P TECH, LLCDownload PDFPatent Trials and Appeals BoardSep 3, 2021IPR2020-00649 (P.T.A.B. Sep. 3, 2021) Copy Citation Trials@uspto.gov Paper 31 571-272-7822 September 3, 2021 UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD INTUITIVE SURGICAL, INC., Petitioner, v. P TECH, LLC, Patent Owner. IPR2020-00649 Patent 9,192,395 B2 Before SHERIDAN K. SNEDDEN, MICHELLE N. WORMMEESTER, and CYNTHIA M. HARDMAN, Administrative Patent Judges. HARDMAN, Administrative Patent Judge. JUDGMENT Final Written Decision Determining All Challenged Claims Unpatentable 35 U.S.C. § 318(a) Denying Patent Owner’s Motion to Exclude 37 C.F.R. § 42.64 IPR2020-00649 Patent 9,192,395 B2 1 I. INTRODUCTION This is a Final Written Decision in an inter partes review challenging the patentability of claims 1 and 4 of U.S. Patent No. 9,192,395 B2 (“the ’395 patent,” Ex. 1001). We have jurisdiction under 35 U.S.C. § 6. Petitioner Intuitive Surgical, Inc. has the burden of proving unpatentability of the challenged claims by a preponderance of the evidence. 35 U.S.C. § 316(e). Having reviewed the parties’ arguments and supporting evidence, for the reasons discussed below, we find that Petitioner has demonstrated by a preponderance of the evidence that claims 1 and 4 are unpatentable. We also deny Patent Owner P Tech, LLC’s motion to exclude evidence. A. Real Parties in Interest Petitioner and Patent Owner each identify themselves as the sole real parties in interest. Paper 2 (“Pet.”) 1; Paper 4, 2. B. Related Matters The ’395 patent is involved in P Tech LLC v. Intuitive Surgical, Inc., 1:19-cv-00525-RGA (D. Del.). Pet. 1–2; Paper 4, 2. Petitioner indicates that related U.S. Patent No. 10,368,953 (the “’953 patent”) is also involved in this litigation. Pet. 2. Petitioner filed a petition for inter partes review of related U.S. Patent No. 9,149,281. Pet. 2; Paper 4, 2; see also IPR2020-00650. We note that Petitioner has also filed IPR2020-01687 against the ’953 patent. Petitioner asserts that Patent Owner is prosecuting U.S. Patent Application Nos. 16/272,650, 16/412,008, and 16/674,970, each of which claims the benefit of U.S. App. No. 13/888,957 (i.e., the application that led to the ’395 patent). Pet. 2. IPR2020-00649 Patent 9,192,395 B2 2 C. The ’395 Patent The ’395 patent states that “[a]n improved apparatus and method of securing body tissue may be performed with a robotic mechanism.” Ex. 1001, Abstract. The body tissue may be secured with a fastener such as a suture, staple, or screw. Id. at 1:33–34. Figure 1 of the ’395 patent is reproduced below. Figure 1 above shows an “apparatus 30 for use in securing tissue in a patient’s body.”1 Id. at 4:51–52. The figure “is a schematic illustration depicting the manner in which a robotic mechanism and an imaging device are positioned relative to a patient’s body.” Id. at 2:36–39. The apparatus includes operating table 32, robotic mechanism 38 “to position a tissue 1 Throughout this Decision, we omit bolding of reference numbers in quotes from the ’395 patent and prior art patents. IPR2020-00649 Patent 9,192,395 B2 3 securing device, fastener, or other apparatus at a desired location within the patient during performance of a surgical procedure,” and imaging device 40. Id. at 4:66–5:5. The robotic mechanism “is guided by automatic controls which include the computer 44 and robotic arm interface 46,” and “may have manually operable controls which provide for interaction between the surgeon and the robotic mechanism.” Id. at 5:14–23. Figure 22 of the ’395 patent is reproduced below. Figure 22 above is a schematic illustration depicting the manner in which legs of a staple 306, 308 are bent and “end portions of the staple are bonded together by the robotic mechanism” of Figure 1. Id. at 3:51–55. The ’395 patent describes the elements of Figure 22 as follows: IPR2020-00649 Patent 9,192,395 B2 4 When the staple 300 is utilized to secure the body tissue, end portions 302 and 304 of legs 306 of the staple are moved into engagement (FIG. 22) and bonded together. By bonding the end portions 302 and 304 of the legs 306 and 308 of the staple 300 together, the staple is locked into the tissue 64. Any tendency for the resilient legs 306 and 308 to spring back to their original positions . . . is prevented by the interconnected the end portions 302 and 304 of the legs. Id. at 26:56–63. Figure 26 of the ’395 patent is reproduced below. Figure 26 above “is a schematic illustration depicting the manner in which [staple 346 is inserted into body tissue and] is bent and legs of the staple are bonded together by operation of the robotic mechanism of FIG. 1.” Id. at 4:1–4. IPR2020-00649 Patent 9,192,395 B2 5 The ’395 patent describes the elements of Figure 26 as follows: Continued downward movement of the pusher plate 338 causes force transmitting members or lands 356 and 358 connected to the pusher plate 338 to press against the connector or bight portion 346 of the staple 330 . . . . As the pusher plate 338 continues to be advanced or lowered to the position shown in FIG. 26, the lands or force transmitting members 356 and 358 deflect or bend the legs 342 and 344 to the gripping position illustrated in FIG. 26, to dispose a portion of the body tissue 334 between the legs 342 and 344 and the connector or bight portion 346 of the staple 330 (FIG. 26). . . . Once the staple 330 has been bent or deformed to grip the body tissue 334 in the manner illustrated schematically in FIG. 26, the legs 342 and 344 of the staple are bonded together. . . . Once the legs 342 and 344 of the staple have been bonded together, the staple is released or disengaged from the anvils 350 and 352 by an injector spring 362 having legs 364 and 366 (FIG. 23) which are pressed against the staple 330. This force separates the staple from the anvils 350 and 352. Id. at 29:51–30:37. In one embodiment, the robotic mechanism 38 is used to secure body tissue with a threaded fastener 440. Figure 34 of the ’395 patent is reproduced below. IPR2020-00649 Patent 9,192,395 B2 6 Figure 34 above “is a schematic illustration depicting the manner in which the robotic mechanism of FIG. 1 is utilized to position a threaded fastener in body tissue.” Id. at 4:28–30. The ’395 patent discloses position sensor 452 in the context of the embodiment shown in Figure 34. The ’395 patent provides the following description of Figure 34: IPR2020-00649 Patent 9,192,395 B2 7 The robotic mechanism 38 includes a programmable computer 444 (FIG. 34) which is connected with a fastener drive member 446 by a motor 448. . . . A position sensor 452 is connected with fastener drive member 446 and the computer 444. The position sensor 452 has an output which is indicative of the position of the fastener drive member 446. The output from the position sensor 452 indicates the depth or distance to which the threaded fastener is moved into body tissue by operation of the motor 448 to rotate the fastener drive member 446. . . . By utilizing the robotic mechanism 38 to manipulate the fastener 440, the fastener can be accurately positioned relative to body tissue. . . . In addition, the position sensor 452 enables the distance to which the fastener 440 is moved into the body tissue to be accurately controlled. Id. at 36:36–37:4. D. Illustrative Claims Independent claims 1 and 4 illustrate the claimed subject matter and are reproduced below (with the same bracketed numbering used in the Petition added to the limitations of claim 1): IPR2020-00649 Patent 9,192,395 B2 8 1. [1.1] A robotic fastening system comprising: [1.2] a robotic mechanism including an adaptive arm configured to position a staple relative to a body portion of a patient; [1.3] a robotic arm interface configured to operate the adaptive arm of the robotic mechanism; [1.4] a staple having first and second legs; [1.5] a fastening member coupled to the adaptive arm, the fastening member having first and second force transmitting portions and configured to secure the body portion with the staple by applying a force from the first and second force transmitting portions to move the first and second legs of the staple toward each other; [1.6] at least one of a position sensor configured to indicate a distance moved by the staple and a force measurement device configured to indicate a resistance required to move the staple relative to the body portion; and [1.7] a tissue retractor assembly coupled to the robotic mechanism, the tissue retractor assembly including a cannula configured to facilitate insertion of the fastening member through the cannula into a working space inside the patient. 4. A robotic fastening system comprising: a robotic mechanism including an adaptive arm configured to position a staple relative to a body portion of a patient; a robotic arm interface configured to operate the adaptive arm of the robotic mechanism; an endoscope coupled to the adaptive arm; IPR2020-00649 Patent 9,192,395 B2 9 an imaging device configured provide an image, from the endoscope, of the staple relative to the body portion; a staple having first and second legs; a fastening member coupled to the adaptive arm, the fastening member having first and second force transmitting portions and configured to secure the body portion with the staple based on a location of tissue determined with the image provided by the endoscope by applying a force from the first and second force transmitting portions to move the first and second legs of the staple toward each other; and at least one of a position sensor configured to indicate a distance moved by the staple and a force measurement device configured to indicate a resistance required to move the staple relative to the body portion. Ex. 1001, 44:36–56, 44:60–45:15. IPR2020-00649 Patent 9,192,395 B2 10 E. Asserted Challenges to Patentability Petitioner asserts the following challenges to patentability (Pet. 3): Claim(s) Challenged 35 U.S.C. § Reference(s)/Basis 1, 4 103(a)2 Tierney,3 McGarry4 1 103(a) Tierney, McGarry, Bonutti5 1, 4 103(a) Tierney, Hooven6 1, 4 103(a) Tierney, McGarry, Bonutti, Hooven, Whitman7 1, 4 103(a) Tierney, McGarry, Bonutti, Hooven, Whitman, Madhani,8 Cooper9 Petitioner relies on two declarations from Dr. Gregory Fischer. Ex. 1003 (“Fischer Decl.”); Ex. 1025 (“Fisher Supp. Decl.”). Patent Owner 2 The parties use a 2002 priority date for the challenged claims. Pet. 4; Paper 12, 26. The Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011) (“AIA”), included revisions to 35 U.S.C. § 103 that became effective after this date. Therefore, we apply the pre-AIA version of 35 U.S.C. § 103. 3 US 6,331,181 B1, issued December 18, 2001 (Ex. 1004). 4 US 5,289,963, issued March 1, 1994 (Ex. 1005). 5 US 6,277,136 B1, issued August 21, 2001 (Ex. 1006). 6 US 5,518,163, issued May 21, 1996 (Ex. 1007). 7 US 6,793,652 B1, filed November 28, 2000, issued September 21, 2004 (Ex. 1008). 8 US 5,792,135, issued August 11, 1998 (Ex. 1009). 9 WO 98/25666, published June 18, 1998 (Ex. 1010). IPR2020-00649 Patent 9,192,395 B2 11 relies on two declarations from Dr. Cameron Riviere. Ex. 2001 (“Riviere Decl.”); Ex. 2006 (“Riviere Second Decl.”). II. ANALYSIS A. Legal Principles A patent may not be obtained “if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.” 35 U.S.C. § 103(a) (2012). An obviousness analysis involves underlying factual inquiries including (1) the scope and content of the prior art; (2) differences between the claimed invention and the prior art; (3) the level of ordinary skill in the art; and (4) where in evidence, objective indicia of nonobviousness, such as commercial success, long-felt but unsolved needs, and failure of others.10 Graham v. John Deere Co., 383 U.S. 1, 17–18, 35– 36 (1966). An obviousness determination requires finding “a motivation to combine accompanied by a reasonable expectation of achieving what is claimed in the patent-at-issue.” Intelligent Bio-Sys., Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016). B. Level of Ordinary Skill in the Art Factors pertinent to determining the level of ordinary skill in the art include the type of problems encountered in the art and prior art solutions to those problems. See Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696–97 (Fed. Cir. 1983). The prior art itself may reflect an appropriate skill level. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). 10 On this record, neither party has pointed us to any evidence of objective indicia. IPR2020-00649 Patent 9,192,395 B2 12 Patent Owner proposes that a person of ordinary skill in the art: would have had the equivalent of a Bachelor’s degree or higher in mechanical engineering, electrical engineering, biomedical engineering, or a related field directed towards medical electro- mechanical systems and at least 3 years of experience working with robotic surgical instruments. Experience with robotic surgical instruments could take the place of formal training, as relevant skills may be learned on the job or through practical experience. Alternatively, a higher level of education might make up for less experience. Paper 12 (“Resp.”) 26; Riviere Decl. ¶ 18. Petitioner does not dispute this proposal or provide an alternate proposal. Based on our review of the ’395 patent and the types of problems and solutions described in the ’395 patent and cited prior art, we adopt Patent Owner’s proposal. C. Claim Construction In an inter partes review, we construe a patent claim “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. 282(b).” 37 C.F.R. § 42.100(b) (2019); see also Phillips v. AWH Corp., 415 F.3d 1303, 1312–17 (Fed. Cir. 2005) (en banc). Petitioner addresses the construction of three claim terms. First, Petitioner asserts that “at least one of a position sensor . . . and a force measurement device” (which appears in claims 1 and 4) requires at least one of a position sensor and at least one of a force measurement device. Pet. 17. Patent Owner applies Petitioner’s proposed claim construction. Resp. 29. Because this proposed construction is undisputed and consistent with the claim language, we adopt it. Second, Petitioner mentions but does not provide a proposed construction for the claim term “tissue retractor assembly” (which appears IPR2020-00649 Patent 9,192,395 B2 13 in claim 1). Pet. 18. Patent Owner also does not provide a proposed construction of this claim term, arguing that the term does not require construction. Resp. 29–30. Only claim terms in controversy need be construed. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999). On this record, the parties have not proposed constructions for this claim term, and we see no dispute that requires us to expressly construe this term. Third, Petitioner argues that the claim term “first and second force transmitting portions” (which appears in claim 1 (at limitation [1.5]) and claim 4) should be construed as a means-plus-function limitation under 35 U.S.C. § 112, ¶ 6 (pre-AIA). Pet. 14–16; Paper 15 (“Reply”) 1–2. Petitioner identifies the function performed by the “first and second force transmitting portions” as moving the first and second legs of the staple toward each other, and the corresponding structure disclosed in the Specification as including force transmitting members or lands 356 and 358. Pet. 14–15 (citing Ex. 1001, 29:51–60; Fischer Decl. ¶¶ 47–50). Patent Owner disputes that this term is in means-plus-function format. Resp. 26– 29; Paper 22 (“Sur-reply”) 2. We note that in its arguments relating to the Hooven-based grounds, however, Petitioner does not treat this term as a means-plus-function limitation (see Pet. 16, 64–65), and Patent Owner does not dispute that Hooven discloses “first and second force transmitting portions.” See generally Resp. 57–76. Accordingly, on this record, we need not construe this term to resolve the parties’ disputes under the Hooven-based grounds. Vivid Techs., Inc., 200 F.3d at 803 (“[O]nly those terms need be construed IPR2020-00649 Patent 9,192,395 B2 14 that are in controversy, and only to the extent necessary to resolve the controversy.”). However, even if construction of “first and second force transmitting portions” were necessary to resolve the parties’ disputes under the Hooven- based grounds, we agree with Patent Owner that this claim term is not in means-plus-function format. 35 U.S.C. § 112, ¶ 6 (pre-AIA) states: “An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.” “[F]ailure to use the word ‘means’” in the disputed limitation “creates a rebuttable presumption . . . that § 112, para. 6 does not apply.” Williamson v. Citrix Online, LLC, 792 F.3d 1339, 1348 (Fed. Cir. 2015) (en banc in relevant part). The challenger can overcome the presumption by “demonstrat[ing] that the claim term fails to ‘recite sufficiently definite structure’ or else recites ‘function without reciting sufficient structure for performing that function.’” Id. at 1349 (quoting Watts v. XL Sys., Inc., 232 F.3d 877, 880 (Fed. Cir. 2000)). Although the limitation “first and second force transmitting portions” does not use the word “means,” Petitioner contends under an alternative theory that § 112, para. 6 applies because “portion” is a “nonce word” and the “prefix ‘force transmitting’ does not impart any structure.” Pet. 14. Patent Owner responds that “portion” is not a nonce word, and that persons of ordinary skill in the art would understand “portion” to mean structure. Resp. 28–29 (citing, e.g., various portions of Hooven (Ex. 2006) that use the term “portion”). Patent Owner also contends that a person of ordinary skill IPR2020-00649 Patent 9,192,395 B2 15 in the art would recognize that the “first and second force transmitting portions” of the robotic system of the challenged claims are the structural portions of the system that apply a force to move the legs of the staple toward each other. Id. at 29 (citing Riviere Second Decl. ¶¶ 45–54). We determine that on this record, Petitioner has not overcome the presumption that § 112, para. 6 does not apply. First, Petitioner has not persuaded us that “portion” is necessarily a nonce word. See, e.g., Zimmer Surgical, Inc. v. Stryker Corp., 2018 WL 30308515, *8 (D. Del. June 29, 2018) (“‘Portion’ is not a nonce word.”). Patent Owner demonstrates that prior art of record uses “portion” to refer to structure. For example, Hooven refers to the “business portion of the instrument” as the structure in the instrument that “accomplishes a step in a surgical procedure, whether that be ligating, stapling, cutting, manipulating tissue, or combinations of such steps.” Riviere Second Decl. ¶ 50 (quoting Ex. 1007, 4:21–32). Petitioner’s expert Dr. Fischer asserts that in Hooven, the word preceding the word “portion” provides the structure (see Fischer Supp. Decl. ¶ 13, discussing, e.g., “handle portion”), but this does not apply to Hooven’s use of the term “business portion of the instrument,” because “business” does not expressly recite structure. Second, “even if the claims recite a nonce term followed by functional language, other language in the claim ‘might inform the structural character of the limitation-in-question.’” MTD Prods. Inc. v. Iancu, 933 F.3d 1336, 1341–42 (Fed. Cir. 2019) (quoting Williamson, 792 F.3d at 1351). Petitioner narrowly focuses on the word “portion” while overlooking the larger context of the claims. The claims are directed to a robotic fastening system comprising elements configured to position a staple IPR2020-00649 Patent 9,192,395 B2 16 relative to a patient’s body. The fastening system includes a “fastening member having first and second force transmitting portions” that apply a force to move the staple legs towards each other. We agree with Dr. Riviere that persons of ordinary skill in the art would understand that the “first and second force transmitting portions” are structural parts of the fastening member. See Second Riviere Decl. ¶ 49. This is consistent with the Specification, which depicts “[f]orce transmitting members” as structures that move staple legs towards each other. See Ex. 1001, 26:52–56, 27:21– 23 (“Force transmitting members 312 and 314 (FIG. 21) are then moved by the robotic mechanism 38 to deflect the staple legs 306 and 308.”), Fig. 21, 29:51–60 (discussing “force transmitting members or lands 356 and 358 connected to the pusher plate 338”), Figs. 25, 26); Riviere Second Decl. ¶¶ 51–53. Thus, in the context of the challenged claims, we agree with Patent Owner that a person of ordinary skill in the art would have recognized the “first and second force transmitting portions” as connoting the structural portions of the fastening member that move the staple legs towards each other. See, e.g., Resp. 29; Riviere Second Decl. ¶¶ 49–53. As such, on this record, Petitioner has not overcome the presumption that § 112, ¶ 6 does not apply to the limitation “first and second force transmitting portions.” D. Summary of Asserted Prior Art References Below we summarize the prior art references that we discuss in detail herein. 1. Summary of Tierney (Ex. 1004), Madhani (Ex. 1009), and Cooper (Ex. 1010) Tierney incorporates Madhani and Cooper by reference. Ex. 1004, 1:60–66, 8:4–7. Accordingly, we discuss these references together. IPR2020-00649 Patent 9,192,395 B2 17 Tierney relates to “surgical tools having improved mechanical and/or data interface capabilities to enhance the safety, accuracy, and speed of minimally invasive and other robotically enhanced surgical procedures.” Ex. 1004, 1:12–15. Tierney describes that [r]obotic surgery will generally involve the use of multiple robotic arms. One or more of the robotic arms will often support a surgical tool which may be articulated (such as jaws, scissors, graspers, needle holders, microdissectors, staple appliers, tackers, suction/irrigation tools, clip appliers, or the like) or non-articulated (such as cutting blades, cautery probes, irrigators, catheters, suction orifices, or the like). Id. at 6:20–28. Tierney states that its robotic surgical system 10 generally includes master controller 150 and a robotic arm slave cart 50. Master controller 150 generally includes master controllers (not shown) which are grasped by the surgeon and manipulated in space while the surgeon views the procedure views [sic] a stereo display. The master controllers are manual input devices which preferably move with six degrees of freedom, and which often further have an actuatable handle for actuating tools (for example, for closing grasping saws, applying an electrical potential to an electrode, or the like). Id. at 6:61–7:4. IPR2020-00649 Patent 9,192,395 B2 18 Figure 2 of Tierney is reproduced below. Figure 2 above “is a perspective view of a robotic surgical arm cart system [50] in which a series of passive set-up joints support robotically actuated manipulators.” Id. at 5:29–31. The cart “includes a base 52 from which three surgical tools 54 are supported. More specifically, tools 54 are each supported by a series of manually articulatable linkages, generally referred to as set-up joints 56, and a robotic manipulator 58.” Id. at 7:16–21. In the cart, “robotic manipulators 58 preferably include a linkage 62 that constrains movement of tool 54,” and “linkage 62 includes rigid links coupled together by rotational joints in a parallelogram arrangement so that tool 54 rotates around a point in space 64.” Id. at 7:41–48. Manipulator 58 may include a cannula 72. Id. at 8:9–10. IPR2020-00649 Patent 9,192,395 B2 19 Figure 2A of Tierney is reproduced below. Figure 2A above is a perspective view of a robotic surgical manipulator 58 for use in the cart system of Figure 2. Tierney discloses that [l]inkage 62 of manipulator 58 is driven by a series of motors 70. These motors actively move linkage 62 in response to commands from a processor. Motors 70 are further coupled to tool 54 so as to rotate the tool about axis 66, and often to articulate a wrist at the distal end of the tool about at least one, and often two, degrees of freedom. Additionally, motors 70 can be used to actuate an articulatable end effector of the tool for grasping tissues in the jaws of a forceps or the like. Motors 70 may be coupled to at least some of the joints of tool 54 using cables, as more fully described in U.S. Pat. No. 5,792,135 [Madhani], the full disclosure of which is also incorporated herein by reference. As described in that reference, the manipulator will often include flexible members for transferring motion from the drive components to the surgical tool. For IPR2020-00649 Patent 9,192,395 B2 20 endoscopic procedures, manipulator 58 will often include a cannula 72. Cannula 72 supports tool 54, allowing the tool to rotate and move axially through the central bore of the cannula. Id. at 7:63–8:13 (emphasis added). Turning to Madhani, Madhani discloses a telesurgery system for laparoscopic surgery that “allows a surgeon at one location to perform surgery on a patient at another location.” Ex. 1009, 5:8–10. The system includes an “articulated surgical instrument for minimally invasive surgery which provides a high degree of dexterity, low friction, low inertia and good force reflection.” Id. at 1:15–19. The instrument is provided with a “unique cable and pulley drive system [that] operates to reduce friction and enhance force reflection” and a “unique wrist mechanism [that] operates to enhance surgical dexterity compared to standard laparoscopic instruments.” Id. at Abstract. According to Madhani, “laparoscopic surgical instruments generally include a laparoscope for viewing the surgical field, and working tools such as clamps, graspers, scissors, staplers, and needle holders.” Id. at 1:51–55. IPR2020-00649 Patent 9,192,395 B2 21 Figure 3 of Madhani is reproduced below. Figure 3 above is a perspective view of a force-reflecting surgical instrument 12 disclosed in Madhani. Id. at 48–49. Instrument 12 is controlled by a computer and a master device that is manipulated by a surgeon at a remote location. Id. at 5:13–16. Madhani’s system “has two opposed pivoting jaws and a pivoting wrist member [22],” and “is adapted to be coupled via a servomechanism to a master control operated by a surgeon.” Id. at 3:26–32. Madhani discloses that [o]nce instrument 12 is in the proper position, . . . the surgeon can perform the necessary surgical procedures on the patient with instrument 12. Forces experienced by instrument 12 are reflected back to the surgeon by master device 150 [not shown]. The reflected forces may be scaled up in order to allow the surgeon to better “feel” the surgical procedures. As a result, the surgeon can feel instrument 12 engaging types of tissue that do not provide much resistance. In addition, movements of master device 150 [not shown] relative to instrument 12 may be scaled down so that the precision and dexterity of instrument 12 can be increased. Id. at 7:20–32. IPR2020-00649 Patent 9,192,395 B2 22 Instrument 12 is driven by drive motors M1, M2, M3, M4, M5, M6 and M7 (FIGS. 3, 4, 6 and 7a-b) in conjunction with a series of cables and pulleys. Id. at 5:16–19. Madhani discloses that [d]rive motors M1, M2, M3, M4 and M5 are mounted to sliding bracket 96 and drive respective cables C1[,] C2, C3[,] C4 and C5. Sliding bracket 96 supports each of the drive motors. During operation sliding bracket 96 is connected to positioning mechanism 14 by mounting bracket 36. When instrument 12 is mounted on positioning mechanism 14, the drive motors operate to move distal portion 28b relative to sliding bracket 96. Sliding bracket 96 thus forms the support bracket of the surgical instrument. Each drive motor M1, M2, M3, M4 and M5 includes a respective encoder E1, E2, E3, E4 and E5 for providing computer 11 with the rotational position of their respective drive shafts. Id. at 8:28–39. Tierney also incorporates Cooper by reference, and cites Cooper’s disclosure of a multicomponent telepresence system and methods that improve the safety and speed with which robotic surgical tools can be removed and replaced during a surgical procedure. Ex. 1004, 1:60–2:11. Cooper “relates to robotically-assisted surgical manipulators and more particularly to systems and methods for performing telerobotic surgical procedures on a patient while providing the surgeon with the sensation of physical presence at the surgical site.” Ex. 1010, 1:17–21. Cooper describes design goals for its systems to include “easy sterilization so that they can be reused after the components have been contaminated during an operation,” and “to minimize instrument exchange time during the surgical procedure.” Id. at 3:4–8. IPR2020-00649 Patent 9,192,395 B2 23 2. Summary of Hooven (Ex. 1007) Hooven discloses an endoscopic stapling and cutting instrument that is interconnected with a controller and a video display monitor. Ex. 1007, 4:6–8. Hooven’s device “will place down plural parallel rows of staples with the staples offset in the rows. The instrument will also operate a knife to pass between two adjacent parallel rows of staples. Such an instrument staples tissue together and cuts that tissue between the stapled portions.” Id. at 4:34–40. Figures 1 and 3, annotated by Petitioner and reproduced below, illustrate several components of Hooven’s system. Figure 1 above “is a schematic view of an endoscopic surgical system of the present invention interconnected with a microprocessor/controller and a video display screen.” Id. at 3:14–16. Figure 3 above “is a longitudinal IPR2020-00649 Patent 9,192,395 B2 24 cross-sectional view of the handle portion of one embodiment of an endoscopic stapling and cutting system of the present invention.” Id. at 3:18–20. Petitioner’s annotations label the controller, endoscopic stapling and cutting instrument, and the instrument’s motor. 3. Summary of Whitman (Ex. 1008) Whitman discloses “an electro-mechanical surgical device” with a housing, an elongated shaft extending from the housing, an elongated shaft coupleable to a surgical instrument, at least two axially rotatable drive shafts within the shaft, a surgical instrument coupled to each of the drive shafts, a steering cable arrangement, and a motor system within the housing. Ex. 1008, 3:1–11. The system includes a first encoder 106 and a second encoder 108, which are configured to output a signal in response to and in accordance with the rotation of first and second drive shaft 30, 32, respectively. Id. at 7:56–60. Figure 8 of Whitman is reproduced below. IPR2020-00649 Patent 9,192,395 B2 25 Figure 8 is a schematic view of an encoder 106, 108. Whitman discloses that [m]ounted non-rotatably on drive shaft 30, 32 is a magnet 240 having a north pole 242 and a south pole 244. The encoder 106, 108 further includes a first sensor 246 and second sensor 248, which are disposed approximately 90° apart relative to the longitudinal, or rotational, axis of drive shaft 30, 32. The output of the sensors 246, 248 is persistent and changes its state as a function of a change of polarity of the magnetic field in the detection range of the sensor. Thus, based on the output signal from the encoders 106, 108, the angular position of the drive shaft 30, 32 may be determined within one-quarter revolution and the direction of rotation of the drive shaft 30, 32 may be determined. The output of each encoder 106, 108 is transmitted via a respective line 110, 112 of data transfer cable 38 to controller 122. The controller 122, by tracking the angular position and rotational direction of the drive shafts 30, 32 based on the output signal from the encoders 106, 108, can thereby determine the position and/or state of the components of the IPR2020-00649 Patent 9,192,395 B2 26 surgical instrument or attachment connected to the electro- mechanical surgical device 10. That is, by counting the revolutions of the drive shaft 30, 32, the controller 122 can determine the position and/or state of the components of the surgical instrument or attachment connected to the electro- mechanical surgical device 10. Id. at 8:5–29 (emphasis added). In one embodiment, Whitman discloses the use of a circular surgical stapler attachment that includes an anvil portion having an anvil mounted on the distal end of an anvil stem. Id. at 8:30–36. The anvil stem is extended and retracted by the operation of an anvil drive shaft. Id. at 8:36–38. The system is capable of determining whether the anvil has successfully moved between its extended and retracted positions. Id. at 8:38–41. E. Obviousness Analysis: Tierney, McGarry, Bonutti, Hooven and Whitman Petitioner contends that claims 1 and 4 are unpatentable over Tierney, McGarry, Bonutti, Hooven, and Whitman. Pet. 74–77. With the exception of the claimed position sensor (recited in claim 1 (limitation [1.6]) and in claim 4), Patent Owner does not dispute that the cited prior art teaches or suggests the limitations of claims 1 and 4. Although we need not make specific findings about claim limitations that Patent Owner does not dispute are disclosed in the prior art, see In re NuVasive, Inc., 841 F.3d 966, 974 (Fed. Cir. 2016), for completeness we set forth below how Petitioner has demonstrated that the cited prior art teaches or suggests each limitation of claims 1 and 4. We also address Patent Owner’s arguments regarding the claimed position sensor, and its arguments that Petitioner has not demonstrated a motivation to combine the prior art teachings with a reasonable expectation of success. IPR2020-00649 Patent 9,192,395 B2 27 For the reasons explained below, on this record we find that Petitioner establishes by a preponderance of the evidence that claims 1 and 4 are unpatentable as obvious. 1. Claim 1 (a) Limitation [1.1]: A robotic fastening system comprising: To the extent the preamble is limiting, we find that Petitioner establishes by a preponderance of the evidence that Tierney discloses a robotic fastening system. See Pet. 27–28 (citing, e.g., Ex. 1004, 6:20–37, 6:61–63, 7:16–18, 9:8–15, 9:66–10:11, 11:66–12:29, Figs. 1–4, 5F), 58; Fischer Decl. ¶¶ 67–69. For example, Tierney discloses a robotic surgical system, which can include a stapler. Pet. 27–28; see also Ex. 1004, Fig. 1 and 5:24–28 (disclosing robotic surgical system 10), 6:22–28 (teaching use of staple appliers in the robotic surgical system). (b) Limitation [1.2]: a robotic mechanism including an adaptive arm configured to position a staple relative to a body portion of a patient; Petitioner establishes by a preponderance of the evidence that Tierney discloses this limitation. Pet. 29–31 (citing, e.g., Fischer Decl. ¶¶ 70–71), 58. For example, Petitioner’s annotated version of Tierney Figure 3A, which exemplifies a portion of Tierney’s robotic surgical system, is reproduced below: IPR2020-00649 Patent 9,192,395 B2 28 In the annotated version of Tierney Figure 3A above, Petitioner highlights that robotic cart 50 includes an arm having a set up joint 56 and robotic manipulator 58. Pet. 30. The figure also shows surgical tool 54, which Tierney teaches can be a staple applier. Ex. 1004, 6:20–28. Petitioner persuasively maps these features in Tierney to the “adaptive arm” recited in claim 1. Pet. 29–31; Fischer Decl. ¶¶ 70–71. IPR2020-00649 Patent 9,192,395 B2 29 (c) Limitation [1.3]: a robotic arm interface configured to operate the adaptive arm of the robotic mechanism; Petitioner establishes by a preponderance of the evidence that Tierney discloses this limitation, e.g., by disclosing “master controllers” configured to operate the adaptive arm of the robotic mechanism. Pet. 31 (citing, e.g., Ex. 1004, 6:63–7:6, 11:66–12:64; Fischer Decl. ¶ 72), 58. (d) Limitation [1.4]: a staple having first and second legs; Petitioner establishes by a preponderance of the evidence that Tierney in view of Hooven discloses this limitation.11 Pet. 58–59. Both Tierney and Hooven disclose a stapler, and a person of ordinary skill in the art would have understood that a staple generally has first and second legs. Ex. 1004, 6:25; Ex. 1007, 4:34–37; Fischer Decl. ¶ 135; Pet. 59. Petitioner also establishes that Hooven’s stapler applies staples having first and second legs. Fischer Decl. ¶ 136; Pet. 59. (e) Limitation [1.5]: a fastening member coupled to the adaptive arm, the fastening member having first and second force transmitting portions and configured to secure the body portion with the staple by applying a force from the first and second force transmitting portions to move the first and second legs of the staple toward each other; With respect to “a fastening member coupled to the adaptive arm,” Petitioner establishes that the surgical tool resulting from adapting Hooven’s stapler for use with Tierney’s robotic system has an interface that mechanically and electrically couples the tool to the adaptive arm. Pet. 62– 63; Fischer Decl. ¶ 145. 11 As discussed below in Section II.E.1(h), Petitioner establishes by a preponderance of the evidence that a person of ordinary skill in the art would have been motivated to combine Tierney’s robotic system and Hooven’s stapler. IPR2020-00649 Patent 9,192,395 B2 30 Petitioner also establishes that the Tierney/Hooven stapler teaches or suggests the remainder of this limitation (“the fastening member having first and second force transmitting portions . . . to move the first and second legs of the staple toward each other”). Pet. 62–63; Fischer Decl. ¶ 145. Petitioner’s annotated version of Hooven Figure 8 is reproduced below: Petitioner’s annotated version of Hooven Figure 8, reproduced above, depicts Hooven’s stapler, with Petitioner’s annotations calling out the first force transmitting portion (“staple drivers 84,” shown in yellow), the second force transmitting portion (“anvil 75,” shown in blue), and the fastener (“staple 81”). In operation, a motor drives a wedge-shaped sliding mechanism (driving wedge 83) along the length of the stapler and a drive screw (e.g., threaded rod 71) moves staple drivers 84 (yellow) and staple 81 toward anvil 75 (blue). Pet. 64–65; Ex. 1007, 5:62–6:3; Fischer Decl. ¶¶ 146–47. This moves the staple legs together to secure the body portion. IPR2020-00649 Patent 9,192,395 B2 31 (f) Limitation [1.6]: at least one of a position sensor configured to indicate a distance moved by the staple and a force measurement device configured to indicate a resistance required to move the staple relative to the body portion; and (i) at least one of a position sensor configured to indicate a distance moved by the staple With respect to the limitation “at least one of a position sensor configured to indicate a distance moved by the staple,” Petitioner establishes that both Hooven and Whitman disclose such a position sensor.12 Pet. 69– 70, 75–76. Specifically, Hooven discloses a position sensor (contact 87) which can indicate the distance Hooven’s staple 81 moves from its initial position inside the cartridge to its driven position. Id. at 69 (citing Fischer Decl. ¶¶ 154–55; Ex. 1007, 6:16–19, Fig. 7). Contact 87 is engaged when the firing nut has moved to its most forward position after driving and forming the staples. Ex. 1007, 6:16–19. Thus, when contact 87 is activated at the end of the firing stroke, it will indicate the position of the firing nut 86 and driving wedge 83, thereby indicating that staple 81 has been moved the distance between its initial position inside the cartridge and its driven position. Fischer Decl. ¶ 155. Hooven also teaches sensing the movement of the firing nut as it travels along the threaded rod (id.; Ex. 1007, 6:33–47), which would similarly track the position of the staple. 12 Petitioner also argues that Tierney (via its incorporation by reference of Madhani) discloses the claimed position sensor, i.e., by disclosing motor encoders configured to indicate a distance moved by the fastener. Pet. 66–69. Because we find that each of Hooven and Whitman adequately discloses the claimed position sensor, and find that a person of ordinary skill in the art would have been motivated to combine this aspect of Whitman with the Tierney/Hooven system, we need not and do not reach Petitioner’s other argument based on Tierney/Madhani. IPR2020-00649 Patent 9,192,395 B2 32 Patent Owner argues that Hooven’s contact 87 is not a position sensor because (i) “it is not active during formation of any staples;” (ii) “its output is not a position” but rather a binary (yes/no) indication of whether the firing nut has moved to its most forward position; and (iii) it “does not sense the distance moved by any staple,” but rather senses the distance moved by the firing nut. Resp. 68–69 (quoting Riviere Second Decl. ¶ 238; citing id. ¶¶ 239–40 and Ex. 1007, 6:16–22). Patent Owner’s arguments are unavailing. Regarding (i), we see nothing in the language of claim 1, nor have the parties pointed us to anything in the Specification, that requires the claimed position sensor to be “active during formation of any staples.” Reply 22–23; Fischer Supp. Decl. ¶ 109. Regarding (ii) and (iii), we similarly see nothing in the language of claim 1, nor have the parties pointed us to anything in the Specification, that excludes determining the position of the staple by proxy. Indeed, Hooven’s disclosure relating to contact 87 is consistent with the description of the position sensor in the ’395 patent, which indicates that sensor 452 “has an output which is indicative of the position of the fastener drive member 446,” rather than of the position of the fastener itself. Ex. 1001, 36:45–50, Fig. 34; Fischer Decl. ¶ 155; Fischer Supp. Decl. ¶¶ 108, 110. Nevertheless, we also find that Whitman discloses a position sensor as claimed, i.e., controller 122 and encoders 106, 108. See Fischer Decl. ¶ 169. Whitman teaches that “controller 122, by tracking the angular position and rotational direction of the drive shafts 30, 32 based on the output signal from the encoders 106, 108 can thereby determine the position and/or state of the components of the surgical instrument or attachment connected to the electro-mechanical surgical device 10.” Ex. 1008, 8:20–25. In particular, IPR2020-00649 Patent 9,192,395 B2 33 because the pitch of the drive shaft is known, the position of the stapler is a function of, and ascertainable on the basis of, the rotation of the drive shaft. Id. at 8:55–9:1; Fischer Decl. ¶¶ 169–70. As Dr. Fischer establishes, a person of ordinary skill in the art would have immediately understood that position sensors could be used to sense the position of each of the components moved by the motors, and thus would measure the distance moved by the staple. Fischer Decl. ¶ 173. Patent Owner does not dispute that Whitman discloses a position sensor as claimed, but rather argues that a person of ordinary skill in the art would not have been motivated to combine Whitman’s position sensor with Tierney and Hooven with a reasonable expectation of success. See Resp. 72–76. We address those arguments in Section II.E.1(h)(ii) below. (ii) a force measurement device configured to indicate a resistance required to move the staple relative to the body portion Petitioner establishes that Tierney in view of Hooven discloses this limitation. See Pet. 70–71 (citing, e.g., Fischer Decl. ¶¶ 156–58). In particular, Hooven discloses a force measurement device (e.g., the sensor circuits in Hooven’s controller 31 and/or the sensors in Hooven’s end effector) configured to indicate (via signals sent to the “logic circuits” in controller 31) a resistance required to move the fastener relative to the body portion (“the power and/or force being used” by drive motor 45 to move driving wedge 83 and fire staple 81). Fischer Decl. ¶ 156; Ex. 1007, 8:29– 32. The force to move the staple would be the same as the resistance to movement due to the body tissue felt by the staple.13 Fischer Decl. ¶ 156. 13 Petitioner also argues that Tierney (via its incorporation by reference of Madhani) discloses the claimed force measurement device. Pet. 71–72. Because IPR2020-00649 Patent 9,192,395 B2 34 (g) Limitation [1.7]: a tissue retractor assembly coupled to the robotic mechanism, the tissue retractor assembly including a cannula configured to facilitate insertion of the fastening member through the cannula into a working space inside the patient. Petitioner establishes that Tierney’s cannula 72 is configured to facilitate insertion of the Tierney/Hooven stapler through the cannula into a working space inside the patient.14 Pet. 72 (citing Fischer Decl. ¶ 159). (h) Motivation to Combine with a Reasonable Expectation of Success (i) Combining Tierney’s Robotic System and Hooven’s Stapler Petitioner persuasively establishes that a person of ordinary skill in the art would have been motivated to modify Tierney’s robotic system to accommodate Hooven’s stapler. See Pet. 59–61 (additionally cross- referencing id. at 37–40); see also In re Venner, 262 F.2d 91, 95 (C.C.P.A. 1958) (holding that broadly providing an automatic means to replace a manual activity that accomplishes the same result is insufficient to distinguish over the prior art). Tierney teaches using its robotic system with “any . . . end effector which is useful for surgery,” including “staple appliers.” Pet. 37, 60–61; Fischer Decl. ¶¶ 82, 139; Ex. 1004, 6:22–28, we find that Hooven adequately discloses the claimed force measurement device, we need not and do not reach this other argument. 14 Petitioner also establishes that Bonutti discloses a retractor mounted on a cannula, and that it would have been obvious in view of Bonutti to modify Tierney’s cannula 72 to include a tissue retractor. Ex. 1006, Abstract, 3:57–58, 9:47–49, Fig. 21; Pet. 74–77 (citing, e.g., Fischer Decl. ¶ 168 (“Tierney/Hooven/Whitman would disclose claim 4, and with the addition of Bonutti ’136, would disclose claim 1.”)); see also Pet. 54–57 (citing, e.g., Fischer Decl. ¶¶ 125–30). IPR2020-00649 Patent 9,192,395 B2 35 10:8–11. Petitioner establishes that a person of ordinary skill in the art would have turned to Hooven for details on how to implement Tierney’s robotic system with a stapler. Pet. 37, 60–61; Fischer Decl. ¶ 83. Petitioner also establishes that a person of ordinary skill in the art would have known the benefits of using Tierney’s robotic system, including more rapid tool changes, which leads to enhanced safety and reliability, and increased accuracy and surgical dexterity compared to using manual instruments such as Hooven’s stapler. Pet. 37–38, 60–61; Fischer Decl. ¶¶ 82, 87; Ex. 1019, 2:16–55; Ex. 1004, 2:28–35. And Petitioner establishes that adaptation of handheld surgical tools like Hooven’s stapler for use with robotic systems like Tierney’s was well known and routine in the art. Pet. 39 (citing Fischer Decl. ¶¶ 88–92 (discussing prior art examples of adapting handheld tools for use with robotic surgical systems)). Moreover, Tierney and Hooven have the common objectives of allowing for a high degree of control of end effectors, which would have motivated a person of ordinary skill in the art to implement the computer-control features of Hooven’s stapler in Tierney’s robotic system, to obtain a high degree of control (and the ensuing safety benefits) over the resulting robotic surgical stapler. Id. at 61; Fischer Decl. ¶¶ 93–95, 139; Ex. 1004, 1:12–16; Ex. 1007, 2:24–27. Petitioner establishes that a person of ordinary skill in the art would have reasonably expected the Tierney/Hooven combination to be successful, including because adapting a surgical instrument like Hooven’s stapler for use with a robotic system like Tierney’s was well within the level of ordinary skill in the art, and merely the application of a known technique (e.g., adapting manually controlled components for use with a robotic system) with known devices (Hooven’s stapler and Tierney’s surgical IPR2020-00649 Patent 9,192,395 B2 36 robot), where each device in the combined system performs the same predictable function as it does separately. Fischer Decl. ¶¶ 97, 140 (discussing prior art examples of converting handheld tools for robotic surgical systems); see also Pet. 40–41, 61–62; KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007) (“[A] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.”). Dr. Fischer explains that a person of ordinary skill in the art would have known how to make mechanical linkages between Tierney’s driven elements and Hooven’s moveable components, e.g., by using gears. Fischer Decl. ¶¶ 97, 99, 140–42; see also Pet. 40–41, 61–62. We find Petitioner’s rationales regarding why a person of ordinary skill in the art would have been motivated to combine Tierney’s and Hooven’s teachings with a reasonable expectation of success to be reasonable and supported by the cited evidence and expert testimony. Nevertheless, Patent Owner raises several arguments regarding a lack of motivation to combine and reasonable expectation of success. We address each argument below. Patent Owner recognizes that Petitioner provides two options for combining Tierney and Hooven, which it designates as Options (1) and (2). These options vary with respect to the motor used to provide the forces needed to operate the end effector (stapler). Fischer Decl. ¶ 137; Resp. 58, 59–61. In Option (1), Hooven’s motor is incorporated into Tierney’s housing and shaft. Fischer Decl. ¶ 137; Resp. 58–60; Pet. 60; Riviere Second Decl. ¶ 198. In Option (2), Tierney’s motor is used.15 Fischer Decl. ¶¶ 137, 140, 141; Resp. 60–61; Pet. 60; Riviere Second Decl. ¶ 199. 15 Because we find that Petitioner establishes unpatentability by a preponderance of IPR2020-00649 Patent 9,192,395 B2 37 Patent Owner argues that “Option (1) fails” because it moves Hooven’s motor into Tierney’s housing, but a person of ordinary skill in the art “would have known to avoid incorporating a motor into the housing of Tierney’s sterilizable tool because sterilization occurs at high temperatures that would render the motor inoperable for re-use of the tool.” Resp. 60 (citing Ex. 1004, 10:25–32); Riviere Second Decl. ¶ 218. We find this argument unavailing. Tierney indicates that surgical tools “will generally be sterile structures,” and does not require sterilization using high temperatures. Ex. 1004, 10:25–32 (emphasis added). Indeed, the record indicates that surgical tools can be disposable, and that motors can be sterilized using means other than high temperatures. See Fischer Supp. Decl. ¶¶ 92–94; Ex. 1033, 1:12–28 (describing sterilization of articles using gaseous plasmas); Ex. 1007, 2:32–34 (indicating that components may be disposable). Patent Owner also argues a lack of motivation to combine Tierney and Hooven because the combination would change the “basic principles under which Tierney was designed to operate.” Resp. 62. First, Patent Owner argues that the tools in Tierney’s system “have a rigid shaft,” but Hooven’s hand-held stapler has an “axially flexible shaft,” which could cause unexpected and unsafe stapler movement. Id. at 63 (citing Riviere Second Decl. ¶¶ 143, 203–06). This argument is unavailing, because as shown in Petitioner’s composite figure reproduced below, the proposed combination uses Tierney’s shaft: the evidence based on “Option (1),” we need not and do not reach the parties’ arguments regarding “Option (2).” IPR2020-00649 Patent 9,192,395 B2 38 The composite figure above shows Hooven’s stapler attached to Tierney’s rigid shaft 102. Pet. 60; Ex. 1004, 9:8–10 (describing rigid shaft 102); see also Fischer Decl. ¶ 137 (presenting same composite figure); Reply 20 (confirming that the proposed combination uses Tierney’s rigid shaft); Fischer Supp. Decl. ¶¶ 95–97 (explaining same); Riviere Second Decl. ¶ 205 (acknowledging that under Petitioner’s arguments, use of Tierney’s rigid shaft is possible, and thus acknowledging that the proposed combination does not require use of Hooven’s flexible shaft). Patent Owner also argues that ordinarily skilled artisans would not have combined Tierney and Hooven because “wrist articulation, which is important for the safe operation of a robotic stapler, is completely missing” in the combination.16 Resp. 63; see also Sur-reply 15. Patent Owner argues that “[r]emoving the hand-held feature of Hooven’s stapler and Tierney/Madhani’s cables and pulleys eliminates both Hooven’s desired 16 In its Sur-reply, Patent Owner raises a new argument that neither of Petitioner’s designs (Options 1 or 2) “provide[s] for rotation of the linear stapler.” See Sur- reply 15–17. This argument comes too late. Petitioner presented the combination of Tierney and Hooven in the Petition, and thus Patent Owner could have, and should have, raised this argument in its Patent Owner Response. 37 C.F.R. § 42.23(b). IPR2020-00649 Patent 9,192,395 B2 39 high degree of control in manipulating the linear stapler by hand and Tierney’s dexterity resulting from wrist articulation while increasing friction, inertia, complexity, weight and size contrary to the express teachings of Tierney/Madhani.” Resp. 64 (citing, e.g., Riviere Second Decl. ¶¶ 207–11). Patent Owner contends that an ordinarily skilled artisan “would not have had a reasonable expectation of success knowing that a surgeon would be unable to properly position the linear stapler in many applications without Hooven’s hand-held feature or Tierney/Madhani’s wrist articulation.” Id. Patent Owner’s arguments are unavailing. First, although Tierney contemplates use of staplers with its system, we see nothing in Tierney that requires use of a wrist with a stapler. See, e.g., Ex. 1004, 7:65–8:1 (teaching that the system “often” “articulate[s] a wrist”); see also id. at dependent claims 5, 8, 16, 25, 28 (specifying, in contrast to the broader independent claims from which they depend, that the end effector is coupled to the probe with a wrist); Reply 20–21. Second, the prior art shows that a wrist is not required for a robotic stapler. See, e.g., Ex. 1018, Figs. 3–8; Fischer Supp. Decl. ¶ 98 (noting that although a wrist may provide benefits, the prior art shows that it is not required for a robotic stapler); Reply 20–21.17 Indeed, consistent with the prior art teaching robotic staplers without a wrist, challenged claims 1 and 4 do not recite a wrist. Finally, although Dr. Riviere testifies that “the surgeon would be unable to properly position the linear stapler in many applications” without wrist articulation, he is not a 17 We need not and do not address either Petitioner’s alternative argument that an ordinarily skilled artisan could have used Hooven’s flexible shaft as “an alternative to a wrist,” or Patent Owner’s responses to this argument. Reply 21; Resp. 64–65. IPR2020-00649 Patent 9,192,395 B2 40 surgeon (see Riviere Decl. ¶ 2), and does not cite any evidence to corroborate this testimony. See In re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”). Accordingly we do not credit Dr. Riviere’s testimony on this point. Patent Owner also argues that there is “no disclosure in Tierney/Madhani that would have motivated a [person of ordinary skill in the art] to use any drive system other than a cable and pulley drive system,” which is advantageous for rigid robotic tools. Resp. 66 (citing Riviere Second Decl. ¶¶ 213–14); see also id. at 65–66 (arguing that “[r]emoving the cables and pulleys . . . would have been inconsistent with the objects of the invention and the principles of operation of Tierney/Madhani”), 67. This argument is unavailing because it mischaracterizes Tierney. Tierney is not limited to use of Madhani’s cable system, but instead expressly discloses that mechanical linkages can be made via “cabling arrangements, drive chains or belts, hydraulic drive systems, gear trains, or the like.”18 Ex. 1005, 9:31–45; Fischer Supp. Decl. ¶ 104. Additionally, Patent Owner’s argument that the proposed combination would have resulted in a loss of control of Hooven’s stapler is unavailing. Resp. 64. To the contrary, Dr. Fischer explains that the robotic arm would 18 Patent Owner and Dr. Riviere appear to suggest that Tierney only discloses cable and pulley drive systems because Tierney’s Fig. 4B, which Tierney identifies as an “alternative drive system” (Ex. 1004, 9:44–45), also uses cables and pulleys. See, e.g., Resp. 47; Riviere Second Decl. ¶ 213 (citing Ex. 1004, 9:30–45). This argument is unavailing. Tierney unambiguously discloses “gear trains” among a number of “alternative drive systems.” Ex. 1004, 9:30–33. IPR2020-00649 Patent 9,192,395 B2 41 hold the instrument steadier than a surgeon’s hand, and the use of the motors in the robotic system to actuate the stapler reduces the forces required for the surgeon to apply to the instrument. Fischer Supp. Decl. ¶¶ 100, 102. Moreover, even if Petitioner’s proposed combination did result in some loss of a desired “dexterity and other advantages built into the Tierney/Madhani [cable and pulley] drive system,” “a given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate a motivation to combine.” Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165 (Fed. Cir. 2006). Here, Petitioner adequately establishes that incorporating Hooven’s handheld tool into Tierney’s robotic system would have resulted in benefits including increased accuracy compared to manually operated instruments, and would have allowed the surgeon to use Tierney’s robotic system throughout surgery, rather than having to switch to Hooven’s handheld tool. See Pet. 37–38 (addressing benefits of surgical robots), 60–62; Reply 21–22; Fischer Supp. Decl. ¶ 102. Patent Owner has not shown that any purported loss of dexterity would have outweighed the anticipated benefits of the combined system sufficient to undermine Petitioner’s showing. Finally, Patent Owner argues “there is not enough space for the proposed additional components from Hooven’s shaft in the shaft 102 of Tierney.” Resp. 66 (citing Riviere Decl. ¶¶ 219–221). This argument is unavailing because Patent Owner has not established a basis for arguing that the diameter of Tierney’s shaft is too small to accommodate the additional components from Hooven. Patent figures are not drawn to scale unless otherwise stated. Hockerson-Halberstadt, Inc. v. Avia Group Int’l, 222 F.3d 951, 956 (Fed. Cir. 2000). It is undisputed that Tierney does not provide IPR2020-00649 Patent 9,192,395 B2 42 dimensions for its drawings or otherwise disclose the dimension of its shaft. Reply 6; Fischer Supp. Decl. ¶ 44; Ex. 1024, 45:6–8. Moreover, Dr. Fischer establishes that different sized shafts were available, and a person of ordinary skill in the art would have understood how to appropriately size the shaft to fit the necessary components. Fischer Supp. Decl. ¶¶ 44, 48, 49, 105; see also KSR, 550 U.S. at 421 (“A person of ordinary skill is also a person of ordinary creativity, not an automaton.”). (ii) Combining Tierney’s Robotic System and Hooven’s Stapler with Whitman’s Position Sensor As discussed above, both Hooven and Whitman disclose a position sensor. See Section II.E.1.(f). Petitioner persuasively establishes that as an alternative to using Hooven’s position sensor, a person of ordinary skill in the art would have been motivated to combine Whitman’s position sensor with the Tierney/Hooven system. Fischer Decl. ¶ 172. For example, Whitman teaches that the position sensor allows selective enabling or disabling of the robotic system based on the positions of the components of the surgical instrument, and allows Tierney’s controller to determine whether there was an error during retraction of the staple driver. Pet. 76; Fischer Decl. ¶¶ 171–72; Ex. 1008, 12:42–47 (confirming that the gap between the anvil and the body portion of the stapler may be determined using the output of signal encoders on the corresponding motor drive shaft), 15:60–16:23 (confirming that the system can determine whether retraction of the staple/drive cutter is complete using the output of signal encoders). In addition to the reasons discussed above why a person of ordinary skill in the art would have been motivated to combine Tierney and Hooven with a reasonable expectation of success, Petitioner also establishes that a person of ordinary skill in the art would have been motivated to combine IPR2020-00649 Patent 9,192,395 B2 43 Whitman with Tierney and Hooven. Pet. 76–77; Fischer Decl. ¶ 173. Specifically, the combination would have been merely the application of a known technique (tracking the position of the drives shafts based on the output signal from the encoders to determine the position and/or state of the components of the surgical instrument as taught by Whitman) with the Tierney/Hooven system in the same field of endeavor (robotically controlled surgical staplers). Pet. 76–77; Fischer Decl. ¶ 173; KSR, 500 U.S. at 417 (“[I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill.”). Each system would continue to perform the same predictable functions as it does separately without significantly altering or hindering the functions performed by the Tierney/Hooven system (e.g., clamping, cutting, and stapling). Pet. 77; Fischer Decl. ¶ 173. Patent Owner argues that a person of ordinary skill in the art would not have been motivated to combine Whitman (which requires “an extremely flexible shaft”) with Hooven (which requires “a semi-rigid shaft”) and Tierney (which requires a rigid shaft), with a reasonable expectation of success. Resp. 72 (citing, e.g., Riviere Second Decl. ¶¶ 258–59). Patent Owner also argues that incompatibility between the cables of Whitman and Tierney would cause a loss of control of Tierney’s end effector and Whitman’s shaft. Id. at 73 (citing Riviere Second Decl. ¶ 259). These arguments are unavailing, because the proposed combination does not include Whitman’s shaft, Hooven’s shaft, or Tierney’s cables. Reply 20, 23–24; Fischer Supp. Decl. ¶ 112. IPR2020-00649 Patent 9,192,395 B2 44 Finally, Patent Owner argues that the position sensor in Whitman “requires a torsionally stiff drive shaft,” but a person of ordinary skill in the art would not have been able to pass such a drive shaft through a wrist. Resp. 73–74 (citing, e.g., Riviere Second Decl. ¶¶ 260, 207–11; Ex. 1008, 8:5–9:8; Ex. 2004, 114:15–119:19). This argument is unavailing because, as discussed above, the Tierney/Hooven combination does not require a wrist. See also Reply 24; Fischer Supp. Decl. ¶ 113. (i) Summary as to Claim 1 As discussed above, Petitioner’s analysis addresses every limitation in claim 1 and provides reasons with rational underpinning as to why a person of ordinary skill in the art would have been motivated to combine the cited prior art teachings with a reasonable expectation of success. Thus, based on the trial record, and taking into account Patent Owner’s arguments, we find that Petitioner has demonstrated by a preponderance of the evidence that claim 1 is unpatentable under 35 U.S.C. § 103(a) as obvious. 2. Claim 4 Claim 4 is similar to claim 1, with the primary difference being that claim 1 requires a “tissue retractor assembly” whereas claim 4 does not, and claim 4 requires an endoscope and an imaging device whereas claim 1 does not. Resp. 57; Riviere Second Decl. ¶ 180. Petitioner demonstrates that Tierney discloses the endoscope and imaging device recited in claim 4. Pet. 73 (cross-referencing id. at 32–34); Fischer Decl. ¶¶ 73–75, 164. Other than this difference, Petitioner’s arguments regarding obviousness of claim 4 over Tierney, Hooven, and Whitman are similar to the arguments discussed above for claim 1. See Pet. 73–77. Apart from its arguments already IPR2020-00649 Patent 9,192,395 B2 45 discussed above with respect to claim 1, Patent Owner does not provide additional arguments specific to claim 4. See generally Resp. Accordingly, for the reasons discussed above, we find that Petitioner has demonstrated by a preponderance of the evidence that claim 4 is unpatentable under 35 U.S.C. § 103(a) as obvious. F. Remaining Grounds In view of our determination that claims 1 and 4 would have been obvious as discussed above, we need not and do not address Petitioner’s additional grounds of unpatentability. See, e.g., SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1359 (2018) (holding a petitioner “is entitled to a final written decision addressing all of the claims it has challenged”); Boston Sci. Scimed, Inc. v. Cook Grp. Inc., Nos. 2019-1594, -1604, -1605, 2020 WL 2071962, at *4 (Fed. Cir. Apr. 30, 2020) (non-precedential) (recognizing that the “Board need not address issues that are not necessary to the resolution of the proceeding” and, thus, agreeing that the Board has “discretion to decline to decide additional instituted grounds once the petitioner has prevailed on all its challenged claims”). III. PATENT OWNER’S MOTION TO EXCLUDE Patent Owner moves to exclude (i) Exhibits 1026 through 1037; and (ii) paragraphs 23–26, 28–30, 36, 49, 54–57, 60, 61, 63, 64, 76, 92, and 99 of Dr. Fischer’s Supplemental Declaration (Exhibit 1025), as well as any reference to or reliance on these paragraphs in the Reply.19 Paper 23, i. Patent Owner argues that this evidence supports Petitioner’s prima facie 19 Patent Owner also requested that the Board preclude Petitioner from using all evidence and arguments that are the subject of its Motion at any hearing. Mot. 1. Because the hearing has already taken place, we dismiss this request as moot. IPR2020-00649 Patent 9,192,395 B2 46 case of obviousness, and thus comes too late because it was not cited in the Petition, but rather first cited in the Reply. Id. at 2. Petitioner responds that the Reply does not seek to fill alleged gaps in the Petition, but rather responds to arguments raised in the Patent Owner Response. Paper 24, 1. Patent Owner, as the moving party, bears the burden of establishing that it is entitled to the requested relief. 37 C.F.R. §§ 42.20(c), 42.62(a). We determine that Patent Owner has not met its burden. As an initial matter, the Board has advised that a motion to exclude should not be used to “address arguments or evidence that a party believes exceeds the proper scope of reply.” See Patent Trial and Appeal Board Consolidated Trial Practice Guide (November 2019) (“TPG” 20) 79; see also Paper 24, 2. However, even if we consider Patent Owner’s arguments on the merits, we find them unavailing. For the reasons advanced by Petitioner, which we adopt, we find that the subject evidence is not used to present a prima facie showing of obviousness, fill any alleged gaps in Petitioner’s obviousness grounds, or support a new motivation to combine, but rather is properly presented to rebut arguments Patent Owner advanced in its Response. See Paper 24, 6–15. Patent Owner also contends that the timing of Petitioner’s introduction of these exhibits and the related testimony prevented Patent Owner “from mounting a complete and fair defense.” Paper 23, 8; see also id. at 7–9. However, we agree with Petitioner that there is nothing inherently improper with submitting evidence after the patent owner response, and in fact, such submission is expressly contemplated by the TPG. See TPG 73 (stating that a party “may submit rebuttal evidence in 20 Available at https://www.uspto.gov/TrialPracticeGuideConsolidated. IPR2020-00649 Patent 9,192,395 B2 47 support of its reply”); Paper 24, 5. Patent Owner had an opportunity to depose Petitioner’s expert and to submit a sur-reply addressing the evidence it seeks to exclude, and also had the opportunity to request leave to submit a supplemental declaration from its own expert. See, e.g., IPR2020-00051, Paper 33 at 5 (authorizing patent owner to file a supplemental declaration after the petitioner’s reply). For the above reasons, we deny Patent Owner’s motion to exclude. IPR2020-00649 Patent 9,192,395 B2 48 IV. CONCLUSION21 Based on the information presented, we conclude that Petitioner has shown by a preponderance of the evidence that claims 1 and 4 are unpatentable under 35 U.S.C. § 103(a) as obvious. In summary: 21 Should Patent Owner wish to pursue amendment of the challenged claims in a reissue or reexamination proceeding subsequent to the issuance of this decision, we draw Patent Owner’s attention to the April 2019 Notice Regarding Options for Amendments by Patent Owner Through Reissue or Reexamination During a Pending AIA Trial Proceeding. See 84 Fed. Reg. 16,654 (Apr. 22, 2019). If Patent Owner chooses to file a reissue application or a request for reexamination of the challenged patent, we remind Patent Owner of its continuing obligation to notify the Board of any such related matters in updated mandatory notices. See 37 C.F.R. § 42.8(a)(3), (b)(2). 22 We do not address Petitioner’s grounds based on Tierney and McGarry. 23 We do not address Petitioner’s ground based on Tierney, McGarry, and Bonutti. 24 We do not address Petitioner’s ground based on Tierney and Hooven. 25 We do not address Petitioner’s ground based on Tierney, McGarry, Bonutti, Hooven, Whitman, Madhani, and Cooper. Claims 35 U.S.C. § Reference(s)/Basis Claims Shown Unpatentable Claims Not shown Unpatentable 1, 4 103(a) Tierney, McGarry22 1 103(a) Tierney, McGarry, Bonutti23 1, 4 103(a) Tierney, Hooven24 1, 4 103(a) Tierney, McGarry, Bonutti, Hooven, Whitman 1, 4 1, 4 103(a) Tierney, McGarry, Bonutti, Hooven, Whitman, Madhani, Cooper25 Overall Outcome 1, 4 IPR2020-00649 Patent 9,192,395 B2 49 V. ORDER In consideration of the foregoing, it is hereby: ORDERED that claims 1 and 4 of U.S. Patent 9,192,395 B2 have been shown by a preponderance of the evidence to be unpatentable; FURTHER ORDERED that Patent Owner’s Motion to Exclude is denied; and FURTHER ORDERED that, because this is a final written decision, parties to this proceeding seeking judicial review of our Decision must comply with the notice and service requirements of 37 C.F.R. § 90.2. IPR2020-00649 Patent 9,192,395 B2 50 For PETITIONER: Steven Katz John Phillips Ryan O’Connor FISH & RICHARDSON P.C. katz@fr.com phillips@fr.com oconnor@fr.com For PATENT OWNER: Robert Evans, Jr. Michael J. Hartley Kathleen Markowski Petrillo LEWIS RICE LLC revans@lewisrice.com mhartley@lewisrice.com kpetrillo@lewisrice.com Copy with citationCopy as parenthetical citation