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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 16, 2026 has been entered.
Response to Amendment
The amendment filed February 16, 2026 has been entered. Claims 1-4, 6, 8, 10-11, 16-17 and 22 have been amended. Claims 18-20 are canceled. Currently, claims 1-17 and 21-23 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 8-12, filed February 16, 2026, with respect to the rejection(s) of claim(s) 1-17 and 21-23 under 35 U.S.C. 102 or 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Saoji et al. (US 2016/0144177) and Kals (US 2012/0065705).
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 14-15 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 14 recites the limitation "the one or more electrodes" in lines 1, 2, 4, and 5. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is referencing the, plurality of electrodes of the electrode lead in claim 1, the plurality of returning electrodes of claim 8, or the extracochlear ground electrode and/or the intracochlear ground electrode of claim 9.
Claim 15 recites the limitation "the one or more electrodes" in lines 1-2 and 6. There is insufficient antecedent basis for this limitation in the claim. It is unclear if this is referencing the, plurality of electrodes of the electrode lead in claim 1, the plurality of returning electrodes of claim 8, or the extracochlear ground electrode and/or the intracochlear ground electrode of claim 9.
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.
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.
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.
Claim(s) 1-2, 4-5, 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saoji et al. (US 2016/0144177) in view of Carlyon et al. (US 2012/0130449) and Kals (US 2012/0065705).
Regarding claim 1, Saoji et al. discloses a medical device (fig. 1) configured for providing electrical stimulation auditory nerve fibers of a recipient of the medical device, wherein the medical device comprises: an interface 302 configured to provide audio stimulation information based on an external signal 102 ([0026]), an electrode lead 110 including a plurality of electrodes configured to provide electrical stimulation of the auditory nerve fibers based on the audio stimulation signal, a mode unit 304 configured to selectively connect one or more electrodes of the plurality of electrodes to at least one anodic current source or at least one cathodic current source (“cochlear implant 108 may include a plurality of independent current sources each associated with a channel defined by one or more of electrodes 112. In this manner, different stimulation current levels may be applied to multiple stimulation sites simultaneously by way of multiple electrodes 112.” [0022]), wherein the mode unit is configured to: selectively assign the one or more electrodes of the plurality of electrodes into a mode of a plurality of modes based on the audio stimulation information, and wherein the plurality of modes includes an active mode ([0027]), set a first electrode e2 of the plurality of electrodes into an active mode at a first time to receive a first anodic current (fig. 6, [0041]), wherein the first anodic current is generated based on the audio information ([0033]), and at a second time subsequent to the first time, set a second electrode e3 to an active mode ([0027]) to receive a first cathodic current (fig. 6).
Saoji et al. does not expressly disclose a differential power supplier including at least one anodic current source configured to provide an anodic current and at least one cathodic current source configured to provide a cathodic current. Carlyon et al. teaches a medical device configured for providing electrical stimulation to auditory nerve fibers of a cochlea of a recipient of the medical device, comprising a differential power supplier 826 ([0071]) including at least one anodic current source configured to provide an anodic current and at least one cathodic current source configured to provide a cathodic current ([0067-0069]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saoji et al. to include a differential power supplier to provide an anodic current and a cathodic current as taught by Carlyon et al. as it is a known feature in the art of cochlear implants for providing anodic and cathodic current sources, such a modification being reasonably predictable and would not alter the overall operation of the device.
Saoji et al. does not expressly disclose the first cathodic current corresponds to the first anodic current, wherein a level of the first cathodic current is determined based on a level of the first anodic current. Kals teaches taking into consideration the level of current generated from an electrode fitted at a first time to determine the level of current generated from an electrode at a subsequent time ([0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saoji et al. such that at a second time subsequent to the first time, the second electrode would receive a level of a first cathodic current determined based on a level of the first anodic current as taught by Kals in order to take into consideration current spread from the previous fitted electrode rather than starting from zero or any other arbitrarily estimated level ([0033]).
Regarding claim 2, Saoji et al. does not expressly disclose a phase state switch in the manner claimed. Carlyon et al. teaches wherein a phase state switch 828 is configured to receive the anodic current or the cathodic current from the differential power supplier 826 and forward the anodic current or the cathodic current to the first electrode or the second electrode based on a trigger signal to the mode unit ([0071]; fig. 8 discloses both 828 and 830 controlled by 826). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saoji et al. to include a phase state switch in the manner as taught by Carlyon et al. as it is a known feature in the art of cochlear implants for providing anodic and cathodic current sources, such a modification being reasonably predictable and would not alter the overall operation of the device.
Regarding claim 4, Saoji et al. in view of Carlyon et al. discloses wherein the anodic current source and the cathodic current source are connected to the phase state switch (fig. 8).
Regarding claim 5, Saoji et al. discloses wherein the audio stimulation information includes information about one or more electrical stimulation signals ([0018]), and wherein the information about the one or more electrical stimulation signals includes stimulation level, amplitude, phase, timing and/or frequency ([0027], [0038]).
Regarding claim 22, Saoji et al. discloses a method for providing electrical stimulation to a recipient of a medical device, comprising: obtaining audio stimulation information based on an external signal 102 ([0026]), providing, via a plurality of electrodes 110, electrical stimulation to the recipient based on the audio stimulation signal; assigning, via a mode unit 304, one or more electrodes of the plurality of electrodes into a mode of a plurality of modes based on the audio stimulation information (“cochlear implant 108 may include a plurality of independent current sources each associated with a channel defined by one or more of electrodes 112. In this manner, different stimulation current levels may be applied to multiple stimulation sites simultaneously by way of multiple electrodes 112.” [0022]), wherein the mode unit is configured to: selectively assign the one or more electrodes of the plurality of electrodes into a mode of a plurality of modes based on the audio stimulation information, and wherein the plurality of modes includes an active mode ([0027]), including: setting a first electrode e2 of the plurality of electrodes into an active mode at a first time to receive a first anodic current (fig. 6, [0041]), wherein the first anodic current is generated based on the audio information ([0033]), and at a second time subsequent to the first time, setting a second electrode e3 of the plurality of electrodes to an active mode ([0027]) to receive a first cathodic current (fig. 6).
Saoji et al. does not expressly disclose a differential power supplier including at least one anodic current source configured to provide an anodic current and at least one cathodic current source configured to provide a cathodic current. Carlyon et al. teaches a medical device configured for providing electrical stimulation to auditory nerve fibers of a cochlea of a recipient of the medical device, comprising a differential power supplier 826 ([0071]) including at least one anodic current source configured to provide an anodic current and at least one cathodic current source configured to provide a cathodic current ([0067-0069]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saoji et al. to include a differential power supplier to provide an anodic current and a cathodic current as taught by Carlyon et al. as it is a known feature in the art of cochlear implants for providing anodic and cathodic current sources, such a modification being reasonably predictable and would not alter the overall operation of the device.
Saoji et al. does not expressly disclose the first cathodic current corresponds to the first anodic current, wherein a level of the first cathodic current is determined based on a level of the first anodic current. Kals teaches taking into consideration the level of current generated from an electrode fitted at a first time to determine the level of current generated from an electrode at a subsequent time ([0033]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saoji et al. such that at a second time subsequent to the first time, the second electrode would receive a level of a first cathodic current determined based on a level of the first anodic current as taught by Kals in order to take into consideration current spread from the previous fitted electrode rather than starting from zero or any other arbitrarily estimated level ([0033]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saoji et al. (US 2016/0144177) in view of Carlyon et al. (US 2012/0130449) and Kals (US 2012/0065705) and further in view of Moffitt (US 8,180,445).
Regarding claim 3, Saoji et al. does not disclose the specifics of a clock unit configured to provide the trigger signal based on the audio stimulation information. Moffitt teaches it is known in the art to use timer logic circuitry 56 to provide a trigger signal output to a mode unit 68 connected to one or more electrodes E1-16 (fig. 5), the timer logic circuitry controlling parameters of a biphasic stimulation energy output based on stimulation information (col. 7, line 56 to col. 8, line 1). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saoji et al. to incorporate a clock unit such as the timer logic circuitry 56 as taught by Moffitt in order to help control the pulse rate, width, interphase parameters of the stimulation energy for the cochlear implant (col. 7, line 56 to col. 8, line 1).
Claim(s) 6-9, 12-13, 21, 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saoji et al. (US 2016/0144177) in view of Carlyon et al. (US 2012/0130449) and Kals (US 2012/0065705) and further in view of Dupeyron (US 2010/0069997).
Regarding claim 6, Saoji et al. does not expressly disclose a first ground mode unit connected to the mode unit, and the mode unit and the ground mode unit are configured to set the one or more electrodes to a ground mode of the plurality of modes by connecting the one or more electrodes to ground based on the audio stimulation information. Dupeyron teaches a first ground mode unit 13, 15 (fig. 5) for setting one or more electrodes to a ground mode (“remaining electrodes in the set of M electrodes are electrically connected to the electrical reference, then this mode of stimulation is referred to as "common ground."” [0031]), this mode also used to remove accumulated charges when necessary ([0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saoji et al. to include the first ground mode unit in order to safely allow for the one or more electrodes to be set to a common ground mode when not in active use ([0045]), such circuitry being known in the art for a similar device, and would yield predictable results without altering the overall operation of the device.
Regarding claim 7, Saoji et al. in view of Dupeyron et al. discloses the first ground mode unit includes a digital switch circuitry 15, 40, a ground and a first resistor 13, and wherein the digital switch circuitry is configured to connect the one or more electrodes to the ground either directly or via the first resistor based on the audio stimulation information ([0045]).
Regarding claim 8, Saoji et al. discloses a return electrode ([0039]) but does not expressly disclose a second ground mode unit configured to set a plurality of returning electrodes of the electrode lead into a ground mode by connecting the plurality of returning electrodes to ground either directly or indirectly via a second resistor based on the audio stimulation information. Dupeyron teaches a second ground mode unit 13, 15 (fig. 5) for connecting a plurality of electrodes to ground (“the remaining electrodes in the set of M electrodes are electrically connected to the electrical reference, then this mode of stimulation is referred to as "common ground."” [0031]) to remove accumulated charges when necessary via a resistor 13 (“selectively couple the electrode 12 to ground through a resistor 13” [0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saoji et al. to include the second ground mode unit in configured to set a the plurality of returning electrodes to ground either directly or indirectly via a second resistor based on the audio stimulation information as taught by Dupeyron order to safely allow for the one or more return electrodes to be set to a common ground mode when not in active use ([0045]), such circuitry being known in the art for a similar device, and would yield predictable results without altering the overall operation of the device.
Regarding claim 9, Saoji et al. in view of Carylon et al. disclose wherein the plurality of returning electrodes includes one or more extracochlear ground electrode arranged outside the cochlea and/or one or more intracochlear ground electrode arranged within the cochlea ([0005]).
Regarding claim 12, Saoji et al. teaches a signal processing unit 104 configured to receive audio stimulation information ([0024]), and Saoji et al. in view of Dupeyron disclose determining whether the connection to ground should be via the first resistor 13 based on if the one or more electrodes should be connected to ground based on the audio stimulation information ([0045]).
Regarding claim 13, Saoji et al. teaches a signal processing unit 104 configured to receive audio stimulation information ([0024]), and Saoji et al. in view of Dupeyron disclose determining whether the connection to ground should be via the second resistor 13 based on if the one or more return electrodes should be connected to ground based on the audio stimulation information ([0045]).
Regarding claim 21, Saoji et al. does not expressly disclose wherein the ground mode includes resistor-based current steering. Dupeyron teaches assigning one or more electrodes of a plurality of electrodes to a ground mode (“remaining electrodes in the set of M electrodes are electrically connected to the electrical reference, then this mode of stimulation is referred to as "common ground."” [0031]), the ground mode including a resistor-based current steering (“selectively couple the electrode 12 to ground through a resistor 13”) used to remove accumulated charges when necessary ([0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saoji et al. to include assigning one or more electrodes of the plurality of electrodes to a ground mode that includes resistor-based current steering as taught by Dupeyron in order to safely allow for the one or more electrodes to be set to a common ground mode when not in active use ([0045]), such circuitry being known in the art for a similar device, and would yield predictable results without altering the overall operation of the device.
Regarding claim 23, Saoji et al. does not expressly disclose wherein the ground mode includes resistor-based current steering. Dupeyron teaches assigning one or more electrodes of a plurality of electrodes to a ground mode (“remaining electrodes in the set of M electrodes are electrically connected to the electrical reference, then this mode of stimulation is referred to as "common ground."” [0031]), the ground mode including a resistor-based current steering (“selectively couple the electrode 12 to ground through a resistor 13”) used to remove accumulated charges when necessary ([0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saoji et al. to include assigning one or more electrodes of the plurality of electrodes to a ground mode that includes resistor-based current steering as taught by Dupeyron in order to safely allow for the one or more electrodes to be set to a common ground mode when not in active use ([0045]), such circuitry being known in the art for a similar device, and would yield predictable results without altering the overall operation of the device.
Claim(s) 10 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saoji et al. (US 2016/0144177) in view of Carlyon et al. (US 2012/0130449) and Kals (US 2012/0065705) and further in view of Vaiarello et al. (US 2020/0030611).
Regarding claim 10, Saoji et al. does not expressly disclose wherein the plurality of modes includes a high impedance mode, and the mode unit is configured to set the one or more electrodes to the high impedance mode by connecting the one or more electrodes to an impedance which is higher than the active mode and the ground mode. Vaiarello et al. teaches that a high impedance mode for a stimulation unit is known in the art ([0017]), for providing a safety mode when a particular electrode is not used for stimulation ([0081], [0089]) where the high impedance mode disconnects the electrode from a stimulation current source ([0063]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saoji et al. to include a high impedance mode as the plurality of modes, wherein the mode unit is configured to set the one or more electrodes to the high impedance mode by connecting the one or more electrodes to a high impedance as taught by Vaiarello et al. in order to provide a safety mode when a particular electrode is not used for stimulation ([0081], [0089]), such a modification known in the art, and the results of such a modification being reasonably predictable.
Regarding claim 16, Saoji et al. discloses wherein the one or more electrodes in active mode receive the anodic current or the cathodic current within a first time period ([0040]), and the one or more electrodes in active mode is grounded in a second time period (fig. 6; electrodes that are off are grounded), and within the second time period an electrode of the plurality of electrodes not being in the active mode during the first time period is configured to receive a current opposite in phase of the current applied to the one or more electrode in the active mode in the first time period, and wherein the first time period is before the second time period (fig. 6). Saoji et al. does not expressly disclose that within the first time period one or more other electrodes of the plurality of electrodes are in high impedance mode.
Vaiarello et al. teaches that a high impedance mode for a stimulation unit is known in the art ([0017]), for providing a safety mode when a particular electrode is not used for stimulation ([0081], [0089]) where the high impedance mode disconnects the electrode from a stimulation current source ([0063]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saoji et al. to set the one or more other electrodes that are inactive to the high impedance mode as taught by Vaiarello et al. in order to provide a safety mode when a particular electrode is not used for stimulation ([0081], [0089]), such a modification known in the art, and the results of such a modification being reasonably predictable.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saoji et al. (US 2016/0144177) in view of Carlyon et al. (US 2012/0130449), Kals (US 2012/0065705) and Dupeyron (US 2010/0069997) and further and in further view of Vaiarello et al. (US 2020/0030611).
Regarding claim 11, Saoji et al. in view of Dupeyron does not expressly disclose wherein the second ground mode unit is configured to set the plurality of returning electrodes of the electrode lead to the high impedance mode, and where the high impedance mode includes an impedance which is higher than in the ground mode. Vaiarello et al. teaches that a high impedance mode for a stimulation unit is known in the art ([0017]), for providing a safety mode when a particular electrode is not used for stimulation ([0081], [0089]) where the high impedance mode disconnects the electrode from a stimulation current source ([0063]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saoji et al. to include a high impedance mode as the plurality of modes, wherein the second ground mode unit is configured to set the one or more return electrodes to the high impedance mode by connecting the one or more electrodes to a high impedance as taught by Vaiarello et al. in order to provide a safety mode when a particular electrode is not used for stimulation ([0081], [0089]), such a modification known in the art, and the results of such a modification being reasonably predictable.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saoji et al. (US 2016/0144177) in view of Carlyon et al. (US 2012/0130449), Kals (US 2012/0065705) and Dupeyron (US 2010/0069997) and further and in further view of Koka et al. (US 2020/0171301).
Regarding claim 14, Saoji et al. discloses wherein the one or more electrodes is in the active mode ([0040]), one or more other electrodes of the plurality of electrodes are in ground mode (fig. 6, inactive electrodes are in ground mode). Saoji et al. in view of Carlyon et al. disclose an extracochlear electrode ([0005]) but does not expressly disclose the extracochlear electrode is connected to ground via a second resistor. Koka et al. teaches providing an extracochlear electrode 601-G connected to ground 710 via a resistor ([0063]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Saoji et al. to provide a resistor between the extracochlear electrode and ground as taught by Koka et al. as such a known relationship exists, the results of such a modification being reasonably predictable. Koka et al. teaches such a structural relationship provides a voltage between stimulating electrodes and the extracochlear ground electrode ([0063]) thus meeting the claimed language that the one or more other electrodes (112 rejection above) receives more return current from the stimulation provided by the one or more electrodes (112 rejection above) than the one or more extracochlear ground electrode).
Allowable Subject Matter
Claim 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 17 is directed to a particular electrical stimulation relationship between the plurality of electrodes on the lead of a cochlear stimulation medical device, intracochlear grounded electrodes, extracochlear ground electrodes and the return current received by the intracochlear grounded electrodes and the extracochlear ground electrodes from a third electrode of the plurality of electrodes on the lead. The prior art does not teach the specific relationship required by this claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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