DETAILED ACTION
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 .
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.
Claim(s) 1-36, 38-53 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demmer et al. (US 2022/0211332 A1, “Demmer”) in view of Linder et al. (US 2002/0181680 A1, “Linder”).
As to claims 1, 18, 35, 53, Demmer discloses a method of determining telemetry data that is to be transmitted to a remote location, comprising:
receiving patient data describing a state of a patient who uses a medical device (processing circuitry receives sensor data collected by a medical device, the sensor data related to at least one physiological parameter of a patient, para. 0009);
receiving medical device data describing a state of the medical device (medical device data, such as battery capacity or other performance data of the medical device, para. 0037);
assessing patient risk based at least in part on the patient data that is received, the patient risk reflecting (i) a likelihood that the patient has entered or will enter a patient risk state representative of one or more predetermined physical conditions that do not meet a prescribed level of patient health and (ii) a severity level of the patient risk state (system 10 may determine, based on at least the sensor data, a risk-level of the patient’s health; para. 0041);
assessing medical device risk based at least in part on the medical device data that is received, the medical device risk reflecting (i) a likelihood that the medical device has entered or will enter a medical device risk state indicating that operability of the medical device does not meet a prescribed standard and (ii) a severity level of the device risk state; and
selecting for transmission to a remote location selected telemetry data associated with the medical device and/or the patient in a manner that is based at least in part on the assessed medical device risk and the assessed patient risk (an alert is provided via network 14 based on a severity of a potential clinical event; para. 0064, 0091; in the event of a high risk-level of the patient’s health, monitoring may take place more frequently, para. 0023; sensor data may be collected more frequently and for longer periods, para. 0090).
Demmer differs from claims 1, 18, 35, 53 in that it does not disclose the above underlined limitation.
Linder teaches receiving medical device performance data (para. 0026) and assessing proper operation of a medical device based on analysis of the operational characteristics of the device (para. 0035). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer with the above teaching of Linder in order to monitor both the patient and the equipment itself, as taught by Linder (para. 0011).
As to claims 2, 19, 38, Demmer in view of Linder teaches: receiving environmental data describing a state of an environment in which the medical device and/or the patient is located, wherein assessing the medical device risk and the patient risk is further based at least in part on the environmental data (Demmer: data on the environmental conditions are measured and used in conjunction with the patient sensor data to determine the risk-level of the patient; para. 0084, 0086, 0099).
As to claims 3, 20, 39, Demmer in view of Linder teaches: causing an adjustment to an amount, type and/or frequency of receipt of the medical device data that is received based at least in part on the assessed medical device risk and the assessed patient risk (Demmer: in the event of a high risk-level of the patient’s health, monitoring may take place more frequently, para. 0023; sensor data may be collected more frequently and for longer periods, para. 0090; Linder: changes to wear-time recommendations are recommended based on device operation problems to ensure correct operation of the device as well as the health of the patient, para. 0028-0029).
As to claims 4, 5, 21, 22, 40, 41, Demmer in view of Linder teaches: causing an adjustment to an amount, type and/or frequency of receipt of the patient data that is received based at least in part on the assessed medical device risk and the assessed patient risk (Demmer: in the event of a high risk-level of the patient’s health, monitoring may take place more frequently, para. 0023; sensor data may be collected more frequently and for longer periods, para. 0090).
As to claims 6, 23, Demmer in view of Linder teaches: wherein selecting for transmission selected telemetry data in a manner that is based at least in part on the assessed medical device risk and the assessed patient risk includes determining a type of telemetry data that is to be transmitted to the remote location and/or a frequency at which the telemetry data is to be transmitted to the remote location (Demmer: a particular type of telemetry data is requested based on assessed patient medical risk, para. 0025; patient sensor data may be collected more frequently and for longer periods based on assessed patient medical risk, para. 0090).
As to claims 7, 24, 42, Demmer in view of Linder teaches: wherein the types of telemetry data that are selected and/or the frequency at which the telemetry data is selected for transmission increases as the assessed medical device risk and/or the assessed patient risk increases (Demmer: a particular type of telemetry data is requested based on increased patient medical risk, para. 0025; patient sensor data may be collected more frequently and for longer periods based on increased patient medical risk, para. 0023, 0090-0091, 0108).
As to claims 8, 25, 43, Demmer in view of Linder teaches: wherein the types of telemetry data that are selected and/or the frequency at which the telemetry data is selected for transmission decreases as the assessed medical device risk and/or the assessed patient risk decreases (Demmer: if a normal or low risk level of the patient’s health is determined, the individual is prompted to take no action, para. 0023, 0091, 0108; in response to the risk level being low, sensor data may be collected less frequently and for a shorter period, e.g. once every other day and for a period of a minute, para. 0090).
As to claims 9, 26, 44, Demmer in view of Linder teaches: wherein the medical device is a continuous glucose monitor and the patient data includes blood glucose data (Demmer: glucose meter may collect data continuously, para. 0025, 0031, 0078, 0105).
As to claims 10, 27, 45, Demmer in view of Linder teaches: wherein the medical device is selected from the group including pacemakers, implantable defibrillators, medicant delivery devices and neurostimulation devices (Demmer: medical device may be a pacemaker, para. 0018, implantable cardioverter-defibrillator, neurostimulator, para. 0049, drug delivery device, para. 0052).
As to claims 11, 28, 46, Demmer in view of Linder teaches: locally storing telemetry data that is not selected for transmission (Demmer: sensed data collected from medical device is stored locally, and transmitted in response to a request, para. 0073).
As to claims 12, 29, 47, Demmer in view of Linder teaches: selecting for transmission to the remote location at least some of the locally stored telemetry data when the assessed medical device risk and/or the assessed patient risk increases (Demmer: in response to the risk level being high, monitoring is increased and a remote clinician is contacted, para. 0091, 0108).
As to claims 13, 30, 48, Demmer in view of Linder teaches: wherein different types of medical device data are obtained using different types of sensors (Demmer: different types of sensors include an implantable medical device, a blood pressure cuff, a finger pulse oximeter, a glucose meter, a temperature sensor, an ECG sensor, etc., para. 0025, 0028, 0037-0038, 0065).
As to claims 14, 31, 49, Demmer in view of Linder teaches: wherein at least one of the sensors is embedded with the medical device (Demmer: implantable medical device includes sensors, para. 0003-0004, 0049).
As to claims 15, 32, 50, Demmer in view of Linder teaches: wherein at least one of the sensors is external to the medical device (Demmer: sensors may be implemented on wearable devices, para. 0053).
As to claims 16, 33, 51, Demmer in view of Linder teaches: wherein the patient risk and/or the medical device risk is determined using a state calculation that accounts for previous risk states (Demmer: decision tree algorithm may use patient’s risk score over time to determine a present risk-level, para. 0032).
As to claims 17, 34, 36, 52, Demmer in view of Linder teaches: wherein the patient data is received at least in part from the medical device (Demmer: patient sensor data from implantable medical device, para. 0003-0004, 0049).
Claim(s) 37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demmer in view of Linder, as applied to claim 35 above, and further in view of Duffy et al. (US 12,109,033 B1, “Duffy”).
Demmer in view of Linder differs from claim 37 in that it does not teach: assessing an additional risk state of at least one computing device employed in the assessing and/or receiving and wherein receiving telemetry data from the medical device includes receiving an amount and/or frequency of the telemetry data based at least in part on the assessed additional risk state.
Duffy teaches reducing the frequency of communications in an adaptive manner based upon the state of the battery or other information about the operating status of a medical device (col. 13, lines 42-57). Since Demmer in view of Linder teaches reporting medical device data, such as battery capacity or other performance data of the medical device (Demmer: para. 0037), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Demmer in view of Linder with the above teaching of Duffy in order to save power and extend the life of the battery, as taught by Duffy (col. 13, lines 42-57).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lysecky et al. (US 11,868,479 B2) teach a continuous glucose monitor with adaptive software which dynamically assesses risk.
McGrath et al. (US 2023/0346231 A1) teach dynamically adjusting sampling rate based on a battery charge level of a wearable medical device.
Zade et al. (US 2022/0379029 A1) teach a continuous glucose monitor which increases sampling frequency based on the physiological condition of the user.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stella L Woo whose telephone number is (571)272-7512. The examiner can normally be reached Monday - Friday, 8 a.m. to 5 p.m.
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STELLA L. WOO
Primary Examiner
Art Unit 2693
/Stella L. Woo/ Primary Examiner, Art Unit 2693
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