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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 23 Jan 2026 has been entered.
This Office Action is responsive to the amendment filed on 23 Jan 2026. As directed by the amendment: claims 1, 3, 9, 12, 21, and 24 have been amended, no claims have been canceled, and no claims have been added. Thus, claims 1-25 are presently pending in this application.
Response to Arguments
Claim Objections
Applicant’s arguments, see Remarks, filed 23 Jan 2026, with respect to objections to the claims have been fully considered and are persuasive in light of the claim amendments. The objections to the claims have been withdrawn.
Claim Rejections Under 35 U.S.C §112
Applicant’s arguments, see Remarks, filed 23 Jan 2026, with respect to the rejections of the claims under 35 U.S.C. 112 have been fully considered and are persuasive in light of the claim amendments. The rejections of the claims under 35 U.S.C. 112 have been withdrawn.
However, new rejections under 35 U.S.C. 112 are made below.
Claim Rejections Under 35 U.S.C. § 102
Applicant’s arguments, see Remarks, filed 23 Jan 2026, with respect to the rejections of claims 1 and 12 under 35 U.S.C. 102 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Keller et al. (US 8843217 B1, previously cited), hereinafter Keller, as explained in further detail below.
Claim Rejections Under 35 U.S.C. § 103
Applicant’s arguments, see Remarks, filed 23 Jan 2026, with respect to the rejections of claim 21 under 35 U.S.C. 103 have been fully considered and are persuasive in light of the claim amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Keller et al. (US 8843217 B1, previously cited), hereinafter Keller, as explained in further detail below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-4 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites that “the method further includes at least one of initiating cochlear stimulation of the cochlea or initiating vestibular stimulation of the vestibular system”. Under the broadest reasonable interpretation of the claim, only one of the two options is required.
Claim 3 recites that “both the cochlear stimulation and the vestibular stimulation are initiated”, which contradicts the requirement of claim 2 that only one stimulation is initiated. Therefore, claim 3 is indefinite.
Claim 4 is also rejected because it is dependent on claim 3.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 6, 9, 12-15, 17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Keller et al. (US 8843217 B1, previously cited), hereinafter Keller.
Regarding claim 1, Keller discloses a method comprising:
obtaining cochlear biological state data of a cochlea with a cochlear sensor configured to be implanted in a recipient, wherein the cochlear biological state data comprises first neural response data (column 12, lines 38-45, "system 601 controls the triggering of nerve-action potentials (NAPs) in the nerves of the cochlea and/or vestibular system (for example, in some embodiments, system 601 controls the delivery of optical-stimulation signals (e.g., INS signals) that trigger an electrical response in one cochlear nerve or a small subset of cochlear nerves, and that response is detected using one or more electrodes in device 610");
obtaining vestibular electrophysiological data of a vestibular system with a vestibular sensor configured to be implanted in the recipient, wherein the vestibular electrophysiological data comprises second neural response data (column 14, lines 4-5, "detecting a background-NAP rate associated with the selected vestibular neuron"); and
modifying a stimulation provided to the recipient based on both the first neural response data and the second neural response data (column 8, lines 4-9, "one or both of VI portion 210 and CI portion 220 includes one or more sensors (not shown) configured to detect the NAPs triggered by the stimulation signals delivered by stimulation sources 211 and provide feedback to controller 232 in order to more effectively stimulate the desired nerve tissues"; column 11, lines 36-40, "controller 232 processes the received background-rate signals and automatically controls system 501 to deliver the stimulation or inhibition signals necessary to provide an appropriate balance sensation to the person using system 501").
Regarding claim 2, Keller discloses the method of claim 1, as explained above. Keller further discloses that the method further includes at least one of initiating cochlear stimulation of the cochlea (column 15, lines 55-61, "a first plurality of electrodes configured to generate a first plurality of electrical signals that, when applied to the plurality of cochlear neurons including the selected cochlear neuron, sensitize the plurality of cochlear neurons; a third transmission medium configured to deliver the first plurality of electrical signals to the plurality of cochlear neurons") or initiating vestibular stimulation of the vestibular system (column 15, lines 61-65, "a second plurality of electrodes configured to generate a second plurality of electrical signals that, when applied to the plurality of vestibular neurons including the selected vestibular neuron, sensitize the plurality of vestibular neurons").
Regarding claim 6, Keller discloses the method of claim 1, as explained above. Keller further discloses that modifying the stimulation comprises modifying a stimulation provided to the vestibular system or the cochlea (column 8, lines 4-9, "one or both of VI portion 210 and CI portion 220 includes one or more sensors (not shown) configured to detect the NAPs triggered by the stimulation signals delivered by stimulation sources 211 and provide feedback to controller 232 in order to more effectively stimulate the desired nerve tissues").
Regarding claim 9, Keller discloses the method of claim 1, as explained above. Keller further discloses that obtaining the cochlear biological state data or the vestibular electrophysiological data includes:
initiating cochlear stimulation with a cochlear electrode (column 15, lines 55-61, "a first plurality of electrodes configured to generate a first plurality of electrical signals that, when applied to the plurality of cochlear neurons including the selected cochlear neuron, sensitize the plurality of cochlear neurons; a third transmission medium configured to deliver the first plurality of electrical signals to the plurality of cochlear neurons") or applying vestibular stimulation with a vestibular electrode (column 15, lines 61-65, "a second plurality of electrodes configured to generate a second plurality of electrical signals that, when applied to the plurality of vestibular neurons including the selected vestibular neuron, sensitize the plurality of vestibular neurons"); and
measuring the first neural response data resulting from the cochlear stimulation or the second neural response data resulting from the vestibular stimulation (column 12, lines 38-45, "system 601 controls the triggering of nerve-action potentials (NAPs) in the nerves of the cochlea and/or vestibular system (for example, in some embodiments, system 601 controls the delivery of optical-stimulation signals (e.g., INS signals) that trigger an electrical response in one cochlear nerve or a small subset of cochlear nerves, and that response is detected using one or more electrodes in device 610"; column 14, lines 4-5, "detecting a background-NAP rate associated with the selected vestibular neuron").
Regarding claim 12, Keller discloses a system (Fig. 2A, vestibular-cochlear stimulation system 201) comprising:
one or more processors (Fig. 2A, processor/controller 232) configured to:
obtain cochlear biological state data of a cochlea from a cochlear sensor configured to be implanted in a recipient, wherein the cochlear biological state data comprises first neural response data (column 12, lines 38-45, "system 601 controls the triggering of nerve-action potentials (NAPs) in the nerves of the cochlea and/or vestibular system (for example, in some embodiments, system 601 controls the delivery of optical-stimulation signals (e.g., INS signals) that trigger an electrical response in one cochlear nerve or a small subset of cochlear nerves, and that response is detected using one or more electrodes in device 610");
obtain vestibular electrophysiological data of a vestibular system from a vestibular sensor configured to be implanted in the recipient, wherein the vestibular electrophysiological data comprises second neural response data (column 14, lines 4-5, "detecting a background-NAP rate associated with the selected vestibular neuron"); and
modify a stimulation provided to the recipient based on both the first neural response data and the second neural response data (column 8, lines 4-9, "one or both of VI portion 210 and CI portion 220 includes one or more sensors (not shown) configured to detect the NAPs triggered by the stimulation signals delivered by stimulation sources 211 and provide feedback to controller 232 in order to more effectively stimulate the desired nerve tissues"; column 11, lines 36-40, "controller 232 processes the received background-rate signals and automatically controls system 501 to deliver the stimulation or inhibition signals necessary to provide an appropriate balance sensation to the person using system 501").
Regarding claim 13, Keller discloses the system of claim 12, as explained above. Keller further discloses that the system further comprises:
the cochlear sensor (column 8, lines 4-8, "one or both of VI portion 210 and CI portion 220 includes one or more sensors (not shown) configured to detect the NAPs triggered by the stimulation signals delivered by stimulation sources 211"; column 12, lines 41-45, "system 601 controls the delivery of optical-stimulation signals (e.g., INS signals) that trigger an electrical response in one cochlear nerve or a small subset of cochlear nerves, and that response is detected using one or more electrodes in device 610");
the vestibular sensor (column 8, lines 4-8, "one or both of VI portion 210 and CI portion 220 includes one or more sensors (not shown) configured to detect the NAPs triggered by the stimulation signals delivered by stimulation sources 211"; column 11, lines 32-34, "system 501 includes one or more sensors 512 configured to sense the background firing rate of the vestibular system"); and
an implantable medical device coupled to both the cochlear sensor and the vestibular sensor (column 7, lines 52-54, "system 201 includes a vestibular-implant (VI) portion 210 and a cochlear-implant (CI) portion 220"; column 8, line 66-column 9, line 3, "VI portion 210 and CI portion 220 are integrated together in one continuous implant such that CI portion 220 is operatively coupled directly to VI portion 210, which in turn is operatively coupled to controller 232").
Regarding claim 14, Keller discloses the system of claim 13, as explained above. Keller further discloses that the cochlear sensor is a cochlear electrode configured to be implanted in the cochlea of the recipient (column 9, lines 4-7, "CI portion 220 is inserted into cochlea 180 by passing CI portion 220 through vestibule 145 (in some embodiments, via an incision through oval window 146) and into the scala vestibuli of cochlea 180"; column 12, lines 41-45, "system 601 controls the delivery of optical-stimulation signals (e.g., INS signals) that trigger an electrical response in one cochlear nerve or a small subset of cochlear nerves, and that response is detected using one or more electrodes in device 610"), and wherein the vestibular sensor is a vestibular electrode configured to be implanted in the recipient (column 9, lines 7-9, "VI portion 210 (which is located between CI portion 220 and controller 232) is placed inside vestibule 145").
Regarding claim 15, Keller discloses the system of claim 13, as explained above. Keller further discloses that the one or more processors are further configured to: transmit an instruction to the implantable medical device via one or more intermediary devices, wherein the instruction is configured to apply a treatment modification to the implantable medical device (column 12, lines 29-38, "system 601 includes an audiologist-, surgeon- and/or user-control console computer 20 that is programmable and that has a wireless (or wired, optical fiber, or other direct connection) transceiver 71 that allows wireless control of, and/or sensing from (i.e., reprogramming of the remote microprocessors, as well as receiving sensed signals and diagnostic information from), the implanted vestibular-cochlear stimulation device 610 (which, in some embodiments, includes a programmed microcontroller such as controller 232 of FIG. 2A)").
Regarding claim 17, Keller discloses the system of claim 12, as explained above. Keller further discloses that the one or more processors are configured to: modify the stimulation provided to the vestibular system or the cochlea based on both the cochlear biological state data and the vestibular electrophysiological data (column 8, lines 4-9, "one or both of VI portion 210 and CI portion 220 includes one or more sensors (not shown) configured to detect the NAPs triggered by the stimulation signals delivered by stimulation sources 211 and provide feedback to controller 232 in order to more effectively stimulate the desired nerve tissues").
Regarding claim 20, Keller discloses the system of claim 12, as explained above. Keller further discloses that the system further comprises an implantable biocompatible housing and wherein the implantable biocompatible housing includes the one or more processors (column 8, lines 20-22, "single device enclosure 230 that houses a single multi-function processor/controller 232").
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3-4 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Keller et al. (US 8843217 B1, previously cited), hereinafter Keller.
Regarding claim 3, Keller discloses the method of claim 2, as explained above. Keller further discloses that wherein both the cochlear stimulation and the vestibular stimulation are initiated, and wherein obtaining the cochlear biological state data includes obtaining the first neural response data from the cochlear sensor, wherein obtaining the vestibular electrophysiological data includes obtaining the second neural response data from the vestibular sensor, and wherein the method further includes measuring the first neural response data resulting from the cochlear stimulation or the second neural response data resulting from the vestibular stimulation (column 12, lines 38-45, "system 601 controls the triggering of nerve-action potentials (NAPs) in the nerves of the cochlea and/or vestibular system (for example, in some embodiments, system 601 controls the delivery of optical-stimulation signals (e.g., INS signals) that trigger an electrical response in one cochlear nerve or a small subset of cochlear nerves, and that response is detected using one or more electrodes in device 610"; column 14, lines 4-5, "detecting a background-NAP rate associated with the selected vestibular neuron").
Keller does not explicitly disclose that the one or more processors are configured to obtain cochlear biological state data of the recipient's cochlea while reducing the delivery of stimulation of the recipient's vestibular system, and obtain vestibular biological state data of the recipient's vestibular system while reducing the delivery of stimulation to the recipient's cochlea.
However, under a broad reasonable interpretation, "modifying" stimulation includes reducing stimulation. Therefore, Keller's disclosure of “modifying” stimulation based on the nerve action potentials obviates the limitation of “reducing” stimulation.
Regarding claim 4, the method of claim 3 is obvious over Keller, as explained above. Keller further discloses that the cochlear sensor is a cochlear electrode (Fig. 2A, column 7, lines 59-61, "cochlea-stimulation sources 221...include...a plurality of electrodes"), and
wherein initiating cochlear stimulation of the cochlea includes applying the cochlear stimulation with the cochlear electrode (column 15, lines 55-61, "a first plurality of electrodes configured to generate a first plurality of electrical signals that, when applied to the plurality of cochlear neurons including the selected cochlear neuron, sensitize the plurality of cochlear neurons; a third transmission medium configured to deliver the first plurality of electrical signals to the plurality of cochlear neurons"),
wherein the vestibular sensor is a vestibular electrode (Fig. 2A, column 7, lines 55-58, "vestibular-stimulation sources 211...include...a plurality of electrodes"), and
wherein causing vestibular stimulation includes applying the vestibular stimulation with the vestibular electrode (column 15, lines 61-65, "a second plurality of electrodes configured to generate a second plurality of electrical signals that, when applied to the plurality of vestibular neurons including the selected vestibular neuron, sensitize the plurality of vestibular neurons").
Regarding claim 21, Keller discloses an apparatus (Fig. 2A, vestibular-cochlear stimulation system 201) comprising:
an implantable cochlear electrode (Fig. 2A, column 7, lines 59-61, "cochlea-stimulation sources 221...include...a plurality of electrodes");
an implantable vestibular electrode (Fig. 2A, column 7, lines 55-58, "vestibular-stimulation sources 211...include...a plurality of electrodes"); and
one or more processors (Fig. 2A, processor/controller 232) configured to:
initiate delivery of stimulation to a recipient's cochlea via the implantable cochlear electrode (column 15, lines 55-61, "a first plurality of electrodes configured to generate a first plurality of electrical signals that, when applied to the plurality of cochlear neurons including the selected cochlear neuron, sensitize the plurality of cochlear neurons; a third transmission medium configured to deliver the first plurality of electrical signals to the plurality of cochlear neurons");
initiate delivery of stimulation to the recipient's vestibular system via the implantable vestibular electrode (column 15, lines 61-65, "a second plurality of electrodes configured to generate a second plurality of electrical signals that, when applied to the plurality of vestibular neurons including the selected vestibular neuron, sensitize the plurality of vestibular neurons");
obtain cochlear biological state data of the recipient's cochlea (column 12, lines 38-45, "system 601 controls the triggering of nerve-action potentials (NAPs) in the nerves of the cochlea and/or vestibular system (for example, in some embodiments, system 601 controls the delivery of optical-stimulation signals (e.g., INS signals) that trigger an electrical response in one cochlear nerve or a small subset of cochlear nerves, and that response is detected using one or more electrodes in device 610");
obtain vestibular biological state data of the recipient's vestibular system (column 14, lines 4-5, "detecting a background-NAP rate associated with the selected vestibular neuron"); and
modify at least one of the stimulation delivered to the recipient's cochlea or the stimulation delivered to the recipient's vestibular system based on both the cochlear biological state data and the vestibular biological state data (column 8, lines 4-9, "one or both of VI portion 210 and CI portion 220 includes one or more sensors (not shown) configured to detect the NAPs triggered by the stimulation signals delivered by stimulation sources 211 and provide feedback to controller 232 in order to more effectively stimulate the desired nerve tissues"; column 11, lines 36-40, "controller 232 processes the received background-rate signals and automatically controls system 501 to deliver the stimulation or inhibition signals necessary to provide an appropriate balance sensation to the person using system 501").
Keller does not explicitly disclose that the one or more processors are configured to obtain cochlear biological state data of the recipient's cochlea while reducing the delivery of stimulation of the recipient's vestibular system, and obtain vestibular biological state data of the recipient's vestibular system while reducing the delivery of stimulation to the recipient's cochlea.
However, under a broad reasonable interpretation, "modifying" stimulation includes reducing stimulation. Therefore, Keller's disclosure of “modifying” stimulation based on the nerve action potentials obviates the limitation of “reducing” stimulation.
Regarding claim 22, the apparatus of claim 21 is obvious over Keller, as explained above. Keller further discloses that the one or more processors are configured to obtain the cochlear biological state data using the implantable cochlear electrode in response to the delivery of stimulation to the recipient's cochlea (column 12, lines 38-45, "system 601 controls the triggering of nerve-action potentials (NAPs) in the nerves of the cochlea and/or vestibular system (for example, in some embodiments, system 601 controls the delivery of optical-stimulation signals (e.g., INS signals) that trigger an electrical response in one cochlear nerve or a small subset of cochlear nerves, and that response is detected using one or more electrodes in device 610"), and to obtain the vestibular biological state data using the implantable vestibular electrode in response to the delivery of stimulation to the recipient's vestibular system (column 14, lines 4-5, "detecting a background-NAP rate associated with the selected vestibular neuron").
Regarding claim 23, the apparatus of claim 21 is obvious over Keller, as explained above. Keller further discloses:
a cochlear carrier on which the implantable cochlear electrode is disposed (Fig. 2A, CI portion 220);
a vestibular carrier on which the implantable vestibular electrode is disposed (Fig. 2A, VI portion 210); and
an implantable biocompatible housing in which the one or more processors are disposed (Fig. 2A, column 8, lines 20-21, "system 201 includes a single device enclosure 230 that houses a single multi-function processor/controller 232"),
wherein the cochlear carrier and the vestibular carrier are coupled to the implantable biocompatible housing (column 8, lines 21-23, "processor/controller 232 (e.g., a micro-controller) configured to control both VI portion 210 and CI portion 220").
Regarding claim 24, the apparatus of claim 21 is obvious over Keller, as explained above. Keller further discloses that the one or more processors are further configured to:
continue the delivery of stimulation to the recipient's cochlea while reducing the delivery of stimulation to the recipient's vestibular system to obtain the cochlear biological state data (column 17, lines 42-46, "selectively controlling the first and second plurality of electrical signals to sensitize the one or more cochlear and vestibular neurons in order to control NAPs produced by the one or more cochlear and vestibular neurons"); and
continue the delivery of stimulation to the recipient's vestibular system while reducing the delivery of stimulation to the recipient's cochlea to obtain the vestibular biological state data (column 17, lines 42-46, "selectively controlling the first and second plurality of electrical signals to sensitize the one or more cochlear and vestibular neurons in order to control NAPs produced by the one or more cochlear and vestibular neurons").
Keller does not explicitly disclose that the one or more processors are configured to obtain cochlear biological state data of the recipient's cochlea while reducing the delivery of stimulation of the recipient's vestibular system, and obtain vestibular biological state data of the recipient's vestibular system while reducing the delivery of stimulation to the recipient's cochlea.
However, under a broad reasonable interpretation, "modifying" stimulation includes reducing stimulation. Therefore, Keller's disclosure of “modifying” stimulation based on the nerve action potentials obviates the limitation of “reducing” stimulation.
Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Keller et al. (US 8843217 B1, previously cited), hereinafter Keller, in view of Heasman et al. (US 20200238002 A1), hereinafter Heasman 2020.
Regarding claim 5, Keller discloses the method of claim 1, as explained above. Keller does not explicitly disclose applying a drug based on both the cochlear biological state data and the vestibular electrophysiological data.
However, Heasman 2020 teaches an implantable drug delivery system (Fig. 3, paragraph [0068]) for delivering treatment substances to an inner ear of a recipient (Abstract), wherein a drug is applied (paragraph [0077], "based on the analysis of the in-vivo biomarkers 350, the processor 368 is configured to generate an appropriate treatment substance control output") based on both the cochlear biological state data (paragraphs [0032]-[0033], [0074]) and the vestibular electrophysiological data (paragraph [0108] and following table, "By monitoring the vestibular nerve or the hair cell activity within the vestibular system it is possible to track the magnitude of the nystagmus").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Keller with the teachings of Heasman 2020 to apply a drug based on both the cochlear biological state data and the vestibular electrophysiological data, because doing so ensures that delivery of the treatment substances remains in a selected/desired treatment window (i.e., is clinically effective and does not have toxic effects) (Heasman 2020, paragraph [0021]).
Regarding claim 16, Keller discloses the system of claim 12, as explained above. Keller does not explicitly disclose applying a drug based on both the cochlear biological state data and the vestibular electrophysiological data.
However, Heasman 2020 teaches an implantable drug delivery system (Fig. 3, paragraph [0068]) for delivering treatment substances to an inner ear of a recipient (Abstract), wherein a drug is applied (paragraph [0077], "based on the analysis of the in-vivo biomarkers 350, the processor 368 is configured to generate an appropriate treatment substance control output") based on both the cochlear biological state data (paragraphs [0032]-[0033], [0074]) and the vestibular electrophysiological data (paragraph [0108] and following table, "By monitoring the vestibular nerve or the hair cell activity within the vestibular system it is possible to track the magnitude of the nystagmus").
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Keller with the teachings of Heasman 2020 to apply a drug based on both the cochlear biological state data and the vestibular electrophysiological data, because doing so ensures that delivery of the treatment substances remains in a selected/desired treatment window (i.e., is clinically effective and does not have toxic effects) (Heasman 2020, paragraph [0021]).
Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Keller et al. (US 8843217 B1, previously cited), hereinafter Keller, in view of Heasman et al. (US 20170360364 A1, previously cited), hereinafter Heasman 2017.
Regarding claim 7, Keller discloses the method of claim 1, as explained above. Keller does not explicitly disclose that obtaining the cochlear biological state data includes: obtaining data regarding an impedance associated with stimulating the cochlea.
However, Heasman 2017 teaches techniques for monitoring a recipient's cochlear health (Abstract) including obtaining the cochlear biological state data includes obtaining data regarding an impedance associated with stimulating the cochlea (paragraphs [0040], [0057], [0060]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Keller with the teachings of Heasman 2017 so that the cochlear biological state data or the vestibular biological state data includes data regarding an impedance associated with cochlear or vestibular stimulation, because doing so allows the system to determine whether the inner ear has altered in its health or function, to diagnose the root cause of the change, and to determine the best treatment for the recipient (Heasman 2017, paragraphs [0042], [0061]).
Regarding claim 18, Keller discloses the system of claim 12, as explained above. Keller does not explicitly disclose that the cochlear biological state data or the vestibular electrophysiological data includes data regarding an impedance associated with cochlear or vestibular stimulation.
However, Heasman 2017 teaches techniques for monitoring a recipient's cochlear health (Abstract) including obtaining the cochlear biological state data includes obtaining data regarding an impedance associated with stimulating the cochlea (paragraphs [0040], [0057], [0060]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Keller with the teachings of Heasman 2017 so that the cochlear biological state data or the vestibular biological state data includes data regarding an impedance associated with cochlear or vestibular stimulation, because doing so allows the system to determine whether the inner ear has altered in its health or function, to diagnose the root cause of the change, and to determine the best treatment for the recipient (Heasman 2017, paragraphs [0042], [0061]).
Regarding claim 25, the apparatus of claim 21 is obvious over Keller, as explained above. Keller does not explicitly disclose that obtaining the cochlear biological state data includes: obtaining data regarding an impedance associated with stimulating the cochlea.
However, Heasman 2017 teaches techniques for monitoring a recipient's cochlear health (Abstract) including obtaining the cochlear biological state data includes obtaining data regarding an impedance associated with stimulating the cochlea (paragraphs [0040], [0057], [0060]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Keller with the teachings of Heasman 2017 so that the cochlear biological state data or the vestibular biological state data includes data regarding an impedance associated with cochlear or vestibular stimulation, because doing so allows the system to determine whether the inner ear has altered in its health or function, to diagnose the root cause of the change, and to determine the best treatment for the recipient (Heasman 2017, paragraphs [0042], [0061]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Keller et al. (US 8843217 B1, previously cited), hereinafter Keller, in view of Della Santina et al. (US 20130131761 A1, previously cited), hereinafter Della Santina.
Regarding claim 8, Keller discloses the method of claim 1, as explained above. Keller does not explicitly disclose that obtaining the vestibular electrophysiological data of the vestibular system includes: obtaining data regarding an impedance associated with stimulating the vestibular system.
However, Della Santina teaches a multichannel vestibular prosthesis (Abstract) wherein obtaining vestibular biological state data of the vestibular system includes obtaining data regarding an impedance associated with stimulating the vestibular system (paragraphs [0031], [0062]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Keller with the teachings of Della Santina so that obtaining the vestibular biological state data of the vestibular system includes: obtaining data regarding an impedance associated with stimulating the vestibular system, because doing so allows the device to provide real-time feedback to ensure stimuli adhere to safe stimulation criteria (Della Santina, paragraph [0031]).
Claims 10 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Keller et al. (US 8843217 B1, previously cited), hereinafter Keller, in view of Lattner et al. (WO 0066215 A1, previously cited), hereinafter Lattner.
Regarding claim 10, Keller discloses the method of claim 1, as explained above. Keller does not explicitly disclose providing the cochlear biological state data and the vestibular electrophysiological data as inputs to an artificial intelligence framework; obtaining an output from the artificial intelligence framework; and using the output from the artificial intelligence framework to modify the stimulation provided to the recipient.
However, Lattner teaches a vestibular stimulating system (Abstract) wherein the system provides the cochlear biological state data and the vestibular biological state data as inputs to an artificial intelligence framework; obtains an output from the artificial intelligence framework; and uses the output from the artificial intelligence framework to modify the stimulation provided to the recipient (page 13, lines 12-26).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Keller with the teachings of Lattner to provide the cochlear biological state data and the vestibular electrophysiological data as inputs to an artificial intelligence framework; obtain an output from the artificial intelligence framework; and use the output from the artificial intelligence framework to modify the stimulation provided to the recipient, because doing so allows the patient to easily adapt stimulation parameters to their own desired levels (Lattner, page 13, lines 12-21).
Regarding claim 19, Keller discloses the system of claim 12, as explained above. Keller does not explicitly disclose that the one or more processors are configured to: provide the cochlear biological state data and the vestibular electrophysiological data as input into an artificial intelligence framework; and obtain an output from the artificial intelligence framework, wherein the stimulation is modified based on the output from the artificial intelligence framework.
However, Lattner teaches a vestibular stimulating system (Abstract) wherein the system provides the cochlear biological state data and the vestibular biological state data as inputs to an artificial intelligence framework; obtains an output from the artificial intelligence framework; and uses the output from the artificial intelligence framework to modify the stimulation provided to the recipient (page 13, lines 12-26).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Keller with the teachings of Lattner to provide the cochlear biological state data and the vestibular electrophysiological data as inputs to an artificial intelligence framework; obtain an output from the artificial intelligence framework; and use the output from the artificial intelligence framework to modify the stimulation provided to the recipient, because doing so allows the patient to easily adapt stimulation parameters to their own desired levels (Lattner, page 13, lines 12-21).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Keller et al. (US 8843217 B1, previously cited), hereinafter Keller, in view of Chambers et al. (US 20120226332 A1, previously cited), hereinafter Chambers.
Regarding claim 11, Keller discloses the method of claim 1, as explained above. Keller does not explicitly disclose that obtaining the cochlear biological state data includes performing the obtaining at a time based on the stimulation provided to the recipient, and wherein obtaining the vestibular electrophysiological data includes performing the obtaining at an additional time based on the stimulation provided to the recipient.
However, Chambers teaches a method of taking measurements in a hearing prosthesis (Abstract) wherein a neural stimulating circuit is shut off during measurements in order to reduce noise during measurements (paragraph [0045]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Keller with the teachings of Chambers so that the one or more processors are configured to obtain cochlear biological state data of the recipient's cochlea while reducing vestibular stimulation; and obtain vestibular biological state data of the recipient's vestibular system while reducing cochlear stimulation, because doing so lowers noise and reduces interference while sensitive measurements are taken (Chambers, paragraphs [0045], [0047]), thus improving the accuracy of the measurements while minimizing the impact of these adjustments on the overall operation of the device (Chambers, paragraph [0036]).
Conclusion
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/CHRISTINE SISON/Examiner, Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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