`
`
`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. Unassigned
`__________________
`
`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. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
`
`
`TABLE OF CONTENTS
`
`Page
`
`I.
`
`NOTICES AND FORMALITIES ................................................................... 2
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`F.
`
`G.
`
`Real Parties In Interest .......................................................................... 2
`
`Related Matters ...................................................................................... 2
`
`Lead and Back-Up Counsel ................................................................... 3
`
`Service Information ............................................................................... 3
`
`Grounds for Standing ............................................................................ 4
`
`Power of Attorney ................................................................................. 4
`
`Fees ........................................................................................................ 4
`
`II.
`
`STATEMENT OF THE PRECISE RELIEF REQUESTED .......................... 5
`
`III. OVERVIEW OF KNEE ANATOMY AND KNEE REPLACEMENT ......... 5
`
`A. Knee Anatomy ....................................................................................... 6
`
`B. Knee Replacement Surgery ................................................................... 7
`
`IV. OVERVIEW OF THE BONUTTI PATENT ................................................ 10
`
`A.
`
`B.
`
`C.
`
`D.
`
`The Specification ................................................................................ 11
`
`Claim 40 ............................................................................................. 14
`
`Claim 43 ............................................................................................. 15
`
`Priority Date of the Bonutti Patent ...................................................... 15
`
`V. OVERVIEW OF THE PRIOR ART RELIED UPON FOR THE
`CHALLENGE ............................................................................................... 15
`
`A.
`
`B.
`
`The Radermacher ‘157 Publication ..................................................... 15
`
`The Radermacher Article .................................................................... 20
`
`
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
`
`
`C. The Androphy Patent ......................................................................... 21
`
`VI. CLAIM CONSTRUCTION AND LEGAL STANDARDS ......................... 24
`
`A.
`
`B.
`
`Construction of Certain Claim Terms ................................................. 24
`
`Legal Standards ................................................................................... 25
`
`VII. STATEMENT OF REASONS FOR RELIEF REQUESTED ...................... 25
`
`
`
`Claim 43 is Unpatentable as being Obvious Over the
`Radermacher ‘157 Publication and the Radermacher Article in
`View of the Androphy Patent .............................................................. 25
`
`VIII. CONCLUSION .............................................................................................. 34
`
`
`
`
`
`
`
`
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`ii
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
`
`
`TABLE OF AUTHORITIES
`
`
`
`Statutes
`
`35 U.S.C. § 102…………………………………………………………passim
`
`35 U.S.C. § 103…………………………………………………………passim
`
`35 U.S.C. § 112………...…………………………………………………….24
`
`35 U.S.C. §§ 311-319………...……………………………………………….1
`
`35 U.S.C. § 314(a) ………...…………………………..…………………….25
`
`
`Rules
`
`37 C.F.R. § 42.100 et seq…...…………………………………………………1
`
`37 C.F.R. § 42.100(b) …...…………………………………………..………24
`
`
`Cases
`
`KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S.Ct. 1727
`(2007) …...………………………………………………………….…….27, 32
`
`
`
`
`iii
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
`
`
`LIST OF EXHIBITS
`
`
`Exhibit 1001:
`
`Exhibit 1002:
`
`Exhibit 1003:
`
`Exhibit 1004:
`
`Bonutti U.S. Patent 7,806,896 (“Bonutti Patent”)
`
`Copy of Declaration of Arthur G. Erdman, Ph.D, from
`instituted IPR2014-00321 (“Erdman Decl.”)
`
`Radermacher PCT International Publication No. WO 93/25157
`(“Radermacher ’157 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:
`
`Reserved
`
`Exhibit 1007:
`
`Reserved
`
`Exhibit 1008:
`
`Reserved
`
`Exhibit 1009:
`
`Exhibit 1010:
`
`Exhibit 1011:
`
`Exhibit 1012:
`
`Decision instituting inter partes review in IPR2014-00321
`(“Decision”)
`
`Second Declaration of Arthur G. Erdman, Ph.D. (“2nd Erdman
`Decl.”)
`
`Opening Brief in Support of Defendants’ Joint Motion to Stay
`Litigation Pending Inter Partes Review filed in Bonutti Skeletal
`Innovations LLC v. Zimmer Holdings, Inc. & Zimmer, Inc., No.
`1:12-cv-01107-GMS, Dkt. No. 36 (Jan. 22, 2014 D. Del.)
`
`Memorandum and Order Granting Defendants’ Joint Motion to
`Stay Litigation Pending Inter Partes Review filed in Bonutti
`Skeletal Innovations LLC v. Zimmer Holdings, Inc. & Zimmer,
`Inc., No. 1:12-cv-01107-GMS, Dkt. No. 45 (Apr. 7, 2014 D.
`
`
`
`
`
`iv
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`

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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
`
`
`
`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
`
`dependent claim 43 of the Bonutti U.S. Patent 7,806,896 (“Bonutti Patent”) (Ex.
`
`1001).
`
`This is the second petition filed by Petitioners in connection with the Bonutti
`
`Patent. The first such petition (“First Petition”) is the subject of Inter Partes
`
`Review No. IPR2014-00321, in which the Board issued a Decision instituting inter
`
`partes review on June 2, 2014 (the “Instituted IPR”). The Decision in the
`
`Instituted IPR is attached as Exhibit 1009. In that Decision, the Board instituted
`
`trial on some, but not all, of the claims subject to the First Petition. In particular,
`
`the Board instituted trial with respect to claims 40-42 and 44-47, but did not
`
`institute a trial on claim 43 that depends from claim 40. The Board did not
`
`institute a trial on the obviousness-based ground presented in connection with
`
`dependent claim 43 because according to the Board, the First Petition did not
`
`“show it would have been obvious to combine the teachings of those references in
`
`a particular manner to arrive at the claimed invention.” Ex. 1009, p. 9.
`
`This Petition requests inter partes review of only claim 43, and is based on
`
`prior art presented in the First Petition. A motion for joinder accompanies this
`
`Petition. Petitioners request that the Board grant this Petition and institute trial.
`
`
`
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`1
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
`
`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
`
`
`
`As noted above, this is the second petition for inter partes review filed by
`
`Petitioners in connection with the Bonutti Patent. The first such petition is the
`
`subject of Inter Partes Review No. IPR2014-00321, in which the Board issued a
`
`Decision instituting inter partes review on June 2, 2014 (“Instituted IPR”).
`
`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 complaint was
`
`served on January 4, 2013. The Case No. of the lawsuit is 1:12-cv-01107-GMS.
`
`That lawsuit was stayed by a decision dated April 7, 2014, and remains stayed.
`
`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.
`
`The Board issued a Decision instituting inter partes review, in part, in IPR2014-
`
`00191 on June 2, 2104. The Board issued a Decision denying institution of inter
`
`
`
`
`2
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
`
`partes review in IPR2014-00311 on June 4, 2014. Petitioners are filing a second
`
`petition for inter partes review of U.S. patent 7,837,736 on the same date as this
`
`Petition.
`
`Petitioners are aware of Inter Partes Review Nos. IPR2013-00629 (now
`
`instituted) and IPR2014-00354 (now instituted) which are also directed to U.S.
`
`patent 7,806,896 that is the subject of this Petition and brought other petitioners.
`
`
`
`Petitioners are also aware of Inter Partes Review Nos. IPR2013-00605,
`
`IPR2013-00620 and IPR2013-00621 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
`
`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
`
`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.
`
`
`
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`3
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
`
`
`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. As noted above in Section I.B., the complaint in
`
`the related litigation was served on January 4, 2013. However, this petition is
`
`being timely filed with a motion for joinder with Inter Partes Review No.
`
`IPR2014-00321, and is proper pursuant to 35 U.S.C. § 315(b) and (c) and 37
`
`C.F.R. § 42.122(b). Samsung Elecs. Co. Ltd. v. Va. Innovation Scis., Inc.,
`
`IPR2014-00557, Paper 10, at 14-16 (P.T.A.B. June 13, 2014); Sony Corp. v.
`
`Yissum Res. & Dev. Co. of the Hebrew Univ. of Jerusalem, IPR2013-00326, Paper
`
`15, at 3-4 (P.T.A.B. Sept. 24, 2013); Dell Inc. v. Network-1 Sec. Solutions, Inc.,
`
`IPR2013-00385, Paper 17, at 4-6 (P.T.A.B. July 29, 2013); Microsoft Corp. v.
`
`Proxyconn, Inc., IPR2013-00109, Paper 15, at 3-4 (P.T.A.B. Feb. 25, 2013).
`
`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
`
`
`
`
`4
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
`
`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 dependent claim 43 of the Bonutti Patent
`
`be canceled based on the following ground.1 A full statement of the reasons for
`
`this request is presented in later sections of this Petition. This ground is supported
`
`by the Declaration of Arthur G. Erdman, Ph.D. (“Erdman Decl.,” Ex. 1002) and
`
`the Second Declaration of Arthur G. Erdman, Ph.D. (“2nd Erdman Decl.,” Ex.
`
`1010).
`
`•
`
`Ground: Claim 43 is unpatentable under 35 U.S.C. § 103 as being
`
`obvious over the Radermacher ’157 Publication (Ex. 1003) and the Radermacher
`
`Article (Ex. 1004) in view of the Androphy Patent (Ex. 1005).
`
`III. OVERVIEW OF KNEE ANATOMY AND KNEE REPLACEMENT
`
`The challenged claim of the Bonutti Patent relates generally to joint repair
`
`and replacement – surgical procedures known as joint arthroplasty. More
`
`particularly, the challenged claim relates to a method for implanting a prosthesis
`
`
`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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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
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`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.
`
`The following overview of knee anatomy is substantially the same as that
`
`presented in the First Petition.
`
`A. Knee Anatomy
`
`
`
`A simplified description of the components and operation of the knee that
`
`are relevant to the challenged claim of the Bonutti Patent can be provided with
`
`reference to the following illustration of a human knee joint.
`
`
`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
`
`
`
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`6
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
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`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.
`
`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
`
`
`
`The following overview of knee replacement surgery is substantially the
`
`same as that presented in the First Petition. Features of a typical replacement knee
`
`
`
`
`7
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
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`implant or prosthesis that are pertinent to the challenged claim 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,
`
`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.
`
`
`
`
`8
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
`
`
`
`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
`
`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
`
`
`
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
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`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
`
`As a preliminary matter, Petitioners note that the following overview of the
`
`Bonutti Patent is substantially the same as that presented in the First Petition.
`
`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
`
`claim of the patent, however, is directed to the use of instruments that help a
`
`surgeon resect the bones of that patient in a precise manner.
`
`
`
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
`
`
`In particular, independent claim 402 from which the challenged dependent
`
`claim 43 depends 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.” In the Decision in the Instituted IPR, the Board ordered inter
`
`partes review of claim 40 under 35 U.S.C. § 103 on the ground that the claim is
`
`obvious in view of the Radermacher ’157 Publication and the Radermacher
`
`Article. Ex. 1009, p. 11.
`
`Challenged claim 43 depends from claim 40 and further defines the guide
`
`surface of the cutting guide as having “a width less than the width of the cut
`
`portion of the bone.”
`
`
`
`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
`
`
`2 Patent Owner filed a statutory disclaimer of claim 40 of the Bonutti Patent. See
`
`e.g., Patent Owner’s notice of the disclaimer filing (paper no. 15) in the Instituted
`
`IPR. This Petition, however, challenges claim 43, which depends from claim 40,
`
`and thus incorporates all the limitations of that claim.
`
`
`
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`11
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
`
`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.
`
`
`
`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
`12
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
`
`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
`
`claim 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 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.
`
`The Decision in the Instituted IPR points to the extramedullary alignment
`
`guide 504 upon which the tibial resection (cutting) guide 500 (Ex. 1001, col. 44, ll.
`
`21-30; Figs. 37, 38) is placed in connection with its claim construction of the
`
`“alignment guide” and “cutting guide” reciting two distinct elements. Ex. 1009, p.
`
`5. However, there is no description in the Bonutti Patent regarding the
`
`extramedullary alignment guide being custom fabricated for the patient based on
`
`patient imaging information.
`
`Regarding the claim 43 limitation of the guide surface having a width that is
`
`less than the width of the width of the cut portion of the bone, the Bonutti Patent
`
`
`
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`13
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
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`discloses several cutting guides having widths that are less that the widths of the
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`cut bone. A tibia resection guide 500 having a guide surface width that is less than
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`the width of the bone to be cut is shown in Fig. 38 and described at col. 45, ll. 53-
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`62. A femoral cutting guide 750 that extends only part way across the distal end
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`portion of the femur is shown in Fig. 53 and described at col. 69, ll. 42-63. A
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`femoral cutting guide 800 having a guide surface extent that is less than the extent
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`of the distal end cut to be formed on the femur is sown in Fig. 54 and described at
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`col. 71, ll. 3-16. However, there is no description of these cutting guides being
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`referenced with respect to a custom fabricated alignment guide.
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`B. Claim 40
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`Claim 40, the independent claim from which challenged claim 43 depends,
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`recites a method of replacing at least a portion of a joint in a patient. The
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`limitations of claim 40 are reproduced below:
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`“[1] obtaining an alignment guide positionable on a bone using references
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`derived independently of an intramedullary device, wherein the alignment guide
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`is custom fabricated for the patient based on patient imaging information;
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`[2] positioning the alignment guide in relation to the surface of an unresected
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`bone of the joint;
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`[3] referencing a cutting guide with respect to the alignment guide; and
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`Inter Partes Review No. Unassigned
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`[4] cutting the unresected bone of the joint for the first time, by moving a
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`cutting tool along a guide surface of the cutting guide.” (emphasis added).
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`
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`C. Claim 43
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`Claim 43 depends from claim 40 and recites “wherein the guide surface has
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`a width less than the width of the cut portion of the bone.”
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`D.
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`Priority Date of the Bonutti Patent
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`
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`The Bonutti Patent claims priority to a number of other U.S. patent
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`applications. Based on a review of these earlier applications, application no.
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`09/941,185, filed on August 28, 2001 (now patent 6,702,821), appears to be the
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`earliest that includes the holographic image approach discussed above and
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`described with reference to Fig. 55 in the Bonutti Patent. The priority date for the
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`claims of the Bonutti Patent challenged in this Petition is no earlier than August 28,
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`2001. The Petitioners reserve the right to respond accordingly in the event the
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`Patent Owner alleges an earlier date of invention.
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`V. OVERVIEW OF THE PRIOR ART RELIED UPON FOR THE
`CHALLENGE
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`A.
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`The Radermacher ’157 Publication
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`
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`The following overview of the Radermacher ’157 Publication is
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`substantially the same as that presented in the First Petition.
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`Inter Partes Review No. Unassigned
`Petition For Inter Partes Review of U.S. Patent 7,806,896; Filed: June 30, 2014
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`The Radermacher ’157 Publication (Ex. 1003) relates to the treatment of
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`osseous structures, such as cutting bones forming a joint as part of a joint
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`replacement operation. The Radermacher ’157 Publication published on
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`December 23, 1993, and is prior art to the Bonutti patent under 35 U.S.C. § 102(b).
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`The Radermacher ’157 Publication was cited during prosecution of the Bonutti
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`patent, but was not relied upon by the examiner or distinguished by the patentee.
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`
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`The Radermacher ’157 Publication acknowledges that, in joint arthroscopy
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`operations, it is important to precisely resect the bone and describes several known
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`techniques for accurately aligning a cutting tool for those resecting cuts. For
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`example, the Radermacher ’157 Publication notes the use of a “laser beam” to
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`“display cutting paths” on the bone. Ex. 1003, p. 8.
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`The Radermacher ’157 Publication also describes how, nearly a decade
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`before the priority date of the Bonutti Patent, surgeons used “standard tool guides,”
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`such as “saw templates,” to precisely resect the bones during a joint-replacement
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`operation. Ex. 1003, pp. 11, 13. One exemplary “standard tool guide” expressly
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`identified in the Radermacher ’157 Publication is the “cutting” template described
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`in the Androphy U.S. Patent 4,567,885 (Ex. 1005, discussed in more detail below).
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`Ex. 1003, p. 2. In particular, at page 2, the Radermacher ’157 Publication states
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`“[f]or some interventions, standard tool guides have been provided. These are
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`Inter Partes Review No. Unassigned
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`mostly cutting, boring or sinking templates for preparing and/or fixing the seat of a
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`knee or hip prosthesis (e.g., [the Androphy patent] US 4,567,885 ….”
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`While those “standard” cutting guides are useful for guiding a cutting tool
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`(e.g., a saw or drill) along a particular path, it is important that those cutting guides
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`be correctly placed with respect to the bone. To address that issue, the
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`Radermacher ’157 Publication discloses an “individual template” for positioning
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`tool guides, including the “standard” tool guides such as that shown in the
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`Androphy Patent, with respect to the bone. That individual template incorporates a
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`surface created as a customized, “three-dimensional negative mold” of the “natural
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`(i.e. not pre-treated) surface” of the patient’s bone. Ex. 1003, p. 12. Because each
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`patient’s bone has a complex surface structure, using a three-dimensional negative
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`mold ensures that the individual template will fit onto the uncut bone surface “in
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`exclusively one clearly defined position….” Ex. 1003, pp. 10-11. To create the
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`individual template and its negative mold, “split images” are taken of the targeted
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`bone, and those images are used to generate “the three-dimensional shape of the
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`osseous structure and the surface thereof.” Ex. 1003, p.10. The individual
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`template is then formed to “cop[y] the surface of the osseous structure” to ensure
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`its unique fit. Ex. 1003, p. 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. 1003, p. 11. Through those engagement points, standard tool guides can be
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`placed at a particular position and orientation. Ex. 1003, pp. 11, 12. The
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`Radermacher ’157 Publication also teaches that cutting guides can be incorporated
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`into the individual template itself. Ex. 1003, page 13. 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, p. 11.
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`
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`The Radermacher ’157 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, p. 30. Of particular relevance to the challenge bases
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`herein, the Radermacher ’157 Publication teaches that the individual template can
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`be used “for preparation of a prosthesis seat of a knee-joint head prosthesis.” Ex.
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`1003, p. 19.
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`When discussing knee-joint replacement operations, the Radermacher ’157
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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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`
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`In sum, the Radermacher ’157 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 bef