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`Paper
`Filed on behalf of: BONUTTI SKELETAL INNOVATIONS LLC
` Date: May 30, 2014
`
`By: Cary Kappel, Lead Counsel
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`William Gehris, Backup Counsel
`
`Davidson, Davidson & Kappel, LLC
`
`485 Seventh Avenue
`
` New York, NY 10018
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`Telephone (212) 736-1257
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`
`
`(212) 736-2015
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`Facsimile (212) 736-2427
`
`E-mail:
`ckappel@ddkpatent.com
`
`
`
`wgehris@ddkpatent.com
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`SMITH & NEPHEW,
`INC.
`
`Petitioner,
`
`
`
`
`v.
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`
`
`
`
`BONUTTI SKELETAL INNOVATIONS LLC
`
`Patent Owner
`Case: IPR2013-00629
`Patent 7,806,896
`_______________
`DECLARATION OF DR. SCOTT D. SCHOIFET, M.D. IN
`SUPPORT OF PATENT OWNER RESPONSE
`Exhibit 2004
`Smith & Nephew v.
`Bonutti Skeletal Innovations LLC
`Trial IPR 2013‐00629
`
`
`
`Declaration of Dr. Scott D. Schoifet
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`Case: IPR2013-00629
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`Introduction
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`I, Scott D. Schoifet, hereby declare under the penalty of perjury:
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`1.
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`2.
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`I reside at 19 Macclesfield Drive, Medford, NJ. 08055.
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`I am a board certified surgeon specializing in Total Joint
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`Replacement and Adult Reconstructive Surgery in the practice of Reconstructive
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`Orthopedics P.A.
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`3.
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`I have been retained as an expert witness and asked to render opinions
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`regarding certain matters pertaining to the inter partes review (IPR2013-00629) of
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`the Bonutti U.S. Patent No. 7,806,896 (“the '896 patent”). I offer this declaration
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`(“Declaration”) in support of Bonutti Skeletal’s Patent Owner Response.
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`4.
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`I obtained my Medical Degree from Columbia University College of
`
`Physicians and Surgeons, New York, New York in 1983. I completed my General
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`Surgery Residency at St. Vincent’s Hospital, New York, New York, in 1985; and
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`my Orthopedic Residency at the Strong Memorial Hospital, University of
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`Rochester, Rochester, New York in 1988. I completed my Fellowship in Total
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`Joint Replacement and Adult Reconstructive Surgery at the Mayo Clinic in
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`Rochester, Minnesota, in 1989, where I was appointed as an Instructor in
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`Orthopedic Surgery. I obtained my board certification from the American Board of
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`Orthopedic Surgery in 1991.
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`5.
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`Shortly after completing my Fellowship, I entered private practice in
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`September, 1989. I joined Reconstructive Orthopedics P.A. in May, 1990. I am an
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`instructor for Minimally Invasive Surgery Quad Sparing for Partial and Total Knee
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`Replacements, both nationally and internationally.
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`6.
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`I have performed over 7,000 total knee and total hip replacements. I
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`performed my first minimally invasive surgery (“MIS”) knee replacement in
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`November of 2003 and have performed over 4,800 MIS total knee replacements
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`since then. I currently average 700 MIS total knee replacements per year.
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`7.
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`I am a fellow of the American College of Surgeons (FACS), and the
`
`American Academy of Orthopaedic Surgeons (FAAOS). I also am a member of
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`the American Association of Hip and Knee Surgeons (AAHKS).
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`8.
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`A more detailed account of my work experience and qualifications is
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`included in my curriculum vitae, which is attached as Appendix A to this
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`Declaration.
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`9.
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`In connection with my study of this matter and reaching the opinions
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`stated herein, I have reviewed and considered:
`
`(A)
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`the '896 patent and its prosecution history before the United States
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`Patent and Trademark Office, focusing on claim 1;
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`(B) Scott L. Delp, et al., “Computer Assisted Knee Replacement,” 354
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`Clinical Orthopaedics and Related Research (1998) (“Delp”) (Exhibit 1003);
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`Declaration of Dr. Scott D. Schoifet
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`Case: IPR2013-00629
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`(C) S. David Stulberg, et al., “Computer-Assisted Total Knee Replacement
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`Arthroplasty,” 10(1) Operative Techniques in Orthopaedics (Jan. 2000) (“Stulberg”)
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`(Exhibit 1005);
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`(D) Roderick H. Turner, et al., “Geometric and Anametric Total Knee
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`Replacement,” in Total Knee Replacement (A.A. Savastano, M.D. ed. 1980)
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`(“Turner”) (Exhibit 1008);
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`(E) Stryker Howmedica Osteonics, Scorpio Single Axis Total Knee
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`System – Passport Total A.R. Total Knee Instruments – Passport A.R. Surgical
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`Technique (May 2000) (“Scorpio”) (Exhibit 1009);
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`(F) U.S. Patent 5,871,018 (February 16, 1999) (“Delp ‘018”) (Exhibit
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`1004);
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`(G)
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`the Institution Decision in IPR 2013-00629, paper 10 (February 28,
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`2014)(“Institution Decision”), focusing on the discussion of the instituted grounds
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`of Stulberg in view of Turner or Scorpio, and Delp in view of Turner or Scorpio;
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`and
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`(H)
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`the Declaration Of Jay D. Mabrey, MD, MBA (Exhibit 1002), focusing
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`on the discussion of Stulberg in view of Turner or Scorpio, and Delp in view of
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`Turner or Scorpio.
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`10.
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`I also have a Scorpio Anterior Resection Cutting Guide, of the type
`
`described in Scorpio, which I examined in preparing this Declaration. What I refer
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`to as the Anterior Resection Guide includes three parts: the A/R Anterior Skim
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`Cutting Guide bearing Model No. 7650-5003-A, the alignment guide bearing
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`reference number I-K1287AR02, and an intramedullary rod bearding Model No.
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`7650-1026. Photographs of the Anterior Resection Guide that I examined are
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`included in Exhibit 2005, which I have also reviewed.
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`11.
`
`I understand that the Patent Office has instituted a review of claim 1
`
`of the '896 patent based on the following two grounds: (i) Whether claim 1 would
`
`have been obvious to a person of ordinary skill in the art based on the disclosure of
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`Stulberg in view of either Turner or Scorpio; and (ii) Whether claim 1 would have
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`been obvious to a person of ordinary skill in the art based on the disclosure of Delp
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`in view of either Turner or Scorpio.
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`Priority Date
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`12.
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`In preparing this Declaration, I have reviewed the '896 patent and
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`considered each document cited herein, in light of the knowledge of a person of
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`ordinary skill in the art in the field of knee arthroplasty, as it stood in the timeframe
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`of 2000-2003.
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`13.
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`I have been instructed by counsel that the effective filing date of the
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`'896 patent with respect to the subject matter of claim 1 is August 28, 2001. I have
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`also been informed that the Petitioner may assert other effective filing dates, up to
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`and including November 25, 2003. In any event, my opinion would remain
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`unchanged regardless of the effective filing date chosen within the timeframe of
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`2000-2003.
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`
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`The Person Of Ordinary Skill In The Art
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`14.
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`Based on my experience, it is my opinion that a person of ordinary
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`skill in the art to which the '896 patent relates in the 2000-2003 timeframe would
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`have an undergraduate degree in mechanical engineering or biomechanical
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`engineering or graduate coursework covering topics relevant to biomechanical
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`devices or orthopedics, or an orthopedic surgeon having experience performing
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`knee arthroplasty or joint replacement procedures. In this Declaration, whenever I
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`refer to a person of ordinary skill in the art, it is to be understood that I refer to a
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`person of that skill in the 2000-2003 timeframe.
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`General Background Of The '896 Patent
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`15.
`
` The '896 patent in general describes methods and surgical
`
`techniques for knee-joint replacement using MIS techniques. Knee replacement
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`surgery is commonly referred to as knee arthroplasty.
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`16. A portion of a human leg, including a knee joint, is schematically
`
`illustrated in Figure 6 of the '896 patent, reproduced below. Generally speaking,
`
`the knee is the portion of the leg where the femur 126, tibia 214, and patella 120
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`meet. In every-day use, the femur is the thigh bone, the tibia is the shin bone, and
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`the patella is the knee cap.
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`Description of the State of the Art at the Timeframe of 2000-2003
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`17.
`
` Prior to the methods disclosed in the '896 patent, knee replacement
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`surgery was invasive and involved a relatively long incision. To obtain access to
`
`the knee joint, the surgeon needed to cut and strip soft tissue from the bone to
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`provide the surgeon with full access to and visualization of the knee joint to permit
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`the surgeon to position surgical instruments relative to the ends of the femur and
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`tibia. To further increase access to and visualization of the femur and tibia, the
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`patella was moved from its normal position and everted. A patella is everted when
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`it is turned over or flipped over so that the inner side of the patella is exposed and
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`facing outward and away from the femur and tibia. Everting the patella was
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`necessary to move the patella sufficiently out of the way so that the instruments,
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`including cutting blocks used to guide cutting instruments for shaping the bones to
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`7
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`receive implants, could be properly positioned on the femur and tibia.
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`18.
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`The cutting blocks for the timeframe 2000-2003 were large, bulky
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`and invasive, and a person of ordinary skill in the art would not have thought
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`otherwise because making a large incision, splitting the quadriceps, and everting
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`the patella was common practice. Large incisions, such as 12 to 16 inches, were
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`simply accepted whether the procedure involved computer-assisted navigation or
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`not. It was well understood that shortening the width of a guide surface would
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`reduce precision because it would not allow the entire cut of the femur to be guided
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`as precisely. In the timeframe 2000-2003 it was believed that more precise cuts
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`would result in better outcomes.
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`Claim Construction
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`19.
`
` I understand that the inter partes review was instituted with regard
`
`to claim 1 which is set forth below:
`
`Claim 1 of the '896 patent
`
`1. A method of replacing at least a portion of a patient's knee, the
`method comprising the steps of:
` making an incision in a knee portion of a leg of the patient;
`determining a position of a cutting guide using references
`derived independently from an intramedullary device;
`positioning a cutting guide using the determined position,
`passing the cutting guide through the incision and on a surface of a
`distal end portion of an unresected femur, the cutting guide secured to
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`the bone free of an extramedullary or intramedullary alignment rod;
`moving a cutting tool through the incision into engagement
`with a guide surface on the cutting guide; and
`forming at least an initial cut on the femur by moving the
`cutting tool along the guide surface;
`attaching a replacement portion of the knee to the cut surface,
`the replacement portion having a transverse dimension that is larger
`than a transverse dimension of the guide surface.
`
`20.
`
`I have been instructed that I should interpret the terms of the claim
`
`following a legal standard defined as the “broadest reasonable interpretation
`
`consistent with the specification.” I have been informed that under the broadest
`
`reasonable interpretation standard, claim terms are given their ordinary and
`
`customary meaning, as would be understood by one of ordinary skill in the art in
`
`the context of the entire disclosure.
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`21.
`
`I have also been instructed to interpret certain claim terms in the
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`following manner for purposes of this inter partes review:
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`
`
`
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`(1) “cutting guide” – a “guide that has a guide surface”; and
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`(2) “guide surface” – “a surface that guides a cutting instrument.”
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`Overview Of The '896 Patent
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`22.
`
` The '896 patent describes a number of surgical devices and surgical
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`methods, and discusses the use of reduced size cutting guides in knee replacement
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`surgery. ('896 patent, col. 3, ll. 15-30, col. 17, 47-60, col. 69-71, col. 103-104).
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`23.
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`The '896 patent explains that the “benefits of having a smaller
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`incision include improved cosmetic results, improved rehab, less dissection of
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`muscle and soft tissue, and preservation of the quadriceps mechanism.” (Id., col.
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`15, ll. 15-18). It explains that this is achieved by using reduced size cutting guides,
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`“the size of the incision … can be reduced”, and “reducing the size of the incision
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`… reduces damage to body tissue of the patient.” (Id., col. 18, ll. 36-38).
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`24.
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`The '896 patent discloses down sizing of instrumentation to be
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`smaller than the implants positioned in the knee portion of the patient.
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`Specifically, the opposite ends of the instrumentation may be spaced apart by a
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`distance which is less than the distance between lateral and medial epicondyles on
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`a femur or tibia in the leg of the patient. The length of the cutting guide surface is
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`less, in the transverse dimension, than the transverse dimension of replacement
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`part. The cutting surface may be less than the length of the cut to be made on the
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`bone, and the cut on the bone is completed using the previously cut surface as a
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`guide for the cutting tool. (Col. 3, ll. 15-29, Figures 11-13, 53, 54, 94, 95, 96, for
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`example).
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`25.
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`The '896 patent contrasts its reduced size cutting guides from
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`conventional cutting guides such as the Scorpio cutting guides of Exhibit 1009.
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`The '896 patent explains that the "Scorpio" (TM) Single Axis Total Knee System is
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`a known anterior resection guide and femoral alignment guide with a distance
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`between opposite ends of the guide being greater than the traverse dimensions of
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`the femoral and tibial implants. (Col. 18, ll. 18-31)
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`26.
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`The '896 patent describes various reduced size cutting guides such as
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`femoral and tibial cutting guides secured with intramedullary alignment rods (col.
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`17, ll. 15-17, Figures 9-13), and femoral and tibial cutting guides secured with
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`extramedullary alignment rods (Figures 37-38, col. 44, ll. 20-36, col. 17, ll. 15-17).
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`27. Also described in the specification are femoral cutting guides that are
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`secured to the bone free of an extramedullary or intramedullary alignment rod
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`(Figures 53, 54, cols. 69-71, Figures 94, 95, cols. 103-104).
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`28.
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`The '896 patent also discusses the “guide surface” of the
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`aforementioned cutting guides. (Col. 20, ll. 15-21 (Figures 9-13), col. 45, ll. 46-48
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`(Figure 38), col. 69, ll. 6-34 (Figure 53), col. 70, ll. 27-63 (Figure 54), col. 105, ll.
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`13-27 (Figure 94)).
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`29.
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`The '896 patent explains that the guide surface extends only part way
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`across the femur (or tibia in the case of Figures 37-38). (Col. 20, ll. 18-19 (Figure
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`13), col. 45, ll. 45-62 (Figure 38), col. 69, ll. 47-49 (Figure 53), col. 71, ll. 9-12,
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`22-25, 45-49 (Figure 54), col. 105, ll. 17-19 (Figure 94)).
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`30.
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`The '896 patent explains that an initial cut can be made with the
`
`guide surface, and then the remainder of the cut can be made using the initial cut as
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`a guide. (Col. 20, ll. 52-col. 21, ll. 9 (Figure 13), col. 45, ll. 60-67 (Figure 38), col.
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`11
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`69, ll. 51-63 (Figure 53), col. 71, ll. 12-16, 25-29, 45-49 (Figure 54), col. 105, ll.
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`19-22 (Fig. 94), col. 110, ll. 45-50).
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`31.
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` The '896 patent explains that the use of shorter cutting surfaces
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`allows for reduced incision sizes (Id., col. 17, ll. 47-50) and, accordingly
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`“improved cosmetic results, improved rehab, less dissection of muscle and soft
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`tissue, and preservation of the quadriceps mechanism.” (Id., col. 15, ll. 15-18, see
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`also col. 18, ll. 34-38, col. 19, ll. 36-42, col. 21, ll. 28-30).
`
`32. With reference to the cutting guide of Figures 10-13 which is secured
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`with an intramedullary alignment rod, the '896 patent describes guide surface 178:
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`('896 patent, col. 20, ll. 15-46).
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`33.
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`I note that guide surface 178 is shown as extending substantially
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`across the entire cutting guide 138 notwithstanding the fact that the slot extends
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`across only about two-thirds of the front face of the cutting guide 138. In
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`particular, the guide surface 178 narrows as it extends from top to bottom of Figure
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`13 (or right to left from the perspective of Figure 11), but remains continuous on
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`the bone-side1 of the guide.
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`34. With regard to the cutting guide of Figure 37-38 which is secured
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`with an extramedullary alignment rod, the '896 patent describes guide surface 530
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`at column 45, line 45 to column 46, line. 20. This surface also extends to the bone
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`side of the guide.
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`35. With regard to the cutting guide of Figure 53, the '896 patent
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`describes guide surfaces 762, 764, 770, 780. (col. 69, ll. 1-50). As shown in Figure
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`53, femoral alignment guide 750 is positioned on the on the distal end of the femur
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`126 and is secured to the femur 126 by pins 784, 786. (Id. col. 69, ll. 35-41). No
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`intramedullary or extramedullary alignment rod is used. The cutting guide extends
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`only part way across the distal end of the femur. (Id., col. 69, ll. 47-48). As with
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`the guide surface 178 of Figure 13, the guide surfaces of Figure 53 extend to the
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`bone side of the cutting guide.
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`36. With regard to the cutting guide of Figure 54, the '896 patent
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`describes guide surfaces 806, 812, 816, 820, 824. (Col. 70, ll. 19-62). As shown in
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`Figure 54, the alignment guide 800 is a “side cutting guide” which is positioned on
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`1 From the perspective of Figure 13, the bone side is the left side of the guide 138.
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`a lateral surface 802 of the femur 126 and secured to the femur 126 by pins 830,
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`832. (Id., col. 70, ll. 19-20, col. 71, ll. 4-5). No intramedullary or extramedullary
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`alignment rod is used. As with the guide surfaces of Figures 13 and 53, the guide
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`surfaces of Figure 54 extend to the bone side of the cutting guide.
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`37.
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`Cutting guide 1372 shown in Figures 94 and 95 includes a base 1376
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`and cutting guide surface 1374. Cutting guide 1372 can be secured to the bone free
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`of an extramedullary or intramedullary alignment rod. (Id., col. 104, ll. 49-51 (“If
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`desired, the base 1376 could be pinned directly to the femur in a manner analogous
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`to the cutting guide 800 (FIG. 54)”)). Further, “the guide surface 1374 can be made
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`so that the size of the guided portion of the cuts can be adjusted depending upon
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`the size of the bone and the implant that is to be used;” and “the guide surface 1374
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`can be made to have a length less than the extent of the cut to be formed on the
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`distal end portion of the femur.” (Id., col. 105, ll. 13-19). The cutting guide 1372
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`can be “positioned on the femur using a computer navigation system.” (Id., col.
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`104, ll. 53-54).
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`Stulberg
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`38.
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`Stulberg is directed to computer-assisted total knee replacement and
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`is concerned with improving the accuracy of the instrumentation used in total knee
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`replacement procedures. It focuses on using computer-assisted technology to
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`improve the consistency of the location of reference points that guide the
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`placement of the bone cutting guides. Stulberg reports that “alignment errors of
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`greater than 3° are associated with more rapid failure and less satisfactory results . .
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`. .” (Stulberg, p. 25) Stulberg also reports that while “[m]echanical alignment
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`guides have improved . . . accuracy” (id.), they are still unsatisfactory in that they
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`have “fundamental limitations that limit their ultimate accuracy.” (Id.).
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`39.
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`Stulberg states that the computer-assisted techniques it describes use
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`“conventional incision and exposure.” (Id. p. 27). Stulberg does not indicate that a
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`smaller incision size is necessary, and does not in any way indicate that the size of
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`the alignment guides or cutting guides is of interest. Nothing in Stulberg suggests
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`that the size of conventional mechanical alignment guides or cutting guides is
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`problematic. My review of Stulberg shows that it does not object to
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`extramedullary or intramedullary alignment guides per se, but rather is concerned
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`with more accurate placement of the cutting and alignment guides. This is
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`indicated, for example, in its computer-assisted tibial procedure, an extramedullary
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`alignment guide is used (Figure 12), and the computer technique is used to more
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`finely tune the position of the cutting guide. (Id. p. 29, right column, final two
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`paras.).
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`40.
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` To elaborate, as shown in Figures 16B and 17, the guide surface of
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`the cutting guide is larger than the replacement component. It can be seen that the
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`guide surface extends beyond the femur. The replacement component (Figure 20)
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`clearly has a transverse dimension that is smaller than the transverse dimension of
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`the guide surface. There is no indication whatsoever that this is disadvantageous
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`and in fact no indication anywhere that the relative sizes of the guide surface and
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`the replacement portion are of interest. Rather, Stulberg is concerned with
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`accurate placement of the cutting guides so that a more precise cut can be made.
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`(Id. at p. 25 (Abst.), p. 25, left. col., first par., p. 25, right col., second par.)
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`Delp
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`41. Delp is concerned with the accurate and consistent alignment of knee
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`implants for total knee replacement using various computer-assisted techniques.
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`Its focus is on the accuracy of mechanical alignment systems: “[a]lthough
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`mechanical alignment guides have been designed to improve alignment accuracy,
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`there are several fundamental limitations of this technology that will inhibit
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`additional improvements.” (Delp, p. 49, left col.).
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`42.
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`Like Stulberg, Delp does not express any concern for the size of
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`conventional incisions, or the size of conventional alignment devices or cutting
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`guides. Rather, it is the accuracy of the alignment and cutting guides that is of
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`concern. (Id., p. 49, left col., p. 50, left col.).
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`43. Delp discusses three distinct technologies: (i) computer integrated
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`instruments, (id., pp. 50-51); (ii) image guided knee replacement, (id., pp. 51-53);
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`and (iii) robot assisted knee replacement, (id., pp. 53-54).
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`44.
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`The first is computer integrated instruments - According to Delp,
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`this technique uses an optical localizer to determine the mechanical axes of the
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`femur and tibia, and then uses a computer workstation to display the position of the
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`cutting block relative to its desired position. Once the cutting block is “oriented
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`properly it is secured in position and the cuts are made with a standard oscillating
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`saw.” (Id., p. 51, left col.). As reported at page 55, this technique uses “standard
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`cutting guides.” (emphasis added). Accordingly, although Delp does not
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`specifically discuss how the cutting guide is secured, it follows that since a
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`“standard cutting guide” is used, it is to be secured in the standard way.
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`45.
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`The second is image guided knee replacement – In this technique,
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`according to Delp, three dimensional computer models of the patient’s femur and
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`tibia are constructed using computer tomographic data. (Id., p. 51, last par.). An
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`intraoperative system is used to “determine the position and orientation of the
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`patient’s femur and tibia and to guide the surgeon in the placement of the cutting
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`jigs.” (Id., p. 52, last two pars.) According to Delp, the intraoperative system
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`includes a graphics workstation, a coordinate measurement probe, and “a set of
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`cutting blocks that have been modified to attach to the measurement probe.” There
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`is no suggestion that the cutting blocks/cutting jigs are in any other way different
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`than standard cutting blocks/jigs. There is no indication that they are not secured
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`to the femur/tibia in a conventional manner.
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`46.
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`The third is robot assisted knee replacement – Three robot assisted
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`techniques are described: Kienzle et al - In this technique, a robotic procedure is
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`used to more accurately “drill the alignment holes for conventional cutting blocks
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`for femoral and tibial implants.” (Id., p. 54, 1st par.); Fadda et al- In this technique,
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`“a sophisticated pre-operative planning system [is linked] to a standard industrial
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`robot to allow placement of cutting blocks and machining of bone.” (Id., p. 54, 2nd
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`par.); and Davies et al.- In this technique, an active constraint robot (ACROBOT)
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`to cut the femur without the use of cutting guides. (Id., p. 54 (“virtual cutting
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`block”)).
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`47.
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`The computer integrated technique, the image guided technique and
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`the first two robot assisted techniques use standard cutting blocks, presumably
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`secured in their standard way, and the last uses no cutting block at all. However,
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`in each technique, Delp is concerned with the accuracy of the placement of the
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`cuts, not the size of the cutting surfaces (Id., p.49, Abs., p. 50, left col., first and
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`second pars.)
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`Turner
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`48.
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`The Turner article is published in 1980, 18 years prior to Delp, and
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`20 years prior to Stulberg. The subject matter of Turner is directed to geometric
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`and anametric total knee replacement (“TKR”) techniques. The cutting guide that
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`is relied upon by Dr. Mabrey (Figure 8) is employed in the geometric technique.
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`The geometric TKR was a primitive design that had been abandoned as a failure by
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`1990, long before Delp or Stulberg. In particular, it was found that while the
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`theory of the geometric TKR was that “(4) although stability in flexion [as the knee
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`flexes] may be sacrificed somewhat with spherical surfaces, the requirements for
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`stability in flexion are no nearly as significant functionally as are the requirements
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`for stability at or near full extension,” (Turner, p. 174), the opposite was in fact
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`true because flexion instability is one of the primary causes of total knee pain and
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`failure, not extension instability. By 1988, the geometric TKR was known to have
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`a 10 year survivability of only 69%.
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`49.
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`In the technique described in Turner, the femoral cutting guide is
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`mounted with an extramedullary alignment rod, as illustrated in Figure 8:
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`50. A person of ordinary skill in the art at the timeframe 2000-2003
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`would recognize the above figure as an extramedullary alignment rod which
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`terminates with a cutting guide. A person of ordinary skill in the art at the
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`timeframe 2000-2003 would also recognize that this cutting guide, whose
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`extramedullary alignment is achieved by inserting “[t]he femoral cutting guide …
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`in the midline, deep to the suprapatellar pouch,” and which is thereafter used to cut
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`the femur “with a power or hand saw parallel with the guide that is approximately
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`30 degrees to the long axis of the femur” would provide a far more imprecise cut
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`than the techniques criticized in Delp and Stulberg. In the timeframe of 2000-
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`2003, a person of ordinary skill in the art would not consider using the femoral
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`cutting guide of Figure 8 in a knee replacement surgery.
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`51.
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`There is no discussion of limiting incision sizes in Turner, and no
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`indication that the relative size of the cutting surface of the cutting guide and the
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`replacement component is of any interest.
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`Scorpio
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`52.
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`Scorpio is a publication describing the Scorpio Single Axis Total
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`Knee System and various instruments for use in total knee replacement surgery. In
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`particular, Scorpio discusses Osteonics Passport A/R Instrumentation designed for
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`anteriorly based femoral resections. I am familiar with the Scorpio Single Axis
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`Total Knee System, and used much of the instrumentation described in this
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`publication, including the anterior resection guide, at least as early as 2003.
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`53.
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` In Scorpio, the initial femoral cut is made using the anterior
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`resection guide shown below:
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`54.
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`The anterior resection guide is mounted to the femur with an
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`intramedullary alignment rod, as shown in Figure 9 and in Figure 12. (Id., pp. 6-7).
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`55.
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`In his Declaration, and at paragraph 70 in particular, Dr. Mabrey
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`alleges that the Anterior Resection Guide is composed of two guide surfaces, of
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`which he alleges surface D1 (below) is less than the transverse dimension of the
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`replacement portion (implant D2):
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`56.
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`I disagree for a number of reasons which I will discuss later in this
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`declaration. However, to begin with, Scorpio only illustrates the cutting guide
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`from the perspective of the physician:
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`57.
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`There is no illustration in Scorpio that shows the cutting guide from
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`the opposite (i.e. bone-side) perspective from Figure 15.
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`58. A person of ordinary skill in the art considering Scorpio at the
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`timeframe 2000-2003 would understand that in order to create the anterior cut on
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`the femur, the guide surface on the bone side of the anterior resection guide would
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`have to extend continuously between the lateral and medial sides of the cutting
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`guide (i.e. from the right side to the left side of the guide when viewed from the
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`perspective of Figure 15).
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`59.
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`In fact, the Scorpio Anterior Resection Guide that I used in 2003 had
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`a single continuous guide surface that extends across the entire cutting guide. The
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`guide surface narrowed and widened from one side of the cutting guide to the
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`other, but it extended as a single continuous surface throughout. This continuous
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`surface can be seen in the photos of the Anterior Resection Guide in Exhibit 2005,
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`and I have included two drawings illustrating the guide from the bone-side as
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`Exhibit 2007:
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`(Exh. 2007)
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`(Exh. 2005, Photos from the perspective of Scorpio Figures 14, 15, and 16)
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`(Exh. 2005, Photos from the bone side of the device of Scorpio)
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`60.
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`There is no discussion of limiting incision sizes in Scorpio, and no
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`indication that the relative size of the cutting surface of the cutting guide and the
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`replacement component is of any interest.
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`Stulberg in view of Turner
`Stulberg
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`61.
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`Stulberg is concerned with providing improved accuracy in
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`positioning cutting guides by using computer-assisted techniques to more
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`accurately position the cutting guide on the femur. A person of ordinary skill in
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`the art at the 2000-2003 timeframe would understand that Stulberg is principally
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`concerned with increasing the precision of the cuts made using the cutting guides.
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`This was typical at the timeframe 2000-2003 as it was believed that more precise
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`cuts would result in better outcomes. That turned out not to be true in practice.
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`Accuracy is repeatedly stressed in Stulberg. (Stulberg, Abst., and first three pars.
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`on p. 25; p. 27 (“The goal of the computer-assisted system is to increase the
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`accuracy and reproducibility…”); and p. 33).
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`62. A person of ordinary skill in the art would also understand that the
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`cutting tools and blocks in Stulberg are very large and invasive without sparing the
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`quadriceps and thus not concerned with minimally invasive procedures. A person
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`of ordinary skill in the art in 2000-2003 familiar with Stulburg would also
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`recognize that Stulberg is not at all concerned with performing a minimally
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`invasive procedure, and thus, not concerned with the size of cutti
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