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`UNITED STATES PATENT AND TRADEMARK OFFICE
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`BEFORE THE PATENT TRIAL AND APPEAL BOARD
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`APPLE INC.
`Petitioner
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`v.
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`VALENCELL, INC.
`Patent Owner
`_____________________
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`DECLARATION OF DR. MAJID SARRAFZADEH
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`Apple Inc.
`APL1003
`U.S. Patent No. 8,652,040
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`Inter Partes Review of
`U.S. Patent No. 8,652,040
`
`TABLE OF CONTENTS
`Introduction ...................................................................................................... 1
`I.
`II. Qualifications ................................................................................................... 4
`III. Legal Principles ............................................................................................... 7
`IV. Background and State of the Art ...................................................................12
`A. Wearable Optical Sensors .......................................................................12
`B. Wearable Acoustic Sensors .....................................................................16
`C. Data Transmission from Wearable Sensors ............................................17
`IV. The ’040 Patent ..............................................................................................18
`A. Overview .................................................................................................18
`B. Level of ordinary skill in the art ..............................................................20
`C. Claim construction ..................................................................................21
`1. “physiological information” ............................................................21
`2. “selectively remove … unwanted signals from footsteps” .............22
`3. “secondary optical energy” .............................................................24
`Claim 1 is unpatentable over Aceti in view of Dettling, and further in view
`of Stivoric. .....................................................................................................24
`A. Overview of Aceti ...................................................................................25
`B. Overview of Dettling ...............................................................................28
`C. Overview of Stivoric ...............................................................................29
`D. Motivation to combine Aceti, Dettling, and Stivoric ..............................31
`E. Independent Claim 1 ...............................................................................36
`[1.P] An earpiece module .......................................................................36
`[1.1] an earpiece fitting adapted to be positioned within an ear of a
`person...............................................................................................37
`[1.2] the earpiece fitting comprising: a speaker configured to provide
`sound transmission from a source ...................................................38
`[1.3] the earpiece fitting comprising … an optical emitter, optical
`detector, and acoustic sensor ...........................................................38
`[1.4] wherein the optical emitter is configured to direct optical energy to
`a region of the ear of the person ......................................................39
`
`V.
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`[1.5] wherein the optical detector is configured to sense secondary
`optical energy emanating from the ear region and to sense at least
`one environmental condition in a vicinity of the person .................40
`[1.6] wherein the acoustic sensor is configured to sense footsteps of the
`person...............................................................................................43
`[1.7] the earpiece fitting comprising … a first signal processor
`configured to receive and process signals produced by the optical
`detector ............................................................................................45
`[1.8] a second signal processor configured to process signals produced
`by the first signal processor, and by the acoustic sensor.................46
`[1.9] second signal processor configured to … selectively remove
`unwanted environmental signals and unwanted signals from
`footsteps to produce processed signals containing cleaner
`physiological information from the person .....................................47
`[1.10] a transmitter responsive to the second signal processor that is
`configured to transmit the processed signals containing cleaner
`physiological information to a remote terminal ..............................48
`V. Ground 1: Claims 4, 5, 7, and 56 are unpatentable over Aceti, Dettling, and
`Stivoric in view of Schulze ’692. ..................................................................49
`A. Overview of Schulze ’692 .......................................................................49
`B. Motivation to Combine Schulze ’692 with Aceti, Dettling, and Stivoric
` .................................................................................................................51
`C. Claim 4 ....................................................................................................52
`D. Claim 5 ....................................................................................................53
`E. Claim 7 ....................................................................................................55
`F. Claim 56 ..................................................................................................56
`VI. Grounds 2 and 3: Claim 6 is unpatentable over Aceti, Dettling, Stivoric, and
`Schulze ’692, and further in view of Webster. Claims 8 and 9 are
`unpatentable over Aceti, Dettling, and Stivoric in view of Webster. ............57
`A. Overview of Webster ..............................................................................57
`B. Motivation to Combine Webster with Aceti, Dettling, and Stivoric (or
`with Aceti, Dettling, Stivoric, and Schulze ’692) ...................................58
`C. Claim 6 ....................................................................................................59
`D. Claim 8 ....................................................................................................60
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`E. Claim 9 ....................................................................................................61
`VII. Ground 4: Claims 10 and 47 are unpatentable over Aceti, Dettling, and
`Stivoric in view of Verjus. .............................................................................62
`A. Overview of Verjus .................................................................................62
`B. Motivation to Combine Verjus with Aceti, Dettling, and Stivoric .........63
`C. Claim 10 ..................................................................................................64
`D. Claim 47 ..................................................................................................67
`VIII. Ground 5: Claim 22 is unpatentable over Aceti, Dettling, and Stivoric in
`view of Charych. ............................................................................................67
`A. Overview of Charych ..............................................................................67
`B. Claim 22 ..................................................................................................68
`IX. Ground 6: Claims 26 and 28 are unpatentable over Aceti, Dettling, and
`Stivoric in view of Wendt. .............................................................................69
`A. Overview of Wendt .................................................................................69
`B. Motivation to Combine Wendt with Aceti, Dettling, and Stivoric .........69
`C. Claim 26 ..................................................................................................70
`D. Claim 28 ..................................................................................................71
`X. Ground 7: Claim 33 is unpatentable over Aceti, Dettling, and Stivoric in
`view of Schulze ’890. ....................................................................................72
`A. Overview of Schulze ’890 .......................................................................72
`B. Claim 33 ..................................................................................................72
`XI. Ground 8: Claim 41 is unpatentable over Aceti, Dettling, and Stivoric in
`view of Asada. ...............................................................................................74
`A. Overview of Asada ..................................................................................74
`B. Claim 41 ..................................................................................................74
`XII. Ground 9: Claim 42 is unpatentable over Aceti, Dettling, and Stivoric in
`view of Carroll. ..............................................................................................76
`A. Overview of Carroll ................................................................................76
`B. Claim 42 ..................................................................................................76
`XIII. Ground 10: Claim 54 is unpatentable over Aceti, Dettling, and Stivoric in
`view of Welles. ..............................................................................................78
`A. Overview of Welles .................................................................................78
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`B. Claim 54 ..................................................................................................78
`XIV. Ground 11: Claim 55 is unpatentable over Aceti, Dettling, and Stivoric in
`view of Mac. ..................................................................................................80
`A. Overview of Mac .....................................................................................80
`B. Claim 55 ..................................................................................................80
`XV. Ground 12: Claim 57 is unpatentable over Aceti, Dettling, and Stivoric in
`view of Mac, and further in view of Schulze ’692. .......................................82
`A. Claim 57 ..................................................................................................82
`XVI. Conclusion .....................................................................................................84
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`Inter Partes Review of
`U.S. Patent No. 8,652,040
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`EXHIBIT LIST
`
`Description
`
`U.S. Patent No. 8,652,040 to LeBoeuf et al., issued February 18,
`2014
`
`U.S. Patent No. 8,652,040 File History
`
`Declaration of Dr. Majid Sarrafzadeh
`
`Curriculum Vitae of Dr. Majid Sarrafzadeh
`
`Exhibit No.
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005-1011
`
`INTENTIONALLY LEFT BLANK
`
`1012
`
`John Allen, Photoplethysmography and its application in clinical
`physiological measurement, Physiological Measurement 28 (2007)
`
`1013-1016
`
`INTENTIONALLY LEFT BLANK
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`1017
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`1018
`
`1019
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`1020
`
`J. G. Webster, ed., Design of Pulse Oximeters, IOP Publishing Ltd.,
`1997
`
`International Patent Application Publication No. WO 2007/013054
`to Schwartz, published February 1, 2007
`
`INTENTIONALLY LEFT BLANK
`
`U.S. Patent No. 5,297,548 to Pologe, issued March 29, 1994
`
`1021-1023
`
`INTENTIONALLY LEFT BLANK
`
`1024
`
`1025
`
`1026
`
`U.S. Patent Application Publication No. 2008/0132798 to Hong et
`al., published June 5, 2008
`
`INTENTIONALLY LEFT BLANK
`
`U.S. Patent No. 5,807,267 to Bryars et al., issued September 15,
`1998
`
`1027-1044
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`INTENTIONALLY LEFT BLANK
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`1045
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`U.S. Patent No. 4,672,976 to Kroll, issued June 16, 1987
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`Exhibit No.
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`Description
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`Inter Partes Review of
`U.S. Patent No. 8,652,040
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`1046
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`1047
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`1048
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`1049
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`1050
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`1051
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`1052
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`1053
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`1054
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`1055
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`1056
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`1057
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`1058
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`1059
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`1060
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`U.S. Patent No. 7,539,533 to Tran, issued May 26, 2009
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`U.S. Patent Application Publication No. 2005/0059870 to Aceti,
`published March 17, 2005
`
`U.S. Patent No. 5,954,644 to Dettling et al., issued September 21,
`1999
`
`U.S. Patent Application Publication No. 2004/0039254 to Stivoric
`et al., published February 26, 2004
`
`U.S. Patent Application Publication No. 2008/0076972 to
`Dorogusker et al., published March 27, 2008
`
`U.S. Patent Application Publication No. 2004/0004547 to Appelt et
`al., published January 8, 2004
`
`U.S. Patent Application Publication No. 2007/0116314 to Grilliot et
`al., published May 24, 2007
`
`U.S. Patent Application Publication No. 2004/0242976 to Abreu,
`published December 2, 2004
`
`U.S. Patent No. 5,853,005 to Scanlon, issued December 29, 1998
`
`U.S. Patent Application Publication No. 2009/0131761 to Moroney
`III et al., published May 21, 2009
`
`U.S. Patent Application Publication No. 2006/0064037 to Shalon et
`al., published March 23, 2006
`
`U.S. Patent No. 5,673,692 to Schulze et al., issued October 7, 1997
`
`U.S. Patent Application Publication No. 2003/0233051 to Verjus et
`al., published December 18, 2003
`
`U.S. Patent No. 7,378,954 to Wendt, issued May 27, 2008
`
`U.S. Patent No. 6,267,721 to Welles, issued July 31, 2001
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`Exhibit No.
`
`Description
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`Inter Partes Review of
`U.S. Patent No. 8,652,040
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`1061
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`1062
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`1063
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`1064
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`1065
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`1066
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`1067
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`1068
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`1069
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`U.S. Patent No. 6,022,748 to Charych et al., issued February 8,
`2000
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`U.S. Patent No. 6,443,890 to Schulze et al., issued September 3,
`2002
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`U.S. Patent No. 4,952,928 to Carroll et al., issued August 28, 1990
`
`U.S. Patent No. 5,964,701 to Asada et al., issued October 12, 1999
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`U.S. Patent Application Publication No. 2005/0228463 to Mac et
`al., published October 13, 2005
`
`U.S. Patent No. 8,923,941 to LeBoeuf et al., issued December 30,
`2014
`
`H. Harry Asada et al., “Mobile Monitoring with Wearable
`Photoplethysmographic Biosensors,” IEEE Engineering in
`Medicine and Biology Magazine, May/June 2003, pp. 28-40
`Yuri Shevchenko et al., “90th Anniversary of the Development by
`Nikolai S. Korotkoff of the Ascultatory Method of Measuring
`Blood Pressure,” Circulation, Vol. 94, No. 2, July 15, 1996; pp.
`116-118
`
`Definitions of “blackbody” and “blackbody radiation”, McGraw-
`Hill Dictionary of Scientific and Technical Terms, 4th Edition,
`McGraw-Hill, Inc. (1989); p. 223
`
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`I.
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`Introduction
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`I, Dr. Majid Sarrafzadeh, declare as follows:
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`Inter Partes Review of
`U.S. Patent No. 8,652,040
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`1.
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`I am currently a distinguished professor of computer science at the
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`University of California at Los Angeles (“UCLA”), director of the UCLA
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`Embedded and Reconfigurable Computing Laboratory (“ER Lab”), and a co-
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`director of the UCLA Center for SMART Health. I have been actively engaged in
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`research of Wearable Systems for 16 years and Embedded Systems, Design and
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`Analysis of Algorithms, and Health Analytics for about 29 years.
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`2.
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`I have been retained on behalf of Apple Inc. to provide expert
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`opinions in connection with a petition for Inter Partes Review before the United
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`States Patent and Trademark Office. I understand that this declaration involves my
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`expert opinions and expert knowledge related to U.S. Patent No. 8,652,040 (“the
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`’040 patent”), titled “Telemetric Apparatus for Health and Environmental
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`Monitoring,” and its field of endeavor.
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`3.
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`In preparing this declaration, I have reviewed and am familiar with the
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`’040 Patent (Ex. 1001) and its file history (Ex. 1002). The ’040 Patent relates to an
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`“apparatus for monitoring various physiological and environmental factors” where
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`“an earpiece functions as a physiological monitor, environmental monitor, and a
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`wireless personal communicator.” Ex. 1001, 1:46-48, 1:54-56. I am familiar with
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`the technology and the state of the art described in the ’040 Patent as of its June 12,
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`2007 filing date, as well as the technology and state of the art as of its earliest
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`claimed December 19, 2006 priority date.
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`4.
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`I have reviewed and am familiar with each exhibit cited herein. I
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`confirm that to the best of my knowledge the accompanying exhibits are true and
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`accurate copies of what they purport to be, and that an expert in the field would
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`reasonably rely on them to formulate opinions such as those set forth in this
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`declaration.
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`5.
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`I have been asked to provide my independent technical review,
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`analysis, insights, and opinions regarding the ’040 Patent and the references that
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`form the basis for the grounds of unpatentability set forth in the Petition for Inter
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`Partes Review of the ’040 Patent.
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`Ground
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`References
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`Basis
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`Claims Challenged
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`1
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`2
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`Aceti, Dettling, Stivoric, &
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`§ 103 4, 5, 7, 56
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`Schulze ’692
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`Aceti,
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`Dettling,
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`Stivoric,
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`§ 103 6
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`Schulze ’692, and Webster
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`3
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`4
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`5
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`6
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`7
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`8
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`9
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`Inter Partes Review of
`U.S. Patent No. 8,652,040
`§ 103 8, 9
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`Aceti, Dettling, Stivoric, &
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`Webster
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`Aceti, Dettling, Stivoric, &
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`§ 103 10, 47
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`Verjus
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`Aceti, Dettling, Stivoric, &
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`§ 103 22
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`Charych
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`Aceti, Dettling, Stivoric, &
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`§ 103 26, 28
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`Wendt
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`Aceti, Dettling, Stivoric, &
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`§ 103 33
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`Schulze ’890
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`Aceti, Dettling, Stivoric, &
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`§ 103 41
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`Asada
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`Aceti, Dettling, Stivoric, &
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`§ 103 42
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`Carroll
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`10
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`Aceti, Dettling, Stivoric, &
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`Welles
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`Inter Partes Review of
`U.S. Patent No. 8,652,040
`§ 103 54
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`Aceti, Dettling, Stivoric, & Mac § 103 55
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`Aceti, Dettling, Stivoric, Mac, &
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`§ 103 57
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`Shulze ’692
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`11
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`12
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`
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`II. Qualifications
`As indicated in my curriculum vitae (filed as Ex. 1004), I am
`6.
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`currently a professor of computer science at UCLA and have been in that position
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`for the last sixteen years. I am also the director of the UCLA Embedded and
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`Reconfigurable Computing Laboratory (“ER Lab”), a co-director of the UCLA
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`Center for SMART Health, a co-director of the BRITE Center on Minority Health
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`Disparities, and a co-founder of UCLA Wireless Health Institute.
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`7.
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`I earned a Bachelor of Science, Master of Science, and Ph.D. degrees
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`from the University of Illinois at Urbana-Champaign in Electrical and Computer
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`Engineering in 1982, 1984, and 1987, respectively.
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`Inter Partes Review of
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`I became an Assistant Professor of Electrical and Computer
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`8.
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`Engineering at Northwestern University in 1987, earned tenure in 1993, and
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`became a Full Professor in 1997.
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`9.
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`In 2000, I joined the Computer Science Department at UCLA as a
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`Full Professor. In 2008, I co-founded and became a director of the UCLA Wireless
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`Health Institute. I currently teach two core undergraduate courses (involving
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`implementing digital logic designs and advanced digital design techniques), a
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`course on Algorithms and Complexity, and a series of graduate courses in the area
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`of embedded systems and Wireless Health.
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`10.
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`I have experience as a system designer, circuit designer, and software
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`designer. This experience includes positions as a design engineer at IBM and
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`Motorola and a test engineer at Central Data Corporation. I was the main architect
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`of an Electronic Design Automation (“EDA”) software tool for Monterey Design
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`Systems, Inc. (“Monterey”). I co-founded and managed the technical team at
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`Hierarchical Design, Inc. (“Hier Design”), an EDA company that specialized in
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`reconfigurable Field-Programmable Gate Array (FPGA) systems. Hier Design was
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`acquired by Xilinx in 2004. I have cofounded MediSens Wireless, Bruin
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`Biometrics, and WANDA Health.
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`11.
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`I am a Fellow of the Institute of Electrical and Electronics Engineers,
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`Inc. (“IEEE”) for my contributions to “Theory and Practice of VLSI Design.” I
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`Inter Partes Review of
`U.S. Patent No. 8,652,040
`have served on the technical program committees of numerous conferences in the
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`area of system design. I cofounded the International conference on Wireless Health
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`and have served in various committees of this conference.
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`12.
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`I have published approximately 500 papers, and have received a
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`number of best paper and distinguished paper awards. I am a co-author of the book
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`“Synthesis Techniques and Optimizations for Reconfigurable Systems” (2003 by
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`Springer) and a co-author of the papers such as:
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`• Adaptive Electrocardiogram Feature Extraction on Distributed
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`Embedded Systems, IEEE Transactions on Parallel and Distributed
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`Systems special issue on High Performance Computational Biology
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`(2006);
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`• A Remote Patient Monitoring System for Congestive Heart Failure,
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`Journal of Medical Systems (2011);
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`• SmartFall: An Automatic Fall Detection and Cause Identification
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`System, IEEE Sensors Journal (2013); and
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`• Designing a Robust Activity Recognition Framework for Health and
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`Exergaming using Wearable Sensors, IEEE Journal of Biomedical
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`and Health Informatics (2013).
`
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`13. A more detailed account of my work experience and qualifications,
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`including a list of all publications authored in the previous 10 years, can be found
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`in my curriculum vitae, which is identified as Ex. 1004.
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`14.
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`I am being compensated at my standard rate of $650 per hour for my
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`work on this case. My compensation is not dependent upon my opinions or
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`testimony or the outcome of this case.
`
`III. Legal Principles
`I understand that my analysis requires an understanding of the scope
`15.
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`of the ’040 Patent claims. I understand that the disclosures of the ’040 Patent and
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`the prior art are judged from the perspective of a person of ordinary skill in the art
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`at the time of the purported invention. For the purposes of this declaration, I have
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`been instructed to consider the time of the purported invention of the ’040 Patent to
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`be December 19, 2006 for each challenged claim unless noted otherwise. I will
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`note, however, that my opinions would not change even if all the relevant
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`disclosures were judged from a later time period.
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`16.
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`I understand that terms of the ’040 Patent claims are, by rule, given
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`the broadest reasonable construction in light of its specification. Unless otherwise
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`noted, I have generally given the claim terms their plain and ordinary meaning as
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`understood by a person of ordinary skill in the art at the time of purported
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`invention.
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`I understand that a claim is invalid if it is anticipated or obvious. My
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`17.
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`opinions here relate to both anticipation and obviousness as detailed below.
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`18.
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`I understand that anticipation of a claim requires that every element of
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`a claim is expressly or inherently disclosed in a single prior art reference. I
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`understand that an anticipating reference need not use the exact terms of the
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`claims, but must describe the patented subject matter with sufficient clarity and
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`detail to establish that the claimed subject matter existed in the prior art and that
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`such existence would be recognized by persons of ordinary skill in the field of the
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`purported invention. I also understand that an anticipating reference must enable
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`one of ordinary skill in the art to reduce the purported invention to practice without
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`undue experimentation.
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`19.
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`I understand that an obviousness analysis involves comparing a claim
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`to the prior art to determine whether the claimed invention would have been
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`obvious to a person of ordinary skill in the art at the time of the invention in view
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`of the prior art and in light of the general knowledge in the art as a whole. I also
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`understand that obviousness is ultimately a legal conclusion based on underlying
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`facts of four general types, all of which must be considered: (1) the scope and
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`content of the prior art; (2) the level of ordinary skill in the art; (3) the differences
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`between the claimed invention and the prior art; and (4) any objective indicia of
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`nonobviousness.
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`I also understand that obviousness may be established by combining
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`20.
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`or modifying the teachings of the prior art. Specific teachings, suggestions, or
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`motivations to combine any first prior art reference with a second prior art
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`reference can be explicit or implicit, but must have existed before the date of
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`invention. I understand that prior art references themselves may be one source of a
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`specific teaching or suggestion to combine features of the prior art, but that such
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`suggestions or motivations to combine art may come from the knowledge of a
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`person of ordinary skill in the art. Specifically, a rationale to combine the teachings
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`of references may include logic or common sense available to a person of ordinary
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`skill in the art.
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`21.
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`I understand that a reference may be relied upon for all that it teaches,
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`including uses beyond its primary purpose. I understand that though a reference
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`may be said to teach away when a person of ordinary skill, upon reading the
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`reference, would be discouraged from following the path set out in the reference,
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`the mere disclosure of alternative designs does not teach away.
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`22.
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`I further understand that whether there is a reasonable expectation of
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`success from combining references in a particular way is also relevant to the
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`analysis. I understand there may be a number of rationales that may support a
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`conclusion of obviousness, including:
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`Inter Partes Review of
`U.S. Patent No. 8,652,040
`• Combining prior art elements according to known methods to yield
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`predictable results;
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`• Substitution of one known element for another to obtain predictable
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`results;
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`• Use of known technique to improve similar devices (methods, or
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`products) in the same way;
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`• Applying a known technique to a known device (method, or product)
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`ready for improvement to yield predictable results;
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`• “Obvious to try” – choosing from a finite number of identified,
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`predictable solutions, with a reasonable expectation of success;
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`• Known work in one field of endeavor may prompt variations of it for use
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`in either the same field or a different one based on design incentives or
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`other market forces if the variations are predictable to one of ordinary
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`skill in the art; or
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`• Some teaching, suggestion, or motivation in the prior art that would have
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`led one of ordinary skill to modify the prior art reference or to combine
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`prior art teachings to arrive at the claimed invention.
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`23.
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`I understand that it is not proper to use hindsight to combine
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`references or elements of references to reconstruct the invention using the claims
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`Inter Partes Review of
`U.S. Patent No. 8,652,040
`as a guide. My analysis of the prior art is made from the perspective of person of
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`ordinary skill in the art at the time of the purported invention.
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`24.
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`I understand that so-called objective considerations may be relevant to
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`the determination of whether a claim is obvious should the Patent Owner allege
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`such evidence. Such objective considerations can include evidence of commercial
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`success caused by an invention, evidence of a long-felt need that was solved by an
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`invention, evidence that others copied an invention, or evidence that an invention
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`achieved a surprising result. I understand that such evidence must have a nexus, or
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`causal relationship to the elements of a claim, in order to be relevant to the
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`obviousness or non-obviousness of the claim. I am unaware of any such objective
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`considerations having a nexus to the claims at issue in this proceeding.
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`25.
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`I understand that for a reference to be used to show that a claim is
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`obvious, the reference must be analogous art to the claimed invention. I understand
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`that a reference is analogous to the claimed invention if the reference is from the
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`same field of endeavor as the claimed invention, even if it addresses a different
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`problem, or if the reference is reasonably pertinent to the problem faced by the
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`inventor, even if it is not in the same field of endeavor as the claimed invention. I
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`understand that a reference is reasonably pertinent based on the problem faced by
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`the inventor as reflected in the specification, either explicitly or implicitly.
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`Inter Partes Review of
`U.S. Patent No. 8,652,040
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`IV. Background and State of the Art
`26. The ’040 Patent describes and claims a wearable earpiece module that
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`includes a variety of hardware components. These components include processors,
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`an optical sensor, an acoustic sensor, a speaker, and a transmitter. But the
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`incorporation of these components into a wearable device, such as an earpiece, is
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`not a new concept and has been described in numerous publications for years prior
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`to the December 19, 2006 priority date of the ’040 Patent. In the following
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`sections, I will briefly describe the state of the art for wearable optical sensors,
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`wearable acoustic sensors, and data transmission for wearable sensors during the
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`time before the December 19, 2006 priority date of the ’040 Patent.
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`A. Wearable Optical Sensors
`27. One of the most common optical sensing technique employed in
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`wearable devices for detecting physiological conditions is known as
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`photoplethysmography (hereinafter also referred to as “PPG” or “pulse oximetry”).
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`Hong, Ex. 1024, ¶17, FIG. 1; Bryars, Ex. 1026, FIGs. 1, 6, 7; Asada Article, Ex.
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`1067, p. 28. The technique was introduced in 1937 and had become a ubiquitous
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`part of physiological monitoring long before the ʼ040 Patent was filed. Allen, Ex.
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`1012, § 2.3. By 2006, the earliest claimed priority date, PPG technology was in
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`widespread use and established as a simple, low-cost, readily-portable choice for
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`both clinical and non-clinical physiological measurements. Ex. 1012, § 2.3.
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`Inter Partes Review of
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`28. PPG is an optical technique whereby light is projected into living
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`tissue, and the reflected light is detected after its interaction with the skin, blood,
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`and other tissue. Ex. 1012, § 1. The intensity of the reflected light depends on the
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`volume of blood. Id. The volume of blood fluctuates proportionally with the
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`cardiac cycle. Id. As a result, a PPG sensor detects a time-varying pulsatile
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`waveform, or pulse wave, that is synchronized with each heartbeat. Id.
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`29. Hence, photoplethysmography (PPG) was an old, well-known optical
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`measurement technique used to detect blood volume changes in living tissue. Ex.
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`1012, § 1; Webster, Ex. 1017, pp. 240-241. The basic form of PPG technology
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`requires only a few opto-electronic components: a light source (often red or near
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`infrared) to illuminate the tissue (commonly at the ear, wrist, or finger) and a
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`photodetector to measure the small variations in light intensity associated with
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`changes in blood volume. Ex. 1012, §§ 1, 2.4; Ex. 1017, pp. 34-38. A simple,
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`appropriately programmed signal processor can extract heart rate, respiratory rate,
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`blood oxygen saturation (SpO2), and a variety of other physiological parameters.
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`Ex. 1012, § 3; Schwartz, Ex. 1018, 5:5-9, 10:7-20.
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`30. PPG had also found widespread use in pulse oximeters. A major
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`advance in the clinical use of PPG-based technology came with the introduction of
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`the pulse oximeter as a non-invasive method for monitoring patients’ arterial
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`oxygen saturation (SpO2). Ex. 1012, § 2.3; Ex. 1017, Preface. Oxygen saturation of
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`Inter Partes Review of
`U.S. Patent No. 8,652,040
`the hemoglobin in arterial blood is determined by the relative proportions of
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`oxygenated hemoglobin and reduced hemoglobin in the arterial blood. Pologe, Ex.
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`1020, 1:20-56; Ex. 1017, pp. 34-38. A pulse oximeter uses PPG signals to
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`determine the oxygen saturation of the hemoglobin by measuring the difference in
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`the light absorption of these two forms of hemoglobin. Ex. 1020, 1:20-56, FIG. 1
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`(displayed below).
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`31. The pulse oximeter typically includes a probe which contains two
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`light emitting diodes, one red and one infrared, and is placed in contact with the
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`skin. Ex. 1020, 1:20-56; Ex. 1017, pp. 34-38. There were conventionally two types
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`of probes for pulse oximetry: reflectance and transmittance. Ex. 1017, pp. 86-89.
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`FIGs. 7.1 and 7.2 from Webster have been provided below to illustrate the
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`differences between reflectance and