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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-4 and 6-8 in the reply filed on 10 February 2026 is acknowledged. The traversal is on the ground(s) that the restriction is procedurally defective, and thus violates the Administrative Procedures Act (APA). This is not found persuasive because “Where a group of invention is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art” (view pg. 2 of Restriction Requirement mailed 10 December 2025). Thus, the argument “the default is presumption of unity of invention” is not persuasive as the requirement of unity of invention is ONLY fulfilled only when above emphasized conditions are met.
Additionally, applicant argues that Art Unit 3792 ignores half the claim language of claims 1 and 11 (view pg. 4-5 of Remarks), however, Examiner notes that “at least one implantable electrode” is a technical feature that is recited in all three groups (claims 1, 11, and 38) the feature of “obtaining data indicative of wear of the at least one electrode”, although shared between 1 and 11 is not explicitly shared with claim 38. Thus, the only shared technical feature between the groups is “at least one implantable electrode” which is not a special technical feature over Crosby.
Without acquiescing to Applicant’s arguments, Examiner also notes that if the shared technical feature is in fact obtaining data indicative of wear of the at least one implantable electrode, this is not a special technical feature as it does not make a contribution over the prior art in view of Mauch et al. (US 2012/0300953 A1), hereinafter Mauch.
Mauch discloses obtaining data indicative of wear of the at least one implantable electrode (Fig. 2: Step 242, [0027] “The method begins at step 242 where bipolar impedance values are obtained from the electrodes of cochlear implant electrode array. As shown, step 242 includes two actions, including measuring the impedance between each of the electrodes, and then performing a common ground measurement”, [0028] “comparison of one electrode's impedance or voltage values to the average values for all other electrodes may provide an indication of an issue”, [0062] “the detection of shunt impedances, perilymph impedances and the changes of these impedances over time by evaluator 130 allows automatic detection and reporting of actual or potential fault conditions in the electrode array of the implantable hearing device”, [0068], [0072]).
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-12, 14-17, 19, and 38-43 withdrawn from further consideration pursuant to 37 CFR 1.142 (b), as being drawn to nonelected apparatus, there being no allowable generic or linking claim.
Examiner will consider rejoinder of non-elected claims if and when allowable subject matter has been indicated.
Response to Amendments
This Office Action is responsive to the amendment filed on 10 February 2026. As per the amendment: claims 11-12, 14-17, 19, and 38-43 withdrawn, claims 3-4, 6-8, 19, and 41-43 have been previously amended, claims 5, 9-10, 13, 18, 20-37, and 44-47 remain cancelled, and no new claims have been added. Thus, claims 1-4 and 6-8 are presently pending and under examination.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 09/15/2023 and 02/14/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-4 and 6-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mauch et al. (US 2012/0300953 A1), hereinafter Mauch.
Regarding claim 1, Mauch discloses a medical device (cochlear implant 100), comprising:
an implantable portion of the medical device (electrode array 122), the implantable portion including at least one electrode ([0024] “Electrode array 122 may comprises one or more reference electrodes, extra-cochlea electrodes, or electrodes implanted in the recipient's cochlear.”)
the implantable portion is configured to, while implanted in a human, obtain indicative of wear of the at least one electrode (Fig. 2: Step 242, [0027] “The method begins at step 242 where bipolar impedance values are obtained from the electrodes of cochlear implant electrode array. As shown, step 242 includes two actions, including measuring the impedance between each of the electrodes, and then performing a common ground measurement”, [0028] “comparison of one electrode's impedance or voltage values to the average values for all other electrodes may provide an indication of an issue”, [0062] “the detection of shunt impedances, perilymph impedances and the changes of these impedances over time by evaluator 130 allows automatic detection and reporting of actual or potential fault conditions in the electrode array of the implantable hearing device”, [0068], [0072]).
Regarding claim 2, Mauch discloses the medical device of claim 1 (as shown above), wherein:
the implantable portion is configured to communicate the obtained data and/or data based on the obtained data transcutaneously to a device located outside the human ([0022] “Cochlear implant 100 further comprises an external component 104. External component 104 includes a transceiver 124 that transfers power and/or data to transceiver 106 via an inductive radio frequency (RF) link 134, a microphone 126, pre-processing unit 128, and a battery 132. External component 104 also includes an evaluator 130 that, along with measurement unit 109, form an integrity system.”, [0026] “In embodiments of the present invention, a test is initiated by evaluator 130 via communication link 134, and is performed by measurement unit 109. The results of the measurement are then sent back to evaluator 130 via communication link 134. Evaluator 130 processes the results of the tests and may then perform one or more diagnostic operations based thereon.”, Figure 1)
Regarding claim 3, Mauch discloses the medical device of claim 1 (as shown above), wherein: the medical device is configured to analyze the obtained data and determine a wear status of the at least one electrode and communicate an indication of the wear status ([0025] “cochlear implant 100 includes an integrity system comprising measurement unit 109 and evaluator 130. The integrity system is configured to perform a number of tests to evaluate the operation of cochlear implant 100.”, [0018] “The integrity system uses one or more of a number of different measurements to evaluate whether the prosthesis is operating as desired. In particular, the voltage of the power supply, the electrode voltage and/or the electrode impedance, is measured and used to evaluate the operational performance”, view Figure 2, [0028]-[0029] “Next, at step 246, the normalized impedance matrix is compared with expected values to determine whether the integrity of the device is as expected, that is, whether an issue has been detected…If an issue is detected, a diagnostic operations 250 is performed. The type of diagnostic operation 250 provided may depend on different factors, such as what issue is detected. As noted above, one output is to alert the recipient that the integrity system has detected an issue.”, [0066]).
Regarding claim 4, Mauch discloses the medical device of claim 1 (as shown above), wherein:
the medical device is configured to enable an adjustment of an operation of the cochlear implant to reduce future wear rate of the at least one electrode and/or one or more other electrodes of the implantable component ([0029] “The type of diagnostic operation 250 provided may depend on different factors, such as what issue is detected. As noted above, one output is to alert the recipient that the integrity system has detected an issue. Alternatively or additionally, other diagnostic operations include alerting a health care provider or storing an alert for an appropriate time, such as at the next visit to the health care provider. Additionally, the diagnostic operation may include taking corrective action to alter settings of the cochlear implant so as to attempt to remedy the issue.”, [0066] “For example, an escalation algorithm for an implantable hearing device is implemented as follows: (1) receive error indication that operation is not as desired, (2) determine appropriate adjustments based on the error indication, (3) determine whether adjustments to be made require recipient and/or health care provider approval, (4) if recipient and/or health care provider approval required: alert recipient to error condition, (5) if recipient and/or health care provider approval not required: make self-correcting adjustments, (6) alert recipient to action taken due to error condition.”, [0067] “Depending on the severity of the error condition, integrity system may temporarily deactivate an electrode or make other setting changes pending confirmation from the recipient of healthcare professional that an improvement in hearing due to the changes has occurred.”, [0068] and [0070], Figure 7).
Regarding claim 6, Mauch discloses the medical device of claim 1 (as shown above), wherein: the medical device is configured to analyze the obtained data and determine a wear status of the at least one electrode and automatically adjust an operation of the cochlear implant to compensate for the wear of the at least one electrode ([0029] “The type of diagnostic operation 250 provided may depend on different factors, such as what issue is detected. As noted above, one output is to alert the recipient that the integrity system has detected an issue. Alternatively or additionally, other diagnostic operations include alerting a health care provider or storing an alert for an appropriate time, such as at the next visit to the health care provider. Additionally, the diagnostic operation may include taking corrective action to alter settings of the cochlear implant so as to attempt to remedy the issue.”, [0066] “For example, an escalation algorithm for an implantable hearing device is implemented as follows: (1) receive error indication that operation is not as desired, (2) determine appropriate adjustments based on the error indication, (3) determine whether adjustments to be made require recipient and/or health care provider approval, (4) if recipient and/or health care provider approval required: alert recipient to error condition, (5) if recipient and/or health care provider approval not required: make self-correcting adjustments, (6) alert recipient to action taken due to error condition.”, [0065] “A further improvement is the automatic modification of the operation of cochlear implant 100. For example, if a shunt, open circuit or short circuit occurs at a particular electrode due to, for example, a deterioration of the insulation around the electrode, these deviations from expectations can be used to automatically deactivate affected electrodes. For example, if the normalized impedance matrix has values outside tolerances, then the integrity system may alter which electrodes are to be used, deactivating electrodes, if required.”).
Regarding claim 7, Mauch discloses the medical device of claim 1 (as shown above), wherein: the medical device is a cochlear implant ([0006] “In one aspect of the present invention, an implantable hearing prosthesis is provided”, cochlear implant 100).
Regarding claim 8, Mauch discloses the medical device of claim 1 (as shown above), wherein: the medical device is configured to analyze the obtained data and determine a wear status of the at least one electrode and automatically recommend an adjustment operation of the cochlear implant to compensate for the wear of the at least one electrode ([0029] “The type of diagnostic operation 250 provided may depend on different factors, such as what issue is detected. As noted above, one output is to alert the recipient that the integrity system has detected an issue. Alternatively or additionally, other diagnostic operations include alerting a health care provider or storing an alert for an appropriate time, such as at the next visit to the health care provider. Additionally, the diagnostic operation may include taking corrective action to alter settings of the cochlear implant so as to attempt to remedy the issue.”, [0065] “A further improvement is the automatic modification of the operation of cochlear implant 100. For example, if a shunt, open circuit or short circuit occurs at a particular electrode due to, for example, a deterioration of the insulation around the electrode, these deviations from expectations can be used to automatically deactivate affected electrodes. For example, if the normalized impedance matrix has values outside tolerances, then the integrity system may alter which electrodes are to be used, deactivating electrodes, if required.”, [0068] “If the integrity system deactivates electrodes after an analysis has been performed, the operation of the implant may be altered based on the new configuration. For example, the sound spectrum would be redistributed to the unaffected electrodes. As such, this is another form of corrective diagnostic operations that adjust the functionality of the implant to compensate for defective electrodes caused by current shunts, open and short circuit electrodes.”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cornejo et al. (US Patent 8,065,017 B2) discloses a standard Cochlear Stimulation System 114) capable of reporting non-functional intracochlear electrodes (Column 9, lines 44-52)
Tsampazis et al. (US 2015/0360028 A1) discloses diagnostic and adaptive circuitry is configured to execute testing and adaptive (corrective) functions of an implantable medical system (Abstract)
Shepherd, Robert K., et al. "Chronic intracochlear electrical stimulation at high charge densities results in platinum dissolution but not neural loss or functional changes in vivo." Journal of neural engineering 16.2 (2019): 026009. Teaches platinum corrosion used for electrical stimulation application
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ATTIYA SAYYADA HUSSAINI whose telephone number is (703)756-5921. The examiner can normally be reached Monday-Friday 8:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached at 5712724156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ATTIYA SAYYADA HUSSAINI/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights