St. Jude Medical Cardiology Division Inc. et al v. Volcano Corporation
CLAIM CONSTRUCTION ORDER. Signed by Judge Richard G. Andrews on 5/30/2013. (nms)
IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF DELAWARE
ST. JUDE MEDICAL, CARDIOLOGY
DIVISION, INC., ST. JUDE MEDICAL
SYSTEMS AB, and ST. JUDE MEDICAL
Civil Action No. 12-441-RGA
CLAIM CONSTRUCTION ORDER
The parties having briefed their positions on construction of the claims of United States
Patent No. 6,565,514 (the "'514 patent"), and the Court having conducted a Markman hearing on
May 21, 2013, it is hereby ordered that, as used in the '514 patent, the terms below are construed
"Displaying said graph" is construed to mean "displaying as a set of points, as a
line or line segment, as a curve, or as an area" and "of the data resulting from said calculation" is
construed to mean: in claim 1: "of a ratio PdIP a' which is based on the continuous detection of
heart beats and continuously forming a ratio between two calculated average pressures"; in
claims 14, 16 and 29: "of a ratio of PdIP a"; in claim 24: "of a ratio of Pd /P a from the floating
With respect to the term "displaying said graph," the parties primarily dispute whether a
graph can be a single point, marker, or numerical value. St. Jude's proposed construction of the
term "graph" would include a single point, marker, or numerical value. St. Jude's proposed
construction, however, is inconsistent with the claims and specification ofthe '514 patent. For
example, independent claims 14 and 16 require "marking ... at least one interesting point or
portion on the graph." If a graph could be a single point, there would be no need to graph the
data, the "graph" would not need to be marked, and there could not be a "portion of the graph."
Similarly, dependent claims 15 and 17 require that the marked interesting point be "a minimum
value ofthe displayed graph." There is also no reason to be marking the minimum (or
maximum) value of a graph of a single point because the minimum/maximum value is the single
point. These claims address situations where marking a point is of assistance to the user of the
invention. 1 As the '514 patent explains, "[t]he invented system also comprises an arrangement
for the calculation of FFRmyo values ... and element[ s] being capable of continuously forming a
ratio between two calculated average pressures." '514 patent at col.611.35-41. The patent, thus,
makes clear that the claimed graph is the result of the continuously formed ratio of pressures and
not simply a single point reflecting the minimum value of those computed ratios.
With respect to the term "of the data resulting from said calculation," Volcano argues that
this term is indefinite. The Court disagrees. Each claim teaches what "the data" refers to
because each claim refers to a calculation that produces said data. The Court's construction of
this term, therefore, is consistent with the calculations set forth in the claim language itself.
"Detecting continuously at least two physiological variables, arterial pressure (Pa)
and distal coronary pressure (Pd), derived from the guidewire-mounted pressure sensor" is
construed to mean "arterial pressure (Pa) is continuously detected, and distal coronary pressure
'514 patent at col.711.24-28.
(P d) is continuously detected using a guidewire-mounted pressure sensor." The dispute here is
whether both arterial pressure (P a) and distal coronary pressure (P d) must be measured from a
guidewire-mounted pressure sensor or whether arterial pressure (P) can be measured with a
catheter. 2 Volcano argues that English grammar rules dictate that "derived from guidewiremounted pressure sensor" modifies both arterial pressure (P a) and distal coronary pressure (Pd).
Although Volcano is correct as a matter of grammar/ the Court concludes that a person of
ordinary skill in the art would understand that only the distal coronary pressure is measured with
a guidewire. Claim 1 requires "the continuous detection of heart beats and continuously forming
a ratio between two calculated average pressures" and then averaging the "measured heart
pressure over a number of heart beats." Claim 1, therefore, requires that arterial pressure and
distal coronary pressure be measured within the same heart beat, and the specification explains
that both measurements are taken continuously. Because the continuous measurements take
place within a single heartbeat, the measurements occur effectively simultaneously. The claims,
thus, require at least two pressure sensors to be continuously in position - one distal to the
stenosis and one proximal, usually in the aorta.
The specification also teaches the necessity of having two sensors on two different
devices to measure FFR. The specification discusses calibrating "the two pressure sensors"
before measurement and equalizing the measurements from the two sensors. ld at col.6 1.51 to
Volcano's proposed construction recognizes the "at least two physiological
variables" language but does not complain that St. Jude's proposed construction does not. (D.I.
47 at 55).
The doctrine of last antecedent is, at most, a guideline, not a rule. Finistar Corp.
v. DirecTV Group, Inc., 523 F.3d 1323, 1336-37 (Fed. Cir. 2008).
col. 7 1.3. It would be impossible to equalize two sensors on the same guidewire in the aorta if the
sensors are intended to be spaced apart such that they could simultaneously measure arterial
pressure and distal coronary pressure. Accordingly, a person of ordinary skill in the art would
understand the pressure measurements are not both "derived from the [guidewire] mounted
pressure sensors" but that only the distal coronary pressure must be derived from the guidewiremounted pressure sensor.
"Sensor element" is construed to mean "an assembly of sensing devices." The
term "a sensor element" is found in independent claims 16, 24, and 29. Each of these claims
describes "a sensor element, said sensor element being capable of detecting continuously at least
two physiological variables, arterial pressure (PJ and distal coronary pressure (Pd) and delivering
processable signals to a unit being able to process said processable signals." For the same
reasons that the term "[ d]etecting continuously at least two physiological variables, arterial
pressure (Pa) and distal coronary pressure (Pd), derived from the guidewire-mounted pressure
sensor" includes at least the "[guidewire]/catheter assembly" described in the specification, "a
sensor element" must include a guidewire/catheter assembly and must be comprised of at least
two sensors. Because certain claims refer to a "sensor" and other claims refer to a "sensor
element," these terms should have different meanings. Furthermore, dependent claim 26 requires
that the sensor element be further capable of detecting venous pressure (P v). Neither party has
suggested that a single sensor exists that can detect pressure in a vein while also detecting two
pressures in the heart. Thus, the "sensor element" in claim 26 that can detect three different
pressures must have multiple sensors, not a single sensor.
Volcano argues that the specification supports its proposed construction of "sensor
(See, e.g., id at col.4 11.3-9 ("FIG. 5 discloses a block diagram of a preferred embodiment of a
measurement system 500 according to the invention. Said system comprises a monitoring unit
501, connected to at least two sensor elements 502, each sensor element 502 being capable of
detecting continuously at least two physiological variables, arterial pressure Pa and distal
coronary pressure Pd·"); id at col.4 11.23-27 ("The sensor elements 502 being capable of detecting
continuously at least two physiological variables, arterial pressure Pa and distal coronary pressure
Pd can have separate transducing elements or be designed to deliver a processable signal, without
a transducer element.")). As Volcano points out, in Figure 5, two boxes indicate two sensor
elements 502. If a sensor element includes at least two sensors, Figure 5 should only include one
The conflict between the claim language and Figure 5 is only part of the analysis,
however, because the specification also supports St. Jude's proposed construction. In particular,
the specification provides: "The [sensor] element being capable of detecting continuously Pv can
be a [guidewire]/catheter assembly having transducers, such as pressure sensors attached
thereto." '514 patent at col.5 11.22-25. Thus, the specification distinguishes the sensor element
from the "pressure sensors." Accordingly, the claim language itself as well as the specification
(other than Figure 5) support the Court's construction.
Entered this~ day of May, 2013.
United States District Judge
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