UNITED STATES INTERNATIONAL TRADE COMMISSION
`WASHINGTON, D.C.
`
`Before the Honorable Monica Bhattacharyya
`Administrative Law Judge
`
`In the Matter of
`
`CERTAIN LIGHT-BASED PHYSIOLOGICAL
`MEASUREMENT DEVICES AND
`COMPONENTS THEREOF
`
`
`
`
`
`
`Inv. No. 337-TA-1276
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`COMPLAINANTS’ OPENING CLAIM CONSTRUCTION BRIEF
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`1
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`APPLE 1022
`Apple v. Masimo
`IPR2022-01300
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`TABLE OF CONTENTS
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`Page No.
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`I.
`
`II.
`
`INTRODUCTION ....................................................................................................... 1
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`BACKGROUND OF THE ASSERTED PATENTS ................................................... 2
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`A.
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`B.
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`Pulse Oximetry Overview ................................................................................ 2
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`The Asserted Patents ........................................................................................ 7
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`1.
`
`2.
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`3.
`
`The ’501, ’502, and ’648 Patents ......................................................... 7
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`The ’745 Patent .................................................................................... 9
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`The ’127 Patent .................................................................................. 10
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`III.
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`LEGAL STANDARDS ............................................................................................. 11
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`A.
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`B.
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`Claim Construction ........................................................................................ 11
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`Indefiniteness ................................................................................................. 13
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`IV.
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`PERSON OF ORDINARY SKILL IN THE ART ..................................................... 13
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`V.
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`ARGUMENT ............................................................................................................. 14
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`A.
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`Bulk Measurement ......................................................................................... 14
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`1.
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`2.
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`3.
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`The Intrinsic Evidence Supports Masimo’s Construction ................. 15
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`Extrinsic Evidence Supports Masimo’s Construction ....................... 18
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`“Bulk Measurement” Is Not Indefinite .............................................. 19
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`B.
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`C.
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`Second Shape ................................................................................................. 21
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`Plurality of Operating Wavelengths ............................................................... 24
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`VI. CONCLUSION .......................................................................................................... 27
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`TABLE OF AUTHORITIES
`
`Page No(s).
`
`Advanced Cardiovascular Sys. v. Medtronic, Inc.,
`265 F.3d 1294 (Fed. Cir. 2001)........................................................................................ 11
`
`Akzo Nobel Coatings, Inc. v. Dow Chem. Co.,
`811 F.3d 1334 (Fed. Cir. 2016)........................................................................................ 13
`
`BASF Corp. v. Johnson Matthey Inc.,
`875 F.3d 1360 (Fed. Cir. 2017).................................................................................. 13, 19
`
`Biosig Instruments, Inc. v. Nautilus, Inc.,
`783 F.3d 1374 (Fed. Cir. 2015)........................................................................................ 13
`
`Indacon v. Facebook,
`824 F.3d 1352 (Fed. Cir. 2016)........................................................................................ 12
`
`Markman v. Westview Instruments, Inc.,
`517 U.S. 370 (1996) ................................................................................................... 13, 19
`
`Nautilus, Inc. v. Biosig Instruments, Inc.,
`572 U.S. 898 (2014) ......................................................................................................... 13
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) ............................................................ 11, 12, 20
`
`Terlep v. Brinkmann Corp.,
`418 F.3d 1379 (Fed. Cir. 2005)........................................................................................ 11
`
`Teva Pharms. USA, Inc. v. Sandoz, Inc.,
`135 S. Ct 831 (2015) ........................................................................................................ 11
`
`Vitrionics Corp. v. Conceptronic, Inc.,
`90 F.3d 1576 (Fed. Cir. 1996).................................................................................... 11, 12
`
`Ground Rule 6.1 ..................................................................................................................... 19
`
`OTHER AUTHORITIES
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`-ii-
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`I. INTRODUCTION
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`Complainants Masimo Corporation and Cercacor Laboratories, Inc. (collectively,
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`“Masimo”) submit this opening claim construction brief regarding three disputed claim phrases
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`from five asserted patents: U.S. Patent Nos. 10,912,501 (“the ’501 patent”), 10,912,502 (“the ’502
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`patent), 10,945,648 (“the ’648 patent”), 10,687,745 (“the ’745 patent”), and 7,761,127 (“the ’127
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`patent”) (collectively, “the asserted patents”).
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`The asserted patents contain simple language readily understood by a skilled artisan.
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`Across the five patents and numerous asserted claims, only three claim phrases are presented for
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`construction: (1) “bulk measurement”; (2) “second shape”; and (3) “plurality of wavelengths.”
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`Masimo’s proposed constructions for these phrases are supported by the intrinsic evidence,
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`including the claims, the specifications, and the relevant prosecution history.
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`The first phrase for construction is “bulk measurement.” A skilled artisan would readily
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`understand “bulk measurement” to refer to a baseline measurement. That baseline is simply the
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`non-pulsatile or DC component of the measurement or signal and forms the vast majority of the
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`signal. The specification repeatedly and consistently contrasts a “bulk measurement” with the
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`pulsatile measurement, which forms a very small component of the signal. Apple’s expert
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`obfuscates the basic distinction between the bulk and the pulsatile measurement to inject ambiguity
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`where none exists. Apple cannot meet its burden of showing this well-understood phrase is
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`indefinite.
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`The second phrase for construction is “second shape.” During prosecution of a parent
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`patent application, Masimo explained the meaning of this phrase through an amendment and
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`remarks in response to cited prior art. Masimo’s proposed construction is based on that prosecution
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`confirming that “second shape” is a shape that is different from the first shape beyond a change in
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`size of the first shape. Apple’s proposed construction ignores this explanation.
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`The third phrase for construction is “plurality of operating wavelengths.” Masimo’s
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`proposed construction “operating wavelength that varies with temperature” takes into account the
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`specification’s teaching that each of the recited LEDs has a wavelength that varies with
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`temperature. Apple’s proposed construction simply defines “plurality” as two or more, a point
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`that is not in debate. Masimo does not know the basis for Apple’s disagreement.
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`Masimo supports its positions with expert reports submitted by Vijay K. Madisetti, Ph.D.
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`and Jack Goldberg (Exs. 1-3). As described in detail below, the ALJ should adopt Masimo’s
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`proposed constructions.
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`II. BACKGROUND OF THE ASSERTED PATENTS
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`A.
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`Pulse Oximetry Overview
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`Masimo is a global medical technology company that, through years of innovation, has
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`revolutionized non-invasive monitoring of physiological parameters, such as pulse rate, arterial
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`oxygen saturation and many others. In particular, Masimo discovered how to reliably measure
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`arterial oxygen saturation, even in the presence of motion and low blood flow, without drawing
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`blood. This was a major breakthrough in the field of pulse oximetry. Masimo manufactures and
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`sells pulse oximeters with this technology that caregivers use to monitor over 200 million patients
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`a year. By developing various consumer products, Masimo has now made its hospital-grade
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`technology directly available to everyone. Overcrowded hospitals nationwide have used Masimo’s
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`leading pulse oximetry to monitor COVID-19 patients at home.
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`One of the most commonly monitored physiological parameters is arterial oxygen
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`saturation, which indicates the extent hemoglobin is carrying oxygen. Pulse oximetry measures
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`arterial oxygen saturation by shining light of
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`particular wavelengths into an individual’s
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`tissue carrying blood and measuring the light
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`after it has interacted with the tissue. See ’745
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`patent 1:54-2:4. Pulse oximetry is non-invasive
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`because it does not require a blood draw. As shown in the picture, the sensor on an individual’s
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`finger shines light into the finger and detects the resulting light signal. Id. at 2:5-18. A monitor
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`receives that resulting light signal and calculates several physiological parameters, principally
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`pulse rate and oxygen saturation. Id.
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`Early pulse oximeters had a serious flaw—they were unreliable and falsely alarmed during
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`patient movement. The false alarms not only diverted hospital staff resources, but also would
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`cause clinicians and nurses to ignore the alarms. This became known as the “crying wolf”
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`syndrome, which led to numerous preventable deaths, and blind babies. Experts considered the
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`problem of unreliable readings and numerous false alarms “unsolvable.” In 1989, Kiani founded
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`Masimo to solve the motion problem. The technology solution is called Masimo SET®. It largely
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`eliminated the false measurements and false alarms caused by motion. Top U.S. hospitals use
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`Masimo SET® throughout the hospital. Masimo SET® technology has not only been shown in
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`over 100 independent studies to outperform other pulse oximetry technology, but it has also been
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`proven to make a clinical difference, from reducing blindness in babies to helping save lives in the
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`general ward. Masimo protected its innovations through numerous patents.
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`Pulse oximetry systems rely on light that is transmitted into body tissue to non-invasively
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`determine the oxygen saturation levels of an individual’s arterial blood. The received light, after
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`attenuation by various components of the body tissue, including the pulsing arterial blood, is
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`known in the field as a photoplethysmograph, pleth, or “PPG.” See ’127 patent 2:14-33. Non-
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`invasive measurements from the PPG were plagued by unreliability until Masimo’s pioneering
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`technology dramatically improved the reliability of monitoring and reporting physiological signals
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`derived from the PPG.
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`Pulse oximetry technology relies on the differences in the light absorption of oxygen-bound
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`and oxygen-unbound blood hemoglobin. Ex. 1 (Madisetti Initial Report) ¶ 32. Hemoglobin binds
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`with oxygen in the lungs to allow transportation of oxygen through the human body. Id. The surge
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`of blood flow entering the arteries causes a pulse, whereas venous blood returning from the
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`capillaries is largely non-pulsatile. Id. Pulse oximeters typically include two light sources, which
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`can be light-emitting diodes (LEDs) that transmit light at red and infrared wavelengths into an
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`individual’s tissue, including the oxygen-carrying arteries. Id. at ¶ 33; ’501 Patent at 2:17-23.
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`Some of the transmitted light is absorbed by the tissue and pulsating blood flow. Bright red
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`oxygenated blood absorbs light differently than dark red deoxygenated blood. Ex. 1 (Madisetti
`
`Initial Report) ¶ 34. A sensor detects the light from both wavelengths. The ratio of light absorbed
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`at red wavelengths compared to light absorbed at infrared wavelengths indicates the amount of
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`hemoglobin carrying oxygen. Id. That is known as oxygen saturation. Id.
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`As the blood flow pulsates, it changes, or modulates, the light absorption. Id. at 14. The
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`pulse oximeter tracks the changes in light absorbance as the blood pulsates. Id. at 34. Pulse
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`oximetry systems can track the changes in light absorbance as the blood pulsates by two different
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`methods: transmittance and reflectance. See ’501 patent 2:17-20. Because light both transmits
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`through tissue and backscatters or reflects back after entering tissue, pulse oximeter sensors can
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`operate either by transmittance or reflectance. For pulse oximeter sensors operating by
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`transmittance, the detector (sometimes referred to as a photodiode) and emitter are on opposite
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`sides of the tissue at the measurement site. See Ex. 1 (Madisetti Initial Report) ¶ 36 (citing Ex. 6
`at 36
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`(1997)
`
`(“Webster”))
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`(Design of Pulse Oximeters, Webster
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`J.G
`
`(ed.)
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`(APL_MAS_ITC_00015670)). For pulse oximeter sensors operating by reflectance, a detector is
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`placed on the same side as the emitters. Id. Both methods are illustrated below.
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`Transmittance
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`Reflectance
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`
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`Light traveling through the measurement sight is absorbed by various substances such as
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`skin pigmentation, bones, tissue, and arterial and venous blood. Id. at ¶ 38. The resulting light
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`absorption at the detector also varies due to the blood volume change of arterial blood. Id. The
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`resulting signal detected by the sensor is known in the field as plethysmograph, “pleth,” or PPG
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`as described above. The figure below (not to scale) illustrates the pleth (measuring changes in
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`pulsatile arterial blood), as well as other relatively constant substances that absorb light:
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`Id. at ¶ 39. If the figure were to scale, the tissue and bone portion of the signal would make up
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`about 99 percent of the overall height of the chart.
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` See Ex. 6 (Webster) at 47
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`(APL_MAS_ITC_00015681). Because the amount of tissue, bone, venous blood, and constant
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`(non-pulsating) arterial blood at a given measurement site are relatively constant over time,
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`changes in the amount of light absorbed correlate with the pulsation of arterial blood. Id.
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`The relatively constant, non-pulsating component of the pleth is often referred to as “DC”
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`or direct current, and the pulsating arterial blood component of the pleth is often referred to as
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`“AC” or alternating current. Id. at ¶ 40. The pleth is the combination of the AC and DC
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`components, as depicted in the simplified example below:
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`Id.
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`LEDs have been commonly used in pulse oximetry as light sources. The light emitted by
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`an LED includes a narrow band of wavelengths. Ex. 3 (Goldberg Report) ¶ 18. An accurate
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`measurement by a pulse oximeter relies on the system knowing the wavelength of light emitted by
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`each of the LEDs during the actual physiological measurement process. Id. at ¶ 20. A “nominal”
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`wavelength refers to the peak wavelength of an emitter’s emission spectrum measured under
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`certain specified conditions. Id. at ¶ 19. Under operating conditions, the “operating” wavelength
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`of an LED may vary from its nominal wavelength. Id. at ¶ 20. For example, an LED’s operating
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`wavelength varies with temperature. Id.
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`B.
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`The Asserted Patents
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`The asserted patents relate to devices that include multiple optical sources that emit light
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`at different wavelengths and one or more light detectors. The light detector detects the optical
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`radiation from the optical sources after the light passes through tissue. The detector outputs a
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`respective signal stream responsive to this detection. The data from the signal stream is then
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`processed and displayed as a measurement of a physiological parameter of a user.
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`1.
`
`The ’501, ’502, and ’648 Patents
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`The ’501, ’502, and ’648 patents share the same specification and relate to sensors that
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`include a novel combination of structural features to improve the accuracy of measurements by,
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`inter alia, limiting light noise. Figure 7(b) of the ’501 patent shows one configuration of a
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`transmittance sensor with a convex surface:
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`The parties dispute the meaning of “bulk measurement,” which appears in four dependent
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`claims in the ’501, ’502, and ’648 patents. An exemplary use of the disputed claim language is
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`found in claim 13 of the ’501 patent, which depends from claim 1:
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`Claim 13: The user-worn device of claim 1, wherein the one or more processors
`are further configured to process the one or more signals to determine a bulk
`measurement responsive to a positioning of the user-worn device.
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`The claimed “one or more processors” are recited in the last element of Claim 1:
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`Claim 1: A user-worn device configured to non-invasively measure a physiological
`parameter of a user, the user-worn device comprising:
`at least three light emitting diodes (LEDs);
`at least three photodiodes arranged on an interior surface of the user-worn device
`and configured to receive light attenuated by tissue of the user;
`a protrusion arranged over the interior surface, the protrusion comprising a
`convex surface and a plurality of openings extending through the protrusion and
`positioned over the three photodiodes, the openings each comprising an opaque
`lateral surface, the plurality of openings configured to allow light to reach the
`photodiodes, the opaque lateral surface configured to avoid light piping through
`the protrusion; and
`one or more processors configured to receive one or more signals from the
`photodiodes and calculate a measurement of the physiological parameter of the
`user.
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`As stated in claim 13, the processor determines a “bulk measurement” using the one or
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`more signals, and that measurement is responsive to a positioning of the user worn device.
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`2.
`
`The ’745 Patent
`
`The ’745 patent relates to monitoring devices with structural features that improve the
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`accuracy of measurement. The asserted claims include material that alters the shape of light from
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`a first shape to a second shape. Figure 3 of the ’745 patent depicts the optical source (302) and
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`material (304) that alters the shape of light:
`
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`The parties dispute the meaning of “second shape.” An exemplary use of the disputed
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`claim language is found in claim 1 of the ’745 patent:
`
`Claim 1: A physiological monitoring device comprising:
`a plurality of light-emitting diodes configured to emit light in a first shape;
`a material configured to be positioned between the plurality of light-emitting
`diodes and tissue on a wrist of a user when the physiological monitoring device
`is in use, the material configured to change the first shape into a second
`shape by which the light emitted from one or more of the plurality of light-
`emitting diodes is projected towards the tissue;
`a plurality of photodiodes configured to detect at least a portion of the light after
`the at least the portion of the light passes through the tissue, the plurality of
`photodiodes further configured to output at least one signal responsive to the
`detected light;
`a surface comprising a dark-colored coating, the surface configured to be
`positioned between the plurality of photodiodes and the tissue when the
`physiological monitoring device is in use, wherein an opening defined in the
`dark-colored coating is configured to allow at least a portion of light reflected
`from the tissue to pass through the surface;
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`a light block configured to prevent at least a portion of the light emitted from the
`plurality of light-emitting diodes from reaching the plurality of photodiodes
`without first reaching the tissue; and
`a processor configured to receive and process the outputted at least one signal and
`determine a physiological parameter of the user responsive to the outputted at
`least one signal.
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`3.
`
`The ’127 Patent
`
`The ’127 patent claims a sensor which accounts for changes in an LED’s operating
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`wavelength due to changes in temperature. The sensor includes a plurality of LEDs that each have
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`a nominal wavelength. The sensor also includes a thermal mass and a temperature sensor to
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`determine the temperature of that thermal mass. Based on that temperature, a processor determines
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`a more accurate physiological parameter. Figure 12 of the ’127 patent illustrates some of the
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`limitations of claim 7:
`
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`Figure 12 depicts a “thermal mass disposed within a substrate” that is thermally coupled to the
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`LEDs and a temperature sensor. The specification explains that the thermal mass “stabilizes and
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`normalizes the bulk temperature.” ’127 Patent at 11:1-4; see also Ex. 3 (Goldberg Report) ¶ 22.
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`The parties dispute the meaning of “plurality of operating wavelengths” in the ’127 patent.
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`An exemplary use of the disputed claim language is found in claim 7 of the ’127 patent:
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`Claim 7: A physiological sensor capable of emitting light into tissue and producing
`an output signal usable to determine one or more physiological parameters of a
`patient, the physiological sensor comprising:
`a thermal mass;
`a plurality of light emitting sources, including a substrate of the plurality of
`light emitting sources, thermally coupled to the thermal mass, the sources
`having a corresponding plurality of operating wavelengths, the thermal
`mass disposed within the substrate;
`a temperature sensor thermally coupled to the thermal mass and capable of
`determining a bulk temperature for the thermal mass, the operating
`wavelengths dependent on the bulk temperature; and
`a detector capable of detecting light emitted by the light emitting sources
`after tissue attenuation, wherein the detector is capable of outputting a
`signal usable to determine one or more physiological parameters of a patient
`based upon the operating wavelengths.
`
`III. LEGAL STANDARDS
`
`A.
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`Claim Construction
`
`Courts construe claims according to the meaning they would have to a person of ordinary
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`skill in the art (“POSA”) at the time the application was filed, in view of the intrinsic evidence:
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`the claims, the specification, and prosecution history. See Phillips v. AWH Corp., 415 F.3d 1303,
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`1312-13 (Fed. Cir. 2005) (en banc). The construction of claims is simply a way of elaborating the
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`normally terse claim language in order to understand and explain, but not to change, the scope of
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`the claims. Terlep v. Brinkmann Corp., 418 F.3d 1379, 1382 (Fed. Cir. 2005). The prosecution
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`history of a related patent forms part of the intrinsic evidence if, for example, it addresses a
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`limitation in common with the patent in suit. See Advanced Cardiovascular Sys. v. Medtronic,
`
`Inc., 265 F.3d 1294, 1305 (Fed. Cir. 2001).
`
`Although claim construction is ultimately a question of law, it is based on underlying
`
`factual considerations. Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S.Ct. 831, 835 (2015). The
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`specification “is always highly relevant to the claim construction analysis” and is “the single best
`
`guide to the meaning of a disputed term.” Vitrionics Corp. v. Conceptronic, Inc., 90 F.3d 1576,
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`1582 (Fed. Cir. 1996). “The construction that stays true to the claim language and most naturally
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`aligns with the patent’s description of the invention will be, in the end, the correct construction.”
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`Phillips, 415 F.3d at 1316 (citation and quotation omitted).
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`“The specification may reveal a special definition given to a claim term by the patentee
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`that differs from the meaning it would otherwise possess.” Id. at 1316. A specification may define
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`terms expressly or by implication. Id. at 1321 (citing Vitrionics, 90 F.3d at 1582). If a claim term
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`has no plain or established meaning in the art, such term “ordinarily cannot be construed broader
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`than the disclosure in the specification.” Indacon v. Facebook, 824 F.3d 1352, 1357 (Fed. Cir.
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`2016).
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`Like the specification, the prosecution history provides evidence of how the Patent Office
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`and inventor understood the patent. Phillips, 415 F.3d at 1317. Also, the prosecution history may
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`demonstrate whether the inventor limited the invention, making the claim scope narrower than it
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`would otherwise be. Id.
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`After reviewing the intrinsic evidence, courts may consider extrinsic evidence, including
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`expert testimony, dictionaries, and treatises. Phillips, 415 F.3d at 1314. Extrinsic evidence
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`consists of all evidence external to the patent and prosecution history, including expert and
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`inventor testimony, dictionaries, and learned treatises. Vitronics, 90 F.3d at 1584. Extrinsic
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`evidence in the form of expert testimony “can be useful to a court for a variety of purposes, such
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`as to provide background on the technology at issue, to explain how an invention works, to ensure
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`that the court’s understanding of the technical aspects of the patent is consistent with that of a
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`person of skill in the art, or to establish that a particular term in the patent . . . has a particular
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`meaning in the pertinent field.” Phillips, 415 F.3d at 1318. However, extrinsic evidence is “less
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`significant than the intrinsic record” since it is generally “less reliable.” Id. at 1317-18. The Court
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`should disregard extrinsic evidence that is at odds with the intrinsic record. Id. at 1317.
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`B.
`
`Indefiniteness
`
`A claim is indefinite only when it fails to “inform those skilled in the art about the scope
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`of the invention with reasonable certainty.” Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S.
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`898, 910 (2014). “[R]easonable certainty” does not require “absolute or mathematical precision.”
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`Biosig Instruments, Inc. v. Nautilus, Inc., 783 F.3d 1374, 1381 (Fed. Cir. 2015). While the scope
`
`of the claims must be clear enough to “apprise the public of what is still open to them,” Markman
`
`v. Westview Instruments, Inc., 517 U.S. 370, 373 (1996), “the definiteness requirement must take
`
`into account the inherent limitations of language.” Nautilus, 572 U.S. at 909 (internal citations
`
`omitted). Thus, “the certainty which the law requires in patents is not greater than is reasonable,
`
`having regard to their subject-matter.” Id. at 910. Indefiniteness is a question of law, subject to a
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`determination of underlying facts. Akzo Nobel Coatings, Inc. v. Dow Chem. Co., 811 F.3d 1334,
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`1343-44 (Fed. Cir. 2016). An accused infringer must prove indefiniteness by clear and convincing
`
`evidence. BASF Corp. v. Johnson Matthey Inc., 875 F.3d 1360, 1365 (Fed. Cir. 2017).
`
`IV. PERSON OF ORDINARY SKILL IN THE ART
`
`With respect to the ’501, ’502, ’648, and ’745 patents, Apple has proposed the following
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`definition of a POSA:
`
`[A] person with a working knowledge of physiological monitoring technologies.
`The person would have had a Bachelor of Science degree in an academic discipline
`emphasizing the design of electrical, computer, or software technologies, in
`combination with training or at least one to two years of related work experience
`with capture and processing of data or information, including but not limited to
`physiological monitoring technologies. Alternatively, the person could have also
`had a Master of Science degree in a relevant academic discipline with less than a
`year of related work experience in the same discipline.
`
`See Ex. 4 (Warren Initial Report) ¶ 32; see also Ex. 16 (Apple’s Preliminary Invalidity
`
`Contentions) at 6, 241. For the purposes of this Investigation, Masimo does not dispute this
`
`definition. Masimo has applied it to all the asserted patents, including the ’127 patent.
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`With respect to the ’127 patent, Apple has proposed the following definition of a POSA:
`
`[A] person with a working knowledge of physiological monitoring and thermal
`management technologies. The person would have had a Bachelor of Science
`degree in an academic discipline emphasizing the design of electrical and thermal
`technologies, in combination with training or at least one to two years of related
`work experience with capture and processing of data or information, including but
`not limited to physiological monitoring technologies. Alternatively, the person
`could have also had a Master of Science degree in a relevant academic discipline
`with less than a year of related work experience in the same discipline.
`
`See Ex. 16 (Apple’s Preliminary Invalidity Contentions) at 396. Masimo disagrees with this
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`definition to the extent it would require a POSA to have had a degree in an academic discipline
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`that emphasized the design of both electrical and thermal technologies. See Ex. 3 (Goldberg
`
`Report) ¶ 11. It is unlikely a degree in thermal technologies as an academic discipline existed at
`
`the relevant time. Id. In addition, the ’127 patent specification and asserted claims relate to a
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`physiological sensor. That sensor includes multiple features, such as LEDs, a detector, and
`
`processing to calculate physiological parameters of a patient. In certain embodiments, the sensor
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`also includes a temperature sensor and temperature-related features. Even if the ALJ were to apply
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`Apple’s proposed definition, that would not change the analysis with respect to the disputed claim
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`phrase “plurality of operating wavelengths.” Id. at 11.
`
`V. ARGUMENT
`
`A.
`
`Bulk Measurement
`
`(’501 Patent, Claim 13; ’502 Patent, Claim 12; ’648 Patent, Claims 2, 21)
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`-14-
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`17
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`Masimo’s Proposed Construction
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`Apple’s Proposed Construction
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`“baseline measurement”
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`Indefinite as used in asserted claims
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`’501 Patent, Claim 13; ’648 Patent, Claims 2
`and 21 (i.e., “wherein the one or more
`processors are further configured to process
`the one or more signals to determine a bulk
`measurement”)
`
`’502 Patent, Claim 12 (i.e., “wherein the one
`or more processors are further configured to
`calculate a bulk measurement”)
`
`The phrase “bulk measurement” is readily understandable to one of skill in the art. That
`
`understanding becomes apparent in view of the technology and how the phrase “bulk
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`measurement” is used in the claims and specification. Thus, Masimo provides a plain language
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`construction of the phrase consistent with the intrinsic and extrinsic evidence.
`
`1.
`
`The Intrinsic Evidence Supports Masimo’s Construction
`
`The intrinsic evidence, including the claim language and specification, supports Masimo’s
`
`proposed construction of “bulk measurement” as “baseline measurement.” The phrase “bulk
`
`measurement” appears in four dependent claims reciting one or more processors configured to
`
`process or calculate that measurement.
`
`The specification describes both a “bulk, non-pulsatile” measurement and a “pulsatile”
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`measurement of a signal. See, e.g., ’501 Patent at 34:35-40. The specification repeatedly equates
`
`a “bulk measurement” with a “non-pulsatile” measurement:
`
`Some embodiments can employ a bulk, non-pulsatile measurement in order to
`confirm or validate a pulsatile measurement. In addition, both the non-pulsatile
`and pulsatile measurements can employ, among other things, the multi-stream
`operation described above in order to attain sufficient SNR.
`
`Id. (emphasis added).
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`-15-
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`18
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`

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`For example, as noted, the non-pulsatile, bulk measurements can be combined
`with pulsatile measurements to more accurately measure analytes like glucose.
`In particular, the non-pulsatile, bulk measurement can be used to confirm or
`validate the amount of glucose, protein, etc. in the pulsatile measurements
`taken at the tissue at the measurement site(s) 1302. The pulsatile measurements
`can be used to measure the amount of glucose, hemoglobin, or the like that is
`present in the blood. Accordingly, these different measurements can be combined
`to thus determine analytes like blood glucose.
`
`Id. at 35:41-50 (emphasis added); see also Ex. 1 (Madisetti Initial Report) ¶¶ 44-46.
`
`A POSA would understand that the non-pulsatile measurement refers to the portion of the
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`measurement that does not change with the user’s heartbeat or pulse. Ex. 1 (Madisetti Initial
`
`Report) ¶¶ 39-40. Both parties agree that a POSA normally refers to that non-pulsatile
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`measurement as “DC” for direct current. Id. ¶ 40; see also Ex. 5 (Warren Rebuttal Report) p.4 n.1.
`
`Masimo’s expert, Dr. Madisetti, provided the following diagram of the non-pulsatile measurement
`
`to help explain the stability of the DC component:
`
`Ex. 1 (Madisetti Initial Report) ¶ 40.
`
`The specification also contrasts that bulk, non-pulsatile measurement with a pulsatile
`
`
`
`measurement.
`
`In certain embodiments, multiple detectors are employed and arranged in a spatial
`geometry. This spatial geometry provides a diversity of path lengths among at least
`some of the detectors and allows for multiple bulk and pulsatile measurements
`that are robust.
`
`’501 patent at 9:18-22 (emphasis added); see also ’501 Patent at 34:35-40; 35:41-50.
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`-16-
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`19
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`Pu