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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/28/2025 is being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure . Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Page 8, para. 0039 reads "external magnet 152" should read "external magnet 150".
Page 28, para. 00110 reads "medica device" should read "medical device".
Appropriate correction is required.
The use of the term Bluetooth, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 11 and are objected to because of the following informalities:
Claim 11, line 2, reads “the one or more parameters includes” should read “the one or more parameters of the stimulation signals include”.
Claim 15, line 2, reads "cause the processor" should read "causes the processor". Appropriate correction is required.
Claim Interpretation
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
stimulus adaption and smoothing module in claim 26.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
In light of the specification, the “stimulus adaption and smoothing module” in claim 26 under the broadest reasonable interpretation can be an algorithm in conjunction with a processor per para. 0077 (stimulus adaption and smoothing module 368 is configured to adjust one or more operations performed in the sound processing path 350 so as to achieve the target stimulus resolution (i.e., adapt the stimulus resolution of the electrical stimulation that is delivered to the recipient))).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5, 7-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Independent claims 1, 15, and 26 recite a method, computer readable storage media, and a medical device. Thus, they are directed to statutory categories of invention.
Step 2A, prong 1:
Claims 1, 15, and 26 recite the following claim limitations:
receiving environmental signals (claim 1)
delivering stimulation signals using first operational settings (claim 1)
determining that the stimulation signals are to be delivered using second operational settings (claim 1)
incrementally adjusting one or more parameters of the stimulation signals to transition from the first operational settings to the second operational settings (claim 1)
receive input signals (claims 15&26)
determine to switch to a second set of operational settings (claim 15)
gradually transition from use of the first set of operational settings to use of the second set of operating settings (claim 15)
convert input signals to stimulation signals (claim 15)
These limitations under their broadest reasonable interpretation cover concepts that can be practically performed in the human mind. A human could receive environmental signals, deliver stimulation based on environmental signals, and determine to change the stimulation. Thus, the claims recite limitations which fall within the ‘mental processes’ and method of organizing human activity grouping of abstract ideas.
Step 2A, prong 2:
Claims 1, 15, and 26 recite the following additional elements:
sensory device (claim 1)
computer readable storage media (claim 15)
processor (claim 15)
medical device (claims 15&16)
input element (claim 26)
processing path (claim 26)
stimulus adaption and smoothing module (claim 26)
The recited “sensory device”, “input element”, “processing path”, and “medical device” amount to nothing more than insignificant extra solution activity for data gathering.
Claim 15’s recitation of a computer readable storage media, that when executed by a processor, implement a method, are merely reciting the storage medium at a high-level of generality, and the computer readable storage media merely instructs the processor to carry out the steps of the method. In other words, the computer components are being used as a tool to carry out the method (See MPEP 2106.05(f)).
The recitation of a “processor” fails to recite any additional element or combination of additional elements that apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. As recited the processor is a convention component that does not impost any meaningful structural limitations on the system used to implement the judicial exception. Similarly, the “stimulus adaption and smoothing module”, which according to the applicant’s specification is a processor in conjunction with an algorithm (see para. 0077), is a convention component that does not impost any meaningful structural limitations on the system used to implement the judicial exception. Therefore, the recitation of the claimed elements in the claims does not integrate the judicial exception into a practical application because the claims merely use the claimed elements as a tool to perform the abstract idea.
Thus, the abstract idea is not integrated into a practical application. The combination of these additional elements is no more than insignificant extra solution activity, and mere instructions to apply the exception using generic computer components (the processors and computer readable storage media). Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application. The claims are directed to an abstract idea.
Step 2B:
As discussed above with respect to Step 2A Prong 2, the additional elements of storing the instructions in a computer readable storage media in claim 15, amounts to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B and does not provide an inventive concept.
The recitation of a processor/stimulus adaption and smoothing module is not sufficient to amount to significantly more than the judicial exception because they are recited at a high level of generality, there is no meaningful limitation, such as a particular or unconventional structure that distinguishes the elements from well-known, routine, and/or conventional elements. Recitation of a processor as a tool to perform the abstract idea does not add significantly more than what is well-known, routine, and/or conventional in view of Alice Corp. Pty. Ltd. V. CLS Bank Int'l, 573 U.S. 208, 223, 110 USPQ2d 1976, 1983 (2014).
For these reasons, there is no inventive concept. The claim is not patent eligible. Even when viewed as a whole, nothing in the claim adds significantly more to the abstract idea.
Dependent claims:
Claims 2-5, 11, 16-17, 23, 28-29, 32 recite limitations that further define the stimulation parameters that are adjusted.
Claims 7-10 recite limitations that further define the operational settings as electrode configurations or audio processing settings.
Claims 12 and 33 recite limitations that further limit the abstract idea, by defining the environmental signals that are detected.
Claim 13 further limits the abstract idea by adding the limitation of a “schedule”, which merely determines when to transition from a first operational setting to a second operational setting.
Claims 21-22 and 31 recite limitations that further define the processor/stimulation adaption and smoothing module, by defining the operational settings as electrode configurations. As mentioned above, the processor/stimulation adaption and smoothing module are recited at a high level of generality and are merely being used in their intended manner to transition from first operational settings to second operational settings.
Claim 35 recites limitations that further define the “stimulus adaption and smoothing module”, by adjusting the operation of the device based on the battery. This further limits the abstract idea as a human could determine when to use a stimulation signal based on how much battery is left or if the battery is full.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 1 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The method recites no structure or elements and therefore requires a human to do the mental processes and step.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 10, 12-13, 26, and 33 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kulkarni et al. (US 20220008739 A1), hereinafter Kulkarni.
Regarding claim 1, Kulkarni teaches a method (para. 0016 (methods for gradually adjusting a control parameter associated with a cochlear implant system)) comprising:
receiving environmental signals (para. 0025 (microphone 102 may be configured to detect audio signals presented to the patient), 0052 (Processing facility 402 may take into account one or more other time-based and/or environmental-based factors)) at a sensory device (Fig. 1, element 100 – cochlear implant system);
delivering, based on the environmental signals, stimulation signals to a recipient of the sensory device (para. 0026 (sound processor 104 may be configured to direct cochlear implant 108 to generate and apply electrical stimulation representative of one or more audio signals to one or more stimulation sites associated with an auditory pathway of the patient)) using first operational settings (para. 0058 (M level (or any other control parameter), 0057 (detected amount of sound exposure is above a first threshold within the predetermined time period, processing facility 402 may increase the control parameter));
determining that the stimulation signals are to be delivered to the recipient using second operational settings that are different from the first operational settings (para. 0057 (detected amount of sound exposure is below a second threshold within the predetermined time period), 0058 (when the patient leaves the loud environment and enters a relatively quiet environment, processing facility 402 may decrease the M level associated with the patient)); and
incrementally adjusting one or more parameters of the stimulation signals to transition from the first operational settings to the second operational settings (para. 0054 (processing facility 402 may take into account an amount of sound exposure to the patient during a determined time period while gradually adjusting the M level (or any other control parameter) towards the target value)).
Regarding claim 2, Kulkarni teaches the method of claim 1, wherein incrementally adjusting the one or more parameters of the stimulation signals includes incrementally adjusting one or more of a threshold level, a comfort level, or a volume level associated with the stimulation signals (para. 0003 (an M level represents a stimulation current level required to achieve comfortable loudness to the patient), 0022 (a control parameter may be a threshold level (“T level”)… represents a minimum stimulation current level that produces a sensed perception of sound by the patient)).
Regarding claim 10, Kulkarni teaches the method of claim 1, wherein the first operational settings and the second operational settings are sound processing settings (para. 0054 (processing facility 402 may take into account an amount of sound exposure to the patient during a determined time period while gradually adjusting the M level (or any other control parameter) towards the target value)).
Regarding claim 12, Kulkarni teaches the method of claim 1, wherein determining that the stimulation signals are to be delivered to the recipient using second operational settings is based on a change in an environmental classification of the environmental signals (para. 0054 (processing facility 402 may additionally or alternatively take into account one or more other environmental-based factors while gradually adjusting the control parameter towards the target value), 0058 (if the patient enters and stays in an environment that has relatively loud sounds (e.g., a noisy restaurant), processing facility 402 may at least temporarily increase an M level associated with the patient… When the patient leaves the loud environment and enters a relatively quiet environment (e.g., the patient's home), processing facility 402 may decrease the M level associated with the patient)).
Regarding claim 13, Kulkarni teaches the method of claim 1, wherein determining that the stimulation signals are to be delivered to the recipient using second operational settings is based on a schedule associated with the recipient (Fig. 6, element 600 – look-up table, para. 0036 (adaption time course data 408 may include data representative of an adaption time course associated with a particular control parameter)).
Regarding claim 26, Kulkarni teaches a medical device (Fig. 1, element 100 – cochlear implant system) comprising:
one or more input elements (Fig. 3, element 102 – microphone) configured to receive input signals (para. 0030 (audio signal detected by microphone 102));
a processing path configured to convert the input signals into one or more output signals for delivery to a recipient of the medical device (para. 0030 (cochlear implant 108 may be configured to generate electrical stimulation representative of an audio signal processed by sound processor 104)) using a first set of operational settings (para. 0058 (M level (or any other control parameter), 0057 (detected amount of sound exposure is above a first threshold within the predetermined time period, processing facility 402 may increase the control parameter)); and
a stimulus adaption and smoothing module (Fig. 4, element 104 – sound processor) configured to gradually adjust, over a period of time, operation of the processing path from use of the first set of operational settings to use of a second set of operational settings (para. 0057 (detected amount of sound exposure is below a second threshold within the predetermined time period), 0058 (when the patient leaves the loud environment and enters a relatively quiet environment, processing facility 402 may decrease the M level associated with the patient)).
Regarding claim 33, Kulkarni teaches the medical device of claim 26, wherein the input signals comprise one or more environmental signals (para. 0025 (microphone 102 may be configured to detect audio signals presented to the patient), 0052 (processing facility 402 may take into account one or more other time-based and/or environmental-based factors)), and wherein the stimulus adaption and smoothing module is configured to gradually adjust operation of the processing path based on one or more attributes of the one or more environmental signals (para. 0057 (detected amount of sound exposure is below a second threshold within the predetermined time period), 0058 (when the patient leaves the loud environment and enters a relatively quiet environment, processing facility 402 may decrease the M level associated with the patient)).
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 3-5 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni (US 20220008739 A1) and in view of Smith (US 10743114 B2).
Regarding claim 3, Kulkarni teaches the method of claim 1, and incrementally adjusting the one or more parameters of the stimulation signals (para. 0054 (processing facility 402 may take into account an amount of sound exposure to the patient during a determined time period while gradually adjusting the M level (or any other control parameter) towards the target value)).
Kulkarni does not teach wherein incrementally adjusting the one or more parameters of the stimulation signals includes incrementally adjusting a stimulus resolution of the stimulation signals.
Smith teaches adjusting a stimulus resolution of the stimulation signals (col. 10, lines 60-66 (stimulus resolution adaption module 168 may determine the target stimulus resolution and make corresponding processing adjusts in response to a triggering event, such as the detection of a change in the listening environment)).
Kulkarni and Smith are considered to be analogous to the claimed invention because they are in the same field of cochlear implant systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni to incorporate the teachings of Smith listed above and provide the one or more parameters of the stimulation signals to include incrementally adjusting a stimulus resolution of the stimulation signals. Doing so allows the resolution of the stimulation signals to be adjusted based on the detected environment signals, allowing the sound processor to deliver the stimulation signals appropriately.
Regarding claims 4-5, Kulkarni (in view of Smith) teaches the method of claim 3. Kulkarni does not teach wherein incrementally adjusting the stimulus resolution of the stimulation signals includes incrementally adjusting a spatial resolution and a temporal resolution of the stimulation signals.
Smith teaches adjusting the stimulus resolution of the stimulation signals includes incrementally adjusting a spatial resolution (col. 7, lines 63-65 (spatial resolution (i.e., the spatial attributes of the electrical stimulation) can be increased, for example through use of focused stimulation)) and a temporal resolution of the stimulation signals (col. 6, lines 18-21 (temporal attributes refer to the temporal coding to the electrical stimulation, such as the pulse rate)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni to incorporate the teachings of Smith listed above and provide the adjustment of the spatial and temporal resolution. Doing so allows the stimulation signals to be adjusted by both spatial and temporal resolution, based on the environment signals detected, allowing the sound processor to deliver the stimulation signals appropriately.
Regarding claim 28, Kulkarni teaches the medical device of claim 26, wherein the stimulus adaption and smoothing module (Fig. 4, element 104 – sound processor) is configured to incrementally adjust operation of the processing path (para. 0057 (detected amount of sound exposure is below a second threshold within the predetermined time period), 0058 (when the patient leaves the loud environment and enters a relatively quiet environment, processing facility 402 may decrease the M level associated with the patient)).
Kulkarni does not teach wherein the stimulus adaption and smoothing module is configured to incrementally adjust operation of the processing path to incrementally change a stimulus resolution of the output signals.
Smith teaches adjusting a stimulus resolution of the output signals (col. 10, lines 60-66 (stimulus resolution adaption module 168 may determine the target stimulus resolution and make corresponding processing adjusts in response to a triggering event, such as the detection of a change in the listening environment)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni to incorporate the teachings of Smith listed above and provide the one or more parameters of the stimulation signals to include incrementally adjusting a stimulus resolution of the stimulation signals. Doing so allows the resolution of the output signals to be adjusted based on the detected environment signals, allowing the sound processor to deliver the output signals appropriately.
Regarding claim 29, Kulkarni (in view of Smith) teaches the medical device of claim 28 and the stimulus adaption and smoothing module (Fig. 4, element 104 – sound processor).
Kulkarni does not teach wherein the stimulus adaption and smoothing module is configured to incrementally adjust operation of the processing path to incrementally change at least one of a spatial resolution of the output signals or a temporal resolution of the output signals.
Smith teaches adjusting at least one of a spatial resolution of the output signals or a temporal resolution of the output signals col. 7, lines 63-65 (spatial resolution (i.e., the spatial attributes of the electrical stimulation) can be increased, for example through use of focused stimulation), (col. 6, lines 18-21 (temporal attributes refer to the temporal coding to the electrical stimulation, such as the pulse rate)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni to incorporate the teachings of Smith listed above and provide the adjustment of the spatial and temporal resolution. Doing so allows the output signals to be adjusted by both spatial and temporal resolution, based on the environment signals detected, allowing the sound processor to deliver the output signals appropriately.
Claims 7-8 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni (US 20220008739 A1) and in view of Litvak et al. (US 20130197606 A1), hereinafter Litvak ’13.
Regarding claim 7, Kulkarni teaches the method of claim 1, and the first operational settings (para. 0058 (M level (or any other control parameter), 0057 (detected amount of sound exposure is above a first threshold within the predetermined time period, processing facility 402 may increase the control parameter)) and the second operation settings (para. 0057 (detected amount of sound exposure is below a second threshold within the predetermined time period), 0058 (when the patient leaves the loud environment and enters a relatively quiet environment, processing facility 402 may decrease the M level associated with the patient)).
Kulkarni does not teach wherein the first operational settings are associated with a first electrode configuration and the second operational settings are associated with a second electrode configuration.
Litvak ’13 teaches first operational settings are associated with a first electrode configuration (para. 0041 (stimulation parameters may be dynamically adjusted in accordance with the determined tonality indices in order to optimize the quality (i.e., accuracy) of the sound sensation of the audio signal as perceived by the cochlear implant patient… for example, decreasing the stimulation rate and using a multipolar (as opposed to monopolar) electrode configuration may produce a sound that is more tonal than noise-like)), and
the second operational settings are associated with a second electrode configuration (para. 0041 (increasing the stimulation rate and using a more monopolar electrode configuration may increase the quality of sound sensation of a sound that is more noise-like than tonal)).
Kulkarni and Litvack ’13 are considered to be analogous to the claimed invention because they are in the same field of cochlear implant systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni to incorporate the teachings of Litvack ’13 listed above and provide a first electrode configuration and a second electrode configuration for different operational settings. Doing so allows the electrode configuration to be selected based on the environment signals detected, thus optimizing the sound quality for the user.
Regarding claim 8, Kulkarni (in view of Litvack ‘13) teaches the method of claim 7, wherein the one or more parameters of the stimulation signals includes adjusting a number of stimulation channels (para. 0023 (a “stimulation channel” refers to a set of one or more electrodes by way of which electrical stimulation may be applied to a stimulation site within a cochlear implant patient. Because there may be multiple stimulation channels within a cochlear implant system, there may be multiple instances of a particular control parameter. For example, there may be a plurality of M levels each associated with a different stimulation channel)).
Kulkarni does not teach adjusting a number of stimulation channels that are stimulated in the first electrode configuration and the second electrode configuration.
Litvak ’13 teaches a first electrode configuration (para. 0041 (stimulation parameters may be dynamically adjusted in accordance with the determined tonality indices in order to optimize the quality (i.e., accuracy) of the sound sensation of the audio signal as perceived by the cochlear implant patient… for example, decreasing the stimulation rate and using a multipolar (as opposed to monopolar) electrode configuration may produce a sound that is more tonal than noise-like)), and
a second electrode configuration (para. 0041 (increasing the stimulation rate and using a more monopolar electrode configuration may increase the quality of sound sensation of a sound that is more noise-like than tonal)),
and adjusting a number of stimulation channels (para. 0034 (pairs or groups of individual electrodes 109 make up the M stimulation channels), 0042 (dynamically adjusting the electrode configuration and/or stimulation rate at which electrical stimulation pulses are applied to a stimulation site as the tonality of the audio signal changes over time)).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni to incorporate the teachings of Litvack ’13 listed above and provide an adjustment of a number of stimulation channels that are stimulated in the first and second electrode configuration. Doing so allows the appropriate amount of stimulation channels to be used that can provide the tonality of the audio signal, thus optimizing the sound quality for the user.
Regarding claim 31, Kulkarni teaches the medical device of claim 26, and the first set of operational settings (para. 0058 (M level (or any other control parameter), 0057 (detected amount of sound exposure is above a first threshold within the predetermined time period, processing facility 402 may increase the control parameter))
and the second set of operational settings (para. 0057 (detected amount of sound exposure is below a second threshold within the predetermined time period), 0058 (when the patient leaves the loud environment and enters a relatively quiet environment, processing facility 402 may decrease the M level associated with the patient)), and
wherein the stimulus adaption and smoothing module (Fig. 4, element 104 – sound processor) is configured to incrementally adjust a number of stimulation channels (para. 0023 (a “stimulation channel” refers to a set of one or more electrodes by way of which electrical stimulation may be applied to a stimulation site within a cochlear implant patient. Because there may be multiple stimulation channels within a cochlear implant system, there may be multiple instances of a particular control parameter. For example, there may be a plurality of M levels each associated with a different stimulation channel)).
Kulkarni does not teach wherein the first set of operational settings are associated with a first electrode configuration and the second set of operational settings are associated with a second electrode configuration, and wherein the stimulus adaption and smoothing module is configured to incrementally adjust a number of stimulation channels that are stimulated in the first electrode configuration and the second electrode configuration.
Litvak ’13 teaches a first electrode configuration (para. 0041 (stimulation parameters may be dynamically adjusted in accordance with the determined tonality indices in order to optimize the quality (i.e., accuracy) of the sound sensation of the audio signal as perceived by the cochlear implant patient… for example, decreasing the stimulation rate and using a multipolar (as opposed to monopolar) electrode configuration may produce a sound that is more tonal than noise-like)), and
a second electrode configuration (para. 0041 (increasing the stimulation rate and using a more monopolar electrode configuration may increase the quality of sound sensation of a sound that is more noise-like than tonal)),
and adjusting a number of stimulation channels (para. 0034 (pairs or groups of individual electrodes 109 make up the M stimulation channels), 0042 (dynamically adjusting the electrode configuration and/or stimulation rate at which electrical stimulation pulses are applied to a stimulation site as the tonality of the audio signal changes over time)).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni to incorporate the teachings of Litvack ’13 listed above and provide an adjustment of a number of stimulation channels that are stimulated in the first and second electrode configuration. Doing so allows the appropriate amount of stimulation channels to be used that can provide the tonality of the audio signal, thus optimizing the sound quality for the user.
Claims 9, 32, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni (US 20220008739 A1) and in view of Litvak (US 20150246230 A1), hereinafter Litvak ‘15.
Regarding claim 9, Kulkarni teaches the method of claim 1, and incrementally adjusting the one or more parameters of the stimulation signals (para. 0003 (an M level represents a stimulation current level required to achieve comfortable loudness to the patient), 0022 (a control parameter may be a threshold level (“T level”)… represents a minimum stimulation current level that produces a sensed perception of sound by the patient)) and stimulation channels (para. 0023 (a “stimulation channel” refers to a set of one or more electrodes by way of which electrical stimulation may be applied to a stimulation site within a cochlear implant patient. Because there may be multiple stimulation channels within a cochlear implant system, there may be multiple instances of a particular control parameter. For example, there may be a plurality of M levels each associated with a different stimulation channel)).
Kulkarni does not teach the one or more parameters of the stimulation signals including incrementally adjusting electrode weight applies to electrodes of one or more stimulation channels.
Litvack ‘15 teaches adjusting electrode weights applied to electrodes of one or more stimulation channels (para. 0021 (sound processor 104 may be configured to transcutaneously transmit one or more control parameters to auditory prosthesis 110… control parameters may be configured to specify one or more stimulation parameters, operating parameters, and/or any other parameter by which auditory prosthesis 110 is to operate as may serve a particular implementation. Exemplary control parameters include… electrode polarity parameters (i.e., anode-cathode assignment))).
Kulkarni and Litvack ’15 are considered to be analogous to the claimed invention because they are in the same field of cochlear implant systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni to incorporate the teachings of Litvack ’15 listed above and provide the adjustment of electrode weights to electrodes of stimulation channels. Doing so provides control over the stimulation channels, allowing stimulation to be delivered with the specified parameters.
Regarding claim 32, Kulkarni teaches the medical device of claim 26, and the stimulus adaption and smoothing module (Fig. 4, element 104 – sound processor) is configured to incrementally adjust stimulation parameter (para. 0054 (processing facility 402 may take into account an amount of sound exposure to the patient during a determined time period while gradually adjusting the M level (or any other control parameter) towards the target value)) and
stimulation channels (para. 0023 (a “stimulation channel” refers to a set of one or more electrodes by way of which electrical stimulation may be applied to a stimulation site within a cochlear implant patient. Because there may be multiple stimulation channels within a cochlear implant system, there may be multiple instances of a particular control parameter. For example, there may be a plurality of M levels each associated with a different stimulation channel)).
Kulkarni does not teach wherein the stimulus adaption and smoothing module is configured to incrementally adjust electrode weights applied to electrodes of one or more stimulation channels.
Litvack ’15 teaches adjusting electrode weights applied to electrodes of one or more stimulation channels (para. 0021 (sound processor 104 may be configured to transcutaneously transmit one or more control parameters to auditory prosthesis 110… control parameters may be configured to specify one or more stimulation parameters, operating parameters, and/or any other parameter by which auditory prosthesis 110 is to operate as may serve a particular implementation. Exemplary control parameters include… electrode polarity parameters (i.e., anode-cathode assignment))).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni to incorporate the teachings of Litvack ’15 listed above and provide the adjustment of electrode weights to electrodes of stimulation channels. Doing so provides control over the stimulation channels, allowing stimulation to be delivered with the specified parameters.
Regarding claim 35, Kulkarni teaches the medical device of claim 26, and the stimulus adaption and smoothing module (Fig. 4, element 108 – processing unit).
Kulkarni does not teach further comprising at least one battery, and wherein the stimulus adaption and smoothing module is configured to gradually adjust operation of the processing path based one or more attributes of the at least one battery.
Litvak ’15 teaches at least one battery (Fig. 5, element 504 – power supply facility), wherein the stimulus adaption and smoothing module (Fig. 3, element 104 – sound processor) is configured to gradually adjust operation of the processing path based one or more attributes of the at least one battery (para. 0069 (sound processor may determine that the auditory prosthesis patient is located within a particular environment (e.g., in a quiet room) … that does not require a relatively high auditory prosthesis performance level. At the same time, the sound processor may determine that the need for conserving power is relatively high (e.g., by determining that an available amount of power within a battery supplying power to the auditory prosthesis is below a predetermined threshold). In response, the sound processor may decrease… channels in order to reduce a compliance voltage that the auditory prosthesis has to maintain and thereby reduce power consumption by the auditory prosthesis)).,
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni to incorporate the teachings of Litvack ’15 listed above and provide a battery to the medical device, and allow the stimulus adaption and smoothing module to adjust the processing path based on the battery attributes. Doing so allows the processing stimulus adaption and smoothing module to determine the processing path that is best suited when the battery is full or low, to ensure that the patient is able to continue operating the medical device.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni (US 20220008739 A1).
Regarding claim 11, Kulkarni teaches the method of claim 1, wherein incrementally adjusting the one or more parameters includes adjusting at least one of the one or more parameters (para. 0054 (processing facility 402 may take into account an amount of sound exposure to the patient during a determined time period while gradually adjusting the M level (or any other control parameter) towards the target value), Fig. 5).
Kulkarni does not teach adjusting the one or more parameters in a stepwise manner. However, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni’s method to incorporate adjusting the one or more stimulation parameters in a stepwise manner. Although Kulkarni teaches the adjustment of the comfort level is a gradual linear increase shown in Fig. 5, Kulkarni also teaches that other adaption time courses may increase or decrease in any other manner (para. 0042). A person of ordinary skill in the art would have been motivated to adjust the one or more parameters of the stimulation signals in a stepwise manner, to allow the user to adjust to the current setting for a specified time period, before increasing the parameter again to reach the target value.
Claims 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni (US 20220008739 A1) and in view of Alfsmann et al. (US 20220249844 A1), hereinafter Alfsmann.
Regarding claim 15, Kulkarni teaches a processor (Fig. 1, element 104 – sound processor) to:
receive input signals para. 0025 (microphone 102 may be configured to detect audio signals presented to the patient), 0052 (processing facility 402 may take into account one or more other time-based and/or environmental-based factors)) at a medical device (Fig. 1, element 100 – cochlear implant system);
convert, using a first set of operational settings, the input signals to stimulation signals for delivery to a recipient of the medical device (para. 0026 (sound processor 104 may be configured to direct cochlear implant 108 to generate and apply electrical stimulation representative of one or more audio signals to one or more stimulation sites associated with an auditory pathway of the patient), 0058 (M level (or any other control parameter), 0057 (detected amount of sound exposure is above a first threshold within the predetermined time period, processing facility 402 may increase the control parameter));
determine to switch to a second set of operational settings (para. 0057 (detected amount of sound exposure is below a second threshold within the predetermined time period), 0058 (when the patient leaves the loud environment and enters a relatively quiet environment, processing facility 402 may decrease the M level associated with the patient)); and
gradually transition from use of the first set of operational settings to use of the second set of operational settings by incrementally adjusting parameters used to deliver the stimulation signals to the recipient (0054 (processing facility 402 may take into account an amount of sound exposure to the patient during a determined time period while gradually adjusting the M level (or any other control parameter) towards the target value)).
Kulkarni does not teach one or more non-transitory computer readable storage media comprising instructions.
Alfsmann teaches a medical device (Fig. 1, element 100 – cochlear implant system) comprising one or more non-transitory computer readable storage media (para. 0031 (Memory 112 may be implemented by any suitable non-transitory computer-readable medium and/or non-transitory processor-readable medium)) comprising instructions, that can be executed by a processor (Fig. 1, element 114 – processor, para. 0032 (memory 112 may store instructions 116 that may be executed by processor 114 to perform any of the audio content processing and cochlear implant control operations)).
Kulkarni and Alfsmann are considered to be analogous to the claimed invention because they are in the same field of cochlear implant systems. Kulkarni teaches a storage facility (Fig. 4, element 404) that maintains data and can be implemented by a processor to perform its functions (para. 0036). Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni to incorporate the teachings of Alfsmann listed above and provide a non-transitory computer readable storage media comprising instructions to be executed by a processor. Doing so increases the storage capacity, allowing data comprising specific stimulation parameters to be stored.
Regarding claim 16, Kulkarni (in view of Alfsmann) teaches the one or more non-transitory computer readable storage media of claim 15, wherein, when gradually transitioning from use of the first set of operational settings to use of the second set of operational settings, the instructions further cause the processor to incrementally adjust one or more of a threshold level, a comfort level, or a volume level associated with the stimulation signals (para. 0003 (an M level represents a stimulation current level required to achieve comfortable loudness to the patient), 0022 (a control parameter may be a threshold level (“T level”)… represents a minimum stimulation current level that produces a sensed perception of sound by the patient)).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni (US 20220008739 A1) and in view of Alfsmann (US 20220249844 A1), and in further view of Smith (US 10743114 B2).
Regarding claim 17, Kulkarni (in view of Alfsmann) teaches the one or more non-transitory computer readable storage media of claim 15, wherein, when gradually transitioning from use of the first set of operational settings to use of the second set of operational settings (para. 0057 (detected amount of sound exposure is below a second threshold within the predetermined time period), 0058 (when the patient leaves the loud environment and enters a relatively quiet environment, processing facility 402 may decrease the M level associated with the patient)),
the instructions further cause the processor (Fig. 1, element 104 – sound processor) to incrementally adjust stimulation parameters (para. 0054 (processing facility 402 may take into account an amount of sound exposure to the patient during a determined time period while gradually adjusting the M level (or any other control parameter) towards the target value)).
Kulkarni does not teach adjusting a stimulus resolution of the stimulation signals.
Smith teaches adjusting a stimulus resolution of the stimulation signals (col. 10, lines 60-66 (stimulus resolution adaption module 168 may determine the target stimulus resolution and make corresponding processing adjusts in response to a triggering event, such as the detection of a change in the listening environment)).
Kulkarni, Alfsmann, and Smith are all considered to be analogous to the claimed invention because they are in the same field of cochlear implant systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni to incorporate the teachings of Smith listed above and adjusting a stimulus resolution of the stimulation signals. Doing so allows the resolution of the stimulation signals to be adjusted based on the detected environment signals, allowing the sound processor to deliver the stimulation signals appropriately.
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni (US 20220008739 A1) and in view of Alfsmann (US 20220249844 A1), and in further view of Litvak ’13 (US 20130197606 A1).
Regarding claim 21, Kulkarni (in view of Alfsmann) teaches the one or more non-transitory computer readable storage media of claim 15, and the first operational settings (para. 0058 (M level (or any other control parameter), 0057 (detected amount of sound exposure is above a first threshold within the predetermined time period, processing facility 402 may increase the control parameter)) and the second operation settings (para. 0057 (detected amount of sound exposure is below a second threshold within the predetermined time period), 0058 (when the patient leaves the loud environment and enters a relatively quiet environment, processing facility 402 may decrease the M level associated with the patient)).
Kulkarni does not teach wherein the first set of operational settings are associated with a first electrode configuration and the second set of operational settings are associated with a second electrode configuration.
Litvak ’13 teaches first operational settings are associated with a first electrode configuration (para. 0041 (stimulation parameters may be dynamically adjusted in accordance with the determined tonality indices in order to optimize the quality (i.e., accuracy) of the sound sensation of the audio signal as perceived by the cochlear implant patient… for example, decreasing the stimulation rate and using a multipolar (as opposed to monopolar) electrode configuration may produce a sound that is more tonal than noise-like)), and
the second operational settings are associated with a second electrode configuration (para. 0041 (increasing the stimulation rate and using a more monopolar electrode configuration may increase the quality of sound sensation of a sound that is more noise-like than tonal)).
Kulkarni, Alfsmann, and Litvack ’13 are all considered to be analogous to the claimed invention because they are in the same field of cochlear implant systems. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni to incorporate the teachings of Litvack ’13 listed above and provide a first electrode configuration and a second electrode configuration for different operational settings. Doing so allows the electrode configuration to be selected based on the environment signals detected, thus optimizing the sound quality for the user.
Regarding claim 22, Kulkarni (in view of Alfsmann and ) teaches the one or more non-transitory computer readable storage media of claim 21, and gradually transitioning from use of the first set of operational settings to use of the second set of operational settings (0054 (processing facility 402 may take into account an amount of sound exposure to the patient during a determined time period while gradually adjusting the M level (or any other control parameter) towards the target value)) and the processor (Fig. 4, element 104 - sound processor) and adjusting a number of stimulation channels (para. 0023 (a “stimulation channel” refers to a set of one or more electrodes by way of which electrical stimulation may be applied to a stimulation site within a cochlear implant patient. Because there may be multiple stimulation channels within a cochlear implant system, there may be multiple instances of a particular control parameter. For example, there may be a plurality of M levels each associated with a different stimulation channel)).
Kulkarni does not teach when gradually transitioning from use of the first set of operational settings to use of the second set of operational settings, the instructions further cause the processor to incrementally adjust a number of stimulation channels that are stimulated in the first electrode configuration and the second electrode configuration.
Litvak ’13 teaches a first electrode configuration (para. 0041 (stimulation parameters may be dynamically adjusted in accordance with the determined tonality indices in order to optimize the quality (i.e., accuracy) of the sound sensation of the audio signal as perceived by the cochlear implant patient… for example, decreasing the stimulation rate and using a multipolar (as opposed to monopolar) electrode configuration may produce a sound that is more tonal than noise-like)), and
a second electrode configuration (para. 0041 (increasing the stimulation rate and using a more monopolar electrode configuration may increase the quality of sound sensation of a sound that is more noise-like than tonal)),
and adjusting a number of stimulation channels (para. 0034 (pairs or groups of individual electrodes 109 make up the M stimulation channels), 0042 (dynamically adjusting the electrode configuration and/or stimulation rate at which electrical stimulation pulses are applied to a stimulation site as the tonality of the audio signal changes over time)).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni to incorporate the teachings of Litvack ’13 listed above and provide an adjustment of a number of stimulation channels that are stimulated in the first and second electrode configuration. Doing so allows the appropriate amount of stimulation channels to be used that can provide the tonality of the audio signal, thus optimizing the sound quality for the user.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Kulkarni (US 20220008739 A1) and in view of Alfsmann (US 20220249844 A1), and in further view of Litvak ’15 (US 20150246230 A1).
Regarding claim 23, Kulkarni (in view of Alfsmann) teaches the one or more non-transitory computer readable storage media of claim 15, wherein, when gradually transitioning from use of the first set of operational settings to use of the second set of operational settings (para. 0054 (processing facility 402 may take into account an amount of sound exposure to the patient during a determined time period while gradually adjusting the M level (or any other control parameter) towards the target value)), and
the processor (Fig. 4, element 104 – sound processor) configured to incrementally adjust stimulation parameter (para. 0054 (processing facility 402 may take into account an amount of sound exposure to the patient during a determined time period while gradually adjusting the M level (or any other control parameter) towards the target value)) and
stimulation channels (para. 0023 (a “stimulation channel” refers to a set of one or more electrodes by way of which electrical stimulation may be applied to a stimulation site within a cochlear implant patient. Because there may be multiple stimulation channels within a cochlear implant system, there may be multiple instances of a particular control parameter. For example, there may be a plurality of M levels each associated with a different stimulation channel)).
Kulkarni does not teach the instructions further cause the processor to incrementally adjust electrode weights applied to electrodes of one or more stimulation channels.
Litvack ’15 teaches adjusting electrode weights applied to electrodes of one or more stimulation channels (para. 0021 (sound processor 104 may be configured to transcutaneously transmit one or more control parameters to auditory prosthesis 110… control parameters may be configured to specify one or more stimulation parameters, operating parameters, and/or any other parameter by which auditory prosthesis 110 is to operate as may serve a particular implementation. Exemplary control parameters include… electrode polarity parameters (i.e., anode-cathode assignment))).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Kulkarni to incorporate the teachings of Litvack ’15 listed above and provide the adjustment of electrode weights to electrodes of stimulation channels. Doing so provides control over the stimulation channels, allowing stimulation to be delivered with the specified parameters.
Conclusion
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/EILEEN ROBLES/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
