`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`INTUITIVE SURGICAL, INC.,
`Petitioner,
`
`v.
`
`ETHICON LLC,
`Patent Owner.
`______________________
`
`IPR2018-01247
`U.S. Patent No. 8,479,969
`______________________
`
`PATENT OWNER ETHICON LLC’S SUR-REPLY
`
`
`
`
`
`
`
`
`
`TABLE OF CONTENTS
`
`IPR2018-01247
`U.S. Patent No. 8,479,969
`
`I.
`
`INTRODUCTION ........................................................................................ 1
`
`II. GROUND 2, CLAIM 24: PETITIONER HAS NOT
`DEMONSTRATED THAT THE ANDERSON/TIMM
`COMBINATION RENDERS OBVIOUS LIMITATION [24.4] .............. 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
`
`The Petition’s Conclusory Analysis of Limitation [24.4] Failed
`to Meet Petitioner’s Prima Facie Burden ............................................. 7
`
`Section II.B of the Reply Raises New, Impermissible
`Arguments Concerning Limitation [24.4] That Should be
`Disregarded ........................................................................................... 8
`
`B.
`
`C.
`
`III. GROUND 2, CLAIM 24: A POSITA WOULD NOT HAVE
`UTILIZED TIMM’S PASSIVE ARTICULATION JOINT IN
`ANDERSON’S ROBOTIC SYSTEM ........................................................11
`
`A.
`
`B.
`
`Petitioner’s Combination Eliminates the Tactile Feedback That
`Is Critical to the Operation of Timm’s Endocutter and Changes
`the Design Principles of the Anderson/Timm Surgical Tools ............11
`
`Passively-Articulated Robotic Tools Have Not Been Introduced
`Even Today, Confirming That a POSITA Would Not Have
`Designed Such a Tool in 2011 ............................................................13
`
`C.
`
`Petitioner’s Counter-Arguments Are Unpersuasive ...........................13
`
`1.
`
`The Anderson/Timm combination does not disclose
`tactile feedback relating to forces applied to the exterior
`of the end effector .....................................................................14
`
`i
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`IPR2018-01247
`U.S. Patent No. 8,479,969
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`2.
`
`3.
`
`Petitioner’s argument that tactile feedback is not a
`requirement for use of passive articulation with a robotic
`system is meritless ....................................................................15
`
`Petitioner’s argument that a POSITA would have added
`tactile feedback to the Anderson/Timm combination is
`meritless ....................................................................................17
`
`IV. GROUND 2, CLAIM 24: A POSITA WOULD NOT HAVE HAD
`A REASONABLE EXPECTATION OF SUCCESS IN
`COMBINING ANDERSON’S TOOL BASE WITH TIMM’S
`HANDHELD ENDOCUTTER ...................................................................18
`
`A. Anderson Does Not Disclose a Drive System for a Surgical
`Instrument Capable of Driving an Endocutter ....................................18
`
`B.
`
`C.
`
`Expert Testimony Concerning Gears Does Not Demonstrate a
`Reasonable Expectation of Success ....................................................20
`
`Petitioner Fails To Rebut Evidence From Its Own Patent
`Applications .........................................................................................22
`
`V. GROUND 3: PETITIONER HAS NOT DEMONSTRATED
`THAT THE ANDERSON/TIMM/WALLACE COMBINATION
`RENDERS CLAIMS 25-26 OBVIOUS .....................................................23
`
`VI. GROUND 4: PETITIONER HAS NOT DEMONSTRATED
`THAT THE ANDERSON/KNODEL COMBINATION
`RENDERS CLAIMS 19-20 OBVIOUS .....................................................25
`
`VII. GROUND 5: PETITIONER HAS NOT DEMONSTRATED
`THAT THE ANDERSON/VIOLA COMBINATION RENDERS
`CLAIMS 21-22 OBVIOUS .........................................................................26
`
`VIII. CONCLUSION ............................................................................................27
`
`
`
`ii
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`IPR2018-01247
`U.S. Patent No. 8,479,969
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`TABLE OF AUTHORITIES
`
` Page(s)
`
`Cases
`Adidas AG v. Nike, Inc.,
`IPR2016-00922, 2019 WL 764425 (P.T.A.B. Feb. 19, 2019) ........................... 12
`Fisher & Paykel Healthcare Ltd. v. ResMed Pty Ltd.,
`IPR2017-00059, 2018 WL 1193320 (P.T.A.B. Mar. 7, 2018) ........................... 12
`Gillette Co. v. S.C. Johnson & Son, Inc.,
`919 F.2d 720 (Fed. Cir. 1990) ............................................................................ 24
`Harmonic Inc. v. Avid Tech., Inc.,
`815 F.3d 1356 (Fed. Cir. 2016) ............................................................................ 8
`Hynix Semiconductor Inc. v. Rambus Inc.,
`645 F.3d 1336 (Fed. Cir. 2011) .......................................................................... 24
`Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd.,
`821 F.3d 1359 (Fed. Cir. 2016) ............................................................................ 8
`New Hampshire v. Maine,
`532 U.S. 742 (2001) .............................................................................................. 5
`Plas-Pak Indus., Inc. v. Sulzer Mixpac AG,
`600 F. App’x 755 (Fed. Cir. 2015) ..................................................................... 12
`Samsung Elecs. Co. v. Elm 3DS Innovations,
`LLC, 925 F.3d 1373 (Fed. Cir. 2019) ................................................................. 25
`Schenck, A.G. v. Norton Corp.,
`713 F.2d 782 (Fed. Cir. 1983) ............................................................................ 21
`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
`
`iii
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`IPR2018-01247
`U.S. Patent No. 8,479,969
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`
`
`Other Authorities
`37 C.F.R. § 42.23(b) .................................................................................................. 8
`August 2018 Trial Practice Guide Update ................................................................. 8
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`iv
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`IPR2018-01247
`U.S. Patent No. 8,479,969
`
`EXHIBIT LIST FOR IPR2018-01247
`
`Description
` Exhibit #
`Ex. 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,
`2018)
`Ex. 2002 Patent Statutory Disclaimer for U.S. Patent No. 8,479,969 filed on
`October 15, 2018
`Ex. 2003 U.S. Patent No. 7,524,320
`
`Ex. 2004 U.S. Patent No. 7,473,258
`
`Ex. 2005
`
`[Reserved]
`
`Ex. 2006 Declaration of Dr. Shorya Awtar
`
`Ex. 2007 Declaration of Dr. Elliott Fegelman
`
`Ex. 2008 Additional excerpts from technology tutorial
`
`Ex. 2009 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)
`
`Ex. 2010 Deposition Transcript of Bryan Knodel, IPR2018-01247 (April 3,
`2019)
`
`Ex. 2011 Deposition Transcript of Bryan Knodel, IPR2018-01254 (April 4,
`2019)
`
`Ex. 2012 U.S. Patent No. 8,640,788
`
`Ex. 2013 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)
`
`Ex. 2014 WIPO Publication No. 2015/153642 A1
`
`Ex. 2015 U.S. Patent No. 8,186,555
`
`v
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`IPR2018-01247
`U.S. Patent No. 8,479,969
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`Description
`
` Exhibit #
`Ex. 2016 U.S. Patent No. 5,307,976
`Ex. 2017 Hermann Mayer et al., Haptic Feedback in a Telepresence System
`for Endoscopic Heart Surgery, Presence, Vol. 16, No. 5, pp. 459-
`470 (October 2007)
`Ex. 2018 Allison M. Okamura, Haptic feedback in robot-assisted minimally
`invasive surgery, Current Opinion in Urology, 19:102-107 (2009)
`
`Ex. 2019 U.S. Patent Application Publication No. 2012/0209314
`
`Ex. 2020 U.S. Patent No. 6,978,921
`
`Ex. 2021
`
`[Reserved]
`
`Ex. 2022
`
`[Reserved]
`
`Ex. 2023 Defendants’ Opening Claim Construction Brief, Ethicon v. Intuitive
`Surgical, Inc., C.A. 17-871, D.I. 116 (D. Del. June 28, 2018)
`
`Ex. 2024 Defendants’ Responsive Claim Construction Brief, Ethicon v.
`Intuitive Surgical, Inc., C.A. 17-871, D.I. 127 (D. Del. Aug. 1,
`2018)
`
`Ex. 2025 Deposition of Dr. Bryan Knodel in IPR2018-01247 and IPR2018-
`01254 (August 12, 2019)
`
`Ex. 2026
`
`[Reserved]
`
`Ex. 2027 Notice of Waiver of Appeal Regarding the Court’s Order
`Invalidating the January 2018 Certificate of Correction Relating to
`U.S. Patent No. 8,479,969, Ethicon v. Intuitive Surgical, Inc., C.A.
`17-871, D.I. 311 (D. Del.)
`
`vi
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`
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`I.
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`IPR2018-01247
`U.S. Patent No. 8,479,969
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`INTRODUCTION
`Patent Owner’s Response (“POR”) provided multiple, independent reasons
`
`why Petitioner’s unpatentability grounds should be denied. Petitioner’s reply
`
`arguments fail to remedy the Petition’s deficiencies.
`
`For Grounds 2-3, the single, conclusory sentence in the Petition and
`
`supporting expert declaration failed to demonstrate that the Anderson/Timm
`
`combination discloses limitation [24.4] as originally filed (“a tool mounting
`
`portion operably coupled to a distal end of said proximal spine portion”).
`
`Recognizing this failure of proof, Petitioner erroneously urges the Board to apply
`
`the Certificate of Correction to limitation [24.4] in these proceedings. However,
`
`the District of Delaware invalidated this certificate 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
`
`certificate’s applicability. Furthermore, Petitioner’s Reply raises an entirely new
`
`argument to attempt to meet its burden that the primary combination discloses
`
`limitation [24.4] as originally filed. But the new arguments are contradicted by
`
`Petitioner’s own characterization of the primary combination in the Petition and its
`
`expert declaration.
`
`The POR also conclusively established for Grounds 2-3 that a POSITA
`
`would not have utilized a passive articulation joint in a robotic endocutter because
`
`1
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`
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`robotic surgical tools lack the tactile feedback that is necessary to perform passive
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`IPR2018-01247
`U.S. Patent No. 8,479,969
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`articulation safely and effectively. Petitioner’s Reply and supplemental declaration
`
`from Dr. Knodel fail to rebut this argument. First, Dr. Knodel agreed that tactile
`
`feedback for passive articulation was not disclosed in the prior art. Second, Dr.
`
`Knodel’s conclusory testimony that tactile feedback is not needed for passive
`
`articulation cannot outweigh the testimony of Dr. Fegelman, who unlike Dr.
`
`Knodel, actually has experience with the use of both (1) passively-articulated
`
`handheld tools and (2) robotic tools. Finally, Petitioner has no response to the
`
`testimony of Dr. Fegelman that using passive articulation would take away
`
`complete control of the device from a surgeon, negating the key perceived benefit
`
`of a robotic tool.
`
`Also, for Grounds 2-3, Petitioner has not demonstrated that a POSITA
`
`would have had a reasonable expectation of success combining Anderson and
`
`Timm. Petitioner has assumed that a POSITA would have been able to design a
`
`new instrument drive system to provide power from Anderson’s robot to Timm’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 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
`
`2
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`
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`
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`with a robotic system was extremely challenging. In light of Dr. Awtar’s testimony
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`IPR2018-01247
`U.S. Patent No. 8,479,969
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`and Petitioner’s patent applications, the bare assumption in the Petition that a
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`POSITA would expect success in combining Anderson and Timm is insufficient.
`
`Finally, Petitioner’s specific Reply arguments concerning Ground 3 and its
`
`Reply arguments concerning Grounds 4-5 fail to remedy the deficiencies identified
`
`in the POR.
`
`Accordingly, for the reasons set forth in the POR and this Sur-Reply, Patent
`
`Owner respectfully submits that Petitioner has failed to demonstrate that the
`
`challenged claims are obvious.
`
`II. GROUND 2, CLAIM 24: PETITIONER HAS NOT DEMONSTRATED
`THAT THE ANDERSON/TIMM COMBINATION RENDERS
`OBVIOUS LIMITATION [24.4]
`The Certificate of Correction is invalid and cannot apply in this proceeding.
`
`As explained below, Petitioner has failed to show that limitation [24.4], as
`
`originally filed, is disclosed by the Anderson/Timm combination.
`
`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 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
`
`3
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`
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`decision. Ex. 2027. Accordingly, Petitioner is precluded by both collateral estoppel
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`IPR2018-01247
`U.S. Patent No. 8,479,969
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`and judicial estoppel from now advocating that the Certificate should be applied.1
`
`Collateral estoppel bars application of the Certificate
`1.
`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
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`1237, 1247 (Fed. Cir. 2018). Here, there is no dispute that the validity of the
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`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
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`Certificate, and evidences that the issue was fully litigated to the Court through
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`“the parties’ claim construction briefing and joint status report.” Ex. 2013, p.1.
`
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`1 Petitioner is also foreclosed from arguing that the original claim language is
`
`defective or lacks support in the specification. Petitioner argued exactly the
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`opposite to the District of Delaware. Ex. 2023, p.4; Ex. 2024, p.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
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`surrounding claim language, the specification, and the other claims of the ’969
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`Patent.”).
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`4
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`Petitioner, however, contends that “[i]ssue preclusion does not apply here
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`
`
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`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, p.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
`
`Judgments § 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.
`
`Judicial estoppel bars application of the Certificate
`2.
`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
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`party seeking to assert an inconsistent position would derive an unfair advantage or
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`impose an unfair detriment on the opposing party if not estopped.” New Hampshire
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`5
`
`
`
`
`
`v. Maine, 532 U.S. 742, 750-51 (2001). The purpose of the doctrine is to protect
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`IPR2018-01247
`U.S. Patent No. 8,479,969
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`the integrity of the judicial process by prohibiting parties from deliberately
`
`changing positions according to the exigencies of the moment. Id., 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
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`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, p.2. Likewise,
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`Petitioner expressly told the Board in its Petition, in this very proceeding, that
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`“Petitioner contends the Certificate was not effective.” Petition, p.51, n.3. These
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`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
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`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
`
`6
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`
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`misled as to the Certificate’s validity. Finally, Petitioner would derive an unfair
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`U.S. Patent No. 8,479,969
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`advantage over Ethicon if not estopped because Ethicon justifiably relied on
`
`Petitioner’s prior position and the District Court’s order in preparing its POR in
`
`this proceeding.
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`Accordingly, the Board should apply judicial estoppel to bar Petitioner from
`
`asserting that the Certificate of Correction applies in this proceeding.
`
`B.
`
`The Petition’s Conclusory Analysis of Limitation [24.4] Failed to
`Meet Petitioner’s Prima Facie Burden
`The Petition fails entirely to explain how this limitation is met in the
`
`Anderson/Timm combination. POR, p.25-28. Petitioner’s analysis in the Petition is
`
`reproduced below:
`
`If the January 23, 2018 Certificate of Correction is not
`effective, then Anderson in view of Timm still discloses
`this
`limitation. IS1004, ¶105. Specifically,
`in
`the
`combination, Anderson’s tool mounting portion would be
`operably coupled to the distal end of the proximal spine
`portion of Timm’s shaft assembly via the structure of the
`distal spine portion itself.
`
`Petition, p.52; see also Ex. 1004, ¶104 (same conclusory assertion, except stating
`
`“via the proximal spine portion itself” instead of “via the structure of the distal
`
`spine portion itself”). This conclusory assertion that the combination discloses an
`
`operable coupling between the tool mounting portion and the distal end of the
`
`7
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`
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`proximal spine portion as required by limitation [24.4] does not satisfy Petitioner’s
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`U.S. Patent No. 8,479,969
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`prima facie burden to demonstrate obviousness. Harmonic Inc. v. Avid Tech., Inc.,
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`815 F.3d 1356, 1363-64 (Fed. Cir. 2016).
`
`C.
`
`Section II.B of the Reply Raises New, Impermissible Arguments
`Concerning Limitation [24.4] That Should be Disregarded
`Section II.B of Petitioner’s Reply attempts to overcome the Petition’s
`
`deficiencies by asserting new arguments that were not previously disclosed in the
`
`Petition and should be disregarded. Notably, this section does not cite a single
`
`sentence in the Petition. Petitioner attempts to stitch together several unrelated
`
`statements from Dr. Knodel’s declaration to fill the Petition’s gaps. But none of
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`these statements are cited in the Petition’s analysis of limitation [24.4]’s
`
`uncorrected language. Petition, p.51-52 (citing only paragraph 105, and not
`
`paragraph 104 as may have been intended, of Dr. Knodel’s declaration).
`
`Petitioner’s scattershot citations only confirm that the arguments in Section II.B
`
`should be struck as an improper attempt to substitute Petitioner’s original, flawed
`
`analysis with a new theory for the first time on Reply. Intelligent Bio-Systems, Inc.
`
`v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369-70 (Fed. Cir. 2016) (“[T]he
`
`Board did not err in refusing the reply brief as improper under 37 C.F.R. § 42.23(b)
`
`because IBS relied on an entirely new rationale to explain why [a POSITA] would
`
`have been motivated to combine [the prior art].”); August 2018 Trial Practice
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`8
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`
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`Guide Update, p.14-15 (“Examples of new issues are new theories or arguments
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`IPR2018-01247
`U.S. Patent No. 8,479,969
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`necessary to make out petitioner’s case-in-chief ….”).
`
`First, Petitioner states that “Dr. Knodel explained that the ‘tool mounting
`
`portion’ of Anderson was ‘base 34.’” Reply, p.5 (citing Ex. 1004, ¶63). Paragraph
`
`63 of Dr. Knodel’s declaration is an analysis of claim 23, not claim 24. This
`
`paragraph is not cited in the Petition’s section regarding the uncorrected language
`
`of [24.4].
`
`Second, Petitioner argues that “[i]n the Anderson/Timm combination, the
`
`shaft and end effector of Anderson is replaced with the shaft and end effector of
`
`Timm. Dr. Knodel refers to FIG. 1 of Timm, which shows ‘a surgical stapler with
`
`an articulation joint.’” Reply, p.6 (citing Ex. 1004, ¶36). Paragraph 36 of Dr.
`
`Knodel’s declaration is a background discussion of the Timm reference, does not
`
`concern an analysis of claim 24, and is not cited in the Petition’s section regarding
`
`the uncorrected language of [24.4].
`
`Third, Petitioner argues that “Dr. Knodel further identified a ‘lockable
`
`articulation joint’ at the distal end of the proximal spine portion, citing to Timm,
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`31:62-32:31.” Reply, p.7-8 (citing Ex. 1004, ¶¶36, 89). As noted above, paragraph
`
`36 is a background discussion of Timm, and paragraph 89 is a discussion of a
`
`different claim 24 limitation ([24.2]). Neither of these paragraphs is cited in the
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`Petition’s section regarding the uncorrected language of [24.4].
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`9
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`IPR2018-01247
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`Fourth, Petitioner argues that “the cable that locks the joint from the handle
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`
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`undeniably operably couples the handle to the articulation joint, and in the
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`combination, the handle becomes the tool mounting portion.” Reply, p.8-9. This is
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`neither in the Petition nor Dr. Knodel’s declaration.
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`Finally,2 Petitioner concludes that “the Anderson/Timm combination
`
`discloses a tool mounting portion coupled to the distal end of a proximal spine
`
`portion because (i) the Anderson/Timm articulation joint is disposed at the distal
`
`end of the proximal spine portion, and (ii) the Anderson/Timm tool mounting
`
`portion is used to articulate (by pressing distal end of the instrument against
`
`another instrument or nearby anatomy) and is used to lock the joint.” Reply, p.9-
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`10. Petitioner cites to neither the Petition nor Dr. Knodel’s declaration.
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`Not one of these arguments was included in the Petition’s analysis of the
`
`uncorrected language of [24.4]. Petition, p.51-52. Petitioner’s attempt at a do over
`
`should be rejected.
`
`
`2 Petitioner interposes its contention that the 969 Patent was not the first to disclose
`
`active articulation. Reply, p.9. This is irrelevant.
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`10
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`IPR2018-01247
`U.S. Patent No. 8,479,969
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`
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`III. GROUND 2, CLAIM 24: A POSITA WOULD NOT HAVE UTILIZED
`TIMM’S PASSIVE ARTICULATION JOINT IN ANDERSON’S
`ROBOTIC SYSTEM
`Petitioner’s Combination Eliminates the Tactile Feedback That Is
`A.
`Critical to the Operation of Timm’s Endocutter and Changes the
`Design Principles of the Anderson/Timm Surgical Tools
`A POSITA would not have been motivated to combine a robotic system with
`
`Timm’s passively-articulated endocutter. POR, p.28-31. By proposing to convert
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`Timm’s passively-articulated 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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`Timm’s handheld endocutter is designed to operate. As Dr. Fegelman explained, a
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`surgeon’s grip on a hand-held endocutter is critical to the use of passive
`
`articulation. See Ex. 2007, ¶19 (“Thus, the tactile feedback provided through the
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`surgeon’s grip on the hand-held portion is critical to the use of passive
`
`articulation.”)3; see also id., ¶22.
`
`Moreover, Dr. Fegelman’s testimony is that “from a surgeon’s perspective in
`
`the 2011 timeframe, one of the key perceived benefits of a robotic tool was the
`
`ability to have complete control over the movement of the tool from the surgeon
`
`console. Passive articulation relinquishes this control and instead requires external
`
`forces to control the movement of the tool. As a result, passive articulation would
`
`
`3 All emphasis added unless otherwise noted.
`
`11
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`negate this key perceived benefit of robotic surgery tools.” Ex. 2007, ¶25.
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`IPR2018-01247
`U.S. Patent No. 8,479,969
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`Intuitive’s argument that the surgeon would still have complete control because the
`
`surgeon would be pressing one tool against the other (Reply, p.13, n.1 (citing Ex.
`
`1017, ¶9)) misses the point because the surgeon is not directly controlling the
`
`articulation of the tool in this situation. Moreover, unlike Dr. Fegelman, Dr.
`
`Knodel admittedly has essentially no experience with passively articulating tools
`
`and has never discussed the issue with surgeons. Ex. 2025, p.20:22-22:24. Thus,
`
`Dr. Knodel’s unsupported assertions cannot overcome the testimony of Dr.
`
`Fegelman. The Anderson/Timm combination therefore also changes the
`
`fundamental operating principle of Anderson’s robotic tools by creating a situation
`
`where the surgeon does not directly control the tool’s movement. It is well-
`
`established that combinations that change the fundamental design principle may
`
`fail to support a conclusion of obviousness. Plas-Pak Indus., Inc. v. Sulzer Mixpac
`
`AG, 600 F. App’x 755, 757-758 (Fed. Cir. 2015); Fisher & Paykel Healthcare Ltd.
`
`v. ResMed Pty Ltd., IPR2017-00059, 2018 WL 1193320 (P.T.A.B. Mar. 7, 2018);
`
`Adidas AG v. Nike, Inc., IPR2016-00922, 2019 WL 764425 (P.T.A.B. Feb. 19,
`
`2019).
`
`12
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`IPR2018-01247
`U.S. Patent No. 8,479,969
`
`B.
`
`Passively-Articulated Robotic Tools Have Not Been Introduced
`Even Today, Confirming That a POSITA Would Not Have
`Designed Such a Tool in 2011
`Petitioner has not disputed Dr. Fegelman’s testimony that he is unaware of
`
`any passively articulating robotic tools in the past or even today. Ex. 2007, ¶21;
`
`Ex. 2025, p.22:23-25 (Dr. Knodel testifying that he has never seen a passively-
`
`articulated robotic tool). Intuitive’s robotic system was FDA-approved in 2000 (see
`
`https://www.intuitive.com/en-us/about-us/company).
`
`Intuitive, however, has never introduced a passively-articulated robotic tool.
`
`This confirms Patent Owner’s position, as supported by Dr. Awtar and Dr.
`
`Fegelman, that a POSITA would not have found a passively-articulated robotic
`
`tool to be clinically acceptable. POR, p.29-31; Ex. 2006, ¶¶73-76; Ex. 2007, ¶¶22-
`
`26.
`
`Petitioner’s Counter-Arguments Are Unpersuasive
`C.
`Faced with compelling evidence that a POSITA would not have made the
`
`proposed combination, Petitioner argues that (1) “there is no credible evidence that
`
`‘tactile feedback is required”; and (2) “the Anderson/Timm combination has tactile
`
`feedback.” Both arguments are meritless and are addressed in reverse order.
`
`13
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`
`
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`IPR2018-01247
`U.S. Patent No. 8,479,969
`
`1.
`
`The Anderson/Timm combination does not disclose tactile
`feedback relating to forces applied to the exterior of the end
`effector
`Petitioner argues that Anderson discloses tactile feedback. Reply, p.11-12.
`
`However, the tactile feedback that is necessary to perform passive articulation
`
`requires detecting the forces that are applied to the exterior of the end effector. See,
`
`e.g., POR, p.29 (“Dr. Fegelman explains that passive articulation requires pressing
`
`the exterior of the end effector of a surgical tool against another structure. Ex.
`
`2007, ¶17.”). Petitioner’s expert confirmed that the prior art does not disclose this
`
`type of tactile feedback in a robotic system. Ex. 2025, p.34:6-9 (“[A]re you aware
`
`of any prior art that describes a system for feedback associated with a passive
`
`articulating tool? A. []I’m not aware of that, no.”).
`
`a.
`
`The 969 Patent does not disclose tactile feedback for
`passive articulation
`Petitioner cites the 969 Patent at 67:35-36 and 86:30-32 for its disclosure
`
`that “video feedback is provided by the stereo display and tactile feedback is
`
`provided to the controllers grasped by the surgeon.” Reply, p.11. This disclosure
`
`has nothing to do with passive articulation, which Dr. Knodel confirmed at
`
`deposition. See Ex. 2025, p.17:8-18:6.
`
`14
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`IPR2018-01247
`U.S. Patent No. 8,479,969
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`b.
`
`Anderson does not disclose tactile feedback for passive
`articulation
`Petitioner cites Anderson at 6:33-37, which relates to an embodiment that
`
`includes a motor pack on the surgical instrument that may include “feedback
`
`sensors … [that] may transmit feedback or sensor signals to the robotic surgical
`
`system via the interface.” Reply, p.11-12 (citing Ex. 1017, ¶¶13-15). Dr. Knodel
`
`confirmed at deposition that these disclosures do not concern tactile feedback for
`
`passive articulation. See Ex. 2025, p.26:7-27:2, p.33:23-34:9.
`
`2.
`
`Petitioner’s argument that tactile feedback is not a
`requirement for use of passive articulation with a robotic
`system is meritless
`Petitioner contends that there are situations under which tactile feedback is
`
`not required for performing passive articulation, e.g., when pressing against
`
`another surgical instrument or when a “skilled” surgeon presses a tool against a
`
`“resilient” body structure.4 Reply, p.12-13. Petitioner’s only support is its expert’s
`
`ipse dixit. See Ex. 1017, ¶¶7-11. Dr. Knodel admittedly has essentially no
`
`experience with passive articulation and has never discussed the issue with
`
`surgeons. Ex. 2025, p.20:22-22:24. Petitioner’s arguments based on Dr. Knodel’s
`
`
`4 Notably, Dr. Knodel “agree[s] that passive articulation against a structure in the
`
`body raises concerns of damaging tissue due to excessive force.” Ex. 1017, ¶7.
`
`15
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`
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`opinions are thus entitled to no weight. Moreover, to the extent Petitioner contends
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`IPR2018-01247
`U.S. Patent No. 8,479,969
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`that Patent Owner conceded that there is no safety risk when performing passive
`
`articulation against another instrument, this is wrong. Dr. Fegelman, who unlike
`
`Dr. Knodel does have experience with both (1) handheld, passively-articulating
`
`tools and (2) robotic tools, did not opine that it would be clinically acceptable for a
`
`surgeon to perform passive articulation against another tool without tactile
`
`feedback. Instead, Dr. Fegelman explained that tactile feedback is necessary “to
`
`prevent damage to both the surgical tool itself as well as the structure that is
`
`providing the articulation force.” Ex. 2007, ¶22. The risk of damage to the
`
`surgical tool is present regardless of the structure against which the tool is
`
`articulated.
`
`Second, Petitioner cites a patent application that Patent Owner filed in 2012
`
`that allegedly discloses a passively-articulated robotic tool. Reply, p.13-14. This
`
`reference is not prior art and is thus not relevant to the issue of whether a POSITA
`
`would have combined Timm’s passively-articulated endocutter with Anderson.5
`
`Finally, Petitioner cites Dr. Awtar’s testimony where he stated that “I am not
`
`making the statement at all that there is no surgeon in 2011 who would have found
`
`
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