Filed: July 20, 2021
`
`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
`
`DECLARATION OF VIJAY K. MADISETTI, PH.D.
`
`MASIMO 2001
`Apple v. Masimo
`IPR2020-01526
`
`
`
`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
`
`DECLARATION OF VIJAY K. MADISETTI, PH.D.
`
`MASIMO 2001
`Apple v. Masimo
`IPR2020-01526
`
`
`
`TABLE OF CONTENTS
`
`Page No.
`
`I.
`
`QUALIFICATIONS ........................................................................................ 1
`
`II. MATERIALS CONSIDERED ........................................................................ 8
`
`III. UNDERSTANDING OF PATENT LAW .................................................... 10
`
`A.
`
`B.
`
`C.
`
`Level Of Ordinary Skill In The Art ..................................................... 10
`
`Claim Construction ............................................................................. 11
`
`Obviousness ......................................................................................... 12
`
`IV. BACKGROUND ........................................................................................... 13
`
`A.
`
`B.
`
`C.
`
`D.
`
`The Importance of Pulse Oximeters .................................................... 13
`
`How Oximetry Works ......................................................................... 14
`
`The ’994 Patent ................................................................................... 17
`
`Introduction to Claim 15 of the ’994 Patent ........................................ 19
`
`V.
`
`CLAIM CONSTRUCTION .......................................................................... 19
`
`VI. LEVEL OF ORDINARY SKILL IN THE ART ........................................... 25
`
`VII. THE PETITION’S PROPOSED GROUNDS ............................................... 26
`
`VIII. OVERVIEW OF ASSERTED REFERENCES ............................................ 27
`
`A. Diab (EX1006) .................................................................................... 27
`
`B.
`
`Benjamin (EX1007) ............................................................................ 30
`
`C. Melby (EX1008) .................................................................................. 32
`
`-i-
`
`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`D. Webster (EX1010) ............................................................................... 33
`
`E.
`
`Fine (EX1009) ..................................................................................... 35
`
`IX. THE PETITION’S PROPOSED COMBINATIONS .................................... 38
`
`A. GROUND 1: THE COMBINATION OF DIAB,
`BENJAMIN, AND MELBY DOES NOT TEACH
`THE CLAIMED INVENTION ........................................................... 38
`
`1.
`
`2.
`
`3.
`
`4.
`
`Apple’s combination would undermine Diab’s
`invention .................................................................................... 38
`
`Apple’s unexplained modification would cause
`Diab to perform worse .............................................................. 44
`
`The proposed modifications would not have
`yielded predictable results ......................................................... 48
`
`Apple fails to provide a credible motivation to
`add louvers ................................................................................ 50
`
`B.
`
`GROUND 2: THE COMBINATION OF WEBSTER
`AND MELBY DOES NOT TEACH THE CLAIMED
`INVENTION ....................................................................................... 53
`
`1.
`
`Apple conflates Webster’s wavelength filter
`and Webster’s light impervious barriers ................................... 53
`
`2. Melby does not disclose a plurality of louvers
`positioned over a light sensitive detector .................................. 57
`
`3.
`
`A POSITA would not have been motivated to
`modify Webster to include Melby’s light
`control film over the photodiode .............................................. 57
`
`-ii-
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`
`
`TABLE OF CONTENTS
`(cont’d)
`
`Page No.
`
`C.
`
`GROUND 3: FINE DOES NOT TEACH THE
`CLAIMED INVENTION .................................................................... 60
`
`1.
`
`2.
`
`A POSITA would not have considered Fine ............................ 60
`
`Optical fibers are not louvers .................................................... 61
`
`D. GROUND 4: THE COMBINATION OF FINE,
`BENJAMIN, AND MELBY DOES NOT TEACH
`THE CLAIMED INVENTION ........................................................... 65
`
`1.
`
`2.
`
`Dr. Anthony fails to explain how a light control
`Film could be incorporated into Fine ........................................ 65
`
`Apple’s motivations to combine Fine,
`Benjamin, and Melby are conclusory and
`unsupported ............................................................................... 73
`
`X. OATH ............................................................................................................ 75
`
`
`
`
`
`
`
`-iii-
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`IPR2020-01526
`Apple Inc. v. Masimo Corporation
`
`I, Vijay K Madisetti, Ph.D, declare as follows:
`
`1.
`
`I have been retained by counsel for Patent Owner Masimo Corporation
`
`(“Masimo”) as an independent expert witness in this proceeding. I have been asked
`
`to provide my opinions regarding the Petition in this action and the declaration
`
`offered by Brian W. Anthony, Ph.D., (EX1003) challenging the patentability of
`
`Claim 15 of U.S. Patent No. 6,771,994 (“the ’994 Patent”). I am being compensated
`
`at my usual and customary rate for the time I spend working on this proceeding, and
`
`my compensation is not affected by its outcome.
`
`I.
`QUALIFICATIONS
`2. My qualifications are set forth in my curriculum vitae, a copy of which
`
`is included as Exhibit 2002. A summary of my qualifications follows.
`
`3.
`
`I am a professor in Electrical and Computer Engineering at the Georgia
`
`Institute of Technology (“Georgia Tech”). I have worked in the area of digital signal
`
`processing, wireless communications, computer engineering, integrated circuit
`
`design, and software engineering for over 25 years, and have authored, co-authored,
`
`or edited several books and numerous peer-reviewed technical papers in these area.
`
`4.
`
`I obtained my Ph.D. in Electrical Engineering and Computer Science at
`
`the University of California, Berkeley, in 1989. While there, I received the Demetri
`
`Angelakos Outstanding Graduate Student Award and the IEEE/ACM Ira M. Kay
`
`Memorial Paper Price.
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`5.
`
`I joined Georgia Tech in the Fall of 1989 and am now a tenured full
`
`professor in Electrical and Computer Engineering. Among other things, I have been
`
`active in the areas of digital signal processing, wireless communications, integrated
`
`circuit design (analog & digital), system-level design methodologies and tools, and
`
`software engineering. I have been the principal investigator (“PI”) or co-PI in
`
`several active research programs in these areas, including DARPA’s Rapid
`
`Prototyping of Application Specific Signal Processors, the State of Georgia’s
`
`Yamacraw Initiative, the United States Army’s Federated Sensors Laboratory
`
`Program, and the United States Air Force Electronics Parts Obsolescence Initiative.
`
`I have received an IBM Faculty Award and NSF’s Research Initiation Award. I
`
`have been awarded the 2006 Frederick Emmons Terman Medal by the American
`
`Society of Engineering Education for contributions to Electrical Engineering,
`
`including authoring a widely used textbook in the design of VLSI digital signal
`
`processors.
`
`6.
`
`During the past 20 years at Georgia Tech, I have created and taught
`
`undergraduate and graduate courses in hardware and software design for signal
`
`processing, computer engineering (software and hardware systems), computer
`
`engineering and wireless communication circuits.
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`7.
`
`I have been involved in research and technology in the area of digital
`
`signal processing since the late 1980s, and I am the Editor-in-Chief of the CRC
`
`Press’s 3-volume Digital Signal Processing Handbook (1998, 2010).
`
`8.
`
`I have founded three companies in the areas of signal processing,
`
`embedded software, military chipsets involving imaging technology, and software
`
`for computing and communications systems. I have supervised Ph.D. dissertations
`
`of over twenty engineers in the areas of computer engineering, signal processing,
`
`communications, rapid prototyping, and system-level design methodology.
`
`9.
`
`I have designed several specialized computer and communication
`
`systems over the past two decades at Georgia Tech for tasks such as wireless audio
`
`and video processing and protocol processing for portable platforms, such as cell
`
`phones and PDAs. I have designed systems that are efficient in view of performance,
`
`size, weight, area, and thermal considerations. I have developed courses and classes
`
`for industry on these topics, and many of my lectures in advanced computer system
`
`design, developed under the sponsorship of the United States Department of Defense
`
`in the late 1990s, are available for educational use at http://www.eda.org/rassp and
`
`have been used by several U.S. and international universities as part of their course
`
`work. Some of my recent publications in the area of design of computer engineering
`
`and wireless communications systems and associated protocols are listed in Exhibit
`
`2005.
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`10.
`
`In the mid 2006-2007 timeframe, I collaborated with Professor John
`
`Scharf and his colleagues at Emory Healthcare system in developing FFT-based
`
`pulse oximetry system prototypes on FPGAs, which extended technologies
`
`developed by Prof. Scharf and his colleagues from the 1996 time frame (See T.
`
`Rusch, R. Sankar, J. Scharf, “Signal Processing Methods for Pulse Oximetry”,
`
`Comput. Bio. Med, Vol. 26, No. 2, 1996). Some of my more recent publications in
`
`the area of biological signal processing and bioinformatics are listed in my CV and
`
`include, A. Bahga, V. Madisetti, “Healthcare Data Integration and Informatics in the
`
`Cloud”, IEEE Computer, Vol. 48, Issue 2, 2015, and “Cloud-Based Information
`
`Integration Informatics Framework for Healthcare Applications”, IEEE Computer,
`
`Issue 99, 2013. In addition to my signal processing experience specific to pulse
`
`oximetry, I also have experience in developing systems for other physiological
`
`signals. Beginning in the early 1990s, I worked, in particular, with ECG/EKG
`
`signals, and, in general, with biomedical signals and systems.
`
`11.
`
`In addition to my signal processing experience specific to pulse
`
`oximetry, I also have experience in developing algorithms and systems for other
`
`physiological signals. I worked with ECG/EKG signals in particular, and
`
`biomedical signals and systems in general, beginning in the early 1990s. In
`
`particular, I worked with graduate student Dr. Shahram Famorzadeh, in 1990 and
`
`1991, to analyze and apply pattern recognition (a category of signal processing
`
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`algorithms that is based on correlation with a set of templates) to ECG/EKG
`
`waveforms to identify physiological conditions.
`
`12.
`
`I have experience with biomedical signals and devices in the field of
`
`speech and image processing since the late 1980s. I worked on deconvolution
`
`algorithms to recover the state of the system based on observed measurements of the
`
`physiological signals in the 1993-1998 time-frame. These signal processing
`
`techniques can be applied to pulse oximetry signals, and I have been working with
`
`these techniques since the mid-1980s.
`
`13.
`
`I have studied, researched and published in the area of adaptive filter
`
`signal processing for noise reduction and signal prediction, using correlation-based
`
`approaches since the mid-1980s, both in the time-domain and frequency domain,
`
`and also to ray-tracing applications, such as Seismic Migration for oil and shale gas
`
`exploration. See for instance, V. Madisetti & D. Messerschmitt, Dynamically
`
`Reduced Complexity Implementation of Echo Cancellers, IEEE International
`
`Conference on Speech, Acoustics and Signal Processing, ICASSP 1986, Tokyo,
`
`Japan, and M. Romdhane and V. Madisetti, “All-Digital Oversampled Front-End
`
`Sensors” IEEE Signal Processing Letters, Vol 3, Issue 2, 1996, and “LMSGEN: A
`
`Prototyping Environment for Programmable Adaptive Digital Filters in VLSI”,
`
`VLSI Signal processing, pp. 33-42, 1994.
`
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`
`14. Deconvolution of symmetric (seismic) and asymmetric (pulse
`
`oximetry) signals has gained much importance in the past two decades, and some of
`
`my early work on “Homomorphic Deconvolution of Bandpass Signals” in IEEE
`
`Transactions on Signal Processing, October 1997, established several new methods
`
`for deconvolution of such signals that had several advantages of robustness,
`
`increased accuracy, and simplicity.
`
`15.
`
`In the past decade I have authored several peer-reviewed papers in the
`
`area of computer systems, instruments, and software design, and these include:
`
`
`
`
`
`
`
`
`
`
`
`V. Madisetti, et al., “The Georgia Tech Digital Signal Multiprocessor,
`
`IEEE Transactions on Signal Processing, Vol. 41, No. 7, July 1993.
`
`V. Madisetti et al., “Rapid Prototyping on the Georgia Tech Digital
`
`Signal Multiprocessor”, IEEE Transactions on Signal Processing, Vol.
`
`42, March 1994.
`
`V. Madisetti, “Reengineering legacy embedded systems”, IEEE Design
`
`& Test of Computers, Vol. 16, Vol. 2, 1999.
`
`V. Madisetti et al., “Virtual Prototyping of Embedded Microcontroller-
`
`based DSP Systems”, IEEE Micro, Vol. 15, Issue 5, 1995.
`
`V. Madisetti, et al., “Incorporating Cost Modeling in Embedded-
`
`System Design”, IEEE Design & Test of Computers, Vol. 14, Issue 3,
`
`1997.
`
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`
`
`V. Madisetti, et al., “Conceptual Prototyping of Scalable Embedded
`
`DSP Systems”, IEEE Design & Test of Computers, Vol. 13, Issue 3,
`
`1996.
`
`
`
`
`
`V. Madisetti, Electronic System, Platform & Package Codesign,” IEEE
`
`Design & Test of Computers, Vol. 23, Issue 3, June 2006.
`
`V. Madisetti, et al., “A Dynamic Resource Management and
`
`Scheduling Environment
`
`for Embedded Multimedia
`
`and
`
`Communications Platforms”, IEEE Embedded Systems Letters, Vol. 3,
`
`Issue 1, 2011.
`
`16.
`
`I have been active in the areas of signal processing systems and mobile
`
`device communication systems for several years, and some of my publications in
`
`this area include “Frequency Dependent Space-Interleaving of MIMO OFDM
`
`Systems” Proc. of IEEE Radio and Wireless Conference (RAWCON ’03), 2003,
`
`“Embedded Alamouti Space Time Codes for High Rate and Low Decoding
`
`Complexity”, Proc. IEEE Asilomar Conf. on Signals, Systems, and Computers,
`
`2008; and “Asymmetric Golden Codes for Fast Decoding in Time Varying
`
`Channels”, Wireless Personal Communications (2011).
`
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`II. MATERIALS CONSIDERED
`17. Below is a listing of documents and materials that I considered and
`
`reviewed in connection with providing this declaration. In forming my opinions, I
`
`considered those materials as well as anything cited or discussed in this declaration.
`
`Exhibit
`
`Description
`
`1001
`1002
`1003
`1006
`1007
`1008
`1009
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1034
`
`U.S. Patent No. 6,771,994
`File History for U.S. Patent No. 6,771,994
`Declaration of Dr. Anthony
`U.S. Patent No. 5,638,818 (“Diab”)
`U.S. Patent No. 4,015,595 (“Benjamin”)
`U.S. Patent No. 5,254,388 (“Melby”)
`WO Pub. No. 1996/41566 (“Fine”)
`Excerpts from Design of Pulse Oximeters, J.G. Webster;
`Institution of Physics Publishing, 1997 (“Webster”)
`Tremper, Pulse Oximetry, Anesthesiology, The Journal of the
`American Society of Anesthesiologists, Inc., Vol. 70, No. 1
`(January 1989)
`Mendelson, Skin Reflectance Pulse Oximetry: In Vivo
`Measurements from the Forearm and Calf, Journal of Clinical
`Monitoring, Vol. 7, No. 1 (January 1991)
`Excerpts
`from Bronzino, The Biomedical Engineering
`Handbook, CRC Press, Inc. (1995)
`Konig, Reflectance Pulse Oximetry – Principles and Obstetric
`Application
`in
`the Zurich System, Journal of Clinical
`Monitoring, Vol. 14, No. 6 (August 1998)
`Joseph Guzman, “Fauci says second wave of coronavirus is
`‘inevitable’”, TheHill.com (Apr. 29, 2020), available at:
`https://thehill.com/changing-
`america/resilience/naturaldisasters/495211-fauci-says-second-
`wave-of-coronavirus-is
`
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`
`Exhibit
`
`Description
`
`1035
`
`2004
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`2010
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`in Los Angeles County,”
`the coronavirus
`“Tracking
`LATimes.com
`(Aug.
`20,
`2020),
`available
`at
`https://www.latimes.com/projects/california-coronavirus-
`casestracking-outbreak/los-angeles-county/
`“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
`Tamura et al., “Wearable Photoplethysmographic Sensors—
`Past and Present,” Electronics 3:282-302 (2014)
`U.S. Patent No. 4,700,708
`for Automotive
`Verploegh,
`“Light Control Systems
`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
`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
`U.S. Patent No. 5,099,842
`Hecht, Understanding Fiber Optics, Laser Light Press (5th ed.
`2015)
`Definition of “louver,” lexico.com (powered by Oxford)
`
`-9-
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`Exhibit
`
`Description
`
`Paper 2
`Paper 7
`
`Petition for Inter Partes Review IPR2020-01526
`Decision Granting Institution of Inter Partes Review IPR2020-
`01526
`
`
`
`III. UNDERSTANDING OF PATENT LAW
`I am not an attorney and will not be offering legal conclusions.
`
`18.
`
`However, I have been informed of several principles concerning the legal issues
`
`relevant to analyzing the challenges to the claims of the ’994 Patent, and I used these
`
`principles in arriving at my conclusions.
`
`A. Level Of Ordinary Skill In The Art
`19.
`I understand that certain issues in an IPR, such as claim construction
`
`and whether a claim is invalid as obvious, are assessed from the view of a
`
`hypothetical person of ordinary skill in the relevant art at the time of the invention. I
`
`understand there are multiple factors relevant to determining the level of ordinary
`
`skill in the art, including (1) the level of education and experience of persons working
`
`in the field at the time of the invention; (2) the sophistication of the technology; (3)
`
`the types of problems encountered in the field; and (4) the prior art solutions to those
`
`problems. I understand that this hypothetical person of ordinary skill is presumed to
`
`have had knowledge from the teachings of the prior art.
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`20.
`
`I understand that Apple Inc. (“Apple” or “Petitioner”) and its Declarant
`
`Dr. Anthony have set forth the following definition for a person of ordinary skill in
`
`the art (“POSITA”):
`
`[S]omeone with a working knowledge of physiological monitoring
`
`technologies. The person would have had a Bachelor of Science degree in an
`
`academic discipline emphasizing the design of electrical, computer, or
`
`software technologies, in combination with training or at least one to two years
`
`of related work experience with capture and processing of data or information,
`
`including but not limited to physiological monitoring technologies.
`
`EX1003 ¶ 36. Dr. Anthony further asserts: “Alternatively, the person could have
`
`also had a Master of Science degree in a relevant academic discipline with less than
`
`a year of related work experience in the same discipline.” Id.
`
`B. Claim Construction
`21.
`I understand that claim construction in an IPR is a legal question for the
`
`Board to decide. I also understand, however, that in construing claim terms, the
`
`Board asks what the terms would mean to a person of ordinary skill in the relevant
`
`art in view of the disclosures in the patent and the prosecution history of the patent.
`
`I understand that the Board may also consider external evidence, such as dictionaries.
`
`In general, however, I understand that claim terms are given the ordinary and
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`customary meaning one of ordinary skill in the relevant art would apply to them in
`
`the context of the patent at the time the patent was filed.
`
`C. Obviousness
`22.
`I understand that a patent claim is invalid under the patent law,
`
`35 U.S.C. § 103, if, at the time the claimed invention was made, the differences
`
`between the prior art and the claimed invention as a whole would have been obvious
`
`to a person of ordinary skill in the art. I understand that the following facts are
`
`considered in determining whether a claimed invention is invalid as obvious in view
`
`of the prior art: (1) the scope and content of the prior art; (2) the level of ordinary
`
`skill in the art; and (3) the differences, if any, between the claimed invention and the
`
`prior art.
`
`23.
`
`I also understand there are additional considerations that may be used
`
`in evaluating whether a claimed invention is obvious. These include whether the
`
`claimed invention was the result of (a) a teaching, suggestion, or motivation in the
`
`prior art that would have led one of ordinary skill to modify the prior art to arrive at
`
`the claimed invention; (b) a combination of prior art elements combined according to
`
`known methods to yield predictable results; (c) a simple substitution of one known
`
`element for another to obtain a predicable result; (d) the use of a known technique to
`
`improve similar things in the same way; (e) applying a known technique to a known
`
`thing ready for improvement to yield predictable results; (f) choosing from a finite
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`number of identified, predictable solutions, with a reasonable expectation of success;
`
`(g) known work in one field of endeavor prompting variations of it for use in either
`
`the same filed or a different one based on design incentives or other market forces if
`
`the variations are predictable to one of ordinary skill in the art.
`
`24.
`
`25.
`
`I have applied this understanding in my analysis.
`
`I understand that Dr. Anthony carried out his analysis of patentability
`
`as of June 18, 1999. EX1003 ¶¶12, 17. I likewise carry out my analysis of
`
`patentability as of June 18, 1999. I do not offer any opinions regarding priority in
`
`this declaration.
`
`IV. BACKGROUND
`A. The Importance of Pulse Oximeters
`26. Once a person loses his or her oxygen supply, referred to as hypoxia, a
`
`caregiver has only a few minutes to prevent brain damage, heart failure and death.
`
`EX1010 at 14; EX1013 at 1346; EX1001 at 1:24-28. Accordingly, there is a need to
`
`quickly and accurately determine the amount of oxygen in blood. EX1013 at 1346;
`
`EX1001 at 1:24-28. A type of physiological monitoring device, called a pulse
`
`oximeter, readily detects changes in a person’s oxygen saturation, which is an
`
`indicator of the person’s oxygen supply. EX1001 at 1:29-31. For at least this
`
`relationship to oxygen supply, use of pulse oximeters are considered a standard of
`
`care and an essential diagnostic tool in the U.S. for anesthetics, emergency patients,
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`urgent care settings including first responders and ambulance care, surgical
`
`environments, and newborn/neonatal care, to name just a few. See, e.g., EX1010 at
`
`13, 214; EX1011 at 98; EX1013 at 1347, 1351; EX1014 at 403. Recently, ease of
`
`use and portability led to pulse oximeter monitoring to be virtually universally
`
`recommended for at home patients having COVID-19 symptoms. EX2004 at 5; see
`
`generally 2012.
`
`B. How Oximetry Works
`27.
`Pulse oximetry determines oxygen saturation by leveraging the light
`
`absorbance of oxygenated hemoglobin and deoxygenated hemoglobin at two
`
`different wavelengths. EX1010 at 13; EX1013 at 1349-1351. As the blood flow
`
`pulsates, it modulates the light absorption. EX1010 at 14; EX1013 at 1050. Changes
`
`in light absorbance are tracked as the blood pulses. EX1010 at 34.
`
`28. A noninvasive sensor of a typical pulse oximeter generally includes
`
`“red and infrared (IR) light-emitting diode (LED) emitters and a photodiode
`
`detector.” EX1001 at 1:34-36. “[T]he emitters project light through . . . [a user’s
`
`tissue, and the detector] detect[s] the . . . light as it emerges from the . . . [tissues].”
`
`Id. at 1:38-42.
`
`29.
`
`Because light both transmits through tissue and backscatters or reflects
`
`back after entering tissue, pulse oximeter sensors can operate either by transmittance
`
`or reflectance. That is, for pulse oximeter sensors operating by transmittance, a
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`detector (sometimes referred to as a photodiode) is placed on the opposite side of a
`
`tissue from emitters. EX1010 at 36. For pulse oximeter sensors operating by
`
`reflectance, a detector is placed on the same side as emitters. Id. The following
`
`figures show a simplified depiction of transmittance and reflectance operations:
`
`
`
`Id. As shown above, in the reflectance configuration, when the light reflects back
`
`toward the sensor, the light may approach the photodiode at an angle.
`
`30.
`
`Photodiodes cannot distinguish between red and infrared light.
`
`EX1010 at 36. Thus, an oximeter device “alternately activates the . . . emitters.”
`
`EX1001 at 1:47-48. The resulting “[l]ight 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; EX1010
`
`at 100. The scattering effects of blood and tissue necessitate the arterial oxygen
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`saturation value to be empirically determined based on the ratio obtained. EX1001
`
`at 1:51-52; EX1010 at 14; EX1013 at 1351.
`
`31.
`
`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.
`
`EX1010 at 54, 159. Calibration curves are highly sensitive to even small changes to
`
`any particular optical system as such changes affect the incoming values of the
`
`ratiometric data. Any change in the optical system could throw off the gain or change
`
`the signal-to-noise ratio, neither of which is sufficiently proportional or linear that
`
`the signal processing or calibration curve could be kept the same. If the signal
`
`processing or calibration curve were kept the same, the changes to the optical system
`
`could corrupt the signal and degrade the accuracy of the output measurement.
`
`Without an accurate calibration curve, the pulse oximeter has no way of determining
`
`oxygen saturation levels. EX1010 at 159.
`
`32.
`
`For this reason, optical system modifications often require expensive
`
`clinical data collection to generate new calibration curves, even potentially requiring
`
`new FDA clearances. EX2005 at 4-5. Because calibration curves are empirically
`
`determined by clinical studies, optical system modifications require expensive new
`
`clinical trials to generate calibration curves to obtain the new FDA approvals.
`
`EX1010 at 54, 159-163; EX1001 at 1:50-54. Clinical trials and FDA approvals are
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`significantly costly in time, resources, and expense. Without a compelling motivation
`
`to modify the optical system of a pulse oximeter, a POSITA would not risk the costly
`
`and time-consuming drawbacks of updating the calibration curve and preparing a new
`
`510(k) submission.
`
`C. The ’994 Patent
`33. With the criticality of pulse oximetry monitoring in a large number of
`
`varied environments, including recent COVID-19 patient monitoring (EX2004 at 5),
`
`the ’994 Patent discloses the need to avoid a detector producing “a false signal that
`
`might be interpreted . . . as a physiological signal”; that is, a false signal wrongly
`
`interpreted as a signal responsive to the user’s oxygen supply. 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 . . ., potentially leading to missed desaturation events.”
`
`Id. at 4:38-42. This was typically avoided by choosing an appropriate sensor for the
`
`patient’s size and by ensuring that the sensor remains securely in position. EX1010
`
`at 95; see also EX1006 at 1:48–2:58.
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`34.
`
`In contrast to prior approaches, the ’994 patent discloses an innovative
`
`solution that includes louvers “placed in front of the . . . photodetector to filter out
`
`oblique light rays.” EX1001 at Abstract, 2:9-12. The louvers actually “prevent light
`
`from an 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.
`
`35.
`
`For example, Fig. 5A (reproduced below) of the ’994 Patent, shows
`
`“[t]he louvers 502 block light rays travelling along an oblique path 410.” Id. at 6:28-
`
`30.
`
`
`
`Id. at FIG. 5A. That is, when light rays from the emitter 220 follow a path 410 that
`
`is oblique to an orientation of the louvers 502 (here shown as vertical), the
`
`louvers 502 prevent passage of those light rays to the detector assembly 235. “With
`
`no [oblique] light rays reaching the detector assembly 235, the detector will produce
`
`no signal” (Id. at 6:49-51), thereby avoiding the production of “a false signal that
`
`could be interpreted by the pulse oximeter 140 to be a physiological signal.” Id. at
`
`6:53-56.
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`D.
`36.
`
`Introduction to Claim 15 of the ’994 Patent
`I understand only one claim of the ’994 Patent is at issue in this IPR
`
`proceeding. Claim 15 reads as follows:
`
`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:
`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.
`V. CLAIM CONSTRUCTION
`I have been asked to provide my opinions regarding the construction of
`
`37.
`
`“a plurality of louvers positioned over the light sensitive detector to accept light from
`
`the at least one light emission dev
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