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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 IPR2020-00128
`Case IPR2020-00129
`Case IPR2020-00130
`Patent RE 45,380
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`PATENT OWNER’S REPLY IN SUPPORT OF CONTINGENT MOTION
`TO AMEND U.S. PATENT RE 45,380 UNDER 37 C.F.R. § 42.121
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`TABLE OF CONTENTS
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`PAGE
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`I.
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`II.
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`III. PETITIONER’S ARGUMENTS OF UNPATENTABILITY ARE NOT
`PERSUASIVE ............................................................................................. 2
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`INTRODUCTION ....................................................................................... 1
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`SUBSTITUTE CLAIM 44 IS NOT INDEFINITE ..................................... 1
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`A. Claims 43 and 44 Are Patentable Over Itou in View of Either
`Ressemann or Kataishi ...................................................................... 2
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`1.
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`2.
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`Substitute Claim 43 ...................................................... 2
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`“Stent Catheters … Are Insertable” ................... 2
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`a.
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`b.
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`Substitute Claim 44 ...................................................... 4
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`Size and “Coaxial” Limitations .......................... 4
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`a.
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`b.
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`c.
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`Size and “Coaxial” Limitations .......................... 4
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`“Interventional Cardiology Devices Are
`Insertable” .......................................................... 5
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`Complex Side Opening ...................................... 5
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`Itou Plus Ressemann’s Collar .................. 6
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`Itou Plus Kataishi’s Distal Tip ................. 9
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`i.
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`ii.
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`B. Substitute Claims 43 and 44 Are Patentable Over Kontos in
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`View of Ressemann and Takahashi ................................................ 12
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`1.
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`Substitute Claim 43 .................................................... 12
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`“Stent Catheters … Are Insertable” ................. 12
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`a.
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`i
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`b.
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`c.
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`0.056 Inch Inner Diameter Tube in a 6 French
`Guide Catheter .................................................. 12
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`“Coaxial Lumen,” “Uniform, Fixed” Outer
`Tube Diameter, and "Flexible Cylindrical
`Reinforced Portion” .......................................... 16
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`2. Substitute Claim 44 .................................................... 16
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`“Coaxial” Lumen Through Which
`“Interventional Cardiology Devices Are
`Insertable” ........................................................ 16
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`0.056 Inner Diameter Tube in a 6 French
`Guide Catheter .................................................. 17
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`a.
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`b.
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`c. Complex Side Opening .................................... 17
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`Substitute Claim 44 Is Patentable Over Kontos and Kataishi ......... 19
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`C.
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`IV. CONCLUSION .......................................................................................... 19
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`CERTIFICATION OF SERVICE........................................................................ 21
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`CERTIFICATE OF WORD COUNT COMPLIANCE ....................................... 22
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`ii
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`TABLE OF AUTHORITIES
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`
`CASES
`Ashley Furniture Indus. v. Lifestyle Enter.
`574 F. Supp. 2d 920 (W.D. Wis. 2008) ................................................................. 13
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` PAGE
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`Campbell Soup Co. v. Gamon Plus, Inc.
`939 F.3d 1335 (Fed. Cir. 2019) ............................................................................ 13
`
`Datascope Corp. v. Kontron, Inc.
`611 F. Supp. 889 (D. Mass. 1985) ........................................................................ 13
`
`Douglas Dynamics, LLC v. Buyers Prods. Co.
`717 F.3d 1336 (Fed. Cir. 2013) .............................................................................. 1
`
`In re Schweickert
`676 F. App’x 988 (Fed. Cir. 2017) ....................................................................... 18
`STATUTES
`35 U.S.C. § 112 .......................................................................................................... 1
`OTHER AUTHORITIES
`37 C.F.R. § 42.121 ..................................................................................................... 1
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`
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`iii
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`I.
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`INTRODUCTION
`Patent Owner Teleflex submits this Reply in Support of Contingent Motion
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`to Amend U.S. Patent RE 45,380, with the Second Declaration of Peter T. Keith in
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`Support of Motions to Amend (“Ex-2243”), under 37 C.F.R. § 42.121. Teleflex
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`submits that Petitioner has failed to show that any of the substitute claims
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`presented in this motion is unpatentable.
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`II.
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`SUBSTITUTE CLAIM 44 IS NOT INDEFINITE
`Petitioner’s only § 112 challenge to the ’380 patent’s claims is that claim 44
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`is indefinite because it recites that the substantially rigid portion is “connected to”
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`the flexible tip portion. Opp., 1. “[A] claim … is unpatentable for indefiniteness if
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`the claim, read in light of the specification delineating the patent, and the
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`prosecution history, fails to inform, with reasonable certainty, those skilled in the
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`art about the scope of the invention.” Memorandum re: Approach to Indefiniteness
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`Under 35 U.S.C. § 112 in AIA Post-Grant Proceedings (January 6, 2021), 3.
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`Petitioner’s argument incorrectly assumes that “connected to” requires a direct
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`connection. Ex-2243, ¶46. “Connected to” includes direct and indirect
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`connections. E.g., Douglas Dynamics, LLC v. Buyers Prods. Co., 717 F.3d 1336,
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`1342 (Fed. Cir. 2013). Its expert confirms “the specification teaches an indirect
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`connection, such that the flexible tip portion is connected to the reinforced portion,
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`which is connected to the substantially rigid portion.” Ex-1902, 36 n.5, 93 n.10. It
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`1
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`argument also ignores that claim 44 specifically recites that the flexible tip extends
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`out the guide catheter while a portion of the reinforced portion extends within the
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`guide catheter and a proximal portion of the substantially rigid portion extends
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`through the hemostatic valve. This necessarily means that the flexible tip portion
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`is distal of the reinforced portion, which is distal of the substantially rigid portion,
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`as disclosed in the application. Ex-1003, 14:7-9, 16:12-19; Ex-2243, ¶46.
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`III. PETITIONER’S ARGUMENTS OF UNPATENTABILITY ARE NOT
`PERSUASIVE
`A. Claims 43 and 44 Are Patentable Over Itou1 in View of Either
`Ressemann or Kataishi
`1.
`Substitute Claim 43
`a.
`“Stent Catheters … Are Insertable”
`Claim 43 recites a “tubular structure” with “a cross-sectional inner diameter
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`… through which … stent catheters[] are insertable while the tubular structure is
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`located within the guide catheter.” Petitioner argues that “interventional
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`cardiology devices (e.g., PTCA balloons and stents) were insertable through the
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`lumen of Itou’s ‘flexible tip portion,’” Opp., 3 (citing “Ex. 2127, 2; Ex. 1902,
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`¶¶23-36”). But the cited evidence does not support that statement. Ex-2127 is a
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`GuideLiner development document that addresses only the size of the distal tube,
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`not obstructions caused by a pushwire. Unlike GuideLiner, Itou’s pushwire
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`1 Itou is not prior art, but Teleflex nevertheless addresses it substantively herein.
`2
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`obstructs access to its tubular lumen. Ex-2243, ¶55. The citation to Ex-1902,
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`¶¶23-36, appears to be an error. Ex-1902, ¶¶22, however, states that “[p]rotective
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`catheter (5) is insertable through tubular portion [and] flexible tip portion.” A
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`protective catheter is not a stent catheter. Petitioner’s expert further asserts that
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`“stents and stent catheters are also necessarily insertable” through Itou because
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`stents existed with outer diameters (bare crossing profiles) less than Itou’s effective
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`0.046 inch lumen diameter. Ex-1902, ¶22 (citing Ex-1806, §III(A)). A stent,
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`however, is a long, bulky, stiff device that requires space beyond its bare crossing
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`profile to move through a catheter, especially around bends in vessel anatomy or a
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`guide catheter. Ex-2243, ¶56. For that reason, manufacturers of the cited stents
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`require in their instructions for use a minimum 5 French (0.056 inches) catheter,
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`e.g., Ex-1802, 25 (the “minimal internal diameter of guiding catheter” for the 0.038
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`inch profile Tsunami stent is “0.056 inch, 5 Fr”)—far larger than Itou’s 0.046 inch
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`proximal opening. Ex-2243, ¶56. To the extent Petitioner relies on Ressemann,
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`adding Ressemann’s collar to Itou would only make the problem worse, by further
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`restricting the opening into Itou. Petitioner’s passing reference to Ressemann
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`cannot establish that a modified Itou device can pass a stent catheter because
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`Ressemann expressly states that, without a reverse bevel, “a stent delivery catheter
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`is particularly subject to hanging up.” Ex-1008, 25:27-29. Petitioner does not
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`address this teaching of Ressemann, nor does it provide a reverse bevel.
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`3
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`Petitioner’s failure to show that Itou, either in original or modified form, can pass
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`stents and stent catheters is fatal to its attack.
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`Size and “Coaxial” Limitations
`b.
`The asserted combination of Itou and Ressemann’s collar also fails to meet
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`claim 43’s requirements that (1) the system include “a standard 6 French guide
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`catheter … having a circular cross-sectional inner diameter of at least 0.070
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`inches” and a tubular structure “having a cross-sectional inner diameter of at least
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`0.056 inches,” and (2) that the tubular structure have “a coaxial lumen”:
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`2.2mm (.087”)
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`1.5mm
`(.059”)
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`1.72mm (.068”)
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`0.45mm (.018”)
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`Ex-2228 (dimensions from Ex-2239, 170:12-173:17).
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`2.
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`Substitute Claim 44
`a.
`Size and “Coaxial” Limitations
`As set forth above in Part III.A.1.b, Itou or Itou with Ressemann’s collar
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`does not meet claim 44’s (1) system with “a standard 6 French guide catheter
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`having … an internal diameter greater than or equal to 0.070 inches” and a “tubular
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`4
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`structure having a cross-sectional inner diameter of at least 0.056 inches,” or (2)
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`“the flexible tip portion … defining a coaxial lumen with the guide catheter.”
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`“Interventional Cardiology Devices Are Insertable”
`b.
`Claim 44 further recites a “tubular structure … through which the
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`interventional cardiology devices are insertable.” The application defines
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`“‘interventional cardiology devices’ … to include but not be limited to guidewires,
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`balloon catheters, stents, and stent catheters.” Ex-1003, 3:16-18 (emphasis added).
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`Petitioner’s expert agrees that this language means that “the invention here has to
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`be able to deliver stents [and] stent catheters.” Ex-2242, 85:21-86:21. Itou or Itou
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`with Ressemann cannot pass stents and stent catheters. See Part III.A.1.a.
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`Complex Side Opening
`c.
`Claim 44 further recites a complex side opening: “a first inclined sidewall
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`that is separated from a second inclined sidewall in the partially cylindrical portion
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`by a non-inclined concave track.” Teleflex’s claimed complex side opening is
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`important to the operation of the guide extension catheter for which Teleflex’s
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`invention created a market; that is why Petitioner and every other competitor
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`copied it. IPR2020-00128, POR, 50-57. Yet Petitioner does not point to a single
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`reference that has a complex proximal side opening, let alone such an opening that
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`one uses to receive interventional cardiology devices, let alone while inside a
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`guide catheter deep in the vasculature, let alone as part of a guide extension
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`5
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`catheter sized to closely fit within the guide catheter. Ressemann expressly taught
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`the difficulty of delivering devices such as stent catheters through a tube’s angled
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`opening: Without a reverse bevel not used in Petitioner’s combinations, “[s]tent
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`delivery catheters … are particularly subject to hanging up on the proximal end of
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`the evacuation head[’s angled opening].” Ex-1008, 25:27-29. Yet Ressemann’s
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`collar tab that Petitioner relies on so dearly is buried deep inside Ressemann’s
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`device, such that it has no role in shaping Ressemann’s side opening. Ex-2243,
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`¶¶58-51. And the shape at the distal end of Kataishi’s suction catheter has no
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`concave track, has a significantly different rigidity profile, and is for a completely
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`different purpose—improving suction by allowing that distal end to flex closer to
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`and about a thrombus. Ex-2243, ¶¶67-81. Petitioner transparently uses Teleflex’s
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`claims as roadmaps to pick and choose elements from disparate prior art, and then
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`uses hindsight to string them together.
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`Itou Plus Ressemann’s Collar
`i.
`Petitioner admits that Itou does not disclose claim 43’s complex side
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`
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`opening. Petitioner instead relies on Ressemann’s collar. But Ressemann’s own
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`device does not have a complex side opening. Ex-1008, Figs. 1A, 16A.
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`Petitioner’s proposed combination also fails because a POSITA would not
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`be motivated to myopically fixate on Ressemann’s support collar in the first place,
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`absent hindsight. Ex-2243, ¶¶58-66. The alleged first “inclined region”
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`6
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`(Ressemann’s collar’s tab 2141b’s tip) is buried inside shaft 2120 under many
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`layers of material. Id., ¶61. Unless using claim 43 as a roadmap, a POSITA would
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`not extract this lone component from Ressemann’s complex evacuation sheath
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`assembly (where it neither provides a first incline or concave track, nor performs
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`any guiding function for an interventional cardiology device) and use it as a
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`proximal opening in Itou’s structurally and functionally different suction catheter.
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`Petitioner’s original engineering expert admitted to using a hindsight-focused
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`approach when considering Ressemann, Ex-2137, 132:15-133:11 (“I’m not overly
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`concerned with what the collar was being done before I chose to use it .... I’m
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`more concerned about how I can use it in combination for what I want to do.”); see
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`also Ex-2116, 239:7-13. While Petitioner actively prevented its new engineering
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`expert from considering how Ressemann actually uses collar 2141, Ex-1807, ¶82
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`(“I have not been asked” to opine on “how collar 2141 is incorporated into
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`embodiment 2100.”), he nevertheless admits that his “opinions are not based on
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`how Ressemann is using the collar,” Ex-2239, 105:19-24, and that his proposed
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`use of the collar “is different than the way Ressemann, itself, teaches,” id., 105:25-
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`106:5. He also agreed that adding Ressemann’s collar to Itou would requires at
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`least six different modifications, further showing the hindsight nature of the
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`combination. Ex-2241, 51:23-53:1, 43:21-52:1; Ex-2243, ¶62. Because a POSITA
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`7
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`would not be motivated to select the support collar in the first place, the question
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`of how the support collar would be incorporated into Itou is moot.
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`Finally, Petitioner’s supposed motivations for adding Ressemann’s collar to
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`Itou cannot withstand scrutiny. Petitioner asserts that adding Ressemann’s collar
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`to Itou would “increase[] the area for receiving a stent and/or balloon catheter.”
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`Opp., 17. Either replacing Itou’s metal collar with Ressemann’s metal collar, or
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`merely grafting the collar on top, however, would decrease the cross-sectional area
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`of Itou’s tube opening. Ex-2243, ¶64. To the extent it was desired to increase the
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`area of Itou’s proximal opening, a POSITA simply could make Itou’s angle
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`shallower, Ex-2240, 157:4-5, 163:20-22, rather than extract a buried component
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`from an unrelated device and graft it onto Itou’s design. Ex-2243, ¶65. Petitioner
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`also asserts that Ressemann’s collar would “reinforce the proximal opening of the
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`catheter lumen, as well as provide a flexibility transition between the distal tubular
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`structure and the proximal shaft,” Opp., 17-18, but it fails to explain how
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`Ressemann’s metal collar would be better than Itou’s metal pipe for reinforcing the
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`tube’s opening, or why it would provide a flexibility transition superior to that of
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`Itou’s design. Ex-2243, ¶66. The flexibility transition provided by the collar tab is
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`specifically tailored to Ressemann’s Figure 16 embodiment, which has polymer
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`lumens in the shaft that must maintain their patency. Id. Itou has no such lumens
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`in its shaft, instead having a rigid weld between the metal tubular portion and metal
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`8
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`pushwire. Id. Further, Petitioner’s expert cannot say how the rigidity of Itou’s
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`metal pipe, or Itou’s pipe/wire weld, compares to that of Ressemann’s collar. Ex-
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`2240, 163:25-164:11. Petitioner’s final justification—Ressemann’s collar should
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`be used with Itou because both devices relate to “removing coronary vessel
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`occlusions,” Opp., 18—proves too much. It also ignores that Itou and Ressemann
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`are directed to fundamentally different purposes. Ex-2243, ¶60; see also Ex-2240,
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`169:21-170:9.
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`Itou Plus Kataishi’s Distal Tip
`ii.
`Kataishi does not disclose a tube’s proximal side opening, let alone a
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`complex side opening. The Board preliminarily concluded Petitioner failed to
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`“explain sufficiently why the inclined shape of Kataishi’s distal opening would
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`have been applicable to the angled partially cylindrical opening at the proximal end
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`of Itou’s suction catheter.” IPR2020-00135, Paper 22 at 23. That remains the
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`case. The primary purpose of the shape of Kataishi’s distal opening is to increase
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`suction by allowing the distal tip to flex and conform over a thrombus on a vessel
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`wall (“the concave portion helps to increase the flexibility of the distal tip of the
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`catheter,” Ex-2240, 104:2-5)—a purpose that is irrelevant to Itou’s rigid metal
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`proximal collar. IPR2020-00126, Ex-2138, ¶144; Ex-2145, ¶152.
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`Petitioner’s argument also fails because Kataishi does not disclose a non-
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`inclined concave track: Guidewire lumen 15 creates a ridge along the bottom of
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`9
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`the tube’s distal end. Ex-2243, ¶¶68-70; Ex-2240, 109:11-13. Kataishi Figures 2
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`and 12 show the guidewire lumen 15 running through the device’s distal tip, and
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`Figure 4 shows that guidewire lumen 15 creates a ridge along the bottom of the
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`tube. Ex-2240, 107:16-108:1. Sakurada appears to show this ridge. Ex-1055, Fig.
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`1A. Any argument by Petitioner that there is a concave track despite the guidewire
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`lumen’s longitudinal ridge would be nonsensical, and its expert’s speculation that
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`the guidewire lumen might be buried in the distal tip’s floor so that there is no
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`ridge finds no support in Kataishi. Kataishi undisputedly does not state that its
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`distal tip has a concave track, and creation of such a design, for example by adding
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`material to bury the guidewire lumen’s ridge, would be contrary to Kataishi’s
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`multiple statements that its distal tip is designed to be “flexible.” Ex-1025, ¶¶10,
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`26, 27, 28, claim 22; Ex-2243, ¶70. Because Kataishi does not teach a concave
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`track within the plain meaning of the term, much less a benefit or reason to provide
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`a concave track, it cannot be relied on to provide such a shape to Itou’s proximal
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`end.
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`Petitioner’s first and third alleged motivations to combine, “improved
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`crossability,” Opp., 20-21, make no sense, because Kataishi’s distal tip crosses
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`through the vasculature, while a guide extension catheter tube’s proximal end
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`remains in the guide catheter. Ex-2243, ¶¶74-77. Its alleged motivation of
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`“improved ability of an opening to accept material,” Opp., 20, ignores that
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`10
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`“Kataishi teaches enhancing suction by reducing the gap to better cover the
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`atheroma with the distal end of the suction catheter,” Ex-2240, 103:2-10; see also
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`Ex-1025, ¶27, which has no bearing on how the distal tip would perform if
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`positioned on a guide extension catheter within a guide catheter. Ex-2243, ¶78.
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`Petitioner’s last justification—Itou’s collar should be given the shape of Kataishi’s
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`distal tip because both references are directed to “removing occlusions from
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`coronary arteries using, inter alia, a catheter,” Opp., 21—again proves too much.
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`Instead, Kataishi teaches away from Teleflex’s claims: Its “[i]mproved flexibility
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`means the catheter can get [to] and cover the lesion,” which “enhances suction.”
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`Ex-2240, 105:24-106:7. But a POSITA would recognize that using Kataishi’s
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`deliberately-flexible distal tip structure on the proximal opening of a guide
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`extension catheter would present a kink point. Ex-2243, ¶81. Petitioner does not
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`explain just how Kataishi is being combined with Itou—for example, is the shape
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`of Kataishi being cut into Itou’s pipe, is Kataishi’s distal end being grafted onto
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`Itou’s tube and how, etc. Petitioner also does not attempt to reconcile Kataishi’s
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`teaching that the distal tip’s shape is for “improving flexibility of the catheter distal
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`end,” Ex-1025, ¶27, with Itou’s opposite teaching that the pipe’s “proximal end
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`portion 231 is secured firmly by being welded to the distal end of the wire-like
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`portion,” Ex-1007, 4:33-34, to provide enough strength for the suction catheter to
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`“be rotated, pushed or pulled,” id., 7:20-24. These conflicting motivations would
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`11
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`prevent a POSITA from putting Kataishi’s distal tip on Itou’s proximal tube
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`opening. Ex-2243, ¶¶76, 81-82.
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`B.
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`Substitute Claims 43 and 44 Are Patentable Over Kontos in View
`of Ressemann and Takahashi
`1.
`Substitute Claim 43
`a.
`“Stent Catheters … Are Insertable”
`Petitioner does not appear to address claim 43’s requirement that the device
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`be capable of passing stent catheters. Its expert only references Kontos’s ability to
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`deliver a PTCA catheter (Ex-1902, ¶149), which is insufficient to establish that
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`Kontos’s tube is capable of receiving a stent catheter. Part III.A.1; Ex-2243, ¶¶84-
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`86. Petitioner’s passing reference to Ressemann cannot establish that the modified
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`Kontos device can pass a stent catheter because Ressemann expressly states that,
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`without a reverse bevel, “a stent delivery catheter is particularly subject to hanging
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`up.” Ex-1008, 25:27-29. Petitioner does not address this teaching of Ressemann,
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`nor does it provide a reverse bevel.
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`b.
`
`0.056 Inch Inner Diameter Tube in a 6 French Guide
`Catheter
`The system claimed in claim 43 includes “a standard 6 French guide
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`catheter” with an “inner diameter of at least 0.070 inches,” and a tubular structure
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`with an “inner diameter of at least 0.056 inches.” Tacitly admitting that its prior
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`modifications to Kontos were not extensive enough to meet Teleflex’s claims,
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`Petitioner now relies on an entirely newly created device, allegedly based on
`12
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`Kontos, that bears little resemblance to the device actually disclosed in Kontos.
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`This is evident from comparing Kontos’s Figure 1 (Ex-1009) with Petitioner’s
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`creation (Opp., 19). Petitioner’s expert testified that, to transform Kontos’s device
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`into the device Petitioner now relies on for claim 43, Petitioner had to make at
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`least ten (10) changes to Kontos: Ex-2240, 130:19-131:2; 130:3-6; 135:1-3,
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`139:20-24; 134:24-25, 94:14-18; 134:11-15; 134:21-23, 136:6-18; 148:5-9; 136:4-
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`6; 137:5-13, 39:1-18; 156:4-6. Ex-2243, ¶¶90-91. The sheer extent of changes
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`Petitioner must make to Kontos is compelling evidence that the changes are based
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`on improper use of Teleflex’s claims as blueprints. See, e.g., Campbell Soup Co. v.
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`Gamon Plus, Inc., 939 F.3d 1335, 1341-42 (Fed. Cir. 2019) (“significant
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`modifications would first need to be made to [the prior art] design”); Ashley
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`Furniture Indus. v. Lifestyle Enter., 574 F. Supp. 2d 920, 933 (W.D. Wis. 2008)
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`(primary reference “would require a number of significant changes, including
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`major modifications to the structure”); Datascope Corp. v. Kontron, Inc., 611 F.
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`Supp. 889, 892-93 (D. Mass. 1985) (prior art “needed significant alterations before
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`it would have resembled” invention). Indeed, another of Petitioner’s experts
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`admits he “was asked to come up with all things that could be done to produce
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`basically what is shown in” the new design, Ex-2241, 141:18-21—the epitome of
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`hindsight.
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`
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`13
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`
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`Petitioner’s newly created device also would not work for Kontos’s stated
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`purposes. It no longer would function as a “support catheter” for a catheter prone
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`to kinking, nor could it cross a lesion to function as a temporary stent. Ex-2240,
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`71:23-25; id., 71:16-22. Ex-2243, ¶¶103-108. Kontos’s eccentric base section 18
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`served an important purpose, providing “leverage for facilitating manipulation of
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`body 12,” Ex-1009, 4:34-38, and “attaching the application wire to the base portion
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`18 provides a secure connection between the wire and the tube,” Ex-2240, 96:4-10.
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`Petitioner does not explain why a POSITA would eliminate this important aspect
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`of Kontos’s device. Its new argument that a POSITA would be motivated to
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`“taper” the relatively thick 0.020 inch pushwire to fit into a 0.005 inch thick
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`sidewall contradicts Petitioner’s arguments about Itou, where it contends a
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`POSITA would add material (Ressemann’s collar) where the pushwire meets the
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`tubular portion to address a “potential weakness point in the catheter.” IPR2020-
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`00135, Paper 82, 17. Petitioner’s new engineering expert has not “identified any
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`prior art where a wire is tapered down to .005 inches,” Ex-2241, 49:2-6, and
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`another confirms that “the push wire can’t be flimsy,” Ex-2240, 85:15. A POSITA
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`in 2005 would have been concerned that the wire, tapered to less than 0.005 inches
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`so it can fit into Kontos’s sidewall, may have been too flimsy to advance the
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`device, even with any help from Ressemann’s tab. Ex-2243, ¶105. Ressemann’s
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`0.002 inch thick tab has more window than metal at its proximal end. Id. While
`
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`14
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`
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`making the wire more flexible, Petitioner also enlarges and makes more rigid the
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`tube, which would only make it more difficult to advance Petitioner’s new device.
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`Id.
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`Petitioner does not explain how a POSITA would redesign Kontos’s tip
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`structure, see Ex-1807, ¶¶168-82, recess marker band 36 in the extremely thin
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`(0.005”) wall of the tube 16, Ex-1800, 194:19-197:24, or attach/bind soft tip
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`portion 28 without the overlapping material shown in Kontos. Ex-2243, ¶106.
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`Petitioner’s newly created device would not work even as a guide extension
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`catheter. In addition to the pushability problem caused by the narrow end of the
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`pushwire, the design presents a catch-point for stents: Petitioner would mount
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`Ressemann’s collar tab on top of the pushwire, so that it is spaced apart from the
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`guide catheter’s wall at least by “the thickness of the wire underneath the tab
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`portion of the collar,” “the wall thickness of the tube,” and potentially by the “gap
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`between the outer diameter of the tube and the inner diameter of the guide
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`catheter.” Ex-2240, 148:1-18. As a result, the metal edges of the collar extend
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`upwardly into open space within the guide catheter, creating an obstruction and
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`catch point for advancing interventional cardiology devices—especially stent
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`catheters, which claim 43 expressly recites the claimed system must be able to
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`deliver. Ex-2243, ¶107.
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`15
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`
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`Petitioner relies on Takahashi as alleged motivation to create its new device.
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`Opp., 22-23. Kontos’s device, however, already fit into a 6 French guide catheter,
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`and Petitioner already alleges that Kontos provides backup support. Ex-2243,
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`¶112. Enlarging Kontos’s tube would make it unsuitable for its intended purposes,
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`as discussed above. Petitioner’s modification are based solely on hindsight.
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`c.
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`“Coaxial Lumen,” “Uniform, Fixed” Outer Tube
`Diameter, and "Flexible Cylindrical Reinforced
`Portion”
`Claim 43 further recites that “the tubular structure ha[s] a uniform, fixed
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`cross-sectional outer diameter,” that it defines “a coaxial lumen,” and that there’s a
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`“flexible cylindrical reinforced portion.” Several of Petitioner’s at least ten
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`changes to Kontos are required for the newly created device to meet these
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`limitations, further establishing that Petitioner’s many changes are hindsight-
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`driven.
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`2.
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`Substitute Claim 44
`a.
`“Coaxial” Lumen Through Which “Interventional
`Cardiology Devices Are Insertable”
`Substitute claim 44 recites a flexible tip portion that defines a “coaxial
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`lumen,” one “through which … interventional cardiology devices are insertable.”
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`Petitioner has failed to establish that Kontos has a coaxial lumen, or one that can
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`pass interventional cardiology devices, which must include stent catheters. See
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`Part III.B.1.a.
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`
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`16
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`
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`b.
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`0.056 Inner Diameter Tube in a 6 French Guide
`Catheter
`Claim 44, like claim 43, recites a system that includes “a standard 6 French
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`guide catheter” with “an internal diameter greater than or equal to 0.070 inches,”
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`and a “tubular structure” with an “inner diameter of at least 0.056 inches.”
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`Petitioner has failed to establish that new Kontos-based arguments render claim 43
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`unpatentable because of these size limitations. See Part III.B.1.b.
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`Complex Side Opening
`c.
`Kontos does not disclose a side opening at all, much less the complex side
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`opening of claim 44. As with Itou, Petitioner uses hindsight to argue that it would
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`have been obvious to add Ressemann’s Figure 16 collar to Kontos in a way that
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`results in the claimed complex opening. As discussed above, Part III.A.2.c.i, the
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`alleged first “inclined region” (Ressemann’s collar’s tab 2141b’s tip) is buried
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`inside Ressemann’s device and serves no purpose whatsoever in that device. It is
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`only with the benefit of hindsight that a POSITA would give any thought to re-
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`purposing Ressemann’s collar in Kontos in the manner argued by Petitioner.
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`Petitioner’s motivations are not only hindsight-based, they are contrary to
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`the teaching of Kontos. Petitioner argues that removing Kontos’s funnel and
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`adding Ressemann’s collar would “optimize the inner diameter of tube 16.” Opp.,
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`19. Increasing the inner diameter of Kontos’s tube 16, however, runs counter to
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`Kontos’s stated purposes of acting as a temporary stent, which requires crossing a
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`
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`17
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`
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`lesion, Ex-2240, 140:16-141:8, and of functioning as a “support catheter” that fits
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`closely over a catheter that is susceptible to kinking. E.g., Ex-2243, ¶113;
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`IPR2020-00130, POR, 11-12, 26, 29; Ex-1009, 4:61-62, 5:20-22, Figs. 5-9 (which
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`Petitioner’s expert admits show a snug-fitting support catheter, Ex-2241, 119:15-
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`19); Ex-2240, 82:16-18. Petitioner’s argument also is unpersuasive, because a
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`POSITA would not believe removing Kontos’s funnel would increase the tube’s
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`interior diameter in view of Kontos’s raised marker band and base portion.
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`IPR2020-00127, Ex-2138, ¶¶155-58. Petitioner’s other supposed Ressemann-
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`based motivations are without basis. Further, Petitioner relies on statements
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`comparing a side opening to a bare perpendicular opening—one without a funnel.
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`Kontos already has a funnel and therefore provides “smoother” passage.
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`Ressemann teaches that a side opening has increased hang-up risks compared to a
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`funnel. Ex-2243, ¶100; Ex-1008, 25:20-29. Thus, there is no motivation to
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`remove Kontos’s funnel to obtain that same benefit but with the added risk of
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`catching/hang-up. E.g. In re Schweickert, 676 F. App’x 988, 995-96 (Fed. Cir.
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`2017). Also regarding “smoother passage of the catheter assembly as it navigates
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`the vasculature,” Petitioner fails to weigh any such negligible benefit against the
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`importance of Kontos’s funnel to its disclosed functions. Kontos’s funnel is
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`important because it decreases the likelihood of devices getting caught/hung-up on
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`the proximal opening. IPR2020-00130, POR, 29. Indeed, notwithstanding
`
`
`
`18
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`
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`Petitioner’s criticisms of Kontos’s funnel and its assertions that angled openings
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`were known by 1994, its expert admits that, not only is “an angled opening … not
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`suggested in Kontos,” Kontos’s patent “has claims that are directed to the use of a
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`funnel with his device.” Ex-2240, 74:13-75:3. Finally, all experts agree a
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`POSITA would never push Kontos’s support catheter all the way out of the guide
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`catheter; indeed, Kontos provides its funnel in part to prevent that. Ex-1009, 6:1-2;
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`Ex-2243, ¶102.
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`Substitute Claim 44 Is Patentable Over Kontos and Kataishi
`C.
`Petitioner includes a throwaway argument at the end of its brief, asserting
`
`without analysis that, “[f]or reasons similar to those discussed above …, a POSITA
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`would have found it obvious to replace Kontos’s flared opening with a double-
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`inclined opening like in Kataishi.” Opp., 25-26. For the reasons set forth above,
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`the Board shoul