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 .
Claims Pending
Applicant's arguments, filed 09/09/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 09/09/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant’s cancellation of claims 3-4 in the response filed 09/09/2025 and previous cancellation of claims 7 and 17-18 is acknowledged.
Claims 1-2, 5-6, 8-16, and 19-20 are the current claims hereby under examination.
Claim Objections
Claim 16 objected to because of the following informalities:
In Claim 16, “having the second audible pitch” (9th to last line), should read “having the second audible pitch;- (Examiner's Note: the inclusion of a semicolon punctuation mark),
Appropriate correction is required.
Claim Interpretation - Withdrawn
Applicant’s amendments, filed 06/18/2024, have been fully considered, and the previous interpretation withdrawn.
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 2, 15, and 20 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 2 recites the limitation “synchronize the presentation of the acoustic feedback and the display of the graph such that the acoustic feedback and the graph indicate the amplitude change at substantially the same time”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what “acoustic feedback” is being referred to. For example, claim 1, which claim 2 is dependent on, recites “the acoustic feedback comprising one or more of the plurality of audible pitches and that audibly indicates the amplitude change” while also reciting “additional acoustic feedback that is distinct from the acoustic feedback and that does not include any of the plurality of audible pitches, the additional acoustic feedback audibly indicating an occurrence of the event, wherein the presenting the additional acoustic feedback is performed concurrently with the presenting the acoustic feedback.”. Is this claim referring to the “additional acoustic feedback”, the acoustic feedback with the plurality audible pitches, or both types of acoustic feedback. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the acoustic feedback that is NOT the “additional acoustic feedback”.
Claim 15 recites the limitation “wherein the processor is further configured to execute the instructions to use multi-rate analysis to detect the amplitude change and present the acoustic feedback”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what “acoustic feedback” is being referred to. For example, claim 1, which claim 15 is dependent on, recites “the acoustic feedback comprising one or more of the plurality of audible pitches and that audibly indicates the amplitude change” while also reciting “additional acoustic feedback that is distinct from the acoustic feedback and that does not include any of the plurality of audible pitches, the additional acoustic feedback audibly indicating an occurrence of the event, wherein the presenting the additional acoustic feedback is performed concurrently with the presenting the acoustic feedback.”. Is this claim referring to the “additional acoustic feedback”, the acoustic feedback with the plurality audible pitches, or both types of acoustic feedback. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the acoustic feedback that is NOT the “additional acoustic feedback”.
Claim 20 recites the limitation “synchronizing the presentation of the acoustic feedback and the display of the graph such that the acoustic feedback and the graph indicate the amplitude change at substantially the same time”, which fails to effectively define the metes and bounds of the claim as it is unclear as to what “acoustic feedback” is being referred to. For example, claim 19, which claim 20 is dependent on, recites “the audible pitches for acoustic feedback to be presented to audibly indicate a change in amplitude of the evoked responses elicited by the acoustic stimulation” while also reciting “additional acoustic feedback that is distinct from the acoustic feedback and that does not include any of the plurality of audible pitches, the additional acoustic feedback audibly indicating an occurrence of the event, wherein the presenting the additional acoustic feedback is performed concurrently with the presenting the acoustic feedback.”. Is this claim referring to the “additional acoustic feedback”, the acoustic feedback with the plurality audible pitches, or both types of acoustic feedback. As such, the claim is indefinite as the applicant has failed to effectively define the metes and bounds of the claim. For examination purposes, this will be interpreted as the acoustic feedback that is NOT the “additional acoustic feedback”.
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 claims are generally directed towards a system for monitoring evoked responses that includes a memory storing instructions and a processor configured to execute the instructions. The instructions include determining evoked response amplitudes for a recipient of a cochlear implant in response to acoustic stimulation, mapping a plurality of audible pitches to the measured evoked response, and presenting acoustic feedback that comprises the audible pitches.
Claim(s) 1-2, 5-6, 8-13, 16, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koka (WIPO Pub. No. 2017/131675 A1) hereinafter Koka, and further in view of Kaufman (US Pub. No. 20200337725) hereinafter Kaufman.
Regarding claim 1, Koka discloses A system (abstract) comprising:
a memory storing instructions (Par. 93 (memory with instructions));
a processor (sound processor – 104) communicatively coupled to the memory (Par. 93 (processor receives instructions)) and configured to execute the instructions to:
determine a minimum evoked response amplitude and a maximum evoked response amplitude (Par. 55 (graph with amplitudes of evoked responses, which contains both a maximum and minimum)(Fig. 14, (observable amplitude changes in graph 1402))) for a recipient of a cochlear implant (abstract (during implantation of a cochlear implant)), the minimum and maximum evoked response amplitudes associated with evoked responses elicited by acoustic stimulation applied to the recipient (Par. 55 (graph with amplitudes of evoked responses, which contains both a maximum and minimum)(Fig. 14, (observable amplitude changes in graph 1402))) (Claim 1 (evoked responses in response to acoustic stimulation));
monitor (claim 1), during an insertion procedure in which an electrode lead communicatively coupled to the cochlear implant is inserted into a cochlea of the recipient (Claim 1), an evoked response signal (Par. 54, “signals representative of the evoked responses as detected and sent by intracochlear electrode 1 12-1 . The signals detected and sent by intracochlear electrode 1 12-1 may be analog signals”) recorded during the insertion procedure by an electrode disposed on the electrode lead (Claim 1), the evoked response signal representing amplitudes of a plurality of evoked responses (Par. 55 (graph with amplitudes of evoked responses)(Fig. 14, (observable amplitude changes in graph 1402))) that occur within the recipient (Par. 48, “extracochlear electrode 702 may facilitate monitoring of evoked responses from within the cochlea by intracochlear electrode”) in response to the acoustic stimulation applied to the recipient (Par. 54, “in response to the acoustic stimulation”)(Claim 1);
detect an amplitude change in the evoked response signal as the evoked response signal is being monitored (Par. 44 (detection of changes in amplitude)).
Koka fails to explicitly disclose determine a mapping between a plurality of audible pitches and a plurality of evoked response amplitudes included in a range defined by the minimum and maximum evoked response amplitudes, the audible pitches for acoustic feedback to be presented to audibly indicate a change in amplitude of the evoked responses elicited by the acoustic stimulation, the determining the mapping comprising: mapping a lowest audible pitch within the plurality of audible pitches to the minimum evoked response amplitude, mapping a highest audible pitch within the plurality of audible pitches to the maximum evoked response amplitude, and mapping one or more audible pitches within the plurality of audible pitches other than the lowest and highest audible pitches to different evoked response amplitudes that are in between the minimum and maximum evoked response amplitudes.
However, Koka does teach a graphical representation of a range of evoked response amplitudes that include minimum and maximum evoked response amplitudes and a change in amplitude of the evoked responses elicited by the acoustic stimulation (Par. 55 (graph with amplitudes of evoked responses)(Fig. 14, (observable amplitude changes in graph 1402))) (Par. 57, “a first evoked response at a first insertion depth of intracochlear electrode 1 12-1 and a second evoked response at a second insertion depth of intracochlear electrode” (the range is between the first and second evoked responses, one of which is a minimum and the other is the maximum, as seen in Fig. 9, where the first evoked response 906-1 at depth 812-1 has a higher amplitude than the second evoked response 906-2 at depth 812-2)) (Claim 1 (evoked responses in response to acoustic stimulation)).
Kaufman teaches determine a mapping between a plurality of audible pitches and a plurality of amplitudes included in a range defined by the minimum and maximum amplitudes (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (the furthest distance away from the target site is the lowest) (highest level at the target site) (gradually increases between the start and the target site)), the audible pitches for acoustic feedback to be presented to audibly indicate a change in amplitude (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit”), the determining the mapping comprising:
mapping a lowest audible pitch within the plurality of audible pitches to the minimum amplitude (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target site”, (the furthest distance away from the target site is the lowest)), mapping a highest audible pitch within the plurality of audible pitches to the maximum amplitude (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (highest level at the target site)), and mapping one or more audible pitches within the plurality of audible pitches other than the lowest and highest audible pitches to different amplitudes that are in between the minimum and maximum amplitudes (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (gradually increases between the start and the target site)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Koka with that of Kaufman to include determine a mapping between a plurality of audible pitches and a plurality of evoked response amplitudes of Koka included in a range defined by the minimum and maximum evoked response amplitudes of Koka, the audible pitches for acoustic feedback to be presented to audibly indicate a change in amplitude of the evoked responses of Koka elicited by the acoustic stimulation of Koka, the determining the mapping comprising: mapping a lowest audible pitch within the plurality of audible pitches to the minimum evoked response amplitude of Koka, mapping a highest audible pitch within the plurality of audible pitches to the maximum evoked response amplitude of Koka, and mapping one or more audible pitches within the plurality of audible pitches other than the lowest and highest audible pitches to different evoked response amplitudes of Koka that are in between the minimum and maximum evoked response amplitudes of Koka through the combination of references and substituting the visual output of Koka for the auditory feedback of Kaufman (Kaufman (Par. 97)) and it would have yielded the predictable result of directly providing the surgeon with auditory feedback during the implantation procedure (Kaufman (Par. 97)).
Modified Koka fails to explicitly disclose present, based on the mapping and as the evoked response signal is being monitored, the acoustic feedback comprising one or more of the plurality of audible pitches and that audibly indicates the amplitude change.
However, Koka does disclose as the evoked response signal being monitored (Par. 55 (graph with amplitudes of evoked responses)(Fig. 14, (observable amplitude changes in graph 1402))) (Par. 57, (evoked response)).
Kaufman further teaches present, based on the mapping, the acoustic feedback comprising one or more of the plurality of audible pitches and that audibly indicates the amplitude change (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (audible pitches presented to the surgeon)).
Koka and Kaufman are considered to be analogous art to the claimed invention as they are involved with cochlear devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Koka and Kaufman with that of Kaufman to include present, based on the mapping and as the evoked response signal of Koka is being monitored, the acoustic feedback comprising one or more of the plurality of audible pitches and that audibly indicates the amplitude change through the combination of references as it would have yielded the predictable result of directly providing the surgeon with auditory feedback during the implantation procedure (Kaufman (Par. 97)).
Modified Koka fails to explicitly disclose determine that the amplitude change occurs within a particular time period and is greater than an event threshold associated with an event; and present, in response to the amplitude change occurring within the particular time period and being greater than the event threshold, additional acoustic feedback that is distinct from the acoustic feedback and that does not include any of the plurality of audible pitches, the additional acoustic feedback audibly indicating an occurrence of the event, wherein the presenting the additional acoustic feedback is performed concurrently with the presenting the acoustic feedback.
However, Koka does disclose determine that the amplitude change occurs within a particular time period and is greater than an event threshold associated with an event (Par. 44 (cochlear trauma detected based on changes greater than a threshold)) (Par. 45 (occurrence of trauma)); and
present, in response to the amplitude change occurring within the particular time period and being greater than the event threshold (Par. 45 (trauma)) (Par. 57, (audible sound)), additional acoustic feedback (Par. 57, (alarm)), the additional acoustic feedback audibly indicating an occurrence of the event (Par. 57, “cochlear trauma has likely occurred at the second insertion depth of the intracochlear electrode within the cochlea. Based on these determinations, monitoring system 600 may notify (e.g., by an audible sound, a visible warning light, a message displayed on a graphical user interface presented by programming system 402, etc.) a user of monitoring system 600 that cochlear trauma has likely occurred at the second insertion depth of the intracochlear electrode within the cochlea.”), wherein the presenting the additional acoustic feedback is performed concurrently with the presenting the feedback (Par. 57 (audible sound during the monitoring that is distinct from the graphical monitoring)) (Par. 55 (graph with amplitudes of evoked responses)).
Kaufman further teaches feedback that is distinct from the acoustic feedback and that does not include any of the plurality of audible pitches (Par. 97, “A beep or an alarm with a different tone or different pattern can alert an excessive force imposed on the implant.”) (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit”), wherein the presenting the additional feedback is performed concurrently with the presenting the acoustic feedback (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (excessive force alarm is present along with the acoustic feedback in real time)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Koka and Kaufman with that of Kaufman to include determine that the amplitude change occurs within a particular time period and is greater than an event threshold associated with an event of Koka; and present, in response to the amplitude change occurring within the particular time period and being greater than the event threshold of Koka, additional acoustic feedback of Koka that is distinct from the acoustic feedback of Kaufman and that does not include any of the plurality of audible pitches of Kaufman, the additional acoustic feedback of Koka audibly indicating an occurrence of the event, wherein the presenting the additional acoustic feedback of Koka is performed concurrently with the presenting the acoustic feedback of Kaufman through the combination of references as it would have yielded the predictable result of directly providing the surgeon with auditory feedback during the implantation procedure (Kaufman (Par. 97)) and providing special feedback to the surgeon regarding cochlear trauma (Koka (Par. 20)).
Regarding claim 2, modified Koka further discloses wherein the processor is further configured to execute the instructions to:
direct a display screen to display a graph of the evoked response signal that graphically indicates the amplitude change (Par. 51) (Par. 92, graph 1402, system -402) (Fig. 14, (observable amplitude changes in graph 1402)); and
Modified Koka fails to explicitly disclose synchronize the presentation of the acoustic feedback and the display of the graph such that the acoustic feedback and the graph indicate the amplitude change at substantially the same time.
However, Kaufman further teaches synchronize the presentation of the acoustic feedback and the display of the graph such that the acoustic feedback and the graph indicate the amplitude change at substantially the same time (Par. 97, “The presentation can include real-time visual or audible notification with specified patterns corresponding to different…” “…The output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern (e.g., continuous, intermittent, pulsed, sweep-up, or sweep-down sound)” (both visual and audible presentation of the data)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Koka and Kaufman with that of Kaufman to include synchronize the presentation of the acoustic feedback and the display of the graph such that the acoustic feedback and the graph indicate the amplitude change at substantially the same time through the combination of references as it would have yielded the predictable result of providing both audible and visual feedback (Kaufman (Par. 97))
Regarding claim 5, modified Koka further discloses wherein the processor is further configured to execute the instructions to:
present a graphical user interface by way of a display screen (Par. 51); and
detect user input provided by way of the graphical user interface (Par. 51) and that specifies the event threshold (Par. 68, “a change 908 between first evoked response 906-1 and second evoked response 906-2 is greater than a predetermined threshold (e.g., 0 uV, 1 uV, 10 uV, etc.),”).
Regarding claim 6, modified Koka further discloses the processor (Par. 97 (processor)) is further configured to execute the instructions to present a graphical user interface by way of a display screen (Par. 51 (programming system -402 includes the processor)); and
the determining of the minimum and maximum evoked response amplitudes comprises detecting user input provided by way of the graphical user interface and representative of the minimum and maximum evoked response amplitudes.
Regarding claim 8, modified Koka further discloses wherein the audible pitches are musically related to each other (Par. 53 (one or more tones)).
Regarding claim 9, modified Koka further discloses wherein the processor (system – 402) (Par. 93) is further configured to execute the instructions to:
direct an acoustic stimulation generator (loudspeaker – 302) to apply the acoustic stimulation (Par. 33, 45); and
direct the cochlear implant to use the electrode to record the evoked response signal (Par. 45, “intracochlear electrode (e.g., one of intracochlear electrodes 1 12) with an extracochlear electrode, receive evoked responses detected and sent by the shorted intracochlear electrode by way of the extracochlear electrode and a probe, convert signals representative of evoked responses from analog signals into digital signals, record signals representative of evoked responses (e.g., digital signals that have been converted from analog signals recorded by the intracochlear electrode),”).
Regarding claim 10, modified Koka further discloses wherein the processor is included in a computing module (Fig. 5, computing device - 502) of a stand-alone diagnostic system (abstract (monitoring system)); and
the acoustic stimulation generator (loudspeaker – 302) comprises an interface unit included in a base module configured to be attached to the computing module (Par. 33, “sound processor 104 (which, in implementation 300, may be referred to as an "EAS sound processor") may be configured to direct loudspeaker 302 to apply acoustic stimulation representative of audio content to one or more stimulation sites within the patient”) (Par. 38, “programming system 402 may provide one or more graphical user interfaces ("GUIs") (e.g., by presenting the one or more GUIs by way of a display screen) with which a clinician or other user may interact.”).
Regarding claim 11, modified Koka further discloses wherein the acoustic stimulation generator is implemented by a behind-the-ear bimodal sound processor comprising an audio earhook (Par. 24, 25).
Regarding claim 12, modified Koka further discloses wherein the evoked responses are ECochG potentials (Par. 2, 21).
Regarding claim 13, modified Koka further discloses wherein the processor is further configured to execute the instructions to:
present a graphical user interface by way of a display screen (Claim 13);
detect a selection of a start option displayed within the graphical user interface (Claim 13 (user input command)); and
begin the monitoring of the evoked response signal in response to the selection of the start option (Claim 13 (user input command that begins monitoring)).
Regarding claim 16, Koka discloses A system (abstract) comprising:
a memory storing instructions (Par. 93 (memory with instructions));
a processor (sound processor – 104) communicatively coupled to the memory (Par. 93 (processor receives instructions)) and configured to execute the instructions to:
detect (claim 1), during an insertion procedure in which an electrode lead is inserted by a user into the cochlea of the recipient (Claim 1), a first evoked response having the first evoked response amplitude (Par. 55 (graph with amplitudes of evoked responses)(Fig. 14, (observable amplitude changes in graph 1402))) (Par. 57 (first evoked response)), the first evoked response occurring in response to the acoustic stimulation applied to the recipient at a first time (Par. 55) (Par. 88, “During insertion procedure 1200, monitoring system 600 may monitor evoked responses that occur within cochlea 802 in response to the acoustic stimulation produced at the particular frequency (e.g., the relatively high frequency encoded by auditory nerve tissue located at high frequency target depth 1202). More specifically, monitoring system 600 may use intracochlear electrode 1 12-1 to measure a first evoked response at a first insertion depth 1204-1 and a second evoked response at a second insertion depth 1204-2.”);
detect (Claim 1), during the insertion procedure (Claim 1), a second evoked response having the second evoked response amplitude and based on the mapping (Par. 55 (graph with amplitudes of evoked responses)(Fig. 14, (observable amplitude changes in graph 1402))) (Par. 57 (second evoked response)), the second evoked response occurring in response to the acoustic stimulation applied to the recipient at a second time (Par. 55) (Par. 88, “During insertion procedure 1200, monitoring system 600 may monitor evoked responses that occur within cochlea 802 in response to the acoustic stimulation produced at the particular frequency (e.g., the relatively high frequency encoded by auditory nerve tissue located at high frequency target depth 1202). More specifically, monitoring system 600 may use intracochlear electrode 1 12-1 to measure a first evoked response at a first insertion depth 1204-1 and a second evoked response at a second insertion depth 1204-2.”).
Modified Koka fails to explicitly disclose determine a mapping between a plurality of audible pitches and a plurality of evoked response amplitudes, the mapping specifying that a first audible pitch included in the plurality of audible pitches is mapped to a first evoked response amplitude included in the plurality of evoked response amplitudes, that a second audible pitch included in the plurality of audible pitches is mapped to a second evoked response amplitude included in the plurality of evoked response amplitudes, and that one or more audible pitches within the plurality of audible pitches other than the first and second audible pitches are mapped to different evoked response amplitudes that are in between the first and second evoked response amplitudes, the first and second evoked response amplitudes associated with evoked responses elicited by acoustic stimulation applied to a recipient, the audible pitches for acoustic feedback to be presented to audibly indicate a change in amplitude of the evoked responses elicited by the acoustic stimulation.
However, Koka does teach a graphical representation of a range of evoked response amplitudes that include first and second evoked response amplitudes, the first and second amplitudes associated with evoked responses elicited by acoustic stimulation applied to a recipient, and a change in amplitude of the evoked responses elicited by the acoustic stimulation (Par. 55 (graph with amplitudes of evoked responses)(Fig. 14, (observable amplitude changes in graph 1402))) (Par. 57, “a first evoked response at a first insertion depth of intracochlear electrode 1 12-1 and a second evoked response at a second insertion depth of intracochlear electrode” (the range is between the first and second evoked responses, one of which is a minimum and the other is the maximum, as seen in Fig. 9, where the first evoked response 906-1 at depth 812-1 has a higher amplitude than the second evoked response 906-2 at depth 812-2)) (Claim 1 (evoked responses in response to acoustic stimulation)).
Kaufman teaches determine a mapping between a plurality of audible pitches and a plurality of amplitudes (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (the furthest distance away from the target site is the lowest) (highest level at the target site) (gradually increases between the start and the target site)), the mapping specifying that a first audible pitch included in the plurality of audible pitches is mapped to a first amplitude included in the plurality of amplitudes (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target site”, (the furthest distance away from the target site is the lowest)), that a second audible pitch included in the plurality of audible pitches is mapped to a second amplitude included in the plurality of amplitudes (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (highest level at the target site)), and that one or more audible pitches within the plurality of audible pitches other than the first and second audible pitches are mapped to different amplitudes that are in between the first and second amplitudes (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (gradually increases between the start and the target site)), the audible pitches for acoustic feedback to be presented to audibly indicate a change in amplitude (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit”).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Koka with that of Kaufman to include determine a mapping between a plurality of audible pitches and a plurality of evoked response amplitudes of Koka, the mapping specifying that a first audible pitch included in the plurality of audible pitches is mapped to a first evoked response amplitude of Koka included in the plurality of evoked response amplitudes Koka, that a second audible pitch included in the plurality of audible pitches is mapped to a second evoked response amplitude of Koka included in the plurality of evoked response amplitudes of Koka, and that one or more audible pitches within the plurality of audible pitches other than the first and second audible pitches are mapped to different evoked response amplitudes of Koka that are in between the first and second evoked response amplitudes, the first and second evoked response amplitudes associated with evoked responses of Koka elicited by acoustic stimulation of Koka applied to a recipient, the audible pitches for acoustic feedback to be presented to audibly indicate a change in amplitude of the evoked responses of Koka elicited by the acoustic stimulation of Koka through the combination of references and substituting the visual output of Koka for the auditory feedback of Kaufman (Kaufman (Par. 97)) and it would have yielded the predictable result of directly providing the surgeon with auditory feedback during the implantation procedure (Kaufman (Par. 97)).
Modified Koka fails to explicitly disclose present, to the user in response to the detection of the first evoked response and based on the mapping, the acoustic feedback having the first audible pitch.
However, Koka does disclose the first evoked response (Par. 55 (graph with amplitudes of evoked responses)(Fig. 14, (observable amplitude changes in graph 1402))) (Par. 57, (evoked response)).
Kaufman further teaches present, to the user in response to the detection of the first response and based on the mapping, the acoustic feedback having the first audible pitch (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (acoustic feedback at the distance furthest from the target site)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Koka and Kaufman with that of Kaufman to include present, to the user in response to the detection of the first evoked response of Koka and based on the mapping, the acoustic feedback having the first audible pitch through the combination of references as it would have yielded the predictable result of directly providing the surgeon with auditory feedback during the implantation procedure (Kaufman (Par. 97)).
Modified Koka fails to explicitly disclose present, to the user in response to the detection of the second evoked response, the acoustic feedback comprising one or more of the plurality of audible pitches and having the second audible pitch.
However, Koka does disclose the second evoked response (Par. 55 (graph with amplitudes of evoked responses)(Fig. 14, (observable amplitude changes in graph 1402))) (Par. 57, (evoked response)).
Kaufman further teaches present, to the user in response to the detection of the second response, the acoustic feedback comprising one or more of the plurality of audible pitches and having the second audible pitch (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (pitches in between the first and second)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Koka and Kaufman with that of Kaufman to include present, to the user in response to the detection of the second evoked response of Koka, the acoustic feedback comprising one or more of the plurality of audible pitches and having the second audible pitch through the combination of references as it would have yielded the predictable result of directly providing the surgeon with auditory feedback during the implantation procedure (Kaufman (Par. 97)).
Modified Koka fails to explicitly disclose determine that the amplitude change occurs within a particular time period and is greater than an event threshold associated with an event; and present, in response to the amplitude change occurring within the particular time period and being greater than the event threshold, additional acoustic feedback that is distinct from the acoustic feedback and that does not include any of the plurality of audible pitches, the additional acoustic feedback audibly indicating an occurrence of the event, wherein the presenting the additional acoustic feedback is performed concurrently with the presenting the acoustic feedback.
However, Koka does disclose determine that the amplitude change occurs within a particular time period and is greater than an event threshold associated with an event (Par. 44 (cochlear trauma detected based on changes greater than a threshold)) (Par. 45 (occurrence of trauma)); and
present, in response to the amplitude change occurring within the particular time period and being greater than the event threshold (Par. 45 (trauma)) (Par. 57, (audible sound)), additional acoustic feedback (Par. 57, (alarm)), the additional acoustic feedback audibly indicating an occurrence of the event (Par. 57, “cochlear trauma has likely occurred at the second insertion depth of the intracochlear electrode within the cochlea. Based on these determinations, monitoring system 600 may notify (e.g., by an audible sound, a visible warning light, a message displayed on a graphical user interface presented by programming system 402, etc.) a user of monitoring system 600 that cochlear trauma has likely occurred at the second insertion depth of the intracochlear electrode within the cochlea.”), wherein the presenting the additional acoustic feedback is performed concurrently with the presenting the feedback (Par. 57 (audible sound during the monitoring that is distinct from the graphical monitoring)) (Par. 55 (graph with amplitudes of evoked responses)).
Kaufman further teaches feedback that is distinct from the acoustic feedback and that does not include any of the plurality of audible pitches (Par. 97, “A beep or an alarm with a different tone or different pattern can alert an excessive force imposed on the implant.”) (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit”), wherein the presenting the additional feedback is performed concurrently with the presenting the acoustic feedback (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (excessive force alarm is present along with the acoustic feedback in real time)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Koka and Kaufman with that of Kaufman to include determine that the amplitude change occurs within a particular time period and is greater than an event threshold associated with an event of Koka; and present, in response to the amplitude change occurring within the particular time period and being greater than the event threshold of Koka, additional acoustic feedback of Koka that is distinct from the acoustic feedback of Kaufman and that does not include any of the plurality of audible pitches of Kaufman, the additional acoustic feedback of Koka audibly indicating an occurrence of the event, wherein the presenting the additional acoustic feedback of Koka is performed concurrently with the presenting the acoustic feedback of Kaufman through the combination of references as it would have yielded the predictable result of directly providing the surgeon with auditory feedback during the implantation procedure (Kaufman (Par. 97)) and providing special feedback to the surgeon regarding cochlear trauma (Koka (Par. 20)).
Regarding claim 19, Koka discloses a method comprising:
determining, by a diagnostic system (abstract), a minimum evoked response amplitude and a maximum evoked response amplitude (Par. 55 (graph with amplitudes of evoked responses, which contains both a maximum and minimum)(Fig. 14, (observable amplitude changes in graph 1402))) for a recipient of a cochlear implant (abstract (during implantation of a cochlear implant)), the minimum and maximum evoked response amplitudes associated with evoked responses elicited by acoustic stimulation applied to the recipient (Par. 55 (graph with amplitudes of evoked responses, which contains both a maximum and minimum)(Fig. 14, (observable amplitude changes in graph 1402))) (Claim 1 (evoked responses in response to acoustic stimulation));
monitoring (Claim 1), by the diagnostic system during an insertion procedure in which an electrode lead communicatively coupled to the cochlear implant is inserted into a cochlea of the recipient (Claim 1), an evoked response signal (Par. 54, “signals representative of the evoked responses as detected and sent by intracochlear electrode 1 12-1 . The signals detected and sent by intracochlear electrode 1 12-1 may be analog signals”) recorded during the insertion procedure by an electrode disposed on the electrode lead (Claim 1), the evoked response signal representing amplitudes of a plurality of evoked responses (Par. 55 (graph with amplitudes of evoked responses)(Fig. 14, (observable amplitude changes in graph 1402))) that occur within the recipient (Par. 48, “extracochlear electrode 702 may facilitate monitoring of evoked responses from within the cochlea by intracochlear electrode”) in response to the acoustic stimulation applied to the recipient (Par. 54, “in response to the acoustic stimulation”) (Claim 1);
detecting, by the diagnostic system, an amplitude change in the evoked response signal as the evoked response signal is being monitored (Par. 44 (detection of changes in amplitude)).
Koka fails to explicitly disclose determining, by the diagnostic system, a mapping between a plurality of audible pitches and a plurality of evoked response amplitudes included in a range defined by the minimum and maximum evoked response amplitudes, the audible pitches for acoustic feedback to be presented to audibly indicate a change in amplitude of the evoked responses elicited by the acoustic stimulation, the determining the mapping comprising: mapping a lowest audible pitch within the plurality of audible pitches to the minimum evoked response amplitude, mapping a highest audible pitch within the plurality of audible pitches to the maximum evoked response amplitude, and mapping one or more audible pitches within the plurality of audible pitches other than the lowest and highest audible pitches to different evoked response amplitudes that are in between the minimum and maximum evoked response amplitudes.
However, Koka does teach a graphical representation of a range of evoked response amplitudes that include minimum and maximum evoked response amplitudes and a change in amplitude of the evoked responses elicited by the acoustic stimulation (Par. 55 (graph with amplitudes of evoked responses)(Fig. 14, (observable amplitude changes in graph 1402))) (Par. 57, “a first evoked response at a first insertion depth of intracochlear electrode 1 12-1 and a second evoked response at a second insertion depth of intracochlear electrode” (the range is between the first and second evoked responses, one of which is a minimum and the other is the maximum, as seen in Fig. 9, where the first evoked response 906-1 at depth 812-1 has a higher amplitude than the second evoked response 906-2 at depth 812-2)) (Claim 1 (evoked responses in response to acoustic stimulation)).
Kaufman teaches determining, by the diagnostic system, a mapping between a plurality of audible pitches and a plurality of amplitudes included in a range defined by the minimum and maximum amplitudes (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (the furthest distance away from the target site is the lowest) (highest level at the target site) (gradually increases between the start and the target site)), the audible pitches for acoustic feedback to be presented to audibly indicate a change in amplitude (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit”), the determining the mapping comprising:
mapping a lowest audible pitch within the plurality of audible pitches to the minimum amplitude (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target site”, (the furthest distance away from the target site is the lowest)), mapping a highest audible pitch within the plurality of audible pitches to the maximum amplitude (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (highest level at the target site)), and mapping one or more audible pitches within the plurality of audible pitches other than the lowest and highest audible pitches to different amplitudes that are in between the minimum and maximum amplitudes (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (gradually increases between the start and the target site)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Koka with that of Kaufman to include determining, by the diagnostic system, a mapping between a plurality of audible pitches and a plurality of evoked response amplitudes of Koka included in a range defined by the minimum and maximum evoked response amplitudes of Koka, the audible pitches for acoustic feedback to be presented to audibly indicate a change in amplitude of the evoked responses of Koka elicited by the acoustic stimulation of Koka, the determining the mapping comprising: mapping a lowest audible pitch within the plurality of audible pitches to the minimum evoked response amplitude of Koka, mapping a highest audible pitch within the plurality of audible pitches to the maximum evoked response amplitude of Koka, and mapping one or more audible pitches within the plurality of audible pitches other than the lowest and highest audible pitches to different evoked response amplitudes of Koka that are in between the minimum and maximum evoked response amplitudes of Koka through the combination of references and substituting the visual output of Koka for the auditory feedback of Kaufman (Kaufman (Par. 97)) and it would have yielded the predictable result of directly providing the surgeon with auditory feedback during the implantation procedure (Kaufman (Par. 97)).
Modified Koka fails to explicitly disclose presenting, by the diagnostic system based on the mapping and as the evoked response signal is being monitored, the acoustic feedback comprising one or more of the plurality of audible pitches and that audibly indicates the amplitude change.
However, Koka does disclose as the evoked response signal being monitored (Par. 55 (graph with amplitudes of evoked responses)(Fig. 14, (observable amplitude changes in graph 1402))) (Par. 57, (evoked response)).
However, Kaufman further teaches presenting, by the diagnostic system based on based on the mapping, the acoustic feedback comprising one or more of the plurality of audible pitches and that audibly indicates the amplitude change (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (audible pitches presented to the surgeon)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Koka and Kaufman with that of Kaufman to include presenting, by the diagnostic system based on the mapping and as the evoked response signal of Koka is being monitored, the acoustic feedback comprising one or more of the plurality of audible pitches and that audibly indicates the amplitude change through the combination of references as it would have yielded the predictable result of directly providing the surgeon with auditory feedback during the implantation procedure (Kaufman (Par. 97)).
Modified Koka fails to explicitly disclose determining, by the diagnostic system, that the amplitude change occurs within a particular time period and is greater than an event threshold associated with an event; and presenting, by the diagnostic system in response to the amplitude change occurring within the particular time period and being greater than the event threshold, additional acoustic feedback that is distinct from the acoustic feedback and that does not include any of the plurality of audible pitches, the additional acoustic feedback audibly indicating an occurrence of the event, wherein the presenting the additional acoustic feedback is performed concurrently with the presenting the acoustic feedback.
However, Koka does disclose determining, by the diagnostic system (abstract), that the amplitude change occurs within a particular time period and is greater than an event threshold associated with an event (Par. 44 (cochlear trauma detected based on changes greater than a threshold)) (Par. 45 (occurrence of trauma)); and
presenting, by the diagnostic system (Abstract) in response to the amplitude change occurring within the particular time period and being greater than the event threshold (Par. 45 (trauma)) (Par. 57, (audible sound)), additional acoustic feedback (Par. 57, (alarm)), the additional acoustic feedback audibly indicating an occurrence of the event (Par. 57, “cochlear trauma has likely occurred at the second insertion depth of the intracochlear electrode within the cochlea. Based on these determinations, monitoring system 600 may notify (e.g., by an audible sound, a visible warning light, a message displayed on a graphical user interface presented by programming system 402, etc.) a user of monitoring system 600 that cochlear trauma has likely occurred at the second insertion depth of the intracochlear electrode within the cochlea.”), wherein the presenting the additional acoustic feedback is performed concurrently with the presenting the feedback (Par. 57 (audible sound during the monitoring that is distinct from the graphical monitoring)) (Par. 55 (graph with amplitudes of evoked responses)).
Kaufman further teaches acoustic feedback that is distinct from the acoustic feedback and that does not include any of the plurality of audible pitches (Par. 97, “A beep or an alarm with a different tone or different pattern can alert an excessive force imposed on the implant.”) (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit”), wherein the presenting the additional feedback is performed concurrently with the presenting the acoustic feedback (Par. 97, “output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern…” “…The sound frequency or the pulse rate of the beep or the alarm can increase as the implant gets closer and finally reaches the target sit” (excessive force alarm is present along with the acoustic feedback in real time)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Koka and Kaufman with that of Kaufman to include determining, by the diagnostic system, that the amplitude change occurs within a particular time period and is greater than an event threshold associated with an event of Koka; and presenting, by the diagnostic system in response to the amplitude change occurring within the particular time period and being greater than the event threshold of Koka, additional acoustic feedback of Koka that is distinct from the acoustic feedback of Kaufman and that does not include any of the plurality of audible pitches of Kaufman, the additional acoustic feedback of Koka audibly indicating an occurrence of the event, wherein the presenting the additional acoustic feedback of Koka is performed concurrently with the presenting the acoustic feedback of Kaufman through the combination of references as it would have yielded the predictable result of directly providing the surgeon with auditory feedback during the implantation procedure (Kaufman (Par. 97)) and providing special feedback to the surgeon regarding cochlear trauma (Koka (Par. 20)).
Regarding claim 20, modified Koka further discloses directing a display screen to display a graph of the evoked response signal that graphically indicates the amplitude change(Par. 51) (Par. 92, graph 1402, system -402) (Fig. 14, (observable amplitude changes in graph 1402)).
Modified Koka fails to explicitly disclose synchronizing the presentation of the acoustic feedback and the display of the graph such that the acoustic feedback and the graph indicate the amplitude change at substantially the same time.
However, Kaufman teaches synchronizing the presentation of the acoustic feedback and the display of the graph such that the acoustic feedback and the graph indicate the amplitude change at substantially the same time (Par. 97, “The presentation can include real-time visual or audible notification with specified patterns corresponding to different…” “…The output module 126 can additionally or alternatively include an audio indicator, such as a beep with a specific tone, a specific frequency, or a specific pattern (e.g., continuous, intermittent, pulsed, sweep-up, or sweep-down sound)” (both visual and audible presentation of the data)).
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the method of Koka and Kaufman with that of Kaufman to include synchronizing the presentation of the acoustic feedback and the display of the graph such that the acoustic feedback and the graph indicate the amplitude change at substantially the same time through the combination of references as it would have yielded the predictable result of providing both audible and visual feedback (Kaufman (Par. 97)).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koka in view of Kaufman as applied to claim 13 above, and further in view of Kabot (US Pub. No. 20150314122) hereinafter Kabot.
Koka and Kaufman teach the system of claim 13 above.
Regarding claim 14, modified Koka fails to explicitly disclose the limitations of the claim.
However, Kabot teaches measure an impedance of the electrode in response to the selection of the start option (abstract); and
abstain from beginning to monitor the evoked response signal until the impedance of the electrode is below a predetermined threshold (Par. 10).
Koka, Kaufman, and Kabot are considered to be analogous art to the claimed invention as they are involved with cochlear devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Koka and Kaufman with that of Kabot to include measure an impedance of the electrode in response to the selection of the start option; and abstain from beginning to monitor the evoked response signal until the impedance of the electrode is below a predetermined threshold through the combination of references as it would have yielded the predictable result of ensuring that the electrodes are in the optimal location within the cochlea (Kabot (Par. 10)).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koka in view of Kaufman as applied to claim 1 above, and further in view of Yip (US Pub. No. 20160287870) hereinafter Yip.
Koka and Kaufman teach the system of claim 1 above.
Regarding claim 15, modified Koka further discloses wherein the processor is further configured to execute the instructions to use analysis to detect the amplitude change and present the acoustic feedback (Par. 57 “may determine that a change between the first evoked response and the second evoked response…” “…may notify (e.g., by an audible sound, a visible warning light, a message displayed on a graphical user interface presented by programming system 402”).
Koka fails to explicitly disclose multi-rate analysis.
However, Yip teaches use multi-rate analysis (Par. 86).
Koka, Kaufman, and Yip are considered to be analogous art to the claimed invention as they are involved with cochlear devices.
Therefore, it would have been obvious to a person of ordinary skill in the art to modify the system of Koka and Kaufman with that of Yip to include use multi-rate analysis to detect the amplitude change and present the acoustic feedback through the combination of references as it would have yielded the predictable result of decreasing excess power consumption by the device (Yip (Par. 86)).
Response to Arguments
Applicant’s arguments, filed 09/09/2025, regarding the previous 103 rejection have been fully considered and deemed as not persuasive.
The applicant's argument, that the prior art does not teach the added limitations to claim, have been fully considered and deemed as not persuasive. As indicated in the modified 103 rejection above, Koka and Kaufman teach the indicated limitations of the claim.
The applicant’s arguments, regarding the dependent claims, rely on the arguments related to the independent claims, and as such are also deemed as not persuasive.
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 ARI SINGH KANE PADDA whose telephone number is (571)272-7228. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ARI SINGH KANE PADDA/ Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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