Medtronic, Inc.v.NuVasive, Inc.

Patent Trial and Appeal Board

Apr 3, 2015

12635418 (P.T.A.B. Apr. 3, 2015)

Trials@uspto.gov Paper 48
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 IPR2014-00073
Patent 8,192,356 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 8,
“Pet.”) requesting an inter partes review of claims 21, 22, 24–26, 30, and
33–37 of U.S. Patent No. 8,192,356 B2 (Ex. 1018, “the ’356 patent”).
NuVasive, Inc. (“Patent Owner”) filed a Preliminary Response (Paper 10,
“Prelim. Resp.”).
Petitioner relied upon the following references to show
unpatentability:
Ex. 1001 Cistac DE 100 48 790 A1 Apr. 25, 20021
(as translated, Ex. 1002)

Ex. 1003 Kelleher WO 01/37728 A1 May 31, 2001
Ex. 1004 Obenchain US 5,313,962 May 24, 1994
Ex. 1005 Mathews US 5,171,279 Dec. 15, 1992
Ex. 1006 Koros US 6,139,493 Oct. 31, 2000
Ex. 1007 Michelson US 5,772,661 June 30, 1998
Ex. 1008 Jones US 4,595,013 June 17, 1986
Ex. 1009 Branch US 6,945,933 B2 Sept. 20, 2005
(filed June 26, 2002)
Ex. 1010 Blewett WO 03/005887 A2 Jan. 23, 2003
(filed July 11, 2002)

1 Petitioner asserts that, “[r]egardless of the priority filing date of the ’356
patent,” Cistac is prior art under 35 U.S.C. § 102(b) because it was
“published more than a year prior to June 26, 2002.” Pet. 6. The first page
of the Cistac document shows a publication date of April 25, 2002, however.
Ex. 1001, 1.

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Ex. 1011 Onimus WO 00/27291 A1 May 18, 2000
(as translated, Ex. 1012)

Ex. 1013 NIM Guide MEDTRONIC XOMED SURGICAL PRODUCTS,
INC., NIM-RESPONSETM, NERVE INTEGRITY
MONITOR, INTRAOPERATIVE EMG MONITOR
USER’S GUIDE (2000).

We instituted inter partes review of claims 21, 22, 24, 30, and 33–37
on the following grounds of unpatentability:
References Basis Claims challenged
Cistac, Obenchain, Kelleher, and
Mathews
§ 103(a) 21, 30, 33, and 34
Cistac, Obenchain, Kelleher,
Mathews, and Koros
§ 103(a) 22 and 24
Cistac, Obenchain, Kelleher,
Mathews, and NIM Guide
§ 103(a) 35
Cistac, Obenchain, Kelleher,
Mathews, NIM Guide, and Jones
§ 103(a) 36 and 37
Branch, Obenchain, Blewett, and
Onimus
§ 103(a) 21, 30, and 33–37
Branch, Blewett, Obenchain,
Onimus, and Koros
§ 103(a) 22 and 24

Decision to Institute 32 (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 39 (“PO Opp.”). Petitioner filed a Reply to the Opposition
to the Motion to Exclude Evidence. Paper 42 (“Reply to Opp.”).
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Patent Owner filed a Motion for Observations on Cross Examination.
Paper 36 (“PO Mot. Obs.”). Petitioner filed a Response to that Motion.
Paper 38 (“Resp. to Mot. Obs.”).
Petitioner supported its Petition with Declarations by Robert G.
Watkins, IV, M.D. (“Watkins Pet. Decl.” (Ex. 1015)), Daniel Schwartz,
Ph.D. (“Schwartz Decl.” (Ex. 1016)), and David Hacker (“Hacker Decl.”
(Ex. 1017)). 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 47.
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 21, 22, 24, 30, and 33–37 of the ʼ356 patent are
unpatentable, based on some, but not all, of the grounds upon which trial
was instituted.
Petitioner’s Motion to Exclude Evidence is denied-in-part, and
dismissed-in-part as moot.
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B. Related Cases
Patent Owner has asserted the ’356 patent against Petitioner in
Warsaw Orthopedic Inc. v. NuVasive Inc., Case No. 3:12-cv-02738-CAB-
MDD (S.D. Cal.). Pet. 1; Paper 6 at 2.
In Medtronic, Inc. v. NuVasive, Inc., IPR2014-00074, we instituted
review of claims 21, 22, 24, 30, and 33–37 of the ’356 patent, on a distinct
set of grounds presented by Petitioner. IPR2014-00074, Paper 15.
Petitioner also has challenged a number of related patents in the following
proceedings in which trials were instituted: IPR2014-00034 (Patent
8,000,782), IPR2014-00075 (Patent 8,016,767), 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 ’356 Patent
The ’356 patent describes methods and apparatuses for accessing a
surgical target site, such as the lumbar spine, using minimally invasive
techniques. Ex. 1018, 1:30–2:58. The surgical target site is accessed by first
advancing a rigid, generally narrow (diameter about 1.5 millimeters), “K-
wire” through the patient’s tissue to the target site. Id. at 6:51–59. Then,
tissue dilators of increasing diameter are advanced over the K-wire to the
target site, so as to sequentially distract, that is, open up, an initial pathway
through the tissue to the site. Id. at 6:65–7:23.
Once the initial pathway through the tissue is formed, an operative
corridor for performing the surgery may be prepared by advancing a set of
retractor blades into the tissue opening, and attaching the blades to a pivot
linkage. Id. at 8:15–30, see also Figs. 8, 32 (showing pivot linkage 14 and
attached retractor blades 90, 92). The pivot linkage has handle-like pivot
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arms that allow the surgeon to spread the tissue-distracting elements farther
apart. See id. at Fig. 8 (showing pivot arms 60, 62, 64, and 66).
The ’356 patent explains that “retractor blades 90, 92 may be locked
in a desired position by tightening the respective nuts 82, 86 of the locking
assemblies 32, 34.” Id. at 8:28–30, see also Fig. 8. Once an operative
corridor is established, the surgeon can perform surgical procedures, such as
installing a spinal fusion implant. Id. at 6:31–35.
The ’356 patent discloses that any of the tissue-distracting
instruments, including dilators and retractor blades, may be equipped with
stimulation electrodes that allow the surgeon to monitor the location of
nerves in the patient, so as to avoid and not damage the nerves during
surgery. See id. at 9:40–59. The electrodes emit a stimulation signal that,
when sufficiently close to a nerve, causes an innervation response in the
muscle associated with the nerve. Id. at 9:51–57. Response to the
stimulation signal may be monitored visually, by a twitch in the muscle, or
detected using an electromyography (EMG) system, which includes
electrodes positioned on the patient’s muscles. Id. at 9:60–10:23, 11:14–32.
Claim 21, the only independent claim Petitioner challenges in this
proceeding, reads as follows:
21. A system for accessing a spinal disc of a lumbar
spine through an operative corridor, comprising:

a distraction assembly to create a tissue distraction
corridor to a lumbar spine, wherein said distraction
assembly comprises: an elongate penetration
member deliverable to a spinal disc along a
lateral, trans-psoas path to the lumbar spine such
that a distal tip region of the elongate penetration
member penetrates into an annulus of a spinal disc
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in the lumbar spine, and at least two dilators of
sequentially larger diameter deliverable to the
spinal disc along the lateral, trans-psoas path to
the lumbar spine, a first dilator of the at least two
dilators having a lumen configured to slidably
receive the elongate penetration member, at least
one of said at least two dilators including a
stimulation electrode to deliver electrical
stimulation for nerve monitoring when said
stimulation electrode is positioned in the lateral,
trans-psoas path to the lumbar spine; and

a retraction assembly comprising a plurality of retractor
blades that enlarge the tissue distraction corridor to
thereby form an operative corridor along the
lateral, trans-psoas path to the lumbar spine
when the plurality of retractor blades are delivered
to the lumbar spine, the retraction assembly further
comprising a blade holder apparatus that is
configured to releasably lock with the plurality of
retractor blades,

wherein when the plurality of retractor blades enlarge
the tissue distraction corridor to form the
operative corridor along the lateral, trans-psoas
path to the lumbar spine, the operative corridor is
dimensioned so as to pass an implant through the
operative corridor along the lateral, trans-psoas
path to the lumbar spine.

Id. at 18:60–19:24 (emphases added).
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]
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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. See In re Translogic Tech. Inc., 504 F.3d 1249, 1257
(Fed. Cir. 2007).
In the Decision to Institute we concluded that the recitations in claim
21 regarding the “lateral trans-psoas path to the lumbar spine” relate to an
intended use of the claimed apparatus. Dec. 8. Accordingly, we attributed
to those intended use recitations no particular structural limitations, beyond
an ability to be used in, or follow, a trans-psoas path in the manner recited in
the claim. Id. Neither party disputes that claim construction and we
maintain it in light of the record developed during trial. No other terms
require express construction for purposes of this Decision.
B. Effective Filing Date of the ’356 Patent
As discussed below, the disposition of the challenges based on the
Blewett reference depends on the priority date accorded to the challenged
claims. The ’356 patent claims priority to U.S. Provisional Application
No. 60/392,214 (Ex. 1019, “the ’214 application”), filed June 26, 2002.
Ex. 1018, 1:10–13. Petitioner contends that the ’356 patent is not entitled to
the benefit of the ’214 application’s filing date because the ’214 application
does not provide descriptive support for the blade holder apparatus being
“configured to releasably lock” with the plurality of retractor blades, as
recited in claim 21. Pet. 12; Ex. 1018, 19:17 (claim 21).
In the Institution Decision, on the record before us at that time, we
preliminarily found that claim 21 of the ’356 patent was not entitled to the
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benefit of the ’214 application’s filing date. Dec. 10–11. Patent Owner
responds that, based on images and handwritten notations in the ’214
application, and the supporting testimony of Dr. Phillips, an ordinarily
skilled artisan would have understood that the releasably locking blade
holder apparatus recited in claim 21 was adequately described in the ’214
application. PO Resp. 47–54.
As noted above, Petitioner bears the ultimate burden of showing
unpatentability by a preponderance of the evidence. 35 U.S.C. § 316(e).
Nonetheless, to establish descriptive support for a claim, “the written
description must include all of the limitations . . . , or the [proponent] must
show that any absent text is necessarily comprehended in the description
provided and would have been so understood at the time the patent
application was filed.” Hyatt v. Boone, 146 F.3d 1348, 1354–55 (Fed. Cir.
1998) (emphasis added).
We find, in light of Patent Owner’s contentions, that Petitioner has not
shown by a preponderance of the evidence that claim 21 of the ’356 patent
lacks descriptive support in the ’214 application.
The feature of claim 21 allegedly absent from the disclosure of the
’214 application is “a blade holder apparatus that is configured to releasably
lock with the plurality of retractor blades.” Ex. 1018, 19:16–18. To show
that an ordinarily skilled artisan necessarily would have comprehended this
structure in the ’214 application, Patent Owner directs us (PO Resp. 48–54)
to the color images of Figures 28–35, 43–46, 47–49, and 51–53 in the ’214
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application (see Ex. 2026, 49–104),2 black and white images corresponding
to a number of those color images (id. at 36–48), as well as handwritten
annotations to those images presented in the original disclosure of the ’214
application.
In particular, Patent Owner contends, and Dr. Phillips testifies, that
Figure 28B of the ’214 application (Ex. 2026, 78) shows three cylindrical
rods extending from the pivot linkage assembly (blade holder apparatus) of
the shown retractor, and Dr. Phillips identifies those rods as bolts, with the
right-most bolt having a nut tightened to it. PO Resp. 49; Ex. 2020 ¶ 83
(Phillips Decl.). Dr. Phillips testifies that Figure 35, depicting a later step in
the surgical procedure, shows posterior retractor blade 14 releasably locked
to the pivot linkage assembly by the nut and bolt assembly. Ex. 2020 ¶ 83.
Dr. Phillips notes that the annotations to the black and white version of
Figure 35 support this conclusion by stating that the posterior retractor blade
is “locked in place on speculum assembly.” Id. (emphasis omitted) (citing
Ex. 2026, 44 (“132sen.jpg”)). Dr. Phillips testifies that the annotations to
the black and white versions of Figures 46 and 48, 142sen.jpg and
145sen.jpg, respectively, similarly describe locking the anterior and caudal
retractor blades to the pivot linkage assembly using a nut and bolt assembly.
Ex. 2020 ¶¶ 84, 85.
As to the releasability of the retractor blades, Dr. Phillips testifies that
an ordinarily skilled artisan viewing the figures of the ’214 application
necessarily would have understood the retractor blades to be releasably

2 We cite to the page numbers inserted at the bottom of each page of Exhibit
2026.
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locked in place, because the ’214 application describes no evident
mechanism by which the blades would be permanently locked into position.
Id. ¶ 81. Dr. Phillips testifies further that permanently locking the blades in
place would have rendered the device unusable, making removal from the
patient, as well as re-use of the device, impractical. Id. ¶ 82. Dr. Phillips
testifies, therefore, that “I do not believe there is any basis to conclude that
the locking mechanism shown in the figures for affixing the blades to the
handle is somehow not a releasable locking mechanism. To the contrary, the
disclosure necessarily discloses a releasable locking mechanism.” Id.
Having reviewed the ’214 application, including the cited figures, in
light of Patent Owner’s contentions and Dr. Phillips’s testimony, we find
that the evidence supports Patent Owner’s assertion that an ordinarily skilled
artisan would have understood that the ’214 application described a system
for accessing a spinal disc of a lumbar spine, the system including a blade
holder apparatus configured to releasably lock with a plurality of retractor
blades, as claim 21 of the ’356 patent requires. Because that element is the
sole feature of claim 21 urged by Petitioner as being absent from the ’214
application, we find also that the evidence does not support Petitioner’s
assertion that claim 21 of the ’356 patent is not entitled to the benefit of the
’214 application’s filing date.
Petitioner’s arguments do not persuade us to the contrary. It might be
true, as Petitioner argues (Reply 15 (citing Ex. 1024 ¶¶ 29–30 (Watkins
Reply Decl.))), that the cited figures of the ’214 application do not depict a
hexagonal shape or threading that would have indicated the locking elements
were nuts or bolts. Petitioner does not adequately explain, however, why the
absence of such depictions demonstrates that Dr. Phillips erroneously
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characterized those elements. As to Dr. Phillips’s testimony on cross
examination that he did not see a nut in Figure 28 of the ’214 application
(Reply 15 (citing Ex. 1038, 206:9–207:9 (Phillips Deposition)), we note that
on redirect examination he stated that he actually did see a nut-and-bolt
structure in Figure 28A. Ex. 1038, 208. Moreover, the fact that Dr. Phillips
might have misinterpreted one structure in one figure does not persuade us
that he erroneously characterized the overall disclosure of the ’214
application, including the several other figures which he referred to in his
testimony.
In sum, for the reasons discussed, Petitioner does not persuade us by a
preponderance of the evidence that claim 21 of the ’356 patent is not entitled
to the benefit of the ’214 application’s filing date. To the contrary, we
determine, for the reasons discussed, that the preponderance of the evidence
supports a finding that claim 21 of the ’356 patent, and its dependent claims
under consideration herein, claims 22, 24, 30, and 33–37, are entitled to the
benefit of the June 26, 2002, filing date of the ’214 application.
C. Asserted Grounds of Unpatentability
1. Obviousness Grounds Relying on Blewett
In the Institution Decision, we instituted review of claims 21, 22, 24,
30, and 33–37 of the ’356 patent on two grounds that relied upon the Blewett
reference, among others. Dec. 32. Petitioner asserts that “Blewett is prior
art under 35 U.S.C. § 102(a) because its January 23, 2003 publication date is
before the June 26, 2003 filing date of the ’362 application” to which the
’356 patent claims priority. Pet. 6.
As discussed above, however, claims 21, 22, 24, 30, and 33–37 of the
’356 patent are entitled to the benefit of the June 26, 2002, filing of the ’214
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provisional application, which is before Blewett’s January 23, 2003,
publication date. Accordingly, Petitioner does not persuade us by a
preponderance of the evidence that Blewett is prior art to claims 21, 22, 24,
30, and 33–37. We also are not persuaded, therefore, that Petitioner has
shown by a preponderance of the evidence that claims 21, 22, 24, 30, and
33–37 of the ’356 patent are unpatentable based on the challenges which
rely upon Blewett.
2. Obviousness of Claims 21, 30, 33, and 34 in view of Cistac,
Obenchain, Kelleher, and Mathews
a. Prior Art Evidence of Obviousness
In the Institution Decision, we instituted review of claims 21, 30, 33,
and 34 for obviousness in view of Cistac, Obenchain, Kelleher, and
Mathews. Dec. 11–19, 32. Petitioner’s position, essentially, is that an
ordinarily skilled artisan would have considered it obvious to equip the
dilators and retractor blades of the surgical system described by Cistac with
the nerve-monitoring electrodes taught by Kelleher. See Pet. 25–26, 30–31.
Petitioner cites Obenchain as evidence that the trans-psoas path to the
lumbar spine was known to be a suitable surgical approach to the lumbar
spine. Id. at 34. Petitioner cites Mathews as evidence that an ordinarily
skilled artisan would have considered it obvious to configure minimally
invasive surgical instruments intended for lumbar spine surgery to be
dimensioned so as to allow surgical implants to pass through them. Id. at
36–37.
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
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witnesses, are based on improper hindsight. PO Resp. 2–3, 34–36, 39–40.
Patent Owner argues also that the only motivation alleged in the Petition for
combining the cited references is for using a lateral, trans-psoas path to the
spine. Id. at 45. Patent Owner argues, however, that neither the cited prior
art, nor the knowledge of ordinarily skilled artisans at the time of the
invention, supports that rationale. Id. at 3–7, 42–46.
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.
John Deere Co., 383 U.S. 1, 17–18 (1966)). Secondary considerations, if
present, also must be considered. 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. 1015
¶ 11 (Watkins Decl.)); Ex. 2020 ¶ 17 (Phillips Decl.). Both experts,
nonetheless, generally agree that an ordinarily skilled artisan at the critical
time would have been either 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
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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 Cistac, Obenchain, Kelleher, and
Mathews, as compared to the subject matter recited in claims 21, 30, 33, and
34 of the ’356 patent, we determine that Petitioner has shown, based on the
teachings in the prior art, that an ordinarily skilled artisan would have been
prompted to prepare a surgical system having all of the features required by
the challenged claims.
Specifically, Cistac discloses that, “[t]o create a percutaneous access,
as is required in a lumbar discectomy for example, it is known to insert
tubular cannulas into the body and to arrange additional instruments on these
by means of a positioning plate or by means of a positioning sleeve . . . .”
Ex. 1002, 1:12–16. To that end, Cistac discloses a “device for creating a
percutaneous access into a body, with two retractor blades which together
form an access channel . . . .” Id. at 1:5–7. As seen in Figure 2 of Cistac,
the two retractor blades 26 are semicircular in cross section. Id. at Fig. 2.
As required by claim 21, Cistac discloses that its device includes a
blade holder apparatus that releasably locks with the retractor blades. See
id. at 5:31–34 (“The retractor blades can be held releasably on the carrying
elements, such that it is possible for retractor blades that are suitable for the
specific operation to the secured on the carrying elements.”).
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As also required by claim 21, Cistac discloses that, for initial access
into the patient, its system includes an elongate penetration member, in the
form of a wire, and at least two dilators of sequentially larger diameter
deliverable to a spinal disc. Id. at 12.
Cistac explains that, after removing the initially inserted wire and
tube, the two semicircular retractor blades cooperatively “define a tubular
access into the interior of the body, the size of which access can be increased
by pivoting of the holding arms, for which purpose it suffices to actuate the
adjusting screw 7.” Id. at 12:36–13:3, see also Fig. 2. Cistac discloses that
the diameter of the retractor blades “can be of the order of 15 mm . . . .” Id.
at 14:16.
Although Cistac differs from claim 21 in not describing its dilators as
having nerve-monitoring stimulation electrodes as recited in the claim,
Kelleher discloses the desirability of including such electrodes on devices
used in spinal surgery. Ex. 1003, 1. 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.” Id. at 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 severing a
patient’s nerves can be increased.” Id. at 1:22–24.
Kelleher thus discloses a nerve detection system that has “an electrode
or electrodes positioned on the distal end of the surgical tool or probe, with
an electromyographic system used to detect whether a spinal nerve is
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positioned adjacent to the surgical tool or probe.” Id. at 4:2–4. Kelleher
explains:
A conclusion is made that the surgical tool or probe is
positioned adjacent to a spinal nerve when a neuro-muscular
(e.g.: EMG) response to a stimulus pulse emitted by the
electrode or electrodes on the surgical tool or probe is detected
(at a distant myotome location, such as on the patient’s legs) at
or below certain neuro-muscular response onset values (i.e.:
pre-determined current intensity levels) for each of the plurality
of spinal nerves.

Id. at 4:4–9.
Kelleher discloses that in “preferred aspects, the surgical tool or probe
may be introduced into the patient in a minimally invasive cannulated
approach.” Id. at 2:20–22. Kelleher further discloses that its electrified
probes “can be any manner of surgical tool, including (electrified) cannulae
through which other surgical tools are introduced into the patient.” Id. at
16:17–18.
Given Kelleher’s teaching of the desirability of equipping surgical
instruments with electrodes to detect nerves during spinal surgery when
using a minimally invasive cannulated approach, we agree with Petitioner
that an ordinarily skilled artisan would have been prompted to equip Cistac’s
dilators with the stimulating electrode required by claim 21 of the ’356
patent, in order to allow the surgeon to detect and avoid spinal nerves when
using Cistac’s cannulated surgical system. In view of Mathews’s teaching
of the desirability of delivering implants through a spine-accessing
minimally invasive operative corridor, see Ex. 1005, 5:50–6:16, we also
agree with Petitioner that, as required by claim 21, an ordinarily skilled
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artisan would have ensured that the operative corridor created by Cistac’s
system would be dimensioned to permit implant passage.
As to the intended use of the system recited in claim 21, as discussed
above, we attribute to the intended use recitations no particular structural
limitations, beyond an ability to be used in, or follow, a trans-psoas path, in
the manner recited in the claim. Because Cistac’s instruments are sized for
minimally invasive access to the lumbar spine, see Ex. 1002, 1:12–14, we
are persuaded that those instruments would be capable of the intended use
recited in claim 21. Moreover, although Obenchain focuses on approaches
other than a trans-psoas path, see Ex. 1004, 1:48–66, Obenchain discloses,
nonetheless, that minimally invasive surgery of the lumbar spine can use a
trans-psoas approach:
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, or
immediately in front of it.

Id. at 6:22–31.
In sum, given the discussed teachings of Cistac, Obenchain, Kelleher,
and Mathews, Petitioner persuades us that an ordinarily skilled artisan would
have been prompted to prepare a system having all of the elements of claim
21 of the ’356 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
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performing lumbar spinal surgery. PO Resp. 3–7 (citing Ex. 2020 ¶¶ 18–21,
36–47 (Phillips Decl.), Ex. 2025 ¶¶ 7, 13–16 (Obenchain Decl.)). As noted
above, however, the psoas-traversing pathway recited in claim 21 is merely
an intended use of the recited apparatus, and Patent Owner does not point
with specificity to any feature in the prior art apparatuses that would have
rendered them unsuitable or unusable in such an approach.
Further, in light of Kelleher’s express teachings, noted above, that its
nerve-sensing electrodes were generally desirable when performing spinal
surgery (see Ex. 1003, 1), and were suitably deployed on any surgical
instrument (id. at 16), we are not persuaded that Kelleher would have been
combined with Cistac only through hindsight, as Patent Owner argues
(PO Resp. 34–36, 39–40). Patent Owner argues that Drs. Watkins and
Schwartz lack proper qualifications and that their testimony suffered from
improper hindsight and the use of incorrect legal standards. PO Resp. 38–
41. Nevertheless, even if we accept this criticism, given the express
teachings in Kelleher, Petitioner persuades us that an ordinarily skilled
artisan would have been prompted to equip at least one of Cistac’s dilators
with Kelleher’s nerve-sensing electrodes, as claim 21 of the ’356 patent
requires.
Further, Kelleher discloses the usefulness of its electrodes in cervical
and thoracic surgeries (Ex. 1003, 7, 12), as well as illustrating their use in
lumbar spinal applications (id. at 12, Fig. 1), yet makes no express mention
of traversing the psoas muscle in any of these contexts. We are not
persuaded, therefore, that the sole reason for combining Kelleher and Cistac
would have been to allow navigation of the nerve plexus in the psoas
muscle, as Patent Owner contends. PO Resp. 45. In that regard, we note
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that, although Petitioner urged that the trans-psoas pathway would have
provided a “particular reason” to use nerve monitoring in spinal surgery
(Pet. 25), Petitioner also advanced a rationale for combining Cistac with
Kelleher without reference to the trans-psoas pathway:
It would have been obvious to one of ordinary skill in the
art to have used nerve monitoring with the minimally invasive
spinal access instruments of Cistac, such as Cistac’s dilators
(sleeves). Watkins Decl., ¶ 47. As taught by Kelleher, nerve
monitoring would have warned the user if the dilators moved
close to a nerve.

Id.
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 the teachings in those references, that an
ordinarily skilled artisan would have been prompted to prepare a system
having all of the elements of claim 21 of the ’356 patent. As to claim 21’s
dependent claims 30, 33, and 34, Patent Owner does not direct us to any
deficiency in Petitioner’s contentions that the teachings in Cistac,
Obenchain, Kelleher, and Mathews would have suggested a system having
the additional features recited in those claims. We have analyzed
Petitioner’s evidence regarding those references as compared to claims 30,
33, and 34 (see Pet. 30–31, 38–39), 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 having all of the elements
required by those claims.

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b. Secondary Considerations/Objective Indicia
Patent Owner contends that objective evidence shows that the claimed
surgical system would not have been obvious to an ordinarily skilled artisan.
PO Resp. 7–9. In particular, Patent Owner contends that its surgical 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, 7–11. Moreover, Petitioner
argues, the guidance along a trans-psoas pathway, upon which Patent Owner
bases its contentions regarding the objective indicia, is not a required
element of the challenged claims, which are directed to apparatuses. Id. at
2–3, 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, 383 U.S. at 17–18. Such objective indicia of nonobviousness must
be considered “as part of all the evidence, not just when the decision maker
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).
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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
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 the alleged need for a lateral, trans-
psoas pathway. PO Resp. 9–12. Similarly, in its contentions 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. Id. at
14–16 (citing Ex. 2020 ¶¶ 28–33 (Phillips Decl.), Ex. 2024 ¶¶ 12–15 (Miles
Decl.), Ex. 2025 ¶¶ 14–15, 21 (Obenchain Decl.)). As noted above,
however, the recitations in claim 21 regarding the lateral, trans-psoas
pathway relate only to the intended use of the claimed apparatus, and do not
require the apparatus to be used in that fashion. Indeed, the ’356 patent
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acknowledges that, rather than being limited or unique to the lateral trans-
psoas intended use, “the access system of the present invention is suitable
for use in any number of additional surgical procedures, including those
wherein tissue having significant neural structures must be passed.”
Ex. 1018, 3:19–21.
Moreover, even if practitioners preferred anterior or posterior
approaches to the lumbar spine rather than a lateral psoas-traversing
approach (PO Resp. 9–11), that does not persuade us that there existed a
long-felt but 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 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. 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 efforts were
not widespread, but instead involved no more than “a small handful of
patients.” PO Resp. 12.
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Patent Owner focuses on its “XLIF” (“eXtreme Lateral Interbody
Fusion”) system, in contending that the claimed surgical system allowed
surgeons to traverse the psoas muscle safely and reproducibly in order to
access the lumbar spine. PO Resp. 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 claims of the ’356 patent . . . [and] concluded that the
XLIF procedure and systems embody at least the independent claims of the
’356 patent.” Id. at 14 (citing Ex. 2020 ¶¶ 22–23, 27, Attachment C
(Phillips Decl.)).
We acknowledge that Dr. Phillips’s Declaration includes a chart
mapping the features of claim 21 of the ’356 patent to various disclosures in
Exhibit 2028. See Ex. 2020, 139–147 (Attachment C). 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 21, 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.”).
Even disregarding the procedural infirmities in Patent Owner’s
Response, Petitioner persuades us, nonetheless, that Patent Owner has not
established a sufficient nexus between the claimed subject matter and the
objective evidence of nonobviousness. Specifically, Patent Owner’s
evidence of industry praise, as well as improved patient outcomes, focuses
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on the use of the XLIF technique in a lateral trans-psoas approach. PO
Resp. 16–26. As noted above, however, because it is directed to an
apparatus, claim 21 simply does not require using that approach.
Moreover, as Petitioner argues (Reply 7–10), Patent Owner
acknowledges that a key aspect to the acceptability of the XLIF technique
was its 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 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), id. at 20 (“Dynamic, discrete-threshold EMG is an integral and
necessary part of the XLIF procedure.”) (emphasis removed). Patent Owner
acknowledges also that the XLIF system includes three dilators, each of
which includes a stimulation electrode. Ex. 2020, 142 (Phillips Decl.,
Attachment C).
In contrast, claim 21 does not require real-time, directional, or
automated nerve monitoring. Ex. 1018, 18:60–19:24. Rather, as to nerve
monitoring, the system of claim 21 merely includes two dilators, only one of
which must have a stimulation electrode for nerve monitoring. Id. at 19:6–
10. 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 21. Petitioner persuades us also, therefore, that Patent
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Owner has not established a nexus between the features of the XLIF system
that are asserted to have elicited praise, and the sole claim for which Patent
Owner presents specific argument as to secondary considerations. See
Ex. 2020, 139–147 (Phillips Decl. Attachment C) (comparing XLIF
(Ex. 2028) to claim 21 of the ’356 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)).
Patent Owner summarizes its commercial success contentions as
follows:
As the evidence shows, 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 ’356 patent. . . . Not only is this technology key
to XLIF, but it is key to creating an entirely new market for
fusion.

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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 30 (“The critical component obviously lies within its
NeuroVision offering and its MaXcess retractor system.”) (citing Ex. 2058
(emphasis removed), id. (“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).
Thus, although Patent Owner acknowledges that XLIF includes
certain features that are critical to its success, including a software-driven
nerve monitoring system and the use of the trans-psoas pathway, those
features are either not recited in, or not required by, claim 21. As to the
remaining claims under challenge, Patent Owner does not present any
specific argument explaining how the features of those claims correspond to
the elements of the XLIF system.
In addition, Petitioner directs us to evidence supporting its contention
that the commercial success asserted by Patent Owner resulted, at least in
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part, 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, Patent Owner acknowledges that the majority of its revenue had
come 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 21 of the ’356 patent. Also, Petitioner’s contention,
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that the success asserted by Patent Owner was attributable to factors
unrelated to the features of the claimed invention, is supported by the fact
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.
In sum, for the reasons provided, Petitioner persuades us that Patent
Owner has not explained with adequate specificity the nexus between its
evidence of commercial success and the subject matter recited in claim 21
and its dependents.
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
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Resp. 32–33 (citing Ex. 2086, 1, 3). Patent Owner asserts that Petitioner
subsequently introduced its own version of the XLIF system, “DLIF,” in
2006. Id. at 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:
[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. (quoting Ex. 2059, 4). Although this evidence 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 of the DLIF
system, nor does Patent Owner otherwise explain with specificity why the
particular features required by claim 21, or any of the other challenged
claims of the ’356 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.” PO Resp. 33 (quoting Ex. 2066, 1) (emphasis removed).
Again, however, although this evidence suggests that Patent Owner’s
competitors may have had nerve monitoring systems similar to XLIF, Patent
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Owner does not direct us to any evidence that describes the specific
components of its competitors’ systems, nor does Patent Owner otherwise
explain with specificity why the particular features required by the claim 21,
or any of the other challenged claims of the ’356 patent, are in its
competitors’ systems.
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 ’356 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 apparatuses
recited in the challenged claims.
c. 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
Cistac, Obenchain, Kelleher, and Mathews, that an ordinarily skilled artisan
would have been prompted to prepare a system having all of the elements of
claims 21, 30, 33, and 34 of the ’356 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 surgical systems recited
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in claims 21, 30, 33, and 34 of the ’356 patent obvious in view of Cistac,
Obenchain, Kelleher, and Mathews.
3. Remaining Grounds
In the Institution Decision, in addition to the grounds discussed above,
we instituted review of (1) claims 22 and 24 for obviousness over Cistac,
Obenchain, Kelleher, Mathews, and Koros; (2) claim 35 for obviousness
over Cistac, Obenchain, Kelleher, Mathews, and NIM Guide; and (3) claims
36 and 37 for obviousness over Cistac, Obenchain, Kelleher, Mathews, NIM
Guide, and Jones. Dec. 32. Each of claims 22, 24, and 35–37 depends
directly or ultimately from claim 21, and adds additional features to the
system recited in claim 21. Ex. 1018, 19:25–20:46. Petitioner cited the
Koros, NIM Guide, and Jones references to show that an ordinarily skilled
artisan would have considered those features obvious components of the
system suggested by Cistac, Obenchain, Kelleher, and Mathews. Pet. 27–
29, 31–33, 37–38, 39–41. We have considered that evidence, and agree that
the prior art teaches the remaining limitations of claims 22, 24, and 35–37.
Other than the arguments addressed above, Patent Owner does not assert
specifically any defect in Petitioner’s assertions or findings as to those
grounds or references, nor does Patent Owner assert any defect or deficiency
in our analysis of those grounds in the Institution Decision. See PO Resp.
57–58. 3 Accordingly, for the reasons discussed above, we conclude that

3 Patent Owner seeks to incorporate by reference the arguments made in its
Preliminary Response into its Response. PO Resp. 57–58. As noted above,
however, “[a]rguments must not be incorporated by reference from one
document into another document.” 37 C.F.R. § 42.6(a)(3).
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Petitioner has shown by a preponderance of the evidence that claims 22, 24,
and 35–37 would have been obvious to an ordinarily skilled artisan at the
time the claimed subject matter was invented.
4. 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
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. Mot. to Exclude 3–4.
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. 6–7.
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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.
III. CONCLUSION
For the reasons given, we are persuaded that Petitioner has shown by
a preponderance of the evidence that claims 21, 22, 24, 30, and 33–37 of the
’356 patent are unpatentable based on the following grounds of
unpatentability:
(1) Claims 21, 30, 33, and 34 under 35 U.S.C. § 103(a) as obvious
over Cistac, Obenchain, Kelleher, and Mathews;
(2) Claims 22 and 24 under 35 U.S.C. § 103(a) as obvious over
Cistac, Obenchain, Kelleher, Mathews, and Koros;
(3) Claim 35 under 35 U.S.C. § 103(a) as obvious over Cistac,
Obenchain, Kelleher, Mathews, and NIM Guide;
(4) Claims 36 and 37 under 35 U.S.C. § 103(a) as obvious over
Cistac, Obenchain, Kelleher, Mathews, NIM Guide, and Jones.
For the reasons given, we are not persuaded that Petitioner has shown
by a preponderance of the evidence that claims 21, 22, 24, 30, and 33–37 of
the ’356 patent are unpatentable based on the following grounds of
unpatentability:
(5) Claims 21, 30, and 33–37 under 35 U.S.C. § 103(a) as obvious
over Branch, Obenchain, Blewett, and Onimus; and
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(6) Claims 22 and 24 under 35 U.S.C. § 103(a) as obvious over
Branch, Blewett, Obenchain, Onimus, and Koros.
IV. ORDER
It is ORDERED that claims 21, 22, 24, 30, and 33–37 of the ’356
patent have been shown by a preponderance of the evidence to be
unpatentable;
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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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