COOK INCORPORATED v. ENDOLOGIX, INC.

Filing 145

ENTRY on Claim Construction - The disputed claim terms have the meaning set out in this order. Signed by Judge Tanya Walton Pratt on 8/16/2011.(TRG)

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF INDIANA
INDIANAPOLIS DIVISION
COOK INCORPORATED,
Plaintiff,
v.
ENDOLOGIX, INC.,
Defendant.

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Case No. 1:09-cv-1248-TWP-DKL

ENTRY ON CLAIM CONSTRUCTION
This patent infringement case involves two patents that relate to endovascular
technologies. The Court has been called upon to construe disputed claims, terms, phrases, and
clauses of U.S. Patent No. 5,035,706 (the “‘706 patent”) and U.S. Patent No. 5,755,777 (the
“‘777 patent”) pursuant to Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995)
(en banc), aff’d, 517 U.S. 370 (1996). The Plaintiff in this case is Cook Incorporated (“Cook”),
the owner of the ‘706 and ‘777 patents. The Defendant in this case is Endologix, Inc.
(“Endologix”). On April 15, 2011, the Court held oral arguments on claim construction. The
parties have submitted thorough and well-crafted briefs and supplementary materials to the
Court, and jurisdiction is proper under 28 U.S.C. § 1338.
BACKGROUND
A. Type of devices
This patent dispute involves medical devices that treat abdominal aortic aneurysms
(“AAA”). An AAA is caused by a weakening of the wall of the aorta, the largest human artery.

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This weakening can cause a balloon-like enlargement to develop in the aorta, increasing the
chances of a rupture. Aortic ruptures are often fatal.
To understand how these lifesaving devices generally work, some brief background is
instructive. Until the 1990's, AAA’s were typically treated through surgery that was incredibly
risky and painful. The surgeon had to open the patient’s chest and/or abdomen; move the
patient’s intestines to expose the aorta; cut out the diseased portion of the patient’s aorta; and
sew a new graft conduit into the aorta while diverting blood flow to the patient’s lower body.
Given the invasive and traumatic nature of this procedure, the patient faced a long and uncertain
recovery.
Thankfully, brilliant innovators pushed technology forward. Eventually, surgeons began
using self-expanding stent grafts, or small tubular wire cages (i.e. stents) covered with fabric
grafts (i.e. grafts), to treat AAA’s. These stent-based procedures obviate the need to cut open the
patient’s chest and/or abdomen, move intestines, and interrupt blood flow to the lower body. In
turn, these stent-based procedures are far less risky and invasive, requiring shorter hospital stays
and less recovery time.
Generally, to effectuate these procedures, the surgeon inserts a tube containing an
expandable stent graft into the patient through a small incision, usually in the groin to give
access to the femoral artery. The tube carries the stent, in a compressed state, to the treatment
site. Once there, the stent is released and it self-expands into position. Upon expanding, the
stent serves as a new pathway for blood flow down the aorta, relieving pressure on the AAA and
thus preventing a rupture.

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B.

Parties and products
Numerous companies make stents, including Cook and Endologix. Cook’s flagship stent

is called the Zenith (which is not at issue). Endologix’s is called the PowerLink (which is
allegedly infringing a Cook patent). Cook alleges that Endologix, through the sale of its
PowerLink stent and accompanying delivery system (the “Intuitrak”), is infringing two Cook
patents: (1) the ‘706 patent, which relates to the actual stent; and (2) the ‘777 patent, which
relates to the delivery system that carries the stent to the treatment site. The Court will discuss
these patents in more detail in the discussion section below.
LEGAL STANDARD
In order to win a patent infringement suit, a plaintiff must establish that the patent claim
“covers the alleged infringer’s product or process.” Markman, 517 U.S. at 374 (citation and
internal quotations omitted). Consequently, the first step in an infringement analysis involves
determining the meaning and the scope of the words of the patent’s claims. Johnson Worldwide
Associates, Inc. v. Zebco Corp., 175 F.3d 985, 988 (Fed.Cir.1999). Patent claims are construed
as a matter of law. Markman, 52 F.3d at 979. The Federal Circuit has emphasized that “[i]t 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.” Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir.
2005) (en banc) (citation and internal quotations omitted).
The words of a claim are generally given their “ordinary and customary meaning,” as
understood by a person of skill in the art at the time the patent was filed. Id. at 1312-13. “The
construction that stays true to the claim language and most naturally aligns with the patent’s
description of the invention will be, in the end, the correct construction.” Id. at 1316 (citation and
internal quotations omitted). “[A]bsent contravening evidence from the specification or
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prosecution history, plain and unambiguous claim language controls the construction analysis.”
DSW, Inc. v. Shoe Pavilion, Inc., 537 F.3d 1342, 1347 (Fed. Cir. 2008).
In the process of discerning the meaning of a claim as understood by a person of ordinary
skill in the art, a court may look to various sources. Most notably, courts may turn to intrinsic
evidence, which includes “the words of the claims themselves, the remainder of the specification,
[and] the prosecution history.” Phillips, 415 F.3d at 1314. The Federal Circuit has recognized
that the patent specification is “the single best guide to the meaning of a disputed term.” Id. at
1315 (citation and internal quotations omitted). Courts may also consult the written history of
the patentee’s dealings with the Patent and Trademark Office (“PTO”) (i.e. the prosecution
history) because it provides insight into how the PTO and the inventor understood the invention.
Id. at 1317. Finally, courts may consider evidence external to the patent (i.e. extrinsic evidence)
– such as expert testimony, treatises, or dictionaries – but this evidence is less significant than
intrinsic evidence. Id.
Specific examples (i.e. “preferred embodiments”) in the written description of the patent
can shed light on the intended scope of the claims. Boss Control, Inc. v. Bombardier Inc., 410
F.3d 1372, 1377 (Fed. Cir. 2005) (citations and internal quotations omitted). Nonetheless, “[t]he
patentee is entitled to the full scope of his claims, and we will not limit him to his preferred
embodiment or import a limitation from the specification into the claims.” Kara Technology Inc.
v. Stamps.com Inc., 582 F.3d 1341, 1347-48 (Fed. Cir. 2009). In that same vein, “[t]he law does
not require…that an applicant describe in his specification every conceivable and possible future
embodiment of his invention.” SRI Int’l v. Matsushita Elec. Corp. of America, 775 F.2d 1107,
1121 (Fed. Cir. 1985) (en banc).

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DISCUSSION
The discussion section is divided into two parts. First, the Court will discuss the
background of the ‘706 patent, the relevant claims, and then resolve the disputed terms. Then,
the Court will do the same for the ‘777 patent.
A. The ‘706 patent
Cook has stood at the forefront of endovascular technology for numerous decades.
Significantly, Cook’s ‘706 patent claims an improvement on an earlier Cook patent, U.S. Patent
No. 4,580,568 (“the “‘568 patent”). The ‘568 patent (which expired in 2004 and was not
asserted in this case) covers a specific type of self-expanding stent known as a Z-stent, which is
made from a single wire bent into a “zig-zag” shape. A depiction of a Z-stent is set forth below.

Z-stents can be compressed, inserted into a vessel, and then re-expanded by virtue of the
spring-expanding nature of their wire. This self-expanding stent technology was, in Cook’s
words, “wildly successful.” Z-stents were not a panacea, however. They were often too short,
meaning stenting over long lengths required multiple stents, each delivered through a separate
catheterization. Physicians wanted a stent that could treat longer passageways with only a single
catheterization.

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The ‘706 patent – which embodies an improvement of the ‘568 patent – helped fill this
niche, covering a method of connecting several Z-stents together. The application for the ‘706
patent was filed in 1989 and the ‘706 patent was issued in 1991. Importantly, the ‘706 patent
uses a series of “eyes” on one end of the stent that interlock with a matching set of eyes on
another stent. As Cook states, “the interlocking stent assembly permits and assures a
combination of stents that can be deployed at the same time and over longer vessel lengths, to
provide a simpler, and less invasive medical procedure.” (Dkt. 107 at 13). Figure 5 of the ‘706
patent (reproduced below) depicts an example of such a stent assembly.

In this lawsuit, Cook contends that its competitor Endologix – a relative newcomer to the market
for endovascular technology, at least compared to Cook – is infringing the ‘706 patent through
the sale of its PowerLink stent graft.
1. Claims
In this action, Cook asserts Claims 6 and 12 of the ‘706 patent against Endologix.1 Claim
6 of the ‘706 patent reads as follows:

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On April 20, 2010, the PTO issued a reexamination certificate confirming the patentability of
Claims 6 and 12 of the ‘706 patent.
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Claim 6:

A method for combining a first and second self-expanding stent to form a stent
assembly for insertion into a body passageway comprising the steps of:
forming a first stent from a continuous first length of wire formed into a
closed zig-zag configuration having an endless series of straight sections
joined at their ends by a plurality of bends;
forming a second stent from a continuous second length of wire formed into a
closed zig-zag configuration having an endless series of straight sections
joined at their ends by a plurality of bends, the bends at one end defining
eyes open at the straight sections of the second stent;
engaging the eyes at the one end of the second stent about bends at one end of
the first stent; and closing the eyes at the one end of the second stent.

Claim 12 of the ‘706 patent reads as follows:
Claim 12:
A stent assembly comprising:
a first wire formed into a closed zig-zag configuration including;
an endless series of straight sections having opposite ends, said straight sections
being joined by bends at said opposite ends to form a first stent;
and
a second wire formed into a closed zig-zag configuration including;
a second endless series of straight sections having opposite ends, said straight
sections being joined by bends at said opposite ends to form a second stent;
a set of eyes formed at several of said bends at one of said opposite ends;
wherein said first and second stents are resiliently contractable into smaller first
shape for conveyance through a body passageway;
wherein said first and second stents are resiliently expandable into a second shape in
which the straight sections press against the walls of the body passageway; and
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wherein said set of eyes of said second stent are engaged about said first wire at one
of said opposite ends of said first wire.

2. Disputed Terms
The parties dispute many of the ‘706 patent’s terms for purposes of Markman
construction. Each disputed term is addressed in turn.
Term 1: “for combining . . .”
Claim Term

Endologix’s Construction

Cook’s Construction

for combining a first
and second selfexpanding stent to form
a stent assembly

for attaching two tubular structures
capable of being inserted into and
holding open a human body
passageway and that spring open
when a compressive force is
removed, so as to form a pair of
connected stents

for combining a first stent that
spring expands when a
compressive force is removed
and a second stent that spring
expands when a compressive
force is removed to form a
stent assembly

This term is found in the preamble of Claim 6. Normally, terms recited in the preamble
of a claim are merely “a convenient label for the invention as a whole,” and, therefore, do not
limit the scope of the claim. Storage Technology Corp. v. Cisco Systems, Inc., 329 F.3d 823, 831
(Fed. Cir. 2003). Where, however, a preamble term is necessary to breathe “life, meaning, and
vitality” into the claim, the preamble will be limiting. NTP, Inc. v. Research in Motion, Ltd., 418
F.3d 1282, 1305 (Fed. Cir. 2005). Both parties ask the Court to construe this term; therefore, the
Court will heed their request.
Cook’s proposed construction is limited, primarily asking the Court to construe “selfexpanding” to mean that the stent “spring expands when a compressive force is removed.”

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Endologix, on the other hand, proposes a more in-depth construction that would construe
“combining,” “stent,” “self-expanding,” and “stent assembly.”
As an initial matter, the Court believes that the terms “combining,” “stent,” and “stent
assembly” require no construction, since their ordinary meaning is readily understandable. The
Federal Circuit has encouraged courts to give a claim term its ordinary meaning when
appropriate. Phillips, 415 F.3d at 1314 (“In some cases, the ordinary meaning of claim language
as understood by a person of skill in the art may be readily apparent even to lay judges, and
claim construction in such cases involves little more than the application of the widely accepted
meaning of commonly understood words.”). Moreover, the Court agrees with Cook that
“expands” is a more fitting term than “open.” In the Court’s view, “open” is something of a
binary concept: either something is open or it’s closed. Expands, by contrast, implies more of a
process. In other words, a stent could be in the process of expanding, even if it’s not yet fully
open.
Finally, Endologix’s use of the word “pair” is somewhat misguided, given that “pair”
denotes “two,” while Figure 6 of the ‘706 patent shows three interlocking stents. (Dkt. 107-5 at
3). Moreover, the ‘706 patent specification makes clear that “[a] number of self-expanding
stents can be combined by joining the stents at the eyes.” (Dkt. 107-5 at 6; col. 2, ll. 32-34;
emphasis added). This language reinforces that Endologix’s use of “pair” is improper. For these
reasons, the Court adopts Cook’s proposed construction.

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Term 2: “closed zig-zag . . .”
Claim Term

Endologix’s Construction

Cook’s Construction

wire formed into a
closed zig-zag
configuration

zig-zag structure with the two
ends of the wire joined together

A series of zig-zags
traveling in a generally
circular path and defining a
cylindrical configuration

Claims 6 and 12 state that the wire is “formed into a closed zig-zag configuration.” The
term “closed” is at the heart of the parties’ dispute. Endologix argues that “closed” refers to the
fact that the two ends of the wire are joined together. Cook, by contrast, argues that “closed”
refers to the overall three dimensional configuration of the formed stent.
To bolster its position, Cook notes that the ‘568 patent is incorporated by reference in
the specification of the ‘706 patent. Indeed, “[w]hen a document is incorporated by reference
into a host document, such as a patent, the referenced document becomes effectively part of the
host document as if it were explicitly contained therein.” Vishay Dale Electronics, Inc. v. Cyntec
Co., Ltd., 627 F. Supp. 2d 1050, 1058 (D. Neb. 2008) (citation and internal quotations omitted).
Cook then highlights that the ‘568 patent’s specification in the preferred embodiment section
states that “the stent has generally a circular configuration or a cylindrical configuration when it
is in its second expanded shape.” (Dkt. 107-6 at 6; col. 3, ll. 2-4; emphasis added).

But, in the

Court’s view, “circular” or “cylindrical” would constitute a marked deviation from the plain and
ordinary meaning of “closed.” This raises the question: If the drafter meant for “closed” to mean
“cylindrical” or “circular,” why not just say it? See Sage Products, Inc. v. Devon Industries, 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
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bear the cost of its failure to seek protection for this foreseeable alteration of its claimed
structure.”).
Moreover, the ‘706 patent specification in the preferred embodiment section indicates
that “closed” refers to the two ends of the wire being joined together, stating that “the
percutaneous stent 10 which is formed in a closed zig-zag configuration. The ends of the wire
are closed by a sleeve 12 which is welded or tightly squeezed against the ends of the wire to
produce a continuous or endless configuration.” (Dkt. 107-5 at 7; col. 3, ll. 60-65; emphasis
added). The ‘568 patent specification largely echoes this statement, providing “[t]he wire is
closed by a sleeve 11 which is welded or tightly squeezed against the ends of the wire to produce
the endless configuration.” (Dkt. 107-6 at 5; col. 2, ll. 52-55; emphasis added) Cook counters
that Endologix’s construction reads a limitation from a preferred embodiment into the Claims.
However, the Court is not persuaded. The Claim requires a “wire formed into a closed . . .
configuration,” and Cook does not identify any way to “close” a wire other than by joining the
ends together. The Court is persuaded that “closed” refers to the fact the ends of the wire are
joined together. Accordingly, the Court adopts Endologix’s proposed construction, as it aligns
with the plain meaning of the claim language and the intrinsic evidence.
Term 3: “endless series . . .”
Claim Term

Endologix’s Construction

Cook’s Construction

having an endless
series of straight
sections joined at their
ends by a plurality of
bends

having a repeating pattern of
straight sections connected by
bends and forming a single ring

the series of straight portions
of the generally cylindrical
configuration, where
adjacent ends of the straight
section are joined by a bend.

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Claim 6 describes “having an endless series of straight sections joined at their ends by a
plurality of bends.” Cook emphasizes that “having an endless series of straight sections”
characterizes the overall “configuration,” making for a mechanically efficient way of
compressing the stent for purposes of self-expansion. Endologix emphasizes that “endless”
means just that – a never-ending or repeating pattern that is caused by the act of “closing” (i.e.
joining the two ends of the wire together). Endologix further emphasizes that this concept is
supported by the specification of the ‘706 patent, which states: “The ends of the wire are closed
by a sleeve 12 which is welded or tightly squeezed against the ends of the wire to produce a
continuous or endless configuration. The length 11 of wire is arranged in a number of side-byside straight sections.” (Dkt. 107-5 at 7; col. 3, ll. 62-67; emphasis added). The Court believes
that, generally, Endologix has the stronger argument.
On this point, Cook does not really address the meaning of “endless” in its construction.
Along similar lines, the Court believes that Cook’s proposed construction for “closed” and
“endless” are essentially identical, meaning that if the Court adopted both of Cook’s
constructions, one of these terms would be rendered superfluous. See Merck & Co. v. Teva
Pharms, USA, Inc., 395 F.3d 1364, 1372 (Fed. Cir. 2005) (“A claim construction that gives
meaning to all the terms of the claim is preferred over one that does not do so.”).
That said, the Court is concerned by the portion of Endologix’s proposed construction
involving the formation of “a single ring,” which could imply a two dimensional object. A stent,
by contrast, is three dimensional. In the Court’s view, a more accurate description of the
resulting structure of the stent – which is what the word “endless” is getting at – is a
“configuration that is generally cylindrical upon expanding.” Accordingly, the Court modifies
Endologix’s proposed construction and construes “an endless series of straight sections joined at
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their ends by a plurality of bends” as “having a repeating pattern of straight sections connected
by bends and forming a configuration that is generally cylindrical upon expanding.”
Term 4: “forming . . . from a continuous . . . length of wire”
Claim Term

Endologix’s Construction

Cook’s Construction

forming a [first/second]
stent from a continuous
[first/second] length of
wire

forming a [first/second] stent from a
single [first/second] length of wire

forming a [first/second] selfexpanding stent from a single
[first/second] length of wire

This term is found in Claim 6. Endologix only quarrels with Cook’s inclusion of the
phrase “self-expanding.” Given that the stent at issue is unquestionably self-expanding, the
Court sees no problem with the inclusion of this phrase. Accordingly, the Court agrees with
Cook’s proposed construction.
Term 5: bends at one end defining eyes open
Claim Term

Endologix’s Construction

Cook’s Construction

bends at one end
defining eyes open

bends at one end defining sections of
wire largely enclosing a space and
linked to the ends of the straight
sections by cusps or sharp bends

bends at one end defining
partial loops

This term is found in Claim 6. The parties dispute the meaning of the term “eyes open.”
Significantly, the specification in the preferred embodiment section of the ‘706 patent states:

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In one novel aspect of the present invention, the cusps 14 of the stent are
formed into a number of eyes 20. In the preferred embodiment, the eyes
are formed in the continuous wire 11 and the intersection between
adjacent straight sections 13 at the cusps 14 are soldered or welded
together to provide a closed loop for the eyes 20.
(Dkt. 107-7 at 7; col. 4, ll. 15-21; emphasis added). Endologix argues that the inclusion of the
phrase “the present invention” clarifies that the use of “cusps” is not just one embodiment of the
invention, but instead a “fundamental feature” of the invention. (Dkt. 118 at 18). Indeed, “when
the preferred embodiment is described in the specification as the invention itself, the claims are
not necessarily entitled to a scope broader than that embodiment.” Chimie v. PPG Industries,
Inc., 402 F.3d 1371, 1379 (Fed. Cir. 2005) (citation and internal quotations omitted).
Cook, of course, disagrees, contending that this language is merely directed to a preferred
embodiment. See Kara Tech, 582 F.3d at 1348 (“The claims, not the specification embodiments,
define the scope of patent protection.”). In other words, although a preferred embodiment may
use cusps, they are not required to make the invention. To bolster this argument, Cook relies
heavily on the reexamination proceedings.
In the end, the Court is persuaded by Endologix’s argument, as the language “the present
invention” used in the first sentence of the above excerpted paragraph is “strong evidence” as to
how the claim language should be read. See SciMed Life Systems, Inc. v. Advanced
Cardiovascular Systems, Inc., 242 F.3d 1337, 1343 (Fed. Cir. 2001) (construing term to include
feature of “the present invention”).2 Additionally, the second sentence of the above excerpted

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At oral arguments (Dkt. 139 at 74), Cook highlighted Flexhead Industries, Inc. v. Easyflex, Inc.,
2008 WL 4813797 (D. Mass. Nov. 3, 2008) for the proposition that the phrase “one aspect of the
invention” does not refer to the invention as a whole, but merely an embodiment. Id. at *6.
However, under these circumstances, the Court is not persuaded. In the Court’s view, “aspect” is
synonymous with “a feature,” not an “embodiment.”
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paragraph reinforces this position, as it begins with the phrase, “In the preferred embodiment. .
.”. This language would be altogether superfluous if the first sentence was already limited to a
preferred embodiment. Moreover, the Court’s decision is fortified by the fact that Cook never
identifies a disclosure or description in the ‘706 specification that does not include cusps.
Further, the results of the reexamination proceedings do not compel a contrary ruling. In
the reexamination, the examiner found that “the loop or hook . . . of Wiktor are not closed like
the eyes in the ‘706 patent and therefore, Wiktor does not teach the step of closing the eyes in
claim 6.” (Dkt. 121-5 at 4). However, the examiner did not equate a “partial loop” with an “open
eye,” as Cook suggests.
That said, the Court is reticent to adopt Endologix’s entire proposed construction.
Specifically, Endologix’s use of the word “space” in the phrase “largely enclosing a space” is
vague. The Court believes that in lieu of “space,” “loop” better aligns with the claim language.
This position is reinforced by the ‘706 patent specification: “In the preferred embodiment, the
eyes are formed in the continuous wire 11 and the intersection between adjacent straight sections
13 at the cusps 14 are soldered or welded together to provide a closed loop for the eyes 20.”
(Dkt. 107-5 at 7; col. 4, ll. 17-21; emphasis added). For these reasons, the Court construes
“bends at one end defining eyes open” as “bends at one end defining sections of wire largely
enclosing a loop and linked to the ends of the straight sections by cusps or sharp bends.”

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Term 6: Engaging the eyes
Claim Term

Endologix’s Construction

Cook’s Construction

engaging the eyes at the
one end of the second
stent about bends at
one end of the first
stent

then interlocking each open eye at the interlocking the eyes at the
one end of the second stent with a
one end of the second stent
bend at one end of the first stent
with bends at one end of the
first stent

The parties generally agree that “engaging” in this Claim 6 term means “interlocking.”
So, fortunately, their dispute is limited to the use of the word “then.” Stated differently, does
Claim 6 dictate a sequence to the claimed steps? Relying on Altiris, Inc. v. Symantec Corp., 318
F.3d 1363 (Fed. Cir. 2003), Endologix argues that it does. See id. at 1369 (steps can be implicitly
construed to require an order “as a matter of logic or grammar”). Relying on that same case,
Cook argues that it does not. See id. at 1371 (refusing to limit claims to sequence even though
preferred embodiment showed a sequence of steps; “[n]owhere, however, is there any statement
that this order is important, any disclaimer of any other order of steps, or any other prosecution
history indicating a surrender of any other order of steps.”).
The Court sides with Cook. The crux of Endologix’s argument is that the engaging step
can only occur after completely forming the stents. However, this position appears to be
contradicted by the specification, which contemplates the possibility that engaging can occur
prior to the second stent’s completion: “the eyes 20” formed at one end of the stent are
interlocked with the eyes 20’ of the first stent 10’. Once the second stent 10” is complete. . .”.
(Dkt. 107-5 at 7; col. 4, ll. 40-43; emphasis added). Moreover, it is worth noting that the
preamble of Claim 6 uses the phrase “comprising the steps of,” which weighs against requiring a
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precise sequential order. See Ductmate Industries, Inc. v. Famous Supply Corp., 55 F. Supp. 2d
777, 784 (N.D. Ohio 1999) (“The Court construes the language comprising the steps of . . . to not
require a person assembling the ducts to follow the identified steps in exact sequential order.”).
In the Court’s view, engaging can still occur while the second stent is still forming;
consequently, the Court adopts Cook’s proposed construction.
Term 7: closing the eyes
Claim Term

Endologix’s Construction

Cook’s Construction

closing the eyes at the
one end of the second
stent

then altering the shape of each open
eye to completely enclose a space

forming loops at the end of
the second stent

This term, found in Claim 6, is disputed on two grounds. First, Endologix’s proposed
construction uses the word “then.” For reasons similar to those explained directly above,
however, the Court is not persuaded that this inclusion is appropriate.
Second, the parties revisit a variation of the “loop” versus “enclosed space” debate that
was discussed in the construction of the term “eyes open.” Specifically, Cook likens “closing the
eyes” to “forming loops.” To bolster this proposed construction, Cook points to the ‘706 patent
specification in the preferred embodiment section: “the eyes are formed in the continuous wire
11 and the intersection between adjacent straight sections 13 at the cusps 14 are soldered or
welded together to provide a closed loop for the eyes 20.” (Dkt. 107-5 at 7; col. 4, ll. 17-21;
emphasis added). However, the Court is not persuaded and agrees with Endologix that “[a]t this
stage of the claimed method, the eye is being changed from open to closed, not being “formed”
in the first place.” (Dkt. 118 at 21). For this reason, the Court finds that Endologix’s proposed
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construction is more appropriate – with two caveats. First, the Court finds that Endologix’s use
of “then” is improper. Second, for the reasons set forth above, in the “defining eyes open” term,
“space” should be replaced with “loop.” For these reasons, the Court construes “closing the eyes
at the one end of the second stent” as “altering the shape of each open eye to completely enclose
a loop.”
Term 8: “endless series of . . .”
Claim Term

Endologix’s Construction

Cook’s Construction

endless series of
straight sections having
opposite ends, said
straight sections being
joined by bends at said
opposite ends

repeating pattern of straight sections
connected by bends and forming a
single ring wherein all of the bends
are located at one or other ends of the
ring

the series of straight portions
of the generally cylindrical
configuration, where adjacent
ends of the straight sections
are joined by a bend

This term is found in Claim 12 of the ‘706 patent. The Court has already construed a
similar term in Claim 6 involving the phrase “endless series of straight sections.” In doing so,
the Court adopted a modified version of Endologix’s construction, expressing its discomfort with
the phrase “forming a single ring” because it could imply a two dimensional object. In doing so,
the Court replaced “forming a single ring” with “forming a configuration that is generally
cylindrical upon expanding.” The Court takes the same approach with the present term. See
Innova/Pure Water, Inc. v. Safari Water Filitration Systems, Inc., 381 F.3d 1111, 1119 (Fed. Cir.
2004) (“Unless otherwise compelled, when different claims of a patent use the same language,
we give that language the same effect in each claim.”).
However, the Court finds the remaining portion of Endologix’s proposed construction
confusing. The language “located at one or other ends” implies one out of two, which strikes the
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Court as misguided. The Court’s understanding is that bends are located at both ends of the
straight section. Accordingly, the Court construes “endless series of straight sections having
opposite ends, said straight sections being joined by bends at said opposite ends” as “repeating
pattern of straight sections connected by bends and forming a configuration that is generally
cylindrical upon expanding, where adjacent ends of the straight sections are joined by a bend.”
Term 9: “set of eyes formed at several of said bends . . .”
Claim Term

Endologix’s Construction

Cook’s Construction

set of eyes formed at
several of said bends at
one of said opposite
ends

sections of wire each enclosing a
space and linked to the ends of the
straight sections by cusps or sharp
bends at more than two of the bends
at one of the opposite ends of the
second stent

a loop is formed at each of at
least two bends

This term is found in Claim 12 of the ‘706 patent. It essentially boils down to the
meaning of “several.” Specifically, does “several” mean two or more? Or does it mean more
than two?
Cook argues that “several” includes two; Endologix argues that it doesn’t. Cook derives
its position from the “Summary of the Invention,” which states that “[o]ne object of the invention
is to provide a self-expanding stent that permits the combination of several interlocked stents for
insertion into a body passageway.” (Dkt. 107-5 at 6-7; col. 2, l. 67 to col. 3, l. 1; emphasis
added). And, significantly, the “Description of Drawings” clearly identifies an assembly of two
interlocked stents as “an embodiment of the present invention.” (Dkt. 107-5 at 3, 7; col. 3, ll. 2021). When these portions of the patent are viewed in conjunction, Cook argues, the conclusion
that “several” can mean two is inescapable. The Court agrees.
19

Endologix emphasizes that the drafter could’ve used a clearer term – like “two or more”
or “plurality” – in lieu of “several.” Perhaps, but the intrinsic evidence still indicates that
“several” can mean two. For this reason, the Court sides with Cook in terms of the meaning of
“several.” However, as a matter of consistency in light of the Court’s prior constructions, the
Court believes it must use Endologix’s proposed construction, See Innova/Pure Water, 381 F.3d
at 1119, but with two caveats: (1) replace “more than two” with “two or more”; and (2) replace
“space” with “loop.” Accordingly, the Court construes “set of eyes formed at several of said
bends at one of said opposite ends” as “sections of wire each enclosing a loop and linked to the
ends of the straight sections by cusps or sharp bends at two or more of the bends at one of the
opposite ends of the second stent.”
Term 10: resiliently contractable
Claim Term

Endologix’s Construction

resiliently contractable No construction is necessary

Cook’s Construction
spring-like and capable of
contracting

Endologix does not meaningfully dispute Cook’s proposed construction of this term
found in Claim 12. Therefore, the Court adopts Cook’s proposed construction.
Term 11: “resiliently expandable into a second shape”
Claim Term

Endologix’s Construction

Cook’s Construction

resiliently expandable
into a second shape

No construction is necessary

spring-like and capable of
expanding into a second
shape

20

Endologix does not meaningfully dispute Cook’s proposed construction of this term
found in Claim 12. Therefore, the Court adopts Cook’s proposed construction.
Term 12: “in which the straight sections press against the walls . . .”
Claim Term

Endologix’s Construction

Cook’s Construction

in which the straight
sections press against
the walls of the body
passageway

in which every straight section of the where the straight sections are
first and second stents directly
capable of pressing against the
engages and applies force to the walls walls of a body passageway
of the body passageway

This term, used in Claim 12, boils down to the word “press.” Specifically, does term
require all the straight sections to actually press against the walls of the body passageway?
Endologix argues “yes,” whereas Cook argues that the straight sections must merely be capable
of pressing against the walls of the body passageway.
Endologix’s appears to have the stronger hand; its proposed construction is backed by the
plain language of the Claim, the summary of the invention, and the background of the invention.
See, e.g., Dkt. 107-5 at 6; col., ll. 37-40 (“Once within the body passageway, the stents are
resiliently expandable into a larger second shape wherein the straight sections press against the
walls of the passageway to maintain it open.”) (emphasis added); Id.; col. 1, ll. 30-34 (“the
sheath is withdrawn, thereby allowing the stent to expand in the passageway into its expanded
shape to hold the passageway open and enlarged . . . [t]hus, the Z-stent provides a self-expanding
means for maintaining an open passageway.”) (emphasis added). Moreover, the ‘568 patent
specification in the preferred embodiment section confirms that the stents expand to “hug the
vessel wall.” (Dkt. 107-6 at 6; col. 3, l. 18).

21

Cook counters that Claim 12 is an apparatus claim relating to structure and inherent
capability, not a method claim. Therefore, according to Cook, the straight sections only need to
be capable of pressing and need not actually press. See Spine Solutions, Inc. v. Medtronic
Sofamor Danek, Inc., 2008 WL 4831770, at *8 (W.D. Tenn. July 2, 2008) (“the terms at issue
here use active language to describe the capability of the apparatuses; they do not claim the
activity itself.”) (citation and internal quotations omitted). Moreover, Cook emphasizes that
Figure 5 of the ‘706 patent does not show a stent pressing against a wall.
This argument has some appeal, but the Court is not persuaded. The patent drafter
obviously knew how to convey capability, given his choice of the terms “expandable” and
“contractable,” which denote capability of expanding or contracting. But the drafter did not say
“pressable” or “capable of pressing” or “can be adapted to press against the walls.” Rather, the
drafter conveyed that the straight sections press against the walls. “Press” is not the same as
“capable of pressing” and it was the former that was chosen for Claim 12. Moreover, in Spine
Solutions, the court acknowledged that “a functional limitation . . . an attempt to define
something by what it does, rather than by what it is . . . is not, in and of itself, improper.” Spine
Solution, 2008 WL 4831770, at *8 (citations and internal quotations omitted). What is more, the
Court believes that Cook’s argument relating to Figure 5 is a red herring, given that it just shows
the embodiment by itself – it doesn’t show a vessel wall. For these reasons, the Court sides with
Endologix’s proposed construction.

22

Term 13: “said set of eyes of said second stent . . .”
Claim Term

Endologix’s Construction

every eye of the second stent
set of eyes of said
encloses a bend at one of the opposite
second stent are
engaged about said first ends of the first stent
wire at one of said
opposite ends

Cook’s Construction
the wire at the end of the first
stent is disposed through at
least two loops of the second
stent

This Claim 12 term relates to whether every eye must be engaged. The Court agrees with
Endologix’s argument that, without indicating a precise number, the entire set of eyes needs to
be engaged about the wire to satisfy this claim limitation. This position is reinforced by the
Figures depicting the embodiments of the ‘706 patent. Simply stated, all eyes (not just some) are
always connected. Moreover, in the Court’s view, Endologix’s proposed construction better
aligns with the plain meaning of the claim language. For these reasons, the Court adopts
Endologix’s proposed construction.
For the reasons set forth above, the disputed claim terms have the following meanings:
MEANING

CLAIM TERM
for combining a first and second self
expanding stent to form a stent assembly

for combining a first stent that spring expands
when a compressive force is removed and a
second stent that spring expands when a
compressive force is removed to form a stent
assembly

closed zig-zag configuration

zig-zag structure with the two ends of the wire
joined together

having an endless series of straight sections
joined at their ends by a plurality of bends

having a repeating pattern of straight sections
connected by bends and forming a
configuration that is generally cylindrical upon
expanding

23

forming a [first/second] stent from a
continuous [first/second] length of wire

forming a [first/second] self-expanding stent
from a single [first/second] length of wire

bends at one end defining eyes open

bends at one end defining sections of wire
largely enclosing a loop and linked to the ends
of the straight sections by cusps or sharp bends

engaging the eyes at the one end of the second
stent about bends at one end of the first stent

interlocking the eyes at the one end of the
second stent with bends at one end of the first
stent

closing the eyes at the one end of the second
stent

altering the shape of each open eye to
completely enclose a loop

endless series of straight sections having
opposite ends, said straight sections being
joined by bends at said opposite ends

repeating pattern of straight sections connected
by bends and forming a configuration that is
generally cylindrical upon expanding, where
adjacent ends of the straight sections are joined
by a bend

set of eyes formed at several of said bends at
one of said opposite ends

sections of wire each enclosing a loop and
linked to the ends of the straight sections by
cusps or sharp bends at two or more of the
bends at one of the opposite ends of the second
stent

resiliently contractable

spring-like and capable of contracting

resiliently expandable into a second shape

spring-like and capable of expanding into a
second shape

in which the straight sections press against the in which every straight section of the first and
walls of the body passageway
second stents directly engages and applies
force to the walls of the body passageway

24

said set of eyes of said second stent are
engaged about said first wire at one of said
opposite ends

every eye of the second stent encloses a bend
at one of the opposite ends of the first stent

B. The ‘777 patent
As mentioned, the ‘777 patent is directed to a delivery device involving the delivery of a
self-expanding prosthesis. Prior to the ‘777 patent, delivery systems were ill-suited for AAA
repairs. For instance, they were too large to be inserted through remote vessels in a patient’s leg,
used sharp and traumatic structures that could damage vessels during a procedure, and were
subject to inaccurate positioning. The ‘777 patent helped ameliorate these problems, reducing
the risk of vessel damage and allowing for less complicated and more accurate prosthesis
placement. The original patent application, for what later became the ‘777 patent, was filed in
1991 and the ‘777 patent was issued in 1998.
Generally, the delivery device contemplated by the ‘777 patent involves a self-expanding
prosthesis that is positioned on a carrier, which holds the prosthesis in position during delivery.
The carrier is inserted into a tubular introducer sheath. The prosthesis is carried on a region of
the carrier called the stem. The sheath is inserted through a small incision in the patient’s
femoral artery and snaked through the patient’s arteries to the aorta where the self-expanding
prosthesis is released. A three dimensional example of the ‘777 patent is depicted below.

25

Cook alleges that Endologix is infringing the ‘777 patent through the sale of its Intuitrak delivery
system.
1. Claims
Cook asserts Claims 1 and 21-30 of the ‘777 patent.3 Given the large number of Claims
at issue, the Court will not recite them. Instead, the Court will immediately turn to the disputed
terms.
2. Disputed Terms
Each disputed term in the ‘777 patent is addressed in turn below.

3

On July 20, 2010, the PTO issued a reexamination certificate, confirming the patentability of
the delivery system. In doing so, the PTO confirmed the patentability of amended Claim 1 and
over 10 other Claims. Additionally, the PTO confirmed the patentability of the device recited in
Claim 11, but, in doing so, required Cook to add that the “delivery system is characterized by
absence of a guiding catheter” in light of the prior art.
26

Term 1: “self expanding prosthesis” (preamble of Claims 1, 21-24, 30)
Claim Term

Endologix’s Construction

Cook’s Construction

self expanding
prosthesis

No construction necessary

a graft conduit that spring
expands when a compressive
force is removed

For the ‘706 patent, the Court has already construed “self expanding” as something that
spring expands when a compressive force is removed. That same reasoning applies for this term
in the ‘777 patent. The Court must now determine if it is appropriate to construe “prosthesis.”
In light of the ‘777 patent’s background and summary sections, Cook argues that the “prosthesis”
means “graft conduit.” (Dkt. 108-1 at 21; col. 1, ll. 42-43) (“The prosthetic graft of the invention
will provide a resilient conduit . . .”) (emphasis added); see also Dkt. 108-1 at 22; col. 3, ll. 49-50
(“[t]he present invention provides a transluminal graft prosthesis that can be safely and precisely
positioned”) (emphasis added); see also SciMed, 242 F.3d at 1343 (construing term to include
feature characterized as “the present invention”)). The Court respectfully disagrees. The phrase
“graft conduit” is never actually used in the specification. Moreover, in the Court’s view, the
term “prosthesis” needs no special construction. See Phillips, 415 F.3d at 1314. For these
reasons, the Court construes “self expanding prosthesis” as “a prosthesis that spring expands
when a compressive force is removed.”

27

Term 2: “introducer sheath” (Claims 1, 21-24, 30)
Claim Term

Endologix’s Construction

Cook’s Construction

introducer sheath

a hollow tube extending from outside
the body to define a conduit into and
through a vessel in the human body

an outermost sheath defining a
conduit between a body lumen
to be treated and the outside
of the body

The parties agree that an “introducer” sheath defines a conduit. Unfortunately, however,
that is where the agreement ends. Cook argues that its proposed construction is better because it
gives real meaning to the term “introducer,” which must mean a sheath “in direct contact with
the vasculature.” (Dkt. 121 at 20). Endologix counters that Cook’s use of the term “outermost”
has no basis and that the term “sheath” needs to be construed.
With respect to the need to construe “sheath,” the Court agrees with Endologix. The ’777
patent specification describes the introducer sheath as “tubular in form” (Dkt. 108-1 at 25; col.
10, l. 49) and “a tubular structure (Dkt. 108-1 at 26; col. 11, l. 15). Moreover, the sheath must be
a “hollow tube” to receive the “carrier”: “The tubular carrier 21 fits inside the introducer sheath
4.” (Dkt. 108-1 at 25; col. 10, ll. 49-50). Thus, in the Court’s view, construing sheath as a
“hollow tube” is appropriate.
Further, the Court agrees with Endologix that the use of the term “outermost” is
confusing, as it implies the existence of some “innermost” sheath. Cook claims that Endologix’s
proposed construction fails to explain what “introducer” means. However, the Court is not
persuaded, as Endologix’s proposed construction states that the sheath “define[s] a conduit into
and through a vessel in the human body.” In the Court’s view, this language adequately captures
the meaning of the word “introducer.” This position is supported by the ‘777 patent
28

specification, which describes the introducer sheath as “a large conduit between the arterial
circulation and the outside of the body.” (Dkt. 108-125; col. 10, ll. 23-24). For these reasons, the
Court sides with Endologix’s proposed construction.
Terms 3: “sheath bore of a substantially constant diameter” (Claim 1)
Claim Term

Endologix’s Construction

Cook’s Construction

sheath bore of a
substantially constant
diameter extending
longitudinally
therethrough

an internal diameter that varies by no
more than manufacturing tolerances
throughout the entire length of the
introducer sheath

the sheath bore has a
substantially constant
diameter along its length

Term 4: “uniform sheath bore” (Claims 21-24, 30)
Claim Term

Endologix’s Construction

Cook’s Construction

uniform sheath bore
extending
longitudinally
therethrough

an internal diameter that varies by no
more than manufacturing tolerances
throughout the entire length of the
introducer sheath

the sheath bore has a uniform
diameter along its length

These terms are grouped together because they cover similar terrain.4 The parties’
proposed constructions differ in two key ways. First, Endologix contends that the term “bore”
should be construed to denote the “internal diameter” of the sheath, and, on this point, Cook
doesn’t put up much of a fight. Therefore, the Court will construe “bore” as “internal diameter.”
Second, Endologix contends that the terms “substantially constant” and “uniform” should
be construed. However, the Court is not persuaded, given the relatively plain meaning of these
terms. See Phillips, 415 F.3d at 1314. Further, Endologix’s proposed construction – involving
4

Although the parties disagree about the meaning of “substantially constant” and “uniform,” they
agree that, once construed, those terms essentially mean same thing. (Dkt. 118 at 29).
29

“manufacturing tolerances” – is unsupported by the intrinsic evidence and would amount to a
rather marked deviation from the ordinary meaning of these terms. Therefore, the Court adopts
something of a hybrid approach. The disputed terms will be construed as “the sheath has an
internal diameter that is substantially constant/uniform along its length.”
Term 5: “central carrier” (Claims 1, 21-24, 30)
Claim Term

Endologix’s Construction

Cook’s Construction

central carrier

a structure within the introducer
sheath that carries the prosthesis

a structure carried within the
introducer sheath

Both proposed constructions describe the central carrier as “a structure within the
introducer sheath.” However, the parties dispute whether the term “central carrier” should be
construed to “carr[y] a prosthesis.” Endologix argues that it should, while Cook counters that it
would be inappropriate to read “prosthesis” into “central carrier” because many of the claims,
such as 21-23, “do not positively recite a self-expanding prosthesis, and such a construction
would render the positive recitation of a self-expanding prosthesis superfluous in those claims
that do.” (Dkt. 107 at 32).
This argument is well-taken, but the Court respectfully disagrees. The preamble of every
asserted claim refers to “a self expanding prosthesis delivery system.” (Dkt. 108-2 at 4-5).
Moreover, as a practical matter, a “carrier” presumably “carries” something. In its reply brief,
Cook conceded that “the central carrier is a structure for carrying a prosthesis . . .”. (Dkt. 121 at
21). In sum, Endologix’s position better aligns with the plain language of the claims and the
intrinsic evidence.

30

Term 6: “vascular dilator head region” and “having a fixed shape” (Claims 1, 21-24,
30)
Claim Term

Endologix’s Construction

Cook’s Construction

vascular dilator head
region

An end of the central carrier that
expands the vessel during the
introduction of the sheath into the
vessel

an elongate region at an end
of the central carrier that does
not inflate

having a fixed shape
a shape that cannot change

For this term, the parties wage battle on two key grounds. First, they dispute the
construction of “dilator.” Specifically, Endologix contends that the construction should clarify
the dilator’s function. After all, a dilator must “dilate” something. Cook, on the other hand,
contends that Endologix’s proposed construction reads a method step – “expands the vessel
during the introduction of the sheath into the vessel” – into a purely structural claim. See, e.g.,
Baldwin Graphic Systems, Inc. v. Siebert, Inc., 512 F.3d 1338, 1344 (Fed. Cir. 2008) (“Courts
must generally take care to avoid reading process limitations into an apparatus claim.”).
The Court believes that Endologix has the stronger hand. As the Federal Circuit recently
noted, “it is entirely proper to consider the functions of an invention in seeking to determine the
meaning of particular claim language.” ICU Medical, Inc. v. Alaris Medical Systems, Inc., 558
F.3d 1368, 1375-76 (Fed. Cir. 2009) (emphasis added; adding functional language of “for
piercing the seal” to the term “spike” was appropriate because it defined the degree to which the
spike must be pointed); see also Funai Elec. Co., Ltd. v. Daewoo Electronics. Corp., 616 F.3d
1357, 1366 (Fed. Cir. 2010) (“The use of . . . functional language to construe and explain a claim
term is not improper. A description of what a component does may add clarity and
31

understanding to the meaning and scope of the claim.”). At bottom, the Court believes that
construing a term of an apparatus claim using some functional language is appropriate, and does
not amount to erroneously conflating a method claim with an apparatus claim. Cook, by
contrast, reads “dilator” completely out of the claims. For these reasons, the Court adopts
Endologix’s construction of “vascular dilator head region.”
Second, the parties dispute the meaning of “having a fixed shape.” Cook contends that
this term was defined during the prosecution history (i.e. the back and forth between the patent
attorney and the patent examiner) as “does not inflate.” Indeed, “the record before the [PTO] is
often of critical significance in determining the meaning of the claims.” Vitrionics Corp. v.
Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed. Cir. 1996). Endologix, naturally, balks at Cook’s
proposed construction, arguing that it runs contrary to the plain language of the claim. To be
sure, common sense suggests that “fixed” and “non-inflatable” are separate and distinct concepts.
The Court agrees with Endologix that the prosecution history does not compel a
departure from the plain meaning of “having a fixed shape.” The prosecution history established
that the dilator head both (1) has “a fixed shape” and (2) “does not employ an inflatable balloon.”
But the prosecution history did not unequivocally redefine “fixed shape” to mean the lack of an
inflatable balloon.5 Although a patent applicant may act as his own lexicographer and deviate
from the ordinary meaning of words, he “must clearly express that intent.” Helmsderfer v.
Bobrick Washroom Equipment, Inc., 527 F.3d 1379, 1381 (Fed. Cir. 2008). Here, the patentee

5

To bolster its position that “fixed shape” means “does not inflate,” Cook highlights the
prosecution history statement that “the dilator head region has a fixed shape totally unlike the
balloon dilator element 64 of Lazarus . . .”. (Dkt. 109-3 at 3). The Court is not persuaded.
Having a fixed shape is indeed “totally unlike” being inflatable, but, of course, this does not
mean that “fixed” means “non-inflatable.”
32

did not manifest such a clear and unmistakable intent. For these reasons, Endologix’s
construction of “having a fixed shape” is appropriate.
Term 7: “portion mating with and approximating” (Claims 1, 21-24, 30)
Claim Term

Endologix’s Construction

Cook’s Construction

portion mating with
and approximating said
[substantially constant
diameter of
said/uniform] sheath
bore

portion of the vascular dilator head
region in close intimate contact with
and sized to fit the sheath bore so that
there is no gap between the outer
diameter of the dilator head and the
inner diameter of the sheath

a portion of the vascular
dilator head region contacts
the sheath bore and there is no
discernable annular gap
between the outer diameter of
the dilator head portion and
the inner diameter of the
introducer sheath

The parties’ dispute boils down to the meaning of “mating with and approximating.”
Cook initially argued that the phrase “close intimate contact” is unnecessary prolix. However,
Cook later softened its stance at oral arguments, conceding that it did not object to the inclusion
of this language, since it was used in arguing for patentability during the reexamination. (Dkt.
139 at 125). Along similar lines, the Court is persuaded that Cook’s inclusion of the phrase
“discernable annular gap” is appropriate. This language tracks the definition provided during the
reexamination proceedings and the related declaration of Mark A. Farber M.D. (Dkt. 118-18 at 8,
29).
Finally, the Court believes that Endologix’s proposed construction of “approximating” as
“sized to fit” is misguided; notably, it stands in stark contrast to the definition of
“approximating” provided during the reexamination – “close in size.” That said, Cook appears
to read “approximating” out of the claims altogether. For these reasons, the Court construes
“portion mating with and approximating said [substantially constant diameter of said/uniform]
33

sheath bore as “portion of the vascular dilator head region in close intimate contact with and
close in size to the sheath bore and there is no discernible annular gap between the outer
diameter of the dilator head portion and the inner diameter of the introducer sheath.”
Term 8: “shaft region approximating” (Claims 1, 21-24, 30)
Claim Term

Endologix’s Construction

Cook’s Construction

shaft region
approximating said
[substantially constant
diameter of
said/uniform] sheath
bore

the end of the central carrier opposite
the vascular dilator head region sized
to fit the sheath bore

elongate region of the central
carrier having an outer
diameter that is in close
proximity with the inner
diameter of the introducer
sheath

The parties dispute the meaning of “shaft region approximating” on numerous grounds.
First, the parties once again dispute the meaning of “approximating.” Endologix construes
“approximating” as “sized to fit,” which the Court rejected directly above. Cook uses the phrase
“in close proximity,” which strikes the Court as unfounded. Because the Court is uncomfortable
with both approaches, it will embrace the meaning of “approximating” adopted above: That is,
“close in size.” Accordingly, the Court finds that, under the circumstances, the relevant term
language should be construed as “having an outer diameter that is close in size to the inner
diameter of the introducer sheath.” This position is reinforced by the specification of the ‘777
patent: “The internal diameter of the introducer sheath corresponds to the external diameter of
the central carrier along two regions.” (Dkt. 108-1 at 28; col. 15, ll. 47-49; emphasis added).
Second, the parties dispute whether the construction should specify the location of the
shaft region on the central carrier. Specifically, Endologix proposes that the shaft region
necessarily means “the end of the central carrier opposite the vascular dilator head region.” The
34

Court agrees. The ‘777 specification states that the “stem region [is] positioned between the
head and shaft regions” (Dkt. 108-1 at 23; col. 5, ll. 48-49) and, significantly, that “[o]ne region
is located caudally [towards patient’s feet] at carrier shaft 218, and the other region is located
cranially [towards patient’s head] at carrier head 219. In between these two regions is much
narrower carrier stem region 220.” (Dkt. 108-1 at 28; col. 15, ll. 49-52).
In the end, the Court adopts a hybrid of the two proposed constructions, construing “shaft
region approximating said [substantially constant diameter of said/uniform] sheath bore” as “the
end of the central carrier opposite the vascular dilator head region having an outer diameter that
is close in size to the inner diameter of the introducer sheath.”
Term 9: “stem region” (Claims 1, 21-24, 30)
Claim Term

Endologix’s Construction

Cook’s Construction

stem region

a narrower section of the central
carrier

positioned between said
head and shaft regions
and being smaller than
said [substantially
constant diameter of
said/uniform] [sheath]
bore for

no construction needed

an elongate region of the
central carrier disposed
between the vascular dilator
head and shaft regions, having
an outer diameter that is less
than the diameter of the
sheath bore along its length,
and the stem region is sized so
that a self-expanding
prosthesis can be positioned
around the stem region with
the stem disposed within a
bore of the prosthesis

positioning coaxially a
self-expanding
prosthesis therearound

mounting the self expanding
prosthesis on the stem region so that
they share the same longitudinal axis

35

Each component of this term is addressed in turn. First, the Court will construe “stem
region.” Endologix construes it as “a narrower section of the central carrier,” while Cook
construes it as “an elongate region of the central carrier.” The Court agrees with Endologix that
Cook’s use of “elongate” is not particularly helpful. Moreover, Endologix’s description of the
stem region as a “narrower section” is consistent with the ‘777 patent specification, which
provides “[t]he narrower segment of the central carrier between carrier head 219 and carrier shaft
218 is carrier stem 220.” (Dkt. 108-1 at 28; col. 16, ll. 19-21). Cook’s own brief concedes that
“[t]he stem region is narrower so that a self-expanding prosthesis can be positioned around the
stem region and in the sheath bore . . .”. (Dkt. 107 at 35; emphasis added). Accordingly, the
Court adopts Endologix’s proposed construction of “stem region.”
Second, the Court agrees with Endologix that the phrase “positioned between said head
and shaft regions” need not be construed. Replacing the word “positioned” with “disposed” – as
Cook proposes – is not particularly helpful, and the meaning of this phrase is clear.
Third, the parties also dispute whether the term “and being smaller than said
[substantially constant diameter of said/uniform] [sheath] bore for” needs to be construed. Given
the Court’s construction of “stem region” as a “narrower section,” the Court believes Cook’s
proposed language is unnecessary. Accordingly, the Court agrees with Endologix that this term
need not be construed.
Fourth, following Cook’s reply brief, the parties essentially agree that “coaxially” means
that “the prosthesis and stem share a common longitudinal axis.” (Dkt. 121 at 23; emphasis in
original). Moreover, the Court agrees with Endologix that Cook’s proposed construction does
not explain the inclusion of the requirement that “the stem be disposed within a bore of the
prosthesis.” Therefore, in the Court’s view, the only remaining dispute involves the use of the
36

phrase “can be positioned” (Cook’s construction) versus “mounting” (Endologix’s construction).
The Court believes that Cook’s proposal stays true to the claim language, which states “for
positioning.”
Accordingly, the term “stem region positioned between said head and shaft regions and
being smaller than said [substantially constant diameter of said/uniform] [sheath] bore for
positioning coaxially a self-expanding prosthesis therearound” as “a narrower section of the
central carrier positioned between said head and shaft regions and being smaller than said
[substantially constant diameter of said/uniform] [sheath] bore, and the stem region is sized so
that a self-expanding prosthesis can be positioned around the stem region so that the prosthesis
and the stem share a common longitudinal axis.”
Term 10: “around said stem region”
Endologix does not dispute Cook’s proposed interpretation of this term. Accordingly, the
Court construes “around said stem region” as “the self-expanding prosthesis is positioned around
the stem region with the stem disposed within a bore of the prosthesis.”
Term 11: “configured to span” (Claims 1, 24)
Claim Term

Endologix’s Construction

Cook’s Construction

graft configured to
span an aortic
aneurysm

graft configured to engage the walls
of the aorta beyond the two ends of
the aneurysm

a graft sized so that it can be
used to repair an aortic
aneurysm

The parties hotly contest this term. Relying on Flexhead Industries, Inc. v. Easyflex, Inc.,
2008 WL 4813797 (D. Mass. Nov. 3, 2008), Cook argues that the term “configured to span”
merely means that the graft should have a size suitable for aortic aneurysm repair. See id. at *7
37

(construing “configured to receive the fire protection sprinkler head” as “set up in a particular
way to receive the fire protection sprinkler head”). But this proposed construction creates more
questions than answers: Namely, what is a suitable graft size? In the Court’s view, Cook’s
construction altogether ignores the word “span.”
The intrinsic and extrinsic evidence generally support Endologix’s proposed construction.
Tellingly, the ‘777 patent specification states that “[t]he prosthetic graft of this invention will
provide a resilient conduit, bridging the aneurysm and reducing the risk of rupture . . .”. (Dkt.
108-1 at 21; col. 1, ll. 42-44; emphasis added). Moreover, as Endologix highlights, the common
definition of span is “to extend across.”
Cook maintains that Endologix’s use of the word “engage” is improper. However, the
Court respectfully disagrees. Figure 15 of the ‘777 patent “shows a graft implanted in the aorta
on either side of an aneurysm.” (Dkt. 108-1 at 23; col. 6, ll. 48-49) (emphasis added). Moreover,
the ’777 patent specification describes the need “to provide a secure arterial wall for the
attachment of the proximal . . . end of the graft . . .”. (Dkt. 108-1 at 27; col. 13, ll. 40-41)
(emphasis added). Given this intrinsic evidence, the Court believes that Endologix’s use of
“engage” is appropriate. That said, the Court agrees with Cook that “an aortic aneurysm” –
rather than “the aortic aneurysm” – stays true to the claim language. Accordingly, the Court
construes, “graft configured to span an aortic aneurysm” as “graft configured to engage the walls
of an aorta beyond the two ends of an aneurysm.”
Term 12: spring assembly (Claims 1, 24-29)
Endologix has adopted Cook’s proposed construction of this term. Therefore the Court
will construe “spring assembl[y/ies] as “an assembly that spring expands when a compressive
force is removed.
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Term 13: “continuous wire” (Claims 1, 29)
Claim Term

Endologix’s Construction

Cook’s Construction

a continuous wire

a single wire with joined ends

made from a single piece of
wire having a series of zigzags

in the shape of a zig-zag no construction necessary
with multiple elbows

The parties dispute this term on two grounds. First, does the wire always have joined
ends? The plain meaning of “continuous” suggests “yes.” It is, after all, difficult to conceive
how one could make a wire “continuous” without joining its ends. Cook’s proposed construction
– which essentially just replaces “continuous” with “single” – ignores the ordinary meaning of
“continuous.” The ‘777 specification reinforces this position, providing that “[t]he two ends of
the piece of bent wire are permanently attached end-to-end so as to form a circular structure.”
(Dkt. 108-1 at 24; col. 8, ll. 12-13; emphasis added). Cook counters that Endologix is merely
importing a limitation from an example into the Claims. Tellingly, however, Cook never really
explains why “continuous” should mean “single.” Therefore, the Court construes “a continuous
wire” as “a single wire with joined ends.”
Second, the parties dispute whether “in the shape of a zig-zag with multiple elbows”
needs to be construed. The Court believes that Cook’s construction helps clarify the meaning of
this language, and Endologix does not meaningfully disagree. Accordingly, the Court construes
“a continuous wire in the shape of a zig-zag with multiple elbows” as “a single wire with joined
ends having a series of zig-zags.”

39

Term 14: “aperture longitudinal member” (Claim 1, 27-29)
Thankfully, the parties now agree on these constructions. Therefore, the Court construes:
(1) “first assembly comprising an aperture” as “the first spring assembly comprises a structure
defining an aperture”; (2) “second assembly comprising a longitudinal member slidably disposed
through said aperture” as “the second spring assembly comprises an elongate structure that
extends through the aperture of the first spring assembly, and is slidably connected to the first
spring assembly via the aperture”; and (3) “portion with a dimension that is larger than said
aperture to prevent disengagement of said first and second spring assemblies” as “a portion of
the longitudinal member has a dimension that is larger than the aperture to prevent the largerdimension portion from passing through the aperture.”
Term 15: “seal” (Claims 1, 21)
Claim Term

Endologix’s Construction

Cook’s Construction

seal disposed at a
proximal end of said
introducer sheath

a seal between the introducer sheath
and the central carrier, located on the
open end of the introducer sheath
closest to the surgeon

a seal disposed at a
downstream end of the
introducer sheath

The parties’ dispute centers on the word “proximal” (i.e. the location of the seal).
Although the parties do not dispute what the proximal end of the sheath is, they dispute the best
construction of that word. Cook’s proposed construction simply replaces “proximal” with
“downstream.” Indeed, the ‘777 patent specification makes clear that downstream is
synonymous with proximal. (See, e.g., Dkt. 108-1 at 23; col. 6, ll. 42-43) (“FIG. 13 is a
longitudinal cross-sectional view of the proximal (downstream) end of the introducer sheath”)
(emphasis added). Endologix’s more detailed proposed construction is flawed, as, in the Court’s
40

view, it attempts to read preferred embodiments and non-limiting prosecution history into the
claim language. In the end, the Court believes that Cook’s proposed construction best aligns
with both the claim language and the intrinsic evidence.
Term 16: absence of a guiding catheter (Claims 1, 23)
Claim Term

Endologix’s Construction

Cook’s Construction

is characterized by the
absence of a guiding
catheter

does not have a hollow tube for
guiding devices through a vessel in
the human body

the delivery system can be
introduced into the body
lumen from the outside of the
body without having to guide
it to the treatment site through
a catheter

This phrase was added to the ‘777 patent as part of the reexamination proceedings.
Specifically, the patent examiner stated that the references that Endologix submitted to provoke
the reexamination proceedings, among others, “fail[] to teach a delivery system that does not
require a guiding catheter as claimed nor would it be obvious to include such a feature…”. (Dkt.
107 at 41). Essentially, the parties’ dispute boils down to whether: (1) the delivery system is
capable of being used without a guiding catheter (essentially, Cook’s proposed construction); or
(2) the delivery system simply does not have a guiding catheter (Endologix’s construction).
Stated differently, Cook’s proposed construction implies permissiveness: That the delivery
system still can be used with a guiding catheter, even though it doesn’t require one.
To bolster its argument against permissiveness, Endologix relies on Union Carbibe
Chems. & Plastics Technology Corp. v. Shell Oil Co., 308 F.3d 1167 (Fed. Cir. 2002) for the
proposition that “characterized by” means that the delivery system is distinguished from others
by this essential characteristic. Id. at 1177. Union Carbibe is not directly on-point, though. In
41

that case, the Federal Circuit ultimately construed the phrase “characterizable by” to mean
“capable of being described by.” Id. However, in doing so, the court acknowledged the
difference between the plain meaning of “characterizable” and the plain meaning of
“characterized.” Indeed, the plain meaning of “characterized by” is “to describe the essential
character or quality of . . . to be a distinguishing characteristic of.” Id. (citations omitted).
Obviously, the distinction between characterized by and characterizable by is significant; it
amounts to the difference between always having a characteristic versus merely being capable
of having a characteristic.
Tellingly, here, the patentee chose “characterized by.” Thus, rather than merely being
capable of having “the absence of a guiding catheter,” the delivery device is defined by “the
absence of a guiding catheter” – i.e. it never makes use of a guiding catheter. For this reason, the
Court sides with Endologix’s proposed construction.
Moreover, this position is reinforced by the prosecution history, in which Cook went to
great lengths to distinguish its delivery system from Garza. Specifically, Mark Farber M.D.’s
declaration states that “Claim 25 requires that the delivery system has an introducer sheath, a
central carrier, but no guiding catheter . . . Garza clearly has a guiding catheter 78.6 In fact, the
guiding catheter is described as an integral component of Garza’s delivery system…”. (Dkt. 11818 at 36) (emphasis added).
That said, the Court does not adopt Endologix’s entire proposed construction, as it sees
no reason to construe “catheter,” given its plain meaning. Moreover, the intrinsic evidence does
not support Endologix’s proposed construction of “hollow tube.” For these reasons, the Court

6

Claim 25 in the reexamination proceeding issued as Claim 23 of the ‘777 Reexamination
Certificate.
42

construes “is characterized by the absence of a guiding catheter” as “does not have a catheter
for guiding devices through a vessel in the human body.”
Miscellaneous
The parties have apparently resolved many of their other claim term disputes, including:
lip (Claim 22); twist prevention double lumen catheter (Claim 31); cross femoral guide (Claim
31); catheter attached to a caudal end of said contralateral graft limb (Claim 32); and guidewire
(Claim 33). Therefore, the Court need not construe these terms.
For the reasons set forth above, the disputed claim terms in the ‘777 patent have the
following meanings:
CLAIM TERM

MEANING

self expanding prosthesis

a prosthesis that spring expands when a
compressive force is removed

introducer sheath

a hollow tube extending from outside the body
to define a conduit into and through a vessel in
the human body

sheath bore of a substantially constant diameter the sheath has an internal diameter that is
extending longitudinally therethrough
substantially constant along its length
uniform sheath bore extending longitudinally
therethrough

the sheath has an internal diameter that is
uniform along its length

central carrier

a structure within the introducer sheath that
carries the prosthesis

vascular dilator head region having a fixed
shape

an end of the central carrier that expands the
vessel during the introduction of the sheath
into the vessel having a shape that cannot
change

43

portion mating with and approximating said
[substantially constant diameter of
said/uniform] sheath bore

portion of the vascular dilator head region in
close intimate contact with and close in size to
the sheath bore and there is no discernible
annular gap between the outer diameter of the
dilator head portion and the inner diameter of
the introducer sheath

shaft region approximating said [substantially
constant diameter of said/uniform] sheath
bore

the end of the central carrier opposite the
vascular dilator head region having an outer
diameter that is close in size to the inner
diameter of the introducer sheath

stem region

a narrower section of the central carrier

positioned between said head and shaft
regions and being smaller than said
[substantially constant diameter of
said/uniform] [sheath] bore for
Positioning coaxially a self-expanding
prosthesis therearound

No construction needed

and the stem region is sized so that a selfexpanding prosthesis can be positioned around
the stem region so that the prosthesis and the
stem share a common longitudinal axis

around said stem region

the self-expanding prosthesis is positioned
around the stem region with the stem disposed
within a bore of the prosthesis

configured to span

graft configured to engage the walls of an aorta
beyond the two ends of an aneurysm

spring assembl[y/ies]

an assembly that spring expands when a
compressive force is removed

a continuous wire in the shape of a zig-zag
with multiple elbows

a single wire with joined ends having a series
of zig-zags

first assembly comprising an aperture

the first spring assembly comprises a structure
defining an aperture

44

second assembly comprising a longitudinal
the second spring assembly comprises an
member slidably disposed through said aperture elongate structure that extends through the
aperture of the first spring assembly, and is
slidably connected to the first spring assembly
via the aperture
portion with a dimension that is larger than said
aperture to prevent disengagement of said first
and second spring assemblies

a portion of the longitudinal member has a
dimension that is larger than the aperture to
prevent the larger-dimension portion from
passing through the aperture

seal disposed at a proximal end of said
introducer sheath

a seal disposed at a downstream end of the
introducer sheath

is characterized by the absence of a guiding
catheter

does not have a catheter for guiding devices
through a vessel in the human body

CONCLUSION
For the reasons set forth above, the disputed claim terms have the meaning set out in this
order.

SO ORDERED.
08/16/2011
Date: ____________

________________________
Hon. Tanya Walton Pratt, Judge
United States District Court
Southern District of Indiana

Distribution attached.
45

Distribution to:
Daniel K. Burke
HOOVER HULL LLP
[e-mail],[e-mail]
Joseph S. Cianfrani
KNOBBE MARTENS OLSON & BEAR, LLP
[e-mail]
Kelly J. Eberspecher
BRINKS HOFER GILSON & LIONE
[e-mail]
John David Evered
KNOBBE MARTENS OLSON & BEAR, LLP.
[e-mail],[e-mail]
Andrew W. Hull
HOOVER HULL LLP
[e-mail],[e-mail]
Bradley G. Lane
BRINKS HOFER GILSON & LIONE
[e-mail],[e-mail]
Danielle Anne Phillip
BRINKS HOFER GILSON & LIONE
[e-mail],[e-mail]
John B. Sganga , Jr
KNOBBE MARTENS OLSON & BEAR, LLP.
[e-mail]
Joshua J. Stowell
KNOBBE MARTENS OLSON & BEAR, LLP.
[e-mail]

46