Medtronic, Inc.v.NuVasive, Inc.

Patent Trial and Appeal Board

Apr 3, 2015

11789284 (P.T.A.B. Apr. 3, 2015)

Trials@uspto.gov Paper 49
Tel: 571-272-7822 Entered: April 5, 2015

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________

MEDTRONIC, INC.,
Petitioner,

v.
NUVASIVE, INC.,
Patent Owner.
_______________

Case IPR2014-00075
Patent 8,016,767 B2
_______________

Before FRANCISCO C. PRATS, SCOTT E. KAMHOLZ,
and DAVID C. McKONE, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

FINAL WRITTEN DECISION
35 U.S.C. § 318(a) and 37 C.F.R. § 42.73
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I. INTRODUCTION
A. Statement of the Case
Medtronic, Inc. (“Petitioner”) filed a Corrected Petition (Paper 6,
“Pet.”) requesting inter partes review of claims 1, 2, 4, 5, 10, 15, 17, and 18
of U.S. Patent 8,016,767 B2 (Ex. 1018, “the ’767 patent”). NuVasive, Inc.
(“Patent Owner”) filed a Preliminary Response (Paper 10, “Prelim. Resp.”).
We instituted trial based on the following ground of unpatentability:
References Basis Claims challenged
Branch,1 Obenchain,2 Blewett,3
and Koros ’4934
§ 103(a) 1, 2, 4, 5, 10, 15, 17,
and 18
Decision to Institute 22 (Paper 14, “Dec.”).
After trial was instituted, Patent Owner filed a Response (Paper 26,
“PO Resp.”) and Petitioner filed a Reply (Paper 31, “Reply”).
Petitioner filed a Motion to Exclude Evidence. Paper 34 (“Mot. to
Exclude”). Patent Owner filed an Opposition to the Motion to Exclude
Evidence. Paper 40 (“PO Opp.”). Petitioner filed a Reply to the Opposition
to the Motion to Exclude Evidence. Paper 43 (“Reply to Opp.”).
Patent Owner filed a Motion for Observations on Cross Examination.
Paper 38 (“PO Mot. Obs.”). Petitioner filed a Response to that Motion.
Paper 39 (“Resp. to Mot. Obs.”).

1 U.S. Patent No. 6,945,933 B2 (issued Sept. 20, 2005) (Ex. 1013).
2 U.S. Patent No. 5,313,962 (issued May 24, 1994) (Ex. 1003).
3 WO 03/005887 A2 (published Jan. 23, 2003 (filed July 11, 2002)) (Ex.
1014).
4 U.S. Patent No. 6,139,493 (issued Oct. 31, 2000) (Ex. 1006).
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Petitioner supported its Petition with Declarations by Robert G.
Watkins, IV, M.D. (“Watkins Decl.” (Ex. 1016)), Daniel Schwartz, Ph.D.
(“Schwartz Decl.” (Ex. 1017)), and David Hacker (“Hacker Decl.” (Ex.
1015)). Petitioner supported its Reply with a second Declaration by
Dr. Watkins (“Watkins Reply Decl.” (Ex. 1024)).
In support of its Response, Patent Owner relied on Declarations by
Frank Phillips, M.D. (“Phillips Decl.” (Ex. 2020)), Patrick Miles (“Miles
Decl.” (Ex. 2024)), and Theodore G. Obenchain, M.D. (“Obenchain Decl.”
(Ex. 2025)).
Oral Hearing was held on December 4, 2014, and the Hearing
Transcript (“Tr.”) has been entered in the record. Paper 48.
We have jurisdiction under 35 U.S.C. § 6(c). This Final Written
Decision is entered pursuant to 35 U.S.C. § 318(a). “In an inter partes
review instituted under this chapter, the petitioner shall have the burden of
proving a proposition of unpatentability by a preponderance of the
evidence.” 35 U.S.C. § 316(e).
We conclude that Petitioner has proved by a preponderance of the
evidence that claims 1, 2, 4, 5, 10, 15, 17, and 18 of the ʼ767 patent are
unpatentable. Petitioner’s Motion to Exclude Evidence is denied-in-part,
and dismissed-in-part as moot.
B. Related Cases
Patent Owner has asserted the ’767 patent against Petitioner in
Warsaw Orthopedic Inc. v. NuVasive Inc., Case No. 3:12-cv-02738-CAB-
MDD (S.D. Cal.). Pet. 1; Paper 9 at 2.
In Medtronic, Inc. v. NuVasive, Inc., IPR2014-00076, the Board
declined to institute inter partes review of claims 1, 2, 4, 5, 10, 15, 17, and
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18 of the ’767 patent based on grounds presented by Petitioner which
differed from the ground considered herein. IPR2014-00076, Paper 13.
Petitioner also has challenged a number of related patents in the following
proceedings in which trials were instituted: IPR2014-00034 (Patent
8,000,782), IPR2014-00073 (Patent 8,192,356), IPR2014-00074 (Patent
8,192,356), IPR2014-00081 (Patent 8,005,535), and IPR2014-00087 (Patent
8,005,535). These proceedings also were argued at the December 4, 2014,
oral hearing.
C. The ’767 Patent
The ’767 patent describes methods and apparatuses for accessing a
surgical target site, such as the lumbar spine, using minimally invasive
techniques. Ex. 1018, 1:34–2:60. In particular, the ’767 patent discloses a
surgical access system which includes “[1] a tissue distraction assembly and
[2] a tissue retraction assembly, both of which may be equipped with one or
more electrodes for use in detecting the existence of (and optionally the
distance and/or direction to) neural structures.” Id. at 3:11–15.
The tissue distraction assembly “is capable of, as an initial step,
distracting a region of tissue between the skin of the patient and the surgical
target site. The tissue retraction assembly is capable of, as a secondary step,
being introduced into this distracted region to thereby define and establish
the operative corridor.” Id. at 3:17–21. Once the operative corridor is
established, “any of a variety of surgical instruments, devices, or implants
may be passed through and/or manipulated within the operative corridor
depending upon the given surgical procedure.” Id. at 3:21–24.
Nerve detection is performed by a nerve monitoring system which
causes the electrodes on the tissue distraction/retraction instruments to emit
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electrical stimulation signals. Id. at 11:26–28. Depending on the location of
the instruments within the patient, the emitted signals cause muscle groups
to innervate, thus generating EMG (electromyographic) responses which can
be sensed by electrodes positioned on the patient’s muscles. See id. at
11:29–44.
The ’767 patent explains that, because it allows surgeons to safely and
reproducibly avoid nerves when forming a surgical operative corridor, the
disclosed system “may be particularly suited [in spinal surgery] for
establishing an operative corridor to an intervertebral target site in a postero-
lateral, trans-psoas fashion so as to avoid the bony posterior elements of the
spinal column.” Id. at 11:51–54.
Claim 1, the only independent claim Petitioner challenges in this
proceeding, reads as follows:
1. A method of accessing a surgical target site, comprising:

forming an initial distraction corridor using an elongate
stimulation instrument that is delivered to a lateral aspect of a
targeted spinal disc along a lateral, trans-psoas path to the
lumbar spine while a stimulation electrode of the elongate
stimulation instrument outputs an electrical stimulation signal
from a distal tip portion for nerve monitoring during delivery of
the elongate stimulation instrument along the lateral, trans-
psoas path to the lumbar spine;

activating a nerve monitoring system that controls the
electrical stimulation signal output from the stimulation
electrode of the elongate stimulation instrument during delivery
of the elongate stimulation instrument along the lateral, trans-
psoas path to the lumbar spine, the nerve monitoring system
detecting electromyographic (EMG) activity via a set of EMG
sensor electrodes in communication with muscle myotomes
associated with nerves in the vicinity of the targeted spinal disc;
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receiving nerve monitoring information from a video
display device of the nerve monitoring system that
contemporaneously displays: a numeric stimulation threshold
required to obtain the EMG activity in at least one of said leg
muscle myotomes, and a graphical representation of a patient,
wherein the video display device is operable to alert a user to at
least one of a presence and absence of a nerve near the elongate
stimulation instrument;

positioning an inner wire member in a disc annulus at the
lateral aspect of the targeted spinal disc, the inner wire member
being slidably disposed within a tubular distraction member of
the elongate stimulation instrument such that a distal tip of the
inner wire member is inserted along the lateral, trans-psoas path
and penetrates into the disc annulus at the lateral aspect of the
targeted spinal disc;

after forming the initial distraction corridor using the
elongate stimulation instrument, advancing a plurality of
sequential dilators to further dilate tissue along the lateral,
trans-psoas path to the lumbar spine while the inner wire
member remains engaged with the disc annulus at the lateral
aspect of the targeted spinal disc;

slidably advancing a plurality of retractor blades of a
retractor assembly simultaneously over an outer dilator of the
plurality of sequential dilators and toward the targeted spinal
disc along the lateral, trans-psoas path to the lumbar spine, the
retractor assembly including the plurality of retractor blades and
a handle assembly having pivotable arm portions that extend
generally perpendicularly relative to the plurality of retractor
blades, wherein the plurality of retractor blades are
simultaneously advanced over the outer dilator while in a
closed position, wherein the retractor blades are operable to
adjust to an opened position by rotation of a rotatable knob
element of the handle assembly that mates with teeth of a rack
member so as to move a first retractor blade relative to a second
retractor blade of the plurality of retractor blades, wherein each
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of the pivotable arm portions is arranged between the plurality
of retractor blades and the rotatable knob element and is
pivotable so as to reposition one arm portion relative to another;

removing the plurality of sequential dilators away from
the retractor assembly so that the plurality of retractor blades
form a lateral operative corridor to the lateral aspect of the
targeted spinal disc along the lateral, trans-psoas path to the
lumbar spine, and

removably engaging a fixation element with the first
retractor blade of the plurality of retractor blades so that a distal
portion of the fixation element extends from a distal end of the
first retractor blade and secures into a portion of the lumbar
spine; and

inserting an implant through the lateral operative corridor
formed by the plurality of retractor blades along the lateral,
trans-psoas path to the lumbar spine.

II. ANALYSIS
A. Claim Construction
The Board interprets claims using the “broadest reasonable
construction in light of the specification of the patent in which [they]
appear[].” 37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC, No.
2014-1301, 2015 WL 448667, at *5–*7 (Fed. Cir. Feb. 4, 2015). Under that
standard, claim terms are given their ordinary and customary meaning, as
would be understood by one of ordinary skill in the art in the context of the
entire disclosure. In re Translogic Tech. Inc., 504 F.3d 1249, 1257 (Fed.
Cir. 2007).
“Although an inventor is indeed free to define the specific terms used
to describe his or her invention, this must be done with reasonable clarity,
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deliberateness, and precision.” In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir.
1994).
Also, “while ‘the specification [should be used] to interpret the
meaning of a claim,’ courts must not ‘import[ ] limitations from the
specification into the claim.’ . . . [I]t is improper to ‘confin[e] the claims to
th[e] embodiments’ found in the specification . . . .” In re Trans Texas
Holdings Corp., 498 F.3d 1290, 1299 (Fed. Cir. 2007) (quoting Phillips v.
AWH Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005) (citations omitted,
bracketed text in internal quotes in original).
1. “positioning an inner wire member”
In the Institution Decision, we construed the positioning step of claim
1 of the ’767 patent (Ex. 1018, 13:24–31) to require positioning the inner
wire member in a disc annulus at the lateral aspect of a target spinal disc
while the wire member is slidably disposed within a tubular distraction
member of the elongate stimulation instrument. Dec. 8–9. Neither party
challenged this construction during the trial. We maintain it in light of the
record developed during trial.
2. “lateral, trans-psoas path to the lumbar spine”
Claim 1 of the ’767 patent requires delivery of an initial elongate
stimulation instrument, an inner wire member, a plurality of sequential tissue
dilators, and a plurality of retractor blades, along a “lateral, trans-psoas path
to the lumbar spine,” thereby forming an operative corridor to the lumbar
spine along that path, through which an implant is inserted. Ex. 1018,
12:63–14:3. Although we did not expressly construe the phrase “lateral,
trans-psoas path to the lumbar spine” in the Institution Decision, we do so
now, in view of the parties’ contentions discussed below.
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Petitioner contends that a “lateral approach refers to a path to the
spine starting from the side of the patient, and a trans-psoas path is a path in
which the surgical instrument(s) passes through the psoas muscle.” Pet. 7
(citing Ex. 1016 ¶ 20 (Watkins Decl.)). Patent Owner does not contend that
this construction is unreasonable, but notes that the Institution Decision
acknowledged the disclosure in the ’767 patent of allowing “surgeons to
safely and reproducibly avoid nerves when forming a later[al] trans-psoas
surgical corridor, which is particularly suited for lateral trans-psoas spinal
surgery.” PO Resp. 43 (citing Dec. 5).
We acknowledge again the ’767 patent’s disclosure that its teachings
allow safe and reproducible avoidance of nerves along a lateral trans-psoas
path in a fashion that avoids the bony posterior elements of the spinal
column. Ex. 1018, 11:51–54. Claim 1, however, does not require the
“trans-psoas path” to pass through any particular portion of the psoas
muscle, nor does the claim require any particular degree or extent of passage
through the psoas. Moreover, the ’767 patent does not expressly define
“trans-psoas path.” See also Tr. 39:12–40:1, 113:5–114:3 (conceding that
the claims are not limited to any particular approach through the psoas
muscle). Accordingly, we conclude that the broadest reasonable
construction, consistent with the ’767 patent specification, of “trans-psoas
path,” encompasses a path which passes through any portion of the psoas
muscle, regardless of the degree or extent of the passage.
As to the lateral approach of the trans-psoas path required by claim 1,
the ’767 patent refers to a “lateral or far lateral access path (so-called trans-
psoas approach) to the lumbar spine” (Ex. 1018, 2:37–38), but does not
expressly define “lateral.” Regarding the accepted meaning of the term,
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Patent Owner’s witness, Dr. Obenchain, testified that “[l]ateral would be
anything that’s basically lateral to an anterior puncture. I mean, again, you
get into anterolateral or lateral, but it’s a fairly broad basis as to what
‘lateral’ means.” Ex. 1039, 36:2–5 (Obenchain Deposition). Given
Dr. Obenchain’s qualifications (Ex. 2025, ¶¶ 1–4, Exhibit A), we credit his
testimony on this issue.
Accordingly, we conclude that the broadest reasonable construction,
consistent with the specification of the ’767 patent, of “lateral, trans-psoas
path to the lumbar spine,” encompasses a path, to the lumbar spine, which
passes through any portion of the psoas muscle, regardless of the portion,
degree, or extent of passage through the psoas, and which is lateral, to any
degree, as compared to an anterior puncture.
No other terms require express construction for purposes of this
Decision.
B. Obviousness of Claims 1, 2, 4, 5, 10, 15, 17, and 18 over Branch,
Obenchain, Blewett, and Koros ’493
1. Prior Art Evidence of Obviousness
Petitioner summarizes its position by contending that “the method of
claim 1 uses known minimally invasive spinal access instruments, in a
known path used in minimally invasive spinal surgery, with nerve
monitoring that was known for use with minimally invasive spinal access
instruments.” Pet. 51.
To support those contentions, Petitioner cites Branch as teaching a
process of accessing a surgical site on the spine, using a guidewire, dilators,
and retractor blades, deployed in a manner encompassed by the steps of
claim 1. Id. at 45–48. Petitioner cites Koros ’493 as evidence that a person
of ordinary skill in the art would have considered it obvious to equip
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Branch’s retractor blades with fixation screws, as also required by claim 1.
Id. at 49 (citing Ex. 1016 ¶¶ 51, 74 (Watkins Decl.)). Petitioner cites
Obenchain as evidence that the trans-psoas path to the lumbar spine required
by claim 1 was known to be a suitable surgical approach. Id. at 50.
Petitioner cites Blewett as evidence that an ordinarily skilled artisan would
have considered it obvious to equip the initial dilators used in Branch’s
methods with nerve-monitoring electrodes as part of an EMG monitoring
system, and to perform the nerve monitoring steps required by claim 1 using
those instruments. Id. at 50–51.
Patent Owner, in addition to the secondary considerations of
nonobviousness discussed below, argues that Petitioner’s contentions
regarding the prior art, as well as the testimony of Petitioner’s supporting
witnesses, are based on improper hindsight. PO Resp. 2–3, 34–36, 39–40,
50–52. Patent Owner argues also that the teachings in the cited references
would not have motivated an ordinarily skilled artisan to disregard the
conventional wisdom in the art at the time of the ’767 patent invention, that
the nerve rich portions of the psoas muscle should be avoided entirely when
performing lumbar spinal surgery. Id. at 44–52. Patent Owner argues,
moreover, that the cited prior art does not disclose or suggest a procedure
that produces, through the psoas muscle, an operative corridor of sufficient
size to introduce an implant into the disc space. Id. at 53–54.
As the Supreme Court has stated, when evaluating claims for
obviousness, “the scope and content of the prior art are to be determined;
differences between the prior art and the claims at issue are to be
ascertained; and the level of ordinary skill in the pertinent art resolved.”
KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406 (2007) (quoting Graham v.
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John Deere Co., 383 U.S. 1, 17–18 (1966)). Secondary considerations, if
present, also must be considered. See id.
As to the level of ordinary skill in the pertinent art, the parties, as
discussed below, challenge their opposing experts’ conclusions and
qualifications. Nonetheless, neither party asserts specifically that the
ultimate conclusion of obviousness turns on adoption of a particular level of
ordinary skill. In that regard, the parties’ experts advance slightly different
opinions as to the level of ordinary skill in the pertinent art. See Ex. 1016
¶ 11 (Watkins Decl.)); Ex. 2020 ¶ 17 (Phillips Decl.). Both experts,
nonetheless, agree generally that an ordinarily skilled artisan at the critical
time would have been an experienced spinal surgeon, or an experienced
engineer or professional involved in the implementation or design of
surgical instruments for use in spinal surgery, with significant access to
orthopedic or neurosurgeons. See id. When evaluating the parties’
contentions regarding the scope and content of the prior art, and the
differences between the prior art and the challenged claims, we take into
consideration both parties’ assertions regarding the level of ordinary skill.
We note also that the level of ordinary skill in the art may be evidenced by
the cited references. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed.
Cir. 2001).
Having reviewed the parties’ contentions and supporting evidence
regarding the scope and content of Branch, Obenchain, Blewett, and Koros
’493 as compared to the subject matter recited in claims 1, 2, 4, 5, 10, 15, 17,
and 18 of the ’767 patent, we determine that Petitioner has shown, based on
the teachings in the prior art, that an ordinarily skilled artisan would have
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been prompted to perform a process having all of the steps and features
required by those claims.
Specifically, as Petitioner discusses (Pet. 45–47), Branch describes a
minimally invasive spinal surgery procedure involving the formation of an
initial tissue distraction corridor using sequentially larger tissue dilators,
followed by insertion of retractor blades over the final dilator, as claim 1
requires. See Ex. 1013, 6:20–67. As Petitioner discusses (Pet. 47–49),
Branch discloses that its retractor blades may employ a knob/rack
arrangement, encompassed by claim 1, to separate the blades. Ex. 1013,
7:58–62, Fig. 7.
As Petitioner discusses (Pet. 46), Blewett describes electrode-
equipped tissue distracting elements similar to those described in Branch,
which may be used to access a spinal site, in a process that includes using a
wire to penetrate a spinal disc annulus, as required by claim 1’s inner wire
member positioning step:
An initial dilating cannula 26 is advanced towards the target
site, preferably after having been aligned using any number of
commercially available surgical guide frames. An obturator
(not shown) may be included inside the initial dilator 26 and
may similarly be equipped with one or more stimulating
electrodes. Once the proper location is achieved, the obturator
(not shown) may be removed and the K-wire 24 inserted down
the center of the initial dilating cannula 26 and docked to the
given surgical target site, such as the annulus of an
intervertebral disc. Cannulae of increasing diameter are then
guided over the previously installed cannula 26 until the desired
lumen is installed.

Ex. 1014, 9:18–10:2.
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As Petitioner discusses (Pet. 50–51), Blewett discloses “a system and
related methods for determining nerve proximity and nerve direction to
surgical instruments employed in accessing a surgical target site, as well as
monitoring the status or health (pathology) of a nerve or nerve root during
surgical procedures.” Ex. 1014, 2:28–31. Blewett discloses equipping
surgical instruments, including initial tissue dilating instruments, with
electrodes that allow a surgeon to detect and avoid nerves. Id. at 3.
Given Blewett’s teachings, Petitioner persuades us that an ordinarily
skilled artisan, creating initial access into a patient for spinal surgery, using
guidewires and a plurality of dilators as taught by Branch, would have been
prompted to equip the initial dilator with a nerve monitoring electrode, as
required by claim 1 of the ’767 patent, to allow the surgeon to avoid nerves.
Petitioner persuades us also that an ordinarily skilled artisan would
have been prompted to equip Branch’s retractor blades with a fixation
element, as claim 1 requires. Specifically, Koros ’493 discloses that, in a
system for providing spinal access similar to that described by Branch,
providing two fixation screws that extend distally from the retractor blades,
is “advantageous to provide stability and improve support for the distractor
system.” Ex. 1006, 6:57–58.
Lastly, as to the lateral, trans-psoas path to the lumbar spine required
by claim 1, while Obenchain focuses on approaches other than a trans-psoas
path, see Ex. 1003, 1:48–66, Obenchain discloses, nonetheless, that
minimally invasive surgery of the lumbar spine can use a lateral trans-psoas
approach:
If desired, the surgery may traverse through the psoas muscle.
Where the surgery site is between L-5 and S-1, the dissection is
preferably generally close to the midline between the iliac
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branches of the great vessels. Alternatively, for example, where
the patient has extensive abdominal adhesions, it may be
preferred to use a lateral puncture of the abdomen to avoid
bowel perforation, and entry into the disc space is lateral,
transversing the psoas muscle, or immediately in front of it.

Id. at 6:22–31. Accordingly, Petitioner persuades us that an ordinarily
skilled artisan would have considered that approach suitable for performing
surgery on the lumbar spine.
In sum, given the teachings of Branch, Obenchain, Blewett, and Koros
’493, Petitioner persuades us that an ordinarily skilled artisan would have
been prompted to perform a process having all of the steps and features of
claim 1 of the ’767 patent. Patent Owner’s arguments do not persuade us to
the contrary.
Patent Owner advances evidence, including the testimony of
Dr. Obenchain, the named inventor on the Obenchain reference, that
ordinarily skilled artisans avoided traversing the psoas muscle when
performing lumbar spinal surgery, for fear of causing nerve damage. PO
Resp. 5–7 (citing Ex. 2025 ¶¶ 7, 13–16, 21 (Obenchain Decl.); Ex. 2020
¶¶ 18–21, 45–47 (Phillips Decl.)). Accordingly, Patent Owner contends, the
Branch and Obenchain references would not have suggested using the lateral
trans-psoas path to the lumbar spine required by claim 1 of the ’767 patent,
because the conventional wisdom in the art at the critical time, as supported
by the testimony of Drs. Obenchain and Phillips, was to avoid the psoas
muscle unless traversing it was necessary. Id. at 44–47. Patent Owner notes
in particular that “Dr. Obenchain feels strongly that his patent[] does not
‘teach toward’ a transpsoas approach, but instead teaches away from that
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approach.” Id. at 45 (citing Ex. 2025 ¶ 7 (Obenchain Decl.); Ex. 2020 ¶ 60
(Phillips Decl.)).
“A reference does not teach away . . . if it merely expresses a general
preference for an alternative invention but does not ‘criticize, discredit, or
otherwise discourage’ investigation into the invention claimed.” DePuy
Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1327 (Fed.
Cir. 2009) (quoting In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004)).
In the instant case, as noted above, the Obenchain reference teaches
expressly the suitability of a lateral, psoas-traversing pathway when
performing minimally invasive surgery on the lumbar spine. Ex. 1003,
6:22–31 (“If desired, the surgery may traverse through the psoas muscle. . . .
[F]or example, where the patient has extensive abdominal adhesions, it may
be preferred to use a lateral puncture of the abdomen to avoid bowel
perforation, and entry into the disc space is lateral, transversing the psoas
muscle . . . .”) (emphasis added). Given this express teaching, Petitioner
persuades us (Reply 2, 13–14) that the Obenchain reference does not teach
away from the lateral trans-psoas pathway required by claim 1 of the ’767
patent.
We acknowledge Patent Owner’s assertions, and supporting
testimony, that, despite the teachings in the Obenchain reference, ordinarily
skilled artisans avoided the psoas muscle when performing lumbar spinal
surgery. We acknowledge also Patent Owner’s assertions and supporting
testimony that lateral approaches to the lumbar spine that simply involved
retracting the entire psoas muscle were known in the art. PO Resp. 54
(citing Ex. 2065; Ex. 2020 ¶ 46 (Phillips Decl.)). Patent Owner,
nonetheless, effectively concedes that the lateral trans-psoas pathway, taught
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expressly in the Obenchain reference, and required by claim 1 of the ’767
patent, was, at worst, an unpreferred rather than unsuitable approach in
lumbar spinal surgery, and was actually necessary in certain circumstances:
One of skill would have also understood that it is only in cases
where avoiding the psoas muscle entirely is not possible—such
as the infrequent case where there is scarring from a prior
surgery—that Obenchain suggests using a trans-psoas
approach. . . . But doing that was not the preferred approach; it
was simply done out of necessity when entirely avoiding the
psoas muscle using Obenchain’s preferred method was not
possible.

PO Resp. 46 (citing Ex. 2025 ¶ 14 (Obenchain Decl.)) (emphasis added).
It is well settled that “all disclosures of the prior art, including
unpreferred embodiments, must be considered.” Merck & Co. Inc. v.
Biocraft Laboratories Inc., 874 F.2d 804, 807 (Fed. Cir. 1989) (quoting In re
Lamberti, 545 F.2d 747, 750 (CCPA 1976)). Thus, the fact that ordinarily
skilled artisans might not have preferred the lateral trans-psoas approach
described in the Obenchain reference, and might have used it only
infrequently, does not undermine Obenchain’s suggestion of using that
approach, under the appropriate circumstances.
As to Patent Owner’s contention that the approach taught in the
Obenchain reference would have been understood by ordinarily skilled
artisans as traversing only the psoas’s most anterior fibers incidentally (PO
Resp. 46–47), we note that the reference’s express teaching of a lateral
approach traversing the psoas contains no such qualifying language. While
it might be true that ordinarily skilled artisans would have traversed only
certain portions of the psoas when following the teachings in the Obenchain
reference, claim 1 of the ’767 patent does not contain language requiring any
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particular portion or degree of psoas traversal, as Petitioner argues (Reply 3),
and as discussed above. Accordingly, Petitioner persuades us that claim 1
encompasses traversing the psoas to the degree suggested to ordinarily
skilled artisans by the Obenchain reference.
Patent Owner contends that Branch provided multiple alternative
approaches to the spine, which would have eliminated any concerns
regarding the bowel perforation the Obenchain reference sought to avoid
through use of the lateral trans-psoas pathway. PO Resp. 48. Thus, Patent
Owner contends, an ordinarily skilled artisan would not have abandoned the
approaches taught by Branch in favor of the lateral trans-psoas approach
taught in the Obenchain reference, which would have effectively increased
the chance of bowel perforation as compared to the approaches outlined in
Branch. Id.
We are not persuaded. We acknowledge Branch’s disclosure that its
instruments were useful in non-lateral surgical approaches to the spine. Ex.
1013, 2:46–50. Nonetheless, Patent Owner does not direct us to any specific
disclosure in Branch explaining which particular approach, lateral, non-
lateral, or otherwise, should be used when performing surgery on the lumbar
spine. In contrast, as discussed above, the Obenchain reference states
expressly that, when performing surgery on the lumbar spine, a lateral trans-
psoas pathway may be used. As also discussed above, Patent Owner
concedes that that pathway, though unpreferred, is appropriate, and even
necessary, under certain circumstances. Thus, we are not persuaded that
Branch offered, with specificity, alternative approaches to the lumbar spine
that an ordinarily skilled artisan would have selected in preference to the
Obenchain reference.
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Patent Owner contends that, given the conventional wisdom in the art,
only through hindsight would ordinarily skilled artisans would have thought
to use nerve monitoring to traverse the psoas muscle to create an initial
tissue distraction corridor for use in lumbar spinal surgery. PO Resp. 48–52;
see also id. at 34–36, 38–40 (contending that testimony of Drs. Watkins and
Schwartz is based on improper hindsight). Petitioner replies that Patent
Owner improperly considers the cited references in piecemeal fashion, and
that Patent Owner’s own admissions provide reasons for combining the
references as proposed in the Petitioner. Reply 12–15.
We find that Petitioner has the better position.
As discussed above, the Obenchain reference teaches expressly the
use of a lateral trans-psoas approach to the lumbar spine, and Patent Owner
concedes that that approach, though unpreferred, was needed in certain
circumstances. As noted above, Blewett describes equipping surgical
instruments, including initial tissue dilating instruments, with electrodes that
allow a surgeon to detect and avoid nerves, as well as monitoring the status
and health of a nerve or nerve root during surgical procedures. Ex. 1014, 2–
3. Blewett focuses its disclosure on spinal surgery (id. at 6), and in
particular describes positioning its detecting electrodes at locations that
allow monitoring of nerves associated with the lumbar spine. Id. at 9.
Given Blewett’s disclosure, we are not persuaded that an ordinarily
skilled artisan would have combined the cited references’ teachings only
through impermissible hindsight, or that the cited prior art fails to support
the testimony of Drs. Watkins and Schwartz. Rather, because Blewett
teaches that its nerve monitoring system was desirable when performing
spinal surgery potentially encountering nerve roots associated with the
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lumbar spine, Petitioner persuades us that Blewett would have prompted an
ordinarily skilled artisan, performing lumbar spinal surgery, to equip an
initial tissue distracting instrument with an electrode for use in a nerve-
monitoring system, as required by claim 1 of the ’767 patent, when using the
Obenchain reference’s lateral trans-psoas approach.
It may be true, as Patent Owner argues (PO Resp. 50), that Blewett
does not mention specifically the psoas muscle when discussing the potential
of nerve damage in spinal surgery. Nonetheless, that fact underscores
Blewett’s suggestion that, rather than being useful only in certain
circumstances, its nerve monitoring system was desirable, in general,
whenever performing spinal surgery, including lumbar spinal surgery. Thus,
although Patent Owner characterizes the dangers of traversing certain
portions of the psoas as only “relatively low nerve risk” (PO Resp. 5 (citing
Ex. 2025 ¶ 14 (Obenchain Decl.); Ex. 2020 ¶ 45 (Phillips Decl.))), given
Blewett’s suggestion that it was desirable to use its system whenever
performing spinal surgery, Petitioner persuades us that an ordinarily skilled
artisan, performing surgery on the lumbar spine, would have been prompted
to equip an initial tissue distracting implement with a nerve-detecting
electrode, as taught by Blewett and required by claim 1 of the ’767 patent,
when using the lateral trans-psoas approach taught in the Obenchain
reference.
Patent Owner argues that the cited prior art does not disclose or
suggest a procedure that produces, through the psoas muscle, an operative
corridor of sufficient size to introduce an implant into the disc space. Id. at
53–54. In particular, Patent Owner contends that the operative corridor of
10 millimeters described in the Obenchain reference is well suited for a
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discectomy procedure, but not a procedure in which an implant is inserted.
Id. at 53 (citing Ex. 2025 ¶¶ 13–15 (Obenchain Decl.); Ex. 2020 ¶¶ 45, 59–
65 (Phillips Decl.)). Patent Owner contends further that Petitioner failed to
advance evidence suggesting that an ordinarily skilled artisan applying
Obenchain’s teachings would have used Branch’s system to form an
operative corridor sufficiently large for an implant. Id. at 53–54.
We are not persuaded. We again acknowledge the testimony of Drs.
Obenchain and Phillips regarding their surgical experience and their
understanding that the psoas muscle was to be avoided. Ex. 2025 ¶¶ 13–15
(Obenchain Decl.); Ex. 2020 ¶¶ 45, 59–65 (Phillips Decl.). Patent Owner
fails to direct us, however, to any specific evidence credibly supporting its
assertion that the operative corridor described in the Obenchain reference
would have been unsuitable for insertion of an implant. Claim 1, moreover,
does not place any limitation on the size or type of the inserted implant.
Further, Dr. Watkins testifies that an ordinarily skilled artisan would have
had a reason to use the implants described in Branch, in the discectomy
procedure taught in the Obenchain reference, to maintain vertebral
positioning in the absence of the removed disc. Ex. 1016 ¶ 77 (Watkins
Decl.) (citing Ex. 1013, 2:31–37); id. ¶ 38. Accordingly, Petitioner
persuades us that an ordinarily skilled artisan had a reason to insert an
implant through an operative corridor formed through the psoas muscle
according to the Obenchain reference’s teachings.
In sum, having considered the prior art advanced by Petitioner in light
of Patent Owner’s arguments regarding the cited references’ teachings,
Petitioner persuades us, based on those teachings, that an ordinarily skilled
artisan would have been prompted to perform a process having all of the
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steps and features of claim 1 of the ’767 patent. As to claim 1’s dependent
claims 2, 4, 5, 10, 15, 17, and 18, Patent Owner does not direct us to any
deficiency in Petitioner’s contentions that the teachings in Branch,
Obenchain, Blewett, and Koros ’493 would have suggested a process having
the additional steps and features recited in those claims. We have analyzed
Petitioner’s evidence regarding those references as compared to claims 2, 4,
5, 10, 15, 17, and 18 (see Pet. 51, 58–60), and agree, based on this evidence,
that the prior art teaches each limitation of those claims. Petitioner
persuades us further that, based on the references’ teachings, an ordinarily
skilled artisan would have been prompted to prepare a system practicing all
of the steps and features required by those claims.
2. Secondary Considerations/Objective Indicia
Patent Owner contends that objective evidence shows that the claimed
process would not have been obvious to an ordinarily skilled artisan. PO
Resp. 7–9. In particular, Patent Owner contends that its surgical procedure
and system solved a long-felt need (id. at 9–14), overcame significant
skepticism (id. at 14–16), elicited significant praise and recognition among
practitioners in the art as being advantageous as compared to other lumbar
surgical techniques (id. at 16–26), experienced significant commercial
success (id. at 26–31), and was copied by competitors (id. at 31–34).
Petitioner replies that Patent Owner has failed to establish adequately
a nexus between the objective indicia advanced by Patent Owner and the
subject matter recited in the claims. Reply 1, 7–10. Moreover, Petitioner
contends, because the asserted benefits of Patent Owner’s commercial
embodiment “are tied to the extreme/direct lateral approach, to the exclusion
of other transpsoas approaches,” and because the claims of the ’767 patent
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are not limited to that particular approach, the asserted objective indicia of
nonobviousness are not commensurate in scope with the claimed subject
matter. Id. at 9.
Before we conclude whether the challenged claims would have been
obvious, in addition to the teachings in the prior art, “[s]uch secondary
considerations as commercial success, long felt but unsolved needs, failure
of others, etc., might be utilized to give light to the circumstances
surrounding the origin of the subject matter sought to be patented.” Graham
v. John Deere, 383 U.S. at 17–18. Such objective indicia of nonobviousness
must be considered “as part of all the evidence, not just when the
decisionmaker remains in doubt after reviewing the art.” Eurand, Inc. v.
Mylan Pharm. Inc. (In re Cyclobenzaprine Hydrochloride Extended–Release
Capsule Patent Litig.), 676 F.3d 1063, 1076–77 (Fed. Cir. 2012) (citation
omitted).
Although Petitioner bears the ultimate burden of persuasion under
35 U.S.C. § 316(e), “[f]or objective evidence to be accorded substantial
weight, its proponent [Patent Owner] must establish a nexus between the
evidence and the merits of the claimed invention.” In re GPAC Inc., 57 F.3d
1573, 1580 (Fed. Cir. 1995). In particular, the objective indicia “must be
tied to the novel elements of the claim at issue” and must “‘be reasonably
commensurate with the scope of the claims.’” Institut Pasteur & Universite
Pierre Et Marie Curie v. Focarino, 738 F.3d 1337, 1347 (Fed. Cir. 2013)
(quoting Rambus Inc. v. Rea, 731 F.3d 1248, 1257 (Fed. Cir. 2013)).
In the instant case, Petitioner persuades us that the evidence of
secondary considerations is not entitled to substantial weight, because Patent
Owner has not established a sufficient nexus between the claimed subject
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matter and that evidence. Petitioner persuades us also that the evidence of
secondary considerations is not reasonably commensurate in scope with the
claimed subject matter.
In asserting that the claimed surgical system solved a long-felt need,
Patent Owner focuses its contentions on an alleged need for a lateral, trans-
psoas pathway. PO Resp. 9–12. That a vast majority of prior art
practitioners might have preferred anterior or posterior approaches to the
lumbar spine rather than a lateral psoas-traversing approach (id. at 9–11)
does not persuade us, however, that there existed a long-felt unresolved need
for the lateral trans-psoas pathway.
To the contrary, the existence of alternative approaches to the lumbar
spine supports a finding that the need for a suitable approach to the lumbar
spine had been resolved. That those alternative approaches may have
presented their own difficulties does not persuade us that there was a long-
felt need for the lateral trans-psoas pathway, absent evidence that
widespread efforts by ordinarily skilled artisans had failed in that approach.
See Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1325 (Fed.
Cir. 2004) (“[T]he mere passage of time without the claimed invention is not
evidence of nonobviousness.”) (citation omitted); see also In re Allen, 324
F.2d 993, 997 (CCPA 1963) (An allegation of a long-felt but unsolved
problem in the art “is not evidence of unobviousness unless it is shown . . .
that the widespread efforts of skilled workers having knowledge of the prior
art had failed to find a solution to the problem.”). In the instant case,
although Patent Owner directs us to evidence that practitioners attempted to
develop a lateral trans-psoas approach, Patent Owner concedes that those
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efforts were not widespread, but instead involved no more than “a small
handful of patients.” PO Resp. 12.
Patent Owner focuses on its “XLIF” (“eXtreme Lateral Interbody
Fusion”) system in contending that the claimed process allowed surgeons to
safely and reproducibly traverse the psoas muscle to access the lumbar
spine. Id. at 1, 12–14. The “XLIF procedure and systems” are described in
Exhibit 2028. Id. at 13. Patent Owner contends that Dr. Phillips— “a board
certified orthopaedic surgeon—compared XLIF to the independent claim of
the ’767 patent . . . [and] concluded that the XLIF procedure and systems
embody at least the independent claims of the ’767 patent.” Id. at 14 (citing
Ex. 2020 ¶¶ 22–23, 27, Attachment D (Phillips Decl.)).
We acknowledge that Dr. Phillips’s Declaration includes a chart
mapping the features of claim 1 of the ’767 patent to various disclosures in
Exhibit 2028. See Ex. 2020, 148–166 (Attachment D). None of this
explanation appears in Patent Owner’s Response, however. Nor does Patent
Owner’s Response include any other specific discussion of how the features
of XLIF correspond to the limitations in claim 1, or any of the other
challenged claims. Accordingly, we conclude that Patent Owner’s Response
improperly incorporates by reference these arguments from the Phillips
Declaration into the Response. See 37 C.F.R. § 42.6(a)(3) (“Arguments
must not be incorporated by reference from one document into another
document.”).5

5 Also in contravention of 37 C.F.R. § 42.6(a)(3), Patent Owner seeks to
incorporate by reference, into its Response, the arguments made in its
Preliminary Response. PO Resp. 54.
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Even disregarding the procedural infirmities in Patent Owner’s
Response, however, Petitioner persuades us that Patent Owner has not
established a sufficient nexus between the claimed subject matter and the
objective evidence of nonobviousness. Petitioner persuades us also that the
evidence of secondary considerations is not reasonably commensurate in
scope with the claimed subject matter.
In its arguments regarding initial skepticism, the evidence advanced
by Patent Owner is directed to the contention that ordinarily skilled
practitioners did not believe that the lumbar spine could be accessed safely
using the lateral trans-psoas approach employed in the XLIF procedure. PO
Resp. 14–16 (citing Ex. 2020 ¶¶ 28–33 (Phillips Decl.), Ex. 2024 ¶¶ 12–15
(Miles Decl.), Ex. 2025 ¶¶ 14–15, 21 (Obenchain Decl.)). Patent Owner’s
evidence of industry praise, as well as improved patient outcomes, focuses
similarly on the use of the XLIF technique in a lateral trans-psoas approach.
PO Resp. 16–26.
As Petitioner contends (Reply 3), and Patent Owner acknowledges,
the XLIF procedure “approaches the spine with sequential dilators
orthogonal to the disc space in a true lateral position.” PO Resp. 13 (citing
Ex. 2030, S370). Indeed, evidence advanced by Patent Owner explains that
the XLIF procedure uses “a 90° off-midline or direct lateral approach,” and
advises that it is “imperative that the approach be directly lateral to the
operative level.” Ex. 2043, 28.
In contrast, as Petitioner contends (Reply 3), and as discussed above,
claim 1 of the ’767 patent is not limited to the particular approach used in
the XLIF procedure, but instead encompasses any psoas-traversing approach
that is lateral to the midline to any degree. As discussed above also, Patent
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Owner acknowledges that the purportedly unpreferred lateral trans-psoas
approach taught in the Obenchain reference, and encompassed by claim 1,
was known to present only “relatively low nerve risk.” PO Resp. 5 (citing
Ex. 2025 ¶ 14 (Obenchain Decl.), Ex. 2020 ¶ 45 (Phillips Decl.)); see also
id. at 46–47 (asserting that traversing psoas according to teachings of
Obenchain reference was done only “out of necessity” and that psoas “would
have only been incidentally traversed at its most anterior fibers”). Thus,
even assuming for argument’s sake that ordinarily skilled artisans were
skeptical of the particular approach used in the XLIF procedure, claim 1 of
the ’767 patent is not limited to that approach, and instead encompasses
other lateral trans-psoas approaches to the lumbar spine, including
approaches that Patent Owner acknowledges were known to present
relatively minimal risk of nerve damage, and for which Patent Owner has
advanced no persuasive evidence of skepticism. Similarly, because it is not
limited to the surgical approach used in the XLIF procedure, claim 1
encompasses lateral trans-psoas surgical approaches Patent Owner
acknowledges were known in the art, but for which Patent Owner advances
no persuasive evidence as to improved patient outcomes and industry praise.
Accordingly, Petitioner persuades us that the evidence of skepticism,
improved patient outcomes, and industry praise is not commensurate in
scope with the claimed subject matter.
Further, as Petitioner argues (Reply 7–10), Patent Owner
acknowledges that a key aspect to the acceptability and success of the XLIF
technique is its directional nerve monitoring system, which allowed safe
navigation of the psoas. See PO Resp. 17 (“[T]he NeuroVision nerve
monitoring system . . . along with [Patent Owner] NuVasive’s techniques
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and other instruments, were the linchpin to safety and reproducibility.”), id.
at 18 (“XLIF . . . uses real-time directional neuromonitoring to ensure a safe
passage through the psoas muscle, avoiding the nerves of the lumbar
plexus.”) (emphasis removed), id. at 19 (“It is safe and reproducible with
few complications due to the use of automated neuromonitoring
(NeuroVision®).”) (emphasis removed).
Claim 1 of the ’767 patent, however, does not recite positively the use
of directional nerve monitoring, but instead recites only that its system’s
display device is “operable to alert a user to at least one of a presence and
absence of a nerve near the elongate stimulation instrument.” Ex. 1018,
13:21–23. Patent Owner does not explain how detecting the presence or
absence of a nerve accomplishes directional nerve monitoring. Patent
Owner, moreover, does not explain which features of claim 1 correspond to
the directional nerve monitoring employed in XLIF, which it acknowledges
contributes significantly to XLIF’s asserted success.
Patent Owner acknowledges also that the XLIF procedure uses three
dilators, each of which includes a stimulation electrode, and we note that at
least one of the retractor blades is equipped also for use with the nerve
detection system. Ex. 2020, 152, 158 (Phillips Decl., Attachment D); Ex.
2028, 8, 16, 17, 19.6 In contrast, claim 1 of the ’767 patent requires only the
initial tissue-distracting instrument to emit a nerve-detecting stimulation
signal. Ex. 1018, 12:63–14:3. Patent Owner does not advance any specific
credible evidence explaining whether a system having only a single initial

6 In citing to Exhibit 2028, we cite to the page numbers at the bottom center
of each page.
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tissue distracting element capable of detecting nerve presence or absence, as
recited in claim 1, would elicit the same praise or produce the same patient
outcomes as asserted for XLIF, in which each of the tissue-distracting
dilators and at least one retractor blade is part of the nerve monitoring
system. Accordingly, Petitioner persuades us that the XLIF system includes
a number of important features, which Patent Owner concedes contribute
significantly to any praise that may have been elicited, but which are not
recited in claim 1 of the ’767 patent. Petitioner persuades us also, therefore,
that Patent Owner has not established a nexus between the features of the
XLIF procedure and system which are asserted to have elicited praise, and
the elements of the sole claim for which Patent Owner presents specific
argument as to secondary considerations. See Ex. 2020, 148–166 (Phillips
Decl. Attachment D) (comparing XLIF (Ex. 2028) to claim 1 of the ’767
patent).
As to commercial success, Patent Owner contends that the growth in
its revenue, from about $38 million in 2004 to about $685 million in 2013, is
a direct result of XLIF, which was introduced in 2003. PO Resp. 27–28.
Patent Owner contends that XLIF created the lateral spine fusion market,
which it held exclusively until Petitioner’s entry into the market in 2006. Id.
To support its contentions regarding commercial success, Patent Owner
relies (PO Resp. 28–30) on the Declaration of its company executive Patrick
Miles (Ex. 2024 ¶ 1), its own internal report (Ex. 2040), as well as market
research reports from financial analysts (Ex. 2041 (www.idataresearch.net));
Ex. 2056 (J.P. Morgan); Ex. 2058 (Canaccord Genuity); Ex. 2059 (Caris &
Co)).
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Patent Owner summarizes its commercial success contentions as
follows:
As the evidence shows, XLIF’s commercial success (and
by extension [Patent Owner] NuVasive’s) is a direct result of
the novel combination of the minimally invasive nerve
monitoring enabled distractor(s)/dilator(s) and working corridor
instrument (retractor) (also optionally nerve monitoring
enabled) with NuVasive’s nerve monitoring system to safely
and reproducibly perform a lateral transpsoas approach to the
lumbar spine as claimed by the ’767 patent. . . . Not only is this
technology key to XLIF, but it is key to creating an entirely
new market for fusion.

PO Resp. 30–31 (citing Ex. 2024 ¶¶ 24–29 (Miles Decl.)).
Petitioner persuades us (Reply 4, 7–11), that Patent Owner has not
explained with adequate specificity the nexus between its assertions of
commercial success and the claimed subject matter.
Similar to the discussion above, Patent Owner acknowledges that the
nerve monitoring techniques employed in the XLIF system are critical to the
asserted commercial success of the system. See PO Resp. 28 (XLIF “makes
use of NuVasive’s proprietary NeuroVision neuromonitoring software to
protect nerve bodies”) (citing Ex. 2041), id. at 29 (navigating around key
nerves facilitated “through a proprietary technology (the foundation of the
company, in fact) called NeuroVision”) (citing Ex. 2056 (emphasis
removed)), id. at 29–30 (“The critical component obviously lies within its
NeuroVision offering and its MaXcess retractor system.”) (citing Ex. 2058
(emphasis removed)), id. at 30 (“Despite the obvious advantages of the
lateral approach, it requires that the surgeon avoid the nerve roots on the
spine, which wasn’t practical until NUVA [Patent Owner] launched its Inter-
operative Nerve monitoring system.”) (emphasis removed). Patent Owner’s
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own Exhibit 20437 attests to the importance of the nerve-monitoring system
to XLIF:
It is impossible to overemphasize the importance of
reliable, timely monitoring of the neural elements as the
surgeon traverses the psoas. Visual identification of the lumbar
plexus is not possible, but the plexus can be protected by using
an automated electrophysiology technology. The NeuroVision
system, in detection mode, uses a patented hunting algorithm
that provides five pulses of increasing amplitude current per
second until a recording myotome has responded. Once the
maximum current level to elicit a response is achieved, the
current output will stabilize at this level.

Ex. 2043, 28–29.
Thus, in addition to the strict adherence to the direct lateral 90° degree
approach, directional nerve monitoring, and use of nerve-detecting
electrodes on each of the tissue-distracting dilators, discussed above, Patent
Owner acknowledges that XLIF includes a proprietary software-driven
nerve monitoring system as a key feature of its asserted success. Patent
Owner does not, however, explain where that feature is recited in claim 1 of
the ’767 patent, or how claim 1 embodies that acknowledged key feature of
XLIF. Nor does Patent Owner present any specific argument explaining
how the features of the remaining challenged claims correspond to the
elements of the XLIF system.
Further, Petitioner directs us to evidence supporting its contention that
the commercial success asserted by Patent Owner resulted, at least in part,

7 W. Blake Rodgers et al., Experience and Early Results with a Minimally
Invasive Technique for Anterior Column Support Through eXtreme Lateral
Interbody Fusion (XLIF®), US MUSCULOSKELETAL REVIEW 2007, 28–32.
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from factors not associated with either the claims under challenge or the
techniques or hardware of XLIF. Specifically, as Petitioner points out
(Reply 1), a Form 10-K filed by Patent Owner with the United States
Securities and Exchange Commission for the fiscal year ending December
31, 2013, states the following:
To date, the majority of our revenues have been derived
from the sale of implants, biologics and disposables, and we
expect this trend to continue for the foreseeable future. We
generally loan our proprietary software-driven nerve monitoring
systems and surgical instrument sets at no cost to surgeons and
hospitals that purchase disposables and implants for use in
individual procedures. In addition, we place our proprietary
software-driven nerve monitoring systems, MaXcess® and
other MAS or cervical surgical instrument sets with hospitals
for an extended period at no up-front cost to them.

Ex. 2038, 69 (10-K filing by Patent Owner).
As the Federal Circuit has explained, “evidence of commercial
success alone is not sufficient to demonstrate nonobviousness of a claimed
invention.” In re DBC, 545 F.3d 1373, 1384 (Fed. Cir. 2008). Instead, “the
proponent must offer proof ‘that the sales were a direct result of the unique
characteristics of the claimed invention-as opposed to other economic and
commercial factors unrelated to the quality of the patented subject matter.’”
Id. (quoting In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)).
Here, while Patent Owner’s 2013 Form 10-K states that, to date, the
majority of its revenue had come from sales of implants, biologics, and
disposables (Ex. 2038, 69), claim 1 of the ’767 patent recites no details
regarding the implant inserted in the claimed procedure, and does not
expressly mention biologics or disposables. See Ex. 1018, 12:63–14:3.
Thus, Patent Owner acknowledges that the majority of its revenue had come
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from sales of implants, biologics, and disposables, but does not explain
persuasively how this is consistent with its contention that its commercial
success resulted directly from the elements of the XLIF system included
within claim 1. Also, that Patent Owner loaned its proprietary software-
driven nerve monitoring systems and surgical instruments, at no cost to
surgeons and hospitals that purchased its disposables and implants, supports
further Petitioner’s contention that Patent Owner failed to show that its
commercial success directly resulted from the unique characteristics of the
invention, as opposed to factors unrelated to the features of the claimed
invention.
As to Patent Owner’s contentions regarding market share, as
Petitioner discusses (Reply 5), Patent Owner asserts an initial 100% share of
the “Lateral IB Market” for calendar year 2004, which decreased to a 71%
share in 2008. PO Resp. 28 (citing Ex. 2003, 10). Patent Owner, however,
cites also a 2008 J.P. Morgan report stating that Patent Owner had “under
5% of the US lumbar fusion market, while the XLIF procedure can treat an
estimated 35% of all lumbar fusions.” Id. at 29 (citing Ex. 2056, 3).
Accordingly, the contradictions in Patent Owner’s assertions regarding
overall market penetration render that evidence unclear, and undercut its
probative value.
In sum, for the reasons provided, Petitioner persuades us that Patent
Owner has not established a sufficient nexus between the features of the
XLIF procedure and system, asserted as providing commercial success, and
the subject matter recited in claim 1 of the ’767 patent and its dependents.
For the reasons provided, Petitioner persuades us also that Patent Owner has
not established that claim 1 is commensurate in scope with the features of
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XLIF asserted to provide commercial success, and that Patent Owner did not
explain convincingly that XLIF held a significant portion of a relevant
market.
As to Patent Owner’s contentions regarding copying, we find that
Petitioner has the better position as well.
The Federal Circuit has explained that “[n]ot every competing product
that arguably falls within the scope of a patent is evidence of copying;
otherwise, ‘every infringement suit would automatically confirm the
nonobviousness of the patent.’” Wyers v. Master Lock Co., 616 F.3d 1231,
1246 (Fed. Cir. 2010) (quoting Iron Grip Barbell Co. v. USA Sports, Inc.,
392 F.3d at 1325). Rather,
copying requires evidence of efforts to replicate a specific
product, which may be demonstrated through internal company
documents, direct evidence such as disassembling a patented
prototype, photographing its features, and using the photograph
as a blueprint to build a replica, or access to the patented
product combined with substantial similarity to the patented
product.

Id.
In the instant case, Patent Owner directs us to a 2004 internal
document from Petitioner discussing XLIF’s direct lateral trans-psoas
approach, including its NeuroVision nerve monitoring system. PO Resp. 32
(citing Ex. 2086, 1, 3). Patent Owner asserts that Petitioner subsequently
introduced its own version of the XLIF system, “DLIF,” in 2006. Id. at 32–
33. Patent Owner cites the following passage from a 2011 Caris &
Company financial analysis report to show that DLIF system included the
features of the challenged claims of the ’356 patent:
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[Petitioner] MDT which is the dominant player in spine
(just under 40% market share) has offered its version of XLIF,
DLIF (Direct Lateral Interbody Fusion) for the past 3 years, and
it struggled to gain footing against XLIF. Part of the problem
was the lack [of] integration of a neuro monitoring system, but
they are addressing now with a newly integrated system, though
our checks still indicate that it’s not quite on par with [Patent
Owner] NUVA offerings, it is competitive.

Id. at 33 (quoting Ex. 2059, 4). Although this discussion suggests that DLIF
may have a nerve monitoring system similar to XLIF, Patent Owner does not
direct us to any evidence that describes the specific components or
procedures of the DLIF system, nor does Patent Owner otherwise explain
with specificity why the particular features required by claim 1, or any of the
other challenged claims of the ’767 patent, are in the DLIF system.
Patent Owner cites the following passage from a 2008 J.P. Morgan
financial analysis report to show that other competitors also copied Patent
Owner’s XLIF system: “[n]early every competitor now offers a lateral
access and/or neuromonitoring system and while [Patent Owner] NuVasive
can lay claim to the superiority of Nuerovision [sic] and the sophistication
and experience of XLIF, Medtronic, Globus, Depuy, and others are all
fighting back.” Id. (quoting Ex. 2066, 1) (emphasis omitted). Again,
however, although this discussion suggests that Patent Owner’s competitors
may have nerve monitoring systems similar to XLIF, Patent Owner does not
direct us to any evidence that describes the specific components of its
competitors’ systems or the surgical steps performed, nor does Patent Owner
otherwise explain with specificity why the particular features required by
claim 1, or any of the other challenged claims of the ’767 patent, are in its
competitors’ systems.
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Accordingly, in the absence of evidence credibly demonstrating that
the products of Petitioner and other competitors of Patent Owner include the
features required by the challenged claims of the ’767 patent, we are not
persuaded that Patent Owner has provided an adequate basis to find that
Petitioner or Patent Owner’s other competitors copied the methods recited in
the challenged claims.
3. Conclusion of Obviousness
In sum, as discussed above, having considered the prior art advanced
by Petitioner in light of Patent Owner’s arguments regarding the cited
references’ teachings, Petitioner persuades us, based on the teachings in
Branch, Obenchain, Blewett, and Koros ’493, that an ordinarily skilled
artisan would have been prompted to perform a process having all of the
steps and features of claims 1, 2, 4, 5, 10, 15, 17, and 18 of the ’767 patent.
As also discussed above, having considered Patent Owner’s evidence and
arguments regarding objective indicia of nonobviousness, Petitioner
persuades us that Patent Owner’s evidence does not show a sufficient nexus
between the claimed subject matter and the objective indicia. Accordingly,
under these circumstances, taking into consideration the record as a whole,
we conclude that Petitioner has shown by a preponderance of the evidence
that an ordinarily skilled artisan would have considered the processes recited
in claims 1, 2, 4, 5, 10, 15, 17, and 18 obvious in view of Branch,
Obenchain, Blewett, and Koros ’493.
C. Petitioner’s Motion to Exclude Evidence
Petitioner moves to exclude as hearsay Exhibits 2033, 2035, and
2036, which are asserted to be printouts from websites of Dr. Burak Ozgur
and Dr. Jonathan R. Stieber, because neither Dr. Ozgur nor Dr. Stieber
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Patent 8,016,767 B2

37
provided testimony in this proceeding, and because Patent Owner’s attorney
admitted not knowing the doctors, but instead merely printed the exhibits
from the internet. Mot. to Exclude 1–2.
Patent Owner contends that Exhibits 2033, 2035, and 2036 are
presented for non-hearsay purposes, to show what was being said about
XLIF as praise and recognition by the industry, rather than the truth of the
matter asserted. PO Opp. 2–3.
We agree that Exhibits 2033, 2035, and 2036 are offered for non-
hearsay purposes. Therefore, we do not exclude them.
Petitioner moves to exclude as hearsay Exhibits 2039, 2041, 2056,
2058, 2059, and 2066, which are asserted to be financial industry documents
evidencing commercial success and praise. Mot. to Exclude 3. Petitioner
contends that these exhibits are not reliable because Patent Owner has
admitted that it has no knowledge of whether the authors of the documents
are skilled artisans. Id.
Patent Owner argues that these documents are introduced for non-
hearsay purposes, such as showing industry praise and the states of mind of
the documents’ authors, and that the credentials of the authors go to the
weight of the evidence, not its admissibility. PO Opp. 5–7.
We agree with Patent Owner that the Exhibits were presented for non-
hearsay purposes, and that the credentials of the authors go to the weight of
the evidence, not its admissibility. Accordingly, we deny the motion to
exclude Exhibits 2039, 2041, 2056, 2058, 2059, and 2066.
We dismiss Petitioner’s Motion to Exclude Exhibits 2034, 2042,
2051, 2062, and 2070–73 as moot, because we do not rely on those Exhibits.
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38
III. ORDER
For the reasons given, it is
It is ORDERED that claims 1, 2, 4, 5, 10, 15, 17, and 18 of the ’767
patent have been shown by a preponderance of the evidence to be
unpatentable under 35 U.S.C. § 103(a) as obvious over Branch, Obenchain,
Blewett, and Koros ’493;
FURTHER ORDERED that Petitioner’s Motion to Exclude is denied-
in-part, and dismissed-in-part as moot; and
FURTHER ORDERED that, because this is a final written decision,
parties to this proceeding seeking judicial review of our Decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

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Patent 8,016,767 B2

39
For PETITIONER:
Brian L. Klock
Justin J. Oliver
FITZPATRICK, CELLA, HARPER & SCINTO
SPINE-IPR@fchs.com

For PATENT OWNER:
Michael T. Rosato
Paul D. Tripodi II
WILSON SONSINI GOODRICH & ROSATI
MROSATO@WSGR.COM
PTRIPODI@WSGR.COM

Stephen R. Schaefer
Michael T. Hawkins
FISH & RICHARDSON P.C.
SCHAEFER@FR.COM
HAWKINS@FR.COM
IPR13958-0120IP1@FR.COM