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 .
Response to Arguments
Applicant's arguments filed 1/23/2026 have been fully considered but they are not persuasive. Applicant argues that Karow does not mention anything related to a health of an inner ear or stimulating, much less adjusting stimulation of, an inner ear. The Applicant argues that detecting arrythmia is different from identifying a precursor to a health of an inner ear. The examiner respectfully disagrees as the Applicant has not identified specifically how the prior art functions differently. The claims as currently written do not preclude the determinations of Karow from being the health of an inner ear and adjusting stimulation provided to the inner ear in response. For example Karow in Paragraphs [0008] and [0021] discloses that the apparatus is configured to be worn in the ear. Paragraph [0035] discloses obtaining PPG data and delivering stimulation in Paragraphs [0034] and [0051]. The examiner also notes that the instant disclosure in published paragraph [0038] discloses “the precursors to cochlea health include inflammation or cardiovascular condition(s) that are detectable via the PPG sensor 119A and/or individual changes in one or more of a heart rate, cardiac cycle”. Therefore, the instant invention includes detection of changes in heart rate and/or cardiac cycle in order to determine the health of the cochlea (inner ear). As discussed above Karow uses a PPG worn in the ear and as argued by Applicant Karow determines arrythmia. Karow then adjusts the stimulation of the device worn in the ear. Therefore, the Karow does disclose the recitations argued by Applicant as not mentioned.
The Applicant argues that Karow does not specifically disclose identifying an infection or a risk of an inflammatory condition of a middle ear. The examiner respectfully disagrees as the instant invention in published paragraph [0041] discloses that the PPG sensor indicates a systemic infection that risks propagation to the cochlea or vestibular system. Because a systemic infection increases the risk of propagation to the cochlea. Therefore, the claim limitations do not preclude the teaching of Karow.
Applicant’s arguments regarding claim 15 are persuasive and the rejection of claim 15 is withdrawn.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 4, 14, 16-17, and 21-23 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Karow et al (US Publication 2022/0409847).
Referring to Claims 1 and 17, Karow et al teaches a method/ implantable medical device, comprising: obtaining, at an implantable medical device, input from a photoplethysmography (PPG) sensor (e.g. Paragraphs [0031] and [0035], and Figure 1, Element 250); analyzing, at the implantable medical device, the input to identify a precursor of a change to a health of an inner ear of a recipient of the implantable medical device (e.g. Paragraphs [0034] and [0035] discloses detecting arrythmia of the patient and Figure 1, Element 130); adjusting stimulation provided to the inner ear via the implantable medical device in response to the identified precursor (e.g. Paragraph [0034] discloses adjusting one or more electrical characteristics of the stimulation based on the response from the biological signal monitoring apparatus).
Referring to Claim 2, Karow et al teaches the method of claim 1, wherein analyzing the input to identify the precursor of the change to the health of the inner ear of the recipient comprises: identifying at least one of an infection or a risk of an inflammatory condition of a middle ear or the inner ear of the recipient (e.g. Paragraph [0051]).
Referring to Claims 4 and 23, Karow et al teaches the claimed invention, wherein the input indicates one or more of a heart rate, a cardiac cycle, a respiration, a blood pressure, or a blood oxygenation level of the recipient (e.g. Paragraph [0035] discloses PPG data is then used to calculate R-R intervals then used to calculate the RSA (respiratory sinus arrhythmia)).
Referring to Claim 14, Karow et al teaches the method of claim 1, wherein the PPG sensor is implanted in an ear canal of the recipient (e.g. Paragraphs [0008] and [0020] discloses the housing fits within the ear).
Referring to Claim 16, Karow et al teaches the method of claim 1, wherein the PPG sensor is attached to a location on a body of the recipient that is external to an ear of the recipient (e.g. Paragraph [0008] discloses the device is worn about the head of the patient).
Referring to Claim 21, Karow et al teaches the implantable medical device of claim 17, wherein the hardware processor is configured to: determine a probability of an inflammatory condition of a middle ear of the recipient based on the cardiovascular parameter, wherein the adjusting of the electrical stimulation signals is based on the probability (e.g. Paragraph [0051]).
Referring to Claim 22, Karow et al teaches the implantable medical device of claim 17, wherein the precursor of the change to the health of the inner ear of the recipient comprises a probability of an infection of the inner ear of the recipient (e.g. Paragraph [0051]).
Claim(s) 5, 9, 24 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karow et al (US Publication 2022/0409847) in view of John et al (US Publication 2008/0188762).
Referring to Claims 5 and 24, Karow et al teaches the claimed invention, except further comprising: determining a confidence score based on the input; evaluating the confidence score against a predefined criterion, wherein the adjusting of the stimulation is based on the evaluating.
John et al teaches that it is known to detect the cardiac abnormality if both a first detection criterion and a second detection criterion is satisfied, and wherein the first detection criterion requires N1 number of segment scores to have a characteristic which is above a first threshold and a second criterion requires N2 number of segment scores to have the characteristic which is above a second higher threshold as set forth in claim 15 and Paragraph [0124] to provide improved detection of abnormal criteria by reducing the likelihood of a false positive. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Karow et al, with further comprising: determining a confidence score based on the input; evaluating the confidence score against a predefined criterion, wherein the adjusting of the stimulation is based on the evaluating as taught by John et al, since such a modification would provide the predictable results of improved detection of abnormal criteria by reducing the likelihood of a false positive.
Referring to Claim 9, Karow et al teaches the method of claim 1, discloses additional monitoring of ECG data. However, Karow et al does not further comprising: determining a confidence score based on a second input from another in-vivo sensor, wherein the obtaining of the input is in response to the confidence score meeting a criterion.
John et al teaches that it is known to detect the cardiac abnormality if both a first detection criterion and a second detection criterion is satisfied, and wherein the first detection criterion requires N1 number of segment scores to have a characteristic which is above a first threshold and a second criterion requires N2 number of segment scores to have the characteristic which is above a second higher threshold as set forth in claim 15 and Paragraph [0124] to provide improved detection of abnormal criteria by reducing the likelihood of a false positive. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karow et al, with further comprising: determining a confidence score based on a second input from another in-vivo sensor, wherein the obtaining of the input is in response to the confidence score meeting a criterion as taught by John et al, since such a modification would provide the predictable results of improved detection of abnormal criteria by reducing the likelihood of a false positive.
Referring to Claim 28, Karow et al teaches the implantable medical device of claim 17, wherein the hardware processor is configured to: determine a confidence score based on data obtained from an in-vivo sensor, wherein the precursor of the change of the health of the inner ear of the recipient is identified in response to the confidence score meeting a criterion. John et al teaches that it is known to detect the cardiac abnormality if both a first detection criterion and a second detection criterion is satisfied, and wherein the first detection criterion requires N1 number of segment scores to have a characteristic which is above a first threshold and a second criterion requires N2 number of segment scores to have the characteristic which is above a second higher threshold as set forth in claim 15 and Paragraph [0124] to provide improved detection of abnormal criteria by reducing the likelihood of a false positive. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Karow et al, with further comprising: determine a confidence score based on data obtained from an in-vivo sensor, wherein the precursor of the change of the health of the inner ear of the recipient is identified in response to the confidence score meeting a criterion as taught by John et al, since such a modification would provide the predictable results of improved detection of abnormal criteria by reducing the likelihood of a false positive.
Claim(s) 11 and 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karow et al (US Publication 2022/0409847) in view of Kirby (US Publication 2007/0167985).
Referring to Claim 11, Karow et al teaches the method of claim 1, except wherein the implantable medical device is a vestibular device, and wherein adjusting the stimulation delivered to the inner ear of the recipient comprises: adjusting stimulation delivered to a vestibular system of the recipient.
Kirby teaches that it is known to use adjustments to a vestibular stimulation element based on sensed physiological changes (e.g. heart rate variability) as set forth in Paragraphs [0007] and [0063] and Figure 1 to provide counteracting vertigo. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karow et al, with wherein the implantable medical device is a vestibular device, and wherein adjusting the stimulation delivered to the inner ear of the recipient comprises: adjusting stimulation delivered to a vestibular system of the recipient as taught by Kirby et al, since such a modification would provide the predictable results of counteracting vertigo.
Referring to Claims 31, Karow et al teaches the implantable medical device of claim 17, wherein the implantable medical device is a vestibular device, and wherein to adjust the electrical stimulation signals delivered to the inner ear of the recipient, the hardware processor is configured to: adjust electrical stimulation signals delivered to a vestibular system of the recipient.
Kirby teaches that it is known to use adjustments to a vestibular stimulation element based on sensed physiological changes (e.g. heart rate variability) as set forth in Paragraphs [0007] and [0063] and Figure 1 to provide counteracting vertigo. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Karow et al, with wherein the implantable medical device is a hearing prosthesis/vestibular device, and wherein to adjust the electrical stimulation signals delivered to the inner ear of the recipient, the hardware processor is configured to: adjust electrical stimulation signals delivered to a vestibular system of the recipient as taught by Kirby et al, since such a modification would provide the predictable results of counteracting vertigo.
Claim(s) 10, 12, 29-30, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karow et al (US Publication 2022/0409847) in view of Heasman et al (US Publication 2017/0360364).
Referring to Claim 10, Karow et al teaches the method of claim 1, except wherein adjusting the stimulation provided via the implantable medical device comprises: reducing an intensity or overlap of the stimulation delivered to the inner ear of the recipient.
Heasman et al teaches that it is known to use adjustments to stimulation delivered to the cochlea based on in vivo measurements as set forth in Figure 2 and Paragraph [0064] to provide counteracting, terminating, or otherwise minimizing the agitation/trigger of the cochlea health change. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karow et al, with wherein the implantable medical device is a cochlear implant, and wherein adjusting the stimulation provided via the implantable medical device comprises: reducing an intensity or overlap of the stimulation delivered to the inner ear of the recipient as taught by Heasman et al, since such a modification would provide the predictable results of counteracting, terminating, or otherwise minimizing the agitation/trigger of the cochlea health change.
Referring to Claim 12, Karow et al teaches the method of claim 1, except wherein the implantable medical device is a cochlear implant, and wherein adjusting the stimulation delivered to the inner ear of the recipient comprises: adjusting stimulation delivered to a cochlea of the recipient. Heasman et al teaches that it is known to use adjustments to stimulation delivered to the cochlea based on in vivo measurements as set forth in Figure 2 and Paragraph [0064] to provide counteracting, terminating, or otherwise minimizing the agitation/trigger of the cochlea health change. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karow et al, with wherein the implantable medical device is a cochlear implant, and wherein adjusting the stimulation delivered to the inner ear of the recipient comprises: adjusting stimulation delivered to a cochlea of the recipient as taught by Heasman et al, since such a modification would provide the predictable results of counteracting, terminating, or otherwise minimizing the agitation/trigger of the cochlea health change.
Referring to Claims 29, 30 and 32, Karow et al teaches the implantable medical device of claim 17, except wherein the implantable medical device is a hearing device/cochlear device, and wherein to adjust the stimulation delivered to the inner ear of the recipient, the hardware processor is configured to: adjust stimulation delivered to a cochlea of the recipient, including lessening the intensity and/or overlap of the electrical signals delivered to the inner ear of the recipient. Heasman et al teaches that it is known to use adjustments to stimulation delivered to the cochlea based on in vivo measurements as set forth in Figure 2 and Paragraph [0064] to provide counteracting, terminating, or otherwise minimizing the agitation/trigger of the cochlea health change. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Karow et al, with wherein the implantable medical device is a hearing device/cochlear device, and wherein to adjust the stimulation delivered to the inner ear of the recipient, the hardware processor is configured to: adjust stimulation delivered to a cochlea of the recipient, including lessening the intensity and/or overlap of the electrical signals delivered to the inner ear of the recipient as taught by Heasman et al, since such a modification would provide the predictable results of counteracting, terminating, or otherwise minimizing the agitation/trigger of the cochlea health change.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karow et al (US Publication 2022/0409847) in view of Xu et al (US Publication 2020/0245938).
Referring to Claim 13, Karow et al teaches the method of claim 1, except comprising: generating, via a wireless interface of the implantable medical device, an alert signal.
Xu et al teaches that it is known to use ear worn PPG sensos to detect balance issues and risk of the user falling and based on the data generate an alert to a caregiver such as automated phone calls as set forth in Paragraphs [0075] and [0165] and Figure 1 to provide improved patient safety by alerting someone who might not be within sight or hearing range of the user. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Karow et al, with comprising: generating, via a wireless interface of the implantable medical device, an alert signal as taught by Xu et al, since such a modification would provide the predictable results of improved patient safety by alerting someone who might not be within sight or hearing range of the user.
Claim(s) 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karow et al (US Publication 2022/0409847) in view of John et al (US Publication 2008/0188762), as applied in claim 24 above, and further in view of Xu et al (US Publication 2020/0245938).
Referring to Claim 25, Karow et al in view of John et al teaches the implantable medical device of claim 24, except wherein the hardware processor is configured to: inhibit further evaluation of other biomarkers based on the evaluation.
Xu et al teaches that it is known to use first statistical data to determine an abnormal condition and when the threshold is exceeded activating a second set of sensors to obtain a second statistic on the abnormal condition as set forth in Paragraph [0165] to provide further data to identify if the patient is actually experiencing an abnormal condition or experiencing an abnormal sensed signal. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Karow et al, with inhibiting further evaluation of other biomarkers based on the evaluation as taught by Xu et al, since such a modification would provide the predictable results of further data to identify if the patient is actually experiencing an abnormal condition or experiencing an abnormal sensed signal.
Referring to Claim 26, Karow et al in view of John et al teaches the implantable medical device of claim 24, except wherein the hardware processor is configured to: obtain additional data from an in-vivo sensor in response to the evaluating, wherein the determining of the confidence score is based on the additional data.
Xu et al teaches that it is known to use first statistical data to determine an abnormal condition and when the threshold is exceeded activating a second set of sensors to obtain a second statistic on the abnormal condition as set forth in Paragraph [0165] to provide further data to identify if the patient is actually experiencing an abnormal condition or experiencing an abnormal sensed signal. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Karow et al, with obtaining additional data from an in-vivo sensor in response to the evaluating, wherein the determining of the confidence score is based on the additional data as taught by Xu et al, since such a modification would provide the predictable results of further data to identify if the patient is actually experiencing an abnormal condition or experiencing an abnormal sensed signal.
Referring to Claim 27, Karow et al teaches the implantable medical device of claim 26, except wherein the in-vivo sensor is at least one of an electrocochleography (ECoG) sensor or an inertial measurement unit. Xu et al teaches that it is known to use first statistical data to determine an abnormal condition and when the threshold is exceeded activating a second set of sensors to obtain a second statistic (e.g. IMU, inertial measurement unit) on the abnormal condition as set forth in Paragraphs [0043] and [0165] to provide further data to identify if the patient is actually experiencing an abnormal condition or experiencing an abnormal sensed signal. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Karow et al, with the in-vivo sensor is at least one of an electrocochleography (ECoG) sensor or an inertial measurement unit as taught by Xu et al, since such a modification would provide the predictable results of further data to identify if the patient is actually experiencing an abnormal condition or experiencing an abnormal sensed signal.
Allowable Subject Matter
Claim 15 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 William J Levicky whose telephone number is (571)270-3983. The examiner can normally be reached Monday-Thursday 8AM-5PM EST.
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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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/William J Levicky/Primary Examiner, Art Unit 3796
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