Paper No. __________
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`
`
`
`MEDTRONIC, INC.
`
`Petitioner,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`
`Patent Owner
`_____________________________
`Case No: IPR2020-00132
`U.S. Patent No. RE45,760E
`______________________________
`
`PETITIONER’S REPLY
`
`

`

`TABLE OF CONTENTS
`
`Page
`TABLE OF CONTENTS ............................................................................................ i
`
`TABLE OF AUTHORITIES .................................................................................... iii
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`II. GROUND 1: PO DOES NOT CHALLENGE THAT ITOU
`ANTICIPATES CLAIMS 25-31, 33-38, 41-42, 44 AND 47. ......................... 1
`
`III. GROUND 2: ITOU IN VIEW OF RESSEMANN RENDERS
`CLAIMS 32, 39 AND 40 OBVIOUS. ............................................................. 1
`
`A.
`
`PO does not challenge Medtronic’s evidence on the obviousness of
`claim 40. ................................................................................................ 1
`
`B.
`
`Claim 39 is rendered obvious by Itou in view of Ressemann. .............. 2
`
`1.
`
`2.
`
`Itou discloses a tubular structure configured to receive a “stent
`releasably joined to the distal end of [an] elongate balloon
`catheter.” ..................................................................................... 4
`
`The opening of Itou is actually larger, allowing larger devices
`through as well. ........................................................................... 5
`
`C.
`
`Claim 32 ................................................................................................ 7
`
`1.
`
`2.
`
`3.
`
`Adding “at least two inclined slopes” was not inventive. .......... 7
`
`Collar 2141 has more than two inclined slopes. ......................... 8
`
`Itou in view of Ressemann renders claim 32 obvious. ............. 10
`
`IV. GROUND 3: CLAIM 32 IS RENDERED OBVIOUS BY ITOU IN
`VIEW OF KATAISHI. ................................................................................... 15
`
`V.
`
`PO’S “COPYING” ALLEGATIONS DO NOT OVERCOME
`PETITIONER’S STRONG OBVIOUSNESS SHOWING. .......................... 19
`
`A.
`
`B.
`
`Side openings existed on prior art devices. ......................................... 20
`
`PO’s copying arguments are without merit. ........................................ 21
`
`
`
`i
`
`

`

`VI. AIA PATENT ................................................................................................. 24
`
`VII. CONCLUSION .............................................................................................. 25
`
`
`
`
`
`
`
`ii
`
`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`
`Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC,
`825 F.3d 1373 (Fed. Cir. 2016) .......................................................................... 10
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
`239 F.3d 1343 (Fed. Cir. 2001) .................................................................... 22, 23
`
`Google LLC v. Lee,
`759 F. App’x 992 (Fed. Cir. 2019) ..................................................................... 10
`
`In re Applied Materials
`692 F.3d 1289 (Fed. Cir. 2012) .......................................................................... 11
`
`In re Magna Elecs., Inc.,
`611 F. App’x 969 (Fed. Cir. 2015) ....................................................................... 7
`
`Johns Hopkins Univ. v. Datascope Corp.,
`543 F.3d 1342 (Fed. Cir. 2008) .......................................................................... 23
`
`KSR Int’l Co. v. Teleflex, Inc.
`550 U.S. 398 (2007) .......................................................................................... 1, 7
`
`Tyco Healthcare Grp. LP v. Ethicon Endo-Surgery, Inc.,
`774 F.3d 968 (Fed. Cir. 2014) .............................................................................. 3
`
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 20
`
`
`
`
`
`
`iii
`
`

`

`I.
`
`INTRODUCTION
`
`Patent Owner (“PO”) does not and cannot refute that Itou discloses each
`
`limitation of 17 of the 20 challenged claims (Compare Paper 1 (“Pet.”), 19-21 with
`
`Paper 44 (“POR”), 9-10), which are invalid as anticipated. PO only attempts to
`
`refute evidence that claims 32 and 39 are obvious. POR, 9-17. To do so, however,
`
`it must argue that a POSITA would never look to the teachings of one coronary
`
`catheter designed to remove unwanted material from the coronary vasculature,
`
`Ressemann (Ex-1008), to inform as to the use of a second, Itou (Ex-1007), which
`
`has exactly the same purpose. Itou and Ressemann are clearly analogous art, as
`
`obviousness inquiries properly take into account the “inferences and creative steps
`
`that a person of ordinary skill in the art would employ.” KSR Int’l Co. v. Teleflex,
`
`Inc. 550 U.S. 398, 418 (2007).
`
`II. GROUND 1: PO DOES NOT CHALLENGE THAT ITOU
`ANTICIPATES CLAIMS 25-31, 33-38, 41-42, 44 AND 47.
`
`As set forth in Paper 78, Itou is prior art.
`
`III. GROUND 2: ITOU IN VIEW OF RESSEMANN RENDERS CLAIMS
`32, 39 AND 40 OBVIOUS.
`
`A.
`
`PO does not challenge Medtronic’s evidence on the obviousness of
`claim 40.
`
`Similar to ground 1, PO has not challenged the disclosure of the art asserted
`
`against claim 40. It is obvious to use an “elongate balloon catheter,” as taught in
`
`Ressemann, with Itou’s catheter 2, as set forth in the Petition.
`
`
`
`1
`
`

`

`B. Claim 39 is rendered obvious by Itou in view of Ressemann.
`
`Like claim 40, it is also obvious to use an elongate balloon catheter with “a
`
`stent releasably joined to [its] distal end.” Ex-1001, 14:46-48. This is just another
`
`commonly known device that goes through a catheter, as explicitly taught in
`
`Ressemann. Ex-1008, 13:57-14:16; see id., Figs. 6E-F, 6H-I. There was ample
`
`motivation for a POSITA to use such a device with Itou, as well as a reasonable
`
`expectation of success. Pet., 68-71. Itou in view of Ressemann renders claim 39
`
`obvious while requiring not a single change to catheter (2)’s structure. See Pet.,
`
`21-38, 47-48.
`
`PO dismisses Itou’s disclosure because it teaches preassembly of catheters
`
`(2) and (5), while claim 39 recites the side opening receive a stent or balloon while
`
`it is positioned within the guide catheter, and while the extension catheter’s distal
`
`end is extended beyond the distal end of the guide catheter. Pet., 46. Itou’s
`
`disclosure is relevant for two reasons. First, it demonstrates that catheter (2) is long
`
`enough so that when its distal end extends from the guide catheter, its side opening
`
`remains in the guide catheter. Ex-1007, 5:35-42, Fig. 6, Table 1. Second, once
`
`catheter (2) is in place, catheter (5) may be withdrawn (Id., 7:16-19), which means
`
`that catheter (2)’s side opening is in just the right location to receive a “stent
`
`releasably joined” to a balloon catheter. Ex-1001, 4:46-48.
`
`
`
`2
`
`

`

`To the extent there is still a question about the motivation to look to
`
`Ressemann to modify Itou, Medtronic notes that Itou and Ressemann are clearly
`
`analogous art. See Tyco Healthcare Grp. LP v. Ethicon Endo-Surgery, Inc., 774
`
`F.3d 968, 979 (Fed. Cir. 2014).
`
`Itou discloses a suction catheter, while Ressemann teaches an embolic
`
`protection device that is also used to deliver a stent. Pet., 19-21, 56-61. The patent
`
`claims, Itou, and Ressemann all share the same field of endeavor, as they are all
`
`coronary catheters designed to provide solutions to the problem of coronary artery
`
`occlusion. Ex-1806 ¶¶ 64-74; see also Ex-1805, 20:7-21:1, 70:13-72:1. As Dr.
`
`Brecker explains, an interventional cardiologist would know that Itou’s catheter (2)
`
`could sequentially deploy a distal end protection device, deliver a stent, and then
`
`suction. And, given its structure, he would know that catheter (2) could be used
`
`solely to deliver a stent. Ex-1806 ¶¶ 75-76; see Ex-1811, Table 1.
`
`Inventor Root explained that the alleged invention of GuideLiner itself grew
`
`from prior work on a suction catheter. Ex-1762, 46:9-20. In fact, VSI used the
`
`same technology it used in its Pronto suction catheter to make GuideLiner’s distal
`
`tube. Id., 45:10-17.
`
`
`
`3
`
`

`

`1.
`
`Itou discloses a tubular structure configured to receive a “stent
`releasably joined to the distal end of [an] elongate balloon
`catheter.”
`
`If the “effective size” of Itou’s opening was 0.046 inches, as PO wrongly
`
`suggests, Itou still inherently discloses that catheter (2) is configured to receive a
`
`balloon-expandable stent, thereby satisfying the requirements of claim 39. Before
`
`the alleged invention of the ’760 patent, a POSITA was aware of numerous
`
`balloon-expandable stents that were deliverable through a catheter with an inner
`
`diameter (“ID”) of 0.046 inches. Ex-1806 ¶¶ 47-51; Ex-1015b, 189; Ex-1802, 4, 7,
`
`14-15, 21, 25; Ex-1803, 4:54-58; Ex-1804, Table 2, Fig. 3.
`
`At least three reasons demonstrate that PO cannot credibly argue otherwise.
`
`First, Mr. Keith, PO’s expert, admits that Itou teaches advancing catheter (2) into
`
`the coronary vasculature, so that the distal part of tubular structure (24) is extended
`
`into the vasculature, but the proximal opening remains within the guide catheter.
`
`Ex-1805, 137:7-138:16; Ex-1007, 5:35-42, 7:13-18.
`
`
`
`4
`
`
`
`

`

`
`
`Ex-1007, Fig. 6.
`
`Second, Keith also admits that a guidewire could be navigated into guiding
`
`catheter 1—and then through the guide catheter and right up to the opening of
`
`catheter (2)—but then has no idea whether it would be able to enter the opening.
`
`Ex-1805, 143:3-145:20.
`
`
`
`Ex-2138 ¶ 164 (modified).
`
`Third, Mr. Keith’s testimony is questionable, as the 5 French version of
`
`GuideLiner v.3 also has an ID of 0.046 inches and is marketed for delivering
`
`stents, which are, of course, much larger than a guidewire. Ex-2164, 5.
`
`2. The opening of Itou is actually larger, allowing larger devices
`through as well.
`
`Itou teaches an opening of .059 inches, not .046 as argued by PO. The
`
`teaching of Itou is correct because the fully circumferential portion of the pushwire
`
`
`
`5
`
`

`

`is not flush with the lumen, and the wire is flexible and bends in use. Ex-1806
`
`¶¶53-57; Ex-1807 ¶¶28-46.
`
`Catheter (2)’s angulated proximal opening presents its widest diameter at a
`
`substantial angle to wire 25, which tapers as it is welded to collar 231 (“crushed
`
`into a form of a flat plate”). The flattening of wire 25 means the fully-
`
`circumferential portion of wire (25) does not block catheter (2)’s proximal
`
`opening. Ex-1806 ¶56; Ex-1807 ¶¶35-39; see Ex-1114, 75:20-76:6 (
`
`
`
`).
`
`
`
`Additionally, Itou teaches that the distal portion of catheter (2) is
`
`emphatically not rigid, as it must be navigated into a coronary artery. Ex-1007,
`
`Abstract, Fig. 6, 5:35-42. This necessarily requires that the distal tubular portion of
`
`catheter (2) bend, as—if it did not—it could never be positioned where Itou
`
`instructs, which is “deep” in the coronary vasculature. Id., 1:66-2:5, 5:35-39, Fig.
`
`6; Ex-1806 ¶¶54-55; Ex-1807 ¶36.
`
`Collectively, the structure and flexibility of catheter (2) mean that the
`
`“effective size” of its’ opening is exactly what Itou teaches: 1.5 mm, or 0.059
`
`inches. Ex-1806 ¶¶53-54; Ex-1807 ¶¶30-39.
`
`
`
`6
`
`

`

`C. Claim 32
`
`Claim 32 adds that “the segment defining the side opening includes at least
`
`two inclined slopes. Ex-1001, 10:51-11:21.
`
`1. Adding “at least two inclined slopes” was not inventive.
`
`PO’s inventors and experts admit that the various iterations of the double-
`
`incline configuration are not important, and provide no benefit over a single
`
`incline.
`
`
`
`. Ex-1108, 75:12-76:1. Similarly, Root testified that a
`
`wide variety of side opening configurations all worked for their intended purpose,
`
`and that there was no difference between the various iterations. Ex-1762, 79:17-
`
`80:12, 91:2-19, 115:6-14, 280:22-210:21. And both PO experts struggled to find an
`
`advantage for the double incline in practice—GuideLiner version 2 had only a
`
`single incline (Ex-1800, 49:7-14)—or the patents. Ex-1813, 48:16-49:3, 98:5-15;
`
`Ex-1800, 39:1-41:18, 49:15-51:21, 55:12-58:15; Ex-1817, 60:10-62:5, 63:10-23.
`
`As a result, adding a second incline to the proximal opening constitutes “the
`
`predictable use of prior art elements according to their established functions.” See
`
`KSR, 550 U.S. at 417; see also In re Magna Elecs., Inc., 611 F. App’x 969, 974
`
`(Fed. Cir. 2015) (finding that “short horizontal lines provide the same information
`
`and functionality as long horizontal lines, and cannot be used as a distinguishing
`
`
`
`7
`
`

`

`factor to render the claims nonobvious”). Regardless, as set forth below, the
`
`claimed inclines are present in the art and obvious.
`
`2. Collar 2141 has more than two inclined slopes.
`
`PO states that GuideLiner version 1 has three inclines. Thus, collar 2141
`
`also has at least three inclines. Ex-1806 ¶87.
`
`Keith testified that he identifies where an 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 3 has “a
`
`shallower quality” to it, and “somewhere in between there is what goes from one to
`
`the next” is incline 2. Ex-1800, 45:21-46:2. His opinion is that even shallow
`
`inclines are inclines so long as they can be identified relative to the catheter’s
`
`longitudinal axis. Id., 47:3-8.
`
`Ex-1122 (color added to arrows for visibility).
`
`
`
`
`
`8
`
`

`

`Similarly, Root testifies that the figure below shows two inclines that are
`
`separated by a flat section. Ex-1762, 91:24-93:24.
`
`Ex-1116 (bottom annotation added to show inclined regions (red) and flat region
`
`
`
`(blue)).
`
`In light of PO’s witness testimony, the Ressemann collar must have more
`
`than two inclines. As shown below, support collar 2141 has at least an incline (C)
`
`that is just proximal to its fully circumferential portion, an incline (B)
`
`corresponding to the curve between 2141a and 2141b (similar to the curve in Fig. 4
`
`of the patent), and an incline (A) at the curved portion of tab 2141b. Ex-1806 ¶¶80-
`
`91.
`
`
`
`9
`
`

`

`
`
`Ex-1008, Fig. 16J (annotated); see Ex-2138 ¶¶140, 148, 152 (Keith’s various 3D
`
`renderings of collar 2141 showing at least a third incline).
`
`3.
`
`Itou in view of Ressemann renders claim 32 obvious.
`
`PO argues that a POSITA would not have been motivated to combine
`
`Ressemann’s collar 2141 with Itou’s suction catheter 2 because in its assembled
`
`state, Ressemann does not teach this configuration of collar 2141. POR, 22-31.
`
`This is not sufficient to overcome Petitioner’s showing of obviousness. Allied
`
`Erecting & Dismantling Co. v. Genesis Attachments, LLC, 825 F.3d 1373, 1380-81
`
`(Fed. Cir. 2016) (explaining that claims can be obvious even if a prior art
`
`combination requires “substantial redesign and reconstruction” of a reference). The
`
`law simply does not require that a component from reference A be combined with
`
`reference B in exactly the same way as is taught in reference A. Google LLC v.
`
`Lee, 759 F. App’x 992, 997 (Fed. Cir. 2019) (“Our obviousness framework permits
`
`modifying one reference and combining it with a second reference.”). And that is
`
`
`
`10
`
`

`

`because a “reference must be considered for everything that it teaches, not simply
`
`the described invention or a preferred embodiment.” In re Applied Materials 692
`
`F.3d 1289, 1298 (Fed. Cir. 2012) (emphasis added).
`
`PO actually does not dispute the first motivation to combine collar 2141
`
`with Itou – larger area of entry for devices. PO argues that not all double inclined
`
`openings have a larger area of entry. But it is undisputed that collar 2141 does have
`
`a larger area, and that a larger opening is beneficial for receiving stent and balloon
`
`catheters. Compare Pet., 66 with POR, 24-29. As Petitioner has proposed to modify
`
`Itou, collar 2141 would increase the area of entry to catheter (2) to over three times
`
`its size. Ex-1807 ¶125. Moreover, the combination is easy because tab 2141b could
`
`be welded to wire (25), just as Itou teaches welding collar 23 to wire 25. Ex-1007,
`
`4:33-36. Keith admits this would be a matter of routine engineering. Ex-1800,
`
`48:5-49:5. Double incline claims are obvious on this basis alone.
`
`PO also argues that a POSITA would not have been motivated to add collar
`
`2141 to catheter (2) to reinforce its opening, because Itou’s metal collar is thicker
`
`than the preferred embodiment of Ressemann. POR, 35. But this is actually another
`
`reason to do it. The Ressemann walls are half as thick. Id.; see Ex-2138 ¶144-46
`
`(comparing Itou’s 0.0043 inch wall thickness to Ressemann’s 0.002 inch
`
`thickness); Ex-1805, 180:17-181:4. This is beneficial as the collar would still
`
`
`
`11
`
`

`

`provide reinforcement but be less bulky, Ex-1807 ¶126; Ex-1806 ¶89, ensuring an
`
`increased area of opening.
`
`An independent reason to combine is to provide a flexibility transition not
`
`present in Itou. Collar 2141’s tab 2141b provides the opportunity to improve on
`
`Itou’s weld point, providing a flexibility transition by extending wire 25 under the
`
`tab.
`
`Itou explains that the weld point is crushed into the form of a flat plate
`
`(Ex-1007, 4:33-36), which creates a potential weakness point. Ex-1813, 161:4-10.
`
`A POSITA understands that crushing a solid metal wire into a flat plate decreases
`
`the metal’s ductility at that location. Ex-1807 ¶127; Ex-1818, 117-18, 121-23. And
`
`because decreasing ductility at critical stiffness transition points is known in the art
`
`to create the risk of kinking, a POSITA had the motivation to look to alternative
`
`options that would have less risk of failure. Ex-1807 ¶127.
`
`Itou’s weld point is located at a critical stiffness transition point, where
`
`“substantially rigid” wire (25) transitions into tubular portion (24). Ex-1005 ¶¶151,
`
`185-87, 197-202, 207-13; Ex-1042 ¶¶27, 64-84; Ex-1807 ¶¶52-66, 127-128, 210.
`
`Before the Teleflex patent, it was widely appreciated that rapid exchange catheters
`
`were susceptible to kinking at the “interface between the stiff proximal portion and
`
`the flexible distal portion due to the change in stiffness at this interface,” and
`
`
`
`12
`
`

`

`various ways were known to address the interface. Ex-1816, 2:41-45; Ex-1807
`
`¶¶52-66, 127-128, 210.
`
`Here, PO does not dispute the flexibility transitions of catheter (2). POR, 43-
`
`45. Nor does its expert have an opinion on them. Ex-1805, 124:9-129:3; 131:11-
`
`132:13. As discussed above, a POSITA knew that transitional regions in catheter
`
`flexibility could be improved upon. This is the very point of tab 2141 of
`
`Ressemann’s collar. Ex-1008, 24:64-67; Ex-1807 ¶¶48, 128, 103.
`
`PO also argues that a POSITA would have recognized the problems created
`
`by placing Ressemann’s support collar atop catheter (2)’s wire (25). POR, 41-42.
`
`Specifically, PO argues that the proposed modification would (i) create a catch-
`
`point and (ii) be “complex” because convex up metal tab to a convex down shaft
`
`would have to be bonded. Id. Both arguments fail.
`
`As is standard practice in the art—and as explicitly taught by Ressemann
`
`(Ex-1008, 7:28-39, 24:2-11)—support collar 2141 would be encased in a polymer
`
`jacket. Ex-1807 ¶¶90-96, 129-132. In the 2D rendering of a 3D structure, below,
`
`Itou’s tubular portion (yellow) is shown, and collar 2141 is embedded between the
`
`tubular structure’s resin layers, similar to Itou’s collar 23. Proximal of the tubular
`
`portion, tab 2141 b extends along the top of wire-like portion (25), secured by
`
`polymer (red). Ex-1807 ¶¶130-132.
`
`
`
`13
`
`

`

`Id. ¶130.
`
`
`
`In so doing, as shown above, the proposed modification would have no
`
`catch-points, and the shape of the collar—specifically at least two inclined
`
`slopes—would be retained and be present in the opening of catheter 2. Ex-1807
`
`¶¶130-132. This is the case if tab 2141b is incorporated atop of wire (25), as
`
`illustrated above, in which case inclines A, B, and C are part of the segment
`
`defining the side opening. It is also the case even if, as PO suggests, tab 2141b is
`
`incorporated underneath wire (25) (POR, 40), in which case at least inclines B and
`
`C are part of the segment defining the side opening. In fact, as Dr. Brecker opines,
`
`there is another incline between inclines B and C. Ex-1806 ¶88.
`
`PO also incorrectly argues that the “convex up” and “convex down”
`
`arrangement would cause the proposed modification to “pop” loose. POR, 41.
`
`Indeed, numerous examples, including those cited on the face of the PO patent
`
`(e.g., Ex-1030), teach catheter assemblies with portions having convex up (distal
`
`lumen) and convex down components (pushrod). Ex-1807 ¶¶93-96. Thus, there
`
`
`
`14
`
`

`

`was a reasonable expectation of success in making the proposed modification, and
`
`claim 32 is rendered obvious by Itou in view of Ressemann.
`
`Finally, PO is incorrect in asserting that using Ressemann’s collar in Itou
`
`would eliminate the 1 Fr differential between guide catheter (1) and catheter (2).
`
`POR, 43-45. Itou teaches a metal collar that is between two layers of polymer (i.e.
`
`“within” the walls of suction catheter (2)). Ex-1007, 4:36-38. There would be no
`
`reason that the circumferential portion of collar 2141 would not be similarly
`
`positioned. Ex-1807 ¶129. And, as collar 2141 is thinner than metal collar 23,
`
`using the former instead of the latter increases the ID of catheter (2). Ex-1807
`
`¶¶126, 129. An increase in the ID of catheter 2 by 0.0046 inches is an increase of
`
`0.11 mm. Thus, catheter 2’s modified ID is 1.61 mm, and the differential between
`
`the lumen of modified catheter 2 and guide catheter 1 is 0.19 mm, which is less
`
`than 1 French. Ex-1062, 545. Claim 39 is also obvious.
`
`IV. GROUND 3: CLAIM 32 IS RENDERED OBVIOUS BY ITOU IN
`VIEW OF KATAISHI.
`
`A POSITA was motivated to combine the shape of Kataishi’s distal opening
`
`with Itou’s proximal opening. Pet., 73-78. Specifically, adding Kataishi’s shape to
`
`Itou’s proximal opening would have improved loading of interventional devices
`
`and improved crossability of the catheter. Id. PO is incorrect to argue otherwise.
`
`PO argues that the benefits of Kataishi’s distal tip do not apply equally to
`
`Itou’s proximal opening. POR, 51. This is belied by explicit teachings in
`
`
`
`15
`
`

`

`Ressemann— and in a patent by their own expert, Mr. Keith—that explain that
`
`the shape of a lumen’s opening functions similarly, regardless of whether it is
`
`placed at the distal end or the proximal end.
`
`The proximal and distal ends 140a, 140b of the evacuation lumen 140
`
`are preferably angled to allow for smoother passage of the evacuation
`
`sheath assembly 100 through a guide catheter, and into a blood vessel,
`
`and to facilitate smoother passage of other therapeutic devices
`
`through the evacuation lumen 140 of the evacuation head 132. The
`
`larger area of the angled open ends also allows for larger deformable
`
`particulate matter to pass through the lumen more smoothly.
`
`Ex-1008, 6:52-60 (emphasis added).
`
`
`
`Id., Fig. 1A; see Ex-1800, 140:18-143:7, 146:16-147:8,148:21-149:14.
`
`PO’s own expert, Mr. Keith, is a named inventor on a related patent, which
`
`contains the verbatim teaching that the shape of both the distal and proximal
`
`opening can improve suction of particulate matter. Ex-1123, 7:54-60; Ex-1800,
`
`149:3-18. The larger area of the angled openings is beneficial both for suctioning
`
`“larger deformable particular matter” as well as for introducing a therapy catheter,
`
`
`
`16
`
`

`

`such as a balloon-expandable stent. Ex-1800, 149:3-8; see Ex-1008, Figs. 6E, 6G,
`
`13:57:14-14:26. 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 or Itou. Ex-1807
`
`¶¶133-143; Ex-1806 ¶96. The shape of Kataishi’s opening increases the area of the
`
`proximal opening as compared to Itou’s opening. Ex-1807 ¶146.
`
`Id. (Schematic illustrating relative area of Itou’s proximal opening as shown in
`
`
`
`(Ex-1007, Fig. 3) versus Kataishi’s proximal opening (Ex-1025, Fig. 12)).
`
`And an increase in the area of opening makes it easier to introduce a stent or
`
`balloon catheter. Ex-1005 ¶¶283-90; Ex-1042 ¶¶104-112; Ex-1807 ¶¶136-138;
`
`Ex-1005 ¶¶287-289.
`
`
`
`17
`
`

`

`PO is also incorrect to argue that adding Kataishi’s shape to Itou’s proximal
`
`opening would not improve catheter crossability. POR, 51-52. 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-1008, 6:52-57; Ex-1123, 7:54-60. Further, PO is
`
`incorrect to argue that “crossability” is limited to the suction catheter’s ability to
`
`“extend[] past the end of the guide catheter through tortuous vasculature.” POR,
`
`51. Indeed, Sakurada, which tested the Kataishi device, performed a “passing
`
`ability test” that measured “[t]he length between the ostium and the distal tip of the
`
`aspiration catheter,” and found that Kataishi’s shape had improved crossability. Ex-
`
`1055, 300-02. And it is this improved crossability that prevents kinking (i.e.,
`
`catheter kink when encountering an unnavigable portion of the vasculature). Ex-
`
`1807 ¶¶52-66, 139-142, 210. A POSITA appreciates that modifying Itou’s proximal
`
`opening to include the shape of Kataishi’s distal tip was an obvious modification.
`
`Ex-1806 ¶¶92-98.
`
`PO further argues that Kataishi’s benefits—that allegedly flow from both its
`
`shape and flexibility of the material—is inapplicable to Ressemann’s collar. PO is
`
`again belied by its own expert witness, who testified that once a shape is provided,
`
`a POSITA would readily use routine engineering to create side openings of several
`
`
`
`18
`
`

`

`different materials, some more rigid and some more flexible. Ex-1764, 27:9-17,
`
`30:2-8, 31:16-21.
`
`V.
`
`PO’S “COPYING” ALLEGATIONS DO NOT OVERCOME
`PETITIONER’S STRONG OBVIOUSNESS SHOWING.
`
`The earliest rapid exchange (“Rx”) GEC in the record is Kontos, followed
`
`by Ressemann and Itou. These devices are Rx, configured to deliver a wide variety
`
`of IVCDs, and provide increased back up support when extended partially past the
`
`end of a GC as intended. These devices—and the functionality associated with
`
`them—were all published in the art in advance of the 2004 Transcatheter
`
`Cardiovascular Therapeutics conference, where inventor Root maintains he
`
`conceived of the idea claimed in the Teleflex patents.1 Compare Ex-1755 ¶¶27-38
`
`with Ex-2118 ¶¶5-6; see also Ex-1806 ¶¶205-219; Ex-2138 ¶71; Ex-2145 ¶82;
`
`Ex-1762, 39:1-22; Ex-1114, 111:13-17; Ex-1800, 16:22-17:1; Ex-1762, 194:4-16;
`
`Ex-1817, 25:20-26:9, 63:10-64:8; Ex-2215 ¶22; Ex-1820, 23:15-26:22, 36:3-10;
`
`Ex-2123 ¶20.
`
`PO bases its entire secondary considerations case on alleged copying of
`
`claim 32—a dependent claims that recites a side opening adapted to receive IVCDs
`
`
`1
`
`
`
`. Ex-1762, 39:19-21,
`
`67:23-68:1; Ex-2003; Ex-1114, 61:24-62:9, 77:9-15, 121:12-122:1.
`
`
`
`19
`
`

`

`with “at least two inclined slopes.” POR, 60-67. Support collar 2141 of Ressemann
`
`discloses or teaches a device with at least two inclined slopes. Itou discloses a side
`
`opening, and the only potential obviousness issue is whether it would be obvious to
`
`add another inclined slope to Itou’s side opening. PO cannot overcome Petitioner’s
`
`strong showing of obviousness. ZUP, LLC v. Nash Mfg., Inc., 896 F.3d 1365, 1374
`
`(Fed. Cir. 2018) (“[A] strong showing of obviousness may stand even in the face of
`
`considerable evidence of secondary considerations.”).
`
`A.
`
`Side openings existed on prior art devices.
`
`Side openings existed in the prior art, including prior art devices presented in
`
`these IPRs.
`
`
`
`. Ex-1108, 75:13-18. And PO’s experts were unable to identify particular
`
`advantages to one form of side opening over another. Ex-1800, 39:1-15 (single
`
`incline versus double incline achieve same identified benefits); Ex-1813, 49:4-7
`
`(GuideLiner V2 and V3, with differing side openings, “work the same” if used
`
`“appropriately, as intended”), 94:8-14; see also Ex-1806 ¶205-219.
`
`
`
`
`
`
`
` Ex-1822, 28-29; see
`
`also Ex-1823, 31.
`
`
`
`20
`
`

`

`B.
`
`PO’s copying arguments are without merit.
`
`As an initial matter, neither Telescope nor GuideLiner practice Claim 53 of
`
`the ’776 patent. As admitted by Inventor Root,
`
`. Ex-1115, 154:14-155:4. Further, PO’s own expert previously testified that
`
`“[m]athmatically, those of ordinary skill in the art define one French as .0131
`
`inches.” Ex-1825 ¶¶43-48 (testifying that Booting Catheter infringes due to the
`
`0.0131 difference); see also Ex-1844, 27:3-9 (Judge Schiltz noting that PO’s
`
`attorneys “stood before [him] in QX Medical and told [him] one French meant
`
`0.00131 inches”).
`
`But the difference for both GuideLiner and Telescope is 0.014 inches.
`
`
`
`
`
`
`
`Ex-1082 Ex-A, 39. The District Court recognized as much at the preliminary
`
`injunction hearing. Ex-1844, 31:8-11 (“I just have to say that I give you kudos for
`
`
`
`21
`
`

`

`your creativity [that 1 French means more than 0.0131 inches]. You’re going to be
`
`walking uphill for me on that argument.”).
`
`Further, PO’s “copying” arguments erroneously compare competing
`
`products to various versions of GuideLiner, ignoring the fact that the side opening
`
`described in claim 32 is disclosed or taught in the prior art. Amazon.com, Inc. v.
`
`Barnesandnoble.com, Inc., 239 F.3d 1343, 1366 (Fed. Cir. 2001) (“[E]vidence of
`
`copying by [defendant] and others is not sufficient to demonstrate nonobviousness
`
`of the claimed invention, in view of the substantial question of validity raised by
`
`the prior art references.”).
`
`Like Itou and Ressemann, Guidezilla and The Boosting Catheter are Rx
`
`devices configured to deliver a wide variety of IVCDs and provide increased
`
`backup support when extended partially past the end of a GC. Compare Ex-2046
`
`¶¶70-71 and Ex-2056 ¶¶73-74, with Ex-1007, 4:27-32, Figs. 3-5; Ex-1008
`
`Abstract, 6:18-24, 12:9-14:39, Figs. 6A-6F. Guidezilla2 and The Boosting Catheter
`
`
`2 PO provides no context surrounding its license with Boston Scientific, and it has
`
`not made the license of record. See Iron Grip Barbell Co. v. USA Sports, Inc., 392
`
`F.3d 1317, 1324 (Fed. Cir. 2004) (licenses entitled to little weight “if the patentee
`
`does not demonstrate a nexus between the merits of the invention and the licenses
`
`of record.”) PO and Boston Scientific entered into a settlement agreement and
`
`
`
`22
`
`

`

`have a side opening with more than one incline, like Support Collar 2141 of
`
`Ressemann. Id.
`
`Telescope practices the prior art. 3 Compare Ex-2071, 10, 35 with Ex-1007,
`
`Figs. 3-5, 4:27-32; Ex-1008, Abstract, Figs. 6A-6F, 6:18-24, 12:9-14:39.
`
`PO’s copying argument focuses on Petitioner’s alleged copying of GuideLiner’s
`
`“half-pipe”—a design element only present in the third version of GuideLiner.
`
`POR, 64-67. Telescope does not copy GuideLiner’s “half-pipe.” As Dr. Zalesky
`
`explains the entry ports for inserted therapeutic devices are substantially different
`
`for the two devices. Ex-1830 ¶3-27. Even PO acknowledges that “GuideLiner V3
`
`has a longer side opening with a third inclined region between the two incline
`
`
`terminated their litigation in August 2014 (Ex-2044 ¶34), less than three months
`
`after Boston Scientific filed four petitions for IPR against PO’s alleged GuideLiner
`
`patents. See IPR2014-00759, -760, -762, -763.
`
`3 PO’s suggestion that regulatory approval supports copying is wrong. “FDA
`
`equivalence is irrelevant to patent law because it involves fundamentally different
`
`inquiries.” Johns Hopkins Univ. v. Datascope Corp., 543 F.3d 1342, 1349 n.3 (Fed.
`
`Cir. 2008); see also Ex-1077, 22:3-20 (regulatory equivalence does not equate to
`
`copying).
`
`
`
`23
`
`

`

`regions.” POR, 66; see also Ex-1821, 233:10-23, 236:16-21 (
`
`
`
`).
`
`PO’s “copying” arguments ignore other important differences between
`
`GuideLiner and Telescope. Ex-1830 ¶3-27. PO invites the Board to look at the
`
`parties’ products “side by side,” while ignoring the alleged “small differences,”
`
`including “Telescope’s hydrophilic coating and round push wire.” POR, 65-66.