UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`MEDTRONIC, INC., AND MEDTRONIC VASCULAR, INC.
`Petitioners,
`
`v.
`
`TELEFLEX INNOVATIONS S.A.R.L.
`Patent Owner.
`
`
`
`
`Case IPR2020-00126
`Patent 8,048,032
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`PATENT OWNER SUR-REPLY TO PETITIONER’S REPLY
`
`

`

`TABLE OF CONTENTS
`
`Introduction ...................................................................................................... 1
`
`I.
`
`II. The Proper Construction of “Through Which Interventional Cardiology
`Devices Are Insertable” Is Dispositive Against the Petition (All
`Challenged Claims) ......................................................................................... 2
`
`A.
`
`“Through Which Interventional Cardiology Devices Are Insertable”
`Requires at Least the Defined Set of Guidewires, Balloon Catheters,
`Stents, and Stent Catheters Are Insertable .............................................. 3
`
`B.
`
`“Interventional Cardiology Device” ....................................................... 5
`
`III. All Challenged Claims (Ground 1): Petitioner Has Not Shown that Itou’s
`Lumen Has the Claimed Structure With a “cross-sectional inner diameter
`through which interventional cardiology devices are insertable” Under
`Either Construction .......................................................................................... 7
`
`A.
`
`Itou’s Protective Catheter Is Not an “Interventional Cardiology
`Device” as That Term Is Defined and Used in the ’032 Patent .............. 7
`
`B. Petitioner’s New Inherency Argument Is Untimely and It Would
`Be Unfairly Prejudicial for the Board to Consider It .............................. 8
`
`C. Petitioner’s New Inherency Argument Is Unpersuasive, Even If
`the Board Were to Consider It ................................................................ 9
`
`IV. Dependent Claims 3, 13, and 14 (Grounds 1 and 2) ..................................... 11
`
`A. Petitioner Failed to Show that Itou Anticipates Claims 3, 13, or 14
`(GROUND 1) ........................................................................................ 11
`
`B. Claim 3 Would Not Have Been Obvious in View of Itou and
`Ressemann (GROUND 2) ..................................................................... 13
`
`C. Claim 13 Would Not Have Been Obvious in View of Itou and
`Ressemann (GROUND 2) ..................................................................... 15
`
`D. Claim 14 Is Not Obvious in View of Itou and Ressemann
`(GROUND 2) ........................................................................................ 17
`
`i
`
`

`

`V. Dependent Claim 6 (GROUND 1): Itou Does Not Anticipate Because
`Its Distal Tip Portion Is Not Cylindrical ....................................................... 17
`
`VI. Petitioner Has Not Refuted the Striking Objective Evidence that
`Confirms Claims 3 and 13 Were Not Obvious .............................................. 18
`
`A. The Objective Evidence, Including Nexus, Is Undisputed ................... 18
`
`B. The Combination of Features That Resulted in GuideLiner’s
`Success and Praise Is Not in the Prior Art ............................................ 18
`
`C. The Fact that All of GuideLiner’s Competitors Copied its Design
`Confirms Non-Obviousness .................................................................. 20
`
`VII. Non-AIA Patent ............................................................................................. 22
`
`CERTIFICATE OF WORD COUNT COMPLIANCE ........................................... 24
`
`CERTIFICATION OF SERVICE............................................................................ 25
`
`
`
`
`ii
`
`

`

`TABLE OF AUTHORITIES
`
`
`
`Cases
`
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 (Fed. Cir. 2016) ............................................................................ 22
`
`In re Magnum Oil Tools Int'l, Ltd.,
`829 F.3d 1364 (Fed. Cir. 2016) ............................................................................ 11
`
`Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) .............................................................................. 9
`
`Iron Grip Barbell Co. v. USA Sports, Inc.,
`392 F.3d 1317 (Fed. Cir. 2004) ..................................................................... 21, 22
`
`Jack Guttman, Inc. v. Kopykake Enters.,
`302 F.3d 1352 (Fed. Cir. 2002) .............................................................................. 3
`
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................. 13
`
`Lectrosonics, Inc. v. Zaxcom, Inc.,
`IPR2018-01129, Paper 33 (PTAB Jan. 24, 2020) ................................................ 19
`
`Mytee Prods., Inc. v. Harris Rsch, Inc.,
`439 F. App’x 882 (Fed. Cir. 2011) ...................................................................... 11
`
`Tech. Patents LLC v. T-Mobile UK, Ltd.,
`700 F.3d 482 (Fed. Cir. 2012) ................................................................................ 6
`
`Vitronics Corp. v. Conceptronic,
`90 F.3d 1576 (Fed. Cir. 1996) ................................................................................ 3
`
`WBIP, LLC v. Kohler Co.,
`829 F.3d 1317 (Fed. Cir. 2016) ..................................................................... 19, 20
`
`Statutes
`
`35 U.S.C. § 103 ........................................................................................................ 14
`
`35 U.S.C. § 312(a)(3) ................................................................................................. 9
`
`iii
`
`

`

`Other Authorities
`
`37 C.F.R. § 42.23(b) .................................................................................................. 9
`
`PTAB Consolidated Trial Practice Guide (November 2019) .................................... 9
`
`iv
`
`

`

`I.
`
`Introduction
`
`The challenged claims are directed to a guide extension catheter (“GEC”)
`
`with rapid exchange capability through which at least a defined set of
`
`“interventional cardiology devices” are insertable. Petitioner’s reliance on Itou, a
`
`suction catheter designed for an entirely different purpose, is unavailing. Petitioner
`
`does not persuasively explain why the Board should ignore the patent’s express
`
`definition of “interventional cardiology devices” as including at least guidewires,
`
`balloon catheters, stents and stent catheters. Even under the Board’s preliminary
`
`construction requiring only two such devices, the Petition incorrectly relies on
`
`Itou’s protective catheter, which the patent itself makes clear, is not an
`
`interventional cardiology device. What’s more, Itou’s protective catheter is
`
`inserted into Itou’s suction catheter only outside the body. Unlike the GuideLiner
`
`invention, Itou does not receive anything into its proximal opening after it is
`
`loaded into a guide catheter.
`
`Recognizing the deficiencies in its Petition, Petitioner raises an inherency
`
`argument for the first time in Reply. This is a transparent attempt to belatedly gap-
`
`fill in contravention of PTAB rules and in violation of Patent Owner’s (“Teleflex”)
`
`due process. Even if considered, Petitioner’s new argument is not supported by
`
`any evidence.
`
`1
`
`

`

`Ground 2’s obviousness arguments against claims 3, 13, and 14 likewise
`
`fail. Petitioner does not show that a POSITA would be motivated to combine Itou
`
`and Ressemann with a reasonable expectation of success. Moreover, there is
`
`unusually compelling objective evidence of non-obviousness in this case. The
`
`GuideLiner as embodied by the claims was a groundbreaking product that solved a
`
`long-felt need in interventional cardiology and garnered widespread industry praise
`
`and copying by competitors. Petitioner fails to show that the challenged claims are
`
`unpatentable.
`
`II. The Proper Construction of “Through Which Interventional
`Cardiology Devices Are Insertable” Is Dispositive Against the Petition
`(All Challenged Claims)
`
`
`
`The Board must resolve two distinct claim construction issues for the ’032
`
`patent: (i) whether the claim phrase “through which interventional cardiology
`
`devices are insertable” requires structure through which at least the defined set of
`
`guidewires, balloon catheters, stents and stent catheters are insertable; and (ii)
`
`whether “interventional cardiology devices” encompasses things like Itou’s
`
`protective catheter that do not extend past the end of the guide catheter to provide
`
`treatment.
`
`Petitioner incorrectly contends that resolution of these claim construction
`
`issues “does not impact the outcome of this IPR.” Paper 83 (“Reply”), 2. The
`
`Petition did not cite any evidence showing that Itou has the structure through
`
`2
`
`

`

`which balloon catheters, stents, and stent catheters are insertable as claimed,
`
`relying instead on Itou’s pre-loaded protective catheter 5. Paper 43, Patent Owner
`
`Response (“POR”), 9-11 and 19-21. If the Board rules in Teleflex’s favor on
`
`either of these issues, the IPR fails on all grounds.
`
`A.
`
`“Through Which Interventional Cardiology Devices Are
`Insertable” Requires at Least the Defined Set of Guidewires,
`Balloon Catheters, Stents, and Stent Catheters Are Insertable
`
`
`Petitioner’s Reply ignores one of the key points in the POR. The
`
`specification expressly defines “interventional cardiology devices” as including at
`
`least the set of guidewires, balloon catheters, stents, and stent catheters. POR, 9-
`
`10. If a claim covered a device that could only receive one or two such devices, it
`
`would use the conjunctive “or.” Id., 10. A patentee can be his or her own
`
`lexicographer when the definition of the term “is clearly stated in the patent
`
`specification or file history.” Vitronics Corp. v. Conceptronic, 90 F.3d 1576, 1582
`
`(Fed. Cir. 1996). When the patentee has clearly defined the term, “that definition
`
`‘usually . . . is dispositive; it is the single best guide to the meaning of a disputed
`
`term.’” Jack Guttman, Inc. v. Kopykake Enters., 302 F.3d 1352, 1360 (Fed. Cir.
`
`2002) (quoting Vitronics, 90 F.3d at 1582). Petitioner’s Reply does not address
`
`this.
`
`In response to Teleflex’s argument regarding the specification’s discussion
`
`of “standard coronary devices,” Petitioner misapprehends Teleflex’s argument.
`
`3
`
`

`

`Reply, 4-5. Teleflex does not argue that “standard coronary devices” and
`
`“interventional cardiology devices” are synonymous. Rather, Teleflex’s point is
`
`that the specification’s express definition of “interventional cardiology devices” as
`
`requiring a minimum set of devices including stents and balloon catheters, rather
`
`than just any one or two of such devices, is consistent with the purpose of the
`
`invention. POR, 10-11.
`
`Construing the claim phrase “through which interventional cardiology
`
`devices are insertable” to require only a guidewire and not a stent or balloon
`
`catheter, for example, would be inconsistent with the clearly stated purpose of the
`
`invention as accepting “standard coronary devices.” Petitioner does not dispute
`
`that stents and balloon catheters are some of the most common “standard coronary
`
`devices.” POR, 10-11. What’s more, the Summary of the Invention describes the
`
`invention as a “coaxial guide catheter,” i.e., a structure that serves the same basic
`
`function (delivering interventional cardiology devices) as the guide catheter in
`
`which it is placed. Ex-1001, 2:53–64. Petitioner’s expert, Dr. Zalesky, agrees that
`
`in view of how the term “interventional cardiology devices” is defined by the
`
`GuideLiner patent specification, the invention has to be able to deliver stents and
`
`stent catheters. Ex-2242, 88:18-89:18.
`
`
`
`Teleflex asks the Board to reconsider its preliminary claim construction and
`
`properly interpret the phrase “through which interventional cardiology devices are
`
`4
`
`

`

`insertable” consistent with the definition in the specification to require structure
`
`through which at least the defined set of guidewires, balloon catheters, stents, and
`
`stent catheters are insertable.
`
`B.
`
`“Interventional Cardiology Device”
`
`
`
`
`Petitioner disputes that “interventional cardiology device” requires a device
`
`that provides treatment to a location in the cardiac vasculature. Reply, 3-5. With
`
`this argument, Petitioner asks the Board to improperly ignore how the ’032 patent
`
`defines and uses that term in favor of a broader general meaning based on extrinsic
`
`evidence. See Ex-1806 ¶¶10-13 (relying only on extrinsic evidence); Ex-2238,
`
`18:1-4 (Petitioner’s expert construing the term as merely “those devices which
`
`would go into a [GEC]”).
`
`Petitioner’s contention that the specification does not use the term
`
`“interventional cardiology device” interchangeably with “cardiac treatment device”
`
`and “interventional cardiology treatment device” is belied by the specification,
`
`which expressly refers to the same set of devices, including guidewires, as both
`
`“interventional cardiology devices” and “cardiac treatment device[s]”:
`
`•
`
`“[T]he term ‘interventional cardiology devices’ is to be understood to
`
`include but not be limited to guidewires, balloon catheters, stents and
`
`stent catheters.” Ex-1001, 1:19-21.
`
`5
`
`

`

`•
`
`“[A] cardiac treatment device, such as a guidewire, balloon, or stent.”
`
`Ex-1001, 4:30-31.
`
`Petitioner cites no authority for the proposition that different words in the
`
`specification are presumed to have different meanings. Indeed, patentees can and
`
`often do use words interchangeably, which informs claim construction. E.g. Tech.
`
`Patents LLC v. T-Mobile UK, Ltd., 700 F.3d 482, 492 (Fed. Cir. 2012) (“[T]he
`
`patent uses the terms ‘receiving user’ and ‘subscriber’ interchangeably.”).
`
`Petitioner also ignores that the patent expressly differentiates devices that might
`
`broadly be considered interventional cardiology tools, like protective catheters,
`
`from “interventional cardiology device[s]”. POR, 12-14.
`
`Finally, Petitioner contends that Teleflex’s construction is incorrect because
`
`it would read out guidewires, which Petitioner contends do not provide treatment.
`
`Reply, 5. Petitioner is wrong, and its citation to Teleflex’s expert testimony is
`
`highly misleading. Dr. Graham agreed that guidewires are not “routinely” used
`
`alone to treat a lesion (Ex-1801, 89:2-4), but he testified unequivocally that
`
`guidewires alone do provide treatment, by restoring some blood flow. Ex-1813,
`
`108:25-109:3; see also id. 107:12-21 (same). Petitioner cites nothing to the
`
`contrary. In fact, Petitioner’s cardiologist expert agrees that passing a guidewire
`
`through a blocked blood vessel can itself restore “some flow” and “that’s not a bad
`
`thing.” Ex-2238, 20:21-21:8.
`
`6
`
`

`

`III. All Challenged Claims (Ground 1): Petitioner Has Not Shown that
`Itou’s Lumen Has the Claimed Structure With a “cross-sectional inner
`diameter through which interventional cardiology devices are insertable”
`Under Either Construction
`
`The Petition relied only on Itou’s protective catheter for independent claim 1
`
`and only on the protective catheter and a guidewire for independent claim 11. See
`
`Petition at 26, 55. Teleflex Response explained that Itou’s protective catheter is
`
`not an interventional cardiology device, and therefore the Petition’s challenge fails.
`
`POR, 19-23. This is true under both the correct construction, which requires
`
`structure defining a coaxial lumen through which at least guidewires, balloon
`
`catheters, stents, and stent catheters are insertable, and under the Board’s
`
`construction, which requires structure through which at least two of those are
`
`insertable. Id.
`
`A.
`
`Itou’s Protective Catheter Is Not an “Interventional Cardiology
`Device” as That Term Is Defined and Used in the ’032 Patent
`
`
`Petitioner argues that Itou’s protective catheter is an interventional
`
`cardiology device. Reply, 3-5. Yet Petitioner does not (and cannot) dispute that
`
`the ’032 patent specification expressly differentiates between “interventional
`
`cardiology devices” and “tapered inner catheter”. POR, 12-13. Petitioner’s expert
`
`agrees that the “tapered inner catheter” of the ’032 patent is like Itou’s protective
`
`catheter. Ex-2238, 26:2-10. And Petitioner does not dispute that Itou’s protective
`
`catheter does not provide treatment. Reply, 4-5 (“even assuming a tapered inner
`
`7
`
`

`

`catheter does not provide treatment . . .”). Nor could it—the express purpose of a
`
`protective catheter is to protect heathy tissue. POR, 14. Petitioner has failed to
`
`carry its burden to show either independent claim 1 or 11, and therefore any
`
`challenged claim is anticipated.
`
`B.
`
`Petitioner’s New Inherency Argument Is Untimely and It Would
`Be Unfairly Prejudicial for the Board to Consider It
`
`
`
`Petitioner tries to argue, for the first time in Reply, that Itou inherently
`
`discloses that all four types of enumerated interventional cardiology devices are
`
`insertable through its suction catheter. Reply, 1, 6-9. Petitioner made no such
`
`inherency arguments regarding the coaxial lumen “through which interventional
`
`cardiology devices are insertable” in its Petition. See Paper 1 (“Petition”), 26-28,
`
`55; see also POR, 19-23. Petitioner’s new inherency argument also relies
`
`extensively on new evidence (Reply, 6 (citing new Exs-1802, -1803, and -1804, a
`
`new page of Ex-1015b (a 200+ page textbook), and new expert testimony)) to gap-
`
`fill the Petition’s deficiencies.1
`
`
`1 Petitioner dropped its first engineering expert, Hillstead, who did not meet
`
`Petitioner’s own definition of a POSITA, after he was deposed. Ex-2239, 13:7-
`
`10. Petitioner’s new expert, Jones, never reviewed the GuideLiner patent claims
`
`(except claim 1 of the ’032) and has never designed a coronary catheter. Id.,
`
`14:16-16:15, 26:11-17. Moreover, he admitted that his opinions were based at
`
`8
`
`

`

`Such new argument and evidence in Reply is contrary to IPR rules and, if
`
`accepted, would prejudice Teleflex’s due process rights to fairly respond. PTAB
`
`Consolidated Trial Practice Guide (November 2019), 73-75 (citing 37 C.F.R.
`
`§ 42.23(b)); Intelligent Bio-Sys., Inc. v. Illumina Cambridge, Ltd., 821 F.3d 1359,
`
`1369-70 (Fed. Cir. 2016) (“It is of the utmost importance that petitioners in the IPR
`
`proceedings adhere to the requirement that the initial petition identify ‘with
`
`particularity’ the ‘evidence that supports the grounds for the challenge to each
`
`claim.’” (quoting 35 U.S.C. § 312(a)(3)). Teleflex was not allowed an opportunity
`
`to submit rebuttal evidence in response to Petitioner’s new argument. Petitioner’s
`
`new argument and evidence are untimely and should be disregarded.
`
`C.
`
`Petitioner’s New Inherency Argument Is Unpersuasive, Even If
`the Board Were to Consider It
`
`
`Petitioner’s new evidence purports to show stents that “were insertable
`
`through an opening of 0.046 inches” based on the “crossing profile” or “crimped
`
`diameter” of the identified stents. Reply, 6 (citing Ex-1806 ¶¶47-52). But
`
`Petitioner and its new engineering expert ignore that its own evidence shows that
`
`
`least in part on inventor testimony regarding how the inventor came up with the
`
`invention (id., 39:15-40:4), which should not be part of an obviousness
`
`analysis. Jones’ entire role is an exercise in pure hindsight, and his testimony (Ex-
`
`1807) should be disregarded.
`
`9
`
`

`

`the newly-disclosed stents still require a minimum guiding catheter inner diameter
`
`of 5 French (which is 0.056”)—far larger than Itou’s effective 0.046” proximal
`
`opening. E.g. Ex-1802, 25 (specifying the “[m]inimal internal diameter of guiding
`
`catheter” for the 0.038” Tsunami stent is “0.056 inch, 5 Fr”), 7-8 (Genic stent with
`
`a crimped profile of 0.9 mm (0.035 inches) is “compatible with a 5 Fr guiding
`
`catheter”); Ex-1804 at 2, Table 2 (BxSonic stent with a crossing profile of 0.042”
`
`is “compatible with the 5F guiding catheter”).
`
`Neither Petitioner nor its expert explain why a POSITA would expect these
`
`stents to be insertable into Itou’s suction catheter, when the same exhibits state
`
`that those same stents require guiding catheters with minimum inner diameters of
`
`0.056”/5 French. In fact, Petitioner’s expert admitted that he did not know whether
`
`stents could navigate the transition into the lumen of Itou’s suction catheter, given
`
`its raised profile pushwire design. Ex-2239, 66:1-12, 67:15-68:13 (“I would have
`
`to test to determine what the maximum size that would pass through into the
`
`opening.”). Petitioner’s new stent evidence is not only untimely, it does not
`
`establish inherency.
`
`
`
`Teleflex’s expert, Mr. Keith, explained that having a stent crossing profile
`
`smaller than an opening does not mean that the stent is necessarily insertable. Ex-
`
`1805, 140:1-141:21. Petitioner characterizes this testimony as “questionable, as
`
`the 5 French version of GuideLiner v.3 also has an ID of 0.046 inches and is
`
`10
`
`

`

`marketed for delivering stents.” Reply, 8. But of course, GuideLiner V3 is not
`
`Itou and it has different structure; Petitioner does not even do the comparison. As
`
`Petitioner’s own expert explained, Itou’s raised pushwire structure creates a
`
`stepped or “offset” opening at the proximal opening of the suction catheter. Ex-
`
`2239, 66:1-7.
`
`IV. Dependent Claims 3, 13, and 14 (Grounds 1 and 2)
`
`A.
`
`Petitioner Failed to Show that Itou Anticipates Claims 3, 13,2 or
`14 (GROUND 1)
`
`
`In Reply, Petitioner tries to save its deficient anticipation evidence by
`
`making a legally erroneous “burden shifting” argument. Reply, 9-10. The Federal
`
`Circuit has rejected such burden shifting in IPRs. In re Magnum Oil Tools Int'l,
`
`Ltd., 829 F.3d 1364, 1375 (Fed. Cir. 2016). Petitioner’s Mytee case states only that
`
`during examination of a pending application, an examiner can shift the burden to
`
`the applicant to show non-inherency of a functionally-defined limitation. Mytee
`
`Prods., Inc. v. Harris Rsch, Inc., 439 F. App’x 882, 886 (Fed. Cir. 2011). Mytee
`
`expressly states that this burden-shifting presumption does not apply to issued
`
`patents. Id. Petitioner’s failure to argue or submit evidence to support inherency
`
`with its Petition is fatal to Ground 1 for all claims.
`
`
`2 Petitioner does not make a separate anticipation (Ground 1) argument about claim
`
`13. See Reply, 14.
`
`11
`
`

`

`Petitioner then cites back to its new inherency argument for claims 1 and 11,
`
`contending Itou “necessarily accommodates the insertion of a guidewire, balloon,
`
`stent and stent catheter.” Reply, 10. For the same reasons explained above, the
`
`Board should not credit this argument.
`
`Finally, Petitioner argues that after Itou’s protective catheter 5 is withdrawn
`
`from the suction catheter, a physician “may wish to reinsert it.” Reply, 10. This
`
`argument fails. First, that is undisputedly not disclosed by Itou and, therefore,
`
`cannot support anticipation. In fact, Itou expressly states that suction catheter 2
`
`may be pushed further into the vasculature after protective catheter 5 is removed,
`
`which is counter to Petitioner’s argument. Ex-1007, 7:19-23. Second, the
`
`protective catheter is not an interventional cardiology device, as explained above.
`
`Third, Teleflex has not had the opportunity to put in evidence showing why this
`
`new and untimely argument does not make sense.
`
`Petitioner’s contention that the “order of insertion” was “not inventive”
`
`(Reply, 10) misrepresents the testimony of inventor Mr. Root. Root testified it was
`
`part of the invention. Ex-1115, 165:11-15 (“[T]hat’s part of the invention.”). Root
`
`then simply stated that he did not consider it a separate invention. Id., 165:16-21
`
`(“It’s certainly part of the way you deliver this new device, so it’s part of the
`
`invention that way.”). Merely because one of the inventors stated that something is
`
`12
`
`

`

`not its own separate invention does not absolve Petitioner of its burden to show
`
`that the prior art meets the limitations of the claims. Petitioner has not done so.
`
`B. Claim 3 Would Not Have Been Obvious in View of Itou and
`Ressemann (GROUND 2)
`
`
`The issue is not simply whether Itou and Ressemann are analogous art, as
`
`Petitioner contends. See Reply, 11-12. There still must be sufficient motivation to
`
`modify one in view of the other. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 418-
`
`19 (2007). Itou and Ressemann are designed for different procedures and function
`
`in different ways. POR, 27-31; Ex-2138, ¶¶154-59; Ex-2145, ¶¶183-87.
`
`Concluding that both are in the same field of endeavor does not show sufficient
`
`motivation to combine with a reasonable expectation of success.
`
`Ressemann did disclose inserting interventional cardiology devices like
`
`stents, but it was an embolic protection device, specifically designed to catch loose
`
`emboli dislodged by the stent. Itou, on the other hand, is not an embolic protection
`
`device. Teleflex showed that inserting an interventional cardiology device down
`
`Itou’s suction catheter posed a “real risk” of pushing smaller residual thrombotic
`
`material out into the bloodstream. POR, 30. Petitioner’s own cardiologist expert
`
`agreed this is “a potential risk”. Ex-2240, 14:24-15:13. Itou’s suction catheter,
`
`unlike Ressemann’s embolic protection device, did not stop blood flow and had no
`
`mechanism for mitigating these smaller dislodged emboli. Petitioner has not
`
`shown that just because Ressemann’s embolic protection device was designed to
`
`13
`
`

`

`safely pass stents, a POSITA would have been motivated to configure Itou’s
`
`suction catheter to receive a stent.
`
`Petitioner contends that a POSITA would be motivated to modify Itou to
`
`meet claim 3’s limitations because Itou’s suction catheter is “precisely the right
`
`size for delivering angioplasty or stent catheters” and “[t]here is no meaningful
`
`structural difference between the claims and Itou.” Reply, 12. As explained
`
`above, this is wrong. Itou’s raised profile pushwire effectively blocks a substantial
`
`portion of the proximal opening such that it is smaller than the minimum required
`
`for stents. Supra, § II.C. Itou’s raised profile pushwire is not an issue for a suction
`
`catheter such as Itou that sucks soft thrombus distally-to-proximally. In fact, Itou’s
`
`robust pushwire is important to its disclosed functions—Itou explains that it is
`
`intended that the operator be able to rotate the pushwire, and thereby rotate the
`
`distal end suction tube. Ex-1007, 2:19-21, 7:20-24 (“the suction catheter 2 is
`
`operated so as to be rotated”). Petitioner’s experts agree that the ability to rotate
`
`Itou’s suction catheter using its pushwire is important to its function. Ex-2239,
`
`43:16-19 (“yes, I believe it’s important that Itou be able to rotate”); Ex-2238,
`
`151:5-14.
`
`Petitioner also contends that the patented GuideLiner product “grew from”
`
`VSI’s prior work on suction catheters. Reply, 13. Even if true, this would be
`
`legally irrelevant. 35 U.S.C. § 103 (“Patentability shall not be negated by the
`
`14
`
`

`

`manner in which the invention was made.”). And it is not true. The cited
`
`testimony merely states that VSI contemplated using reinforced polymer tubing
`
`similar to that used in its Pronto aspiration catheter for the distal tubular section of
`
`GuideLiner. Ex-1762, 44:22-47:1.
`
`C. Claim 13 Would Not Have Been Obvious in View of Itou and
`Ressemann (GROUND 2)
`
`
`Petitioner attempts to fault Teleflex for purportedly requiring “bodily
`
`incorpora[ion].” Reply, 15-16. But it was Petitioner who argued in the Petition
`
`that “a POSITA would be motivated to replace Itou’s proximal tip (23) with the
`
`support collar disclosed in Ressemann.” Petition, 73 (emphasis added). Teleflex
`
`merely responded, pointing out that Petitioner did not adequately explain how a
`
`POSITA would expect to be able to successfully do that. POR, 37-38. Petitioner
`
`now tries to recast its argument as “modifying Itou with the shape of the
`
`Ressemann collar” (Reply, 14), but even its new expert confirmed that the proposal
`
`was to “remove Itou’s collar and replace it with Ressemann’s collar.” Ex-2239,
`
`167:18-168:1.
`
`Petitioner also incorrectly contends that its experts “are uniformly clear that
`
`the particular construction of Ressemann’s embodiment 2100 is not what they rely
`
`upon.” Reply, 16. Petitioner’s original engineering expert supported his opinion
`
`by asserting that Ressemann teaches to “rest tab portion 2141b adjacent the
`
`exterior of [Itou’s] wire-like portion 25.” Ex-1042, ¶106. That is not the case—
`
`15
`
`

`

`everyone now agrees that Ressmann teaches to place tab portion inside a shaft
`
`2120 and underneath the core wire 2135. Ex-1008, 27:51-67.
`
`Petitioner’s Reply also completely ignores the fundamental flaw in
`
`Petitioner’s proposed combination: that a POSITA would not be motivated to
`
`myopically fixate on Ressemann’s support collar in the first place, absent
`
`hindsight. POR, 34-37. Petitioner went so far as to prevent its new engineering
`
`expert from even considering how Ressemann’s support collar is used in
`
`Ressemann itself. Ex-1807, ¶82. In Ressemann, the support collar is merely one
`
`structural component buried within a complex embolic protection device. A
`
`POSITA would not be motivated to extract this lone component from the complex
`
`evacuation sheath assembly (in which it does not provide a concave track or
`
`perform any guiding function) and use it to form the proximal opening in Itou’s
`
`structurally and functionally different suction catheter unless he/she was using
`
`claim 13 as a roadmap. Petitioner’s engineering expert admitted to using a
`
`hindsight-focused approach when considering Ressemann. Ex-2137, 132:15-
`
`133:11 (“I'm not overly concerned with what the collar was being done before I
`
`chose to use it. . . . I’m more concerned about how I can use it in combination for
`
`what I want to do”); see also Ex-2116, 239:7-13.
`
`16
`
`

`

`D. Claim 14 Is Not Obvious in View of Itou and Ressemann
`(GROUND 2)
`
`Petitioner does not make any separate arguments about claim 14. Reply, 10-
`
`13. Petitioner has failed to show that claim 14 is obvious for the same reasons it
`
`failed to show claim 3 obvious. Supra, § III.B.
`
`V. Dependent Claim 6 (GROUND 1): Itou Does Not Anticipate Because Its
`Distal Tip Portion Is Not Cylindrical
`
`In an attempt to circumvent the clear claim language requiring “a flexible
`
`cylindrical distal tip portion,” Petitioner repeatedly emphasizes the word
`
`“includes.” Reply, 13-14. But this is a red herring—the claim requires that the
`
`tubular structure “includes a flexible cylindrical distal tip portion.” The plain
`
`meaning of this term requires that the flexible distal tip portion is cylindrical, not
`
`merely that it include a cylindrical portion. Itou’s distal sharply angled distal tip
`
`portion is not cylindrical.
`
`This makes sense, given the different purposes of Itou and the invention of
`
`claim 6. Itou is intended to suction thrombus, and the distal tip portion of its
`
`tubular structure “has a shape inclined obliquely . . . to increase the area of the inlet
`
`opening . . . to facilitate suction of a foreign matter . . . [and also] advance easily
`
`between the foreign matter and the inner wall of the blood vessel.” Ex-1007, 4:4-
`
`10. The distal tip portion of the claimed tubular structure, in contrast, is intended
`
`to deliver interventional cardiology devices and therefore must be “cylindrical.”
`
`17
`
`

`

`Petitioner has not shown that Itou’s suction catheter with its obliquely angled distal
`
`tip portion anticipates claim 6.
`
`VI. Petitioner Has Not Refuted the Striking Objective Evidence that
`Confirms Claims 3 and 13 Were Not Obvious
`
`Petitioner does not dispute that GuideLiner was an incredibly successful
`
`category-creating product or that the nexus requirement is met. Reply, 16-22.
`
`Instead, Petitioner argues that GuideLiner’s remarkable successes should be
`
`disregarded because the claimed elements individually were known in the art and it
`
`would have been obvious to combine them. Id. at 16-17. But this ignores the very
`
`purpose of objective evidence: to act as a real-world check against the tendency
`
`towards hindsight. The Board should reject Petitioner’s flawed and unpersuasive
`
`attempt to sidestep the compelling objective evidence.
`
`A.
`
`The Objective Evidence, Including Nexus, Is Undisputed
`
`
`
`Petitioner does not dispute any