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 without traverse of Group I in the reply filed on February 19, 2026 is acknowledged. Applicant has additionally amended the claims in Groups II and III to be dependent on claim 1. The restriction requirement as set forth in the Office action mailed on December 23, 2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01. Applicant has also added new claims 21-23 and has erroneously indicated them as provisionally withdrawn. Claims 21-23 were not subject to a restriction requirement and should be indicated with the status identifier of “New”.
Response to Amendment
The amendment filed February 19, 2026 has been entered. Claims 9-10, 15, 19-20 are amended. Claims 8, 13-14 are canceled. Claims 21-23 are new. Currently, claims 1-7, 9-12, 15-23 are pending for examination.
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 1-7, 9-12, 15-23 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.
Claim 1 requires the step of (1) “determining, from the intra-operative acoustically-evoked inner ear potentials, a tonotopic frequency of the cochlea at a position of the at least one stimulating electrode within the cochlea” and further recites the step of, (2) “aligning the stimulating assembly with a tonotopy of the cochlea by matching a frequency associated with the at least one stimulating electrode to the tonotopic frequency of the cochlea at the position of the at least one stimulating electrode within the cochlea”. A review of the specification indicates that steps (1) and (2) are best supported by paragraph [0077] of the published application. Instead of “a tonotopic frequency of the cochlea” being determined from the acoustically-evoked inner ear potentials, the disclosure states the reverse- that a frequency is first selected as an acoustic input to obtain ECochG (“acoustically-evoked potentials/responses (e.g., electrocochleography) [0063]) measurements. Therefore, frequencies are not determined by the acoustically-evoked inner ear potentials, as currently recited by the claim. Claim 1 lacks support because the wording of step (1) suggests a tonotopic frequency of the cochlea at a position of the at least one stimulating electrode within the cochlea is determined from intra-operative acoustically-evoked inner ear potentials, but specification does not appear to support this interpretation. Step (2) builds on this determined tonotopic frequency from the intra-operative acoustically-evoked inner ear potentials. In step (2), the frequency associated with the at least one stimulation electrode is matched to the tonotopic frequency determined in step (1), and therefore is also not disclosed by the specification. Issues of adequate written description may arise even for original claims, for example, when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the inventor had possession of the claimed invention at the time of filing. See MPEP 2163(I)(A).
Claims 2-7, 9-12, 15-20 are rejected to for being dependent on an for failing to remedy the deficiencies of claim 1.
Claim 21 substantially recites the same limitations as claim 1 and is therefore rejected to for the same reasons as claim 1 above.
Claims 22-23 are rejected to for being dependent on an for failing to remedy the deficiencies of claim 21.
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 4, 6-7, 9-12, 17 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 4 recites the limitation "matching the frequency associated with a plurality of stimulation electrodes" in line 2. There is insufficient antecedent basis for this limitation in the claim. A frequency associated with a plurality of stimulating electrodes has not been previously recited.
Claim 4 recites the limitation "the tonotopic frequency of the cochlea at the position of the plurality of stimulating electrodes" in line 3-4. There is insufficient antecedent basis for this limitation in the claim. The tonotopic frequency at the position of a plurality of stimulating electrodes has not been previously recited.
Claim 6 recites the limitation "controlling insertion of the stimulating assembly " in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite a step of “inserting the stimulating assembly” to allow for claim 6 to reference, “controlling insertion of the stimulating assembly”.
Claim 7 recites “wherein controlling insertion of the stimulating assembly” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite a step of “inserting the stimulating assembly” to allow for claim 7 to reference, “controlling insertion of the stimulating assembly”.
Claim 9 recites the limitation "during insertion of the stimulating assembly into the cochlea of the recipient" in lines 2 and 5. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite a step of “inserting the stimulating assembly” to allow for claim 9 to use the phrase, “during insertion of the stimulating assembly”.
Claim 11 recites the limitation, “stop insertion of the stimulating assembly” in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite a step of “inserting the stimulating assembly” to allow for claim 11 to use the phrase, “stop insertion of the stimulating assembly”.
Claim 12 recites the limitation “stopping automated insertion of the stimulating assembly” in line 2 and “for a surgeon to stop insertion of the stimulating assembly” in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite a step of “inserting the stimulating assembly” to allow for claim 12 to use the phrase, “stopping automated insertion” and “surgeon to stop insertion”.
Claims 10-12 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 9.
Claim 17 recites the limitation “stopping automated insertion of the stimulating assembly” in line 2 and “for a surgeon to stop insertion of the stimulating assembly” in line 3. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite a step of “inserting the stimulating assembly” to allow for claim 17 to use the phrase, “stopping automated insertion” and “surgeon to stop insertion”.
Statement Regarding Prior Art
Koka et al. (US 2019/0030323) discloses a method, comprising: obtaining intra-operative acoustically-evoked inner ear potentials from a cochlea of a recipient of a cochlear implant (“During insertion procedure 1000, monitoring system 600 may monitor evoked responses that occur within cochlea 802 in response to the acoustic stimulation produced at the particular frequency” [0072]), wherein the intra-operative acoustically-evoked inner ear potentials are obtained via at least one stimulating electrode of a stimulating assembly of the cochlear implant (“the monitoring of the evoked responses may be performed using an intracochlear electrode included in a plurality of intracochlear electrodes disposed on a distal portion of the lead” [0042]; “monitoring system 600 may use intracochlear electrode 112-1 to measure a first evoked response at a first insertion depth 1004-1 and a second evoked response at a second insertion depth 1004-2.” [0072]). However, Koka et al. does not disclose the steps of “determining, from the intra-operative acoustically-evoked inner ear potentials, a tonotopic frequency of the cochlea at a position of the at least one stimulating electrode within the cochlea; and aligning the stimulating assembly with a tonotopy of the cochlea by matching a frequency associated with the at least one stimulating electrode to the tonotopic frequency of the cochlea at the position of the at least one stimulating electrode within the cochlea”.
Both Buchman et al. (US 2014/0094712) and Bouchataoui et al. (US 2013/0006328) disclose a method, comprising: obtaining intra-operative acoustically-evoked inner ear potentials from a cochlea of a recipient of a cochlear implant, wherein the intra-operative acoustically-evoked inner ear potentials are obtained via at least one stimulating electrode of a stimulating assembly of the cochlear implant. However, neither references disclose the steps of “determining, from the intra-operative acoustically-evoked inner ear potentials, a tonotopic frequency of the cochlea at a position of the at least one stimulating electrode within the cochlea; and aligning the stimulating assembly with a tonotopy of the cochlea by matching a frequency associated with the at least one stimulating electrode to the tonotopic frequency of the cochlea at the position of the at least one stimulating electrode within the cochlea”.
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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