DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed April 23, 2026 has been entered. Claims 21, 28, 31, 38 have been amended. Claims 1-20 were previously canceled. Currently, claims 21-40 are pending for examination.
Response to Arguments
Applicant's arguments filed April 23, 2026 have been fully considered but they are not persuasive. Applicant argues on pages 6-8 that Karunasiri (US 2016/0235984) does not expressly disclose the limitation, generating “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” as required by the claim. The applicant acknowledges the prior art disclosing that subsequent to an electrical stimulation pulse being applied by way of the electrode, an additional stimulation pulse representative of an audio signal may be generated and applied by way of the electrode ([0041]) and that a change in impedance that occurs during a time period between when the electrical stimulation pulse and the additional electrical stimulation pulse is determined (p. 8). Karunasiri also discloses, “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. The electrical stimulation parameters may control various parameters of the stimulation current applied to a stimulation site including, but not limited to, frequency, pulse width… For example, if an increase in impedance for the electrode is detected, stimulation management facility 302 may be configured to adjust one or more stimulation parameters such that the total electric charge applied via the electrode remains constant. These changes may be made in real time and during the normal operation of the cochlear implant system 100 in order to attempt to maintain a consistent loudness level as perceived by the patient.” ([0042]). Karunasiri additionally states, “values corresponding to a current amplitude versus pulse width curve may be stored in a look up table and used to determine an appropriate pulse width for a particular current amplitude caused by a change in impedance…if an increase in impedance for a particular the electrode is detected, stimulation management facility 302 may be configured to adjust one or more stimulation parameters such that the total electric charge of electrical stimulation current applied via the electrode remains constant” ([0044]).
As an example, Karunasiri describes in paragraph [0043] a known system scenario where following a stimulation pulse applied to the electrode, determining the impedance of the electrode has doubled, therefore reducing the amplitude of the current applied to the electrode by one half for future electrical stimulation pulses. Following what is disclosed in paragraph [0044], a different pulse width would apply for future electrical stimulation pulses as compared to the pulse width of the initial stimulation pulse. This different pulse width would be provided “such that the total electric charge of electrical stimulation current applied via the electrode remains constant” ([0044]) and “in order to attempt to maintain a consistent loudness level as perceived by the patient.” ([0042]).
Though the term “pulse duration” is not used by Karunasiri, the terms “pulse width” of the electrical stimulation pulse and the additional electrical stimulation pulse described in the prior art is regarded as equivalent to applicant’s pulse duration for the first electrical pulse and the second electrical pulse. The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).
Applicant presents arguments (p. 7) stating the prior art does not disclose the first voltage is measured based on the first electrical pulse of the first pulse duration and the second voltage is measured base on the second electrical pulse of the second pulse duration. These bolded limitations are being treated as references to the durations of the respective electrical pulses and do not further limit the measurement of voltages of the electrical pulses. In other words, the different pulse durations of each of the first or second electrical pulses does not change how the first or second voltages are measured, respectively. This interpretation is supported by the applicant’s own specification as several instances state the measuring of a first voltage based on the first electrical pulse and a second voltage based on the second electrical pulse ([0011], [0034], [0080], [0095], [0104]) without factoring the durations of the pulses.
Applicant’s arguments, see page 6, filed April 23, 2026, with respect to the 35 U.S.C. 112(a) rejections have been fully considered and are persuasive. The rejections of claims 21-40 under 35 U.S.C. 112(a) have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 28 and 38 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. With the amendments to independent claims 21 and 31, respectively, the limitations recited in dependent claims 28 and 38 now fail to further limit the subject matter of the independent claims. Claim 28 recites, “wherein the pulse generating unit is further configured to select the first pulse duration of the first electrical pulse and the second pulse duration of the second electrical pulse”. However claim 21 recites, “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”. One of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious that a pulse generating unit that generates a first electrical pulse of a first pulse duration and a second electrical pulse of a second pulse duration would necessarily require selecting the first pulse duration and the second pulse duration of the first electrical pulse and the second electrical pulse, respectively. Therefore claim 28 fails to further limit claim 21. For these same reasons, claim 38 is also rejected to for failing to further limit claim 31. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 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 (“a stimulation pulse representing an audio signal may applied to the electrode. After processing the impedance detected by impedance management facility 304, stimulation management facility 302 may determine that the impedance of the electrode has doubled. This change in impedance may result in stimulation management facility 302 reducing the amplitude of the current to be applied to the electrode by one half for future electrical stimulation pulses to compensate for the change in impedance.” [0043]; “values corresponding to a current amplitude versus pulse width curve may be stored in a look up table and used to determine an appropriate pulse width for a particular current amplitude caused by a change in impedance…if an increase in impedance for a particular the electrode is detected, stimulation management facility 302 may be configured to adjust one or more stimulation parameters such that the total electric charge of electrical stimulation current applied via the electrode remains constant” [0044]) 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 of the first pulse duration and a second electrode based on the second electrical pulse of the second pulse duration (“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 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 the first duration of the first electrical pulse and the second duration of the second electrical pulse ([0022], [0041-0042], [0044]).
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 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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