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 .
Election/Restrictions
Applicant's election with traverse of Group 2 (claim 27) in the reply filed on October 21, 2025 is acknowledged. The traversal is on the ground(s) that it would not be an unduly burdensome for the Examiner. This is not found persuasive because this restriction is not based on burden, instead it is based on the requirement for Unity of Invention.
The requirement is still deemed proper and is therefore made FINAL.
Response to Amendment
This office action is responsive to the preliminary amendment filed on October 21, 2025. As directed by the amendment: no claim(s) have been amended, claim(s) 1-26 have been cancelled, and claim(s) 75-93 have been added. Thus, claims 27 and 75-93 are currently pending in the application.
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 85 and 87-89 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 85 recites the limitation "the accessory device" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 87 recites the limitation "the alert" in line 2. There is insufficient antecedent basis for this limitation in the claim. The examiner has understood that this claim should be dependent on claim 86 and not claim 27.
Claim 88 recites the limitation "the alert" in line 2. There is insufficient antecedent basis for this limitation in the claim. The examiner has understood that this claim should be dependent on claim 86 and not claim 27.
Claim 89 recites the limitation "the predicted severity" in line 1. There is insufficient antecedent basis for this limitation in the claim. The examiner has understood that this claim should be dependent on claim 88 and not claim 27.
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) 27, 77-79, 81-84, and 86-93 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Calcano (US 2016/0262694 A1).
Regarding claim 27, Calcano discloses an ear-wearable device system comprising: a first ear-wearable device, the first ear-wearable device comprising a first control circuit (e.g. [0040]); a first microphone, wherein the first microphone is in electrical communication with the first control circuit (e.g. [0032] [0108]); a first motion sensor, wherein the first motion sensor is in electrical communication with the first control circuit (e.g. [0036]; [0039]); and a first power supply circuit, wherein the first power supply circuit is in electrical communication with the first control circuit (e.g. [0062]-[0063] the PIMs are wired to connect to a bank charger to provide battery charging of the PIM which means its powered by a battery); wherein the ear-wearable device system is configured to process signals from the first motion sensor and the second motion sensor to calculate at least one of rotational acceleration, rotational velocity, and linear acceleration (e.g. [0036]; [0039]; “The PIM may include one or more sensors adapted to sense rotational accelerations and may also include one or more sensors to detect linear accelerations.” [0041]; [0081]-[0083]); and wherein the ear-wearable device system is configured to monitor at least one of rotational acceleration, rotational velocity, and linear acceleration to detect an occurrence of peak acceleration consistent with possible head (e.g. [0041]-[0042]).
Calcano doesn’t explicitly state that there is a second ear-wearable device; however, it details in [0058] and [0091] that multiple devices can be utilized on the user and would read on the limitations above for a second ear-wearable device.
In the instance, the applicant believes that it is not explicitly disclosed and anticipated by the prior art, the examiner also presents that it would have been obvious to modify as detailed below.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Calcano to utilize two ear-wearable devices as the prior art Calcano discloses that there can be a device attached to either side a body part for the purpose of being able to identify specific injuries (e.g. [0091]).
Additionally, this appears to be a mere duplication of parts as the prior art Calcano already details in [0058] and [0091] that multiple devices can be utilized on the user. Therefore, it would have been obvious to one of ordinary skill to duplicate this for the user in order to monitor different aspects of the user. Please refer to MPEP 2144.04(VI)(B).
Regarding claim 77, modified Calcano discloses wherein the ear-wearable device system in configured to process signals from at least one of the first motion sensor and the second motion sensor to estimate linear acceleration at a center of gravity of the head of a wearer of the ear-wearable device system (e.g. [0151]-[0152]; Fig 21)
Regarding claim 78, modified Calcano discloses wherein the ear-wearable device system is configured to record detected occurrences of peak acceleration and/or peak velocity consistent with possible head trauma (e.g. [0042]; [0049]; [0184]).
Regarding claim 79, modified Calcano discloses wherein the ear-wearable device system is configured to calculate a cumulative impact index based on the recorded detected occurrences of peak acceleration and/or peak velocity consistent with possible head trauma (e.g. [0088] compliance limits are set as a cumulative measure).
Regarding claim 81, modified Calcano discloses wherein the ear-wearable device system is configured to generate an audio warning (e.g. [0050]; [0067]; [0087]; [0094]; [0165]) when an occurrence of peak acceleration and/or velocity consistent with possible head trauma is detected (e.g. [0153]-[0161] the system utilizes the peak/maximum to determine a head injury criterion).
Regarding claim 82, modified Calcano discloses wherein the ear-wearable device system is configured to generate an audio warning and send the same to a responsible third party when an occurrence of peak acceleration and/or velocity consistent with possible head trauma is detected (e.g. [0067]).
Regarding claim 83, modified Calcano wherein the ear-wearable device system is configured to generate a query for a wearer of the ear-wearable device system when an occurrence of peak acceleration and/or velocity consistent with possible head trauma is detected (e.g. Fig 26:2616 [0165] the system has a button to acknowledge an impact which can trigger an injury assessment instrument).
Regarding claim 84, modified Calcano wherein the ear-wearable device system is configured to generate a delayed query for a wearer of the ear-wearable device system when an occurrence of peak acceleration and/or velocity consistent with possible head trauma is detected (e.g. Fig 26:2616 [0165] the system has a button to acknowledge an impact which can later or delay a trigger an injury assessment instrument).
Regarding claim 86, modified Calcano discloses wherein the ear-wearable device system is configured to a generate an alert if an occurrence of possible head trauma is detected that crosses a threshold value (e.g. [0087]; [0094]; [0165]).
Regarding claim 87, modified Calcano discloses wherein the ear-wearable device system is configured to select an appropriate first target recipient for the alert (e.g. [0087]; [0094]; [0165] custom thresholds may be set for individual participants).
Regarding claim 88, modified Calcano discloses wherein the ear-wearable device system is configured to select an appropriate first target recipient for the alert based on a predicted severity of possible head trauma (e.g. [0087]-[0088] individual impact thresholds can be customized to be set and override global thresholds and have compliance limits based on the individual especially if they are following a certain leagues protocol including previous impact limits, number of impacts and cumulative measure of impact strength including a concussion assessment).
Regarding claim 89, modified Calcano discloses wherein the predicted severity is based on factors including one or more of peak detected acceleration, peak detected velocity, post-incident monitoring data, pre-incident monitoring data, and initial phase detection (e.g. [0087]-[0088] individual impact thresholds can be customized to be set and override global thresholds and have compliance limits based on the individual especially if they are following a certain leagues protocol including previous impact limits, number of impacts and cumulative measure of impact strength including a concussion assessment).
Regarding claim 90, modified Calcano discloses wherein post-incident monitoring data includes at least one of microphone signals and motion sensor signals (e.g. [0177]; [0181]-[0182]).
Regarding claim 91, modified Calcano discloses further comprising: a physiological sensor, the physiological sensor comprising at least one selected from the group consisting of a blood pressure sensor and a heart rate sensor (e.g. [0109]; [0112])
Regarding claim 92, modified Calcano discloses wherein the ear-wearable device system is configured to stream data based on the signals from at least one of the first microphone, the first motion sensor, the second microphone, and the second motion sensor after detection an occurrence of head movement consistent with possible head trauma, wherein signals from the first motion sensor or the second motion sensor that cross a threshold value of acceleration and/or velocity are consistent with possible head trauma (e.g. [0142]-[0144]).
Regarding claim 93, modified Calcano wherein the ear-wearable device system is configured to compare signals from the first motion sensor and the second motion sensor to detect a false positive event (e.g. [0061]).
Claim(s) 75-76 are rejected under 35 U.S.C. 103 as being unpatentable over Calcano as applied to claim 27 above, and further in view of Jones (US 9,049,558 B2)
Regarding claim 75, modified Calcano is silent regarding wherein the ear-wearable device system is configured to change a sampling rate of at least one of the first motion sensor and the second motion sensor if movement is detected consistent with an initial phase of an impact event.
However, modified Calcano does disclose in [0149]-[0150] the ability to resample to a desired sample rate if it is determined a new sample rate is needed.
Additionally, Jones discloses a system and method for determining mobile thing motion activity using sensor data wherein the ear-wearable device system is configured to change a sampling rate of at least one of the first motion sensor and the second motion sensor if movement is detected consistent with an initial phase of an impact event (e.g. Fig 23C col 60 lines 20-50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified system of Calcano to incorporate the teachings of Jones wherein the ear-wearable device system is configured to change a sampling rate of at least one of the first motion sensor and the second motion sensor if movement is detected consistent with an initial phase of an impact event for the purpose of enhancing detection (e.g. Jones col 60 lines 20-22 and 34-38).
Regarding claim 76, modified Calcano is silent regarding wherein the ear-wearable device system is configured to increase a sampling rate of at least one of the first motion sensor and the second motion sensor if movement is detected consistent with an initial phase of an impact event.
However, modified Calcano does disclose in [0149]-[0150] the ability to resample to a desired sample rate if it is determined a new sample rate is needed.
Additionally, Jones discloses a system and method for determining mobile thing motion activity using sensor data wherein the ear-wearable device system is configured to increase a sampling rate of at least one of the first motion sensor and the second motion sensor if movement is detected consistent with an initial phase of an impact event (e.g. Fig 23C col 60 lines 20-50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified system of Calcano to incorporate the teachings of Jones wherein the ear-wearable device system is configured to increase a sampling rate of at least one of the first motion sensor and the second motion sensor if movement is detected consistent with an initial phase of an impact event for the purpose of enhancing detection (e.g. Jones col 60 lines 20-22 and 34-38).
Claim(s) 80 is rejected under 35 U.S.C. 103 as being unpatentable over Calcano as applied to claim 27 above, and further in view of Burwinkle (US 2018/0228405 A1)
Regarding claim 80, modified Calcano is silent regarding wherein the ear-wearable device system is configured monitor signals from at least one of the first motion sensor and the second motion sensor to detect at least one of dizziness or a fall after detecting an occurrence of head movement consistent with possible head trauma.
However, Burwinkle teach a fall prediction system wherein the ear-wearable device system is configured monitor signals from at least one of the first motion sensor and the second motion sensor to detect at least one of dizziness or a fall after detecting an occurrence of head movement consistent with possible head trauma (e.g. [0106]-[0111]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified system of Calcano to incorporate the teachings of Burwinkle wherein the ear-wearable device system is configured monitor signals from at least one of the first motion sensor and the second motion sensor to detect at least one of dizziness or a fall after detecting an occurrence of head movement consistent with possible head trauma for the purpose of being able to provide real-time feedback (e.g. Burwinkle [0111]).
Claim(s) 85 is rejected under 35 U.S.C. 103 as being unpatentable over Calcano as applied to claim 27 above, and further in view of Benzel (US 2016/0106346 A1)
Regarding claim 85, Calcano is silent regarding wherein the ear-wearable device system is configured to estimate a degree of possible damage to a neck of the ear-wearable device system wearer based on a comparison of signals from at least one of the first motion sensor and the second motion sensor and signals from the accessory device.
However, Benzel discloses a system a wherein the ear-wearable device system (e.g. [0033]) is configured to estimate a degree of possible damage to a neck of the ear-wearable device system wearer based on a comparison of signals from at least one of the first motion sensor and the second motion sensor and signals from the accessory device (e.g. [0033]-[0034]; [0056]-[0057]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the modified system of Calcano to incorporate the teachings of Benzel wherein the ear-wearable device system is configured to estimate a degree of possible damage to a neck of the ear-wearable device system wearer based on a comparison of signals from at least one of the first motion sensor and the second motion sensor and signals from the accessory device for the purpose of being a triage tool for a physician (e.g. Benzel [0034]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSANDRA F HOUGH whose telephone number is (571)270-7902. The examiner can normally be reached Monday-Thursday 7 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571)270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Jessandra Hough November 9, 2025
/J.F.H./Examiner, Art Unit 3796
/William J Levicky/Primary Examiner, Art Unit 3796
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