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`Mabrey Declaration
`U.S. Patent No. 7,806,896
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`DOCKET NO: 0286868-00188
`’896 PATENT
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
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`PATENT: 7,806,896
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`INVENTOR: PETER M. BONUTTI
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`FILED: NOV. 25, 2003
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` ISSUED: OCT. 5, 2010
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`TITLE: KNEE ARTHROPLASTY
`METHOD
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`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
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`DECLARATION OF JAY D. MABREY, MD, MBA REGARDING
`U.S. PATENT NO. 7,806,896
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`I, Jay D. Mabrey, declare as follows:
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`1. My name is Jay D. Mabrey.
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`2.
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`I received a B.A. in Biochemistry from Cornell University in 1977
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`and an M.D. from Weill Cornell Medical College in 1981. I also received an
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`M.B.A. from Texas Woman’s University in 2012.
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`3.
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`I served as an Intern in General Surgery in 1981, as a Resident in
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`General Surgery in 1982, as a Resident in Orthopaedics from 1983 to 1986, and as
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`S&N 1002
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`Mabrey Declaration
`U.S. Patent No. 7,806,896
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`Chief Resident in Orthopaedics in 1987, all at Duke University Medical Center in
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`Durham, North Carolina. I additionally completed a Fellowship in Biomechanics
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`and Total Joints at the Hospital for Special Surgery in New York, New York, in
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`1991.
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`4.
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`I received certifications from the National Board of Medical
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`Examiners in 1982 and from the American Board of Orthopaedic Surgery in 1989.
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`I was recertified by the American Board of Orthopaedic Surgery (Oral) in 1998
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`and by the American Board of Orthopaedic Surgery (Computer) in 2010. I have
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`held a permanent license to practice medicine in Texas since 1992.
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`5. My areas of expertise include orthopedic surgery, including knee and
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`hip replacement, medical device design, and computer assisted surgery. As
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`described in my curriculum vitae (CV), attached as Appendix A, I have extensive
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`experience related to performing knee replacement surgeries, as well as designing
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`medical devices for knee replacement surgery.
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`6.
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`I have held several academic appointments, including serving as the
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`Chief of the Department of Orthopaedics Baylor University Medical Center in
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`Dallas, Texas since 2004 and serving as a Professor of Surgery at Texas A&M
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`Health Science Center College of Medicine in Bryan, Texas since 2012. A
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`Mabrey Declaration
`U.S. Patent No. 7,806,896
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`complete list of my academic appointments is included in my CV, attached as
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`Appendix A.
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`7.
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`I have extensive industry experience consulting on the design of
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`medical devices, including work for Exactech on computer assisted navigation
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`systems, for DePuy on Surgical Robotics, and for Howmedica and Smith &
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`Nephew on Adult Reconstruction. I have also worked as a surgeon as part of my
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`service in the Army Reserve. A complete list of my civilian and military
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`experience is included in my CV, attached as Appendix A.
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`8.
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`I have authored or co-authored numerous peer-reviewed academic
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`publications in the field of orthopedic surgery, including Mabrey JD, Toohey JS,
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`Armstrong DA, Lavery L, Wammack LA: “Clinical pathway management of total
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`knee arthroplasty,” Clinical Orthopaedics and Related Research, Vol 345: pp 125-
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`133, December, 1997 and Covall DJ, Stulberg BN, Mabrey JD, Burstein AH,
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`Angibaud LD, Smith K, Zadzilka JD: “Introducing a New Technique for
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`Improving Predictability in Cruciate Retaining Total Knee Arthroplasty: The
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`Posterior Cruciate Referencing Technique.” Techniques in Knee Surgery.
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`8(4):271-275, December 2009. A complete list of my publications is included in
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`my CV, attached as Appendix A.
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`Mabrey Declaration
`U.S. Patent No. 7,806,896
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`9.
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`I am a named co-inventor on U.S. Patent Nos. 8,414,653 and
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`8,506,640, both related to a knee prosthesis system.
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`10.
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`I have served as a panelist on the FDA Orthopaedic Devices Panel
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`from 2004 to 2006 and then served as the Panel’s Chairman from 2006 through
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`2010.
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`11.
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`I have reviewed the specification and claims of U.S. Patent No.
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`7,806,896 (the “’896 patent” (Ex. 1001)). I have been informed that the ’896
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`patent was filed Nov. 25, 2003, and was a continuation of U.S. patent application
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`Ser. No. 10/191,751 filed Jul. 8, 2002 now U.S. Pat. No. 7,104,996 and a
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`continuation-in-part of the following applications: U.S. patent application Ser. No.
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`09/976,396 filed Oct. 11, 2001 now U.S. Pat. No. 6,770,078; U.S. patent
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`application Ser. No. 09/941,185 filed Aug. 28, 2001 now U.S. Pat. No. 6,702,821;
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`U.S. patent application Ser. No. 09/566,070, filed May 5, 2000, now U.S. Pat. No.
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`6,575,982; U.S. patent application Ser. No. 09/737,380 filed Dec. 15, 2000 now
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`U.S. Pat. No. 6,503,267; U.S. patent application Ser. No. 09/569,020 filed May 11,
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`2000 now U.S. Pat. No. 6,423,063; U.S. patent application Ser. No. 09/483,676
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`filed Jan. 14, 2000 now U.S. Pat. No. 6,468,289; U.S. patent application Ser. No.
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`09/798,870 filed Mar. 1, 2001 now U.S. Pat. No. 6,503,277; U.S. patent
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`application Ser. No. 09/526,949 filed on Mar. 16, 2000 now U.S. Pat. No.
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`Mabrey Declaration
`U.S. Patent No. 7,806,896
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`6,620,181; U.S. patent application Ser. No. 09/789,621 filed Feb. 21, 2001 now
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`U.S. Pat. No. 6,635,073. See ’896 patent, at cover page (Ex. 1001). I understand
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`that the earliest effective filing date of Claims 1 and 13 of the ’896 patent is
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`November 25, 2003. I further understand that even if Applicant asserts the
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`effective filing date is August 28, 2001, the filing date of U.S. Pat. No. 6,702,821,
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`challenged in a separate petition, the references are still prior art.
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`12.
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`I have also reviewed the following references:
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`•
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`Scott L. Delp, et al., “Computer Assisted Knee Replacement,”
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`Clinical Orthopaedics and Related Research, No. 354, pp. 49-56
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`(1998) (“Delp Article” (Ex. 1003)), which has a publication date of
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`1998, and is prior art to the ’896 patent under 35 U.S.C. § 102(b).
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`•
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`U.S. Patent No. 5,871,018 (“Delp ’018” (Ex. 1004)), which has a
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`filing date of June 6, 1997, and an issue date of February 16, 1999,
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`and is prior art to the ’896 patent under 35 U.S.C. § 102(b).
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`•
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`S. David Stulberg, et al., “Computer-Assisted Total Knee
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`Replacement Arthroplasty,” 10(1) Operative Techniques in
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`Orthopaedics, pp. 25-39 (Jan. 2000) (“Stulberg” (Ex. 1005)), which
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`has a publication date of Jan. 2000, and is prior art to the ’896 patent
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`under 35 U.S.C. § 102(b).
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`U.S. Patent No. 7,806,896
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`•
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`International Patent Application Publication No. WO 93/25157
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`(“Radermacher ’157” (Ex. 1007)), which has an international filing
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`date of June 17, 1993, and an international publication date of
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`December 23, 1993, and is prior art to the ’896 patent under 35 U.S.C.
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`§ 102(b).
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`•
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`Klaus Radermacher, et al., “Computer Assisted Orthopaedic Surgery
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`With Image Based Individual Templates,” 354 Clinical Orthopaedics
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`and Related Research, pp. 28-38 (1998) (“Radermacher Article” (Ex.
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`1006)), which has a publication date of 1998, and is prior art to the
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`’896 patent under 35 U.S.C. § 102(b).
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`•
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`Roderick H. Turner, Richard Matzan, and Yousif I. Hamati,
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`“Geometric and Anametric Total Knee Replacement,” in Total Knee
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`Replacement (A.A. Savastano, M.D. ed. 1980) (“Turner” (Ex. 1008)),
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`which has a publication date of 1980, and is prior art to the ’896
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`patent under 35 U.S.C. § 102(b).
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`•
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`Striker Howmedica Osteonics, “Scorpio Single Axis Total Knee
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`System: Passport A.R. Surgical Technique” (“Scorpio” (Ex. 1009)),
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`which has a publication date of May 2000, and is prior art to the ’896
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`patent under 35 U.S.C. § 102(b).
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`Mabrey Declaration
`U.S. Patent No. 7,806,896
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`13.
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`I am being compensated at my normal consulting rate for my work.
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`My compensation is not dependent on and in no way affects the substance of my
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`statements in this Declaration.
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`14.
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`I have no financial interest in Petitioner. I similarly have no financial
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`interest in the ’896 patent, and have had no contact with the named inventor of the
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`’896 patent.
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`Claim Construction
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`15.
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`I have been informed and understand that the terms of the claim must
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`be given their broadest reasonable interpretation. Based on that information and
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`understanding, I agree with and have applied the following broadest reasonable
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`interpretation of the claim term below to my analysis contained in this declaration:
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`16. The term “cutting guide” should mean a “guide that has a guide
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`surface” and that the term “guide surface” should mean “a surface that guides a
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`cutting instrument.” This definition is consistent with the ’896 patent’s
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`specification. See, e.g., ’896 patent, col. 38, ll. 9-18 (Ex. 1001).1
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`1 I understand that this claim construction is appropriate under the “broadest
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`reasonable construction” standard applied at the U.S.P.T.O. and does not indicate
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`what claim construction would be appropriate in a District Court proceeding.
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`Mabrey Declaration
`U.S. Patent No. 7,806,896
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`17. The term “customized cutting guide” should mean “a cutting guide
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`modified for a specific patient.” This definition is consistent with the ’896 patent’s
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`specification. See ’896 patent, col. 108, ll. 19-21 (Ex. 1001).
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`Background of the Technology
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`18. The challenged claims of the ’896 patent relate to methods for knee
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`replacement surgery, also known as knee arthroplasty.
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`19. Generally, there are two types of knee replacement surgeries: total
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`knee and partial knee replacement. During either type of knee replacement, an
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`orthopedic surgeon replaces either a portion of or all of a damaged knee with an
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`artificial device (also known as a prosthesis or an implant). Although a total knee
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`arthroplasty (“TKA”) is the most common procedure, some people can benefit
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`from replacing only a portion of the knee, such as the medial femoral-tibial joint.
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`This partial replacement is sometimes called a unicondylar knee arthroplasty
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`(“UKA”).
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`20. Knee replacement was not new when the ’896 patent was filed. Some
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`elementary background in the anatomical terms of location, the knee anatomy, and
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`the surgical procedure is helpful to understand fully the claim limitations in the
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`challenged claim and to appreciate how the prior art renders the claim unpatentable.
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`Anatomical Terms of Location
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`U.S. Patent No. 7,806,896
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`21. The following standard anatomical terms are relevant to knee
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`replacement:
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`• Anterior – Front of the body
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`• Posterior – Rear of the body
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`• Medial – Toward the center of the body
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`• Lateral – Left and right of the body
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`• Proximal – End of an appendage closer to torso
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`• Distal – End of an appendage further from torso
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`Relevant Knee Anatomy
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`22. At a simple conceptual level, the knee works like a modified hinge on
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`a door. Bending of the knee is called “flexion” and straightening of the knee is
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`called “extension.” The knee is more complex than a simple hinge and actually
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`rotates around its central axis as it flexes and extends.
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`23. The knee is a major weight-bearing joint that is held together by
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`muscles, ligaments, and soft tissue. Cartilage inside the joint provides shock
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`absorption, which is used to walk, run, lift, climb stairs, etc. The illustration below
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`shows the components of the knee:
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`Illustration of Components of Human Knee
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`24. A human knee is comprised of four main components: bones,
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`ligaments, cartilage, and tendons.
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`25. Bones - A knee is made up of the thighbone (femur), the shinbone
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`(tibia), the fibula, and the kneecap (patella). The thighbone and shinbone come
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`together to form a hinge. The kneecap rests in front of this hinge to provide
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`protection, but is not connected to the joint itself. Instead, the back of the kneecap
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`(called the articulating surface) sits in a groove in the thighbone that allows the
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`thighbone to rotate as the patella slides in this groove. When the knee bends or
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`Mabrey Declaration
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`straightens, the patella slides through that groove. This groove is sometimes called
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`the femoral groove, the patellar groove, or the trochlear groove. The end of the
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`thigh bone has two rounded areas called condyles, which glide against the cartilage
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`of the shin bone. Two major supporting ligaments of the knee are the medial and
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`lateral collateral ligaments. They attach to the medial and lateral femoral
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`epicondyles. The epicondyles serve as reference points for positioning total knee
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`implants during surgery. The features are shown below:
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`Illustration of Bent Knee with Patella Cut Away from Thighbone
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`26. Ligaments - Ligaments hold the components of the knee together and
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`keep them stable.
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`27. Cartilage – Cartilage act as shock absorbers and low friction surfaces
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`so that the bones can easily rotate.
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`28. Tendons - Tendons connect muscle to the knee bones.
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`Knee Replacement Surgery
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`Mabrey Declaration
`U.S. Patent No. 7,806,896
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`29. When a knee has been damaged by a disease like osteoarthritis, knee
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`replacement surgery can replace the damaged portions with artificial components.
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`Before the surgeon can begin the procedure, however, the parts of the knee to be
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`replaced must be exposed. A surgeon will expose the operative areas by first
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`making an incision through the patient’s skin. The surgeon will then typically
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`access the operative area by moving the patella out of the trochlear groove to
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`expose the condyles and the intercondyle notch. The surgeon offsets the patella to
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`the side of the knee by either pushing it over (displacing it laterally) without
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`flipping it over, or by lifting the patella off of the knee and rotating it to the side
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`such that the articulating surface is no longer facing the femur (referred to as
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`everting). Once the surgeon offsets the patella, unless she is resurfacing the patella
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`(described below), the surgeon will maintain the patella in the offset position, so
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`that she has access to the bones of the knee during the surgery.
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`30. Once the knee is exposed, the surgeon will conduct the replacement
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`through four phases: preparing the bone; positioning the implant; resurfacing the
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`patella; and inserting a spacer.
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`31. Preparing the Bone – The surgeon removes the damaged cartilage
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`surfaces at the ends of the femur and tibia and a small amount of underlying bone.
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`Mabrey Declaration
`U.S. Patent No. 7,806,896
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`The figures below show an example of the cuts a surgeon would typically make to
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`a femur during surgery and the results of those cuts.
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`Illustrations of Knee Resection Cuts (Fig. 16) and Resected Knee (Fig. 17)
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`U.S. Patent No. 4,502,483, filed March 9, 1983 (“Lacey ’483”), Figs. 16 & 17 (Ex.
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`1013)).
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`32. To help ensure that cuts are made accurately, surgeons typically use
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`cutting guides with a guide surface that guides the saw used to cut (or “resect”) the
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`bone. Cutting guides, also known as resection guides or guide members, come in
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`many different shapes and sizes. A few illustrative examples of prior art cutting
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`guides are shown below:
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`Mabrey Declaration
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`Illustrative Examples of Prior Art Cutting Guides
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`Smith & Nephew Genesis Uni, p. 16; Figs. 29 (Ex. 1018) (top left); Lackey ’803,
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`Fig. 11 (Ex. 1019) (assigned to Smith & Nephew Richards) (top center); Richards,
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`p. 3 (Ex. 1020) (top right); Turner, Fig. 8; p. 181 (Ex. 1008) (bottom left);
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`Radermacher ’157, Fig. 13a (Ex. 1007) (bottom center); Keblish, Fig. 10 (Ex. 1021)
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`(bottom right).
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`33. As shown above, in some cutting guides, such as the Smith & Nephew
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`Genesis Uni, the guide surface is a slot. In other cutting guides, such as the Turner
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`example, the cutting surface is provided without a slot. Other cutting guides, such
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`as the Radermacher example, contain open guide surfaces (e.g., 20b) and a slot
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`(e.g., 20c). Whether a slot is used is a matter of surgeon preference. Some
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`surgeons prefer cutting guides with slots, which provide greater guidance of the
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`saw blade, whereas other surgeons prefer open cutting surfaces, which are easier to
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`clean, generate less metallic debris, and make it easier for the surgeon to adjust the
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`cut. The design choice between slots and open cutting guides was within the level
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`of ordinary skill to design and modify when the ’896 patent was filed. The
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`placement and extent of the cutting surface is also within the level of ordinary skill.
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`Each had known attributes and predictable results.
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`34.
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`Initially, surgeons positioned cutting guides by hand. Beginning in
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`the 1960’s and 1970’s, surgeons started using mechanical alignment guides to
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`assure that cutting guides were properly aligned with the leg when placed on the
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`bone. Two common types of alignment guides are intramedullary alignment rods,
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`which are inserted into the medullary canal (bone marrow cavity) of the bone and
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`extramedullary alignment rods, which are placed externally along the medullary
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`canal of the bone.
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`Illustrations of an Intramedullary Alignment Device (Left) and an
`Extramedullary Alignment System (Right)
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`Stulberg, p. 32, Figs. 10-11 (Ex.1005).
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`35. More recently, during the 1990’s, surgeons began using computer
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`assisted techniques to guide the placement of cutting blocks and create customized
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`cutting guides adapted to fit a specific patient’s bone.
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`36. Positioning the Metal Implants – The surgeon replaces the removed
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`cartilage and bone with metal components that recreate the surface of the joint.
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`Before implanting a metal implant, the surgeon will typically test the fit of the
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`implant with a trial prosthesis that is the same size as the metal implant, but is not
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`implanted. After confirming the fit with the trial prostheses, the metal implants
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`may be cemented or “press-fit” into the bone.
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`37. Resurfacing the Patella – In some circumstances, the surgeon cuts and
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`resurfaces the undersurface of the patella (kneecap) with a plastic button.
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`38.
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`Inserting a Spacer – The surgeon inserts a medical-grade plastic
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`spacer between the metal components to create a smooth gliding surface.
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`39. Once the surgeon has completed these four phases of the knee
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`replacement surgery, she will place the various components of the now-updated
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`knee into their original positions. This includes moving the patella back into the
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`replaced trochlear groove. She will then perform various tests to assure that the
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`knee has the proper functionality and mobility, and close the incision.
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`Computer Assisted Knee Surgery
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`40. Computer-assisted knee replacement was not new when the ’896
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`patent was filed.2 One approach developed in the 1990’s uses preoperative
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`scanning techniques (e.g., MRI, CT-scan, etc.) to visualize an individual patient’s
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`bony knee anatomy. Other systems utilize bony landmarks and centers of rotation
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`acquired at the time of surgery to establish proper axes of alignment. These
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`techniques permit the surgeon to identify important landmarks that ensure that the
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`implants are properly installed. In addition, those techniques that utilize scans can
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`be used to create customized cutting blocks that interface precisely with the
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`patient’s bony anatomy and ensure accurate placement of the implants. These
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`were developed due to the failings of standard mechanical techniques:
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`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 . . . .
`[M]echanical alignment and sizing devices presume a standardized
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`2 The ’896 patent acknowledges image guided surgery systems were “known” and
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`“commercially available.” E.g., ’896 patent, col. 42, ll. 30-39 (Ex. 1001).
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`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.
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`Stulberg, p. 25 (Ex.1005). Computer-based systems were designed to address
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`these problems, Stulberg, p. 25 (Ex.1005), and were designed with standard
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`instruments and implants in mind. Stulberg, p. 33 (Ex.1005). For example, the
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`computer-assisted knee replacement technique discussed in 1999 in Stulberg “uses
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`currently available mechanical total knee instruments” with the disclosed
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`computer-assisted alignment techniques. Id., p. 33 (Ex. 1005).
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`41. Beyond alignment, computer-assisted surgery was used for
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`customizing cutting blocks. The Radermacher Article, published in 1998,
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`describes development of individual templates based on a patient’s CT-scan that
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`are “customized on the basis of. . . the bone structures.” Radermacher Article, p.
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`29 (Ex. 1006). This system “facilitates exact, safe, and fast implementation of
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`planned surgery on bone structures, [and] eliminates the need for continual
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`radiographic monitoring.” Id.(Ex. 1006).
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`The ’896 Patent
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`Mabrey Declaration
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`42. The challenged claims of the ’896 patent merely recite conventional
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`techniques and instrumentation for performing knee surgery. Challenged claims 1
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`and 13 are reproduced below:
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`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
`(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.
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`3 The identifiers (a), (b), etc. have been added to the limitations to facilitate
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`discussion of the claims.
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`Mabrey Declaration
`U.S. Patent No. 7,806,896
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`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 and 13, Ex. 1001.
`
`43. 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
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`surgical techniques and instrumentation that was old and well-known as of the
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`Mabrey Declaration
`U.S. Patent No. 7,806,896
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`earliest possible priority date of the ’896 patent. See That is, prior to August 28,
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`2001, surgeons knew of and had performed a knee replacement with reduced-size
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`instrumentation and no intramedullary or extramedullary guidance (Claim 1) and
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`with a custom cutting guide placed without intramedullary guidance (Claim 13).
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`44. The background of the specification acknowledges that many of the
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`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)). ’896 patent, 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
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`relative to a distal end portion of the femur” (passing instrumentation through an
`
`incision, recited in claim 1, limitations (c) and (d), and claim 13, limitations (c) and
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`(d)). ’896 patent, 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,
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`Mabrey Declaration
`U.S. Patent No. 7,806,896
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`recited in claim 1, limitation (f), and claim 13, limitation (f)). ’896 patent, col. 2, ll.
`
`28-29; col. 10, l. 62 (Ex. 1001).
`
`45. Of the 112 columns of material in the specification, only a few
`
`description paragraphs even arguably relate to the purportedly novel features of the
`
`claimed invention. 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.” ’896 patent, 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
`
`46. The specification also describes “computer navigation systems”:
`
`It is contemplated that emitters, receivers, and/or reflectors of
`computer navigation systems could be pinned or otherwise attached
`onto the femur 126 and tibia 214 to provide cutting positions and to
`
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`4 By contrast, the specification provides extensive description of “exemplary
`
`embodiment[s]” of the invention that disclose the opposite, namely, the use of
`
`intramedullary and extramedullary alignment devices. E.g., ’896 patent, col. 17, ll.
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`15-19; col. 103, ll. 37-39; Fig. 16 (showing “intramedullary rod 132”) (Ex. 1001).
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`Mabrey Declaration
`U.S. Patent No. 7,806,896
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`facilitate ligament balancing through relatively small incisions. The
`computer navigation system may utilize three or four separate
`registers which have optical feedback to a central unit [and] may
`utilize electromagnetic or photo-optical feedback.
`
`’896 patent, col. 36, ll. 55-58 (Ex. 1001). The specification acknowledges that
`
`image-guided surgery systems were “known” and “commercially available.” ’896
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`patent, col. 42, ll. 30-39 (Ex. 1001).
`
`47. The specification additionally describes “downsized instrumentation”:
`
`
`
`[T]he femoral alignment guide 134 and anterior resection guide
`138 have transverse dimensions, perpendicular to a longitudinal
`central axis of the femur 126, which are smaller than transverse
`dimensions of a femoral implant 290, tibial bearing insert 294, and a
`tibial tray 286 (FIG. 29) in a direction perpendicular to the
`longitudinal central axis of the femur 126 (FIG. 9).
`
`’896 patent, Figs. 9, 29; col. 17, ll. 53-59 (Ex. 1001). The specification
`
`acknowledges that the instrumentation in Figure 9 (as well as in Figures 10 through
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`Mabrey Declaration
`U.S. Patent No. 7,806,896
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`21), “with the exception of being down sized, is generally similar to known
`
`instrumentation which is commercially available . . . under the trademark ‘Scorpio’
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`single access total knee system.” ’896 patent, col. 36, ll. 61-65 (Ex. 1001).
`
`48. The specification also notes that “customized instrumentation” is
`
`possible and discusses benefits associated with disposable instrumentation. ’896
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`patent, col. 108, ll. 19-26 (Ex. 1001).
`
`The Prior Art That Renders The Challenged Claim Unpatentable
`
`49. The challenged claims recite features long known by persons of skill
`
`in the art in the field of knee arthroplasty. The purported invention is a
`
`combination of known features, each of which was well known to those skilled in
`
`the art before and at the time to which the ’896 patent claims priority. As
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`discussed in the grounds presented below, the claimed methods were known, the
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`claimed steps performed in expected ways, and any benefit that the steps achieve
`
`was expected. Based on the prior art cited herein, the claimed limitations of the
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`alleged invention perform known functions with an expected result, and are
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`therefore unpatentable.
`
`Delp Article
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`50. The Delp Article describes computer-assisted surgical systems
`
`developed to overcome problems with mechanical alignment systems. Delp
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`U.S. Patent No. 7,806,896
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`Article, pp. 49-56 (Ex. 1003). Computer-assisted systems can use “computer
`
`integrated instruments” that augment “mechanical instruments through the addition
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`of measurement probes that can be used to locate joint centers, track surgical tools,
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`and align prosthetic components.” Id., p. 50 (Ex. 1003). The Delp Article explains
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`that “[c]omputer integrated instruments that combine standard cutting guides with
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`highly accurate measurement equipment are a natural extension of current
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`techniques and offer several potential advantages.” Delp Article, p. 55 (Ex. 1003).
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`In particular, the Delp Article explains that a computer-integrated instrument
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`system “eliminates the need for intramedullary and extramedullary alignment
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`guides.” Delp Article, p. 55 (Ex. 1003). Computer-assisted systems can also use
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`“image guided knee replacement,” where a three-dimensional preoperative plan
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`guides component placement. Delp Article, p. 50 (Ex. 1003). A person of
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`ordinary skill in the art would understand from reading the Delp Article that a
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`computer-assisted surgical system can use both computer-integrated instruments
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`and image-guided knee replacement.
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`Delp ’018
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`51. Delp ’018 “relates generally to computer-assisted surgical systems,
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`and in particular to a computer-assisted knee replacement system used to achieve
`
`accurate limb alignment with minimal surgical invasiveness.” Delp ’018, col. 1, ll.
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`Mabrey Declaration
`U.S. Patent No. 7,806,896
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`8-11 (Ex. 1004). Delp ’018 aims “to provide a method of performing knee
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`arthroplasty that does not require the use of an intramedullary rod in the femur.”
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`Delp ’018, col. 5, ll. 49-51 (Ex. 1004). It explains that the “invention overcomes
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`alignment problems by determining optimal alignment preoperatively and using
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`computer guidance to help the surgeon achieve this alignment.” Delp ’018, col. 22,
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`ll. 42-44 (Ex. 1004). Delp ’018 further explains that the “computer replaces large,
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`complicated mechanic
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