UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`NUVASIVE, INC.
`Petitioner
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`v.
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`WARSAW ORTHOPEDIC, INC.
`Patent Owner
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`Patent Number: 8,251,997 B2
`Issue Date: August 28, 2012
`Title: METHOD FOR INSERTING AN ARTIFICIAL
`IMPLANT BETWEEN TWO ADJACENT VERTEBRAE
`ALONG A CORONAL PLANE
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`____________
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`Case IPR2013-00206
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`WARSAW’S PATENT OWNER RESPONSE
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`I.
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`II.
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`TABLE OF CONTENTS
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`INTRODUCTION ........................................................................................... 1
`
`OVERVIEW OF U.S. PATENT NO. 8,251,997 ............................................ 2
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`A.
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`Summary of the ’997 Patent .................................................................. 3
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`1.
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`2.
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`3.
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`Advantages over prior art implants and methods ....................... 4
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`Dr. Michelson’s claimed implant ................................................ 5
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`Dr. Michelson’s “true” lateral method ........................................ 7
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`III. BOARD’S DECISION TO INSTITUTE REVIEW ....................................... 8
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`IV. CLAIM CONSTRUCTION .......................................................................... 10
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`A.
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`“a path having an axis lying in a coronal plane passing through
`a lateral aspect and a medial aspect of the two adjacent
`vertebrae and anterior to the transverse processes” ............................ 10
`
`B.
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`“elongated portion” ............................................................................. 12
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`V.
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`PETITIONER’S PRIOR ART DOES NOT DISCLOSE A DIRECT
`OR “TRUE” LATERAL APPROACH FOR PERFORMING
`INTERBODY SPINAL FUSION, MUCH LESS THE CLAIMED
`IMPLANT ...................................................................................................... 14
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`A.
`
`B.
`
`The State of the Relevant Prior Art ..................................................... 15
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`Jacobson .............................................................................................. 19
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`1.
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`2.
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`Jacobson does not disclose direct lateral. ................................. 19
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`Jacobson does not disclose the insertion of an implant. ........... 24
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`C.
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`Brantigan ............................................................................................. 26
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`1.
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`Brantigan does not disclose the lateral insertion of an
`implant. ..................................................................................... 26
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`a.
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`Figure 10 does not disclose the direct lateral
`insertion of an implant. ................................................... 27
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`i
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`b.
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`Brantigan uses the term “lateral” to mean lateral to
`the midline of the vertebral body. ................................... 29
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`2.
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`Brantigan does not disclose an implant with a length that
`occupies all or substantially all of the transverse width of
`adjacent vertebral bodies ........................................................... 31
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`a.
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`b.
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`c.
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`d.
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`Brantigan’s disclosure of the “shape and size” of
`plug 11 show it does not occupy substantially the
`full transverse width of adjacent vertebral bodies. ......... 32
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`Brantigan’s Figure 10 does not depict an implant
`of the claimed length. ..................................................... 35
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`Brantigan teaches that its implant can be rotated
`within the disc space. ...................................................... 37
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`The periphery of implant 11 is designed to sit on
`the center of the vertebral body. ..................................... 37
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`3.
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`Claim 24 - “the length of said implant being sized to
`occupy the full transverse width of the vertebral bodies of
`the two adjacent vertebrae” ....................................................... 38
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`4.
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`The parties’ prior litigation ....................................................... 39
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`D. Michelson ’247 .................................................................................... 40
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`1.
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`Figure 5 does not teach an implant that occupies the
`entire depth of a vertebral space. .............................................. 40
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`2. Michelson ’247 teaches an implant that should be
`recessed in the intervertebral space. ......................................... 42
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`3.
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`Claim 24 - “the length of said implant being sized to
`occupy the full transverse width of the vertebral bodies of
`the two adjacent vertebrae” ....................................................... 46
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`E.
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`F.
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`The Leu Reference .............................................................................. 47
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`The Claimed “Elongated Portion(s)” .................................................. 49
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`ii
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`VI. A PERSON OF ORDINARY SKILL IN THE ART WOULD NOT
`COMBINE THE REFERENCES AS SUGGESTED BY
`PETITIONER ................................................................................................ 50
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`A.
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`B.
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`Jacobson, Leu, and Brantigan ............................................................. 50
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`Jacobson, Leu, and Michelson ............................................................ 53
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`VII. SECONDARY INDICIA OF NON-OBVIOUSNESS .................................. 55
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`A.
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`B.
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`C.
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`D.
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`Teaching Away .................................................................................... 55
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`Commercial Success............................................................................ 56
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`Industry Praise ..................................................................................... 58
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`Copying ............................................................................................... 59
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`VIII. CONCLUSION .............................................................................................. 60
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`iii
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`TABLE OF AUTHORITIES
`
`
`Cases
`Asyst Techn., Inc. v. Emtrak, Inc.,
`544 F.3d 1310 (Fed. Cir. 2008) ............................................................................ 58
`
`August Tech. Corp. v. Camtek, Ltd.,
`655 F.3d 1278 (Fed. Cir. 2011) ............................................................................ 15
`
`Bettcher Indus., Inc. v. Bunzl USA, Inc.,
`661 F.3d 629 (Fed. Cir. 2011) .............................................................................. 25
`
`Broadcom Corp. v. Emulex Corp.,
`732 F.3d 1325 (Fed. Cir. 2013) ............................................................................ 14
`
`Cheese Sys., Inc. v. Tetra Pak Cheese and Powder Sys., Inc.,
`725 F.3d 1341 (Fed. Cir. 2013) ............................................................................ 14
`
`Crocs, Inc. v. Int’l Trade Comm’n,
`598 F.3d 1294 (Fed. Cir. 2010) ..................................................................... 57, 60
`
`Geo. M. Martin Co. v. Alliance Mach. Sys. Intern. LLC,
`618 F.3d 1294 (Fed. Cir. 2010) ............................................................................ 58
`
`Graybill v. U.S. Postal Serv.,
`782 F.2d 1567 (Fed. Cir. 1986) ............................................................................ 39
`
`In re Cortright,
`165 F.3d 1353 (Fed. Cir. 1999) ..................................................................... 10, 12
`
`Leo Pharm. Prods., Ltd. v. Rea,
`726 F.3d 1346 (Fed. Cir. 2013) ............................................................................ 55
`
`Luben Indus.v. United States,
`707 F.2d 1037 (9th Cir. 1983) .............................................................................. 40
`
`Merck & Co. v. Teva Pharma. USA, Inc.,
`395 F.3d 1364 (Fed. Cir. 2005) ............................................................................ 56
`
`Power Integrations, Inc. v. Fairchild Semi. Int’l, Inc.,
`763 F. Supp. 2d 671 (D. Del. 2010) ...................................................................... 40
`
`
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`iv
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`Rexnord Indus., LLC v. Kappos,
`705 F.3d 1347 (Fed. Cir. 2013) ..................................................................... 25, 26
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`Spectralytics, Inc. v. Cordis Corp.,
`649 F.3d 1336 (Fed. Cir. 2011) ..................................................................... 55, 56
`
`Transocean Offshore Deepwater Drilling, Inc. v. Maersk Drilling USA, Inc.,
`699 F.3d 1340 (Fed. Cir. 2012) ............................................................................ 60
`Statutes
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`35 U.S.C. § 316(e) ................................................................................................... 10
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`37 C.F.R. § 42.1(d) .................................................................................................. 10
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`37 C.F.R. § 42.100(b) .............................................................................................. 10
`Other Authorities
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`Manual of Patent Examining Procedure § 2111 ...................................................... 10
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`Manual of Patent Examining Procedure § 2112 ...................................................... 25
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`v
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`EXHIBITS
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`Exhibit No.
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`Description
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`WARSAW2001
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`Excerpts from Deposition of Dr. Michelson, dated November
`19, 2010
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`WARSAW2002
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`Letter to Dr. Michelson from J. Pafford, dated March 28, 1994.
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`WARSAW2003
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`Memorandum from Larry Boyd re: Michelson Devices -
`Interbody Fusion Devices, dated January 26, 1994
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`WARSAW2004
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`Dezider Imre Invoice, dated December 26, 1993
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`WARSAW2005
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`Memorandum from Larry Boyd re: Meeting with Dr. Gary
`Karlin Michelson, dated January 11, 1994
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`WARSAW2006
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`Memorandum from Larry Boyd re: Notes on Threaded Dowel
`Concepts of Dr. Michelson, dated January 11, 1994
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`WARSAW2007
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`Letter to Dr. Michelson from L. Boyd, dated January 13, 1994
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`WARSAW2008
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`Excerpts from Trial Testimony - Warsaw Orthopedic, Inc. v.
`NuVasive, Inc., Case No. 08-CV-1512 MMA (MDD)
`
`WARSAW2009
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`License Agreement between Sofamor Danek Group, Inc. and
`Karlin Technology, Inc., dated December 31, 1993
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`WARSAW2010
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`U.S. Patent No. 5,860,973
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`WARSAW2011
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`Memorandum of Decision Following Bench Trial on
`Inequitable Conduct, Warsaw Orthopedic, Inc. v. NuVasive,
`Inc., Case No. 08-CV-1512 MMA (MDD), dated February 14,
`2012
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`WARSAW2012
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`Excerpts from NuVasive’s Reply in Support of Its Renewed
`Motion for Judgment as a Matter of Law or A New Trial,
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`vi
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`WARSAW2013
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`WARSAW2014
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`WARSAW2015
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`Warsaw Orthopedic, Inc. v. NuVasive, Inc., Case No. 08-CV-
`1512 MMA (MDD), dated December 23, 2011
`
`Excerpts from NuVasive's Memorandum of Points and
`Authorities in Support of Its Renewed Motion for Judgment as
`a Matter of Law or a New Trial, Warsaw Orthopedic, Inc. v.
`NuVasive, Inc., Case No. 08-CV-1512 MMA (MDD), dated
`October 27, 2011
`
`Excerpts from NuVasive's Closing Argument Regarding
`Inequitable Conduct Committed During the Prosecution of the
`’973 Patent, Warsaw Orthopedic, Inc. v. NuVasive, Inc., Case
`No. 08-CV-1512 MMA (MDD), dated December 23, 2011
`
`Excerpts from NuVasive's Proposed Findings of Fact and
`Conclusions of Law Regarding the Unenforceability of U.S.
`Patent No. 5,860,973 for Inequitable Conduct, Warsaw
`Orthopedic, Inc. v. NuVasive, Inc., Case No. 08-CV-1512 MMA
`(MDD), dated December 23, 2011
`
`WARSAW2016
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`Letter to R. Jansen from P. McAfee, M.D., dated January 16,
`1995
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`WARSAW2017
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`Excerpts from Deposition of Dr. Bruce E. Van Dam, dated
`January 27, 2011
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`WARSAW2018
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`U.S. Patent No. 4,573,448
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`WARSAW2019
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`WARSAW2020
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`Excerpts from Deposition of L. Boyd, dated February 18, 1999
`from Sofamor Danek Holdings, Inc. v. U.S. Surgical Corp., Case
`No. 98-2369 GA (JSG) (W.D. Tenn.)
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`Excerpts from Deposition of L. Boyd, dated December 3, 2010
`from Warsaw Orthopedic, Inc. v. NuVasive, Inc., Case No. 08-
`CV-1512 MMA (MDD) (S.D. Cal.)
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`vii
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`WARSAW2021
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`WARSAW2022
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`WARSAW2023
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`WARSAW2024
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`WARSAW2025
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`WARSAW2026
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`WARSAW2027
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`Excerpts from Deposition of D. lmre, dated October 5, 2001
`from Medtronic Sofamor Danek, Inc. v. Osteotech, Inc., Case
`No. 99-2656-GN (W.D. Tenn.)
`
`Excerpts from Deposition of B. Estes, dated November 10,
`2003 from Medtronic Sofamor Danek, Inc. v. Karlin
`Technology, Inc., Case No. 01-2373-JPM (W.D. Tenn.)
`
`Excerpts from Deposition of G. Michelson, dated November
`19, 2010 from Warsaw Orthopedic, Inc. v. NuVasive, Inc., Case
`No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`
`Excerpts from Deposition of J. Pafford, dated April 3, 2003
`from Medtronic Sofamor Danek, Inc. v. Karlin Technology, Inc.,
`Case No. 01-2373-JPM (W.D. Tenn.)
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`Excerpts from Trial Testimony- Warsaw Orthopedic, Inc. v.
`NuVasive, Inc. , Case No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
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`Stipulation dated November 2, 2010 from Warsaw
`Orthopedic, Inc. v. NuVasive, Inc. , Case No. 08-CV-1512 MMA
`(MDD) (S.D. Cal.)
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`Excerpts from Deposition of L. Boyd, dated November 13,
`2003 from Medtronic Sofamor Danek, Inc. v. Karlin
`Technology, Inc. , Case No. 01-2373-JPM (W.D. Tenn.)
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`WARSAW2028
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`Excerpts from Trial Testimony- Warsaw Orthopedic, Inc. v.
`NuVasive, Inc. , Case No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
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`WARSAW2029
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`Ortho SuperSite entitled Migrated XLIF Cage: Case Report and
`Discussion of Surgical Technique, dated September 11, 2011
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`WARSAW2030
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`Declaration of Dr. Paul McAfee. M.D . M.B.A (206)
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`WARSAW2031
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`Declaration of Dr. Paul McAfee. M.D . M.B.A (208)
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`viii
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`WARSAW2032
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`U.S. Patent 8,251,997
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`WARSAW2033
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`Excerpts from Trial Testimony- Warsaw Orthopedic, Inc. v.
`NuVasive, Inc. , Case No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
`(with annotations)
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`WARSAW2034
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`U.S. Patent 5,015,247
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`WARSAW2035
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`Ortho SuperSite entitled Migrated XLIF Cage: Case Report and
`Discussion of Surgical Technique, dated September 11, 2011
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`WARSAW2036
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`Dr. McAfee’s Handwritten notes made during his deposition
`of December 7, 2013 and December 8, 2013
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`WARSAW2037
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`[RESERVED] This exhibit has not been filed with the Board
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`WARSAW2038
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`Declaration of Dr. Barton L. Sachs, M.D., M.B.A.
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`WARSAW2039
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`WARSAW2040
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`Excerpts from Deposition of Dr. Paul McAfee, dated
`December 6, 2013 and December 7, 2013 in matters IPR2013-
`00206 and IPR2013-00208
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`Dkt 613 ”Order Closing Case” from Warsaw Orthopedic, Inc. v.
`NuVasive, Inc., Case No. 08-CV-1512 MMA (MDD), dated
`August 20, 2011
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`WARSAW2041
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`Excerpts from Trial Testimony- Warsaw Orthopedic, Inc. v.
`NuVasive, Inc. , Case No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
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`WARSAW2042
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`U.S. Patent 4,834,757
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`WARSAW2043
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`Declaration of Mark Peterson M.D, dated January 19, 2011 in
`U.S. Court of Appeals, case No. 11-55120
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`WARSAW2044
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`Declaration of William D. Smith M.D, dated January 19, 2011
`in U.S. Court of Appeals, case No. 11-55120
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`ix
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`WARSAW2045
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`WARSAW2046
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`WARSAW2047
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`WARSAW2048
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`WARSAW2049
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`WARSAW2050
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`WARSAW2051
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`WARSAW2052
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`NuVasive’s Supplemental Responses to Interrogatory 11 -
`Warsaw Orthopedic, Inc. v. NuVasive, Inc. , Case No. 08-CV-
`1512 MMA (MDD) (S.D. Cal.)
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`Sales Data produced by NuVasive bearing Bates Nos.
`N0978712- N0979129- Warsaw Orthopedic, Inc. v. NuVasive,
`Inc. , Case No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
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`Sales Data produced by NuVasive bearing Bates Nos.
`N0980704- N0980720- Warsaw Orthopedic, Inc. v. NuVasive,
`Inc. , Case No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
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`Sales Data produced by Warsaw bearing Bates No.
`MNUV5009816- Warsaw Orthopedic, Inc. v. NuVasive, Inc. ,
`Case No. 08-CV-1512 MMA (MDD) (S.D. Cal.)
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`The XLIF Approach presentation produced by NuVasive
`bearing Bates Nos. N0017072 - N0017142- Warsaw
`Orthopedic, Inc. v. NuVasive, Inc. , Case No. 08-CV-1512 MMA
`(MDD) (S.D. Cal.)
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`Article titled “Direct Lateral Interbody Fusion -- A Minimally
`Invasive Approach to Spinal Stabilization” produced by
`Warsaw bearing Bates No. MNUV5059266 - MNUV5059271-
`Warsaw Orthopedic, Inc. v. NuVasive, Inc. , Case No. 08-CV-
`1512 MMA (MDD) (S.D. Cal.)
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`Article titled “A New Solution” produced by Warsaw bearing
`Bates No. MNUV5059287 - MNUV5059290- Warsaw
`Orthopedic, Inc. v. NuVasive, Inc. , Case No. 08-CV-1512 MMA
`(MDD) (S.D. Cal.)
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`Article titled “26 Technologies Receive 2009 Spine Technology
`Award” produced by Warsaw bearing Bates No. MNUV505991
`- Warsaw Orthopedic, Inc. v. NuVasive, Inc. , Case No. 08-CV-
`1512 MMA (MDD) (S.D. Cal.)
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`x
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`WARSAW2053
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`Article titled “Current Concepts Review -- Interbody Fusion
`Cages in Reconstructive Operations on the Spine”
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`WARSAW2054
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`Article titled “Spinal Implants: Past, Present, and Future”
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`WARSAW2055
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`Excerpt from book titled “Intervertebral Fusion -- Using
`Carbon Fiber Reinforced Polymer Implants”
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`WARSAW2056
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`Excerpts from Inequitable Conduct Trial Testimony- Warsaw
`Orthopedic, Inc. v. NuVasive, Inc. , Case No. 08-CV-1512 MMA
`(MDD) (S.D. Cal.)
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`xi
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`I.
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`INTRODUCTION
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`Dr. Gary Michelson’s invention of U.S. Patent No. 8,251,997 (the “’997
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`patent”) is directed to a method for intervertebral spinal fusion through the direct
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`lateral placement of a single implant across the entire or substantially the entire
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`transverse width of the intervertebral space. At the time, intervertebral spinal
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`fusion was achieved from largely anterior and posterior approaches, rather than
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`true lateral approaches. To be sure, the medical community was then aware of a
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`direct lateral approach to the spine, but the placement of an intervertebral
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`implant—much less one sized as claimed in the method of the ’997 patent—
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`through a minimally invasive direct lateral approach to promote interbody fusion
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`did not exist. Petitioner itself has submitted sworn declarations in federal court
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`that correctly describe the state of the prior art as devoid of direct lateral interbody
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`spinal fusion procedures. That state was not a function of spinal surgeons missing
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`the obvious. Surgeons—wed to the advantages of the prior art—simply did not
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`appreciate the tremendous clinical and biomechanical advantages presented by
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`Dr. Michelson’s method over that art (most prominently the ability to use a spinal
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`implant of unprecedented dimensions to achieve fusion). That method is now one
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`of the most popular means of achieving interbody spinal fusion and has achieved
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`tremendous clinical and commercial success.
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`Petitioner does not show by a preponderance of the evidence that the claims
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`1
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`

`

`
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`of the ’997 patent are rendered obvious by the grounds of unpatentability instituted
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`by the Board. The art on which the Board permitted review simply does not teach
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`what Petitioner purports it to teach. Most, if not all, of Petitioner’s arguments
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`about the prior art are predicated on the declaration of Dr. McAfee. In a deposition
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`taken in this proceeding, Dr. McAfee flatly contradicted his declaration and the
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`very statements on which the Board relied to institute review. Petitioner’s
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`allegedly invalidating prior art combinations are fundamentally flawed for
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`additional reasons. First, they fail to consider the state of all the relevant art at the
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`pertinent time. Second, they are afflicted by impermissible hindsight bias. Third,
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`they cannot withstand secondary indicia of non-obviousnes.
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`When Dr. Michelson first disclosed the method of the ’997 patent to Patent
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`Owner in the early 1990’s, individuals whose livelihood depended on ascertaining
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`and improving the state of interbody fusion surgery found Dr. Michelson’s method
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`to be distinct from, and advantageous over, the prior art now raised by Petitioner.
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`Indeed, Patent Owner decided to invest in it. Among the individuals evaluating
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`Dr. Michelson’s invention at that time was the Chief Executive Officer of the
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`Petitioner, who, after leaving the employ of the Patent Owner, built one of the
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`world’s largest spinal device companies around Dr. Michelson’s invention.
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`II. OVERVIEW OF U.S. PATENT NO. 8,251,997
`The ’997 patent was filed ultimately as a divisional of U.S. Patent No.
`
`
`
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`2
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`

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`5,772,661 (the “’661 patent”). The ’661 patent was filed on February 27, 1995 as
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`U.S. Patent Application No. 08/394,836. The specifications of the ’997 and ’661
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`patents are identical in all material respects. Moreover, as detailed in Warsaw’s
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`preliminary response in this proceeding, Dr. Michelson conceived and reduced to
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`practice the ’997 patented methods no later than December 26, 1993. Sachs Decl.
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`¶¶ 50-51; Exs. 2001 at 50:23–51:9, 54:3–11, 61:21–62:18; 2002; 2003; 2004.
`
`Summary of the ’997 Patent
`
`A.
`The ’997 patent is directed to methods of performing an interbody fusion
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`from a direct or “true” lateral approach with an implant that occupies either the full
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`or substantially the full transverse width of the vertebral bodies of two adjacent
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`vertebrae. Ex. 1002 at 1. These novel methods for interbody fusion provide for
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`optimal fill of the intervertebral space without endangering the delicate anatomical
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`structures surrounding the vertebral column. Id. at 3:18–30. As a result, the
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`claimed method permits use of an implant that provides stronger mechanical
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`support and, relatedly, improved fusion. Ex. 2038 (“Sachs Decl.”) ¶ 44.
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`Dr. Michelson explains in the ’997 patent that “the implant I of the present
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`invention inserted laterally provides for greater surface area of contact, the largest
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`volume of fusion promoting material, and the greatest mechanical engagement and
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`thus stability, and is therefore an improvement upon other methods of implant
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`insertion in facilitating a successful fusion.” Ex. 1002 at 21:33–38.
`
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`3
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`

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`
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`Advantages over prior art implants and methods
`
`1.
`As construed by the Board, the claimed implant must occupy either the full
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`transverse width of adjacent vertebral bodies or a length that is less than the full
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`transverse width of the vertebral bodies by an insubstantial amount. Decision at 9.
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`The same was not true of prior art implants. For example, the size and structure of
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`prior art interbody fusion implants were limited by the dural sac posteriorly and
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`delicate vital structures anteriorly, such as the vena cava and aorta. Ex. 1002 at
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`3:23–26. This is because prior art fusion implants were either inserted in an
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`anterior, posterior, or posterolateral approach to the spine. Id. at 2:37–52.
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`A prior art interbody fusion implant that is inserted posteriorly or anteriorly
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`necessarily has a length that is limited to the depth of the disc space, and is
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`preferably substantially shorter than that to avoid catastrophic injury to the delicate
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`and proximate dural sac and major vessels. Sachs Decl. ¶¶ 70, 112. Indeed,
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`Dr. Michelson teaches in his ’247 patent that an implant positioned in a posterior to
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`anterior direction is preferably “recessed” within the apophyseal ring that bounds
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`the endplate. Ex. 1008 at 10:31–36. Similarly, an implant that is inserted
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`obliquely (either posterolaterally or anterolaterally) cannot span the full or
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`substantially the full transverse width of adjacent vertebrae. Id. Prior art implants
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`inserted via a posterolateral approach—to the extent they can be called “implants”
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`at all—were even smaller because of anatomical constraints. Sachs Decl. ¶ 40.
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`4
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`For example, the transverse processes obstruct the surgical path such that only
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`narrow cannulae can be inserted in this approach and exiting nerve branches
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`leaving the vertebral foramen make the insertion of a large graft too dangerous. Id.
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`Dr. Michelson distinguishes these types of posterolateral fusion procedures in the
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`’997 patent: “The posterolateral approach has generally been utilized as a
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`compliment to percutaneous discectomy and has consisted of pushing tiny
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`fragments of morsalized bone down through a tube and into the disc space.”
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`Ex. 1002 at 2:49–52. The Leu reference discloses an example of posterolateral
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`interbody fusion through a narrow 7 mm cannula in which bone chips and a “graft
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`conglomerate” are impacted into the disc space. Ex. 1005 at 6, 10.
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`Dr. Michelson’s claimed implant
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`2.
`Dr. Michelson explains his concept of a direct lateral “coast-to-coast”
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`implant in the ’997 patent and distinguishes it from implants inserted obliquely:
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`It can be seen from Fig. 30 that the implant I has a true lateral
`orientation with respect to the vertebra L4, such that there is a great
`area of contact between the implant I and the vertebra L4. Referring
`to Figure 30A, a top sectional view of a vertebra similar to Fig. 30 is
`shown illustrating the area of contact of the implant I and the
`vertebrae L4 when the implant I is inserted with the “Lateral Method”
`of the present invention from a slightly anterior position
`(anterolateral) along the Lateral aspect of the spine and in an at least
`partially side to side direction.
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`5
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`Ex. 1002 at 20:31–41, Figs. 30, 30A (annotated to illustrate unoccupied space).
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`
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`Thus, even a slightly oblique approach results in a decrease in the area that is
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`occupied by the implant, which reduces the potential area of fusion between
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`adjacent vertebral bodies. This effect is magnified when the angle of the approach
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`becomes more posterior or anterior. In addition to the length requirement
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`mentioned above, the claims of the ’997 recite an implant with a length—from the
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`implant’s insertion to trailing end—that is greater than the depth of the disc space.
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`Id. at 23:29–30. Implants designed for anterior and posterior insertion cannot meet
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`or disclose this limitation. Sachs Decl. ¶¶ 70, 122. Moreover, these prior art
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`implants teach away from the dimensions of the claimed implant because the
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`anterior great vessels and posterior spinal nerves required the implants to be
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`positioned well away from the edges of the vertebral bodies. Id. ¶¶ 112, 117.
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`The implants of the claimed methods are sized to rest on the apophyseal
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`ring, which is an area of dense, avascular bone between the vertebral endplate (to
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`the center) and the cortical rim (the edge of the vertebral body). Id. ¶¶ 29, 65.
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`Seating an implant on the apophyseal ring provides enhanced biomechanical
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`stability because the implant is less likely to subside into the soft cancellous bone
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`in the center of the vertebral body. Id. ¶¶ 29, 44. While fusion is unlikely to occur
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`6
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`at the apophyseal ring due to the low vascularity of the area (blood flow is critical
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`to a successful fusion), the mechanical stability of the implant provides structural
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`support and stability to allow fusion between vertebral bodies to occur.1 Id. ¶ 29.
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`Dr. Michelson’s “true” lateral method
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`3.
`The insertion of this implant is accomplished by a specific sequence of steps
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`that require the insertion of at least three surgical instruments into the body of a
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`patient, with the claimed implant being inserted through the third surgical
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`instrument. First, all claims of the ’997 patent recite “making an incision in skin of
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`a patient’s body . . . proximate an intersection of the skin and a path having an axis
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`lying in a coronal plane passing through a lateral aspect and a medial aspect of the
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`
`
`1 Dr. McAfee opines that the examiner’s rejections in the reissue proceedings of
`the ’661 patent establishes the implant of the ’997 method cannot rest on the
`apophyseal ring. Ex. 1001 ¶ 19. But the language rejected by the examiner in that
`proceeding related to the implant contacting the “cortical rim”—i.e., the very edge
`of the vertebral body. The cortical or apophyseal rim is distinct from the
`apophyseal ring. Sachs Decl. ¶ 29. Moreover, there is sufficient support in the
`specification for an implant that spans the full transverse width of adjacent
`vertebral bodies. See, e.g., Ex. 1002 at 11:3–8. Petitioner’s attempt to limit the
`scope of the claims to the figures is contrary to Federal Circuit precedent and an
`improper ¶112 argument. Arlington Indus., Inc. v. Bridgeport Fittings, Inc., 632
`F.3d 1246, 1254 (Fed. Cir. 2011) (“drawings in a patent need not illustrate the full
`scope of the invention”); MBO Labs., Inc. v. Becton, Dickinson & Co., 474 F.3d
`1323, 1333 (Fed. Cir. 2007).
`
`
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`7
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`two adjacent vertebrae and anterior to the transverse processes.” Ex. 1002 at
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`22:48–63. As explained below, a “path having an axis lying in a coronal plane”
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`defines a direct or true lateral path to the spine. Id. at 22:60–61. Through this
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`incision, the claims recite “advancing a first surgical instrument having a length
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`into the body of the patient through said incision until proximate the disc space
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`along said path and anterior to the transverse processes.” Id. at 22:64–67. A
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`second surgical instrument is then advanced over at least a portion of the length of
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`the first surgical instrument. Id. at 23:1–8. A third surgical instrument is then
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`advanced over at least a portion of the second surgical instrument and positioned
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`“such that said distal end of said third surgical instrument is proximate a lateral
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`aspect of the vertebral bodies of the two adjacent vertebrae.” Id. at 23:9–18. The
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`claimed implant is inserted through the third surgical instrument. Id. at 23:19–39.
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`III. BOARD’S DECISION TO INSTITUTE REVIEW
`The Board has instituted inter partes review (“IPR”) with respect to the
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`following grounds of unpatentability in the Petition that include U.S. Patent No.
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`4,545,374 (“Jacobson”); Leu et al., “Percutaneous fusion of the lumbar spine,”
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`SPINE: State of the Art Reviews, Vol. 6, No. 3, Sep. 1992 (“Leu”); U.S. Patent
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`No. 5,192,327 (“Brantigan”); U.S. Patent No. 5,015,247 (“Michelson ’247”);
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`European Patent Application No. 0 567 424 A1 to Alacreu (“Alacreu”); and U.S.
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`Patent No. 4,917,704 (“Frey”).
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`
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`8
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`Reference(s)
`Jacobson, Leu, Brantigan
`Jacobson, Leu, Michelson ’247
`Jacobson, Leu, Brantigan, and Frey
`Jacobson, Leu, Michelson ’247, and Alacreu
`
`
`
`
`Basis
`§103
`§103
`§103
`§103
`
`Claims Being Reviewed
`1 and 8
`1 and 8
`2–7
`2–7
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`Every ground of unpatentability is premised on the combination of Jacobson,
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`Leu, and Brantigan or Michelson to show: (a) insertion of an implant across all or
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`substantially all of the transverse width of the intervertebral space, (b) via a direct
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`lateral path to the spine, (c) using sequential dilation. In instituting review, the
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`Board specifically relied upon extrinsic evidence submitted by Petitioner in the
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`form of a declaration from Dr. Paul McAfee that (i) “a ‘fusion’ procedure
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`‘necessarily includes the insertion of an implant into the disc space;’”
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`(ii) “Michelson ’247 further suggests that an implant ‘should extend longitudinally
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`across the full disc space along the direction of insertion;’” and (iii) “‘Brantigan’s
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`Figure 10 shows implants 53 and 54 that have been inserted laterally into the disc
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`space’ and that ‘a person of ordinary skill in the art would have been prompted . . .
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`to employ an implant structure . . . so that the implant extends longitudinally across
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`nearly the full disc space.’” Decision at 11, 13, 17.
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`As discussed below, however, in a deposition taken in this proceeding,
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`Dr. McAfee flatly contradicted or materially undermined each of these statements
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`in his declaration on which the Board relied in instituting review. Moreover,
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`Patent Owner, relying on the detail of the prior art ignored by Petitioner and the
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`declaration of Dr. Barton Sachs, affirmatively establishes not only that the prior art
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`fails to disclose what Petitioner claims it does, but that combining the art as
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`proposed by the Petitioner would be inappropriate and fail to yield the claimed
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`inventions. For these and other reasons explained below, Petitioner cannot carry
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`its “burden of proving a proposition of unpatentability by a preponderance of the
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`evidence.” 35 U.S.C. § 316(e); 37 C.F.R. § 42.1(d).
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`IV. CLAIM CONSTRUCTION
`The Board interprets claim terms by applying the broadest reasonable
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`construction in the context of the specification in which the claims reside.
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`37 C.F.R. § 42.100(b). However, the broadest reasonable construction of a claim
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`term “must [also] be consistent with the [interpretation] that those skilled in the art
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`would reach.” In re Cortright, 165 F.3d 1353, 1358 (Fed. Cir. 1999); Manual of
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`Patent Examining Procedure (“MPEP”) § 2111.
`
`A.
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`“a path having an axis lying in a coronal plane passing through a
`lateral aspect and a medial aspect of the two adjacent vertebrae
`and anterior to the transverse processes”
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`The specification of the ’997 patent describes two novel approaches to the
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`spine for an interbody fusion surgery: a “true” lateral approach and an
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`anterolateral approach. Ex. 1002 at 3:34–39.