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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the electroacoustic transducer (claim 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Regarding the transducer; as is known in the art a transducer is a component/element of a microphonei. Figure 10 shows a microphone as 1006, it is assumed that the transducer is an element of this microphone however it is not shown. For the purposes of examination, based on the current understanding of microphones, the transducer will be considered to be a component or element of the microphone.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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, 10, 18, 19 and 21-22 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 line 3 recites “a microphone” and line 4 recites “an electrostatic transducer”. It is unclear if electrostatic transducer is part of the microphone or some other component. This language is therefore indefinite.
Claim 10 recites “determine a magnitude of change in an AC portion of the signal”. Claim 10 depends from claim 1. Claim 1 recites “process signals from the motion sensor” and “process signals from the optical sensor”. Therefore it is unclear which signal is “the signal” as recited in claim 10.
Regarding claim 18: the claim recites “the ear-wearable device is configured to query the device wearer regarding their condition”. It is unclear from the claim language as well as the specification how the device queries the user. The components listed in claim 1 do not provide for any indication of how the user is queried.
Regarding claim 19: the claim recites “wherein the ear-wearable device is configured to evaluate a reaction speed of the device wearer after they assume a standing position.” It is unclear from the claim language as well as the specification how the device evaluates reaction speed of the user. The components listed in claim 1 do not provide for any indication of how the reaction speed is evaluated.
Regarding claims 21-22: the claim recites “from the motion sensor to detect postural sway”. It is unclear from the claim language as well as the specification how the device processes motion sensor signals to determine postural sway. The components listed in claim 1 do not provide for any indication of how the postural sway is determined.
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.
Claims 1-2, 8, 20, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over LeBoeuf et al. US 2013/0131519 in view of Vollmer US 2017/0265782.
Regarding claim 1: LeBoeuf discloses an ear wearable device 50 (“ear bud”, figure 11A) comprising a control circuit (“microprocessor” or “signal processor”, paragraphs 0025, 0028, 0033 and 0037); a microphone (“One or more microphones, such as electrets, MEMS, acoustic transducers, or the like, may also be located within the headset housing or earbud housing to pick up speech, physiological sounds, and/or environmental sounds.” paragraph 0135), as is known in the art microphones include a transducer, stated differently transducers are a part of a microphone. LeBoeuf further discloses a sensor package 70 (“sensor module”, figure 11A) including an accelerometer and optical sensors (paragraph 0179), the optical sensors are considered to the emitters 24 (figure 11A) and detectors 24 (figure 11A). Each of the above components are operably connected to the processor (paragraphs 0025, 0028, 0033 and 0037). LeBoeuf further discloses that the optical sensors are PPG sensors to measure blood flow data (paragraph 0193). LeBoeuf further discloses measuring heart/pulse rate (paragraphs 0022, 0026, 0182), blood pressure (paragraphs 0026, 0193) and motion related data (paragraph 0024, 0184) and an accelerometer that can measure motion data (paragraph 0187). Therefore, the hardware components claimed in claim 1 are disclosed by LeBoeuf. LeBoeuf however does not disclose detecting postural transition to a standing position, triggering the optical sensors and processing signals from the optical sensors. However, Vollmer teaches of a device which uses accelerometers detects motion from sitting to standing (figure 1 and paragraphs 0002, 0005). In the device of Vollmer there is a resting state 16 (figure 1, shown as seated) and a motion triggered state 18 (figure 1, shown as standing). In the resting state 16 vital signs are not monitored, the device is triggered to monitor vital signs once the motion triggered state is detected (paragraphs 0020-0021). Once triggered the vital signs monitor blood pressure, pulse and EEG (paragraph 0022) to determine syncope which is associated with orthostatic stress (paragraphs 0002, 0021, 0023). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf to include processing accelerometer signals to determine when the patent moves from a sitting to a standing position and activating the sensors to monitor blood pressure and heart rate, as taught by Vollmer, in order to monitor syncope which is associated with orthostatic stress.
Regarding claim 2: LeBoeuf/Vollmer discloses the claimed invention. However, LeBoeuf/Vollmer of claim 1 does not disclose that the condition is orthostatic hypotension. Vollmer further teaches of hemodynamic problems such as orthostatic hypotension (paragraphs 0001-0002). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer of claim 1 to include vital sign monitoring which can indicate orthostatic hypotension, as taught by Vollmer, in order to aid in preventing falling (paragraph 0002, Vollmer).
Regarding claim 8: LeBoeuf/Vollmer discloses the claimed invention. However, LeBoeuf/Vollmer of claim 1 does not disclose determining blood flow morphology, which is considered to be blood pressure. Vollmer however teaches of monitoring blood pressure (paragraph 0022). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer to include monitoring blood pressure, as taught by Vollmer, in order to determine symptoms of syncope (paragraph 0023).
Regarding claim 20: LeBoeuf/Vollmer discloses the claimed invention. However, LeBoeuf/Vollmer of claim 1 does not disclose sending an alert to a caregiver. Vollmer however teaches of sending the alert to a caregiver 30 (figure 1, paragraph 0024). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer to include sending an alert to a caregiver, as taught by Vollmer, in order to prevent syncope.
Regarding claims 23-24: LeBoeuf/Vollmer discloses the claimed invention. However, LeBoeuf/Vollmer does not disclose processing the signal to determine a starting posture and transition to standing and triggering operation of the sensors upon the transition from lying or sitting. Vollmer however teaches of a started seated position 16 (figure 1), the patient transitions to a standing position 18 (figure 1). Once motion is detected the vital sign device monitors vital signs and sends an alert if issues are detected in the vital signs indicating orthostatic hypotension (paragraphs 0002, 0020-0021). As is discussed in paragraph 0021 whole body movement is monitored to determine standing from other body motions such as respiration, which is considered to be monitoring standing from sublime postures. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer to include monitoring the motion signal to determine sitting from standing and the transition to standing, as taught by Vollmer, in order to appropriately trigger the sensors to monitor blood pressure and heart rate do determine orthostatic stress (Vollmer, paragraph 0021).
Claims 4-7 and 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over LeBoeuf et al. US 2013/0131519 in view of Vollmer US 2017/0265782 and further in view of Eun Young Yang US 2021/0219923 herein Yang.
Regarding claim 4: LeBoeuf/Vollmer discloses the claimed invention however LeBoeuf/Vollmer does not disclose processing the measured signals from the optical sensor to detect inter-beat interval changes. Yang however teaches of a system for providing alerts related to fall risk (title) in which blood pressure and heart rate are utilized in order to obtain heart rate variability data (abstract). In the Yang method the RR intervals are determined from PPG signals (paragraph 0057). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer to include using the PPG signals to determine RR intervals and thus HRV. It is noted that heart rate variability (HRV) is the sequence of time intervals between heart beats and is an inter-beat interval time series which shows variability (changes in time)ii. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer to include the optical sensor detecting RR intervals to determine heart rate variability (inter-beat interval changes), as taught by Yang, in order to minimize fall injury based on abnormal blood pressure and/or heart rate (paragraphs 0005-0006 of Yang).
Regarding claim 5: LeBoeuf/Vollmer discloses the claimed invention however LeBoeuf/Vollmer does not disclose processing the measured signals from the optical sensor to detect decreased variability which indicates orthostatic intolerance. Yang however, teaches of monitoring the RR interval in time, a decrease of RR is correlated to an increase or fast heart rate (paragraph 0079) which is then correlated to compromised PNS (parasympathetic nervous system) activity (paragraph 0079). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer to include monitoring RR intervals to determine decreased RR interval activity, as taught by Yang, in order to determine the PNS is in a compromised state which indicates orthostatic stress is present (paragraphs 0008 and 0080).
Regarding claim 6: LeBoeuf/Vollmer discloses the claimed invention however LeBoeuf/Vollmer. Vollmer further discloses measuring pulse (paragraph 0022). However, LeBoeuf/Vollmer does not disclose detecting pulse rate (i.e. heart rate) changes. Yang however teaches of measuring heart rate and determining heart rate variability (abstract). An abnormal heart rate is considered to be an increase of more than 30 BPM upon standing (paragraph 0007). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer to include determining a change in heart rate, as taught by Yang, in order to determine abnormal values upon standing.
Regarding claim 7: LeBoeuf/Vollmer discloses the claimed invention however LeBoeuf/Vollmer, however, LeBoeuf/Vollmer does not disclose determining when the heart rate exceeds a threshold. Yang however teaches of a baseline heart rate, considered to be a threshold and upon standing if the heart rate is greater than 30 BPM above the baseline, determining that this is an abnormal heart rate. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer to include establishing a baseline heart rate and monitoring the heart rate while standing to determine if the heart rate passes a threshold, as taught by Yang, in order to determine an abnormal heart rate.
Regarding claim 9: LeBoeuf/Vollmer discloses the claimed invention however LeBoeuf/Vollmer, however, LeBoeuf/Vollmer does not disclose determining and/or utilizing reduced systolic blood pressure. Yang however, teaches that a sustained fall in systolic blood pressure from a baseline indicates an abnormal blood pressure (paragraph 0007) which also is indicative of an OH state (orthostatic hypotension, paragraph 0004). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer to include monitoring for a sustained fall in systolic blood pressure from a baseline, as taught by Yang, in order to determine abnormal blood pressure and an orthostatic hypotension state.
Regarding claim 10: LeBoeuf/Vollmer discloses the claimed invention however LeBoeuf/Vollmer, however, LeBoeuf/Vollmer does not disclose determining a magnitude of change in an AC portion of the signals. It is known in the art that the AC portion of a blood pressure signal taken from a PPG sensor will be the part of the signal analyzed for changes in blood pressure iii. Further, when monitoring systolic blood pressure the peak and/or max systolic blood pressure will be measured. Yang however teaches of determining a baseline systolic blood pressure value, upon assuming an upright position if the systolic blood pressure drops ≥ 20 mmHg this is considered to be abnormal (paragraph 0007) and indicative of a fall risk (paragraph 0007) due to orthostatic stress (paragraph 0008). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer to include monitoring systolic blood pressure for a sustained decrease in systolic blood pressure, as taught by Yang, in order to determine fall risk associated with orthostatic stress (paragraphs 0007-0008).
Regarding claim 11: LeBoeuf/Vollmer discloses the claimed invention however LeBoeuf/Vollmer, however, LeBoeuf/Vollmer does not disclose determining a recovery rate of the signal to normal levels. Yang however teaches of monitoring the recovery of the blood pressure (paragraph 0007), which is considered to be a recovery rate. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer to include monitoring for a sustained blood pressure drop, as taught by Yang, in order to determine fall risk associated with orthostatic stress (paragraphs 0007-0008).
Regarding claim 12: LeBoeuf/Vollmer discloses the claimed invention however LeBoeuf/Vollmer, however, LeBoeuf/Vollmer does not disclose determining a magnitude of change in an AC portion of the signals as well as a sustained duration of change. Yang however teaches of determining a baseline systolic blood pressure value, upon assuming an upright position if the systolic blood pressure drops ≥ 20 mmHg this is considered to be abnormal (paragraph 0007) and indicative of a fall risk (paragraph 0007) due to orthostatic stress (paragraph 0008). Yang further teaches of monitoring the recovery of the blood pressure (paragraph 0007), which is considered to be a recovery rate. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer to include monitoring for a sustained blood pressure drop, as taught by Yang, in order to determine fall risk associated with orthostatic stress (paragraphs 0007-0008). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer to include monitoring systolic blood pressure for a sustained decrease in systolic blood pressure as taught by Yang, in order to determine fall risk associated with orthostatic stress (paragraphs 0007-0008).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over LeBoeuf et al. US 2013/0131519 in view of Vollmer US 2017/0265782 and further in view of Stephens et al. US 2021/0052175.
Regarding claim 16: LeBoeuf/Vollmer discloses the claimed invention however, LeBoeuf/Vollmer does not disclose prompting the user to stand. Stephens however teaches of prompting a user to perform a sit-and-stand test (paragraph 0030). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer to include prompting the user to perform a sit-and-stand test, as taught by Stephens, in order to determine cardiovascular events.
Regarding claim 17: LeBoeuf/Vollmer discloses the claimed invention however, LeBoeuf/Vollmer does not disclose prompting the user to stand using a secondary device. Stephens however teaches of prompting a user to perform a sit-and-stand test (paragraph 0030). Stephens further discloses a communication interface which can communicate and transmit data to a mobile phone (paragraph 0047). It certainly is within the skill of one of ordinary skill in the art to transfer the prompts to the phone in order to prompt for the sit and stand test. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Le/Boeuf to include a sit and stand prompt, and sending that sit and stand prompt to a user on a secondary device in that this would only take routine skill in the art.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over LeBoeuf et al. US 2013/0131519 in view of Vollmer US 2017/0265782 and further in view of Lightcap et al. US 2021/0030610.
Regarding claim 18: LeBoeuf/Vollmer discloses the claimed invention. However, LeBoeuf/Vollmer does not disclose querying the user regarding their symptoms upon standing. Lightcap however teaches of an automated orthostatic assessment in which the patient symptoms such as dizziness and light headedness are additional factors that the algorithm takes into account (paragraph 0061). Using a user interface the patient or the caregiver are input into the system (paragraph 0062). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer to include queuing the user or caregiver to input symptoms upon standing, as taught by Lightcap, in order to assess orthostatic hypotension (paragraph 0063 Lightcap).
Claims 19 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over LeBoeuf et al. US 2013/0131519 in view of Vollmer US 2017/0265782 and further in view of Burnwinkel et al. US 2020/0205746.
Regarding claim 19: LeBoeuf/Vollmer discloses the claimed invention. However, LeBoeuf/Vollmer does not disclose evaluating reaction speed. Burnwinkel however teaches of a predictive fall system which monitors reaction speed (paragraphs 0091-62). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to monitor reaction speed, as taught by Burnwinkel, in order to assess motion patterns.
Regarding claim 21: LeBoeuf/Vollmer discloses the claimed invention. However, LeBoeuf/Vollmer does not disclose evaluating postural sway. Burnwinkel however teaches of a predictive fall system which monitors sway amplitude (paragraphs 0091-62). It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to monitor sway amplitude, as taught by Burnwinkel, in order to assess motion patterns.
Regarding claim 22: LeBoeuf/Vollmer/Burnwinkel discloses the claimed invention. As is taught by Vollmer an alert is sent caregiver 30 as well as the device 30 (figure 1, paragraph 0024). Burnwinkel further teaches of a predictive fall system which monitors sway amplitude (paragraphs 0091-62). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify LeBoeuf/Vollmer/Burnwinkel of claim 21 to include alerts based on postural sway, with postural sway taught by Burwinkle.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rapalis, A., Janušauskas, A., Marozas, V., & Lukoševičius, A. (2017). Estimation of blood pressure variability during orthostatic test using instantaneous photoplethysmogram frequency and pulse arrival time. Biomedical Signal Processing and Control, 32, 82–89. https://doi.org/10.1016/j.bspc.2016.10.014
Seok, H. Y., Kim, Y. H., Kim, H., & Kim, B.-J. (2018). Patterns of orthostatic blood pressure changes in patients with orthostatic hypotension. Journal of Clinical Neurology, 14(3), 283. https://doi.org/10.3988/jcn.2018.14.3.283
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAULA J. STICE whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl H Layno can be reached at 571-272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
i https://www.shure.com/en-US/insights/mic-basics-transducers
ii https://www.sciencedirect.com/topics/medicine-and-dentistry/interbeat-interval
iii https://pmc.ncbi.nlm.nih.gov/articles/PMC4986809/