Medtronic, Inc.v.NuVasive, Inc.

Patent Trial and Appeal Board

Apr 3, 2015

12423559 (P.T.A.B. Apr. 3, 2015)

Trials@uspto.gov Paper 44
Tel: 571-272-7822 Entered: April 3, 2015

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________
MEDTRONIC, INC.,
Petitioner,
v.
NUVASIVE, INC.,
Patent Owner.
_______________

Case IPR2014-00081
Patent 8,005,535 B2
_______________

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

McKONE, 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. Background
Medtronic, Inc. (“Petitioner”) filed a Corrected Petition (Paper 5,
“Pet.”) to institute an inter partes review of claims 1–12 of U.S. Patent
No. 8,005,535 B2 (Ex. 1013, “the ’535 patent”). NuVasive, Inc. (“Patent
Owner”) filed a Preliminary Response (Paper 9, “Prelim. Resp.”). Pursuant
to 35 U.S.C. § 314, in our Decision to Institute (Paper 10, “Dec.”), we
instituted this proceeding as to all of the challenged claims of the
’535 patent.
After the Decision to Institute, Patent Owner filed a Patent Owner
Response (Paper 21, “PO Resp.”), and Petitioner filed a Reply to the Patent
Owner Response (Paper 26, “Reply”).

B. Related Cases
Petitioner challenged the ’535 patent, based on different art, in
Medtronic, Inc. v. NuVasive, Inc., IPR2014-00087. Petitioner also
challenged Patent Owner’s U.S. Patent No. 8,000,782 B2 in Medtronic, Inc.
v. NuVasive, Inc., IPR2014-00034; U.S. Patent No. 8,192,356 B2 in
Medtronic, Inc. v. NuVasive, Inc., IPR2014-00073, and Medtronic, Inc. v.
NuVasive, Inc., IPR2014-00074; and U.S. Patent No. 8,016,767 B2 in
Medtronic, Inc. v. NuVasive, Inc., IPR2014-00075. A combined oral hearing
(Paper 43, “Tr.”) was held on December 4, 2014, to address the instant inter
partes review and the related inter partes reviews.

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C. References Relied Upon
Petitioner relies upon the following prior art references:
Ex. 1001 Obenchain US 5,195,541 Mar. 23, 1993
Ex. 1004 Foley US 5,902,231 May 11, 1999
Ex. 1005 Marino WO 00/38574 A1 July 6, 2000
Ex. 1006 Kelleher WO 01/37728 A1 May 31, 2001
Ex. 1007 Isley Michael R. Isley et al., Recent
Advances in Intraoperative
Neuromonitoring of Spinal Cord
Function: Pedicle Screw Stimulation
Techniques, vol. 37, no. 2 AM. J.
ELECTRONEURODIAGNOSTIC TECH.,
at 93–126 (June 1997)
Ex. 1009 NIM Guide MEDTRONIC XOMED SURGICAL
PRODUCTS, INC., NIM-RESPONSE,
NERVE INTEGRITY MONITOR,
INTRAOPERATIVE EMG MONITOR
USER’S GUIDE (2000)
Ex. 1010 Moed Berton R. Moed, et al., Evaluation of
Intraoperative Nerve-Monitoring
During Insertion of an Iliosacral
Implant in an Animal Model,
vol. 81-A, No. 11 THE JOURNAL OF
BONE AND JOINT SURGERY
1529–1537 (Nov. 1999)

D. The Asserted Grounds
We instituted this proceeding based on the grounds of unpatentability
set forth in the table below. Dec. 29.

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References Basis Claims challenged
Foley, Marino, Obenchain, and
NIM Guide
§ 103(a) 1–12
Foley, Marino, Obenchain, NIM
Guide, and Moed
§ 103(a) 6
Kelleher, Foley, and Obenchain § 103(a) 1–11
Kelleher, Foley, Obenchain, and
Isley
§ 103(a) 12
Kelleher, Foley, Obenchain, NIM
Guide, and Moed
§ 103(a) 6

E. The ’535 Patent
The ’535 patent generally relates to techniques employing medical
devices for spinal surgery. Ex. 1013, Abstract. Two aspects of the
techniques described in the ’535 patent include: (1) employing sequentially
dilating cannulas (e.g., Ex. 1013, Fig. 18) to open a working corridor to a
patient’s spine; and (2) detecting the proximity and direction of nerves as the
cannulas are inserted through the patient’s tissue (id. at 10:53–58).
Regarding the second aspect, a surgeon determines nerve proximity and
direction using a stimulation electrode, placed on the distal tip of a cannula
or a K-wire (guide wire), that depolarizes nerves that are in close proximity
to the electrode. Id. at 11:25–30. The depolarized nerve produces a
response in an innervated myotome at a different location in the patient’s
body that can be monitored with an electromyography (“EMG”) harness
positioned, for example, on the patient’s legs. Id. at 11:30–35. The EMG
harness and the stimulation electrode are coupled to a control unit with a
display that provides visual feedback to the surgeon. Id. at Fig. 2, 10:20–36.
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Upon detecting a nerve, the surgeon has the option of repositioning the K-
wire or cannula to avoid the nerve. Id. at 11:35–38.
The cannulas bluntly dissect the tissue between the patient’s skin and
the surgical target site. Id. at 11:9–14. The surgeon can use the cannulas to
form an operative corridor between the skin and an intervertebral target site
through the psoas muscle (a trans-psoas path). Id. 11:38–42. Figures 16–19
illustrate the sequential insertion of dilating cannulas of increasing
diameters. A surgeon first inserts a thin cannula 48, with a K-wire 46
disposed inside, through a patient’s body to a working site at a vertebra.
Id. at 19:60–20:2, Fig. 16. The cannula and/or the K-wire includes a
stimulation electrode 70 positioned at an angle relative to the longitudinal
axis of the K-wire and cannula. Id. at 20:2–12. The response to the
stimulation can be monitored using the EMG harness as the cannula is
rotated, allowing the surgeon to identify the proximity and direction of any
nerves that come close to the cannula. Id. at 20:12–23.
The surgeon inserts additional cannulas of increasing diameter
sequentially over the first cannula until a desired working diameter is
achieved. Id. at 20:31–35, Fig. 17. The surgeon then inserts a working
corridor over the widest cannula (Fig. 18) and removes the cannulas, leaving
the working corridor in the patient’s body (Fig. 19), establishing a corridor
in which the surgeon can operate. Id. at 20:40–47. The surgeon can perform
the nerve proximity testing as each of these devices is inserted into the
patient. Id. at 11:9–18, 20:48–52. After establishing an operative corridor,
the surgeon can perform surgical procedures on the patient’s spine, such as
installing a spinal fusion implant. Id. at 22:61–23:6.
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Claim 1, reproduced below, is illustrative of the claimed subject
matter:
1. A method of inserting a spinal implant through a
trans-psoas operative corridor to an intervertebral disc,
comprising:
mounting a plurality of EMG electrodes proximate
to selected leg muscles;
activating a control unit operable to provide a
stimulation signal and including a graphical
user interface to receive user input and to
display neuromuscular response information
in response to signals from the EMG
electrodes;
inserting an initial dilator cannula in a trans-psoas
path through bodily tissue toward a lateral
aspect of a spine while an elongate
stimulation instrument is disposed within an
inner lumen of the initial dilator cannula;
activating the elongate stimulation instrument to
deliver the stimulation signal proximate to a
distal end of the initial dilator cannula when
the initial dilator cannula is inserted into the
trans-psoas path toward the spine;
monitoring the neuromuscular response
information displayed by the control unit in
response to delivery of the stimulation signal
when the initial dilator cannula is inserted
into the trans-psoas path toward the spine;
advancing two or more sequential dilator cannulas
of increasing diameter in the trans-psoas
path toward the spine;
advancing a working corridor instrument over the
two or more sequential dilator cannulas in
the trans-psoas path toward the spine;
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establishing a trans-psoas operative corridor to an
intervertebral disc of the spine using the
working corridor instrument; and
delivering a spinal fusion implant through the
trans-psoas operative corridor toward the
spine.

II. ANALYSIS
A. Claim Construction
The Board interprets claims of an unexpired patent using the broadest
reasonable construction in light of the specification of the patent in which
they appear. See 37 C.F.R. § 42.100(b); In re Cuozzo Speed Techs., LLC,
778 F.3d 1271, 1279–81 (Fed. Cir. 2015). Claim terms generally 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. See In re
Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007).
In the Decision to Institute, we preliminarily construed “trans-psoas
path” to mean “a path in which the instrument passes through the psoas
muscle.” Dec. 8–9. We specifically rejected Patent Owner’s position that
the ’535 patent limits “trans-psoas approach” to an approach through the
middle or posterior portion of the psoas muscle. Id.
We also preliminarily construed “initial dilator cannula” to carry its
ordinary meaning. Id. at 9. We rejected Patent Owner’s argument that the
initial dilator cannula must be the particular structure that defines a path in
such a manner that sequential dilator cannulas are advanced in that same
path and a working corridor instrument is advanced over the sequential
dilator cannulas. Id.
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Petitioner and Patent Owner do not dispute these constructions in the
PO Response or Reply. In view of this, and upon consideration of the
complete record developed during this trial, we maintain these constructions.
Neither Petitioner nor Patent Owner identifies any additional terms
requiring construction. No other terms require express construction for
purposes of this Decision.

B. Effective Filing Date of the ’535 Patent
The ’535 patent claims the benefit of U.S. Provisional Application
No. 60/325,424 (Ex. 1014, “the ’424 provisional”), filed September 25,
2001. Ex. 1013, 1:14–17. In the Decision to Institute, we determined that
the challenged claims of the ’535 patent are not entitled to the benefit of the
’424 provisional’s filing date. Dec. 10–11. Patent Owner does not
challenge this determination in the PO Response. In view of this, and upon
consideration of the complete record developed during this trial, we maintain
this determination.

C. Petitioner’s Motion to Exclude
Petitioner moves to exclude Exhibits 2013, 2014, and 2016–18 as
irrelevant because Patent Owner does not cite to them in this trial. Mot. to
Exclude (Paper 29) 1–2. Rather, these are exhibits that were used in the
deposition of Dr. Robert G. Watkins, IV, a witness for Petitioner who did
not testify in this trial. Id. Patent Owner argues that we should admit these
exhibits because they are relevant to other related matters (IPR2014-00073,
-00074, and -00075). Opp. to Mot. to Exclude (Paper 35) 2–4. Petitioner
similarly seeks to exclude Exhibits 2070–73 as irrelevant because Patent
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Owner does not cite to them. Mot. to Exclude 3. Patent Owner confirms
that it does not cite to these exhibits in this trial. Opp. to Mot. to Exclude 7.
Because neither we nor the parties rely on Exhibits 2013, 2014, 2016–18, or
2070–73 in this trial, Petitioner’s Motion is dismissed as moot as to these
exhibits.
Petitioner moves to exclude Exhibits 2033–36, 2042, and 2051 as
hearsay. Mot. to Exclude 2–3. Patent Owner argues that Exhibits 2033,
2035, and 2036 are offered to show the declarants’ states of mind. Opp. to
Mot. to Exclude 4–5 (citing FED. R. EVID. 803(3)). We agree that they are
offered for non-hearsay purposes. Therefore, we deny the motion to exclude
Exhibits 2033, 2035, and 2036. We do not rely on Exhibits 2034, 2042, and
2051. Therefore, Petitioner’s motion to exclude them is dismissed as moot.
Petitioner moves to exclude Exhibits 2039, 2041, 2056, 2058, 2059,
and 2066 as hearsay. Mot. to Exclude 4–5. Patent Owner introduces these
exhibits as financial industry objective indicia of commercial success and
praise. Patent Owner argues that these documents are introduced for non-
hearsay purposes, such as showing industry praise and the states of mind of
the declarants. Opp. to Mot. to Exclude 7–8. Petitioner contends that these
exhibits are not reliable because the authors of those exhibits are not skilled
artisans. Mot. to Exclude 4–5. We agree with Patent Owner (Opp. to Mot.
to Exclude 9), however, that the credentials of the authors go to the weight
of the evidence, not its admissibility. Accordingly, we deny Petitioner’s
motion to exclude Exhibits 2039, 2041, 2056, 2058, 2059, and 2066.
Petitioner moves to exclude Exhibit 2062 as being out of compliance
with 37 C.F.R. § 42.53. Mot. to Exclude 5. We do not rely on Exhibit 2062.
Therefore, Petitioner’s motion to exclude it is dismissed as moot.
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In sum, we deny-in-part and dismiss-in-part Petitioner’s Motion to
Exclude.

D. Asserted Grounds of Unpatentability
1. Obviousness Combinations Including Foley, Marino,
Obenchain, and NIM Guide
Petitioner raises several challenges to claims 1–12 of the ’535 patent
based in whole or in part on the combination of Foley, Marino, Obenchain,
and NIM Guide. Petitioner supports its contentions with the testimony of
Daniel Schwartz, Ph.D. (Ex. 1011, “Schwartz Decl.”).

a. Overview of Foley, Marino, Obenchain, and NIM
Guide
Foley is directed to a technique for providing a surgeon with a
working channel for access to a location in a patient during surgery, for
example to install a fusion device during spinal surgery. Ex. 1004, Abstract,
23:10–14. Figures 10a–10i of Foley illustrate creating a working channel by
inserting a guide wire (e.g., a K-wire), followed by a series of tissue dilators
(dilating cannulas) of increasing diameter and decreasing length
concentrically over each other to dilate the tissue sequentially. Id. at 12:1–
39, Figs. 10b–10d. After inserting the dilators, the surgeon inserts a working
channel cannula over the largest dilator (Fig. 10e) and removes the dilators,
leaving the working channel cannula to establish a working corridor
(Fig. 10f). Id. at 12:40–43. Although Foley describes a medial posterior
approach, Foley explains that this technique can “be used from any approach
and in other regions besides the spine,” id. at 11:63–67, e.g., “posterolateral”
and “anterior” approaches, id. at 12:6–8.
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In another embodiment, Figure 28 shows cannula 300 with obturator
210 disposed therein and protruding through an opening. Ex. 1005, 16:27–
33. In this embodiment, nerve-stimulating electrodes are included on the
distal tips of both the cannula and the obturator (electrodes 316 and 320,
respectively). Id. at 16:29–17:12.
Obenchain describes a cannula (elongated cylinder) for spinal surgery
(laparoscopic lumbar discectomy). Ex. 1001, Abstract, 1:32–33; 2:11–22.
Several surgical components can be secured in the cannula, for example, an
endoscope, a laser fiber, and irrigation conduits. Id. 2:39–3:34. One of the
approaches to the spine described in Obenchain is through the psoas muscle:
If desired, the surgery may traverse through the psoas muscle.
Where the surgery site is between LS and S-1, the dis[s]ection
is preferably generally close to the midline between the iliac
branches of the great vessels. Alternatively, for example, where
the patent 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 5:5–14.
NIM Guide is a user’s guide for an intraoperative EMG monitor. The
EMG monitor described in NIM Guide outputs to a probe a stimulus signal,
in the form of a monophasic square pulse, which a user can set to be
between 0.0 and 3.0 mA. Ex. 1009, at 4, 12, 21, 37. The monitor receives
EMG inputs from electrodes placed on the patient’s body and displays EMG
response information elicited by the stimulus signal. Id. at 6, 18. NIM
Guide illustrates a touch screen that displays EMG waveforms and receives
user input. Id. at 2, 6, 12, 21. According to NIM Guide, a user can program
the EMG monitor with an EMG activity event threshold, in µV. Id. at 7.
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EMG activity that exceeds this threshold is displayed on the screen. Id. at
10. The monitor also can generate an audible tone when the EMG response
amplitude exceeds the threshold. Id. at 29.

a. The Level of Ordinary Skill in the Art
Petitioner contends that a person of ordinary skill in the art would
have knowledge of both neurophysiology and spine surgery. Ex. 1011 ¶ 23.
Dr. Schwartz testifies that a skilled artisan, for example, could be a
neurophysiologist (like himself) with knowledge of spine surgery or access
to spine surgeons or a spine surgeon with experience in neurophysiology or
access to neurophysiologists. Id. Petitioner argues that Patent Owner’s
declarants, although spine surgeons, lack expertise in neurophysiology.
Reply 11–12.
Patent Owner, relying on the testimony of Frank Phillips, M.D.
(Ex. 2020, “Phillips Decl.”) ¶ 17, disagrees with Petitioner and contends that
a skilled artisan would have been a surgeon who has specialized in spine
surgery. Patent Owner argues that Petitioner’s declarant, Dr. Schwartz,
although having expertise in neuromonitoring, is not an expert in spine
surgery. PO Resp. 39.
We agree with Petitioner that the claims of the ’535 patent include
aspects of both spine surgery and neurophysiology. We recognize that each
declarant in this case has a particular expertise stronger in one aspect than
the other. Nevertheless, we have considered the testimony of each of the
declarants and have taken into account their respective expertise in weighing
their testimony.
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Both parties argue that the other party’s declarant was unfamiliar with
the legal standards for obviousness. PO Resp. 36–38; Reply 11–12. We
have taken the parties’ arguments into account in weighing the testimony of
the declarants. We recognize, however, that neither party’s declarants are
attorneys.
Patent Owner argues that Dr. Schwartz testified in deposition that his
opinions were from the perspective of a skilled artisan at the time of his
deposition, rather than from the time of the invention. PO Resp. 36.
Dr. Schwartz testified in his Declaration that his opinions are from the
perspective of a skilled artisan at the time of the invention. Ex. 1011 ¶ 22.
Considering the context of the deposition question to which Patent Owner
cites, we do not read Dr. Schwartz’s testimony to mean that he was
evaluating obviousness as of the time of the deposition. Ex. 2019, 188:1–
190:25.

b. Obviousness of Claims 1–12 over Foley, Marino,
Obenchain, and NIM Guide
Petitioner contends that claims 1–12 would have been obvious over
Foley, Marino, Obenchain, and NIM Guide. Specifically, Petitioner argues
that:
(1) Foley teaches spine surgery that includes insertion of a K-wire,
sequential insertion of a plurality of dilating cannulas of
increasing diameter and decreasing length to widen a corridor
through patient tissue, insertion of a working corridor
instrument, and delivery of an intervertebral implant;
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(2) Marino teaches an initial dilating cannula with an elongate
stimulation instrument disposed therein, each with stimulation
electrodes at its distal end, providing stimulus signals to the
stimulation electrodes, and receiving EMG response
information from EMG electrodes placed on a patient’s leg
muscles;
(3) Obenchain teaches spinal surgery using a trans-psoas approach;
and
(4) NIM Guide teaches a control unit for providing a monophasic
square wave signal to a probe and displaying corresponding
EMG response information compared to a threshold.
Pet. 20–23, 25–34. Petitioner points out, in its claim charts, how the
particular limitations of each of claims 1–12 are shown in the four
references. Id.
The parties dispute whether a skilled artisan would have had reason to
combine the teachings of Foley, Marino, Obenchain, and NIM Guide.
Essentially, Petitioner contends that a skilled artisan would have combined
Marino’s teaching of using an elongate stimulation instrument inside an
initial dilating cannula along with Foley’s teaching of a standard use of
dilating cannulas to arrive at a method in which an elongate stimulation
instrument is used inside Foley’s first (initial) dilator cannula to create an
approach for delivery of an implant. Pet. 23–24. Petitioner points to
Obenchain as giving an example of spinal surgery performed through the
psoas muscle using cannulated instruments. Id. at 21. Petitioner asserts that
a skilled artisan would combine further NIM Guide’s teaching as an example
of a standard EMG system that would be employed with the type of nerve
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monitoring described in Marino. Id. at 22–23. According to Petitioner, this
use of nerve monitoring “would have provided a useful indication of nerve
proximity throughout the surgery, as Marino intended.” Id. at 23. Petitioner
relies on the testimony of Dr. Schwartz in support of its arguments.
Ex. 1011 ¶¶ 75–90.
Petitioner argues that the teachings of each of these references are in
the context of improving minimally invasive spine surgery using cannulated
instruments. Pet. 23. According to Petitioner, a skilled artisan would have
had reason to combine Foley, Marino, Obenchain, and NIM Guide because
the nerve detection techniques of Marino and NIM Guide specifically are
intended to make the surgical procedures of Foley and Obenchain safer.
Id. at 23–24. Marino, for example, states that “[a]n advantage of
determining the position of a para-spinal nerve with respect to the distal tip
of the cannula in particular is that the para-spinal nerve can be avoided or
gently moved out of the surgeon’s way while inserting the cannula.”
Ex. 1005, 2:17–21. NIM Guide explains that its monitoring device “will
assist early nerve identification by providing the surgeon with a tool to help
locate and identify the particular nerve at risk within the surgical field” and
“will continuously monitor EMG activity from the muscles innervated by
the nerve at risk to minimize trauma and enhance neural preservation by
alerting the surgeon when a particular nerve has been activated.” Ex. 1009,
1:5–11. Petitioner further argues that Marino teaches that the elongate
stimulation instrument received within Marino’s cannula reduces the risk of
nerve damage during spine surgery, and that such teaching would have been
applicable to Foley’s procedures. Pet. 23–24.
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Patent Owner does not challenge Petitioner’s evidence of the
disclosure of the particular limitations of claims 1–12. Rather, Patent
Owner’s arguments are directed to its contention that a skilled artisan,
guided by conventional wisdom of the dangers of traversing the psoas
muscle, would not have combined Foley, Marino, Obenchain, and NIM
Guide.
Patent Owner argues that Obenchain, which describes a procedure of
passing a small endoscope through the anterior portion of the psoas muscle,
does not teach passing instruments (including multiple dilators and working
corridor instruments) safely through nerve-bearing portions of the psoas
muscle. PO Resp. 41. Patent Owner contends that the “conventional
wisdom” prior to its invention was to avoid the psoas muscle entirely as it
was a “no man’s land.” Id. at 43. Patent Owner relies on the testimony of
Theodore G. Obenchain, M.D., the named inventor on the Obenchain
reference. Id. (citing Ex. 2025 (“Obenchain Decl.”) ¶¶ 7, 9, 13–19).
According to Patent Owner and Dr. Obenchain, the Obenchain reference
only teaches traversing the psoas muscle incidentally, at its most anterior
fibers where the risk of incurring nerve injury is low, in cases where
avoiding the psoas muscle is impossible. PO Resp. 43, 45 (citing Ex. 2025
¶¶ 7, 14, 21). The express disclosure of Obenchain is not so limited,
however, as it states, without qualification, that “[i]f desired, the surgery
may traverse through the psoas muscle.” Ex. 1001, 5:5–6.
Patent Owner’s argument also improperly assumes that the claims
require a path through the nerve-rich portion of the psoas muscle. As
explained in Section II.A above and as Patent Owner effectively conceded, a
“trans-psoas path” is “a path in which the instrument passes through the
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psoas muscle” and is not limited to an approach through the middle or
posterior portion of the psoas muscle. See Tr. 39:10–40:1; 113:5–114:3.
Thus, even if we assume that Dr. Obenchain’s testimony, offered over 20
years after his patent was filed, can be used to limit the otherwise general
teaching of that patent to traversing only certain portions of the psoas
muscle, Patent Owner’s argument is unpersuasive because the claims of the
’535 patent do not require traversing any particular portion of the psoas
muscle.
Patent Owner also argues that Foley does not teach using its spinal
access system in a trans-psoas approach and that its disclosure of using its
system in “any approach” would not have suggested use through the psoas
muscle. PO Resp. 44, 48. Similarly, Patent Owner argues that Marino does
not teach a trans-psoas path. Id. at 49. Petitioner does not cite to Foley or
Marino as teaching performing spinal surgery through a trans-psoas path.
Rather, Obenchain is cited for that teaching. Pet. 25. Patent Owner argues
that neither Foley nor Obenchain teaches nerve monitoring functionality.
PO Resp. 48–49. Petitioner does not cite to Foley or Obenchain as teaching
nerve monitoring. Rather, Marino is cited for that teaching. Pet. 25–26.
Patent Owner’s arguments are unpersuasive because Patent Owner points
out deficiencies of individual references without adequately addressing their
combined teachings. See In re Keller, 642 F.2d 413, 426 (CCPA 1981)
(“[O]ne cannot show non-obviousness by attacking references individually
where, as here, the rejections are based on combinations of references.”).
In a similar argument, Patent Owner contends that there is “simply no
prior art cited in the Petition that discloses or suggests performing a spinal
fusion procedure through a trans-psoas approach to the spine.” PO Resp.
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51–52. This argument, again, does not address the combined teachings of,
inter alia, Foley (which teaches a spinal fusion procedure) and Obenchain
(which teaches spinal surgery through a trans-psoas approach).
Regarding Marino, Patent Owner argues that it describes avoiding
para-spinal nerves, which are different from the nerve roots found in the
psoas muscle. PO Resp. 49. Relying on Dr. Phillips, Patent Owner argues
that the consequences of damaging the nerves in the psoas muscle are more
severe and, thus, a teaching of avoiding the para-spinal nerves would not
lead a skilled artisan to believe that traversing the psoas muscle would be
safe. Id. at 49–50 (citing Ex. 2020 ¶¶ 19, 47, 70). We are not persuaded that
Marino’s teaching is limited to avoiding the para-spinal nerves. Rather,
Marino itself notes the general applicability of its technique, explaining that
it “can be used in all manner of minimally invasive surgery and is especially
useful for approaching any target site having sensitive nerves adjacent
thereto.” Ex. 1005, 16:20–22. Moreover, as explained above, the “trans-
psoas path” of the claims of the ’535 patent is not limited to a path through
the most nerve-rich and dangerous portions of the psoas muscle. We are
persuaded, therefore, by Petitioner’s evidence that a cannulated system, such
as Foley’s, equipped with nerve monitoring technology, predictably would
have had the benefits described in Marino, namely the ability to avoid nerves
during spinal surgery.
Patent Owner argues that the “generalized” disclosure of Marino
would not have provided a reason to traverse the non-nerve-rich portion of
the psoas muscle, per the teaching of Obenchain. PO Resp. 41–42, 45. We
do not, however, understand Patent Owner’s evidence to suggest that spinal
surgery performed through the anterior-most fibers of the psoas-muscle
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carries no risk of nerve damage; rather, this evidence suggests that it would
have been less dangerous. Thus, we are persuaded that Marino’s general
teaching would have been applicable regardless of whether the surgery
proceeded through the less-dangerous or more-dangerous portions of the
psoas muscle.
In sum, Petitioner has presented sufficient evidence to conclude that
every limitation of claims 1–12 of the ’535 patent is taught in one or more of
Foley, Marino, Obenchain, and NIM Guide. Petitioner also has introduced
persuasive evidence sufficient to show that a skilled artisan would have had
reason to combine the features of these references, e.g., combining the
features of these references would have been predictable.

c. Obviousness of Claim 6 over Foley, Marino,
Obenchain, NIM Guide, and Moed
Claim 6 depends from claim 1 and adds “wherein the elongate
stimulation instrument comprises a K-wire instrument insertable into the
initial dilator cannula.” Petitioner argues that such a K-wire instrument is
taught in Moed. Pet. 36–37.
Moed describes performing nerve monitoring during spine surgery
involving installing iliosacral implants (such as iliosacral screws). Ex. 1010,
at 1529. In particular, Moed describes using a 2.0 millimeter Kirschner wire
(K-wire) as an electrode for delivering a monopolar, monophasic square
wave stimulus signal. Id. at 1531, 1536. Petitioner argues that Moed
specifically describes the use of an electrified K-wire to detect nerve
proximity and that a person of ordinary skill in the art would have employed
Moed’s teachings to minimize the risk of neural injury during placement of
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implants during surgery. Pet. 37. Petitioner also argues that Moed
establishes that a guide wire, such as shown in Foley, could have been used
as a stimulation instrument. Id.
Patent Owner does not present separate arguments for this claim,
instead referring to its argument for claim 1. PO Resp. 53.
Based on this evidence, Petitioner has persuaded us that every
limitation of claim 6 is taught in one or more of Foley, Marino, Obenchain,
NIM Guide, and Moed. For the reasons given above, and in the Petition,
Petitioner has introduced persuasive evidence sufficient to show that
combining the features of these references would have been predictable.

d. Objective Indicia Do Not Evidence Non-Obviousness
Patent Owner contends that several objective indicia show non-
obviousness. In evaluating whether an invention would have been obvious,
“[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 Co., 383 U.S. 1, 17–18 (1966). While it
is Patent Owner’s burden to introduce evidence supporting such objective
indicia, see In re Huang, 100 F.3d 135, 139 (Fed. Cir. 1996), the ultimate
burden of persuasion never shifts to Patent Owner, see 35 U.S.C. 316(e).
Rather, objective indicia should be considered along with all of the other
evidence in making an obviousness determination. See Eurand, Inc. v.
Mylan Pharm. Inc. (In re Cyclobenzaprine Hydrochloride Extended–Release
Capsule Patent Litig.), 676 F.3d 1063, 1076–77 (Fed. Cir. 2012) (“It is to be
considered as part of all the evidence, not just when the decisionmaker
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remains in doubt after reviewing the art.”) (citing Stratoflex, Inc. v. Aeroquip
Corp., 713 F.2d 1530, 1538–39 (Fed. Cir. 1983)).
In short, Patent Owner argues that the conventional wisdom among
spine surgeons was that a lateral approach to the spine through the nerve-
rich portion of the psoas muscle was dangerous and that surgeons were
skeptical of procedures using that approach; nevertheless, there was a long-
felt need for such an approach to avoid the disadvantages of other
approaches; against this backdrop, Patent Owner developed a successful
technique for traversing the psoas muscle; and, as a result, Patent Owner
received extensive praise, created a new market, and ultimately achieved
commercial success. PO Resp. 9–34. Patent Owner supports its argument
with the Phillips Declaration (Ex. 2020) as well as the Obenchain
Declaration (Ex. 2025) and the declaration testimony of Patrick Miles
(Ex. 2024, “Miles Decl.”), an executive for Patent Owner.

(1) Nexus
“For objective evidence to be accorded substantial weight, its
proponent 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)).
Patent Owner’s objective evidence of non-obviousness is centered on
praise for, and success of, its “eXtreme Lateral Interbody Fusion” (XLIF)
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systems and methods. See, e.g., PO Resp. 12–14. Patent Owner, however,
does not establish adequately what XLIF is and whether it is encompassed
by the claims of the ’535 patent. Patent Owner repeatedly refers to features
of this technique with a high degree of generality, for example stating that it
is “the first minimally invasive lateral transpsoas approach to the lumbar
spine using nerve monitoring,” id. at 12, and quoting an article that describes
features of XLIF used in conjunction with another Patent Owner product
(EMG IOM, or NeuroVision®), id. at 13. We are unable to discern, from
such general evidence, how Patent Owner is mapping the features of XLIF
to the claims.
Patent Owner argues that Dr. Phillips, in his Declaration, compared
XLIF to the independent claims of the ’535 patent and concluded that “XLIF
procedure and systems” embody those claims. PO Resp. 14 (citing Ex. 2020
¶¶ 22–23, 27, Attachment E). Dr. Phillips, in turn, includes detailed claim
charts and citations to literature that purportedly describes an “XLIF
System.” See Ex. 2020, Attachment E. Patent Owner makes no attempt,
however, to explain in its Response how this evidence establishes a nexus.
Instead, it is an improper incorporation by reference of arguments from the
Phillips Declaration into the PO Response. See 37 C.F.R. § 42.6(a)(3)
(“Arguments must not be incorporated by reference from one document into
another document.”).
Additionally, it is unclear what product(s) Dr. Phillips is mapping to
the claims. Dr. Phillips cites to Exhibit 2028, which he alternately contends
describes the “XLIF surgical technique” and the “XLIF system.” Ex. 2020
¶ 22, Attachment E, p. 168. As its title suggests, however, Exhibit 2028
appears to describe a MaXcess II Access System, with XLIF being one
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surgical technique performable with this system. Ex. 2028, at 1. To the
extent XLIF is a “system,” it appears that such a system would not
correspond to the claims of the ’535 patent. For example, the XLIF
instrument system includes several surgical devices, but does not include
any cannulated devices with nerve monitoring capability. Ex. 2028, at 4.
Rather, Dr. Phillips relies on disclosure of the MaXcess II Access system to
show these features. Ex. 2020, Attachment E, p. 173–64, 178–79 (citing
Ex. 2028, at 8). Another portion of the document details the catalog
numbers of the components of the “XLIF System,” none of which includes
cannulated devices with nerve monitoring capability. Ex. 2028, at 24. In
contrast, dilators are included in the “MaXcess II Access System,” id. at 26,
and nerve monitoring appears to be provided by a “NeuroVision JJB
System” and disposable “NeuroVision JJB XLIF Module,” id. at 27.
It appears, from this evidence, that XLIF is a marketing term that is
sometimes used to identify a surgical technique and other times used to
identify groups of products. Thus, when Patent Owner uses the shorthand
term “XLIF” in its Response, without clarifying argument, we are unable to
associate Patent Owner’s objective evidence with particular products or
procedures. Rather, Patent Owner leaves it to us to figure out, on a case-by-
case basis, what it references by the term “XLIF.” That is the type of abuse
that the rule against incorporation by reference is designed to prevent.
See Rules of Practice for Trials Before The Patent Trial and Appeal Board
and Judicial Review of Patent Trial and Appeal Board Decisions; Final Rule,
77 Fed. Reg. 48,612, 48,617 (Aug. 14, 2012) (“In DeSilva v. DiLeonardi,
181 F.3d 865, 866–67 (7th Cir. 1999), the court rejected ‘adoption by
reference’ as a self-help increase in the length of the brief and noted that
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incorporation is a pointless imposition on the court’s time as it requires the
judges to play archeologist with the record. The same rationale applies to
Board proceedings.”). Accordingly, Patent Owner’s general identification of
XLIF as practicing the claims of the ’535 patent is insufficient to show
nexus.
Moreover, Patent Owner’s objective indicia arguments all focus on
the “key non-obvious inventive concept central to all of the claimed
inventions of the NuVasive XLIF Patents[, namely,] the use of nerve
monitoring techniques to safely traverse the psoas muscle during a spinal
procedure and/or the specific devices (namely stimulated dilators) developed
for such a procedure.” Ex. 2020 (Phillips Decl.) ¶ 23. As Petitioner points
out (Reply 8), Patent Owner’s arguments assume that the claims require an
“extreme” or “direct” lateral approach, as opposed to what Patent Owner
argues is an incidental traversal of the psoas muscle in its characterization of
Obenchain. As explained in Section II.A above, an extreme or direct lateral
path through the psoas muscle is not a requirement of the claims. Even if we
were to find a correspondence between XLIF and the claims, the “key non-
obvious inventive concept” on which Patent Owner primarily relies is not a
requirement of the claims.
Accordingly, Patent Owner’s evidence does not establish a nexus
between its objective indicia and the novel elements of the claims, and such
objective evidence is entitled to little weight.

(2) Long-felt need
“Evidence that an invention satisfied a long-felt and unmet need that
existed on the patent’s filing date is a secondary consideration of
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nonobviousness.” Perfect Web Techs., Inc. v. InfoUSA, Inc., 587 F.3d 1324,
1332 (Fed. Cir. 2009). To show a long-felt need, Patent Owner must
introduce evidence to show when such a need first arose and how long this
need was felt, and must introduce evidence to show that this need was met
by the patented invention. Id. “[L]ong-felt need is analyzed as of the date of
an articulated identified problem and evidence of efforts to solve that
problem.” Tex. Instruments, Inc. v. U.S. Int’l Trade Comm’n, 988 F.2d
1165, 1178 (Fed. Cir. 1993).
Patent Owner contends that, prior to the ’535 patent, surgeons
preferred to perform lumbar spinal interbody fusion surgery by approaching
the spine from anterior (from the front of the patient) and posterior (from the
back of the patient) directions, rather than a lateral direction (from the side
of the patient) through the psoas muscle. PO Resp. 3–4. According to
Dr. Phillips, the psoas muscle includes nerve roots that control important
bodily functions and, if injured, are unlikely to heal. Id. at 9–10 (citing
Ex. 2020 ¶¶ 18–20). Patent Owner argues that the locations of these nerves
are unpredictable. PO Resp. 10.
Other approaches, however, have severe drawbacks, Patent Owner
argues. Id. at 10–11. According to Dr. Phillips, an anterior approach risks
injuring the aorta and vena cava, among other issues, and a posterior
approach requires removal of significant bone structure to access spinal disc
space. Id. (citing Ex. 2020 ¶¶ 38–43). Patent Owner argues that, despite the
drawbacks of anterior and posterior approaches, they were still preferred to
lateral approaches, illustrating the severity of surgeons’ concerns regarding a
trans-psoas approach. PO Resp. 11. Patent Owner further argues that
Petitioner had access to all of the technology it cites in this case, yet “it
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never occurred to Medtronic or anyone working with Medtronic, including
Dr. Obenchain himself to combine nerve monitoring with instruments to
safely and reproducibly create a lateral transpsoas approach to the lumbar
spine.” Id. at 12. Patent Owner also cites to what it characterizes as
experimental attempts to lateral approaches that failed to gain widespread
adoption. Id. at 12. According to Patent Owner, except for the incidental
traversal of the psoas muscle described in Obenchain, these attempts either
retracted the psoas muscle or did not mention it at all. Id.
Although Patent Owner has introduced evidence to show that each of
the possible approaches has disadvantages and risks of patient injury, Patent
Owner’s evidence does not show that there was a long-felt need for a safe,
reproducible lateral trans-psoas approach to the spine. Rather, at most, it
shows that surgeons weighed the risks of each approach and opted for
anterior and posterior approaches. Indeed, Petitioner introduces evidence
that approaches other than lateral trans-psoas still comprise the majority of
such spinal surgeries today. Reply 5.
Patent Owner’s evidence is not sufficient to show a long-felt need.
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
solved. 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 trans-psoas approach. See Iron Grip
Barbell Co., Inc. 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); In re Allen, 324 F.2d 993, 997
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(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.”).
Even assuming Patent Owner’s evidence shows a long-felt need,
Patent Owner has not shown that such a need was met by the invention of
the ’535 patent. To show that such a need was met, Patent Owner argues
that its XLIF solution uses nerve monitoring to safely traverse the psoas
muscle in an extreme lateral approach. PO Resp. 13. As explained in
Section II.D.1.d(1) above, Patent Owner’s evidence does not establish a
nexus between XLIF (or an extreme lateral approach) and the claims.
Accordingly, we are not persuaded by Patent Owner’s evidence of
long-felt need or its product’s satisfaction of such a need.

(3) Skepticism followed by Praise and Recognition
Skepticism that a patented device would work, followed by
widespread acceptance and praise, can evidence non-obviousness of an
invention. See Kinetic Concepts, Inc. v. Smith & Nephew, Inc., 688 F.3d
1342, 1367–68 (Fed. Cir. 2012).
Patent Owner presents evidence that skilled artisans were initially
skeptical of using XLIF in a trans-psoas approach, fearing it would be
dangerous to the patient. PO Resp. 14–16. Much of this evidence consists
of personal recollections of Dr. Phillips, including his recollections of
conversations he had with surgeons (including those from Petitioner) in the
2003–2006 time frame as well as his review of deposition transcripts in
related litigation. Ex. 2020 ¶¶ 28–33. Patent Owner also cites
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Dr. Obenchain as testifying that he would have been skeptical at that time.
PO Resp. 16 (citing Ex. 2025 ¶¶ 15, 21).
As Petitioner points out (Reply 5–6), the objectivity of this evidence is
questionable, as both Dr. Phillips and Dr. Obenchain are paid consultants to
Patent Owner and are testifying long after the fact. See Ex. 2020 ¶¶ 1, 5;
Tr. 143:6–23. See also InTouch Techs., Inc. v. VGO Communications, Inc.,
751 F.3d 1327, 1347, 1352 (Fed. Cir. 2014) (“[T]he district court must
consider evidence showing objective indicia of nonobviousness, which
constitutes independent evidence of nonobviousness” (internal quotation
marks omitted, emphasis added) in order to “guard against . . . hindsight
bias.” ); Geo. M. Martin Co. v. Alliance Machine Sys. Int’l, LLC, 618 F.3d
1294, 1305 (Fed. Cir. 2010) (discounting “self-serving statements by
Martin’s president”). Even if fully credited, however, Patent Owner’s
evidence is not persuasive to show a nexus between XLIF and the claims, as
explained above.
As to eventual acceptance and praise, Patent Owner introduces
evidence, mainly the recollection of Mr. Miles, an executive of Patent
Owner, that one-by-one, surgeons stopped doubting XLIF and began to
adopt it. PO Resp. 16–18 (citing Ex. 2024 ¶¶ 14–15). Additionally, Patent
Owner introduces articles stating that XLIF and NeuroVision® are safe and
reproducible and that nerve-sensing is an important part of that. PO Resp.
18–21. Much (but not all) of this evidence was funded by Patent Owner.
See, e.g., Ex. 2030, at 2; Ex. 2052, at 228; Ex. 2053, at 6. As the Federal
Circuit has stated, “objective indicia of nonobviousness serve a particularly
important role in a case, like this one, where there is a battle of scientific
experts regarding the obviousness of the invention [because they] provide an
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unbiased indication regarding the credibility of that evidence.” Kinetic
Concepts, 688 F.3d at 1370–71 (emphasis added). Here, Patent Owner’s
evidence is less persuasive as an indication of the perceptions of
independent, unbiased, surgeons because it was funded, at least in part, by
Patent Owner.
Patent Owner also points to several examples of “improved patient
outcomes,” including testimonials from doctors and patients that XLIF
resulted in decreased risks and complications. PO Resp. 21–26. This
evidence discusses the benefits of XLIF generally. Other than one statement
mentioning “strict adherence to surgical technique including
neuromonitoring” (Ex. 2055, at 5), however, Patent Owner’s testimonials do
not discuss the use of nerve monitoring to traverse the psoas muscle or any
other features of the claims.
In any case, as explained above, Patent Owner’s evidence does not
show a nexus between XLIF and the claims.

(4) Commercial Success
Patent Owner argues that XLIF was introduced in 2003, that Patent
Owner’s revenues in 2004 were approximately $38 million, and that, by
2013, those revenues had grown to approximately $685 million. PO
Resp. 27. According to Patent Owner, its commercial success has been “a
direct result of its XLIF procedure and systems and the technology claimed
by the ’535 patent.” Id. at 28. In support, Patent Owner relies on reports of
market research from financial analysts crediting its success, at least in part,
to XLIF. Id. at 28–30; Ex. 2041, at 289 (“The majority of NuVasive’s
revenue is directly related to the XLIF procedure and its related devices”);
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Ex. 2056, at 1, 3 (J.P. Morgan report attributing success to Maximum Access
Surgery (MAS) platform, XLIF, NeuroVision®, and heavy salesforce
investment); Ex. 2058, at 12 (Canaccord Genuity report attributing success
to the “critical component” NeuroVision® and MaXcess retractor system);
Ex. 2059, at 3–4 (Caris & Co. report stating that Patent Owner’s core
products are the MAS platform and XLIF).
Petitioner argues that Patent Owner owes its success to sales of
unclaimed implants, sales of its MaXcess retractor system, and marketing to
and training of surgeons, among other things. Reply 5–8. “A prima facie
case of nexus is made when the patentee shows both that there is commercial
success, and that the product that is commercially successful is the invention
disclosed and claimed in the patent.” Crocs, Inc. v. U.S. Int’l Trade
Comm’n, 598 F.3d 1294, 1310–11 (Fed. Cir. 2010). As explained in Section
II.D.1.d(1) above, however, Patent Owner has not shown a correspondence
between XLIF (or, for that matter, NueroVision, MaXcess retractor system,
and the MAS platform) and the claims.
Moreover, Patent Owner has not been consistent in its attribution of
commercial success. In this matter, Patent Owner argues that “XLIF’s
commercial success (and by extension NuVasive’s) is a direct result of the
novel combination of the minimally invasive nerve monitoring enabled
distractor(s)/dilator(s) with NuVasive’s nerve monitoring system to safely
and reproducibly perform a lateral transpsoas approach to the lumbar spine
as claimed by the ’535 patent.” PO Resp. 30–31. In contrast, in IPR2014-
00075, Patent Owner attributed its commercial success to a system that
included both nerve monitoring and a retractor, stating that
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XLIF’s commercial success (and by extension 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.
IPR2014-00075, Paper 26, at 30–31. As Petitioner points out (Reply 8–9),
in yet another example, Patent Owner attributed its commercial success to its
implants, stating that “the detailed testimony establishes a nexus between
NuVasive’s CoRoent XL implants and the invention of the ’156 patent, and
proves the commercial success of the product after NuVasive pioneered the
market for lateral, trans-psoas interbody fusion surgeries with the CoRoent
XL implant.” Ex. 1026 (Medtronic, Inc. v. NuVasive, Inc., IPR2013-00506,
Paper 21 (PTAB May 21, 2014)) at 59. Patent Owner has made no
argument that we should consider several or all of its patents in the
aggregate to show commercial success. Cf. Apple Inc. v. Samsung
Electronics Co., Ltd., 735 F.3d 1352, 1365 (Fed. Cir. 2013) (“[I]t may make
sense to view patents in the aggregate where they all relate to the same
technology or where they combine to make a product significantly more
valuable.”).
In addition, Petitioner directs us to evidence that the commercial
success asserted by Patent Owner resulted, at least in part, from factors not
associated with either the claims 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:
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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, at 69 (emphasis added). Thus, even if Patent Owner were able to
show that XLIF embodies the claims of the ’535 patent, Petitioner has
shown persuasive evidence that products other than XLIF were the primary
drivers of Patent Owner’s commercial success.
Patent Owner also argues that XLIF created an entirely new market
segment. PO Resp. 27–28. In support, Patent Owner points to documents
from Petitioner referring to a “minimally invasive fusion market” (Ex. 2001,
at 81), and “Lateral IB Market Share,” (Ex. 2003, at 102). It is unclear
precisely what these particular markets include. For example, Exhibit 2001
shows Petitioner as having a larger share of the “minimally invasive fusion
market” than Patent Owner from the year 2005 to 2008, while Exhibit 2003
shows Petitioner as having a smaller share of the “Lateral IB Market” than
Patent Owner from the year 2005 to 2008. We doubt that these two exhibits
are discussing the same market. Moreover, Petitioner argues that the market

1 Consistent with the PO Response, we refer to the numbering at the bottom,
right corner of the pages of Exhibit 2001.
2 Consistent with the PO Response, we refer to the numbering at the bottom,
left corner of the pages of Exhibit 2003.
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is the overall fusion market and that Patent Owner has less than 5% share of
that market. Reply 5. The evidence Patent Owner presents is not sufficient
to ascertain what is included in the markets to which Patent Owner refers.
In sum, Patent Owner’s evidence is not sufficient to show its
commercial success relative to the market or that any such commercial
success is due to a product practicing the patent or, more precisely, due to
the novel features of the ’535 patent claims.

(5) Copying
Patent Owner contends that Petitioner and other competitors copied its
XLIF technology. PO Resp. 31–34. According to the Federal Circuit,
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.
Wyers v. Master Lock Co., 616 F.3d 1231, 1246 (Fed. Cir. 2010).
Patent Owner relies on Petitioner’s internal documents, one of which
states that Patent Owner pioneered the lateral approach (Ex. 2001, at 8), and
another that discusses XLIF (Ex. 2086, at 3), arguing that these documents
show an internal recognition of XLIF. PO Resp. 31–33. Patent Owner then
cites to a financial analyst report (from Caris Co.) stating that Petitioner
introduced Direct Lateral Interbody Fusion (DLIF), its own version of XLIF.
PO Resp. 33 (citing Ex. 2059, at 4). We are not persuaded of copying by
Petitioner. Even assuming that XLIF practices the claims of the ’535 patent
(which Patent Owner’s evidence does not show), Patent Owner has not
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introduced evidence sufficient to show the details of DLIF and, thus, Patent
Owner’s evidence does not show that DLIF practices the claims or was
replicated from observations or studies of XLIF.
Patent Owner, citing a financial analyst report (from J.P. Morgan)
further argues that other competitors introduced competing products and,
thus, copied XLIF. PO Resp. 34 (citing Ex. 2066, at 1). This evidence
similarly lacks sufficient detail to determine whether the competing products
practice the claims or ascertain whether they were copied from XLIF.
In sum, Patent Owner’s evidence does not show efforts by Petitioner,
or others, to replicate XLIF. Accordingly, we are not persuaded that
objective indicia of copying evidences non-obviousness.

e. Conclusion of Obviousness
As explained above, the prior art teaches each limitation of claims 1–
12. Petitioner has introduced persuasive evidence that a skilled artisan
would have had reasons to combine the prior art to arrive at these claims.
We have weighed Petitioner’s evidence against the objective evidence
presented by Patent Owner. We consider that objective evidence to be
entitled to little weight for the reasons given above. In sum, upon
consideration of all the evidence, including the evidence in the Petition and
Patent Owner’s objective indicia of non-obviousness, we conclude that
Petitioner has proved by a preponderance of the evidence that claims 1–12
would have been obvious over Foley, Marino, Obenchain, and NIM Guide
and that claim 6 would have been obvious over Foley, Marino, Obenchain,
NIM Guide, and Moed.

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2. Obviousness Combinations Including Kelleher, Foley, and
Obenchain
Petitioner raises several challenges to claims 1–12 of the ’535 patent
based in whole or in part on the combination of Kelleher, Foley, and
Obenchain. Petitioner supports its contentions with the testimony of
Dr. Schwartz (Ex. 1011).
Obenchain and Foley are discussed above.

a. Overview of Kelleher
Kelleher describes a system and method for sensing the presence of a
nerve during spine surgery. Ex. 1006, 1, 2:24–29. The system includes one
or more probes with stimulation electrodes for stimulating nerves and EMG
electrodes positioned on a patient’s body for detecting corresponding EMG
responses. Id. at 4:1–9, 10:7–11. In one example, the probes can include an
electrified cannula paired with a second probe within the cannula
functioning as a “confirmation electrode.” Id. at 8:3–9. In this case, the
cannula acts as a probe as it is advanced into the patient. Id. at 8:9–12.
When the cannula is in place, the confirmation electrode can be used to
ensure that a nerve has not slipped into the operating space within the
cannula. Id. at 8:15–20.
Kelleher’s nerve detection system also includes a pulse generator that
supplies a train of pulses to the stimulation electrodes. Id. at 23:10–20,
Fig. 7. The system further receives inputs from the EMG electrodes,
positioned on the legs of the patient, that detect EMG responses from the
patient elicited by the stimulation electrodes. Id. at 11:21–30, 23:30–31.
The EMG response data from the patient is displayed, for example, on a
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display using color LEDs. Id. at 15:12–30, Figs. 8a, 8b. The system can
generate pulses of progressively higher stimulation current (e.g., a staircase),
receive an EMG response, and generate a particular alarm level
corresponding to the stimulation current level that elicits the response. Id. at
17:23–34. The alarm level indicates the probe’s proximity to the nerve that
generated the EMG response. Id.

b. Obviousness of Claims 1–11 over Kelleher, Foley,
and Obenchain
Petitioner contends that claims 1–11 would have been obvious over
Kelleher, Foley, and Obenchain. Specifically, Petitioner argues that
(1) Foley teaches spine surgery that includes insertion of a K-wire,
sequential insertion of a plurality of dilating cannulas of
increasing diameter and decreasing length to widen a corridor
through patient tissue, insertion of a working corridor
instrument, and delivery of an intervertebral implant;
(2) Kelleher teaches an initial dilating cannula and a probe
disposed therein, both with stimulation electrodes at their distal
ends, and a control unit for providing stimulus pulses to the
stimulation electrodes, receiving EMG response information
from EMG electrodes placed on a patient’s leg muscles, and
displaying corresponding EMG response information compared
to a threshold; and
(3) Obenchain teaches spinal surgery using a trans-psoas approach.
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Pet. 37–39, 42–49. Petitioner points out, in its claim charts, how the
particular limitations of each of claims 1–11 are shown in the four
references. Id.
The parties dispute whether a skilled artisan would have had reason to
combine Foley, Kelleher, and Obenchain. Essentially, Petitioner contends
that a skilled artisan would have combined Kelleher’s teaching of adding
stimulation electrodes to elongate instruments with Foley’s teachings of
dilator cannulas and working corridor instruments to arrive at a method for
establishing an operative corridor, through areas where nerve damage is a
concern, for delivering a spinal fusion implants. Pet. 38–39. Petitioner
points to Obenchain as giving an example of spinal surgery performed
through the psoas muscle using cannulated instruments. Id. at 38–39.
Petitioner contends that Kelleher also teaches a control unit that provides a
stimulation signal and includes a graphical user interface for displaying
neuromuscular response information. Id. at 39.
Petitioner argues that the teaching of each of these references is in the
context of minimally invasive spine surgery using cannulated instruments.
Pet. 40. According to Petitioner, a skilled artisan would have had reason to
combine Kelleher, Foley, and Obenchain to enhance patient safety by
avoiding nerve damage. Id. at 39–40. In particular, Kelleher discloses, “it is
especially important to sense the presence of spinal nerves when performing
spinal surgery, since these nerves are responsible for the control of major
body functions.” Ex. 1006, 1:15–17. Kelleher also discloses that “a
downside of . . . minimally invasive surgical procedures [is] that they tend to
offer a somewhat reduced visibility of the patient’s tissues during the
surgery. Accordingly, the danger of inadvertently contacting and/or
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severing a patient’s nerves can be increased.” Id. at 1:22–24. Petitioner
argues that Kelleher’s devices are intended for the same spinal procedures
discussed in Foley and that Foley describes a typical spinal surgery
procedure that would have used Kelleher’s nerve monitoring system.
Pet. 40.
Patent Owner does not challenge Petitioner’s evidence of the
disclosure of the particular limitations of claims 1–11. Rather, Patent Owner
contends that a skilled artisan would not have combined Foley, Kelleher, and
Obenchain for the same reasons as it gave for Foley, Marino, Obenchain,
and NIM Guide. PO Resp. 53. Patent Owner summarizes its previous
arguments regarding the purported deficiencies of Foley and Obenchain,
arguing that, in light of conventional wisdom regarding the danger of
traversing the psoas muscle, a skilled artisan would not have combined
Foley and Obenchain to deliver a spinal fusion implant through a trans-psoas
operative corridor. Id. at 54–54, 57. For the reasons given in Section
II.D.1.b above, those arguments are unpersuasive.
Regarding Kelleher specifically, Patent Owner argues that “Kelleher
suffers from . . . essentially the same flaws as Marino, thereby providing no
reason to modify Foley in light of Kelleher and Obenchain.” Id. at 53.
According to Patent Owner, Kelleher does not teach traversing the psoas
muscle with the aid of nerve monitoring. Id. at 55–56. We are not
persuaded by Patent Owner’s arguments. As with Marino, we find
persuasive Petitioner’s evidence showing the general applicability of
Kelleher’s nerve monitoring techniques to surgery performed wherever there
is a risk of nerve damage. In particular, we are persuaded by Petitioner’s
evidence that a cannulated system, such as Foley’s, equipped with nerve
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monitoring technology, per Kelleher’s teaching, predictably would have had
the benefits described in Kelleher, namely the ability to avoid nerves during
spinal surgery.
In sum, Petitioner has presented sufficient evidence to conclude that
every limitation of claims 1–11 of the ’535 patent is taught in one or more of
Kelleher, Foley, and Obenchain. Petitioner also has introduced persuasive
evidence sufficient to show that combining the features of these references
would have been predictable.

c. Obviousness of Claim 12 over Kelleher, Foley,
Obenchain, and Isley
Claim 12 ultimately depends from claim 1, through claims 10 and 8,
and adds “wherein the stimulation current pulses of the signal delivered by
the elongate stimulation instrument comprises rectangular monophasic
current pulses output from the elongate stimulation instrument when the
initial dilator cannula and the elongate stimulation instrument are inserted
into the trans-psoas path toward the spine.” Petitioner cites to Isley as
teaching a stimulation current in the form of rectangular monophasic current
pulses output from an elongate stimulation instrument. Pet. 41, 49–50
(citing Ex. 1007 at 110 (“To date, the pedicle screw stimulation technique
has been universally performed using monopolar stimulation with
monophasic, square-wave, constant current or constant voltage, pulses.”)).
Petitioner argues that Isley provides more detail as to the type of current that
would be used in Kelleher, which Petitioner asserts describes a system
performing the same surgeries as Isley’s system. Pet. 41–42 (citing
Ex. 1011 (Schwartz Decl.) ¶¶ 291–97).
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Patent Owner does not present separate arguments for this claim,
instead referring to its arguments for claim 1. PO Resp. 57.
Based on this evidence, Petitioner has persuaded us that every
limitation of claim 12 is taught in one or more of Kelleher, Foley,
Obenchain, and Isley. For the reasons given above, and in the Petition,
Petitioner has introduced persuasive evidence sufficient to show that
combining the features of these references would have been predictable.

d. Obviousness of Claim 6 over Kelleher, Foley,
Obenchain, NIM Guide, and Moed
Petitioner argues that claim 6 would have been obvious over Kelleher,
Foley, Obenchain, NIM Guide,3 and Moed. Pet. 51–52. Patent Owner does
not present separate arguments for this claim, instead referring to its
arguments for claim 1. PO Resp. 57.
For the reasons given in Section II.D.1.c above, Petitioner has shown
that Moed teaches the additional limitation of claim 6. For the reasons given
above, and in the Petition, Petitioner has introduced persuasive evidence
sufficient to show that combining the features of Kelleher, Foley,
Obenchain, and Moed would have been predictable.

3 Petitioner cites NIM Guide for limitations we find already taught in
Kelleher. Pet. 50–51. Patent Owner does not contend that Kelleher fails to
teach any limitation for which NIM Guide would be applicable.
Accordingly, we conclude that claim 6 would have been obvious over
Kelleher, Foley, Obenchain, and Moed, without resort to the additional
teachings of NIM Guide.
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e. Objective Indicia Do Not Evidence Non-Obviousness
Patent Owner’s objective evidence of non-obviousness is
unpersuasive for the reasons given in Section II.D.1.d above.

f. Conclusion of Obviousness
As explained above, the prior art teaches each limitation of claims 1–
12. Petitioner has introduced persuasive evidence that a skilled artisan
would have had reasons to combine the prior art to arrive at these claims.
We have weighed Petitioner’s evidence against the objective evidence
presented by Patent Owner. We consider that objective evidence to be
entitled to little weight for the reasons given above. In sum, upon
consideration of all the evidence, including the evidence in the Petition and
Patent Owner’s objective indicia of non-obviousness, we conclude that
Petitioner has proved by a preponderance of the evidence that claims 1–11
would have been obvious over Kelleher, Foley, and Obenchain; claim 12
would have been obvious over Kelleher, Foley, Obenchain, and Isley; and
claim 6 would have been obvious over Kelleher, Foley, Obenchain, and
Moed.

III. CONCLUSION
Petitioner has demonstrated by a preponderance of the evidence that
claims 1–12 are unpatentable based on the following grounds of
unpatentability:
(1) Claims 1–12 under 35 U.S.C. § 103(a) as obvious over Foley,
Marino, Obenchain, and NIM Guide;
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(2) Claim 6 under 35 U.S.C. § 103(a) as obvious over Foley, Marino,
Obenchain, NIM Guide, and Moed;
(3) Claims 1–11 under 35 U.S.C. § 103(a) as obvious over Kelleher,
Foley, and Obenchain;
(4) Claim 12 under 35 U.S.C. § 103(a) as obvious over Kelleher,
Foley, Obenchain, and Isley; and
(5) Claim 6 under 35 U.S.C. § 103(a) as obvious over Kelleher, Foley,
Obenchain, and Moed.

IV. ORDER
For the reasons given, it is
ORDERED that, based on a preponderance of the evidence, claims 1–
12 of U.S. Patent No. 8,005,535 B2 are held unpatentable;
FURTHER ORDERED that Petitioner’s Motion to Exclude is denied-
in-part and dismissed-in-part; 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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For PETITIONER:
Justin J. Oliver
Brian L. Klock
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