`
`In the Inter Partes Review of:
`US. Patent No. 7,921,186
`
`Filed: Feb. 14, 2007
`Issued: Apr. 5, 2011
`
`Inventor: Stephen J. Brown
`
`Trial Number: To Be Assigned
`
`Attorney Docket No.:
`12771 .0106USR5
`
`Assignee: Health Hero Network, Inc.
`
`Title: Networked System For Interactive
`Communication And Remote Monitoring
`Of Individuals
`
`
`DECLARATION BY ROBERT T. STONE, PH.D. REGARDING U.S.
`PATENT NO. 7,921,186 UNDER 37 C.F.R. § 42.63(a)
`
`
`1, Robert T. Stone, Ph.D., do declare and state as follows:
`
`Background and Experience
`
`1.
`
`I received my BS.
`
`in Electrical Engineering from Virginia
`
`Polytechnic Institute and State University in 1977, my MS. in Electrical
`
`Engineering from Virginia Polytechnic Institute and State University in 1979,
`
`and my Ph.D.
`
`in Electrical Engineering from Stanford University in
`
`1981. My studies focused on electronics and signal processing.
`
`2.
`
`I have over thirty years of academic and industry experience in
`
`the field of medical electronics systems and instrumentation.
`
`I have
`
`Bosch Ex. 2067Bosch Ex. 2022
`
`Cardiocom v. Bosch IPR2013-00468Cardiocom v. Bosch IPR2013-00451
`
`Cardiocom Ex. 1007
`
`
`
`extensive experience with remote health monitoring equipment and design,
`
`as well as computer programs for those systems.
`
`3.
`
`While employed at Nellcor Puritan Bennett, Inc. (“Nellcor”),
`
`where I was Manager of Electronic Research from 1983 to 1989, I was the
`
`Lead Program Manager for the development of a patient monitoring system
`
`which allowed remote monitoring of in—hospital patients via a wireless
`
`network. That and virtually all of my work at Nellcor involved embedded
`
`systems level programming and application programming.
`
`4.
`
`Virtually all of my work experience since that time has included
`
`application programming. In 2007 through 2009, I developed a home-based
`
`wireless patient monitoring system that would communicate with a central
`
`server Le. a computer configured to service multiple clients or remote
`
`computers.
`
`5.
`
`6.
`
`Attached to this declaration is a copy of my curriculum vitae.
`
`I am presently the CEO and Founder of Medical Design
`
`Solutions, Inc., which is a consulting firm focusing on all aspects of medical
`
`device research and development.
`
`7.
`
`I am not employed by, nor receiving grant support from,
`
`Cardiocom, LLC, the requester in this inter partes review.
`
`I am receiving
`
`
`
`compensation for my involvement
`
`in this matter based on my standard
`
`hourly consulting fees.
`
`8.
`
`I am competent
`
`to make this declaration based upon my
`
`personal knowledge and technical expertise in the area of remote patient
`
`monitoring as well as script programming.
`
`9.
`
`In preparing this Declaration,
`
`I reviewed US. Patent No.
`
`7,921,186 (hereinafter “the ‘186 Patent” or “Brown”), the file history of the
`
`‘186 Patent, Cardiocom’s Request for Inter Partes Review of the ‘186
`
`Patent, and the cited prior art.
`
`I have also reviewed portions of the Manual
`
`of Patent Examining Procedure, including Sections 2131, 2141-2145, as well
`
`as KSR Int’l Co. v. Teleflex Inc, 550 US. 398, 416-17 (2007). That case,
`
`and the MPEP sections, explain the legal
`
`requirements of inherency,
`
`obviousness and examining procedures relevant
`
`to obviousness.
`
`The
`
`documents I have reviewed are reflected in my analysis.
`
`10.
`
`I was asked for my opinion as to the level of ordinary skill in
`
`the art, construction of claim terms at issue in the ‘186 Patent, and whether
`
`certain claimed inventions, as a Whole, were obvious in view of the specific
`
`prior art I was shown.
`
`
`
`Background of Art
`
`11.
`
`Long before the ‘186 Patent, pressures to incorporate remote
`
`management of health existed. Prior to the filing of the ‘186 Patent, the era
`
`of house calls had ended.
`
`Further,
`
`the cost of facilities, maintenance
`
`overhead, transportation costs, and medical payment methodologies in the
`
`era prior to the ‘186 Patent led to higher costs for routine monitoring of
`
`health status,
`
`increased risks
`
`for
`
`facility based care including cross
`
`contamination by infectious patients, and increasingly costly services due to
`
`the ability to treat disease states in older or more fragile patients.
`
`12.
`
`Systems
`
`and
`
`infrastructure
`
`enabling
`
`effective
`
`remote
`
`monitoring and diagnosis have, meanwhile, developed at an increasing rate.
`
`13.
`
`Telephony has been a ubiquitous service in developed and
`
`developing countries for several decades; and digital data interconnection
`
`has been available via telephone modems for several decades — since at least
`
`the 1970’s, at increasingly faster speeds.
`
`14. Means of remote monitoring for health conditions and disease
`
`status and management of same has been practiced and reported upon to
`
`demonstrate the effectiveness of such practices. Table 1, attached hereto, is
`
`a survey result of literature in the public domain of such studies. These
`
`studies utilized remote monitoring and databases to determine the efficacy
`
`-4-
`
`
`
`and cost savings of remote monitoring for the conditions listed.
`
`15.
`
`In the 1980 and early to mid-19905, all prior to the ‘186 Patent,
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`computer based electronic devices and their utility increasingly appeared in
`
`everyday life. User interfaces were simplified,
`
`icons and symbols were
`
`incorporated for simplicity, voice synthesis, telephone auto-dialing, and e-
`
`mail universally were incorporated into our lifestyle. Home health monitors
`
`(blood pressure, blood glucose,
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`smart scales,
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`spirometers, etc.) were
`
`developed and adapted for early self-monitoring and reporting of chronic
`
`health conditions.
`
`16. Also in the 19903 prior to the ‘186 Patent, hypertext mark—up
`
`language (“HTML”) was adapted into shared documents in research, internet
`
`browsers, and general document preparation, which allowed linking to other
`
`references Without the tedium of direct incorporation of the reference into a
`
`document page. This is a convenience that every internet user is familiar
`
`with — i.e. click on a highlighted word, passage, or icon to be taken to some
`
`other reference for more detailed information or operation.
`
`17.
`
`Similarly,
`
`the utilization of remote programming has been
`
`universal since the incorporation of portable computing devices. With the
`
`development of both hard and floppy computer disk drives concurrently with
`
`the development of higher speed modems, the ability to distribute both
`
`-5-
`
`
`
`computer programs and data by telephone or wireless communications has
`
`flourished. Thus, software updates (program changes), and data distribution
`
`has been applied universally since the early 1990’s.
`
`18.
`
`From the earliest days of computer-based applications, the use
`
`of script programming has been incorporated. The script language first
`
`utilized was a predecessor of UNIX in the 1970’s, followed by DOS, Basic,
`
`Pascal, FORTRAN, etc. Virtually all computer—based systems had the
`
`ability and utilized script
`
`languages to distribute programs, utilizing
`
`interpreters to translate those scripts into machine language instructions.
`
`19. Databases were developed and incorporated in medical research
`
`and patient management beginning in the 1970’s, and eHealth records (i.e.
`
`patient databases) have been in use for many years. General purpose
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`database programs have existed since prior to the 1970’s, and have been
`
`incorporated in medicine for many applications — including imaging and
`
`cancer treatment management.
`
`20.
`
`Thus, by the early 1990’s all of the technology at issue with the
`
`‘ 186 Patent was not only developed, but utilized in widely distributed forms
`
`known to virtually every engineering technologist and medical practitioner.
`
`
`
`One of Ordinary Skill in the Art
`
`21.
`
`In my opinion, one of ordinary skill in the art at the time of the
`
`‘186 Patent would have a bachelor’s degree in Electrical Engineering or
`
`Computer Science, or its equivalent, and at least 2 years of experience with
`
`the design and programming of patient monitoring systems and at least 1
`
`year of experience with the design or programming of networked systems.
`
`Claim Terms
`
`22.
`
`Based on my review of the ‘186 Patent, there are certain terms
`
`used in that patent that are used in the medical field and have particular
`
`meaning in that field.
`
`I was instructed to use what I believe to be the
`
`broadest reasonable construction of the claim terms, read in the context of
`
`the patent.
`
`23.
`
`“Communication Interface”: One of ordinary skill in the art,
`
`using the broadest reasonable construction of the claim term and read in the
`
`context of the patent, would define “communication interface” as “a point of
`
`connection where two or more devices or systems may communicate.”
`
`There is no explicit definition of “communication interface” in the ‘186
`
`Patent. However, there are a number of instances where the term “interface”
`
`is used. See, e.g., ‘186 Patent, col. 6:18-33; col. 11:15-18. Each of those
`
`-7-
`
`
`
`instances is consistent with the definition of interface.
`
`24.
`
`“Script program”: One of ordinary skill in the art, using the
`
`broadest reasonable construction of the claim term and read in the context of
`
`the patent, would define “script program” as “a program including at least
`
`one text command and can be interpreted and performed by a device, such as
`
`a computer.” In computer programming a script program, or script,
`
`is
`
`defined as “a type of program that consists of a set of instructions to an
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`application or a utility program. A script usually consists of instructions
`
`expressed using the application’s or utility’s rules and syntax, combined
`
`with simple control structures such as loops and if/then expressions.”
`
`Microsoft Press Computer Dictionary, 422-23 (Microsoft Press 1997, 3d ed.).
`
`In the context of the ‘186 Patent, a script program is illustrated as user-
`
`recognizable text that can define functions performed by a device, such as a
`
`computing system or other appliance. See ‘186 Patent, Table 1. Furthermore,
`
`as noted in the ‘186 Patent, many different scripting languages could be used.
`
`‘186 Patent, col. 7:51-54. Accordingly, the above definition is consistent
`
`with my understanding of the term as one of ordinary skill in the art.
`
`
`
`Fu/Wahlquist Combination
`
`25.
`
`Fu (US. Patent No. 4,803,625), discloses an apparatus (the
`
`monitor) and its use (i.e., a method for interacting with an individual (a
`
`patient)) regarding compliance With a therapeutic regimen (health related
`
`information). Fu, col. 4:47-55.
`
`26.
`
`Fu discloses an apparatus in communication with a monitoring
`
`device, Where the device and associated method (i) produces physiological
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`information regarding the individual and (ii) transmits the physiological
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`information to the apparatus. Fu, col. 6:13-30; see also FIG. 2b.
`
`27.
`
`Fu discloses a second communication interface that receives
`
`programming information from a server via a communication network and
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`transmits the physiological information from the apparatus to the server Via a
`
`communication network.
`
`Fu, FIGS. 1, 3; col. 527-9; col. 5:19-26. The
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`programming information generated, as disclosed in Fu, comprises a query.
`
`Fu, col. 4:47—53. The programming information also comprises a message
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`corresponding to said individual from a health care professional associated
`
`with said individual. The central unit in Fu communicates a message from a
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`health care professional to the patient. The remote unit receives the message.
`
`It is readily apparent to one of ordinary skill in the art that a message that
`
`includes tests and medication must come from the health care professional.
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`-9-
`
`
`
`Fu,
`
`col.
`
`16:34-47.
`
`The programming information also comprises
`
`information specific to the individual. Fu, col. 16:34-47.
`
`28.
`
`Fu discloses a display for presenting queries, messages, and
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`information to an individual.
`
`Fu, col. 18:22-26.
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`Fu further discloses
`
`displaying a query or message specific to the individual via a display
`
`connected to the apparatus. Fu, col. 10:54-56; see also col. 19:33-44.
`
`29.
`
`Fu discloses an interface wherein the individual may provide
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`responses to a query. Fu, Abstract. Fu also teaches that “[t]he main CPU 64
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`communicates with the patient via a display unit 68, a tone generator 70, a
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`voice synthesizer 72, and a key pad 74.” Fu, col. 5:56-5 8.
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`30.
`
`Fu discloses transmitting the patient’s responses to queries (and
`
`other health related information) to the central unit over a communication
`
`network. Fu, Abstract; col. 527—9; col. 5:19-26. Fu discloses at least one
`
`health care professional computer 24 in signal communication (Fig. 1) with
`
`home healthcare units 60 via modems 22. The modem connection between
`
`the server and home units acts as a communication interface between the
`
`server and the remote apparatus. See also Fu, col. 5:23-24 (“Preferably,
`
`communication [between server and home units] is via a modem”).
`
`31.
`
`Fu discloses programming information and the assignment of
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`programming information related to a health condition of the individual
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`-10-
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`
`
`from the health care professional associated with the individual to that
`
`individual. Fu, col. 4:47—55. Fu characterizes the system as advantageously
`
`providing the patient with fast feedback from medical personnel. Fu, col.
`
`4:63-64. One of ordinary skill in the art would understand that the medical
`
`personnel uses the terminals 30 to enter the following: the questions to be
`
`asked, the physician's test and medication designations, and the expected
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`values for the parameters measured. Fu, col. 7:52-55; col. 8:56—65. The
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`patient information package would be used to enter the “physician selected
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`information,” which identifies the patient, and provide such information as
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`name, age, sex, address, social security number, telephone number, and the
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`like. Fu, col. 8:53-56. Further, the central unit user software (prescription
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`entry package and patient information capture package) is used to generate
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`and assign the "test and medication profiles
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`based on the entered
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`information. Fu, col. 8:56-60. Finally, the communications software of the
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`central unit transmits the test and medication profiles to the "respective
`
`home units 60." Fu, col. 4:63-64; col. 5:36-38; col. 8:4-10.
`
`32.
`
`Fu discloses a home unit and a central unit that is located
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`remotely from the home unit. Fu, col. 5:44-52.
`
`33.
`
`Fu discloses displaying the programming information by
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`execution of a program on the apparatus. Fu, col. 8:18-27.
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`-11-
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`
`
`34.
`
`Fu discloses a custom program that is (a) designed specifically
`
`for
`
`the individual,
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`(b) associated with the individual by a unique
`
`identification code, the patient’s social security number, and (c) configured
`
`to control the peripheral monitoring devices. Fu, col. 8:52-65.
`
`35.
`
`Fu discloses an apparatus in which the query is related to the
`
`health condition of the individual and where the individual provides the
`
`response. Fu, col. 8:30—33; col. 10:54-61; Abstract.
`
`36.
`
`Fu discloses sending programming information via a message
`
`to a patient that is related to the patient’s health condition
`
`Fu, Abstract
`
`(“[T]o prompt a patient to take prescribed medication at prescribed times, to
`
`use the sensors to measure prescribed health parameters, and to supply
`
`answers to selected questions”). Fu also discloses sending programming
`
`information via instructions to a patient that is related to the patient’s health
`
`condition. Fu, col. 10:34—43; see also Abstract. Fu also discloses a patient
`
`responding to prompts (an acknowledgment). Fu, col. 4:50-52; col. 10:54-
`
`57.
`
`37.
`
`Fu discloses that the communication network can be cable
`
`networks, wireless networks, or telephone networks. Fu, col. 16:34-37. Fu
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`discloses that the home computer has a modem that can be connected to a
`
`phone line. Fu, Abstract; col. 6:40-44; col. 14:53-65. Fu also discloses a
`
`-12-
`
`
`
`hardwire link and radio link. Fu, col. 16:34—37. One of ordinary skill in the
`
`art at the time of the invention of the ‘186 Patent would understand that a
`
`hardwire link would include a cable network and that a radio link would
`
`include a wireless network.
`
`38.
`
`Fu discloses at least one health care professional computer 24
`
`in signal communication (Fig. 1) with home healthcare units 60 via modems
`
`22. Fu, col. 7: 49—55. The Computer 24 functions as a server based on its
`
`connectivity with the terminals 30 and home unit 60. The home healthcare
`
`units are capable of receiving data files from a remote server.
`
`39.
`
`Fu discloses that the home unit is a device sufficiently compact
`
`to comprise a handheld device. Pu, 001. 6:52—54. In particular, the home unit
`
`is designed specifically for the individual and is associated with the
`
`individual by a unique identification code,
`
`the patient’s social security
`
`number, and is configured to control the peripheral monitoring devices. Fu,
`
`col. 8:52-65.
`
`40.
`
`Fu discloses sending patient responses from the home unit to
`
`the central unit. Fu, col. 4:52—55. Moreover, Figure 2 shows a key board 76
`
`and a key pad 74 that a patient uses to provide a response to a query, where
`
`the key board 76 and key pad 74 are connected to the apparatus 64. Fu, FIG.
`
`2.
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`-13-
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`
`
`41.
`
`Fu also discloses physicians accessing the patient responses at
`
`the central unit for analysis. Fu, col. 19:42-44. Thus, a person having
`
`ordinary skill in the art would understand that in order for the physician to
`
`view the patient responses,
`
`there must be a user interface enabling the
`
`physician to access the results.
`
`42.
`
`Fu claims storing patient responses in a log and transmitting the
`
`responses to a central location via a communication network. Fu, col. 19:39—
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`44. Fu also describes a computer with storage for instructions to be sent to
`
`the remote device and for data to be received from said remote device. Fu,
`
`col. 7:56-62.
`
`43.
`
`In view of the explicit teachings of Fu, one of ordinary skill in
`
`the art would readily incorporate teachings widely known in the computing
`
`field.
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`Further, because health monitoring was becoming increasingly
`
`computer-driven, programming techniques (e.g., script programs) would be
`
`readily adopted for use in remote health monitoring. For example, it would
`
`be obvious to one of ordinary skill in the art at the time of the invention of
`
`the ‘186 Patent to extend the system of Fu to incorporate a computer
`
`program comprising a custom script program that
`
`is designed for an
`
`individual by using a unique identification code and configured to control a
`
`monitoring device. Virtually every computer system by the mid-19905 and
`
`-14-
`
`
`
`prior to the time of the invention had a script interpreter incorporated. For
`
`example, DOS and its predecessor CPM were script interpreter programs.
`
`Thus, it was advantageous and obvious to use communications systems, at
`
`that time readily available, for distribution and receipt of computer programs,
`
`data, and instructions.
`
`44. Other prior art references within the general field of remote
`
`health monitoring systems contain specific teachings that are highly relevant
`
`to particular elements of the claims of the ‘186 Patent. As such, each of the
`
`claims of the ‘186 Patent are obvious in view of combinations of Fu with
`
`those references, as outlined below.
`
`45. As shown above, the claimed health related query functionality
`
`was known and disclosed in Fu. Not only were the health-related queries
`
`known and disclosed in Fu, the queries were programmed into software,
`
`which queries were then presented to the user when the software was
`
`executed.
`
`46.
`
`The only purported novelty of the claims of the ‘186 Patent was
`
`to create a script program, customized for an individual by a health care
`
`professional associated with that individual, and to send this script program
`
`to the remote device, Where the script program controlled a remote
`
`monitoring device. As discussed in detail below, this modification of Fu
`
`-15-
`
`
`
`with the teachings of Wahlquist (US. Pat. No. 5,367,667) would have been
`
`obvious to one of ordinary skill
`
`in the art at
`
`the time of the alleged
`
`invention.
`
`47. Wahlquist discloses generally sending a diagnostic script
`
`program from a central computer to a remote computer.
`
`48. Wahlquist
`
`also explicitly provides
`
`a
`
`computer program
`
`comprising a custom script program designed specifically for said individual.
`
`Wahlquist, col. 2:17-31.
`
`49. Wahlquist
`
`also explicitly provides
`
`a
`
`computer program
`
`comprising a custom script program associated with said individual by a
`
`unique identification code. Wahlquist, col. 2:10—15.
`
`50. Wahlquist
`
`also explicitly provides
`
`a
`
`computer program
`
`comprising a custom script program configured to perform a remote
`
`diagnostic function. Wahlquist, col. 2:42-49. As discussed more below, it
`
`would have been advantageous to one of ordinary skill in the art at the time
`
`of the invention of the ‘186 Patent to use the script program of Wahlquist in
`
`combination with the system of Fu. For example, Fu distributes queries and
`
`programs
`
`explicitly by floppy disk.
`
`Such programs
`
`are typically
`
`significantly longer than script programs. However, script interpreters were
`
`readily available at the time of invention of the ‘186 Patent, allowing
`
`-16-
`
`
`
`complex programs to be distributed as script files via multiple means,
`
`including modems, floppy disks, and CD ROMS. The advantage for being
`
`able to distribute a program Via a modem in Wahlquist is significantly more
`
`timely interaction and modification of patient treatment protocols, which one
`
`of ordinary skill in the art at the time of the invention of the ‘186 Patent
`
`would have desired and sought out.
`
`51.
`
`The combination of Fu and Wahlquist
`
`teaches all of the
`
`elements of claims 1-6, 8-15 of the ‘186 Patent.
`
`52. Upon review of Wahlquist, one of ordinary skill
`
`in the art
`
`would understand that one could readily send a script program from a central
`
`computer to a remote device for carrying out the known remote health
`
`monitoring functions, including the health-related queries that are described
`
`in detail at columns 8 through 16 of Fu. Writing these queries into a script
`
`program would be a routine task for one of ordinary skill in the art. Sending
`
`the script program from a central computer to a remote home unit would also
`
`be a routine task. Furthermore, since the teachings of Wahlquist were well
`
`known in the field of computing systems, and since features of computing
`
`systems were increasingly integrated into remote health monitoring systems
`
`(such as that disclosed in Fu), the script programs of Wahlquist could readily
`
`be used to transmit the health-related queries of Fu.
`
`Furthermore,
`
`the
`
`-17-
`
`
`
`teachings of Fu and Wahlquist are such that
`
`intercombination of their
`
`features in the manner claimed would have been straightforward; one would
`
`have a reasonable expectation of success in combining the UNIX-based
`
`system of Fu, which was known to be capable of supporting execution of
`
`script programs, with the diagnostic script program features of Wahlquist.
`
`53.
`
`There are explicit teachings in Fu and Wahlquist that suggest
`
`the references’
`
`intercombination. Fu teaches the health related query
`
`functionality. Fu discloses a central computer unit that can be “preferably
`
`programmed with a multi—user, multi-tasking operating system such as the
`
`UNIX system which
`
`includes
`
`suitable
`
`programs
`
`for
`
`receiving
`
`communications from the home units 60, preparing appropriate reports, and
`
`directing appropriate instructions or data files to the respective home units
`
`60.” Fu, col. 8:4-10.
`
`54.
`
`One of ordinary skill
`
`in the art would understand that Fu’s
`
`disclosure of a UNIX operating system including “suitable programs for
`
`directing appropriate instructions or data files to the respective home units”
`
`(Fu, col. 824-10) would include the ability to utilize and generate script
`
`commands,
`
`script
`
`files as well as
`
`the sequential collection of such
`
`commands, in other words, a script program.
`
`-13-
`
`
`
`55.
`
`Script commands are ordinary text human-readable instructions
`
`which a computer can interpret and perform without the intermediate step of
`
`compilation. This was a significant advance developed in the 1970s for
`
`computer applications that enabled a user or a programmer to operate a
`
`computer
`
`system without
`
`generating machine-level
`
`programs
`
`and
`
`instructions. The use of script commands and script programs quickly
`
`became ubiquitous. For example, Fu explicitly discloses the use of modems
`
`between the central computer and the remote units. Fu, col. 6:40-46. These
`
`modems and the described telephone dialing were controlled by script
`
`commands, a fact which would be known to anyone programming such a
`
`device.
`
`56. A script program is at least one text command that has been
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`stored as a file that can be interpreted and performed by the computer.
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`I
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`note that my definition of a “script program” as with other definitions or
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`constructions of terms used in the claims, is based on what I believe to be
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`the broadest reasonable construction of those terms in the context of the
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`patent.
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`I understand that
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`is the proper standard for purposes of these
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`proceedings, and that a different standard may be used in other proceedings
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`such as litigation.
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`-19-
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`
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`57.
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`In the 1980s, one of the most commonly used script programs
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`was BASIC and its derivatives. The BASIC interpreter would interpret and
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`execute script programs line-by-line. All forms of computer applications
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`were developed using this script interpreter technique. Further, BASIC
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`source files (scripts) were often developed using standard text editors,
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`transmitted to another computer by various means including floppy disks,
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`modem, or hard-wired networks. It would have been advantageous to one of
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`ordinary skill in the art at the time of the invention of the ‘186 Patent to use
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`a script program because languages like BASIC were easy to understand and
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`program and were widely known. There is no novelty in the use of script
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`programs versus compiled programs for such development, distribution or
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`execution.
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`I am personally aware of the use of this technology because in
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`the 19705 and 1980s,
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`I personally observed it and participated in such
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`development, distribution, and execution on numerous occasions, including
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`medical diagnostic device programming.
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`58.
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`The ability to utilize script commands, script files, and script
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`programs was the inherent utility of operating systems available at the time
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`of the invention of Fu, such as the UNIX, MS—DOS, PC-DOS or VM
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`operating systems.
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`-20-
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`59.
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`Thus, one of ordinary skill in the art would understand that Fu’s
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`disclosure of a UNIX operating system that includes programs for sending
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`“appropriate instructions and data files” (Fu, col. 8:4-10) to the respective
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`home units could, and very likely would include the generation and sending
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`of script programs to the home units, particularly since the health-related
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`queries disclosed in Fu are repetitive in nature. Fu, cols. 8-12.
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`60.
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`In my opinion, Fu’s disclosure, in and of itself, would make the
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`use of script programs obvious for application to remote health monitoring
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`systems.
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`61.
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`If Fu were not enough, then clearly Fu’s teachings combined
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`with Wahlquist’s teaching of a remote computer system utilizing script
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`programs for performing diagnostic tests make the combination obvious.
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`Wahlquist specifically states that “[i]t will be appreciated that the present
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`invention may be practiced using specialized test files or other hardware
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`installations other than those described above” (Wahlquist, col. 10:36-39),
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`which suggests that the use of script programs to perform remote diagnostics
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`can be used in different types of hardware applications. Further, the script
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`program in Wahlquist is sent from a central database manager computer via
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`a modem to the user’s computer. Wahlquist, col. 5:62-66. One of ordinary
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`skill in the art would have known of Wahlquist and could have readily
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`-21_
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`
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`adapted its use of downloadable script programs for performing remote
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`computer diagnostics to the system of Fu for performing remote patient
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`health monitoring.
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`62. Moreover, it would be obvious to combine Fu and Wahlquist
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`and there were motivations, suggestions and reasons to do so that were
`
`disclosed in the references themselves, as well the knowledge of one of
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`ordinary skill
`
`in the art.
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`In particular, and as cited in MPEP § 2143,
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`teachings
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`in the prior art
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`references, design needs, and background
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`knowledge of methods lead to a predictable combination of Fu and
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`Wahlquist in the manner claimed.
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`63.
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`First, as discussed above, one of ordinary skill in the art at the
`
`time of the invention would have known that the utility of a UNIX operating
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`system was its ability to utilize script commands, script files and script
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`programs. Armed with this knowledge, one of ordinary skill in the art would
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`have a rationale to combine Fu with the script program of Wahlquist because
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`script programming was a known and predictable method of programming
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`with several operating systems,
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`including UNIX.
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`See KSR Int’l Co. v.
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`Teleflex Inc, 550 US. 398, 416—17 (2007) ("The combination of familiar
`
`elements according to known methods is likely to be obvious when it does
`
`79,
`no more than yield predictable results ,
`
`(C
`
`if a technique has been used to
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`-22-
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`
`
`improve one device, and a person of ordinary skill in the art would recognize
`
`that it would improve similar devices in the same way, using the technique is
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`obvious unless its actual application is beyond his or her skill”; “a court
`
`must ask whether the improvement is more than the predictable use of prior
`
`art elements according to their established functions"); MPEP § 2143,
`
`Section III
`
`(“Exemplary rationales that may support a conclusion of
`
`obviousness include: Combining prior art elements according to known
`
`methods to yield predictable results...Use of known technique to improve
`
`similar devices (methods, or products) in the same way...Applying a known
`
`technique to a known device (method, or product) ready for improvement to
`
`yield predictable results [or] Some teaching, suggestion, or motivation in the
`
`prior art that would have led one of ordinary skill to modify the prior art
`
`reference or to combine prior art reference teachings to arrive at the claimed
`
`invention”).
`
`64.
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`Second, Wahlquist states that its script program could be used
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`with other hardware applications, which is a reason or teaching, suggestion,
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`or motivation to combine a script program with the system of Fu. See KSR
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`Int’l C0., 550 US. at 421—22 (the court held that
`
`the Federal Circuit
`
`improperly restricted the analysis to teaching, suggesting, or motivation, but
`
`did not say that
`
`the test was improper); MPEP § 2143 (“Exemplary
`
`-23-
`
`
`
`rationales that may support a conclusion of obviousness include:
`
`...Some
`
`teaching, suggestion, or motivation in the prior art that would have led one
`
`of ordinary skill to modify the prior art reference or to combine prior art
`
`reference teachings to arrive at the claimed invention”).
`
`65.
`
`Third, Fu was filed in 1986, Wahlquist was filed in 1992, and
`
`the ‘186 Patent purports to claim priority to a provisional patent application
`
`filed on March 28, 1997. During that interim 11 year timeframe,
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`two
`
`important
`
`industry trends emerged in all computer and software—related
`
`applications:
`
`1) modem speeds increased up to 100—fold (compared to the
`
`speeds cited by Fu), enabling transmission of programs and data at much
`
`higher rates without penalizing the use of voice telephony; 2) as a result, the
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`distribution means of software and data increasingly migrated from floppy-
`
`disks and CD-ROMS to direct distribution over the telephone or other
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`communication networks. Thus, one of ordinary skill in the art would have
`
`found it obvious to use the teachings of Wahlquist to predictably modify Fu
`
`in order to transmit instructions and data containing known health-related
`
`queries in the form of a script program. KSR Int'l Ca, 550 US. at 417
`
`("When a work is available in one field of endeavor, design incentives and
`
`other market forces can prompt variations of it, either in the same field or a
`
`different one."); MPEP § 2143 (“Exemplary rationales that may support a
`
`-24-
`
`
`
`conclusion of obviousness include:... Known work in one field of endeavor
`
`may prompt variations of it for use in either the same field or a different one
`
`based on design incentives or other market forces if the variations are
`
`predictable to one of ordinary skill in the art”). This is particularly true
`
`since Fu explicitly states that the UNIX—based operating system on the
`
`central computer contained programs for sending instructions and data files
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`to the home units. Fu, col. 8:4-10.
`
`66.
`
`One of ordinary skill in the a