UNITED STATES PATENT AND TRADEMARK OFFICE
`
`________________
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`________________
`
`
`ALPHATEC HOLDINGS, INC. AND ALPHATEC SPINE, INC.
`Petitioner,
`
`
`v.
`
`
`NUVASIVE, INC.
`Patent Owner.
`________________
`
`Case No. IPR2019-00362
`U.S. Patent No. 8,361,156
`
`________________
`
`
`DECLARATION OF CHARLES L. BRANCH, JR., M.D. IN SUPPORT OF
`PETITION FOR INTER PARTES REVIEW OF
`U.S. PATENT NO. 8,361,156
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`United States Patent and Trademark Office
`PO Box 1450
`Alexandria, Virginia 22313–1450
`Submitted Electronically via the Patent Review Processing System
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1002, p. 1 of 119
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`TABLE OF CONTENTS
`
`Page
`
`
`I.
`SCOPE OF ASSIGNMENT ............................................................................ 1
`II. QUALIFICATIONS ........................................................................................ 2
`III. MATERIALS CONSIDERED ........................................................................ 4
`IV. LEVEL OF ORDINARY SKILL IN THE ART ............................................. 5
`V.
`SUMMARY OF THE ’156 PATENT AND ITS TECHNICAL FIELD ........ 6
`A. Overview of the human spine. ............................................................... 6
`B.
`Interbody spinal fusion procedures and implants. .............................. 11
`C.
`The ’156 patent. ................................................................................... 16
`VI. CLAIM INTERPRETATION ....................................................................... 24
`VII. LEGAL STANDARDS ................................................................................. 24
`A. Obviousness ......................................................................................... 24
`VIII. OVERVIEW OF THE REFERENCES ......................................................... 28
`A. U.S. Patent No. 5,192,327 (“Brantigan”) ............................................ 28
`B.
`Berry et al. “A Morphometric Study of Human Lumbar and
`Selected Thoracic Vertebrae,” 12 Spine, 362–367 (1987) (“Berry”) . 31
`C. U.S. Patent App. Pub. No. 2003/0028249 (“Baccelli”) ...................... 33
`D. U.S. Patent No. 5,860,972 (“Michelson ’973”) .................................. 34
`IX. ANALYSIS OF THE CHALLENGED CLAIMS OF THE ’156
`PATENT ........................................................................................................ 38
`A.
`The challenged claims ......................................................................... 38
`INVALIDITY ................................................................................................ 38
`A. Ground 1: claims 1-3, 5, 9–10, 12-21, 23–24, and 27 are rendered
`obvious by Brantigan in view of Baccelli and Berry .......................... 38
`1.
`Claim 1 ...................................................................................... 45
`2.
`Claim 2 ...................................................................................... 75
`3.
`Claim 3 ...................................................................................... 77
`4.
`Claim 5 ...................................................................................... 78
`5.
`Claim 9 ...................................................................................... 82
`6.
`Claim 10 .................................................................................... 83
`7.
`Claim 12 .................................................................................... 84
`8.
`Claim 13 .................................................................................... 85
`
`X.
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`ii
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
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`Claim 14 .................................................................................... 87
`9.
`10. Claim 15 .................................................................................... 88
`11. Claim 16 .................................................................................... 90
`12. Claim 17 .................................................................................... 91
`13. Claim 18 .................................................................................... 93
`14. Claim 19 .................................................................................... 95
`15. Claim 20 .................................................................................... 96
`16. Claim 21 .................................................................................... 98
`17. Claim 23 ..................................................................................100
`18. Claim 24 ..................................................................................101
`19. Claim 27 ..................................................................................104
`B. Ground 2: claim 9 is rendered obvious by Brantigan in view of
`Baccelli, Berry, and Michelson ’973 .................................................105
`20. Claim 9 ....................................................................................106
`XI. SECONDARY CONSIDERATIONS .........................................................111
`XII. CONCLUSION ............................................................................................111
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
`IPR2019-00362, Ex. 1002, p. 3 of 119
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`Exhibit No.
`1001
`1002
`1003
`1004
`
`1005
`
`1006
`
`1007
`1008
`1009
`1010
`1011
`1012
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`1018
`
`1019
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`
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`TABLE OF EXHIBITS
`
`PETITIONER’S EXHIBIT LIST
`Brief Description
`U.S. Patent No. 8,361,156 to Curran et al. (“’156 patent”)
`Declaration of Charles L. Branch, Jr., M.D.
`Curriculum Vitae of Charles L. Branch, Jr., M.D.
`IPR2013-00506, Final Written Decision, Paper No. 47 (“IPR506
`FWD”)
`In re: NuVasive, Inc., No. 2015-1670, Opinion, (Fed. Cir. Dec. 7,
`2016) (“IPR2013-00506 CAFC Opinion”)
`IPR2013-00506, Judgment Granting Joint Motion to Terminate
`after Remand from the Court of Appeals for the Federal Circuit,
`Paper No. 57
`U.S. Patent No. 5,192,327 to Brantigan (“Brantigan”)
`U.S. Patent App. Pub. No. 2003/0028249 to Baccelli et al.
`(“Baccelli”)
`Synthes Vertebral Spacer-PR Brochure (“SVS-PR”)
`Telamon Verte-Stack PEEK Vertebral Body Spacer Brochure
`(“Telamon Brochure”)
`Telamon Implantation Guide (“Telamon Guide”)
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 2013-1576, -1577,
`Joint Appendix, Docket No. 52-1 (Fed. Cir. June 16, 2014)
`Prosecution History of the ’156 patent, U.S. App. No. 13/441,092
`IPR2013-00208, Corrected Petition for Inter Partes Review of
`United States Patent No. 8,251,997, Paper No. 5 (“IPR208
`Petition”)
`IPR2013-00206, Corrected Petition for Inter Partes Review of U.S.
`Patent No. 8,251,997, Paper No. 5 (“IPR206 Petition”)
`IPR2013-00206, Petitioner’s Reply to Patent Owner’s Response,
`Paper No. 43, (“IPR206 Reply”)
`IPR2013-00206, Final Written Decision, Paper No. 65 (“IPR206
`FWD”)
`IPR2013-00208, Final Written Decision, Paper No. 62 (“IPR208
`FWD”)
`In re: Warsaw Orthopedic, Inc., Nos. 2015-1050, 2015-1058 (Fed.
`Cir. Aug. 9, 2016) (“IPR208 CAFC opinion”)
`
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`iv
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`Exhibit No.
`1020
`1021
`1022
`
`1023
`
`1024
`
`1025
`1026
`1027
`1028
`1029
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`1030
`
`1031
`1032
`1033
`1034
`1035
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`1036
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`1037
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`1038
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`1039
`1040
`1041
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`PETITIONER’S EXHIBIT LIST
`Brief Description
`Prosecution History of U.S. Patent No. 7,918,891, U.S. App. No.
`11/093,409
`U.S. Patent No. 8,251,997 to Michelson (“Michelson ’997”)
`Berry et al. “A Morphometric Study of Human Lumbar and
`Selected Thoracic Vertebrae,” 12 SPINE, 362-367 (1987) (“Berry”)
`Prosecution History of U.S. Patent No. 8,187,334, U.S. App. No.
`13/079,645
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 3:08-cv-1512
`CAB-MDD, NuVasive Inc.’s Memorandum of Points and
`Authorities in Support of its Renewed Motion for Judgment as a
`Matter of Law or a new Trial, Docket No. 407-1 (S.D. Cal. Oct. 27,
`2011) (“Warsaw JMOL”)
`Prosecution History of U.S. Patent No. 8,246,686, U.S. App. No.
`13/440,062
`U.S. Provisional Patent App. No. 60/557,536, filed March 29, 2004
`RESERVED
`U.S. Patent No. 5,127,912 to Ray et al.
`U.S. Patent No. 5,514,180 to Heggeness et al.
`Amonoo-Kuofi, “Age-Related Variation in the Horizontal and
`Vertical Diameters of the Pedicles of the Lumbar Spine,” 186 J.
`ANAT., 321-328 (1995)
`IPR2013-00506 Decision to Institute, Paper No. 9
`U.S. Patent No. 5,860,973 to Michelson (“Michelson ’973”)
`IPR2013-00504, Decision Denying Institution, Paper No. 8
`IPR2013-00506, Petition, Paper No. 1
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 2013-1576, -1577,
`NuVasive’s Opening Brief, Docket No. 33 (Fed. Cir. Feb. 3, 2014)
`Panjabi et al., “Complexity of the Thoracic Spine Pedicle
`Anatomy,” 6 EUR. SPINE J., 19-24 (1997)
`Kopperdahl et al., “Yield Strain Behavior of Trabecular Bone,” 31
`J. BIOMECHANICS, 601-608 (1998)
`IPR2013-00208, Declaration of Dr. Paul McAfee, M.D., M.B.A.,
`Paper No. 1001
`NuVasive Inc. v. Medtronic, Inc., No. 2015-1670, Corrected
`NuVasive’s Opening Brief, Docket No. 19 (Fed. Cir. July 23, 2015)
`U.S. Patent Application No. 2002/0165550 to Frey et al.
`IPR2013-00504, Petition, Paper No. 3
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`v
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`Exhibit No.
`1042
`1043
`1044
`1045
`1046
`
`1047
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`PETITIONER’S EXHIBIT LIST
`Brief Description
`IPR2014-00487, Petition, Paper No. 1
`IPR2013-00506, Patent Owner Response, Paper No. 21
`IPR2014-00487, Decision Denying Institution, Paper No. 8
`Reserved
`Warsaw Orthopedic, Inc. v. NuVasive, Inc., No. 2013-1576, 2013-
`1577, Opinion, Docket No. 77 (Fed. Cir. March 2, 2015)
`IPR2013-00208, Petitioner’s Reply to Patent Owner’s Response,
`Paper No. 40
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`vi
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC.
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`I Charles L. Branch, Jr., M.D., of Winston-Salem, North Carolina hereby
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`declare under penalty of perjury:
`
`I.
`
`SCOPE OF ASSIGNMENT
`1.
`I serve as Professor and Chairman of the Department of Neurosurgery
`
`at Wake Forest University School of Medicine. As discussed below, my practice,
`
`teaching, and research interests have focused upon the treatment of spinal diseases
`
`and injuries.
`
`2.
`
`I have been retained on behalf of Alphatec Holdings, Inc. and Alphatec
`
`Spine, Inc. (collectively, “Alphatec”) to provide my independent opinions regarding
`
`the validity of claims 1–3, 5, 9–10, 12–21, 23–24, and 27 of United States Patent
`
`No. 8,361,156 (the “’156 patent”).
`
`3.
`
`In forming my opinions as set forth in this Declaration, I have relied
`
`upon my education, research, training, and decades of experience in the area of
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`spinal surgery and spinal fusion surgery. I have also relied upon my review and
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`analysis of the prior art and information provided to me in connection with this case.
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`4.
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`I am being compensated for my services and reimbursed for reasonable
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`expenses that I may incur while working on this matter. This compensation does not
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`depend in any way on the conclusions I reach.
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`II. QUALIFICATIONS
`5.
`Presently, I am the Eben Alexander, Jr. Professor and Chair,
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`Department of Neurosurgery, Wake Forest School of Medicine, and Co-Chair,
`
`Neuroscience Service Line, Wake Forest Baptist Medical Center. I have completed
`
`a second term as a member of the Governing Board of the School of Biomedical
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`Engineering of Wake Forest University and Virginia Polytechnic Institute, and am
`
`in my fourth term as member of the Board of Regents of Pepperdine University. I
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`also serve as a founding Director of the Collaborative Spine Research Foundation, a
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`multidisciplinary effort to establish funding resources for clinical spine research.
`
`6.
`
`I received my Doctorate of Medicine from University of Texas
`
`Southwestern Medical University in 1981. My postdoctoral training included an
`
`internship at the Department of General Surgery at North Carolina Baptist Hospital
`
`from 1981-1982; a residency, Section on Neurosurgery, North Carolina Baptist
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`Hospital from 1982-1987, under Dr. David L. Kelly, Jr.; a rotation in Neurosurgery
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`at the Mayo Clinic in Rochester, Minnesota in January 1985, under Dr. Edward
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`Laws; a chief residency, Section on Neurosurgery, Bowman Gray School of
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`Medicine in Winston-Salem, North Carolina from 1985-1986, under Dr. David L.
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`Kelly, Jr.; and a Clinical Fellowship as Chief Resident in the Department of
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`Neurological Surgery at the University of California in San Francisco, from July
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`1987-September 1987, under Dr. Charles B. Wilson.
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`7.
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`I have been licensed to practice medicine for more than 30 years and
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`hold medical licenses in Texas and North Carolina. I also hold a specialty
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`certification from the American Board of Neurological Surgery.
`
`8.
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`I have been teaching spinal surgery since 1987, and have held various
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`academic appointments during that time at the Wake Forest School of Medicine,
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`Department of Neurosurgery. In June, 2000, I was appointed to the position of the
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`Eben Alexander, Jr. Professor and Chair, Department of Neurosurgery, Wake Forest
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`School of Medicine. Additionally, I have held numerous visiting faculty positions.
`
`9. My practice and research have focused on the treatment of spinal
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`diseases and injuries. In particular, I have dedicated much of my career to the
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`enhancement and education of minimally invasive Lumbar Interbody Fusion
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`techniques from a variety of approaches. These techniques are used by spine
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`surgeons worldwide.
`
`10.
`
`I have served as Chairman of the American Board of Neurological
`
`Surgery, President of the North American Spine Society, and Chairman of the
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`AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves.
`
`11.
`
`I am the principal author or co-author of more than 95 journal articles,
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`chapters, abstracts, and related publications, and have given over 150 lectures and
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`oral presentations worldwide on various topics related to my practice, teaching, and
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`research interests.
`
`
`
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`3
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`12.
`
`I have served as Editor-in-Chief of The Spine Journal, and have held
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`editorial board positions for various other publications including Journal of
`
`Neurosurgery: Spine, Neurosurgery, Clinical Orthopaedics and Related Research,
`
`Journal of Radiosurgery, Neurosurgical Focus, Journal of Spinal Disorders, and
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`Spinal Surgery: Official Journal of the Japanese Society of Spinal Surgery.
`
`13.
`
`I am a named inventor or co-inventor on U.S. Patent No. 6,174,311
`
`(Interbody Fusion Grafts and Instrumentation); U.S. Patent No. 6,193,757
`
`(Expandable Intervertebral Spacers); U.S. Patent No. 6,200,322 (Minimal Exposure
`
`Posterior Spinal Interbody Instrumentation and Technique); and 37 other U.S. and
`
`European patents related to spinal surgery, spinal implants, and spinal surgical
`
`instrumentation. My inventive and product development activities have focused on
`
`developing technologies that can be made available for use by myself and other
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`surgeons in clinical settings to improve patient care and outcomes.
`
`14. A true and correct copy of my curriculum vitae, which provides
`
`additional details regarding my background and experience, is being submitted
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`concurrently with this declaration as Ex. 1003.
`
`III. MATERIALS CONSIDERED
`15.
`In developing the opinions expressed below relating to the ’156 patent,
`
`I have read the claims, specification, and prosecution history of the ’156 patent. I
`
`have also considered the materials cited herein, including those identified in the
`
`
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`4
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`“Petitioner’s Exhibit List” above. I have also relied on my decades of knowledge
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`and experiences obtained by working and teaching in the field.
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`IV. LEVEL OF ORDINARY SKILL IN THE ART
`16. Petitioner’s counsel asked me to describe the qualifications of a person
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`of ordinary skill in the art (“POSA”) regarding the claimed subject matter. I
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`understand that a person of ordinary skill in the art is a hypothetical person
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`considered to have normal skills and knowledge in the field to which the patent
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`relates at the time of the earliest effective filing date, which I understand is claimed
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`to be March 29, 2004. I have not been asked to evaluate whether the ’156 patent
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`claims are actually entitled to claim priority to that date.
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`17. To determine the level of skill in the art, Petitioner’s counsel informed
`
`that I should consider the following factors: (1) the education level of the inventor;
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`(2) types of problems encountered in the art; (3) prior art solutions to these problems;
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`(4) rapidity with which innovations were made; (5) sophistication of the technology;
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`and (6) education level of active workers in the field. I have considered the above
`
`factors and drawn on my experiences with working groups in the field to make a
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`determination as to the level of ordinary skill.
`
`18. At the time of the invention alleged in the ’156 patent, a person having
`
`ordinary skill in the art (“POSA”) would have a medical degree with two to three
`
`years’ experience performing procedures using interbody spinal fusion implants.
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`5
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`Alternatively, a POSA would have a mechanical or biomechanical engineering
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`degree with at least two years’ experience working in developing implant devices
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`and associated instruments with significant access to orthopedic surgeons or
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`neurosurgeons. This is based on my familiarity teaching and working with those of
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`ordinary skill in the art as of 2004.
`
`V.
`
`SUMMARY OF THE ’156 PATENT AND ITS TECHNICAL FIELD
`19. An overview of the relevant anatomy, pathologies, and technological
`
`background is helpful to understand the technology described in the ’156 patent. I
`
`provide that overview here.
`
`A. Overview of the human spine.
`20. The ’156 patent relates to generic spinal fusion implants. In order to
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`discuss the disclosure of the ’156 patent, it is first useful to present an anatomical
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`summary of the human spine.
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`21. The human spine, also called the vertebral column, is made up of 26
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`bones: 24 vertebrae, the sacrum, and coccyx. As shown in the image below, the
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`vertebral column—and associated vertebrae—contains different regions. Those
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`regions include the cervical vertebrae of the head and neck, the thoracic vertebrae of
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`the mid-back, and the lumbar vertebrae of the lower back. Vertebrae are typically
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`referred to by region and number. Thus, “T2” refers to the second vertebra in the
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`thoracic region, while “L2” refers to the second vertebra in the lumbar region.
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`22. The vertebrae form a support column that carries the overall weight of
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`the trunk, neck, and head, distributing their weight to the lower limbs. In addition,
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`the spine functions to protect the spinal cord.
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`
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`23. Each individual vertebra is composed of three principal elements: (1) a
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`body, (2) a vertebral arch, and (3) articular processes. The vertebral body distributes
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`weight along the vertebral column’s axis. The vertebral bodies are separated from
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`adjacent vertebrae by intervertebral discs. The vertebral body includes upper and
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`lower endplates in contact with the intervertebral discs. Corresponding to the size
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`of the vertebrae, the size of the intervertebral disc space increases from the cervical
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`through the thoracic and to the lumbar regions.
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`7
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`24. The intervertebral disc is made up of collagen ligament material,
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`mucinous material (disc material), articular cartilage, fibrocartilage, and adheres to
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`the bony endplate. The intervertebral discs serve to absorb shock imparted to the
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`spinal column and afford a degree of movement between adjacent vertebrae.
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`25. One of the leading causes of lower back pain and disability results from
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`the rupture or degeneration of one or more lumbar discs in the spine. Pain and
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`instability are caused by compression of the spinal nerve roots because the damaged
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`discs protrude into the vertebral canal and do not provide sufficient biomechanical
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`support for the full range of vertebral motion.
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`26. Normally intervertebral discs, which are located between endplates of
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`adjacent vertebrae, stabilize the spine and distribute forces between the vertebrae
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`and cushion vertebral bodies. An intervertebral disc includes a semi-gelatinous
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`component—the nucleus pulposus, and a fibrous ring—the annulus fibrosis. The
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`spinal discs may be displaced or damaged due to trauma, disease or aging. A
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`herniated or ruptured annulus fibrosis may result in nerve damage, pain, numbness,
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`muscle weakness, and even paralysis.
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`27. The size and shape of the vertebral body varies along the length of the
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`spinal column. For example, thoracic vertebral bodies are larger than those in the
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`cervical region, and are slightly compressed in shape. Thoracic vertebrae also have
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`structures known as facets where ribs attach. Lumbar vertebrae carry the greatest
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`8
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`amount of human body weight and have the largest size and thickness of the
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`vertebral bodies. Moreover, lumbar vertebrae have short transverse processes
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`compared to the thoracic region. Cervical (top), thoracic (middle), and lumbar
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`(bottom) vertebral bodies are illustrated below:
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`9
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`28. An “anatomical plane” is a hypothetical plane used to transect the
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`human body in order to facilitate discussion about the location and orientation of
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`various structures relative to the human anatomy.
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`29. The following diagram shows the major anatomical planes, including
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`what are commonly referred to as the sagittal, coronal, and transverse planes.
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`10
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`30. The sagittal plane is also known as the medial plane, and it divides the
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`body into left and right. The coronal plane divides the body into front and back, i.e.,
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`anterior and posterior, respectively. And the transverse plane, also known as the
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`axial plane, divides the body into head and tail portions.
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`B.
`Interbody spinal fusion procedures and implants.
`31. The ultimate objective of spinal implant fusion procedures is to
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`facilitate the promotion of bone growth between adjacent vertebrae in an
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`anatomically satisfactory configuration. Such bone growth serves in joining or
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`fusing adjacent vertebrae together and can occur in the spaces formerly occupied by
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`the intervertebral discs.
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`11
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`32. By joining or fusing adjacent vertebrae, the vertebrae can be
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`immobilized with respect to one another to improve stability of the spine, lessen
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`trauma to surrounding structures, and restore lordosis between adjacent vertebrae.
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`The space between adjacent vertebra is known as the “interbody space.”
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`33. Historically, spinal fusion utilized bone, either bone from the patient—
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`known as autogenous bone—or bone from another human—known as allograft
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`bone. Eventually, spinal fusion evolved and expanded to utilize implants made from
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`non-bone material, including titanium and carbon fiber.
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`34. Today, spinal fusion is performed predominantly using spinal fusion
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`implants. Such spinal fusion implants can be positioned between adjacent vertebrae
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`in the interbody space formerly occupied by the intervertebral discs. Bone growth
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`between the adjacent vertebrae into and through the spinal fusion implants serves to
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`join or fuse the vertebrae to one another. Thus, as commonly understood, a spinal
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`fusion implant participates in bony fusion of adjacent vertebrae via bone growth
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`between the adjacent vertebrae into and through the spinal fusion implant.
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`35.
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`In the 1950s, Robert Cloward first described removing blocks of bone
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`from the patient’s hip (iliac crest autograft) and inserting them into the disc space.
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`With his publication, posterior lumbar interbody fusion techniques were popularized
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`and fusion rates greatly improved. During the 1980s, Dr. Cloward and others
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`developed supplementary spinal fusion interbody implants and stabilizing posterior
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`fixation. These further improved fusion rates and popularized the technique.
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`36. By the late 1980s, Bagby reported the use of a stainless steel cylinder,
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`the Bagby Basket, as a spinal fusion interbody implant. Bagby’s system could be
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`packed with ground-up autogenous bone inside the and around the device. Bagby’s
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`system improved fusion rates and preserved normal disc space height, which helped
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`with exiting nerve root decompression and stabilization.
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`37. The stainless steel cylinders, however, did not mimic the modulus
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`elasticity of natural bone, which resulted in a “subsidence” problem, where the
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`interbody spinal fusion implants sank into the softer bone.
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`38.
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`In the late 1980s, and given the rapid development in the field, there
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`was a need for accurate anatomic descriptions of vertebral shape to coincide with
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`the development of implantable devices and spinal instrumentation. Berry and his
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`group filled this need by conducting a study that directly measured 27 vertebral
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`dimensions from human skeletons and various points throughout the human
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`vertebral column.
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`39. By the 1990s, the use of non-bone interbody spinal fusion implants had
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`become common place. During this time, Dr. Brantigan and others introduced
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`synthetic interbody devices called “cages.”
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`40. Well before March 2004, available spinal fusion interbody implants
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`were primarily carbon fiber reinforced polymers (CF-P), titanium (Ti) and
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`polyetheretherketone (PEEK). Surgeons were able to achieve high rates of fusion
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`with PEEK early on, which became the preferred material.
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`41. PEEK is a thermoplastic known for its mechanical and chemical
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`resistance properties that hold even at high temperatures. Because of its potential
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`for high-load and high-temperatures, PEEK became a candidate for use in medical
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`devices.
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`42. PEEK is especially good for implants because of its superior elastic
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`modulus. PEEK has modulus of elasticity more similar to that of bone, which
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`mitigated the problem of subsidence.
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`43. PEEK also had the recognized advantage of radiolucency (being
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`transparent to X-rays). In postoperative radiographs, the outlines of radiolucent
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`cages become increasingly apparent as the adjacent bone graft consolidates over
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`time. These advantages were known well before 2004.
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`44. PEEK cages were commercially introduced in the 1990s by AcroMed
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`as an alternative to titanium cages. Development of such devices began at least as
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`early as the late 1990s.
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`45.
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`In fact, I was personally involved with the development and launch of
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`a number of radiolucent cages in the late 1990s and early 2000s, including Telamon
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`Verte-Stack PEEK Vertebral Body Spacer manufactured by Medtronic (2003).
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`Synthes had also launched a lumbar interbody fusion cage called Vertebral Spacer-
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`PR around the same time (2002). Medtronic had launched a number of PEEK spinal
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`fusion interbody cages by the early 2000s, with which I am very familiar.
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`46. One problem associated with spinal fusion implants fabricated solely
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`from PEEK was the inability for the surgeon to understand the location of the
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`implant during or after surgery, which was especially problematic for lateral
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`insertion techniques where direct visualization was limited.
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`47. A solution to this problem arose through incorporation of radiopaque
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`markers into purely radiolucent implants. Incorporation of these markers into
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`various locations in the implant, e.g., anterior and posterior sidewalls, allowed a
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`surgeon to determine whether the implant was properly seated in the vertebral space.
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`48. The need for radiopaque markers for use in surgery had been known for
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`some time. Because the radiolucent cages were transparent to X-rays, most
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`contained at least two radiopaque markers to enable radiographic assessment of the
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`spacer position. Indeed, all of the PEEK cages I described above, for example,
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`Synthes’ Vertebral Spacer-PR and Telamon, which launched in 2002 and 2003,
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`respectively, contained such markers. The benefits of including radiopaque markers
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`in radiolucent spinal fusion interbody cages were thus known well before March
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`2004.
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`49. For example, observing a posterior marker located at least 2 mm
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`anterior to the posterior vertebral body margin provides reassurance that the
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`interbody implant is not protruding into the spinal canal. For a laterally inserted
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`implant, it was known that location of a marker centrally along the length of the
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`implant would enable a surgeon to properly align the implant relative to the spinous
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`process. As the shape and structures of the human spine were known, as was the
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`ability to see radiopaque materials in an X-ray, a POSA would have had a reasonable
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`expectation that including radiopaque markers in the center of the anterior and
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`posterior walls of a lateral implant, for example, would provide specific beneficial
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`information to the surgeon.
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`C. The ’156 patent.
`50. The ’156 patent, entitled “Systems and Methods for Spinal Fusion,”
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`issued on January 29, 2013 from Application No. 13/441,092 filed on April 6, 2012.
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`51.
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`I understand that the application leading to the ’156 patent is a
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`continuation of U.S. Patent No. 8,246,686, filed on April 5, 2012, which is a
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`continuation of U.S. Patent No. 8,187,334, filed on April 4, 2011, which is a
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`continuation of 7,918,891, filed on March 29, 2005, which claims the benefit U.S.
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`Provisional Application Ser. No. 60/557,536, filed on March 29, 2004.
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`52. The ’156 patent’s Abstract indicates that it relates to, “A system and
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`method for spinal fusion comprising a spinal fusion implant of non-bone
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`construction releasably coupled to an insertion instrument dimensioned to introduce
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`the spinal fusion implant into any of a variety of spinal target sites.” Ex. 1001, Abst.
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`53. The ’156 patent’s Field of the Invention indicates that the patent
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`broadly relates to generic interbody spinal fusion implants: “The present invention
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`relates generally to spinal surgery and, more particularly, to a system and method
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`for spinal fusion comprising a spinal fusion implant of non-bone construction
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`releasably coupled to an insertion instrument dimensioned to introduce the spinal
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`fusion implant into any of a variety of spinal target sites.” Ex. 1001, 1:20–24.
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`54.
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`In describing the prior art, the ’156 patent states that “there are nearly
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`500,000 spine lumbar and cervical fusion procedures performed each year in the
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`United States … to correct problems, such as chronic back or neck pain, which result
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`from degenerated intervertebral discs or trauma.” Ex. 1001, 1:27–30. The ’156
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`patent states that “spinal fusion procedures involve removing some or all of the
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`diseased or damaged disc, and inserting one or more intervertebral implants into the
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`resulting disc space.” Ex. 1001, 1:31–33. The ’156 patent states that these