NuVasive, Inc.v.Warsaw Orthopedic, Inc.

Patent Trials and Appeals Board

Jul 10, 2014

13306583 - (D) (P.T.A.B. Jul. 10, 2014)

Trials@uspto.gov Paper 62
571-272-7822 Date: July 10, 2014
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.

A. The ’997 Patent (Ex. 1002)2
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.

B. Illustrative Claim
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.

C. Cited Prior Art
The pending grounds of unpatentabililty in this inter partes review are
based on the following prior art:
Jacobson US 4,545,374 Oct. 8, 1985 (Ex. 1004)
Brantigan US 5,192,327 Mar. 9, 1993 (Ex. 1006)
Frey US 4,917,704 Apr. 17, 1990 (Ex. 1007)
Michelson ’247 US 5,015,247 May 14, 1991 (Ex. 1008)
Alcareu EP 0567424 Oct. 27, 1993 (Ex. 1009)

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”).

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
Jacobson, Leu, and
Michelson ’247
§103 1 and 8
Jacobson, Leu, and
Brantigan
§103 1 and 8
Jacobson, Leu, Michelson
’247, and Alacreu
§103 2–7
Jacobson, Leu, Brantigan,
and Frey
§103 2–7

E. Claim Interpretation
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), the length of the implant of Brantigan would have
included both the alleged “vertebral endplate” and the alleged “apophyseal
ring” because both of these alleged structures overlie the space between
adjacent vertebral bodies (i.e., the “disc space”).
Patent Owner argues that Brantigan “expressly teaches an implant that
is designed to sit within the apophyseal ring” as illustrated in Figure 10 of
Brantigan, which, according to Patent Owner, “shows the implant 11 sitting
well within the apophyseal ring.” PO Resp. 36 (citing Ex. 1006 at Fig. 10).
We note that Brantigan illustrates an implant within an intervertebral space
in Figure 10, however, Patent Owner does not show persuasively that
Brantigan “expressly teaches” that the implant illustrated in Figure 10 sits
“within the apophyseal ring.” For example, Brantigan does not appear to
label any structure within Figure 10 as the “apophyseal ring.” Nor does
Patent Owner point to a disclosure in the textual portion of Brantigan
indicating that the implant as illustrated in Figure 10 (or any other figure in
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Brantigan) sits “within the apophyseal ring.” Indeed, as previously
described, Brantigan appears to disclose the opposite (i.e., that the implant is
“sized to conform with the disc space”). We, therefore, agree with Petitioner
that one of ordinary skill in the art would not have understood that Brantigan
discloses or suggests that the implant must not extend into the disc space
encompassed by the apophyseal ring (not having been disclosed or
suggested by Brantigan).
Patent Owner argues that “a figure in Brantigan . . . was admittedly
drawn incorrectly.” PO Resp. 36 (citing Ex. 2041, 1516:13–25, 1517:6–12;
Ex. 2039, 44:5–14). In particular, Patent Owner argues that Figure 11 of
Brantigan allegedly contains discrepancies regarding the direction of
insertion of the implant into the intervertebral space. See, e.g., Ex. 2041,
1516:13–25. We are not persuaded by Patent Owner’s argument at least
because, even if Figure 11 discloses discrepancies regarding the direction of
insertion of the implant, Patent Owner does not show persuasively that any
such errors in Figure 11 sufficiently refute the prima facie case of
obviousness that it would have been obvious to one of ordinary skill in the
art to have provided an implant sized to occupy “substantially the full
transverse widths of the vertebral bodies” given Brantigan’s explicit
disclosure that the implant is “sized to conform with the disc space.”
Patent Owner argues that Brantigan discloses an implant that “can be
rotated or reversed and still fit the vertebrae.” PO Resp. 37 (citing Ex. 1006,
2:24–25; Ex. 2038 ¶ 113). Given that the implants of Brantigan are inserted
“to support and fuse with adjacent vertebrae” (Ex. 1006, 1:65–66), we agree
with Petitioner that one of ordinary skill in the art would have understood
not to remove an implant once already inserted because doing so would not
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have permitted the implant to have provided the support desired or to have
fused with adjacent vertebrae, as Brantigan discloses. Thus, we agree that
one of ordinary skill in the art would have understood that Brantigan
discloses that the implant of Brantigan may be selected to be inserted in any
desired orientation (i.e., “rotated or reversed” prior to insertion so that the
implant will “still fit the vertebrae”).
In any event, regardless of which construction of “rotated or reversed
and still fit the vertebrae” is used, as discussed previously, Brantigan
discloses that the implant is “sized to conform with the disc space,” which
one of ordinary skill in the art would have understood to mean sized to
occupy substantially the full transverse widths of the vertebral bodies for
reasons previously stated.
Patent Owner argues that Brantigan discloses “an anterior approach to
the spine,” as opposed to a lateral approach. PO Resp. 26. As previously
discussed, Jacobson discloses or suggests this feature. We need not
determine whether one of ordinary skill in the art would have understood
Brantigan to also disclose this feature.

Leu – “interbody intraspinal implant”
Patent Owner argues that Leu discloses a “graft conglomerate” that,
according to Patent Owner “is not a spinal fusion implant.” PO Resp. 47–48
(citing Ex. 2038 ¶¶ 89; 97–99). Claim 1 recites an “interbody intraspinal
implant.” Patent Owner’s declarant (Dr. Sachs) testifies that Leu discloses
that the “graft conglomerate” contains “impacted bone” and “soft cancellous
bone” that “is not a structural implant as claimed by the ’997 [patent].” Ex.
2038 ¶ 97. Hence, Patent Owner appears to argue that one of ordinary skill
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in the art would have understood that an “interbody intraspinal implant,” as
recited in claim 1, must not contain “impacted bone” or “soft cancellous
bone” such that the implant is not a “structural implant.”
Patent Owner does not demonstrate that claim 1 recites that the
“interbody intraspinal implant” must not contain “impacted bone” or “soft
cancellous bone.” Nor does Patent Owner indicate that the ’997 patent
specification discloses this explicit definition of the term. While Patent
Owner’s declarant (Dr. Sachs) testifies that “this graft conglomerate [of Leu]
is not a structural implant as claimed by the ’997 [patent],” Ex. 2038 ¶ 97,
Petitioner’s declarant (Dr. McAfee) testifies that “nothing in Leu’s
suggestion for the ‘porous apatite’ graft . . . required an ordinary spinal
surgeon . . . to limit his or her thoughts only to ‘bits of porous apatites’” and
that “spinal surgeons of ordinary skill understood that various non-bone
elements were inserted into the disc space as part of conventional interbody
fusion.” Ex. 1029 ¶ 57. Hence, even if one of ordinary skill in the art would
have understood that an “interbody interspinal implant,” as recited in claim
1, must have provided structural support and that a “graft conglomerate”
containing only “impacted bone” and “soft cancellous bone” would have
provided insufficient structural support to be characterized as an “interbody
intraspinal implant” (as Dr. Sachs testifies), we credit Dr. McAfee’s
testimony that one of ordinary skill in the art would have also understood
that “non-bone elements were inserted into the disc space as part of
conventional interbody fusion,” to provide sufficient structural support to be
classified as an “interbody interspinal implant.”
In any event, Dr. McAfee also testifies that it would have been
obvious to one of ordinary skill in the art to have “employ[ed] an implant
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structure having a size/structure suggested by Brantigan in the resulting
surgical method of Jacobson in view of Leu.” Ex. 1029 ¶ 57. Hence,
Petitioner and Dr. McAfee argue that Brantigan also discloses an “interbody
intraspinal implant,” as recited in claim 1. Patent Owner does not appear to
contest Petitioner’s contention.

“Elongated portion”
Patent Owner argues that Jacobson fails to disclose or suggest an
“elongated portion” because, according to Patent Owner, “[t]hese portions
[as disclosed by Jacobson] are not ‘positioned over’ adjacent vertebrae.” PO
Resp. 50. Patent Owner does not demonstrate that any one of claims 1–8
recites an “elongated portion.”

Jacobson, Leu, Brantigan - combinability
Patent Owner argues that it would not have been obvious to one of
ordinary skill in the art to have combined the teachings of Jacobson, Leu,
and Brantigan. PO Resp. 50–53. Jacobson discloses advancing instruments
laterally into the disc space to perform a “fusion” procedure. Ex. 1004, 5:1–
4, 6:11–13. Leu discloses fusion of the lumbar spine by introducing an
“interbody graft” into the disc space. Ex. 1005, p. 603. Brantigan, like Leu,
discloses “prosthetic implant devices” that are “suitable for . . . lateral
placement in any area of the spine.” Ex. 1006, 2:56–58. We agree with
Petitioner that the combination of the known element of performing a spinal
fusion procedure by laterally advancing instruments into the disc space
(Jacobson) with the known element of using an “interbody graft” in a spinal
fusion procedure (Leu and Brantigan) would have resulted in no more than
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the predictable and expected result of performing a spinal fusion procedure
(Jacobson) that includes inserting an implant into a disc space (Leu or
Brantigan). “The combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results.” KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398, 416 (2007).
Patent Owner argues that one of ordinary skill in the art would not
have combined the teachings of Jacobson with Leu because “the sequential
dilators [of Leu] would widen the perforation [caused by a needle puncture
to the patient’s intestines] without any warning to the surgeon.” PO Resp.
51. We are not persuaded by Patent Owner’s argument at least because none
of Jacobson or Leu supports the contention made.
Patent Owner also argues that it would not have been obvious to one
of ordinary skill in the art to have combined the teachings of Brantigan with
any of Jacobson or Leu because, according to Patent Owner, Brantigan
“teaches away from sizing an implant to rest on the apophyseal ring or be
sized to occupy substantially the full transverse width of adjacent vertebral
bodies.” PO Resp. 51–52, 55–56. This issue was discussed previously
above.
Patent Owner also argues that it would not have been obvious to one
of ordinary skill in the art to have combined the teachings of Brantigan with
any of Jacobson or Leu because the “cannulae disclosed by Jacobson and
Leu are too narrow to accommodate Brantigan’s implant,” that “a person of
ordinary skill in the art would not be able to insert [Brantigan’s] implant in
Jacobson’s [system],” and that “the shape of the Brantigan implant is not
conducive to insertion through a cannula or similar surgical instrument [as
disclosed by Jacobson or Leu].” PO Resp. 52. In other words, Patent
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Owner argues that the combination of Jacobson, Brantigan, and Leu would
not have been obvious to one of ordinary skill in the art because the prior art
systems are not physically combinable (i.e., Brantigan’s implant allegedly
cannot be physically combined with the cannula of either Jacobson or Leu).
“The test for obviousness is not whether the features of a secondary
reference may be bodily incorporated into the structure of the primary
reference . . . . Rather, the test is what the combined teachings of those
references would have suggested to those of ordinary skill in the art.” In re
Keller, 642 F.2d 413, 425 (CCPA 1981); see also In re Sneed, 710 F.2d
1544, 1550 (Fed. Cir. 1983) (“[I]t is not necessary that the inventions of the
references be physically combinable to render obvious the invention under
review.”). We are thus not persuaded by Patent Owner’s argument.

Secondary considerations
We recognize that evidence of secondary considerations must always
be considered en route to the determination of obviousness, but its existence
alone does not control the conclusion of obviousness. Richardson-Vicks v.
Upjohn Co., 122 F.3d 1476, 1483 (Fed. Cir. 1997). The weight given to
evidence of secondary considerations is dependent upon whether there is a
nexus between the merits of the claimed invention and the evidence offered.
Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1539 (Fed. Cir. 1983).

Commercial Success
Patent Owner argues non-obviousness based on alleged commercial
success of the claimed invention. PO Resp. 56–57. Patent Owner contends
that Petitioner’s product (i.e., the “XLIF procedure and CoRoent XL
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implants”) and Patent Owner’s product (i.e., the “DLIF procedure and
Clydesdale and Capstone L implants”) have “enjoyed tremendous
commercial success,” based on “100,000 spinal levels” having been treated
since 2003, sales of Petitioner’s product of “$250M from May 2004 to June
2010,” and sales of Patent Owner’s product of over “$50M over
approximately the same time period.” PO Resp. 56–57 (citing Ex. 2038
¶ 136; Ex. 2045, 47; Ex. 2046–2048).
Even assuming the sales figures quoted by Patent Owner for both
Petitioner’s product and Patent Owner’s product are correct, and assuming
that these sales figures represent “commercial success,” Patent Owner has
not demonstrated a sufficient nexus between the merits of the claimed
invention and the evidence offered. Patent Owner contends that “in order to
encourage surgeons to select its product, Petitioner touts the CoRoent XL
implant as having the patent features of the ’997 patent, such as a ‘large foot
print,’ ‘spans ring apophysis,’ and ‘maximizes fusion surface area.’” PO
Resp. 57 (citing Ex. 2049, 21). We note that Patent Owner does not show
that any of “large foot print,” “spans ring apophysis,” or “maximizes fusion
surface area” is recited in the claims of the ’997 patent. Not having
identified any specific features in the claims of the ’997 patent that form the
basis for the commercial success of Petitioner’s product, Patent Owner does
not show persuasively a nexus between the claimed invention and the
evidence proffered.
In addition, even assuming that these features are recited in the claims
of the ’997 patent, Patent Owner still does not demonstrate a sufficient nexus
between these specific alleged features and the evidence relied upon to
demonstrate commercial success (i.e., sales figures). Upon review of the
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marketing materials cited by Patent Owner, we observe that in addition to a
“large foot print,” “spans ring apophysis,” and “maximizes fusion surface
area,” the marketing materials also allege other benefits of the marketed
product such as “minimal soft tissue/muscle damage,” “reduced post-
operative morbidity,” “outpatient or 23 hr procedure,” “adequate exposure,”
“safe and reproducible,” and “meet or exceed traditional results.” Ex. 2049,
17. Patent Owner provides insufficient evidence to show which of these
alleged benefits of the marketed product (if any) would have resulted in (i.e.,
had a “nexus” to) the “commercial success” (i.e., sales revenue) alleged by
Patent Owner.

Industry Praise
Patent Owner argues non-obviousness based on “industry praise”
allegedly attributed to the claimed invention. PO Resp. 58-59. Industry
praise must also be linked to the patented invention. Power-One, Inc. v.
Artesyn Techs., Inc., 599 F.3d 1343, 1352 (Fed. Cir. 2010). Patent Owner
cites to “Back.com,” in which Dr. Richard Hynes states the benefits of the
DLIF [Direct Lateral Interbody Fusion] procedure are that “you’re
approaching the disc from the side rather than from the front or back.” Ex.
2050, p. 3. Petitioner has demonstrated that this feature (i.e., “direct lateral”
approach), as discussed above, is disclosed by Jacobson. Hence, the feature
that is allegedly praised was already present in the prior art. Under those
circumstances, any evidence of secondary considerations stems from what
was known in the prior art, so that there can be no nexus. Tokai Corp. v.
Easton Enters., Inc., 632 F.3d 1358, 1369 (Fed. Cir. 2011) (“If [secondary
considerations are] due to an element in the prior art, no nexus exists.”).
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Dr. Hynes alleges additional benefits of DLIF including “a very small,
1-2 cm incision,” no “big incisions,” no “cutting through muscles,” “patients
were in and out of the OR in less than an hour,” and there was “major
stabilization with no blood loss.” Ex. 2050, p. 3. Patent Owner does not
demonstrate sufficiently that any of these additional allegedly praiseworthy
features are recited in the ’997 patent claims. Hence, Patent Owner fails to
demonstrate sufficiently a nexus between the alleged praise and the claimed
invention.
Patent Owner also cites to Rose Mary Budge, “A New Solution,”
2004–2009, available at http://www.spinaldoc.com/
NuVasive_Spinal_Surgery.php. (“Budge,” Ex. 2051). Budge discloses the
procedure “involves side entry to the surgical [site] rather than from the back
or the front.” Ex. 2051 at 1. As previously described, this “praise,” to the
extent that this objective statement of the direction of entry to the surgical
site can be considered “praise” at all, was known in the prior art (e.g.,
Jacobson), so that there can be no nexus. Tokai Corp. v. Easton Enters.,
Inc., 632 F.3d 1358, 1369 (Fed. Cir. 2011).
Budge further states other benefits of the procedure, including that the
procedure is “less intimidating than the traditional methods,” “can
significantly lessen collateral damage,” causes “less tissue trauma, less
scarring, less blood loss and less post-operative discomfort.” Ex. 2051 at 1.
As previously described, Patent Owner does not show sufficiently a nexus
between any of these additional allegedly praiseworthy features and the
claimed invention because Patent Owner does not demonstrate that any of
these features are recited in the claims of the ’997 patent.
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Patent Owner also cites to PR Newswire, “26 Technologies Receive
2009 Spine Technology Awards,” 2009 (“PR Newswire,” Ex. 2052) as
demonstrating that “Petitioner’s XLIF was selected as a ‘Best New
Technology for 2009’ by Orthopedics This Week, an industry publication,
and won an award in the “Minimally Invasive Care’ category.” PO Resp.
58. Even assuming that the “XLIF” won an award as Patent Owner asserts,
Patent Owner does not show sufficiently that this award (or praise) had a
nexus to a claim feature of the ’997 patent (or which claim feature that might
be).
Patent Owner further argues that Dr. Michelson testifies that Mr.
Larry Boyd (presumably an officer at Sofamor Danek) had, for the first time,
“seen a lateral retroperitoneal [approach]” at some point in time. PO Resp.
59 (citing Ex. 2041, 195:24 – 196:2). According to Patent Owner, officers at
Sofamor Danek were “‘very excited’ about Dr. Michelson’s technology and
moved quickly to acquire it by signing a license agreement.” PO Resp. 59
(citing Ex. 2041, 68:7–15). Patent Owner does not provide sufficient
evidence explaining what features caused officers at Sofamor Danek to
become “very excited” or why the officers allegedly “moved quickly” to
sign a license agreement or how any alleged excitement or speed in the
signing of license agreements pertains to specific features recited in claims
1–8. Hence, Patent Owner does not show a sufficient nexus between the
claimed invention and the activities alleged to constitute “praise.”

Copying
Patent Owner argues non-obviousness based on alleged copying of the
claimed invention by competitors. PO Resp. 59–60. “[C]opying by a
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competitor may be a relevant consideration in the secondary factor analysis.”
Iron Grip Barbell Co., Inc. v. USA Sports, Inc., 392 F.3d 1317, 1325 (Fed.
Cir. 2004) (citing Vandenberg v. Dairy Equip. Co., 740 F.2d 1560, 1567
(Fed.Cir.1984). “[A] nexus between the copying and the novel aspects of
the claimed invention must exist for evidence of copying to be given
significant weight in an obviousness analysis.” Wm. Wrigley Jr. Co. v.
Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012) (internal
quotation omitted). Copying as objective evidence of nonobviousness
requires evidence of effort to replicate a specific product. Wyers v. Master
Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010); Iron Grip, 392 F.3d at
1325. Generally, evidence of alleged copying may be given little weight
when the copy is not identical to the product embodying the claimed
invention. See Pentec, Inc. v. Graphic Controls, Corp., 776 F.2d 309, 317
(Fed. Cir. 1985).
Patent Owner asserts that Petitioner “worked on an early lateral access
project called ‘ELIF,’ which stood for Extreme Lateral Interbody Fusion,”
trademarked the term “XLIF—for eXtreme Lateral Interbody Fusion” for the
product, and eventually “evolved into a profitable company.” PO Resp. 60
(citing Ex. 2041, 329:14–25, 434:2 – 435:14, 573:9 – 574:5, 979:19 – 24).
Patent Owner also states that “prototypes created by Dr. Michelson included
an implant with a 42 mm length, a distractor, outer sleeve, and other
instruments.” PO Resp. 60 (citing Ex. 2004). Patent Owner does not
demonstrate sufficiently that the alleged copy (i.e., “ELIF” or “XLIF”) is
identical to the product embodying the claimed invention. Therefore, little
weight is accorded to Patent Owner’s allegations of copying. To the extent
that Patent Owner argues that the “ELIF” or “XLIF” systems utilize implants
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measuring 42 mm in length, a distractor, outer sleeve, and “other
instruments,” Patent Owner does not demonstrate that such a system
embodies the claimed invention. For example, Patent Owner does not show
that any of the claims of the ’997 patent recite that the implant measures 42
mm in length and does not explain what the “other instruments” entail.
We have considered the evidence presented, but do not discern that it
adequately establishes that the pertinent products are replications of a
product that includes all the features of claim 1 of the ’997 patent. In any
event, even assuming that the noted “ELIF” or “XLIF” products do
incorporate all the features of claim 1, it is not the case that “every
competing product that arguably falls within the scope of a patent is
evidence of copying.” IronGrip, 392 F.3d at 1325. Rather, as noted above,
copying requires the “replication” of a specific product. Id.
Patent Owner does not provide additional arguments or evidence with
respect to claims 2–8. Petitioner has shown by a preponderance of the
evidence that claims 1 and 8 are unpatentable over the combination of
Jacobson, Leu, and Brantigan and that claims 2–7 are unpatentable over the
combination of Jacobson, Leu, Brantigan, and Frey.

B. Grounds Based at least in part on Jacobson, Leu, and Michelson ’247
Claim 1 recites the length of an implant being sized to occupy
substantially the full transverse width of the vertebral bodies of the two
adjacent vertebrae. Michelson ’247 discloses “an artificial fusion implant to
be placed into the intervertebral space left after the removal of a damaged
spinal disc” in which a drill is used that is “such a length that it can not
penetrate more than 28 millimeters beyond the end of the drill sleeve” so
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that “the implant . . . is able to be inserted only 28 millimeters.” Ex. 1008,
1:5–7; 9:40–42; 10:31–32. Michelson ’247 also discloses that “the
implant . . . is only 26 millimeters in length . . . [which] guarantees that the
implant . . . will be recessed into the vertebral bodies more than 2
millimeters and can not protrude into the spinal canal.” Ex. 1008, 10:32–36.
While Michelson ’247 discloses an implant that measures 26 millimeters in
length and is inserted into a drilled opening that is 28 millimeters in length,
Petitioner does not demonstrate sufficiently that Michelson ’247 also
discloses that the implant must occupy substantially the full transverse width
of the vertebral body (as recited in claim 1). For example, Michelson ’247
merely discloses a specific length of 26 millimeters for the length of the
implant (26 millimeters) and a specific length of a drilled opening (28
millimeters), but does not disclose the length of the implant (or opening) in
relation to the size of the vertebral body.
Michelson ’247 further discloses that the drill may be “varied and
made smaller for enhanced safety,” but does not appear to disclose
elongating the drill to a length greater than 28 millimeters. Ex. 1008, 9:42–
43. That further demonstrates that Michelson ’247 fails to disclose or
suggest sizing the implant to obtain the maximum sized implant with respect
to the size of the vertebral body. Instead, Michelson ’247 appears to suggest
using only smaller sized implants “for enhanced safety.”
Petitioner argues that Michelson ’247 discloses that the implant
“should extend longitudinally across the full disc space in the axial direction
of insertion.” Pet. 11. As Patent Owner points out, “there is nothing in the
written disclosure of Michelson ’247 that teaches a surgeon to size an
implant to span as much of the length as possible from an anterior to
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posterior direction.” PO Resp. 41 (citing Ex. 2039, 44:16–19; 45:6–16).
Petitioner does not point out where specifically Michelson ’247 discloses or
suggests this feature.
Petitioner argues that Patent Owner does not argue Michelson ’247
discloses an implant that would not rest on the apophyseal ring or that the
implant is designed to rest only on a spongy center part of the vertebrae and
that “the ’997 patent’s drill has the very same feature [as the drill disclosed
by Michelson ’247].” Pet. Reply 11. Even assuming Petitioner’s allegations
to be correct, Petitioner still does not demonstrate persuasively that
Michelson ’247 discloses or suggests an “implant being sized to occupy
substantially the full dimension of the vertebral body, as recited in claim 1.
Claims 2–8 depend from claim 1. Petitioner does not allege that any
of Jacobson, Leu, or Alacreu discloses or suggests the disputed feature.
Petitioner has not demonstrated by a preponderance of the evidence that that
claims 1-8 would have been obvious over the combination of Jacobson, Leu,
and Michelson ’247 (and Alacreu).

C. Motion to Exclude
In its Motion to Exclude, Patent Owner seeks to exclude the following
documents:
1. Declaration of Dr. Paul McAfee (“McAfee Declaration,” Ex. 1001,
54–85);
2. Affidavit of Henry Vernon Crock (Ex. 1020–1026);
3. Second Declaration of Dr. Paul McAfee (Ex. 1029 ¶¶ 4, 7, 9, 10,
37–39, 43–45, 48, and 49);
4. Declaration of Dr. Robert E. Jacobson (“Jacobson Declaration,”
Ex. 1030 ¶¶ 4–6, 8, and 10);
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5. Declaration of Patrick Miles (“Miles Declaration,” Ex. 1032 ¶ 9);
6. William A Friedman, Percutaneous Discectomy: An Alternative to
Chemonucleolysis?, NEUROSURGERY, Vol. 13, No. 5 (1983)
(“Friedman Article,” Ex. 1036);
7. Steven L. Kanter and William A. Friedman Percutaneous
Discectomy: An Anatomical Study, NEUROSURGERY, Vol. 16, No. 2
(1985) (“Kanter Article,” Ex. 1037);
8. Medtronic Corporate Structure (Ex. 1046);
9. Gregory M. Malham, et al., Clinical Outcome and Fusion Rates
after the First 30 Extreme Lateral Interbody Fusions, THE
SCIENTIFIC WORLD JOURNAL (2012) (“Malham Article,” Ex. 1049);
10. Armen R. Deukmedjian, “Bowel and Vascular Injury Following
13,000 Lateral Interbody Fusions,” SMISS 2013 ANNUAL
CONFERENCE (“Deukmedjian Article,” Ex. 1050); and
11. Paul C. McAfee, et al., Minimally Invasive Anterior
Retroperitoneal Approach to the Lumbar Spine, SPINE, Vol. 23,
No. 13 (1998) (“McAfee Article,” Ex. 1067).
For the reasons discussed below, the motion is dismissed.

Second Declaration of Dr. Paul McAfee – Ex. 1029 ¶ 38
Patent Owner alleges that the Second Declaration of Dr. Paul McAfee
(Ex. 1029 ¶ 38) should be excluded because, according to Patent Owner,
“Dr. McAfee wrongly relies on Dr. Jacobson’s declaration (Exhibit 1030)
about the alleged surgeries he performed prior to 1995,” that “Dr. McAfee
wrongly relies on the Crock Affidavit (Exhibit 1014) in paragraphs 7 and 9
of his second declaration about the surgeries Dr. Crock allegedly performed
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prior to 1995,” which, according to Patent Owner, “are not relevant to
whether the challenged claims are unpatentable in light of the prior art
patents and printed publications in the instituted claims.” Paper 50 at 6.
The Second Declaration of Dr. Paul McAfee, however, is not relied
upon for any alleged surgeries performed by Dr. Crock or Dr. Jacobson prior
to 1995 (or at any other time). Rather, the Second Declaration of Dr. Paul
McAfee is relied upon to support what one of ordinary skill in the art would
have understood based on Figure 6 of the ’997 patent at the time of the
invention (see above). Ex. 1029 ¶ 38. Thus, we are not persuaded that the
Second Declaration of Dr. Paul McAfee (at ¶ 38) should be excluded.

Jacobson Declaration – Ex. 1030 ¶ 5
Patent Owner moves to exclude the Jacobson Declaration (Ex. 1030
¶ 5) based on various bases. Patent Owner alleges that the Jacobson
Declaration (Ex. 1030 ¶ 5) “include[s] what Dr. Jacobson was allegedly
doing prior [to] 1995, not what the Jacobson ’374 reference discloses to a
person of ordinary skill in the art.” Paper 50, 9–10.
The Jacobson Declaration (Ex. 1030 ¶ 5) is relied upon to ascertain
what one of ordinary skill in the art would have understood by the term
“lateral” and “direct lateral” at the time of the invention (see above) and is
not relied upon for any procedures Dr. Jacobson may or may not have been
alleged to have performed prior to 1995. Thus, we are not persuaded that
the Jacobson Declaration (at ¶ 5) should be excluded.

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Other Evidence
As previously described, Patent Owner moves to exclude other
evidence, none of which was relied upon by the Board. Therefore, Patent
Owner’s motion to exclude is moot with respect to the other evidence.

ORDER
Petitioner has demonstrated, by a preponderance of the evidence, that
claims 1 and 8 are unpatentable over Jacobson, Leu, and Brantigan under 35
U.S.C. § 103(a) and that claims 2–7 are unpatentable over Jacobson, Leu,
Brantigan, and Frey. Petitioner has not demonstrated, by a preponderance of
the evidence, that claims 1–8 are unpatentable over Jacobson, Leu, and
Michelson ’247 (and Alacreu) under 35 U.S.C. § 103(a).
In consideration of the foregoing, it is hereby:
ORDERED that claims 1–8 of the ’997 patent have been shown to be
unpatentable;
FURTHER ORDERED that Patent Owner’s Motion to Exclude is
dismissed.
This is a final decision. Parties to the proceeding seeking judicial
review of the decision must comply with the notice and service requirements
of 37 C.F.R. § 90.2.

IPR2013-00208
Patent 8,251,997 B2

36

PETITIONER:

Stephen Schaefer
Michael Hawkins
Todd Miller
Fish and Richardson PC
schaefer@fr.com
hawkins@fr.com
miller@fr.com

PATENT OWNER:

Thomas Martin
Wesley Meinerding
Nimalka Wickramaskera
Martin and Ferraro LLP
tmartin@martinferraro.com
wmeinerding@martinferraro.com
nwickramasekera.com