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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 23, 2025 has been entered.
Response to Amendment
The amendment filed October 23, 2025 has been entered. Claims 21 and 31 have been amended. Claims 1-20 were previously canceled. Currently, claims 21-40 are pending for examination.
Response to Arguments
Applicant’s arguments, see pages 6-9, filed October 23, 2025, with respect to the rejection(s) of claim(s) 21-40 under 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 Therefore, the rejection has been withdrawn.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 Mishra (US 2016/0235985).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-40 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 21 and 31 have been amended to recite, “generating, by a pulse generating unit, a first electrical pulse and a second electrical pulse with one or more attributes different from at least one attribute of the first electrical pulse”. A claim may lack written description support when a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). Here, a broad genus claim (“one or more attributes different from at least one attribute” is presented when the disclosure only describes a narrow species (“a second pulse duration different from the first pulse duration based on the coded audio signal”) without evidence that the genus is contemplated. Paragraphs [0011], [0034], [0075], [0080], [0104] and the abstract of the published application are directed to the narrow species and do not recite the broad genus of the amended claim.
Claims 22-30 and 32-40 are rejected to for being dependent on claims 21 and 31.
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) 21-25, 27-35, 37-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karunasiri (US 2016/0235984) in view of Mishra (US 2016/0235985) and Kroll et al. (US 7,158,825).
Regarding claims 21, 31, Karunasiri discloses a system and method comprising: a pulse generating unit configured to generate a first electrical pulse of a first pulse duration and a second electrical pulse of a second pulse duration different from the first pulse duration based on the coded audio signal (“Cochlear implant 108 may be further configured to apply the electrical stimulation” [0022], “electrical stimulation pulse and the additional electrical stimulation pulse” [0041]); an electrode configured to receive at least the first electrical pulse and the second electrical pulse (“apply the electrical stimulation to one or more stimulation sites within the patient via one or more electrodes 112 disposed along lead 110” [0022]); a capacitor 410 connected to the electrode; a measurement unit 304 configured to measure, across a connection of the electrode and the capacitor, a first voltage based on the first electrical pulse and a second electrode based on the second electrical pulse (“measure a voltage level associated with the electrode while the electrical stimulation pulse is being applied by way of the electrode” [0033]; “measure an additional voltage level associated with the electrode while the additional electrical stimulation pulse is being applied by way of the electrode” [0041]).
Karunasiri does not expressly disclose the second electrical pulse with one or more attributes different from at least one attribute of the first electrical pulse. Mishra teaches an analogous system where a first electrical pulse and second electrical pulse are similarly delivered to the patient based on an audio signal, but further teaches a sound processor that determines if the amplitude of the first electrical pulse corresponding to a loudness level of the audio signal is less than or equal to a maximum stimulation pulse amplitude allowed by a compliance voltage before generating and applying the pulse to the patient according to a pulse amplitude modulation encoding scheme, and the sound processor further determines if the amplitude of the second electrical pulse corresponding to a second loudness level is greater than the maximum stimulation pulse amplitude allowed by the compliance voltage and to represent the second loudness level to the patient by generating and applying the pulse to the patient according to an encoding scheme that is different than the pulse amplitude modulation encoding scheme ([0015-0018]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Karunasiri to provide a sound processor to compare the amplitudes of the first and second electrical pulses against a maximum stimulation pulse amplitude allowed by a compliance voltage and to generate and apply the first and second electrical pulses according to different encoding schemes such as a pulse amplitude modulation encoding scheme as compared to a pulse density modulation encoding scheme or an encoding scheme that includes both pulse amplitude modulation and pulse width modulation to create one or more attributes in the second electrical pulse different from at least one attribute of the first electrical pulse as taught by Mishra in order to “accommodate varying loudness levels of an audio signal being presented to a cochlear implant patient”, thereby minimizing the compliance voltages as compared to a system that would be required if only one modulation scheme is utilized to encode loudness, and “facilitate increased battery life, improved performance, and/or other benefits compared to conventional loudness encoding schemes” ([0013]).
Karunasiri discloses an evaluation unit 302 configured to calculate an impedance difference derived from the measured first and second voltages (“change in impedance” [0041]) but does not expressly disclose calculating a voltage difference between the measured first and second voltages, and assess a status of the capacitor based on the voltage difference. Kroll et al. teaches it is known in the art for implantable medical devices to derive a voltage difference between two paths and analyzing the voltage to determine the capacitance value of a capacitor (“detects the current leakage from a leaky component”), and detect a leaky capacitor within the system (col. 10, lines 34-43). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Karunasiri to implement a leakage detection system within the evaluation unit and to take the already determined first and second voltages and calculate a voltage difference to derive capacitance information to determine the status of the capacitor as taught by Kroll et al. in order to prevent or at least minimize unwanted current leakage of the implantable system (col. 9, lines 22-27), such a modification would not alter the operation of the device and such a modification would have been reasonably predictable.
Regarding claims 22, 32, Karunasiri discloses the system includes an external unit 104 and an implantable unit 108 ([0018-0019]).
Regarding claims 23, 33, Karunasiri discloses the system is an implantable unit 108 ([0018-0019]).
Regarding claims 24, 34, Karunasiri does not expressly disclose wherein the evaluation unit is further configured to derive a capacitance value of the capacitor based on the voltage difference, wherein the capacitance value indicates a type of failure of the capacitor. Kroll et al. teaches it is known in the art to determine a leaky capacitor from voltage differences between current paths (col. 10, lines 34-43). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Karunasiri to determine a leaky capacitor based on a voltage difference between current paths as taught by Kroll et al. as it is a known method of determining failure in components, and such a modification would not alter the operation of the device and such a modification would have been reasonably predictable.
Regarding claims 25, 35, Karunasiri in view of Kroll et al. discloses the at least one type of failure referring to the capacitor is indicative of a leaky capacitor, if the derived capacitance value exceeds a predetermined threshold (col. 11, lines 43-52).
Regarding claims 27, 37, Karunasiri does not expressly disclose wherein the pulse generating unit is further configured to generate the first electrical pulse and the second electrical pulse for a plurality of current intensities, the measurement unit is further configured to measure the first voltage and the second voltage for each current intensity of the plurality of current intensities, and the evaluation unit is further configured to calculate the voltage difference for each current intensity. However, Karunasiri does teach the system and method of adjusting one or more stimulation parameters based on the determined difference between an updated impedance and a previously determined impedance of the electrode ([0042]), for example reducing the amplitude (intensity) of the current to be applied to the electrode for future stimulation pulses to compensate for particular changes in impedances ([0043]). Karunasiri also states measuring the impedance of the electrode “at different times to determine whether the impedance of the electrode has changed over a period of time” ([0040]), in the same manner as explained above for claim 21, where the pulse generating unit is further configured to generate the first electrical pulse and the second electrical pulse, the measurement unit is further configured to measure the first voltage and the second voltage, and the evaluation unit is further configured to calculate the voltage difference. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention that Karunasiri would perform the same steps of generating the first electrical pulse and the second electrical pulse for the new reduced current, measuring the first voltage and the second voltage for the new reduced current, and calculating the voltage difference of the new reduced current- provided that Karunasiri has disclosed continually monitoring and measuring the impedance of the electrode over a period of time, and an a change in current intensity resulting from a previously determined impedance change would not alter the overall operation of the system and method described in claim 21.
Regarding claims 28, 38, Karunasiri discloses wherein the pulse generating unit is further configured to select a first duration of the first electrical pulse and a second duration of the second electrical pulse, wherein the first duration of the first electrical pulse is different from the second duration of the second electrical pulse based on a coded audio signal ([0022], [0041]).
Regarding claims 29, 39, Karunasiri discloses the system is a cochlear implant system ([0016]).
Regarding claims 30, 40, Karunasiri discloses the evaluation unit is further configured to: derive a voltage relation over time (“variations in electrode impedance may occur at different times during a day”) based on a duration of a third electrical pulse (“Multiple updated impedances of the electrode may be measured as described herein to continually adjust/optimize electrical stimulation parameters associated with the electrode on-the-fly.” [0042]) and a voltage measured based on the electrical pulse ([0030]); and derive at least one type of voltage relation failure of at least one of the electrode, the capacitor, and the connection of the electrode and the capacitor based on the derived voltage relation (“electrode malfunction” [0030]).
Claim(s) 26, 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karunasiri (US 2016/0235984) in view of Mishra (US 2016/0235985) and Kroll et al. (US 7,158,825) and further in view of Heathershaw et al. (US 2003/0204225).
Regarding claims 26, 36, Karunasiri does not expressly disclose at least one type of failure is indicative of a shorted capacitor, if the calculated voltage difference is zero. Heathershaw et al. teaches it is known in the art for an associated voltage across a capacitor to be zero if the capacitor is shorted ([0074]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Karunasiri to determine a shorted capacitor based on a voltage difference being zero as taught by Heathershaw et al. as it is a known method of determining failure in components, and such a modification would not alter the operation of the device and such a modification would have been reasonably predictable.
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