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Angioscore, Inc. v. Trireme Medical, Inc.

United States District Court, N.D. California

June 25, 2014

ANGIOSCORE, INC., Plaintiff,
v.
TRIREME MEDICAL, INC., et al., Defendants

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[Copyrighted Material Omitted]

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For Angioscore, Inc., Plaintiff: James W. Geriak, LEAD ATTORNEY, Andre De La Cruz, Sheppard Mullin Richter & Hampton LLP, Costa Mesa, CA; Steven Mark Hanle, Sheppard Mullin Richter Hampton, Costa Mesa, CA.

For Trireme Medical, Inc., formerly known as Trireme Medical, Inc., Eitan Konstantino, Defendants: Sheila Neha Swaroop, LEAD ATTORNEY, Joseph Robert Re, Knobbe Martens Olson & Bear LLP, Irvine, CA; John Stuart Claassen, CLAASSEN, Professional Corporation, Oakland, CA; Joshua Jan Stowell, Knobbe Martens Olson and Bear, LLP, Irvine, CA; William Gerard von Hoffmann, III, Knobbe, Martens, Olson, Bear, LLP, Irvine, CA.

For Quattro Vascular PTE Ltd., QT Vascular Ltd., formerly known as QT Vascular PTE. Ltd., Defendants: Sheila Neha Swaroop, LEAD ATTORNEY, Knobbe Martens Olson & Bear LLP, Irvine, CA; John Stuart Claassen, CLAASSEN, Professional Corporation, Oakland, CA.

For Trireme Medical, Inc., Eitan Konstantino, Counter-claimants: Sheila Neha Swaroop, LEAD ATTORNEY, Joseph Robert Re, Knobbe Martens Olson & Bear LLP, Irvine, CA; Joshua Jan Stowell, Knobbe Martens Olson and Bear, LLP, Irvine, CA; William Gerard von Hoffmann, III, Knobbe, Martens, Olson, Bear, LLP, Irvine, CA.

For Angioscore, Inc., Counter-defendant: James W. Geriak, LEAD ATTORNEY, Andre De La Cruz, Sheppard Mullin Richter & Hampton LLP, Costa Mesa, CA; Steven Mark Hanle, Sheppard Mullin Richter Hampton, Costa Mesa, CA.

For Quattro Vascular PTE Ltd., QT Vascular Ltd., Counter-claimants: Sheila Neha Swaroop, LEAD ATTORNEY, Knobbe Martens Olson & Bear LLP, Irvine, CA.

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Order Construing Claims in Dispute; Granting in Part and Denying in Part Defendants' Motion for Summary Judgment of Non-Infringement

YVONNE GONZALEZ ROGERS, UNITED STATES DISTRICT COURT JUDGE.

INTRODUCTION

At the heart of this patent action is an angioplasty device named " Chocolate."

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Defendant Eitan Konstantino, an inventor of angioplasty devices, worked for plaintiff AngioScore, Inc. (" AngioScore" ), a company that makes and sells angioplasty devices. Later, he started his own company, TriReme Medical, Inc., which has since reorganized as defendant TriReme Medical, LLC (" TriReme" ). TriReme makes and sells the Chocolate device. AngioScore's operative Supplemental and Second Amended Complaint alleges that Chocolate infringes United States Patent No. 7,691,119, which AngioScore owns by assignment. (Dkt. No. 118 ¶ ¶ 14, 19; id., Ex. A (" '119 Patent" ).) AngioScore brings a single claim of patent infringement against TriReme, Konstantino, and two corporate entities associated with TriReme, namely, Quattro Vascular Pte Ltd. (" Quattro" ), and QT Vascular Ltd. (f/k/a QT Vascular Pte. Ltd.) (" QTV" ).[1] Defendants answered, asserting counterclaims for (1) a declaration of noninfringement of the '119 Patent, (2) a declaration of invalidity of the '119 Patent, (3) intentional and (4) negligent interference with prospective economic advantage (asserted by TriReme alone), (5) defamation, (6) false advertising under the Lanham Act, 15 U.S.C. section 1125, (7) unfair competition in violation of California's Business and Professions Code section 17200, and (8) unfair competition under the common law. (Dkt. No. 127.)

Now before the Court is a motion for summary judgment filed by TriReme and Konstantino (herein, " Defendants" ) seeking a declaratory judgment that Chocolate does not infringe the '119 Patent. (Dkt. No. 131 (" Motion" ).) The Motion presents two issues: (1) the proper construction of three disputed terms in the '119 Patent's only independent claim and (2) Chocolate's alleged infringement of the disputed terms once properly construed. The Motion is fully briefed, and the Court heard oral argument on February 14, 2014. (Dkt. Nos. 138-4 (" Opp'n" ), 147 (" Reply" ), 181 (" Tr." ).)[2]

In Section I of this Order, the Court summarizes relevant facets of the prior art and the patent-in-suit. In Section II, the Court engages in claim construction as to the three disputed terms. The Court concludes that the terms have the following meanings:

Term

Construction

end

" part of the device where the stent, catheter shaft, and

balloon connect"

longitudinal expansion

" reshaping by straightening"

attached

Ordinary and customary meaning

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The Court then turns to the summary judgment analysis in Section III. The Court concludes that, with respect to the disputed terms, either triable issues of material fact exist or Defendants have failed to carry their burden of showing their entitlement to judgment as a matter of law. Defendants have established, however, their entitlement to summary judgment on three points: (a) the struts of Chocolate do not literally infringe the '119 Patent's claim of struts that connect from " end" to " end" of the hypo tube; (b) AngioScore is barred from asserting the doctrine of equivalents to prove infringement of the " longitudinal expansion" limitation in claim 1 of the '119 Patent; and, similarly, (c) AngioScore is barred from asserting the doctrine of equivalents to prove infringement of the " attached" limitation. Accordingly, the Court Grants in Part and Denies in Part Defendants' Motion.

I. BACKGROUND

A. Angioplasty Basics

The '119 Patent claims a balloon catheter with a non-deployable stent, which is a type of medical device used in angioplasty. Angioplasty is a term encompassing procedures for surgically repairing or clearing a blood vessel that has become occluded or blocked by plaque. This narrowing of the blood vessels is called stenosis; the blockages themselves are commonly called lesions.

One type of angioplasty procedure is percutaneous transluminal angioplasty (" PTA" ). In that procedure, a surgeon inserts a catheter tube through the skin (i.e., percutaneously) and into a blood vessel (i.e., transluminally). When the vessel leads to the heart, the procedure is a percutaneous transluminal coronary angioplasty (" PTCA" ). Both procedures begin the same way: the surgeon inserts a surgical sheath through the patient's skin and into a blood vessel, often at the top of the leg, in the femoral artery. The surgeon then inserts a guide wire through the sheath and threads it through the patient's body to the site of the lesion. The guide wire then acts as a " monorail track" which the surgeon may use to guide therapeutic devices into position in or near the lesion.

Different therapeutic devices have different effects. Most elementary and perhaps most familiar among these devices is the angioplasty balloon used in " POBA" procedures (" Plain Old Balloon Angioplasty" ). Angioplasty balloons are generally long and thin, and, because they are formed around a central catheter used to conduct the fluid that inflates the balloon, often called " balloon catheters." The basic principle of the angioplasty balloon is that, while in its deflated state, the surgeon may position the balloon inside a blockage, and then inflate the balloon to repair the blockage. Inflation causes the balloon walls to compress the plaque against the vessel wall, thus widening the vessel.

POBA angioplasties may present certain risks, however. Four are relevant here. The first is the risk of the balloon moving during inflation. When the balloon inflates, irregularities in the shape of the plaque, or other factors, may cause the balloon to slip and, thus, miss the surgeon's intended target. Second, the balloon may deform during inflation as it encounters the uneven surface of the plaque. Resistance from the plaque can result in portions of the balloon inflating more than others and this deformation, in turn, can cause the overinflated portion of the balloon to exert too much pressure on the vessel wall. Such pressure can lead to trauma, including coronary artery dissection, a serious complication wherein the arterial wall cracks. A third, and similar, risk arises when the balloon is longer than the lesion; in such cases, the portion of the

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balloon outside the lesion may inflate more than the portion within the lesion, an effect called " dog-boning." That effect, too, results in high pressure on the vessel wall and increased risk of trauma. Finally, the fourth potential risk relevant here is the problem of restenosis. Even where the angioplasty procedure successfully widens the treated vessel, trauma caused by the procedure may lead to the development of scar tissue and eventual re-narrowing of the vessel.

To decrease these risks, inventors have developed various angioplasty devices addressing the limitations of POBA. To counteract the problems of slippage and uneven pressure, " cutting" and " gripping" balloons may be used. Such balloons have metallic elements like blades or wires affixed to the exterior of the balloon along its working length. The metal elements focus the balloon's pressure more predictably and also reduce the risk of slippage.

With respect to the problem of restenosis, doctors may couple a balloon with a " stent." A stent is a small tube, commonly constructed of wire mesh. An uninflated balloon is placed inside the stent, and then the surgeon positions both stent and balloon together within the lesion. When the balloon inflates, the stent expands and is lodged within the vessel wall as a bolster. In the case of " deployable" stents, when the balloon deflates, the stent remains expanded and is left behind in the body when the surgeon retracts the balloon.

By contrast, non-deployable stents also exist. Such stents are removed from the body after expansion in the vessel. They have the ability to contract as the balloon deflates so that the stent may be retrieved without damage to the vessel walls. One way of fabricating such a stent is to construct it from a material having a shape memory, meaning that, when bent or otherwise reshaped, the material returns to its prior shape. With memory material, when a balloon is deflated, the stent, instead of remaining expanded, returns to its original shape, and may be removed along with the deflated balloon.

The manner of stent manufacture is pertinent to the case at bar. Stents, non-deployable and otherwise, may be manufactured by laser-cutting a " hypo tube." Generally speaking, a hypo tube is a medical-grade metal tube. They exist in a variety of sizes. Such tubes may be turned into stents by using a laser to cut out much of the metal, leaving behind only the mesh structure of the stent.

B. The '119 Patent Specification and Claims

The '119 Patent discloses an angioplasty balloon catheter with a specialized, non-deployable stent, denominated herein the " '119 Device." [3] The patent describes the background art, and the problem to be solved by the patent, in part as follows:

When a balloon used for percutaneous transluminal angioplasty (PTA) or percutaneous transluminal coronary angioplasty (PTCA) is inflated and forced into contact with the plaque, the balloon can have a tendency to move or slip longitudinally in relation to the lesion or the vessel wall being treated.
Cutting balloons (atherotomy) have recently shown clinical efficacy in preventing the reoccurrence of some types of restenosis . . . . As the cutting balloon is inflated, [microsurgical blades] move radially and open the occluded artery by incising and compressing the arterial plaque in a controlled manner. An additional advantage of the cutting balloon is

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that it maintains its position during inflation by using the metal blades on the external surface of the balloon to penetrate into the tissue and prevent the balloon from moving.
Accordingly, it is the principal objective of the present invention to provide a PTA or PTCA balloon that, like a cutting balloon, has a reduced potential of slippage when inflated in a vessel.

('119 Patent, col. 1:6-27.)

The patent specification describes a non-deployable stent that may be used in conjunction with a conventional balloon catheter, the latter encompassing " inner and outer members comprising a guide wire lumen and a balloon inflation lumen, respectively." [4] ('119 Patent, col. 1:63-67.) The " proximal" end of the catheter--that is, the end closest to the surgeon, as opposed to the " distal" or farther end--" has a luer hub for connecting an inflation means." [5] ( Id., col. 2:2-3.) The proximal and distal ends, or necks, of the balloon itself are cone-shaped when inflated. ( Id., col. 2:24-25.) The stent is " disposed," that is, placed, over the balloon catheter. ( Id., col. 2:26-41, 4:14-16.)

The patent specifies that the stent is made from a nickel-titanium alloy called Nitinol. ('119 Patent, col. 2:26-40.) Nitinol is a well-known memory material used in medical devices. ( Id., col. 2:48-49.) The patent specification describes a Nitinol structure comprised of a " laser cut hypo tube that expands upon inflation of the balloon, but collapses upon deflation of the balloon because of the super-elastic properties of the Nitinol material rather than remain expanded in the deployed condition, as would stents in general." ( Id., col. 2:36-40.) Specifically, the hypo tube is cut into a structure having three to twelve " struts . . . with a pattern of radial and longitudinal bends." ( Id., col. 2:43-45.) The struts are wires, the cross-sectional shape of which may be round, square, or triangular. ( Id.; id., col. 2:55-57.) The bends of the struts are " sinusoidal" in shape. ( Id., col. 2:50.)[6] The sinusoidal bends in the struts are sized to accommodate " both radial and longitudinal expansion of the [stent] in response to longitudinal and radial expansion of the balloon during inflation, so that the [stent] maintains the balloon in its intended position during inflation." ( Id., col. 2:27-32; see also id., col. 2:53-54.) The stent also may feature one or more U-shaped circumferential connectors which themselves accommodate balloon expansion. ( Id., col. 2:58-61, 3:35-49.)

Essentially, the '119 Patent describes a stent that expands as the balloon beneath it inflates and shrinks as the balloon beneath it deflates. The specification describes how the parts of the '119 Device fit together:

The distal end of the hypo tube is adhered to the distal neck of the balloon or the distal end of the catheter shaft, and the proximal end of the hypo tube is either attached to the proximal neck of the balloon or to the proximal end of the catheter shaft. The struts may be attached to the working region of the balloon

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to assist the hypo tube in staying with the balloon as it inflates and deflates, and an adhesive, such as a cyanoacrylate adhesive, may be used to tack the struts down onto balloon at various points.

('119 Patent, col. 2:61-3:3 (references to figures omitted).) The specification also contains mathematical formulas that specify that the " total length of the U-shaped connectors . . . must be greater than the circumference of the inflated balloon." ( Id., col. 3:11-13.)

The '119 Patent has nine claims. The latter eight all depend on the first. As a result, if Chocolate does not infringe claim 1, it does not infringe the '119 Patent. Claim 1 provides:

An angioplasty balloon catheter comprising:
a catheter shaft carrying an inflatable/deflatable balloon having a proximal end and a distal end; and
a non-deployable radially expansible stent comprising a hypo tube disposed over the balloon and comprising a proximal end; a distal end; and at least three longitudinally aligned, radially-spaced struts, wherein each strut extends from the proximal end to the distal end and prior to radial expansion has one or more bends that allow longitudinal expansion of the strut to accommodate radial expansion of the stent upon inflation of the balloon; wherein the distal end of the hypo tube is attached to the distal end of the catheter shaft and the proximal end of the tube is attached to the proximal end of the catheter shaft and the stent is made of a material having a memory so that the stent radially collapses and the struts longitudinally shorten upon deflation of the balloon.

('119 Patent, Claim 1 (disputed terms in bold italics).)

II. CLAIM CONSTRUCTION

A. Legal Framework

Defendants' motion for summary judgment of non-infringement of claim 1 of the '119 Patent requires the Court to undertake " a two-step analysis: (1) claim construction to determine the scope and meaning of the claims asserted to be infringed, and then (2) a determination of whether the properly construed claims encompass the accused device." Zelinski v. Brunswick Corp., 185 F.3d 1311, 1315 (Fed. Cir. 1999) (citing Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed. Cir. 1995) aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996)). Claim construction is a question of law for the Court rather than the finder of fact. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1304 (Fed. Cir. 1999). The Court turns now to that task.[7]

Words in a patent claim generally are given the " ordinary and customary meaning" that they would have to a person of ordinary skill in the art. Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc). " Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed

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term appears, but in the context of the entire patent, including the specification." Id. at 1313. " [T]he specification is always highly relevant to the claim construction analysis. Usually, it is dispositive; it is the single best guide to the meaning of a disputed term." Id. at 1315 (internal quotation marks omitted). " [T]he specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor's lexicography governs." Id. at 1316 (citation omitted). " In addition to consulting the specification, we have held that a court should also consider the patent's prosecution history, if it is in evidence." Id. at 1317 (internal quotation marks omitted). " [B]ecause the prosecution history represents an ongoing negotiation between the PTO and the applicant, rather than the final product of that negotiation, it often lacks the clarity of the specification and thus is less useful for claim construction purposes." Id. Extrinsic evidence may also " be useful to the court, but it is unlikely to result in a reliable interpretation of patent claim scope unless considered in the context of the intrinsic evidence." Id. at 1319.[8]

The claim construction dispute now at bar focuses on three terms that Defendants selected to demonstrate Chocolate's non-infringement of the '119 Patent. All three terms reside in the '119 Patent's first claim. The Court addresses them in turn.

B. Terms

1. " End"

Term

AngioScore's

Defendants'

Proposed

Proposed

Construction

Construction

a non-deployable radially expansible stent

" extends from

Ordinary and

comprising a hypo tube disposed over the

the end region

customary meaning

balloon and comprising a proximal end; a

of the stent

distal end; and at least three longitudinally

nearest the

aligned, radially-spaced struts, wherein

surgeon to the

each strut extends from the proximal end to

end region of

the distal end

the stent

farthest from

the surgeon"

The Court's Construction

" part of the device where the stent, catheter shaft, and balloon connect"

Claim 1 of the '119 Patent claims struts that extend from one end of the stent to the other end. The parties' dispute centers on whether the claim encompasses an end region or simply an end. AngioScore urges the former construction, basing its position primarily on language in the patent specification that describes the distinctive

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bends of the patented device as residing on the ends of the struts. Defendants, for their part, have abandoned previous proposed constructions and now submit that the term " end" may be given its ordinary and customary meaning.

As set forth below, the Court, based on its review of the claim language and patent specification, declines to adopt either parties' position, both of which are unclear and manifestly litigation-driven. While taking pains to avoid imputing to the '119 Patent a level of specificity not present in the claims themselves, the Court concludes that, in the disputed passage in Claim 1, someone of ordinary skill in the art would understand " ...


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