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 the species represented by claims 1, 2, 4, 6, 7, 9, 13-18 and 20 in the reply filed on May 29, 2026 is acknowledged.
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.
Claim(s) 1, 2, 4, 6, 7, 9, 13-18 and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heasman et al. (Heasman: Pub. No. 2018/0056058).
Regarding claim 1 (with related comments applying to similarly worded, patentably indistinct claims 15 and 20), Heasman discloses a system 105 comprising: a memory 194 storing instructions; and a processor 188 communicatively coupled to the memory and configured to execute the instructions to: determine, intraoperatively during an insertion procedure to introduce an electrode lead of a cochlear implant system into a cochlea of a recipient, an electrical potential evoked in response to acoustic stimulation applied to the recipient as part of a diagnostic test (par. 0006); estimate a depth of the electrode lead within the cochlea (par. 0022), the estimated depth corresponding to the electrical potential resulting from the diagnostic test (pars. 0040, 0088); access recipient attribute data that includes etiological data representative of a mechanism by which the recipient experiences hearing loss and that represents a hearing attribute of the recipient that is correlated to the estimated depth of the electrode lead (par. 0061, aetiology); determine, intraoperatively during the insertion procedure and based on the electrical potential and the recipient attribute data, a likelihood that the electrode lead is inflicting trauma on the cochlea at the estimated depth (pars. 0084-0087, Figs. 4 and 5, where the likelihood of trauma increases when the cochlear microphonic amplitude steadily increases and then significantly drops); and perform, intraoperatively during the insertion procedure, an action based on the likelihood that the electrode lead is inflicting the trauma on the cochlea (continuing insertion if the likelihood of trauma is low; stopping insertion if the likelihood of trauma is high, slowing insertion, or other corrective surgical actions such as retraction and reinsertion, etc. (pars. 0084-0088)).
Regarding claims 2 and 16, see par. 0040.
Regarding claim 4, see pars. 0064, 0069, 0070 and 0072, where acoustic stimulation in the form of multi-tone stimulation (frequency sweep) is applied to gauge the tonotopic position of electrodes based on the acoustic response as recorded by the electrode potentials --thus tracking the depth of the electrode lead. Common sense would dictate that the estimated depth would be based on determining that the electrode has passed a first depth and has yet to pass a second depth (i.e., the electrode is located in a region just after the first depth and before the second depth, in the same manner that a linearly moving object passing a first sensor, but not a second sensor along the path, would naturally be located between the two sensors).
Regarding claims 6 and 7, see pars. 0022 and 0057.
Regarding claim 9 and 18, see pars. 0057, 0060-0061, 0069-0072. A prediction model is determined by taking into account recipient attribute data (e.g., recipient’s age, etiology, etc., used to refine the predictive model) prior to any insertion and thus in the absence of any cochlear trauma. The predictive model is compared to the measured electrical potential in order to determine/predict the likelihood that the electrical potential is exceeding a target stop point (i.e., threshold level).
Regarding claim 13, Heasman teaches to provide feedback to the user/surgeon when a warning or stop condition exists (par. 0086), and that information may be provided to the user/surgeon through the use of display 190 (par. 0094). The intra-operative system may also include a speaker 198 for audible notification.
Regarding claim 14, see par. 0024.
Regarding claim 17, see par. 0022.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
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, David E. 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.
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.
/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
July 31, 2026
Prosecution Insights