IN RE: ETHICON, INC., A JOHNSON & JOHNSON COMPANY, Appellant
from the United States Patent and Trademark Office, Patent
Trial and Appeal Board in Nos. 95/000, 542, 95/000, 552.
Lucci, Baker & Hostetler LLP, Philadelphia, PA, argued
for appellant. Also represented by John Frank Murphy, Charlie
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.
Newman, Lourie, and Dyk, Circuit Judges.
Lourie, Circuit Judge
Ethicon, Inc. ("Ethicon") appeals from the U.S.
Patent and Trademark Office ("PTO") Patent Trial
and Appeal Board's ("the Board's") decision
in a merged inter partes reexamination affirming the
examiner's obviousness rejection of claims 1-17 and 19-23
of U.S. Patent 7, 591, 844 ("the '844 patent").
See Boston Sci. SCIMED v. Cordis Corp., No.
2014-008135, 2015 WL 883933 (P.T.A.B. Feb. 27, 2015)
("Decision"). Because the Board did not
err in its obviousness conclusion, we affirm.
the '844 patent, which relates to intraluminal medical
devices for the local delivery of drugs, e.g.,
drug-eluting stents, and methods for maintaining drugs on
those devices. '844 patent col. 1 ll. 21-31, col. 5 ll.
50-57. Angioplasty can be used to alleviate blockages of
blood vessels. Id. col. 1 ll. 33-46. However,
expansion of the balloon catheter during angioplasty can
result in injury to the smooth muscle cells within the vessel
wall, which can lead to restenosis, the gradual re-closure of
the vessel. Id. col. 1 l. 46-col. 2 l. 45. The
'844 patent teaches that stent coatings themselves, and
stent coatings delivering drugs locally, may be capable of
reducing restenosis. Id. col. 4 ll. 43-54. The
'844 patent teaches that previously "[s]tents with
coatings made from polyvinylidenefluo-ride [VDF] homopolymers
and containing pharmaceutical/therapeutic agents or drugs for
release have been suggested." Id. col. 5 ll.
is representative of the challenged claims and reads as
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.
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.
the reexamination, Ethicon cancelled claims 18 and 24 by
amendment. The examiner rejected remaining claims 1-17 and
19-23 as obvious over, inter alia, U.S. Patent 5,
824, 048 ("Tuch"), U.S. Patent 4, 816, 339
("Tu"), and U.S. Patent 3, 178, 399
("Lo"), and relied on a translation of Fr. Patent
2, 785, 812 ("Le Morel") to reject certain
dependent claims. The examiner found that the evidence
submitted by Ethicon regarding objective indicia of
nonobviousness was insufficient to outweigh the conclusion of
obviousness. Ethicon appealed to the Board, arguing that the
examiner erred in combining the prior art references and by
discounting the objective indicia.
discloses intravascular stents, including balloon-expandable
stents, with a coating on the tissue-contacting surface that
includes a polymer and a drug. Tuch col. 2 ll. 35-42, col. 4
ll. 10-13. Tu discloses implantable medical devices such as
vascular grafts and heart valve leaflets made from a
multi-layered polytetrafluoroeth-ylene/elastomer material. Tu
col. 1 ll. 21-32. Tu lists VDF:HFP copolymer first in its
list of potential elastomers, id. col. 4 ll. 30-32,
and states that the elastomer may contain drugs,
e.g., heparin, for release into the surrounding
environment, id. col. 9 ll. 65-68. Lo discloses
properties of VDF:HFP copolymer at various weight ratios,
including 85:15. Lo Fig. 1, col. 9 ll. 15-36. Le Morel
discloses stents with a VDF:HFP coating. J.A. 10748-49.
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.
Board additionally found that Tuch discloses "a problem
with coatings with low elasticity, " id. at
*10, and that biocompatibility and elasticity are
"useful" characteristics for the polymer in its
stent coatings, id. at *9. See also id. at
*4-5. The Board found that "[s]ince Tuch teaches a
problem with cracking when materials having little elasticity
are utilized in the polymer layer, one of ordinary skill in
the art would have reasonably sought materials with high
elasticity to avoid the problem when the stent is
expanded." Id. at *9.
Board then analyzed Tu and Lo in light of Tuch's
teachings. Tu states that "[i]t is not desired to have
the elastomer permeate the
poly(tetrafluoroethylene)/elasto-mer layer and migrate into
the lumen." Tu col. 8 ll. 40- 43. The Board found that
this statement only relates to a particular embodiment and
that Tu also teaches that the
poly(tetrafluoroethylene)/elastomer layer can be used in
medical devices such as heart valve leaflets where the
VDF:HFP elastomer would be in contact with blood.
Decision, at *5, *8. The Board additionally found
that Tu teaches that VDF:HFP copolymer possesses the useful
properties of biocompatibility and elasticity taught by Tuch
and that it is also useful for coatings containing a
therapeutic substance. Id. at *5, *9-10.
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.
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.
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
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.
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).
review of a Board decision is limited. In re Baxter
Int'l, Inc., 678 F.3d 1357, 1361 (Fed. Cir. 2012).
We review the Board's legal determinations de
novo, In re Elsner, 381 F.3d 1125, 1127 (Fed.
Cir. 2004), but we review the Board's factual findings
underlying those determinations for substantial evidence,
In re Gartside, 203 F.3d 1305, 1316 (Fed. Cir.
2000). A finding is supported by substantial evidence if a
reasonable mind might accept the evidence to support the
finding. Consol. Edison Co. of New York v. NLRB, 305
U.S. 197, 229 (1938).
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).
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.
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.
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.
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.
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 ...