United States Court of Appeals for the Federal Circuit
2008-1073
BOSTON SCIENTIFIC SCIMED, INC.
and BOSTON SCIENTIFIC CORPORATION,
Plaintiffs-Appellees,
v.
CORDIS CORPORATION
and JOHNSON & JOHNSON, INC.,
Defendants-Appellants.
Gregory L. Diskant, Patterson Belknap Webb & Tyler LLP, of New York, New
York, argued for defendants-appellants. With him on the brief were Eugene M.
Gelernter, Michael J. Timmons, Scott B. Howard, and Irena Royzman. Of counsel on
the brief was Constantine L. Trela, Jr., Sidley Austin LLP, of Chicago, Illinois. Of
counsel was Kathleen M. Crotty, Patterson Belknap Webb & Tyler LLP, of New York,
New York.
Charles A. Weiss, Kenyon & Kenyon LLP, of New York, New York, argued for
plaintiffs-appellees. With him on the brief were Richard L. DeLucia, Elizabeth A.
Gardner, and Michael K. Levy.
Appealed from: United States District Court for the District of Delaware
Judge Sue L. Robinson
United States Court of Appeals for the Federal Circuit
2008-1073
BOSTON SCIENTIFIC SCIMED, INC.
and BOSTON SCIENTIFIC CORPORATION,
Plaintiffs-Appellees,
v.
CORDIS CORPORATION
and JOHNSON & JOHNSON, INC.,
Defendants-Appellants.
Appeal from the United States District Court for the District of
Delaware in Case No. 03-CV-283, Judge Sue L. Robinson.
____________________________
DECIDED: January 15, 2009
____________________________
Before LOURIE, RADER, and PROST, Circuit Judges.
LOURIE, Circuit Judge.
Cordis Corporation and Johnson & Johnson, Inc. (collectively “Cordis”) appeal
from the judgment of the United States District Court for the District of Delaware
denying a motion for a new trial and judgment as a matter of law (“JMOL”) following a
jury verdict of infringement of claim 8 of U.S. Patent 6,120,536 (“the ’536 patent”). See
Boston Scientific Scimed, Inc. v. Cordis Corp., No. 03-283-SLR, 2005 U.S. Dist. LEXIS
10735 (D. Del. June 3, 2005) (“Claim Construction Opinion”); Boston Scientific Scimed,
Inc. v. Cordis Corp., 434 F. Supp. 2d 308 (D. Del. 2006) (“Opinion Denying JMOL”);
Boston Scientific Scimed, Inc. v. Cordis Corp., Nos. 03-027-SLR, 03-283-SLR, 2007 WL
2775087 (D. Del. Sept. 24, 2007) (“Opinion Denying New Trial”). Because the court
erred as a matter of law in failing to hold the ’536 patent to have been obvious, we
reverse the judgment.
BACKGROUND
Boston Scientific Scimed, Inc. and Boston Scientific Corporation (collectively
“Boston Scientific”) own the ’536 patent, which relates to a drug-eluting expandable
stent with a coating that has a non-thrombogenic surface. Boston Scientific sued Cordis
in March 2003, alleging, inter alia, that Cordis’s Cypher stent infringed claim 8 of the
’536 patent. Claim 8, the only claim on appeal, depends from claim 6, which depends
from claim 1. Claims 1, 6, and 8 read as follows:
1. A medical device having at least a portion which is implantable into the
body of a patient, wherein at least a part of the device portion is metallic
and at least part of the metallic device portion is covered with a coating for
release of at least one biologically active material, wherein said coating
comprises an undercoat comprising a hydrophobic elastomeric material
incorporating an amount of biologically active material therein for timed
release therefrom, and wherein said coating further comprises a topcoat
which at least partially covers the undercoat, said topcoat comprising a
biostable, non-thrombogenic material which provides long term non-
thromobogenicity to the device portion during and after release of the
biologically active material, and wherein said topcoat is substantially free
of an elutable material.
6. The device of claim 1 wherein the medical device is an expandable
stent.
8. The device of claim 6 wherein the stent comprises a tubular body
having open ends and an open lattice sidewall structure and wherein the
coating conforms to said sidewall structure in a manner that preserves
said open lattice.
’536 patent col.13 l.13–col.14 l.4 (filed June 13, 1996).
2008-1073 2
In June 2005, the district court construed certain limitations of claim 8. The court
held that the phrase “non-thrombogenic material which provides long term non-
thrombogenicity to the device portion during and after release of the biologically active
material” in claim 1 means “a material that does not promote thrombosis for a period of
time that extends both during and after release of the biologically active material.”
Claim Construction Opinion, 2005 U.S. Dist. LEXIS 10735, at *3. The court relied on
medical dictionary definitions for the meaning of “thrombogenic” (“causing thrombosis or
coagulation of the blood”) and “thrombolytic” (“break[ing] up or dissolv[ing] a thrombus”),
“thrombolytic” being a term the patentee used in the specification, but not the claims.
Id. at *3 n.6. The court rejected Cordis’s proposed definition of “non-thrombogenic,”
which required a “significant reduction in thrombogenicity over that experienced with
bare metal stents.” Id. at *4 n.7. The court also construed the phrase “substantially free
of an elutable material” to mean “largely or approximately free of an elutable material.”
Id. at *4.
Cordis makes the Cypher drug-eluting expandable stent. The Cypher stent has
two coatings: an undercoat containing the drug and a topcoat. Early in the
manufacturing process, the Cypher stent’s topcoat is drug-free. The topcoat is sprayed
on as a solution containing no drug but containing a polymer and two solvents,
tetrahydrofuran (or THF) and toluene, both of which are toxic to humans. The solvents
dissolve the drug, allowing it to diffuse from the undercoat into the topcoat. Thus, when
the Cypher stent is sterilized, removing any remaining solvent, the drug has moved into
the topcoat to such an extent that the topcoat and undercoat contain the same
2008-1073 3
concentration of drug. The topcoat is thinner than the undercoat; it contains about 23%
of the total amount of the drug in the stent after sterilization.
At trial, the jury found that claim 8 of the ’536 patent would not have been
obvious based on, among other prior art references, U.S. Patent 5,545,208 (“Wolff”) and
U.S. Patent 5,512,055 (“Domb”). The jury also found that the Cypher stent infringed
claim 8. After trial, Cordis filed a renewed motion for JMOL or, in the alternative, a new
trial on infringement and validity. The court denied Cordis’s motion.
In doing so, the district court upheld the jury’s nonobviousness finding over
Domb, Wolff, and several other references. The court reasoned that Domb, which
discloses esophageal stents, does not suggest the use of metal in a stent, and that
there was no evidence of motivation to combine Domb with other references. Opinion
Denying JMOL, 434 F. Supp. 2d at 320. The court reasoned that Wolff, according to
one expert, does not teach a metallic stent having a two-layer coating, and the failure of
Wolff’s assignee to create the claimed stent after more than a decade of work
evidenced a lack of motivation to combine the features of its various prior art stents with
each other. Id. Finally, as a secondary consideration of nonobviousness, the court
found from expert testimony that the praise for and commercial success of the Cypher
stent were due to the claimed features and that, even after identifying an appropriate
drug and stent, it took Cordis a great deal of time to develop a drug-eluting stent. Id. at
321.
Regarding infringement, the district court reasoned that the jury’s infringement
finding was based on substantial evidence because three experts had testified that
Cypher was non-thrombogenic. Id. at 316–17. As for the “substantially free” limitation,
2008-1073 4
the court found support for the jury’s infringement finding in a witness’s testimony that
the topcoat is drug-free when applied and “has about 1 to 2% drug . . . after
manufacturing is completed,” finding that 1 to 2% drug may be considered “substantially
free.” Id. at 315. The court also pointed to evidence that a stent need not be sterilized
to be implantable and thus that the stent could infringe during manufacture, when the
topcoat was first applied and was then drug-free. Id. The court referred to testimony
that concluded, after applying the court’s claim construction, that the Cypher stent was
substantially free of elutable material. Id. Finally, the court found that the ’536 patent
specifically contemplates that the drug will move into the topcoat prior to implantation,
implying that the “substantially free” limitation does not preclude the topcoat from
containing 23% of the drug. Id. The court thus held that the jury’s finding of
infringement was based on substantial evidence.
After the district court denied Cordis’s motions, Cordis again moved for a new
trial, based on newly discovered evidence that the FDA had found an increased risk of
thrombosis in patients who had been treated with drug-eluting stents. Thus, according
to Cordis, the Cypher stent could not “provide[] long term non-thrombogenicity.” ’536
patent col.13 ll.23–24. The court denied Cordis’s second motion for a new trial because
the FDA had opined that an increased risk of death and heart attack was only possibly
due to stent thrombosis, and thus that the new evidence was too speculative to warrant
either dismissal or a new trial. Opinion Denying New Trial, 2007 WL 2775087, at *3.
Cordis timely appealed the district court’s claim construction, the denial of JMOL
on both obviousness and noninfringement, and the denial of a new trial. We have
jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).
2008-1073 5
DISCUSSION
A. Claim Construction
1. Construction of “Non-Thrombogenic”
Cordis asserts that the district court erred by declining to construe the “non-
thrombogenic” limitation to require less thrombogenicity than an uncoated metal stent.
Cordis argues that, according to the language of claim 8, the specification, and the
prosecution history, the non-thrombogenic material must have an effect different from
the stent’s natural effect, and that the specification itself compares the invention to
metal stents. Also, according to Cordis, Boston Scientific admits that “non-
thrombogenic” is a relative term requiring a comparison, and it waived any argument
that the comparison should be to rough, porous coatings as opposed to bare metal
stents. Cordis also argues that the court should not have relied on dictionary
definitions, especially of unclaimed terms. Cordis asserts that undisputed evidence
showed that Cypher stents and bare-metal stents were equally thrombogenic, such that
Cypher stents would not infringe under the correct claim construction. Although Cordis
publicly declared that its stents were non-thrombogenic, seemingly meeting the claim
language and thus infringing, Cordis argues that its public statements used the term in a
different sense from the patent and that its stents do not infringe.
Boston Scientific responds that nothing in the specification or prosecution history
requires a comparison with bare metal stents; any comparison is to other coatings that
promote thrombosis, so even if the Cypher stent were more thrombogenic than a bare
metal stent, it would still infringe. Indeed, Boston Scientific points out that the claim
language allows some metal to be left uncoated, so that a comparison to bare metal
2008-1073 6
stents would not make sense. According to Boston Scientific, the court’s definition
conforms with both the ordinary meaning and experts’ definitions of “non-thrombogenic.”
Boston Scientific adds that the Cypher stent infringes claim 8 of the ’536 patent under
either the district court’s claim construction or Cordis’s proposed claim construction.
Boston Scientific notes that Cordis admitted in FDA submissions and promotional
literature that the Cypher coating is “non-thrombogenic.” Boston Scientific also points
out that Cordis uses toluene to smooth the surface and remove pores, preventing
thrombosis, indicating that its stents are non-thrombogenic. Finally, according to
Boston Scientific, a new claim construction would require a remand to allow Boston
Scientific to present a new infringement case.
We review claim construction de novo on appeal. Cybor Corp. v. FAS Techs.,
Inc., 138 F.3d 1448, 1456 (Fed. Cir. 1998) (en banc). We agree with Boston Scientific
that the district court reasonably construed the “non-thrombogenic” limitation to mean “a
material that does not promote thrombosis for a period of time that extends both during
and after release of the biologically active material.” To determine the meaning of “non-
thrombogenic,” we begin by considering the language of the claims. See Phillips v.
AWH Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en banc). The language of claim 1
requires that the non-thrombogenic topcoat material “provide[] . . . non-thrombogenicity”
to the stent, but it does not require a comparison to any other stent, either bare metal or
coated. ’536 patent col.13 ll.22–26. As the claims themselves provide no other insight
into the meaning of “non-thrombogenic,” we turn to the specification in order to
determine if it provides a clearer indication of the scope of “non-thrombogenic.”
2008-1073 7
“[C]laims must be read in view of the specification, of which they are a part.”
Phillips, 415 F.3d at 1315 (quotation marks omitted). The abstract of the invention
states that the “non-thrombogenic surface . . . is provided with sites . . . which aid in . . .
reduc[ing] thrombogenic activity.” ’536 patent abstract; see also id. at col.2 ll.36–46
(using heparin “to impart a non-thrombogenic surface to the material”). Thus, we can
discern that the non-thrombogenic material must reduce thrombogenic activity because
of its particular properties. This conclusion accords with the fact that stents are known
to promote thrombosis, and the goal of the patent is to have the claimed stent promote
thrombosis as little as possible, or not promote thrombosis at all. However, it is clear
from the specification that the reduced thrombogenic activity is not necessarily reduced
from that of bare metal stents. Indeed, the specification discusses various ways of
formulating a topcoat and then states that “a top coat or surface coating modified . . . to
make the surface more non-thrombogenic presents a distinct advantage.” Id. at col.6
ll.49–55. Thus, the reduced thrombogenic activity is clearly reduced from that of other
coated stents whose topcoats have not been so modified.
Cordis argues that the prosecution history precludes the district court’s
construction of “non-thrombogenic” and that the claimed device must have had a
reduced risk of thrombosis over that of a bare metal stent. “[A] court should also
consider the patent’s prosecution history, if it is in evidence. . . . Like the specification,
the prosecution history provides evidence of how the [Patent Office] and the inventor
understood the patent.” Phillips, 415 F.3d at 1317 (citations and quotation marks
omitted). During prosecution, the applicant added the “non-thrombogenic” limitation to
overcome an anticipation rejection, explaining that the topcoat “renders the coated
2008-1073 8
device non-thrombogenic” and arguing that the prior art did not provide the same
benefit. However, the prior art device, according to the applicant, was directed to “drug
containing coatings . . . for metal stents.” Parties’ Joint App. at A482 (prosecution
history of ’536 patent, amendment dated July 30, 1997). Thus, if the amendment
required reduced thrombogenicity over anything, it would be reduced over the prior art
stent that is coated, not the bare metal prior art stent. The applicant therefore could not
have considered “non-thromobogenic” to require reduced thrombogenicity over a bare
metal stent.
Cordis also argues that the district court should not have compared dictionary
definitions of “thrombogenic” and “thrombolytic” because “thrombolytic” does not appear
in the claim, and because it is treated synonymously with “non-thrombogenic” in the
specification. We disagree. Courts may of course “rely on dictionary definitions when
construing claim terms, so long as the dictionary definition does not contradict any
definition found in or ascertained by a reading of the patent documents,” Phillips, 415
F.3d at 1322–23, and the court here did not err in relying on dictionary definitions to
inform the meaning of the claim terms. The district court here permissibly looked to the
definitions of “thrombogenic” and “thrombolytic” to inform the meaning of “non-
thrombogenic.” Because the court’s definition accords with the specification,
prosecution history, and the dictionary definition of a related term, we affirm the district
court’s definition of the term “non-thrombogenic.” We therefore need not address
Cordis’s arguments that, under a different claim construction, the Cypher stent does not
infringe claim 8 of the ’536 patent.
2008-1073 9
2. Construction of “Long Term”
Cordis also argues that the district court erred by construing “long term” to mean
a “period of time” and abused its discretion in denying Cordis’s motion for a new trial
based on newly discovered data. According to Cordis, the district court’s construction
improperly erases the claim requirement of “long term” because the claim requires both
“long term non-thrombogenicity” and that the non-thrombogenicity be provided “during
and after release of the biologically active material,” whereas the court’s definition only
required “a period of time that extends both during and after release of the biologically
active material.” Cordis argues that the court’s claim construction lessened the
significance of what the specification describes as an important objective of the
invention. Moreover, according to Cordis, data that became available after the trial but
before entry of judgment showed that its Cypher stent had long-term thrombosis risks,
and Boston Scientific itself publicly stated that the Cypher stent had a higher incidence
of late thrombosis than bare metal stents.
Boston Scientific responds that the “long term” requirement has not been read
out of the claim because the district court’s construction includes a time limitation.
Neither the specification nor the prosecution history limits “long term” to the
phenomenon of late stent thrombosis, which occurs more than one year after
implantation. Moreover, according to Boston Scientific, Cordis has publicly stated that
the same data it now relies on is flawed. Boston Scientific also argues that the data
Cordis seeks to include is cumulative and existed before trial, so it is not new evidence.
We agree with Boston Scientific that the district court correctly construed the
“long term” aspect of the “non-thrombogenic” limitation. Neither the specification nor the
2008-1073 10
prosecution history defines the period of time that is “long term,” other than to require
that it be longer than two weeks, ’536 patent col.7 ll.1–5, and the claim construction
includes two time limitations, like the claim itself. The claim construction requires both
“a period of time” and that the period “extends both during and after release of the
biologically active material.” Even assuming, as Cordis argues, that the specification
describes long-term non-thrombogenicity as an important objective of the invention, it
does not further elucidate the meaning of “long term” or require that those specific
words be used in the claim construction. We thus affirm the district court’s construction
of the “non-thrombogenic” limitation, including the “long term” aspect.
B. Validity
We next turn to the issue of the validity of the ’536 patent. Cordis argues that the
district court erred in denying Cordis’s motion for JMOL of invalidity of the ’536 patent
on the ground of obviousness. According to Cordis, the Wolff patent alone renders the
invention of claim 8 obvious. Figure 3B of Wolff shows a polymer stent made of a drug-
eluting polymer with a barrier topcoat, and Wolff also refers to the stent and topcoat as
separate “layers.” Figure 4 of Wolff then shows a metallic stent with a drug-eluting
polymer coating, and the drug-eluting polymer coating is identified with the same
numeral as the drug-eluting polymer stent of figure 3B. Cordis argues that it would have
been obvious to combine Wolff’s figure 3B, disclosing a drug-eluting polymer stent with
a drug-free coat with the possibility of additional coats, and figure 4, disclosing a metal
stent with a drug-eluting polymer coat, to arrive at the invention of claim 8. In figures 3B
and 4, as shown in the drawing from Cordis’s brief reproduced below, numeral 22 refers
2008-1073 11
to a metal stent, numeral 14 refers to a drug-eluting polymer layer, and numeral 15
refers to a separate layer of polymer that may be drug-free.
Principal Br. of Cordis at 56.
Cordis also argues that Domb alone also renders claim 8 obvious because Domb
teaches every limitation except that the stent can be made of metal and have an open
lattice. However, according to Cordis, both features were well known in the esophageal
stent field of Domb. Cordis adds that at least four other references teach implantable
devices with two-layer coatings that include a polymer undercoat containing a drug and
a barrier topcoat that controls the drug’s release rate. Combined, according to Cordis,
they also disclose every other limitation. Finally, Cordis argues that witnesses
described developing Cypher before the ’536 patent’s priority date and described the
ease, at the time, of coating stents with the two claimed coats. Cordis argues that, in a
pre-KSR–type analysis, Boston Scientific’s expert relied on an unduly low skill level in
asserting that the prior art did not explicitly suggest the modifications that led to the
claimed invention. See KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727 (2007).
Regarding secondary considerations of nonobviousness, Cordis argues that Boston
Scientific failed to link Cypher’s success to the polymer coating.
Boston Scientific responds that Wolff fails to recognize the additional non-
thrombogenic benefits of a topcoat that is substantially drug-free over a topcoat that
2008-1073 12
contains drug, therefore not rendering claim 8 with its non-thrombogenic drug-free
topcoat obvious. Boston Scientific also argues that Wolff only discloses a single coating
layer, and Wolff does not disclose non-thrombogenicity. Although Wolff discloses
silicone and polyurethane as topcoat materials, Boston Scientific asserts that non-
thrombogenicity is not inherent in those materials because non-thrombogenicity
depends on surface properties such as porousness. Boston Scientific adds that Cordis
contradicted its own noninfringement argument about non-thrombogenicity, so the jury
logically could have rejected both positions. Boston Scientific also argues that Domb
does not disclose a non-thrombogenic topcoat, as the stent in Domb was designed to
be used in the esophagus, where there is no circulating blood to cause thrombosis.
According to Boston Scientific, Domb also does not teach metallic or expandable stents.
Boston Scientific further argues that Domb teaches away from an open lattice structure
because an open lattice promotes tissue in-growth, while the Domb stents were
designed to be removable.
Boston Scientific argues that KSR is irrelevant to this obviousness inquiry
because Cordis urged no particular combination of references. As a secondary
consideration of nonobviousness, Boston Scientific argues that Wolff and two of the
other references asserted by Cordis were assigned to Medtronic, who failed to develop
a drug-eluting stent before the priority date of the ’536 patent. Had it been so obvious,
Boston Scientific argues, Medtronic would have made the claimed invention. Also,
according to Boston Scientific, Cordis’s expert admitted to the long-felt need to deliver
drugs from stents. Finally, Boston Scientific argues that Cordis’s witness stated that the
success of the Cypher stent was due to the claimed polymer coating system.
2008-1073 13
We agree with Cordis that Wolff alone renders claim 8 of the ’536 patent obvious
and therefore invalid. Because we hold the claim obvious based on Wolff alone, we do
not address Cordis’s arguments for obviousness based on Domb or any other
reference.
“We review the jury’s conclusions on obviousness, a question of law, without
deference, and the underlying findings of fact, whether explicit or implicit within the
verdict, for substantial evidence.” Johns Hopkins Univ. v. Datascope Corp., 543 F.3d
1342, 1345 (Fed. Cir. 2008) (quotation marks omitted). While a jury may render a
decision on a question of obviousness when it is considering any underlying fact
questions, see id., obviousness is ultimately a question of law that this court reviews de
novo. When we consider that, even in light of a jury’s findings of fact, the references
demonstrate an invention to have been obvious, we may reverse its obviousness
determination. See Richardson-Vicks, Inc. v. Upjohn Co., 122 F.3d 1476, 1479 (Fed.
Cir. 1997) (“[I]n re-creating the facts as they may have been found by the jury, and in
applying the Graham factors to the case, we assess the record evidence in the light
most favorable to the verdict winner . . . , though this does not mean that we are free to
abdicate our role as the ultimate decision maker on the question of obviousness. That
decision remains within our province.” (citation omitted)). That is the case here.
As we have discussed above, claim 8 recites a metallic stent with an open lattice
structure. The stent includes an undercoat and a topcoat. The undercoat contains a
drug, and the topcoat is drug-free and non-thrombogenic. Boston Scientific admits that
Wolff contains most of the limitations of claim 8. Wolff discloses a metallic stent with an
open lattice structure. In figures 2 and 4, where figure 4 is an enlargement of the
2008-1073 14
embodiment shown in figure 2, Wolff col.2 ll.53–54, Wolff discloses a metallic stent, id.
at col.6 ll.57–61, with an open lattice structure, id. at Fig. 2.
Wolff also discloses a stent including an undercoat and a topcoat, where the
undercoat contains a drug. In figure 3B, there is shown a “layer 14,” id. at col.9 l.32,
made of polymer, id. at col.9 l.28, covered by a “second layer of polymer 15,” id. at col.9
l.26. Moreover, the specification describes that the stent shown in figure 3B “may be
made from one or several layers of polymer.” Id. at col.9 ll.23–24 (emphasis added).
Thus, even though figure 3B shows only two layers of polymer, the stent itself and a
single coating, the specification clearly contemplates the use of several, or more than
two, layers of polymer, meaning it contemplates at least two coatings. Wolff also
discloses that the topcoat is drug-free, as layer 15 in figure 3B “may be a simple barrier
which limits diffusion of drugs” and “could be as simple as a silicone or polyurethane.”
Id. at col.9 ll.26–33.
Wolff also discloses that the topcoat is non-thrombogenic. In figure 3B, the
“barrier coating 15 could be as simple as a silicone or polyurethane,” id. at col.9 ll.32–
33, two materials that are generally non-thrombogenic. Even if, as Boston Scientific
contends, silicone and polyurethane are not inherently non-thrombogenic, Wolff clearly
contemplates that the topcoat will be non-thrombogenic. For example, as Wolff
explains, “[t]he initial deposition of platelets and subsequent thrombus formation 38 is
controlled and minimized by the stent design and the elution which limits platelet
aggregation and other immediate repair responses described previously. Localized
thrombus formations . . . [are] also decreased.” Id. at col.9 ll.46–52 (emphases added).
In other words, Wolff contemplates using the design of the stent, which may contain a
2008-1073 15
silicone or polyurethane topcoat, to reduce thrombogenesis, in addition to using the
elution of a thrombolytic drug to reduce thrombogenesis. Thus, the record did not
contain substantial evidence for the jury to conclude that Wolff does not teach a non-
thrombogenic topcoat.
Boston Scientific argues that Wolff fails to recognize the additional non-
thrombogenic benefits of a topcoat that is substantially drug-free over a topcoat that
contains drug, but Wolff need not have recognized the additional benefit of one
embodiment to have rendered the claim obvious. See, e.g., Merck & Co. v. Biocraft
Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (“That the [prior art] patent discloses a
multitude of effective combinations does not render any particular formulation less
obvious. This is especially true because the claimed composition is used for the
identical purpose taught by the prior art.”); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir.
1985) (affirming obviousness rejection of claims in light of prior art teaching that
“hydrated zeolites will work” in detergent formulations, even though “the inventors
selected the zeolites of the claims from among ‘thousands’ of compounds”).
As we have explained, Wolff teaches all of the limitations of claim 8, and the
record did not contain substantial evidence for the jury to conclude otherwise. The only
qualification to this statement of fact is that all of the limitations are found in two
separate embodiments pictured side by side in the patent, not in one embodiment.
However, “[i]f a person of ordinary skill can implement a predictable variation, § 103
likely bars its patentability.” KSR, 127 S. Ct. at 1740. We agree with Cordis that one of
ordinary skill in the art would have been motivated to combine the embodiment in figure
3B of Wolff with the embodiment in figure 4 of Wolff to arrive at a metal stent with two
2008-1073 16
coating layers. Combining two embodiments disclosed adjacent to each other in a prior
art patent does not require a leap of inventiveness. As shown in Cordis’s drawing and
described in the specification of Wolff, figure depicts a metal stent with a drug-eluting
polymer coating, the coating represented by numeral 14. See Wolff col.6 ll.59–62.
Figure 3B, which is located directly below figure 4 in the patent, shows a drug-eluting
polymer stent, also represented by numeral 14, coated with “a second layer of polymer
15.” Id. at col.9 ll.25–26. One of ordinary skill would have been motivated to coat the
metal stent of figure 4, including its layer 14 of drug-containing polymer, with a second
layer of polymer, like layer 15 depicted in figure 3B, that is substantially free of an
elutable material. Just as the stent in figure 3B benefits from the two layers, one
containing a drug and the other limiting diffusion of the drug, so would the stent in figure
4 benefit from the same two coating layers. A metal stent coated with a drug-eluting
polymer and a second layer of drug-free polymer, as shown in figures 3B and 4, is what
constitutes claim 8.
We also agree with Cordis that the weak secondary considerations of
nonobviousness do not overcome the strong prima facie showing that Wolff renders
claim 8 of the ’536 patent obvious. Even though Medtronic owned the Wolff patent and
two other prior art patents that Cordis relies on and failed to develop a drug-eluting
stent, Cordis presented evidence that the failure was due to difficulty in finding a
suitable drug, rather than an inability to conceive of a drug-containing undercoat
combined with a drug-free topcoat. Moreover, “given the strength of the prima facie
obviousness showing, the evidence on secondary considerations was inadequate to
overcome a final conclusion that [the claim] would have been obvious.” Leapfrog
2008-1073 17
Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1162 (Fed. Cir. 2007); see also
Agrizap, Inc. v. Woodstream Corp., 520 F.3d 1337, 1344 (Fed. Cir. 2008) (following
Leapfrog).
The district court thus incorrectly upheld the jury’s verdict of nonobviousness.
“Where . . . the content of the prior art, the scope of the patent claim, and the level of
ordinary skill in the art are not in material dispute, and the obviousness of the claim is
apparent in light of these factors, summary judgment [or JMOL] is appropriate.” KSR,
127 S. Ct. at 1745–46; see Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133,
150 (2000) (“[T]he standard for granting summary judgment mirrors the standard for
judgment as a matter of law, such that the inquiry under each is the same.” (quotations
omitted)). Here, the content of Wolff is not in material dispute. The expert’s testimony
that Wolff “does not teach a metallic stent having a two-layer coating,” Opinion Denying
JMOL, 434 F. Supp. 2d at 320, is undisputed; as we have explained above, we agree
that Wolff does not expressly teach such a stent. However, it teaches two embodiments
that together render such a stent obvious. The scope of claim 8 of the ’536 patent is not
in material dispute, nor is the level of ordinary skill in the art. Although Cordis argues
that Boston Scientific relied on an unduly low level of ordinary skill, the parties agreed at
trial to the level of ordinary skill and did not even present that question to the jury.
Accordingly, we conclude that claim 8 would have been obvious over Wolff at the time
the invention was made. We are free to override the jury’s legal conclusion on the
ultimate question of obviousness without deference. See Muniauction, Inc. v. Thomson
Corp., 532 F.3d 1318, 1324–28 (Fed. Cir. 2008). We therefore hold as a matter of law
that claim 8 would have been obvious in view of Wolff.
2008-1073 18
Because we have reversed the district court’s judgment on validity, Cordis’s
arguments regarding infringement and a new trial need not be considered.
CONCLUSION
Accordingly, the judgment of the district court is reversed.
REVERSED
2008-1073 19
Boston Scientific Scimed, Inc. v. Cordis Corp.
Court: Court of Appeals for the Federal Circuit
Date filed: 2009-01-15
Citations: 554 F.3d 982
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