United States District Court, D. Massachusetts
KONINKLIJKE PHILIPS, N.V. and PHILIPS ELECTRONICS NORTH AMERICA CORPORATION, Plaintiffs,
ZOLL MEDICAL CORPORATION, Defendant.
MEMORANDUM AND ORDER
NATHANIEL M. GORTON, District Judge.
Plaintiffs Koninklijke Philips Electronics, N.V. and Philips Electronics North America Corporation (collectively "Philips") bring suit against defendant ZOLL Medical Corporation ("ZOLL") for infringement of six patents directed to cardiac defibrillation technology: U.S. Patent No. 7, 463, 922 ("the '922 patent"), No. 6, 405, 083 ("the '083 patent"), No. 5, 441, 520 ("the '520 patent"), No. 6, 021, 349 ("the '349 patent"), No. 6, 088, 617 ("the '617 patent") and No. 6, 314, 320 ("the '320 patent").
The parties have submitted 21 claims of the several patents for construction. The Court convened a Markman hearing on March 20, 2014 at which counsel offered their proposed construction of 13 disputed claims. The Court's ruling as to those claims follows.
I. Overview of the Patented Technology
The patents-in-suit are directed in some fashion to cardiac defibrillators. Cardiac defibrillators are medical devices that can deliver an electrical shock to a patient who is experiencing ventricular fibrillation ("VF"), i.e. a rapid, erratic heartbeat.
While a defibrillator can be surgically implanted within a patient, the patents-in-suit are directed to external defibrillators that deliver shocks through electrodes placed on the torso of a patient. The electrodes sense the patient's heart rhythm to determine if it is "shockable", i.e. susceptible to correction with a defibrillator. The heart rhythm may be displayed on an electrocardiogram ("ECG").
External defibrillators can have both manual modes and semi-automatic modes. When a defibrillator is operated in manual mode, the operator analyzes the patient's heart rhythm to determine when a defibrillation shock is necessary. In contrast, when the device is operated in semi-automatic mode, a "shock advisory algorithm" evaluates the heart rhythm. Defibrillators with a semi-automatic mode may also issue visual or audio prompts to guide the operator through the rescue. Regardless of the mode, the operator must press a button on the external defibrillator device to deliver a shock to the patient through the electrodes.
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 meanings of the terms are initially discerned from three sources of intrinsic evidence: 1) the claims themselves, 2) the patent 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 Phillips v. AWK Corp. , 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc). 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. 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....
Phillips , 415 F.3d at 1316 (quoting Renishaw PLC v. Marposs Societa' Per Azioni , 158 F.3d 1243, 1250 (Fed. Cir. 1998)).
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.
Id. at 1316, 1321. 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. Id. at 1317. 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. V-Formation, Inc. v. Benetton Grp. SpA , 401 F.3d 1307, 1310-11 (Fed. Cir. 2005).
B. The '922 Patent
1. The Technology
Defibrillators that are operated in semi-automatic mode employ different shock advisory algorithms to determine whether a patient is experiencing VF. One prior art algorithm breaks the ECG into a series of successive, contiguous windows and then analyzes each of those windows using a "voting process" based on data from multiple contiguous windows.
The '922 patent is directed to an algorithm that analyzes overlapping ECG windows rather than successive, contiguous windows. In other words, each window except the first and last overlaps portions of the windows that immediately precede and follow it. The patented technique produces a shock-no shock advisory more quickly than the prior art method employing successive, contiguous windows. It also eliminates "boundary problems" wherein a signal on the edge of two contiguous windows might not be adequately accounted for in the analysis.
2. Disputed Claim Terms
a. wherein a window of one ECG waveform overlaps a portion of the window of at least one other ECG waveform (Claim 1) each of the sections comprising the ECG heart waveform of a period of time which overlaps the time period of another of the sections (Claim 6)
The parties disagree about whether the terms require construction by the Court at all. Philips argues that the disputed terms have clear and unambiguous meanings when viewed against the backdrop of the claim as a whole. ZOLL proposes construing the terms to specify that
at least some of the digital samples of the continuous ECG heart waveform found [in a first window/each section] are present also in the digital samples of the continuous ECG heart waveform found in at least [a second window/one other section].
With respect to the first term in dispute, it is helpful to view it in context of the portion of the claim in which it appears. Claim 1 recites, in relevant part,
a processor unit coupled to the sensor and operable to analyze a plurality of ECG sections of the ECG segment for an indication of VF, each ECG section comprising digital samples of a continuous ECG heart waveform sensed during a window in time, wherein a window of one ECG waveform overlaps a portion of the window of at least one other ECG waveform and the processor is operable to analyze said window of the ECG waveform and said overlapping window of said ECG waveform to determine the indication of said VF....
There is no question that the subject portion of Claim 1 is poorly drafted and, worse, contains terms that do not appear in the specification. It discloses the similar terms "ECG sections", an "ECG segment" and "[an] ECG waveform" without differentiating between them. "ECG waveform", in fact, appears nowhere in the specification, nor does the term "digital samples" as it is used in the claim.
The term in dispute, "wherein a window of one ECG waveform overlaps a portion of the window of at least one other ECG waveform", is an example of particularly problematic drafting. The Court agrees with ZOLL that the natural reading of the disputed term is that at least two ECG waveforms overlap. That reading is perhaps inconsistent with the immediately preceding term which teaches that "a continuous ECG heart waveform [is] sensed over a window of time" and suggests that it is not possible to have overlapping windows of two different ECG waveforms. Adding to the difficulty is the fact that the parties have not provided the Court with constructions of the terms "ECG waveform" and "digital samples" and the terms appear to have been added during the prosecution with no comment. See Amendment After Final Action, Docket No. 110, Ex. 3, at 5-6.
While the Court agrees with ZOLL that the patent, as worded, likely limits the scope of the claim more than the inventors intended, Philips suggests that no construction is required and that the Court should preserve the "careful balance" struck by the applicants and the Patent Office that gave rise to the current wording. The construction proposed by ZOLL, moreover, goes beyond addressing the possible ambiguity. All that would be necessary to clarify the term is to construe it to mean
wherein one window of the continuous ECG heart waveform overlaps a portion of at least one other window of the continuous ECG heart waveform.
In other words, it is unnecessary to construe the claim in terms of "digital samples" to avoid the ambiguity identified by ZOLL. The Court will therefore decline to construe the claim.
The Court also declines to construe the similar but unambiguous term that appears in Claim 6 because it is unnecessary to construe the language in terms of undefined "digital samples". While ZOLL may be correct that some digital samples that fall within one window or section also fall within another window or section, its preferred construction is not compelled by the claims or prosecution history and is certainly not compelled by the specification which omits the term entirely.
b. analyze said window of the ECG waveform and said overlapping window of said ECG waveform to determine the indication of said VF (Claim 1) analyzing the ECG heart waveform sensed during each of the sections (Claim 6)
Philips contends that no construction is necessary because the plain meaning of the disputed terms is clear. ZOLL disagrees and proposes that the Court construe the terms to mean
perform mathematical computations on the digital ECG samples in each window/section to classify said samples as VF (ventricular fibrillation) or not VF.
The Court agrees with Philips that the term "analyze" on its own is clear and declines to construe the term further to mean "to perform mathematical computations on." No such limitation exists in the patent claims, specification or prosecution history. Furthermore, the limitation "to classify said samples as VF (ventricular fibrillation) or not VF" improperly narrows the claim. Portions of the specification that discuss a distinction between analysis and voting in the prior art and certain embodiments do not limit "analysis" to classifying ECG sections as VF or not VF.
ZOLL is correct, however, that the term "analyze" makes no sense when applied to a "window" as recited in Claim 1, in which a window is a period of time. Time cannot be analyzed for the indication of VF. Instead, what is analyzed in Claim 1 is the ECG waveform sensed within each "window" of time where such windows have the property of overlapping with each other. That construction is consistent with Claim 6, which recites "analyzing the ECG heart waveform sensed during each of the sections, " and does not import an additional limitation with respect to the subject or nature of the analysis. As a result, the Court will adopt the following construction with respect to the disputed term in Claim 1:
analyze the ECG waveform sensed during said window and said overlapping window to determine the indication of VF.
The disputed term in Claim 6 requires no construction. It teaches analysis of the ECG waveform and therefore does not suffer from the same lack of clarity as Claim 1.
C. The '083 Patent
1. The Technology
The '083 patent is directed to a defibrillator that communicates wirelessly "live" ECG signals to a remote location. The technology involves transmitting signals from a mobile telemetry transceiver in the defibrillator through a ...