UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`MAKO SURGICAL CORP.,
`Petitioner
`
`v.
`
`BLUE BELT TECHNOLOGIES, INC.,
`Patent Owner
`
`_____________________
`
`IPR2015-00629
`U.S. Patent No. 6,757,582 B2
`_____________________
`
`
`PATENT OWNER RESPONSE
`
`
`
`
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`
`

`
`TABLE OF CONTENTS
`
`I.
`
`III.
`
`1.
`2.
`
`Page
`Introduction .................................................................................................. 1
`A. Statement Of Relief Requested .................................................................... 2
`B. Overview Of United States Patent No. 6,757,582 ....................................... 2
`C. Level Of Ordinary Skill In The Art .............................................................. 5
`D. Claim Construction ....................................................................................... 6
`E. Summary Of Patent Owner’s Argument ...................................................... 9
`Context Of Inventive Disclosure Of References Relied Upon By
`II.
`Petitioner .................................................................................................................. 10
`A. Taylor ......................................................................................................... 10
`B. Glassman .................................................................................................... 12
`C. Delp ............................................................................................................ 13
`D. DiGioia ....................................................................................................... 14
`Patent Owner’s Response To Instituted Grounds Of Unpatentability ....... 14
`A. The Claims Of The ‘582 Patent Instituted For Review Are Not
`Anticipated By Taylor ................................................................................ 14
`Independent Claim 1 .................................................................................. 15
`Instituted Claims Depending From Claim 1 Of The ‘582 Patent Are
`also Not Anticipated By Taylor ................................................................. 23
`Independent Claim 17 ................................................................................ 28
`Instituted Claims Depending From Claim 17 Of The ‘582 Patent
`Are also Not Anticipated By Taylor .......................................................... 31
`Independent Claim 24 ................................................................................ 36
`Instituted Claims Depending From Claim 24 Of The ‘582 Patent
`Are also Not Anticipated By Taylor .......................................................... 40
`B. The Claims Of The ‘582 Patent Instituted For Review Are Not
`Obvious Over Taylor As A Single Reference, Or In View Of
`Glassman, Delp, Or DiGioia ...................................................................... 51
`1. Claim 3 Is Not Obvious Over Taylor In View Of Glassman ..................... 52
`2. Claim 7 Is Not Obvious Over Taylor In View Of DiGioia ........................ 54
`3. Claim 11 Is Not Obvious Over Taylor ....................................................... 56
`4. Claims 48 And 49 Are Not Obvious Over Taylor In View Of Delp ......... 58
`Conclusion .................................................................................................. 60
`IV.
`Exhibit List for Patent Owner’s Response to Inter Partes Review of
`V.
`U.S. Pat. No. 6,757,582 ........................................................................................... 61
`
`3.
`4.
`
`5.
`6.
`
`
`
`i
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`

`
`TABLE OF AUTHORITIES
`
`Cases
`
`Page(s)
`
`In re NTP, Inc.,
`654 F.3d 1279 (Fed. Cir. 2011) .......................................................................... 53
`KSR Int'l Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) ............................................................................................ 52
`SRI Int’l, Inc. v. Internet Sec. Sys.,
`511 F.3d 1186 (Fed. Cir. 2008) .......................................................................... 14
`Trindec Indus., Inc. v. Top-USA Corp.,
`295 F.3d 1292 (Fed. Cir. 2002) .......................................................................... 14
`
`Statutes
`35 U.S.C. § 102(b) .............................................................................................. 1, 14
`35 U.S.C. § 103(a) .................................................................................... 1, 2, 53, 54
`35 U.S.C. § 112 .......................................................................................................... 7
`35 U.S.C. § 316 .......................................................................................................... 2
`35 U.S.C. § 316(e) ........................................................................................ 2, 15, 54
`Inter Partes Review,
`35 U.S.C. §§ 311-319 ........................................................................................... 1
`
`Regulations
`37 C.F.R. § 42.100(b) ................................................................................................ 7
`37 C.F.R. § 42.120 ..................................................................................................... 1
`
`
`
`ii
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`

`
`
`
`I.
`
`Introduction
`
`Patent Owner Blue Belt Technologies, Inc. (hereinafter, “Patent Owner”)
`
`respectfully submits this Patent Owner Response under 35 U.S.C. §§311-319 and
`
`37 C.F.R. §42.120. It is being timely filed by November 10, 2015 pursuant to the
`
`parties’ stipulation on due dates filed as Paper No. 9 on October 8, 2015.
`
`The Patent Trial and Appeal Board (hereinafter the “Board” or “PTAB”)
`
`instituted review on the following grounds: (1) claims 1, 5, 6, 8, 9, 13, 14, 16, 17,
`
`21-30, 34-42, 47, and 50-58 of U.S. Patent No. 6,757,582 (hereinafter, Ex. 1001 or
`
`the “’582 Patent”) being anticipated under 35 U.S.C. §102(b) over Taylor (Ex.
`
`1008), (2) claim 3 of the ’582 Patent being obvious under §103(a) over Taylor in
`
`view of Glassman (Ex. 1009), (3) claims 48-49 of the ’582 Patent being obvious
`
`under §103(a) over Taylor in view of Delp (Ex. 1011), (4) claim 7 of the ’582
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`Patent being obvious under §103(a) over Taylor in view of DiGioia (Ex. 1010),
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`and (5) claim 11 of the ’582 Patent being obvious under §103(a) over Taylor as a
`
`single reference. Institution Decision at 19.
`
`“In an inter partes review instituted under this chapter, the petitioner shall
`
`have the burden of proving a proposition of unpatentability by a preponderance of
`
`the evidence.” 35 U.S.C. §316(e). Petitioner’s proposition of unpatentability fails
`
`to meet that burden with respect to any of the claims of the ’582 Patent instituted
`
`for review by the Board.
`
`1
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`
`

`
`A.
`
`Statement Of Relief Requested
`
`
`
`Pursuant to 35 U.S.C. §316, Patent Owner respectfully requests that the
`
`Board find that Claims 1, 3, 5, 6-9, 11, 13, 14, 16, 17, 21-30, 34-42, and 47-58 (the
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`“Instituted ’582 Patent Claims”) are patentable in view of the instituted grounds of
`
`unpatentability under consideration by the Board.
`
`B. Overview Of United States Patent No. 6,757,582
`
`The USPTO issued the ’582 Patent, entitled “Methods And Systems To
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`Control A Shaping Tool,” on June 29, 2004. The ’582 Patent generally relates to
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`systems and methods for providing 3-D and 4-D imaging of a workpiece and a
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`shaping tool, using tracking data to determine a relationship between the
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`workpiece and shaping tool, and controlling the shaping tool based on such
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`relationship. Practice of these claims can occur in a variety of applications in the
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`medical field, for example, where surgical systems and robotic surgical systems
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`may be used for high-precision bone repair and joint replacement operations.
`
`The ’582 Patent discloses novel systems and methods for controlling a
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`shaping or cutting tool used to shape a workpiece (such as a bone), including the
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`use of manual or robotic cutting tools used in the medical field for orthopedic
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`surgical procedures. Ex. 1001 at 1:13-50. Prior systems suffered from numerous
`
`drawbacks, including for example, the necessity to fix the target bone in place
`
`using screws or clamps in order to achieve precise cutting. Bone fixation
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`
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`2
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`

`
`
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`introduced risks to the patient such as pain, infection, and longer recovery and
`
`rehabilitation periods. Id. Both detectable and undetectable failures in prior
`
`systems led to unintended cuts or actions to the patient, resulting in failed
`
`procedures and even serious injuries. Id. Among the goals of the ’582 Patent
`
`inventors was to address these drawbacks of the prior art systems. Id. at 1:28-37,
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`1:44-50.
`
`The specification of the ’582 Patent describes multiple embodiments,
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`including those in which a user controls a cutting tool manually, where a
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`combination of manual and robotic control is used, and where a robot is
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`programmed to cut a predetermined shape. Id. at 14:49-55. In all embodiments,
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`the specification explains that an improvement over the prior art is the use of
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`image-based tracking data provided for both the workpiece and the cutting tool,
`
`which is used to provide a number of different controls to the cutting tool that
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`minimize or eliminate the potential for injury or damage. Id. at 1:64-2:2. In some
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`embodiments, the improvement is achieved by continuously tracking the location
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`of both the cutting tool and the workpiece during a procedure, so that the spatial
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`relationship between the two objects is monitored and the cutting tool can be
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`retracted, stopped, or otherwise controlled if it approaches the wrong location.
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`According to the ’582 Patent, tracking may be accomplished by, among
`
`other ways, associating or affixing markers to both the workpiece and the cutting
`
`
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`3
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`

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`
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`tool, using sensors to track both objects via registration to a coordinate system,
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`and determining the relationship between the locations of both objects. Id. at 9:5-
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`35. Using the data generated from tracking both objects, updated images may be
`
`continuously produced, and the system is able to “compute and transmit a control
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`signal to the cutting tool, where the control signal can be a signal to stop, retract,
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`continue, or reduce speed,” if the cutting tool approaches an undesired location.
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`Id. at 9:36-45.
`
`Figure 7 of the ’582 Patent (reproduced below) depicts an exemplary
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`embodiment with a hand-held tool (30) with a cutting element (34) and marker
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`(36), a controller (50) connected to a tracker (20), and a workpiece (40) with an
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`example of one type of marker (46) associated with it.
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`
`
`
`
`4
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`

`
`
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`The ’582 Patent also describes providing 4-D images of both the workpiece
`
`and the cutting tool. Such 4-D images, which are 3-D images updated over time,
`
`allow the system of the ’582 Patent to control the cutting tool based on the
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`relationship between the imaging data for the workpiece and for the cutting tool,
`
`and enable visualization tools for the user. For example, ’582 Patent discloses the
`
`use of “voxels,” which are 3-D volume pixels, for representing the 3-D images of
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`the workpiece. Functions performed on the voxels provide improved visualization
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`tools, such as applying classification schemes to “label” or distinguish between the
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`portions of workpiece that are to be removed during a procedure, and the portions
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`of the workpiece that are to comprise the target shape desired as a result of the
`
`procedure. Such classifications can also be based on the relationship between the
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`location of the workpiece and the location of the cutting tool, as provided by the
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`tracking data, enabling a user to visualize the goal and progress of a procedure in
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`three dimensions over time. E.g., Ex. 1001 at 2:3-38.
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`C. Level Of Ordinary Skill In The Art
`
`A person of ordinary skill in the art, at the time the patent was filed, would
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`have a Master’s or Doctorate degree with a concentration in mechanical or medical
`
`engineering (or an equivalent thereof) from an accredited engineering program,
`
`with an area of emphasis related to image-guided devices or medical robotics, and
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`around two years of relevant experience in the industry. The characteristics of a
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`
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`5
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`

`
`
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`person of ordinary skill in the field of art of the ’582 Patent would include a
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`working knowledge of image-guided medical devices and surgical robot design.
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`Someone with less technical education but more practical experience, or more
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`technical education but less practical experience, could also be considered a person
`
`of ordinary skill in the art. See Ex. 2004 at ¶¶13-17.
`
`D. Claim Construction
`
`A claim subject to an inter partes review “shall be given its broadest
`
`reasonable construction in light of the specification.” 37 CFR 42.100(b). With
`
`respect to the Instituted ’582 Patent Claims, Petitioner has proposed constructions
`
`for the following claim terms: “means to provide at least one image” (Claim 11),
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`“the tuning tool image” (Claim 24), and “4-D image” (Claim 24). Petition at 9-12.
`
`In response, the Board has construed the means to provide at least one image in
`
`claim 11 as “a CAD, CT, MRI, X-Ray, fluoroscopy and/or ultrasound, and
`
`equivalent structures.” Institution Decision at 6. The Board has also construed the
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`tuning tool image recited in claim 24 as a “cutting tool image,” as a result of an
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`obvious error by the USPTO. Id. at 8. The Board declined to construe the term
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`“4-D image” recited in claim 24 (id. at 9), hence giving the term its broadest
`
`
`
`6
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`
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`reasonable construction, at least including updating a 3-D image over time as
`
`argued by Patent Owner in the related district court case.1
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`In addition, Petitioner has applied an overly broad meaning of the term
`
`“tracking data associated with the workpiece” recited in Claim 1, and the phrase
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`“track the cutting tool and the workpiece” in Claim 17. Ex. 1001 at 20:47, 21:45-
`
`46. The broadest reasonable interpretation of “tracking data associated with the
`
`workpiece” can be understood from the context of Claim 1 and the specification.
`
`Claim 1 recites a tracker that “includes at least one of: at least one first marker
`
`associated with the workpiece, and at least one second marker associated with the
`
`cutting tool.” Id. at 20:42-44. The “controller” clause in Claim 1 then refers to
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`“the tracking data associated with the cutting tool and the tracking data associated
`
`
` 1 Petitioner contends that Claims 10-12 and 18 recite means-plus-function
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`limitations under 35 U.S.C. § 112, ¶6. Petition at 9-10. The Board agreed in
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`part, and declined to interpret claims 10-12 and 18, finding them to be means-
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`plus-function claims lacking “corresponding algorithms as required for
`
`computer-implemented functions.” Institution Decision at 8. Patent Owner
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`notes for the record that it does not agree with Petitioner or the Board that
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`Claims 10-12 and 18 recite means-plus-function limitations lacking
`
`corresponding algorithms.
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`
`
`7
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`

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`
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`with the workpiece.” Id. at 20:46-47. Thus, read together, the claim requires some
`
`mechanism for generating tracking data for both the workpiece and the cutting
`
`tool. From the specification, tracking data can be understood to include at least
`
`one position and at least one angle relative to a coordinate system. See, e.g., Ex.
`
`1001 at 2:45-52 (“The tracker can measure and/or determine at least one position
`
`and at least one angle associated with the workpiece and/or the cutting tool, where
`
`in one embodiment, the tracker can track in three positions and three angles to
`
`provide six degrees of freedom.”); 4:62-5:16 (describing data providing a
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`relationship in terms of angles and position); 9:46-61 (describing tracking data
`
`providing values in three or four dimensions). Thus, the broadest reasonable
`
`interpretation of “tracking data associated with the workpiece” in the context of the
`
`’582 Patent claims and specification should be “data that identifies a position of an
`
`object over time within a coordinate system.” See Ex. 2004 at ¶¶33-34.
`
`Similarly, for Claim 17, the PTAB should find that the broadest reasonable
`
`interpretation of the term “track the cutting tool and the workpiece” (Ex. 1001 at
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`21:45-46) is “identify a position of the cutting tool and of the workpiece over time
`
`within a coordinate system.” Again, Claim 17 recites a tracker that tracks “at least
`
`one of: a cutting tool and the workpiece,” and then recites that the control system
`
`includes a processor to “track the cutting tool and the workpiece.” Id. So, Claim
`
`17 explicitly requires tracking both the cutting tool and the workpiece. Claim 17
`
`
`
`8
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`

`
`
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`further recites “associat[ing] the tracked data to an image,” so the processor
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`“track[s] the cutting tool and the workpiece” to generate tracked data and then
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`“associate[s] the tracked data to an image.” The “tracked data” referenced in
`
`Claim 17, similar to the “tracking data” discussed in reference to Claim 1, provides
`
`a position and angle within a coordinate system for the system to associate with an
`
`image. Therefore, the broadest reasonable interpretation of “track the cutting tool
`
`and the workpiece” is “identify a position of the cutting tool and of the workpiece
`
`over time within a coordinate system.” See Ex. 2004 at ¶35.
`
`E.
`
`Summary Of Patent Owner’s Argument
`
`Petitioner’s arguments for unpatentability fail for multiple reasons. First,
`
`Petitioner fails to establish that any of the instituted claims are anticipated by
`
`Taylor, including Claims 1, 5, 6, 8, 9, 13, 14, 16, 17, 21-30, 34-42, 47, and 50-58.
`
`As detailed below in Section III.A., the elements missing from Taylor include
`
`tracking the workpiece (Claim 1), a control system including instructions to cause
`
`a processor to track the workpiece (Claim 17), and the use of 4D images (Claim
`
`24). For at least the same reasons, Taylor fails to disclose each and every element
`
`of the instituted claims that depend from independent Claims 1, 17, and 24.
`
`Second, Petitioner also fails to establish that any of Claims 3, 7, 11, 48, or
`
`49 are rendered obvious by Taylor as a single reference, or in combination with
`
`Glassman, Delp, or DiGioia. As detailed below in Section III.B., the combination
`
`
`
`9
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`

`
`
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`references fail to remedy the disclosures missing from Taylor, and therefore the
`
`combination also fails to disclose each and every element of these claims.
`
`Petitioner further fails to establish obviousness over Taylor in view of either Delp
`
`or DiGioia, because a person of ordinary skill in the art would not have been
`
`motivated to combine either of Delp or DiGioia with Taylor.
`
`II.
`
`Context Of Inventive Disclosure Of References Relied Upon By
`Petitioner
`A. Taylor
`
`Taylor describes a system that focuses on one fundamental principal: the
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`workpiece must be fixed throughout the operation so that it cannot move. Taylor
`
`describes operation on a femur and clearly emphasizes the need for the femur to be
`
`fixed in place throughout the operative process so that the correct portion of the
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`femur is actually cut. See Ex. 2004 at ¶40.
`
`Taylor discloses an “image-directed robotic system to augment the
`
`performance of human surgeons in precise bone machining procedures in
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`orthopaedic surgery.” Ex. 1008 at Abstract. In Taylor’s system, the surgeon must
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`first implant titanium into the patient’s femur. Id. at 262. “A CT scan is made of
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`the leg. The presurgical planning system automatically locates the pins relative to
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`the coordinate system of the CT images. The surgeon interactively selects an
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`implant model and determines its desired placement relative to CT coordinates.
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`This information is written to a diskette for use during surgery.” Id. at 262-63.
`
`
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`10
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`

`
`
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`Next, a robot is brought into the operating room and loaded with the diskette that
`
`contains the information that was written into it for use during surgery. Before any
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`cutting takes place on the femur, “the femur is rigidly attached to the robot base,
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`using a specially designed fixator. The three titanium pins are exposed manually.”
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`Id. at 263.
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`“The robot controller uses the pin location information to compute an
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`appropriate transformation from CT coordinates to robot coordinates . . . the robot
`
`cuts out the desired implant shape at the planned position and orientation relative
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`to the pins . . . When cutting is complete, the femur is unclamped from the fixator .
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`. . .” Id. Again, Taylor emphasizes that the femur is fixed during the entire
`
`procedure, with the clamps removed only after cutting is done. Thus, Taylor is
`
`directed to the automatic milling of a workpiece based on a pre-operative plan,
`
`requiring fixation of the workpiece relative to the robot. See, e.g., Mako’s Prelim.
`
`Resp. in IPR2015-00765 at 29, 44; see also Ex. 2004 at ¶40. Taylor’s system
`
`therefore includes one of the primary drawbacks addressed by the ’582 Patent
`
`inventors, the need for bone fixation and the possibility of detected or undetected
`
`failures with the cutting tool. Ex. 1001 at 1:28-50; see Ex. 2004 at ¶40.
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`The ’582 inventors sought to overcome the need for bone fixation and
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`reduce the possibility of errant cutting by disclosing a system that maintained the
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`spatial relationship between the shaping tool and the workpiece using an image-
`
`
`
`11
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`

`
`
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`guided system that tracks both the workpiece and the shaping tool. Id. at 1:53-2:2;
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`see Ex. 2004 at ¶40. Taylor, on the other hand, relies on bone fixation rather than
`
`tracking the workpiece, and specifically warns against using the kind of image-
`
`based tracking from the ’582 Patent, explaining that “it is often awkward to
`
`maintain a clear field of view required for optical checking equipment.” Ex. 1008,
`
`at 273; see Ex. 2004 at ¶40. Taylor even indicated that the additional “operating-
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`room complexity involved” with an image-based system was not justified when the
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`robot system is already being checked, such as through encoders. Ex. 1008 at 273.
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`The ’582 Patent improves on the prior art at least by providing a system which can
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`use these previously-discouraged image-based tracking systems. See Ex. 2004 at
`
`¶40.
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`Finally, while Taylor also discloses an “intraoperative display” for “showing
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`the progress of the cutting phase of the surgery” (Ex. 1008 at 269), at most this
`
`display provides “orthogonal cross-sections” of the 3-D CT data for the workpiece
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`only (which in Taylor’s particular application is a bone). Id. There is no image-
`
`based representation of the surgical tool itself on the intraoperative display, and the
`
`images of the workpiece are only two-dimensional cross-sections taken from the
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`pre-operative 3-D data. See id. at 267; see also Ex. 2004 at ¶¶64, 72.
`
`B. Glassman
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`
`
`12
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`

`
`
`
`Glassman is a patent directed to an “Imaged-Directed Robotic System For
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`Precise Robotic Surgery Including Redundant Consistency Checking.” Ex. 1009 at
`
`Abstract. Glassman provides for an automatic, robotic surgery system that is very
`
`similar to the system of Taylor, who is also a named inventor on the patent. See
`
`Ex. 2004 at ¶¶96-101. At most, the Glassman system uses an “optical tracking
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`system . . . coupled to the robot end effector.” Ex. 1009, at 4:11-17 (emphasis
`
`added); see Ex. 2004 at ¶¶96-101. As such, the system of Glassman also only
`
`tracks the robotic cutting tool, and like Taylor, relies on bone fixation for
`
`maintaining the position of the workpiece. See, e.g. id. at 2:36-38 (discussing the
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`use of a “strain gage for detecting . . . any slippage between an immobilized tissue,
`
`such as bone, and a reference point”); see also Ex. 2004 at ¶¶96-101.
`
`C. Delp
`
`Delp relates to “An Interactive Graphics-Based Model of the Lower
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`Extremity to Study Orthopaedic Surgical Procedures.” Ex. 1011 at 757. As
`
`implied by the title, Delp does not disclose an imaging-based system for tracking a
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`workpiece and a shaping tool, but a system that provides “graphics-based”
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`representations, or models, that represents anatomy as, for example, “wireframe
`
`objects.” Id. at 758; see also Ex. 2004 at ¶¶102-06. Delp is aimed to medical
`
`researchers studying “simulated surgeries” and “tools for designing and analyzing
`
`surgical procedures.” Ex. 1011 at Abstract; Ex. 2004 at ¶¶102-06.
`
`
`
`13
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`

`
`D. DiGioia
`
`
`
`DiGioia is a patent directed to a “Computer-Assisted Surgery Planner And
`
`Intra-Operative Guidance System.” Ex. 1010. DiGioia provides for “facilitating
`
`the implantation of an artificial component” in a joint. Id. at Abstract; see also Ex.
`
`2004 at ¶¶107-12. DiGioia uses “an optical tracking system” and “a number of
`
`special light emitting diodes” affixed to “bones, tools, and other objects in the
`
`operating room equipment.” Ex. 1010 at 6:35-43.
`
`III.
`
`Patent Owner’s Response To Instituted Grounds Of Unpatentability
`
`A. The Claims Of The ‘582 Patent Instituted For Review Are Not
`Anticipated By Taylor
`
`The Board instituted review of claims 1, 5, 6, 8, 9, 13, 14, 16, 17, 21-30, 34-
`
`42, 47, and 50-58 of the ’582 Patent on grounds that they are anticipated by
`
`“Taylor” under 35 U.S.C. §102(b). Institution Decision at 19. A patent claim is
`
`anticipated only if “each and every element as set forth in the claim is found, either
`
`explicitly or inherently described, in a single prior art reference.” SRI Int’l, Inc. v.
`
`Internet Sec. Sys., 511 F.3d 1186, 1192 (Fed. Cir. 2008) (quoting Verdegaal Bros.,
`
`Inc. v. Union Oil Co., 814 F.2d 628, 631 (Fed. Cir. 1987)). “Inherent anticipation
`
`requires that the missing descriptive material is ‘necessarily present,’ not merely
`
`probably or possibly present” in the anticipating reference. Trindec Indus., Inc. v.
`
`Top-USA Corp., 295 F.3d 1292, 1295 (Fed. Cir. 2002) (quoting In re Robertson,
`
`169 F.3d 743, 745 (Fed. Cir. 1999)). In an inter partes review, the Petitioner bears
`
`
`
`14
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`

`
`
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`“the burden of proving a proposition of unpatentability by a preponderance of the
`
`evidence.” 35 U.S.C. §316(e). Petitioner has not met this burden with respect to at
`
`least the following limitations of the challenged claims of the ’582 Patent.
`
`1. Independent Claim 1
`a. Tracking Data Associated With The Workpiece
` Independent Claim 1 recites, “a controller to control the cutting tool based
`
`on the tracking data associated with the cutting tool and the tracking data
`
`associated with the workpiece.” Ex. 1001 at 20:45-47. For the reasons discussed
`
`above in the claim construction section and the additional reasons provided below,
`
`Claim 1 requires tracking data that identifies the position of the workpiece over
`
`time within a coordinate system. Further, Claim 1 recites, “a tracker to provide
`
`tracking data associated with the cutting tool and the workpiece, where the tracker
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`includes at least one of: at least one first marker associated with the workpiece . . .”
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`Ex. 1001 at 20:40-43. Thus, the reference to tracking data in the controller element
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`refers back to tracking data provided by a tracker that can include a first marker
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`associated with the workpiece. In other words, tracking data associated with the
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`workpiece is derived from a first marker associated with the workpiece. The
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`specification explains, for example, that a “marker can be affixable to a workpiece
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`that includes a target shape . . . [and] [a] tracker can . . . also track a position of the
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`workpiece based on a position of the . . . marker” (Ex. 1001 at 5:26-30), which is
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`also depicted as marker 46 in Figure 7. The first marker associated with the
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`workpiece can be, for example, a source for infrared, Radio Frequency (RF),
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`ultrasound, or other transmitted information that is used by the tracker to track the
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`location of the workpiece. Ex. 1001 at 3:60-67. Crucially, the marker associated
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`with the workpiece is monitored (i.e., tracked) by the tracker, which in turn feeds
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`tracking data to the controller of Claim 1 (using a wired or wireless connection) so
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`that the location of the marker, and therefore the location of the workpiece with
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`which it is associated, can be tracked continuously as the system is used. Ex. 1001
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`at 17:12-29.
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`Thus, this language requires that the system of Claim 1 provide tracking data
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`associated with the workpiece to the controller, which is derived from a first
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`marker associated with the workpiece. In fact, the ’582 Patent inventors explained
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`in the background section of the specification that a crucial drawback to prior art
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`systems was that their reliance on bone fixation meant such systems “cannot or do
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`not track the target.” Ex. 1001 at 1:30-35 (emphasis added). Accordingly, when
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`viewed in light of the ‘582 Patent specification, one of ordinary skill in the art
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`would understand that to provide the recited “tracking data associated with the
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`workpiece” the system logically needs to include “a first marker associated with
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`the workpiece,” as the ‘582 Patent discusses no other mechanism for obtaining
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`tracking data.
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`Taylor explicitly discloses the exact disadvantageous system discussed by
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`the’582 Patent inventors, which is based on bone fixation: “A sterile fixator rigidly
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`attached to the robot’s base holds the bone during the robotic part of the
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`procedure.” Ex. 1008 at 265 (emphasis in original). The system in Taylor uses
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`“strain gauges that can detect possible shifts of the bone relative to the fixation
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`device” (id.), but these gauges were not capable of generating any “tracking data
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`associated with the workpiece,” because if a shift was detected, the robot controller
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`was simply directed to stop moving. Id. Instead, the gauges merely sense whether
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`a movement had occurred, but cannot distinguish between a situation in which the
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`bone moved in one direction and stayed there, and a situation in which the bone
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`tripped the gauge by momentarily moving and then moving back to its original
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`location. In any case, Taylor does not disclose that the strain gauges were capable
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`of providing data about the actual location of the bone at any given time. See Ex.
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`2004 at ¶¶44-45. One of ordinary skill at the time of filing the ‘582 Patent would
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`have understood “tracking” in the context of image-directed robots to involve
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`placing tracking markers on the target and tracking movements within a defined
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`coordinate system. Taylor’s strain gauge system does not perform a comparable
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`function. See Ex. 2004 at ¶¶44-45.
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`A person of ordinary skill in the art would have understood Taylor to be
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`describing the use of strain gauges to monitor whether the bone might have
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`(possibly transitorily) moved out of its presumed static alignment with the pre-
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`operative CT image. In a system like Taylor’s that is based on a fundamental
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`assumption that the workpiece does not move, it was important to confirm that
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`assumption by use of a gauge that monitored the workpiece’s position. A person
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`of ordinary skill in the art would not understand Taylor to be teaching a tracking
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`system for the workpiece because such a person would want to track the location
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`of something that was presumed to move – the exact opposite of the presumption
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`underlying the Taylor system. See Ex. 2004 at ¶45. In a system in which the
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`workpiece is expected to move, it is important to determine position and location
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`so that the movement can be understood and dynamically accounted for during an
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`operation. That is how a person of ordinary skill the art would understand the term
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`“tracking” to be used in the ’582 Patent claims. Further, a person of ordinary skill
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`in the art at the time would not have understood a strain gauge output to be
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`“tracking data.” See Ex. 2004 at ¶¶44-45. The recited “tracking data” necessarily
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`implies output in terms of values related to a location within a coordinate system,
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`and there is no disclosure in Taylor that its strain gauges provide any values based
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`on the position or orientation of the bone within a coordinate system. It is not
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`possible to track the movement or location of an object in a coordinate system
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`without such positional values. See Ex. 2004 at ¶¶44-45. One of ordinary skill in
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`the art (in light of the ‘582 Patent specification)