`Patent Owner Valencell, Inc.
`IPR2017-00319 and IPR2017-00321
`U.S. Patent No. 8,923,941
`
`United States Patent and Trademark Office
`Patent Trial and Appeal Board
`
`Administrative Patent Judges
`McNamara, Arpin, McShane
`Oral Argument – February 27, 2018
`
`
`
`U.S. Patent No. 8,923,941
`
`Filed: February 19, 2014
`
`Issued: December 30, 2014
`
`Title: Methods and Apparatus for
`Generating Data Output Containing
`Physiological and Motion-Related
`Information
`
`Inventors: Steven Francis LeBoeuf,
`Jesse Berkley Tucker, Michael
`Edward Aumer
`
`Claims: 1-21
`
`Independent Claims: 1 and 14
`
`IPR2017-00319, Ex. 1001 (“’941 patent”)
`
`
`
`The ’941 Patent
`
`
`
`The ’941 Patent Is Directed To Novel Methods and Systems
`for Generating a Serial Data Output Containing Both
`Physiological and Motion-Related Information.
`
`•
`
`The serial data output is created by a single monitoring device sensing
`physical activity through a motion sensor and physiological activity
`through a photoplethysmography (“PPG”) sensor. IPR 2017-00319, Paper 22 (“319 PO
`Response”) at 3, citing Ex. 1001 at 30:38-43.
`
`319 PO Response at 20.
`
`IPR2017-00319 and IPR2017-00321
`
`4
`
`
`
`The ’941 Patent Is Directed To Novel Methods and Systems
`for Generating a Serial Data Output Containing Both
`Physiological and Motion-Related Information.
`
`•
`
`The serial data output is configured such that a plurality of physiological
`parameters, including at least heart rate and respiration rate, are capable
`of being extracted from the physiological information obtained by a PPG
`sensor. 319 PO Response at 4.
`
`319 PO Response at 20.
`
`IPR2017-00319 and IPR2017-00321
`
`5
`
`
`
`The ’941 Patent Is Directed To Novel Methods and Systems
`for Generating a Serial Data Output Containing Both
`Physiological and Motion-Related Information.
`
`’941 Patent, Fig. 1
`
`•
`
`The apparatus claims are directed to a housing and a chipset enclosed
`within said housing containing a PPG sensor, motion sensor, and signal
`processor. The housing further comprises at
`least one window that
`optically exposes the PPG sensor to a body of the subject wearing the
`device. IPR 2017-00321, Paper 23 (“321 PO Response”) at 7, citing Ex. 1001 at 30:44-55.
`IPR2017-00319 and IPR2017-00321
`
`6
`
`
`
`The Alleged Grounds of Unpatentability
`
`
`
`The Instituted Grounds
`
`The 12 instituted grounds rely on 4 primary combinations. Because none of the 4
`primary combinations render the claims unpatentable, all 12 grounds fail.
`
`IPR2017-00321, Paper 11
`(“321 Institution Decision”) at 6.
`
`IPR2017-00319, Paper 10
`(“319 Institution Decision”) at 6-7.
`
`IPR2017-00319 and IPR2017-00321
`
`8
`
`
`
`Independent Method Claim 1
`
`
`
`Primary Reasons the 319 Petition Fails
`
`• Reason 1: Claim 1 Requires the Processor to Create a Serial Data
`Output, Which Luo and Craw Do Not Disclose
`
`• Reason 2: Luo Does Not Teach a Respiration Rate Extracted from a
`PPG Sensor
`
`• Reason 3: Mault Does Not Disclose That A Respiration Rate Can Be
`Extracted From Signals Obtained By a PPG Sensor
`
`• Reason 4: Mault Does Not Disclose A Single Monitoring Device
`Capable Of Sensing Both Heart Rate And Respiration Rate
`
`• Reason 5: Mault and Al-Ali Don’t Disclose Processing Signals from a
`Motion Sensor and PPG Sensor into a Serial Data Output of
`Physiological and Motion-Related Information
`
`IPR2017-00319 and IPR2017-00321
`
`10
`
`
`
`Petitioner Relies on Luo and Craw To Show the
`Unpatentability of Claim 1 in IPR2017-00319
`
`Luo discloses a “system and method for the wearable mini-size
`intelligent healthcare system, comprising one or multiple vital signal
`sensors, activity sensors, a real-time detection and analyzing module
`for continuous health monitoring … .”
`IPR2017-00319, Ex. 1055 at Abstract.
`
`Craw discloses that “methods and systems are provided
`for communicating between network devices.”
`IPR2017-00319, Ex. 1056 at Abstract.
`
`IPR2017-00319 and IPR2017-00321
`
`11
`
`
`
`Petitioner Separately Relies on Mault and Al-Ali To
`Show the Unpatentability of Claim 1 in IPR2017-00319
`
`Mault discloses a “diet and activity-monitoring device
`[that] includes a timer which outputs a time-indicative
`signal.”
`IPR2017-00319, Ex. 1057 at Abstract.
`
`Al-Ali discloses that a “sensor interface is configured
`to receive a sensor signal. A transmitter modulates a
`first baseband signal responsive to the sensor signal
`so as to generate a transmit signal.”
`IPR2017-00319, Ex. 1058 at Abstract.
`
`IPR2017-00319 and IPR2017-00321
`
`12
`
`
`
`Reason 1: Claim 1 Requires the Processor to Create a
`Serial Data Output, Which Luo and Craw Do Not Disclose
`
`• Claim 1 requires that a processor create a serial data output.
`
`IPR2017-00319 and IPR2017-00321
`
`319 PO Response at 18.
`
`13
`
`
`
`Claim 1 Requires the Processor to
`Create a Serial Data Output
`
`• Figure 17 shows how signals from optical detectors 26 and
`optical emitters 24 are transmitted through a digital bus 600 to a
`processor 602, which processes those signals into multiple data
`outputs in serial format 604.
`
`IPR2017-00319 and IPR2017-00321
`
`319 PO Response at 19-20.
`
`14
`
`
`
`Claim 1 Requires the Processor to
`Create a Serial Data Output
`
`illustrates the serial data output of
`• Figure 18 further
`physiological and motion-related (activity) information parsed
`out so that an API can utilize them for particular applications.
`
`IPR2017-00319 and IPR2017-00321
`
`319 PO Response at 19-20.
`
`15
`
`
`
`Luo and Craw Only Teach the Transmission of Serialized
`Data, Not the Creation of a Serial Data Output
`• Luo and Craw only disclose ways of accomplishing the
`transmission of the data output in serial format and not its
`creation via a processor. Mere transmission of data is shown in
`Fig. 17 via the output bus 606, but that does illustrate the
`requirement of the creation of the serial data output 604 via the
`processor.
`
`• Petitioner incorrectly asserts Luo’s teaching of the transmission
`of data via a serial device such as a USB port is the same as the
`processing of signal data into a serial data output.
`
`• Likewise, Craw does not teach that heart rate or respiration rate
`are able to be extracted after processing signals. Rather, Craw
`merely teaches that data already containing heart rate and
`respiration rate can be transmitted serially.
`
`319 PO Response at 19-23.
`
`IPR2017-00319 and IPR2017-00321
`
`16
`
`
`
`Petitioner’s Expert’s Option Is Not Credible
`
`• Dr. Sarrafzadeh would not go into further detail when asked
`about whether USB transmission alone would satisfy this claim
`element. Instead, he either read his report in this record or made
`conclusory assertions, as show below:
`
`319 PO Response at 22.
`
`Exhibit 2007, 126:7-19.
`
`IPR2017-00319 and IPR2017-00321
`
`17
`
`
`
`Reason 2: Luo Does Not Teach a Respiration Rate
`Extracted from a PPG Sensor
`
`• Claim 1 requires “sensing … physiological information ... via a
`single monitoring device … wherein the monitoring device
`comprises … at least one photoplethysmography (PPG) sensor
`for sensing the physiological
`information; and processing
`signals … from the at least one PPG sensor via a processor of
`the monitoring device into a serial data output of physiological
`information … wherein the serial data output is configured such
`that a plurality of subject physiological parameters comprising
`subject heart rate and subject respiration rate can be extracted
`from the physiological information … .” IPR2017-00319, Ex. 1001, 30:35-54
`
`IPR2017-00319 and IPR2017-00321
`
`18
`
`
`
`Claim 1 Requires That Signals From a PPG Sensor Must Be
`Processed Into An Output From Which
`Respiration Rate Can Be Extracted
`
`information
`“Thus, claim 1 provides that the physiological
`may be sensed by ‘at least one’ (i.e., one or more) PPG
`sensors and that the ‘signals,’ which are processed into the
`serial data output from which the physiological parameters
`‘comprising subject heart rate and subject respiration rate can
`be extracted,’ are received ‘from at least one’ (i.e., one or
`more) PPG sensors.” 319 Institution Decision, Paper 10 at 22.
`
`• Accordingly, the respiration rate must thus be capable of
`extraction from the physiological information based on the
`processing of signals obtained by only a PPG sensor.
`
`319 PO Response at 15.
`
`IPR2017-00319 and IPR2017-00321
`
`19
`
`
`
`Luo Does Not Teach Signals From a PPG Sensor Being
`Processed to Output a Respiration Rate.
`
`• Luo’s only references to respiration rate are found in claims 37
`and 51, which describe that a “processing module is configured
`to process the physiological, activity and environmental
`variables to determine a respiratory rate and the output signal is
`based on the respiratory rate.”
`
`319 PO Response at 16.
`
`• Claim 1 requires that physiological information processed from
`a PPG sensor be processed into an output
`from which
`respiratory rate can be extracted.
`
`319 PO Response at 16.
`
`• Luo, on the other, discloses processing signals from the
`physiological, activity and environmental variables to output a
`respiratory rate. Necessarily, Luo teaches that signals other
`than PPG signals are processed to output a respiration rate.
`
`319 PO Response at 16-17.
`
`IPR2017-00319 and IPR2017-00321
`
`20
`
`
`
`There Was No Motivation to
`Combine Luo and Craw
`
`• Luo is directed to a wearable system for monitoring and
`analyzing the health status of a user.
`Its system is self-
`contained and it
`is not concerned with communicating
`physiological parameters between devices.
`
`• Craw is concerned with a specific data formatting scheme to
`address interoperability between devices.
`
`• Since Craw does not process signal data, but instead merely
`formats end-result data, there would have been no motivation to
`combine Craw with Luo’s sensor-driven system.
`
`319 PO Response at 24-26.
`
`IPR2017-00319 and IPR2017-00321
`
`21
`
`
`
`Reason 3: Mault Does Not Disclose That A Respiration Rate
`Can Be Extracted From Signals Obtained By A PPG Sensor
`
`• As discussed in Reason 2, the physiological information must
`be sensed by a PPG sensor, and respiration rate must be
`capable of extraction from the physiological information based
`on the processing of signals obtained by a PPG sensor.
`
`• Although Mault references a PPG sensor in a wristwatch-style
`device to determine heart rate, Mault does not teach the use of a
`PPG sensor to determine respiration rate.
`
`•
`
`Instead, Mault discloses separate embodiments for determining
`a respiration rate such as a chest strap, ultrasonic sensing, and
`a flow meter.
`
`319 PO Response at 26-27, 30-32
`
`IPR2017-00319 and IPR2017-00321
`
`22
`
`
`
`Mault Only Discusses PPG Sensors in the Context of
`Determining Heart Rate, Not Respiration Rate
`
`• None of Mault’s methods for determining respiration rate can be
`considered a PPG sensor and Petitioner does not claim
`otherwise.
`
`319 PO Response at 26, 32.
`
`•
`
`Instead, Petitioner argues only that “Mault also discloses
`processing signals from the PPG sensor (i.e., the heart rate
`sensor) to determine heart rate.”
`
`319 Petition, Paper 2 at 50.
`
`• This is insufficient to show that Mault teaches a respiration rate
`derived from physiological information that is sensed by a PPG
`sensor.
`
`319 PO Response at 30-32.
`
`IPR2017-00319 and IPR2017-00321
`
`23
`
`
`
`Reason 4: Mault Does Not Disclose A Single Monitoring
`Device Capable Of Sensing Both Heart Rate And
`Respiration Rate
`• Claim 1 requires “sensing physical activity and physiological
`information from a subject via a single monitoring device
`attached to the subject”.
`
`319 PO Response at 28.
`
`• Petitioner’s Expert testified that Mault’s disclosed respiration
`sensor was separate from the PPG sensor and motion sensor.
`
`319 PO Response at 30.
`
`IPR2017-00319 and IPR2017-00321
`
`24
`
`Exhibit 2007, 128:3-12.
`
`
`
`Each Of Mault’s Proposed Methods for Sensing a Respiration Rate
`Uses a Separate Physical Device from the Embodiments that
`Teach a Wristwatch PPG Sensor
`
`319 PO Response at 29-30.
`
`IPR2017-00319 and IPR2017-00321
`
`25
`
`
`
`Reason 5: Mault and Al-Ali Don’t Disclose Processing Signals from a
`Motion Sensor and PPG Sensor into a Serial Data Output of
`Physiological and Motion-Related Information
`
`• Claim 1 requires “processing signals from the at least one
`motion sensor and signals from the at least one PPG sensor via
`a processor of the monitoring device into a serial data output of
`physiological information and motion-related information.”
`
`• Petitioner alleges that Mault teaches processing signals from a
`motion sensor and that Al-Ali teaches processing physiological
`signals into a serial data output of physiological information.
`
`the combination teaches
`• Petitioner does not argue that
`processing signals from a motion sensor and PPG sensor into a
`serial data output of physiological
`and motion-related
`information.
`
`319 PO Response at 33-34.
`
`IPR2017-00319 and IPR2017-00321
`
`26
`
`
`
`Even if Taken as True, Petitioner’s
`Conclusory Statements Do Not Demonstrate That
`Mault and Al-Ali Teach This Element
`
`that “it would have been
`• Petitioner’s conclusory statement
`obvious to combine the teachings of Mault and Al-Ali to process
`signals from Mault’s motion sensor and PPG sensor into a
`serial data output” does not demonstrate that Mault and Al-Ali
`teach processing motion sensor and PPG sensor signals into a
`serial data output of physiological
`and motion-related
`information.
`
`319 PO Response at 34-35.
`
`•
`
`Instead, this conclusory statement only shows, at most, that
`Mault and Al-Ali disclose the creation of a generic serial data
`output, not a serial data output of physiological and motion-
`related information.
`
`319 PO Response at 35.
`
`IPR2017-00319 and IPR2017-00321
`
`27
`
`
`
`No Motivation to Combine Mault and Al-Ali
`
`• Mault is directed to a device that monitors the diet and activity
`of a person. Unrelatedly, Al-Ali
`is merely directed to a
`modulation technique that allows for
`information to be
`wirelessly transmitted between a sensor and a monitor.
`
`• Al-Ali would not have solved any problem presented by Mault,
`because Mault already contemplated both wired and wireless
`versions of its invention, and the specification did not prefer
`one over the other.
`
`319 PO Response at 36-37.
`
`IPR2017-00319 and IPR2017-00321
`
`28
`
`
`
`Independent Apparatus Claim 14
`
`
`
`Primary Reasons the 321 Petition to Demonstrate
`that Apparatus Claim 14 is Unpatentable
`
`• Reason 1: Kosuda Does Not Disclose a Chipset
`Comprising a PPG Sensor Enclosed Within a Housing
`
`• Reason 2: Petitioner Proposed Motivations to
`Combine Kosuda and Maekawa Should Be Rejected
`
`• Reason 3: Aceti Does Not Disclose A Housing
`Enclosing A Chipset And Comprising A Window
`
`IPR2017-00319 and IPR2017-00321
`
`30
`
`
`
`Petitioner Relies on Kosuda and Maekawa To Show the
`Unpatentability of Claim 14 in IPR2017-00321
`
`body
`the
`removing
`“surely
`discloses
`Kosuda
`movement component generated in a living organism
`from a pulse wave component.”
`IPR2017-00321, Ex. 1027 at Abstract.
`
`IPR2017-00319 and IPR2017-00321
`
`31
`
`IPR2017-00321, Ex. 1030
`
`
`
`Petitioner Separately Relies on Aceti and Fricke To
`Show the Unpatentability of Claim 14 in IPR2017-00321
`
`for
`apparatus
`and
`“[m]ethods
`discloses
`Aceti
`monitoring at least one physiological parameter of an
`animal from one or more physiological characteristics
`present within an auditory canal of the animal.”
`IPR2017-00321, Ex. 1031 at Abstract.
`
`Fricke discloses a “signal processing module [that] is
`configured to process the electric signal using a
`nonstationary frequency estimation method to obtain
`a processed signal related to at least one of a heart
`rate and a respiration rate of the patient.”
`IPR2017-00321, Ex. 1016 at Abstract
`
`IPR2017-00319 and IPR2017-00321
`
`32
`
`
`
`Reason 1: Kosuda Does Not Disclose a Chipset
`Comprising a PPG Sensor Enclosed Within a Housing
`
`• Petitioner, in its arguments on this claim element, contends that
`the “housing” is comprised of watchcase 10A and back lid 14.
`• Petitioner’s expert testifies that transparent glass 13C is not
`part of the housing.
`
`321 PO Response at 16-17.
`IPR2017-00319 and IPR2017-00321
`
`33
`
`
`
`Kosuda’s PPG Sensor is on
`the Bottom of the Housing
`
`• Petitioner also contends the PPG sensor is comprised of at
`least Light Emitting Diode 13A and Photodetector 13B.
`
`321 PO Response at 16-17.
`IPR2017-00319 and IPR2017-00321
`
`34
`
`
`
`Housing 10A and Back Lid 14
`Do Not Enclose the PPG Sensor
`
`•
`
`Petitioner’s own argument is that the housing is comprised of 10A and 14,
`which does not enclose the PPG sensor 13A and 13B. The PPG sensor is
`attached to the back of the watchcase or back lid. In its argument on this claim
`element, Petitioner never contends that the transparent glass 13C is part of the
`housing.
`
`• Because the PPG sensor itself is not enclosed within the housing that Petitioner
`suggests, a chipset comprising a PPG sensor also cannot be enclosing within
`the housing.
`321 PO Response at 16-18.
`IPR2017-00319 and IPR2017-00321
`
`35
`
`
`
`Reason 2: Petitioner Proposed Motivations to Combine
`Kosuda and Maekawa Should Be Rejected
`
`• Claim 14 requires “non-air light transmissive material in optical
`communication with the at
`least one PPG sensor and the
`window.”
`
`’941 Patent, 32:11-14.
`
`• Petitioner concedes that Kosuda “does not explicitly state that a
`non-air light transmissive material exists between sensor 13
`and transparent glass 13C.”
`
`321 PO Response at 19.
`
`• Thus, Petitioner combines Kosuda with Maekawa in an attempt
`to demonstrate this disclosure. 321 PO Response at 19-20.
`
`IPR2017-00319 and IPR2017-00321
`
`36
`
`
`
`Petitioner Did Not Offer Proper
`Motivations To Combine Kosuda And Maekawa
`
`• However, Petitioner has not demonstrated the use of a known
`technique in Maekawa that would improve the signal-to-noise
`ratio of
`the device in Kosuda.
`In fact,
`the disclosures of
`Maekawa would worsen the signal-to-noise ratio of the pulse
`signal. Accordingly, Petitioner has not made of a prima facie
`case of obviousness with regard to Kosuda and Maekawa.
`
`• “To make a prima facie case, the prior art must provide, and the
`Board must identify, a reason or motivation to depart from the
`prior art … .” In re Efthymiopoulos, 839 F.3d 1375, 1381 (Fed.
`Cir. 2016)
`
`321 PO Response at 18-19.
`
`IPR2017-00319 and IPR2017-00321
`
`37
`
`
`
`Maekawa’s Solution Would Worsen
`the Signal To Noise Ratio
`
`• Placing Maekawa’s non-air light transmissive material (such as
`an optical fiber) in optical communication with Kosuda’s PPG
`sensor (i.e., pulse wave sensor 13) and window (i.e., transparent
`glass 13C), as Petitioner suggested, would worsen the signal-to-
`noise ratio.
`
`321 PO Response at 21-23.
`
`IPR2017-00319 and IPR2017-00321
`
`38
`
`
`
`Light From Emitter 4 Gets Trapped
`in Glass 23 Before Entering Detector 5
`
`• Light would become trapped in the glass window, and enter
`the physiological detector containing no physiological data
`and all noise. Maekawa contemplates this very possibility.
`The blue arrows show light entering the detector directly from
`the window. Such light would be all noise.
`
`321 PO Response at 21-23.
`
`IPR2017-00319 and IPR2017-00321
`
`39
`
`
`
`Solving Kosuda’s Signal-to-Noise Problem Could Be More
`Easily Accomplished without Maekawa’s Disclosures
`
`• A POSA would readily recognize that moving the LED 4 and
`detector PD 5 farther apart would be a much simpler, easier, and
`cheaper way of ensuring that more light penetrates the skin
`deeply and that less light enters the skin only superficially.
`
`321 PO Response at 24.
`
`• Petitioner’s expert was
`unwilling or unable to
`answer questions about
`this alternative solution:
`
`Exhibit 2011, 152:7-24.
`
`IPR2017-00319 and IPR2017-00321
`
`40
`
`
`
`Reason 3: Aceti Does Not Disclose A Housing
`Enclosing A Chipset And Comprising A Window
`
`• Claim 14 requires “a housing” that must (1) enclose a chipset,
`(2) comprise at least one window, and (3) comprise non-air light
`transmissive material. All of these elements must be included in
`the same housing.
`See ’941 patent, 32:1-15 (“a chipset enclosed with the housing,”
`“where the housing comprises at least one window … ,” “wherein the
`housing comprises non-air light transmissive material ….”)
`
`• Contrary to Petitioner’s contention, the housing 106 and cover
`108 are one housing, and the conductor portion 104 with end
`112 is a separate piece. Indeed, the swiveling arm 104 would
`simply not function if it were not a separate piece from the
`housing 106.
`
`321 PO Response at 29-30.
`
`IPR2017-00319 and IPR2017-00321
`
`41
`
`
`
`Elements Highlighted Red are Part of a Separate
`Housing From Those Highlighted Blue
`
`321 PO Response at 31.
`
`IPR2017-00319 and IPR2017-00321
`
`42
`
`
`
`Aceti’s Conductor Portion is
`Removably Coupled to the Processor Portion
`
`• Aceti further confirms that conductor portion 104 is a
`separate piece from housing 106 and cover 108 when
`it says that “conductor portion 104 is removably
`coupled to the processor portion 102 and is
`considered disposable.”
`
`321 PO Response at 31.
`
`IPR2017-00319 and IPR2017-00321
`
`43
`
`
`
`Aceti’s Window Does Not
`Cover, Enclose, Support, or Protect
`
`• Additionally, the optically transparent elastomer “window” 408,
`located at
`the end of
`the conductor 104, does not cover,
`enclose, support, or protect any of the electronic components,
`and is not made of the same material as conductor 104 and case
`106.
`
`321 PO Response at 31-32.
`
`IPR2017-00319 and IPR2017-00321
`
`44
`
`
`
`Aceti Discloses that Window 408 Uses
`Different Materials and Has a Different Function
`
`• Aceti notes that the “first end 112 is configured for comfort,
`biocompatibility, durability, and ease of manufacture. Suitable
`materials for use within the first end 112 include acrylic, vinyl,
`silicone, or polyethylene, for example.”
`
`• Given the window’s different materials and function, a POSA
`would have considered elastomer window 408 to comprise a
`different housing or to sit atop the housings comprised of
`housing 106 and conductor 104.
`
`321 PO Response at 32.
`
`IPR2017-00319 and IPR2017-00321
`
`45
`
`
`
`End of Demonstrative Presentation
`
`