`Case 1:19-cv-11586—FDS Document 168-13 Filed 03/31/21 Page 1 of 7
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` EXHIBIT M
`
`EXHIBIT M
`
`
`
`
`
`'i ml W-lmlflifimmmuul-ummnmim
`
`Case 1:19-cv-11586-FDS Document 168-13 Filed 03/31/21 Page 2 of 7
`w; M Case 1;19-cv-11586-FDS chzilme'mjlfifilq Filed 03/31/21 Page 2 CAI/PWV
`
`55mmlllllllllllllllllllllll
`
`~1'2ELSOI‘
`
`Old
`
`PTO/SB/16 (6-95)
`Approved for use through 04/I 1/98i OMB()651~0037
`Patent and Trademark Office; US DEPARTMENT OF COMMERCE
`
`PROVISIONAL APPLICATION COVER SHEET
`
`This is a request for filing a PROVISIONAL APPLICATION under 37 CFR § l.53(c)
`
`Ea a
`.
`Express Mail label number EL341845416US Date oi‘Deposit December l7. I999
`I03; =5“
`I hereby certify that this paper or fee is being deposited with the United States Postal Service
`3:;
`"Express Mail Post Office to Addressee" service under 37 CFR § 1.10
`on the date indicated above and is addressed to the Assistan
`ommissioner for Patents, Washington, DC 20231. “'Ka
`earn '9—
`
`1:? an
` Drew R. Herndon
`Name of person signing
`Signature
`
`Docket
`Number
`
`.
`
`24450-701
`
`Type a plus sign l
`(+) inside this
`i +
`box
`i
`
`INVENTOR(s)/APPLICANT(5)
`
`
`
`
`
`RESIDENCE (CITY AND EITHER STATE OR
`FOREIGN COUNTRY)
`
`Mill Valley, California USA
`
`
`l
`
`
`
`
`
`I
`
`'
`
`.‘
`LA” NAME
`
`QUY
`
`‘
`i, i,
`I
`b 1““ NAME
`
`Roger
`
`MIDDLE
`INITIAL
`
`1.
`
`
`
`TITLE OF THE INVENTION (280 characters max)
`
`Method and Apparatus for Health and Disease Management Combining Patient
`
`Data Monitoring with Wireless Internet Connectivity
`CORRESPONDENCE ADDRESS
`WILSON SONSINI GOODRICH & ROSATI
`650 Page Mill Road
`Palo Alto, California 943 04-1050
`Telephone: (650) 493—9300
`Facsimile: (650) 493-6811
`
`1
`
`1
`
`ENCLOSED APPLICATION PARTS (check all that apply)
`
`Specification
`Drawing(s)
`
`Number ofPages _3..
`Number ofSheets _2_
`
`l [3
`}
`l D
`
`Small Entity Statement
`Other (specify)
`
`METHOD OF PA YMENT (check one)
`
`A check or money order is enclosed to cover the Provisional filing fees.
`PROVISIONAL FILING
`The Commissioner is hereby authorized to charge filing fees and credit
`FEE AMOUNT (:5)
`Deposit A econ m Number: 23—241 5 (Docket No. 24450—70 I) r
`
`TYPED or PRIN lED NAME Paul Davis
`
`Date: December 17, 1999
`
`REGISTRATION NO. 22294
`
`(if appropriate)
`
`E]
`
`Additional inventors are being named on separately numbered sheets attached hereto.
`PR0 VISIONAL APPLICA TION FILING ONLY
`
`C :WRPORTBIAPALib 1 \DRH\1 1 17525.1
`
`*****M
`PNA-FBOOO3419
`
`
`
`
`
`1
`
`at
`
`Case 1:19-cv-11586-FDS Document 1'68—13 Filed 03/31/21 Page3of7
`Case 1:19-cv-11586-FDS Document 168-13 Filed 03/31/21 Page 3 of 7
`
`
`
`DECLARATION OF INVENTION FOR PROVISIONAL PATENT APPLICATION
`
`Method and Apparatus for Health and Disease Management Combining Patient
`Data Monitoring with Wireless Internet Connectivity
`
`Background of the Invention
`
`Previous inventions by the Inventor addressed the need to reduce health care costs
`through providing educational health care information and interactive physiological
`monitoring in the home environment by means of a user-friendly, interactive system
`(Patent #5,601,435 & CIPS). The previous inventions were based on a video game
`console, or a multimedia player (such as that manufactured by Philips/Magnavox) using a
`conventional television screen as the display device to achieve a system which is simpler
`to use than systems based on a personal computer.
`
`Although the personal computer is prevalent is the US, it is too expensive for a
`consumer physiological monitoring system and there are many people who find it too
`complicated to set up and use for that purpose. High-risk, chronically ill patients, with
`diseases such as diabetes, asthma or cardiac abnormalities are responsible for more than
`half of health care costs in the US and form the fastest growing segment as a result of our
`aging population. However, it is the aging, chronically ill patient who is most likely not
`to be able to afford or use a system built around a personal computer.
`
`The initial embodiment of the previous inventions utilized a compact disc to provide
`interactive information for disease management. In subsequent embodiments, the
`information could also be delivered from a server via a multimedia appliance with an
`Internet connection to the World Wide Web. The advent of television sets With built-in
`connections to the Internet (e.g. WebTV) provided yet another embodiment. Various
`medical devices, such as a blood glucose monitor, blood pressure recorder, respiratory
`flow meter or ambulatory ECG recorder, could be connected to the system. The data from
`the medical devices could control the display of information presented to the patient and
`be stored for review by a health care provider.
`
`With the growing adoption of the Internet, there has been a rapid increase in the number
`of patients using it to obtain health care information relating to both the management of
`diseases such as diabetes, or to the development of a healthy life style, such as by
`exercise and diet. There are thousands of health care related web sites available and there
`are many companies collecting health care information and providing interactive
`information to patients via the Internet.
`
`The advent of technology for wireless Internet connectivity enables an alternative system
`for interactive physiological monitoring and providing health—related information that is
`even less expensive and easier to use than one based on a television display. In addition,
`
`PNA-FBOOO3420
`
`
`
`
`
`;»
`
`i
`
`
`
`a
`
`Case 1:19-cv-11586-FDS Document 168-13 Filed 03/31/21 Page 4 of 7
`Case 1:19-cv-11586-FDS Document 168-13 Filed 03/31/21 Page 4 of 7
`
`the deployment of voice processing technology will enable the ultimate user interface: i.e.
`one to which patients can talk. One type of a wireless web device (WWD) currently
`available is the personal digital assistant (PDA) equipped with a Wireless modem (e. g.
`Palm Pilot). Anther type of WWD is the web-enabled cell—phone (WEP) and the new
`generation of WEPs also offers a voice-activated interface. A third type of WWD under
`development is a combination of both a computer and a cell-phone.
`
`Software can be downloaded to the WWD from a server to provide a personalized display
`for the user, update information from health and disease management service companies,
`and control devices connected via a dataport to the WWD. The information supplied by
`health care web sites must be specially designed to suit the constraints of the small
`display screens of WWDs. However, the early adoption of such devices in Europe has
`demonstrated that their use to display information derived from the web is acceptable to
`consumers.
`
`Wireless Internet connectivity has the advantage that the patient is not constrained to the
`place where the personal computer, information appliance or television set is located.
`For example, a diabetic could connect a blood glucose meter to a web-enabled cell phone
`while 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, the same person may take the WWD to the local
`gymnasium, 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 connection of the WWD to a medical device, exercise
`machine or other health care equipment could be via a standardized data port, an adapter
`to extant interfaces such as R8232, infra red, radio frequency, or by default, the patient
`inputting data on the keypad.
`
`Several companies have developed interactive voice response systems (IVR) for disease
`management which use extensive telephone menu trees, but these do not provide for
`connections to medical devices or the interactive display of data. Other companies
`provide medical devices equipped with modems, but these also do not provide the
`interactive display of health management information. Some companies (e.g. Health Hero
`Network Inc.) do offer systems with medical devices connected to the Internet to collect
`data and provide interactive patient information. However, these systems use a personal
`computer, a television screen, or proprietary appliance for the user interface and not a
`WWD; hence they are more expensive, more complicated to use, and lack mobility in
`comparison to the present invention.
`
`Summary of the Invention
`
`The present invention is a method and system for assisting patients to manage a disease
`or maintain a healthy lifestyle by collecting patient data and providing information in
`response to those data by means of a wireless device designed to display interactive
`information through an connection to the Internet.
`
`PNA-FBOOO3421
`
`
`
`Case 1:19-cv-11586-FDS Document 168-13 Filed 03/31/21 Page 5 of 7
`Case 1:19-cv-11586-FDS Document 168-13 'Filed 03/31/21 Page 5 of 7
`
`In the preferred embodiment of the present invention, a web-enabled wireless phone (cg.
`Sprint PCS Phone) is coupled to a medical monitoring device, such as (but not limited to)
`a blood glucose meter. An adapter is used if necessary to convert the output signal of the
`medical data monitor to a suitable input signal for the phone. The patient connects to a
`specific Internet site and a software program, resident on a remote server located on the
`Internet, downloads an interactive user interface for that patient and the measurement of
`the physiological data. Further information may be provided to the patient in response to
`the data or to other inputs that have been entered by voice or keypad.
`
`In place of a conventional medical monitoring device, the web-enabled Wireless phone
`may be coupled to other devices which provide health related information data, such as
`an electronic scale, a body fat gauge, biofeedback devices, physio—therapy or chiropractic
`equipment, or any type of exercise machine. The user connects to the Internet and a
`software program, resident on a remote server located on the Internet, captures data from
`the coupled device and downloads interactive information that relates to health
`management. Further information may be provided to the user in response to the data or
`to other inputs that have been entered by voice or keypad.
`
`In an alternative embodiment of the present invention the web—enabled Wireless phone is
`replaced in the above applications by a palm computer or “personal digital assistant”
`(FDA) that is equipped with a wireless modem and a web interface (e. g., the Palm Pilot
`Internet models).
`
`In an alternative embodiment of the present invention, the web-enabled wireless phone,
`or wireless PDA, is replaced in the above applications by a device that combines the
`functions of a computer, PDA and a telephone, such as the next generation of cell-phones
`or satellite phones that have been demonstrated by several manufacturers.
`
`Inventor
`
`I hereby declare that I am the Inventor of the above—described invention on this date.
`
`Signed,
`
`
`
`
`
`
`Roger J. Quy PhD.
`
`Date, NOW 56“,
`
`\o\0\o\
`
`PNA-FBOOO3422
`
`
`
`Case 1:19-cv-11586-FDS Document 168-13 Filed 03/31/21 Page 6 of 7
`@XHKS \T Cfi‘e 1:19-cv-11586-FDS Document 168-13 Filed 03/31/21 Page 6 of 7
`
`
`
`
`
`f WMQE LESS
`
`;
`
`MMERNET
`
`Sv$T€AA
`
`
`
`- WEE-{*ENkfi LED
`
`W\‘R€L€$$
`
`INTERPfiLg
`
`“\RDNPVSR
`
`l? NE®€D
`
`wemm- RELfiTE b
`
`MON\TOR\ ML:
`
`DEN \ce
`
`PNA-FBOOO3423
`
`
`
`Case 1:19-cv-11586-FDS Document 168-13 Filed 03/31/21 Page 7 of 7
`wwa‘mewwcase‘ngg'fiV‘11585-FDS Document 168-13 Filed 03/31/21 page70fm,mm
`
`
`
` .hi,V.x,if::a.4.._
`
`.5f1
`
`£in,.
`
`‘ ”5‘
`"‘ ,3
`3):: 3% (,v
`
`fi
`
`m.
`
`L...m
`
`z:..5
`
`¥pwmwxmwww<0
`
`.fixMaxww
`
`__ .:8:5:<0:9
`
`
`
`,H,._.MMM
`
`Mw>
`
`PNA-FBOOO3424
`
`
`
`
`