In Re: Ethicon, Inc.

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 repre-
sented 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.
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 owns 1 the ’844 patent, which relates to intra-
luminal 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 deliver-
ing drugs locally, may be capable of reducing restenosis.
Id. col. 4 ll. 43–54. The ’844 patent teaches that previous-
ly “[s]tents with coatings made from polyvinylidenefluo-
ride [VDF] homopolymers and containing
pharmaceutical/therapeutic agents or drugs for release
have been suggested.” Id. col. 5 ll. 4–6.
Claim 1 is representative of the challenged claims and
reads as follows:
1 During the pendency of this appeal, Cordis Corpo-
ration assigned the ’844 patent to Ethicon. For simplicity,
we refer to the owner of the ’844 patent throughout as
Ethicon.
IN RE: ETHICON, INC. 3
1. A device for intraluminal implantation in a
vessel comprising a balloon-expandable stent
and a pharmaceutical agent-containing coat-
ing, 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 in-
termixed with said copolymer, wherein said
coating has not been subjected to a maxi-
mum temperature greater than 60° C. [sic]
during the coating process or afterward,
thereby providing an adherent coating that
remains adhered to the device upon expan-
sion of the balloon-expandable stent.
’844 patent col. 37 l. 59−col. 38 l. 3.
Ethicon sued Boston Scientific SCIMED (“Boston Sci-
entific”) and Abbott Laboratories (“Abbott” and, collective-
ly 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 remain-
ing 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 con-
clusion of obviousness. Ethicon appealed to the Board,
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 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 elasto-
mers, 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 poly-
mer. 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” character-
istics 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
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)/elasto-
mer layer and migrate into the lumen.” Tu col. 8 ll. 40–
43. The Board found that this statement only relates to a
particular embodiment and that Tu also teaches that the
poly(tetrafluoroethylene)/elastomer layer can be used in
medical devices such as heart valve leaflets where the
VDF:HFP elastomer would be in contact with blood.
Decision, at *5, *8. The Board additionally found that Tu
teaches that VDF:HFP copolymer possesses the useful
properties of biocompatibility and elasticity taught by
Tuch and that it is also useful for coatings containing a
therapeutic substance. Id. at *5, *9–10.
The Board similarly found that Lo teaches that 85:15
VDF:HFP “is advantageous with respect to flexibility,
elasticity, extensibility, tensile strength, and reverse
elongation.” Id. at *10. The Board found that a skilled
artisan would have been motivated to use 85:15
VDF:HFP, possessing these advantageous properties, as
the polymer in Tuch’s stent because “Tuch teaches a
problem with coatings with low elasticity.” Id. The Board
also found that “the skilled worker would have reasonably
consulted Lo to determine the optimal concentrations for
each component, even if Lo does not teach the use of
VDF:HFP for medical implants.” Id.
The Board also considered Ethicon’s evidence regard-
ing 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 ob-
tained by, and industry praise for certain stents sold by
the Requesters to support its argument that the claims
would not have been obvious.
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 Interna-
tional 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 sup-
ported by substantial evidence if a reasonable mind might
IN RE: ETHICON, INC. 7
accept the evidence to support the finding. Consol. Edi-
son 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 rele-
vant 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 obvious-
ness 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 mo-
tivated to combine analogous art. Prior art is analogous
where either (1) “the art is from the same field of endea-
vor, 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
8 IN RE: ETHICON, INC.
combined the prior art references to create the claimed
invention. Specifically, Ethicon argues that Tuch pro-
vides no motivation to select polymers other than those it
describes and that neither Tuch nor Tu provide a motiva-
tion 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 sup-
ports the Board’s factual findings, and the Board’s obvi-
ousness 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 im-
provement 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 un-
der the circumstances to support its obviousness conclu-
sion and those findings are supported by substantial
evidence. Tuch teaches that the polymer must be “bio-
compatible.” Tuch col. 5 ll. 14–16. Tuch explains that
coating overlayers “made with materials which have little
elasticity . . . can sustain significant cracking during
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 expan-
sion of the stent and also slows the administration of drug
following implantation.” Id. col. 2 ll. 42–46. Those teach-
ings 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 regard-
ing 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 copoly-
mers 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 compo-
nents of the claims support the Board’s combination of the
three references to address the problem regarding elastic-
ity 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 bioabsorb-
able polymers. Second, Ethicon asserts that Tu is di-
rected 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
10 IN RE: ETHICON, INC.
medical devices. Ethicon asserts that Lo is directed to
coatings for harsh, industrial applications, not implanta-
ble 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 state-
ment, 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 configu-
rations 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 Materi-
IN RE: ETHICON, INC. 11
als, Inc., 692 F.3d 1289, 1298 (Fed. Cir. 2012) (“A refer-
ence must be considered for everything that it teaches,
not simply the described invention or a preferred embod-
iment.”).
Second, although Tu states that “[i]t is not desired to
have the elastomer permeate the poly(tetrafluoro-
ethylene)/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 embodi-
ment and its finding that Tu teaches that the elastomer
can be in contact with blood. Tu teaches that its inven-
tion 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 elas-
tomer 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 advanta-
geous 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 prop-
erties 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 in-
volved,” 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 motiva-
tion 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.”).
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 copoly-
mer 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 dis-
counting its proffered objective indicia of nonobviousness.
Ethicon asserts that copying, commercial success, indus-
try praise, and unexpected results support the nonobvi-
ousness of the ’844 patent.
The Director responds that Ethicon’s evidence regard-
ing 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 sub-
stantial 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 sup-
port its copying allegations. J.A. 3763. Regarding unex-
pected 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.
IN RE: ETHICON, INC. 13
CONCLUSION
We have considered all of Ethicon’s remaining argu-
ments, 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 rea-
sons set forth above, we affirm the Board’s decision.
AFFIRMED
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 drug-
eluting coating of a copolymer of vinylidene fluoride and
hexafluoropropylene in about 85/15 weight percent mon-
omer 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 co-
2 IN RE: ETHICON, INC.
polymer that comprises about eighty-five weight
percent vinylidine fluoride [VDF] copolymerized
with about fifteen weight percent hexafluoropro-
pylene [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 coat-
ing process or afterward, thereby providing an
adherent coating that remains adhered to the de-
vice 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 balloon-
expandable stent.
The references cited by the PTO Board recite thou-
sands 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 ad-
vantages 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.
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 comon-
omers, 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 bioab-
sorbable polymer depending on the desired rate of
release or the desired degree of polymer stability,
but a bioabsorbable polymer is probably more de-
sirable since, unlike a biostable polymer, it will
not be present long after implantation to cause
any adverse, chronic local response. Bioabsorba-
ble polymers that could be used include poly(L-
lactic acid), polycaprolactone, poly(lactide-co-
glycolide), poly(hydroxybutyrate), poly(hydroxy-
4 IN RE: ETHICON, INC.
butyrate-co-valerate), polydioxanone, polyortho-
ester, polyanhydride, poly(glycolic acid), poly(D,L-
lactic acid), poly(glycolic acid-co-trimethylene car-
bonate), polyphosphoester, polyphosphoester ure-
thane, poly(amino acids), cyanoacrylates,
poly(trimethylene carbonate), poly(imino-
carbonate), copoly(ether-esters) (e.g. PEO/PLA),
polyalkylene oxalates, polyphosphazenes and bi-
omolecules such as fibrin, fibrinogen, cellulose,
starch, collagen and hyaluronic acid. Also, biosta-
ble 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, poly-
isobutylene and ethylene-alphaolefin copolymers;
acrylic polymers and copolymers, vinyl halide pol-
ymers and copolymers, such as polyvinyl chloride;
polyvinyl ethers, such as polyvinyl methyl ether;
polyvinylidene halides, such as polyvinylidene flu-
oride and polyvinylidene chloride; polyacryloni-
trile, 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 meth-
acrylate copolymers, acrylonitrile-styrene copoly-
mers, 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; cel-
lulose, cellulose acetate, cellulose butyrate; cellu-
lose acetate butyrate; cellophane; cellulose
nitrate; cellulose propionate; cellulose ethers; and
carboxymethyl cellulose.
Tuch, col 5, ll. 16–53.
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 vascu-
lar stent. “[T]he breadth of these choices and the numer-
ous 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 copoly-
mer 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 pos-
sibilities 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 shortcom-
ings 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 estab-
lished 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
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 poly-
mers and copolymers, including the ’844 Patent’s copoly-
mer components:
The elastomer is preferably selected from the
group consisting of polyvinylidene fluoride co-
hexafluoropropylene, poly(tetrafluoroethylene-co-
perfluoro(methylvinylether)), poly(tetrafluoro-
ethylene-co-propylene), poly(vinylidene-co-chloro-
trifluoroethylene), silicones, fluorosilicones,
fluoroalkoxy phosphazenes, segmented copolyes-
ter 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
IN RE: ETHICON, INC. 7
silicone. Tu, col. 4, ll. 61–66; col. 5, l. 7. The Board stat-
ed:
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 spe-
cific 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 differ-
ent 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 tempera-
ture 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 tem-
perature 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 proper-
ties are not the properties of Tu’s multilayered suturable
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 pre-
sent invention has excellent compliance, strength
and elasticity because of the arrangement of lay-
ers of poly(tetrafluoroethylene), poly(tetrafluoro-
ethylene)/elastomer, elastomer and fibrous elas-
tomers.
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 mono-
mer 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 in-
sidious 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 hex-
afluoropropylene. The ’844 Patent demonstrates differ-
ences in the properties of various monomer ratios, in that
the 85/15 copolymers are “semicrystalline,” and that
IN RE: ETHICON, INC. 9
copolymers with a 60.6/39.4 ratio are “marketed as elas-
tomers.” ’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 ele-
ments 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 de-
scribed in the Lo reference as having a
unique combination of tensile strength and re-
versible elongation properties and are especially
suitable as durable, flexible coatings for applica-
tion 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 com-
prised of exposed surfaces which may be subjected
to bending, folding, or other forms of distortion in
the course of performing their function under spe-
cial environmental conditions. They may also be
used in film form (either oriented or unoriented)
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. Howev-
er, from Lo’s uses as boot and helmet coatings and electri-
cal 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 copoly-
mer, undifferentiated as to monomer ratio and copolymer
properties, does not fill the gaps in Tuch and Tu to sug-
gest use for a drug-eluting vascular stent.
The Board erred in its analysis, collecting the ele-
ments 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 copol-
ymer for use in a vascular stent.
The objective evidence
The “secondary considerations” are part of the obvi-
ousness 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 un-
solved needs, failure of others, etc., might be utilized to
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 objec-
tive evidence reflects the “temporal and technical perspec-
tive” of the invention. Mintz v. Dietz & Watson, Inc., 679
F.3d 1372, 1378 (Fed. Cir. 2012).
This evidence must be considered along with the en-
tirety 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 re-
sponse 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 throm-
boresistant (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
12 IN RE: ETHICON, INC.
Xience V stent shows unexpectedly less inflammation.”
Id.
The Board declined to consider the evidence of superi-
or properties and commercial success, stating:
This evidence is not persuasive since it does not
establish that the reduction in inflammation ob-
served 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 in-
flammatory 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 Pa-
tent, col. 19, ll. 24–28, 36–41. The ’844 Patent also com-
pared the 85/15 copolymer with copolymers having a
60.6/39.4 ratio, which were “marketed as elastomers.”
IN RE: ETHICON, INC. 13
’844 Patent, col. 20, ll. 22–24. Those copolymers, when
mixed with rapamycin and dried at the claimed tempera-
ture, 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 re-
sults. “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 copoly-
mer 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 combi-
nation of references suggests utilization of the ’844 Pa-
tent’s copolymer in drug-eluting vascular stents.
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 dis-
sent.