`
`Frederick E. Shelton, IV
`Patent of:
`8,479,969
`
`
`U.S. Pat. No.:
`July 9, 2013
`Issue Date:
`Appl. Serial No.: 13/369,609
`Filing Date:
`Feb. 9, 2012
`Title:
`DRIVE INTERFACE FOR OPERABLY COUPLING A
`MANIPULATABLE SURGICAL TOOL TO A ROBOT
`
`Attorney Docket No.: 11030-0049IP9
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`
`DECLARATION OF DR. BRYAN KNODEL IN SUPPORT OF PETITION
`FOR INTER PARTES REVIEW OF U.S. PATENT NO. 8,479,969
`(PRISCO AS PRIMARY REFERENCE)
`
`
`
`
`
`
`
`
`
`1
`
`IS 1003
`
`
`
`U.S. Patent No. 8,479,969
`
`TABLE OF CONTENTS
`
` PRISCO ..........................................................................................................12
`
` COOPER .........................................................................................................23
`
` WALLACE .....................................................................................................25
`
` TIERNEY ........................................................................................................27
`
` GROUND 1: CLAIMS 23-26 ARE ANTICIPATED BY PRISCO .............................31
`
` GROUND 2: CLAIMS 23-26 WOULD HAVE BEEN OBVIOUS OVER PRISCO IN
`
`VIEW OF COOPER ..................................................................................................80
`
` GROUND 3: CLAIMS 23-26 WOULD HAVE BEEN OBVIOUS OVER PRISCO IN
`
`VIEW OF COOPER AND TIERNEY ............................................................................83
`
` GROUND 4: CLAIMS 25-26 WOULD HAVE BEEN OBVIOUS OVER PRISCO IN
`
`VIEW OF COOPER AND WALLACE, AND, IF NECESSARY, TIERNEY ........................85
`
`ii
`
`2
`
`
`
`I, Bryan Knodel, declare as follows:
`
`1.
`
`I have been engaged as an expert by Fish & Richardson P.C. on behalf
`
`of Intuitive Surgical, Inc. (“Petitioner”) for the above-captioned inter partes review.
`
`I understand that this proceeding involves United States Patent No. 8,479,969
`
`entitled “Drive Interface for Operably Coupling a Manipulatable Surgical Tool to a
`
`Robot” by Frederick E. Shelton IV, filed February 9, 2012 and issued July 9, 2013
`
`(the “’969 Patent” or “’969”). I understand that the ’969 Patent is currently
`
`assigned to Ethicon LLC.
`
`2.
`
`I have reviewed and am familiar with the specification of the ’969
`
`Patent. I will cite to the specification using the following format (’969 Patent, 1:1-
`
`10). This example citation points to the ’969 Patent specification at column 1,
`
`lines 1-10.
`
`3.
`
`I have reviewed and am familiar with the file history of the ’969 Patent
`
`(“FH”). I understand that the file history is being provided as an exhibit in a
`
`single PDF document. I will cite to the PDF pages when I cite to the file history.
`
`4.
`
`I have also reviewed the Petition for Inter Partes Review of the ’969
`
`Patent and am familiar with the following prior art used in the Petition:
`
` IS1006
`
`U.S. Patent No. 8,545,515 to Prisco et al. (“Prisco”)
`
` IS1007
`
`U.S. Patent No. 6,817,974 to Cooper et al. (“Cooper”)
`
` IS1008
`
`U.S. Patent No. 6,699,235 to Wallace et al. (“Wallace”)
`
`1
`
`
`3
`
`
`
`U.S. Patent No. 8,479,969
`
` IS1009
`
`U.S. Patent No. 6,331,181 to Tierney et al. (“Tierney”)
`
` IS1014
`
`U.S. Patent App. No. 2008/0167672 to Giordano et al.
`
`("Giordano")
`
`I have been asked to provide my technical review, analysis, insights and
`
`opinions regarding the ’969 Patent and the above-noted references.
`
`
`
`QUALIFICATIONS
`
`5. My resume is being provided with this Declaration. As indicated there,
`
`I have eight publications and I am a named inventor on over 130 patents for
`
`medical devices. I have extensive experience with surgical instruments, and
`
`surgical staplers in particular, which is the subject matter of the ’969 Patent.
`
`6.
`
`Specifically, I have been involved in the research and development,
`
`design, and manufacture of medical devices including surgical cutting and stapling
`
`devices since 1992, and am qualified to present the analysis provided in this declaration.
`
`7.
`
`I was employed in the Research and Development department as an
`
`engineer of Ethicon Endo-Surgery. I was the lead design engineer for endoscopic
`
`linear staplers/cutters. In this lead design engineer role, it was my responsibility to
`
`understand every aspect of these devices.
`
`8.
`
`One early patent of mine is U.S. Patent No. 5,465,895, entitled
`
`“Surgical Stapler Instruments,” and granted on November 14, 1995. This patent is
`
`referenced in the Background section of the ’969 Patent’s specification as
`
`“disclos[ing] an endocutter with distinct closing and firing actions,” but was not
`
`2
`
`4
`
`
`
`U.S. Patent No. 8,479,969
`
`cited by the Examiner during prosecution. ’969 Patent, 2:13-16. The ’895 Patent
`
`states: “The present invention relates in general to surgical stapler instruments
`
`which are capable of applying lines of staples to tissue while cutting the tissue
`
`between those staple lines and, more particularly, to improvements relating to
`
`stapler instruments and improvements in processes for forming various
`
`components of such stapler instruments.” My ’895 Patent specifically discloses
`
`jaws that open and close and a gear-driven knife to cut stapled tissue. I am thus
`
`generally familiar with such mechanisms for surgical instruments.
`
`9.
`
`Beginning in 1998, I have been a consultant for medical device
`
`companies and law firms. I have consulted in the areas of conceptual design,
`
`prototyping, and turnkey product design.
`
`10.
`
`In addition, I have worked on a variety of surgical products for use in
`
`a wide range of surgical procedures including female reproductive system, female
`
`incontinence, female pelvic floor dysfunction, lung volume reduction, colon,
`
`GERD, bariatrics, CABG, heart valve repair, hernia, general surgical procedures,
`
`and surgical stapling, which is the general subject matter of the patent-at-issue.
`
`11. As part of my consulting practice, I have also acted as a non-testifying
`
`expert in a patent litigation case in the area of medical devices.
`
`12.
`
`I have not testified as an expert witness at trial or by deposition during
`
`the previous four years.
`
`3
`
`5
`
`
`
`U.S. Patent No. 8,479,969
`
`13.
`
`I am being compensated at my usual and customary rate of $200/hour
`
`for my work on this case, plus reimbursement for actual expenses. My
`
`compensation is not contingent upon the conclusions I reach, the outcome of this
`
`inter partes review, or any litigation involving the ’969 Patent.
`
` MY UNDERSTANDING OF CLAIM CONSTRUCTION
`
`14.
`
`I understand that claim terms are read in light of the patent’s
`
`specification and file history as understood by a person of ordinary skill in the art
`
`at the time of the purported invention. I further understand that in an inter partes
`
`review proceeding of an unexpired patent, such as the ’969 Patent, the claim terms
`
`are to be given their broadest reasonable interpretation (“BRI”) consistent with the
`
`specification. I understand that constructions under the BRI standard should be at
`
`least as broad as constructions under the plain and ordinary meaning standard used
`
`in district court litigation.
`
` LEGAL STANDARDS
`
`15.
`
`I am not a lawyer and do not provide any legal opinions. Although I
`
`am not a lawyer, I have been advised that certain legal standards are to be applied by
`
`technical experts in forming opinions regarding meaning and validity of patent
`
`claims.
`
`16. As part of this inquiry, I have been asked to consider the level of
`
`ordinary skill in the field that someone would have had at the time the claimed
`
`4
`
`6
`
`
`
`U.S. Patent No. 8,479,969
`
`invention was made. In deciding the level of ordinary skill, I considered the
`
`following:
`
`
`
`
`
`
`
`the levels of education and experience of persons working in the field;
`
`the types of problems encountered in the field; and
`
`the sophistication of the technology.
`
`17.
`
`I understand that a claim is invalid if a single prior art reference (including
`
`information that the single prior art reference specifically incorporates by reference)
`
`discloses a claimed invention (the invention thus lacks novelty) or if the claim would
`
`have been obvious to one of ordinary skill in the art at the time of the purported
`
`invention based on the teachings of one or more prior art references.
`
`18.
`
`I understand that the time of the purported invention is the earliest
`
`possible effective filing date of the application that discloses the claimed subject
`
`matter. For the ’969 Patent, the filing date is February 9, 2012. The ’969 Patent
`
`claims priority as a continuation of application No. 13/118,259 (the “’259
`
`application”), filed on May 27, 2011, which is a continuation-in-part of application
`
`No. 11/651,807 (the “’807 application”), filed on Jan. 10, 2007 and issued as U.S.
`
`Patent No. 8,459,520 (“the ’520 patent”). I reviewed the ’807 application and saw
`
`no disclosure of a robotic instrument interface to a tool drive assembly having
`
`rotatable body portions, as required by the claims, and therefore I understand that
`
`the ’969 Patent cannot use the ’807 application’s filing date for an effective filing
`
`5
`
`7
`
`
`
`U.S. Patent No. 8,479,969
`
`date. My understanding, therefore, is that the ’969 Patent has a priority date no
`
`earlier than May 27, 2011.
`
`19.
`
`I am informed that a claim can be invalid based on anticipation if each
`
`limitation of the claim is found in the four corners of a single prior art reference
`
`(including any incorporated material), either explicitly or inherently.
`
`20.
`
`I am informed that a claim can be invalid based on obviousness in light
`
`of a single prior art reference alone (based on general knowledge in the art), or
`
`based upon a combination of prior art references, where there is some reason one
`
`of ordinary skill in the art would make the combination.
`
`21.
`
`I am informed that when evaluating whether an invention would have
`
`been obvious, the question is whether 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 to a person of ordinary skill in the art at the time the
`
`purported invention was made. In other words, the question is not whether a single
`
`element “would have been obvious” but whether the claim as a whole would have
`
`been obvious given what was known in the prior art.
`
`22.
`
`I understand that an obviousness analysis should (1) identify the
`
`particular references that, singly or in combination, make the patent obvious; (2)
`
`specifically identify which elements of the patent claim appear in each of the
`
`asserted references; and (3) explain a motivation, teaching, need or market pressure
`
`6
`
`8
`
`
`
`U.S. Patent No. 8,479,969
`
`that would have inspired a person of ordinary skill in the art to combine prior art
`
`references to solve a problem.
`
`23.
`
`I understand that certain objective indicia should be considered, if
`
`available, regarding whether a patent claim would have been obvious or nonobvious.
`
`Such indicia include: commercial success of products covered by the patent claims;
`
`a long-felt need for the invention; failed attempts by others to make the invention;
`
`copying of the invention by others in the field; unexpected results achieved by the
`
`invention as compared to the closest prior art; praise of the invention by the
`
`infringer or others in the field; the taking of licenses under the patent by others;
`
`expressions of surprise by experts and those skilled in the art at the making of the
`
`invention; and the patentee proceeded contrary to the accepted wisdom of the prior
`
`art. I am not aware of any such indicia that would be pertinent to the challenged
`
`claims.
`
`24. Furthermore, I understand that the United Sates Supreme Court in its
`
`KSR vs. Teleflex decision ruled that “if a technique has been used to improve one
`
`device, and a person of ordinary skill in the art would have recognized that it
`
`would improve similar devices in the same way, using the technique is obvious
`
`unless its actual application is beyond that person’s skill.”
`
`7
`
`9
`
`
`
`U.S. Patent No. 8,479,969
`
` LEVEL OF ORDINARY SKILL IN THE ART
`
`25. A person of ordinary skill in the art at the time of the alleged invention
`
`would have had the equivalent of a Bachelor’s degree or higher in mechanical
`
`engineering with at least 3 years working experience in the design of comparable
`
`surgical devices. Additional education in a relevant field, such as mechanical
`
`engineering or robotics (to the extent pertinent), or industry experience may
`
`compensate for a deficit in one of the other aspects of the requirements stated
`
`above.
`
`26.
`
`I am a person of at least ordinary skill in the art, and was such a person as
`
`of the priority date of the ’969 Patent, which I am informed by counsel that, for purposes
`
`of this petition, is May 27, 2011. I was also a person of at least ordinary skill in the
`
`art as of January 10, 2007, the filing date of the grandparent ’520 patent.
`
` OVERVIEW OF THE ’969 PATENT
`
`27. The ’969 Patent’s specification generally has two parts. It first
`
`discusses a hand-held embodiment at length (at roughly columns 11-22), and this
`
`material generally comes from the original application filed in 2007. In 2011, the
`
`applicant filed a “continuation-in-part” application that added new material related
`
`to a robotic embodiment, essentially adapting the handheld surgical instrument to
`
`work with then-existing surgical robot systems, such as those made by Intuitive
`
`Surgical. Each of the claims of the ’969 Patent concern the robotic embodiments
`
`8
`
`10
`
`
`
`U.S. Patent No. 8,479,969
`
`as each requires a “tool mounting portion” to interface with “rotatable body
`
`portions” on a robotic “tool drive assembly.” ’969 Patent at 11:12-42; 23:50-
`
`24:39; accord ’969 Patent, Title. The robotic surgical systems disclosed and
`
`claimed by the ’969 Patent include components that were both typical and
`
`expected of systems in the art at the time of the priority date of the ’969 Patent.
`
`These components include a “master controller” and “robotic arm cart” and a tool
`
`drive assembly with multiple rotary drive members controlling surgical end
`
`effectors. ’969 Patent, 23:50-62; 24:62-25:29; FIGs. 26-27. Each of these
`
`components may be found in the prior art, and in particular the prior art of
`
`Petitioner Intuitive Surgical. Compare ’969 Patent, FIGs. 27 and 29 (“tool drive
`
`assembly”) with Tierney FIGs. 7J and 7E (Driven disks, receiving rotary drive
`
`motions from rotary drive elements on tool drive assembly of robotic surgical
`
`system).
`
` PROSECUTION HISTORY OF THE ’969 PATENT
`
`28. While the application that led to the ’969 Patent was pending, the
`
`Patent Office issued one and only one rejection, over Tierney, directed to two
`
`independent claims. FH at 280-284. The Patent Office also indicated that a
`
`number of dependent claims were allowable, FH at 284, and Applicant amended
`
`the independent claims to include the subject matter identified as allowable. FH at
`
`295-310. However, as discussed below, the subject matter identified as allowable
`
`9
`
`11
`
`
`
`U.S. Patent No. 8,479,969
`
`was well-known to those of skill in the art, as shown in Prisco, Cooper, and
`
`Wallace. The Examiner then issued a notice of allowance, FH at 328-330, and
`
`Patent Owner filed a request for continued examination containing over 2,000 new
`
`references on February 22, 2013. FH at 357-438, 471. A new Notice of
`
`Allowance followed two weeks later on March 7, 2013. FH at 547-552.
`
` THE ’969 PATENT’S PRIORITY DATE
`
`29. As discussed above, the ’969 Patent claims priority as a continuation
`
`of application No. 13/118,259, filed on May 27, 2011, which is a continuation-in-
`
`part of application No. 11/651,807, filed on Jan. 10, 2007 and issued as the ’520
`
`Patent. I have not been asked to consider, and so have not considered, whether the
`
`parent ’259 Application provides written description support for the ’969 Patent.1 I
`
`have, however, considered whether the grandparent ’807 Application that led to the
`
`’520 Patent provides written description support for the challenged claims (nos.
`
`19-26) of the ’969 Patent, and I have concluded that it does not. In particular, each
`
`challenged claim of the ’969 Patent claims a “tool mounting portion” “being
`
`configured to operably interface with the tool drive assembly” and further recites
`
`that the “tool drive assembly” is part of a robotic system. ’969 Patent, 88:13-
`
`
`1 I understand that Intuitive has not conceded that any previously-filed application
`provides written description support for any claim of the ’969 Patent, but merely
`does not challenge the priority claim to the parent ’259 Application for purposes of
`this Petition.
`
`10
`
`12
`
`
`
`U.S. Patent No. 8,479,969
`
`96:60. The claims also recite that the recited instrument has components that
`
`interface with “rotatable body portions” on the robotic tool drive assembly.
`
`30. The grandparent ’807 Application (IS1014) does not disclose, and one
`
`of ordinary skill at the time of the priority date of the ’969 Patent would not have
`
`understood the ’807 Application to disclose, these limitations. Rather, it discusses
`
`– and thus one of ordinary skill in the art would understand it to disclose – only a
`
`“handheld endoscopic surgical instrument” with a mention that the instrument may
`
`be used in “robotic-assisted surgery.” ’807 Application, ¶¶15, 89, FIGs. 1-2.
`
`There is no disclosure in the ’807 Application of the details of any surgical robot
`
`and no mention of the tool drive assembly, the tool mounting portion, or the
`
`rotatable body portions on the tool drive assembly. A person of skill in the art
`
`would not understand the inventors to have possession of the alleged invention of
`
`the challenged claims prior to the filing of the 2011 application.
`
`31. Because the ’807 Application does not disclose the robotic limitations
`
`of the claims, I understand that the ’969 Patent is not entitled to the filing date of
`
`the ’807 Application, and thus the earliest possible filing date the ’969 Patent
`
`would be the date of the ’259 Application, which is May 27, 2011. Again, I offer
`
`no opinion as to whether the parent ’259 Application provides written description
`
`support for any claim of the ’969 Patent, and understand that the burden to show
`
`such a disclosure in an alleged priority document falls on the patentee.
`
`11
`
`13
`
`
`
`U.S. Patent No. 8,479,969
`
` INTERPRETATION OF THE ’969 PATENT CLAIMS AT
`ISSUE
`
`32. As a preliminary matter, I observe that the ’969 Patent uses the terms
`
`“instrument” and “tool” interchangeably. E.g., ’969 Patent, Title, Abstract, 1:54-
`
`65, 2:21-24, 2:50-3:2, 3:6-22, 3:66-4:3, 4:10-20, 10:64-11:42, 24:11-43. The
`
`specification does not describe any difference between these terms, and one of
`
`ordinary skill in the art would understand them to be synonymous at least as used
`
`within the disclosure of the ’969 Patent.
`
`33. Beyond the clarification above, I see no reason that one of ordinary
`
`skill in the art would understand the broadest reasonable interpretation of the terms
`
`of the challenged claims of the ’969 Patent to require clarification beyond the plain
`
`meaning of those terms.
`
` OVERVIEW OF THE ASSERTED PRIOR ART
`
`
`
`Prisco
`
`34. Prisco (U.S. Patent No. 8,545,515 assigned to petitioner, Intuitive
`
`Surgical, Inc.) discloses a surgical robot system of the type described in the ’969
`
`Patent, in which motors in a robotic instrument arm provide rotary power via
`
`interface disks to a removable surgical instrument. Prisco also discloses the details
`
`of removable surgical instruments which have gear-driven selectively movable
`
`portions and which articulate. See, e.g., Prisco, FIGs. 1 through 9 and supporting
`
`text.
`
`12
`
`14
`
`
`
`U.S. Patent No. 8,479,969
`
`35. Prisco describes various embodiments of a surgical tool for use with a
`
`robotic surgical system. Prisco, 6:7-22; 8:4-44. “FIG. 1A is a front elevation view
`
`of the patient side cart component 100 of [Petitioner’s] da Vinci® Surgical
`
`System.” Prisco, 6:14-15.
`
`Instrument
`Arm -
`
`Surgical
`Instrument
`
`Patient Side Cart
`
`
`“FIG. 1A further shows interchangeable surgical instruments 110a, 110b, 110c
`
`mounted on the instrument arms 106a, 106b, 106c . . . .” Prisco, 6:26-28. “FIG.
`
`1B is a front elevation view of a surgeon’s console 120 component of [Petitioner’s]
`
`da Vinci ® Surgical System. The surgeon’s console is equipped with left and right
`
`13
`
`15
`
`
`
`multiple DOF [(degree of freedom)] master tool manipulators (MTMs) 122a, 122b
`
`. . . that are used to control the surgical tools.” Prisco, 6:38-42.
`
`U.S. Patent No. 8,479,969
`
`- Surgeon’s
`Console 120
`
`
`
`36. As shown below in FIG. 2A, each “[instrument] arm [106a, 106b,
`
`106c] is divided into two portions. The first portion is the ‘set-up’ portion 202, in
`
`which unpowered joints couple the links. The second portion is powered, robotic
`
`manipulator portion 204 (patient side manipulator; ‘PSM’) that supports and
`
`moves the surgical instrument.” Prisco, 8:2-6, Fig. 2A.
`
`14
`
`16
`
`
`
`U.S. Patent No. 8,479,969
`
`- Set-Up Portion
`
` - “Patient Side
`Manipulator” (PSM)
`
`
`
`“FIG. 2B [(below)] is a perspective view of the PSM 204 with an illustrative
`
`instrument 110 mounted.” Prisco, 3:4-5, FIG. 2B.
`
`15
`
`17
`
`
`
`U.S. Patent No. 8,479,969
`
`Mounting
`Carriage
`
`Actuators
`
`Surgical
`Instrument
`
`- PSM
`
`Force Transmission Assembly
`
`Shaft
`
`- Wrist
`
`- End Effector
`
`
`
`PSM 204 transmits rotary motion to the removable surgical instrument via “force
`
`transmission disks.” A driving set of force transmission disks is mounted on
`
`“mounting carriage 212” of PSM 204 and a driven set of force transmission disks
`
`is mounted on the “force transmission assembly 230” of the surgical instrument
`
`(which is the “tool mounting portion” of Prisco). Prisco explains:
`
`Matching force transmission disks in mounting carriage
`
`212 and force transmission assembly 230 couple actuation
`
`forces from actuators 232 in PSM 204 to move various
`
`parts of instrument 110 in order to position, orient, and
`
`16
`
`18
`
`
`
`U.S. Patent No. 8,479,969
`
`operate instrument end effector 234. Such actuation forces
`
`may typically roll instrument shaft 218 (thus providing
`
`another DOF [degree of freedom] through the remote
`
`center), operate a wrist 236 that provides yaw and pitch
`
`DOFs, and operate a movable piece or grasping jaws of
`
`various end effectors. . . .
`
`Prisco, 8:34-44.
`
`37. Figure 4A of Prisco provides another view of the mounted surgical
`
`instrument, this time with a flexible shaft for use in a curved cannula. In this
`
`figure, the interface disks 414a “couple actuation forces from servo actuators in
`
`PSM 204a to move instrument 402a components” (e.g., to open and close end
`
`effector 408a):
`
`17
`
`19
`
`
`
`U.S. Patent No. 8,479,969
`
`- Interface Discs
`
`- Force Transmission Mechanism
`
`- Mounting Carriage
`
`PSM -
`
`Instrument -
`
`- Shaft
`
`- Cannula
`
`- End Effector
`
`
`
`Prisco, 10:31-41, FIG. 4A. Prisco explains:
`
`FIG. 4A is a schematic view of a portion of a patient side
`
`robotic manipulator [PSM] that supports and moves a
`
`combination of a curved cannula [416a] and a passively
`
`flexible surgical instrument [402a]. As depicted in FIG.
`
`18
`
`20
`
`
`
`U.S. Patent No. 8,479,969
`
`4A, a telerobotically operated surgical instrument 402a
`
`includes a force transmission mechanism 404a, a passively
`
`flexible shaft 406a, and an end effector 408a. Instrument
`
`402a is mounted on [a mounting carriage] 212a of a PSM
`
`204a (previously described components are schematically
`
`depicted for clarity). Interface discs 414a couple actuation
`
`forces from servo actuators in PSM 204a to move
`
`instrument 402a components.
`
`Prisco, 10:31-41, FIG. 4A.
`
`38. Figures 5 and 6 of Prisco illustrate a surgical instrument with a
`
`flexible shaft in both curved and straight positions, respectively. “FIG. 5 is a
`
`diagrammatic view of an illustrative flexible instrument 500 used with a curved
`
`cannula. Instrument 500 includes a proximal end force transmission mechanism
`
`502, a distal end surgical end effector 504, and a shaft 506 that couples force
`
`transmission mechanism 502 and end effector 504.” Prisco, 12:8-13, FIG. 5.
`
`Shaft -
`
`Force -
`Transmission
`Mechanism
`
`End -
`Effector
`
`
`
`39.
`
`“FIG. 6B is a diagrammatic view that illustrates aspects of a push/pull
`
`19
`
`21
`
`
`
`U.S. Patent No. 8,479,969
`
`[surgical] instrument design. As shown in FIG. 6B, a force transmission
`
`mechanism 620 is coupled to a grip type end effector 622 by a flexible shaft body
`
`624.” Prisco, 14:29-32, FIG. 6B.
`
`Instrument -
`Force Transmission Assembly
`
`- Flexible Shaft Body
`
`- End Effector
`
`
`
`40. Figure 9E provides a close up view of one of Prisco’s end effectors.
`
`In particular, “FIG. 9E is a diagrammatic view that illustrates a push/pull type end
`
`effector that may be at the distal end of the flexible shaft instruments (an
`
`illustrative clip applier end effector is shown).” Prisco, 19, 42-45.
`
`20
`
`22
`
`
`
`U.S. Patent No. 8,479,969
`
`
`
`41.
`
`It is typically necessary to rotate the shaft of a surgical instrument to
`
`reposition the end effector. Like the ’969 Patent, Prisco uses a tube gear to rotate
`
`the shaft. Prisco specifically discloses that the shaft is rotated by a “helical drive
`
`gear” that drives a tube gear called the “shaft roll gear,” as shown in FIG. 7C:
`
`21
`
`23
`
`
`
`U.S. Patent No. 8,479,969
`
`
`
`Prisco, FIG. 7C; 15:36-16:7.
`
`42. Prisco also discloses articulation of the end effector via a “wrist” of
`
`the surgical instrument. For the wrist mechanism, Prisco incorporates Cooper,
`
`which is another surgical robotic reference: “A wrist to provide one or more end
`
`effector DOF’s [Degrees of Freedom] (e.g., pitch, yaw; see e.g., U.S. Pat. No.
`
`6,817,974 (filed Jun. 28, 2002) (disclosing “Surgical Tool Having Positively
`
`Positionable Tendon-Actuated Multi-Disk Wrist Joint”), which is incorporated
`
`herein by reference) is optional and is not shown.” Prisco, 10:43-48. One of
`
`ordinary skill in the art would have understood that Prisco is pointing to Cooper for
`
`additional details about the wrist mechanism of Prisco, and, would have
`
`understood that Cooper was being incorporated into Prisco as if it were set out
`
`22
`
`24
`
`
`
`U.S. Patent No. 8,479,969
`
`expressly rather than through incorporation.
`
`43. Finally, Prisco discloses gear-driven actuation of the end effector. For
`
`example, Prisco discloses a “rack gear 784” that operates the grasping jaws of
`
`various end effectors. Pinion drive gears 782 cause rack gear 784 to move back
`
`and forth along the shaft’s longitudinal axis, thus pushing and pulling a drive rod
`
`that runs through the shaft and is coupled to the end effector jaws. Prisco, 16:13-
`
`23; FIG. 7D.
`
`Rack Gear
`
`Pinion Drive
`Gears
`
`
`
` Cooper
`
`44. As noted above, Prisco incorporates by reference at least the wrist
`
`mechanism disclosed in Cooper (U.S. Patent No. 6,817,974 also assigned to
`
`petitioner, Intuitive Surgical, Inc.). Much like Prisco, Cooper discloses “a surgical
`
`instrument 400 having an elongate shaft” configured to releasably couple “a
`
`robotic arm or system.” Cooper, 17:26-50. As shown in FIG. 36, the instrument
`
`23
`
`25
`
`
`
`U.S. Patent No. 8,479,969
`
`400 includes an end effector 406 and a base 410, which couples the instrument to a
`
`robotic system. A shaft connects the end effector to the base and the shaft rotates
`
`in either direction to rotate the end effector, “as indicated by arrows H:”
`
`
`
`Cooper, FIG. 36; 17:35-50; see also FIG. 64; 24:1-23.
`
`45. Furthermore, Cooper’s surgical instrument includes an articulation
`
`system comprising a proximal disk 412 and a distal disk 416 coupled via grip
`
`support 420 to an end effector 406. As shown in FIG 37, there are several pivot
`
`points between the proximal disk 412 and the distal disk 416 that supports end
`
`effector 406. Together these form an articulation joint (i.e., a wrist):
`
`24
`
`26
`
`
`
`U.S. Patent No. 8,479,969
`
`Pivot Point
`
`Pivot Point
`
`Pivot Point
`
`Pivot Point
`
`
`
`Cooper, 5:54-6:3; 13:22-49, 17:25-64; FIGs. 14-21, 36-39, 51-56; see also 14:14-
`
`59 (“hinge mechanisms disposed on opposite sides of the disks guide the disks in
`
`pitch and yaw rotations to produce, for instance, the 90° pitch of the wrist 140”);
`
`21:49-22:41, FIGS. 17-21 (disclosing another embodiment having proximal and
`
`distal disks).
`
` Wallace
`
`46. The Wallace reference (U.S. Patent No. 6,699,235 also assigned to
`
`petitioner, Intuitive Surgical, Inc.) teaches “a robotic surgical tool for use in a
`
`robotic surgical system” that, similar to the instruments of Prisco, includes a shaft
`
`25
`
`27
`
`
`
`U.S. Patent No. 8,479,969
`
`supporting a surgical end effector with a “tool base 62 [that] includes an interface
`
`64 which mechanically and electrically couples the tool 50 to a manipulator on the
`
`robotic arm cart.” Wallace, FIGs. 1, 2A; Abstract; 7:33-56:
`
`Wrist
`Joint
`
`
`
`
`
`Wallace, FIGs. 1, 2A; Abstract; 7:33-56.
`
`47. Wallace further discloses an articulation assembly comprising “wrist
`
`joint or mechanism” that is actuated by “a plurality of rods” that are driven by a
`
`gear assembly including “sector gears 312” and “gears 400” to advance and retract
`
`rods to cause articulation of the articulation wrist joint. Wallace, 7:57-65; 13:6-
`
`26
`
`28
`
`
`
`14:15, Fig. 30.
`
`U.S. Patent No. 8,479,969
`
`Wrist Articulation
`Gear Assembly
`
` Tierney
`
`Articulation Rods
`
`
`
`48. U.S. Patent No. 6,331,181 to Tierney et al. (“Tierney”) and also
`
`assigned to petitioner, Intuitive Surgical, Inc., is incorporated by reference into
`
`Prisco. Specifically, Prisco describes that information stored in its surgical
`
`instrument may be “accessed by the robotic surgical system during operation to
`
`properly use the instrument (see e.g., U.S. Pat. No. 6,331,181 (filed Oct. 15, 1999)
`
`(disclosing surgical robotic tools, data architecture, and use), which is incorporated
`
`herein by reference).” Prisco, 15:17-20. One of ordinary skill in the art would
`
`have understood that Prisco is pointing to Tierney for additional details about the
`
`surgical robotic system of Prisco, and, would have understood that Tierney was
`
`being incorporated broadly and unequivocally in its entirety—for its entire
`
`disclosure of “robot tools, data architectures, and use,” and indeed the title of
`
`27
`
`29
`
`
`
`U.S. Patent No. 8,479,969
`
`Tierney is “Surgical Robotic Tools, Data Architecture, and Use.”
`
`49.
`
`In FIG. 4A and 6, Tierney discloses “driven elements 118” with pairs
`
`of pins 122 that “provide mechanical coupling of the end effector to drive motors
`
`mounted to the manipulator [robot arm].” Tierney, 10:12-15. Tierney further
`
`discloses, in e.g., FIGs. 7A-7H, an adapter that connects the driven elements to the
`
`tool holder on the robot arm. The driven elements 118 would mechanically couple
`
`to the rotatable bodies 134 on the adapter, which are in turn driven by the rotary
`
`drive elements on the tool holder. One of ordinary skill in the art would have
`
`understood that the rotatable bodies 134 on the adapter of Tierney correspond to
`
`the force transmission disks of Prisco and that the tool holder 129 and adapter 128
`
`of Tierney corresponds to the mounting carriage 212 of Prisco. Indeed, the
`
`descriptions and images of this structure in both patents are nearly identical. One
`
`of ordinary skill in the art would further have understood that the drive elements on
`
`the tool holder impart rotary motion to the rotatable bodies 134 on the adapter,
`
`which in turn provides rotary motion to the driven disks on the tool itself. Thus, it
`
`would have been clear to one of ordinary skill in the art that Prisco’s “interface
`
`disks” on the instrument (and specifically in the force transmission mechanism)
`
`receive rotary motion from their matching disks on the robot arm.
`
`50. One of ordinary skill in the art would have recognized that the robotic
`
`system disclosed in the ’969 Patent is very similar to the robotic system disclosed
`
`28
`
`30
`
`
`
`U.S. Patent No. 8,479,969
`
`in the prior art Tierney reference. The following comparisons of corresponding
`
`figures illustrates the similarity between the ’969 Patent’s surgical robot and the
`
`surgical robot of Tierney:
`
`’969 patent
`
`Tierney Prior Art
`
`Robotic Controller
`
`
`
`Robotic Manipulator
`
`
`
`
`
`
`
`2