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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`
`
`Case IPR2020-01344
`U.S. Patent No. RE 46,116
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`PATENT OWNER RESPONSE
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`TABLE OF CONTENTS
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`Page
`
`INTRODUCTION ........................................................................................... 1
`I.
`BACKGROUND ............................................................................................ 2
`II.
`III. THE ‘116 PATENT ......................................................................................... 3
`IV. THE PERSON OF ORDINARY SKILL IN THE ART ................................. 7
`PETITIONER HAS NOT SHOWN THAT THE CHALLENGED CLAIMS
`V.
`OF THE ‘116 PATENT ARE INVALID ........................................................ 7
`A. GROUND II: Petitioner Fails to Show That Kontos In View of
`Ressemann, Takahashi and/or the Knowledge of a POSITA Renders
`Independent Claim 25 Obvious ............................................................. 7
`Petitioner’s prior art references ................................................... 8
`1.
`Kontos (Ex-1409) ............................................................ 8
`i.
`ii.
`Ressemann (Ex-1408) .................................................... 10
`iii. Takahashi (Ex-1410) ..................................................... 12
`Petitioner has not shown that it would have been obvious to
`modify Kontos to create a “side opening” ............................... 12
`Removing Kontos’ Funnel Would Have Been Expected
`i.
`to Create Problems, Not Solve Them ............................. 13
`Petitioner’s Alleged Motivations Are Based on Hindsight
`and/or Unsupported by the Evidence ............................. 18
`Petitioner has not shown that it would have been obvious to
`modify Kontos to meet the “not more than one French smaller”
`limitiation .................................................................................. 25
`B. GROUND II: Additional Reasons Why Petitioner’s Obviousness
`Arguments Fail as to Certain Dependent Claims ................................ 30
`Petitioner has not shown that the proposed modifications would
`1.
`meet the limitations of dependent claim 32 .............................. 30
`Petitioner has not shown that it would have been obvious to
`advance a delivery system including a stent through Kontos’
`support catheter as recited in claim 37 ...................................... 31
`
`2.
`
`i
`
`2.
`
`3.
`
`ii.
`
`

`

`3.
`
`ii.
`
`Petitioner has not shown it would have been obvious to modify
`Kontos’ device to create a “side opening structure having at
`least two inclined slopes” as recited in claim 45 ...................... 32
`Ressemann Undisputedly Does Not Disclose a Device
`i.
`with a Side Opening that Includes At Least Two Inclined
`Slopes .............................................................................. 33
`The So-Called “Incline #1” at the Tip of Ressemann’s
`Collar Tab Portion Serves No Purpose in Ressemann ... 37
`iii. Even Assuming a POSITA Was Motivated to Combine
`Kontos and Ressemann, Petitioner Has Not Shown that
`the Resulting Combination Would Satisfy the Claim
`Language or Would Be Reasonably Expected to Work . 38
`C. GROUND I: Petitioner Fails to Show That Kontos In View of
`Ressemann Renders Claims 52 and 53 Obvious ................................. 44
`D. GROUND III: Petitioner’s Four-Reference Challenge (Kontos,
`Ressemann, Takahashi and Kataishi) Fails to Show that Claim 45
`Would Have Been Obvious ................................................................. 44
`Kataishi (Ex-1425) ................................................................... 44
`1.
`2.
`Petitioner’s Obviousness Arguments Based on Kataishi Are
`Without Merit ............................................................................ 46
`E. GROUNDS IV and V Should Be Rejected Because the Root
`Publication Is Not Prior Art (All Challenged Claims) ....................... 50
`The Root-based Grounds are an impermissible back door
`1.
`attempt to challenge written description ................................... 51
`The Root reference is not prior art because the challenge claims
`are supported by the written description ................................... 52
`The ‘629 Application Discloses a Device Having Both a
`i.
`“Segment Defining a Side Opening” and a “Substantially
`Rigid Segment” as Claimed ............................................ 52
`The ‘629 Application Discloses a Side Opening Having
`“At Least Two Inclined Slopes” as Recited in Claim 45
` ........................................................................................ 59
`
`2.
`
`ii.
`
`ii
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`

`

`F.
`
`The Objective, Real-World Evidence Shows That the Invention
`Recited in Claim 25 Was Not Obvious ............................................... 61
`Long-Felt Need ......................................................................... 62
`1.
`2.
`Commercial Success ................................................................. 65
`3.
`Industry Praise ........................................................................... 68
`4.
`Licensing ................................................................................... 69
`5.
`Copying ..................................................................................... 70
`Boston Scientific’s Guidezilla ........................................ 70
`i.
`ii.
`QXM’s Boosting Catheter .............................................. 72
`iii.
`Petitioner’s Telescope ..................................................... 72
`iv.
`There Is Nexus Between the Invention of Claim 25 and
`the Objective Evidence of Non-obviousness .................. 77
`The Petition Should Be Denied Because Inter Partes Review Is
`Unconstitutional .................................................................................. 82
`VI. CONCLUSION ........................................................................................ 83
`
`G.
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`iii
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`

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`TABLE OF AUTHORITIES
`
`
`Cases
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034, 1054 (Fed. Cir. 2016) ..................................................................... 76
`Arctic Cat Inc. v. Bombardier Rec. Prods.,
`876 F.3d 1350, 1363 (Fed. Cir. 2017) ..................................................................... 17
`Arthrex, Inc. v. Smith & Nephew, Inc.,
`941 F.3d 1320, 1325 (Fed. Cir. 2019) ..................................................................... 82
`Bilstad v. Wakalopulos,
`386 F.3d 1116, 1125 (Fed. Cir. 2004) .............................................................. 55, 59
`Ethicon Endo-Surgery, Inc. v. United States Surgical Corp.,
`93 F.3d 1572, 1582 n.7 (Fed. Cir. 1996) .......................................................... 55, 60
`Fox Factory, Inc. v. SRAM, LLC,
`944 F.3d 1366, 1373-74 (Fed. Cir. 2019) ......................................................... 77, 82
`Gambro Lundia AB v. Baxter Healthcare Corp.,
`110 F.3d 1573, 1579 (Fed. Cir. 1997) ..................................................................... 79
`In re Global IP Holding LLC,
`927 F.3d 1373, 1377 (Fed. Cir. 2019) ..................................................................... 55
`Institut Pasteur & Universite Pierre Et Marie Curie v. Focarino,
`738 F.3d 1337, 1344 (Fed. Cir. 2013) ........................................................ 17, 68, 69
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359, 1367-68 (Fed. Cir. 2016) ................................................................ 25
`Intendis GmbH v. Glenmark Pharm., Inc.,
`822 F.3d 1355, 1362 (Fed. Cir. 2016) ..................................................................... 76
`Intri-Plex Techs. Inc. v. Saint-Gobain Performance Plastics Rencol Ltd.,
`IPR2014-00309, Paper 83 at 41 (PTAB Mar. 23, 2015) ......................................... 70
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317, 1325 (Fed. Cir. 2004) ..................................................................... 76
`Kvaerner Oilfield Prods.,
`291 F.3d 1317, 1322-23 (Fed. Cir. 2002) ................................................................ 52
`Lampi Corp. v. Am. Power Prods., Inc.,
`228 F.3d 1365, 1377-78 (Fed. Cir. 2000) ................................................................ 57
`
`iv
`
`

`

`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 33 at 33 (PTAB Jan. 24, 2020) ........................................... 77
`Lucia v. SEC,
`138 S. Ct. 2044, 2055 (2018) ................................................................................... 83
`Rexnord Corp. v. Laitram Corp.,
`274 F.3d 1336, 1344 (Fed. Cir. 2001) ..................................................................... 54
`Securus Techs., Inc. v. Glob. Tel*Link Corp.,
`701 F. App’x 971, 976-77 (Fed. Cir. 2017) ............................................................. 48
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340, 1349 (Fed. Cir. 2012) ..................................................................... 61
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317, 1330-31 (Fed. Cir. 2016) ......................................................... 63, 77
`Wyers v. Master Lock Co.,
`616 F.3d 1231, 1246 (Fed. Cir. 2010) ..................................................................... 70
`Other Authorities
`35 U.S.C. §112 ......................................................................................................... 51
`35 U.S.C. §311(b) .................................................................................................... 51
`
`v
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`

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`I.
`
`INTRODUCTION
`The ’116 patent is one of the family of patents covering an industry-
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`changing product called GuideLiner. When Patent Owner’s predecessor, Vascular
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`Solutions, Inc. (“VSI”), introduced GuideLiner in 2009, it created a new product
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`category called “guide extension catheters.” GuideLiner was the first product that
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`solved the long-felt need for better backup support during the catheter-based
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`treatment of diseased coronary arteries.
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`The method that GuideLiner made possible is recited in the claims of the
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`’116 patent and distinguishes the claims over the art relied on in Grounds 1-3. The
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`claims are directed to advancing a balloon catheter or stent through a guide
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`extension catheter having, inter alia, “a segment defining a side opening” and a
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`tubular structure having an inner diameter “not more than one French size smaller”
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`than the diameter of the guide catheter. Kontos, the primary reference relied on for
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`Grounds 1-3, undisputedly does not disclose either claim limitation, and
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`Petitioner’s picking and choosing of features from multiple secondary references is
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`both hindsight-based and contrary to the purpose and teachings of Kontos.
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`There is also remarkably strong objective evidence of nonobviousness for
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`challenged independent claim 25.
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`Finally, Grounds 4 and 5 of the Petition should be rejected for the simple
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`reason that the Root Publication underlying those grounds does not qualify as prior
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`1
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`

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`art. The Root Publication is not merely similar to the ʼ116 patent; with the
`
`exception of the claims, the disclosure is identical to that of the ʼ116 patent.
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`Indeed, the ʼ116 patent is a broadening continuation reissue patent that claims
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`priority to the Root Publication and was filed specifically because the patentee had
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`claimed “less than they were entitled to claim” in the patent that issued from the
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`Root Publication and two subsequent divisional patents. As explained below,
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`Petitioner’s back-door written description challenge should be rejected because the
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`claims of the ʼ116 patent are well-supported by the very same priority application
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`that published as the Root Application.
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`II. BACKGROUND
`Since at least the late 1980s, physicians have been treating diseased coronary
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`arteries using catheter-based minimally invasive techniques. Ex-1401, 1:59-2:3;
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`Ex-2145, ¶¶41-75; Ex-2138, ¶¶51-53. However, when interventional cardiology
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`devices encountered a complex lesion or a tortuous anatomy, it generated a back-
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`force that caused the guide catheter to “pop out” of the coronary artery ostium. Ex-
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`1401, 1:66-2:3; Ex-2145, ¶49; Ex-2138, ¶¶51-53.
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`It was not until 2004 when VSI invented GuideLiner that someone came up
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`with a solution that, for the first time, solved the backup support issue. Ex-2145,
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`¶¶76-80, 85-91; Ex-2138, ¶¶312, 314, 320; Ex-2151, ¶9. In GuideLiner, VSI
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`invented a method of improving backup support by using a device with “rapid
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`2
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`

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`exchange” functionality that could still deliver the full array of interventional
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`cardiology devices (including stents). Ex-2145, ¶¶85-91; Ex-2138, ¶¶63-69, 312,
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`362.
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`GuideLiner succeeded beyond the inventors’ wildest expectations. It
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`quickly became VSI’s flagship product and created a new product category called
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`“guide extension catheters.” Ex-2138, ¶319; Ex-2118, ¶4; see also Ex-2145, ¶¶76-
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`80; Ex-2151 ¶¶9-16; Ex-2215, ¶¶2, 7-9, 20-29.
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`III. THE ʼ116 PATENT
`The ’116 patent is directed to a method of using a guide extension catheter
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`that is passed through the lumen of a guide catheter, advanced beyond the distal
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`end of the guide catheter, and inserted into a branch artery of the aorta to facilitate
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`delivery of stents or balloon catheters. Ex-1401, Abstract, cl. 25.
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`The guide extension catheter generally includes, from distal to proximal
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`direction, a soft tip portion, a tubular portion, and a substantially rigid portion that
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`has a rail segment to permit delivery without blocking use of the guide catheter.
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`E.g., id., 6:45-46, Figs. 1, 4, 20-22; Ex-2138, ¶86. Figures 1 and 9 (color added)
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`show an embodiment of the invention:
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`3
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`

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`
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`An important advantage of the design is it only slightly reduces available space to
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`deliver interventional cardiology devices—by no more than one French size
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`relative to the lumen of the guide catheter in the preferred embodiment. Ex-1401,
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`3:39-55; Ex-2138, ¶86.
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`The guide extension catheter preferably includes a side or angled opening as
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`shown below in Figures 4 and 12-13:
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`4
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`

`

`
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`Ex-1401; see also id., 7:7-10 (red arrows added to indicate direction of
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`
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`interventional device); Ex-2138, ¶87.
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`An exemplary claim—is provided below:
`
`25. A method comprising:
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`advancing a distal end of a guide catheter having a lumen
`through a main blood vessel to an ostium of a coronary artery;
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`advancing a distal end of a guide extension catheter through,
`and beyond the distal end of, the guide catheter, including
`advancing a distal end portion of a tubular structure of the guide
`extension catheter beyond the distal end of the guide catheter
`while a segment defining a side opening of the guide extension
`
`5
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`

`

`catheter remains within the guide catheter, the side opening
`extending for a distance along a longitudinal axis of the guide
`extension catheter and accessible from a longitudinal side
`defined transverse to the longitudinal axis, 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;
`
`maintaining the distal end portion of the tubular structure of the
`guide extension catheter in position beyond the distal end of the
`guide catheter; and
`
`while maintaining the distal end of the guide extension catheter
`positioned beyond the distal end of the guide catheter,
`advancing a balloon catheter or stent at least partially through
`the guide catheter and the guide extension catheter and into the
`coronary artery, including advancing the balloon catheter or
`stent through a hemostatic valve associated with a proximal end
`of the guide catheter, along a substantially rigid segment of the
`guide extension catheter, through the side opening, and through
`the tubular structure.
`
`Ex-1401, 13:62-14:25.
`
`6
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`

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`IV. THE PERSON OF ORDINARY SKILL IN THE ART
`For the purposes of this Response only, Patent Owner applies Petitioner’s
`
`proposed definition of a POSITA.1 Petition, 11-12.
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`V.
`
`PETITIONER HAS NOT SHOWN THAT THE CHALLENGED
`CLAIMS OF THE ’116 PATENT ARE INVALID
`A. GROUND II: Petitioner Fails to Show That Kontos In View of
`Ressemann, Takahashi, and/or the Knowledge of a POSITA
`Renders Independent Claim 25 Obvious
`Independent claim 25 recites a method of using a device that differs
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`substantially from that of Kontos, the primary reference relied on in Ground 2.
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`This is reflected by the fact that Petitioner needs to use elements from two very
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`different secondary references (Ressemann and Takahashi) and makes multiple
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`distinct modifications to the Kontos device to recreate the claimed invention. Not
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`only are the modifications proposed by Petitioner based on hindsight, but
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`1 The Petitioner’s engineering expert, Richard Hillstead, does not appear to meet
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`the Petitioner’s definition of a POSITA. Ex-2137, 462:8-13; Ex-1443, 2.
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`Petitioner’s physician expert, Dr. Brecker, has conceded that he does not “have
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`huge experience of using the commercially available guide extensions” and that his
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`practice has been more focused in the structural heart space than complex PCI.
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`Ex-2245, 39:5-7; see also id., 43:6-13, 36:19-21, 27:4-8, 44:17-23, 46:15-20,
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`67:15-68:13, 69:19-70:8.
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`7
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`

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`Petitioner fails to explain how the resulting device would actually meet the
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`limitations of claim 25 as a whole.
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`1.
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`Petitioner’s prior art references
`Kontos (Ex-1409)
`i.
`Kontos teaches a “support catheter” that has very different purposes, and
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`uses a different structure, than the invention of the ’116 patent. See Ex-2138,
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`¶¶108-28; Ex-2145, ¶¶146-47. Kontos is specifically designed to “protect[] the
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`fragile balloon” of a PTCA balloon catheter2 during delivery and/or exchanges.
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`E.g. Ex-1409, 5:52-56; Ex-2244, 103:12-15; Ex-2245, 129:7-11; Ex-2138, ¶¶109-
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`11; Ex-2145, ¶147. Kontos discloses a second purpose where the support catheter
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`itself serves as a temporary stent. Ex-1409, 6:59-7:5; Ex-2138, ¶112; Ex-2145,
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`¶147. The third disclosed purpose is to facilitate the exchange of fixed wire
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`balloon catheters. Ex-1409, 7:6-22; Ex-2138, ¶¶113-15, 247.
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`To achieve its purposes, Kontos discloses structure consisting of an
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`insertion/manipulation wire 14 embedded in a body 12:
`
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`2 A POSITA would have understood Kontos’ references to “PTCA catheter” to
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`mean a fixed wire balloon catheter. Ex-2138, ¶¶114-15; Ex-2145, ¶146; Ex-2137,
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`287:6-8.
`
`8
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`

`

`Ex-1409, Fig. 1. At the proximal end of the body, a base portion 18 bulges
`
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`downward to facilitate insertion and attachment of wire 14, while a funnel portion
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`26 flares upward to facilitate entry of a PTCA balloon catheter. At the distal end,
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`the body is surrounded by another raised profile section consisting of marker band
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`
`
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`30 and a soft tip 28:
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`
`
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`Id., Fig. 1 (annotated), 3:45-4:24; Ex-2138, ¶121; Ex-2145, ¶148. The central tube
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`16 of the body is relatively narrow, with an outer diameter of 0.055 inches and an
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`inner diameter of 0.045 inches. Ex-1409, 4:48-50. The narrow tube is important
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`9
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`

`

`to Kontos’ disclosed functions: it allows a close fit around a received small-
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`diameter PTCA catheter to effectively support it and prevent buckling, and it
`
`maintains a small diameter exterior profile to allow the support catheter itself to
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`function as a temporary stent. Ex-1409, 4:61-62, 5:18-24, Fig. 5; Ex-2138, ¶117;
`
`Ex-2244, 104:6-15.
`
`Kontos’ deliberately asymmetric structure results in a significant gap
`
`between the exterior wall of the long central portion of tube 16 and the interior
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`wall of the guide catheter:
`
`Gap
`
`
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`Ex-2138, ¶123; Ex-2145, ¶¶144-49; see also Ex-2245, 133:14-22, 124:3-11. This
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`gap exists regardless of what sized guide catheter the device is used with. Ex-
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`2138, ¶123; Ex-2145, ¶148.
`
`Ressemann (Ex-1408)
`ii.
`Ressemann discloses embolic protection devices that use inflatable balloons
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`to temporarily occlude blood flow to enable the capture/removal of bits of debris
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`dislodged during treatment. Ex-1408, 2:56-61, 5:65-67, 8:5-28, 33:4-6, 33:25-28;
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`Ex-2138, ¶101, 157-58; Ex-2145, ¶¶135-37; Ex-2244, 99:15-23; Ex-2245, 62:1-11,
`
`10
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`

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`121:16-122:13. Ressemann positions the balloons on an evacuation sheath with a
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`“multi-lumen tube” consisting of multiple offset lumens, including a larger
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`evacuation lumen 140 for capturing emboli and passing interventional devices and
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`a smaller inflation lumen 142 connected to proximal and distal balloons that are
`
`inflated to block blood flow. E.g., Ex-1408, 6:35-65, Figs. 1A, 1B, 16D, 16E; Ex-
`
`2138, ¶101. Figures 1A and 1B show an embodiment of Ressemann’s evacuation
`
`sheath assembly:
`
`
`
`Ex-1408, Figs. 1A, 1B. The sheath’s proximal end 140a has a single-angle
`
`opening. Id., 6:35-65; Ex-2138, ¶101.
`
`Figures 16A-16J show another embolic protection embodiment that also has
`
`a single-angle proximal opening:
`
`11
`
`

`

`Angled Opening
`
`
`
`
`
`Ex-1408, Fig. 16A (annotated), 24:33-35; Ex-2138, ¶102.
`
`iii.
`
`Takahashi (Ex-1410)
`
`
`
`2.
`
`Petitioner has not shown that it would have been obvious to
`modify Kontos to create a “side opening”
`The Petition concedes that Kontos does not teach the claimed “segment
`
`defining a side opening.” Petition, 18. Instead, Petitioner argues that “[a] POSITA
`
`would have been motivated…to add Ressemann’s side opening to Kontos.” Id.,
`
`20. But this proposed modification would actually create problems that are
`
`inconsistent with the stated purpose of the Kontos device, demonstrating non-
`
`obviousness. Ex-2138, ¶¶205-18; Ex-2145, ¶¶201-03. In addition, the Petition’s
`
`12
`
`

`

`proffered motivations evidence clear hindsight and are not supported by the
`
`evidence.
`
`i.
`
`Removing Kontos’ Funnel Would Have Been
`Expected to Create Problems, Not Solve Them
`The primary purpose of Kontos’ support catheter is to facilitate the delivery
`
`of “extremely soft and flexible” PTCA balloon catheters that are “readily
`
`susceptible to kinking and bending.” E.g., Ex-1409, 1:9-16, 1:30-37; Ex-2138,
`
`¶205; Ex-2145, ¶¶146-47. Kontos achieves this by providing a narrow tube 16 to
`
`fit closely around the “fragile” PTCA catheter. Ex-1409, 4:48-50, 4:25-30, 5:18-
`
`24, 5:49-56; Ex-2138, ¶205.
`
`However, the narrow dimension of tube 16 and the larger-diameter,
`
`protruding base portion 18 (as well as the larger diameter tip portion 28) creates a
`
`substantial gap with the inner wall of the guide catheter 38:
`
`
`
`Gaps between walls
`
`
`
`
`
`
`
`13
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`

`

`Ex-1409, Fig. 6A (annotated); Ex-2138, ¶209; Ex-2145, ¶¶148-49. To address this
`
`gap, Kontos teaches a “funnel portion 26 [to] facilitate[] passage of the PTCA
`
`catheter 40 from the guide catheter 38 into lumen 22 of body 12.” Ex-1409, 7:49-
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`52; see also id., 5:37-39, 7:20-22, 8:51-54, 9:13-15; Ex-2244, 105:1-8. Indeed,
`
`Kontos explains (and a POSITA would understand) that the funnel portion is
`
`important to the device’s ability to receive and facilitate exchange of balloon
`
`catheters. Ex-1409, 3:66-68; see also id. 7:20-22, 7:49-52; Ex-2244, 105:9-18; Ex-
`
`2138, ¶210; Ex-2145, ¶149.
`
`While Petitioner characterizes its proposed modification as simply “add[ing]
`
`Ressemann’s side opening to Kontos,” (Petition, 20), in reality it would first
`
`require a POSITA to completely remove Kontos’ funnel and then replace it with
`
`Ressemann’s angled opening, as shown below:
`
`Id. But a POSITA would have expected removing Kontos’ funnel portion to make
`
`the device less effective, because it would expose the gap that the funnel was
`
`intended to bridge, and greatly increase the likelihood of an inserted device
`
`catching or hanging-up. Ex-2138, ¶211-15; Ex-2145, ¶¶201-03; Ex-2244, 105:1-5;
`
`
`
`14
`
`

`

`Ex-2137, 452:7-17, 357:13-23, 362:3-10 (agreeing that Ressemann discloses a
`
`“hang-up” problem with its angled proximal opening that is not present in the
`
`funnel embodiment). Kontos as modified by the Petition (at 20) is shown below
`
`inside the guide catheter, with the coil tip of an advancing balloon catheter
`
`catching in the gap:
`
`
`
`Ex-2138, ¶212; Ex-2145, ¶201; Ex-2245, 179:22-180:4, 178:9-17. Petitioner’s
`
`expert asserts that hang-up or catching of interventional cardiology devices was a
`
`“known” problem at the time of the invention (Ex-1442, ¶137), yet Petitioner
`
`entirely ignores the problem this modification would create. Ex-2138, ¶¶214-15.
`
`Petitioner’s expert cites Ressemann for the proposition that an angled
`
`opening would somehow “reduce” hang-up issues (Ex-1442, ¶137), but this is not
`
`credible. Ressemann teaches the opposite. Ex-2138, ¶214. Ressemann states that
`
`“[s]tent delivery catheters, for example, are particularly subject to hanging-up” on
`
`the angled proximal opening of the evacuation head, and proposes using a different
`
`15
`
`

`

`structure (“reverse bevel 2125”) to try to mitigate this. Ex-1408, 25:17-29
`
`(emphasis added); Ex-2138, ¶214. In contrast, Ressemann’s Figure 11
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`embodiment uses a “flare 131” similar to Kontos’ funnel, and Ressemann does not
`
`identify any catching or hang-up issues created by such flare. Ex-1408, 7:40-47,
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`Fig. 11A; Ex-2244, 150:14-151:1; Ex-2138, ¶214; Ex-2145, ¶202. Notably,
`
`Petitioner’s expert was unable to identify any prior art (besides Ressemann) that
`
`discloses advancing a balloon or stent through an angled proximal opening, (Ex-
`
`2240, 21:22-22:3; Ex-1900, ¶171), or through a proximal opening with a gap
`
`between an inner tubular device and the inner wall of a surrounding guide catheter
`
`(Ex-2245, 184:2-12). In view of these teachings, a POSITA would not have been
`
`motivated to slice off the funnel of Kontos as the Petitioner advocates, in view of
`
`the significant catching/hang-up problems it would create. Ex-2138, ¶¶214-15;
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`Ex-2145, ¶203.
`
`
`
`Removing Kontos’ funnel would also be counterproductive for the purpose
`
`of that device because it would reduce the target area for receiving fixed-wire
`
`balloons through the proximal opening in an axial direction. Ex-2138, ¶¶216-17.
`
`This is illustrated by the diagrams below:
`
`16
`
`

`

`Axis of Kontos’
`lumen
`
`Target area in
`Kontos as disclosed
`
`Reduced target area,
`following Petitioner’s
`proposed modification
`
`
`
`
`Id., ¶216. A balloon catheter advancing in an axial direction does not change its
`
`angle of entry into the Kontos tube portion when the angle of the plane of the
`
`opening changes. Id., ¶217. Thus, even if the funnel of Kontos were replaced with
`
`an angled opening like that found in Ressemann, the target area would be
`
`significantly reduced, corresponding to the size of the Kontos tube portion. Id.
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`Evidence allegedly suggesting reasons to combine references “cannot be
`
`viewed in a vacuum apart from evidence suggesting reasons not to combine.”
`
`Arctic Cat Inc. v. Bombardier Rec. Prods., 876 F.3d 1350, 1363 (Fed. Cir. 2017).
`
`Moreover, in failing to address the acute problems with device catching/hang-up
`
`that the proposed modification would create, Petitioner has failed to show that a
`
`POSITA would reasonably expect the modification to be successful. E.g. Institut
`
`Pasteur & Universite Pierre Et Marie Curie v. Focarino, 738 F.3d 1337, 1344
`
`17
`
`

`

`(Fed. Cir. 2013). For this reason alone, the Petition fails to show that the
`
`challenged claims would have been obvious.
`
`ii.
`
`Petitioner’s Alleged Motivations Are Based on
`Hindsight and/or Unsupported by the Evidence
`Petitioner asserts that “[t]he use of side openings . . . were well-known.”
`
`Petition, 18. This is simply not true. The claims of the ʼ116 patent require
`
`“advancing a balloon catheter or stent . . . . through the side opening.” E.g., Ex-
`
`1401, 14:16-25. Of the long list of references cited on page 18 of the Petition, the
`
`only one disclosing a device with a partially cylindrical opening used to receive
`
`interventional cardiology devices when positioned within a guide catheter is
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`Ressemann. Ex-2138, ¶¶220-27; Ex-2145, ¶¶112-14. This shows that, far from
`
`being “well-known,” partially cylindrical openings as claimed were actually very
`
`rare.3
`
`Petitioner provides four purported “motivations” for why a POSITA would
`
`focus on Ressemann’s angled opening and incorporate it into Kontos’ support
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`catheter. Petition, 20-24. Each is unsupported by the evidence and/or based on
`
`hindsight.
`
`
`3 Further confirming this rarity: the commercialized version of Ressemann
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`employed a full-length evacuation lumen. Ex-2138, ¶¶ 69, 227; Ex-2213, 10.
`
`18
`
`

`

`Petitioner first argues that a POSITA would have been motivated to remove
`
`Kontos’ funnel and add Ressemann’s support collar to “permit a reduction of the
`
`outer diameter of the catheter assembly without resulting in a commensurate
`
`reduction in the area of the point of entry of the extension catheter.” Petition, 20-
`
`21 (citing Ex-1405, ¶¶162-164; Ex-1442, ¶¶134-135). This argument is hindsight
`
`untethered from the actual teaching of the references. The Kontos device is not
`
`premised on employing the smallest guide catheter possible, but rather on creating
`
`a device that (1) can closely fit about existing balloon catheters, and (2) has
`
`outward protrusions at the proximal and distal ends of the device that create limited
`
`points of contact with the guide catheter. Ex-2138, ¶229; Ex-2145, ¶¶204, 193.
`
`This can be seen from the fact that even in the embodiment of Figures 10-13 (a
`
`full-length device that has no funnel), Kontos employs structures at each end of the
`
`body 112 that protrude outwardly from the central tube 116. Ex-2138, ¶229; Ex-
`
`1409, 8:25-30, 8:55-59, Figs. 10-13.
`
`In this regard, the funnel portion of Kontos is not what primarily drives the
`
`outer diameter. Ex-2138, ¶230. Rather, it is the proximal protrusion of base
`
`portion 18, which provides the pushwire attachment point, as well as the distal
`
`marker band:
`
`19
`
`

`

`Tip/marker band structure
`
`Base portion 18 for
`pushrod (wire 14)
`attachment
`
`
`
`Ex-1409, Fig. 1 (annotated); Ex-2138, ¶230; Ex-2145, ¶¶204, 193. Base portion
`
`18 is necessary to Kontos’ function. The funnel also is needed to at least partially
`
`bridge the gap between the interior wall of the guide catheter and the smaller
`
`central portion of Kontos’ tube 16. Ex-2138, ¶231; Ex-2145, ¶197. A POSITA
`
`would not expect removing the funnel to allow any meaningful reduction in the
`
`overall diameter the catheter assembly, as the outer diameter would still be at least
`
`0.065 inches, far too large to fit inside a 5 French guide catheter. Ex-2138, ¶231;
`
`Ex-2145, ¶196.
`
`Kontos and other contemporaneous art taught the use of a funnel for a device
`
`with a lumen that is significantly smaller in diameter than the inner diameter of the
`
`guide catheter. Ex-2138, ¶235 (citing Ex-1409, 3:66-68, 7:20-22, 7:49-52; Ex-
`
`1434 (Adams ’292), 16:1-15). The Petition’s focus on removing the funnel portion
`
`20
`
`

`

`of Kontos, while ignoring the rest of Kontos’ teaching, shows that the analysis is
`
`improperly hindsight-driven.
`
`Petitioner’s purported motivation is also based on the unsupported premise
`
`that a POSITA would want to reduce the outer diameter surrounding the guide
`
`catheter in the first place. Petitioner’s experts cite a textbook published in 2000
`
`stating that there was an industry transition from 7 and 8 French catheters towards
`
`smaller 6 French catheters. Ex-1415, 548-49 (cited in Ex-1405, ¶46 and Ex-1442
`
`at ¶87). But the device described in Kontos is already sized consistent with usage
`
`of a 6 French guide catheter. Ex-2138, ¶¶232-33; Ex-2145, ¶195. Petitioner’s
`
`expert agrees. Ex-2137, 319:3-6 (“Yeah, I think it would [fit inside a 6 French
`
`guiding catheter]”). Moreover, a later edition of the very same textbook makes
`
`clear that even as late as 2013 (many years after the priority date of the ’116
`
`patent), there was no desire or need to use guide catheters smaller than 6 French.
`
`Ex-2167, 33 (“[M]ost procedures in current practice can be completed through 6F
`
`guiding catheters. Also available are 5F guiding catheters, but they offer no major
`
`advantage and are not routinely used.”); Ex-2145, ¶194; see also Ex-2137, 53:15-
`
`19 (“[I]n that [time]frame, I don’t think anybody had a five French”); Ex-2116,
`
`288:6-7 (“So early 2000s, I think would still have been 6, 7s, maybe s