throbber

`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`
`
`
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`
`
`
`
`
`
`
`
`
`
`DECLARATION OF DR. MAJID SARRAFZADEH
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`- i -
`
`Apple Inc.
`APL1003
`U.S. Patent No. 8,923,941
`
`FITBIT, Ex. 1003
`
`

`

`V.
`
`TABLE OF CONTENTS
`Introduction ...................................................................................................... 1
`I.
`II. Qualifications ................................................................................................... 3
`III. Legal Principles ............................................................................................... 5
`IV. Background and State of the Art............................................................10
`A. Wearable Technology ............................................................................16
`B. Communication ......................................................................................19
`C. Noise Artifacts .......................................................................................20
`D. Adaptive Filtering Techniques ...............................................................24
`The ’941 Patent ..............................................................................................27
`A. Summary of the Prosecution History .....................................................28
`B. Level of Ordinary Skill of a Person in the Art.......................................29
`C. Claim Construction ................................................................................30
`1. “a body” ........................................................................................30
`2. “headset” .......................................................................................30
`3. “housing” ......................................................................................31
`4. “chipset” ........................................................................................32
`5. “window” ......................................................................................33
`VI. Ground 1: Claims 14–15 and 21 are unpatentable under pre-AIA 35 U.S.C.
`§ 103(a) over Kosuda in view of Maekawa. ..................................................34
`A. Overview of Kosuda ..............................................................................34
`B. Overview of Maekawa ...........................................................................39
`C. Claim 14 .................................................................................................42
`[14.P] A wearable device ....................................................................42
`[14.1] a housing ...................................................................................43
`[14.2] a chipset enclosed within the housing ......................................43
`[14.3] at least one PPG sensor .............................................................45
`[14.4] at least one motion sensor .........................................................47
`[14.5] at least one signal processor configured to process signals from
`the at least one motion sensor and signals from the at least one
`PPG sensor to reduce motion artifacts from the PPG signals ......47
`
`
`
`- ii -
`
`FITBIT, Ex. 1003
`
`

`

`[14.6] the housing comprises at least one window that optically
`exposes the at least one PPG sensor to a body of a subject wearing
`the device ......................................................................................50
`[14.7] the housing comprises non-air light transmissive material in
`optical communication with the at least one PPG sensor and the
`window ..........................................................................................51
`D. Claim 15 .................................................................................................54
`E. Claim 21 .................................................................................................55
`VII. Ground 2: Claims 18–20 are unpatentable under pre-AIA 35 U.S.C. § 103(a)
`over Kosuda in view of Maekawa and Han. ..................................................56
`F. Claims 18-20 ..........................................................................................56
`1. Overview of Han ...........................................................................58
`G. Rationale to Combine the Teachings of Kosuda, Maekawa, and Han ..62
`VIII. Ground 3: Claims 14-19 and 21 are unpatentable under pre-AIA 35 U.S.C.
`§ 103(a) over Aceti in view of Fricke. ..........................................................63
`A. Overview of Aceti ..................................................................................63
`B. Overview of Fricke ................................................................................66
`C. Claim 14 .................................................................................................71
`[14.P] A wearable device ....................................................................71
`[14.1] a housing ...................................................................................72
`[14.2] a chipset enclosed within the housing ......................................72
`[14.3] at least one PPG sensor .............................................................74
`[14.4] at least one motion sensor .........................................................75
`[14.5] at least one signal processor configured to process signals from
`the at least one motion sensor and signals from the at least one
`PPG sensor to reduce motion artifacts from the PPG signals ......75
`[14.6] the housing comprises at least one window that optically
`exposes the at least one PPG sensor to a body of a subject wearing
`the device ......................................................................................78
`[14.7] the housing comprises non-air light transmissive material in
`optical communication with the at least one PPG sensor and the
`window ..........................................................................................79
`D. Claim 15 .................................................................................................79
`
`
`
`- iii -
`
`FITBIT, Ex. 1003
`
`

`

`E. Claims 16 and 17 ...................................................................................80
`F. Claims 18 and 19 ...................................................................................80
`G. Claim 21 .................................................................................................85
`IX. Ground 4: Claim 20 is unpatentable under pre-AIA 35 U.S.C. § 103(a) over
`Aceti in view of Fricke and Comtois. ............................................................85
`A. Overview of Comtois .............................................................................85
`B. Rationale to Combine the Teachings of Aceti, Fricke, and Comtois ....88
`Conclusion .....................................................................................................88
`
`
`X.
`
`
`
`
`
`
`
`- iv -
`
`FITBIT, Ex. 1003
`
`

`

`Exhibit No.
`1001
`
`1002
`1004
`1006
`
`1008
`
`1009
`
`1010
`
`1011
`
`1016
`
`1018
`
`1019
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`
`
`EXHIBIT LIST
`
`Description
`U.S. Patent No. 8,923,941 to LeBoeuf et al., issued December 30,
`2014
`U.S. Patent No. 8,923,941 File History
`Curriculum Vitae of Dr. Majid Sarrafzadeh
`U.S. Patent Application Publication No. 2005/0209516 to Fraden,
`published September 22, 2005
`U.S. Patent Application Publication No. 2008/0081972 to
`Debreczeny, published April 3, 2008
`Japanese Patent Application Publication No. 2005/040261 A to
`Numaga et al., published February 17, 2005
`Certified English-language translation of Japanese Patent
`Application Publication No. 2005/040261 A to Numaga et al.,
`published February 17, 2005
`U.S. Patent Application Publication No. 2003/0065269 to Vetter et
`al., published April 3, 2003
`U.S. Patent Application Publication No. 2009/0105556 to Fricke et
`al., published April 23, 2009
`U.S. Patent No. 3,704,706 to Herczfeld et al., issued December 5,
`1972
`U.S. Patent No. 5,297,548 to Pologe, issued March 29, 1994
`Med. Sci. Series, Int’l Fed’n for Med. and Biological Eng’g and the
`Int’l Org. for Med. Physics, Design of Pulse Oximeters (J.G.
`Webster ed., Inst. of Physics Publ’g 1997)
`John Allen, Photoplethysmography and its application in clinical
`physiological measurement, Physiological Measurement 28 (2007)
`U.S. Patent Application Publication No. 2008/0132798 to Hong et
`al., published June 5, 2008
`U.S. Patent Application Publication No. 2008/0177162 to Bae,
`published July 24, 2008
`U.S. Patent No. 5,807,267 to Bryars et al., issued September 15,
`1998
`Hyonyoung Han et al., Development of a wearable health
`monitoring device with motion artifact reduced algorithm,
`International Conference on Control, Automation and Systems,
`IEEE (2007)
`Excerpt from Merriam Webster’s Collegiate Dictionary,
`
`- v -
`
`FITBIT, Ex. 1003
`
`

`

`Exhibit No.
`
`1027
`
`1028
`
`1029
`
`1030
`
`1031
`
`1032
`
`1034
`
`1035
`
`1036
`
`1037
`
`1038
`
`1039
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`
`
`
`Description
`Eleventh Edition, 2008; p. 603
`U.S. Patent Application Publication No. 2004/0186387 to Kosuda
`et al., published September 23, 2004
`U.S. Patent Application No. 2009/0287067 to Dorogusker et al.,
`published November 19, 2009
`Japanese Patent Application Publication No. 2005/270544 to
`Maekawa, published October 6, 2005
`Certified English-language translation of Japanese Patent
`Application Publication No. 2005/270544 to Maekawa, published
`October 6, 2005
`U.S. Patent Application No. 2005/059870 to Aceti, published
`March 17, 2005
`G. Comtois & Y. Mendelson, A Comparative Evaluation of
`Adaptive Noise Cancellation Algorithms for Minimizing Motion
`Artifacts in a Forehead-Mounted Wearable Pulse Oximeter, IEEE
`(2007)
`U.S. Patent Application Publication No. 2004/0059236 to
`Margulies et al., published March 25, 2004
`U.S. Patent Application Publication No. 2007/0016086 to Inukai et
`al., published January 18, 2007
`U.S. Patent Application Publication No. 2003/0236647 to Yoon et
`al., published December 25, 2003
`International Patent Application Publication No. 2007/013054 to
`Schwartz, published February 1, 2007
`U.S. Patent No. 5,575,284 to Athan et al., issued November 19,
`1996
`U.S. Patent No. 5,503,016 to Koen, issued April 2, 1996
`U.S. Patent Application Publication No. 2008/0154098 to Morris et
`al., published June 26, 2008
`U.S. Patent Application Publication No. 2007/0027367 to Oliver et
`al., published February 1, 2007
`U.S. Patent Application Publication No. 2007/0197881 to Wolf et
`al., published August 23, 2007
`U.S. Patent Application Publication No. 2005/0075542 to
`Goldreich, published April 7, 2005
`International Patent Application Publication No. WO2007/004089
`to Moroney et al., published January 11, 2007
`G. Sen Gupta et al., Design of a Low-cost Physiological Parameter
`
`- vi -
`
`FITBIT, Ex. 1003
`
`

`

`Exhibit No.
`
`1046
`
`1047
`
`1048
`1049
`
`1050
`
`1051
`
`1053
`
`1054
`
`
`Description
`Measurement and Monitoring Device,
`Instrumentation and
`Measurement Technology Conference, IEEE (2007)
`U.S. Patent Application Publication No. 2006/0084879 to Nazarian
`et al., published April 20, 2006
`U.S. Patent No. 5,243,992 to Eckerle et al., issued September 14,
`1993
`U.S. Patent No. 4,955,379 to Hall, issued September 11, 1990
`International Patent Application Publication No. WO 2007/122375
`to Crowe et al., published November 1, 2007
`Excerpt from Wiley Electrical and Electronics Engineering
`Dictionary, 2004; p. 110
`Excerpt from Dictionary of Computer and Internet Terms, 2009; p.
`90
`U.S. Patent No. 6,801,799 to Mendelson et al., issued October 5,
`1990
`U.S. Patent No. 6,898,451 to Wuori, issued May 24, 2005
`
`
`
`
`- vii -
`
`FITBIT, Ex. 1003
`
`

`

`I.
`
`Introduction
`
`I, Dr. Majid Sarrafzadeh, declare as follows:
`
`1.
`
`I am currently a distinguished professor of computer science at the
`
`University of California at Los Angeles (“UCLA”), director of the UCLA
`
`Embedded and Reconfigurable Computing Laboratory (“ER Lab”), and a co-
`
`director of the UCLA Center for SMART Health. I have been actively engaged in
`
`research of Wearable Systems for 16 years and Embedded Systems, Design and
`
`Analysis of Algorithms, and Health Analytics for about 29 years.
`
`2.
`
`I have been retained on behalf of Apple Inc. to provide expert
`
`opinions in connection with a petition for Inter Partes Review before the United
`
`States Patent and Trademark Office. I understand that this declaration involves my
`
`expert opinions and expert knowledge related to U.S. Patent No. 8,923,941 (“the
`
`’941 patent”), titled “Methods and Apparatus for Generating Data Output
`
`Containing Physiological and Motion-Related Information,” and its field of
`
`endeavor.
`
`3.
`
`In preparing this declaration, I have reviewed and am familiar with the
`
`’941 Patent (Ex. 1001) and its file history (Ex. 1002). The ’941 Patent relates to a
`
`“physiological monitoring apparatus” and describes “a method of generating a data
`
`string containing physiological and motion-related information.” Ex. 1001, 1:21,
`
`Abstract. I am familiar with the technology and state of the art described in the
`
`
`
`
`- 1 -
`
`FITBIT, Ex. 1003
`
`

`

`’941 Patent as of its February 19, 2014 filing date, as well as the technology and
`
`state of the art as of its claimed February 25, 2009 priority date.
`
`4.
`
`I have reviewed and am familiar with each exhibit cited herein. I
`
`confirm that to the best of my knowledge that the accompanying exhibits are true
`
`and accurate copies of what they purport to be, and that an expert in the field
`
`would reasonably rely on them to formulate opinions such as those set forth in this
`
`declaration.
`
`5.
`
`I have been asked to provide my independent technical review,
`
`analysis, insights, and opinions regarding the ’941 Patent and the references that
`
`form the basis for the four grounds of unpatentability set forth in the Petition for
`
`Inter Partes Review of the ’941 Patent.
`
`Ground
`
`References
`
`Basis
`
`Claims Challenged
`
`1
`
`2
`
`3
`
`4
`
`Kosuda & Maekawa
`
`§ 103 14, 15, 21
`
`Kosuda, Maekawa, & Han
`
`§ 103 18–20
`
`Aceti & Fricke
`
`§ 103 14-19, 21
`
`Aceti, Fricke, & Comtois
`
`§ 103 20
`
`
`
`
`- 2 -
`
`FITBIT, Ex. 1003
`
`

`

`II. Qualifications
`As indicated in my curriculum vitae (filed as Ex. 1004), I am
`6.
`
`currently a professor of computer science at UCLA and have been in that position
`
`for the last sixteen years. I am also the director of the UCLA Embedded and
`
`Reconfigurable Computing Laboratory (“ER Lab”), a co-director of the UCLA
`
`Center for SMART Health, a co-director of the BRITE Center on Minority Health
`
`Disparities, and a co-founder of UCLA Wireless Health Institute.
`
`7.
`
`I earned a Bachelor of Science, Master of Science, and Ph.D. degrees
`
`from the University of Illinois at Urbana-Champaign in Electrical and Computer
`
`Engineering in 1982, 1984, and 1987, respectively.
`
`8.
`
`I became an Assistant Professor of Electrical and Computer
`
`Engineering at Northwestern University in 1987, earned tenure in 1993, and
`
`became a Full Professor in 1997.
`
`9.
`
`In 2000, I joined the Computer Science Department at UCLA as a
`
`Full Professor. In 2008, I co-founded and became a director of the UCLA Wireless
`
`Health Institute. I currently teach two core undergraduate courses (involving
`
`implementing digital logic designs and advanced digital design techniques), a
`
`course on Algorithms and Complexity, and a series of graduate courses in the area
`
`of embedded systems and Wireless Health.
`
`
`
`
`- 3 -
`
`FITBIT, Ex. 1003
`
`

`

`10.
`
`I have experience as a system designer, circuit designer, and software
`
`designer. This experience includes positions as a design engineer at IBM and
`
`Motorola and a test engineer at Central Data Corporation. I was the main architect
`
`of an Electronic Design Automation (“EDA”) software tool for Monterey Design
`
`Systems, Inc. (“Monterey”). I co-founded and managed the technical team at
`
`Hierarchical Design, Inc. (“Hier Design”), an EDA company that specialized in
`
`reconfigurable field-programmable gate array (FPGA) systems. Hier Design was
`
`acquired by Xilinx in 2004. I have cofounded MediSens Wireless, Bruin
`
`Biometrics, and WANDA Health.
`
`11.
`
`I am a Fellow of the Institute of Electrical and Electronics Engineers,
`
`Inc. (“IEEE”) for my contributions to “Theory and Practice of VLSI Design.” I
`
`have served on the technical program committees of numerous conferences in the
`
`area of system design. I cofounded the International conference on Wireless Health
`
`and have served in various committees of this conference.
`
`12.
`
`I have published approximately 500 papers, and have received a
`
`number of best paper and distinguished paper awards. I am a co-author of the book
`
`“Synthesis Techniques and Optimizations for Reconfigurable Systems” (2003 by
`
`Springer) and a co-author of the papers such as:
`
`• Adaptive Electrocardiogram Feature Extraction on Distributed
`
`Embedded Systems, IEEE Transactions on Parallel and Distributed
`
`
`
`
`- 4 -
`
`FITBIT, Ex. 1003
`
`

`

`Systems special issue on High Performance Computational Biology
`
`(2006);
`
`• A Remote Patient Monitoring System for Congestive Heart Failure,
`
`Journal of Medical Systems (2011);
`
`• SmartFall: An Automatic Fall Detection and Cause Identification
`
`System, IEEE Sensors Journal (2013); and
`
`• Designing a Robust Activity Recognition Framework for Health and
`
`Exergaming using Wearable Sensors, IEEE Journal of Biomedical
`
`and Health Informatics (2013).
`
`13. A more detailed account of my work experience and qualifications,
`
`including a list of all publications authored in the previous 10 years, can be found
`
`in my curriculum vitae, which is identified as Ex. 1004.
`
`14.
`
`I am being compensated at my standard rate of $650 per hour for my
`
`work on this case. My compensation is not dependent upon my opinions or
`
`testimony or the outcome of this case.
`
`III. Legal Principles
`I understand that my analysis requires an understanding of the scope
`15.
`
`of the ’941 Patent claims. I understand that the disclosures of the ’941 Patent and
`
`the prior art are judged from the perspective of a person of ordinary skill in the art
`
`at the time of the purported invention. For the purposes of this declaration, I have
`
`
`
`
`- 5 -
`
`FITBIT, Ex. 1003
`
`

`

`been instructed to consider the time of the purported invention of the ’941 Patent to
`
`be February 25, 2009 for each challenged claim unless noted otherwise. I will note,
`
`however, that my opinions would not change even if all the relevant disclosures
`
`were judged from a later time period.
`
`16.
`
`I understand that terms of the ’941 Patent claims are, by rule, given
`
`the broadest reasonable construction in light of its specification. Unless otherwise
`
`noted, I have generally given the claim terms their plain and ordinary meaning as
`
`understood by a person of ordinary skill in the art at the time of purported
`
`invention.
`
`17.
`
`I understand that a claim is invalid if it is anticipated or obvious. My
`
`opinions here relate to both anticipation and obviousness as detailed below.
`
`18.
`
`I understand that anticipation of a claim requires that every element of
`
`a claim is expressly or inherently disclosed in a single prior art reference. I
`
`understand that an anticipating reference need not use the exact terms of the
`
`claims, but must describe the patented subject matter with sufficient clarity and
`
`detail to establish that the claimed subject matter existed in the prior art and that
`
`such existence would be recognized by persons of ordinary skill in the field of the
`
`purported invention. I also understand that an anticipating reference must enable
`
`one of ordinary skill in the art to reduce the purported invention to practice without
`
`undue experimentation.
`
`
`
`
`- 6 -
`
`FITBIT, Ex. 1003
`
`

`

`19.
`
`I understand that an obviousness analysis involves comparing a claim
`
`to the prior art to determine whether the claimed invention would have been
`
`obvious to a person of ordinary skill in the art at the time of the invention in view
`
`of the prior art and in light of the general knowledge in the art as a whole. I also
`
`understand that obviousness is ultimately a legal conclusion based on underlying
`
`facts of four general types, all of which must be considered: (1) the scope and
`
`content of the prior art; (2) the level of ordinary skill in the art; (3) the differences
`
`between the claimed invention and the prior art; and (4) any objective indicia of
`
`nonobviousness.
`
`20.
`
`I also understand that obviousness may be established by combining
`
`or modifying the teachings of the prior art. Specific teachings, suggestions, or
`
`motivations to combine any first prior art reference with a second prior art
`
`reference can be explicit or implicit, but must have existed before the date of
`
`invention. I understand that prior art references themselves may be one source of a
`
`specific teaching or suggestion to combine features of the prior art, but that such
`
`suggestions or motivations to combine art may come from the knowledge of a
`
`person of ordinary skill in the art. Specifically, a rationale to combine the teachings
`
`of references may include logic or common sense available to a person of ordinary
`
`skill in the art.
`
`
`
`
`- 7 -
`
`FITBIT, Ex. 1003
`
`

`

`21.
`
`I understand that a reference may be relied upon for all that it teaches,
`
`including uses beyond its primary purpose. I understand that though a reference
`
`may be said to teach away when a person of ordinary skill, upon reading the
`
`reference, would be discouraged from following the path set out in the reference,
`
`the mere disclosure of alternative designs does not teach away.
`
`22.
`
`I further understand that whether there is a reasonable expectation of
`
`success from combining references in a particular way is also relevant to the
`
`analysis. I understand there may be a number of rationales that may support a
`
`conclusion of obviousness, including:
`
`• Combining prior art elements according to known methods to yield
`
`predictable results;
`
`• Substitution of one known element for another to obtain predictable
`
`results;
`
`• Use of known technique to improve similar devices (methods, or
`
`products) in the same way;
`
`• Applying a known technique to a known device (method, or product)
`
`ready for improvement to yield predictable results;
`
`• “Obvious to try” – choosing from a finite number of identified,
`
`predictable solutions, with a reasonable expectation of success;
`
`
`
`
`- 8 -
`
`FITBIT, Ex. 1003
`
`

`

`• Known work in one field of endeavor may prompt variations of it for use
`
`in either the same field 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; or
`
`• Some teaching, suggestion, or motivation in the prior art that would have
`
`led one of ordinary skill to modify the prior art reference or to combine
`
`prior art teachings to arrive at the claimed invention.
`
`23.
`
`I understand that it is not proper to use hindsight to combine
`
`references or elements of references to reconstruct the invention using the claims
`
`as a guide. My analysis of the prior art is made from the perspective of a person of
`
`ordinary skill in the art at the time of the purported invention.
`
`24.
`
`I understand that so-called objective considerations may be relevant to
`
`the determination of whether a claim is obvious should the Patent Owner allege
`
`such evidence. Such objective considerations can include evidence of commercial
`
`success caused by an invention, evidence of a long-felt need that was solved by an
`
`invention, evidence that others copied an invention, or evidence that an invention
`
`achieved a surprising result. I understand that such evidence must have a nexus, or
`
`causal relationship to the elements of a claim, in order to be relevant to the
`
`obviousness or non-obviousness of the claim. I am unaware of any such objective
`
`considerations having a nexus to the claims at issue in this proceeding.
`
`
`
`
`- 9 -
`
`FITBIT, Ex. 1003
`
`

`

`25.
`
`I understand that for a reference to be used to show that a claim is
`
`obvious, the reference must be analogous art to the claimed invention. I understand
`
`that a reference is analogous to the claimed invention if the reference is from the
`
`same field of endeavor as the claimed invention, even if it addresses a different
`
`problem, or if the reference is reasonably pertinent to the problem faced by the
`
`inventor, even if it is not in the same field of endeavor as the claimed invention. I
`
`understand that a reference is reasonably pertinent based on the problem faced by
`
`the inventor as reflected in the specification, either explicitly or implicitly.
`
`IV. Background and State of the Art
`26. Photoplethysmography (hereinafter also referred to as ‘PPG’) 1 refers
`
`to the use of light to measure the changes in blood volume in the tissue of a living
`
`body. Ex. 1021 (Allen - Photoplethysmography and its application in clinical
`
`physiological measurement), § 1. The technique was introduced in 1937 and had
`
`become a ubiquitous part of physiological monitoring long before the ʼ941 Patent
`
`
`1 Photoplethysmographic, photoplethysmogram, and photoplethysmography are all
`
`terms abbreviated PPG. Other abbreviations, however, such as PTG, are also
`
`occasionally used in the art. Ex. 1034 (Margulies – US 2004/0059236), ¶ 0054; Ex.
`
`1035 (Inukai – US 20070016086), ¶ 0027; Ex. 1036 (Yoon – US 2003/0236647), ¶
`
`0052.
`
`
`
`
`- 10 -
`
`FITBIT, Ex. 1003
`
`

`

`was filed. Ex. 1021, § 2.3. By 2009, the earliest claimed priority date, PPG
`
`technology was in widespread use and established as a simple, low-cost, readily-
`
`portable choice for both clinical and non-clinical physiological measurements. Ex.
`
`1021, § 2.3.
`
`27. PPG is an optical technique whereby light is projected into living
`
`tissue, and the reflected light is detected after its interaction with the skin, blood,
`
`and other tissue. Ex. 1021, § 1. The intensity of the reflected light depends on the
`
`volume of blood. Ex. 1021, § 1. The volume of blood fluctuates proportionally
`
`with the cardiac cycle. Ex. 1021, § 1. As a result, a PPG sensor detects a time-
`
`varying pulsatile waveform, or pulse wave, that is synchronized with each
`
`heartbeat. Ex. 1021, § 1.
`
`28. A 1972 patent illustrates many of the conventional components of a
`
`PPG heart rate monitor using an optical technique to continuously measure the
`
`pulse of a subject. Ex. 1018 (Herczfeld - US 3,704,706). As shown below, the
`
`small probe housing included a light source to emit light directly into the finger of
`
`a subject and a photodetector to collect light directly from the finger. Ex. 1018,
`
`2:60-3:22, fig. 1 (annotated, reproduce below).
`
`
`
`
`- 11 -
`
`FITBIT, Ex. 1003
`
`

`

`
`
`
`
`Light source
`Housing
`
`Incident
`light
`
`
`
`
`
`Photodetector
`
`Reflected
`light
`
`
`
`Ex. 1018, fig. 1 (annotations added).
`
`29.
`
`In operation, the probe was placed upon the patient’s finger such that
`
`blood flowing in the finger’s capillaries reflected incident red light. Ex. 1018, 3:40-
`
`42, Fig. 1; Ex. 1020 (Webster – Design of Pulse Oximeters), pp. 34-36. The
`
`intensity of the reflected light was understood to be inversely proportional to the
`
`amount of blood flowing in the finger. Ex. 1018, 3:42-55; Ex. 1020, pp. 40-49. For
`
`each heartbeat, blood pumped into and out of the capillaries, thereby causing a
`
`periodic decrease and increase in the reflected light intensity. Ex. 1018, 3:42-55;
`
`Ex. 1020, pp. 40-49. The detected periodic waveform was known to represent a
`
`volume of the circulating blood synchronized to each heartbeat. Ex. 1018, 3:42-55;
`
`Ex. 1020, pp. 40-49. This pulsatile waveform was known as a
`
`photoplethysmographic pulse wave. Ex. 1020, pp. 13-18, 40-49; Ex. 1021, § 2.1.
`
`
`
`
`- 12 -
`
`FITBIT, Ex. 1003
`
`

`

`
`
`Ex. 1020, p. 47.
`
`30. Hence, PPG was an old, well-known optical measurement technique
`
`used to detect blood volume changes in living tissue. Ex. 1021, § 1; Ex. 1020, pp.
`
`240-241. The basic form of PPG technology requires only a few opto-electronic
`
`components: a light source (often red or near infrared) to illuminate the tissue
`
`(commonly at the ear, wrist, or finger) and a photodetector to measure the small
`
`variations in light intensity associated with changes in blood volume. Ex. 1021, §§
`
`1, 2.4; Ex. 1020, pp. 34-38. A simple, appropriately programmed signal processor
`
`can extract heart rate, respiratory rate, blood oxygen saturation (SpO2), and a
`
`variety of other physiological parameters. Ex. 1021, § 3; Ex 10XX (Schwartz -
`
`WO 2007/013054), 5:5-9, 10:6-20. The idealized model of absorbed and
`
`transmitted light in living tissue (shown above) illustrates that pulsation of arterial
`
`blood can dominate the pulse wave signal and the contribution from venous blood
`
`
`
`
`- 13 -
`
`FITBIT, Ex. 1003
`
`

`

`is therefore often ignored while the subject is at rest. It was also known, however,
`
`that body movement (such as walking, running, and the like) can significantly
`
`affect venous blood flow and hence the PPG signal, which cannot be ignored. Ex.
`
`1027 (Kosuda – US 2004/0186387), ¶¶ 230-232, 0345-0347.
`
`
`
`31. Photoplethysmography has had widespread clinical application, with
`
`the technology utilized in commercially available medical devices, such as pulse
`
`oximeters. Ex. 1021, § 1. A major advance in the clinical use of PPG-based
`
`technology came with the introduction of the pulse oximeter as a non-invasive
`
`method for monitoring patients’ arterial oxygen saturation (SpO2). Ex. 1021, § 2.3;
`
`Ex. 1020, preface. Oxygen saturation of the hemoglobin in arterial blood is
`
`determined by the relative proportions of oxygenated hemoglobin and reduced
`
`hemoglobin in the arterial blood. Ex. 1019 (Pologe - US 5,297,548), 1:20-56; Ex.
`
`1020, pp. 34-38. A pulse oximeter uses PPG signals to determine the oxygen
`
`saturation of the hemoglobin by measuring the difference in the light absorption of
`
`these two forms of hemoglobin. Ex. 1019, 1:20-56, fig. 1 (a display module of a
`
`
`
`
`- 14 -
`
`FITBIT, Ex. 1003
`
`

`

`pulse oximeter is shown below); Ex. 1020, pp. 34-38, fig. 12.2. Reduced or
`
`deoxygenated hemoglobin absorbs more light in the red band (600-800 nm) than
`
`does oxyhemoglobin, while oxyhemoglobin absorbs more light in the near infrared
`
`band (800-1000 nm) than does reduced hemoglobin. Ex. 1019, 1:20-56; Ex. 1020,
`
`pp. 34-38, 86-88. Oxygen saturation is then estimated based on the ratio between
`
`the detected intensity of red and infrared light. Ex. 1019, 1:20-56; Ex. 1020, pp.
`
`34-38.
`
`32. The pulse oximeter typically includes a probe which contains two
`
`light emitting diodes, one red and one infrared, and is placed in contact with the
`
`skin. Ex. 1019, 1:20-56; Ex. 1020, pp. 34-38. There were conventionally two types
`
`of probes for pulse oximetry: reflectance and transmittance. Ex. 1020, pp. 86-89.
`
`Reflectance Probe
`
`
`
`Ex. 1020, pp. 87-88, figs. 7.1, 7.2.
`
`
`
`Transmittance Probe
`
`
`
`33. By the late 1990’s, pulse oximetry was recognized worldwide as a
`
`standard of care in anesthesiology and in widespread use in medical facilities. Ex.
`
`
`
`
`- 15 -
`
`FITBIT, Ex. 1003
`
`

`

`1020, preface. The model 9500 pulse oximeter from Nonin Medical, Inc., shown in
`
`the figure below, was a small sensor commercially available more than a decade
`
`before the effective filing date of the ’941 Patent. Ex. 1020, p. 207, fig. 12.5. With
`
`light weight and an extremely small size, it displays heart rate and oxygen
`
`saturation (SpO2).
`
`
`
`Ex. 1020, p. 207, fig. 12.5.
`
`A. Wearable Technology
`In recent decades, the desire for small, reliable, low-cost and simple-
`34.
`
`to-use noninvasive (cardiovascular) assessment techniques were key factors that
`
`have propelled the use of photoplethysmography. Ex. 1021, § 2.3. Advances in
`
`opto-electronics and clinical instrumentation have also significantly contributed to
`- 16 -
`
`
`
`FITBIT, Ex. 1003
`
`

`

`its advancement. Ex. 1021, § 2.3. The developments in semiconductor technology,
`
`light emitting diodes (LED), photodiodes, and phototransistors have made
`
`considerable improvements in the size, sensitivity, reliability and reproducibility of
`
`PPG probe design. Ex. 1021, § 2.3. Components (such as LEDs, photodiodes,
`
`accelerometers, and microprocessors) would all become available as integrated
`
`circuits or “chips.” Ex. 1020, § 6.1.4, fig. 6.5; Ex. 10XX (Athan

This document is available on Docket Alarm but you must sign up to view it.


Or .

Accessing this document will incur an additional charge of $.

After purchase, you can access this document again without charge.

Accept $ Charge
throbber

Still Working On It

This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.

Give it another minute or two to complete, and then try the refresh button.

throbber

A few More Minutes ... Still Working

It can take up to 5 minutes for us to download a document if the court servers are running slowly.

Thank you for your continued patience.

This document could not be displayed.

We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.

Your account does not support viewing this document.

You need a Paid Account to view this document. Click here to change your account type.

Your account does not support viewing this document.

Set your membership status to view this document.

With a Docket Alarm membership, you'll get a whole lot more, including:

  • Up-to-date information for this case.
  • Email alerts whenever there is an update.
  • Full text search for other cases.
  • Get email alerts whenever a new case matches your search.

Become a Member

One Moment Please

The filing “” is large (MB) and is being downloaded.

Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.

Your document is on its way!

If you do not receive the document in five minutes, contact support at support@docketalarm.com.

Sealed Document

We are unable to display this document, it may be under a court ordered seal.

If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.


Access Government Site

We are redirecting you
to a mobile optimized page.





Document Unreadable or Corrupt

Refresh this Document
Go to the Docket

We are unable to display this document.

Refresh this Document
Go to the Docket