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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
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`v.
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`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
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`
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`Case IPR2020-00132
`Patent RE45,760
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`PATENT OWNER SUR-REPLY
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`TABLE OF CONTENTS
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`Page
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`I.
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`II.
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`INTRODUCTION ........................................................................................... 1
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`PETITIONER HAS NOT SHOWN THAT CLAIMS 32 AND 39 ARE
`INVALID ......................................................................................................... 2
`
`A. Ground 2 –Itou in View of Ressemann and the Knowledge of a
`POSITA (Claims 32 and 39) ................................................................. 2
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`1.
`
`Claim 32: It Would Not Have Been Obvious to Modify Itou’s
`Proximal Opening to Have “At Least Two Inclined Slopes” ..... 3
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`a.
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`b.
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`c.
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`d.
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`e.
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`Petitioner’s Expert Admits the Proposed Itou/Ressemann
`Combination Would Result in “Nominally a 2 French”
`Difference in Inner Lumen Diameters .............................. 4
`
`Petitioner’s New “Not Inventive” Theory Is Contradicted
`by Its Own Experts and Marketing ................................... 5
`
`Petitioner’s New “Three Incline” Theory is Improper and
`Wrong ............................................................................... 6
`
`Petitioner’s Ever-Changing Litany of Purported
`Motivations Are Hindsight-Based and Unpersuasive ...... 9
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`Petitioner Has Not Shown that the Resulting Structure
`Would Result in the Claimed “At Least Two Inclined
`Slopes” ............................................................................ 12
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`2.
`
`Claim 39: It Would Not Have Been Obvious to Configure Itou
`to Receive a Stent Releasably Joined to a Balloon Catheter .... 14
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`a.
`
`b.
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`Petitioner Ignores Key Differences Between Itou,
`Ressemann, and the Requirements of Claim 39 ............. 14
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`Petitioner’s Sizing Arguments Rely on New and
`Improper Evidence, and Are Wrong .............................. 16
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`B. Ground 3 –Itou in View of Kataishi and the Knowledge of a
`POSITA (Claim 32) ............................................................................ 18
`
`
`
`i
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`C.
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`Real-World Evidence of Copying by Teleflex’s Competitors Shows
`that Claim 32 Is Not Obvious .............................................................. 21
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`III. NON-AIA PATENT ...................................................................................... 25
`
`
`
`
`ii
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`
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`
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`TABLE OF AUTHORITIES
`
`
`
`Cases
`
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 (Fed. Cir. 2016) ............................................................................ 25
`
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) .............................................................................. 7
`
`Intendis GmbH v. Glenmark Pharms., Inc.,
`822 F.3d 1355 (Fed. Cir. 2016) ............................................................................ 24
`
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ..................................................................... 24, 25
`
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ................................................................................................ 2
`
`Other Authorities
`
`PTAB Consolidated Trial Practice Guide (November 2019) .................................... 7
`
`Statutes
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`35 U.S.C. § 100(i)(2) ............................................................................................... 25
`
`Rules
`
`37 C.F.R. § 42.23(b) .................................................................................................. 7
`
`
`
`iii
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`
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`I.
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`INTRODUCTION
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`The present IPR Petition should be rejected in its entirety because Itou, the
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`primary reference relied on for all Grounds, does not qualify as prior art. Paper 39;
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`Paper 96.
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`In addition, claim 32 requires a side opening with “at least two inclined
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`slopes.” But as Patent Owner (“Teleflex”) showed in its Response, and as
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`Petitioner’s original experts admitted, none of Petitioner’s references teach a such
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`a device. So, now in Reply, Petitioner seeks to change course: it appears to have
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`abandoned its Enger-based ground (Ground 4); it has abandoned one of its original
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`experts; it has enlisted a new expert; and it has added new and improper evidence.
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`Petitioner’s new theories now include that claim 32 is unpatentable because
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`the at least two-incline slope side opening “provide[s] no benefit” over a single
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`incline. Paper 83 (“Reply”), 7-8. Petitioner’s new position fails at least because
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`Teleflex’s competitors copied Teleflex’s “at least two inclined slope[]” side
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`opening design; none used a single-incline design. Moreover, Petitioner touts the
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`advantage of its two-incline “on-ramp” in advertising, and its own documents
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`show that it
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` but ultimately ended up
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`
`
` Ex-2071, 15, 18, 20; Ex-2197, 1; Ex-2138, ¶¶213-215.
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`In addition, Petitioner has failed to show that claim 39—requiring a side
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`1
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`
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`opening and distal tubular structure “configured to receive” a stent when the side
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`opening and a proximal part of the tubular structure are inside the guide catheter—
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`would have been obvious in view of Itou and Ressemann. As the Board has
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`already found, Itou does not disclose or suggest inserting its protective catheter
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`into the proximal end of the suction catheter while inside the guide catheter, and
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`even the new stent evidence Petitioner files with its Reply still does not show that
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`Itou’s raised-profile pushwire design would have been amenable to stents.
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`II.
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`PETITIONER HAS NOT SHOWN THAT CLAIMS 32 AND 39 ARE
`INVALID
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`A. Ground 2 –Itou in View of Ressemann and the Knowledge of a
`POSITA (Claims 32 and 39)
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`Petitioner incorrectly asserts that Teleflex can only refute Petitioner’s
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`evidence by showing that “a POSITA would never look to the teachings of one
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`coronary catheter . . . Ressemann (Ex-1008), to inform the use of a second, Itou
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`(Ex-1007).” Reply, 1. This is an overstatement, and also legally wrong. There
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`must always be sufficient motivation to modify one in view of the other. KSR Int’l
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`Co. v. Teleflex Inc., 550 U.S. 398, 418-19 (2007). Itou and Ressemann are
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`designed for different procedures and function in different ways. Paper 43
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`(“POR”), 9-17, 19-21; Ex-2138, ¶¶128-135; Ex-2145, ¶¶183-87. Concluding that
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`both are in the same field is not sufficient to show motivation to combine with a
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`reasonable expectation of success.
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`2
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`1.
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`Claim 32: It Would Not Have Been Obvious to Modify
`Itou’s Proximal Opening to Have “At Least Two Inclined
`Slopes”
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`It is undisputed that Ressemann does not teach a proximal opening with at
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`least two inclined slopes, as required by claim 32:
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`Single incline
`opening
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`Single incline
`opening
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`Ex-1008, Figs. 16A, 16D.
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`In Ressemann, the proximal “inclined slope” Petitioner relies on (the tip of
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`the tab 2141b) is buried inside shaft 2120 under multiple layers of material, and
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`serves no purpose in Ressemann’s device:
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`3
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`
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`POR, 22-31. Petitioner did not provide any logical reason why a POSITA would
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`be motivated to look to the shape of Ressemann’s buried collar (and in particular to
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`the shape of the collar tab) in the first place. That threshold deficiency remains.
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`
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`a.
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`Petitioner’s Expert Admits the Proposed
`Itou/Ressemann Combination Would Result in
`“Nominally a 2 French” Difference in Inner Lumen
`Diameters
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`One of the elements of independent claim 25 (from which claim 32 depends)
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`is that the inner diameter of the guide extension catheter is not more than “one
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`French size smaller” than the inner dimeter of the guide catheter. Ex-1001, 13:60-
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`62. The POR explained that Petitioner’s claim 32 theory of combining
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`Ressemann’s collar with Itou would not result in this limitation. POR, 43-45.
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`Petitioner’s new expert confirmed this, testifying it would be “nominally a 2
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`4
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`
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`French difference.” Ex-2239, 170:14-174:9. Indeed, it is plain that the
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`combination does not meet the “one French size” limitation just from the diagram
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`Petitioner provided:
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`Guide catheter
`lumen
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`Suction
`catheter lumen
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`
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`Reply, 14; Ex-1807, ¶130 (dotted red and blue lines and annotations added by
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`Teleflex). This should end the inquiry for claim 32.
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`Petitioner attempts to argue that the difference is somehow within the “one
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`French size” limitation (Reply, 15), but it does not explain its calculations and its
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`expert does not support them. Petitioner’s effort to contradict its own expert is not
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`supported by evidence. Thus, even assuming it would have been obvious to
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`combine Itou and Ressemann in the manner Petitioner advocates (which it is not
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`for the reasons explained below), the resulting structure would not meet the
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`limitations of claim 32.
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`b.
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`Petitioner’s New “Not Inventive” Theory Is
`Contradicted by Its Own Experts and Marketing
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`Apparently recognizing the weakness of its invalidity arguments, Petitioner
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`now contends that the claimed, two-inclined-slopes side opening shape “was not
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`inventive” and “provide[s] no benefit” over a single incline. Reply, 7-8. This new
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`5
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`
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`argument is belied by Petitioner’s own expert, who explained that the “on-ramp”
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`provided by the multiple-inclined slope configuration was a “benefit.” E.g., Ex-
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`1042, ¶¶90, 98, 100, 103. Petitioner’s own advertising also focuses on the benefit
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`of the Telescope’s “on-ramp.” E.g. Ex-2071, 18; see also id. 4, 15, 20.
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`Petitioner’s own documents show that it
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` (the coined term that
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`Teleflex uses to for its multi-inclined design). Ex-2197, 1; see also POR, 64-67;
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`Ex-2138, ¶215; Ex-2063, 4. In addition, Teleflex’s competitors copied the
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`multiple-inclined slope design rather than using a single incline. POR, 60-67. The
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`Board should reject Petitioner’s new “no benefit” argument out of hand.
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`c.
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`Petitioner’s New “Three Incline” Theory is Improper
`and Wrong
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`The original Petition argued that Ressemann’s support collar 2141 has two
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`inclined slopes:
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`6
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`Petition, 67. But after its original two experts admitted that the proximal incline
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`(“1” in Petitioner’s illustration) is buried inside Ressemann’s device and serves no
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`purpose (POR, 22-31), Petitioner pivoted to an entirely new theory: that
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`Ressemann’s collar 2141 actually has three inclines, illustrated with a new
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`diagram:
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`Reply, 8-15; Ex-1806, ¶¶81-90. Petitioner uses this new theory to argue that
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`middle incline B, together with incline C, forms a side opening that meets the
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`language of claim 32. Reply, 9-10, 14; Ex-1807, ¶¶130-32.
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`
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`The Board should reject all of this. New obviousness theories are not
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`permitted for the first time in reply, nor is evidence that could have been submitted
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`with the Petition. PTAB Consolidated Trial Practice Guide (November 2019), 73-
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`74; 37 C.F.R. § 42.23(b); Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd.,
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`821 F.3d 1359, 1369-70 (Fed. Cir. 2016). Petitioner’s new engineering expert
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`even agreed that he and Petitioner’s original engineering expert “came to two
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`different conclusions.” Ex-2239, 83:15-84:10. It would be patently unfair for the
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`7
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`Board to consider this new argument when Teleflex has not been permitted to
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`respond with evidence.
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`Petitioner seeks to disguise how jarringly new this theory is by pointing to
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`testimony from Teleflex witnesses about inclines in other things. Reply, 8-9,
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`citing Ex-1800, 45:21-46:2 (testimony about GuideLiner V1) and Ex-1762, 91:24-
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`93:24 (testimony about VSI’s July 2005 GuideLiner prototype). None of this
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`testimony is about what Ressemann discloses. Further, Petitioner cannot
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`manufacture an excuse to present a new argument by forcing Teleflex’s witnesses
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`to answer questions that Petitioner then asserts justifies the new argument.
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`
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`Nor does Petitioner’s new evidence, even if considered, support its new
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`argument. Petitioner does not show that the testimony about the proximal opening
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`shapes of the GuideLiner V1 and the GuideLiner July 2005 prototype establishes
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`anything about what Ressemann’s collar discloses. Further, Petitioner’s experts
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`formed their new opinion by analyzing a perspective view that makes it appear as
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`if there might be a change of angle along the inclined portion:
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`8
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`
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`Reply, 10. But this view is misleading. Indeed, Petitioner’s first technical expert
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`presented what he thought a side view of Ressemann’s collar would look like,
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`plainly showing only a single incline near the full circumference:
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`Single
`incline
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`Ex-1042, ¶92 (red annotations in original; blue annotations added). Petitioner’s
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`attempt to replace and contradict the testimony of its first engineering expert with
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`that of a second (new) engineering expert is improper.
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`
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`The Board should disregard Petitioner’s new “three inclines” theory—it is
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`both outside the scope of a permitted Reply and unsupported.
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`d.
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`Petitioner’s Ever-Changing Litany of Purported
`Motivations Are Hindsight-Based and Unpersuasive
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`Petitioner seeks to rely on a moving-target series of purported motivations.
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`The Petition asserted two alleged motivations: (1) increasing the area for receiving
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`a stent and/or balloon catheter; and (2) the concavity of tab 2141b ensures the
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`support collar can serve as a guide for receiving interventional devices. Petition 66.
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`Additionally, Petitioner’s original expert, Hillstead, identified four alleged benefits:
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`(a) reinforcing the lumen opening; (b) providing a flexibility transition; (c)
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`providing a large area for receiving interventional devices; (d) providing an “on-
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`9
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`ramp.” Ex-1042, ¶90.
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`Petitioner’s Reply completely ignores purported motivation (ii)/(d)—
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`providing a “guide” or “on-ramp” for interventional devices. See Reply, 10-15. In
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`fact, Petitioner specifically directed its new expert to not consider this motivation.
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`Ex-2239, 72:13-73:9. This is not surprising given the undisputed evidence that the
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`so-called “first incline” at the tip of Ressemann’s collar tab 2141b plays no part in
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`the shape of Ressemann’s proximal opening.
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`Regarding the Petition’s only other alleged motivation—“increasing the
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`area”—Petitioner’s Reply ignores the critical admission of its original technical
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`expert, who agreed that a larger opening is solely due to a less-steep inclined
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`region, and unrelated to two inclines. Ex-2137, 194:21-196:6; see also POR, 31-33.
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`Moreover, looking to the shape of Ressemann’s entire collar, including the tab
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`portion 2141b, to provide increased area for receiving interventional devices is pure
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`hindsight, as Ressemann’s collar tab indisputably does not serve that function in
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`Ressemann. POR, 31-33.
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`The other two “benefits” articulated by Hillstead—“flexibility transition”
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`and “reinforcing” the proximal opening—remain unsupported. The POR pointed
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`out that the flexibility transition provided by the collar tab makes sense in
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`Ressemann, where multiple polymer lumens in the shaft must maintain their
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`patency for the device to operate properly. POR, 36-38. Itou’s device has no such
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`10
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`
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`lumens and has a metal proximal tip that is “secured firmly” via a weld to a metal
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`pushwire. Id. Petitioner’s position that a POSITA would nonetheless be motivated
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`to extract Ressemann’s entire collar and engineer it into Itou’s device because of a
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`“potential weakness” is not credible. See Reply, 12-13. Petitioner’s new expert
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`points to several references disclosing various different “transition” structures. Ex.
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`1807, ¶¶52-57. None involves a simple metal-pushrod-to-metal-collar connection
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`like that in Itou, where there is no change in material or stiffness at the “transition”
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`point. See id; Ex-2239, 100:20-101:3 (Petitioner’s new expert admitting “I don’t
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`think I’m aware of a catheter where there are two metal portions joined by a . . .
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`transitional member”).
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`As for “reinforcing” the proximal opening, the POR pointed out that Itou’s
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`proximal opening needed no reinforcement because it is already formed from a
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`“metal pipe.” POR, 35. In Reply, Petitioner now takes the opposite position,
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`arguing that Itou’s proximal opening has too much reinforcement and that a
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`POSITA would be motivated to incorporate Ressemann’s thinner collar into Itou’s
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`opening because it would provide less reinforcement. Reply, 11-12. Such moving-
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`target positions only further demonstrate the hindsight nature of Petitioner’s
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`arguments.
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`11
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`e.
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`Petitioner Has Not Shown that the Resulting
`Structure Would Result in the Claimed “At Least
`Two Inclined Slopes”
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`The POR showed that mounting Ressemann’s collar on Itou’s pushwire
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`would be a challenging engineering proposition and create a ledge that would serve
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`as a catchpoint. POR, 41-43. Teleflex also showed that, while Petitioner’s expert
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`relied on the “way” Ressemann taught to incorporate the collar (Ex-1042, ¶101),
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`that “way” would not lead to the structure of claim 44. POR, 18019, 39-40.
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`In Reply, Petitioner’s new expert1 purports to address these problems by
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`arguing that the entire structure would simply be encased in enough polymer and
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`“resin layers” to securely hold the tab portion of Ressemann’s collar on Itou’s
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`pushwire and erase any ledge. Reply, 13 (citing Ex-1807, ¶¶ 90-96, 129-132).
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`1 After the first round of depositions, Petitioner dropped its first engineering expert
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`(who also did not meet his own definition of a POSITA) and retained another, Mr.
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`Jones. Ex-2239, 13:7-10. But Jones never reviewed the GuideLiner patent claims
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`(except claim 1 of the ’032 patent) and has never designed a coronary catheter. Id.,
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`14:16-16:15, 26:11-17. Further, he was prevented from considering how the collar
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`component was used in Ressemann. Ex-1807, ¶82. Jones’ entire role is an
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`exercise in hindsight and his testimony should be given no weight.
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`12
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`
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`Petitioner’s new expert illustrates the cross-section of the resulting structure:
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`Ex-1807, ¶130.
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`
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`Even if this was correct (which it is not, see Ex-2138, ¶151), this proposed
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`solution ignores a third problem with the combination: the extremely small size of
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`“incline 1,” which would disappear inside that added material. Ex-2138, ¶150.
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`Petitioner and its new expert provide a single assertion that the shape of the two
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`inclined slopes would be “retained” (Reply, 14; Ex-1807, ¶131), but neither
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`Petitioner nor its expert provide any evidence or explanation to support this.
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`Indeed, when Petitioner’s expert was asked whether he knew the dimensions of the
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`tiny “angle 1” at the tip of Ressemann’s tab to compare to the polymer coating he
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`was proposing, he conceded that he had “not worked that out or provided an
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`opinion on that.” Ex-2239, 116:19-24. Further, there is no evidence a POSITA
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`would be motivated to preserve it, particularly given the undisputed evidence that
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`the incline serves no purpose in Ressemann. POR, 22-31.
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`13
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`
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`Petitioner alternatively argues that the tab portion of Ressemann’s collar
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`could be located under Itou’s pushwire and that the resulting structure would still
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`have two inclines due to the alleged new “third incline.” Reply, 14. As discussed
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`above, this untimely and unsupported argument should be rejected.
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`2.
`
`Claim 39: It Would Not Have Been Obvious to Configure
`Itou to Receive a Stent Releasably Joined to a Balloon
`Catheter
`
`a. Petitioner Ignores Key Differences Between Itou,
`Ressemann, and the Requirements of Claim 39
`
`Petitioner argues that even though Itou teaches preassembly outside the body
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`of suction catheter 2 and protective catheter 5, whereas claim 39 requires that the
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`side opening be capable of receiving a stent releasably joined to a balloon catheter
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`while positioned in the guide catheter, Itou is nonetheless relevant. Reply, 2.
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`Specifically, Petitioner argues that catheter 2’s side opening can be positioned to
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`receive a stent releasably joined to a balloon catheter like claim 39. Id. But even if
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`catheter 5 can be withdrawn from catheter 2 in Itou, this is very different from
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`inserting a stent.
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`Recognizing this discrepancy, Petitioner claims that Itou and Ressemann are
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`analogous art and that Itou inherently disclosed the capability to receive a balloon-
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`expandable stent. Id., 3-5. But it is not at all obvious to configure Itou in view of
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`Ressemann to receive a stent catheter—indeed, this could be very dangerous.
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`While Ressemann disclosed inserting interventional cardiology devices like stents,
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`14
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`
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`Ressemann was an embolic protection device: it was specifically designed to catch
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`loose emboli dislodged by a stent. POR, 19. Itou, on the other hand, is not an
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`embolic protection device. Teleflex showed that inserting an interventional
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`cardiology device down Itou’s suction catheter posed a “real risk” of pushing
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`thrombotic material out into the bloodstream (POR, 46), and Petitioner’s own
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`cardiologist expert agreed this is “a potential risk” (Ex-2240, 14:24-15:13). Itou’s
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`suction catheter, unlike Ressemann’s embolic protection device, had no
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`mechanism for mitigating these dislodged emboli.
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`Further, it is not true that Itou in view of Ressemann renders claim 39
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`obvious “while requiring not a single change,” as Petitioner contends. Reply, 2.
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`Petitioner’s expert admitted that he did not know whether stents could navigate the
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`transition into Itou’s suction lumen, given its raised profile pushwire design. Ex-
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`2239, 66:1-6, 67:15-68:13 (an approaching stent is “offset” from the proximal
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`opening of the suction lumen, and he would have to perform tests to determine
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`what could pass through the opening). Itou’s raised profile pushwire is not an
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`issue for a suction catheter such as Itou that sucks soft thrombus distally-to-
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`proximally. In fact, Itou’s robust pushwire is important to its disclosed
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`functions—Itou explains that it is intended that the operator be able to rotate the
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`pushwire, and thereby rotate the distal end suction tube. Ex-1007, 2:19-21, 7:20-
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`24 (“the suction catheter 2 is operated so as to be rotated”). Petitioner’s experts
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`15
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`
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`agree. Ex-2239, 43:16-19 (“yes, I believe it’s important for Itou to be able to
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`rotate”); Ex-2238, 151:5-14.
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`In a further attempt to tie Itou to Ressemann, Petitioner misleadingly claims
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`that inventor Root testified that the GuideLiner “grew from” prior work on a
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`suction catheter. Reply, 3. Even if true, this would be legally irrelevant. 35
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`U.S.C. §103 (“Patentability shall not be negated by the manner in which the
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`invention was made.”). And it is not true. The cited testimony merely states that
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`VSI contemplated using reinforced polymer tubing similar to that used in its
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`Pronto suction catheter for the distal tubular section of GuideLiner. Ex-1762,
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`44:22-47:1.
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`b.
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`Petitioner’s Sizing Arguments Rely on New and
`Improper Evidence, and Are Wrong
`
`In an effort to prove that Itou’s device is “configured to receive one or more
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`stents or balloon catheters,” the Petition relied on evidence showing (i) that the
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`tubular portion of Itou’s suction catheter has an ID (inner diameter) of 0.059”; and
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`(ii) that commercially-available stents in 2005 could be delivered through a
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`catheter having an ID of 0.056”. Petition, 69 (referencing claim 25 argument at
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`63-64). But Itou’s pushwire partially blocks the opening into the tubular portion,
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`leaving it with an effective opening size of only 0.046”. POR, 47-48. This is not
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`surprising, as Itou is a suction catheter, not a guide extension catheter. Id.; see also
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`Ex-2138, ¶¶164-165.
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`16
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`
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`In its Reply, Petitioner submits new evidence purporting to show stents with
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`a “crossing,” “crimped,” or “deflated” profile less than 0.046”. Reply, 4. But this
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`is exactly the sort of “gap-filling” new evidence that should not be submitted for
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`the first time in reply.
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`Even if considered, Petitioner’s improper new evidence would not change
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`the result. Even the newly identified stents still required a minimum guide catheter
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`ID of at least 5 French (which is 0.056”), or was silent on the size of the guide
`
`catheter. E.g., Ex-1802, 25 (a “[n]on-expanded profile” of 0.038”, but requires
`
`“[m]inimal internal diameter of guiding catheter” of 0.056”); id., 7-8 (“compatible
`
`with a 5 Fr guiding catheter”), Ex-1804, 6, Table 2 (compatible with the 5F
`
`guiding catheter).
`
`Petitioner also argues that Itou is capable of receiving stents because (i) its
`
`pushwire is flexible and can bend out of the way; and (ii) the combination of the
`
`side opening and the flattened weld point proximal to the opening provides space
`
`for a stent to enter the tubular portion. Reply, 5-6. These arguments ignore two
`
`important points. One, claim 25 requires that the side opening be capable of
`
`receiving the interventional cardiology devices when “positioned within the lumen
`
`of the guide catheter.” When Itou’s suction catheter is inserted into the guide
`
`catheter, the pushwire is constrained by the walls of the guide catheter and has no
`
`ability to “bend” out of the way. Ex-2238, 110:20-111:24. Two, Petitioner ignores
`
`17
`
`
`
`how much longer stents are than the opening. Petitioner’s new evidence indicates
`
`that stents range in length from 8-30mm. Ex-1802. Using the dimensions
`
`provided by Petitioner’s new technical expert, the combined length of Itou’s side
`
`opening and flattened weld point is slightly over 3mm. See Ex-1807, ¶125.2 Even
`
`the shortest stent is more than double the length of Itou’s weld point/angled region.
`
`B. Ground 3 –Itou in View of Kataishi and the Knowledge of a
`POSITA (Claim 32)
`
`The Board’s Institution Decision preliminarily found that Petitioner had not
`
`“explain[ed] sufficiently why the inclined shape of Kataishi’s distal opening would
`
`have been applicable to the [proximal] opening” of Itou’s suction catheter. Paper
`
`22, 25. That is still the case. The purpose of Kataishi’s distal opening shape is to
`
`allow the distal end to flex and conform about a thrombus formed on a vessel wall,
`
`thereby “enhance[ing] suction”—a purpose that is indisputably inapplicable to
`
`Itou’s rigid metal proximal collar. Ex-2138, ¶168; Ex-2145, ¶152.
`
`Petitioner now argues that a POSITA would nonetheless have been
`
`motivated to apply Kataishi’s distal opening shape to Itou’s proximal end because
`
`
`2 Using the dimensions provided by Jones (Ex-1807, ¶125), and the Pythagorean
`
`theorem, the length of Itou’s side opening is 2.45mm. Jones estimated the length
`
`of the weld to be ~0.0295” (0.75mm), yielding a total length of 3.2mm. Ex-2239,
`
`35:16-36:14.
`
`18
`
`
`
`the Ressemann reference allegedly teaches that the proximal and distal ends of
`
`Ressemann’s evacuation head contribute to smooth passage of therapeutic devices.
`
`Reply, 15-17. This argument fails for at least three reasons.
`
`First, it is untimely. Petitioner’s Ground 3 was not “Itou in view of Kataishi
`
`and Ressemann”; it did not ever rely on Ressemann.
`
`Second, the cited passage of Ressemann is ambiguous, and Petitioner’s
`
`interpretation of it is hindsight-driven. Reply, 16. The passage states that the ends
`
`of Ressemann’s evacuation head are angled to do two things, but that does not
`
`mean that both angles serve both functions. See Ex-1008, 6:52-57. Indeed,
`
`contrary to Petitioner’s hindsight-driven reading, Ressemann later assigns one
`
`function to each angled portion. Id., 7:48-53; 23:17-20.
`
`Third, the shape of the proximal and distal openings in the cited Ressemann
`
`embodiment itself are different from one another, and the proximal opening is a
`
`simple angled skive (just like in Itou). Id., Fig. 1A. If anything, a POSITA would
`
`conclude the shape of the proximal opening should not be the same as the distal
`
`opening. The below comparison shows that a POSITA would not be motivated by
`
`the shape of a distal end to modify a proximal opening:
`
`
`
`19
`
`
`
`Ressemann straight-angled
`proximal opening
`
`Ressemann curved distal
`end
`
`Kataishi curved distal
`suction tip
`
`Ex-1008, Fig. 1A; Ex-1025, Fig. 12.
`
`
`
`With more hindsight, Petitioner next argues that a POSITA would be
`
`motivated to apply Kataishi’s distal opening shape to Itou’s proximal opening
`
`because it would provide a larger size to facilitate introduction of stents and
`
`balloon catheters into Itou’s device. Reply, 16-17. But neither Kataishi nor Itou
`
`mention delivering stents or balloons. Petitioner also ignores Teleflex’s evidence
`
`(and the admission of Petitioner’s original expert) that the increased size does not
`
`depend on having a complex, multi-angle shape, but rather on how “sharp” one
`
`chooses to angle the opening. See POR, 31-33.
`
`Finally, Petitioner’s renewed assertions regarding “crossability” rely on
`
`illogical and unsupported inferences. Reply, 18. Petitioner still does not explain
`
`how this purported benefit of the distal tip of Kataishi—which tracks through the
`
`20
`
`
`
`guide catheter and/or vasculature—relates at all to Itou’s proximal opening.
`
`Petitioner points to the Sakurada reference, which it says describes testing
`
`confirming that the shape of Kataishi’s distal end improves crossability. Id. But
`
`the cited pages do not say that. Ex-1055, 6, 8. And the Sakurada “passing test” it
`
`cites is irrelevant—Sakurada attributes crossability to Kataishi’s support wire that
`
`runs the length of the device, not the distal tip shape. Ex-1055, 10. The only
`
`benefit it attributes to the shape of the distal opening is increased suction due to its
`
`ability to flex and conform to the side wall of the vessel, which does not relate to
`
`accepting interventional devices. Id., 8, 10.
`
`C. Real-World Evidence of Copying by Teleflex’s Competitors
`Shows that Claim 32 Is Not Obvious
`
`Each of Teleflex’s three U.S. competitors—Petitioner, Boston Scientific,
`
`and QXM—closely copied GuideLiner, including the complex side opening shape
`
`recited in claim 32. POR, 60-67. Petitioner’s responses are unavailing, and seem
`
`to be an effort to argue, circularly, that copying should be disregarded because the
`
`invention was obvious. But the very purpose of objective evidence is to serve as a
`
`reality check against hindsight-based reconstructions of prior art.
`
`Petitioner appears to argue that Telescope and GuideLiner do not meet the
`
`size limitation of claim 32, pointing out that “one French” is mathematically
`
`21
`
`
`
`defined as 0.0131 inch.3 Reply, 21. But claim 32 merely requires the lumen of the
`
`GEC be “not more than one French size smaller” than the lumen of the guide
`
`catheter. Ex-1001, cl. 25, 32. The ’760 patent specification explains that a “one
`
`French size” difference can be 0.014”. Id., 3:43-51 (the internal diameter of a 6
`
`French guide catheter is “greater than or equal to 0.070 inches”, and the internal
`
`diameter of the 5 French GEC should be “greater than or equal to 0.056 inches”);
`
`Ex-2138, ¶46.
`
`This makes sense because catheters are typically sized by their outer
`
`diameter, while the inner diameter varies depending not just on outer diameter, but
`
`also on wall thickness. Ex-2138, ¶46. Petitioner’s experts agree that when one
`
`was talking about two nested catheters and a one French size difference in inner
`
`diameters, a POSITA would have understood that it was not exactly 0.0131 inches.
`
`Ex-2239, 155:17-156:24 (“you’d have to have some allowance or variation”); Ex-
`
`2137, 371:25-372:9; see also id., 370:14-371:20. Both GuideLiner and Telescope
`
`meet this limitation. Ex-2138, ¶214 and Appx B, 146-147.
`
`
`3 Petitioner’s argument is actually made with respect to Claim 53 of the ʼ776
`
`patent. Teleflex assumes this is a mistake and presumes that the argument applies
`
`to Claim 32 of the ʼ760 patent. However, given the argument is not clear, any
`
`ambiguities should be resolved in Teleflex’s favor.
`
`22
`
`
`
`Petitioner’s Telescope does not “practice[] the prior art.” Reply, 23.
`
`Petitioner cites Kontos, Ressemann, and Itou (Reply, 19-20), but Kontos did not
`
`have a side opening at all and Ressemann and Itou had only single-angle proximal
`
`side openings. POR, 17, 22. That an embedded, internal component of
`
`Ressemann (collar 2141) may have two angles if viewed in isolation is irrelevant.
`
`Id., 17-19.
`
`Petitioner does not disp
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