`
`
`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 ETHICON LLC’S SUR-REPLY
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`I.
`
`II.
`
`TABLE OF CONTENTS
`
`INTRODUCTION .......................................................................................... 1
`
`PETITIONER’S PRIMARY COMBINATION DOES NOT
`DISCLOSE LIMITATION 24.3 ...................................................................... 3
`
`A.
`
`The Certificate Of Correction Is Invalid And Does Not Apply In
`This Proceeding ..................................................................................... 3
`
`1.
`
`2.
`
`Collateral Estoppel Bars Application of the Certificate ............. 4
`
`Judicial Estoppel Bars Application Of The Certificate .............. 5
`
`B.
`
`Petitioner’s Primary Combination Does Not Disclose Limitation
`24.3 As Originally Issued ...................................................................... 7
`
`III. A POSITA WOULD NOT HAVE BEEN MOTIVATED TO MAKE
`PETITIONER’S ALTERNATIVE COMBINATION .................................. 13
`
`IV. THE LOSS OF TACTILE FEEDBACK WOULD HAVE DETERRED
`A POSITA FROM ATTEMPTING EITHER THE PRIMARY
`COMBINATION OR THE ALTERNATIVE COMBINATION ................. 14
`
`V.
`
`TO DEMONSTRATE A
`FAILED
`PETITIONER HAS
`REASONABLE EXPECTATION OF SUCCESS ........................................ 20
`
`A.
`
`B.
`
`C.
`
`Petitioner’s Arguments Regarding the Capabilities of Tierney’s
`Robot Does not Demonstrate a Reasonable Expectation of
`Success ................................................................................................ 20
`
`Expert Testimony Concerning Gears Does Not Demonstrate a
`Reasonable Expectation of Success .................................................... 21
`
`Petitioner Fails To Rebut Evidence From Its Own Patent
`Applications ......................................................................................... 22
`
`VI. CONCLUSION .............................................................................................. 24
`
`
`
`
`i
`
`
`
`
`
`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Adidas AG v. Nike, Inc.,
`IPR2016-00922, 2019 WL 764425 (P.T.A.B. Feb. 19, 2019) ........................... 18
`Fisher & Paykel Healthcare Ltd. v. ResMed Pty Ltd.,
`IPR2017-00059, 2018 WL 1193320 (P.T.A.B. Mar. 7, 2018) ........................... 18
`New Hampshire v. Maine,
`532 U.S. 742 (2001) .............................................................................................. 6
`Plas-Pak Indus., Inc. v. Sulzer Mixpac AG,
`600 F. App’x 755 (Fed. Cir. 2015) ..................................................................... 18
`Polaris Inc. v. Arctic Cat, Inc.,
`882 F.3d 1056 (Fed. Cir. 2018) .......................................................................... 20
`Trustees in Bankr. Of N. Am. Rubber Thread Co. v. U.S.,
`593 F.3d 1346 (Fed. Cir. 2010) ............................................................................ 6
`Worlds Inc. v. Bungie, Inc.,
`903 F.3d 1237 (Fed. Cir. 2018) ............................................................................ 4
`Other Authorities
`37 C.F.R. § 42.23 ............................................................................................... 12, 14
`37 CFR § 42.6(a)(2)(ii) ............................................................................................ 25
`37 CFR § 42.6(a)(2)(iii) ........................................................................................... 25
`37 CFR § 42.8 .......................................................................................................... 25
`37 CFR § 42.24(a)(1)(i) ........................................................................................... 25
`
`ii
`
`
`
`EXHIBIT LIST
`
`2001
`
`
`
`Excerpts of a technology tutorial filed in Ethicon v. Intuitive
`Surgical, C .A. No. 1-17:cv-871 (LPS) (CJB) (D. Del. June 28,
`201 8)
`
`2002
`
`US. Patent No. 7,691,098
`
`2003
`
`US. Patent No. 7,524,320
`
`2004
`
`US. Patent No. 6,783,524
`
`
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
`
`2011
`
`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,
`20 l 9
`
`2012
`
`US. Patent No. 8,640,788
`
`2013
`
`
`
`Order Invalidating the January 2018 Certificate of Correction
`Relating to US. Patent No. 8,479,969, Ethicon v. Intuitive Surgical,
`Inc., CA. No. 17-871 (D. Del. Feb. 11, 2019)
`
`2014
`
`VVIPO Publication No. 2015/153642 A1
`
`2015
`
`US. Patent No. 8,186,555
`
`2016
`
`US. Patent No. 5,307,976
`
`2017
`
`2018
`
`
`
`
`
`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).
`
`ii1
`
`
`
`Exhibit #
`
`Description
`
`2023
`
`Defendants’ Opening Claim Construction Brief, Ethicon LLC et a].
`v. Intuitive Smgical Inc., et al., C .A. 17—871, D.I. 116 (D. Del. June
`
`28, 2018)
`
`
`2024
`
`2025
`
`Defendants’ Responsive Claim Construction Brief, Ethicon LLC et
`a]. v. Intuitive Smgical Inc., et 0]., C .A. 17-871, D1. 127 (D. Del.
`Aug. 1, 2018)
`
`Deposition of Dr. Bryan Knodel in IPR2018—01247 and IPR2018—
`01254 (August 12, 2019)
`
`2026—
`
`2027
`
`Notice of Waiver of Appeal Regarding the Court’s Order
`Invalidating the January 2018 Certificate of Correction Relating to
`US. Patent No. 8,479,969, C.A. 17-871, D1. 311 (D. Del.)
`
`iV
`
`
`
`
`
`I.
`
`INTRODUCTION
`Petitioner’s reply arguments fail to remedy the deficiencies in the Petition.
`
`For the reasons set forth in Patent Owner’s Response and this Sur-Reply, Patent
`
`Owner respectfully submits that Petitioner has failed to demonstrate that claims 1-
`
`11 and 24 of the ’969 Patent are obvious.
`
`First, Petitioner’s “primary combination” of Shelton’s stapler with Giordano’s
`
`articulation mechanism fails to disclose limitation 24.3 (“a tool mounting portion
`
`operably coupled to a distal end of said proximal spine portion”). Petitioner
`
`erroneously urges the Board to apply the Certificate of Correction in these
`
`proceedings, but the Certificate has been invalidated by the District of Delaware at
`
`Petitioner’s urging, and Ethicon has waived its right to appeal that decision.
`
`Accordingly, both issue preclusion and judicial estoppel bar Petitioner from
`
`changing its position on the applicability of the Certificate. Furthermore,
`
`Petitioner’s new arguments in Reply that the primary combination discloses
`
`limitation 24.3 as uncorrected are contradicted by Petitioner’s own characterization
`
`of the primary combination in the Petition and its expert declaration.
`
`Second, Petitioner’s “alternative combination” of Shelton’s stapler with
`
`Wallace’s articulation mechanism is unsupported by any motivation to combine. In
`
`an attempt to avoid Ethicon’s uncontested evidence that the Shelton firing
`
`mechanism is incompatible with the multi-axis wrist of Wallace, Petitioner argues
`
`1
`
`
`
`
`
`on Reply that a POSITA would have combined Shelton with Wallace’s articulation
`
`mechanism using only a single axis of articulation. The only motivation that
`
`Petitioner offered for the alternative combination, however, was the benefit of
`
`multiple axes of articulation. Thus, Petitioner’s newly raised reply combination with
`
`only one articulation axis is directly contrary to the only motivation that was set forth
`
`in the Petition for the proposed “alternative combination.”
`
`Third, Petitioner has failed to rebut Patent Owner’s argument that the loss of
`
`tactile feedback would have deterred one from combining Shelton’s handheld
`
`endocutter with Wallace’s robot. Petitioner’s expert, Dr. Knodel, asserts that tactile
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`feedback was available in Wallace’s robotic system, but ignores that Petitioner’s
`
`proposed combinations lack the sensors that Wallace explains are necessary to
`
`provide such feedback. In any event, Petitioner’s exhibits and cross-examination
`
`testimony of Dr. Knodel confirm Patent Owner’s arguments that tactile feedback
`
`was not available for robotic systems and was critical to the use of endocutters.
`
`Fourth, Petitioner has not demonstrated that a POSITA would have had a
`
`reasonable expectation of success combining Shelton and Wallace. Petitioner has
`
`assumed that a POSITA would have been able to design a new instrument drive
`
`system to provide power from Wallace’s robot to Shelton’s end effector, without any
`
`evidence or explanation. In contrast, Patent Owner’s expert, Dr. Awtar, provided a
`
`detailed analysis regarding the challenges a POSITA would have faced, and why one
`
`2
`
`
`
`
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`would have lacked a reasonable expectation of success. Dr. Awtar’s testimony is
`
`confirmed by Petitioner’s own contemporaneous patent applications, which describe
`
`that adapting a handheld endocutter for use with a robotic system was extremely
`
`challenging. In light of Dr. Awtar’s testimony and Petitioner’s patent applications,
`
`the bare assumption in the Petition that a POSITA would expect success in
`
`combining Shelton and Wallace is insufficient.
`
`II.
`
`PETITIONER’S PRIMARY COMBINATION DOES NOT DISCLOSE
`LIMITATION 24.3
`For the reasons discussed below, the Certificate of Correction is invalid and
`
`cannot apply in this proceeding. Petitioner has failed to show that limitation 24.3,
`
`as originally filed (“a tool mounting portion operably coupled to a distal end of said
`
`proximal spine portion”), is disclosed by the primary combination, and therefore the
`
`primary combination does not render obvious claim 24.
`
`A. The Certificate Of Correction Is Invalid And Does Not Apply In
`This Proceeding
`In litigation between the parties in the District of Delaware, Petitioner urged
`
`the District Court to invalidate the Certificate of Correction. The Court did so in an
`
`order issued on February 11, 2019. Ex. 2013. Ethicon has waived its right to appeal
`
`this decision. Ex. 2027. Accordingly, Petitioner is precluded by both collateral
`
`estoppel and judicial estoppel from now advocating that the Certificate should be
`
`3
`
`
`
`
`
`applied.1
`
`1.
`Collateral Estoppel Bars Application of the Certificate
`Collateral estoppel applies when an issue of fact or law is (1) “actually
`
`litigated and determined,” (2) “by a valid and final judgment,” and (3) “the
`
`determination is essential to the judgment.” Worlds Inc. v. Bungie, Inc., 903 F.3d
`
`1237, 1247 (Fed. Cir. 2018). Here, there is no dispute that the validity of the
`
`Certificate of Correction was actually litigated before and determined by the District
`
`of Delaware, and that the determination was essential to the Court’s order; indeed,
`
`the Court’s order was directed solely to the issue of the validity of the Certificate,
`
`and evidences that the issue was fully litigated to the Court through “the parties’
`
`claim construction briefing and joint status report.” Ex. 2013 at 1.
`
`
`1 Petitioner is also foreclosed from making any argument that the original claim
`
`language is defective or lacks support in the specification. Petitioner argued exactly
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`the opposite to the District of Delaware. Ex. 2023 at 4; Ex. 2024 at 1 (“As set forth
`
`in Intuitive’s opening papers,
`
`the as-printed original claim
`
`language
`
`is
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`typographically and grammatically correct, and reads logically in the context of the
`
`surrounding claim language, the specification, and the other claims of the ’969
`
`Patent.”).
`
`4
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`
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`
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`Petitioner, however, contends that “[i]ssue preclusion does not apply here
`
`because there is no final judgment from the District Court,” and argues that “Patent
`
`Owner has specifically reserved the right to appeal” the order. Reply at 3, 4. Ethicon,
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`however, has waived its right to appeal the Court’s decision. Ex. 2027. Thus, the
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`District Court’s decision invalidating the Certificate of Correction is sufficiently
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`“procedurally definite” to be deemed final for purposes of collateral estoppel
`
`because it cannot be modified or reversed on appeal. Restatement (Second) of
`
`Judgements § 13 (1982) (“The test of finality, however, is whether the conclusion in
`
`question is procedurally definite and not whether the court might have had doubts in
`
`reaching the decision.”). Accordingly, collateral estoppel applies to this issue,
`
`barring Petitioner from relitigating the question of whether the Certificate applies.
`
`2.
`Judicial Estoppel Bars Application Of The Certificate
`Judicial estoppel also bars Petitioner from now asserting that the Certificate
`
`applies. Judicial estoppel applies where (1) a party’s later position is “clearly
`
`inconsistent” with that party’s earlier litigation position; (2) “the party has succeeded
`
`in persuading a court to accept that party’s earlier position,” such that “judicial
`
`acceptance of an inconsistent position in a later proceeding would create the
`
`perception that either the first or the second court was misled”; and (3) “the party
`
`seeking to assert an inconsistent position would derive an unfair advantage or impose
`
`an unfair detriment on the opposing party if not estopped.” New Hampshire v.
`
`5
`
`
`
`
`
`Maine, 532 U.S. 742, 750-51 (2001). The purpose of the doctrine is to protect the
`
`integrity of the judicial process by prohibiting parties from deliberately changing
`
`positions according to the exigencies of the moment. Id. at 749-50. “Judicial
`
`estoppel applies just as much when one of the tribunals is an administrative agency
`
`as it does when both tribunals are courts.” Trustees in Bankr. Of N. Am. Rubber
`
`Thread Co. v. U.S., 593 F.3d 1346, 1354 (Fed. Cir. 2010).
`
`Here, all three elements of judicial estoppel are met. First, Petitioner’s
`
`position now – that the Board should apply the Certificate – is clearly inconsistent
`
`with its earlier positions before both the District of Delaware and the Board.
`
`Specifically, Petitioner expressly argued in its district court claim construction
`
`briefing that the Certificate “is invalid as a matter of law[.]” Ex. 2023 at 2. Likewise,
`
`Petitioner expressly told the Board in its Petition, in this very proceeding, that
`
`“Petitioner contends the Certificate was not effective.” Petition at 89. These
`
`unequivocal assertions that the Certificate is not applicable are clearly inconsistent
`
`with Petitioner’s new position that the Board should apply the Certificate in this
`
`proceeding. Second, Petitioner succeeded in persuading the District of Delaware to
`
`accept its earlier position that the Certificate is invalid, as evidenced by the Court’s
`
`order. Ex. 2013. In view of the District Court’s order, acceptance by the Board now
`
`that the Certificate is operative and in force for this proceeding would invariably
`
`create the perception that either the District Court or the Board was misled as to the
`
`6
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`
`
`
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`certificate’s validity. Finally, Petitioner would derive an unfair advantage over
`
`Ethicon if not estopped because Ethicon justifiably relied on Petitioner’s prior
`
`position and the District Court’s order in preparing its Patent Owner Response in
`
`this proceeding.
`
`Accordingly, the Board should apply judicial estoppel to bar Petitioner from
`
`asserting that the Certificate of Correction applies in this proceeding.
`
`B.
`
`Petitioner’s Primary Combination Does Not Disclose Limitation
`24.3 As Originally Issued
`Petitioner’s primary combination does not disclose limitation 24.3 as
`
`originally issued. As Ethicon explained in the Patent Owner Response (“POR”),
`
`the primary combination of Shelton’s endocutter with Giordano’s articulation
`
`joint 14 and articulation control 16 (collectively referred to in the Petition as
`
`“Giordano’s articulation mechanism”), the articulation joint is not operably
`
`coupled by proximate spine tube 46 (which Petitioner maps to the recited
`
`“proximal spine portion”) to anything on the robotic tool mounting portion of
`
`Wallace. POR at 17-20.
`
`In Reply, Petitioner attempts to circumvent this shortcoming in its
`
`obviousness theory by claiming that Patent Owner misstates the combination by
`
`asserting that Giordano’s articulation control 16 would remain in the
`
`combination. Reply at 6. According to Petitioner, its position all along has been
`
`that the primary combination features Giordano’s “articulation mechanism in the
`7
`
`
`
`
`
`tool mounting portion controlled by Wallace’s robotic system.” Id. Petitioner’s
`
`own citations to the Petition and Dr. Knodel’s declaration, however, plainly
`
`demonstrate that this is an improper attempt by Petitioner to substitute its
`
`original, flawed obviousness combination with a new theory of the combination
`
`for the first time on Reply.
`
`First, Petitioner cites pages 24-26 of the Petition and ¶¶ 50-55 of Dr.
`
`Knodel’s declaration. Reply at 6. These sections, however, only argue for
`
`certain specific components – Shelton’s second gear rack 142 and gear rack 100
`
`– to be moved from the device handle to Wallace’s robotic tool base. Petition at
`
`24-25 (discussing “removing the handle and triggers and connecting the ‘second
`
`gear rack 142’ of Shelton to one of the actuation gears 400 on the Wallace tool
`
`base and connecting the ‘gear rack 100’ of Shelton to another one of the
`
`actuation gears 400.”); Ex. 1005, ¶ 50 (same). Indeed, as the figure below from
`
`the Petition clearly shows, these passages from the Petition and Dr. Knodel only
`
`concerned components originally located in the handle of Shelton’s endocutter:
`
`8
`
`
`
`
`
`Petition at 25; see also Ex. 1005, ¶ 50 (same)
`By contrast, Giordano’s articulation control 16 is located on the elongated shaft of
`
`the endocutter, not in the handle, as shown in the annotated figure below from the
`
`Petition and Dr. Knodel’s declaration:
`
`
`
`9
`
`
`
`
`
`
`
`Petition at 82; Ex. 1005, ¶ 117 (same)
`Thus, pages 24-26 of the Petition and ¶¶ 50-55 of Dr. Knodel’s testimony do not
`
`support Petitioner’s position that Petitioner articulated a theory in which the
`
`articulation control 16 was replaced with control inputs in the tool mounting portion.
`
`Next, Petitioner cites pages 47-49 of the Petition and ¶ 80 of Dr. Knodel’s
`
`declaration. Reply at 6. But, like the previous citations, these sections argue for a
`
`specific component – Shelton’s rotation knob 60 – to be replaced by a helical tube
`
`gear on the robotic tool mounting portion. Petition at 48 (arguing that “the manually
`
`operated rotational knob would be replaced by the tube gear of Wallace”); Ex. 1005,
`
`¶ 80 (same). Indeed, these sections do not refer to Giordano’s articulation control
`
`16, which is not even depicted in the figure below that Petitioner used to illustrate
`
`the components at issue:
`
`10
`
`
`
`
`
`
`
`Petition at 48; see also Ex. 1005, ¶ 79 (same)
`Finally, Petitioner cites page 84 of the Petition and ¶ 121 of Dr. Knodel’s
`
`declaration. Reply at 6. These passages, however, which purport to offer
`
`motivations for the primary combination, actually confirm Ethicon’s position that
`
`Petitioner’s theory involved Giordano’s articulation joint 14 and articulation
`
`control 16. For example, both the Petition and Dr. Knodel state that the combination
`
`consists of “the Shelton stapler for use with Giordano’s articulation mechanism”
`
`(which the Petition defined on page 81 as including articulation control 16). Petition
`
`at 84; Ex. 1005, ¶ 121. Even when subsequently arguing that it would have been
`
`obvious to further adapt “the resulting device (i.e., the Shelton stapler with
`
`Giordano’s articulation mechanism)” for use with a robotic system, neither the
`
`11
`
`
`
`
`
`Petition nor Dr. Knodel ever refers to any modification of Giordano’s articulation
`
`control 16 to be replaced by some other component in the tool mounting portion, as
`
`Petitioner did with Shelton’s rotational knob 60, gear rack 100, and second gear rack
`
`142. Petition at 84; Ex. 1005, ¶ 121. Indeed, this is consistent with numerous other
`
`statements throughout the Petition, which Ethicon cited in the Patent Owner
`
`Response, that the primary combination consists of Shelton’s endocutter with
`
`Giordano’s articulation control 16, without modification to the latter. See POR at
`
`18-19 (citing Petition at 81, 85, 86-87).
`
`Thus, it is clear that the primary combination, as set forth in the Petition, did
`
`not include any modification to Giordano’s articulation control 16 to relocate its
`
`functions into Wallace’s tool mounting portion. Petitioner’s attempt on Reply to
`
`assert that the Giordano’s articulation control would be relocated to the tool
`
`mounting portion is an improper new argument that attempts to “embark in a new
`
`direction with a new approach as compared to positions taken in a prior filing,” and
`
`should be disregarded. August 2018 Trial Practice Guide Update at 15; 37 C.F.R. §
`
`42.23. Petitioner’s primary combination, as presented in the Petition (see Petition at
`
`90 citing Ex. 1005, ¶ 130), fails to disclose or render obvious limitation 24.3 because
`
`it does not include any operable coupling between tool mounting portion and the
`
`distal end of the proximal spine portion.
`
`12
`
`
`
`
`
`III. A POSITA WOULD NOT HAVE BEEN MOTIVATED TO MAKE
`PETITIONER’S ALTERNATIVE COMBINATION
`Ethicon explained in the Patent Owner Response that a POSITA would have
`
`been deterred from making Petitioner’s proposed “alternative combination” of
`
`Shelton with Wallace’s articulation mechanism because of incompatibilities that
`
`would result from the multi-axis articulation of Wallace’s wrist. POR at 21-27. In
`
`Reply, Petitioner argues for the first time that the alternative combination could have
`
`been formed with only a single axis of articulation, which purportedly avoids the
`
`issues Ethicon raised in the Patent Owner Response. Reply at 9-11, 12-15 (arguing
`
`at, e.g., page 13, that “a POSITA would have been motivated to use only one axis of
`
`articulation”).
`
`As an initial matter, this argument is newly raised for the first time on Reply
`
`and should be disregarded. The only discussion of Wallace’s articulation mechanism
`
`in the Petition describes Wallace as teaching “an articulation mechanism using gear-
`
`driven articulation rods allowing multi-axis 360 degree movement, which improves
`
`upon Giordano’s disclosure of movement along a single axis.” Petition at 85. Thus,
`
`the alternative combination as presented in the Petition expressly distinguishes
`
`Wallace’s disclosure from that of prior, single-axis articulation mechanisms, which
`
`is entirely inconsistent with Petitioner’s position on Reply that a POSITA would
`
`have implemented Wallace’s wrist with only a single axis of articulation.
`
`13
`
`
`
`
`
`Accordingly, Petitioner’s new Reply argument should be disregarded. August 2018
`
`Trial Practice Guide Update at 15; 37 C.F.R. § 42.23.
`
`Even if this new argument is not disregarded, it is unsupported by any
`
`motivation to combine. As noted above, Petitioner’s only discussion of the
`
`alternative combination is at page 85 of the Petition. There, the motivation offered
`
`for the combination is that Wallace’s wrist, with its “multi-axis 360 degree
`
`movement,” “improves upon Giordano’s disclosure of movement along a single
`
`axis.” Petition at 85. Thus, the sole motivation that Petitioner presented for
`
`combining Shelton’s endocutter with Wallace’s articulation mechanism was the
`
`benefit of having multi-axis articulation. The Petition presented no motivation for
`
`making the combination without multiple axes of articulation, and as such,
`
`Petitioner’s new Reply argument fails to show obviousness because it fails to
`
`establish any motivation to combine. Accordingly, the Board should find that
`
`Petitioner’s alternative combination fails to render any of the challenged claims
`
`obvious.
`
`IV. THE LOSS OF TACTILE FEEDBACK WOULD HAVE DETERRED A
`POSITA FROM ATTEMPTING EITHER THE PRIMARY
`COMBINATION OR THE ALTERNATIVE COMBINATION
`Petitioner’s primary and alternative combinations both rely on combining a
`
`handheld endocutter (Shelton) with a robotic tool mounting system (Wallace). In
`
`the Patent Owner Response, Ethicon set forth substantial evidence that (1) tactile
`
`14
`
`
`
`
`
`feedback was critical to the use of an endocutter; and (2) tactile feedback was not
`
`available for robotic systems as of the 969 Patent priority date. These factors would
`
`have deterred a POSITA from adapting a handheld endocutter such as Shelton for
`
`use with a robotic system such as Wallace. See Ex. 2005, ¶¶ 77-78, 102. Petitioner’s
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`reply arguments fail to rebut Ethicon’s evidence regarding the availability and
`
`importance of tactile feedback.
`
`Although Petitioner submitted a supplemental declaration from Dr. Knodel
`
`with its Reply (see Ex. 1009), Dr. Knodel fails to rebut Dr. Awtar’s testimony
`
`concerning the importance of tactile feedback. Specifically, Dr. Knodel’s
`
`supplemental declaration only purported to address two points relating to tactile
`
`feedback: (1) Petitioner’s claim that tactile feedback was disclosed in Wallace (Ex.
`
`1017, ¶¶ 4, 13-17), and (2) issues relating to tactile feedback in instruments with
`
`passive articulation (Ex. 1017, ¶¶ 6-12). The former does not relate to Dr. Awtar’s
`
`testimony concerning the importance of tactile feedback, and the latter relates to
`
`issues that are only relevant to Petitioner’s IPR2018-01247, which also challenges
`
`the 969 Patent.
`
`In any event, Petitioner’s reply evidence fails to support the assertions made
`
`by its attorneys regarding the availability of tactile feedback. First, Petitioner
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`incorrectly contends that tactile feedback would have been available for use with
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`Wallace’s robotic system, citing Wallace’s incorporation by reference of U.S. Patent
`
`15
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`
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`Appl. No. 08/975,617 (which issued as Cooper, Ex. 1018) and Tierney’s
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`incorporation by reference of PCT application WO98/25666 (the ’666 Application,
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`Ex. 1025), which is related to Cooper. Cooper and the ’666 Application, however,
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`do not actually disclose a tactile feedback system for a robotic surgical system.
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`Instead, both Cooper and the ’666 Application repeatedly state that components
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`required to incorporate a tactile feedback system (e.g., sensors) are not disclosed.
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`Ex. 1025 at 13:27-282 (“Cannula 66 may include a force sensing element (not
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`shown)….”), 17:10-12 (“Tool 62 will preferably include…a tactile sensor array
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`(not shown) for providing tactile feedback to the surgeon.”); see also id. at 7:24-
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`35, 8:19-23, 14:13-31; Ex. 1018 at 3:43-48 (“Position, force, and tactile feedback
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`sensors (not shown) may also be employed to transmit … sensations from the
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`surgical tools back to the surgeon’s hands as he/she operates the telerobotic
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`system”), 5:9-18 (same), 9:63-66 (“Drive motors 170 will preferably include …
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`force sensors (not shown) for transmitting force and torque feedback to the surgeon
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`S.”) (all emphasis added). At most, Cooper and the ’666 Application describe that
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`it would be preferable if a robotic system included the ability to provide tactile
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`feedback to the surgeon. Ex. 1025 at 11:33-37 (“Any suitable conventional or
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`2 Page/line citations to Ex. 1025 refer to the page numbers that Petitioner endorsed
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`onto the exhibit, not the originally printed page numbers.
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`specialized servomechanism may be used…with those incorporating force and
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`torque feedback being particularly preferred….”). Indeed, Dr. Knodel admitted
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`on cross-examination that Cooper “doesn’t tell you how to do” tactile feedback; it
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`only discloses that “you could do this.” Ex. 2025 at 41:2-13. Dr. Knodel also
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`admitted that in forming his supplemental opinions regarding tactile feedback, he
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`did not review Exhibit 2018, one of several pieces of evidence that Dr. Awtar cited
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`to show that the lack of tactile feedback was a major limitation of prior robotic
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`systems. Ex. 2025 at 25:7-26:5. Thus, Petitioner’s assertion that “a POSITA would
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`understand that Wallace (and the combination of Wallace and Tierney) discloses a
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`robotic system with tactile feedback” is contradicted by the very disclosures
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`Petitioner cites, as well as by Dr. Knodel’s deposition testimony. Reply at 8.
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`Critically, Petitioner’s proposed combinations do not provide the omitted
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`force or tactile sensors that Cooper and the ’666 Application state are necessary to
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`provide tactile feedback. As Petitioner itself admits, the primary and alternative
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`combinations both modify Shelton’s stapler for use with Wallace’s robotic system.
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`Reply at 1. Shelton’s stapler does not disclose any sensors for measuring tactile
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`feedback, nor does Petitioner contend that it does. This is, of course, because
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`Shelton’s stapler is handheld, and therefore the surgeon experiences tactile feedback
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`17
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`directly through his or her interaction with the closure and firing triggers.3 See, e.g.,
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`Ex. 2005, ¶ 41 (“Shelton also describes a handheld endocutter.”).
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`Second, Petitioner contends that the sales of its robotic endocutters
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`demonstrates that a POSITA would have known that tactile feedback was not critical
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`to the use of an endocutter. Reply at 15-16. This is not so. The design of Petitioner’s
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`first robotic endocutter, which was not commercially available until 2013, confirms
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`Patent Owner’s arguments that (1) a POSITA would have understood that tactile
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`feedback was not available for a robotic system; and (2) tactile feedback was critical
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`for an endocutter. In particular, the project manager for the development of
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`Petitioner’s endocutters testified in the co-pending litigation between the parties that
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`3 By proposing to convert Shelton’s handheld endocutter into a robotic endocutter,
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`Petitioner is proposing modifications that change the basic principles under which
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`Shelton’s endocutter is designed to operate. It is well-established that such
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`combinations may fail to support a conclusion of obviousness. Plas-Pak Indus., Inc.
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`v. Sulzer Mixpac AG, 600 F. App’x 755, 757-758 (Fed. Cir. 2015); Fisher & Paykel
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`Healthcare Ltd. v. ResMed Pty Ltd., IPR2017-00059, 2018 WL 1193320, at *18
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`(P.T.A.B. Mar. 7, 2018); Adidas AG v. Nike, Inc., IPR2016-00922, 2019 WL
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`764425, at *18 (P.T.A.B. Feb. 19, 2019).
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`Ex. 2026 at 120:19-121:9. Thus, rather than support Petitioner’s argument, the
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`design of Petitioner’s robotic endocutter confirms that tactile feedback was not
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`available in robotic systems (even as of 2013) and was known to be critical for an
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`endocutter because
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`4 SmartClamp is a software program that notifies the user when the jaws of the
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`stapler do not adequately close.
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` See https://www.intuitive.com/en-us/-
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`/media/Project/Intuitive-surgical/files/pdf/1008699-rev-c-
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`viewable.pdf?la=en&hash=4462DB29FD4AE2C7E946E1D56891C28D.
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`19
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`.
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`For the reasons discussed above, Petitioner’s argument and supplemental
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`expert declaration have failed to rebut Patent Owner’s evidence that (1) tactile
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`feedback was critical to the use of a endocutter; and (2) tactile feedback was not
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`available for robotic systems as of the priority date of the 969 Patent. Accordingly,
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`Patent Owner’s evidence, including the testimony of Dr. Awtar, demonstrates that
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`the loss of tactile feedback would have deterred a POSITA from combining Shelton
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`and Wallace. See also Polaris Inc. v. Arctic Cat, Inc., 882 F.3d 1056, 1069 (Fed.
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`Cir. 2018) (“[E]ven if a reference is not found to teach away, its statements regarding
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`preferences are relevant to a finding regarding whether a skilled artisan would be
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`motivated to combine….”).
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`V.
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`PETITIONER HAS FAILED TO DEMONSTRATE A REASONABLE
`EXPECTATION OF SUCCESS
`A.
`Petitioner’s Arguments Regarding the Capabilities of Tierney’s
`Robot Does not Demonstrate a Reasonable Expectation of Success
`Petitioner appears to contend that because Tierney’s robot (the disclosure of
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`which is allegedly incorporated by reference into Wallace) is presumptively capable
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`of providing sufficient force to power an endocutter, a POSITA would necessarily
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`have a reasonable expectation of success in adapting a handheld endocutter for use
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`with Tierney. Reply at 18-20. This is no