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 .
Priority: The claim set presented on 03/26/2024 is accorded the priority date of 11/10/2017 according to the priority chain on the record.
Claim Status
As per applicant’s response received on 06/04/2026, claims 198-205 are pending; claims 1-197 have been cancelled, and claims 198, 200-202 and 204-205 have been amended.
Response to Amendment
The 35 USC 112(a) rejection to claim 203 is withdrawn in view of current claim amendment.
As for the 35 USC 102 rejections based on Park et al US 2016/0325107 A1, the Applicant’s arguments have been fully considered but are not moot in view of new grounds of rejections below.
Claim Interpretation
Regarding claims 200-201, these claims are directed to the recited “user interface” being configured to be controlled by “the patient” or “a person other than the person”; under broadest reasonable interpretation/BRI, the Examiner treats these limitations are intended use feature of the “user interface.” Note: a user interface can be used by anyone, unless there is a feature for identifying/authenticating specific approved users, but this is not positively recited in the claims.
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 192-202, 204 and 205 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. US 2016/0325107 A1 and in view of Cowan et al. US 2014/0043149 (hereinafter “Cowan”, previously cited).
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Regarding claim 198, Park teaches a defibrillator system (Figs. 1 and 9: wearable /patch-automatic defibrillator AED 100), comprising:
an external defibrillator (wearable/patch AED 100) comprising a housing (patch AED 210B-2 inherently has covering/membrane, interpreted as “housing” in the claim, see [0035-0036, 0042-0043]) and an energy storage module (batteries 250, 260) within the housing ([0042] batteries are embedded in the membrane of the patch AED), the energy storage module (250, 260) configured to store an electrical charge;
a mobile device (smart device 400) coupled with the external defibrillator (see Fig. 9 wireless communication between 210B-1 to 400 via wireless circuit 240);
a user interface (display 410 and defibrillation GUI 415) in the mobile device (400) configured to indicate a mode of operation of the defibrillator system (see [0087] “when a particular symptom of a heart problem is detected, an application may display a defibrillation GUI 415 on the display 410. As the defibrillation GUI 415 is touched or pressed by a user of the smart device 400, the application may generate…” also see [0109]. In here, Park explicitly teaches GUI 415 is indicative of a defibrillation mode. Park also implicitly teaches an ECG mode, because it is noted that AED 100 operates in either ECG sensing via ECG sensor chip 220, or in defibrillation mode via defibrillator circuit 235, see Fig. 9 Above);
a first electrode (common electrode 203a, 301a) configured to be coupled to the housing (see Fig. 9), and configured to be maintained on a body of a patient (electrodes are maintained as it is worn on the body, as shown in Fig. 1); and
a processor (CPU 230B, processor in 400) configured to:
receive a patient parameter via at least monitoring device (Fig.9: ECG sensor chip 220, and [0106] electrodes 203a and 301a detects ECG1 and ECG2 signals, ECG sensor chip 220 and associated processing (software) are taken to encompass “monitoring device” in this claim);
determine, from the received patient parameter, when the first shock criterion is met ([0110-0112] analyzes the heart function based on at least ECG signals, determine whether heart function abnormality exists, and generate a first control signal); and
cause, based in the indicated mode of operation on the user interface ([0087] “the defibrillation GUI 415 is touched or pressed by a user of the smart device 400, the application may generate a first control signal CTR1 (S260), and transmit the first control signal CTR1 to the wireless circuit 240 through a communication modem (S270)” this first control signal then triggers a second control signal to activate the defibrillator circuit 235 according to [0088-0089, 0111-0112]; CPU230B receives the first control signal and activate a second control signal to activate the defibrillator circuit 235 to provide an electric shock through electrodes 203a, 301a.) and a determination that the first shock criterion being met, at least some of the stored electrical charge to be discharged via the first electrode through the patient so as to deliver a first shock to the patient via the first electrode. ([0089-0090] defibrillator circuitry 235 may automatically control discharging of the second battery 260 so as to provide the patient with an electric shock in response to a control signal from the CPU 230B. Also see [0093] “The common electrode 203a serves as both a first ECG electrode and first defibrillation electrode, and the second common electrode 301a serves as both a second ECG electrode and second defibrillation electrode”, the same electrodes are used for ECG sensing and defibrillation.)
In an alternative rejection with regard to the user interface, Cowan, another prior art reference in the analogous art of mobile communication device and app for wearable defibrillator system (see Abstract), teaches a mobile communication device 110, e.g. smart phone, in communication with a wearable defibrillation system 200 for displaying a user interface 370 so as to allow a user to view data and to control the wearable defibrillation system via a series of controls/inputs ([0062]). With regard to the wearable defibrillation system, Cowan teaches that it operates in various different modes, including: monitoring mode (see [0073: middle of paragraph] monitoring various parameters), disease management and patient care ([0075]), stand-by mode, airplane mode ([0104]), video/communication mode ([0143, 0160]) and by inherency, defibrillation mode since it is a defibrillation system ([0044, 0067-0068, 0070] to guide/administer defibrillation shock). In view of this, it would have been obvious to modify Park’s smart device 400, associated app and GUI to include and display the various modes of operation in view of Cowan, the motivation for doing so is because both Park and Cowan are similar in its system setup of using smart mobile devices capable to selectively change between at least defibrillation and monitoring modes (Park: Fig. 9, and Cowan: as discussed immediately above), and also providing the GUI with input/keys to allow the user to select between various modes is simply common sense and necessary for normal operation of the described systems (Park: [0087, 0109]; Cowan: [0062]).
Regarding claim 199, Park modified discloses the defibrillator system of claim 198, wherein:
the processor (230B) is configured to be controlled by the user interface of the mobile device. (See Park: Fig. 6 and [0108-0110] application on smart device 400 analyzes the heart data received from patch AED’s CPU 230B, determines whether a heart function abnormality exists, and automatically generate a first control signal CTR 1, that is received by CPU 230B, so as to activate the defibrillator circuit 235.)
Regarding claim 200, Park discloses the defibrillator system of claim 198, wherein:
the user interface (display 410 and GUI 415) is further configured to be controlled by the patient to cause the therapy to be delivered to the patient. (Park: [0087] “…the defibrillation GUI 415 is touched or pressed by a user of the smart device 400, the application may generate a first control signal CTR1 (S260)…” this first control signal then triggers a second control signal to activate the defibrillator circuit 235 according to [0088-0089, 0111-0112]; CPU230B receives the first control signal and activate a second control signal to activate the defibrillator circuit 235 to provide an electric shock through electrodes 203a, 301a. Alternatively, see modification to claim 198 above, Cowan teaches guiding/administering defibrillation shock in [0044, 0067-0068, 0070])
Regarding claim 201, Park modified discloses the defibrillator system of claim 198, wherein:
the user interface (display 410 and GUI 415) is configured to be controlled by a person other than the patient to cause the therapy to be delivered to the patient. (See rejection to claim 200 above, Park: GUI 415 is button displayed on a display device 410, it can be pressed by anyone to trigger its intended function. Alternatively, see modification to claim 198, Cowan teaches guiding/administering defibrillation shock in [0044, 0067-0068, 0070])
Regarding claim 202, Park modified discloses the defibrillator system of claim 198, wherein: the user interface (display 410 and GUI 415) is configured to provide an alert that delivery of the shock is imminent. (Park: [0077] generating audible alarm 247 when the control signal for defibrillation is generated/received; [0123] providing warning. Alternatively, see rejection to claim 198, Cowan teaches displaying warning in [0075])
Regarding claim 204, Park modified discloses the defibrillator system of claim 198, wherein: the user interface (display 410 and GUI 415) is further configured to establish a communication link (network 1:501) with a remote server to transmit the patient parameter to the remote server. (See Park: [0117] and Fig. 12, smart device 400 transmit patient data to remote device/server 510. Also see Figs. 14-17, communication with health care server 820, 915. Alternatively, see modification to claim 198 above, Cowan teaches communication mode in [0160])
Regarding claim 205, Park modified discloses the defibrillator system of claim 198, wherein: the user interface (interface on smart device 400) is configured to contact a remote assistance center. (See Park: [0114] and Fig.12 smart device 400 transmit patient data to emergency service 600. Also see Figs. 14-17, communication with medical institution/publish health center etc. 840. Alternatively, see modification to claim 198 above, Cowan teaches communication mode in [0160])
Claim 203 is rejected under 35 U.S.C. 103 as being unpatentable over Park and Cowan as applied to claim 198 above, and further in view of Jorgenson US 2017/0367591 A1.
Regarding claim 203, Park modified discloses the defibrillator system of claim 198, comprising an additional sensor 245, i.e. an accelerometer or gyro sensor for detecting motion or falling event (Park: [0076, 0099]), Park also discloses that the detected motion events are considered along with heart function data when determining whether defibrillation should be initiated ([0059, 0099-0100]). Park and Cowan do not disclose, wherein: the patient parameter comprises patient breathing information.
Jorgenson, another prior art reference in the analogous art, discloses a wearable cardioverter defibrillator (WCD) comprising a set of therapeutic electrode for placement on a subject to provide electric shock, the WCD further comprising sensing electrodes and additional physiological sensors (see Abstract and Figs. 1A-1B), including an accelerometer sensor 20 for detecting respiration data ([0012] “The accelerometer sensor is configured to monitor the change in health parameter as a function of respiration and a lack of breathing”). When ECG signals indicate heart abnormality and it is determined that a monitored person is not breathing, defibrillation is initiated ([0032]). It would have been obvious to a person of ordinary skill in the art at the time of invention to further modify Park’s accelerometer such that it is used to detect respiration rate or breathing, in view of Jorgenson; the motivation for doing so is because Park’s AED already comprises a accelerometer, and using detected motion to determine breathing rate is a factor that can be considered in addition to ECG signals when determining defibrillation is needed. (Jorgenson: [0012, 0032])
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY X JIAN whose telephone number is (571)270-7374. The examiner can normally be reached M-F 8:00-4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHIRLEY X JIAN/Primary Examiner, Art Unit 3792
August 20, 2026
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