`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`
`Petitioners,
`
`v.
`
`TELEFLEX LIFE SCIENCES LIMITED,
`
`Patent Owner.
`_____________________________
`
`Case No.: IPR2020-01344
`U.S. Patent No. RE 46,116
`______________________________
`
`PETITIONERS’ REPLY
`
`
`
`
`

`

`TABLE OF CONTENTS
`
`4.
`
`5.
`
`2.
`3.
`
`Page
`I.
`Introduction ...................................................................................................... 1
`Kontos’s Extension Catheter Is Not a Narrow Tube. ...................................... 1
`II.
`III. The Asserted claims are Obvious. ................................................................... 3
`A.
`The Kontos-Ressemann combination teaches the single-incline and
`double-incline side openings of the ʼ116 patent. .................................. 3
`1.
`Replacing Kontos’s funnel with a side opening maximizes the
`usable area in the catheter assembly. .......................................... 4
`Petitioner’s other motivations are not based in hindsight. .......... 7
`Replacing Kontos’s funnel with a side opening would not create
`a problematic gap. ....................................................................... 9
`A POSITA had a reasonable expectation of success when
`replacing Kontos’s funnel with Ressemann’s collar. This
`combination creates a two-incline side opening. ......................11
`Even if a POSITA placed Ressemann’s collar underneath the
`pushrod, the Kontos-Ressemann combination still teaches the
`single-incline and double-incline openings. .............................13
`Claim 32: After replacing the funnel with a side opening, support
`catheter 10 would remain coaxial with the GC. ..................................16
`Claims 25-40, 42, and 44-48: Kontos-Ressemann-Takahashi
`combination teaches the not-more-than-one-French limitation. .........17
`The Kontos-Ressemann-Kataishi combination teaches a double-
`inclined side opening. ..........................................................................19
`IV. Root is Prior Art and Renders the Claims Obvious .......................................23
`V.
`SECONDARY CONSIDERATIONS DO NOT OVERCOME
`OBVIOUSNESS. ...........................................................................................25
`A.
`Teleflex is not entitled to a presumption of nexus. .............................25
`B.
`Teleflex’s secondary consideration evidence all relates to prior art
`features and functionality. ...................................................................27
`1.
`Teleflex’s alleged evidence of copying is actually copying of
`the prior art. ...............................................................................29
`2. Medtronic did not copy GuideLiner. ........................................30
`VI. CONCLUSION ..............................................................................................31
`
`B.
`
`C.
`
`D.
`
`ii
`
`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Butamax Advanced Biofuels LLC v. Gevo, Inc.,
`IPR2013-00539, 2015 WL 1263027 (PTAB Mar. 3, 2015) ............................... 23
`Dr. Reddy’s Labs. S.A. v. Indivior UK Ltd.,
`IPR2019-00329, 2019 WL 2361782 (PTAB June 3, 2019) ............................... 23
`Fox Factory, Inc. v. SRAM, LLC,
`944 F.3d 1366 (Fed. Cir. 2019) .......................................................................... 26
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .................................................................... 29, 30
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) .................................................................... 29, 30
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) .......................................................................... 25
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 28
`
`
`
`iii
`
`

`

`I.
`
`INTRODUCTION
`Patent Owner (“PO”) does not dispute, because it cannot, that Kontos
`
`describes its “support catheter” as a “mini guide catheter.” Ex-1409, 3:40-49. Nor
`
`does PO dispute that Kontos teaches, just like the coaxial guide catheter 12 of the
`
`Teleflex patent, that support catheter 10 includes a short distal lumen (body 12)
`
`coupled to a pushrod (wire 14). Kontos also describes the method of passing the
`
`support catheter “further through the coronary ostia than can guide catheter 38” to
`
`function as a “guide extension catheter” when “extending beyond the distal end of
`
`guide catheter 38” to help prevent a PTCA balloon catheter from bending,
`
`buckling, or kinking en route to treat a lesion. Other than the various side openings,
`
`Kontos teaches each structural limitation of the Challenged Claims. But as
`
`explained herein, the use of the claimed side openings was an obvious modification
`
`from several pieces of prior art—including Ressemann, which the Board already
`
`found anticipated similar claims in other IPRs. The challenged claims in this IPR
`
`are likewise invalid as obvious.
`
`II. KONTOS’S EXTENSION CATHETER IS NOT A NARROW TUBE.
`PO argues that Kontos’s body 12 must be a “narrow tube” because it “is
`
`important for Kontos to provide these functions” of protecting a balloon catheter,
`
`crossing a lesion, or acting as a temporary stent. Patent Owner Response (POR),
`
`Paper 91, 22. PO is wrong. Ex-1806 ¶¶99-106; Ex-1807 ¶¶113-17. Kontos never
`
`1
`
`

`

`states that it is “important” for body 12 to be “narrow” or have a “snug fit.” Ex-
`
`1806 ¶¶101-02; Ex-1801, 52:5-8 (language is silent concerning “snugness”);
`
`Ex-1800, 77:6-11, 78:12-20. In fact, Kontos teaches the opposite, explaining that
`
`the size of body 12 should be suitable “for existing PTCA catheters” and that “[o]f
`
`course, other sizes may be used for other applications.” Ex-1409, 4:46-48, 4:61-
`
`5:2.
`
`PO’s argument is also contradicted by how Kontos actually prevents kinking
`
`of the PTCA catheter. Ex-1806 ¶103; Ex-1807 ¶¶14-27, 113-17. Kontos prevents
`
`kinking by reducing the distance between the distal-most portion of the catheter
`
`assembly and the occlusion. Ex-1806 ¶103; Ex-1807 ¶¶20-21, 117. “[B]ody 12
`
`functions as a guide catheter extension,” by reducing “the gap that PTCA catheter
`
`40 must negotiate without assistance …, [which] lessens considerably the tendency
`
`of the PTCA catheter 40 to bend, buckle or kink.” Ex-1409, 5:49-56. This is
`
`because, by comparison to advancement within the vasculature, significantly less
`
`force is needed to advance the interventional cardiology device (“IVCD”) within
`
`body 12 due to its lubricious inner coating. Ex-1806 ¶103; Ex-1807 ¶¶20-21, 117;
`
`Ex-1813, 52:14-53:8, 72:24-73:14. It is Kontos’s ability to shorten the distance that
`
`the IVCD traverses in the vasculature—especially in regions that are not straight or
`
`heavily calcified—and not the spatial relationship with the IVCD that reduces the
`
`likelihood of kinking. Ex-1806 ¶103; Ex-1807 ¶¶20-21, 117.
`
`2
`
`

`

`This conclusion is buttressed by the real-world experience of PO’s expert.
`
`Dr. Graham testified that he has never had an IVCD kink within a catheter
`
`assembly. Ex-1813, 52:14-53:8. In other words, the closeness of support assembly
`
`10 and the PTCA catheter 40 is irrelevant, as kinking (if it does occur) would not
`
`happen until the IVCD is in the vasculature. Ex-1806 ¶103-04.
`
`Not only is a close-fitting tube unnecessary to prevent kinking of the PTCA
`
`catheter, but, as Dr. Brecker explains, it would be detrimental. Ex-1806 ¶102. If the
`
`relationship is too “snug,” the IVCD can be damaged when loaded into the
`
`extension catheter, especially post-expansion, when the PTCA balloon is retracted
`
`proximally into the extension catheter. Id.
`
`Finally, even if Kontos taught a small body 12 with a “snug fit” to the
`
`IVCD, PO’s argument still fails because it is premised on Kontos’s invention being
`
`limited to fixed-wire catheters. Ex-1800, 76:2-8, 80:12-81:17; Ex-1801, 56:1-10,
`
`60:16-21. Kontos is not so limited, and instead provides that “the device of this
`
`present invention may be used with almost any type of catheter, including over-
`
`the-wire catheters.” Ex-1409, 9:47-50; Ex-1806 ¶¶105-06.
`
`III. THE ASSERTED CLAIMS ARE OBVIOUS.
`A. The Kontos-Ressemann combination teaches the single-incline
`and double-incline side openings of the ʼ116 patent.
`A POSITA was motivated, with a reasonable expectation of success, to
`
`replace Kontos’s proximal funnel with Ressemann’s support collar 2141
`
`3
`
`

`

`(“Ressemann’s collar”). Petition (Pet.), Paper 1, 15-32. Replacing Kontos’s
`
`proximal funnel with Ressemann’s support collar 2141 results in a proximal
`
`opening with two inclines. Pet., 51-53. PO’s entire opposition is based on the
`
`mistaken belief that after adding Ressemann’s collar, a POSITA would make no
`
`further modification to Kontos’s support assembly 10. Even if a POSITA made no
`
`further modifications, though, PO’s argument still fails.
`
`1.
`
`Replacing Kontos’s funnel with a side opening maximizes
`the usable area in the catheter assembly.
`Replacing Kontos’s proximal funnel with a side opening maximizes the
`
`usable real estate within the catheter assembly. Ex-1806 ¶115. This is particularly
`
`important given that catheter assemblies used in PCI procedures are “not much
`
`bigger than a toothpick.” Ex-2137, 199:11-200:16. PO’s expert agrees that
`
`“maximizing the usable real estate inside a guide catheter is extremely important.”
`
`Ex-2145 ¶90; Ex-1801, 102:2-8; Ex-1813, 91:18-92:5. Specifically, PO’s expert
`
`testified that it was “important” to “maximize the inner diameter of the extension
`
`catheter without having to increase the outer diameter of the guide catheter.”
`
`Ex-1801, 102:2-8; Ex-2138 ¶266. And PO’s expert agreed that the use of a
`
`proximal funnel does not maximize the useable “real estate” within the catheter
`
`assembly. Ex-1813, 92:19-24.
`
`
`
`
`
` Ex-1851, 296:23-297:1.
`
`4
`
`

`

`a. Maximizing usable real estate: reducing diameter of GC.
`Replacing Kontos’s funnel with a side opening, reduces the outer diameter
`
`of the extension catheter, which permits the use of a smaller-diameter GC.
`
`
`
`Ex-1405 ¶211. PO does not disagree, but instead argues that a POSITA would not
`
`replace the funnel with a side opening because Kontos was already sized to fit
`
`inside a 6 French GC and that a 5 French GC offered no advantage. POR, 21-22.
`
`Kontos has a 0.065-inch outer diameter at base portion 18 (Ex-1409, Fig. 3),
`
`meaning that to fit inside a 6 French GC having a 0.070-inch inner diameter,
`
`Kontos’s funnel would only have a 0.005 inch profile. Ex-1807 ¶¶120-21. This
`
`would provide no—or significantly limit the—funneling function. Id., ¶121.
`
`Further, even at 0.005 inches, the funnel would “rub” in a 6 French GC, which, as
`
`admitted by PO’s expert, would “hinder the ability to facilitate smooth passage.”
`
`Ex-1801, 115:14-117:7. Thus, replacing Kontos’s funnel with a side opening
`
`would improve the trackability within the GC. Ex-1806 ¶124. Further, a POSITA
`
`5
`
`

`

`was motivated to use a side opening because it would more easily permit
`
`compatibility with a 5 French GC, which has advantages over a 6 French GC.1 Id.,
`
`¶125.
`
`b. Maximizing usable real estate: increasing diameter of
`extension catheter.
`The corollary is also true: a POSITA would be motivated to replace
`
`Kontos’s funnel with a side opening because the inner diameter of body 12 could
`
`then be increased without similarly increasing the diameter of the GC. Ex-1405
`
`¶¶163-64.
`
`
`
`Ex-1405 ¶164. A POSITA was motivated to make this modification, as PO’s
`
`expert acknowledged, because “the larger the available area within a guiding
`
`device, the larger the variety of types, numbers and sizes of therapeutic devices
`
`
`1 For compatibility with a 5 French GC, tube 16 would be molded onto tapered
`
`wire 14. § III.C, infra.
`
`6
`
`

`

`that can be delivered.” Ex-2145 ¶140. Doing so, “ultimately improves the available
`
`treatment options for the patient.” Id.; Ex-1813, 132:22-133:10.
`
`Despite its own expert agreeing to the advantages of increasing the diameter
`
`of the extension catheter without causing a commensurate increase in the GC, PO
`
`argues that a POSITA would not apply this teaching because Kontos requires a
`
`close fitting. POR, 22. But for the reasons discussed above, Kontos does not
`
`mandate such a tight fit. § II, supra.
`
`PO also argues that it would not be possible to increase the diameter of body
`
`12, without also increasing the diameter of the GC, due to Kontos’s raised marker
`
`bands. POR, 26-27. Kontos teaches, however, that “[o]f course, numerous other
`
`methods for disposing marker band 30 at distal end 24 will be readily apparent to
`
`those skilled in the art.” Ex-1409, 4:21-24. Embedded marker bands were routine
`
`in the art. Ex-1806 ¶119; Ex-1762, 56:9-23. PO’s expert agreed. Ex-1801, 66:19-
`
`67:6, 70:5-17, 75:15-19. It was well within the skill of a POSITA to recess
`
`Kontos’s marker bands. Ex-1807 ¶¶128-36. PO cannot defeat Petitioners showing
`
`that a POSITA would replace Kontos’s funnel with Ressemann’s collar.
`
`Petitioner’s other motivations are not based in hindsight.
`2.
`A POSITA was also motivated to replace Kontos’s funnel with Ressemann’s
`
`collar, as it would increase the area of entry—by more than five-fold—into the side
`
`opening. Ex-1807 ¶141. PO’s expert agreed:
`
`7
`
`

`

`Even though [Kontos is] funneled, the opening is perpendicular …. And
`I’ve have agreed on record that an angled opening gives you a greater
`surface area than a perpendicular one …. With the -- the combination,
`using the -- the angled opening at 2141 tab from Ressemann compared
`to what Kontos has originally described … would increase the opening
`area into … Kontos. It would increase the area.
`
`Ex-1801, 120:16-121:13.
`
`Further, Ressemann teaches that “[t]he proximal end 2140a of the
`
`evacuation lumen 2140 is preferably angled to facilitate smooth passage of other
`
`therapeutic devices through the evacuation lumen 2140 of the evacuation head
`
`2132.” Ex-1408, 23:17–20; see also id., 6:52-60. Despite this clear teaching, PO
`
`argues that side openings actually cause device “catching/hang up issues.” POR,
`
`16-17. This argument, though, is contradicted by a patent (“Keith”) issued to PO’s
`
`own expert, which contains Ressemann’s verbatim disclosure of side openings
`
`“facilitate[ing] smoother passage” of IVCDs. Ex-1123, 7:54-60; Ex-1800, 149:3-
`
`10. PO cannot maintain its argument that a side opening causes device hang-up,
`
`given its own expert obtained a patent reciting the benefits of side openings
`
`allowing smoother passage of interventional cardiology devices.
`
`Side openings also allow for smoother passage of the catheter assembly as it
`
`navigates the vasculature. Pet., 22. PO argues, though, that this teaching is
`
`“unsupported by the evidence.” POR, 18. PO is wrong. Not only does Ressemann
`
`explicitly state that a side opening “allow[s] for smoother passage of the
`
`8
`
`

`

`evacuation sheath assembly 100 through a guide catheter,” but an identical
`
`teaching is also recited in Keith. Ex-1123, 7:54-60.
`
`
`
`
`
` Ex-1819 ¶112.
`
`Finally, a side opening permits smooth re-entry when the extension catheter
`
`is extended beyond the distal end of the GC. Pet., 23-24. PO’s expert previously
`
`found himself in that situation (i.e., passed an extension catheter entirely outside of
`
`the GC),2 Ex-1801, 72:10-73:18, and agreed that a proximal opening, as opposed
`
`to Kontos’s funnel, permits smoother re-entry of the extension catheter. Ex-1801,
`
`79:14-21; Ex-1800, 151:17-152:1.
`
`3.
`
`Replacing Kontos’s funnel with a side opening would not
`create a problematic gap.
`Despite the clear teachings for why a POSITA would replace Kontos’s
`
`funnel with a side opening, PO argues that doing so would actually cause
`
`problems. POR, 13-18. First, PO’s argument fails because it is based on a false
`
`premise that a POSITA would not maximize the usable real estate in the catheter
`
`
`2 PO is incorrect to argue that “Kontos teaches that generally it is not desirable to
`
`extend the proximal end of body 12 beyond the distal end of the guide catheter.”
`
`POR, 24. PO ignores Figure 7, which teaches the intentional advancement into the
`
`vasculature. Ex-1409, 6:19-28, Fig. 7.
`
`9
`
`

`

`assembly. As explained above, a POSITA would have done so. § III.A.1, supra.
`
`Even assuming a POSITA made no further modifications after replacing the funnel
`
`with a side opening, Kontos would not create a “problem gap” as alleged by PO.
`
`If Kontos was used with a 6 French GC, the gap between the support
`
`assembly’s outer wall and the inner wall of the GC would be 0.005 inches. Given
`
`that a guidewire or the distal-most wire of a fixed-wire balloon typically have a
`
`0.014 inch diameter, the PTCA catheter would not catch in the gap between tube
`
`16 and the inner wall of the GC. Ex-1806 ¶¶ 120-25.
`
`
`
`Ex-1409, Fig. 1 (modified by Petitioner).
`
`Ressemann and Keith buttress this conclusion. Ex-1806 ¶124. Both
`
`references teach side openings that are “preferably angled” to “facilitate smoother
`
`passage of other therapeutic devices,” and both teach a gap of at least 0.009 inches
`
`as shown below. Id., ¶125. This is almost double Kontos’s alleged “problematic”
`
`gap. Id.
`
`10
`
`

`

`
`
`Ex-1123, Fig. 1A (annotations added). For these additional reasons, a POSITA
`
`would replace Kontos’s funnel with Ressemann’s collar. Ex-1806 ¶125.
`
`4.
`
`A POSITA had a reasonable expectation of success when
`replacing Kontos’s funnel with Ressemann’s collar. This
`combination creates a two-incline side opening.
`PO also argues no reasonable expectation of success to integrate
`
`Ressemann’s collar with Kontos. POR, 41-42. Specifically, PO argues that the
`
`proposed modification would (i) create a catch point and (ii) not be
`
`“straightforward.” Id. Both arguments fail.
`
`In support of its argument that the proposed modification would create a
`
`catch-point, PO presents the following schematic.
`
`11
`
`

`

`
`
`Id., 41. It was standard practice in the art—including, as explicitly taught by
`
`Ressemann (Ex-1408, 7:28-39, 24:2-11)—to encase Ressemann’s collar in a
`
`polymer jacket to remove any catch points. Ex-1807 ¶¶142-44. In so doing, as
`
`shown in the below schematic, the proposed modification would eliminate any
`
`concern about creating a problematic catch-point.
`
`Id.
`
`Further, Ressemann’s collar could have been attached to Kontos’s wire 14,
`
`
`
`12
`
`

`

`as taught by Ressemann, with a thin layer of solvent casting. Ex-1807 ¶¶69-71,
`
`144-45; Ex-1408, 24:2-11. Doing so would have maintained the proximal incline
`
`of Ressemann’s collar. Ex-1807 ¶159. Thus, PO is incorrect to argue no
`
`expectation of success. Accordingly, the Kontos-Ressemann combination teaches
`
`both the single-incline and two-incline proximal openings recited in the ʼ116
`
`patent. Ex-1806 ¶133-39.
`
`
`
`Ex-1409, Fig. 1 (modified by Petitioner).
`
`5.
`
`Even if a POSITA placed Ressemann’s collar underneath
`the pushrod, the Kontos-Ressemann combination still
`teaches the single-incline and double-incline openings.
`PO states that GuideLiner version 1 has three inclines, which means that
`
`Ressemann must also have at least three inclines. Ex-1806 ¶¶86-91. Therefore,
`
`even if Ressemann’s collar was placed underneath Kontos’s pushrod—as alleged
`
`by PO—the Kontos-Ressemann combination still teaches a two-inclined opening.
`
`Ex-1806 ¶¶137-39.
`
`13
`
`

`

`PO’s expert testified that he identifies where one incline ends and another
`
`begins “just sort of by eye,” explaining that for version 1 of GuideLiner, as
`
`identified below, incline 1 has a “relatively steeper quality” to it, and incline 2 has
`
`“a shallower quality” to it, and “somewhere in between there” is incline 3.
`
`Ex-1800, 45:21-46:2. He believes that even shallow inclines are inclines so long as
`
`they can be identified relative to the catheter’s longitudinal axis. Id., 46:21-47:8.
`
`Ex-1122 (color added to arrows for visibility). Similarly, Root testified that the
`
`figure below has two inclines separated by a flat section. Ex-1762, 91:24-94:1.
`
`
`
`14
`
`

`

`Ex-1854 (bottom annotation added to show inclined regions (red) and flat region
`
`
`
`(blue)).
`
`In light of PO’s testimony, Ressemann’s collar must have more than two
`
`inclines. As shown below, Ressemann’s collar has an incline at the proximal end
`
`(“A”), an incline corresponding to the curve between 2121a and 2141b (“C”), and
`
`an incline at the curved portion of tab 2141b (“B”). Ex-1806 ¶¶136-38.
`
`
`
`15
`
`

`

`Therefore, even if a POSITA placed the tab of Ressemann’s collar under
`
`wire 14, the resulting Kontos-Ressemann combination would still have two
`
`inclines. Ex-1806 ¶¶138-39 (identifying B and C).
`
`
`
`Ex-1807 ¶158.
`
`B. Claim 32: After replacing the funnel with a side opening, support
`catheter 10 would remain coaxial with the GC.
`PO next argues that after replacing the funnel with a side opening, the lumen
`
`of tube 16 and the GC would not be coaxial. PO’s argument fails because it
`
`requires an overly-exacting definition of coaxial. Even under PO’s construction,
`
`Kontos is coaxial.
`
`As used in the Teleflex patents, “coaxially aligning” means that “the axis of
`
`the lumen of the guide extension catheter is aligned in the same direction as the
`
`axis of lumen of the guide catheter.” Ex-1806 ¶¶126-28. Under this definition,
`
`Kontos remains coaxial if its proximal funnel is replaced by a side opening. Ex-
`
`1806 ¶¶126-27. PO argues that coaxial means that the lumens must be perfectly
`
`concentric, such that any deviation off axis—as shown below—does not meet the
`
`claim limitation.
`
`16
`
`

`

`
`
`POR, 31. Even if PO is correct, Kontos is still coaxial. Ex-1806 ¶28. Specifically,
`
`Kontos teaches that “tube 16 may be molded directly onto application wire 14.”
`
`Ex-1409, 4:31-32. In such a scenario, there would be no need for receiving hole 34
`
`in base portion 18. Ex-1807 ¶¶131-34. A POSITA would be motivated to taper
`
`wire 14 for attachment to tube 16, because this would optimize Kontos by either
`
`permitting (i) use with a 5 French GC or (ii) a larger diameter for body 12.
`
`§ III.A.1, supra.
`
`C. Claims 25-40, 42, and 44-48: Kontos-Ressemann-Takahashi
`combination teaches the not-more-than-one-French limitation.
`PO does not dispute that Takahashi provides motivation to achieve a 1
`
`French differential to increase back-up support. Ex-1801, 117:14-118:5. PO argues
`
`that this motivation is inapplicable, though, because Kontos “teaches away from
`
`maximizing the inner diameter.” POR, 26. As discussed above, PO is incorrect to
`
`argue that Kontos requires a snug fitting body 12. § II, supra. Thus, a POSITA was
`
`17
`
`

`

`motivated to apply the teachings of Takahashi to increase back-up support. Ex-
`
`1806 ¶¶129-32.
`
`PO also argues that a POSITA would not have an expectation of success to
`
`modify Kontos to achieve the 1 French differential. POR, 41. PO is wrong. A
`
`POSITA knew how to (i) replace the proximal funnel with a side opening and (ii)
`
`recess Kontos’s distal marker bands. § III.A.1.b, supra. Further, Kontos explicitly
`
`teaches that “tube 16 may be molded directly only application wire 14.” Ex-1409,
`
`4:31-32. In so doing, to maximize the usable “real estate” in the catheter assembly,
`
`a POSITA would taper the pushrod for attachment onto the Kontos-Ressemann
`
`combination. Ex-1807 ¶¶143-49. These modifications allow the diameter of tube
`
`16 to be increased (Ex-1409, 4:46-48), and Kontos would achieve the not-more-
`
`than-one-French differential. Ex-1806 ¶¶129-32.
`
`Id., Fig. 1 (modified by Petitioner).
`
`18
`
`

`

`D. The Kontos-Ressemann-Kataishi combination teaches a double-
`inclined side opening.
`A POSITA was motivated to combine the shape of Kataishi’s distal opening
`
`with Ressemann’s proximal opening. Pet., 58-61. Specifically, adding Kataishi’s
`
`shape to Ressemann’s proximal opening would improve loading of interventional
`
`devices and improve crossability of the catheter. Id. PO is incorrect to argue
`
`otherwise.
`
`PO argues that a POSITA would not recognize that the benefit of Kataishi’s
`
`distal opening—“superior loading of thrombus”—applies equally to Ressemann’s
`
`proximal opening for loading interventional cardiology devices. POR, 46. PO is
`
`incorrect, as the art itself and the knowledge of a POSITA in view of that art
`
`shows the benefits of Kataishi’s inclined shape applies to loading both devices
`
`and thrombi through the lumen. PO ignores, for instance, that Ressemann itself
`
`explicitly teaches that both “[t]he proximal and distal ends 140a, 140b of the
`
`evacuation lumen 140 are preferably angled,” and that this shape on either end
`
`“allows for larger deformable particulate matter to pass through the lumen more
`
`smoothly.” Ex-1408, 6:52-60.
`
`19
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`

`

`
`
`Id., Fig. 1A. The Keith patent—from PO’s own expert—also teaches that the
`
`“proximal and distal ends … are preferably angled … to facilitate smoother
`
`passage of other therapeutic devices.” Ex-1123, 7:54-60 (emphasis added);
`
`Ex-1800, 149:3-18; Ex-1408, Figs. 6E, 6G, 13:57-14:26. Thus, Kataishi’s teaching
`
`that the shape of its distal tip improves that catheter’s ability to suction thrombus
`
`would be understood by a POSITA to also apply to the proximal opening of a
`
`catheter such as Ressemann. Ex-1807 ¶¶150-53; Ex-1806 ¶¶ 140-43. The shape of
`
`Kataishi’s opening provides similar benefits to Ressemann’s opening, and when
`
`implemented in the Kontos-Ressemann combination, provides roughly the same
`
`opening area. Ex-1807 ¶¶158-160.
`
`20
`
`

`

`
`Id., ¶159 (illustrating the larger area of Kataishi’s shape versus Ressemann’s
`
`support collar under wire 14). And an increase in the area of opening makes it
`
`easier to introduce a stent or balloon catheter. Ex-1807 ¶¶150-53; Ex-1806 ¶¶140-
`
`
`
`43.
`
`PO also incorrectly alleges that Kataishi’s “crossability” benefits would not
`
`apply to Ressemann because it does not “see” the vasculature. POR, 46-47. As a
`
`threshold matter, Ressemann (and Keith) teach that both the proximal and distal
`
`ends of evacuation lumen 140 assist in ensuring better crossabilility through the
`
`guide catheter—e.g., “smoother passage of the evacuation sheath assembly 100
`
`through a guide catheter.” Ex-1408, 6:52-57 (emphasis added); Ex-1123, 7:54-60.
`
`A POSITA would recognize Kataishi’s distal shape would also assist devices as
`
`they move through the guide catheter. Indeed, as cited in the Petition, Sakurada
`
`21
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`

`

`performed a “passing ability test” of Kataishi that measured “[t]he length between
`
`the ostium and the distal tip of the aspiration catheter.” Ex-1455, 300-02. Sakurada
`
`found that Kataishi’s shape had improved crossability as the catheter advanced
`
`along various loops in the vasculature. Id. A POSITA would understand these
`
`benefits apply when navigating around loops in a guide catheter. Ex-1807 ¶152.
`
`After all, the guide extension catheter that goes into the guide catheter must also
`
`come out of the guide catheter, and the proximal opening will “see” the inside of
`
`the guide catheter moving out. Because Kataishi’s shape is being used in a
`
`predictive way to achieve a known and similar benefit, a POSITA appreciates that
`
`modifying Ressemann’s proximal opening to include the shape of Kataishi’s distal
`
`tip was an obvious modification determined through routine experimentation and
`
`optimization. Ex-1807 ¶¶154-60; Ex-1405 ¶¶236-43.
`
`PO further argues that Kataishi’s benefits—that allegedly flow from both its
`
`shape and flexibility of the material—is inapplicable to Ressemann’s collar. PO is
`
`again belied by its own expert witness, who testified that once a shape is provided,
`
`a POSITA would readily use routine engineering to create side openings of several
`
`different materials, some more rigid and some more flexible. Ex-1764, 27:9-17,
`
`30:2-8, 31:16-21.
`
`22
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`

`

`IV. ROOT IS PRIOR ART AND RENDERS THE CLAIMS OBVIOUS
`The challenged claims cannot claim priority to the May 3, 2006 ’629
`
`application because it does not provide written description support for (1) a side
`
`opening outside of the substantially rigid segment, or (2) “at least two” inclines.
`
`The Board may consider written description arguments when evaluating whether a
`
`reference qualifies as prior art. Dr. Reddy’s Labs. S.A. v. Indivior UK Ltd.,
`
`IPR2019-00329, 2019 WL 2361782, at *12 (PTAB June 3, 2019); Butamax
`
`Advanced Biofuels LLC v. Gevo, Inc., IPR2013-00539, 2015 WL 1263027, at *8-
`
`15 (PTAB Mar. 3, 2015).
`
`The challenged claims require a side opening outside of the substantially
`
`rigid segment. Ex-1401, claims 25, 52; Ex-1442 ¶¶35-40. Contrary to Teleflex’s
`
`contentions, the claims do not cover Figure 4, or any figure or embodiment
`
`described in the specification for that matter. The claims require a “segment
`
`defining a side opening” separate from a “substantially rigid segment,” taught
`
`nowhere in the specification. The specification describes only one rigid portion
`
`that may include a side opening. Id. The ’629 application only ever describes a side
`
`23
`
`

`

`opening as part of the single, rigid portion 20. Ex-1500, 9-10, 16-20, 38-43, Figs.
`
`4, 12-16; Ex-1442 ¶¶41-63.3
`
`Teleflex suggests that one “integrally formed part” may have discrete
`
`segments. POR, 53. But Teleflex’s interpretation eviscerates the plain meaning of
`
`“segment” and neglects the blatant tension between its reissue claims and the
`
`specification. The claims recite a rigid segment and, separately, a segment defining
`
`a side opening. The claims are different than the specification’s disclosure, in
`
`which the rigid segment includes the side opening. Thus, the challenged claims do
`
`not have written description support and cannot claim priority to May 3, 2006.
`
`Medtronic does not contend that the claims must recite a side opening—rather, if
`
`the claims recite a side opening, the specification requires that it be part of the rigid
`
`segment. This is not the case for the challenged claims.
`
`Thus, Root is prior art because the ’116 patent’s effective filing date is
`
`November 1, 2013—well after Root’s publication date on November 8, 2007. And
`
`PO does not dispute that Root renders the challenged claims obvious in grounds IV
`
`and V.
`
`
`3 Teleflex’s attempt to take Dr. Hillstead’s testimony out of context cannot change
`
`the patent’s disclosure. Regardless, Dr. Hillstead testified that the specification
`
`describes side opening only as part of rigid portion 20. Ex-2244, 186:1-187:19.
`
`24
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`

`

`V.
`
`SECONDARY CONSIDERATIONS DO NOT OVERCOME
`OBVIOUSNESS.
`Teleflex bases its secondary considerations arguments on features known in
`
`the prior art. Teleflex argues that the combination of rapid exchange (“RX”), guide
`
`extension, improved backup support, and a side opening drives GuideLiner’s
`
`success. POR, 78-79. This combination is entirely taught by Itou and Ressemann,
`
`and Kontos includes every element except for a side opening. The earliest RX
`
`GEC in the record is Kontos, followed by Ressemann, and Itou. These devices are
`
`RX, configured to deliver a wide variety of IVCDs, and provide increased backup
`
`support when extended partially past the end of a GEC. Ressemann and Itou also
`
`have a side opening.
`
`A. Teleflex is not entitled to a presumption of nexus.
`Teleflex recites secondary considerations for claim 25 only, which recites a
`
`side opening adapted to receive IVCDs and a one French differential between the
`
`inner diameter of the tubular structure and lumen of the guide catheter. A
`
`rebuttable presumption of nexus exists “when the patentee shows that the asserted
`
`objective evidence is tied to a specific product and that product is the invention
`
`disclosed and claimed in the patent.” WBIP, LLC v. Kohler Co., 829 F.3d 1317,
`
`1329 (Fed. Cir. 2016). Conversely, “when the thing that is commercially successful
`
`is not coextensive with the patented invention…the patentee is not entitled to a
`
`25
`
`

`

`presumption of nexus.” Fox Factory, Inc. v. SRAM, LLC, 944 F.3d 1366, 1373
`
`(Fed. Cir. 2019).
`
`Despite Keith’s declaration, GuideLiner does not practice claim 25 of the
`
`’116 patent. See Ex-2138, App’x B.
`
` Ex-1851, 154:15-155:8
`
`. Further, Teleflex’s own expert previously
`
`
`
`
`
`
`
`testified that “[m]athmatically, those of ordinary skill in the art define one French
`
`as .0131 inches.” Ex-1825 ¶¶43-48 (testifying that