CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 1 of 40
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`UNITED STATES DISTRICT COURT
`DISTRICT OF MINNESOTA
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`Case No. 0:17-cv-01969 (PJS/TNL)
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`QXMédical, LLC,
`Plaintiff and Counterclaim
`Defendant,
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`v.
`Vascular Solutions LLC, Teleflex
`Innovations S.à.r.l., and Arrow
`International, Inc.,
`Defendants and Counterclaim
`Plaintiffs.
`
`DECLARATION OF PETER T. KEITH IN SUPPORT OF DEFENDANTS’
`OPPOSITION TO PLAINTIFF’S MOTION FOR SUMMARY JUDGMENT AND
`DEFENDANTS’ CROSS-MOTION FOR SUMMARY JUDGMENT
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`1
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`Page 1
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`IPR2020-01344
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`Medtronic Ex-1825
`Medtronic v. Teleflex
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 2 of 40
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`2. 
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`3. 
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`TABLE OF CONTENTS
`Introduction ..........................................................................................................................1 
`Overview of the VSI Patents ................................................................................................2 
`Infringement by the Boosting Catheter ................................................................................4 
`The Boosting Catheter Meets the “Without a Lumen” Limitation of the
`A. 
`’032, ’413, and ’380 Patents ....................................................................................5 
`The Boosting Catheter Infringes the ’776 Patent ...................................................10 
`The Boosting Catheter Meets the “Substantially Rigid Segment”
`1. 
`Limitation of the ’776 Patent Claims .........................................................12 
`QXM Directly Infringes the ’776 Patent’s “One French”
`Limitation ...................................................................................................13 
`The Boosting Catheter Meets The Claim Limitations Requiring
`The “Segment Defining A Side/Partially Cylindrical Opening” To
`Be More Rigid Than The Tubular Structure Or The Distal End
`Portion Of The Tubular Structure ..............................................................15 
`“Inclined Region that Tapers into a Non-Inclined Region” .......................23 
`4. 
`“At Least Two Inclined Regions” ..............................................................24 
`5. 
`Claim 53 of the ’116 Patent Is Not Anticipated by Adams ...............................................24 
`A. 
`Background on Adams ...........................................................................................24 
`B. 
`Adams Does Not Disclose “A Segment Defining A Side Opening” .....................27 
`C. 
`Rigidity Comparisons ............................................................................................28 
`Indefiniteness .....................................................................................................................29 
`Recapture ...........................................................................................................................34 
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`B. 
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`I. 
`II. 
`III. 
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`IV. 
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`V. 
`VI. 
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 3 of 40
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`I, Peter T. Keith, state as follows:
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`I.
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`INTRODUCTION
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 4 of 40
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`II.
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`OVERVIEW OF THE VSI PATENTS
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 6 of 40
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`III.
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`INFRINGEMENT BY THE BOOSTING CATHETER
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` Claims 3 and 8 of U.S. Patent No. 8,048,032 (the ’032 Patent, Doc. 8-1, Ex. H)
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` Claim 9 of U.S. Patent No. 8,142,413 (the ’413 Patent, Doc. 8-1, Ex. I)
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` Claims 1, 3, and 8 of U.S. Patent No. RE45,380 (the ’380 Patent, Doc. 8-1, Ex. D)
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` Claims 25, 30, 31, 32, and 48 of U.S. Patent No. RE45,760 (the ’760 Patent, Doc.
`8-1, Ex. E)
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` Claims 25, 32, 36, 52, and 53 of U.S. Patent No. RE45,776 (the ’776 Patent, Doc.
`8-1, Ex. F), and
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` Claims 25, 34, and 53 of U.S. Patent No. RE46,116 (the ’116 Patent, Doc. 8-1,
`Ex. G).
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 7 of 40
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`A.
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`The Boosting Catheter Meets the “Without a Lumen” Limitation of the ’032,
`’413, and ’380 Patents.
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`Q.
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`A.
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`Q.
`A.
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`At the end of the day when the final shaft is embedded into the strain relief
`and the handle, is there any access from the outside to that space that is
`inside the shaft?
`No.
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`If you wanted to put something through there, you couldn’t?
`Obviously not.
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 12 of 40
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`The Boosting Catheter Infringes the ’776 Patent
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`B.
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` Claim 25 of the ’776 patent:
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`25. A guide extension catheter for use with a guide catheter,
`comprising:
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` a
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` a
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` substantially rigid segment;
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` tubular structure defining a lumen and positioned distal to the
`substantially rigid segment; and
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 13 of 40
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` a
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` segment defining a partially cylindrical opening positioned
`between a distal end of the substantially rigid segment and a
`proximal end of the tubular structure, the segment defining the
`partially cylindrical opening having an angled proximal end,
`formed from a material more rigid than a material or material
`combination forming the tubular structure, and configured to
`receive one or more interventional cardiology devices therethrough
`when positioned within the guide catheter,
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`wherein a cross-section of the guide extension catheter at the
`proximal end of the tubular structure defines a single lumen.
`
` Claim 36 of the ’776 patent:
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`36. The guide extension catheter of claim 25, wherein the segment
`defining the angled proximal end of the partially cylindrical
`opening includes at least one inclined region that tapers into a
`non-inclined region.
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` 
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` 
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` Claim 52 of the ’776 patent:
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`52. A guide extension catheter for use with a guide catheter,
`comprising:
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` substantially rigid segment;
`
` a
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` a
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` tubular structure defining a lumen and positioned distal to the
`substantially rigid segment; and
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` a
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` segment defining a partially cylindrical opening positioned
`between a distal end of the substantially rigid segment and a
`proximal end of the tubular structure, the segment defining the
`partially cylindrical opening having an angled proximal end,
`formed from a material having a greater flexural modulus
`than a flexural modulus of the tubular structure, and
`configured to receive one or more interventional cardiology
`devices therethrough when positioned within the guide catheter,
`
`wherein a cross-section of the guide extension catheter at the
`proximal end of the tubular structure defines a single lumen;
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`wherein the segment defining the angled proximal end of the
`partially cylindrical opening includes at least two inclined
`regions.
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` Claim 53 of the ’776 patent:
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 14 of 40
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`53. A guide extension catheter for use with a guide catheter having
`a lumen with a cross-sectional inner diameter, comprising:
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` tubular structure defining a lumen and positioned distal to the
`substantially rigid segment, the lumen having a uniform cross-
`sectional inner diameter that is not more than one French size
`smaller than the cross-sectional inner diameter of the lumen of
`the guide catheter; and
`
` a
`
` segment defining a partially cylindrical opening positioned
`between a distal end of the substantially rigid segment and a
`proximal end of the tubular structure, the segment defining the
`partially cylindrical opening having an angled proximal end and
`configured to receive one or more interventional cardiology
`devices when positioned within the lumen of the guide catheter, a
`cross-section of the guide extension catheter at the proximal end of
`the tubular structure defining a single lumen;
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`wherein the segment defining the angled proximal end of the
`partially cylindrical opening includes at least two inclined
`regions.
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`1.
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`The Boosting Catheter Meets the “Substantially Rigid Segment”
`Limitation of the ’776 Patent Claims.
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` substantially rigid segment;
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 15 of 40
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`2.
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` QXM Directly Infringes the ’776 Patent’s “One French” Limitation
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`“the cross-sectional inner diameter of the coaxial lumen of the tubular structure is
`not more than one French smaller than the cross-sectional inner diameter of the
`guide catheter,” as recited in claim 8 of the ’032 patent and claim 8 of the ’380
`patent;
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`“the lumen of the tubular structure … having a uniform cross-sectional inner
`diameter that is not more than one French size smaller than the cross-sectional
`inner diameter of the lumen of the guide catheter,” as recited in claims 25 and
`claim 48 of the ’760 patent;
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`“a cross-sectional inner diameter of the lumen of the tubular structure is not more
`than one French size smaller than a cross-sectional inner diameter of a lumen of
`the guide catheter,” as recited in claim 30 of the ’776 patent;
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`“the tubular structure having a cross-sectional inner diameter that is not more than
`one French size smaller than a cross-sectional inner diameter of the lumen of the
`guide catheter,” as recited in claim 25 of the ’116 patent; and
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`“a tubular structure … having a uniform cross-sectional inner diameter that is not
`more than one French size smaller than the cross-sectional inner diameter of the
`lumen of the guide catheter,” as recited in claim 53 of the ‘776 patent.
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 16 of 40
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 17 of 40
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`3.
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`The Boosting Catheter Meets The Claim Limitations Requiring The
`“Segment Defining A Side/Partially Cylindrical Opening” To Be More
`Rigid Than The Tubular Structure Or The Distal End Portion Of The
`Tubular Structure.
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`“a material forming the segment defining the side opening is more rigid than the
`tubular structure,” as recited in claim 25 of the ʼ760 patent;
`“the segment defining the partially cylindrical opening … formed from a material
`more rigid than a material or material combination forming the tubular structure,”
`as recited in claim 25 of the ʼ776 patent;
`“the segment defining the partially cylindrical opening … formed from a material
`having a greater flexural modulus than a flexural modulus of the tubular
`structure,” as recited in claim 52 of the ʼ776 patent; and
`“the segment defining the side opening … is more rigid than the [a] distal end
`portion of the tubular structure,” as recited in claim 52 of the ʼ116 patent and
`claim 48 of the ʼ760 patent.
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`(1) “wherein a material forming the segment defining the side opening is more
`rigid than the tubular structure” means “wherein the matter forming the segment
`defining the side opening is more rigid than the tubular structure”;
`(2) “formed from a material more rigid than a material or material combination
`forming the tubular structure” means “formed from matter that is more rigid than
`the matter forming the tubular structure”; and
`(3) “formed from a material having a greater flexural modulus than a flexural
`modulus of the tubular structure” means “formed from matter having a greater
`flexural modulus than a flexural modulus of the tubular structure.”
`a.
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`The Boosting Catheter Meets the Requirement of Claim 25 of
`the ’760 Patent that “A Material Forming the Segment
`Defining the Side Opening Is More Rigid Than the Tubular
`Structure.”
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 18 of 40
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`1
`The claims quoted above from the ’760 and ’116 patents recite “a segment defining a side
`opening,” while the claims quoted above from the ’776 patent recite “a segment defining a
`partially cylindrical opening.” For the reasons set forth in this paragraph, I treat the two phrases
`as the same, and my analysis of the Boosting Catheter applies equally to both phrasings.
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 20 of 40
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`Exhibit B at 30-31.
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 21 of 40
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 22 of 40
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`b.
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`The Boosting Catheter Meets the Requirement of Claim 25 of
`the ’776 Patent that the “Segment Defining the Partially
`Cylindrical Opening [Is] Formed from a Material More Rigid
`than a Material or Material Combination Forming the
`Tubular Structure.”
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 23 of 40
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`c.
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`The Boosting Catheter Meets the Requirement of Claim 52 of
`the ’776 Patent that the “Segment Defining the Partially
`Cylindrical opening [Is] Formed from a Material Having a
`Greater Flexural Modulus than a Flexural Modulus of the
`Tubular Structure.”
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`d.
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`The Boosting Catheter Meets the Requirement of Claim 52 of
`the ’116 Patent and Claim 48 of the ’760 Patent that the
`“Segment Defining the Side Opening … Is More Rigid than the
`[a] Distal End Portion of the Tubular Structure.”
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 24 of 40
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`e.
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`Response to QXM’s Marker Band Argument
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 25 of 40
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`4.
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`“Inclined Region that Tapers into a Non-Inclined Region”
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 26 of 40
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`5.
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`“At Least Two Inclined Regions”
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`IV. CLAIM 53 OF THE ’116 PATENT IS NOT ANTICIPATED BY ADAMS
`A.
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`Background on Adams
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 29 of 40
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`B.
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`Adams Does Not Disclose “A Segment Defining A Side Opening.”
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 30 of 40
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`C.
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`Rigidity Comparisons
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`An end tip 255a is formed by wicking cyanoacrylate adhesive
`between the inner and outer layers 267 and 268 and coil spring 266
`to assure that the inner and outer layers 267 and 268 of the tip do
`not separate from the coil spring 266 as the extension 250 is
`advanced for use and treatment.
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`Id. at 14:48-52. The distal tube of Adams would be more rigid with that coil than without it. It
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`is unclear how much rigidity the flattened pushrod’s distal end would add to the funnel,
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`especially in comparison to the tube’s coil.
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 31 of 40
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`V.
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`INDEFINITENESS
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` be “proximal of [and] operably connected to … the flexible tip portion”;
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` be “more rigid along a longitudinal axis than the flexible tip portion “;
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` “defin[e] a rail structure without a lumen”; and
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` “hav[e] a maximal cross-sectional dimension at a proximal portion that is smaller
`than the cross-sectional outer diameter of the flexible tip portion.”
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 36 of 40
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`VI. RECAPTURE
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 37 of 40
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`a substantially rigid portion proximal of and operably connected to
`the flexible tip portion and defining a non-tubular structure having
`a maximal cross-sectional dimension at a proximal portion that is
`non-circular and smaller than the cross-sectional outer diameter of
`the flexible tip portion . . . .
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`Merrill Dec., Ex. 13, at 3. The examiner rejected the claims over the Solar and Niazi prior art
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`and on the grounds that the “non-tubular” and “non-circular” limitations lacked written
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`description support. Merrill Dec., Ex. 14, at 2-4. VSI then amended the claims to remove the
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`“non-tubular” and “non-circular” limitations and added the requirement that the substantially
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`rigid portion be “more rigid along a longitudinal axis than” the flexible tip portion:
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`a substantially rigid portion proximal of and operably connected to,
`and more rigid along a longitudinal axis than, the flexible tip
`portion and defining a non tubular structure having a maximal
`cross-sectional dimension at a proximal portion that is non circular
`and smaller than the cross-sectional outer diameter of the flexible
`tip portion . . . .
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`Merrill Dec., Ex. 15, at 3. Following an examiner’s amendment to add “rail structure without a
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`lumen,” the examiner withdrew the rejections and allowed the claims to issue. Merrill Dec., Ex.
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`16, Notice of Allowance at 2. The “substantially rigid portion” in the allowed claims reads, with
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`the language added by the Examiner underscored:
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`a substantially rigid portion proximal of and operably connected to,
`and more rigid along a longitudinal axis than, the flexible tip
`portion and defining a rail structure without a lumen and having a
`maximal cross-sectional dimension at a proximal portion that is
`smaller than the cross-sectional outer diameter of the flexible tip
`portion . . . .
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`CASE 0:17-cv-01969-PJS-TNL Document 137 Filed 04/30/19 Page 38 of 40
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`According to the invention, an enhanced balloon dilatation
`delivery system comprises an elongated advancement member
`which optionally terminates in a tubular tracking member, an
`inflatable dilatation balloon having proximal and distal ends and
`being in fluid communication with an inflation channel, and means
`for aligning the advancement member and the inflation channel.
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`Merrill Dec., Ex. 18, at ¶14. Figures 1 (annotated) and 12 below illustrate the invention of the
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`Solar Publication:
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