Case IPR2013-00396
`U.S. Patent No. 8,444,696
`Our Ref. 101.0051-06IR2
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`Patent Owner Response
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`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: 8,444,696
`Issue Date: May 21, 2013
`ANATOMIC SPINAL IMPLANT HAVING
`ANATOMIC BEARING SURFACES
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`________________
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`Case IPR2013-00396
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`___________________________________________________
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`WARSAW’S PATENT OWNER RESPONSE
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`U.S. Patent No. 8,444,696
`Our Ref. 101.0051-06IR2
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`
`
`
`Patent Owner Response
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`________________
`
`NUVASIVE, INC.
`Petitioner
`
`v.
`
`WARSAW ORTHOPEDIC, INC.
`Patent Owner
`
`
`Patent Number: 8,444,696
`Issue Date: May 21, 2013
`ANATOMIC SPINAL IMPLANT HAVING
`ANATOMIC BEARING SURFACES
`
`________________
`
`
`Case IPR2013-00396
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`___________________________________________________
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`WARSAW’S PATENT OWNER RESPONSE
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`TABLE OF CONTENTS
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`I.
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`II.
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`INTRODUCTION. .......................................................................................... 1
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`BACKGROUND. ............................................................................................ 4
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`A. Prosecution of the ‘696 patent. .................................................................. 4
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`B. Spinal fusion implants. ............................................................................... 4
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`C. Summary of the ‘696 patent. ...................................................................... 4
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`D. Michelson ‘037, like Steffee and Kim, was of record during the
`prosecution of the ‘696 patent. .................................................................. 9
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`E. The rejections presented in the inter partes reexamination of the ‘430
`patent are not germane because claims 7-12 of the ‘696 patent are
`substantially narrower than those of the ‘430 patent. ............................. 10
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`F. During prosecution of the ‘998 application resulting in the ‘696 patent,
`the Examiner made a thorough review of the art references of record,
`and allowed claims 7-12 over these art references. ................................ 11
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`III. OBJECTION TO THE INCLUSION OF DRAWINGS IN THE
`CORRECTED PETITION ‘396 THAT ARE NOT CLEARLY MARKED
`AS BEING MODIFIED FIGURES OF THE CITED REFERENCES. ....... 13
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`IV.
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`INDEPENDENT CLAIMS 7 AND 10 ARE PATENTABLE OVER THE
`REJECTION BASED ON THE ASSERTED COMBINATION OF
`STEFFEE, MICHELSON ‘037, AND KIM.................................................. 14
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`A. Claim construction of independent claims 7 and 10. .............................. 14
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`B. Standard of nonobviousness under 35 U.S.C. § 103(a). .......................... 19
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`C. Statements regarding “obvious choices,” “add-ons,” or “basic
`design choices.” ....................................................................................... 22
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`D. Independent claims 7 and 10 are patentable over the asserted
`combination of Steffee, Michelson ‘037, and Kim. ................................ 23
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`V.
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`CONCLUSION. ............................................................................................. 47
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`Cases
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`TABLE OF AUTHORITIES
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`Application of Sporck, 301 F.2d 686 (C.C.P.A. 1962) ........................................... 22
`CFMT, Inc. v. YieldUp Int’l. Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003) .......... 20
`Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966) ............................... 19
`In re Gurley, 27 F.3d 551, 553 (Fed. Cir. 1994) ...................................................... 21
`In re Icon Health & Fitness, Inc., 496 F.3d 1374, 1381 (Fed. Cir. 2007) ............... 21
`In re Kahn, 441 F.3d 977, 988 (Fed. Cir. 2006) ...................................................... 19
`In re Ochiai, 71 F.3d 1565, 1572 (Fed. Cir. 1995) .................................................. 20
`In re Royka, 490 F.2d 981, 985 (C.C.P.A. 1974) .................................................... 20
`In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007) ........................ 14
`KSR v. Teleflex, 550 U.S. 398 (2007) ........................................................ 19, 20, 21
`Monroe Auto Equipment Co. v. Heckethorn Mfg. & Supply Co., 332 F.2d 406 (6th
`Cir. 1964) ....................................................................................................... 21, 22
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`Statutes
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`35 U.S.C. § 102 .......................................................................................................... 2
`35 U.S.C. § 103(a) ............................................................ 2, 3, 19, 20, 21, 22, 46, 47
`35 U.S.C. § 120 .......................................................................................................... 4
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`Regulations
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`37 C.F.R. § 1.56 ....................................................................................................... 12
`37 C.F.R. § 1.97(d) .................................................................................................. 12
`37 C.F.R. § 42.100(b) .............................................................................................. 14
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`37 C.F.R. § 42.120 ..................................................................................................... 1
`37 CPR. § 42.120 ..................................................................................................... 1
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`EXHIBITS
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`WARSAW2001 Affidavit of Mr. Luke Dauchot.
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`WARSAW2002 Affidavit of Mrs. Nimalka Wickramasekera.
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`WARSAW2003 U.S. Patent No. 4,834,757 to Brantigan
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`WARSAW2004 U.S. Patent No. 5,425,772 to Brantigan
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`WARSAW2005 Declaration of Dr. Charles L. Branch, Jr., M.D.
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`WARSAW2006 Curriculum vitae of Dr. Charles L. Branch, Jr., M.D.
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`WARSAW2007 Comparison of claim 7 of the ‘696 patent and claim 19 of the
`‘430 patent.
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`WARSAW2008 Comparison of claim 10 of the ‘696 patent and claim 26 of the
`‘430 patent.
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`WARSAW2009 Deposition transcript of Dr. John W. Brantigan, M.D. taken
`April 7, 2014.
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`I.
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`INTRODUCTION.
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`In accordance with 37 C.F.R. § 42.120, Patent Owner, Warsaw Orthopedic,
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`Inc. (“Warsaw”), submits the present Response to the Decision of the Patent Trial
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`and Appeal Board of December 20, 2013 (“Board Decision”) and the July 9, 2013
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`Corrected Petition for Inter Partes Review (“Corr. Petition ‘396”), filed by the
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`Petitioner, NuVasive, Inc. (“NuVasive”). The Corr. Petition ‘396 is directed to
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`claims 7-12 (including independent claims 7 and 10) of U.S. Patent No. 8,444,696
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`(“’696 patent”).
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`The Corr. Petition ‘396 directed to claims 7-12 is one of two petitions filed
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`by NuVasive directed to the ‘696 patent; the other such petition is directed to
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`claims 1-6 of the ‘696 patent.
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`In the Corr. Petition ‘396, NuVasive asserted the following proposed
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`rejections of claims 7-12:
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`1. Claims 7-8 and 10-12 (including independent claims 7 and 10) of the ‘696
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`patent are allegedly obvious under 35 U.S.C. § 103(a) based on U.S. Patent
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`No. 5,607,424 to Tropiano (“Tropiano”) in view of U.S. Patent No. 5,015,247
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`to Michelson (“Michelson ‘247”) and PCT Publication No. WO 89/09035 to
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`Brantigan (“Brantigan ‘035”).
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`2. Claims 9 and 12 of the ‘696 patent are allegedly obvious under 35 U.S.C.
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`§ 103(a) based on Tropiano in view of Brantigan ‘035 and PCT Publication
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`No. WO 95/008306 to Beckers et al. (“Beckers”).
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`3. Claims 7-12 (including independent claims 7 and 10) of the ‘696 patent are
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`allegedly obvious under 35 U.S.C. § 103(a) based on Beckers in view of
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`Michelson ‘247 and Brantigan ‘035.
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`4. Claims 7-12 of the ‘696 patent (including independent claims 7 and 10) are
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`allegedly obvious under 35 U.S.C. § 103(a) based on U.S. Patent No. 5,443,514
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`to Steffee (“Steffee”) in view of Michelson ‘037 and U.S. Patent No. 5,645,596
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`to Kim et al. (“Kim”).
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`Patent Owner notes that the Corr. Petition ‘396 did not assert that claims
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`7-12 of the ‘696 patent are anticipated by any of the cited prior art references under
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`35 U.S.C. § 102. Instead, NuVasive pieced together several multiple-reference
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`combinations in the Corr. Petition ‘396 to argue that claims 7-12 of the ‘696 patent
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`are invalid as obvious under 35 U.S.C. § 103(a). Furthermore, Patent Owner notes
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`that in Dr. Brantigan’s ‘396 Declaration it is indicated with reference to the ‘696
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`patent that “[i]mplants of this type were invented at least as early as the early
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`1980's, and provide structural stability while bone grows between the adjacent
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`vertebrae to fuse them together.” (‘396 Brantigan Dec. (Ex. 1101) ¶ 7.) In
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`response, it is noted that none of the references cited by NuVasive in the Board’s
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`preliminarily adopted rejections include such an early 1980’s priority date, nor
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`show all of the features recited by claims 1-6.
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`This Response addresses the ground for unpatentability of the ‘696 patent
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`raised by NuVasive not already denied in the Board Decision, i.e., the rejection of
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`claims 7-12 under 35 U.S.C. § 103(a) based on the asserted combination of Steffee,
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`Michelson ‘037, and Kim. As discussed below, Warsaw submits that claims 7-12
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`are patentable over the preliminarily adopted rejection under 35 U.S.C. § 103(a)
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`based on the asserted combination of Steffee, Michelson ‘037, and Kim for at least
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`the following reasons:
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`● If Steffee, Michelson ‘037, and Kim were combined in the manner proposed by
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`NuVasive, which Warsaw at the very least denies one of ordinary skill would
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`propose, the asserted combination does not result in each and every limitation
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`of independent claims 7 and 10;
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`● One of ordinary skill would not combine these references by modifying the
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`spacer implant 10 of Steffee to include the features of Michelson ‘037 and Kim
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`as asserted by NuVasive because many of the teachings of Steffee, Michelson
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`‘037, and Kim diverge from one another, and in certain instances, these
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`references teach away from one another and NuVasive’s asserted combination
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`thereof; and
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`● Contrary to the applicable precedent, a hindsight-driven analysis was relied
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`upon to arrive at the asserted combination of Steffee, Michelson ‘037, and Kim.
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`II. BACKGROUND.
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`A. Prosecution of the ‘696 patent.
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`The ‘696 patent, entitled, “Anatomic Spinal Implant Having Anatomic
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`Bearing Surfaces,” issued to Dr. Gary K. Michelson on May 21, 2013 from U.S.
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`Serial No. 13/235,998 (“‘998 application”), filed on September 19, 2011. The ‘998
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`application was filed as a continuation under 35 U.S.C. § 120 of U.S. Application
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`No. 12/807,489, issued as U.S. Patent No. 8,021,430 (“‘430 patent”). The ‘696
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`patent ultimately claims priority, via a series of continuation/divisional
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`applications under 35 U.S.C. § 120 to U.S. Application No. 08/482,146, issued as
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`U.S. Patent No. 5,609,635, filed on June 7, 1995. Accordingly, the claims of the
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`‘696 patent are entitled to an effective filing date of June 7, 1995.
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`B. Spinal fusion implants.
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`As commonly understood, a spinal fusion implant participates in bony fusion
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`of adjacent vertebrae via bone growth between the adjacent vertebrae into and
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`through the spinal fusion implant. (Dec. of Dr. Charles L. Branch (Ex. 2005)
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`¶ 24.) The ‘696 patent is directed to spinal fusion implants.
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`C. Summary of the ‘696 patent.
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`The ‘696 patent is directed to “spinal fusion implants configured to restore
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`and maintain two adjacent vertebrae of the spine in correct anatomical angular
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`relationship.” (‘696 patent 1:21-23.) According to the ‘696 patent, “[t]he present
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`invention is directed to interbody spinal fusion implants having a structural
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`configuration that provides for the maintaining and creating of the normal
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`anatomic angular relationship of two adjacent vertebrae of the spine to maintain
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`and create spinal lordosis.” (‘696 patent 1:57-61.) Furthermore, “[t]he spinal
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`fusion implants of the present invention are sized to fit within the disc space
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`created by the removal of disc material between two adjacent vertebrae and
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`conform wholly or in part to the disc space created.” (‘696 patent 1:61-64.) As
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`such, objects of the ‘696 patent include providing “a spinal fusion implant that fits
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`between [two] adjacent vertebrae and preserves the end [plates] of those
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`vertebrae,” and “a spinal fusion implant having a shape which conforms to the
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`endplates of the adjacent vertebrae.” (‘696 patent 4:27-31.)
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`1. Features of the spinal fusion implants disclosed in the ‘696 patent.
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`To facilitate spinal fusion, while simultaneously maintaining and creating
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`the normal anatomic angular relationship of the adjacent vertebrae, and preserving
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`the anatomic endplates of the adjacent vertebrae, the spinal fusion implants
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`disclosed in the ‘696 patent include certain features. These certain features include
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`the following:
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`1. The spinal fusion implants of the ‘696 patent can include upper and lower
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`bearing surfaces that are convexly curved to conform to the anatomic endplates of
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`the adjacent vertebrae. The ‘696 patent indicates that the spinal fusion implants of
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`the ‘696 patent “are sized to fit within the disc space created by the removal of disc
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`material between two adjacent vertebrae and conform wholly or in part to the disc
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`space created.” (‘696 patent 1:62-64.) According to the ‘696 patent, “[t]he spinal
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`fusion implants of the present invention have upper and lower surfaces that form a
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`support structure for bearing against the [endplates] of the adjacent vertebrae.”
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`(‘696 patent 1:65-67.) Furthermore, the ‘696 patent indicates that “[t]he implants
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`of the present invention have various faces which may be curved so as to conform
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`to the shape of the vertebral surfaces adjacent to the area of the disc removal.”
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`(‘696 patent 2:23-25.) To provide such a conforming support structure, the ‘696
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`patent indicates that “the upper and/or lower surfaces may be convex.” (‘696
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`patent 2:26.) To illustrate, “[t]he implant 300 conforms to the endplates of the
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`adjacent vertebrae V1 and V2 as the upper and lower surfaces 312 and 314 are
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`convex.” (‘696 patent 9:37-39.)
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`2. The spinal fusion implants of the ‘696 patent can include openings
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`therethrough that afford the occurrence of bone growth between the adjacent
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`vertebrae into and through the spinal fusion implants. To illustrate, the spinal
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`fusion implant 200 depicted in Figs. 8-12 of the ‘696 patent includes a plurality of
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`channels (or openings) 215 that pass “from the upper surface 212 to the lower
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`surface 214 through the implant 200.” (‘696 patent 8:7-8.) According to the ‘696
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`patent, “[t]he channels 215 provide for bone ingrowth and facilitate the
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`incorporation of the implant 200 into the spinal fusion mass.” (‘696 patent 8:8-10.)
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`3. The spinal fusion implants of the ‘696 patent can include ratchetings
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`provided on the upper and lower bearing surfaces that include facets that are
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`angled to afford forward movement of the spinal fusion implant in one direction
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`and facets that are angled to prevent the spinal fusion implant from backing out in
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`the opposite direction. According to the ‘696 patent, the ratchetings are oriented to
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`afford “one-way insertion” of the spinal fusion implants between the adjacent
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`vertebrae. (‘696 patent 8:43-46.) Furthermore, once inserted therebetween, the
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`ratchetings prevent the spinal fusion implants from backing out from between the
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`adjacent vertebrae. (‘696 patent 8:46-47.) To illustrate, the implant 200 depicted
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`in Figs. 8-12 of the ‘696 patent includes a plurality of ratchetings 250. The ‘696
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`patent indicates that “[t]he ratchetings 250 comprise a bone engaging edge 252 and
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`angled segment 254.” (‘696 patent 8:38-39.) According to the ‘696 patent, “[t]he
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`plurality of ratchetings 250 are oriented in the direction of the insertion end 220 to
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`provide for a one-way insertion of the implant 200 as the bone engaging edge 252,
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`or ridge, engages the vertebrae and prevents the implant from backing out once
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`implanted.” (‘696 patent 8:42-47.)
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`2. Unnecessarily narrow reading of the ‘696 patent by NuVasive’s
`expert.
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`Warsaw notes that Dr. Brantigan asserts that “the '696 patent discloses an
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`assortment of isolated embodiments of spinal fusion implants, which in some
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`cases, are mutually exclusive to one another both in terms of structure and
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`implantation techniques.” (‘396 Bratigan Dec. (Ex. 1101) ¶ 7.) In response,
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`Warsaw is unclear what Dr. Brantigan means by “isolated embodiments,” but it is
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`noted that many of the features of the embodiments of the ‘696 patent are not
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`exclusive to a particular embodiment.
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`Furthermore, Warsaw notes that Dr. Brantigan asserts that “[t]he stated main
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`difference between earlier spinal fusion implants (such as Dr. Michelson's earlier
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`1988 patent application family published as the Michelson ‘037 reference) and the
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`'696 patent is the disclosure in the latter of implants having a well-known ‘lordotic’
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`design, meaning they have a ‘wedge shape’ in an elevation side view.” (‘396
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`Brantigan Dec. (Ex. 1101) ¶ 8.) In response, Patent Owner submits that Dr.
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`Brantigan is reading the ‘696 patent too narrowly with respect to the disclosure
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`thereof. To illustrate, Patent Owner submits that the spinal fusion implants
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`disclosed in the ‘696 patent are not limited to those that are wedge shaped.
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`D. Michelson ‘037, like Steffee and Kim, was of record during the
`prosecution of the ‘696 patent.
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`NuVasive indicates that Steffee and Kim were of record during the
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`prosecution of the ‘696 patent, but asserts that Michelson ‘037 was not of record.
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`(Corr. Petition ‘396 3:4-6.) Warsaw submits that NuVasive’s assertion regarding
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`Michelson ‘037 is technically, but not effectively, accurate. An equivalent
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`counterpart of Michelson ‘037 was of record during the original prosecution of the
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`‘696 patent.
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`Michelson ‘037 is a PCT Publication that claims priority to U.S. Application
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`No. 07/212,480, and U.S. Application No. 07/212,480 is a parent of U.S. Patent
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`No. 5,522,899 to Michelson. U.S. Patent No. 5,522,899 claims priority to U.S.
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`Application No. 07/212,480 as a continuation. Furthermore, Michelson ‘037 and
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`U.S. Patent No. 5,522,899 share almost entirely identical specifications. Because
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`U.S. Patent No. 5,522,899 was of record during the original prosecution thereof, an
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`equivalent counterpart to Michelson ‘037 was of record during the original
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`prosecution of the ‘696 patent. Thus, Steffee, Michelson ‘037, and Kim were all
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`effectively of record during the prosecution of the ‘696 patent.
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`E. The rejections presented in the inter partes reexamination of the
`‘430 patent are not germane because claims 7-12 of the ‘696 patent
`are substantially narrower than those of the ‘430 patent.
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`The ‘696 patent is a continuation of the ‘430 patent, and the ‘430 patent was
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`the subject of an inter partes reexamination, i.e., Control No. 95/002,3801 (“’380
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`reexamination”). Independent claims 7 and 10 of the ‘696 patent are substantially
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`different from the independent claims of the ‘430 patent – independent claims 7
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`and 10 of the ‘696 patent are substantially narrower. To illustrate, Ex. 2007 details
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`a comparison between claim 7 of the ‘696 patent and claim 19 of the ‘430 patent,
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`and Ex. 2008 details a comparison between claim 10 of the ‘696 patent and claim
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`26 of the ‘430 patent. Underlined portions of Ex. 2007 and Ex. 2008 denote
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`additional recitations included in claims 7 and 10 of the ‘696 patent, respectively.
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`NuVasive discusses the rejections presented in the Request for Inter Partes
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`Reexamination in the ‘380 reexamination at p. 6, ll. 1-9, of the Corr. Petition ‘396.
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`However, given the substantial differences therebetween, Warsaw submits that the
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`rejections presented in the ‘380 reexamination directed to claims of the ‘430 patent
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`are not germane to the patentability of claims 7-12 of the ‘696 patent.
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`1 A reexamination certificate issued August 26, 2013 in the ‘380 reexamination.
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`F. During prosecution of the ‘998 application resulting in the ‘696
`patent, the Examiner made a thorough review of the art references
`of record, and allowed claims 7-12 over these art references.
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`The claims of the ‘430 patent were amended to include the subject matter of
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`Figs. 31 and 32 during the ‘380 reexamination. However, rather than properly
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`challenging the amended claims of the ‘430 patent during the ‘380 reexamination,
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`NuVasive improperly submitted a 48-page document (“NuVasive’s improper
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`document”) on March 21, 2013 including proposed rejections of independent
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`claims 26 and 292 being prosecuted in the ‘998 application. That is, instead of
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`properly commenting on the amended claims of the ‘430 patent during the ‘380
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`reexamination, NuVasive improperly commented on independent claims 26 and 29
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`in the ‘998 application. In doing so, NuVasive violated USPTO practice and
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`injected itself into the prosecution of the ‘998 application. NuVasive’s improper
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`document was expunged3 from the ‘380 reexamination.
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`2 Independent claims 26 and 29 of the ‘998 application correspond to claims 7 and
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`10 of the ‘696 patent.
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`3 NuVasive’s improper document was expunged from the ‘380 reexamination by a
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`Decision Expunging/Returning Papers in Reexamination dated March 26, 2013 in
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`the ‘380 reexamination.
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`Nevertheless, given that NuVasive’s improper document included proposed
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`rejections of independent claims 26 and 29 being prosecuted therein, Warsaw
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`submitted this document in an Information Disclosure Statement of April 5, 2013
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`(“April 2013 IDS”) in the ‘998 application. NuVasive’s improper document was
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`submitted after the Notice of Allowance under 37 C.F.R. § 1.97(d) in the ‘998
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`application in satisfaction of 37 C.F.R. § 1.56. NuVasive used the requirements of
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`37 C.F.R. § 1.56 (and the certainty that Warsaw would follow these requirements)
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`to effectively force submission of the improper document in the ‘998 application.
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`However, in light of the submission of NuVasive’s improper document in
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`the April 2013 IDS, the proposed rejections of independent claims 26 and 29
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`(corresponding to independent claims 7 and 10, respectively, of the ‘696 patent)
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`were considered4 by the Examiner during the prosecution of the ‘998 application.
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`The Examiner did not deem the proposed rejections material to the patentability of
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`independent claims 26 and 29 of the ‘998 application. In the Office
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`Communication of April 30, 2013, the Examiner indicated the following:
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`After a careful review of the IDS filed on April 05, 2013, the
`reexamination case serial number 95/002,380 and all the references
`cited in the reexamination, the Examiner has not been able to find a
`reference that can be used as a 102 or 103 rejections. The Examiner
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`4 See Office Communications dated April 19, 2013 and April 30, 2013.
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`believes that any combinations of references cited in this application
`(e.g. IDS's or references cited by the Examiner) will be based upon
`improper hindsight reasoning. The Examiner wants to point out that
`the Applicant's representative has added new limitations in the
`amendment filed on February 25, 2013, therefore, those limitations
`make the claims allowable.
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`As such, the Examiner indicated that independent claims 26 and 29 of the ‘998
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`application (corresponding to independent claims 7 and 10, respectively, of the
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`‘696 patent) were patentable over the rejections proposed in NuVasive’s improper
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`document, and the Examiner affirmed that independent claims 26 and 29 of the
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`‘998 application were patentable over the art references of record including all of
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`the references or their effective equivalents cited in the Corr. Petition ‘396.
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`III. OBJECTION TO THE INCLUSION OF DRAWINGS IN THE
`CORRECTED PETITION ‘396 THAT ARE NOT CLEARLY
`MARKED AS BEING MODIFIED FIGURES OF THE CITED
`REFERENCES.
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`The Corr. Petition ‘396 includes both drawings that are copied from the
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`figures of the cited references, and drawings that are modified versions of the
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`figures of the cited references. However, Warsaw submits that many of the
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`modified versions of the figures are not clearly marked as being such. Thus, to
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`avoid confusion, it is respectfully requested that the Board take special care in
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`reviewing the Corr. Petition ‘396 to avoid any confusion regarding the origin of the
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`- 13 -
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`drawings contained therein. Moreover, if a reply to the present Response is filed, it
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`is also requested that NuVasive clearly mark the drawings contained therein.
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`IV.
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`INDEPENDENT CLAIMS 7 AND 10 ARE PATENTABLE OVER THE
`REJECTION BASED ON THE ASSERTED COMBINATION OF
`STEFFEE, MICHELSON ‘037, AND KIM.
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`A. Claim construction of independent claims 7 and 10.
`In an inter partes review, claim terms of an unexpired patent are given their
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`broadest reasonable construction in light of the specification of the patent in which
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`they appear. (37 C.F.R. § 42.100(b).) Furthermore, under the broadest reasonable
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`interpretation standard, claims are given their ordinary and customary meaning in
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`view of the specification as would be understood by one of ordinary skill in the art
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`(“one of ordinary skill”) at the time of the invention. (In re Translogic Tech., Inc.,
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`504 F.3d 1249, 1257 (Fed. Cir. 2007).)
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`1. Meaning of the claim recitation “opening.”
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`Independent claims 7 and 10 each recite “an opening between said trailing
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`face and said insertion face and between said first and second sides to permit for
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`the growth of bone through said implant from the first vertebra to the second
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`vertebra.”
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`As discussed above, the openings disclosed in the ‘696 patent are used to
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`afford the occurrence of bone growth between the adjacent vertebrae into and
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`through the spinal fusion implant.
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`- 14 -
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`As understood by one of ordinary skill, the ordinary and customary meaning
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`of the claim term “opening” in light of the specification and drawings of the ‘696
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`patent is a hole through the spinal fusion implant. (Ex. 2005 ¶ 33.) Thus, one of
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`ordinary skill would understand the recitation of “opening” of independent claims
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`7 and 10 in light of the specification and drawings of the ‘696 patent to be a hole
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`through the spinal fusion implant further limited in two ways. (Ex. 2005 ¶ 33.)
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`First, the hole is located “between said trailing face and said insertion face and
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`between said first and second sides,” and second, the hole permits “the growth of
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`bone through said implant from the first vertebra to the second vertebra.” (Ex.
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`2005 ¶ 33.) To afford both, one of ordinary skill would understand that the
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`“opening” recitation of independent claims 7 and 10 requires a hole that
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`necessarily extends through the spinal fusion implant from proximate the top
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`thereof to proximate the bottom thereof in the space between the trailing face, the
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`insertion face, and the first and second sides of the spinal fusion implant. (Ex.
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`2005 ¶ 33.) Furthermore, given that the opening permits “the growth of bone
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`through said implant from the first vertebra to the second vertebra,” the “opening”
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`recitation makes it clear that the implants of independent claims 7 and 10 are spinal
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`fusion implants. (Ex. 2005 ¶ 33.)
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`Regarding the claim recitation “opening,” NuVasive observes that “nothing
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`in [the opening] claim limitation recited in each of claims 7 and 10 requires that the
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`- 15 -
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`claimed ‘opening’ must extend through the upper or lower bearing surface.” (‘396
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`
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`Brantigan Dec. (Ex. 1101) ¶ 47.) In response, Warsaw submits that NuVasive’s
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`observation regarding the upper and lower bearing surfaces is something of a
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`misnomer. NuVasive is correct that the claim recitation “opening” does not
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`require that the opening extends through the upper or lower bearing surface.
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`However, to permit growth of bone through the spinal fusion implant from the first
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`vertebra to the second vertebra, the claim recitation “opening” does require a hole
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`that extends through the spinal fusion implant from proximate the top thereof to
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`proximate the bottom thereof.
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`2. Meaning of the claim recitation “ratchetings.”
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`Independent claims 7 and 10 each recite “ratchetings on each of said upper
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`and lower bearing surfaces adapted to engage the first vertebra and the second
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`vertebra, respectively, each of said ratchetings having a ridge oriented in a
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`direction generally parallel to the width of said implant, said ratchetings on each of
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`said upper and lower bearing surfaces facing one direction.”
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`The ratchetings disclosed in the ‘696 patent are used to afford “one-way
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`insertion” of the spinal fusion implant between the adjacent vertebrae. (‘696 patent
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`8:42-47.) Furthermore, once inserted therebetween, the ratchetings prevent the
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`spinal fusion implant from backing out from between the adjacent vertebrae. (‘696
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`patent 8:46-47.)
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`- 16 -
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`As understood by one of ordinary skill, the ordinary and customary meaning
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`of the claim term “ratchetings” in light of the specification and drawings of the
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`‘696 patent is facets that are angled to afford forward movement of the spinal
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`fusion implant in one direction and facets that are angled to prevent the spinal
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`fusion implant from backing out in the opposite direction. (Ex. 2005 ¶ 38.) Thus,
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`one of ordinary skill would understand the recitation of “ratchetings” of
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`independent claims 7 and 10 in light of the specification and drawings of the ‘696
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`patent to require facets that are angled to afford forward movement of the spinal
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`fusion implant in one direction and facets that are angled to prevent the spinal
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`fusion implant from backing out in the opposite direction provided on each of the
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`upper and lower bearing surfaces, further limited to require that the ratchetings on
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`the upper and lower bearing surfaces are adapted to engage the first vertebra and
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`the second vertebra, respectively, and the ratchetings on the upper and lower
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`bearing surfaces each have a ridge oriented in a direction generally parallel to the
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`width of the spinal fusion implant and face one direction. (Ex. 2005 ¶ 38.)
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`3. Meaning of the claim recitation “portions of said first side and
`said second side being substantially flat.”
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`Independent claims 7 and 10 each recite “portions of said first side and said
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`second side being substantially flat, said substantially flat portions intersecting a
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`second plane that is perpendicular to the first plane and extends through said
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`insertion face and said trailing face, wherein said substantially flat portions of said
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`- 17 -
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`first side and said second side are symmetrical about the first plane.” Regarding
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`this claim recitation, the Board indicated that “the claim language encompasses
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`sides that are outwardly bowed, with the proviso that there is some small portion
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`on each side that is “substantially planar.” (Board Decision 9:24-25.) In response,
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`it is noted that this claim recitation is not relied upon by Warsaw to distinguish the
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`rejections preliminarily adopted by the Board. Furthermore, it is noted that Dr.
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`Brantigan, NuVasive’s expert, indicated that it does not make any difference to his
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`analysis of the cited references whether the claim recitation of “substantially flat”
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`means flat. (See Brantigan Dep. (Ex. 2009) 38:19 to 39:6.) As such, Warsaw
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`submits that it is unnecessary for the Board to construe the meaning of this claim
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`recitation to decide the present case.
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`4. Claim recitation of “the converging angular relationship of said
`upper and lower bearing surfaces.”
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`Independent claim 7 recites that “the converging angular relationship of said
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`upper and lower bearing surfaces maintaining the first vertebra and the second
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`vertebra adjacent to said upper and lower bearing surfaces in an angular
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`relationship to maintain the desired lordosis between the first vertebra and the
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`second vertebra.” Dr. Brantigan asserts that the recitation of “maintaining the first
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`vertebra and the second vertebra adjacent to said upper and lower bearing surfaces
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`in an angular relationship” is inconsistent with Patent Office guidelines prohibiting
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`claiming of a part of a patient’s body. (‘396 Brantigan Dec. (Ex. 1101) ¶ 15.) In
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`- 18 -
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`response, Warsaw submits tha
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