`
`By:
`
`Filed on behalf of:
`Patent Owner Masimo Corporation
`Joseph R. Re (Reg. No. 31,291)
`Stephen W. Larson (Reg. No. 69,133)
`Jarom D. Kesler (Reg. No. 57,046)
`Shannon H. Lam (Reg. No. 65,614)
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, Fourteenth Floor
`Irvine, CA 92614
`Tel.: (949) 760-0404
`Fax: (949) 760-9502
`E-mail: AppleIPR2020-1526-994@knobbe.com
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`APPLE INC.
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`Patent Owner.
`
`
`
`
`
`
`
`Case IPR2020-01526
`U.S. Patent 6,771,994
`
`
`
`
`
`
`PATENT OWNER RESPONSE
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`BACKGROUND ............................................................................................. 4
`
`A.
`
`B.
`
`C.
`
`D.
`
`E.
`
`The Importance of Pulse Oximeters ...................................................... 4
`
`How Oximetry Works ........................................................................... 5
`
`The ’994 Patent ..................................................................................... 7
`
`Challenged Claim 15 ............................................................................. 8
`
`Summary of File History ....................................................................... 9
`
`III. OVERVIEW OF ALLEGED PRIOR ART .................................................... 9
`
`A. Diab (EX1006) ...................................................................................... 9
`
`B.
`
`Benjamin (EX1007) ............................................................................ 13
`
`C. Melby (EX1008) .................................................................................. 15
`
`D. Webster (EX1010) ............................................................................... 16
`
`E.
`
`Fine (EX1009) ..................................................................................... 18
`
`IV. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 21
`
`V.
`
`CLAIM CONSTRUCTION .......................................................................... 21
`
`VI. APPLE FAILS TO ESTABLISH OBVIOUSNESS OF
`CLAIM 15 ..................................................................................................... 26
`
`A.
`
`Legal Background ............................................................................... 26
`
`-i-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`B.
`
`Ground 1: Apple Fails to Establish Obviousness
`Based on Diab, Benjamin, and Melby ................................................ 28
`
`1.
`
`2.
`
`3.
`
`4.
`
`Apple’s combination would undermine Diab’s
`invention .................................................................................... 28
`
`Apple’s unexplained modification would cause
`Diab to perform worse .............................................................. 34
`
`Apple’s proposed modifications would not have
`yielded predictable results ......................................................... 37
`
`Apple’s remaining Ground 1 arguments fail to
`support Apple’s combination .................................................... 38
`
`C.
`
`Ground 2: Apple Fails to Establish Obviousness
`Based on Webster and Melby .............................................................. 42
`
`1.
`
`2.
`
`Apple conflates Webster’s wavelength filter
`and Webster’s light impervious barriers ................................... 42
`
`A POSITA would not have been motivated to
`modify Webster to include Melby’s light
`control film ................................................................................ 44
`
`D. Ground 3: Apple Fails to Establish Obviousness
`Based on Fine ...................................................................................... 46
`
`1.
`
`2.
`
`A POSITA would not have considered Fine ............................ 46
`
`Optical fibers are not louvers .................................................... 47
`
`E.
`
`Ground 4: Apple Fails to Establish Obviousness
`Based on Fine, Benjamin, and Melby ................................................. 50
`
`-ii-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`1.
`
`2.
`
`Apple’s argued motivations to combine Fine,
`Benjamin, and Melby are conclusory and
`unsupported ............................................................................... 50
`
`Apple fails to explain how a light control film
`would be incorporated into Fine ............................................... 52
`
`VII. RESERVATION OF RIGHTS ...................................................................... 57
`
`VIII. CONCLUSION .............................................................................................. 57
`
`
`
`
`
`
`
`-iii-
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc.,
`694 F.3d 1312 (Fed. Cir. 2012) .......................................................................... 25
`CCS Fitness, Inc. v. Brunswick Corp.,
`288 F.3d 1359 (Fed. Cir. 2002) .......................................................................... 20
`CFMT, Inc. v. YieldUp Int’l Corp.,
`349 F.3d 1333 (Fed. Cir. 2003) .......................................................................... 24
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) ...................................................................... 25, 31
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) ...................................................................... 37, 44
`In re Kotzab,
`217 F.3d 1365 (Fed. Cir. 2000) .......................................................................... 25
`Liebel-Flarsheim Co. v. Medrad, Inc.,
`358 F.3d 898 (Fed. Cir. 2004) ............................................................................ 23
`Masimo Corp. v. Philips Elec. N. Am. Corp.,
`C.A. No. 09–80–LPS, 2015 WL 2379485 (D. Del. May 18, 2015) ............passim
`In re NTP, Inc.,
`654 F.3d 1279 (Fed. Cir. 2011) .......................................................................... 25
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) .......................................................................... 25
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) .............................................................. 20, 23, 24
`Plas-Pak Indus., Inc. v. Sulzer Mixpac AG,
`600 F. App’x 755 (Fed. Cir. 2015) ..................................................................... 31
`
`-iv-
`
`
`
`TABLE OF AUTHORITIES
`(cont’d)
`
`Page No(s).
`
`Sorensen v. USITC,
`427 F.3d 1375 (Fed. Cir. 2005) .......................................................................... 22
`Star Sci., Inc. v. R.J. Reynolds Tobacco Co.,
`655 F.3d 1364 (Fed. Cir. 2011) .......................................................................... 25
`Tec Air, Inc. v. Denso Mfg. Michigan Inc.,
`192 F.3d 1353 ..................................................................................................... 30
`Thorner v. Sony Comput. Entm’t Am. LLC,
`669 F.3d 1362 (Fed. Cir. 2012) .......................................................................... 23
`United States v. Arthrex, Inc.,
`Nos. 19-1434, 19-1452 and 19-1458, 2021 WL 2519433
`(U.S. Sup. Ct. June 21, 2021) ............................................................................. 57
`W.L. Gore & Assocs. v. Garlock, Inc.,
`721 F.2d 1540 (Fed. Cir. 1983) .................................................................... 38, 39
`
`OTHER AUTHORITIES
`
`37 C.F.R. § 42.100 ................................................................................................... 20
`
`
`
`
`
`
`-v-
`
`
`
`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`EXHIBIT LIST
`
`Exhibit No.
`
`Description
`
`2001
`
`2002
`
`2003
`
`2004
`
`2005
`
`Declaration of Vijay K. Madisetti, Ph.D.
`
`Curriculum Vitae of Vijay K. Madisetti, Ph.D.
`
`Transcript of Deposition of Dr. Brian Anthony in connection with
`IPR2020-01526
`
`“COVID-19 Clinical management”, apps.who.int (January 25,
`2021), available at
`https://apps.who.int/iris/bitstream/handle/10665/338882/WHO-
`2019-nCoV-clinical-2021.1-eng.pdf?sequence=1&isAllowed=y
`
`“Pulse Oximeters - Premarket Notification Submissions [510(k)s]:
`Guidance for Industry and Food and Drug Administration Staff”,
`fda.gov (March 2013), available at
`https://www.fda.gov/regulatory-information/search-fda-guidance-
`documents/pulse-oximeters-premarket-notification-submissions-
`510ks-guidance-industry-and-food-and-drug
`
`2006
`
`Tamura et al., “Wearable Photoplethysmographic Sensors—Past
`and Present,” Electronics 3:282-302 (2014)
`
`2007
`
`U.S. Patent No. 4,700,708
`
`2008
`
`2009
`
`2010
`
`2011
`
`Verploegh, “Light Control Systems for Automotive
`Instrumentation,” SAE Technical Paper Series (February 24-28,
`1986)
`
`U.S. Patent No. 3,922,440
`
`U.S. Patent No. 4,938,218
`
`U.S. Patent No. 5,024,226
`
`Exhibit List, Page 1
`
`
`
`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`
`Exhibit No.
`
`Description
`
`2012
`
`Cohen et al., “A plan to save coronavirus patients from dying at
`home,” cnn.com (April 12, 2020), available at
`https://www.cnn.com/2020/04/11/health/monitoring-covid19-at-
`home/index.html
`
`2013
`
`U.S. Patent No. 5,099,842
`
`2014
`
`Hecht, Understanding Fiber Optics, Laser Light Press (5th ed.
`2015)
`
`2015
`
`Definition of “louver,” lexico.com (powered by Oxford)
`
`
`
`Exhibit List, Page 2
`
`
`
`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`I.
`INTRODUCTION
`Masimo is the world leader in pulse oximeters and owns U.S. Patent
`
`No. 6,771,994 (the “’994 Patent”). As COVID 19 overwhelmed hospital capacity
`
`in 2020, Masimo’s pulse oximeters allowed caregivers to monitor COVID-19 and
`
`suspected COVID-19 patients from their homes. The accuracy of Masimo’s pulse
`
`oximeters is essential in such critical monitoring environments because false signals
`
`can result in complications or even death. Claim 15 of the ’994 Patent recites an
`
`innovative sensor that includes louvers, which help ensure light received by a
`
`detector reflects a user’s oxygen supply and not a dangerous false signal.
`
`Apple’s obviousness challenge fails because Apple uses the ’994 Patent
`
`claims as a guide. In the process, Apple contorts the disclosure of Benjamin’s and/or
`
`Melby’s light control films into Diab’s, Webster’s, and Fine’s different oximetry
`
`sensor designs, disregarding the specific optical system of those base sensors.
`
`Apple’s combinations replace existing components with components having
`
`opposite functionality, conflate differing component objectives, and yield
`
`nonsensical results. Accordingly, a POSITA presented with Diab’s, Webster’s, and
`
`Fine’s sensors would not have been motivated to add or replace components with
`
`Benjamin’s and/or Melby’s light control film.
`
`In Ground 1, Apple relies on Diab, which does not disclose louvers. Instead,
`
`Diab discloses an innovative sensor having a recessed detector covered by a light
`
`-1-
`
`
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`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`scattering medium. EX1006 at 5:27-28. Apple claims that a POSITA would
`
`redesign Diab’s sensor with Benjamin’s and/or Melby’s light control film. But
`
`Benjamin’s and/or Melby’s light control film performs the opposite optical purpose
`
`as taught by Diab’s innovative light scattering medium. Apple’s combination is
`
`classic hindsight reconstruction.
`
`In Ground 2, Apple relies on Webster, which also does not disclose louvers.
`
`Instead, Webster discloses an optical filter over the photodiode to remove unwanted
`
`wavelengths of light. EX1010 at 79. Apple alleges that a POSITA would use
`
`Melby’s light control film in place of Webster’s optical filter, but identifies no
`
`motivation in the references for this change. The optical purposes of these two
`
`components are unrelated: Webster’s filter removes selected wavelengths of light,
`
`Melby’s film controls the direction of light. Apple’s combination would vitiate the
`
`purpose of Webster’s filter because the filter would no longer remove selected
`
`wavelengths of light. Moreover, Webster separately teaches light impervious
`
`barriers that seek to limit all light from a certain area from reaching the photodiode.
`
`Id. These barriers are not placed over the photodiode—to the contrary, they are
`
`placed anyplace but over the photodiode as placing a barrier over the photodiode
`
`would render the photodiode inoperable. That is, with the barrier blocking all light
`
`over the photodiode, the photodiode would receive no light. Apple cites nothing to
`
`-2-
`
`
`
`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`motivate the replacement of Webster’s light barriers with Melby’s light film over
`
`the photodiode.
`
`In Ground 3, Apple relies on Fine, yet another reference that does not disclose
`
`louvers. Instead, Fine discloses a fetal sensor that uses optical fibers. See EX1009
`
`at 1:8–4:6, 6:28-32. Optical fibers are not louvers, and the fetal sensor design of
`
`Fine is for a difficult monitoring environment of use inside the birth canal during
`
`delivery. Apple ignores the context of this complex sensor and the actual purpose
`
`of the fiber light guides, to argue in Ground 4, that a POSITA would simply redesign
`
`Fine’s complicated fiber-based fetal sensor with Benjamin’s and/or Melby’s light
`
`control film. Apple does not provide any reason why a POSITA would modify this
`
`complex fetal sensor at all, much less would make the proposed combination. None
`
`of Apple’s alleged combinations of Fine’s sensor with Benjamin’s and/or Melby’s
`
`light control film would improve Fine’s sensor or address any recognized deficiency
`
`in that sensor.
`
`In addition to the foregoing problems of Apple’s combinations, none of the
`
`combinations would have led to predictable results. Both experts agree that changes
`
`to the optical system could lead to changes in the signal-to-noise ratio, thereby
`
`corrupting the signal. EX2003 at 45:17–47:7; EX2001 ¶ 31. Moreover, changes in
`
`the optical path could also degrade the accuracy of the output measurement. EX2003
`
`-3-
`
`
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`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`at 50:17–51:9; EX2001 ¶ 31. Nowhere does Anthony explain why a POSITA would
`
`make the proposed sensor modifications.
`
`For at least these reasons, Apple fails to demonstrate obviousness.
`
`Accordingly, the Board should affirm the patentability of Claim 15 of the ’994
`
`Patent.
`
`II. BACKGROUND
`A.
`The Importance of Pulse Oximeters
`When a patient’s oxygen is dropping, a caregiver has only a few minutes to
`
`prevent brain damage, heart failure and death. EX1001 at 1:24-28; EX2001 ¶ 26.
`
`Pulse oximeters readily detect changes in a person’s oxygen saturation, which is an
`
`indicator of the person’s oxygen levels. EX1001 at 1:24-28; EX2001 ¶ 26. Use of
`
`pulse oximeters are a standard of care and an essential diagnostic tool in the U.S.
`
`throughout clinical care settings. EX2001 ¶ 26. Masimo is the world leader in pulse
`
`oximetry and revolutionized the technology by introducing the Masimo SET pulse
`
`oximetry technology. Courts have repeatedly recognized and credited Masimo’s
`
`innovations. See e.g., Masimo Corp. v. Philips Elec. N. Am. Corp., C.A. No. 09–
`
`80–LPS, 2015 WL 2379485, at *19 (D. Del. May 18, 2015) (“an entire industry—
`
`other than Philips and one Chinese company—took licenses from Masimo for
`
`innovative technology that saved thousands of lives and billions of dollars in
`
`healthcare costs.”). Masimo’s pulse oximeters provide essential monitoring to over
`
`-4-
`
`
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`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`200 million patients each year. When COVID 19 reached pandemic levels,
`
`overwhelming hospital capacity, Masimo’s technology was quickly put into use by
`
`hospitals to monitor COVID-19 patients from their homes. See generally EX2012.
`
`Pulse oximetry is now universally recommended for at-home patients with COVID-
`
`19 symptoms. See EX2004 at 5.
`
`B.
`How Oximetry Works
`A pulse oximeter’s non-invasive sensor generally includes “red and infrared
`
`(IR) light-emitting diode (LED) emitters and a photodiode detector.” EX1001 at
`
`1:35-36. The emitters project light through a user’s tissue, and the detector detects
`
`the light as it emerges from the tissues. Id. at 1:38-42. An oximeter device
`
`alternately activates the emitters (id. at 1:47-48), and the resulting light absorption
`
`varies due to the blood volume change of arterial blood.” Id. at 3:10-15. The
`
`detector generates a current proportional to the intensity of the detected light, and
`
`the oximeter calculates a ratio of detected red and infrared intensities.” Id. at 1:46-
`
`51. The user’s arterial oxygen saturation value is empirically determined based on
`
`the ratio obtained. Id. at 1:51-52.
`
`The calibration coefficients (often called a calibration curve) provide a map
`
`or lookup table for correlating measured and processed ratiometric data received
`
`from a pulse oximetry sensor with empirically determined oxygen saturation values.
`
`EX2001 ¶ 31. Calibration curves are sensitive to changes to any particular optical
`
`-5-
`
`
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`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`system as such changes often affect the incoming values of the ratiometric data. Id.
`
`Without an accurate calibration curve, the pulse oximeter has no way of determining
`
`accurate oxygen saturation levels. Id. For this reason, optical system modifications
`
`often require new FDA clearance. Id. ¶ 32. Because calibration curves are
`
`determined by collecting clinical data, modifying an optical system is no simple task.
`
`Instead, modifying an optical system increases the potential need for new clinical
`
`data to update the calibration curves, and even potentially requiring new FDA
`
`clearances. Id.
`
`All of Apple’s modifications fundamentally change the alleged prior art’s
`
`optical systems. Alterations in optical systems may require expensive, time
`
`consuming and clinical data collection to create the new calibration curves to avoid
`
`decreased accuracy or even malfunction. See EX1001 at 1:50-54; EX2001 ¶ 32.
`
`Apple’s expert, Dr. Brian Anthony, has done no work specific to pulse oximeter
`
`sensors, EX2003 at 20:10-13, and apparently did not appreciate the impact of his
`
`proposed modifications and how a POSITA would have understood such sensor
`
`design. Masimo asked Anthony multiple times the very basic question of how
`
`electrical signals are converted to oxygen saturation measurements. Id. at 29:14–
`
`30:15. Anthony responded that “it wasn’t necessary to fully articulate my
`
`understanding and all the background on how that is done,” offering no further
`
`information. Id. at 29:14–30:15. A POSITA would readily know the answer to
`
`-6-
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`
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`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`Masimo’s very basic question: one converts electrical signals to oxygen saturation
`
`measurements using an empirically determined lookup table (a so-called calibration
`
`curve). See EX1001 at 1:51-52. And, a POSITA would readily know that
`
`modifications to the optical system of any sensor presents a significant change to the
`
`overall system. EX2001 ¶¶ 31-32. Namely, calibration curves are specific to an
`
`optical system and costly to develop. Id. Thus, a POSITA, understanding the cost
`
`and complexity of optical changes, would not have been motivated to make the
`
`proposed modifications, particularly without any perceived benefit. Id. ¶ 32.
`
`C.
`The ’994 Patent
`The ’994 Patent discloses the need to avoid a detector producing a false signal
`
`wrongly interpreted as a signal responsive to the user’s oxygen status. EX1001 at
`
`1:18-19. One source of such errant interpretation is when a sensor “becomes
`
`partially or completely dislodged from the patient, but . . . continue[s] to detect an
`
`AC signal within the operating region of the pulse oximeter.” Id. at Abstract, 1:64-
`
`66 (emphasis added). False AC signals within an expected region of the oximeter
`
`are serious because the oximeter may display a normal saturation when, in fact, the
`
`sensor is not properly attached. See id. at 4:39-42; EX2001 ¶ 33. The ’994 Patent
`
`discloses an innovative solution that includes louvers placed in front of the
`
`photodetector to filter out oblique light rays, one possible source of false AC signals.
`
`EX1001 at Abstract, 2:9-12; EX2001 ¶ 34. The louvers “prevent light from an
`
`-7-
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`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`oblique angle from reaching the photodetector and creating a false signal that might
`
`be interpreted by the pulse oximeter as a physiological signal.” Id. at 2:16-19.
`
`For example, Fig. 5A (reproduced below) shows “[t]he louvers 502 block light
`
`rays travelling along an oblique path 410.” Id. at 6:28-30.
`
`
`
`Id. at FIG. 5A. When light rays from the emitter 220 follow a path 410 oblique to
`
`an orientation of the louvers 502, the louvers 502 prevent the passage of some light
`
`rays to the detector assembly 235. EX2001 ¶ 35. Reducing the oblique light rays
`
`improves the signal, EX1001 at 6:49-5, thereby avoiding “a false signal that could
`
`be interpreted by the pulse oximeter 140 to be a physiological signal.” Id. at 6:53-
`
`56.
`
`D.
`Challenged Claim 15
`Apple challenges Claim 15 only. Claim 15 reads:
`
`15. A sensor which generates at least first and second intensity signals
`from a light-sensitive detector which detects light of at least first and
`second wavelengths transmitted through body tissue carrying pulsing
`blood; the sensor comprising:
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`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`at least one light emission device;
`a light sensitive detector; and
`a plurality of louvers positioned over the light sensitive detector
`to accept light from the at least one light emission device originating
`from a general direction of the at least one light emission device and
`then transmitting through body tissue carrying pulsing blood, wherein
`the louvers accept the light when the sensor is properly applied to tissue
`of a patient.
`
`EX1001 (claim 15).
`E.
`Summary of File History
`The examiner issued no Office Actions during the prosecution of the
`
`’994 Patent. See generally EX1002. Patent Owner filed no amendments or
`
`arguments, and therefore, Patent Owner did not disavow any claim scope. Id.
`
`III. OVERVIEW OF ALLEGED PRIOR ART
`Apple relies on the following printed publications:
`
`A.
`Diab (EX1006)
`Diab is another patent owned by Masimo that takes a different approach to
`
`light handling than the ’994 Patent. Diab’s Background explains that non-invasive
`
`monitoring of blood oxygen saturation through reflectance and transmittance
`
`oximetry was common. EX1006 at 1:27-32 (stating, “Measurements . . . are often
`
`performed with non-invasive techniques where assessments are made by measuring
`
`the ratio of incident to transmitted (or reflected)[] light through a portion of the body,
`
`-9-
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`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`for example a digit such as a finger, or an earlobe, or a forehead.”). Diab identifies
`
`that “[m]any prior art optical probes are designed for use only when a patient is
`
`relatively motionless since . . . motion induced noise can grossly corrupt the
`
`measured signal.” Id. at 1:53-57. Diab further explains that erratic movement
`
`“causes the change in optical path length to be erratic, making the absor[p]tion
`
`erratic, resulting in a difficult to interpret measured signal.” Id. at 1:44-46.
`
`Accordingly, Diab addresses a need “for a probe which inhibits motion induced
`
`noise, or motion artifacts, during measurement of a signal while still generating a
`
`transmitted or reflected signal of sufficient intensity to be measured by a detector.”
`
`Id. at 3:4-8.
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`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`Fig. 24 of Diab “depicts one embodiment of a probe constructed in accordance
`
`with [Diab’s] invention coupled to an oximeter.” EX1006 at 17:62-65.
`
`
`
`Id. at Fig. 24 (annotated). As shown above, the finger probe 400 shows “the aperture
`
`420 and chamber 422 located directly adjacent the finger pad 404” with “[t]he
`
`photodetector 426 in the bottom 414 of the chamber 422.” Id. at 18:11-17. Chamber
`
`422 is described in more detail in Fig. 4, reproduced below. The monitored tissue
`
`“12[8] may rest above or penetrate slightly into the chamber 122 . . . .” Id. at 7:16-
`
`-11-
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`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`19. “[S]ome of the light is caused to be incident on the opaque walls 123 of the
`
`chamber 122 and is absorbed.” Id. at 7:48-50.
`
`
`
`Id. at Fig. 4 (annotated).
`
`Apple relies on Diab’s discussion of a scattering medium. Petition (Paper 2)
`
`at 19 (“Pet.”). Figure 25 of Diab shows the specific implementation of the scattering
`
`medium. Figure 25 shows “a probe wherein the aperture is filled with a compressible
`
`scattering medium [1040].” EX1006 at 5:27-28.
`
`Scattering
`Medium
`
`
`
`
`
`
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`-12-
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`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`Id. at Fig. 25 (annotated). Traditionally, “scattering was thought to degrade signal-
`
`to-noise ratios of optical signals[; therefore], previous methods have not employed
`
`optical scattering techniques.” Id. at 20:42-44. However, with Diab’s unique sensor
`
`geometry, Diab found that “[t]he scattering medium helps to minimize the effects of
`
`local artifacts and perturbations within the [tissue 1028].” Id. at 4:1-3. Additionally,
`
`Diab found the surprising result that light scattering improves the signal-to-noise
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`ratio “because there appears to be a reduced effect on the signal from any particular
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`local region of the . . . [tissue] 1028 . . . .” Id. at 20:3-6.
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`Diab further discloses that the light scattering medium 1040 is preferably
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`reticulated foam because reticulated foams provide “contact in spots rather than
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`across large areas of the flesh.” EX1006 at 20:20-25. And “[i]f contact is made
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`across large areas of flesh, microscopic droplets of perspiration or oil can form a
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`layer between the flesh and the scattering medium 1040,” which “creates an
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`impedance mismatch interface which is absor[p]tive of the optical radiation.” Id. at
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`20:25-29.
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`B.
`Benjamin (EX1007)
`Benjamin discloses a photoplethysmographic probe 10 with “[a] photo-
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`sensitive cell 20 [] mounted within the casing 12 adjacent the light source 18 so that
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`it responds to light reflected from the field to be measured and passing through the
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`window 16.” EX1007 at 2:32-36. “[A] light control film 22 is mounted within the
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`casing 12 to extend across the window 16.” Id. at 2:42-44. “The light control film 22
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`is made of a 0.030[-]inch[-]thick clear cellulose acetate butyrate film.” Id. at 2:48-
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`50. “The light control film 22 has the effect of collimating the light passing
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`therethrough to thereby make the photo-sensitive cell 20 more nearly dependent only
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`upon the light beam directly reflected from the field being measured.” Id. at 2:53-
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`57.
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`
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`Id. at Fig. 1 (annotated).
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`Benjamin identifies two problems (1) “variations in the operating point of the
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`photocell” 20 and (2) “artifactual noise produced by motion of the photo-sensitive
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`cell [20] and light source [18] with respect to the pickup site.” EX1007 at 1:35-44.
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`Benjamin addresses the first problem by teaching that “the amount of scattered light
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`reaching the photocell can be made closer to constant by placing in front of the
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`photocell and light source a small piece of light control film.” Id. at 1:56-66.
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`Benjamin addresses the second problem by minimizing the motion artifact with light
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`“emitted in a narrow band of wave lengths centering in the green.” EX1007 at 1:67–
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`2:14.1
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`C. Melby (EX1008)
`Melby discloses a light control film commonly used “to prevent light from
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`automobile control panels from reaching the windshield and causing distracting and
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`dangerous reflections at night” or “to cover the screen of a CRT or other display to
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`prevent persons other than the operator from reading displayed thereon.” EX1008
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`at 2:9-15.
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`Melby’s light control film is “a louvered plastic film [10 with] . . . a plurality
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`of clear regions [12] separated by louvers [20].” EX1008 at 3:3-4. Melby shows its
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`film 10 in cross section. Melby shows that the light (yellow arrows) that reaches
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`1 Green light is known to be more tolerant to motion artifacts when measuring
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`pulse rate. EX2001 ¶ 58.
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`clear region 12 passes through the film, but the light that approaches opaque louvers
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`20 is blocked. Id. at 3:11-12; EX2001 ¶ 61.
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`
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`Id. at Fig. 1 (annotated).
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`D. Webster (EX1010)
`Webster discloses several methods “to minimize the effects from light other
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`than the optical signals of interest.” EX1010 at 79.
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`In one example, Webster explains that “optical filtering, placed between
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`sources of light and the photodiode, is used to limit the spectral response of the
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`photodiode.” Id. “This allows light of wavelengths of interest to pass through the
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`filter but does not allow light of other wavelengths to pass through the filter.” Id.
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`In another example, Webster explains that “the pulse oximeter designer must
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`attempt to limit the light reaching the photodiode to that which has traveled through
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`tissue containing arterial blood.” Id. (internal citations omitted). Webster references
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`a different patent disclosure by New and Corenman to explain that “[l]ight
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`impervious barriers should be placed between LEDs and the photodiode in all areas
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`where the emitted light could reach the photodiode without passing through tissue
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`(New and Corenman 1987).” Id. As illustrated below, New and Coleman 1987
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`places “a light impervious barrier 136” “between photosensor 138 and the paths to
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`the light emitting diodes 130 and 132 which are not through finger 14.” EX2007 at
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`3:29-32.
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`
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`Id. at Fig. 6 (partial, annotated). “Barrier 136, terminating in contact with the flesh
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`of finger 14, make the path between the respective light emitting diodes 130, 132
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`and the light receiving diode 138 occur only through the flesh of finger 14.” Id. at
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`32-35.
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`E.
`Fine (EX1009)
`Fine discloses a fetal oximetry sensor with optical fiber bundles 63, 64.
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`EX1009 at 1:8–4:6, 6:28-32. U.S. Patent No. 4,938,218, which is described in the
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`background of Fine, explains that fetal sensors may be used to detect and treat
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`hypoxia in the fetus during labor. EX2010 at 2:37-39. “Contact with the fetus can
`
`be made after natural rupture of the amniotic membrane by manually inserting a
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`probe sensor into the uterus from the vagina.” Id. at 2:39-42. Optical fibers are used
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`in fetal monitoring because the optical fibers can extend outside the patient’s body
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`to an external light source and/or detector. EX2001 ¶ 66.
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`Fine’s sensor has laser diodes producing monochromatic light at wavelengths
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`“not available in light sources, such as LEDs used in . . . oximetry apparatuses.”
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`EX1009 at 7:10-19. Fine discloses its laser diodes as “two point-like light emitters
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`positioned in the center of the device in close proximity to each other and at least
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`one and preferably two annular detector terminals concentrically surrounding the
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`light emitters.” EX1009 at Abstract. Fig. 4 illustrates an applicator block 52 having
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`“first and second annular slots 58 and 59 concentric with bore 54.” Id. at 17:6-8.
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`Detectors
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`Fiber Optics
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`
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`Id. at Fig. 4 (annotated). “Slots 58 and 59 accommodate the free, light-acquiring
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`ends of first and second optical fiber bundles 63 and 64 which constitute first and
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`second detector terminals and pass through the inner space of [the] body 51 to
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`photodetectors 65 electrically connected through wires 67 to a cable 68.” Id. at
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`17:11-14.
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`Fig. 2 of Fine shows a plan view of an applicator block having a first annular
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`space 27 housing a plurality of optical fibers 32 and a second annular space 35
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`housing a plurality of optical fibers 39. EX1009 at 15:25–16:4. A POSITA would
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`understand that the bottom view of Fig. 4 is likely similar to Fig. 2 of Fine. EX2001
`
`¶ 68.
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`EX1009 at Fig. 2.
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