IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In the Inter Partes Review of:
`U.S. Patent No. 7,516,192
`
`Filed: Jul. 14, 2006
`Issued: Apr. 7, 2009
`
`Trial Number: To Be Assigned
`
`Attorney Docket Nos.:
`12771.106USR2
`
`Inventor: Stephen J. Brown
`
`12771.106USR6
`
`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. 7,516,192 UNDER 37 C.F.R. § 4263(3)
`
`
`I, 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.
`
`Bosch Ex. 2021
`I have over thirty years of academic and industry experience in
`Cardiocom v. Bosch IPR2013-00451
`the field of medical electronics systems and instrumentation.
`I have
`
`
`
`In the Inter Partes Review of:
`U.S. Patent No. 7,516,192
`
`Filed: Jul. 14, 2006
`Issued: Apr. 7, 2009
`
`Trial Number: To Be Assigned
`
`Attorney Docket Nos.:
`12771.106USR2
`
`Inventor: Stephen J. Brown
`
`12771.106USR6
`
`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. 7,516,192 UNDER 37 C.F.R. § 4263(3)
`
`
`I, 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.
`
`Bosch Ex. 2021
`I have over thirty years of academic and industry experience in
`Cardiocom v. Bosch IPR2013-00451
`the field of medical electronics systems and instrumentation.
`I have
`
`
`
`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 ie. 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.
`
`7,516,192 (hereinafter “the ‘192 Patent” or “‘Brown”), the file history of the
`
`‘ 192 Patent, and the prior art cited as part of Cardiocom’s Request for Inter
`
`Partes Review of the ‘192 Patent.
`
`1 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 U.S. 398 (2007). That case, and
`
`the MPEP sections,
`
`explain the
`
`legal
`
`requirements of anticipation,
`
`obviousness and examining procedures relevant
`
`to obviousness.
`
`The
`
`documents I have reviewed are reflected in my analysis.
`
`10.
`
`l was asked for my opinion as to the level of ordinary skill in
`
`the art, construction of claim terms at issue in the ‘192 Patent, and whether
`
`certain claimed inventions, as a whole, were obvious in View of the specific
`
`prior art I was shown.
`
`11.
`
`I was asked for my opinion as to the level of ordinary skill in
`
`the art, construction of claim terms at issue in the ‘192 Patent, and whether
`
`
`
`certain claimed inventions, as a whole, were obvious in view of the specific
`
`prior art I was shown.
`
`Background of Art
`
`12.
`
`Long before the time of the filing of the ‘ 192 Patent, there was
`
`pressure on the healthcare system to contain costs, increase quality of care,
`
`and provide greater access to healthcare. Since at least the early 1980s, the
`
`cost of healthcare increased faster than GDP. There has also been increased
`
`public awareness of geographical disparities in healthcare treatment, as well
`
`as the common occurrence of medical errors.
`
`13.
`
`Long before the time of the filing of the ‘192 Patent, pressures
`
`to incorporate remote management of health existed. 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 ‘192 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.
`
`14.
`
`Systems
`
`and
`
`infrastructure
`
`enabling
`
`effective
`
`remote
`
`monitoring and diagnosis have, meanwhile, developed at an increasing rate.
`
`15.
`
`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.
`
`16. 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
`
`and cost savings of remote monitoring for the conditions listed.
`
`17.
`
`In the 1980 and early to mid-19903, all prior to the ‘ 192 Patent,
`
`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,
`
`smart
`
`scales,
`
`spirometers, etc.) were
`
`developed and adapted for early self—monitoring and reporting of chronic
`
`health conditions.
`
`18. Also in the 19905 prior to the ‘192 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.
`
`19.
`
`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
`
`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.
`
`20.
`
`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.
`
`21. 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
`
`
`
`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.
`
`22.
`
`Thus, by the early 1990’s all of the technology at issue with the
`
`‘ 192 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
`
`23.
`
`In my opinion, one of ordinary skill in the art at the time of the
`
`‘192 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
`
`24.
`
`Based on my review of the ‘192 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.
`
`25.
`
`“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
`
`application or a utility program. A script usually consists of instructions
`
`expressed using the application’s or utility’s rules and syntax, combined
`
`with
`
`control
`
`structures
`
`such
`
`as
`
`simple
`9
`expressions.” Microsoft Press Computer Dictionary, 422—23 (Microsoft
`
`loops
`
`and
`
`if/then
`
`Press 1997, 3d ed).
`
`In the context of the ‘192 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 “192 Patent,
`
`Table 1. Furthermore, as noted in the ‘192 Patent, many different scripting
`
`languages could be used.
`
`‘192 Patent, col. 7:52-55. Accordingly, the above
`
`definition is consistent with my understanding of the term as one of ordinary
`
`skill in the art.
`
`26.
`
`“Data Merge 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 “data merge program” as “software that
`
`combines two or more sets of items into one.” In computing systems, a
`
`“merge” corresponds to “combin[ing] two or more sets of items into one,
`
`
`
`usually in a specified sequence.” IEEE Standard Dictionary of Electrical
`
`and Electronics Terms, (4th Ed. 1992) at p. 483.
`
`Intrinsic support for that
`
`definition includes Brown’s disclosure that a data merge program is for
`
`“merging the data stored in table 46 with generic script programs 40.” ‘192
`
`Patent, col. 13:7—9. This definition is consistent with my understanding of
`
`the term as one of ordinary skill in the art.
`
`27.
`
`“Script Assignment Unit”: 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 assignment unit” as “a software
`
`module that associates a script program with an individual.”
`
`Intrinsic
`
`support for that definition includes Brown’s disclosure that a “script assignor”
`
`assigns a script program to a patient, e.g., by creating a pointer to the script
`
`program and storing or associating the pointer with a unique identification
`
`code for the patient.
`
`‘ 192 Patent, col. 13:62-67. This definition is consistent
`
`with my understanding of the term as one of ordinary skill in the art.
`
`28.
`
`“Pointer”: 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 “pointer” as “an identifier that indicates the location of
`
`an item of data.” lEEE Standard Dictionary of Electrical and Electronics
`
`Terms,
`
`(4th Ed. 1992) at p. 703. This definition is consistent with my
`
`
`
`understanding of the term as one of ordinary skill in the art. This definition
`
`is consistent with my understanding of the term as one of ordinary skill in
`
`the art.
`
`Wright Jr.
`
`29. US. Pat. No. 5,704,029 (“Wright Jr”) teaches all of the
`
`elements of claims 1—3, 6—7, 11-12, 17-23, 29—30 and 35-36 of the ‘192
`
`Patent. Wright Jr. discloses a system comprising a personal computer
`
`connected over a network to one or more remote devices. Wright Jr., Fig. 1;
`
`col. 3:28-40; col. 924—6. Wright Jr. also discloses creating an executable
`
`form driven by field scripts to collect data from a remote user. Wright Jr.,
`
`col. 924-6; col. 9:11—26; col. 13:39-53.
`
`30.
`
`The disclosure of scripts in Wright Jr. is particularly important
`
`because it was the lack of disclosure of generating a customized script
`
`program by customizing a generic script program, and including a display
`
`and input command for a remote apparatus,
`
`that formed the basis for
`
`allowance for the ‘ 192 patent.
`
`In fact, many of the claims of the ‘192 patent
`
`have nothing to do with remote patient monitoring.
`
`31. Wright Jr. discloses a system for communicating with at least
`
`one individual. Wright Jr., Fig. 1; col. 3:28—40. Wright Jr. discloses a
`
`system for communicating with at least one individual that is comprised of a
`
`
`
`personal computer configured to create and communicate a program/script
`
`targeted at a specific individual on a remote device known as a personal
`
`digital assistant, or PDA. See Wright Jr., 122 Fig. l.
`
`32. Wright Jr. discloses a computer configured to communicate
`
`with at least one remotely situated apparatus. Wright, Jr. discloses a system
`
`in which a personal computer (PC) is communicatively connected to a
`
`remote handheld computer, e.g., a PDA. Wright Jr., Fig. 1; col. 6:40—45; col.
`
`6:62-67 (“modems or wireless technology. . .may be used for communication
`
`between the PDA 104 and computer 102”).
`
`33. Wright
`
`Jr.
`
`inherently
`
`discloses
`
`a
`
`user
`
`interface
`
`in
`
`communication with the computer. Wright Jr., col. 8:8—20; col. 7:54-56.
`
`Wright Jr. inherently discloses a user interface in communication with the
`
`computer for entering, authoring, selecting, or some combination thereof, a
`
`message, query, or response choices. Wright Jr., col. 8:15-col. 13:23
`
`(detailing the process of creating a form). For example, Wright Jr. provides a
`
`detailed example of a designer selecting or entering messages, queries or
`
`response choices for the script program. See, e. g, Wright Jr., col. 9:58-60;
`
`col. 10:46—52.
`
`Included within that example are several instances in which
`
`the forms creator queries the designer for information and allows the
`
`designer to make selections or enter text for messages or questions. See, e. g.,
`
`
`
`Wright Jr., col. 10:46—50; cols. 11:48—12:10. Moreover, the forms creator
`
`allows the designer to select a number of responses allowed and enter
`
`answer choices. See, eg, Wright Jr., cols. 10:53—11:10; cols. 12:63-13:12.
`
`34. Wright Jr. discloses a data merge program configured to
`
`generate a customized script program by customizing a generic script
`
`program. Wright Jr. discloses, for example, a field editor (or data merge
`
`program) associated with a form creation program that is configured to
`
`generate a customized script program by customizing a generic script
`
`program. Wright Jr., col. 6:33-40; col. 9:51—60. Wright Jr. provides that ifa
`
`previous form (e.g., generic script program) needs to be revised or
`
`customized, a forms designer (or user) creates the form and then customizes
`
`it using a field editor.
`
`See Wright Jr., col. 6: 33-40; col. 9:51—60.
`
`Specifically, to customize a previous form, Wright Jr. provides a dialog box
`
`that prompts the user for a form to duplicate from a list of existing forms.
`
`After selection, a new form is created and a new form number is assigned.
`
`This allows the user to create a derivative form without reentering all form
`
`information from the previous form.
`
`See Wright Jr., col. 8: 32-38.
`
`Thereafter, the field editor enables a user to edit or customize fields for the
`
`new form,
`
`thereby customizing a generic script program to generate a
`
`customized script program. Wright Jr., col. 9:51—60; col. 27:56—62.
`
`
`
`35. Wright Jr. describes a data merge program that obtains data
`
`from a first file and inserts the data into a second, existing file to generate a
`
`customized file. Specifically, Wright Jr. teaches a field editor that obtains
`
`data based on user selections from a first file (e.g., containing selection
`
`choices) and inserts the data into fields of a second, existing form to
`
`generate a customized form. Wright Jr., col. 9:52—60.
`
`36. Wright Jr. discloses a customized script program that is to be
`
`executed by the remotely situated apparatus. Wright Jr. provides that the
`
`PDA includes a memory and further discloses that the forms are stored on
`
`the memory in the PDA. Wright Jr., col. 6:40—61; col. 13:39—53. The
`
`execution of the form is driven by script programs, which are written in a
`
`scripting language, and include flow control statements and functions for
`
`controlling execution of the form. Wright Jr., col. 9:11—26. Wright Jr.
`
`discloses that data representing a customized form (e.g., customized script
`
`program) is sent from the PC to a portable computerized device, such as a
`
`PDA. Wright Jr., col. 3:28—40; col. 13:25—36; col. 13:39—46.
`
`37. Wright Jr. discloses a display command to present
`
`to the
`
`individual messages, queries, or response choices, and an input command to
`
`receive responses when the customized script program includes presentation
`
`of one or more queries. Wright Jr., col. 4:49-61; col. 7:6-25. Wright Jr. also
`
`
`
`discloses an executable form (e. g., customized script program) that includes
`
`display commands for presenting messages, queries, or response choices,
`
`and input commands for accepting responses selected by a user. Wright Jr.
`
`col. 7:6—25.
`
`38. Wright Jr.
`
`teaches that a new form (e.g., customized script
`
`program) includes a command to display a message or a query upon
`
`receiving a response. For example, Wright Jr. describes displaying one
`
`question or statement (and if appropriate, a corresponding set of possible
`
`answers or responses) at a time on the display screen of the PDA. Wright Jr.,
`
`col. 7:6-10. Moreover, Wright Jr. provides that when a user answers each
`
`question, thereby providing response data, the forms engine executes a script
`
`program for that question and may perform data validation, sound an alarm,
`
`display a message, quit, launch another form, skip to another question, and
`
`so forth. Wright Jr., col. 7:14-18. Wright Jr. teaches that the script allows
`
`the forms designer to go to another question based on the previous answer(s).
`
`Wright Jr., col. 7:18—23.
`
`39. Wright Jr. discloses one or more databases accessible by the
`
`data merge program for storing the generic script program and any responses
`
`received from the remotely situated apparatus. Wright Jr., col. 8:32-38; col.
`
`3:28-40; col. 527-15; col. 14:1-10. Upon transmitting a form to a PDA for
`
`
`
`execution, a user provides responses to the questions in the form and the
`
`responses are then transmitted from the PDA to the personal computer.
`
`Wright Jr., col. 3:28-40. The responses are stored on the personal computer
`
`in a tab-delimited format for use with a database. Wright Jr., col. 527-15;
`
`col. 14:1—10.
`
`40. Wright Jr. discloses a system configured to communicate with a
`
`plurality of individuals using a corresponding plurality of remotely situated
`
`apparatuses. Wright Jr., col. 3:28-40; col. 9:4—9. Wright, Jr. discloses a
`
`system in which a computer is communicatively connected to a remote PDA.
`
`Wright Jr., Fig. 1; col. 6:33-46; col. 6:62—67. Wright Jr. further provides that
`
`multiple PDAs may be connected to the PC and that each PDA is associated
`
`with a user who completes a form downloaded from the PC. Wright Jr., col.
`
`3:28—40; col. 924—9.
`
`41. Wright Jr. also discloses a system in which a personal computer
`
`(PC) is communicatively connected, e.g., via a cable modem or wireless
`
`technologies,
`
`to a remote handheld computer, e.g., a personal digital
`
`assistant (PDA). See Wright Jr., Fig. 1; col. 6:33—46, 62—67. Wright Jr.
`
`further provides that multiple PDAs may be connected to the PC and that
`
`each PDA is associated with a user who completes a form downloaded from
`
`the PC. Wright Jr., col. 3:28-40; col. 9:4-9. Thus, Wright Jr. teaches a
`
`
`
`system for communicating with a plurality of
`
`individuals using a
`
`corresponding plurality of remotes PDAs.
`
`42. Wright Jr. discloses one or more databases further configured
`
`for storing a plurality of customized script programs. Wright Jr., col. 8:32-
`
`38. For example, Wright Jr. teaches that a new form (e.g., a customized
`
`script program) may be customized based on selecting from a plurality of
`
`existing forms (e.g., a plurality of generic script programs). See Wright Jr.,
`
`col. 8:32—38. Wright Jr. also discloses that each customized form is stored
`
`on a PC, i.e., a new form is created with the name “Duplicate of ‘Previous
`
`Name’” and assigned a new form number. Wright Jr., col. 8:32-38.
`
`Therefore, it follows that a plurality of customized forms may be generated
`
`based on the plurality of existing, or generic, forms.
`
`43. Wright Jr.
`
`teaches that a new form (i.e., customized script
`
`program) is identified with a new form number and that the new form is
`
`filled out by the user of a remote PDA. Wright Jr., col. 3:28-40; col. 8:32-
`
`38. Wright Jr. also teaches that the system could be used to automate a
`
`personality profile based on a line of questioning. Wright Jr, col. 28:40-44.
`
`One of ordinary skill in the art would understand that in order to automate a
`
`user’s personality profile,
`
`it would be necessary to associate or assign a
`
`
`
`customized form with the user or users to collect data regarding the line of
`
`questioning.
`
`44. Wright Jr. discloses communication with a plurality of users.
`
`Wright Jr., col. 3:28-40; col. 9:4—9.
`
`It also contemplates automating a
`
`personality profile based on a line of questioning. Wright Jr., col. 28:40-44.
`
`Because Wright Jr. discloses communicating with a plurality of users and
`
`automating a personality profile, it would be obvious to one of ordinary skill
`
`to automate personality profiles for a plurality of users. One of ordinary
`
`skill
`
`in the art would understand that
`
`in order to automate personality
`
`profiles for a plurality of users, it would be necessary to store a list of the
`
`users for whom personality profiles were automated. Such an extension
`
`would be obvious to one having ordinary skill in the art because it would
`
`simplify organizational efficiency to have a list of users.
`
`45. Wright Jr. also discloses that when a device sends a form data
`
`array containing the responses by the user to the computer, the first item in
`
`the form data array is a form identification for identifying the form that the
`
`data is associated with. Wright Jr., col. 3:34-40. Thus, if the system of
`
`Wright Jr. were extended to assign a customized form to a particular user, it
`
`would be obvious and advantageous to extend the system of Wright Jr. to
`
`
`
`store a list of the particular users and a pointer (e.g., a form identification) to
`
`the customized form assigned to each user.
`
`46. Wright Jr. discloses a system where the customized script
`
`programs are generated using one or more generic script programs. Wright
`
`Jr., col. 8:32—38. Wright Jr. teaches that a new form (e.g., customized script
`
`program) may be customized based on selecting from a plurality of existing
`
`forms (e.g., a plurality of generic script programs). Wright Jr., col. 8:32-38.
`
`Therefore, it follows that a plurality of customized forms may be generated
`
`based on the plurality of existing, or generic, forms.
`
`47. Wright Jr. discloses a system where the messages comprise a
`
`question or statement (Wright Jr., col. 726-10), information of benefit to the
`
`individual, and reminders or prompts. Wright Jr., col. 27:56-62. Wright Jr.
`
`discloses that displayed messages include a question or statement, and if
`
`appropriate, a corresponding set of possible answers or responses. Wright
`
`Jr., col. 7:6—10. Wright Jr. also teaches displaying information of benefit to
`
`the individual, e.g., display of a “help” message, and reminders or prompts.
`
`Wright Jr., col. 10:37-41; col. 27:56-62.
`
`48. Wright Jr.
`
`teaches that
`
`the PDA sends a form data array
`
`containing responses from the user, e.g., personal data, to the PC. Wright Jr.,
`
`col. 3:34—40. Moreover, Wright Jr. provides that after transferring the form
`
`
`
`data to the PC, it is sorted by form and saved to disk, preferably in a tab-
`
`delimited format, where it is available for use with spreadsheets, databases,
`
`tabulation packages, and other programs. Wright Jr., col. 1421-10. Thus,
`
`Wright Jr. teaches storage of personal data (e.g., user responses) by form in a
`
`tab—delimited format, which is an obvious variant of a look—up table.
`
`49. Wright Jr. provides that after transferring a form data array
`
`containing user responses (e.g., personal data)
`
`from the PDA to the
`
`computer, the personal data is sorted by form and saved to disk, preferably
`
`in a tab—delimited format, where it is available for use with spreadsheets,
`
`databases, tabulation packages, and other programs. Wright Jr., col. 3:34-
`
`40; col. 14:1—10. Thus, Wright Jr. teaches storage of personal data in a tab-
`
`delimited format that is available to a database, which is an obvious variant
`
`to storing personal data in a look—up table that is part ofa database.
`
`50. Wright Jr. discloses a system where the computer further
`
`comprises a script generator for generating the generic script programs.
`
`Wright Jr., col. 3:28—40; col. 6:33—40; col. 7:14-23. Wright Jr. teaches a
`
`forms creation program (e.g., script generator) for creating executable forms
`
`(e.g., generic script programs) that uSe embedded scripts to control
`
`the
`
`display of questions, record user responses, and transmit
`
`the recorded
`
`
`
`responses to a PC, as well as provide other functions associated with the
`
`form. Wright Jr., col. 3:28—40; col. 6:33—40; col. 7:14-23.
`
`51. Wright Jr. discloses a data merge program generating the
`
`customized script program using the generic script program as a template.
`
`Wright Jr., col. 8: 32-38; col. 9:51—60; col. 27:56—62. Wright Jr. describes a
`
`field editor (or data merge program) that
`
`is configured to customize a
`
`previous form by selecting a form to duplicate (e.g., as a template) from a
`
`list of existing forms, which enables the user to create a derivative form
`
`without reentering all form information from the previous form. Wright Jr.,
`
`col. 8: 32-38. Thereafter, the field editor enables a user to edit or customize
`
`fields for the derivative form. Wright Jr., col. 9:51-60; col. 27:56-62. Thus,
`
`Wright Jr. also discloses generating a customized script program in the
`
`computer by customizing the generic script program.
`
`52. Wright Jr. discloses a generic script program comprising at
`
`least one insert command specifying types of personal data to be inserted by
`
`the data merge program. Wright Jr. describes a field editor (e.g., data merge
`
`program) that enables a designer to edit field attributes for an existing form
`
`(e.g., generic script program). Wright Jr., col. 8: 28—31; col. 9:51-60. For
`
`each field, the designer specifies certain attributes including field type, a
`
`question or prompt, a list of answer choices, a help message, a control script,
`
`
`
`and others. Wright Jr., col. 27:56—62. Based on the number of answers
`
`selected by the form designer for a particular query, “offsets” (i.e., insert
`
`commands) are automatically provided in the generic script program that
`
`correspond to locations in the form data array where the user selections (e.g.,
`
`personal data) will be inserted or stored. Wright Jr., col. 12:25-51; cols.
`
`12:65-13:12. The types of user selections available, i.e., types of personal
`
`data, may also be defined by the form designer using the field editor.
`
`Wright Jr., col. 9:58-60; col. 27:56—62.
`
`53. Wright
`
`Jr. discloses a generic script program comprising
`
`messages to be presented to the user, questions to be answered by the user,
`
`and response choices to be selected by the user. Wright Jr., col. 4:49-61; col.
`
`7 :6—25.
`
`54. Wright Jr. discloses generating the generic script program
`
`comprising entering or selecting messages, queries or response choices for
`
`the script program. Wright Jr. discloses a forms creation program whereby a
`
`designer selects or enters messages, queries or response choices for creating
`
`an executable form (or script program). Wright Jr., col. 6:33—39; col. 10:46—
`
`50; cols. 11:48-12:10. Moreover, the forms creator allows the designer to
`
`select a number of responses allowed and enter answer choices. Wright Jr.,
`
`cols. 10:53-11:10; cols. 12:63—13:12.
`
`
`
`Goodman/Wright Jr. Combination
`
`55. US. Patent No. 5,827,180 (“Goodman”) discloses a host
`
`computer that communicates and a method to communicate with patient
`
`nodes and health care providers via a communication link. Goodman, col.
`
`3:54-59. The data processors of the patient nodes download information to
`
`and receive information from messaging devices. Goodman, col. 3:60—64.
`
`Data obtained from the medical devices is stored and uploaded to the host
`
`computer. Goodman, col. 7:34—42.
`
`56.
`
`Goodman provides a personal health network (“PHN”) that
`
`includes a host computer that receives a treatment plan for a particular
`
`patient from a health care provider and generates an algorithm for collecting
`
`patient data and communicating with the patient. Goodman, col. 2:54-65.
`
`When executed by a remote messaging device, the algorithm controls the
`
`messaging device to display messages and queries to the patient that are
`
`based at least in part on the treatment plan received from the health care
`
`provider. Goodman, col. 525-8; col. 5:13-24; col. 5:30—42; col. 8:45—61; col.
`
`10:37—60.
`
`57.
`
`One of ordinary skill in the art would be motivated to combine
`
`Wright Jr’s script programs with the system of Goodman because script
`
`programs have many advantages, including, for example, suitability of script
`
`
`
`programs for survey functions and accurate data collection, flexibility and
`
`ease of use in creating generic and customized script programs, user—friendly
`
`navigation of script programs during execution on remote devices,
`
`suitability for displaying prompts and messages to a user, and for accepting
`
`input and displaying messages based on the input, and suitability for
`
`collection, transmission, and analysis of user response data.
`
`58.
`
`Goodman discloses a monitoring system for communicating
`
`with at least one individual,
`
`i.e., a personal health network (“PHN”) for
`
`“collecting and routing information pertaining to the health care of a patient
`
`to the patient and the health care provider.” Goodman, Abstract.
`
`59.
`
`Goodman discloses a computer configured to communicate
`
`with at least one remotely situated apparatus. Goodman, Abstract; col. 3:50-
`
`64. Goodman’s PHN comprises a host computer which is in communication
`
`with one or more patient nodes over a communication link, which preferably
`
`includes a telephone and a modem. See Goodman, Fig. 1; col. 3:50—64.
`
`60.
`
`Goodman
`
`inherently
`
`discloses
`
`a
`
`user
`
`interface
`
`in
`
`communication with the computer for entering, authoring, selecting, or some
`
`combination thereof, a message, query, or response choices. See, e.g.,
`
`Goodman, col. 8:37-51. Goodman teaches that an algorithm is generated
`
`based on a treatment plan and messages are displayed to the patient based at
`
`
`
`least in part on the treatment plan. Goodman, col. 8:37—51; col. 2:54-65.
`
`Goodman further provides that “query-type” messages,
`
`test results, and
`
`reminders (about, for example, a scheduled visit or to schedule a visit) may
`
`be provided based on the algorithm. Goodman, col. 5:5—8; col. 5:13-24; col.
`
`5:30-42; col. 8:45-61.
`
`61.
`
`One of ordinary skill in the art at the time of the invention of
`
`the “192 patent would recognize that the teachings of Goodman and Wright
`
`Jr. would be readily combined, necessarily resulting in, a data merge
`
`program configured to generate a customized script program by customizing
`
`a generic script program. Goodman describes a patient management
`
`program that develops algorithms based on treatment parameters for
`
`different health conditions. Goodman, col. 10:29—34, col. 2254-325. While
`
`these algorithms are inherently generic across patients with the same disease,
`
`Goodman provides for customizing each generic algorithm “based on a
`
`treatment plan or guidelines for a specific patient, which plan is provided by
`
`the primary provider 4.” Goodman, col
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