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