UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`
`Patent Owner.
`_____________________________
`
`Case No.: IPR2020-00127
`U.S. Patent No. 8,048,032
`______________________________
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`PETITIONERS’ REPLY
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`

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`
`
`TABLE OF CONTENTS
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`Page
`TABLE OF CONTENTS .......................................................................................... ii
`TABLE OF AUTHORITIES ................................................................................... iv
`I.
`Introduction ...................................................................................................... 1
`II.
`The board can adopt its preliminary construction of “Interventional
`Cardiology Device(s).” .................................................................................... 1
`III. Kontos’s Extension Catheter is not a Narrow Tube. ....................................... 2
`IV. The Asserted Claims are Obvious. .................................................................. 4
`A.
`Claims 1 & 11: Kontos’s support catheter 10 has a “cross-sectional
`inner diameter through which interventional cardiology devices are
`insertable.” ............................................................................................. 4
`Claims 2 & 12: Kontos provides backup support to assist in resisting
`axial and shear forces exerted by the IVCD. ......................................... 5
`Claims 3, 4, 9, 13, and 18: Kontos-Adams combination teaches the
`recited proximal openings. ..................................................................10
`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
`After replacing the funnel with a side opening, support catheter
`10 would remain coaxial with the GC. .....................................18
`Claim 6: Kontos-Adams combination teaches a flexible cylindrical
`reinforced portion. ...............................................................................19
`Claims 8 & 17: Kontos-Adams-Takahashi combination teaches the
`not-more-than-one-French limitation. .................................................21
`Claim 20: Kontos-Adams-Berg combination teaches the recited PSIs.
` .............................................................................................................22
`PO Asserts Secondary Considerations Based Upon Something it Did Not
`Invent—a Rapid-Exchange Version of a Guide Extension Catheter. ...........22
`A. Mother-in-Child and Rx devices were well known, and so was the
`combination. ........................................................................................24
`Side openings existed on prior art devices. .........................................24
`
`V.
`
`B.
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`ii
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`B.
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`C.
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`D.
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`E.
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`F.
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`2.
`3.
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`

`

`
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`C.
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`PO’s secondary consideration evidence all relates to prior art features
`and functionality. .................................................................................26
`VI. CONCLUSION ..............................................................................................29
`
`
`
`
`
`iii
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`

`

`
`
`Cases
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
`239 F.3d 1343 (Fed. Cir. 2001) .................................................................... 26, 27
`
`Howmedica Osteonics Corp. v. Zimmer, Inc.,
`640 F. App’x 951 (Fed. Cir. 2016) ....................................................................... 6
`
`In re Bigio,
`381 F.3d 1320 (Fed. Cir. 2004) .......................................................................... 22
`
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .................................................................... 23, 26
`
`Johns Hopkins Univ. v. Datascope Corp.,
`543 F.3d 1342 (Fed. Cir. 2008) .......................................................................... 28
`
`Mytee Prods., Inc. v. Harris Research, Inc.,
`439 F. App’x 882 (Fed Cir. 2011) .................................................................... 5, 6
`
`Ormco Corp. v. Align Tech., Inc.,
`463 F.3d 1299 (Fed. Cir. 2006) .......................................................................... 26
`
`Sakraida v. Ag Pro, Inc.,
`425 U.S. 273 (1976) ............................................................................................ 23
`
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 23
`
`
`
`iv
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`

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`
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`I.
`
`INTRODUCTION
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`Patent Owner (“PO”) does not dispute, because it cannot, that Kontos
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`describes its “support catheter” as a “mini guide catheter.” Ex-1409, 3:40-49. Nor
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`does PO dispute that Kontos teaches, just like the coaxial guide catheter 12 of the
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`Teleflex patent, that support catheter 10 includes a short distal lumen (body 12)
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`coupled to a pushrod (wire 14). Other than the claimed side opening, Kontos
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`teaches each structural limitation of the Challenged Claims. But as explained
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`herein, the use of a side opening was an obvious modification. The Challenged
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`Claims are invalid as obvious.
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`II. THE BOARD CAN ADOPT ITS PRELIMINARY CONSTRUCTION
`OF “INTERVENTIONAL CARDIOLOGY DEVICE(S).”
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`The parties agree that “interventional cardiology device(s)” means “devices
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`including, but not limited to, guidewires, balloon catheters, stents, and stent
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`catheters.” Paper 1 (“Pet.”), 13. Medtronic maintains that “interventional
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`cardiology device(s)” requires that the lumen of the tubular structure is sized to
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`receive only one such device.1 In its Institution Decision, the Board found that
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`“‘interventional cardiology devices’ refers to at least two types of the devices
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`selected from the group that includes, but is not limited to, guidewires, balloon
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`catheters, stents, and stent catheters.” Paper 20 (“I.D.”), 19. But because resolution
`
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`1 Petitioner reiterates its position to preserve for appeal. Pet., 13, 27-29.
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`1
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`

`

`
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`of this question does not impact the outcome of this IPR, the Board can adopt its
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`preliminary construction of “interventional cardiology devices.”
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`In its POR, PO advances only one new argument: the Board’s construction
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`ignores that the specification states that the purported invention facilitates delivery
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`of “standard coronary devices.” Paper 41 (“POR”), 10. This non-sequitur has no
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`bearing, though, on the construction of the claim term “interventional cardiology
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`device(s).” PO does not (because it cannot) support its contention that “standard
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`coronary devices” is the same as “interventional cardiology devices.” Compare
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`IPR2020-00126, Paper 44, 11 (arguing construction of “interventional cardiology
`
`device(s)” requires that the device “provide treatment”), with Ex-1800, 63:20-64:1
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`(stating that some, but not all, standard coronary devices provide treatment). The
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`Board should adopt its construction from the Institution Decision.
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`III. KONTOS’S EXTENSION CATHETER IS NOT A NARROW TUBE.
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`PO acknowledges that Kontos teaches each structural limitation of the
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`independent claims. Ex-1800, 114:20-115:3; POR, 18-21. For the dependent
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`claims, PO mischaracterizes Kontos and argues that body 12 must be a “narrow
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`tube” that requires “a snug fit around the small-diameter PTCA catheter.” POR, 13.
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`PO is wrong. Ex-1806 ¶¶142-50; Ex-1807 ¶¶159-63. Kontos never states that it is
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`“important” for body 12 to be “narrow” or have a “snug fit.” Ex-1806 ¶¶144-45;
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`Ex-1801, 52:5-8 (language is silent concerning “snugness”); Ex-1800, 77:6-11,
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`2
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`

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`
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`78:12-20. In fact, Kontos teaches the opposite, explaining that the size of body 12
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`should be suitable “for existing PTCA catheters” and that “[o]f course, other sizes
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`may be used for other applications.” Ex-1409, 4:46-48, 4:61-5:2.
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`PO’s argument is also contradicted by how Kontos actually prevents kinking
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`of the PTCA catheter. Ex-1806 ¶147; Ex-1807 ¶¶14-27, 160-63. Kontos prevents
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`kinking by reducing the distance between the distal-most portion of the catheter
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`assembly and the occlusion. Ex-1806 ¶147 Ex-1807 ¶¶20-21, 163. “[B]ody 12
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`functions as a guide catheter extension,” by reducing “the gap that PTCA catheter
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`40 must negotiate without assistance …, [which] lessens considerably the tendency
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`of the PTCA catheter 40 to bend, buckle or kink.” Ex-1409, 5:49-56. This is
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`because, by comparison to advancement within the vasculature, significantly less
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`force is needed to advance the interventional cardiology device (“IVCD”) within
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`body 12 due to its lubricious inner coating. Ex-1806 ¶147; Ex-1807 ¶¶20-21, 163;
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`Ex-1813, 52:14-53:8, 72:24-73:14. It is Kontos’s ability to shorten the distance that
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`the IVCD traverses in the vasculature—especially in regions that are not straight or
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`heavily calcified—and not the spatial relationship with the IVCD that reduces the
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`likelihood of kinking. Ex-1806 ¶147; Ex-1807 ¶¶20-21, 163.
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`This conclusion is buttressed by the real-world experience of PO’s expert.
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`Dr. Graham testified that he has never had an IVCD kink within a catheter
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`assembly. Ex-1813, 52:14-53:8. In other words, the closeness of support assembly
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`3
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`

`

`
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`10 and the PTCA catheter 40 is irrelevant, as kinking (if it does occur) would not
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`happen until the IVCD is in the vasculature. Ex-1806 ¶148.
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`Not only is a close-fitting tube unnecessary to prevent kinking of the PTCA
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`catheter, but, as Dr. Brecker explains, it would be detrimental. Ex-1806 ¶146. If the
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`relationship is too “snug,” the IVCD can be damaged when loaded into the
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`extension catheter, especially post-expansion, when the PTCA balloon is retracted
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`proximally into the extension catheter. Id.
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`Finally, even if Kontos taught a small body 12 with a “snug fit” to the
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`IVCD, PO’s argument still fails because it is premised on Kontos’s invention being
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`limited to fixed-wire catheters. Ex-1800, 76:2-8, 80:12-81:20; Ex-1801, 56:1-10,
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`60:14-21. Kontos is not so limited, and instead provides that “the device of this
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`present invention may be used with almost any type of catheter, including over-
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`the-wire catheters.” Ex-1409 9:47-50; Ex-1806 ¶¶149-50.
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`IV. THE ASSERTED CLAIMS ARE OBVIOUS.
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`A. Claims 1 & 11: Kontos’s support catheter 10 has a “cross-
`sectional inner diameter through which interventional cardiology
`devices are insertable.”
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`Kontos’s support catheter 10 is sized to receive at least two IVCDs. See I.D.,
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`26-27. Body 12 receives “a PTCA catheter 40,” Ex-1409, 5:2-5, Figs. 5, 6A-C, and
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`as admitted by PO, Kontos is also sized to receive a guidewire. Ex-2138 ¶48; Ex-
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`1806 ¶¶153-54. Therefore, Kontos satisfies this claim limitation. Ex-1806 ¶¶4-7.
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`4
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`

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`Even under PO’s construction of IVCD, Kontos satisfies this claim
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`limitation. Kontos teaches that the tubular portion has an inner diameter of 0.045
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`inches. Ex-1409, 4:46-50. In the 2005-2006 timeframe, stent and stent catheters
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`were sized to travel through Kontos’s body 12. Ex-1806 ¶¶155-58; Ex-1415, 85;
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`Ex-1802, 6-7, 15, 21, 25; Ex-2116, 335:18-336:1. Importantly, PO’s expert did
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`“not give[] any thought as to whether there [were] other interventional cardiology
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`devices in the ‘90s that could be inserted through … Kontos.” Ex-1800, 122:4-12;
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`see also Ex-1813, 118:14-19. Petitioner’s evidence is unrebutted. Kontos teaches
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`this limitation. Ex-1806 ¶152.
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`B. Claims 2 & 12: Kontos provides backup support to assist in
`resisting axial and shear forces exerted by the IVCD.
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`PO does not dispute that Kontos teaches each structural limitation of claim 2
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`and 12 (“Back-up Claims”). Ex-1800, 125:14-20; POR, 21-25. Instead, PO asserts
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`that Petitioner failed to show that Kontos inherently teaches the recited back-up
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`functionality. POR, 22. PO’s argument, though, is based on an incorrect
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`application of law. It is PO’s burden—not Petitioner’s—to establish that Kontos
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`does not provide back-up support. Even so, Kontos necessarily provides back-up
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`support.
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`PO contends that Schreiber “did not establish a presumption of inherency
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`[based on structural similarity] for issued patents.” Id. (citing Mytee Prods., Inc. v.
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`Harris Research, Inc., 439 F. App’x 882, 886 (Fed Cir. 2011)). PO, though, omits
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`5
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`
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`the very next sentence of Mytee, which explains that Schreiber holds “that after
`
`establishing a prima facie case of anticipation,” the burden of production shifts to
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`the PO “‘to show that the prior art structure did not inherently possess the
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`functionally defined limitations of the claimed apparatus.’” 439 F. App’x at 886.
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`Because Kontos teaches each structural limitation of the Back-up Claims
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`and PO’s experts agree that Kontos provides some measure of back-up support, the
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`burden of production shifts to PO to show that Kontos does not inherently possess
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`the recited functionality. Howmedica Osteonics Corp. v. Zimmer, Inc., 640 F.
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`App’x 951, 957 (Fed. Cir. 2016). PO has not done so and merely argues that
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`“Kontos’ device likely would not resist axial and sheer forces.” POR, 23 (emphasis
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`added). For this reason alone, the Board should find that Kontos satisfies the Back-
`
`up Claims.
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`Regardless, the structural characteristics of Kontos—which PO does not
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`dispute—provide back-up support in two ways: (i) shortening the distance that the
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`IVCD must travel within the vasculature and (ii) by increasing the moment of
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`inertia of the catheter-in-catheter assembly. Ex-1806 ¶159-67; Ex-1807 ¶¶14-27,
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`152-58.
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`Kontos’s support catheter 10 shortens the distance that the PTCA catheter
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`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
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`6
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`

`

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`assembly is a form of “deep seating.”2 Ex-1813, 75:4-17. And as admitted by PO’s
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`expert, deep seating provides back-up support. Id., 76:--6. More particularly, a
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`physician must apply less force to advance an IVCD within the catheter assembly
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`(by comparison to advancing within the vasculature), and thus, provides back-up
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`support. § III, supra.
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`Further, Kontos provides back-up support by making what is essentially a
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`“double-catheter.” In so doing, the nested assembly increases the (i) flexural
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`rigidity, (ii) torsional rigidity, and (iii) resistance to buckling forces of the catheter-
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`in-catheter assembly. Ex-1807 ¶¶22-27, 154-58. This in turn increases the moment
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`of inertia, which results in increased back-up support. Ex-1806 ¶162; Ex-1807
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`¶¶22-27, 154-58.
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`PO nonetheless argues that insufficient back-up support is provided because
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`tube 16 is (i) too flexible and without reinforcement and (ii) positioned with a gap
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`between its outer wall and the inner wall of the GC. POR, 23-25. PO is wrong to
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`characterize Kontos as too flexible, and, as admitted by PO’s expert, a small gap—
`
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`2 According to PO’s expert, there are two types of deep seating: (i) extending the
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`GC past the ostium and into the coronary artery or (ii) positioning the GC at the
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`ostium and extending the child catheter therein to into the coronary artery.
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`Ex-1813, 74:21-75:17; Ex-2145 ¶¶51, 78.
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`7
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`

`

`
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`such as the 1 French relationship recited in certain claims—is not necessary for
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`back-up support.
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`PO argues that tube 16 is “more akin to a ‘wet noodle’” that would “rotate,
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`bend, or ‘crunch up’” before providing back-up support. POR, 24-25. But as
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`admitted by PO’s expert, Kontos never says to use “the most pliable molded plastic
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`from among the range of choices,” and, a POSITA “would expect to pick the
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`appropriate molded plastic material for the application.” Ex-1800, 69:20-70:13;
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`Ex-1409, 4:1-4. Further, it makes no sense for tube 16 to be as flexible as PO
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`suggests, otherwise Kontos could not function for its stated purpose to “permit[] a
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`physician to deliver, with greatly reduced risk of bending or kinking, a PTCA
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`catheter to a site of coronary vessel restriction.” Id., 2:22-25; Ex-1806 ¶¶163-64.
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`Indeed, Kontos contemplates an application that foregoes a GC and uses just
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`support catheter 10 with PTCA catheter 40. Ex-1409, 8:6-18. Kontos also discloses
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`use of support assembly 10 as a temporary stent. Id., 6:59-7:5. Foregoing the use of
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`a GC or using as a temporary stent clearly would not be possible if support
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`assembly 10 was a wet noodle. Ex-1806 ¶¶163-64.3
`
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`3 Kontos’s tube is made of a “molded plastic material, such as polyethylene.”
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`Ex-1409, 4:1-4. Polyethylene is manufactured in numerous grades and can have
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`rigid properties (even without metallic reinforcement). Ex-1807 ¶155; see also
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`8
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`

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`It was also known that back-up support could be provided without a 1
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`French relationship between the GC and extension catheter. Ex-1806 ¶¶165-66;
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`Ex-1807 ¶¶16, 18-19; see also Ex-1814, 1. Kontos’s tube 16 has an outer diameter
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`of 0.055 inches (Ex-1409, 4:48-50), and, according to PO, could fit in a 6 French
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`GC, which has an inner diameter of 0.070 inches. POR, 35. This difference,
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`referred to as the annular gap, is 0.015 inches. Ex-1806 ¶¶165-66. And a 0.015
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`inch annual gap, as taught by the Teleflex patent and as admitted by PO’s experts,
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`provides back-up support. Ex-1806 ¶¶165-66; Ex-2138 ¶61 (showing four-in-six
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`provides back-up support); Ex-1801, 38:19-20; Ex-1817, 71:23-72:14. Thus,
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`Kontos provides back-up support even though it does not teach a 1 French
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`relationship. Ex-1806 ¶¶165-66.
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`Finally, PO’s argument fails because it misinterprets the Back-up Claims.
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`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
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`Claims, though, only require that the device assists in resisting axial and shear
`
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`Ex-2015, 66:14-16. Finally, PO suggests that the length of tube 16 (~12 inches)
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`precludes back-up support. POR, 23. PO is wrong, Ex-1807 ¶¶153, 157, and
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`certain versions of PO’s product had a similar sized 40 cm (<16 inch) tubular
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`portion. Ex-2138 ¶85.
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`9
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`forces; the device does not have to wholesale prevent axial and shear forces from
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`exerting backward force. Ex-1806 ¶167. Thus, any contribution by Kontos to resist
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`such forces will satisfy the Back-up Claims.
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`PO chose to describe its invention by what it does: provide back-up support.
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`“[C]hoosing to define an element functionally, i.e., by what it does, carries with it a
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`risk.” Schreiber, 128 F.3d at 1478. This is because “[i]t is well settled that the
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`recitation of a new intended use for an old product does not make a claim to that
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`old product patentable.” Id., 1477. Indeed, as described in Schreiber, a functional
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`element will “not have patentable weight if the structure is already known,
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`regardless of whether it has ever been used in any way [for the recited function].”
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`Id. Nevertheless, for the reasons set forth herein, even if the functional claim
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`language is afforded patentable weight, Kontos teaches this limitation. Ex-1806
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`¶¶160, 167.
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`C. Claims 3, 4, 9, 13, and 18: Kontos-Adams combination teaches the
`recited proximal openings.
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`A POSITA was motivated, with a reasonable expectation of success, to
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`replace Kontos’s proximal funnel with a side opening. Ex-1405 ¶¶90-101. PO’s
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`argument assumes a POSITA would make no further modifications to Kontos’s
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`support assembly 10 after replacing the proximal funnel with a side opening. Even
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`if a POSITA made no further modifications, though, PO’s argument still fails.
`
`10
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`

`

`
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`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
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`usable real estate within the catheter assembly. Ex-1806 ¶169. This is particularly
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`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
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`“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-
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`1813, 91:18-92:5; Ex-2138 ¶161 (IPR2020-00129). And PO’s expert agreed that
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`the use of a proximal funnel does not maximize the useable “real estate” within the
`
`catheter assembly. Ex-1813, 92:19-24. Further, Mr. Root, the lead inventor,
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`similarly testified that he “
`
`
`
`. Ex-2015, 296:17-297:1.
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`a. Maximizing usable real estate: reducing diameter of
`GC.
`
`Replacing Kontos’s funnel with a side opening reduces the outer diameter of
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`the extension catheter, which permits the use of a smaller-diameter GC.
`
`11
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`

`

`
`
`
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`Ex-1405 ¶193. 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, 35.
`
`Kontos has a 0.065 inch outer diameter at base portion 18 (Fig. 3), meaning that to
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`fit inside a 6 French GC having a 0.070 inch inner diameter, the funnel would only
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`have a 0.005 inch profile. Ex-1807 ¶¶164-66. This would provide no—or
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`significantly limit the—funneling function. Ex-1807 ¶167. Further, even at 0.005
`
`inches, the funnel would “rub” in a 6 French GC, which, as admitted by PO’s
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`expert, “would hinder the ability to facilitate smooth passage.” Ex-1801, 115:14-
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`117:7. Thus, replacing Kontos’s funnel with a side opening would improve the
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`trackability within the GC. Ex-1806 ¶170. Further, a POSITA was motivated to use
`
`a side opening because it would more easily permit compatibility with a 5 French
`
`12
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`

`

`
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`GC, which has advantages over a 6 French GC.4 Id. ¶171.
`
`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-1806 ¶172.
`
`
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`Ex-1405 ¶193. A POSITA was motivated to make this modification, as PO’s
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`expert acknowledged, because “the larger the available area within a guiding
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`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
`
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`4 For compatibility with a 5 French GC, tube 16 would be molded onto a tapered
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`wire 14. § IV.E, infra.
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`13
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`

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`
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`of the extension catheter without causing a commensurate increase in the GC, PO
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`argues that a POSITA would not apply this teaching because Kontos requires a
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`“snug” fit. POR, 26. But as discussed above, Kontos does not mandate such a tight
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`fit. § III, supra.
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`PO also argues that it would not be possible to increase the diameter of body
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`12 without also increasing the diameter of the GC due to Kontos’s raised marker
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`bands. POR, 27. Kontos teaches, however, that “[o]f course, numerous other
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`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
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`in the art. Ex-1806 ¶173; Ex-1762, 56:3-23. PO’s expert agreed. Ex-1801, 66:19-
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`67:6, 70:5-17, 75:15-19. It was well within the skill of a POSITA to recess the
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`marker bands (Ex-1807 ¶¶168-82). PO cannot defeat Petitioners showing that a
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`POSITA would, based on the teachings of Adams,5 replace Kontos’s funnel with a
`
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`5 Contrary to PO’s argument, POR, 31-32, 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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`14
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`side opening.
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`2.
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`Petitioner’s other motivations are not based in hindsight.
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`As set forth in the Petition and as taught by Ressemann, side openings
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`“facilitate smooth[] passage of other therapeutic devices” into the lumen of the
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`child catheter. Ex-1408, 6:52-57. PO tries to explain away this teaching by noting
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`Ressemann’s alternative embodiments use a flare or reverse bevel. POR, 28-29,
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`36-37. PO’s expert, though, acknowledged that Ressemann’s primary embodiment
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`does 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
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`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
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`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
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`navigates the vasculature. Pet., 45. PO argues, though, that this teaching is
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`“unsupported by the evidence.” POR, 37. PO is wrong. Not only does Ressemann
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`explicitly state that a side opening “allow[s] for smoother passage,” but an
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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.
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`15
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`identical teaching is also recited in Keith. Ex-1123, 7:54-60. Further, in prior
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`litigation, PO’s expert, Mr. Keith, argued that
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`
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`” Ex-1819 ¶112.
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`Finally, a side opening permits smooth re-entry when the extension catheter
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`is extended beyond the distal end of the GC. Pet., 45-46. PO’s expert previously
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`found himself in that situation (i.e., passed an extension catheter entirely outside of
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`the GC),6 Ex-1801, 72:10-73:18, and agreed that a proximal opening, as opposed to
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`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.
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`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
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`problems. POR, 26-30. 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
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`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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`6 PO is incorrect to argue that “Kontos teaches that generally it is not desirable to
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`extend the proximal end of body 12 beyond the distal end of the guide catheter.”
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`POR, 37. PO ignores Figure 7, which teaches the intentional advancement into the
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`vasculature. Ex-1409, 6:19-28.
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`16
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`
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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
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`assembly 10 and the inner diameter of the GC would be 0.005 inches. Given that a
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`guidewire or the distal-most wire of a fixed-wire balloon typically have a 0.014
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`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 ¶¶174-77.
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`
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`Ex-1409, Fig. 1 (modified by Petitioner).
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`Ressemann and Keith buttress this conclusion. Ex-1806 ¶178. Both
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`references teach side openings that are “preferably angled” to “facilitate smoother
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`passage of other therapeutic devices,” and both teach a gap of at least 0.009 inches
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`as shown below. Ex-1806 ¶179. This is almost double Kontos’s alleged
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`“problematic” gap. Id.
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`17
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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 ¶179
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`3.
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`After replacing the funnel with a side opening, support
`catheter 10 would remain coaxial with the GC.
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`PO next argues that after replacing the funnel with a side opening, the lumen
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`of tube 16 and the GC would not be coaxial. POR, 39. PO’s argument fails because
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`it requires an overly-exacting definition of coaxial. Even under PO’s construction,
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`Kontos is coaxial.
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`Based on the intrinsic and extrinsic record, as used in the Teleflex patents,
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`coaxial means that “the axis of the lumen of the guide extension catheter is aligned
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`in the same direction as the axis of lumen of the guide catheter.” Ex-1806 ¶¶15-26.
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`Under this definition, Kontos remains coaxial if its proximal funnel is replaced by
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`a side opening. Ex-1806 ¶¶180-81. PO argues that coaxial means that the lumens
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`must be perfectly concentric, such that any deviation off axis—as shown below—
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`18
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`does not meet the claim limitation.
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`
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`POR, 39. Even if PO is correct, Kontos is still coaxial. Ex-1806 ¶182. Specifically,
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`Kontos teaches that “tube 16 may be molded directly onto application wire 14.”
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`Ex-1409, 4:31-32. In such a scenario, there would be no need for receiving hole 34
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`in base portion 18. Ex-1807 ¶¶177-79. A POSITA would be motivated to taper
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`wire 14 for attachment to tube 16, because this would optimize Kontos by either
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`permitting (i) use with a 5 French GC or (ii) a larger diameter for body 12.
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`§ IV.C.1, supra.
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`D. Claim 6: Kontos-Adams combination teaches a flexible cylindrical
`reinforced portion.
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`PO argues that the identified flexible cylindrical reinforced portion
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`(“FCRP”) is not “cylindrical” because it has an irregularly shaped outer diameter.
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`POR, 41-42. PO points to nothing in the patent requiring perfect cylindricality, and
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`for the reasons identified in the Petition, Kontos teaches two different FCRPs. Pet.,
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`19
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`48-52. At all times, the inner diameter—the portion of tube 16 that receives the
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`IVCD—is perfectly cylindrical throughout the identified portion. Ex-1806 ¶185.
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`Finally, even accepting PO’s argument that FCRP requires perfect cylindricality on
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`both the inside and outside of tube 16, as shown below, Kontos still satisfies this
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`limitation.
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`Ex-1409, Fig. 1 (color and annotations added). A cross section, under PO’s
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`interpretation of the distal and proximal FCRP, is shown below in Figures 2 and 3,
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`respectively. Ex-1806 ¶186.
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`
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`Ex-1409, Figs. 2-3; Ex-1800, 155:21-156:7; Ex-1806 ¶187.
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`
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`20
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`E. Claims 8 & 17: Kontos-Adams-Takahashi combination teaches
`the not-more-than-one-French limitation.
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`PO does not dispute that Takahashi provides motivation to achieve a 1
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`French differential to increase back-up support. Ex-1801, 117:14-118:5. PO argues
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`that this motivation is inapplicable, though, because Kontos “teaches away from
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`maximizing the inner diameter.” POR, 44. As discussed above, PO is incorrect to
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`argue that Kontos requires a snug fitting body 12. § III, supra. Thus, a POSITA
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`was motivated to apply the teachings of Takahashi to increase back-up support.
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`Ex-1806 ¶¶189, 191.
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`PO also argues that a POSITA would not have an expectation of success to
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`modify Kontos to achieve the 1 French differential. POR, 45-46. PO is wrong. A
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`POSITA knew how to (i) replace the proximal funnel with a side opening and (ii)
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`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,
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`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
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`combination. Ex-1807 ¶¶183-95. These modifications permit the diameter of tube
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`16 to be increased (Ex-1409, 4:46-50), and Kontos would achieve the not-more-
`
`than-one-French differential. Ex-1806 ¶¶190, 192.
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`21
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`Ex-1409, Fig. 1 (modified by Petitioner).
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`F. Claim 20: Kontos-Adams-Berg combination teaches the recited
`PSIs.
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`PO dismisses the teachings of Berg by arguing that they are directed to
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`different devices. In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). PO does