UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________
`
`Mako Surgical Corp.
`Petitioner
`
`v.
`
`Blue Belt Technologies, Inc.
`Patent Owner
`
`_____________________
`
`CASE NO: IPR2015-00630
`PATENT NO: 6,205,411
`_____________________
`
`DECLARATION OF DR. KEVIN CLEARY
`
`Mail Stop Patent Board
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Blue Belt Technologies, Inc.
`Exhibit 2003
`Mako Surgical Corp. v. Blue
`Belt
`Technologies, Inc.
`IPR2015-00630
`
`1
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`Blue Belt - Exhibit 2003 - Page 1
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`
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`TABLE OF CONTENTS
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`INTRODUCTION AND QUALIFICATIONS ............................................... 3
`I.
`PROFESSIONAL QUALIFICATIONS ......................................................... 3
`II.
`III. LEVEL OF ORDINARY SKILL IN THE ART ............................................. 6
`IV. APPLICABLE LEGAL STANDARD ............................................................ 9
`A.
`Claim Construction ............................................................................... 9
`B.
`Obviousness ........................................................................................... 9
`The ’976 Patent. ............................................................................................. 10
`V.
`VI. THE ’411 PATENT ....................................................................................... 15
`VII. CITED REFERENCES ................................................................................. 23
`A. DiGioia ................................................................................................ 23
`B.
`DiGioia II ............................................................................................ 24
`C.
`Taylor .................................................................................................. 26
`D.
`Chao ..................................................................................................... 27
`E.
`O’Toole................................................................................................ 27
`VIII. Obviousness of claims 1–15 and 17 over DiGioia ........................................ 28
`A.
`“the pre-operative kinematic biomechanical simulator outputs a
`position for implantation of the artificial component,” as recited
`in independent claims 1 and 10. .......................................................... 28
`“wherein said pre-operative geometric planner outputs at least
`one geometric model of the joint,” as recited in independent
`claims 1 and 10. ................................................................................... 33
`“creating a three dimensional component model of the artificial
`implant,” as recited in independent claim 17. ..................................... 35
`IX. Proposed Substitute Claims 18–34 ................................................................ 36
`
`B.
`
`C.
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`2
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`Blue Belt - Exhibit 2003 - Page 2
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`I.
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`INTRODUCTION AND QUALIFICATIONS
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`1.
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`I have been retained on behalf of Blue Belt Technologies, Inc., to
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`provide this Declaration concerning technical subject matter relevant to the inter
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`partes review of U.S. Patent No. 6,205,411 (“the ’411 Patent”) (Ex. 1001).
`
`2.
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`I am over 18 years of age. I have personal knowledge of the facts
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`stated in this Declaration and could testify competently to them if asked to do so.
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`II.
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`PROFESSIONAL QUALIFICATIONS
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`3. My name is Kevin Robert Cleary. I currently reside at 8416
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`Buckhannon Drive, Potomac, MD 20854. I hold a Doctor of Philosophy degree in
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`Mechanical Engineering from the University of Texas, and Bachelor of Science
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`and Master of Science degrees in Mechanical Engineering and Materials Science
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`from Pratt School of Engineering at Duke University. I was a postdoctoral
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`researcher in robotics at the Mechanical Engineering Laboratory in Tsukuba, Japan
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`in 1990.
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`4.
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`I have more than 15 years of experience as an engineer, research
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`investigator, and professor in the image-guided surgery industry. I am currently
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`the Technical Director of the Bioengineering Initiative at the Sheikh Zayed Center
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`for Pediatric Surgical Innovation at the Children’s National Medical Center in
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`Washington, D.C. and a Professor at the School of Health Sciences at George
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`Washington University. My past experiences include experience as a Research
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`3
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`Blue Belt - Exhibit 2003 - Page 3
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`Professor and Director at the Imaging Science and Information Systems (ISIS)
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`Center in the Georgetown University Radiology Department.
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`5.
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`I have played numerous roles in advancing the field of image-guided
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`surgery and medical robotics. I have been actively involved in the field of robotics
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`since at least 1986 and in the field of medical imaging since at least 1996. From
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`January 1994 to December 1996 I served as a Robotics System Engineer and
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`Group Leader at Global Associates Ltd., Inc. in Arlington, VA, where I started a
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`program to demonstrate the usefulness of robots to Federal Agencies. From
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`January 1996 to January 2000, I served as a Research Assistant Professor at the
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`Imaging Science and Information Systems Center in the Department of Radiology
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`of Georgetown University. As a Research Assistant Professor, I developed “tele-
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`radiology” systems that allow for remote imaging of a patient using, for example,
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`computed tomography (CT) scan data. During this time, I also developed image-
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`guided medical intervention technologies that helped guide medical procedures
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`using medical image data.
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`6.
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`I was the principal organizer of a 2004 conference titled “Operating
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`Room of the Future” with topics including image-guided surgery and medical
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`robotics. I led the world’s first clinical trial of robotically assisted spine blocks at
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`Georgetown University. My research was funded by the National Institute of
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`Health (NIH) through the R01 grant mechanism to develop an open-source
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`software toolkit for image-guided surgery. (The R01 grant mechanism provides
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`support for health-related research and development.) This toolkit was used by
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`more than 20 research groups worldwide. I led the team that did the world’s first
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`image-guided liver biopsy at Georgetown University using electromagnetic
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`tracking. This work was recently extended to PET-CT guided biopsy. I have
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`written review articles on image-guided surgery and medical robotics. I was the
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`co-editor of popular book in the field titled “Image-Guided Interventions.” At
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`Children’s National Medical Center I am currently managing projects in image-
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`guided surgery, medical robotics, and biomedical devices.
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`7.
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`Attached hereto as Appendix A is a true and correct copy of my most
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`recent CV describing my education, employment history, publications,
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`professional activities and awards, and patents.
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`8.
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`In light of the foregoing, I consider myself to be an expert in the fields
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`of image-guided medical devices and surgical robotics, and believe that I am
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`qualified to provide an opinion as to what a person of ordinary skill in the art
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`would have understood, known, or concluded regarding the subject matter of the
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`’411 Patent at the time of its earliest priority date, which I understand to be in or
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`around February 1997.
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`9.
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`I am being compensated for my time spent on this matter at a rate of
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`$300 per hour. My compensation is in no way contingent on the outcome of this
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`proceeding or on the opinions I develop in this matter.
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`10.
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`In the past four years I have not testified in any litigation matters.
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`11. My preliminary opinions expressed herein are based on review and
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`analysis of certain information obtained in connection with my work on this
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`matter, together with my training, education, and experience. The opinions
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`expressed herein are my own.
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`12.
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`In my analysis, I considered the ’411 Patent and its file history, U.S.
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`Patent No. 5,880,976 (“the ’976 Patent”) (Ex. 2004), the Petition (Paper No. 2) and
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`the references cited therein, the Declaration of the Petitioner’s expert, Dr. Robert
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`Howe (Ex. 1004) (“Howe Decl.”), and the Institution Decision (Paper No. 6). In
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`addition, I refreshed myself on the state of the art in 1997.
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`III. LEVEL OF ORDINARY SKILL IN THE ART
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`13. Throughout this report, I consider the issues from the perspective of a
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`person having ordinary skill in the art in or around February 1997, the earliest date
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`to which the ’411 Patent claims priority.
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`14. The ’411 Patent is titled “Computer-assisted Surgery Planner and
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`Intra-Operative Guidance System” and describes a surgical planning and
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`navigation system. Generally categorized, the ’411 Patent deals with pre-operative
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`planning and intra-operative navigation.
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`15.
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`In determining the characteristics of a hypothetical person of ordinary
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`skill in the art around February 1997 for the technology described in the ’411
`
`Patent, I considered a number of factors, including how pre-operative planners and
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`intra-operative navigation systems were designed and implemented at and before
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`that time, the nature of problems encountered in this field, and the pace at which
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`innovations were made at that time. I also considered the educational background
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`and experience of those actively working in the field. Finally, I placed myself
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`back in 1997 and considered the engineers that I worked with on image-guided
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`medical devices and robotics systems.
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`16.
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`It is my opinion that for the purposes of the ’411 Patent, a person of
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`ordinary skill in the art, at the time the patent was filed, would be one having a
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`Master’s or Doctorate degree with a concentration in mechanical or medical
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`engineering from an accredited engineering program with an area of emphasis of
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`image-guided medical devices or medical robotics. The characteristics of a person
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`of ordinary skill in the field of art of the ’411 Patent would include a working
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`knowledge of image-guided medical devices and surgical robot design. I
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`recognize that someone with less technical education but more practical
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`experience, or more technical education but less practical experience, could also
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`have been considered a person of ordinary skill in the art.
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`17.
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`I also note that Dr. Howe asserts that a person of ordinary skill would
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`have at least five years of experience developing or researching image-guided
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`medical devices and procedures or surgical robots. Howe Decl., ¶ 16. In my
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`experience, five years of experience was not needed for a person to be considered
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`one of ordinary skill in the art. In my opinion, one of ordinary skill in the art had
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`at least two years of experience developing or researching image-guided medical
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`devices and procedures or surgical robots. In and around 1997, I was engaging in
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`cutting-edge research in image-guided medical devices with many individuals who
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`I considered to be ones of ordinary skill yet did not yet have five years of
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`experience. I note further that, based on the publications listed in his curriculum
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`vitae, Dr. Howe does not appear have had at least five years of experience in
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`image-guided medical devices by February 1997, further indicating that five years
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`of experience was not necessary for a person to be considered one of ordinary skill.
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`Finally, I recognize that someone with less technical education but more practical
`
`experience, or more technical education but less practical experience could also
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`have been considered a person of ordinary skill in the art.
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`Blue Belt - Exhibit 2003 - Page 8
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`IV. APPLICABLE LEGAL STANDARD
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`A. Claim Construction
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`18.
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`I have been informed by counsel and therefore understand that the
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`first step in determining the patentability of an asserted claim is for the claim to be
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`properly construed.
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`19.
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`I understand that in proceedings before the Board, patent claims are to
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`be given their broadest reasonable interpretation, consistent with the teachings of
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`the specification and file history.
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`B. Obviousness
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`20.
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`I understand that a patent claim is unpatentable as “obvious” under 35
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`U.S.C. § 103 in light of one or more prior art references if it would have been
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`obvious to one of ordinary skill in the art, taking into account (1) the scope and
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`content of the prior art, (2) the differences between the prior art and the claims,
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`(3) the level of ordinary skill in the art, and (4) any so-called “secondary
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`considerations” of non-obviousness, which include: (i) “long felt need” for the
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`claimed invention, (ii) commercial success attributable to the claimed invention,
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`(iii) unexpected results of the claimed invention, and (iv) “copying” of the claimed
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`invention by others.
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`21. For purposes of my analysis above, I have applied a date of February
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`21, 1997, as the date of invention in my obviousness analyses, although in many
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`cases the same analysis would hold true even at a later time than February 21,
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`1997.
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`22.
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`I understand that a claim can be obvious in light of a single prior art
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`reference or multiple prior art references. To be obvious in light of a single prior
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`art reference or multiple prior art references, there must be a reason to modify the
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`single prior art reference, or combine two or more references, in order to achieve
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`the claimed invention. This reason may come from a teaching, suggestion, or
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`motivation to combine, or may come from the reference or references themselves,
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`the knowledge or “common sense” of one skilled in the art, from market forces, or
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`from the nature of the problem to be solved, and may be explicit or implicit from
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`the prior art as a whole. I also understand that the combination of familiar
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`elements according to known methods is likely to be obvious when it does no more
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`than yield predictable results. I also understand it is improper to rely on hindsight
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`in making the obviousness determination.
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`V. The ’976 Patent.
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`23.
`
`I understand that the ’411 Patent claims priority to the ’976 Patent.
`
`The ’976 Patent describes apparatuses and methods that include “creating a joint
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`model of a patient's joint into which an artificial component is to be implanted and
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`creating a component model of the artificial component.” ’976 Patent, 4:60–63.
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`These models are used to “simulate movement of the patient's joint with the
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`10
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`artificial component in a test position” and to “calculate a range of motion of the
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`joint for at least one test position based on the simulated movement.” Id., 4:63–5:1.
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`“An implant position, including angular orientation, for the artificial component is
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`determined based on a predetermined range of motion and the calculated range of
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`motion.” Id., 5:1–4.
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`24. Figure 1 of the ’976 Patent, which I have provided below, shows an
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`apparatus 10 that includes a geometric pre-operative planner 12, a pre-operative
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`kinematic biomechanical simulator 14, and intra-operative navigational software
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`16. Id., 5:63–6:8. Geometric pre-operative planner 12 is used to create “geometric
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`models of the joint and the components to be implanted based on geometric data
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`received from skeletal structure data source 13.” Id., 6:18–20. Pre-operative
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`biomechanical simulator 14 simulates the “movement of the joint using the
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`geometric models,” and the simulation results are used to determine an implant
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`position for the artificial component. Id., 6:22–25. Intra-navigational software 16
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`uses the implant position and the geometric models to guide a medical practitioner
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`in the placement of the implant component. Id., 6:25–28.
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`11
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`Blue Belt - Exhibit 2003 - Page 11
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`25. Figure 2 of the ’976 Patent, which I have provided below, shows a
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`flowchart that illustrates the operation of apparatus 10. Id., 7:3–4. The flowchart
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`of Figure 2 includes steps 40–48 which represent a pre-operative procedure 50, and
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`steps 52–56, which represent a “procedure 60 which enables a surgeon to realize
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`the desired implant position in the surgical theater.” Id., 8:17–23. Moreover, the
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`’976 Patent describes the operation of apparatus 10 with reference to a joint in
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`general and specifically with reference to a total hip replacement (THR) surgery.
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`Id., 9:45–46. A THR surgery involves placing an acetabular cup into the patient’s
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`acetabulum and a femoral implant into the patient’s femur. Id., 9:46–56.
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`12
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`Blue Belt - Exhibit 2003 - Page 12
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`26.
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`In step 40, the skeletal structure of the joint is determined using
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`tomographic or computed tomographic data, e.g., computed tomography (CT),
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`magnetic resonance imaging (MRI), positron emission tomographic (PET), or
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`ultrasound scanning. Id., 7:4–12. In step 42, a surface model of the joint is created
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`from the skeletal structure of the joint, and geometric models of the artificial
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`components are created. Id., 7:22–38. In step 44, the geometric models of the
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`joint and artificial components are used to simulate movement of the joint
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`containing the implanted artificial components. Id., 7:40–43. For example, in a
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`THR surgery, the skeletal structure of the patient’s femur and pelvic regions can be
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`obtained via CT scans and used to create geometric surface models of the patient’s
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`pelvis and femur. Id., 9:57–65. Simulations can be conducted with the acetabular
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`cup and the femoral implant implanted at various test locations using the following
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`parameters: head-to-neck ratio of the femoral implant, the position of the
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`acetabular cup, and the relative position of the femoral implant with respect to the
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`cup. Id., 10:20–29.
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`27.
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`In step 46, the simulated range of motion is used to calculate a range
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`of motion, and in step 48 the calculated ranges of motion are compared to the
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`predetermined range of motion to select an implant position for the artificial
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`components. Id., 7:66–8:3. The selection of an implant position can be automated
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`such that a position is automatically output or manual control can be provided over
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`13
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`the selection of implants and/or implant locations. Id., 7:55–65. In the example of
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`THR surgery, the implant location can be determined by comparing the calculated
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`range of motion with the predetermined range of motion. Id., 11:1–5.
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`28.
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`In step 52, the implant positions are identified in the geometric model
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`of the joint. Id., 8:24–27. In step 54, the joint model generated in the pre-
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`operative stage is aligned with the intra-operative position of the patient’s joint.
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`Id., 8:33–37. Registration can involve locating coordinates of points on the bony
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`surface using a probe, and those points can be registered with the pre-operative
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`plan. Id., 8:38–43. For example, positional data from discrete locations on the
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`patient’s pelvis and femur can be used as inputs to the registration process. Id.,
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`11:20–23.
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`29.
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`In step 56, the positions of the joint and of the implant components are
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`tracked and compared in near real time to the implant position identified in the
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`joint model. Id., 9:26–28. Intra-navigational software 16 can be used to determine
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`the relative position of the artificial component and the implant position. Id., 9:31–
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`35. For example, intra-navigational software 16 can display on a monitor the
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`relative position of the near real time position of the acetabular cup and the pre-
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`operatively specified implant position. Id., 11:50–54.
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`VI. THE ’411 PATENT
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`30. The ’411 Patent relates to apparatuses, systems, and methods for
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`“facilitating the implantation of an artificial component” in a joint. ’411 Patent,
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`Abstract. I note that the ’411 Patent shares much of the same text as the ’976
`
`Patent. Figures 1–3, 4a–c, 5a–c, 6, 7a–e, 8, 9a–b, and 10a–b are identical in the
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`’976 Patent and the ’411 Patent. Moreover, the description of a THR surgery in
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`the ’976 Patent at 9:45–12:8 is substantively identical to the description of a THR
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`surgery in the ’411 Patent at 9:46–12:9.
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`31. The ’411 Patent includes claims 1–17, of which claims 1, 10, and 17
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`are independent. I have provided independent claims 1, 10, and 17 below.
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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 hand and wrist joint,
`an elbow joint, a shoulder joint, and a foot and ankle joint,
`comprising:
`
`a pre-operative geometric planner; and
`
`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
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`16
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`Blue Belt - Exhibit 2003 - Page 16
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`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
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`a tracking device in communication with said computer system.
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`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;
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`creating a three dimensional component model of the artificial
`implant;
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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;
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`determining an implant position based on a predetermined
`range of motion and the calculated range of motion;
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`17
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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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`32.
`
`I note that independent claims 1, 10, and 17 recite an apparatus,
`
`system, and method, respectively, for “facilitating the implantation of an artificial
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`component in one of a hip joint, a knee joint, a hand and wrist joint, an elbow joint,
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`a shoulder joint, and a foot and ankle joint.” Of the group of joints claims 1, 10,
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`and 17 recite, only the hip joint is expressly mentioned in the ’976 Patent. In my
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`opinion, however, the ’976 Patent shows that the inventors of the ’976 Patent had
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`possession of apparatuses, systems, and methods for “facilitating the implantation
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`of an artificial component in one of a hip joint, a knee joint, a hand and wrist joint,
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`an elbow joint, a shoulder joint, and a foot and ankle joint,” as recited in claims 1,
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`10, and 17 of the ’411 Patent.
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`33.
`
`Indeed, I note that the Examiner of the ’411 Patent concluded that the
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`’976 Patent fully disclosed all of the features claimed in the ’411 Patent, and in
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`particular the ’976 Patent fully disclosed an apparatus “for facilitating the
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`implantation of an artificial component in one of a hip joint, a knee joint, a hand
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`and wrist joint, an elbow joint, a shoulder joint, and a foot and ankle joint,” as
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`recited in claim 1 of the ’411 Patent. File History of the ’411 Patent (Ex. 1002) at
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`265 (Non-Final Office Action mailed April 5, 2000). I agree with this conclusion.
`
`As I have shown in Claim Chart attached to this Declaration as Appendix B, in my
`
`opinion the ’976 Patent’s original specification fully supports each of the elements
`
`of the ’411 Patent claims.
`
`34. The ’976 Patent’s original specification describes apparatuses and
`
`methods for surgeries involving a “patient’s joint.” ’976 Patent Original
`
`Specification (Ex. 2008) at 8:5–8. In my opinion, one of ordinary skill in the art
`
`would have known in February 1997 that a “patient’s joint” can include any of a
`
`hip joint, a knee joint, a hand and wrist joint, an elbow joint, a shoulder joint, and a
`
`foot and ankle joint. I further see that the ’976 Patent’s original specification
`
`describes total hip replacement (THR) surgery only after first describing surgical
`
`procedures on a “joint” in general. Id. at 12:4–16:36 (describing pre- and intra-
`
`operative processes involving a “joint”), 17:1–21:20 (describing the application of
`
`these processes specifically in a THR surgery). Accordingly, in my opinion, one
`
`of ordinary skill in the art would have appreciated that the description of the THR
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`surgery was representative of surgeries involving other joints of a patient,
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`including, e.g., a knee joint, a hand and wrist joint, an elbow joint, a shoulder joint,
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`and a foot and ankle joint.
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`35.
`
`In my opinion, one of ordinary skill in the art at the time of the filing
`
`of the ’976 Patent would have understood that “implantation of an artificial
`
`component” into a “hip joint” is representative of the class of orthopedic surgeries
`
`involving regions of the body that have “bony landmarks.” Surgeries involving
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`“implantation of an artificial component” into one of “a knee joint, a hand and
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`wrist joint, an elbow joint, a shoulder joint, and a foot and ankle joint” all are
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`included in this class of well-known surgeries that orthopedic surgeons had been
`
`conducting well before February 1997. In particular, one of ordinary skill in the
`
`art would have understood that, like a hip joint, a knee joint, a hand and wrist joint,
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`an elbow joint, a shoulder joint, and a foot and ankle joint can all be modelled
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`using a “rigid body model.” A rigid body model is a model in which the “body,”
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`i.e., the region involved in the surgery, can be displaced, but does not deform.
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`Because implantation surgeries into a hip joint, a knee joint, a hand and wrist joint,
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`an elbow joint, a shoulder joint, and a foot and ankle joint primarily involve
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`operations on rigid bones, a rigid body model can be used to model the joint.
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`Moreover, locations on a rigid bone can serve as “bony landmarks” that allow a
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`pre-operative plan and geometric model to be registered to the intra-operative
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`location of the patient, and allow the pre-operative plan and geometric model to be
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`updated during the surgery solely by tracking the location of the bony landmarks.
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`The shape of the bone, which is substantially more complicated to represent and
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`track than the location of the bone, does not have to be tracked during the surgery.
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`36.
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`Joints such as a hip joint, knee joint, a hand and wrist joint, an elbow
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`joint, a shoulder joint, and a foot and ankle joint stand in contrast to regions of the
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`body that primarily consist of soft tissue. For example, the heart consists primarily
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`of soft tissue and, as such, in the 1997 time frame it would not have been modelled
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`as a rigid body model. Instead, during heart surgery, the surgeon’s operations will
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`deform the heart, thus requiring tracking of both location and shape for a pre-
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`operative plan to be registered and updated during surgery. Other body parts that
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`consist primarily of soft tissue include the abdominal organs, such as the liver and
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`the kidney.
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`37. As I explain below, in my opinion, one of ordinary skill in the art at
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`the time of the filing of the ’976 Patent would have been able to apply the
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`techniques described in the ’976 Patent original specification and figures with
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`respect to joint implantation surgeries, and using the specific example of a hip
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`point implantation surgery, to implantation surgeries involving any of a knee joint,
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`a hand and wrist joint, an elbow joint, a shoulder joint, and a foot and ankle joint
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`without undue experimentation. Although each joint has a different geometry, one
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`of ordinary skill in the art would have been able to adapt the discussion of THR
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`surgery provided in the ’976 Patent Original Specification, Ex. 2008, at 17:1–21:20
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`to implantation surgeries involving any of a knee joint, a hand and wrist joint, an
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`elbow joint, a shoulder joint, and a foot and ankle joint. For example, the ’976
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`Patent original specification notes that CT scans could have been used to obtain
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`skeletal data regarding the hip joint. ’976 Patent Original Specification, Ex. 2008,
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`17:13–20. One of ordinary skill in the art would have understood that CT scans
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`could similarly have been used to obtain skeletal data for a knee joint, a hand and
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`wrist joint, an elbow joint, a shoulder joint, or a foot and ankle joint. A person of
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`ordinary skill in the art would also have understood how to use conventional
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`computer assisted design (CAD) modelling techniques to model both the implant
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`and any of a knee joint, a hand and wrist joint, an elbow joint, a shoulder joint, and
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`a foot and ankle joint. See ’976 Patent Original Specification, Ex. 2008, 17:21–25.
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`38. Moreover, the movement of each of a knee, a hand and wrist joint, an
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`elbow joint, a shoulder joint, or a foot and ankle joint was well understood by
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`February 1997. One of ordinary skill in the art would thus have been able to apply
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`the description of biomechanical simulation of the hip joint provided in the ’976
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`Patent original specification at 18:17–19:26 to simulate the movement of a knee
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`joint, a hand and wrist joint, an elbow joint, a shoulder joint, or a foot and ankle
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`joint as well. The ’976 Patent also describes attaching special light emitting diodes
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`(LEDs) to the patient and using a camera to detect light emitted by the LEDs. Id.,
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`11:27–32 (describing “targets 34” as special LEDs), 19:32–35 (describing
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`attaching targets 34 to the pelvic region of the hip joint). One of ordinary skill in
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`the art would have appreciated that LEDs could also have been attached to
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`locations on a knee joint, a hand and wrist joint, an elbow joint, a shoulder joint, or
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`a foot and ankle joint to track movement of the joint and facilitate registration.
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`Data from the LEDs could have been used to measure the near real time position of
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`the implant relative to the pre-operatively planned location. See id., 20:2–19.
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`Thus, in my opinion, based on the description in the ’976 Patent original
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`description, one of ordinary skill in the art would at the filing date of the ’976
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`Patent would have been able to make and use the subject matter recited in claims
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`1–17 of ’411 Patent. See Appendix B, infra.
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`VII. CITED REFERENCES
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`A. DiGioia
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`39. A.M. DiGioia et al., “HipNav: Pre-Operative Planning and Intra-
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`operative Navigational Guidance for Acetabular Implant Placement in Total Hip
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`Replacement Surgery,” 2nd CAOS Symposium, 1996 (“DiGioia”) (Ex. 1005) is a
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`conference paper that describes a system called the “HipNav System” or the
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`“HipNav Navigation,” which “allows a surgeon to determine optimal patient
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`specific acetabular implant placement and accurately achieve the desired
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`acetabular implant placement during surgery.” DiGioia, Abstract. Figure 3 of
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`DiGioia, which I have provided below, shows an overview of the system. As
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`shown in Figure 3, the HipNav system includes a pre-operative planner, a range of
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`motion simulator, and an intra-operative tracking and guidance system. Id. at 1–2.
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`The pre-oper