Paper No. __________
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`
`Petitioner,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`
`Patent Owner
`_____________________________
`Case No: IPR2020-00138
`U.S. Patent No. RE47,379
`______________________________
`
`PETITIONER’S REPLY
`
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`___________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`__________________________
`
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`
`Petitioner,
`
`v.
`
`TELEFLEX INNOVATIONS S.À.R.L.,
`
`Patent Owner
`_____________________________
`Case No: IPR2020-00138
`U.S. Patent No. RE47,379
`______________________________
`
`PETITIONER’S REPLY
`
`
`
`TABLE OF CONTENTS
`
`I.
`
`II.
`
`Page
`INTRODUCTION ............................................................................................ 1
`
`PO DOES NOT DISPUTE MEDTRONIC’S EVIDENCE FOR 14 OF
`18 CHALLENGED CLAIMS. ......................................................................... 1
`
` GROUND 1: PO does not challenge that Ressemann discloses
`each and every limitation of claims 25-26, 29-31, 36, 38-40, 43
`or 45. ...................................................................................................... 1
`
` GROUND 3: Ressemann in view of the knowledge of a
`POSITA renders obvious claims 32, 35 and 37. .................................... 1
`
`III. GROUND 2: CLAIMS 42 AND 44 ................................................................. 2
`
`
`
`
`
`
`
`The claimed shape of the opening was not inventive. .......................... 2
`
`Ressemann’s collar 2141 has a first inclined side wall and a
`second inclined sidewall separated by a non-inclined region. .............. 3
`
`Ressemann renders claims 42 and 44 obvious. ..................................... 5
`
`IV. GROUND 3: RESSEMANN IN VIEW OF TAKAHASHI RENDERS
`CLAIMS 33 AND 34 OBVIOUS. .................................................................. 10
`
`V. GROUND 4: RESSEMANN IN VIEW OF KATAISHI RENDERS
`CLAIM 44 OBVIOUS. .................................................................................. 14
`
`VI. PO ASSERTS SECONDARY CONSIDERATIONS BASED UPON
`SOMETHING IT DID NOT INVENT—A RAPID-EXCHANGE
`VERSION OF A GUIDE EXTENSION CATHETER. .................................. 18
`
` Mother-in-Child and Rx Devices were Well Known, and so was
`the Combination. ................................................................................. 20
`
`
`
`
`
`PO’s Secondary Consideration Evidence All Relates to Prior
`Art Features and Functionality. ........................................................... 21
`
`PO’s “Copying” Allegations are Without Merit. ................................ 21
`
`
`
`i
`
`
`
`1.
`
`2.
`
`3.
`
`4.
`
`Neither GuideLiner nor Telescope practice Claim 33. ............ 21
`
`Side openings existed on prior art devices............................... 23
`
`Claim 44 did not exist until May 2019—years after
`Medtronic began working on Telescope. ................................. 24
`
`PO presents an incorrect and incomplete comparison of
`Telescope and Version 3 of GuideLiner. .................................. 25
`
`VII. CONCLUSION .............................................................................................. 26
`
`
`
`
`
`
`
`ii
`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`
`Allied Erecting & Dismantling Co. v. Genesis Attachments, LLC,
`825 F.3d 1373 (Fed. Cir. 2016) ............................................................................ 6
`
`Google LLC v. Lee,
`759 F. App’x 992 (Fed. Cir. 2019) ....................................................................... 6
`
`In re Applied Materials,
`692 F.3d 1289 (Fed. Cir. 2012) ............................................................................ 8
`
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .......................................................................... 19
`
`In re Magna Elecs., Inc.,
`611 F. App’x 969 (Fed. Cir. 2015) ....................................................................... 2
`
`Johns Hopkins Univ. v. Datascope Corp.,
`543 F.3d 1342 (Fed. Cir. 2008) .......................................................................... 25
`
`KSR Int’l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .............................................................................................. 2
`
`Liqwd, Inc. v. L’Oreal USA, Inc.,
`941 F.3d 1133 (Fed. Cir. 2019) .......................................................................... 24
`
`Ormco Corp. v. Align Tech., Inc.,
`463 F.3d 1299 (Fed. Cir. 2006) .................................................................... 21, 24
`
`Raytheon Co. v. Sony Corp.,
`727 Fed. Appx. 662 (Fed. Cir. 2018) .................................................................. 11
`
`Sakraida v. Ag Pro, Inc.,
`425 U.S. 273 (1976) ............................................................................................ 19
`
`Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC,
`683 F.3d 1356 (Fed. Cir. 2012) .......................................................................... 24
`
`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 Ressemann discloses
`
`each and every limitation of 11 of the 18 challenged claims, compare Paper 1
`
`(“Pet.”) with Paper 40 (“POR”), which are invalid as anticipated. Nor does it refute
`
`that Ressemann renders obvious three additional claims. Id. PO only attempts to
`
`refute evidence that four of the 18 claims are obvious. Id. But these claims add
`
`unremarkable limitations related to the rigidity or shape of the side opening of the
`
`extension catheter, or to the relative sizes of the lumens of the extension and guide
`
`catheters, none of which is inventive.
`
`II.
`
`PO DOES NOT DISPUTE MEDTRONIC’S EVIDENCE FOR 14 OF 18
`CHALLENGED CLAIMS.
`
` GROUND 1: PO does not challenge that Ressemann discloses
`each and every limitation of claims 25-26, 29-31, 36, 38-40, 43 or
`45.
`
`For the reasons set forth in Medtronic’s petition, these claims are anticipated
`
`by Ressemann. Compare Pet., 19-58, with POR, 9-23.
`
` GROUND 3: Ressemann in view of the knowledge of a POSITA
`renders obvious claims 32, 35 and 37.
`
`Similar to Ground 1, PO has not challenged that the prior art renders obvious
`
`claims 32, 35 or 37. Thus, it is obvious to include a 20-30 cm length of reinforcing
`
`braid or coil in a coronary catheter (claim 32), line a catheter with
`
`polytetrafluoroethylene (PTFE) (claim 35), or cover radiopaque marker bands with
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`polymer (claim 37). Pet., 61-65, 66-67.
`
`
`
`1
`
`
`
`III. GROUND 2: CLAIMS 42 AND 44
`
` The claimed shape of the opening was not inventive.
`
`Claim 44 adds that “defining the side opening portion includes forming a
`
`first inclined side wall, forming a second inclined side wall, and separating the first
`
`inclined sidewall and the second inclined sidewall by a non-inclined region.”
`
`Ex-1201, 16:23-27. But 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, 79:19-80:12; 91:2-19; 115:6-14; 209:2-210:21. And
`
`PO’s experts struggled to find an advantage for two inclines in practice—
`
`GuideLiner version 2 had only a single incline, Ex-1800, 49:7-14—or the patents.
`
`Ex-1813, 49:2-3; 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, the addition of two inclined sidewalls,
`
`separated by a non-inclined region, to the proximal opening constitutes “the
`
`predictable use of prior art elements according to their established functions.” See
`
`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007); see also In re Magna
`
`Elecs., Inc., 611 F. App’x 969, 974 (Fed. Cir. 2015) (finding that “short horizontal
`
`
`
`2
`
`
`
`lines provide the same information and functionality as long horizontal lines, and
`
`cannot be used as a distinguishing factor to render the claims nonobvious.”).
`
`Regardless, as set forth below, the claimed shape to the opening is present in the art
`
`and obvious.
`
` Ressemann’s collar 2141 has a first inclined side wall and a
`second inclined sidewall separated by a non-inclined region.
`
`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, there are three inclines. Incline 1 has a “relatively steeper quality” to it, and
`
`incline 3 has “a shallower quality” to it, and “somewhere in between there is where
`
`that 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., 47:3-19.
`
`Ex-1122 (color added to arrows for visibility).
`
`
`
`3
`
`
`
`
`
`Similarly, Root testifies that the figure below shows two inclines that are
`
`separated by a flat section. Ex-1762, 92:1-93:25.
`
`Ex-1116 (bottom annotation added to show inclined regions (red) and flat region
`
`
`
`(blue)).
`
`In light of PO’s witness testimony, the Ressemann collar 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 ¶¶81-
`
`88.
`
`
`
`4
`
`
`
`
`
`Ex-1208, Fig. 16J (annotated); see Ex-2138 ¶¶138, 146, 148 (Keith’s various 3D
`
`renderings of collar 2141 showing at least a third incline).
`
`Moreover, inclines (A) and (B) are separated by a non-inclined region
`
`(dotted line). Ex-1806 ¶90.
`
` Ressemann renders claims 42 and 44 obvious.
`
`PO argues that a POSITA would not have been motivated to combine
`
`Ressemann’s collar 2141 with Itou’s suction catheter 2 because “[i]n its fully-
`
`assembled state,” Figure 16A shows only one inclined slope. POR, 14-15. Dr.
`
`Hillstead disagrees and explains that “the tab portion is concave and sits snugly
`
`under the concave structure of the multi-lumen tube,” such that the concave
`
`structure “does pass through the material that is over the top of it.” Ex-2137,
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`420:20-421:25; see also id. at 158:13-22 (“You may not be able to see it [in the
`
`Ressemann figures], but that doesn’t mean that it didn’t have an effect or carry
`
`through ….”).
`
`
`
`5
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`
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`Regardless, as set forth in the Petition, a POSITA would have been
`
`motivated, with a reasonable expectation of success, to incorporate support collar
`
`2141 into the Figure 1 embodiment. Pet., 61, 67-69, citing to claims 37-38, 51-53
`
`and 55-57; Ex-1205 ¶¶182-184, 200-205, 209, 232-236.
`
`PO does not dispute the first motivation to combine collar 2141 with the
`
`Figure 1 embodiment, which is that it would provide a larger area of entry for
`
`devices. PO argues that not all double inclined openings have a larger area of entry.
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`POR, 79. But it is undisputed that collar 2141 does have a larger area than opening
`
`140a, or that a larger opening is beneficial for receiving stent and balloon catheters.
`
`Compare Pet., 68-69 (citing claims 35-39, 51-53, 55-57) with POR, 24-29. As
`
`Petitioner has proposed to modify, collar 2141 would increase the area of entry to
`
`lumen 140 nearly four-fold. Ex-1807 ¶¶109-110.
`
`That Ressemann itself does not explicitly teach this configuration of collar
`
`2141 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
`
`
`
`6
`
`
`
`modifying one reference and combining it with a second reference.”). And that is
`
`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 disputes that the modification would be made to take advantage of collar
`
`2141’s flexibility transition, tab 2141b, because Figure 1’s embodiment already
`
`discloses flexibility transition member 135. POR, 28. But as explained by Mr.
`
`Jones, even though the Figure 1 embodiment had flexibility transition 135, the
`
`presence of Ressemann’s collar would have only further improved the flexibility
`
`transition from stiffer hypotube to flexible evacuation lumen. Ex-1807 ¶¶98-103.
`
`For this additional reason, PO’s arguments fail and a POSITA would have been
`
`motivated to make the proposed modification.1
`
`
`1 Teleflex also argues that a POSITA would not have been motivated to make the
`
`proposed modification because it would obstruct the lumen of the proximal
`
`opening. POR, 30. Given, however, that Ressemann teaches that the diameter of its
`
`collar is preferably 0.0020 inches and that the thickness of the encapsulation
`
`materials is preferably about 0.004 inches (Ex-1208, 24:10-11, 25:8-11), the
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`marginal increase in profile would be outweighed by the resulting improvement in
`
`guiding. Ex-1806 ¶125.
`
`
`
`7
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`
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`PO also argues that a POSITA would have recognized the problems created
`
`by placing Ressemann’s support collar above intermediate shaft 120. POR, 30-32.
`
`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
`
`intermediate shaft would have to be bonded. Id. Both of PO’s arguments fail. In
`
`support of its argument that the proposed modification would create a catch-point,
`
`PO presents the following schematic.
`
`
`
`POR, 31.
`
`PO’s figure, though, does not correctly reflect Ressemann’s relative
`
`dimensions. Ex-1807 ¶¶67-89; Ex-1800, 177:25-178:8. Further, as is standard
`
`practice in the art—and as explicitly taught by Ressemann (Ex-1208, 7:28-39,
`
`24:2-12)—support collar 2141 would be encased in a polymer jacket. Ex-
`
`1807 ¶¶90-91. In so doing, as shown in the below schematic, the proposed
`
`modification would have no catch-points, and the shape of the collar—specifically
`
`
`
`8
`
`
`
`its first and second inclined sidewalls separated by a non-inclined region—would
`
`be retained and would be present in the opening of catheter 2, providing an on-
`
`ramp for entry of a balloon catheter or stent.
`
`
`
`
`
`Ex-1807 ¶¶90-92.
`
`PO is also incorrect to argue that the “convex up” and “convex down”
`
`arrangement would cause the proposed modification to “pop” loose. Indeed,
`
`numerous examples, including those cited on the face of the Teleflex patent (e.g.,
`
`Solar) disclose catheter assemblies with portions having convex up (distal lumen)
`
`and convex down components (pushrod). Ex-1807 ¶¶93-96. Thus, PO is incorrect
`
`to argue that there would not be an expectation of success to make the proposed
`
`
`
`9
`
`
`
`modification. Thus, claim 44 is rendered obvious by Ressemann and the
`
`knowledge of the POSITA.2
`
`Thus, there was a reasonable expectation of success in making the proposed
`
`modification, and claims 42 and 44 are rendered obvious by Ressemann.
`
`IV. GROUND 3: RESSEMANN IN VIEW OF TAKAHASHI RENDERS
`CLAIMS 33 AND 34 OBVIOUS.
`
`PO does not dispute the advantages of removing Ressemann’s sealing
`
`balloons in order to achieve the “about one French” differential between the lumen
`
`of the guide extension catheter and the lumen of the guide catheter. Compare Pet.,
`
`69-74 with POR, 33-38. Instead, PO argues that a POSITA would not be motivated
`
`to remove Ressemann’s balloons because that modification would “eliminate
`
`Ressemann’s primary function of embolic protection.” POR, 34. PO is wrong.
`
`That the proposed modification impacts Ressemann’s embolic protection
`
`function is not determinative of the obviousness inquiry. “[A] skilled artisan cannot
`
`be assumed to ignore” Ressemann “merely because it is primarily directed to a
`
`specific application that is different from the application” of PO’s patent, as “[a]
`
`
`2 Contrary to Teleflex’s argument, Petitioner did not use the district court
`
`infringement contentions as a roadmap. POR, 25. Rather, as explained in the
`
`Petition, Petitioner merely noted that Ressemann has a similarly sized incline that
`
`PO considers sufficient for purposes of infringement. Ex-1205 ¶208.
`
`
`
`10
`
`
`
`reference must be considered for everything that it teaches, not simply the
`
`described invention or a preferred embodiment.” Raytheon Co. v. Sony Corp., 727
`
`Fed. Appx. 662, 667 (Fed. Cir. 2018). In Raytheon, for example, a prior art
`
`reference taught a multi-layer CCD for detecting electromagnetic radiation. Id.,
`
`666. That Petitioner had modified the reference to include silicon, even though the
`
`reference explicitly taught that silicon was not suitable for certain disclosed
`
`applications. Id. Because silicon was suitable for other disclosed applications, the
`
`Board’s obviousness determination was upheld. Id. at 666-667.
`
`Here, PO’s experts do not dispute that Ressemann teaches delivery of a stent
`
`through evacuation lumen 140. Ex-1800, 33:2-16; 34:22-25; 35:16-21; Ex-1801,
`
`33:17-22. Nor is there any dispute that Petitioner’s proposed modifications would
`
`retain Ressemann’s ability to deliver a stent or an angioplasty balloon, as well as
`
`allow assembly 100 to be used with a smaller guide catheter. Pet., 63-67; POR, 33-
`
`38; Ex-1807 ¶¶112-117.
`
`Moreover, PO is mistaken that the modification eliminates embolic
`
`protection. As described by PO’s expert, embolic protection is “something that
`
`prevents debris from flowing downstream.” Ex-1813, 58:15-18. And as also
`
`admitted by PO’s expert, (i) it is possible to “provide embolic protection without
`
`aspiration” and (ii) “there are ways to provide embolic protection without the use
`
`of balloons.” Id., 162:5-11. Before the alleged invention, a POSITA was aware of
`
`
`
`11
`
`
`
`non-occlusive embolic protection devices that did not rely upon aspiration of
`
`emboli. Ex-1811, 1443. These devices were often preferable as some patients were
`
`not able to tolerate occlusion. Modified as Petitioner proposes, Ressemann’s
`
`assembly 100 would not only still be suitable for stent or angioplasty balloon
`
`delivery, but also for delivery of filter-based embolic protection systems. Ex-1806
`
`¶¶109-110; Ex-1807, ¶119.
`
`PO’s remaining arguments are that Petitioner has not accounted for how
`
`modification of Ressemann to remove the sealing balloons might somehow alter
`
`the ID of evacuation lumen 140, or for the modification’s impact on stiffness
`
`transition member 135. POR, 37. Neither argument has any relevance to the
`
`articulated reasons to modify Ressemann, and neither is correct.
`
`First, Ressemann teaches that the sealing balloons 134 and 136 are external
`
`to evacuation lumen 140 (yellow, below). Ex-1208, Figs. 1A-1B; 8:29-40
`
`(explaining that the balloons are “secured to an exterior of the multi-lumen tune
`
`138” at their waist portions, including 134b (circled in purple):
`
`
`
`
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`12
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`
`
`
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`There is no expectation that removing the balloons from the outside of tube
`
`138 would, in and of itself, impact the size of the interior lumens 140 and 142.
`
`Ex-1807 ¶118.
`
`A POSITA, however, had motivation to modify Ressemann so that it could
`
`be used with a smaller guide catheter, for example a 7 French catheter, by
`
`removing the sealing balloons, Pet., 63-67, as well as to increase the size of
`
`evacuation lumen 140.
`
`As Dr. Graham admitted, in the 2005-2006 time frame the concept of
`
`“maximizing the usable real estate” was important, and a POSITA would have
`
`looked to have the largest possible ID of an inner catheter without having to
`
`increase the OD of the outer catheter. Ex-1813, 91:18-92:5. While Ressemann
`
`teaches that lumen 140 is “approximately 0.061 inches,” increasing the lumen size
`
`to 0.065 inches had the benefit of increasing the number of stent catheters that
`
`could be delivered through lumen 140. Ex-1806 ¶114; Ex-1807 ¶116; Ex-1223, 2
`
`(teaching a stent delivery system with a minimum guide catheter diameter of 0.064
`
`inches); Ex-1802, 131-132 (teaching a stent with a crossing profile of 0.064
`
`inches).
`
`A guide catheter with an inner diameter of 0.065 inches meets the limitation
`
`of claim 34 that the inner diameter be > 0.056 inches. Given that the Teleflex
`
`patent teaches that a 7 Fr guide catheter has a lumen of 0.078 inches, Ex-1201,
`
`
`
`13
`
`
`
`3:41-42, this arrangement of catheters also meets the limitation of claim 34 that the
`
`inner lumen of the guide catheter be > 0.070 inches. Claim 34 is obvious.
`
`Furthermore, the proposed modifications result in a differential lumen size
`
`of 0.013 inches, which is 1/3 of a millimeter, or 1 French, Ex-1806 ¶115, which is
`
`the French differential explicitly taught in Takahashi, and which satisfies claim 33.
`
`Pet., 69-70.
`
`Second, Ressemann is explicit that “stiffness transition member 135” is not
`
`within evacuation lumen 140, but within inflation lumen 142, which is a separate
`
`and distinct structure within multi-lumen tube 138. Ex-1208, 11:29-38; Figs. 1A-
`
`1B. It has no bearing on the size of lumen 140.
`
`V. GROUND 4: RESSEMANN IN VIEW OF KATAISHI RENDERS
`CLAIM 44 OBVIOUS.
`
`Like Ressemann, Kataishi teaches an opening with a first inclined sidewall
`
`(161) and a second inclined sidewall (163) separated by a non-inclined region
`
`(164).
`
`Ex-1225; Ex-1806 ¶97
`
`
`
`14
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`
`
`
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`A POSITA was motivated to combine the shape of Kataishi’s distal opening
`
`with Ressemann’s proximal opening. Pet., 74-80. Specifically, adding Kataishi’s
`
`shape to Itou’s proximal opening would have improved loading of interventional
`
`devices. 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, 42. This is belied by explicit teachings in
`
`Ressemann— and in a patent by their own expert, 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,
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`and to facilitate smoother passage of other therapeutic devices
`
`through the evacuation lumen 140 of the evacuation head 132. The
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`larger area of the angled open ends also allows for larger deformable
`
`particulate matter to pass through the lumen more smoothly.
`
`Ex-1208, 6:52-60 (emphasis added).
`
`
`
`15
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`
`
`
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`Ex-1208, Fig. 1A; and 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-1323, 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,
`
`such as a balloon-expandable stent. Id.; see also Ex-1208, Figs. 6E, 6G, 13:57:14-
`
`14:26. Thus, Kataishi’s teaching that the shape of its distal tip improves that
`
`catheter’s ability to suction thrombus would be understood by a POSITA to also
`
`apply to the proximal opening of a catheter such as Ressemann. Ex-1807 ¶¶133-
`
`142, 144; Ex-1806 ¶¶138-141; Ex-1205 ¶¶249-256. The shape of Kataishi’s
`
`opening increases the area of the proximal opening as compared to Ressemann’s
`
`single incline opening. Ex-1807 ¶145.
`
`
`
`16
`
`
`
`
`Id. (Schematic illustrating relative area of Ressemann’s embodiment 100 proximal
`
`opening (Ex-1208, Figs. 1A, 1C) versus Kataishi’s proximal opening (Ex-1225,
`
`Fig. 12)). And an increase in the area of opening makes it easier to introduce a
`
`stent or balloon catheter. Ex-1205 ¶¶249-256; Ex-1242 ¶¶104-112; Ex-1807 ¶¶135-
`
`138; Ex-1806 ¶¶138-141.
`
`Medtronic also presented evidence that Kataishi’s shape improves the ability
`
`of the catheter to “advance to distal locations,” Pet., 79, which means that it
`
`improves the catheter’s crossability. Ex-1225, Abstract; ¶0026; Ex-1205 ¶¶254-
`
`255. In co-pending petitions, PO incorrectly argues that adding Kataishi’s shape to
`
`Ressemann’s proximal opening would not improve crossability. IPR2020-00132,
`
`Paper 44, 51. As a threshold matter Ressemann teaches that both the proximal and
`
`distal ends of evacuation lumen 140 assist in ensuring “smoother passage of the
`
`evacuation sheath assembly 100 through a guide catheter.” Ex-1208, 6:52-57.
`
`
`
`17
`
`
`
`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.” IPR2020-00132, Paper 44 at 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-1255, 6, 8. 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 Ressemann’s proximal opening to include the
`
`shape of Kataishi’s distal tip was an obvious modification. Ex-1806 ¶¶138-141;
`
`Ex-1205 ¶¶249-256.
`
`VI. PO ASSERTS SECONDARY CONSIDERATIONS BASED UPON
`SOMETHING IT DID NOT INVENT—A RAPID-EXCHANGE
`VERSION OF A GUIDE EXTENSION CATHETER.
`
`The earliest rapid exchange (“Rx”) guide extension catheter (“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 GEC. Ressemann and Itou also
`
`have a side opening. 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 claims to have conceived of the idea
`
`
`
`18
`
`
`
`claimed in the Teleflex patents. Compare Ex-1755 ¶¶27-38 with IPR2020-00126,
`
`Ex-2118 ¶¶5-6.
`
`Nevertheless, PO bases nearly its entire secondary considerations case on
`
`these features. POR, 73-80 (arguing nexus for claim 33). PO calls out claim 33,
`
`which recites a reinforced section with a lumen “having a uniform inner diameter
`
`that is about one French smaller than an inner diameter of the continuous lumen of
`
`the guide catheter.” Id., 75. Claim 33 depends from claim 25, which recites a
`
`method for forming a device with a side opening adapted to receive IVCDs. In its
`
`presentation of alleged secondary considerations, PO focuses entirely on
`
`functionality associated with features set forth in claim 25, not claim 33. See id.,
`
`52-65, 73-80.
`
`PO makes the fundamental error of confusing commercialization with
`
`invention. Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282-83 (1976) (secondary
`
`considerations, “without invention, will not make patentability”). It does not matter
`
`if PO was first to market when the combination of features for which it claims
`
`secondary considerations were in the prior art. In re Kao, 639 F.3d 1057, 1068
`
`(Fed. Cir. 2011) (“Where the offered secondary consideration[s] actually results
`
`from something other than what is both claimed and novel in the claim there is no
`
`nexus to the merits of the claimed invention.”). Ressemann discloses all elements
`
`of claim 25, and the only potential obviousness issue is modification of Ressemann
`
`
`
`19
`
`
`
`to achieve a differential between the inner diameter of evacuation lumen 140 and
`
`the inner diameter of a guide catheter that was about one French. Ex-1205 ¶¶167-
`
`80, 237-47. On this record, 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.”).
`
` Mother-in-Child and Rx Devices were Well Known, and so was
`the Combination.
`
`Rx technology was developed in the 1980s for balloon catheters. Ex-2138
`
`¶71; Ex-2145 ¶82; Ex-1762, 39:1-22; Ex-1114, 111:13-17. There was a trend in the
`
`industry toward full adoption through the 1990s and early 2000s. Ex-1800, 26:10-
`
`27:8; Ex-1817, 25:20-26:9, 37:8-38:6. Full-length mother-in-child was also known
`
`to provide guide extension and additional backup support. Ex-1800, 16:22-17:16;
`
`Ex-1762, 36:3-10, 194:4-16; Ex-1817, 25:20-26:9; IPR2020-00126, Ex-2123 ¶20.
`
`As stated by inventor Root, the alleged invention of the Teleflex patents was to
`
`make an Rx version of mother-in-child catheter. Ex-1762, 39:19-21, 67:23-68:1;
`
`IPR2020-00126, Ex-2003; Ex-1114, 61:24-62:9, 77:9-16, 121:12-122:1. Dr.
`
`Thompson concedes that the only structures you need to apply the benefits of
`
`modern GEC catheters are Rx, a side opening, and a lumen relatively close to the
`
`size of the GC. Ex-1817, 63:10-64:8; Ex-2215 ¶22. Kontos, Itou, and Ressemann
`
`
`
`20
`
`
`
`are Rx, close in size to the GEC, provide backup support, and the latter two have
`
`side openings. § VI, supra.
`
`
`
`PO’s Secondary Consideration Evidence All Relates to Prior Art
`Features and Functionality.
`
`“If the feature that creates the commercial success was known in the prior
`
`art, the success is not pertinent.” Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299,
`
`1312 (Fed. Cir. 2006). PO’s cited marketing documents prominently emphasize
`
`prior art functionality of “rapid exchange convenience” and “added backup
`
`support.” POR, 76-78 (highlighting Ex-2155, -2158, -2161, -2164).
`
`
`
`PO’s “Copying” Allegations are Without Merit.
`
`Unlike its other secondary considerations evidence, PO bases its “copying”
`
`allegations on claims 33 and 44. PO cannot establish a nexus between its
`
`secondary considerations evidence and claim 33, and its “copying” evidence with
`
`respect to claim 44 is unfounded.
`
`1.
`
`Neither GuideLiner nor Telescope practice Claim 33.
`
`Claim 33 requires the subject catheter to have a “reinforced section
`
`including a lumen” with a “uniform inner diameter that is about one French
`
`smaller than the cross-sectional inner diameter of the lumen of the guide catheter.”
`
`The difference between the inner diameters of GuideLiner and Telescope and the
`
`corresponding GC used with both is more than one French—.014 inches.
`
`
`
`21
`
`
`
` _!
`_-.- il-
`
`GuideLiner“ VSGEC‘
`
`0.051
`
`0063
`
`6F20.066
`
`..
`
`l_ 1,,
`
`25
`
`Telescope"GEC
`
`0.056
`
`<30idel.iner""l.'.(SEC1 0.056
`
`a
`Guidezillamll GEC’
`0.057
`
`.067
`
`.067
`
`6F20.070
`
`0 $20070
`
`0.007
`
`6 r 2 0.070
`
`- Telescope”c£c
`1
`GuldeUner'"V3 GEC‘
`
`0.062
`0.062
`
`0.075
`0.015
`
`7 F 2 0.070
`7 F 2 0.073
`
`i 7
`
`Guldezilla‘“ ll GECz
`
`0.06 5
`
`0.073
`
`7 F 2 0.078
`
`5
`
`5
`
`25
`
`25
`25
`
`25
`
`A
`
`17
`
`NIA. metal mum
`
`a
`17
`
`N/A. metal collar
`
`150
`
`150
`
`150
`150
`
`150
`
`Ex-1282, 1158.
`
`ii.
`
`PO’s “copying” allegations against Boston Scientific and QX
`Medical concern prior art features.
`
`Like Itou and Ressemann, Guidezilla3 and The Boosting Catheter are Rx
`
`devices configured to deliver a wide variety of IVCDs and provide increased back
`
`3 PO has not submitted the Boston Scientific license or provided any context
`
`surrounding it. 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
`
`terminated their litigation in August 2014 (Ex-2044 1134), less than three months
`
`after Boston Scientific filed four IPR petitions against alleged GuideLiner patents.
`
`See IPR2014-00759, -760, —762, -763.
`
`22
`
`
`
`up support when extended partially past the end of a GC. Compare Ex-2046,
`
`¶¶70-71 and Ex-2056, ¶76, with Ex-1207, 4:27-32, Figs. 3-5; Ex-1208, Abstract,
`
`6:18-24, 12:9-14:39, Figs. 6A-F. Like Itou and Ressemann, Guidezilla also had a
`
`side opening. Id. PO presents no analysis—and does not argue—that Guidezilla or
`
`The Boosting Catheter “copied” claim 44, which purportedly covers the “half-
`
`pipe” side openin
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