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`CASE 0:13-cv-01172-JRT-SER Document 43-2 Filed 07/24/13 Page 1 of 1
`
`3,/
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
`
`Vascular Solutions, Inc.,
`
`Civil File No. 13-cv-01172 (JRT-SER)
`
`Plaintiff,
`
`V.
`
`Boston Scientific Corporation,
`
`Defendant.
`
`PLACEHOLDER FOR PLAINTIFF'S
`REPLY MEMORANDUM IN SUPPORT
`OF MOTION FOR PRELIMINARY
`INJUNCTION
`
`This document is a place holder for the following item(s) which has/have been filed in
`conventional or physical form with the Clerk's Office:
`
`Plaintiff's Reply Memorandum in Support of Motion for Preliminary Injunction
`
`If you are a participant in this case, this filing will be served upon you via conventional
`format.
`
`This filing was not e-filed for the following reason(s):
`
`Voluminous Document* (Doc. No. of order granting leave to file conventionally: )
`
`Unable to Scan Documents (e.g., PDF file size of one page larger than 15MB, illegible when
`scanned)
`
` Physical Object (description):
`
`Non Graphical/Textual Computer File (audio, video, etc.) on CD or other media
`
`Item Under Seal pursuant to a court order* (Doc. No. of protective order: _)
`
`Item Under Seal pursuant to the Fed. R. Civ. P. 5.2 and Fed. R. Crim. P. 49.1
`(Doc. No. of redacted version: )
`
`X Other (description): There is no protective order in this case as of yet, but it is
`forthcoming.
`
`* Filing of these items requires Judicial Approval.
`
`E-file this place holder in ECF in place of the documents filed conventionally. File a copy of this Placeholder and a
`copy of the NEF with the Clerk's Office along with the conventionally filed item(s).
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`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
`
`Vascular Solutions, Inc.,
`
`Civil File No. 0:13-cv-01172-JRT-SER
`
`Plaintiff,
`
`V.
`
`Boston Scientific Corp.,
`
`Defendant.
`
`PLAINTIFF'S REPLY
`MEMORANDUM IN SUPPORT OF
`MOTION FOR PRELIMINARY
`INJUNCTION
`
`** REDACTED **
`
`DORSEY & WHITNEY LLP
`J. Thomas Vitt #0183817
`vitt.thomas@dorsey.com
`Heather D. Redmond #0313233
`redmond.heather@dorsey.com
`Shannon L. Bjorklund #0389932
`bjorklund.shannon@dorsey.com
`Suite 1500, 50 South Sixth Street
`Minneapolis, MN 55402-1498
`Telephone: (612) 340-2600
`
`Attorneys for Plaintiff
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`TABLE OF CONTENTS
`
`I.
`
`VSI IS LIKELY TO ESTABLISH BOSTON'S PATENT
`INFRINGEMENT
`
`A.
`
`Boston Literally Infringes the Asserted Claims
`
`1. A Lumen Must Be Open To Allow Passage Of Medical
`Devices
`"Without a Lumen" Applies to the Rail Structure, Not
`the Collar
`Guidezilla's Rail Structure Does Not Have a Lumen
`
`2.
`
`3.
`
`B.
`
`Boston Infringes Under The Doctrine of Equivalents
`
`1.
`
`2.
`
`Boston's Hypotube is the Equivalent of a Rail Structure
`Without a Lumen
`Festo Does Not Bar VSI's Equivalents Claim
`
`II.
`
`BOSTON IS UNLIKELY TO PROVE THAT ALL INFRINGED
`CLAIMS ARE INVALID
`
`A.
`
`VSI Invented a Collar Adams Never Considered
`
`1.
`2.
`
`Adams Patent
`VSI's Innovative Collar
`
`B.
`
`Boston's Prior Art Does Not Disclose All Elements
`
`1.
`
`2.
`
`Boston's Prior Art Does Not Disclose A Tube "Not More
`Than One French Smaller" Than The Guide Catheter
`Boston's Prior Art Does Not Disclose VSI's Collar
`
`C.
`D.
`
`Hindsight Cannot Be Used To Combine Prior Art References
`Secondary Considerations
`
`III.
`
`VSI WILL SUFFER IRREPARABLE HARM
`
`IV. THE BALANCE OF HARMS FAVORS VSI
`
`2
`
`2
`
`2
`
`5
`5
`
`6
`
`6
`6
`
`7
`
`8
`
`8
`11
`
`12
`
`12
`13
`
`16
`17
`
`18
`
`19
`
`V. THE PUBLIC INTEREST FAVORS A PRELIMINARY INJUNCTION 20
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`VI.
`
`THE COURT SHOULD ENJOIN BOSTON’S COPYRIGHT
`
`INFRINGEMENT ............................................................................................. 20
`
`VII. BOND ............................................................................................................... 22
`
`CONCLUSION ............................................................................................................. 22
`
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`TABLE OF AUTHORITIES
`
`CASES
`
`Page(s)
`
`Abbott Labs. v Sandoz, Inc.,
`500 F. Supp. 2d 846 (N.D. 111. 2007), a ’d 544 F.3d 1341 Wed. Cir. 2009) ................. 12
`
`Amazon. com, Inc. v. Barnesandnoble. com, Inc,
`239 F.3d 1343 (Fed. Cir. 2001) ............................................................................................. 7
`
`C & A Pro, LLC v. Pride Solutions, LLC,
`2005 WL 388602 (D. Minn. Jan. 17, 2005) .......................................................................20
`
`Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd.,
`344 F.3d 1359 (Fed. Cir. 2003) .........................................................................................6, 7
`
`Iron Arrow Honor Society v. Heckler,
`464 U.S. 67 (1983) ................................................................................................................21,
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc,
`688 F.3d 1342 (Fed. Cir. 2012) ..................................................................................... 16, 17
`
`Lifescan, Inc. V. Shasta Techs., LLC,
`.--— F. Supp. 2d --- , 2013 WL 1149827 (N.D. Cal. Mar. 19, 2013) ................-....12, 16,18
`
`Merial, Ltd. v. Velcera, Inc.,
`877 F. Supp. 2d 1348 (MD. Ga. 2012) .............................................................................. 18
`
`Microstrategy, Inc. v. Business Object, SA,
`331 F. Supp. 2d 432 (ED. Va. 2004) ...................................................................................7
`
`Mintz v. Dietz & Watson, Inc.,
`679 F.3d 1372 (Fed. Cir. 2012) ........................................................................................... 17
`
`Phillips v. A WH Corp,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ........................................................................2, 3
`
`Rebel Debutante LLC v. Forsythe Cosmetic Group, Ltd,
`799 F. Supp. 2d 558 (M.D.N.C. 2011) ...............................................................................21
`
`Regents v. DakoCytomation Cal,
`517 F.3d 1364 (Fed. Cir. 2008) .............................................................................................7
`
`~
`Titan Tire Corp. v. Case New Holland, Inc.,
`566 F.3d 1372 (Fed. Cir. 2009) ......................................................................................... 7, 8
`
`iii
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`OTHER AUTHORITIES
`
`21 C.F.R. § 801.5 .........................................................................................................................21
`
`iV
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`Boston does not deny that it copied VSI’s patented GuideLiner product and VSI’s
`
`copyrighted Instructions for Use (“IFU”). Boston’s Guidezilla files contain—
`
`_ R
`
`edmond 1] 2. Boston‘watched and waited while its smaller competitor VSI created and
`
`grew a successfiil market for its patented guide extension catheter, and then copied it,
`
`feature-for-feature and word—for-word.
`
`Boston makes two weak arguments to defend its copying. First, Boston argues
`
`noninfringement based on a definition of “lumen” that contradicts the patents, the law,
`
`Boston’s documents, and common sense. The tiny, enclosed, nonfunctional “space” in
`
`the Guidezilla rail structure is not a “lumen.”
`
`Second, Boston raises a new argument —— invalidity based on the Adams patent, an
`
`expired patent Boston acquired nearly twenty years ago. Boston makes no attempt to
`
`Show that the Adams device would work'for any purpose, much less guide extension,
`
`without undue experimentation. Although Boston owned Adams for many years, it never
`
`commercialized a guide extension product until after VSI launched GuideLiner. Then,
`
`Boston did not base Guidezilla on Adams; instead, it copied GuideLiner.
`
`The weakness of Boston’s Adams argument is exposed by its sandbagging
`
`strategy. Boston failed to provide VSI notice of Adams in:
`
`0 May 2006, when VSI’s ‘032 patent application became public;
`
`0 November 2009, when VSI began selling GuideLiner;
`
`- October 2012, when Root asked Ballinger about Guidezilla and provided
`written notice of VSI’s patents;
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`0 April 2013, when Root sent another letter to Ballinger asking the basis for
`any defense, and when Boston first sold Guidezilla without marking with
`the Adams patent number;
`
`0
`
`June 2013, when Boston’s lawyers sent a letter disclosing only Boston’s
`“lumen” defense, and during counsel’s conferences regarding this motion.
`
`Root W 51-52, 60, Exs. 20, 22, 32‘; Second Root 11 3; Redmond 1111 5-12. Boston first
`
`disclosed Adams at the end of the Root deposition, and has refused to produce its Adams
`
`files. Redmond 1111 10-16.
`
`With regard to ‘032 patent claims 3, 4, 8, l3 and 17; ‘413 patent claims 4, 9, 10,
`
`and 13; and ‘850 patent claims ‘3, 4, 8, 14 and 18, Boston’s invalidity defense is entirely
`
`‘ without basis.1 Boston concedes that Adams does not disclose all the elements of those
`
`claims, and provides no reason why its prior art “renders obvious” VSI’s solution to the
`
`guide extension problem.
`
`I.
`
`VSI IS LIKELY TO ESTABLISH BOSTON’S PATENT INFRINGEMENT
`
`Boston concedes that Guidezilla meets every limitation of the asserted claims
`
`except one. For its sole noninfringement defense, Boston claims that Guidezilla does not
`
`have a rail structure “without a lumen” — contradicting the plain claim language, claim
`construction principles, and its own documents.
`V
`
`A.
`
`Boston Literally Infringes the Asserted Claims
`
`1.
`
`A Lumen Must Be Open To Allow Passage Of Medical Devices
`
`VSI’s opening brief established that, when the claims, patent specification, and file
`
`history are analyzed as required by Phillips v. AWH Corp, 415 F.3d 1303, 1313-17 (Fed.
`
`‘ Because VSI need only establish that it is likely to succeed in proving Boston’s
`infringement of one valid claim, VSI focuses on those claims for which the Court can
`easily reject Boston’s defense.
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`Cir. 2005) (en banc), “lumen” has a clear meaning:
`
`the interior of a tubular structure,
`
`. open at both ends to allow the passage of medical devices. VSI Br. at 21-25.
`
`Boston asks the Court to construe “lumen” to encompass any space or cavity
`
`within a tubular structure — no matter how small, and regardless of whether it is open or
`
`closed, allows passage of devices, or is functional. Opp. at 11-14; Vrba '[l 6. Boston
`ignores the patents’ specification and prosecution history, in favor of extrinsic
`
`dictionaries and irrelevant court opinions. Boston’s dictionary definitions are ambiguous
`
`at best; blood vessels, ducts, and intestines, for example, are open on both ends so matter
`
`can pass through.
`
`More fimdamentally, by starting with extrinsic evidence divorced from the patents,
`
`Boston follows a methodology rejected by the Federal Circuit because it:
`
`placed too much reliance on extrinsic sources such as
`dictionaries, treatises, and encyclopedias and too little on
`intrinsic sources, in particular the specification and
`prosecution history. .
`.
`. [H]eavy reliance on the dictionary
`divorced from the intrinsic evidence risks transforming the
`meaning of the claim term to the artisan into the meaning of
`the term in the abstract, out of its particular context, which is
`the specification.
`
`Phillips, 415 F.3d at 1320-21; see also Renishaw PLC v. Marposs Societa ’ per Azioni,
`
`158 F.3d 1243, 1250 (Fed. Cir. 1998).
`
`Boston’s expert adds nothing to its claim construction — he did not even perform
`
`his own analysis. Boston’s lawyers prepared its proposed definition. Redmond Ex. E at
`
`103. After testifying that he had reviewed only the patent claims, and not their
`
`specifications, id. at 69-71, Vrba later clarified that he had read other parts of the ‘032
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`patent but not in one sitting. Id. at 104-05. Vrba's sole investigation regarding the
`
`meaning of "lumen" was one Google search revealing a Wikipedia definition related to
`
`the gut. Id. at 102-03. Vrba identified no device with a "lumen" having closed ends.
`
`Had Vrba investigated extrinsic evidence in the relevant field (including Boston's
`
`own documents), he.would have discovered "lumen" consistently used as defined by VSI.
`
`VSI cited context-specific articles and excerpts from Boston's own website, all of which
`
`demonstrate that a lumen is a passageway. Root Exs. 33-35. Boston's Adams patent
`
`uses "lumen" to refer to the interior of a tube through which something can pass.
`
`Redmond Ex. A.
`
`No document references Guidezilla's hair-width, closed, nonfunctional space in its
`
`rail structure as a lumen. To the contrary,IMMIIIIIIIIIIIII.M.P
`fisairmsmistareatismesariwilimiar
`
`Redmond Ex. H.
`
`Ex. I.
`
`E.g., Redmond
`
`Finally, Boston's construction violates common sense. A person of ordinary
`
`skill — having read in the patent that the rail structure provides pushability and can be
`
`formed from a hypotube — would never conclude that "any" space creates a lumen.
`
`Taken to the extreme, "any" space could encompass an air bubble one micron across — an
`
`absurd result.
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`2.
`
`"Without a Lumen" Applies to the Rail Structure, Not the
`Collar
`
`Boston argues Guidezilla does not infringe because its substantially rigid portion
`
`includes a collar with a lumen. Opp. at 10-11.2 The premise of Boston's argument
`
`ignores the plain claim language. The claims do not require a "substantially rigid portion
`
`without a lumen." Instead, they require a substantially rigid portion "defining a rail
`
`structure without a lumen." "Without a lumen" modifies rail structure in the
`
`substantially rigid portion, not the substantially rigid portion as a whole, and not the
`
`collar transition between the substantially rigid portion and the flexible tip. Indeed,
`
`Boston's construction erases claims such as '032 patent, claim 13, which requires that the
`
`substantially rigid portion have both a rail structure without a lumen and a collar with a
`
`lumen. The presence of a lumen through the device's collar is irrelevant to whether the
`
`substantially rigid portion defines a rail structure without a lumen.
`
`3. Guidezilla's Rail Structure Does Not Have a Lumen
`
`Properly construed, Guidezilla's rail structure is "without a lumen." Boston's
`
`expert and documents establish that its pushrod hypotube is closed on both ends.
`
`Redmond Exs. E at 101-02, J. No medical device can pass through ital..
`
`Redmond Ex.
`
`H.
`
`2 Although irrelevant, Boston cites only portions of Root's testimony about GuideLiner to
`establish that Guidezilla's collar is part of the substantially rigid portion, Opp. at 10,
`unfairly ignoring other testimony where he clarifies the testimony. Redmond Ex. B at
`96; Second Root ¶ 43.
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`B.
`
`Boston Infringes Under The Doctrine of Equivalents
`
`1. Boston's Hypotube is the Equivalent of a Rail Structure Without
`a Lumen
`
`There is no meaningful difference between the claimed "rail structure without a
`
`lumen" and Guidezilla's pushrod hypotube.
`
`Redmond Ex. K at 769. The space in the Guidezilla pushrod that Boston calls a "lumen"
`
`measures 0.0044 inches — a human hair's width. Second Root ¶ 44. If Boston does not
`
`literally infringe, then the doctrine of equivalents was designed for this case — Boston
`
`admitted in pre-litigation documents that the tiny, closed, nonfunctional space inside its
`
`hypotubilIllMNIIIIIINP' but argues in Court that the space is a "lumen" to avoid
`
`infringement.
`
`Boston's suggestion that Root is not a "person of ordinary skill" and cannot
`
`establish equivalence is easily dismissed. Opp. at 17. Root has worked on vascular
`
`devices for sixteen years and is an inventor on some ten patents in this field. Unlike
`
`Vrba, who barely reviewed the patents and has never seen or examined the accused
`
`product, Redmond Ex. E at 65, 100, Root reviewed the patents and file histories and
`
`examined and tested Guidezilla. Vrba's failure to provide an opinion regarding
`
`equivalence speaks volumes about the argument's weakness.
`
`2. Festo Does Not Bar VSI's Equivalents Claim
`
`Prosecution history estoppel does not bar VSI's equivalents claim, because "the
`
`rationale underlying the narrowing amendment bore no more than a tangential relation to
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`the equivalent in question." Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd.,
`
`344 F.3d 1359, 1369 (Fed. Cir. 2003) (quotation omitted). The "rail structure without a
`
`lumen" amendment has no relationship to the tiny, nonfunctional cavity in Guidezilla's
`
`hypotube.
`
`During prosecution, the examiner rejected VSI's claims in view of prior art
`
`disclosing "a tubular structure [with a] lumen through which cardiology devices are
`
`insertable." Redmond Ex. F at 186. VSI's claims were distinguished over this art
`
`because the claims' rail structure did not allow devices to pass. Id. at 174-75. Boston's
`
`use of a "fake" lumen through which devices cannot pass is tangential to this amendment.
`
`When an amendment focuses on one portion of a limitation, and the infringer
`
`develops an equivalent related to a different aspect of that element, Festo does not apply.
`
`See, e.g., Regents v. DakoCytomation Cal., 517 F.3d 1364, 1378 (Fed. Cir. 2008);
`
`Microstrategy, Inc. v. Business Object, S.A., 331 F. Supp. 2d 432, 444 (E.D. Va. 2004).
`
`IL BOSTON IS UNLIKELY TO PROVE THAT ALL INFRINGED CLAIMS
`ARE INVALID
`
`Boston understates its burden in arguing VSI must prove a "clear case" of validity.
`
`Opp. at 18. A "patent enjoys the same presumption of validity during preliminary
`
`injunction proceedings as at other stages of litigation." Titan Tire Corp. v. Case New
`
`Holland, Inc., 566 F.3d 1372, 1377 (Fed. Cir. 2009). "[T]he burden is on the challenger
`
`to come forward with evidence of invalidity, just as it would be at trial." Id.; see also
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1359 (Fed. Cir. 2001).
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`In assessing VSI's likelihood of success, the Court must consider Boston's burden
`
`at trial. Titan Tire, 566 F.3d at 1380. Ultimately, the Court "must determine whether it is
`
`more likely than not that [Boston] will be able to prove at trial, by clear and convincing
`
`evidence, that the patent is invalid." Id. at 1379.
`
`While VSI believes the asserted claims will withstand all of Boston's invalidity
`
`attacks, for this motion VSI focuses on '032 patent claims 3, 4, 8, 13, and 17; '413 patent
`
`claims 4, 9, 10, and 13; and '850 patent claims 3, 4, 8, 14 and 18. For most of these
`
`claims, Boston concedes that Adams does not disclose all limitations, and therefore relies
`
`on facially weak obviousness arguments cobbled together from unrelated patents. But
`
`Boston's expert Vrba admits these combinations do not meet the threshold obviousness
`
`requirement, because they do not disclose all elements of the claims. Even if they did,
`
`Vrba's conclusory analysis is far from sufficient to establish that Boston is likely to prove
`
`a clear and convincing obviousness defense at trial.
`
`A. VSI Invented a Collar Adams Never Considered
`
`1. Adams Patent
`
`Boston bases its invalidity defense on Adams, an expired patent Boston owns but
`
`never commercialized. Adams discloses a flexible tube directly attached to a pushrod. In
`
`use, the tube's distal end extends out of the guide catheter, to provide "relatively easy and
`
`accurate exchanges of 'non-over-the-wire' catheters, guide wires and other coronary
`
`treatment devices," 4:41-44, "a conduit for drug delivery," 3:7-8, and for "aspirating
`
`thrombus from a coronary vessel," 3:19. Stensland Ex. 1.
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`Adams describes two types of direct connections between the tube and pushrod: a
`
`funnel and a balloon. The funnel is shown in these Adams figures:3
`
`Guide Catheter
`
`Balloon Catheter's
`Lumen
`
`Funnel
`
`Tube Inner
`Diameter
`
`Guide Catheter Inner
`Diameter
`
`Excerpt from Fig. 2
`
`3 All labels have been added to the figures.
`
`9
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`Using a funnel necessarily causes the flexible tube's diameter to be substantially
`
`smaller than the guide catheter's, as shown above. The funnel has a "close fit" with the
`
`guide catheter; this "close tolerance provides a seal to facilitate the flow of liquids (such
`
`as dye and drugs) through the guide catheter and the tube," 16:7-8. Stensland Ex. 1.
`
`Adams's other connection uses a balloon mounted at the flexible tube's proximal
`
`end. When inflated, the balloon seals the tube's end to the guide catheter's inside to
`
`allow fluid injections or aspiration, as shown in this excerpt from Figure 3:
`
`Guide Catheter
`
`Annular
`Balloon
`(Inflated)
`
`Balloon Catheter's
`Lumen
`
`Lumen Pushrod
`
`Figure 4 is a cross-section of the balloon concept, showing that the flexible tube's lumen
`
`is substantially smaller than the guide catheter's:
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`IPR2020-00131
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`

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`Guide Catheter's Lumen
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`.0"
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`gto.4
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`:rook
`ii
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`/75
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`171
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`In both connection designs, Adams discloses a flexible tube opening perpendicular
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`-to the guide catheter's axis. Both designs lack any "side opening."
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`Adams acknowledges problems in delivering the device, stating that it must be
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`inserted into the guide catheter concurrently with another device, or over an already-
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`inserted balloon catheter. Stensland Ex. 1 at 16:16-17. While Adams blames the
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`problem on the flexibility of its tube, id. at 2:58-62, it is the direct connection between
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`the flexible tube and pushrod and lack of collar that impede delivery. Second Root ¶ 17.
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`Thus, when Boston created Guidezilla, it copied GuideLiner's side opening collar instead
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`of Adams' funnel or balloon concept.
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`2. VSI's Innovative Collar
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`VSI's patents solve Adams' problems, both for delivery of interventional
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`cardiology devices and pushability, with an innovative collar that transitions between the
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`pushrod and flexible tube. VSI's collar has a side opening allowing for easy entry of
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`devices and effectively transmitting force from pushrod to tube, so that the tube can be
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`readily inserted through the guide catheter. VSI's collar is shown in VSI's patent
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`drawing below, and from photos of GuideLiner and Guidezilla:
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`U.S. Patent
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`Nov. 1, 2011
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`Shoot 4 013
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`t;S 8.048,032 112
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`28-1 L-30
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`GuideLiner VI Collar
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`Guidezilla Collar
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`B. Boston's Prior Art Does Not Disclose All Elements
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`Every claim limitation must be present in the prior art combination before the
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`obviousness analysis proceeds. Abbott Labs. v. Sandoz, Inc., 500 F. Supp. 2d 846, 852
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`(N.D. Ill. 2007), aff'd 544 F.3d 1341, 1351 (Fed. Cir. 2009); Lifescan, Inc. v. Shasta
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`Techs., LLC, --- F. Supp. 2d ,2013 WL 1149827, *11 (N.D. Cal. Mar. 19, 2013).
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`Boston's prior art is missing at least two key elements of VSI's invention, leaving
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`fourteen claims for which Boston has no colorable invalidity defense.
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`Boston's Prior Art Does Not Disclose A Tube "Not More Than
`One French Smaller" Than The Guide Catheter
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`Adams does not teach a tubular portion "not more than one French smaller" than
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`the guide catheter. Second Root VII 12-13, 23-25. Boston relies solely on the Adams tube
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`being smaller than the guide catheter; Vrba admits that no Adams embodiment discloses
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`the "one French" limitation. Redmond Ex. E at 59. Because both the funnel and balloon
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`versions require space between the guide catheter and the flexible tube, the Adams tube is
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`necessarily more than one French smaller than the guide catheter. Second Root ¶ 23.
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`Boston makes no argument that other prior art discloses the element. Boston is not likely
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`to prevail at trial on its invalidity defense as to '032 patent claims 8 and 17, '413 patent
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`claim 13, or '850 patent claims 8 and 18.
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`2. Boston's Prior Art Does Not Disclose VSI's Collar
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`Multiple VSI claims recite a side opening "adapted to receive" an interventional
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`cardiology device while the device is inside the guide catheter. E.g., Root Ex. 2, claim 13
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`("substantially rigid portion further includes a partially cylindrical portion defining an
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`opening extending for a distance along a side thereof. . . adapted to receive an
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`interventional cardiology device passed through the continuous lumen of the guide
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`catheter and into the coaxial lumen while the device is inserted into the continuous
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`lumen"). Vrba admits that Adams does not disclose a side opening for receipt of
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`interventional devices. Redmond Ex. E at 75. Boston asserts, however, that VSI's
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`claims are "obvious" in light of three references: Alt, Steinke, and Verbeek.
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`Alt, Steinke, and Verbeek disclose rapid exchange balloon catheters. A physician
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`threads the catheter's distal tip over a guidewire, outside the body. As the physician
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`slides the catheter over the guidewire, the guidewire exits the guidewire lumen, id. at 85,
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`87-88, 92, 97-98, while still outside the body. The physician then pushes the catheter
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`into the artery. The guidewire is typically 0.014 inches, and the guidewire lumen is 0.016
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`or 0.017 inches. Id. at 84. The figures below show Alt and Verbeek, as well as the ports
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`that Vrba claims function as a side opening for receiving interventional devices while
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`deep inside a guide catheter:
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`I Guidewire Exits Balloon Catheter
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`7 ,
`-41
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`23 8
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`-7
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`Alt Figure 1
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`Guidewire Enters
`at Distal Tip
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`70
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`Steinke's depiction (Figure 1) is similar to Alt's.
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`Verbeek Figures 1B, 1C
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`Boston argues that the angled exit ports on these balloon catheters teach the side
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`opening limitations in VSI's patents. However, the references disclose nothing more than
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`sloped exit ports on balloon catheters, all of which are quite different in design, function
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`and utility from VSI's invention.
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`The prior art ports are used for a guidewire to exit a balloon catheter, not as an
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`entrance for anything. Redmond Ex. E at 88, 98. Even if the exits were used as
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`entrances, none could possibly be used to insert a device when the balloon catheter is
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`inside a guide catheter, which is the purpose of VSI's guide extension collar. As Vrba
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`admits, the opening of the guidewire exit port is too small to accommodate any
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`interventional cardiology device (e.g., stent or balloon catheter). Id. at 88, 95-96, 99-100.
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`And even if a device were small enough, it would be impossible to insert it into a
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`guidewire exit port when the port is inside a guide catheter, because the port is only large
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`enough to accommodate a guidewire. Id. Using Verbeek's exit as an entrance would be
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`akin to threading a needle at the end of a 100cm tube in the dark; the Alt and Steinke
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`notches would add even more difficulty, requiring a sharp turn to enter the eye of the
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`needle. See Second Root IN 27-42.
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`Thus, the prior art exit ports are not side openings as claimed in VSI's patents —
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`they are not:
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`• part of a "substantially rigid portion [that] includes a partially cylindrical
`portion,"
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`• "accessible from a longitudinal side," and
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`• suitable "to receive an interventional cardiology device" while the opening
`remains in the guide catheter.
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`Even in combination, Boston's prior art does not disclose all elements of '032 patent
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`claims 3, 4 and 13, '413 patent claims 4, 9, and 10, or '850 patent claims 3, 4 and 14.
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`C. Hindsight Cannot Be Used To Combine Prior Art References
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`Even if Boston could identify the missing elements somewhere in the prior art, it
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`still did not make even a minimal showing of obviousness. Even defending against a
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`preliminary injunction, Boston must articulate why one of ordinary skill would have been
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`motivated to combine the prior art teachings to achieve the claimed invention, and why
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`the person of ordinary skill would have reasonably expected success in doing so. See
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`Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed. Cir. 2012).
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`Vrba's say-so is Boston's sole support for a motivation to combine Adams with
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`Alt, Steinke, or Verbeek. But Vrba appears to be little more than a mouthpiece for
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`Boston's lawyers and made no real analysis of the issue. Boston's lawyers selected the
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`references for him, presumably because each depicts a slanted opening in a catheter, and
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`he read only the portions to which he was directed. Redmond Ex. E at 15-18, 81.
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`Boston's obviousness defense is an extreme case of using hindsight to try to
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`recreate a patented invention. Boston's lawyers improperly "started with the patented
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`invention and then reached back to the prior art seeking out any reference that touched on
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`the individual elements" comprising VSI's invention. Lifescan, 2013 WL 1149827, *16;
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`see also Kinetic Concepts, 688 F.3d at 1368. There is no reason why one of ordinary
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`skill would have thought to take a sloped exit port from Alt, Steinke, or Verbeek, convert
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`that exit port into an entrance collar, modify it so it meets all of the claim limitations, and
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`use it to replace the perpendicular direct connection between the pushrod and flexible
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`tube taught in Adams. No prior art describes VSI's collar, or even any benefit of the
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`sloped exit port to improve the entrance of a device into the lumen, to reduce the
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`obstruction in the lumen, or to improve the catheter's pushability — exactly the benefits of
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`VSI's collar invention.
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`The Adams inventors knew their device had problems, but were unaware of the
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`cause or solution. Rapid exchange catheters and sloped openings were known long
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`before Adams — if such knowledge presented an obvious solution to Adams' problems,
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`presumably Adams would have disclosed the solution. He did not, and the problem
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`remained until VSI solved it. Second Root ¶ 39. Adams taught that the tube's excessive
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`flexibility caused the device's pushability problems, Stensland Ex. 1 at 2:58-62, 14:58-
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`62; thus, one of ordinary skill would not appreciate or try to solve the problem by
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`developing a new collar. Adams' focus on flexibility would lead one of ordinary skill in
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`the wrong direction. The strongest practical evidence of that fact is that Boston acquired
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`the Adams patent many years ago, but failed to commercialize a device until VSI solved
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`the problem years later. At that point, Boston simply copied VSI's solution.
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`D. Secondary Considerations
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`An obviousness determination must also take into account "secondary
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`considerations" or objective indicia of nonobviousness — e.g., unexpected results,
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`copying, commercial success, praise by others, failure by others, and long-felt need —
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`which are often the most probative evidence of nonobviousness and help inoculate the
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`obviousness analysis against hindsight. See Mintz v. Dietz & Watson, Inc., 679 F.3d
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`1372, 1378 (Fed. Cir. 2012); see also Kinetic Co