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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 203 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 198, line 9 recites “receives a patient parameter via the first electrode.” Claim 203 depends from claim 198; thus, when considered as a whole, claim 203 requires “the first electrode” to receive “the patient parameter… patient breathing information.” There is no explicit teaching or support in the Applicant’s Specification, that an electrode is capable of receiving breathing information, as recited in claim 203. Specification [0053] teaches one or more sensors or transducers capable of detecting physiological parameter; [0102, 0106] positively discloses “ECG signals”; [0165] discloses providing one or more sensors to detect breathing sounds; and finally [0166] discusses monitored physiological parameter trends including respiratory function. It is the Examiner understanding that an electrode is capable of detecting electrical signal but not respiration/breathing information; an additional physiological sensor is required for detecting ‘patient breathing information’ as recited.
The Applicant is required to amend claim 203, or cancel any recited claim matter that is not supported in the Disclosure.
Claim Interpretation
To claim 1, the claim feature “determine, from the received patient parameter, when the first shock criterion is met; and cause, response to the first shock criterion being met, at least some of the stored electrical charge to be discharged…” invokes contingent limitation interpretation according to the MPEP 2111.04 II.
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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 198-202, 204 and 205 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. US 2016/0325107 A1 (hereinafter “Park”).
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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 in the mobile device (all smart devices inherently have a user interface, see Fig. 9 and [0107] 400 has application for displaying heart rate 411 and ECG 413);
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 the first electrode (Fig.9: ECG sensor chip 220, and [0106] electrodes 203a and 301a detects ECG1 and ECG2 signals);
cause a shock to be delivered responsive to a first shock criterion being met (Fig. 9: defibrillator circuit235 and [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);
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, responsive to 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. ([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. 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.)
Regarding claim 199, Park 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 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 (interface on smart device 400) is configured to be controlled by the patient to cause the shock to be delivered to the patient. (This limitation is interpreted as intended use of the “user device.” See [0084] smart device 400 can receive a command (from any user of the smart device), this command can include control signal to initiate defibrillation at the patch AED)
Regarding claim 201, Park discloses the defibrillator system of claim 198, wherein:
the user interface (interface on smart device 400) is configured to be controlled by a person other than the patient to cause the shock to be delivered to the patient. (This limitation is interpreted as intended use of the “user device.” See [0084] smart device 400 can receive a command (from any user of the smart device), this command can include control signal to initiate defibrillation at the patch AED. Also see Figs. 14-16, the smart device is in communication with physicians over a wireless network, and thus it is able to receive commands from said connected physicians to generate a first control signals to initiate defibrillation at the patient’s patch AED)
Regarding claim 202, Park discloses the defibrillator system of claim 198, wherein: the user interface (interface on smart device 400) is configured to provide an alert that delivery of the shock is imminent. ([0077] generating audible alarm 247 when the control signal for defibrillation is generated/received; [0123] providing warning)
Regarding claim 204, Park discloses the defibrillator system of claim 198, wherein: the user interface (interface on smart device 400) is configured to establish a communication link (network 1:501) with a remote server to transmit the patient parameter to the remote server. (See [0117] and Fig. 12, smart device 400 transmit patient data to remote device/server 510. Alternatively, see Figs. 14-17, communication with health care server 820, 915)
Regarding claim 205, Park 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 [0114] and Fig.12 smart device 400 transmit patient data to emergency service 600. Alternatively, see Figs. 14-17, communication with medical institution/publish health center etc. 840)
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.
Claim 203 is rejected under 35 U.S.C. 103 as being unpatentable over Park as applied to claim 198 above, and in view of Jorgenson US 2017/0367591 A1.
Regarding claim 203, Park 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 ([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 does 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 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Silver et al. US 2017/0106183 discloses a wearable resuscitation device that comprises an electrode assembly for detecting ECG signals and delivering electric shock; see Figs. 1A and 1B and [0077]
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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/SHIRLEY X JIAN/ Primary Examiner, Art Unit 3792
January 29, 2026