BSC USP 8,142,413
`Exhibit 1025
`
`Page 1 of 47
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
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`________________________________
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`VASCULAR SOLUTIONS, INC.,
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`Plaintiff,
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`v.
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`BOSTON SCIENTIFIC CORP.,
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`Defendant.
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`________________________________ )
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`Civil File No. 0:13-cv-01172-JRT-SER
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`DEFENDANT’S OPPOSITION TO PLAINTIFF’S
`MOTION FOR PRELIMINARY INJUNCTION
`
`

`

`Page 2 of 47
`
`TABLE OF CONTENTS
`
`Page
`
`DEFENDANT’S OPPOSITION TO PLAINTIFF’S MOTION FOR
`PRELIMINARY INJUNCTION ......................................................................................... 1
`
`INTRODUCTION ................................................................................................................ I
`
`BACKGROUND ................................................................................................................. 2
`
`A.
`
`B.
`
`C.
`
`The Adams Patent ......................................................................................... 3
`
`The VSI Patents ............................................................................................. 4
`
`VSI’s GuideLiner Catheters .......................................................................... 5
`
`ARGUMENT ....................................................................................................................... 8
`
`I.
`
`VSI CANNOT DEMONSTRATE A SUBSTANTIAL LIKELIHOOD OF
`SUCCESS ON ITS PATENT CLAIMS .................................................................. 9
`
`A.
`
`VSI Will Be Unable To Prove Infringement ................................................. 9
`
`1.
`
`Guidezilla Does Not Fall Within The Literal Scope Of The
`Claims ........................................................................................ 10
`
`a.
`
`b.
`
`Because Guidezilla’s metal “collar” indisputably
`contains a “lumen,” Guidezilla cannot infringe .................... 10
`
`Even if the “substantially rigid portion” of the device
`is limited to Guidezilla’s hypotube, the device still
`contains a “lumen” ................................................................ 11
`
`2.
`
`VSI’s Resort To The Doctrine Of Equivalents Is Foreclosed .......... 14
`
`B.
`
`The VSI Patents Are Invalid ....................................................................... 18
`
`1.
`
`The Adams Patent Anticipates The Claims Of The VSI
`Patents ....................................................................................... 19
`
`a.
`
`Adams discloses “a device for use with a standard
`guide catheter” ...................................................................... 19
`
`- i -
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`

`

`Page 3 of 47
`
`b.
`
`c.
`
`d.
`
`e.
`
`Adams discloses the claimed “flexible tip portion” .............. 20
`
`Adams discloses the claimed “substantially rigid
`portion” ................................................................................. 21
`
`Adams discloses the claimed distal and proximal
`extent of the device ............................................................... 23
`
`Adams teaches the claim elements disclosed in most of
`the dependent claims of the VSI patents ............................... 24
`
`2.
`
`The Claims Of The VSI Patents Are Obvious ................................. 25
`
`II.
`
`III.
`
`VSI CANNOT DEMONSTRATE IRREPARABLE HARM RESULTING
`FROM THE ALLEGED PATENT INFRINGEMENT ......................................... 29
`
`THE BALANCE OF HARMS WEIGHS AGAINST THE ISSUANCE OF
`A PRELIMINARY INJUNCTION ........................................................................ 33
`
`IV. A PRELIMINARY INJUNCTION WOULD HARM THE PUBLIC
`INTEREST ............................................................................................................. 35
`
`V.
`
`VSI’S CLAIMS FOR COPYRIGHT INFRINGEMENT DO NOT
`SUPPORT A PRELIMINARY INJUNCTION ..................................................... 37
`
`CONCLUSION ................................................................................................................. 39
`
`
`
`
`- ii -
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`

`

`Page 4 of 47
`
`
`
`TABLE OF AUTHORITIES
`
`CASES
`
`Page(s)
`
`Abbott Labs. v. Andrx Pharms., Inc.,
`452 F.3d 1331 (Fed. Cir. 2006)........................................................................................8, 9, 18
`
`Am. Cyanamid Co. v. U.S. Surgical Corp.,
`833 F. Supp. 92 (D. Conn. 1992) .............................................................................................31
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
`239 F.3d 1343 (Fed. Cir. 2001)........................................................................................8, 9, 18
`
`AquaTex Indus. v. Techniche Solutions,
`479 F.3d 1320 (Fed. Cir. 2007)................................................................................................17
`
`Apple Inc. v. Samsung Electronics Co.,
` 695 F.3d 1370 (Fed. Cir. 2012).................................................................................................38
`
`Atari Corp. v. Sega of Am., Inc.,
`869 F. Supp. 783 (N.D. Cal. 1994) ..........................................................................................30
`
`Aventis Pharma S.A. v. Hospira, Inc.,
`675 F.3d 1324 (Fed. Cir. 2012)................................................................................................13
`
`Bell & Howell Document Mgmt. Prods. Co. v. Altek Sys.,
`132 F.3d 701 (Fed. Cir. 1997)..................................................................................................34
`
`Brookhill-Wilk 1, LLC v. Intuitive Surgical, Inc.,
`334 F.3d 1294 (Fed. Cir. 2003)................................................................................................14
`
`Caldwell Mfg. Co. N. Am., LLC v. Amesbury Grp., Inc.,
`No. 11-CV-6183T, 2011 WL 3555833 (W.D.N.Y. Aug. 11, 2011) ..................................31, 33
`
`Canon, Inc. v. GCC Int’l Ltd.,
`263 Fed. Appx. 57 (Fed. Cir. 2008) .........................................................................................35
`
`Celsis In Vitro, Inc. v. CellzDirect, Inc.,
`664 F.3d 922 (Fed. Cir. 2012)..................................................................................................32
`
`City of Milwaukee v. Activated Sludge, Inc.,
`69 F.2d 577 (7th Cir. 1934) .....................................................................................................36
`
`Conoco, Inc. v. Energy & Envtl. Int’l, L.C.,
`460 F.3d 1349 (Fed. Cir. 2006)................................................................................................15
`
`Cordis Corp. v. Medtronic, Inc.,
`780 F.2d 991 (Fed. Cir. 1985)..................................................................................................30
`
`- iii -
`
`

`

`Page 5 of 47
`
`Datascope Corp. v. Kontron, Inc.,
`611 F. Supp. 889 (D. Mass. 1985), aff’d. 786 F.2d 398 (Fed. Cir. 1986)................................36
`
`Decade Indus. v. Wood Tech., Inc.,
`100 F. Supp. 2d 979 (D. Minn. 2000) ......................................................................................35
`
`Douglas Dynamics, LLC v. Buyers Prods. Co.,
`Nos. 2011-1291 ........................................................................................................................33
`
`Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co.,
`535 U.S. 722 (2002) .................................................................................................................15
`
`Glaxo Inc. v. Novopharm Ltd.,
`52 F.3d 1043 (Fed. Cir. 1995)..................................................................................................19
`
`Glaxo Wellcome, Inc. v. Impax Labs., Inc.,
`356 F.3d 1348 (Fed. Cir. 2004)................................................................................................16
`
`Graceway Pharms., LLC v. Perrigo Co.,
`722 F. Supp. 2d 566 (D.N.J. 2010) ..........................................................................................31
`
`Howes v. Med. Components, Inc.,
`814 F.2d 638 (Fed. Cir. 1987)..................................................................................................13
`
`Hybritech Inc. v. Abbott Labs.,
`849 F.2d 1446 (Fed. Cir. 1988)................................................................................................37
`
`Illinois Tool Works, Inc. v. Grip-Pak, Inc.,
`906 F.2d 679 (Fed. Cir. 1990)..................................................................................................33
`
`Intel Corp. v. ULSI Sys. Tech. Inc.,
`995 F.2d 1566 (Fed. Cir. 1993)..................................................................................................8
`
`Kimberly-Clark Worldwide, Inc. v. Tyco Healthcare Grp. L.P.,
`635 F. Supp. 2d 870 (E.D. Wis. 2009) .....................................................................................32
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ...........................................................................................................25, 27
`
`Laryngeal Mask Co. v. Ambu A/S,
`618 F.3d 1367 (Fed. Cir. 2010)................................................................................................13
`
`Merck & Co. v. Teva Pharms. USA, Inc.,
`395 F.3d 1364 (Fed. Cir. 2005)................................................................................................13
`
`Mirror Worlds LLC v. Apple, Inc.,
`692 F.3d 1351 (Fed. Cir. 2012)................................................................................................17
`
`- iv -
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`

`

`Page 6 of 47
`
`Nat’l Steel Car, Ltd. v. Canadian Pac. Ry., Ltd.,
`357 F.3d 1319 (Fed. Cir. 2004)..................................................................................................8
`
`Novartis Corp. v. Teva Pharms. USA, Inc.,
`Nos. 04-4473 & 06-1130, 2007 WL1695689, at *3 (D.N.J. June 11, 2007) .............................9
`
`Nutrition 21 v. United States,
`930 F.2d 867 (Fed. Cir. 1991)..................................................................................................31
`
`Pergo, Inc. v. Faus Group, Inc.,
`401 F. Supp. 2d 515 (E.D.N.C. 2005)......................................................................................33
`
`Precision Automation, Inc. v. Tech. Servs., Inc.,
`No. 07-CV-707-AS, 2007 WL 4480739 (D. Or. Dec. 14, 2007) .............................................30
`
`Ruiz v. A.B. Chance Co.,
`357 F.3d 1270 (Fed.Cir.2004)..................................................................................................27
`
`Sanofi-Synthelabo v. Apotex, Inc.,
`470 F.3d 1368 (Fed. Cir. 2006)................................................................................................35
`
`Sciele Pharma, Inc. v. Lupin Ltd.,
`684 F.3d 1253 (Fed. Cir. 2012)................................................................................................18
`
`SciMed Life Sys. v. Advanced Cardiovascular Sys.,
`242 F.3d 1337 (Fed. Cir. 2001)................................................................................................16
`
`Scripps Clinic & Research Found. v. Genentech, Inc.,
`666 F. Supp. 1379 (N.D. Cal. 1987), aff’d, 927 F.2d 1565 (Fed. Cir. 1991) ...........................36
`
`Thorner v. Sony Computer Entm’t Am. L.L.C.,
`669 F.3d 1362 (Fed. Cir. 2012)..........................................................................................13, 14
`
`Tseng v. Home Depot USA, Inc.,
`No. C05-0908, 2006 WL 521723 (W.D. Wash. March 2, 2006).............................................30
`
`Visto Corp. v. Sproquit Tech., Inc.,
`413 F. Supp. 2d 1073 (N.D. Cal. 2006) ...................................................................................30
`
`Vitamin Technologists, Inc. v. Wis. Alumni Research Found.,
`146 F.2d 941 (9th Cir. 1945) ...................................................................................................36
`
`STATUTES
`
`35 U.S.C. § 102 ................................................................................................................................1
`
`35 U.S.C. § 103 ................................................................................................................................1
`
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`Page 7 of 47
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`OTHER AUTHORITIES
`
`McGraw-Hill Dictionary Of Scientific And Technical Terms (6th ed. 2006) ..............................12
`
`Mosby’s Pocket Dictionary Of Medicine, Nursing & Health Professions (5th ed. 2006).............12
`
`R. Cammack, Oxford Dictionary Of Biochemistry And Molecular Biology (2nd ed. 2006) ........12
`
`Stedman’s Medical Dictionary (28th ed. 2006) .............................................................................12
`
`W.G. Hale, V. A. Saunders & J.P. Margham, Collins Web-Linked Dictionary of Biology
`(Rev. ed. 2006) ........................................................................................................................12
`
`
`
`
`
`
`
`- vi -
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`

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`Page 8 of 47
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`INTRODUCTION
`
`To be entitled to the extraordinary remedy of preliminary injunctive relief against
`
`defendant Boston Scientific Corporation (“BSC”), plaintiff Vascular Solutions, Inc.
`
`(“VSI”) must show that the accused product, BSC’s Guidezilla guide catheter extension,
`
`is likely to be found to infringe one or more valid claims of the VSI patents.1 VSI cannot
`
`do so for two reasons. First, it cannot prove infringement. Every claim of the VSI
`
`patents requires a “substantially rigid portion” “without a lumen.” VSI’s principal has
`
`admitted that the Guidezilla’s “substantially rigid portion” contains one “lumen,” and
`
`based on the ordinary meaning of that term (which VSI artificially limits in its briefing),
`
`it actually contains another “lumen” as well. Second, the asserted claims of the VSI
`
`patents are invalid. BSC’s own patent, U.S. Patent No. 5,527,292 (the “Adams patent”)
`
`(Exhibit 1)2—which issued more than a decade before the VSI patents but which was
`
`undisclosed during their prosecution—invalidates all of the claims of the VSI patents.3
`
`At a minimum, the Adams patent raises substantial questions of validity that preclude a
`
`
`1 VSI asserts U.S. Patent Nos. 8,048,032 (the “ ‘032 patent”), 8,142,413 B2 (the “ ‘413
`patent”), and 8,292,850 B2 (the “ ‘850 patent”) (collectively, the “VSI patents”) (Pl.
`Mem. at 19). The VSI patents are attached as Exhibits 2 through 4, respectively, of the
`Declaration of Howard Root in Support of Plaintiff’s Motion for Preliminary Injunction
`(“Root Decl.”).
`2 Unless otherwise indicated, “Exhibit __” refers to exhibits to the Declaration of Sarah
`Stensland, submitted herewith.
`3 As shown below, the Adams patent anticipates all of the independent claims of the
`VSI patents, and virtually all of the dependent claims, invalidating them under 35 U.S.C.
`§ 102. In addition, the Adams patent invalidates all of the asserted claims under 35
`U.S.C. § 103 (insofar as all claims would have been obvious at the time of the first VSI
`patent application in view of Adams alone or in combination with the knowledge of a
`person of ordinary skill in the art or other relevant prior art).
`
`- 1 -
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`Page 9 of 47
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`finding that VSI has met its burden of showing likelihood of success at trial. Indeed, if
`
`the present briefing demonstrates anything, it is that VSI itself has infringed BSC’s
`
`Adams patent.4
`
`Nor can VSI demonstrate irreparable harm, as is also required before a preliminary
`
`injunction can issue. VSI concedes that the harm it is most likely to suffer as a result of
`
`the denial of an injunction—the loss of GuideLiner sales—is compensable through
`
`money damages. The other harms cited by VSI are speculative and unsupported by the
`
`record. The remaining preliminary injunction factors—including the public interest in
`
`the continued availability of BSC’s Guidezilla, which at least some physicians consider a
`
`superior medical device—also weigh against an injunction. Accordingly, the Court
`
`should deny VSI’s motion for a preliminary injunction.
`
`BACKGROUND
`
`VSI claims that, in 2006, it “pioneered an entirely new concept of mother-and-
`
`child guide extension with monorail delivery.” (Plaintiff’s Memorandum in Support of
`
`Motion for Preliminary Injunction (“Pl. Mem.”) at 9.) Explaining the essential invention
`
`disclosed in the VSI patents, VSI’s principal (and alleged lead inventor), Howard Root
`
`testified:
`
`Q. … Can you describe in your own words what is the inventive feature
`of the VSI patents?
`
`* * *
`
`
`4 BSC intends to plead counterclaims asserting that VSI’s GuideLiner catheter infringes
`multiple claims of the Adams patent.
`
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`Page 10 of 47
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`So in very general terms, what we’ve invented is guide extension
`A.
`using rapid exchange convenience or delivery.
`
`(Exhibit 2 [Root Dep.] at 121 (emphasis added).) Contrary to the present claims of VSI
`
`and Mr. Root, VSI did not invent a “mother-and-child guide extension with monorail
`
`delivery” or a “guide extension using rapid exchange convenience or delivery.” In
`
`actuality, these concepts were developed twelve years earlier by Daniel Adams and Scott
`
`Thome.
`
`A.
`
`The Adams Patent
`
`The Adams patent issued in June 1996 from an application filed in September
`
`1994. (Exhibit 1.) The patent was assigned to SciMed Life Systems, Inc. (id.), which
`
`was acquired by BSC in November 1994. The Adams patent discloses, among other
`
`things:
`
`An intravascular device having an elongated flexible tube sized for
`insertion into a coronary vessel beyond a distal end of a guide catheter. In
`use, the flexible tube has its proximal end within a guide catheter and has
`its distal end extending to a treatment site in a coronary artery. The device
`also including a push rod attached to a proximal end of the flexible tube to
`facilitate placement of the flexible tube within the coronary artery requiring
`treatment…. [T]he intravascular device is used as a guiding means for
`placement of an angioplasty device, such as a guide wire or a balloon
`catheter.
`
`(Id., abstract.) One of the purposes of the Adams device is “to maintain the position of
`
`the guide catheter 12 at the coronary ostium during operation….” (Id., col. 9, ll. 12-15.)
`
`The Adams patent clearly discloses a guide catheter extension: “The invention is
`
`directed to the structure and use of a distal extension (intravascular device) for a guide
`
`catheter.” (Id., col 4, ll. 35-38.) The guide catheter extension of Adams also incorporates
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`Page 11 of 47
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`“rapid exchange” design. As explained in the declaration of Howard Root, the CEO of
`
`plaintiff VSI:
`
`An alternative type of catheter used in coronary catheterization procedures
`is referred to as monorail, rapid exchange, single operator, or sliding rail.
`All of these names refer to the same type of catheter construction with a
`relative short (generally 20cm - 40cm) lumen used to deliver the catheter
`over a guidewire, attached to a longer and stiffer push rod….
`
`(Root Decl. ¶ 20.) The Adams patent discloses the same configuration. Specifically, it
`
`teaches guide catheter extension with a catheter portion—i.e., a flexible tube—that is:
`
`
`
`
`
`
`
`10 inches or approximately 25cm long (Exhibit 1, [Adams patent]
`col. 15, ll. 49-50 (“The flexible tube 255 is approximately 6.0 to
`12.0 inches in length, and preferably 9.5 to 10.0 inches in length”)
`(emphasis added);
`
`delivered over a guide wire (id., col. 16, ll. 18-28 (“the flexible tube
`is advanced in cooperation with another coronary treatment
`device…. Examples of a treatment device which could be used to
`support the flexible tube to provide pushability for advancement
`include … a guide wire”) (emphasis added); and
`
`attached to a longer and stiffer push rod. (Id., col. 15, ll. 50-52
`(“The push rod is approximately 40.0 to 45.0 inches in length”), col.
`6, ll. 1-2 (“push rod is attached to a proximal end of the elongated
`flexible tube …”).
`
`Over ten years before VSI’s supposed “invention” the Adams patent disclosed a
`
`“monorail” guide catheter extension using rapid exchange delivery.
`
`B.
`
`The VSI Patents
`
`Like the Adams patent, the VSI patents purport to disclose a flexible tube attached
`
`to a shaft or push rod. (E.g., ‘032 patent, claim 1 (“a flexible tip portion defining a
`
`tubular structure,” “a substantially rigid portion proximal of and operably connected to,
`
`and more rigid along a longitudinal axis than, the flexible tip portion”).) Like the Adams
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`Page 12 of 47
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`patent, one of the purposes of the purported invention of the VSI patents is to “assist[] in
`
`resisting both the axial forces and the shearing forces that tend to dislodge a guide
`
`catheter from the ostium of a branch artery.” (‘032 patent, col. 4, l. 66-col. 5, l. 3.)
`
`As described below (see Argument § I.B), the Adams patent—which was never
`
`considered by the Examiner during the prosecution of the VSI patents—anticipates every
`
`independent claim, and most of the asserted dependent claims, of the VSI patents. In
`
`light of the Adams patent, in combination with the knowledge of persons of ordinary skill
`
`in the art of catheter design and/or other prior art that was not disclosed to the examiner,
`
`every claim of the VSI patents is obvious. At a minimum, there is a substantial question
`
`as to the validity of the claims of the VSI patents.
`
`C.
`
`VSI’s GuideLiner Catheters
`
`Beginning in 2009, VSI manufactured and sold the GuideLiner catheter; and
`
`beginning in 2012, VSI manufactured and sold a second version of this catheter, the
`
`GuideLiner V2, which is similar to the original version in all material respects. (Root
`
`Decl. ¶¶ 12, 31.) According to Mr. Root, “[b]oth the GuideLiner V1 and the GuideLiner
`
`V2 are embodiments of the coaxial guide catheter described and claimed in the VSI
`
`patents.” (Id. ¶ 36.)
`
`From 2009 through the expiration of the Adams patent in June 2013, VSI’s
`
`GuideLiner catheter infringed multiple claims of BSC’s Adams patent. The chart below
`
`shows how the GuideLiner meets every element of one exemplary claim (claim 25) of the
`
`Adams patent:
`
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`Page 13 of 47
`
`Adams Patent Claim 25
`
` 25. For use in combination with
`a guide catheter having a
`proximal end, a distal end, and a
`central lumen,
`
`an intravascular device
`comprising:
`
`
`a relatively flexible tube …
`
`
`
`
`
`
`GuideLiner
`
`“GuideLiner catheters are intended to be used in
`conjunction with guide catheters …” (Exhibit 3
`[GuideLiner V2 IFU])
`
`Q. ... [I]n the context of a guide catheter, does it have
`a distal end and a proximal end?
`... A. We refer to it that way. And distal means
`furthest away, and proximal means closest to. So if a
`physician is using a guide catheter, the end that
`would be in their hands or attached to the hemostatic
`valve, I would consider the proximal end. And the
`one that’s in the ostium of the artery is the distal
`end….
`(Exhibit 2 [Root Dep.] at 35.)
`
` Q. ... With respect to a guide catheter, does —
`well, first of all, does it have a lumen?
` A. Yes. Guide catheter has a lumen.
`(Exhibit 2 [Root Dep.] at 37.)
`
` Q. And the -- and how about the guide catheter and
`GuideLiner itself, would they be intravascular?
` A. Yes. GuideLiner, guide catheter are
`intravascular — are delivered intravascular, which
`one of my — I think the way you’re using it means
`inside the vessel.
`(Exhibit 2 [Root Dep.] at 32)
`
`“The distal end … of the GuideLiner is a relatively
`flexible tube with a lumen” (Pl. Mem. at 6)
`
`
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`

`Page 14 of 47
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`having a proximal end, a distal
`end, an outer diameter and an
`internal lumen, wherein the outer
`diameter is sized for insertion
`through the central lumen of the
`guide catheter…
`
`
`so that the distal end of the tube
`may be positioned beyond the
`distal end of the guide catheter to
`extend the flexible tube to the
`treatment site; and
`“a push rod …”
`
`eccentrically coupled to the tube
`and
`
`
`“The GuideLiner catheter is delivered through a
`guide catheter resulting in an inner diameter …
`approximately 1 French smaller than the guide
`catheter. The GuideLiner catheter has a proximal tab
`which indicates guide catheter compatibility and the
`resulting GuideLiner catheter inner diameter”
`(Exhibit 3 [GuideLiner V2 IFU])
`
`“advance the GuideLiner catheter up to a maximum
`of 15cm beyond the distal tip of the guide catheter
`and into the desired location within the vessel”
`(Exhibit 3 [GuideLiner V2 IFU])
`
`“The collar is then connected to a substantially rigid
`push rod that extends for the remainder of the length
`of the GuideLiner catheter” (Root Decl. ¶ 24)
`
`
`
`
`(Root Decl. ¶ 23)
`
` A. ... So if you want to think about it in general
`terms, it’s the tongue of the tube where the push rod
`is attached.
` Q. It’s certainly not at the center of the tube. It’s
`not at the center of the lumen defined by the tube?
` A. I don’t — there is no center. I mean, there’s an
`open space in the middle.
` Q. Right.
` A. You couldn’t attach anything to the open space
`in the middle.
`(Exhibit 2 [Root Dep.] at 108-09.)
`
`
`
`
`
`
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`

`Page 15 of 47
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`extending proximally therefrom
`for slidably positioning the tube.
`
`
` A. The GuideLiner slides within the guide catheter,
`yes.
` Q. And so the push rod helps place the guide
`extension within the coronary artery that the
`physician is trying to treat. Correct?
` A. Yes.
`(Exhibit 2 [Root Dep.] at 77.)
`
`
`
`
`In addition to claim 25, VSI’s GuideLiner catheters have also infringed claims 12,
`
`17, 18, 19, 20, 26, 31, 32, 33, 34, 35, 37, 38, 39, 40 and 41 of the Adams patent.
`
`ARGUMENT
`
`A preliminary injunction is an extraordinary remedy that is not to be routinely
`
`granted. Intel Corp. v. ULSI Sys. Tech. Inc., 995 F.2d 1566, 1568 (Fed. Cir. 1993). As
`
`the moving party, VSI must show: (1) a reasonable likelihood of success on the merits;
`
`(2) irreparable harm if the injunction is not granted; (3) a balance of hardships tipping in
`
`its favor; and (4) the injunction’s favorable impact on the public interest. See
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed. Cir. 2001);
`
`Abbott Labs. v. Andrx Pharms., Inc., 452 F.3d 1331, 1334 (Fed. Cir. 2006). With respect
`
`to the first two of these factors, the inquiry is not a balancing test; that is, the strength of
`
`one showing cannot compensate for any question as to the strength of the other. A
`
`preliminary injunction should not issue unless the movant demonstrates both a likelihood
`
`of success and irreparable harm. See Amazon.com, 239 F.3d at 1350 (“Our case law and
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`logic both require that a movant cannot be granted a preliminary injunction unless it
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`establishes both of the first two factors, i.e., likelihood of success on the merits and
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`irreparable harm”) (emphasis in original); Nat’l Steel Car, Ltd. v. Canadian Pac. Ry.,
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`Page 16 of 47
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`Ltd., 357 F.3d 1319, 1325 (Fed. Cir. 2004); Novartis Corp. v. Teva Pharms. USA, Inc.,
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`Nos. 04-4473 & 06-1130, 2007 WL1695689, at *3 (D.N.J. June 11, 2007).
`
`I.
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`VSI CANNOT DEMONSTRATE A SUBSTANTIAL LIKELIHOOD
`OF SUCCESS ON ITS PATENT CLAIMS
`
`In the patent context, if the defendant raises a “substantial question” as to either
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`infringement or validity—i.e., if the patentee cannot demonstrate that the defendant’s
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`defenses “lack substantial merit”—then the patentee has not established a likelihood of
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`success. Amazon.com, 239 F.3d at 1350-51 (“If [the defendant] raises a substantial
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`question concerning either infringement or validity, i.e., asserts an infringement or
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`invalidity defense that the patentee cannot prove ‘lacks substantial merit,’ the preliminary
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`injunction should not issue”); Abbott Labs., 452 F.3d at 1335. As shown herein, because
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`BSC raises substantial questions as to both infringement and validity, VSI cannot meet its
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`burden of proving a likelihood of success on the merits, and its motion for a preliminary
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`injunction should be denied.
`
`A.
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`VSI Will Be Unable To Prove Infringement
`
`Prior to allowance, each independent claim of the ‘032 patent was amended by the
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`Examiner to require that the “substantially rigid portion” of the claimed device “define a
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`rail structure without a lumen.” (Exhibit 4.) Eager to obtain allowance after multiple
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`rejections, VSI did not object to the amendment or seek to alter it; thus, the “without a
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`lumen” limitation appears in both independent claims of the ‘032 patent. (‘032 patent,
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`claims 1, 11.) The same limitation was included in each independent claim of the ‘413
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`patent and ‘850 patent. (‘413 patent, claim 1; ‘850 patent, claims 1, 12.) BSC’s
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`Page 17 of 47
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`Guidezilla guide catheter extension does not satisfy this limitation either literally or under
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`the doctrine of equivalents.
`
`1.
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`Guidezilla Does Not Fall Within The Literal Scope Of The
`Claims
`
`a.
`
`Because Guidezilla’s metal “collar” indisputably
`contains a “lumen,” Guidezilla cannot infringe
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`The “without a lumen” limitation, which was essential to the patentability of the
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`claims, is also fatal to VSI’s assertions of infringement. As VSI admits, the Guidezilla’s
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`accused “flexible tip” is joined proximally to a tubular metal “collar.” (Pl. Mem. at 21
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`(“The Guidezilla connects the flexible tip to the substantially rigid portion with a
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`transitional collar”). The metal collar, which is “proximal of and operably connected to,
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`and more rigid long a longitudinal axis than, the flexible tip portion” of the device,
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`possesses a “lumen” under any conceivable definition of that term.
`
`Indeed, VSI admitted as much in the recent deposition of its principal, Howard
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`Root. According to Mr. Root, because it is made of metal, the collar of the GuideLiner
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`V1 is part of the device’s “substantially rigid portion”:
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`In the GuideLiner, is the collar part of the flexible tube or flexible tip
`Q.
`portion, or is it part of the substantially rigid portion, or is it neither. Do
`you have an understanding?
`
`A. As I understand it, it—the collar, the metal collar on the GuideLiner
`V1 is not part of the flexible tip portion to the extent that it’s—it’s not
`flexible. It is part of the substantially rigid portion, which really consists
`of the push rod as well as the metal collar.
`
`(Exhibit 2 [Root Dep.] at 94 (emphasis added).) Moreover, Mr. Root admitted that this
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`collar possesses a “lumen”:
`
`Q.
`
`Correct. There’s a fully cylindrical portion of the collar. Correct?
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`Page 18 of 47
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`There is—yeah, in this drawing, there is a fully cylindrical portion
`A.
`of the collar that is open on the middle that allows the passage of devices.
`
`Q.
`
`A.
`
`Okay.
`
`So there is a lumen in the distal section of the collar.
`
`(Exhibit 2 [Root Dep.] at 95 (emphasis added).) Mr. Root also acknowledged that, like
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`the GuideLiner V1, Guidezilla has a metal collar through which devices, such as stents,
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`are delivered:
`
`A. Well, stents when they’re delivered through the Guidezilla or the
`GuideLiner have to go through the metal collar and get into the full
`round section and the distal section…. And I point out here that Guidezilla
`has a metal collar like our original V1.
`
`(id. at 165 (emphasis added).) Accordingly, there can be no dispute that Guidezilla’s
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`collar, like the Guideliner’s, possesses a “lumen.” Because this portion of the alleged
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`“substantially rigid portion” of the accused device indisputably contains a lumen, VSI
`
`cannot claim that the “substantially rigid portion” of the claimed device “define[s] a rail
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`structure without a lumen.” VSI therefore cannot prove infringement.
`
`b.
`
`Even if the “substantially rigid portion” of the
`device is limited to Guidezilla’s hypotube, the
`device still contains a “lumen”
`
`Ignoring the “collar” portion of the alleged “substantially rigid portion” of the
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`accused Guidezilla device, VSI focuses on the hypotube that runs from the proximal end
`
`of the device up to the collar. As VSI notes, a hypotube is a stainless steel tube used, for
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`example, in hypodermic needles. (Pl. Mem. at 25.) VSI admits that this tube contains
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`“an open space in the middle” or a “cavity.” (Id.) VSI argues nonetheless that, because it
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`is sealed at one end during the manufacturing process, the hypotube lacks a “lumen.” (Pl.
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`Page 19 of 47
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`Mem. at 26-27.) To frame this argument, VSI insists that a “lumen” is “the interior of a
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`tubular structure, open at both ends to allow the passage of medical devices.” (Pl. Mem.
`
`at 22) In other words, according to VSI, a lumen cannot be closed at either end.
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`VSI’s self-serving and overly narrow definition of “lumen” is incorrect. Medical
`
`an