DETAILED ACTION
Acknowledgements
This office action is in response to the claims filed December 11, 2025.
Claims 1-20 are pending.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment(s)
Claims 1-20 are pending.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected to under 35 U.S.C 101 as not being directed to eligible subject matter based on the grounds set out in detail below:
Independent Claims 1, 7, and 15:
Eligibility Step 1 (does the subject matter fall within a statutory category?):
Independent claim 1 falls within the statutory category of machine.
Independent claims 7 and 15 falls within the statutory category of method.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Independent claims 1, 7, and 15 claimed invention is directed to an abstract idea without significantly more.
The claim elements which set forth the abstract idea in the independent claim 1:
a patient;
access, based on a usage scenario, a data structure comprising an algorithm for health event detection in patient data of the patient,
wherein association of the algorithm and the usage scenario in the data structure indicates that use of the algorithm for the usage scenario complies with one or more jurisdictional requirements;
in response to selection of the algorithm, generate information operative to perform an automatic configuration of the patient data to be interoperable with logic implementing the algorithm;
and apply the selected algorithm to the automatically configured data.
The claim elements which set forth the abstract idea in the independent claim 7:
responsive to receiving a service request, determining data indicative of one or more jurisdictional requirements corresponding to a patient location, wherein the service request comprises data identifying an algorithm for health event detection in patient data
in accordance with the service request, accessing structured data comprising an approved usage scenario for the algorithm to determine whether the algorithm complies with the one or more jurisdictional requirements;
based on a determination that the algorithm complies with the one or more jurisdictional requirements, automatically configuring the patient data to be interoperable with the algorithm;
and generating health event detection results based on an application of the algorithm to the configured patient data.
The claim elements which set forth the abstract idea in the independent claim 15:
accessing structured data comprising a usage scenario for an algorithm for health event detection in patient data
, wherein association of the algorithm and the usage scenario in the structured data indicates that the usage scenario satisfies with one or more jurisdictional requirements;
responsive to receiving the patient data, generating information operative to perform an automatic configuration of the patient data to be interoperable for logic implementing the algorithm;
and applying the algorithm to the automatically configured data.
The abstract idea is “certain methods of organizing human activity” by following rules and instructions to determine a health event in patient data (see MPEP § 2106.04(a)(2))
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For Independent claims 1, 7, and 15 judicial exception is not integrated into a practical application.
Independent claim 1 recites any the additional claim elements below:
A medical system comprising: communication circuitry communicatively coupled to one or more devices comprising at least one of a medical device or another device
processing circuitry
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The additional elements, (a) and (b), are recited as executing the abstract idea and is merely recited as a general computer elements as “apply-it” or an equivalent to gather and analyze data (see instant spec. [0224]-[0227])
Independent claim 7 and 15 do not recite additional elements not already recited in independent claim 1 thus treated as purely the abstract idea.
Accordingly, independent claims 1, 7, and 15 as a whole do not integrate the recited abstract idea into a practical application (MPEP 2106.05(f) and 2106.04(d)(1).
Eligibility Step 2B (Does the claim amount to significantly more?): The independent claims do does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the computer element as analyzed above in step 2A prong 2, is merely applying the abstract idea and therefore, does not amount to significantly more. The claim is patent ineligible.
Dependent Claims 2-6, 8-14, and 16-20
Eligibility Step 1 (does the subject matter fall within a statutory category?):
The dependent claims 2-6 fall within the statutory category of machine.
The dependent claims 8-14 and 16-20 fall within the statutory category of method.
Eligibility Step 2A-1 (does the claim recite an abstract idea, law of nature, or natural phenomenon?): Dependent claims 2-6, 8-14, and 16-20 claimed invention is directed to an abstract idea without significantly more. The claims continue to limit the independent claims 1, 7, and 15 abstract idea by (1) further limiting the meeting or not meeting of jurisdictional requirements, (2) further limiting the usage scenario, (3) further comparisons of algorithms, and (4) further limiting the generation of information. Therefore, the dependent claims inherit the same abstract idea of “certain methods of organizing human activity” by following rules and instructions to determine a health event in patient data (see MPEP § 2106.04(a)(2))
Eligibility Step 2A-2 (does the claim recite additional elements that integrate the judicial exception into a practical application?): For claims 2-6, 8-14, and 16-20 this judicial exception is not integrated into a practical application.
The dependent claims recite additional elements not already recited in the independent claims below:
an input device
an output device
a database system
at least one of an implantable medical device, a wearable medical device, a pacemaker/defibrillator, or a ventricular assist device (VAD)
memory
client application
Examiner takes the applicable considerations stated in MPEP 2106.04 (d) and analyzes them below in light of the instant applications disclosure and claim elements as a whole.
The additional elements, (a), (b), (c), (e), and (f) are recited as general computer elements as “apply-it” or an equivalent to gather, analyze, and output data
The additional elements, (d) is recited as generally linking the abstract idea to environment of on body medical devices
Accordingly, the dependent claims as a whole do not integrate the recited abstract idea into a practical application (MPEP 2106.05(f) and 2106.04(d)(1).
Eligibility Step 2B (Does the claim amount to significantly more?): The dependent claims do not include additional elements that amount to significantly more for the same reasons given in Prong 2. The claims are patent ineligible.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haller et. al (hereinafter Haller) (US20020082665A1)
As per claim 1, Haller teaches:
A medical system comprising: communication circuitry communicatively coupled to one or more devices comprising at least one of a medical device or another device of a patient; and processing circuitry configured to: ([0024] discloses, “Various embodiments of the present invention have certain features, including one or more of the following: (a) a communication module, Separate from, connectable to, or integral with a mobile telephone, the module being capable of communicating with an IMD and the mobile telephone; (b) a communication module capable of communicating with an IMD and a mobile telephone comprising a micro processor, a controller or other CPU, computer readable memory operable connected to the microprocessor, controller or CPU, and at least one RF or other suitable type of communications circuit for transmitting information to and receiving information from the IMD; (c) a communication module capable of communicating with an IMD and a mobile telephone comprising a data output port, cable and connector for connection to a mobile telephone data input port; (d) a communication module capable of communicating with an IMD and a mobile telephone comprising computer readable Software for initiating and maintaining communications with a mobile telephone using Standardized handshake protocols; (e) a communication module capable of communicating with an IMD and a mobile telephone comprising at least one of: a telemetry Signal Strength indicator, a telemetry Session Success indicator, a computer readable medium (such as volatile or non-volatile RAM, …[…]…”
access, based on a usage scenario, a data structure comprising an algorithm for health event detection in patient data generated by at least one of the medical device or the other device of the patient, wherein association of the algorithm and the usage scenario in the data structure indicates that use of the algorithm for the usage scenario complies with one or more jurisdictional requirements; ([0090] discloses, “FIG. 6C shows simple flow diagrams corresponding to one method of the present invention where IMD 10, communication module 100/mobile telephone or PDA 110 and remote system 130 communicate with another via communication system 120. IMD 10 may monitor various aspects of the patient's health, and Store same in memory as information or data. Upon IMD 10 detecting a threshold event (e.g., detection of arrhythmia or fibrillation in patient 5) or receiving instruction from patient 5 or remote System 130, IMD may upload stored information or data to remote system 130 via communication module 100, mobile tele phone 110 and communication system 130. IMD 10 may be interrogated directly by patient 5, or may be interrogated remotely by remote system 130 via communication module 100 and mobile telephone 110. The system of the present invention may also include provisions for determining the geographical location of the patient using mobile cell tele phone location data or by incorporating or otherwise operably connecting a Global Positioning System (GPS) module into communication module 100 or mobile telephone 110.” And see [0091] discloses, “In one embodiment of the present invention, IMD automatically contacts remote System 130 via communication module 100 and mobile telephone 110 in response to detecting a life-threatening or Serious condition in the patient's health. In response to receiving information concerning the detected condition from IMD 10, remote system 130 may be employed to automatically or under the Super vision of health care provider 135 or 136 provide an appropriate response, Such as the delivery of instructions to IMD 10 to deliver a specific therapy or alerting an emergency, ambulance or paramedic Service to proceed immediately to the location of patient 5. AS discussed above, the patient's Specific location may be provided by various means, Such as GPS or mobile telephone cell location identification information.” And see [0092] And see [0075] disclose, “Detection of atrial or ventricular tachyarrhythmias, as employed in the present invention, may correspond to tachyarrhythmia detection algorithms known in the art. For example, the presence of an atrial or Ventricular tachyarrhythmia may be confirmed by detecting a Sustained series of short R-R or P-P intervals of an average rate indicative of tachyarrhythmia or an unbroken Series of short R-R or P-P intervals.” And see [0198] discloses, “It will now become clear that an almost infinite number of combinations and permutations of the various Steps of the invoicing methods of the present invention may be conceived of and implemented in accordance with the teachings of the present invention. For example…[…]… Or IMD 10 may be re programmed with new Software or algorithms in response to review and analysis of information obtained remotely from IMD 10.” And see [0225] discloses, “For example, rule Set database 133 may contain information concerning whether a particular Software application may or may not be released and installed in an IMD 10 implanted within a patient 5 located in a particular country, or whether a Software application may or may not be installed due to a lack of approval by a governing body (Such as an govern mental agency or regulatory branch).” And see Fig. 12A and Fig. 12B, 148)
in response to selection of the algorithm, generate information operative to perform an automatic configuration of the patient data to be interoperable with logic implementing the algorithm; (see Fig. 12B steps 148-156, and see [0227] discloses, “In a preferred embodiment of the present invention, and regardless of the purpose for which communication module 100 and/or IMD 10 is connected with or interrogated by remote system 130, remote system 130 and/or data resource System 112 may be configured to automatically review the various hardware configurations and Software applications contained in communication module 100 and/or IMD 10. Updated software applications may therefore be installed automatically, if available and approved for installation in a particular communication module 100 and/or IMD 10. In some cases, such software installation may be a byte level update to Software already residing in the communication module 100 and/or IMD 10.”)
and apply the selected algorithm to the automatically configured data. ([0235] discloses, “If, on the other hand, the analysis reveals that a problem exists in respect of any one or more of IMD 10, communication module 100, mobile telephone or PDA 110, and/or patient 5, then remote system 130 and/or health care provider 136 determines an appropriate remedial response to the problem, Such as changing the operating parameters of IMD 10, communication module 100 and/or mobile tele phone or PDA 110, delivering a therapy to the patient (e.g., a pacing, cardioVerting or defibrillating therapy, or administration of a drug or other beneficial agent to patient 5), or instructing patient 5 by audio, Visual or other means to do Something Such as lie down, go to the hospital, call an ambulance, take a medication, or push a button.” And see [0236] discloses, “The remedial response or therapy determined in step 517 is next executed at step 519 by remote health care provider 136 or remote system 130 and relayed at step 521 via communication System 120 to communication module 100 and/or IMD 10 via mobile phone or PDA110. After the remedial response or therapy has been delivered, at step 525 communication module and/or mobile telephone 110 may Send a confirmatory message to remote System 130 and/or remote care giver 136 indicating that the remedial response or therapy has been delivered to patient 5 and/or IMD 10.”)
As per claim 2, Haller further teaches:
The medical system of claim 1, wherein the other device comprises an input device, an output device, and the processing circuitry. (see [0093] discloses, “FIG. 7 shows some basic components of communication module 100 according to one embodiment of the present invention. Communication module 100 preferably comprises microprocessor, CPU, micro-computer or con troller 104 for controlling the operation of module 100 and the exchange of data and information between IMD 10 and mobile telephone 110, telemetry module 101 for communicating with IMD 10, memory/storage module 105 for storing or recalling information or data in memory, a hard disk, or another computer readable medium Such as flash memory, ROM, RAM, EEPROM, and the like, power management module 106 for monitoring the State of charge and/or con trolling the discharge of a battery located in mobile tele phone 110 or in communication module 100, real time clock 109 for providing timing Signals to computing and controlling device 104, and display and/or user interface 108.” And see [0098] discloses, “As shown in FIG. 7, communication module 100 may include optional display and/or user interface 108 for conveying certain information to or from patient 5. Such information may include, without limitation, the current performance status of IMD 10, the patient’s current health Status, confirmation that an operation is being carried out or has been executed by module 100 or mobile telephone 110, indication that a health care provider is attempting to communicate or is communicating with patient 5, communication module 100 or IMD, indication that Successful telemetry communication between IMD 10 and module 100 is in progress, and the like. Display and/or user interface 108 may comprise, by way of example only, one or more LEDs, an LCD, a CRT, a plasma Screen, any other Suitable display device known in the mobile telephone, implantable medical device, computer, consumer appliance, consumer-product or other arts. Display and/or user interface 108 may also comprise, by way of example only, a keyboard, push buttons, a touch panel, a touch Screen, or any other Suitable user interface mechanism known in the mobile telephone, implantable medical device, computer, consumer appliance, consumer product or other arts.”)
As per claim 3, Haller further teaches:
The medical system of claim 1, wherein the processing circuitry is further configured to: based on a determination that the algorithm fails to comply with the one or more jurisdictional requirements, select, from a plurality of algorithms, a compatible algorithm for performing an application to the patient data in response to the algorithm failing to comply with the one or more jurisdictional requirements. ([0090] discloses, “FIG. 6C shows simple flow diagrams corresponding to one method of the present invention where IMD 10, communication module 100/mobile telephone or PDA 110 and remote system 130 communicate with another via communication system 120. IMD 10 may monitor various aspects of the patient's health, and Store same in memory as information or data. Upon IMD 10 detecting a threshold event (e.g., detection of arrhythmia or fibrillation in patient 5) or receiving instruction from patient 5 or remote System 130, IMD may upload stored information or data to remote system 130 via communication module 100, mobile tele phone 110 and communication system 130. IMD 10 may be interrogated directly by patient 5, or may be interrogated remotely by remote system 130 via communication module 100 and mobile telephone 110. The system of the present invention may also include provisions for determining the geographical location of the patient using mobile cell tele phone location data or by incorporating or otherwise operably connecting a Global Positioning System (GPS) module into communication module 100 or mobile telephone 110.” And see [0091] discloses, “In one embodiment of the present invention, IMD automatically contacts remote System 130 via communication module 100 and mobile telephone 110 in response to detecting a life-threatening or Serious condition in the patient's health. In response to receiving information concerning the detected condition from IMD 10, remote system 130 may be employed to automatically or under the Super vision of health care provider 135 or 136 provide an appropriate response, Such as the delivery of instructions to IMD 10 to deliver a specific therapy or alerting an emergency, ambulance or paramedic Service to proceed immediately to the location of patient 5. AS discussed above, the patient's Specific location may be provided by various means, Such as GPS or mobile telephone cell location identification information.” And see [0092] And see [0075] disclose, “Detection of atrial or ventricular tachyarrhythmias, as employed in the present invention, may correspond to tachyarrhythmia detection algorithms known in the art. For example, the presence of an atrial or Ventricular tachyarrhythmia may be confirmed by detecting a Sustained series of short R-R or P-P intervals of an average rate indicative of tachyarrhythmia or an unbroken Series of short R-R or P-P intervals.” And see [0198] discloses, “It will now become clear that an almost infinite number of combinations and permutations of the various Steps of the invoicing methods of the present invention may be conceived of and implemented in accordance with the teachings of the present invention. For example…[…]… Or IMD 10 may be re programmed with new Software or algorithms in response to review and analysis of information obtained remotely from IMD 10.” And see [0225] discloses, “For example, rule Set database 133 may contain information concerning whether a particular Software application may or may not be released and installed in an IMD 10 implanted within a patient 5 located in a particular country, or whether a Software application may or may not be installed due to a lack of approval by a governing body (Such as an govern mental agency or regulatory branch).” And see Fig. 12A and Fig. 12B, 148 / examiner notes one of ordinary skill would understand the prior art as cited to move forward with only those algorithms approved by governing body as explicitly stated)
As per claim 4, Haller further teaches:
The medical system of claim 1, wherein the processing circuitry is further configured to: determine non-compliance of the algorithm based on a comparison, using a database system, between the algorithm and the one or more jurisdictional requirements, wherein the database system arranges respective datasets for the plurality of algorithms, wherein a dataset corresponding to the algorithm comprises approved usage scenario information for an application of the algorithm to the patient data, wherein the comparison results indicate a failure of the approved usage scenario information to satisfy the one or more jurisdictional requirements. ([0090] discloses, “FIG. 6C shows simple flow diagrams corresponding to one method of the present invention where IMD 10, communication module 100/mobile telephone or PDA 110 and remote system 130 communicate with another via communication system 120. IMD 10 may monitor various aspects of the patient's health, and Store same in memory as information or data. Upon IMD 10 detecting a threshold event (e.g., detection of arrhythmia or fibrillation in patient 5) or receiving instruction from patient 5 or remote System 130, IMD may upload stored information or data to remote system 130 via communication module 100, mobile tele phone 110 and communication system 130. IMD 10 may be interrogated directly by patient 5, or may be interrogated remotely by remote system 130 via communication module 100 and mobile telephone 110. The system of the present invention may also include provisions for determining the geographical location of the patient using mobile cell tele phone location data or by incorporating or otherwise operably connecting a Global Positioning System (GPS) module into communication module 100 or mobile telephone 110.” And see [0091] discloses, “In one embodiment of the present invention, IMD automatically contacts remote System 130 via communication module 100 and mobile telephone 110 in response to detecting a life-threatening or Serious condition in the patient's health. In response to receiving information concerning the detected condition from IMD 10, remote system 130 may be employed to automatically or under the Super vision of health care provider 135 or 136 provide an appropriate response, Such as the delivery of instructions to IMD 10 to deliver a specific therapy or alerting an emergency, ambulance or paramedic Service to proceed immediately to the location of patient 5. AS discussed above, the patient's Specific location may be provided by various means, Such as GPS or mobile telephone cell location identification information.” And see [0092] And see [0075] disclose, “Detection of atrial or ventricular tachyarrhythmias, as employed in the present invention, may correspond to tachyarrhythmia detection algorithms known in the art. For example, the presence of an atrial or Ventricular tachyarrhythmia may be confirmed by detecting a Sustained series of short R-R or P-P intervals of an average rate indicative of tachyarrhythmia or an unbroken Series of short R-R or P-P intervals.” And see [0198] discloses, “It will now become clear that an almost infinite number of combinations and permutations of the various Steps of the invoicing methods of the present invention may be conceived of and implemented in accordance with the teachings of the present invention. For example…[…]… Or IMD 10 may be re programmed with new Software or algorithms in response to review and analysis of information obtained remotely from IMD 10.” And see [0225] discloses, “For example, rule Set database 133 may contain information concerning whether a particular Software application may or may not be released and installed in an IMD 10 implanted within a patient 5 located in a particular country, or whether a Software application may or may not be installed due to a lack of approval by a governing body (Such as an govern mental agency or regulatory branch).” And see Fig. 12A and Fig. 12B, 148 / examiner notes one of ordinary skill would understand the prior art as cited to move forward with only those algorithms approved by governing body as explicitly stated)
As per claim 5, Haller further teaches:
The medical system of claim 1, wherein the processing circuitry is further configured to: identify the compatible algorithm from plurality of algorithms based on a comparison, using a database system, between the compatible algorithm and the one or more jurisdictional requirements, wherein the database system arranges respective datasets for the plurality of algorithms, wherein a dataset corresponding to the compatible algorithm comprises approved usage scenario information for an application to the patient data, wherein the comparison results indicate satisfaction by the approved usage scenario information of the one or more jurisdictional requirements. ([0090] discloses, “FIG. 6C shows simple flow diagrams corresponding to one method of the present invention where IMD 10, communication module 100/mobile telephone or PDA 110 and remote system 130 communicate with another via communication system 120. IMD 10 may monitor various aspects of the patient's health, and Store same in memory as information or data. Upon IMD 10 detecting a threshold event (e.g., detection of arrhythmia or fibrillation in patient 5) or receiving instruction from patient 5 or remote System 130, IMD may upload stored information or data to remote system 130 via communication module 100, mobile tele phone 110 and communication system 130. IMD 10 may be interrogated directly by patient 5, or may be interrogated remotely by remote system 130 via communication module 100 and mobile telephone 110. The system of the present invention may also include provisions for determining the geographical location of the patient using mobile cell tele phone location data or by incorporating or otherwise operably connecting a Global Positioning System (GPS) module into communication module 100 or mobile telephone 110.” And see [0091] discloses, “In one embodiment of the present invention, IMD automatically contacts remote System 130 via communication module 100 and mobile telephone 110 in response to detecting a life-threatening or Serious condition in the patient's health. In response to receiving information concerning the detected condition from IMD 10, remote system 130 may be employed to automatically or under the Super vision of health care provider 135 or 136 provide an appropriate response, Such as the delivery of instructions to IMD 10 to deliver a specific therapy or alerting an emergency, ambulance or paramedic Service to proceed immediately to the location of patient 5. AS discussed above, the patient's Specific location may be provided by various means, Such as GPS or mobile telephone cell location identification information.” And see [0092] And see [0075] disclose, “Detection of atrial or ventricular tachyarrhythmias, as employed in the present invention, may correspond to tachyarrhythmia detection algorithms known in the art. For example, the presence of an atrial or Ventricular tachyarrhythmia may be confirmed by detecting a Sustained series of short R-R or P-P intervals of an average rate indicative of tachyarrhythmia or an unbroken Series of short R-R or P-P intervals.” And see [0198] discloses, “It will now become clear that an almost infinite number of combinations and permutations of the various Steps of the invoicing methods of the present invention may be conceived of and implemented in accordance with the teachings of the present invention. For example…[…]… Or IMD 10 may be re programmed with new Software or algorithms in response to review and analysis of information obtained remotely from IMD 10.” And see [0225] discloses, “For example, rule Set database 133 may contain information concerning whether a particular Software application may or may not be released and installed in an IMD 10 implanted within a patient 5 located in a particular country, or whether a Software application may or may not be installed due to a lack of approval by a governing body (Such as an govern mental agency or regulatory branch).” And see Fig. 12A and Fig. 12B, 148 / examiner notes one of ordinary skill would understand the prior art as cited to move forward with only those algorithms approved by governing body as explicitly stated)
As per claim 6, Haller further teaches:
The medical system of claim 1, wherein the medical device is communicatively coupled to the other device, wherein the medical device comprises at least one of an implantable medical device, a wearable medical device, a pacemaker/defibrillator, or a ventricular assist device (VAD) that comprises one or more sensors and sensing circuitry. (see Fig. 12A and see 0.048 FIG. 1 is a simplified schematic view of one embodiment of implantable medical device (“IMD”) 10 of the present invention. IMD 10 shown in FIG. 1 is a pacemaker comprising at least one of pacing and Sensing leads 16 and 18 attached to hermetically sealed enclosure 14 and implanted near human or mammalian heart 8.”)
As per claim 7, Haller further teaches:
A method for operating processing circuitry of a medical system comprising: ([0024] discloses, “Various embodiments of the present invention have certain features, including one or more of the following: (a) a communication module, Separate from, connectable to, or integral with a mobile telephone, the module being capable of communicating with an IMD and the mobile telephone; (b) a communication module capable of communicating with an IMD and a mobile telephone comprising a micro processor, a controller or other CPU, computer readable memory operable connected to the microprocessor, controller or CPU, and at least one RF or other suitable type of communications circuit for transmitting information to and receiving information from the IMD; (c) a communication module capable of communicating with an IMD and a mobile telephone comprising a data output port, cable and connector for connection to a mobile telephone data input port; (d) a communication module capable of communicating with an IMD and a mobile telephone comprising computer readable Software for initiating and maintaining communications with a mobile telephone using Standardized handshake protocols; (e) a communication module capable of communicating with an IMD and a mobile telephone comprising at least one of: a telemetry Signal Strength indicator, a telemetry Session Success indicator, a computer readable medium (such as volatile or non-volatile RAM, …[…]…”)
responsive to receiving a service request for a medical device, determining data indicative of one or more jurisdictional requirements corresponding to a patient location, wherein the service request comprises data identifying an algorithm for health event detection in patient data generated by the medical device or another device; (see Fig. 6C and see [0090] discloses, “FIG. 6C shows simple flow diagrams corresponding to one method of the present invention where IMD 10, communication module 100/mobile telephone or PDA 110 and remote system 130 communicate with another via communication system 120. IMD 10 may monitor various aspects of the patient's health, and Store same in memory as information or data. Upon IMD 10 detecting a threshold event (e.g., detection of arrhythmia or fibrillation in patient 5) or receiving instruction from patient 5 or remote System 130, IMD may upload stored information or data to remote system 130 via communication module 100, mobile tele phone 110 and communication system 130. IMD 10 may be interrogated directly by patient 5, or may be interrogated remotely by remote system 130 via communication module 100 and mobile telephone 110. The system of the present invention may also include provisions for determining the geographical location of the patient using mobile cell tele phone location data or by incorporating or otherwise operably connecting a Global Positioning System (GPS) module into communication module 100 or mobile telephone 110.” And see [0225] discloses, “It is preferred that release software database 128 be a Software database which includes all current Software applications or programs developed and configured for various communication modules 100 and/or IMDS 10. It is also preferred that rule set database 133 be a database containing information and data related to Specific rules and regulations regarding various Software applications for com munication module 100 and/or IMD 10. For example, rule Set database 133 may contain information concerning whether a particular Software application may or may not be released and installed in an IMD 10 implanted within a patient 5 located in a particular country, or whether a Software application may or may not be installed due to a lack of approval by a governing body (Such as an govern mental agency or regulatory branch). Rule Set database 133 may also contain information concerning whether the manu acturer, owner, licensee or licensor of a Software application has approved installation of the Software application into communication module 100 and/or IMD 10.”)
in accordance with the service request, accessing structured data comprising an approved usage scenario for the algorithm to determine whether the algorithm complies with the one or more jurisdictional requirements; ; ([0090] discloses, “FIG. 6C shows simple flow diagrams corresponding to one method of the present invention where IMD 10, communication module 100/mobile telephone or PDA 110 and remote system 130 communicate with another via communication system 120. IMD 10 may monitor various aspects of the patient's health, and Store same in memory as information or data. Upon IMD 10 detecting a threshold event (e.g., detection of arrhythmia or fibrillation in patient 5) or receiving instruction from patient 5 or remote System 130, IMD may upload stored information or data to remote system 130 via communication module 100, mobile tele phone 110 and communication system 130. IMD 10 may be interrogated directly by patient 5, or may be interrogated remotely by remote system 130 via communication module 100 and mobile telephone 110. The system of the present invention may also include provisions for determining the geographical location of the patient using mobile cell tele phone location data or by incorporating or otherwise operably connecting a Global Positioning System (GPS) module into communication module 100 or mobile telephone 110.” And see [0091] discloses, “In one embodiment of the present invention, IMD automatically contacts remote System 130 via communication module 100 and mobile telephone 110 in response to detecting a life-threatening or Serious condition in the patient's health. In response to receiving information concerning the detected condition from IMD 10, remote system 130 may be employed to automatically or under the Super vision of health care provider 135 or 136 provide an appropriate response, Such as the delivery of instructions to IMD 10 to deliver a specific therapy or alerting an emergency, ambulance or paramedic Service to proceed immediately to the location of patient 5. AS discussed above, the patient's Specific location may be provided by various means, Such as GPS or mobile telephone cell location identification information.” And see [0092] And see [0075] disclose, “Detection of atrial or ventricular tachyarrhythmias, as employed in the present invention, may correspond to tachyarrhythmia detection algorithms known in the art. For example, the presence of an atrial or Ventricular tachyarrhythmia may be confirmed by detecting a Sustained series of short R-R or P-P intervals of an average rate indicative of tachyarrhythmia or an unbroken Series of short R-R or P-P intervals.” And see [0198] discloses, “It will now become clear that an almost infinite number of combinations and permutations of the various Steps of the invoicing methods of the present invention may be conceived of and implemented in accordance with the teachings of the present invention. For example…[…]… Or IMD 10 may be re programmed with new Software or algorithms in response to review and analysis of information obtained remotely from IMD 10.” And see [0225] discloses, “For example, rule Set database 133 may contain information concerning whether a particular Software application may or may not be released and installed in an IMD 10 implanted within a patient 5 located in a particular country, or whether a Software application may or may not be installed due to a lack of approval by a governing body (Such as an govern mental agency or regulatory branch).” And see Fig. 12A and Fig. 12B, 148)
based on a determination that the algorithm complies with the one or more jurisdictional requirements, automatically configuring the patient data to be interoperable with the algorithm; (see Fig. 12B steps 148-156, and see [0227] discloses, “In a preferred embodiment of the present invention, and regardless of the purpose for which communication module 100 and/or IMD 10 is connected with or interrogated by remote system 130, remote system 130 and/or data resource System 112 may be configured to automatically review the various hardware configurations and Software applications contained in communication module 100 and/or IMD 10. Updated software applications may therefore be installed automatically, if available and approved for installation in a particular communication module 100 and/or IMD 10. In some cases, such software installation may be a byte level update to Software already residing in the communication module 100 and/or IMD 10.”)
and generating health event detection results based on an application of the algorithm to the configured patient data. ([0235] discloses, “If, on the other hand, the analysis reveals that a problem exists in respect of any one or more of IMD 10, communication module 100, mobile telephone or PDA 110, and/or patient 5, then remote system 130 and/or health care provider 136 determines an appropriate remedial response to the problem, Such as changing the operating parameters of IMD 10, communication module 100 and/or mobile tele phone or PDA 110, delivering a therapy to the patient (e.g., a pacing, cardioVerting or defibrillating therapy, or administration of a drug or other beneficial agent to patient 5), or instructing patient 5 by audio, Visual or other means to do Something Such as lie down, go to the hospital, call an ambulance, take a medication, or push a button.” And see [0236] discloses, “The remedial response or therapy determined in step 517 is next executed at step 519 by remote health care provider 136 or remote system 130 and relayed at step 521 via communication System 120 to communication module 100 and/or IMD 10 via mobile phone or PDA110. After the remedial response or therapy has been delivered, at step 525 communication module and/or mobile telephone 110 may Send a confirmatory message to remote System 130 and/or remote care giver 136 indicating that the remedial response or therapy has been delivered to patient 5 and/or IMD 10.”)
As per claims 8-10 they are method claims which repeat the same limitations of claims 3,4, and 5. Since the teachings of Haller disclose the underlying process steps that constitute the methods of claims 3, 4, 5, it is respectfully submitted that they teach the limitations for claims 8-10 As such, the limitations of claims 8-10 are rejected for the same reasons given above for claims 3-5.
As per claim 11, Haller further teaches:
The method of claim 7, further comprising: identifying the compatible algorithm from plurality of algorithms based on a comparison, using a database system, between the compatible algorithm and the algorithm, wherein the database system arranges respective datasets for the plurality of algorithms, wherein a dataset corresponding to the compatible algorithm comprises a set of characteristics, wherein the comparison results indicate compatibility of the compatible algorithm. ([0090] discloses, “FIG. 6C shows simple flow diagrams corresponding to one method of the present invention where IMD 10, communication module 100/mobile telephone or PDA 110 and remote system 130 communicate with another via communication system 120. IMD 10 may monitor various aspects of the patient's health, and Store same in memory as information or data. Upon IMD 10 detecting a threshold event (e.g., detection of arrhythmia or fibrillation in patient 5) or receiving instruction from patient 5 or remote System 130, IMD may upload stored information or data to remote system 130 via communication module 100, mobile tele phone 110 and communication system 130. IMD 10 may be interrogated directly by patient 5, or may be interrogated remotely by remote system 130 via communication module 100 and mobile telephone 110. The system of the present invention may also include provisions for determining the geographical location of the patient using mobile cell tele phone location data or by incorporating or otherwise operably connecting a Global Positioning System (GPS) module into communication module 100 or mobile telephone 110.” And see [0091] discloses, “In one embodiment of the present invention, IMD automatically contacts remote System 130 via communication module 100 and mobile telephone 110 in response to detecting a life-threatening or Serious condition in the patient's health. In response to receiving information concerning the detected condition from IMD 10, remote system 130 may be employed to automatically or under the Super vision of health care provider 135 or 136 provide an appropriate response, Such as the delivery of instructions to IMD 10 to deliver a specific therapy or alerting an emergency, ambulance or paramedic Service to proceed immediately to the location of patient 5. AS discussed above, the patient's Specific location may be provided by various means, Such as GPS or mobile telephone cell location identification information.” And see [0092] And see [0075] disclose, “Detection of atrial or ventricular tachyarrhythmias, as employed in the present invention, may correspond to tachyarrhythmia detection algorithms known in the art. For example, the presence of an atrial or Ventricular tachyarrhythmia may be confirmed by detecting a Sustained series of short R-R or P-P intervals of an average rate indicative of tachyarrhythmia or an unbroken Series of short R-R or P-P intervals.” And see [0198] discloses, “It will now become clear that an almost infinite number of combinations and permutations of the various Steps of the invoicing methods of the present invention may be conceived of and implemented in accordance with the teachings of the present invention. For example…[…]… Or IMD 10 may be re programmed with new Software or algorithms in response to review and analysis of information obtained remotely from IMD 10.” And see [0225] discloses, “For example, rule Set database 133 may contain information concerning whether a particular Software application may or may not be released and installed in an IMD 10 implanted within a patient 5 located in a particular country, or whether a Software application may or may not be installed due to a lack of approval by a governing body (Such as an govern mental agency or regulatory branch).” And see Fig. 12A and Fig. 12B, 148 / examiner notes one of ordinary skill would understand the prior art as cited to move forward with only those algorithms approved by governing body as explicitly stated)
As per claim 12, Haller further teaches:
The method of any of claim 7, wherein accessing the structured data comprises: generating information operative to implement the compatible algorithm in at least one of the medical device or the other device, wherein the generated information indicates at least one modification to device logic in memory of the at least one of the medical device or the other device, wherein the modified device logic is executed to apply the algorithm to the patient data. (see Fig. 12B steps 148-156, and see [0227] discloses, “In a preferred embodiment of the present invention, and regardless of the purpose for which communication module 100 and/or IMD 10 is connected with or interrogated by remote system 130, remote system 130 and/or data resource System 112 may be configured to automatically review the various hardware configurations and Software applications contained in communication module 100 and/or IMD 10. Updated software applications may therefore be installed automatically, if available and approved for installation in a particular communication module 100 and/or IMD 10. In some cases, such software installation may be a byte level update to Software already residing in the communication module 100 and/or IMD 10.”)
As per claim 13, Haller further teaches:
The method of claim 7, wherein accessing the structured data comprises: accessing the structured data comprising an approved usage scenario for the algorithm for health event detection in the patient data generated by the at least one of the medical device of the patient or another device of the patient; ([0090] discloses, “FIG. 6C shows simple flow diagrams corresponding to one method of the present invention where IMD 10, communication module 100/mobile telephone or PDA 110 and remote system 130 communicate with another via communication system 120. IMD 10 may monitor various aspects of the patient's health, and Store same in memory as information or data. Upon IMD 10 detecting a threshold event (e.g., detection of arrhythmia or fibrillation in patient 5) or receiving instruction from patient 5 or remote System 130, IMD may upload stored information or data to remote system 130 via communication module 100, mobile tele phone 110 and communication system 130. IMD 10 may be interrogated directly by patient 5, or may be interrogated remotely by remote system 130 via communication module 100 and mobile telephone 110. The system of the present invention may also include provisions for determining the geographical location of the patient using mobile cell tele phone location data or by incorporating or otherwise operably connecting a Global Positioning System (GPS) module into communication module 100 or mobile telephone 110.” And see [0091] discloses, “In one embodiment of the present invention, IMD automatically contacts remote System 130 via communication module 100 and mobile telephone 110 in response to detecting a life-threatening or Serious condition in the patient's health. In response to receiving information concerning the detected condition from IMD 10, remote system 130 may be employed to automatically or under the Super vision of health care provider 135 or 136 provide an appropriate response, Such as the delivery of instructions to IMD 10 to deliver a specific therapy or alerting an emergency, ambulance or paramedic Service to proceed immediately to the location of patient 5. AS discussed above, the patient's Specific location may be provided by various means, Such as GPS or mobile telephone cell location identification information.” And see [0092] And see [0075] disclose, “Detection of atrial or ventricular tachyarrhythmias, as employed in the present invention, may correspond to tachyarrhythmia detection algorithms known in the art. For example, the presence of an atrial or Ventricular tachyarrhythmia may be confirmed by detecting a Sustained series of short R-R or P-P intervals of an average rate indicative of tachyarrhythmia or an unbroken Series of short R-R or P-P intervals.” And see [0198] discloses, “It will now become clear that an almost infinite number of combinations and permutations of the various Steps of the invoicing methods of the present invention may be conceived of and implemented in accordance with the teachings of the present invention. For example…[…]… Or IMD 10 may be re programmed with new Software or algorithms in response to review and analysis of information obtained remotely from IMD 10.” And see [0225] discloses, “For example, rule Set database 133 may contain information concerning whether a particular Software application may or may not be released and installed in an IMD 10 implanted within a patient 5 located in a particular country, or whether a Software application may or may not be installed due to a lack of approval by a governing body (Such as an govern mental agency or regulatory branch).” And see Fig. 12A and Fig. 12B, 148) in response to selection of the algorithm, generating information operative to perform an automatic configuration of the patient data to be input for logic implementing the algorithm; (see Fig. 12B steps 148-156, and see [0227] discloses, “In a preferred embodiment of the present invention, and regardless of the purpose for which communication module 100 and/or IMD 10 is connected with or interrogated by remote system 130, remote system 130 and/or data resource System 112 may be configured to automatically review the various hardware configurations and Software applications contained in communication module 100 and/or IMD 10. Updated software applications may therefore be installed automatically, if available and approved for installation in a particular communication module 100 and/or IMD 10. In some cases, such software installation may be a byte level update to Software already residing in the communication module 100 and/or IMD 10.”)
and executing the logic for applying the selected algorithm to the automatically configured data. ([0235] discloses, “If, on the other hand, the analysis reveals that a problem exists in respect of any one or more of IMD 10, communication module 100, mobile telephone or PDA 110, and/or patient 5, then remote system 130 and/or health care provider 136 determines an appropriate remedial response to the problem, Such as changing the operating parameters of IMD 10, communication module 100 and/or mobile tele phone or PDA 110, delivering a therapy to the patient (e.g., a pacing, cardioVerting or defibrillating therapy, or administration of a drug or other beneficial agent to patient 5), or instructing patient 5 by audio, Visual or other means to do Something Such as lie down, go to the hospital, call an ambulance, take a medication, or push a button.” And see [0236] discloses, “The remedial response or therapy determined in step 517 is next executed at step 519 by remote health care provider 136 or remote system 130 and relayed at step 521 via communication System 120 to communication module 100 and/or IMD 10 via mobile phone or PDA110. After the remedial response or therapy has been delivered, at step 525 communication module and/or mobile telephone 110 may Send a confirmatory message to remote System 130 and/or remote care giver 136 indicating that the remedial response or therapy has been delivered to patient 5 and/or IMD 10.”)
As per claim 14, Haller further teaches:
The method of claim 7, wherein accessing the structured data comprises: accessing structured data comprising a usage scenario for an algorithm for health event detection in patient data generated by at least one of a medical device of the patient or another device of the patient, wherein association of the algorithm and the usage scenario in the structured data indicates that the usage scenario satisfies with one or more jurisdictional requirements; ([0090] discloses, “FIG. 6C shows simple flow diagrams corresponding to one method of the present invention where IMD 10, communication module 100/mobile telephone or PDA 110 and remote system 130 communicate with another via communication system 120. IMD 10 may monitor various aspects of the patient's health, and Store same in memory as information or data. Upon IMD 10 detecting a threshold event (e.g., detection of arrhythmia or fibrillation in patient 5) or receiving instruction from patient 5 or remote System 130, IMD may upload stored information or data to remote system 130 via communication module 100, mobile tele phone 110 and communication system 130. IMD 10 may be interrogated directly by patient 5, or may be interrogated remotely by remote system 130 via communication module 100 and mobile telephone 110. The system of the present invention may also include provisions for determining the geographical location of the patient using mobile cell tele phone location data or by incorporating or otherwise operably connecting a Global Positioning System (GPS) module into communication module 100 or mobile telephone 110.” And see [0091] discloses, “In one embodiment of the present invention, IMD automatically contacts remote System 130 via communication module 100 and mobile telephone 110 in response to detecting a life-threatening or Serious condition in the patient's health. In response to receiving information concerning the detected condition from IMD 10, remote system 130 may be employed to automatically or under the Super vision of health care provider 135 or 136 provide an appropriate response, Such as the delivery of instructions to IMD 10 to deliver a specific therapy or alerting an emergency, ambulance or paramedic Service to proceed immediately to the location of patient 5. AS discussed above, the patient's Specific location may be provided by various means, Such as GPS or mobile telephone cell location identification information.” And see [0092] And see [0075] disclose, “Detection of atrial or ventricular tachyarrhythmias, as employed in the present invention, may correspond to tachyarrhythmia detection algorithms known in the art. For example, the presence of an atrial or Ventricular tachyarrhythmia may be confirmed by detecting a Sustained series of short R-R or P-P intervals of an average rate indicative of tachyarrhythmia or an unbroken Series of short R-R or P-P intervals.” And see [0198] discloses, “It will now become clear that an almost infinite number of combinations and permutations of the various Steps of the invoicing methods of the present invention may be conceived of and implemented in accordance with the teachings of the present invention. For example…[…]… Or IMD 10 may be re programmed with new Software or algorithms in response to review and analysis of information obtained remotely from IMD 10.” And see [0225] discloses, “For example, rule Set database 133 may contain information concerning whether a particular Software application may or may not be released and installed in an IMD 10 implanted within a patient 5 located in a particular country, or whether a Software application may or may not be installed due to a lack of approval by a governing body (Such as an govern mental agency or regulatory branch).” And see Fig. 12A and Fig. 12B, 148)
in response to selection of the algorithm, generating information operative to perform an automatic configuration of the patient data to be interoperable for logic implementing the algorithm; (see Fig. 12B steps 148-156, and see [0227] discloses, “In a preferred embodiment of the present invention, and regardless of the purpose for which communication module 100 and/or IMD 10 is connected with or interrogated by remote system 130, remote system 130 and/or data resource System 112 may be configured to automatically review the various hardware configurations and Software applications contained in communication module 100 and/or IMD 10. Updated software applications may therefore be installed automatically, if available and approved for installation in a particular communication module 100 and/or IMD 10. In some cases, such software installation may be a byte level update to Software already residing in the communication module 100 and/or IMD 10.”)
and executing the logic for applying the selected algorithm to the automatically configured data. ([0235] discloses, “If, on the other hand, the analysis reveals that a problem exists in respect of any one or more of IMD 10, communication module 100, mobile telephone or PDA 110, and/or patient 5, then remote system 130 and/or health care provider 136 determines an appropriate remedial response to the problem, Such as changing the operating parameters of IMD 10, communication module 100 and/or mobile tele phone or PDA 110, delivering a therapy to the patient (e.g., a pacing, cardioVerting or defibrillating therapy, or administration of a drug or other beneficial agent to patient 5), or instructing patient 5 by audio, Visual or other means to do Something Such as lie down, go to the hospital, call an ambulance, take a medication, or push a button.” And see [0236] discloses, “The remedial response or therapy determined in step 517 is next executed at step 519 by remote health care provider 136 or remote system 130 and relayed at step 521 via communication System 120 to communication module 100 and/or IMD 10 via mobile phone or PDA110. After the remedial response or therapy has been delivered, at step 525 communication module and/or mobile telephone 110 may Send a confirmatory message to remote System 130 and/or remote care giver 136 indicating that the remedial response or therapy has been delivered to patient 5 and/or IMD 10.”)
As per claim 15, Haller further teaches:
A method for operating processing circuitry of a medical system comprising: ([0024] discloses, “Various embodiments of the present invention have certain features, including one or more of the following: (a) a communication module, Separate from, connectable to, or integral with a mobile telephone, the module being capable of communicating with an IMD and the mobile telephone; (b) a communication module capable of communicating with an IMD and a mobile telephone comprising a micro processor, a controller or other CPU, computer readable memory operable connected to the microprocessor, controller or CPU, and at least one RF or other suitable type of communications circuit for transmitting information to and receiving information from the IMD; (c) a communication module capable of communicating with an IMD and a mobile telephone comprising a data output port, cable and connector for connection to a mobile telephone data input port; (d) a communication module capable of communicating with an IMD and a mobile telephone comprising computer readable Software for initiating and maintaining communications with a mobile telephone using Standardized handshake protocols; (e) a communication module capable of communicating with an IMD and a mobile telephone comprising at least one of: a telemetry Signal Strength indicator, a telemetry Session Success indicator, a computer readable medium (such as volatile or non-volatile RAM, …[…]…”)
accessing structured data comprising a usage scenario for an algorithm for health event detection in patient data generated by at least one of a medical device or another device, wherein association of the algorithm and the usage scenario in the structured data indicates that the usage scenario satisfies with one or more jurisdictional requirements; ([0090] discloses, “FIG. 6C shows simple flow diagrams corresponding to one method of the present invention where IMD 10, communication module 100/mobile telephone or PDA 110 and remote system 130 communicate with another via communication system 120. IMD 10 may monitor various aspects of the patient's health, and Store same in memory as information or data. Upon IMD 10 detecting a threshold event (e.g., detection of arrhythmia or fibrillation in patient 5) or receiving instruction from patient 5 or remote System 130, IMD may upload stored information or data to remote system 130 via communication module 100, mobile tele phone 110 and communication system 130. IMD 10 may be interrogated directly by patient 5, or may be interrogated remotely by remote system 130 via communication module 100 and mobile telephone 110. The system of the present invention may also include provisions for determining the geographical location of the patient using mobile cell tele phone location data or by incorporating or otherwise operably connecting a Global Positioning System (GPS) module into communication module 100 or mobile telephone 110.” And see [0091] discloses, “In one embodiment of the present invention, IMD automatically contacts remote System 130 via communication module 100 and mobile telephone 110 in response to detecting a life-threatening or Serious condition in the patient's health. In response to receiving information concerning the detected condition from IMD 10, remote system 130 may be employed to automatically or under the Super vision of health care provider 135 or 136 provide an appropriate response, Such as the delivery of instructions to IMD 10 to deliver a specific therapy or alerting an emergency, ambulance or paramedic Service to proceed immediately to the location of patient 5. AS discussed above, the patient's Specific location may be provided by various means, Such as GPS or mobile telephone cell location identification information.” And see [0092] And see [0075] disclose, “Detection of atrial or ventricular tachyarrhythmias, as employed in the present invention, may correspond to tachyarrhythmia detection algorithms known in the art. For example, the presence of an atrial or Ventricular tachyarrhythmia may be confirmed by detecting a Sustained series of short R-R or P-P intervals of an average rate indicative of tachyarrhythmia or an unbroken Series of short R-R or P-P intervals.” And see [0198] discloses, “It will now become clear that an almost infinite number of combinations and permutations of the various Steps of the invoicing methods of the present invention may be conceived of and implemented in accordance with the teachings of the present invention. For example…[…]… Or IMD 10 may be re programmed with new Software or algorithms in response to review and analysis of information obtained remotely from IMD 10.” And see [0225] discloses, “For example, rule Set database 133 may contain information concerning whether a particular Software application may or may not be released and installed in an IMD 10 implanted within a patient 5 located in a particular country, or whether a Software application may or may not be installed due to a lack of approval by a governing body (Such as an govern mental agency or regulatory branch).” And see Fig. 12A and Fig. 12B, 148)
responsive to receiving the patient data, generating information operative to perform an automatic configuration of the patient data to be interoperable for logic implementing the algorithm; (see Fig. 12B steps 148-156, and see [0227] discloses, “In a preferred embodiment of the present invention, and regardless of the purpose for which communication module 100 and/or IMD 10 is connected with or interrogated by remote system 130, remote system 130 and/or data resource System 112 may be configured to automatically review the various hardware configurations and Software applications contained in communication module 100 and/or IMD 10. Updated software applications may therefore be installed automatically, if available and approved for installation in a particular communication module 100 and/or IMD 10. In some cases, such software installation may be a byte level update to Software already residing in the communication module 100 and/or IMD 10.”)
and applying the algorithm to the automatically configured data. ([0235] discloses, “If, on the other hand, the analysis reveals that a problem exists in respect of any one or more of IMD 10, communication module 100, mobile telephone or PDA 110, and/or patient 5, then remote system 130 and/or health care provider 136 determines an appropriate remedial response to the problem, Such as changing the operating parameters of IMD 10, communication module 100 and/or mobile tele phone or PDA 110, delivering a therapy to the patient (e.g., a pacing, cardioVerting or defibrillating therapy, or administration of a drug or other beneficial agent to patient 5), or instructing patient 5 by audio, Visual or other means to do Something Such as lie down, go to the hospital, call an ambulance, take a medication, or push a button.” And see [0236] discloses, “The remedial response or therapy determined in step 517 is next executed at step 519 by remote health care provider 136 or remote system 130 and relayed at step 521 via communication System 120 to communication module 100 and/or IMD 10 via mobile phone or PDA110. After the remedial response or therapy has been delivered, at step 525 communication module and/or mobile telephone 110 may Send a confirmatory message to remote System 130 and/or remote care giver 136 indicating that the remedial response or therapy has been delivered to patient 5 and/or IMD 10.”)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 16-20 are rejected to under 35 U.S.C. 103 as being unpatentable over Haller et. al (hereinafter Haller) (US20020082665A1) in view of Miller et. al (hereinafter Miller) (US11461691B2)
As per claim 16, Haller does not teach:
The method of claim 15, wherein a memory of the medical system comprises data configured to define the algorithm as a dataset comprising characteristics information and a unique identity amongst a plurality of algorithms.
However, Miller does teach:
The method of claim 15, wherein a memory of the medical system comprises data configured to define the algorithm as a dataset comprising characteristics information and a unique identity amongst a plurality of algorithms. (Col. 4 lines 23-30 discloses, a pool of algorithms with characteristics such as information and unique identifier)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Haller’s teachings algorithm updates meeting certain criteria as previously cited with Miller’s teachings of defining the algorithm comprising certain characteristic information and unique identity amongst a pool of algorithms, as previously cited, the motivation being Haller’s is already concerned with ensuring software which houses the algorithms integrity by checking software status and parameters and pushing new versions of an algorithm (see para. [0224]), thus combining with Miller would be an improvement in version control, proper attribution, and accurate monitoring for patient events and would not render Haller inoperable as the hardware and software in Haller would be predictable to combine with various pools of chosen defined algorithms in Miller.
As per claim 17, Haller does not teach:
The method of claim 16, wherein generating the information comprises: determining updated parameter data that matches the characteristics information for the algorithm, the characteristics information comprising an input parameter or an output parameter.
However, Miller does teach:
The method of claim 16, wherein generating the information comprises: determining updated parameter data that matches the characteristics information for the algorithm, the characteristics information comprising an input parameter or an output parameter. (Col. 10 lines 1-40 and see Col. 14 lines 1-26 discloses input and output parameter data that matches characteristics information for the algorithm and can be updated as required)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Haller’s teachings with Miller’s teachings for the same reasons given for claim 16.
As per claim 18, Haller does not teach:
The method of claim 16, wherein generating the information comprises: identifying parameter data of a logic component of the medical device or other device, wherein the parameter data defines a configuration of input data for the algorithm; and modifying the parameter data based on the characteristics information for the algorithm.
However, Miller does teach:
The method of claim 16, wherein generating the information comprises: identifying parameter data of a logic component of the medical device or other device, wherein the parameter data defines a configuration of input data for the algorithm; and modifying the parameter data based on the characteristics information for the algorithm. (Col. 10 lines 1-67 and see Col. 11 lines 1-21 and see Col. 12 lines 13-36 and see Col. 13 lines 3-26 and see Col. 14 lines 1-26 discloses input and output parameter data that matches characteristics information for the algorithm and can be updated as required for a hardware device where configurations of the input data are defined for the algorithm and modified data is based on the characteristics of the algorithm)
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Haller’s teachings with Miller’s teachings for the same reasons given for claim 16.
As per claim 19, Haller further teaches:
The method of claim 18, wherein generating the information comprises: generating instructions that a client application running on the other device executes to apply the at least one modification to the device logic. ([0027] discloses, “In yet another embodiment of the present invention, the critical components, embedded Systems of and Software in the communication module and/or the IMD may be remotely maintained, debugged and/or evaluated via the mobile telephone and/or PDA to ensure proper functionality and performance by down-linking Suitable Software or diagnostic routines or instructions originating at the remote computer, the remote health care provider, or the remote web-based expert data center, or by up-linking Software loaded into the communication module and/or IMD for comparison or evaluation by the remote computer, the remote health care provider, or the remote web-based expert data center. The operational and functional Software of the embedded systems in the IMD and/or the communication module may be remotely adjusted, upgraded or changed as required. At least Some Software changes may be implemented in the IMD by downlinking from the communication module to the IMD.” And see [0091] discloses, “In one embodiment of the present invention, IMD automatically contacts remote System 130 via communication module 100 and mobile telephone 110 in response to detecting a life-threatening or Serious condition in the patient's health. In response to receiving information concerning the detected condition from IMD 10, remote system 130 may be employed to automatically or under the Super vision of health care provider 135 or 136 provide an appropriate response, Such as the delivery of instructions to IMD 10 to deliver a specific therapy or alerting an emergency, ambulance or paramedic Service to proceed immediately to the location of patient 5. AS discussed above, the patient's Specific location may be provided by various means, Such as GPS or mobile telephone cell location identification information.”)
As per claim 20, Haller further teaches:
The method of claim 18, wherein the at least one of the medical device or the other device is configured with the logic implementing the algorithm and invokes the logic implementing the algorithm to monitor the patient data for patient activity indicative of health events. ([0090] discloses, “FIG. 6C shows simple flow diagrams corresponding to one method of the present invention where IMD 10, communication module 100/mobile telephone or PDA 110 and remote system 130 communicate with another via communication system 120. IMD 10 may monitor various aspects of the patient's health, and Store same in memory as information or data. Upon IMD 10 detecting a threshold event (e.g., detection of arrhythmia or fibrillation in patient 5) or receiving instruction from patient 5 or remote System 130, IMD may upload stored information or data to remote system 130 via communication module 100, mobile tele phone 110 and communication system 130. IMD 10 may be interrogated directly by patient 5, or may be interrogated remotely by remote system 130 via communication module 100 and mobile telephone 110. The system of the present invention may also include provisions for determining the geographical location of the patient using mobile cell tele phone location data or by incorporating or otherwise operably connecting a Global Positioning System (GPS) module into communication module 100 or mobile telephone 110.” And see [0198] discloses, “Or IMD 10 may be re programmed with new Software or algorithms in response to review and analysis of information obtained remotely from IMD 10.”)
Prior Art not cited but made of record
US11531904B2- Callcut et. al
The present disclosure relates to techniques for developing artificial intelligence algorithms by distributing analytics to multiple sources of privacy protected , harmonized data . Particularly , aspects are directed to a computer implemented method that includes receiving an algorithm and input data requirements associated with the algorithm , identifying data assets as being available from a data host based on the input data requirements , curating the data assets within a data storage structure that is within infrastructure of the data host , and integrating the algorithm into a secure capsule comput ing framework . The secure capsule computing framework serves the algorithm to the data assets within the data storage structure in a secure manner that preserves privacy of the data assets and the algorithm . The computer implemented method further includes running the data assets through the algorithm to obtain an inference.
Response to Arguments Regarding 35 U.S.C § 101 Rejections
Applicant’s arguments on pages 1-5 of remarks have been considered. Applicant argues the 35 U.S.C § 101 rejection should be withdrawn for the following reasons. The Office Action rejected claims 1-20 under 35 U.S.C. § 101 based on an assertion that these claims are directed to non-statutory subject matter.
Claim 1 recites: "in response to selection of the algorithm, generate information operative to perform an automatic configuration of the patient data to be interoperable with logic implementing the algorithm; and apply the selected algorithm to the automatically configured data."
The Office asserted the above-quoted features of claim 1 allegedly recite an abstract idea of "certain methods of organizing human activity."i The USPTO issued the 2024 Guidance Update on Patent Subject Matter Eligibility on July 17, 2024, that provided guidance on the "certain methods of organizing human activity."
For example, the 2024 Guidance update stated: "The USPTO's guidance on the "certain methods of organizing human activity" abstract idea grouping is found in MPEP 2106.04(a)(2), subsection II and describes concepts related to fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts, legal obligations, advertising, marketing or sales activities or behaviors, and business relations); and managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The term "certain" qualifies the "certain methods of organizing human activity" grouping, and as a 1 September 26, 2025, Office Action, pgs. 3-4. result, not all methods of organizing human activity are abstract ideas In addition, except in rare circumstances, this grouping should not be expanded beyond the activity within the enumerated sub-groupings of fundamental economic principles or practices, commercial or legal interactions, and managing personal behavior or relationships or interactions between people."2
The Office Action fails to provide any explanation how the features of "generate information operative to perform an automatic configuration of the patient data to be interoperable with logic implementing the algorithm" and "apply the selected algorithm to the automatically configured data" would fall under "fundamental economic principles or practices,""commercial or legal interactions," or "managing personal behavior or relationships or interactions between people." As indicated in the 2024 Guidance update, except in rare circumstances, this grouping should not be expanded beyond the activity within the enumerated sub-groupings of fundamental economic principles or practices, commercial or legal interactions, and managing personal behavior or relationships or interactions between people.
The Office has asserted that these features are alleged abstract ideas with no explanation of how they would fall within any of the categories of "certain methods of organizing human activity." As such, a prima facie case that the feature that the feature "generate information operative to perform an automatic configuration of the patient data to be interoperable with logic implementing the algorithm," recited in claim 1 has not been established.
As an example, paragraphs [0045-047] of the Specification state: "A device located within the local jurisdiction is permitted to use only validated algorithms to evaluate patient 4's data for indicia of a particular health event (e.g., a cardiac event). As another validation requirement, the local jurisdiction may set forth rules to legitimize the device for an application of the algorithm, for example, by ensuring that the device is appropriately configured prior to approval to use the algorithm. Some of these rules, for instance, may require the device include components that are interoperable with logic for the algorithm. Assuming the algorithm uses a machine learning model, the local jurisdiction may require a specific version of a known model be used when implementing the algorithm in the device. As described herein, the present disclosure codifies a usage scenario for IMD 10 and/or its patient data using a number of attributes of a dataset that describes how patient 4/user 8 intends to use a particular algorithm when analyzing the patient data. Example attributes identify a country or region (e.g., US or non-US country), a setting (e.g., clinical setting or public setting), an identity for the particular algorithm (e.g., a specific version of an algorithm for 2 2024 Guidance Update on Patent Subject Matter Eligibility, section III.A.1.B. detecting cardiac events), and/or the like. While the particular algorithm may have been validated for certain uses in IMD 10, that validation is conditioned upon one or more jurisdictional requirements. To effectuate the validation requirements set forth by the local jurisdiction, HMS 22 may run logic for simulating IMD 10 operation(s) in the cloud service devices. In a virtual embodiment of IMD 10, the logic may be a functional component of that embodiment. Accordingly, this logic component may define parameters associated with execution of an algorithm as described herein. Some example parameters that are defined in HMS 22 include input parameters including input features for a machine learning model. Some example parameters specify the machine learning model's components (e.g., a mathematical function or probability distribution). Some example parameters further define output parameters including (valid) output labels of the machine learning model. Modifying one or more of these parameters may cause a reconfiguration of patient datasets, resulting in reconfigured datasets that are compatible (e.g., as input to the algorithm). The logical component for virtualizing IVID 10 may also run the algorithm as a single logic component. In an alternative example, another program may be executed to run the algorithm as a separate logical component. The reconfiguration of the patient datasets allows interoperability between the separated logical components or between the logical component for the running algorithm and/or IMD 10 itself. Not only is the feature "generate information operative to perform an automatic configuration of the patient data to be interoperable with logic implementing the algorithm" not a certain method of organizing human activity, the feature does not recite any type of abstract idea.
Applicant respectfully submits that generating information operative to perform an automatic configuration of the patient data to be interoperable with logic implementing the algorithm, as a practical matter, necessitates the use of a computer.
Accordingly, Applicant respectfully submits that the feature "generate information operative to perform an automatic configuration of the patient data to be interoperable with logic implementing the algorithm," recited in claim 1 is not an abstract idea.
In a memorandum dated August 4, 2025 ("the Memo"), Deputy Commissioner Kim provides Examiners with further guidance on several topics related to subject matter eligibility analysis, particularly around Step 2A of the USPTO's subject matter eligibility analysis.
The Memo outlines some additional guidance for "Improvements consideration" and "'Apply it' consideration." Of relevance to this application, the Memo provides that, "Examiners are cautioned not to oversimplify claim limitations and expand the application of the 'apply it' consideration" and "Claims that are determined to improve computer capabilities or improve technology or a technical field support a finding that the claim integrates the judicial exception into a practical application or amounts to significantly more than the judicial exception itself." With respect to Step 2A Prong Two, the Memo states "When evaluating [the 'Improvements consideration' and 'Apply it'] considerations, examiners may consider the following: 1. Whether the claim recites only the idea of a solution or outcome, i.e., the claim fails to recite details of how a solution to a problem is accomplished, or the claim covers a particular solution to a problem or a particular way to achieve a desired outcome. 2. Whether the claim invokes computers or other machinery merely as a tool to perform an existing process, or whether the claim purports to improve computer capabilities or to improve an existing technology. 3. The particularity or generality of the application of the judicial exception."
As shown above with respect to claim 1: Claim 1 clearly covers a particular solution to a problem or a particular way to achieve a desired outcome that purports to improve interjurisdictional operability of devices to detect health events.
For example, as stated in paragraph [0005] of the Specification, "[t]o illustrate by way of example, it may the case that simply having an implanted medical device runs a person afoul of their local jurisdiction; concurrently, another person may suffer or die needlessly because the same implanted medical device has not been approved in their local jurisdiction. In the United States, a government agency, such as the Food and Drug Administration (FDA), may have approved the implanted medical device for public use, but the FDA lacks authority outside of the US, and the same medical device may be prohibited in countries across Europe. The present disclosure provides addition examples of usage scenarios that have a tendency to create obstacles for people simply because of where a person lives."
Claim 1 is directed to the particular solution of reconfiguring patient datasets that allows interoperability between the separated logical components or between the logical component for the running algorithm and/or an IMD. 3
Claim 1 recites the particular solution of accessing, based on a usage scenario, a data structure comprising an algorithm for health event detection in patient data generated by at least one of the medical device or the other device of the patient, wherein association of the algorithm and the usage scenario in the data structure indicates that use of the algorithm for the usage 3 See paragraphs [0045-0047] of Specification. scenario complies with one or more jurisdictional requirements, in response to selection of the algorithm, generate information operative to perform an automatic configuration of the patient data to be interoperable with logic implementing the algorithm, and apply the selected algorithm to the automatically configured data.
The particular system recited in claim 1 provides an improvement of automatically configuring patient dataset to be interoperable with logic implementing the algorithm so a medical device is capable of seamlessly operating in various jurisdictions.4
Therefore, in accordance with the considerations for items (1)-(3) of Step 2A Prong Two of the Memo, claim 1 does not recite only the idea of a solution or outcome, but claim 1 covers a particular technical solution to a problem or a particular way to achieve a desired outcome and/or an improvement to existing technology (e.g., generate information to automatically configure patient data generated by a medical device or other device of patient to be interoperable with logic implementing an algorithm for health event detection).
Furthermore, Applicant respectfully submits that not finding that claim 1 particularly applies the alleged judicial exception is evidence of what the Appeals Review Panel of the Patent Trial and Appeal Board recently characterized as "overbroad reasoning . . . [that] is perhaps understandable given the confusing nature of existing § 101 jurisprudence."5 In its Decision, the Appeals Review Panel of the Patent Trial and Appeal Board emphasized that "§§ 102, 103, and 112 are the traditional and appropriate tools to limit patent protection to its proper scope."6 Accordingly, in view of the above, the claims are directed to patent eligible subject matter under either Step 2A, Prong 2 (e.g., Alice step 1) because the claims are directed to a specific, practical application that provides a specific technological improvement in the technology of an implanted medical device to be placed into an MRI mode. For at least these reasons, claims 1-20 recite patentable subject matter under 35 U.S.C. § 101. Applicant therefore respectfully requests reconsideration and withdrawal of this rejection. See paragraphs [0005-0008] and [0045-0047] of Specification.s Decision on Request for Rehearing, Appeal 2024-000567, pg. 9 Id.at pg. 10.
Examiner appreciates applicant’s arguments but respectfully does not find them persuasive. The MPEP states The Alice/Mayo two-part test is the only test that should be used to evaluate the eligibility of claims under examination. While the machine-or-transformation test is an important clue to eligibility, it should not be used as a separate test for eligibility. Instead it should be considered as part of the "integration" determination or "significantly more" determination articulated in the Alice/Mayo test. Bilski v. Kappos, 561 U.S. 593, 605, 95 USPQ2d 1001, 1007 (2010). See MPEP § 2106.04(d) for more information about evaluating whether a claim reciting a judicial exception is integrated into a practical application and MPEP § 2106.05(b) and MPEP § 2106.05(c) for more information about how the machine-or-transformation test fits into the Alice/Mayo two-part framework.
The enumerated groupings of abstract ideas are defined as:
1) Mathematical concepts – mathematical relationships, mathematical formulas or equations, mathematical calculations (see MPEP § 2106.04(a)(2), subsection I); (Mathematical Calculations - A claim that recites a mathematical calculation, when the claim is given its broadest reasonable interpretation in light of the specification, will be considered as falling within the "mathematical concepts" grouping. A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.)
2) Certain methods of organizing human activity – fundamental economic principles or practices (including hedging, insurance, mitigating risk); commercial or legal interactions (including agreements in the form of contracts; legal obligations; advertising, marketing or sales activities or behaviors; business relations); managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions) (see MPEP § 2106.04(a)(2), subsection II); and
3) Mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion) (see MPEP § 2106.04(a)(2), subsection III).
Examiners should determine whether a claim recites an abstract idea by (1) identifying the specific limitation(s) in the claim under examination that the examiner believes recites an abstract idea, and (2) determining whether the identified limitations(s) fall within at least one of the groupings of abstract ideas listed above. Furthermore, the MPEP state in 2106.04(d), “Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical applications.”
The positively recited claim 1 (as representative) is directed to a judicial exception (i.e. certain methods of organizing human activity) as merely following rules or instructions to determine a health event in patient data this is abstract in substance as a human with or without the aid of a computer environment can determine based on abstract algorithm or reasoning whether data meets jurisdictional requirements and analyze data to determine a health event by following rules and instructions. Being implemented by a computer environment automatically does not make the recited claim dispositive of being certain methods of organizing human activity. Further examiner notes that the abstract idea was completely characterized by examiner where the abstract elements such as “generate information operative to perform an automatic configuration of the patient data to be interoperable with logic implementing the algorithm," and "apply the selected algorithm to the automatically configured data" were recited from the claim and concluded as abstract, the abstract idea summarized, and classified as following rules or instructions within certain methods of organizing human activity. Therefore Step 2A-1 is established and satisfied by examiner. Furthermore, the claim is taken at its broadest reasonable interpretation based on claim construction and the specification is not read into the claims and its not would a human do it but could a human do it and it is not dispositive of being an abstract idea just because a computer is used. The claim construction is broad and basic algorithm as claimed with no further limiting elements themselves are mathematical based elements which are used by humans today with pen and paper or applied by a general purpose computer environment for efficiency and do not negate that they are abstract or used in this case to detect health event following jurisdictional requirements for data which is still following rules and instructions within certain methods of organizing human activity.
Further responding to applicants arguments, the judicial exception (abstract idea) cannot integrate itself into a practical application but identification of any additional elements recited in the claim can be evaluated to determine if the additional elements integrate the exception into a practical application. The claims additional elements are not recited as being an improvement to a technology field or a technology confined to the computer environment in which the claims recite. A technical problem must first be identified in instant application specification and reflected in the claims. Problems recited in the arguments are abstract problems related detecting health events for data confirmed to follow jurisdictional requirements or data management. There are no additional elements recited other than the general purpose computer elements ([0224]-[0227]). The additional elements are apply it and the claims do not recite technical improvements to the computer or medical device whether alone or in combination with the abstract idea. The abstract idea of data configuration management and detection of health events cannot bring forth the practical application as it is a part of the abstract idea. Examiner did not over broaden the claims as in fact the claims are very broad and if applicant’s line of reasoning were correct Alice corp. would have been deemed eligible. Examiner maintains the claims are directed to an abstract idea and do not integrate into a practical application. Therefore, they also do not amount to significantly more.
Examiner maintains the 35 U.S.C § 101 rejection
Response to Arguments Regarding 35 U.S.C § 102/103 Rejections
Applicant’s arguments on pages 6-7 of remarks have been considered. Applicant argues the 35 U.S.C § 102/103 rejection should be withdrawn for the following reasons:
In order to support an anticipation rejection under 35 U.S.C. § 102(a)(1), it is well established that a prior art reference must disclose each and every element of a claim. This well-known rule of law is commonly referred to as the "all-elements rule."7 If a prior art reference fails to disclose any element of a claim, then rejection under 35 U.S.C. § 102(a)(1) is improper.8 Haller fails to disclose all of the elements of the claims, as required by 35 U.S.C. § 102(a)(1), and provides no apparent reason for modification to include such features.
Claim 1 recites: "in response to selection of the algorithm, generate information operative to perform an automatic configuration of the patient data to be interoperable with logic implementing the algorithm" Paragraph [0227] of Haller states: "remote system 130 and/or data resource system 112 may be configured to automatically review the various hardware configurations and software applications contained in communication module 100 and/or IMD 10. Updated software applications may therefore be installed automatically, if available and approved for installation in a particular communication module 100 and/or IMD 10. In some cases, such software installation may be a byte level update to software already residing in the communication module 100 and/or IMD 10. In other cases, such software installation may comprise replacing an outdated software application with a new application. In one method of the present invention, remote health care provider 136 is presented with the choice of whether or not to proceed with the installation of new software applications. Remote health care provider 136 may also disable or defer installation of new or updated software if communication module 100 is detected as communicating with IMD 10. Such a safety feature helps prevent interference with communications between communication module 100 and IMD 10."
Haller merely describes replacing outdated software applications with a new software application. Haller also describes disabling or deferring installation of new or updated software if communication module 110 is communicating with IMD 10.
However, Haller does not describe configuring patient data, much less describe to perform an automatic configuration of the patient data to be interoperable with logic implementing the algorithm, as recited in claim 1.
Therefore, Haller does not disclose or suggest in response to selection of the algorithm, generate information operative to perform an automatic configuration of the patient data to be interoperable with logic implementing the algorithm, as is recited in claim 1.
In view of the above, Applicant respectfully submits independent claim 1 is patentable over the cited references. Applicant respectfully submits independent claims 7 and 15 are patentable over the cited references for at least the reasons given above for claim 1.
For at least the reasons discussed above, independent claims 1, 7, and 15 are patentable over Haller. The dependent claims, i.e., claims 2-6, 8-14, and 16-20, incorporate the requirements of the respective independent claims.9 Accordingly, the dependent claims are likewise patentable.
Examiner appreciates applicant’s argument but does not find it persuasive. After thorough consideration examiner notes that the broadest reasonable interpretation based on the constructed claim language. Claim 1 (as representative) recites the limitation argued with very broad language which reads “in response to selection of the algorithm, generate information operative to perform an automatic configuration of the patient data to be interoperable with logic implementing the algorithm;” in which examiner interpreted this claim in the broadest reasonable interpretation commiserate with the broad way it is claimed which is that an algorithm logic is generating information which can be any information as it is not limited in the claim and this algorithm logic must be operational or in other words have the ability to perform automated configuration of the patient data (as it is not claimed that it does perform) so that the data is interoperable with this algorithm which in plain definition means anytime of formatting as no specific limitation or affirmative language is recited in the claim to how this is operatively performed or how the interoperability is implemented with software implementing the algorithm. Therefore examiner cites to Haller who matches the broad claim construction by teaching in Fig. 12B steps 148-156, and in paragraph [0227] which discloses, “In a preferred embodiment of the present invention, and regardless of the purpose for which communication module 100 and/or IMD 10 is connected with or interrogated by remote system 130, remote system 130 and/or data resource System 112 may be configured to automatically review the various hardware configurations and Software applications contained in communication module 100 and/or IMD 10. Updated software applications may therefore be installed automatically, if available and approved for installation in a particular communication module 100 and/or IMD 10. In some cases, such software installation may be a byte level update to Software already residing in the communication module 100 and/or IMD 10.” Therefore Haller is teaching that software applications approved by the governing body in the country in which they are being used are accessed, generated, and installed updating the configuration information within the IMD and can for example generate an automatic invoice. This is clearly teaching at the broad level required by the claim that Haller generates information such as configuration information which is operational to perform generating an invoice for services provided to a patient for example which is formatted from the algorithmic logic which are accessed generated and installed meeting jurisdictional requirements of the governing body of that country therefore necessarily this data generated from this software logic is formatted and made interoperable with the logic implanting the algorithm. It is not until the following step of the claim which recites limitation stating “and apply the selected algorithm to the automatically configured data.” That the claim actually executes affirmatively on application of the algorithm to the automatically configured data in which examiner cites to Haller as Haller teaches that the selected IMD algorithm software is applied to data known about the patient to detect a health even such as needing to call an ambulance or delivering of therapy. See paragraph [0235] which discloses, “If, on the other hand, the analysis reveals that a problem exists in respect of any one or more of IMD 10, communication module 100, mobile telephone or PDA 110, and/or patient 5, then remote system 130 and/or health care provider 136 determines an appropriate remedial response to the problem, Such as changing the operating parameters of IMD 10, communication module 100 and/or mobile tele phone or PDA 110, delivering a therapy to the patient (e.g., a pacing, cardioVerting or defibrillating therapy, or administration of a drug or other beneficial agent to patient 5), or instructing patient 5 by audio, Visual or other means to do Something Such as lie down, go to the hospital, call an ambulance, take a medication, or push a button.” And see paragraph [0236] which discloses, “The remedial response or therapy determined in step 517 is next executed at step 519 by remote health care provider 136 or remote system 130 and relayed at step 521 via communication System 120 to communication module 100 and/or IMD 10 via mobile phone or PDA110. After the remedial response or therapy has been delivered, at step 525 communication module and/or mobile telephone 110 may Send a confirmatory message to remote System 130 and/or remote care giver 136 indicating that the remedial response or therapy has been delivered to patient 5 and/or IMD 10.”
Therefore, examiner based on broadest reasonable interpretation maintains the 102 rejection.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ashley Elizabeth Evans whose telephone number is (571) 270-0110. The examiner can normally be reached Monday – Friday 8:00 AM – 5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached on (571) 270-1813. The fax phone number for the organization where this application or proceeding is assigned 571-273-8300.
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/ASHLEY ELIZABETH EVANS/Examiner, Art Unit 3687
/MAMON OBEID/Supervisory Patent Examiner, Art Unit 3687