`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`
`Patent Owner.
`_____________________________
`
`Case No.: IPR2020-00136
`U.S. Patent No. RE 45,776
`______________________________
`
`PETITIONERS’ REPLY
`
`
`
`
`PROTECTIVE ORDER MATERIAL
`
`

`

`TABLE OF CONTENTS
`
`Page
`
`
`TABLE OF CONTENTS .......................................................................................... ii
`TABLE OF AUTHORITIES ................................................................................... iv
`I.
`Introduction ...................................................................................................... 1
`II.
`Claim Construction: Claim 36 Does Not Require Two Inclines. .................... 1
`III. Kontos’s Extension Catheter Is Not a Narrow Tube. ...................................... 2
`IV. The Asserted claims are Obvious. ................................................................... 4
`A.
`The Kontos-Ressemann combination teaches the single-incline and
`double-incline side openings of the ʼ776 patent. .................................. 4
`1.
`Replacing Kontos’s funnel with a side opening maximizes the
`usable area in the catheter assembly. .......................................... 5
`Petitioner’s other motivations are not based in hindsight. .......... 9
`Replacing Kontos’s funnel with a side opening would not create
`a problematic gap. .....................................................................11
`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. ......................13
`Even if a POSITA placed Ressemann’s collar underneath the
`pushrod, the Kontos-Ressemann combination still teaches the
`single-incline and double-incline openings. .............................15
`Claim 49: Kontos-Ressemann provides backup support to assist in
`resisting axial and shear forces............................................................18
`Claims 30-31, 53-56: Kontos-Ressemann-Takahashi combination
`teaches the not-more-than-one-French limitation. ..............................20
`The Kontos-Ressemann-Kataishi combination teaches a double-
`inclined side opening. ..........................................................................21
`Teleflex Asserts Secondary Considerations Based Upon Something it Did
`Not Invent—a Rapid Exchange Guide Extension Catheter. .........................25
`A.
`The combination of mother-in-child and Rx was well known. ..........26
`B.
`Side openings existed on prior art devices. .........................................27
`C.
`PO’s copying arguments fail. ..............................................................28
`
`V.
`
`ii
`
`2.
`3.
`
`4.
`
`5.
`
`B.
`
`C.
`
`D.
`
`

`

`VI. CONCLUSION ..............................................................................................32
`VI.
`CONCLUSION .............................................................................................. 32
`
`
`
`
`
`
`iii
`iii
`
`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
`239 F.3d 1343 (Fed. Cir. 2001) .......................................................................... 29
`
`In re Fulton,
`391 F.3d 1195 (Fed. Cir. 2004) ............................................................................ 9
`
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .......................................................................... 25
`
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) .......................................................................... 20
`
`Johns Hopkins Univ. v. Datascope Corp.,
`543 F.3d 1342 (Fed. Cir. 2008) .......................................................................... 31
`
`Mytee Prods., Inc. v. Harris Research, Inc.,
`439 F. App’x 882 (Fed Cir. 2011) ...................................................................... 18
`
`Sakraida v. Ag Pro, Inc.,
`425 U.S. 273 (1976) ............................................................................................ 25
`
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 26
`
`
`
`iv
`
`

`

`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). 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. The
`
`Challenged Claims are invalid as obvious.
`
`II. CLAIM CONSTRUCTION: CLAIM 36 DOES NOT REQUIRE TWO
`INCLINES.
`
`Claim 36 recites that “the segment defining the angled proximal end of the
`
`partially cylindrical opening includes at least one inclined region that tapers into a
`
`non-inclined region.” Ex-1401, 14:22-25. PO did not propose a construction for
`
`this claim,1 and just assumes that claim 36 requires a two-incline side opening.
`
`Paper 40 (“POR”), 42.
`
`Claim 36 only requires a “segment” defining a partially cylindrical opening
`
`with an angled proximal end that tapers into a non-inclined region. As
`
`
`1 In co-pending IPR2020-00135, PO proposes a construction of claim 36. Even if
`
`PO had proposed the same construction here, it would not be correct.
`
`1
`
`

`

`demonstrated by rigid portion 20 throughout the specification, this segment could
`
`extend proximally and distally to the actual opening it defines. The claim also does
`
`not dictate that the non-inclined region is part of the segment, stating only that the
`
`angled proximal end tapers into a non-inclined region.
`
`Finally, PO’s attempt to read Figure 4 into the claim is nonsensical. In
`
`Figure 4 the distal incline tapers into the non-inclined region within the opening.
`
`Ex-1401, Fig. 4. The proximal angle claimed here tapers into the pushrod. Id.,
`
`7:10.
`
`
`
`IPR2020-00135, Paper 44, 10-11. If Figure 4 is the basis for this claim, the non-
`
`inclined region is the pushrod, which is not part of the opening.
`
`III. KONTOS’S EXTENSION CATHETER IS NOT A NARROW TUBE.
`
`PO argues that Kontos’s body 12 must be a “narrow tube” that requires “a
`
`snug fit around [the] small-diameter PTCA catheter.” POR, 10. PO is wrong. Ex-
`
`1806, ¶¶142-50; Ex-1807, ¶¶159-63. Kontos never states that it is “important” for
`
`2
`
`

`

`body 12 to be “narrow” or have a “snug fit.” Ex-1806, ¶¶144-45; 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, ¶147; Ex-1807, ¶¶14-27, 160-163. Kontos
`
`prevents kinking by reducing the distance between the distal-most portion of the
`
`catheter assembly and the occlusion. Ex-1806, ¶147; Ex-1807, ¶¶20-21, 163.
`
`“[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, ¶147; Ex-1807, ¶¶20-21, 163; 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, ¶147; Ex-1807, ¶¶20-21, 163.
`
`3
`
`

`

`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, ¶148.
`
`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, ¶146. 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, ¶¶149-50.
`
`IV. THE ASSERTED CLAIMS ARE OBVIOUS.
`
`A. The Kontos-Ressemann combination teaches the single-incline
`and double-incline side openings of the ʼ776 patent.
`
`A POSITA was motivated, with a reasonable expectation of success, to
`
`replace Kontos’s proximal funnel with Ressemann’s support collar 2141
`
`4
`
`

`

`(“Ressemann’s collar”). Pet., 25-34. At Institution, the Board agreed, explaining
`
`that “Petitioner ha[d] demonstrated a reasonable likelihood of prevailing” on this
`
`combination. Paper 20 (“I.D.”), 21. Replacing Kontos’s proximal funnel with
`
`Ressemann’s support collar 2141 results in a proximal opening with two inclines.
`
`Pet., 55-56.
`
`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, ¶169. 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, ¶81; 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, ¶161 (IPR2020-00129). And PO’s expert agreed that
`
`the use of a proximal funnel does not maximize the useable “real estate” within the
`
`5
`
`

`

`catheter assembly. Ex-1813, 92:19-24. Further, inventor Root similarly testified
`
`that he “
`
`
`
`” of the device. Ex-1115, 296:23-297:1.
`
`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, ¶163. 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, 25-26.
`
`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, ¶¶164-166. This
`
`would provide no—or significantly limit the—funneling function. Id., ¶167.
`
`Further, even at 0.005 inches, the funnel would “rub” in a 6 French GC, which, as
`
`6
`
`

`

`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, ¶170. Further, a POSITA
`
`would still be 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.2 Id.,
`
`¶171.
`
`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-1806,
`
`¶172.
`
`
`2 For compatibility with a 5 French GC, tube 16 would be molded onto tapered
`
`wire 14. § IV.C, infra.
`
`
`
`7
`
`

`

`Ex-1405, ¶165. 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
`
`that can be delivered.” Ex-2145, ¶129. 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
`
`“snug” fit. POR, 23. But for the reasons discussed above, Kontos does not mandate
`
`such a fit. § III, 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, 23-24. 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, ¶173; 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, ¶¶168-82. PO cannot defeat Petitioners showing
`
`that a POSITA would replace Kontos’s funnel with Ressemann’s collar.
`
`8
`
`

`

`2.
`
`Petitioner’s other motivations are not based in hindsight.
`
`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, ¶187. PO’s expert agreed:
`
`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.
`
`Additionally, replacing Kontos’s funnel with Ressemann’s collar would, as
`
`noted in the Institution Decision, “reinforce the proximal opening … in the
`
`presence of deforming forces.” I.D., 21 (citing Ex-1408, 24:49-53). This would
`
`have been advantageous given that, according to PO, Kontos’s tube is flexible.
`
`IPR2020-00127, Paper 41, 24-25. PO argues, though, that a POSITA would not
`
`use Ressemann’s collar because it was “simple[r]” to “reinforce Kontos’s existing
`
`opening with a stiffening material (such as metal).” POR, 29 n.5. PO’s argument
`
`misses the mark, however, as the Federal Circuit “does not require that a particular
`
`combination must be the preferred, or the most desirable, combination described in
`
`the prior art in order to provide the motivation for the current invention.” In re
`
`Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004).
`
`9
`
`

`

`Further, as noted in the Institution Decision, “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.’” I.D., 21 (citing Ex-1408, 23:17–20). Despite this clear
`
`teaching, PO argues that side openings actually cause device “catching or hang
`
`up.” POR, 19-20. This argument, though, is contradicted by a patent (“Keith”)
`
`issued to PO’s 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.
`
`Side openings also allow for smoother passage of the catheter assembly as it
`
`navigates the vasculature. Pet., 32. PO argues, though, that this teaching is
`
`“unsupported by the evidence.” POR, 26. PO is wrong. Not only does Ressemann
`
`explicitly state that a side opening “allow[s] for smoother passage,” but an
`
`identical teaching is also recited in Keith. Ex-1523, 7:54-60. Further, in prior
`
`litigation, PO’s expert, Mr. Keith, argued that “
`
`
`
` 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., 45-46. PO’s expert previously
`
`10
`
`

`

`found himself in that situation (i.e., passed an extension catheter entirely outside of
`
`the GC),3 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, 17-22. 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
`
`assembly. As explained above, a POSITA would have done so. § IV.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
`
`
`3 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, 27. PO ignores Figure 7, which teaches the intentional advancement into the
`
`vasculature. Ex-1409, 6:19-28, Fig. 7.
`
`11
`
`

`

`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, ¶¶ 174-77.
`
`Ex-1409, Fig. 1 (modified by Petitioner).
`
`Ressemann and Keith buttress this conclusion. Ex-1806, ¶178. 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., ¶179. This is almost double Kontos’s alleged “problematic”
`
`gap. Id.
`
`
`
`
`
`12
`
`

`

`Ex-1123, Fig. 1A (annotations added). For these additional reasons, a POSITA
`
`would replace Kontos’s funnel with Ressemann’s collar. Ex-1806, ¶179.
`
`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.
`
`Id., 42. 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, ¶¶188-190, 90-92. In so
`
`doing, as shown in the below schematic, the proposed modification would
`
`
`
`13
`
`

`

`eliminate any concern about creating a problematic catch-point.
`
`
`
`Ex-1807, ¶¶188-190.
`
`PO is also incorrect to argue that while traversing the vasculature, forces
`
`would have “tend[ed] to push the tab off of the wire.” POR, 41. Indeed, numerous
`
`examples, including those cited on the face of the Teleflex patent (see, e.g., Ex-
`
`1463) disclose catheter assemblies with portions having convex up (distal lumen)
`
`and convex down components (pushrod). Ex-1807, ¶¶191, 93-96. Further,
`
`Ressemann’s collar could have been attached to Kontos’s wire 14, as taught by
`
`Ressemann, with a thin layer of solvent casting. Ex-1807, ¶¶90, 91, 101, 131, 190;
`
`Ex-1408, 24:2-11. Doing so would have maintained the proximal incline of
`
`Ressemann’s collar. Ex-1807, ¶190. 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 ʼ776 patent. Ex-
`
`14
`
`

`

`1806, ¶194
`
`
`
`Ex-1009, 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, ¶196. Therefore, even
`
`if Ressemann’s collar was placed underneath Kontos’s pushrod—as alleged by PO
`
`(POR, 39)—the Kontos-Ressemann combination still teaches a two-inclined
`
`opening. Ex-1806, ¶195.
`
`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.
`
`15
`
`

`

`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.
`
`
`
`16
`
`

`

`Ex-1116 (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, ¶¶197-98.
`
`
`
`17
`
`

`

`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, ¶¶199-200 (identifying B and C).
`
`
`
`Ex-1807, ¶192.
`
`B. Claim 49: Kontos-Ressemann provides backup support to assist in
`resisting axial and shear forces.
`
`The Kontos-Ressemann combination provides back-up support in two ways:
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`(i) shortening the distance that the IVCD must travel within the vasculature and (ii)
`
`increasing the moment of inertia of the catheter-in-catheter assembly. Ex-1806,
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`¶¶159-67; Ex-1807, ¶¶14-27, 152-158, 193.4
`
`
`4 PO argues that “Petitioner bears the burden of showing that Kontos …
`
`inherently” satisfies claim 49. POR, 43. Petitioner need only show that Kontos-
`
`Ressemann teaches the structure of claim 49. Indeed, “after establishing a prima
`
`facie case of anticipation,” the burden of production shifts to the PO “to show that
`
`the prior art structure did not inherently possess the functionally defined limitations
`
`of the claimed apparatus.” Mytee Prods., Inc. v. Harris Research, Inc., 439 F.
`
`18
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`Kontos’s support catheter 10 shortens the distance that the PTCA catheter
`
`must travel while in contact with the tortuous and potentially calcified vasculature.
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`Ex-1806, ¶161; Ex-1807, ¶¶153, 155, 163. This type of catheter-in-catheter
`
`assembly that reduces the distance to the target location is a form of “deep
`
`seating.”5 Ex-1813, 75:4-17. And as admitted by PO’s expert, deep seating
`
`provides back-up support. Id., 76:4-6. More particularly, a physician must apply
`
`less force to advance an IVCD within the catheter assembly (by comparison to
`
`advancing within the vasculature), and thus, provides back-up support. § III, supra.
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`Further, Kontos-Ressemann provides back-up support by making what is
`
`essentially a “double-catheter.” In so doing, the nested assembly increases the (i)
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`flexural rigidity, (ii) torsional rigidity, and (iii) resistance to buckling forces of the
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`catheter-in-catheter assembly. Ex-1807, ¶¶22-27. This in turn increases the
`
`moment of inertia, which results in increased back-up support. Ex-1806, ¶162; Ex-
`
`
`App’x 882, 886 (Fed Cir. 2011). Regardless, as set forth herein, Kontos-
`
`Ressemann inherently satisfies claim 49.
`
`5 PO’s expert opined that there are two types of deep seating: (i) extending the GC
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`past the ostium and into the coronary artery or (ii) positioning the GC at the ostium
`
`and using a child catheter therein to extend into the coronary artery. Ex-1813,
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`74:21-75:17; Ex-2145, ¶¶51, 78.
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`1807, ¶27.
`
`PO chose to describe its invention by what it does: provide back-up support.
`
`“[C]hoosing to define an element functionally, i.e., by what it does, carries with it a
`
`risk.” In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997). This is because “[i]t
`
`is well settled that the recitation of a new intended use for an old product does not
`
`make a claim to that old product patentable.” Id. at 1477. Indeed, as described in
`
`Schreiber, a functional element will “not have patentable weight if the structure is
`
`already known, regardless of whether it has ever been used in any way [for the
`
`recited function].” Id. Nevertheless, for the reasons set forth herein, even if the
`
`functional claim language is afforded patentable weight, Kontos-Ressemann
`
`teaches this limitation. Ex-1806, ¶¶163-67.
`
`C. Claims 30-31, 53-56: 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, 44. As discussed above, PO is incorrect to
`
`argue that Kontos requires a snug fitting body 12. § III, supra. Thus, a POSITA
`
`was motivated to apply the teachings of Takahashi to increase back-up support.
`
`Ex-1806, ¶¶189, 191.
`
`PO also argues that a POSITA would not have an expectation of success to
`
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`

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`modify Kontos to achieve the 1 French differential. POR, 45-46. 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. § IV.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,
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`a POSITA would taper the pushrod for attachment onto the Kontos-Ressemann
`
`combination. Ex-1807, ¶¶183-195. 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, ¶¶190, 192.
`
`Id., Fig. 1 (modified by Petitioner).
`
`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., 68-72. Specifically, adding Kataishi’s
`
`shape to Ressemann’s proximal opening would improve loading of interventional
`
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`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, 51. 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.
`
`Id., Fig. 1A. The Keith patent 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,
`
`
`
`22
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`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, ¶¶196-
`
`199; Ex-1806, ¶¶ 201-04. 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,
`
`¶¶204-07.
`
`
`
`Id., ¶205 (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, ¶¶196-99; Ex-1806,
`
`¶¶201-04.
`
`23
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`

`
`
`PO also incorrectly alleges that Kataishi’s “crossability” benefits would not
`
`apply to Ressemann because it does not “see” the vasculature. POR, 50-51. As a
`
`threshold matter, Ressemann teaches that both the proximal and distal ends of
`
`evacuation lumen 140 assist in ensuring “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 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, ¶198. 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, ¶¶200-206; Ex-1405, ¶¶243-50.
`
`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 as of the filing date of the
`
`24
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`

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`’776 Patent, 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.
`
`V. TELEFLEX ASSERTS SECONDARY CONSIDERATIONS BASED
`UPON SOMETHING IT DID NOT INVENT—A RAPID EXCHANGE
`GUIDE EXTENSION CATHETER.
`
`The