Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-cand-3_03-cv-03817/USCOURTS-cand-3_03-cv-03817-22/pdf.json

Nature of Suit Code: 830
Nature of Suit: Patent
Cause of Action: 28:1338 Patent Infringement

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United States District Court

For the Northern District of California

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NOT FOR PUBLICATION

IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF CALIFORNIA

EDWARDS LIFESCIENCES LLC, et al.,

Plaintiffs,

 v.

COOK INCORPORATED, and W.L. GORE

AND ASSOCIATES,

Defendants.

 /

No. C 03-03817 JSW

CLAIM CONSTRUCTION ORDER

INTRODUCTION

Plaintiffs Edwards Lifesciences LLC (“Edwards”) and Endogad Research PTY Limited

(“Endogad”) (collectively “Plaintiffs”) filed this suit alleging that Defendants, Cook

Incorporated (“Cook”) and W.L. Gore & Associates, Inc. (“Gore”) (collectively “Defendants”),

infringe U.S. Patent Nos. 6,582,458 (“the ‘458 Patent”), 6,613,073 (“the ‘073 Patent”),

6,685,736 (“the ‘736 Patent”), and 6,689,158 (“the ‘158 Patent”) (collectively the “patents-insuit”).

Pursuant to Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996), on March 14,

2007, the Court held a claim construction hearing to construe disputed claim terms from the

patents-in-suit. On June 28, 2007, the Court ordered supplemental briefing on whether

preamble terms should be construed. 

Having carefully considered the parties’ papers, including their supplemental briefs,

having heard the parties’ arguments, and having considered the relevant legal authorities, the

Court construes the disputed terms and phrases as set forth in the remainder of this Order.

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BACKGROUND

The patents-in-suit relate to devices for treating aneurysms, in particular abdominal

aortic aneurysms, and occlusive disease without resort to “open” surgery. (See Declaration of

Lisa A. Schneider in Support of Opening Claim Construction Brief (“Schneider Decl.”), Exs. 2,

12, 20, 21.) In this case, the patents-in-suit each are continuations of U.S. Patent No. 5,782,904

(“the ‘904 Patent”) and share a common specification. Further, each of the patents-in-suit claim

devices, or articles of manufacture, rather than methods, systems or processes. For purposes of

this Order, the Court sets forth the first claim of each of the patents-in-suit, which contain most,

but not all, of the disputed terms or phrases.

Claim 1 of the ‘458 Patent recites:

A prosthesis comprising:

(i) a bifurcated base structure which defines a common flow lumen

and a pair of connector legs which define divergent flow lumens from

the common flow lumen;

and

(ii) a graft which is adapted to be anchored within one of the flow

lumens of said bifurcated base structure to form a continuous

extension of that lumen.

(Schneider Decl., Ex. 2, ‘458 Patent, col. 6, ll. 12-19 (disputed claim terms emphasized).)

Claim 1 of the ‘158 Patent recites:

A prosthesis comprising:

a bifurcated base graft structure which defines a common flow lumen

and a pair of connector legs which define divergent flow lumens from

the common flow lumen; and

a second graft structure which is adapted to be anchored within one of

the flow lumens of said bifurcated base graft structure to form a

continuous extension of that lumen; and

wherein at least of one of the bifurcated base graft structure and the

second graft structure comprises a first end, a second end and a wire

member having at least a portion adjacent to the first end, the wire

member including a plurality of projecting apices, and wherein the

first end includes an edge which is scalloped between projecting

apices of the wire member.

(Schneider Decl., Ex. 12, ‘158 Patent, col. 6, ll. 14-29 (disputed claim terms emphasized).)

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Claim 1 of the ‘073 Patent recites:

A graft for treatment of aneurysms or occlusive diseases comprising:

a primary graft body, said primary graft body having a primary graft

flow lumen therethrough, said primary graft body having a first

portion and a second portion; and

a supplemental graft body, said supplemental graft body having a

secondary graft flow lumen therethrough, said supplemental graft body

comprising a first end and a second end, said first end of said

supplemental graft body being dockable to said second end of said

primary graft body while inside of a vessel to define a single flow

lumen which transfers substantially all blood flow between said

primary graft flow lumen and said secondary graft flow lumen.

(Schneider Decl., Ex. 20, ‘073 Patent, col. 6, ll. 43-57 (disputed terms emphasized).)

Claim 1 of the ‘736 Patent recites:

A graft comprising:

a first graft body, said first graft body having a first graft body inlet end

and a first graft body outlet end to define a flow passage therethrough; and

a second graft body, said second graft body having a second graft body

inlet end and a second graft body outlet end to define a flow passage

therethrough; 

said second graft body inlet end being attachable in an overlapping

relationship with said first graft body outlet end while inside of a vessel to

define a continuous flow passage through said first graft body inlet end,

said first graft body outlet end, said second graft body inlet end and said

second graft body outlet end.

(Schneider Decl., Ex. 21, ‘736 Patent, col. 6, ll. 14-26 (disputed claim terms emphasized).) 

ANALYSIS

A. Legal Standard.

“It is a bedrock principle of patent law that the claims of a patent define the invention

to which the patentee is entitled the right to exclude.” Innova/Pure Water, Inc. v. Safari Water

Filtration Sys., Inc., 381 F.3d 1111, 1115 (Fed. Cir. 2004). The interpretation of the scope and

meaning of disputed terms in patent claims is a question of law and exclusively within the

province of a court to decide. Markman, 517 U.S. at 372. The inquiry into the meaning of the

claim terms is “an objective one.” Innova/Pure Water, 381 F.3d at 1116. As a result, when a

court construes disputed terms, it “looks to those sources available to the public that show what

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a person of skill in the art would have understood the disputed claim language to mean.” Id. 

In most cases, a court’s analysis will focus on three sources: the claims, the specification, and

the prosecution history. Markman v. Westview Instruments, Inc., 52 F.3d 967, 979 (Fed. Cir.

1995) (en banc), aff’d, 517 U.S. 370 (1996). However, on occasion, it is appropriate to rely on

extrinsic evidence regarding the relevant scientific principles, the meaning of technical terms,

and the state of the art at the time at the time the patent issued. Id. at 979-81.

The starting point of the claim construction analysis is an examination of the specific

claim language. A court’s “claim construction analysis must begin and remain centered on the

claim language itself, for that is the language that the patentee has chosen to particularly point

out and distinctly claim the subject matter which the patentee regards as his invention.” 

Innova/Pure Water, 381 F.3d at 1116 (internal quotations and citations omitted). Indeed, in

the absence of an express intent to impart a novel meaning to a term, an inventor’s chosen

language is given its ordinary meaning. York Prods., Inc. v. Cent. Tractor Farm & Family

Center, 99 F.3d 1568, 1572 (Fed. Cir. 1996). Thus, “[c]laim language generally carries the

ordinary meaning of the words in their normal usage in the field of the invention.” Invitrogen

Corp. v. Biocrest Mfg., L.P., 327 F.3d 1364, 1367 (Fed. Cir. 2003); see also Renishaw v.

Marposs Societa’ per Azioni, 158 F.3d 1243, 1248 (Fed. Cir. 1998) (recognizing that “the

claims define the scope of the right to exclude; the claim construction inquiry, therefore,

begins and ends in all cases with the actual words of the claim”). A court’s final construction,

therefore, must accord with the words chosen by the patentee to mete out the boundaries of the

claimed invention.

The claims, however, do not stand alone. Thus, the written description, the drawings,

and, if included in the record, the prosecution history provide context and clarification

regarding the intended meaning of the claim terms. Teleflex, Inc. v. Ficosa N. Am. Corp., 299

F.3d 1313, 1324-25 (Fed. Cir. 2002). Rather, “they are part of ‘a fully integrated written

instrument.’” Phillips v. AWH Corp., 415 F.3d 1303, 1315 (Fed. Cir. 2005) (en banc) (quoting

Markman, 52 F.3d at 978). The specification “may act as a sort of dictionary, which explains

the invention and may define terms used in the claims.” Markman, 52 F.3d at 979. The

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specification also can indicate whether the patentee intended to limit the scope of a claim,

despite the use of seemingly broad claim language. SciMed Life Sys., Inc. v. Advanced

Cardiovascular Sys., Inc., 242 F.3d 1337, 1341 (Fed. Cir. 2001) (when the specification

“makes clear that the invention does not include a particular feature, that feature is deemed to

be outside the reach of the claims of the patent, even though the language of the claims, read

without reference to the specification, might be considered broad enough to encompass the

feature in question”). 

Intent to limit the claims can be demonstrated in a number of ways. For example, if the

patentee “acted as his own lexicographer,” and clearly and precisely “set forth a definition of

the disputed claim term in either the specification or prosecution history,” a court will defer to

that definition. CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). 

In order to so limit the claims, “the patent applicant [must] set out the different meaning in the

specification in a manner sufficient to give one of ordinary skill in the art notice of the change

from ordinary meaning.” Innova/Pure Water, 381 F.3d at 1117. In addition, a court will adopt

an alternative meaning of a term “if the intrinsic evidence shows that the patentee

distinguished that term from prior art on the basis of a particular embodiment, expressly

disclaimed subject matter, or described a particular embodiment as important to the invention.” 

CCS Fitness, 288 F.3d at 1367. Likewise, the specification may be used to resolve ambiguity

“where the ordinary and accustomed meaning of the words used in the claims lack sufficient

clarity to permit the scope of the claim to be ascertained from the words alone.” Teleflex, 299

F.3d at 1325.

However, limitations from the specification (such as from the preferred embodiment)

may not be read into the claims, absent the inventor’s express intention to the contrary. Id. at

1326; see also CCS Fitness, 288 F.3d at 1366 (“[A] patentee need not ‘describe in the

specification every conceivable and possible future embodiment of his invention.’”) (quoting

Rexnord Corp. v. Laitram Corp., 274 F.3d 1336, 1344 (Fed. Cir. 2001)). To protect against

this result, a court’s focus should remain on understanding how a person of ordinary skill in the

art would understand the claim terms. Phillips, 415 F.3d at 1323.

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If the analysis of the intrinsic evidence fails to resolve any ambiguity in the claim

language, a court then may turn to extrinsic evidence, such as expert declarations and

testimony from the inventors. Intel Corp. v. VIA Techs., Inc., 319 F.3d 1357, 1367 (Fed. Cir.

2003) (“When an analysis of intrinsic evidence resolves any ambiguity in a disputed claim

term, it is improper to rely on extrinsic evidence to contradict the meaning so ascertained.”)

(emphasis in original). When considering extrinsic evidence, a court should take care not to

use it to vary or contradict the claim terms. Rather, extrinsic evidence is relied upon more

appropriately to assist in determining the meaning or scope of technical terms in the claims. 

Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583-84 (Fed. Cir. 1996).

Dictionaries also may play a role in the determination of the ordinary and customary

meaning of a claim term. In Phillips, the Federal Circuit reiterated that “[d]ictionaries or

comparable sources are often useful to assist in understanding the commonly understood

meanings of words....” Phillips, 415 F.3d at 1322. The Phillips court, however, also

admonished that district courts should be careful not to allow dictionary definitions to supplant

the inventor’s understanding of the claimed subject matter. “The main problem with elevating

the dictionary to ... prominence is that it focuses the inquiry on the abstract meaning of the

words rather than on the meaning of claim terms within in the context of the patent.” Id. at

1321. Accordingly, dictionaries necessarily must play a role subordinate to the intrinsic

evidence.

In addition, a court has the discretion to rely upon prior art, whether or not cited in the

specification or the file history, but only when the meaning of the disputed terms cannot be

ascertained from a careful reading of the public record. Vitronics, 90 F.3d at 1584. Referring

to prior art may make it unnecessary to rely upon expert testimony, because prior art may be

indicative of what those skilled in the art generally understood certain terms to mean. Id. 

B. Claim Construction.

The parties dispute the meaning of twelve claim terms or phrases culled from each of

the patents-in-suit. The parties’ proposed constructions are set forth in an Appendix to this

Order, and the key differences are summarized herein.

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1 The term “prosthesis” is found in the preamble of independent claim 1 of the

‘458 Patent and in each of the dependent claims of that patent. The term “prosthesis” also is

found in the preamble to independent claims 1, 15, 17 and 23 of the ‘158 Patent and in each

of the dependent claims of that patent. The term “prosthesis” also is found in the bodies of

dependent claim 22 and independent claim 23 of the ‘158 Patent. 

The term “graft” is found in the preamble of independent claim 1 of the ‘073 Patent

and is found in the preamble of independent claims 1, 20, 21 and 23 of the ‘736 Patent. It

also is found in each of the dependent claims of those patents. 

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1. “Prosthesis” and “Graft”1

The parties ask the Court to construe the terms “prosthesis” and “graft,” as those terms

are used in the preambles to asserted claims. “Whether to treat a preamble as a claim

limitation is determined on the facts of each case in light of the claim as a whole and the

invention described in the patent.” Storage Technology Corp. v. Cisco Systems, Inc., 329 F.3d

823, 831 (Fed. Cir. 2003) (citing Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d

801, 808 (Fed. Cir. 2002)). A preamble “generally limits the claimed invention if it ‘recites

essential structure or steps, or if it is necessary to give life, meaning, and vitality to the claim.’” 

NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282, 1305 (Fed. Cir. 2005) (quoting Catalina

Mktg. Int’l, 289 F.3d at 808); see also Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332,

1339 (Fed. Cir. 2003) (“When limitations in the body of the claim rely upon and derive

antecedent basis from the preamble, then the preamble may act as a necessary component of

the claimed invention.”); C.R. Bard, Inc. v. M3 Sys., Inc., 157 F.3d 1340, 1350 (Fed. Cir. 1998)

(“[A] preamble usually does not limit the scope of the claim unless the preamble provides

antecedents for ensuring claim terms and limits the claim accordingly.”). If, however, the

preamble merely “serves as a convenient label for the invention as a whole,” and the body of

the claim sets out the complete invention, a preamble term will not limit the scope of the

claims. Storage Technology, 329 F.3d at 831; Bristol-Meyers Squibb Co. v. Ben Venue Labs,

Inc., 246 F.3d 1368, 1373-74 (Fed. Cir. 2001) (citing Pitney Bowes, Inc. v. Hewlett-Packard

Co., 182 F.3d 1298, 1305 (Fed. Cir. 1999)).

In general, these terms are used only in the preambles to independent claims. (See ‘458

Patent, claim 1; ‘073 Patent, claim 1; ‘736 Patent, claims 1, 20, 22; and ‘158 Patent, claims 1,

15, and 17.) These terms also are used in dependent claims, prior to the introduction of

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additional limitations. (See, e.g., ‘458 Patent, claim 2 (“The prosthesis as defined in claim 1,

wherein said bifurcated base structure is circumferentially reinforced at locations along its

length by a plurality of separate spaced apart wires.”) The bodies of the independent claims,

which use the terms solely in their preamble, set out a complete invention that is not dependent

upon the preamble term for life, meaning or vitality. Further, because the bodies of these

independent claims do not use the terms “prosthesis” or “graft,” they do not “derive antecedent

basis from the preamble.” See Eaton, 323 F.3d at 1339. 

Cook argues that because the terms “prosthesis” and “graft” are used in dependent

claims, the terms in those claims must derive their antecedent basis from the independent

claims. The Court does not find this argument persuasive, as it effectively negates the

principle that a preamble term may serve merely as a label for the invention as a whole. Thus,

the Court concludes that with respect to claim 1 of the ‘458 Patent, claim 1 of the ‘073 Patent,

claims, 1, 20 and 22 of the ‘736 Patent, and claims 1 and 15 of the ‘158 Patent, the terms

“prosthesis” and “graft,” are labels for the invention as a whole and need not be construed. 

However, independent claim 21 of the ‘736 patent, and independent claim 23 and

dependent claim 22 of the ‘158 Patent, which depends from independent claim 17 of that

patent, use the terms “prosthesis” or “graft” in both the preamble and the body of the claims. 

In the Catalina Mktg. case, supra, the district court determined that a term used solely in a

preamble of one claim and in the preamble and body of another claim should be construed as a

limitation in both claims. The Federal Circuit reversed. With respect to the claim that used the

term only in the preamble, the court held that the term was not a limitation because: “the

applicant did not rely on this phrase to define its invention nor is the phrase essential to

understand limitations or terms in the claim body[;]” the specification did show that the term

provided additional structure for the invention described in the body of the claim; the inventors

had not relied on the term to distinguish over prior art; and because if the disputed phrase was

deleted from the preamble, it would not affect the fact that the claim body defined a

structurally complete invention. Catalina Mktg., 289 F.3d at 810. As to the claim where the

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2 The claim language demonstrates that the claimed “prosthesis” or “graft” is

comprised of several components, i.e. a bifurcated base graft structure and a second graft

structure, or a first graft body and a second graft body. The Court, therefore, concludes it is

not necessary to include “multi-component” in its construction of these terms. 

3 Because the patents-in-suit share a common specification, for ease of

reference, the Court’s citations to the specification in this Order are to the ‘458 Patent. The

only time the term “prosthesis” appears in the specification is in the title of an article cited in

the section of the specification describing the Background Art. (See, e.g., ‘458 Patent, col. 1,

ll. 22-24.) Defendants urge the Court to adopt their construction of the term “prosthesis,”

primarily based upon the language in the specification that refers to “the invention” as an

“intraluminal graft.” That is, Defendants essentially equate the term “prosthesis,” as used in

the preamble to claims of the ‘458 and ‘158 Patents, to the term “graft,” as used in the

preambles to claims of the ‘736 Patent and ‘073 Patent. Plaintiffs do not seem to seriously

dispute this proposition and do not articulate a clear difference between the two terms, other

than to argue that the term “graft” should include a requirement that it be formed in part of

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term was used both in the preamble and the body, the Federal Circuit affirmed the district

court’s construction of the term as a limitation, because the term as used in the body derived

antecedent basis from the preamble. Id. at 810-11. In this case, in those claims where the

inventors chose to use the terms “prosthesis” and “graft,” in the preamble and the bodies of

claims, the Court concludes that the preamble does provide an antecedent basis for the terms as

used in the body and, therefore, acts as a limitation for those terms. 

Defendants assert that the Court should construe the terms “prosthesis” and “graft” to

mean an intraluminal device. Plaintiffs argue that the terms should be construed more broadly

and can encompass a device comprised in part of a traditional vascular graft. Gore also argues

the Court should construe these terms as “multi-component” devices “used as a unit.”2

The Court first looks to the language of the claims. Claim 21 of the ‘736 Patent refers

to overlapping or attaching one portion of the “graft” to the second portion of the “graft,” while

it is inside of a vessel. (‘736 Patent, col. 7, ll. 36-38.) As is discussed in more detail below,

Claims 22 and 23 of the ‘158 Patent refer to the “prosthesis” being placed in a vessel. Thus,

the language of these claims support Defendants’ position that the terms should be construed to

be limited to intraluminal devices. 

The Court also considers the claim language in light of the specification of which it is a

part. See Markman, 52 F.3d at 979. The specification shows that the inventors use the term

“graft” as shorthand for “intraluminal graft.”3

 For example, in the “Field of the Invention”

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plastic or polymer. 

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section, the inventors state that “[t]he present invention relates to an intraluminal graft for use

in treatment of aneurysms or occlusive disease.” (‘458 Patent, col. 1, ll. 10-11.) In the section

entitled “Background Art,” the inventors state that “[i]t is known to use “stents and

intraluminal grafts of various designs for the treatment of aneurysms ... .” (Id., col. 1, ll. 15-

16.) The inventors discuss the prior art intraluminal grafts and then state that “[s]uch

intraluminal grafts are inserted through the femoral artery into the aorta in a catheter. Upon

release of the graft from the catheter it expands to the size of the aorta[.] ... There are a number

of problems associated with such known grafts.” (Id., col. 1, ll. 27-33 (emphasis added).) The

inventors conclude by stating that “[t]he present invention is directed to an alternative form of

intraluminal graft which provides an alternative to known grafts.” (Id., col 1., ll. 40-42

(emphasis added).) See Honeywell Int’l, Inc. v. ITT Indus., Inc., 452 F.3d 1312, 1318 (Fed.

Cir. 2006) (“On at least four occasions the written description refers to the fuel filter as ‘this

invention’ or ‘the present invention.’”).

Similarly, in the section entitled “Disclosure of the Invention,” the inventors state that

“[i]n another aspect the invention relates to a method for positioning an intraluminal graft as

defined above ... causing an intraluminal graft as defined above to be carried through the

catheter on an inflatable balloon until the graft extends into the vessel from the proximal end

of the catheter ... .” (Id., col. 1, ll. 54-59 (emphasis added).) In addition, in the section entitled

“Best Mode of Carrying Out the Invention,” the inventors use the terms “intraluminal graft 10”

and “graft 10” interchangeably. (See, e.g., id. at col. 5, ll. 11, 17, 21, 26-27, 58-67, col. 6, ll. 1-

10.) Finally, the specification is rife with references to the “intraluminal graft” or, the

shorthand “graft”, as “the invention” or “this invention.” (See, e.g., id., col. 1, ll. 11-12, 40-41,

45-46, col. 3, ll. 33, 39-40, 45, col. 4, ll. 5-6, 20, 32, 55-56.) 

Finally, each of the alternative embodiments described in the specification refer to

devices that contain wires, which all parties agree are a feature of intraluminal grafts. None of

the alternative embodiments, however, describe a traditional vascular graft. Nor do any of the

figures disclose a traditional vascular graft. These facts further support Defendants’ argument

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that the terms “prosthesis” and “graft” should be limited to intraluminal devices. (See, e.g.,

‘458 Patent, col. 3, ll. 26-32 & Figs. 1-7.) 

Plaintiffs rely on declarations submitted during the prosecution history to support their

position that the terms “prosthesis” and “graft” should not be so limited. (See Schneider Decl.,

Exs. 4-8.) These declarations describe a surgery that Dr. White performed, on October 6,

1993, in which he overlapped an intraluminal graft with a traditional vascular graft, using what

Plaintiffs’ describe as the “Sydney Trombone Technique.” With respect to the term

“prosthesis,” Plaintiffs also rely on the fact that a dictionary definition of the term “prosthesis,”

which comports with their proposed construction, is attached to the Declaration of Dr. Ian

Gordon. (See Schneider Decl., Ex. 7.) However, a fair read of Dr. Gordon’s declaration

supports Defendants’ position. In that declaration, Dr. Gordon did not refer back to the

traditional vascular graft when he explained the meaning of the term “prosthesis.” He referred

back to the endovascular grafts. (Schneider Decl., Ex. 7 at 2 (“[E]ach endovascular graft is a

prosthesis....”) (emphasis added).) Thus, although the language of the claims, read without

reference to the specification, might be broad enough to encompass a non-intraluminal

prosthesis or graft, when the Court reads the claims in light of the specification, it concludes

that a person of ordinary skill in the art would understand that the inventors used the terms

“prosthesis” and “graft” in these claims to claim intraluminal devices. See SciMed Life Sys.,

Inc., 242 F.3d at 1341. 

The language of claim 21 of the ‘736 Patent, and the language of claims 22 and 23 of

the ‘158 Patent also support Gore’s position that the “prosthesis” or “graft” should be

construed to require that the device is used in a unitary fashion. For example, dependent claim

22 of the ‘158 Patent teaches that “the prosthesis is adapted to be placed in a lumen of a first

vessel that intersects with a second vessel....” (‘158 Patent, col. 8, ll. 1-2.) Similarly,

independent claim 23 reads as follows:

A prosthesis comprising:

a bifurcated base graft structure which defines a common flow lumen and

a pair of connector legs which define divergent flow lumens from the

common flow lumen; and

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a second graft structure which is adapted to overlap and be attached to one

of the flow lumens of said bifurcated base structure [sic] to form a

continuous extension of that lumen; 

wherein at least one of the bifurcated base graft structure and the second

graft structure comprises a first end and a second end, and wherein at least

one of the first and second ends is provided with a wire structure which

has a plurality of apices extending beyond at least a portion of the

corresponding end such that the wire structure apices extend across a

lumen of a first vessel that opens into a second vessel in which the

prosthesis is being placed without occluding the lumen of said first vessel.

(Id., col. 8, ll. 17-36 (emphasis added).) Independent claim 21 of the ‘736 Patent contains

language that is similar to the “wherein clause” of claim 23 of the ‘158 Patent. (See ‘736

Patent, col. 8, ll. 3-13 (“wherein the graft is adapted to be placed in a lumen of a first vessel

that intersects with a second vessel; and wherein at least one of the said inlet end of said first

graft body and said outlet end of said second graft body that is adjacent to a junction between

the first vessel and the second vessel is reinforced with a wire member which has a plurality of

apices extending beyond at least a portion of said respective end adjacent to said junction, and

said plurality of apices extend across said junction so that the graft does not occlude the lumen

of the second vessel”) (emphasis added).)

The inventors specifically define the term vessel in the specification as “blood vessels

or like ducts such as the bile duct and the ureter.” (See ‘458 Patent, col. 1, ll. 18-20.) Thus,

the claim language emphasized above, when combined with the inventors’ explicit definition

of vessel, supports a conclusion that the inventors intended that both portions of the

“prosthesis” or “graft” described in these claims would be used in a unitary fashion. This

claim language therefore undercuts Plaintiffs’ argument that the “prosthesis” or “graft”

claimed could be comprised, in part, of a device that already had been implanted in a patient.

Accordingly, the Court construes the terms “graft,” as used in claim 21 of the ‘736

Patent, and the term “prosthesis,” as used in claims 17, 22 and 23 of the ‘158 Patent, to mean:

“An intraluminal device that is used in unitary fashion to substitute, repair or replace a

missing or defective part of a vessel.”

//

//

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4 The term “bifurcated base structure” is found in independent claim 1 of the

‘458 Patent. The parties ask the Court to construe this term and the term “bifurcated base

graft structure,” found in independent claims 1, 15, 17 and 23 of the ‘158 Patent in the same

manner. 

5 Plaintiffs also propose a construction that includes a requirement that the

“bifurcated base structure” permits the “connection of additional grafts.” The Court

concludes that this feature of the “bifurcated base [graft] structure” is addressed by the

manner in which the Court construes the term “a pair of connector legs.”

13

2. “Bifurcated Base Structure” and “Bifurcated Base Graft Structure”4

The parties agree that the “bifurcated base [graft] structure” is divided at its

downstream end. Cook argues that it must be “trouser” shaped. Plaintiffs and Gore argue it is

either “Y-shaped” or “forked.”5

 The primary dispute between the parties is whether this term

should be construed to mean that the “bifurcated base [graft] structure” is an intraluminal

device that contains malleable wires. 

Plaintiffs support their position that the “bifurcated base [graft] structure” is not limited

to intraluminal devices by reference to the declarations submitted during the prosecution

history, which describe the October 6, 1993 surgical procedure. Plaintiffs argue that these

declarations refer to an “aorto-iliac bypass graft,” which previously had been implanted in the

patient during open surgery. Plaintiffs equate that aorto-iliac bypass graft to the “bifurcated

base [graft] structure” as used in the claims. Plaintiffs also argue that because claim 1 of the

‘158 Patent provides that “at least one” of the bifurcated base graft structure or the second graft

structure has a wire member, the Court should not construe “bifurcated base [graft] structure”

to require wires in all instances. Defendants, in contrast, argue that the specification does not

support a construction of the term “bifurcated base [graft] structure” that could include a

traditional surgical graft, i.e. a graft without wires. Defendants also argue that the specification

demonstrates that the inventors disclaimed resilient wires. 

Defendants’ arguments do find support in the specification. For example, in the

sections of the specification that describe a bifurcated device, the inventors state that when an

aneurysm is located near a bifurcated artery, “it is possible to place a graft according to the

present invention which has a bifurcation at its downstream end, a so-called ‘trouser-graft’,

wholly within the primary artery.” (‘458 Patent, col. 4 ll. 18-23 (emphasis added).) That

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section of the specification continues, “[i]n the case of an aneurysm in the aorta, for instance,

that extended into each of the iliac arteries the primary graft of the ‘trouser’ type would be

placed in the aorta through one of the iliac arteries.” (Id., col. 4, ll. 25-29 (emphasis added).) 

These references suggest that the device in question is placed intraluminally and is not a

bifurcated device already implanted in a vessel. 

Further support for Defendants’ position is found in the section of the specification in

which the inventors state that one leg of a trouser graft “will have a skirt which cannot be

expanded by a balloon catheter.” (Id., col. 4, ll. 45-49.) This language again suggests that the

“bifurcated base [graft] structure” of the claims would not encompass a traditional vascular

graft. In addition, the prosecution history of the ‘158 Patent shows that when the inventors

added the “bifurcated base graft structure” language to the claims, they referred to the portions

of the specification, cited above, that describes a bifurcated device as support for that claim

language. (See Prosecution History of ‘158 Patent, 37 CFR 1.111 Amendments dated Aug. 11,

2003 and October 30, 2003, Inventors Remarks and Support Chart.)

Plaintiffs also rely on the doctrine of claim differentiation to support their position that

the “bifurcated base [graft] structure” could encompass a traditional vascular graft. Thus, by

way of example, Plaintiffs argue that because dependent claim 2 of the ‘458 Patent recites a

prosthesis “wherein said bifurcated base structure is circumferentially reinforced at locations

along its length by a plurality of separate spaced apart wires,” the Court should not construe

the term as used in independent claim 1 of that patent to require wires. (Compare ‘458 Patent,

col. 6, ll. 12-19, with id., col. 6, ll. 20-23.) 

In general, the doctrine of claim differentiation recognizes “that different words or

phrases used in separate claims are presumed to indicate that the claims have different

meanings and scope.” Andersen Corp. v. Fiber Composites, LLC, 474 F.3d 1361, 1369 (Fed.

Cir. 2007) (quoting Karlin Tech. Inc. v. Surgical Dynamics, Inc., 177 F.3d 968, 971-72 (Fed.

Cir. 1999)). Thus, there is a presumption that “[t]o the extent the absence of such difference in

meaning and scope would make a claim superfluous, ... the difference between claims is

significant.” Id. (quoting Tandon Corp. v. U.S. Int’l Trade Comm’n, 831 F.2d 1017, 1023

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(Fed. Cir. 1987)). That presumption may be overcome, however, by the written description of

the patent or its prosecution history. Id. 

Defendants argue that claim 1 of the ‘458 Patent would not be rendered superfluous if

the Court were to adopt their construction, because the dependent claims of that patent contain

other limitations, such as “circumferentially reinforced at locations along its length.” Indeed,

dependent claim 11 of the ‘458 Patent provides that “said graft is circumferentially reinforced

at locations along its length by a plurality of separate spaced apart wires.” This language

refers back to the “graft which is adapted to be anchored within one of the flow lumens,”

limitation of independent claim 1, which appears in the second portion of the body of the

claim. Plaintiffs, however, argue that it is the second portion of the bodies of the asserted

claims that incorporate the intraluminal limitation. Thus, under Plaintiffs’ theory, the

“circumferentially reinforced” language must be an additional limitation. Furthermore, when

the Court views the term “bifurcated base [graft] structure” in light of the references in the

specification that describe a bifurcated device, the Court does not find Plaintiffs’ claim

differentiation argument persuasive. (See ‘458 Patent, col. 4, ll. 18-23, 25-29, 45-49.) 

Plaintiffs also propose a construction that would equate this term merely to a

foundation. The term “base,” however, implies that this portion of the device serves as a

foundation. Therefore, the Court concludes that something additional is required to give

meaning to the word structure. The Court concludes that the reinforcing wires give meaning to

that word and, thus, agrees with Defendants that the term should be 

construed to include wires. 

Finally, the Court concludes that the inventors disclaimed self-expanding wires in the

specification. The inventors describe prior art intraluminal grafts as being comprised of “a

sleeve in which is disposed a plurality of self expanding wire stents.” (‘458 Patent, col. 1, ll.

20-22.) They then state that “[t]here are a number of problems associated with such known

grafts,” including the “lack of precise control of the expansion of the graft in the lumen.” The

inventors then state that their invention is “directed to an alternative form of intraluminal grafts

which provides an alternative to the known grafts.” (Id., col. 1, ll. 32-42.) Thereafter, the

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28 6 This term is found in independent claim 1 of the ‘458 Patent and is found in

independent claims 1, 15, 17, and 23 of the ‘158 Patent.

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inventors describe the wires that form part of the invention as malleable or state that the device

is expanded by use of balloons. (See, e.g., id., col. 1, ll. 49, 60-63, col. 2, ll. 8-15, col. 3, ll. 8-

10, col. 5, ll. 32-36, 58-60, 66-67, col. 6, ll. 5-7.) Thus, when the Court reads the claims in

light of the specification, it concludes that a person of ordinary skill in the art would clearly

understand that this invention requires malleable, rather than resilient, wires. 

Accordingly, the Court construes the terms “bifurcated base structure” and “bifurcated

base graft structure” to mean: “An intraluminal graft that has one opening at its upstream

end and two openings at its downstream end and which includes at least one malleable

wire.”

3. “A Pair of Connector Legs”6

The parties agree that the downstream end of the bifurcated base [graft] structure has

two branches and that the term “a pair of connector legs” refers to those branches. The

primary dispute is whether the word “pair” means identical. 

The claim language is silent. The specification provides some guidance on the meaning

of the term, because the inventors refer to “a graft according to the present invention which has

a bifurcation at its downstream end, a so-called ‘trouser graft.’” (‘458 Patent, col. 4, ll. 20-22;

see also id., col. 4, ll. 45-49 (“This latter arrangement is particularly suitable in the case of

‘trouser grafts’ wherein one leg of the graft will have a skirt which cannot be expanded by a

balloon catheter.”).) Cook argues that the reference to “trouser grafts” demonstrates that the

term “pair” must mean something of equal length, because trousers have legs that are the same

length. Cook supports that definition by reference to a dictionary definition in which “pair” is

defined as “two things equal.” (See Cook Ex. 14.) 

The word “pair” also means “two corresponding things designed for use together” or

“something made up of two corresponding pieces (a – of trousers).” These definitions of the

word, however, do not necessarily require a pair to be “equal” in all respects. See Webster’s

Ninth New Collegiate Dictionary at 847 (1987); id. at 293 (definition of corresponding:

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“having or participating in the same relationship (as kind, degree, position, correspondence, or

function)). Thus, apart from the reference to “trouser grafts,” neither the specification nor the

prosecution history provide clear support for Defendants’ proposed construction.

Gore also argues that the construction of the term should also include the requirement

that each of the connector legs “has an opening for connecting to a graft adapted to be

anchored within the branch.” (Gore Br. at 14:21-23.) The Court agrees with Gore on this

point. The word “connector” is an adjective for the verb “connect,” which means “to become

joined,” or “to join or fasten together ... by something intervening” or “to place or establish in

relationship.” See, e.g., Webster’s Ninth New Collegiate Dictionary at 278. Support for

incorporating a connection function in the construction of the term “a pair of connector legs,”

also is supported by the specification. The inventors state therein that supplemental grafts can

be introduced to overlap or dock, i.e. connect to or with, the ends of a bifurcated device. (‘458

Patent, col. 4, ll.18-32.) 

Accordingly, the Court construes the term “a pair of connector legs” to mean: “The

two branches at the downstream end of the bifurcated base [graft] structure, each of

which has an opening to which an additional graft may be connected.” 

4. “Graft Body”7

The primary dispute among the parties with respect to this term is whether the graft

body contains malleable wires. The claim language again is silent. However, the specification

supports Plaintiffs’ position that the graft body does not include wires. Indeed, throughout the

specification, when the inventors refer to the “graft” or “intraluminal graft,” they distinguish

between the material of which the graft body can be composed and the wires. (See, e.g.,‘458

Patent, col. 3, ll. 8-25 (“If the graft body is of a woven material the wires may be interwoven

with the graft body.”).) The specification also contains a lengthy discussion of the graft body

that distinguishes the graft body from the wires and suggests that the wires may be integrated

with the graft body or attached to it by some other means. Again, this discussion supports a

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8 The term “graft which is adapted to be anchored within on of the flow

lumens” is found in independent claim 1 of the ‘458 Patent. The term “graft structure which

is adapted to be anchored within one of the flow lumens” is found in independent claim 1 of

the ‘158 Patent. 

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view that the graft body is separate and distinct from the wires. (See id., col. 2, ll. 62-67, col.

3, ll. 1-25.) Finally, when they discuss the prior art, the inventors note that intraluminal grafts

previously had been formed of a “sleeve, in which is disposed a plurality of self-expanding

wire stents.” (Id., col. 1, ll. 20-22.) These references further reinforce the view that the “graft

body,” or sleeve, is separate from the wires or wire-stents.

Accordingly, the Court construes the term “graft body” to mean: “an artificial device

formed of plastic or fabric for use inside of a vessel.”

5. “Graft which is adapted to be anchored within one of the flow lumens” and

“Graft structure which is adapted to be anchored within one of the flow

lumens”8

Because the parties requested that the Court construe the term “graft,” as used in the

preamble of the claims but not the bodies of claims, the Court inquired of the parties whether

the crux of the dispute over this phrase, and other similar phrases, was with respect to the

“adapted to be anchored within” language. Plaintiffs argued it was. Defendants argued it was

not and argued that the Court must construe the entire phrase. Defendants also argued that the

phrase, as with their proposed construction of the term “graft,” should be construed to be an

intraluminal device. The Court concludes this phrase should be construed to require an

intraluminal limitation. Although the word “graft” is followed by a “which” clause, that clause

does not fully elaborate on the meaning of the word graft. As set forth above in Section B.1,

the specification demonstrates how the inventors defined the word “graft.” 

Although the parties disagree on the intraluminal limitation, they do agree that this

phrase should be construed in such a fashion as to make clear that the “graft” contains some

structure that permits it to be attached to a flow lumen. Although the claim language is silent,

the parties also agree that wires perform this function. (See, e.g., Plaintiffs’ Br. at 18:6-7 (“The

parties seem to be in agreement that the structure that allows the anchoring to occur is the

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wires.”) The parties again dispute, however, whether the wires must be malleable. The parties

also dispute whether the wires must project beyond the end of the graft body. 

For the reasons set forth above in Section B.2, the Court concludes that the wires must

be malleable. Although the Court concludes that to serve their function, the wires in question

must be located at or near the end of the graft or graft structure, the wire need not project

beyond the end of the material forming the graft body. In the specification, the inventors state

that the “projection of alternate crests or apices of the end wire or wires beyond at least part of

the end or ends of the graft body is an important feature of this invention.” (‘458 Patent, col. 2,

ll. 6-8.) The inventors then elaborate on the importance of this feature as follows: 

As the graft is expanded by a balloon, the expansion of the wires, and of

the balloon, will be limited by the diameter of the tubular graft body

except in the region of the alternate crests or apices of the end wire or

wires. The balloon will be able to expand these crests slightly more than

the remainder of the wire so that they bell outwardly away from the

adjacent end of the graft body. ... This belling out of the crests of the wires

at one or both ends of the graft body into contact with the inside surface of

the vessel wall and then being at least partly embedded in the wall will

assist in resisting any tendency for the graft to move longitudinally within

the vessel after insertion.

(Id., col. 2, ll. 8-22.) Thus, the importance of the crests of wire is to permit the device to be

expanded in such a fashion that it will engage with the vessel wall. With respect to how far

the crests of wire might extend, the inventors state the crests of wire normally will extend

beyond the end of the graft body. However, they also state that “[i]t would, ... , be possible to

have flaps of graft material protruding up the outside of each crest even though intermediate

the crests the end of the graft stops well short of the crests. In this latter arrangement the

crests are still free to bell outwardly as has been described above even though the crests do

not extend absolutely beyond the end of the graft.” (Id., col. 2, ll. 29-35 (emphasis added).) It

is clear from the specification that if the graft body covers the wire crests, that will not

diminish the importance of the wire crests and will not preclude the wire crests from

performing their function. As such, the Court concludes that the wires need not always

extend beyond the end of the material forming the graft body.

Accordingly, the Court construes the term “graft [structure] which is adapted to be

anchored within one of the flow lumens” to mean: “An intraluminal graft that includes

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9 This term is found in independent claims 15, 17 and 23 of the ‘158 Patent.

10 This term is found in independent claim 1 of the ‘073 Patent.

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malleable wires located proximal to at least one end of the graft [structure], which

enable the intraluminal graft to be secured or attached to one of the flow lumens of the

bifurcated base [graft] structure in an overlapping relationship.”

6. “Graft Structure Which is Adapted to Overlap and Be Attached to One of

the Flow Lumens”9

The parties’ proposed constructions for this phrase are substantially similar to their

proposed constructions for the previous phrase. The only differences are that Plaintiffs and

Cook include a reference to the flow lumens in their proposed constructions, and Gore

references a “second graft” in its proposed construction. Indeed, the parties seem to equate

the phrases “adapted to be anchored within” and “adapted to overlap and be attached to,” with

one another. Once again the disputes center on whether the wires must be malleable and

whether they must project beyond the ends of the graft. 

The Court finds no significant difference between this phrase and the previous phrase

and, accordingly, concludes they should be construed in the same manner. Accordingly, the

Court construes the term “graft which is adapted to overlap and be attached to one of the flow

lumens,” to mean: “An intraluminal graft that includes malleable wires located proximal

to at least one end of the graft structure, which enable the intraluminal graft to be

secured or attached to one of the flow lumens of the bifurcated base graft structure in an

overlapping relationship.”

7. “Said First End of Said Supplemental Graft Body Being Dockable to Said

Second Portion of Said Primary Graft Body While Inside of a Vessel”10

The parties’ primary disputes over this phrase again are whether the phrase should be

construed to require malleable wires and whether those wires must project beyond the end of

the graft. Cook also argues that Plaintiffs’ proposed construction, which includes a reference

to a “fluid containing lumen,” is contrary to the definition of vessel provided in the

specification. 

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To place this phrase in context, claim 1 of the ‘073 Patent recites, in pertinent part: 

a supplemental graft body, said supplemental graft body having a

secondary graft flow lumen therethrough, said supplemental graft body

comprising a first end and a second end, said first end of said

supplemental graft body being dockable to said second portion of said

primary graft body while inside of a vessel to define a single flow lumen

which transfers substantially all flow between said primary graft flow

lumen and said secondary graft flow lumen.

(‘073 Patent, col. 6, ll. 49-57.)

Thus, the claim language suggests that the “first end” of the “graft body” must have

some additional structure that permits the first end to be coupled with or docked to the second

portion of the primary graft body. Although Plaintiffs’ proposed construction does not

expressly refer to such a feature, they argued that the “adapted to be connected,” and “being

dockable” to language was intended to refer to the intraluminal aspect of the invention. (See,

e.g., Tr. at 40:15-41:4, 67:6-18.) Further, all parties concur that intraluminal grafts require

some type of wires. Accordingly, the Court concludes that with respect to this phrase, the

“first end” of the supplemental graft body must include some form of wire structure. For the

reasons discussed above in Sections B.2 and B.5, the Court also concludes that the wires

must be malleable but that they need not extend entirely beyond the end of the graft body. 

Finally, the Court agrees with Cook and Gore that the construction of this term must

include a reference to a vessel, rather than a general reference to a “fluid containing lumen,”

as Plaintiffs’ propose. This is because the inventors clearly defined the term “vessel” in the

specification to mean “blood vessels or like ducts such as the bile duct and the ureter (which

are all hereafter called ‘vessels’).” (‘458 Patent, col. 1, ll. 18-20 (emphasis added).) 

Accordingly, the Court construes the term “said first end of said supplemental graft

body being dockable to said second portion of said primary graft body while inside of a

vessel,” to mean: “The first end of the supplemental graft body includes a malleable wire

structure that permits it to be intravascularly docked to or coupled with the second

portion of the primary graft body.”

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11 This term is found in independent claim 1 of the ‘736 Patent. The parties ask

the Court to construe this term and the term “said inlet end of said second graft body being

attachable in an overlapping relationship with said outlet end of said first graft body while

inside a vessel,” found in independent claims 20, 21 and 22 of the ‘736 Patent in the same

manner.

12 This term is found in independent claim 1 of the ‘073 Patent. The parties ask

the Court to construe this term and the following terms in the same manner: (1) “to define a

continuous flow passage through said first graft body inlet end, said first graft body outlet

end, said second graft body inlet end, and said second graft body outlet end,” found in

independent claim 1 of the ‘736 Patent; (2) “to define a continuous flow passage between

said inlet end and said outlet end of said first graft body and said inlet end and said outlet end

of said second graft body,” found in claims 20 and 22 of the ‘736 Patent; and (3) “to define a

continuous flow passage through said first flow passage and said second flow passage,”

found in claim 21 of the ‘736 Patent.

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8. “Said Second Graft Body Inlet End Being Attachable in an Overlapping

Relationship with Said First Graft Body Outlet End While Inside of a

Vessel”11

The Court finds the crux of the dispute is over the meaning of “being attachable in an

overlapping relationship.” Further, this phrase is substantially similar to the previous phrase,

with the exception of the term “overlapping” and the use of the terms “inlet end” and “outlet

end,” rather than “first end” and “second end” or “first portion” and “second portion.” 

Accordingly, for the reasons set forth in Section B.7, the Court construes the term “said

second graft body inlet end being attachable in an overlapping relationship with said first graft

body outlet end while inside of a vessel,” to mean: “The inlet end of the second graft body

includes a malleable wire structure that permits it to be intravascularly docked to or

coupled with the outlet end of the first graft body in an overlapping relationship.”

9. “To Define a Single Flow Lumen Which Transfers Substantially All Flow

Between Said Primary Graft Flow Lumen”12

Cook argues that this phrase must be construed to require only one flow lumen, i.e.

that the phrase cannot encompass a bifurcated or “y-shaped” graft. It appears that Gore also

suggests that the disputed phrase cannot encompass a bifurcated device, because its proposed

construction focuses on the creation of a single flow lumen. (See Gore Br. at 17.) 

The Court starts with the claim language. With respect to the ‘073 Patent, the claim

language could be read to encompass a bifurcated device, if one assumes that branches or legs

of a bifurcated device are the “second portion” of the primary graft body. This argument,

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however, is less convincing with respect to the claims of the ‘736 Patent, because those claims

refer to a first graft body having an “inlet end” and an “outlet end,” rather than outlet ends.

Because the claim language is ambiguous, the Court looks to the specification. The

specification discloses “trouser” or “bifurcated” grafts, which can be used when the device is

to be placed in or near a bifurcated vessel. Thus, the specification provides support for

Plaintiffs’ assertion that the term “single flow lumen” need not be restricted to a lumen within

a tubular graft. 

Defendants find support for their argument in the prosecution history of the ‘073

Patent, and the inventors’ efforts to distinguish over U.S. Patent 5,316,023 (Palmaz). 

Defendants cite to an Examiner Interview, which the inventors summarized and noted that the

Examiner determined that “the claims could be amended to clearly distinguish over Palmaz

based upon the fact that this application discloses forming a single lumen to carry

substantially all blood flow in a vessel, whereas, what Palmaz ‘023 discloses is two adjacent

lumens inside a stent or a stent graft, inside a vessel, and that the two adjacent lumens in the

vessel split the flow of blood in the vessel between them.” (See Edwards Ex. 28, ‘073

Response dated 11/28/01 at 53-54 (emphasis added).) The Court finds that this reference

supports Plaintiffs’ argument. The inventors’ statement focuses on the fact that their device

forms a single lumen in a vessel. They contrasted their invention to the invention taught by

Palmaz, which formed two lumens inside a vessel. (See also id. at 52 (“Palmaz does not

disclose connecting flow lumens of two graft bodies to define a single flow lumen which

transfers substantially all flow between the engaged lumens.”).) There is nothing in these

statements that suggests the inventors intended to limit their invention to a device that could

be used only in non-bifurcated vessels.

Accordingly, the Court construes the term “to define a single flow lumen which

transfers substantially all flow between said primary graft flow lumen and said secondary

graft flow lumen” to mean: “When the primary graft body is connected to the secondary

graft body a single, rather than a bilateral, lumen is formed and substantially all fluid

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13 This term is found in dependent claims 2 and 11 of the ‘458 Patent and is

found in dependent claims 2 and 8 of the ‘073 Patent. The parties ask the Court to construe

this term and the term “circumferentially reinforced by a metal wire structure,” found in

independent claim 22 of the ‘736 Patent, in the same manner.

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flows from the primary graft body to the secondary graft body through that single flow

lumen.”

10. “Circumferentially Reinforced at Locations Along Its Length by a

Plurality of Separately Spaced Apart Wires”13

There is no dispute among the parties that this phrase should be construed to require

more than one wire and that the wires are placed around the graft in a circular manner. It also

is apparent that the parties agree that the wires are intended to strengthen or support the graft

body, as the Court has defined that term. The parties again dispute whether the wires

referenced in this phrase must be malleable. For the reasons set forth above in Section B.2,

the Court concludes that the wires are malleable. 

The parties also disagree about the meaning of “along its length” and “separately

spaced apart.” With respect to “along its length,” Cook argues that it means “from end to

end,” i.e. that the wires extend the entire length of the device. Cook, however, finds support

for its position from a reference in the specification where the inventors state that because

“the wires are arrayed along the length of the graft the complete position of the graft in the

body can be continuously monitored” by X-ray. (‘458 Patent, col. 3, ll. 42-45.) Plaintiffs and

Gore, in contrast, propose constructions that do not ascribe any special meaning to this term. 

The claim language states that the wires are placed at “locations along its length.” 

(‘458 Patent, col. 6, ll. 22-22.) The use of the word “locations” does not suggest that the wire

must run the entire length of the device. In addition, the specification supports a conclusion

that the wires do not need to run the entire length of the device. For example, in the Abstract,

the inventors state that the invention may include a “plurality of wires spaced apart from each

other and arranged to circumferentially reinforce said tubular graft body along a substantial

portion of its length.” (‘458 Patent, Abstract (emphasis added).) The use of the term

“substantial portion,” rather than “along the entirety” or “along its entire length,” supports

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Plaintiffs’ position that the phrase should not be construed to mean the wires extend from

“end to end.” Further support for the Court’s conclusion stems from the fact that, in certain

preferred embodiments, the invention includes a skirt portion that has no reinforcing wires. 

Thus, in these embodiments, the wires would not extend the entire length of the invention. 

See, e.g., Primos, Inc. v. Hunters Specialties, Inc., 451 F.3d 841, 848 (Fed. Cir. 2006) (court

normally should not interpret a claim to exclude a preferred embodiment). 

Finally, Cook also argues that the inventors, in a later patent application, distinguished

over prior art that disclosed wires that were located only at the end of the graft. (Cook Br. at

19-20; Cook Ex. 15.) To the extent that statement is relevant to construction of the patents-insuit, there is nothing in the inventors’ response that suggests the wires must be placed along

the entirety of the device. Rather, a plausible interpretation of the inventors’ remarks is that

they distinguished the prior art by stating that the prior art had wires only at each end of the

device, whereas the device they were claiming had reinforcing wires at additional locations

and not only at the ends. (See Cook Ex. 15 at 14.)

Gore argues “separate spaced apart” means that the wires cannot touch or overlap. 

Plaintiffs argue that in most instances the wires will not touch one another. Plaintiffs’

proposed construction draws upon the language quoted above from the Abstract, which refers

to where the wires are placed along the graft body. The claim language uses the word “apart,”

which suggests that the wires are separated from one another, i.e. they are not touching. The

figures of the patents-in-suit also show that the wires do not touch or overlap with one

another. (‘458 Patent, figs. 2-3, 5-7.) Further, in the “Disclosure of the Invention” the

inventors state:

It is preferred that the one wire has a greater amplitude than at least the

next adjacent one or two wires. This allows the wires at the end of the

graft to be positioned more closely together than would be the case if they

were all of the same amplitude. ... It is desirable to space the wires

adjacent the end of the graft that will be placed “upstream” in the patient

as close together as is possible as the neck of the aneurysm with which the

graft is engaged can be quite short. Close spacing of the wires maximises

the number of wires reinforcing that part of the graft in contact with the

neck of the aneurysm. The spacing of the rest of the wires is desirably

greater than those adjacent the one end of the graft as this avoids

unnecessarily reducing the flexibility of the graft.

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28 14 This term is found in independent claim 1 of the ‘158 Patent and is found in

dependent claim 13 of the ‘736 Patent.

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(‘458 Patent, col. 2, ll. 36-48; see also id., col. 5, ll. 47-57 (describing spacing of wires in

manner in which wires do not come into contact with one another).) Although this portion of

the specification teaches that the wires may be spaced closely together, it does not teach that

the wires can come into contact with one another. Further, the description of the purpose of

spacing the wire also supports Gore’s construction that the wires should not come into contact

with one another.

Accordingly, the Court construes the phrase “circumferentially reinforced at locations

along its length by a plurality of separately spaced apart wires” to mean: “The graft body or

bifurcated base structure is strengthened by at least two malleable wires that do not

contact or touch one another and that are placed circumferentially along the length of

the material forming the graft body or bifurcated base structure.”

11. “Edge Which is Scalloped Between Projecting Apices of the Wire”14

The parties agree that the term “scalloped” means that there are portions of material

that have been cut out of the fabric or plastic. The primary dispute between Plaintiffs and

Cook is whether the phrase must be limited such that the “scalloping” occurs only “between,”

i.e. in the space that separates, each wire apice, as depicted in figures 6-7 of the patents-insuit, or whether the fabric may also contain scalloping underneath the wire apices. 

The specification states that “[i]t is preferred” that the edge of the material is

“scooped out or scalloped between each projecting crest.” (‘458 Patent, col. 2, ll. 56-58

(emphasis added).) If the Court looked only to the claim language, Cook’s argument might

have some force. However, because the specification makes clear that the scallops “between”

the projecting crests are preferred but not required, the Court declines to construe this phrase

to limit it to a preferred embodiment. See, e.g., Primos, Inc., 451 F.3d at 848 (court should

not import limitations from preferred embodiments into claims). 

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Plaintiffs and Gore also disagree about whether the wires always extend beyond the

edge of the material. For the reasons set forth above in Section B.5, the Court concludes that

they do not.

Accordingly, the Court construes the term “edge which is scalloped between

projecting apices of the wire member/structure” to mean: “The edge of the material may be

scooped out or removed between or underneath each projecting crest of the wire.”

CONCLUSION

Based on the analysis set forth above, the Court adopts the foregoing constructions of

the disputed terms and phrases. The parties are ordered to submit a further joint case

management report pursuant to Patent Standing Order ¶ 13 by no later than August 20, 2007. 

IT IS SO ORDERED.

Dated: July 23, 2007 

JEFFREY S. WHITE

UNITED STATES DISTRICT JUDGE

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APPENDIX

1. Prosthesis

Plaintiff’s Proposed Construction:

“An artificial device to repair or replace a missing or defective part of the body.”

Cook’s Proposed Construction:

“An intraluminal device that substitutes for a missing or defective part of the body.”

Gore’s Proposed Construction:

“A multi-component device used as a unit to treat medical conditions such as

aneurysms or occlusive diseases endoluminally, that is, from the inside of a body vessel.”

***

2. Graft

Plaintiffs’ Proposed Construction:

“An artificial (or man-made) device, formed of polymer (plastic) or fabric material,

that is attached to or inserted into another vessel or graft.”

Cook’s Proposed Construction:

“An intraluminal device that substitutes for all or part of a vessel.”

Gore’s Proposed Construction:

“A multi-component device used as a unit to treat medical conditions such as

aneurysms or occlusive diseases endoluminally, that is from inside of a body vessel.”

***

3. Bifurcated Base [Graft] Structure

Plaintiffs’ Proposed Construction:

“A Y-shaped graft that forms a structure (or foundation) for connection of

additional grafts.”

Cook’s Proposed Construction:

“A trouser-shaped intraluminal graft composed of a material integrated with at least

one malleable wire that does not expand by virtue of its own resilience.”

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Gore’s Proposed Construction:

“A forked or divided fabric liner for the inside of a body vessel with one tubular

opening at one end and two tubular openings at the other end, attached to a malleable wire

structure.”

***

4. A Pair of Connector Legs

Plaintiffs’ Proposed Construction:

“The two branches of the Y-shaped base.”

Cook’s Proposed Construction:

“Two legs of the same size.”

Gore’s Proposed Construction:

“Two substantially identical branches shaped like trousers on the bifurcated base

structure, each of which has an opening for connecting to a graft adapted to be anchored

within the graft.”

***

5. Graft Body

Plaintiffs’ Proposed Construction:

“An artificial (or man-made) device, formed of polymer (plastic) or fabric material,

that is attached to or inserted into another vessel or graft body.” 

Cook’s Proposed Construction:

“An intraluminal graft composed of a material integrated with at least one malleable

wire that does not expand by virtue of its own resilience.”

Gore’s Proposed Construction:

“A tubular fabric liner for the inside of a body vessel attached to a malleable wire

structure with an inlet end and an outlet end forming a single flow cavity or channel.”

***

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6. Graft [structure] which is adapted to be anchored within one of the flow lumens

Plaintiffs’ Proposed Construction:

“A graft having additional structure that allows the graft to be mechanically

attached (not sewn) to the base structure by insertion and expansion into the base structure

in an overlapping position. The graft structure sufficiently secures the graft to the base so

that it is not transported away from the base structure (i.e., remains secured to the base

structure) under conditions of fluid (blood) flow.”

Cook’s Proposed Construction:

“An intraluminal graft composed of a material integrated with at least one malleable

wire that does not expand by virtue of its own resilience and that projects beyond the end

of the wire so that the wire can be expanded into contact with the bifurcated base [graft]

structure.”

Gore’s Proposed Construction:

“The malleable wire structure of the tubular endoluminal graft gives it the ability to

attach to or connect to the inside of the connector legs or the inside of the common flow

lumen of the bifurcated base structure inside a body vessel.”

***

7. Graft [structure] which is adapted to be overlap and be attached to one of the flow

lumens

Plaintiffs’ Proposed Construction:

“A graft having additional structure that allows the graft to be mechanically

attached (not sewn) to one of the flow lumens of the base structure by insertion and

expansion into the base structure in an overlapping position. The graft structure

sufficiently secures the graft to the base so that it is not transported away from the base

structure (i.e., remains secured to the base structure) under conditions of fluid (blood)

flow.”

Cook’s Proposed Construction:

“An intraluminal graft composed of a material integrated with at least one malleable

wire that does not expand by virtue of its own resilience and that projects beyond the end

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of the wire so that the wire can be expanded into attachment to one of the flow lumens of

the bifurcated base [graft] structure.”

Gore’s Proposed Construction:

“The malleable wire structure of the tubular endoluminal second graft structure

gives it the ability to attach to or connect it to the inside of the connector legs or the inside

of the common flow lumen of the bifurcated base structure inside a body vessel.”

***

8. Said first end of said supplemental graft body being dockable to said second

portion of said primary graft body while inside of a vessel

Plaintiffs’ Proposed Construction:

“One end of a second graft portion can be maneuvered to be coupled with one end

of a first graft portion while in a fluid-containing lumen (i.e., endovascularly).”

Cook’s Proposed Construction:

“At least one malleable wire (that does not expand by virtue of its own resilience)

in the supplemental graft body projects beyond the end of the material so that the wire can

be expanded into attachment with the primary graft body while both graft bodies are

entirely inside of a vessel.”

Gore’s Proposed Construction:

“The malleable wire structure of the supplemental graft body gives it the ability to

dock or connect to the inside of the primary graft body while inside of a body vessel.”

***

9. Said second graft body inlet end being attachable in an overlapping relationship

with said first graft body outlet end while inside of a vessel 

Said inlet end of said second graft body being attachable in an overlapping

relationship with said outlet end of said first graft body while inside of a vessel

Plaintiffs’ Proposed Construction:

“The inlet end of a second graft body can be maneuvered to be coupled with the

outlet end of a first graft body while in a fluid containing lumen (i.e., endovasularly).”

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Cook’s Proposed Construction:

“At least one malleable wire in the second graft body projects beyond the end of the

material so that the wire can be expanded into attachment with the first graft body outlet

end while both graft bodies are entirely inside of a vessel.”

Gore’s Proposed Construction:

“The malleable wire structure of the second graft body gives it the ability to attach

itself to the inside of the first graft body when it is extended into and is partially covered by

the first graft body while inside of a body vessel to form a single, continuous flow

passage.”

***

10. To define a single flow lumen which transfers substantially all flow between said

primary graft flow lumen and said secondary graft flow lumen

To define a continuous flow passage through said first graft body inlet end, said

second graft body inlet end, and said second graft body outlet end

To define a continuous flow passage between said inlet end and said outlet end of

said first graft body and said outlet end of said second graft body

To define a continuous flow passage through said first flow passage and said

second flow passage

Plaintiffs’ Proposed Construction:

One end of one structure can be coupled with one end of another structure to form a

single fluid flow cavity for transfer of essentially all of the flowing fluid between the two

structures – substantially all flow means more of the flow within a blood vessel than would

be carried by each of the two parallel tubes of Palmaz.

Cook’s Proposed Construction:

After they are docked, the primary and supplemental graft bodies together have

only one flow lumen therethrough so that substantially all the flow that enters the upstream

end of the primary graft body exists the downstream end of the supplemental graft body.

Gore’s Proposed Construction:

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When joined, the graft bodies form a single cavity or channel which transfers

substantially all fluid between the single cavity or channel in the primary graft body to the

single cavity or channel in the supplemental graft body.

***

11. Circumferentially reinforced at locations along its length by a plurality of

separate spaced apart wires

Circumferentially reinforced by a metal wire structure

Plaintiffs’ Proposed Construction:

The graft material is augmented or strengthened along its length at its

circumferential perimeter (i.e. radially) by at least two wires that are separated (not

contacting or touching along a substantial portion of their lengths).

Cook’s Proposed Construction:

The material is strengthened around its circumference from end to end by at least

two distinct integrated malleable wires that do not expand by virtue of their own resilience.

Gore’s Proposed Construction:

The [bifurcated base graft structure or graft or primary graft body or supplemental

graft body] is reinforced at discrete locations along its length by two or more distinct and

malleable wires which individually encircle the graft, but which are not attached to and do

not overlap one another.

***

12. Edge which is scalloped between projecting apices of the wire [member/structure]

Plaintiffs’ Proposed Construction:

At least part of one edge of the graft material is scooped out or removed between

extending wire forms.

Cook’s Proposed Construction:

The edge of the material is scooped out between (and not underneath) each

projecting crest of the wire so that there are the same number of scoops as there are

projecting crests.

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Gore’s Proposed Construction:

The structure has a wire member near the end with more than one apex or tip that

extends beyond the end of the fabric liner with the edge of the fabric liner cut away

between the wire apices or tips that extend beyond the edge of the fabric liner.

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