Petition for Writ of Certiorari — Cordis Corp. v. Boston Scientific Corp (No. 09-365)

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fi) Supreme Con, Us.

09-365 SEP 24 9009

No. 09-

OFFICE OF THE CLES

IN THE

Supreme Court of the United States

CORDIS CORPORATION,

Petitioner,

BOSTON SCIENTIFIC CORP and

BOSTON SCIENT

On PETITION FOR A WE

IFIC SCIMED, INC.,

Respondents.

tIT OF CERTIORARI TO THE

UnN(tTEpD StTaTES Court OF APPEALS

FOR THE FEDERAL CIRCUIT

PETITION FOR A WRIT OF CERTIORARI

Of Counsel:

CONSTANTINE L. TRELA, JR.

SipLeY AUSTIN LLP

One South Dearborn Street

Chicago, IL 60603

(312) 853-7000

GREGORY L. DISKANT

Counsel of Record

EUGENE M. GELERNTER

SEAN MARSHALL

PATTERSON BELKNAP WEBB

& TYLER LLP

1133 Avenue of the Americas

New York, NY 10036

(212) 336-2000

Attorneys for Petitioners

QUESTION PRESENTED

In a patent infringement case, ts it proper to apply the

doctrine of equivalents to cover a product that is outside the

literal scope of the asserted patent claim where the allegedly

equivalent feature was known to persons skilled in the art and

known to the inventor at the time of patenting as a substitute

for a limitation of the patent claim and the inventor could

have drafted and applied for patent claims that cover

products with the allegedly equivalent feature, but did not do

‘$0?

PARTIES TO THE PROCEEDING

Pursuant to Rule 14.1(b), the parties here and in the

proceeding in the U.S. Court of Appeals for the Federal

Circuit are listed.

Petitioner here and appellant in the court below is

Cordis Corporation.

Respondents here and appellees below are Boston

Scientific Corporation and Boston Scientific Scimed, Inc.

RULE 29.6 CORPORATE DISCLOSURE STATEMENT

Johnson & Johnson is the parent company of Cordis

Corporation. Johnson & Johnson is a publicly held

corporation and owns 10 percent or more of the stock of

Cordis Corporation. No other corporation or publicly held

company owns 10 percent or more of the stock of Cordis

Corporation.

ee ee — eR la

TABLE OF CONTENTS

Page

QUESTION PRESENTED des Sada in asAdieh SLEPT ee

PAR CICS FC) THE PROC UIINVGS cisicsccscssvcccetesnassarsesncossses il

RULE 29.6 CORPORATE DISCLOSURE

EPA © ERIE viisekeaynissssicinsdaseesiien amulets nena il

PETITION FOR WRIT OF CERTIORARI ...................0sc0000: ]

eee I es itins eens een 2

Fe a BHI sicsaccsesocscecdsiassigegcasenter ones eee 2

STATUTORY PROVISIONS INVOLVED. ............c0.s00000 Re

STATE OIE C OF Tite Ce cikitinssssststsrcccearncomnnens 3

A. FRPOCAIOOTY TOMNDIIOINE occ cciccssicscessseconcvsscocsiccnseeres 3

B. The Technology at Issue in This Case................. 7

C. The Existing State of Mie Alt...........cccercessscssses coe

D. The Invention that is Described and

CEAIGS OE TG WEE FFI ins cx issn csesassesescsvinsincress 9

Ee. «= FR PE TION soisicivcckseeieecce siesta 12

F. District Court Proceedings...............cccccssessssssesse He

:. SE Diiticsccacccicnceabiivoleausemanace en 12

2 Cordis's Renewed Motion

FE Fes sc ssicscsdencrsavsussiercaeieaunucnue 13

G. Cordis's Appeal to the Federal Circuit............... 13

REASONS FOR GRANTING THE PETITION ................. 15

TABLE OF CONTENTS

(continued)

Page

I. There is a Need for Clarity on When the

DOE Should Apply to Known Substitutes

FOR CI Fe oi idisniss vecevecncsrecseuateisceress ikigeeatnacness 15

1. This Court's Decisions Are in Tension .................60008 17

Pi, FRR CUTS ETE COO I aise cise cscicsscrsessccencens ee

B. PN IIR isos ciidarsckiccsaesssecarss stomata 19

Gy. © PPR as.vanvecdabesinkeecioussoaiumiveresdernin aise viwmcteeniet 20

(11. Federal Circuit Law is Inconsistent ....................0ccc00e 21

A. Cases Holding that the DOE May

Not Be Applied to Cover Substitutes

that the Inventor Knew of, But Did

FG ON sails fends dct ca teaniateesanersaiccaaciencoarss 22

B. Cases Applying the DOE to Structures

that Were Known But Not Claimed .................. 24

C. Resolving these Conflicting Lines of

Authority Would Provide Needed

Clarity to Patentees and the Public.................... 26

IV. This Case is an Excellent Vehicle for Resolving

ON TN oo iret cariscasccakess ueeeneieets Sridicsn can eae aaa 26

Gs Be N avcpeecidcacsecanvencninennsies uchiareuecioseeornepecines sae

INDEX TO APPENDICES

APPENDIX A: Opinion of the U.S. Court

of Appeals for the Federal Circuit, reported at

eo SL ae a Ae. | la

TABLE OF CONTENTS

(continued)

Page

APPENDIX B: Order of the U.S. District

Court for the District of Delaware, filed on

Miay 11, 2006 (UNTO POTted).....6...00:02se0sscececeseeees saadevansauktashane 37a

APPENDIX C: Memorandum Order of the

U.S. District Court for the District of Delaware,

filed on September 24, 2007 (unreported) ................:eeee 39a

APPENDIX D: Opinion of the U.S. District

Court for the District of Delaware, filed on

BF hg re Se Eis ci cnccventcsevecscnvaceanssessvesveeserstesea 47a

APPENDIX E: Order of the U.S. Court of

Appeals for the Federal Circuit denying

rehearing and rehearing en banc, filed

June 26, 2009 (unreported)............... EE.

TABLE OF AUTHORITIES

Page

CASES

Continental Paper Bag Co. v. Eastern

Paper Bag Co., 210 U.S. 405 (1908) ...0. 6, 16

Corning Glass Works v. Sumitomo Elec

U.S.A., Inc., 868 F.2d 1251 (Fed. Cir. 1989)............es000 16

Depuy Spine, Inc. v. Medtronic Sofamor

Danek, Inc., 567 F.3d 1314 (Fed. Cir. 2009) ................. 25

Festo Corp. v. Shoketsu Kinzoku Kogyo

Kabushiki Co., 344 F.3d 1359

(Fed. Cir. 2003)........ pe aniaeraccaly sevvesenes ESE

Festo Corp. v. Shoketsu Kinzoku Kogyo

ee CAS. SSS 6), FAS CAE) crecccescccscveccceness passim

Fiskars, Inc. v. Hunt Mfg. Co.,

221 F.3d 1318 (Fed. Cir. 2000)...... ete ae ee

Freedman Seating Co. vy. American Seating Co.,

420 F.3d 1350 (Fed. Cir. 2005)............c0ss0000089, 13, 14, 23

Fuller v. Yentzer,

NN cli ncs ccs apis shnnsonnsdauananatinneeeieneens 4,18

General Electric Co. v. Wabash Appliance

Cs See Gos SO 8 PUD vavnessinisensdsccsinsenssss 6, 15, 16,17

ee er ee Gis © CETTE cauacesccccticcisicessscreecssacccscnares 4,18

Glaxo Wellcome, Inc. v. Impax Labhs., Inc.,

356 F.3d 1348 (Fed. Cir. 2004) ree 24

Goold v. Rees, 62 U.S. 187 (1872) ..cccccscrccvcccsseccscsesees 4, 17, 19

et — at — , ee = ie ee

TABLE OF AUTHORITIES

(continued)

Page

Graver Tank & Mfg. Co. v. Linde Air

PROS. GH g SIF Cis Cel Ca vi vccesssncecdeccecenscesseessencss 19

Halliburton Oil Well Cementing Co. v

BU Ct 8 BE a cs Sainhcnsosscveonssactioceiincensd 4,19

Interactive Pictures Corp. v. Infinite

Pictures, Inc., 274 F.3d 1371

EPRI, MEI INE Bas iniccscccanasscnadensatptosavensorss leseuacdsnuctuaaaumnce 25

Lifescan, Inc. v. Home Diagnostics, Inc.,

Fe ee Be re Cte BE tdatstetivnxticcse constrict ae

Markman v. Westview Instruments, Inc.,

2 BE Fi ET

McClain v. Ortmayer,

Bee Wee PE CSE DP cess serachcsscevcoveencsice RAR Re AA 16, 17

Merrill v. Yeomans,

OF I css nse cag Cogn sbncdagxanneteuesobeneuariales 7, 50

Overhead Door Corp. v. Chamberlain

Group, Inc., 194 F.3d 1261

ge RE Be RRSP OS AA ROR EE Pa aE re 6, 24, 25

Sage Products, Inc. v. Devon Indus., Inc.,

SSO FF EGEe CE ORs Cae, TIFT) oscsssnscccessssscccscsssvecses passim

United Carbon Co. v. Binney & Smith Co.,

BF ee, ee FEED ioodentntsdavednnesacnntevaccchactsdsicsveorns 6-7, 15

In re Vamco Machine & Tool, Inc.,

Fe ce Ce Cr, 0, ois citskci sens cncenicccecces 16

Warner-Jenkinson Co. v. Hilton-Davis

Chem. Co., 520 U.S. 17 (1997).................... 14, 17, 19, 20

Vil

TABLE OF AUTHORITIES

(continued)

STATUTES

35 U.S.C. § 112,92 2,3, 6, 16

35 U.S.C. § 271 (a) .

28 U.S.C. § 1254(1) 2

IN THE SUPREME COURT OF THE UNITED STATES

CORDIS CORPORATION,

Petitioner,

Vv.

BOSTON SCIENTIFIC CORPORATION AND

BOSTON SCIENTIFIC SCIMED, INC.,

Respondents.

ON PETITION FOR A WRIT OF CERTIORARI

TO THE UNITED STATES COURT OF APPEALS

FOR THE FEDERAL CIRCUIT

Petitioner Cordis Corporation ("Cordis") respectfully

petitions for a writ of certiorari to review the decision of the

U.S. Court of Appeals for the federal Circuit in favor of

Boston Scientific Corp. and Boston Scientific Scimed, Inc.

(collectively, "BSC"), holding that Cordis's BX Velocity and

Cypher stents infringe claim 36 of U S. Patent No. 5,922,021

to David Jang under the doctrine of equivalents. The Federal

Circuit affirmed the district court's judgment of infringement,

and rejected a challenge to the applicability of the doctrine of

equivalents in this case.

OPINIONS BELOW

The opinion of the court of appeals (App., infra, |a-

36a) is reported at 561 F.3d 1319. The order of the court of

appeals denying Petitioner's petition for rehearing and

rehearing en bane (App. 98a-100a) is unreported. The

district court's post-trial orders are at App. 37a-38a and App

39a-46a, and its memorandum opinion is at App. 47a-97a.

JURISDICTION

lhe court of appeals entered judgment on March 31,

2009. App. la. A timely combined petition for rehearing

and rehearing en banc was denied on June 26, 2009. App.

98a-100a. This Court has jurisdiction pursuant to 28 U.S.C.

§ 1254(1).

STATUTORY PROVISIONS INVOLVED

Section 112,92 of the patent statute, 35 U.S.C.

§ 112, { 2, states:

The specification [of a patent] shall conclude

with one or more claims particularly pointing

out and distinctly claiming the subject matter

which the applicant regards as his invention.

Section 271](a) of the patent statute, 35 U.S.C. § 271(a),

states:

Except as otherwise provided in this title,

whoever without authority makes, uses, offers

to sell, or sells any patented invention, within

the United States or imports into the United

States any patented invention during the term

of the patent therefor, infringes the patent

STATEMENT OF THE CASE

A. Introductory Statement

[his case presents an important issue on which this

Court's decisions are in tension and Federal Circuit precedent

is contradictory.

The issue is whether the doctrine of equivalents

("DOE") may be applied in patent cases to cover a product

with a feature that was known at the time of patenting to the

inventor and to other persons skilled in the art as a substitute

for a limitation of the patent's clatms, where the inventor

could have drafted claims that would literally have covered

products with the allegedly equivalent feature, but did not do

so.

This issue is important because, while the patent

statute requires a patent applicant to "distinctly claim[ | the

subject matter which the applicant regards as his invention,"

35 U.S.C. § 112,42, the DOE expands those claims and

creates uncertainty about the scope of patent protection. See

Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535

U.S. 722, 732 (2002). That uncertainty is heightened where,

as here, the law is inconsistent and unclear. In such

circumstances, it becomes all the more "difficult to determine

what ts, or is not, an equivalent to a particular element of an

invention.” /d. This heightened uncertainty can impede

legitimate competition, with unfortunate consequences for

the public. "If competitors cannot be certain about a patent's

extent, they may be deterred from engaging in legitimate

manufactures outside its limits, or they may invest by

mistake in competing products that the patent secures. " /d

At bottom, this case raises a question of great

importance: Where the patentee and those of skill in the art

know that a particular feature not claimed in the patent is

interchangeable with one that the patentee has distinctly

claimed, may the patentee iater in litigation expand the scope

of the patent under the DOE to cncompass that unclaimed

feature, or may the public rely on the fact that the feature is

unclaimed in order to develop useful devices? One answer

grants the patentee greater patent protection than he claimed,

while leaving the public uncertain about the scope of the

patent; the other favors competition and limits the patent's

scope to what the patentee actually described in his claims.

Prior decisions of this Court do not answer this

question. Ln nineteenth century cases and continuing into the

middle of the twentieth century, this Court treated the DOE

as applicable for features that were known at the time of

patenting as interchangeable substitutes for an element that is

described in the patent claim, while explicitly stating that the

DOE is not applicable for substitutes that were unforeseeable

or not known as interchangeable at the time the patent issued.

See, e.g., Gould v. Rees, 82 U.S. 187, 193 (1872); Fuller v.

Yentzer, 94 U.S. 299, 300 (1876); Gill v. Wells, 89 U.S. 1, 13

(1874); Halliburton Oil Well Cementing Co. v. Walker, 329

U.S. 1, 13 (1946).

However, recognizing important changes in the law,

this Court effectively reversed course in its 2002 decision in

Festo, 535 US. 722, and placed the burden of precision in

language on ihe patentee. In Festo, this Court reasoned that

"It]he patentee, as the author of the claim language, may be

expected to draft claims encompassing already known

equivalents." /d at 740; see also id. at 741 ("The patentee

must show that at the time of the amendment one skilled in

the art could not reasonably be expected to have drafted a

claim that would have literally encompassed the alleged

equivalent."). Thus, unlike Gou/d and related cases, Festo

holds that there is no reason to allow the DOE to encompass

interchangeable substitutes known at the time the patent

claim was drafted. Meanwhile, also unlike Gould and related

cases, /esto accepts the proposition that the DOE can be

extended to equivalents that were unforeseeable at the time

of patenting, but that are shown to be equivalent at the time

of infringement. 535 U.S. at 740-41.

Festo addresses only claim clements that were

narrowed by amendment during prosecution of a patent

application. However, its logic applies with equal force for

claim elements that were not amended. For both amended

and un-amended claim elements, "[t}he patentee, as the

author of the claim language, may be expected to draft claims

encompassing already known equivalents." Jd. at 740.

Although this Court has not had occasion to consider

whether Festo's logic applies to unamended claim elements,

the Federal Circuit has developed two contradictory lines of

precedent on the issue.

Consistent with Festo's reasoning, some Federal

Circuit decisions place the onus on the patentee to draft

patent claims that cover alternatives known at the time of

patenting, foreclosing resort to the DOE for such features if

the claims as drafted do not literally cover them. See Sage

Products, Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1425

(Fed. Cir. 1997) ("as between the patentee who had a clear

opportunity to negotiate broader claims but did not do so, and

the public at large, it is the patentee who must bear the cost

of its failure to seek protection for this foreseeable alteration

of its claimed structure."); Freedman Seating Co. v.

American Seating Co., 420 F.3d 1350, 1360-62 (Fed. Cir.

2005).

As these cases recognize, it is reasonable to expect

patentees to draft claims that literally cover known

alternatives if they consider those alternatives to be within

the scope of their invention and want them to be within the

scope of the patent. See Festo, 535 U.S. at 740. This is

especially true where there are no "shortcomings of

language" that would have "prevented [the patentee] from

describing the alleged equivalent when it [drafted] the

claim." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki

Co., 344 F.3d 1359, 1370 (Fed. Cir. 2003).

Other Federal Circuit decisions follow the opposite

approach, based on the earlier cases from this Court. They

place the onus on the public to predict whether an unclaimed

feature that was known at the time of patenting to be

interchangeable with an element of the claim, but that was

not claimed, will later be treated as an equivalent of the claim

element under the DOE. See, e.g, Overhead Door Corp. v.

Chamberlain Group, Inc., 194 F.3d 1261, 1270 (Fed. Cur.

1999); Lifescan, Inc. v. Home Diagnostics, Inc., 76 F.3d 358,

362 (Fed. Cir. 1996).

Resolving the conflicting lines of Federal Circuit

precedent on this issue is a matter of considerable

importance. In our claims-based patent system, "[t]he claims

‘measure the invention." General Electric Co. v. Wabash

Appliance Corp., 304 U.S. 364, 369 (1938), quoting

Continental Paper Bag Co. v. Eastern Paper Bag Co., 210

U.S. 405, 419 (1908). The DOE extends the patent grant

beyond what the inventor has "distinctly claim[ed] [as] the

subject matter ... [of] his invention" under § 112, $2, to

encompass substantial equivalents that are not described in

the patent claims.

As a result, the DOE "renders the scope of patents

less certain," Festo, 535 U.S. at 732, because "[i]t may be

difficult to determine what is, or is not, an equivalent to a

particular element of an invention." /d. This uncertainty can

redound to the public's detriment. "A zone of uncertainty

which enterprise and experimentation may enter only at the

risk of infnngement claims would discourage invention only

a little less than unequivocal foreclosure of the field." United

Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 236

(1942).

This "zone of uncertainty" is enlarged where there are

contradictory lines of precedent on how the DOE should be

applied. Reducing that uncertainty will benefit both the

public and patentees by avoiding unnecessary disputes about

the scope of patent protection while promoting legitimate

competition. See Festo, 535 U.S. at 732; Markman y.

Westview Instruments, Inc., 517 U.S. 370, 390 (1996);

Merrill v. Yeomans, 94 U.S. 568, 573-74 (1876).

B. The Technology at Issue in This Case

The technology in this case involves coronary stents,

which cardiologists use for treating coronary artery disease.

Coronary artery disease involves the narrowing of the

coronary arteries, which restricts or blocks the flow of blood

to the heart. This can lead to serious consequences, including

a heart attack or death.

Stents are small, cylindrical, lattice-like structures.

Generally, they are made of metal. They are implanted in

the coronary arteries to maintain an open passageway in the

artery for the flow of blood.

Unlike open-heart surgery, the implantation of a stent

is a minimally invasive procedure. Typically, the physician

makes a small incision in the patient's groin and then inserts

and delivers the stent on a balloon catheter through the

patient's vascular system to a portion of a coronary artery that

has been narrowed by disease. Once the stent reaches the

desired location in a diseased artery, the physician expands

the balloon on which the stent has been mounted. Expansion

of the balloon expands the stent to a desired diameter. The

balloon is then deflated and withdrawn. The stent stays in

place in the artery and keeps its expanded diameter to

maintain an open passageway for the flow of blood.

_ fe The Existing State of the Art

In this case, BSC has accused Cordis of infringing

U.S. Patent No. 5,922,021 to David Jang (the '"'021 patent").

The '021 patent issued from an application that Dr. Jang filed

with the Patent Office on April 25, 1997. The '021 patent

claims the benefit of the earlier filing date of a provisional

application that he filed on April 26, 1996.

By April 1996, stent technology was a crowded field.

Stents already were standard treatment for coronary artery

disease, and the basic principles of stent design were well

established.

Known stents typically combined two basic building

blocks: (1) zig-zag rings that expand in diameter to keep the

artery open for the flow of blood; and (2) connectors that link

adjacent rings and provide flexibility so that the stent can

readily be delivered through curved arteries. There were

known variations for the zig-zag rings and for the

configuration of the connectors.

In particular, there were two known alternatives for

the shape of the zig-zag rings. They could have angular

corners (as in U.S. Patent No. 5,102,417 to Palmaz) or

semicircular arcs and no comers (as in WO 96/03092 to

Israel et al.).

| |

———/\ —\

/ Ip ——

{3 yee

WO 96/03092

to Israel et al., Fig. 7 |

100

U.S. Patent No. 5,102,417

to Palmaz, Fig. 7

_ a

Whether to use rings with or without corners was a

matter of design choice. Both alternatives were known to the

inventor.

D. The Invention that is Described and

Claimed in the '021 Patent

The specification of the ‘021 patent describes and

depicts various stent designs. All of those embodiments have

zig-zag rings and al! of the zig-zag rings have angular

corners. £.g.:

'021 Patent, Fig. 10D | ‘021 Patent, Fig. 2B

In some embodiments, the corners form right angles.

E.g., ‘021 patent at col. 15, lines 49-55 ("[i]n the design of

FIGS. 10D and 10E" the "[jJoining struts 30 are at right

angles to the expansion struts 28 they connect.") (emphasis

added). In the other embodiments, the corners form acute

and obtuse angles. £.g., ‘021 patent at col. 6, line 66 — col. 7,

line 3 ("Referring now to FIGS. 2A and 2B, joining struts 30

of stent 10 are seen to extend at an angle to the expansion

struts 28, forming a narrow [i.e., acute] angle 48 with one

expansion strut 28 ... and a wide [i.e., obtuse] angle 50 with

the other expansion strut 28 of an expansion strut pair 32.")

(emphasis added).

Although zig-zag rings with circular arcs were known

in the art as an alternative to zig-zag rings with angular

corners, the '02] patent does not describe or depict any

embodiment that has circular arcs instead of corners.

Meanwhile, the patent specification makes clear that

the inventor knew that rings with circular arcs could be used

as a substitute for rings with corners. In the section of the

patent specification entitled "Background of the Invention,"

the inventor cited two examples of “conventional stents" that

were known 1n the art. One of these examples was U.S.

Patent No. 5,102,417, shown on the left below, which had

Zig-zay rings with angular corners. The other example was

WO 96/03092, the so-called "Brun patent,” shown on the

right below, which had zig-zag rings in the shape of circular

arcs with no corners:

Although the inventor was aware that a stent's zig-zag

rings could either have angular corners or circular arcs and

no comers, he viewed corners as desirable and thus chose to

make "comers" an explicit requirement of claim 36.'

Angular corners and circular arcs have different expansion

characteristics and provide different places for attachment of

other stent components. For purposes of his invention, Jang

preferred angular corners. Claim 36 was the only patent

claim that BSC asserted against Cordis in this case. Claim

36 (and claim 23 trom which it depends) requires sixteen

"corners."

Consistent with this Court's decision in Markman,

517 U.S. 370, the district court construed the term "corner"

prior to tral, as meaning the "place where two surfaces meet

to form an angle." \Vhe "corner" limitation, as construed by

the district court, thus describes the stents that are described

and depicted in the specification of the '021 patent, in which

the zig-zag rings have the angular shape of corners. The term

"corner" does not describe the other known alternative — i.e.,

stents in which the zig-zag rings have semicircular arcs and

no corners. Thus, stents without corners, as known in the art,

are not within the literal scope of claims 23 and 36 and do

not literally infringe those claims.

If the inventor had wanted these claims to cover

stents without corners, it would have been casy cnough for

him to have drafted them with that scope. In fact, the

inventor did precisely that for claims 1-22 of the '021 patent.

Claims 1-22 do not include the “corners” limitation, and thus

are broad enough to cover both alternatives that were known

Claim 36 is a dependent claim, that 1s, 1t depends from — and

incorporates the limitations of — claim 23. Claim 23, in turn,

includes explicit claim limitations requiring that zig-zag rings (or

"expansion columns") have expansion struts that are coupled to

joining struts at "corners." See col. 20, lines 5-23 and lines 42-60

in the art, ie, stents with and without corners. Asserted

claim 36, however, 1s drafted in a narrower manner, as

limited to stents with "corners."

E. The Accused Devices

In this case, BSC alleged that Cordis's BX Velocity

and Cypher stents infringe one claim of the '021 patent

claim 36. BSC admits that Cordis's stents do not infringe

other claims of the ‘021 patent, such as claim 1, that lack the

"corners" limitation.

The Cordis stents share the same design, as shown on

the right. Both have zig-zag

rings (or "expansion columns")

made up of "expansion strut

pairs" in which expansion struts

(shown in red) are coupled to

joining struts (shown in blue).

The joining struts have the

shape of semicircular arcs. The

semicircular arcs do not form angular "corners" where they

meet the expansion struts.

KF. District Court Proceedings

F The Trial

In order to prove literal infringement, BSC needed to

show by a preponderance of the evidence that Cordis's stents

have every limitation or requirement of claim 36 under the

district court's claim construction. Thus, BSC needed to

show, inter alia, that the expansion struts in Cordis's stents

are coupled to the joining struts at "corners," /.e., "place[s]

where two surfaces meet to form an angle." The jury found

that BSC failed to make this showing and returned a verdict

that Cordis's stents do not literally infringe claim 36

Although the jury found no literal infringement, it

nonetheless concluded that Cordis's stents infringe the

"corners" limitation under the DOE.

, Fe Cordis's Renewed Motion for JMOL

After the tnal, Cordis renewed its earlier motion for

judgment as a matter of law (JMOL) that its stents do not

infringe the "corners" limitation under the DOE. Cordis

explained, as described above, that stents with and without

corners both were known in the art. Cordis further

demonstrated that the inventor was aware of both types of

stents when he applied for the '021 patent and noncthceless

chose to limit claim 36 to stents with "corners." Under these

circumstances, Cordis argued, the patentee cannot contend

that the claim covers known but unclaimed alternatives under

the DOE.

The district court denied Cordis's motion without

addressing Cordis's argument that the DOE could not be

applied to cover an unclaimed alternative when the inventor

and those in the field were well aware of that alternative at

the time of patenting.

G. Cordis's Appeal to the Federal Circuit

As it had done in the district court, Cordis relied on

Freedman Seating, 420 F.3d at 1360-62, and Sage Products,

126 F.3d at 1425, which hold that where two alternatives are

known in the art and known to the inventor at the time of

patenting, and the inventor nonctheless drafted his claim so

as to limit it to one of those known alternatives, the patentee

cannot later rely on the DOE to cover the other known

alternative. Thus, Cordis argued on appeal that "[w]ith both

types of stents known in the art and known to the inventor,

'{[a] skilled patent drafter would foresee the limiting potential

of the ['corners'] limitation’ and could have drafied a claim

without the "corners" limitation if he ‘desired broad[er] patent

protection.” (quoting Freedman Seating, 420 F.3d at 1360,

which in turn quotes Sage Products, 126 F.3d at 1425).

Cordis argued that "in assessing the bounds of the claim,"

competitors "were 'justified'" in relying on the fact that the

inventor was aware of both alternatives but limited claim 36

to stents with "corners."

The Federal Circuit affirmed the judgment of

infringement under the DOE. In doing so, it did not attempt

to distinguish this case from its contrary decisions in

Freedman Seating, 420 F.3d at 1360-62, and Sage, 126 F.3d

at 1425. It focused instead on a different argument made by

Cordis — that application of the DOE in this case vitiated the

"corners" requirement — and it rejected that argument (A 17a):

Although we have "refused to apply the

doctrine [of equivalents] ... where the accused

device contained the antithesis of the claimed

structure," ... the circular arcs of [Cordis's

stents] are not antithetical to the "corners"

limitation in claim 36 of the '021 patent.

Boston Scientific's theory that the circular arcs

[of Cordis's stents] are equivalent to the

"corners" in claim 36 does not vitiate the

"corners" limitation, because it does not

"render| | the pertinent limitation

meaningless," Freedman Seating Co. v. Am

Seating Co., 420 F.3d 1350, 1359 (Fed. Cir.

2005), or "effectively eliminate that element

in its entirety," Warner-Jenkinson, 520 U.S. at

29.

lhe Federal Circuit did not explain why this case

warrants a result different from Freedman Seating and Sage,

which hold that the DOE is inapplicable in the circumstances

presented here.

REASONS FOR GRANTING THE PETITION

I. There is a Need for Clarity on When the

DOE Should Apply to Known Substitutes for

a Claim Element

More than a century ago, this Court stated that

"nothing can be more just and fair, both to the patentee and to

the public, than that the former should understand, and

correctly describe, just what he has invented and for what he

claims a patent." Merrill v. Yeomans, 94 U.S. 568, 573-74

(1876). Clarity as to "[t]he limits of patent protection" is

important, both "for the protection of the patentee" and to

avoid chilling competitive activities by others. Markman y.

Westview Instruments, Inc., 517 U.S. 370, 390 (1996),

quoting General Electric Co. v. Wabash Appliance Corp.,

304 U.S. 364, 369 (1938).

In particular, there is a strong interest in a clear

demarcation of the boundary that separates the products that

are covered by a particular patent (which may not be used

without the inventor's permission) from those not covered by

the patent (which the public may freely use).

Otherwise, a “zone of uncertainty which

enterprise and experimentation may enter only

at the risk of infringement claims would

discourage invention only a little less than

foreclosure of the field," United Carbon Co. v

Binney & Smith Co., 317 U.S. 228, 236, 63 S.

Ct. 165, 170, 87 L.Ed. 232 (1942), and "[t]he

public [would] be deprived of rights supposed

to belong to it, without being clearly told what

it is that limits these rights." Merrill v

Yeomans, 93 U.S. 568, 573, 24 L.Ed. 235

(1877).

Markman, 517 U.S. at 390. In this regard, "[i]t has long been

understood that a patent must describe the exact scope of an

invention and its manufacture" in order to "secure to [the

patentee] all to which he is entitled, [and] to apprise the

public of what is still open to them." /d at 373, quoting

McClain v. Ortmayer, 141 U.S. 419, 424 (1891).

To provide clarity on these issues, § 112, 42 of the

patent statute, 35 U.S.C. § 112, 42, requires that a patent

conclude with one or more claims, "particularly pointing out

and distinctly claiming the subject matter which the applicant

regards as his invention.” “The claims ‘measure the

invention."" General Electric Co. v. Wabash Appliance Co.,

304 U.S. 364, 369 (1938), quoting Continental Paper Bag

Co. v. Eastern Paper Bag Co., 210 U.S. 405, 419 (1908).

Much as a deed defines the boundaries of real property, /n re

Vamco Machine & Tool, Inc., 752 F.2d 1564, 1577 n.5 (Fed.

Cir. 1985), the claims of a patent define the "metes and

bounds" of the patent's scope. Corning Glass Works v.

Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir.

1989).

The DOE "remain{s] a firmly entrenched part of the

settled rights protected by the patent," Festo Corp. vy.

Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722, 733

(2002), and extends patent protection beyond what the

inventor has "distinctly claim[ed]" as the subject matter of

the invention under § 112,42. In doing so, the DOE "blurs

the line of demarcation between infringing and non-

infringing activity," and "creates a zone of uncertainty” that

may lead to "foreclosure of competitive activity within the

penumbra of each issued patent claim." Sage Prods., Inc. vy.

Devon Indus., Inc., 126 F.3d 1420, 1425 (1997).

As this Court explained in ‘esto, "the doctrine of

equivalents renders the scope of patents less certain" because

"{ift may be difficult to determine what is, or is not, an

equivalent to a particular element of an invention.” 535 U.S.

at 732. And "li]f competitors cannot be certain about a

patent's extent, they may be deterred from engaging in

legitimate manufactures outside its limits, or they may invest

by mistake in competing products that the patent secures."

Id.; see also Warner-Jenkinson, 520 U.S. at 29 ("There can

be no denying that the doctrine of equivalents, when applied

broadly, conflicts with the definitional and public-notice

functions of the statutory claiming requirement.").

The potential for conflict between the DOE and the

"definitional and public-notice functions of the statutory

claiming requirement," id., 520 U.S. at 29, becomes all the

more acute where, as here, there are contradictory lincs of

precedent. The existence of contradictory Federal Circuit

cases some holding that the DOE is inapplicable to

structures that were known at the time of patenting as

substitutes for the patented invention, and others reaching the

opposite result — impedes the public's ability to determine

whether a known interchangeable feature is available for use

without restriction or will be treated as an equivalent under

the DOE. There is a strong interest in minimizing this zone

of uncertainty. Markman, 517 U.S. at 390; General Electric,

304 U.S. at 369; McClain, 141 U.S. at 424.

II. This Court's Decisions Are in Tension

A. This Court's Early Cases

More than a century ago, in Gould v. Rees, 82 U.S.

187 (1872), this Court drew a sharp distinction for purposes

of the DOE between interchangeable substitutes known at the

time of patenting and those that were not known as

interchangeable at the time of patenting. /nder the approach

sct forth in Gould, the DOE applics in the former situation

and is inapplicable in the latter

Thus, Gould stated that the DOE is applicable where

the alleged equivalent was "well known at the date of the

patent as a proper substitute for the [feature described in the

claim] ...." /d. at 194 (emphasis added). Conversely, Gould

stated that the DOE is not applicable where "the ingredient

substituted for the [ingredient described in the claim] was a

newly discovered one, or even an old one performing some

new function, and was not known at the date of the plaintiff's

patent, as a proper substitute for the ingredient withdrawn

...."" Id. at 193 (emphasis added).

Other decisions took the same approach. In Gill v.

Wells, 89 U.S. 1 (1874), this Court stated:

[[]t is clear law that the substituted ingredient

cannot be regarded as a legal equivalent,

within the meaning of the Patent law, unless it

performs substantially the same function as

the ingredient withdrawn, and was well known

as such an ingredient at the date of the

original patent and as a proper substitute tor

the ingredient which was included in the

patented combination.

/d. at 30 (emphasis added): see also Fuller v. Yentzer, 94

U.S. 299, 300 (1876) ("Modifications or alterations in an

invention consisting in @ combination of old ingredients,

which merely substitutes another old ingredient for one of the

ingredients in the patented combination, is an infringement of

the patent, if the substitute performs the same function and

was well known at the date of the patent as a proper

substitute tor the one omitted from the patented invention;

but the rule is otherwise if the ingredient substituted is a new

one, or performs a substantially different function, or was not

known at the date of the patent as a proper substitute for the

one omitted from the patent.") (emphasis added),

Halliburton Oil Well Cementing Co. v. Walker, 329

U.S. 1 (1946), followed the same approach when it stated

that a party accused of infringement can defeat an allegation

of infringement under the DOE by showing that the feature

of the allegedly infringing device was "not known at the date

of ... [the patent] as a proper substitute for the [claimed

feature]" or was "actually invented after the date of the

patent." /d. at 13.

Likewise, Graver Tank & Mfg. Co. v. Linde Air

Prods. Co., 339 U.S. 605 (1950), implicitly accepted the rule

of the nineteenth century cases. It described known

interchangeability as an "important factor" for application of

the DOE:

An important factor is whether persons

reasonably skilled in the art would have

known of the interchangeability of an

ingredient not contained in the patent with one

that was.

Id. at 609. On the facts before it, Graver Tank upheld the

application of the DOE in view of evidence of "disclosures of

the prior art {that} made clear that manganese silicate was a

useful ingredient in welding compositions." /d. at 612.

B. Warner-Jenkinson

Warner-Jenkinson Co. v. Hilton-Davis Chem. Co.,

520 U.S. 17 (1997), was the first step in changing the

analysis. This Court reaffirmed that "knowledge of the

interchangeability between claimed and accused elements” is

relevant in a DOE analysis "for what it tells the fact-finder

about the similarities or differences between those elements."

Id. at 37, citing Graver Tank, 339 US. at 609.

Whereas earlier cases had held that the DOE is not

available for equivalents that become known after the patent

issued, Warner-Jenkinson held that "the proper time for

evaluating equivalency - and thus’ knowledge of

interchangeability between elements — is at the time of

infringement, not at the time the patent was issued." 520

U.S. at 37. Implicit in this analysis is an expansion of the

scope of equivalents from this Court’s earlier cases. The

earlier cases limited the DOE to features that were known to

be interchangeable at the time of patenting. A fortiori, those

features will (at least ordinarily) also be known to be

interchangeable at the time of infringement.

cc Festo

Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki

Co., 535 U.S. 722 (2002), represents a fundamental shift in

thinking on the DOE, away from the approach followed in

earlier cases.

Festo teased apart the two time periods implicitly

embraced by Warner-Jenkinson, and reversed the nineteenth

century mode of analyzing each period. Thus, it affirms the

propriety under Warner-Jenkinson of basing a finding of

equivalence on an interchangeable feature developed after

the invention and not foreseeable to the patentee. But it calls

into question the earlier rule permitting a patentee to forego

claiming a known equivalent and later to assert the patent

against a third-party who utilizes that known, and unclaimed,

equivalent.

Festo addresses situations in which the DOE is

asserted for a claim element that was narrowed by an

amendment during patent prosecution. The Federal Circuit

had held that there is an absolute bar against asserting the

DOE for claim elements that are so amended. In Festo, this

Court rejected an "absolute bar" in favor of a more flexible

approach that treats such amendments as presumptively

barring the application of the DOE. This Court held that a

patentee can Overcome the presumption by demonstrating,

inter alia, that the alleged equivalent was unforeseeable at

the time the amended claim language was submitted to the

Patent Office. To come within the scope of this

"unforeseeability" exception, "[t]he patentee must show that

at the time of the amendment one skilled in the art could not

reasonably be expected to have drafted a claim that would

have literally encompassed the alleged equivalent." Jd. at

741 (emphasis added). This approach is reasonable because

"[t]he patentee, as the author of the claim language, may be

expected to draft claims encompassing readily known

equivalents." Id. at 740 (emphasis added).

Although Festo by its terms applies only to claim

elements that were narrowed by an amendment during patent

prosecution, its logic is equally applicable to all claim

limitations. For all claim limitations, it is _ perfectly

reasonable to expect the patentee "to draft claims

encompassing readily known equivalents," id., if the patentee

considered them to be within "the subject matter of the

invention." Any other result would have the perverse effect

of foreclosing the application of the DOE for equivalents that

were known as interchangeable when a claim limitation was

amended, while leaving the DOE fully available for

equivalents that were known as interchangeable at the time a

claim was originally drafted. No logic or policy supports any

such distinction.

il. Federal Circuit Law is Inconsistent

The tension in this Court's decisions is mirrored in

two strands of Federal Circuit cases that reach inconsistent

results on this issue. Supreme Court review would help in

bringing clarity to this important issue.

A. Cases Holding that the DOE May Not

Be Applied to Cover Substitutes that

the Inventor Knew of, But Did Not

Claim

In some cases, both before and after Festo, the

Federal Circuit has held that where the inventor chose to

limit his claims to only one of two or more structures known

at the time as interchangeable, then the public may justifiably

rely on that choice in assessing the scope of patent

protection. Under the reasoning of these cases, the patentee

may not subsequently assert that other structures that were

known at the time as interchangeable, which the inventor was

aware of but chose not to claim, are within the scope of the

patent under the DOE.

For example, in Sage, 126 F.3d at 1425, the Federal

Circuit explained that where substitutes are known in the art

and known to the inventor at the time of patenting, "[a]

skilled patent drafter would foresee the limiting potential" of

drafting claims that are limited to only one of those known

substitutes. In such circumstances, "[n]o subtlety of

language or complexity of the technology, nor any

subsequent change in the state of the art, such as later-

developed technology, obfuscate[s} the significance of this

limitation at the time of its incorporation into the claim."

Thus, where more than one alternative design is

known in the art, nothing prevents an inventor from applying

for a patent that covers both known alternatives — if a patent

with that scope is desired: "If Sage desired broad patent

protection for any container that performed a function similar

to its claimed container, it could have sought claims with

fewer structural encumbrances." /d. If an inventor applies

for a patent that covers known alternatives, the Patent Office

then has the opportunity to "fulfill[ ] its statutory role in

helping to ensure that exclusive nghts issue only to those

who have, in fact, contributed something new, useful, and

unobvious." /d.

The Federal Circuit reasoned in Sage that inventors

who choose not to apply for a patent that covers a known

alternative should not be able to seck that scope of patent

protection in a later infringement suit (id. ):

Instead [of applying for a patent that would

cover known alternatives], Sage left the PTO

with manifestly limited claims that it now

seeks to expand through the doctrine of

equivalents. However, as between the patentee

who had a clear opportunity to negotiate

broader claims but did not do so, and the

public at large, it is the patentee who must

bear the cost of its failure to seek protection

for this foreseeable alteration of its claimed

structure.

Freedman Seating, 420 F.3d at 1362, applies the

same reasoning:

The patentees ... stated that they were aware

of other types of four bar mechanisms.

Yet, they chose to specifically limit the claims

to slider-crank mechanisms vis-a-vis the

"slidably mounted" moveable end limitation.

Members of the public were therefore justified

in relying on this specific language in

assessing the bounds of the claim.

Accordingly, we think that to now say the

claims include other four bar mechanisms

under the doctrine of equivalents would

unjustly undermine the reasonable

expectations of the public.

More recently, in Glaxo Wellcome, Inc. v. Impax

Labs., Inc., 356 F.3d 1348 (Fed. Cir. 2004), a post-Festo

opinion, the Federal Circuit rejected the view that Festo's

holding should be limited to the failure to include known

equivalents when making a narrowing amendment. "[R]ead

in context, the Supreme Court in Festo neither excuses an

applicant from failing to claim 'readily known equivalents’ at

the time of application nor allows a patentee to rebut the

Festo presumption by invoking its own failure to include a

known equivalent in its original disclosure. Instead, the

critical inquiry is whether [the patentee] could have foreseen

sustained release agents for bupropion other than HPMC at

the time of filing or amendment." Id. at 1355 (emphasis

added).

B. Cases Applying the DOE to Structures

that Were Known But Not Claimed

Other Federal Circuit cases, both before and after

Festo, have taken the opposite approach. In these cases, the

Federal Circuit has applied the DOE where the

interchangeability of the alleged equivalent and the claim

element was known at the time of time of patenting and

nothing picvented the patentee from claiming the equivalent,

if that had been intended.

For example, the Federal Circuit retied on "known

interchangeability" in Overhead Door Corp. v. Chamberlain

Group, Inc., 194 F.3d 1261(Fed. Cir. 1999), in reversing a

grant of summary judgement of noninfringement under the

DOE. In that case, the patent claim included a limitation

requiring a mechanical "memory selection switch." The

device that was alleged to infringe did not have a mechanical

switch as called for by the patent claim, and instead

"select{ed] memory locations with a software program, not

with a mechanical switch." /d at 1269. In reversing the

grant of summary judgment of noninfringement, the Federal

Circuit stated that the art had long recognized software

processes and hardware processes "“as_ interchangeable

substitutes" and the decision of which to use was a "matter of

design choice." /d. at 1269-70.

Likewise, in Lifescan, Inc. v. Home Diagnostics, Inc.,

76 F.3d 358 (Fed. Cir. 1996), the Federal Circuit remanded

for further proceedings under the DOE, based evidence that

the alleged infringer had "simply replaced the initial step of

the [patented] process with a known _ interchangeable

alternative" that was taught by the prior art. /d. at 362. It

stated that the evidence that the "known interchangeable

alternative” was taught by prior art pre-dating the patent

could be viewed as "reinforcing [the patentee's] position that

the processes are equivalent.” /d.

Just this year, the Federal Circuit relied on "evidence

tending to show that conical and spherical surfaces are

interchangeable" in assessing the objective reasonableness of

the plaintiffs assertion of infringement under the DOE.

Depuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567

F.3d 1314, 1336 (Fed. Cir. 2009). The evidence

demonstrated that this interchangeability was known before

filing of the patent-in-suit. Jd. at 1337; see also Interactive

Pictures Corp. v. Infinite Pictures, Inc., 274 F.3d 1371, 1383

(Fed. Cir. 2001) ("testimony that the claimed [structure] and

[the allegedly equivalent structure} are ‘interchangeable

alternatives’ is substantial evidence supporting

equivalence."); Fiskars, Inc. v. Hunt Mfg. Co., 221 F.3d

1318, 1324 (Fed. Cir. 2000) (‘That an element of an accused

device already existed does not bar equivalency as to that

element.").

This line of Federal Circuit cased ignores the change

in the law wrought by Festo and relies instead on this Court's

nineteenth century cases. It culminates in this case, where

the Federal Circuit affirmed a finding of infringement under

the DOE notwithstanding the jury's unchallenged finding that

the accused stents did not have the angular "corners" literally

required by claim 36 and notwithstanding undisputed

evidence that the circular arcs were known in the art and

known to the inventor at the time of the patent as an

alternative to angular "corners."

c. Resolving these Conflicting Lines of

Authority Would Provide Needed

Clarity to Patentees and the Public

Resolving these conflicting lines of Federal Circuit

precedent is important because, as the Federal Circuit has

recognized, "the doctrine of equivalents blurs the line of

demarcation between infringing and non-infringing activity,"

and thus "creates a zone of uncertainty, into which

competitors tread only at their peril," leading to possible

"foreclosure of competitive activity within the penumbra of

each issued patent claim." Sage, 126 F.3d at 1425.

Allowing this conflict in Federal Circuit decisions to

continue unresolved only expands this "zone of uncertainty."

Jd. Providing clarity on these issues would serve the interests

of patentees and the public, reduce the number of patent

disputes and promote legitimate competitive activity.

IV. This Case is an Excellent Vehicle for

Resolving the Issue

This case presents the relevant issue in its starkest

form. The key facts are undisputed. Stents having zig-zag

rings with the claimed angular "corners" and the alleged

equivalent — rings with circular arcs and no "corners" — were

known in the art at the time the patent issued as alternative

designs. Stents having both alternatives were sold by

medical device manufacturers and used by cardiologists.

Both alternatives were taught in prior art patents.

These design alternatives were not merely known in

the art — they were known to the inventor. When the inventor

described earlier stent designs in his patent, he provided two

examples of well-known and "conventional" stent designs —

one with angular comers and one with semicircular rings and

no corners.

eee _— ——— —_ - —

Nothing prevented the inventor from applying for

patent claims that would have covered rings without

"corners" had he considered such designs to be within the

scope of his invention. Both alternatives were known to the

inventor and there are no "shortcomings of language" (Festo,

344 F.3d at 1370) that would have prevented him from

descnbing both alternatives in his patent claims had he

desired to do so.

Under some Fedcral Circuit cases, the patentee's

decision to drafi a claim to cover only one of two or more

known design alternatives operates to bar the patentee from

later asserting that his claim nonetheless covers the other

known alternatives under the DOE. In other cases, including

this one, the Federal Circuit has reached the opposite result.

Patentees and their competitors both would benefit

from a decision that provides clarity by resolving the conflict

between these diametrically opposed lines of precedent.

CONCLUSION

The petition for a writ of certiorari should be granted.

OF Counsel:

Constantine L. Trela, Jr.

SIDLEY AUSTIN LLP

One South Dearborn Street

Chicago, [IL 60603

(312) 853-7000

Respectfully submitted,

Gregory L. Diskant

Counsel of Record

Eugene M. Gelernter

Sean Marshall

PATTERSON BELKNAP WEBB

& TYLER LLP

1133 Avenue of the

Americas

New York, NY 10036

(212) 336-2000

Attorneys for Petitioners

APPENDIX

APPENDIX A

UNITED STATES COURT OF APPEALS FOR THE

FEDERAL CIRCUIT

2008-1003, -1072

CORDIS CORPORATION,

Plaintiff-Appellant,

BOSTON SCIENTIFIC CORPORATION

and SCIMED LIFE SYSTEMS, INC.,

Defendants-Cross Appellants

Gregory L. Diskant, Patterson, Belknap Webb &

l'yler LLP, of New York, New York, argued for plaintiff-

appellant. With him on the brief were Eugene M. Gelernter,

Thomas W. Pippert, Kathleen M. Crotty, Scott W. Parker

and Scott B. Howard, Of counsel was Michael J. Timmons

Of counsel on the brief was Constantine L. Irela, Jr., Sidley

Austin LLP, of Chicago, Illinois.

John M. Desmarais, Kirkland & Ellis LLP, of New

York, New York, argued for defendants-cross appellants.

With him on the brief were Peter J. Armenio, Young J.

Park and Timothy K. Gilman.

Appealed from: United States District Court for the District

of Delaware

Judge Sue L. Robinson

UNITED STATES COURT OF APPEALS FOR THE

FEDERAL CIRCUIT

2008-1003, -1072

CORDIS CORPORATION,

Plaintiff-Appellant,

BOSTON SCIENTIFIC CORPORATION

and SCIMED LIFE SYSTEMS, INC.,

Defendants-Cross Appellants.

Appeals from the United States District Court for the District

of Delaware in case no. 03-CV-027, Judge Sue I. Robinson.

DECIDED: March 31, 2009

Before MAYER and DYK, Circuit Judges, and HUFF,

District Judge.

DYK, Circuit Judge.

” Honorable Marilyn L. Huff, District Judge, United States District

Court for the Southern District of California, sitting by

designation.

Cordis Corporation (“Cordis”) appeals, and Boston

Scientific Corporation and Scimed Life Systems, Inc.

(“Boston Scientific”) cross-appeal, from a final judgment of

the United Siates District Court for the District of Delaware.

The judgment was based on two separate jury verdicts of

infringement: (1) infringement by Boston Scientific of

claims 1 and 23 of U.S. Patent No. 4,739,762 (“the °762

patent”) and claim 2 of U.S. Patent No. 5,895,406 (“the °406

patent”), and (2) infringement by Cordis of claim 36 of US.

Patent No. 5,922,021 (“the ’021 patent’). The judgment also

determined that those claims were not invalid. Cordis Corp.

v. Boston Scientific Corp., Civ. No. 03-027-SLR (D. Del.

Sept. 24, 2007) (judgment). With one minor exception, we

affirm.

BACKGROUND

Cordis and Boston Scientific own patents relating to

intravascular stents, which are cylindrical lattice-like

scaffolds inserted into a blood vessel and then expanded,

often by using a balloon catheter, in order to hold the vessel

open. Cordis owns the ’762 patent and the °406 patent, and

Boston Scientific owns the ’021] patent.

In January 2003, Cordis filed suit against Boston

Scientific, alleging that several of Boston Scientific’s stents

infringe various claims of the ’762 patent and the '406

patent. Boston Scientific counterclaimed, alleging that

several of Cordis’s stents infringe various claims of the ’02]

patent. The district court denied Cordis’s motion for a

preliminary injunction against sales of one of Boston

Scientific’s stents, and we affirmed. Cordis Corp. v. Boston

Scientific Corp., 99 F. App’x 928 (Fed. Cir. 2004).

We treat the Cordis claims and the Boston Scientific

claims separately. Since Cordis is the appellant, we first

discuss Boston Scientific’s claims against Cordis that are the

subject of the Cordis appeal.

ihe Boston Scientific claims: The jury returned

a verdict in July 2005 that (a) Cordis’s Cypher, BX

Velocity, BX Sonic, and Genesis stents do not literally

infringe claim 36 of the ’021 patent; (b) “the Cypher, BX

Velocity, BX Sonic and Genesis stents infringe the ‘corners’

limitation of claim 36 of the ’021 patent under the doctrine

of equivalents”; and (c) claim 36 of the °021 patent is not

invalid for obviousness. Cordis Corp. v. Boston Scientific

Corp., Civ. No. 03-027-SLR, 2006 WL 1305227, at *1 (D. Del.

May 11, 2006) (“Memorandum Opinion”). The district court

denied Cordis’s motion for judgment as a matter of law or, in

the alternative, a new trial.

The Cordis claims: On summary judgment, the

district court determined that claims 1 and 23 of the ’762

patent were not invalid. A separate jury returned a verdict in

favor of Cordis in June 2005 that (a) Boston Scientific’s

Express, Taxus Express, Express Biliary, and Liberté stents

literally infringe claim 23 of the ’762 patent; (b) Boston

Scientific induced literal infringement of claim 1 of the ’762

patent with respect to these stents; (c) the Liberté stent

literally infringes claim 2 of the °406 patent; and (d) claim

2 of the ’406 patent is neither anticipated nor rendered

obvious by the prior art. The district court denied Boston

Scientific’s motion for judgment as a matter of law or, in the

alternative, a new trial.

After the district court entered judgment, Cordis and

Boston Scientific both timely appealed. We have iurisdiction

under 28 U.S.C. §§ 1291, 1292(c)(2), and 1295(a)(1).

DISCUSSION

We review the denial of a motion for judgment as

a matter of law without deference, and we review the denial

of a motion for a new trial for abuse of discretion. Hewlett-

Packard Co. v. Mustek Sys., Inc., 340 F.3d 1314, 1318 (Fed.

Cir. 2003). Each party raises issues that have little merit. We

dispose of those arguments summarily, reserving more

extended discussion for the few issues that merit attention.

We first address Cordis’s appeal.

A. “Wherein” clause construction

Cordis challenges the judgment that its BX Velocity

stent infringes claim 36 of the °021 patent. Claim 36

depends from claim 24, which in turn depends from claim

23. °021 patent col.22 1.42, col.21 1.16.

The procedural posture of this issue is unclear. The

jury found that the accused Cordis stents do not literally

infringe claim 36 of the ’021 patent. Instead of addressing

whether Cordis’s stents infringed claim 36 under the

doctrine of equivalents, the jury was asked only to determine

whether Cordis’s stents “infringe the ‘corners’ limitation of

claim 36 of the °021 patent under the doctrine of

equivalents.” J.A. at 11,238. The jury found that the

“corners” limitation was infringed under the doctrine of

equivalents. Apparently the parties agreed that the BX

Velocity stent infringes all limitations of claim 36 (if

properly construed by the district court) except the

“corners” limitation, but the parties provided no reference

in the record reflecting this agreement. However, the

district court entered judgment of infringement of claim 36,

and we assume that the judgment rests upon such an

agreement.

Cordis first argues that the district court erred in

construing the “wherein” clause of claim 23, and that under

a proper construction of this clause Cordis’s BX Velocity

stent does not infringe claim 36.' The “wherein” clause of

claim 23 describes how the struts within one expansion

column or ring of a stent are connected to the struts of

another column or ring,

wherein the first expansion strut of the first

expansion strut pair in the first expansion

column has a longitudinal axis offset from a

longitudinal axis of the first expansion strut

of the second expansion strut pair in the

second expansion column.

021 patent col.21 Il.1 1-15 (emphasis added). The district court

construed this “wherein” clause in claim 23 to mean “the first

expansion strut in the first column does not share a

longitudinal axis with the second expansion strut in the

second column.” Cordis Corp. v._ Boston Scientific Corp.,

Civ. No. 03-027-SLR, 2005 WL 1322966, at *2 (D. Del.

June 3, 2005) (“Claim Construction”). The district court

refused to construe the “wherein” clause in claim 23 to

exclude so-called “180 degrees out-of-phase” stent designs.

Claim construction is an issue of law, Markman v.

Westview Instruments, Inc., 52 F.3d 967, 970-71 (Fed. Cir.

1995) (en banc), aff'd, 517 U.S. 370 (1996), that we review

without deference, Cybor Corp. v. FAS Technologies Inc.,

138 F.3d 1448, 1456 (Fed. Cir. 1998) (en banc).

Cordis urges that the district court’s construction

improperly failed to exclude stents whose strut pairs are

This argument does not apply to Cordis’s Cypher, BX Sonic, and

Genesis stents.

arranged “180 degrees out of phase,” a phrase that both

parties agree is in common usage in stent design. In such a 180-

degree out-of-phase arrangement, the struts within each

expansion column or ring are connected to form pairs, and

the connected ends of the pairs in one ring face the

connected ends of the pairs in the next ring, forming a

mirror-image pattern. Cordis argues that if claim 23 excludes

such 180-degree out-of-phase designs, then Cordis’s BX

Velocity stent (which uses a 180-degree out-of-phase

design) would not infringe claim 36. Cordis illustrated the

180-degree out-of-phase design with a diagram:

The BX Velocity

Br. for Pl.-Appellant Cordis Corp. 3.

Cordis argues that the same “wherein” clause appears

in both claim 1 and claim 23; that the clauses must have the

same meaning; and that the prosecution history shows that

the “wherein” clause excludes 180-degree out-of-phase

designs. Cordis’s argument is a bit confusing. Ihe issue is

not the meaning of the “wherein” clause. Rather, the problem

stems from the fact that claim 23 and claim | use different

numbering systems, so that, for example, the ‘‘first expansion

strut of the second expansion strut pair in the second

expansion column” is not the same strut in claim 23 as in

claim 1.

Under the numbering system of claim 1, each strut

in a column or ring is either the “first” or “second” strut of

a pair, each pair in the first ring is a “first . . . pair,” and each

pair in the second ring is a “second... . pair.”” Thus in claim

> Claim 1 of the ’021 patent states:

1. A stent in a non-expanded state, comprising:

a first expansion strut pair including a first expansion strut

positioned adjacent to a second expansion strut and a joining

strut of the first expansion strut pair that couples the first and

second expansion struts at a distal end of the first expansion

strut pair, a plurality of the first expansion strut pair forming a

first expansion column;

a second expansion strut pair including a first

expansion strut positioned adjacent to a second expansion

strut and a joining strut of the second expansion strut pair that

couples the first and second expansion struts of the second

expansion strut pair at a proximal end of the second expansion

strut pair, a plurality of the second expansion strut pair forming a

second expansion column;

a first connecting strut including a first connecting strut

proximal section, a first connecting strut distal section and a

first connecting strut intermediate section, the first connecting

strut proximal section being coupled to the distal end of the

first expansion strut pair in the first expansion column and the first

connecting strut distal section being coupled to the proximal

end of the second expansion strut pair of the second

expansion column, a plurality of the first connecting strut forming

a first connecting strut column that couples the first expansion

column to the second expansion column, the first connecting

strut intermediate section being non-parallel to the first connecting

strut proximal and distal sections, wherein the first expansion

strut of the first expansion strut pair in the first expansion column

has a longitudinal axis offset from a longitudinal axis of the

first expansion strut of the second expansion strut pair_in_ the

second expansion column.

‘021 patent col.18 11.9-41 (emphases added)

1, the “wherein” clause requires the first strut of every strut

pair in the first ring to be offset from the first strut of every

strut pair in the second ring, which would not be possible in a

180-degree out-of-phase design. However, under the

numbering system of claim 23, each strut in a ring is

individually numbered “first... second... third... fourth

. , each pair in the first ring is individually numbered

“first. ..second... third... fourth... ,” and each pair in

the second ring is individually numbered “first... second...

third... fourth... .” > Thus in claim 23, the “wherein”

> Claim 23 of the ’021 patent states:

23. A stent in a non-expanded state, comprising:

a first expansion column formed of a plurality of first expansion

column strut pairs, a first expansion strut pair including a first

expansion strut adjacent to a second expansion strut and a first

joining strut that couples the first and second expansion struts at a

proximal end of the first expansion strut pair, a_ second

expansion strut pair including a third expansion strut adjacent to

the second expansion strut and a second joining strut that

couples the second and third expansion struts at a distal end of the

second expansion strut pair, a third expansion_ strut pair

including a fourth expansion strut adjacent to the third

expansion strut and a third joining strut that couples the third

and fourth expansion struts at a proximal end of the third

expansion strut pair, a fourth expansion strut pair including a

fifth expansion strut adjacent to the fourth expansion strut and a

fourth joining strut that couples the fourth and fifth expansion

struts at a distal end of the fourth expansion strut pair, a first

expansion strut pair first corner formed where the first joining

strut is coupled to the first expansion strut, and a first expansion

strut pair second corner formed where the first joining strut is

coupled to the second expansion strut, and a second expansion

strut pair first cormer formed where the second joining strut is

coupled to the second expansion strut, and a second expansion strut

pair second comer formed where the second joining strut is coupled

to the third expansion strut, and a third expansion strut pair first

corner formed where the third joining strut is coupled to the third

10a

expansion strut, and a third expansion strut pair second corner

formed where the third joining strut is coupled to the fourth

expansion strut, and a fourth expansion strut pair first corner

formed where the fourth joining strut is coupled to the fourth

expansion strut, and a fourth expansion strut pair second corner

formed where the fourth joining strut is coupled to the fifth

expansion strut;

a second expansion column formed of a plurality of second

expansion column strut pairs, a first expansion strut _pair

including a first expansion strut adjacent to a second expansion

strut and a first joining strut that couples the first and second

expansion struts at a proximal end of the first expansion strut

pair, a second expansion strut pair including a third expansion

strut adjacent to the second expansion strut and a second

joining strut that couples the second and third expansion struts at a

distal end of the second expansion strut pair, a_ third

expansion strut pair including a fourth expansion strut adjacent

to the third expansion strut and a third joining strut that couples

the third and fourth expansion struts at a proximal end of the

third expansion strut pair, a fourth expansion strut pair including

a fifth expansion strut adjacent to the fourth expansion strut and a

fourth joining strut that couples the fourth and fifth expansion

struts at a distal end of the fourth expansion strut pair, a first

expansion strut pair first corner formed where the first joining

strut is coupled to the first expansion strut, and a first expansion

strut pair second corner formed where the first joining strut is

coupled to the second expansion strut, and a second expansion

strut pair first corner formed where the second joining strut is

coupled to the second expansion strut, and a second expansion strut

pair second comer formed where the second joining strut is coupled

to the third expansion strut, and a third expansion strut pair first

corner formed where the third joining strut is coupled to the third

expansion strut, and a third expansion strut pair second corner

formed where the third joining strut is coupled to the fourth

expansion strut, and a fourth expansion strut pair first corner

formed where the fourth joining strut 1s coupled to the fourth

expansion strut, and a fourth expansion strut pair second corner

formed where the fourth joining strut is coupled to the fifth

expansion strut; and

lla

clause requires only one specific strut (the first strut of the

first pair in the first ring) to be offset from one other specific

strut (the “first expansion strut of the second expansion

Strut pair” in the second ring). Cordis numbered a figure

from the ’021 patent (also known as the Jang patent) to

illustrate these different numbering systems:

a first connecting strut column formed of a plurality of first

connecting struts, each connecting strut of the first connecting

strut column including a connecting strut proximal section, a

connecting strut distal section and a connecting strut

intermediate section, a first connecting strut proximal section is

coupled to the joining strut of the second expansion strut pair of

the first expansion strut column, and a first connecting strut

distal section is coupled to the joining strut of the first expansion

strut pair of the second expansion strut column, and a second

connecting strut proximal section is coupled to the joining strut

of the fourth expansion strut pair of the first expansion strut

column, and a second connecting strut distal section is coupled

to the joining strut of the third expansion strut pair of the second

expansion strut column, the first connecting strut intermediate

section being non-parallel to the first connecting strut proximal

and distal sections wherein the first expansion strut of the first

expansion strut pair _in the first expansion column has a

longitudinal axis offset from a longitudinal axis of the first

expansion strut of the second expansion strut pair in the second

expansion column.

"021 patent col. 19 1.53 —col.21 1.15 (emphases added).

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Br. for Pl.-Appellant Cordis Corp. 40. Because these two

specific struts could be offset from each other but yet aligned

with other struts to form a |180-degree out-of-phase pattern,

the language of claim 23 includes 180-degree out-of-phase

designs. Indeed, the parties appear to agree that on their face

claim | and claim 23 each use a different numbering system

to describe the relative arrangement of a stent’s struts,

with the result that the claim 23 “wherein” clause does not

exclude 180-degree out-of-phase designs. The question is

whether the prosecution history requires that, despite its plain

language, the “wherein” clause of claim 23 be construed to

l3a

use the same numbering system as claim |. Cordis argues that

the prosecution history reflects such a “clear and unmistakable”

disclaimer. Free Motion Fitness, Inc. v. Cybex Int'l, Inc., 423

F.3d 1343, 1353 (Fed. Cir. 2005); see also Omega Eng’ g,

inc., v. Raytek Corp., 334 F.3d 1314, 1325-26 (Fed. Cir.

2003). We cannot agree.

The “wherein” clause was added to claims | and 23

during the prosecution of the ’021 patent after the examiner

rejected both claims as anticipated by European Patent

Application No. 95307687.4, Pub. No. 0 709 067 A2

(““Pinchasik”). Pinchasik discloses a stent whose struts are

arranged in a 180-degree out-of-phase design but whose

struts are not numbered. During the first office action, the

examiner rejected claims | and 23 as anticipated by

Pinchasik, coloring one of Pinchasik’s stent design figures

and numbering parts of the figure (labeled “Figure 2”’)

according to the numbering system of claim 1 of the °021

patent.’ The examiner’s numbering system is, however,

different than claim 23’s numbering system. The examiner’s

rejection in light of Pinchasik made no reference to 180-

degree out-of-phase designs, but simply stated that claim 1,

claim 23, and other claims “are rejected under 35 U.S.C. §

102(b) as being anticipated by Pinchasik” and that “[w]ith

respect to [these claims] . . . refer to the modified Figure 2

attached to this office action.” J.A. at 1705. After the

“wherein” clause was added to claims | and 23, the examiner

allowed both claims. Cordis argues that the examiner used

only the numbering system of claim 1 when allowing both

* The exhibit included at page 7994 of the Joint Appendix shows

that the examiner colored in and labeled the figure from Pinchasik,

but does not disclose numbering of the figure by the examiner.

The parties appear not to dispute that the examiner did number

the figure according to the numbering system of claim 1 of the

‘021 patent.

l4a

claim 1 and claim 23, and that the examiner necessarily

assumed that claim 23 used the same numbering system as

claim 1. However, the examiner did not say so, and we

cannot simply suppose that the claims were allowed based on

an assumed identity of numbering systems. We note that

Cordis does not argue that Pinchasik anticipates claim 23 of

the ’021 patent under the district court’s claim construction,

which suggests that the examiner could have allowed the

claim on other grounds. Cordis also argues that both the

applicant and the examiner referred to stent pairs as

“longitudinally offset,” but these references simply repeat the

“wherein” clause and say nothing about different numbering

systems. Finally, on the disclaimer issue, Cordis argues that

the °021 patent’s provisional application described the

invention as consisting of stents whose flexibility depended

on connections between “split level” (and thus offset) strut

pairs, but again this language in the provisional application

did not discuss the system for numbering these connected

strut pairs. A disclaimer must be “clear and unmistakable,”

and unclear prosecution history cannot be used to limit

claims. Free Motion Fitness, 423 F.3d at 1352-53; see also

Inverness Med. Switz. GmbH v. Warner Lambert Co., 309

F.3d 1373, 1381-82 (Fed. Cir. 2002). The plain language of

claim 23 cannot be overcome by such unclear prosecution

history. Although Cordis urges that no figure in the ’02]

patent uses a 180-degree out-of-phase design, a patent is not

confined to its disclosed embodiments. See Phillips v. AWH

Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005) (en banc).

We affirm the district court’s construction of the

“wherein” clause in claim 23 of the ’021 patent

3. Corners limitation

Alternatively, Cordis argues that the judgment

of infringement of claim 36 of the °021 patent by the BX

Velocity stent should be set aside, because the jury erred in

concluding that the “corners” limitation of claim 36 was

satisfied under the doctrine of equivalents, and because the

district court erred in denying judgment as a matter of law

on this ground. The “corners” limitation appears both in the

language of claim 36 itself and in claim 23, on which

claim 36 depends.’ Cordis does not dispute the district

court’s construction of “corners” as “a place where two

surfaces meet to form an angle.” Claim Construction, 2005

WL 1322966, at *1.

First, Cordis argues that the evidence did not

support the jury’s verdict of infringement of this

limitation under the doctrine of equivalents. A jury’s

determination of infringement is a question of fact that we

review to consider whether it is supported by substantial

evidence. B. Braun Med., Inc. v. Abbott Labs., 124 F.3d

1419, 1423 (Fed. Cir. 1997).

The district court properly found that Boston

Scientific presented sufficient expert testimony that Cordis’s

BX Velocity stent meets the “corners” limitation of claim

* Claim 36 of the ’021 patent states:

36. The stent of claim 24, wherein the first connecting strut

proximal section is coupled to the second corner of the second

expansion strut pair of the first expansion strut column,

and the first connecting strut distal section is coupled to the

first corner of the first cxpansion strut pair of the second

expansion strut column, and the second connccting strut

proximal section is coupled to the second corner of the

fourth expansion strut pair of the first expansion strut

column, and the second connecting strut distal section is

coupled to the first corner of the third expansion strut pair

of the second expansion strut column.

021 patent col.22 I1.42-52 (emphases added).

l6a

36 under the doctrine of equivalents under the function-way-

result test of Graver Tank & Manufacturing Co. v. Linde Air

Products Co., 339 U.S. 605, 608 (1950), a test that is still

useful under Warner-Jenkinson Co. v. Hilton-Davis Chemical

Co., 520 U.S. 17, 39-40 (1997), particularly for mechanical

inventions. Boston Scientific’s expert Dr. Moore testified

that the “corners” in claim 36 and the circular arcs or

rounded corners of the BX Velocity stent both function as

actual and potential reference points for joining adjacent

stent rings, fulfill this function through their similar

locations, and can or do result in offset connections

between stent rings. Such testimony fulfills Boston

Scientific’s obligation to “provide particularized testimony

and linking argument . . . with respect to the function, way,

result test when such evidence is presented to support a

finding of infringement under the doctrine of equivalents.”

Tex. Instruments Inc. v. Cypress Semiconductor Corp., 90

F.3d 1558, 1567 (Fed. Cir. 1996).

Cordis next argues that the doctrine of equivalents

should not be applied in this case because the jury’s finding

of infringement vitiated the “corners” limitation.® Cordis

asserts that the circular arcs of the BX Velocity stent cannot

“form an angle” as required by the district court’s claim

construction. Whether the doctrine of equivalents vitiated a

patent claim is a question of law we review de novo. Pfizer,

Inc. v. Teva Pharms. USA, Inc., 429 F.3d 1364, 1379 (Fed.

Cir, 2005).

The district court properly found that vitiation did not

bar a doctrine of equivalents analysis here. Although we have

“refused to apply the doctrine [of equivalents] .. . where the

accused device contained the antithesis of the claimed

6 . . ‘ .

Cordis also argues that circular arcs were disclaimed. We

find no basis for this in the prosecution history of the ’021 patent.

l7a

structure,” Planet Bingo, LLC v. GameTech International,

Inc., 472 F.3d 1338, 1345 (Fed. Cir. 2006), the circular arcs

of the BX Velocity are not antithetical to the “corners”

limitation in claim 36 of the ’021 patent. Boston Scientific’s

theory that the circular arcs of the BX Velocity stent are

equivalent to the “corners” in claim 36 does not vitiate the

“corners” limitation, because it does not “render[ ] the

pertinent limitation meaningless,” Freedman Seating Co. v.

Am. Seating Co., 420 F.3d 1350, 1359 (Fed. Cir. 2005), or

“effectively eliminate that element in its entirety,” Warner-

Jenkinson, 520 U.S. at 29. See Primos, Inc. v. Hunter's

Specialties, Inc., 451 F.3d 841, 850 (Fed. Cir, 2006).

We affirm the district court’s denial of Cordis’s

motions for judgment as a matter of law or, in the alternative,

a new trial on infringement of the ’021 patent.

C. New claim construction arguments

Cordis argues that the district court improperly declined

after trial to adopt a new construction of “expansion columns”

and “connecting strut columns” in the claims of the 021

patent. In a motion for judgment as a matter of law on

infringement of the ’021 patent, Cordis raised for the first

time the argument that the district court should adopt the

construction of these terms that Boston Scientific had

advocated in a different case relating to the ’021 patent.’ The

district court declined to do so. Cordis Corp. v. Boston

Scientific Corp., Civ. Nos. 03-027-SLR, 03-283-SLR, 2007

WL 2775087, at *1 (D. Del. Sept. 24, 2007).

’ The claim construction Cordis urged the district court

to adopt was appealed to this court and has since been vacated

and remanded. Jang v. Boston Scientific Corp., 532 F.3d 1330,

1331 (Fed. Cir. 2008)

18a

Raising this argument for the first time in a motion

for judgment as a matter of law more than a year after the

jury’s infringement verdict was too late. “[L]itigants waive

their nght to present new claim construction disputes if they

are raised for the first time after trial.” Conoco, Inc. v.

Energy & Envtl. Intl, L.C., 460 F.3d 1349, 1359 (Fed. Cir.

2006); see also Abbott Labs. v. Syntron Bioresearch, Inc.

334 F.3d 1343, 1357 (Fed. Cir. 2003). he district court

properly declined to revise its claim construction in

response to Cordis’s argument.

D. Indefiniteness

Cordis asserts that the district court erred in finding

that claim 23 of the ’021 patent is not indefinite. Cordis

argues that claim 36, and claim 23 on which it depends, are

invalid unless claim 23’s “wherein” clause is construed to

exclude 180-degree out-of-phase designs. Indefiniteness

under 35 U.S.C. § 112 4 2 is an issue of claim construction

and a question of law that we review de novo. Praxair, Inc. v.

ATML, Inc., 543 F.3d 1306, 1319 (Fed. Cir. 2008). We see

no basis for Cordis’s argument. Claim 23 as construed by

the district court is not indefinite.

E. Obviousness

Cordis argues that the jury erred in finding that

claim 36 of the ’021 patent was not invalid for obviousness,

and that the district court erred in denying Cordis’s motion

for judgment as a matter of law of obviousness.

The °021 patent claims priority to its provisional

application. °021 patent col.1 11.6- 8. Cordis first argues that

the district court should have ruled as a matter of law that the

"021 patent was not entitled to a pnority date of April 26, 1996

(when the 021 patent’s provisional application was filed),

and that the correct priority date is April 25, 1997 (when

the ’021 patent’s non-provisional application was filed).

Cordis asserts that the priority date is important because

after April 26, 1996, and before April 25, 1997, inventors

had created stents that demonstrated that claim 36 of the

"021 patent was invalid as obvious under 35 U.S.C. § 103.

Cordis’s basis for challenging the priority date is its theory

that the °021 patent’s April 1996 provisional application did

not provide a sufficient written description of the patent’s

limitations, namely the limitation of claim 36 requiring

connecting struts to be attached on one end at a “second” or

bottom corner of a strut pair and on the other end at a “first”

or top corner.

The written description requirement of 35 U.S.C. §

112 9 1 is a question of fact, and we review a jury’s

findings of fact relating to the written description

requirement for substantial evidence. PIN/NIP, Inc. v.

Platte Chem. Co., 304 F.3d 1235, 1243 (Fed. Cir. 2002).

To comply with the written description requirement, an

applicant must “convey with reasonable clarity to those

skilled in the art that, as of the filing date sought, he or she

was in possession of the invention,” New Railhead Mfg.,

L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1295 (Fed.

Cir. 2002) (quoting Vas-Cath Inc. v. Mahurkar, 935 F.2d

1555, 1563-64 (Fed. Cir. 1991) (emphasis omitted)),

namely that he or she “had invented each feature that is

included as a claim limitation,” New Railhead, 298 F.3d at

1295. The district court cited uncontradicted testimony

from Boston Scientific’s expert Dr. Moore that the °021]

patent’s provisional application provided a_ sufficient

written description of the limitations of claim 36. We

conclude that the jury could properly find that the °021

patent was entitled to an April 1996 priority date.

Cordis alternatively argues that regardless of

whether the ’021 patent has a priority date of April 1996 or

April 1997, several earlier patents® were prior art rendering

claim 36 obvious. Cordis asserts that it would have been

obvious to one of ordinary skill in the art to combine

features of these patents to create stents with the bottom-

corner-to-top-corner connecting struts disclosed in claim 36

of the ’021 patent.

“We review ‘[the] jury’s conclusions on obviousness,

a question of law, without deference, and the underlying

findings of fact .. . for substantial evidence.’” Johns Hopkins

Univ. v. Datascope Corp., 543 F.3d 1342, 1345 (Fed. Cir.

2008) (quoting LNP Eng'g Plastics, Inc. v. Miller Waste

Mills, Inc., 275 F.3d 1347, 1353 (Fed. Cir. 2001)). The

district court cited uncontradicted testimony from Boston

Scientific’s expert Dr. Moore that the prior art patents cited

by Cordis would be unlikely to be combined to create the

connectors of claim 36 of the ’021 patent, and that these prior

art patents taught away from the bottom-to-top connectors

described in claim 36 by describing features of such

connectors as potentially harmful. The district court properly

concluded there was substantial evidence that these prior art

patents did not render claim 36 obvious.

We affirm the district court’s denial of Cordis’s

motion for judgment as a matter of law or, in the alternative,

a new trial on invalidity of the ’021 patent.

We next address Boston Scientific’s cross-appeal.

* US. Patent Nos. 5,102,417: 5,449,373: 5,643,312;

5,733,303; and 6,348,065.

A. Monographs

Boston Scientific argues that the district court

erred in holding that two monographs prepared by the

inventor of the ’762 patent are not prior art, and erred in

granting Cordis’s motion for summary judgment that the

asserted claims of the °762 patent are not invalid “as to the

asserted claims being invalidated by the Palmaz

Monographs.” Cordis Corp. v. Boston Scientific Corp.,

Civ. No. 03-027-SLR (D. Del. June 3, 2005) (summary

judgment order).

If there are no facts in dispute, whether a reference

is a prior art “printed publication” within the meaning of 35

U.S.C. § 102(b) is a question of Jaw.” In re Klopfenstein,

380 F.3d 1345, 1347 (Fed. Cir. 2004). Because the facts

of the distribution of Dr. Palmaz’s monographs are not in

dispute, we review de novo the issue of whether the

monographs are prior art printed publications.

In 1980 the inventor of the ’762 patent, Dr. Palmaz,

prepared a ten-page paper describing his work on stents. This

paper is the “1980 monograph.” At that time he was a

resident at a hospital in California. His name was not on

the paper. He gave copies of the paper to approximately six

of his teachers at an oral presentation of his work to these

physicians and several other colleagues. Pursuant to

agreements, Palmaz later gave copies of the monograph to two

companies (Vascor, Inc., and Shiley, Inc.) while attempting to

% Under 35 U.S.C. § 102, “[a] person shall be entitled to a

patent unless. . . (b) the invention was patented or described in a

printed publication in this or a foreign country or in public use or

on sale in this country, more than one year prior to the date of

the application for patent in the United States.”

22a

commercialize his stent technology.'® Neither agreement

required confidentiality, and the Shiley agreement

specifically stated that Shiley “shall not be committed to

keep secret any idea or material submitted.” J.A. at 19,473.

In 1983 Dr. Palmaz revised the paper; the revised paper

became the “1983 monograph.” In 1983 he also gave a

copy of both monographs to Werner Schultz, a technician

from whom Dr. Palmaz was seeking fabrication assistance.

When Dr. Palmaz joined the faculty in 1983 at the

University of Texas, San Antonio, he gave a copy of the

1983 monograph to a doctor there (who then gave it to the

technician setting up Dr. Palmaz’s laboratory) and to the

university as part of a research proposal. Dr. Palmaz applied

for the patent that became the 762 patent in 1985.

A document is publicly accessible if it “has been

disseminated or otherwise made available to the extent that

persons interested and ordinarily skilled in the subject matter

or art, exercising reasonable diligence, can locate it and

recognize and comprehend therefrom the essentials of the

claimed invention without need of further research or

experimentation.” In_ re Wyer, 655 F.2d 221, 226 (CCPA

1981) (quoting LC.E. Corp. v. Armco Steel Corp., 250 F.

Supp. 738, 743 (S.D.N.Y.1966)). In general, “[a]ccessibility

goes to the issue of whether interested members of the relevant

public could obtain the information if they wanted to.”

Constant v. Advanced Micro-Devices, Inc., 848 F.2d

1560, 1569 (Fed. Cir. 1988). Many of our cases in this

area have concerned publications available in libraries,

and the question has been whcther the publication has been

sufficiently indexed to be publicly accessible. See, e.g., In re

Cronyn, 890 F.2d 1158, 1161 (Fed. Cir. 1989); In re Hall,

'° ‘The parties here agree that there is no evidence that copies

of the monographs were given to a third commercial entity,

Cook Inc., before the critical date of the "021 patent.

23a

781 F.2d 897, 899 (Fed. Cir. 1986); In re Wyer, 655 F.2d at

226. Other cases have involved widespread distribution so

that the public could easily obtain copies of the publication.

See, e.g., Kyocera Wireless Corp. v. Int’] Trade Comm’n,

545 F.3d 1340, 1350-51 (Fed. Cir. 2008).

Here we have a somewhat different question: whether

the distribution to a limited number of entities without a legal

obligation of confidentiality renders the monographs printed

publications under § 102(b). We have held that where a

distribution is made to a limited number of entities, a

binding agreement of confidentiality may defeat a finding of

public accessibility. But we have also held that such a

binding legal obligation is not essential. Klopfenstein, 380

F.3d at 1351. We have noted that “[w]here professional

and behavioral norms entitle a party to a reasonable

expectation” that information will not be copied or further

distributed, “we are more reluctant to find something a ‘printed

publication.’”!' Id. at 1350-51.

We first discuss Dr. Palmaz’s distribution of copies

of his monographs to his university and hospital colleagues.

We have recognized the importance of “preserv[ing] the

incentive for inventors to participate in academic

presentations or discussions” by noting that professional

norms may support expectations of confidentiality. Id. at

‘' In the public use context of § 102(b), we have similarly

noted that a lack of an express promise of confidentiality is not

determinative of public use, but is instead “one factor to be

considered in assessing all the evidence.” Bernhardt, L.L.C. v.

Collezione Europa USA, Inc., 386 F.3d 1371, 1379 (Fed. Cir. 2004)

(quoting Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261,

1266 (Fed. Cir. 1986)), abrogated on other grounds by Egyptian

Goddess, Inc. v. Swisa, Inc., $43 F.3d 665 (Fed. Cir. 2008) (en

banc); see also Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d

1374, 1382 (Fed. Cir. 2005).

24a

1351. The record here contains clear evidence that such

academic norms gave rise to an expectation that

disclosures will remain confidential.'? Cordis’s expert

Dr. Buller testified that the “code of practice which occurs

worldwide in academic circles, in departments, in medicine”

includes treating a document describing scientific research

in the “same confidential manner as you would if you had

been given it directly by the author.” J.A. at 8540-41. The

district court properly concluded that Dr. Palmaz’s

distribution of the monographs to his academic and research

colleagues did not render the monographs prior art printed

publications.

However, Boston Scientific urges that, even if the

academic and hospital distributions did not create public

accessibility, the distribution of monographs to two

commercial entities did so. These distributions occurred

during attempts to interest the two companies in

development of Dr. Palmaz’s stent designs. There is no

claim here that the two commercial entities provided any

express agreement to keep the document confidential; indeed,

one entity’s disclosure agreement did not discuss the entity’s

confidentiality obligations, and the other’ entity’s

disclosure agreement’ specifically disclaimed such

obligations (most likely to avoid a lawsuit resulting from

inadvertent disclosure). Boston Scientific argues that under

the decision of our predecessor court, the Court of Claims,

in Garrett Corp. v. United States, “[w]hile distribution [of

The only potentially contrary testimony is a statement

in a report by Boston Scientific’s expert that a “colleague,

faculty member or other recipient [of the monographs] . . . would

be under no obligation to maintain the disclosure in confidence.”

J.A. at 19,386. As we have discussed, whether or not recipients

have a legal obligation to maintain confidentiality is not

determinative.

25a

a government report] to government agencies and personnel

alone may not constitute publication, distribution to

commercial companies without restriction on use clearly

does.” 422 F.2d 874, 878 (Ct. Cl. 1970) (citation omitted).

However, the evidence here was sufficient to support

a conclusion that there was an expectation of confidentiality

between Dr. Palmaz and each of the two commercial

entities. While the Shiley legal agreement executed before

development discussions disclaimed a_ confidentiality

requirement, Dr. Palmaz testified that he requested

confidentiality during subsequent discussions and was

“surprise[d]” when he was shown the language of the Shiley

agreement. J.A. at 8517; id. at 19,354. There is no

Suggestion that the request for confidentiality was not, in

fact, honored. Dr. Palmaz confirmed that the entities kept

their copies of the monograph confidential, whether or not

they were legally obligated to do so. J.A. at 8502. The

district court noted that “there is no evidence that [the

commercial entities] would have distributed, or in fact did

distribute, the 1980 Monograph outside of the company.”

Cordis Corp. v. Boston Scientific Corp., Civ. No. 03-027-

SLR, 2005 WL 1331172, at *4 (D. Del. June 3, 2005). There

was no showing that similar documents in the past became

available to the public as a result of disclosure by these or

similar commercial entities, that these or similar commercial

entities typically would make the existence of such

documents known and would honor requests for public

access, or that these or similar commercial entities had an

incentive to make the document available, etc. The mere fact

that there was no legal obligation of confidentiality—all that

was shown here—is not in and of itself sutficient to show

26a

that Dr. Palmaz’s expectation of confidentiality was not

reasonable.’

We affirm the district court’s holding that Dr.

Palmaz’s 1980 and 1983 monographs were not prior art

printed publications under § 102(b), and we affirm the

district court’s grant of Cordis’s summary judgment motion

that the claims of the ’762 patent are not invalidated by the

Palmaz monographs.

B. Anticipation

Boston Scientific argues that the jury erred in

finding that claim 2 of the °406 patent is not invalid, and

that the district court erred in not granting judgment as a

matter of law on grounds of anticipation. Anticipation is a

question of fact; we review the jury’s verdict for substantial

evidence. Voda v. Cordis Corp., 536 F.3d 1311, 1321 (Fed.

Cir. 2008).

Boston Scientific’s theory is that Cordis’s °762

patent anticipates claim 2 of Cordis’s °406 patent. The

parties agree that the *762 patent includes all elements of

claim 2 of the ’406 patent, save for the functional language in

claim | of the ’406 patent (on which claim 2 of the °406

patent depends). This functional language states, “such that

the links and bands define an expandable structure having

'> Boston Scientific asserted that the district court improperly

did not allow it to argue that the monographs were prior art in

light of the result of a different litigation involving the 762 patent.

We do not need to reach the question of whether the carlier

determination that the 762 patent was “valid” precluded further

litigation of the validity determination in this case.

27a

axial flexibility in an unexpanded configuration.” ’406 patent

col.5 1].35-39 (emphases added).'*

Boston Scientific argues that this “such that” claim

language cannot operate as a claim limitation to distinguish

the °406 patent over the prior art. Contrary to Boston

Scientific’s argument, we have held that functional .

language can be a claim limitation. See Microprocessor

Enhancement Corp. v. Tex. Instruments Inc., 520 F.3d 1367,

1375 (Fed. Cir. 2008). We conclude that the jury could properly

find that the ‘such that” claim language is a limitation of claim

1 of the °406 patent that barred a finding of anticipation.

Boston Scientific alternatively argues that even if the

“such that” functional language limits claim 2 to stents

“having axial flexibility,” the evidence demonstrated that the

°762 patent disclosed such axial flexibility. The district court,

'* Claims | and 2 of the 406 patent state:

1. A stent having first and second ends with an intermediate

section therebetween, and a longitudinal axis, comprising:

a plurality of longitudinally disposed bands, wherein each band

defines a generally continuous wave having a spatial frequency

along a line segment parallel to the longitudinal axis; and

a plurality of links for maintaining the bands in a tubular

structure, wherein the links are so disposed that any single

circumferential path formed by the links is discontinuous;

such that the links and bands define an expandable structure

having axial flexibility in an unexpanded configuration.

2. A stent according to claim 1, wherein each link is axially

displaced from any circumferenttally adjacent link.

‘406 patent col. 5 11.26-41 (emphases added).

28a

citing both the testimony of Boston Scientific’s expert Dr.

Moore and the presumption of a patent’s validity, held that

the evidence presented was sufficient for the jury to find that

the °762 patent did not anticipate claim 2 of the °406

patent. The district court properly concluded that

substantial evidence supported the jury’s verdict that claim 2

of Cordis’s ’406 patent was not invalid.

We affirm the district court’s denial of Boston

Scientific’s motion for judgment as a matter of law that claim

2 of the ’406 patent is anticipated and invalid.

C. “Thin-walled”’

Boston Scientific argues that the jury erred in

finding that Boston Scientific’s Express and laxus Express

stents literally infringe claim 23 of the ’762 patent, and in

finding that Boston Scientific induced literal infringement of

claim 1 of the °762 patent with respect to these stents.’

'S Claims 1, 13, and 23 of the ’762 patent state:

l. A method for implanting a prosthesis within a body

passageway comprising the steps of:

utilizing a thin-walled, tubular member as the prosthesis, the

tubular member having a plurality of slots formed therein, the slots

being disposed substantially parallel to the longitudinal axis of

the tubular member;

disposing the prosthesis upon a catheter;

inserting the prosthesis and catheter within the body passageway

by catheterization of said body passageway; and

expanding and deforming the prosthesis at a desired location

within the body passageway by expanding a portion of the

catheter associated with the prosthesis to force the

29a

Claim 23 of the ’762 patent depends from claim 13. ’762

patent col.12 11.55-60. Boston Scientific also argues that

the district court erred in denying its motion for judgment

as a matter of law of noninfringement under the “thin-

walled” limitation of claim | and claim 13.

prosthesis radially outwardly into contact with the body

passageway, the prosthesis being deformed beyond its elastic

limit,

13. An expandable intraluminal vascular graft, comprising:

a thin-walled tubular member having first and second ends and

a wall surface disposed between the first and second ends, the

wall surface having a substantially uniform thickness and a

plurality of slots formed therein, the slots being disposed

substantially parallel to the longitudinal axis of the tubular

member,

the tubular member having a first diameter which permits

intraluminal delivery of the tubular member into a_ body

passageway having a lumen, and

the tubular member having a second, expanded and deformed

diameter, upon the application from the interior of the tubular

member of a radially, outwardly extending force, which

second diameter is variable and dependent upon the amount of

force applied to the tubular member, whereby the tubular member

may be expanded and deformed to expand the lumen of the

body passageway.

23. The expandable intraluminal vascular graft of claim 13,

wherein the outside of the wall surface of the tubular member is a

smooth surface, when the tubular member has the first diameter.

'762 patent col.10 1.6-col.11 1.9; col.1] 1.62—col.12 1.15; col.12

11.55-60 (emphases added).

30a

First, Boston Scientific argues that the district court

construed the term “thin-walled” improperly. The district

court construed “thin-walled” in claim | and claim 13 of the

°762 patent as “the wall of the tubular member must have

little extent from one surface to its opposite at both its first

and second diameters.” Claim Construction, 2005 WL

1322966, at *2. The district court’s claim construction was

proper, and the district court was not obligated, as Boston

Scientific urges, to construe “thin-walled” to exclude stent

walls whose struts are thicker than they are wide.

Second, Boston Scientific complains that the district

court refused to allow Boston Scientific to argue the

prosecution history of the *762 patent to the jury, and that the

district court’s exclusion of this argument prejudiced Boston

Scientific’s noninfringement case. Boston Scientific had

sought to use the prosecution history of the °762 patent to

show that Cordis had admitted that stents whose thicknesses

were within a particular numerical range were not “thin-

walled.”'® In effect, Boston Scientific sought to argue claim

construction to the jury. We have held that it is improper to

argue claim construction to the jury because the “risk of

confusing the jury is high when experts opine on claim

construction.” CytoLogix Corp. v. Ventana Med. Sys., Inc.,

424 F.3d 1168, 1172-73 (Fed. Cir. 2005); see Sundance,

Inc. v. DeMonte Fabricating Ltd., 550 F.3d 1356, 1364 n.6

(Fed. Cir. 2008). The district court thus properly excluded

Boston Scientific’s claim construction argument before the

jury, and properly held that its exclusion of this argument

did not entitle Boston Scientific to a new trial.

When affirming the district court’s denial of Cordis’s

preliminary injunction motion in this case, we found no error in

the district court’s conclusion that the prosecution history did not

limit “thin-walled” to “thicknesses no greater than 0.0045 inches.”

Cordis Corp., 99 F. App’x at 933

3la

Third, Boston Scientific argues that even under

the district court’s claim construction, Cordis did not

present sufficient evidence that the Express and Taxus

Express stents meet the “thin-walled” limitations of claim |

and claim 13 (on which claim 23 depends). The district court

cited testimony by Cordis’s expert Dr. Buller describing how

the Express and Taxus Express stents meet the “thin-walled”

limitation of claims | and 23 under the district court’s

construction of this limitation. Memorandum Opinion, 2006

WL 1305227, at *12. We conclude that the district court

properly found that Cordis presented substantial evidence to

support the jury's infringement verdict.

We affirm the district court’s denial of Boston

Scientific’s motion for judgment as a matter of law that the

Express and Taxus Express stents do not infringe claims |

and 23 of the ’762 patent under the “thin-walled” limitation

of these claims.

D. “Substantially parallel’

Boston Scicntific argues that the jury crred in

finding that Boston Scientific’s Liberté stent infringes

claims | and 23 of the ’762 patent, and that the district court

erred in denying Boston Scientific’s motion for judgment as

a matter of law of noninfringement under the “substantially

paralle]”’ limitations of claim 1 and claim 13 (on which claim 23

depends). Both claim 1 and claim 13 describe stents whose

slots (spaces or Openings within a stent’s lattice design) are

“disposed substantially parallel to the longitudinal axis” of

the stent. °762 patent col.10 1.61—col.1] 1.9; col.11 1.62

col.12 1.15 (emphasis added).

Boston Scientific first contends that the district court

erred by not construing the term “parallel” in claim 1 and

claim 13 of the ’762 patent. This argument was not timely

32a

raised before the district court and has been waived. Conoco

460 F.3d at 1359.

Next, Boston Scientific argues that Cordis did not

present substantial evidence that the Liberté stent meets the

“substantially parallel” limitation in claims 1 and 23. Boston

Scientific asserts that the Liberté stent’s banana-shaped slots

are not substantially parallel to the stent’s longitudinal axis.

The district court cited testimony of both parties’ experts to

support its finding that Cordis provided sufficient evidence to

support the jury’s’ infringement verdict under the

“substantial’y parallel’ limitation. Memorandum Opinion,

2006 WL 1305227, at *10. We conclude that substantial

evidence supported the jury’s verdict.

Boston Scientific further asserts that the district

court’s exclusion of the deposition testimony about the

Liberté stent by Dr. Palmaz, the inventor of the ’762 patent,

warrants a new trial. Dr. Palmaz testified during a deposition

that the slots of the Liberté stent “deviate from the

longitudinal axis” of the stent. J.A. at 11,520. The district

court excluded this testimony, finding that Dr. Palmaz was

not an expert on the Liberté stent and that his testimony did

not provide relevant evidence of infringement and created a

risk of prejudice. Memorandum Opinion, 2006 WL 1305227,

at *14. Boston Scientific argues that this testimony of Dr.

Palmaz was important in defining the meaning of the claim

term “substantially parallel” and in rebutting Cordis’s

evidence that the Liberté stent infringed claims 1 and 23 of

the °762 patent. As noted earlier, claim construction cannot

be argued to the jury. CytoLogix Corp., 424 F.3d at 1172-

73; see also Sundance, 550 F.3d at 1364 n.6. “[I]nventor

testimony as to the inventor's subjective intent is irrelevant

to the issuc of claim construction,” and as the inventor of the

"762 patent, Dr. Palmaz also had no special expertise

regarding the alleged infringement of the patent by the

Liberté stent. Howmedica Osteonics Corp. v. Wright Med.

33a

Tech., Inc., 540 F.3d 1337, 1346-47 (Fed. Cir. 2008); see

also Air Turbine Tech., Inc. v. Atlas Copco AB, 410

F.3d 701, 714 (Fed. Cir. 2005). The district court’s

exclusion of the Liberté stent portion of Dr. Palmaz’s deposition

testimony was within its discretion.

We affirm the district court’s denial of Boston

Scientific’s motion for judgment as a matter of law or a new

trial that the Liberté stent does not infringe claims 1 and 23

of the ’762 patent under the “substantially parallel” limitation

of these claims.

E. “Wave”

Boston Scientific contends that the jury erred in

finding that the Liberté stent infringes claim 2 of the °406

patent, and that the district court erred in denying Boston

Scientific’s motion for judgment as a matter of law of

noninfringement. Claim 2 of the ’406 patent depends from

claim 1. °406 patent col.5 11.39-41. The parties agree that the

Liberté stent infringes all! limitations of claim 2, except the

limitation in claim 1 (on which claim 2 depends) describing “‘a

plurality of longitudinally disposed bands, wherein each band

defines a generally continuous wave having a spatial

frequency along a line segment parallel to the longitudinal

axis.” ’406 patent col.5 11.29-32 (emphasis added).

First, Boston Scientific argues that the district court

improperly refused to construe the term “wave” in claim 1. In

fact, the district court did construe the claim language

“longitudinally disposed bands, wherein each band defines a

generally continuous wave having a spatial frequency

along a line segment parallel to the longitudinal axis” as

“the stent has multiple elongated surfaces that run parallel to

the stent’s long axis, cach of these surfaces having the

undulating appearance of a continuous wave,” though it

34a

did not separately construe the term “wave.” Claim

Construction, 2005 WL 1322966, at *1.

As the district court pointed out, Boston Scientific did

not suggest until after the close of the trial that the district

court was required to construe the term “wave” in any other

respect. Memorandum Opinion, 2006 WL 1305227, at *6.

Under Conoco, this argument thus was not timely raised

before the district court and has been waived. 460 F.3d at

1359.

Alternatively, Boston Scientific argues that even

under the district court’s claim construction, the evidence

did not sufficiently support the jury’s infringement verdict.

This contention is without merit. The district court cited

testimony by Cordis’s expert Dr. Buller applying the court’s

claim construction and describing how the Liberté stent

meets the limitations of claim 2 of the °406 patent.

Memorandum Opinion, 2006 WL 1305227, at *4 . We

conclude that Cordis presented substantial evidence to support

the jury’s infringement verdict.

We affirm the district court’s denial of Boston

Scientific’s motion for judgment as a matter of law that the

Liberté stent does not infringe claim 2 of the 406 patent.

F. Dismissal without prejudice

The district court granted Boston Scientific’s

motion for judgment as a matter of law that its Taxus

Liberté stent (not to be confused with its Liberté stent or its

Taxus Express stent) did not infringe the asserted claims of

Cordis’s ’762 and ’406 patents. The district court held that it

did not have jurisdiction to consider infringement claims

relating to the Taxus Liberté stent because that stent had

“no nexus to the United States.” Memorandum Opinion,

2006 WL 1305227, at *24.

35a

However, Boston Scientific argues that the district

court erred in dismissing Cordis’s infringement claims

against the Taxus Liberté stent without prejudice, rather than

with prejudice, and asserts that Cordis failed to prove that the

Taxus Liberté stent infringed the asserted claims of the °762

and °406 patents. Cordis asserts that it did not present

evidence at trial that the Taxus Liberté stent infringed the

asserted claims of the 762 and °406 patents under 35 U.S.C.

§ 271(f) because it believed such evidence related only to

damages rather than to infringement liability. '’

“Congress has not clearly stated in 35 U.S.C. § 271 or

in any other statute that § 271’s requirement that the

infringing act happen within the United States is a threshold

jurisdictional requirement as opposed to an element of the

claim.” Litecubes, LLC v. N. Light Prods., Inc., 523 F.3d

1353, 1363 (Fed. Cir. 2008), cert. denied sub nom.

GlowProducts.com v. Litecubes, LLC, 129 S. Ct. 578 (2008).

Thus, the question of whether the Taxus Liberté stent had a

nexus to the United States was an element of Cordis’s

liability claims, rather than a jurisdictional requirement.

Because “a failure to prove the allegations alleged in a

complaint requires a decision on the merits, not a dismissal

for lack of subject matter jurisdiction,” id. at 1361, the

district court’s dismissal of Cordis’s infringement claims

regarding the Taxus Liberté stent should have been with

prejudice.

We reverse the district court’s dismissal without

prejudice of Cordis’s claims that the Taxus Liberté stent

infringed the asserted claims of the ’762 and °406 patents,

Cordis argues that the Taxus Liberté stent has the same

structure as the Liberté stent. We see no error in the district court’s

determination that the Taxus Liberté stent and the Liberté stent are

different products.

36a

and remand with instructions to dismiss the claims with

prejudice.

li]

We affirm the district court’s judgment in all

respects save one. We reverse the district court’s dismissal

without prejudice of Cordis’s claims that the Taxus Liberté

stent infringed the asserted claims of the °762 and °406

patents, and remand with instructions to dismiss the claims

with prejudice.

AFFIRMED-IN-PART, REVERSED-IN-PART,

REMANDED

COSTS

No costs.

APPENDIX B

IN THE UNITED STATES DISTRICT COURT FOR

THE DISTRICT OF DELAWARE

CORDIS CORPORATION, )

)

Plaintiff, )

)

v. ) Civ. No. 03-027-SLR

)

BOSTON SCIENTIFIC )

CORPORATION and SCIMED )

LIFE SYSTEMS, INC., )

)

Defendants. )

ORDER

At Wilmington this | 1" day of May, 2006, consistent

with the memorandum opinion issued this same date;

IT IS ORDERED that:

g BSC's renewed motion for judgment as a

matter of law of noninfringement and invalidity (D.I. 378) is

denied;

ee BSC's motion for reconsideration of

the without prejudice aspect of the court's order dismissing

Cordis’ infringement claims against the Taxus Liberté stent

(D.1. 382) ts denied; and

3. Cordis’ renewed motion for judgment as a

matter of law, or, in the alternative, a new tnal on

3508664v.1

38a

infingement and invalidity of the '021 patent (D.I. 398) is

denied.

4. The Clerk of Court is directed to enter

judgment consistent with the verdicts (D.I. 360, D.I.

381) reached by each of the juries.

Mot

United Statles Brairint Judge

4$08664v 1

39a

APPENDIX C

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF DELAWARE

CORDIS CORPORATION,

Plaintiff,

Ne Ne eee ee”

v. Civ. No. 03-027-SLR

BOSTON SCIENTIFIC

CORPORATION and

SCIMED LIFE SYSTEMS, INC.,

Defendants.

BOSTON SCIENTIFIC SCIMED,

INC. and BOSTON SCIENTIFIC

CORPORATION,

Plaintiffs,

Civ. No. 03-283-SLR

Vv.

CORDIS CORPORATION and

JOHNSON AND JOHNSON, INC.,

Defendants.

MEMORANDUM ORDER

At Wilmington this 24th day of September, 2007,

having reviewed the various pending motions of Cordis

Corporation ("Cordis") in the above captioned cases, and the

papers filed in connection therewith;

3512004v |

40a

IT IS ORDERED that Cordis's motion for judgment

as a matter of law or, in the alternative, a new trial, on

infringement of U.S. Patent No. 5,922,021 ("the '021 patent")

(Civ. No. 03-027-SLR, D.l. 426) is denied, for the reasons

that follow:

l. Procedural background. The above

captioned litigation involves cross-claims of infringement by

Cordis and Boston Scientific Corporation ("BSC"),' which

parties count among the major players in the very lucrative

medical device market related to interventional cardiology.

More specifically, the patents at issue relate to stents,

construed in this case as “tubular structure{s] left inside a

vessel to hold the vessel open." Stent technology has

advanced over the years (and the focus of the litigation has

evolved) from various designs of bare metal stents to using

those same designs as platforms for drug-eluting stents

("DES").

2. With respect to the instant litigation, the two

cases were tried to scparate juries and, in June 2005, the

following verdicts were returned: (a) BSC's Express, Taxus

Express, and Express Biliary stents (collectively, "the

Express stents"), as well as the Liberte stents, literally

infringe claim 23 of U. S. Patent No. 4,739,762 ("the '762

patent"); (b) BSC has induced literal infringement of claim 1

of the '762 patent with respect to those stents; (c) the Liberte

stent literally infringes claim 2 of U.S. Patent No. 5,895,406

("the '406 patent"); (d) claim 2 of the '406 patent is neither

anticipated nor rendered obvious by the prior art; (e) Cordis's

Cypher stent infringes claim 8 of U.S. Patent No. 6,120,536

' The parties to this litigation have undergone various

corporate iterations. For ease of reference, however, the court

has designated only "Cordis" and "BSC" as the primary

litigants.

3512004v.1

("the '536 patent"); (f) claim 8 of the '536 patent is not

invalid for obviousness; (g) Cordis' Cypher, BX Velocity,

BX Sonic and Genesis stents do not literally infringe claim

36 of the '021 patent; (h) the Cypher, BX Velocity, BX Sonic

and Genesis stents infringe the "corners" limitation of claim

36 of the '021 patent under the doctrine of equivalents; and

(i) claim 36 of the '021 patent is not invalid for obviousness.

(Civ. No. 03-027-SLR, D.I. 360, 381) The parties filed post-

trial motions, which were resolved by memorandum opinion

and order dated May 11, 2006. (Civ. No. 03-027-SLR, D.1.

416, 417) Cordis has since filed a motion for

reconsideration,” the pending motion for judgment as a

matter of law (its second such motion), and a motion for a

new trial on the '536 patent based on newly discovered

evidence concerning the incidence of late thrombosis (Civ.

No. 03-283-SLR, D.I. 515).

a Shortly before trial was conducted in the

above captioned cases, the named inventor of the '021 patent,

G. David Jang, M.D. ("Dr. Jang"), filed suit against BSC in

the Central District of California. (D.I. 427 at ex. A) In his

lawsuit, Dr. Jang charged, inter alia, that BSC was in

violation of a certain Assignment Agreement whereby BSC

had agreed to pay Dr. Jang up to $160 million based on

revenues generated by products developed by BSC that

incorporated Dr. Jang's coronary stent technology or patents,

including the '021 patent. In order to determine whether

BSC's stents were subject to the payment obligation (i.e.,

whether the BSC stents were "Contingent Payment Products"

under the Assignment Agreement), the court had to

determine whether the stents infringed the '021 patent.

Consistent with the familiar two-step infringement analysis,

the court construed the disputed claim limitations of the '021

* (Civ. No. 03-027-SLR, D.I. 418, resolved by D.I. 429)

3§12004v.1

42a

patent. (D.I. 427 at ex. F)

4. Analysis. Cordis asserts at bar that this court

should adopt the claim construction that BSC successfully

advocated in the California case and should enter judgment

of noninfringement based on that claim construction. The

court agrees with Cordis in principle that courts are free to

revise their interlocutory rulings on claim construction at any

time prior to the entry of judgment and that, generally, a

patent's claim limitations should be construed consistently

from one party to another. Nevertheless, the court declines to

overturn the jury verdict (a verdict that followed a

voluminous motion practice) under the circumstances at bar.

Significantly, Cordis never presented to this court for its

consideration the specific claim construction disputes now

identified by Cordis as being critical to its noninfringement

case. (Compare, e.g., Civ. No. 03-027-SLR, D.1I. 307, 368

with DA. 427 and exs. C and F) Cordis is not only asking the

court to nullify a multitude of proceedings based on post-trial

stratagems’ but, in essence, Cordis is asking the court to

embrace a claim construction that is neither binding on the

court nor necessarily persuasive’ The court declines to

exercise its discretion in this manner.

IT IS FURTHER ORDERED that Cordis’ motion for

a new trial on the '536 patent based on newly discovered

evidence concerning the incidence of late thrombosis (Civ.

’ The court acknowledges that Cordis moved to stay trial on

the '021 patent just days before trial was to commence, which

motion was denied by the court. (Civ. No. 03-027-SLR, D.L.

342, 351)

According to Cordis, the court in California adopted the

construction of the claim limitations at issue as advocated by

BSC.

3512004y 1

43a

No. 03-283-SLR, D.I. 515) is denied, for the reasons that

follow:

1. Factual background. Unlike the ‘021 patent,

which covers bare metal stents, the '536 patent is directed at a

DES whose "topcoat" comprises "a_ biostable, non-

thrombogenic material which provides long-term non-

thrombogenicity to the device portion during and after

release" of the drug. The above quoted limitation of claim |

of the '536 patent” was construed by the court to mean "a

matcrial that docs not promote thrombosis for a period of

time that extends both during and after release of the

biologically active material." (Civ. No. 03-283-SLR, D.1.

368) During the course of the trial, all parties conceded that

bare meta] stents were known to be thrombogenic, and that

the thrombosis rates for Cordis's Cypher stent and bare metal

stents were essentially the same. Based on this undisputed

evidence, Cordis argued to the jury that the material in the

Cypher's topcoat was not "non-thrombogenic" within the

meaning of claim 8; BSC argucd to the jury that the Cypher

stent cannot be said to "promote" thrombosis because there

are no additional thrombosis problems over bare metal stents.

2. More than a year after the jury reached its

verdict in favor of BSC on this issue, the FDA announced the

following:

We are aware of recent data suggesting a

small but significant increase in the rate of

death and myocardial infarction (heart attack)

possibly due to stent thrombosis (a blood clot

in the stent) in paticnts treated with DES

[drug-eluting stents]. The specific studies that

* Claim 8 of the '536 patent depends from claim 1.

3512004v.1

44a

have prompted recent media inquirics are

the BASKET-LATE study (presented at the

March 2006 American College of Cardiology

Scientific Sessions in Atlanta, Ga.) and more

recently, the Camenzind meta-analysis

(presented at the September 2006 European

Society of Cardiology Annual Meeting/World

Congress of Cardiology Meeting in

Barcelona, Spain). The small but significant

increase in the rate of death and myocardial

infarction observed in these studies was noted

in patients followed 18 months to 3 years after

stent implantation.

While the studies presented at the Atlanta and

Barcelona meetings have raised important

questions, the data we currently have do not

allow us to fully characterize the mechanism,

risks, and incidence of DES thrombosis. A

more formal cvaluation of the data in these

Studies is necessary, and any conclusions are

dependent upon a thorough peer review. FDA

intends to more formally evaluate the studies

presented in Atlanta and Barcelona.

At this time, FDA believes that coronary DES

remain safe and effective when uscd in

patients having clinical and coronary anatomic

features similar to those treated in the pivotal

trials conducted by the manufacturers for kK DA

approval. The approved indications are:

e The CYPHER Sirolimus-eluting Coronary

Stent is indicated for improving coronary luminal

3512004v.1

45a

diameter in patients with symptomatic ischemic

disease due to discrete de novo lesions of length < 30

mm in native coronary arteries with reference vessel

diameter of >2.5 mm to < 3.5mm.

e The TAXUS_ Express Paclitaxel-Eluting

Coronary Stent System is indicated for improving

luminal diameter for the treatment of de novo lesions

< 28 mm in length in native coronary arteries

>2.5mm to < 3.75 mm in diameter.

(Civ. No. 03-283-SLR, D.1. 522 at ex. G) As far as the court

knows, the Cypher and ‘Taxus stents are still on the market.

3. Analysis. Cordis argucs in its motion that

BSC should either dismiss the case or the court should grant

a new trial based on the "newly discovered" evidence

summarized above which, according to Cordis, demonstrates

conclusively that the Cypher topcoat is not a non-

thrombogenic material (or, at least, is evidence that a jury

should take into consideration in making its infringement

determination). The problem, of course, with Cordis’

argument is that the FDA has done no more than identify an

additional, medically acceptable, risk associated with the use

of DES (an increase in the rate of death and heart attack), has

opined that this risk is only “possibly due to stent

thrombosis," and has explained that it cannot “fully

characterize the mechanism, risks, or incidence of DES

thrombosis." (Civ. No. 03-283-SLR, D.1. 522 at ex. G)

(emphasis added) This "evidence" may well inflame a jury;

the question is whether it would inform a jury.

3512004y 1

4. The court concludes that the evidence

identified by Cordis is too speculative to warrant either a

dismissal or a new trial.°

Il IS FURTHER ORDERED that the Clerk of Court

enter judgment consistent with the jury verdicts returned in

these cases.

IT IS FURTHER ORDERED that the court will not

consider any further motion practice, by any party, in

connection with these cases until a final decision has been

issued by the United States Court of Appeals for the Federal

Circuit.

dan cP Kets

United States District Judge

° Even assuming that a causative relationship is established

between the "material" at issue in claim 8 of the '536 patent

and an increased msk of thrombosis, the court queries

whether, in the field of interventional cardiology (or in any

medical field), a drug that does not promote thrombosis in

the vast majority of the patient population (and which is

indicated for only this portion of the population) could be

medically or legally characterized as thrombogenic,

consistent with the court's claim construction.

47a

APPENDIX D

IN THE UNITED STATES DISTRICT COURT FOR

THE DISTRICT OF DELAWARE

CORDIS CORPORATION,

Plaintiff,

Vv.

Civ. No. 03-027-SLR

BOSTON SCIENTIFIC

CORPORATION and SCIMED

LIFE SYSTEMS, INC.,

Defendants.

Steven J. Balick, Esquire, John G. Day, Esquire and Tiffany

Geyer Lydon, Esquire of Ashby & Geddes, Wilmington,

Delaware. Counsel for Cordis Corporation. Of Counsel:

Gregory L. Diskant, Esquire, William F. Cavanaugh,

Esquire, Kim J. Landsman, Esquire, Eugene M. Gelernter,

Esquire, Thomas W. Pippert, Esquire, Kathleen M. Crotty,

Esquire, Scott W. Parker, Esquire, Rosa E. Son, Esquire,

Cathenne A. Williams, Esquire and Laura Storto, Esquire of

Patterson, Belknap, Webb & Tyler, LLP, New York, New

York, and Theodore B. Van Itallie, Esquire and Enric I.

Harris, Esquire of Johnson & Johnson, New Brunswick, New

Jersey.

Josy W. Ingersoll, Esquire, John W. Shaw, Esquire, Adam

W. Poff, Esquire, Glenn C. Mandalas, Esquire and Karen E.

Keller, Esquire of Young Conaway Stargatt & Taylor, LLP,

Wilmington, Delaware. Counsel for Boston Scientific

Corporation and Boston Scientific Scimed, Inc. Of Counsel:

John M. Desmarais, Esquire and Peter J. Armenio, Esquire of -

48a

Kirkland & Ellis, New York, New York. |

MEMORANDUM OPINION

Dated: May 11, 2006

Wilmington, Delaware

United States fave Judge

ROBINSON, Chief Judge

I. INTRODUCTION

On January 13, 2003, plaintiff Cordis Corporation

("Cordis") filed this patent infringement action against

defendants Boston Scientific Corporation and Scimed Life

Systems, Incorporated (collectively "BSC") alleging

infringement of U.S. Patent No. 4,739,762 ("the '762 patent")

by BSC's Express stent and other stents. (D.I. 1) On March

5, 2003, BSC answered and counterclaimed against Cordis,

denying that its stents infringe the '762 patent and alleging

that some of Cordis’ stents infringed U.S. Patent No.

5,922,021 ("the '021 patent"). (D.I. 26) On August 2, 2004,

Cordis filed an amended complaint alleging that BSC's

Liberté stent infringes the '762 patent and U.S. Patent No.

5,895,406 ("the '406 patent"). (D.1. 161) On August 18,

2004, BSC answered the amended complaint. (D.I. 163) A

jury trial was held from June 13, 2005 to June 20, 2005 on

the issue of Cordis’ claims of patent infringement against

BSC. On June 21, 2005, the jury returned a verdict that:

(1) the Express, Taxus Express, Express Biliary stents

(collectively, "the Express stents") and Liberté stents literally

infringe claim 23 of the '762 patent; (2) BSC has induced

literal infringement of claim | of the '762 patent with respect

to those stents; (3) the Liberté stent literally infringes claim 2

of the '406 patent; and (4) claim 2 of the '406 patent is neither

anticipated nor rendered obvious by the prior art. (D.I. 360)

A separate jury trial was held from June 21, 2005 to July 1,

2005 on the issue of BSC's claims of patent infringement

against Cordis. On July 1, 2005, the jury returned a verdict

that: (1) Cordis' Cypher stent infringes claim 8 of the '536

patent; (2)claim 8 of the '536 patent is not invalid for

obviousness; (3) Cordis’ Cypher, BX Velocity, BX Sonic and

Genesis stents do not literally intringe claim 36 of the '021

patent; (4) the Cypher, BX Velocity, BX Sonic and Genesis

stents infringe the "corners" limitation of claim 36 of the '021

patent under the doctrine of equivalents; and (5) claim 36 of

the '021 patent is not invalid for obviousness. (D.I. 381)

This court has jurisdiction pursuant to 28 U.S.C.

§ 1338. Pending before the court are: (1) BSC'’s renewed

motion for judgment as a matter of law of noninfringement

and invalidity; (2) BSC's motion for reconsideration of the

without prejudice aspect of the court's order dismissing

Cordis’ infringement claims against the Taxus Liberté stent;

and (3) Cordis' renewed motion for judgment as a matter of

law or, in the alternative, a new trial on infringement and

invalidity of the '021 patent. (D.I. 378, 382, 398)

Il. BACKGROUND

The disputes relate to expandable stents such as those

disclosed in the '762, '406 and '021 patents. Balloon

expandable stents and other types of stents are used to treat

diseased blood vessels in the heart and in other areas of the

body. A stent is a small device that holds open an artery just

like scaffolding inside a tunnel keeps the tunnel from

collapsing. At issue in this case are balloon expandable

stents which are used in conjunction with angioplasty

balloons. The stent is placed on a balloon and inserted into

an artery via a catheter. Once the balloon is at the area of

blockage, it is inflated, which causes the stent to expand and

press against the vessel wall, thereby opening the artery. The

balloon is then deflated and removed, leaving the expanded

stent in the artery to keep the vessel open and allow blood to

flow.

The '762 patent, entitled "Expandable Intraluminal

Graft, and Method and Apparatus for Implanting an

Expandable Intraluminal Graft," includes both apparatus and

method claims. The apparatus claims are directed to an

expandable tubular member that’ serves as_ vascular

scatfolding. The method claims of the '762 patent describe

the process of implanting the stent into a diseased vesscl.

The devices accused of infringing the '762 patent are the

Express, Taxus Express, Express Biliary and Liberté stents,

each of which is a balloon expandable stent.

The '406 patent, entitled "Axially Flexible Stent,"

includes several apparatus claims. These claims are directed

to a stent comprised of longitudinally disposed bands, where

each band defines a generally continuous wave, various links

maintain the bands in a tubular structure, and the links and

bands define an expandable structure having axial flexibility

in an unexpanded configuration. The device accused of

infringing this patent is the Liberté stent.

The ‘021 patent, entitled “Intravascular Stent," also

includes numerous apparatus claims. The apparatus claims at

issuc are directed to a stent comprising a first expansion strut

column, a second expansion strut column, and a first

connecting strut column. The device accused of infringing

the '021 patent is the BX Velocity stent, a balloon expandable

stent.

IIT. STANDARD OF REVIEW

A. Renewed Motion for Judgment as a

Matter of Law

BSC has renewed its motion for judgment as a matter

of law pursuant to Fed. R. Civ. P. 50(b). Cordis has also

renewed its motion for judgment as a matter of law. To

prevail on a renewed motion for judgment as a matter of law

following a jury trial, the moving party "'must show that the

jury's findings, presumed or express, are not supported by

substantial evidence or, if they were, that the legal

conclusion(s) implied [by] the jury's verdict cannot in law be

supported by those findings.'" Pannu v._Iolab Corp., 155

F.3d 1344, 1348 (Fed. Cir. 1998) (quoting Perkin-Elmer

Corp. v. Computervision Corp., 732 F.2d 888, 893 (Fed. Cir.

1984)). ‘Substantial’ evidence is such relevant evidence

52a

from the record taken as a whole as might be accepted by a

reasonable mind as adequate to support the finding under

review." Perkin-Elmer Corp., 732 F.2d at 893. In assessing

the sufficiency of the evidence, the court must give the

nonmoving party, “as [the] verdict winner, the benefit of all

logical inferences that could be drawn from the evidence

presented, resolve all conflicts in the evidence in his favor

and, in general, view the record in the light most favorable to

him." Williamson _v. Consol. Rail Corp., 926 F.2d 1344,

1348 (3d Cir. 1991); Perkin-Elmer Corp., 732 F.2d at 893.

The court may not determine the credibility of the witnesses

nor "substitute its choice for that of the jury between

conflicting elements of the evidence." Perkin-Elmer Corp.,

732 F.2d at 893. In sum, the court must determine whether

the evidence reasonably supports the jury's verdict. See

Dawn Equip. Co. v. Kentucky Farms Inc., 140 F.3d 1009,

1014 (Fed. Cir. 1998).

Likewise, in order to promote finality after trial, as

well as to preserve the historical function of the jury as the

trier of facts, the court "ought to grant a new trial on the basis

that the verdict was against the weight of the evidence only

where a miscarriage of justice would result if the verdict

were to stand." Williamson v. Consolidated Rai! Corp., 926

F.2d 1344, 1352 (3d Cir. 1991).

B. Motion for a New Trial

In the alternative to its motion for judgment as a

matter of law, BSC has moved for a new trial pursuant to

Fed. R. Civ. P. 59(a). Cordis has also moved for a new trial

as an alternative to its motion for judgment as a matter of

law. Federal Rule of Civil Procedure 59(a) provides, in

pertinent part:

A new trial may be granted to all or any of the

parties and on all or part of the issues in an

action in which there has been a trial by jury,

for any of the reasons for which new trials

have heretofore been granted in actions at law

in the courts of the United States.

Fed. R. Civ. P. 59(a). The decision to grant or deny a new

trial is within the sound discretion of the trial court and,

unlike the standard for determining judgment as a matter of

law, the court need not view the evidence in the light most

favorable to the verdict winner. See Allied Chem. Corp. v.

Darflon, Inc., 449 U.S. 33, 36 (1980); Olefins Trading, Inc.

v. Han Yang Chem. Corp., 9 F.3d 282 (1993); LifeScan Inc.

v. Home Diagnostics, Inc., 103 F. Supp.2d 345, 350 (D. Del.

2000) (citations omitted). See also 9A Wright & Miller,

Federal Practice and Procedure § 2531 (2d ed. 1994) ("Ona

motion for new trial the court may consider the credibility of

witnesses and the weight of the evidence."). Among the

most common reasons for granting a new trial are: (1) the

jury's verdict is against the clear weight of the evidence, and

a new trial must be granted to prevent a miscarriage of

justice; (2) newly-discovered evidence exists that would

likely alter the outcome of the trial; (3) improper conduct by

an attorney or the court unfairly influenced the verdict; or

(4) the jury's verdict was facially inconsistent. See Zarow-

Smith v. N.J. Transit Rail Operations, 953 F. Supp. 581, 584-

85 (D.N.J. 1997) (citations omitted). The court must proceed

cautiously, mindful that it should not simply substitute its

' Although BSC does not denominate its motion as one for a

new trial in the alternative, it argues in that motion that a new

trial should be granted if the court does not grant BSC's

motion for judgment as a matter of law.

54a

own judgment of the facts and the credibility of the witnesses

for those of the jury. Rather, the court should grant a new

trial on the basis that the verdict was against the weight of the

evidence only where a miscarriage of justice would result if

the verdict were to stand. See Williamson v. Consol. Rail

Corp., 926 F.2d 1344, 1352 (3d Cir. 1991); EEOC v. State of

Del. Dep't of Health and Soc. Servs., 865 F.2d 1408, 1413

(3d Cir. 1989).

C. Motion for Reconsideration

The purpose of a motion for reconsideration is to

"correct manifest errors of law or fact or to present newly

discovered evidence." Max's Seafood Café ex rel. Lou-Ann,

Inc. v. Quinteros, 176 F.3d 669, 677 (3d Cir. 1999).

Accordingly, a court may alter or amend a ruling if the

movant demonstrates at least one of the following: (1)a

change in the controlling law; (2) availability of new

evidence not available when the decision issued; or (3)a

need to correct a clear error of law or fact or to prevent

manifest injustice. See id.

IV. DISCUSSION

A. BSC's Renewed Motion for Judgment as

a Matter of Law of

Noninfringement and Invalidity

BSC moves for judgment as a matter of law or, in the

alternative, a new trial with respect to several issues:

(1) noninfringement of the '406 patent; (2) invalidity of the

'406 patent; and (3) noninfringement of the '762 patent. (D.I.

378)

1. Infringement of the '406 Patent

A determination of infringement requires a two-step

analysis. First, the court must construe the asserted claims so

55a

as to ascertain their meaning and scope. Second, the claims

as construed are compared to the accused product. See KCJ

Corp. v. Kinetic Concepts, Inc., 223 F.3d 1351, 1355 (Fed.

Cir. 2000). Claim construction is a question of law while

infringement is a question of fact. See id. To establish literal

infringement, "every limitation set forth in a claim must be

found in an accused product, exactly.". Southwall Tech., Inc.

v. Cardinal 1G Co., 54 F.3d 1570, 1575 (Fed. Cir. 1995). An

accused product that does not literally infringe a claim may

still infringe under the doctrine of equivalents if each

limitation of the claim is met in the accused product either

literally or equivalently. See Sextant Avionique, S.A. v.

Analog Devices, Inc., 172 F.3d 817, 826 (Fed. Cir. 1999),

Pursuant to its motion, BSC argues that the court

should grant judgment as a matter of law that the Liberté

stent does not infringe claim 2 of the '406 patent. (D.I. 402)

Alternatively, BSC argues that a new trial on the issue of

infringement is necessary. (Id.)

In support of its argument that the court should grant

judgment as a matter of law that the Liberté stent does not

infringe the '406 patent, BSC offers two arguments. First,

BSC argues that "Cordis improperly argued that a

combination of open space and metal forms the ‘wave’

required by claim 2 of the Gray '402 patent." (D.I. 402 at 5-

8) Secondly, BSC contends that "Cordis failed to introduce

any competent evidence that the metal of the Liberté stent

was a ‘wave’ under the court's claim construction." (D.I. 402

at 8-10)

At trial, Cordis argued that claim 2 of the '406 patent

was infringed by BSC's Liberté stent.2 BSC argues that the

* Claim 2 of the '406 patent depends from claim 1, which

reads in relevant part:

56a

Liberté stent does not infringe claim 2 because it does not

meet the "Wave" limitation of claim 2 as construed by the

court’ since Only metal surfaces can form the "wave"

structure. BSC cites to the cross-examination testimony of

Cordis’ expert, Dr, Buller, to suggest that "the metal surfaces

of the Liberté stent must form the claimed 'wave' in order for

there to be infringement." (D.1, 402 at 8, citing D.I. 366 at

699:4-24) BSC contends that Cordis' argument that the

Liberté stent infringes claim 2 because it has "circumferential

and longitudinal] 'springs"" is insufficient to meet the "wave"

A stent having first and second ends

with an intermediate section therebetween,

and a longitudinal axis, comprising:

a plurality of longitudinally disposed

bands, wherein each band defines a generally

continuous wave having a spatial frequency

along a lone segment parallel to the

longitudinal axis; .. .

'406 patent, col, 5, 11. 26-32. Claim 2 of the '406 patent

reads as follows:

A stent according to claim 1, wherein

each link is axially displaced from any

circumferentially adjacent link.

'406 patent, col, 5, 11. 40-41.

> ‘The "wave" limitation - "a plurality of longitudinally

disposed bands, wherein each band defines a generally

continuous wave having a spatial frequency along a lone

segment parallel to the longitudinal axis" - was construed by

the court to mean "the stent has multiple elongated surfaces

that run parallel to the stent's long axis, each of these surfaces

having the undulating appearance of a continuous wave."

(D.1. 334 at 2-3)

S7a

limitation and cannot prove infringement. (D.I. 402 at 8-9)

However, as Cordis correctly points out, the ‘406

specification refers to the "waves" as "springs" and notes that

they "provide the stent with . . flexibility." (D.I. 404 at 3,

citing '406 patent, col. 3, 1. 66 - col. 4, 1. 31) BSC contends

that "[t]he term ‘springs’ cannot serve as a surrogate for the

claim term '‘wave.'" Nevertheless, even if the evidence

offered by Cordis regarding "springs" were alone insufficient

to prove infringement, Dr. Buller also applied the court's

claim construction, premised on the term “wave", to suggest

that the Liberté stent infringed claim 2 of the '406 patent.

(D.1. 365 at 523:1-538:22) BSC next argues that, aside from

irrelevant testimony concerning "springs", Dr. Buller offered

"only conclusory assertions that the Liberté stent satisfied the

‘wave’ limitation." (D.I. 402 at 9, citing D.I. 365 at 526:15-

21, 527:13-19; D.l. 366 at 558:12-559:13) However, Dr.

Buller appears to have provided some context to his

assertions by explaining that the Liberté stent has a plurality

of longitudinal bands, that a longitudinal band of the Liberté

stent "fairly can be described as an undulating structure going

from end to end of the stent," and that each such band defines

a continuous wave under the court's construction. (D.I. 365

at $23:1-538:22; D.I. 366 at 725:3-7) Furthermore, Dr.

Buller addressed other limitations of claim 2 in explaining

that the links and wavy longitudinal bands in the Liberté

stent define "an expandable structure having axial flexibility

in an unexpanded configur ation," as required by claim 2.

(D.1. 365 at 531:18-532:7) In light of this evidence, a

reasonable jury could find that the Liberté stent infringes

claim 2 of the '406 patent. Therefore, the court shall deny

BSC's request for judgment as a matter of law that the

Liberté stent does not infringe claim 2 of the '406 patent.

As an alternative to its motion for judgment as a

matter of law, BSC argues that the court should order a new

trial on the issue of infringement. First, BSC contends that

the jury's verdict was against the weight of the evidence.

58a

(D.1. 402 at 10-11) Second, BSC maintains that "a new trial

is warranted because the disputed claim term 'wave' was not

construed." (D.1. 420 at 11-12)

In arguing that the jury's verdict was against the

weight of the evidence, BSC suggests that, while Cordis

provided only conclusory evidence that the Liberté stent met

the "wave" limitation of claim 2 of the '406 patent, BSC

provided “overwhelming evidence that the backtracking

metal of that stent could not possibly satisfy that limitation

under any proper construction of the term 'wave.'" (D.1. 402

at 10) However, BSC offered a similar argument at the claim

construction phase of trial, when it argued that "wave" should

be construed as a "naturally occurring waveform that cannot

backtrack along the longitudinal axis." (D.I. 230 at 29)

However, the court did not adopt such a construction, instead

construing the "wave" limitation to mean that "the stent has

multiple elongated surfaces that run parallel to the stent's

long axis, each of these surfaces having the undulating

appearance of a continuous wave." (D.I. 334 at 2-3) While

Dr. Moore testified as an expert for BSC that a structure such

as that of the Liberté stent which "loops back" on itself

cannot be a "wave" (D.1. 368 at 1185:81186:1), Dr. Buller

offered contrary testimony in suggesting that the bands of the

Liberté stent had an undulating structure which could be

viewed as a continuous wave (D.1. 365 at 523:1-538:22; D.1.

366 at 725:3-7). Based on the evidence offered at trial, the

jury was free to credit the testimony of Dr. Buller in finding

that the Liberté stent infringed claim 2 of the '406 patent.

BSC also argues that a new trial is warranted because

the court committed an error of law since the disputed claim

term "wave" was not explicitly construed. Specifically, BSC

contends that the court's construction of the “wavc"

limitation, “[ajlthough providing useful and necessary

guidance on other aspects of the 'wave' limitation, .. . did not

resolve one of the central disputes between the parties - what

59a

constitutes a ‘wave’ for purposes of Claim 2 of the Gray '406

patent." (D.1. 402 at 11) BSC cites Sulzer Textil A.G. v.

Picanol N.V., 358 F.3d 1356, 1366-67 (Fed. Cir. 2004), to

suggest that the court should have instructed the jury on the

meanings of all disputed terms used in the claims in suit and

that the court failed to do so when it “left the jury free to

make its own determination of the meaning of the claims."

(D.1. 402 at 11) As the Federal Circuit noted, "The jury must

be told that the court has made a claim construction ruling

that the jury must follow and cannot be left free to apply its

own reading of disputed terms to the facts of the case."

Sulzer Textil, 358 F.3d at 1366. In the case at issue, the

court met these requirements by advising the jury that the

"wave" limitation had been construed, specifically stating its

construction, and instructing the jury that it was obligated to

apply the court's construction to, inter alia, its infringement

analysis. (D.I. 369 at 1543:3-12, 1545:13-20, 1547:16-23)

Aside from the particular construction ascribed to the

wave limitation, BSC's contentions at tral appear

inconsistent with its argument that the term "wave" was not

construed by the court. First, BSC never suggested before or

during trial that the "wave" limitation had not been

construed. In fact, BSC consistently offered arguments at

trial to suggest that the court had construed that limitation,

although contending that the Liberté stent did not meet that

limitation, (D.1. 368 at 1175:10-1176:1, 1192:16-21; D.I.

369 at 1482:4-1490:5, 1488:15-16) As for BSC's argument

that the court's use of the phrase "surfaces having the

undulating appearance of a continuous wave" was not helpful

to the jury in understanding the wave limitation, BSC's own

proposed construction of the phrase “generally continuous

wave" in that limitation was "a_ naturally occurring

waveform.” (D.1. 230 at 29) BSC's further suggestion that

such a wavetorm “cannot have multiple circumferential

values at any single longitudinal location" (id.) was rejected

by the court in its construction. (D.1. 334 at 2-3) BSC

suggests neither how its proposed construction would have

provided any additional relevant understanding to the jury

regarding the asserted claim when compared with the

information provided under the court's construction, nor how

any such understanding would have been supported by

evidence to affect the verdict on infringement.

As its next assertion, BSC argues that the court's

claim construction left room for the jury to disagree on how

one of ordinary skill in the art would determine if the Liberté

stent met the wave limitation. (D.I. 402 at 11) BSC contends

that the jury was presented with various conflicting meanings

for the term "wave" at trial such that the jury could "choose

an erroneous construction and engage in a fatally-flawed

infringement analysis." (D.]. 402 at 11-12) However, these

arguments do not impact the appropriateness of the court's

claim construction. Claim construction alone cannot be

expected to resolve all infringement issues in a case. See

United States Surgical Corp. v. Ethicon, Inc., 103 F.3d 1554,

1567 (Fed. Cir. 1997) ("Markman explicitly recognized that

the application of the claim to the accused device [is] for the

jury."). Here, both parties offered expert testimony and other

evidence regarding whether the Liberté stent met the

limitations of claim 2 of the '406 patent and such evidence

provided substantial support for the verdict reached by the

jury as to infringement. As noted above, the court construed

the "wave" limitation and properly instructed the jury such

that no error was present. Thus, no new trial on the issue of

infringement is warranted.

2. Validity of the '406 Patent

A patent is presumed valid and the burden of proving

invalidity, whether under § 112 or otherwise, rests with the

challenger. See 35 U.S.C. 282. In order to overcome this

presumption, the party challenging validity bears the burden

of proving by clear and convincing evidence that the

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invention fails to meet the requirements of patentability. See

Hewlett-Packard Co. v. Bausch & Lomb, 909 F.2d 1464,

1467 (Fed. Cir. 1990). Clear and convincing evidence is

evidence that "could place in the ultimate factfinder an

abiding conviction that the truth of [the] factual contentions

are ‘highly probable."" Colorado v. New Mexico, 467 U.S.

310, 316 (1984).

Under 35 U.S.C. § 102(b), "[a] person shall be

entitled to a patent unless the invention was patented or

described in a printed publication in this or a forcign country

.. more than onc year prior to the date of the application for

patent in the United States." A claim is anticipated only if

each and every limitation as set forth in the claim is found,

either expressly or inherently described, in a single prior art

reference. Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d

628, 631 (Fed. Cir. 1987); Scripps Clinic & Research Found.

v. Genentech, Inc., 927 F.2d 1565, 1576 (Fed. Cir. 1991)

("There must be no difference between the claimed invention

and the reference disclosure, as viewed by a person of

ordinary skill in the field of the invention.").

An anticipation inquiry involves two steps. First, the

court must construe the claims of the patent in suit as a

matter of law. Key Pharms. v. Hercon Laboratories Corp.,

161 F.3d 709, 714 (Fed. Cir. 1998). Second, the finder of

fact must compare the construed claims against the prior art.

Id. A finding of anticipation will invalidate the patent.

Applied Med. Res. Corp. v. U.S. Surgical Corp., 147 F.3d

1374, 1378 (Fed. Cir. 1998).

In determining whether a patented invention is

explicitly anticipated, the claims are read in the context of the

patent specification in which they arise and in which the

invention is described. Glaverbel Societe Anonyme_v.

Northlake Mktg. & Supply, Inc., 45 F.3d 1550, 1554 (Fed.

Cir. 1995). The prosecution history and the prior art may be

consulted if needed to impart clarity or to avoid ambiguity in

ascertaining whether the invention is novel or was previously

known in the art. Id. The prior art need not be ipsissimis

verbis (i.e., use identical words as those recited in the claims)

to be anticipating. Structural Rubber Prods. Co. v. Park

Rubber Co., 749 F.2d 707, 716 (Fed. Cir. 1984).

A single prior art reference also may anticipate a

claim where one of ordinary skill in the art would have

understood each and every claim limitation to have been

disclosed inherently in the reference. Continental Can Co.

USA Inc. v. Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir.

1991). The Federal Circuit has explained that an inherent

limitation is one that is necessarily present and not one that

may be established by probabilities or possibilities. Id. That

is, "[t]he mere fact that a certain thing may result from a

given set of circumstances is not sufficient." Id. at 1269. The

Federal Circuit also has observed that “inherency operates to

anticipate entire inventions as well as single limitations

within an invention." Schering Corp. v. Geneva Pharms.

Inc., 339 F.3d 1373, 1380 (Fed. Cir. 2003). Moreover,

recognition of an inherent limitation by a person of ordinary

skill in the art before the critical date is not required to

establish inherent anticipation. Id. at 1377.

To establish that a patent claim is obvious, clear and

convincing evidence must exist to show that "the subject

matter as a whole would have been obvious at the time the

invention was made to a person having ordinary skill in the

art." 35 U.S.C. 103 (2003). The question of obviousness,

therefore, turns on four factual inquiries: (1) the scope and

content of the prior art; (2) the level of ordinary skill in the

art; (3) the differences between the claimed invention and the

prior art; and (4) any objective indicators of non-

obviousness, more commonly termed secondary

considerations. See Graham v. John Deere Co., 383 US. |,

17-18 (1966); B.F. Goodrich Co. v. Aircraft Braking Sys.

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Corp., 72 F.3d 1577, 1582 (Fed. Cir. 1996). The existence of

each limitation of a claim in the prior art does not, by itself,

demonstrate obviousness. Instead, there must be a "reason,

suggestion, or motivation in the prior art that would lead one

of ordinary skill in the art to combine the references, and that

would also suggest a reasonable likelihood of success."

Smiths Indus. Med. Sys., Inc. v. Vital Signs, Inc., 183 F.3d

1347, 1356 (Fed. Cir. 1999). "Such a suggestion or

motivation may come from the references themselves, from

knowledge by those skilled in the art that certain references

are of special interest in a field, or even from the nature of

the problem to be solved." Id. at 1356.

To rebut a prima facie case of obviousness based on

prior art, objective evidence of nonobviousness may be used.

Tec Air, Inc. v. Denso Mfg. Mich, Inc., 192 F.3d 1353, 1360

(Fed. Cir. 1999). This objective evidence includes: (1) a

long-felt and unmet need in the art for the invention; (2)

failure of others to achieve the results of the invention; (3)

commercial success of the invention; (4) copying of the

invention by others in the field; (5) whether the invention

was contrary to accepted wisdom of the prior art: (6)

expression of disbelief or skepticism by those skilled in the

art upon learning of the invention; (7) unexpected results; (8)

praise for the invention by those in the field; and (9)

independent invention by others. See Graham, 383 U.S. at

17-19. "The objective evidence of nonobviousness .

should when present always be considered as an integral part

of the analysis." Demaco Corp. v. F. Von Langsdorff

Licensing Ltd., 851 F.2d 1387, 1393 (Fed. Cir. 1988)

(quoting W.L. Gore & Assocs. Inc. v. Garlock, Inc., 721 F.2d

1540, 1555 (Fed. Cir. 1983), cert. denied, 469 U.S. 85!

(1984)).

The primary argument offered by KSC in support of

its motion 1s that the evidence at trial established that claim 2

of the '406 patent is invalid such that the court should grant

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judgment as a matter of law on this issue. (D.I. 399) In the

alternative to this argument, BSC urges the court to grant a

new trial on the validity of the '406 patent because the jury's

verdict was against the weight of the evidence. (Id.)

In support of its motion for judgment as a matter of

law that claim 2 of the '406 patent is invalid, BSC offers

three arguments: (1) it presented clear and convincing

evidence that the '762 patent discloses each and every

limitation of claim 2 of the '406 patent; (2) the only limitation

Cordis contested* is merely an inherent characteristic of the

claimed structure; and (3) even if deemed a structural

limitation, the '762 patent discloses "axial flexibility" under

the court's construction. (D.I. 399)

As part of its purported "clear and convincing"

evidence of invalidity, BSC cites to the testimony of Dr.

Moore, whom BSC claims stated that "the Palmaz '762 patent

discloses that the rectangular openings or 'slots’ shown in the

preferred embodiment can take a number of shapes,

including ‘elongated oval[s].'" (D.I. 399 at 7, citing D.1. 368

at 1196:16-1197:23) BSC argues that such an embodiment of

the '762 stent satisfies every limitation of claim 2 of the '406

patent under the court's claim construction. (D.I. 399 at 7-8)

BSC also contends that, at a minimum, "the Palmaz '762

patent renders Claim 2 of the Gray '406 patent obvious."

(D.1. 399 at 8, citing D.I. 368 at 1205:3-15) In contrast to the

assertions of BSC, Cordis maintains that, although Dr. Moore

described the '762 patent as having "some degree of

flexibility,” it was otherwise "universally recognized . . . as

being an ‘inflexible’ stent," as evidenced at trial. (D.I. 405 at

3-4, citing D.I. 364 at 200:19-24, 229:9-19; D.I. 365 at

* The limitation in dispute was the “axial flexibility"

limitation. The court construed "axial flexibility" to mean

"can bend or flex along its length." (D.I. 334 at 4)

410:9-412:2; D.I. 366 at 728:13-15; D.I. 368 at 1298:24-

1299:2, 1299:22-1300:15) Furthermore, Cordis cites to

evidence where Dr. Moore admitted that "in the .. . world of

stent designers," the "Palmaz stent" was known as "a rigid

stent." (D.1. 368 at 1298:24-1299:2) As Cordis pointed out,

Dr. Moore also conceded that the FDA-approved labeling for

that stent stated that the stent was "not flexible." (D.I. 368 at

1299:22-1300:15) In light of this evidence, the jury was

entitled to rely on the evidence that the stent of the '762

patent did not have "axial flexibility" such that it did not

anticipate or render obvious claim 2 of the '406 patent.

As its second argument in support of its motion for

judgment as a matter of law that claim 2 of the '406 patent is

invalid, BSC contends that the only limitation which Cordis

contested - the “axial flexibility" limitation’ - is merely an

inherent characteristic of the claimed structure such that the

'406 patent is anticipated by the '762 patent. (D.I. 399 at 8-

11) BSC relies, in part, on Harris Corp. v. Ixys Corp., 114

F.3d 1149, 1152 (Fed. Cir. 1997), to support this contention

and asserts that the Federal Circuit has held that "the 'such

that' clause at issue in that case ‘does nothing to limit the

scope of the claim’ because it ‘merely restates the basic

characteristic of the claimed structure." However, it does not

appear from the evidence that "axial flexibility” is a basic

characteristic of an unexpanded stent. For example, Cordis

has offered evidence that the "axial flexibility" limitation

“was added by amendment during prosecution to distinguish

Gray's ['406] claimed invention from the prior art." (D.I. 405

at 11) BSC has not offered clear and convincing evidence

that unexpanded stents have axial flexibility nor attempted to

> The text of the "axial flexibility" limitation at issue comes

from the final clause of claim 1 of the '406 patent, from

which claim 2 depends, and reads: "such that the links and

bands define an expandable structure having axial flexibility

in an unexpanded configuration."

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explain why, if that were true, an unexp

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