UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`v.
`ETHICON LLC,
`Patent Owner
`
`IPR2018-01248
`U.S. Patent No. 8,479,969
`
`
`
`
`
`PATENT OWNER’S RESPONSE
`
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`v.
`ETHICON LLC,
`Patent Owner
`
`IPR2018-01248
`U.S. Patent No. 8,479,969
`
`
`
`
`
`PATENT OWNER’S RESPONSE
`
`
`
`
`
`
`
`
`
`
`
`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
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`Page
`
`INTRODUCTION .......................................................................................... 1
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`THE 969 PATENT .......................................................................................... 4
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`III. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 10
`
`IV. CLAIM CONSTRUCTION .......................................................................... 11
`
`V.
`
`THE PRIOR ART .......................................................................................... 11
`
`A.
`
`Prisco ................................................................................................... 11
`
`1.
`
`2.
`
`Prisco Discloses Two Distinct Grip Mechanisms: Cable
`“Pull-Pull” and Drive Rod “Push-Pull” .................................... 15
`
`Prisco’s Shaft Roll Mechanism ................................................. 17
`
`B.
`
`Cooper ................................................................................................. 17
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`C. Wallace ................................................................................................ 21
`
`D.
`
`Tierney ................................................................................................. 22
`
`VI. THE CHALLENGED CLAIMS ARE PATENTABLE ............................... 22
`
`A. Ground 1: Prisco Does Not Disclose All Limitations Of Claim
`24 Arranged As In The Claim, And A POSITA Would Not Have
`At Once Envisaged Such An Arrangement ......................................... 23
`
`1.
`
`2.
`
`Prisco Does Not Disclose Combining the Drive Rod
`“Push-Pull” Embodiment With Cooper’s Articulating
`Wrist Mechanism ...................................................................... 26
`
`Petitioner’s Alternate Theory Relying On Shaft Roll Gear
`742 Does Not Disclose The Claimed Gear-Driven Portion
`In Operable Communication With A Selectively Movable
`Component And Associated Transmission Assembly .............. 31
`
`i
`
`
`
`B.
`
`Grounds 2-4: A POSITA Would Not Have Combined Prisco’s
`Drive Rod Embodiment With Cooper’s Wrist And The
`Combination of Prisco’s Cable Embodiment With Cooper’s
`Wrist Does Not Fall Within The Scope of Claim 24 .......................... 33
`
`VII. CONCLUSION .............................................................................................. 38
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`
`ii
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`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`In re Arkley,
`455 F.2d 586 (C.P.A. 1972) ................................................................................ 24
`Connell v. Sears, Roebuck & Co.,
`722 F.2d 1542 (Fed. Cir. 1983) .......................................................................... 23
`General Elec. Co. v. United Techs. Corp.,
`IPR2017-00428, Paper No. 38 (P.T.A.B. June 22, 2018) .............................. 3, 35
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) .......................................................................... 33
`Microsoft Corp. v. Biscotti, Inc.,
`878 F.3d 1052 (Fed. Cir. 2017) .................................................................... 23, 31
`Net MoneyIN, Inc. v. VeriSign, Inc.,
`545 F.3d 1359 (Fed. Cir. 2008) .......................................................................... 23
`Polaris Indus., Inc. v. Arctic Cat, Inc.,
`882 F.3d 1056 (Fed. Cir. 2018) ................................................................ 3, 35, 36
`Standard Oil Co. v. Am. Cyanamid Co.,
`774 F.2d 448 (Fed. Cir. 1985) ............................................................................ 36
`Other Authorities
`37 C.F.R. § 42.100(b) .............................................................................................. 11
`37 CFR § 42.23(b) ................................................................................................... 26
`77 Fed. Reg. 48,756, 48,766 (Aug. 14, 2012) ......................................................... 11
`
`
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`iii
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`Exhibit #
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`2001
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`2002
`2003
`2004
`2005
`2006
`2007
`2008
`2009
`2010
`2011
`2012
`2013
`2014
`2015
`2016
`2017
`2018
`2019
`2020
`2021
`2022
`
`EXHIBIT LIST
`
`
`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
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`[Reserved]
`Declaration of Shorya Awtar
`Deposition Transcript of Bryan Knodel, IPR2018-01248, April 4,
`2019
`
`
`
`iv
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`I.
`
`INTRODUCTION
`The challenged claims of U.S. Patent No. 8,479,969 (“the 969 Patent”) are
`
`directed to an articulating endocutter surgical tool that operatively couples to a robot
`
`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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`Petitioner’s grounds are based on U.S. Patent No. 8,545,515 (“Prisco”), which
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`discloses an endoscopic surgery instrument that extends through a rigid, curved
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`cannula. The instrument has an end effector comprised of two jaws that open and
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`close, and couples to a robotic system through a tool base that provides drive
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`mechanisms only for shaft rotation and gripping the jaws. Prisco discloses two
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`different mechanisms for grip: a cable “pull-pull” embodiment, and a drive rod
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`“push-pull” embodiment. In order to arrive at the more sophisticated instruments
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`claimed by the 969 Patent, Petitioner proposes to combine Prisco, either through
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`incorporation by reference or by an obviousness argument, with an articulating
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`multi-disk wrist mechanism disclosed in U.S. Patent Nos. 6,817,974 (“Cooper”).
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`Petitioner’s case hinges on a proposed combination of Prisco’s drive “push-pull”
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`embodiment with the articulating wrist of Cooper (because the combination of
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`1
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`
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`Prisco’s “pull-pull” embodiment with Cooper does not fall within the scope of the
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`challenged claims). As explained below, Petitioner has failed to demonstrate that
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`the challenged claims are anticipated or obvious.
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`First, Petitioner’s anticipation ground fails because Prisco does not disclose
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`all of the elements as arranged in the challenged claims of the 969 Patent.
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`Specifically, Prisco does not disclose a surgical instrument that includes an end
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`effector with a selectively movable component, a gear-driven portion in operable
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`communication with the selectively movable component, an articulation joint, and a
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`transmission assembly in meshing engagement with a gear-driven portion to apply
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`a control motion to the selectively movable component, as required by claim 24.
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`Petitioner’s contention that the incorporation by reference of Cooper results in an
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`anticipation is simply wrong. The portion of Prisco that references Cooper does so
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`for the purpose of explaining that an articulation wrist was omitted to simplify the
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`instrument. Furthermore, Prisco’s drive rod “push-pull” embodiment is not
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`compatible with Cooper’s wrist, and therefore, a POSITA would not have
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`understood Prisco to disclose combining Cooper’s articulating wrist into Prisco’s
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`drive rod embodiment.
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`Second, to the extent that Petitioner advances an alternative anticipation
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`theory based on Prisco’s cable “pull-pull” embodiment with Cooper’s articulating
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`wrist, this theory fails because the posited instrument does not disclose “at least one
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`2
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`
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`gear-driven portion that is in operable communication with at least one selectively
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`movable component of said surgical end effector” and a “transmission assembly...in
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`meshing engagement with...[the] gear-driven portion...to apply at least one control
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`motion to [the] selectively movable component” as required by claim 24. The only
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`gear-driven portion in this combination is a gear mechanism that operates the motion
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`of rolling the instrument shaft. As both parties’ experts agree, the gear mechanism
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`for rolling the shaft does not operate and apply a control motion to a selectively
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`movable component of the end effector.
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`Third, Petitioner’s obviousness grounds are not supported by a plausible
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`motivation to combine Prisco’s drive rod embodiment with Cooper’s multi-disk
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`wrist mechanism. The facts here demonstrate that Prisco was specifically aware of
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`the benefits and drawbacks of a wrist mechanism and chose to eliminate the wrist in
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`order to avoid complicating the instrument design. This is teaching away. Polaris
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`Indus., Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1069 (Fed. Cir. 2018) (“A reference
`
`may be said to teach away when a person of ordinary skill, upon reading the
`
`reference, would be discouraged from following the path set out in the reference, or
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`would be led in a direction divergent from the path that was taken by the applicant.”);
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`see also General Elec. Co. v. United Techs. Corp., IPR2017-00428, Paper No. 38 at
`
`p. 24 (P.T.A.B. June 22, 2018) (“[Prior Art A] expressly considered at least some of
`
`the one-stage versus two-stage tradeoffs and specifically chose the one-stage option.
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`3
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`
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`By expressly weighing the tradeoffs and choosing the one-stage option, [Prior Art
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`A] teaches away from modifying the Wendus ADP engine to include the two-stage
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`option.”). Moreover, as explained by Dr. Awtar, a POSITA would have recognized
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`that Cooper’s multi-disk wrist and Prisco’s drive rod embodiment are incompatible,
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`and therefore a POSITA would not have been motivated to pursue the combination.
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`Indeed, to the extent that a POSITA would have been motivated to combine Prisco
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`with Cooper, she would have chosen the conventional path of Prisco’s cable “pull-
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`pull” embodiment to combine with Cooper’s multi-disk wrist, because Cooper
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`expressly teaches that the multi-disk wrist works in conjunction with a cable grip
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`mechanism. But as already explained above, this latter combination does not render
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`claim 24 obvious because it lacks a gear drive that is in operable communication
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`with a selectively movable component of the end effector and a transmission
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`assembly in meshing engagement with the gear-driven portion to apply a control
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`motion to the selectively movable component.
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`For these reasons, explained in detail below, Patent Owner respectfully
`
`requests that the Board find that Petitioner has failed to demonstrate that challenged
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`claims 24-26 of the 969 Patent are unpatentable.
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`II. THE 969 PATENT
`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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`4
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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 movable component
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`of the end effector as well as an elongated shaft comprising proximal and distal spine
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`portions coupled at an articulation joint to facilitate articulation of the end effector.
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`Ex. 1001, claim 24. The claimed surgical tools each include “a tool mounting
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`portion operably coupled to” the instrument shaft that is “configured to operably
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`interface with the tool drive assembly” of the robotic system in order to apply control
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`motions to various components of the instrument, such as the cutting blade or the
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`selectively movable end effector. Id.; Ex. 2021, ¶ 21. An endocutter embodiment
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`of the 969 Patent is depicted in Figure 132:
`
`Ex. 1001, Fig. 132 (annotated)
`5
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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). Ex. 1001, 77:7-13. The endocutter end effector also includes a
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`cutting instrument that moves between first and second positions relative to the
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`lower jaw (6022). Id., 84:27-37. As shown in the figure below, the tool base
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`includes transmission assemblies (closure transmission 6512 and knife drive
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`transmission 6550) in meshing engagement with a gear-driven portion to provide the
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`control motions of both clamping (i.e., closing the selectively movable jaws of the
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`end effector) and firing. Id., 83:24-31, 84:38-48. In this way, the 969 Patent provides
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`a tool base that is driven by electric motors and is capable of generating sufficient
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`force to clamp and fire an endocutter. Ex. 2021, ¶ 21.
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`Ex. 1001, Fig. 136 (annotated)
`6
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`Claim 24 further requires 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. The end effector 6012 is located on one end of the elongated shaft (6008),
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`which has an articulation joint (6100). Ex. 1001, 76:62-67. The articulation joint
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`6100 allows the shaft to selectively articulate on two axes, one that is transverse to
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`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). As can be in seen in Figure 133, the articulation joint is controlled by two
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`pairs of articulation cables, designated 6144, 6146, 6150 and 6152. Ex. 2021, ¶¶ 22-
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`23:
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`Ex. 1001, Fig. 133
`7
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`The articulation joint is operably coupled to the tool mounting portion by the
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`articulation cables thereby allowing the joint to be operated by rotary motion
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`received from the robotic system.1 Ex. 2021, ¶¶ 23-24. As indicated by the red lines
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`below in Figure 136, the articulation cables 6144 and 6150 enter the tool mounting
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`portion through passages in the instrument shaft (the cables 6146 and 6152, which
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`run parallel to 6144 and 6150 are not visible in this perspective). Ex. 2021, ¶¶ 23-
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`24.
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`Ex. 1001, Fig. 136 (annotation in red)
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`
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`1 The endocutter embodiment in Figures 32-36 also includes an articulation joint
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`operably coupled to the tool mounting portion. Ex. 1001, 30:65-31:43. The
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`embodiment in Figures 32-36 can only articulate about one axis.
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`8
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`As shown in Figure 137 below, the articulation cables couple to an articulation
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`control arrangement 6160 of the tool mounting portion. Ex. 1001, 79:28-53. As
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`shown in detail in Figure 137, the articulation control arrangement is, through a
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`series of push cables and gears, coupled to the articulation drive gear 6322, which
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`receives rotary motion from the robotic system through a rotary element on the
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`adapter side of the tool mounting portion, thus allowing the robotic system to operate
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`the articulation joint. Id., 79:54-80:39; Ex. 2021, ¶ 24.
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`Ex. 1001, Fig. 137 (annotated)
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`9
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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., 85:17-32. As noted in the 969 Patent, “[t]he unique
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`and 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, which were “unable to generate the magnitude
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`of forces required to effectively cut and fasten tissue,” the gears of the 969 Patent’s
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`embodiments were further sized to generate the necessary force to close the anvil
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`and cut and staple tissue. Id., 23:6-29, 84:20-26, 85:4-10; Ex. 2021, ¶ 25.
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`III. LEVEL OF ORDINARY SKILL IN THE ART
`A person of ordinary skill in the art would have had the equivalent of a
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`Bachelor’s degree or higher in mechanical engineering, with at least 3 years working
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`experience in the design of comparable surgical devices. In addition, such a person
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`would have had an understanding as to how the design of an instrument can affect
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`the clinical outcomes associated with the use of that instrument (e.g., how effective
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`a particular instrument design is at forming staples). Ex. 2021, ¶¶ 5-6.
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`10
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`
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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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`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)2.
`
`V. THE PRIOR ART
`A.
`Prisco
`Prisco is directed to an endoscopic surgery instrument that extends through a
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`rigid, curved cannula. Ex. 1006, Abstract. Prisco discloses inserting flexible
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`instruments into the surgical site through rigid curved cannulas, thus allowing for
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`easier insertion and removal while maintaining effective triangulation and surgical
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`action at the surgical site. Id., 1:58-2:42; Ex. 2021, ¶ 32. Prisco also discloses a
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`robotic control system that uses kinematic data to allow more intuitive control of the
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`instruments. Ex. 1006, 2:51-60; Ex. 2021, ¶ 33. Examples of Prisco’s curved
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`cannula systems are shown in Figures 4C and 5. As shown in Figure 4C, curved
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`cannulas 416a and 416b allow instruments to be introduced into the surgical site. As
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`2 Because Petitioner filed its Petition on June 14, 2018, the broadest reasonable
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`interpretation standard should apply to this IPR pursuant to pre-October 11, 2018 37
`
`C.F.R. § 42.100(b).
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`11
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`
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`shown in Figure 5, each instrument has an end effector 504 and a passively flexible
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`shaft 506. Ex. 1006, 12:8-17. The shaft sections 506a-506c are sufficiently rigid to
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`transmit shaft roll motions. Id., 12:45-49; Ex. 2021, ¶ 34.
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`
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`Ex. 1006, Figs. 4C and 5
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`The requirement that an endoscopic instrument be capable of passing through
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`a rigid, curved cannula increases the complexity of the structures and components
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`that must be part of the instrument shaft. Ex. 2021, ¶ 35. As shown in Figures 8A
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`through 8D and the accompanying text, Prisco’s instrument includes, for example,
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`12
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`
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`support tubes 806a and 806b, which help prevent the tension elements from buckling
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`or kinking within the shaft. Ex. 1006, 17:5-8; Ex. 2021, ¶ 36. To reduce friction,
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`these support tubes also include a friction reducing sheath 808a or 808b. Ex. 1006,
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`17:12-16; Ex. 2021, ¶ 37. Additionally, an inner shaft tube 810 is provided to
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`enclose both support tubes 806a and b and to provide torsional stiffness during shaft
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`rotation. Ex. 1006, 17:16-20; Ex. 2021, ¶ 38. The outer shaft tube is further
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`surrounded by a skin 814 that facilitates the sliding of the shaft through a curved
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`cannula. Ex. 1006, 17:22-27; Ex. 2021, ¶ 39.
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`Ex. 1006, Fig. 8A
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`
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`As Dr. Awtar explains, the inclusion of these additional structures
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`significantly complicates the instrument shaft design and reduces the amount of
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`13
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`
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`space that is available for providing additional mechanisms, such as articulation, and
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`as a result, although Prisco mentions the possibility of an articulation joint, it
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`specifically discloses that omitting an articulation joint simplifies the instrument and
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`reduces instrument dimensions. Ex. 2021, ¶¶ 41-42; Ex. 1006, 10:43-55. Prisco
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`explains, for example, that many instrument implementations do not include a wrist,
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`and that omitting the wrist “simplifies the number of actuation force interfaces”
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`between the robotic surgery system and the instrument, and also “reduces the
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`number of force transmission elements (and hence, instrument complexity and
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`dimensions) that would be necessary” between the force transmission mechanism
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`and the portion of the instrument being actuated. Ex. 1006, 10:48-55; Ex. 2021, ¶
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`42. Consistent with this disclosure of omitting the wrist, Prisco does not disclose a
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`curved cannula instrument that includes an articulation joint and associated
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`mechanisms for driving articulation. Ex. 2021, ¶ 43. Instead, Prisco expressly
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`discloses that its instrument base is a modified da Vinci Surgical System base in
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`which the articulation mechanisms have been eliminated. Ex. 1006, 14:59-64 (“As
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`shown in FIG. 7A, the force transmission mechanism of a surgical instrument used
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`in a da Vinci® Surgical System has been modified to eliminate the mechanisms
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`used to control a wrist mechanism on the instrument”)3; Ex. 2021, ¶ 43.
`
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`3 All emphasis added unless otherwise noted.
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`14
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`1.
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`Prisco Discloses Two Distinct Grip Mechanisms: Cable
`“Pull-Pull” and Drive Rod “Push-Pull”
`For robotic surgery, the instruments couple to the robotic system through an
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`instrument base, which Prisco calls a “force transmission mechanism 502.” Figures
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`7B and 7D illustrate the two distinct embodiments of Prisco’s instrument base that
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`drive gripping of the end effector jaws (as well as rolling of the shaft). Ex. 2021, ¶
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`44.
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`Figure 7B’s instrument base is shown below along with the corresponding end
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`effector of Figure 9C that the instrument base controls. This embodiment discloses
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`a cable operated “pull-pull” design for grip. Ex. 2021, ¶ 45.
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`Ex. 1006, Figs. 7B and 9C (annotated)
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`
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`As indicated in red, capstan 736 is coupled to two tension elements (i.e., cables) 734.
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`Ex. 1006, 15:36-43. Rotating the capstan 736 pulls one of the two cables (depending
`15
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`
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`on direction of rotation), which in turn opens or closes the end effector jaws as shown
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`in Figure 9C. Id., 15:39-43, 19:23-27. Prisco discloses that the cable, for example,
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`may be “0.018-inch tungsten.” Id., 14:6-14; Ex. 2021, ¶ 46. This design does not
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`include a transmission assembly in meshing engagement with a gear-driven portion
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`to apply a control motion to a selectively movable component of the end effector.
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`Ex. 2021, ¶ 47.
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`Figures 7C/7D and 9E illustrate a different embodiment of Prisco’s
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`instrument. This embodiment discloses a drive rod “push-pull” design for grip. Ex.
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`2021, ¶ 48.
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`Ex. 1006, Figs. 7D and 9E (annotated)
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`
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`In this embodiment, two pinion drive gears 782 (shown in red) engage a rack gear
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`784, which is coupled to a “push/pull drive element rod” (i.e., drive rod). Ex. 1006,
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`16
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`
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`16:19-29. As shown in Figure 9E, pushing the drive rod causes the end effector jaws
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`to open, while pulling it back causes the jaws to close. Id., 19:42-47. Thus, the rod
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`must transmit force to the jaws when both pushed and pulled. Ex. 2021, ¶ 49. Prisco
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`discloses that the drive rod, for example, may be a “solid rod (e.g., 304V Stainless
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`Steel, 0.032-inch OD with PTFE spray coating.).” Ex. 1006, 14:41-45; Ex. 2021, ¶
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`49.
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`
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`2.
`Prisco’s Shaft Roll Mechanism
`As shown above in both the cable “pull-pull” embodiment and the drive rod
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`“push-pull” embodiment, the tool base includes a shaft roll gear and helical drive
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`gear, shown in green, to provide a shaft roll motion. This gear-drive mechanism
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`does not involve applying a motion to a selectively movable component of the end
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`effector. Ex. 2021, ¶¶ 50-51; Ex. 2022, 9:6-16; 10:5-17 (“Q. Okay. When the shaft
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`of these instruments is rolled, using that mesh arrangement we just talked about in
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`Figure 7B, C, and D, you would agree that those jaws do not move relative to one
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`another; right? A. I believe that to be true, yes.”).
`
`B. Cooper
`Cooper is an issued patent that discloses a surgical instrument with a “wrist
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`mechanism” that provides articulation in the form of “pitch and yaw rotation in such
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`a way that the tool has no singularity in roll, pitch, and yaw.” Ex. 1007, Abstract;
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`Fig. 36; Ex. 2021, ¶ 53. “Singularity,” according to Cooper, refers to a problem in
`
`17
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`prior art articulating instruments in which, at “about 90° pitch, the yaw and roll
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`rotational movements overlap, resulting in the loss of one degree of rotational
`
`movement.” Ex. 1007, 2:58-60; Ex. 2021, ¶ 54. Cooper discloses a “multi-disk”
`
`wrist mechanism comprised of “a plurality of disks or vertebrae stacked or coupled
`
`in series,” with each disk “configured to rotate in at least one degree of freedom or
`
`DOF (e.g., in pitch or in yaw) with respect to each neighboring disk or end member.”
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`Id., 2:63-3:9. “Actuation cables or tendon elements are used to manipulate and
`
`control movement of the disks, so as to effect movement of the wrist mechanism.”
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`Id., 3:21-23. Cooper’s wrist mechanism is depicted in Figures 39 and 40. Ex. 2021,
`
`¶¶ 55-56.
`
`
`Ex. 1007, Figs. 39 and 40
`
`
`
`18
`
`
`
`
`
`Cooper also discloses a cable pull-pull mechanism for end effector gripping
`
`that is compatible with the disclosed wrist mechanism. Ex. 1007, 13:50-52 (“The
`
`lumen formed by the annular disks can be used for isolation and for passing pull
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`cables for grip.”); see also 17:25-21:15 (section described “Grip Actuation
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`Mechanism”); Ex. 2021, ¶ 57. As shown in Figure 39, actuator cables 446 and 448
`
`run through the interior of the disks that make up the wrist mechanism. The opening
`
`and closing of the end effector jaws (not shown in these figures) is controlled by
`
`pulling on the opening actuator cable 446 and closing actuator cable 448,
`
`respectively. Ex. 1007, 17:65-18:33; Ex. 2021, ¶ 58. As shown in Figure 40, wrist
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`control cables 452 and 454 also run through the interior of the disks, and are used to
`
`manipulate the movement of the wrist joint. Ex. 1007, 18:42-51; Ex. 2021, ¶ 59.
`
`Cooper explicitly notes that “the grip mechanism needs to be able to bend
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`sharply.” Ex. 1007, 13:55-56; Ex. 2021, ¶ 60. Accordingly, as explained by Dr.
`
`Awtar, it is not surprising that Cooper discloses no embodiments and makes no
`
`mention whatsoever of combining the articulating wrist mechanism with a solid
`
`drive rod “push-pull” grip mechanism given the requirement for bending sharply.
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`Ex. 2021, ¶¶ 61-62. Indeed, Cooper’s disclosure of a grip mechanism compatible
`
`with the multi-disk wrist is solely directed to a “pull-pull” cable design. Ex. 1007,
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`13:50-61, 17:25-21:15; Ex. 2021, ¶ 61.
`
`19
`
`
`
`
`
`Cooper’s instrument couples to a robotic surgery system through an
`
`instrument base, which Cooper refers to as the “back end” 801 and which is depicted
`
`in Figures 64 and 65. Ex. 2021, ¶ 63. A close-up of the operative portions of the
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`back end 801 is further provided in Figure 67, which has been annotated below. Ex.
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`2021, ¶ 64.
`
`
`
`Ex. 1007, Fig. 67 (annotated)
`
`
`
`As shown in the figure above, the back end includes follower gear quadrants 814
`
`and 816, which drive actuator links 804 and 806 to produce pitch and yaw rotations.
`
`Ex. 1007, 24:8-21. The follower gear quadrants 814 and 816 are rotated by the first
`20
`
`
`
`
`
`and second drive gears 824 and 826, which receive rotary motion from the robotic
`
`system via drive spools 834 and 836. Id., 24:12-14; Ex. 2021, ¶ 65. The drive gears
`
`824 and 826 and drive spools 834 and 836 are annotated in blue, above. The grip
`
`actuation cables 446 and 448 that control the opening and closing of the end effector
`
`terminate at a pair of hub clamps 866 and 868, and are tensioned by applying torque
`
`(i.e., rotary motion from the robotic system) to the hub clamps. Id., 24:34-39. The
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`hub clamps 866 and 868 are indicated above in red. Ex. 2021, ¶ 66. Finally, a helical
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`drive gear 840 drives a follower gear 842 to provide shaft roll. Ex. 1007, 24:21-23.
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`The helical drive gear 840 and follower gear 842 are indicated above in green. Ex.
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`2021, ¶ 67. The above tool base in Cooper, like the cable “pull-pull” embodiment
`
`of Prisco, does not include a transmission assembly in meshing engagement with a
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`gear-driven portion to apply a control motion to a selectively movable component
`
`of the end effector. Ex. 2021, ¶ 68.
`
`C. Wallace
`Wallace is directed to providing a robotic surgical instrument that addresses
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`the “lack of dexterity” with existing endoscopic tools and “include[s] mechanisms
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`to provide three degrees of rotational movement of an end effector around three
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`perpendicular axes to mimic the natural action of surgeon’s wrist.” Ex. 1008, 2:39-
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`41, 2:60-65; Ex. 2021, ¶ 70. Wallace achieves this objective with a platform wrist
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`mechanism shown in Fig. 3. Ex. 2021, ¶¶ 71. Petitioner relies on Wallace solely
`
`21
`
`
`
`
`
`with respect to the limitations of dependent claims 25 and 26; Petitioner does not
`
`cite Wallace for any of the limitations of independent claim 24.
`
`D. Tierney
`Tierney is a patent directed to a robotic surgical system. Ex. 2021, ¶ 78. Prisco
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`purports to incorporate Tierney by reference, at least insofar as Tierney discloses a
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`data architecture for storing operational parameters in the memory of the robotic
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`system. Ex. 1006, 15:12-20; Ex. 2021, ¶ 79. Petitioner relies on Tierney solely for
`
`its disclosure of the robotic system; Petitioner does not cite Tierney for any specifics
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`of the surgical instrument that couples to the robotic system. Ex. 2021, ¶ 80.
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`VI. THE CHALLENGED CLAIMS ARE PATENTABLE
`The table below sets forth the Grounds and references relied upon:
`
`Ground Claims
`1
`24-26
`2
`24-26
`3
`24-26
`4
`25-26
`
`Argument
`Anticipated by Prisco
`Obvious over Prisco in view of Cooper
`Obvious over Prisco in View of Cooper and Tierney
`Obvious over Prisco in view of Cooper and Wallace, and
`if necessary, Tierney
`
`
`As set forth below, Prisco does not anticipate claims 24-26 because a POSITA
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`would not have understood Prisco to disclose, and would not have immediately
`
`envisaged, a surgical instrument with all of the elements recited in claim 24, arranged
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`as in the claim. Additionally, none of Petitioner’s obviousness combinations in
`
`Grounds 2-4 render claims 24-26 obvious, because a POSITA would not have been
`
`motivated to combine Prisco’s drive rod “push-pull” embodiment with Cooper’s
`22
`
`
`
`
`
`articulating wrist mechanism, and the combination of Prisco’s cable “pull-pull”
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`embodiment with Cooper’s articulating wrist mechanism does not fall within the
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`scope of claim 24. Ex. 2021, ¶¶ 82.
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`A. Ground 1: Prisco Does Not Disclose All Limitations Of Claim 24
`Arranged As In The Claim, And A POSITA Would Not Have At
`Once Envisaged Such An Arrangement
`Petitioner asserts in Ground 1 that Prisco anticipates claims 24-26.
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`Petitioner’s anticipation claim is defective because Prisco does not disclose all of the
`
`claim limitations of claim 24 as arranged in the claim and a POSITA reading Prisco’s
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`disclosure would not have at once envisaged an instrument having all of the claim
`
`elements arranged as in claim 24. Prisco therefore cannot anticipate any of claims
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`24-26. Ex. 2021, ¶ 85.
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`In order to anticipate the claimed invention, a prior art reference must
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`“disclose all elements of the claim within the four corners of the document,” and it
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`must “disclose those elements ‘arranged as in the claim.’” Net MoneyIN, Inc. v.
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`VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008) (quoting Connell v. Sears,
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`Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983)). While a publication does
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`not need to “expressly spell out” all limitations combined as in the claim,
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`“anticipation is not proven by multiple, distinct teachings that the artisan might
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`somehow combine to achieve the claimed limitation.” Microsoft Corp. v. Biscotti,
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`Inc., 878 F.3d 1052, 1069 (Fed. Cir. 2017) (internal quotations and citation omitted);
`
`23
`
`
`
`
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`see also In re Arkley, 455 F.2d 586, 587 (C.P.A. 1972) (“[T]he [prior art] reference
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`must clearly and unequivocally disclose the claimed [invention] or direct those
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`skilled in the art to the [invention] without any need for picking, choosing, and
`
`combining various disclosures not directly rel
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