Ex Parte 7691057 et al

Patent Trial and Appeal Board

Dec 19, 2016

95001888 (P.T.A.B. Dec. 19, 2016)

UNITED STATES PATENT AND TRADEMARKOFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
95/001,888 02/09/2012 7691057 41701.705.999 7222
21971 7590 12/19/2016
WILSON, SONSINI, GOODRICH & ROSATI
650 PAGE MILL ROAD
PALO ALTO, CA 94304-1050
EXAMINER
FLANAGAN, BEVERLY MEINDL
ART UNIT PAPER NUMBER
3993
MAIL DATE DELIVERY MODE
12/19/2016 PAPER
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

GLOBUS MEDICAL, INC.
Requester and Appellant

v.

NUVASIVE, INC.
Patent Owner and Respondent
____________

Appeal 2016-008303
Reexamination Control 95/001,888
Patent 7,691,057 B2
Technology Center 3900
____________

Before DANIEL S. SONG, RAE LYNN P. GUEST, and
BRETT C. MARTIN, Administrative Patent Judges.

GUEST, Administrative Patent Judge.

FINAL DECISION ON APPEAL UNDER 37 C.F.R. § 41.77(f)

In a Decision on Appeal mailed July 1, 2014 (hereinafter “Decision”),
the Board entered the following new grounds of rejection:
claims 17, 18, and 24 as rendered obvious by Branch in view of
Kossmann, and Koros (Ground 1; RAN 2);
claims 19–22 as rendered obvious by Branch in view of Kossmann,
Koros, and Kelleher (Ground 2; RAN 2);
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claim 25 as rendered obvious by Branch in view of Kossmann, Koros,
and Michelson (Ground 3; RAN 2);
claim 26 as rendered obvious by Branch in view of Kossmann, Koros,
and Tsou (Ground 4; RAN 2); and
claim 27 as rendered obvious by Branch in view of Kossmann, Koros,
Tsou, and Kelleher (Ground 5, RAN 2).
In response to the Decision, Patent Owner, NuVasive, Inc.1
(hereinafter “Patent Owner”) filed a Request to Reopen Prosecution on
September 4, 2014 (hereinafter “Request”).
On January 23, 2015, the Board ordered that the Patent Owner’s
Request be remanded to the Examiner under 37 C.F.R. § 41.77(d) for
consideration of Patent Owner’s proposed amendments to independent claim
17 by adding the step of performing a particular neuromonitoring method
during the step of creating a distraction corridor along a lateral trans-psoas
path (step (a)) and Patent Owner’s proposed amendment to claim 19, which
originally recited performing neuromonitoring “during at least one of steps
(a), (c), and (d),” to recite additional neuromonitoring during either steps (c)
or (d), to be consistent with the amendment to claim 17.2 The Examiner was
also asked to consider Patent Owner’s new evidence in the form of a
Declaration of Dr. Frank Phillips (hereinafter “Phillips Decl.”) and a
Declaration of Mr. Patrick Miles (hereinafter “Miles Decl.”), both dated

1 See Patent Owner Respondent Brief 1 (filed February 19, 2013)
(hereinafter “PO Res. Br.”).
2 We denied Patent Owner’s request for reconsideration of proposed
amendments to claims 23, 28, and 29, which were not subject to
reexamination.
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September 2, 2014, and Patent Owner’s new arguments and evidence
regarding the patentability of claim 17 and the claims that depend therefrom,
as amended, in light of evidence of secondary considerations of non-
obviousness of the subject claims submitted therewith.
The Examiner submitted a Determination under 37 C.F.R. § 41.77(d)
on May 4, 2015 (hereinafter “Determination”).
The Examiner determined that “the response of Patent Owner under
37 C.F.R. 41.77(b)(1) overcomes the [Decisions’] new grounds of
rejection.” Determination 11. The Examiner considers the application of
the teachings of Keller to the amendment to claim 17 and is persuaded that
claim 17, as amended, is patentable over the teachings of Branch, Kossmann
and Kelleher. Determination 13–14.
According to the Examiner,
While it is clear that Kelleher teaches neuromonitoring during a
spinal procedure, Kelleher very clearly does not teach
neuromonitoring during a lateral, trans-psoas spinal procedure.
Kelleher teaches neuromonitoring during a variety of spinal
procedures, such as stimulating the cauda equine and a pedicle
screw test application (see col. 11, lines 5-20 of Kelleher), but
does not teach or suggest using neuromonitoring during a
lateral, trans-psoas approach.
Determination 13–14. The Examiner also finds Patent Owner admits that
“Kelleher discloses using stimulated EMG neuromonitoring techniques in
spinal access applications and the concept has been known for years prior to
the patent under reexamination.” Determination 12. The Examiner further
finds that Patent Owner admits that “all of the applied references, including
Kelleher, are within the field of spinal surgery.” Determination 13.
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Nonetheless, the Examiner reasons that “in order to form the basis for
a tenable combination, Kelleher must provide some suggestion or teaching
to apply the taught neuromonitoring during a lateral trans-psoas spinal
procedure. Kelleher does not.” Determination 14 (citing In re Fine, 837
F.2d 1071 (Fed. Cir. 1988), In re Jones, 958 F.2d 347 (Fed. Cir. 1992), and
KSR International Co. v. Teleflex, Inc., 550 U.S. 398 (2007) for the
proposition that “there must be some teaching, suggestion, or motivation to
do so found either in the references themselves or in the knowledge
generally available to one of ordinary skill in the art”). The Examiner is
further persuaded by Dr. Phillips’ testimony regarding the lack of teaching
in Kelleher as to the specific neural network that comes into play with a
lateral, trans-psoas approach and the special considerations the skilled
artisan would have made regarding these nerves in that approach. Id. at 13–
14 (citing Phillips Decl. ¶¶ 34, 60–63).
The Examiner further considered the Patent Owner’s evidence of
secondary considerations, namely long-felt need, initial skepticism, praise
and recognition, improved patient outcomes, commercial success, and
copying by competitors, presented via the testimony of Dr. Phillips and Dr.
Miles and found this evidence persuasive of non-obviousness. Id. at 14–15.
In response to the Examiner’s Determination, Patent Owner filed
Comments under 37 C.F.R. § 41.77(e) agreeing with the Examiner’s
Determination and identifying additional “ongoing related USPTO
proceedings,” including the issuing of a reexamination certificate in
Reexamination Control No. 95/001,202, regarding U.S. Patent 7,207,949,
and that “Final Written Decisions were issued on April 3, 2015 in inter
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partes review case nos. IPR2014-00034, IPR2014-00073, IPR2014-00074,
IPR2014-00075, IPR2014-00081, and IPR2014-00087.” Comments 1–2.
Third Party Requester, Globus Medical, Inc. (“Requester”) 3 did not
file any Comments under 37 C.F.R. §§ 41.77(c) or 41.77(e). We reconsider
this matter and issue this Final Decision in accordance with 37 C.F.R. §
41.77(f).
For the reasons discussed in detail below, we disagree with
Examiner’s Determination, do not find that Patent Owner’s amendments
overcome the teachings of the prior art, and do not find Patent Owner’s
evidence of secondary considerations persuasive. Accordingly, we maintain
that claims 17–22 and 24–27 are not patentable over the teachings of
Branch, Kossmann, Koros, Kelleher, Michelson, and Tsou.

DISCUSSION
Claim 17 is the sole independent claim on appeal and was not
amended during reexamination. Claim 17 was not amended when
considered during the Decision. Claim 17 as amended in the Patent Owner’s
Request reads as follows (with underlining showing language added in the
Request):
1. A method of accessing a surgical target site within a
spine, comprising the steps of:
(a) creating a distraction corridor along a lateral, trans-
psoas path to a targeted lumbar spinal disc in a lumbar spine
using a distraction assembly comprising at least two dilators
that are sequentially inserted along the lateral, trans-psoas path

3 See Requester’s Appeal Brief 1–2 (filed January 16, 2013) (hereinafter
“Req. App. Br.”).
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to the targeted lumbar spinal disc, and performing
neuromonitoring during at least a portion of the time the
distraction assembly is used in creating the distraction corridor
along the lateral, trans-psoas path, wherein the neuromonitoring
comprises causing the emission of a plurality of electrical
stimulation signals from a stimulation electrode provided on a
distal portion of at least one component of the distraction
assembly and monitoring for resulting electromyographic
(EMG) activity after the emission of each stimulation signal,
and wherein the component of the distraction assembly is
coupled to a control unit of a neuromonitoring system that is
capable of displaying to a user an indication of at least one of
proximity and direction of a nerve to the stimulation electrode
provided on the component of the distraction assembly based
on the monitored resulting electromyographic (EMG) activity;
(b) slidably advancing a plurality of retractor blades of a
retraction assembly along an outermost dilator of the at least
two dilators of the distraction assembly, the retraction assembly
comprising a handle assembly coupled to the plurality of
retractor blades such that the retractor blades extend generally
perpendicularly relative to arm portions of the handle assembly,
each of said plurality of retractor blades having a generally
concave inner face and a generally convex exterior face, said
handle assembly being capable of moving said plurality of
retractor blades from a closed position to an open position, said
closed position being characterized by said plurality of retractor
blades being positioned to about one another and form a closed
perimeter, said open position characterized by said plurality of
retractor blades being positioned generally away from one
another and forming an open perimeter;
(c) simultaneously introducing said plurality of retractor
blades over the outermost dilator of said distraction assembly
along the lateral, trans-psoas path to the targeted lumbar spinal
disc while in said closed position;
(d) actuating said handle assembly to move said plurality
of retractor blades to the open position so that the plurality of
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retractor blades create an operative corridor along the lateral,
trans-psoas path to the targeted lumbar spinal disc;
(e) releasably engaging a fixation element with at least
one of the plurality of retractor blades so that a distal portion of
the fixation element extends distally from the at least one
retractor blade and penetrates into a lateral aspect of the lumbar
spine, wherein the fixation element secures the at least one
retractor blade to the lumbar spine;
(f) inserting an implant through the operative corridor
created by the plurality of retractor blades along the lateral,
trans-psoas path to the targeted lumbar spinal disc.
Request 2–3.

Claim Interpretation
Although we did not expressly construe the phrase “lateral, trans-
psoas path to the targeted lumbar spinal disc” in our prior decision, we do so
now, in view of the Patent Owner’s contentions discussed below and found
persuasive in the Examiner’s Determination.
Patent Owner’s argument are substantially based on the fact that a
“lateral, trans-psoas path to the targeted lumbar spinal disc” necessarily
constitutes a path in which “the lumbar plexus[, which] forms a network of
nerves within the psoas muscle that surgeons considered a no man’s land
and simply avoided.” See Request 18–19 (citing Phillips Decl. 34).
Patent Owner argues that the invention described in the ’057 patent,
for the first time, allowed surgeons to “safely and reproducibly traverse the
psoas” and “avoid the nerve roots in the psoas muscle.” Request 22–23.
We acknowledge again the ’057 patent’s disclosure that its teachings
allow safe and reproducible avoidance of nerves along a lateral, trans-psoas
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path in a fashion that avoids the bony posterior elements of the spinal
column. ’057 patent, col. 12, ll. 41–52. Claim 17, however, does not require
the “trans-psoas path” to pass through any particular portion of the psoas
muscle, nor does the claim require any particular degree or extent of passage
through the psoas. In particular, claim 17 does not require the “trans-psoas
path” to go through the lumbar plexus. In fact, the ’057 patent, is directed to
using neuromonitoring to avoid the lumbar plexus entirely. ’057 patent, col.
12, ll. 41–43 (“provides the ability to actively negotiate around or past such
nerves”); see also Request 9–10: (“NuVasive’s XLIF invention provided for
the first time a safe and reproducible way for spine surgeons to approach the
lumbar spine from a lateral approach and safely traverse the psoas muscle by
using nerve monitoring techniques to avoid nerve structures that reside
within the psoas muscle and are critical to human bodily functions.”)
(emphasis added); Youssef Decl. ¶ 9 (“the lateral, trans-psoas surgical
approach avoids nerves in the psoas muscle, and thus contributes to the safe
and reproducible nature of the NuVasive lateral solution that it provides to
spinal surgeons.”).
The ’057 patent does not expressly define “trans-psoas path.” At best
the ’057 patent states that a “so-called trans-psoas approach” is “a lateral or
far lateral access path.” ’057 patent, col. 2, ll. 31–35. Accordingly, we
conclude that the broadest reasonable interpretation, consistent with the ’057
patent specification, of “trans-psoas path,” encompasses a path that passes
through any portion of the psoas muscle, regardless of the degree or extent
of the passage. See Youssef Decl. ¶ 8 (testifying that ‘“trans-psoas’ is a term
well known within the spinal surgery community, and means going through
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the psoas muscle” and distinguishing only a path in which a surgeon
“retracts the entire psoas muscle”).
As to the “lateral” approach of the trans-psoas path required by claim
17, the ’057 patent refers to a “lateral or far lateral access path (so-called
trans-psoas approach) to the lumbar spine” (’057 patent, col. 2, ll. 31–35),
but the ’057 patent does not expressly define “lateral.” Regarding the
accepted meaning of the term, Patent Owner’s expert, Dr. Youssef, testified
that “laterally” means “(from the side).” Youssef Decl. ¶ 7; see also Phillips
Decl. ¶ 16.
Accordingly, we conclude that the broadest reasonable construction,
consistent with the specification of the ’057 patent, of “lateral, trans-psoas
path to the targeted lumbar spinal disc,” encompasses a path, to the lumbar
spinal disc, which passes through any portion of the psoas muscle, regardless
of the portion, and which is to the lateral side of the body, to any significant
degree, as compared to an anterior puncture.
It is in light of this construction that we examine Patent Owner’s
arguments and evidence.

Claim 17 in view of Branch, Kossmann, Koros, and Kelleher
Patent Owner does not argue that the language added to claim 17
regarding the specific neuromonitoring steps is patentable over the
neuromonitoring device described in Kelleher. To the contrary, Patent
Owner admits that “stimulated EMG neuromonitoring techniques were
known in the surgery arts long before the XLIF technique and ’057
inventions came about (indeed, decades earlier).” Request 11. Rather,
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Patent Owner argues that “Kelleher generally disclosing stimulated EMG
neuromonitoring techniques in spinal access applications, simply did not
suggest to one of skill in the art to apply those techniques in traversing the
psoas muscle.” Request 12.
We disagree with the Examiner that “in order to form the basis for a
tenable combination, Kelleher must provide some suggestion or teaching to
apply the taught neuromonitoring during a lateral trans-psoas spinal
procedure.” Determination 14. In KSR, the Supreme Court set aside any
“rigid” application of the teaching, suggestion, motivation (“TSM”) test,
advising that: “any need or problem known in the field of endeavor at the
time of invention and addressed by the patent can provide a reason for
combining the elements in the manner claimed.” KSR, 550 U.S. at 420. The
Supreme Court clarified that “it can be important to identify a reason that
would have prompted a person of ordinary skill in the relevant field to
combine the elements in the way the claimed new invention does,” but that
“the analysis need not seek out precise teachings [in the prior art] directed to
the specific subject matter of the challenged claim.” Id. at 418.
In the original Decision we determined that:
“[B]ecause each reference [namely, Branch and Kossmann]
teaches the desireability [sic] of avoiding nerves for patient
safety and Kelleher’s neuromonitoring would achieve this, it
would have been obvious to look to a reference such as
Kelleher, which similarly discloses a minimally-invasive spinal
surgical system.” Req. Reb. Br. 11-12. One of ordinary skill in
the art would have recognized the benefit of using a
neuromonitoring system as taught by Kelleher for the purpose
taught by Kelleher, namely “to inform the operator that a
surgical tool or probe is approaching a nerve.” See Request 37.
To do so would have been no more than the predictable use of a
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known neuromonitoring system according to its established
function of detecting nerves during spinal surgery. See KSR,
550 U.S. at 417 (The question to be asked is “whether the
improvement is more than the predictable use of prior art
elements according to their established functions.”).
Decision 15–16. Our reasoning has not changed regarding the application of
Kelleher to proposed claim 17, as amended. Kelleher is not relied upon as
evidence that a trans-psoas path was known in the surgical arts; Kossmann is
relied on for that teaching. It is of no moment that the nerves sought to be
avoided in Kossmann are the iliohypogastric and ilioinguinal nerves,4 these
are still nerves that Kossmann teaches should be avoided in a lateral
approach, which includes the approach taught by Kossmann that involves
splitting the psoas muscle. Kelleher teaches the use of neuromonitoring
techniques in the spinal surgery art to avoid contacting nerves and thus
would be useful for avoiding the nerves taught with respect to the lateral
trans-psoas path described by Kossmann.
Moreover, Patent Owner’s arguments that Kossmann only teaches
traversing a “‘safe zone’ of the psoas muscle[], not a region where the
important lumbar plexus structures typically reside” (Request 11, 16–17) is
consistent with the teachings of the ’057 patent of avoiding the lumbar
plexus nerve root and is encompassed by the scope of a “lateral, trans-psoas
path,” as interpreted above. Indeed, the claims do not recite a step of

4 While we note that Patent Owner’s experts report that the iliohypogastric
and ilioinguinal nerves are not present in the psoas muscle, they are both
considered part of the lumbar plexus and thus consistent with Patent
Owner’s expert testimony that the lumbar plexus was to be avoided in a
trans-psoas approach. See Phillips Decl., Exhibit E (Cunningham’s
Textbook of Anatomy) 791–792 and Exhibit F (Gray’s Anatomy) 277–279.
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avoiding the lumbar plexus or any particular nerves, nor do the claims define
any particular “lateral, trans-psoas path.” Thus, even if Kossmann’s lateral,
trans-psoas path does not implicate the majority of the lumbar plexus nerves,
Kossmann expressly teaches avoiding the iliohypogastric and ilioinguinal
nerves in the lateral approach, including the lateral, trans-psoas approach,
described therein. No additional nerves need be avoided for the prior art to
suggest that the skilled artisan include a step of “performing
neuromonitoring during at least a portion of the time the distraction
assembly is used in creating the distraction corridor along the lateral, trans-
psoas path.”
Unlike the Examiner, we are not persuaded by the unsupported
testimony of Dr. Phillips. For example, Dr. Phillips contends, but does not
explain why, the use of a system for Kelleher would have been suggested for
“a postero-lateral approach where surgical instruments come in close
proximity to the exiting lumbar nerve root” (because it was being used for
this approach) but would not have been suggested for the trans-psoas
approach described by Kossmann, even though it was known in the art at the
time that “the psoas muscle contains a network of important lumbar plexus
nerve structures running through it.” Phillips Decl. ¶¶ 61–63. Similarly, Dr.
Phillips does not support with factual evidence nor explain why “to suggest
that one of skill in the art would have understood that Kelleher has
applicability to any situation where one would want to avoid nerves is
simply an overstatement of what one of skill in the art would have
understood the capability of nerve monitoring to have been at the time.”
Phillips Decl. ¶ 62. To the contrary, on its face, Kelleher teaches the use of
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neuromonitoring to avoid nerves during spinal procedures. Determination
13–14 (finding Kelleher teaches avoiding nerves “during a variety of spinal
procedures”) (citing Kelleher at 11, ll. 5–20); Request 18 (“Kelleher
discloses various new stimulated EMG neuromonitoring techniques, and is
focused more on how stimulated EMG is performed as opposed to particular
applications of the techniques. That said, there are certainly many
applications of the techniques that would have been obvious at the time, and
some of those are described in Kelleher and other NuVasive patents filed
about that time.”). Dr. Phillips’ testimony, without explanation, is
conclusory opinion evidence to which we ascribe little, if any, weight,
particularly when Kelleher teaches neuromonitoring in spinal surgeries
generally. Rohm & Haas Co. v. Brotech Corp., 127 F.3d 1089, 1092 (Fed.
Cir. 1997) (“Nothing in the rules or in our jurisprudence requires the fact
finder to credit the unsupported assertions of an expert witness.”). Patent
Owner has not explained why Kelleher would not have suggested the same
neuromonitoring process for the same purpose, namely avoiding lumbar
plexus nerves, despite the particular approach for which these nerves might
be accessed.
Patent Owner’s arguments, in effect, improperly seek reconsideration
of an already decided issue (see e.g., Request 16–17), in which we already
determined that Kossmann expressly teaches a lateral, trans-psoas approach
for “some very athletic patients.” We decline to revise our position as to that
determination on the present record. Decision 9–10.

Secondary Considerations of Non-obviousness
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Patent Owner contends that objective evidence shows that the claimed
process would not have been obvious to an ordinarily skilled artisan.
Request 12–15. In particular, Patent Owner contends that its surgical
procedure and system solved a long-felt need (id. at 21–23), overcame
significant skepticism (id. at 23–24), elicited significant praise and
recognition among practitioners in the art as being advantageous as
compared to other lumbar surgical techniques (id. at 25–27), experienced
significant commercial success and improved patient outcomes (id. at 27–
30), and was copied by competitors (id. at 30).
Before we conclude whether the challenged claims would have been
obvious, in addition to the teachings in the prior art, “[s]uch secondary
considerations as commercial success, long felt but unsolved needs, failure
of others, etc., might be utilized to give light to the circumstances
surrounding the origin of the subject matter sought to be patented.” Graham
v. John Deere Co., 383 U.S. 1, 17–18 (1966). Such objective indicia of
nonobviousness must be considered “as part of all the evidence, not just
when the decisionmaker remains in doubt after reviewing the art.” Eurand,
Inc. v. Mylan Pharm. Inc. (In re Cyclobenzaprine Hydrochloride Extended–
Release Capsule Patent Litig.), 676 F.3d 1063, 1076–77 (Fed. Cir. 2012)
(citation omitted).
Nexus
“For 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
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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)).
We are not persuaded that the evidence of secondary considerations is
entitled to substantial weight, because Patent Owner has not established a
sufficient nexus between the claimed subject matter and that evidence. We
are also not persuaded that the evidence of secondary considerations is
reasonably commensurate in scope with the claimed subject matter.
Patent Owner focuses on its “XLIF” (“eXtreme Lateral Interbody
Fusion”) system in contending that the claimed process allowed surgeons to
safely and reproducibly traverse the psoas muscle to access the lumbar
spine. Request 22–23. Patent Owner, however, does not establish
adequately what XLIF is and whether it is encompassed by the claim 17 of
the ’057 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 22, and quoting an article that describes features of
XLIF used in conjunction with another Patent Owner product (EMG IOM,
or NeuroVision®), id. at 23 (quoting Miles Decl., Attachment A (Uribe et al.
“Electromyographic Monitoring and Its Anatomical Implications in
Minimally invasive Spine Surgery,” Spine, Vol. 35, No. 265, S368, S370
(2010))). We are unable to discern, from such general evidence, how Patent
Owner is relating the features of XLIF to the claims appealed.
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Patent Owner contends that Dr. Phillips— “a board certified
orthopaedic surgeon—compared XLIF to independent claim 17 of the ’057
patent . . . [and] concluded that the XLIF procedure and systems embody at
least the amended independent claim 17 of the ’057 patent.” Id. at 23.
We acknowledge that Dr. Phillips’s Declaration includes a chart
appearing to map the features of claim 17 of the ’057 patent to the NuVasive
XLIF system and procedure. See Phillips Decl. ¶ 46, Attachment P. Dr.
Phillips cites to Attachment L, which he alternately contends describes the
“XLIF system.” Phillips Decl. ¶ 22, Attachment P. As its title suggests,
however, Attachment L appears to describe a MaXcess II Access System,
with XLIF being one surgical technique performable with this system.
Phillips Decl., Attachment L, at 1. To the extent XLIF is a “system,” it
appears that such a system would not correspond to claim 17 of the ’057
patent. For example, the MaXcess II system includes several surgical
devices, but does not include at least two sequentially inserted dilators with
nerve monitoring capability as claimed. Phillips Decl., Attachment L, at 4.
Rather, Dr. Phillips relies on disclosure of the MaXcess II Access system to
show dilators and disclosure of the separate NeuroVision® System to show
the recited components of the neuromonitoring step of claim 17. Phillips
Decl., Attachment P, at 2–3 (citing Attachment L, at 6, 8). Another portion
of Dr. Phillips’ supporting document details the catalog numbers of the
components of the “XLIF System,” none of which includes dilators with
nerve monitoring capability. Attachment L, at 2. In contrast, dilators are
included in the “MaXcess II Access System,” id. at 24, and nerve monitoring
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appears to be provided by a “NeuroVision JJB System” and disposable
“NeuroVision JJB XLIF Module,” id. at 25.
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. Indeed, there is evidence to suggest that the
“XLIF technique” was not consistent over the relevant time period described
by Patent Owner, but rather was improved both procedurally and
technologically over time. Phillips Decl., Attachment B, at S370 (describing
that in 2010 the XLIF system was in its third generation). Thus, when
Patent Owner uses the shorthand term “XLIF” in its Request, without
clarification, we are unable to associate Patent Owner’s objective evidence
with particular products or features.5 Rather, Patent Owner leaves it to us to
figure out, on a case-by-case basis, what it references by the term “XLIF.”
Indeed, Patent Owner’s Request does not cite to Attachment P, or to
paragraph 46 of Dr. Phillips’ Declaration as evidence of nexus between
NuVasive’s XLIF procedure and the limitations in claim 17.6 Specifically,

5 For example, evidence submitted by Patent Owner states that XLIF is the
invention of Dr. Luiz Pimenta in collaboration with NuVasive, Inc. See e.g.,
Miles Decl., Attachment P; Miles Decl., Attachment K, at 2, last col.; Miles
Decl., Attachment D, 3rd ¶. Yet, Luiz Pimenta is not listed as an identified
inventor of the ’057 patent.
6 In fact, the Request erroneously cites to Attachment E as support for Dr.
Phillips’ testimony. Request 23. Attachment E is an excerpt from
Cunningham’s Textbook of Anatomy, which does not reference NuVasive’s
XLIF system and procedure. The Request also cites to paragraphs 22–23
and 27 of the Phillips Declaration (id.), which describes “what spinal
surgeons were typically doing at the time of the invention instead of a trans-
psoas approach” and which do not cite to any attachments in support of the
statements made therein.
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Patent Owner makes no attempt to explain in its Request how this evidence
establishes a nexus. Instead, it is an improper incorporation by reference of
arguments from the Phillips Declaration into the Request. See 37 C.F.R.
§ 42.6(a)(3) (“Arguments must not be incorporated by reference from one
document into another document.”); DeSilva v. DiLeonardi, 181 F.3d 865,
866–67 (7th Cir. 1999) (rejecting “adoption by reference” as a self-help
increase in the length of the brief and a pointless imposition on the court’s
time as it requires the judges to play archeologist with the record.).
Moreover, Patent Owner acknowledges, the XLIF procedure
“approaches the spine with sequential dilators orthogonal to the disc space in
a true lateral position.” Request 23 (quoting Miles Decl., Attachment A
(Uribe et al. “Electromyographic Monitoring and Its Anatomical
Implications in Minimally invasive Spine Surgery,” Spine, Vol. 35, No. 265,
S368, S370 (2010)). Indeed, evidence advanced by Patent Owner explains
that the XLIF procedure uses “a 90° off-midline or direct lateral approach,”
and advises that it is “imperative that the approach be directly lateral to the
operative level.” Miles Decl., Attachment F (Rodgers et al., “Experience
and Early Results with a Minimally Invasive Technique for Anterior
Column Support Through eXtreme Lateral Interbody Fusion (XLIF®),” US
Musculoskeletal Review: Orthopaedic Surgery Spine (2007)).
Patent Owner distinguishes the XLIF procedure from the purportedly
unpreferred lateral trans-psoas approach taught in the Kossmann reference
which allegedly traverses the psoas muscle via a “safe zone.” Request 11.
Similarly, Patent Owner distinguishes the XLIF procedure from the lateral
trans-psoas approach developed by Dr. Obenchain in the late 1980s and
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early 1990s, which was known to present only “relatively low nerve risk.”
Request 13–14 (citing Phillips Decl. ¶¶ 45–47 (asserting that traversing the
psoas according to teachings of Obenchain reference was done only “out of
necessity” and that the psoas “would have only been incidentally traversed at
its most anterior fibers”) and Attachment D (Obenchain Decl. ¶¶ 7, 13–15).
Yet, as explained above, claim 17 of the ’057 patent is not limited to
the particular approach used in the XLIF procedure, but instead encompasses
any psoas-traversing approach that is lateral to the midline to any significant
degree. Even if we were to find a correspondence between XLIF and the
claims, a critical part of what makes the XLIF procedure unique in the art
and on which Patent Owner primarily relies is not a requirement of the
claims. Claim 17 of the ’057 patent is not limited to XLIF’s approach, and
instead encompasses other lateral trans-psoas approaches to the lumbar
spine, including approaches that Patent Owner acknowledges were known to
present relatively minimal risk of nerve damage, and for which Patent
Owner has advanced no persuasive evidence of non-obviousness. Thus, the
XLIF procedure further is not reasonably commensurate to the scope of the
claims and is not probative to establishing the non-obviousness of the
claimed invention over the other documented prior art approaches that are
also within the scope 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.
Long-felt Need
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“Evidence that an invention satisfied a long-felt and unmet need that
existed on the patent’s filing date is a secondary consideration of
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 ’057 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. Request 12–13. According to Dr.
Phillips, the psoas muscle includes nerve roots that control important bodily
functions and dangerous nerve damage can occur by traversing the psoas
muscle. Id. at 14 (citing Phillips Decl. ¶¶ 18–20). Patent Owner argues that
the locations of these nerves are unpredictable. Request 21–22.
Patent Owner acknowledges, however, that other approaches
conventionally used at the time also had severe drawbacks. Request 13.
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 Phillips
Decl. ¶¶ 39–43). Patent Owner argues that, despite the drawbacks of
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anterior and posterior approaches, they were still preferred to lateral
approaches, illustrating the severity of surgeons’ concerns regarding a
transpsoas approach. Request 12–13, 22. Patent Owner further argues that,
despite this knowledge, surgeons at the time, including Dr. Phillips and Dr.
Obenchain, never considered using nerve monitoring to safely and
reproducibly create a lateral transpsoas approach to the lumbar spine. Id. at
14. Patent Owner also cites to what it characterizes as experimental attempts
to lateral approaches that failed to gain widespread adoption. Id. at 13–15,
22. According to Patent Owner, except for the incidental traversal of the
psoas muscle described in Kossmann (and a similar procedure by
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 but unmet 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. 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. 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). That
those alternative approaches may have presented their own difficulties does
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not persuade us that there was a long-felt but unmet need for the lateral
trans-psoas pathway, absent evidence that widespread efforts by ordinarily
skilled artisans had failed in that trans-psoas approach. See 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.”). Though the evidence
shows concern in the art for the lateral, trans-psoas approach, Kossmann
(and Obenchain) demonstrate success despite such concern, and Patent
Owner concedes that even those efforts were not widespread in the art, but
instead involved no more than “a small handful of patients.” Request 22.
Had there been a strong and long-felt need in the art at the time of the
invention, efforts would have been focused on improving the lateral trans-
psoas approach. Instead, other approaches were routinely adopted. Id.
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 ’057 patent. To show that such a need was met, Patent Owner relies on
its XLIF procedure, which uses nerve monitoring to safely traverse the
“main body of the psoas muscle” in an extreme lateral approach. Request 14
(citing Phillips Decl., Attachment D (Obenchain Decl. ¶¶ 14-15)
(distinguishing XLIF’s traversing the “main body of the psoas muscle” from
Obenchain’s own prior art traversing the psoas muscle via an “extreme
medial” portion of the psoas muscle)) and 22-23. As explained above,
Patent Owner’s evidence does not establish a nexus between XLIF (or an
extreme lateral approach) and the claims, which require no such extreme
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approach. Thus, Patent Owner’s arguments are not probative to whether or
not claim 17, as amended to include neuromonitoring, is non-obvious, but
rather addresses the obviousness of issues already determined in our prior
Decision.
Accordingly, we are not persuaded by Patent Owner’s evidence of
long-felt need or its product’s satisfaction of such a need.
Skepticism Followed by Praise and Recognition
Skepticism that a patented device would work, followed by
widespread acceptance and praise, can evince 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 result in
neurological injury to the patient. Request 23 (citing Phillips Decl. ¶¶ 28–33
and Miles Decl. ¶¶ 12–15). Much of this evidence consists of personal
recollections of Dr. Phillips, including his recollections of conversations he
had with surgeons (including those working for Petitioner) in the 2003–2006
time frame as well as his review of deposition transcripts in related
litigation. Request 23–24 (citing Phillips Decl. ¶¶ 28–30). Patent Owner
also cites Dr. Obenchain, who testifies that he would have been skeptical at
that time of “safely passing through the main body of the psoas muscle” or
taking “a pure lateral approach.” Id. at 24 (citing Phillips Decl., Attachment
D (Obenchain Decl. ¶¶ 14–15, 21)).
The objectivity of this evidence is questionable, as both Dr. Phillips
and Dr. Obenchain are paid consultants to Patent Owner and are testifying
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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) (“The 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. The evidence relied upon by the Patent Owner is probative only to
the issue of whether the extreme lateral, trans-psoas path of NuVasive’s
XLIF system would have been safe and reproducible. Even according to
Patent Owner’s experts, the less extreme lateral, trans-psoas path taught by
Kossmann was recognized as relatively safe.
As to eventual acceptance and praise, Patent Owner introduces
evidence, including the recollection of Mr. Miles, an executive of Patent
Owner, that one-by-one, surgeons stopped doubting XLIF and began to
adopt it. Request 25–27 (citing Miles Decl. ¶¶ 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. Request
25–27. Much (but not all) of this evidence was funded by Patent Owner
and/or was written by paid consultants of NuVasive, Inc., namely L.M.
Pimenta, W.B. Rodgers, and A.G. Tohmeh. See, e.g., Phillips Decl.,
Attachment B, at 2 (NuVasive funded special Spine edition); Phillips Decl.,
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Attachment I (Park, et al., “The Relationship of Intrapsoas Nerves During a
Transpsoas Approach to the Lumbar Spine,” J. Spinal Disord. Tech., Vol.
23, No. 4, 223 (June 2010)), at 228; Phillips Decl., Attachment H (Tohmeh
et al., “Dynamically evoked, discrete-threshold electromyography in the
extreme lateral interbody fusion approach,” J. Neurosurg: Spine (December
17, 2010)), at 6; Miles Decl., Attachment C (SOLAS News, Issue 10 (April
2010)), at 8; Miles Decl., Attachment S (The Better Way Back Book
(2010)), at 5. 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 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. Request 27–28. However,
this evidence discusses the benefits of XLIF generally and substantially only
in comparison to “open-spine surgery,” i.e., the midline anterior or posterior
approach. The disadvantages of these approaches were known at the time of
the invention. The benefits to a patient of a less invasive lateral approach
over a more invasive open-spine surgery are not surprising or unexpected.
At the time of the invention, the benefits to a less invasive lateral approach
were known in the art. See Kossmann, at 293; Phillips Decl., Attachment D
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(Obenchain Decl. ¶¶ 14, 18 (describing an anterolateral approach medial to
the psoas muscle or through a very medial portion of the psoas muscle and a
posterolateral approach as “preferred” over a posterior or anterior
approach)), and Attachment K (McAfee et al., “Minimally Invasive Anterior
Retroperitoneal Approach to the Lumbar Spine,” Spine, Vol. 23, No. 65
(1998), at 1483); Phillips Decl., Attachment J (U.S. Patent 4,545,374 to
Jacobson), at col. 2, ll. 16–62. See also U.S. Patents 5,195,541 and
5,313,962 to Obenchain (describing lateral approaches to the lumbar spine).
Thus, better patient outcomes from a minimally invasive approach over an
open-spine approach are not unexpected or surprising, as argued by Patent
Owner.
Further, Patent Owner directs us to no testimonials that discuss the use
of nerve monitoring to traverse the psoas muscle or any other features of the
claims. We note only one statement mentioning “strict adherence to surgical
technique including neuromonitoring” (Miles Decl., Attachment G (Malham
et al., “Clinical Outcome and Fusion Rates after the First 30 Extreme Lateral
Interbody Fusions,” Sci. World J., Vol. 2012, Article ID 246989 (2012)), at
57).
In any case, as explained above, Patent Owner has not shown a nexus
between XLIF and the claims.
Commercial Success

7 Even this reference identifies L. Pimenta, a paid consultant and shareholder
for NuVasive, Inc., as an “Academic Editor,” drawing into question the
independent nature of these statements. See Miles Decl., Attachment G, at
1.
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Patent Owner argues that NuVasive has grown from the garage of Dr.
James Marino in 1999 to “the third largest spine company in the U.S. and
the fourth largest globally, employing more than 1300 people.” Request 28
(citing Miles Decl. ¶¶ 7, 9, 12, 25, 28). According to Patent Owner, its
“meteoric growth” has been “a direct result of its XLIF procedure and
systems and the claimed technology.” Id. at 29 (citing Miles Decl. ¶¶ 24–
29). In support, Patent Owner and Dr. Miles rely on reports of market
research from financial analysts crediting its success, at least in part, to
XLIF. Id. at 29–30; Miles Decl., Attachment U, at 289 (“The majority of
NuVasive’s revenue is directly related to the XLIF procedure and its related
devices”); Miles Decl., Attachment AC, at 1, 3 (J.P. Morgan report
attributing success to Maximum Access Surgery (MAS) platform, XLIF,
NeuroVision®, and heavy salesforce investment); Miles Decl., Attachment
W, at 12 (Canaccord Genuity report attributing success to the “critical
component” NeuroVision® and MaXcess retractor system); Miles Decl.,
Attachment AD, at 3 (Caris & Co. report stating, inter alia, that “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 launched its
Inter-operative Nerve monitoring system (NVJJB/M5).”).
“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 above, Patent Owner has not shown a correspondence between
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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 “[t]he novel
combination found in NuVasive’s neuromonitoring enabled
distraction/retraction system as claimed in the ’057 patent has resulted in
XLIF and NuVasive being commercially successful.” Request 28. Yet,
much of Patent Owner’s evidence attributes commercial success to being the
first system that allowed for a lateral spinal approach that could be
reproduced safely. Request 29 (quoting Miles Decl., Attachment AD, at 3–4
(“XLIF..., unlike more traditional methods, access to the spinal area to be
fused is done through a lateral (i.e., the side)—as opposed to posterior (i.e.
back) or anterior (i.e. front) approach.”)). Meanwhile, the closest prior art,
namely Kossmann, teaches that a lateral approach falling within the scope of
the claims was known in the art at the time of the invention and known to be
capable of being performed safely, i.e., in “the safe zone,” even without
neuromonitoring.
Patent Owner’s evidence shows that at least some of the reported
commercial success resulted, at least in part, from factors not associated with
either the claims or the techniques or hardware of XLIF. Specifically, 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:
Revenues. 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
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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.
Miles Decl., Attachment AA, at 69 (emphasis added). Thus, even if Patent
Owner were able to show that XLIF embodies the claims of the ’057
patent, the auxiliary products other than XLIF were the primary drivers of
Patent Owner’s commercial success because the procedure recited in the
’057 patent, namely the “nerve monitoring systems and surgical
instrument sets” were “loan[ed] at no cost to surgeons.” Id.
Patent Owner’s evidence also shows that the adoption of
NuVasive’s products was influenced by an aggressive campaign to have
spinal surgeons around the country (and around the world) observe
procedures using NuVasive’s products first hand. Request 25; Miles
Decl. ¶¶ 14(“NuVasive put substantial resources into educating the spinal
community to over that skepticism and show that XLIF was indeed a safe
and effective solution for spinal fusion.”) and 16 (“Through NuVasive’s
education efforts, surgeons began adopting XLIF into their practices.”).
Patent Owner also argues that XLIF created an entirely new market
segment. Request 28. In support, Patent Owner points to documents from
Requester referring to a “minimally invasive fusion market” (Miles, Decl.,
Attachment X, at 8). It is unclear precisely what types of surgery these
particular markets include. For example, Attachment X to Miles’
Declaration shows Requester as having a larger share of the “minimally
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invasive fusion market” than Patent Owner from the year 2005 to 2008,
which does not support the Patent Owner’s contention. Id. Thus, the
evidence Patent Owner presents is not sufficient to ascertain what is
included in the markets to which Patent Owner refers. Claim 17 of the ’057
patent is directed generally to “[a] method of accessing a surgical target site
within a spine” and includes a step of “inserting an implant . . . to the
targeted lumbar spinal disc,” and is not limited to use in “minimally
invasive fusion.” Thus, Patent Owner has not shown that its evidence
directed to market share in a small fraction of spinal surgery is
commensurate with the scope of the claims.
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 ’057 patent claims.
Copying
Patent Owner contends that Petitioner and other competitors copied
its XLIF technology. Request 30. According to the Federal Circuit,
[C]opying 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, citing a financial analyst report (from J.P. Morgan)
argues that other competitors introduced competing products and, thus,
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copied XLIF. Id. (citing Miles Decl., Attachment AE, at 1). This evidence
lacks sufficient detail to determine whether the competing products practice
the claims or ascertain whether they were copied from XLIF. Patent
Owner’s evidence is entirely silent as to the structure or function of the
allegedly competing products.
In sum, Patent Owner’s evidence does not show efforts by Requester,
or others, to replicate XLIF. Accordingly, we are not persuaded that
objective indicia of copying evidences non-obviousness.
Conclusion of Obviousness
As explained above, the prior art teaches each limitation of amended
claim 17. Requester introduced persuasive evidence that a skilled artisan
would have had reasons to combine the prior art to arrive at these claims,
which is supported by rational underpinnings. See Decision 14–16 and
above. We have weighed the rationale based on the prior art 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 Patent
Owner’s objective indicia of non-obviousness, we conclude by a
preponderance of the evidence that claim 17 as amended and the claims that
depend therefrom would have been obvious over Branch, Kossmann,
Koros, Kelleher, Michelson, and Tsou, in accordance with our prior
Decision’s discussion of claims 19–22 and 27 and for the reasons discussed
above.

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PATENT OWNER:
WILSON, SONSINI, GOODRICH & ROSATI
650 Page Mill Road
Palo Alto, CA 94304-1050

THIRD-PARTY REQUESTER:

Jay Guiliano, Esq.
NOVAK DRUCE & QUIGG LLP
300 New Jersey Ave., NW
Fifth Floor
Washington, DC 20001