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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/18/2025 has been entered.
Claim status
This action is in response to applicant filed on 09/18/2025.
Claims 1 has been amended.
Claims 10-11 have been cancelled.
Claim 25 is new.
Claims 1-9, 12-25 are pending for examination.
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.
Claim(s) 1, 2-6, 9-11, 15, 19-20 & 22-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Innovations (WO 2014/150115).
Regarding claim 1: Innovations disclose a computing device communicatively coupled to a medical device (see title, abstract, par.[0045] "processor 100", par.[0046] "cardiac activity...temperature" - as examples of vitals of the subject -, par.[00167] - storage of events or raw data may also be performed on remote storage, in the case "communicatively" was to be understood as wireless. See also claims 1-4,8 and fig.1-3,8. The device may also be implanted as disclosed in par.[0079] and comprise an ECG sensor) of a non-human subject (see par.[0002] and claim 1 "animal") comprising:
processing circuitry(see fig.1, e.g. the processing part characterized by processor(s) 100 in combination with par.[0045]); and
a memory comprising instructions that, when executed by the processing circuitry, cause the processing circuitry to (see fig.1, items 102-104 and claim 1 - explicit):
receive monitored physiological data from the medical device configured to monitor the physiological data of the non-human subject, the monitored physiological data including one or more of an electrocardiogram (EKG), an electroencephalogram (EEG), an electromyogram (EMG), a heart rate, a heart sound, a temperature, an impedance, a respiration rate, a glucose level, a focal blood flow, posture, and tissue oxygenation of the non-human subject (see e.g. par.[0046] - the different types of sensors - "UWB" to monitor heart rate or temperature and par.[0049] for example of reading "outside normal range" for any sensor A-F, thus vitals or environment data. Further, as understood from par.[0003] of the description of the present application, "activity" is considered as a vital and defined as measurements from an accelerometer in its par.[0119]);
determine that the medical device indicates that the monitored physiological data is indicative of a health event triggering an upload of at least a portion of the monitored physiological data to a remote computing system configured to store historical data for the non-human subject (see par.[0048-0049], the passage reciting "In a second example, processor 100 only stores indications that a sensor has provided a reading outside of a normal range. The normal range may be set by the current profile and/or operating mode and may include one or more thresholds for each sensor signal." - if the data satisfy the condition "out of range", for any sensor type A-F, the data are then transferred/stored); and
in response to the determination, generate, for communication to the remote computing system, output data comprising an indication of a health event the at least a portion of the monitored physiological data (par [0085]-[0087]).
Regarding claim 2: Innovations disclose the computing device of claim 1 further comprising within a housing affixed to the non-human subject via at least one of a harness or a collar, wherein the processing circuitry and the memory are contained within the housing.(Fig. 4, 5, 7)
Regarding claim 3: Innovations disclose the computing device of claim 1, wherein the remote computing system is configured to store the output data as historical data for the non-human subject. (see par.[00181], [00182])).
Regarding claim 4: Innovations disclose the computing device of claim 1, wherein the instructions further cause the processing circuitry to: determine that, for a heart of the non-human subject, the medical device indicates an occurrence of an episode of an arrhythmia or another cardiac dysfunction. (para [0046]: monitors cardiac activity and para [0087]: In general, the following lists typical inferences that may be reported to owner.… the animal's heart rate variability is abnormal).
Regarding claim 5: Innovations disclose the computing device of claim 1, wherein the instructions further cause the processing circuitry to: determine at least one of a heart rate measurement exceeds a first threshold, an impedance measurement exceeds a second threshold, a temperature measurement exceeds a third threshold, a change in temperature per unit of time exceeds a fourth threshold, accelerometer data satisfies a fifth threshold, a respiration rate exceeds a sixth threshold, or an oxygen saturation satisfies a seventh threshold. (see claim 1, the threshold exceeded by the accelerometer may be considered as corresponding to "abnormal" values, the term abnormal having no well recognize meaning, See also the sensors disclosed in par.[0099]).
Regarding claim 6: Innovations disclose the computing device of claim 1, wherein the memory further comprises instructions that, when executed by the processing circuitry, cause the processing circuitry to: communicate, to a user device, a message comprising the output data; and receive, from the user device, a reply comprising a control directive to initiate an action. (see par.[00167], [00179] and fig.22, step 2212), D2 (see fig.22).
Regarding claim 9: Innovations disclose the computing device of claim 1, further comprising: sensing circuitry coupled to one or more sensors and configured to generate the monitored physiological data; (see fig.8, the system is performing the steps in a loop, therefore a "second" portion of the physiological signal is also transferred later in time).
Regarding claim 15: Innovations disclose the computing device of claim 1, wherein to receive the monitored physiological data, the processing circuitry is configured to: retrieve at least a portion of the monitored physiological data in accordance with a schedule established by the remote monitoring system or in accordance with an information request received from the remote monitoring system. (see par.[0076])
Regarding claim 19: The same reasoning applies to the subject-matter of the independent claim 19, which therefore is also considered not new, as in Innovations, the threshold explicitly relates to accelerometer data (see claim 1 of Innovations). Further, it is to be noticed that as the threshold of the physiological data in claim 19 is related to minimum acceleration, the physiological data itself can exclusively be related to accelerometer data, which are, consequently, the only data to be generated for output. Any other type of physiological signal is merely sensed. Therefore, it also appear that claim 19 is unclear as the essential feature being the accelerometer as a sensor, itself, is absent from the claim.
Regarding claim 20: Innovations disclose the medical device of claim 19, wherein to determine that the physiological data is indicative of a health event triggering the upload, the instructions cause the processing circuitry to: in response to a determination that the sensed physiological data is indicative of a cardiac episode for the non-human subject, generate, for communication to the computing device, output data comprising the cardiac episode and at least a portion of the sensed physiological data (see par.[0087]-[0093]).
Regarding claim 22: Innovations disclose the medical device of claim 19, further comprising an implantable medical device or a wearable medical device (see par.[0079] for the implanted aspect).
Regarding claim 23: The same reasoning of claim 1 applies to the subject-matter of the independent method claim 23, corresponding to Innovations.
Regarding claim 24: Innovations disclose the method of claim 23, wherein the output data further comprises: generating, by sensing circuitry coupled to one or more sensors, the monitored physiological data of the non-human subject (see e.g. par.[0046] - the different types of sensors - "UWB" to monitor heart rate or temperature and par.[0049] for example of reading "outside normal range" for any sensor A-F, thus vitals or environment data. Further, as understood from par.[0003] of the description of the present application, "activity" is considered as a vital and defined as measurements from an accelerometer in its par.[0119]).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Innovations (WO 2014/150115).
Regarding claim 7: Innovations disclose the computing device of claim 1, but does not explicitly disclose wherein the memory further comprises instructions that, when executed by the processing circuitry, cause the processing circuitry to: communicate, to a user device, an alert of a health event for the non-human subject; and receive, from the user device, a reply comprising a confirmation or a termination of the health event. However it does disclose control command sent by a user to a device to e.g. data transfer), and the reprogramming of the device based on said command (Fig. 22, step 2212). Therefore, Before the effective filing date, it would have been obvious to the one of the ordinary skill in the art to modify the system of Innovations to allow user command (i.e. reply) to reprogram the device to confirm or terminate the health event in view of the teachings of Innovation. The motivation is to allow the user to stop the alert once the user is notify hence minimizing unnecessary alerts.
Regarding claim 8: The same reasoning applies to the subject-matter of claim 8, corresponding to Innovations
Claim(s) 12-14, 16-18 & 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Innovations (WO 2014/150115) in view of Goldfain (US 2016/0174099).
Regarding claim 12: Innovations disclose the computing device of claim 9, but does not explicitly disclose wherein the instructions further cause the processing circuitry to: based on the sensed physiological data or the communication circuitry, detect a disconnection with the medical device.
In analogous art regarding medical devices of non huma subject, Goldfain disclose that "opportunistic syncing" which takes into account connections/disconnections with the network/communication channel (para [0065]).
Before the effective filing date, it would have been obvious to the one of the ordinary skill in the art to include the feature of wherein the instructions further cause the processing circuitry to: based on the sensed physiological data or the communication circuitry, detect a disconnection with the medical device, as disclose by Goldfain, to the device of Innovations. The motivations is to save power by disconnecting the device when is not transmitting.
Regarding claim 13: Innovations disclose the computing device of claim 9, but does not explicitly disclose wherein the instructions further cause the processing circuitry to: in response to detecting network access from signal data of a network device that is communicatively coupled to the remote computing system, generate, for communication to the network device, the output data.
In analogous art regarding medical devices of non huma subject, Goldfain disclose that in response to detecting network access from signal data of a network device that is communicatively coupled to the remote computing system, generate, for communication to the network device, the output data (para [0065]-[0069]).
Before the effective filing date, it would have been obvious to the one of the ordinary skill in the art to include the feature of in response to detecting network access from signal data of a network device that is communicatively coupled to the remote computing system, generate, for communication to the network device, the output, as disclose by Goldfain, to the device of Innovations. The motivations is to save power by disconnecting the device when is not transmitting.
Regarding claim 14: Innovations disclose the computing device of claim 9, but does not explicitly disclose wherein the instructions further cause the processing circuitry to: in response to an insufficient resource capacity, generate, for communication to a network device, the output data.
In analogous art regarding medical devices of non huma subject, Goldfain disclose that in response to an insufficient resource capacity (for example, reduced battery capacity), generate, for communication to a network device, the output data (para [0065]-[0069]).
Before the effective filing date, it would have been obvious to the one of the ordinary skill in the art to include the feature of in response to an insufficient resource capacity, generate, for communication to a network device, the output data, as disclose by Goldfain, to the device of Innovations. The motivations is to save power by disconnecting the device when is not transmitting.
Regarding claim 16: Innovations disclose the computing device of claim 1, but does not explicitly disclose further comprising communication circuitry configured to communicatively couple the computing device with the medical device and the remote computing system; wherein the instructions further cause the processing circuitry to: based on a determination that a network device is available for transmitting data to the remote computing system, perform, via the communication circuity, at least one of retrieve, from the medical device a portion of the monitored physiological data or communicate, to the remote computing system, the output data or second output data comprising the at least a portion of the monitored physiological data.
In analogous art regarding medical devices of non huma subject, Goldfain disclose communication circuitry configured to communicatively couple the computing device with the medical device and the remote computing system; wherein the instructions further cause the processing circuitry to: based on a determination that a network device is available for transmitting data to the remote computing system, perform, via the communication circuity, at least one of retrieve, from the medical device a portion of the monitored physiological data or communicate, to the remote computing system, the output data or second output data comprising the at least a portion of the monitored physiological data (para [0065]-[0069]).
Before the effective filing date, it would have been obvious to the one of the ordinary skill in the art to include the feature communication circuitry configured to communicatively couple the computing device with the medical device and the remote computing system; wherein the instructions further cause the processing circuitry to: based on a determination that a network device is available for transmitting data to the remote computing system, perform, via the communication circuity, at least one of retrieve, from the medical device a portion of the monitored physiological data or communicate, to the remote computing system, the output data or second output data comprising the at least a portion of the monitored physiological data, as disclose by Goldfain, to the device of Innovations. The motivations is to save power by disconnecting the device when is not transmitting.
Regarding claim 17: Innovations disclose the computing device of claim 16, wherein to determine availability of the communication network, the processing circuitry is configured to at least one of: broadcast a polling message for detecting a network device of the communication network within an area; listen for a second polling message or an acknowledgment of the first polling message from a network device of the communication network within the area; or determine whether location data indicates a network device of the communication network is within an effective distance for receiving a data transmission based on receiving at least one of the second polling message or the acknowledgment of the first polling message comprising the location data. (para [0065]-[0069]).
Regarding claim 18: Innovations disclose the computing device of claim 16, wherein to determine availability of the medical device for data transmission, the processing circuitry is configured to: in response to determination that the communication network is available, transition between a first power mode and a second power mode, wherein the second power mode consumes less power than the first power mode or the second power mode consumes more power than the first power mode. (para [0065]-[0069]).
Regarding claim 21: Innovations disclose the computing device of claim 9, but does not explicitly disclose wherein the memory further comprises instructions that, when executed by the processing circuitry, cause the processing circuitry to: in response to an insufficient resource capacity, generate, for communication to a network device, the output data comprising the monitored physiological data.
In analogous art regarding medical devices of non huma subject, Goldfain disclose wherein the memory further comprises instructions that, when executed by the processing circuitry, cause the processing circuitry to: in response to an insufficient resource capacity, generate, for communication to a network device, the output data comprising the monitored physiological data. (para [0065]-[0069]).
Before the effective filing date, it would have been obvious to the one of the ordinary skill in the art to include the feature of wherein the memory further comprises instructions that, when executed by the processing circuitry, cause the processing circuitry to: in response to an insufficient resource capacity, generate, for communication to a network device, the output data comprising the monitored physiological data, as disclose by Goldfain, to the device of Innovations. The motivations is to save power by disconnecting the device when is not transmitting.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Innovations (WO 2014/150115) in view of Karnik et al. (US 2019/0082968).
Regarding claim 25: Innovations disclose the computing device of claim 1, but does not explicitly disclose wherein the health event comprises at least one of an episode of arrhythmia, cardiac arrest, myocardial infarction, stroke, seizure, or poaching attack. However it does disclose further analysis of the data at a remote location (i.e. DMS 301) (par [0085]-[0087]).
In analogous art regarding medical devices of non human subject, Karnik disclose wherein the health event comprises at least one of an episode of arrhythmia, cardiac arrest, myocardial infarction, stroke, seizure, or poaching attack. (para [0018], [0132-0133])
Before the effective filing date, it would have been obvious to the one of the ordinary skill in the art to include the feature of wherein the health event comprises at least one of an episode of arrhythmia, cardiac arrest, myocardial infarction, stroke, seizure, or poaching attack. However it does disclose further analysis of the data at a remote location, as disclose by Karnik, to the device of Innovations. The motivations is to provided quicker feedback so the event can be attended quicker.
Response to Arguments
Applicant's arguments filed 12/11/2025 have been fully considered but they are not persuasive. Applicant argue in substance:
Applicant argue that the Office Action did not include each and every limitation as claim 1 recites “output data comprising an indication of a health event the at least a portion of the monitored physiological data”.
Examiner respectfully disagrees: the limitation in question was inadvertently left out on the writing but addressed on the rejection as the prior art teaches the limitation in question (See rejection above).
Applicant argue that the DMA 301, not the wearable device 101, is used to determine the meaning of the received data, such as whether the received data is a DMS derived event.
Examiner respectfully disagrees: examiner interpretation is that a physiological measurement that meet a threshold is an “indication of a health event”. That fact that the system transmit the data to a remote system, so that the system can further analyze the data to provide further information, does not take away the fact that the a physiological measurement that meets a threshold is an “indication of a health event” and said physiological measurement is transmitted (i.e. output data comprising indication of a health event (threshold) and at least portion of the data (sensor measurement itself)) for storing on remote computing system for further analysis as taught by the prior art (See rejection above).
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 OMAR CASILLASHERNANDEZ whose telephone number is (571)270-5432. The examiner can normally be reached Monday-Friday, 8:30AM-4:30PM.
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/OMAR CASILLASHERNANDEZ/ Primary Examiner, Art Unit 2689
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