Globus Medical, Inc.v.Flexuspine, Inc.

Patent Trial and Appeal Board

Feb 24, 2016

10660155 (P.T.A.B. Feb. 24, 2016)

Trials@uspto.gov Paper 11
Tel: 571-272-7822 Entered: February 24, 2016

UNITED STATES PATENT AND TRADEMARK OFFICE
_______________
BEFORE THE PATENT TRIAL AND APPEAL BOARD
_______________
GLOBUS MEDICAL, INC.,
Petitioner,

v.

FLEXUSPINE, INC.,
Patent Owner.
_______________

Case IPR2015-01721
Patent 7,316,714 B2
_______________

Before WILLIAM V. SAINDON, HYUN J. JUNG, and
TIMOTHY J. GOODSON, Administrative Patent Judges.

SAINDON, Administrative Patent Judge.

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

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Patent 7,316,714 B2

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I. INTRODUCTION
Petitioner requests an inter partes review of claims 1 and 2 of U.S.
Patent No. 7,316,714 B2 (Ex. 1001, “the ’714 patent”). Paper 2 (“Pet.”).
Patent Owner filed a Preliminary Response to the Petition. Paper 9
(“Prelim. Resp.”).
We have jurisdiction under 35 U.S.C. § 314, which provides that
an inter partes review may not be instituted “unless . . . there is a reasonable
likelihood that the petitioner would prevail with respect to at least 1 of the
claims challenged in the petition.” Upon consideration of the Petition, the
exhibits cited therein, and Patent Owner’s Preliminary Response, we do not
institute an inter partes review on any challenged claims.
A. Related Matters
Petitioner represents that it has been accused of infringement of the
’714 patent in Flexuspine, Inc. v. Globus Medical, Inc., Case 15-cv-00201-
JRG-KNM (E.D. Tex.). Pet. 3. Petitioner also represents that it has
simultaneously requested inter partes reviews of several other patents owned
by Patent Owner. Id. at 3–4.
B. The ’714 Patent
The ’714 patent is directed to an expandable artificial intervertebral
implant. Ex. 1001, Abstr. The particular embodiment recited in claims 1
and 2 is depicted in Figures 17a–c. Patent Owner included annotated
versions of Figures 17b and 17c of Exhibit 1001, which are reproduced
below:
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Prelim. Resp. 4.
Figures 17b and 17c depict an expandable artificial intervertebral
implant. Both figures depict an upper body and a lower body, with insert
810 in between. As shown in Figure 17b, set screw 830 can be advanced
such as to press expansion plate 820 against insert 810. After advancing set
screw 830 sufficiently, and as shown in Figure 17c, expansion plate 820 acts
upon insert 810 to cause the insert to separate the upper and lower bodies.
See also Ex. 1001, 12:61–13:14 (describing Figures 17b and 17c).
C. Illustrative Claim
Independent claim 1 is the sole independent claim challenged by
Petitioner and is reproduced below.
1. An intervertebral implant for a human spine,
comprising:
an upper body comprising an inferior surface and a
superior surface, wherein the superior surface of the
upper body is configured to engage a first vertebra
of the human spine;
a lower body comprising a superior surface and an
inferior surface, wherein the inferior surface of the
lower body is configured to engage a second
vertebra of the human spine;
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an insert comprising a superior surface and an inferior
surface, wherein the insert is configured to be
positioned between the superior surface of the lower
body and the inferior surface of the upper body
before insertion of the intervertebral implant
between the first vertebra and the second vertebra
of the human spine;
an expansion member configured to engage the insert;
a set screw configured to be rotated to advance the
expansion member to engage the insert such that the
insert increases a separation distance between the
upper body and the lower body after insertion of the
intervertebral implant in the human spine; and
wherein the intervertebral implant is configured such
that increasing the separation distance between the
upper body and the lower body allows articulation
or increased articulation of the intervertebral
implant.

D. Prior Art and Asserted Grounds
Petitioner asserts that claims 1 and 2 of the ’714 patent are
unpatentable under 35 U.S.C. § 103 as obvious in view of Larsen (US Patent
No. 5,782,832, issued July 21, 1998) (Ex. 1004), and the knowledge of one
of ordinary skill in the art. Petitioner also relies on the testimony of Jorge A.
Ochoa, Ph.D., P.E. (Ex. 1005).
II. ANALYSIS
A. Claim Construction
We interpret the claims of an unexpired patent using the broadest
reasonable interpretation in light of the specification of the patent. 37 C.F.R.
§ 42.100(b); In re Cuozzo Speed Techs., LLC, 793 F.3d 1268, 1278 (Fed.
Cir. 2015), cert. granted sub nom. Cuozzo Speed Techs., LLC v. Lee, 84
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U.S.L.W. 3218 (U.S. Jan. 15, 2016) (No. 15-446). Under the broadest
reasonable interpretation standard, claim terms are given their ordinary and
customary meaning, as would be understood by one of ordinary skill in the
art in the context of the entire disclosure. In re Translogic Tech. Inc., 504
F.3d 1249, 1257 (Fed. Cir. 2007). Any special definition for a claim term
must be set forth with reasonable clarity, deliberateness, and precision. In re
Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994).
Petitioner does not offer a construction for any claim terms. Pet. 8–9.
Patent Owner offers a construction of the term “insert,” found in both
challenged claims. Prelim. Resp. 8–9. For example, claim 1 recites “an
insert comprising a superior surface and an inferior surface, wherein the
insert is configured to be positioned between the . . . lower body and the . . .
upper body.” Patent Owner proposes that the ordinary and customary
meaning of “insert,” in the context of claim 1, is “a member separate from
and disposed between the upper and lower bodies.” Id. at 9. Patent Owner
states that “[q]uite simply, something referred to as an insert must have been
or is intended to be inserted into something; otherwise it would not be
referred to as an insert.” Id.
Reading claim 1 in context, we agree with Patent Owner that the
claimed insert must be a separate structure from the upper and lower bodies,
in order to give due consideration to the term “insert” itself as well as to the
relationship defined in the claims between the upper body, lower body, and
the insert. To this end, we disagree with Petitioner’s characterization of the
“insert” limitation as “a recitation of the intended use for the claimed
apparatus” and “not material to patentability.” Pet. 22. On that matter,
Petitioner argues that “configured to be positioned” does not “disclose any
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intrinsic or structural limitation of the implant.” Id. at 23. This argument is
unpersuasive. The “insert . . . configured to be positioned between the . . .
lower body and the . . . upper body” language sets forth structural features
insofar as it requires (1) an insert having various surfaces and (2) the insert
to be of a size and shape that allows it to be located between the upper and
lower bodies in the manner claimed. Patent Owner also provides persuasive
extrinsic evidence that an “insert” would be understood by a person of
ordinary skill in the art as a structure capable of insertion (i.e., separate from
that into which it is inserted). Prelim. Resp. 8–9 (citing Ex. 2003, dictionary
definition of “insert”).1 The ’714 patent’s specification supports this
understanding by consistently showing the insert to be a separate and
discrete element from the upper and lower bodies. Ex. 1001, 8:46–59, 9:22–
29, 9:50–55. Further, claim 1 specifies the place into which the insert is to
be inserted: between the upper and lower bodies. Thus, the insert must be
of a size and shape to accommodate insertion into such a location.
Accordingly, on this record, we are persuaded that the broadest
reasonable interpretation of “insert” is “a member separate from and
disposed between the upper and lower bodies.”

1 Although not controlling, we note that this term has been construed
similarly in another proceeding. See Miken Composites, L.L.C. v. Wilson
Sporting Goods Co., 515 F.3d 1331, 1336–38 (Fed. Cir. 2008) (affirming
construction of “insert” to mean “something inserted or intended for
insertion” because the patent at issue “consistently use the term ‘insert’ in
the sense of the ordinary meaning as ‘something inserted or intended for
insertion.’”) (citations omitted).
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B. Petitioner’s Ground
Claim 1 requires an implant having “an insert comprising a superior
surface and an inferior surface, wherein the insert is configured to be
positioned between the . . . lower body and the . . . upper body.” Petitioner
identifies the claimed insert as “integral to the inferior surface” of the upper
body in Larsen. Pet. 23. Figure 23 of Larsen is reproduced below with
Petitioner’s identification of an insert highlighted in green:
Figure 23 of Larsen depicts a spinal implant having upper support member
402 and lower support member 404 connected via a pin-and-slot
arrangement (432, 424), with camming block 412 serving to push apart
lower support member 404 and inner surface 416 of support member 402
when screw 418 is advanced. Ex. 1004, 8:8–28.
Petitioner identifies inner surface 416 of support member 402 as the
claimed insert. Pet. 23. Patent Owner argues that inner surface 416 is not an
insert because it is integral with the upper support member. Prelim. Resp.
12–13. Patent Owner’s argument is persuasive because we have construed
“insert,” in the context of claim 1, as a structure separate from the upper and
lower bodies.
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Petitioner proposes an alternative ground, in which the wedge-shape
of inner surface 416 is separated from upper support member 402 of Larsen.
Pet. 23–26. Petitioner asserts that such a modification is “known” and
would add “modularity” and the “benefit of allowing the surgeon to select
inserts and camming blocks of varying sizes and/or angles.” Id. at 24.
Petitioner offers evidence allegedly showing that such modularity was well
known. Id. (citing Exs. 1005, 1009, 1013, 1015).
Exhibits 1009, 1013, and 1015 each describe similar artificial discs.
As best shown in Figure 1 of Ex. 1009, reproduced below, these discs
comprise upper part 2, lower part 3, and pivot insert 4:
Figure 1 of Ex. 1009 depicts an artificial disc.
Exhibits 1013 and 1015 discuss similar discs, and also disclose that
these three parts come in various sizes. Ex. 1013, S128; Ex. 1015, 363.
Petitioner’s declarant, Dr. Ochoa, reviews these Exhibits and concludes that
making inner surface 416 of support member 401 of Larsen a separate
component is a design choice. Ex. 1005 ¶ 36.
Patent Owner argues that Petitioner’s alternative ground is made
without support. Prelim. Resp. 14–15. Specifically, Patent Owner points
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out that Petitioner has not shown why the proposed additional modularity
would be necessary or desirable because Larsen already allows for the
change of elevation and angle of the implant using the existing wedge-and-
screw design. Id. at 15. In other words, according to Patent Owner, the
proposed modification adds no features to those already existing in Larsen.
Reviewing the record before us, we determine that Petitioner has not
shown a reasonable likelihood of prevailing on this ground. In particular,
claim 1 requires both an insert and a set screw used to engage the insert.
Petitioner proposes to break up the upper portion of Larsen to create an
insert, but Petitioner’s reasons for doing so are unpersuasive. Although
Petitioner shows that it was known to provide various sizes of implant
components, the examples shown do not use an insert and set screws.
Instead, the examples appear to allow users the ability to pick and choose
various insert sizes, without the adjustment-type sizing implicated by the
claimed insert and set screw arrangement; thus, they are different kinds of
inserts. Accordingly, the “modularity” shown in those examples does not
help explain why it would have been obvious to break up the upper portion
of Larsen to create a separate insert. Petitioner has not offered any cogent
reason for breaking up the upper portion of Larsen, nor has Petitioner
offered evidence tending to show that this particular arrangement was
known. Consequently, Petitioner has not offered sufficient reasoning
explaining why the subject matter of claim 1 would have been obvious in
view of Larsen and the knowledge of a person of ordinary skill in the art.
C. Conclusion
In view of the above, we are persuaded that, on the record before us,
Petitioner has not demonstrated a reasonable likelihood of showing claim 1
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to be unpatentable. Petitioner’s analysis for claim 2, which depends from
claim 1, does not cure the underlying deficiency in the proposed ground for
claim 1. See Pet. 41–44.
III. ORDER
In view of the foregoing, it is hereby ORDERED that the Petition is
denied and no inter partes review is instituted.

PETITIONER:

George D. Moustakas
David P. Utykanski
HARNESS, DICKEY & PIERCE, P.L.C.
gdmoustakas@hdp.com
dutykanski@hdp.com

PATENT OWNER:

Brett M. Pinkus
Jonathan T. Suder
(pro hac vice motion pending)
FRIEDMAN, SUDER & COOKE
pinkus@fsclaw.com
jts@fsclaw.com

Mark D. Strachan
(pro hac vice motion pending)
SAYLES│WERBNER, P.C.
mstrachan@swtriallaw.com