`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`
`Petitioner,
`
`v.
`
`TELEFLEX LIFE SCIENCES LIMITED,
`
`Patent Owner.
`_____________________________
`
`Case No.: IPR2020-1342
`U.S. Patent No. 8,142,413
`______________________________
`
`PETITIONER’S REPLY
`
`
`
`
`

`

`TABLE OF CONTENTS
`
`B.
`
`C.
`
`Page
`
`TABLE OF CONTENTS .......................................................................................... ii
`TABLE OF AUTHORITIES ................................................................................... iii
`I.
`Introduction ...................................................................................................... 1
`II.
`Claim Construction .......................................................................................... 1
`A.
`“Interventional Cardiology Device(s)” ................................................. 1
`B.
`Claim-Step Order .................................................................................. 2
`III. Kontos’s Extension Catheter is not a Narrow Tube. ....................................... 5
`IV. The Asserted Claims are Obvious. .................................................................. 7
`A.
`Claims 1 & 11: Kontos’s support catheter 10 has a “circular cross-
`sectional inner diameter sized such that interventional cardiology
`devices are insertable.” .......................................................................... 7
`Claims 2 & 12: Kontos provides backup support to assist in resisting
`axial and shear forces exerted by the IVCD. ......................................... 7
`Claims 4, 9-12, and 14: Kontos-Adams combination teaches the
`recited proximal openings. ..................................................................11
`1.
`Replacing Kontos’s funnel with a side opening maximizes the
`usable area in the catheter assembly. ........................................11
`Petitioner’s other motivations are not based in hindsight. ........15
`2.
`Claims 13: Kontos-Adams-Takahashi combination teaches the not-
`more-than-one-French limitation. .......................................................19
`Secondary considerations do not overcome the strong showing of
`obviousness. ...................................................................................................20
`A.
`There is no nexus where Itou and Ressemann disclose every element
`of claims 4, 9, and 14. .........................................................................20
`Teleflex’s secondary considerations evidence does not establish
`copying. ...............................................................................................22
`1.
`Teleflex’s alleged evidence of copying is actually copying of
`the prior art. ...............................................................................22
`2. Medtronic did not copy GuideLiner. ........................................23
`VI. CONCLUSION ..............................................................................................24
`
`V.
`
`D.
`
`B.
`
`ii
`
`

`

`TABLE OF AUTHORITIES
`
`
`
`
`
`Page(s)
`
`Cases
`Altiris, Inc. v. Symantec Corp.,
`318 F.3d 1363 (Fed. Cir. 2003) ............................................................................ 2
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .............................................................. 20, 22, 23
`Interactive Gift Express, Inc. v. Compuserve, Inc.,
`256 F.3d 1323 (Fed. Cir. 2001) ............................................................................ 2
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) .................................................................... 23, 24
`Mantech Environmental Corp. v. Hudson Environmental Servs., Inc.,
`152 F.3d 1368 (Fed. Cir. 1998) ...................................................................passim
`Mformation Tech. v. Research in Motion Ltd.,
`764 F.3d 1392 (Fed. Cir. 2014) ............................................................................ 3
`Ormco Corp. v. Align Tech.,
`463 F.3d 1299 (Fed. Cir. 2006) .......................................................................... 20
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 22
`
`
`
`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 side opening, Kontos
`
`teaches each structural limitation of the method claims. But as explained herein,
`
`the use of a side opening 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.
`
`II. CLAIM CONSTRUCTION
`“Interventional Cardiology Device(s)”
`A.
`At institution, “interventional cardiology devices” was construed to refer to
`
`“at least two types of the devices selected from the group that includes, but is not
`
`limited to, guidewires, balloon catheters, stents, and stent catheters.” Institution
`
`Decision (I.D.), Paper 9, 16. Patent Owner’s Response does not dispute this
`
`construction. Thus, the Board should adopt its previous construction.
`
`1
`
`

`

`B. Claim-Step Order
`The parties dispute whether steps in claim 1 must be performed in the
`
`sequence recited. As to limitation 1.f.i, the issue is whether the coaxial guide
`
`catheter must already have been inserted into the standard guide catheter (“GC”)
`
`before an interventional cardiology device (“IVCD”) is inserted thereto. The
`
`answer is no. Claim 1 allows for either preassembly of a coaxial guide and IVCD,
`
`or sequential insertion of the two.
`
`“Unless the steps of a method actually recite an order, the steps are not
`
`ordinarily construed to require one.” Interactive Gift Express, Inc. v. Compuserve,
`
`Inc., 256 F.3d 1323, 1342 (Fed. Cir. 2001). PO argues that claim 1 “only makes
`
`sense if the steps take place in order,” POR, 10, but that is only the case for a
`
`subset of steps. The parties agree that a GC must be inserted into a first artery (1.a)
`
`before its distal end can be positioned in a branch artery (1.b). Similarly, a GC
`
`must already be positioned before the coaxial guide extension catheter can be
`
`inserted thereto (1.c-1.e). As discussed in the Petition, however, and below, the
`
`plain language of the claims permits an IVCD to be advanced either
`
`simultaneously with the guide extension catheter or sequentially. Ex-1405, ¶¶200-
`
`205; Ex-1806, ¶¶17-23; Petition (Pet.), Paper 1, 49-52.
`
`The specification’s disclosure of an embodiment in which insertion is
`
`sequential does not limit the claims. Altiris, Inc. v. Symantec Corp., 318 F.3d 1363,
`
`2
`
`

`

`1369-1371 (Fed. Cir. 2003) (finding error where method steps were construed to
`
`require the order used by the sole embodiment). This is not a case in which
`
`sequential insertion is required in order to perform the claimed method. See e.g.
`
`Mformation Tech. v. Research in Motion Ltd., 764 F.3d 1392, 1398-1400 (Fed. Cir.
`
`2014) (agreeing that claims to remotely deploying software require connection
`
`before transmission); Mantech Environmental Corp. v. Hudson Environmental
`
`Servs., Inc., 152 F.3d 1368, 1375-76 (Fed. Cir. 1998) (determining that claims for
`
`remediating groundwater contamination require the provision of wells, before acid
`
`is introduced thereto).
`
`First, PO argues there can be no “backup support” for an IVCD if there is
`
`preassembly. Patent Owner Response (POR), Paper 24, 16. Even assuming the
`
`preamble is limiting, that is nonsensical. Regardless of whether the IVCD is
`
`inserted simultaneously with—or after—the coaxial guide extension catheter, the
`
`result is the same. Before the IVCD is ever advanced into the coronary artery the
`
`guide extension catheter is already in position within the GC. And the patent
`
`teaches that it is the relative orientation of the GC/guide extension catheter—at the
`
`time the IVCD is being advanced into the coronary artery— that provides backup
`
`support. Ex-1401, Fig. 9, 8:4-9.
`
`Second, step 1.f.i requires that two things be positioned “alongside” each
`
`other: (a) the IVCD; and (b) the extension catheter’s substantially rigid portion.
`
`3
`
`

`

`“Alongside” is an adjective that accurately reflects the relative positions of (a) and
`
`(b), even where the two are preassembled. Teleflex’s experts do not disagree. Ex-
`
`1797, 16:6-17:10; 31:9-23; Ex-1846, 49:23-50:25.
`
`Finally, step 1.f.ii requires that the IVCD be advanced “through and beyond”
`
`the lumen of the extension catheter. Testimony from both PO’s experts confirm
`
`that—following preassembly— an IVCD can be inserted into a guide catheter and
`
`then advanced into the coronary artery. Id. Dr. Brecker concurs, Ex-1405, ¶¶200-
`
`05; Ex-1806, ¶¶99-114, and real-world evidence bears this out. Ex-1848, Abstract,
`
`[0204-0207], Figs. 23a-23c (disclosing preassembly and advancement of a
`
`balloon); Ex-1849, Figs. 2C, 4 (disclosing the same).
`
`Accordingly, the default rule that method steps need not be performed in the
`
`order recited applies to claim 1 of the ’413 patent.1
`
`
`1 Claims depending from claim 1 confirm that the ’413 patent does not require
`
`every step to be performed in the order in which it is recited. As written, claims 10
`
`and 11 would require an IVCD to move in a distal to proximal direction
`
`(advancing first through the full circumference portion of a side opening, and then
`
`through its partially cylindrical portion, or advancing through a flexible tip before
`
`advancing through a reinforced portion). Ex-1401, 12:14-25. Neither scenario
`
`makes sense. In use, an IVCD is advanced in the opposite order, in a proximal to
`
`4
`
`

`

`III. KONTOS’S EXTENSION CATHETER IS NOT A NARROW TUBE.
`PO mischaracterizes Kontos and argues that body 12 must be a “narrow
`
`tube” that “make it more akin to a ‘wet noodle’” and “incapable of resisting
`
`backup forces in the manner required by claims 2 and 7.” POR, 25. PO is wrong.
`
`Ex-1806 ¶¶110-11; Ex-1807 ¶109. Kontos never states that it is “important” for
`
`body 12 to be “narrow” or have a “snug fit.” Ex-1806 ¶¶100-04; 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 ¶103-04; Ex-1807 ¶¶109, 117. Kontos prevents
`
`kinking by reducing the distance between the distal-most portion of the catheter
`
`assembly and the occlusion. Ex-1806 ¶103; Ex-1807 ¶¶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
`
`
`distal direction. Pet., 7-8, 11.
`
`5
`
`

`

`needed to advance the interventional cardiology device (“IVCD”) within body 12
`
`due to its lubricious inner coating. Ex-1806 ¶103; Ex-1807 ¶¶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 ¶¶117.
`
`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 ¶104.
`
`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, 80:12-81:20; Ex-1801, 56:1-10,
`
`60:14-21. Kontos is not so limited, and instead provides that “the device of this
`
`6
`
`

`

`present invention may be used with almost any type of catheter, including over-
`
`the-wire catheters.” Ex-1409, 9:47-50; Ex-1806 ¶105. Kontos teaches what it
`
`teaches and is not limited to fixed wire catheters.
`
`IV. THE ASSERTED CLAIMS ARE OBVIOUS.
`A. Claims 1 & 11: Kontos’s support catheter 10 has a “circular
`cross-sectional inner diameter sized such that interventional
`cardiology devices are insertable.”
`PO does not dispute that Kontos’s support catheter 10 is sized to receive at
`
`least two IVCDs. See I.D., 26-27. As discussed above, PO incorrectly alleges that
`
`the claims require a specific order of operations. They do not and are invalid.
`
`B. Claims 2 & 12: Kontos provides backup support to assist in
`resisting axial and shear forces exerted by the IVCD.
`PO does not dispute that Kontos’s support catheter extends beyond the distal
`
`end of the guide catheter and past the ostium to assist delivery of interventional
`
`cardiology devices to lesions and other parts of the vasculature. Ex-1797, 73:10-
`
`74:2; POR, 22. Instead, PO asserts that Petitioner failed to show that Kontos
`
`inherently teaches the recited back-up functionality because Kontos “says nothing
`
`about exerting a force on a proximal portion of body 12.” POR, 22. But the
`
`structural characteristics of Kontos—which PO does not dispute, and which the
`
`Board has already found invalidated similar claims in a separate IPR—provide
`
`back-up support in two ways: (i) shortening the distance that the IVCD must travel
`
`within the vasculature and (ii) by increasing the moment of inertia of the catheter-
`
`7
`
`

`

`in-catheter assembly. Ex-1806 ¶107-11; Ex-1807 ¶¶14-27, 106-12.
`
`Kontos’s support catheter 10 shortens the distance that the PTCA catheter
`
`must travel while in contact with the tortuous and potentially calcified vasculature.
`
`Ex-1806 ¶108; Ex-1807 ¶¶107, 109, 117. This type of catheter-in-catheter
`
`assembly is a form of “deep seating.”2 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. See also Ex-1797, 73:10-74:2 (“So in Kontos, the physician certainly does
`
`apply a force to the proximal portion of the coaxial guide catheter in order to
`
`advance it through the guide catheter and to advance it out into the vasculature out
`
`to an area to be treated; right? A. Yes, during those parts of the procedure.”).
`
`Further, Kontos provides back-up support by making what is essentially a
`
`“double-catheter.” In so doing, the nested assembly increases the (i) flexural
`
`rigidity, (ii) torsional rigidity, and (iii) resistance to buckling forces of the catheter-
`
`
`2 According to PO’s expert, there are two types of deep seating: (i) extending the
`
`GC past the ostium and into the coronary artery or (ii) positioning the GC at the
`
`ostium and extending the child catheter therein to into the coronary artery.
`
`Ex-1813, 74:21-75:17; Ex-2145 ¶¶60-75.
`
`8
`
`

`

`in-catheter assembly. Ex-1807 ¶¶22-27, 106-08. This in turn increases the moment
`
`of inertia, which results in increased back-up support. Ex-1806 ¶162; Ex-1807
`
`¶¶22-27, 106-08.
`
`PO nonetheless argues that insufficient back-up support is provided because
`
`tube 16 is (i) too flexible and without reinforcement and (ii) positioned with a gap
`
`between its outer wall and the inner wall of the GC. POR, 25. PO is wrong to
`
`characterize Kontos as too flexible, and, as admitted by PO’s expert, a small gap—
`
`such as the 1 French relationship recited in certain claims—is not necessary for
`
`back-up support.
`
`PO argues that tube 16 is “more akin to a ‘wet noodle’” that would “rotate,
`
`bend, or ‘crunch up’” before providing back-up support. POR, 24-25. But as
`
`admitted by PO’s expert, Kontos never says to use “the most pliable molded plastic
`
`from among the range of choices,” and, a POSITA “would expect to pick the
`
`appropriate molded plastic material for the application.” Ex-1800, 69:20-70:13;
`
`Ex-1409, 4:1-4. Further, it makes no sense for tube 16 to be as flexible as PO
`
`suggests, otherwise Kontos could not function for its stated purpose to “permit[] a
`
`physician to deliver, with greatly reduced risk of bending or kinking, a PTCA
`
`catheter to a site of coronary vessel restriction.” Id., 2:22-25; Ex-1806 ¶¶110-12.
`
`Indeed, Kontos contemplates an application that foregoes a GC and uses just
`
`support catheter 10 with PTCA catheter 40. Ex-1409, 8:6-18. Kontos also discloses
`
`9
`
`

`

`use of support assembly 10 as a temporary stent. Id., 6:59-7:5. Foregoing the use of
`
`a GC or using as a temporary stent clearly would not be possible if support
`
`assembly 10 was a wet noodle. Ex-1806 ¶¶110-12.
`
`Kontos’s tube is made of a “molded plastic material, such as polyethylene.”
`
`Ex-1409, 4:1-4. Polyethylene is manufactured in numerous grades and can have
`
`rigid properties (even without metallic reinforcement). Ex-1807 ¶109; see also
`
`Ex-1851, 66:14-16. Finally, PO suggests that the length of tube 16 (~12 inches)
`
`precludes back-up support. POR, 25. PO is wrong, Ex-1807 ¶¶153, 157, and
`
`certain versions of PO’s product had a similar sized 40 cm (<16 inch) tubular
`
`portion. Ex-2138 ¶84.
`
`It was also known that back-up support could be provided without a 1
`
`French relationship between the GC and extension catheter. Ex-1806 ¶¶112-13;
`
`Ex-1807 ¶¶16, 18-19; see also Ex-1814, 5. Kontos’s tube 16 has an outer diameter
`
`of 0.055 inches (Ex-1409, 4:48-50), and, according to PO, could fit in a 6 French
`
`GC, which has an inner diameter of 0.070 inches. Ex-1806 ¶¶112-13. This
`
`difference, referred to as the annular gap, is 0.015 inches. Id. And a 0.015 inch
`
`annual gap, as taught by the Teleflex patent and as admitted by PO’s experts,
`
`provides back-up support. Id.; Ex-2138 ¶61 (showing four-in-six provides back-up
`
`support); Ex-1801, 38:19-20; Ex-1817, 71:23-72:14. Thus, Kontos provides back-
`
`up support even though it does not teach a 1 French relationship. Ex-1806 ¶¶112-
`
`10
`
`

`

`14.
`
`Finally, PO’s argument fails because it misinterprets the back-up claims.
`
`Importantly, PO’s expert admitted that he based his opinion on Kontos failing to
`
`provide “clinically relevant” back-up support. Ex-1801, 63:19-64:19. The back-up
`
`claims, though, only require that the device assists in resisting axial and shear
`
`forces; the device does not have to wholesale prevent axial and shear forces from
`
`exerting backward force. Ex-1806 ¶114. Thus, any contribution by Kontos to resist
`
`such forces will satisfy the back-up claims.
`
`C. Claims 4, 9-12, and 14: Kontos-Adams combination teaches the
`recited proximal openings.
`A POSITA was motivated, with a reasonable expectation of success, to
`
`replace Kontos’s proximal funnel with a side opening. Ex-1405 ¶¶90-101. PO’s
`
`argument assumes a POSITA would make no further modifications to Kontos’s
`
`support assembly 10 after replacing the proximal funnel with a side opening. 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
`
`11
`
`

`

`“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-
`
`1813, 91:18-92:5; 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, 296:17-297:1.
`
`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 ¶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
`
`
`
`12
`
`

`

`inside a 6 French GC and that a 5 French GC offered no advantage. POR, 37.
`
`Kontos has a 0.065 inch outer diameter at base portion 18 (Fig. 3), meaning that to
`
`fit inside a 6 French GC having a 0.070 inch inner diameter, the funnel would only
`
`have a 0.005 inch profile. Ex-1807 ¶¶120-21. This would provide no—or
`
`significantly limit the—funneling function. Ex-1807 ¶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 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.3 Id. ¶125.
`
`b. Maximizing usable real estate: increasing diameter of
`extension catheter.
`The corollary is also true: a POSITA would be motivated to replace the
`
`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.
`
`
`3 For compatibility with a 5 French GC, tube 16 would be molded onto a tapered
`
`wire 14. § IV.E, infra.
`
`13
`
`

`

`
`
`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
`
`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
`
`“snug” fit. POR, 28. But as discussed above, Kontos does not mandate such a tight
`
`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, 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
`
`14
`
`

`

`those skilled in the art.” Ex-1409, 4:21-24. Embedded marker bands were routine
`
`in the art. Ex-1806 ¶119; Ex-1762, 56:3-23. 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 the
`
`marker bands. Ex-1807 ¶¶128-36. PO cannot defeat Petitioners showing that a
`
`POSITA would, based on the teachings of Adams,4 replace Kontos’s funnel with a
`
`side opening.
`
`Petitioner’s other motivations are not based in hindsight.
`2.
`As set forth in the Petition and as taught by Ressemann, side openings
`
`“facilitate smooth[] passage of other therapeutic devices” into the lumen of the
`
`child catheter. Ex-1408, 6:52-57. PO tries to explain away this teaching by noting
`
`Ressemann’s alternative embodiments use a flare or reverse bevel. POR, 28-29.
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`PO’s expert, though, acknowledged that Ressemann’s primary embodiment does
`
`
`4 Contrary to PO’s argument, POR, 31-34, Adams teaches that the proximal
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`opening of the guide seal (extension catheter) receives IVCDs. Ex-1435, [0048]
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`(“The guide seal is open at its distal end to provide for the passage of another
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`catheter or a distal protection element.”), [0061] (“optionally remov[ing]” guide
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`seal). Regardless of when the guide seal is removed, Adams teaches that the distal
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`protection device 15—which is an IVCD (Ex-1801, 85:14-87:2, 121:21-122:3;
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`Ex-1806 ¶8 n.2)—passes through the proximal opening. Ex-1435, [0064], Fig. 2E.
`
`15
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`

`

`not use a flare or reverse bevel. Ex-1801, 107:1-108:4.
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`Moreover, PO’s argument is contradicted by a patent (“Keith”) issued to its
`
`own expert, which contains Ressemann’s verbatim disclosure about side openings
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`“facilitate[ing] smoother passage” of IVCDs. Ex-1123, 7:54-60; Ex-1800,
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`149:3-10. Unlike Ressemann, the Keith patent contains no disclosure of a flare or
`
`funnel in any embodiment (whether primary or alternative). Ex-1800, 149:15-18.
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`Side openings also allow for smoother passage of the catheter assembly as it
`
`navigates the vasculature. Pet., 58. PO argues, though, that this teaching is
`
`“unsupported by the evidence.” POR, 39. PO is wrong. Not only does Ressemann
`
`explicitly state that a side opening “allow[s] for smoother passage of the
`
`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.
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`Finally, a side opening permits smooth re-entry when the extension catheter
`
`is extended beyond the distal end of the GC. Pet., 58-59. PO’s expert previously
`
`found himself in that situation (i.e., passed an extension catheter entirely outside of
`
`16
`
`

`

`the GC),5 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,
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`79:14-21; Ex-1800, 151:17-152:1.
`
`Despite the clear teachings for why a POSITA would replace Kontos’s
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`funnel with a side opening, PO argues that doing so would actually cause
`
`problems. POR, 26-31. First, PO’s argument fails because it is based on a false
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`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.C.1, supra.
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`Even assuming a POSITA made no further modifications after replacing the funnel
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`with a side opening, Kontos would not create a “problem gap” as alleged by PO.
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`POR, 26-30. If Kontos was used with a 6 French GC, the gap between the support
`
`assembly 10 and the inner diameter 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
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`the inner wall of the GC. Ex-1806 ¶¶120-25.
`
`
`5 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.”
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`PO ignores Figure 7, which teaches the intentional advancement into the
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`vasculature. Ex-1409, 6:19-28.
`
`17
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`

`

`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. Ex-1806 ¶125. This is almost double Kontos’s alleged
`
`“problematic” gap. Id.
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`Ex-1123, Fig. 1A (annotations added). For these additional reasons, a POSITA
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`would replace Kontos’s funnel with a side opening. Ex-1806 ¶125.
`
`18
`
`
`
`
`
`

`

`D. Claims 13: Kontos-Adams-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, 43. 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 ¶¶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, 42-43. 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.C.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 ¶¶131-34. These modifications permit the diameter of tube
`
`16 to be increased (Ex-1409, 4:46-50), and Kontos would achieve the not-more-
`
`than-one-French differential. Ex-1806 ¶¶130-32.
`
`19
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`

`

`
`
`Ex-1409, Fig. 1 (modified by Petitioner).
`
`V.
`
`SECONDARY CONSIDERATIONS DO NOT OVERCOME THE
`STRONG SHOWING OF 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, 65-66. This combination is entirely taught by both Itou and
`
`Ressemann.
`
`A. There is no nexus where Itou and Ressemann disclose every
`element of claims 4, 9, and 14.
`Medtronic may rebut Teleflex’s presumption of nexus by demonstrating that
`
`the secondary indicia result from features known in the prior art. In re Kao, 639
`
`F.3d 1057, 1068 (Fed. Cir. 2011). “[I]f the feature that creates the [secondary
`
`consideration] was known in the prior art, the success is not pertinent.” Ormco
`
`Corp. v. Align Tech., 463 F.3d 1299, 1312 (Fed. Cir. 2006).
`
`It is undisputed that RX GECs offering improved backup support and a side
`
`opening existed in the prior art before Root’s conception of the idea claimed in
`
`20
`
`

`

`Teleflex’s patents. Compare Ex-1755 ¶¶27-38 (IPR2020-01341) with Ex-2118 ¶5.
`
`Both Itou and Ressemann disclose the features recited in claims 4, 9, and 14. Pet.,
`
`52-55, 59-60, 67-70, 83, 88-90, 93-95 (IPR2020-01341). Itou and Ressemann are
`
`RX GECs with a side opening that increase backup support when an IVCD is
`
`extended beyond the distal end of the catheter assembly. Ex-1806 ¶¶144-58.
`
`Teleflex does not dispute that Itou recites the necessary structure, despite
`
`being a suction catheter. POR, 41-42 (IPR2020-01341). Itou discloses a
`
`substantially rigid portion that comprises a partially cylindrical portion defining a
`
`side opening. Ex-1407, Figs. 3-4; see, e.g., Ex-1005 ¶227 (IPR2020-01341). Itou
`
`teaches that a protective catheter may be inserted into the lumen through the side
`
`opening and projected from its distal end, and delivered to the target location. Ex-
`
`1407, 4:48-52, 7:1-27, Fig. 5; see, e.g., Ex-1005 ¶¶195, 231-32 (IPR2020-01341).
`
`I