`
`By:
`
`
`On behalf of:
`Patent Owner Masimo Corporation
`Joseph R. Re (Reg. No. 31,291)
`Jarom D. Kesler (Reg. No. 57,046)
`Stephen W. Larson (Reg. No. 69,133)
`Shannon H. Lam (Reg. No. 65,614)
`KNOBBE, MARTENS, OLSON & BEAR, LLP
`2040 Main Street, 14th Floor
`Irvine, CA 92614
`Fax: (949) 760-9502
`Tel.: (949) 760-0404
`E-mail: AppleIPR2020-1722-695@knobbe.com
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`APPLE, INC.
`
`Petitioner,
`
`v.
`
`MASIMO CORPORATION,
`
`Patent Owner.
`
`
`
`
`
`
`
`IPR2020-01722
`Patent 10,470,695
`
`
`
`
`
`MASIMO RESPONSE TO PETITION FOR INTER PARTES REVIEW
`
`
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`II.
`
`INTRODUCTION ........................................................................................... 1
`
`BACKGROUND ............................................................................................. 3
`
`A.
`
`B.
`
`C.
`
`The Importance of Pulse Oximeters ...................................................... 3
`
`How Oximetry Works ........................................................................... 4
`
`The ’695 Patent ..................................................................................... 4
`
`III. OVERVIEW OF ALLEGED PRIOR ART .................................................... 7
`
`A.
`
`Sarantos (EX1014) ................................................................................ 7
`
`B. Mendelson (EX1015) ..........................................................................10
`
`C.
`
`D.
`
`Ackermans (EX1016) ..........................................................................11
`
`Chin (EX1006) ....................................................................................12
`
`IV. LEVEL OF ORDINARY SKILL IN THE ART ...........................................13
`
`V.
`
`CLAIM CONSTRUCTION ..........................................................................14
`
`VI. PETITIONER FAILS TO SHOW A REASONABLE
`LIKELIHOOD OF UNPATENTABILITY OF ANY
`CLAIM...........................................................................................................14
`
`A.
`
`B.
`
`C.
`
`Legal Background ...............................................................................14
`
`Grounds ...............................................................................................15
`
`Apple’s Grounds Ignore Differences Between Thick
`Tissue and Thin Tissue ........................................................................16
`
`-i-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`1.
`
`2.
`
`Chin’s alterations are not necessary for thick
`tissue ..........................................................................................16
`
`Diffusers can make sensors worse by reducing
`the light reaching the detector ...................................................20
`
`D. Ground 1D (Sarantos, Mendelson, Chin): Apple has
`not demonstrated the obviousness of claims 6, 14, or
`21 .........................................................................................................21
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`Apple misplaces its reliance on light passing
`through more tissue ...................................................................21
`
`Apple fails to support its similar device, similar
`way assertion .............................................................................23
`
`Apples’ naked allegation of a reasonable
`expectation of success is conclusory ........................................24
`
`Apple ignores the differences between
`Sarantos’ wrist-worn sensor and Chin’s nostril-
`based sensor ..............................................................................25
`
`Apple’s proposed modification would make
`Sarantos-Mendelson perform worse .........................................29
`
`Sarantos-Mendelson already spreads light ...............................31
`
`Apple has not met its burden to provide a prima
`facie case of obviousness against claims 6, 14,
`or 21 ..........................................................................................32
`
`E.
`
`Ground 2C (Ackermans and Chin): Apple has not
`demonstrated the obviousness of claims 6, 14, or 21 ..........................33
`
`-ii-
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`
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`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`1.
`
`2.
`
`3.
`
`4.
`
`5.
`
`6.
`
`7.
`
`Apple misplaces its reliance on light passing
`through more tissue ...................................................................34
`
`Apple fails to support its similar device, similar
`way ............................................................................................35
`
`Apples’ naked allegation of a reasonable
`expectation of success is conclusory ........................................36
`
`Apple ignores the differences between
`Ackermans’ wrist-worn sensor and Chin’s
`nostril-based sensor ...................................................................38
`
`Apple’s proposed modification would make
`Ackermans perform worse ........................................................40
`
`Ackermans already spreads light ..............................................41
`
`Apple has not met its burden to provide a prima
`facie case of obviousness against claims 6, 14,
`or 21 ..........................................................................................42
`
`VII. CONCLUSION ..............................................................................................43
`
`
`
`
`
`-iii-
`
`
`
`TABLE OF AUTHORITIES
`
`Page No(s).
`
`ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc.,
`694 F.3d 1312 (Fed. Cir. 2012) .......................................................................... 14
`
`CFMT, Inc. v. YieldUp Int’l Corp.,
`349 F.3d 1333 (Fed. Cir. 2003) .......................................................................... 14
`
`In re Gordon,
`733 F.2d 900 (Fed. Cir. 1984) ............................................................................ 15
`
`In re Kahn,
`441 F.3d 977 (Fed. Cir. 2006) ...................................................................... 23, 35
`
`In re Kotzab,
`217 F.3d 1365 (Fed. Cir. 2000) .......................................................................... 15
`
`Masimo Corp. v. Philips Elec. N. Am. Corp.,
`C.A. No. 09–80–LPS, 2015 WL 2379485
`(D. Del. May 18, 2015) ......................................................................................... 3
`
`In re NTP, Inc.,
`654 F.3d 1279 (Fed. Cir. 2011) .......................................................................... 15
`
`Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc.,
`520 F.3d 1358 (Fed. Cir. 2008) .......................................................................... 15
`
`PersonalWeb Technologies, LLC v. Apple, Inc.,
`848 F.3d 987 (Fed. Cir. 2017) ...................................................................... 23, 35
`
`Phillips v. AWH Corp.,
`415 F.3d 1303 (Fed. Cir. 2005) (en banc) .......................................................... 14
`
`In re Royka,
`490 F.2d 981 (C.C.P.A. 1974) ............................................................................ 14
`
`Star Sci., Inc. v. R.J. Reynolds Tobacco Co.,
`655 F.3d 1364 (Fed. Cir. 2011) .......................................................................... 15
`
`-iv-
`
`
`
`TABLE OF AUTHORITIES
`(cont’d)
`
`OTHER AUTHORITIES
`
`Page No(s).
`
`35 U.S.C. § 103 ........................................................................................................ 16
`
`35 U.S.C. § 253 ........................................................................................................ 15
`
`37 C.F.R. § 42.100 ................................................................................................... 14
`
`
`
`
`
`
`
`-v-
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`IPR2020-01722
`Apple v. Masimo – Patent 10,470,695
`
`I.
`
`INTRODUCTION
`
`Non-invasive blood constituent monitoring has almost limitless potential to
`
`inform users and caregivers about the physiological wellness of a wearer of a sensor.
`
`Of importance, and therefore, of medical emphasis, is information relating to a
`
`wearer’s oxygen supply and pulse rate. Hence the development of non-invasive
`
`pulse oximetry. Masimo, the owner of U.S. Patent No. 10,470,695 (the “’695
`
`Patent”), is the world leader in pulse oximeters. As COVID-19 overwhelmed
`
`hospital capacity in 2020, Masimo’s pulse oximeters allowed caregivers to monitor
`
`COVID-19 and suspected COVID-19 patients both in the hospital setting and from
`
`their homes. See generally EX2007. Pulse oximetry
`
`is now universally
`
`recommended for at-home patients with COVID-19 symptoms. See EX2006 at 5.
`
`Pulse oximeters, however, rely on light that probes locations on the body
`
`having perfused oxygenated blood, such as in the fingers, ears, toes, the nose, and
`
`the forehead. EX2001 ¶ 27. While these measurement sites are acceptable for
`
`caregiver monitoring environments, such locations are inconvenient for home or
`
`ambulatory use. Id. Normal routines require freedom of motion for daily activities,
`
`including movement, exercise, and sports. Id.
`
`The ’695 Patent discloses a reflective pulse oximeter particularly useful for
`
`placement on the “wrist.” EX1001 at 10:47. The ’695 Patent’s innovative reflective
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`-1-
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`IPR2020-01722
`Apple v. Masimo – Patent 10,470,695
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`sensor includes a diffuser to distribute light in a manner that increases a likelihood
`
`that reflected light will be probative of measurable blood in the wrist.
`
`Masimo reduced the number of issues in this proceeding by statutorily
`
`disclaiming several claims. EX2004. The remaining claims recite the addition of a
`
`diffuser to the ’695 Patent’s wrist sensor. As to these claims, Apple has not met its
`
`burden to provide a prima facie case of obviousness.
`
`Petitioner, Apple, combines the teachings of Chin with Sarantos-Mendelson
`
`(Ground 1D) and Ackermans (Ground 2C). But Apple either ignores or fails to
`
`appreciate the inherent differences between the amount of tissue available to a wrist
`
`worn sensor, as disclosed by Sarantos and Ackermans, versus that available to a
`
`nostril sensor, as disclosed by Chin. When, like in Chin, there is thin tissue, Chin
`
`suggests multiple modifications, including the inclusion of a diffuser, to attempt to
`
`increase the amount of tissue probed by light due to the thinness of the tissue at the
`
`nose. A wrist-worn sensor, however, is applied to thick tissue at the wrist. While the
`
`wrist has other characteristics that make it a poor measurement site, a POSITA
`
`would have understood that the wrist does not have the thin tissue backscattering
`
`problem that Chin addresses. Adding a diffuser to the Sarantos-Mendelson or
`
`Ackerman wrist sensors using Chin’s teachings attempts to solve a problem the wrist
`
`measurement site does not have. When there is thick tissue, like in Sarantos,
`
`Mendelson, or Ackermans, the addition of a diffuser undesirably reduces an amount
`
`-2-
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`IPR2020-01722
`Apple v. Masimo – Patent 10,470,695
`
`of light that reaches the detector. Apple provides no legitimate basis for why a
`
`POSITA, having a Sarantos-Mendelson device, or an Ackermans device, would
`
`modify such devices to include Chin’s diffuser, when such modification is unneeded
`
`and undesired.
`
`For at least these reasons, Apple fails to demonstrate the asserted references
`
`render the claims obvious. The Board should affirm the patentability of the
`
`challenged claims of the ’695 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. EX2001 ¶ 25. Pulse oximeters readily
`
`detect changes in a person’s oxygen saturation, which is an indicator of the person’s
`
`oxygen levels. EX1001 at 1:50-53. Use of pulse oximeters are a standard of care and
`
`an essential diagnostic tool in the U.S. throughout clinical care settings. Masimo
`
`revolutionized pulse oximetry 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 . . . took licenses
`
`from Masimo for innovative technology that saved thousands of lives and billions
`
`of dollars in healthcare costs.”).
`
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`IPR2020-01722
`Apple v. Masimo – Patent 10,470,695
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`B. How Oximetry Works
`
`A pulse oximeter’s non-invasive sensor generally includes “one or more light-
`
`emitting diodes (LEDs) and a photodetector.” EX1001 at 2:1-5. “The detector is
`
`responsive to the emitted light after attenuation or reflection by pulsatile blood
`
`flowing in the tissue site.” Id. at 2:8-10. The detector outputs a signal that is
`
`processed, then an empirically derived lookup table is used to convert processed
`
`signals into a numerical readout of physiological parameters such as oxygen
`
`saturation (SpO2) and/or pulse rate. Id. at 2:10-14.
`
`Because light both transmits through tissue and backscatters or reflects back
`
`after entering tissue, pulse oximeter sensors can operate either by transmittance or
`
`reflectance. EX2001 ¶ 28. Reflective pulse oximetry is a method by which the
`
`emitter and detector are located on the same side of the tissue measurement site. Id.;
`
`EX1001 at 10:14-16. Transmittance pulse oximetry is a method by which the emitter
`
`and detector are located on opposite sides of the tissue measurement site. EX2001
`
`¶ 28. Typically, optical systems for reflective and transmittance pulse oximeters are
`
`designed differently. Id.
`
`C. The ’695 Patent
`
`Emitters are typically very small. Because the emitter has negligible
`
`dimension, the emitter is effectively a point. EX1001 at 5:44-46. In theory, using
`
`such an emitter, as shown in FIG. 6 below, is thought to reduce differences in the
`
`-4-
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`
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`IPR2020-01722
`Apple v. Masimo – Patent 10,470,695
`
`length the light 620 as it travels from the emitter 602 to the detector 610. Id. at 5:66–
`
`6:1. This difference is commonly referred to as path length variability. Reducing the
`
`variability in the path length produces a more accurate measurement of a person’s
`
`oxygen supply or pulse rate. Id.
`
`
`
`Id. at FIG. 6 (annotated). In practice, however, tissue and blood scatter light causing
`
`the lengths of the light path to vary. Id. at 6:1-8, 10:33-36. Path length variability
`
`causes measurement errors. Id. at 6:1-8, 10:33-36.
`
`The sensors described in the ’695 Patent are designed to be worn on the wrist.
`
`EX1001 at 10:45-49. And the wrist as a measurement site presents some unique
`
`challenges. For example, the tissue at the wrist is sufficiently thick to provide ample
`
`backscattering or reflection of light. EX2001 ¶ 33; EX1001, FIG. 6 (showing tissue
`
`102 providing ample backscattering for light 620 to reflect back to the detector 610).
`
`-5-
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`IPR2020-01722
`Apple v. Masimo – Patent 10,470,695
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`The wrist, however, does not have abundant blood flow near the surface of the tissue.
`
`EX2001 at 33.
`
`Accordingly, the sensors of the ’695 Patent irradiate a larger volume of tissue
`
`than a point source emitter shown above. EX1001 at 6:55–7:3. When applied to the
`
`wrist, irradiating a larger volume of tissue increases the likelihood of light
`
`interacting with blood which is sparsely spread out in thick tissue. Id. For example,
`
`FIGS. 7A and 7B (annotated below) show a reflective sensor 700 designed to be
`
`worn on a wrist. Id. at 10:40-49.
`
`Detector
`
`Light Diffuser
`Light Blocker
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Id. at FIGS. 7A and 7B (annotated).
`
`Sensor 700 includes one or more emitters 702 (shaded orange). Id. at 10:54-
`
`55. A diffuser 704 (shaded blue) “homogenously spreads the [light] over a wide,
`
`donut-shaped area, such as the area . . . as depicted in FIG. 7B [(also shaded blue)].”
`
`-6-
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`IPR2020-01722
`Apple v. Masimo – Patent 10,470,695
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`Id. at 10:65–11:2. Sensor 700 includes a detector 710 (shaded green) located on the
`
`same side of the wrist as the emitters 702. Id. at 10:45-49. Although FIGS. 7A-7B
`
`show a single detector 710, the ’695 Patent discloses a plurality of detectors
`
`corresponding to the irradiated surface area depicted in FIG. 7B. Id. at 11:38-43.
`
`FIG. 7A depicts the path light 720 (shaded yellow) that travels from the
`
`emitters to the detectors. EX1001 at 11:44-47. Similar to FIG. 6, FIG. 7A again
`
`shows the tissue 102 at the wrist to be sufficiently thick to allow for ample light
`
`backscatter, or refection off the tissue and toward the detector. In contrast to FIG. 6,
`
`the light 720 (shaded yellow) irradiates more surface area of the tissue 102. More
`
`irradiation increases the likelihood reflective light will be probative of measurable
`
`blood, leading to “a more accurate oxygen saturation measurement.” Id. at 11:49-
`
`53; EX2001 ¶ 32.
`
`III. OVERVIEW OF ALLEGED PRIOR ART
`
`Petitioner relies on the following printed publications:
`
`A.
`
`Sarantos (EX1014)
`
`Sarantos, assigned to Fitbit, Inc., discloses a wristband wearable fitness
`
`monitor 200. EX1014 at 7:12-16. Annotated FIG. 2, below left, and the zoomed-in
`
`portion, below right, disclose a monitor 200 with light emitters 108 and a
`
`detector 212. Id. at 7:16-23. When worn by a user, the wristband monitor 200
`
`-7-
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`IPR2020-01722
`Apple v. Masimo – Patent 10,470,695
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`positions the emitters 108 and the detector 212 on the same side of the wrist,
`
`therefore, Sarantos’ disclosure focuses on a reflectance type sensor. EX2001 ¶ 39.
`
`
`
`EX1014 at FIG. 2 (annotated).
`
`In use, light from the emitters irradiate a wearer’s skin near the wrist. Id.
`
`at 7:25-30. The light backscatters, or reflects, off the tissue and emerges back out of
`
`the skin. Id. FIG. 6, below, graphs the results of a simulation to show that
`
`-8-
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`IPR2020-01722
`Apple v. Masimo – Patent 10,470,695
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`backscattered light intensity decreases with increasing distance from the emitter
`
`(simulated as centered). Id. at 10:51-67; EX2001 ¶ 40.
`
`
`
`EX1014 at FIG. 6 (colored).
`
`In order to capture more of the higher-intensity light emerging from the skin,
`
`Sarantos encourages use of its rectangular detectors (shaded blue) over the prior art
`
`square detectors (outlined blue). See EX1014 at 10:67–11:3; EX2001 ¶ 41. Sarantos
`
`also discloses that detectors should be in close proximity to emitters, typically
`
`between 1 mm to 4 mm apart. EX1014 at 18:61-66. Sarantos warns that designs
`
`outside this range “may prove counterproductive, as a higher-intensity [emitter] may
`
`be needed . . . in order to obtain a sufficiently strong signal at the []detector.” Id. at
`
`-9-
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`IPR2020-01722
`Apple v. Masimo – Patent 10,470,695
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`19:13-18. A higher-intensity emitter, and/or driving an emitter harder to generate
`
`more intensity, consumes additional power, which “may be undesirable in a
`
`wearable fitness monitor context.” Id. at 19:18-21. Wrist-worn monitors, like those
`
`of Sarantos, are battery powered. EX2001 ¶ 41. Consuming additional power lowers
`
`battery life and is undesirable. Id.
`
`Sarantos does not disclose a diffuser.
`
`B. Mendelson (EX1015)
`
`Mendelson describes a reflectance type sensor tested on the forearm and calf.
`
`EX1015 at Abstract. FIG 1., annotated below, depicts the reflectance sensor.
`
`Id. at Fig. 1 (annotated).
`
`-10-
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`IPR2020-01722
`Apple v. Masimo – Patent 10,470,695
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`Mendelson does not disclose a diffuser.
`
`C. Ackermans (EX1016)
`
`Ackermans describes arranging reflectance type sensors 10 into nodes of a
`
`“hexagonal lattice structure,” as shown below EX1016 at 9:33-34.
`
`
`
`Id. at FIG. 4. In one embodiment, Ackermans discloses that its sensor attaches to the
`
`wrist as a wristwatch. Id. at 12:29-32.
`
`FIG. 1, annotated below, shows a sensor 10 of one of its nodes having a
`
`detector 30 peripheral to an emitter 20. Id. at Abstract.
`
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`IPR2020-01722
`Apple v. Masimo – Patent 10,470,695
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`Id. at FIG. 1 (annotated). The emitter 20 irradiates the skin with light 21. Id. As
`
`shown above, the emitted light 21 spreads as it travels toward the skin. EX2001 ¶ 46.
`
`The light 21 backscatters, or reflects off tissue, and the returning light 31 travels
`
`toward detector 30. EX1016 at 5:2-4.
`
`Ackermans does not disclose a diffuser.
`
`D. Chin (EX1006)
`
`Chin describes a transmittance-type nostril sensor for measuring oxygen
`
`saturation and pulse rate. EX1006 at 1:14-21, 8:21-29. FIGS 7A and 7B, annotated
`
`below, provide that the sensor includes a piece of bent metal 170 having a detector
`
`178 (shaded blue) offset from an emitter 176 (shaded red). Id. at 8:22-24.
`
`
`
`Id. at FIGS. 7A-7B. A heater 60 and the offset configuration of the emitter and
`
`detector cause “light emitted by the emitters to pass through more blood-perfused
`
`tissue to reach the detector.” Id. at Abstract, 2:55-57.
`
`The nostril sensor may include an optional optical diffuser 180 (shaded brown
`
`above) for diffusing the light from emitter 176. EX1006 at 8:24-28. Chin’s entire
`
`treatment and disclosure of diffuser 180 is as follows: “Also shown is an optional
`
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`Apple v. Masimo – Patent 10,470,695
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`optical diffuser 180 for diffusing the light from emitter 176, which causes a further
`
`spreading or mixing of light and may enhance the amount of tissue penetrated in
`
`some instances.” Id.
`
`IV. LEVEL OF ORDINARY SKILL IN THE ART
`
`Apple asserts a POSITA “would have been a person with a working
`
`knowledge of physiological monitoring technologies. The [POSITA] 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.”
`
`Petition, Paper 2, 4-5 (“Pet.”). Apple asserts “[a]lternatively, 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.” Id. at 5.
`
`Masimo notes that Apple’s asserted level of skill (1) requires no coursework,
`
`training or experience with optics or optical physiological monitors; (2) requires no
`
`coursework, training, or experience in physiology; and (3) focuses on data
`
`processing and not sensor design. For this proceeding, Masimo nonetheless applies
`
`Apple’s asserted level of skill. EX2001 ¶¶ 34-36.
`
`-13-
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`IPR2020-01722
`Apple v. Masimo – Patent 10,470,695
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`V. CLAIM CONSTRUCTION
`
`In its instituting decision, the Board tentatively found no claim terms “require
`
`express construction at this time.” Institution Decision, Paper 8, at 10 (“Institution”).
`
`Masimo offers no particular claim construction herein. Thus, the Board should give
`
`the claim terms their ordinary and customary meaning, consistent with the
`
`specification, as a POSITA would understand them. 37 C.F.R. § 42.100(b); Phillips
`
`v. AWH Corp., 415 F.3d 1303, 1313 (Fed. Cir. 2005) (en banc).
`
`VI. PETITIONER FAILS TO SHOW A REASONABLE LIKELIHOOD
`OF UNPATENTABILITY OF ANY CLAIM
`
`A. Legal Background
`
`A petition based on “obviousness requires a suggestion of all limitations in a
`
`claim.” CFMT, Inc. v. YieldUp Int’l Corp., 349 F.3d 1333, 1342 (Fed. Cir. 2003)
`
`(citing In re Royka, 490 F.2d 981, 985 (C.C.P.A. 1974)). A patent claim is not
`
`obvious unless “a skilled artisan would have been motivated to combine the
`
`teachings of the prior art references to achieve the claimed invention, and that the
`
`skilled artisan would have had a reasonable expectation of success in doing so.”
`
`ActiveVideo Networks, Inc. v. Verizon Commc’ns, Inc., 694 F.3d 1312, 1327 (Fed.
`
`Cir. 2012).
`
`To prevail on any obviousness ground, a petitioner may not simply identify
`
`individual claim components—it must show why a “skilled artisan, with no
`
`knowledge of the claimed invention, would have selected these components for
`
`-14-
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`IPR2020-01722
`Apple v. Masimo – Patent 10,470,695
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`combination in the manner claimed.” In re Kotzab, 217 F.3d 1365, 1371 (Fed.
`
`Cir. 2000). The petitioner must support even simple modifications with some
`
`motivation to make the change. See In re Gordon, 733 F.2d 900, 902 (Fed. Cir.
`
`1984).
`
`An appropriate obviousness inquiry cannot involve even a “hint of hindsight.”
`
`Star Sci., Inc. v. R.J. Reynolds Tobacco Co., 655 F.3d 1364, 1375 (Fed. Cir. 2011).
`
`A petitioner may not “simply retrace[] the path of the inventor with hindsight,
`
`discount[] the number and complexity of the alternatives, and conclude[] that the
`
`invention . . . was obvious.” Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520
`
`F.3d 1358, 1364 (Fed. Cir. 2008). Likewise, “[c]are must be taken to avoid hindsight
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`reconstruction by using the patent in suit as a guide through the maze of prior art
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`references, combining the right references in the right way so as to achieve the result
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`of the claims in suit.” In re NTP, Inc., 654 F.3d 1279, 1299 (Fed. Cir. 2011) (internal
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`quotations omitted).
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`B. Grounds
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`Claims 1-5, 8, 9, 11-13, 15-19 and 22-30 have been statutorily disclaimed
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`under 35 U.S.C. § 253(a). See EX2004. Therefore, all allegations concerning
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`claims 1-5, 8, 9, 11-13, 15-19 and 22-30 are no longer at issue in this proceeding.
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`The following grounds remain at issue in this proceeding.
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`Ground Claims Challenged 35 U.S.C. § Reference/Basis
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`6, 14, 21
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`6, 14, 21
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`1D
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`2C
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`103
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`103
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`Sarantos, Mendelson, Chin
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`Ackermans, Chin
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`Claims 6 and 21 depend from claims 1 and 19, respectively, and recite “a
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`diffuser which receives, spreads, and emits the spread light, wherein the emitted
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`spread light is directed at the tissue measurement site.” EX1001 at claims 6, 21.
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`Claim 14 depends from claim 9 and recites “spreading, with a diffuser, the emitted
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`light and emitting the spread light from the diffuser to the tissue measurement site.”
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`Id. at claim 14.
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`C. Apple’s Grounds Ignore Differences Between Thick Tissue and
`Thin Tissue
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`1.
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`Chin’s alterations are not necessary for thick tissue
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`Reflectance oximetry requires light to backscatter, or reflect, off of the tissue
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`and be directed back towards the detector(s). EX1001 at 10:14-20. FIG. 6 of the ’695
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`Patent, annotated below, depicts the traditional banana-like shape of light 620
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`(shaded yellow) as it reflects off tissue 102 towards the detector 610 (shaded blue).
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`Id. at 10:27-31.
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`
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`Id. at FIG. 6 (annotated). FIG 6 does not show all the paths of light from the emitter
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`602 (shaded red). EX2001 ¶ 52. FIG. 6 instead shows likely paths of the light 620
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`that, after backscattering, eventually reach the detector 610. Id. As illustrated in
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`FIG. 6, the tissue 102 at the measurement site must be sufficiently thick for light
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`backscattering, or reflection, to occur. Id.
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`When the tissue at a measurement site is thin, it may not include sufficient
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`tissue for ample light backscattering. EX2001 ¶ 53. Less backscattering, or
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`reflection, means less light reaches the detector. Id. Less light leads to less signal,
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`and less signal leads to less accurate oxygen or pulse rate measurements. Id. The
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`tissue at a wrist measurement site is abundantly thick and does not suffer from the
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`problem Chin attempts to solve. Id.
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`Chin describes sensors worn at thin tissue measurement sites. EX1006 at 1:14-
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`21, 8:21-29. To counteract insufficient backscatter at such sites, Chin teaches the
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`addition of reflective surfaces. EX1006 at FIGS. 5C-5E (comparing the light 138 of
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`FIG. 5C with that of FIGS. 5D and 5E having added reflective surfaces).
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`EX1006 at FIGS. 5C-5E (annotated). Chin discloses that the reflective surfaces 133,
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`134, 150, provide more light to the detector. Id. at 7:13-20, 7:35-41. Chin explains:
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`[R]eflectors 133 and 134 cause the light path 136 in FIG. 5D to be
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`longer than the light path 138 in FIG. 5C. This is due to light which
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`goes across the entire appendage being reflected back in one surface,
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`and then again reflected back in from the other surface, bouncing back
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`and forth between the reflectors until it reaches the detector from the
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`emitter. In FIG. [5]C, by contrast, . . . light which would hit the edges
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`would typically be absorbed, rather than being reflected.
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`Id. (emphasis added).
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`At the nostril, the tissue is so thin that Chin employs three modifications to
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`increase the amount of tissue penetrated by light. EX2001 ¶ 55.
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`
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`EX1006 at FIG. 7B (annotated). First, Chin adds a heater 60. Id. at 2:59-62
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`(“[W]arming of the tissue … increases the amount of blood perfused . . . substantially
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`strengthen[ing] the . . . signal.”). Second, Chin offsets the emitter and detector. Id.
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`at 2:39-41 ([T]he emitters and detector are not directly opposite each other,
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`[therefore,] the light . . . pass[es] through more blood perfused tissue.”). And third,
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`Chin adds the diffuser 180. Id. at 8:25-29 (“[O]ptional optical diffuser 180 . . . may
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`enhance the amount of tissue penetrated in some instances.”). Chin’s modifications
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`seek to transform its thin tissue measurement sites by adding tissue. EX2001 ¶ 55.
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`A POSITA would understand that Chin’s extraordinary efforts to increase the
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`amount of tissue at a thin tissue measurement site are not needed at measurement
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`sites with sufficiently thick tissue. EX2001 ¶ 56. For example, Sarantos, Mendelson,
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`Ackermans, and Venkatraman position their sensors in thick tissue measurement
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`sites. EX1014 at 7:12-16 (Sarantos disclosing a wristband-type wearable fitness
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`monitor); EX1005 at 15:43-45 (Venkatraman disclosing a wrist-worn biometric
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`monitoring device); EX1015 at Abstract (Mendelson taking measurements from the
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`forearm and calf); EX1016 at 10:31-32 (Ackermans disclosing a medical optical
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`system in form of a wristwatch). Thus, all of Apple’s applied references, outside of
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`Chin, already have thick tissue measurement sites to backscatter light and do not
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`suffer the problems Chin attempts to solve. EX2001 ¶ 56.
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`2.
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`Diffusers can make sensors worse by reducing the light
`reaching the detector
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`A POSITA would have known there are drawbacks to adding a diffuser into
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`the optical system of a reflectance sensor. EX2001 ¶ 57. For example, although Chin
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`asserts that a diffuser “may enhance the amount of tissue penetrated [by light] in
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`some instances” (EX1006 at 8:26-29), a POSITA would have been aware that a
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`diffuser also reduces the amount of light that reaches the detector. EX2001 ¶ 57.
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`To confirm that a diffuser reduces light that reaches the detector, Masimo’s
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`expert, Dr. Madisetti, conducted experiments applying different diffuser materials
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`to reflectance-type sensors. Id. ¶¶ 58-59. Dr. Madisetti showed that a mostly
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`transparent diffuser reduced the amount of light that reached the detector by about
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`14% to 17%. Id. ¶ 59. Dr. Madisetti also showed that a less-transparent diffuser
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`reduced the amount of light that reached the detector by up to about 40% for infrared
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`light and about 50% for red light. Id.
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`A POSITA would have understood that less light at the detector leads to less
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`signal, and less signal leads to less accurate oxygen or pulse rate measurements. Id.
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`¶ 60. Accordingly, a POSITA would have understood that adding a diffuser to a
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`reflectance-type sensor can have significant detrimental consequences to the
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`performance of a pulse oximeter and would only apply Chin’s diffuser where
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`necessary – at a thin tissue site such as the nose. Id.
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`D. Ground 1D (Sarantos, Mendelson, Chin): Apple has not
`demonstrated the obviousness of claims 6, 14, or 21
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`The Board relies on Apple’s Petition with respect to the combination of
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`Sarantos, Mendelson, Chin without providing additional analysis. Institution at 23-
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`24. In its Petition, Apple admits its Sarantos-Mendelson combination does not
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`disclose a diffuser. Pet. at 63 (“Neither Sarantos nor Mendelson[] disclose a
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`diffuser.”). Apple does not support its assertions that a POSITA would add Chin’s
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`diffuser to a Sarantos-Mendelson device are for at least the following reasons.
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`1.
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`Apple misplaces its reliance on light passing through more
`tissue
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`Apple quotes Chin’s recitation of the benefit of a diffuser as “further sprea