`
`Frederick E. Shelton, IV
`In re Patent of:
`8,479,969
`
`
`U.S. Pat. No.:
`July 9, 2013
`Issue Date:
`Appl. Serial No.: 13/369,609
`Filing Date:
`Feb. 9, 2012
`Title:
`DRIVE INTERFACE FOR OPERABLY COUPLING A
`MANIPULATABLE SURGICAL TOOL TO A ROBOT
`
`Attorney Docket No.: 11030-0049IPA
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,479,969
`PURSUANT TO 35 U.S.C. §§ 311–319, 37 C.F.R. § 42
`
`
`
`
`
`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`TABLE OF CONTENTS
`
`I.
`INTRODUCTION ......................................................................................... 1
`II. MANDATORY NOTICES UNDER 37 C.F.R § 42.8 ................................. 6
`A. Real Parties-In-Interest Under 37 C.F.R. § 42.8(b)(1) ............................... 6
`B. Related Matters Under 37 C.F.R. § 42.8(b)(2) ........................................... 6
`C. Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3) ...................... 6
`D. Service Information .................................................................................... 6
`III. PAYMENT OF FEES – 37 C.F.R. § 42.103 ................................................ 7
`IV. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104 ....................... 7
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a) .................................. 7
`B. Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested ................. 7
`SUMMARY OF THE ’969 PATENT .......................................................... 8
`V.
`VI. PROSECUTION HISTORY ...................................................................... 10
`VII. PRIORITY DATE ....................................................................................... 11
`VIII. CLAIM CONSTRUCTION UNDER 37 C.F.R. §§ 42.104(B)(3) ............ 12
`IX. SUMMARY OF THE PRIOR ART .......................................................... 12
`A. Giordano ................................................................................................... 12
`B. Shelton ...................................................................................................... 14
`C. Wallace ..................................................................................................... 16
`D. Tierney ...................................................................................................... 18
`THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST
`ONE CLAIM OF THE ’969 PATENT IS UNPATENTABLE ............... 18
`A. Ground 1: Claims 1-11 and 24 Would Have Been Obvious Over
`Giordano in View of Wallace ................................................................... 20
`B. Ground 2: Claims 1-11 and 24 Would Have Been Obvious Over
`Giordano in View of Wallace and Further in View of Tierney ............... 90
`C. Ground 3: Claims 1-6 and 9-10 Would Have Been Obvious Over
`Shelton in View of Wallace and Tierney ................................................. 91
`
`X.
`
`i
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`
`
`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`D. Ground 4: Claims 7, 8, 11, and 24 Would Have Been Obvious
`Over Shelton in View of Giordano and Further in View of Wallace
`and Tierney ............................................................................................... 92
`E. Ground 5: Claims 5 and 6 Would Have Been Obvious Over
`Giordano in View of Wallace and Tierney, and Further in View of
`Hueil ......................................................................................................... 93
`XI. CONCLUSION ............................................................................................ 96
`
`
`ii
`
`
`
`
`
`
`
`
`
`IS1001
`
`IS1002
`
`IS1003
`
`IS1004
`
`IS1005
`
`IS1006
`
`IS1007
`
`IS1008
`
`IS1009
`
`IS1010
`
`IS1011
`
`IS1012
`
`IS1013
`
`IS1014
`
`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`
`EXHIBITS
`
`U.S. Pat. No. 8,479,969 to Shelton, IV (“the ’969 Patent”)
`
`Prosecution History of the ’969 Patent (Serial No. 13/369,609)
`
`Reserved
`
`Reserved
`
`Declaration of Dr. Bryan Knodel (Giordano as Primary
`Reference)
`
`Reserved
`
`Reserved
`
`U.S. Patent No. 6,699,235 to Wallace et al. (“Wallace”)
`
`U.S. Patent No. 6,331,181 to Tierney et al. (“Tierney”)
`
`Reserved
`
`Reserved
`
`Reserved
`
`Reserved
`
`U.S. Patent App. No. 2008/0167672 to Giordano et al.
`
`(“Giordano”)
`
`IS1015
`
`U.S. Patent No. 6,978,921 to Shelton et al. (“Shelton”)
`
`iii
`
`
`
`IS1016
`
`
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`U.S. Patent App. No. 2007/0158385 to Hueil et al. (“Hueil”)
`
`iv
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`
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`
`I.
`
`INTRODUCTION
`Intuitive Surgical, Inc. (“Petitioner”) petitions for Inter Partes Review
`
`(“IPR”) of claims 1-11 and 24 of U.S. Patent 8,479,969 (“the ’969 Patent”). The
`
`’969 Patent is entitled “Drive Interface for Operably Coupling a Manipulatable
`
`Surgical Tool to a Robot.” Robotic surgical systems were known in the prior art,
`
`and likewise, surgical tools that interface with robotic surgical systems were
`
`known in the prior art. In fact, the ’969 Patent incorporates by reference1, and
`
`largely copies, the prior art robotic systems of Petitioner, which include drive
`
`interfaces to couple a manipulatable surgical tool to the robot:
`
`[T]he tool arrangement described above may be well-suited for use with
`those robotic systems manufactured by Intuitive Surgical, Inc. of
`Sunnyvale, Calif., U.S.A., many of which may be described in detail in
`various patents incorporated herein by reference. The unique and novel
`aspects of various embodiments of the present invention serve to utilize
`the rotary output motions supplied by the robotic system to generate
`specific control motions….
`IS1001 at 31:56-59.2
`
`The ’969 Patent does no more than adapt prior art surgical instruments to the
`
`
`1 See IS1001, 23:35-37, incorporating by reference U.S. Pat. No. 7,524,320, which
`
`is a continuation of a division of the application that issued as the Tierney patent
`
`(IS1009).
`
`2 Emphasis added throughout unless otherwise stated.
`
`1
`
`
`
`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`prior art robotic surgical systems of Petitioner—and it does so using the teachings
`
`of Petitioner’s own prior art, such as the “Tierney” patent (IS1009). Such is the
`
`epitome of obviousness.
`
`Not surprisingly, the robotic surgical system described in the ’969 Patent is
`
`uncannily similar to the prior art robotic surgical system described in Petitioner’s
`
`Tierney patent:
`
`’969 Patent
`
`Tierney Prior Art
`
`Robotic Controller
`
`
`
`2
`
`
`
`’969 Patent
`
`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`Tierney Prior Art
`
`Robotic Manipulator
`
`
`
`
`
`Surgical Tool With Proximal Tool Holder
`
`
`
`3
`
`
`
`’969 Patent
`
`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`Tierney Prior Art
`
`Tool Drive Assembly
`
`
`
`
`
`
`Not only were Petitioner’s robotic systems in the prior art, but the surgical
`
`instruments described in the ’969 Patent were likewise in the prior art.
`
`Specifically, the ’969 Patent adapts for robotic use handheld surgical instruments
`
`that were already disclosed in the published grandparent application to the ’969
`
`Patent, namely, U.S. Patent App. No. 2008/0167672 to Giordano et al.
`
`(“Giordano”). IS1014. The Giordano reference is 102(b) prior art to the claims of
`
`the ’969 Patent. For example, FIGs.1-22 of Giordano are essentially identical to
`
`FIGs. 1-22 of the ’969 Patent. The stapler in those figures uses a gear-driven firing
`
`4
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`
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`mechanism and a lever-driven closure tube assembly. In addition, Giordano
`
`incorporates by reference, and therefore discloses, another prior art stapler from
`
`U.S. Patent No. 6,978,921 to Shelton. The Shelton stapler uses both a gear-driven
`
`firing mechanism and a gear-driven closure tube assembly.
`
`As shown in this petition, it would have been obvious to a POSITA to adapt
`
`prior art handheld surgical instruments, such as the surgical staplers disclosed by
`
`Giordano (including the incorporated Shelton stapler), for use with a surgical
`
`robot, such as Petitioner’s prior art surgical robot disclosed by Wallace (which
`
`incorporates Tierney by reference). IS1008, 1:10-12, 16-18, 3:8-29.
`
`A POSITA would have readily combined the robots of Wallace/Tierney with
`
`the handheld instruments of Giordano/Shelton. In fact, Giordano (via
`
`incorporation of Shelton) specifically teaches that “the closing and firing motions
`
`[of Shelton’s handheld surgical stapler] may be generated by automated means.”
`
`IS1015, 9:47-50; see also 12:45-53. And Wallace (via incorporation of Tierney)
`
`specifically teaches that “[o]ne or more of the robotic arms [in Petitioner’s surgical
`
`robot] will often support a surgical tool which may be articulated (such as . . .
`
`staple appliers . . . or the like) . . . .” IS1009, 6:20-28.
`
`In this petition, Petitioner demonstrates that Giordano in view of Wallace,
`
`and/or Giordano in view of Wallace and further in view of the prior art they
`
`incorporate by reference and others, renders the challenged claims invalid for
`
`5
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`
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`obviousness. Petitioner therefore requests IPR of the challenged claims on
`
`Grounds 1-5 below.
`
`II. MANDATORY NOTICES UNDER 37 C.F.R § 42.8
`A. Real Parties-In-Interest Under 37 C.F.R. § 42.8(b)(1)
`Intuitive Surgical, Inc. is the real party-in-interest. No other party had
`
`access to the Petition, and no other party had any control over, or contributed to
`
`any funding of, the preparation or filing of the present Petition.
`
`B. Related Matters Under 37 C.F.R. § 42.8(b)(2)
`The ’969 Patent is the subject of Civil Action No. 1:17-cv-00871-LPS, filed
`
`on June 30, 2017, in the United States District Court for the District of Delaware.
`
`Concurrently with this petition, Petitioner is filing two more IPR petitions related
`
`to the ’969 Patent directed to different sets of claims, different statutory bases,
`
`and/or different primary references.
`
`C. Lead And Back-Up Counsel Under 37 C.F.R. § 42.8(b)(3)
`Petitioner provides the following designation of counsel.
`
`LEAD COUNSEL
`Steven R. Katz, Reg. No. 43,706
`3200 RBC Plaza, 60 South Sixth Street
`Minneapolis, MN 55402
`Tel: 617-542-5070 / Fax: 877-769-7945
`
`BACK-UP COUNSEL
`John C. Phillips, Reg. No. 35,322
`Tel: 858-678-5070
`Ryan P. O’Connor, Reg. No. 60,254
`Tel: 858-678-5070
`
`D.
`Service Information
`Please address all correspondence to the address above. Petitioner consents
`
`6
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`
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`to electronic service by email at IPR11030-0049IPA@fr.com (referencing No.
`
`11030-0049IPA and cc’ing PTABInbound@fr.com, katz@fr.com,
`
`phillips@fr.com, and oconnor@fr.com).
`
`III. PAYMENT OF FEES – 37 C.F.R. § 42.103
`Petitioner authorizes the Office to charge Deposit Account No. 06-1050 for
`
`the petition fee set in 37 C.F.R. § 42.15(a) and for any other required fees.
`
`IV. REQUIREMENTS FOR IPR UNDER 37 C.F.R. § 42.104
`A. Grounds for Standing Under 37 C.F.R. § 42.104(a)
`Petitioner certifies that the ’969 Patent is available for IPR, and Petitioner is
`
`not barred or estopped from requesting IPR.
`
`B. Challenge Under 37 C.F.R. § 42.104(b) and Relief Requested
`Petitioner requests IPR of claims 1-11 and 24 of the ’969 Patent on the
`
`grounds listed below. A declaration from Dr. Bryan Knodel (IS1005) is provided
`
`in support.
`
`Grounds
`Ground 1
`
`Ground 2
`
`Ground 3
`
`Ground 4
`
`Claims
`1-11, 24
`
`1-11, 24
`
`Basis for Rejections under 35 U.S.C. § 103
`Obvious over Giordano (IS1014) in view of
`Wallace (IS1008)
`Obvious over Giordano (IS1014) in view of
`Wallace (IS1008) and Tierney (IS1009)
`Obvious over Shelton (IS1015) in view of Wallace
`(IS1008) and Tierney (IS1009)
`7, 8, 11, 24 Obvious over Shelton (IS1015) in view of
`Giordano (IS1014) and further in view of Wallace
`(IS1008) and Tierney (IS1009)
`
`1-6, 9-10
`
`7
`
`
`
`Ground 5
`
`5, 6
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`Obvious over Shelton (IS1015) in view of Wallace
`(IS1008) and Tierney (IS1009), and further in view
`of Hueil (IS1016)
`
`Giordano, Shelton, Wallace, Tierney, and Hueil each qualify as prior art
`
`under at least 35 U.S.C. § 102(b) because they are all patents that issued, or patent
`
`applications that published, more than one year before May 27, 2011, the priority
`
`application that first added subject matter related to robotic embodiments.
`
`Giordano is the publication of the first priority application of the ’969
`
`Patent, and discloses the structure of prior art handheld surgical instruments.
`
`Wallace, Tierney, Shelton, and the patent that issued from Hueil were each made
`
`of record during prosecution as part of an 82-page IDS that listed over 2,000
`
`references. IS1002, 357-438. Only Tierney, however, was substantively discussed
`
`during prosecution. Id. at 280-285. Additionally, the combinations presented here
`
`were not considered by the examiner.
`
`V.
`
`SUMMARY OF THE ’969 PATENT
`Although the ’969 Patent contains subject matter related to both handheld
`
`surgical instruments and instruments for use with a robotic surgical system, the
`
`claims all relate to the robotic embodiments, as the title of the patent makes clear:
`
`“DRIVE INTERFACE FOR OPERABLY COUPLING A MANIPULATABLE
`
`SURGICAL TOOL TO A ROBOT.” IS1001, Title; see also 11:12-42; 23:50-
`
`24:39. The disclosed robotic surgical system includes the typical and expected
`
`8
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`
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`components, such as a “master controller and robotic arm cart” and a “tool drive
`
`assembly” that control surgical instruments. IS1001, 23:50-62; 24:62-25:29; FIGs.
`
`26-27. As explained above, the robotic surgical system disclosed in the ’969
`
`patent was copied from Petitioner’s prior art.
`
`Various embodiments of the claimed surgical tool include features from the
`
`prior art, for example, (1) a tool mounting portion; (2) an end effector (such as a
`
`surgical stapler); (3) a shaft assembly for coupling the end effector to the tool
`
`mounting portion; (4) an articulation joint; (5) a closure tube assembly; and/or (6) a
`
`“tube gear segment 5114” on the shaft of the instrument, which is used to rotate the
`
`shaft and end effector relative to the tool mounting portion:
`
`Tool mounting portion
`
`Articulation joint
`
`Closure tube
`
`Shaft assembly
`
`End Effector
`
`
`
`9
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`
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`
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`
`End Effector
`
`IS1001, FIGs. 26, 102; 25:1-26:56; 27:19-47; 30:26-64; 65:32-64; 82:42-83:23.
`
`
`
`
`
`None of these features were novel as of the filing of the ’969 Patent or its
`
`parent application (filed on May 11, 2011) to which the ’969 Patent claims priority.
`
`VI. PROSECUTION HISTORY
`During prosecution, the USPTO issued a single office action rejecting the
`
`broad independent claims, but indicating that two independent picture claims and a
`
`variety of dependent claims contained allowable subject matter. IS1002, 280-284.
`
`The broad claims were rejected over Petitioner’s Tierney reference. Id.; IS1009
`
`(Tierney). The applicant subsequently amended the independent claims to include
`
`10
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`
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`subject matter deemed allowable and added new dependent claims containing the
`
`allowable subject matter of original dependent claims. IS1002, 311, 304-310. The
`
`examiner then issued a notice of allowance. Rather than allow the patent to issue,
`
`applicant filed an RCE and submitted an IDS listing over 2,000 references.
`
`IS1002, 328-333; 357-483. A notice of allowance promptly followed, and the ’969
`
`Patent issued on July 9, 2013. IS1002, 547-552; IS1001, Face.
`
`VII. PRIORITY DATE
`The ’969 Patent is directed to robotic embodiments. The robotic
`
`embodiments were added in the CIP application filed on May 27, 2011 (U.S.
`
`Application No. 13/118,259). The prior application, U.S. Application No.
`
`11/651,807 does not provide support for any of the challenged claims. IS1014.
`
`For example, each of the challenged independent claims (1 and 24) recites a “tool
`
`mounting portion” “being configured to operably interface with the tool drive
`
`assembly” on a “robotic system” with at least one “rotatable body portion.” The
`
`parent ’807 application provides no support for these recitations. IS1005, ¶¶30-31.
`
`Rather, the parent ’807 application is directed toward handheld “endoscopic
`
`surgical instrument[s]” with only a passing reference to “robotic-assisted surgery.”
`
`IS1014, ¶¶15, 89, FIGs. 1-2.
`
`11
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`VIII. CLAIM CONSTRUCTION UNDER 37 C.F.R. §§ 42.104(B)(3)
`For the purposes of IPR only, Petitioner submits that the terms of the ’969
`
`Patent are to be given their broadest reasonable interpretation as understood by one
`
`of ordinary skill in the art at the time in view of the specification (“BRI”).3 37
`
`CFR §§ 42.100(b).
`
`IX. SUMMARY OF THE PRIOR ART
`A. Giordano
`Giordano is the published grandparent application to which the ’969 CIP
`
`patent claims priority. IS1014. Thus, it discloses the same hand-held, two stroke
`
`cutting and fastening instrument 10 disclosed in the ’969 Patent. Compare IS1014
`
`with IS1001. As shown below in Fig. 2 of Giordano, instrument 10 includes an
`
`articulation joint and an articulation control mechanism. IS1014, Fig. 2.
`
`
`3 Petitioner acknowledges that the Office has proposed to change from the BRI
`
`standard to the standard applied in District Courts. See 83 Fed. Reg. 21221
`
`(proposed May 9, 2018). Petitioner submits that the prior art discussed herein
`
`invalidates the challenged claims under either standard. If the Office changes the
`
`rule after the filing of the Petition and applies the new standard to this proceeding,
`
`then due process requires the Office afford Petitioner an opportunity to provide
`
`additional argument and evidence on that issue.
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`12
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`Articulation control mechanism
`
`Articulation joint
`
`
`Instrument 10 also includes a gear driven rotary firing mechanism, a closure
`
`tube assembly, and an elongated shaft assembly that rotates and articulates the end
`
`effector. E.g., IS1014, Figs. 2, 7. The rotary drive transmission of the rotary firing
`
`mechanism is shown below in Fig. 7:
`
`Rotary drive
`transmission
`
`
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`13
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`IS1014, Fig. 7. The end effector and the elongated shaft assembly, which includes
`
`the closure tube assembly and the drive shafts of the rotary firing mechanism, is
`
`shown below:
`
`Drive shafts
`
`End effector
`
`Closure tube
`
`
`
`IS1014, Fig. 5.
`
`B.
`Shelton
`Giordano broadly and unequivocally states that it incorporates Shelton by
`
`reference because it “provides more details about such two stroke cutting and
`
`fastening instruments.” IS1014, ¶39. This statement incorporates at least
`
`Shelton’s description of two stroke cutting and fastening instruments into Giordano
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`14
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`as if it were set out expressly rather than through incorporation. See, e.g., Harari
`
`v. Lee, 656 F.3d 1331, 1335 (Fed. Cir. 2011) (holding that “the broad and
`
`unequivocal language” stating that “[t]he disclosures of the two applications are
`
`hereby incorporate[d] by reference” incorporated the entire disclosures of the two
`
`applications);4 Advanced Display Sys., Inc. v. Kent State Univ., 212 F.3d 1272,
`
`1282 (Fed. Cir. 2000) (“Material not explicitly contained in [a] single, prior art
`
`document may still be considered for purposes of anticipation if that material is
`
`incorporated by reference into the document.”); see also IS1005, ¶37 (confirming
`
`that a POSITA would have understood Giordano to incorporate at least Shelton’s
`
`description of two stroke cutting and fastening instruments).
`
`Shelton discloses a hand-held, two stroke cutting and fasting instrument 10
`
`(“the Shelton stapler”) with a gear driven closure mechanism, a closure tube
`
`assembly, and an elongated shaft assembly that rotates the end effector. IS1015,
`
`Fig. 1.
`
`
`4 See also Biscotti Inc. v. Microsoft Corp., No. 2:13-CV-01015-JRG-RSP, 2017
`
`U.S. Dist. LEXIS 144164, at *12 (E.D. Tex. May 11, 2017) (confirming that
`
`Harari, which addressed incorporation by reference in the context of written
`
`description, also applies to anticipation because “[t]he incorporation by reference
`
`doctrine does not vary across different applications of the doctrine.”).
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`15
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`End effector
`
`Elongated shaft assembly
`
`
`
`Gear driven closing
`mechanism
`
`Closure tube
`
`C. Wallace
`Wallace describes a gear driven surgical tool 50 for use with Petitioner’s
`
`robotic system. IS1005, ¶¶41-42; IS1008, Abstract; 7:33-56, Figs. 1, 30. “The
`
`surgical tool 50 includes a rigid shaft 52 having a proximal end 54, a distal end 56
`
`and a longitudinal axis there between. The proximal end 54 is coupled to a tool
`
`16
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`base 62. The tool base 62 includes an interface 64 which mechanically and
`
`electrically couples the tool 50 to a manipulator on the robotic arm cart.” IS1008,
`
`7:34-40. The surgical tool also includes an elongated shaft assembly that rotates
`
`and articulates an end effector. IS1005, ¶42.
`
`Tool base
`
`Fig. 1
`
`
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`17
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`IPR of U.S. Pat. No.: 8,479,969
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`D. Tierney
`Wallace broadly and unequivocally incorporates “the full disclose of”
`
`Tierney by reference. IS1005, ¶¶43-45; IS1008, 1:10-41. This statement
`
`incorporates all of Tierney into Wallace as if it were set out expressly rather than
`
`through incorporation. See, e.g., Harari, 656 F.3d at 1335; Advanced Display Sys,
`
`212 F.3d at 1282; Biscotti, 2017 U.S. Dist. LEXIS 144164, at *12. As explained
`
`above, Tierney discloses the same robotic system that is disclosed in the ’969
`
`Patent. See Sections I, V.
`
`E. Hueil
`Hueil discloses a handheld surgical stapler that is very similar to the Shelton
`
`and Giordano staplers. Like Shelton, Hueil discloses an articulating surgical sta-
`
`pler with a knife bar. Hueil discloses an additional feature where the knife bar and
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`knife are different components. Hueil further explains the benefit of such an ar-
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`rangement, and thus suggests adding that feature to other prior art surgical staplers,
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`such as Shelton.
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`X. THERE IS A REASONABLE LIKELIHOOD THAT AT LEAST ONE
`CLAIM OF THE ’969 PATENT IS UNPATENTABLE
`To arrive at the subject matter claimed in the ’969 Patent, the applicants
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`merely took the obvious step of modifying their prior art hand-held surgical
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`instrument systems to include a tool mounting portion that can be mounted to, and
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`driven by, Petitioner’s robotic surgical system instead of a physician’s hand. See
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`18
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`IS1005, ¶¶28, 46-48; IS1015, FIG. 22; IS1009, Fig. 4; compare IS1001, Fig. 2 with
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`IS1001, Fig. 26; see also In re Venner, 262 F.2d 91, 95 (C.C.P.A. 1958) (holding
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`that broadly providing an automatic means to replace a manual activity which
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`accomplished the same result is not sufficient to distinguish over the prior art). For
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`example, Giordano (which incorporates by reference the prior art surgical stapler
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`of Shelton), when adapted for use with a surgical robot as suggested by Wallace
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`(which incorporates the surgical robotic system of Tierney) results in the robotic
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`surgical stapler disclosed and claimed in the ’969 Patent.
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`19
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`
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`Giordano’s incorporation of Shelton Wallace’s incorporation of Tierney
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`IS1015, FIG. 22
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`IS1009, Fig. 4
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`
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`IS1001, FIG. 26. Thus, claims 1-11 and 24 of the ’969 Patent are invalid. Id.
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`A. Ground 1: Claims 1-11 and 24 Would Have Been Obvious Over
`Giordano in View of Wallace
`As explained below, claims 1-6 and 9-10 would have been obvious over
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`Shelton’s stapler (incorporated into Giordano) as modified to interface with
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`Wallace/Tierney’s robotic system. Claims 7 and 8 would have been obvious over
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`Shelton’s stapler as modified to include Giordano’s drive screw firing mechanism
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`and as further modified to interface with Wallace/Tierney’s robotic system.
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`Claims 11 and 24 would have been obvious over Shelton’s stapler as modified to
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`20
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`
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`include Giordano’s articulation system and as further modified to interface with
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`Wallace/Tierney’s robotic system (which also discloses articulating surgical
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`instruments).
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`[1.P] A surgical tool for use with a robotic system that has a tool drive assembly
`that is operatively coupled to a control unit of the robotic system that is operable
`by inputs from an operator and is configured to provide at least one rotary
`output motion to at least one rotatable body portion supported on the tool drive
`assembly, said surgical tool comprising:
`If the preamble is limiting, Giordano in view of Wallace discloses it.
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`IS1005, ¶¶49-59. For claim 1, this petition relies on the Shelton embodiment
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`incorporated by reference into Giordano.
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`“A surgical tool for use with a robotic system”
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`Giordano’s incorporation of Shelton discloses “surgical stapling and
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`severing instrument 10” (“the Shelton stapler”), which is a manually operated
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`surgical tool. IS1005, ¶¶49-55; IS1015, 5:22-45, Figs. 1-2.
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`It would have been obvious, in view of Wallace, to modify the Shelton
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`stapler for use with a robotic system. IS1005, ¶50. In fact, although legally
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`21
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`
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`unnecessary, the Shelton components merge relatively seamlessly into the Wallace
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`robotic system. See Allied Erecting and Dismantling Co., Inc. v. Genesis
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`Attachments, LLC, 825 F.3d 1373 (Fed. Cir. 2016) (not necessary that references
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`be physically combinable).
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`We first explain the Shelton stapler operation. To use Shelton’s stapler, a
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`surgeon operates a first trigger to open and close the anvil and a second trigger to
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`fire the stapler (drive a knife and wedge sled through the stapler). As shown in
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`FIG. 6, closure trigger 26 causes “gear segment section 76” to rotate which meshes
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`with “gear rack 100” causing gear rack 100 and its attached “yoke 86” to move
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`distally. The yoke is “snap-fitted” to the proximal end of the closure sleeve 32,
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`which moves distally to close the anvil. IS1015, 7:38-67.
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`22
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
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`Drive rod 140
`First gear rack 154
`Second gear rack 142
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`Gear rack 100
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`Gear segment section 76
`(closure gear)
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`Gear segment section
`156 (firing gear)
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`
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`For firing the stapler, a surgeon would pull “firing trigger 28” which rotates “gear
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`segment section 156” which meshes with “second gear rack 142” on “drive
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`member 138”. Drive member 138 meshes with “pinion gear 152” which turns the
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`“multiplier 136” which moves “first gear rack 154” on “metal drive rod 140.”
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`IS1015, 9:1-46. Thus, the closing motion of Shelton is driven by rotation of “gear
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`segment section 76” and the firing motion is driven by rotation of the “gear
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`segment section 156.”
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`
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`Wallace discloses a surgical tool for use with a surgical robotic system (the
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`details of which are disclosed in Tierney, incorporated by reference into Wallace).
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`23
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`The surgical tool has “tool base 62 which includes an interface 64 which
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`mechanically and electrically couples the tool 50 to a manipulator on the robotic
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`arm cart.” IS1008, 7:37-40. The Wallace tool base includes “gears 400” which are
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`powered from the robot arm and which provide clockwise and counterclockwise
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`rotational actuation motions for Wallace’s instrument. IS1008, 13:48-54. In FIG.
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`30 of Wallace, four actuation gears are disclosed (although only two are labeled as
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`gear “400”). Tierney, incorporated by reference, teaches that the gears would be
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`driven by “driven elements 118” on the interface side of the tool base (which are
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`turned by rotatable bodies on the adapter on the robot arm). IS1009, 16:41-52.
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`Wallace, FIG. 30
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`Tierney, FIG. 6
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`Gears 400
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`
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`Driven
`Elements
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`A POSITA would have readily understood that the Shelton device could be
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`modified for robotic use by removing the handle and triggers and connecting the
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`“second gear rack 142” of Shelton to one of the actuation gears 400 on the Wallace
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`tool base and connecting the “gear rack 100” of Shelton to another one of the
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`24
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`
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`actuation gears 400. In the combination, the gear 400 that replaced “gear segment
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`section 76” of Shelton would drive “gear rack 100” to open and close the anvil of
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`the modified stapler. The gear 400 that replaced “gear segment section 156” of
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`Shelton would drive “second gear rack 142” to fire the modified stapler. IS1005,
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`¶50.
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`In the Shelton figure below, many of the components in the red outline
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`would be moved from the Shelton handle to the tool base of Wallace for coupling
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`to the robot arm:
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`
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`25
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
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`
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`A POSITA would have been motivated to modify the Shelton stapler for use
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`with Wallace’s robotic system for several reasons. IS1005, ¶¶50-55. First, a
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`POSITA would have recognized that Wallace contemplates use of its robotic
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`surgical system with surgical “staplers.” Id.; IS1008, 2:18-21. A POSITA
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`therefore would have turned to Giordano for details on how to implement a robotic
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`tool with a surgical stapler end effector to increase the number of uses for
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`Wallace’s system. A POSITA would have been further motivated to adapt the
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`Shelton stapler for robotic use because Shelton’s stapler uses a rotary closure
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`mechanism and a rotary firing mechanism and thus the disclosures of Giordano
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`(including the incorporated Shelton stapler) are readily adaptable to the rotary
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`interface of Wallace. In addition, Giordano discloses a drive screw mechanism to
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`convert rotary motion to linear motion. IS1005, ¶¶50-55
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`Second, as recognized in the ’969 Patent, “over the years, a variety of
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`minimally invasive robotic (or ‘telesurgical’) systems have been developed to
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`increase surgical dexterity as well as to permit a surgeon to operate on a patient in
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`an intuitive manner.” IS1001, 23:6-57. The robotic systems are designed to work
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`with a variety of surgical tools, including surgical staplers, and thus, a POSITA
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`would have been motivated to modify the Shelton stapler for use with Wallace’s
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`26
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`
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`IPR of U.S. Pat. No.: 8,479,969
`Attorney Docket No. 11030-0049IPA
`robotic system to obtain the benefits of the robotic system (e.g., increased dexterity
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`and intuitive controls). Such staplers have linear components, such as a knife and
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`staple sled, and thus use a rotary to linear motion converter such as a linkage, gear
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`rack, or drive screw, as was well known in the art, and as taught by Shelton and
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`Giordano. IS1005, ¶53.
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`Third, a POSITA would have recognized that Giordano contemplates
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`modification of handheld surgical staplers for use with a surgical robot. For
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`example, Giordano’s incorporation of Shelton explicitly states, “the closing and
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`firing motions may be generated by automated means.” IS1015, 9:47-50.
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`Giordano’s incorporation of Shelton further states:
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`Although an illustrative handle portion 20 described
`herein is manually operated by a clinician, it is consistent
`with aspects of the invention for some or all of the
`functions of a handle portion to be powered (e.g.,
`pneumatic, hydraulic, electromechanical, ultrasonic, etc.).
`Furthermore, controls of each of these functions may be
`manually presented on a handle portion or be remotely
`