`
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`_________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_________________
`
`
`ZIMMER HOLDINGS, INC.
`ZIMMER, INC.
`Petitioners
`
`
`v.
`
`
`BONUTTI SKELETAL INNOVATIONS LLC
`Patent Owner
`
`
`Patent No. 7,837,736
`Filing Date: October 30, 2007
`Issue Date: November 23, 2010
`Title: MINIMALLY INVASIVE SURGICAL SYSTEMS AND METHODS
`
`__________________
`
`Inter Partes Review No. IPR2014-00191
`__________________
`
`CORRECTED
`PETITION FOR INTER PARTES REVIEW
`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 ET SEQ.
`
`
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`Inter Partes Review No. IPR2014-00191
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`TABLE OF CONTENTS
`
`Page
`
`I.
`
`NOTICES AND FORMALITIES ................................................................... 1
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`Real Parties In Interest .......................................................................... 1
`
`Related Matters ...................................................................................... 1
`
`Lead and Back-Up Counsel and Request for Pro Hac Vice
`Motion ................................................................................................... 1
`
`Service Information ............................................................................... 3
`
`Grounds for Standing ............................................................................ 3
`
`Power of Attorney ................................................................................. 3
`
`Fees ........................................................................................................ 3
`
`II.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 3
`
`III. OVERVIEW OF KNEE ANATOMY AND KNEE REPLACEMENT ......... 5
`
`A. Knee Anatomy ....................................................................................... 5
`
`B. Knee Replacement Surgery ................................................................... 7
`
`IV. OVERVIEW OF THE BONUTTI PATENT .................................................. 9
`
`A.
`
`The Claimed Invention .......................................................................... 9
`
`1.
`
`2.
`
`Claims 15-28 .............................................................................11
`
`Claims 31-36 .............................................................................12
`
`B.
`
`C.
`
`The Prosecution History ......................................................................13
`
`Priority Date of the Bonutti Patent ......................................................14
`
`V. OVERVIEW OF THE PRIOR ART RELIED UPON FOR THE
`CHALLENGE ...............................................................................................15
`
`A.
`
`The Walker Patent ...............................................................................15
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`B.
`
`C.
`
`The Insall ’283 Patent..........................................................................18
`
`The Insall ’658 Patent..........................................................................20
`
`VI. CLAIM CONSTRUCTION AND LEGAL STANDARDS .........................23
`
`A.
`
`Construction of Certain Claim Terms ................................................ 23
`
`
`
`
`
`
`
`
`
`1. “Protrusion” and “Recess” in Claims 15-21 and 25-28 .................24
`
`2. “Pin” and “Hole” in Claim 22 ........................................................25
`
`3. “Post” and “Cavity” in claims 31-36 .............................................26
`
`4. “Dovetail Joint,” Dovetail Pin” and “Dovetail Tail” in
`Claims 23 and 24 .................................................................................27
`
`B.
`
`Threshold Requirement for Inter Partes Review ................................28
`
`VII. STATEMENT OF REASONS FOR RELIEF REQUESTED ......................28
`
`A. Ground 1: Claims 15-22, 25-28 and 31-36 are Unpatentable as
`Being Anticipated by the Walker Patent .............................................28
`
`B. Ground 2: Claims 15-22, 25-28 and 31-36 are Unpatentable as
`Being Obvious Over the Walker Patent in Combination with
`Either or Both of: (1) the Insall ’283 Patent and (2) the Insall
`’658 Patent ...........................................................................................36
`
`C. Ground 3: Claims 23 and 24 are Unpatentable as Being
`Obvious Over the Walker Patent in Combination with the Insall
`’658 Patent, and Additionally or Alternatively Further in View
`of the Insall ’283 Patent ......................................................................42
`
`D. Ground 4: Claims 15-16, 18-28, 31 and 34-36 are Unpatentable
`as Being Anticipated by the Insall ’658 Patent ...................................44
`
`E.
`
`Ground 5: Claims 15-16, 18-22, 25-28, 31 and 34-36 are
`Unpatentable as Being Anticipated by the Insall ’283 Patent. ............52
`
`VIII. CONCLUSION ..............................................................................................60
`
`
`
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`TABLE OF AUTHORITIES
`
`
`
`Statutes
`
`35 U.S.C. § 102…………………………………………………………passim
`
`35 U.S.C. § 103…………………………………………………………passim
`
`35 U.S.C. §§ 311-319………...……………………………………………….1
`
`Rules
`
`37 C.F.R. § 42.100 et seq…...…………………………………………………1
`
`37 C.F.R. § 42.100(b) …...…………………………………………..………23
`
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`
`Exhibit 1001:
`
`Exhibit 1002:
`
`Exhibit 1003:
`
`Exhibit 1004:
`
`Exhibit 1005:
`
`Exhibit 1006:
`
`
`Exhibit 1007:
`
`
`Exhibit 1008:
`
`
`Exhibit 1009:
`
`
`Exhibit 1010:
`
`
`
`LIST OF EXHIBITS
`
`Bonutti U.S. Patent 7,837,736 (“Bonutti patent”)
`
`Walker et al. U.S. Patent 5,755,801 (“Walker patent”)
`
`Insall et al. U.S. Patent 6,319,283 (“Insall ’283 patent”)
`
`Insall et al. U.S. Patent 6,068,658 (“Insall ’658 patent”)
`
`Declaration of Arthur G. Erdman, Ph.D. (“Erdman Decl.”)
`
`Bonutti patent file history section - Response To Office Action,
`filed June 18, 2010
`
`Zimmer “Mbk Mobile Bearing Knee” brochure (“Mbk
`brochure”)
`
`Zimmer “Mbk Mobile Bearing Knee Implant & Instrument
`Order Form” (“Mbk order form”)
`
`Zimmer “Micro-Mill Instrument Surgical Technique for Mobile
`Bearing Knees” surgical guide (“Mbk Micro-Mill surgical
`guide”)
`
`Zimmer “Mbk Intramedullary Instrument Surgical Technique
`for Mobile Bearing Knee” surgical guide (“Mbk intramedullary
`surgical guide”)
`
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`
`
`Pursuant to 35 U.S.C. §§ 311-319 and 37 C.F.R. § 42.100 et seq., Zimmer
`
`Holdings, Inc. and Zimmer, Inc. (“Petitioners”) request inter partes review of
`
`claims 15-28 and 31-36 of the Bonutti U.S. Patent 7,837,736 (“Bonutti patent”)
`
`(Ex. 1001).
`
`I.
`
`
`
`NOTICES AND FORMALITIES
`A. Real Parties in Interest
`Zimmer Holdings, Inc. and Zimmer, Inc. are the real parties-in-interest for
`
`this petition (“Petition”).
`
`B. Related Matters
`The Bonutti patent is the subject of a patent infringement lawsuit brought by
`
`
`
`Bonutti Skeletal Innovations LLC (“Patent Owner”) against Petitioners in the
`
`United States District Court for the District of Delaware. The Case No. of the
`
`lawsuit is 1:12-cv-01107-GMS.
`
`
`
`C.
`
`Lead and Back-Up Counsel and Request for Pro Hac Vice Motion
`
`Lead Counsel
`
`Walter C. Linder
`
`Back-Up Counsel
`
`Daniel Lechleiter
`
`Faegre Baker Daniels LLP
`
`Faegre Baker Daniels LLP
`
`2200 Wells Fargo Center
`
`300 N. Meridian St.
`
`90 S. Seventh St.
`
`Suite 2700
`
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`Inter Partes Review No. IPR2014-00191
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`Minneapolis, MN 55402
`
`Indianapolis, IN 46204-1750
`
`Telephone: 612-766-8801
`
`Telephone: 317-237-1070
`
`Fax: 612-766-1600
`
`Fax: 317-237-1000
`
`Walter.Linder@FaegreBD.com
`
`Daniel.Lechleiter@FaegreBD.com
`
`Reg. No. 31,707
`
`Reg. No. 58,254
`
`
`
`Back-Up Counsel
`
`Kenneth Liebman
`
`Faegre Baker Daniels LLP
`
`2200 Wells Fargo Center
`
`90 S. Seventh St.
`
`Minneapolis, MN 55402
`
`Telephone: 612-766-8800
`
`Fax: 612-766-1600
`
`Ken.Liebman@FaegreBD.com
`
`
`
`
`Petitioners hereby request authorization to file a motion for Kenneth
`
`Liebman to appear pro hac vice. Mr. Liebman is an experienced litigation
`
`attorney, is the lead attorney for Petitioners in the litigation referred to in Section
`
`I.B. above, and has an established familiarity with the subject matter at issue in this
`
`proceeding. Petitioners will file such a motion upon the grant of this request.
`
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`D.
`
`Service Information
`
`
`
`Please address all correspondence to the lead counsel at the address shown
`
`above. Petitioners consent to electronic service to the email addresses above.
`
`E. Grounds for Standing
`
`
`
`Petitioners hereby certify that the patent for which review is sought is
`
`available for inter partes review and that Petitioners are not barred or estopped
`
`from requesting an inter partes review challenging the Bonutti patent claims on the
`
`grounds identified in this Petition.
`
`
`
`
`
`
`
`F.
`
`Power of Attorney
`
`A power of attorney designating counsel is being filed with this Petition.
`
`Fees
`
`G.
`The Commissioner is authorized to charge the $9,000 request fee, $14,000
`
`post-institution fee, $2,000 post-institution excess claims fee (total of $25,000),
`
`and any additional fees to our Deposit Account No. 06-0029, and to notify us of
`
`the same.
`
`II.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED
`
`
`
`Petitioners respectfully request that claims 15-28 and 31-36 of the Bonutti
`
`patent be canceled based on the following grounds. A full statement of the reasons
`
`for this request is presented in later sections of this Petition. These grounds are
`
`supported by a Declaration of Arthur G. Erdman, Ph.D. (“Erdman Decl.,” Ex.
`
`1005).
`
`3
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`
`
`Ground 1: Claims 15-22, 25-28 and 31-36 are unpatentable under 35 U.S.C.
`
`§ 102(b) as being anticipated by the Walker et al. U.S. Patent 5,755,801 (“Walker
`
`patent,” Ex.1002).1, 2
`
`
`
`Ground 2: Claims 15-22, 25-28 and 31-36 are unpatentable under 35 U.S.C.
`
`§ 103 as being obvious over the Walker patent in combination with either or both
`
`of: (1) the Insall et al. U.S. Patent 6,319,283 (“Insall ’283 Patent,” Ex. 1003), and
`
`(2) the Insall U.S. Patent 6,068,658 (“Insall ’658 patent,” Ex. 1004).
`
`
`
`Ground 3: Claims 23 and 24 are unpatentable under 35 U.S.C. § 103 as
`
`being obvious over the Walker patent in combination with the Insall ’658 patent,
`
`and additionally or alternatively further in view of the Insall ’283 patent (i.e., for
`
`the reasons of either or both Ground 1 and Ground 2 in combination with features
`
`relating to claims 23 and 24 disclosed in the Insall ’658 patent).
`
`1 The Bonutti patent issued prior to the America Invents Act (“AIA”). Petitioners
`
`therefore use the pre-AIA statutory framework in this petition.
`
` Petitioners are not challenging claim 37 in part because it fails to comply with the
`
` 2
`
`requirements of 35 U.S.C. § 112, ¶ 2. In particular, it is not clear what is meant by
`
`“said tibial tray slides with respect to said tibial tray.” Petitioners reserve the right
`
`to challenge the patentability of claim 37 if the Patent Owner attempts to correct
`
`claim 37 or asserts that claim 37 is in compliance with 35 U.S.C. § 112.
`
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`
`
`Ground 4: Claims 15-16, 18-28, 31 and 34-36 are unpatentable under 35
`
`U.S.C. §102(b) as being anticipated by the Insall ’658 patent.
`
`
`
`Ground 5: Claims 15-16, 18-22, 25-28, 31 and 34-36 are unpatentable
`
`under 35 U.S.C. § 102(a) and § 102(e) as being anticipated by the Insall ’283
`
`patent.
`
`III. OVERVIEW OF KNEE ANATOMY AND KNEE REPLACEMENT
`
`The challenged claims of the Bonutti patent relate generally to joint repair
`
`and replacement - surgical procedures known as joint arthroplasty. More
`
`particularly, the challenged claims relate to knee joint replacement implants. See,
`
`e.g., Ex. 1001, claims 15 and 31.
`
`
`
`
`
`A. Knee Anatomy
`
`A simplified description of the components and operation of the knee that
`
`are relevant to the challenged claims of the Bonutti patent can be provided with
`
`reference to the following illustrations of a right-side human knee joint and
`
`schematic.
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`
`
`
`
`
`
`
`As shown, the knee joint connects the femur (upper leg bone) to the tibia
`
`(lower leg bone). The anterior side (front) of the joint is protected by the patella
`
`(kneecap). Two generally convex-shaped rounded areas, known as condyles, are
`
`located at the distal end (bottom) of the femur. The lateral condyle is located on
`
`the lateral side (outside) of the femur, and the medial condyle is located on the
`
`medial side (inside) of the femur. A groove-shaped area on the distal end of the
`
`femur, known as the trochlear groove, separates the lateral and medial condyles.
`
`Ex. 1005, Erdman Decl., ¶¶ 14-15.
`
`
`
`The lateral and medial sides of the tibia have generally concave-shaped
`
`depressions that receive the corresponding condyles of the femur. A pad of
`
`cartilage, known as the meniscus, is located on the proximal end (top) of the tibia
`
`to protect the surfaces of the femur and tibia. Ex. 1005, Erdman Decl., ¶ 16.
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`When the knee bends, the condyles on the end of the femur move in a hinge-
`
`like manner with respect to the depressions in the tibia. The patella slides along
`
`the trochlear groove during bending of the knee. The kinematics of the knee joint
`
`are complex. In addition to providing the hinge-like movement, the condyles and
`
`meniscus accommodate axial rotation of the femur and tibia about their central
`
`longitudinal axes as the knee bends. Ex. 1005, Erdman Decl., ¶¶ 14, 18.
`
`
`
`
`
`B. Knee Replacement Surgery
`
`Features of a typical replacement knee implant or prosthesis that are
`
`pertinent to the challenged claims of the Bonutti patent can be described with
`
`reference to the following illustrations.
`
`Femur
`
`Femoral
`Component
`
`Articular
`Surface
`
`Tibial
`Tray
`
`Tibial
`Component
`
`Tibia
`
`Post
`
`Replacement Knee Prosthesis
`
`
`As shown, the replacement knee prosthesis includes a tibial component and
`
`Implanted Knee
`Prosthesis
`
`a femoral component. The tibial component includes a tibial tray, and a bearing or
`
`articular surface on the proximal upper surface of the tray. A mounting structure,
`
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`such as a stem or post, can extend distally from the underside or bottom of the
`
`tibial tray. The femoral component has lateral and medial condyles that replace the
`
`surfaces of the corresponding condyles of the patient’s femur. Similarly, the
`
`articular surface replaces the meniscus of the patient’s knee joint, and has lateral
`
`and medial depressions that receive the corresponding condyles of the femoral
`
`component. Ex. 1005, Erdman Decl., ¶¶ 21-26.
`
`
`
`During a surgical procedure to implant a prosthesis of this type, the surgeon
`
`will remove any remaining meniscus and cut off a thin slice from the proximal end
`
`of the tibia bone, a process known as resecting the tibia. The surgeon will also
`
`resect the femur by cutting the surfaces of the condyles to a shape that corresponds
`
`to the backside shape of the femoral component. The tibial component is mounted
`
`to the resected tibia, for example, by urging the stem into the bone. The femoral
`
`component is similarly mounted to the resected condyles of the femur. The
`
`articular surface is mounted to the upper surface of the tibial tray, between the tray
`
`and the femoral component. Ex. 1005, Erdman Decl., ¶¶ 28-38.
`
`
`
`In operation, the articular surface of the implant functions as a replacement
`
`for the meniscus. The condyles of the femoral component move in the depressions
`
`of the articular surface when the knee bends. Ex. 1005, Erdman Decl., ¶¶ 24-25.
`
`Additional information on knee replacement prostheses and associated surgical
`
`instruments and techniques that were known at the time of the Bonutti patent
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`invention is presented in the Zimmer Mbk brochure, Mbk order form, Mbk Micro-
`
`Mill surgical guide and Mbk intramedullary surgical guide. Exhibits 1007 -1010,
`
`respectively (the “Zimmer publications”). All of the Zimmer publications have
`
`copyright notices with publication dates of 1997 and/or 1998.
`
`IV. OVERVIEW OF THE BONUTTI PATENT
`
`
`
`A.
`
`The Claimed Invention
`
`The specification of the Bonutti patent describes a number of different
`
`implants, instruments and surgical procedures relating generally to knee and other
`
`joint replacement. See, e.g., Ex. 1001, col. 1, ln. 40-col. 2, ln. 61. All the claims
`
`of the Bonutti patent, however, are directed to joint replacement devices and
`
`methods having a sliding or otherwise movable component that corresponds to the
`
`meniscal component of the joint. In particular, all the claims generally recite: (1) a
`
`first or base component, such as a tibial tray, that is fixed to a bone on a first side
`
`of the joint (e.g., is fixed to the tibia), and (2) a second or movable component,
`
`such as a tibial tray insert, that moves with respect to the base component and has a
`
`surface that engages a bone on a second side of the joint (e.g., engages the
`
`condyles of the femur).
`
`In the context of knee joint replacement prostheses for the tibial side of the
`
`joint (i.e., tibial components), devices of this type are often referred to as “mobile
`
`bearing” knee prostheses. The Bonutti patent admits that mobile bearing knee
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`prostheses were known in the prior art. See, e.g., Ex. 1001, col. 101, ll. 35-43.
`
`The prior art Zimmer publications disclose and relate to such a mobile bearing
`
`implant referred to as the “Mbk” device. Exs. 1007-1010.
`
`The challenged claims of the Bonutti patent are directed to mobile bearing
`
`prostheses having specific features. In particular, the challenged claims are
`
`directed to mobile bearing prostheses that are configured to cause asymmetric
`
`movement of the movable component or tibial tray insert with respect to the center
`
`of the base component or tibial tray. An embodiment relating to the challenged
`
`claims is described in the Bonutti patent at columns 101-102 with respect to Fig.
`
`90. An annotated version of Fig. 90 is reproduced below.
`
`(annotated)
`
`Axis of Medial-Lateral
`Centerline
`Medial
`Side
`
`Lateral
`Side
`
`Central Axis of
`Spike
`
`
`The implant 1290 is a mobile bearing knee implant that includes a tibial
`
`component 1292 and a femoral component (not shown in Fig. 90). Tibial
`
`component 1292 includes a tray 1294 and a bearing insert 1296 (also referred to as
`
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`the “movable component” in the claims). Tray 1294 includes a plate member 1300
`
`and a tapered spike 1298 (i.e., a stem or post) that extends from the bottom or
`
`underside of the of the plate member for fixing the tibial component to the
`
`patient’s tibia. The upper surface 1302 of the plate member 1300 is provided with
`
`a post 1306 that cooperates with a recess 1308 located in the underside 1304 of the
`
`bearing insert 1296. The post 1306 and recess 1308 permit rotation of the bearing
`
`insert 1296 with respect to the tibial tray 1294. See, e.g., Ex. 1001, col. 101, ll. 6-
`
`34.
`
`As shown in Fig. 90, the post 1306 is not located directly over the spike
`
`1298 (a location defined as the center of the tibia). Ex. 1001, col. 101, ll. 55-56.
`
`Instead, the post 1306 is offset medially toward the medial compartment of the
`
`knee. Offsetting the post 1306 toward the medial compartment of the knee is said
`
`to recreate the natural pivoting motion of the knee. See, e.g., Ex. 1001, col. 101, ll.
`
`67.
`
`
`
`
`
`
`
`1.
`
`Claims 15-28
`
`Independent claim 15 and its dependent claims 16-28 recite a device to
`
`replace an articulating surface of a first side of a joint in a body. Limitations
`
`recited by claim 15 include, inter alia:
`
`
`
`(1)
`
`“a base component, including a bone contacting side … and a base
`
`sliding side on an opposite side … relative to said bone contacting side;”
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`
`
`(2)
`
`“a movable component, including a movable sliding side … matably
`
`positionable in sliding engagement with said base sliding side, and an articulating
`
`side on an opposite side … relative to said movable sliding side …;”
`
`
`
`(3)
`
`“a protrusion extending from … said base sliding side …, said
`
`protrusion substantially offset with respect to a midline of the first side of a joint;”
`
`and
`
`
`
`(4)
`
`“a recess sized to receive said protrusion, disposed in the … movable
`
`sliding side, said protrusion and recess matable to constrain movement of said first
`
`and second components relative to each other, thereby promoting movement of the
`
`joint within desired anatomical limits.” (emphasis added).
`
`
`
`In summary, claims 15-28 recite a mobile bearing prosthesis having a
`
`meniscal or movable component that moves with respect to the tray or base
`
`component about an axis that is substantially offset with respect to a midline on a
`
`first side of the joint.
`
`
`
`
`
`
`
`2.
`
`Claims 31-36
`
`Independent claim 31 and its dependent claims 32-36 recite a knee
`
`arthroplasty device. Limitations recited by claim 31 include, inter alia:
`
`
`
`(1)
`
`“a tibial tray including … an upper proximal surface, said proximal
`
`surface having … a post …, said post … offset from at least one of a medial-lateral
`
`centerline and an anterior-posterior centerline of said tibial tray;”
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`
`
`(2)
`
`“a tibial tray insert engageable with said proximal surface and having
`
`a mating second cavity …, said … mating cavity offset from at least one of the
`
`medial-lateral centerline and the anterior-posterior centerline of said tibial tray,
`
`wherein said mating cavity is adapted to receive at least a portion of said post …;”
`
`
`
`(3)
`
` “wherein said tibial tray insert rotationally moves with respect to said
`
`tibial tray, about said post, when the device is used within the body such that the
`
`rotation of the tibial tray insert is asymmetric with respect to at least one of the
`
`medial-lateral centerline and the anterior-posterior centerline of said tibial tray.”
`
`(emphasis added).
`
`
`
`In summary, claims 31-36 recite a mobile bearing tibial knee component
`
`having a meniscal component or insert that rotates asymmetrically with respect to
`
`the tibial tray about a post that is offset from either the medial-lateral centerline or
`
`the anterior-posterior centerline of said tibial tray.
`
`
`
`
`
`B. The Prosecution History
`
`Challenged claim 15 was originally added to the Bonutti patent application
`
`(as claim 138) in a restriction requirement response filed on January 19, 2010. In
`
`the next Office Action mailed on March 11, 2010, claim 15 and all the claims
`
`depending therefrom were rejected under 35 U.S.C. § 102 as being anticipated by
`
`the Herrington U.S. Patent 5,997,577. In a responsive amendment filed on June
`
`18, 2010, the applicant made amendments that it asserted “serve to clarify the
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`present invention and are independent of patentability,” and argued that the
`
`Herrington patent disclosed a tibial component having a tibial insert “firmly fixed”
`
`to the tibial tray when the tibial component is used in the body. Ex. 1006, June 18,
`
`2010 response, pp. 11-12. In effect, the patent applicant distinguished the applied
`
`Herrington patent as not even disclosing a mobile bearing knee component, much
`
`less such a component having the features recited in the claims. All the claims
`
`were allowed in a Notice of Allowability that followed the June 18, 2010 response.
`
`
`
` Challenged claim 31 was originally added to the Bonutti patent application
`
`(as claim 162), along with its dependent claims, in the June 18, 2010 response. Ex.
`
`1006. These claims were also allowed in the Notice of Allowability that followed
`
`that response (i.e., they were never rejected on the basis of prior art). The issue fee
`
`was subsequently paid and the patent issued in due course.
`
`
`
`
`
`C.
`
`Priority Date of the Bonutti Patent
`
`The Bonutti patent claims priority to a number of other U.S. patent
`
`applications. Based on a review of these earlier applications, application no.
`
`10/191,751, filed on July 8, 2002 (now patent 7,104,996), is the earliest that
`
`includes the mobile bearing tibial component embodiment discussed above and
`
`described with reference to Fig. 90 in the Bonutti patent. The priority date for the
`
`claims of the Bonutti patent challenged in this Petition is July 8, 2002.
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`
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`The Petitioners reserve the right to respond accordingly in the event the
`
`Patent Owner alleges an earlier date of invention.
`
`V. OVERVIEW OF THE PRIOR ART RELIED UPON FOR THE
`CHALLENGE
`
`
`
`
`
`A.
`
`The Walker Patent
`
`The Walker et al. U.S. Patent 5,755,801 (“Walker patent,” Ex. 1002)
`
`discloses a replacement knee prosthesis. The Walker patent issued on May 26,
`
`1998, and is a § 102(b) prior art patent to the Bonutti patent.
`
`The prosthesis has a femoral component and a tibial component. The tibial
`
`component is a “mobile bearing” device that includes a tibia-engaging tibial
`
`platform and a meniscal component configured to provide for limited movement of
`
`the meniscal component on the tibial platform. Importantly, like the challenged
`
`claims of the Bonutti patent, the Walker patent discloses a mobile meniscal
`
`component that moves about an axis that is substantially offset in the medial
`
`direction from the center of the component.
`
`The “second embodiment” of the Walker patent shown in Figs. 2-2c has
`
`certain features of particular relevance to the challenged claims of the Bonutti
`
`patent. As noted in the Walker patent, the second embodiment shown in Figs. 2-2c
`
`“has a number of similarities with that shown in FIGS. 1 to 1e and only the
`
`differences are described.” Ex. 1002, col. 4, ll. 3-6. FIGS. 4a-4d also show
`
`features of the embodiments shown in FIGS. 1-3. See, e.g., Ex. 1002, col. 5, ll. 23-
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`28. For these reasons, the relevant features of the device shown in the Walker
`
`patent are described below with reference to the drawing figures of the different
`
`embodiments.
`
`Meniscal
`Component 142
`
`Femoral
`Component 141
`
`Tibial
`Platform 150
`
`Tibial
`Component
`
`(Annotated)
`
`As shown in the annotated version of Fig. 4c above, the replacement knee
`
`prosthesis has a femoral component 141 and a two-part tibial component that
`
`includes a tibial platform 150 and the movable meniscal component 142. See, e.g.,
`
`Ex. 1002, col. 4, ln. 59-col. 5, ln. 37.
`
`Tibial
`Platform 1
`
`Upper Surface 4
`Stud 5
`
`Upper Bearing Surface
`
`Post P
`
`Underside
`
`(Annotated)
`
`
`
`As shown in the annotated version of Fig. 1b, above, the tibial platform 1 has an
`
`Underside
`
`(Annotated)
`Meniscal
`Component
`
`underside that engages the tibia, and an upper surface 4 to which the meniscal
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`component 44 is mounted. The movable meniscal component 44 is shown in the
`
`annotated version of Fig. 1e, above, and has an underside and an upper bearing
`
`surface side. The upper side has depressions 23 to receive the condylar bearing
`
`surfaces of the femoral component 141 (shown in Fig. 4c, above). See, e.g., Ex.
`
`1002, col. 3, ln. 12-col. 4, ln. 53.
`
`Tibial Platform 41
`
`Upper Surface
`Of Tibial Platform
`
`Meniscal Component
`Movement Path
`
`Meniscal
`Component 44
`
`Posterior
`
`Stud 42
`
`Slot 43
`
`Recess
`
`Abutment
`
`Lateral
`Side
`
`Medial
`Side
`
`Anterior
`
`(Annotated)
`
`Medial-Lateral
`Centerline
`
`
`
`
`
`The above annotated version of Fig. 2 illustrates other features and the
`
`operation of the tibial component. An abutment 50 is upstanding on the upper
`
`surface of the tibial platform 41. As shown, the abutment 50 is located on the
`
`medial side of the medial-lateral centerline of the tibial platform 41. A recess 51 is
`
`formed in the medial side of the meniscal component 44. The meniscal component
`
`44 is fitted to the tibial platform 41 by engaging the abutment 50 in the recess 51.
`
`The meniscal component 44 can thereby rotate along an arcuate path about the
`
`medially displaced axis of the abutment 50. A stop that limits the range of rotation
`
`of the meniscal component 44 in the posterior direction with respect to the tibial
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`platform 41, and that prevents the meniscal component from lifting off the tibial
`
`platform, is provided by the stud 42 that extends from the tibial platform and is
`
`received in the slot 43 in the underside of the meniscal component. See, e.g., Ex.
`
`1002, col. 4, ll. 3-53.
`
`
`
`B.
`
`The Insall ’283 Patent
`
`The Insall et al. U.S. Patent 6,319,283 (“Insall ’283 patent,” Ex. 1003)
`
`discloses an orthopaedic knee implant. The Insall ’283 patent was filed on July 2,
`
`1999, issued on November 20, 2001, and is prior art to the Bonutti patent under §§
`
`102(a) and (e).
`
`The implant has a femoral component and a tibial component. The tibial
`
`component is a “mobile bearing” device that includes a tibia-engaging tibial tray
`
`and a bearing configured to provide for limited movement of the bearing on the
`
`tibial tray. Importantly, like the challenged claims of the Bonutti patent, the Insall
`
`’283 patent discloses a mobile bearing that moves about an axis that is
`
`substantially offset from the centers of the tray and bearing.
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`FIG. 5
`(annotated)
`
`Femoral
`Component 14
`
`Tibial
`Component
`10
`
`Bearing 20
`
`Tray 18
`Tibial Plateau
`Stem 24
`
`
`As shown in the annotated version of Fig. 5 above, the implant has a femoral
`
`
`
`component 14, and a two-part tibial component 10 that includes a tibial tray 18 and
`
`the movable bearing 20. See, e.g., Ex. 1003, col. 3, ll. 1-13.
`
`Articular Bearing
`Surface
`
`Bearing
`
`Backing Surface
`Upper Surface
`Tray
`Anterior-Posterior
`Centerline
`Medial
`Underside
`Projection 28
`Tibial
`Plateau 22
`
`Notch 44
`Posterior
`Lateral
`Side
`
`Anterior
`Side
`
`Post 32
`Stem 24
`
`Articular Bearing Surface 34
`
`FIG. 2
`(annotated)
`
`Tibial
`Plateau 22
`
`Backing Surface 46
`
`Central Axis
`of Stem
`
`FIG. 1
`(annotated)
`
`Stem 24 Central Axis
`Of Stem
`
`Projection 28
`Notch 44
`Post 32
`
`Opening 38
`
`Anterior-
`Posterior
`Centerline
`
`
`
`The annotated versions of Figs. 1 and 2, above, illustrate features of the tray
`
`18 and bearing 20 in greater detail. Tibial plateau 22 has an underside that engages
`
`the tibia, and a proximal or upper surface to which the bearing 20 is mounted. The
`
`movable bearing 20 has an underside or backing surface 46 and an upper, articular
`
`bearing surface 34. The articular bearing surface 34 has a pair of concave portions
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`on opposite sides of a projection 36 that engage the corresponding condyles of the
`
`femoral component 14. See, e.g., Ex. 1003, col. 3, ln. 14-col. 4, ln. 14.
`
`
`
`A projection 28 extends from the upper surface of the tibial plateau 22. As
`
`shown in Figs. 1 and 2, the projection 28 is located on the anterior side of the
`
`anterior-posterior centerline of the tibial plateau 22. The projection 28 is disposed
`
`in an opening 38 in the backing surface 46 of the bearing 20. The opening 38 and
`
`projection 28 allow rotational movement of the bearing 20 relative to the tibial
`
`plateau 22. A post 32 that extends from the tibial plateau 22 is rec