Boston Scientific Scimed, Inc. v. Cordis Corp.

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.

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 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

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