BSC USP 8,048,032
`Exhibit 1033
`
`Page 1 of 78
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`Case: 14-1185 CASE PARTICIPANTS ONLY Document: 32 Page: 1 Filed: 01/29/2014Case: 14-1185 Document: 34 Page: 1 Filed: 01/29/2014
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`IN THE UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`
`
`
`
`
`No. 2014-1185
`
`
`
`
`
`
`
`VASCULAR SOLUTIONS, INC.,
`
`Plaintiff-Appellee,
`
`v.
`
`BOSTON SCIENTIFIC CORPORATION,
`
`
`
`
`
`Defendant-Appellant.
`
`
`On Appeal from the United States District Court
`For the District of Minnesota in Case No. 13-cv-01172-JRT-SER
`Judge John R. Tunheim
`
`
`
`
`
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`
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`
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`CORRECTED BRIEF OF APPELLEE VASCULAR SOLUTIONS, INC.
`
`NONCONFIDENTIAL VERSION
`
`
`
`
`
`
`
`Dorsey & Whitney LLP
`J. Thomas Vitt
`Heather D. Redmond
`Suite 1500, 50 South Sixth Street
`Minneapolis, MN 55402-1498
`Telephone: (612) 340-2600
`
`Attorneys for Plaintiff-Appellee
`Vascular Solutions, Inc.
`
`
`
`
`
`January 29, 2014
`
`
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`CERTIFICATE OF INTEREST
`
`Counsel for Plaintiff-Appellee Vascular Solutions, Inc. certifies the
`
`following:
`
`1.
`
`The full name of every party or amicus represented by me is:
`
`Vascular Solutions, Inc.
`
`The name of the real party in interest (if the party named in the
`2.
`caption is not the real party in interest) represented by me is:
`
`Vascular Solutions, Inc.
`
`All parent corporations and any publicly held companies that own 10
`3.
`percent or more of the stock of the party of amicus curiae represented by me are:
`
`Vascular Solutions, Inc. is a publicly traded corporation; it has
`no parent corporation; and no publicly held company owns
`more than 10% of its stock.
`
`The names of all law firms and the partners or associates that
`4.
`appeared for the party or amicus now represented by me in the trial court or agency
`or are expected to appear in this court are:
`
`J. Thomas Vitt
`Heather D. Redmond
`Shannon L. Bjorklund
`Forrest Tahdooahnippah
`
`Dorsey & Whitney LLP
`50 South Sixth Street, Suite 1500
`Minneapolis, MN 55402-1498
`Telephone: (612) 340-2600
`Facsimile: (612) 340-2868
`
`
`
`
`
`
`
`

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`Dated: January 29, 2014
`
`Respectfully submitted,
`
`DORSEY & WHITNEY LLP
`
`
`By /s/ Heather D. Redmond
`J. Thomas Vitt
`Heather D. Redmond
`50 South Sixth Street, Suite 1500
`Minneapolis, MN 55402-1498
`Telephone: (612) 340-2600
`
`Attorneys for Plaintiff-Appellee Vascular
`Solutions, Inc.
`
`
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`Page 4 of 78
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`
`
`TABLE OF CONTENTS
`
`TABLE OF AUTHORITIES .................................................................................... iv
`
`STATEMENT OF RELATED CASES ................................................................. viii
`
`STATEMENT OF THE ISSUES............................................................................... 1
`
`STATEMENT OF THE CASE .................................................................................. 2
`
`I.
`II.
`
`V.
`
`THE PARTIES ........................................................................................... 2
`VSI’S INVENTION SOLVED A LONG-STANDING PROBLEM
`IN INTERVENTIONAL CARDIOLOGY ................................................ 3
`Cardiac Catheterization Procedures And Guide Catheter
`A.
`Limitations ........................................................................................ 3
`Prior Attempts To Solve Guide Catheter Limitations ....................... 4
`B.
`Over-The-Wire And Monorail Systems ............................................ 5
`C.
`D. VSI’s “Game-Changing” GuideLiner Catheter ................................ 5
`GuideLiner’s Flexible Portion ................................................ 6
`1.
`2.
`GuideLiner’s Substantially Rigid Portion .............................. 8
`3.
`GuideLiner’s Transition Collar ............................................... 9
`VSI’S GuideLiner Is Clinically And Commercially
`Successful ........................................................................................ 10
`III. VSI’S GUIDELINER PATENTS ............................................................ 11
`IV. BSC COPIES GUIDELINER AND INFRINGES VSI’S
`PATENTS ................................................................................................. 12
`BSC’S INFRINGEMENT WAS CAUSING SUBSTANTIAL
`IRREPARABLE HARM .......................................................................... 16
`VI. BSC’S DEFENSES .................................................................................. 17
`BSC’s Noninfringement Defenses .................................................. 17
`A.
`B.
`BSC’s Invalidity Defense ................................................................ 17
`The Adams Patent ................................................................. 18
`1.
`2.
`Verbeek, Steinke, and Alt ..................................................... 21
`
`E.
`
`i
`
`

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`
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`VII. BSC HAD A FAIR OPPORTUNITY TO PRESENT ITS
`DEFENSES .............................................................................................. 23
`VIII. THE PRELIMINARY INJUNCTION ORDER ...................................... 25
`
`SUMMARY OF ARGUMENT ............................................................................... 26
`
`ARGUMENT ........................................................................................................... 29
`
`I.
`II.
`
`B.
`
`C.
`
`STANDARD OF REVIEW ...................................................................... 30
`THERE WAS NO LEGAL ERROR IN THE DISTRICT
`COURT’S CLAIM CONSTRUCTION, AND VSI IS LIKELY TO
`ESTABLISH INFRINGEMENT OF MULTIPLE CLAIMS .................. 31
`“Without a Lumen” Applies To The Rail Structure,
`1.
`Not The Collar Or Entire Substantially Rigid Portion ......... 32
`A “Lumen” Requires A Passageway For Medical Devices ............ 35
`The Intrinsic Evidence Supports The District Court’s
`1.
`Construction .......................................................................... 35
`The Extrinsic Evidence Also Supports The District
`Court’s Construction ............................................................. 39
`VSI Is Likely To Establish BSC’s Infringement Of Multiple
`Claims .............................................................................................. 43
`III. THE DISTRICT COURT CORRECTLY FOUND THAT BSC
`WAS NOT LIKELY TO ESTABLISH THAT THE ASSERTED
`CLAIMS WERE OBVIOUS .................................................................... 44
`Standard Of Review ........................................................................ 44
`A.
`B.
`The District Court Correctly Found That VSI Was Likely To
`Overcome BSC’s Obviousness Defense Based On
`Adams/Verbeek/Alt/Stein ............................................................... 45
`Verbeek/Steinke/Alt Do Not Disclose All Of The
`1.
`Missing Limitations Of The Asserted Claims ...................... 47
`BSC Presented No Evidence Establishing A
`Motivation To Combine Adams With
`Verbeek/Steinke/Alt .............................................................. 50
`The District Court Correctly Found That Secondary
`Considerations Weigh In Favor Of Finding The
`
`2.
`
`2.
`
`3.
`
`ii
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`

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`
`
`C.
`
`2.
`
`Asserted Claims Were Not Obvious ..................................... 53
`BSC’s Late Addition Of Klein Does Not Render The
`Asserted Claims Obvious ................................................................ 55
`BSC Waived Any Argument Relying On Klein, And
`1.
`Klein Should Be Stricken From The Record On
`Appeal ................................................................................... 55
`Klein Is Missing Key Elements Of The Asserted
`Claims And There Is No Evidence Establishing A
`Motivation To Combine........................................................ 58
`IV. THE DISTRICT COURT CORRECTLY FOUND THAT VSI
`HAD ESTABLISHED IRREPARABLE HARM CAUSED BY
`BSC’S INFRINGEMENT ........................................................................ 61
`THE COURT SHOULD STRIKE EVIDENCE THAT IS NOT
`PART OF THE RECORD ON APPEAL ................................................. 63
`
`V.
`
`CONCLUSION ........................................................................................................ 65
`
`
`
`**CONFIDENTIAL MATERIAL HAS BEEN REDACTED PURSUANT TO A
`PROTECTIVE ORDER ISSUED BY THE DISTRICT COURT. MATERIAL ON
`p. 43 IS REDACTED TO PROTECT TECHNICAL DESIGN INFORMATION
`DESIGNATED CONFIDENTIAL BY BSC. MATERIAL ON p. 55 HAS BEEN
`REDACTED TO PROTECT COMPETITIVE INFORMATION DESIGNATED
`CONFIDENTIAL BY BSC**
`
`
`iii
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`
`
`
`CASES
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`3M Innovative Props. Co. v. Avery Dennison Corp.,
`350 F.3d 1365 (Fed. Cir. 2003) .......................................................................... 60
`
`ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc.,
`694 F.3d 1312 (Fed. Cir. 2012) .......................................................................... 51
`
`Am. Standard, Inc. v. Pfizer, Inc.,
`828 F.2d 734 (Fed. Cir. 1987) ............................................................................ 57
`
`Apple Inc. v. Samsung Elecs. Co.,
`695 F.3d 1370 (Fed. Cir. 2012) ........................................................ 29, 30, 61, 62
`
`AstraZeneca LP v. Apotex, Inc.,
`633 F.3d 1042 (Fed. Cir. 2010) .................................................................... 30, 37
`
`Bell Atl. Network Servs., Inc. v. Covad Commc’ns Grp., Inc.,
`262 F.3d 1258 (Fed. Cir. 2001) .......................................................................... 41
`
`Bluebonnet Sav. Bank, F.S.B. v. United States,
`466 F.3d 1349 (Fed. Cir. 2006) .......................................................................... 56
`
`Breathablebaby, LLC v. Crown Crafts, Inc.,
`2013 WL 5230724 (D. Minn. Sept. 17, 2013) .................................................... 56
`
`Celsis In Vitro, Inc. v. CellzDirect, Inc.,
`664 F.3d 922 (Fed. Cir. 2012) ............................................................................ 45
`
`Crocs, Inc. v. Int’l Trade Comm’n,
`598 F.3d 1294 (Fed. Cir. 2010) .......................................................................... 47
`
`Cybor Corp. v. FAS Techs., Inc.,
`138 F.3d 1448 (Fed. Cir. 1998) .......................................................................... 30
`
`Cytologix Corp. v. Ventana Med. Sys., Inc.,
`424 F.3d 1168 (Fed. Cir. 2005) .......................................................................... 33
`
`Donaldson Co., Inc. v. Baldwin Filters, Inc.,
`2011 WL 2183179 (D. Minn. June 6, 2011)....................................................... 56
`
`iv
`
`

`

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`
`
`
`Emenaker v. Peake,
`551 F.3d 1332 (Fed. Cir. 2000) .......................................................................... 56
`
`Finnegan Corp. v. Int’l Trade Comm’n,
`180 F.3d 1354 (Fed. Cir. 1999) .......................................................................... 34
`
`Fresenius USA, Inc. v. Baxter Int’l, Inc.,
`582 F.3d 1288 (Fed. Cir. 2009) .......................................................................... 56
`
`Gen. Motors Corp. v. Harry Brown’s, LLC,
`563 F.3d 312 (8th Cir. 2009) .............................................................................. 57
`
`Golden Bridge Techn. Inc. v. Nokia, Inc.,
`527 F.3d 1318 (Fed. Cir. 2008) ........................................................ 27, 34, 55, 56
`
`Howes v. Med. Components, Inc.,
`814 F.2d 638 (Fed. Cir. 1987) ...................................................................... 41, 42
`
`In re Gartside,
`203 F.3d 1305 (Fed. Cir. 2000) .......................................................................... 44
`
`In re Kubin,
`561 F.3d 1351 (Fed. Cir. 2009) .......................................................................... 44
`
`Innogenetics, N.V. v. Abbott Labs.,
`512 F.3d 1363 (Fed. Cir. 2008) .......................................................................... 51
`
`Invitrogen Corp. v. Clontech Labs., Inc.,
`429 F.3d 1052 (Fed. Cir. 2005) .......................................................................... 58
`
`J.T. Eaton & Co. v. Atl. Paste & Glue Co.,
`106 F.3d 1563 (Fed. Cir. 1997) .......................................................................... 54
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) .................................................................... 50, 52
`
`Kroupa v. Nielsen,
`731 F.3d 813 (8th Cir. 2013) .............................................................................. 30
`
`KSR Int’l Co. v. Teleflex, Inc.,
`550 U.S. 398 (2007) ...................................................................................... 44, 50
`
`v
`
`

`

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`
`
`Lifescan, Inc. v. Shasta Techs., LLC,
`933 F. Supp. 2d 1243 (N.D. Cal. 2013), rev’d on other grounds,
`734 F.3d 1361 (Fed. Cir. 2013) .......................................................................... 62
`
`Medicine Shoppe Int’l, Inc. v. S.B.S. Pill Dr., Inc.,
`336 F.3d 801 (8th Cir. 2003) .............................................................................. 61
`
`Medrad, Inc. v. MRI Devices Corp.,
`401 F.3d 1313 (Fed. Cir. 2005) .......................................................................... 41
`
`Mikohn Gaming Corp. v. Acres Gaming, Inc.,
`165 F.3d 891 (Fed. Cir. 1998) ............................................................................ 30
`
`Mintz v. Dietz & Watson, Inc.,
`679 F.3d 1372 (Fed. Cir. 2012) .......................................................................... 53
`
`Monsanto Co. v. Bayer Bioscience N.V.,
`363 F.3d 1235 (Fed. Cir. 2004) .......................................................................... 41
`
`New England Braiding Co., Inc. v. A.W. Chesterton Co.,
`970 F.2d 878 (Fed. Cir. 1992) ...................................................................... 31, 33
`
`On-Line Techs., Inc. v. Bodenseewerk Perkin-Elmer GmbH,
`386 F.3d 1133 (Fed. Cir. 2004) .......................................................................... 37
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .............................................. 27, 31, 42
`
`Princeton Biochemicals, Inc. v. Beckman Coulter, Inc.,
`411 F.3d 1332 (Fed. Cir. 2005) .......................................................................... 51
`
`Rentrop v. Spectranetics Corp.,
`550 F.3d 1112 (Fed. Cir. 2008) .......................................................................... 56
`
`Rogers Gp., Inc. v. City of Fayetteville, Ark.,
`629 F.3d 784 (8th Cir. 2010) .............................................................................. 30
`
`Sanofi-Synthelabo v. Apotex, Inc.,
`470 F.3d 1368 (Fed. Cir. 2006) .............................................................. 30, 44, 45
`
`Scimed Life Sys., Inc. v. Advanced Cardiovascular Sys.,
`242 F.3d 1337 (Fed. Cir. 2001) .......................................................................... 37
`
`vi
`
`

`

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`
`
`Sky Techs. LLC v. SAP AG,
`576 F.3d 1374 (Fed. Cir. 2009) .......................................................................... 57
`
`St. Jude Med., Inc. v. Access Closure, Inc.,
`729 F.3d 1369 (Fed. Cir. 2013) .................................................................... 48, 49
`
`Teva Pharms. USA, Inc. v. Sandoz, Inc.,
`723 F.3d 1363 (Fed. Cir. 2013) .......................................................................... 54
`
`Titan Tire Corp. v. Case New Holland, Inc.,
`566 F.3d 1372 (Fed. Cir. 2009) .......................................................................... 45
`
`Unigene Labs., Inc. v. Apotex, Inc.,
`655 F.3d 1352 (Fed. Cir. 2011) .................................................................... 50, 52
`
`Vizio, Inc. v. Int’l Trade Comm’n,
`605 F.3d 1330 (Fed. Cir. 2010) .......................................................................... 47
`
`OTHER AUTHORITIES
`
`Fed. Cir. R. 27(e) ............................................................................................... 58, 63
`
`Fed. R. App. P. 10(a) ......................................................................................... 57, 63
`
`Fed. R. App. P. 30(a) ............................................................................................... 63
`
`D. Minn. L.R. 7.1(a)................................................................................................. 58
`
`
`
`
`
`vii
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`
`
`
`STATEMENT OF RELATED CASES
`
`Plaintiff-Appellee’s counsel is unaware of any related cases within the
`
`meaning of Federal Circuit Rule 47.5.
`
`
`
`
`
`
`viii
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`
`
`STATEMENT OF THE ISSUES
`
`I.
`
`Did the district court correctly find that VSI is likely to prove that
`
`BSC is infringing ‘032 patent, claims 3, 4, and 13; ‘413 patent, claims 4, 9, and 10;
`
`and ‘850 patent, claims 3, 4, and 14, by:
`
`
`
`A.
`
`Construing “a substantially rigid portion proximal of and
`
`operably connected to . . . the flexible tip portion and defining a rail structure
`
`without a lumen” by deciding that “without a lumen” modifies “rail structure” and
`
`rejecting BSC’s argument that the entire substantially rigid portion must be
`
`“without a lumen,” and
`
`
`
`B.
`
`Construing “lumen” as “a passageway through which
`
`interventional cardiology devices are insertable” and rejecting BSC’s contention
`
`that a “lumen” can be any cavity or space of any size, where the district court’s
`
`construction is supported by the patents’ claims and specification and the extrinsic
`
`evidence?
`
`II. Did the district court abuse its discretion in ruling that VSI is likely to
`
`withstand BSC’s obviousness challenge, where (a) BSC’s prior art combinations
`
`do not disclose all elements of the claims, and it would be impossible to use the
`
`references as required by VSI’s patents, (b) BSC improperly engaged in hindsight
`
`and offered no motivation to combine the references, and (c) VSI presented strong
`
`1
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`

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`
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`evidence of secondary considerations of nonobviousness, including commercial
`
`success, industry praise, and BSC’s copying?
`
`III. Did the district court abuse its discretion in finding that VSI
`
`demonstrated it would likely suffer irreparable harm absent a preliminary
`
`injunction?
`
`I. THE PARTIES
`
`STATEMENT OF THE CASE
`
`VSI is a medical device company focused on bringing clinically unique
`
`solutions for vascular diseases to physicians. While VSI has been successful – its
`
`2012 revenue totaled $98 million, and its sales have grown more than 10% in each
`
`of the last nine years – it still has a less than 1% share of the U.S. interventional
`
`cardiology market. A201 ¶ 4; A253 ¶ 128; A448.
`
`BSC markets a diverse group of medical devices through seven divisions.
`
`A415-33; A436. It reported revenue of $7.2 billion in 2012 and is the largest
`
`company in the U.S. market for interventional cardiology devices, with a 40%
`
`share. A223-24; A436; A448-49.
`
`2
`
`

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`
`
`II. VSI’S INVENTION SOLVED A LONG-STANDING PROBLEM IN
`INTERVENTIONAL CARDIOLOGY
`
`A. Cardiac Catheterization Procedures And Guide Catheter
`Limitations1
`
`Interventional cardiac catheterization procedures are a minimally invasive
`
`alternative to open heart surgery, often performed to clear a blockage (stenosis) in
`
`a coronary artery and restore blood flow. A201-03 ¶¶ 6-11. A cardiologist makes
`
`a needle puncture in a remote artery to gain access to the arterial system. A
`
`guidewire is inserted through the needle, after which the needle is removed and an
`
`introducer sheath is inserted over the guidewire. A guide catheter is inserted
`
`through the introducer sheath up the patient’s aorta and into the beginning (ostium)
`
`of the coronary artery. Medical devices such as stents may then be delivered over
`
`the guidewire and through the guide catheter’s lumen to reach the blockage for
`
`treatment. A203-05 ¶¶ 9-11.
`
`A guide catheter must be sufficiently rigid to maintain its distal curve and
`
`position at the ostium of the coronary artery. The guide catheter also must provide
`
`sufficient “backup” support to keep from moving backwards and becoming
`
`dislodged as medical devices are pushed through a tortuous coronary artery and
`
`across a stenosis. Without both guide catheter rigidity and backup support,
`
`medical devices may not be able to enter the coronary artery or cross the stenosis,
`
`
`1 A more detailed description of the technology, including diagrams and
`photographs, is provided in the Root Declaration. A200-11 ¶¶ 5-20.
`
`3
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`causing the procedure to fail. Failure to securely place the guide catheter most
`
`often occurs in challenging cases where the anatomy is tortuous or the stenosis is
`
`severe, which are precisely the cases where treatment is most needed. A207-08
`
`¶¶ 14-15.
`
`B.
`
`Prior Attempts To Solve Guide Catheter Limitations
`
`While it would be desirable to insert the guide catheter deeper into the
`
`coronary artery to provide stronger positioning and backup support, because of the
`
`guide catheter’s curve and rigidity, it generally cannot be safely “deep seated”
`
`(extended past the ostium). A208 ¶ 15. One method used to provide safe deep
`
`seating is the “mother and child” guide system. This involves inserting, for
`
`example, a 120-cm “child” guide catheter with a relatively flexible and straight
`
`distal tip through a standard, 100-cm “mother” guide catheter. Because the child
`
`catheter is flexible and straight, it can safely extend beyond the ostium (where the
`
`mother catheter is positioned) and deep into the artery to provide additional backup
`
`support. A208-09 ¶¶ 16-17.
`
`The mother and child guide system has several drawbacks. First, the system
`
`requires two hemostatic valves: one to seal the mother and another to seal the
`
`child. Second, the combination results in a 120-cm long guide catheter, which
`
`limits the sites that can be treated (most devices are designed for 100-cm guide
`
`catheters). Third, to insert or remove the child catheter, all previously inserted
`
`4
`
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`devices, including guidewires, must be removed. As a result, the mother and child
`
`system was rarely used. A209 ¶ 18.
`
`C. Over-The-Wire And Monorail Systems
`
`The mother and child guide system is an example of over-the-wire (“OTW”)
`
`construction. An OTW catheter has a lumen that runs the entire length of the
`
`catheter and is used for delivery of the catheter over a guidewire and into the
`
`coronary artery. Because an OTW catheter is generally between 100cm and
`
`150cm long, it requires a long (260-300cm) guidewire, requiring two operators to
`
`control both ends of the catheter during deployment. A210 ¶ 19.
`
`Another type of catheter is referred to as a monorail, rapid exchange, single
`
`operator, or sliding rail catheter. All refer to the same type of construction, having
`
`a relatively short (generally 20-40cm) distal lumen used to deliver the catheter over
`
`a guidewire, attached to a longer and stiffer proximal rod used to push and retract
`
`the catheter but running independent of the guidewire. Monorail construction
`
`allows the use of shorter guidewires and a single operator for delivery. A211 ¶ 20;
`
`A256-60.
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`D. VSI’s “Game-Changing” GuideLiner Catheter
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`In 2004, VSI began working on a new idea for a guide extension catheter
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`that would provide “mother and child” guide extension without the disadvantages
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`of OTW construction. That idea became GuideLiner, commercially introduced in
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`2009, which was the first commercial device to provide the advantages of guide
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`extension with the ease of monorail delivery. A211-12 ¶ 21.
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`VSI’s GuideLiner catheter
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` GuideLiner consists of a flexible, tubular portion with a lumen, a
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`substantially rigid portion with a pushrod, and a transitional collar section between
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`them. A212 ¶ 23.
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`1. GuideLiner’s Flexible Portion
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`The distal end (the left side above) of GuideLiner is a relatively flexible tube
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`with a lumen. The distal end has three zones: a very flexible yellow tip, a less
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`flexible yellow coil reinforced portion, and a further less flexible blue portion
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`made from stiffer polymer. A212 ¶ 22. GuideLiner’s flexible portion is inserted
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`through the distal end of the guide catheter so that the distal portion is “deep-
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`seated” in the coronary artery.
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` GuideLiner Coil reinforced portion _
` very flexible tip More flexible Less flexible
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`By extending GuideLiner’s flexible portion past the end of the guide catheter and
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`into the coronary artery, GuideLiner provides effective deep seating without the
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`risks (e.g., vessel perforation) associated with deep seating standard guide
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`catheters. In the figure below on the left, a guide catheter has backed out of the
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`coronary ostium. On the right, GuideLiner is deep seated in the coronary artery,
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`providing a secure passageway to deliver devices deep into the coronary artery.
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`A213-14 ¶¶ 27-28. Deep seating of GuideLiner also allows stent delivery in
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`previously impossible procedures. In the figure below on the left, the stent cannot
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`navigate the artery’s sharp downward angle to reach the stenosis. On the right, use
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`of GuideLiner’s flexible extension changes the artery’s sharp angle into a gentle
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`curve, allowing the stent delivery to the stenosis.
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`A215 ¶ 29.
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`2. GuideLiner’s Substantially Rigid Portion
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`The proximal portion of GuideLiner is a substantially rigid pushrod. The
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`proximal end of the pushrod is embedded into a tab to prevent it from being
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`inadvertently pushed too far into the guide catheter during deployment. A213
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`¶¶ 24-25.
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`GuideLiner substantially rigid pushrod
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`GuideLiner’s monorail construction provides multiple advantages over the
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`OTW construction used in “mother and child” systems. Because only the pushrod
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`extends through the hemostatic valve, a second hemostatic valve is unnecessary
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`and device length is not limited. The monorail construction also allows guidewires
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`previously placed in the artery to remain in place while delivering GuideLiner.
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`A215-16 ¶ 30.
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`3. GuideLiner’s Transition Collar
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`GuideLiner’s flexible portion is joined to the substantially rigid pushrod
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`with a transitional collar portion. The collar allows devices such as stents to enter
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`the flexible portion when delivered through the guide catheter. A212-13 ¶ 23.
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` GuideLiner collar side view GuideLiner collar top down view
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`VSI’s collar has a side opening with a non-perpendicular entry angle,
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`allowing for easy entry of devices and transmitting force from the relatively small
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`pushrod to the flexible tube. The angled opening directs the pushrod’s
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`advancement force to the catheter circumferentially and in the intended direction of
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`travel of the guide catheter extension, resulting in advancement of the flexible tube
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`through the guide catheter without jamming or twisting. A1091-92 ¶ 18. The
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`shaping of the entry to the flexible tube also assists in allowing entry of an
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`interventional cardiology device into the flexible tube portion, by maximizing use
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`of the space inside the guide catheter, so that there is no obstruction. A1092 ¶ 19.
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`E. VSI’S GuideLiner Is Clinically And Commercially Successful
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`Until BSC’s Guidezilla, VSI’s GuideLiner was the only guide extension
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`catheter available worldwide that provided the benefit of rapid exchange. A219-
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`22 ¶ 44; A246-47 ¶ 107; A334-385. Cardiologists hail GuideLiner as a “game-
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`changing device” and a substantial advance in interventional cardiology,
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`describing the clinical benefits of GuideLiner as allowing them “to treat arteries
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`previously deemed untreatable” and “to successfully complete previously
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`unimaginable interventions.” A220 ¶ 44(a); A222 ¶ 45; A334-35; A411-14.
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`According to users, because of GuideLiner, “impossible” cases have been made
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`possible, allowing patients to avoid invasive coronary bypass surgery. A220-21
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`¶ 44 (b), (f); A336-40; A369-73. Multiple journal articles have been published and
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`medical symposia held on GuideLiner. A219 ¶ 43; A329-409.
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`By promoting these clinical benefits, VSI created a new $20 million market
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`that continues to grow. A201 ¶ 4; A247 ¶ 110. GuideLiner is VSI’s fastest
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`growing product, and after just three years, GuideLiner was on track to be VSI’s
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`highest-selling product. A218 ¶¶ 39-41. In addition, GuideLiner’s one-of-a-kind
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`nature and substantial utility make it VSI’s most visible product, opening doors for
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`VSI’s sales force to many new customers. A218-19 ¶ 42; A249 ¶ 115; A1309-10.
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`III. VSI’S GUIDELINER PATENTS
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`On May 3, 2006, VSI filed a patent application on the GuideLiner invention.
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`The application led to three U.S. patents: No. 8,048,032 (‘032 patent) (device),
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`issued November 1, 2011; No. 8,142,413 (‘413 patent) (method for using the
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`device), issued March 27, 2012; and No. 8,292,850 (‘850 patent) (system
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`comprised of the device and a standard guide catheter), issued October 23, 2012
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`(collectively, “VSI’s patents”). A217 ¶¶ 32-36; A52-116.
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`VSI’s patents have independent claims broadly claiming the flexible tubular