate copolymers; polyamides, such as Nylon 66,and polycaprolactam; alkyd resins; polycarbonates; polyoxy-methylenes; polyimides; polyethers; epoxy resins; polyurethanes; rayon; rayon-triacetate; cellulose, cellulose acetate, cellulose butyrate; cellulose acetate bu-tyrate; cellophane; cellulose nitrate; cellulose propionate; cellulose ethers; and carboxymethyl cellulose,

Tuch, col 6,11.16-63.

The Tuch encyclopedia cannot be taken to teach or suggest or motivate that the unmentioned copolymer of the ’844 Patent should be identified and used in a vascular stent. “[T]he breadth of these choices and the numerous combinations indicate that these disclosures would not have rendered the claimed invention obvious to try.” Leo Pharma. Prods., Ltd. v. Rea, 726 F.3d 1346, 1356-67 (Fed. Cir. 2013). Nothing in the Tuch reference, or any other reference, suggests use of the ’844. Patent’s copolymer for vascular stents, even for experimentation:

[A]n invention would not have been obvious to try when the inventor would have had to try all possibilities in a field unreduced by direction of the prior art.

Bayer Schering Pharma AG v. Barr Labs., Inc., 576 F.3d 1341, 1347 (Fed. Cir. 2009).

However, the Board deemed it irrelevant that the ’844 Patent’s copolymer was omitted by Tuch, and erroneously found that this copolymer was “a prior art element used for its established function.” The Board statéd:

It is unnecessary that Tuch disclose any shortcomings in its list of polymers for the ordinary skilled worker to have found it obvious to have employed an alternative polymer for its coating since it is obvious to use a prior art element for its established function.

Board Op. at 10-11. This finding has no support, for Tuch does not lead to the undisclosed copolymer of the ’844 Patent or any established function in the drug-eluting vascular stents to which Tuch is directed. The “established function” of this copolymer is shown in the prior art to be quite different, as in the cited Lo reference, discussed post.

Tuch does not provide substantial evidence of the ’844 Patent’s copolymer as a stent material or possible stent material. The “substantial evidence” standard of judicial review of Board findings “involves examination of the record as a whole, taking into account evidence that both justifies and detracts from an agency’s decision.” In re Gartside, 203 F.3d 1305, 1312 (Fed. Cir. 2000). The Tuch reference as a whole, with its massive listing of thousands of polymers and copolymers but not the ’844 copolymer, does not provide substantial evidence of any suggestion or any reason to select the ’844 Patent’s copolymer for use in drug-eluting vascular stents.

“Consultation” of the Tu reference

Perhaps recognizing the inadequacy of Tuch, the Board “consulted” the Tu et al. reference, U.S. Patent No. 4,816,339. Tu describes multilayered “suturable vascular implants” having “improved luminal hydro-phobicity, compliance, strength and elasticity.” Tu, col. 2,11. 7-11. The first Tu layer is made of poly(tetrafluoroethylene), the second layer is “a mixture of poly(tetraf-luoroethylene) and elastomer,” and an optional third layer is made of “elastomer.” Tu, col. 3, 11. 48-65. Tu states that the elastomer may be selected from a diverse group of polymers and copolymers, including the ’844 Patent’s copolymer components:

The elastomer is preferably selected from the group consisting of polyvinyli-dene fluoride co-hexafluoropropylene, poly(tetrafluoroethylene-coperfluoro(me-thylvinylether)), poly(tetrafluoroethy-lene-co-propylene), poly(vinylidene-co-chlorotrifluoroethylene), silicones, fluo-rosilicones, fluoroalkoxy phosphazenes, segmented copolyester ether, styrene butadiene block copolymers, polyeth-ers[,] acrylonitrile butadienes, isoprenes, polyurethanes, and mixtures thereof.

Tu, col. 4, 11. 30-39. Tu’s preferred elas-tomers are a copolymer of tetrafluoroethy-lene and propylene, and silicone. Tu, col. 4, 11. 61-66; col. 5, 1. 7. The Board stated:

The reason to consult Tu is because Tuch’s list of polymers is clearly not exhaustive in viéw of Tuch’s description of broad- classes of polymers, such as vinyl halide polymers and copolymers, and polyvinylidene halides. Tuch 6. Tuch also uses the transitional phrase “such as” in prefacing the list of biostable polymers and in reciting specific examples of the broader classes, indicating that Tuch did not confine the skilled worker to the explicit list, but contemplated polymers outside of it.

Board Op. at 7. Tu does not state that its multilayered suturable implants are useful in vascular stents, or suggest selection- of any of its materials for this purpose. Tu cannot be read as teaching that its materials enlarge the listing of suitable stent polymers in Tuch, to place the Tu materials in the Tuch disclosure. The Tu devices are different products requiring different properties for different purposes.

The Board states that it consulted Tu “for teaching of a medical device comprising VDF:HFP.” Board Op. at 3. Tu does not mention vascular stents, and suggests no composition or properties for such use. It is apparent that the Tu multilayered structure differs from a vascular stent, and the Board did not find otherwise. Also, as an additional difference Tu requires “curing” at a temperature of about 150° C to about 350° C, Tu, col. 7,1L 66-68; col. 9,11. 12-14, excluding the ’844 Patent product’s temperature ceiling of “60° C during the coating process or afterward.” ’844 Patent, col. 37,1. 66-col. 38,1.1.

The Board states that'Tu shows that the VDF:HFP copolymer “has the properties described in Tuch as useful for its stent coating.” Board Op at. 14. The Tuch properties are not the properties of Tu’s multi-layered suturable vascular implants. Tu states that its implants have elasticity “because of the arrangement of layers”:

The biologically compatible material of the present invention has excellent compliance, strength and elasticity because of the arrangement of layers of poly(tet-raflúoroethylene), poly(tetrafluoroethy-lene)/elastomer, elastomer and fibrous elastomers.

Tu, col. 2, 11. 31-35. This is not a teaching or suggestion of the ’844 Patent’s copolymer-coated drug-eluting stent.

Ignoring all of these discrepancies, the Board ruled that since a VDF:HFP -copo-lymer with undefined monomer ratio is usable as Tu’s optional third elastomer layer, it, would have been obvious to use it in the Tuch stent. Neither Tuch nor Tu so suggests. The Board’s ruling illustrates the “insidious” exereise of decisional hindsight, whereby that which the inventor taught is used by the decision-maker to reconstruct the invention. This fallacy has long been rejected:

To imbue one of ordinary skill in the art with knowledge of the invention in suit, when no prior art reference or references of record convey or suggest that knowledge, is to fall victim to the insidious effect of a hindsight syndrome wherein that which only the inventor taught is used against its teacher.

W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540, 1553 (Fed. Cir. 1983).

Tu does not provide substantial evidence for selecting the ’844 Patent’s copolymer in a vascular stent. The Board acknowledged that neither Tuch nor Tu suggests the 85/15 monomer ratio of vinylidene fluoride and hexafluoropropylene. The ’844 Patent demonstrates differences in the properties of various monomer ratios, in that the 85/15 copolymers are “semicrystalline,” and that copolymers with a 60.6/39.4 ratio are “marketed as elastomers.” ’844 Patent, col. 20, 11. 22-27. This evidence weighs against reliance on the Tu reference to teach the 85/15 copolymer for properties suitable for a vascular stent.

The Supreme Court guides that “it can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007). Tu does not fill the gaps in Tuch to render obvious the selection of this specific copolymer and ratio for use in the Tuch stent, for Tu provides no reason for a person of ordinary skill to select the 85/15 copolymer for use in Tuch.

The Lo reference

The Board’s third set of references, represented byLo, does not shift this balance. The Board cited U.S. Patent No. 3,178,399 (the Lo reference), a 50-year-old patent that shows that the ’844 copolymer in 85/15 ratio was a known product with known uses. Copolymers of vinylidene fluoride and hexafluoropropylene having comonomer ratios similar to the ’844 Patent’s 85/15 ratio are described in the Lo reference as having a

unique combination of tensile strength and reversible elongation properties and are especially suitable as durable, flexible coatings for application to various fabric surfaces. These surfaces may, in a preferred form of application, take the form of protective clothing (for example, as suits, boots, gloves, helmets and other wearing apparel) and other articles of manufacture which are comprised of exposed surfaces which may be subjected to bending, folding, or other forms of distortion in the course of performing their function under special environmental conditions. They may also be used in film form (either oriented or unoriented) e.g. in electrical tapes, magnetic recording tapes, etc., and as protective coatings on tanks, storage vessels and the like.

Lo, col. 10, 11. 27-39. None of these uses has any relation to a vascular stent or any biological application. However, from Lo’s uses as boot and helmet coatings and electrical tapes, the Board stated that “Lo describes copolymers of vinylidene fluoride (VDF) and hexafluoropropylene (HFP) which have flexibility, elasticity, and extensibility,” Board Op. at 5, and from this selection out of context the Board extracted obviousness of use in a drug-eluting vascular stent. Lo’s range of uses of this known copolymer, undifferentiated as to monomer ratio and copolymer properties, does not fill the gaps in Tuch and Tu to .suggest use for a drug-eluting vascular stent.

The Board erred in its analysis, collecting the elements of the ’844 Patent’s stent from assorted sources, and placing them in the template of the ’844 claim. The only-guide to this reconstruction is the ’844 Patent itself. See Interconnect Planning Corp. v. Fell, 774 F.2d 1132, 1138 (Fed. Cir. 1985) (“The invention-must be viewed not with the blueprint drawn by the inventor, but in the state of the art that existed at the time.”). The Court has reinforced that “a patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was independently known in the prior art.” KSR Int’l Co., 550 U.S. at 418-19, 127 S.Ct. 1727. Neither the record nor the law supports the Board’s conclusion that a person of ordinary skill would be motivated to select this Lo copolymer for use in a vascular stent.

The objective evidence

The “secondary considerations” are part of the obviousness determination. See Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966) (“Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented.”); W.L. Gore, 721 F.2d at 1555 (objective evidence “should when present always be considered as an integral part of the analysis.”).

The Board erred in declining to consider the evidence of copying, commercial success, and medical acclaim. Such evidence “may often be the most probative and cogent evidence in the record.” Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir. 1983), for the objective evidence reflects the “temporal and technical perspective” of the invention. Mintz v. Dietz & Watson, Inc., 679 F.3d 1372, 1378 (Fed. Cir. 2012).

This evidence must be considered along with the entirety of the evidence. Stratoflex, 713 F.2d at 1538-39 (objective evidence “is to be considered as part of all the evidence, not just when the decision-maker remains in doubt after reviewing the art.”); In re Mageli, 470 F.2d 1380, 1383 (C.C.P.A. 1973) (“[Evidence bearing on the facts is never of ‘no moment,’ is always to be considered, and accorded whatever weight it may have.”). The response of the marketplace, and copying by competitors, may' evidence the improved technology and beneficial properties of an invention. Ethicon’s expert Dr. Mikos described the advantages of the ’844 Patent’s stent over the available drüg-eluting stents, and the apparently undisputed copying by the competitors who brought this inter partes reexamination. Mikos Decl. at 38-39. Dr. Mikos testified:

Data on file at Abbott Vascular and relied upon by Abbott in its FDA submissions shows that the PVDF-HFP coated Xience V stent is more thrombor-esistant (i.e., shows greater tendency to reduce thrombus formation) than other drug-eluting stent coatings.

Mikos Decl. at 39. He stated, “numerous clinicians have also emphasized that the. PVDF-HFP polymer used in the Xience V stent shows unexpectedly less inflammation.” Id.

The Board declined to consider the evidence of superior properties and commercial success, stating:

This evidence.is not persuasive since it does not establish that the reduction in inflammation observed with Xience V is in comparison with the closest prior art as required under Baxter, 952 F.2d at 392. Rather, it appears the news articles are reporting that Xience’s polymer is less inflammatory than the polymers on existing stents.

Board Op. at 14.

The Board did not identify what it deemed to be an acceptable prior art comparison, except to state that “Patent Owner has not provided sufficient testimony that this reduced inflammation would have been unexpected by one of ordinary skill in the art in comparison to the polymers described in Tuch, for example, which teaches stents with polymer coatings, including a homopolymer of VDF (Tuch6).” Board Op. at 14. The Board, did not mention the comparative data in the ’844 Patent, which compared the 85/15 copolymer with stents coated with the polyvinylidene .fluoride (VDF) homopolymer. ’844 Patent, col. 19, 11. 22-48. The data in the specification showed that the polyvinylidene fluoride homopolymer “adhered poorly to the stent and flaked off, indicating they were too brittle” when dried at the low temperatures required by the ’844 Patent. ’844. Patent, col. 19,11. 36—41.

The ’844 Patent also included comparative data with copolymers of vinylidene fluoride and hexafluoropropylene in 92/8 and 91/9 weight percent ratios, and showed the superior results obtained with the 85/15 ratio. ’844 Patent, col. 19, 11. 24-28, 36-41. The ’844 Patent also compared the 85/15 copolymer with copolymers having a 60(6/39.4 ratio, which were “marketed, as elastomers.” ’844 Patent, col. 20, 11. 22-24. Those copolymers, when mixed with rapa-mycin and dried at the claimed temperature, produced “a white film, indicating phase separation of the drug and the polymer.” ’844 Patent, col. 20, 11. 55-60. In contrast, with the 85/15 copolymer “a clear coating, indicating a solid solution of the drug in the polymer, is obtained.” ’844 Patent, col. 20, 11. 53-55. Additional comparative data in the ’844 Patent showed differences in the fraction of drug released over time between the claimed 85/15 copo-lymer and the 60.6/39.4 copolymer of vinyl-idene fluoride and hexafluoropropylene without a topcoat. ’844 Patent, Figs. 3 and 5; col. 21,11. 9-24.

These comparisons are evidence of unpredicted results. “Consistent with the rule that all evidence of nonobviousness must. be considered when assessing patentability, the PTO must consider comparative data in the specification in determining whether the claimed invention provides unexpected results:” In re Soni, 54 F.3d 746, 750 (Fed. Cir. 1995). The Board’s refusal to consider this evidence, instead criticizing the “absence” of comparisons with some undefined prior art, is untenable.

Summary

The references cited by the Board provide no teaching or suggestion or motivation to select the specific copolymer and ratio of the claimed ’844 Patent’s vascular stent, and no basis for expecting that this composition would produce the advantageous properties that are obtained. The Tuch list of stent materials does not lead to selecting the omitted copolymer, of 85% vinylidene fluoride and 15% hexafluoropro-pylene. The Tu multi-layered fabric for medical grafts does not fill this gap in Tuch. And Lo, if anything, leads away from the ’844 Patent, for the Lo products aré not analogous to vascular stents. No combination of references suggests utilization of the ’844 Patent’s copolymer in drug-eluting vascular stents.

Substantial evidence does not support the Board’s findings and conclusion that a person of ordinary skill in the field of this invention would obviously, select the ’844 Patent’s copolymer from its omission in Tuch, from the multilayered fabrics of Tu, and the non-analogous uses in Lo. From the court’s contrary ruling, I respectfully dissent.

      . During the pendency of this appeal, Cordis Corporation assigned the '844 patent to Ethi-con. For simplicity, we refer to the owner of the '844 patent throughout as Ethicon.

      . Boston Scientific Scimed v. Cordis Corp., No. 2014-008135, 2015 WL 883933 (P.T.A.B. Feb. 27, 2015) ("Board Op.’’). The successful re-questers withdrew from this appeal, and the PTO Director has intervened to defend the Board's decision, with the filing of briefs and participation in oral argument.


source: Caselaw Access Project

author: MOORE, Circuit Judge. NEWMAN, Circuit Judge,

license: Public Domain

text:
    IN RE: Marcel VAN OS, Freddy Allen Anzures, Scott Forstall, Greg Christie, Imran Chaudhri, Appellants
    2015-1975
    United States Court of Appeals, Federal Circuit.
    Decided: January 3, 2017
    E. Joshua Rosenkeanz, Orrick, Herring-ton & Sutcliffe LLP, New York,' NY, argued for appellants. Also represented by Christopher J. Cariello; Mark S. Davies, Washington, DC; Brian B. Ho, Peter J. Yim, Morrison & Foerster LLP, San Francisco, CA.
    Brian Racilla, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA, argued for appellee Michelle K. Lee. Also represented by ThoMAS W. Krause, Philip J. Warrick.
    Before NEWMAN, MOORE, and WALLACH, Circuit Judges.
   Opinion concurring in part and dissenting in part filed by Circuit Judge NEWMAN.

MOORE, Circuit Judge.

Appellants Marcel Van Os and other inventors at Apple Inc. (collectively, “Van Os”) appeal from a decision of the Patent Trial and Appeal Board (“Board”) affirming the examiner’s rejection of claims 38-41 of U.S. Patent Application No. 12/364,-470 (“the ’470 application”). For the reasons discussed below, we vacate and remand.

BACKGROUND

The ’470 application is directed to a touchscreen interface in a portable electronic device that allows a user to rearrange icons. Claims 38 and 40, the only independent claims at issue, both recite the initiation of an “interface reconfiguration mode” to permit icon rearrangement. Claim 38 distinguishes among a “first user touch” to open an application, a longer “second user touch” to initiate the interface reconfiguration mode, and a “subsequent user movement” to move an icon. Claim 40 does not recite a touch to open an application, but recites that its “first user touch of at least an established duration” initiates the interface reconfiguration mode and allows movement of an icon “in the absence of a further user input.”

The Board reversed the examiner’s rejection of twenty-nine claims but affirmed that claims 38-41 would have been obvious over U.S. Patent No. 7,231,229 (“Hawkins”) and U.S. Pub. No. 02/0191059 (“Gillespie”). Hawkins discloses a personal communication device with a touch-sensitive screen. It teaches that an “Edit Favorites Button” can be selected from a menu or keyboard command for “performing button 701 configuration and/or editing,” and that “a - user can rearrange buttons 701 by dragging button 701 from one location to another.... ” Gillespie discloses an interface on a computer touch pad with an unactivated and activated state. It discloses that in the activated state, icons are functional and can be removed or rearranged. It teaches that an individual icon could be “activated” by various means, such as touching an icon with multiple fingers or with rapid double taps, hovering the finger over an icon without touching the touch screen, or holding the finger on an icon for a sustained duration, whereas “single taps near an icon could be interpreted as normal mouse clicks.”

The examiner found Hawkins discloses each limitation of claim 38, but “does not explicitly disclose that , the interface reconfiguration mode is initiated by a user touch of a longer duration than a user touch of a first duration used to initiate, an application corresponding to an icon.” J.A. 2063-64. To satisfy this limitation, the examiner relied. on Gillespie’s disclosure of a sustained touch and reasoned adding this feature to Hawkins “would be an intuitive way for users of Hawkins’ device to enter into the editing mode.” J.A. 2064. He found claim 40 to be “substantially the same” and rejected it on the same basis. Id.

The Board incorporated the examiner’s analysis and concluded the examiner did not err in holding that claims 38 and 40, and dependent claims 39 and 41, would have been obvious over a combination of Hawkins and Gillespie. Van Os timely appealed. We have jurisdiction under 28 U.S.C. § 1295(a)(4)(A).

Disoussion

We review the Board’s factual determinations' for substantial evidence and its legal determinations de novo. Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015). Obviousness is a question of law based on subsidiary findings of fact. Id. Whether a person of ordinary skill in the art would have been motivated to modify or combine prior art is a question of fact. Id.

The Board’s conclusion that claims 38-41 of the ’470 application would have been obvious hinges on its finding that a person of .ordinary skill in the art would have been motivated to modify Hawkins’ initiation of an editing mode via menu selection or keyboard command with Gillespie’s disclosure of a sustained touch, “holding the finger steady over an icon for a given duration” to “activate” an icon. Specifically, the Board found, without further discussion, that the combination of Gillespie with Hawkins would have been “intuitive.”

In KSR, the Supreme Court criticized “[r]igid preventative rules that deny fact-finders recourse to common sense” when determining whether there would have been a motivation to combine prior art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 127 S.Ct. 1727, 167 L.Ed.2d 705 (2007). The proper approach, as explained in KSR, credits the common sense and creativity of a skilled artisan to assess whether there would have been a motivation to combine elements from prior art references in the manner claimed. Id. at 418-21, 127 S.Ct. 1727. But the flexibility afforded by KSR did not extinguish the factfinder’s obligation to provide reasoned analysis. Instead, KSR specifically instructs that when determining whether there would have been a motivation to combine, the “analysis should be made explicit.” Id. at 418, 127 S.Ct. 1727.

Since KSR, we have repeatedly explained that obviousness findings “grounded in ‘common sense’ must contain explicit and clear reasoning providing some rational underpinning why common sense compels a finding of obviousness.” Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 (Fed. Cir. 2013) (citation omitted); see also Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362 (Fed. Cir. 2016) (“[References to ‘common sense’ ... cannot be used as a wholesale substitute for reasoned analysis and evidentiary support....”); Randall Mfg. v. Rea, 733 F.3d 1355, 1362 (Fed. Cir. 2013) (“In recognizing, the role of common knowledge and common sense, we have emphasized the importance of a factual foundation to support a party’s claim about what one of ordinary skill in the relevant art would have known.”); Mintz v. Dietz & Watson, 679 F.3d 1372, 1377 (Fed. Cir. 2012) (“The mere recitation of the words ‘common sense’ without any support adds nothing to the obviousness question.”); Perfect Web Techs. Inc. v. InfoUSA Inc., 587 F.3d 1324, 1330 (Fed. Cir. 2009) (“[T]o invoke ‘common sense’ or any other basis for extrapolating from prior art to a conclusion of obviousness, [the factfinder] must articulate its reasoning with sufficient clarity for review.”). Even before KSR, we explained that while the Board may rely on common sense, it must “exr plain why ‘common sense’ of an ordinary artisan seeking to solve the problem at hand would have led him to combine the references.” DyStar Textilfarben GmbH & Co. v. C.H. Patrick Co., 464 F.3d 1356, 1366-67 (Fed. Cir. 2006).

Absent some articulated rationale, a finding that a combination of prior art would have been “common sense” or “intuitive” is no different than merely stating the combination “would have been obvious.” Such a conclusory assertion with no explanation is inadequate to support a finding that there would have been a motivation to combine. This type of finding, without more, tracks the ex post reasoning KSR warned of and fails to identify any actual reason why a skilled artisan would have combined the elements in the manner claimed. See 550 U.S. at 418, 421, 127 S.Ct. 1727.

Here, neither the Board nor the examiner provided any reasoning or analysis to support finding a motivation to add Gillespie’s disclosure to Hawkins beyond stating it would have been an “intuitive way5’ to initiate Hawkins’ editing mode. The Board did not explain why modifying Hawkins with the specific disclosure in Gillespie would have been “intuitive” or otherwise identify a motivation to combine. “The agency tribunal must make findings of relevant facts, and present its reasoning in sufficient detail that the court may conduct meaningful review of the agency action.” In re Lee, 277 F.3d 1338, 1346 (Fed. Cir. 2002) (vacating the Board’s obviousness determination and remanding for the Board to “set forth the findings and explanations needed for ‘reasoned decisionmak-ing’ ”); see also Power Integrations, Inc. v. Lee, 797 F.3d 1318, 1327 (Fed. Cir. 2015) (vacating the Board’s anticipation determination and instructing the Board on remand to “set[ ] out its reasoning in sufficient detail to permit meaningful appellate review”); In re NuVasive, 842 F.3d 1376, 1384 (Fed. Cir. 2016) (vacating the Board’s decision and remanding “for additional explanation of the PTAB’s -findings”). As in In re Lee, Power Integrations, and NuVasive, when the Board’s action is “potentially lawful but insufficiently or inappropriately explained,” we have consistently vacated and remanded for further proceedings. See In re Lee, 277 F.3d at 1346 (internal quotation marks and citations omitted). For these reasons, the Board’s holding that claims 38-41 of the ’470 application would have been obvious is vacated and remanded.

VACATED AND REMANDED

Costs

Costs to Appellants.

NEWMAN, Circuit Judge,

concurring in part, dissenting in part.

I agree that the bare recitation by the Board and examiner that it would have been “intuitive” to combine the disclosures of the Gillespie and Hawkins references is inadequate to support a ruling of obviousness. I write separately because remand is not the appropriate remedy in examination appeals in which the PTO has not carried its burden of establishing unpatentability. On our affirmance that the PTO has not established unpatentability, Apple is “entitled to a patent.” 35 U.S.C. § 102(a). That ends the examination procedure.

In examination appeals, the PTO and the PTAB are not,neutral arbiters; they bear the burden of establishing unpatenta-bility. This is a critical difference between an examination appeal and the new post-grant AIA procedures. On examination, the statute provides: “A person shall be entitled to a patent unless—.” 35 U.S.C. 102(a). Thus the burden of establishing unpatentability rests with the PTO during examination. If the PTO fails to carry that burden, by statute the applicant is “entitled to a patent.” Our predecessor court explained:

The Patent Office has the initial duty of supplying the factual basis for its rejection. It may not, because it may doubt that the invention is patentable, resort to speculation, unfounded assumptions or hindsight reconstruction to supply deficiencies in its factual basis.

Application of Warner, 379 F.2d 1011, 1017 (CCPA 1967).

When.the Patent Office, as it did here, relies on the “naked invocation of skill in the art to supply a suggestion to combine the references,” with no adequate explanation, reasoning, or analysis, the statutorily required result is reversal. In re Rouffet, 149 F.3d 1350, 1359 (Fed. Cir. 1998) (“Absent any proper motivation to combine part of Levine’s teachings with Freeburg’s satellite system, the rejection of Rouffet’s claim over these references was improper and is reversed.”); see also In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992) (reversing for “improperly combined” references,-because “[i]f examination at the initial stage does not produce a prima facie case of unpatentability, then without more the applicant is entitled to grant of the patent”) (internal citation omitted).

The panel majority describes the Board’s reasoning as “potentially -lawful but insufficiently or inappropriately explained,” as contrasted with “so crippled as to be unlawful.” In re Lee, 277 F.3d 1338, 1346 (Fed. Cir. 2002). (internal citations omitted). Although this distinction may. be a “fine line,” id. for the Van Os application the Board’s reasoning does not come close to “potentially lawful” reasoning, unlike the examples cited by the majority. The facts herein are much closer to those of Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1366 (Fed. Cir. 2016) (reversing, in an inter partes review, because “this is not a case where a more reasoned explanation than that provided by the Board can be gleaned from the record”).

Unlike the facts of In re Lee, the issue here is not a lack of specificity or absence of citation to the record or to legal authority. Lee, 277 F.3d at 1343-44 (remanding for further explanation when examiner’s suggested motivations to combine lacked “specificity” and were based on “unknown authority”). Nor is the Van Os application defective simply due to incorrect construction of a claim term, as in Power Integrations, Inc. v. Lee, 797 F.3d 1318, 1325-26 (Fed. Cir. 2015) (“Because we vacate the Board’s construction of the ‘coupled’ limitation in claim 1, we likewise vacate and remand its anticipation rejections of claims 17,18, and 19.”).

Instead, the Board and the examiner, without citation or explanation, justified the combination of Gillespie’s sustained touch on a computer mousepad to initiate the editing menu on Hawkins’ portable electronic device. The Board’s statement that it would have been “intuitive” to combine the two is not a legally sufficient explanation. Neither the examiner nor the Board met the statutorily required burden of demonstrating unpatentability, although they had full opportunity to do so. This lack of reasoning is “so crippled as to be unlawful.” Lee, 277 F.3d at 1346.

On our recognition and affirmation that the PTÓ failed to meet its statutory burden, the appropriate remedy is to instruct that the claims be allowed and the patent granted.


author: HUGHES, Circuit Judge.

text:
    Jessie CONTRERAS, Petitioner-Appellant v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent-Appellee
    2015-5097
    United States Court of Appeals, Federal Circuit.
    Decided: January 3, 2017

      Jeffrey S. Pop, Jeffrey S. Pop & Associates, Beverly Hills, CA, argued for petitioner-appellant.
    Voris Edward Johnson, Jr., Vae-cine/Torts Branch, Civil Division, United States Department of Justice, Washington, DC, argued for respondent-appellee. Also represented by Benjamin C. Mizer, Vincent J. Matanoski, Rupa Bhattacharya, Linda Sara Renzi.
    Before DYK, MAYER, and HUGHES, Circuit Judges.
   HUGHES, Circuit Judge.

Jessie Contreras appeals from a U.S. Court of Federal Claims judgment upholding a Special Master’s denial of compensation for his Guillain-Barre Syndrome and Transverse Myelitis allegedly caused by vaccinations. Because the Special Master improperly diagnosed Mr. Contreras and tailed to consider relevant evidence related to his Guillain-Barre Syndrome, we vacate and remand for further proceedings consistent with this opinion.

I

On June 16, 2003, Jessie Contreras (Mr. Contreras), then thirteen years old, received the Tetanus-Diphtheria vaccine and his third inoculation of the Hepatitis B vaccine. Before he received these vaccinations, Dr. Fred Kyazze conducted a complete physical examination and determined that Mr. Contreras was healthy.

Approximately twenty-four hours later, Mr. Contreras complained to his mother that he was experiencing back pain and numbness in his hands. She immediately took Mr. Contreras to the emergency room, where Dr. Mark Wagner, a board-, certified emergency room physician, diagnosed him with atypical Guillain-Barre Syndrome (GBS), a peripheral nervous system disease that causes descending paralysis from the upper to lower extremities. J.A. 281; 586. Mr. Contreras’s symptoms rapidly escalated—within hours he had difficulty standing or walking, weakness in his arms, and required catheterization. Mr. Contreras was ultimately transferred to the pediatric intensive care unit at Miller Children’s Hospital.

Upon admittance at Miller Children’s, Mr. Contreras was described as presenting “progressive neuromuscular deterioration and life-threatening respiratory failure.” J.A. 288. Over the next three months, Mr. Contreras suffered from a variety of symptoms caused by his illness, including quadriplegia and acute respiratory failure. J.A. 289. Mr. Contreras was discharged from Miller Children’s on September 11, 2003, with a discharge diagnosis of Transverse Myelitis (TM), an inflammatory disease of the spinal cord. J.A. 289; J.A. 608.

On June 15,2005, Mr. Contreras’s father filed a petition for vaccine compensation under the Vaccine Act, alleging that Mr. Contreras suffered TM and GBS as the result of the vaccinations administered on June 16, 2003. Mr. Contreras’s petition included affidavits from: (1) Dr. Kyazze; (2) Dr; Wagner; and (3) Dr. Jeremy S. Garrett, a general pediatrician and critical care physician, who treated Mr. Contreras during his admission to Miller Children’s and ultimately diagnosed him with TM. Mr. Contreras also filed the expert report of pediatric neurologist Dr. Charles M. Poser, M.D., who concluded that he developed GBS and TM as a direct result of the administration of the vaccines.

-On October 7, 2005, the Secretary of Health and Human Services filed her Vaccine Rule 4 Report indicating that Mr. Contreras was not entitled to compensation because he had failed to establish, by a preponderance of the evidence, that either vaccine caused his condition. The Secretary also filed the expert report of pediatric-neurologist John T. Sladky, M.D., who opined that Mr. Contreras only suffered from TM, not both TM and GBS, and that the time interval—less than twenty-four hours between the administration of Mr. Contreras’s vaccines and the onset of his TM—was too soon for one or both of the vaccinations to have caused his condition.

To address whether Mr. Contreras’s illness had occurred within a medically-appropriate time-frame, Mr. Contreras submitted the medical expert report of pediatric neurologist Lawrence Steinman, M.D., who concluded that Mr. Contreras developed both GBS and TM caused by a rapid adverse immunological response to both vaccinations. In- response to Dr. Steinman’s report, the Secretary filed an expert report from immunologist J. Lindsay Whitton, M.D., Ph.D., who agreed that Mr. Contreras suffered from both GBS and TM, but disputed Dr. Stein-man’s theory of causation and the timing of Mr. Contreras’s condition in relation to his vaccinations, reiterating that -twenty-four hours was not enough time for either TM or GBS to develop after, vaccination.

On April 5, 2012, the Special Master issued his first decision (Contreras I) denying Mr; Contreras compensation under the Vaccine Act. See J.A. 30-64. The Special Master determined that Mr. Contreras only suffered from TM, not both TM and GBS. The Special Master then concluded that Mr. Contreras failed to establish that the TM arose within a “medically appropriate” timeframe following his vaccinations under the third prong of Althen v. Secretary of Health & Human Services, 418 F.3d 1274 (Fed. Cir. 2005). J.A. 62-63.

Mr. Contreras sought review and on September 28, 2012, the Court of Federal Claims vacated and remanded Contreras I after concluding that the Special Master’s finding of a specific diagnosis was not in accordance with law (Contreras II). The Special Master was instructed, on remand, to refrain from making a determination regarding Mr. Contreras’s specific diagnosis. The Special Master was also instructed to analyze the evidence under all three prongs of Althen, address the weight afforded to Mr. Contreras’s treating physicians, address whether Mr. Contreras had ruled out all alternative causes for his condition, consider case reports, and more thoroughly discuss the evidence proffered in Dr. Poser’s report. J.A. 110-13.

During the pendency of the decision on remand, the Secretary filed a status report disclosing that Dr. Sladky’s medical license was suspended during the time that he had provided the Government with expert witness services in this ease. J.A. 118. Moreover, Dr. Sladky’s CV indicated that he was licensed to practice medicine in Pennsylvania, but that license expired in 1996, nine years before his initial report was filed in this case. Id. The Secretary maintained that these “undisclosed licensure issues should not affect the evidentiary weight of his opinions.” J.A. 119. Mr. Contreras disagreed and argued that Dr. Sladky’s testimony should “carry little, if any weight,” J.A. 118, because his “lack of transparency and untruthfulness ,.. bear on his bias and character critically undermining his credibility as an expert,” J.A. 119 (omission in original).

On November 19, 2013, the Special Master again denied Mr. Contreras compensation (Contreras III). J.A. 114-90. First, the decision found ‘that Dr. Sladky’s opinion “retain[ed] some value” after determining that “the lack of disclosure and (implicit) misrepresentation about qualification do[] not entirely negate [his] opinion.” J.A. 120. Next,, the Special Master determined that Mr. Contreras did not suffer from GBS—a direct violation of the court’s instruction to refrain from diagnosing Mr. Contreras— and therefore based his analysis solely on the TM diagnosis. J.A. 143-45. Finally, he determined that “the one-day interval is not a time-frame.for which it is medically acceptable” to conclude that the vaccine caused the injury. J.A. 189.

Mr. Contreras again sought review and on May 19, 2014, the Court of Federal Claims vacated and remanded Contreras III (Contreras IV). J.A. 191-214, The Court of Federal Claims was highly critical of the Special Master’s finding that Dr. Sladky’s opinion retained “some value” in light of his failure to disclose his suspended medical license and his lack of candor during his testimony regarding his credentials and job description. J.A, 212. On remand, the Special Master was instructed to: (1) address Dr. Sladky’s credibility and reliability in light of his misrepresentations; (2) compare Dr. Sladky’s credibility to the credibility of the experts and witnesses testifying for Mr. Contreras; and (3) issue an alternative ruling that completely disregards all of Dr. Sladky’s opinions and testimony. J.A. 212-13.

On October 24, 2014, the Special Master issued a second Decision on Remand denying Mr. Contreras compensation (Contreras V). J.A. 215-74. The Special Master again determined that although Dr. Sladky had misrepresented his credentials, J.A. 242, his opinions were based upon “reliable methodologies” and, therefore, retained some value, J.A. 244-45. The Special Master also issued an alternative opinion that disregarded the opinions and testimony of Dr. Sladky, and concluded that Mr. Contreras’s expert, Dr. Steinman, had failed to establish by a preponderance of the evidence a proximate temporal relationship between the vaccination and the injury as required under prong three of Althen. J.A. 265-66; 273-74.

Mr. Contreras sought review for a third time, which the Court of Federal Claims denied on April 17, 2015 (Contreras VI). The court determined that the Special Master abused his discretion by crediting Dr. Sladky’s opinion and therefore vacated the entitlement ruling in Contreras III, which was incorporated into Contreras V. J.A. 7-18. The court also found that the Special Master erred by conducting a “threshold inquiry into the specific diagnosis of [Mr. Contreras’s] alleged vaccine injury,” and by imposing “a higher burden on petitioner [on Althen prong one] than is appropriate under Federal Circuit precedent,” but that both errors were harmless, See J.A. 22-23; 26. Finally, the court determined that the Special Master’s. alternate ruling on Althen prong three—that twenty-four hours was too short of time to develop TM or GBS after a vaccine—contained no error of law or abuse of discretion. J.A. 27. Therefore, the court denied the petition for review.

Mr. Contreras appeals. We' have jurisdiction under 42 U.S.C. § 300aa-12(f).

II

The Federal Circuit .reviews an appeal from the Court of Federal Claims in a Vaccine Act case de novo, “applying the same standard of review as the Court of Federal Claims applied to its review of the special master’s decision.” Griglock v. Sec’y of Health & Human Servs., 687 F.3d 1371, 1374 (Fed. Cir. 2012) (citation omitted); see also Paluck v. Sec’y of Health & Human Servs., 786 F.3d 1373, 1378 (Fed. Cir. 2015). “We give no deference to the Claims Court’s or Special Master’s deter minations of law, but uphold the Special Master’s findings of fact unless they are arbitrary or capricious.” Griglock, 687 F.3d at 1374 (citation omitted). We review discretionary rulings—i.e., exclusion of evidence or limitation of the record upon which the special master relies—under the abuse of discretion standard. Munn v. Sec’y of Health & Human Servs., 970 F.2d 863, 870 n.10 (Fed. Cir. 1992). Ultimately, “if the special master ‘has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision, reversible error will be extremely difficult to demonstrate.’” Hibbard v. Sec’y of Health & Human Servs., 698 F.3d 1355, 1363 (Fed. Cir. 2012) (quoting Hines ex rel. Sevier v. Sec’y of the Dep’t of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)).

To establish that the vaccine caused the injury, a petitioner must prove, by a preponderance of the evidence: (1) a medical theory causally connecting the vaccination to the injury; (2) a logical sequence of cause and effect demonstrating that the vaccination caused the injury; and (3) a proximate temporal relationship between the vaccine and the injury. Althen, 418 F.3d at 1278.

Here, the Court, of Federal Claims determined that the Special Master erred by conducting a “threshold inquiry into the specific diagnosis of Jessie’s alleged vaccine injury,” but that the error was harmless. We disagree.

In Hibbard, this court determined that if there is a dispute as to the nature of a petitioner’s injury, the special master may opine on the nature of the petitioner’s injury. 698 F.3d at 1365. Here, however, there was no dispute as to the nature of Mr. Contreras’s injury—both parties’ experts agreed that he suffered from TM and GBS. Nee J.A. 379; 426. Therefore, the Special Master erred by concluding that Mr. Contreras only suffered from TM and not both TM and GBS.,

That error was harmful. Based on this improper diagnosis, the Special Master did not consider relevant evidence related to GBS in his Althen analysis. See J.A. 256 (“Mr. Contreras did not suffer from Guil-lain-Bai’re syndrome.”); J.A. 145 (“[T]he following Althen analysis is limited to the issue of whether the hepatitis B vaccine can cause transversé myelitis.”); J.A. 63 (“The testimony of ... Dr. Whitton was consistent with medical literature that shows that, at a minimum, the blood brain barrier [which is only implicated in TM] would prevent an immune-mediated reaction in the spinal cord in one day.”); id. (“[Dr. Whitton’s] opinion is that ‘there is no credible hypothesis that would explain a 24-hour timeframe, which would tie a vaccine causally to the induction of such a profound central nervous system disease [TM].’” (citation omitted)). Although the Special Master noted that Dr. Whitton’s conclusion “would not change depending upon the demyelinating disease,” J.A. 257, this does not mean that the Special Master considered evidence related to demyelinat-ing disease GBS. In fact, to the contrary, the record supports the conclusion that the Special Master failed to consider the medical theories advanced jay Dr. Steinman and Dr. Whitton relating to Mr. Contreras’s GBS diagnosis. See id.

Because TM and GBS are separate diagnoses that affect different parts of the nervous system, we find that the Special Master committed reversible error by failing to consider relevant evidence related to GBS. Therefore, this case must be remanded once again for a proper consideration of the evidence.

Ill

Ordinarily, this case would be remanded to the originally assigned Special Master. See Richardson ex rel. Richardson v. Sec’y of Health & Human Servs., 89 Fed.Cl. 657, 660 (2009). In this instance, however, we believe that fundamental fairness is best served by assigning the case to a different special master on remand. See id.; Vaccine Rule 3(d).

This case has a lengthy history, including two separate remands before the present appeal. The Special Master has consistently maintained that Mr. Contreras only suffers from TM—despite specific instructions that he must consider both the TM and GBS diagnoses. See J.A. 111 (“Thé special master may not diagnose Jessie’s illness, but shall examine whether petitioner has established a prima facie case that he suffered a vaccine-related combination of TM and GBS.”). Given that the Special Master has maintained an erroneous viewpoint throughout this case, despite instructions to the contrary, we advise that this case be assigned to a different special master on remand. See United States v. Robin, 553 F.2d 8, 10 (2d Cir. 1977) (“[Reassignment is advisable] [w]here a judge has made detailed findings based on evidence erroneously admitted or factors erroneously considered, [because] the circumstances sometimes are such that upon remand he or she ... cannot reasonably be expected to erase the .earlier impressions from his or her mind.... ”); id. at 11 (“[W]here a judge has repeatedly adhered to an erroneous view after the error is called to his attention, reassignment to another judge may be advisable in order to avoid an exercise in futility (in which) the Court is merely marching up the hill only to march right down again.” (internal quotation marks and citations omitted)).

IV

Because the Special Master committed reversible error by failing to consider relevant evidence related to Mr. Contreras’s Guillain-Barre Syndrome, we vacate and remand for further proceedings consistent with this opinion. On remand, the newly assigned special master shall issue comprehensive findings and conclusions as to all issues. In light of our' disposition, we need not address the appellant’s Other asserted errors, which may well be obviated by the findings and conclusions of the new special master on remand:

VACATED AND REMANDED

Costs to Contreras.

      . Although TM and GBS are both "diseases in which portions of the nervous system are de-myelinated,” J.A. 41, TM affects the central nervous system, which is protected by the blood-brain barrier, see J.A, 459, and GBS affects the peripheral nervous system, which is not protected by the blood-brain barrier, see id.