Opinion
Civil Action No. 09-80-LPS-MPT.
February 18, 2011
REPORT AND RECOMMENDATION
I. INTRODUCTION
Plaintiff Masimo Corporation ("Masimo") and defendants, Philips Electronics North American Corporation and Philips Medizin Systeme Böblingen (collectively, "Philips"), manufacture competing pulse oximetry products. Pulse oximetry allows for the non-invasive measurement of blood oxygen saturation. Modern pulse oximeters permit users to monitor patients continuously and in real time. Where previous technology could not provide accurate data in the presence of motion induced "noise," the products manufactured by both Masimo and Philips remove, filter, or circumvent the "noise" to generate more accurate data points.
Masimo initiated this action on February 3, 2009 alleging infringement. In an amended complaint, Masimo alleges that Philips' production, use, and sale of pulse oximeters incorporating Philips' "Fourier Artifact Suppression Technology" as well as Philips' IntelliVue line of patient monitors infringes 14 of Masimo's patents. Philips North America filed counterclaims against Masimo asserting infringement of 10 of Philips' patents through the production, use, and sale of various Masimo monitors, boards, sensors, and oximeters using patent Philips technology. Since the commencement of litigation, the parties have limited their asserted patents. Masimo alleges infringement of U.S. Patent Nos. 6,263,222 ("the `222 patent"), 5,632,272 ("the `272 patent"), 7,215,984 ("the `984 patent"), and 6,699,194 ("the `194 patent"). Philips alleges infringement of U.S. Patent Nos. 6,122,535 ("the `535 patent"), 6,725,074 ("the `074 patent"), and 5,448,991 ("the `991 patent").
On December 1, 2010, the court conducted a Markman hearing on the parties' respective constructions of several disputed terms of the asserted claims. This order sets forth the court's construction of those terms.
Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995) (en banc), aff'd, 517 U.S. 370, 372 (1996).
II. ANALYSIS
1. `222 Patent — Signal Processor (Claim 17)Page 3
A. Analysis of Masimo's Asserted Patents signal processor
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction "a No Construction "A processing unit which responsive to the first and Necessary or, in the determines either a second intensity signals to alternative, "a device that secondary reference n'(t) calculate arterial oxygen processes an input or or a primary reference s'(t) saturation without output signal." for use in a correlation significant interference in canceler, such as an the calculation from the adaptive noise canceler." motion induced noise portion of the first and second intensity signals." The Federal Circuit has found that "[o]ne purpose for examining the specification is to determine if the patentee has limited the scope of the claims." "Where the specification makes clear that the invention does not include a particular feature, that feature is deemed to be outside the reach of the claims of the patent, even though the language of the claims, read without reference to the specification, might be considered broad enough to encompass the feature in question."In the "Detailed Description of the Invention" ("Detailed Description") for the `222 patent, the patentee declares that "[t]he present invention is a processor which determines either a secondary reference n'(t) or a primary reference s'(t) for use in a correlation canceler, such as an adaptive noise canceler." The "Summary of the Invention" ("Summary") similarly states that "[t]he signals are processed via the signal processor of the present invention to acquire either a secondary reference or a primary reference which is input to a correlation canceler, such as an adaptive noise canceler." Later, the Summary again describes "a processor of the present invention [that] removes the primary signal portions from the measured signals yielding a secondary reference . . . [which, along with] at least one of the measured signals are input to a correlation canceler. . . . " Although claim 17 does not explicitly recite the correlation canceler limitation, where the patentee repeatedly states that the described invention is "for use in a correlation canceler," the court is entitled to take the patentee at his word.
D.I. 140, Ex. 1 at 12:61-64.
Id. at 4:54-57.
Id. at 5:30-36.
See Honeywell Int'l, Inc. v. ITT Indus., 452 F.3d 1312, 1318 (Fed. Cir. 2006); see also id. ("Here the written description uses language that leads us to the conclusion that a fuel filter is the `only injection system component' that the claims cover . . . On at least four occasions, the written description refers to the fuel filter as `this invention' or `the present invention.'").
In opposition, Masimo argues that the patentee's use of permissive language suggests that a correlation canceler may or may not be required and, as a result, the patent teaches away from a correlation canceler limitation. The patent states that "[t]he signal processor may comprise a correlation canceler, such as an adaptive noise canceler," and later that "[t]he signal processor may comprise a joint process estimator." However, permissive language stating that the invention "may" be subject to a certain limitation is insufficient to disclaim an otherwise explicit limitation. As a result, the court interprets the term "signal processor" to mean "[a] processing unit which determines either a secondary reference n'(t) or a primary reference s'(t) for use in a correlation canceler, such as an adaptive noise canceler."
D.1. 140, Ex. 1 at 6:31. A "joint process estimator" is a type of adaptive noise canceler. See id. at 6:32-34 ("The adaptive noise canceler may comprise a joint process estimator having a least-squares-lattice predictor and a regression filter.").
Id. at 8:11-12.
Watts, 232 F.3d at 883 (negating permissive language in light of the entirety of the disclosure because the specification never explicitly discussed an embodiment without the proposed limitation).
2. `272 Patent — Signal Model (Claims 9, 14)
1 1 1 2 2 2 1 a 2 1 v 2 a 1 2 v 1 2 1 1 2 2 1 2 signal model. a v
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction "In a signal processor for "The relationship "The signal model defined processing at least first between two by: and second measured physiological signals S = s + n signals, each containing a which follows certain S = s + n primary signal portion and conditions." with s = (r)(s) a secondary signal portion, and n = (r)(n) said first and second or r = (s)/(s) signal substantially and r = (n)/(n) adhering to a predefined signal, a method where s and n are at least comprising the steps of: somewhat (preferably substantially) uncorrelated *** and s and n are at least from said selected at least somewhat (preferably one comparison value, substantially) uncorrelated. determining a resulting The first and second value consistent with the measured signals S and S predefined are related by correlation coefficients r and r as defined above." The court adopts Masimo's proposed construction and determines that "signal model," as used in claims 9 and 14 means "[t]he relationship between two physiological signals which follows certain conditions." The court rejects Philips' construction which would expand an exemplary statement into a definitional statement. Although the Detailed Description states that a signal model in accordance with the present invention is defined as Philips' proposed construction, it later states that "[t]he primary and secondary signals according to this model may be written" as the function of another set of variables. Further alternate relationships between two measured signals are described at 22:31-61, 58:47-59:14, and 59:15-64. Despite the Federal Circuit's finding that "the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess," where the specification specifically mentions alternative signal models, the court will not restrict the claims.3. `272 Patent — "comparing" (Claim 9)
comparing Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction said first and "relating one or more "calculating point-by-point second transformed series points in a first group comparisons of the first and of points to obtain a third with point(s) in a second second transformed signals" series of comparison group to obtain a group values having a magnitude of comparison values component and at least a having a magnitude frequency component; component and at least a frequency component" The court adopts Philips' proposed construction and determines that "comparing," as used in claim 9, refers to "calculating point-by-point comparisons of the first and second transformed signals." While Masimo's proposed construction cites one of the many definitions of "series," from Webster's dictionary as the ordinary definition, that construction overlooks a number of alternative definitions cited in that very reference, and overlooks the context in which the term "comparing" is used in the claim. The Webster's definition states that a "series" may be "a group or number of similar or related things arranged in a row" or "a group or number of related or similar persons, things, or events coming one after another, sequence; succession." Claim 9 states that each series being compared has "at least a frequency component and magnitude component," and that the resulting "series of comparison values [has] a magnitude component and at least a frequency component."Although the specification includes embodiments that use only some of the transformed points, the specification does not require that every point in the first series be compared to every point in the second series. Rather, the specification states that where a comparison is done, that comparison must be done on a frequency-consistent, or a point-by-point, basis.
Id. at 55:14-58:45 (However, a furthertest is performed to qualify the points for which a ratio is taken . . . For those sample points which qualify, a ratio is taken in the ratio module 670."
Id. ("The point-by-point ratio module takes the red over infrared ratio of the values on a point-by-point basis.").
Finally, Masimo argues that the presence of a dependent claim 10, which explicitly states the point-by-point limitation gives rise to a presumption that the limitation is not present in the independent claim 9. Claim 10 states that the "method of claim 9, wherein said step of comparing comprises determining a series of ratios on a point-by-point basis . . . and wherein said step of selecting at least one of said comparison values comprises the step of selecting the lower of the ratios." Where claim 9 requires a comparison of a "transformed series of points," claim 10 requires that these points be "a series of ratios." The dependent claim adds the limitation that the comparison be of a series of ratios and, as a result, claim differentiation is inapplicable.
See Phillips, 415 F.3d at 1315.
D.I. 140, Ex. 6 at 66:26-31.
Id. at 66:10-31.
4. `272 Patent — "determining" (Claim 14)
determining
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction a series of No Construction "calculating point-by-point ratios of magnitudes with Necessary comparisons of the first and respect to frequency of second transformed signals" ones of said first transformed series of points to ones of said second transformed series of points; For the same reasons outlined in the construction of "comparing," the court adopts Philips' proposed construction and determines that "determining a series of ratios," as used in claim 14, refers to "calculating point-by-point comparisons of the first and second transformed signals."5. `984 Patent — "calculation technique" (Claims 1, 52 and 53)
calculation technique calculation technique calculation technique,
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction a first calculator capable of No Construction "A first [or second] algorithm utilizing a first Necessary or, in the based on the disclosed to determine at alternative, "a manner of signal model" least a first value using mathematics to representative of the at make a determination" least one physiological characteristic of the pulsing blood, a second calculator capable of utilizing a second different from the first to determine at least a second value representative of the at least one physiological characteristic, and As a consequence of the court's finding that "signal model" means the "relationship between two physiological signals which follows certain conditions," the court finds that no additional construction is necessary for the term "calculation technique."6. `194 Patent — "Center of Mass" (Claims 11, 14 and 16)
N center of mass i i center of mass calculation center of mass type of calculation
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction The method of claim 10, No construction "a threshold value g for ratio wherein said pulserate is necessary or, in the lines R associated with the estimated according to a alternative, "the first N spectral peaks of at least balancing point" according to the following a portion of said series of formula: spectral peaks. g = N/(summation of 1/R *** from =0 to N — 1)" using results from a of at least a portion of said spectral values to estimate said pulserate *** estimate said pulserate from said series of spectral peaks as a function of a of at least a portion of said series of spectral peaks. Philips' argues that the specification describes only one center of mass calculation. The specification states that "[i]n a preferred embodiment . . . [t]he ratio threshold g is then computed as a modified center of mass for the RN lines according to the" equation outlined in the proposed construction. The Federal Circuit has found that "[i]t is a `bedrock principle' of patent law that `the claims of a patent define the invention to which the patentee is entitled the right to exclude.'" "[A]lthough the specification often describes very specific embodiments of the invention, [the Federal Circuit has] repeatedly warned against confining the claims to those embodiments." The specification describes the computation for a "modified center of mass" according to the equation outlined in Philips' proposed construction, but the claims state that the pulserate may be estimated using "a center of mass," or "a center of mass calculation." Philips' does not provide any statements demonstrating the patentee's intent to limit the general "center of mass" calculation to any singular equation. As a result, the court finds that no construction is necessary for "center of mass."7. `194 Patent — "classifying" terms (Claims 3, 4, 5, 8, 10, 14, 16 and 17)
classifying classifying
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction said three or No Construction "categorizing by matching . . more spectral peaks into a Necessary . to one of the idealized first group comprising one spectra shown by the plots or more spectral peaks 1600, 1610, 1620, 1630, or corresponding to a 1640 in Figs. 16 A-C" fundamental frequency and a second group comprising one or more harmonics of said fundamental frequency; and *** said plurality of spectral peaks into a first group comprising one or more spectral peaks corresponding to a fundamental frequency and a second group comprising one or more harmonics of said fundamental frequency; and The court finds that no construction is necessary for the term "classifying." The specification states that according to one aspect of the invention, "the pulserate can be determined in the presence of FM and AM distortions by classifying the spectrum as one of five categories grouped into three cases. The specification further provides that in accordance with one aspect of the invention, "the pulserate is determined by identifying the largest three spectral lines, then matching the spectrum to one of the idealized spectra shown by the plots 1600, 1610, 1620, 1630, or 1640, and then applying one of a set of rules to determine the pulserate." Philips argues that these passages illustrate that the term "classify" is used in the context of classifying the peaks in the frequency domain. Further, Philips argues that classifying peaks in the frequency domain requires matching the spectrum to one of five plots because this matching is the only rule-based approach disclosed in the specification.Philips recognizes that even when the specification describes only a single embodiment, without more, the claims of a patent will not be read restrictively. However, Philips points to Decisioning.com, Inc. v. Federated Dept. Stores, Inc., for the proposition that where the essence of the patent is restricted to the singular embodiment, the claims cannot enlarge what is patented beyond the inventor's description. Nowhere in the asserted claims (claims 3-5, 8, 10, 14, and 16-17) does the patentee define these "classifying terms" as requiring the matching of spectral peaks to one of the idealized spectra shown in the numbered plots. To the contrary, the patentee directs the patent away from a literal comparison to plots 1600-40 via a statement advising that a person skilled in the art would understand that "although the frequencies of the spectral shown in the plots 1600, 1610, 1620, 1630, or 1640 appear to be harmonically related[, in practice] the spectral lines may not correspond to frequencies which are harmonics." Philips fails to demonstrate the patentee's clear intent requiring a "matching [of] three or more spectral peaks to one of the idealized spectra shown by the [listed] plots." As a result, the court finds that no construction is necessary to clarify the "classifying" terms in claims 3-5, 8, 10, 14 and 16-17.
527 F.3d 1300 (Fed. Cir. 2008).
See D.I. 140, Ex. 5 at 24:28-28:3 (reciting a variation of the requirement to classify a number of spectral peaks into a first group corresponding to a fundamental frequency and a second group comprising one or more harmonics of that fundamental frequency).
D.I. 140, Ex. 5 at 19:10-14.
8. `194 Patent — "one or more rules" (Claims 1, 2, 6, 15, 19, 20-22)
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction select a selected portion of No Construction "a defined set of said spectral-domain Necessary or, in the mathematical and logical representation based on alternative, "guidelines" steps that includes one or more rules relating comparing the relative to characteristics of magnitudes of up to the spectral lines in said three largest spectral peaks selected portion and one according to their amplitudes or more harmonics of and frequencies in order to spectral liens in said match the peaks to one of selected portion; and the idealized spectra shown by the plots 1600, 1610, 1620, 1630, or 1640 in Figs. 16A-C" Having rejected Philips' proposed construction for "classifying" terms, the court similarly rejects Philips' proposed construction for "one or more rules" and finds that "one or more rules" means "guidelines." As with "classifying," Philips' proposed construction would read limitations from the specification into the claim. The patentee expressly guides the patent away from a literal comparison to plots 1600, 1610, 1620, 1630, or 1640.9. `194 Patent — "spectral domain waveform/dataset/representation" (Claims 1, 3, 4, 5, 8, 10, 14, 15, 16, 17) spectral domain waveform; spectral domain waveform
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction transforming a time- No Construction "representation of the domain plethysmograph Necessary for "dataset," frequency components of a waveform into a "waveform," and signal that has been "representation" scrubbed by applying a identifying a plurality of motion artifact removal spectral peaks in said "Spectral domain" process to obtain a signal means "function of that that is ideally cleaner frequency" (e.g. has a better signal to noise ratio)" The parties have stipulated that the term "spectral" is defined as "frequency-related." Philips argues that the specification clearly states that the rule-based algorithm described in the `194 patent is designed to work only on a scrubbed signal. Consequently, Philips argues, the definition of these "spectral domain" related terms requires a "motion artifact removal" limitation. Philips directs the court's attention to two preferred embodiments described in the specification. Both preferred embodiments state that "the spectrum must be scrubbed. . . ." The Federal Circuit, however, has repeatedly warned that a "description of a preferred embodiment, in the absence of a clear intention to limit claim scope, is an insufficient basis on which to narrow the claims."For additional evidence of the patentee's clear intent to limit the claims, Philips points to the patent's description of figures 12 and 14A. Figure 12 "shows a block diagram of a signal processing system" and provides that "[i]deally, the waveform at terminal 1249 is cleaner (i.e. has a better signal to noise ratio) than the waveform at either scrubber input A or scrubber input B." Figure 14A "shows an ideal spectrum F(W) of a clean plethysmographic wave from a heart that is beating with every regular beat." These descriptions are insufficient to demonstrate the patentee's intent to limit the claims' scope. The court finds that Philips' proposed construction would improperly read the specification into the claims and, as a result, finds that no construction is necessary for "dataset," "waveform," and "representation."
D.I. 140, Ex. 5 at 16:30-32.
Id. at 17:20-22.
Laryngeal Mask Co. Ltd. v. Ambu, 618 F.3d 1367, 1372 (Fed. Cir. 2010) ("This sentence, which as its language indicates, describes what is shown in Figures 5 and 6, is not enough to require every backplate to include a tube joint. To be his own lexicographer, a patentee must use a `special definition of the term [that] is clearly stated in the patent specification or file history.'") (citing Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1580 (Fed. Cir. 1996)).
B. Analysis of Philips' Asserted Patents
10. `535 Patent — "selecting physiologically relevant first and second spectral values . . ." (Claim 1) selecting physiologically relevant first and second spectral values
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction "using criteria selected in "selecting first and second accordance with the spectral values that are by patient's physiological determined to have evaluating said first and parameters, making physiological relevance second spectral values adaptive selections from based on criteria selected in according to criteria among a plurality of accordance with selected in accordance complex combinatorial characteristics of the specific with the patient's values to assure that patient being monitored" physiological parameters; artifacts and noise are reduced or eliminated from the measurement quantities" Claim 1 if the `535 patent provides that the invention being claimed is a method of determining at least the concentration of a blood component from the intensity of electromagnetic waves with at least two selected wavelengths reflected by or transmitted through a patient's tissue. The method comprises of a number of steps including the selection of "physiologically relevant first and second spectral values by evaluating [those] spectral values according to criteria selected in accordance with the patient's physiological parameters." Claim 3, a dependent claim, replaces the quoted step with the forming of complex combinatorial values from the two spectral values and the selecting of combinatorial values according to criteria selected according to the patient's physiology. The presence of a dependent claim adding a particular limitation raises a presumption that the limitation in question is not found in the independent claim.To counter the claim dependency presumption, Masimo points to the prosecution history of the `535 patent where, in response to a prior art rejection by the Patent and Trademark Office ("patent office"), the applicants stated that "[a]ccording to a preferred embodiment . . . the signals are transformed into a frequency domain, using a Fourier transformation, so as to create complex combinatorial values." Masimo argues that this disclaimer is unequivocal and limits the patent scope to require complex combinatorial values.
D.I. 172, Ex. 16 at PHIL0321125.
The patent office rejected a number of the applicant's claims under 35 U.S.C. § 102(b) as anticipated by a previously issued patent. According to the examiner, "[t]he prior art teaches a variety of systems for optically determining concentration of components in tissue, but does not teach or suggest a method or apparatus that includes forming complex combinatorial values, selecting physiologically relevant combinatorial values, and calculating a concentration based on the selected combinatorial values, as set forth in the claims." The applicants countered that, while the prior art "discloses a blood oxygenation system [that] involves no selection activity from the derived complex measurement values . . . [a]pplicants make adaptive selections from among a plurality of complex values. . . ."
See D.I. 172, Ex. 16 at PHIL0321113.
Id.
Id. at PHIL0321126.
Regarding disclaimers in the prosecution history, the Federal Circuit has found that "the alleged disavowing actions or statements made during prosecution [must] be both clear and unmistakable." Here, the applicants' statement regarding "complex combinatorial values" arises in relation to a preferred embodiment. The disclaimer regarding "adaptive selections from among a plurality of complex values" arose to contrast the absence of "selection activity" in the prior art. As a result, the court cannot conclude that the statements constitute a clear and unmistakable surrender of claim scope and adopts Philips' proposed construction.
Omega Eng'g, Inc. v. Raytek Corp., 334 F.3d 1314, 1325-26 (Fed. Cir. 2003).
11. `535 Patent — "complex combinatorial values" (Claim 3, 6, 9, 10)Rk 2 IRk 2 Rk 2 IRk 2
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction forming complex "forming values with a "values formed from both combinatorial values magnitude component first and second spectral from said first and second equal to ( + () values" spectral values; and a phase component equal to ( / )" Philips concedes to Masimo's proposed construction regarding "complex combinatorial values." Therefore the court finds that "complex combinatorial values" means "forming values with a magnitude component equal to (Rk 2 + (IRk 2) and a phase component equal to (Rk 2 / IRk 2)."12. `535 Patent — "concentration" (Claims 1, 2, 3, 11, 12) concentration
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction A method of determining "the relative content of a No Construction Necessary at least the component dissolved in of a blood component from a known or measured In the alternative: "oxygen the intensity fo quantity of another saturation" or "the electromagnetic waves substance (such as percentage of hemoglobin with at least two selected blood or water) that may that is oxygenated" wavelengths which are be expressed in reflected by a patient's percentage by weight or tissue or transmitted by volume, in parts per through the patents tissue, million, or in grams per liter" Throughout the `535 patent, the patentees use the term "concentration" as analogous to gas saturation and oxygen saturation. The patent also defines oxygen saturation as a unitless ratio. Masimo does not point to any explicit language otherwise defining "concentration." Consequently, the court finds that "concentration" is defined as "oxygen saturation."13. `074 Patent — "uncertain logic" (Claim 1) uncertain logic
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction (b) interlinking the factors Indefinite "logic that is non-binary" by means of an including fuzzy logic, In the alternative: "Logic into a quality indicator that requires uncertainty wherein the quality in the reasoning indicator quantitatively process" describes a quality of a determined measurement value fo the measurement signal. The `074 patent deals with the generation of signal quality indicators through an "uncertain logic" analysis. The parties agree that "classical logic" requires that a proposition be represented in binary form as either a 1 (true) or 0 (false). Philips' argues that, in contrast to classical logic, "uncertain logic" allows for a more nuanced categorization, without requiring that each proposition be classified into one of two groups. By combining the analysis of a number of variables, the invention described in the patent generates, via a point system, a score between 0 and 100 regarding the accuracy of a physiological reading. In describing the invention, the patent repeatedly states that "uncertain logic" includes "fuzzy logic," which both parties agree is a type of non-binary logic. As a result, the court finds that the term "uncertain logic" is not "insolubly ambiguous [such that] no narrowing construction can properly be adopted." To the contrary, the court finds that by repeatedly describing "fuzzy logic" as a subset of "uncertain logic," the patent limits the definition of "uncertain logic" to "logic that is non-binary."14. `074 Patent — "fuzzy logic" (Claim 1) fuzzy logic,
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction (b) interlinking the factors 1. "A system that uses "logic that combines input by means of an uncertain inputs that are extracted values in a quantitative logic including from fuzzy sets manner to generate a non- into a quality indicator (fuzzification), a fuzzy binary result" wherein the quality reasoning process indicator quantitatively (inference), and outputs describes a quality of a that may be obtained by determined measurement defuzzification of fuzzy value fo the measurement set (defuzzification)." signal. 2. "Multivalued (as opposed to binary) logic developed to deal with imprecise or vague data. Classical logic holds that everything be expressed in binary terms: 0 or 1, black or white, yes or no; in terms of Boolean algebra, everything is in one set or another, but not in both. Fuzzy logic allows for partial membership in a set, values between 0 and 1, shades of gray and maybe; it introduces the concept of the `fuzzy set.'" During oral argument, the parties agreed to define "fuzzy logic" as "multivalued (as opposed to binary) logic developed to deal with imprecise or vague data. Fuzzy logic allows for partial membership in a set, values between 0 and 1, shades of gray and maybe; it introduces the concept of the `fuzzy set.'"15. `991 Patent — "reference signal having a fixed level" (Claims 1, 3) reference signal having a fixed level
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction (a) generating a "reference signal having "reference signal having a a fixed level" means: fixed level during an oxygen during an oxygen saturation monitoring saturation monitoring "permanently set voltage interval" means: interval; without using gain compensation (i.e. "a signal produced by a feedback control reference voltage that is not circuitry) of any sort" subject to variation over the entire period during which the oxygen saturation level is computed" The `991 patent is a continuation of U.S. Patent No. 5,190,038. Claim 1 of the `991 patent recites a "method of measuring oxygen saturation in the blood of a living person, comprising the steps of: (1) generating a reference signal having a fixed level during an oxygen saturation monitoring interval; (2) during said oxygen saturation monitoring interval, generating light having a first wavelength and light having a second wavelength. . . ." Although claim 1 provides for a fixed reference signal during an oxygen saturation monitoring interval, Masimo argues that during the prosecution of the `038 patent, the applicants limited the reference signal to a permanently fixed level.A "prosecution disclaimer may arise from disavowals made during the prosecution of ancestor patent applications," however the disclaimer must be a clear and unmistakable surrender of subject matter. To overcome prior art during the prosecution history of the `038 patent, the applicants noted that the pulse oximeter described in the prior art "requires feedback circuitry and a routine (646) which adjusts the LED intensities to correct `electrical values' when `data is over or undervalued electronically, i.e. beyond the voltage range of the circuitry,' thus clearly teaching away from the principles of the present invention." The applicants further stated that the claimed invention is "preprogrammed to (1) know the minimum and maximum, signal levels statistically possible (i.e. expected) at the light detectors, and (2) accommodate these expected minimum and maximum signal levels without using gain compensation (i.e. feedback control circuitry) of any sort." The court finds a clear disclaimer concerning the absence of "gain compensation (i.e. feedback control circuitry) of any sort" in relation to the invention's accommodation of the expected minimum and maximum signal levels. However, there is no similar clear and unmistakable disclaimer regarding the lack of gain compensation in other areas and with regard to the time period over which the reference signal is fixed. The disclaimers allow for a reasonable interpretation suggesting that the reference signal may be changed or modified when oxygen saturation is not being monitored, but gain compensation may not be used to modify the expected minimum and maximum signal levels.
Omega Eng'g, 334 F.3d at 1333 (Fed. Cir. 2003).
Cordis Corp. v. Medtronic Ave, Inc., 511 F.3d 1157, 1177 (Fed. Cir. 2008) ("[A]n applicant can make a binding disavowal of claim scope in the course of prosecuting the patent, through arguments made to distinguish prior art references. Such argument-based disavowals will be found, however, only if they constitute clear and unmistakable surrenders of subject matter.") (citations omitted); cf. SanDisk Corp. v. Memorex Prods., Inc., 415 F.3d 1278, 1287 (Fed. Cir. 2005) ("There is no `clear and unmistakable' disclaimer if a prosecution argument is subject to more than one reasonable interpretation, one of which is consistent with a proffered meaning of the disputed term.").
D.I. 166, Ex. 8 at MASP0021980.
Id. at MASP0021975.
Therefore, the court finds that "reference signal having a fixed level during an oxygen saturation monitoring interval" means "a signal produced by a reference voltage, without the use of gain compensation (i.e. feedback control circuitry) of any sort, that is not subject to variation over the entire period during which the oxygen saturation level is computed."
16. `991 Patent — "having a dynamic range . . ." (Claim 1)
having a dynamic range
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction "having an operational "having a dynamic range extending from at least range sufficient to sufficient to accommodate said expected minimum accommodate the the entire input signal signal magnitude to at minimum to the without compensation of any least said expected maximum signal levels kind extending from an maximum signal possible from a sensor expected minimum signal magnitude without compensation of magnitude to an expected any kind" maximum signal magnitude during an oxygen saturation monitoring interval" During oral argument, Philips conceded that "operational range" and "dynamic range" are essentially synonymous. The parties also agree to the claim language of "statistically possible (i.e. expected)" in place of "possible" and "expected."As a result of the court's construction of "reference signal having a fixed level during an oxygen saturation monitoring interval," and in light of the repeated assertions in claim 1 that the appropriate signals are generated only during the an oxygen saturation monitoring interval, the court finds that "having a dynamic range extending from at least said expected minimum signal magnitude to at least said expected maximum signal magnitude," is defined as "having an operational range sufficient to accommodate the entire signal without compensation of any kind extending from a statistically possible (i.e. expected) minimum signal magnitude to a statistically possible (i.e. expected) maximum signal magnitude during an oxygen saturation monitoring interval."
See Phillips, 415 F.3d at 1313 ("Importantly, the person of ordinary skill in the art is deemed to read the claim term not only in the context of the particular claim in which the disputed term appears, but in the context of the entire patent, including the specification.").
17. `991 Patent — "invalidating . . ." (Claim 7)
invalidating
Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction (e) a second "indicating as not being No Construction Necessary number of said output data valid" structures on the basis of one or more of said set of parameters, each said invalidated output data structure being precluded from use in the computation of oxygen saturation levels; During oral argument, Philips conceded to Masimo proposed construction. Therefore, the court finds that "invalidating" is defined as "indicating as not being valid."18. `991 Patent — "computer processing means . . ." (Claim 1)
Function: Function: Structure: Structure: SAT f mean mag * mag mean SAT f mean mag * mag max min mag mean mag max min mean max min mean max min
Disputed Claim Masimo's Proposed Construction Philips' Proposed Language Construction (f) processing computing the oxygen saturation computing said first and level of said blood during said oxygen the oxygen second digital saturation monitoring interval saturation level of signals in said blood during computer A central processing unit 100 said oxygen processing programmed to execute (1) a filter block saturation means so as to 270 to determine I(t), R(t), I'(t) and R'(t), monitoring interval compute the (2) a fixed threshold peak detector 310 to central oxygen saturation detect the peaks, both positive and processing unit 100 level of said blood negative, of the incoming waveform for programmed to during said each pulsation of blood flowing in the execute software oxygen saturation person being monitored, (3) a threshold including a monitoring detector 320 to determine whether the saturation processor interval. current values lie within the preset limits 360 utilizing a well and to alert a data validator 380 to identify established aberrant input data, and (4) Saturation calculation algorithm Processor 360 which calculated the to calculate the oxygen saturation level for each pulsation oxygen saturation not including invalid data using the level as follows: following function: OUT = ((I/I)(R/R)) OUT = Where: ((I/I) I = I'(t) — I'(t) (R/R)) R = R'(t) — R'(t) I = [I(t) + I(t)]/2 R = [R(t) + R(t)]/2 The parties agree this is a means-plus-function limitation governed by 35 U.S.C. § 112 ¶ 6 which recites:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material or acts described in the specification and equivalents thereof.
"Claim construction of a means-plus-function limitation includes two steps. First, the court must determine the claimed function. Second, the court must identify the corresponding structure in the written description of the patent that performs that function."
Applied Med. Res. Corp. v. U.S. Surgical Corp., 448 F.3d 1324, 1333 (Fed. Cir. 2006).
First, the parties agree that the function of the invention described in claim 1 is to "comput[e] the oxygen saturation level of [blood during the] oxygen saturation monitoring interval." The court will then consult the written description to determine the corresponding structure necessary to accomplish the stated function. The patent states that "[s]aturation processor 360 is the routine that actually calculates the oxygen saturation level . . . [t]he saturation processor utilizes a well established saturation calculation algorithm to calculate the oxygen saturation level . . . as follows: OUTSAT = f ((Imean/Imag)*(Rmag/Rmean))."
ACTV, Inc. v. Walt Disney Co., 346 F.3d 1082, 1087 (Fed. Cir. 2003).
D.I. 140, Ex. 11 at 10:38-50.
Masimo argues that according to Gemstar-TV Guide Int'l, Inc. v. Int'l Trade Com'n, all of the structure disclosed in the specification that is necessary to perform the claimed function forms part of the claim limitation. The Federal Circuit has found that where a means-plus-function claim involves software and computers, both the computer and the software are part of the corresponding structure. The `991 specification states that CPU 100 computes the oxygen saturation using "software systems [that] can accomplish the necessary calculations of the oxygen saturation level." The specification then describes "one example of appropriate software [in] the flow chart shown in FIG. 7." The referenced flow chart, according to Masimo, demonstrates that Filter Block 270, Threshold Peak Detector 310, Threshold Detector 32, Data Validator 280, and Saturation Processor 360 are required to calculate the claimed oxygen saturation level.
383 F.3d 1352 (Fed. Cir. 2004).
See Gemstar, 383 F.3d at 1361-63.
See WMS Gaming, Inc. v. Int'l Game Tech., 184 F.3d 1339, 1348-49 (Fed. Cir. 1999).
D.I. 140, Ex. 11 at 8:32-34.
Id. at 8:26-36.
In Asyst Tech., Inc. v. Empak, Inc., the Federal Circuit found that "[t]he corresponding structure to a function set forth in a means-plus-function limitation must actually perform the recited function, not merely enable the pertinent structure to operate as intended. . . ." In Asyst, the Federal Circuit was compelled by the language of a claim limitation which recited a "second microcomputer means for receiving and processing digital information communicated with said respective second two-way communication means." The court determined the function of the limitation to be receiving and processing digital information from a second two-way communication means. Although the court acknowledged that a component, a communication line, enabled the second microcomputer means to perform the function, in the sense that digital information would not reach the microcomputer means without a communication line, the court found that the communication line did not actually perform either of the recited functions. Similarly, in the case sub judice, Masimo concedes that Filter Block 270, Threshold Peak Detector 310, Threshold Detector 32, and Data Validator 280 do not conduct the calculation described; they provide the appropriate signals to Signal Processor 360. Unlike Gemstar, in which the disputed component was "integral to performing the claimed function of the `means . . . for displaying the television schedule' limitation," the additional components here do not "comput[e] the oxygen saturation level of [blood during the] oxygen saturation monitoring interval." Rather, as in Asyst, the components Masimo proposes be included merely enable Signal Processor 360 to perform the claimed function. As a result, the court finds that the structure of a "computer processing means" is defined as "central processing unit 100 programmed to execute software including a saturation processor 360 utilizing a well established calculation algorithm to calculate the oxygen saturation level as follows:SAT f mean mag * mag mean mag max min mag max min mean max min mean max min
268 F.3d 1364, 1371 (Fed. Cir. 2001).
Asyst, 268 F.3d at 1371.
Id.
Id.
Id. at 1371.
D.I. 184 at 467.
Gemstar, 383 F.3d at 1363.
19. `991 Patent — "signal conversion means . . ." (Claim 1)
"signal conversion Function: Function: means Structure: signal conversion means Structure: Disputed Claim Language Masimo's Proposed Philips' Proposed Construction Construction converting the converting said having a dynamic first analog electrical first electrical signal into a range extending from at signal into a first digital first digital signal and said least said expected signal and converting a second electrical signal into minimum signal magnitude second, separate analog a second digital signal to at least said expected electrical signal into a maximum signal second digital signal A/D converters magnitude so that said 90, 95 two at least accommodates said first 20-bit analog to digital and second electrical converters 90 and 95 signal and converts said each having an first electrical signal into a operational range first digital signal and said sufficient to second electrical signal accommodate the into a second digital minimum to the signal" maximum signal levels possible from a sensor without compensation of any kind The parties agree this is a means-plus-function limitation governed by 35 U.S.C. § 112 ¶ 6. Regarding the function of the "signal conversion means" claim, Philips stated no objection to replacing "first electrical signal" with "first analog electrical signal." Masimo, in turn, stated no objection to replacing "separate" with "distinct," as implied in Philips' responsive brief. As a result, the court finds that the function of the "signal conversion means" claim is "converting the first analog electrical signal into a first digital signal and converting a second, distinct analog electrical signal into a second digital signal."Pertaining to the structure of the claim, Masimo agreed at oral argument to remove all language following "digital converters 90 and 95" from the claim. The parties continue to dispute the inclusion of the "at least 20-bit" limitation. In Fig. 1 of the specification, the patentees state that both ADC 90 and ADC 95 are "20-bit" converters. Later, the specification again refers to "the 20 bit analog to digital converters 90 and 95." The specification, for a third time, states that "[t]he use of at least a 20 bit analog to digital converter is preferred in order to achieve the advantages possible with the instant invention." A "structure disclosed in the specification is `corresponding' structure only if the specification or prosecution history clearly links or associates that structure to the function recited in the claim." "A specification that merely mentions the possibility of alternative structures without specifically identifying them is not sufficient to expand the scope of the claim beyond the single example used." Here, the limitation outlined in the single structure disclosed by Fig. 1 and the specification cannot be expanded by the statement that at least a 20 bit converter is preferred.
D.I. 184 at 484.
D.I. 140, Ex. 11 at Fig. 1.
Id. at 7:67-8:2 ("Low pass filters 70 and 75 function essentially as noise filters in that the 20 bit analog to digital converters 90 and 95 can, under some conditions, be sensitive to noise.").
Id. at 8:4-7.
B. Braun Med., Inc. v. Abbott Labs., 124 F.3d 1419, 1424 (Fed. Cir. 1997).
Faroudja Labs., Inc. v. Dwin Electronics, Inc., 76 F. Supp. 2d 999, 1003, 1011-12 (N.D. Cal. 1999) (rejecting argument that general description of structure in the patent superseded more specific examples provided in the patent's illustrations, because specification did not provide alternative structures and disclosed the particular structure as the only embodiment) (citing Fonar Corp. v. General Electric Co., 107 F.3d 1543, 1551 (Fed. Cir. 1997), cert. denied, 522 U.S. 908 (1997)); Continental Lab. Products, Inc. v. Medax Int'l, Inc., 1999 WL 33116499, *14 (S.D. Cal. Aug. 12, 1999) ("[W]hen the preferred embodiment is the only corresponding structure disclosed in the specification, the court will limit the means plus function element to cover the preferred embodiment and its `equivalents thereof.'").
Philips points to subsequent language stating that the converters are specifically designed to handle a broad range of input signals. Again, the specification only mentions the possibility of alternative structures; it does not specifically identify them. For the same reasons as the "preferred" statement, this language cannot broaden the scope of the claim. Consequently, the court finds that the structure of the "signal conversion means claim" is defined as "two at least 20-bit analog to digital converters 90 and 95."
D.I. 140, Ex. 11 at 8:7-19 (stating that the converters are "specifically designed to have a broad dynamic range, sufficient to accommodate the entire input signal from sensor 10 without compensation of any kind . . . [and that the utilization] is specifically designed knowing the minimum and maximum signal levels possible from sensor 10 and to accommodate those minimum and maximum levels.").
III. ORDER AND RECOMMENDED DISPOSITION
At Wilmington, this 18th day of February, 2011, having reviewed the papers submitted with the parties' proposed claim constructions, heard oral argument, and having considered all of the parties arguments (whether or not those arguments were explicitly discussed supra);
IT IS ORDERED, ADJUDGED, and DECREED that the disputed claim language in asserted claims of the patents-in-suit, as identified by the parties, shall be construed consistent with the tenets of claim construction set forth by the United States Court of Appeals for the Federal Circuit in Phillips v. AWH Corp. as follows: "signal processor" "signal model" "comparing" "determining" "calculation technique" "center of mass" "classifying" "one or more rules" "spectral domain waveform," "spectral domain dataset," and "spectral domain representation" "selecting physiologically relevant first and second spectral values . . ." "complex combinatorial values" Rk 2 IRk 2 Rk 2 IRk 2 "concentration" "uncertain logic" "fuzzy logic" "reference signal having a fixed level" "having a dynamic range" "invalidating" "computer processing means" Function: Structure: SAT f mean mag * mag mean mag max min mag max min mean max min mean max min "signal conversion means" Function: Structure:
Disputed Claim Term Construction of the Court "a processing unit which determines either a secondary reference n'(t) or a primary reference s'(t) for use in a correlation canceler, such as an adaptive noise canceler" "the relationship between two physiological signals which follows certain conditions" "calculating point-by-point comparisons of the first and second transformed signals" "calculating point-by-point comparisons of the first and second transformed signals" No Construction Necessary No Construction Necessary No Construction Necessary "guidelines" No Construction Necessary for "waveform," "dataset," and "representation" "spectral domain" means "frequency- related" "selecting first and second spectral values that are determined to have physiological relevance based on criteria selected in accordance with characteristics of the specific patient being monitored" "forming values with a magnitude component equal to ( + ) and a phase component equal to ( / )" "oxygen saturation" "logic that is non-binary" "multivalued (as opposed to binary) logic developed to deal with imprecise or vague data. Fuzzy logic allows for partial membership in a set, values between 0 and 1, shades of gray and maybe; it introduces the concept of the `fuzzy set'" "a signal produced by a reference voltage, without the use of gain compensation (i.e. feedback control circuitry) of any sort, that is not subject to variation over the entire period during which the oxygen saturation level is computed" "having an operation range sufficient to accommodate the entire signal without compensation of any kind extending from a statistically possible (i.e. expected) minimum signal magnitude to a statistically possible (i.e. expected) maximum signal magnitude during an oxygen saturation monitoring interval" "indicating as not being valid" computing the oxygen saturation level of said blood during said oxygen saturation monitoring interval central processing unit 100 programmed to execute software including a saturation processor 360 utilizing a well established calculation algorithm to calculate the oxygen saturation level as follows: OUT = ((I/I)(R/R)) Where: I = I'(t) — I'(t) R = R'(t) — R'(t) I = [I(t) + I(t)]/2 R = [R(t) + R(t)]/2 converting the first analog electrical signal into a first digital signal and converting a second distinct analog electrical signal into a second digital signal "two at least 20-bit analog to digital converters 90 and 95" This Report and Recommendation is filed pursuant to 28 U.S.C. § 636(b)(1)(B), Fed.R.Civ.P. 72(b)(1), and D.Del.LR 72.1. The parties may serve and file specific written objections within fourteen (14) days after being served with a copy of this Report and Recommendation. The objections and response to those objections are limited to ten (10) pages each.The parties are directed to the court's standing Order in Pro Se Matters for Objections Filed under Fed.R.Civ.P. 72, dated November 16, 2009, a copy of which is available on the court's website, www.ded.uscourts.gov.
Dated: 2/18/2011