CASE 0:17-cv-01969-PJS-TNL Document 56 Filed 03/14/18 Page 1 of 38
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`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
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`
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`QXMédical, LLC,
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`v.
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`Vascular Solutions, LLC and
`Teleflex Innovations S.à.r.l.’s,
`
`
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`
`
`
`
`
`
`Plaintiff and Counterclaim
`Defendant,
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`Defendants and Counterclaim
`Plaintiffs.
`
`
`No. 17-cv-01969-PJS-TNL
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`QXMÉDICAL, LLC’S OPENING
`CLAIM CONSTRUCTION
`MEMORANDUM
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`Page 1
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`CASE 0:17-cv-01969-PJS-TNL Document 56 Filed 03/14/18 Page 2 of 38
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`
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`TABLE OF CONTENTS
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`Page
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`TABLE OF AUTHORITIES ............................................................................................ iii
`
`INTRODUCTION .............................................................................................................. 1
`
`FACTUAL BACKGROUND ............................................................................................ 2
`
`A.
`
`VSI’s Patents-In-Suit ................................................................................... 2
`
`1.
`
`2.
`
`The Problem: Dislodgement of Standard Guide Catheters
`from the Ostium of the Coronary Arteries ........................................ 4
`
`The Solution: a “Coaxial Guide Catheter” with a
`“Substantially Rigid” Portion formed from Cutdown
`Hypotube ........................................................................................... 7
`
`3.
`
`The Asserted Claims of the VSI Patents ......................................... 11
`
`B.
`
`The Hypothetical Person of Ordinary Skill in the Art ............................... 13
`
`ARGUMENT ................................................................................................................... 13
`
`I.
`
`LEGAL STANDARDS APPLICABLE TO CLAIM
`CONSTRUCTION ..................................................................................... 13
`
`II.
`
`CONSTRUCTION OF THE DISPUTED CLAIM TERMS ..................... 15
`
`A.
`
`Term Nos. 1 and 2: “substantially rigid” and “flexible”
`should be construed according to the ordinary meaning of the
`words. .............................................................................................. 16
`
`1.
`
`2.
`
`3.
`
`The ordinary meanings of “substantially rigid” and
`“flexible” are consistent with the way the terms are
`used in the claims ................................................................. 17
`
`QXM’s proposed constructions are also supported by
`the patents’ specification ..................................................... 18
`
`QXM’s proposed constructions are supported by the
`prosecution history ............................................................... 20
`
`B.
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`Term No. 4: “defining a rail structure without a lumen” ............... 22
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`C.
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`D.
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`1.
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`2.
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`“Defining a rail structure” ................................................... 23
`
`“Without a Lumen” .............................................................. 26
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`Term No. 5: “side opening” and “segment defining a
`partially cylindrical opening” ......................................................... 28
`
`Term Nos. 8, 9, and 10: “a material forming the segment
`defining the side opening,” “partially cylindrical opening …
`formed from a material,” and “segment defining the partially
`cylindrical opening having an angled proximal end formed
`from a material” ............................................................................. 31
`
`CONCLUSION ................................................................................................................ 33
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`
`
`
`CASES
`
`TABLE OF AUTHORITIES
`
`
`
`Page
`
`Biogen, Inc. v. Berlex Labs., Inc.,
`318 F.3d 1132 (Fed. Cir. 2003) .................................................................................. 15
`
`BreathableBaby, LLC v. Crown Crafts, Inc.,
`No. 12-CV–0094 (PJS/TNL), 2013 WL 5230724 (D. Minn. Sept. 17, 2013) ........... 17
`
`CCS Fitness, Inc. v. Brunswick Corp.,
`288 F.3d 1359 (Fed. Cir. 2002) .................................................................................. 14
`
`Goodyear Dental Vulcanite Co. v. Davis,
`102 U.S. 222 (1880) ................................................................................................... 15
`
`GPNE Corp. v. Apple Inc.,
`830 F.3d 1365 (Fed. Cir. 2016) .................................................................................. 19
`
`Halliburton Energy Servs. v. M-I LLC,
`514 F.3d 1244 (Fed Cir. 2008) ................................................................................... 17
`
`Howes v. Med. Components, Inc.,
`814 F.2d 638 (Fed. Cir. 1987) .................................................................................... 27
`
`ICU Med., Inc. v. Alaris Med. Sys., Inc.,
`558 F.3d 1368 (Fed. Cir. 2009) .................................................................................. 19
`
`Markman v. Westview Instruments, Inc.,
`52 F.3d 967 (Fed. Cir. 1995) .................................................................................. 2, 15
`
`N. Am. Container, Inc. v. Plastipak Packaging, Inc.,
`415 F.3d 1335 (Fed. Cir. 2005) .................................................................................... 2
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) ............................................................................ 13, 14
`
`Regents of the Univ. of Minn. v. AGA Med. Corp.,
`660 F. Supp. 2d 1037 (D. Minn. 2009) ...................................................................... 17
`
`Teva Pharm. USA, Inc. v. Sandoz, Inc.,
`789 F.3d 1335 (Fed. Cir. 2015) .................................................................................. 15
`
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`Thorner v. Sony Computer Entm’t Am. LLC,
`669 F.3d 1362 (Fed. Cir. 2012) .................................................................................. 14
`
`Trustees of Columbia Univ. in City of New York v. Symantec Corp.,
`811 F.3d 1359 (Fed. Cir. 2016) .................................................................................. 14
`
`VirnetX, Inc. v. Cisco Sys., Inc.,
`767 F.3d 1308 (Fed. Cir. 2014) .................................................................................. 19
`
`Vitronics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996) .............................................................................. 14, 15
`
`York Prods., Inc. v. Cent. Tractor Farm & Family Ctr.,
`99 F.3d 1568 (Fed. Cir. 1996) .................................................................................... 14
`
`STATUTES
`
`35 U.S.C. § 112 ................................................................................................................ 17
`
`35 U.S.C. § 251 .................................................................................................................. 2
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`INTRODUCTION
`
`Plaintiff and Counterclaim-Defendant QXMédical, LLC (“QXM”) requests that
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`the Court construe the disputed claim terms of the six patents-in-suit: US 8,048,032;
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`US 8,142,413; RE45,380; RE45,760; RE45,776; and RE45,116 (“the patents-in-suit” or
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`“VSI’s patents”).
`
`In April 2017, Defendant and Counterclaim Plaintiff Vascular Solutions, LLC
`
`(“VSI”) sent QXM a letter alleging that QXM’s Boosting Catheter product infringed
`
`VSI’s patents. (2d Am. Compl. [Dkt. #46] Ex. A.) QXM does not believe it infringes
`
`any of the patents. (Id. ¶ 12.) However, QXM customers and partners are unwilling to
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`purchase a product that could subject them to an infringement suit by VSI.
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`QXM, therefore, filed this action for a declaratory judgment of non-infringement.
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`(2d Am. Compl. [Dk. #46].) VSI counterclaimed for infringement. (Countercl. [Dkt.
`
`#49].) As an affirmative defense, QXM alleges VSI’s patents are also invalid. (Affirm.
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`Defenses [Dkt. #55] ¶ 3.)
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`The parties dispute construction of seven terms in the table attached as Exhibit 1 to
`
`the Joint Claim Construction Statement. (Dkt. #36, Ex. 1, Table of Dispute Terms.)1 For
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`the reasons below, QXM respectfully requests that the Court adopt the constructions
`
`
`1 The remaining disputed terms are Nos. 1, 2, 4, 5, 8, 9, and 10. Term No. 3 concerns the
`boundary of the “flexible tip portion” and only addresses QXM’s indefiniteness defense.
`The parties agreed at the Status Conference on February 17, 2018 (Dkt. #41) not to brief
`indefiniteness issues and that indefiniteness can be addressed at summary judgment, trial
`or appropriate time. (Dkt. #54). QXM also agrees to VSI’s proposed construction for
`term Nos. 6 (“interventional cardiology devices”) and 7 (“insertable”).
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`1
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`proposed by QXM in the parties’ Joint Statement, in accordance with Markman v.
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`Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995), aff’d, 517 U.S. 370 (1996).
`
`FACTUAL BACKGROUND
`
`A.
`
`VSI’s Patents-In-Suit
`
`VSI alleges infringement of the following claims of the patents-in-suit:
`
`1. 8,048,032 (“’032 patent”) claims 3, 8 (2d Am. Compl. [Dkt. #46] Ex. H);
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`2. 8,142,413 (“’413 patent”) claim 9 (Id. Ex. I);
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`3. RE45,380 (“RE’380 patent”) claims 1, 3, 8 (Id. Ex. D);
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`4. RE45,760 (“RE’760 patent”) claims 25, 30, 31, 32, 48 (Id. Ex. E);
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`5. RE45,776 (“RE’776 patent”) claims 25, 32, 36, 52, 53 (Id. Ex. F); and
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`6. RE45,116 (“RE’116 patent”) claims 25, 34, 53 (Id. Ex. G).
`
`(Dkt. #36 at 1, identifying asserted claims.)
`
`Each VSI patent shares a common specification and drawings. (See “Related
`
`Applications” in each patent.) Each patent claims priority to Application Serial
`
`No. 11/416,629, filed on May 3, 2006, which issued as the ’032 patent. The four reissue
`
`patents are reissues of U.S. Patent No. 8,292,850, which also claims priority to the same
`
`original application filed in 2006.2 A “family tree” showing the relationship amongst the
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`patents-in-suit is attached as Exhibit 1 to the Merrill Declaration.
`
`
`2 The U.S. Patent Office may only reissue a patent as a result of an “error” resulting in the
`patent applicant claiming more or less than he or she had a right to claim in the original
`patent. 35 U.S.C. § 251. A patent owner cannot regain through a reissue patent subject
`matter that was previously surrendered to obtain allowance of the original claims.
`N. Am. Container, Inc. v. Plastipak Packaging, Inc., 415 F.3d 1335, 1349 (Fed. Cir.
`2005). QXM contends that VSI improperly broadened the scope of the original VSI
`
`2
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`VSI’s patents describe the invention as a “coaxial3 guide catheter” for helping
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`cardiologists insert interventional treatment devices, such as stents and balloons, into the
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`coronary arteries. (’032 patent,4 Abstract.) The “coaxial guide catheter . . . is deliverable
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`through a standard guide catheter by utilizing a guidewire rail segment to permit delivery
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`without blocking the use of the guide catheter.” (Id., 2:53-56.)
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`VSI’s coaxial guide catheter (12) is shown in Figure 1 of the patents (see below),
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`with the tapered inner catheter (14)5 with which it is used.
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`
`
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`patents by filing reissue applications with claims removing the requirement of a device
`“without a lumen.” QXM contends that the asserted claims of the RE’760, RE’776, and
`RE’116 patents are invalid for violation of the recapture rule. (Dkt. #55 ¶ 4.)
`
`3 “Coaxial” refers to the fact that the “coaxial guide catheter” shares the same axis as the
`standard guide catheter through which it is extended, e.g., like a telescope.
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`4 Where references in the specification and drawings of VSI’s patents are consistent
`through all of the patents-in-suit, reference is made only to the ’032 patent.
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`5 Throughout the patents the coaxial guide catheter is described in conjunction with the
`tapered inner catheter. The asserted claims focus of the coaxial guide catheter.
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`3
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`To appreciate VSI’s alleged invention, it is important to understand the problem it
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`seeks to address—dislodgement of standard guide catheters from the ostium during
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`delivery of interventional devices.
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`1.
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`The Problem: Dislodgement of Standard Guide Catheters from
`the Ostium of the Coronary Arteries
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`In order to treat obstructive heart disease it is necessary to insert a relatively
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`flexible guidewire inside of a “relatively stiff” standard guide catheter, and to advance the
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`guidewire through the guide catheter and beyond the treatment site (such as an occlusion
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`or stenosis of the coronary arteries). (’032 patent, 1:26-29 and 2:30-31.) Access to a
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`treatment site (such as stenosis) using a coronary guidewire and a standard guide catheter
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`is shown below in annotated Figure 7.
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`4
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`Fig. 7 (annotated)
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`Problem
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`Standard guide catheter dislodged
`from the ostium: “back-out”
`
`Guidewire crossing
`stenotic lesion
`Guidewire (64)
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`
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`
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`(’032 patent, Fig. 7 at 68 (guide catheter), 64 (guidewire) and 66 (treatment site).) As
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`shown above, a standard guide catheter is inserted through the aorta and seated at the
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`ostium or entrance to the coronary artery. (Id., 1:30-32; see Fig. 7 at 60.) A guidewire
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`(64) is advanced through the standard guide catheter (66) and into the artery beyond the
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`occlusion or stenosis (66). (Id., 1:32-36.) Interventional devices are threaded over the
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`guidewire, through the standard guide catheter, and advanced to the treatment site.
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`As the patent explains, a standard guide catheter (shown below) is a “relatively
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`stiff” 6 to 8 French6 tube with an internal diameter of 0.070 to 0.088 inches. (’032 patent,
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`2:23-33, 3:6-13.)
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`
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`(Root Decl. ¶¶ 13-16.) Although a standard guide catheter is able to be advanced over
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`the aortic arch to the ostium, it cannot be easily “deep seated” in the ostium without
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`harming the patient. (’032 patent, 1:45-59.) By comparison, a coronary guidewire is
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`0.014 inches in diameter and flexible enough to be inserted beyond the ostium to a
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`treatment site within the narrow coronary artery. (Id., 2:57-62.)
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`A problem occurs when force is applied to the guidewire to advance it past a tough
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`stenotic lesion. Backup force is created, which dislodges the guide catheter from the
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`ostium as shown in Figure 7, causing lack of support and preventing successful treatment.
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`(Id., 1:36-40.) Backup support can be created by “deep seating” the guide catheter—
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`inserting the catheter more deeply into the coronary artery. (’032 patent, 2:25-28.) But
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`deep seating with “a commonly available guide catheter creates the risk that the relatively
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`stiff, fixed curve, guide catheter will damage the coronary artery.” (Id., 2:28-32.)
`
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`6 The French catheter scale (Fr) is commonly used to measure the outside circumference
`of catheters. 1 "French" or "Fr" is equivalent to 1.0 mm of circumference or ~0.33 mm of
`diameter.
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`2.
`
`The Solution: a “Coaxial Guide Catheter” with a “Substantially
`Rigid” Portion formed from Cutdown Hypotube
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`The VSI patents disclose a “coaxial guide catheter” for addressing the problem of
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`dislodgment “by resisting both the axial forces and the shearing forces that tend to
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`dislodge a guide catheter from the ostium of a branch artery.” (’032 patent, 4:66-5:3.)
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`The coaxial guide catheter has a short catheter on the distal end, connected to a longer
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`“rigid portion” formed from a “hypotube” with part of its circumference removed on the
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`proximal end.7
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`The patents describe the coaxial guide catheter (12) as “include[ing] a tip portion
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`[16], a reinforced portion [18], and a substantially rigid portion [20].” (Id., 3:28-30.)
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`Figure 1 below (with the tapered inner catheter removed) shows the identified portions.
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`(tapered inner catheter 14 removed)
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`
`
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`coaxial guide
`catheter (12)
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`Rigid portion (20)
`YELLOW
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`Reinforced
`portion (18)
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`Distal tip
`
`portion (16)
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`(‘032 patent, 6:9-11.) “Tip portion 16 and reinforced portion 18 together form a
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`substantially cylindrical structure.” (Id., 6:29-30 (shown above in blue).)
`
`
`7 Throughout the asserted claims the patents use the terms “distal” and “proximal.” The
`parties agree that “distal” is “a position that is more distant from, or in a direction away,
`the physician.” (Joint Claim Constr. Stat. at 2.) The parties agree that “proximal” is “a
`position that is nearer to, or in the direction toward, the physician.” (Id.)
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`7
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`Figure 4 shows a more detailed description of the rigid portion (20) of the coaxial
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`guide catheter.
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`Figure 4 –Modified
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`
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`The rigid portion (20)—yellow in Figure above—is described as being “formed from a
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`hypotube or a section of stainless steel or Nitinol tubing.” (’032 patent, 6:35-37.)
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`Starting with a “full circumference” portion at the distal end, the wall of the hypotube
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`forming the “rigid portion” is removed or cutdown to “hemicylindrical” and then
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`“arcuate” sections. (Id., 6:35-40.) “Rigid portion 20 may extend for approximately
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`ninety cm and include first full circumference portion 34 (approximately 0.25 cm),
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`hemicylindrical portion 36 (approximately seventy five cm), arcuate portion
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`(approximately fifteen cm) and second full circumference portion (approximately three
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`cm.)” (Id., 7:19-25.)
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`Figures 12-16 further show the transition of the rigid portion from full
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`circumference portion, to hemicylindrical portion, to arcuate portion, extending for a
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`distance along the longitudinal axis, and creating a side opening in the rigid portion.
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`side opening
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`distal tube
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`
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`Figs. 12-16 (Annotated)
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`(’032 patent, 5:48-56 and 8:34-43.) The “greater than 180 degree” portion (82) serves to
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`“grip” the tapered inner catheter (14) within the rigid portion (20). (’032 patent, 8:42-
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`47.)
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`As depicted in Figure 8, the coaxial guide catheter (12) with the tapered inner
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`catheter (14) is advanced, through the standard guide catheter (56), and over the
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`guidewire (64) into coronary artery (62), after the standard guide catheter has been placed
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`in the ostium. (’032 patent, 7:47-53.)
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`Fig. 8 (annotated)
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`coaxial guide
`catheter (12)
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`
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`Once the coaxial guide catheter (12) is in the ostium (60), the tapered inner catheter (14)
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`is removed from the inside of the coaxial guide catheter. (’032 patent, 7:45-60.) The
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`coaxial guide catheter (12) remains anchored in the ostium. (Id., 7:60-68; see also 9:44-
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`63.) The substantially rigid portion, now located inside the standard guide catheter (56),
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`provides addition stiffness, and creates backup support resisting dislodgment. (Id., 4:66-
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`5:3; see also Abstract, ’413 patent and claim 2.)
`
`The rigid portion of the coaxial guide catheter (12) provides back up support when
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`a physician applies force to the interventional cardiology device. (’032 patent, 9:64-
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`10:4.) A physician may apply a force to the proximal end of the coaxial guide catheter to
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`resist dislodging from the ostium. (Id. 10:5-8.)
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`3.
`
`The Asserted Claims of the VSI Patents
`
`All of the independent claims of the patents-in-suit require a device with a
`
`proximal portion, including a shaft that is “substantially rigid.” All of the asserted claims
`
`of the ’032, ’413 and RE’380 patents also required a substantially rigid portion “defining
`
`a rail structure without a lumen”.
`
`Asserted claim 3 of the ’032 patent (dependent upon claims 1 and 2) is exemplary
`
`of the asserted claims of the ’032, ’413 and RE’380 patents:
`
`1. A device for use with a standard guide catheter, the standard guide
`catheter having a continuous lumen extending for a predefined length
`from a proximal end at a hemostatic valve to a distal end adapted to be
`placed in a branch artery, the continuous lumen of the guide catheter
`having a circular cross-sectional inner diameter sized such that
`interventional cardiology devices are insertable into and through the
`lumen to the branch artery, the device comprising:
`
` a
`
` a
`
` flexible tip portion defining a tubular structure having a circular
`cross-section and a length that is shorter than the predefined length
`of the continuous lumen of the guide catheter, the tubular structure
`having a cross-sectional outer diameter sized to be insertable
`through the cross-sectional inner diameter of the continuous lumen
`of the guide catheter and defining a coaxial lumen having a cross-
`sectional inner diameter through which interventional cardiology
`devices are insertable; and
`
` substantially rigid portion proximal of and operably connected to,
`and more rigid along a longitudinal axis than, the flexible tip
`portion and defining a rail structure without a lumen and having
`a maximal cross-sectional dimension at a proximal portion that is
`smaller than the cross-sectional outer diameter of the flexible tip
`portion and having a length that, when combined with the length of
`the flexible distal tip portion, defines a total length of the device
`along the longitudinal axis that is longer than the length of the
`continuous lumen of the guide catheter,
`
`
`such that when at least a distal portion of the flexible tip portion is
`extended distally of the distal end of the guide catheter, at least a
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`portion of the proximal portion of the substantially rigid portion
`extends proximally through the hemostatic valve in common with
`interventional cardiology devices that are insertable into the guide
`catheter.
`
`
`2. The device of claim 1 wherein the tubular structure includes a distal
`portion adapted to be extended beyond the distal end of the guide
`catheter while a proximal portion remains within the lumen of the
`guide catheter, such that the device assists in resisting axial and
`shear forces exerted by the interventional cardiology device passed
`through and beyond the coaxial lumen that would otherwise tend to
`dislodge the guide catheter from the branch artery.
`
`
`3. The device of claim 2 wherein the proximal portion of the tubular
`structure further comprises structure defining a proximal side
`opening extending for a distance along the longitudinal axis, and
`accessible from a longitudinal side defined transverse to the
`longitudinal axis, to receive an interventional cardiology device into
`the coaxial lumen while the proximal portion remains within the lumen
`of the guide catheter.
`
`
`(’032 patent, claim 3 (bold added).)
`
`Independent claim 25 of the RE’776 patent is exemplary of the asserted claims of
`
`RE’776, RE’760, and RE’116 patents:
`
`25. A guide extension catheter for use with a guide catheter, comprising:
`
`
`a substantially rigid segment;
`
` a
`
` tubular structure defining a lumen and positioned distal to the
`substantially rigid segment; and
`
` a
`
` segment defining a partially cylindrical opening positioned
`between a distal end of the substantially rigid segment and a
`proximal end of the tubular structure, the segment defining the
`partially cylindrical opening having an angled proximal end,
`formed from a material more rigid than a material or material
`combination forming the tubular structure, and configured to
`receive one or more interventional cardiology devices therethrough
`when positioned within the guide catheter,
`
`
`
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`wherein a cross-section of the guide extension catheter at the
`proximal end of the tubular structure defines a single lumen.
`
`
`(RE’776, claim 25 (bold added).)
`
`B.
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`The Hypothetical Person of Ordinary Skill in the Art
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`
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`Each party’s expert has his own description of the hypothetical person of ordinary
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`skill in the art. (Dkt. #36 [Joint Claim Constr. Stat.] Exs. 2 [Root Decl.] ¶ 34 and 3
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`[Brown Decl] ¶ 15.) QXM’s expert, Brian Brown, opines that a person of ordinary skill
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`in the art at the time of the invention would have been a person having a bachelor’s, or
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`higher level, degree in either biomedical or mechanical engineering, or a medical degree,
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`combined with at least three year’s work experience. (Brown Decl. [Dkt. #36-3] ¶ 15.)
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`VSI’s expert, Howard Root, opines that a person of ordinary skill in the art would have
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`slightly more experience (five years versus three). (Root Decl. [Dkt. #36-2] ¶ 34.) VSI’s
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`expert lacks these qualifications; he is a former corporate attorney, turned CEO.
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`(Root Decl. Ex. A.) In any event, VSI provides no explanation how the difference in the
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`description of the hypothetical person would impact claim construction.
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`ARGUMENT
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`I.
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`LEGAL STANDARDS APPLICABLE TO CLAIM CONSTRUCTION
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`The claims of a patent define the scope of the invention to which the patentee is
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`entitled. Phillips v. AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc). Words
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`of a claim are generally given their ordinary and customary meaning, which is the
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`meaning that the term would have to a person of ordinary skill in the pertinent art at the
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`time of the invention. Id. at 1312-13. “[T]he person of ordinary skill in the art is deemed
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`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
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`1313. In some cases, the ordinary and customary meaning of claim language to a person
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`of ordinary skill in the art may be identical to the meaning of that language to a lay
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`person who is not skilled in the art. Id. at 1314.
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`A patentee is presumed to have intended the ordinary meaning of a claim term in
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`the absence of an express intent to the contrary. See York Prods., Inc. v. Cent. Tractor
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`Farm & Family Ctr., 99 F.3d 1568, 1572 (Fed. Cir. 1996). The terms used in the claims
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`bear a “heavy presumption” that they mean what they say and have the ordinary meaning
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`that would be attributed to those words by persons skilled in the relevant art.
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`CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1366 (Fed. Cir. 2002). There are
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`only two circumstances where a claim is not entitled to its plain and ordinary meaning:
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`when a patentee sets out a definition and acts as his or her own lexicographer, or when
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`the patentee disavows the full scope of the claim term either in the specification or during
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`prosecution. Thorner v. Sony Computer Entm’t Am. LLC, 669 F.3d 1362, 1365 (Fed. Cir.
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`2012).
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`In addition to the claims, “[t]he specification is the ‘single best guide to the
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`meaning of a disputed term,’ . . . and ‘is, thus, the primary basis for construing claims.’”
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`Trustees of Columbia Univ. in City of New York v. Symantec Corp., 811 F.3d 1359, 1362
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`(Fed. Cir. 2016) (quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.
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`Cir. 1996), and Phillips, 415 F.3d at 1315)).
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`CASE 0:17-cv-01969-PJS-TNL Document 56 Filed 03/14/18 Page 20 of 38
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`“Although the prosecution history can and should be used to understand the
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`language used in the claims, it ... cannot ‘enlarge, diminish, or vary’ the limitations in the
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`claims.” Markman, 52 F.3d at 980 (quoting Goodyear Dental Vulcanite Co. v. Davis,
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`102 U.S. 222, 227 (1880)). If the specification and the prosecution history conflict, any
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`ambiguities must be resolved in favor of the specification and the claims. Biogen, Inc. v.
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`Berlex Labs., Inc., 318 F.3d 1132, 1140 (Fed. Cir. 2003) (“Representations during
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`prosecution cannot enlarge the content of the specification.”).
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`Only if an analysis of the intrinsic evidence fails to resolve any ambiguity in the
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`claim language may the court then rely on extrinsic evidence, such as expert declarations.
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`Vitronics, 90 F.3d at 1583 (“In those cases where the public record unambiguously
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`describes the scope of the patented invention, reliance on any extrinsic evidence is
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`improper.”). “Experts may explain terms of art and the state of the art at any given time,
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`but they cannot be used to prove the legal construction of a writing.” Teva Pharm. USA,
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`Inc. v. Sandoz, Inc., 789 F.3d 1335, 1339 (Fed. Cir. 2015). “A party cannot transform
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`into a factual matter the internal coherence and context assessment of the patent simply
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`by having an expert offer an opinion on it.” Id. at 1342.
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`II.
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`CONSTRUCTION OF THE DISPUTED CLAIM TERMS
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`QXM respectfully requests that the Court construed the disputed terms in
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`accordance with the proposed constructions set forth below.
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`
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`CASE 0:17-cv-01969-PJS-TNL Document 56 Filed 03/14/18 Page 21 of 38
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`A.
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`Term Nos. 1 and 2: “substantially rigid” and “flexible” should be
`construed according to the ordinary meaning of the words.
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`Claim Term
`“substantially rigid”
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`(’032, ʼ413, and RE’380,
`claim 1; RE’760, claims 25
`and 48; RE’776, claims 25,
`52, and 53; RE’116, claims
`25 and 52)
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`“flexible”
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`(’032, ʼ413, and RE’380,
`claim 1)
`
`QXM’s Construction
`“largely, but not wholly
`unable to bend or be forced
`out of shape; not flexible”
`
`“capable of bending; not
`rigid”
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`VSI’s Construction
`“rigid enough to allow the
`device / coaxial guide
`catheter / guide extension
`catheter to be advanced
`within the guide catheter”
`
`
`No construction necessary.
`“Flexible should be given
`its plain and ordinary
`meaning”
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`
`
`Both parties request construction of the term “substantially rigid.” (Dkt. #36,
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`Term No. 1.) QXM disputes infringement on the grounds that the accused Boosting
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`catheter uses a twin-wire shaft that is entirely flexible, and with no part that is
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`“substantially rigid.”
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`QXM also requests construction of the term “flexible.” (Id., Term No. 2.) The
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`terms “substantially rigid” and “flexible” are used within the same claims to distinguish
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`different parts of the same invention. Therefore, QXM addresses both terms together.
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`The terms “substantially rigid” and “flexible” should be construed in accordance
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`with their ordinary meanings because the specification provides no special definition for
`
`the terms, and the claims use the terms in accordance with their ordinary meanings. In
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`addition, construction in accordance with the terms’ ordinary meaning is supported by the
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`specification and consistent with the prosecution history.
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`CASE 0:17-cv-01969-PJS-TNL Document 56 Filed 03/14/18 Page 22 of 38
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`1.
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`The ordinary meanings of “substantially rigid” and “flexible” are
`consistent with the way the terms are used in the claims
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`The ordinary meaning of “substantially rigid” means “largely, but not wholly
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`unable to bend or be forced out of shape; not flexible.”8 (See Merrill Decl. Exs. 2-11.)
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`See, e.g., BreathableBaby, LLC v. Crown Crafts, Inc., No. 12-CV–0094 (PJS/TNL), 2013
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`WL 5230724, at *7 (D. Minn. Sept. 17, 2013) (defining “substantially” by referencing the
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`American Heri