DOCKET NO.: 0286868-00188
`Filed on behalf of Smith & Nephew, Inc.
`By: David L. Cavanaugh, Reg. No. 36,476
`
`Michael H. Smith, Reg. No. 71,190
`
`Wilmer Cutler Pickering Hale and Dorr LLP
`
`1875 Pennsylvania Ave., NW
`
`Washington, DC 20006
`Tel: (202) 663-6000
`Email: David.Cavanaugh@wilmerhale.com
`MichaelH.Smith@wilmerhale.com
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________________________________
`
`SMITH & NEPHEW, INC.
`Petitioner
`
`
`
`v.
`
`Patent Owner of
`U.S. Patent No. 7,806,896 to Peter M. Bonutti
`
`IPR Trial No. TBD
`
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 7,806,896
`UNDER 35 U.S.C. § 312 AND 37 C.F.R. § 42.104
`
`
`
`
`
`
`
`

`

`
`
`I.
`
`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`TABLE OF CONTENTS
`
`MANDATORY NOTICES ............................................................................. 1
`
`A.
`
`B.
`
`C.
`
`D.
`
`Real Party-in-Interest ............................................................................ 1
`
`Related Matters ..................................................................................... 1
`
`Counsel .................................................................................................. 1
`
`Service Information ............................................................................... 2
`
`II.
`
`CERTIFICATION OF GROUNDS FOR STANDING .................................. 2
`
`III. OVERVIEW OF CHALLENGE AND RELIEF REQUESTED .................... 2
`
`A.
`
`B.
`
`Prior Art Patents and Printed Publications ............................................ 2
`
`Grounds for Challenge .......................................................................... 4
`
`IV. CLAIM CONSTRUCTION ............................................................................ 5
`
`V. OVERVIEW OF KNEE ANATOMY AND KNEE REPLACEMENT ......... 7
`
`A. Anatomical Terms of Location ............................................................. 8
`
`B.
`
`C.
`
`D.
`
`Relevant Knee Anatomy ....................................................................... 8
`
`Knee Replacement Surgery ................................................................... 9
`
`Computer Assisted Knee Surgery ....................................................... 14
`
`VI. SUMMARY OF THE ’896 PATENT AND RELEVANT FILE
`HISTORY ...................................................................................................... 15
`
`A.
`
`B.
`
`C.
`
`D.
`
`The Challenged Claims of the ’896 Patent ......................................... 16
`
`Summary of Portion of the Specification Related to
`Challenged Claim ................................................................................ 18
`
`The Effective Filing Date of the ’896 Issued Claims ......................... 21
`
`Summary of the Prosecution History of the ’896 Patent .................... 21
`
`
`
`
`
`

`

`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`
`VII. THE PRIOR ART RENDERS THE CHALLENGED CLAIMS
`UNPATENTABLE ........................................................................................ 22
`
`A.
`
`The References .................................................................................... 23
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`Delp Article ............................................................................... 23
`
`Delp ’018................................................................................... 24
`
`Stulberg ..................................................................................... 24
`
`Radermacher ’157 ..................................................................... 25
`
`Radermacher Article ................................................................. 25
`
`Turner ........................................................................................ 26
`
`Scorpio ...................................................................................... 26
`
`VIII. IDENTIFICATION OF HOW THE CHALLENGED CLAIMS ARE
`UNPATENTABLE ........................................................................................ 26
`
`A.
`
`Independent Claim 1 ........................................................................... 27
`
`1.
`
`2.
`
`3.
`
`Claim 1 is Obvious Over the Delp Article in View
`of Any One of Turner or Scorpio .............................................. 27
`
`Claim 1 is Obvious Over Delp ’018 in View of
`Any One of Turner or Scorpio .................................................. 37
`
`Claim 1 is Obvious Over Stulberg in View of Any
`One of Turner or Scorpio .......................................................... 43
`
`B.
`
`Independent Claim 13 ......................................................................... 47
`
`1.
`
`2.
`
`Claim 13 is Anticipated by Radermacher ’157 ......................... 47
`
`Claim 13 is Obvious Over the Radermacher
`Article in View of Any One of Turner or Scorpio ................... 53
`
`IX. CONCLUSION ............................................................................................. 60
`
`
`
`
`
`ii
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`

`

`
`
`
`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`TABLE OF AUTHORITIES
`
`
`
`
`FEDERAL CASES
`In re ICON Health and Fitness, Inc.,
`496 F.3d 1374 (Fed. Cir. 2007) ............................................................................ 5
`
`Page(s)
`
`STATUTES
`
`35 U.S.C. § 102 .......................................................................................................... 4
`
`35 U.S.C. § 102(b) ................................................................................................. 3, 4
`
`35 U.S.C. § 103 .......................................................................................................... 4
`
`35 U.S.C. § 112 .......................................................................................................... 5
`
`35 U.S.C. § 314(a) ..................................................................................................... 4
`
`OTHER AUTHORITIES
`
`Rule 42.22(a)(1) ......................................................................................................... 2
`
`Rule 42.100(b) ........................................................................................................... 5
`
`Rule 42.104(a) ............................................................................................................ 2
`
`Rule 42.104(b)(4)-(5) ............................................................................................... 26
`
`Rule 42.104(b)(1)-(2) ................................................................................................. 2
`
`77 Fed. Reg. 48764 (Aug. 14, 2012) ......................................................................... 5
`
`
`
`
`
`iii
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`

`

`I. MANDATORY NOTICES
`
`A. Real Party-in-Interest
`
`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`Smith & Nephew, Inc. (“Petitioner”) is the real party-in-interest and submits
`
`this inter partes review Petition (“Petition”) for review of certain claims of U.S.
`
`Patent No. 7,806,896 (“the ’896 patent”).
`
`B. Related Matters
`
`The following litigation matter would affect or be affected by a decision in
`
`this proceeding: Bonutti Skeletal Innovations LLC v. Smith & Nephew, Inc., Civil
`
`Action No. 12-1111-GMS (D. Del.). The litigation involves six patents: the ’896
`
`patent and U.S. Patent Nos. 5,980,559; 6,702,821; 7,087,073; 7,749,229; and
`
`8,133,229. The ’896 patent is the subject of this Petition. Separate petitions for
`
`inter partes review of the other patents above are also being filed. Because the
`
`technology and disclosure in the patents are similar and for the sake of
`
`administrative efficiency and consistent outcome, Petitioner requests that the
`
`Patent Trial and Appeals Board (“PTAB”) have a single Administrative Panel
`
`address these inter partes reviews.
`
`C. Counsel
`
`Lead Counsel: David L. Cavanaugh (Registration No. 36,476)
`
`Backup Counsel: Michael H. Smith (Registration No. 71,190)
`
`
`
`
`1
`
`

`

`D.
`
`Service Information
`
`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`Email: David.Cavanaugh@wilmerhale.com
`
`Post and hand delivery: Wilmer Cutler Pickering Hale and Dorr LLP
`
`1875 Pennsylvania Ave., NW
`
`
`
`Washington, DC 20006
`
`Telephone: 202-663-6025
`
`
`
`Facsimile: 202-663-6363
`
`II. CERTIFICATION OF GROUNDS FOR STANDING
`
`Petitioner certifies pursuant to Rule 42.104(a) that the patent for which
`
`review is sought is available for inter partes review and that Petitioner is not
`
`barred or estopped from requesting an inter partes review challenging the patent
`
`claims on the grounds identified in this Petition.
`
`III. OVERVIEW OF CHALLENGE AND RELIEF REQUESTED
`
`Pursuant to Rules 42.22(a)(1) and 42.104(b)(1)-(2), Petitioner challenges
`
`claims 1 and 13 of the ’896 patent (Ex. 1001).
`
`A.
`
`Prior Art Patents and Printed Publications
`
`Petitioner relies upon the following patents and printed publications:
`
`1. Scott L. Delp, et al., “Computer Assisted Knee Replacement,” 354 Clinical
`
`Orthopaedics and Related Research, pp. 49-56 (1998) (“Delp Article” (Ex.
`
`
`
`
`2
`
`

`

`1003)), which has a publication date of 1998, and is prior art to the ’896
`
`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`patent under 35 U.S.C. § 102(b).1
`
`2. U.S. Patent No. 5,871,018 (“Delp ’018” (Ex. 1004)), which has a filing date of
`
`June 6, 1997, and an issue date of February 16, 1999, and is prior art to the
`
`’896 patent under 35 U.S.C. § 102(b).
`
`3. S. David Stulberg, et al., “Computer-Assisted Total Knee Replacement
`
`Arthroplasty,” 10(1) Operative Techniques in Orthopaedics, pp. 25-39 (Jan.
`
`2000) (“Stulberg” (Ex. 1005)), which has a publication date of Jan. 2000, and
`
`is prior art to the ’896 patent under 35 U.S.C. § 102(b).
`
`4.
`
`International Patent Application Publication No. WO 93/25157
`
`(“Radermacher ’157” (Ex. 1007)), which has an international filing date of
`
`June 17, 1993, and an international publication date of December 23, 1993,
`
`and is prior art to the ’896 patent under 35 U.S.C. § 102(b).
`
`5. Klaus Radermacher, et al., “Computer Assisted Orthopaedic Surgery With
`
`Image Based Individual Templates,” 354 Clinical Orthopaedics and Related
`
`Research, pp. 28-38 (1998) (“Radermacher Article” (Ex. 1006)), which has a
`
`
`1 The ’896 patent was issued prior to the America Invents Act (“AIA”). Therefore,
`
`Petitioner has used the pre-AIA statutory framework to refer to the prior art.
`
`
`
`
`3
`
`

`

`publication date of 1998, and is prior art to the ’896 patent under 35 U.S.C. §
`
`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`102(b).
`
`6. Roderick H. Turner, Richard Matzan, and Yousif I. Hamati, “Geometric and
`
`Anametric Total Knee Replacement,” in Total Knee Replacement (A.A.
`
`Savastano, M.D. ed. 1980) (“Turner” (Ex. 1008)), which has a publication
`
`date of 1980, and is prior art to the ’896 patent under 35 U.S.C. § 102(b).
`
`7. Stryker Howmedica Osteonics, “Scorpio Single Axis Total Knee System:
`
`Passport A.R. Surgical Technique” (“Scorpio” (Ex. 1009)), which has a
`
`publication date of May 2000, and is prior art to the ’896 patent under 35
`
`U.S.C. § 102(b).
`
`B. Grounds for Challenge
`
`Petitioner requests cancellation of claims 1 and 13, the challenged claims, as
`
`unpatentable under 35 U.S.C. § 102 and 35 U.S.C. § 103.
`
`This Petition, supported by the declaration of Dr. Jay Mabrey (“Mabrey
`
`Declaration” or “Mabrey Decl.” (Ex. 1002)) filed with this Petition, demonstrates
`
`that there is a reasonable likelihood that Petitioner will prevail with respect to at
`
`least one of the challenged claims and that each of the challenged claims is
`
`unpatentable for the reasons cited in this Petition. See 35 U.S.C. § 314(a).
`
`
`
`
`4
`
`

`

`IV. CLAIM CONSTRUCTION
`
`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`
`
`A claim in inter partes review is given the “broadest reasonable construction
`
`in light of the specification.” 37 C.F.R. § 42.100(b). Any claim term that lacks a
`
`definition in the specification is therefore also given a broad interpretation.2 In re
`
`ICON Health & Fitness, Inc., 496 F.3d 1374, 1379 (Fed. Cir. 2007). The
`
`following discussion proposes constructions of and support therefore of those
`
`terms in the claims listed below. Any claim terms not included in the following
`
`discussion are to be given their broadest reasonable interpretation in light of the
`
`specification as commonly understood by those of ordinary skill in the art.
`
`Moreover, should the Patent Owner, in order to avoid the prior art, contend that the
`
`claims have a construction different from their broadest reasonable interpretation,
`
`the appropriate course is for the Patent Owner to seek to amend the claims to
`
`expressly correspond to its contentions in this proceeding. See 77 Fed. Reg. 48764
`
`(Aug. 14, 2012). Any such amendment would only be permissible if the proposed
`
`amended claims comply with 35 U.S.C. § 112.
`
`Claim 1 recites a “cutting guide” and a “guide surface.” These terms are not
`
`defined in the ’896 patent. The ’896 patent specification describes cutting guides
`
`
`2 The present analysis applies the “broadest reasonable construction” standard. A
`
`construction under, e.g., the standard applied in a District Court may be different.
`
`
`
`
`5
`
`

`

`such as the “anterior resection guide 138” and the “femoral cutting guide 210.”
`
`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`’896 patent, col. 38, ll. 9-18 (Ex. 1001). The specification describes these cutting
`
`guides as having “guide surfaces,” and describes the “guide surfaces” as guiding
`
`cutting instruments. E.g., ’896 patent, col. 36, ll. 22-24 (“anterior resection guide
`
`138 . . . has a guide surface 178”); col. 24, ll. 57-59 (“cuts are made by moving the
`
`saw blade 170 or other cutting tool along guide surfaces on the femoral cutting
`
`guide”) (Ex. 1001). Therefore, the terms “cutting guide” and “guide surface”
`
`should be given their broadest reasonable interpretations and should be construed
`
`to mean a “guide that has a guide surface” and “a surface that guides a cutting
`
`instrument,” respectively. Mabrey Decl. ¶ 15 (Ex. 1002).
`
`
`
`Claim 13 recites a “customized cutting guide.” This term is not defined in
`
`the ’896 patent. The Petitioner proposes that the term “customized cutting guide”
`
`should be given its broadest reasonable interpretation and should be construed to
`
`mean “a cutting guide modified for a specific patient.” See ’896 patent, col. 108,
`
`ll. 19-21 (Ex. 1001); see also, e.g., The New Oxford American Dictionary (2d ed.
`
`2005) (defining “customize” as “modify (something) to suit a particular individual
`
`or task”); Webster’s New College Dictionary (2007); The American Heritage
`
`College Dictionary (3d ed. 1993) (Exs. 1010, 1011, 1012); Mabrey Decl. ¶ 16 (Ex.
`
`1002).
`
`
`
`
`6
`
`

`

`V. OVERVIEW OF KNEE ANATOMY AND KNEE REPLACEMENT
`
`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`The challenged claims of the ’896 patent relate to methods for knee
`
`replacement surgery, also known as knee arthroplasty.
`
`Generally, there are two types of knee replacement surgeries: total knee and
`
`partial knee replacement. Mabrey Decl. ¶ 19 (Ex. 1002). During either type of
`
`knee replacement, an orthopedic surgeon replaces either a portion of or all of a
`
`damaged knee with an artificial device (also known as a prosthesis or an implant).
`
`Id. Although a total knee arthroplasty (“TKA”) is the most common procedure,
`
`some people can benefit from replacing only a portion of the knee, such as the
`
`medial femoral-tibial joint. Id. This partial replacement is sometimes called a
`
`unicondylar knee arthroplasty (“UKA”). Id.
`
`Knee replacement was not new when the ’896 patent was filed. Id. ¶ 20 (Ex.
`
`1002). Some elementary background in the anatomical terms of location, the knee
`
`anatomy, and the surgical procedure is helpful to understand fully the claim
`
`limitations in the challenged claim and to appreciate how the prior art renders the
`
`claim unpatentable. Id.
`
`
`
`
`7
`
`

`

`A. Anatomical Terms of Location
`
`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`The following standard anatomical terms are relevant to knee replacement:
`
`• Anterior – Front of the body
`
`• Posterior – Rear of the body
`
`• Medial – Toward the center of the body
`
`• Lateral – Left and right of the body
`
`• Proximal – End of an appendage closer to torso
`
`• Distal – End of an appendage further from torso
`
`Mabrey Decl. ¶ 21 (Ex. 1002).
`
`B. Relevant Knee Anatomy
`
`At a simple conceptual level, the knee works like a modified hinge on a
`
`door. Id. ¶ 22 (Ex. 1002). Bending of the
`
`knee is called “flexion” and straightening of
`
`the knee is called “extension.” Id. The knee is
`
`more complex than a simple hinge and
`
`actually rotates around its central axis as it
`
`flexes and extends. Id.
`
`The illustration to the right shows the
`
`components of the knee. Id. ¶ 23 (Ex. 1002).
`
`The knee is a major weight-bearing joint that is held together by muscles,
`
`8
`
`
`

`

`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`ligaments, and soft tissue. Id. Cartilage inside the joint provides shock absorption,
`
`which is used to walk, run, lift, climb stairs, etc. Id.
`
`A human knee is comprised of four main components: bones, ligaments,
`
`cartilage, and tendons. Id. ¶ 24 (Ex. 1002). With respect to bones, a knee is made
`
`up of the thighbone (femur), the shinbone (tibia), the fibula, and the kneecap
`
`(patella). Id. ¶ 25 (Ex. 1002). The thighbone and shinbone come together to form
`
`a hinge. Id. Two major supporting ligaments of the knee are the medial and lateral
`
`collateral ligaments. Id. They attach to the medial and lateral femoral
`
`epicondyles. Id. The epicondyles serve as reference points for positioning total
`
`knee implants during surgery. Id. The features are shown below:
`
`
`
`Illustration of Bent Knee with Patella Cut Away from Thighbone
`
`C. Knee Replacement Surgery
`
`When a knee has been damaged by a disease like osteoarthritis, knee
`
`replacement surgery can replace the damaged portions with artificial components.
`
`
`
`
`9
`
`

`

`Mabrey Decl. ¶ 29 (Ex. 1002). Before the surgeon can begin the procedure,
`
`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`however, the parts of the knee to be replaced must be exposed. Id. A surgeon will
`
`expose the operative areas by first making an incision through the patient’s skin.
`
`Id. The surgeon will then typically access the operative area by moving the patella
`
`out of the trochlear groove to expose the condyles and the intercondyle notch. Id.
`
`The surgeon offsets the patella to the side of the knee by either pushing it over
`
`(displacing it laterally) without flipping it over, or by lifting the patella off of the
`
`knee and rotating it to the side such that the articulating surface is no longer facing
`
`the femur (referred to as everting). Id. Once the surgeon offsets the patella, unless
`
`she is resurfacing the patella, the surgeon will maintain the patella in the offset
`
`position, so that she has access to the bones of the knee during the surgery. Id.
`
`Once the knee is exposed, the surgeon will conduct the replacement through
`
`four phases: preparing the bone; positioning the implant; resurfacing the patella;
`
`and inserting a spacer. Id. ¶ 30 (Ex. 1002). The first two phases are discussed
`
`below.
`
`Preparing the Bone – The surgeon removes the damaged cartilage surfaces
`
`at the ends of the femur and tibia and a small amount of underlying bone. Id. ¶ 31
`
`(Ex. 1002). The figures below show an example of the cuts a surgeon would
`
`typically make to a femur during surgery and the results of those cuts.
`
`
`
`
`10
`
`

`

`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`
`Illustrations of Knee Resection Cuts (Fig. 16) and Resected Knee (Fig. 17)
`
`
`
`U.S. Patent No. 4,502,483, filed March 9, 1983 (“Lacey ’483”), Figs. 16 & 17 (Ex.
`
`1013)); Mabrey Decl. ¶ 31 (Ex. 1002).
`
`To help ensure that cuts are made accurately, surgeons typically use cutting
`
`guides with a guide surface that guides the saw used to cut (or “resect”) the bone.
`
`Mabrey Decl. ¶ 32 (Ex. 1002). Cutting guides, also known as resection guides or
`
`guide members, come in many different shapes and sizes. Id. A few illustrative
`
`examples of prior art cutting guides are shown below:
`
`
`
`Illustrative Examples of Prior Art Cutting Guides
`
`
`
`
`
`
`
`
`11
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`

`

`Smith & Nephew Genesis Uni, p. 16; Figs. 29 (Ex. 1018) (top left); Lackey ’803,
`
`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`Fig. 11 (Ex. 1019) (assigned to Smith & Nephew Richards) (top center); Richards,
`
`p. 3 (Ex. 1020) (top right); Turner, Fig. 8; p. 181 (Ex. 1008) (bottom left);
`
`Radermacher ’157, Fig. 13a (Ex. 1007) (bottom center); Keblish, Fig. 10 (Ex.
`
`1021) (bottom right); Mabrey Decl. ¶ 32 (Ex. 1002).
`
`As shown above, in some cutting guides, such as the Smith & Nephew
`
`Genesis Uni, the guide surface is a slot. Mabrey Decl. ¶ 33 (Ex. 1002). In other
`
`cutting guides, such as the Turner example, the cutting surface is provided without
`
`a slot. Id. Other cutting guides, such as the Radermacher example, contain open
`
`guide surfaces (e.g., 20b) and a slot (e.g., 20c). Whether a slot is used is a matter
`
`of surgeon preference. Id. Some surgeons prefer cutting guides with slots, which
`
`provide greater guidance of the saw blade, whereas other surgeons prefer open
`
`cutting surfaces, which are easier to clean, generate less metallic debris, and make
`
`it easier for the surgeon to adjust the cut. Id. The design choice between slots and
`
`open cutting guides was within the level of ordinary skill to design and modify
`
`when the ’896 patent was filed. Id. The placement and extent of the cutting
`
`surface is also within the level of ordinary skill. Id. Each had known attributes
`
`and predictable results. Id.
`
`Initially, surgeons positioned cutting guides by hand. Id. ¶ 34 (Ex. 1002).
`
`Beginning in the 1960’s and 1970’s, surgeons started using mechanical alignment
`
`
`
`
`12
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`

`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`guides to assure that cutting guides were properly aligned with the leg when placed
`
`on the bone. Id. Two common types of alignment guides are intramedullary
`
`alignment rods, which are inserted into the medullary canal (bone marrow cavity)
`
`of the bone and extramedullary alignment rods, which are placed externally along
`
`the medullary canal of the bone.
`
`
`Illustrations of an Intramedullary Alignment Device (Left) and an
`Extramedullary Alignment System (Right)
`
`Stulberg, p. 32, Figs. 10-11 (Ex.1005); Mabrey Decl. ¶ 34 (Ex. 1002).
`
`More recently, during the 1990’s, surgeons began using computer assisted
`
`techniques to guide the placement of cutting blocks and create customized cutting
`
`guides adapted to fit a specific patient’s bone. Mabrey Decl. ¶ 35 (Ex. 1002).
`
`Positioning the Metal Implants – The surgeon replaces the removed cartilage
`
`and bone with metal components that recreate the surface of the joint. Id. ¶ 36 (Ex.
`
`1002). Before implanting a metal implant, the surgeon will typically test the fit of
`
`the implant with a trial prosthesis that is the same size as the metal implant, but is
`
`
`
`
`13
`
`

`

`not implanted. Id. After confirming the fit with the trial prostheses, the metal
`
`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`implants may be cemented or “press-fit” into the bone. Id.
`
`D. Computer Assisted Knee Surgery
`
`Computer-assisted knee replacement was not new when the ’896 patent was
`
`filed. Id. ¶ 40 (Ex. 1002); ’896 patent, col. 42, ll. 30-39 (Ex. 1001)
`
`(acknowledging image-guided surgery systems were “known” and “commercially
`
`available”). One approach developed in the 1990’s uses preoperative scanning
`
`techniques (e.g., MRI, CT-scan, etc.) to visualize an individual patient’s bony knee
`
`anatomy. Mabrey Decl. ¶ 40 (Ex. 1002). Other systems utilize bony landmarks
`
`and centers of rotation acquired at the time of surgery to establish proper axes of
`
`alignment. Id. These techniques permit the surgeon to identify important
`
`landmarks that ensure that the implants are properly installed. Id. In addition,
`
`those techniques that utilize scans can be used to create customized cutting blocks
`
`that interface precisely with the patient’s bony anatomy and ensure accurate
`
`placement of the implants. Id. These were developed due to the failings of
`
`standard mechanical techniques:
`
`Mechanical alignment systems have fundamental limitations that limit
`their ultimate accuracy. The accuracy of preoperative planning is
`limited by the errors inherent to standard radiographs. With standard
`instrumentation,
`the
`correct
`location of
`crucial
`alignment
`landmarks . . . is limited during the performance of a TKR . . . .
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`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`[M]echanical alignment and sizing devices presume a standardized
`bone geometry that may not apply to a specific patient. Even the most
`elaborate mechanical
`instrumentation systems
`rely on visual
`inspection to confirm the accuracy of the limb and implant alignment.
`
`Stulberg, p. 25 (Ex.1005). Computer-based systems were designed to address
`
`these problems, and were designed with standard instruments and implants in
`
`mind. Id., pp. 25, 33 (Ex.1005). For example, the computer-assisted knee
`
`replacement technique discussed in 1999 in Stulberg “uses currently available
`
`mechanical total knee instruments” with computer-assisted techniques. Id., p. 33
`
`(Ex. 1005).
`
`
`
`Beyond alignment, computer-assisted surgery was used for customizing
`
`cutting blocks. The Radermacher Article, published in 1998, describes
`
`development of individual templates based on a patient’s CT-scan that are
`
`“customized on the basis of. . . the bone structures.” Radermacher Article, p. 29
`
`(Ex. 1006). This system “facilitates exact, safe, and fast implementation of
`
`planned surgery on bone structures, [and] eliminates the need for continual
`
`radiographic monitoring.” Id. (Ex. 1006).
`
`VI. SUMMARY OF THE ’896 PATENT AND RELEVANT FILE
`HISTORY
`
`The application that issued as the ’896 patent (Ex. 1001) was filed Nov. 25,
`
`2003, and was a continuation of U.S. patent application Ser. No. 10/191,751, filed
`
`
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`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`Jul. 8, 2002 and a continuation-in-part of Ser. Nos. 09/976,396, filed Oct. 11, 2001;
`
`09/941,185, filed Aug. 28, 2001; 09/566,070, filed May 5, 2000; 09/737,380, filed
`
`Dec. 15, 2000; 09/569,020, filed May 11, 2000; 09/483,676, filed Jan. 14, 2000;
`
`09/798,870, filed Mar. 1, 2001; 09/526,949, filed Mar. 16, 2000; and 09/789,621,
`
`filed Feb. 21, 2001. ’896 patent, cover page (Ex. 1001).
`
`A. The Challenged Claims of the ’896 Patent
`
`The challenged claims of the ’896 patent merely recite conventional
`
`techniques and instrumentation for performing knee surgery. Mabrey Decl. ¶ 42
`
`(Ex. 1002). Challenged claims 1 and 13 are reproduced below:
`
`1. A method of replacing at least a portion of a patient's knee,
`the method comprising the steps of:
`(a)3 making an incision in a knee portion of a leg of the patient;
`(b) determining a position of a cutting guide using references
`derived independently from an intramedullary device;
`(c) positioning a cutting guide using the determined position,
`passing the cutting guide through the incision and on a surface of a
`distal end portion of an unresected femur, the cutting guide secured to
`the bone free of an extramedullary or intramedullary alignment rod;
`(d) moving a cutting tool through the incision into engagement
`with a guide surface on the cutting guide; and
`
`
`3 Identifiers (a), (b), etc. have been added to facilitate discussion.
`
`
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`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`(e) forming at least an initial cut on the femur by moving the
`cutting tool along the guide surface;
`(f) attaching a replacement portion of the knee to the cut
`surface, the replacement portion having a transverse dimension that is
`larger than a transverse dimension of the guide surface.
`
`13. A method of replacing at least a portion of a joint in a
`patient, the method comprising the steps of:
`(a) obtaining a customized cutting guide fabricated for the
`patient based on preoperative
`information,
`the cutting guide
`positionable in a pre-determined position on a bone of the joint using
`references derived independently from an intramedullary device;
`(b) making an incision adjacent to the joint in the patient;
`(c) positioning the cutting guide in the pre-determined position
`by passing the cutting guide through the incision and on a surface of
`an end portion of an unresected bone of the joint;
`(d) moving a cutting tool through the incision into engagement
`with a guide surface on the positioned cutting guide;
`(e) cutting the unresected bone of the joint for the first time, by
`moving the cutting tool along the guide surface;
` (f) attaching a replacement portion of the knee to the cut
`surface, the replacement portion having a transverse dimension that is
`larger than a transverse dimension of the guide surface; and
`(g) disposing of the cutting guide, as it is no longer safely
`usable the bone for which it was custom fabricated having been cut
`and therefore changed.
`
`
`
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`

`’896 patent, claims 1 & 13 (Ex. 1001).
`
`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`
`As set forth in detail below, claims 1 and 13 do nothing more than describe
`
`and claim the conventional steps for performing a knee surgery using surgical
`
`techniques and instrumentation that was old and well-known as of the earliest
`
`possible priority date of the ’896 patent. See Mabrey Decl. ¶ 43 (Ex. 1002). That
`
`is, prior to August 28, 2001, surgeons knew of and had performed a knee
`
`replacement with reduced-size instrumentation and no intramedullary or
`
`extramedullary guidance (Claim 1) and with a custom cutting guide placed without
`
`intramedullary guidance (Claim 13). See id.
`
`B.
`
`Summary of Portion of the Specification Related to Challenged
`Claim
`
`The background of the specification acknowledges that many of the claimed
`
`steps were known. See ’896 patent, col. 1, l. 52 - col. 2, l. 38; col. 10, l. 25 - col.
`
`11, l. 2 (Ex. 1001). The specification states that during a known total or partial
`
`knee replacement “an incision is made in a knee portion of the leg to obtain access
`
`to the knee joint” (making an incision, recited in claim 1, limitation (a), and claim
`
`13, limitation (b)). Id., col. 1, ll. 52-55 (Ex. 1001). The specification further states
`
`that the incision is made “to enable instrumentation, such as a femoral alignment
`
`guide, femoral cutting guide, anterior resection guide, distal resection guide,
`
`posterior and chamfer resection guide to be positioned relative to a distal end
`
`
`
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`U.S. Patent 7,806,896
`Petition for Inter Partes Review
`
`portion of the femur” (passing instrumentation through an incision, recited in claim
`
`1, limitations (c) and (d), and claim 13, limitations (c) and (d)). Id., col. 1, ll. 55-
`
`59 (Ex. 1001). The specification also states that “[c]uts are made on a femur and
`
`tibia” (cutting the bone, recited in claim 1, limitation (e), and claim 13, limitation
`
`(e)) and “implants [are] positioned in the knee portion of the patient’s leg”
`
`(attaching a replacement portion of the knee, recited in claim 1, limitation (f), and
`
`claim 13, limitation (f)). Id., col. 2, ll. 28-29; col. 10, l. 62 (Ex. 1001).
`
`Of the 112 columns of material in the specification, only a few paragraphs
`
`even arguably relate to the purportedly novel features claimed. For example, the
`
`specification states: “A cut on a bone in the patient may be completed using
`
`previously cut surfaces as a guide for the cutting tool.” Id., col. 3, ll. 28-30 (Ex.
`
`1001). During prosecution, Applicant appears to have relied— without
`
`explanation— on this disclosure for the conclusion that: “the present invention
`
`provides a means for cutting bone, where the guide member is free of
`
`extramedullary or intramedullary members.” ’896 patent file history, April 30,
`
`2007, Response, p. 13 (Ex. 1014).4
`
`
`4 By contrast, the specifica