DOCKET NO: 0286868.00189
`
`
`IPR2013-00620
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`PATENT: 6,702,821
`
`INVENTORS: PETER M. BONUTTI
`
`
`
`
`
`FILED: AUGUST 28, 2001
` ISSUED: MARCH 9, 2004
`TITLE: INSTRUMENTATION FOR MINIMALLY INVASIVE JOINT
` REPLACEMENT AND METHODS FOR USING SAME
`
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`
`
`FEE AUTHORIZATION
`
`The undersigned authorizes the Office to charge $23,000 to Deposit Account
`
`No. 080219 for the fee set forth in 37 C.F.R. § 42.15(a) for this Petition for Inter
`
`Partes Review. The undersigned further authorizes payment for any additional
`
`fees that might be due in connection with this Petition to be charged to the above-
`
`referenced Deposit Account.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`__/Michael Smith/_____
`Michael H. Smith
`Registration No. 71,190
`
`S&N EXHIBIT 1025
`S&N v. BSI
`IPR2013-00629
`
`

`

`DOCKET NO.: 0286868-00189
`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. 6,702,821 to Peter M. Bonutti
`
`IPR Trial No. TBD
`
`
`
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 6,702,821
`UNDER 35 U.S.C. § 312 AND 37 C.F.R. § 42.104
`
`
`
`
`
`
`
`
`
`
`

`

`
`
`I.
`
`U.S. Patent 6,702,821
`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. LEGAL PRINCIPLES ..................................................................................... 4
`
`V.
`
`CLAIM CONSTRUCTION ............................................................................ 6
`
`VI. OVERVIEW OF KNEE ANATOMY AND KNEE REPLACEMENT ......... 8
`
`VII. SUMMARY OF THE ’821 PATENT AND RELEVANT FILE
`HISTORY ...................................................................................................... 17
`
`A.
`
`B.
`
`C.
`
`D.
`
`The Challenged Claim of the ’821 Patent ........................................... 17
`
`Summary of Portions of the Specification Related to
`Challenged Claim ................................................................................ 19
`
`The Effective Filing Date of the ’821 Issued Claims ......................... 22
`
`Summary of the Prosecution History of the ’821 Patent .................... 22
`
`VIII. THE PRIOR ART RENDERS THE CHALLENGED CLAIM
`UNPATENTABLE ........................................................................................ 23
`
`A.
`
`The References .................................................................................... 24
`i
`
`
`
`
`
`

`

`
`
`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`Turner ........................................................................................ 24
`
`Ranawat ..................................................................................... 25
`
`Scorpio ...................................................................................... 27
`
`Delp ’018................................................................................... 28
`
`Lackey ’803............................................................................... 29
`
`IX.
`
`IDENTIFICATION OF HOW THE CHALLENGED CLAIMS ARE
`UNPATENTABLE ........................................................................................ 30
`
`A.
`
`Independent Claim 1 ........................................................................... 30
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`Claim 1 is Anticipated by Turner ............................................. 30
`
`Claim 1 is Obvious Over Turner............................................... 36
`
`Claim 1 is Anticipated by Ranawat .......................................... 37
`
`Claim 1 is Obvious Over Ranawat ........................................... 42
`
`Claim 1 is Obvious Over Scorpio in View of Delp
`’018 ........................................................................................... 43
`
`Claim 1 is Obvious Over Lackey ’803 in View of
`Delp ’018................................................................................... 53
`
`X.
`
`CONCLUSION ............................................................................................. 60
`
`
`
`ii
`
`
`
`
`
`

`

`
`
`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`TABLE OF AUTHORITIES
`
`
`FEDERAL CASES
`Graham v. John Deere Co.,
`383 U.S. 1 (1966) .................................................................................................. 5
`
`Page(s)
`
`In re ICON Health & Fitness, Inc.,
`496 F.3d 1374 (Fed. Cir. 2007) ............................................................................ 6
`
`In re Schreiber,
`128 F.3d 1473 (Fed. Cir. 1997) ............................................................................ 4
`
`KSR International Co. v. Teleflex Inc.,
`550 U.S. 398 (2007) .......................................................................................... 5, 6
`
`Rockwell Int’l Corp. v. United States,
`147 F.3d 1358 (Fed. Cir. 1998) ............................................................................ 5
`
`STATUTES
`
`35 U.S.C. § 102 .......................................................................................................... 4
`
`35 U.S.C. § 102(b) ................................................................................................. 3, 4
`
`35 U.S.C. § 103 ...................................................................................................... 4, 5
`
`35 U.S.C. § 112 .......................................................................................................... 7
`
`35 U.S.C. § 314(a) ..................................................................................................... 4
`
`OTHER AUTHORITIES
`
`Rule 42.22(a)(1) ......................................................................................................... 2
`
`Rule 42.100(b) ........................................................................................................... 6
`
`Rule 42.104(a) ............................................................................................................ 2
`
`Rule 42.104(b)(1)-(2) ................................................................................................. 2
`
`
`
`
`
`iii
`
`

`

`
`Rule 42.104(b)(4)-(5) ............................................................................................... 30
`
`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`77 Fed. Reg. 48764 (Aug. 14, 2012) ......................................................................... 7
`
`
`
`
`
`iv
`
`

`

`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`I. MANDATORY NOTICES
`A. Real Party-in-Interest
`Smith & Nephew, Inc. (“Petitioner”) is the real party-in-interest and submits
`
`this inter partes review Petition (“Petition”) for review of a certain claim of U.S.
`
`Patent No. 6,702,821 (“’821 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 ’821
`
`patent, U.S. Patent No. 5,980,559, U.S. Patent No. 7,087,073, U.S. Patent
`
`7,749,229, U.S. Patent No. 7,806,896, and U.S. Patent No. 8,133,229. The ’821
`
`patent is the subject of this Petition. Separate petitions for inter partes review of
`
`the other patents above are being filed in addition to this Petition. 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
`
`

`

`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`Service Information
`
`D.
`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
`
`claim 1 of the ’821 patent (Ex. 1001).
`
`Prior Art Patents and Printed Publications
`A.
`Petitioner relies upon the following patents and printed publications:
`
`1. Roderick H. Turner, Richard Matzan, and Yousif I. Hamati, “Geometric and
`
`Anametric Total Knee Replacement,” in Total Knee Replacement (A.A.
`
`
`
`2
`
`

`

`Savastano, M.D. ed., 1980) (“Turner” (Ex. 1003)), which has a publication
`
`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`date of 1980, and is prior art to the ’821 patent under 35 U.S.C. § 102(b)1.
`
`2. Chitranjan S. Ranawat and Lawrence D. Dorr, “G. Technique of Total Knee
`
`Arthroplasty with Precision Cut Instruments,” in Total-Condylar Knee
`
`Arthroplasty: Technique, Results, and Complications (Chitranjan S. Ranawat
`
`ed., 1985) (“Ranawat” (Ex. 1004)), which has a publication date of 1985, and
`
`is prior art to the ’821 patent under 35 U.S.C. § 102(b).
`
`3. Stryker Howmedica Osteonics, “Scorpio Single Axis Total Knee System:
`
`Passport A.R. Surgical Technique” (“Scorpio” (Ex. 1005)), which has a
`
`publication date of May 2000, and is prior art to the ’821 patent under 35
`
`U.S.C. § 102(b).
`
`4. U.S. Patent No. 5,871,018 (“Delp ’018” (Ex. 1006)), which has a filing date of
`
`June 6, 1997, and an issue date of February 16, 1999, and is prior art to the
`
`’821 patent under 35 U.S.C. § 102(b).
`
`
`1 The ’821 patent was issued prior to the America Invents Act (“AIA”). Therefore,
`
`Petitioner has chosen to use the pre-AIA statutory framework to refer to the prior
`
`art.
`
`
`
`3
`
`

`

`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`5. U.S. Patent No. 5,282,803 (“Lackey ’803” (Ex. 1014)), which has a filing date
`
`of March 30, 1992, and an issue date of February 1, 1994, and is prior art to
`
`the ’821 patent under 35 U.S.C. § 102(b).
`
`B. Grounds for Challenge
`Petitioner requests cancellation of claim 1, the challenged claim, as
`
`unpatentable under 35 U.S.C. § 102 and 35 U.S.C. § 103.
`
`This Petition, supported by the declaration of Dr. 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).
`
`IV. LEGAL PRINCIPLES
`The challenged claim is anticipated and/or obvious under 35 U.S.C. §§ 102
`
`and 103, respectively. “To anticipate a claim, a prior art reference must disclose
`
`every limitation of the claimed invention, either explicitly or inherently.” See, e.g.,
`
`In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997).
`
`The challenged claim is also unpatentable because it is obvious under 35
`
`U.S.C. § 103. A claim is invalid if it would have been obvious—that is,
`
`if the differences between the subject matter sought to be patented and
`the prior art are such that the subject matter as a whole would have
`
`
`
`4
`
`

`

`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`been obvious at the time the invention was made to a person having
`ordinary skill in the art to which [the] subject matter pertains.
`
`35 U.S.C. § 103; see also Rockwell Int’l Corp. v. United States, 147 F.3d 1358,
`
`1364 (Fed. Cir. 1998).
`
`In KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415 (2007), the U.S.
`
`Supreme Court addressed the issue of obviousness and provided an “expansive and
`
`flexible approach” that is consistent with the “broad inquiry” set forth in Graham
`
`v. John Deere Co., 383 U.S. 1 (1966). According to the Supreme Court, a person
`
`of ordinary skill in the art is “a person of ordinary creativity, not an automaton,”
`
`KSR, 550 U.S. at 421, and “in many cases a person of ordinary skill will be able to
`
`fit the teachings of multiple patents together like pieces of a puzzle.” Id. at 420.
`
`The Court held that:
`
`[w]hen there is a design need or market pressure to solve a problem
`and there are a finite number of identified, predictable solutions, a
`person of ordinary skill has good reason to pursue the known options
`within his or her technical grasp. If this leads to the anticipated
`success, it is likely the product not of innovation but of ordinary skill
`and common sense. In that instance the fact that a combination was
`obvious to try might show that it was obvious under [35 U.S.C.]
`§ 103.
`
`Id. at 421. Thus, KSR focused on whether a combination of known elements could
`
`be patentable if it yielded predictable results. The Court’s guidance was clear: it
`
`
`
`5
`
`

`

`may not. “The combination of familiar elements according to known methods is
`
`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`likely to be obvious when it does no more than yield predictable results.” Id. at
`
`416. Further, “[i]f a person of ordinary skill can implement a predictable variation,
`
`§ 103 likely bars its patentability.” Id. at 417.
`
`The Board must ask, as guided by KSR, whether the challenged claim recites
`
`an improvement that is “more than the predictable use of prior art elements
`
`according to their established functions.” Id. The Board should conclude, based on
`
`the information in this Petition, that the challenged claim is merely a predictable
`
`combination of known elements that are used according to their established
`
`functions, that they are therefore unpatentable, and that an inter partes review of
`
`the challenged claims should therefore be instituted.
`
`V. CLAIM CONSTRUCTION
`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.
`
`
`2 The proposed claim construction herein applies the “broadest reasonable
`
`construction” standard and a construction under a different standard of claim
`
`interpretation (e.g., as applied in a District Court proceeding) may be different.
`
`
`
`6
`
`

`

`2007). The following discussion proposes constructions of and support therefore
`
`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`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 claim has a construction different from their broadest reasonable
`
`interpretation, the appropriate course is for the Patent Owner to seek to amend the
`
`claim 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 claim complies with 35 U.S.C. § 112.
`
`
`
`Claim 1 recites a “guide member” and a “guide surface.” These terms are
`
`not defined in the ’821 patent. The ’821 patent specification refers to an anterior
`
`resection guide (138), a distal resection guide (186), and the femoral cutting guide
`
`(210) as “guide members.” ’821 patent, col. 31, ll. 62-65; col. 33, ll. 25-34 (Ex.
`
`1001). The specification describes these “guide members” as having “guide
`
`surfaces” (e.g., ’821 patent, col. 31, ll. 43-48 (“anterior resection guide 138 . . . has
`
`a guide surface 178”); col. 34, ll. 3-10 (Ex. 1001)), and describes the “guide
`
`surfaces” as guiding cutting instruments. E.g., ’821 patent, col. 5, ll. 57-60 (Ex.
`
`1001). Therefore, the terms “guide member” and “guide surface” should be given
`
`their broadest reasonable interpretation and should be construed to mean a
`
`
`
`7
`
`

`

`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`“member that has a guide surface” and “a surface that guides a cutting instrument,”
`
`respectively.
`
`VI. OVERVIEW OF KNEE ANATOMY AND KNEE REPLACEMENT
`Challenged claim 1 of the ’821 patent relates to a method for knee
`
`replacement, also known as knee arthroplasty.
`
`Generally, there are two types of knee replacement surgeries: total knee and
`
`partial knee replacement. Mabrey Decl. ¶ 16 (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).
`
`Mabrey Decl. ¶ 16 (Ex. 1002). 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. Mabrey Decl. ¶ 16 (Ex. 1002).
`
`This partial replacement is sometimes called a unicondylar knee arthroplasty
`
`(“UKA”). Mabrey Decl. ¶ 16 (Ex. 1002).
`
`Knee replacement was not new when the patent was filed.3 Mabrey Decl. ¶
`
`17 (Ex. 1002). Some elementary background is helpful to understand fully the
`
`
`3 The background of the invention in the ’821 patent generally describes the
`
`method for a knee replacement. See ’821 patent, col. 1, ll. 25 – col. 2 ll. 32.
`
`
`
`8
`
`

`

`claim limitations in the challenged claim and to appreciate how the prior art
`
`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`renders the claim unpatentable. Mabrey Decl. ¶ 17 (Ex. 1002).
`
`A. Anatomical Terms of Location
`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. ¶ 18 (Ex. 1002).
`
`B. Relevant Knee Anatomy
`At a simple conceptual level, the knee works like a modified hinge on a
`
`door. Mabrey Decl. ¶ 19 (Ex. 1002). Bending of the knee is called “flexion” and
`
`straightening of the knee is called “extension.” Mabrey Decl. ¶ 19 (Ex. 1002).
`
`The knee is more complex than a simple hinge and actually rotates around its
`
`central axis as it flexes and extends. Mabrey Decl. ¶ 19 (Ex. 1002).
`
`The knee is a major weight-bearing joint that is held together by muscles,
`
`ligaments, and soft tissue. Mabrey Decl. ¶ 20 (Ex. 1002). Cartilage inside the
`
`joint provides shock absorption, which is used to walk, run, lift, climb stairs, etc.
`
`
`
`9
`
`

`

`and so on. Mabrey Decl. ¶ 20 (Ex. 1002). The illustration below shows the
`
`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`components of the knee:
`
`Illustration of Components of Human Knee
`
`
`
`Mabrey Decl. ¶ 20 (Ex. 1002).
`
`A human knee is comprised of four main components: bones, ligaments,
`
`cartilage, and tendons. Mabrey Decl. ¶ 21 (Ex. 1002).
`
`Bones - A knee is made up of the thighbone (femur), the shinbone (tibia), the
`
`fibula, and the kneecap (patella). Mabrey Decl. ¶ 22 (Ex. 1002). The thighbone
`
`and shinbone come together to form a hinge. Mabrey Decl. ¶ 22 (Ex. 1002). The
`
`kneecap rests in front of this hinge to provide protection, but is not connected to
`
`the joint itself. Mabrey Decl. ¶ 22 (Ex. 1002). Instead, the back of the kneecap
`
`(called the articulating surface) sits in a groove in the thighbone that allows the
`
`thighbone to rotate as the patella slides in this groove. Mabrey Decl. ¶ 22 (Ex.
`
`1002). When the knee bends or straightens, the patella slides through that groove.
`
`
`
`10
`
`

`

`Mabrey Decl. ¶ 22 (Ex. 1002). This groove is sometimes called the femoral
`
`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`groove, the patellar groove, or the trochlear groove. Mabrey Decl. ¶ 22 (Ex. 1002).
`
`The end of the thigh bone has two rounded areas called condyles, which glide
`
`against the cartilage of the shin bone. Mabrey Decl. ¶ 22 (Ex. 1002). Two major
`
`supporting ligaments of the knee are the medial and lateral collateral ligaments.
`
`Mabrey Decl. ¶ 22 (Ex. 1002). They attach to the medial and lateral femoral
`
`epicondyles. Mabrey Decl. ¶ 22 (Ex. 1002). The epicondyles serve as reference
`
`points for positioning total knee implants during surgery. Mabrey Decl. ¶ 22 (Ex.
`
`1002). The features are shown below in the figure:
`
`
`Illustration of Bent Knee with Patella Cut Away from Thighbone
`
`Mabrey Decl. ¶ 22 (Ex. 1002).
`
`Ligaments - Ligaments hold the components of the knee together and keep
`
`them stable. Mabrey Decl. ¶ 23 (Ex. 1002).
`
`
`
`11
`
`

`

`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`Cartilage – Cartilage act as shock absorbers and low friction surfaces so that
`
`the bones can easily rotate. Mabrey Decl. ¶ 24 (Ex. 1002).
`
`Tendons - Tendons connect muscle to the knee bones. Mabrey Decl. ¶ 25
`
`(Ex. 1002).
`
`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.
`
`Mabrey Decl. ¶ 26 (Ex. 1002). Before the surgeon can begin the procedure,
`
`however, the parts of the knee to be replaced must be exposed. Mabrey Decl. ¶ 26
`
`(Ex. 1002). A surgeon will expose the operative areas by first making an incision
`
`through the patient’s skin. Mabrey Decl. ¶ 26 (Ex. 1002). 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. Mabrey Decl. ¶ 26 (Ex.
`
`1002). 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). Mabrey Decl. ¶ 26 (Ex. 1002). Once the
`
`surgeon offsets the patella, unless she is resurfacing the patella (described below),
`
`the surgeon will maintain the patella in the offset position, so that she has access to
`
`the bones of the knee during the surgery. Mabrey Decl. ¶ 26 (Ex. 1002).
`
`
`
`12
`
`

`

`Once the knee is exposed, the surgeon will conduct the replacement through
`
`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`four phases: preparing the bone; positioning the implant; resurfacing the patella;
`
`and inserting a spacer. Mabrey Decl. ¶ 27 (Ex. 1002).
`
`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. Mabrey
`
`Decl. ¶ 28 (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.
`
`
`Illustrations of Knee Resection Cuts (Fig. 16) and Resected Knee (Fig. 17)
`
`
`
`U.S. Patent No. 4,502,483 Figs. 16 & 17 (filed March 9, 1983) (“Lacey ’483”) (Ex.
`
`1009); Mabrey Decl. ¶ 28 (Ex. 1002).
`
`To help ensure that cuts are made accurately, surgeons typically use cutting
`
`guides with guide surfaces that guide the saw used to cut (or “resect”) the bone.
`
`Mabrey Decl. ¶ 29 (Ex. 1002). Cutting guides, also known as resection guides or
`
`guide members, come in many different shapes and sizes. Mabrey Decl. ¶ 29 (Ex.
`
`1002). A few illustrative examples of prior art cutting guides are shown below:
`
`
`
`13
`
`

`

`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`
`
`
`
`Illustrative Examples of Prior Art Cutting Guides
`
`Smith & Nephew “Genesis Unicompartmental Knee System,” 1994 , p. 16; Figs.
`
`29-30 (Ex. 1012) (top left); Lackey ’803, Fig. 11 (Ex. 1014) (assigned to Smith &
`
`Nephew Richards) (top center); Richards, p. 3 (Ex. 1011) (top right); Turner, Fig.
`
`8; p. 181 (Ex. 1003) (bottom left); Radermacher ’157, Fig. 13a (Ex. 1013) (bottom
`
`center); Peter A. Keblish, Jr., M.D., “Surgical Techniques in the Performance of
`
`Unicompartmental Arthroplasties” (Ex. 1015), Operative Techniques in
`
`Orthopaedics, Vol. 8, No. 3 (July), 1998: pp. 134-145, Fig. 10 (bottom right).
`
`Mabrey Decl. ¶ 29 (Ex. 1002).
`
`
`
`As shown above, in some cutting guides, such as the Smith & Nephew
`
`Genesis Unicompartmental Knee System, the guide surface is a slot. Mabrey Decl.
`
`¶ 30 (Ex. 1002). In other cutting guides, such as the Turner example, the cutting
`
`surface is provided without a slot. Mabrey Decl. ¶ 30 (Ex. 1002). Other cutting
`
`
`
`14
`
`

`

`guides, such as the Radermacher example, contain open guide surfaces (e.g., 20b)
`
`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`and a slot (e.g., 20c). Whether a slot is used is a matter of surgeon preference.
`
`Mabrey Decl. ¶ 30 (Ex. 1002). 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. Mabrey Decl. ¶ 30 (Ex. 1002).
`
`Initially, surgeons positioned cutting guides by hand. Mabrey Decl. ¶ 31
`
`(Ex. 1002). Beginning in the 1960’s and 1970’s, surgeons started using
`
`mechanical alignment 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)
`
`
`
`15
`
`

`

`S. David Stulberg, et al., “Computer-Assisted Total Knee Replacement
`
`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`Arthroplasty” (“Stulberg”), p. 32, Figs. 10-11 (Ex.1010); Mabrey Decl. ¶ 31 (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. ¶ 32 (Ex. 1002).
`
`Positioning the Metal Implants – The surgeon replaces the removed cartilage
`
`and bone with metal components that recreate the surface of the joint. Mabrey
`
`Decl. ¶ 33 (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 not implanted. Mabrey Decl. ¶ 33 (Ex. 1002). After
`
`confirming the fit with the trial prosthesis, the metal implant may be cemented or
`
`“press-fit” into the bone. Mabrey Decl. ¶ 33 (Ex. 1002).
`
`Resurfacing the Patella – In some circumstances, the surgeon cuts and
`
`resurfaces the undersurface of the patella (kneecap) with a plastic button. Mabrey
`
`Decl. ¶ 34 (Ex. 1002).
`
`Inserting a Spacer – The surgeon inserts a medical-grade plastic spacer
`
`between the metal components to create a smooth gliding surface. Mabrey Decl. ¶
`
`35 (Ex. 1002).
`
`
`
`16
`
`

`

`Once the surgeon has completed these four phases of the knee replacement
`
`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`surgery, she will place the various components of the now-updated knee into their
`
`original positions. Mabrey Decl. ¶ 36 (Ex. 1002). This includes moving the
`
`patella back into the replaced trochlear groove. Mabrey Decl. ¶ 36 (Ex. 1002).
`
`She will then perform various tests to assure that the knee has the proper
`
`functionality and mobility, and close the incision. Mabrey Decl. ¶ 36 (Ex. 1002).
`
`The challenged claim of the ’821 patent relates to performing steps within
`
`the first two phases of knee replacement using a cutting guide that is smaller than
`
`the knee and the knee implant. Mabrey Decl. ¶ 37 (Ex. 1002).
`
`VII. SUMMARY OF THE ’821 PATENT AND RELEVANT FILE
`HISTORY
`
`The application that issued as the ’821 patent was filed on August 28, 2001,
`
`and was a continuation-in-part of U.S. Patent Application Ser. Nos. 09/737,380,
`
`filed Dec. 15, 2000; 09/815,405, filed Mar. 22, 2001; 09/569,020, filed May 11,
`
`2000; 09/483,676, filed Jan. 14, 2000; 09/602,743, filed Jun. 23, 2000; 09/526,949,
`
`filed on Mar. 16, 2000; and 09/789,621, filed Feb. 21, 2001. ’821 patent, cover
`
`(Ex. 1001).
`
`A. The Challenged Claim of the ’821 Patent
`The challenged claim of the ’821 patent recites a method of performing
`
`surgery on a patient’s knee using a guide that is narrower than the knee and a knee
`
`
`
`17
`
`

`

`implant that is wider than the guide. Mabrey Decl. ¶ 38 (Ex. 1002). The
`
`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`challenged claim is reproduced below:
`
`1. A method of performing surgery on a patient’s knee, said method
`comprising the steps of
`(a)4 supporting the patient on a support surface,
`(b) making an incision in a knee portion of one leg of the
`patient,
`(c) moving a guide member having opposite ends which are
`spaced apart by a distance which is less than two thirds (⅔) of a
`distance between tips of lateral and medial epicondyles on a femur in
`an upper portion of the one leg of the patient into the incision,
`(d) positioning the guide member on the femur in the one leg of
`the patient with opposite ends of the guide member substantially
`aligned with an axis through the lateral and medial epicondyles on the
`femur in the one leg of the patient,
`(e) moving a cutting tool through the incision into engagement
`with a guide surface on the guide member,
`(f) cutting the femur in the one leg of the patient with the
`cutting tool, said step of cutting the femur includes moving the cutting
`tool along the guide surface on the guide member, and
`
`
`4 The identifiers (a), (b), etc. and paragraph formatting have been added to the
`
`limitations to facilitate discussion of the claim.
`
`
`
`18
`
`

`

`U.S. Patent 6,702,821
`Petition for Inter Partes Review
`
`
`(g) positioning an implant in engagement with the femur in the
`one leg of the patient, wherein the implant has a transverse length that
`is larger than the guide surface length.
`
`’821 patent, claim 1 (Ex. 1001).
`
`The ’821 patent does nothing more than describe and claim the conventional
`
`steps for performing a knee surgery using surgical instrumentation that were old
`
`and well-known as of the earliest possible priority date of the ’821 patent. See
`
`Mabrey Decl. ¶ 39 (Ex. 1002). That is, more than a decade before 2001, when the
`
`patent application was filed, a surge