`571—272—7822
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`Paper 62
`Date: July 10, 2014
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`NUVASIVE, INC.,
`Petitioner,
`
`V-
`
`WARSAW ORTHOPEDIC, INC,
`
`Patent Owner.
`
`Case IPR2013-OO208
`
`Patent 8,251,997 BZ
`
`Before SALLY C- MEDLEY, LORA M- GREEN, and STEPHEN C- SIU,
`Administrative Patent Judges.
`
`SIU, Administrative Patent Judge.
`
`FINAL WRITTEN DECISION
`
`35 use § 318(a) and 37 (113.12- § 42. 73
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`I. BACKGROUND
`
`NuVasive, Inc. (“Petitioner”) filed a petition (Paper 5) (“Pet”)
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`seeking inierparies review of claims 1—8 of US. Patent No. 8,251,997 BZ
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`(Ex. 1002, “the ’997 patent”) pursuant to 35 U.S.C. §§ 311—319.1 On
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`1 We cite to Petitioner’s Corrected Petition for Inter Paries Review of
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`United States Patent No. 8,251,997 B2, filed April 3, 2013. Paper 5.
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`1PR2013—00208
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`Patent 8,251,997 B2
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`September 23, 2013, the Board instituted an interparres review of all claims
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`(Paper 16) (“Dec. on 1nst.”).
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`Subsequent to institution, Warsaw Orthopedic, Inc. (“Patent Owner”)
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`filed a Patent Owner Response (Paper 29) (“PO Resp”), and Petitioner filed
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`a Reply (Paper 40) (“Pet. Reply”). Patent Owner also filed a Motion to
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`Exclude Evidence. Paper 50. Petitioner filed an Opposition to Patent
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`Owner’s Motion to Exclude (Paper 56) (“Opp”), and Patent Owner filed a
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`Reply (Paper 57) (“PO Reply”). An Oral Hearing was conducted on June 5,
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`2014, pursuant to a request for oral hearing filed by Petitioner (Paper 49)
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`and Patent Owner (Paper 51)-
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`The Board has jurisdiction under 35 U.S.C. § 6(c). This final written
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`decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
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`For the reasons that follow, we determine that Petitioner has shown by
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`a preponderance of the evidence that claims 1—8 of the ’997 patent are
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`unpatentable.
`
`A.
`
`The ’997 Patent (Ex. 1002)2
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`The ”997 patent describes methods and instrumentation for
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`performing surgery on the spine along its lateral aspect. Ex. 1002, 33436;
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`Figs. 1 and 2. Guide pin 30 is inserted from the lateral approach to the spine
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`and functions as a guide post for distractor 100 that is placed over the guide
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`pin and inserted into the disc space to distract the vertebrae. Ex. 1002, 8:52—
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`53; 9:12—14; 10: 10—12; Figs. 2—5. Extended outer sleeve 140 is placed over
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`the distractor and inserted into the disc space. Ex. 1002, 10:22—25, Fig. 12.
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`A spinal implant 1 is introduced through the extended outer sleeve and
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`2 We refer to Ex. 1002 submitted by Petitioner and dated March 22, 2013.
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`2
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`installed across the disc space. Ex. 1002, 15:64—65; 16:24—26; Figs. 19,22,
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`23, 30, and 30A.
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`B.
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`Illustrative Claim
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`Claim 1 is illustrative of the claimed subject matter of the ”997 patent,
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`and is reproduced as follows:
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`A method comprising:
`1.
`making an incision in skin of a patient’s body to gain access to
`a disc space between two adjacent vertebrae located within a portion
`of one of a human thoracic or lumbar spine, said portion of one of the
`human thoracic or lumbar spine defined by the two adjacent vertebrae
`having an anterior aspect and a posterior aspect being divided by a
`first plane through transverse processes of the two adjacent vertebrae,
`the disc space having a depth measured from an anterior aspect to a
`posterior aspect of the disc space, each of the two adjacent vertebrae
`having a vertebral body having a transverse width perpendicular to the
`depth of the disc space, said incision being proximate an intersection
`of the skin and 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;
`advancing a first surgical instrument having a length into the
`body of the patient through said incision until proximate the disc
`space along said path and anterior to the transverse processes;
`advancing a second surgical instrument into the body of the
`patient through said incision and over at least a portion of the length
`of said first surgical instrument, said second surgical instrument
`having a distal end and an opposite proximal end and a length
`therebetween, said second surgical instrument having a passageway
`configured to receive a portion of the length of said first surgical
`instrument therein;
`advancing a third surgical instrument into the body of the
`patient through said incision and over at least a portion of the length
`of said second surgical instrument, said third surgical instrument
`having a distal end for insertion over said second surgical instrument
`and an opposite proximal end;
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`3
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`positioning said third surgical instrument such that said distal
`end of said third surgical instrument is proximate a lateral aspect of
`the vertebral bodies of the two adjacent vertebrae; and
`inserting, from the position anterior to the transverse processes
`of the two adjacent vertebrae and along said path, a non—bone
`interbody intraspinal implant through said third surgical instrument
`into a laterally facing opening in said portion of one of the human
`thoracic or lumbar spine, said implant having an insertion end for
`insertion first into the laterally facing opening and a trailing end and a
`length therebetween, the length of said implant being sized to occupy
`substantially the full transverse width of the vertebral bodies of the
`two adjacent vertebrae, the length of said implant being greater than
`the depth of the disc space, said implant having opposed surfaces
`oriented toward each of the vertebral bodies of the two adjacent
`vertebrae when inserted therebetween, said opposed surfaces having
`bone engaging projections configured to engage the vertebral bodies
`of the two adjacent vertebrae, said implant having a maximum height
`between said bone engaging projections of said opposed surfaces and
`perpendicular to the length of said implant, the length of said implant
`being greater than the maximum height of said implant.
`
`C.
`
`Cited Prior A r!
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`The pending grounds of unpatentabililty in this inter partes review are
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`based on the following prior art:
`
`Jacobson
`Brantigan
`Frey
`Michelson ’247
`Alcareu
`
`us 4,545,374
`us 5,192,327
`Us 4,917,704
`US 5,015,247
`EP 0567424
`
`Oct. 8, 1985
`Mar. 9, 1993
`Apr. 17, 1990
`May 14, 1991
`Oct. 27, 1993
`
`(Ex. 1004)
`(Ex. 1006)
`(Ex. 1007)
`(Ex. 1008)
`(Ex. 1009)
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`Hansjorg F. Leu and Adam Schreiber; Percuianeous Fusion ofthe
`Lumbar Spine: A Promising Technique, 6(3) SPINE: STATE OF THE ART
`REVIEWS 593 (Sept. 1992) (Ex. 1005, “Leu”).
`
`D.
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`Pending Grounds of Unpatemabilily
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`4
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`This interparres review involves the following asserted grounds of
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`unpatentability:
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`Reference(s)
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`Basis
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`Claims challenged
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`
`
`
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`1 and 8
`Jacobson, Leu, and
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`Michelson ’247
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`1and8
`Jacobson, Leu, and
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`Brantigan
`Jacobson, Leu, Michelson
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`’247, and Alacreu
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`Jacobson, Leu, Brantigan,
`and Fre
`
`E.
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`Claim Interpretation
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`The parties appear to agree with the interpretation of various claim
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`terms of the ’997 patent as described in the Decision on Institution with
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`additions or modifications as set forth below. We incorporate our previous
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`analysis for the non-disputed claim terms.
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`1.
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`“a path having an axis lying in a coronal plane passing through
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`a lateral aspect and a medial aspect of the two adjacent vertebrae and
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`anterior to the transverse processes” (claim 1)
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`Patent Owner argues that an “axis lying in a coronal plane” should be
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`construed as an axis that is lying in “a plane at right angles to a sagittal
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`plane.” PO Resp. 10—1 1. Petitioner does not contest Patent Owner’s
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`assertion that one of ordinary skill in the art would understand that a
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`“coronal plane” would be oriented “at right angles to a sagittal plane.” Pet.
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`Reply 1. Thus, no further construction of this term is necessary.
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`2.
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`“non—bone interbody intraspinal implant” (claim 1)
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`5
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`Patent Owner argues that the term “non-bone interbody intraspinal
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`implant” should be construed such that “the composition of the implant does
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`not include any bone” because “the prefix ‘non’ is commonly understood to
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`exclude the thing specified after the word.” PO Resp. 12—13, citing Ex.
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`2038 1] 63. We agree that one of ordinary skill in the art would have
`
`understood that the prefix “non” indicates that the implant contains material
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`that is not bone. Patent Owner does not show persuasively, however, that,
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`under a broad but reasonable construction, one of ordinary skill in the art
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`would have understood that it cannot contain any component derived from
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`bone.
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`Hence, we broadly, but reasonably, construe a “non-bone interbody
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`instraspinal implant” as an implant that contains at least one component that
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`does not contain bone.
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`11. ANALYSIS
`
`A.
`
`Grounds Based at Least in Part on Jacobson, Lea, and Bramigan
`(C'Iaims [—8)
`
`Claim 1 recites a path having an axis lying in a coronal plane passing
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`through a lateral aspect and a medial aspect of the two adjacent vertebrae.
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`Patent Owner contends that a path having an axis lying in a coronal plane, as
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`recited in claim 1, must be a path that is “a direct or ‘true’ lateral path [to the
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`spine].” PO Resp. ll. Petitioner concurs. Pet. Reply 1.
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`Jacobson
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`“lateral ”
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`Jacobson discloses a procedure in which “a cannula is passed laterally
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`through the body,” a needle that “is insetted laterally through the patient’s
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`side” that “may act as a guide member .
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`.
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`. for instruments that create the
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`6
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`percutaneous body channel,” a speculum that “is laterally inserted through
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`body tissue” and is “used to create the lateral cavity through body tissue into
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`which the cannula will be inserted.” Ex- 1004, 511—2, 5:27—28, 5:49—51,
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`5:40—42, 8:53—55. Jacobson also provides drawings of the approach to the
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`intervertebral space. The drawings depict a lateral approach to the
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`intervertebral space, consistent with the textual description. Ex. 1004, Figs.
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`1—6.
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`Patent Owner argues that while Jacobson discloses accessing a disc
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`space from a “lateral” aspect, the term “lateral” “has any number of
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`meanings, including anterolateral, posterolateral, direct lateral, and lateral to
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`the midline of the vertebral bodies” and that, despite Jacobson’s disclosure
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`of a “lateral” approach, Jacobson actually “discloses a posterolateral — not a
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`direct lateral — approach to the spine.” PO Resp. 19 (citing Ex. 2039,
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`37:25 — 39:1).
`
`Petitioner provides testimony of Dr. Robert E. Jacobson to
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`demonstrate what one of ordinary skill in the art would have understood the
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`term “lateral” to mean in the context of performing a spinal fusion
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`procedure- Ex. 1030 11 5. Dr- Jacobson testifies that one of ordinary skill in
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`the art would not have used (or understood) the term “direct lateral” but,
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`instead, would have used the term “lateral” as Patent Owner uses the term in
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`the present proceedings.3 We credit Dr. Jacobson’s testimony that one of
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`ordinary skill in the art would have understood the term “lateral” to mean
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`3 Dr. Jacobson testifies that “the phrase ‘direct lateral’ was not a phrase that I
`used in the technical parlance of my profession .
`.
`. at that time I had never
`heard the phrase ‘direct lateral’ to describe a 90 degree lateral approach to
`the spine. Instead, .
`.
`. I (and others) simply used the term ‘lateral’ when
`referring to a 90 degree lateral approach to the spine.” Ex. 1030 115.
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`7
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`what it says (i.e., to mean “lateral”), at least because it would have been
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`reasonable for one of ordinary skill in the art to have construed a term (i.e.,
`
`“lateral”) with a plain and common definition. Patent Owner’s observation
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`that a construction of the term “lateral” that was in use at the time of the
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`invention included a “direct lateral” approach (as understood in this
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`proceeding) further supports Dr. Jacobson’s testimony that one of ordinary
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`skill in the art would have understood the term “lateral” to mean “direct
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`lateral,” as that term is presently construed in the instant proceedings- Also,
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`we note that claim 1 does not recite the term “direct lateral,” and Patent
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`Owner does not assert that the ’997 patent specification discloses the term
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`“direct lateral,” The absence of the term “direct lateral” in the “997 patent
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`further supports that one of ordinary skill in the art at the time of the
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`invention would not have used (or understood) the term “direct lateral.”
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`In addition to Jacobson’s explicit disclosure of, for example, “laterally
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`inserting a cannula,” Jacobson discloses figures that illustrate what Patent
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`Owner now refers to as a “direct lateral” approach (i.e., lateral insertion
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`along a path having an axis lying in a coronal plane). Ex. 1004, 2:26—27,
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`Figs. 3—8. We note that in each of the figures of Jacobson, the outer side
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`periphery of the instrument(s) inserted “laterally” into the intervertebral
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`space, as illustrated, are depicted by parallel lines that are oriented at 90
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`degrees from a horizontal surface. Based on the depiction of the outer side
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`contours of the instrument(s) as being oriented 90 degrees from a horizontal
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`surface, one of ordinary skill in the art would have understood that the
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`instrument(s) are perpendicular to an underlying horizontal surface in the
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`superior—inferior perspective (with respect to the orientation of the patient).
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`More importantly, as the outer side contours of the instruments are parallel
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`8
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`in these perspectives, one of ordinary skill in the art would have understood
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`the instruments, as illustrated by Jacobson, to be perpendicular to an
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`underlying horizontal surface in the medial—lateral perspective (with respect
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`to the orientation of the patient — i.e., that the orientation of the instrument(s)
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`is “direct lateral,” as Patent Owner uses that phrase, and not “posterolateral”
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`or “anterolateral”). That is true because, assuming the instrument(s)
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`illustrated in Jacobson are cylindrical, if the instrument(s) were angled away
`
`from the viewer, the outer side contours of the instrument(s) at the point of
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`insertion into the intervertebral space would appear farther away from each
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`other as compared to the outer side contours of the instrument(s) at the point
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`farthest from the point of insertion into the intervertebral space (i.e., the
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`proximal end of the instrument(s), which would be located farther away
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`from the viewer). Likewise, if the instrument(s) were angled toward the
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`viewer, the outer side contours of the instrument(s) at the point of insertion
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`into the intervertebral space would appear closer to each other as compared
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`to the outer side contours of the instrument(s) at the point farthest from the
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`point of insertion into the intervertebral space (i.e., the proximal end of the
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`instrument(s), which is located closer to the viewer).
`
`Moreover, as Petitioner’s declarant (Dr. Paul McAfee) points out, an
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`anterior cross sectional View of the instrument(s) in-situ (i.e., Ex. 1004, Fig.
`
`6) shows an even and symmetrical view of the instruments throughout the
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`length of the instrument(s). See, eg, Ex. 1029 1] 38. Dr. McAfee’s
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`testimony further supports that Jacobson discloses that the instruments are
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`inserted along a path having an axis lying in a coronal plane passing through
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`a lateral aspect and a medial aspect of the two adjacent vertebrae, as recited
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`in claim 1 (i.e., the “direct lateral” approach as presently understood in the
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`instant proceedings).
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`Patent Owner argues that the figures as disclosed by Jacobson “appear
`
`to show a direct lateral path,” but “do not clearly show the surgical
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`approach” because the figures “are merely two—dimensional depictions [that
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`depict the same orientation]” and that “these figures [of Jacobson] could just
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`as likely disclose a posterolateral or anterolateral approach to the spine.” PO
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`Resp. 23—24 (citing Ex. 2038 1] 81)- Patent Owner does not explain
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`adequately, however, how the anterior view of instrument(s) illustrated in
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`Jacobson with parallel outer side contours as described above or the anterior
`
`cross sectional view of the instrument(s) throughout the length of the
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`instrument(s) as also described above (i.e., instrument(s) that are normal to
`
`an underlying horizontal surface), “could just as likely” illustrate
`
`instrument(s) that are angled with respect to an underlying horizontal
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`surface. While Patent Owner also argues that “surgeons are trained to orient
`
`an instrument in a patient’s body by taking images of the instrument from
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`multiple angles,” Patent Owner does not demonstrate persuasively that, even
`
`if surgeons are trained to take images at multiple angles, that Jacobson
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`illustrates that the instrument(s) are angled (i.e., a posterolateral or
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`anterolateral approach). PO Resp. 24 (citing Ex. 2038, 11 81).
`
`Patent Owner argues that Jacobson “discloses a method of performing
`
`percutaneous discectomy that implicates anatomical structures such as the
`
`spinal nerves and nerve root — structures that are encountered during a
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`posterolateral (not direct lateral) approach to the spine” and a “stimulator
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`[that] will cause motion in one of the patient’s legs if it makes nerve contact
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`[and that motor nerves are implicated only in a posterolateral approach.]”
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`10
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`PO Resp. 19—20 (citing Ex. 2038 W 76—77; Ex. 1004, 6:38—40). As Patent
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`Owner indicates, Jacobson discloses “[t]o prevent nerve damage, a nerve
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`stimulator .
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`.
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`. may be attached or passed down into the cannula or trocar to
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`indicate if either instrument is hitting one of the spinal nerves or exiting
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`nerve branches.” Ex. 1004, 6:32—38.
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`It is not disputed that Jacobson
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`discloses a “lateral approach” that includes a “direct lateral” approach, as
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`construed in the instant proceedings (see discussion above). Also, as
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`described above, Jacobson discloses illustrations of a spinal fusion
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`procedure in which instruments are inserted into an intervertebral space (i.e-,
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`a “direct lateral” approach as presently understood) while oriented normal to
`
`an underlying horizontal surface (i.e., having an axis lying in a coronal plane
`
`passing through a lateral aspect and a medial aspect of the two adjacent
`
`vertebrae). Patent Owner does not demonstrate sufficiently how Jacobson’s
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`further disclosure of the possible use of a “nerve stimulator” that indicates if
`
`an attached instrument contacts a nerve means that Jacobson does not
`
`disclose or suggest a (“direct”) lateral approach. For example, regardless of
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`which approach Jacobson discloses, a “nerve stimulator” allegedly would be
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`capable of detecting contact with a nerve because the functionality of a
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`“nerve stimulator” would not be affected by whatever approach is disclosed
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`by Jacobson.
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`Patent Owner argues that one of ordinary skill in the art would have
`
`understood that “the clearest path to a disc space is posterolaterally [and not
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`direct lateral, as that term is used in these proceedings].” PO Resp. 20.
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`Patent Owner further contends that Jacobson discloses using “a spinal
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`needle” to anesthetize the patient and that, based on this disclosure and the
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`allegation that a posterolateral (and not “direct lateral”) approach is the
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`11
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`“clearest path” that avoids the bowel, one of ordinary skill in the art would
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`have understood that Jacobson discloses a posterolateral approach and not a
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`“direct lateral” approach- PO- Resp- 21—22. As previously described,
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`however, Jacobson discloses a “lateral” approach, which includes a so—called
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`“direct lateral” approach and illustrates such an approach. Patent Owner
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`does not show persuasively that one of ordinary skill in the art, given these
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`explicit teachings, would have understood that the apparent “direct lateral”
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`approach of Jacobson is actually a “posterolateral” approach based on
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`Jacobson’s disclosure of one choice of method of administering an
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`anesthetic-
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`In any event, as Patent Owner indicates, Jacobson discloses a “go-n0-
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`go” indicator that determines if the needle can be used. If the needle of
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`Jacobson cannot be used, “the procedure cannot be used on this particular
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`patient.” 1d. at 21 (citing Ex. 1004, 5:23—36). In other words, Jacobson
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`discloses that if the needle cannot be safely used on a particular patient, the
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`procedure is not performed- Even assuming Patent Owner’s contention to be
`
`correct that using a so—called “direct lateral” approach carries a risk of bowel
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`perforation, Jacobson explicitly addresses any such potential complications
`
`of the procedure. Hence, we are not persuaded that the potential use (or
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`non-use) of a needle in Jacobson would suggest to one of ordinary skill in
`
`the art of a particular route of entry of the needle in a patient.
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`Patent Owner argues that Jacobson discloses a procedure that “can ‘be
`
`performed in approximately 15 minutes,” and that one of ordinary skill in
`
`the art would have understood that performing the procedure using a “direct
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`lateral” approach would have taken “significantly longer than” 15 minutes.
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`Id. at 22 (citing Ex. 2038 fl 86). Based on this assumption, Patent Owner
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`l2
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`contends that Jacobson discloses a posterolateral approach. Jacobson
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`discloses that “[i]nstruments constructed in accordance with the invention
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`allow the procedure to be performed in approximately 15 minutes under only
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`local anesthesia.” Ex. 1004, 2:54—57.
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`Patent Owner’s declarant (Dr- Barton L. Sachs) testifies that
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`“[p]erforrning such a procedure in 15 minutes is far more consistent with an
`
`approach that is [posterolateral] than one that is direct lateral” and that “[i]n
`
`my opinion, a direct lateral discectomy would take significantly longer than
`
`15 minutes.” Ex. 2038 1] 87. However, Dr. Sachs testifies that he is of the
`
`opinion that a 15 minute procedure is “consistent with” a posterolateral
`
`procedure, but does not assert or provide sufficient evidence to suggest that
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`one of ordinary skill in the art would have understood that such a procedure
`
`taking 15 minutes or less would not have used the so-called “direct lateral”
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`approach. In addition, even assuming Patent Owner’s implication that
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`performance of spinal fusion using the so-called “direct lateral” approach
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`could never be completed within 15 minutes, we note that Dr. Sachs testifies
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`that the so—called “direct lateral” approach takes longer than 15 minutes
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`because such an approach “requires care to deal with anatomical structures
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`such as the peritoneum, the bowel, vascular structures, and the psoas
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`muscle.” Ex. 2038 11 87. Jacobson discloses that the procedure takes
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`“approximately 15 minutes under only local anesthesia,” suggesting that
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`Jacobson’s time estimate of 15 minutes would not include the time for
`
`administering anesthesia (or advancing a needle to administer the
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`anesthetic). Hence, one of ordinary skill in the art would have understood
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`that the alleged “rate-limiting” step (according to Dr. Sachs) of dealing with
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`the bowel, for example, would not be included in Jacobson’s time estimate
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`13
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`IPR2013—00208
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`Patent 8,251,997 B2
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`of 15 minutes. Dr. Sachs (and Patent Owner) does not demonstrate that one
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`of ordinary skill in the art would have understood that the so-called “direct
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`lateral” approach must take longer than 15 minutes, even after the
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`“anatomical structures” that Dr- Sachs cites are already “dealt with-”
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`Patent Owner argues that Jacobson discloses “placement of a patient
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`in a lateral decubitus position [that] does not necessarily mean his approach
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`is directly lateral.” PO Resp. 23. Patent Owner does not demonstrate
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`sufficiently, however, that one of ordinary skill in the art would have
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`understood that placement of a patient in a lateral decubitus position would
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`mean necessarily the approach is something other than the so-called “direct
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`latera ” approach, particularly in view of the previously discussed disclosure
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`of Jacobson suggesting to one of ordinary skill in the art that the approach
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`disclosed is the so—called “direct lateral” approach.
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`Jacobson discloses that the surgical procedure is a “fusion” surgical
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`procedure. Ex. 1004, 6: 13. Petitioner states that “a ‘fusion’ procedure .
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`.
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`.
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`necessarily includes the insertion of an implant into the disc space.” Pet- 18-
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`Hence, Petitioner argues that Jacobson discloses or suggests an implant.
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`Patent Owner argues that a fusion surgical procedure “can be with or
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`without an implant” and that an “[i]nherent disclosure by a prior art
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`reference ‘is appropriate only when the reference discloses prior art that
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`must necessarily include the unstated limitation.” PO Resp. 25 (citing Ex.
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`2039, 26:23 — 27:1). Hence, Patent Owner argues that a fusion surgical
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`procedure does not necessarily include the insertion of an implant-
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`Based on the record, we agree with Patent Owner that a “fusion”
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`surgical procedure does not require the insertion of an implant in every
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`instance. Therefore, we agree with Patent Owner that a “fusion” surgical
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. - IPR2019-00362, Ex. 1018, p, 14 of 36
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`procedure does not “necessarily” include the insertion of an implant. We
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`disagree, however, with Patent Owner’s implication of a requirement of
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`showing a claim limitation is inherently present in a prior art reference to
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`support a prima facie showing of obviousness of the disputed claims over a
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`combination of references. For example, a “single prior art reference that
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`discloses, either expressly or inherently, each limitation of a claim
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`invalidates that claim by anticipation.” Perrieone v. Medicis Pharm. Corp,
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`432 F.3d 1368, 1375 (Fed. Cir. 2005)-
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`In the present case, the ground of
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`unpatentability in dispute is not “by anticipation.” Hence, whether the
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`“fusion” surgical procedure of Jacobson “necessarily” includes insertion of
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`an implant has not been shown to be relevant to the present proceedings.
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`“imp/am being sized to oeeugv .S'ubsiamiaIZy the
`Brantigan
`fit}! transverse widths 0fthe vertebrai bodies ”4
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`Claim 1 recites the length of an implant being sized to occupy
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`substantially the full transverse widths of the vertebral bodies of the two
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`adjacent vertebrae. Petitioner argues that Brantigan discloses or suggests
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`this feature. See, 6.3., Pet. 28. Patent Owner argues that Brantigan discloses
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`implants that are “shaped to conform with the general outline perimeter of
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`the vertebrae,” but fails to disclose or suggest that “the implant is sized to
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`trace the outline perimeter of the [vertebrae].” P0 Resp. 34. As Petitioner
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`points out, however, Brantigan discloses, for example, a “plug .
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`.
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`. generally
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`shaped and sized to conform with the disc space between adjoining vertebrae
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`4 Patent Owner argues that “[t]he doctrine of collateral estoppel precludes
`Petitioner from relitigating its rejected interpretation of the disclosures of
`Brantigan.” PO Resp- 39. After careful consideration, we are not persuaded
`by Patent Owner’s arguments for at least the reasons previously stated. See,
`eg, Dec. on Inst. 12.
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`15
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. - IPR2019-00362, Ex. 1018, p, 15 of 36
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`in a vertebral column.” Ex. 1006, 4:6—8. Hence, Brantigan discloses an
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`implant that is both shaped and sized with regard to the disc space.
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`Patent Owner argues that Brantigan discloses an implant “that is
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`designed to sit within the apophyseal ring” and “designed to sit in the central
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`region of adjacent vertebral bodies where bone tends to be more cancellous
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`and vascular.” PO Resp. 36, 38 (citing Ex. 1006, 2: 15—16 and Fig. 1; Ex.
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`2041, 1520:2—16; Ex. 2039, 50:1—10; Ex. 2038 1] 110). Hence, Patent
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`Owner argues that Brantigan fails to disclose an implant that includes (or
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`overlaps) the apophyseal ring of a vertebral body or extends beyond a
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`central region of a vertebral body- As previously described, claim 1 recites
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`an implant being sized to occupy substantially the full transverse width of
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`the vertebral body. Patent Owner does not show that claim 1 also recites an
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`implant being sized to extend onto the apophyseal ring of the vertebral body
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`or an implant being sized to extend beyond a central region of a vertebral
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`body. Nor does Patent Owner point to an explicit disclosure in the
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`Specification regarding the length of the implant with respect to the alleged
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`“apophyseal ring-” We, therefore, are not persuaded by Patent Owner’s
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`contention.
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`Patent Owner argues that Brantigan discloses an implant “conforming
`37'}
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`in shape and size with opposing hard endplates of vertebrae
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`that does not
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`“include the outer periphery (or apophyseal ring) of a vertebral body” or
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`“the entire vertebral body.” PO Resp. 34—35 (citing Ex. 2038 ‘H 29). As an
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`initial matter, claim 1 recites an implant being sized to occupy substantially
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`the full transverse width of the vertebral body. Hence, claim 1 requires that
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`the implant occupy “a length that is less than the full transverse width of the
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`vertebral bodies by an insubstantial amount.” Dec. on Inst. 9. Patent Owner
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`l6
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. - IPR2019-00362, Ex. 1018, p, 16 of 36
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`does not demonstrate that claim 1 requires that the implant includes “the
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`entire vertebral body.”
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`Also, as discussed above, Brantigan discloses that the implant is
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`“sized to conform with the disc space between adjoining vertebrae.” Ex.
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`1006, 4:6—7. We construe the term “disc space” of claim 1 broadly but
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`reasonably and in light of the Specification to include a space between
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`adjacent vertebral bodies. We agree with Petitioner that it would have been
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`obvious to one of ordinary skill in the art that an implant that is “sized to
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`conform with the disc space,” as disclosed by Brantigan, would have
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`occupied at least a length that is less than the full transverse width of the
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`vertebral bodies by an insubstantial amount (i.e., occupying “substantially”
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`the full transverse width). Otherwise, an implant that does not occupy
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`“substantially” the full transverse width would not have been sized to
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`conform to the disc space, in contrast to Brantigan’s disclosure that the
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`implant is, in fact, sized to conform to the disc space.
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`Dr. Sachs testifies that the vertebral body contains a “vertebral
`)9 6‘
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`endplate ” that “is typically vascular,” an “apophyseal ring
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`anatomically
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`distinct from the vertebral endplate” and “almost entirely avascular” located
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`“[t]oward the vertebral periphery,” and a “cortical rim” “distinct from the
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`apophyseal ring” located “[a]t the very edge of the vertebral body.” Ex.
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`2038 1] 29.
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`While Dr- Sachs provides testimony on the anatomy of the
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`intervertebral space and disc, Dr. Sachs does not appear to provide testimony
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`supporting Patent Owner’s implied contention that one of ordinary skill in
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`the art would have considered the term “occupying substantially the full
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`transverse width of the vertebral body,” as recited in claim 1, to mean
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. - IPR2019-00362, Ex. 1018, p, 17 of 36
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`“occupying no more than the width of the vettebral endplate” or “occupying
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`(or not occupying) any portion of the apophyseal ring,” Hence, even
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`assuming that Dr. Sachs’ characterization of the anatomy of the
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`intervertebral disc space and vertebral bodies is correct, the testimony of Dr-
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`Sachs provides insufficient evidence to refute the prima facie showing that it
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`wo