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. 7,806,896
`Filing Date: November 25, 2003
`Issue Date: October 5, 2010
`Title: KNEE ARTHROPLASTY METHOD
`
`__________________
`
`Inter Partes Review No. 2013-00321
`__________________
`
`CORRECTED
`PETITION FOR INTER PARTES REVIEW
`UNDER 35 U.S.C. §§ 311-319 AND 37 C.F.R. § 42.100 ET SEQ.
`
`

`

`Inter Partes Review No. 2014-00321
`Corrected Petition For Inter Partes Review
`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 ...................................................................................................2
`
`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.
`
`B.
`
`Knee Anatomy.......................................................................................5
`
`Knee Replacement Surgery...................................................................7
`
`IV. OVERVIEW OF THE BONUTTI PATENT..................................................9
`
`A.
`
`B.
`
`C.
`
`The Specification ................................................................................10
`
`Claims 40-47 ......................................................................................12
`
`Priority Date of the Bonutti Patent......................................................13
`
`V.
`
`OVERVIEW OF THE PRIOR ART RELIED UPON FOR THE
`CHALLENGE ...............................................................................................13
`
`A.
`
`B.
`
`C.
`
`The Radermacher PCT Publication.....................................................13
`
`The Radermacher Article ....................................................................20
`
`The Androphy Patent .........................................................................21
`
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`Inter Partes Review No. 2014-00321
`Corrected Petition For Inter Partes Review
`D.
`The Insall Patent .................................................................................23
`
`E.
`
`F.
`
`Zimmer’s NexGen Epi Technique Guide ..........................................24
`
`Zimmer’s Casey Technique Guide .....................................................25
`
`VI. CLAIM CONSTRUCTION AND LEGAL STANDARDS .........................26
`
`A.
`
`B.
`
`Construction of Certain Claim Terms.................................................26
`
`Legal Standards...................................................................................27
`
`VII. STATEMENT OF REASONS FOR RELIEF REQUESTED......................27
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`Ground 1: Claims 40-41 and 44-45 are Unpatentable as Being
`Anticipated by the Radermacher PCT Publication, or
`Alternatively as Being Obvious Over the Radermacher PCT
`Publication in View of the Radermacher Article................................27
`
`Ground 2: Claim 42 is Unpatentable for the Reasons of Ground
`1, Either Alone or Further in View of the NexGen Epi
`Technique Guide .................................................................................32
`
`Ground 3: Claim 43 is Unpatentable for the Reasons of Ground
`1, and Further in View of Either the Androphy Patent or the
`Casey Technique Guide .....................................................................34
`
`Ground 4: Claims 46-47 are Unpatentable for the Reasons of
`Ground 1, Either Alone or Further in View of the Insall Patent.........36
`
`Ground 5: Claims 40 and 42 are Unpatentable as Being
`Obvious Over the Combination of the Radermacher PCT
`Publication, the Radermacher Article and the NexGen Epi
`Technique Guide .................................................................................39
`
`VIII. CONCLUSION .............................................................................................45
`
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`TABLE OF AUTHORITIES
`
`Statutes
`
`35 U.S.C. § 102…………………………………………………………passim
`
`35 U.S.C. § 103…………………………………………………………passim
`
`35 U.S.C. § 112………...…………………………………………………….26
`
`35 U.S.C. §§ 311-319………...……………………………………………….1
`
`35 U.S.C. § 314(a) ………...…………………………..…………………….1
`
`Rules
`
`37 C.F.R. § 42.100 et seq…...…………………………………………………1
`
`37 C.F.R. § 42.100(b) …...…………………………………………..………26
`
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`Inter Partes Review No. 2014-00321
`Corrected Petition For Inter Partes Review
`LIST OF EXHIBITS
`
`Exhibit 1001:
`
`Bonutti U.S. Patent 7,806,896 (“Bonutti Patent”)
`
`Exhibit 1002:
`
`Declaration of Arthur G. Erdman, Ph.D (“Erdman Decl.”)
`
`Exhibit 1003:
`
`Exhibit 1004:
`
`Radermacher PCT International Publication No. WO 93/25157
`(“Radermacher PCT Publication”)
`
`Radermacher et al., Computer-Integrated Orthopaedic Surgery:
`Connection of Planning and Execution in Surgical Intervention
`(“Radermacher Article”)
`
`Exhibit 1005:
`
`Androphy U.S. Patent 4,567,885 (“Androphy Patent”)
`
`Exhibit 1006:
`
`Insall et al. U.S. Patent 6,068,658 (“Insall Patent”)
`
`Exhibit 1007:
`
`Zimmer technique guide entitled “casey total knee,” dated 1976
`(the “Casey Technique Guide”)
`
`Exhibit 1008:
`
`Zimmer technique guide entitled “NexGen Complete Knee
`Solution – Epicondylar Instrumentation Surgical Technique for
`Legacy Posterior Stabilized Knee,” dated 1996 (the “NexGen
`Epi Technique Guide”)
`
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`Inter Partes Review No. 2014-00321
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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 40-47 of the Bonutti U.S. Patent 7,806,896 (“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. Petitioners are also the petitioners in Inter Partes
`
`Review Nos. IPR2014-00191, directed to U.S. patent 7,837,736, and IPR2014-
`
`00311, directed to U.S. patent 7,959,635, both of which are also the subject of the
`
`above-identified lawsuit. Petitioners are aware of Inter Partes Review No.
`
`IPR2013-00629, which is also directed to U.S. patent 7,806,896 that is the subject
`
`of this Petition and brought by another petitioner. Petitioner is also aware of Inter
`
`Partes Review Nos. IPR2013-00605, IPR2013-00620 and IPR2013-00621
`
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`Inter Partes Review No. 2014-00321
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`brought by other petitioners, and that are directed to other patents that are the
`
`subject of the above-identified lawsuit.
`
`C.
`
`Lead and Back-Up Counsel and Request for Pro Hac Vice Motion
`
`Lead Counsel
`Walter C. Linder
`Faegre Baker Daniels LLP
`2200 Wells Fargo Center
`90 S. Seventh St.
`Minneapolis, MN 55402
`Telephone: 612-766-8801
`Fax: 612-766-1600
`Walter.Linder@FaegreBD.com
`Reg. No. 31,707
`
`Back-Up Counsel
`Daniel Lechleiter
`Faegre Baker Daniels LLP
`300 N. Meridian St.
`Suite 2700
`Indianapolis, IN 46204-1750
`Telephone: 317-237-1070
`Fax: 317-237-1000
`Daniel.Lechleiter@FaegreBD.com
`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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`Inter Partes Review No. 2014-00321
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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.
`
`G.
`
`Fees
`
`The $9,000 request fee and the $14,000 post-institution fee (total of
`
`$23,000) are being paid with the electronic filing of this petition. The
`
`Commissioner is authorized to charge 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 40-47 of the Bonutti patent be
`
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`canceled based on the following grounds.1 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. 1002).
`
`•
`
`Ground 1: Claims 40-41 and 44-45 are unpatentable under 35 U.S.C.
`
`§ 102 as being anticipated by the Radermacher PCT Publication (Ex. 1003), and in
`
`addition or alternatively under 35 U.S.C. § 103 as being obvious over the
`
`Radermacher PCT Publication in combination with the Radermacher Article (Ex.
`
`1004).
`
`•
`
`Ground 2: Claim 42, which depends from claim 40, is unpatentable
`
`under 35 U.S.C. § 102 and 35 U.S.C. § 103 for the reasons of Ground 1 (i.e., as
`
`applied to claim 40), either alone or further in view of the NexGen Epi Technique
`
`Guide (Ex. 1008).
`
`•
`
`Ground 3: Claim 43, which depends from claim 40, is unpatentable
`
`under 35 U.S.C. § 102 and 35 U.S.C. § 103 for the reasons of Ground 1 (i.e., as
`
`applied to claim 40), and further in view of either or both of the Androphy Patent
`
`(Ex. 1005) and the Casey Technique Guide (Ex. 1007).
`
`
`
`1 The Bonutti patent issued prior to the America Invents Act (“AIA”). Petitioners
`
`therefore use the pre-AIA statutory framework in this petition.
`
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`•
`Ground 4: Claims 46 and 47, which depend from claims 45 and 40,
`
`respectively, are unpatentable under 35 U.S.C. § 102 and 35 U.S.C. § 103 for the
`
`reasons of Ground 1 (i.e., as applied to claims 45 and 40), either alone or further in
`
`view of the Insall Patent (Ex. 1006).
`
`•
`
`Ground 5: Claims 40 and 42 are unpatentable under 35 U.S.C. § 103
`
`as being obvious over the combination of the Radermacher PCT Publication, the
`
`Radermacher Article and the NexGen Epi Technique Guide.
`
`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 a method for implanting a prosthesis
`
`using a custom fabricated alignment guide positionable on a bone using references
`
`derived independently of an intramedullary device. See, e.g., Ex. 1001, claim 40.
`
`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 illustration of a human knee joint.
`
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`Inter Partes Review No. 2014-00321
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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. 1002, 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. 1002, 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. 1002, 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.
`
`As shown, the replacement knee prosthesis includes a tibial component and
`
`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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`Corrected Petition For Inter Partes Review
`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. 1002, Erdman Decl., ¶¶ 21-25.
`
`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. To ensure that the resected
`
`surfaces of the femur substantially match the backside shape of the femoral
`
`component, surgeons use specific tools, referred to as cutting guides, which guide
`
`the saw along the desired cutting path. For example, one prior art cutting guide
`
`discussed below utilized guide slots that captured the saw blade and forced it to
`
`remain within a designated cutting plane. Other prior art cutting guides used open
`
`surfaces to maintain the saw blade within the cutting plane. Ex. 1002, Erdman
`
`Decl., ¶¶ 29-36.
`
`The cutting guides must, of course, be accurately placed with respect to the
`
`femur, and surgeons use specific tools, referred to as alignment guides, for that
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`Corrected Petition For Inter Partes Review
`purpose. One prior art alignment guide is an intramedullary rod that is placed into
`
`the femur. To use that tool, the surgeon drilled a hole in the distal end of the femur
`
`to access the intramedullary canal. A rod (i.e., the intramedullary rod) was inserted
`
`into the intramedullary canal and cutting guides were then placed using the
`
`intramedullary rod as a reference point. Another rod-based alignment guide was
`
`the extramedullary rod, which was fixed to a lower portion of the leg and was used
`
`to place a cutting guide with that rod as a reference. Still other alignment guides
`
`were also known in the prior art, including alignment guides that did not use an
`
`intramedullary rod or an extramedullary rod, as noted below in more detail. Ex.
`
`1002, Erdman Decl., ¶¶ 29-36, 46-72.
`
`Once the femur and tibia are resected, 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. 1002, Erdman Decl., ¶¶ 37-38.
`
`IV. OVERVIEW OF THE BONUTTI PATENT
`
`The specification of the Bonutti patent describes a number of different
`
`implants, instruments and surgical procedures relating generally to knee and other
`
`joint replacements. See, e.g., Ex. 1001, col. 1, ln. 40-col. 2, ln. 61. The challenged
`
`claims of the patent, however, are directed to the use of instruments that help a
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`Corrected Petition For Inter Partes Review
`surgeon resect the bones of that patient in a precise manner. In particular, the
`
`challenged independent claim 40 recites, inter alia, (1) “obtaining an alignment
`
`guide positionable on a bone using references derived independently of an
`
`intramedullary device,” (2) “wherein the alignment guide is custom fabricated for
`
`the patient based on patient imaging information ,” and (3) “referencing a cutting
`
`guide with respect to the alignment guide.” The remaining challenged claims
`
`depend directly or indirectly from claim 40.
`
`
`
`A.
`
`The Specification
`
`The specification of the Bonutti patent includes no description of a “custom
`
`fabricated” “alignment guide” and a “cutting guide” that can be referenced to such
`
`an alignment guide. The “optically created guide” or “three dimensional image”
`
`850 shown in Fig. 55 and described in columns 72-75 of the Bonutti patent may be
`
`the most relevant described embodiment with respect to the alignment guide and
`
`cutting guide recited in claim 40. An annotated version of Fig. 55 is reproduced
`
`below.
`
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`Inter Partes Review No. 2014-00321
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`
`As shown in that figure, a projector (858) uses light beams (852, 854, 862)
`
`to create an “optical” guide for resecting the surfaces of the bone. The Bonutti
`
`patent states that the “optically created guide” is a holographic, three dimensional
`
`image (850) projected onto the distal end portion (124) of the femur (126). That
`
`image (850) “provides a guide for alignment of a [saw] blade 170,” which includes
`
`its own “laser light beams 866 and 868” to align the saw blade (170) with the
`
`optical image (850). See, e.g., Ex. 1001, col. 72, ln. 6 to col. 75, ln. 27. Thus, the
`
`holographic image serves as a guide for the saw so that the ensuing cuts are
`
`accurately located.
`
`As noted above, however, several prominent limitations in the challenged
`
`claims do not seem to find support in this section or in the Bonutti patent in
`
`general. For example, the Bonutti patent does not appear to disclose any physical
`
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`structure or alignment guide that is custom fabricated. The Bonutti patent also
`
`does not appear to disclose the use of image data to fabricate an alignment guide,
`
`or the use of pins in conjunction with a custom fabricated alignment guide to
`
`secure the cutting guide to a bone. Nor does the Bonutti patent disclose a custom
`
`fabricated alignment guide that is separate from a cutting guide.
`
`B.
`
`Claims 40-47
`
`Independent claim 40 and its dependent claims recite a method of replacing
`
`at least a portion of a joint in a patient. The limitations of claim 40 are reproduced
`
`below:
`
`“[1] obtaining an alignment guide positionable on a bone using references
`
`derived independently of an intramedullary device, wherein the alignment guide
`
`is custom fabricated for the patient based on patient imaging information;
`
`[2] positioning the alignment guide in relation to the surface of an unresected
`
`bone of the joint;
`
`[3] referencing a cutting guide with respect to the alignment guide; and
`
`[4] cutting the unresected bone of the joint for the first time, by moving a
`
`cutting tool along a guide surface of the cutting guide.” (emphasis added).
`
`In summary, claims 40-47 recite an alignment guide that is created using
`
`patient imaging information. That alignment guide is placed on the unresected
`
`bone using references derived independently of an intramedullary device and is
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`used to position a cutting guide having a guide surface. A cutting tool is moved
`
`along the guide surface to cut the bone for the first time.
`
`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.
`
`09/941,185, filed on August 28, 2001 (now patent 6,702,821), appears to be the
`
`earliest that includes the holographic image approach discussed above and
`
`described with reference to Fig. 55 in the Bonutti patent. The priority date for the
`
`claims of the Bonutti patent challenged in this Petition is no earlier than August 28,
`
`2001.
`
`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 Radermacher PCT Publication
`
`The Radermacher PCT Publication WO 93/25157 (Ex. 1003) relates to the
`
`treatment of osseous structures, such as cutting bones forming a joint as part of a
`
`joint replacement operation. The Radermacher PCT Publication published on
`
`December 23, 1993, and is prior art to the Bonutti patent under 35 U.S.C. § 102(b).
`
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`The Radermacher PCT Publication was cited during prosecution of the Bonutti
`
`patent, but was not relied upon by the examiner or distinguished by the patentee.
`
`The Radermacher PCT Publication acknowledges that, in joint arthroscopy
`
`operations, it is important to precisely resect the bone and describes several known
`
`techniques for accurately aligning a cutting tool for those resecting cuts. For
`
`example, the Radermacher PCT Publication notes the use of a “laser beam” to
`
`“display cutting paths” on the bone. Ex. 1003, pages 8, 33. In addition to those
`
`laser-based guiding techniques, the Radermacher PCT Publication also describes
`
`how, nearly a decade before the priority date of the Bonutti patent, surgeons used
`
`“standard tool guides,” such as “saw templates,” to precisely resect the bones
`
`during a joint-replacement operation. Ex. 1003, p. 11, 13. One exemplary
`
`“standard tool guide” identified in the Radermacher PCT Publication is the
`
`“cutting” template described in the Androphy Patent (Ex. 1005, discussed in more
`
`detail below). Ex. 1003, page 2.
`
`While those “standard” cutting guides are useful for guiding a cutting tool
`
`(e.g., a saw or drill) along a particular path, it is important that those cutting guides
`
`be correctly placed with respect to the bone. To address that issue, the
`
`Radermacher PCT Publication discloses particular techniques for positioning tool
`
`guides with respect to the bone using an “individual template.” That individual
`
`template incorporates a surface created as a customized, “three-dimensional
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`negative mold” of the “natural (i.e. not pre-treated) surface” of the patient’s bone.
`
`Ex. 1003, page 12. Because each patient’s bone has a complex surface structure,
`
`using a three-dimensional negative mold ensures that the individual template will
`
`fit onto the uncut bone surface “in exclusively one clearly defined position….”
`
`Ex. 1003, pages 10-11. To create the individual template and its negative mold,
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`“split images” are taken of the targeted bone, and those images are used to generate
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`“the three-dimensional shape of the osseous structure and the surface thereof.” Ex.
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`1003, page 10. The individual template is then formed to “cop[y] the surface of
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`the osseous structure” to ensure its unique fit. Ex. 1003, page 10.
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`Because the individual template aligns with the bone in only one position
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`and orientation, the cutting guides can be properly aligned with the bone via the
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`individual template. To that end, “guide means or reference or flange engagement
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`points for standardized tool guides” are “defined in or on the individual template.”
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`Ex. 1002, page 11. Through those engagement points, standard tool guides can be
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`placed at a particular position and orientation. Ex. 1003, page 11. The
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`Radermacher PCT Publication also teaches that cutting guides can be incorporated
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`into the individual template itself. Ex. 1003, page 12. Thus, an effective
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`positioning system for ensuring accurate cuts “is realized by simply setting the
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`individual template onto the exposed surface of the bone.” Ex. 1003, page 11.
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`The Radermacher PCT Publication discloses that individual templates can be
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`used in conjunction with a variety of surgical procedures and with “almost any
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`random device[],” Ex. 1003, page 30. In addition, it specifically discusses two
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`procedures of particular import to the instant challenge. In particular, the
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`Radermacher PCT Publication teaches that the individual template can be used “for
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`preparation of a prosthesis seat of a knee-joint head prosthesis” as well as “for hip-
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`joint individual endoprothesis.” Ex. 1003, pages 18, 19.
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`When discussing knee-joint replacement operations, the Radermacher PCT
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`Publication refers to Fig. 13a, reproduced below with annotations added.
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`As shown in that figure, the “individual template 4 is set onto the bone 17 in
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`a defined manner, abutting the contact faces 1.” With the individual template in
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`place, the surgeon can begin to resect the femur. For example, a cut in the form of
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`a bore can be made using the drill sleeve 11 as a guide. Another cut “is formed
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`along the cutting plane 20a.” Other cuts, such as the cut along surface 20c, can be
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`performed using “an additional template 27.” The remaining cuts are made to fully
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`prepare the bone to receive the prosthesis. Ex. 1003, page 30; Ex. 1002, Erdman
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`Decl., ¶¶ 64, 65.
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`Regarding the hip-joint operations, the Radermacher PCT Publication refers
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`to Figs. 10a-10d, and Fig. 10a is reproduced below with annotations added.
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`As shown in that figure and described in the publication, the “individual template
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`4” is created as a “three-dimensional negative mold” of the femur. See also Ex.
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`1003, Fig. 10c. As a result, the individual template is placed on the femur in
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`exactly the desired position and orientation. A saw 25 then creates the first
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`resecting cut into the femur. To ensure that the saw accurately resects the femur, a
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`“parallel guide 26” and a “rear contour analogous limitation 24” are coupled to the
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`individual template 4. Those components provide guiding surfaces on which the
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`saw slides as it makes its cut into the femur. Specifically, and as best shown in the
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`lower-right corner of Fig. 10b, reproduced below, the parallel guide 26 includes an
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`upper part and a lower part. The lower part has a longitudinal groove and the
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`upper part has a transverse groove.
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`The saw 25 is slidingly coupled to the upper part via the transverse groove, and the
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`upper part is slidingly coupled to the lower part via the longitudinal groove. As a
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`result, the saw 25 is able to move longitudinally and transversely within the cutting
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`plane 20. Ex. 1002, Erdman Decl., ¶ 56.
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`As for the “rear contour analogous limitation 24,” that component uses a
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`curved surface to restrain the saw 25 along a particular curved path. See, e.g., Fig.
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`10c, below, with annotations added:
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`Specifically, as shown in these figures, the saw 25 includes guide pins 23 that slide
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`along that curved surface as the saw 25 moves longitudinally and transversely
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`within the cutting plane 20. Thus, the parallel guide 26 operates as a cutting guide
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`by restraining the saw 25 to movement within the cutting plane 20 and the rear
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`contour analogous limitation 24 also operates as a cutting guide by restraining the
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`saw 25 to movement along a particular path with the cutting plane 20. Ex. 1003,
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`pages 25-26; Ex. 1002, Erdman Decl., ¶ 56.
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`In sum, the Radermacher PCT Publication discloses surgical procedures
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`involving individual templates that are custom three-dimensional negative molds
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`of the patient’s bone and are placed on the exposed bone before any cuts are made.
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`The individual templates are designed to secure standard cutting tools, e.g., cutting
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`guides, in particular positions so that those cutting guides are in proper alignment
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`with the bone. Ex. 1002, Erdman Decl., ¶¶ 60-69.
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`B.
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`The Radermacher Article
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`The Radermacher Article (Ex. 1004) relates to the treatment of osseous
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`structures, such as cutting bones forming a joint as part of a joint replacement
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`operation. This article was published in 1995 and is prior art to the Bonutti patent
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`under 35 U.S.C. § 102(b). The Radermacher Article was not cited during
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`prosecution of the Bonutti patent.
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`The Radermacher Article (Ex. 1004), like the Radermacher PCT
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`Publication, describes an “individual template” created from “image data” of a
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`patient. Ex. 1004, page 453. The image data contains “all necessary information
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`about contours and surfaces of [the] bony structures” that will be the subject of the
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`operation. Ex. 1004, pages 453-454. The individual template created from that
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`image data has “contact faces that copy without undercutting the complementary
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`shape of segments of bone surface.” Ex. 1004, page 453. As a result, the
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`individual “template can be intraoperatively placed form-closed on the bone
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`surface in exactly the predefined position and orientation.” Ex. 1004, page 453.
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`The individual template is then used to “position tools exactly in the pre-
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`operatively defined position and orientation” using “tool guides within or at the
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`body of the individual template.” Ex. 1004, pages 454-455. The individual
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`template could, alternatively, include “reference points (bores) for the fixation of
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`reuseable standard tool guides.” Ex. 1004, page 455. Thus, the Radermacher
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`Article discloses an individual template that is custom made for a particular patient
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`using image data from that patient. That individual template may include bores
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`that are used to “fix” or position standard tool guides for subsequent procedures,
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`such as cutting the bone. Ex. 1002, Erdman Decl., ¶¶ 70-72.
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`C.
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`The Androphy Patent
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`The Androphy U.S. Patent 4,567,885 (“the Androphy Patent,” Ex. 1005)
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`discloses a “knee resection system for preparing a knee joint for a prosthesis,” (Ex.
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`1005, Abstract), which can be used to perform a “total knee replacement,” Ex.
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`1005, claim 1. The Androphy Patent issued on February 4, 1986, and is prior art to
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`the Bonutti patent under §102(b). The Androphy Patent was not cited during
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`prosecution of the Bonutti patent.
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`As part of that “knee resection s