throbber
BSC USP 8,142,413
`Exhibit 1028
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`Page 1 of 27
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`Case: 14-1185 Document: 14-1 Page: 1 Filed: 01/03/2014
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`IN THE UNITED STATES COURT OF APPEALS
`FOR THE FEDERAL CIRCUIT
`
`
`
`
`
`
`No. 2014-1185
`
`
`
`
`
`
`
`Vascular Solutions, Inc.,
`
`Plaintiff-Appellee,
`
`v.
`
`Boston Scientific Corporation,
`
`
`
`
`
`Defendant-Appellant.
`
`
`On Appeal from the United States District Court
`For the District of Minnesota
`The Honorable Judge John R. Tunheim
`District Court No. 13-1172
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`
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`PLAINTIFF-APPELLEE VASCULAR SOLUTIONS, INC.’S
`OPPOSITION TO DEFENDANT-APPELLANT’S MOTION FOR AN
`INTERIM STAY AND STAY PENDING APPEAL
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`
`
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`
`
`Dorsey & Whitney LLP
`J. Thomas Vitt
`Heather D. Redmond
`Suite 1500, 50 South Sixth Street
`Minneapolis, MN 55402-1498
`Telephone: (612) 340-2600
`
`Attorneys for Plaintiff-Appellee
`Vascular Solutions, Inc.
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`Page 2 of 27
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`CERTIFICATE OF INTEREST
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`Counsel for Plaintiff-Appellee Vascular Solutions, Inc. certifies the
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`following:
`
`1.
`
`The full name of every party or amicus represented by me is:
`
`Vascular Solutions, Inc.
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`The name of the real party in interest (if the party named in the
`2.
`caption is not the real party in interest) represented by me is:
`
`Vascular Solutions, Inc.
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`All parent corporations and any publicly held companies that own 10
`3.
`percent or more of the stock of the party of amicus curiae represented by me are:
`
`Vascular Solutions, Inc. is a publicly traded corporation; it has
`no parent corporation; and no publicly held company owns
`more than 10% of its stock.
`
`The names of all law firms and the partners or associates that
`4.
`appeared for the party or amicus now represented by me in the trial court or agency
`or are expected to appear in this court are:
`
`J. Thomas Vitt
`Heather D. Redmond
`Shannon L. Bjorklund
`Forrest Tahdooahnippah
`
`Dorsey & Whitney LLP
`50 South Sixth Street, Suite 1500
`Minneapolis, MN 55402-1498
`Telephone: (612) 340-2600
`Facsimile: (612) 340-2868
`
`
`
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`

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`Page 3 of 27
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`Case: 14-1185 Document: 14-1 Page: 3 Filed: 01/03/2014
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`Dated: January 3, 2014
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`Respectfully submitted,
`
`DORSEY & WHITNEY LLP
`
`
`By /s/ Heather D. Redmond
`J. Thomas Vitt
`Heather D. Redmond
`50 South Sixth Street, Suite 1500
`Minneapolis, MN 55402-1498
`Telephone: (612) 340-2600
`
`Attorneys for Plaintiff-Appellee Vascular
`Solutions, Inc.
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`
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`

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`Page 4 of 27
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`Case: 14-1185 Document: 14-1 Page: 4 Filed: 01/03/2014
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`TABLE OF CONTENTS
`
`
`I.
`
`
`BSC HAS MADE NO SHOWING OF IRREPARABLE
`HARM ........................................................................................... 7
`
`II. VSI IS SUFFERING SUBSTANTIAL IRREPARABLE
`
`HARM AS A RESULT OF BSC’S INFRINGEMENT ............... 9
`
`III. BSC HAS NOT ESTABLISHED THAT IT HAS A
`
`STRONG LIKELIHOOD OF SUCCESS ON THE
`
`MERITS OF ITS APPEAL ......................................................... 10
`
`CERTIFICATE OF INTEREST
`
`TABLE OF AUTHORITIES ............................................................................. ii
`
`INTRODUCTION ............................................................................................. 1
`
`BACKGROUND ............................................................................................... 2
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`ARGUMENT ..................................................................................................... 6
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`CONCLUSION ................................................................................................ 19
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`
`
`
`
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`
`
`A.
`
`The District Court’s Claim Construction Is Correct ......... 11
`
`B.
`
`
`The District Court Correctly Rejected BSC’S
`Validity Challenge ............................................................ 13
`
`IV. BSC HAS NOT ESTABLISHED THAT A STAY IS IN
`
`THE PUBLIC INTEREST .......................................................... 18
`
`i
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`

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`
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`CASES
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`3M Innovative Properties Co. v. Avery Dennison Corp.,
`350 F.3d 1365 (Fed. Cir. 2003) .......................................................................... 18
`
`Abbot Labs. v. Sandoz, Inc.,
`500 F.Supp.2d 846 (N.D. Ill. 2007), aff’d 544 F.3d 1341 (Fed. Cir. 2009) ....... 15
`
`Am. Standard, Inc. v. Pfizer, Inc.,
`828 F.2d 734 (Fed. Cir. 1987) ............................................................................ 17
`
`Apple, Inc. v. Samsung Elecs. Co.,
`678 F.3d 1314 (Fed. Cir. 2012) .......................................................................... 10
`
`Apple, Inc. v. Samsung Elecs. Co.,
`695 F.3d 1370 (Fed. Cir. 2012) ...................................................................... 9, 10
`
`Emenaker v. Peake,
`551 F.3d 1332 (Fed. Cir. 2008) .......................................................................... 17
`
`Fresenius USA, Inc. v. Baxter Int’l, Inc.,
`582 F.3d 1288 (Fed. Cir. 2009) .......................................................................... 17
`
`Hilton v. Braunskill,
`481 U.S. 770 (1987) .......................................................................................... 7, 9
`
`J.T. Eaton & Co. v. Atl. Paste & Glue Co.,
`106 F.3d 1563 (Fed. Cir. 1997) .......................................................................... 16
`
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) .......................................................................... 16
`
`Merial Ltd. v. Cipla Ltd.,
`426 F. App’x 915 (Fed. Cir. 2011) ..................................................................... 10
`
`Nken v. Holder,
`556 U.S. 418 (2009) .............................................................................................. 6
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .......................................................... 11
`
`ii
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`Sanifo-Synthelabso v. Apotex, Inc.,
`470 F.3d 1368 (Fed. Cir. 2006) ............................................................................ 8
`
`Standard Havens Prods., Inc. v. Gencor Indus., Inc.,
`897 F.2d 511 (Fed. Cir. 1990) .............................................................................. 7
`
`Teva Pharms.USA, Inc. v. Sandoz, Inc.,
`723 F.3d 1363 (Fed. Cir. 2013) .......................................................................... 16
`
`Windsurfing Int’l, Inc. v. AMF, Inc.,
`782 F.2d 995 (Fed. Cir. 1986) .............................................................................. 8
`
`
`
`iii
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`

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`Page 7 of 27
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`INTRODUCTION
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`Appellee Vascular Solutions, Inc. (“VSI”) respectfully requests that the
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`Court deny Appellant Boston Scientific Corporation’s (“BSC”) motion for a stay
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`of the district court’s December 9, 2013 Preliminary Injunction Order (Add. B).1
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`BSC’s Guidezilla device infringes multiple claims of three VSI patents, and
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`is a nearly-exact copy of VSI’s GuideLiner guide extension catheter. GuideLiner
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`is VSI’s flagship product, critical to VSI’s continued success, and BSC’s
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`infringement is irreparably harming VSI. By contrast, BSC made no showing
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`below, and no real argument here, that it will suffer any significant harm from the
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`injunction. BSC also cannot show that it has a strong likelihood of success on
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`appeal. The weakness of BSC’s arguments is highlighted by its apparent belief
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`that every decision in the district court’s carefully-reasoned, 41-page opinion was
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`in error. In fact, the district court correctly enjoined BSC’s infringement to protect
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`VSI from further harm. The Court should deny BSC’s stay motion and allow the
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`district court’s order to take effect on January 13, 2014.
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`
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`
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`1 “Add. B” references the Addendum to Appellant’s Motion. Numbered exhibits
`1-24 were attached to the Declaration of Seth I. Heller, submitted with
`Appellant’s motion. Lettered exhibits A-AA are attached to the Declaration of
`Heather D. Redmond, submitted herewith.
`
`1
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`

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`Page 8 of 27
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`BACKGROUND
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`VSI introduced GuideLiner in 2009, after years of development. GuideLiner
`
`consists of a flexible, tubular portion with a lumen, a substantially rigid portion
`
`(referred to as a pushrod), and a transitional collar section between the flexible
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`portion and the pushrod. Doctors use GuideLiner in interventional cardiology
`
`procedures. GuideLiner’s flexible portion is inserted through the distal end of the
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`guide catheter so that the flexible portion’s distal portion is “deep-seated” in the
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`coronary artery. GuideLiner provides backup support to prevent dislodging of the
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`guide catheter, and allows doctors to access and treat hard-to-reach lesions in
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`diseased arteries. See Redmond Ex. A ¶¶ 21-29.
`
`VSI’s GuideLiner was the first commercial device to combine guide catheter
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`extension with the ease of monorail delivery (also called rapid exchange).
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`Id. ¶¶ 21, 107. Before BSC’s copycat product, GuideLiner was the only device of
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`its kind in the world. Id. ¶ 107. Doctors praise GuideLiner as a “game-changer”
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`making previously impossible cases possible. Id. ¶ 44-45. GuideLiner has been a
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`huge success for VSI, with rapidly growing sales that now make up 20% of VSI’s
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`total, and providing VSI visibility and access to new customers. Id. ¶¶ 39-42.
`
`VSI obtained three U.S. patents to protect GuideLiner’s exclusive market
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`position: No. 8,048,032 on the device, No. 8,142,413 on methods for using the
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`device, and No. 8,292,850, on a system comprised of the device in combination
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`2
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`

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`Page 9 of 27
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`with a guide catheter. Redmond Exs. B-D. The ‘032 patent, discussed in the
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`district court’s opinion, has independent claims broadly claiming the flexible
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`tubular portion and the substantially rigid portion, and dependent claims adding
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`limitations covering the transitional collar shapes and the collar’s ability to receive
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`interventional devices while inside the guide catheter.
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`Claim 3 of the ‘032 patent claims the collar by adding to claims 1 and 2 “the
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`proximal portion of the tubular structure further comprises structure defining a
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`proximal side opening . . . to receive an interventional cardiology device in the
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`coaxial lumen while the proximal portion remains within the lumen of the guide
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`catheter.” Dependent claim 4 further modifies claim 3 by adding “wherein the
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`proximal side opening includes structure defining a full circumference portion and
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`structure defining a partially cylindrical portion.” Dependent claim 13 depends
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`from claim 11, adding “the substantially rigid portion further includes a partially
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`cylindrical portion defining an opening . . . that is adapted to receive an
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`interventional cardiology device . . . while the device is inserted into the
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`continuous lumen” of the guide catheter. Redmond Ex. B. Dependent claims 3, 4,
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`and 14 of the ‘850 system patent are similar to the ‘032 dependent claims.
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`Redmond Ex. D. Dependent claims 4, 9, and 10 of the ‘413 method patent are
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`worded somewhat differently, but add to the independent claims the requirement of
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`using a “side opening” and “extending the interventional cardiology device
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`3
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`

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`Page 10 of 27
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`through a proximal side opening . . . while the proximal portion remains within the
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`lumen of the guide catheter.” Redmond Ex. C.
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`VSI heard rumors that BSC was developing a competing product, and in
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`October, 2012 VSI’s CEO, Howard Root, sent copies of the GuideLiner patents to
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`BSC. Redmond Ex. A ¶ 52. BSC did not substantively respond. VSI was
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`naturally concerned; BSC has $7 billion in annual sales, 70 times VSI’s sales, and
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`has the largest market share for U.S. interventional cardiology devices. Id. ¶¶ 46-
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`48. In April, 2013, VSI learned that BSC was testing Guidezilla on a patient. VSI
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`wrote BSC again, asking for a sample and for any analysis that BSC had performed
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`with respect to VSI’s patents. Id. ¶ 59-60. BSC again did not respond. In May,
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`2013, VSI obtained a sample Guidezilla device from another source. VSI
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`confirmed that Guidezilla infringed multiple claims of VSI’s patents, and indeed
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`was clearly a copy of VSI’s GuideLiner device, and filed suit. Id. ¶¶ 61, 68-87;
`
`Redmond Ex. N.
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`After conferring with BSC as required by local rule, VSI filed its
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`preliminary injunction motion on June 10. During the meet and confer process,
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`BSC raised only one defense: that Guidezilla does not have a “substantially rigid
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`portion . . . defining a rail structure without a lumen.” Redmond Exs. O, T ¶¶ 7-9.
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`BSC did not raise any invalidity defense or mention the Adams patent (which BSC
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`4
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`owns). VSI had no knowledge of Adams until BSC showed it to Mr. Root at his
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`deposition on June 27. Redmond Ex. R ¶ 3.
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`Contrary to BSC’s motion, BSC had a full and fair opportunity to litigate its
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`validity challenge to all of VSI’s asserted claims, and in fact did so. VSI’s opening
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`brief alleged infringement of 43 claims. VSI’s inventor, Howard Root, provided
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`detailed claim charts explaining the infringement of each claim, including the
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`dependent claims relied on by the district court.2 Redmond Ex. N. VSI
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`specifically noted that BSC would have to show that it was more likely than not
`
`that each asserted claim was invalid. Heller Ex. 3 at 29.
`
`In response, BSC argued that all of VSI’s claims were invalid, relying on a
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`declaration from a former BSC employee, Anthony Vrba. BSC conceded that
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`Adams did not disclose the collar limitations of dependent claims 3, 4, and 13 of
`
`the ‘032 patent, claims 4, 9, and 10 of the ‘413 patent, and claims 3, 4, and 14 of
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`the ‘850 patent. BSC’s lawyers provided Vrba with three secondary references,
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`Alt, Steinke, and Verbeek, pointing out to him that each of those patents showed an
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`angled opening. Vrba read only the portions of the patents that BSC’s lawyers
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`identified for him, and argued that Adams combined with Alt, Steinke, or Verbeek
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`rendered the dependent claims obvious. Redmond Ex. V at 15-18, 81.
`
`
`2 BSC’s attack on Root’s qualifications is not well-founded. Mr. Root has 16
`years of experience inventing medical devices, has been personally involved in
`the development of VSI’s products, and is the named inventor on 10 VSI
`patents. Redmond Ex. A ¶ 2.
`
`5
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`

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`Page 12 of 27
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`VSI chose to focus on the dependent collar claims in its reply, because in
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`VSI’s view infringement was clear and BSC had not made a legitimate validity
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`challenge to those claims. VSI’s reply and Mr. Root’s second declaration, filed
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`July 24, explained why Alt, Steinke, and Verbeek did not disclose the dependent
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`claim elements, and why the district court should not make a preliminary finding
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`that those claims were likely to be ruled obvious at trial. Redmond Ex. R ¶¶ 2-42;
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`Ex. AA at 7-17.
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`At the August 27 hearing, BSC attempted to make a new argument based on
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`the Klein patent. The Klein patent was not discussed in BSC’s brief or the Vrba
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`declaration, and BSC did not make Klein part of the district court record. The
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`court issued its order on December 9, 2013. BSC filed a letter requesting leave to
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`file a motion for reconsideration on December 12, arguing that the combination of
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`Adams with Klein would invalidate the collar claims relied on by the court. Heller
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`Ex. 9. BSC again did not make the Klein patent part of the record. The district
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`court denied BSC’s motion for leave on December 23, and this appeal followed.
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`ARGUMENT
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`“A stay is an ‘intrusion into the ordinary processes of administration and
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`judicial review,’ and accordingly ‘is not a matter of right, even if irreparable injury
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`might otherwise result.’” Nken v. Holder, 556 U.S. 418, 427 (2009) (citations
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`omitted). BSC has the burden to establish that it would suffer irreparable harm
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`6
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`

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`Page 13 of 27
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`absent the stay, that VSI would not be substantially harmed by the stay, that BSC
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`has a strong likelihood of success on appeal, and that a stay is in the public interest.
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`Hilton v. Braunskill, 481 U.S. 770, 776 (1987). BSC’s motion falls far short of
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`establishing any of these requirements.
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`I. BSC HAS MADE NO SHOWING OF IRREPARABLE HARM
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`BSC must submit record evidence establishing that its “reasonably expected
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`harm would be both catastrophic and irreparable.” Standard Havens Prods., Inc.
`
`v. Gencor Indus., Inc., 897 F.2d 511, 516 (Fed. Cir. 1990) (emphasis added).
`
`BSC does not even attempt to assert that it will suffer catastrophic,
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`irreparable harm from the injunction. Instead, it claims only “potential” “hardship”
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`from layoffs, lost inventory, and damage to customer relationships, citing a single
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`paragraph in the declaration of its product manager Sam Rasmusen. BSC Mot. at
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`20. The district court already considered and rejected identical arguments.
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`Rasmusen’s deposition testimony, taken after his declaration, severely undercuts
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`BSC’s hardship claim. See Redmond Ex. AA at 19. Rasmusen testified that, in
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`preparation for product launch, BSC conducted less than three hours of sales
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`training; that no product development, regulatory approval, quality control, or
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`packaging work would be lost; and that he had no idea if any employees would
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`actually be let go or reassigned. Redmond Ex. Y at 83-100. Rasmusen’s
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`7
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`declaration regarding customer relationships was limited to the small number of
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`Guidezilla customers of which he was aware at the time. Id. at 101.
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`Even if BSC had established a realistic expectation of some harm, there is no
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`plausible evidence that such harm would have any real impact on BSC, much less a
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`catastrophic one. BSC is the largest medical device company in the U.S. market
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`for interventional cardiology devices, with a 40% market share in 2010. Redmond
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`Ex. A at ¶ 48. Guidezilla is (and will always be) an insignificant portion of BSC’s
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`$7.2 billion annual revenue. Id. ¶¶ 46-48.
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`Any potential harm to BSC is a consequence of its own actions. BSC failed
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`to heed multiple warnings – the first delivered by VSI eight months before BSC’s
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`June 2013 Guidezilla launch. Redmond Ex. A ¶¶ 51-52, 59-60; Ex. I. The district
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`court correctly noted that the cost of designing and marketing an infringing product
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`does not support a finding of harm to BSC. Add. B at 38. “One who elects to
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`build a business on a product found to infringe cannot be heard to complain if an
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`injunction against continuing infringement destroys the business so elected.”
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`Windsurfing Int’l, Inc. v. AMF, Inc., 782 F.2d 995, 1003 n.12 (Fed. Cir. 1986). See
`
`also, Sanifo-Synthelabso v. Apotex, Inc., 470 F.3d 1368, 1383 (Fed. Cir. 2006).
`
`Finally, BSC’s assertion that the bond is insufficient should be rejected
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`outright. BSC never suggested, much less proved, a more satisfactory amount to
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`the district court, and did not do so here.
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`8
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`II. VSI IS SUFFERING SUBSTANTIAL IRREPARABLE HARM AS A
`RESULT OF BSC’S INFRINGEMENT
`
`When a large company like BSC combines a nearly identical product with
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`its greater resources to compete against a smaller company’s patented flagship
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`product, irreparable harm inevitably will result. VSI submitted to the district court
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`a detailed evaluation of likely harm, supported by past examples, by Boston’s own
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`actions in the marketplace, and by legal precedent. Heller Ex. 3 at 15-18, 29-33;
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`Redmond Ex. A ¶¶ 107-30. The court found actual evidence of price erosion and
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`lost sales to BSC, that the patented technology is “central to” VSI’s business, and
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`that “the harm to [VSI] in the absence of an injunction is likely to be greater than
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`that caused to [BSC] by an injunction.” Add. B at 37, 39.
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`BSC does not contest the district court’s finding that BSC’s continuing
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`infringement is causing substantial irreparable harm to VSI. Indeed, BSC devotes
`
`just one sentence of its brief to the issue, making the unsupported claim that VSI’s
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`harm will be easier to calculate. Even if BSC had made some effort to prove the
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`assertion, it would be insufficient to establish that VSI will “not be substantially
`
`harmed if a stay were granted.” Hilton, 481 U.S. at 776.
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`Finally, BSC incorrectly asserts that VSI must show that its harm is caused
`
`by BSC’s infringement of some specific, novel feature of the patents. BSC Mot. at
`
`19. That aspect of the Apple, Inc. v. Samsung Elecs. Co., 695 F.3d 1370 (Fed. Cir.
`
`2012) holding is expressly limited to cases “where the accused product includes
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`9
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`many features of which only one (or a small minority) infringe.” Apple, 695 F.3d
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`at 1374. Here, GuideLiner is the patented invention, and Guidezilla is a nearly
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`exact copy of it; this is not a case where the patent covers only one aspect of a
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`larger device, and there is doubt about which features are driving product sales. In
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`any event, VSI submitted substantial evidence of accolades and clinical studies
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`establishing the clinical benefits of GuideLiner, including the collar, as well as
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`testimony establishing that those benefits – copied by BSC – and VSI’s growing
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`product sales are tied to GuideLiner’s patented design. Redmond Ex. A ¶¶ 21-36,
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`39-45; Exs. E-H, S; Ex. R ¶¶ 5, 18-22. This fact is further demonstrated by the
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`lack of competitive devices on the market, with the only recent exception being
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`BSC’s copycat Guidezilla device. Redmond Ex. A ¶ 107. BSC should not be
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`allowed to continue to irreparably harm VSI during the appeal.
`
`III. BSC HAS NOT ESTABLISHED THAT IT HAS A STRONG
`LIKELIHOOD OF SUCCESS ON THE MERITS OF ITS APPEAL
`
`In addition to showing its own irreparable harm and an absence of harm to
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`VSI, BSC must show that the district court’s decision on the merits was so clearly
`
`wrong that BSC has a “strong likelihood of success on the merits.” Merial Ltd. v.
`
`Cipla Ltd., 426 F. App’x 915, 915 (Fed. Cir. 2011). Because “the decision whether
`
`to issue a preliminary injunction is one that is committed to the discretion of the
`
`district court, . . . the appellant’s task in overturning that decision is a difficult
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`one.” Apple, Inc. v. Samsung Elecs. Co., 678 F.3d 1314, 1316 (Fed. Cir. 2012).
`
`10
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`BSC cannot show that it has a strong likelihood of demonstrating that the district
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`court abused its discretion in entering the preliminary injunction.
`
`A. The District Court’s Claim Construction Is Correct
`
`The district court thoroughly analyzed the construction of the claim element
`
`“a substantially rigid portion . . . defining a rail structure without a lumen,” and
`
`concluded that “a person having ordinary skill in the art of cardiac catheterization
`
`procedures / interventional cardiology would understand ‘lumen’ as used in the
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`phrase . . . to mean ‘a passageway through which interventional cardiology devices
`
`are insertable.’” Add. B at 30. In doing so, the court analyzed the claims, patent
`
`specification, and file history as required by Phillips v. AWH Corp., 415 F.3d 1303,
`
`1313-17 (Fed. Cir. 2005) (en banc) and correctly rejected BSC’s invitation to start
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`instead with extrinsic evidence divorced from the patents. Add. B at 26-30.
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`BSC invites this Court to make the same error, by ignoring the intrinsic
`
`evidence in favor of various dictionary definitions, the lawyer-supplied opinion of
`
`BSC’s “expert” Vrba, see Redmond Ex. V at 103, and a construction of “lumen”
`
`from a court decision relating to a different patent. BSC Mot. at 9-12. The district
`
`court correctly rejected the arguments, because they violate the Phillips claim
`
`construction principles and conflict with the intrinsic evidence relating to the
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`patents-in-suit. Add. B at 26-30. VSI submitted intrinsic evidence from the
`
`patents’ claim language and the patents’ specification. For example, the asserted
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`11
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`Page 18 of 27
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`Case: 14-1185 Document: 14-1 Page: 18 Filed: 01/03/2014
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`claims expressly and consistently use “lumen” to refer to a space that allows an
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`interventional cardiology device to pass, to reach the artery. E.g., Redmond Ex. B,
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`claim 1; Ex. C, claim 1. The common specification also consistently uses “lumen”
`
`to refer to a passage through which interventional cardiology devices can pass, to
`
`reach the arterial site. E.g., Redmond Ex. B, col. 1:32-36; 4:2-4; 4:5-7; 6:60-61;
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`9:59-63. See also, Ex. AA at 2-4; Heller Ex. 3 at 23-24.
`
`By contrast, BSC submitted no intrinsic evidence to support its proposed
`
`construction. Instead, BSC simply attempts to undercut VSI’s evidence. For
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`example, BSC is wrong that the prosecution history supports its construction. BSC
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`Mot. at 12 n.4. During prosecution, the examiner rejected VSI’s claims in view of
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`prior art disclosing “a tubular structure [with a] lumen through which cardiology
`
`devices are insertable” and noted that nothing in Solar precludes a device large
`
`enough to receive an interventional cardiology device. Redmond Ex. W at 186,
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`192. If relevant at all, the statements support VSI’s construction. BSC is also
`
`wrong that use of the term “continuous” precludes VSI’s and the district court’s
`
`construction. BSC is asking the Court to construe a claim element not previously
`
`addressed by the district court, and if anything, the term is merely superfluous.
`
`Although not necessary, VSI also submitted substantial extrinsic evidence,
`
`including BSC’s internal and technical documents, multiple publications and
`
`patents in the relevant field, definitions from medical dictionaries, and the
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`12
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`Page 19 of 27
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`testimony of the patents’ inventor – all consistent with the intrinsic evidence and
`
`the district court’s construction. Redmond Ex. P. See also, Ex. AA at 4; Heller
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`Ex. 3 at 24-25.
`
`BSC also attempts a new argument on appeal – that the term “defining”
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`means that the substantially rigid portion can have no structure other than a rail
`
`structure without a lumen. BSC Mot. at 8-9. As an initial matter, BSC asks this
`
`Court to construe the term “defining” as a matter of first impression in this case –
`
`neither party submitted any evidence or argument regarding the meaning of
`
`“defining” to the district court. In addition, BSC’s construction would erase those
`
`claims of the patents requiring that the substantially rigid portion have both a rail
`
`structure without a lumen and a collar with a lumen. Redmond Ex. B, claim 13.
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`BSC has not demonstrated a strong likelihood that this Court will overturn
`
`the district court’s thoughtful claim construction on appeal.
`
`B.
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`The District Court Correctly Rejected BSC’S Validity Challenge
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`BSC argued below that the combinations of Adams with Alt, Steinke, or
`
`Verbeek make obvious the “collar” claims of VSI’s patents. BSC does not have a
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`strong likelihood of success on appeal of this issue. The district court carefully
`
`reviewed the legal standards, analyzed the facts, considered the actual claim
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`language, and correctly decided that VSI was likely to prevail. Add. B at 30-35.
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`13
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`Page 20 of 27
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`Case: 14-1185 Document: 14-1 Page: 20 Filed: 01/03/2014
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`BSC’s stay motion attempts to narrow the nine dependent claims as
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`“directed to one narrow limitation – an angled (or ‘skived’) side opening . . .”,
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`which BSC claims was “an obvious design choice.” BSC Mot. at 1, 13. But BSC
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`mischaracterizes the claim limitations. The collar limitations relate both to the
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`shape of the collar opening, claiming it as a “proximal side opening” or an opening
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`with a “full circumference portion” and a “partially cylindrical portion”, and to the
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`collar’s ability “to receive an interventional cardiology device into the coaxial
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`lumen while the proximal portion remains within the lumen of the guide catheter.”
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`See, e.g., Redmond Ex. B, claims 3, 4 and 13.
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`BSC’s motion also ignores fundamental flaws in its argument. First, Adams
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`does not disclose anything like the “collar” limitations – instead, the Adams
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`pushrod is connected directly to the flexible tube. Mr. Root explained in detail
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`why VSI’s patented collar made GuideLiner a superior device to the one described
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`in Adams. Redmond Ex. R ¶¶ 2-22. VSI’s collar transition provides superior
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`pushability, because it translates the force from the narrow pushrod to the full
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`circumference of the flexible tubular portion and thus makes GuideLiner easier to
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`advance. The collar also provides a smoother transition from pushrod to flexible
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`tube than Adams, so that GuideLiner is “adapted to receive” a stent or other
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`interventional cardiology device while inside the guide catheter, reducing the risk
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`that the stent will catch or dislodge. Id. ¶¶ 18-22. The collar’s advantages were
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`14
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`Page 21 of 27
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`Case: 14-1185 Document: 14-1 Page: 21 Filed: 01/03/2014
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`critical to GuideLiner’s success, id.; and Adams’s defects may explain why BSC
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`never commercialized the Adams device, choosing instead to copy VSI’s
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`GuideLiner and its collar. Indeed, the Adams patent itself admits the device has
`
`problems with lack of pushability. Heller Ex. 2, col. 2:58-62, 14:58-62, 16:16-28.
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`Second, BSC’s motion ignores that Alt, Steinke, and Verbeek do not
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`disclose the elements of the nine dependent collar claims. Alt, Steinke, and
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`Verbeek disclose angled exit ports sized for a guidewire. Each patent describes a
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`device used by threading the device’s distal tip over a guidewire, with the
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`guidewire exiting the exit port, outside the body. Mr. Root explained, and BSC’s
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`expert admitted, that it would be impossible to use these tiny exit ports to receive
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`an interventional cardiology device while the device was inside the lumen of a
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`guide catheter; a stent or balloon wouldn’t fit, and trying to thread a guidewire into
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`the exit ports while inside the guide catheter would be akin to threading a needle at
`
`the end of a 100cm tube in the dark. See Redmond Ex. R ¶¶ 27-42; Ex. V at 88,
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`95-100; Ex. AA at 13-15. Because BSC’s combinations do not disclose the
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`elements of the collar claims, BSC’s obviousness challenge fails. Abbot Labs. v.
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`Sandoz, Inc., 500 F.Supp.2d 846, 852 (N.D. Ill. 2007), aff’d 544 F.3d 1341, 1351
`
`(Fed. Cir. 2009).
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`Third, BSC’s obviousness appeal will fail because BSC did not present any
`
`evidence explaining why a person of ordinary skill would be motivated to combine
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`15
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`Page 22 of 27
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`Case: 14-1185 Document: 14-1 Page: 22 Filed: 01/03/2014
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`Adams with the secondary references to achieve the claimed inventions, and why
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`the person of ordinary skill would have reasonably expected success in doing so.
`
`See Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d 1342, 1360 (Fed.
`
`Cir. 2012). Instead, BSC engaged in a clumsy hindsight reconstruction. BSC’s
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`lawyers selected Alt, Steinke, and Verbeek for their expert, Vrba. Redmond Ex. V
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`at 15-18, 81. Vrba read only the portions of those references that the lawyers told
`
`him to read, and made no real analysis of the obviousness issue. Id. Vrba’s
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`conclusory assertion that a slanted opening is an “obvious design choice” is an
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`improper exercise in hindsight, as BSC’s lawyers improperly started with the
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`patented invention and then reached back to the prior art to try to find the missing
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`elements. Kinetic Concepts, 688 F.3d at 1360.
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`Fourth, the district court correctly relied on VSI’s powerful secondary
`
`considerations eviden

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