Auris Health, Inc. v. Intuitive Surgical Operations

Opinion

Case: 21-1733 Document: 42 Page: 1 Filed: 05/05/2022

NOTE: This disposition is nonprecedential.

United States Court of Appeals for the Federal Circuit ______________________

AURIS HEALTH, INC., Appellant

v.

INTUITIVE SURGICAL OPERATIONS, INC., Appellee ______________________

2021-1733 ______________________

Appeal from the United States Patent and Trademark Office, Patent Trial and Appeal Board in No. IPR2019- 01547. ______________________

Decided: May 5, 2022 ______________________

THOMAS ANTHONY BROUGHAN, III, Sidley Austin LLP, Washington, DC, argued for appellant. Also represented by RYAN C. MORRIS; CHING-LEE FUKUDA, TIMOTHY Q. LI, New York, NY; PAUL J. ROGERSON, Chicago, IL.

ARPITA BHATTACHARYYA, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Palo Alto, CA, argued for appellee. Also represented JACOB ADAM SCHROEDER; FRANK A. DECOSTA, III, Washington, DC. ______________________ Case: 21-1733 Document: 42 Page: 2 Filed: 05/05/2022

Before DYK, PROST, and REYNA, Circuit Judges. DYK, Circuit Judge. Auris Health, Inc. (“Auris”) appeals a decision of the Patent Trial and Appeal Board (“Board”) holding that in- dependent claims 16, 51, and 53 and dependent claims 22– 23 and 25–26 of Intuitive Surgical Operations, Inc.’s (“In- tuitive”) U.S. Patent No. 6,522,906 (“the ’906 patent”) were not unpatentable as obvious. We affirm the Board’s hold- ing with respect to claims 51 and 53 because the Board did not err in concluding that Auris failed to prove that a skilled artisan would have had a reasonable expectation of success in modifying the prior art to disengage and reen- gage the master controls. The Board did not reach the rea- sonable expectation of success issue with respect to claim 16 and the corresponding dependent claims. It held in- stead that Auris’s asserted prior art references did not dis- close the disassociating limitation. We conclude that the Board’s finding that the combination did not disclose the disassociating limitation was based on an improper claim construction, and we vacate and remand the Board’s deci- sion for further proceedings with respect to claims 16, 22– 23, and 25–26. BACKGROUND Intuitive’s ’906 patent is directed to systems and meth- ods for performing robotically-assisted surgery using a master control. See ’906 patent, col. 3, ll. 25–39. The pa- tent contemplates dual functionality using a master control and two modes of operation—one in which the master con- trol directs a surgical robot, and one in which the master control can be used to add and view auxiliary information on or alongside a live image of the surgical field. Id., col. 3, l. 41–col. 4, l., 23. It also contemplates switching between these two modes of operation. Case: 21-1733 Document: 42 Page: 3 Filed: 05/05/2022

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These concepts are reflected in the bodies of the inde- pendent claims. Claim 16 recites: 16. A method of performing a surgical procedure on a patient, the method comprising: manipulating a linkage of a master control in three dimensions whilst viewing a real time image of a surgical site on an image display; moving an end effector in response to the manipula- tion of the linkage of the master control, said end effector visible on said image display, so as to per- form at least part of a surgical procedure at the sur- gical site; selectively accessing a source of auxiliary infor- mation in response to the manipulation of the link- age of the master control; and displaying the auxiliary information on the image display, wherein the master control is operatively associ- ated with the end effector to cause the end effector to move in response to the manipulating of the master control, and wherein the selectively access- ing the source of auxiliary information comprises disassociating the master control from the end effec- tor. Id., col. 30, ll. 17–35 (emphasis added). Claim 51 recites: 51. A method for preparing for or performing a ro- botic surgical procedure at a surgical site on a pa- tient, the method comprising: displaying information relevant to the surgical pro- cedure on an image display of the robotic surgical system; Case: 21-1733 Document: 42 Page: 4 Filed: 05/05/2022

manipulating a linkage of a master control of the robotic surgical system in three dimensions while viewing the image display; moving an end effector of the robotic surgical system in response to the manipulation of the linkage of the master control so as to prepare for or perform at least part of a surgical procedure at the surgical site when the robotic surgical system is in a first operating mode; and changing the displayed information on the image display of the robotic surgical system in response to the manipulation of the linkage of the master control when the robotic surgical system is in a sec- ond operating mode. Id., col. 32, l. 65–col. 33, l. 15 (emphasis added). Claim 53 recites: 53. A system for performing a surgical procedure at a surgical site on a patient, the system comprising: a master having an input device, a linkage of the input device configured for manipulation by a hand of a system operator so as to define a manipulation in three dimensions; a surgical end effector; an image display for displaying information rele- vant to the surgical procedure; and a processor coupling the input device to the end ef- fector and the image display, the processor having first and second operating modes, the processor in the first operating mode effecting movement of the end effector in response to the manipulation of the input device, the processor in the second operating mode changing the displayed information in re- sponse to the manipulation of the input device. Case: 21-1733 Document: 42 Page: 5 Filed: 05/05/2022

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Id., col. 34, ll. 3–19. The parties appear to agree that these claims require hand-held controls be used to both access the auxiliary information and manipulate the robotic sur- gical device. Auris petitioned for inter partes review of claims 16, 22–23, 25–26, 51, and 53. It asserted six combinations of four prior art references—Borst, Salvati, Wang ’099, and Wang ’850—to support its unpatentability contentions. Borst was the primary prior art reference for each of the asserted grounds. The preferred embodiment of the robotic surgical system disclosed in Borst has “at least one control robotic instrument to be manually operated and connected to the robotic computer system to supply the robotic com- puter system with control signals.” PCT International Ap- plication Publication No. WO 95/01757 (“Borst”), col. 11, ll. 15–17. The robotic computer system controls “at least one robotic surgical instrument” that is “connected to the robot arm.” Id. at col. 11, ll. 9–11. Borst describes utilizing cam- eras to produce “arrested video image[s]” of a moving sur- gical target area, such as a beating heart, id. at col. 22, ll. 25–33, and the system’s robotic surgical arms “track the [moving surgical] target in real time,” id. at col. 23, ll. 6–8. Using “voice control” or “other means. . . e.g. [] a foot switch,” the surgeon can zoom in and out of the arrested video images. Id. at col. 18, l. 25–col. 19, l. 1. Salvati teaches a dual-mode endoscope that has a “steering control mechanism and a viewing screen conven- iently combined in a hand-held control unit.” U.S. Patent No. 5,373,317 (“Salvati”), col. 2, ll. 25–27. In the “first mode,” the joystick controls the “bending of the endoscope or borescope articulation neck; and in a second mode,” it controls “the cursor position of the viewing screen.” Id. at col. 2, ll. 30–33. Wang ’099 teaches a master controller that includes a “means for receiving selection commands and . . . control Case: 21-1733 Document: 42 Page: 6 Filed: 05/05/2022

commands . . . included in a voice control interface (“VCI”).” 1 U.S. Patent No. 6,496,099 (“Wang ’099”), col. 2, ll. 32–35. Selection or control commands may also be re- ceived through “a foot pedal, a hand held device, or some other device.” Id. at col. 2, ll. 36–37. The master controller is connected to slave controllers—one of which controls a surgical robot, while the other controls a network gateway used to access patient information available at a hospital computer terminal, which “includes, but is not limited to x- rays, patient history, MRIs, angiography and CAT scans.” Id. at col. 10, ll. 31–39. With the master controller, a sur- geon can “select[] and control[] a plurality of devices . . . in electrical communication or in wireless communication with the master controller, either directly or via a slave controller.” Id. at col. 2, ll. 14–18. Before the Board, Auris contended that Borst taught every element of the independent claims except for a mas- ter control with dual operating modes. For that element, Auris proposed that Borst could be modified to incorporate the identified dual-mode functionality disclosed in either Salvati or Wang ’099. At oral argument, Auris explained that the proposed combination would be “using Borst’s hand controls for both purposes”—that is, using the hand controls to manipulate a robotic surgical device and to ac- cess the auxiliary information. Oral Arg. 2:10–2:44. Auris proposed that a skilled artisan would have been motivated to combine Borst with Salvati or Wang ’099 be- cause Borst taught that its “zooming [action] may be pro- vided by other means than by voice activation.” Borst, col. 18, l. 36–col. 19, l. 1. Auris’s expert witness, Dr. Hanna- ford, testified that a master control could perform the

1 Selection commands select a device for use, such as a laser. Control commands and signals are then routed to that device once it has been selected. Case: 21-1733 Document: 42 Page: 7 Filed: 05/05/2022

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zooming function, and that a skilled artisan would have been motivated to combine that function into the master control to simplify Borst’s separate controls and avoid the need for a second input device. J.A. 1014, ¶¶ 92-93 (“A POSA would have been motivated to modify Borst to achieve the same benefit by removing the separate joy- stick/mouse and allowing the control instruments to per- form the functions of the joystick/mouse.”). With respect to claims 51 and 53, the Board held that Auris failed to demonstrate that a skilled artisan would have reasonably expected to successfully modify Borst’s system to incorporate either Salvati or Wang ’099’s dual modes. It relied on Intuitive’s unrebutted expert testimony that both combinations would require “at least five signifi- cant reconfigurations in the robotic system” to incorporate the dual-mode functionality. J.A. 35; see also J.A. 51. For claim 16 and the corresponding dependent claims, the Board held that the combination of Borst and Wang ’099 did not disclose the disassociation limitation, finding that Wang did not teach “operatively disassociat[ing] from the other devices” when the user switched between using the surgical robot and accessing the patient data. J.A. 43. 2 Auris appeals. We have jurisdiction under 28 U.S.C. § 1295(a)(4). DISCUSSION We review “the Board’s conclusions of law de novo” and its “findings of fact for substantial evidence.” Homeland Housewares, LLC v. Whirlpool Corp., 865 F.3d 1372, 1374 (Fed. Cir. 2017). “Obviousness is a question of law” that is “based on multiple underlying factual determinations,

2 Unlike claims 51 and 53, Auris did not challenge claim 16 and its corresponding dependent claims on the ba- sis of Borst and Salvati. Case: 21-1733 Document: 42 Page: 8 Filed: 05/05/2022

including whether a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and whether there would have been a reasonable expectation of success in doing so.” TQ Delta, LLC v. Cisco Sys., Inc., 942 F.3d 1352, 1357 (Fed. Cir. 2019) (internal quotation omitted). Claim construction is a legal question reviewed de novo “where, as here, there is no relevant extrinsic evidence.” Homeland Housewares, 865 F.3d at 1374. I. Claims 51 and 53 Auris first argues that the Board’s obviousness analy- sis erroneously extended claim 16’s disassociating limita- tion to claims 51 and 53. Claim 16 teaches a method wherein “selectively accessing a source of auxiliary infor- mation in response to the manipulation of the linkage of the master control . . . comprises disassociating the master control from the end effector.” ’906 patent, col. 30, ll. 26– 28, 34–35 (emphasis added). Unlike claim 16, claims 51 and 53 do not contain an express disassociating limitation. But they do require first and second operating modes re- spectively enabling the surgeon to (1) control the robotic surgical system “in response to the manipulation of the linkage of the master control,” or “the input device,” 3 id. at col. 33, ll. 6–8; col. 34, l. 16, and (2) change the displayed auxiliary information “in response to the manipulation of the linkage of the master control” or “the input device,” id. at col. 33, ll. 13–14; col. 34, ll. 18–19. The Board’s decision did not improperly import claim 16’s disassociating limitation to claims 51 and 53. To the contrary—the Board recognized that “claim[s] 53 [and 51]

3 The input device is connected to the master, as de- scribed in the claims: “a master having an input device, a linkage of the input device configured for manipulation by a hand of a system operator.” ’906 patent, col. 34, ll. 5–7. Case: 21-1733 Document: 42 Page: 9 Filed: 05/05/2022

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do[] not recite disassociating the master control from the surgical instrument.” J.A. 35. But in addressing whether a skilled artisan would reasonably expect success in com- bining Auris’s asserted prior art references, the Board found, based on Intuitive’s expert testimony, that disasso- ciating the master control from the surgical instrument was required to combine Borst’s surgical system with ei- ther Salvati or Wang ’099’s second operating mode. Auris argues that even if the Board were correct in re- quiring disassociating, it erred in concluding that a “skilled artisan would not have reasonably expected success in modifying Borst’s master control to have a second mode.” J.A. 34–35. According to Auris, “a skilled person would have used common sense to engage or disengage Borst’s ‘control robotic instruments’ from the surgical end effec- tors” given that “this functionality was well known” at the time “and described in many prior art references.” Appel- lant’s Opening Br. 47–48, 52. But the Board found that Auris never refuted “persua- sive expert testimony,” J.A. 36, from Intuitive’s expert, Dr. Rentschler, who explained that five different steps would be necessary to successfully modify Borst: 1) [T]oggle to a second mode to place additional in- formation on the display screen, on or alongside the live image of the surgical site, 2) disassociate the master controls from the surgical instruments/end effectors, 3) maintain the current position of the surgical instruments/end effectors, 4) toggle back to the first mode after manipulation of additional information, and 5) reposition master controls in a configuration so as to be engaged with the original end effector locations. J.A. 1898, Ex. 2003 ¶ 81. Regarding the final step, Dr. Rentschler explained that “if Borst’s master control [] [is] used to add information on the screen in a second mode, Case: 21-1733 Document: 42 Page: 10 Filed: 05/05/2022

the position and orientation of the master control itself will change” to a position that differed from the position it was in when the surgeon exited the first mode. J.A. 1897, Ex. 2003 ¶ 80. He further noted that Auris’s proposed combi- nation did not describe “how [the] master control [could] be returned to the position it occupied immediately before transitioning to the second mode, so that engagement be- tween the master control and the end effector [could] be re- established to permit the surgeon to proceed with the sur- gery.” Id. It may be, as Auris argues, that a skilled artisan would know how to overcome these problems. But as Intuitive notes, “Auris offered no evidence rebutting [Dr. Rentsch- ler’s] testimony.” Appellee’s Br. 26. Under these circum- stances, the Board did not err in finding that Auris had “not demonstrated by a preponderance of the evidence that there would have been a reasonable expectation of success in modifying Borst’s system to incorporate a dual function- ing master,” J.A. 36; see also J.A. 51–52, and in concluding that claims 51 and 53 were not shown to be unpatentable. 4 II. Claim 16 and the Dependent Claims The Board’s decision upholding claim 16 and the corre- sponding dependent claims was limited to a finding that Wang ’099 was “missing the element of disassociating the master control from the end effector.” J.A. 43. The Board explained that in Wang ’099, “selecting a ‘device for opera- tion does not mean that [the] master controller [] is

4 In light of our conclusion that substantial evidence supports the Board’s reasonable expectation of success findings for claims 51 and 53, we need not address Auris’s other unpatentability arguments for these claims because they similarly rely on modifying Borst. Auris raises noth- ing concerning the addition of Wang ’850 that would sug- gest the Board erred. Case: 21-1733 Document: 42 Page: 11 Filed: 05/05/2022

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operatively disassociated from the other devices.’” Id. Ac- cording to the Board, Wang ’099 did not disclose “the com- munication” between the master controller and the previously-selected device ever being “even temporarily in- terrupted,” a characteristic the Board believed was re- quired to satisfy the disassociating limitation. Id. The Board also concluded that Auris’s addition of Wang ’850 to the prior art combination failed because Auris did not “per- suasively identify how Wang ’850’s master . . . could be in- tegrated . . . to arrive at the limitation of disassociating a master controller.” J.A. 44. On appeal, Auris contends that the prior art taught the disassociating limitation and that the Board’s conclusion was based on an improper claim construction. Auris ar- gues that the Board’s construction “exclud[ed] any system that maintains any communication between the master control and the end effectors, even if that communication is solely to allow the master controller to later re-establish an operative association.” Appellant’s Opening Br. 53. While the Board’s construction is not entirely clear, we think that Auris is correct in its interpretation of the Board’s decision in that respect, and that the Board’s claim interpretation is too narrow. In describing the disassociating limitation, the ’906 pa- tent specification does not require the wholesale termina- tion of communications between the master control and the controlled devices. The specification explains that “the masters [] are normally operatively associated with the slaves,” but “when one, or both, or either, of the masters are to be used selectively to place an image corresponding to auxiliary information . . . in the image or scene of the surgical site, the operative association between the master, or masters, and the slaves is temporarily interrupted.” ’906 patent, col. 23, ll. 1–7. During this temporary inter- ruption, the “slaves are typically held or locked in station- ary positions at the surgical site . . . in the positions they Case: 21-1733 Document: 42 Page: 12 Filed: 05/05/2022

occupied immediately before disassociation.” Id. at col. 23, ll. 8–11. Thus, disassociating requires only that the oper- ative association be temporarily interrupted in a way that causes the slave devices to be held or locked in stationary position. The Board’s construction erred in requiring an interruption in communication. Auris argues that we should reverse on this issue, ra- ther than remand, because Wang ’099 discloses disassoci- ating under the proper construction. According to Auris, Wang ’099’s “master control is able to electronically control end effectors and separately access patient data from a net- work without causing the end effectors to move.” Appel- lant’s Opening Br. 53. Auris’s expert, Dr. Hannaford, testified that a person of skill in the art would understand that in Wang ’099, “user selection rout[es] control signals to a specified device, and thus, it disassociates the master control from other de- vices.” J.A. 1044, Ex. 1003 ¶ 146 (internal quotation marks omitted). But Intuitive’s expert, Dr. Rentschler, testified to the contrary. See J.A. 1907, Ex. 2003 ¶ 103 (“[T]he Wang ’099 system allows for multiple operating room devices to be active at once.”). We believe the question whether the combination satisfies the disassociating limitation is best left for the Board to address in the first instance. Finally, Intuitive proposes an “alternative reason” to affirm the Board’s decision to uphold claim 16 and the de- pendent claims: that “Auris failed to carry its burden to es- tablish a skilled artisan would have been motivated to modify Borst to include ‘a second operating mode’” with a reasonable expectation of success. Appellee’s Br. 30–31. Intuitive argues that affirming would be proper “given that the Board already made the requisite factual findings on identical facts with respect to” claims 51 and 53. Id. at 31. Contrary to Intuitive’s assertion, the record for claim 16 was not “identical” to the record that the Board relied Case: 21-1733 Document: 42 Page: 13 Filed: 05/05/2022

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on in upholding claims 51 and 53. For example, Intuitive’s experts never testified that the same five steps required to modify Borst—applicable to claims 51 and 53—would be necessary to modify Borst with respect to claim 16. Dr. Rentschler testified only that Auris “has not provided any explanation on how a person skilled in the art would have expected to use Borst’s master control [] to add auxiliary information without inadvertently translating the move- ments of the master control to the end effector within the patient.” J.A. 1909, Ex. 2003 ¶ 106. Intuitive’s other ex- pert, Dr. Grossi, testified only that Borst does not “teach how to disengage/re-engage the master controls with the surgical instruments when transitioning between the two modes of operation.” J.A. 1956, Ex. 2004 ¶ 24. Intuitive’s Patent Owner Response also never refer- enced the five steps argument. It contended only that Au- ris “has [] not established that a person skilled in the art would have had a reasonable expectation of success in mod- ifying Borst’s master controls [] to incorporate the ability to obtain and display auxiliary information,” and charac- terized Auris’s conclusory statements that Borst’s system “could be modified . . . with a high degree of predictability [] that [] would work as expected” as being “insufficient to establish . . . a reasonable expectation of success.” J.A. 386 (internal quotations omitted). Given that Intuitive did not make the same arguments or create the same record for claim 16 as it did for claims 51 and 53, we decline Intuitive’s request to affirm on these alternative grounds. On remand, the Board should con- sider (1) whether Wang ’099 discloses disassociating under the proper construction; and if it does (2) whether claim 16 and the corresponding dependent claims would be nonob- vious, including whether a person of skill in the art would reasonably expect success in combining the asserted prior art references. Case: 21-1733 Document: 42 Page: 14 Filed: 05/05/2022

CONCLUSION For the foregoing reasons, we affirm the Board’s deci- sion with respect to independent claims 51 and 53. We va- cate and remand the Board’s decision with respect to claims 16, 22–23, and 25–26. AFFIRMED IN PART, VACATED AND REMANDED IN PART COSTS No costs.