UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`v.
`
`ETHICON LLC,
`Patent Owner
`
`IPR2018-01254
`U.S. Patent No. 8,479,969
`
`
`
`
`
`PATENT OWNER’S RESPONSE
`
`
`
`
`
`
`
`
`
`

`

`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`
`Page
`
`INTRODUCTION ....................................................................................... 1
`
`THE 969 PATENT ....................................................................................... 4
`
`III. CLAIM CONSTRUCTION ........................................................................ 10
`
`IV. THE PRIOR ART ....................................................................................... 11
`
`A. Giordano ........................................................................................... 11
`
`B.
`
`Shelton .............................................................................................. 13
`
`C. Wallace ............................................................................................. 15
`
`D.
`
`Tierney ............................................................................................. 16
`
`V.
`
`THE CHALLENGED CLAIMS ARE PATENTABLE .............................. 17
`
`A.
`
`Claim 24: Combining Shelton’s Endocutter With Giordano’s
`Articulation Mechanism Fails To Disclose Or Render Obvious
`Limitation 24.3 (“wherein said surgical tool further comprises:
`a tool mounting portion operably coupled to a distal end of said
`proximal spine portion, said tool mounting portion being
`configured to operably interface with the tool drive assembly
`when coupled thereto”) ..................................................................... 17
`
`B.
`
`Claims 11 and 24: A POSITA Would Not Have Been
`Motivated to Make Petitioner’s Alternative Combination of
`Shelton’s Stapler with Wallace’s Platform Wrist .............................. 21
`
`1.
`
`2.
`
`Combining Shelton’s Endocutter With Wallace’s Wrist
`Mechanism And Tool Drive Would Have Resulted In An
`Inoperable Device Because Shelton’s Firing Mechanism
`Is Incompatible With Wallace’s Wrist .................................... 23
`
`Combining Shelton’s Endocutter With Wallace’s Wrist
`Mechanism And Tool Drive Requires More Control
`Inputs Than Are Available in Wallace/Tierney ....................... 25
`
`i
`
`

`

`C.
`
`D.
`
`E.
`
`F.
`
`Claims 11 and 24: A POSITA Would Have Been Deterred
`From Making Any Of Petitioner’s Proposed Combinations .............. 27
`
`Claims 11 and 24: A POSITA Would Not Have Had A
`Reasonable Expectation of Success ................................................... 31
`
`1.
`
`2.
`
`3.
`
`Petitioner Fails To Show A Reasonable Expectation Of
`Success ................................................................................... 32
`
`A POSITA Would Have Recognized That Combining
`Giordano Or Shelton’s Handheld Endocutter With
`Wallace Or Tierney’s Tool Base Would Have Required
`A Significant Redesign to Provide Sufficient Forces for
`the Endocutter ......................................................................... 34
`
`Publications from Patent Owner and Petitioner Confirm
`that a POSITA Would Have Lacked a Reasonable
`Expectation Of Success ........................................................... 37
`
`Claims 1-10: A POSITA Would Have Been Deterred From
`Combining The References As Petitioner Proposes .......................... 41
`
`Claims 1-10: A POSITA Would Not Have Had A Reasonable
`Expectation Of Success In Combining The References As
`Petitioner Proposes ........................................................................... 41
`
`VI. CONCLUSION .......................................................................................... 42
`
`
`
`
`
`
`
`
`ii
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`

`

`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Apple Inc. v. Samsung Elecs. Co.,
`839 F.3d 1034 (Fed. Cir. 2016) (en banc) ........................................................ 27
`Belden Inc. v. Berk-Tek LLC,
`805 F.3d 1064 (Fed. Cir. 2015) ........................................................................ 22
`
`Compass Bank v. Intellectual Ventures II,
`IPR2014-00786, Paper 46 (P.T.A.B Sept. 23, 2015) ........................................ 33
`Corning Inc. v. DSM IP Assets,
`IPR2013-00050, Paper 77 (P.T.A.B. May 1, 2014) .......................................... 33
`Kinetic Concepts, Inc. v. Smith & Nephew, Inc.,
`688 F.3d 1342 (Fed. Cir. 2012) ........................................................................ 32
`Polaris Indus., Inc. v. Arctic Cat, Inc.,
`882 F.3d 1056 (Fed. Cir. 2018) ........................................................................ 27
`Other Authorities
`37 C.F.R. § 42.23(b) ............................................................................................. 19
`37 C.F.R. § 42.65(a) ............................................................................................. 33
`37 C.F.R. § 42.100(b) ........................................................................................... 10
`
`
`
`iii
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`

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`
`
`Exhibit #
`
`2001
`
`2002
`2003
`2004
`2005
`2006
`2007
`2008
`
`2009
`
`2010
`2011
`2012
`
`2013
`
`2014
`2015
`2016
`
`2017
`
`2018
`2019
`2020
`
`
`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)
`U.S. Patent No. 7,691,098
`U.S. Patent No. 7,524,320
`U.S. Patent No. 6,783,524
`Declaration of Dr. Shorya Awtar
`[Reserved]
`[Reserved]
`[Reserved]
`Mucksavage et al., Differences in Grip Forces Among Various
`Robotic Instruments and da Vinci Surgical Platforms, Journal Of
`Endourology, Vol. 25, No. 3 (March 2011)
`[Reserved]
`Deposition Transcript of Bryan Knodel, IPR2018-01254, April 4,
`2019
`U.S. Patent No. 8,640,788
`Order Invalidating the January 2018 Certificate of Correction
`Relating to U.S. Patent No. 8,479,969, Ethicon v. Intuitive Surgical,
`Inc., C.A. No. 17-871 (D. Del. Feb. 11, 2019)
`WIPO Publication No. 2015/153642 A1
`U.S. Patent No. 8,186,555
`U.S. Patent No. 5,307,976
`Hermann Mayer et al., Haptic Feedback in a Telepresence System
`for Endoscopic Heart Surgery, Presence, Vol. 16, No. 5, pp. 459-
`470 (October 2007).
`Allison M. Okamura, Haptic feedback in robot-assisted minimally
`invasive surgery, Current Opinion in Urology, 19:102-107 (2009).
`U.S. Patent Application Publication No. 2012/0209314
`[Reserved]
`
`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
`
`robotic surgical system. More specifically, the 969 Patent discloses an articulation
`
`joint and tool drive assembly that are designed to meet the demands of an
`
`endocutter coupled to a robotic system. The assembly disclosed in the 969 Patent
`
`improves upon prior robotic surgical tools, such as grasping jaws, scalpels and
`
`electrocautery probes, that were known to be “unable to generate the magnitude of
`
`forces required to effectively cut and fasten tissue” as is required of an endocutter.
`
`Ex. 1001, 23:6-29.
`
`Petitioner’s obviousness challenge is premised on the combination of U.S.
`
`Publication No. 2008/0167672 (“Giordano”) (Ex. 1014) and U.S. Patent No.
`
`6,978,921 (“Shelton”) (Ex. 1015), both of which disclose a handheld endocutter
`
`design, with U.S. Patent No. 6,699,235 (“Wallace”) (Ex. 1008), which discloses a
`
`two-axis wrist joint and corresponding tool base for non-endocutter robotic tools
`
`such as grasping jaws or forceps. As explained below, Intuitive has failed to
`
`demonstrate that the challenged claims are obvious.
`
`First,
`
`the proposed combination
`
`involving Giordano’s articulation
`
`mechanism fails to disclose the limitation in claim 24 requiring “a tool mounting
`
`portion operably coupled to a distal end of said proximal spine portion.” Petitioner
`
`1
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`

`

`
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`relies on a combination that includes Giordano’s articulation pivot 14 and
`
`articulation control 16. The proposed combination would not involve any operable
`
`coupling to the tool mounting portion disclosed in Wallace because Giordano’s
`
`articulation control is located on the elongate shaft. Indeed, the Petition and
`
`associated expert declaration from Dr. Knodel include no substantive explanation
`
`for why the proposed combination discloses an operable coupling between the
`
`distal end of the proximal spine portion and the tool mounting portion of Wallace.
`
`Second, Intuitive’s alternative combination of Shelton with Wallace’s wrist
`
`mechanism is entirely without merit as should be evident from the cursory
`
`treatment given to this alternate combination in the Petition. As explained by Dr.
`
`Shorya Awtar, a POSITA would not have made this proposed combination because
`
`Shelton’s firing bar is not designed to be twisted in multiple axes as would be
`
`required with Wallace’s wrist. Furthermore, the proposed combination requires
`
`closing, firing, two planes of articulation, and shaft roll, which amounts to more
`
`control inputs than are available in the Wallace/Tierney robotic system. A POSITA
`
`would not have pursued this combination because the Shelton reference
`
`specifically counsels against controlling closure and firing with a single input, and
`
`modification of the robotic system itself, such as by adding motor inputs, is not a
`
`viable design option for a POSITA to pursue.
`
`2
`
`

`

`
`
`Third, the Petition’s generic statements of desire to create a robotic
`
`endocutter fails to account for the reasons a POSITA would have been deterred
`
`from making the specific combination of the Giordano/Shelton handheld staplers
`
`with the Wallace/Tierney robotic system. As detailed in this submission, a
`
`POSITA would have been deterred from combining a handheld endocutter with a
`
`robotic system because the resulting device would lack the tactile feedback that
`
`surgeons deemed critical for operating an endocutter. In addition, a POSITA
`
`would have been deterred from combining Giordano’s articulation mechanism with
`
`Wallace because it would result in a device that has fewer degrees of movement
`
`and an articulation control located on the instrument shaft. Such a device is
`
`contrary to the intended purpose of Wallace, which is to provide more degrees of
`
`movement and remote operation of an instrument.
`
`Finally, a POSITA would not have had a reasonable expectation of success
`
`combining a handheld endocutter with the robotic tool bases disclosed in Wallace
`
`and Tierney. The difference between the non-endocutter tools and associated drive
`
`systems
`
`in Wallace and Tierney and
`
`the handheld endocutter
`
`tools
`
`in
`
`Giordano/Shelton is significant. The former involve a low torque, high speed
`
`motor to drive end effector controls requiring forces on the order of 10 pounds or
`
`less. The latter involve a high torque, low speed hand trigger to drive end effector
`
`controls requiring forces on the order of 70 to 120 pounds. Indeed, Intuitive’s
`
`3
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`

`

`
`
`expert admitted at his deposition that the tool base in Wallace is not designed to
`
`drive an endocutter. Ex. 2011 at 24:20-23.
`
` Moreover, Intuitive’s own
`
`contemporary patent filings confirm that existing robotic tools, such as those in
`
`Wallace and Tierney, could not generate sufficient clamping force. Ex. 2005 at
`
`¶¶93-101. Thus, Intuitive’s position in U.S. Patent No. 8,640,788 that there was a
`
`“need for surgical end effectors with high actuation force, for example, clamping
`
`force” (Ex. 2012 at 2:35-39) directly contradicts the conclusory assertion in this
`
`IPR that combining a handheld endocutter with a robotic system “would be merely
`
`the application of a known technique (use of a surgical stapler end effector) to a
`
`known system (a surgical robot) ready for improvement to yield predictable
`
`results.”
`
`For these reasons, and the additional reasons explained in detail below,
`
`Patent Owner respectfully requests that the Board find all challenged claims
`
`patentable over the asserted grounds of invalidity.
`
`II. THE 969 PATENT
`The challenged claims of
`
`the 969 Patent are directed
`
`to novel
`
`implementations of a “surgical tool for use with a robotic system.” The surgical
`
`tool of independent claim 24 includes, inter alia, a transmission assembly in
`
`meshing engagement with a gear-driven portion to apply control motions to a
`
`selectively moveable component of the end effector as well as an elongated shaft
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`4
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`
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`comprising proximal and distal spine portions coupled at an articulation joint to
`
`facilitate articulation of the end effector. Ex. 1001, claim 24. The claimed surgical
`
`tools each include “a tool mounting portion operably coupled to” the instrument
`
`shaft that is “configured to operably interface with the tool drive assembly” of the
`
`robotic system in order to apply control motions to various components of the
`
`instrument, such as the cutting blade or the selectively movable end effector. Id.;
`
`Ex. 2005, ¶ 20. An endocutter embodiment of the 969 Patent is depicted in Figure
`
`132:
`
`
`
`
`
`Ex. 1001, Fig. 132 (annotated)
`
`The instrument includes an endocutter end effector (6012) that has a
`
`movable upper jaw/anvil (6024) that moves between first and second positions
`
`relative to the lower jaw (6022). Ex. 1001, 77:7-13. The endocutter end effector
`
`5
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`

`

`
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`also includes a cutting instrument that moves between first and second positions
`
`relative to the lower jaw (6022). Ex. 1001, 84:27-37. As shown in the figure
`
`below, the tool base includes transmission assemblies (closure transmission 6512
`
`and knife drive transmission 6550) in meshing engagement with a gear-driven
`
`portion to provide the control motions of both clamping and firing. Ex. 1001,
`
`83:24-31, 84:38-48. In this way, the 969 Patent provides a tool base that is driven
`
`by electric motors and is capable of generating sufficient force to clamp and fire an
`
`endocutter. Ex. 2005, ¶ 20.
`
`Ex. 1001, Fig. 136 (annotated)
`
`
`
`6
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`

`

`
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`Claim 24 further requires an elongated shaft comprising proximal and
`
`distal spine portions coupled at an articulation joint to facilitate articulation of
`
`the end effector, and further that the tool mounting portion is operably coupled to
`
`the distal end of the proximal spine portion. The end effector 6012 is located on
`
`one end of the elongated shaft (6008), which has an articulation joint (6100). Ex.
`
`1001, 76:62-67. The articulation joint (6100), shown in Fig. 132, allows the
`
`shaft to selectively articulate on two axes, one that is transverse to the
`
`longitudinal tool axis (designated “LT”), and one that is transverse to both the
`
`first articulation axis and LT. Id., 77:38-46. These axes are designated “TA1”
`
`and “TA2” in Figure 133, which provides a more detailed view of the
`
`articulation joint (6100). As can be in seen in Figure 133, the articulation joint is
`
`controlled by two pairs of articulation cables, designated 6144, 6146, 6150 and
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`6152. Ex. 2005, ¶¶ 21-22.
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`7
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`
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`The articulation joint is operably coupled to the tool mounting portion by the
`
`Ex. 1001, Fig. 133
`
`articulation cables thereby allowing the joint to be operated by rotary motion
`
`received from the robotic system.1 Ex. 2005, ¶ 22. As indicated by the red lines
`
`below in Figure 136, the articulation cables 6144 and 6150 enter the tool mounting
`
`portion through passages in the instrument shaft (the cables 6146 and 6152, which
`
`run parallel to 6144 and 6150 are not visible in this perspective). Id.
`
`
`
`Ex. 1001, Fig. 136 (annotated)
`
`1 The endocutter embodiment in Figures 32-36 also includes an articulation joint
`
`operably coupled to the tool mounting portion. Ex. 1001, 30:65-31:43. The
`
`embodiment in Figures 32-36 can only articulate about one axis.
`
`8
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`

`
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`As shown in Figure 137 below, the articulation cables couple to an
`
`articulation control arrangement 6160 of the tool mounting portion. Id., 79:28-53.
`
`As shown in great detail in Figure 137, the articulation control arrangement is,
`
`through a series of push cables and gears, coupled to the articulation drive gear
`
`6322, which receives rotary motion from the robotic system through a rotary
`
`element on the adapter side of the tool mounting portion, thus allowing the robotic
`
`system to operate the articulation joint. Id. 79:54-80:39; Ex. 2005, ¶ 23.
`
`Ex. 1001, Fig. 137 (annotated)
`
`
`
`9
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`

`

`
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`Thus, as discussed above and described in detail by the 969 Patent, the
`
`“unique and novel transmission arrangement” of the 969 Patent allows a robotic
`
`system with four output motions to control (i) articulation about two different
`
`articulation axes that are substantially transverse to each other and the longitudinal
`
`tool axis; (ii) end effector rotation about the longitudinal tool axis; (iii)
`
`opening/closing of the end effector anvil to clamp tissue; and (iv) firing the cutting
`
`instrument to cut tissue. Id., 85:17-32. Furthermore, unlike prior art robotic tool
`
`drive systems, which were “unable to generate the magnitude of forces required to
`
`effectively cut and fasten tissue,” the closure drive and firing transmissions in the
`
`969 Patent are designed to generate the necessary force to close the anvil and cut
`
`and staple tissue. Id., 23:6-29, 84:20-26, 85:4-10; Ex. 2005, ¶ 24.
`
`III. CLAIM CONSTRUCTION
`For purposes of IPR only, the claims of the 969 Patent should be construed
`
`using the broadest reasonable construction in light of the specification of the
`
`patent.2
`
`
`2 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).
`
`10
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`

`
`
`IV. THE PRIOR ART
`A. Giordano
`Giordano is directed to a powered, handheld endocutter that includes a
`
`sensor in the end effector and a control unit in the handle. Ex. 1014, Abstract.
`
`Giordano describes that prior art “power-assist” endocutters had been developed to
`
`reduce the firing force required from the surgeon. Id. at [0013]. A challenge
`
`associated with these prior art power-assist devices was the need to deliver power
`
`or data signals to and from sensors and control systems in the instrument,
`
`particularly in instruments that had a “free rotating joint” (i.e., an articulation
`
`joint). Id. at [0014]; Ex. 2005, ¶ 31. To address these needs, Giordano discloses a
`
`handheld instrument with a passively powered sensor in the end effector. Ex. 1014
`
`at [0015]. The instrument handle includes a microcontroller that communicates
`
`with the sensor. Id. The instrument shaft, which includes a rotational joint, may
`
`act as an antenna to relay signals between the control unit and the sensor, thus
`
`overcoming the difficulties of providing a wired connection through the
`
`articulation joint. Id. at [0015]-[0017]; Ex. 2005, ¶ 32.
`
`An embodiment of Giordano’s device is shown in Figure 2 (illustrating the
`
`surgical instrument) and Figure 7 (exploded view of the handle system).
`
`11
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`

`
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`
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`FIG. 2
`
`Ex. 1014, Fig. 2
`
`12
`
`
`
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`Ex. 1014, Fig. 7
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`
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`
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`As shown in Figure 2, the instrument includes an end effector 12 with a
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`staple channel 22 and an anvil 24. Ex. 1014 at [0036]. The end effector is
`
`attached to a shaft 8, which has an articulation pivot 14. Id. at [0034]; Ex. 2005, ¶
`
`34. The surgeon controls rotational articulation about the pivot 14 using the
`
`articulation control 16. Id. Additionally, a rotation knob (not labeled in the figure)
`
`is used to rotate the shaft. Id. The device handle 6 includes a closure trigger 18
`
`and a firing trigger 20, shown in both Figures 2 and 7, to control closure and firing
`
`of the end effector, respectively. Id. at [0035]. Thus, Giordano’s instrument
`
`utilizes four separate input motions to control four different functions: (1)
`
`squeezing the closure trigger 18 to close the end effector, (2) squeezing the firing
`
`trigger 20 to control firing of the staples, (3) actuation of articulation control 16 to
`
`control articulation around the pivot 14, and (4) movement of the rotation knob to
`
`rotate the instrument shaft. Ex. 2005, ¶¶ 35-37.
`
`Shelton
`B.
`Shelton also discloses a handheld endocutter. Unlike Giordano’s endocutter,
`
`however, Shelton’s instrument does not include any power-assist functionality for
`
`firing and does not include an articulation joint. Ex. 2005, ¶ 41. Shelton’s
`
`instrument has a closure sleeve 32 that opens and closes the end effector under the
`
`control of a gear-driven closure trigger 26. Ex. 1015, Fig. 7; 5:63-6:3, 7:39-50; Ex.
`
`2005, ¶ 43.
`
`13
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`

`
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`Ex. 1015, Fig. 7
`
`
`
`Additionally, Shelton’s instrument provides shaft rotation through a rotation
`
`knob 60, and provides separate control of staple firing through a firing trigger 28.
`
`Id., 5:58-62, 7:16-27. Thus, Shelton’s instrument requires three control motions to
`
`perform three instrument operations: (1) pulling the closure trigger 26 to close the
`
`end effector, (2) pulling the firing trigger 28 to fire the stapler, and (3) turning the
`
`rotation knob to rotate the shaft. Ex. 2005, ¶¶ 44-45.
`
`14
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`

`
`
`C. Wallace
`Wallace is directed to providing a robotic surgical instrument that addresses
`
`the “lack of dexterity” with existing endoscopic tools and “include[s] mechanisms
`
`to provide three degrees of rotational movement of an end effector around three
`
`perpendicular axes to mimic the natural action of surgeon’s wrist.” Ex. 1008,
`
`2:39-41, 2:60-65. Wallace achieves this objective with a platform wrist
`
`mechanism shown in Fig. 3 (as well as in Fig. 2A with grasping jaws attached to
`
`the wrist mechanism). Ex. 2005, ¶¶ 48-49.
`
`
`
`
`
`Ex. 1008, Fig. 2A and Fig. 3
`
`Wallace’s instrument couples to a robotic system through a tool base 62,
`
`which is illustrated in Figures 26-30. Id., 7:37-40. It is undisputed that the tool
`
`base disclosed in Wallace is not designed to drive an endocutter and Wallace also
`15
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`

`

`
`
`does not disclose any mechanism for opening and closing the jaws of an end
`
`effector attached to the wrist mechanism. Ex. 2005, ¶ 54; Ex. 2011 at 24:20-23,
`
`28:23-29:10, 37:25-38:11. Wallace’s tool base utilizes three rotary drive motions
`
`(those of the two gears 400 and the one gear 420) to control two instrument
`
`motions (wrist articulation and shaft rotation). Ex. 2005, ¶¶ 51-53.
`
`Ex. 1008, Fig. 30
`
`
`
`D. Tierney
`Tierney is a patent directed to a robotic surgical system. Petitioner relies
`
`solely on Tierney solely for its disclosure of a robotic system. Petitioner does not
`
`cite Tierney for any specifics of a surgical instrument that couples to the robotic
`
`system. Ex. 2005, ¶ 60. As explained by Dr. Shorya Awtar, the robotic tools
`
`16
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`

`

`
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`discussed in Tierney fall into the category of tools that were unable to generate the
`
`forces needed to clamp and cut tissue required of an endocutter. Ex. 2005, ¶ 94.
`
`V. THE CHALLENGED CLAIMS ARE PATENTABLE
`As set forth in detail below, Petitioner’s proposed grounds do not invalidate
`
`claim 24 of the 969 Patent because none of the proposed combinations result in a
`
`device that includes a “tool mounting portion operably coupled to a proximal end
`
`of said proximal spine portion.” Additionally, all of Petitioner’s proposed
`
`combinations fail, with respect to each of the challenged claims, because a
`
`POSITA would have been deterred from making the proposed combinations, and
`
`because a POSITA would not have had a reasonable expectation of success in
`
`combining the references as proposed by Petitioner.
`
`A. Claim 24: Combining Shelton’s Endocutter With Giordano’s
`Articulation Mechanism Fails To Disclose Or Render Obvious
`Limitation 24.3 (“wherein said surgical tool further comprises: a
`tool mounting portion operably coupled to a distal end of said
`proximal spine portion, said tool mounting portion being
`configured to operably interface with the tool drive assembly
`when coupled thereto”)
`The Certificate of Correction submitted to replace “distal end of said
`
`proximal spine portion” in claim limitation 24.3 with “proximal end of said
`
`proximal spine portion” was invalidated by the United States District Court for the
`
`District of Delaware on February 11, 2019. Ex. 2013. Thus, claim 24 of the 969
`
`Patent requires a surgical tool that comprises “a tool mounting portion operably
`
`17
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`
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`coupled to a distal end of said proximal spine portion….” Petitioner’s only
`
`discussion of this requirement in the Petition is a single conclusory sentence
`
`contending that in the proposed grounds, “Wallace’s tool mounting portion would
`
`be operably coupled via the elongated shaft assembly to the distal end of proximate
`
`spine tube 46.” Petition at 90. The Petition cites ¶ 130 of Dr. Knodel’s
`
`declaration, which simply refers back to Dr. Knodel’s opinion for claim limitation
`
`1.4, which does not contain a corresponding requirement that the tool mounting
`
`portion be operably coupled to the distal end of a proximal spine portion. The
`
`previous paragraph in Dr. Knodel’s declaration, ¶ 129, does relate to the claim
`
`limitation at issue but simply recites the same conclusory sentence from the
`
`Petition without any explanation or analysis. Thus, as an initial matter, Petitioner
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`has failed to meet its burden of providing evidence to demonstrate that this
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`limitation is met in its proposed combinations. Moreover, Petitioner’s conclusory
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`assertion is incorrect because even assuming a POSITA would be motivated to do
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`so, the proposed combination of Shelton’s stapler with Giordano’s articulation
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`mechanism and Wallace’s tool base would not result in a tool mounting portion
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`operably coupled to the distal end of proximate spine tube 46.
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`In Ground 1, with respect to claim 24, Petitioner’s proposes combining
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`Shelton’s endocutter with Wallace’s tool mounting portion and Giordano’s
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`articulation joint 14 and articulation control 16. Petition at 85 (“a POSITA would
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`have understood that the Shelton stapler adapted for use with Giordano’s
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`articulation mechanism (see Ground 1, claim [11])”), 86-87 (repeated assertions
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`that the combination is “the Shelton stapler with Giordano’s articulation
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`mechanism”), 81 (defining “Giordano’s articulation mechanism” as including “an
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`articulation control 16 and an articulation pivot 14”).3 In this combination,
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`Petitioner specifically relies on Giordano’s proximate spine tube 46 as providing
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`the recited “proximal spine portion.” Petition at 87-88; Ex. 2005, ¶¶ 71-72. As
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`shown in Giordano’s Figure 5, however, the only operable feature located at the
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`distal end of the proximate spine tube 46 is the articulation assembly comprised of
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`bevel gears 52a-c. Ex. 1014, Fig. 5, [0041]; Ex. 2005 , ¶ 72. Giordano’s device
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`articulates this mechanism using articulation control 16, which is situated on the
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`3 During his deposition, Petitioner’s expert Dr. Knodel proposed, for the first time,
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`that a POSITA would have combined Shelton’s endocutter with Wallace’s tool
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`mounting portion and Giordano’s articulation joint, but without using Giordano’s
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`articulation control 16. Ex. 2011 at 15:1-17:8. This new theory is completely
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`absent from the Petition or Dr. Knodel’s declaration. See Petition at 81-84, 87-88;
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`Ex. 1005, ¶¶ 117-121, 127. Petitioner is precluded from presenting a new theory
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`of invalidity in its reply brief. 37 C.F.R. § 42.23(b); August 2018 Trial Practice
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`Guide Update at 14.
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`device shaft, away from the device handle (which, in Petitioner’s combination, is
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`replaced with Wallace’s tool mounting portion). Ex. 1014, Figs. 1-2, [0034]; Ex.
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`2005, ¶¶ 73-74. Thus, while the elongated shaft may operably couple articulation
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`control 16 to the articulation joint 14 found at the distal end of the proximate spine
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`tube 46, it does not operably couple the device handle to the articulation joint,
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`because the device handle plays no role in operating the articulation joint. As
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`explained by Dr. Awtar, when the Giordano/Shelton device handle is replaced with
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`Wallace’s tool mounting portion, there is no operable coupling between the tool
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`mounting portion and the proximate spine tube because a POSITA would
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`understand that Giordano’s articulation mechanism is designed to be operated by
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`the articulation control found on the shaft. Ex. 2005, ¶¶ 73-74.
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`In Ground 2, Petitioner’s proposed combination for claim 24 is identical to
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`that of Ground 1. The only difference is that Ground 2 treats Tierney as not being
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`properly incorporated by reference into Wallace. Petition at 90-91. Thus,
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`Petitioner’s argument against claim 24 for Ground 2 fails for the same reasons as
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`discussed above.
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`In Ground 4, Petitioner’s proposed combination for claim 24 is also identical
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`to that of Ground 1, with the only difference being that Ground 2 treats Tierney as
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`not being properly incorporated by reference into Wallace and Shelton as not being
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`properly incorporated by reference into Giordano. Petition at 92. Thus,
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`Petitioner’s argument against claim 24 for Ground 4 fails for the same reasons.
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`Petitioner does not address claim 24 as part of Grounds 3 or 5, and therefore
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`those grounds provide no basis to find that this claim limitation would have been
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`obvious.
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`B. Claims 11 and 24: A POSITA Would Not Have Been Motivated to
`Make Petitioner’s Alternative Combination of Shelton’s Stapler
`with Wallace’s Platform Wrist
`The Petition briefly identifies an alternative combination consisting of the
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`Shelton end effector with Wallace’s platform wrist mechanism and tool mounting
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`portion. Petition at 85, 88; see also Ex. 1005 at ¶¶ 121, 127. This alternative
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`combination is devoid of substance. Indeed, Dr. Knodel admitted at his deposition
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`that he was merely opining about what a POSITA could do, not what a POSITA
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`would have done:
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`Q: Is it your position that somebody would -- a person of ordinary
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`skill in the art would use the platform wrist mechanism in Wallace
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`with the Shelton stapler?
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`A: I didn’t really -- I didn’t consider the question from that
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`perspective. It wasn’t a question of would. It was a question of
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`could.
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`Ex. 2011 at 18:5-11. The Federal Circuit, however, has made clear that the
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`relevant inquiry is not merely whether a POSITA could have made the proposed
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`combination, but instead whether they would have been motivated to do so.
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`Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1073 (Fed. Cir. 2015)
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`(“[O]bviousness concerns whether a skilled artisan not only could have made but
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`would have been motivated to make the combinations or modifications of prior art
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`to arrive at the claimed invention.”) (emphasis in original). Furthermore, there is a
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`complete absence of explanation in the Petition for why the combination using
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`Wallace’s platform wrist includes “a proximal spine portion pivotally coupled to a
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`distal spine portion at an articulation joint.” Indeed, the analysis in the Petition for
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`why this limitation is disclosed is based on Fig. 5 of Giordano.4 See Petition at 87-
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`88.
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`Even assuming the proposed combination would in fact disclose a proximal
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`spine portion pivotally coupled to a distal spine portion at an articulation, a
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`POSITA would not have been motivated to combine Wallace’s wrist mechanism
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`4 Dr. Knodel also acknowledged at his deposition that he failed to provide any
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`explanation for why the combination using Wallace’s platform wrist includes a
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`proximal spine portion pivotally coupled to a distal spine portion at an articulation
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`joint. Ex. 2011 at 19:21-20:9.
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`with Shelton’s stapler with a reasonable expectation of success. As explained by
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`Dr. Awtar, a POSITA would have been deterred from the combination because (1)
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`Shelton’s firing mechanism is incompatible with Wallace’s wrist mechanism and
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`(2) Wallace’s robotic tools lack sufficient rotary inputs to control the necessary
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`motions of an articulating endocutter.
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`1.
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`Combining Shelton’s Endocutter With Wallace’s Wrist
`Mechanism And Tool Drive Would Have Resulted In An
`Inoperable Device Because Shelton’s Firing Mechanism Is
`Incompatible With Wallace’s Wrist
`In Shelton’s endocutter, the firing mechanism is driven by a firing bar 14
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`that is coupled to a firing connector 238, metal drive rod 140, and a firing drive
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`member 38, as shown in yellow in the following figure that Petitioner