UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`v.
`ETHICON LLC,
`Patent Owner
`
`IPR2018-01247
`U.S. Patent No. 8,479,969
`
`
`
`
`
`PATENT OWNER’S PRELIMINARY RESPONSE
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`
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`
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`

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`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
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`Page
`
`INTRODUCTION .......................................................................................... 1
`
`STATUTORY DISCLAIMER ........................................................................ 4
`
`III. THE 969 PATENT .......................................................................................... 5
`
`A. Overview ............................................................................................... 5
`
`B.
`
`Priority Date ........................................................................................ 11
`
`IV. CLAIM CONSTRUCTION .......................................................................... 11
`
`V.
`
`THE PRIOR ART .......................................................................................... 12
`
`A. Anderson ............................................................................................. 12
`
`B.
`
`Timm ................................................................................................... 15
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`C. Wallace ................................................................................................ 19
`
`D. Knodel ................................................................................................. 20
`
`E.
`
`Viola .................................................................................................... 22
`
`VI. REASONS WHY THE PETITION SHOULD BE DENIED ....................... 24
`
`A. Ground 1 Should Be Denied Pursuant To 37 C.F.R. § 42.107(e)....... 24
`
`B.
`
`Grounds 2-5 Should be Denied Because Petitioner Does Not
`Establish A Motivation To Combine Or Reasonable Expectation
`of Success ............................................................................................ 25
`
`1.
`
`2.
`
`Ground 2: Petitioner provides no explanation for how to
`combine the incompatible systems of Anderson and Timm
` ................................................................................................... 26
`
`Ground 3: Petitioner provides no explanation for how to
`combine the incompatible systems of Anderson, Timm,
`and Wallace ............................................................................... 32
`i
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`

`

`3.
`
`4.
`
`5.
`
`Grounds 4 and 5: Petitioner provides no explanation for
`how to combine the incompatible systems of Anderson,
`Knodel and Viola ...................................................................... 35
`
`Petitioner’s proposed combinations fundamentally change
`the principle of operation of Anderson ..................................... 37
`
`Petitioner fails to show a reasonable expectation of
`success ....................................................................................... 38
`
`VII. CONCLUSION .............................................................................................. 43
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`ii
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`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Agrinomix, LLC v. Mitchell Ellis Prods., Inc.,
`IPR2017-00525, Paper No. 6 (P.T.A.B. June 14, 2017) .................................... 41
`Arctic Cat Inc. v. Bombardier Recreational Prod. Inc.,
`876 F.3d 1350 (Fed. Cir. 2017) ...................................................................... 4, 25
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (P.T.A.B. Dec. 15, 2017) ........................................... 40
`Compass Bank v. Intellectual Ventures II,
`IPR2014-00786, Paper 46 (P.T.A.B. Sept. 23, 2015)................................... 32, 39
`Corning Inc. v. DSM IP Assets,
`IPR2013-00050, Paper 77 (P.T.A.B. May 1, 2014) ....................................... 32, 9
`Cultec, Inc. v. Stormtech Inc.,
`IPR2017-00777, Paper No. 7 (P.T.A.B. Aug. 22, 2017) .................................... 42
`Institut Pasteur v. Focarino,
`738 F.3d 1337 (Fed. Cir. 2013) .......................................................................... 26
`Kinetic Concepts Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) .......................................................................... 25
`Plas-Pak Indus. v. Sulzer MixPac AG,
`600 F. App’x 755 (Fed. Cir. 2015) ..................................................................... 37
`Praxair Distrib., Inc. v. INO Therapeutic LLC,
`IPR2015-00893, Paper 14 (P.T.A.B. Sept. 22, 2015)......................................... 40
`In re Ratti,
`270 F.2d 810 (C.C.P.A. 1959) ............................................................................ 37
`Unified Patents Inc. v. Berman,
`IPR2016-01571, Paper No. 10 (P.T.A.B. Dec. 14, 2016) .................................. 43
`
`iii
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`

`

`Vectra Fitness, Inc. v. TNWK Corp.,
`162 F.3d 1379 (Fed. Cir. 1998) ............................................................................ 4
`Statutes
`35 U.S.C. § 253(a) ..................................................................................................... 4
`Other Authorities
`37 C.F.R. § 1.321(a) ................................................................................................... 4
`37 C.F.R. § 42.65(a) ........................................................................................... 32, 39
`37 C.F.R. § 42.100(b) ................................................................................................ 2
`37 C.F.R. § 42.107(e) ........................................................................................... 5, 24
`37 CFR § 42.6(a)(2)(ii) ............................................................................................ 45
`37 CFR § 42.6(a)(2)(iii) ........................................................................................... 45
`37 CFR § 42.8 .......................................................................................................... 45
`37 CFR § 42.24(a)(1)(i) ........................................................................................... 45
`77 Fed. Reg. 48,756 (Aug. 14, 2012)....................................................................... 12
`83 Fed. Reg. 51,340 (Oct. 11, 2018) ........................................................................ 12
`
`
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`
`
`
`iv
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`

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`EXHIBIT LIST
`
`Exhibit #
`
`2001
`
`2002
`2003
`
`Description
`Excerpts of a technology tutorial filed in Ethicon v. Intuitive
`Surgical, C.A. No. 1-17:cv-871 (LPS) (CJB) (D. Del. June 28,
`2018)
`Patent Statutory Disclaimer for U.S. Patent No. 8,479,969 filed on
`October 15, 2018
`U.S. Patent No. 7,524,320
`
`
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`v
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`

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`I.
`
`INTRODUCTION
`Ethicon is a market leader in developing endocutter1 technology and
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`commercially released its first endocutter in 1996. Since then, Ethicon has
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`developed numerous endocutters to address changing surgical needs. In 2011,
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`Ethicon introduced its first motor-powered endocutter – the ECHELON FLEX™
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`Powered ENDOPATH® Stapler. Ethicon’s motor-powered endocutters offer
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`numerous benefits including dramatically reducing the force required to operate an
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`endocutter and providing reliability across a broad range of tissue thicknesses.
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`The challenged claims of U.S. Patent No. 8,479,969 (“the 969 Patent”) are
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`directed to an articulating endocutter surgical tool that operatively couples to a robot
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`surgical system. More specifically, the 969 Patent improves upon prior robotic
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`surgical tools, such as an ultrasound probe, that were known to be “unable to
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`generate the magnitude of forces required to effectively cut and fasten tissue” as is
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`required of an endocutter. Ex. 1001, 23:6-29. The 969 Patent’s innovative tool base
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`for an endocutter overcame these limitations of the prior art systems.
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`
`1 An endocutter is a surgical instrument that both staples and cuts tissue. The term
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`“stapler” can also be used to refer to this type of device, but can also refer to a device
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`that only staples. Exhibit 2001 includes excerpts of a technology tutorial on
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`endocutters that was filed in the District of Delaware on June 28, 2018.
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`1
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`

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`
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`Petitioner’s obviousness challenge is based on U.S. Patent No. 6,783,524
`
`(“Anderson”), a patent issued in 2004 that is assigned to Petitioner. Anderson
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`discloses an ultrasound probe with an end effector and a rotating shaft. While
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`Anderson’s ultrasound probe can cut and cauterize tissue using ultrasound energy, it
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`cannot cut and fasten through mechanical means such as a cutting blade or surgical
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`staples. Indeed, consistent with this lack of mechanical cutting capability, the 969
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`Patent specification discloses Anderson as an example of a prior art robotic surgery
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`system, and notes that many of such systems “have in the past been unable to
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`generate the magnitude of forces required to effectively cut and fasten tissue.” Ex.
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`1001, 23:6-29.
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`Anderson’s instrument couples to a robotic system through a comparatively
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`rudimentary tool base that controls the shaft rotation and end effector. In order to
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`arrive at the more sophisticated instruments claimed by the 969 Patent, Petitioner
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`proposes to combine Anderson with aspects of various handheld surgical
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`instruments disclosed in U.S. Patent Nos. 7,510,107 (“Timm”), 6,699,235
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`(“Wallace”), 5,465,895 (“Knodel”), and 5,954,259 (“Viola”). As Petitioner admits,
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`all of these secondary references were made of record during prosecution.
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`Petitioner’s obviousness grounds, however, fail to satisfy the basic standard
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`for establishing obviousness. Petitioner does not explain how Anderson’s tool base
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`could be adapted to preserve the functionality of Anderson’s probe while also
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`2
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`

`

`
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`supporting the additional functionalities that Petitioner proposes to incorporate from
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`Timm, Wallace, Knodel, and Viola. Indeed, as shown in the figures below, it is
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`apparent that combining the handheld endocutter systems of Timm, Knodel, and
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`Viola and the non-endocutter robotic tool of Anderson is not a simple matter of
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`taking the endocutter end effector from Timm and attaching it to the robotic tool
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`base of Anderson. Petitioner’s combination is pure hindsight because it wholly
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`neglects the more complex drive system required for an endocutter as compared to
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`the non-endocutter tool of Anderson, as well as the significant difference in a drive
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`system for a handheld tool versus a robotic tool.
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`
`
`Timm
`(Handheld Endocutter)
`
`Anderson
`(Robotic Ultrasound Probe)
`
`End
`effector
`
`Drive
`System
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`3
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`
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`Additionally, Petitioner fails to offer any evidence of reasonable expectation
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`of success in the combination of any of the references. This failure alone is grounds
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`to deny institution. See Arctic Cat Inc. v. Bombardier Recreational Prod. Inc., 876
`
`F.3d 1350, 1360-61 (Fed. Cir. 2017) (“where a party argues a skilled artisan would
`
`have been motivated to combine references, it must show the artisan would have had
`
`a reasonable expectation of success from doing so”) (internal citation and quotation
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`omitted).2
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`For these reasons, and the additional reasons explained in detail below, Patent
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`Owner respectfully requests that the Board deny institution as to all grounds asserted
`
`in the petition.
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`II.
`
`STATUTORY DISCLAIMER
`On October 15, 2018, Ethicon filed with the U.S. Patent and Trademark Office
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`a statutory disclaimer of claim 23 of the 969 Patent under 35 U.S.C. § 253(a) and 37
`
`C.F.R. § 1.321(a). A copy of the statutory disclaimer is submitted as Exhibit 2002
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`in this proceeding. Based on this disclaimer, the 969 Patent is to be treated as though
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`claim 23 never existed. Vectra Fitness, Inc. v. TNWK Corp., 162 F.3d 1379, 1383
`
`(Fed. Cir. 1998) (“This court has interpreted the term ‘considered as part of the
`
`original patent’ in section 253 to mean that the patent is treated as though the
`
`
`2 All emphasis added unless otherwise noted.
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`4
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`

`

`
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`disclaimed claims never existed.”). As a result of the statutory disclaimer of claim
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`23, and pursuant to 37 C.F.R. § 42.107(e), it is respectfully submitted that the
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`institution decision in this proceeding should be based only on the remaining
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`challenged claims—19-22 and 24-26—of the 969 Patent.
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`III. THE 969 PATENT
`A. Overview
`The challenged claims of the 969 Patent are directed to novel implementations
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`of a “surgical tool for use with a robotic system.” The surgical tool of independent
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`claim 24 includes, inter alia, a transmission assembly in meshing engagement with
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`a gear-driven portion to apply control motions to a selectively moveable component
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`of the end effector, as well as an elongated shaft comprising proximal and distal
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`spine portions coupled at an articulation joint to facilitate articulation of the end
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`effector. Ex. 1001, claim 24. The surgical cutting and stapling tool of independent
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`claims 19 and 21 includes, inter alia, a transmission assembly in meshing
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`engagement with a gear-driven portion to apply control motions to a cutting
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`instrument axially movable within the end effector. Id., claims 19, 21.
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`The claimed surgical tools each include “a tool mounting portion operably
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`coupled to” the instrument shaft that is “configured to operably interface with the
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`tool drive assembly” of the robotic system in order to apply control motions to
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`various components of the instrument, such as the cutting blade or the selectively
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`5
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`movable end effector. Id., claim 21. An endocutter embodiment of the 969 Patent
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`is depicted in Figure 132:
`
`Ex. 1001, Fig. 132
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`
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`The instrument includes an endocutter end effector (6012) that has a movable
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`upper jaw/anvil (6024) that moves between first and second positions relative to the
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`lower jaw (6022). Id., 77:7-13. The endocutter end effector also includes a cutting
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`instrument that moves between first and second positions relative to the lower jaw
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`(6022). Id., 84:27-37. The end effector 6012 is located on one end of the elongated
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`shaft (6008), which has an articulation joint (6100). Id., 76:62-67. The articulation
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`joint 6100 allows the shaft to selectively articulate on two axes, one that is transverse
`6
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`
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`to the longitudinal tool axis (designated “LT”), and one that is transverse to both the
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`first articulation axis and LT. Id., 77:38-46. These axes are designated “TA1” and
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`“TA2” in Figure 133, which provides a more detailed view of the articulation joint
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`6100:
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`Ex. 1001, Fig. 133
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`
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`The instrument couples to the surgical system via the tool mounting portion
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`(6200). Id., 77:1-2. Figure 136 below shows the tool mounting portion 6200 in
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`detail. The tool mounting portion includes an articulation transmission system
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`(6142) that controls articulation about the articulation joint 6100. Id., 78:23-34. The
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`7
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`
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`robotic system controls the articulation transmission system by applying a first
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`rotary output motion to the articulation drive gear (6322). Id., 81:28-82:19.
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`Ex. 1001, Fig. 136
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`
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`The tool mounting portion includes closure transmission (6512) including a
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`closure gear assembly (6520) to close the anvil 6420 of the endocutter in response
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`to a third rotary output motion from the robotic system to the closure spur gear
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`(6522). Id., 83:44-84:26.
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`The tool mounting portion additionally includes a knife drive transmission
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`portion (6550) including a knife gear assembly (6560) to fire the cutting instrument
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`8
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`to cut tissue in response to a fourth rotary output motion from the robotic system to
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`the knife spur gear (6562). Id., 84:38-85:16.
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`The tool mounting portion also includes a rotational transmission assembly
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`(6400) that imparts rotary control motion for rotating the instrument shaft about the
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`longitudinal axis LT-LT. Id., 82:42-51. The robotic system controls the rotational
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`transmission assembly by applying a second rotary output motion to the rotation
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`drive gear (6412). Id., 83:8-15.
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`Thus, as discussed above and described in detail by the 969 Patent, the
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`“unique and novel transmission arrangement” of the 969 Patent allows a robotic
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`system with four output motions to control (i) articulation about two different
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`articulation axes that are substantially transverse to each other and the longitudinal
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`tool axis: (ii) end effector rotation about the longitudinal tool axis; (iii)
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`opening/closing of the end effector anvil to clamp tissue; and (iv) firing the cutting
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`instrument to cut tissue. Id., 85:19-32. As noted in the 969 Patent, “[t]he unique and
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`novel shifter arrangements . . . enable two different articulation actions to be
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`powered from a single rotatable body portion of the robotic system.” Id., 85:32-36.
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`Unlike prior art robotic tool mounts, such as those of Anderson’s system, which were
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`“unable to generate the magnitude of forces required to effectively cut and fasten
`
`tissue,” the gears of the 969 Patent’s embodiments were further sized to generate the
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`9
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`

`

`
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`necessary force to close the anvil and cut and staple tissue. Id., 23:6-29, 84:20-26,
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`85:4-10.
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`Petitioner devotes several pages of the Petition to alleging that the 969 Patent
`
`copied Petitioner’s Anderson patent, which, as discussed below, is also the primary
`
`reference in all of Petitioner’s proposed grounds of invalidity. Petition at 1-3.
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`Petitioner’s insinuations, however, misrepresent the contributions of the 969 Patent.
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`As an initial matter, the 969 Patent does not purport to have invented robotic surgical
`
`systems; indeed, the 969 Patent specification expressly discloses examples of known
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`prior art robotic systems and robotic tools, including Anderson. Ex. 1001, 23:6-29.
`
`Thus, the inclusion of figures 23 and 25 depicting known robotic systems is of no
`
`moment, and provides the appropriate context for the invention.
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`Importantly, the 969 Patent further discloses that these systems were known
`
`to be “unable to generate the magnitude of forces required to effectively cut and
`
`fasten tissue.” Id. As discussed above, the 969 Patent’s innovative tool base
`
`overcame these limitations of the prior art systems. Moreover, as discussed in
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`greater detail below, Anderson discloses a tool base for an ultrasound probe, not an
`
`endocutter. Ex. 1010, Abstract. Unlike an endocutter, an ultrasound probe does not
`
`use a mechanical cutting component to cut tissue or staples to close tissue. Rather,
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`it severs and cauterizes tissue by applying ultrasound energy. Because of this
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`difference, Anderson’s instrument need control only two functions—opening and
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`10
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`

`
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`closing the end effector jaws and rotating the shaft—which it does using three of
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`four rotary outputs from the robotic system. Id., 16:45-17:9. The 969 Patent, by
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`contrast, discloses a novel instrument base that allows a robotic system, using only
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`four rotary outputs, to control an endocutter that grasps tissue in the end effector,
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`cuts and staples tissue, articulates about an articulation joint, and rotates about a
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`longitudinal axis. Ex. 1001, 85:17-36. The Petition’s allegations of copying wholly
`
`ignore the significant advancements described and claimed in the 969 Patent as
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`compared to the surgical tool disclosed in Anderson.
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`Priority Date
`B.
`Petitioner contends that the challenged claims of the 969 Patent are not
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`entitled to a priority date earlier than May 27, 2011. Petition at 9-10. The 969 Patent
`
`claims priority to application No. 11/651,807, which was filed on Jan. 10, 2007. Ex.
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`1001, (63). Because the Petition should be denied, for the reasons set forth herein,
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`regardless of the effective filing date of the challenged claims, Patent Owner does
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`not address Petitioner’s priority date arguments herein, but reserves all rights to
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`subsequently contend in any instituted IPR or in any other proceeding that the
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`challenged claims are entitled to their earliest claimed effective filing date.
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`IV. CLAIM CONSTRUCTION
`For purposes of IPR only, the claims of the 969 Patent should be construed
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`using the broadest reasonable construction in light of the specification of the patent.
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`11
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`
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`See Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012);
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`37 C.F.R. § 42.100(b)3.
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`V. THE PRIOR ART
`A. Anderson
`Anderson is directed to a robotic surgical tool with an ultrasound cutting and
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`cauterizing end effector. Ex. 1010, Abstract. Anderson states that robotic surgery
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`systems allegedly addressed some of the disadvantages of traditional endoscopic
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`surgical instruments, such as the “lack of intuitiveness, dexterity and sensitivity of
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`endoscopic tools.” Id., 2:16-40. Anderson also describes advantages of ultrasound
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`surgical tools, such as “reduced collateral tissue damages, reduced risk of unwanted
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`burns, and the like.” Id., 3:45-53. According to Anderson, however, ultrasound
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`instruments for use with robotic surgical systems were not readily available. Id.,
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`3:53-55. Thus, Anderson is directed to “providing ultrasound energy via a robotic
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`surgical instrument for use with a robotic surgical system,” in order to “enable the
`
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`3 Patent Owner recognizes that the USPTO has issued a final rule revising the claim
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`construction standard for IPR proceedings filed on or after November 13, 2018. See
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`83 Fed. Reg. 51,340 (Oct. 11, 2018). Because Petitioner filed its Petition on June
`
`14, 2018, the broadest reasonable interpretation standard should apply to this IPR
`
`pursuant to pre-October 11, 2018 37 C.F.R. § 42.100(b).
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`12
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`
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`advantages associated with ultrasound to be combined with the advantages of
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`minimally invasive robotic surgery.” Id., 4:7-11.
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`Anderson’s ultrasound instrument is shown in Figure 2.
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`Ex. 1010, Fig. 2
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`
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`The instrument includes a shaft 28.1 that can rotate as indicated by the arrows labeled
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`E. Ex. 1010, 11:43-46. In some embodiments, the end effector 38 also includes a
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`gripping jaw, labeled 82 in Figure 10:
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`
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`Ex. 1010, Fig. 10
`13
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`
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`The instrument attaches to the robotic system through the instrument base 34. Id.,
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`11:66-12:11.
`
`Figure 13, reproduced below, illustrates Anderson’s instrument base in greater
`
`detail. The instrument base includes a roll spool 94, an actuator spool 95, an idler
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`spool 95b, and an unlabeled spool position (located opposite the actuator spool 95).
`
`Roll cable 101 spans between roll spool 94 and a roll drum 96, and these three
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`components work together to control the rotation of the instrument shaft. Ex. 1010,
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`16:45-61. Actuator spool 95 and idler spool 95b are connected by cable loop 102,
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`and together these components control the gripper 82 of the end effector. Id., 16:62-
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`17:9. The unlabeled spool opposite actuator spool 95 is unused.
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`
`
`Ex. 1010, Fig. 13
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`14
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`

`

`
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`Thus, the Anderson instrument base utilizes three rotary output motions (roll spool
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`94, actuator spool 95, and idler spool 95b) to control two instrument motions (shaft
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`rotation and gripper open/close), with one additional rotary output available for
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`additional control.
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`Anderson was cited in the specification of the 969 Patent, as an example of
`
`prior art robotic systems that “have in the past been unable to generate the magnitude
`
`of forces required to effectively cut and fasten tissue.” Ex. 1001, 23:6-29.
`
`Timm
`B.
`Timm is a patent assigned to Patent Owner that discloses a handheld
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`endocutter with a cable drive system. Ex. 1011, Abstract; Fig. 1. According to
`
`Timm, prior art cable-driven surgical instruments “suffer[ed] from a low mechanical
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`advantage and tend[ed] to require relatively high forces to pull the knife through its
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`stroke.” Id., 2:7-9. Additionally, such instruments purportedly “may suffer from
`
`the inadvertent disengagement of the cable from the pulley system which may
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`disable the device.” Id., 2:12-14. The improvement disclosed by Timm is an
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`instrument with a “cable transition support” and a “cable retention arrangement for
`
`retaining the drive cable around at least a portion of the cable transition support.”
`
`Id., 2:25-55. Timm’s instrument is depicted in Figure 1:
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`15
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`
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`Ex. 1011, Fig. 1
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`
`
`As shown above, the instrument includes a shaft 20 that comprises a distal end
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`20a, attachment mechanism 20b, and shaft connector portion 20c. Ex. 1011, 7:49-
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`58. The surgeon can rotate the shaft by manually turning the knob K. Id., 9:4-5.
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`Shaft connector portion 20c connects to a disposable loading unit (DLU) 10 through
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`the connector mechanism C. Id., 7:55-58. DLU 10 comprises a tool assembly 100
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`that includes an elongated channel assembly 120, an anvil assembly 110, and a staple
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`cartridge assembly 200 placed inside the elongated channel. Id., 8:3-16. The tool
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`assembly further includes a “dynamic clamping member” 150 that moves along the
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`length of the elongated channel to actuate the cutting mechanism. Id., 8:12-16, 10:1-
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`13. The surgeon operates the clamping and cutting mechanism by pulling the firing
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`trigger on the device handle. Id., 14:39-15:67.
`16
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`A close-up of an exemplary embodiment of the connector mechanism C is
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`shown in Figure 52:
`
`Ex. 1011, Fig. 52
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`
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`As shown above, this implementation includes a ball-shaped member 2730
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`that fits into socket 2750 to form a ball joint, allowing articulation of the distal
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`portion of the shaft. Ex. 1011, 28:50-65. Timm describes that in some embodiments,
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`the articulation system further includes four articulating wires that the surgeon can
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`push or pull to articulate the distal portion of the shaft accordingly. Id., 37:55-38:8.
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`An embodiment of the device handle for such an implementation is shown in
`
`Figure 82:
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`17
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`
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`Ex. 1011, Fig. 82
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`
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`The handle includes an articulation knob 5620, which is part of a “joy stick
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`assembly” 5602. Id., 40:34-51. By grasping the hand grip portion 5512 in one hand
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`and manipulating the articulation knob 5620 with the other, the surgeon can apply
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`articulation motions to the articulation wires 5092 in order to articulate the distal
`
`portion of the spine while operating the device. Id., 40:52-63.
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`18
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`
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`C. Wallace
`Wallace is directed to a robotic surgical instrument with a “wrist mechanism”
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`that allows the end effector to articulate under the control of a series of rods. Ex.
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`1008, Abstract. Examples of the wrist mechanism are shown in Figures 2A and 3.
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`Ex. 1008, Figs. 2A and 3
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` Wallace’s instrument couples to a robotic system through a tool base 62,
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`shown in Figure 30. Id., 7:37-40. The articulation rods shown in Figures 2A and 3
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`emerge into the tool base as rods 300. Id., 13:44-45. Gears 400 rotate the sector
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`gears 312, which advances or retracts individual ones of the rods 300 to actuate the
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`wrist mechanism. Id., 13:47-54. Gear 420 rotates the roll pulley 310, which causes
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`the rods and the instrument shaft to rotate around the central axis of the shaft. Id.,
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`13:66-14:10. Thus, Wallace’s tool base utilizes three rotary output motions (those
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`of the two gears 400 and the one gear 420) to control two instrument motions (wrist
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`articulation and shaft rotation).
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`Ex. 1008, Fig. 30
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`D. Knodel
`Knodel is an expired patent directed to a handheld surgical stapler. Ex. 1012,
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`Abstract. As shown below in Figure 1, Knodel’s instrument comprises an endocutter
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`end effector on an elongated shaft coupled to a handle.
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`20
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`Ex. 1012, Fig. 1
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`As is relevant to Petitioner’s challenge, Knodel’s instrument includes a “drive
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`member” 164, shown in the exploded view of the distal end of the instrument in
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`Figure 2.
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`Ex. 1012, Fig. 2
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`When the firing mechanism of the device is actuated by pulling the firing
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`trigger 140, the drive member 164 and wedge work member 162 move distally along
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`the end effector, which causes staples to fire from the staple cartridge. Ex. 1012,
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`11:56-12:1. The distal movement of the wedge work member also causes the knife
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`member 161 to move distally, which severs the stapled tissue. Id., 12:1-6.
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`Knodel contains no disclosure regarding tools designed for robotic surgery
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`systems.
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`E. Viola
`Viola is an expired patent directed to a powered handheld endocutter. Ex.
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`1013, Abstract.
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`Ex. 1013, Fig. 1
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`As is relevant to Petitioner’s challenges, Viola purportedly discloses an end
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`effector that is controlled via a rotary drive shaft (in the form of drive screw 78) that
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`is shown in Figure 5, an exploded view of Viola’s end effector:
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`23
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`Ex. 1013, Fig. 5
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`When the surgeon depresses trigger 44 on the handle of Viola’s device, a
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`motor assembly contained within the handle transfers rotational motion to the drive
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`screw 76 through a drive shaft 42, which drives an actuation beam 100 forward into
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`the channel of the endocutter, causing the anvil 86 to close and staples to fire from
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`the cartridge 90. Ex. 1013, 7:45-8:5.
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`Viola includes no disclosures regarding shaft articulation or tools designed for
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`robotic surgical systems.
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`VI. REASONS WHY THE PETITION SHOULD BE DENIED
`A. Ground 1 Should Be Denied Pursuant To 37 C.F.R. § 42.107(e)
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`24
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`Ground 1 of the Petition is directed solely to claim 23, which Patent Owner
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`has disclaimed. As such, Ground 1 should be denied institution.
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`B. Grounds 2-5 Should be Denied Because Petitioner Does Not
`Establish A Motivation To Combine Or Reasonable Expectation of
`Success
`All of the remaining asserted grounds are obviousness combinations. In an
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`obviousness ground, it is the Petitioner’s burden to show “that a skilled artisan would
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`have been motivated to combine the teachings of the prior art references to achieve
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`the claimed invention, and that the skilled artisan would have had a reasonable
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`expectation of success in doing so.” Kinetic Concepts Inc. v. Smith & Nephew, Inc.,
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`688 F.3d 1342, 1360 (Fed. Cir. 2012) (citation omitted). Petitioner falls far short of
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`meeting this burden for each of the remaining grounds.
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`First, Petitioner provides no explanation for how the robotic ultrasound tool
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`of Anderson and the handheld endocutter of Timm would be combined with each
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`other as proposed in Ground 2, much less with Wallace as proposed in Ground 3.
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`Second, Petitioner does not provide any evidence of a reasonable expectation
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`of success. The Federal Circuit has “held that where a party argues a skilled artisan
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`would have been motivated to combine references, it must show the artisan would
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`have had a reasonable expectation of success from doing so.” Arctic Cat Inc., 876
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`F.3d at 1360-61 (internal citation and quotations omitted). “[K]knowledge of the
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`goal does not render its achievement obvious, and obviousness generally requires
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`that a skilled artisan have reasonably expected success in achieving that goal.”
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`Institut Pasteur v. Focarino, 738 F.3d 1337, 1346 (Fed. Cir. 2013) (internal quotes
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`and cites omitted).
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`Petitioner mentions a reasonable expectation of success only in passing
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`quotations of obviousness rationales, providing no factual evidence or analysis to
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`support a reasonable expectation of success in any of the grounds. For this reason,
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`the Petition fails as a matter of law.
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`1. Ground 2: Petitioner provides no explanation for how to
`combine the incompatible systems of Anderson and Timm
`First, Petitioner has provided no cognizable combination of Anderson and
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`Timm to disclose the subject matter of claim 24.
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`With respect to limitation 24.2, which requires “a distal spine portion operably
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`coupled to said end effector; and a proximal spine portion pivotally coupled to said
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`distal spine portion at an articulation joint to facilitate articulation of said surgical
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`end effector about an articulation axis that is substantially tranverse to said
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`longitudinal tool axis,” (Ex. 1001, 95:48-54) Petitioner broadly contends that a
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`POSITA would have modified Anderson “to use Timm’s end effector with
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`Anderson” and “to include pivotally coupled distal and proximal spine portions (as
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`suggested by Timm).” Petition at 31, 38.
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`Petitioner’s cursory description does not logically follow from the disclosures
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`of Anderson and Timm. As discussed above in Section V.A., Anderson was directed
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`toward an ultrasound probe for use with a robotic surgical system. Ex. 1010,
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`Abstract. To that end, Anderson’s instrument attache