Paper 62
`
`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 IPR2013-00208
`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 1–8 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
`(Paper 16) (“Dec. on Inst.”).
`Subsequent to institution, Warsaw Orthopedic, Inc. (“Patent Owner”)
`filed a Patent Owner Response (Paper 29) (“PO Resp.”), and Petitioner filed
`a Reply (Paper 40) (“Pet. Reply”). Patent Owner also filed a Motion to
`Exclude Evidence. Paper 50. Petitioner filed an Opposition to Patent
`Owner’s Motion to Exclude (Paper 56) (“Opp.”), and Patent Owner filed a
`Reply (Paper 57) (“PO Reply”).. An Oral Hearing was conducted on June 5,
`2014, pursuant to a request for oral hearing filed by Petitioner (Paper 49)
`and Patent Owner (Paper 51).
`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 1–8 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.
`A spinal implant I is introduced through the extended outer sleeve and
`
`2 We refer to Ex. 1002 submitted by Petitioner and dated March 22, 2013.
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`installed across the disc space. Ex. 1002, 15:64–65; 16:24–26; Figs. 19, 22,
`23, 30, and 30A.
`
`
`
`
`Illustrative Claim
`B.
`Claim 1 is illustrative of the claimed subject matter of the ’997 patent,
`and is reproduced as follows:
`1. 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;
`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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`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.
`
`
`
`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
`Brantigan
`
`US 5,192,327 Mar. 9, 1993
`Frey
`
`US 4,917,704 Apr. 17, 1990
`Michelson ’247 US 5,015,247
`May 14, 1991
`Alcareu
`
`EP 0567424
`Oct. 27, 1993
`
`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)
`
`D.
`
`Pending Grounds of Unpatentability
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`This inter partes review involves the following asserted grounds of
`unpatentability:
`Reference(s)
`
`Basis
`
`Claims challenged
`
`§103
`
`§103
`
`§103
`
`§103
`
`Jacobson, Leu, and
`Michelson ’247
`Jacobson, Leu, and
`Brantigan
`Jacobson, Leu, Michelson
`’247, and Alacreu
`Jacobson, Leu, Brantigan,
`and Frey
`
`
`
`
`1 and 8
`
`1 and 8
`
`2–7
`
`2–7
`
`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 1)
`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. 10–11. 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.
`
`2.
`
`“non-bone interbody intraspinal implant” (claim 1)
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`Patent Owner argues that the term “non-bone interbody intraspinal
`implant” should be construed such that “the composition of the implant does
`not include any bone” because “the prefix ‘non’ is commonly understood to
`exclude the thing specified after the word.” PO Resp. 12–13, citing Ex.
`2038 ¶ 63. We agree that one of ordinary skill in the art would have
`understood that the prefix “non” indicates that the implant contains material
`that is not bone. Patent Owner does not show persuasively, however, that,
`under a broad but reasonable construction, one of ordinary skill in the art
`would have understood that it cannot contain any component derived from
`bone.
`Hence, we broadly, but reasonably, construe a “non-bone interbody
`instraspinal implant” as an implant that contains at least one component that
`does not contain bone.
`
`
`II. ANALYSIS
`A. Grounds Based at Least in Part on Jacobson, Leu, and Brantigan
`(Claims 1–8)
`Claim 1 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 1, 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
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`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.
`
`
`
`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
`
`
`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.
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`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 plain and common 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
`lateral,” as that term is presently construed in the instant proceedings. Also,
`we note that claim 1 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
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`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
`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
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`in claim 1 (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
`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.]”
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`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
`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 (“direct”) 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. 20.
`Patent Owner further contends that Jacobson discloses using “a 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
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`“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
`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 22 (citing Ex. 2038 ¶ 86). Based on this assumption, Patent Owner
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`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
`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
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`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
`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. 18.
`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
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`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
`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.
`
`
`Brantigan – “implant being sized to occupy substantially the
`full transverse widths of the vertebral bodies”4
`Claim 1 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
`
`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,
`e.g., Dec. on Inst. 12.
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`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, 38 (citing Ex. 1006, 2:15–16 and 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) the apophyseal ring of a vertebral body or extends beyond a
`central region of a vertebral body. As previously described, claim 1 recites
`an implant being sized to occupy substantially the full transverse width of
`the vertebral body. Patent Owner does not show that claim 1 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. 34–35 (citing Ex. 2038 ¶ 29). As an
`initial matter, claim 1 recites an implant being sized to occupy substantially
`the full transverse width of the vertebral body. Hence, claim 1 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
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`does not demonstrate that claim 1 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 the term “disc space” of claim 1 broadly but
`reasonably and in light of the Specification to include a space between
`adjacent vertebral bodies. We agree with Petitioner that it would have been
`obvious to one of ordinary skill in the art that an implant that is “sized to
`conform with the disc space,” as disclosed by Brantigan, would have
`occupied at least a length that is less than the full transverse width of the
`vertebral bodies by an insubstantial amount (i.e., occupying “substantially”
`the full transverse width). Otherwise, an implant that does not occupy
`“substantially” the full transverse width would not have been sized to
`conform to the disc space, in contrast to Brantigan’s disclosure that the
`implant is, in fact, sized to conform to the disc space.
`Dr. Sachs testifies that the vertebral body contains a “vertebral
`endplate ” that “is typically vascular,” an “apophyseal ring” “anatomically
`distinct from the vertebral endplate” and “almost entirely avascular” located
`“[t]oward the vertebral periphery,” and a “cortical rim” “distinct from the
`apophyseal ring” located “[a]t the very edge of the vertebral body.” Ex.
`2038 ¶ 29.
`While Dr. Sachs provides testimony on the anatomy of the
`intervertebral space and disc, Dr. Sachs does not appear to provide testimony
`supporting Patent Owner’s implied contention that one of ordinary skill in
`the art would have considered the term “occupying substantially the full
`transverse width of the vertebral body,” as recited in claim 1, to mean
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`“occupying no more than the width of the vertebral endplate” or “occupying
`(or not occupying) any portion of the apophyseal ring.” Hence, even
`assuming that Dr. Sachs’ characterization of the anatomy of the
`intervertebral disc space and vertebral bodies is correct, the testimony of Dr.
`Sachs provides insufficient evidence to refute the prima facie showing that it
`would have been obvious to one of ordinary skill in the art that an implant
`that is “sized to conform with the disc space,” as disclosed by Brantigan,
`would occupy “substantially” the disc space (i.e., including a length that is
`less than the full transverse width of the vertebral bodies by an insubstantial
`amount). In addition, even assuming claim 1 requires the length of the
`implant to overlap onto the “apophyseal ring” (claim 1 does not recite this
`requirement, however), t