UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`SMITH & NEPHEW, INC.,
`Petitioner
`
`v.
`
`CONFORMIS, INC.
`Patent Owner
`
`IPR2017-00544
`U.S. Patent No. 7,534,263
`
`DECLARATION OF JAY D. MABREY, M.D.
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT 7,534,263
`
`Smith & Nephew Ex. 1002
`IPR Petition - USP 7,534,263
`
`
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`SMITH & NEPHEW, INC.,
`Petitioner
`
`v.
`
`CONFORMIS, INC.
`Patent Owner
`
`IPR2017-00544
`U.S. Patent No. 7,534,263
`
`DECLARATION OF JAY D. MABREY, M.D.
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT 7,534,263
`
`Smith & Nephew Ex. 1002
`IPR Petition - USP 7,534,263
`
`
`
`
`
`
`
`I, Jay D. Mabrey, M.D., do hereby declare:
`
`I am making this declaration at the request of Smith & Nephew, Inc.
`
`1.
`
`(“S&N”).
`
`2.
`
`I am being compensated for my work in this matter and I am being
`
`reimbursed at cost for any expenses. My compensation in no way depends upon
`
`the outcome of this proceeding.
`
`3.
`
`In preparing this Declaration, I considered the following materials:
`
`Exhibit No.
`
`Description
`
`1001
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`U.S. Patent No. 7,534,263 (“the ’263 patent”)
`
`PCT Publication No. WO 93/25157 (“Radermacher”)
`
`PCT Publication No. WO 00/35346 (“Alexander”)
`
`PCT Publication No. WO 00/59411 (“Fell”)
`
`U.S. Patent No. 6,712,856 (“Carignan”)
`
`PCT Publication No. WO 95/28688 (“Swaelens”)
`
`U.S. Patent No. 6,510,334 (“Schuster ’334”)
`
`U.S. Patent No. 5,098,383 (“Hemmy”)
`
`European Patent No. EP 0 908 836 (“Vomlehn”)
`
`U.S. Patent No. 4,502,483 (“Lacey”)
`
`U.S. Patent No. 6,575,980 (“Robie”)
`
`U.S. Patent No. 5,735,277 (“Schuster ’277”)
`
`-1-
`
`
`
`
`
`Exhibit No.
`
`1014
`
`1015
`
`1017
`
`1019
`
`1020
`
`1021
`
`1031
`
`1032
`
`1033
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`
`1040
`
`Description
`
`U.S. Patent No. 5,320,102 (“Paul”)
`
`J.B. Antoine Maintz & Max A. Viergever, A Survey of Medical
`Image Registration, 2 Med. Image Analysis 1 (1998) (“Maintz”)
`
`Excerpts of the ’263 Patent Prosecution History
`
`CV of Jay D. Mabrey, M.D.
`
`U.S. Patent No. 7,981,158 (“the ’158 patent”)
`
`U.S. Provisional Patent Application No. 60/293488 (filed May 25,
`2001) (“the ’488 application”)
`
`U.S. Patent No. 4,841,975 (“Woolson”)
`
`U.S. Patent No. 4,646,729 (“Kenna”)
`
`Klaus Radermacher et al., Computer Assisted Orthopaedic Surgery
`with Image Based Individual Templates, 354 Clinical Orthopaedics
`and Related Research 28 (1998) (“CAOS”)
`
`PCT Publication No. WO 01/66021 (“Pinczewski”)
`
`U.S. Publication No. 2004/0117015 (“Biscup”)
`
`U.S. Patent No. 4,759,350 (“Dunn”)
`
`Excerpts from Surgery of the Knee (John N. Insall et al., eds., 2d
`ed. 1993) (“Insall”)
`
`U.S. Patent No. 5,741,215 (“D’Urso”)
`
`U.S. Patent No. 4,436,684 (“White”)
`
`U.S. Patent No. 4,822,365 (“Walker”)
`
`-2-
`
`
`
`Description
`
`Excerpts from Dror Paley, Principles of Deformity Correction
`(2002) (“Principles of Deformity Correction”)
`
`U.S. Patent No. 5,107,824 (“Rogers”)
`
`U.S. Patent No. 5,370,692 (“Fink”)
`
`U.S. Patent No. 5,520,695 (“Luckman”)
`
`Hofmann et al., “Effect of the Tibial Cut on Subsidence Following
`Total Knee Arthroplasty,” Clinical Orthopaedics & Related
`Research, Aug. 1991. (“Hofmann”)
`
`U.S. Patent No. 4,474,177 (“Whiteside II”)
`
`PCT Publication No. WO 98/32384 (“Robie PCT”)
`
`U.S. Patent No. 5,630,820 (“Todd”)
`
`
`
`Exhibit No.
`
`1042
`
`1043
`
`1044
`
`1089
`
`1090
`
`1091
`
`1092
`
`1093
`
`
`
`-3-
`
`
`
`
`
`
`
`I. BACKGROUND AND QUALIFICATIONS
`A. Experience and Qualifications
`4.
`I am an orthopaedic surgeon by training and profession. My current
`
`CV is being submitted as Exhibit 1019.
`
`5.
`
`I received a B.A. in Biochemistry from Cornell University in 1977
`
`and an M.D. from Weill Cornell Medical College in 1981. I also received an
`
`M.B.A. from Texas Woman’s University in 2012.
`
`6.
`
`I served as an Intern in General Surgery in 1981, as a Resident in
`
`General Surgery in 1982, as a Resident in Orthopaedics from 1983 to 1986, and as
`
`Chief Resident in Orthopaedics in 1987, all at Duke University Medical Center in
`
`Durham, North Carolina. From 1987 to 1990 I served as a Major in the United
`
`States Army Medical Corps as an orthopaedic surgeon at Fort Stewart, Georgia. It
`
`was at Fort Stewart that I oversaw the orthopaedic care of the 24th Infantry
`
`Division (Mechanized) and the 1st of the 75th Ranger Battalion. I additionally
`
`completed a Fellowship in Biomechanics and Total Joints at the Hospital for
`
`Special Surgery in New York, New York, from 1990 to 1991.
`
`7.
`
`From 1991 to 1993 I served as a Major in the United States Army
`
`Medical Corps at Fort Sam Houston, Texas, now known as Joint Base San
`
`Antonio. There I was co-director of the total joint service. After completing my
`
`military service in 1993, I joined the faculty of the Department of Orthopaedics at
`
`-4-
`
`
`
`
`
`the University of Texas Health Science Center at San Antonio as an associate
`
`professor. I also directed the Total Joint Service at the Audie Murphy Veterans’
`
`Hospital in San Antonio. Additionally, I served as the Chairman of the Task Force
`
`on Virtual Reality for the American Academy of Orthopaedic Surgeons from 1996
`
`to 2006. This multimillion dollar project subsequently developed and produced a
`
`virtual reality surgical simulator for arthroscopic surgery of the knee. I rose to the
`
`rank of full professor and was actively engaged in the surgical education of several
`
`orthopaedic residents in training until 2004 when I was recruited to become the
`
`Chief of Orthopaedics at Baylor University Medical Center at Dallas.
`
`8.
`
`Since 2004, I have served as the Chief of the Department of
`
`Orthopaedics at Baylor University Medical Center in Dallas, Texas. Since 2012, I
`
`have also served as a Professor of Surgery at Texas A&M Health Science Center
`
`College of Medicine. A complete list of my academic appointments is included in
`
`my CV.
`
`9. My areas of expertise include orthopaedic surgery, including knee and
`
`hip replacement, medical device design, and computer assisted surgery. As
`
`described in my CV, I have extensive experience related to performing knee
`
`replacement surgeries, as well as designing medical devices for knee replacement
`
`surgery.
`
`-5-
`
`
`
`
`
`10.
`
`I have extensive industry experience consulting on the design of
`
`medical devices, including work for Exactech on computer assisted navigation
`
`systems and total knee replacements, for DePuy on Surgical Robotics, and for
`
`Howmedica and Smith & Nephew on Adult Reconstruction.
`
`11.
`
`I have also worked as a surgeon as part of my service in the United
`
`States Army Medical Corps. A complete list of my civilian and military
`
`experience is included in my CV.
`
`12.
`
`I received certifications from the National Board of Medical
`
`Examiners in 1982 and from the American Board of Orthopaedic Surgery in 1989.
`
`I was recertified by the American Board of Orthopaedic Surgery (Oral) in 1998
`
`and by the American Board of Orthopaedic Surgery (Computer) in 2010. I have
`
`served as an oral examiner for the American Board of Orthopaedic Surgery on
`
`several occasions. I have held a permanent license to practice medicine in Texas
`
`since 1992.
`
`13.
`
`I have authored or co-authored numerous peer-reviewed academic
`
`publications in the field of orthopaedic surgery, including several articles relating
`
`to knee arthroplasty. A list of my publications is included in my CV.
`
`14.
`
`I am a named co-inventor on U.S. Patent Nos. 8,414,653 and
`
`8,506,640, both of which are related to knee prosthesis systems.
`
`-6-
`
`
`
`
`
`15.
`
`I have served as a panelist on the FDA Orthopaedic Devices Panel
`
`from 2004 to 2006 and then served as the Panel’s Chairman from 2006 through
`
`2010.
`
`16. My current practice of orthopaedic surgery encompasses primary total
`
`hip and total knee replacement as well as complex revisions of failed hip and knee
`
`replacements.
`
` I employ computer navigation on all primary total knee
`
`replacements which allows me to align the knee components precisely with respect
`
`to the patient’s individual mechanical axis. I have recently begun to use computer
`
`based surgical navigation to align components in revision knee surgery as well.
`
`17.
`
`I routinely use computerized tomography and magnetic resonance
`
`imaging to aide in the revision of failed hip and knee replacements. I also have
`
`experience using computerized tomography to generate three-dimensional models
`
`of the bone of failed arthroplasties and have employed that data to produce custom
`
`implants for reconstruction surgery.
`
`18.
`
`I have personal experience and skill in the creation of three
`
`dimensional models using a variety of design programs including 3DS Max, Maya
`
`and Z-Brush. Additionally I have experience in producing three dimensional
`
`models on a Form 2 stereolithography printer.
`
`19.
`
`I was previously retained by Smith & Nephew to serve as an expert
`
`witness in an inter partes review proceeding for U.S. Patent. No. 7,806,896, which
`
`-7-
`
`
`
`
`
`related to methods of performing knee arthroplasty using a “customized cutting
`
`guide fabricated for the patient based on preoperative information.”
`
`B. Relevant Legal Standards
`20.
`I have been asked to provide my opinion as to whether the claims of
`
`the ’263 patent would have been obvious to a person of ordinary skill in the art at
`
`the time of the alleged invention, in view of the prior art.
`
`21.
`
`I am an orthopaedic surgeon by training and profession. The opinions
`
`I am expressing in this report involve the application of my training and technical
`
`knowledge and experience to the evaluation of certain prior art with respect to the
`
`’263 patent.
`
`22. Although I have been involved as a technical expert in patent matters
`
`before, I am not an expert in patent law. Therefore, the attorneys from Knobbe,
`
`Martens, Olson & Bear, LLP have provided me with guidance as to the applicable
`
`patent law in this matter. The paragraphs below express my understanding of how
`
`I must apply current principles related to patent validity to my analysis.
`
`23.
`
`It is my understanding that in determining whether a patent claim is
`
`obvious in view of the prior art, the Patent Office construes the claim by giving the
`
`claim its broadest reasonable interpretation consistent with the specification. For
`
`the purposes of this review, and to the extent necessary, I have construed each
`
`-8-
`
`
`
`
`
`claim term in accordance with its plain and ordinary meaning under the required
`
`broadest reasonable interpretation.
`
`24.
`
`It is my understanding that a claim is “obvious,” and therefore
`
`unpatentable, if the claimed subject matter as a whole would have been obvious to
`
`a person of ordinary skill in the art at the time of the alleged invention. I also
`
`understand that an obviousness analysis takes into account the scope and content of
`
`the prior art, the differences between the claimed subject matter and the prior art,
`
`and the level of ordinary skill in the art at the time of the invention.
`
`25.
`
`In determining the scope and content of the prior art, it is my
`
`understanding that a reference is considered appropriate prior art if it falls within
`
`the field of the inventor’s endeavor. In addition, a reference is prior art if it is
`
`reasonably pertinent to the particular problem with which the inventor was
`
`involved. A reference is reasonably pertinent if it logically would have
`
`commended itself to an inventor’s attention in considering his problem. If a
`
`reference relates to the same problem as the claimed invention, that supports use of
`
`the reference as prior art in an obviousness analysis.
`
`26. To assess the differences between prior art and the claimed subject
`
`matter, it is my understanding that the law requires the claimed invention to be
`
`considered as a whole. This “as a whole” assessment requires showing that one of
`
`ordinary skill in the art at the time of invention, confronted by the same problems
`
`-9-
`
`
`
`
`
`as the inventor and with no knowledge of the claimed invention, would have
`
`selected the elements from the prior art and combined them in the claimed manner.
`
`27.
`
`It is my further understanding that the law recognizes several
`
`rationales for combining references or modifying a reference to show obviousness
`
`of claimed subject matter. Some of these rationales include: combining prior art
`
`elements according to known methods to yield predictable results; simple
`
`substitution of one known element for another to obtain predictable results; a
`
`predictable use of prior art elements according to their established functions;
`
`applying a known technique to a known device (method or product) ready for
`
`improvement to yield predictable results; choosing from a finite number of
`
`identified, predictable solutions, with a reasonable expectation of success; and
`
`some teaching, suggestion, or motivation in the prior art that would have led one of
`
`ordinary skill to modify the prior art reference or to combine prior art reference
`
`teachings to arrive at the claimed invention.
`
`28.
`
`I also understand that an obviousness analysis must consider whether
`
`there are additional factors that would indicate that the invention would not have
`
`been obvious. These factors include whether there was: (i) a long-felt need in the
`
`industry; (ii) any unexpected results; (iii) skepticism of the invention; (iv) a
`
`teaching away from the invention; (v) commercial success; (vi) praise by others for
`
`the invention; and (vii) copying by other companies. I am not aware of any
`
`-10-
`
`
`
`
`
`evidence that would suggest that the claims of the ’263 patent would have been
`
`non-obvious.
`
`C.
`
`Person of Ordinary Skill in the Art
`29.
`
`It is my understanding that when interpreting the claims of the ’263
`
`patent, I must do so based on the perspective of one of ordinary skill in the art at
`
`the relevant priority date. As discussed below, for purposes of this declaration, I
`
`have assumed the priority date to be March 12, 2002; however, my opinion would
`
`not change even if the claims of the ’263 patent were entitled to the earliest
`
`claimed priority date of May 25, 2001.
`
`30. The ’263 patent describes methods of making well-known surgical
`
`tools, namely patient-specific cutting guides that may be used, for example, in knee
`
`arthroplasty. Based on my review of the specification and claims of the ’263
`
`patent, it is my opinion that one of ordinary skill in the art would be an orthopaedic
`
`surgeon having at least three years of experience performing knee arthroplasty
`
`surgeries. One of ordinary skill in the art could also include an engineer having a
`
`bachelor’s degree in biomedical engineering (or a closely related discipline) who
`
`works with surgeons in designing cutting guides and who has at least three years of
`
`experience learning from these doctors about the use of such devices in joint
`
`replacement surgeries.
`
`-11-
`
`
`
`
`
`31.
`
`I am able to make this assessment because in the 1980s and 1990s, I
`
`performed numerous surgeries (including knee arthroplasty) and worked with
`
`many surgeons. During the 1990s and later, I supervised and trained many
`
`surgeons in the field of orthopaedic surgery, particularly in total knee and total hip
`
`replacement. Not long after the relevant priority date, I became Chief of the
`
`Department of Orthopaedics at Baylor University Medical Center, where I now
`
`supervise and train resident surgeons in the field of orthopaedic surgery. The
`
`surgeons that I worked with during the 1990s had the requisite knowledge to, and
`
`did, make and use systems as described in the claims of the ’263 patent. Because I
`
`have worked with and supervised surgeons in the field of joint surgery, I know
`
`very well what their capabilities were in the 1990s and early 2000s, how those
`
`surgeons would interpret and understand the claims of the ’263 patent, and how
`
`they would understand the disclosures in the prior art discussed herein.
`
`32.
`
`In my opinion, as set forth in more detail below, a person having
`
`ordinary skill in the art at the time of the invention would have considered the
`
`methods claimed in the ’263 patent to be obvious in view of the prior art.
`
`II. BACKGROUND OF THE TECHNOLOGY
`33. The claims of the ’263 patent relate to methods of making surgical
`
`tools for the repair of articular joint surfaces, such as the knee.
`
`-12-
`
`
`
`
`
`34. Knee replacement surgery is also known as knee arthroplasty.
`
`Generally, there are two types of knee replacement surgeries: total knee and partial
`
`knee replacement. During either type of knee replacement, an orthopaedic surgeon
`
`replaces either a portion of or all of a damaged knee with an artificial device (also
`
`known as a “prosthesis” or an “implant”). Although total knee arthroplasty
`
`(“TKA”) is the most common procedure, some people can benefit from replacing
`
`only a portion of the knee. This partial replacement is sometimes called a
`
`unicondylar knee arthroplasty (“UKA”).
`
`35. Knee replacement was not new when the patent was filed. Indeed,
`
`surgeons had been performing knee replacement surgeries for decades prior to the
`
`priority date of the ’263 patent.
`
`-13-
`
`
`
`
`
`A. Knee Anatomy
`36. The knee is a major weight-bearing joint that is held together by
`
`muscles, ligaments, and soft tissue. Cartilage inside the joint provides a low-
`
`friction surface that facilitates shock absorption and lubrication, which allows a
`
`person to walk, run, lift, climb stairs, etc. and so on. The illustration below shows
`
`the components of the knee relevant to the ’263 patent, namely the bones and the
`
`articular cartilage:
`
`
`
`
`
`
`
`In a healthy knee, the lower end of the femur and the upper end of the tibia are
`
`covered by articular cartilage. The layer of bone directly beneath the articular
`
`-14-
`
`
`
`
`
`cartilage is called “subchondral bone.” In arthritic joints, some of the articular
`
`cartilage is often worn or torn away, resulting in a surface that is partially articular
`
`cartilage and partially exposed subchondral bone.
`
`B. Knee Alignment
`37. The femur and the tibia each has a mechanical and anatomic axis, as
`
`shown below:
`
`
`
`-15-
`
`
`
`
`
`Ex. 1042 at Fig. 1-3 a-d (illustrating an anatomic axis as an axis that extends along
`
`the center of the bone); Ex. 1043 at 1:37-48, Fig. 1.
`
`38. Principles of Deformity Correction accurately describes
`
`the
`
`mechanical and anatomic bone axes as follows:
`
`The mechanical axis of a bone is defined as the straight line
`connecting the joint center points of the proximal and distal joints.
`The anatomic axis of a bone is the mid-diaphyseal line. The
`mechanical axis is always a straight line connecting two joint center
`points, whether in the frontal or sagittal plane. The anatomic axis line
`may be straight in the frontal plane but curved in the sagittal plane, as
`in the femur. . . . In the tibia, the anatomic axis is straight in both
`frontal and sagittal planes [].
`
`
`Ex. 1042 at 1-2.
`
`C. Knee Replacement Surgery
`39. When a knee has been damaged by a disease like osteoarthritis, knee
`
`replacement surgery can replace the damaged portions with artificial components.
`
`Before the surgeon can begin the procedure, however, the parts of the knee to be
`
`replaced must be exposed. A surgeon will expose the operative areas by first
`
`making an incision through the patient’s skin. The surgeon will then typically
`
`access the operative area by moving the patella out of way to expose the end of the
`
`femur.
`
`40. To prepare the bone to receive an implant, the surgeon typically
`
`removes a small amount of underlying bone and shapes the bone to receive the
`
`-16-
`
`
`
`
`
`implant. For example, the images below show the cuts that a surgeon might make
`
`to prepare the end of a femur:
`
`
`
`Ex. 1011 at Figs. 16 (annotated) & 17. These cuts provide flat bone surfaces onto
`
`which an implant component can be seated, as well as holes into which pegs on the
`
`implant can be placed. The inner surface of the implant typically has a
`
`corresponding geometry and two pegs that fit into the holes to secure the implant
`
`in the proper location. In many cases, this is still how the femur is prepared for an
`
`implant in TKA.
`
`41. To help ensure that cuts and drill holes are made accurately, rather
`
`than cutting free-handed, surgeons typically use cutting guides with a guide surface
`
`that guides the saw used to cut (or “resect”) the bone. Cutting guides, also known
`
`-17-
`
`
`
`
`
`as resection guides or guide members, come in many different shapes and sizes and
`
`have been long known in the art. A prior art cutting guide with cutting apertures
`
`similar to those shown in the ’263 patent is shown below (coloring and annotations
`
`added):
`
`
`
`
`
`’263 Patent (Ex. 1001)
`
`Robie (Ex. 1012)
`
`42.
`
` As shown above, in some cutting guides, the guide is an aperture, slit
`
`or slot for guiding a saw. In other cutting guides, the guide is simply a surface
`
`against which the saw can be placed. As discussed below, some cutting guides
`
`have both types of guides. Whether a slot or a surface is used is a matter of
`
`surgeon preference. In fact, many cutting guides were available in two formats:
`
`one with slots, the other with cutting surfaces. Some surgeons prefer cutting
`
`guides with slots, which provide greater guidance of the saw blade, while others
`
`prefer open cutting surfaces because they make it easier for the surgeon to adjust
`
`-18-
`
`
`
`
`
`the cut. Both were commonly used and would have been known to a person of
`
`ordinary skill in the art, and a person of ordinary skill in the art would further have
`
`known that slots and open cutting surfaces were generally interchangeable.
`
`D.
`
`
`
`Summary of Patient-Specific Guides
`i.
`
`Using MRI and/or CT to Image Joint Surfaces.
`
`43. Using various imaging techniques, including MRI and CT scans, to
`
`determine the size, shape, curvature, or contour of a patient’s joint surface was
`
`well known to those of ordinary skill in the art in the 1990s. The ’263 patent states
`
`that the alleged invention employs “conventional” methods of x-ray, ultrasound,
`
`CT, and MRI that are “within the skill of the art” and are “explained fully in the
`
`literature”:
`
`[T]he practice of the present invention employs, unless otherwise
`indicated, conventional methods of x-ray imaging and processing, x-
`ray tomosynthesis, ultrasound including A-scan, B-scan and C-scan,
`computed tomography (CT scan), magnetic resonance imaging
`(MRI), optical coherence tomography, single photon emission
`tomography (SPECT) and positron emission tomography (PET)
`within the skill of the art. Such techniques are explained fully in the
`literature and need not be described herein. See, e.g., X-Ray Structure
`Determination: A Practical Guide, 2nd Edition, editors Stout and
`Jensen, 1989, John Wiley & Sons, publisher; Body CT: A Practical
`Approach, editor Slone, 1999, McGraw-Hill publisher; X-ray
`Diagnosis: A Physician's Approach, editor Lam, 1998 Springer-
`Verlag, publisher; and Dental Radiology: Understanding the X-Ray
`Image, editor Laetitia Brocklebank 1997, Oxford University Press
`publisher.
`
`
`-19-
`
`
`
`
`
`Ex. 1001 at 3:52-4:1; see also id. at 10:49-12:10. “Conventional” imaging
`
`techniques, such as MRI, were known to be capable of measuring the size, shape,
`
`thickness, curvature, and/or contour of joint surfaces, including cartilage surfaces,
`
`prior to 2002. A continuation-in-part of the ’263 patent, U.S. Patent No.
`
`7,981,158, admits that “imaging techniques suitable for measuring thickness and/or
`
`curvature (e.g., of cartilage and/or bone) or size of areas of diseased cartilage or
`
`cartilage loss” were known in the art, and included MRI and CT scans. Ex. 1020 at
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`32:1-16. Prior to 2002, I routinely obtained this type of information from CT and
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`MRI images of my patient’s knee and hip joints. By 2002, imaging a patient’s
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`cartilage surface and/or underlying subchondral bone was commonplace.
`
`44. As just one example, and as is discussed in more detail below,
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`Alexander, which published in 2000, recognized that:
`
`In obtaining an image of the cartilage of a joint in a mammal, a
`number of internal imaging techniques in the art are useful for
`electronically generating a cartilage image. These include magnetic
`resonance imaging (MRI), computed tomography scanning (CT, also
`known as computerized axial tomography or CAT), and ultrasound
`imaging techniques. Others may be apparent to one of skill in the art.
`MRI techniques are preferred.
`
`
`-20-
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`
`
`
`
`Ex. 1004 at 14. As shown below, Alexander disclosed that MRI could be used to
`
`create a three-dimensional model of a patient’s knee joint, including both bone and
`
`cartilage surfaces:
`
`
`
`Ex. 1004 at Fig. 18C (cropped); see also id. at 2-3, 14-15, Figs. 18-19. Alexander
`
`also disclosed generating a cartilage map that provides the size, shape, and
`
`curvature of the patient’s articular cartilage:
`
`-21-
`
`
`
`
`
`
`
`Alexander (Ex. 1004) at Fig. 19
`
`
`
`45. Several other prior art references similarly confirm that MRI could be
`
`used to image the size, shape, curvature, thickness, or contour of cartilage. See,
`
`e.g., Ex. 1013 at 2:8-17 (nuclear magnetic resonance tomography (MRI) “makes
`
`possible an especially sharp definition of the joint contour by representing the
`
`cartilaginous tissue and other soft parts of the damaged knee joints”); see generally
`
`Ex. 1014 (articular cartilage shape and thickness can be determined using MRI);
`
`Ex. 1005 at 22:6-9 (“From the MRI images obtained, contour radii plots and
`
`surface descriptions of the femoral condyle and tibial plateau of the affected area,
`
`complete with articular cartilage, are generated and analyzed . . . .”).
`
`46. The prior art also confirms that MRI and CT scans could be used to
`
`obtain the geometry of a bone surface, including the subchondral bone surface.
`
`Ex. 1004 at 14 (MRI can be used to “evaluate the subchondral bone for signal
`
`abnormalities”), 26 (software allows user to assess “the bones of the joint” and
`
`-22-
`
`
`
`
`
`generate a representation of the “femur” and “tibia” in addition to the femoral and
`
`tibial cartilage), 39 (“Procedures similar to those discussed hereinbefore for
`
`cartilage may be used, but modified for application to bone images.”); Figs. 10A-
`
`C, 12A-B; Ex. 1006 at 9:1-6 (CT scan used to provide a three-dimensional contour
`
`of the femur).
`
`ii.
`
`Using Imaging to Align a Surgical Tool Guide
`
`47.
`
`Initially, surgeons positioned cutting guides by hand. Beginning in
`
`the 1960s and 1970s, surgeons started using mechanical alignment guides to assure
`
`that cutting guides were properly aligned with the leg when placed on the bone.
`
`Two common types of alignment guides are intramedullary alignment rods, which
`
`are inserted into the medullary canal (bone marrow cavity) of the bone and
`
`extramedullary alignment rods, which are placed externally along the medullary
`
`canal of the bone. For example, an alignment guide 40 for the femur is illustrated
`
`below. The alignment guide 40 is oriented relative to an anatomical axis (the axis
`
`of the femur), and a femoral cutting guide 65 and the resulting femoral cut are
`
`further oriented relative to the alignment guide 40 so that the femoral cutting guide
`
`65 is relative to (i.e., perpendicular to) the axis. Ex. 1036 at 10:62-11:11.
`
`-23-
`
`
`
`
`
`
`
`
`
`
`
`Ex. 1036, Figs. 4, 7-9 (illustrating that the femoral cutting guide 65 is aligned
`
`using the alignment guide 40).
`
`48. By the 1990s, it was widely known that x-rays, MRI, and CT scans of
`
`the patient’s knee joint could be used to align cutting guides on the bone and/or
`
`cartilage surface.
`
`
`
`-24-
`
`
`
`
`
`E. Using Imaging to Create Patient-Specific Surgical Tools
`49.
`In the 1990s, it was widely known that patient-specific cutting guides
`
`could be created based on MRI and/or CT data regarding the size, shape, and
`
`curvature of a patient’s knee joint. As discussed in more detail below,
`
`Radermacher disclosed such a cutting guide in 1993. Radermacher described
`
`using MRI and/or CT data to create an “individual template” (shown below) for
`
`guiding surgical tools, where the individual template includes “contact faces” that
`
`are a “copy” or “negative” of a the “natural (i.e. not pre-treated) surface” of a
`
`patient’s joint. Ex. 1003 at 12.
`
`
`
`-25-
`
`
`
`
`
`
`
`50.
`
`In 1995, Swaelens also disclosed a patient-specific cutting guide.
`
`Swaelens described obtaining MRI images of a patient’s knee joint, creating a
`
`digital model, adding “functional elements” such as cutting slots or drill holes to
`
`the digital model to create a “perfected model” that “can be placed as a template on
`
`the bone of the patient 1 during surgery and which fits perfectly to it.” Ex. 1007 at
`
`6:24-29, 9:1-13, 10:23-30, 13:17-25, Fig. 6.
`
`-26-
`
`
`
`
`
`
`
`51. Swaelens further explained that the method accounts for “grey value
`
`data” such as muscles, tendons, nerves, etc. account when designing the patient-
`
`specific device. Id. at 2:12-23, 4:16-17. A person of ordinary skill in the art would
`
`understand that grey value data includes data regarding articular cartilage.
`
`52. Another patent application for a patient-specific cutting guide was
`
`filed by Schuster in 2000. Schuster described using CT or “nuclear spin resonance
`
`tomography” to create a patient-specific “implantation aid.” Ex. 1008, 2:59-64,
`
`3:50-57. Nuclear spin tomography is old terminology for what is now referred to
`
`as MRI. See Ex. 1015 at 1. Schuster’s implantation aids (5, 6) were “caps” for
`
`“enveloping” the area to be severed and contained guides (7, 8) for guiding a saw,
`
`as shown below. Ex. 1008 at 3:50-4:5, 4:35-38, 5:20-27.
`
`-27-
`
`
`
`
`
`
`
`53. As described in more detail below, in 2000, Fell also disclosed using
`
`MRI to determine the contour of the femoral and tibial surfaces, including the
`
`articular cartilage. Ex. 1005 at 14:13-19, 15:12-21, 22:6-9. Fell disclosed using
`
`this data to create a patient-specific meniscus implant. Id. at 20:30-21:3.
`
`54.
`
`It was also widely known in the 1990s that patient-specific cutting
`
`guides could match the size, shape and curvature of a patient’s bone, including
`
`subchondral bone. For example, in 1992, Hemmy disclosed using CT scans or
`
`MRI to create three-dimensional reconstructions of a patient’s tissue geometry.
`
`Ex. 1009 at 2:11-25, 4:14-21. Hemmy disclosed using such data to create a
`
`“positioning means” that included a surface that matched the patient’s tissue so
`
`that the device could be placed in a fixed location. Id. at 2:47-3:2, 5:59-6:45.
`
`-28-
`
`
`
`
`
`Hemmy taught that an orienting means (tool guide), such as a “slit” to guide a saw,
`
`could be attached to the positioning means. Id. at 7:8-32.
`
`55.
`
`In 1999, Vomlehn also disclosed using CT or MRI data to create a
`
`patient-specific device. Ex. 1010 at 2:48-55. Vomlehn’s device 30 had “a mating
`
`surface 34, designed to fit flush against the surface of the solid structure” such as a
`
`bone. Id. at 3:38-45.
`
`
`
`56.
`
`In 2000, Carignan et al. filed a patent application for a patient-specific
`
`template shown below that includes “holes or slots 306” and an inner surface 302
`
`that is custom-formed based on CT data to match the surface of a particular
`
`patient’s femur. Ex. 1006 at 7:53-9:23.
`
`-29-
`
`
`
`
`
`
`
`57. As can be seen from this brief summary, (a) obtaining image data
`
`associated with a joint and deriving the cartilage surface to create (b) a patient-
`
`specific surgical tool with a surface that is substantially a negative of the cartilage
`
`surface with (c) guides having predetermined positions, shapes, and/or orientations
`
`were widely known in the prior art. Some of these references are described in
`
`more detail below, but they should be viewed in the context of the state of the art,
`
`-30-
`
`as discussed above.
`
`
`
`
`
`
`
`
`
`F. Using Joint Axes to Determine Cutting or Drilling Planes
`58. To ensure the proper orientation of a knee implant, surgeons typically
`
`identify an axis of the joint using X-ray imaging, CT imaging, topograms, or MRI,
`
`and the guides are aligned to an axis of the joint. Exs. 1036 (X-ray), 1031 (CT),
`
`1003 (MRI, CT), 1033 (topograms). As illustrated below, surgeons typically use
`
`the mechanical (or biomechanical) axis, which is the axis of alignment of the leg.
`
`Exs. 1036, 1031.
`
`
`
` Dunn (Ex. 1036)
`
` Woolson (Ex. 1031) (annotated)
`
`-31-
`
`
`
`
`
`Ex. 1036, Fig. 1 (illustrating mechanical axis, which extends from the center of the
`
`femoral head at the hip, between the condylar surfaces at the center of the knee,
`
`and through the ankle joint); Ex. 1031, Fig. 1 (illustrating that the cut line 20 is
`
`perpendicular
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