Case 1:19-cv-11586-FDS Document 324-4 Filed 02/23/22 Page 1 of 20
`Case 1:19-cv-11586-FDS Document 324-4 Filed 02/23/22 Page 1 of 20
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`EXHIBIT 4
`EXHIBIT 4
`
`
`

`

`Case 1:19-cv-11586-FDS Document 324-4 Filed 02/23/22 Page 2 of 20
`eet——~— "NTTAAATET
`
`US008277377B2
`
`US 8,277,377 B2
`(10) Patent No.:
`a2) United States Patent
`Quy
`(45) Date of Patent:
`Oct. 2, 2012
`
`
`(54) METHOD AND APPARATUS FOR
`MONITORING EXERCISE WITH WIRELESS
`INTERNET CONNECTIVITY
`
`(56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
`
`(75)
`
`Inventor: Roger J. Quy, Mill Valley, CA (US)
`.
`.,
`(73) Assignee: Q-Tec Systems LLC, Wilmington, DE
`(US)
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C, 154(b)by 32 days.
`(21) Appl. No.: 12/211,033
`
`(*) Notice:
`
`JP
`
`(22)
`
`Filed:
`
`Sep. 15, 2008
`
`Es
`
`4,282,883 A
`5,012,814 A
`5,307,263 A
`5,357,427 A
`5,410,471 A *
`5,434,611 A
`5,441,047 A
`5,474,090 A
`
`8/1981 Yerushalmy
`5/1991 Millset al.
`4/1994 Brown
`10/1994 Langenetal.
`4/1995 Alyfukuetal. wc. 600/300
`7/1995 Tamura
`8/1995 David etal.
`12/1995 Begun BE AL. eseernre 600/520
`(Continued)
`FOREIGN PATENT DOCUMENTS
`9224917
`9/1997
`(Continued)
`OTHER PUBLICATIONS
`
`(65)
`
`Prior Publication Data
`US 2009/0069643 Al
`Mar. 12, 2009
`
`U.S. Appl. No. 60/264,739,filed Jan. 2011, Posaetal.
`(Continued)
`Primary Examiner — Sam Yao
`Assistant Examiner — Shirley Jian
`Related U.S. Application Data
`ee Mnomey,Agent or Firm — Mark D. Wieczorek;
`(63) Continuation of application No. 11/649,703, filed on
`y
`~
`Jan. 3, 2007, now abandoned,whichis a continuation
`(57)
`ABSTRACT
`of application No. 11/184,274,filed on Jul. 18, 2005,
`A method and apparatus are provided for wireless monitoring
`now Pat. No. 7,156,808, which is a continuation of
`of exercise, fitness, or nutrition by connecting a web-enabled
`application No. 10/418,845, filed on Apr. 18, 2003,
`wireless phone to a device which provides exercise-related
`now Pat. No. 6,936,007, which is a continuation of
`application No. 09/738,270, filed on Dec. 15, 2000,—_information,including physiological data and data indicating
`now Pat. No. 6,602,191.
`an amountofexercise performed. The connection may be by
`way of a wireless connection using
`protocols such as Blue-
`(60) Provisional application No. 60/172,486,filed on Dec.
`hoth® or 802.11, or by way oftwined connection. An
`17, 1999.
`optional adaptor may be included ifnecessary. An application
`for receiving the exercise-related information and providing a
`user interface may be downloaded to the web-enabled wire-
`less phone from an internet server. The exercise-related infor-
`mation maybe transmitted to an internetserver, and the server
`maycalculate andreturn a response.
`19 Claims, 8 Drawing Sheets
`
`(51)
`
`Int. Cl.
`(2006.01)
`A61B 5/00
`(52) US.Ch ou... 600/300; 600/301; 128/903; 128/920
`(58) Field of Classification Search «0.0.0.0... None
`See application file for complete search history.
`
`
`
`

`

`Case 1:19-cv-11586-FDS Document 324-4 Filed 02/23/22 Page 3 of 20
`Case 1:19-cv-11586-FDS Document 324-4 Filed 02/23/22 Page 3 of 20
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`US 8,277,377 B2
`
`Page 2
`
`U.S. PATENT DOCUMENTS
`
`FOREIGN PATENT DOCUMENTS
`
`11047101
`11122369
`11259783
`2002/344660 A
`WO 95/32480
`WO 97/28736
`WO97/28737
`WO 98/24358
`WO 98/38909
`WO 99/04687
`WO 99/14882
`WO 99/41682
`WO 99/44494
`WO 99/46718
`WO 00/36900
`WO 00/40145
`WO 00/54205
`WO 00/54206
`WO 00/62662
`WO 01/24038
`
`2/1999
`4/1999
`9/1999
`11/2002
`11/1995
`8/1997
`8/1997
`6/1998
`9/1998
`2/1999
`3/1999
`8/1999
`9/1999
`9/1999
`6/2000
`7/2000
`9/2000
`9/2000
`10/2000
`4/2001
`
`OTHER PUBLICATIONS
`
`8/1996 David etal.
`5,544,649 A
`8/1996 Daviset al.
`5,544,661 A
`8/1996 Tacklind etal.
`5,549,117 A
`9/1996 Chenet al.
`5,553,609 A
`11/1996 Stutman etal.
`5,576,952 A
`2/1997 Quy
`5,601,435 A
`5/1997 Tacklind etal.
`5,626,144 A
`10/1997 Sellers
`5,678,562 A
`12/1997 Simmonsetal.
`5,701,904 A
`1/1998 Tacklind etal.
`5,704,366 A
`3/1998 Tavori
`5,724,025 A
`3/1998 Tacklindet al.
`5,732,709 A
`4/1998 Albert etal.
`5,735,285 A
`5/1998 Fuchs
`5,752,917 A
`6/1998 Heinonen etal.
`5,772,586 A
`8/1998 Woodard
`5,791,342 A
`8/1999 Saltzstein et al.
`5,931,791 A
`8/1999 Brown
`5,933,136 A
`8/1999 Tliff
`5,935,060 A
`8/1999 Saltzstein et al.
`5,941,829 A
`9/1999 Brown
`5,951,300 A
`9/1999 Laysonetal.
`5,959,533 A
`10/1999 Asada et al.
`5,964,701 A
`USS. Appl. No. 60/264,739,filed Jan. 2001, Posa etal.
`10/1999 Ridgeway
`5,967,975 A
`Jyrki Oraskari ; “Bluetooth versus WLAN IEEE 802.1 1X”; Helsinki
`11/1999 Klein et al.
`5,987,352 A
`University of Technology (Department of Computer Science and
`11/1999 Peifer etal.
`5,987,519 A
`Engineering) Nov. 2000.
`5,997,476 A * 12/1999 Brown vce 600/300
`Jack Smith ; Your Personal Health Buddy; ABCNews.com; http:/
`6,013,007 A *
`1/2000 Rootet al. occ 482/8
`abcnews.go.com/sections/tech/CuttingEdge/cuttingedge990225.
`6,022,315 A
`2/2000 Iliff .
`html; 3 pages (Nov. 24, 2000).
`6,024,699 A
`2/2000 Surwitet al.
`The Health Hero Communications Platform ; The Health Hero Net-
`6,050,940 A
`4/2000 Braunet al.
`.
`:
`:
`6,055,506 A
`4/2000 Frasca, Jr.
`work Online Services ; http:/www.hhn.com/products/Index.html ; 2
`6,057,758 A
`5/2000 Dempseyet al.
`
`6,059,692 A * 5/2000 Hickman vaccccscsssseeeere 482/g__Pages (Nov. 24, 2000).
`6,083,156 A
`7/2000 Leseicki
`“Cell Phones Cameras Put Doctorsin the Picture”, Feb. 21, 2005, 1
`6,093,146 A
`7/2000 Filangeri
`page,
`http://news.healingwell.com/index.php?p=
`6,101,478 A
`8/2000 Brown
`mews1&id=524118.
`6,139,494 A * 10/2000 Caimes oe 600/300
`Painless Blood-Glucose Monitoring ; Kumertrix Technology Over-
`6,144,837 A
`11/2000 Quy
`view; http:/www.kumertrix.com/technology.html; 2 pages; Nov. 24,
`6,160,478 A
`12/2000 Jacobsenet al.
`2000.
`6,168,563 Bl
`1/2001 Brown
`Technology & Clinical Results-Simple Solutions Through Technol-
`6,190,324 Bl
`2/2001 Kievaletal.
`ogy-Progression of Glucose Monitoring Technology ; Amira; http:/
`6,266,645 Bl
`7/2001 Simpson
`amira.com/tech/tc__tech.htm; 2 pages; Nov. 24, 2000.
`6,309,342 B1* 10/2001 Blazeyetal. oo... 600/26
`Wired for Wellness ; LifeChart.com ; http:/www.lifechart.com ; 2
`6,319,199 Bl
`11/2001 Sheehan etal.
`pages ; Nov. 24, 2000.
`6,336,900 Bl
`1/2002 Allecksonet al.
`About Data Critical Corporation ; Yahoo—Data Critical to Provide
`6,353,839 B1*
`3/2002 King etal... 715/236
`Mallincrodt with Wireless Connectivity for Ventilators ; http:/biz.
`6,375,614 Bl
`4/2002 Braun etal.
`yahoo.com/prnews/001012/mo_mallinc.html;
`1 page; Nov. 24,
`6,386,882 Bl
`5/2002 Linberg
`3000.
`6,416,471 Bl
`7/2002 Kumar et al.
`Bluetooth wireless technology-bridging the gap between computing
`6,418,346 B1
`7/2002 Nelsonetal.
`and communication; Bluetooth Technology;http://wwwintell.com-
`6,440,068 Bl
`8/2002 Brownet al.
`mobile/bluetooth/; 2 pages; Nov. 28, 2000.
`en Bi
`lone Brown ‘ at
`Bluetooth resource center ; What is Bluetooth ?; palowireless.com;
`6.478.736 Bl
`11/2002 Manit etal.
`Dibwww.palowireless.com/infotooth/watis.asp; 3 pages; Nov. 28,
`.
`.
`:
`2/2003 Rautila oe 463/40
`6,524,189 B1*
`Bluetooth Tutorial ; palowireless.com—bluetooth resource center ;
`:
`6,529,771 BI
`3/2003 Kieval et al.
`http://www. palowireless.com/infortooth/tutorial.asp; 4
`pages; Nov.
`
`
`
`
`6,602,191 B2 ASPs&Pages;8/2003. Quy 38. 2000 P NOV.
`6,610,012 B2
`8/2003 Mault
`,
`:
`.
`6.736.759 B1*
`5/2004 Stubbsetal.
`Bluetooth Profiles; palowireless.com—bluetooth resource center;
`
`9/2004 Mault et al. cccccccceeee 600/300
`6,790,178 BL*
`http://www.palowireless.com/infortooth/tutorial/profiles/asp;
`4
`2/2005 Matsumura etal.
`6,856,832 Bl
`pages; Nov. 28, 2000.
`6,936,007 B2
`8/2005 Quy
`Nick Hunt ; Bluetooth Venus 802.11 ; TDK Systems ; http://www.
`6,976,958 B2
`12/2005 Quy
`cellular.com.za/bluetooth_versus_802.htm; 4 pages; Nov.28, 2000.
`2001/0005830 AL*
`6/2001 Kuroyanagi
`Bluetooth vs. Airport
`(802.11 Network); palowireless.com—
`2002/0016719 Al
`2/2002 Nemeth et al.
`Bluetooth resource center; http://www.palowireless.com/infotooth/
`2002/0019584 Al
`2/2002 Schultze et al.
`knowbase/othernetworks/15.asp; 3 pages; Nov. 28, 2000.
`2002/0026223 Al
`2/2002 Riff et al.
`Personal Digital Assistants; A2 Anytime/Anywhere—A Weekly on
`2002/0072785 Al
`6/2002 Nelsonet al.
`Wireless Infrastructure and Data Services; Thomas Weisel Partners
`2002/0082480 Al
`6/2002 Riffeet al.
`(Merchant Banking), 5 pages; Nov. 29, 2000.
`2002/0120310 Al
`8/2002 Lindenet al.
`Ashlee Vance; Ericsson and Intel Make Bluetooth Pact; InfoWorld.
`2003/0004554 Al
`1/2003 Riff et al.
`com;
`http://www.infoworld.com/articles/hn/xml/00/12/04/
`2003/0072424 Al
`4/2003 Evansetal.
`001204hnericintel.xml?T.../printarticle.htm; 1 page; Dec. 4, 2000.
`2003/0139785 Al
`7/2003 Riff et al.
`Personal Portable Office; Nokia 9000il digital; http:/Awww.nokiausa.
`2003/0204413 Al
`10/2003 Riff
`com/9000il; 4 pages; Dec. 7, 2000.
`
`JP
`JP
`JP
`JP
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`WO
`
`
`
`......cccceeccen 7105/2
`
`

`

`Case 1:19-cv-11586-FDS Document 324-4 Filed 02/23/22 Page 4 of 20
`Case 1:19-cv-11586-FDS Document 324-4 Filed 02/23/22 Page 4 of 20
`
`US 8,277,377 B2
`Page 3
`
`“The MedStar System, How the MedStar System Works” brochure
`Pui-Wing Tam; Handspring Homes; Article from the Wall Street
`Journal; Section B; Nov. 2000.
`published by Cybernet Medical.
`Author unknown;Articles on Phones and New Technologies; Article
`“iMetrikus Mobile Solutions” brochure by iMetrikus,Inc.
`from the Wail Street Journal; Nov. 2000.
`“Instromedix—Products” published at www.instromedix.com/
`David Pringle; Sagen to Launch Hand-held Computer that Doubles
`pages/products.asp. 7 Pages.
`as Top-End Mobile Phone; Article from the Wall Street Journal; Nov.
`Joseph Finkelstein, el al., “Web-Based Monitoring ofAsthma Sever-
`2000.
`ity: A New Approach to Ambulatory Management”. Proc. 1998 IEEE
`Svensson, Peter; “Cisco Launches WiFi Phone”Article from Austra-
`Int’l Conf. on Info Tech. Applications in Biomedicine, 1998, pp.
`139-143.
`lian IT; Apr. 29, 2003.
`“Breakthrough Devices Shown At ADA”published in Diabetes News
`Yan Xiao, PhD. et al., “Design and Evaluation of a Real-Time Mobile
`for Jul. 1, 2001 at http://www.diabetesnet.com/news/news070 101.
`Telemedicine System for Ambulance Transport”, Proceedings ofthe
`php.
`1998 American Medical Informatics Association Annual Fall Sym-
`“iMetrikus” published at—http://www.qualcomm.com/qwbs/re-
`posium, 1998, pp. 1102-1103.
`source/resourcelib__casestdy.shtml.
`Yan Xiao, PhD. et al., “Design and Evaluation of a Real-Time Mobile
`“Applications of MedStar” published on Apr. 27, 2003 by Cybernet
`Telemedicine System for Ambulance Transport”, The Journal of
`Medical, 16 pages.
`High Speed Networks, 2000, vol. 9 (1), pp. 47-56.
`“HIPAA & WiFi: Regulatory Tangles for Wireless Health Care Net-
`EFI Framework Draft Version 0.8 (Jun. 3, 2000); External Function-
`works Analyzed” published at http://www.hipaadvisory.com/tech/
`ality Interface Framework;pp. 1-35.
`wireless htm.
`Internet Press Release: New York Business Wire (Sep. 25, 2000);
`“Medtronic CareLink Network, How it Works” published. at http://
`MedSearch Technologies, Inc. Develops a Revolutionary Home-
`www.medtronic.com/carelink/features.html.
`Care Wireless Technology Utilizing PSA’s-Personal Organizers-as
`Patient Monitors.
`“FDA Approves Medtronic CareLink™ Monitor and Software,
`Opening a New Chapter in Patient Management Using Internet Tech-
`nology”, Medtronic News Release dated Jan. 2, 2002.
`
`* cited by examiner
`
`

`

`Case 1:19-cv-11586-FDS Document 324-4 Filed 02/23/22 Page 5 of 20
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`U.S. Patent
`
`Oct. 2, 2012
`
`Sheet 1 of 8
`
`US 8,277,377 B2
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`
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`U.S. Patent
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`Oct. 2, 2012
`
`Sheet 2 of 8
`
`US 8,277,377 B2
`
`
`SCREEN
`
`COMPUTER
`
`STYLUS!
`
`|
`
`

`

`Case 1:19-cv-11586-FDS Document 324-4 Filed 02/23/22 Page 7 of 20
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`U.S. Patent
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`Oct. 2, 2012
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`Sheet 3 of 8
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`US 8,277,377 B2
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`BASE STATION 14
`
`

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`Case 1:19-cv-11586-FDS Document 324-4 Filed 02/23/22 Page 8 of 20
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`U.S. Patent
`
`Oct. 2, 2012
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`Sheet 4 of 8
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`US 8,277,377 B2
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`Case 1:19-cv-11586-FDS Document 324-4 Filed 02/23/22 Page 9 of 20
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`U.S. Patent
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`Oct. 2, 2012
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`Case 1:19-cv-11586-FDS Document 324-4 Filed 02/23/22 Page 10 of 20
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`U.S. Patent
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`Oct. 2, 2012
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`Case 1:19-cv-11586-FDS Document 324-4 Filed 02/23/22 Page 11 of 20
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`U.S. Patent
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`Oct. 2, 2012
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`Sheet 7 of 8
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`US 8,277,377 B2
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`Case 1:19-cv-11586-FDS Document 324-4 Filed 02/23/22 Page 12 of 20
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`Oct. 2, 2012
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`Sheet 8 of 8
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`US 8,277,377 B2
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`US 8,277,377 B2
`
`1
`METHOD AND APPARATUS FOR
`MONITORING EXERCISE WITH WIRELESS
`INTERNET CONNECTIVITY
`
`CROSS-REFERENCE TO RELATED
`APPLICATIONS
`
`This is a continuation of U.S. patent application Ser. No.
`11/649,703, filed Jan. 3, 2007, entitled “Method and Appara-
`tus for Health and Disease Management Combining Patient
`Data Monitoring with Wireless Internet Connectivity,” which
`is a continuation of U.S. patent application Ser. No. 11/184,
`274,filed Jul. 18, 2005, entitled “Method and Apparatus for
`Health and Disease Management Combining Patient Data
`Monitoring with Wireless Internet Connectivity,’ now U.S.
`Pat. No. 7,156,808, which is a continuation of U.S. patent
`application Ser. No. 10/418,845, filed Apr. 18, 2003, now
`USS. Pat. No. 6,936,007, which is a continuation of U.S.
`patent application Ser. No. 09/738,270,filed Dec. 15, 2000,
`now USS. Pat. No. 6,602,191, which is a conversion of U.S.
`Provisional Application Ser. No. 60/172,486, filed Dec. 17,
`1999. The disclosure of each of the prior applications is
`incorporated herein by reference in its entirety.
`
`REFERENCE TO GOVERNMENTAL SUPPORT
`
`(none)
`
`REFERENCE TO MICROFICHE APPENDIX
`
`(none)
`
`FIELD OF THE INVENTION
`
`The present invention relates to monitoring of living sub-
`jects, and more particularly to health-monitoring of persons
`where measured or input health data is communicated by a
`wireless device to and from a software application running on
`an internet-connected server and where the same may be
`studied and processed by the software application, a health
`professional, or the subject.
`
`BACKGROUND OF THE INVENTION
`
`Several attempts have been madein the past to achieve
`efficient
`interactive communication of medical or health
`information between a subject or patient and a reviewer or
`providerofthat information.In particular, communication of
`consumer physiological information has been a subject of
`such attempts. It is noted that in this regard the “reviewer or
`provider of medical or health information” is understood to
`includenot only a physician but also a software application or
`algorithm that may analyze the information.
`Medicalor health information has been made available on
`
`a D-ROMaccessible by a home computer system. This pas-
`sive approach had certain disadvantages. First, although the
`personal computer is prevalent is the United States,
`it is
`generally too expensive for a consumer physiological moni-
`toring system and there are many people whofind it too
`complicated to set up and use for that purpose. High-risk,
`chronically ill patients, responsible for more than half of
`health care costs in the United States and forming the fastest
`growing segment of those requiring health care, are indeed
`the mostlikely not to be able to afford or use a system built
`around a personal computer. In addition, such systems are
`limited in their interactivity to the information stored on the
`CD.
`
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`Previous patents by the Inventor addressed both of these
`disadvantages, as well as the need to reduce health care costs
`through providing educational health care information and
`interactive physiological monitoring in the home environ-
`ment by meansof a user-friendly, interactive system (see,
`e.g., U.S. Pat. Nos. 5,601,435, 6,144,837, and continuations
`thereof).
`These previous patents were based on a video game con-
`sole, or a multimedia player using a conventional television
`screen as the display device to achieve a system which is
`simplerto use than systems based on a personal computer. An
`initial embodimentofthe previous patents utilized a compact
`disc to provide interactive information for disease manage-
`ment.
`
`Even with the advantages provided, these systems limited
`the user to location in which the device was located. Even
`wheredevicesare portable,as in the case ofa laptop computer
`with a modem, an ordinary POTS phoneline must be found
`and used. Where the user’s computer employs a broadband
`connection, such as DSL orsatellite, the choices of location
`are even more limited.
`
`Attempts have been made to remedythis deficiency. For
`example, many telemetry systemsallow a “wireless” distance
`to be placed between a health measuring unit and a remote
`monitoring system. However, such systems are limited in
`their range.
`Other systems have usedcellular telephone technology to
`increase the wireless health monitoring range. However,
`these systems have several deficiencies, such as requiring
`significant modification of the mobile phone. For example,
`USS. Pat. No. 5,772,586, issued Jun. 30, 1998 to Heinononet
`al., discloses a method for monitoring the health ofa patient.
`This system uses a specialized connection between the
`patient health measuring unit and the cellular phone, how-
`ever. The patient health measuring unit is located in the bat-
`tery space of the mobile phone and 1s connected to a commu-
`nication bus of the mobile phone. Other systems have been
`proposed, but these suffer from similar deficiencies in that
`they are not designedto be used with “off-the-shelf” wireless
`devices or health measuring equipment.
`The deploymentof the above systemsalso currently lacks
`employmentoffull back-endserver functionality with which
`to provide a wide range of interactive communication with
`the patient. Instead, such systems, if internet-enabled, are
`often limited to mere one-way non-interactive data transfer
`via a modem. While some systems are more enhanced,
`including that disclosed in U.S. Pat. No. 5,357,427, issued
`Oct. 18, 1994 to Langen,et al., and entitled “Remote Moni-
`toring of High-Risk Patients using Artificial Intelligence”,
`these systems are limited by the wired telecommunications
`infrastructure.
`
`SUMMARY OF THE INVENTION
`
`Embodiments of the present invention overcome one or
`more of the disadvantages of the prior art by providing a
`full-feature health-monitoring system that may wirelessly
`connect to a back-endserver application via the internet. The
`invention allows wireless access to and from a widevariety of
`present medical or health-related instruments and devices,
`while maintaining the capability of connecting to future such
`devices.
`In particular, the invention may be embodied in several
`systems. Two complementary such systems are described
`herein, although extensions to other such systems can be
`envisioned. First, an embodiment of the invention may be
`employed to manage the disease state or condition of a
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`US 8,277,377 B2
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`3
`patient. In this embodiment, the patient may employa health
`monitoring device (““HMD”), in particular a medical device,
`and a wireless connection provides data from the medical
`device for processing via the internet including a review by a
`physician or other health care professional if required.
`In the second embodiment, a health or lifestyle manage-
`ment plan may be implemented. Various health parameters,
`such as thoserelating to nutrition or exercise, may be entered
`into a health monitoring device, in this instance termed an
`“exercise machine”, and the same may be wireless commu-
`nicated to a server. An application may process andstore the
`health parameters, and a health specialist may optionally
`review the same.
`Wireless internet connectivity has many advantages. For
`example, in the first embodiment, a diabetic could connect a
`blood glucose meter to an internet-enabled wireless web
`device (“WWD”) away from home and download data to a
`Diabetes Management Company’s server and, in response,
`receive guidance displayed on the screen (or by voice) about
`choices for the next meal.
`Alternatively, in the second embodiment, a person inter-
`ested in tracking an exercise program may take the WWDto
`the local health club and attach the same to an exercise
`
`machine, send data output from various exercise machines
`over the Internet, and receive a personalized response from
`the server of a company specializing in Health & Lifestyle
`Management. The individual may input caloric content of
`foods eaten, and may further input caloric content of exercise
`performed. In this way, e.g., a person in a weight-loss pro-
`gram maysee in greatdetail whether they are expending more
`calories in the form of exercise than the same individual is
`
`consuming in the form of food.
`In general, in the health management embodiment, the
`system may be employed to monitorthe physiologic status of
`a healthy subject while eating, exercising, or performing
`other activities. For clarity, such devices are termed herein
`“exercise machines”. These may include an electronic body
`weightscale, a body fat gauge, biofeedback devices, physio-
`therapy or chiropractic equipment, blood pressure recorders,
`or the like, or any type ofexercise machine or monitor, includ-
`ing a heart rate monitor, treadmill, rowing machine,stepper,
`or the like.
`
`In moredetail, the present invention provides a method and
`system for assisting patients to manage a disease or maintain
`healthy lifestyle by collecting health-related data and provid-
`ing informationin responseto those data by means ofa WWD
`designedto display interactive information through a connec-
`tion to the Internet. The present invention may be connected
`to various HMDs, both medical and exercise-related in
`nature, and may communicate information via a wireless
`connection such as a wireless Internet connection.
`A major advantage of embodiments ofthe inventionis that
`the samefrees the patient from the constraints of wired sys-
`tems. The same allows users with consumer “off-the-shelf”
`
`wireless devices to significantly extend the range of connec-
`tivity over that ofwired computer,television, or even wireless
`telemetry systems.
`Ina first embodimentofthe present invention, the WWDis
`a web-enabled cellular phone. Hereit is noted that the term
`“web”or “internet” are used interchangeably to refer to the
`internet in general. In a second embodiment, the WWDis a
`palm, handheld, or laptop computer, or a PDA, equipped with
`a wireless modem.Ina third embodiment, the WWD may be
`a hybrid device that combines the functions of a computer,
`PDA andtelephone.
`An adaptoris used ifnecessary to convert the output signal
`ofthe medical monitoring device to a suitable input signal for
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`the WWD. Theadaptor allows connection of the WWDto a
`medical device, exercise machine or other variety of health
`care equipment, and the connection may be madevia several
`techniques. As for wired techniques, a standard parallel bus or
`serial cable may be usedif the input/output ports between the
`HMDand the WWDare appropriate. Otherwise, a suitable
`separate adaptor may be employed.
`The connection mayalso be an input such asa disk drive or
`other media inputfor input of data, a USB port or phone jack
`or other such wired input, again employing an adaptor if
`required.
`infrared (IR), microwaves,
`As for wireless techniques,
`radio frequency (RF), e.g., Bluetooth® or IEEE 802.11 pro-
`tocols, optical techniques including lasers, and other such
`techniques may be used. The patientor subject may also input
`data manually, such as by a stylus, keypad, synchronization
`from a PC,or by various other techniques discussed below.
`A major advantage of the invention is that by use of an
`optional adaptor, the system is compatible with current and
`prior HMDsas well as maintaining a capability of adapting to
`future such systems.
`Other advantagesofthe invention may include one or more
`of the following. An embodiment of the invention may be
`used whena patientis traveling or otherwise awayfrom their
`“wired” means of communication. The invention allows
`
`wireless health-monitoring to the level of accuracy previ-
`ously achieved only by desktop so-called “wired” computer
`systems. The invention is protocol-independent.
`The interaction between a WWDand a back-end server
`
`may provide a major additional advantage in certain embodi-
`ments of the invention. In particular, the relatively small
`amount of memory currently provided on a WWDas com-
`pared to a back-endserverseverely limits the functionality of
`applications running on the WWD,especially in terms of
`computing capacity, processing power, anduserinterface. By
`providing significant application functionality on the back-
`end, less memory and processing capabilities become neces-
`sary on the WWD(i.e., on the “front-end”’). Thus, memory
`may beused in the WWDfor an enhanceduserinterface or for
`other purposes, according to the user requirements.
`In a method according to an embodimentofthe invention,
`the patient connects to a specific Internet site and a software
`program, resident on a remote server located on the Internet,
`downloadsan interactive user interface for that patient and an
`application for the measurementof the physiological data.
`The software may also be downloaded to the WWD from a
`personal computer via a synchronization operation in known
`fashion. The software provides a personalized display for the
`user and configures the WWDto control and monitor devices
`connected via a generic input/output port to the WWD. The
`software may be designedto suit the constraints of the small
`display screens of WWDs. The software, as well as inputs
`from the patient or other inputs, can control the manner,
`content, and display of information presented to the patient,
`and measured or input data can be stored for review by a
`health care provideror by a software algorithm or application.
`The algorithm maybe of varying complexity, from a simple
`program that merely acknowledgesreceipt of information to
`an artificial intelligence algorithm, such as an expert system,
`collaborative filtering system, rules based system, case-based
`reasoning system, or other such artificial intelligence appli-
`cation.
`
`Further information may be providedto or from thepatient,
`including information entered manually. The patient may
`input this information via a personal computer, which then
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`US 8,277,377 B2
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`5
`may downloadthe input information to the WWDvia a syn-
`chronization operation using standard protocols, such as
`those for Palm PDA devices.
`
`The user mayalso input supplemental information via a PC
`connected independently to the server via the internet. Such
`supplemental information may include data thatis difficult or
`inconvenient to input on the WWD. In this way, the patient
`may be afforded a more convenient environment in which to
`manipulate data to supplementthe data input to the WWD.
`The deploymentofvoice processing technology may be used
`to enable an even more convenient user interface: i.e., one to
`whichpatients can talk.
`In all of these respects, the portable aspect of the WWD is
`important: to with, the user may conveniently carry the WWD
`on their person wherever they may go, allowing data entry at
`the time needed.
`
`Other aspects, features, and advantages will be apparent
`from the summary above,as well as from the description that
`follows, including the figures and the claims.
`
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIG. 1 illustrates a general embodiment of a wireless
`health-monitoring system according to the present invention;
`FIG. 2 illustrates an embodiment of a wireless health-
`
`monitoring apparatus according to the present invention,
`showing the system of FIG. 1 up to a point of a wireless
`antenna;
`FIG.3 illustrates an embodimentof a back end of a health-
`
`monitoring system according to the present invention;
`FIG. 4 illustrates a data flow diagram according to an
`embodimentof the present invention;
`FIG.5 illustrates an embodiment of a method of use for a
`
`wireless application and a server application according to the
`present invention, in which the same is implemented for
`disease and patient management;
`FIG.6 illustrates an embodiment of a method of use for a
`
`wireless application and a server application according to the
`present invention, in which the same is implemented for
`health management;
`FIG.7 illustrates an embodiment of a wired connection
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`between a HMD and a WWD,also showing an optional
`adaptor; and
`FIG.8 illustrates an embodiment of a wireless connection
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`between a HMD and a WWD,also showing an optional
`adaptor.
`
`DETAILED DESCRIPTION OF THE PREFERRED
`EMBODIMENTS
`
`Various acronymsare used for clarity herein. Definitions
`are given below.
`The term “HMD” may encompass not only devices with
`physiologic sensors but also devices with a keypad, keyboard,
`mouse,pointer, pressure sensor, or other such inputs that the
`patient or user may employ to perform data entry of the
`desired parameters. In general, HMDs include some means
`for determining a health parameter.
`In a disease management embodiment, an HMD maybe a
`blood glucose monitor, a blood pressure monitor, an ambula-
`tory ECG recorder, a respiratory monitor, a temperature or
`heart rate monitor, and so on.
`In a healthy lifestyle management embodiment, an HMD
`may be an exercise machine, including treadmills, rowers,
`steppers, exercise cycles, or other aerobic or anaerobic exer-
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`cisers, or a monitor, include monitors for temperature, heart
`rate, blood pressure, amount of work or rate of work per-
`formed, etc.
`The term “subject” as used herein primarily indicates a
`human subject. The same may be a medical patient under
`physician care, a person interested in maintaining health via
`accurate recording of nutrition and exercise, and so on. The
`term “user”is generally used to refer to the user of the device,
`which may be synonymouswith the subject or may alterna-
`tively be a caregiver of the subject, etc. The term “patient” is
`used, in addition to a person underthe care of a physician, to
`also refer to a “normal” or healthy individual whois inter-
`ested in ma