Warsaw Orthopedic, Inc. v. Globus Medical, Inc.

NOTE: This disposition is nonprecedential.

United States Court of Appeals
for the Federal Circuit
__________________________

WARSAW ORTHOPEDIC, INC., MEDTRONIC
SOFAMOR
DANEK USA, INC., MEDTRONIC PUERTO RICO
OPERATIONS COMPANY AND MEDTRONIC
SOFAMOR
DANEK DEFFENDORF, GMBH,
Plaintiffs-Appellees,

v.
GLOBUS MEDICAL, INC.,
Defendant-Appellant.
__________________________

2009-1525
__________________________

Appeal from the United States District Court for the
Eastern District of Pennsylvania in case No. 06-CV-4248,
Judge Norma L. Shapiro.
___________________________

Decided: January 26, 2011
___________________________

SETH P. WAXMAN, Wilmer Cutler Pickering Hale and
Dorr, LLP, of Washington, DC, argued for plaintiffs-
appellees. With him on the brief were WILLIAM G.
WARSAW ORTHOPEDIC v. GLOBUS MEDICAL 2

MCELWAIN, GREGORY H. LANTIER, and AMY J. NELSON;
and CYNTHIA D. VREELAND and MARK C. FLEMING, of
Boston, Massachusetts.

CONSTANTINE L. TRELA, JR., Sidley Austin, LLP, of
Chicago, Illinois, argued for defendant-appellant. With
her on the brief was RACHEL H. TOWNSEND, Sidley Austin,
LLP, of Washington, DC.

__________________________

Before LOURIE, BRYSON, and PROST, Circuit Judges.
PER CURIAM.

Globus Medical, Inc., appeals from a final judgment of
the United States District Court for the Eastern District
of Pennsylvania relating to a patent infringement suit
brought by Warsaw Orthopedic, Inc. Warsaw asserted
three claims of U.S. Patent No. 6,530,929 (“the ’929
patent”) and two claims of U.S. Patent No. 7,008,422 (“the
’422 patent”). The jury found each of the five asserted
claims valid and infringed. Following trial, Globus moved
for judgment as a matter of law (“JMOL”) that the as-
serted claims are invalid as anticipated and are not
infringed. The district court denied Globus’s motions
without opinion.

On appeal, Globus challenges the judgment of in-
fringement based on the district court’s claim construc-
tion. In the alternative, Globus challenges the court’s
denial of its motion for JMOL of invalidity based on
anticipation. Because we agree with Warsaw that the
asserted claims are not limited to the preferred embodi-
ment described in the specification, we affirm the court’s
construction of the terms at issue on appeal. As to antici-
pation, we reverse the denial of Globus’s motion for JMOL
3 WARSAW ORTHOPEDIC v. GLOBUS MEDICAL

with respect to claim 45 of the ’929 patent and claim 42 of
the ’422 patent. We affirm the court’s denial of the JMOL
motion with respect to claims 47 and 74 of the ’929 patent
and claim 48 of the ’422 patent. We remand this case to
the district court to consider whether the damages award
should be revisited in light of this decision.

I

The two patents in suit are both entitled “Instruments
for Stabilization of Bony Structures,” and they share a
common specification. The stabilization procedure dis-
cussed in the specification involves inserting a bone screw
into each of two adjacent vertebrae and connecting the
two screws with a rod or connecting element, sometimes
referred to as a “brace.” The illustrated and described
embodiment corresponds to the Sextant, Warsaw’s com-
mercial embodiment, which is depicted in Figure 1 of each
of the asserted patents.
WARSAW ORTHOPEDIC v. GLOBUS MEDICAL 4

As illustrated by Figure 1, the specification describes
a mechanical instrument for use in spine stabilization
surgery. To use the device discussed in the specification,
the surgeon drills two screws or anchors (60a and 60b)
into adjacent vertebrae. Each screw head contains a hole
through which a connecting rod or brace (90) will be
inserted to effect the desired stabilization. The surgeon
then attaches anchor extensions (30a and 30b) to each
anchor and attaches rod inserter (24) to the proximal end
of the two anchor extensions. Attaching the rod inserter
to the anchor extensions fixes the position of the inserter
with respect to the anchors and fixes the location of the
pivot point (32) and the pivot axis (2) about which the rod
inserter pivots. As the surgeon pivots the rod inserter
about the pivot axis, the device advances the rod or brace
through a small hole in the patient’s skin. The device
pushes the rod along the path defined by arc (A) and into
a corresponding hole (70a and 70b) in each anchor. The
surgeon does not need to expose the patient’s spine or
even to see the vertebrae when inserting the rod, because
the instrument is in rigid alignment with the anchors.
The geometry of the structure ensures that the rod or
brace will follow a predetermined path that will inevita-
bly result in the insertion of the brace through the holes
in the anchors.

II

A

Globus argues that the claims are limited to the sin-
gle embodiment disclosed in the common specification.
We disagree. Although the “Description of the Illustrated
Embodiments” portion of the specification is devoted
mainly to a detailed description of the preferred embodi-
ment and some of its features, nothing in the specification
5 WARSAW ORTHOPEDIC v. GLOBUS MEDICAL

indicates that the invention is limited to that embodi-
ment. To the contrary, the “Summary of the Invention”
describes various “aspects” of the invention in sufficiently
general terms to embrace devices that embody the concept
of the invention but are not identical to the particular
embodiment that is described in great detail. For exam-
ple, the specification provides that in “a further aspect of
the invention,” there is “provided an instrument for
placing a brace or connecting element into a desired
position relative to at least two anchors. The instrument
employs a fixed geometric relationship to guide the con-
necting element into a position proximate the anchors.”
’929 patent, col. 2, ll. 12-16; ’422 patent, col. 2, ll. 17-21.
The specification elsewhere discloses that the “installa-
tion instrument can employ any type of fixed geometric
relationship to insert brace 90 into passageways 70a and
70b. This fixed geometric relationship can be governed
[by] any one or combination of a pinned joint, a cam, a
four-bar linkage, a guide member that provides a path for
translational movement of brace 90, or any other me-
chanical relationship that would occur to those skilled in
the art.” ’929 patent, col. 5, ll. 23-30; ’422 patent, col. 5, ll.
26-33.

As this court has stated, “we have expressly rejected
the contention that if a patent describes only a single
embodiment, the claims of the patent must be construed
as being limited to that embodiment.” Phillips v. AWH
Corp., 415 F.3d 1303, 1323 (Fed. Cir. 2005) (en banc).
Here, the specification does not clearly indicate that the
patentee intended to deviate from the ordinary, broad
meaning of the various terms at issue and limit the scope
of the claims to the disclosed embodiment; indeed, the
specification clearly indicates that the claims are not so
limited. We therefore reject Globus’s restrictive reading
WARSAW ORTHOPEDIC v. GLOBUS MEDICAL 6

of the claims as limited to the preferred embodiment
depicted and described in detail in the specification.

Globus’s specific challenges to the trial court’s claim
construction are tied to its theory that the claims are
limited to the preferred embodiment described in the
specification. Globus argues that the court gave unduly
broad constructions to the terms “instrument” and “in-
serter,” as well as to the phrase “an instrument associated
with the connecting element.”

Globus urged the trial court to construe the term “in-
sertion instrument” to mean “a unitary device for im-
planting a rod or brace that includes a brace inserter, and
which has a pivot axis relative to the anchors that is
located outside the body.” On appeal, Globus contends
that the term “instrument,” as used in the asserted
claims, must include at least “two or more support arms
that are pivotally connected to a brace inserter and each
of which is connected to an anchor extension, or a brace
inserter that is connected to two or more support arms
which are pivotally secured to two or more anchor exten-
sions.” The trial court rejected that complex formulation
and instead construed the term “insertion instrument,”
which is used in the asserted claims of the ’422 patent, to
mean “an implement for inserting something.” As for the
phrase “an instrument associated with the connecting
element,” Globus argued that it should be construed as “a
unitary device for implanting a rod or brace that includes
a brace inserter and a brace, and which has a pivot axis
relative to the anchors that is located outside the body.”
Again, the court rejected that detailed and narrow defini-
tion, but concluded instead that the phrase refers to “an
implement operable to place the connecting element in a
predetermined location.” The court thus construed the
7 WARSAW ORTHOPEDIC v. GLOBUS MEDICAL

phrase to mean “an implement for maneuvering the
connecting element.”

We agree with Warsaw that the patents do not assign
a specific, narrow meaning to the challenged terms and
that the trial court therefore properly construed those
terms in light of their ordinary meanings. Because we
reject Globus’s challenge to the trial court’s construction
of particular terms used in the asserted claims, we uphold
the portion of the court’s judgment that Globus’s accused
system infringes those claims.

B

Globus argues in the alternative that if the claims are
given the broad construction that Warsaw urged for them
during the Markman proceedings, the district court
should have granted its motion for JMOL of anticipation
as to all of the asserted claims.

1. We focus first on the two broadest claims, which
are most vulnerable to Globus’s invalidity challenge.
Those claims, claim 45 of the ’929 patent and claim 42 of
the ’422 patent, are reproduced below:

45. A minimally invasive surgical device,
comprising:
at least a pair of anchors positionable within a
body of a patient;
a connecting element positionable within the
body;
and an instrument associated with the con-
necting element, the instrument being operable to
percutaneously place the connecting element in a
WARSAW ORTHOPEDIC v. GLOBUS MEDICAL 8

predetermined location relative to the pair of an-
chors.

42. A minimally invasive surgical method,
comprising:
positioning at least a pair of anchors within a
body of a patient;
contacting a connecting element with an in-
sertion instrument;
referencing a position of the connecting ele-
ment relative to a position of the pair of anchors;
and
percutaneously inserting the connecting ele-
ment into a desired subcutaneous position relative
to the pair of anchors.

On appeal, Globus argues that the claims as con-
strued are anticipated by an endoscopic surgery per-
formed in the mid-1990’s by its expert witness, Dr. Paul
McAfee. 1 A videotape of that surgery was played for the
jury, and the procedure was described at length by Dr.
McAfee as well as by Dr. Scott Tromanhauser, Warsaw’s
expert witness. Assisted by an endoscopic camera, Dr.
McAfee inserted two screws into the patient’s spine.
Using a grasping instrument, Dr. McAfee inserted a

1 Globus relies on two references on appeal, the
McAfee surgery and U.S. Patent No. 4,448,191 (the ’191
patent). The ’191 patent discloses a surgical technique
requiring incisions that Globus’s expert admitted were
“significant.” All of the asserted claims require a “percu-
taneous” insertion procedure. The district court con-
strued “percutaneous” to mean “through a small incision
or small puncture in the skin.” In light of this distinction,
we decline to set aside the jury’s finding that the ’191
patent does not anticipate the asserted claims.
9 WARSAW ORTHOPEDIC v. GLOBUS MEDICAL

connecting rod through a small hole in the patient’s back
and guided the rod into holes in the two screwheads.
Warsaw’s expert, Dr. Tromanhauser, conceded that the
McAfee procedure discloses most of the elements of claims
45 and 42, including a pair of anchors and the connecting
element. As part of Warsaw’s infringement case, he also
explained to the jury that the “predetermined location”
limitation in claim 45 is met when the surgeon inserts
both screws, dictating the placement of the connecting
rod.

As to the validity of claim 45 of the ’929 patent, the
only issue on appeal is whether the McAfee procedure
discloses the final element, “operable to percutaneously
place the connecting element in a predetermined location
relative to the pair of anchors.” As to the validity of claim
42 of the ’422 patent, the only issue on appeal is whether
the McAfee procedure discloses the step of “referencing a
position of the connecting element relative to a position of
the pair of anchors.”

Globus’s position is that the claims, as construed, re-
quire only that the instrument assist the surgeon in
positioning the connecting element so that it connects the
first and second screws. Warsaw’s position is that the
claims require that the instrument be able to place the
connecting element into the first and second screws
without guidance from the surgeon. It is true, as Warsaw
argues, that the Sextant places the connecting rod in the
proper orientation without the need for the surgeon to
guide the rod between the two screws. Once the surgeon
has placed the anchors in the vertebrae and properly
aligned the inserter, the Sextant will always place the
connector between the holes machined in the anchors.
The critical question for purposes of the validity inquiry is
whether the claims require that the instrument, rather
WARSAW ORTHOPEDIC v. GLOBUS MEDICAL 10

than the surgeon, perform the function of directing the
connecting element along the path between the first and
second screws.

Warsaw contends that none of the asserted claims
read on a method or a device in which the surgeon uses an
ordinary surgical tool to manually insert a rod into the
two screws. At trial, Warsaw’s expert, Dr. Troman-
hauser, distinguished the invention from the McAfee
procedure as follows:

The way I see this is the instrument has an opera-
tion and [the claim is] talking about the capability
of the instrument, not the capability of the sur-
geon. Dr. McAfee’s capability is to grab this rod
with this general purpose instrument and watch
it go into place. That’s not a capability of the in-
strument, that’s a capability of the surgeon. So
the instrument is not operated—the instrument
doesn’t have an operation that places the rod, the
surgeon does.

Warsaw’s position reflects the way the Sextant works,
but it is inconsistent with the limitations in claims 45 and
42, as construed. At Warsaw’s behest, the court con-
strued the final limitation of claim 45 to mean “the in-
strument can be operated to guide the connecting
element, through a small incision or small puncture in the
skin, into a location that is determined in advance.” That
construction does not require the instrument itself to
define the path followed by the rod; under that construc-
tion, the surgeon can use the instrument to guide the rod
by sight or feel from the first screw to the “location that is
determined in advance,” i.e., the second screw. That is
precisely what the McAfee surgery discloses. The McAfee
11 WARSAW ORTHOPEDIC v. GLOBUS MEDICAL

procedure therefore anticipates claim 45 of the ’929
patent under the trial court’s construction.

The McAfee procedure anticipates claim 42 of the ’422
patent for similar reasons. Warsaw argues that the
“referencing” limitation requires that “the instrument
establishes the position of the rod relative to the screws.”
But that argument is inconsistent with the trial court’s
construction of the phrase “referencing a position of the
connecting element relative to a position of the pair of
anchors.” At Warsaw’s urging, the trial court construed
that limitation to mean “establishing the position of the
connecting element relative to the position of the pair of
anchors.” Nothing about the court’s construction of any of
the steps of method claim 42 requires that the “referenc-
ing” or “inserting” step be performed by an instrument
with little to no input or guidance from the surgeon, as
opposed to by a surgeon who uses a general purpose tool
to guide the connecting element by sight or feel. Thus,
because the court’s construction allows the referencing
step to be performed either by the surgeon, as in the
McAfee procedure, or by an instrument that is aligned by
the surgeon, as in a procedure in which the Sextant is
used, the McAfee procedure satisfies that limitation and
therefore anticipates claim 42 of the ’422 patent. 2

2 At closing argument, counsel for Warsaw argued
that claim 45 of the ’929 patent refers “to a capability of
the instrument,” and that the “instrument itself serves as
a guide.” Counsel argued that the “referencing element”
of claim 42 of the ’422 patent “requires some sort of me-
chanical capability to get the rod . . . in the right place.”
While those remarks suggest a narrower construction of
those claims, we cannot substitute counsel’s argument for
the broader construction given by the court and provided
to the jury to guide its deliberations.
WARSAW ORTHOPEDIC v. GLOBUS MEDICAL 12

Warsaw argues that the referencing step must be per-
formed by the instrument or the final “insertion” step
would be redundant. That is not the case. As construed
by the court, the referencing step requires that someone
or something—the surgeon or the instrument—establish
the desired position of the connecting element by refer-
ence to the two anchors. The insertion step requires
placement of the anchor through a small hole in the
patient’s skin and into the desired position. It is therefore
distinct from the referencing step. Because the McAfee
procedure discloses all elements of claim 45 of the ’929
patent and claim 42 of the ’422 patent, we reverse the
district court’s denial of Globus’s JMOL for invalidity on
the basis of anticipation.

2. We take a different view as to the remaining
claims, and we affirm the court’s decision to deny Globus’s
motion for JMOL with respect to claims 47 and 74 of the
’929 patent and claim 48 of the ’422 patent. Claim 47
depends on claim 45 and requires that “the instrument
comprises a mechanical guide for directing the connecting
element along a predetermined path.” ’929 patent, col.
18, ll. 55-58. The trial court explained that “the meaning
of claim 47 is clear: the instrument includes an apparatus
that can mechanically guide the connecting element along
its path to its ultimate location rather than simply plac-
ing the connecting element in the predetermined loca-
tion.” Claim 74 of the ’929 patent requires that the
inserter be referenced to the anchors and that the inserter
itself function to move the connecting element along a
predetermined path. Similarly, method claim 48 of the
’422 patent requires “an insertion instrument referenced
to the pair of anchors.” Those limitations clearly distin-
guish these three claims from the McAfee prior art proce-
dure in which the surgeon, not the instrument, performs
the critical referencing and guiding functions. Accord-
13 WARSAW ORTHOPEDIC v. GLOBUS MEDICAL

ingly, the district court properly sustained the jury’s
finding that claims 47 and 74 of the ’929 patent and claim
48 of the ’422 patent are not invalid.

In sum, we reverse the judgment as to claim 45 of the
’929 patent and claim 42 of the ’422 patent. We affirm the
judgment as to claims 47 and 74 of the ’929 patent and
claim 48 of the ’422 patent. We remand this case to the
district court to determine if the calculation of damages
must be reevaluated in light of the modification of the
judgment.

Each party shall bear its own costs for this appeal.

AFFIRMED-IN-PART, REVERSED-IN-PART, AND
REMANDED