Intuitive Surgical, Inc. v. Ethicon LLC

Case: 20-1480 Document: 61 Page: 1 Filed: 02/11/2022 NOTE: This disposition is nonprecedential.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. Case: 20-1480 Document: 61 Page: 5 Filed: 02/11/2022 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 Case: 20-1480 Document: 61 Page: 7 Filed: 02/11/2022 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 Case: 20-1480 Document: 61 Page: 9 Filed: 02/11/2022 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). Case: 20-1480 Document: 61 Page: 10 Filed: 02/11/2022 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 Case: 20-1480 Document: 61 Page: 11 Filed: 02/11/2022 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. Case: 20-1480 Document: 61 Page: 12 Filed: 02/11/2022 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