DETAILED ACTION
The Examiner acknowledges the amendments received 08 December 2025. Claims 1-19 are pending.
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 08 December 2025 have been fully considered but they are not persuasive. The Applicant argues (pages 6-8, “Remarks”) the amendments to the claims. These will be addressed in the prior art rejection
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-3, 5, 9-10, 13-15 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keefe (U.S. 8,241, 224). Keefe discloses (col. 53, lines 29-65) exposing a patient to a window of varying short-duration acoustic activator click rate stimuli to generate a click- evoked otoacoustic emission (CEOAE) occurring in each ear of the patient, wherein the short-duration acoustic activator click rate stimuli are generated via a fist probe and a second probe over a time-course, wherein the time course comprises a plurality of sub-windows (col. 56, lines 5-67), wherein the plurality of sub-windows comprises a baseline sub-window and an activation sub-window, and wherein the activation sub-window comprises the short-duration acoustic activator click rate stimuli, and where in a rate of activator click rate stimuli changes between the baseline sub-window and the activation sub-window; sampling concurrently, via the first probe and the second probe, and in response to exposing the patient to the activator click rate stimuli, an outer hair cell activity (OHC), an efferent activity in each ear of the patient, and a bilateral medial olivocochlear reflex (MOCR) in both ears of the patient simultaneously (col. 40, lines 10-64 and col. 41, lines 22-47, especially “The preferred embodiment measures the double-evoked set of three responses to the two stimuli presented both individually and simultaneously in the same test ear, while a MEMR activator signal is gated on and off. The nonlinear residuals in the presence and absence of the MEMR activator signal may be compared to detect the presence of a MEMR, with either ipsilateral, contralateral or bilateral presentations of the MEMR activator.”); monitoring, via the first probe and the second probe, a middle ear muscle reflex (MEMR) in each ear of the patient in response to exposing the patient to the click rate stimuli (col. 47, line 51-col. 48, line 16); comparing, via a processing device, a CEOAE from the baseline sub-window to a CEOAE from the activation sub-window across the time course to calculate a magnitude of CEOAE, wherein the magnitude of CEOAE is indicative of abnormal cochlear activity of the patient (col. 40, lines 10-64); measuring a change of cochlear activity in the patient based on the magnitude of CEOAE, the efferent activity and the MEMR in each ear of the patient (“The MEMR activator signal may be presented in the same ear as the other acoustic stimulus signals in the case of an ipsilateral MEMR test, or may be presented in the opposite ear as the other acoustic stimulus signals in the case of a contralateral MEMR test, or may be presented in both ears in the case of a bilateral MEMR test.”); and identifying, via the magnitude of CEOAE, the efferent activity, and the MEMR in each ear of the patient an auditory disorder of the patient (Abstract).
Regarding claim 2, Keefe discloses (col. 41, line 57-col. 42, line 3) a rate of the activator click rate stimuli comprises an inter-click interval to allow detection of the CEOAE.
Regarding claim 3, Keefe discloses (col. 47, line 51-col. 48, line 16) a rate of the activator click rate stimuli permits evaluation of auditory efferent function without activating the MEMR.
Regarding claim 5, Keefe discloses (col. 47, line 51-col. 48, line 16) a level of the activator click rate stimuli permits evaluation of auditory efferent function without activating the MEMR.
Regarding claim 9, Keefe discloses (col. 47, line 51-col. 48, line 16) the baseline CEOAE is established by exposing the patient to a baseline activator click stimuli comprising a rate and a level less than a rate and a level of the short-duration acoustic click stimuli.
Regarding claim 10, Keefe discloses (col. 47, line 51-col. 48, line 16) a first set of activator click rate stimuli are used to establish a baseline CEOAE without exposing the patient to a separate baseline activator click stimuli comprising a different rate and a different level than a rate and a level of the activator click stimuli.
Regarding claim 13, Keefe discloses (col. 7, line 57-col. 8, line 8) the auditory disorder is at least middle ear issues.
Regarding claim 14, Keefe discloses (col. 53, lines 29-65) exposing a patient, via a first probe and a second probe, to a window of varying short-duration acoustic activator click rate stimuli to generate a click- evoked otoacoustic emission (CEOAE) occurring in an ear of the patient, wherein the short-duration acoustic activator click rate stimuli are generated over a time-course, wherein the time course comprises a plurality of sub-windows (col. 56, lines 5-67), wherein the plurality of sub-windows comprise a baseline sub-window and an activation sub-window, and wherein the activation sub-window comprise the short-duration acoustic activator click rate stimuli, and wherein a rate of activator click rate stimuli changes between the baseline sub-window and the activation sub-window; in response to exposing the patient to the activator click rate stimuli, concurrently sampling an outer hair cell activity (OHC) via CEOAE, an efferent activity in each ear of the patient, and a bilateral medial olivocochlear reflex (MOCR) in both ears of the patient simultaneously via the change in CEOAE (col. 40, lines 10-64 and col. 41, lines 22-47, especially “The preferred embodiment measures the double-evoked set of three responses to the two stimuli presented both individually and simultaneously in the same test ear, while a MEMR activator signal is gated on and off. The nonlinear residuals in the presence and absence of the MEMR activator signal may be compared to detect the presence of a MEMR, with either ipsilateral, contralateral or bilateral presentations of the MEMR activator.”); monitoring, via the first probe and the second probe, a middle ear muscle reflex (MEMR) in the ear of the patient (col. 47, line 51-col. 48, line 16); comparing, via a processing device, a CEOAE from the baseline sub-window to a CEOAE from the activation sub-window across the time course to calculate a magnitude of CEOAE (col. 40, lines 33-64) wherein the magnitude of CEOAE is indicative of a change in cochlear activity of the patient; identifying via the magnitude of CEOAE, an auditory disorder in the patient (Abstract).
Regarding claim 15, Keefe discloses (col. 47, line 51-col. 48, line 16) a rate of the activator click rate stimuli permits evaluation of auditory efferent function without activating the MEMR.
Regarding claim 19, Keefe discloses (col. 7, line 57-col. 8, line 8) the auditory disorder is at least middle ear issues.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 4, 6 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Keefe (U.S. 8,241, 224). Regarding claims 4 and 17, Keefe discloses the claimed invention except for the rate of the activator click rate stimuli is between 20 and 80 Hz. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a click stimuli rate of this range, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claims 6 and 18, Keefe discloses the claimed invention except for the level of the activator click rate stimuli is between 50 and 100 dB peak-to-peak or peak equivalent sound pressure level (pp or pe SPL). It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a level of the activator clock stimuli of this range, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 16, Keefe discloses the claimed invention except for a rate of the activator click rate stimuli is between 10 and 100 Hz. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide a click stimuli rate of this range, since it has been held that discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
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 DEBORAH L MALAMUD whose telephone number is (571)272-2106. The examiner can normally be reached Mon - Fri 1:00-9:30 Eastern.
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/DEBORAH L MALAMUD/Primary Examiner, Art Unit 3792