Document ID: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-ca13-15-01696/USCOURTS-ca13-15-01696-0/pdf.json

Parties Involved:
Abbott Laboratories
Appellee
Boston Scientific Scimed
Appellee
Cordis Corporation
Appellant
Ethicon, Inc.
Appellant

Document Text:

United States Court of Appeals 

for the Federal Circuit ______________________ 

IN RE: ETHICON, INC., 

A JOHNSON & JOHNSON COMPANY,

Appellant

______________________ 

2015-1696

______________________ 

Appeal from the United States Patent and Trademark 

Office, Patent Trial and Appeal Board in Nos. 95/000,542, 

95/000,552.

______________________ 

Decided: January 3, 2017

______________________ 

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.

Opinion for the court filed by Circuit Judge LOURIE. 

Dissenting opinion filed by Circuit Judge NEWMAN. 

LOURIE, Circuit Judge. 

Case: 15-1696 Document: 81-2 Page: 1 Filed: 01/03/2017
2 IN RE: ETHICON, INC. 

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 owns1 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 polyvinylidenefluoride [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 During the pendency of this appeal, Cordis Corporation assigned the ’844 patent to Ethicon. For simplicity, 

we refer to the owner of the ’844 patent throughout as 

Ethicon.

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IN RE: ETHICON, INC. 3

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, 

Case: 15-1696 Document: 81-2 Page: 3 Filed: 01/03/2017
4 IN RE: ETHICON, INC. 

arguing that the examiner erred in combining the prior 

art references and by discounting the objective indicia. 

Tuch discloses intravascular stents, including balloonexpandable 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 polytetrafluoroethylene/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 

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IN RE: ETHICON, INC. 5

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)/elastomer 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. 

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6 IN RE: ETHICON, INC. 

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).

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 

Case: 15-1696 Document: 81-2 Page: 6 Filed: 01/03/2017
IN RE: ETHICON, INC. 7

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

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8 IN RE: ETHICON, INC. 

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 functions,” id. at 

417, and apply “an expansive and flexible approach” to 

obviousness, id. at 415. 

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 ll. 14–16. Tuch explains that 

coating overlayers “made with materials which have little 

elasticity . . . can sustain significant cracking during 

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IN RE: ETHICON, INC. 9

[stent] deformation” and that such cracking can result in 

more rapid elution of drugs. Id. col. 7 ll. 11–15. Tuch 

teaches that “inclusion of a polymer in intimate contact 

with a drug on the stent allows the drug to be retained on 

the stent in a resilient[, i.e., elastic,] matrix during expansion of the stent and also slows the administration of drug 

following implantation.” Id. col. 2 ll. 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 ll. 61–64, and lists 

VDF:HFP first in its list of preferred elastomers, id. at 

col. 4 ll. 30–32. Lo similarly teaches VDF:HFP copolymers with “varying degrees of flexibility, elasticity and 

extensibility,” Lo col. 2 ll. 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 

ll. 15–36. These teachings of all of the required components of the claims support the Board’s combination of the 

three references to 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 

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10 IN RE: ETHICON, INC. 

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 ll. 16–17 (emphasis added), and lists VDF as an 

example of a suitable biostable polymer, id. col. 5 ll. 33–

53. Although Tuch states that a “bioabsorbable polymer 

is probably more desirable,” id. col. 5 ll. 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 MateriCase: 15-1696 Document: 81-2 Page: 10 Filed: 01/03/2017
IN RE: ETHICON, INC. 11

als, 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(tetrafluoroethylene)/elastomer layer and migrate into the lumen,” Tu 

col. 8 ll. 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 ll. 36–40, and 

an alternative embodiment where the “combination of 

layers provides for better hydrophilicity due to the elastomer in the luminal layer,” id. col. 9 ll. 56–60. See also 

id. col. 1 ll. 27–32, col. 9 ll. 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 

ll. 11–18. 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 

(“A person of ordinary skill is also a person of ordinary 

creativity, not an automaton.”).

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12 IN RE: ETHICON, INC. 

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, Ethicon’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.

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IN RE: ETHICON, INC. 13

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

Case: 15-1696 Document: 81-2 Page: 13 Filed: 01/03/2017
United States Court of Appeals 

for the Federal Circuit ______________________ 

IN RE: ETHICON, INC., 

A JOHNSON & JOHNSON COMPANY,

Appellant

______________________ 

2015-1696

______________________ 

Appeal from the United States Patent and Trademark 

Office, Patent Trial and Appeal Board in Nos. 95/000,542, 

95/000,552.

______________________ 

NEWMAN, Circuit Judge, dissenting.

United States Patent No. 7,591,844 (“the ’844 Patent”) 

is for a balloon-expandable vascular stent having a drugeluting 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 coCase: 15-1696 Document: 81-2 Page: 14 Filed: 01/03/2017
2 IN RE: ETHICON, INC. 

polymer 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, l. 59–col. 38, l. 3. It was generally 

agreed that the novelty and advantages are due to the 

specific copolymer coating material for the balloonexpandable 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 drugeluting coating in a vascular stent, nor were its advantages foreseen. Nonetheless the Board deemed it

obvious,1 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 

 

1 Boston Scientific Scimed v. Cordis Corp., No. 

2014-008135, 2015 WL 883933 (P.T.A.B. Feb. 27, 2015) 

(“Board Op.”). The successful requesters 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.

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IN RE: ETHICON, INC. 3

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 comonomers, 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 polymers that could be used include poly(Llactic acid), polycaprolactone, poly(lactide-coglycolide), poly(hydroxybutyrate), poly(hydroxyCase: 15-1696 Document: 81-2 Page: 16 Filed: 01/03/2017
4 IN RE: ETHICON, INC. 

butyrate-co-valerate), polydioxanone, polyorthoester, polyanhydride, poly(glycolic acid), poly(D,Llactic acid), poly(glycolic acid-co-trimethylene carbonate), polyphosphoester, polyphosphoester urethane, poly(amino acids), cyanoacrylates, 

poly(trimethylene carbonate), poly(iminocarbonate), copoly(ether-esters) (e.g. PEO/PLA), 

polyalkylene oxalates, polyphosphazenes 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 polyolefins, polyisobutylene and ethylene-alphaolefin 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 polyvinylidene 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 methacrylate copolymers, acrylonitrile-styrene copolymers, ABS resins, and ethylene-vinyl acetate 

copolymers; polyamides, such as Nylon 66 and 

polycaprolactam; alkyd resins; polycarbonates; 

polyoxymethylenes; polyimides; polyethers; epoxy 

resins; polyurethanes; rayon; rayon-triacetate; cellulose, cellulose acetate, cellulose butyrate; cellulose acetate butyrate; cellophane; cellulose 

nitrate; cellulose propionate; cellulose ethers; and 

carboxymethyl cellulose.

Tuch, col 5, ll. 16–53.

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IN RE: ETHICON, INC. 5

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.” 

LeoPharma Prods., Ltd. v. Rea, 726 F.3d 1346, 1356–57 

(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., 575 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 stated: 

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 drugeluting 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 

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6 IN RE: ETHICON, INC. 

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 hydrophobicity, 

compliance, strength and elasticity.” Tu, col. 2, ll. 7–11. 

The first Tu layer is made of poly(tetrafluoroethylene), 

the second layer is “a mixture of poly(tetrafluoroethylene) 

and elastomer,” and an optional third layer is made of 

“elastomer.” Tu, col. 3, ll. 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 polyvinylidene fluoride cohexafluoropropylene, poly(tetrafluoroethylene-coperfluoro(methylvinylether)), poly(tetrafluoroethylene-co-propylene), poly(vinylidene-co-chlorotrifluoroethylene), silicones, fluorosilicones, 

fluoroalkoxy phosphazenes, segmented copolyester ether, styrene butadiene block copolymers, 

polyethers[,] acrylonitrile butadienes, isoprenes, 

polyurethanes, and mixtures thereof.

Tu, col. 4, ll. 30–39. Tu’s preferred elastomers are a 

copolymer of tetrafluoroethylene and propylene, and 

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IN RE: ETHICON, INC. 7

silicone. Tu, col. 4, ll. 61–66; col. 5, l. 7. The Board stated: 

The reason to consult Tu is because Tuch’s list of 

polymers is clearly not exhaustive in view 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, ll. 66–68; 

col. 9, ll. 12–14, excluding the ’844 Patent product’s temperature ceiling of “60° C during the coating process or 

afterward.” ’844 Patent, col. 37, l. 66–col. 38, l. 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 multilayered suturable 

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8 IN RE: ETHICON, INC. 

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(tetrafluoroethylene), poly(tetrafluoroethylene)/elastomer, elastomer and fibrous elastomers. 

Tu, col. 2, ll. 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 copolymer 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” exercise 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 

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IN RE: ETHICON, INC. 9

copolymers with a 60.6/39.4 ratio are “marketed as elastomers.” ’844 Patent, col. 20, ll. 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 (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 by Lo, 

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) 

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10 IN RE: ETHICON, INC. 

e.g. in electrical tapes, magnetic recording tapes, 

etc., and as protective coatings on tanks, storage 

vessels and the like.

Lo, col. 10, ll. 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. Feil, 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. 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 (1966) (“Such secondary 

considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to 

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IN RE: ETHICON, INC. 11

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 decisionmaker remains in 

doubt after reviewing the art.”); In re Mageli, 470 F.2d 

1380, 1383 (C.C.P.A. 1973) (“[E]vidence 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 drug-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 thromboresistant (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 

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12 IN RE: ETHICON, INC. 

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, ll. 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, ll. 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, ll. 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.” 

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IN RE: ETHICON, INC. 13

’844 Patent, col. 20, ll. 22–24. Those copolymers, when 

mixed with rapamycin and dried at the claimed temperature, produced “a white film, indicating phase separation 

of the drug and the polymer.” ’844 Patent, col. 20, ll. 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, ll. 53–55. Additional 

comparative data in the ’844 Patent showed differences in

the fraction of drug released over time between the 

claimed 85/15 copolymer and the 60.6/39.4 copolymer of 

vinylidene fluoride and hexafluoropropylene without a 

topcoat. ’844 Patent, Figs. 3 and 5; col. 21, ll. 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% 

hexafluoropropylene. 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 are not analogous to vascular stents. No combination of references suggests utilization of the ’844 Patent’s copolymer in drug-eluting vascular stents. 

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14 IN RE: ETHICON, INC. 

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.

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