throbber
IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`Al-Ali
`In re Patent of:
`10,470,695 Attorney Docket No.: 50095-0004IP2
`U.S. Patent No.:
`November 12, 2019
`Issue Date:
`Appl. Serial No.: 16/226,249
`Filing Date:
`December 19, 2018
`Title:
`ADVANCED PULSE OXIMETRY SENSOR
`
`DECLARATION OF DR. BRIAN W. ANTHONY
`
`I, Brian W. Anthony, of Cambridge, MA, declare that:
`
`1.
`
`My name is Dr. Brian W. Anthony. I am an Associate Principal
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`Research Scientist at the Institute of Medical Engineering & Science at
`
`Massachusetts Institute of Technology (MIT). I am also a Principal Research
`
`Scientist at MIT’s Mechanical Engineering department, Director of the Master of
`
`Engineering in Advanced Manufacturing and Design Program at MIT, a Co-
`
`Director of the Medical Electronic Device Realization Center of the Institute of
`
`Medical Engineering & Science, and Associate Director of MIT.nano. My current
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`curriculum vitae is attached and some highlights follow.
`
`2.
`
`I earned my B.S. in Engineering (1994) from Carnegie Mellon
`
`University. I earned my M.S. (1998) and Ph.D. (2006) in Engineering from MIT.
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`My research focused on high-performance computation, signal processing, and
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`electro-mechanical system design.
`
`3.
`
`In 1997, I co-founded Xcitex Inc., a company that specialized in
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`video-acquisition and motion-analysis software. I served as the Chief Technology
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`APPLE 1003
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`Officer and directed and managed product development until 2006. Our first demo
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`product was an optical ring for human motion measurement used to capture user
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`hand motion in order to control the user’s interaction with a computer. Many of
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`the structural elements of our optical ring addressed the same system issues as
`
`those described and claimed in the patent at issue. For example, our optical ring
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`included multiple light emitting diodes, multiple photodetectors, techniques for
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`modulation and synchronization, and noise reduction algorithms. We estimated
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`human hand-motion based on how that motion changed the detected light. In our
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`application, we did not try to eliminate motion artifact, we tried to measure it. In
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`developing our ring, we considered well-known problems such as ambient light
`
`and noise. Motion Integrated Data Acquisition System (MiDAS) was our flagship
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`video and data acquisition product which relied upon precise synchronization of
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`multiple clocks for optical sensor and video acquisition, data acquisition, and
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`external illumination.
`
`4.
`
`I joined MIT in 2006 and was the Director of the Master of
`
`Engineering in Advance Manufacturing and Design Program for over ten years.
`
`The degree program covers four main components: Manufacturing Physics,
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`Manufacturing Systems, Product Design, and Business Fundamentals. Many of
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`the courses, projects, and papers my students undertake involve technologies
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`relevant to the patent at issue, for example, sensor devices including non-invasive
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`optical biosensors.
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`5.
`
`In 2011, I co-founded MIT’s Medical Electronic Device Realization
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`Center (“MEDRC”) and currently serve as co-director. The MEDRC aims to
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`create and deploy revolutionary medical technologies by collaborating with
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`clinicians, the microelectronics, and medical devices industries. We combine
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`expertise in computation; communications; optical, electrical, and ultrasound
`
`sensing technologies; and consumer electronics. We focus on the usability and
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`productivity of medical devices using, for example, image and signal processing
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`combined with intelligent computer systems to enhance practitioners’ diagnostic
`
`intuition. Our research portfolio includes low power integrated circuits and
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`systems, big data, micro electro-mechanical systems, bioelectronics, sensors, and
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`microfluidics. Specific areas of innovation include wearable, non-invasive and
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`minimally invasive optical biosensor devices, medical imaging, laboratory
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`instrumentation, and the data communication from these devices and instruments
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`to healthcare providers and caregivers. My experience with these devices is
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`directly applicable to the technology in the patent at issue.
`
`6.
`
`I am currently the Co-Director of the Device Realization Lab at the
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`Medical Electronic Device Realization Center at the Institute of Medical
`
`Engineering & Science at MIT. The Device Realization Lab designs instruments
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`and techniques to sense and control physical systems. Medical devices and
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`manufacturing inspection systems are a particular focus. We develop and combine
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`electromechanical systems, complex algorithms, and computation systems to
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`create instruments and measurement solutions for problems that are otherwise
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`intractable.
`
`7.
`
`The research of the Device Realization Lab focuses on product
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`development interests cross the boundaries of computer vision, acoustic and
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`ultrasonic imaging, large-scale computation and simulation, optimization,
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`metrology, autonomous systems, and robotics. We use computation, and computer
`
`science, as methodology for attacking complex instrumentation problems. My
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`work combines mathematical modeling, simulation, optimization, and
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`experimental observations, to develop instruments and measurement solutions.
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`8. My record of professional service includes recognitions from several
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`professional organizations in my field of expertise.
`
`9.
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`I am a named inventor on 10 issued U.S. patents. Most but not all of
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`these patents involve physiological monitoring and other measurement
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`technologies.
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`10.
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`I have published approximately 85 papers, and have received a
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`number of best paper and distinguished paper awards. A number of papers that I
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`have published relate to physiological monitoring and other measurement and
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`instrumentation technologies.
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`11.
`
`I have been retained on behalf of Apple Inc. to offer technical
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`opinions relating to U.S. Patent No. 10,470,695 (“the ’695 Patent”) and prior art
`
`references relating to its subject matter. I have reviewed the ’695 Patent and
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`relevant excerpts of the prosecution history of the ’695 Patent. I have also
`
`reviewed the following prior art references and materials, in addition to other
`
`materials I cite in my declaration:
`
` U.S. U.S. Patent No. 6,801,799 to Mendelson (“Mendelson-799” or APPLE-
`
`1004)
`
` U.S. Patent No. 8,998,815 to Venkatraman et al. (“Venkatraman” or
`
`APPLE-1005)
`
` U.S. Patent No. 6,343,223 to Chin et al. (“Chin” or APPLE-1006)
`
` Mio ALPHA Complete User Guide,
`
`https://www.medisana.com/out/pictures/media/manual/mio_alpha_user_guid
`
`e_en.pdf (2014) (APPLE-1007)
`
` DC RAINMAKER, Mio Alpha Optical Heart Rate Monitor In-Depth
`
`Review, https://www.dcrainmaker.com/2013/02/monitor-bluetooth-
`
`smartant.html (Feb. 12, 2013) (APPLE-1008)
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` Mendelson et al, A Wearable Reflectance Pulse Oximeter for Remote
`
`Physiological Monitoring, Proceedings of the 28th IEEE EMBS Annual
`
`International Conference (September 2006) (“Mendelson 2006” or APPLE-
`
`1010)
`
` U.S. Patent Application Publication No. 2007/0271009 to Conroy (“Conroy”
`
`or APPLE-1011)
`
` U.S. Patent No. 7,008,380 to Rees et al. (“Rees” or APPLE-1012)
`
` QuickSpecs; HP iPAQ Pocket PC h4150 Series (APPLE-1013)
`
`12. Counsel has informed me that I should consider these materials
`
`through the lens of one of ordinary skill in the art related to the '695 Patent at the
`
`time of the earliest possible priority date of the '695 Patent, and I have done so
`
`during my review of these materials. The application leading to the '695 Patent
`
`was filed on December 19, 2018 and claims the benefit of an earlier provisional
`
`application filed July 2, 2015 (the "Critical Date"). Counsel has informed me that
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`the Critical Date represents the earliest priority date to which the challenged claims
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`of '695 Patent are entitled, and I have therefore used that Critical Date in my
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`analysis below.
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`13.
`
`I have no financial interest in the party or in the outcome of this
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`proceeding. I am being compensated for my work as an expert on an hourly basis.
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`My compensation is not dependent on the outcome of these proceedings or the
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`content of my opinions.
`
`14.
`
`In writing this Declaration, I have considered the following: my own
`
`knowledge and experience, including my work experience in the fields of
`
`mechanical engineering, computer science, biomedical engineering, and electrical
`
`engineer; my experience in teaching those subjects; and my experience in working
`
`with others involved in those fields. In addition, I have analyzed various
`
`publications and materials, in addition to other materials I cite in my declaration.
`
`15. My opinions, as explained below, are based on my education,
`
`experience, and expertise in the fields relating to the ’695 Patent. Unless otherwise
`
`stated, my testimony below refers to the knowledge of one of ordinary skill in the
`
`fields as of the Critical Date, or before. Any figures that appear within this
`
`document have been prepared with the assistance of Counsel and reflect my
`
`understanding of the ’695 Patent and the prior art discussed below.
`
`I.
`
`Background
`16. The ’695 patent, entitled “Advanced Pulse Oximetry Sensor,” issued
`
`from an application filed on December 19, 2018, and claims priority to an earlier
`
`provisional application filed on July 2, 2015 (the Critical Date). See APPLE-1001,
`
`Face. The ’695 patent describes a “reflective pulse oximetry sensor” that emits
`
`light towards a “tissue measurement site” on a user’s body, such as their wrist, and
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`“detects the emitted light that is reflected by the tissue measurement site.” Id.,
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`10:40-45. The sensor includes “emitter” components (e.g., light emitting diodes
`
`(LEDs)) used to emit light into the tissue measurement site, and
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`“detector” components (e.g., photodiodes, phototransistors) that detect the
`
`reflected light and provide a corresponding signal to a processor or other
`
`component representing the intensity of the reflected light. Id., 10:52-64, 11:31-
`
`43. Based on fluctuations in the intensity of the reflected light, various
`
`physiological parameters (e.g., pulse rate, blood oxygen saturation) can be
`
`calculated. Id., 12:1-15. A “light blocker” separates the emitters from the
`
`detectors in order to “ensure[] that the only light detected by the detector 710 is
`
`light that is reflected from the tissue measurement site.” Id., 11:19-20.
`
`Independent claim 1 is representative:
`
`1. A wrist-worn physiological monitoring device configured
`
`for placement on a user at a tissue measurement site, the device
`
`comprising:
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`a light emission source comprising a plurality of emitters
`
`configured to irradiate the tissue measurement site by emitting
`
`light towards the tissue measurement site, the tissue
`
`measurement site being located on a wrist of the user, the
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`plurality of emitters configured to emit one or more
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`wavelengths;
`
`a plurality of detectors configured to detect the light emitted by
`
`the plurality of emitters after attenuation by a circular portion of
`
`the tissue measurement site, the plurality of detectors further
`
`configured to output at least one signal responsive to the
`
`detected light;
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`a processor configured to receive the at least one signal
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`responsive to the output and determine a physiological
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`parameter of the user; and
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`a light block forming an enclosing wall between the light
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`emission source and the plurality of detectors, the light block
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`defining the circular portion of the tissue measurement site, the
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`light emission source arranged proximate a first side of the
`
`enclosing wall and the plurality of detectors arranged proximate
`
`a second side of the enclosing wall, the first side being different
`
`than the second side,
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`wherein the enclosing wall prevents at least a portion of light
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`emitted from the light emission source from being detected by
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`the plurality of detectors without attenuation by the tissue, and
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`wherein the plurality of detectors are arranged in an array
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`having a spatial configuration corresponding to the circular
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`portion of the tissue measurement site.
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`
`
`
`II. Level of Ordinary Skill in the Art
`17. Based on the foregoing and upon my experience in this area, a person
`
`of ordinary skill in the art as of the Critical Date of the ’695 patent (a “POSITA”)
`
`would have had at least a Bachelor’s Degree in an academic area emphasizing
`
`electrical engineering, computer science, or a similar discipline, and 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. In addition, the POSITA would have had a
`
`working knowledge of physiological monitoring technologies. Superior education
`
`could compensate for a deficiency in work experience, and vice-versa.
`
`18. Based on my experiences, I have a good understanding of the
`
`capabilities of a POSITA. Indeed, I have taught, participated in organizations, and
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`worked closely with many such persons over the course of my career.
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`19.
`
`I have performed my analysis through the lens of a POSITA as of the
`
`Critical Date.
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`III.
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`Interpretations of the ’695 Patent Claims at Issue
`20.
`I understand that, for purposes of my analysis in this inter partes
`
`review proceeding, the terms appearing in the patent claims should generally be
`
`interpreted according to their “ordinary and customary meaning.” See Phillips v.
`
`AWH Corp., 415 F.3d 1303, 1312 (Fed. Cir. 2005) (en banc). I understand that
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`“the ordinary and customary meaning of a claim term is the meaning that the term
`
`would have to a person of ordinary skill in the art in question at the time of the
`
`invention.” Id. at 1313. I also understand that the person of ordinary skill in the
`
`art is deemed to read the claim term not only in the context of the particular claim
`
`in which the disputed term appears, but in the context of the entire patent,
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`including the specification. Id.
`
`IV. The combination of Mendelson-799 and Venkatraman
`A. Overview of Mendelson-799
`21. Mendelson-799 describes a reflectance pulse oximetry sensor and
`
`corresponding control circuitry to measure and “compute the [blood] oxygen
`
`saturation value, which is then presented on the display” to a user.” APPLE-1004,
`
`Abstract, 10:22-30. In more detail, Mendelson-799’s FIG. 8 (reproduced below)
`
`“illustrates a block-diagram of a pulse oximeter 20 utilizing … sensor 10.” Id.,
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`8:39-40, 10:16-17.
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`APPLE-1004, Detail of FIG. 8 (annotated).
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`22. As shown, “[t]he pulse oximeter typically includes a control unit 21,
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`which is composed of an electronic block 22 including A/D and D/A converters
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`connectable to the sensor 10, a microprocessor 24 for analyzing measured data,
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`and a display 26 for presenting measurement results.” Id., 10:16-22. “The
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`measured data (i.e., electrical output of the sensor 10 indicative of the detected
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`light) is directly processed in the block 22, and the converted signal is further
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`processed by the microprocessor 24,” which “is operated by a suitable software
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`model for analyzing the measured data and utilizing reference data (i.e., calibration
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`curve stored in a memory) to compute the oxygen saturation value, which is then
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`presented on the display 26.” Id., 10:22-30.
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`23. Mendelson-799’s FIG. 7 (reproduced below) illustrates the
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`configuration of the optical sensor 10. Id., 8:37-39.
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`APPLE-1004, Detail of FIG. 7 (annotated).
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`24. The optical sensor 10 includes “a light source 12 composed of three
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`closely spaced light emitting elements (e.g., LEDs or laser sources) 12a, 12b and
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`12c generating light of three different wavelengths,” “an array of discrete
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`detectors (e.g., photodiodes),” including “a ‘far’ detector 16 and a ‘near’ detector
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`18, arranged in two concentric ring-like arrangements … surrounding the
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`light emitting elements; and a light shield 14.”1 Id., 9:22-33. “All these
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`elements are accommodated in a sensor housing 17,” with “[t]he light shield 14
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`[being] positioned between the photodiodes and the light emitting elements” so as
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`
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`1 All emphasis added unless otherwise indicated.
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`to “prevent[] direct optical coupling between them, thereby maximizing the
`
`fraction of backscattered light passing through the arterially perfused vascular
`
`tissue in the detected light.” Id., 9:33-40. “This arrangement allows for measuring
`
`SaO2 from multiple convenient locations on the body (e.g., the head, torso, or
`
`upper limbs), where convenient transmission mode measurements are not
`
`feasible.” Id., 2:14-28; see also Id., 3:19-28 (“measurements are made from
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`sensors attached to the forehead, chest, or the buttock area”), 3:35-44, 4:29-32
`
`(“forehead, forearm and the calf on humans”).
`
`25.
`
`In sum, Mendelson-799 depicts and describes a physiological
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`measurement and monitoring device configured to measure blood oxygen
`
`saturation of a user at an external tissue measurement site. Id., Abstract (“The
`
`sensor includes sensor housing, a source of radiation coupled to the housing, and a
`
`detector assembly coupled to the housing … the detector assembly is adapted to
`
`detect reflected radiation at least one predetermined frequency and to generate
`
`respective signals … used to determine the parameter of the blood”), 7:25-8:13
`
`(“There is thus provided ... a sensor for use in an optical measurement device for
`
`non-invasive measurements of blood parameters”), 2:14-28 (“This arrangement
`
`allows for measuring SaO2 from multiple convenient locations on the body (e.g.,
`
`the head, torso, or upper limbs), where convenient transmission mode
`
`measurements are not feasible”), 8:37-41, 9:22-40, 10:16-30, FIGS. 7, 8.
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`14
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`B. Overview of Venkatraman
`26. Venkatraman teaches a portable biometric monitoring device with a
`
`touchscreen display that can be worn on the wrist like a watch. APPLE-1005,
`
`12:16-21, 15:19-26, 52:23-53:18. In particular, Venkatraman describes a
`
`“biometric monitoring device[] ... adapted to be worn or carried on the body of a
`
`user ... including [an] optical heart rate monitor” designed to “be a wrist-worn or
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`arm-mounted accessory such as a watch or bracelet.” APPLE-1005, 37:29-33.
`
`Venkatraman’s monitoring device is “small in size so as to be unobtrusive for the
`
`wearer” and “designed to be able to be worn without discomfort for long periods of
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`time and to not interfere with normal daily activity.” APPLE-1005, 14:28-36.
`
`Venkatraman device also includes a digital display with “uses capacitive touch
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`detection,” as shown in FIG. 6B, to display data acquired or stored locally on the
`
`wristwatch. APPLE-1005, 53:19-55:51.
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`APPLE-1005, Detail of FIGS. 6A, 6B (annotated).
`
`
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`Wrist-
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`worn
`
`
`APPLE-1005, Detail of FIG. 7 (annotated).
`
`27. Like Mendelson-799, Venkatraman’s biometric monitoring device
`
`employs LEDs and photo detectors to obtain user data such as heart rate and blood
`
`oxygen saturation of a user. APPLE-1005, 1:54-:57 (“The disclosure also
`
`provides methods for operating the LED and photo detector of heart rate monitors
`
`to obtain accurate reading of heart rate tailored for different user characteristics
`
`such as skin colors.), see also 33:14-20 (“optical sensors may sample, acquire
`
`and/or detect physiological data which may then be processed or analyzed . . . to
`
`obtain data that is representative of for example, a user's heart rate, respiration,
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`heart rate variability, oxygen Saturation (SpO), blood volume, blood glucose,
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`skin moisture, and/or skin pigmentation level.”), see also 17:1-38, 19:32-37.
`
`Venkatraman’s biometric monitoring device uses emitters (LEDs) to emit radiation
`
`onto the user’s body, detectors to receive the reflected radiation from the user’s
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`body, and an optical wall/light shield between the emitters and detectors to prevent
`
`the detectors from detecting radiation directly from the emitters. APPLE-1005,
`
`33:4-20, 36:38-56, FIGS. 3A, 3B (reproduced below). Venkatraman’s monitoring
`
`device also includes a light concentrator in the form of a lens to facilitate light
`
`collection and minimize losses. Id., 34:5-20 (“the light-transmissive structures
`
`may employ a material and/or optical design to facilitate low light loss (for
`
`example, the light-transmissive structures may include a lens to facilitate light
`
`collection …)”).
`
`
`
`Emitters
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`Light
`
`
`
`APPLE-1005, FIG. 3A, 3B (annotated).
`
`28. The sensor in the biometric monitoring device that performs the
`
`measurements is placed on the bottom side of the device facing the wrist, as shown
`
`in FIGS. 2B and 2C. APPLE-1005, 15:35-54.
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`
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`APPLE-1005, FIGS. 2B (left), 2C (right).
`
`C. Overview of the combination
`29. A POSITA would have found it obvious to modify Mendelson-799’s
`
`pulse oximeter to be wrist-worn, and to include a touch screen, based on the
`
`teachings of Venkatraman. APPLE-1004, 2:14-28, 10:16-30, 9:22-40; APPLE-
`
`1005, 33:4-20, 36:38-37:40. Additionally, in light of Venkatraman’s teaching a
`
`POSITA would have found it obvious to incorporate the “lens to facilitate light
`
`collection” of Venkatraman as a light concentrator in the optical oximetery sensor
`
`taught by Mendelson-799. APPLE-1004, 9:22-40, FIG. 7; APPLE-1005, 34:5-20.
`
`D. Reasons to combine Mendelson-799 and Venkatraman
`30. A POSITA would have found it obvious to combine the teachings of
`
`Mendelson-799 and Venkatraman in the manner described above because doing so
`
`would have amounted to nothing more than the use of a known technique to
`
`improve similar devices in the same way and combining prior art elements
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`according to known methods to yield predictable results. Mendelson-799 and
`
`Venkatraman are both related to obtaining physiological parameters by emitting
`
`radiation (e.g., visible or infrared light) and detecting reflected radiation from
`
`human tissue. APPLE-1004, 2:14-28, 10:16-30, 9:22-40; APPLE-1005, 33:4-20,
`
`36:38-37:40, FIGS. 3A, 3B. Implementing Mendelson-799’s sensor to be wrist-
`
`worn like Venkatraman’s biometric monitoring device would minimize discomfort
`
`and interference in daily activities caused by the sensor, which a POSITA would
`
`have recognized as beneficial. APPLE-1005, 14:28-36. Integrating Mendelson-
`
`799’s sensor 10 and control unit 21 into a single, wrist-worn device, such as that
`
`taught by Venkatraman, would have resulted in a simpler, less-cluttered
`
`configuration with fewer devices and external connections, which can be
`
`cumbersome to the user. APPLE-1005, 50:36-51:45. The POSITA would have
`
`understood that by integrating the components into a single device, issues with
`
`poorly connected wires between the sensors and processing units can be mitigated,
`
`and the components and connections between them can be protected within the
`
`housing of the wrist-worn device, thereby resulting in a device that is more robust
`
`and resistant to damage. See, e.g., APPLE-1005, 50-36-51:61. For example, in the
`
`combination, components of Mendelson-799’s pulse oximeter (e.g., processors,
`
`emitters, detectors, etc.) are implemented by electronic circuits on discrete chips or
`
`a packaged chip connected to or integrated with a PCB, as shown in
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`Venkatraman’s FIGS. 2C, 3A, and 3B. APPLE-1005, 50:36-51:45, FIGS. 2C, 3A,
`
`3B. Thus, a POSITA would have been motivated to perform the combination, for
`
`example, because the resulting Mendelson-799-Venkatraman wrist-worn optical
`
`sensor would (i) make it easier and more convenient for the user to monitor
`
`physiological data (e.g., heart rate, oxygen level) throughout the day, (ii) minimize
`
`clutter caused by multiple devices, and (iii) be more robust and resistant to
`
`damage.
`
`31. Additionally, it would have been obvious to a POSITA to implement a
`
`touch screen in the Mendelson-799-Venkatraman wrist-worn physiological
`
`monitoring device as doing so would allow a user to easily navigate a display and
`
`provide inputs such as activating functions in a convenient manner. See also
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`APPLE-1010, 4. By implementing a touch screen, additional input devices such as
`
`a microphone for audio input or physical buttons implemented on device housing
`
`or in a connected computer can be avoided, thereby conserving space and
`
`providing a clutter free and user-friendly environment to use the physiological
`
`monitoring device. Consequently, implementing the display of the Mendelson-
`
`799-Venkatraman device as a touch screen is nothing more than the straight
`
`forward use of a known technique to improve similar devices in the same way and
`
`a straight forward substitution of prior art elements according to known methods to
`
`yield predictable results.
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`32. A POSITA would have had a reasonable expectation of success in
`
`implementing this combination at least because miniaturization techniques (like
`
`those employed to configure Mendelson-799’s device to be wrist-worn) were well-
`
`known and widely utilized in the art during the relevant timeframe. Indeed, during
`
`the 11 year gap in the filing dates of Venkatraman and Mendelson-799 the size of
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`circuits decreased significantly and the industry followed the trend set by Moore’s
`
`law which indicates at least 10x greater density. Venkatraman itself teaches a
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`wrist-worn device that incorporates emitters, detectors, and processors in
`
`configurations similar to the proposed combination. APPLE-1005, 50:36-51:61;
`
`33.
`
`In the combined device, the operations of Mendelson-799’s LEDs,
`
`photodetectors, light shield, and data processing are unchanged. Indeed, the
`
`elements of the combined system would each perform similar functions in similar
`
`ways to those taught in Mendelson-799 and Venkatraman. For example, the sensor
`
`would still be performing the same sensor operations, the processor would still be
`
`performing the same processing operations, and the display would still be
`
`performing the same display operations. Accordingly, the Mendelson-799-
`
`Venkatraman combination would have been predictable to a POSITA, and the
`
`POSITA would have had a reasonable expectation of success in performing the
`
`combination.
`
`21
`
`

`

`E. Analysis
`1.
`Claim 1
`In the combination, Mendelson-799 describes a pulse oximeter device
`
`34.
`
`that uses a sensor placed on user tissue to obtain physiological measurements of
`
`the user. APPLE-1004, 10:15-30 (“FIG. 8 illustrates a block diagram of a pulse
`
`oximeter 20 utilizing ... sensor 10”); Abstract (“sensor for use in an optical
`
`measurement device and a method for non-invasive measurement of a blood
`
`parameter”); 5:49-59, 8:37-41, 9:22-40 (“Referring to FIG. 7, there is illustrated an
`
`optical sensor 10 … aimed at minimizing some of the measurement inaccuracies in
`
`a reflectance pulse oximeter”). The sensor is configured for placement on a user at
`
`a tissue measurement site and includes a “sensor housing, a source of radiation
`
`coupled to the housing, and a detector assembly coupled to the housing[.]” Id.;
`
`Abstract. “[T]he detector assembly is adapted to detect reflected radiation [from]
`
`at least one predetermined frequency and to generate respective signals … used to
`
`determine the parameter of the blood.” Id., Abstract. This “reflection
`
`mode…arrangement allows for measuring SaO2 [oxygen saturation]from multiple
`
`convenient locations on the body (e.g., the head, torso, or upper limbs), where
`
`convenient transmission mode measurements are not feasible.” APPLE-1004,
`
`2:14-21, 10:16-30, FIGS. 7, 8.
`
`22
`
`

`

`35. Also in the combination, Venkatraman teaches that a portable
`
`biometric monitoring device can be wrist-worn, as shown in FIGS. 6A, 6B, and 7
`
`(reproduced below). APPLE-1005, 12:16-21, 15:19-26, 52:23-53:18.
`
`APPLE-1005, FIGS. 6A, 6B (annotated).
`
`
`
`
`
`Wrist-worn
`monitoring device
`
`
`
`APPLE-1005, Detail of FIG. 7 (annotated).
`
`36. Venkatraman explains that “[b]iometric monitoring devices … are
`
`typically small in size so as to be unobtrusive for the wearer.” APPLE-1005,
`
`14:28-30. “Biometric monitoring devices are typically designed to be able to be
`
`23
`
`

`

`worn without discomfort for long periods of time and to not interfere with normal
`
`daily activity.” APPLE-1005, 14:30-36. Venkatraman also teaches the use of a
`
`digital display, as shown in FIG. 6B, to display data acquired or stored locally on
`
`the device. APPLE-1005, 53:19-55:51.
`
`37.
`
`In the combination, Mendelson-799 describes a noninvasive optical
`
`physiological sensor that includes “a light source 12 composed of three closely
`
`spaced light emitting elements (e.g., LEDs or laser sources) 12a, 12b and 12c
`
`generating light of three different wavelengths, respectively ….” APPLE-1004,
`
`Abstract, 2:65-3:15, 7:25-8:13, 8:37-41, 9:22-40, 10:16-30, FIGS. 7, 8.
`
`38.
`
`In more detail, the light emitting elements 12a, 12b, and 12c
`
`illustrated in Mendelson-799’s FIG. 7 (reproduced below) are “adapted to emit
`
`radiation at predetermined frequencies” onto the tissue measurement site, and the
`
`“detector assembly is adapted to detect reflected radiation … and to generate
`
`respective signals” that “are used to determine the parameter of the blood.” Id.,
`
`Abstract, 9:22-40, FIG. 7; see also APPLE-1004, 7:25-47, 9:42-10:15 (noting that
`
`“[t]he actual numbers of wavelengths used as a light source and the number of
`
`photodetectors in each ring are not limited and depend only on the electronic
`
`circuitry inside the oximeter”). The depicted arrangement features a light shield 14
`
`“positioned between the photodiodes and the light emitting elements” to “prevent[]
`
`direct optical coupling between them, thereby maximizing the fraction of
`
`24
`
`

`

`backscattered light passing through the arterially perfused vascular tissue in the
`
`detected light.” APPLE-1004, 9:33-40.
`
`APPLE-1004, Detail of FIG. 7 (annotated)
`
`
`
`39.
`
`In the combination, Venkatraman teaches a “biometric monitoring
`
`device[] ... adapted to be worn or carried on the body of a user ... including [an]
`
`optical heart rate monitor” designed to “be a wrist-worn or arm-mounted accessory
`
`such as a watch or bracelet” APPLE-1005, 37:29-33. As previously discussed, it
`
`would have been obvious to a POSITA to combine Mendelson-799 with
`
`Venkatraman such that the tissue measurement site would be located on a wrist of
`
`the user. APPLE-1005, 12:16-21, 14:28-36, 15:19-26, FIGS. 6A, 6B, 7.
`
`25
`
`

`

`APPLE-1004, Detail of FIG. 7 (annotated).
`
`
`
`40. Also in the combination, Mendelson-799 teaches that its light emitting
`
`elements (e.g., LEDs) 12a, 12b, 12c (see FIG. 7 above) generate light of three
`
`different wavelengths. APPLE-1004, 9:22-40. In Mendelson-799, “two
`
`measurement sessions typically [are] carried out in pulse oximetry based on
`
`measurements with two wavelengths centered around the peak emission values of
`
`660 nm (red spectrum) and 940 nmi-20 nm (IR spectrum), [and] one additional
`
`measurement session is carried out with an additional wavelength.” APPLE-1004,
`
`6:44-50; see also 6:50-58 (“In a preferred embodiment the use of at least three
`
`wavelengths enables the calculation of an at least one additional ratio formed by
`
`the combination of the two IR wavelengths”), 7:4-24, 7:42-46, 8:1-5, 9: 4 (“dual-
`
`wavelength reflection type pulse oximeter”), 9:40-47 (“more than three
`
`wavelengths can be utilized in the sensor”), 9:62-67.
`
`26
`
`

`

`41.
`
`In the combination, Mendelson-799 depicts and describes a
`
`noninvasive optical sensor that includes “an array of discrete detectors (e.g.,
`
`photodiodes),” including “a ‘far’ detector 16 and a ‘near’ detector 18, arranged in
`
`two concentric ring-like arrangements … surrounding “light emitting elements
`
`….” APPLE-1004, Abstract, 7:25-8:13, 8:37-41, 9:22-10:30, FIGS. 7, 8. The
`
`arrangement of a pair of detectors in different portions of the two concentric ring-
`
`like arrangements results in twelve detectors being used in Mendelson-799’s
`
`device, as shown in FIG. 7 below.
`
`APPLE-1004, Detail of FIG. 7 (annotated).
`
`
`
`42.
`
`In more detail, each of the discrete photodiodes included in the
`
`detector assembly illustrated in Mendelson-799’s FIG. 7 are “adapted to detect
`
`reflected radiation … and to generate respective signals” that “are used to
`
`determine the parameter of the blood.” APPLE-1004, Abstract, 9:22-40, FIG. 7.
`
`In the depicted embodiment, the “array of discrete detector

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