UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`MEDTRONIC, INC.
`Petitioner
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`v.
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`NUVASIVE, INC.
`Patent Owner
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`Case IPR2013-00506
`Patent 8,361,156
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`NUVASVE INC.’S
`PATENT OWNER RESPONSE
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`Patent No. 8,361,156
`Patent Owner Response
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`TABLE OF CONTENTS
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
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`I. 
`II. 
`III. 
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`IV. 
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`V. 
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`VI. 
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`INTRODUCTION ......................................................................................................... 1 
`BOARD’S DECISION TO INSTITUTE REVIEW ......................................................... 2 
`BACKGROUND ........................................................................................................... 4 
`A. 
`Background of modern implant design ............................................................ 4 
`B. 
`Background of implant sizing ........................................................................... 6 
`C. 
`Background of radiopaque implant markers .................................................. 12 
`D. 
`Background of the ‘156 patent ....................................................................... 14 
`SUMMARY OF THE PRIOR ART ............................................................................. 17 
`A. 
`Telamon (Ex. 1107 and 1108) ....................................................................... 17 
`B. 
`SVS-PR (Ex. 1106) ........................................................................................ 21 
`C. 
`Baccelli (Ex. 1104) ......................................................................................... 25 
`D. 
`Michelson (Ex. 1105) ..................................................................................... 27 
`E. 
`Saber (Ex. 1101, Appendix A) ....................................................................... 31 
`CLAIM 1 IS NOT RENDERED OBVIOUS BY THE PRIOR ART .............................. 32 
`A. 
`None of the prior art references discloses a posterior implant with a pair of
`radiopaque markers in the medial plane. ....................................................... 33 
`The cited references provide no motivation or reasoning to add a pair of
`radiopaque markers in the medial plane of posterior implants ...................... 36 
`It is not obvious to modify SVS-PR or Telamon to include a pair of radiopaque
`markers in the medial plane. .......................................................................... 37 
`CLAIM 5 IS NOT RENDERED OBVIOUS BY THE PRIOR ART .............................. 47 
`A. 
`SVS-PR and Telamon Are PLIF Implants Intended for PLIF Usage ............. 47 
`B. 
`Modifying the Posterior Implants in SVS-PR and Telamon to Exceed 40 mm
`Would Render Them Inoperable For Their Intended Purpose ....................... 49 
`i
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`C. 
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`B. 
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`Patent No. 8,361,156
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`Case IPR2013-00506
`Patent Owner Response
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`Attorney Docket No: 13958-0116IP2
`VII.  CLAIM 9 IS NOT RENDERED OBVIOUS BY THE PRIOR ART .............................. 57 
`A. 
`SVS-PR and Telamon Are PLIF Implants Intended for PLIF Usage ............. 57 
`B. 
`Modifying the Posterior Implants in SVS-PR and Telamon to be 18 mm in
`Width Would Render Them Inoperable For Their Intended Purpose ............ 57 
`VIII.  CONCLUSION .......................................................................................................... 59 
`CERTIFICATE OF SERVICE ........................................................................................
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`Patent No. 8,361,156
`Patent Owner Response
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`Case Law
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`TABLE OF AUTHORITIES
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
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`KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418-19 (2007) ............................... 17, 36, 39, 44
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`In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) ................................................................... 36
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`W.L. Gore & Associates, Inc. v. Garlock, Inc., 721 F.2d 1540, 1553 (Fed. Cir. 1983) ... 38, 56
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`In re Gordon, 733 F.2d 900, 902 (Fed. Cir. 1984) ................................................... 49, 55, 58
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`DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1326-29 (Fed. Cir.
`2009) .................................................................................................................. 49, 58
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`In re Ratti, 270 F.2d 810, 813 (CCPA 1959) ................................................................. 55, 56
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`Decisions of the Patent Trial and Appeal Board
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`Plas-Pak Industries, Inc. v. Sulzer Mixpac AG, 2014 WL 203101 ........................................ 50
`(Patent Tr. & App. Bd.)
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`Ex Parte Shufflebotham, et al., 2013 WL 5409872 (Patent Tr. & App. Bd.) ......................... 50
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`Ex Parte Landschaft, et al., 2013 WL 603815 (Patent Tr. & App. Bd.) ................................ 50
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`Ex Parte Atsuumi, et al., 2013 WL 1331590 (Patent Tr. & App. Bd.) ................................... 50
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`Statutes
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`35 U.S.C. § 103 .................................................................................................................. 2, 3
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`Rules and Regulations
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`37 CFR § 42.107(c) ............................................................................................................... 2
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`37 C.F.R. § 42.22(a)(2) ......................................................................................................... 44
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`Patent No. 8,361,156
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`EXHIBITS
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
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`Exhibit Description
`Ex. #
`NUVA 2101 U.S. Patent No. 7,905,840 to Pimenta et al.
`NUVA 2102 Declaration in Support of the Pro Hac Vice Admission of Michael A. Amon;
`Declaration of Charles Forthaus (Not Filed)
`NUVA 2103 Vetebral Spacer-PR Brochure (Not Filed)
`NUVA 2104
`Forthaus Memo regarding Vertebral Spacer-PR Brochure (Not Filed)
`NUVA 2105 myspinetools.com front page (Not Filed)
`NUVA 2106 myspinetools.com Terms of Use (Not Filed)
`NUVA 2107
`Launch Binder (Not Filed)
`NUVA 2108 Webpage Toad MySQL (Not Filed)
`NUVA 2109 Reserved
`NUVA 2010 U.S. Patent 8,512,408 (Hynes) (Not Filed)
`NUVA 2011 Synthes SVS-PR Guide
`NUVA 2012 Medtronic Sofamor Danek Boomerang brochure
`NUVA 2013 Hynes Deposition Transcript
`NUVA 2014
`510(k) Summary Medtronic Sofamor Danek K122037
`NUVA 2015
`510(k) Summary Telamon® PEEK Spinal System K110562
`NUVA 2016 Synthes Vertebral Spacer – AR Brochure
`NUVA 2017 DePuy Spine Saber Surgical Technique Brochure
`NUVA 2018 Declaration of Barton L. Sachs, M.D. in IPR2013-00206
`NUVA 2019 Moro, et al., “An Anatomic Study of the Lumbar Plexus with Respect to
`Retroperitoneal Endoscopic Surgery”
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`NUVA 2020 Declaration of Dr. Hansen A. Yuan, M.D.
`NUVA 2021 Curriculum Vitae of Dr. Hansen A. Yuan, M.D.
`NUVA 2022 NuVasive - CoRoent XL Brochure
`NUVA 2023 Redacted Engineering Drawings
`NUVA 2024 Redacted Deposition of Steven DeRidder
`NUVA 2025 Clydesdale® Spinal System Brochure
`NUVA 2026 Clydesdale® Spinal System Images
`NUVA 2027 Medtronic Direct Lateral Interbody Fusion DLIF Surgical Technique
`Brochure
`NUVA 2028 Medtronic DILF-Direct Lateral Interbody Fusion Brochure
`NUVA 2029 Clydesdale® Spinal System Image
`NUVA 2030 Declaration of Patrick Miles
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`Patent No. 8,361,156
`Patent Owner Response
`I.
`INTRODUCTION
`Medtronic, Inc. (“Medtronic”) seeks inter partes review of U.S. 8,361,156 (“the ‘156
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`Case IPR2013-00506
`Attorney Docket No: 13958-0116IP2
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`patent”), which was asserted against Medtronic in a counterclaim of a lawsuit initiated by
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`Medtronic. The claims of the ‘156 patent are tailored to a unique combination of features
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`collectively provided in a spinal implant—features particularly suited for implant insertion in
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`a lateral, trans-psoas surgical approach path. Yuan Decl. (Ex. 2020), ¶ 47; Ex. 1115, 5:29-
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`31. The implant depicted in the ‘156 patent was the first lateral, trans-psoas fusion implant
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`that achieved commercial success, and it pioneered a surgical method that changed the
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`entire U.S. market for lumbar fusion procedures. Miles Decl. (Ex. 2030), ¶ 9; Yuan Decl., ¶¶
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`48-49. Indeed, the lack of any anticipatory references in Medtronic’s Petition underscores
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`the novelty of the claimed invention and the fact that this unique combination of features
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`recited in the ‘156 patent claims were never previously implemented in a single implant.
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`Petitioner’s obviousness arguments in this proceeding alleged that traditional
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`posterior lumbar interbody fusion (“PLIF”) implants, such as the Telamon and SVS-PR
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`implants, would be modified to borrow elements of Baccelli’s anterior cervical implant in a
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`way that was never previously conceived or suggested merely because the SVS-PR, the
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`Telamon, and the Baccelli implants are “from the same field of artificial spinal implants used
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`in spinal fusion.” See, e.g., Ex. 1101, ¶¶ 68, 70, 72, 74, 99, 106. This is not enough.
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`Petitioner’s position that it is obvious to create implants with virtually any combination of
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`design features in any orientation ignores the basic fact that interbody fusion implant
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`designers employ a time-consuming and rigorous process of research, testing, and analysis
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`when choosing features, size, and shape for each commercial implant design—all centered
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`on the intended use (insertion approach and final resting position for vertebral fusion) of the
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`implant. See Yuan Decl., ¶ 40; Ex. 2013, ¶ 44:19-47:19. Consequently, ordinary implant
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`designers do not modify, move, or add elements to commercial, FDA-approved interbody
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`fusion implants haphazardly—they require a concrete and important reason to do so.
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`Petitioner’s proposed obviousness grounds include no articulated reasoning with a rationale
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`underpinning to modify the traditional PLIF block implants in a way that would result in the
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`implant of claim 1.
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`II.
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`BOARD’S DECISION TO INSTITUTE REVIEW
`On February 13, 2014, the Board instituted inter partes review of U.S. 8,361,156
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`(“the ‘156 patent”). Based on unrebutted declarant testimony only from Petitioner,1 the
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`Board concluded that Petitioner had demonstrated a “reasonable likelihood” that it will
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`prevail on the challenges and granted review on the following grounds:
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` Claims 1–4, 7, 8, 10–14, 19, 20, 23, 24, 26, and 27 as obvious under 35 U.S.C. §
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`103 by the combination of SVS-PR and Baccelli;
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`1 37 CFR § 42.107(c) prohibits new testimony evidence in the preliminary response.
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` Claims 5, 6, and 9 as obvious under 35 U.S.C. § 103(a) by the combination of SVS-
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`PR, Baccelli, and Michelson;
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` Claim 25 as obvious under 35 U.S.C. § 103(a) by the combination of SVS-PR,
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`Baccelli, and Telamon;
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` Claims 1–4, 7, 10–14, 19, 20, and 23–27 as obvious under 35 U.S.C. § 103(a) by the
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`combination of Telamon and Baccelli; and
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` Claims 5, 6, 8, and 9 as obvious under 35 U.S.C. § 103(a) by the combination of
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`Telamon, Baccelli, and Michelson.
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`Feb. 13, 2014 Decision in IPR2013-00506 (“Decision”), p. 19-20. Throughout the Decision,
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`the Board recognized that Patent Owner only presented attorney argument and noted that
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`there was no supporting evidence. For example, in response to Patent Owner’s argument
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`that one proposed modification would render the SVS-PR implant inoperable for its intended
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`purpose, the Board stated: “[i]t is, therefore, not known, without additional evidence, if the
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`distance from the posterior to anterior edges of the disc space in SVS is less than, equal to,
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`or greater than 40 mm.” Id. at 13. The Board also noted that Patent Owner did not provide
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`evidence “to show that using an implant that is greater than 40 mm in length would” injure
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`the patient. Id. at 13-14 (“without additional evidence”).
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`The Board will find the positions in this Response fully supported by evidence,
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`including the evidence identified as lacking in the Decision.
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`III.
`BACKGROUND
`A.
`Background of modern implant design
`Spinal fusion implants are created via a time-consuming and rigorous process of
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`research, testing, and analysis. Yuan Decl., ¶¶ 39-41; see also Hynes Depo. (Ex. 2013),
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`45:9-46:4, 46:16-47:2. This is most certainly true for commercially available, FDA-approved
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`interbody spinal fusion implants, which have specific sizes, surface features, apertures,
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`tooling engagement structures, and other features specifically associated with the
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`designer’s intended use of the spinal implant. Yuan Decl., ¶¶39-40. In fact, prior to 2004
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`and still to this day, nearly all commercially available spinal implants were provided with
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`surgical “guide” literature so as to instruct spinal surgeons on the intended use of the
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`commercial implant. This was certainly true for the Telamon implant and the SVS-PR
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`implant cited in the Petition. See Ex. 1108 (Telamon “guide”); Ex. 2011 (SVS-PR “guide”).
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`Even slight changes to the design of a commercially available interbody fusion implant,
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`especially the dimensions and marker orientation/positioning, can have a dramatic effect on
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`the functionality and intended use of the implant (and possibly FDA scrutiny), and any
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`ordinary implant designer understands this fact. Yuan Decl., ¶ 40.
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`It is not only important that the implant be designed just right, but it is critical that the
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`implant also be used just right. Yuan Decl., ¶¶ 38-40. Interbody spinal fusion implants and
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`spinal access equipment are designed to be used by average surgeons in specific a
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`medical procedure according to very a specific technique. Yuan Decl., ¶ 39; see also
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`Hynes Depo. 44:9-11. Spinal fusion implants are designed not as universal tools usable by
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`ordinary surgeons to freelance in new and exciting ways. Yuan Decl., ¶ 39. They are
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`designed according to a specific use that is safe, effective, and reproducible in the hands of
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`all surgeons—not just the most highly skilled and experimental group of surgeons, but also
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`the ordinary surgeon that is faithful to the surgical “guide” and other related literature. Yuan
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`Decl., ¶ 39. Surgeons receive extensive training using spinal implants (including the
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`intended approach path to the spine) and spinal access equipment such that every surgeon
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`can follow the procedure to achieve the identical, reproducible result that is (hopefully) safe
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`and very effective. Yuan Decl., ¶¶ 39, 52. This reproducibility is such a critical aspect of
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`interbody fusion implant design because it means not that the procedure might be safe
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`sometimes but that it will be safe in the hands of ordinary surgeons (not just a small group
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`of the most highly skilled spine surgeons). Yuan Decl., ¶¶ 39, 52.
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`Even small design modifications to the dimensions and marker
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`orientation/positioning of an interbody fusion implant make a big difference from a clinical
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`perspective. Yuan Decl., ¶ 40. For interbody fusion implants, it is critically important that
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`the implant fits where it is supposed to fit along the intended insertion path, can be
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`positioned as it is supposed to be positioned, supports the load that it is supposed to
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`support, aligns the spine as it is supposed to align the spine, stays in place where it is
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`supposed to stay, and allows the spine to fuse and heal the way the spine is supposed to
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`fuse and heal. Yuan Decl., ¶ 41. The difference between meeting all of these requirements
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`and meeting only some of them is the difference between having a great implant and having
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`an implant that is unsuitable for its intended purpose. Yuan Decl., ¶ 41. Small design
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`changes to the dimensions and marker orientation/positioning can and do have unintended
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`effects that negatively affect the performance of the spinal interbody fusion implant. Yuan
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`Decl., ¶ 40. This is why ordinary implant designers are so careful about such design
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`changes to commercially available, FDA-approved implants, and would not be prompted to
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`modify such a commercially available implant in a manner that would prevent or otherwise
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`reduce the safety of its original intended use. Yuan Decl., ¶¶ 40, 103, 105.
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`This background is important to understanding how and why persons of ordinary skill
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`in the art design implants the way they do. There are different commercially available
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`implant designs in the prior art (and in this proceeding) not because “any-old-design will
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`work,” but because each particular design was determined to be the right design for that
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`particular intended use set forth in the surgical “guide” literature. Yuan Decl., ¶ 39.
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`Background of implant sizing
`B.
`The size of a spinal interbody fusion implant is extremely important for the
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`performance of the implant and for the intended insertion path of the implant. Yuan Decl.,
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`¶¶35, 39-41. In general, spinal fusion interbody implants need to be small—on the order of
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`millimeters. See e.g. Ex. 1115, claims 5 and 9; Ex. 1105, 10:41-47; Ex. 1106, p. 1; Ex.
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`1107, p. 2. Spinal fusion interbody implants are small for a number of reasons related to
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`human anatomy in and near the spinal column. Yuan Decl., ¶¶ 34, 35. For example, spinal
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`Attorney Docket No: 13958-0116IP2
`fusion interbody implants are designed to reside in the disc space between vertebrae and
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`replace a vertebral disc, which are relatively small in humans (again, on the order of
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`millimeters). See Ex. 1113, p. 4; Yuan Decl., ¶ 30, 34.
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`Vertebral body, Ex. 1113, p. 3
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`Critical anatomy exists near the surgical location, which can force further size
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`constraints. Yuan Decl., ¶¶ 26-30, 34, 35. For example, the spinal cord passes through the
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`spinal canal toward the posterior (rear) portion of the vertebrae. Yuan Decl., ¶ 26, 28.
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`Damaging the spinal cord can paralyze a patient and is a very real risk during spinal fusion
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`procedures. Yuan Decl., ¶ 34, 111. Accordingly, implants (and insertion tools) are sized to
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`avoid contact with the spinal cord during and after implantation. Yuan Decl., ¶ 34, 35. This
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`especially constrains implant size in posterior procedures, such as a PLIF (posterior lumbar
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`interbody fusion) procedure. Yuan Decl., ¶ 35. PLIF procedures for two of the prior art
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`implants (SVS-PR and Telamon) are illustrated below.
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`SVS-PR Implant (Ex. 2011) and Telamon Implant (Ex. 1108)
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`Such PLIF implants are narrow so that two such PLIF implants can be inserted in
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`direct posterior paths on opposite sides of the spinal canal and positioned side by side in
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`the disc space. Yuan Decl., ¶¶ 99, 111-113. The SVS-PR and Telamon implants are
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`reproduced below at actual size2 to illustrate just how small such implants are.
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`SVS-PR Implant (Exhibit 1106) and Telamon Implant (Ex. 1108) (annotated)
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`2 These images are sized so as to be the actual dimension disclosed in Ex. 1106-1108
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`when printed on 8 ½ by 11 inch paper.
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`Critical anatomy also include nerves and nerve roots near the vertebrae, including
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`sensitive nerve roots passing through the psoas muscles lateral to (toward the sides of) the
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`lumbar vertebrae. Yuan Decl., ¶ 26, ; Ex. 2019, Moro et al., An anatomic study of the
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`lumbar plexus with respect to retroperitoneal endoscopic surgery, SPINE Vol. 28 (2003), pp.
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`423, 428 (showing that Medtronic’s agent, Dr. Mathews, expressed the conventional
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`wisdom in the prior art that “surgeons have not felt comfortable with dissecting the psoas
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`because of the presence of the lumbar plexus”). Damaging such nerve roots can also
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`paralyze or otherwise permanently harm a patient. Yuan Decl., ¶49. There are also blood
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`vessels on different sides of the vertebrae, including particularly critical vessels anterior
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`(front) of the vertebrae. Yuan Decl., ¶¶ 26, 34-35. Damaging one of those blood vessels
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`puts a patient’s life at risk. Yuan Decl., ¶¶34-35, 98. Consequently, spinal fusion implants
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`are sized small enough to avoid damaging critical blood vessels and spinal nerves during
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`and after the implantation procedure. Yuan Decl., ¶¶34-35, 48-52, 98, 111.
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`While it is desirable for implants to be large, the implant designs must still facilitate
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`their intended use (PLIF procedure, ALIF procedure, TLIF procedure, etc.) within the
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`anatomical/clinical constraints described above. Yuan Decl., ¶¶ 35, 40-41. Larger spinal
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`fusion implants have a larger footprint and more material for structurally supporting and
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`properly spacing adjacent vertebrae. Yuan Decl., ¶ 41; see also Ex. 1107, p. 2 (advertising
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`“[h]igh ultimate strength” and providing load, fatigue, and stiffness data); Ex. 1106, p. 2
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`(providing data on expulsion strength, compressive strength, fatigue); Ex. 1105, 6:43-57
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`(touting the importance of length and width for creating a “much greater surface area of
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`contact”). If an implant is too small, the implant can fail to properly support the vertebrae
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`and cause pain (for example pinched nerves) that is even greater than the pain the spinal
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`fusion procedure was intended to cure. Yuan Decl., ¶ 41.
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`The conflict between the benefits of a large implant and those of a small implant
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`force designers to undertake critical analysis, research, and testing when designing a spinal
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`fusion implant. Yuan Decl., ¶¶ 39-41. These constraints, in addition to shape requirements
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`that are necessary or desirable for a specific procedure or patient condition as well as other
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`implant features causes the process of designing an implant to be complex and rigid in that
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`even slight changes to the implant dimensions and radiopaque marker structure/positioning
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`can have significant clinical problems. Yuan Decl., ¶40. Determining superior implant
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`dimensions can be an extremely difficult process, especially when attempting to design
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`implants for relatively new spinal fusion procedures that have no conventional implant
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`design to emulate. Yuan Decl., ¶¶ 48-52. There is no guarantee that a designer will get it
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`right. Yuan Decl., ¶¶ 50-52. Indeed, as described below for purposes of a laterally inserted
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`implant, the Michelson patent illustrates several examples of theorized lateral implant
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`designs that were improperly sized and shaped, recognized in the art as unsafe, and never
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`implemented for insertion into a live human patient.
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`In 2004, spinal fusion via a lateral (often called “direct lateral” or “extreme lateral”)
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`access path was one of those procedures without a conventional implant design. Yuan
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`Decl., ¶¶ 48-49. While lateral fusion procedures had been performed by a handful of highly
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`skilled surgeons for years, such procedures were relatively rare and were not performed
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`(especially in the lumbar spine) by ordinary spine surgeons. See, e.g., Yuan Decl., ¶51.
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`This was, in part, due to reluctance by surgeons to traverse the psoas muscle for fear of
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`damaging nerve roots that extend therethrough. Yuan Decl., ¶49; Ex. 2019, p. 428
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`(“surgeons have not felt comfortable with dissecting the psoas because of the presence of
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`the lumbar plexus”). Consequently, there was no appreciable market for lateral spinal
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`fusion implants, and importantly, there was no conventional or standard design at that time.
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`Yuan Decl., ¶¶ 49-52.
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`Dr. Gary Michelson, the inventor of the Michelson patent (Ex. 1105) was one of
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`those people trying to design lateral implants. See Ex. 1105; Yuan Decl., ¶50. There are a
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`number of implant designs illustrated in Michelson (see Ex. 1105, Figs. 1-20) but they were
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`not commercialized, and it is well known to both parties here that not even Dr. Michelson
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`inserted such an implant in a live human patient. Michelson discloses what Dr. Michelson
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`mistakenly believed to be appropriate sizes for lateral implants for use in the lumbar spine
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`for dowel implants (see Ex. 1105, 7:21-26) and for more rectangular implants (see Ex. 1105,
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`10:41-47). But Dr. Michelson’s proposed overall length and width combinations, along with
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`the shapes, for his lateral lumbar implants were recognized in 2004 and earlier as being
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`wrong, unsafe, or both, which is one reason why those proposed sizes are not ultimately
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`practiced in the industry. Yuan Decl., ¶50. The Michelson patent never illustrated any
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`Patent Owner Response
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`Attorney Docket No: 13958-0116IP2
`implant design that was safe and feasible for lateral insertion, so even in the “post-
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`Michelson” (a new term used repeatedly by the Petitioner) time frame before 2004, the
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`industry was left with nothing more than wrong answers and a general avoidance by
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`average spine surgeons of any lateral, trans-psoas surgeries. Dr. Michelson’s sizes are
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`also not the sizes disclosed in the ‘156 patent for a laterally insertion implant, as will be
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`discussed below. Yuan Decl., ¶¶ 90-91. Michelson is, therefore, one example of the
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`reality that knowing an intended direction of insertion for a spinal fusion implant does not
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`make it easy (or obvious) to select appropriate implant dimensions. Yuan Decl., ¶¶50-52.
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`Background of radiopaque implant markers
`C.
`Radiopaque markers are called “radiopaque” because they are “opaque” when
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`viewed via X-ray imaging. Yuan Decl., ¶¶42-46; Ex. 1115, FIG. 21. Patent Owner does not
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`dispute that radiopaque markers have long been used in implantable medical devices to
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`show positioning of such devices, both during and after the implantation procedure.
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`Radiopaque markers are traditionally positioned at the extremities of spinal implants to
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`show the location of those extremities. Yuan Decl., ¶45. For example, elongated implants
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`such as the Telamon and SVS-PR would traditionally include a radiopaque marker at each
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`lengthwise end. Yuan Decl., ¶¶ 78-82 and 83-86. These two markers allow the surgeon to
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`ensure that each end is at the appropriate position with respect to the vertebrae, usually
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`along a hardened bone region near the rim of the vertebrae. Yuan Decl., ¶¶ 81 and 86.
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`Patent No. 8,361,156
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`Case IPR2013-00506
`Patent Owner Response
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`Attorney Docket No: 13958-0116IP2
`Dr. Hynes also confirmed that putting “one on one end and one on the other end” of
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`a PLIF implant is what he would do and “what’s commonly done.” Hynes Depo., 138:16-22.
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`Dr. Hynes explained the purpose of putting radiopaque markers at each lengthwise end of a
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`PLIF implant as follows: “if you have one marker on the other end, then you can follow the
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`distal or the leading edge in and see where it is and then you have a marker on the trailing
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`end and see where it ends up.” Hynes Depo., 142:1-5. Dr. Hynes further explained that
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`ordinary surgeons would also “pick the front and the back in the direction of insertion. It's
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`just intuitive, but it's also safer for the patient.” Hynes Depo., 142:8-12.
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`The location of implant markers is very intentional to convey specific information to
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`the implanting surgeons. Yuan Decl., ¶46. While it is technically possible from a
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`manufacturing standpoint to add radiopaque markers to a PEEK implant in virtually an
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`infinite number of different positions, the positions actually selected are very deliberate and
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`purposeful based upon the original intended use (insertion path and final resting position) of
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`the implant. Yuan Decl., ¶¶ 45-46. Because of this, extra markers are simply not added
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`without a specific purpose. Id. The testimony evidence here from both parties shows the
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`agreement that excess markers positioned in an implant at unnecessary locations can
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`clutter and confuse x-ray imaging viewed by the surgeon. Yuan Decl., ¶¶ 45-46, 98-99, and
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`102; Hynes Depo., 163:23-164:25. Indeed, when asked about adding additional markers
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`across the medial center of a traditional PLIF implant, Dr. Hynes also agreed that such
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`Patent No. 8,361,156
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`Case IPR2013-00506
`Patent Owner Response
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`Attorney Docket No: 13958-0116IP2
`additional markers could create redundancy or confusion. Hynes Depo., 163:23-164:25.
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`Dr. Hynes explained:
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`What happens is the wrong marker, the size of the marker, direction of the
`marker, and the wrong place actually creates confusion sometimes. You'd
`see less. Sometimes less is better. We have to look at it.
`And so there's all kinds of combinations you could use and we could make
`them different sizes, different shapes, but then you start getting too much
`information and it actually gives you a less information.
`Hynes Depo., 164:10-19 (emphasis added). In order to convey specific information without
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`creating confusion, designers carefully and critically select the number and location of
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`radiopaque markers in each implant based upon the implant’s intended clinical use, not
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`merely because a metallic marker could be manufactured anywhere into a plastic structure.
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`Yuan Decl., ¶ 46. The number and position of radiopaque markers in a radiolucent implant
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`is dictated and limited by the intended clinic use of that implant, not by manufacturing
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`capabilities. Petitioner, and its alleged expert Dr. Hynes, appear to ignore this reality of
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`interbody fusion implant design. Hynes Depo., 140:23-141:13 (relying on the possible
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`manufacturing simplicity, not the clinical purpose of such markers, and stating “[t]hey’re [the
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`markers are] easy to put in….You can have any choice you want.”)
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`Background of the ‘156 patent
`D.
`The claims of the ‘156 patent do not broadly claim all lateral fusion implants. They
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`do not claim all radiolucent implants having multiple radiopaque markers. They do not claim
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`Patent No. 8,361,156
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`Case IPR2013-00506
`Patent Owner Response
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`Attorney Docket No: 13958-0116IP2
`any type of PLIF implant or anterior implant (and in fact recite features that are not, and
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`would not be, collectively provided in any PLIF implant or anterior implant). To be clear, the
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`‘156 patent claims are specifically and reasonably tailored to a unique combination of
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`features collectively provided in a spinal implant for insertion in a lateral, trans-psoas
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`surgical approach path. Yuan Decl., ¶ 47. The implant depicted in Figs. 2-6, 20, and 21 of
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`the ‘156 patent is NuVasive’s CoRoent XL implant. Yuan Decl., ¶ 53. The CoRoent XL
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`implant is not just illustrated, but also has all of the features claimed in claim 1 and many of
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`the dependent claims of the ‘156 patent. Yuan Decl., ¶¶ 53-63. The CoRoent XL implant
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`has a unique combination of features including the size, shape, and orientation of the
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`support structure and alignment markers, and was the first lateral, trans-psoas fusion
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`implant that achieved commercial success, and indeed changed the entire U.S. market for
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`lumbar fusion procedures. Yuan Decl., ¶¶ 47 and 53-63; Miles Decl., ¶¶ 7-10 and App. A.
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`Prior to Patent Owner (“NuVasive”) developing the implant depicted in the ‘156
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`patent, virtually all lumbar fusion surgeries actually performed in the U.S. used implants that
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`approached the spine from the rear (posterior or posterolateral approaches) or from the
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`front (anterior or anterolateral approaches)—approach paths that avoided the risks of the
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`psoas muscle and the required implant structures of smaller sizes and different shapes.
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`Yuan Decl., ¶¶ 48-49; see also Ex. 2019, p. 428 (“surgeons have not felt comfortable with
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`dissecting the psoas because of the presence of