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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is directed to triggering “an ultrasound measurement…based on detection of the onset of the arrhythmia condition”. It is not clear what is meant by “ultrasound measurement” as it’s not clear if the claim is directed to triggering an “ultrasound image” based on the detection of arrhythmia. It is suggested claim language provide further clarity with respect to the language “ultrasound measurement”. The dependent claims do not provide additional clarity and therefore stand rejected under 112(b).
Claim 7 is directed to “transmitting instruction for an external device to being monitoring the cardiac episode via a sensor of the external device” where the comprises “an ultrasound sensor” (claim 12). However, similar to claim 1, the language does not provide clarity with respect to the type of “instruction” and type of “monitoring” in terms of triggering an “ultrasound image” based on detection of the cardiac episode. The dependent claims do not provide additional clarity and therefore stand rejected under 112(b).
Claim 13 is also directed to “utilize the sensor device to produce a measurement of the cardiac event” where the sensor device comprises “an ultrasound array” (claim 15). However, similar to claims 1 and 7, the language does not provide clarity with respect to the type of “measurement of the cardiac event” in terms of triggering an “ultrasound image” based on detection of the cardiac episode. The dependent claims do not provide additional clarity and therefore stand rejected under 112(b).
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(s) 1-3, and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hakki et al. (10821281).
With respect to claim 1, Hakki et al. teach of an apparatus comprising a processor 134 (col. 18, lines 40-50, fig. 2B), a cardiac sensor 150A-J (col. 18 lines 40-50), and an ultrasound sensor 154, 156, 166, 168 (col. 18 lines 40-50), wherein the processor is configured to detect an onset of arrhythmia condition using the cardiac sensor and trigger an ultrasound measurement using the sensor based on detection of the onset of the arrhythmia condition using the cardiac sensor (fig. 6, col. 22 lines 37-55) or the continuous monitoring of the electrical signals receive from the sensor and if the monitoring results in detection of life-threatening arrhythmia, the motion sensing signals are analyzed provided by the ultrasound sensor and blood flow sensing signals as well as body posture signal and a control signal is delivered to the therapy module 214.
With respect to claim 2, Hakki et al. teach of the cardiac sensor to comprise a cardiac electrogram sensor 150A-J (col. 18 lines 40-50).
With respect to claim 3, Hakki et al. teach of the ultrasound measurement to comprise blood flow measurement (col. 18 lines 40-50).
With respect to claim 5, Hakki et al. teach of atrial fibrillation (col. 23 lines 48-50, col. 24 lines 1-8).
Hakki et al. do not teach of all the claim elements in a single embodiment. It would have therefore been obvious to one of ordinary skill in the art to combine the elements from the various embodiments to continuously monitor patient’s cardiac condition, the therapy, and effectively diagnose a life-threatening cardiac situation.
Claim(s) 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hakki et al. in view of Chakravarthy et al. Hakki et al. do not teach of a patch or wearable device. In a similar field of endeavor Chakravarthy et al. teach of a medical device system comprising an implantable medical device 10 [fig. 1, 0029] comprising a plurality of electrodes 16A/16B configured to detect a cardiac electrical signal of a patient [0047], communication circuitry 54 configured to communicate with at least one other device [0047, 0050, fig. 2], and processing circuity configured to identify a cardiac episode in the cardiac electrical signal of the patient [0047] and transmit an instruction for an external device 12 to begin monitoring the cardiac episode via a sensor of the external device [0047, 0049]. Chakravarthy et al. also teach of the apparatus comprising a wearable device or patch [0056]. Hakki et al. teach of conducting ultrasound measurement by a microprocessor 134 (col. 22 lines 37-55) which would result in power increase and therefore necessarily a decrease when not in use but does not explicitly teach of the processor configured to cease using the ultrasound sensor whereby the power consumption on the battery is decreased. Chakravarthy et al. teach of reducing the power consumption and improving battery life [0044]. It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Chakravarthy et al. to modify Hakki et al. to provide increased accuracy in the detection and classification of arrhythmia in a patient while reducing power usage and improving battery life of the implantable medical device [Chakravarthy, 0044, 0048].
Claim(s) 7-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chakravarthy et al. (2020/0352466).
With respect to claim 7, Chakravarthy et al. teach of a medical device system comprising an implantable medical device 10 [fig. 1, 0029] comprising a plurality of electrodes 16A/16B configured to detect a cardiac electrical signal of a patient [0047], communication circuitry 54 configured to communicate with at least one other device [0047, 0050, fig. 2], and processing circuity configured to identify a cardiac episode in the cardiac electrical signal of the patient [0047] and transmit an instruction for an external device 12 to begin monitoring the cardiac episode via a sensor of the external device [0047, 0049].
With respect claims 8 and 9, Chakaravarthy et al. teach of the IMD to comprise the processing circuitry 50 configured to transmit the instruction via the communication circuitry directly to the external device [fig. 2, 0035, 0048].
With respect to claims 10 and 11, Chakravarthy et al. teach of the cardiac episode to be an arrythmia episode or an atrial fibrillation episode [0055].
Chakravarthy et al. do not teach of all the claimed elements in a single embodiment. It would have therefore been obvious to combine the elements from the various embodiments to effectively detect and classify cardiac arrhythmia in a patient .
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chakravarthy et al. in view of Hakki et al. (10821281). Chakravarthy et al. teach of different external sensors [0059] but do not explicitly teach of an ultrasound sensor. In a similar field of endeavor Hakki et al. teach of an implantable medical device to detect onset of arrhythmia condition using a cardiac sensor that includes an ultrasound sensor (col. 18 lines 40-50). It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Hakki et al. to provide an alternative sensing device to effectively monitor signals from sensors and transmit patient data from the sensors to an external device.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chakravarthy et al. Chakravarthy et al. teach of a sensor patch (fig. 2, 0031) comprising a sensor device (fig. 2), a power supply [0028, 0044], and a processor 50 configured to receive an indication that a cardiac sensor has detected a cardiac event in a patient [0041], utilize the sensor device to produce a measurement of the cardiac event whereby a power draw on the power supply is increased [0041, 0044, 0048] and cause utilization of the sensor device after the measurement of the cardiac event is produced whereby a power draw on the power supply is decreased [0041, 0044, 0048] and therefore reducing the power consumption and improving battery life [0044]. Chakravarthy et al. do not teach of all the claimed elements in a single embodiment. It would have therefore been obvious to combine the elements from the various embodiments to effectively detect and classify cardiac arrhythmia in a patient.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chakravarthy et al. in view of Hakki et al. Chakravarthy et al. teach of alternate external sensors as part of the patch or wearable device but do not explicitly teach of an ultrasound array sensor external to the sensor patch. In a similar field of endeavor Hakki et al. teach of an implantable medical device to detect onset of arrhythmia condition using a cardiac sensor that includes an ultrasound sensor array (col. 18 lines 40-50). It would have therefore been obvious to one of ordinary skill in the art to use the teaching by Hakki et al. to provide an alternative sensing device to effectively monitor signals from sensors and transmit patient data from the sensors to an external device.
Other relevant prior art:
Wang et al. (2016/0220225):
Directed to an arrhythmia detection device with monitoring probe attached to as subject with display of ECG parameters and an ultrasound probe attached onto the body surface with an imaging unit coupled to the probe with an arrhythmia triggering unit which triggers the ultrasound imaging unit to scan the heart of the subject when the monitoring unit detects an arrhythmia [0015].
Amagi et al. (2023/0125118):
“A second embodiment differs in that an imaging device is activated based on ultrasonic imaging data, and optical imaging data is acquired. For example, if an anomaly occurs in a subject in a housing unit, such as arrhythmia, it cannot be recognized in an optical image, and thus the anomaly in the subject can be found by detecting the anomaly based on the ultrasonic scanning data. Arrhythmia can also be recognized by attaching an electrode of an electrocardiogram examination apparatus to the subject and acquiring an electrocardiogram (ECG) waveform, but the electrode needs to be brought into contact with the subject and hygiene risks exist in the extrauterine environment system. Ultrasonic scanning has an advantage of being able to detect an anomaly in the subject, such as arrhythmia, without contact” [0077].
Conclusion
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BR
/BAISAKHI ROY/Primary Examiner, Art Unit 3797
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