Medtronic, Inc.v.Nuvasive, Inc.

Patent Trial and Appeal Board

Feb 13, 2014

13441092 (P.T.A.B. Feb. 13, 2014)

Trials@uspto.gov Paper 8
571-272-7822 Entered: February 13, 2014

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

MEDTRONIC, INC.
Petitioner

v.

NUVASIVE, INC.
Patent Owner
____________

Case IPR2013-00504
Patent 8,361,156
____________

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

GREEN, Administrative Patent Judge.

DECISION
Denying Institution of Inter Partes Review
37 C.F.R. § 42.108

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I. BACKGROUND
Medtronic, Inc. (“Medtronic”) filed a Petition (“Pet.”) requesting an inter
partes review of claims 1–14, 19, 20, and 23–27 of U.S. Patent No. 8,361,156 (Ex.
1013, “the ’156 patent”) on August 14, 2013. Paper 3. Patent Owner, NuVasive,
Inc. (“NuVasive”), filed a preliminary response on November 25, 2013. Paper 7.
We have jurisdiction under 35 U.S.C. §§ 6(b) and 314.
The standard for instituting an inter partes review is set forth in 35 U.S.C.
§ 314(a), which states:
THRESHOLD. – The Director may not authorize an inter partes review
to be instituted unless the Director determines that the information
presented in the petition filed under section 311 and any response
filed under section 313 shows that there is a reasonable likelihood that
the petitioner would prevail with respect to at least 1 of the claims
challenged in the petition.

Inter partes review is instituted only if the petition supporting the ground
demonstrates “that there is a reasonable likelihood that at least one of the claims
challenged in the petition is unpatentable.” 37 C.F.R. § 42.108(c).
Upon consideration of the Petition, we conclude that Medtronic has not
established a reasonable likelihood that it would prevail with respect to any of the
challenged claims of the ’156 patent. Accordingly, we deny the Petition, and
decline to institute inter partes review.

A. Related Proceedings
Medtronic indicates that it has filed concurrently another petition for an inter
partes review of the ’156 patent. Pet. 2. Medtronic indicates further that it is a
named counterclaim-defendant in the litigation titled Warsaw Orthopedic, Inc. v.
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NuVasive Inc., Case No: 3:12-cv-02738-CAB-MDD (S.D. Cal.), which also
involves the ’156 patent. Pet. at 1.

B. The ’156 Patent (Ex. 1013)
The ’156 patent is drawn to a spinal implant, and methods of spinal fusion
using the implant. ’156 patent, col. 1, ll. 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 col. 1, ll. 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. Id. at col. 5, ll. 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 col. 5, ll. 10-15.

C. Representative Claim
Medtronic challenges claims 1–14, 19, 20, and 23–27 of the ’156 patent.
Claim 1 is the only independent claim, and reads as follows (emphasis added):
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;

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

D. Prior Art Relied Upon
Medtronic relies upon the following prior art references:
Michelson (“Michelson”), US 5,860,973, issued January 19, 1999
(Ex. 1005).

Frey et al. (“Frey”), US Patent Appl. Pub. No. 2002/0165550 A1,
published November 7, 2002 (Ex. 1003).

Baccelli et al. (“Baccelli”), US Patent Appl. Pub. No. 2003/0028249
A1, published February 6, 2003 (Ex. 1004).

Messerli et al. (“Messerli”), US Patent Appl. Pub. No. 2003/0139813
A1, published July 24, 2003 (Ex. 1007).

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Moret, US Patent Appl. Pub. No. 2003/0100950 A1, published May
29, 2003(Ex. 1006).

E. The Asserted Grounds of Unpatentability
Medtronic challenges the patentability of claims of the ’156 patent on the
following grounds. Pet. 3.

Reference(s) Basis Claims challenged
Frey and Baccelli § 103 1–8, 10–14, 19, 20,
and 23–27
Frey, Baccelli, and
Messerli
§ 103 1–8, 10–14, 19, 20,
and 23–27
Frey, Baccelli, and
Michelson
§ 103 1–14, 19, 20, and
23–27
Frey, Baccelli, and Moret § 103 1–8, 10–14, 19, 20,
and 23–27
Baccelli and Frey § 103 1–8, 10–14, 19, 20,
and 23–27

II. ANALYSIS
A. Claim Construction
In an inter partes review, claim terms in an unexpired patent are given their
broadest reasonable construction in light of the specification of the patent in which
they appear. 37 C.F.R. § 42.100(b). Under the broadest reasonable construction
standard, claim terms are given their ordinary and customary meaning in view of
the specification as would be understood by one of ordinary skill in the art at the
time of the invention. In re Translogic Tech., Inc., 504 F.3d 1249, 1257 (Fed. Cir.
2007). Any special definition for a claim term must be set forth in the
specification with reasonable clarity, deliberateness, and precision. In re Paulsen,
30 F.3d 1475, 1480 (Fed. Cir. 1994). For purposes of this Decision, we interpret
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the claim language consistently with its plain and ordinary meaning, when read in
view of the Specification.

B. Obviousness Challenges.
Claim 1 requires (emphasis added):
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.
All of the challenges asserted by Medtronic in this proceeding rely on Frey
(Ex. 1003) to teach the above limitation. Frey is drawn to implants that may be
inserted into the spinal disc space, as well as techniques for insertion of the implant
using a posterior lateral approach. Ex. 1003, ¶¶ [0002] and [0006].
According to Medtronic:
Frey provides that the implant has a longitudinal length that extends
from the proximal wall to the distal wall and a maximum lateral width
extending from the first side wall to the second sidewall. As shown in
Figure 63 of Frey, the longitudinal length is perpendicular to, and
greater than, the maximum lateral width.

Pet. 18; see id. at 37, 38, 43, and 48.

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Medtronic (Pet. 18) provides the following annotated reproduction of Figure
63 of Frey:

Figure 63 of Frey shows an elevational view of an implant of Frey.
Ex. 1003 ¶¶ 0071, 0075.

As asserted by NuVasive, however, Medtronic does not address the
limitation that the “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,” as required by claim 1. Prelim. Resp. 9-
10. That is, while Medtronic identifies the longitudinal length, as well as the
maximum lateral width, Medtronic does not specify how the maximum lateral
width extends between the two sidewalls along the medial plane of the implant.

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Moreover, Medtronic provides the following annotated reproduction of
Figure 59 of Frey (Pet. 20):

Figure 59 is a perspective view of an implant taught by Frey.
Ex. 1003 ¶ 0071.

As can be seen from annotated Figure 59, Medtronic recognizes that the
medial plane of the implant would be a plane that intersects the implant
approximately at the midpoint of the longitudinal length. The maximal lateral
width, as shown in annotated Figure 63, is not at the midpoint of the longitudinal
length, but is closer to one end of the implant than the other. Stated differently,
Medtronic does not explain how the maximum lateral width of the implant is along
a medial plane that is generally perpendicular to the longitudinal length, as
required by independent claim 1.
Thus, Medtronic has not demonstrated a reasonable likelihood that it will
prevail on any of its challenges.

III. CONCLUSION
For the foregoing reasons, we determine that Medtronic has not
demonstrated a reasonable likelihood that it will prevail on its challenges of claims
1–14, 19, 20, and 23–27 of the ’156 patent. We, therefore, do not institute an inter
partes review on any of the asserted grounds as to any of the challenged claims.

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IV. ORDER
In consideration of the foregoing, it is hereby:
ORDERED that the Petition is denied as to all challenged claims of the ’156
patent.

PETITIONER:

Jeff E. Schwartz
Seth A. Kramer
Fox Rothschild LLP
jeschwartz@foxrothschild.com
skramer@foxrothschild.com

PATENT OWNER:

Stephen R. Schaefer
Michael T. Hawkins
Fish & Richardson P.C.
Schaefer@fr.com
Hawkins@fr.com
IPR13958-0117IP1@fr.com