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
The Applicant filed Amendments to the Claims and Remarks on April 7, 2026 in response to the Examiner’s Non-Final Office Action, mailed January 16, 2026.
Amendments to the Claims
At this time, claims 1-7, 9-11, 13, 15-17, 19-21, 23-24, 36, and 57 are pending. Claims 9, 25, and 32 have been amended. Claim 8 has been cancelled. The Applicant has added new claim 57. Claims 1 and 25 are in independent form. (Remarks, pg. 9)
Claim Rejections - 35 U.S.C. § 103
Claims 1-3, 5-11, 13, 15-17, 19-21, 23-27, 29-34, and 36 were previously rejected under 35 U.S.C. 103. (Remarks, pg. 9-11)
Regarding independent claim 1, the Applicant has specifically argued that Weiss (previously cited), either alone or in combination with primary art reference Litvak, fails to disclose or suggest (i) “a conversion of electrophysiological traces from a time domain to a frequency domain” (emphasis added by Applicant); (ii) “converting the plurality of electrophysiological traces from a time domain to a frequency domain to obtain a number of electrophysiological frequency component sets”, as recited by independent claim 1. (Remarks, pg. 9-10)
The Examiner has found the arguments pertaining to independent claim 1 to be persuasive.
Regarding amended, independent claim 25 and new, dependent claim 57, the Applicant has argued that Weiss (previously cited), either alone or in combination with primary art reference Litvak, fails to disclose or suggest “determining a coherence or a concentration of the angles”. (Remarks, pg. 10)
The Examiner respectfully disagrees. Weiss discloses determining a coherence or concentration oh the angles in paras. [0115]-[0117] in discussing the distribution of angles and determining their uniformity (i.e. coherence). The Examiner’s arguments have been amended in this office action.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Regarding amended, dependent claims 9 and 32, the Applicant has argued that Weiss (previously cited), either alone or in combination with primary art reference Litvak, fails to disclose or suggest to "determine whether the clustering of the phase angles is greater than a clustering threshold, wherein the clustering threshold is determined based on a predetermined coherence or a predetermined concentration of a set of phase angles”, as recited by dependent claim 32 and similarly in dependent claim 9. (Remarks, pg. 10-11)
The Examiner once again respectfully disagrees. Similar to the Examiner’s arguments above (regarding claims 25 and 57), the Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Therefore, the previous claim rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made in view of a different interpretation of the previously applied references and with the newly-applied reference of Malchano (previously cited as pertinent prior art).
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 1-3, 5- 7, 9-11, 13, 15-17, 19-21, 23-24, and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Litvak et al. (US 2015/0051654, hereinafter referred to as Litvak) and Weiss et al. (US 2019/0307345, hereinafter referred to as Weiss), further in view of Malchano et al. (US 2018/0133507, hereinafter referred to as Malchano).
Regarding independent claim 1, Litvak discloses programming systems for eliciting evoked responses in a cochlear implant patient and performing predetermined actions in accordance with the evoked responses. Litvak further discloses a method, comprising:
delivering stimulation signal sets to tissue of a recipient ([0041]: “For example, evoked response management facility 302 may direct cochlear implant system 104 to apply electrical stimulation to the patient by way of at least one electrode 116 included in electrode array 114 (i.e., by transmitting one or more commands to sound processor 108 by way of programming interface device 122 for sound processor 108 to direct cochlear implant 112 to apply the electrical stimulation).”);
recording, via an electrode configured to be implanted in the recipient ([0044]: “…evoked response management facility 302 may use one or more electrodes to monitor for and record the evoked response.”), an electrophysiological trace from the tissue in response to each of a plurality of the stimulation signal sets to obtain a plurality of electrophysiological traces;
[obtaining] a number of electrophysiological frequency component sets, wherein each electrophysiological frequency component set corresponds to one of the plurality of electrophysiological traces ([0069]: “Programming device 120 may additionally or alternatively use the evoked response to determine one or more optimal crossover frequencies associated with the patient. As used herein, a “crossover frequency” refers to a boundary frequency that separates frequencies represented to the patient by acoustic stimulation and frequencies represented to the patient by electrical stimulation. …Programming device 120 may then determine a crossover frequency to be used by the EAS system by determining that acoustic stimulation evokes robust hair cell and neural responses until 450 Hz and designating this frequency as the crossover frequency (i.e., the apical-most electrode can start providing electrical stimulation around that frequency).”); and
determining whether the plurality of electrophysiological traces represent a biological response ([0059]: “…programming device 120 may record an evoked response that occurs in response to electrical and/or acoustic stimulation and compare the evoked response to a baseline response and/or one or more previously recorded evoked responses. As used herein, a “baseline response” refers to some type of fixed evoked response that a clinician may consider to be normal, acceptable, and/or desirable. To illustrate, FIG. 6 shows an exemplary baseline response 602 and two possible evoked responses 604-1 and 604-2 that may occur in response to stimulation provided by cochlear implant system 104 and/or receiver 124.”).
Litvak is silent to:
converting the plurality of electrophysiological traces from a time domain to a frequency domain; and
determining phase angles of one or more frequency components from each of a plurality of the electrophysiological frequency component sets.
However, Weiss teaches a signal processing method for distinguishing and characterizing high-frequency oscillations. Weiss further teaches:
determining phase angles of one or more frequency components from each of a plurality of the electrophysiological frequency component sets ([0116]: “We developed a method to determine whether all the ripple phasors of a given type recorded from a single macroelectrode contact exhibited unimodal or bimodal clustering around preferred, i.e., mean phase angle(s).”).
Weiss is considered analogous art to that of Litvak and the instant application, as the reference teaches signal processing specially adapted for physiological signals or for diagnostic purposes. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include phase angle analysis of electrophysiological frequency component sets in order to observe the effects of a stimulation on a patient and ensure that the target biological response is met via therapy.
The Litvak/Weiss combination is silent to converting the plurality of electrophysiological traces from a time domain to a frequency domain.
However, Malchano teaches methods and systems for neural stimulation via visual, auditory and peripheral nerve stimulations. Malchano further teaches converting the plurality of electrophysiological traces from a time domain to a frequency domain ([0793]: “At block 3345, the [cognitive assessment system or “CAS”] can determine whether a maximum frequency of the neural response is approximately equal to the specified frequency. The CAS can sample the neural response received from the measurement devices and convert the neural response from a time domain signal to a frequency domain signal.”; Fig. 33).
Malchano is of a similar pursuit to that of the instant application in teaching acoustic or auditory stimuli and measuring electrophysiological signals using evoked responses. Thus, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Litvak/Weiss combination to properly obtain a number of electrophysiological frequency component sets.
Regarding claim 2, in view of the Litvak/Weiss/Malchano combination, Litvak discloses that delivering each of the stimulation signal sets to the tissue of the recipient ([0041]), comprises:
delivering one or more electrical stimulation signals to the tissue of the recipient via one or more electrodes configured to be implanted in the recipient ([0030]: “Cochlear implant 112 may be further configured to apply the electrical stimulation to one or more stimulation sites within the patient via one or more electrodes 116 disposed along electrode array 114.”).
Regarding claim 3, in view of the Litvak/Weiss/Malchano combination, Litvak discloses delivering each of the stimulation signal sets to the tissue of the recipient ([0041]), comprises:
delivering one or more acoustical stimulation signals to the tissue of the recipient ([0038]: “…receiver 124 may be configured to apply acoustic stimulation to the patient as directed by programming device 120.”; [0042]; [0044]: “Evoked response management facility 302 may determine whether an evoked response occurs in response to the stimulation (i.e., the electrical and/or acoustic stimulation) in any suitable manner.”).
Regarding claim 5, in view of the Litvak/Weiss/Malchano combination, Litvak discloses that recording an electrophysiological trace from the tissue in response to a stimulation signal set ([0044]: “…evoked response management facility 302 may use one or more electrodes to monitor for and record the evoked response.”) comprises:
recording a plurality of neuron action potentials for a period of time following delivery of the stimulation signal set to the tissue of the recipient ([0081]: “In some examples, programming device 120 may perform one or more predetermined actions in accordance with a plurality of evoked responses recorded over a period of time.”).
Regarding claim 6, in view of the Litvak/Weiss/Malchano combination, Litvak is silent to that converting the plurality of electrophysiological traces from the time domain to the frequency domain comprises:
extracting phase and frequency components from each of the plurality of electrophysiological traces.
However, Weiss teaches that converting the plurality of electrophysiological traces from the time domain to the frequency domain (Figs. 1 and 3-4 show time-frequency plots of electrophysiological signals.) comprises:
extracting phase and frequency components from each of the plurality of electrophysiological traces ([0071]: “A time-frequency analysis of the iEEG recording was performed using a wavelet convolution in the time domain. Complex Morlet wavelets were created with constant frequency domain width…”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention of Litvak to include extracting phase and frequency components from each of the plurality of electrophysiological traces in order to more effectively analyze the effects of the stimulation signal on a patient.
Regarding claim 7, in view of the Litvak/Weiss/Malchano combination, Litvak discloses a fundamental frequency of the target biological response ([0059]: “…programming device 120 may record an evoked response that occurs in response to electrical and/or acoustic stimulation and compare the evoked response to a baseline response and/or one or more previously recorded evoked responses. As used herein, a “baseline response” refers to some type of fixed evoked response that a clinician may consider to be normal, acceptable, and/or desirable. To illustrate, FIG. 6 shows an exemplary baseline response 602 and two possible evoked responses 604-1 and 604-2 that may occur in response to stimulation provided by cochlear implant system 104 and/or receiver 124.”).
Litvak is silent to that determining phase angles of one or more frequency components from each of the plurality of electrophysiological frequency component sets comprises:
determining phase angles of a frequency component.
However, Weiss teaches that determining phase angles of one or more frequency components from each of the plurality of electrophysiological frequency component sets ([0116]: “We developed a method to determine whether all the ripple phasors of a given type recorded from a single macroelectrode contact exhibited unimodal or bimodal clustering around preferred, i.e., mean phase angle(s).”) comprises:
determining phase angles of a frequency ([0116]: “We developed a method to determine whether all the ripple phasors of a given type recorded from a single macroelectrode contact exhibited unimodal or bimodal clustering around preferred, i.e., mean phase angle(s).”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include phase angle analysis of electrophysiological frequency component sets in order to observe the effects of a stimulation on a patient and ensure that the target biological response is met via therapy.
Regarding amended claim 9, in view of the Litvak/Weiss/Malchano combination, Litvak discloses that determining whether the plurality of electrophysiological traces represent the target biological response ([0059]: “…programming device 120 may record an evoked response that occurs in response to electrical and/or acoustic stimulation and compare the evoked response to a baseline response and/or one or more previously recorded evoked responses. As used herein, a “baseline response” refers to some type of fixed evoked response that a clinician may consider to be normal, acceptable, and/or desirable. To illustrate, FIG. 6 shows an exemplary baseline response 602 and two possible evoked responses 604-1 and 604-2 that may occur in response to stimulation provided by cochlear implant system 104 and/or receiver 124.”).
Litvak is silent to clustering the phase angles of the one or more frequency components from each of the plurality of the electrophysiological frequency component sets; and
determining whether the clustering of the phase angles is greater than a clustering threshold, wherein the clustering threshold is determined based on a predetermined coherence or a predetermined concentration of a set of phase angles.
However, Weiss teaches clustering the phase angles of the one or more frequency components from each of the plurality of the electrophysiological frequency component sets ([0115]-[0117]); and
determining whether the clustering of the phase angles is greater than a clustering threshold ([0116]: “…to determine whether all the ripple phasors of a given type recorded from a single macroelectrode contact exhibited unimodal or bimodal clustering around preferred, i.e., mean phase angle(s). …If this test met significance (p<0.05) the population of phase angles was categorized as bimodal and the mean phase angles of each of the two clusters was recorded. If the Kuiper two-sample test did not meet significance, or the agglomerative method resulted in clusters with less than 15 angles, we combined the clusters and tested for unimodal clustering around a mean phase angle using the Rayleigh test for non-uniformity of circular data (circ_rtest.m). If this test met significance (p<0.05) the single mean phase angle defined using (circ_mean.m) was recorded, otherwise the distribution of angles was assumed to be uniform.”), wherein the clustering threshold is determined based on a predetermined coherence or a predetermined concentration of a set of phase angles ([0116]: “…preferred, i.e., mean phase angle(s)…”; [0117]: “For a single macroelectrode contact, we used the mean and standard deviation of the preferred phase angle of the ‘peak-trough transition’ category derived from each neuroanatomic region to distinguish the two clusters of phasors. If its preferred phase angle was distributed within the mean and standard deviation of the preferred phase angle, each ripple phasor was categorized as a ripple event occurring during the peak-trough transition. Otherwise, other ripple phasors were categorized as ripple events occurring during the trough-peak transition.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include cluster analysis of phase angles and determining if a clustering threshold is met in order to determine if an evoked response is present following the delivery of a stimulation signal.
Regarding claim 10, in view of the Litvak/Weiss/Malchano combination, Litvak is silent to determining whether a mean phase angle of the phase angles of the one or more frequency components from each of the plurality of electrophysiological frequency component sets is within an expected phase angle region that is correlated with phase angles which produce plausible morphologies associated with the target biological response.
However, Weiss teaches determining whether a mean phase angle of the phase angles of the one or more frequency components from each of the plurality of electrophysiological frequency component sets is within an expected phase angle region that is correlated with phase angles which produce plausible morphologies associated with the target biological response ([0117]: “When the two clusters of mean phase angles were statistically distinct, each phase angle was labeled as the following based on their approximate diametrical alignment: the transition from the depth peak to trough (i.e., peak-trough transition) and the transition from the depth trough to peak (i.e., trough-peak transition). If the two clusters of mean phase angles were diametrically opposed between 0° and 180°, then the cluster with the mean phase angle distributed between 0° and 180° was by convention defined as the ‘peak-trough transition’. If the two distributions were diametrically opposed between 90° and 270°, then the cluster with the mean phase angle distributed between 90° and 270° was defined as the ‘peak-trough transition’.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include cluster analysis of phase angles and determining if a clustering threshold is met in order to determine if an evoked response is present following the delivery of a stimulation signal.
Regarding claim 11, in view of the Litvak/Weiss/Malchano combination, Litvak discloses that determining whether the plurality of electrophysiological traces represent the target biological response ([0059]: “…programming device 120 may record an evoked response that occurs in response to electrical and/or acoustic stimulation and compare the evoked response to a baseline response and/or one or more previously recorded evoked responses. As used herein, a “baseline response” refers to some type of fixed evoked response that a clinician may consider to be normal, acceptable, and/or desirable. To illustrate, FIG. 6 shows an exemplary baseline response 602 and two possible evoked responses 604-1 and 604-2 that may occur in response to stimulation provided by cochlear implant system 104 and/or receiver 124.”) comprises:
a closed-loop control function ([0077]: “…programming device 120 may automatically determine the source of the evoked responses… Programming device 120 may then take any appropriate action based on this determination (e.g., …adjust one or more control parameters associated with cochlear implant system 104…).”).
Litvak is silent to clustering the phase angles of the one or more frequency components from each of the plurality of electrophysiological frequency component sets; and
using the clustering of the phase angles in a closed-loop control function.
However, Weiss teaches clustering the phase angles of the one or more frequency components from each of the plurality of electrophysiological frequency component sets ([0115]-[0117]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include cluster analysis of phase angles and determining if a clustering threshold is met in order to determine if an evoked response is present following the delivery of a stimulation signal.
Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Litvak/Weiss combination to include utilizing the output clustering of the phase angles, as taught by Weiss, as a control parameter in Litvak’s closed-loop control function in order to provide safe and adaptive therapy to a patient.
Regarding claim 13, in view of the Litvak/Weiss/Malchano combination, Litvak discloses that using the clustering of the phase angles in a closed-loop control function ([0077]) comprises:
an implantable medical device (cochlear implant system 104 in Figs. 1, 4-5).
Litvak is silent to using the clustering of the phase angles to control at least one of a current level of an implantable medical device (cochlear implant system 104 in Figs. 1, 4-5) or sampling performed by an implantable medical device (cochlear implant system 104 in Figs. 1, 4-5).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention, however, to modify the Litvak/Weiss combination to include utilizing the output clustering of the phase angles, as taught by Weiss, as a control parameter in Litvak’s closed-loop control function in order to provide safe and adaptive therapy to a patient via controlling at least one of a current level sampling.
Regarding claim 15, in view of the Litvak/Weiss/Malchano combination, Litvak discloses that determining, based on the phase angles of the one or more frequency components from each of the plurality of electrophysiological frequency component sets, whether the plurality of electrophysiological traces represent the target biological response ([0059]: “…programming device 120 may record an evoked response that occurs in response to electrical and/or acoustic stimulation and compare the evoked response to a baseline response and/or one or more previously recorded evoked responses. As used herein, a “baseline response” refers to some type of fixed evoked response that a clinician may consider to be normal, acceptable, and/or desirable. To illustrate, FIG. 6 shows an exemplary baseline response 602 and two possible evoked responses 604-1 and 604-2 that may occur in response to stimulation provided by cochlear implant system 104 and/or receiver 124.”) comprises:
determining, based on the phase angles of the one or more frequency components from each of the plurality of electrophysiological frequency component sets, whether the plurality of electrophysiological traces represent an electrically evoked compound action potential (ECAP) response ([0044]: “Evoked response management facility 302 may determine whether an evoked response occurs in response to the stimulation (i.e., the electrical and/or acoustic stimulation) in any suitable manner. For example, evoked response management facility 302 may use one or more electrodes to monitor for and record the evoked response. Likewise, a neural response (e.g., an auditory nerve response and/or a compound action potential) may be recorded using one or more electrodes positioned within or near the cochlea.”).
Regarding claim 16, in view of the Litvak/Weiss/Malchano combination, Litvak discloses that determining, based on the phase angles of the one or more frequency components from each of the plurality of electrophysiological frequency component sets, whether the plurality of electrophysiological traces represent the target biological response ([0059]: “…programming device 120 may record an evoked response that occurs in response to electrical and/or acoustic stimulation and compare the evoked response to a baseline response and/or one or more previously recorded evoked responses. As used herein, a “baseline response” refers to some type of fixed evoked response that a clinician may consider to be normal, acceptable, and/or desirable. To illustrate, FIG. 6 shows an exemplary baseline response 602 and two possible evoked responses 604-1 and 604-2 that may occur in response to stimulation provided by cochlear implant system 104 and/or receiver 124.”) comprises:
determining, based on the phase angles of the one or more frequency components from each of the plurality of electrophysiological frequency component sets, whether the plurality of electrophysiological traces represent an electrocochleography (ECoG) response ([0044]: “Evoked response management facility 302 may determine whether an evoked response occurs in response to the stimulation (i.e., the electrical and/or acoustic stimulation) in any suitable manner. For example, evoked response management facility 302 may use one or more electrodes to monitor for and record the evoked response. For example, a cochlear response (e.g., cochlear microphonics) may be recorded using one or more electrodes positioned within the cochlea (e.g., one or more of electrodes 116), one or more electrodes positioned within the round window, and/or one or more electrodes positioned at any other suitable location relatively near the cochlea.”).
Regarding claim 17, in view of the Litvak/Weiss/Malchano combination, Litvak discloses generating one or more outputs ([0093]: “I/O module 908 may include one or more devices for presenting output to a user, including, but not limited to, a graphics engine, a display (e.g., a display screen, one or more output drivers (e.g., display drivers), one or more audio speakers, and one or more audio drivers. In certain embodiments, I/O module 908 is configured to provide graphical data to a display for presentation to a user. The graphical data may be representative of one or more graphical user interfaces and/or any other graphical content as may serve a particular implementation.”; Fig. 9) representative of the determination of whether the plurality of electrophysiological traces represent the target biological response ([0059]: “…programming device 120 may record an evoked response that occurs in response to electrical and/or acoustic stimulation and compare the evoked response to a baseline response and/or one or more previously recorded evoked responses. As used herein, a “baseline response” refers to some type of fixed evoked response that a clinician may consider to be normal, acceptable, and/or desirable. To illustrate, FIG. 6 shows an exemplary baseline response 602 and two possible evoked responses 604-1 and 604-2 that may occur in response to stimulation provided by cochlear implant system 104 and/or receiver 124.”).
Regarding claim 19, in view of the Litvak/Weiss/Malchano combination, Litvak discloses generating one or more outputs indicating a parameter ([0093]) associated with the phase angles of the one or more frequency components from each of the plurality of electrophysiological frequency component sets.
While the Litvak/Weiss/Malchano combination does not specifically generating one or more outputs indicating a parameter associated with the phase angles, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention that the modified Litvak/Weiss combination would be able to output such data for analysis and determination of steps within the closed loop functionality.
Regarding claim 20, in view of the Litvak/Weiss/Malchano, Litvak is silent to that the parameter associated with the phase angles of the one or more frequency components comprises a concentration associated with a clustering of the phase angles of the one or more frequency components from each of the plurality of electrophysiological frequency component sets.
However, Weiss teaches that that the parameter associated with the phase angles of the one or more frequency components comprises a concentration associated with a clustering of the phase angles of the one or more frequency components from each of the plurality of electrophysiological frequency component sets ([0117]: “For a single macroelectrode contact, we used the mean and standard deviation of the preferred phase angle of the ‘peak-trough transition’ category derived from each neuroanatomic region to distinguish the two clusters of phasors.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include cluster analysis of phase angles and determining a clustering concentration in order to further analyze biological signals of a patient and output data.
Regarding claim 21, in view of the Litvak/Weiss/Malchano combination, Litvak discloses implementing a closed-loop control ([0077]: “…programming device 120 may automatically determine the source of the evoked responses… Programming device 120 may then take any appropriate action based on this determination (e.g., …adjust one or more control parameters associated with cochlear implant system 104…).”) at an implantable medical device (cochlear implant system 104 in Figs. 1, 4-5) implantable in the recipient.
Litvak is silent to using the parameter associated with the phase angles of the one or more frequency components from each of the plurality of electrophysiological frequency component sets.
However, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Litvak/Weiss combination to include utilizing the output of the phase angles, as taught by Weiss, as a control parameter in Litvak’s closed-loop control function in order to provide safe and adaptive therapy to a patient.
Regarding claim 23, in view of the Litvak/Weiss/Malchano combination, Litvak discloses determining whether the plurality of electrophysiological traces represent a target biological response ([0059]: “…programming device 120 may record an evoked response that occurs in response to electrical and/or acoustic stimulation and compare the evoked response to a baseline response and/or one or more previously recorded evoked responses. As used herein, a “baseline response” refers to some type of fixed evoked response that a clinician may consider to be normal, acceptable, and/or desirable. To illustrate, FIG. 6 shows an exemplary baseline response 602 and two possible evoked responses 604-1 and 604-2 that may occur in response to stimulation provided by cochlear implant system 104 and/or receiver 124.”).
Litvak is silent to determining that a frequency component of at least one of the plurality of electrophysiological frequency component sets is an out-of-family frequency component; and
excluding the out-of-family frequency component of at least one of the plurality of electrophysiological frequency component sets from use.
However, Weiss teaches determining that a frequency component of at least one of the plurality of electrophysiological frequency component sets is an out-of-family frequency component ([0116]: “A criterion for bimodal coupling (i.e., two distinct clusters) was that both clusters had at least 15 members (i.e., angles). We introduced this criterion to increase the probability that the clusters defined by the agglomerative method reflected distinct populations as opposed to outliers.”); and
excluding the out-of-family frequency component of at least one of the plurality of electrophysiological frequency component sets from use ([0116]: “A criterion for bimodal coupling (i.e., two distinct clusters) was that both clusters had at least 15 members (i.e., angles). We introduced this criterion to increase the probability that the clusters defined by the agglomerative method reflected distinct populations as opposed to outliers.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include identifying and excluding the out-of-family frequency component of at least one of the plurality of electrophysiological frequency component sets from use in order to remove such outliers from being used by the system’s closed loop decision algorithm, as they could lead to the patient receiving inadequate or even harmful therapy from the stimulation signal.
Regarding claim 24, in view of the Litvak/Weiss/Malchano combination, Litvak is silent to determining that the frequency component of at least one of the plurality of electrophysiological frequency component sets is an out-of-family frequency component based on an incidence of sound associated with the frequency component.
However, Weiss teaches determining that the frequency component of at least one of the plurality of electrophysiological frequency component sets is an out-of-family frequency component based on an incidence of sound associated with the frequency component ([0116]: “A criterion for bimodal coupling (i.e., two distinct clusters) was that both clusters had at least 15 members (i.e., angles). We introduced this criterion to increase the probability that the clusters defined by the agglomerative method reflected distinct populations as opposed to outliers.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include identifying and excluding the out-of-family frequency component of at least one of the plurality of electrophysiological frequency component sets from use in order to remove such outliers from being used by the system’s closed loop decision algorithm, as they could lead to the patient receiving inadequate or even harmful therapy from the stimulation signal.
Regarding new claim 57, in view of the Litvak/Weiss/Malchano combination, Litvak discloses that determining, based on the phase angles of the one or more frequency components from the plurality of electrophysiological frequency component sets, whether the plurality of electrophysiological traces represent the target biological response ([0059]: “…programming device 120 may record an evoked response that occurs in response to electrical and/or acoustic stimulation and compare the evoked response to a baseline response and/or one or more previously recorded evoked responses. As used herein, a “baseline response” refers to some type of fixed evoked response that a clinician may consider to be normal, acceptable, and/or desirable. To illustrate, FIG. 6 shows an exemplary baseline response 602 and two possible evoked responses 604-1 and 604-2 that may occur in response to stimulation provided by cochlear implant system 104 and/or receiver 124.”).
Litvak is silent to determining, based on a coherence or a concentration of the phase angles, whether the plurality of electrophysiological traces represent the target biological response
However, Weiss in combination with Litvak teaches determining, based on a coherence or a concentration of the phase angles, whether the plurality of electrophysiological traces represent the target biological response ([0116]: “…preferred, i.e., mean phase angle(s)…”; [0117]: “For a single macroelectrode contact, we used the mean and standard deviation of the preferred phase angle of the ‘peak-trough transition’ category derived from each neuroanatomic region to distinguish the two clusters of phasors. If its preferred phase angle was distributed within the mean and standard deviation of the preferred phase angle, each ripple phasor was categorized as a ripple event occurring during the peak-trough transition. Otherwise, other ripple phasors were categorized as ripple events occurring during the trough-peak transition.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include phase angle analysis of electrophysiological frequency component sets in order to observe the effects of a stimulation on a patient and ensure that the target biological response is met via therapy.
Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include cluster analysis of phase angles and determining if a clustering threshold is met in order to determine if an evoked response is present following the delivery of a stimulation signal.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over the Litvak/Weiss/Malchano combination, further in view of Bernhard et al. (WO 2011/098144, hereinafter referred to as Bernhard).
Regarding claim 4, in view of the Litvak/Weiss/Malchano combination, Litvak discloses delivering each of the stimulation signal sets to the tissue of the recipient ([0041]).
The Litvak/Weiss/Malchano combination is silent to delivering one or more mechanical stimulation signals to the recipient.
However, Bernhard teaches a hearing aid comprising an intra-cochlear actuator. Bernhard further teaches delivering one or more mechanical stimulation signals to the recipient (actuator 20 in Figs. 1-3, 7; [pg. 8, li. 1-4]).
Bernhard teaches a similar pursuit to that of Litvak and the instant application in teaching cochlear stimulation and cochlear electrodes. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include a mechanical actuator as taught by Bernhard in order to deliver mechanical stimulation signals to a recipient.
Claims 25-27, 29-34, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over the Litvak, further in view of Weiss.
Regarding amended, independent claim 25, in view of the Litvak/Weiss combination, Litvak discloses a system (configuration 100 in Fig. 1; [0021]: “…configuration 100 in which a programming system 102 is communicatively coupled to a cochlear implant system 104.”), comprising:
at least one electrode configured to be implanted in a recipient (plurality of electrodes 116 in Fig. 1; [0022]: “…cochlear implant system 104 may include …an electrode array 114 with a plurality of electrodes 116 disposed thereon.”);
a recording module (programming device 120 in Fig. 1 comprising of evoked response management facility 302 in Fig. 3) configured to record a plurality of sets of evoked electrophysiological signals from tissue of the recipient via the at least one electrode ([0044]: “…evoked response management facility 302 may use one or more electrodes to monitor for and record the evoked response.”); and
one or more processors (programming device 120 in Figs. 1, 3 comprising processing facility 304 in Fig. 3; [0048]: “Processing facility 304 may be configured to perform one or more processing operations. For example, processing facility 304 may perform one or more programming and/or fitting operations associated with cochlear implant system 104.”) configured to:
generate a number of frequency component sets from the plurality of sets of evoked electrophysiological signals ([0069]: “Programming device 120 may additionally or alternatively use the evoked response to determine one or more optimal crossover frequencies associated with the patient. …Programming device 120 may then determine a crossover frequency to be used by the EAS system by determining that acoustic stimulation evokes robust hair cell and neural responses until 450 Hz and designating this frequency as the crossover frequency (i.e., the apical-most electrode can start providing electrical stimulation around that frequency).”).
Litvak is silent to:
determine phase angles of one or more frequency components from each of a plurality of the frequency component sets, and
cluster the phase angles to determine, based on a coherence or a concentration of the phase angles, whether the plurality of sets of evoked electrophysiological signals are associated with a predetermined evoked biological response.
However, Weiss teaches to determine phase angles of one or more frequency components from each of a plurality of the frequency component sets ([0116]: “We developed a method to determine whether all the ripple phasors of a given type recorded from a single macroelectrode contact exhibited unimodal or bimodal clustering around preferred, i.e., mean phase angle(s).”), and
cluster the phase angles to determine, based on a coherence or a concentration of the phase angles ([0116]: “…preferred, i.e., mean phase angle(s)…”; [0117]: “For a single macroelectrode contact, we used the mean and standard deviation of the preferred phase angle of the ‘peak-trough transition’ category derived from each neuroanatomic region to distinguish the two clusters of phasors. If its preferred phase angle was distributed within the mean and standard deviation of the preferred phase angle, each ripple phasor was categorized as a ripple event occurring during the peak-trough transition. Otherwise, other ripple phasors were categorized as ripple events occurring during the trough-peak transition.”), whether the plurality of sets of evoked electrophysiological signals are associated with a predetermined evoked biological response ([0115]-[0117]).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include phase angle analysis of electrophysiological frequency component sets in order to observe the effects of a stimulation on a patient and ensure that the target biological response is met via therapy.
Further, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include cluster analysis of phase angles and determining if a clustering threshold is met in order to determine if an evoked response is present following the delivery of a stimulation signal.
Regarding claim 26, in view of the Litvak/Weiss combination, Litvak discloses a stimulator unit (cochlear implant 112 in Figs. 1, 4-5) configured to deliver one or more electrical stimulation signals to the tissue of the recipient to evoke the electrophysiological signals ([0030]: “Cochlear implant 112 may be further configured to apply the electrical stimulation to one or more stimulation sites within the patient via one or more electrodes 116 disposed along electrode array 114.”; [0041]).
Regarding claim 27, in view of the Litvak/Weiss combination, Litvak discloses a receiver (receiver 124 in Fig. 1) configured to deliver one or more acoustical stimulation signals to the tissue of the recipient to evoke the electrophysiological signals ([0038]: “…receiver 124 may be configured to apply acoustic stimulation to the patient as directed by programming device 120.”; [0042]; [0044]: “Evoked response management facility 302 may determine whether an evoked response occurs in response to the stimulation (i.e., the electrical and/or acoustic stimulation) in any suitable manner.”).
Regarding claim 29, in view of the Litvak/Weiss combination, Litvak discloses that to record each of the plurality of sets of evoked electrophysiological signals, the recording module (programming device 120 in Fig. 1 comprising of evoked response management facility 302 in Fig. 3; [0044]: “…evoked response management facility 302 may use one or more electrodes to monitor for and record the evoked response.”) is configured to record a plurality of neuron action potentials for a period of time following delivery of a stimulation signal set to the tissue of the recipient ([0081]: “In some examples, programming device 120 may perform one or more predetermined actions in accordance with a plurality of evoked responses recorded over a period of time.”).
Regarding claim 30, in view of the Litvak/Weiss combination, Litvak discloses that to generate the frequency component sets from the plurality of sets of evoked electrophysiological signals, the one or more processors (programming device 120 in Figs. 1, 3 comprising processing facility 304 in Fig. 3) are configured to:
extract phase and frequency components from each of the plurality of sets of evoked electrophysiological signals ([0048]: “Processing facility 304 may be configured to perform one or more processing operations. For example, processing facility 304 may perform one or more programming and/or fitting operations associated with cochlear implant system 104.”).
Regarding claim 31, in view of the Litvak/Weiss combination, Litvak is silent to determining phase angles of a frequency component associated with a fundamental frequency of the predetermined evoked biological response.
However, Weiss teaches that determining phase angles of a frequency component associated with a fundamental frequency of the predetermined evoked biological response ([0116]: “We developed a method to determine whether all the ripple phasors of a given type recorded from a single macroelectrode contact exhibited unimodal or bimodal clustering around preferred, i.e., mean phase angle(s).”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include phase angle analysis of electrophysiological frequency component sets in order to observe the effects of a stimulation on a patient and ensure that the target biological response is met via therapy.
Regarding amended claim 32, in view of the Litvak/Weiss combination, Litvak is silent to determining whether the clustering of the phase angles is greater than a clustering threshold, wherein the clustering threshold is determined based on a predetermined coherence or a predetermined concentration of a set of phase angles.
However, Weiss teaches determining whether the clustering of the phase angles is greater than a clustering threshold ([0116]: “…to determine whether all the ripple phasors of a given type recorded from a single macroelectrode contact exhibited unimodal or bimodal clustering around preferred, i.e., mean phase angle(s). …If this test met significance (p<0.05) the population of phase angles was categorized as bimodal and the mean phase angles of each of the two clusters was recorded. If the Kuiper two-sample test did not meet significance, or the agglomerative method resulted in clusters with less than 15 angles, we combined the clusters and tested for unimodal clustering around a mean phase angle using the Rayleigh test for non-uniformity of circular data (circ_rtest.m). If this test met significance (p<0.05) the single mean phase angle defined using (circ_mean.m) was recorded, otherwise the distribution of angles was assumed to be uniform.”), wherein the clustering threshold is determined based on a predetermined coherence or a predetermined concentration of a set of phase angles ([0116]: “…preferred, i.e., mean phase angle(s)…”; [0117]: “For a single macroelectrode contact, we used the mean and standard deviation of the preferred phase angle of the ‘peak-trough transition’ category derived from each neuroanatomic region to distinguish the two clusters of phasors. If its preferred phase angle was distributed within the mean and standard deviation of the preferred phase angle, each ripple phasor was categorized as a ripple event occurring during the peak-trough transition. Otherwise, other ripple phasors were categorized as ripple events occurring during the trough-peak transition.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include cluster analysis of phase angles and determining if a clustering threshold is met in order to determine if an evoked response is present following the delivery of a stimulation signal.
Regarding claim 33, in view of the Litvak/Weiss combination, Litvak is silent to determining whether a mean phase angle of the phase angles of the one or more frequency components from each of the plurality of the frequency component sets is within an expected phase angle region that is correlated with phase angles which produce plausible morphologies associated with the predetermined evoked biological response.
However, Weiss teaches determining whether a mean phase angle of the phase angles of the one or more frequency components from each of the plurality of electrophysiological frequency component sets is within an expected phase angle region that is correlated with phase angles which produce plausible morphologies associated with the target biological response ([0117]: “When the two clusters of mean phase angles were statistically distinct, each phase angle was labeled as the following based on their approximate diametrical alignment: the transition from the depth peak to trough (i.e., peak-trough transition) and the transition from the depth trough to peak (i.e., trough-peak transition). If the two clusters of mean phase angles were diametrically opposed between 0° and 180°, then the cluster with the mean phase angle distributed between 0° and 180° was by convention defined as the ‘peak-trough transition’. If the two distributions were diametrically opposed between 90° and 270°, then the cluster with the mean phase angle distributed between 90° and 270° was defined as the ‘peak-trough transition’.”).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include cluster analysis of phase angles and determining if a clustering threshold is met in order to determine if an evoked response is present following the delivery of a stimulation signal.
Regarding claim 34, in view of the Litvak/Weiss combination, Litvak discloses a closed-loop control function ([0077]: “…programming device 120 may automatically determine the source of the evoked responses… Programming device 120 may then take any appropriate action based on this determination (e.g., …adjust one or more control parameters associated with cochlear implant system 104…).”).
Litvak is silent to using the clustering of the phase angles in a closed-loop control function.
However, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the Litvak/Weiss combination to include utilizing the output clustering of the phase angles, as taught by Weiss, as a control parameter in Litvak’s closed-loop control function in order to provide safe and adaptive therapy to a patient.
Regarding claim 36, in view of the Litvak/Weiss combination, Litvak is silent to using the clustering of the phase angles to control at least one of a current level of an implantable medical device (cochlear implant system 104 in Figs. 1, 4-5) or sampling performed by an implantable medical device (cochlear implant system 104 in Figs. 1, 4-5).
It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention, however, to modify the Litvak/Weiss combination to include utilizing the output clustering of the phase angles, as taught by Weiss, as a control parameter in Litvak’s closed-loop control function in order to provide safe and adaptive therapy to a patient via controlling at least one of a current level sampling.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over the Litvak/Weiss combination, further in view of Bernhard.
Regarding claim 28, in view of the Litvak/Weiss combination, the Litvak/Weiss combination is silent to an actuator configured to deliver one or more mechanical stimulation signals to the tissue of the recipient to evoke the electrophysiological signals.
However, Bernhard teaches a hearing aid comprising an intra-cochlear actuator. Bernhard further teaches an actuator configured to deliver one or more mechanical stimulation signals to the tissue of the recipient to evoke the electrophysiological signals. (actuator 20 in Figs. 1-3, 7; [pg. 8, li. 1-4]).
Bernhard teaches a similar pursuit to that of Litvak and the instant application in teaching cochlear stimulation and cochlear electrodes. It would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Litvak to include a mechanical actuator as taught by Bernhard in order to deliver mechanical stimulation signals to a recipient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Torres (US 2019/0261909).
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.
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/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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