Medtronic, Inc.v.NuVasive, Inc.

Patent Trial and Appeal Board

Feb 11, 2015

13441092 (P.T.A.B. Feb. 11, 2015)

Trials@uspto.gov Paper No. 47
571.272.7822 Filed: February 11, 2015

UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

MEDTRONIC, INC.,
Petitioner,
v.
NUVASIVE, INC.,
Patent Owner.
____________________

Case IPR2013-00506
Patent 8,361,156 B2
___________________

Before SALLY C. MEDLEY, LORA M. GREEN, and STEPHEN C. SIU,
Administrative Patent Judges.

GREEN, Administrative Patent Judge.

FINAL WRITTEN DECISION
35 U.S.C. § 318(a) and 37 C.F.R. § 42.73

I. INTRODUCTION
A. Background
Petitioner, Medtronic, Inc. (“Medtronic”), filed a Petition requesting
inter partes review of claims 1–14, 19, 20, and 23–27 (“the challenged
claims”) of U.S. Patent No. 8,361,156 B2 (“the ’156 patent”). Paper 1
(“Pet.”). Patent Owner, NuVasive, Inc. (“NuVasive”), filed a Patent Owner
IPR2013-00506
Patent 8,361,156 B2

2
Preliminary Response. Paper 8. We determined that the information
presented in the Petition and the Preliminary response demonstrated that
there was a reasonable likelihood that Petitioner would prevail in
challenging claims 1–14, 19, 20, and 23–27 as unpatentable under 35 U.S.C.
§ 103(a). Pursuant to 35 U.S.C. § 314, the Board instituted trial on February
13, 2014 , as to the challenged claims of the ’156 patent. Paper 9
(“Institution Decision”; “Dec. Inst.”).
Patent Owner filed a Response (Paper 21, “PO Resp.”), but did not
file a motion to amend. Petitioner subsequently filed a Reply. Paper 28
(“Reply”). An oral hearing was held on November 18, 2014. The transcript
of the hearing has been entered into the record. Paper 46. Patent Owner
also filed a Corrected Motion for Observation on certain cross-examination
testimony of Petitioner’s declarant, Richard A. Hynes, M.D. (Paper 38,
“Hynes Obs.”) and a Corrected Motion for Observation on certain cross-
examination testimony of Petitioner’s declarant, Loic Josse (Paper 39, “Josse
Obs.”). Petitioner filed a Response to each of Patent Owner’s Motions for
Observation (Paper 44, “Hynes Obs. Resp.”; Paper 43, “Josse Obs. Resp.”).
We have jurisdiction under 35 U.S.C. § 6(c). This final written
decision is issued pursuant to 35 U.S.C. § 318(a) and 37 C.F.R. § 42.73.
Based on the record before us, we conclude that Petitioner has demonstrated
by a preponderance of the evidence that claims 1–14, 19, 20, and 23–27 of
the ’156 patent are unpatentable.
B. Related Proceedings
Medtronic filed concurrently another petition for an inter partes
review of the ’156 patent, IPR2013-00504, in which we declined to institute
inter partes review. IPR2013-00504, Paper 8. Petitioner subsequently filed
IPR2013-00506
Patent 8,361,156 B2

3
another petition for an inter partes review, IPR2014-00487, in which we
also declined to institute inter partes review. IPR2014-00487, Paper 8.
Medtronic indicates further that it is a named counterclaim-defendant
in the district court action titled Warsaw Orthopedic, Inc. v. NuVasive Inc.,
Case No: 3:12-cv-02738-CAB-MDD (S.D. Cal.), which also involves the
’156 patent. Pet. 1.

C. The ’156 Patent (Ex. 1115)
The ’156 patent issued on January 29, 2013, with Matthew Curran and
Mark Peterson as the listed co-inventors. The ’156 patent is drawn to a
spinal implant, and methods of spinal fusion using the implant. Ex. 1115,
1:20–24. A spinal fusion procedure generally involves removing some or all
of a diseased spinal disc, and inserting an intervertebral implant into the disc
space. Id. at 1:30–33. The spinal fusion implant is introduced into the disc
space via a lateral approach to the spine, or via a posterior, anterior, antero-
lateral, or postero-lateral approach, depending on the size of the implant. Id.
at 5:29–35. As taught by the ’156 patent, the implant is made from a
material “having suitable radiolucent characteristics,” such as PEEK (poly-
ether-ether-ketone). Id. at 5:10–15.
The ’156 patent teaches further that the implant “may be provided in
any number of suitable shapes and sizes depending on the particular surgical
procedure or need,” and that it “may be dimensioned for use in the cervical
and/or lumbar spine.” Id. at 2:12–16. Thus, before a spinal fusion
procedure is performed, “the clinician must first designate the appropriate
implant size.” Id. at 11:10–12.

IPR2013-00506
Patent 8,361,156 B2

4
D. Illustrative Claim
Petitioner challenges claims 1–14, 19, 20, and 23–27 of the ’156
patent. Claims 1, 5, and 9 read as follows:
1. A spinal fusion implant of non-bone construction positionable
within an interbody space between a first vertebra and a second
vertebra, said implant comprising:

an upper surface including anti-migration elements to contact
said first vertebra when said implant is positioned within the interbody
space, a lower surface including anti-migration elements to contact
said second vertebra when said implant is positioned within the
interbody space, a distal wall, a proximal wall, a first sidewall, and a
second sidewall generally opposite from the first sidewall, wherein
said distal wall, proximal wall, first sidewall, and second sidewall
comprise a radiolucent material;

wherein said implant has a longitudinal length extending from a
proximal end of said proximal wall to a distal end of said distal wall,
said implant has a maximum lateral width extending from said first
sidewall to said second sidewall along a medial plane that is generally
perpendicular to said longitudinal length, and said longitudinal length
is greater than said maximum lateral width;

at least a first fusion aperture extending through said upper
surface and lower surface and configured to permit bone growth
between the first vertebra and the second vertebra when said implant
is positioned within the interbody space, said first fusion aperture
having: a longitudinal aperture length extending generally parallel to
the longitudinal length of said implant, and a lateral aperture width
extending between said first sidewall to said second sidewall, wherein
the longitudinal aperture length is greater than the lateral aperture
width; and

at least first and second radiopaque markers oriented generally
parallel to a height of the implant, wherein said first radiopaque
marker extends into said first sidewall at a position proximate to said
IPR2013-00506
Patent 8,361,156 B2

5
medial plane, and said second radiopaque marker extends into said
second sidewall at a position proximate to said medial plane.

5. The spinal fusion implant of claim 1, further including at least one
receiving aperture position at said proximal wall wherein said
longitudinal length is greater than 40 mm.

9. The spinal fusion implant of claim 1, wherein said maximum lateral
width of said implant is approximately 18 mm.
E. Instituted Challenges
Claims Basis References
1–4, 7, 8, 10–14, 19, 20,
23, 24, 26, and 27 § 103(a) SVS
1 and Baccelli2
5, 6, and 9 § 103(a) SVS, Baccelli, and Michelson3
25 § 103(a) SVS, Baccelli, and Telamon4
1–4, 7, 10–14, 19, 20, and
23–27 § 103(a) Telamon and Baccelli
5, 6, 8, and 9 § 103(a) Telamon, Baccelli, and Michelson

II. ANALYSIS
A. Claim Construction
In an inter partes review, claim terms in an unexpired patent are
interpreted according to their broadest reasonable construction in light of the

1 Synthes Vertebral Spacer – PR Brochure, Synthes Spine 2002 (“SVS”,
Ex. 1106).
2 Baccelli, US 2003/0028249 A1, filed February 6, 2003 (Ex. 1104).
3 Michelson, US 5,860,973, issued January 19, 1999 (Ex. 1105).
4 Medtronic Sofamor Danek, Telamon, Verte-Stack PEEK Vertebral Body
Spacer, ©2003 Medtronic Sofamor Danek USA, Inc (Ex. 1107); and
Telamon, Posterior Impacted Devices, ©2003 Medtronic Sofamor Danek
USA, Inc. (Ex. 1108) (collectively, “Telamon”).
IPR2013-00506
Patent 8,361,156 B2

6
specification of the patent in which they appear. 37 C.F.R. § 42.100(b);
Office Patent Trial Practice Guide, 77 Fed. Reg. 48,756, 48,766
(Aug. 14, 2012). Claim terms also are given their ordinary and customary
meaning, as would be understood by one of ordinary skill in the art in the
context of the entire disclosure. In re Translogic Tech., Inc., 504 F.3d 1249,
1257 (Fed. Cir. 2007). If an inventor acts as his or her own lexicographer,
the definition must be set forth in the specification with reasonable clarity,
deliberateness, and precision. Renishaw PLC v. Marposs Societa’ per
Azioni, 158 F.3d 1243, 1249 (Fed. Cir. 1998).
In the Institution Decision, we “interpret[ed] the claim language
consistently with its plain and ordinary meaning, when read in view of the
Specification.” See, e.g., Dec. Inst. 6. The parties appear to agree on the
interpretation of the claim terms, and we see no reason to depart from our
interpretation in the Institution Decision.
B. Patentability
1. Principles of Law
To prevail on its challenges to the patentability of claims, Petitioner
must prove unpatentability by a preponderance of the evidence. 35 U.S.C.
§ 316(e); 37 C.F.R. § 42.1(d).
A claim is unpatentable under 35 U.S.C. § 103(a) if the differences
between the subject matter sought to be patented and the prior art are such
that the subject matter as a whole would have been obvious at the time the
invention was made to a person having ordinary skill in the art to which said
subject matter pertains. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 406
(2007). The question of obviousness is resolved on the basis of underlying
factual determinations including: (1) the scope and content of the prior art;
IPR2013-00506
Patent 8,361,156 B2

7
(2) any differences between the claimed subject matter and the prior art;
(3) the level of ordinary skill in the art; and (4) objective evidence of
nonobviousness. Graham v. John Deere Co., 383 U.S. 1, 17–18 (1966).
The level of ordinary skill in the art usually is evidenced by the references
themselves. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir.
2001); In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995); In re Oelrich,
579 F.2d 86, 91 (CCPA 1978).
Prior art references must be “considered together with the knowledge
of one of ordinary skill in the pertinent art.” In re Paulsen, 30 F.3d 1475,
1480 (Fed. Cir. 1994) (quoting In re Samour, 571 F.2d 559, 562 (CCPA
1978)). Moreover, “it is proper to take into account not only specific
teachings of the reference but also the inferences which one skilled in the art
would reasonably be expected to draw therefrom.” In re Preda, 401 F.2d
825, 826 (CCPA 1968). That is because an obviousness analysis “need not
seek out precise teachings directed to the specific subject matter of the
challenged claim, for a court can take account of the inferences and creative
steps that a person of ordinary skill in the art would employ.” KSR, 550 U.S.
at 418; see In re Translogic Tech., Inc., 504 F.3d. 1249, 1259 (Fed. Cir.
2007).
2. Obviousness of Claim 1 under 35 U.S.C. § 103(a) Over One
of SVS or Telamin, Combined with Baccelli
Petitioner contends that the combination of one of SVS or Telamon
with Baccelli renders obvious independent claim 1. Pet. 14–16; 38–39.
Petitioner sets forth claim charts demonstrating where each element of the
claim is taught by the reference (Id. at 16–18; 39–42), and relies, initially, on
the Declaration of Dr. Hynes (Ex. 1101). Patent Owner disagrees with
Petitioner’s assertions (PO Resp. 32–47), and relies on the Declaration of
IPR2013-00506
Patent 8,361,156 B2

8
Dr. Hansen A. Yuan (Ex. 2020) as evidence that the asserted combination
does not render obvious the challenged claims.
a. SVS (Ex. 1106)
SVS discloses a vertebral spacer (or spinal implant) made of a
radiolucent polymer that allows fusion to occur through the implant. In one
embodiment, the implant measures 22 mm depth by 8 mm width and
includes two radiopaque marker pins. Ex. 1106, 1–2.

b. Telamon (Ex. 1107)
Telamon discloses a radiolucent spinal implant measuring 22-26 mm
length by 10 mm width. Ex. 1107, p. 2. The implant further includes
radiographic markers. Id.
c. Baccelli (Ex. 1104)
Baccelli discloses an intervertebral implant. Ex. 1104 ¶ 1. The
implant has a front wall (id. ¶ 6, Fig. 8 – element 4b) that contains an orifice
(id. ¶ 39, Fig. 8, element 18) into which a threaded endpiece is connected for
placing the implant into position between vertebrae. Id. ¶¶ 44–45.
The implant is made of a material that is transparent to X-rays, such as
PEEK. Id. ¶ 50. One or more markers that are opaque to X-rays may be
used to identify the position and/or the presence of the implant when X-rays
are taken. Id. The radiopaque markers may be positioned within the
anterior (i.e., proximal) wall and/or the posterior (i.e., distal) wall of the
implant. Id. at Figs. 1–4, 8, 9.
The implant may further include spikes positioned symmetrically
about the sagittal midplane and extending in the frontal midplane in a
IPR2013-00506
Patent 8,361,156 B2

9
vertical axis. Id. ¶ 41, Figs. 1–5, 8, 9. The spikes may be made of a
radiopaque material (i.e., a material that is opaque to X-rays). Id. ¶ 51.
d. Analysis
Petitioner asserts that SVS and Telamon disclose almost all the
limitations of independent claim 1. Pet. 14–15, 38. The SVS and Telamon
implants have radiopaque markers in their distal and proximal walls. Id at
15, 38. Petitioner asserts that Baccelli also teaches the use of radiopaque
markers, wherein the “at least first and second radiopaque markers . . .
extend into a first sidewall and a second sidewall at positions proximate to a
medial plane of the implant.” Id. at 15, 39.
According to Petitioner, it would have been obvious to the ordinary
artisan at the time of invention to include the radiopaque markers of Baccelli
in the implants of SVS or Telamon in order to provide additional
information regarding the location and/or orientation of the implant, both
during surgery and after implantation. Id. at 15, 39 (citing Ex. 1101 ¶ 68).
Petitioner contends further that such a combination is “nothing more than an
application of known prior art elements to improve a similar device in the
same way.” Id. at 15, 39.
Patent Owner contends that neither Telamon nor SVS disclose an
interbody fusion implant “with radiopaque markers in the medial plane.”
PO Resp. 33. Patent Owner contends further that the implant designed by
Dr. Hynes, the Saber implant, does not include radiopaque markers in the
medial plane. Id. (citing Ex. 2011; Ex. 2020 ¶ 95). Rather, the markers are
only at the proximal and distal ends. Id. at 33–34. Thus, Patent Owner
contends, “it is plainly apparent that the implant designers for each of
Medtronic, Synthes, and DePuy Spine all considered radiopaque markers to
IPR2013-00506
Patent 8,361,156 B2

10
be inappropriate or at least unnecessary in the medial plane for PLIF
[posterior lumbar interbody fusion] implants.” Id. at 34 (citing Ex. 2020
¶¶ 45, 98–99, and 102). We are not persuaded by Patent Owner’s argument,
because the question is whether it would have been obvious to one of
ordinary skill in the art to combine the cited references, and not whether any
specific implants on the market contain a radiopaque marker in a central
region.
Patent Owner contends further that none of the references relied upon
by Petitioner provide a reason to add a pair of radiopaque markers to the
medial plane of a PLIF implant, such as those of Telamon and SVS. Id. at
36 (citing Ex. 2020 ¶¶ 89, 98, 99). Patent Owner argues that the reason
articulated by Petitioner’s expert, Dr. Hynes, of providing additional
information “is simply a vague explanation with no rational underpinning.”
Id. at 37 (citing Ex. 1101 ¶ 68). In particular, Patent Owner contends that
Dr. Hynes “does not provide a rational explanation for what ‘additional
information’ and certainly does not cite any evidence that what he proposes
was ‘common sense’ in 2004 or ever.” Id. at 37–38. Patent Owner argues
that any information provided by adding markers to the medial plane would
be at best redundant, or at worst, a possible source of confusion. Id. at 38.
Dr. Hynes, Patent Owner contends, engaged in impermissible hindsight to
combine Bacelli with SVS and Telamon to arrive at an implant having
radiopaque markers at the medial plane. Id. at 38–40.
Patent Owner contends that the ordinary artisan would not have added
markers to the medial plane “because doing so would add no meaningful
‘additional information’ beyond that already provided by the existing
markers and would increase the likelihood of causing confusion.” Id. at 49
IPR2013-00506
Patent 8,361,156 B2

11
(citing Ex. 2020 ¶¶ 98–99). Patent Owner cites their expert, Dr. Yuan, in
arguing that the “conventional and proper position for radiopaque markers in
PLIF implants is at the proximal and distal ends,” as they allow the surgeon
to determine the location and orientation of the PLIF implant in PLIF
implantation procedures. Id. at 40–41 (citing Ex. 2020 ¶¶ 45, 98, 99). Thus,
having markers as the proximal and distal walls provides all the information
necessary for both during and after the surgery. Id. at 42.
Moreover, according to Patent Owner, Petitioner’s expert, Dr. Hynes,
testified that markers in the wrong place may actually create confusion. Id.
at 43 (citing Ex. 2013, 163:23–164:25). “Every excess marker increases the
risk of confusing one marker for another,” and, thus, “designers are very
purposeful about the number and location of markers added to fusion
implants.” Id. at 44 (citing Ex. 2020, ¶¶ 45–46, 98, 99).
We do not find Patent Owner’s arguments persuasive. As Petitioner
notes (Reply 11), Baccelli teaches the use of radiopaque markers in the
central regions of an implant. See Ex. 1104 ¶¶ 41, 51; Figs. 1–5, 8, 9. We
also agree with Petitioner that the addition of markers along the medial plan
would not confuse a surgeon of ordinary skill in the art, and “vastly
underestimates the ordinary skill of surgeons in this field.” Reply 11 (citing
Ex. 1104, FIG. 2; Ex. 1129).
In that regard, we credit the testimony of Patent Owner’s Declarant,
Dr. Yuan, that one of ordinary skill in the art would have understood that an
implant that “includes two radiopaque markers in the central region [would
provide] . . . better align[ment of] the implant” and “also allows a surgeon to
see in an anterior-to-posterior x-ray view whether the implant is askew and
the degree to which the implant is askew.” Ex. 2020 ¶ 60. Given the
IPR2013-00506
Patent 8,361,156 B2

12
relative level of skill in the art, we agree with Dr. Yuan that the use of
markers to improve x-ray visualization of the alignment of implants, for
example, would have been well within the purview of one of ordinary skill
in the art at the time of the invention.
We note that Dr. Yuan testified that one “complication with using
markers . . . is that the implant can have too many of them” (Ex. 2020 ¶ 45),
and testified also that the use of a radiopaque marker in the central region of
an implant “could cause problems, including confusing the surgeon” (Ex.
2020 ¶ 98). Dr. Yuan, however, provides insufficient evidence in support of
this contention. For example, Dr. Yuan does not provide persuasive
evidence supporting the contention that problems would arise in the use of a
radiopaque marker in the central region of an implant, the nature and extent
of any potential problems, or how any such problems would confuse a
surgeon of ordinary skill in the art and to what extent. Indeed, as previously
discussed, Baccelli discloses radiopaque markers in the central region of an
implant, and does not disclose that one of ordinary skill in the art is confused
by such an arrangement.
As to Patent Owner’s argument that Petitioner’s Declarant, Dr.
Hynes), testified that it would not have been obvious to one of ordinary skill
in the art to have incorporated a radiopaque marker in the central region of
an implant because doing so may cause confusion, Dr. Hynes merely
testifies that using “the wrong marker” in “the wrong place” may “create[]
confusion sometimes.” Ex. 2013, 164:11, 12–13. As already noted,
however, Baccelli discloses the use of such a marker in the central region of
an implant, thus suggesting to one of ordinary skill in the art that such a
IPR2013-00506
Patent 8,361,156 B2

13
marker would not have been “wrong” and that the central region would not
have been a “wrong place” for such a marker.
Hence, we are not persuaded by Patent Owner’s contention that the
addition of pair of radiopaque markers to the medial region of an implant
would not add any meaningful information and would cause confusion.
Patent Owner contends further that neither Telamon nor SVS disclose
an interbody fusion implant with elongate metal fixation spikes, such as
those taught by Baccelli, and that the Saber implant designed by Dr. Hynes
also did not incorporate such spikes. PO Resp. 34. According to Patent
Owner, such spikes “would hinder or interfere with the intended PLIF usage
of those implants.” Id. That is, Patent Owner argues, as the Medtronic,
Synthese, and DePuy Spine did not incorporate such spikes, it is “plainly
apparent” that the designers “considered such metal fixation spikes to be
inappropriate for the PLIF implant.” Id. at 35. Thus, Patent Owner argues,
the ordinary artisan would not have included the metal spikes of Baccelli on
the implants of SVS or Telamon. Id. at 46.
Petitioner responds that the disclosure of Baccelli was not relied upon
for the disclosure of spikes, but for locating radiopaque markers along the
medial plane. Reply 12. We agree with Petitioner that the ordinary artisan
would understand from the disclosure of Baccelli that radiopaque markers
could be also located at the medial plane of the implant. “The test for
obviousness is not whether the features of a secondary reference may be
bodily incorporated into the structure of the primary reference; nor is it that
the claimed invention must be expressly suggested in any one or all of the
references. Rather, the test is what the combined teachings of the references
IPR2013-00506
Patent 8,361,156 B2

14
would have suggested to those of ordinary skill in the art.” In re Keller, 642
F.2d 413, 425 (CCPA 1981) (citations omitted).
3. Obviousness of Claims 5 and 9 under 35 U.S.C. § 103(a)
Over One of SVS or Telamin, Combined with Baccelli and
Michelson
a. Michelson
The disclosures of SVS, Telamon, and Baccelli are discussed above as
to the challenge of claim 1. Michelson discloses a translateral spinal fusion
implant. Ex. 1105, 5:44-45. In one embodiment, the implant has “a length
in the range of 32 mm to 50 mm, with 42 mm being the preferred length.”
Id. at 10:46-47. The implant may also have “a maximum diameter in the
range of 14-26 mm, with the preferred diameter being 20 mm.” Id. at 7:28-
30.
b. Claims 5 and 9
Petitioner contends that the combination of SVS or Telamon with
Baccelli and Michelson renders obvious claims 5 and 9. Pet. 21–24, 27–29,
45–49, 52–53. Petitioner sets forth a claim chart demonstrating where each
element of the claims is taught by the reference (id. at 25–26, 29, 49–50, 53),
and relies, initially, on the Declaration of Dr. Hynes (Ex. 1101). Patent
Owner disagrees with Petitioner’s assertions (PO Resp. 47–59), and relies on
the Declaration of Dr. Yuan. (Ex. 2020) as evidence that the asserted
combination does not render obvious the challenged claims.
Specifically, as to the limitation of claim 5 that the longitudinal length
is greater than 40 mm, Petitioner relies on Michelson for its disclosure of a
spinal fusion implant that may have a longitudinal length greater than 40
mm. Pet. 22, 47. According to Petitioner, it would have been obvious to the
ordinary artisan to include a longitudinal length greater than 40 mm to the
IPR2013-00506
Patent 8,361,156 B2

15
SVS or Telamon implant, as the implant would span the disc space and
provide for more stable support. Id. at 22, 47 (Ex. 1101 ¶ 81). Petitioner
contends that increasing the length of the SVS or Telamon implant would
involve nothing more than routine optimization, requiring only the “exercise
of ordinary skill and common sense to apply an identified, predictable
solution to a known design need.” Id. at 24, 49.
Claim 9 adds the limitation that the maximum lateral width of the
implant is approximately 18 mm. Petitioner relies on Michelson’s teaching
of an implant having a width in the range of 14 to 26 mm, as disclosing an
embodiment of a lumbar spinal fusion implant having a width of 18 mm. Id.
at 27,52 . According to Petitioner, the ordinary artisan would have modified
the implant of SVS or Telamon to have a maximum width of approximately
18 mm, as Michelson teaches that a greater surface area of contact of the
implant with the adjacent vertebra allows for greater stability. Id. at 27–28,
52 (citing Ex. 1105, 7:11–20).
Patent Owner contends that the SVS and Telamon “disclose PLIF
implants designed with the intended purpose of use in PLIF procedures.”
PO resp. 47 (citing Ex. 2020, ¶¶ 79, 80, 84, 85). Although Petitioner relies
on Michelson to meet the limitation of the implant being lengthened to
exceed 40 mm in length, Patent Owner asserts that “Michelson discloses
length in excess of 40 mm only for laterally inserted implants.” Id.
Petitioner asserts that modifying the implant of either SVS or Telamon to be
greater than 40 mm would eliminate SVS and Telamon’s “specifically
intended insertion path and usage,” making the SVS and Telamon implants
inoperable for their intended use in PLIF procedures. Id. at 51 (citing Ex.
2020 ¶¶ 105, 106). That is, Patent Owner argues, the increased length would
IPR2013-00506
Patent 8,361,156 B2

16
make the implant of SVS and Telamon unsafe for a posterior insertion path.
Id. at 51–55. Patent Owner asserts that Petitioner’s approach that “require[s]
a wholesale abandonment of the primary reference’s intended PLIF purpose
so as to achieve an entirely different use and operation.” Id. at 53. Patent
Owner contends that “[t]he fact that Dr. Hynes proposes modifying the SVS-
PR and Telamon implants in a way that would cause them to be unsafe in
PLIF procedures is evidence that Dr. Hynes is simply reading the claim
language and then improperly inventing combinations using the benefit of
hindsight.” Id. at 56.
Petitioner responds that the claims are drawn to an apparatus, that is, a
spinal implant, and are not method claims. Reply 1. Moreover, Petitioner
notes that the Specification of the ’156 patent states that the implants may be
introduced through a variety of approaches. Id. (citing Ex. 1115, 5:31–34).
Petitioner asserts further that Patent Owner’s expert, Dr. Yuan, testifies that
he had inserted implants suitable for a PLIF or ALIF approach using a lateral
or oblique approach. Id. (citing Ex. 2020 ¶ 51).
Petitioner responds further that both Dr. Hynes and Dr. Yuan
acknowledge that “a longer implant increases stability and provides more
structural support to the adjacent vertebrae.” Reply 4 (citing Ex. 1157 ¶¶ 7,
24; Ex. 2020 ¶ 41). Moreover, Petitioner argues, longer implants have been
inserted using a posterior approach, and Dr. Yuan in fact “admitted that the
disc space can accommodate such implants, much like the ones he himself
inserted.” Id. at 5 (citing Ex. 1173, 62, 121–122, 245). Dr. Yuan also
testified that the Telamon implant, “as a vertebral body spacer, could be put
in laterally, at an angle, or anteriorly,” and that the SVS implant “could be
inserted laterally, at an angle, or anteriorally.” Id. at 7 (citing Ex. 1173, 62,
IPR2013-00506
Patent 8,361,156 B2

17
121–122). Dr. Yuan testified also that “an implant over 40 mm could be
inserted posterior laterally (at an angle) from the back and fit in the disc
space.” Id. at 10 (citing Ex. 1173, 233–234). According to Petitioner, Dr.
Hynes agrees, and has done such surgeries. Id. (citing Ex. 1157 ¶ 5).
After considering the parties respective positions and evidence, we do
not find Patent Owner’s contentions persuasive SVS discloses that “[t]he
Vertebral Spacer is a vertebral body replacement device intended for use in
the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or
unstable vertebral body due to tumor or trauma (i.e., fracture).” Ex. 1106, 1.
Hence, the “intended purpose” of the implant of SVS is to replace
components within vertebrae. Telamon discloses a process of inserting an
implant into an intervertebral space to achieve “decompression of the neural
elements” and “satisfactory immobilization of the grafted interspace.” Ex.
1108, 9. Hence, the “intended purpose” of the implant of Telamon is to
achieve immobilization of the grafted interspace (and/or decompression of
neural elements). We disagree with Patent Owner that Michelson, which
discloses an implant that “engage[s] more of the adjacent vertebrae,” and,
thus, “permits greater stability” (Ex. 1105, 3:49–51) would have “fully
eliminated” the purpose of the SVS or Telamon implants of replacing
collapsed, damaged, or unstable intervertebral components or immobilizing
the interspace. Instead, the intended purpose of Michelson (a spinal fusion
implant) appears to be the same as the intended purpose of either of SVS or
Telamon, i.e., to achieve immobilization of the grafted interspace.
As to the argument that inserting a longer implant, such as an implant
that is approximately 40 mm in length, posteriorly, would have been
dangerous, Petitioner submits evidence supporting the contention that the
IPR2013-00506
Patent 8,361,156 B2

18
insertion of implants measuring over 40 mm in length via a posterior
approach is practiced safely in the art and, therefore, we are not persuaded
by Patent Owner (PO Resp. 53–54) that “no responsible surgeon” would
insert an implant measuring greater than 40 mm in length posteriorly. For
example, Petitioner explains that Tohmeh (US Patent No. 8,623,088 B1 (Ex.
1131)) discloses a spinal implant measuring up to 45 mm in length uses a
“posterior approach.” Reply 5 (citing Ex. 1131, 4:3, 5:32–35). Tohmeh
does not disclose that such a practice would be “extremely dangerous to the
patient, risking paralysis or death” (PO resp. 53). In addition, as Petitioner
explains, Dr. Yuan testified that a spinal implant measuring greater than 40
mm in length would fit within the circumference of the intervertebral space.
Reply 5 (citing Ex. 1173, 244–245).
Moreover, even assuming to be true Patent Owner’s contention that a
responsible surgeon would not insert a 41 mm implant in the PLIF approach,
we are not persuaded by Patent Owner’s argument because one of ordinary
skill in the art, based on Michelson, would have inserted the “41 mm
implant” laterally, not posteriorly. Patent Owner presents no evidence that
maneuvering the implant to prevent damage to the annulus on the anterior
aspect of the disc would have been uniquely challenging or difficult for one
of ordinary skill in the art. See Leapfrog Enters., Inc. v. Fisher-Price, Inc.,
485 F.3d 1157, 1162 (Fed. Cir. 2007) (citing KSR Int’l Co. v. Teleflex, Inc.,
550 U.S. 398, 418 (2007)). Indeed, Michelson discloses an implant with a
length that is greater than 40 mm and does not disclose that inserting such an
implant results in damage to the annulus on the anterior aspect of the disc.
Ex. 1105, 10:41–46. Hence, Michelson demonstrates that it would have
been obvious to one of ordinary skill in the art to have inserted an implant
IPR2013-00506
Patent 8,361,156 B2

19
measuring at least 40 mm in length without damage to the annulus on the
anterior aspect of the disc.
As to claim 9, Patent Owner contends again that the intended purpose
of the SVS and Telamon implants is PLIF implantation, whereas Michelson
teaches a width of 18mm only for laterally inserted implants. PO Resp. 57.
According to Patent Owner. “[w]idening the SVS-PR and Telamon PLIF
implants to be 18 mm would render them inoperable for their intended
purpose of PLIF implantation.” Id. at 58 (citing Ex. 2020 ¶¶ 109-113).
Patent Owner argues that modifying the SVS or Telamon implant would
make the implant too wide to be safely inserted posteriorly in a PLIF
procedure. Id.
Petitioner responds that “it is undisputed that one of ordinary skill in
the art would have been motivated to adjust the dimensional footprints of
SVS-PR and Telamon, including their respective widths, to provide a more
stable implant that better supports its adjacent vertebrae.” Reply 6. We
conclude that Petitioner has the better position for the same reasons set forth
with respect to claim 5. That is, the claim is drawn to an apparatus, and not
a method of insertion. It would have well within the level of skill of the
ordinary surgeon to determine the appropriate size of the implant. See, e.g.,
Ex. 1115, 11:10–12 (noting that before a spinal fusion procedure is
performed, “the clinician must first designate the appropriate implant size.”).
Moreover, Michelson specifically teaches an implant having a width of
18mm, and one of ordinary skill in the art, based on Michelson, would have
understand that the “18 mm implant” could be laterally, rather than
posteriorly.
IPR2013-00506
Patent 8,361,156 B2

20
4. Claims 2–4, 6–8, 10–14, 19, 20, and 23–27
Patent Owner presents no additional argument as to dependent claims
2–4, 6–8, 10–14, 19, 20, and 23–27. PO Resp. 46. Upon review of those
claims, as well as the contentions and evidence relied upon by Petitioner, we
determine that the preponderance of the evidence of record demonstrates
that those claims are rendered also unpatentable over the challenges as based
on SVS or Telamon.
5. Secondary Considerations
Before we can determine that the obviousness determinations above
render the challenged claims unpatentable, we must consider the evidence of
obviousness anew in light of any evidence of secondary considerations of
nonobviousness presented by Patent Owner. See Graham, 383 U.S. at 17–
18 (“Such 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. As indicia of obviousness or nonobviousness, these inquiries may
have relevancy.”); Transocean Offshore Deepwater Drilling, Inc. v. Maersk
Drilling USA, Inc., 699 F.3d 1340, 1349 (Fed. Cir. 2012) (“This objective
evidence must be ‘considered as part of all the evidence, not just when the
decision maker remains in doubt after reviewing the art.’”) (quoting
Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538–39 (Fed. Cir.
1983)).
“Evidence of commercial success, or other secondary considerations,
is only significant if there is a nexus between the claimed invention and the
commercial success.” Ormco Corp. v. Align Tech. Inc., 463 F.3d 1299,
1311–12 (Fed. Cir. 2006). “For objective evidence to be accorded
IPR2013-00506
Patent 8,361,156 B2

21
substantial weight, its proponent must establish a nexus between the
evidence and the merits of the claimed invention.” In re GPAC Inc., 57 F.3d
1573, 1580 (Fed. Cir. 1995). In order to establish a proper nexus, the patent
owner 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.
See Microsoft v. Proxyconn, Inc., Case IPR2012-00026, slip op. at 4 (PTAB
Mar. 8, 2013) (Paper 32).
Patent Owner contends that the evidence of commercial success
demonstrates the non-obviousness of the claimed implants. PO Resp. 59.
According to Patent Owner, “the detailed testimony establishes a nexus
between NuVasive’s CoRoent XL implants and the invention of the ‘156
patent, and proves the commercial success of the product after NuVasive
pioneered the market for lateral, trans-psoas interbody fusion surgeries with
the CoRoent XL implant.” Id. (citing Ex. 2020 ¶¶53-63; Ex. 2030 ¶¶ 7-10
and App. A). Patent Owner asserts further that the fact that Petitioner never
practiced the lateral lumbar implants depicted in Michelson ’973, and did
not introduce its Clydesdale implants until the success of Patent Owner’s
CoRoent XL, “is telling of [Patent Owner’s] commercial success and
pioneering efforts.” Id. (citing Ex. 2030 ¶¶ 7, 9 and App. A at 8).
First, we note that Patent Owner did not even attempt to establish any
nexus between the claimed implant and any purported commercial success
in its response, but merely cited to the Declaration of Patrick Miles (Ex.
2030) and the Declaration of Dr. Yuan (Ex. 2020), which improperly
incorporates such arguments by reference from those Declarations into the
Patent Owner response. See 37 C.F.R. § 42.6(a)(3) (“Arguments must not
IPR2013-00506
Patent 8,361,156 B2

22
be incorporated by reference from one document into another document.”);
see also Rules of Practice for Trials Before The Patent Trial and Appeal
Board and Judicial Review of Patent Trial and Appeal Board Decisions;
Final Rule, 77 Fed. Reg. 48,612, 48,617 (Aug. 14, 2012) (prohibition against
incorporation by reference is to eliminate abuses that arise from
incorporation).
Moreover, Dr. Yuan merely opines that it is his opinion that the
CoRoent XL implant embodies the claims of the ’156 patent. Ex. 2020 ¶ 53.
And although Mr. Miles states that “NuVasive’s CoRoent XL implants have
enjoyed commercial success” (Ex. 2030 ¶ 9), neither the Declaration, nor
Appendix A, explains why that success is due to the characteristics of the
claimed invention, rather than to XLIF5 system as a whole, or to marketing
of the implant (See, e.g., Ex. 2030, Appendix A (DLIF marketing plan)).
And even assuming that NuVasive’s CoRoent XL implant experienced
“commercial success,” as Patent Owner asserts, Patent Owner has not
demonstrated sufficiently that there is a nexus between the merits of the
claimed invention and the evidence offered. For example, Patent Owner
argues that NuVasive “pioneered the market for lateral, trans-psoas
interbody fusion surgeries,” (PO Resp. 59) but fails to demonstrate
sufficiently that any of the disputed claims recite “lateral, trans-psoas
interbody fusion surgeries.” Thus, Patent Owner’s evidence of secondary
considerations is entitled to little weight.

5 According to Mr. Miles, the XLIF (eXtreme Lateral Interbody Fusion)
system and procedure include the CoRoent XL implant. Ex. 2030 ¶ 3.
IPR2013-00506
Patent 8,361,156 B2

23
6. Conclusion
After considering Petitioner’s and Patent Owner’s positions, as well as
their supporting evidence, we determine that Petitioner has shown by a
preponderance of the evidence that claims 1–4, 7, 8, 10–14, 19, 20, 23, 24,
26, and 27 are rendered obvious under 35 U.S.C. § 103(a) by the
combination of SVS and Baccelli; claims 5, 6, and 9 are rendered obvious
under 35 U.S.C. § 103(a) by the combination of SVS, Baccelli, and
Michelson; claim 25 is rendered obvious under 35 U.S.C. § 103(a) by the
combination of SVS, Baccelli, and Telamon; claims 1–4, 7, 10–14, 19, 20,
and 23–27 are rendered obvious under 35 U.S.C. § 103(a) by the
combination of Telamon and Baccelli; and claims 5, 6, 8, and 9 are rendered
obvious under 35 U.S.C. § 103(a) by the combination of Telamon, Baccelli,
and Michelson.

C. Patent Owner’s Motion to Exclude (Paper 34)
In its Motion to Exclude, Patent Owner seeks to exclude the
Declaration of Loic Josse (Ex. 1116, “Josse Declaration”). We did not rely
on the Josse Declaration in this decision. Therefore, Patent Owner’s motion
to exclude is dismissed as moot.

D. Motion for Observation
Patent Owner’s observations are directed to the cross-examination
testimony of Richard A. Hynes, M.D. (Ex. 2037), who was cross-examined
after Petitioner filed its Reply. Paper 38. We have considered Patent
Owner’s observations and Petitioner’s responses in rendering our decision,
and have accorded the testimony the appropriate weight.
IPR2013-00506
Patent 8,361,156 B2

24
Patent Owner also submits observations to the cross-examination
testimony of Loic Josse. Paper 39. As previously discussed, we did not rely
on the Josse Declaration in this decision. Therefore, we have not considered
Patent Owner’s observations directed to the cross-examination testimony of
Loic Josse.

III. CONCLUSION
Petitioner has shown by a preponderance of the evidence that claims
1–14, 19, 20, and 23–27 are unpatentable under 35 U.S.C. § 103(a).

IV. ORDER
Accordingly, it is hereby:
ORDERED that Petitioner has shown by a preponderance of the
evidence that claims 1–14, 19, 20, and 23–27 of the ’156 patent are
unpatentable;
FURTHER ORDERED that Petitioner’s Motion to Exclude is
dismissed as moot; and
FURTHER ORDERED that, because this is a final written decision,
parties to the proceeding seeking judicial review of the decision must
comply with the notice and service requirements of 37 C.F.R. § 90.2.

IPR2013-00506
Patent 8,361,156 B2

25
PETITIONER:

Jeff E. Schwartz
Seth A. Kramer
FOX ROTHSCHILD LLP
jeschwartz@foxrothschild.com
skramer@foxrothschild.com

PATENT OWNER:

Stephen R. Schaefer
Michael T. Hawkins
Stuart Nelson
FISH AND RICHARDSON PC
schaefer@fr.com
hawkins@fr.com
IPR13958-0117IP1@fr.com