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 .
Response to Arguments
Applicant’s arguments filed on 04/30/2026 have been fully considered but are not persuasive.
Applicant makes the following arguments:
The office action has not shown that Galarneau teaches making it easier to shock the patient when the fall.
The proposed combination of Degroot in view of Galarneau fundamentally changes the principle of operation of Degroot and renders it unsatisfactory for its intended purpose.
Regarding point (i), Galarneau discloses an analogous medical device that delivers a shock to a patient [0040] in response to detecting that a patient experienced a fall [0068]. Galarneau also discloses adjusting fall detection criteria to make the device more sensitive to fall detection [0075]. Examiner notes that modifying the system of Degroot to have the ability to detect a fall is supported by Galarneau, given that Galarneau discloses an analogous medical device that is capable of both therapy and fall detection. Examiner notes that the system of Degroot, prior to any modification with Galarneau, is capable of identifying and responding to two states: standing (high risk of fall make it easier to shock), and horizontal (lower immediate risk make it harder to shock). If one of ordinary skill in the art was to modify Degroot, they would do so in line with the principle of operation of Degroot. Therefore, if one was to modify Degroot to have the ability to detect a fall, as disclosed by Galarneau, they would modify Degroot to have a third state, that is, a state that responds to the patient’s fall. As indicated in the Non-Final Rejection, one of ordinary skill in the art would be motivated to make it easier to shock a patient when they fall because a fall may indicate that a patient is in an urgent state and relaxing the criteria would ensure that the patient receives a quick response.
Regarding point (ii), Examiner respectfully disagrees. As described above, the proposed combination is made such that it follows the fundamental principles of Degroot. Additionally, Examiner notes that such a modification does not render Degroot unsatisfactory but rather provides an advantage of enabling the implantable device to identify and respond to an additional state, that is, a patient experiencing a fall.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4-8, 11, 14 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Degroot et al. (US 8,478,399) in view of Galarneau et al. (US 2020/0380840).
In re claim 1, Degroot discloses a medical device system comprising:
memory (col. 5, lines 65-67: “RAM” in microprocessor 142) configured to
store information relating to an occurrence of a cardiac event in a patient (col. 9, lines 31-33), and
at least one of
treatment rules (col. 4, lines 4-9: “programmed tiered-therapy menus”) for at least one of
delivering a shock to the patient (col. 4, lines 4-9: “CV/DF shock”) or
delivering anti-tachyarrhythmia pacing therapy to the patient in response to the occurrence of the cardiac event (col. 4, lines 4-9: “ATP therapies”), and
cardiac event determination criteria for determining that the cardiac event is a particular type of cardiac event (col. 5 lines 65- col. 6 line 1; col 6. lines 61 - col. 7 line 11: where the cardiac event determination criteria is the “number of intervals to detect (NID)”); and
processing circuitry (FIG. 3) configured to:
determine the occurrence of the cardiac event in the patient (FIG. 4: 205; col. 10, lines 48-51);
determine, based at least in part on at least one motion sensor signal (col. 5, lines 22-27: “accelerometer”),
a posture change (227; col. 11, lines 17-22);
determine that the cardiac event and the posture change of the patient are associated in time (250; col. 11, lines 19-25); and
wherein as part of determining that the cardiac event and the posture change are associated in time, the processing circuitry is configured to
determine that the posture change
occurred during the cardiac event (col. 10, lines 54-57; col. 10, lines 11-20: “marker channel” indicates how far into a tachyarrhythmia event the posture change occurred (see incorporated reference Markowitz (US 4,374,382) (FIG. 2; col. 3, lines 24-33)),
occurred within a first predetermined time period before the cardiac event, or
occurred within a second predetermined time period after the cardiac event; and
in response to determining that the cardiac event and the posture change of the patient are associated in time, modulate a response to the cardiac event (255; col. 11, lines 19-25)
wherein to modulate the response, the processing circuitry is configured to:
at least one of
override the treatment rules (230; col. 7, lines 36-40: “quicker therapy response”) or
relax the cardiac event determination criteria (230; col. 7 lines 22-25 and 36-40: “a lower NID”), and
deliver a shock to the patient or deliver anti- tachyarrhythmia pacing therapy (245) to the patient based on at least one of overriding the treatment rules or relaxing the cardiac event determination criteria (FIG. 4; apparent as ATP therapy is delivered (245) after the detection criteria is adjusted (230));
generate an indication (212) the indication comprising
information indicative of the cardiac event (col. 10 , lines 8-11; col. 10, lines 55-56;)
information indicative of posture change (col. 10 lines 16-17; col. 10, lines 54-55)
transmit the indication to one or more external devices (col. 10, lines 55-56: “transmission of the data to a programmer”)
Degroot does not discloses wherein the posture change is at least one of
a fall of the patient,
a slumping posture of the patient, or
a change from an upright posture to a non-upright posture of the patient;
Galarneau discloses an analogous medical device capable of delivering a shock to a patient [0040] in response to detecting that a fall of a patient (abstract) and a cardiac event are associated in time ([0068]: “…preceding and/or encompassing…”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Degroot, to make it easier to shock the patient when they fall, as disclosed by Galarneau. One would have been motivated to make this modification because a fall may indicate that a patient is in an urgent state and relaxing the criteria would ensure that the patient receives a quick response.
Accordingly, such a modification would enable Degroot to identify and respond to the following states: (i) standing (high risk of fall, make it easy to shock); (ii) just fell (likely urgent state, make it easy to shock); and (iii) horizontal (lower immediate risk, make it harder to shock).
In re claim 2, the proposed combination yields (all mapping directed to Degroot)
wherein the cardiac event comprises at least one of a tachyarrhythmia, a pause in heartbeat, myocardial infarction, or a stroke (col. 3, lines 46-48: “tachyarrhythmia”).
In re claim 4, the proposed combination yields (all mapping directed to Degroot)
wherein the cardiac event comprises a ventricular tachyarrhythmia (col. 6, lines 37-40: algorithms can detect “ventricular tachycardia”) and as a part of modulating the response to a cardiac event, the processing circuitry is configured to override treatment rules (230; col. 7, lines 36-40: “quicker therapy response”)
wherein delivering treatment to the patient comprises, based on overriding the treatment rules, delivering a shock to the patient or delivering anti-tachyarrhythmia pacing therapy to the patient (col. 7, lines 36-40: “therapy response”, which as shown in FIG. 4 can involve delivering ATP therapy (245)).
In re claim 5, the proposed combination yields (all mapping directed to Degroot)
wherein the cardiac event comprises ventricular tachyarrhythmia (col. 6, lines 37-40: algorithms can detect “ventricular tachycardia”), and
wherein the processing circuitry is further configured to
in response to the at least one of a fall of the patient, the slumping posture of the patient or the change from an upright posture to a non-upright posture of the patient, relax ventricular tachyarrhythmia determination criteria (col. 7, lines 22-24; col. 7, lines 36-40: where lowering using a lower “NID” allows for a quicker therapy response; Examiner notes this occurs at FIG. 4: 230); and
determine that the cardiac event meets or surpasses the relaxed ventricular tachyarrhythmia determination criteria (apparent as processing circuitry tracks the “NID”; col. 6, line 67- col. 7 line 11),
wherein delivering treatment to the patient comprises delivering a shock to the patient based on determining that the cardiac event meets or surpasses the relaxed ventricular tachyarrhythmia determination criteria (col. 7, lines 36-40: “therapy response”, which as shown in FIG. 4 can involve delivering ATP therapy (245)).
In re claim 6, the proposed combination yields wherein the processing circuitry is further configured to (all mapping directed to Degroot):
prior to delivering the shock to the patient, determine that the patient has stopped moving for a predetermined period of time (FIG. 3: 178; inherent since device is controlled by pacing/device timing circuitry) or that the patient is in a lying posture for the predetermined period of time (FIG. 4: 227; Response “no” to block 227 would indicate that the patient still remains in a non-upright position.); and
in response to determining that the patient has stopped moving for the predetermined period of time or that the patient is in the lying posture for the predetermined period of time, *deliver the shock to the patient (225).
*It is noted that an overriding of the shock criteria (229) is required to deliver a shock to a
patient (255) that remains in a non-upright position. However, this limitation is still met as a shock is
delivered to a patient in a non-upright position after a predetermined period of time.
In re claim 7, the proposed combination yields (all mapping directed to Degroot)
wherein the cardiac event comprises an atrial tachyarrhythmia (col. 6, lines 40-41; “atrial fibrillation” is a type of atrial tachyarrhythmia) and
as part of modulating the response to the cardiac event, the processing circuitry is further configured to administer an anti-tachyarrhythmia pacing sooner than the medical device system would have administered the anti-tachyarrhythmia pacing therapy if the response was not modulated (col. 7, lines 36-40: *relaxing the cardiac determination criteria results in a “quicker detection of a tachycardia/fibrillation and subsequently a quicker therapy response”).
*Examiner notes that relaxing the cardiac determination criteria is part of modulating the response as stated in claim 1.
In re claim 8, the proposed combination yields (all mapping directed to Degroot)
wherein the cardiac event comprises atrial tachyarrhythmia (col. 6, lines 40-41: “atrial fibrillation” is a type of tachyarrhythmia) and
wherein the processing circuitry is further configured to:
relax atrial tachyarrhythmia onset detection criteria to create relaxed atrial tachyarrhythmia onset detection criteria in response to the at least one of a fall of the patient, the slumping posture of the patient, or the change from an upright posture to a non-upright posture of the patient (col. 7, lines 22-24; col. 7, lines 36-40: where lowering using a lower “NID” allows for a quicker therapy response); and
determine that the cardiac event meets or exceeds the relaxed atrial tachyarrhythmia onset detection criteria (apparent as processing circuitry tracks the “NID”; col. 6, line 67- col. 7 line 11).
In re claim 11, the proposed combination yields (all mapping directed to Degroot)
wherein the one or more external devices comprise at least one of a patient device, a caregiver device, a call center device, a nursing home device, a remote monitoring system, or an **emergency medical services device (col. 9, lines 59-61).
**As disclosed in Degroot, data is sent to external programmer for review by a patient’s
physician. As known by those in the art, the external programmer is considered an emergency medical
service device as it provides pre-hospital care to patients experiencing medical emergencies.
In re claim 14, the proposed combination yields (all mapping directed to Degroot)
wherein the cardiac event comprises a tachyarrhythmia (FIG. 4: 205 “tachycardia detection”), and
wherein the indication for output comprises information indicative of how far into the tachyarrhythmia the at least one of
the fall of the patient (col. 10, lines 54-57; col. 10, lines 11-20: “marker channel” indicates how far into a tachyarrhythmia event the posture change occurred (see incorporated reference Markowitz (US 4,374,382) (FIG. 2; col. 3, lines 24-33); Regarding the limitations “posture change” see modification above In re claim 1),
the slumping posture of a patient,
or the change from the upright posture to the non- upright posture of the patient occurred.
In re claim 19, see above (In re claim 1).
The proposed combination also yields
a method (Degroot: abstract)
In re claim 20, see above (In re claim 1)
The proposed combination also yields
Non-transitory computer readable storage media having stored thereon instructions (Degroot: col. 5, lines 65- col. 6 lines 1-2).
In re claim 21, regarding the limitation “wherein the predetermined period of time is between 10 and 15 seconds, inclusive” it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the predetermined period of time between 10 and 15 seconds, inclusive, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 In re Aller, 105 USPQ 233. MPEP 2144.05-II-A
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Degroot et al. (US 8,478,399), in view of Galarneau et al. (US 2020/0380840), in view of Volpe (US 2017/0258401).
In re claim 12, the proposed combination yields (all mapping directed to Degroot),
wherein the processing circuitry is further configured to:
determine, a first external device of the one or more external devices (col. 9, lines 59-61: “external programmer”); and
transmit the indication to the first external device (col. 10, lines 53-57).
The proposed combination does not yield,
prior to transmitting the indication to the one or more external devices, determine a living situation of the patient stored in the memory;
determine, based on the living situation of the patient, a first external device of the one or more external devices.
Volpe discloses a medical device that incudes a sensor to acquire data, a memory, and a processor coupled to the memory (abstract). As discussed in Volpe, the medical device stores information about a patients living situation ([0015]; [0069]:“street address, name of location”) and uses that information to identify an appropriate external device [0082]. Once the medical device has identified the appropriate external device, the processor begins sending notifications/information to the appropriate external device [0085, 0086, 0103]. Volpe specifies that the medical device can take various forms one being a cardiac monitor or wearable defibrillator [0059,0060].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processing circuitry of the proposed combination to a) store a patient’s living situation in the memory; b) prior to transmitting the indication to the one or more external devices, determine a living situation of the patient store in the memory; and c) determine, based on the living situation of the patient, a first external device of the one or more external devices, as taught by Volpe. One would have been motivated to make this modification because doing so would enable the medical device to tailor the information presented on the user interface, making sure information presented on the external device is relevant to caregivers/individuals associated with the patients living situation (Volpe, [0104]).
Claim 13 is rejected under 35 U.S.C. 193 as being unpatentable over Degroot et al. (US 8,478,399) in view of Galarneau et al. (US 2020/0380840) and further in view of Perschbacher et al. (US 2017/0251940).
In re claim 13, the proposed combination yields …and the indication for output further
comprises at least one of (all mapping directed to Galarneau unless stated otherwise)
• a) an indication of a first posture of interest prior to the cardiac event and an indication of a
second posture of interest after the cardiac event, or
• b) an indication of whether a fall occurred during the cardiac event ([0068]; cardiac episode
“encompassing” the detected fall can be stored in the fall data [0068], which is later transmitted
to the external device [0049])
The proposed combination does not yield
wherein the cardiac event comprises a pause in heartbeat.
Perschbacher discloses an analogous device capable of detecting a cardiac pause (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of the proposed combination to be able to detect a pause in heartbeat. One would have been motivated to make this modification because a pause in heartbeat is known in the art, and the result of the modification, i.e., monitoring/providing treatment for a pause in heartbeat, is reasonably predictable.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Degroot et al. (US 8,478,399) in view of Galarneau et al. (US 2020/0380840) in view of Fischell et al. (US 8,224,430).
In re claim 15, the proposed combination yields
and send the indication to an emergency medical services device (see above In re claim 11).
The proposed combination does not yield
wherein the cardiac event comprises a myocardial infarction wherein the processing circuity is further configured to:
monitor an ST segment of an electrocardiogram
determine that the ST segment is more than a predetermined threshold higher than an average of earlier ST segments;
Fischell discloses an analogous medical device capable of detecting a myocardial infarction (col. 15, lines 58-63). Additionally, Fischell discloses an ST detection technique that involves processing baseline ECG segments to calculate a threshold for myocardial infarction detection (col. 7, lines 43-46). Fischell further discloses the ability to automatically notify emergency medical services when a cardiac event is detected (col. 17, lines 15-20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the device taught by the proposed combination to include myocardial infarction as the cardiac event, as taught by Fischell. One would have been motivated to make this modification because timely treatment of a myocardial infraction is crucial to patient survival (Fischell: col. 1, lines 47-49).
In re claim 16, the proposed combination yields (all mapping directed to Degroot)
wherein the processing circuitry is further configured to in response to determining an event (FIG. 4 : 205 ; col. 10, lines 48-51), enable at least one of fall or posture detection (see modification In re claim 1)
The proposed combination does not disclose wherein the event is
determining that the ST segment is more than the predetermined threshold higher than the average of the earlier ST segments.
As previously stated, Fischell discloses an ST detection technique that involves processing
baseline ECG segments to calculate a threshold for myocardial infarction detection (col. 7, lines 43-46).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proposed combination to include the ability to determine that the ST segment is more than a predetermined threshold, as taught in Fischell. One would have been motivated to make this modification because shifts in a patients ST segment can indicate an acute myocardial infarction (Fischell: col. 1, lines 47-49), which if present would require immediate medical attention (Fischell: col. 1, lines 28-39).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Degroot et al. (US 8,478,399 in view of Galarneau et al. (US 2020/0380840), in view of Fischell et al. (US 8,224,430), and in view of Vogtmeier et al. (US 2024/0177850).
In re claim 17, Degroot does not disclose
wherein the processing circuitry is further configured to:
send a communication to a cellular phone of the patient; and
in response to not receiving a response from the patient via the cellular phone, send the indication to at least one of the one or more external devices.
Galarneau further discloses sending a communication to a patient’s smart phone [0032].
It would have been obvious to one of ordinary skill in the art before the effective filing date to
modify the medical device taught by Degroot to include the ability to send a communication to a smart
phone, as taught by Galarneau. One would have been motivated to make this modification because a
smart phone is a communication device, and the result of the modification (i.e., communicating
information to a patient) is reasonably predictable.
Galarneau does not disclose:
in response to not receiving a response from the patient via the cellular phone, send the indication to at least one of the one or more external devices.
Vogtmeier discloses a medical device that sends a communication to an external device ([0067]: “display”, “loudspeaker”) upon not receiving a response from the patient ([0060] : “assessing result is negative”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the medical device of the proposed combination to include the ability to send an indication to an external device upon not receiving response from a patient. One would have
been motivated to make this modification because not receiving a response from a patient could indicate that the patient is unresponsive. Sending the indication to an external device would help notify medical personal that the patient needs immediate attention (Vogtmeier, [0027]).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLIVIA WALKER whose telephone number is (571)272-7052. The examiner can normally be reached M-F: 7-4pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLIVIA WALKER/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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