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Masimo Corporation v. Philips Electronics North America Corporation

United States District Court, Third Circuit

August 29, 2013

MASIMO CORPORATION, Plaintiff,
v.
PHILIPS ELECTRONICS NORTH AMERICA CORPORATION and PHILIPS MEDIZIN SYSTEME BÖBLINGEN: GmbH, Defendants.

REPORT AND RECOMMENDATION

MARY PAT THYNGE, Magistrate Judge.

I. INTRODUCTION

This is a patent infringement case. Plaintiff Masimo Corporation ("Masimo") and defendants Philips Electronics North American Corporation and Philips Medizin Systeme Böblingen GMBH (collectively, "Philips") manufacture competing products in the field of pulse oximetry. Pulse oximetry allows for non-invasive measurement of the oxygen levels in a medical patient's hemoglobin.

Generally, pulse oximetry operates via a sensor placed over a thin section of a patient's body, such as the fingertip or earlobe of an adult, or the foot of an infant. The sensor emits red and infrared light through a cross-section of the patient's tissue and measures the amount of light absorbed. Using various algorithms, a monitor then processes the signal and calculates the patient's oxygenation level. Pulse oximetry systems are standard equipment in many clinical settings, either as stand-alone devices, or more commonly, as components of integrated multi-parameter patient monitors which track pulse, temperature, and other physiological vital signs.

II. CLAIMS-AT-ISSUE

This litigation involves seven patents asserted by Masimo and one patent asserted by Philips.[1]

III. CLAIM CONSTRUCTION

"The words of a claim are generally given their ordinary and customary meaning as understood by a person of ordinary skill in the art when read in the context of the specification and prosecution history."[2] The Federal Circuit has stated "[t]here are only two exceptions to this general rule: 1) when a patentee sets out a definition and acts as his own lexicographer, or 2) when the patentee disavows the full scope of a claim term either in the specification or during prosecution."[3]

"To act as its own lexicographer, a patentee must clearly set forth a definition of the disputed claim term' other than its plain and ordinary meaning."[4] "It is not enough for a patentee to simply disclose a single embodiment or use a word in the same manner in all embodiments, the patentee must clearly express an intent' to redefine the term."[5]

The standard for disavowal of claim scope is similarly exacting. "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." SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1341 (Fed. Cir. 2001). "The patentee may demonstrate intent to deviate from the ordinary and accustomed meaning of a claim term by including in the specification expressions of manifest exclusion or restriction, representing a clear disavowal of claim scope." Teleflex, Inc. v. Ficosa N. Am. Corp., 299 F.3d 1313, 1325 (Fed. Cir. 2002).[6]

As with its explanation of a patentee acting as its own lexicographer, the Federal Circuit stated "Mt is likewise not enough that the only embodiments, or all of the embodiments contain a particular limitation."[7] The court concluded: "[w]e do not read limitations from the specification into claims; we do not redefine words. Only the patentee can do that. To constitute disclaimer, there must be a clear and unmistakable disclaimer."[8]

A. Disputed Claim Terms in Masimo's Patents

1. scan of a plurality of possible values for said physiological parameter (850 patent, claim 45)

Masimo's proposed construction is: "examination of more than one possible value for the physiological parameter."

Philips' proposed construction is: "examination of each of the plurality of possible values for the physiological parameter."

Claim 45 of the '850 patent recites:

A method of improving the determination of a physiological parameter based upon physiological signals, said method comprising the steps of:
sensing a physiological signal indicative of the physiological parameter, said physiological parameter having a predetermined range of possible values;
in response to said physiological signal, determining a plurality of possible indications of said physiological parameter based on a scan of a plurality of possible values for said physiological parameter within said predetermined range of possible values for said physiological parameter; and
analyzing said plurality of possible indications to determine a resulting indication that likely most closely correlates to the physiological parameter.[9]

The dispute between the parties' is whether the claim requires examining more than one possible value of the recited physiological parameter or each of the possible values for the physiological parameter. The ordinary meaning of plurality is "more than one."[10] Masimo contends there was no disavowal of claim scope during prosecution, no clearly set forth definition altering the ordinary meaning, and that the specification never suggests that "each of the plurality of possible values" must be scanned. Philips argues the intrinsic record demonstrates the phrase "scan of a plurality of possible values" is a detailed examination of each of the plurality of possible values of the predetermined range of possible values of the physiological parameter.

Masimo maintains the specification describes embodiments that do not require a scan of each of the plurality of possible values. The saturation transform embodiment discloses "doing a scan of many possible coefficients."[11] Masimo states that embodiment could also execute a scan "for a good cross-section of possible values ra and rv (e.g., 20-50 values each corresponding to saturation values ranging from 30-105)."[12] It also argues the "Bank of Filters" embodiment, described as an alternative to the saturation transform embodiment, [13] involves only scanning some possible values and does not require a scan of each of the plurality of possible values."[14] Finally, Masimo contends the Complex FFT embodiment, described as another alternative to the saturation transform embodiment, [15] also scans only some possible values.[16]

Philips states Masimo's arguments focus on one portion of the disputed phrase in isolation, "a plurality of possible values, " and ignore the remainder of the claim language including the leading word "scan." Philips states "scan" is a common word but its meaning is dependent upon the context in which it is used.[17] It contends the '850 patent explicitly states "a scan of a plurality of possible values" is a detailed examination of each of the plurality of possible values. According to Philips, in each instance the specification uses the word "scan, " it is discussed in conjunction with the algorithm executed by the "Saturation Transform" module, illustrated in Figure 18.[18] Philips discusses the description of that module and that "a master power curve" is generated where "the spectral content of the attenuated energy is examined by looking at every possible saturation value and examining the output value for the assumed saturation value."[19] According to Philips, the specification repeatedly emphasizes that a reference signal is generated for each of the predetermined values in the range:

"In other words, the reference processor is provided with each of the saturation values, and a resultant reference signal is generated corresponding to the saturation value."[20]
"This operation is completed for each of the saturation scan values (e.g., 117 possible values in the present embodiment)."[21]
"The resulting data at a second output 540 of the bandpass filter 538, therefore, is 117 reference signal vectors of 270 data points each, corresponding to each of the saturation axis values ...."[22]

Philips contends one of ordinary skill in the art reading the '850 patent would understand the claimed "scan of a plurality of possible values" is the examination of each of the provided saturation scan values.[23] Since no other "scan" is described in the '850 patent, Masimo's proposed construction is contrary to what is disclosed and illustrated in the specification. Applying Masimo's proposed construction to the embodiment disclosed in column 43 of the patent would only require the examination of 2 of the 117 saturation scan values that constitute the predetermined range of values, a result, Philips argues, that is purportedly contrary to the explicit disclosure of the '850 patent. Philips also states Masimo's construction is at odds with the rest of claim 45.[24] It points to the following part of claim 45:

sensing a physiological signal indicative of the physiological parameter, said physiological parameter having a predetermined range of possible values;
in response to said physiological signal, determining a plurality of possible indications of said physiological parameter based on a scan of a plurality of possible values for said physiological parameter within said predetermined range of possible values for said physiological parameter. [25]

Philips states Masimo's construction would encompass a scan of any two or more possible values. Philips contends, however, the surrounding claim language makes explicit what values must be examined-the values that are within the predetermined range of possible values. It concludes, once a range of potential values is determined (e.g., the 117 possible values contemplated in the preferred embodiment), the claim requires a scan of each value within that range. Contrary to Masimo's contention, Philips states its construction would not require examination of an infinite number of values. In response to Masimo's citation that the patent discloses examining crosssectional samples of possible values, Philips maintains the patent identifies that series of cross-sectional samples as a "saturation axis scan": "In addition, a plurality of possible saturation values (the saturation axis scan') are provided as input to the saturation reference processor 530."[26] Philips states those lines specifically recite a "plurality of possible saturation values" are provided as an input to reference processor 530. The "plurality of possible values" is a known quantity of values that establishes a predetermined range; it is not infinite or otherwise unclear. Philips notes in the preferred embodiment, 117 values are used as the predetermined range, but the specification recognizes that a different number than 117 could be chosen, such that there could be greater or fewer values; in each instance, there would be a finite and known number of values. Philips reiterates it is not suggesting the claim requires examination of every one of the infinite values between two endpoints, rather, its construction requires that once a predetermined range is established, the "scan" must examine each one of the plurality of possible values within that predetermined range.

Philips also contends the "Bank of Filters" and "Complex FFT" embodiments are not relevant as they have nothing to do with the meaning of the phrase "scan of a plurality of possible values, " and nowhere in the description of those alternate embodiments does the patent refer to either as a "scan"; each are described as "Alternative to Saturation Transform." In contrast, the Saturation Transform module is consistently referred to as a "scan." Philips further points out the Bank of Filters embodiment includes the histogram of Figure 24, which is described as "similar" to the saturation scan output of Figure 22.[27] Also, Figure 22 is captioned "Saturation Scan Values, " while the title of Figure 24 is simply "Saturation Values." Philips, concludes the specification, therefore, is clear that the Bank of Filters and Complex FFT embodiments are alternatives to the scan embodiment recited in claim 45, not further examples of a scan.

The court agrees with Philips that claim 45 of the '850 patent is directed at the saturation transform embodiment, and not the alternative embodiments discussed in the specification. Claim 45 recites "a scan of a plurality of possible values for said physiological parameter...." A "scan" is only discussed in conjunction with the saturation transform embodiment and, as noted above, the specification makes clear that each of the saturation values is examined. Philips' proposed construction does not improperly import limitations from preferred embodiments. Its construction merely requires that, regardless of the number of possible values of the physiological parameter, each is examined.[28] Consequently, the court construes "scan of a plurality of possible values for said physiological parameter" to mean: "examination of each of the plurality of possible values for the physiological parameter."

2. said scan (850 patent, claim 25)

Masimo's proposed construction is: "the analysis to qualify the plurality of indication values to be considered as possible resulting indications for the physiological parameter."

Philips contends this phrase is indefinite under 35 U.S.C. § 112.
Claim 25 of the '850 patent recites:
A physiological monitor which receives physiological signals indicative of at least one physiological parameter, said physiological parameter having a predetermined range of possible values, comprising:
a physiological indication calculation module which responds to said physiological signals to determine a plurality of possible physiological indication values based upon alternative determination methods;
an analysis module responsive to said plurality of indication values to qualify said plurality of indication values to be considered as a possible resulting indications for said physiological parameter; and
a selection module responsive to the result of said scan to identify at least one resulting indication as representative of said physiological parameter.[29]

Philips argues claim 25 patent is invalid for indefiniteness, pursuant to 35 U.S.C. § 112, ¶ 2, due to a lack of antecedent basis for "said scan" and that the metes and bounds of the claim are indeterminate even after considering all of the intrinsic evidence.[30]

[T]he failure to provide explicit antecedent basis for terms does not always render a claim indefinite.'"[31] When the meaning of the claim would reasonably be understood by persons of ordinary skill when read in light of the specification, the claim is not subject to invalidity upon departure from the protocol of antecedent basis."[32] In order for the claim to be found indefinite, Philips must "demonstrate by clear and convincing evidence that one of ordinary skill in the relevant art could not discern the boundaries of the claim based on the claim language, the specification, the prosecution history, and the knowledge in the relevant art.'"[33] "By finding claims indefinite only if reasonable efforts at claim construction prove futile, [courts] accord respect to the statutory presumption of patent validity... and... protect the inventive contribution of patentees, even when the drafting of their patents has been less than ideal.'"[34]

During prosecution, application claim 66 (which issued as claim 25), was amended as follows:

66. A physiological monitor which receives physiological signals indicative of at least one physiological parameter, said physiological parameter having a predetermined range of possible values, comprising:
a physiological indication calculation module which responds to said physiological signals to determine [calculate] a plurality of possible physiological indication values based upon alternative determination methods;
[a scan] an analysis module responsive to said plurality of indication values to [scan] qualify said plurality of indication values to be considered as a possible resulting indications for said physiological parameter [within a range of said predetermined possible values]; and
a selection module responsive to the result of said scan to [select] identify at least one resulting indication [value] as representative of said physiological parameter.[35]

Philips states that originally the claim required the performance of a "scan" similar to the scan recited in claim 45. The claim recited "a scan module responsive to said plurality of indication values to scan said plurality of indication values within a range of said predetermined possible values." The amendment replaced the "scan" module with an "analysis" module that qualifies values calculated by "alternative determination methods." According to Philips, the patentee removed the "scan" of values "within a range of said predetermined possible values" and replaced it with something else (a "qualification"), making it unclear to one of ordinary skill in the art whether "said scan" is the scan explicitly disclosed in the specification or something completely different. Philips concludes, therefore, the phrase "said scan" renders claim 25 indefinite because the phrase is ambiguous.

Masimo notes that at the time of the examiner's rejection, the third paragraph of the claim recited "a scan module... to scan said plurality of indication values..." and the last paragraph recited "a selection module responsive to the result of said scan." Masimo states the phrase "said scan" was referring to the result of the scan module. When amended, the claim renamed the "scan module" to be "an analysis module." Masimo argues, therefore, "said scan" was still referring to the result from this same module, even though the name of the module was amended. Masimo concludes, therefore, that one of skill in the art would understand that "said scan" refers to "the analysis to qualify the plurality of indication values to be considered as possible resulting indications for the physiological parameter."

The court determines Philips has not established by clear and convincing evidence that "said scan" is insolubly ambiguous. Examination of the prosecution history supports Masimo's position that "said scan" refers to the result of the "analysis module." Consequently, the court construes "said scan" to mean: "the analysis to qualify the plurality of indication values to be considered as possible resulting indications for the physiological parameter."

3. analysis to determine which of the plurality of possible oxygen saturation values corresponds to the oxygen saturation of the pulsing blood (154 patent, claim 9)

Masimo's proposed construction is: "analysis to determine an oxygen saturation value that corresponds to oxygen saturation of the pulsing blood."

Philips' proposed construction is: "determination of a resulting oxygen saturation value based on the likelihood that it is the closest of the possible oxygen saturation values to the actual oxygen saturation of the pulsing blood."

Claim 9 of the '154 patent recites:

A pulse oximeter comprising:
an input for receiving from a detector information about light of first and second wavelengths attenuated by body tissue carrying pulsing blood over a period of time;
a processor configured to perform a method comprising:
transforming first and second signals into the frequency domain, wherein the first and second signals are representative of the light of first and second wavelengths attenuated by body tissue carrying pulsing blood;
calculating a plurality of possible oxygen saturation values using a plurality of values of each of the transformed first and second signals that correspond to non-zero frequencies; and
selecting one of the plurality of possible oxygen saturation values as an oxygen saturation measurement based upon an analysis to determine which of the plurality of possible oxygen saturation values corresponds to the oxygen saturation of the pulsing blood; and
an output for outputting the oxygen saturation measurement.[36]

Masimo contends the intrinsic record supports applying the ordinary meaning of this phrase as reflected in its proposed construction. It argues Philips attempts to improperly narrow the invention by construing the relatively broad word "corresponds" to mean "based on the likelihood that it is the closest of the possible oxygen saturation values." Masimo maintains there is no support for such an interpretation because the specification discloses multiple ways to determine a resulting oxygen saturation from a plurality of possible oxygen saturation values. For instance, Masimo contends the Bank of Filters and Complex FFT embodiments described in the '154 patent select values that correspond to arterial saturation, without knowing which one is closest to the actual value.[37] It states each of those embodiments: (1) transforms red and infrared signals into the frequency domain, and then uses the frequency-domain signals to calculate saturation values at a plurality of frequency ranges;[38] (2) determines a resulting saturation value using the plurality of saturation values that were calculated at different frequency ranges;[39] and (3) discloses two different ways of analyzing the values, based on a histogram, to select "one of the plurality of possible oxygen saturation values as an oxygen saturation measurement" as recited in claim 9.[40]

Referencing Figure 24, Masimo states some points on the histogram correspond to arterial saturation and others correspond to venous saturation.[41] Therefore, multiple values in the histogram correspond to arterial saturation, and multiple values correspond to venous saturation. Further, the patent provides different ways of selecting values that correspond to arterial saturation. For instance, one embodiment selects the highest histogram peak corresponding to the higher saturation values: "the arterial saturation can be calculated from the histogram by selecting the peak (greatest number of occurrences in the area of interest) corresponding to the highest saturation value...", [42] "a histogram similar to the histogram of FIG. 22 can be generated in which the number of saturation values at different frequencies (points) are summed to form a histogram of the number of occurrences for each particular saturation value."[43] Another embodiment simply selects the value corresponding to the highest saturation value: "as an alternative to the histogram, the output saturation (not necessarily a peak in the histogram) corresponding to the highest saturation value could be selected as the arterial saturation with the corresponding ratio representing ra";[44] "the arterial saturation value can be selected simply as the point corresponding to the largest saturation value for all points output from the saturation equation module 672 for a packet."[45] Masimo argues both ways determine an oxygen saturation value that "corresponds" to the oxygen saturation of the pulsing blood, as recited by the claim. Where arterial oxygen saturation is desired, the values corresponding to venous saturation are not selected and, because the peak and highest saturation value both correspond to arterial saturation, the patent explains either value would provide a result that could be displayed: "[i]n either method, the arterial saturation can be obtained and provided as an output...."[46] Masimo explains that, although similar, Figure 24 illustrates that the two results are different values for saturation. It contends neither analysis involves a determination based on which value is the "closest" to the actual value and that the specification does not disclose attempting to choose between them to select the "closest."

Philips states the disputed phrase refers to the selection of a single value by performing an "analysis" of many possible calculated values. It criticizes Masimo's contention that the selected value need not be the closest value as illogical, as it would be undesirable to select a value that is not the best representative-or closest to-the actual value. It also states Masimo's construction attempts to read out the requirement that the selected value is one of the previously calculated "plurality of possible oxygen saturation values" based on that construction changing the recitation of "determi[ing] which of the plurality of possible oxygen saturation values corresponds to the oxygen saturation" to "determin[ing] an oxygen saturation value that corresponds to the oxygen saturation." Philips maintains the claim requires calculating a plurality of possible oxygen saturation values, and then determining which one of those values is the resulting oxygen saturation value but, under Masimo's construction, a new value could be determined.

Masimo reiterates the specification does not discuss selecting a single best value. Masimo acknowledges Philips contention that its construction does not, in and of itself, require "the selected value be one of the values calculated in the prior claim step, " but notes other limitations of the claim require the selected value be one of the previously calculated values. Because claim 9 recites "selecting one of the plurality of possible oxygen values as an oxygen saturation measurement, " Masimo contends its construction does not remove that limitation from the claim.

The court adopts Masimo's proposed construction. First, the court agrees Masimo's construction does not remove the requirement that the selected value be one of the values calculated in the prior claim step due to the limitation Masimo cites. Second, the specification does describe an embodiment that selects the highest histogram peak corresponding to the highest saturation value, arguably the value that is "closest" to the actual oxygen saturation, as Philips' proposed construction requires. However, the specification also discloses an embodiment that selects the value corresponding to merely the highest saturation value, i.e. not necessarily a peak, thus demonstrating that Philips' proposed construction is unduly narrow. Consequently, the court construes "analysis to determine which of the plurality of possible oxygen saturation values corresponds to the oxygen saturation of the pulsing blood" to mean: "analysis to determine an oxygen saturation value that corresponds to oxygen saturation of the pulsing blood."

4. calculating a plurality of ratios of values of the transformed first signal to corresponding values of the transformed second signal (154 patent, claim 12)

Masimo's proposed construction is: "calculating more than one ratio of values of the transformed first signal and the transformed second signal on a frequency-consistent, or a point-by-point, basis."

Philips' proposed construction is: "calculating point-by-point ratios of the transformed ...


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