`
`Patent No. 6,205,411
`Petition For Inter Partes Review
`
`
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`______________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`______________________
`
`
`Mako Surgical Corp.
`Petitioner
`
`v.
`
`Blue Belt Technologies, Inc.
`Patent Owner
`
`Patent No. 6,205,411
`Issue Date: March 20, 2001
`Title: COMPUTER-ASSISTED SURGERY PLANNER AND
`INTRA-OPERATIVE GUIDANCE SYSTEM
`______________________
`
`Case IPR: Unassigned
`____________________________________________________________
`
`DECLARATION OF ROBERT D. HOWE
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`1
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`Mako Exhibit 1004 Page 1
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`
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`I.
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`1.
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`INTRODUCTION
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`I have been retained by Morrison & Foerster LLP in this case as an
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`expert in the relevant art.
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`2.
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`I have been asked to provide my opinions and views on the materials I
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`have reviewed in this case related to U.S. Patent No. 6,205,411 (“the ’411 patent”
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`(Ex. 1001)) and the scientific and technical knowledge regarding the same subject
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`matter as the ’411 patent before and at the earliest effective filing date of
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`November 12, 1998.
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`3. My opinions and underlying reasoning for the opinions are set forth
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`below.
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`II.
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`4.
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`PROFESSIONAL BACKGROUND
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`I am currently the Abbott and James Lawrence Professor of
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`Engineering at Harvard University. I also serve as Area Dean (equivalent to
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`Department Chair) of Bioengineering. I am the director of the BioRobotics
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`Laboratory at Harvard University, which is the home to over a dozen doctoral
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`students, postdoctoral fellows, and visiting scholars. Our research focuses on
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`robotics, particularly robotic manipulation and robot-assisted surgery. Among
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`other projects, we have developed image-guided and minimally invasive surgical
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`robot systems. Our work has been funded by government grants, private
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`foundations, and commercial partners.
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`2
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`5.
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`I earned a bachelor’s degree in physics from Reed College in 1979
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`and Master of Science and Doctor of Philosophy degrees in Mechanical
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`Engineering from Stanford University in 1987 and 1990, respectively.
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`6. My work has resulted in over four issued patents, six patent
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`applications, and approximately 200 peer-reviewed publications.
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`7.
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`A copy of my curriculum vitae that summarizes my education, work
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`history, and publications is in Appendix A.
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`8.
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`I am being compensated at the rate of $395/hour for taking part in this
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`case but have no other relationship to Mako Surgical Corp. My compensation is
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`not dependent on the outcome of this case.
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`III. BASIS FOR OPINION
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`9. My opinions and views set forth in this report are based on my
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`education, training, and experience in the relevant field, as well as the materials I
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`reviewed in this case, and the scientific knowledge regarding the same subject
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`matter that existed prior to the earliest effective filing date of the ’411 patent.
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`IV. PATENT LAW STANDARD
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`10.
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`It is my understanding that a patent claim is invalid for anticipation if
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`it can be shown that each and every limitation of the claim is disclosed either
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`expressly or inherently in a single prior art reference.
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`11.
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`It is my understanding that a patent claim is invalid for obviousness if
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`the claimed invention as a whole would have been obvious to one of ordinary skill
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`in the art at the time the invention was made, in view of a single prior art reference
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`or a combination of prior art references. Specifically, I understand that a
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`determination of whether a claimed invention would have been obvious requires
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`taking into consideration factors which include: (a) assessing the scope and content
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`of the prior art; (b) the differences between the claimed invention and the prior art;
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`and (c) the level of ordinary skill in the art.
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`12.
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`It is my understanding that when combining two or more references,
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`or when modifying an item disclosed in one reference, so as to arrive at a claimed
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`invention, one should consider whether there is a reason for the proposed
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`combination or modification. For example, when a technology or product is
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`available in one field of endeavor, design incentives and other market forces can
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`prompt variations of it, either in the same field or a different one. For the same
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`reason, if a technique has been used to improve one device and a person of
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`ordinary skill in the art would recognize that it would improve similar devices in
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`the same way, using the technique is obvious unless its actual application is
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`beyond his or her skill.
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`13.
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`It is my understanding that the claims of a patent are analyzed from
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`the perspective of “a person of ordinary skill in the art” and that the claims of the
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`’411 patent are interpreted as a person of ordinary skill in the art would have
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`understood them at the time the ’093 application, which issued as the ’411 patent,
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`was filed. It is further my understanding that a claim is given the “broadest
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`reasonable construction in light of the specification” in inter partes review. See
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`37 C.F.R. § 42.100(b).
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`14.
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`It is my understanding that “prior art” includes patents and
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`publications in the relevant literature and information that predate the effective
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`priority date of the ’411 patent. It is also my understanding that priority is
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`determined on a claim-by-claim basis.
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`15.
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`It is my understanding that a patent application can disclose prior
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`technologies as prior art in its specification, and the admitted prior information can
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`be used as “prior art” against its claims.
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`V. A PERSON OF ORDINARY SKILL IN THE ART
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`16. A person of ordinary skill in the art relevant to the ’411 patent would
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`have had at least a bachelor’s degree in mechanical, electrical, or biomedical
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`engineering or computer science and at least five years of experience developing or
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`researching image-guided medical devices and procedures or surgical robotics.
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`VI. OVERVIEW OF THE APPLICABLE TECHNOLOGIES
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`17. The ’411 patent is directed to systems and methods for facilitating
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`implantation of an artificial component in a hip joint, knee joint, hand and wrist
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`5
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`joint, elbow joint, shoulder joint, or foot and ankle joint. The apparatus and related
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`method consist of essentially two pieces: a pre-operative geometric planner, and a
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`pre-operative kinematic biomechanical simulator that communicates with the
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`geometric planner.
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`18. The ’411’s claimed systems and methods, however, were not new
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`when the ’411 patent was filed. Rather, they were disclosed in articles published
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`well before what I am informed is the earliest effective filing date to which the
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`’411 patent is entitled.
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`19. At least as early as 1996, authors A.M. DiGioia III, D.A. Simon, B.
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`Jaramaz, M. Blackwell, F. Morgan, R.V. O’Toole, B. Colgan, and E. Kischell
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`published HipNav: Pre-operative Planning and Intra-operative Navigational
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`Guidance for Acetabular Implant Placement in Total Hip Replacement Surgery,
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`2nd CAOS Symposium, 1996 (“DiGioia”) (Ex. 1005). DiGioia describes in detail
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`the exact systems and methods that were then claimed two years later in the ’411
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`patent.
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`20. DiGioia discusses a system and methods to determine optimal implant
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`placement during hip replacement surgery through the use of pre-operative
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`planning, a range of motion simulator, and intra-operative navigational tracking
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`and guidance. It describes that a common problem causing complications after hip
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`replacement surgery is poor positioning of the implant. The DiGioia system,
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`6
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`called HipNav, allowed the surgeon to specify a component position, after which
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`the range of motion simulator would estimate femoral range of motion based on
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`parameters provided by the pre-operative planner. The feedback from the
`
`simulator would allow the surgeon to determine patient-specific optimal implant
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`placement. The intra-operative tracking and guidance helps place the implant in
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`that optimal position, regardless of the position of the patient on the operating
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`table.
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`21. Even earlier, at least as early as 1995, Anthony M. DiGioia III,
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`Branislav Jaramaz, and Robert V. O’Toole III published “An Integrated Approach
`
`to Medical Robotics and Computer Assisted Surgery in Orthopedics,” Proc. 1st
`
`Int’l Symp. on Medical Robotics and Computer Assisted Surgery, pp. 106−111,
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`1995 (“DiGioia II”) (Ex. 1006). DiGioia II describes the same system at a higher
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`level, and discloses most claims of the ’411 patent nearly four years before the
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`’411 patent was filed. The claims that were not precisely disclosed in 1995 are
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`merely obvious variations of what was disclosed, particularly in light of well-
`
`known publications at the time and the knowledge of one of skill in the art.
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`VII. THE ’411 PATENT
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`22. The ’411 patent includes three independent claims and 14 dependent
`
`claims. The independent claims recite:
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`1. An apparatus for facilitating the implantation of an
`artificial component in one of a hip joint, a knee joint, a
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`7
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`hand and wrist joint, an elbow joint, a shoulder joint, and
`a foot and ankle joint, comprising:
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`a pre-operative geometric planner; and
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`a pre-operative kinematic biomechanical simulator in
`communication with said pre-operative geometric
`planner wherein said pre-operative geometric planner
`outputs at least one geometric model of the joint and the
`pre-operative kinematic biomechanical simulator outputs
`a position for implantation of the artificial component.
`
`10. A system for facilitating an implant position for at
`least one artificial component in one of a hip joint, a knee
`joint, a hand and wrist joint, an elbow joint, a shoulder
`joint, and a foot and ankle joint, comprising:
`
`a computer system including;
`
`a pre-operative geometric planner; and
`
`a pre-operative kinematic biomechanical simulator in
`communication with said pre-operative geometric
`planner wherein pre-operative geometric planner outputs
`at least one geometric model of the joint and the pre-
`operative kinematic biomechanical simulator outputs a
`position for implantation of the artificial component; and
`
`a tracking device in communication with said computer
`system.
`
`17. A computerized method of facilitating the
`implantation of an artificial implant in one of a hip joint,
`a knee joint, a hand and wrist joint, an elbow joint, a
`shoulder joint, and a foot and ankle joint, comprising:
`
`creating a three dimensional bone model based on
`skeletal geometric data of a bone and a bony cavity into
`which the artificial implant is to be implanted;
`
`creating a three dimensional component model of the
`artificial implant;
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`8
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`simulating movement of the joint with the artificial
`implant in a test position;
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`calculating a range of motion of the artificial implant and
`the bones comprising the joint for the test position based
`on the simulated movement;
`
`determining an implant position based on a
`predetermined range of motion and the calculated range
`of motion;
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`identifying the implant position in the bone model;
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`aligning the bone model with the patient’s bone and
`placing the implant based on positional tracking data
`providing the position of the implant and the bone; and
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`tracking the implant and the bone to maintain alignment
`of the bone model and to determine the position of the
`implant relative to the bone.
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`23. Dependent claims 2 and 15 add an intra-operative navigational
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`module in communication with the pre-operative kinematic biomechanical
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`simulator. Dependent claim 3 further adds a tracking device in communication
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`with the intra-operative navigational module. Dependent claim 4 specifies that the
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`pre-operative geometric planner is responsive to a skeletal data source. Dependent
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`claim 5 adds further that the skeletal data source includes geometric data.
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`Dependent claim 6 specifies that the pre-operative geometric planner outputs at
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`least one geometric model of the component, and dependent claim 7 adds that the
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`simulator is responsive to the geometric model and outputs an implant position.
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`Dependent claim 8 specifies further that the implant position includes angular
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`9
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`component orientation. Dependent claim 9 adds a list of potential tracking devices
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`for claim 3. Dependent claims 11 through 14 add additional elements to claim 10:
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`a display monitor; a controller; a camera; and a tracking device that includes at
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`least one target, respectively. Dependent claim 16 adds a robotic device in
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`communication with the computer system and a surgical tool connected to the
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`robotic device.
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`VIII. THE PRIOR ART
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`24. Following are brief summaries of the prior art references applied
`
`against the claims of the ’411 patent in this declaration.
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`A.M. DiGioia et al., “HipNav: Pre-operative Planning and Intra-operative
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`Navigational Guidance for Acetabular Implant Placement in Total Hip
`
`Replacement Surgery,” 2nd CAOS Symposium, 1996 (“DiGioia”) (Ex.
`
`1005).
`
`25. DiGioia is an article published at least as early as 1996. (See Ex. 1005
`
`at 1.) DiGioia discusses a system and methods to determine optimal implant
`
`placement during hip replacement surgery through the use of pre-operative
`
`planning, a range of motion simulator, and intra-operative navigational tracking
`
`and guidance. It describes that a common problem causing complications after hip
`
`replacement surgery is poor positioning of the implant. The DiGioia system,
`
`called HipNav, allowed the surgeon to specify a component position, after which
`
`10
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`Mako Exhibit 1004 Page 10
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`
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`the range of motion simulator would estimate femoral range of motion based on
`
`parameters provided by the pre-operative planner. The feedback from the
`
`simulator would allow the surgeon to determine patient-specific optimal implant
`
`placement. The intra-operative tracking and guidance helps place the implant in
`
`that optimal position, regardless of the position of the patient on the operating
`
`table.
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`26. DiGioia discloses: (1) a computer system for facilitating
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`implantation of an artificial component in one of the specified joint types (Ex.
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`1005 at 1 (“[S]ystem allows a surgeon to determine optimal patient specific
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`acetabular implant placement and accurately achieve the desired acetabular implant
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`placement during surgery.”)) with (2) a pre-operative geometric planner (id. at 2
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`(“[P]re-operative planner allows the surgeon to manually specify the position of
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`the acetabular component within the pelvis based upon pre-operative CT images,”
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`and is therefore geometric)) and (3) a pre-operative kinematic biomechanical
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`simulator in communication with the geometric planner (id. at Fig. 3 (depicting
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`range of motion simulator with arrows illustrating communication between
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`simulator and planner)), where (4) the geometric planner outputs a geometric
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`model of the joint (id. at 2 (simulator receives from pre-operative planner implant
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`placement parameters, which are necessarily based upon and described relative to
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`geometric model of joint)), and (5) a tracking device communicating with the
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`11
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`computer system (id. at 4 (intra-operative system includes Optotrak optical
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`tracking camera capable of tracking special LEDs)).
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`27. DiGioia also discloses a computerized method (1) for facilitating
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`implantation of an artificial implant in one of the specified joint types
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`(Ex. 1005 at 1), comprising (2) creating a three-dimensional bone model (id. at
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`2-3, Fig. 8 (system uses pelvic surface model constructed from CT data using
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`techniques discussed in three-dimensional modeling article)), (3) creating a three-
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`dimensional component model (id. at Fig. 4 (depicting positioning of implant
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`component across three orthogonal views of pelvis)), (4) simulating movement of
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`the joint with the artificial implant in a test position (id. at 2 (discussing range
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`of motion simulator)), (5) calculating a range of motion (id. at 3-4 (simulator
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`performs kinematic analysis to determine envelope of safe range of motion)), (6)
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`identifying the implant position in the bone model (id. at 3 (surgeon can
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`position cross sections of implant upon orthogonal view of pelvis)), (7) aligning
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`the bone model with the bone based on tracking data (id. at 5 (disclosing
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`registration process to align position of patient to pre-operative plan)), and (8)
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`tracking the implant and bone to maintain alignment and determine the
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`position of the implant relative to the bone (id. at 5-7 (discussing tracking of
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`implant and bone and use of navigational feedback)).
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`12
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`
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`Anthony M. DiGioia III et al., “An Integrated Approach to Medical Robotics
`
`and Computer Assisted Surgery in Orthopedics,” Proc. 1st Int’l Symp. on
`
`Medical Robotics and Computer Assisted Surgery, pp. 106−111, 1995
`
`(“DiGioia II”) (Ex. 1006).
`
`28. DiGioia II is an article published at least as early as 1995. Much like
`
`DiGioia, DiGioia II describes systems and methods to improve accuracy of joint
`
`replacements through the use of pre-operative planning and computer systems.
`
`DiGioia proposes a pre-operative planning component. DiGioia II discloses use of
`
`what could be construed as a simulator to determine optimal implant positioning.
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`It describes that if biomechanics-based preoperative planning is linked with patient
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`and pre-determined implant data, as well as a computer or robot monitoring and
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`assisting the surgery, surgical results could be improved. A main figure in the
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`article, Figure 1, displays the combined system, indicating with arrows
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`communication between the various components.
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`29. Like the ’411 patent and the DiGioia reference discussed above,
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`DiGioia II discloses an approach to improved surgical techniques incorporating
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`pre-operative planning with biomechanical analysis and computer or robot-assisted
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`surgery. (Ex. 1006 at 3.) Like the system disclosed in the ’411’s independent
`
`system claims 1 and 10, DiGioia II discloses a computer system (1) for facilitating
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`implantation of an artificial component in one of the specified joint types
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`13
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`(Ex. 1006 at Fig. 1 (depicting cup and femoral implants)) with (2) a pre-operative
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`geometric planner (id. (depicting “Biomechanics-based Preoperative Planning”
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`portion of system with “3-D Templating”)); where (3) the geometric planner
`
`outputs a geometric model of the joint (id. (depicting that 3-D templating
`
`subsystem of pre-operative planner outputs geometric model of bones to
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`biomechanical analyzer subsystem)); and (4) the biomechanical simulator
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`outputs a position for implantation of the artificial component (id. at 108-09
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`(stating that “the simulation may help indicate an ‘optimal’ bone cavity shape and
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`implant location”); Fig. 1 (depicting return arrow from biomechanical analyzer
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`subsystem, indicating that shape and location is being output back to planner)).
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`30. DiGioia II also discloses what could be construed as a pre-operative
`
`kinematic biomechanical simulator in communication with the geometric planner
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`(Ex. 1006 at Fig. 1 (depicting biomechanical analysis system, shown to be in
`
`communication with geometric planner via arrows); id. at 107 (stating system will
`
`“provide the surgeon with feedback concerning the distribution of strain in the
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`bone, and the amount of bone-implant contact for a given surgical plan” and
`
`consider “bone remodeling effects due to joint loading and varying load transfer
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`mechanisms,” which relates to movement and is therefore a kinematic
`
`biomechanical simulator)). Moreover, even if one does not consider this system to
`
`be a simulator within the meaning of the ’411 specification and file history, such
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`simulators were well-known in the art at the relevant time, as discussed in more
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`detail below, and it would have been obvious to combine such a simulator with the
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`system described in DiGioia II.
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`31. Similarly, like the method disclosed in the ’411’s independent method
`
`claim 17, DiGioia II discloses a computerized method (1) for facilitating
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`implantation of an artificial implant in one of the specified joint types
`
`(Ex. 1006 at Fig. 1 (depicting computer and robotic surgical system for performing
`
`hip replacement surgeries)), comprising (2) creating a three-dimensional bone
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`model (id. (depicting software that utilizes radiological imaging data to generate 3-
`
`D skeleton models as well as database of implant models, which are provided to
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`planning software that generates 3-D templates from models which then allow
`
`biomechanical simulator to evaluate selected implant position); Fig. 2 (depicting
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`bone model, implant model, and bony cavity into which implant model is
`
`implanted)), (3) creating a three-dimensional component model (id. at Fig. 1
`
`(depicting computer with implant database used to generate 3-D model of
`
`implant)), and (4) identifying the implant position in the bone model (id. at Fig.
`
`2 (depicting implant position in cavity of bone model)). As noted above, DiGioia
`
`II also could be construed to disclose simulating movement of the joint with the
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`artificial implant in a test position (id. at 107 (describing biomechanical analysis
`
`system that will “provide the surgeon with feedback concerning the distribution of
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`strain in the bone, and the amount of bone-implant contact for a given surgical
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`plan” and consider “bone remodeling effects due to joint loading and varying load
`
`transfer mechanisms,” which relate to movement and are therefore a kinematic
`
`biomechanical simulator)), and in any event, such simulating was well-known in
`
`the art at the relevant time, as discussed in more detail below.
`
`E.Y.S. Chao et al., “Simulation and Animation of Musculoskeletal Joint
`
`System,” Transactactions of the ASME, Vol. 115, pp. 562-568, Nov. 1993
`
`(“Chao”) (Ex. 1007).
`
`32. Chao is an article published in November 1993. Chao addresses the
`
`same subject matter as DiGioia II: simulation and animation of joints. Chao
`
`expresses a desire to allow a user to simulate joint pressure distribution in order to
`
`improve joint replacement, including hip replacements. It discusses numerous
`
`types of simulators. A person of ordinary skill in the art would have been
`
`motivated to combine DiGioia II with Chao, as Chao was published only
`
`approximately 1-2 years before DiGioia II and addresses the same subject matter
`
`as DiGioia II. Like DiGioia II, Chao addresses simulation and animation of joints.
`
`Also like DiGioia II, Chao expresses a desire to allow a user to simulate joint
`
`pressure distribution in order to improve joint replacement, including hip
`
`replacements.
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`16
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`Mako Exhibit 1004 Page 16
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`R.V. O’Toole III et al., “Towards More Capable and Less Invasive Robotic
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`Surgery in Orthopaedics,” Computer Vision, Virtual Reality and Robotics in
`
`Medicine Lecture Notes in Computer Science, Vol. 905, pp. 123-130, 1995
`
`(“O’Toole”) (Ex. 1008).
`
`33. O’Toole is an article published in 1995. O’Toole describes a system
`
`for planning a hip surgery involving a femoral implant and a femur and shares
`
`most of its authors with DiGioia II. A person of ordinary skill would be motivated
`
`to combine DiGioia II with O’Toole, as O’Toole also describes a system for
`
`planning a hip surgery involving a femoral implant and a femur and shares most of
`
`its authors with DiGioia II (including respective lead authors O’Toole and DiGioia
`
`along with four other authors).
`
`Russell H. Taylor et al., An Image-Directed Robotic System for Precise
`
`Orthopaedic Surgery, IEEE Transactions on Robotics and Automation,
`
`Vol. 10, No. 3, June 1994 (“Taylor”) (Ex. 1009).
`
`34. Taylor is an article published June 1994. Taylor describes an “image-
`
`directed robotic system to augment the performance of human surgeons” and
`
`explains that “[o]rthopaedic applications represent a particularly promising domain
`
`for the integration of image and model-based presurgical planning, CAD/CAM
`
`technology, and precise robotic execution.” (Ex. 1009 at 261-62.) The Taylor
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`system uses 3-D imaging, registration, and tracking of the cutting tool and a
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`Mako Exhibit 1004 Page 17
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`workpiece, for example a leg or bone, with control based on that data. A person of
`
`ordinary skill would be motivated to combine DiGioia II with Taylor, as Taylor
`
`was well-known in the mid-1990s to those of skill in the art, and like DiGioia II,
`
`Taylor addresses a system to improve accuracy of orthopedic surgery.
`
`IX. VALIDITY
`
`35.
`
`In my opinion, claims 1-17 of the ’411 patent are anticipated by, or
`
`obvious in view of, the prior art references discussed above separately or in
`
`combination, for the reasons discussed below.
`
`DiGioia
`
`36. Claims 1-17 are obvious in view of DiGioia in light of the knowledge
`
`of one of skill in the art or in combination with DiGioia II. The majority of the
`
`elements in claims 1-17 are literally disclosed in DiGioia. The few elements that
`
`are not literally disclosed are obvious variations of the elements that are disclosed
`
`and are discussed in more detail below.
`
`37. A person having ordinary skill in the art would have been motivated
`
`to combine DiGioia with DiGioia II. DiGioia II is an earlier article written by
`
`several of the same authors, including of course DiGioia himself. DiGioia II
`
`addresses the same concerns as DiGioia. In many respects, DiGioia II disclosed
`
`the same system discussed in DiGioia, at a higher level and several years before.
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`38. Claims 1 and 10 require the use of feedback from a simulator to
`
`output a position for implantation of the artificial component. Similarly, claim 7
`
`requires the simulator to be responsive to the geometric model and output an
`
`implant position. The DiGioia system discloses that feedback from the simulator
`
`can aid the surgeon in determining optimal implant placement. (Ex. 1005 at 2.) It
`
`would have been obvious to one of skill in the art to utilize the feedback as
`
`suggested by DiGioia, re-run the simulation to determine optimal positioning of
`
`the component, and have the simulator output that position. In fact, this is
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`suggested by Figure 3 in DiGioia, which depicts bi-directional communication
`
`between the pre-operative planner and the range of motion simulator.
`
`39. Claim 9 adds that the tracking device must be selected from the group
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`consisting of an acoustic tracking system, shape based recognition tracking system,
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`video-based tracking system, mechanical tracking system, electromagnetic tracking
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`system and radio frequency tracking system, and claim 13 requires that the
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`tracking device include at least one camera. DiGioia discloses an Optotrak
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`camera-based tracking system. (Ex. 1005 at 4.) Even if this was not considered a
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`video-based tracking system, video-based tracking systems were widely used and
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`known to those of skill in the art in the mid-1990s, and it would have been obvious
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`to combine video-based capability with the DiGioia system or substitute a video-
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`based tracking system for the Optotrak camera system.
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`19
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`Mako Exhibit 1004 Page 19
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`
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`40. Claim 16 adds the requirement of a robotic device and surgical tool.
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`Although a robotic device with a surgical tool is not explicitly disclosed in
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`DiGioia, it was explicitly disclosed in DiGioia II. Figure 1 of DiGioia II shows a
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`ceiling-mounted robotic arm with a surgical tool at the end of the arm. (Ex. 1006
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`at Fig. 1.) As noted above, it would have been obvious to one of skill in the art to
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`look to DiGioia II when solving problems addressed by DiGioia, as DiGioia II is
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`an article addressing the same problems, published by the same authors, just a few
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`years before the publication of DiGioia. It therefore would have been obvious to
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`one of skill in the art to combine the robotic device and surgical tool from DiGioia
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`II with the system discussed in more detail in DiGioia.
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`41. Claim 17 requires the system to determine an implant position based
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`on both a pre-determined range of motion and a calculated range of motion.
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`DiGioia explicitly discloses calculation of a range of motion and states the surgeon
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`may choose to modify a selected position to achieve optimal implant positioning.
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`Particularly in light of the suggestion that a surgeon may want to modify the
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`calculated range of motion, it would have been obvious to one of skill in the art to
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`determine the ideal modification by taking into account pre-determined functional
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`needs and the range of motion needed to meet those needs.
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`42.
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`I have reviewed the DiGioia claim chart in the petition to be filed with
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`my declaration and agree with all the statements about the factual findings and
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`20
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`Mako Exhibit 1004 Page 20
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`arguments based on those findings. It is my opinion that the claims of the ’411
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`patent are anticipated or rendered obvious as set forth in this chart and as
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`additionally addressed in this declaration.
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`DiGioia II
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`43. Claims 1-17 are also anticipated by DiGioia II or obvious in view of
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`DiGioia II in light of the knowledge of one of skill in the art or in combination
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`with Chao, O’Toole, or Taylor.
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`44. Several claims of DiGioia II require a kinematic biomechanical
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`simulator. As noted above, the system described in DiGioia II could be considered
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`such a simulator. (See, e.g., Ex. 1006 at Fig. 1 (depicting biomechanical analysis
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`system, shown to be in communication with geometric planner via arrows); id. at
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`107 (stating system will “provide the surgeon with feedback concerning the
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`distribution of strain in the bone, and the amount of bone-implant contact for a
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`given surgical plan” and consider “bone remodeling effects due to joint loading
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`and varying load transfer mechanisms,” which relates to movement and is
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`therefore a kinematic biomechanical simulator).) Moreover, even if one adopts a
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`more restrictive view of “simulator,” as noted above, a person of ordinary skill in
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`the art would be motivated to combine DiGioia II with Chao. Chao indicates that
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`its simulations may be used for “Selection and Planning in Total Joint
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`Replacement” and discloses examples where “[j]oint pressure and motion were
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`21
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`Mako Exhibit 1004 Page 21
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`
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`obtained through model simulation.” (Ex. 1007 at 565.) It would have been
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`obvious to one of skill in the art to combine simulations discussed in Chao with the
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`system discussed in DiGioia II. Also, as with DiGioia, it would have been obvious
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`to one of skill in the art to utilize the feedback as suggested by DiGioia II, re-run
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`the simulation to determine optimal positioning of the component, and have the
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`simulator output that position.
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`45. Claims 2 and 15 require an intra-operative navigational module in
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`communication with the pre-operative kinematic biomechanical simulator.
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`DiGioia II indicates that “surgical robots actually improve the clinical usefulness
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`of realistic surgical simulations” and that “surgical simulations also increase the
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`utility of surgical robots.” (Ex. 1006 at 109.) A surgical robot necessarily includes
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`an intra-operative navigational module to accurately perform the surgical
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`procedures, and Figure 1 of DiGioia II depicts the communication between an
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`intra-operative navigational module and the pre-operative kinematic biomechanical
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`simulator, via the pre-operative planner.
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`46. Claim 3 requires a tracking device in communication with said intra-
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`operative navigational module. DiGioia II discloses that its system includes a
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`computer assisted or robot-assisted surgery system component, as shown in Figure
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`1, but does not expressly disclose any tracking device that used with a robot-
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`assisted surgery system. It would have been obvious to include a tracking system
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`22
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`Mako Exhibit 1004 Page 22
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`such as one described in O’Toole. As noted above, O’Toole is an article written by
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`several of the same authors and published in 1995. As noted above, a person of
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`ordinary skill would be motivated to combine DiGioia II with O’Toole. O’Toole
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`states that with the use of high speed tracking, the bone being milled does not have
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`to be rigidly fixated. This necessarily requires th
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