`
`Filed on behalf of Valencell, Inc.
`By:
`Justin B. Kimble (JKimble-IPR@bcpc-law.com)
`
`Nicholas C. Kliewer (nkliewer@bcpc-law.com)
`
`Jonathan H. Rastegar (jrastegar@bcpc-law.com)
`
`Bragalone Conroy PC
`
`2200 Ross Ave.
`
`Suite 4500 – West
`
`Dallas, TX 75201
`
`Tel: 214.785.6670
`
`Fax: 214.786.6680
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD 
`
`APPLE INC.,
`Petitioner,
`
`v.
`
`VALENCELL, INC.,
`Patent Owner.
`
`Case IPR2017-00319
`U.S. Patent No. 8,923,941
`
`
`PATENT OWNER’S RESPONSE
`
`
`
`Mail Stop PATENT BOARD
`Patent Trial and Appeal Board
`U.S. Patent & Trademark Office
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`
`
`
`
`
`

`

`
`
`Table of Contents
`
`
`Introduction ....................................................................................................... 1
`I.
`II. Overview of the ’941 Patent ............................................................................. 3
`III. Claim Construction ........................................................................................... 7
`A.
`Legal Principles ..................................................................................... 7
`B.
`“PPG sensor” should be construed as “an optical sensor which obtains
`a plethysmogram that results from blood flow modulations caused by
`the subject’s heartbeat” ......................................................................... 8
`IV. Grounds 1-5 fail because Petitioner cannot meet its burden to establish the
`combination of Luo and Craw renders claims 1, 2, and 6-13 obvious. ............ 9
`A.
`Luo and Craw do not relate to the same technology and do not attempt
`to solve the same problems. ................................................................ 10
`1. Luo does not process sensor signals into a serial data output.. 10
`2. Craw is directed to a specific data formatting scheme to address
`interoperability between medical devices. ................................ 13
`Neither Luo nor Craw discloses that respiration rate can be extracted
`from signals obtained by a PPG sensor. .............................................. 14
`Neither Luo nor Craw discloses elements [1.4] and [1.5], and a POSA
`would not have been motivated to combine Luo and Craw to render
`disclosures obvious.............................................................................. 18
`1. Luo does not disclose the processing of signals into a serial data
`output of physiological information and motion-related
`information. ............................................................................... 21
`2. Craw also does not disclose the processing of signals into a
`serial data output of physiological information and motion-
`related information. ................................................................... 22
`
`B.
`
`C.
`
`
`
`i
`
`

`

`
`
`D.
`
`3. Luo and Craw cannot be combined to render “processing
`signals” limitation obvious. ...................................................... 24
`A POSA would not have been motivated to combine Luo and Craw
`because they are not directed to similar physiological monitoring
`devices. ................................................................................................ 24
`V. Grounds 6-11 fails because Petitioner fails to meet its burden to establish that
`Mault in view of Al-Ali renders claims 1, 2, and 6-13 obvious. .................... 26
`A. Mault and Al-Ali describe entirely different technologies which solve
`completely different problems. ........................................................... 26
`1. Mault does not disclose a single monitoring device containing a
`PPG sensor capable of processing signals from which a
`respiration rate may be derived. ................................................ 26
`2. Al-Ali is directed to a communications adapter that is
`compatible with existing sensors and monitors and that creates
`a wireless link replacement for traditional cable. ..................... 27
`Neither Mault nor Al-Ali discloses a single monitoring device capable
`of sensing both heart rate and respiration rate data. ............................ 28
`Neither Mault nor Al-Ali discloses a PPG sensor capable of having its
`signals processed to produce a serial data output from which
`respiration rate can be extracted. ......................................................... 30
`Neither Mault nor Al-Ali discloses the step of “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.” ....................................................................................... 33
`A POSA would not have had a reason to combine Mault with
`Al-Ali. .................................................................................................. 36
`
`B.
`
`C.
`
`D.
`
`E.
`
`
`
`ii
`
`

`

`
`
`VI. The dependent claims fail because Petitioner has not met its burden of
`showing that the independent claim from which they depend is obvious. ..... 38
`VII. Patent Owner does not consent to the PTAB adjudicating the patentability or
`validity of the ’941 patent. .............................................................................. 38
`VIII. Conclusion ...................................................................................................... 39
`
`
`
`
`iii
`
`

`

`
`
`2002
`
`PATENT OWNER’S EXHIBIT LIST
`
`
`Exhibit No. Description
`2001
`S. LeBoeuf, et al., Earbud-Based Sensor for the Assessment of
`Energy Expenditure, HR, and VO2max, OFFICIAL J. AM. C.
`SPORTS M., 2014, 1046–1052
`Biometrics Lab: Performance of Leading Optical Heart Rate
`Monitors During Interval Exercise Conditions
`Valencell website (http://valencell.com/customers/)
`CTA - It Is Innovation (i3) Magazine 2016 Innovation-
`Entrepreneur Awards
`Declaration of T. William Kennedy - PHV Motion
`Declaration of Luca Pollonini
`Deposition of Majid Sarrafzadeh
`
`2003
`2004
`
`2005
`2006
`2007
`
`
`
`iv
`
`

`

`
`
`
`
`I.
`
`Introduction
`
`Claims 1, 2, and 6-13 of U.S. Patent No. 8,923,941 (the “’941 patent”) owned
`
`by Valencell, Inc. (“Patent Owner”) cover novel systems and methods for generating
`
`a serial data output using both a photoplethysmographic (“PPG”) sensor as well as
`
`another physical sensor. The ’941 patent teaches using the sensors to filter and output
`
`useful physical and physiological data that can subsequently be parsed for further
`
`analysis by an application-specific interface. These were novel advancements in the
`
`art, and Petitioner Apple Inc. (“Petitioner”) has not met its burden to prove that either
`
`of the two proposed primary combinations render the challenged claims obvious. As
`
`such, all eleven instituted grounds fail.
`
`Grounds 1-5 fail because the proposed combination of U.S. Patent
`
`Application Publication No. 2008/0200774 (“Luo”) and U.S. Patent Application
`
`Publication No. 2008/0133699 (“Craw”) suffers from at least three defects, each of
`
`which is fatal to Petitioner’s argument of unpatentability of claim 1 and all the
`
`instituted claims that depend from it.
`
`First, neither Luo nor Craw discloses a PPG sensor that captures signals that
`
`are processed into a serial data output from which a respiration rate can be extracted.
`
`Second, neither Luo nor Craw discloses or renders obvious the claimed step
`
`of “processing signals from the at least one motion sensor and signals from the at
`
`1
`
`
`
`
`
`

`

`
`
`least one PPG sensor via a processor of the monitoring device into a serial data
`
`output of physiological information and motion-related information.” Petitioner
`
`ignores the complexity of the claimed “serial data output” and instead incorrectly
`
`equates this essential part of the invention to little more than a distinction between
`
`two conventional ways to transmit data. But the “serial data output of physiological
`
`information and motion-related information” is not disclosed by either Luo or Craw,
`
`as neither reference discloses the creation of the serial data output from the signals
`
`obtained by the sensors, as required by the ’941 patent.
`
`Third, in light of the disclosures of Luo and Craw, a person of ordinary skill
`
`(“POSA”) would not have had a motivation to combine the two references, because
`
`Luo’s contemplated sensor system is complete on its own and would not have
`
`benefitted from Craw’s “interoperability” protocols.
`
`Grounds 6-11 fail because the proposed combination of U.S. Patent No.
`
`6,513,532 (“Mault”) and U.S. Patent Application Publication No. 2003/0181798
`
`(“Al-Ali”) contains at least four defects that result in a failure of this combination to
`
`disclose or render obvious claim 1 of the ’941 patent and the instituted dependent
`
`claims.
`
`First, neither Mault nor Al-Ali discloses a single monitoring device capable
`
`of sensing physiological information comprising both heart rate and respiration rate.
`
`
`
`2
`
`

`

`
`
`Second, neither Mault nor Al-Ali discloses a PPG sensor from which a
`
`respiration rate can be extracted after processing the PPG sensor’s signals.
`
`Third, the combination of Mault and Al-Ali fails to disclose or render obvious
`
`the limitation of “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.”
`
`Fourth, a POSA would not have had any motivation to combine these two
`
`pieces of prior art in the first place because Al-Ali’s modulation technique for
`
`allowing wireless transmissions between a sensor and monitor would not solve any
`
`problem posed by Mault, as Mault already expressly contemplates various forms of
`
`wireless transmission.
`
`Because of these failings of the proposed combinations, Petitioner has not
`
`satisfied its burden to demonstrate that the instituted claims of the ’941 patent are
`
`unpatentable as obvious over the asserted art.
`
`II. Overview of the ’941 Patent
`The ’941 Patent is generally directed to a novel method and system for
`
`generating data output containing both physiological and motion-related
`
`information. See, e.g., Ex. 1001 (the “’941 patent”), 30:35-37. This data output is
`
`created by a single monitoring device sensing physical activity through a motion
`
`sensor and physiological activity through a photoplethysmography (“PPG”) sensor.
`
`
`
`3
`
`

`

`
`
`See id., 30:38-43. The signals obtained from these sensors are then processed into a
`
`serial data output. See id., 30:44-54. Said serial data output is configured such that a
`
`plurality of both physical and physiological parameters, including at least heart rate
`
`and respiration rate, are capable of being extracted from the physiological and
`
`motion-related information obtained by the sensors. See id.
`
`An important limitation on the physiological data that can be extracted is that
`
`such data must come from signals obtained by a PPG sensor. See id. (“processing
`
`signals … from the at least one PPG sensor … into a serial data output … 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
`
`…”). This language, combined with the language in the first element of the claim
`
`(“at least one photoplethysmography (PPG) sensor for sensing the physiological
`
`information …”), makes clear that any signals that are processed to output
`
`“physiological parameters” must be sensed by at least one PPG sensor. No other type
`
`of sensor will suffice to meet the limitations of the claim, and, accordingly, both
`
`heart rate and respiration rate must be able to be extracted through processing signals
`
`obtained by one or more PPG sensors. See Exhibit 2006, Declaration of Luca
`
`Pollonini ¶ 42 (“Pollonini Decl.”).
`
`The ’941 patent contains several inventive aspects related to its creation of a
`
`data output containing physiological and motion-related information. As shown in
`
`
`
`4
`
`

`

`
`
`the annotation to Fig. 17 below, the ’941 patent teaches how to pull multiple metrics
`
`from a single device and serialize such information so that it can readily be used by
`
`outside APIs. See Pollonini Decl. ¶ 43.
`
`
`
`As the specification of the ’941 patent states, “FIG. 17 is a block diagram that
`
`illustrates sensor signals being processed into a digital data string including activity
`
`data and physiological data using the method 500 of FIG. 16 … .” ’941 patent, 26:65-
`
`
`
`
`
`5
`
`

`

`
`
`67. Figure 16 essentially shows the signal data being cleaned up to produce more
`
`accurate parameters prior to being processed into the serial data output:
`
`
`
`’941 patent, Fig. 16.
`
`
`
`Furthermore, as shown in Figure 17 above and explained in the specification,
`
`multiple data outputs can be generated through the processor: “Optical detectors 26
`
`and optical emitters 24 may include digitizing circuitry such that they may be
`
`connected serially to a digital bus 600. Data from the detectors 26 may be processed
`
`by a processor/multiplexer 602 to generate multiple data outputs 604 in a serial
`
`format at the output 606 of the processor 602.” ’941 patent, 26:2-14. “The processor
`
`602 may execute one or more serial processing methods, wherein the outputs of a
`
`plurality of processing steps may provide information that is fed into the multiplexed
`
`data outputs 604.” Id. All of this results in “a serial data string of activity and
`
`physiological information 700 (FIG. 18) parsed out specifically such that an
`
`
`
`6
`
`

`

`
`
`application-specific interface (API) can utilize the data as required for a particular
`
`application,” id., 26:15-20, as shown above in the annotated Figure 18.
`
`Thus, the method claims of the ’941 patent are directed to the process of
`
`generating a data output by pulling multiple metrics from a single device’s sensors
`
`in a serialized manner such that said data output can be easily implemented and used
`
`by mobile applications.
`
`III. Claim Construction
`A. Legal Principles
`In an inter partes review, “[a] claim in an unexpired patent … shall be given
`
`its broadest reasonable construction in light of the specification of the patent in
`
`which it appears.” 37 C.F.R. § 42.100(b); see Cuozzo Speed Techs., LLC v. Lee, 136
`
`S. Ct. 2131, 2142 (2016). “Under a broadest reasonable interpretation, words of the
`
`claim must be given their plain meaning, unless such meaning is inconsistent with
`
`the specification and prosecution history.” Trivascular, Inc. v. Samuels, 812 F.3d
`
`1056, 1062 (Fed. Cir. 2016). “That is not to say, however, that the Board may
`
`construe claims during IPR so broadly that its constructions are unreasonable under
`
`general claim construction principles. … ‘[T]he protocol of giving claims their
`
`broadest reasonable interpretation ... does not include giving claims a legally
`
`incorrect interpretation.’” Microsoft Corp. v. Proxyconn, Inc., 789 F.3d 1292, 1298
`
`(Fed. Cir. 2015) (internal citations omitted) (emphasis in original). “Even under the
`
`
`
`7
`
`

`

`
`
`broadest reasonable interpretation, the Board's construction ‘cannot be divorced
`
`from the specification and the record evidence,’ and ‘must be consistent with the one
`
`that those skilled in the art would reach.’” Id. (internal citations omitted). “While the
`
`broadest reasonable interpretation standard is broad, it does not give the Board an
`
`unfettered license to interpret the words in a claim without regard for the full claim
`
`language and the written description.” Trivascular, Inc. v. Samuels, 812 F.3d
`
`1056, 1062 (Fed. Cir. 2016) (internal citations omitted) (emphasis added).
`
`“Construing individual words of a claim without considering the context in which
`
`those words appear is simply not ‘reasonable.’” Id.
`
`B.
`
`“PPG sensor” should be construed as “an optical sensor which
`obtains a plethysmogram that results from blood flow modulations
`caused by the subject’s heartbeat.”
`
`The Board adopted Patent Owner’s proposed construction of “PPG sensor”
`
`from the related IPR2017-00321 case: “an optically obtained plethysmogram that
`
`results from blood flow modulations caused by the subject’s heartbeat.” Because the
`
`present proceeding relates to the same patent, the Board also preliminarily adopted
`
`said construction in the present case. See Apple Inc. v. Valencell, Inc., Case IPR2017-
`
`00319 (PTAB 2017) (Paper 10) (“Institution Decision”). Patent Owner submits that
`
`a slight amendment to the preliminary construction is required to reflect the fact the
`
`sensor is the claim element in question, not the result produced by the sensor.
`
`Accordingly, Patent Owner therefore requests that the construction of PPG sensor
`
`
`
`8
`
`

`

`
`
`be amended to “an optical sensor which obtains a plethysmogram that results from
`
`blood flow modulations caused by the subject’s heartbeat.”
`
`IV. Grounds 1-5 fail because Petitioner cannot meet its burden to establish
`the combination of Luo and Craw renders claims 1, 2, and 6-13 obvious.
`
`Petitioner’s proposed combination of Luo and Craw does not render claims 1,
`
`2, and 6-13 obvious because those references fail to disclose claim elements [1.4]
`
`and [1.5]. Thus, Petitioner’s prima facie case of obviousness fails because it cannot
`
`identify key features of the claims of the ’941 patent in its prior art. See
`
`Intercontinental Great Brands LLC v. Kellogg N. Am. Co., 118 F. Supp. 3d 1022,
`
`1028 (N.D. Ill. 2015), aff'd, No. 2015-2082, 2017 WL 3906853 (Fed. Cir. Sept. 7,
`
`2017) (“A prima facie case of obviousness is established if the prior art references
`
`‘[i]n combination ... teach all of the limitations of the claims’ and a person of
`
`ordinary skill in the art would combine the elements to create the invention.”)
`
`(quoting Transocean Offshore Deepwater Drilling, Inc. v. Maersk Contractors USA,
`
`Inc., 617 F.3d 1296, 1303–04 (Fed. Cir. 2010)).
`
` A claim is obvious if “the differences between the subject matter sought to
`
`be patented and the prior art are such that the subject matter as a whole would have
`
`been obvious at the time the invention was made to a person having ordinary skill in
`
`the art to which said subject matter pertains.” KSR Intern. Co. v. Teleflex Inc., 550
`
`U.S. 398, 406 (2007). When combining references, a petitioner must “show[] how
`
`the prior art renders obvious any particular claim, as a whole, being challenged.”
`9
`
`
`
`

`

`
`
`Apple, Inc. v. ContentGuard Holdings, Inc., No. IPR2015-00358, 2015 WL
`
`9899010, at *6 (PTAB July 2, 2015) (emphasis in original).
`
` Further, “Petitioner must show some reason why a person of ordinary skill in
`
`the art would have thought to combine particular available elements of knowledge,
`
`as evidenced by the prior art, to reach the claimed invention.” Heart Failure Tech.
`
`v. Cardiokinetix, Inc., No. IPR2013-00183, Paper 12 at 9 (PTAB July 31, 2013)
`
`(emphasis added). Petitioner has not shown how or why a POSA would have thought
`
`to combine the prior art references, which are directed to different technology and
`
`solve different problems, with an “articulated reasoning with some rational
`
`underpinnings.” KSR, 550 U.S. at 418 (internal citation and quotation marks
`
`omitted). For at least the foregoing reasons, Petitioner’s Ground 1 fails, and, because
`
`Grounds 3-5 are directed to claims that depend from claim 1, those grounds also fail.
`
`A. Luo and Craw do not relate to the same technology and do not
`attempt to solve the same problems.
`
`1.
`
`Luo does not process sensor signals into a serial data output.
`
`Luo discloses a wearable device for continuous health monitoring of a user.
`
`See generally Luo, Abstract, Ex. 1055. Luo specifically discloses a system
`
`configured around the user’s ear for detecting physiological information and activity
`
`information of the use. See id. ¶ 25. Luo’s system detects physiological conditions
`
`“such as oxyhemoglobin saturation (SpO2), body temperature or even glucose,”
`
`through the use of “[a] red light (with 660 nm wavelengths) and infrared light (with
`
`
`
`10
`
`

`

`
`
`910 nm wavelengths) [which] are emitted through the earlobe by light sources of
`
`sensor unit (S1) and [] us[ing] optoelectronic sensors to detect the amount of light
`
`reflected back from the reflection plate, in which lights have gone through the
`
`earlobe twice by reflection.” Id. ¶ 28. Luo further discloses that “intelligent detection
`
`algorithm extracts heart rate, blood flow information or even sleep apnea when the
`
`subject is in sleep.” Id. This “detection algorithm continuously monitors the subject's
`
`physiological signals, extracts its pattern, predicts the trend of the physiological
`
`condition and analyze the physiological condition according to the medical expert
`
`knowledge and the subject's own health history.” Id.
`
`Using the activity and physiological signals that the sensors purportedly
`
`produce, Luo discloses that “[i]f a concerned health state is detected, the system will
`
`emit smart audio outputs to alert or remind the subject for the concerned health
`
`condition. If a serious or dangerous health state is detected, the intelligent healthcare
`
`system will both emit the smart audio outputs to the subject and request, via the short
`
`range RF link, the PDA or cell phone to contact the health center, doctor or family
`
`member through the available wireless communication network.” Id. ¶ 30. Examples
`
`of such output actions include “emergency call/transmission (page or phone call)
`
`through RF 44 for a very serious condition, activation of the smart audio outputs
`
`such as beep, advice, reminding or warning through speaker 41, audio path 42 and
`
`audio interface 43 to the ear canal for a concerned health condition, data storage on
`
`
`
`11
`
`

`

`
`
`the CPM or transmission through RF 44 for the future analysis or review purpose.”
`
`Id. ¶ 33. Figure 3 shows a “system diagram illustrating the present invention as an
`
`intelligent medical monitoring device and system.” Id. ¶ 27.
`
`
`
`Id., Fig. 3.
`
`Notably, although Luo discloses a CPM 11 with memory, a CPU, an
`
`algorithm, parameters, and data storage, it does not disclose that said CPM uses the
`
`sensor data to create a serial data output of physiological and motion information
`
`such that a plurality of physiological parameters and activity parameters can be
`
`extracted from the sensor information. See Pollonini Decl. ¶ 49. For instance,
`
`although Luo discloses an I/O interface in Fig. 3, which is a “standard
`
`communication interface such as Universal Serial Bus (USB) port between the
`
`system and the external computer or device,” Luo, ¶ 43, such an interface is merely
`
`used for the transmission of data from one device to another. The ’941 patent, on the
`12
`
`
`
`

`

`
`
`other hand, describes and claims processing signals into a serial data output from
`
`which physiological and physical activity parameters can be extracted. Pollonini
`
`Decl. ¶ 80.
`
`2.
`
`Craw is directed to a specific data formatting scheme to
`address interoperability between medical devices.
`
`Craw, entitled “Device Data Sheets and Data Dictionaries for a Dynamic
`
`Medical Object Information Base,” relates to “methods, apparatus and systems for
`
`the communication of information among a plurality of network elements, and
`
`specifically to a dynamic medical object information base for interoperability of
`
`devices and systems.” Ex. 1056 (“Craw”), ¶ 2. Unlike the ’941 patent, Craw has
`
`nothing to do with monitoring any type of health conditions. Pollonini Decl. ¶ 50.
`
`Instead, it is directed to a specific data transmission scheme to address
`
`interoperability between medical devices: “Needs exist
`
`for
`
`improved
`
`communications protocols for acquisition and communication of data between
`
`network elements. Needs also exist for methods for interoperability of devices and
`
`systems.” Craw ¶ 9; see also id. ¶ 51 (“The following description describes use of a
`
`system for interoperability of medical devices on a network and particularly
`
`measurements of non-invasive blood pressure”) (emphasis added).
`
`Furthermore, although Craw may
`
`teach processing of “Serialized
`
`Communication Protocol Messages by Communication Protocol Architectural
`
`Structures,” id. ¶ 200, it does not discuss any way in which the data is formatted into
`13
`
`
`
`

`

`
`
`said serialized data outputs for extraction or use by APIs. See Pollonini Decl. ¶ 50-
`
`51. Instead, Craw’s main goal is to disclose communication protocols to make
`
`devices interoperable, whereas the ’941 patent discloses novel methods of
`
`formatting and processing signals in order to create a serial data output with multiple
`
`individual metrics to allow for simple protocols to be used for extracting the data
`
`from the sensor. Id. ¶ 50-51.
`
`B. Neither Luo nor Craw discloses that respiration rate can be
`extracted from signals obtained by a PPG sensor.
`
`Craw does not disclose or even suggest the use of any sensor, much less a
`
`physiological sensor or PPG sensor, to produce signals that can be processed into a
`
`serial data output from which respiration rate can be extracted. See Pollonini Decl.
`
`¶ 74. Notably, Petitioner does not contend that Craw discloses using a sensor from
`
`which respiration rate can be extracted. See generally Petition at 19-26 (discussing
`
`Craw, but using Luo to map to the respiration rate limitation). Thus, unless Luo
`
`discloses this feature Grounds 1-5 must fail as a matter of law. See, e.g., Ferring
`
`B.V. v. Watson Labs., Inc.-Florida, 764 F.3d 1401, 1407 (Fed. Cir. 2014) (“In this
`
`case, the cited prior art references neither set forth the limitations required by the
`
`asserted claims, nor provided any reason or motivation to combine those teachings
`
`to derive the claimed formulations with specific dissolution profiles. Accordingly,
`
`the asserted claims have not been shown to be invalid under § 103.”); 37 C.F.R. §
`
`
`
`14
`
`

`

`
`
`42.104(b)(4) (“The petition must specify where each element of the claim is found
`
`in the prior art patents or printed publications relied upon.”).
`
`As discussed in more detail in section II supra, claim 1 requires “at least one
`
`photoplethysmography (PPG) sensor for sensing the physiological information.”
`
`’941 patent, 30:38-43. Claim 1 further requires “processing signals … from the at
`
`least one PPG sensor … into a serial data output … 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 … .” Id., 20:44-54. Claim 1 does not allow that any “physiological
`
`information,” including respiration rate, can be sensed by anything besides a PPG
`
`sensor. See Pollonini Decl. ¶ 75. The Board appears to agree that a PPG sensor is the
`
`only type of sensor from which physiological data can be sensed and processed:
`
`Thus, claim 1 provides that the physiological information
`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.
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`Institution Decision at 22 (emphasis added). Unless Luo discloses a PPG sensor
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`from which a respiration rate can be derived, the combination of Luo and Craw fails
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`to render claim 1 obvious.
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`But Luo does not disclose that a PPG sensor produces a signal which can be
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`processed into an output comprising respiration rate. See Pollonini Decl. ¶ 76. All
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`Luo discloses is a separate processing module that outputs physiological signals that
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`are combined with activity and environmental variables to extrapolate a respiration
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`rate. See id.; see also Luo, claim 37. The ’941 patent, on the other hand, requires that
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`signals from a PPG sensor are used to directly output signals from which a
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`respiration rate can be derived. Pollonini Decl. ¶¶ 76-78; ’941 patent, 30:35-54.
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`In fact, Luo only mentions “respiratory rate” in claims 37 and 51.1 Claim 37
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`reads “[t]he healthcare system as in claim 32, wherein the processing module is
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`configured to process the physiological, activity and environment variables to
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`determine a respiratory rate and the output signal is based on the respiratory rate.”
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`Luo, Claim 37.2 In terms of physiological sensors, independent claim 32 only
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`discloses “at least one physiological sensor provided to the shell for measuring and
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`outputting a physiological variable representing a physiological condition of the
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`subject.” Luo, Claim 32. Accordingly, nothing in Luo discloses that a PPG sensor
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`is the “physiological sensor” from which “respiratory rate” can be derived. Instead,
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`claim 32 discloses that any type of physiological sensor may measure the
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`1 Luo contains no other references to related words such as “respiration.”
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`2 Claim 51 is substantially identical to claim 37, but is written in as a system claim
`as opposed to a method claim.
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`physiological data, while claim 37 merely discloses that a “processing module [that]
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`is configured to process the physiological, activity and environment variables to
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`determine a respiratory rate.” Luo, claim 37 (emphasis added).
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`Not only does Luo fail to disclose a PPG sensor capable of outputting a
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`respiratory rate, it expressly contemplates a processing module that employs not only
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`physiological factors to determine a respiratory rate, but instead relies on other
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`factors such as environmental variables. Pollonini Decl. ¶ 76; Luo, claim 37. This is
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`different from the requirement in claim 1 of the ’941 patent that respiration rate be
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`capable of extraction from the physiological information. See ’941 patent, 30:44-54.
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`Moreover, Luo’s claim 34, which also depends from claim 32, expressly discloses
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`that the “physiological sensor comprises at least one of an oximetry sensor (Sp02),
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`temperature sensor, or glucose sensor.” Luo, claim 34. Therefore, if Luo wanted to
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`disclose a PPG sensor (or, similarly, an SP02 oximetry sensor) to sense the
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`physiological data from which the respiratory rate could be extracted, Luo certainly
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`knew how to do so. Pollonini Decl. ¶ 77. Instead, the only logical conclusion to draw
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`is that Luo purposefully chose not to describe his invention as including a PPG
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`sensor from which a respiratory rate can be extracted, because it does not. Id. ¶ 77.
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`Luo’s lack of any disclosure of a PPG or oximetry sensor providing signals
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`that are processed into a serial data output from which it is possible to derive a
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`respiration rate shows that a key limitation of claim 1 of the ’941 patent is not
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`disclosed by the combination of Luo and Craw. Id. ¶ 78. Based on this fact alone,
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`Grounds 1-5, based on Luo and Craw, fail.
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`C. Neither Luo nor Craw discloses elements [1.4] and [1.5], and a
`POSA would not have been motivated to combine Luo and Craw
`to render disclosures obvious.
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`Neither Luo nor Craw individually disclose processing signals from a motion
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`sensor and PPG sensor into a serial data output of physiological and motion-related
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`information. Thus, Petitioner fails to demonstrate that claim 1 or its dependent
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`claims are obvious. Additionally, even if it were determined that Luo and Craw
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`disclose features that, when combined, disclose or render this limitation obvious,
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`there is no reason that a POSA would combine Luo and Craw.
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`Petitioner’s analysis appears to ignore critical portions the claim limitations
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`that Petitioner labels as [1.4] and [1.5], which together read as follows:
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`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, 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 and
`such that a plurality of subject physical activity parameters
`can be extracted from the motion-related information.
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`’941 Patent, 30:45-54 (emphasis added to highlight terms Petitioner fails to properly
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`analyze). When these claim terms are properly viewed in the context of the rest of
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`the claim, it is clear that the serial dat