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 .
Claims 1-20 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/15/2025 was in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 18 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Volpe (U.S. Pat. App. Pub. 2016/0253471).
Regarding claim 18, Volpe disclosed a communication method comprising: controlling a local programming electronic device with a remote electronic device to program a medical device of a patient during a dynamic session (update manager, i.e., local programming electronic device, communicating with remote server, i.e., remote electronic device, to update, i.e., program, software modules, ¶[0126]; software modules associated with defibrillator, i.e., medical device, ¶[0119]); monitoring persistent actions of the remote electronic device during the dynamic session (determining, i.e., monitoring, time needed for download/unpacking/installation of software update, i.e., persistent actions, ¶[0159]); determining whether a persistent action of the persistent actions exceeds a static persistent state threshold during the dynamic session (determining time needed for download/unpacking/installation of software update exceeds a time threshold, i.e., static persistent state threshold, ¶[0159]); terminating the dynamic session when the persistent action exceeds the static persistent state threshold (canceling, i.e., terminating, software update, ¶[0159]); and reverting the medical device to a previous configuration in response to terminating the dynamic session to treat the patient (canceling, i.e., reverting, software update, ¶[0159]).
Claim Rejections - 35 USC § 103
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 1-7, 9-14, 16, 17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Volpe (U.S. Pat. App. Pub. 2016/0253471), and further in view of Friedli et al. (U.S. Pat. App. Pub. 2017/0290980), hereinafter Friedli.
Regarding claim 1, Volpe disclosed a communication system comprising: a remote electronic device configured to communicate with a medical device of a patient via a local programming electronic device (update manager, i.e., local programming electronic device, communicating with remote server, i.e., remote electronic device, to update, i.e., program, software modules, ¶[0126]; software modules associated with defibrillator, i.e., medical device, ¶[0119]); the remote electronic device including one or more processors configured to: control operations of the local programming electronic device to program the medical device during a dynamic session (update manager, i.e., local programming electronic device, communicating with remote server, i.e., remote electronic device, to update, i.e., program, software modules, ¶[0126]; software modules associated with defibrillator, i.e., medical device, ¶[0119]); and terminate the dynamic session in response to 1) a persistent action of a user of the remote electronic device exceeding a static persistent state threshold (determining time needed for download/unpacking/installation of software update exceeds a time threshold, i.e., static persistent state threshold, and canceling software update in response, ¶[0159]).
Volpe did not disclose:
terminate the dynamic session in response to 1) a persistent action of a user of the remote electronic device exceeding a static persistent state threshold and 2) a monitored event exceeding a dynamic threshold (emphasis added).
Friedli disclosed:
terminate the dynamic session in response to…2) a monitored event exceeding a dynamic threshold (monitoring laboratory values of patient and determining they are outside predefined ranges, i.e., exceed a dynamic threshold, ¶[0094]-[0095], [0098]; interrupting, i.e., terminating, execution of medical app, i.e., dynamic session, in response, ¶[0099], [0100], [0110]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Volpe to terminate the dynamic session in response to a monitored event exceeding a dynamic threshold as claimed, because doing so would have improved the safety of the medical system (Friedli, ¶[0105]).
Regarding claim 2, Volpe and Friedli disclosed the communication system wherein the one or more processors are further configured to: provide a timer during the dynamic session (time threshold, Volpe, ¶[0159]); and determine whether a duration of the persistent action as determined by the timer exceeds the static persistent state threshold (determining time needed for download/unpacking/installation of software update exceeds a time threshold, i.e., static persistent state threshold, Volpe, ¶[0159]).
Regarding claim 3, Volpe and Friedli disclosed the communication system wherein the one or more processors are further configured to: adjust the timer based on a manual input from the user of the remote electronic device (configuring, i.e., adjusting, time threshold by a user, i.e., manual input, Volpe, ¶[0159]).
Regarding claim 4, Volpe and Friedli disclosed the communication system wherein the one or more processors are further configured to: obtain patient characteristics, clinician characteristics, medical device characteristics, or monitoring characteristics (monitoring, i.e., obtaining, laboratory values of a patient, i.e., patient/medical device/monitoring characteristics, Friedli, ¶[0094]); and determine the static persistent state threshold based on the patient characteristics, the clinician characteristics, the medical device characteristics, or the monitoring characteristics obtained (automatically determining time threshold based on, e.g., system capacity and speed, i.e., medical device characteristics, Volpe, ¶[0159]); and update the static persistent state threshold based on the determining (configuring, i.e., updating, time threshold, Volpe, ¶[0159]).
The combination of references is made under the same rationale as claim 1 above.
Regarding claim 5, Volpe and Friedli disclosed the communication system wherein the one or more processors are further configured to: obtain patient characteristics, medical device characteristics, or monitoring characteristics (monitoring, i.e., obtaining, laboratory values of a patient, i.e., patient/medical device/monitoring characteristics, Friedli, ¶[0094]); and determine the dynamic threshold based on the patient characteristics, the medical device characteristics, or the monitoring characteristics obtained (determining control parameter value, i.e., dynamic threshold, based on physiological parameter, i.e., patient characteristics, Friedli, ¶[0103]).
The combination of references is made under the same rationale as claim 1 above.
Regarding claim 6, Volpe and Friedli disclosed the communication system wherein the monitoring characteristic is related to connectivity between the remote electronic device and the local programming electronic device (monitoring operational state of communication module, i.e., connectivity, Volpe, ¶[0149]).
Regarding claim 7, Volpe and Friedli disclosed the communication system wherein the dynamic session is a programming session (updating, i.e., programming, medical device, Volpe, ¶[0126]).
Regarding claim 9, Volpe and Friedli disclosed the communication system wherein the one or more processors are further configured to: revert the medical device to a previous configuration via the local programming electronic device in response to termination of the dynamic session (canceling, i.e., reverting, software update, Volpe, ¶[0159]).
Regarding claim 10, Volpe disclosed a communication system comprising: a remote electronic device including one or more processors (remote server, i.e., remote electronic device, ¶[0126]) configured to: communicate with a local programming electronic device (update manager, i.e., local programming electronic device, communicating with remote server, ¶[0126]); control the local programming electronic device to program a medical device of a patient (update manager communicating with remote server to update, i.e., control/program, software modules, ¶[0126]; software modules associated with defibrillator, i.e., medical device, ¶[0119]); the local programming electronic device including one or more processors (processors, ¶[0119]-[0120]) configured to: program the medical device during a dynamic session (update, i.e., program, software modules, ¶[0126]; software modules associated with defibrillator, i.e., medical device, ¶[0119]); monitor persistent actions of the remote electronic device during the dynamic session (determining, i.e., monitoring, time needed for download/unpacking/installation of software update, i.e., persistent actions, ¶[0159]);
determine whether a persistent action of the persistent actions exceeds a static persistent state threshold during the dynamic session (determining time needed for download/unpacking/installation of software update exceeds a time threshold, i.e., static persistent state threshold, ¶[0159]); and terminate the dynamic session…2) when the persistent action exceeds the static persistent state threshold (canceling, i.e., terminating, software update, ¶[0159]).
Volpe did not disclose:
monitor at least one of patient characteristics, medical device characteristics, or monitoring characteristics during the dynamic session;
determine a dynamic threshold based on the patient characteristics, the medical device characteristics, or the monitoring characteristics; determine whether the dynamic threshold is exceeded during the dynamic session;
terminate the dynamic session when…the dynamic threshold is exceeded.
Friedli disclosed:
monitor at least one of patient characteristics, medical device characteristics, or monitoring characteristics during the dynamic session (monitoring laboratory values of a patient, i.e., patient/medical device/monitoring characteristics, ¶[0094]);
determine a dynamic threshold based on the patient characteristics, the medical device characteristics, or the monitoring characteristics (determining control parameter value, i.e., dynamic threshold, based on physiological parameter, i.e., patient characteristics, ¶[0103]); determine whether the dynamic threshold is exceeded during the dynamic session (determining parameters are outside predefined ranges, i.e., exceed a dynamic threshold, ¶[0094]-[0095], [0098]);
terminate the dynamic session when…the dynamic threshold is exceeded (interrupting, i.e., terminating, execution of medical app, i.e., dynamic session, in response, ¶[0099], [0100], [0110]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of Volpe to monitor at least one of patient characteristics, medical device characteristics, or monitoring characteristics during the dynamic session, determine a dynamic threshold based on the patient characteristics, the medical device characteristics, or the monitoring characteristics, determine whether the dynamic threshold is exceeded during the dynamic session, and terminate the dynamic session when the dynamic threshold is exceeded as claimed, because because doing so would have improved the safety of the medical system (Friedli, ¶[0105]).
Regarding claim 11, Volpe and Friedli disclosed the communication system wherein the one or more processors of the local programming electronic device are further configured to: provide a timer during the dynamic session (time threshold, Volpe, ¶[0159]); and determine whether a duration of the persistent action as determined by the timer exceeds the static persistent state threshold (determining time needed for download/unpacking/installation of software update exceeds a time threshold, i.e., static persistent state threshold, Volpe, ¶[0159]).
Regarding claim 12, Volpe and Friedli disclosed the communication system wherein the one or more processors of the remote electronic device are further configured to: adjust the timer based on a manual input from the user of the remote electronic device (configuring, i.e., adjusting, time threshold by a user, i.e., manual input, Volpe, ¶[0159]).
Regarding claim 13, Volpe and Friedli disclosed the communication system wherein the one or more processors of the local programming electronic device are further configured to: determine the static persistent state threshold based on clinician characteristics, the patient characteristics, the medical device characteristics, or the monitoring characteristics obtained (automatically determining time threshold based on, e.g., system capacity and speed, i.e., medical device characteristics, Volpe, ¶[0159]); and update the static persistent state threshold based on the determining (configuring, i.e., updating, time threshold, Volpe, ¶[0159]).
Regarding claim 14, Volpe and Friedli disclosed the communication system wherein the monitoring characteristic is related to connectivity between the remote electronic device and the local programming electronic device (monitoring operational state of communication module, i.e., connectivity, Volpe, ¶[0149]).
Regarding claim 16, Volpe and Friedli disclosed the communication system wherein the dynamic session is a programming session (updating, i.e., programming, medical device, Volpe, ¶[0126]).
Regarding claim 17, Volpe and Friedli disclosed the communication system wherein the one or more processors of the local programming electronic device are further configured to: revert the medical device to a previous configuration in response to termination of the dynamic session so that the medical device can provide a treatment to the patient (canceling, i.e., reverting, software update, Volpe, ¶[0159]).
Regarding claim 19, Volpe disclosed the method as detailed above. Volpe did not disclose the method further comprising: monitoring at least one of patient characteristics, medical device characteristics, or monitoring characteristics during the dynamic session; determining a dynamic threshold based on the patient characteristics, the medical device characteristics, or the monitoring characteristics; determining whether the dynamic threshold is exceeded during the dynamic session; and terminating the dynamic session when the dynamic threshold is exceeded.
Friedli disclosed:
monitoring at least one of patient characteristics, medical device characteristics, or monitoring characteristics during the dynamic session (monitoring laboratory values of a patient, i.e., patient/medical device/monitoring characteristics, ¶[0094]); determining a dynamic threshold based on the patient characteristics, the medical device characteristics, or the monitoring characteristics (determining control parameter value, i.e., dynamic threshold, based on physiological parameter, i.e., patient characteristics, ¶[0103]); determining whether the dynamic threshold is exceeded during the dynamic session (determining parameters are outside predefined ranges, i.e., exceed a dynamic threshold, ¶[0094]-[0095], [0098]); and terminating the dynamic session when the dynamic threshold is exceeded (interrupting, i.e., terminating, execution of medical app, i.e., dynamic session, in response, ¶[0099], [0100], [0110]).
The combination of references is made under the same rationale as claim 10 above.
Regarding claim 20, Volpe and Friedli disclosed the method wherein determining the static persistent state threshold includes at least one of 1) receiving a manual input from a remote user of the remote electronic device or 2) determining the static persistent state threshold based on patient characteristics, clinician characteristics; medical device characteristics, or monitoring characteristics (automatically determining time threshold based on, e.g., system capacity and speed, i.e., medical device characteristics, Volpe, ¶[0159]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Volpe (U.S. Pat. App. Pub. 2016/0253471) and Friedli (U.S. Pat. App. Pub. 2017/0290980) as applied to claim 1 above, and further in view of Galarneau et al. (U.S. Pat. App. Pub. 2022/0062646), hereinafter Galarneau.
Regarding claim 8, Volpe and Friedli disclosed the communication system as detailed above. Volpe and Friedli did not disclose the system wherein the static persistent state threshold is less than five seconds.
Galarneau disclosed:
wherein the static persistent state threshold is less than five seconds (pacemaker monitoring metrics using predetermined threshold time interval, i.e., static persistent state threshold, of two, three, or four seconds, i.e., less than five seconds, ¶[0263]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Volpe and Friedli wherein the static persistent state threshold is less than five second as claimed, because doing so would have been obvious to try (choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Volpe (U.S. Pat. App. Pub. 2016/0253471) and Friedli (U.S. Pat. App. Pub. 2017/0290980) as applied to claim 10 above, and further in view of Bevan et al. (U.S. Pat. App. Pub. 2010/0125174), hereafter Bevan.
Regarding claim 15, Volpe and Friedli disclosed the communication system as detailed above. Volpe and Friedli did not disclose the system wherein the persistent action includes pressing an input button.
Bevan disclosed:
wherein the persistent action includes pressing an input button (programming changes by clicking buttons via server’s mouse or keyboard, ¶[0023]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Volpe and Friedli wherein the persistent action includes pressing an input button as claimed, because monitoring such actions would have protected against erroneous treatments (¶[0022]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH R MANIWANG whose telephone number is (571)270-7257. The examiner can normally be reached 8:30AM - 4:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wing F Chan can be reached at (571) 272-7493. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH R MANIWANG/Primary Examiner, Art Unit 2453
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