Koninklijke Philips Electronics N.V. et al v. Zoll Medical Corporation
Filing
106
Judge Nathaniel M. Gorton: ORDER entered. MEMORANDUM AND ORDER(Moore, Kellyann)
United States District Court
District of Massachusetts
KONINKLIJKE PHILIPS ELECTRONICS
N.V., PHILIPS ELECTRONICS NORTH
AMERICA CORPORATION,
Plaintiffs,
)
)
)
)
)
)
v.
)
)
ZOLL MEDICAL CORPORATION
)
Defendant,
)
___________________________________)
Civil No.
10-11041-NMG
MEMORANDUM & ORDER
GORTON, J.
I.
Background
A. The Parties
On June 18, 2010, Philips Electronics North America
Corporation, a Delaware corporation with its principal place of
business in Massachusetts, and its parent company Koninklijke
Philips Electronics N.V., a Dutch corporation with its principal
place of business in the Netherlands, (collectively, “Philips”)
filed a patent infringement suit against ZOLL Medical Corporation
(“ZOLL”), a Massachusetts corporation with its principal place of
business in Massachusetts.
Philips’ complaint, in 15 counts, is for infringement of
U.S. Patent No. 5,607,454, No. 5,721,482, No. 5,735,879, No.
5,749,905, No. 5,773,961, No. 5,800,460, No. 5,803,927, No.
5,836,978, No. 5,879,374, No. 6,047,212, No. 6,178,357, No.
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6,304,783, No. 6,356,785, No. 6,441,582 and No. 6,871,093, which
relate to components of automated external defibrillators
(“AEDs”).1
Philips seeks a declaration that ZOLL is infringing
the patents-in-suit, equitable relief, including an injunction,
and monetary damages.
In a related, later-filed case, ZOLL brought suit against
Philips for five counts of patent infringement of U.S. Patent No.
5,330,526, No. 5,391,187, No. 5,470,343, No. 5,575,807 and No.
RE39,250, which also relate to components of defibrillators and
supplemental products, including electrodes and power supplies.
ZOLL seeks a declaration that Philips is infringing the ZOLL
patents-in-suit, equitable relief, including an injunction, and
damages.
In August, 2011 the two cases were consolidated.
The parties submitted 35 claims for construction.
The Court
issued an order requesting that the parties narrow the claims for
construction to 16.
The Court conducted a Markman hearing on
October 25, 2012 at which counsel offered arguments in support of
their proposed claim construction of 15 disputed terms.
The
following is the Court’s ruling with respect to those terms.
B.
The Technology
1.
Philips’ ‘454, ‘879, ‘905, and ‘978 Patents
Six of Philip’s patents (‘454, ‘879, ‘905, ‘978, ‘212 and
‘927) are referred to as the “waveform patents” because they
1
Hereinafter each patent will be referred to by its last three numbers.
-2-
relate to the electrical signal (or “waveform”) that shocks the
patient.
External defibrillators deliver energy to a patient’s heart
via electrodes applied to the surface of the patient’s torso.
Due to physiological differences among patients, the resistance
to the flow of electricity through the tissue between the
defibrillator electrodes and the patient’s heart (“impedance”)
varies from patient to patient depending on the conductivity of
their tissues.
The intensity of the shock delivered to the heart
by the defibrillator can also vary depending on that impedance.
A shock that is effective to treat a low-impedance patient may
not be effective to treat a high-impedance patient.
Prior art defibrillators required the operator to shock the
patient first with an energy level appropriate for the average
patient.
If the first shock did not work, the operator could
then raise the energy level and keep trying.
The ‘454, ‘879,
‘905 and ‘978 patents overcome that problem by providing an
external defibrillator that automatically compensates for the
different levels of impedance in individual patients in real time
by measuring the patient’s impedence and adjusting the discharge
accordingly.
2.
Philips’ ‘212 Patent
The particular waveform described in the waveform patents
above is “biphasic.”
With a biphasic waveform, the system flips
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a switch midway to change from positive voltage to negative.
Biphasic waveforms had been used in implanted defibrillators but
until this patent there was no circuitry that could generate the
biphasic waveform at the higher voltages required by external
defibrillators.
The ‘212 patent discloses a circuit that can
deliver the biphasic waveform at the higher voltages required by
an external defibrillator.
3.
Philips’ ‘374 and ‘460 Patents
The ‘374 and ‘460 patents (“the self test patents”) cover an
external defibrillator that can perform self tests to ensure it
is functional and ready to use.
Prior art external
defibrillators were generally designed for hospitals where
equipment is frequently tested and maintained.
Portable
defibrillators designed for a home or office are much less
frequently tested and thus might not be functional when needed.
The ‘374 and ‘460 patents disclose a defibrillator that conducts
automatic self tests, some while switched “on” and others while
switched “off.”
After the test, the defibrillator indicates the
result “visually and audibly.”
The patents also describe a
“system monitor” that performs the various functions of the self
tests.
4.
Philips’ ‘093 Patent
The ‘093 patent is directed to a defibrillator that includes
an indicator (audible, visual or both) that reports whether the
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defibrillator is functioning properly.
The indicator can be
activated automatically or in response to a "user-triggered
inquiry.”
5.
Philips’ ‘785 Patent
The ‘785 patent is directed to a defibrillator that uses
voice and visual prompts to instruct the user on how to perform
CPR correctly because the steps of CPR are often forgotten, even
by trained professionals.
The covered defibrillator also
monitors the heart rhythm of the patient to determine whether it
is treatable by shock and, if so, prompts the rescuer to deliver
CPR and follow the shock protocol.
6.
ZOLL’s ‘187 Patent
The ‘187 patent is directed to a semi-automatic
defibrillator which has an alarm.
In previous defibrillators the
alarm was activated by either the heart rate (“averaged QRS
rate”) or a shock advisory to indicate to the operator whether
the electrocardiogram shows an abnormal heart rhythm of the sort
that can be corrected by defibrillation shock.
The ‘187 patent
is directed to an alarm based on both of these inputs.
7.
ZOLL’s ‘807 Patent
The ‘807 patent relates to a power supply that provides an
“AC disconnect alarm.”
Because a defibrillator is used in
emergency situations it is crucial that it is charged when
needed.
Thus, as the patent explains, “to ensure[] that a
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battery of the defibrillator will not inadvertently be left
uncharged” the power supply “produces an alarm when it is not
connected to a source of AC power.”
Because this alarm would be
distracting during actual emergencies, the alarm signal is only
produced when the defibrillator is switched off.
8.
ZOLL’s ‘250 Patent
The ‘250 patent is related to ZOLL’s ‘526 patent and is
directed to an "electrode package."
Inside the package is a
"conductor" that is
covered with a water based, conductive adhesive gel that
contacts a patient's skin and electrically connects the
electrode to the patient.
The package is an "envelope" formed from a sheet of material
folded in half that opens like a book.
It provides quick and
easy access to the electrodes but also protects them when it is
closed.
9.
ZOLL’s ‘526 Patent
The ‘526 patent is related to the ‘250 patent and also
concerns defibrillation electrodes.
These electrodes are gel-
covered discs that are placed on the patient’s chest.
This
patent covers a gel arrangement with an electrical resistance
that allows for effective shock treatment while also making it
less likely that the patient will be burned.
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III. Analysis
A.
Principles of Claim Construction
In analyzing a patent infringement action, a Court must
1) determine the meaning and scope of the patent claims asserted
to be infringed and 2) compare the properly construed claims to
the infringing device. Markman v. Westview Instruments, Inc., 52
F.3d 967, 976 (Fed. Cir. 1995) (en banc), aff’d, 517 U.S. 370
(1996).
The first step, known as claim construction, is an issue
of law for the court to decide. Id. at 979.
The second step is
determined by the finder of fact. Id.
The Court’s responsibility in construing claims is to
determine the meaning of claim terms as they would be understood
by persons of ordinary skill in the relevant art. Bell Atl.
Network Servs., Inc. v. Covad Commc’ns Grp., Inc., 262 F.3d 1258,
1267 (Fed. Cir. 2001).
The meaning of the terms are initially
discerned from three sources of intrinsic evidence: 1) the claims
themselves, 2) the specification and 3) the prosecution history
of the patent.
See Vitronics Corp. v. Conceptronic, Inc., 90
F.3d 1576, 1582–83 (Fed. Cir. 1996).
The claims themselves define the scope of the patented
invention.
See Philips, 415 F.3d at 1312.
Claim terms are
generally given their “ordinary and customary meaning”, which is
the meaning that a person skilled in the art would attribute to
the claim term.
See id. at 1312-13.
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Even if a particular term
has an ordinary and customary meaning, however, a court may need
to examine the patent as a whole to determine if that meaning
controls.
Id. at 1313 (“[A] person of ordinary skill in the art
is deemed to read the claim term ... in the context of the entire
patent....”); see also Medrad, Inc. v. MRI Devices Corp., 401
F.3d 1313, 1319 (Fed. Cir. 2005) (noting that a court cannot
construe the ordinary meaning of a term “in a vacuum”).
Ultimately, the correct construction will be one that “stays true
to the claim language and most naturally aligns with the patent's
description of the invention ....”
Id. at 1316 (citation
omitted).
The patent specification is
the single best guide to the meaning of a disputed term
[because it may reveal] a special definition given to a
claim term that differs from the meaning it would
otherwise possess [or contain] an intentional disclaimer,
or disavowal, of claim scope by the inventor.
Phillips v. AWK Corp., 415 F.3d 1303, 1314 (Fed. Cir. 2005) (en
banc).
The Court should also consult the prosecution history to
see how the inventor and PTO understood the patent and to ensure
the patentee does not argue in favor of an interpretation it has
disclaimed.
Id. at 1317.
In the rare event that analysis of the intrinsic evidence
does not resolve an ambiguity in a disputed claim term, the Court
may turn to extrinsic evidence, such as inventor and expert
testimony, treatises and technical writings.
-8-
Id. at 1314.
Although extrinsic evidence may be helpful in construing claims,
the intrinsic evidence is afforded the greatest weight in
determining what a person of ordinary skill would have understood
a claim to mean.
B.
Id. at 1324.
Disputed Terms
1. Monitoring/monitoring. . .during (Philips’ ’454,
’879, ’905, ’978 Patents)
The dispute centers on whether monitoring must occur
continuously throughout the discharge step, as ZOLL contends, or
only one or more times during the discharge step, as Philips’
contends.
ZOLL requests that the Court adopt the ordinary meaning of
monitoring, which it asserts, has a notion of “ongoingness.”
ZOLL argues that because the “discharge step” (construed below)
takes place over time, “monitoring” must also occur over a period
time and cannot be only a single measurement during the step.
ZOLL further asserts that the ‘454 patent actually distinguishes
prior art models because they merely “measured” patient impedance
and did not continually monitor impedance in “real time.”
As a
result, ZOLL requests that the Court construe the term as
“sampling on a regular or ongoing basis” because this definition
is the term’s ordinary meaning according to the American Heritage
Dictionary.
Philips, however, argues that ZOLL’s reliance on a single
dictionary definition ignores the intrinsic evidence.
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As a
result, Philips requests that the Court adopt the construction
that the United States District Court for the Western District of
Washington selected in construing “monitoring” as “measuring...
one or more times.” Koninklijke Philips Elec.s NV v. Defibtech
LLC, 397 F. Supp. 2d 1257 (W.D. Wash. 2005).
The Difibtech Court noted that “monitoring” and “measuring”
are both used in related Philips patents.
Generally, using
different terms raises an inference that the terms have different
meanings, but that inference is not determinative. Desper Prods.,
Inc. v. QSound Labs, Inc., 157 F.3d 1325, 1337 n. 3 (Fed. Cir.
1998).
The Difibtech Court concluded that because “both
measuring and monitoring occur during periods of time” in the
Philips patents, there is “little reason to assume that one term
excludes single measurements and one does not.” Defibtech 397 F.
Supp. 2d at 1264.
As a result, the Court construed “monitoring”
during the discharge step to require only a “single measurement.”
Id.
The Defibtech Court determined that if “monitoring” were
construed as covering only a single measurement, it would require
reading out preferred embodiments.
Reading out preferred
embodiments is an approach that is “rarely, if ever, correct.”
Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1583 (Fed.
Cir. 1996).
Each of the six waveform patents, discloses an
invention the preferred embodiment of which has three “aspects.”
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Depending on the patient’s impedance, one of the three aspects
requires only a single measurement.
As a result, the patent must
cover single measurements as well as ongoing monitoring.
Accordingly, this Court adopts the construction “measuring . . .
one or more times.”
2. The discharge step/the discharging step
ZOLL requests that the Court construe “discharge step” to
make clear that it is “not a test pulse to measure patient
impedance.”
The Court believes that by requesting the addition
of that negative limitation to the claim term, ZOLL is proposing
that the Court resolve an infringement question during claim
construction.
Doing so would contradict the purpose of a Markman
hearing because “the role of the district court in construing
claims” is not to “read limitations into the claims to obviate
factual questions of infringement.” Am. Piledriving Equip. v.
Geoquip, Inc. 637 F.3d 1324, 1331 (Fed. Cir. 2011).
Court declines to adopt ZOLL’s construction.
Here, the
Instead, the Court
adopts the plain meaning of the term and construes it to mean
“the step of discharging the energy source.”
The Court notes, however, that during prosecution the
patentee equated “discharge” with “shock” in describing prior
art.
That suggests that the “discharge step” was not intended to
describe every possible delivery of energy from the energy
source.
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3. Plurality of electronic switches (Philips’ ’212
Patent)
Philips requests that the Court adopt the same construction
of this term as did the Court in Defibtech II, which limited the
term to the “five-switch configuration disclosed in the
specification.” Koninklijke Philips Elect. NV v. Defibtech LLC,
C03-1322JLR, 2005 WL 3500783, at *4 (W.D. Wash. Dec. 21, 2005)
(Defibtech II).
Philips asserts that both the patent examiner
and the applicants understood a “plurality of electronic
switches” to refer to the five-switch circuit in Figure 11.
In Defibtech II the court held that although the patentee
disavowed the prior art five-switch configuration contained in
the Swanson patent, the “inventors did not...expressly limit the
invention to the five-switch configuration that they disclosed in
their patent application.” 2005 WL 3500783 at *3.
At the Markman
hearing in the present case both parties agreed that the
statements made during prosecution of the ‘212 patent do not meet
the standard for a “clear and unmistakable” surrender necessary
to reject the ordinary meaning.
Omega Eng’g, Inc. v. Raytek
Corp., 334 F.3d 1314, 1323-26 (Fed. Cir. 2003).
In Defibtech II
the Court relied on extrinsic evidence including an expert
declaration and inventor testimony to reach the conclusion that
“plurality of switches” could only cover the five switch
configuration contained in Figure 11.
Neither of those pieces of
extrinsic evidence are, however, before this Court which
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therefore declines to adopt that construction.
In Defibtech II, Philips argued contrary to its current
position, noting that to construe the “plurality of electronic
switches” to cover only the five switch embodiment is
contrary to the plain, ordinary definition of the word
plurality, which means two or more. ‘Plurality’ does not
mean ‘only five’ or ‘five or more.’
This Court agrees.
Because the ordinary meaning of plurality is
clear to a jury, the term does not require construction.
4. Prior to any attempted use of the defibrillator
(Philips’ ’374 Patent)
The parties dispute the meaning of “attempted use” and thus
disagree over when the self test must occur.
The parties do
agree that self tests performed while the defibrillator is turned
off fall within the scope of the applicable claims.
The
contested issue is, however, whether “prior to any attempted use”
includes self tests that are performed after the defibrillator is
turned on but before attempted use to treat a patient.
Philips
asserts that the self test must be performed before the
defibrillator is turned on.
Zoll proposes a construction in
which the self test can occur at any point after the
defibrillator is turned on but before it is used to treat a
patient.
This Court agrees with the Defibtech Court that
It makes little difference what the phrase ‘prior to any
attempted use’ means, because the claims in which it
appears impose modifications that resolve the parties’
disputes.
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397 2d. at 1268.
As a result, the Court will examine the precise
use of the term in each of the Claims in which the term appears.
Claim 41 teaches a “periodic test signal generator.” Claim
42 states that the test signal will be generated “periodically.”
According to the “detailed description of the preferred
embodiment” in the ‘374 Patent these periodic self-tests occur
daily, weekly or monthly, even when the defibrillator is turned
off.
Thus, “by their nature, these tests occur before any use of
the defibrillator, including merely turning the device on.” Id.
1269.
As a result, the Defibtech court construed the term when
used in Claims 41 and 42 to mean “prior to any attempted use of
the defibrillator, even non-therapeutic uses.”
Although this
Court is persuaded by the same reasoning adopted in Defibtech, it
prefers the more easily understood construction “prior to an
operator turning on the defibrillator.”
In Claim 67 the language requires that the generation of a
test signal occur “without human intervention.”
As a result,
that language must also refer to one of the periodic self-tests
and the status indication must occur prior to turning on the
defibrillator.
Thus, the Court adopts the same construction as
in Claims 41 and 42 where “prior to any attempted use” means
“prior to an operator turning on the defibrillator.”
Claims 1 and 67 require a different construction.
Claim 1
does not indicate which of the multiple types of self-test in the
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‘374 Patent is required.
Claim 1 does not require all of the
tests, instead, it requires only one.
As the Defibtech Court
described, a defibrillator that was designed to conduct a “run
time” test and to monitor the defibrillator “continually” would
not reveal its status before it was turned on, even though
turning it on is a “use.” Id. at 1269.
Similarly, a
defibrillator that could conduct a manual self-test could not
indicate its status prior to such a test, even though this test
is itself a “use.” Id.
Thus, it is clear that Philips’ proposed
construction “prior to an operator turning on the defibrillator”
does not accurately express the meaning of this term.
The Defibtech court found that
the only “uses” of the defibrillator for which the
invention of Claim 1 would invariably have means to
provide an indication of pre-use status are uses in
treating a patient.
In the case of a defibrillator capable of running a randomly
selected self-test the device would only be guaranteed to
“indicate status before anyone used it to treat a patient,
but not necessarily before other uses.” Id.
It is clear,
therefore, that in some instances “prior to any attempted
use” means “prior to use to treat a patient.”
In the case
of a defibrillator with means to perform a run-time test,
however, the term means “prior to an operator turning on the
defibrillator.”
Therefore, with respect to these Claims,
the Court adopts the construction “prior to any attempted
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use of the defibrillator to treat a patient, and in some
cases prior to an operator turning on the defibrillator.”
Claim 44 requires a test signal generated
“automatically in response to a predetermined event or
condition.”
This Claim includes at least one kind of self-
test but does not include the “periodic” self-tests. This
Court agrees with the reasoning in Defibtech that if the
test is a “run-time” test the status could not be indicated
before the defibrillator was turned on.
Id.
As a result,
the Court applies the same construction as in Claim 1.
5. Test signal (Philips’ ’374, ’460 Patents)
The dispute surrounding the construction of “test
signal” also relates to the Defibtech court’s prior
construction of the term.
In that case, the court
acknowledged that the patent claims are “inconsistent” in
the use of the term “test signal.” Id. at 1267.
As a
result, the court construed most instances of “test signal”
to mean “a signal associated with testing,” but in some
instances found that “additional claim language limits the
term to a ‘signal that initiates testing’.” Id.
ZOLL
requests that the Court adopt the Defibtech Court’s
construction while Philips argues that “a signal associated
with testing” is the better construction because it is one
that “a jury can apply uniformly across the board, yet still
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be understood within the context of each claim.”
The Defibtech court found that the claims in the ‘460
and ‘374 patents fell into three classes.
Id.
First, in
claims that “expressly disclose one or more self-tests
performed ‘in response’ to the test signal or other
stimuli”, “the test signal is a signal that initiates a
test, not one that performs it.” Id.
Second, in claims
where the test signal is generated by the system monitor,
the test signal is also one that initiates testing. Id.
Finally, in the third category where the test signals are
neither used to initiate self-testing nor generated by the
system monitor, the “test signal” is simply “a signal
associated with testing.” Id.
Thus, although “signal
associated with testing” applies in the third category, the
other two categories require the additional limitation of “a
signal that initiates testing.”
While generally “the same claim term used in the same
patent ‘carries the same construed meaning’” this rule
applies only if the court is not “otherwise compelled.”
Omega Eng’g, Inc. v. Raytek Corp., 334 F.3d 1314, 1334 (Fed.
Cir. 2003).
Here, this Court agrees with the ruling in
Defibtech that the limitations in several of the claims
require the court to reach two different constructions of
“test signal.”
As a result, the Court construes this term
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to mean the following:
Construction
Patent
Claims
“A signal that
initiates
testing”
‘374
22, 25-27, 42, 44-45,
51-52, 61-62, 64-65,
67-69, 71-72
“A signal that
initiates
testing”
‘460
1-6
“A signal
associated
with testing”
‘374
1-6, 10, 21, 34-37,
41, 43
6. A heart rate alarm circuit in which the inputs
comprise an averaged QRS rate and the shock
advisory indication (ZOLL’s ’187 Patent)
The Summary of the Invention in ZOLL’s ‘187 Patent states
that it features “an alarm driven by both a heart rate detector
and a fibrillation/tachycardia advisory algorithm.”
This
distinction sets the ‘187 patent apart from prior art in which
alarms were based on only one of those inputs.
Philips requests
that the word “both” be added to the claim construction to make
this distinction clear.
The Court finds, however, that the claim
language is already clear that both inputs are required and is
capable of being understood correctly by the jury.
As a result,
the Court declines to construe this term.
7. Generate an alarm when the monitoring circuitry
determines that the external power connection is not
connected to a source of external power and that the
medical device to which the power supply may be
connected is not turned on/Generating an alarm when the
external power connection is not connected to the
external power source and the medical device is not
-18-
turned on (ZOLL’s ’807 Patent)
Philips argues that the alarm circuitry is configured to
generate an alarm “as a result of” the monitoring circuitry
determining that the device is both not connected to external
power and not turned on.
Philips asserts, therefore, that unless
the Court construes “when” to mean “as a result of” the causal
connection will not be clear to the jury.
The Court finds that the patent does not, however, require
that the alarm actually be triggered by the two events but only
that the alarm function when the two events occur.
Thus, if the
power supply is connected to AC power and the defibrillator is
turned on the power supply will be prevented from activating the
alarm.
Because the patent language already makes this
relationship clear the Court declines to construe it further.
8. A method of supplying power from an external power
source to a battery-powered medical device for charging
a battery of the medical device and operating the
medical device (ZOLL’s ’807 Patent)
Philips requests that the Court construe the claim language
to add the words “by a power supply” to make “the method of
supplying power” clear to the jury.
This Court, however, agrees
with ZOLL that the inclusion is unnecessary.
The language in
Claim 15 already indicates that “the method of supplying power”
includes “providing a power supply.”
As a result, the additional
inclusion is superfluous and the Court declines to construe this
term.
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9. Power supply (ZOLL’s ’807 Patent)
ZOLL argues that “power supply” is a common term that
requires no construction.
This Court agrees with Philips,
however, that the term requires construction to improve juror
comprehension but declines to adopt Philips’ proposed
construction, particularly the inclusion of the words “connects
to a source of AC power.”
the actual invention.
That language is too narrow to address
For example, Claim 1 recites a “connection
for bringing external power into the power supply.”
Such
language suggests that the power supply does not always connect
directly to a source of AC power.
Instead, the Court relies on
the patent specification to adopt the construction “a unit that
connects to a device and that supplies power to the device.”
10. Envelope comprising a sheet of material (ZOLL’s
’250 Patent)
The underlying dispute over the two claim terms in the ‘250
patent relates to whether the “envelope” must be fully enclosed.
ZOLL asserts that the term should be given its “ordinary meaning”
and thus does not require construction.
Philips, on the other
hand, relies on the purpose of the invention to argue that an
envelope must be an “enclosure.”
This Court agrees with Philips
and construes the term to mean “a sheet of material that forms an
enclosure.”
Claim 1 teaches that the envelope has a releasable “seal”
that forms a “sealed first compartment” and allows the electrodes
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to be “isolated from an external environment.”
This isolation is
described as necessary to “prevent[] the adhesive gel from drying
out.”
The Court is persuaded that if the envelope did not
“enclose” the electrodes, the gel would dry out and the invention
would not work as described.
As a result, the Court finds that
the “envelope” is an enclosure.
11. Seal (ZOLL’s ’250 Patent)
This term is closely related to the “envelope” construed in
the proceeding section.
ZOLL argues that the seal need only
provide a “barrier” that serves as “something that closes the
envelope by joining parts of it together.”
This construction,
however, ignores the purpose of the invention. As Philips points
out, a porous barrier could still join the parts together but
would not serve the purpose of the invention.
If the seal is not
airtight, it will not “isolate the electrode from the external
environment” as the patent requires.
Further, the ‘250 patent uses the terms “seal” and “barrier”
differently.
For example, in Claim 13 the “gasket” that allows
the wires that connect to the electrode to pass through the
envelope is described as a “barrier element”.
Because the gasket
allows items to pass through, it is not airtight.
That word
choice suggests that the patentee chose the term “seal” to
distinguish from other non-airtight barriers within the same
invention.
The seal is also repeatedly described as a “heat
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seal”, which is further evidence that it is intended to be
airtight.
As a result, the Court construes “seal” to mean an
“airtight barrier.”
12. A concentration of an electrolyte that produces a
combination series resistance of two of said
electrodes, when measured with the electrodes
configured in a series circuit with a 50Ù resistance,
and with the electrolytic gel layer of each electrode
in contact with that of the other electrode, that is
greater than 1Ù when a 200 Joule defibrillation pulse
is discharged into the series circuit (ZOLL’s ’526
Patent)
ZOLL asserts that no construction is needed. Philips,
responds however, that Claim 1 of the ‘526 patent is indefinite
because there is no explanation “for how one skilled in the art
would choose specific testing conditions to determine whether the
resistance of a given gel electrode is ‘greater than 1Ù’.”
A
term is indefinite where the product “might or might not infringe
depending on its usage in changing circumstances.” Geneva Pharms.
Inc. v. GlaxoSmithKline PLC, 349 F.3d 1373, 1384 (Fed. Cir.
2003).
According to Philips, gel electrodes are tested under the
industry standards for defibrillators set by the Association for
Advancement of Medical Instrumentation (AAMI).
These standards
include a variety of test conditions including the temperature of
the gel, the amount of time the gel has been exposed to air
(humidity) and the number of shocks delivered through the gel.
The ‘526 patent does not, however, specify the test conditions
-22-
necessary to determine whether the claim limitation is met.
Philips conducted testing under a variety of temperature
conditions.
At 35° centigrade (“C”) the resistance did not
exceed 1Ù but at 15C it did.
Thus, depending on the temperature,
the same gel electrode may or may not infringe Claim 1.
Philips
also conducted tests with varying degrees of dryness in the
electrode gel and number of shocks to the electrode and elicited
results that both did and did not infringe Claim 1.
ZOLL contends that the testing conditions are apparent to a
skilled artisan who would know that when testing conditions are
not specified the tests should be conducted at room temperature,
shortly after removing the electrodes from their packaging and
without performing numerous previous shocks.
Furthermore, ZOLL
argues that Philips fails to mention that the AAMI standards do
not include any requisite parameters and thus describe as much as
the ‘526 patent does.
Finally, ZOLL asserts that descriptions of
electrode resistance tests that do not include those parameters
are commonly described in the technical literature.
Patent claims must state with particularity the subject
matter which the applicant regards as his invention. 35 U.S.C.
§ 112.
That definiteness requirement serves a public notice
function and ensures that patent claims will be “sufficiently
precise to permit a potential competitor to determine whether or
not he is infringing."
Amgen Inc. v. Hoechst Marion Roussel,
-23-
Inc., 314 F.3d 1313, 1342 (Fed Cir. 2003) (internal quotation
omitted).
Proof of indefiniteness of patent claims, enough to render a
patent invalid, is met where an accused infringer shows, by clear
and convincing evidence, that a skilled artisan could not discern
the bounds of the claim “based upon the claim language, the
specification, and the prosecution history, as well as her
knowledge of the relevant art area.”
Halliburton Energy Servs.,
Inc. v. M-I LLC, 514 F.3d 1244, 1249-50 (Fed. Cir. 2008).
The
bar is high: “a claim is not indefinite merely because its scope
is not ascertainable from the face of the claims.”
F.3d at 1342.
Amgen, 314
Instead, it must be “insolubly ambiguous” such
that “reasonable efforts at claim construction prove futile.”
Exxon Research & Eng’g Co. v. United States, 265 F.3d 1371, 1375
(Fed. Cir. 2010).
Indeed,
Even if it is a formidable task to understand a claim,
and the result not unanimously accepted, as long as the
boundaries of a claim may be understood it is
sufficiently
clear
to
avoid
invalidity
for
indefiniteness.
Invitogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1383 (Fed.
Cir. 2005) (internal quotation omitted); see also Exxon Research
& Eng’g Co. v. United States, 265 F.3d 1371, 1379 (Fed. Cir.
2001) (“Provided that the claims are enabled, and no undue
experimentation is required, the fact that some experimentation
may be necessary to determine the scope of the claims does not
-24-
render the claims indefinite.”).
Although it is true that “the same principles that generally
govern claim construction are applicable to determining whether
allegedly indefinite claim language is subject to construction,”
Praxair, Inc. v. ATMI, Inc., 543 F.3d 1306, 1319 (Fed. Cir. 2008)
(citation omitted), there are several reasons to defer rulings on
indefiniteness until the summary judgment stage, CSB-Syst. Int’l
Inc. v. SAP Am., Inc., No. 10-2156, 2011 WL 3240838, at *17-18
(E.D. Pa. July 28, 2011).
Those reasons include the fact that an
allegedly infringing party must prove indefiniteness by “clear
and convincing proof” to overcome the statutory presumption of
validity and that
unlike a Markman proceeding that gives meaning to
patent claims, indefiniteness invalidates the
claims entirely. As such, this dispositive effect
is more appropriately tackled at summary judgment.
Id. at *18 (citing numerous instances in which courts elected to
defer indefiniteness until summary judgment).
This is not a case where a defense of indefiniteness is
based upon claims which, on their face, are so vague that they
cannot reasonably be interpreted but rather is a case where the
relevant claims can be construed but are alleged to be indefinite
as applied.
Compare Am. Med. Systs., Inc. v. Biolitec, Inc., 666
F. Supp. 2d. 216, 223 (D. Mass. 2009)(construing a claim as
indefinite where claim language was subject to “multiple
conflicting interpretations”); with Takeda Pharm. Co. v. Handa
-25-
Pharms., LLC, 2012 WL 1243109, at *16 (N.D. Cal. Apr. 11, 2012)
(deferring indefiniteness until summary judgment because whether
a skilled artisan could determine relevant amounts without undue
experimentation was a “largely factual” inquiry).
Here, the
parties’ respective experts offer extrinsic evidence as to
whether the disclosure of the patent is sufficient to allow a
person of ordinary skill to identify the relevant testing
conditions necessary to determine whether the electrode
infringes.
This “battle of the experts” is not, therefore,
properly decided at the claim construction phase.
The Court declines to construe this term. Philips is not,
however, foreclosed from challenging the validity of this claim
for indefiniteness at summary judgment.
13. User-triggered inquiry/user-triggered
indicator (Philips’ ’093 Patent)
The parties agree on the plain and ordinary meaning of
“user-triggered.”
ZOLL, however, requests that the Court add
“regardless of whether the defibrillation capability is active or
not” to its construction.
To support this additional limitation,
ZOLL points to the patent specification which contrasts the
invention with prior art defibrillators because “the present
invention” permits “the user-initiated inquiry to be carried out
whether or not the defibrillator is turned on.”
Philips responds
that defibrillation capability is not dependent upon whether the
defibrillator is turned on.
The Court agrees with Philips and
-26-
construes this term according to its ordinary meaning.
14. Detailed [audio] instructions (Philips’ ’785
Patent)
The dispute over this term relates to the level of “detail”
the instructions require.
The parties agree that the
construction of this term should be informed by the prosecution
history.
The original application recited “prompts” and
“instructions” but not “detailed instructions” and was thus
rejected because such terms were broad enough to encompass the
“sound or flashing light pacing signals” in the prior Lurie
patent.
In response, the applicants amended their application to
include “detailed instructions.”
Philips requests that the Court adopt the construction
[audio] instructions that prescribe a sequence of steps
for reviving a patient, such as (1) deliver a number of
chest compressions, (2) deliver a certain number of
breaths, (3) deliver a certain number of therapeutic
shocks, (4) call 911, and/or (5) clear the patient’s
airway.
To reach that proposed construction, Philips relies on a
statement made by the applicants in response to the original
patent application rejection that:
Various forms of detailed instructions are provided in
the referenced sections of the written description,
including, for example, prompting the caregiver to:
deliver a number of chest compressions, deliver a certain
number of breaths, deliver a certain number of
therapeutic shocks, call 911, and/or clear the patient’s
airway. This level of instruction is not disclosed in
Lurie.
-27-
ZOLL responds that the inclusion of the words “such as” in
Philips’ proposed construction “improperly requires the factfinder to decide subjectively how detailed an instruction must
be.”
This Court agrees and rejects that construction.
ZOLL, instead, requests that the Court adopt the
construction
[audio] instructions that prescribe a sequence of CPR
steps, including the number of times a particular step is
to be taken (if the step is to be repeated).
That construction is based on the series of diagrams in Figures
3-17 that the applicants submitted as part of the amended patent
application.
ZOLL argues that each of those figures “shows a
process by which a user is prompted to administer a CPR step a
particular number of times.”
This Court, however, agrees with
Philips’ contention that the figures are meant only to be
illustrative and were not intended to represent all of the
invention’s functions.
Thus, the Court declines to find that the
“detailed instructions” must include the specific number of times
a step should be repeated.
Furthermore, as the patentee’s statements in prosecution
quoted above indicate, the “detailed instructions” were intended
to include “deliver[ing] a certain number of therapeutic shocks.”
In fact, several of the flow charts in the figures that ZOLL
seeks to rely upon even include a step that asks whether a
particular number of “consecutive shocks have been delivered.”
-28-
At oral argument the parties agreed that the defibrillation shock
is not a “CPR step.”
As a result, ZOLL’s construction fails to
make clear to the jury that the detailed instructions include
both CPR and the invention’s core function of providing
defibrillator shocks.
To address that concern, the Court adopts
the construction “[audio] instructions that prescribe a sequence
of steps for reviving a patient, including CPR and defibrillation
shocks.”
15. Synchronized audible [visual] prompts (Philips’ ’785
Patent)
Both parties agree that “synchronized” should be construed
to mean that the prompts correspond to steps of the “detailed
instructions.”
Philips requests that the Court construe this
term as “audible/visual prompts corresponding to the time at
which the step should be performed.”
ZOLL asserts that “the
step” should instead be construed as “a particular step” because
otherwise Philips’ construction is ambiguous as to which step
corresponds to which time.
ZOLL’s argument is unavailing because
no portion of the patent specification requires the additional
limitation of “a particular step.”
Instead, the specification
states that “the rate of flashing of the visual prompt may
correspond to the timing at which the step, such as CPR, is to be
performed.” (emphasis added). As a result, the Court adopts
Philip’s proposed construction.
-29-
In accordance with the foregoing,
1)
“Monitoring/monitoring. . .during” means:
“measuring . . . one or more times”;
2)
“The discharge step/the discharging step” means
“the step of discharging the energy source”;
3)
The Court declines to construe the term “plurality
of electronic switches”;
4)
“Prior to any attempted use of the defibrillator”
means
“prior to any attempted use of the defibrillator
to treat a patient, and in some cases prior to an
operator turning on the defibrillator” or “ prior
to an operator turning on the defibrillator”;
5)
“Test signal” means
“a signal that initiates testing” in some claims,
and in others, “a signal associated with testing,”
Construction
Patent
Claims
“A signal
that
initiates
testing”
‘374
22, 25-27,
42, 44-45,
51-52, 61-62,
64-65, 67-69,
71-72
“A signal
that
initiates
testing”
‘460
1-6
“A signal
associated
with
testing”
‘374
1-6, 10, 21,
34-37, 41, 43
6)
The Court declines to construe the term “A heart
-30-
rate alarm circuit in which the inputs comprise an
averaged QRS rate and the shock advisory
indication”;
7)
The Court declines to construe the term “Generate
an alarm when the monitoring circuitry determines
that the external power connection is not
connected to a source of external power and that
the medical device to which the power supply may
be connected is not turned on/Generating an alarm
when the external power connection is not
connected to the external power source and the
medical device is not turned on”;
8)
The Court declines to construe the term “A method
of supplying power from an external power source
to a battery-powered medical device for charging a
battery of the medical device and operating the
medical device”;
9)
“Power supply” means
“a unit that connects to a device and that
supplies power to the device”;
10)
“Envelope comprising a sheet of material” means
“a sheet of material that forms an enclosure”;
11)
“Seal” means
“airtight barrier”;
12)
The Court declines to construe the term “A
concentration of an electrolyte that produces a
combination series resistance of two of said
electrodes, when measured with the electrodes
configured in a series circuit with a 50Ù
resistance, and with the electrolytic gel layer of
each electrode in contact with that of the other
electrode, that is greater than 1Ù when a 200
Joule defibrillation pulse is discharged into the
series circuit”;
13)
“User-triggered inquiry/user-triggered indicator”
means
-31-
“an inquiry that the user may trigger”/ “an
indicator that the user may trigger”;
14)
“Detailed [audio] instructions” means
“[audio] instructions that prescribe a sequence of
steps for reviving a patient, including CPR and
defibrillation shocks”;
15)
“Synchronized audible [visual] prompts”
means
“audible/visual prompts corresponding to the time
at which the step should be performed”.
So ordered.
/s/ Nathaniel M. Gorton
Nathaniel M. Gorton
United States District Judge
Dated November 26, 2012
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