`
`
`
`NOTE: This disposition is nonprecedential.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
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`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.
`
`
`
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`
`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:
`
`
`
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`INTUITIVE SURGICAL, INC. v. ETHICON LLC
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`4
`
`
`
`
`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
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`5
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`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
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`6
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`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
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`7
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`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
`
`
`
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`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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`INTUITIVE SURGICAL, INC. v. ETHICON LLC
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`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
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`11
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`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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`INTUITIVE SURGICAL, INC. v. ETHICON LLC
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`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
`
`