DETAILED ACTION
Acknowledgements
This office action is in response to the claims filed May 15, 2026.
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 .
Request for Continued Examination
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 claims (claim 1 as representative):
a patient;
access, based on a usage scenario, a data structure comprising an algorithm for health event detection in patient data comprising cardiac electrical activity data comprising at least one of cardiac electrogram (EGM) data and electrocardiogram (ECG) 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, pre-process the cardiac electrical activity data into pre-processed data, wherein the pre-processed data is configured to conform for the logic implementing the algorithm;
and apply the selected algorithm to the prep-processed data.
The abstract idea is “certain methods of organizing human activity” by following rules and instructions to format data for an algorithm to detect 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
an input interface
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])
The additional element, (c), is recited as merely “apply-it” or an equivalent to gather data
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 format data for an algorithm to detect 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 § 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 1-15 are rejected to under 35 U.S.C. 103 as being unpatentable over Haller et. al (hereinafter Haller) (US20020082665A1) in view of Volpe et. al (hereinafter Volpe) (US11534098B2)
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 microprocessor, 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, …[…]… for the logic implementing the algorithm and apply the algorithm …[…]… ([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.” 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.”)
However, Haller does not explicitly state:
comprising cardiac electrical activity data comprising at least one of cardiac electrogram (EGM) data and electrocardiogram (ECG) data pre-process the cardiac electrical activity data into pre-processed data, wherein the pre-processed data is configured to conform to an input interface…[…]……[…]…to the pre-processed data.
However, Volpe teaches:
comprising cardiac electrical activity data comprising at least one of cardiac electrogram (EGM) data and electrocardiogram (ECG) data…[…]…pre-process the cardiac electrical activity data into pre-processed data, wherein the pre-processed data is configured to conform to an input interface…[…]… to the pre-processed data.
(abstract discloses, “The monitoring system includes pre-processing circuitry configured to receive a raw physiological signal . The pre - processing circuitry is configured to produce a primary physiological signal and a secondary physiological signal . Each of the primary and secondary physiological signals are conditioned . The primary conditioned physiological signal is directed to a primary monitoring device such as a hospital wearable defibrillator device…[…]..” and see e.g. fig. 9)
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 Volpe’s teachings of ECG data pre-processed for a specific wearable, 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 Volpe 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 chosen data of Volpe and the pre-processing improve the tracing and consistency across versions.
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 a plurality of algorithms comprising the algorithm, 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 a 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 …[…]…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 …[…]…([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.”)
However, Haller does not explicitly state:
comprising cardiac electrical activity data comprising at least one of cardiac electrogram (EGM) data and electrocardiogram (ECG) data pre-process the cardiac electrical activity data into pre-processed data, wherein the pre-processed data is configured to conform to an input interface…[…]……[…]…to the pre-processed data.
However, Volpe teaches:
comprising cardiac electrical activity data comprising at least one of cardiac electrogram (EGM) data and electrocardiogram (ECG) data…[…]…pre-process the cardiac electrical activity data into pre-processed data, wherein the pre-processed data is configured to conform to an input interface…[…]… to the pre-processed data.
(abstract discloses, “The monitoring system includes pre-processing circuitry configured to receive a raw physiological signal . The pre - processing circuitry is configured to produce a primary physiological signal and a secondary physiological signal . Each of the primary and secondary physiological signals are conditioned . The primary conditioned physiological signal is directed to a primary monitoring device such as a hospital wearable defibrillator device…[…]..” and see e.g. fig. 9)
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 Volpe’s teachings of ECG data pre-processed for a specific wearable, 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 Volpe 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 chosen data of Volpe and the pre-processing improve the tracing and consistency across versions.
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 and Volpe as well as motivations to combine 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 a 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 a 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 or another device; ([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 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)
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, …[…]…for the 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 …[…]…([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.”)
However, Haller does not explicitly state:
comprising cardiac electrical activity data comprising at least one of cardiac electrogram (EGM) data and electrocardiogram (ECG) data pre-process the cardiac electrical activity data into pre-processed data, wherein the pre-processed data is configured to conform to an input interface…[…]……[…]…to the pre-processed data.
However, Volpe teaches:
comprising cardiac electrical activity data comprising at least one of cardiac electrogram (EGM) data and electrocardiogram (ECG) data…[…]…pre-process the cardiac electrical activity data into pre-processed data, wherein the pre-processed data is configured to conform to an input interface…[…]… to the pre-processed data.(abstract discloses, “The monitoring system includes pre-processing circuitry configured to receive a raw physiological signal . The pre - processing circuitry is configured to produce a primary physiological signal and a secondary physiological signal . Each of the primary and secondary physiological signals are conditioned . The primary conditioned physiological signal is directed to a primary monitoring device such as a hospital wearable defibrillator device…[…]..” and see e.g. fig. 9)
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 Volpe’s teachings of ECG data pre-processed for a specific wearable, 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 Volpe 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 chosen data of Volpe and the pre-processing improve the tracing and consistency across versions.
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 Volpe et. al (hereinafter Volpe) (US11534098B2) and in further view of Miller et. al (hereinafter Miller) (US11461691B2)
As per claim 16, Haller and Volpe do 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 and Volpe’s teachings 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…[…]…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, Volpe does teach:
pre-processing the cardiac electrical activity data (abstract discloses, “The monitoring system includes pre-processing circuitry configured to receive a raw physiological signal . The pre - processing circuitry is configured to produce a primary physiological signal and a secondary physiological signal . Each of the primary and secondary physiological signals are conditioned . The primary conditioned physiological signal is directed to a primary monitoring device such as a hospital wearable defibrillator device…[…]..” and see e.g. fig. 9)
However, Volpe does not explicitly teach:
The method of claim 16, wherein…[…]…comprises: determining updated parameter data that matches the characteristics information for the algorithm, the characteristics information comprising an input parameter or an output parameter.
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 Volpe’s teachings for the same reasons given for claim 1.
However, Miller does teach:
The method of claim 16, wherein…[…]…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 pre-processing the cardiac electrical activity data 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, Volpe does teach:
pre-processing the cardiac electrical activity data (abstract discloses, “The monitoring system includes pre-processing circuitry configured to receive a raw physiological signal . The pre - processing circuitry is configured to produce a primary physiological signal and a secondary physiological signal . Each of the primary and secondary physiological signals are conditioned . The primary conditioned physiological signal is directed to a primary monitoring device such as a hospital wearable defibrillator device…[…]..” and see e.g. fig. 9)
However, Volpe does not explicitly teach:
The method of claim 16, wherein…[…]…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.
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 Volpe’s teachings for the same reasons given for claim 1.
However, Miller does teach:
The method of claim 16, wherein…[…]…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 …[…]…comprises: generating instructions that a client application running on the other device executes to apply 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.”)
However, Haller does not teach:
pre-processing the cardiac electrical activity data
However, Volpe does teach:
pre-processing the cardiac electrical activity data (abstract discloses, “The monitoring system includes pre-processing circuitry configured to receive a raw physiological signal . The pre - processing circuitry is configured to produce a primary physiological signal and a secondary physiological signal . Each of the primary and secondary physiological signals are conditioned . The primary conditioned physiological signal is directed to a primary monitoring device such as a hospital wearable defibrillator device…[…]..” and see e.g. fig. 9)
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 Volpe’s teachings for the same reasons given for claim 1.
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.”)
Response to Arguments Regarding 35 U.S.C § 101 Rejection
The applicant argues on pages 1-8 of the submitted remarks that the claims under 35 U.S.C § 101 are eligible for the following:
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. Specifically, the Office Action rejected claims 1-20 under 35 U.S.C. § 101 based on an assertion that these claims are directed to an abstract idea without significantly more. Contrary to the assertions by the Office Action, claims 1-20 are not directed to an abstract idea and recite significantly more than the alleged abstract idea identified by the Office Action. The claims are therefore compliant with the requirements of 35 U.S.C. § 101 and are patent eligible.
According to MPEP § 2106(III), the claims should be analyzed using a two-step subject matter eligibility test. The two-step subject matter eligibility test includes, Step 1, Step 2A Prong 1, Step 2A Prong 2, and Step 2B. If any of Step 2A Prong 1. Step 2A Prong 2, or Step 2B are satisfied, then the claims recite patent eligible subject matter.
In support of the rejection, the Office Action alleged that claim 1 is "directed to an abstract idea without significantly more." The Office Action specifically asserted that the "abstract idea is 'certain methods of organizing human activity' by following rules and instructions to determine a health event in patient data."
The independent claims, including inter alia, claim 1 and its dependent claims comply with the requirements of 35 U.S.C. § 101 under a streamlined analysis according to Step 2A Prong 1, Step 2A Prong 2, and Step 2B. Claim 1, as a whole, is not a method of organizing human activity, integrates the allegedly recited judicial exception into a practical application, and amounts to significantly more than the alleged judicial exception, satisfying Step 2A Prong 1, Step 2A Prong 2, and Step 2B respectively.
Step 2A of the SME Analysis
The Office must apply a two-pronged analysis for determining whether a claim is patentable under step 2A.4 Under prong one of the two-pronged analysis, the MPEP states that the Office should "evaluate whether the claim recites a judicial exception."5 More specifically, the MPEP advises that abstract ideas fall within at least one of three enumerated groupings - mathematical concepts, certain methods of organizing human activity, and mental processes.6 If the claim recites a judicial exception, the claim requires further analysis under prong two. With respect to prong two, the MPEP states that the Office "should evaluate whether the claim as a whole integrates the recited judicial exception into a practical application of the exception."7 If the claim as a whole integrates the recited judicial exception into a practical application of the exception, the claim is not directed to the judicial exception, and the claim is patentable under 35 U.S.C. § 101.
Step 2A Prong 1
With respect to prong one of Step 2A, the Office asserted that the claims fall within methods of organizing human activity.8 Applicant respectfully disagrees.
The Office Action alleged that the "abstract idea is 'certain methods of organizing human activity' by following rules and instructions to determine a health event in patient data."9 MPEP 2106.04(a)(2)(II) indicates that "this grouping is limited to activity that falls within the enumerated sub-groupings of fundamental economic principles or practices, commercial or legal interactions, and managing personal behavior and relationships or interactions between people, and is not to be expanded beyond these enumerated sub-groupings except in rare circumstances."10 The recitations of claim 1 are not directed to fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people.
The Office Action attempts to categorize the recitations of claim 1 as being directed to "following rules and instructions to determine a health event in patient data;"11 however, MPEP 2106.04(a)(2)(II)(C) clarifies that this sub-grouping covers concepts like "social activities, teaching, and following rules or instruction."12 This includes examples such as a method of playing a dice game,13 assigning hair designs to balance head shape,14 or a series of instructions of how to hedge risk.15 Although the processing circuitry of claim 1 does execute instructions, these are not "rules" as envisioned by the exception. Claim 1 is not directed to managing personal behavior such as following rules or instructions. Reducing processing circuitry configured to access, based on a usage scenario, a data structure comprising an algorithm for health event detection in patient data comprising cardiac electrical activity data comprising at least one of cardiac electrogram (EGM) data and electrocardiogram (ECG) data and in response to selection of the algorithm, pre-process the cardiac electrical activity data into pre-processed data, wherein the pre-processed data is configured to conform to an input interface for the logic implementing the algorithm n to being merely "following rules," would directly contradict the MPEP which requires that the organizing human activity group "not [] be expanded beyond these enumerated sub-groupings except in rare circumstances."
As such, claim 1 is not directed to organizing human activity or any abstract idea and therefore is patent eligible under step 2A prong 1 of 35 U.S.C. § 101.
Step 2A Prong 2
Applicant maintains that the claims do not recite an abstract idea. But even if the claims recite an abstract idea, which Applicant does not acquiesce, the claims as a whole integrate the alleged abstract idea into a practical application of the alleged abstract idea. A claim that integrates an abstract idea into a practical application of the abstract idea, applies the abstract idea in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim amounts to more than monopolizing the abstract idea.l
In a recent memo from Deputy Commissioner Kim, the Deputy Commissioner noted that an "important consideration in determining whether a claim improves technology or a technical field is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome."18 Specifically, the Deputy Commissioner noted that the "examiner is reminded to consult the specification to determine whether the disclosed invention improves technology or a technical field, and evaluate the claim to ensure it reflects the disclosed improvement."19 Additionally, although the specification "must describe the invention such that the improvement would be apparent to one of ordinary skill in the art"20 the "claim itself does not need to explicitly recite the improvement described in the specification."21
Applicant's specification discloses improvements to technology or technical field and states in part:
A medical device such as IMD 10 may generate patient data using raw device measurements and/or sensed physiological input, however, in some examples, such data may not be compatible with the characteristics of the algorithm, inhibiting an application of the algorithm to the raw device measurements and/or sensed physiological input; therefore, by pre-processing the patient data for the approved algorithm according to parameters and other appropriate configuration details defined in device profile 400, the medical system may conform the patient data to be compatible to the algorithm.22
The particular algorithm/model version may be incompatible with the patient data; while the monitoring service may refuse to apply the particular algorithm/model version based on that incompatibility, the monitoring service may exercise its option to override the rejection, thereby applying the particular algorithm/model version to the patient data. An override may be authorized if the monitoring service successfully pre-processes the patient data to be compatible with the particular algorithm/model23 automatically configure the information in these samples into a suitable format for input to a validated algorithm. Having the samples properly configured into formatted patient data that is compatible with the validated algorithm enables an application of the algorithm without errors.24
As described in the preceding excerpts from Applicant's specification, Applicant's specification discloses a litany of improvements to the field of jurisdictional compliance of algorithms, such that the improvements would be apparent to one of ordinary skill in the art. At least for the reasons set forth by the Federal Circuit in CardioNet, an improvement to the performance of a medical device constitutes an improvement to the technical field. Independent claim 1 similarly recites features that improve the performance of a device configured to pre- process the cardiac electrical activity data. For example, in CardioNet, the Federal Circuit found that "the claims of the '207 patent do not 'fit into the familiar class of claims that' focus on 'certain independently abstract ideas that use computers as tools,"' and "[r]ather . . . they fit into the class of claims that focus on "an improvement in computers [and other technologies] as tools. '"25 Likewise, the Office should similarly find that Applicant's claims fit into a class of claims that focus on an improvement in technology.22 Applicant's originally filed specification, para. [0172]. 23 Applicant's originally filed specification, para. [0028]. 24 Applicant's originally filed specification, para. [0188]. 25 CardioNet, 955 F.3d at 1371. For at least these reasons, even if Applicant's claims recites an abstract idea, which Applicant does not acquiesce, the claims as a whole integrate the recited judicial exception into a practical application of the alleged abstract idea.
Step 2B of the SME Analysis
Applicant submits that the claims are not directed to an abstract idea, but even if they were, the claims recite additional elements that amount to significantly more than the alleged abstract idea. In determining whether a claim recites additional elements that amount to significantly more than an abstract idea, the Office should (1) identify any additional elements recited in the claim that are beyond the abstract idea, and (2) evaluate those additional elements individually and in combination to determine whether they contribute to an inventive concept.26 Limitations that courts have found to qualify as significantly more than the alleged abstract idea include improvements to the functioning of a computer, other technology, or technical field.27
The Office asserted that the claims do "not include additional elements that are sufficient to amount to significantly more than the judicial exception."28 The Office continued and asserted that 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."29 Applicant submits that, with respect to claim 1 for example, access, based on a usage scenario, a data structure comprising an algorithm for health event detection in patient data comprising cardiac electrical activity data comprising at least one of cardiac electrogram (EGM) data and electrocardiogram (ECG) data ... use of the algorithm for the usage scenario complies with one or more jurisdictional requirements in response to selection of the algorithm, pre-process the cardiac electrical activity data into pre- processed data, wherein the pre-processed data is configured to conform to an input interface for the apply the algorithm to the pre-processed data improves the functioning of a medical device, and therefore does not represent mere data manipulation by generic computing components.
Additionally, Deputy Commissioner Kim has noted that "[e]xaminers are cautioned not to oversimplify claim limitations and expand the application of the 'apply it' consideration. Moreover, examiners are reminded that the "apply it" consideration often overlaps with the improvements consideration."30 As noted throughout above, the specification and claims detail an improvement in the technology field. Since claim 1 recites at least one of these improvements to the technology field, claim 1 is patent eligible since it does not represent "mere instructions to apply the exception using a generic computer component."31
For at least these reasons, claim 1 as a whole integrates the alleged judicial exception into a practical application of the alleged abstract idea. Therefore, claim 1 is not directed to a judicial exception and is patent eligible for at least the reasons under Step 2A Prong 2. Independent claims 7 and 15 have similar recitations to claim 1 and therefore are likewise patentable for at least the same reasons under Step 2A Prong 1, Step 2A Prong 2, and Step 2B. 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 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.
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. Pre-processing data to make sure it can be logically ran by the algorithm is something a certain human activity as the algorithm selection of this algorithm conclusory in the claim therefore it is a part of the abstract idea and further the pre-processing is also broad and a human could even with help of a computer review data to ensure it will be compatible with the logical algorithm applied to come to some health event detection. Being implemented by a computer environment automatically does not make the recited claim dispositive of being certain methods of organizing human activity. The claim must be taken at its broadest reasonable interpretation based on claim construction and the specification is not read into the claims and it’s 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. The examples in the MPEP are not meant to be an ipsissima verba test against other applications such as instant applications but rather explanatory in nature as other precedential case law is also considered certain methods of organizing human activity in business methods such as what is claimed by applicant thus each case turns on its on facts to determine enumerated subgrouping, therefore it is reasonable the recited claims are directed to certain methods of organizing human activity for the aforementioned reasoning given by examiner.
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. Applicant argues the claims recite improvements to the field of jurisdictional compliance of algorithms, but applicant further recites paragraphs of the specification without identifying where this improvement is reflected in the claims. Examiner notes that although definitions and understanding can be gleaned from the specification to understand an interpret the claims, the specification cannot be read into the claims. The claims must at least reflect under broadest reasonable interpretation to the level of detail argued by applicant which they do not. The claims do not recite or reflect an improvement to the technology of jurisdictional compliance of algorithms as the claims broadly recite the selection and application of the algorithm with no further limiting technical reflection of an improvement to the computer or other technology which improves this compliance of the algorithms. Rather the claims recite abstract idea of associating pre-processed data with algorithm and applying the algorithm at a broad level which examiner did not overgeneralize or simplify as the claim uses little words rather than pre-process and algorithm with no further technical steps. There are no additional elements recited other than the general purpose computer elements ([0224]-[0227]). The additional elements are apply it level 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. Further, CardioNet and the instant application have no nexus in claimed subject matter of fact pattern as CardioNet went beyond generic computer implantation of data processing and application and tied back to a clear computer confined technical problem in the specification of the underpinned technology. 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 Rejection
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 computing 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.
Conclusion
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
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