CASE 0:19-cv-01760-PJS-TNL Document 184 Filed 12/06/19 Page 1 of 27
`
`UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF MINNESOTA
`
`
`
`VASCULAR SOLUTIONS LLC,
`TELEFLEX INNOVATIONS S.à r.l.,
`ARROW INTERNATIONAL, INC.,
`and TELEFLEX LLC,
`
`
`
`v.
`
`MEDTRONIC, INC., and
`MEDTRONIC VASCULAR, INC.,
`
`
`
`
`
`
`
`
`
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`
`
`No. 19:cv-01760-PJS-TNL
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`
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`Jury Trial Demanded
`
`CONFIDENTIAL
`FILED UNDER SEAL
`
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`
`
`Plaintiff,
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`Defendant.
`
`
`PLAINTIFFS’ REPLY BRIEF IN SUPPORT OF
`MOTION FOR PRELIMINARY INJUNCTION
`
`
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`Page 1
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`Medtronic Exhibit 1520
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`CASE 0:19-cv-01760-PJS-TNL Document 184 Filed 12/06/19 Page 2 of 27
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`
`I.
`
`TABLE OF CONTENTS
`
`VSI IS LIKELY TO SUCCEED ON THE MERITS ............................................... 1
`
`A. Medtronic Has Not Raised a Substantial Question of Non-Infringement..... 1
`
`1.
`
`2.
`
`3.
`
`The ‘379 Patent Does Not Require Insertion Into a Guide Catheter . 1
`
`The ‘380 Patent Does Not Require a Direct Connection Between the
`Substantially Rigid and Flexible Tip Portions ................................... 2
`
`Medtronic’s Arguments With Respect to the ‘760 Patent Ignore the
`Proper Construction of “One French Size” ........................................ 4
`
`B. Medtronic Has Not Raised a Substantial Question of Invalidity .................. 4
`
`1.
`
`Medtronic is Unlikely to Prove That Itou Is Prior Art ....................... 4
`
`a.
`
`b.
`
`The Undisputed Evidence of Prior Conception ...................... 5
`
`The Undisputed Evidence of Prior Reduction to Practice ...... 6
`
`2.
`
`Even if Itou is Prior Art, It Fails to Call Into Question the Validity of
`Many of the Infringed Claims ............................................................ 8
`
`C.
`
`D.
`
`Alleged Invalidity Based on Kontos and Ressemann ................................... 9
`
`Alleged Invalidity Under § 112 ................................................................... 10
`
`II. VSI WILL BE IRREPARABLY HARMED WITHOUT AN INJUNCTION ...... 13
`
`A.
`
`The BSC History Foreshadows the Irreparable Harm That Telescope
`Will Cause ................................................................................................... 13
`
`B. VSI’s Projections Do Not Help Medtronic ................................................. 16
`
`C.
`
`The Mounting Impact of Medtronic’s Infringement Confirms The
`Irreparable Harm to Come ........................................................................... 16
`
`1.
`
`2.
`
`3.
`
`It is Fanciful for Medtronic to Suggest that Telescope Will Not
`Harm VSI ......................................................................................... 17
`
`VSI Has and Will Continue to Suffer Irreparable Price Erosion ..... 18
`
`Lost Sales of Other Products ............................................................ 19
`
`4. Marketing and Sales Force Attrition ................................................ 20
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`Page 2
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`Medtronic Exhibit 1520
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`CASE 0:19-cv-01760-PJS-TNL Document 184 Filed 12/06/19 Page 3 of 27
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`III. BALANCE OF HARMS ........................................................................................ 20
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`IV. PUBLIC INTEREST .............................................................................................. 21
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`Page 3
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`Medtronic Exhibit 1520
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`CASE 0:19-cv-01760-PJS-TNL Document 184 Filed 12/06/19 Page 4 of 27
`
`TABLE OF AUTHORITIES
`
`Cases
`
`ABC Charters, Inc. v. Bronson,
`591 F. Supp. 2d 1272 (S.D. Fla. 2008) .......................................................................... 17
`
`Apple Inc. v. Samsung Elecs. Co.,
`809 F.3d 633 (Fed. Cir. 2015) ....................................................................................... 17
`
`Arctic Cat Inc. v. GEP Power Prods.,
`919 F.3d 1320 (Fed. Cir. 2019) ....................................................................................... 5
`
`Bilstad v. Wakalopulos,
`386 F.3d 1116 (Fed. Cir. 2004) ..................................................................................... 11
`
`Celsis in Vitro, Inc. v. CellzDirect, Inc.,
`664 F.3d 922 (Fed. Cir. 2012) ....................................................................................... 18
`
`Cordis Corp. v. Medtronic AVE,
`339 F.3d 1352 (Fed. Cir. 2003) ..................................................................................... 11
`
`Douglas Dynamics, LLC v. Buyers Prods. Co.,
`717 F.3d 1336 (Fed. Cir. 2013) ....................................................................................... 2
`
`DSL Dynamic Scis., Ltd. v. Union Switch & Signal, Inc.,
`928 F.2d 1122 (Fed. Cir. 1991) ....................................................................................... 7
`
`Ebay v. MercExchange LLC,
`547 U.S. 547 U.S. 388 (2006) ....................................................................................... 13
`
`Ethicon Endo-Surgery, Inc. v. United States Surgical Corp.,
`93 F.3d 1572 (Fed. Cir. 1996) ........................................................................... 11, 12, 13
`
`Golden Blount, Inc. v. Robert H. Peterson Co.,
`438 F.3d 1354 (Fed. Cir. 2006) ....................................................................................... 3
`
`In re Asahi/America Inc.,
`68 F.3d 442 (Fed. Cir 1995) ............................................................................................ 6
`
`InTouch Techs., Inc. v. VGo Commc’ns., Inc.,
`751 F.3d 1327 (Fed. Cir. 2014) ................................................................................. 8, 10
`
`Lampi Corp. v. Am. Power Prods., Inc.,
`228 F.3d 1365 (Fed. Cir. 2000) ..................................................................................... 11
`
`Page 4
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`Medtronic Exhibit 1520
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`CASE 0:19-cv-01760-PJS-TNL Document 184 Filed 12/06/19 Page 5 of 27
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`Mahurkar v. C.R. Bard, Inc.,
`79 F.3d 1572 (Fed. Cir. 1996) ................................................................................. 5, 6, 7
`
`MBO Labs., Inc. v. Beckton, Dickinson & Co.,
`474 F.3d 1323 (Fed. Cir. 2007) ....................................................................................... 3
`
`Metalcraft of Mayville, Inc. v. Toro Co.,
`848 F.3d 1358 (Fed. Cir. 2017) ..................................................................................... 18
`
`Presidio Components, Inc. v. Am. Tech. Ceramic Corp.,
`702 F.3d 1351 (Fed. Cir. 2012) ..................................................................................... 18
`
`QXMédical v. Vascular Soln’s, Inc.,
`2019 U.S. Dist. LEXIS 171088 (D. Minn. Oct. 2, 2019) .......................................... 1, 12
`
`Scott v. Finney,
`34 F.3d 1058 (Fed. Cir. 1994) ......................................................................................... 6
`
`TEK Global S.R.L. v. Sealant Sys. Int’l,
`920 F.3d 777 (Fed. Cir. 2019) ....................................................................................... 17
`
`Tinnus Enters., LLC v. Telebrands Corp.,
`846 F.3d 1190 (Fed. Cir. 2017) ....................................................................................... 3
`
`Wells Fargo Invs., LLC v. Bengtson,
`2007 U.S. Dist. LEXIS 49826 (D. Minn. July 9, 2007) ................................................ 18
`
`Statutes
`
`35 U.S.C. § 112 ............................................................................................... 10, 11, 12, 13
`
`35 U.S.C. §102(e) ................................................................................................................ 5
`
`
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`Page 5
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`Medtronic Exhibit 1520
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`CASE 0:19-cv-01760-PJS-TNL Document 184 Filed 12/06/19 Page 6 of 27
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`I.
`
`VSI IS LIKELY TO SUCCEED ON THE MERITS
`A. Medtronic Has Not Raised a Substantial Question of Non-Infringement
`Medtronic does not dispute infringement of the ‘776 patent. Its arguments for the
`
`other patents are contrary to law and the claim language.
`
`1.
`
`The ‘379 Patent Does Not Require Insertion Into a Guide
`Catheter
`
`
`Medtronic argues that the ‘379 patent cannot be infringed unless and until the
`
`claimed device is actually inserted into a guide catheter. (Dkt.103 at 49-50.) That is
`
`contrary to the claims, which are directed to a “method of forming” a device “adapted for
`
`use with” a standard guide catheter. (Dkt.1-10, 13:61-63; 15:7-9.) That claim language
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`strongly suggests that no guide catheter is required to infringe. This Court held that the
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`phrase “for use with” in claims of other patents-in-suit is a statement of capability and
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`that a catheter alone meets this limitation. QXMédical v. Vascular Soln’s, Inc., 2019 U.S.
`
`Dist. LEXIS 171088, at *19-20 (D. Minn. Oct. 2, 2019) (“QXM SJ Order”). Moreover,
`
`the language Medtronic relies on in claims 25 and 38 states that the length of the device
`
`is such that “when” a distal end portion of the device is extended from one end of the
`
`guide catheter, the proximal end extends out the other end of the guide catheter. (Dkt.1-
`
`10, 14:17-25, 15:29-16:2.) “When” is prospective. This distinguishes Medtronic’s case
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`law and further indicates that the device formed by the claimed method need not actually
`
`be inserted into a guide catheter to infringe.
`
`This claim language is also distinguishable from the “one French” language that
`
`caused this Court to grant partial summary judgment in QXMédical. Medtronic’s IFU
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`Page 6
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`CASE 0:19-cv-01760-PJS-TNL Document 184 Filed 12/06/19 Page 7 of 27
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`states that Telescope is an extension to a “traditional guide catheter.” (Dkt.1-2 at 4.) A
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`traditional guide catheter is 100 cm long, while Telescope is 150 cm long. (Dkt.77 at 39.)
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`Thus, Medtronic’s Telescope is “adapted for use with a standard guide catheter.” If
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`Telescope were not longer than the guide catheter, it would not work.
`
`2.
`
`The ‘380 Patent Does Not Require a Direct Connection Between
`the Substantially Rigid and Flexible Tip Portions
`
`
`Medtronic argues that Telescope does not infringe claim 12 of the ‘380 patent
`
`because it does not have a substantially rigid portion directly connected to a flexible tip
`
`portion. But the claims do not require a direct connection. Claim 12 requires that the
`
`substantially rigid portion be “connected to” the flexible tip portion. (Dkt.1-8, 12:31-33.)
`
`The term “connected to” has frequently been interpreted to encompass both direct and
`
`indirect connections. E.g., Douglas Dynamics, LLC v. Buyers Prods. Co., 717 F.3d 1336,
`
`1342 (Fed. Cir. 2013).
`
`This case is no exception. Claim 12 requires a reinforced portion located between
`
`the flexible tip portion and the substantially rigid portion. (See Dkt.1-8, 12:37-44 (stating
`
`that when the flexible tip portion extends out the distal end of a guide catheter, at least a
`
`portion of the reinforced portion remains in the guide catheter and at least a portion of the
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`substantially rigid section extends proximally through the hemostatic valve.) Moreover,
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`Medtronic’s construction would mean that claim 12 does not cover any embodiments in
`
`the patent. In the disclosed embodiments, the reinforced portion is located between the
`
`flexible tip portion and the substantially rigid portion, as shown, for example, in Figure 1:
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`Page 7
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`CASE 0:19-cv-01760-PJS-TNL Document 184 Filed 12/06/19 Page 8 of 27
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`Rigid portion
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`Reinforced portion
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`Tip portion
`
`
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`(Dkt.1-8 (annotations added).) An interpretation that excludes the preferred
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`embodiments is “rarely if ever correct.” MBO Labs., Inc. v. Beckton, Dickinson & Co.,
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`474 F.3d 1323, 1333 (Fed. Cir. 2007).
`
`
`
`Medtronic also argues that VSI’s claim of indirect infringement fails for lack of
`
`proof of specific instances of direct infringement. However, direct infringement can be
`
`inferred from circumstantial evidence. Tinnus Enters., LLC v. Telebrands Corp., 846
`
`F.3d 1190, 1204 (Fed. Cir. 2017). Claim 12 recites a guide catheter very generically,
`
`covering any guide catheter with which Telescope might be used. (Dkt.1-8, 12:4-11.)
`
`Medtronic’s instruction that Telescope is “required” to be used with a guide catheter
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`(Dkt.1-2 at 5) is sufficient to infer direct infringement by doctors. Golden Blount, Inc. v.
`
`Robert H. Peterson Co., 438 F.3d 1354, 1363 (Fed. Cir. 2006).
`
`
`
`
`
` (Dkt.107.) Is Medtronic seriously contending that any (much less all) of
`
`those
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`1 Medtronic’s argument that it
`
`is not contributing to and inducing infringement of the ‘380 patent is meritless.
`
`1
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`Page 8
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`Medtronic Exhibit 1520
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`CASE 0:19-cv-01760-PJS-TNL Document 184 Filed 12/06/19 Page 9 of 27
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`3. Medtronic’s Arguments With Respect to the ‘760 Patent Ignore
`the Proper Construction of “One French Size”
`
`
`As explained in VSI’s opening papers, the patents-in-suit define (and those of
`
`ordinary skill in the art use) the phrase “one French size” differently from the
`
`mathematical definition of “one French.” (Dkt. 75 at 15; Dkt.77, ¶¶51, 58; Dkt.77-14.)
`
`Medtronic’s directing doctors to use its 6-French Telescope (which has an effective inner
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`diameter of 0.056”) with a 6-French guide catheter having an inner diameter of at least
`
`0.070” induces infringement. (Id.) Medtronic’s non-infringement argument is based on
`
`an erroneous claim construction.
`
`B. Medtronic Has Not Raised a Substantial Question of Invalidity
`In an effort to impress the Court and overwhelm VSI, Medtronic recently filed 13
`
`inter partes review petitions. If invalidity were clear, Medtronic would not need 13 IPRs.
`
`1. Medtronic is Unlikely to Prove That Itou Is Prior Art
`
`Medtronic mischaracterizes its lead reference. The Itou publication does not
`
`disclose a “rapid exchange extension catheter,” nor does it have an “onramp and entry
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`port.” (See Dkt.103 at 3.) The component that Medtronic relies on as allegedly
`
`anticipating VSI’s claims is a suction catheter whose sole purpose is to suction matter
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`from a coronary artery. (Keith Second Decl. ¶13.) Itou does not contemplate inserting
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`interventional cardiology devices or anything else into the suction catheter while it is
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`located in the body. (Id.) Medtronic’s effort to claim that Itou’s suction catheter does the
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`same thing as VSI’s industry-changing GuideLiner invention is without merit.
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`Page 9
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`Medtronic Exhibit 1520
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`CASE 0:19-cv-01760-PJS-TNL Document 184 Filed 12/06/19 Page 10 of 27
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`A key issue is whether Itou’s September 23, 2005 filing date qualifies it as prior
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`art, but Medtronic relegates its entire discussion of that issue to a footnote. (Dkt.103 at
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`40 n.8.) To be prior art under 35 U.S.C. §102(e), a reference must be filed in the U.S.
`
`before the applicant’s invention. Arctic Cat Inc. v. GEP Power Prods., 919 F.3d 1320,
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`1330-32 (Fed. Cir. 2019). Thus, Itou is not prior art if VSI conceived and reduced to
`
`practice its invention before September 23, 2005. Mahurkar v. C.R. Bard, Inc., 79 F.3d
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`1572, 1577-79 (Fed. Cir. 1996). Medtronic bears the burden of proving by clear and
`
`convincing evidence that such prior invention did not occur. Id. at 1578. Moreover,
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`contrary to Medtronic’s footnote, there is no requirement for diligence if reduction to
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`practice occurred before September 23, 2005. Id..2
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`
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`There is no basis in the record to conclude that Medtronic has raised a substantial
`
`question as to whether Itou constitutes prior art. Moreover, Medtronic cannot complain
`
`that it has not had an opportunity to explore factual evidence on this issue. Medtronic
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`served a 30(b)(6) notice on conception and reduction to practice, but then voluntarily
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`withdrew it. (Vandenburgh Decl. Exs. 47-48.)
`
`a.
`
`The Undisputed Evidence of Prior Conception
`
`
`Conception occurs when the inventor forms “a definite and permanent idea of the
`
`complete and operative invention, as it is hereafter to be applied in practice.” Mahurkar,
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`2 Itou also is not prior art if VSI conceived of the invention prior to September 23, 2005
`and exercised reasonable diligence between that date and a later actual or constructive
`reduction to practice. Arctic Cat, 919 F.3d at 1331. VSI diligently worked on Guideliner
`throughout the period from September 2005 to the filing of its patent application in May
`2006. (See Root Decl. ¶¶44-82.)
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`Page 10
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`79 F.3d at 1577. VSI’s conception prior to September of 2005 is undisputable. (See
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`Root Decl. ¶¶4-11, 14, 19, 29-30, 39-43.) Indeed, many of the patent drawings are
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`essentially identical to sketches and drawings created prior to September 2005. (Id. ¶¶7,
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`10, 39; id., Exs. 1, 3, 28.)
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`
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`Medtronic’s technical expert accuses VSI’s inventors of fraud, claiming that they
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`actually obtained the idea from Mr. Itou at the 2004 TCT conference. (Dkt.111 ¶¶24-27.)
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`This offensive accusation is pure speculation based on nothing more than the fact that the
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`Itou Japanese patent application was filed shortly before that conference. (Id.) That fact
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`alone is wholly insufficient to prove that Itou’s suction catheter was disclosed to the
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`inventors or anybody else at TCT in 2004.
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`b.
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`The Undisputed Evidence of Prior Reduction to Practice
`
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`Reduction to practice requires that the inventor confirm that the invention is
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`
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`suitable for its intended purpose. Mahurkar, 79 F.3d at 1578. The amount of testing
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`required to show reduction to practice depends on the nature of the invention. Many
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`cases have found reduction to practice based on little, or even no, testing. In re
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`Asahi/America Inc., 68 F.3d 442, 446-47 (Fed. Cir 1995) (collecting cases; no testing
`
`required for pipe coupling invention); Mahurkar at 1578 (flow and pressure drop testing
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`in inventor’s kitchen sufficient for dual lumen catheter invention); Scott v. Finney, 34
`
`F.3d 1058, 1061-63 (Fed. Cir. 1994).
`
`
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`Before
`
`, VSI created and successfully tested rapid exchange
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`GuideLiner prototypes in a bench-top coronary model that simulated actual usage
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`conditions. (Root Decl. ¶¶8, 11-13, 15-43.) The existence and testing of prototypes is
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`Page 11
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`CASE 0:19-cv-01760-PJS-TNL Document 184 Filed 12/06/19 Page 12 of 27
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`corroborated by many documents, including drawings, an actual prototype, component
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`invoices, and a “Product Requirements” document dated
`
`. (Id., Exs. 4-6,
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`8-30.) VSI prepared a “Product Requirements” document only after a product had been
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`built, tested, and determined to work for its intended purpose. (Id. ¶41.)
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`Medtronic wrongly speculates that VSI’s efforts before
`
` were
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`focused exclusively on a mother-and-child system. The undisputed evidence shows that
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`between
`
`
`
` (Id. ¶¶ 4-43.) It made prototypes of both and tested
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`both. (Id.) That is confirmed by vendor receipts showing creation of components that
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`were unique to the rapid exchange version, such as the cut-down hypotube. (E.g. id.
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`¶¶17-19, 30-32, 36-37.) It is also confirmed by a
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` R&D Update stating that
`
`.” (Id.
`
`¶29; see also id. ¶41.)
`
`Medtronic also wrongly argues that the invention could not be considered reduced
`
`to practice until it was tested in humans. Even when testing is necessary, there is no need
`
`to test the invention in its actual working environment as long as the test environment is
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`sufficiently similar to demonstrate workability. DSL Dynamic Scis., Ltd. v. Union Switch
`
`& Signal, Inc., 928 F.2d 1122, 1125 (Fed. Cir. 1991). Catheter inventions are routinely
`
`determined to work without human testing. (Keith Second Decl. ¶¶ 5-12); see also
`
`Mahurkar, 79 F.3d at 1578.
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`Page 12
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`CASE 0:19-cv-01760-PJS-TNL Document 184 Filed 12/06/19 Page 13 of 27
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`2.
`
`Even if Itou is Prior Art, It Fails to Call Into Question the
`Validity of Many of the Infringed Claims
`
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`To justify a preliminary injunction, VSI need only show that one claim is likely to
`
`be found both valid and infringed. Even assuming Itou is prior art (which it is not), many
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`of the claims identified in VSI’s opening brief are still likely to survive Medtronic’s
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`validity attack. A good example is claim 36 of the ‘776 patent. An important feature of
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`VSI’s GuideLiner V3 is its “half pipe” extended side opening. (Dkt.78 ¶6.) This feature
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`is reflected in claim 36, which recites “at least one inclined region that tapers into a non-
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`inclined region.” (Dkt.1-9, 14:22-25.) Medtronic knowingly adopted this feature into
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`Telescope and emphasizes its importance in advertising. (E.g. Dkt.1-1 at 15, 18.)
`
`Medtronic argues that it would have been obvious to add this feature to Itou based
`
`on Ressemann or Kataishi. (Dkt.103 at 41-42.) Ressemann, however, neither teaches nor
`
`suggests an opening having both an inclined and a non-inclined region. (Keith Second
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`Decl. ¶¶15-22, 24-25.) As for Kataishi, Medtronic omits the important fact that the
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`figures reproduced on page 42 of its brief show the distal end of a suction catheter. (Id.
`
`¶23.) Medtronic has failed to persuasively explain why a teaching of a complex opening
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`at the distal end of a suction catheter would motivate one skilled in the art to add such an
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`opening to the proximal end of Itou’s tube. Medtronic’s argument is nothing more than
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`the sort of hindsight that is the antithesis of a proper obviousness analysis. (Id. ¶¶23, 40);
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`InTouch Techs., Inc. v. VGo Commc’ns., Inc., 751 F.3d 1327, 1351-52 (Fed. Cir. 2014).
`
`Page 13
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`CASE 0:19-cv-01760-PJS-TNL Document 184 Filed 12/06/19 Page 14 of 27
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`Other examples of asserted claims that would clearly not be invalidated even if
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`Medtronic succeeds in proving that Itou is prior art are claim 32 of the ‘760 patent and
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`claim 44 of the ‘379 patent. (Keith Second Decl. ¶¶14-25.)
`
`C.
`
`Alleged Invalidity Based on Kontos and Ressemann
`
`There is a reason why Medtronic focuses so heavily on Itou even in the face of a
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`difficult burden of proving that it is prior art. Medtronic’s “next best” references, Kontos
`
`and Ressemann, are not particularly relevant and, in fact, are no more relevant than the
`
`prior art considered by the PTO during prosecution.
`
`Kontos adds nothing to the validity analysis. Not only was Kontos submitted to
`
`the PTO during the prosecution of the ‘379 patent, Kontos is cumulative of U.S. Patent
`
`No. 5,527,292 (“Adams ‘292”), which was before the PTO in each of the VSI patents
`
`currently at issue. (Id. ¶¶26-34.) Both Kontos and Adams ‘292 are directed to fixed-wire
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`balloon catheter exchanges using a narrow distal tube with a funnel:
`
`Kontos
`
`Adams ‘292
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`Page 14
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`CASE 0:19-cv-01760-PJS-TNL Document 184 Filed 12/06/19 Page 15 of 27
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`(Id. ¶34) Like Adams ‘292, Kontos does not teach or suggest many limitations of the
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`asserted claims. (Id.) The PTO allowed all the presently-asserted claims over Adams
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`‘292; Medtronic has failed to show how Kontos dictates a different result.
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`Ressemann is directed to a suction device that also lacks many limitations of the
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`claims at issue. (Id. ¶¶24-25.) Specifically with respect to the side opening, Ressemann
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`does not show the structure Medtronic alleges. (Id. ¶¶15-22.) The tab portion of
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`Ressemann that Medtronic relies on as disclosing the second inclined section and the
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`non-inclined section is buried below another component in the finished device, is
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`therefore not part of the side opening, and never contacts or directs any interventional
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`cardiology devices. (Id.)
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`Finally, the alleged combinations set forth by Medtronic are also fatally flawed.
`
`(See id. ¶¶35-43.) Medtronic’s reliance on a prior art statement that the device should
`
`“use known medical procedures” (Dkt.103 at 43) is a far cry from the teaching or
`
`motivation to combine needed to prove obviousness. Medtronic’s cutting and pasting
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`parts of one device into another ignores the real-world issues of how or why the various
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`parts from the prior art would be allegedly combined, and the problems that would arise
`
`when such combinations are made. (Keith Second Decl. ¶¶35-43.) Such conclusory
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`allegations of obviousness are insufficient. InTouch Techs., 751 F.3d at 1352.
`
`D.
`
`Alleged Invalidity Under § 112
`
` Medtronic argues that any asserted claim reciting a side opening is invalid if it
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`does not also require that the side opening is part of a claimed “substantially rigid
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`portion.” (Dkt.103 at 46-48.) This is wrong as a matter of law. Even if it were true that
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`the specification does not disclose an embodiment where the side opening is outside the
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`rigid section, there is nothing improper about presenting claims that are broader than the
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`preferred embodiments. See Bilstad v. Wakalopulos, 386 F.3d 1116, 1123-24 (Fed. Cir.
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`2004). There are two exceptions to this general rule: (1) where the technology area is
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`highly unpredictable; or (2) where the specification makes clear that the unclaimed aspect
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`is critical to the invention. Id. at 1125. Many cases have found genus claims to comply
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`with §112 even when the claims are broader than the claims as originally filed. See, e.g.,
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`Cordis Corp. v. Medtronic AVE, 339 F.3d 1352, 1364-65 (Fed. Cir. 2003); Lampi Corp.
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`v. Am. Power Prods., Inc., 228 F.3d 1365, 1377-78 (Fed. Cir. 2000); Ethicon Endo-
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`Surgery, Inc. v. United States Surgical Corp., 93 F.3d 1572, 1582 n.7 (Fed. Cir. 1996).
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`Neither exception exists here. The subject matter of the invention is not highly
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`unpredictable, and Medtronic does not argue otherwise. Moreover, nowhere does the
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`specification indicate that having the side opening in a rigid portion is critical to the
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`invention. To the contrary, the “Summary of the Invention” describes the invention
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`broadly. (Dkt.1-9, 3:15-5:42.) The first seven paragraphs say nothing about the location
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`of the side opening whatsoever. (Id., 3:15-4:10.) The eighth paragraph states that the
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`rigid portion “may” include a cutout portion and a full circumference portion (which
`
`defines the side opening), thus clearly indicating that the proximal opening into the
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`tubular portion need not be part of the rigid portion. (Id., 4:11-15.)
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`Moreover, the specification does disclose that the side opening need not be rigid.
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`Figure 1 shows an embodiment where the opening is located in the “reinforced portion.”
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`(Id., 6:37-41.) And Figures 10-11 show an embodiment where regions of the so-called
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`rigid portion are “perforated by relief cuts” that increase flexibility. (Id., 8:38-62.) The
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`relief cuts are preferably “relatively closely spaced” in the region near the distal end of
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`the rigid portion, thus further increasing flexibility in the region with the side opening.
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`(Id.)
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`As this Court noted in QXMédical, “[n]othing in any of the patents-in-suit says
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`that ‘substantially rigid’ and ‘flexible’ are mutually exclusive.” QXM SJ Order at *5.
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`The entire length of the catheter must, to varying degrees, be both “rigid” and “flexible.”
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`See id. And three of the asserted claims in this motion—claim 25 of the ‘776 patent and
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`claims 25 and 48 of the ‘760 patent—expressly require increased rigidity of the claimed
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`side opening segment relative to all or part of the tubular portion. (Dkt.1-9, 13:36-52;
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`Dkt.1-11, 13:36-14:7, 15:15-53.)3 That, combined with the fact that the specification
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`never states that having the side opening in the rigid portion is a necessary part of the
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`invention, is fatal to Medtronic’s §112 argument.
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`Finally, Medtronic argues that the ‘379 prosecution history proves invalidity under
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`§112. (Dkt.103 at 48.) In doing so, Medtronic makes the error of “confus[ing] a claim
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`not supported by the specification, which is not allowable, with a broad claim, which is.”
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`Ethicon, 93 F.3d at 1582 n.7. The claims that were rejected under §112 during the ‘379
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`prosecution recited a “method of forming” that included a step of “providing a segment
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`defining a side opening” separate from the step of “providing a substantially rigid
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`3 Medtronic advertises that the polymer located in the region of its side opening is quite
`rigid, and the testing performed by VSI’s technical expert bears this out. (Dkt.1-1 at 10,
`19; Dkt.77-16 at ¶20.)
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`segment.” (Dkt.116 at 11-12, 14; Dkt.117 at 18-19.) Thus, the Examiner’s concern
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`appears to have been that there was not written description for a method of forming that
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`involved providing a side opening and a rigid segment in separate forming steps.
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`Importantly, however, VSI subsequently amended the claims to recite the step of
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`“defining a side opening portion,” without specifying whether the side opening portion is
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`part of the reinforced segment, the substantially rigid segment, or some other non-
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`specified segment. (Vandenburgh Decl. Ex.49 at 23, 30, 32-33.) The Examiner agreed
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`that this amendment overcame the §112 rejection. (Id., Ex.50 at 4.) Such an amendment
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`that recites an element without specifying its exact location is proper and complies with
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`§112. Ethicon, 93 F.3d at 1582 n.7.
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`II.
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`VSI WILL BE IRREPARABLY HARMED WITHOUT AN INJUNCTION
`
`A.
`
`The BSC History Foreshadows the Irreparable Harm That Telescope
`Will Cause
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`Contrary to Medtronic’s assertion,
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` does not preclude a finding of
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`irreparable harm here. Ebay v. MercExchange LLC, 547 U.S. 547 U.S. 388, 393 (2006).
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`Medtronic also wrongly asserts that the post-BSC market dynamics show the lack
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`of irreparable harm. The facts show otherwise. In 2013, BSC launched Guidezilla in one
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`size. (Dkt.160). The product
`
`. (Vandenburgh Decl.
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`Ex.27 at 86:3-23; Dkts.79-13, 79-14, 79-15, 79-16.) It was not until mid-2017 that BSC
`
`came out with Guidezilla II, a better design sold in multiple sizes. (Dkt.160; Dkt.78 at
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`¶35.) This is when
`
`
`
` (See Vandenburgh Decl. Ex.46; Jagodzinski Decl. ¶5.) The net
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`result is that
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` of what used to be exclusively a GuideLiner market.
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`(Vandenburgh Decl. Ex.28 (Apr. 2018-Mar. 2019).) Without BSC in the market, VSI
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`would in all likelihood have made those sales.
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`Critically, the harm caused by Guidezilla went beyond lost GuideLiner sales. VSI
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`has been forced to spend time and energy responding to Guidezilla to minimize its impact
`
`in the market. (Vandenburgh Decl. Ex.27 at 125:17-127:11; id., Ex.29.) Before
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`Guidezilla II,
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`Ex.30.) With Guidezilla II,
`
`. (Id.,
`
`
`
` (Id., Ex.27 at 127:20-130:1; id., Ex.29; Jagodzinski Decl. ¶¶5-
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`6.)
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`The threat posed by Medtronic is far worse. Medtronic is over twice the size of
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`BSC. (Vandenburgh Decl. Ex.31.) And with Telescope, Medtronic is executing a
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`comprehensive strategy to
`
`
`
`
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`(Id., Ex.32 at 0012, 0017; id., Ex.33 at 0023; id., ¶ 26.)
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`Medtronic is not only using Telescope to create a new revenue stream, it is using
`
`Telescope
`
`:
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`(Id., Ex.34 at 003 (red emphasis added); see also id., ¶10 and Ex.35 at 2; id., Ex.46;
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`Dkt.78 ¶22; Dkt. 79-17.)
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`Whereas BSC
`
` Guidezilla units in the U.S. in
`
` on the
`
`market, Medtronic forecasts it will
`
` Telescope units in the same amount
`
`of time. (Vandenburgh Decl. Ex.35 at 3-4; Dkt.162 at 46.) Medtronic intends to
`
`
`
` of the guide extension catheter market, with the majority coming from
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`,
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`in that same
`
`. (Vandenburgh Decl. Ex.36 at 003; id., Ex.32 at 0012; id.
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`Ex.39 at 0014-0017; id., Ex.38 at 5.) And Medtronic has
`
`. (Id., Ex.36 at 007; id., Ex.37 at
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`002.)
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`In short, the impact of BSC pales in comparison to what Medtronic has unleashed
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`in the market.
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`B.
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`VSI’s Projections Do Not Help Medtronic
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`Medtronic makes much of VSI’s forecasts for GuideLiner. Those projections do
`
`not support Medtronic’s position. In its 2017 Strategic Plan, VSI projected that
`
`. (Jagodzinski Decl., ¶3; id. at Ex.
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`A. at VSIQXM_E00056236, -56237; Dkt.135.) Telescope was