Paper No. __________
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`
`
`
`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: IPR2020-00134
`U.S. Patent No. RE45,760
`______________________________
`
`PETITIONER’S REPLY
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`

`

`TABLE OF CONTENTS
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`Page
`TABLE OF CONTENTS ............................................................................................ i
`
`TABLE OF AUTHORITIES .................................................................................... iii
`
`I.
`
`INTRODUCTION ........................................................................................... 1
`
`II. GROUNDS 1-3: PO DOES NOT CHALLENGE ITOU’S
`DISCLOSURE, WHICH ANTICIPATES OR RENDERS OBVIOUS
`CLAIMS 48 AND 51-53. ................................................................................ 2
`
`III. GROUND 4: CLAIMS 48 AND 51-53 ARE RENDERED OBVIOUS
`BY RESSEMANN IN VIEW OF TAKAHASHI. ........................................... 2
`
`A.
`
`Ressemann discloses a “tubular structure defining a lumen
`coaxial and in fluid communication with the lumen of the guide
`catheter.” ................................................................................................ 2
`
`1.
`
`2.
`
`“Coaxial” means “the axis of the lumen of the guide extension
`catheter is aligned in the same direction as the axis of lumen of
`the guide catheter.” ...................................................................... 2
`
`Ressemann’s multi-lumen tube 138 defines evacuation lumen
`140, which is coaxial and in fluid communication with the
`lumen of guiding catheter 160. ................................................... 9
`
`B.
`
`C.
`
`Ressemann in view of Takahashi renders obvious claims 48 and
`51-53. ................................................................................................... 11
`
`PO does not separately challenge that claim 52 is obvious in
`view of Ressemann and the knowledge of a POSITA. ....................... 15
`
`IV.
`
`PO ASSERTS SECONDARY CONSIDERATIONS BASED UPON
`SOMETHING IT DID NOT INVENT—A RAPID-EXCHANGE
`VERSION OF A GUIDE EXTENSION CATHETER. ................................. 16
`
`A. Mother-in-child and Rx devices were well known, and so was
`the combination. .................................................................................. 17
`
`B.
`
`PO’s secondary considerations evidence all relates to prior art
`features and functionality. ................................................................... 18
`
`
`
`i
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`

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`V.
`V.
`
`CONCLUSION .............................................................................................. 23
`CONCLUSION .............................................................................................. 23
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`
`
`
`
`
`
`ii
`ii
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`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`
`Amazon.com, Inc. v. Barnesandnoble.com, Inc.,
`239 F.3d 1343 (Fed. Cir. 2001) .......................................................................... 18
`
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) .............................................................. 16, 19, 20
`
`Johns Hopkins Univ. v. Datascope Corp.,
`543 F.3d 1342 (Fed. Cir. 2008) .......................................................................... 20
`
`Ormco Corp. v. Align Tech., Inc.,
`463 F.3d 1299 (2006) .......................................................................................... 18
`
`Raytheon Co. v. Sony Corp.,
`727 F. App’x 662 (Fed. Cir. 2018) ..................................................................... 12
`
`Sakraida v. Ag Pro, Inc.,
`425 U.S. 273 (1976) ............................................................................................ 16
`
`W.M. Wrigley Jr. Co. v. Cadbury Adams USA LLC,
`683 F.3d 1356 (Fed. Cir. 2012) .......................................................................... 19
`
`ZUP, LLC v. Nash Mfg., Inc.,
`896 F.3d 1365 (Fed. Cir. 2018) .......................................................................... 17
`
`
`
`
`
`iii
`
`

`

`I.
`
`INTRODUCTION
`
`The evidence in the Petition establishes that Itou (Grounds 1-3) and
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`Ressemann (Ground 4) anticipate or render obvious claims 48 and 51-53. PO does
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`not dispute any of the evidence cited in Grounds 1-3, focusing its substantive
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`response solely on Ground 4.
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`PO also cannot dispute that Ressemann discloses a guide extension catheter
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`(“GEC”) that “is passed through the lumen of a guide catheter, advanced beyond
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`the distal end of the guide catheter, and inserted into a branch artery of the aorta,”
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`or that Ressemann’s assembly 100 “facilitate[s] delivery of stents and balloon
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`catheters.” Compare Paper 41 (“POR”), 4, with Ex-1608, Figs. 6A-6I. Instead, it
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`focuses on two claimed features, each of which is unremarkable and well known in
`
`the art.
`
`First, PO argues that Ressemann does not disclose a guide extension catheter
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`with a lumen “coaxial” to the guide catheter lumen, relying on an understanding
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`that would require a perfect overlap in the axes. PO’s own witness testimony and
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`documents, however, confirm the accuracy of Medtronic’s position that coaxial
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`means “the axis of the lumen of the guide extension catheter is aligned in the same
`
`direction as the axis of lumen of the guide catheter.”
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`Second, PO argues that a POSITA would not be motivated to modify
`
`Ressemann to achieve a “one French size” differential with the guide catheter. For
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`
`
`1
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`

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`the reasons set forth in the Petition and herein, PO is wrong. Claims 48 and 51-53
`
`are obvious.
`
`II. GROUNDS 1-3: PO DOES NOT CHALLENGE ITOU’S
`DISCLOSURE, WHICH ANTICIPATES OR RENDERS OBVIOUS
`CLAIMS 48 AND 51-53.
`
`PO argues that Itou is not prior art. POR, 1. But PO has not established that
`
`its claims were conceived and reduced to practice prior to Itou. Paper 75.
`
`Accordingly, each claim addressed in Grounds 1-3 is anticipated or obvious based
`
`on the evidence Medtronic cites in its Petition.
`
`III. GROUND 4: CLAIMS 48 AND 51-53 ARE RENDERED OBVIOUS BY
`RESSEMANN IN VIEW OF TAKAHASHI.
`
`A. Ressemann discloses a “tubular structure defining a lumen
`coaxial and in fluid communication with the lumen of the guide
`catheter.”
`
`1.
`
`“Coaxial” means “the axis of the lumen of the guide
`extension catheter is aligned in the same direction as the
`axis of lumen of the guide catheter.”
`
`PO has twisted the meaning of coaxial throughout these proceedings. In the
`
`POR, PO took the position that coaxial means the lumens must be perfectly
`
`concentric, such that any deviation off axis by the extension catheter means the
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`claim element is not met. POR, 11-13. But PO’s lead expert later admitted, twice,
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`
`
`2
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`

`

`that it may be off axis the whole time and still be coaxial.1 Ex-1764, 91:10-23,
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`94:11-19. Clearly the term “coaxial” in this art does not mean “sharing the same
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`axis” as it might in other arts.
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`The claims recite a “coaxial” relationship between the lumens of the guide
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`and guide extension catheters, where the former is configured to be placed in the
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`coronary artery ostium, and the latter is configured to be extended through the
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`guide catheter and into the coronary vasculature. Ex-1601, 13:36-14:7. This
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`coaxial relationship allows for the claimed capability to receive one or more stents
`
`or balloon catheters, which does not require a concentric relationship. Id., 13:67-
`
`14:1.
`
`Similarly, the patent specification explains that a “coaxial arrangement” is
`
`one in which an extension catheter has been inserted into a guide catheter and the
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`two are in line with the coronary artery.
`
`
`1 The Board also relied on Teleflex’s interpretation of coaxial, now withdrawn, to
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`deny institution of another petition. IPR2020-00133, Paper 20, 14-15.
`
`
`
`3
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`

`

`
`
`Figure 8, for example, discloses extension catheter (12) inserted through
`
`guide catheter (56), with each catheter in line with the ostium of the coronary
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`artery (60). Ex-1601, 8:10-16, Fig. 8. The specification places no limitations on the
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`size of guide catheter or the amount of radial displacement available to the coaxial
`
`guide catheter.
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`The specification is consistent with the general use of the word “coaxial” in
`
`this particular art. As Dr. Brecker testified:
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`From the very first point that I ever put a guide catheter into a coronary
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`artery, there is a need for the guide catheter to be in line with the coronary
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`artery, and cardiologists refer to that as being coaxial. They do not need,
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`and in fact, almost never will share a center line.
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`Ex-2116, 323:25-324:11; Ex-1806 ¶16; and see ¶¶17-26. The same is true of a
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`“coaxial guide catheter.
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`
`
`4
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`

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`This understanding is reflected in Patent Owner’s own documents, which
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`consistently refer to a “coaxial” alignment in reference to a catheter-in-catheter
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`arrangement that is in line with the coronary ostia.
`
`Ex-1812, 24183 (top); Ex-1815, 131005 (lower). In this art, the term clearly refers
`
`to directional alignment, not mathematical precision or concentricity, which is
`
`impossible.
`
`Long before the current dispute with Medtronic, inventor Root agreed,
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`testifying that a coaxial guide catheter is “a tube-within-a-tube…for delivering
`
`interventional cardiology devices into the vasculature.” Ex-1715, 37:10-17; see
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`
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`5
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`

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`Ex-1714, 86:1-87:7
`
`)
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`
`
`
`
`
`
` Ex-1714, 66:22-67:2. In this
`
`matter, Root initially testified that simply a showing of putting an extension
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`catheter into a guide catheter is sufficient to establish that the two are coaxial.
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`Ex-1762, 173:10-25. And while he attempted to backtrack adding the gloss that
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`coaxial means a “shared” axis (contradicting his testimony from not one, but two
`
`prior depositions), he also admitted that “nothing is perfectly concentric,” and “if
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`it’s a circle in a circle, that’s coaxial.” Id., 174:13-175:6, 176:11-19.
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`The fact that “coaxial” cannot be construed to mean a mathematically
`
`perfect overlap is further supported by PO’s expert, Mr. Keith, who testified that
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`“if you’ve got a tubular structure inside another tubular structure, that is a coaxial
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`arrangement,” Ex-1764, 90:20-91:2, and agreed that “coaxial” does not require
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`perfect concentricity at any point. Id., 91:3-9; see Ex-1805, 119:22-120:12
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`(explaining that catheter engineers and designers know that catheter arrangements
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`that are tubes inside tubes are…not magically automatically in line (sic) be their
`
`axis, but they are still referred to as coaxial structures and arrangements if they are
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`relatively close). For example, in describing the catheter arrangement depicted
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`
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`6
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`

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`below, Keith explained that the catheters are not always in the same arrangement
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`and are “free to migrate a little bit across the cross section,” but are still referred to
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`as “coaxial.” Id., 120:13-121:1. Keith testified that testified that a 4-in-6 French,
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`and a 5-in-7 French (illustrated below) are both coaxial. Ex-1800, 23:19-24:1;
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`Ex-1805, 119:4-7, 119:12-121:1.
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`
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`Ultimately, Keith provided a definition that coaxial means, “essentially a
`
`tube-in-a-tube arrangement that is relatively close fitting.” Ex-1764, 98:18-21. But
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`he could not say what relatively close fitting means. Id., 98:22-99:4. Based on both
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`his testimony and that of PO’s cardiologist, Graham, it cannot require a 1 French
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`differential. Ex-1801, 37:22-38:2. While this definition is an improvement over
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`
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`7
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`

`

`PO’s original position, it still focuses on tubes, whereas the claims recite coaxial
`
`lumens.2
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`Following Keith’s testimony, it is certain that the lumens may be off-axis,
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`but unclear by how much. At a minimum any definition must cover the preferred
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`embodiment of a 5-in-6 French catheter, as well as the admitted coaxial nature of a
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`4-in-6 French arrangement. These arrangements are shown schematically below,
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`with 0.005 and 0.018 inches of annular gap space respectively.
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`
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`
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`2 On redirect, Keith construed his construction, stating the tubes must have “radial
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`symmetry.” Ex-1764, 101:10-24. This new theory has nothing to do with defining
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`coaxial lumens.
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`
`
`8
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`

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`Ex-1601, 3:42-44 (teaching a 6 French catheter with an inner diameter (“ID”) of
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`0.070 inches); Ex-1806 ¶23 (explaining that 5 and 4 French catheters have ODs of
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`0.065 and 0.052 inches respectively).
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`These examples could be taken to extremes like a 4-in-8 French arrangement
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`and there is nothing in the specification or elsewhere that suggests that is no longer
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`coaxial. As used in the Teleflex patents, and the art in general, coaxial simply refers
`
`to the alignment of the lumens. Thus, coaxial means “the axis of the lumen of the
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`guide extension catheter is aligned in the same direction as the axis of lumen of the
`
`guide catheter.” Any attempt to require further precision would render the claim
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`indefinite.
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`2.
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`Ressemann’s multi-lumen tube 138 defines evacuation
`lumen 140, which is coaxial and in fluid communication
`with the lumen of guiding catheter 160.
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`As set forth in the Petition, Ressemann meets this claim limitation. Pet.,
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`61-63. Lumen 140 is defined by tube 138, which is part of assembly 100’s
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`evacuation head 132. Ex-1608, 6:35-47.
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`
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`
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`
`
`
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`9
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`

`

`Id., Figs. 1A-B.
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`Ressemann teaches that assembly 100 is advanced through guiding catheter
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`160 until the evacuation head’s distal end is within the coronary vessel, while its
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`proximal end remains in catheter 160. Id., 12:9-30.
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`
`
`
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`Id., Fig. 6B (annotations added).
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`As shown in Fig. 6B, the axis of lumen 140 within evacuation head 132
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`(red) is necessarily aligned in the same direction as the axis of the lumen of the
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`guiding catheter 160 (blue). Ex-1806 ¶101; see Ex-2116, 320:20-321:3 (Dr.
`
`Brecker testifying that he has used coaxial dual lumen catheters).
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`Moreover, Ressemann teaches an 8 French guide catheter has an ID of 0.090
`
`inches, and that the outer diameter (“OD”) of the tubular structure within which
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`lumen 140 sits is 0.076 inches, which leaves an annular gap of 0.014 inches. Ex-
`
`
`
`10
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`

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`1608, 10:14-29. As illustrated below, this results in a closer fitting within
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`Ressemann than the admitted co-axial relationship between a 4-in-6 French
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`catheter.
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`
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`Ex-1806 ¶¶103-104, and see generally ¶¶100-105.
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`Lumen 140 is therefore “coaxial” to the lumen of guiding catheter 160, and
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`is in fluid communication with the same. Pet., 61-63; Ex-1608, 9:30-36.
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`B. Ressemann in view of Takahashi renders obvious claims 48 and
`51-53.
`
`PO does not dispute the advantages of removing Ressemann’s sealing
`
`balloons in order to achieve the not-more-than-one-French differential. Compare
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`Pet., 63-67 with POR 18-21. Instead, PO argues that a POSITA would not be
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`motivated to remove Ressemann’s balloons because that modification would
`
`
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`11
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`

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`“eliminate Ressemann’s primary function of embolic protection.” POR, 13. PO is
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`wrong.
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`That the proposed modification impacts Ressemann’s embolic protection
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`function is not determinative of the obviousness inquiry. A “skilled artisan cannot
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`be assumed to ignore” Ressemann “merely because it is primarily directed to a
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`specific application that is different from the application” of PO’s patent, as “a
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`reference must be considered for everything that it teaches, not simply the
`
`described invention or a preferred embodiment.” Raytheon Co. v. Sony Corp., 727
`
`F. App’x 662, 667 (Fed. Cir. 2018). In Raytheon, for example, a prior art reference
`
`taught “a multi-layer CCD for detecting electromagnetic radiation.” Id. at 666.
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`Petitioner modified the reference to include silicon, even though the reference
`
`explicitly taught that silicon was not suitable for certain disclosed applications.
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`Because silicon was suitable for other disclosed applications, the Board’s
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`obviousness determination was upheld. Id. at 667-68.
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`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,
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`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 13-
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`21; Ex-1807 ¶¶112-117.
`
`
`
`12
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`

`

`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
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`non-occlusive embolic protection devices that did not rely upon aspiration of
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`emboli. Ex-1811, 1443. These devices were often preferable as some patients were
`
`not able to tolerate occlusion. Modified as Petitioner proposes, Ressemann’s
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`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
`
`¶¶107-110; Ex-1807 ¶119.
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`PO’s remaining arguments are that modification of Ressemann to remove
`
`the sealing balloons might somehow alter the ID of evacuation lumen 140, and that
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`the modifications do not account for “‘stiffness transition member 135’ that sits in
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`a separate lumen location inside the evacuation lumen 140 and that extends all the
`
`way to the tip of the evacuation sheath.” POR, 19. Neither argument has any
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`relevance to the articulated reasons to modify Ressemann, and neither is correct.
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`First, Ressemann teaches that the sealing balloons 134 and 136 are external
`
`to evacuation lumen 140 (yellow, below). Ex-1608, 8:29-40, Figs. 1A-B
`
`
`
`13
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`

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`(explaining that the balloons are “secured to an exterior of the multi-lumen tune
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`138” at their waist portions, including 134b (circled in purple).
`
`
`
`
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`There is no expectation that removing the balloons from the outside of tube
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`138 would, in and of itself, impact the size of the interior lumens 140 and 142. Ex-
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`1807 ¶118; Ex-1806 ¶¶111.
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`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
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`removing the sealing balloons, Pet., 63-67, as well as to increase the size of
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`evacuation lumen 140. As Dr. Graham admitted, in the 2005-2006 time frame the
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`concept of “maximizing the usable real estate” was important, and a POSITA
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`would have looked to have the largest possible ID of an inner catheter without
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`having to increase the OD of the outer catheter. Ex-1813, 91:18-92:5. While
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`Ressemann teaches that lumen 140 is “approximately 0.061 inches,” increasing the
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`lumen size to 0.065 inches had the benefit of increasing the number of stent
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`catheters that could be delivered through lumen 140. Ex-1806 ¶¶112-114; Ex-1807
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`
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`14
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`

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`¶116; Ex-1623, 2 (teaching a stent delivery system with a minimum guide catheter
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`diameter of 0.064 inches); Ex-1802, 131-32 (teaching a stent with a crossing
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`profile of 0.064 inches). Given that the Teleflex patent teaches that a 7 Fr guide
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`catheter has a lumen of 0.078 inches (Ex-1601, 3:41-42), the modifications
`
`proposed would result in a differential lumen size of 0.013 inches, which is 1/3 of a
`
`millimeter, or 1 French. Ex-1806 ¶115. This 1 French differential is also explicitly
`
`taught in Takahashi. Pet., 66.
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`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-1608, 11:29-38, Figs. 1A-B.
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`It has no bearing on the size of lumen 140.
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`Claims 48, 51 and 53 are obvious.
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`C.
`
`PO does not separately challenge that claim 52 is obvious in view
`of Ressemann and the knowledge of a POSITA.
`
`Claim 52 depends from claim 1, adding the limitation that the guide
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`extension catheter include “a longitudinal length of the reinforced braid or coil”
`
`that is “between 20-30 cm.” Aside from its challenges to the Ressemann disclosure
`
`discussed herein, PO has not challenged that Ressemann in view of the common
`
`knowledge of a POSITA renders claim 52 obvious. POR, 21. Claim 52 is obvious.
`
`
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`15
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`

`

`IV. PO ASSERTS SECONDARY CONSIDERATIONS BASED UPON
`SOMETHING IT DID NOT INVENT—A RAPID-EXCHANGE
`VERSION OF A GUIDE EXTENSION CATHETER.
`
`The earliest 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. Ressemann and Itou also have a side opening. These devices and device
`
`features—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. Compare Ex-1755 ¶¶28-38 with Ex-2118 ¶5.
`
`Nevertheless, PO bases its entire secondary considerations case on these
`
`features alone. POR, 43-45. PO makes the fundamental error of confusing
`
`commercialization with invention. Sakraida v. Ag Pro, Inc., 425 U.S. 273, 278
`
`(1976) (secondary considerations, “without invention, will not make
`
`patentability”). It does not matter if PO was first to market when the combination
`
`of features it relies upon were in the prior art. In re Kao, 639 F.3d 1057, 1068−69
`
`(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.”).
`
`
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`16
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`

`

`In this IPR, PO calls out claims 48, 51, 53 which recite a side opening
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`adapted to receive IVCDs. Itou has that, and the only potential obviousness issue is
`
`using Ressemann’s teaching to actually do it. But PO does not challenge
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`Petitioner’s Itou-based grounds. The only obviousness issues raised by PO are
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`whether (1) Ressemann discloses a GEC with a lumen “coaxial” to the guide
`
`catheter lumen, and (2) a POSITA would not be motivated to modify Ressemann to
`
`achieve a “one French size” differential with the GC. On this record, PO cannot
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`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. Mother-in-child and Rx devices were well known, and so was the
`combination.
`
`Rx technology, as opposed to OTW, was developed in the 1980s for balloon
`
`catheters. Ex-2138 ¶71 (“rapid exchange functionality existed for almost two
`
`decades before GuideLiner.”); Ex-2145 ¶82; Ex-1762, 39; Ex-1714, 111:13-17.
`
`And 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
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`OTW mother-in-child was known to provide guide extension and additional
`
`backup support. Ex-1800, 16:22-17:1; Ex-1762, 194:4-16; Ex-1817, 25:20-26:9;
`
`Ex-1762, 36:3-10; Ex-2123 ¶20. As stated by inventor Root in his earliest notes
`
`and throughout his testimony, the alleged invention was to make an Rx version of a
`
`
`
`17
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`

`

`mother-in-child catheter. Ex-1762, 39:19-21, 67:23-68:1; Ex-2003; Ex-1714 at
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`61:24-62:22, 77:9-15, 121:12-122:1. Dr. Thompson concedes that the only
`
`structure you need to enjoy the benefits of modern GEC catheters is Rx, a side
`
`opening, and a lumen relatively close to the size of the GC. Ex-1817, 63:10-64:8;
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`Ex-2215 ¶22. Dr. Azzalini concedes that all of the drawbacks he lists of mother-in-
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`child are alleviated by the change to Rx, and all of the relevant benefits he cites for
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`GECs flow from the change from mother-in-child to Rx. Ex-1762, 23:15-26:22.
`
`But once again, Kontos, Itou and Ressemann are Rx, close in size to the GC,
`
`provide back support, and the latter two have side openings. Supra § III.
`
`B.
`
`PO’s secondary considerations 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 (2006) PO’s cited marketing documents prominently emphasize prior art
`
`functionality of “rapid exchange convenience” and “added backup support.” POR,
`
`46-48 (highlighting Ex-2155, Ex-2158, Ex-2161, Ex-2164).
`
`PO’s alleged copying evidence likewise focuses on prior art features and
`
`functionality. Copying is not relevant to prove nonobviousness where, as here, the
`
`feature that is copied is present 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
`
`
`
`18
`
`

`

`of the claimed invention, in view of the substantial question of validity raised by
`
`the prior art references.”); W.M. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683
`
`F.3d 1356, 1364 (Fed. Cir. 2012); see also In re Kao, 639 F.3d at 1068 (“Where the
`
`offered secondary consideration 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.”).
`
`PO compares competing products to various versions of GuideLiner,
`
`ignoring the fact that the features for which is claims nexus (and copying) are
`
`clearly disclosed in the prior art. Like Itou and Ressemann, Guidezilla3 and The
`
`Boosting Catheter are Rx devices configured to deliver a wide variety of IVCDs
`
`and provide increased back up support when extended partially past the end of a
`
`
`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 ¶34), less than three months
`
`after Boston Scientific filed four IPR petitions. See IPR2014-00759, -760, -762,
`
`-763.
`
`
`
`19
`
`

`

`GC. Compare Ex-2046 ¶¶70-71 and Ex-2056 ¶¶73-74 with Ex-1607, 4:27-32,
`
`Figs. 3-5; Ex-1808 Abstract, 6:18-24, 12:9-14:39, Figs. 6A-6F. Like Itou and
`
`Ressemann, Guidezilla also had a side opening. Id.
`
`Telescope also practices the prior art. 4 Compare Ex-2071, 10, 35 with
`
`Ex-1607, Figs. 3-5, 4:27-32; Ex-1608, 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.
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`POR, 33-41. None of the claims for which PO claims nexus in this IPR pertain to
`
`its “half-pipe.”5 See IPR2020-00126, Ex-2138 ¶147.
`
`
`4 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-1677, 22:3-20.
`
`5 Telescope is not a “copy” of GuideLiner. Ex-1830 ¶3-27. In addition to the
`
`differences acknowledged by PO (POR, 40),
`
`
`
` Ex-
`
`1821, 233:10-23, 236:16-21 (
`
`). Telescope features SmoothPass Technology (Ex-2071, 15-27) for
`
`improved device deliverability,
`
`
`
`20
`
`
`
`
`
`

`

`Indeed, neither Telescope (nor GuideLiner) practice the claims for which PO
`
`claims nexus. Claims 48, 51, and 53 of the ’760 patent require the subject catheter
`
`to have a “tubular structure defining a lumen” with a “uniform cross-sectional
`
`inner diameter that is not more than one French size smaller than the cross-
`
`sectional inner diameter of the lumen of the guide catheter.”
`
`
`
`
`
`
`
` 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
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`Catheter infringes due to the 0.0131 difference); see also Ex-1844, 27:3-9 (Judge
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`Schiltz noting that PO’s attorneys “stood before [him] in QX Medical and told
`
`[him] one French meant 0.00131 inches”).
`
`
`
`29; Ex-1823, 11.
`
`
`
`21
`
` Ex-1822, 28-
`
`

`

`But the difference for both GuideLiner and Telescope is 0.014 inches.
`
`GuideLiner" VSGEC‘
`
`0.051
`
`0.063
`
`6F20.066
`
`Telescope" csc
`
`0.056
`
`Gddetiner"vse£c* 0.056
`
`.067
`
`.007
`
`6F20.070
`
`6F20.070
`
`0
`
`Guidezillamll GEC’
`
`0.057
`
`0.067
`
`0 F 2 0.070
`
`- Telescope”G£C
`7
`GuideLinen"V5 GEC‘
`
`0.062
`0.062
`
`0.075
`0.015
`
`7 F 2 0.078
`7 F20.078
`
`7
`
`Guidezflla'" II (5E8
`
`0.06;
`
`0.07}
`
`7 F 2 0.078
`
`5
`
`25
`
`25
`25
`
`25
`
`4
`
`n
`
`N/A, metal c0110!
`
`a
`n
`
`N/A. nwtal collm
`
`250
`
`150
`
`150
`
`150
`150
`
`150
`
`
`
`l
`
`Ex-1682 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
`
`your creativity [that 1 French means more than 0.0131 inches]. You’re going to be
`
`walking uphill for me on that argument”).
`
`PO’s “copying” arguments also ignore other important differences between
`
`GuideLiner and Telescope. Ex—1830 113-27. 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, 41.
`
`“Copying requires the replication of a specific product,” Iron Grip, 392 F.3d at
`
`1325, and these differences are not “small.” Ex-1830 1116-26. When deposed in the
`
`District Court, MS- Welch—
`
`— Ex-1821, 18, 53-54; see also Ex-2071, 7.—
`
`22
`
`

`

` Ex-1822, 13; see also Ex-1823, 18. GEC
`
`coating is clinically relevant. Ex-1817, 65:16-66:10.
`
`
`
`
`
` Ex-1824, 4:22-5:10. These product differences confirm a
`
`
`
`lack of copying.
`
`V. CONCLUSION
`
`For the foregoing reasons, as well as those set forth in the Petition, claims 48
`
`and 51-53 of the ’760 patent are anticipated and/or obvious.
`
`
`
`
`
`Date: December 21, 2020
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`
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`
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`RESPECTFULLY SUBMITTED,
`
`ROBINS KAPLAN LLP
`
`
`
`/ Cyrus A. Morton /
`Cyrus A. Morton
`800 LaSalle Avenue, Suite 2800
`Minneapolis, MN 55402
`(612) 349-8500
`Attorney for Petitioner
`
`
`
`23
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`WORD COUNT CERTIFICATION
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`I hereby certify that this Reply complies with the word count limit, and
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`contains 4,061 words. I further certify that, in preparation of this Reply, I used
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`Microsoft Word, Version 2016, and that this word processing program has been
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`applied specifically to include all text, including headings, footnotes, and
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`quotations in the following word count.
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`
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`Dated: December 21, 2020
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`
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`
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`
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`
`
`
`/ Cyrus A. Morton /
`Cyrus A. Morton
`Registration No. 44,954
`Attorney for Petitioner
`
`
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`24
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`CERTIFICATE OF SERVICE
`
`I hereby certify that on this December 21, 2020, a copy of Petitioner’s Reply
`
`was served in its entirety by electronic mail on Patent Owner’s counsel at the
`
`following addresses indicated in Patent Owner’s Mandatory Notices:
`
`J. Derek Vandenburgh, Reg. No. 32,179
`dvandenburgh@carlsoncaspers.com
`
`Dennis C. Bremer, Reg. No. 40,528
`dbremer@carlsoncaspers.com
`
`Joseph W. Winkels
`jwinkels@carlsoncaspers.com
`
`Peter M. Kohlhepp
`pkohlhepp@carlsoncaspers.com
`
`Tara C. Norgard
`tnorgard@carlsoncaspers.com
`
`Alexander S. Rinn
`pkohlhepp@carlsoncaspers.com
`
`Megan E. Christner, Reg. No. 78,979
`mchristner@carlsoncaspers.com
`
`
`Dated: December 21, 2020
`
`
`
`
`
`Respectfully submitted,
`
`
`
`
`
`
`
`
`
`
`/ Cyrus A. Morton /
`Cyrus A. Morton
`Reg. No. 44,954
`Attorney for Petitioner
`
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`25
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