Paper No. 1
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`____________________
`
`
`APPLE INC.,
`Petitioner,
`
`v.
`
`OMNI MEDSCI, INC.,
`Patent Owner.
`
`Patent No. 9,651,533
`
`____________________
`
`Inter Partes Review No. IPR2019-00913
`__________________________________________________________________
`
`Petition for Inter Partes Review of
`U.S. Patent No. 9,651,533
`
`
`
`
`
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`Table of Contents
`
`Introduction .................................................................................................... 1
`I.
`II. Regulatory Information ................................................................................ 3
`A. Certification that Petitioner May Contest the ’533 Patent
`(§ 42.104(a)) .......................................................................................... 3
`Identification of Claims Being Challenged (§ 42.104(b)) ................ 4
`B.
`Fee for Inter Partes Review (§ 42.15(a)) ............................................ 5
`C.
`Service on Patent Owner (§ 42.105) ................................................... 5
`D.
`III. The ’533 Patent and Background Technology ............................................ 5
`A.
`Photoplethysmography ....................................................................... 5
`B.
`Industry Trends Drove Development of Mobile Network-
`Connected Devices to Track Health Traits Before 2012 ................. 8
`IV. The ’533 Patent ............................................................................................ 12
`A.
`The ’533 Patent Is Subject to AIA ................................................... 12
`B.
`File History ......................................................................................... 17
`C.
`Person of Ordinary Skill in the Art ................................................. 17
`V. Claim Construction ..................................................................................... 18
`“Beam” ............................................................................................... 20
`A.
`“Plurality of lenses” .......................................................................... 21
`B.
`“Pulse rate” ........................................................................................ 21
`C.
`VI. Detailed Explanation Why the ’533 Patent Claims Are Unpatentable .. 22
`A. Ground 1: Valencell-093 and Valencell-099 Render Obvious
`Claims 5, 7-10, 13, and 15-17 ............................................................ 23
`1.
`Overview of Valencell-093 ....................................................... 23
`2.
`Overview of Valencell-099 ....................................................... 26
`3.
`A Skilled Person Would Have Considered Valencell-093 With
`Valencell-099 ............................................................................ 27
`Independent Claim 13 ............................................................... 32
`
`4.
`
`
`
`ii
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`(2)
`
`(3)
`
`(4)
`
`(5)
`
`a)
`b)
`
`c)
`
`d)
`
`e)
`
`f)
`
`Preamble ......................................................................... 33
`“a wearable measurement device for measuring one or
`more physiological parameters” ..................................... 33
`(1)
`“including a light source comprising a plurality of
`semiconductor sources that are light emitting
`diodes” .................................................................. 34
`“the light emitting diodes configured to generate
`an output optical beam with one or more optical
`wavelengths” ........................................................ 35
`“wherein at least a portion of the one or more
`optical wavelengths is a near-infrared wavelength
`between 700 nanometers and 2500 nanometers” . 35
`“the light source configured to increase signal-to-
`noise ratio by increasing a light intensity from at
`least one of the plurality of semiconductor
`sources” ................................................................ 36
`“and by increasing a pulse rate of at least one of
`the plurality of semiconductor sources;” .............. 37
`“the wearable measurement device comprising a plurality
`of lenses configured to receive a portion of the output
`optical beam and to deliver an analysis output beam to a
`sample;” .......................................................................... 39
`“the wearable measurement device further comprising a
`receiver configured to receive and process at least a
`portion of the analysis output beam reflected or
`transmitted from the sample and to generate an output
`signal” ............................................................................. 41
`“wherein the wearable measurement device receiver is
`configured to be synchronized to pulses of the light
`source” ............................................................................ 42
`“a personal device comprising a wireless receiver, a
`wireless transmitter, a display, a microphone, a speaker,
`one or more buttons or knobs, a microprocessor and a
`touch screen,” ................................................................. 44
`(1)
`“the personal device configured to receive and
`process at least a portion of the output signal,” ... 46
`“wherein the personal device is configured to store
`and display the processed output signal” ............. 48
`
`(2)
`
`
`
`iii
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`5.
`
`(3)
`
`(2)
`
`(2)
`
`“and wherein at least a portion of the processed
`output signal is configured to be transmitted over a
`wireless transmission link;” ................................. 49
`“and a remote device configured to receive over the
`wireless transmission link an output status comprising the
`at least a portion of the processed output signal,” .......... 50
`(1)
`“[the remote device configured] to process the
`received output status to generate processed data
`and to store the processed data,” .......................... 52
`“and wherein the remote device is capable of
`storing a history of at least a portion of the
`received output status over a specified period of
`time.” .................................................................... 53
`Independent Claim 5 ................................................................. 55
`a)
`Preamble ......................................................................... 55
`b)
`“a light source comprising a plurality of … light emitting
`diodes …” ....................................................................... 55
`(1)
`“the light source configured to increase signal-to-
`noise ratio by increasing a light intensity from at
`least one of the plurality of semiconductor sources
`….” ....................................................................... 55
`“and by increasing a pulse rate of at least one of
`the plurality of semiconductor sources” ............... 55
`“an apparatus comprising a plurality of lenses configured
`to receive a portion of the output optical beam and to
`deliver an analysis output beam to a sample” ................ 55
`“a receiver configured to receive and process at least a
`portion of the analysis output beam reflected or
`transmitted from the sample and to generate an output
`signal,” ............................................................................ 56
`‘wherein the receiver is configured to be synchronized to
`pulses of the light source” .............................................. 56
`“a personal device comprising a wireless receiver, a
`wireless transmitter, a display, a microphone, a speaker,
`one or more buttons or knobs, a microprocessor and a
`touch screen” .................................................................. 56
`
`g)
`
`c)
`
`d)
`
`e)
`
`f)
`
`
`
`iv
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`(1)
`
`(3)
`
`g)
`
`6.
`
`“the personal device configured to receive and
`process at least a portion of the output signal” .... 57
`(2) wherein the personal device is configured to store
`and display the processed output signal” ............. 57
`“and wherein at least a portion of the processed
`output signal is configured to be transmitted over a
`wireless transmission link” ................................... 57
`“a remote device configured to receive over the wireless
`transmission link an output status comprising the at least
`a portion of the processed output signal,” ...................... 57
`(1)
`“to process the received output status to generate
`processed data and to store the processed data.” . 58
`Comparison of Dependent Claims to Valencell-093 and
`Valencell-099 ............................................................................ 58
`a)
`Dependent Claims 7 and 15 ............................................ 58
`b)
`Dependent Claims 8 and 16 ............................................ 60
`c)
`Dependent Claims 9 and 17 ............................................ 62
`d)
`Dependent Claim 10 ....................................................... 63
`B. Ground 2: Valencell-093 and Valencell-099 in view of Carlson
`Render Obvious Claims 5, 7-10, 13 and 15-17 ................................ 64
`1.
`Overview of Carlson ................................................................. 64
`2.
`A Skilled Person Would Have Modified The Sensor of
`Valencell-093 to Incorporate Elements Shown in Carlson....... 65
`Independent Claims 5 and 13 .................................................... 67
`3.
`Dependent Claims 7-10, and 15-17 .......................................... 69
`4.
`C. Ground 3: Valencell-093 and Valencell-099 in view of
`Mannheimer Render Obvious Claims 8-9 and 16-17 .................... 69
`D. No Secondary Considerations Exist ................................................ 75
`VII. Conclusion .................................................................................................... 75
`Claim Appendix ...................................................................................................... 77
`
`
`
`
`
`v
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`TABLE OF AUTHORITIES
`
`Page(s)
`
`Cases
`Droplets, Inc. v. E*trade Bank,
`887 F.3d 1309 (Fed. Cir. 2018) .......................................................................... 15
`Kennametal, Inc. v. Ingersoll Cutting Tool Co.,
`780 F.3d 1376 (Fed. Cir. 2015) .......................................................................... 46
`In re Petering,
`301 F.2d at 681 ................................................................................................... 46
`Sinorgchem Co., Shandong v. Int’l Trade Comm’n,
`511 F.3d 1132 (Fed. Cir. 2007) .......................................................................... 20
`Statutes
`35 U.S.C. § 102 ................................................................................17, 23, 26, 64, 69
`35 U.S.C. § 103 .................................................................................................... 4, 17
`35 U.S.C. § 111 ........................................................................................................ 16
`35 U.S.C. § 112 .................................................................................................. 14, 15
`35 U.S.C. § 122 ........................................................................................................ 16
`35 U.S.C. § 315 .......................................................................................................... 4
`Pub. L. 112-29, §3(n) ............................................................................................... 17
`
`
`
`
`
`vi
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`Exhibit List
`
`Exhibit# Reference Name
`1001
`U.S. Patent No. 9,651,533
`1002
`U.S. Patent No. 9,651,533 File History
`1003
`Declaration of Brian W. Anthony, PhD
`1004
`Proof of Service of Summons in Omni MedSci, Inc. v. Apple Inc., No. 2:18-cv-
`134 (E.D. Tex.)
`U.S. Patent Publication No. 2012/0197093 (“Valencell-093”)
`U.S. Patent Publication No. 2010/0217099 (“Valencell-099”)
`U.S. Patent No. 6,505,133 (“Hanna”)
`U.S. Patent No. 5,746,206 (“Mannheimer”)
`U.S. Patent Publication No. 2005/0049468 (“Carlson”)
`U.S. Patent No. 9,596,990 (“Park”)
`U.S. Patent No. 9,241,676 (“Lisogurski”)
`RESERVED
`RESERVED
`U.S. Patent No. 8,172,761 ("Rulkov")
`Provisional Application No. 61/747,487
`Provisional Application No. 61/747,472
`Provisional Application No. 61/747,477
`Provisional Application No. 61/754,698
`"The Biomedical Engineering Handbook," by Joseph D. Bronzino (1995)
`M. Krantz, et al., The mobile fitness coach: Towards individualized skill
`assessment using personalized mobile devices, Pervasive and Mobile Computing
`(June 2012)
`Patel, et al., A review of wearable sensors and systems with application
`rehabilitation, Journal of Neuroengineering & Rehabilitation 2012 9:21
`
`1005
`1006
`1007
`1008
`1009
`1010
`1011
`1012
`1013
`1014
`1015
`1016
`1017
`1018
`1019
`1020
`
`1021
`
`
`
`vii
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`1023
`
`1024
`
`1025
`
`1026
`
`1027
`
`1028
`
`1029
`
`Exhibit# Reference Name
`1022
`ScienceDirect Report on M. Krantz, et al., The mobile fitness coach: Towards
`individualized skill assessment using personalized mobile devices, Pervasive and
`Mobile Computing (2012), available at
`https://www.sciencedirect.com/science/article/pii/
`S1574119212000673?via%3Dihub
`"The Usage of Tablets in the HealthCare Industry," by Rauf Adil, available at
`https://www.healthcareitnews.com/blog/usage-tablets-healthcare-industry (Aug. 2,
`2012)
`A. More, Bluetooth Low Enegery: Wireless Connectivity for Medical Monitoring,
`Journal of Diabetes Science & Technology (Mar. 2010)
`"Absorption Coefficient and Penetration Depth," The Science of Solar, available
`at https://photon.libretexts.org
`/The_Science_of_Solar/Solar_Basics/C._Semiconductors_and_Solar_Interactions/
`III._Absorption_of_Light_and_Generation/
`1._Absorption_Coefficient_and_Penetration_Depth
`F. Buttusi, et al., MOPET: A context-aware and user-adaptive wearable system for
`fitness training, Artificial Intelligence in Medicine (2008)
`P. Baum, et al., Strategic Intelligence Monitor on Personal Health Systems, Phase
`2: Market Developments - Remote Patient Monitoring and Treatment, Telecare,
`Fitness/Wellnes and mHealth, JRC Scientific and Policy Reports of European
`Commission (2013)
`"Compendium of Chemical Terminology Gold Book," International Union of
`Pure and Applied Chemistry, Version 2.3.3 (2014)
`M. Swan, Senior Mania! The Internet of Things, Wearable Computing, Objective
`Metrics, and the Quantified Self 2.0, Journal of Sensor and Actuator Networks
`(2012)
`Merriam-Webster's Collegiate Dictionary Eleventh Edition (2011)
`U.S. Patent Publication No. 2012/0041767 (“Hoffman”)
`U.S. Patent No. 7,278,966 (“Hjelt”)
`Lister et al., Optical properties of human skin (Journal of Biomedical Optics
`2012)
`Bashkatov et al., Optical properties of human skin, subcutaneous and mucous
`tissues in the wavelength range from 400 to 2000 nm, Journal of Physics D:
`Applied Physics (2005)
`E.F. Schubert, Light-Emitting Diodes (Cambridge Univ. Press, 2nd ed. reprinted
`2014)
`
`1030
`1031
`1032
`1033
`
`1034
`
`1035
`
`
`
`viii
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`1037
`1038
`1039
`
`1040
`
`1041
`
`1042
`
`1043
`
`1044
`
`1045
`1046
`
`1047
`
`Exhibit# Reference Name
`1036
`Barolet, Daniel, Light-Emitting Diodes (LEDs) in Dermatology (Seminars in
`Cutaneous Medicine and Surgery 2008)
`RESERVED
`RESERVED
`Omni MedSci Inc.’s Opening Claim Construction Brief, No. 2:18-cv-134-RWS
`(filed December 20, 2018)
`Apple Inc.’s Preliminary Claim Constructions and Extrinsic Evidence Pursuant to
`Patent Local Rule 4-2, No. 2:18-cv-134-RWS (filed November 1, 2018)
`Exhibit E from , Excerpts from the American Heritage Dictionary, 5th Edition,
`filed January 14, 2019, No. 2:18-cv-134-RWS
`Exhibit O, Excerpts from the American Heritage Dictionary, 5th Edition. Filed
`January 14, 2019. No. 2:18-cv-134-RWS
`Amended Joint Claim Construction and Prehearing Statement. Filed January 11,
`2019. No. 2:18-cv-134-RWS
`Claim Construction Markman Hearing Transcript, February 6, 2019. No. 2:18-cv-
`134-RWS
`District Court Preliminary Claim Constructions. Case No. 2:18-cv-134-RWS
`Exhibit G, Excerpts from Merriam-Webster’s Collegiate Dictionary, Eleventh
`Edition, No. 2:18-cv-134-RWS
`Exhibit N, Excerpts from Merriam-Webster’s Collegiate Dictionary, Eleventh
`Edition, No. 2:18-cv-134-RWS
`U.S. Patent No. 6,044,283 (“Fein”)
`U.S. Patent No. 5,774,213 (“Trebino”)
`U.S. Patent No. 5,855,550 (“Lai”)
`U.S. Patent No. 6,898,451 (“Wuori”)
`U.S. Patent No. 4,972,331 (“Chance”)
`Curriculum Vitae of Brian W. Anthony, PhD
`Dr. Mohammed Islam, Faculty Profile, University of Michigan, College of
`Engineering (available at https://islam.engin.umich.edu)
`Technology Transfer Policy, University of Michigan (available at
`https://techtransfer.umich.edu/for-inventors/policies/technology-transfer-policy/)
`
`1048
`1049
`1050
`1051
`1052
`1053
`1054
`
`1055
`
`
`
`ix
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`Exhibit# Reference Name
`1056
`Bylaws of the University of Michigan Board of Regents, (available at
`http://www.regents.umich.edu/bylaws/bylawsrevised_09-18.pdf)
`
`
`
`
`
`
`
`
`x
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`
`
`Petitioner’s Mandatory Notices
`
`A. Real Party in Interest (§42.8(b)(1))
`
`The real party in interest of this petition pursuant to § 42.8(b)(1) is Apple
`
`Inc. (“Apple”) located at One Infinite Loop, Cupertino, CA 95014.
`
`B. Other Proceedings (§42.8(b)(2))
`
`1.
`
`Patents and Applications
`
`U.S. Patent No. 9,651,533 (“’533 Patent”) is related to following issued
`
`patents or pending applications:
`
`•
`
`•
`
`•
`
`U.S. Patent No. 9,164,032
`
`U.S. Appl. No. 15/594,053
`
`U.S. Appl. No. 16/015,737
`
`2.
`
`Related Litigation
`
`The ’533 Patent has been asserted in the following litigations:
`
`• Omni MedSci, Inc. v. Apple Inc., Action No. 2-18-cv-00134-RWS
`
`(pending).
`
`3.
`
`Patent Office Proceedings
`
`The ’533 Patent is the subject of IPR2019-00916 filed by Apple.
`
`
`
`xi
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`C.
`
`Lead and Backup Lead Counsel (§42.8(b)(3))
`
`Lead Counsel is: Jeffrey P. Kushan (Reg. No. 43,401), jkushan@sidley.com,
`
`(202) 736-8914. Back-Up Lead Counsel are: Ching-Lee Fukuda (Reg. No.
`
`44,334), clfukuda@sidley.com, (212) 839-7364; Kathi Cover (Reg. No. 37,803),
`
`kcover@sidley.com, (202) 736-8377; and Thomas A. Broughan III (Reg. No.
`
`66,001), tbroughan@sidley.com, (202) 736-8314.
`
`D.
`
`Service Information (§42.8(b)(4))
`
`Service on Petitioner may be made by e-mail (iprnotices@sidley.com), mail
`
`or hand delivery to: Sidley Austin LLP, 1501 K Street, N.W., Washington, D.C.
`
`20005. The fax number for lead and backup lead counsel is (202) 736-8711.
`
`
`
`
`
`xii
`
`

`

`IPR2019-00913
`
`
`
`Petition for Inter Partes Review
`
`I.
`
`Introduction
`Health monitoring systems based on optical sensors, which measure
`
`physiological parameters of a user based on how light interacts with the user’s
`
`tissue and blood, have been ubiquitous for decades. Once found only in hospitals
`
`and doctor’s offices, these monitors are now mainstream consumer devices. Over
`
`time, these devices evolved to become smaller, digital, wireless, and Internet-
`
`connected, an evolution driven by several market trends and forces. One sought to
`
`meet the needs and convenience of users for such devices to be wearable,
`
`unobtrusive and mobile. Another addressed the need to integrate these devices into
`
`a digital data processing environment based on real-time collection and delivery of
`
`user data. A third responded to consumer demand for personal health and fitness
`
`monitoring devices.
`
`By 2012, the prior art described numerous wearable optical sensing devices
`
`with common attributes. They used LEDs emitting light at multiple wavelengths;
`
`were small, battery powered and wearable on the wrist or ear; and could wirelessly
`
`communicate with other devices. This prior art also described solutions to the
`
`various challenges of developing such devices, including mitigating noise caused
`
`by user movement and ambient light, minimizing power consumption, and
`
`arranging the electronic and optical components within the smallest possible space.
`
`1
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`Relative to this extensive body of prior art, the contested claims of the ’533
`
`Patent do not recite anything inventive. Rather, they cobble together well-known
`
`techniques for improving the signal-to-noise ratio of a sensor with routine and
`
`predictable combinations of known optical components, techniques a well-known
`
`textbook describes as the “basic building blocks” of such optical sensors. See
`
`Ex.1019 (“BE Handbook”), 765.
`
`For example, U.S. Patent Publication No. 2012/0197093 (“Valencell-093”)
`
`(Ex.1005) and U.S. Patent Publication No. 2010/0217099 (“Valencell-099”)
`
`(Ex.1006) describe complimentary aspects of a Bluetooth headset that incorporates
`
`an optical sensor into an earbud. Valencell-099 provides detailed descriptions of
`
`the optical components used by an LED-based sensor to measure heart rate and
`
`various blood constituents, as well as signal processing techniques for extracting
`
`accurate physiological information from a detected signal in a noisy environment.
`
`Valencell-099 describes applications of such devices, including wireless
`
`communication of user health data between the sensor and a personal device such
`
`as a smart phone, which in turn communicates with a database, computer or other
`
`remote device. The combination of the headset of Valencell-093 interacting with
`
`the personal device and remote terminal of Valencell-099 renders all contested
`
`claim obvious.
`
`2
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`Other prior art, such as U.S. Patent Publication No. 2005/0049468
`
`(“Carlson”) (Ex.1009) and U.S. Patent No. 5,746,206 (“Mannheimer”) (Ex.1008),
`
`describe conventional techniques used in such optical monitors that correspond to
`
`those recited in the contested claims. For example, Carlson describes increasing a
`
`pulse rate of the emitters in order to improve a signal to noise ratio. Should Patent
`
`Owner argues that Valencell-093 does not disclose this conventional technique, it
`
`would have been obvious to modify the Valencell sensor as described by Carlson.
`
`Mannheimer teaches how to spatially arrange multiple emitters and detectors in a
`
`sensor, and then process the detected signals to remove noise interference from
`
`skin. Should Patent Owner argue that the Valencell-093 sensor does not have
`
`appropriately spaced sensors as described by claims 8-9 and 16-17, it would have
`
`been obvious to modify the Valencell-093 sensor as described by Mannheimer.
`
`Nothing in the contested claims is inventive over this prior art. Petitioner
`
`therefore respectfully requests that trial be instituted and the contested claims
`
`cancelled.
`
`II. Regulatory Information
`A. Certification that Petitioner May Contest the ’533 Patent
`(§ 42.104(a))
`Petitioner certifies that the ’533 Patent is available for inter partes review.
`
`Petitioner also certifies it is not barred or estopped from requesting inter partes
`
`review of the claims of the ’533 Patent. Neither Petitioner, nor any party in privity
`
`3
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`with Petitioner, has filed a civil action challenging the validity of any claim of the
`
`’533 Patent. The ’533 Patent has not been the subject of a prior inter partes review
`
`by Petitioner or a privy of Petitioner.
`
`Petitioner also certifies this petition for inter partes review is timely filed as
`
`this petition was filed within one year after April 10, 2018, the date Petitioner was
`
`first served with a complaint alleging infringement of a claim of the ’533 Patent.
`
`See 35 U.S.C. § 315(b); Ex. 1004.
`
`B.
`Identification of Claims Being Challenged (§ 42.104(b))
`Claims 5, 7-10, 13, and 15-17 are unpatentable based on the following
`
`grounds.
`
`(i) Ground 1: Claims 5, 7-10, 13, and 15-17 are rendered obvious under
`
`35 U.S.C. § 103 based on U.S. Patent Publication No. 2012/0197093 (“Valencell-
`
`093”) (Ex. 1005) and U.S. Patent Publication No. 2010/0217099 (“Valencell-
`
`099”) (Ex.1006).
`
`(ii) Ground 2: Claims 5, 7-10, 13, and 15-17 are rendered obvious under
`
`§ 103 based on Valencell-093 and Valencell-099 in view of U.S. Patent
`
`Publication No. 2005/0049468 (“Carlson”) (Ex.1009).
`
`(iii) Ground 3: Claims 8-9 and 16-17 are rendered obvious under § 103
`
`based on Valencell-093 and Valencell-099 in view of U.S. 5,746,206
`
`(“Mannheimer”) (Ex.1008) with or without Carlson.
`
`4
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`C.
`Fee for Inter Partes Review (§ 42.15(a))
`The Director is authorized to charge the fee specified by 37 C.F.R.
`
`§ 42.15(a) to Deposit Account No. 50-1597.
`
`D.
`Service on Patent Owner (§ 42.105)
`Omni MedSci, Inc. is identified as the patent owner of record in the
`
`assignment records for the ’533 Patent. The named inventor of the ’533 Patent, Dr.
`
`Islam, has been a member of the faculty of the University of Michigan since
`
`1992. Ex.1054. Based on the University of Michigan Bylaw 3.10 and Technology
`
`Transfer Policy, the University of Michigan is the owner of the ’040
`
`Patent. Ex.1055, Ex.1056 at 21-22. Dr. Islam has also purported to assign the
`
`patent to OmniMedSci. Id. Petitioner has thus served this petition on both the
`
`University of Michigan and Omni MedSci.
`
`III. The ’533 Patent and Background Technology
`A.
`Photoplethysmography
`Optical health monitors use a sensing technique called
`
`photoplethysmography (“PPG”) that has been known and used for decades in
`
`medical monitoring systems. Ex.1003, ¶37; Ex.1019, 769-76, 1346-55 (discussing
`
`oximetry and other applications). PPG works by shining light through a person’s
`
`tissue and measuring the light that is either reflected back or transmitted through
`
`the tissue. Ex.1019, 766. Different components of blood and tissue absorb and
`
`reflect different wavelengths of light. Ex.1003, ¶38. By measuring how much
`5
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`light is absorbed and how the absorption changes over time, a device can calculate
`
`the components of the blood and tissue. Ex.1003, ¶38.
`
`For example, hemoglobin (the substance in blood that carries oxygen to
`
`cells) reflects more red light when it is oxygenated and absorbs more red light
`
`when it is deoxygenated. Ex.1019, 769; see Ex.1003, ¶39. Hemoglobin, however,
`
`reflects the same amount of infrared (IR) light whether oxygenated or
`
`deoxygenated. Ex.1019, 769. If a device measures the absorbed red and IR light
`
`multiple times per second, the device can determine several things: (i) the ratio of
`
`oxygenated to deoxygenated hemoglobin (oxygen saturation), and (ii) how the
`
`volume of blood in the tissue changes over time, allowing it to detect a person’s
`
`pulse. Ex.1019, 769, 771; Ex.1003, ¶39.
`
`PPG is an optical technique, and as such, it uses conventional optical
`
`components. Ex.1003, ¶40. The 1995 BE Handbook explains that the “basic
`
`building blocks” of optical sensor systems include lenses, mirrors, filters, beam
`
`splitters, light sources, fiber optics, and detectors (Ex.1019, 765), and illustrates
`
`their use in an exemplary device below:
`
`6
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`
`
`Ex.1019, 765.
`
`Portable devices conventionally use light emitting diodes (LEDs) as the light
`
`source because LEDs are small and have low power requirements. Ex.1019, 765;
`
`Ex.1003, ¶40. As shown in the figure above, the light from the LED is directed
`
`through a lens and onto a sample. Ex.1019, 765. The light reflects back from the
`
`sample, is filtered, and sensed by a photodetector. Ex.1019, 765; Ex.1003, ¶¶41-
`
`43. The photodetector outputs a signal proportionate to the measured light
`
`intensity, and then analog-to-digital conversion and signal processing are
`
`performed to extract data. Ex.1019, 766. To improve the signal-to-noise ratio, the
`
`light source is typically modulated, and the detector uses “synchronized lock-in
`
`amplifier detection” to isolate signals that occur at the modulation frequency.
`
`7
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`Ex.1019, 764, 766. This allows the detector to reduce the noise in the detected
`
`signal. Ex.1003, ¶¶44-45.
`
`B.
`
`Industry Trends Drove Development of Mobile Network-
`Connected Devices to Track Health Traits Before 2012
`From 2000 to 2012, several market trends and needs were driving the
`
`medical device industry to develop wearable, mobile sensor devices that could
`
`wirelessly communicate user data to remote devices. Ex.1003, ¶48.
`
`One pronounced market need during this period was the challenge of
`
`providing medical care for patients in their homes or other locations where there
`
`was not easy access to a physician. This drove development of wireless
`
`monitoring technologies that could be worn by the patient and used to transmit data
`
`to a remote physician or care provider. Ex.1021, 2; Ex.1024, 462; Ex.1027, 15-31;
`
`see Ex.1003, ¶¶48, 52-53.
`
`Another trend during this period was to bring heart rate sensing devices
`
`based on pulsoximetry to the consumer market for personal fitness tracking and
`
`other uses. Ex.1003, ¶¶49-50. This trend was reflected in numerous references
`
`published before and around 2012. For example, a June 2012 review observed:
`
`A multitude of commercial health devices and sensors, such as
`oximeters and heart rate monitors, formerly reserved for professional
`use, are now available and can be connected to smartphones. GPS
`watches, pedometers and heart rate monitors, allow recording and
`tracking of physical activity.
`
`8
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`Ex.1020, 3; see also, e.g., Ex.1009, [0004] (“Pulsoximetry measuring devices are
`
`also used in sports for control and survey of athletes.”); Ex.1029, 221 (“Wristband
`
`sensors are a predecessor to smartwatches and remain a successful product
`
`category on their own…”); Ex.1005, [0003] (“There is growing market demand for
`
`personal health… monitors, for example, for gauging overall health, fitness,
`
`metabolism, and vital status during exercise, athletic training…”); Ex.1027, 33, 35.
`
`A third trend was to take advantage of the miniaturization of electronics and
`
`communication technology, which led to the development of smaller, wearable
`
`monitoring systems for mobile health and fitness applications. Ex.1021, 3;
`
`Ex.1020, 2 see Ex.1003, ¶¶51-52.
`
`A fourth trend in the medical industry was to use apps and smartphones to
`
`not only deliver care to patients but to give individuals access to health data for
`
`fitness or health issues. This drove integration of miniaturized, network-connected
`
`monitoring devices with smartphones and similar devices. Ex.1027, 9-10, 40-49;
`
`Ex.1023, 1-2 (“Doctors and nurses were the early adopters of tablets”); Ex.1021, 4;
`
`see Ex.1023, 5 (One of “the biggest usage of tablets stems from… [p]atient
`
`monitoring and data collection…, includ[ing] using the Bluetooth enabled sensor
`
`devices and Wi-Fi+ Bluetooth enabled interfaces to patient monitoring devices, to
`
`medical instruments that can transmit information to the tablet when in the
`
`9
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`vicinity.”); Ex.1027, 41 see Ex.1003, ¶¶51-52. It also led to the prevalent use of
`
`cloud-based data transfer and storage of data. Ex.1003, ¶52.
`
`Before 2012, the combined effect of these market trends was to provide a
`
`strong motivation to integrate medical optical sensing techniques into miniaturized
`
`wearable consumer devices that communicate wirelessly with smart devices and
`
`remote services. Ex.1003, ¶¶49-50. These trends led to a proliferation of products
`
`before 2012 that shared this distributed architecture supporting personal health,
`
`sports, and mobile monitoring systems. Ex.1003, ¶53.
`
`One illustration of that architecture was reported in Patel 2012 (Ex.1021):
`
`Ex.1021, 2. As this figure illustrates, data from wearable sensors is transmitted to
`
`a cell phone, which in turn transmits the data, along with GPS information, to
`
`
`
`10
`
`

`

`Petition in IPR2019-00913
`
`
`
`U.S. Patent No. 9,651,533
`
`remote devi