Intuitive Surgical, Inc. v. Ethicon LLC ( 2022 )


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  • Case: 20-1480     Document: 61    Page: 1   Filed: 02/11/2022
    NOTE: This disposition is nonprecedential.
    United States Court of Appeals
    for the Federal Circuit
    ______________________
    INTUITIVE SURGICAL, INC.,
    Appellant
    v.
    ETHICON LLC,
    Appellee
    ANDREW HIRSHFELD, PERFORMING THE
    FUNCTIONS AND DUTIES OF THE UNDER
    SECRETARY OF COMMERCE FOR
    INTELLECTUAL PROPERTY AND DIRECTOR OF
    THE UNITED STATES PATENT AND TRADEMARK
    OFFICE,
    Intervenor
    ______________________
    2020-1480; 2020-1482
    ______________________
    Appeals from the United States Patent and Trademark
    Office, Patent Trial and Appeal Board in Nos. IPR2018-
    01247, IPR2018-01254.
    ______________________
    Decided: February 11, 2022
    ______________________
    STEVEN KATZ, Fish & Richardson P.C., Boston, MA, ar-
    gued for appellant. Also represented by RYAN PATRICK
    Case: 20-1480     Document: 61     Page: 2    Filed: 02/11/2022
    2                    INTUITIVE SURGICAL, INC.   v. ETHICON LLC
    O'CONNOR, JOHN C. PHILLIPS, San Diego, CA.
    ANISH R. DESAI, Weil, Gotshal & Manges LLP, New
    York, NY, argued for appellee. Also represented by
    ELIZABETH WEISWASSER; PRIYATA PATEL, CHRISTOPHER
    PEPE, Washington, DC.
    SARAH E. CRAVEN, Office of the Solicitor, United States
    Patent and Trademark Office, Alexandria, VA, argued for
    intervenor. Also represented by THOMAS W. KRAUSE,
    FARHEENA YASMEEN RASHEED, MOLLY R. SILFEN.
    ______________________
    Before O’MALLEY, CLEVENGER, and STOLL, Circuit Judges.
    O’MALLEY, Circuit Judge.
    Intuitive Surgical, Inc. (“Intuitive”) appeals from two
    final written decisions of the Patent Trial and Appeal
    Board (“Board”) upholding the patentability of claims 24–
    26 of 
    U.S. Patent No. 8,479,969
    .
    At issue in this case is whether the Board erred in up-
    holding the patentability of claim 24 of the ’969 patent over
    the combination of the Giordano and Wallace prior art ref-
    erences, and in upholding the patentability of claims 24–26
    over the combination of the Timm and Anderson prior art
    references. We hold that the Board did not err and affirm.
    I. BACKGROUND
    A.
    In minimally invasive surgery (“MIS”), a surgeon uses
    specialized surgical techniques and tools to access a patient
    through smaller incisions than would typically be used in tra-
    ditional open surgery. MIS benefits patients by reducing
    hospital stays and costs, providing shorter recovery times,
    and improving operating room efficiency.
    Case: 20-1480     Document: 61       Page: 3   Filed: 02/11/2022
    INTUITIVE SURGICAL, INC.   v. ETHICON LLC                   3
    The ’969 patent, entitled “Drive Interface for Operably
    Coupling a Manipulatable Surgical Tool to a Robot,” relates
    to a robotically controlled endoscopic surgical instrument
    commonly used in MIS procedures. As disclosed in the ’969
    patent, a robotically controlled surgical instrument com-
    prises a robotic system with a control unit (e.g., a control-
    ler) and a shaft that includes an electronically conductive
    elongated member. The surgical instrument comprises an
    end effector connected to a distal end of the shaft and re-
    ceives command from the control unit for surgical func-
    tions. A surgeon may remotely control the surgical
    instrument with the controller to robotically perform an
    MIS.
    The end effector may consist of various surgical tools,
    such as a surgical stapler (also known as an endocutter)
    capable of cutting and stapling tissue. The ’969 patent de-
    scribes the endocutter as having a pair of jaws that are con-
    figured to grasp and clamp onto tissue within the body of a
    patient. One jaw typically has a staple cartridge and the
    other jaw (referred to as an anvil) has the ability to clamp
    down on tissue to secure it. Once a patient’s tissue is se-
    cured between the jaws, the movement of a sled causes the
    staples to fire from the cartridge, deforming against the an-
    vil and forming several rows of staples that secure the tis-
    sue. Notably, in claims 24–26, the distal end of the shaft
    comprises an articulation joint to facilitate articulation of
    the end effector. Articulation means that part of the surgi-
    cal tool can move relative to the tool shaft. A sample end
    effector with an articulation joint (14) is shown in Figure 2:
    Case: 20-1480    Document: 61     Page: 4    Filed: 02/11/2022
    4                    INTUITIVE SURGICAL, INC.   v. ETHICON LLC
    The articulation joint allows the shaft to articulate along
    two axes. Articulation cables couple the articulation joint
    to the tool mounting portion, such that the articulation
    joint may be operated by rotary motion from the robotic
    system. The ’969 patent also contains tactile feedback sen-
    sors in the end effector.
    Claim 24 is the primary claim at issue on appeal: 1
    A surgical tool for use with a robotic system that
    has a tool drive assembly that is operatively cou-
    pled to a control unit of the robotic system that is
    operable by inputs from an operator and is config-
    ured 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:
    a surgical end effector comprising at least one com-
    ponent portion that is selectively movable between
    first and second positions relative to at least one
    1   As noted, claims 25 and 26 are also at issue in the
    IPR predicated on the Timm and Anderson references. Be-
    cause those two claims depend from claim 24 and Intuitive
    makes no unique arguments relating to their validity, we
    focus solely on claim 24.
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    INTUITIVE SURGICAL, INC.   v. ETHICON LLC                   5
    other component portion thereof in response to con-
    trol motions applied to said selectively movable
    component portion;
    an elongated shaft assembly defining a longitudinal
    tool axis and comprising:
    a distal spine portion operably coupled to
    said end effector; and
    a proximal spine portion pivotally coupled
    to said distal spine portion at an articula-
    tion joint to facilitate articulation of said
    surgical end effector about an articulation
    axis that is substantially transverse to said
    longitudinal tool axis; and
    at least one gear-driven portion that is in
    operable communication with said at least
    one selectively movable component portion
    of said surgical end effector and wherein
    said surgical tool further comprises:
    a tool mounting portion operably coupled to
    a distal end of said proximal spine portion,
    said tool mounting portion being config-
    ured to operably interface with the tool
    drive assembly when coupled thereto, said
    tool mounting portion comprising:
    a driven element rotatably sup-
    ported on said tool mounting por-
    tion and configured for driving
    engagement with a corresponding
    one of the at least one rotatable
    body portions of the tool drive as-
    sembly to receive corresponding ro-
    tary output motions therefrom; and
    a transmission assembly in opera-
    ble engagement with said driven
    Case: 20-1480     Document: 61     Page: 6    Filed: 02/11/2022
    6                    INTUITIVE SURGICAL, INC.   v. ETHICON LLC
    element and in meshing engage-
    ment with a corresponding one of
    said at least one gear-driven por-
    tions to apply actuation motions
    thereto to cause said corresponding
    one of said at least one gear driven
    portions to apply at least one con-
    trol motion to said selectively mov-
    able component.
    J.A. 338.
    Four prior art references are relevant to this consoli-
    dated appeal: U.S. Patent Application No. 2008/0167672
    (“Giordano”), 
    U.S. Patent No. 6,699,235
     (“Wallace”), 
    U.S. Patent No. 7,510,107
     (“Timm”), and 
    U.S. Patent No. 6,783,524
     (“Anderson”). Giordano claims a handheld sur-
    gical instrument for use in MIS, including the non-robotic
    elements but not the robotic claim limitations of the ’969
    patent. J.A. 1563–1769. Giordano discloses an articula-
    tion pivot, which allows the surgical tool to bend relative to
    the shaft, and an articulation control, which allows a sur-
    geon to control rotational articulation about the pivot. Ad-
    ditionally, Giordano incorporates 
    U.S. Patent No. 6,978,921
     (“Shelton”), which itself discloses a handheld
    surgical instrument that has a stapler end effector, but no
    articulation joint.
    Wallace claims a robotically controlled surgical stapler
    and discloses the same robotic elements as the ’969 patent
    and similar non-robotic elements. J.A. 1311–44. In Wal-
    lace, the distal end of the surgical stapler contains a wrist
    mechanism allowing for articulate movements during MIS.
    Timm describes a handheld surgical stapler. J.A.
    1423–1562. In Timm, the stapler possesses both active and
    passive articulation joints. The passive articulation joints
    may be locked or unlocked. In the locked state, the passive
    articulation joint does not move. In the unlocked state, the
    passive articulation joint moves when pressed against
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    INTUITIVE SURGICAL, INC.   v. ETHICON LLC                   7
    some other object and thus moves the instrument tip. A
    surgeon may thus unlock the passive articulation joint and
    move the joint by pressing the tool against some other ob-
    ject and then lock the joint once it has reached the sur-
    geon’s desired position.
    Anderson describes a robotic surgical tool with an end
    effector that includes an ultrasound probe tip for cutting
    and cauterizing tissue. J.A. 1132–1237. Anderson also dis-
    closes robotic elements and non-robotic elements that are
    similar to those disclosed in the ’969 patent. The Anderson
    invention provides the surgeon with tactile feedback,
    where sensors located on the end effector sense the forces
    applied to the surgical tool and electronically relay this in-
    formation back to the surgeon’s workstation at the master
    controller. Anderson does not describe passive articula-
    tion.
    B.
    Intuitive filed three petitions with the Board, each con-
    tending claim 24 is invalid as either anticipated or obvious.
    Only the two petitions asserting claim 24 would have been
    obvious—IPR2018-01254 (“the Giordano/Wallace proceed-
    ing”) and IPR2018-01247 (“the Timm/Anderson proceed-
    ing”)—are relevant to these combined appeals.
    In the Giordano/Wallace proceeding, Intuitive argued
    that claims 1–11 and 24 would have been obvious over the
    Giordano and Wallace prior art references. Claims 1–11
    are not at issue in the appeal from that proceeding. Intui-
    tive set forth two alternative grounds for its contention
    that Intuitive’s proposed combination satisfied claim 24’s
    “articulation joint” limitation.
    First, in what the Board termed Intuitive’s “primary
    combination,” Intuitive argued that claim 24 would have
    been obvious because a person of ordinary skill in the art
    would have been motivated to combine Shelton’s stapler
    end effector with Giordano’s articulation mechanism, and
    Case: 20-1480    Document: 61      Page: 8    Filed: 02/11/2022
    8                    INTUITIVE SURGICAL, INC.   v. ETHICON LLC
    then combine the resulting surgical instrument with Wal-
    lace’s robotic system. Intuitive acknowledged that Shelton
    did not include an articulation joint as required by claim
    24, but proposed modifying Shelton’s shaft assembly—con-
    taining the end effector stapler—with Giordano’s articula-
    tion mechanism—containing the articulation pivot point
    and articulation control. According to Intuitive, a person
    of ordinary skill in the art would have been motivated to
    apply a known technique to a known system to yield pre-
    dictable results without significantly altering or hindering
    the functionality of the Shelton stapler. The Board disa-
    greed, finding no motivation to pursue Intuitive’s primary
    combination because the combination would result in a de-
    vice with a manually controlled articulation control located
    on the instrument’s shaft, contravening Wallace’s express
    purpose of a robotic instrument. The Board also noted that
    Intuitive never described how a person of ordinary skill in
    the art would have modified or replaced Giordano’s manual
    articulation control with another component in the tool
    mounting portion of Wallace.
    Second, in what the Board termed Intuitive’s “alterna-
    tive combination,” Intuitive argued that a person of ordi-
    nary skill in the art would have modified Shelton’s stapler
    to include an articulation joint similar to that described in
    Wallace. Under this line of logic, a person of ordinary skill
    in the art would be motivated to improve Giordano’s disclo-
    sure of one axis movement using Wallace’s disclosure of an
    articulation mechanism using gear-driven articulation
    rods to enable multi-axis, 360 degree movement. Here, too,
    the Board disagreed. The Board found that Intuitive
    waived its “one axis” argument because it was made for the
    first time in the reply brief. The Board also noted that In-
    tuitive’s “one axis” argument contradicted the original the-
    ory Intuitive proffered in its petition—that the only
    motivation for combining Shelton’s surgical stapler with
    Wallace’s articulation mechanism was to achieve the bene-
    fit of multi-axis articulation.      The Board dismissed
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    INTUITIVE SURGICAL, INC.   v. ETHICON LLC                   9
    Intuitive’s argument that Shelton and Wallace were com-
    patible, as Intuitive offered no support for the proposition
    that Shelton’s firing bar could articulate and bend around
    multiple axes.
    In the Timm/Anderson proceeding, Intuitive argued
    that claims 19–26 would have been obvious over the Timm
    and Anderson prior art references. Intuitive contended
    that a person of ordinary skill in the art would have com-
    bined the Timm prior art reference—which disclosed the
    claimed articulating surgical stapler—and the Anderson
    prior art reference—which disclosed the claimed robotic
    system—to obtain the claimed invention. According to In-
    tuitive, a person of ordinary skill in the art would have
    been motivated to combine Timm and Anderson because
    Timm’s end effector and Anderson’s robotic system would
    provide a wide range of articulation movements to facili-
    tate surgery. The Board disagreed once more, finding in-
    sufficient motivation to combine because Timm uses a
    passive articulation joint and Anderson’s robotic system
    lacked the level of tactile feedback needed to safely perform
    passive articulation. The Board also rejected Intuitive’s ar-
    gument that a person of ordinary skill in the art would
    have combined tactile feedback with Anderson’s robotic
    system based on a lack of evidence. Even Intuitive’s expert
    admitted that he was unaware of the existence of any sys-
    tem providing tactile feedback for a passively articulated
    tool.
    Intuitive timely appeals to this court. We have juris-
    diction pursuant to 
    28 U.S.C. § 1295
    (a)(4)(A).
    II. DISCUSSION
    We review the Board’s ultimate obviousness determi-
    nations de novo and review its underlying factual findings
    for substantial evidence. PersonalWeb Techs., LLC v. Ap-
    ple, Inc., 
    917 F.3d 1376
    , 1381 (Fed. Cir. 2019).
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    10                   INTUITIVE SURGICAL, INC.   v. ETHICON LLC
    On appeal, Intuitive argues that the Board erred by up-
    holding the patentability of claim 24 over the combination
    of Giordano and Wallace. Intuitive additionally argues
    that substantial evidence does not support the Board’s
    finding that a person of ordinary skill in the art would not
    have been motivated to combine Timm and Anderson. We
    address each issue in turn.
    A.
    Intuitive asserts that the Board erred in upholding
    claim 24’s patentability over the Giordano and Wallace
    prior art references. According to Intuitive, the Board er-
    roneously required the “articulation control” to be specifi-
    cally discussed in its petition because the “articulation
    control” is not a claim limitation. Intuitive argues that,
    contrary to the Board’s finding, Intuitive properly de-
    scribed how combining Giordano and Wallace meets the ar-
    ticulation joint requirement in claim 24. Specifically,
    Intuitive asserts that a person of ordinary skill in the art
    would have removed and replaced Giordano’s handle—
    which hosts Giordano’s articulation control—with Wal-
    lace’s tool mounting portion, which implies that Giordano’s
    articulation control would no longer externally reside on
    the handle of the surgical instrument.
    But Intuitive’s arguments misinterpret the Board’s
    findings. The Board correctly found that Intuitive failed to
    explain how a person of ordinary skill in the art would have
    modified Giordano’s articulation control to be remotely con-
    trolled by Wallace’s robotic system. It found that the pri-
    mary combination did not include any modification to
    relocate Giordano’s articulation control into Wallace’s tool
    mounting portion. Although Intuitive argues in its reply
    brief that Giordano’s manual articulation control would be
    coupled into the tool base of the Wallace robot, that argu-
    ment was not set forth in Intuitive’s initial petition and
    was not raised until after Ethicon pointed out the deficien-
    cies in Intuitive’s petition. More crucially, the Board did
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    INTUITIVE SURGICAL, INC.   v. ETHICON LLC                  11
    not abuse its discretion in excluding Intuitive’s reply argu-
    ment. Petitioners may not use reply briefs to cure deficien-
    cies in their petitions. Wasica Fin. GmbH v. Cont’l Auto.
    Sys., Inc., 
    853 F.3d 1272
    , 1286–87 (Fed. Cir. 2017) (“We
    also are unpersuaded by Continental’s attempts to cure the
    petition’s deficiencies in its subsequent briefing to the
    Board and to us.”). Although Intuitive terms its argument
    a “post-petition clarification,” the Board is well within its
    discretion to disregard this belated argument and rely only
    on Intuitive’s petition and its expert declaration—neither
    of which discussed relocating Giordano’s articulation con-
    trol to Wallace’s tool mounting portion. Intuitive only ad-
    dressed Giordano’s articulation control once in its petition,
    vaguely stating that a person of ordinary skill in the art
    would have been motivated to combine because “it would
    have been obvious, in view of Wallace, to adapt the result-
    ing device . . . for use with a surgical robotic system.” Alt-
    hough Intuitive has since made extensive arguments on
    appeal with respect to locating the articulation control in
    Giordano’s handle on Wallace’s “tool mounting portion,” In-
    tuitive never presented these arguments to the Board, ei-
    ther in its petition or even in its reply.
    Intuitive also argues that the Board erred in focusing
    on non-claim terms, such as “articulation control.” We are
    unconvinced. Intuitive shoulders the burden to present
    compelling evidence showing that a person of ordinary skill
    in the art would have been motivated to combine
    Giordano’s manual articulation control with Wallace’s ro-
    botic system. The Board focused on Giordano’s “articula-
    tion control” not as a claim limitation, but as evidence of
    Intuitive’s failure to adequately explain how a person of or-
    dinary skill in the art would have combined the Giordano
    prior art reference with the Wallace prior art reference to
    satisfy the limitations of claim 24.
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    12                   INTUITIVE SURGICAL, INC.   v. ETHICON LLC
    B.
    Next, substantial evidence supports the Board’s deci-
    sion to uphold claim 24’s patentability over the Timm and
    Anderson prior art references. On appeal, Intuitive argues
    that the Board erred in finding that there was no motiva-
    tion for a person of ordinary skill in the art to combine the
    Timm and Anderson references. Specifically, it asserts
    that the Board’s finding rested on the erroneous assump-
    tion that tactile feedback would be required in every form
    of passive articulation. Intuitive points to testimony by its
    expert witness Dr. Knodel that tactile feedback may not be
    necessary in all surgical procedures. We disagree. The
    Board relied upon the expert testimony of Ethicon’s expert
    witness Dr. Fegelman to make the factual finding that tac-
    tile feedback would be necessary in a surgical instrument
    with a passive articulation joint. The Board also properly
    found Dr. Knodel’s testimony to be undermined by his own
    admission that “passive articulation against a structure in
    the body raises concerns of damaging tissue due to exces-
    sive force.” J.A. 30. To the extent that Intuitive argues
    that tactile feedback is not required for every surgical pro-
    cedure involving passive articulation, that argument is a
    factual dispute. Because the Board’s factual finding on this
    point was supported by substantial evidence, we decline to
    disturb it.
    III. CONCLUSION
    We have considered Intuitive’s remaining arguments
    and find them unpersuasive. For the reasons discussed
    above, on this record, the Board did not err in upholding
    the patentability of claim 24 of the ’969 patent over the
    combinations of Giordano/Wallace and Timm/Anderson.
    Accordingly, we affirm the decision of the Board.
    AFFIRMED
    

Document Info

Docket Number: 20-1480

Filed Date: 2/11/2022

Precedential Status: Non-Precedential

Modified Date: 2/14/2022