UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________________________
`
`SMITH & NEPHEW, INC.,
`Petitioner,
`
`v.
`
`CONFORMIS, INC.,
`Patent Owner.
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`Case No. IPR2017-00488
`U.S. Patent No. 9,295,482
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`DECLARATION OF JAY D. MABREY, M.D.
`IN SUPPORT OF PETITION FOR INTER PARTES REVIEW OF
`CLAIMS 13-20 OF U.S. PATENT NO. 9,295,482
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`Smith & Nephew Ex. 1102
`IPR Petition - USP 9,295,482
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`I, Jay D. Mabrey, M.D., do hereby declare:
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`I am making this declaration at the request of Smith & Nephew, Inc.
`
`1.
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`(“Smith & Nephew”).
`
`2.
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`I am being compensated for my work in this matter and I am being
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`reimbursed at cost for any expenses. My compensation in no way depends upon
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`the outcome of this proceeding.
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`3.
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`In preparing this Declaration, I considered the following materials:
`
`Exhibit No.
`
`Description
`
`1001
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
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`1012
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`1013
`
`U.S. Patent No. 9,295,482 (“the ’482 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 II”)
`
`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”)
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`U.S. Patent No. 5,735,277 (“Schuster ’277”)
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`-1-
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`
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`Exhibit No.
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`Description
`
`1014
`
`U.S. Patent No. 5,320,102 (“Paul”)
`
`1015
`
`1016
`
`1017
`
`1019
`
`1021
`
`1022
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`1031
`
`1032
`
`1034
`
`1035
`
`J.B. Antoine Maintz & Max A. Viergever, A Survey of Medical
`Image Registration, 2 Med. Image Analysis 1 (1998) (“Maintz”)
`
`PCT Publication No. WO 02/22014 (“WO ’014”)
`
`Excerpts of the ’482 Patent Prosecution History
`
`CV of Jay D. Mabrey, M.D.
`
`U.S. Provisional Patent Application No. 60/293488 (filed May 25,
`2001) (“the ’488 application”)
`
`U.S. Provisional Patent Application No. 60/363527 (filed March
`12, 2002) (“the ’527 application”)
`
`U.S. Provisional Patent Application No. 60/380692 (filed May 14,
`2002) (“the ’692 application”)
`
`U.S. Provisional Patent Application No. 60/380695 (filed May 14,
`2002) (“the ’695 application”)
`
`U.S. Patent Application No. 10/160667 (filed May 28, 2002) (“the
`’667 application”)
`
`U.S. Patent No. 7,468,075 (“the ’075 patent”)
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`U.S. Patent No. 7,618,451 (“the ’451 patent”)
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`U.S. Patent No. 4,841,975 (“Woolson”)
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`U.S. Patent No. 4,646,729 (“Kenna”)
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`International Publication No. WO 01/66021 (“Pinczewski”)
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`U.S. Publication No. 2004/0117015 (“Biscup”)
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`Exhibit No.
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`Description
`
`1036
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`U.S. Patent No. 4,759,350 (“Dunn”)
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`1037
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`1038
`
`1039
`
`1040
`
`1044
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`1045
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`1046
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`1047
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`1066
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`1067
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`1068
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`1069
`
`1070
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`Excerpts from Surgery of the Knee (John N. Insall et al., eds., 2d
`ed. 1993) (“Insall”)
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`U.S. Patent No. 5,741,215 (“D’Urso”)
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`U.S. Patent No. 4,436,684 (“White”)
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`U.S. Patent No. 4,822,365 (“Walker”)
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`U.S. Patent No. 5,370,692 (“Fink”)
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`Declaration of Christine Drake re: Translation of EP 1,074,229 A2
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`English Translation of EP 1,074,229 A2 (“Schuster I”)
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`European Patent Application No. 1,074,229 A2
`
`Felix Fernandez-Madrid et al., MR Features of Osteoarthritis of
`the Knee, 12 Magnetic Resonance Imaging 703-09 (1994)
`(“Fernandez-Madrid”)
`
`C-J. Menkes et al., Are Osteophytes Good or Bad?, 12
`OsteoArthritis and Cartilage S53-S54 (2004) (“Menkes”)
`
`C. G. Peterfy et al., Whole-Organ Magnetic Resonance Imaging
`Score (WORMS) of the Knee in Osteoarthritis, 12 OsteoArthritis
`and Cartilage 177-90 (2004) (“Peterfy”)
`
`Excerpts from Jarrold H. Mink et al., Magnetic Resonance
`Imaging of the Knee (1987)
`
`U.S. Provisional Patent Application No. 60/416601 (Filed on
`October 7, 2002) (“the ’601 application”)
`
`1071
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`U.S. Publication 2004/0133276 (“Lang”)
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`Exhibit No.
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`Description
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`1072
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`1073
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`1074
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`1075
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`1076
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`1077
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`1078
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`1079
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`1080
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`U.S. Patent No. 7,534,263 (“Burdulis Jr.”)
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`U.S. Patent No. 7,634,119 (“Tsougarakis”)
`
`U.S. Provisional Patent Application No. 60/894744 (Filed
`February 6, 2007) (“the ’744 application”)
`
`U.S. Provisional Patent Application No. 60/975028 (Filed on
`March 14, 2007) (“the ’028 application”)
`
`U.S. Provisional Patent Application No. 60/765592 (Filed on
`February 6, 2006) (“the ’592 application”)
`
`U.S. Provisional Patent Application No. 60/785168 (Filed on
`March 2006) (“the ’168 application”)
`
`U.S. Provisional Patent Application No. 60/788339 (Filed on
`March 31, 2006) (“the ’339 application”)
`
`U.S. Provisional Patent Application No. 60/431176 (The
`December 4, 2002) (“the ’176 application”)
`
`U.S. Provisional Patent Application No. 60/467686 (Filed on May
`2, 2003) (“the ’686 application”)
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`
`
`I.
`BACKGROUND AND QUALIFICATIONS
`A. Experience and Qualifications
`4.
`I am an orthopaedic surgeon by training and profession. My current
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`CV is being submitted as Exhibit 1019.
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`5.
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`I received a B.A. in Biochemistry from Cornell University in 1977
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`and an M.D. from Weill Cornell Medical College in 1981. I also received an
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`M.B.A. from Texas Woman’s University in 2012.
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`6.
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`I served as an Intern in General Surgery in 1981, as a Resident in
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`General Surgery in 1982, as a Resident in Orthopaedics from 1983 to 1986, and as
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`Chief Resident in Orthopaedics in 1987, all at Duke University Medical Center in
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`Durham, North Carolina. From 1987 to 1990 I served as a Major in the United
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`States Army Medical Corps as an orthopaedic surgeon at Fort Stewart, Georgia. It
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`was at Fort Stewart that I oversaw the orthopaedic care of the 24th Infantry
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`Division (Mechanized) and the 1st of the 75th Ranger Battalion. I additionally
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`completed a Fellowship in Biomechanics and Total Joints at the Hospital for
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`Special Surgery in New York, New York, from 1990 to 1991.
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`7.
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`From 1991 to 1993 I served as a Major in the United States Army
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`Medical Corps at Fort Sam Houston, Texas, now known as Joint Base San
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`Antonio. There I was co-director of the Total Joint service. After completing my
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`military service in 1993, I joined the faculty of the Department of Orthopaedics at
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`the University of Texas Health Science Center at San Antonio as an associate
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`professor. I also directed the Total Joint Service at the Audie Murphy Veterans’
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`Hospital in San Antonio. Additionally, I served as the Chairman of the Task Force
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`on Virtual Reality for the American Academy of Orthopaedic Surgeons from 1996
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`to 2006. This multimillion dollar project subsequently developed and produced a
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`virtual reality surgical simulator for arthroscopic surgery of the knee. I rose to the
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`rank of full professor and was actively engaged in the surgical education of several
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`orthopaedic residents in training until 2004 when I was recruited to become the
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`Chief of Orthopaedics at Baylor University Medical Center at Dallas.
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`8.
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`Since 2004, I have served as the Chief of the Department of
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`Orthopaedics at Baylor University Medical Center in Dallas, Texas. Since 2012, I
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`have also served as a Professor of Surgery at Texas A&M Health Science Center
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`College of Medicine. A complete list of my academic appointments is included in
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`my CV.
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`9. My areas of expertise include orthopedic surgery, including knee and
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`hip replacement, medical device design, and computer assisted surgery. As
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`described in my CV, I have extensive experience related to performing knee
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`replacement surgeries, as well as designing medical devices for knee replacement
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`surgery.
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`10.
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`I have extensive industry experience consulting on the design of
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`medical devices, including work for Exactech on computer assisted navigation
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`systems and total knee replacements, for DePuy on Surgical Robotics, and for
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`Howmedica and Smith & Nephew on Adult Reconstruction.
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`11.
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`I have also worked as a surgeon as part of my service in the United
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`States Army Medical Corps. A complete list of my civilian and military
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`experience is included in my CV.
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`12.
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`I received certifications from the National Board of Medical
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`Examiners in 1982 and from the American Board of Orthopaedic Surgery in 1989.
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`I was recertified by the American Board of Orthopaedic Surgery (Oral) in 1998
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`and by the American Board of Orthopaedic Surgery (Computer) in 2010. I have
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`served as an oral examiner for the American Board of Orthopaedic Surgery on
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`several occasions. I have held a permanent license to practice medicine in Texas
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`since 1992.
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`13.
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`I have authored or co-authored numerous peer-reviewed academic
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`publications in the field of orthopaedic surgery, including several articles relating
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`to knee arthroplasty. A list of my publications is included in my CV.
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`14.
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`I am a named co-inventor on U.S. Patent Nos. 8,414,653 and
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`8,506,640, both of which are related to knee prosthesis systems.
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`15.
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`I have served as a panelist on the FDA Orthopaedic Devices Panel
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`from 2004 to 2006 and then served as the Panel’s Chairman from 2006 through
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`2010.
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`16. My current practice of orthopaedic surgery encompasses primary total
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`hip and total knee replacement as well as complex revisions of failed hip and knee
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`replacements.
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` I employ computer navigation on all primary total knee
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`replacements which allows me to align the knee components precisely with respect
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`to the patient’s individual mechanical axis. I have recently begun to use computer
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`based surgical navigation to align components in revision knee surgery as well.
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`17.
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`I routinely use computed tomography and magnetic resonance
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`imaging to aide in the revision of failed hip and knee replacements. I also have
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`experience using computed tomography to generate three-dimensional models of
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`the bone of failed arthroplasties and have employed that data to produce custom
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`implants for reconstruction surgery.
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`18.
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`I have personal experience and skill in the creation of three
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`dimensional models using a variety of design programs including 3DS Max, Maya
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`and Z-Brush. Additionally I have experience in producing three dimensional
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`models on a Form 2 stereolithography printer.
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`19.
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`I was previously retained by Smith & Nephew to serve as an expert
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`witness in inter partes review proceedings for U.S. Patent No. 7,806,896, which
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`related to methods of performing knee arthroplasty using a “customized cutting
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`guide fabricated for the patient based on preoperative information,” and for several
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`related ConforMIS patents.
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`B. Relevant Legal Standards
`20.
`I have been asked to provide my opinion as to whether the claims of
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`the ’482 patent would have been obvious to a person of ordinary skill in the art at
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`the time of the alleged invention, in view of the prior art.
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`21.
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`I am an orthopaedic surgeon by training and profession. The opinions
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`I am expressing in this report involve the application of my training and technical
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`knowledge and experience to the evaluation of certain prior art with respect to the
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`’482 patent.
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`22. Although I have been involved as a technical expert in patent matters
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`before, I am not an expert in patent law. Therefore, the attorneys from Knobbe,
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`Martens, Olson & Bear, LLP have provided me with guidance as to the applicable
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`patent law in this matter. The paragraphs below express my understanding of how I
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`must apply current principles related to patent validity to my analysis.
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`23.
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`It is my understanding that in determining whether a patent claim is
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`obvious in view of the prior art, the Patent Office construes the claim by giving the
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`claim its broadest reasonable interpretation consistent with the specification. For
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`the purposes of this review, and to the extent necessary, I have construed each
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`claim term in accordance with its plain and ordinary meaning under the required
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`broadest reasonable interpretation.
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`24.
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`It is my understanding that a claim is “obvious,” and therefore
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`unpatentable, if the claimed subject matter as a whole would have been obvious to
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`a person of ordinary skill in the art at the time of the alleged invention. I also
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`understand that an obviousness analysis takes into account the scope and content of
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`the prior art, the differences between the claimed subject matter and the prior art,
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`and the level of ordinary skill in the art at the time of the invention.
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`25.
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`In determining the scope and content of the prior art, it is my
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`understanding that a reference is considered appropriate prior art if it falls within
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`the field of the inventor’s endeavor. In addition, a reference is prior art if it is
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`reasonably pertinent to the particular problem with which the inventor was
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`involved. A reference is reasonably pertinent if it logically would have
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`commended itself to an inventor’s attention in considering his problem. If a
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`reference relates to the same problem as the claimed invention, that supports use of
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`the reference as prior art in an obviousness analysis.
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`26. To assess the differences between prior art and the claimed subject
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`matter, it is my understanding that the law requires the claimed invention to be
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`considered as a whole. This “as a whole” assessment requires showing that one of
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`ordinary skill in the art at the time of invention, confronted by the same problems
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`as the inventor and with no knowledge of the claimed invention, would have
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`selected the elements from the prior art and combined them in the claimed manner.
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`27.
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`It is my further understanding that the law recognizes several
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`rationales for combining references or modifying a reference to show obviousness
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`of claimed subject matter. Some of these rationales include: combining prior art
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`elements according to known methods to yield predictable results; simple
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`substitution of one known element for another to obtain predictable results; a
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`predictable use of prior art elements according to their established functions;
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`applying a known technique to a known device (method or product) ready for
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`improvement to yield predictable results; choosing from a finite number of
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`identified, predictable solutions, with a reasonable expectation of success; and
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`some teaching, suggestion, or motivation in the prior art that would have led one of
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`ordinary skill to modify the prior art reference or to combine prior art reference
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`teachings to arrive at the claimed invention.
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`28.
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`I also understand that an obviousness analysis must consider whether
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`there are additional factors that would indicate that the invention would not have
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`been obvious. These factors include whether there was: (i) a long-felt need in the
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`industry; (ii) any unexpected results; (iii) skepticism of the invention; (iv) a
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`teaching away from the invention; (v) commercial success; (vi) praise by others for
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`the invention; and (vii) copying by other companies. I am not aware of any
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`evidence that would suggest that the claims of the ’482 patent would have been
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`non-obvious.
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`C.
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`Person of Ordinary Skill in the Art
`29.
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`It is my understanding that when interpreting the claims of the ’482
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`patent, I must do so based on the perspective of one of ordinary skill in the art at
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`the relevant priority date. As discussed below, I understand the relevant priority
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`date to be no earlier than March 23, 2006; however, my opinion would not change
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`even if the claims of the ’482 patent were entitled to the earliest claimed priority
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`date of May 25, 2001.
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`30. The ’482 patent describes the use of a surgical system, including an
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`implant and well-known surgical tools, namely patient-specific cutting guides that
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`may be used, for example, in knee arthroplasty. Based on my review of the
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`specification and claims of the ’482 patent, it is my opinion that one of ordinary
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`skill in the art would be an orthopaedic surgeon having at least three years of
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`experience performing knee arthroplasty surgeries. One of ordinary skill in the art
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`could also include an engineer having a bachelor’s degree in biomedical
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`engineering (or a closely related discipline) who works with surgeons in designing
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`implants and cutting guides and who has at least three years of experience learning
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`from these doctors about the use of such devices in joint replacement surgeries.
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`31.
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`I am able to make this assessment because in the 1980s and 1990s, I
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`performed numerous surgeries (including knee arthroplasty) and worked with
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`many surgeons. During the 1990s and later, I supervised and trained many
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`surgeons in the field of orthopaedic surgery, particularly in total knee and total hip
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`replacement. Not long after the relevant priority date, I became Chief of the
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`Department of Orthopaedics at Baylor University Medical Center, where I now
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`supervise and train resident surgeons in the field of orthopaedic surgery. The
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`surgeons that I worked with during the 1990s had the requisite knowledge to, and
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`did, make and use systems as described in the claims of the ’482 patent. Because I
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`have worked with and supervised surgeons in the field of joint surgery, I know
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`very well what their capabilities were in the 1990s and early 2000s, how those
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`surgeons would interpret and understand the claims of the ’482 patent, and how
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`they would understand the disclosures in the prior art discussed herein.
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`32.
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`In my opinion, as set forth in more detail below, a person having
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`ordinary skill in the art at the time of the invention would have considered the
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`devices claimed in the ’482 patent to be obvious in view of the prior art.
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`II. BACKGROUND OF THE TECHNOLOGY
`33. The claims of the ’482 patent relate to a surgical system for repairing
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`a joint, such as the knee.
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`34. Knee replacement surgery is also known as knee arthroplasty.
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`Generally, there are two types of knee replacement surgeries: total knee and partial
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`knee replacement. During either type of knee replacement, an orthopaedic surgeon
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`replaces either a portion of or all of a damaged knee with an artificial device (also
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`known as a “prosthesis” or an “implant”). Although total knee arthroplasty
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`(“TKA”) is the most common procedure, some people can benefit from replacing
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`only a portion of the knee. This partial replacement is sometimes called a
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`unicondylar knee arthroplasty (“UKA”). These surgeries were known for decades
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`before ConforMIS filed the ’482 patent.
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`35. Knee replacement was not new when the patent was filed. Indeed,
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`surgeons had been performing knee replacement surgeries for decades prior to the
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`priority date of the ’482 patent.
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`A. Knee Anatomy
`
`36. The knee is a major weight-bearing joint that is held together by
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`muscles, ligaments, and soft tissue. Cartilage inside the joint provides a low-
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`friction surface that facilitates shock absorption and lubrication, which allows a
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`person to walk, run, lift, climb stairs, etc. and so on. The illustration below shows
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`the components of the knee relevant to the ’482 patent, namely the bones and the
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`articular cartilage:
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`
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`
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`In a healthy knee, the lower end of the femur and the upper end of the tibia are
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`covered by articular cartilage. The layer of bone directly beneath the articular
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`cartilage is called “subchondral bone.” In arthritic joints, some of the articular
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`cartilage is often worn or torn away, resulting in a surface that is partially articular
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`cartilage and partially exposed subchondral bone. Virtually all of my knee
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`replacement patients have at least some exposed subchondral bone due to the
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`cartilage being worn or torn away.
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`37. Cortical bone, also known as compact bone, is a hard, rigid form of
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`bone that forms the cortex, or outer shell, of most bones. With respect to the tibia
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`and femur, any bone surface that is not subchondral bone is cortical bone.
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`38. The term “osteophyte” generally refers to a bone spur, bony
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`outgrowth, or other bone deformity. Osteophytes commonly occur on the surface
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`of the bones of a joint, such as the femur and/or tibia. Osteophytes are very
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`common in patients with osteoarthritis who are considering knee replacement
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`surgery. At least 90% of my knee replacement patients have osteophytes present
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`on the femur or tibia. Osteophytes are visible in conventional images (e.g., MRI,
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`CT, x-ray) of the joint. For example, the below MRI from 1991 shows an
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`osteophyte (labeled “O” in Figure 4 and “B” in Figure 5) on a patient’s femur:
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`Prior to 2002, I used MRI hundreds of times to evaluate my patients’ knee joints,
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`including determining the size and location of any osteophytes.
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`B. Knee Replacement Surgery
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`39. When a knee has been damaged by a disease like osteoarthritis, knee
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`replacement surgery can replace the damaged portions with artificial components.
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`Before the surgeon can begin the procedure, however, the parts of the knee to be
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`replaced must be exposed. A surgeon will expose the operative areas by first
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`making an incision through the patient’s skin. The surgeon will then typically
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`access the operative area by moving the patella out of way to expose the end of the
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`femur.
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`40. To prepare the bone to receive an implant, the surgeon typically
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`removes a portion of bone and shapes the bone to receive the implant. For
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`example, the images below show the cuts that a surgeon might make to prepare the
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`end of a femur:
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`
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`Ex. 1011 at Figs. 16 (annotated) & 17. These cuts provide flat bone surfaces onto
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`which an implant component can be seated, as well as holes into which pegs on the
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`implant can be placed. The inner surface of the implant typically has a
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`corresponding geometry and two pegs that fit into the holes to secure the implant
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`in the proper location. In many cases, this is still how the femur is prepared for an
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`implant in TKA.
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`41. To help ensure that cuts and drill holes are made accurately, surgeons
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`typically use cutting guides with a guide surface that guides the saw used to cut (or
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`“resect”) the bone. Cutting guides, also known as resection guides or guide
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`members, come in many different shapes and sizes and have been long known in
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`the art. A prior art cutting guide with cutting apertures similar to those shown in
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`the ’482 patent is shown below (coloring and annotations added):
`
`
`
`’482 Patent (Ex. 1001)
`
`Robie (Ex. 1012)
`
`
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`42. As shown above, in some cutting guides, the guide is an aperture, slit
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`or slot for guiding a saw. In other cutting guides, the guide is simply a surface
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`against which the saw can be placed. Some cutting guides have both types of
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`guides. Whether a slot or a surface is used is a matter of surgeon preference.
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`Some surgeons prefer cutting guides with slots, which provide greater guidance of
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`the saw blade, while others prefer open cutting surfaces because they make it
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`easier for the surgeon to adjust the cut. Both were commonly used and would have
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`been known to a person of ordinary skill in the art, and a person of ordinary skill in
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`the art would further have known that slots and open cutting surfaces were
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`generally interchangeable.
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`43. By 2002, and certainly be 2006, it was common practice when
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`performing knee arthroplasty surgery to check the patient for osteophytes so that
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`they can be accounted for in the surgical planning. It is important for the surgeon
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`to have information about the presence of osteophytes both because they can be a
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`hindrance to the surgery (i.e. if there is difficulty positioning a cutting guide due to
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`an osteophyte) or a benefit (i.e. if a cutting guide can be aligned using an
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`osteophyte).
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`C.
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`
`
`Summary of Patient-Specific Guides
`i.
`
`Using MRI and/or CT to Image Joint Surfaces
`
`44. Using various imaging techniques, including MRI and CT scans, to
`
`obtain data of a diseased or damaged joint and determine the size, shape, or
`
`curvature of a patient’s joint surface was well known to those of ordinary skill in
`
`the art in the 1990s. The ’482 patent recognizes this:
`
`As will be appreciated by those of skill in the art, 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
`include the use of x-rays, magnetic resonance imaging (MRI),
`computed tomography scanning (CT, also known as computerized
`axial tomography or CAT), optical coherence tomography, ultrasound
`imaging techniques, and optical imaging techniques. (See, also,
`International Patent Publication WO 02/22014 to Alexander, et al.,
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`
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`published Mar. 21, 2002; U.S. Pat. No. 6,373,250 to Tsoref et al.,
`issued Apr. 16, 2002; and Vandeberg et al. (2002) Radiology 222:430-
`436). Contrast or other enhancing agents can be employed using any
`route of administration, e.g. intravenous, intra-articular, etc.
`
`
`Ex. 1001 at 32:3-15. The ’482 patent also 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:”
`
`As will be appreciated by those of skill in the art, the 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. See also, The
`Essential Physics of Medical Imaging (2nd Ed.), Jerrold T. Bushberg,
`et al.
`
`
`Id. at 30:34-52. I agree that imaging techniques for determining the shape of the
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`joint surfaces of a diseased or damaged joint were well known in the art prior to
`
`the filing date of the ’482 patent. By 2006 (and by 2002), imaging a patient’s
`
`cartilage surface, articular surface, and/or subchondral bone was commonplace.
`
`Prior to 2002, I routinely obtained this type of information from CT and MRI
`
`images of my patient’s knee and hip joints. Alexander (Ex. 1004), discussed in
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`more detail below, is just one example of how these imaging techniques were
`
`being used to evaluate the cartilage and bone in joints. Even Alexander recognizes
`
`that “a number of internal imaging techniques” were “known in the art” for
`
`generating a cartilage image. Ex. 1004 at 14.
`
`45. Several other prior art references similarly confirm that MRI could be
`
`used to obtain information about cartilage, including determining the size, shape,
`
`curvature, and/or thickness 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
`
`and/or cortical bone surface. Ex. 1004 at 14 (MRI can be used to “evaluate the
`
`subchondral bone for signal abnormalities”), 21 (MRI “demonstrate good contrast
`
`between low signal intensity cortical bone and high signal intensity bone marrow
`
`thereby facilitating 3D rendering of the femoral and tibial bone contours”), 26
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`-22-
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`
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`(software allows user to assess “the bones of the joint” and 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).
`
`47. The prior art also confirms that MRI, CT and x-ray could be used to
`
`obtain information about osteophytes. Ex. 1067 at S53 (MRI “can provide
`
`interesting information with regard to the evolution of osteophytes. . . .”); Ex. 1066
`
`at 703 (“Magnetic resonance imaging (MRI) is an excellent means to study
`
`noninvasively the anatomy of the knee joint to diagnose internal derangements.”),
`
`705-706 (“An example of osteophytes seen by MRI is shown in Fig. 1.”), Fig. 1
`
`(an “MR image” of a “patient with osteophytes”); Ex. 1068 at 183-86
`
`(“Osteophytes are also well delineated with MRI”); Ex. 1069 at 123-24 (further
`
`examples of osteophytes seen by MRI).
`
`ii.
`
`Using Imaging to Align a Surgical Tool Guide
`
`48.
`
`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
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`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 33 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.
`
` 
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` 
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` 
`
`Ex. 1036 at Figs. 4, 7-9 (illustrating that the femoral cutting guide 65 is aligned
`
`using the alignment guide 40).
`
`49. 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.
`
`
`
`iii.
`
`Using Imaging to Create Patient-Specific Surgical Tools
`
`50.
`
`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 a surface that is a
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`
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`“copy” or “negative” of a the “natural (i.e. not pre-treated) surface” of a patient’s
`
`joint. Ex. 1003 at 12.
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`51.
`
`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,” and then using the design to make
`
`a “real model” (shown below) 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.
`
`
`
`52. 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.
`
`53. Another patent application for a patient-specific cutting guide was
`
`filed by Schuster in 2000. Schuster described using CT or “nuclear spin resonance
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`tomogr