Paper 65
`
`Trials@uspto.gov
`Date: July 10, 2014
`
`571-272-7822
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`____________
`
`NUVASIVE, INC.,
`Petitioner,
`
`v.
`
`WARSAW ORTHOPEDIC, INC.,
`Patent Owner.
`____________
`
`Case IPR2013-00206
`Patent 8,251,997 B2
`____________
`
`Before SALLY C. MEDLEY, LORA M. GREEN, and STEPHEN C. SIU,
`Administrative Patent Judges.
`
`SIU, Administrative Patent Judge.
`
`
`FINAL WRITTEN DECISION
`35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
`
`
`
`
`I. BACKGROUND
`NuVasive, Inc. (“Petitioner”) filed a petition (Paper 5) (“Pet.”)
`seeking inter partes review of claims 9–30 of U.S. Patent No. 8,251,997 B2
`(Ex. 1002, “the ’997 patent”) pursuant to 35 U.S.C. §§ 311–319. 1 On
`
`
`1 We cite to Petitioner’s Corrected Petition for Inter Partes Review of
`United States Patent No. 8,251,997 B2, filed April 3, 2013. Paper 5.
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`September 23, 2013, the Board instituted an inter partes review of all claims
`on six grounds of unpatentability (Paper 17) (“Dec. on Inst.”).
`Subsequent to institution, Warsaw Orthopedic, Inc. (“Patent Owner”)
`filed a Patent Owner Response (Paper 32) (“PO Resp.”), and Petitioner filed
`a Reply (Paper 43) (“Pet. Reply”). Patent Owner also filed a Motion to
`Exclude Evidence. Paper 53. Petitioner filed an Opposition to Patent
`Owner’s Motion to Exclude (Paper 59) (“Opp.”), and Patent Owner filed a
`Reply (Paper 60) (“PO Reply”). An Oral Hearing was conducted on June 5,
`2014, pursuant to a request for oral hearing filed by Petitioner (Paper 52)
`and Patent Owner (Paper 54).
`The Board has jurisdiction under 35 U.S.C. § 6(c). This final written
`decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
`For the reasons that follow, we determine that Petitioner has shown by
`a preponderance of the evidence that claims 17–23 of the ’997 patent are
`unpatentable, but has not shown by a preponderance of the evidence that
`claims 9–16 and 24–30 of the ’997 patent are unpatentable.
`
`
`The ’997 Patent (Ex. 1002) 2
`A.
`The ’997 patent describes methods and instrumentation for
`performing surgery on the spine along its lateral aspect. Ex. 1002, 3:34–36;
`Figs. 1 and 2. Guide pin 30 is inserted from the lateral approach to the spine
`and functions as a guide post for distractor 100 that is placed over the guide
`pin and inserted into the disc space to distract the vertebrae. Ex. 1002, 8:52–
`53; 9:12–14; 10:10–12; Figs. 2–5. Extended outer sleeve 140 is placed over
`the distractor and inserted into the disc space. Ex. 1002, 10:22–25, Fig. 12.
`
`2 We refer to Ex. 1002 submitted by Petitioner and dated March 22, 2013.
`2
`
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`A spinal implant I is introduced through the extended outer sleeve and
`installed across the disc space. Ex. 1002, 15:64–65; 16:24–26; Figs. 19, 22,
`23, 30, and 30A.
`
`
`
`
`Illustrative Claim
`B.
`Claim 9 is illustrative of the claimed subject matter of the ’997 patent,
`and is reproduced as follows:
`9.
`A method comprising:
`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;
`
`3
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`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;
`positioning a single elongated portion removably
`attached to said distal end of said third surgical instrument over
`the disc space, said single elongated portion having a length, a
`thickness, and a width, the length of said single elongated
`portion being greater than the width and the thickness of said
`single elongated portion, the width of said single elongated
`portion being greater than the thickness of said single elongated
`portion, said single elongated portion being tapered to facilitate
`entry between the vertebral bodies of the two adjacent
`vertebrae;
`inserting said single elongated portion into the disc space
`with the width of said single elongated portion being oriented
`along a height of the disc space; and
`inserting, from the position anterior to the transverse
`processes of the two adjacent vertebrae and along said path, an
`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.
`
`
`
`4
`
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`Cited Prior Art
`C.
`The pending grounds of unpatentabililty in this inter partes review are
`based on the following prior art:
`Oct. 8, 1985
`Jacobson
`
`US 4,545,374
`Mar. 9, 1993
`Brantigan
`
`US 5,192,327
`Apr. 17, 1990
`Frey
`
`US 4,917,704
`Michelson ’247 US 5,015,247 May 14, 1991
`McAfee
`
`US 5,569,290
`Oct. 29, 1996
`
`Hansjörg F. Leu and Adam Schreiber; Percutaneous Fusion of the
`Lumbar Spine: A Promising Technique, 6(3) SPINE: STATE OF THE ART
`REVIEWS 593 (Sept. 1992) (Ex. 1005, “Leu”).
`
`
`
`(Ex. 1004)
`(Ex. 1006)
`(Ex. 1007)
`(Ex. 1008)
`(Ex. 1009)
`
`Pending Grounds of Unpatentability
`D.
`This inter partes review involves the following asserted grounds of
`unpatentability:
`Reference(s)
`
`Claims challenged
`
`Basis
`
`9 and 16
`
`10–15
`
`17 and 23
`
`18–22
`
`24 and 30
`
`25–29
`
`§103
`
`§103
`
`§103
`
`§103
`
`§ 103
`
`§ 103
`
`Jacobson, Leu, McAfee,
`and Michelson ’247
`Jacobson, Leu, McAfee,
`Michelson ’247, and Frey
`Jacobson, Leu, and
`Brantigan
`Jacobson, Leu, Brantigan,
`and Frey
`Jacobson, Leu, and
`Michelson ’247
`Jacobson, Leu, Michelson
`’247, and Frey
`
`
`
`5
`
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`Claim Interpretation
`E.
`The parties appear to agree with the interpretation of various claim
`terms of the ’997 patent as described in the Decision on Institution with
`additions or modifications as set forth below. We incorporate our previous
`analysis for the non-disputed claim terms.
`1.
`“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” (claim 9)
`Patent Owner argues that an “axis lying in a coronal plane” should be
`construed as an axis that is lying in “a plane at right angles to a sagittal
`plane.” PO Resp. 11. Petitioner does not contest Patent Owner’s assertion
`that one of ordinary skill in the art would understand that a “coronal plane”
`would be oriented “at right angles to a sagittal plane.” Pet. Reply 1. Thus,
`no further construction of this term is necessary.
`
`“elongated portion” (claim 9)
`2.
`Patent Owner argues that the term “elongated portion” should be
`broadly, but reasonably, construed as a portion in which “its length is
`substantially greater than its width.” PO Resp. 12. Petitioner argues that
`“elongated” should be construed as a portion having a length greater than its
`width. Pet. Reply 1–2. As Petitioner points out, claim 9, for example,
`recites the “length of said single elongated portion being greater than the
`width . . . of said single elongated portion.” Patent Owner does not show
`persuasively that the claims recite a requirement that the length of the
`elongated portion is “substantially” greater than the width of the elongated
`portion or that the Specification discloses such a requirement. Patent Owner
`
`6
`
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`also does not provide a persuasive rationale as to why one of ordinary skill
`in the art would have assumed that the length of the elongated portion is
`“substantially” greater than the width of the elongated portion in view of the
`absence of the disputed qualifier in the claims and Specification.
`We construe the elongated portion as having a length that is greater
`than the width of the elongated portion.
`
`
`
`
`II. ANALYSIS
`A. Grounds Based at Least in Part on Jacobson, Leu, and Brantigan
`(Claims 17–23)
`Claim 17 recites a path having an axis lying in a coronal plane passing
`through a lateral aspect and a medial aspect of the two adjacent vertebrae.
`Patent Owner contends that a path having an axis lying in a coronal plane, as
`recited in claim 17, must be a path that is “a direct or true lateral path to the
`spine.” PO Resp. 11. Petitioner concurs. Pet. Reply 1.
`
`Jacobson – “lateral”
`Jacobson discloses a procedure in which “a cannula is passed laterally
`through the body,” a needle that “is inserted laterally through the patient’s
`side” that “may act as a guide member . . . for instruments that create the
`percutaneous body channel,” a speculum that “is laterally inserted through
`body tissue” and is “used to create the lateral cavity through body tissue into
`which the cannula will be inserted.” Ex. 1004, 5:1–2, 5:27–28, 5:49–51,
`5:40–42, 8:53–55. Jacobson also provides drawings of the approach to the
`intervertebral space. The drawings depict a lateral approach to the
`intervertebral space, consistent with the textual description. Ex. 1004, Figs.
`1–6.
`
`7
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`Patent Owner argues that while Jacobson discloses accessing a disc
`space from a “lateral” aspect, the term “lateral” “has any number of
`meanings, including anterolateral, posterolateral, direct lateral, and lateral to
`the midline of the vertebral bodies” and that, despite Jacobson’s disclosure
`of a “lateral” approach, Jacobson actually “discloses a posterolateral – not a
`direct lateral – approach to the spine.” PO Resp. 19 (citing Ex. 2039,
`37:25 – 39:1).
`Petitioner provides testimony of Dr. Robert E. Jacobson to
`demonstrate what one of ordinary skill in the art would have understood the
`term “lateral” to mean in the context of performing a spinal fusion
`procedure. Ex. 1030 ¶ 5. Dr. Jacobson testifies that one of ordinary skill in
`the art would not have used (or understood) the term “direct lateral” but,
`instead, would have used the term “lateral” as Patent Owner uses the term in
`the present proceedings.3 We credit Dr. Jacobson’s testimony that one of
`ordinary skill in the art would have understood the term “lateral” to mean
`what it says (i.e., to mean “lateral”), at least because it would have been
`reasonable for one of ordinary skill in the art to have construed a term (i.e.,
`“lateral”) with a common, accepted definition. Patent Owner’s observation
`that a construction of the term “lateral” that was in use at the time of the
`invention included a “direct lateral” approach (as understood in this
`proceeding) further supports Dr. Jacobson’s testimony that one of ordinary
`skill in the art would have understood the term “lateral” to mean “direct
`
`
`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 ¶5.
`8
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`lateral,” as that term is presently construed in the instant proceedings. Also,
`we note that claim 17 does not recite the term “direct lateral,” and Patent
`Owner does not assert that the ’997 patent specification discloses the term
`“direct lateral.” The absence of the term “direct lateral” in the ’997 patent
`further supports that one of ordinary skill in the art at the time of the
`invention would not have used (or understood) the term “direct lateral.”
`In addition to Jacobson’s explicit disclosure of, for example, “laterally
`inserting a cannula,” Jacobson discloses figures that illustrate what Patent
`Owner now refers to as a “direct lateral” approach (i.e., lateral insertion
`along a path having an axis lying in a coronal plane). Ex. 1004, 2:26–27,
`Figs. 3–8. We note that in each of the figures of Jacobson, the outer side
`periphery of the instrument(s) inserted “laterally” into the intervertebral
`space, as illustrated, are depicted by parallel lines that are oriented at 90
`degrees from a horizontal surface. Based on the depiction of the outer side
`contours of the instrument(s) as being oriented 90 degrees from a horizontal
`surface, one of ordinary skill in the art would have understood that the
`instrument(s) are perpendicular to an underlying horizontal surface in the
`superior-inferior perspective (with respect to the orientation of the patient).
`More importantly, as the outer side contours of the instruments are parallel
`in these perspectives, one of ordinary skill in the art would have understood
`the instruments, as illustrated by Jacobson, to be perpendicular to an
`underlying horizontal surface in the medial-lateral perspective (with respect
`to the orientation of the patient – i.e., that the orientation of the instrument(s)
`is “direct lateral,” as Patent Owner uses that phrase, and not “posterolateral”
`or “anterolateral”). That is true because, assuming the instrument(s)
`illustrated in Jacobson are cylindrical, if the instrument(s) were angled away
`
`9
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`from the viewer, the outer side contours of the instrument(s) at the point of
`insertion into the intervertebral space would appear farther away from each
`other as compared to the outer side contours of the instrument(s) at the point
`farthest from the point of insertion into the intervertebral space (i.e., the
`proximal end of the instrument(s), which would be located farther away
`from the viewer). Likewise, if the instrument(s) were angled toward the
`viewer, the outer side contours of the instrument(s) at the point of insertion
`into the intervertebral space would appear closer to each other as compared
`to the outer side contours of the instrument(s) at the point farthest from the
`point of insertion into the intervertebral space (i.e., the proximal end of the
`instrument(s), which is located closer to the viewer).
`Moreover, as Petitioner’s declarant (Dr. Paul McAfee) points out, an
`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
`length of the instrument(s). See, e.g., Ex. 1029 ¶ 38. Dr. McAfee’s
`testimony further supports that Jacobson discloses that the instruments are
`inserted along a path having an axis lying in a coronal plane passing through
`a lateral aspect and a medial aspect of the two adjacent vertebrae, as recited
`in claim 17 (i.e., the “direct lateral” approach as presently understood in the
`instant proceedings).
`Patent Owner argues that the figures as disclosed by Jacobson “appear
`to show a direct lateral path,” but “do not clearly show the surgical
`approach” because the figures “are merely two-dimensional depictions [that
`depict the same orientation]” and that “these figures [of Jacobson] could just
`as likely disclose a posterolateral or anterolateral approach to the spine.” PO
`Resp. 23–24 (citing Ex. 2038 ¶ 81). Patent Owner does not explain
`
`10
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`adequately, however, how the anterior view of instrument(s) illustrated in
`Jacobson, with parallel outer side contours as described above or the anterior
`cross-sectional view of the instrument(s) throughout the length of the
`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
`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
`multiple angles,” Patent Owner does not demonstrate persuasively that, even
`if surgeons are trained to take images at multiple angles, that Jacobson
`illustrates that the instrument(s) are angled (i.e., a posterolateral or
`anterolateral approach). PO Resp. 24 (citing Ex. 2038 ¶ 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
`posterolateral (not direct lateral) approach to the spine” and a “stimulator
`[that] will cause motion in one of the patient’s legs if it makes nerve contact
`[and that motor nerves are implicated only in a posterolateral approach.]”
`PO Resp. 19–20 (citing Ex. 2038 ¶¶ 76–77; Ex. 1004, 6:38–40). As Patent
`Owner indicates, Jacobson discloses “[t]o prevent nerve damage, a nerve
`stimulator . . . may be attached or passed down into the cannula or trocar to
`indicate if either instrument is hitting one of the spinal nerves or exiting
`nerve branches.” Ex. 1004, 6:32–38. It is not disputed that Jacobson
`discloses a “lateral approach” that includes a “direct lateral” approach, as
`construed in the instant proceedings (see discussion above). Also, as
`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.,
`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
`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 lateral approach. For example, regardless of which
`approach Jacobson discloses, a “nerve stimulator” allegedly would be
`capable of detecting contact with a nerve because the functionality of a
`“nerve stimulator” would not be affected by whatever approach is disclosed
`by Jacobson.
`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
`direct lateral, as that term is used in these proceedings].” PO Resp. 21.
`Patent Owner further contends that Jacobson discloses “using a long spinal
`needle” to anesthetize the patient and that, based on this disclosure and the
`allegation that a posterolateral (and not “direct lateral”) approach is the
`“clearest path” that avoids the bowel, one of ordinary skill in the art would
`have understood that Jacobson discloses a posterolateral approach and not a
`“direct lateral” approach. PO. Resp. 21–22. As previously described,
`however, Jacobson discloses a “lateral” approach, which includes a so-called
`“direct lateral” approach and illustrates such an approach. Patent Owner
`does not show persuasively that one of ordinary skill in the art, given these
`explicit teachings, would have understood that the apparent “direct lateral”
`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
`anesthetic.
`In any event, as Patent Owner indicates, Jacobson discloses a “go-no-
`go” indicator that determines if the needle can be used. If the needle of
`Jacobson cannot be used, “the procedure cannot be used on this particular
`patient.” Id. at 21 (citing Ex. 1004, 5:23–36). In other words, Jacobson
`discloses that if the needle cannot be safely used on a particular patient, the
`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
`perforation, Jacobson explicitly addresses any such potential complications
`of the procedure. Hence, we are not persuaded that the potential use (or
`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.
`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
`lateral” approach would have taken “significantly longer than” 15 minutes.
`Id. at 23 (citing Ex. 2038 ¶ 86). Based on this assumption, Patent Owner
`contends that Jacobson discloses a posterolateral approach. Jacobson
`discloses that “[i]nstruments constructed in accordance with the invention
`allow the procedure to be performed in approximately 15 minutes under only
`local anesthesia.” Ex. 1004, 2:54–57.
`Patent Owner’s declarant (Dr. Barton L. Sachs) testifies that
`“[p]erforming 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
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`15 minutes.” Ex. 2038 ¶ 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
`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”
`approach. In addition, even assuming Patent Owner’s implication that
`performance of spinal fusion using the so-called “direct lateral” approach
`could never be completed within 15 minutes, we note that Dr. Sachs testifies
`that the so-called “direct lateral” approach takes longer than 15 minutes
`because such an approach “requires care to deal with anatomical structures
`such as the peritoneum, the bowel, vascular structures, and the psoas
`muscle.” Ex. 2038 ¶ 87. Jacobson discloses that the procedure takes
`“approximately 15 minutes under only local anesthesia,” suggesting that
`Jacobson’s time estimate of 15 minutes would not include the time for
`administering anesthesia (or advancing a needle to administer the
`anesthetic). Hence, one of ordinary skill in the art would have understood
`that the alleged “rate-limiting” step (according to Dr. Sachs) of dealing with
`the bowel, for example, would not be included in Jacobson’s time estimate
`of 15 minutes. Dr. Sachs (and Patent Owner) does not demonstrate that one
`of ordinary skill in the art would have understood that the so-called “direct
`lateral” approach must take longer than 15 minutes, even after the
`“anatomical structures” that Dr. Sachs cites are already “dealt with.”
`Patent Owner argues that Jacobson discloses “placement of a patient
`in a lateral decubitus position [that] does not necessarily mean his approach
`is directly lateral.” PO Resp. 23. Patent Owner does not demonstrate
`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
`mean necessarily the approach is something other than the so-called “direct
`lateral” approach, particularly in view of the previously discussed disclosure
`of Jacobson suggesting to one of ordinary skill in the art that the approach
`disclosed is the so-called “direct lateral” approach.
`Jacobson discloses that the surgical procedure is a “fusion” surgical
`procedure. Ex. 1004, 6:13. Petitioner states that “a ‘fusion’ procedure . . .
`necessarily includes the insertion of an implant into the disc space.” Pet. 19.
`Hence, Petitioner argues that Jacobson discloses or suggests an implant.
`Patent Owner argues that a fusion surgical procedure “can be with or
`without an implant” and that an “[i]nherent disclosure by a prior art
`reference ‘is appropriate only when the reference discloses prior art that
`must necessarily include the unstated limitation.’” PO Resp. 25 (citing Ex.
`2039, 26:23 – 27:1). Hence, Patent Owner argues that a fusion surgical
`procedure does not necessarily include the insertion of an implant.
`Based on the record, we agree with Patent Owner that a “fusion”
`surgical procedure does not require the insertion of an implant in every
`instance. Therefore, we agree with Patent Owner that a “fusion” surgical
`procedure does not “necessarily” include the insertion of an implant. We
`disagree, however, with Patent Owner’s implication of a requirement of
`showing a claim limitation is inherently present in a prior art reference to
`support a prima facie showing of obviousness of the disputed claims over a
`combination of references. For example, a “single prior art reference that
`discloses, either expressly or inherently, each limitation of a claim
`invalidates that claim by anticipation.” Perricone v. Medicis Pharm. Corp.,
`432 F.3d 1368, 1375 (Fed. Cir. 2005). In the present case, the ground of
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`ALPHATEC HOLDINGS, INC., ALPHATEC SPINE INC. - IPR2019-00362, Ex. 1017, p. 15 of 37
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`unpatentability in dispute is not “by anticipation.” Hence, whether the
`“fusion” surgical procedure of Jacobson “necessarily” includes insertion of
`an implant has not been shown to be relevant to the present proceedings.
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`Brantigan – “implant being sized to occupy substantially the
`full transverse widths of the vertebral bodies”4
`Claim 17 recites the length of an implant being sized to occupy
`substantially the full transverse widths of the vertebral bodies of the two
`adjacent vertebrae. Petitioner argues that Brantigan discloses or suggests
`this feature. See, e.g., Pet. 28. Patent Owner argues that Brantigan discloses
`implants that are “shaped to conform with the general outline perimeter of
`the vertebrae,” but fails to disclose or suggest that “the implant is sized to
`trace the outline perimeter of the [vertebrae].” PO Resp. 34. As Petitioner
`points out, however, Brantigan discloses, for example, a “plug . . . generally
`shaped and sized to conform with the disc space between adjoining vertebrae
`in a vertebral column.” Ex. 1006, 4:6–8. Hence, Brantigan discloses an
`implant that is both shaped and sized with regard to the disc space.
`Patent Owner argues that Brantigan discloses an implant “that is
`designed to sit within the apophyseal ring” and “designed to sit in the central
`region of adjacent vertebral bodies where bone tends to be more cancellous
`and vascular.” PO Resp. 36–37 (citing Ex. 1006, 2:15–16, Fig. 1; Ex. 2041,
`1520:2–16; Ex. 2039, 50:1–10; Ex. 2038 ¶ 110). Hence, Patent Owner
`argues that Brantigan fails to disclose an implant that includes (or overlaps)
`
`4 Patent Owner argues that “[c]ollateral 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, e.g., Dec.
`on Inst. 13.
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`the apophyseal ring of a vertebral body or extends beyond a central region of
`a vertebral body. As previously described, claim 17 recites an implant being
`sized to occupy substantially the full transverse width of the vertebral body.
`Patent Owner does not show that claim 17 also recites an implant being
`sized to extend onto the apophyseal ring of the vertebral body or an implant
`being sized to extend beyond a central region of a vertebral body. Nor does
`Patent Owner point to an explicit disclosure in the Specification regarding
`the length of the implant with respect to the alleged “apophyseal ring.” We,
`therefore, are not persuaded by Patent Owner’s contention.
`Patent Owner argues that Brantigan discloses an implant “conforming
`in shape and size with opposing hard end plates of vertebrae’” that does not
`“include the outer periphery (or apophyseal ring) of a vertebral body” or
`“the entire vertebral body.” PO Resp. 34 (citing Ex. 2038 ¶ 29). As an
`initial matter, claim 17 recites an implant being sized to occupy substantially
`the full transverse width of the vertebral body. Hence, claim 17 requires that
`the implant occupy “a length that is less than the full transverse width of the
`vertebral bodies by an insubstantial amount.” Dec. on Inst. 9. Patent Owner
`does not demonstrate that claim 17 requires that the implant includes “the
`entire vertebral body.”
`Also, as discussed above, Brantigan discloses that the implant is
`“sized to conform with the disc space between adjoining vertebrae.” Ex.
`1006, 4:6–7. We construe