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 Arguments
Claim Rejections Under 35 USC 101
Applicant’s arguments, see pages 9-10, filed on 07/21/2026, with respect to the pending 101 rejection of claims 1-20 have been fully considered and are persuasive. The 101 rejection of claims 1-20 has been withdrawn.
Claim Rejections Under 35 USC 102
Applicant’s arguments, see pages 10-11, filed on 07/21/2026, with respect to the rejection(s) of claim 1 under 35 USC 102 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 Therefore, the rejection has been withdrawn.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 an additional embodiment disclosed by Heasman.
Applicant argues that Heasman fails to disclose “wherein: the one or more stimulation frequencies include a first stimulation frequency and a second stimulation frequency that is different than the first stimulation frequency; and
the first stimulation frequency is not harmonic with respect to the second stimulation frequency.”
Examiner respectfully disagrees and notes that Heasman does disclose wherein:
the one or more stimulation frequencies include a first stimulation frequency and a second stimulation frequency that is different than the first stimulation frequency ([0069] one or more complex acoustic inputs (sound signals) comprising multiple frequencies); and
the first stimulation frequency is not harmonic with respect to the second stimulation frequency ([0073] one or more complex acoustic inputs having specific frequency components of at least 2 kHz, 1.5 kHz, 1 kHz, and 500 Hz are presented to the cochlea 120; Examiner notes that 2KHz is not harmonic with 1.5KHz).
Claim Rejections - 35 USC § 102
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) 1-3, 5, 8-12, and 14-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heasman et al (US 2018/0056058) hereinafter Heasman.
Regarding claims 1, 10, and 17, Heasman discloses a method (Fig. 3), a computer program product embodied on a non-transitory computer readable medium and comprising computer instructions [0095], and a system (Fig. 1B) comprising:
a memory (memory 194) storing instructions [0095]; and
a processor (processors 188) communicatively coupled to the memory and configured to execute the instructions to perform a process [0095] comprising:
obtaining a pre-operative audiogram of a recipient ([0057] one or more pre-operative tests can include an audiogram; Fig. 3: step 176),
the pre-operative audiogram generated prior to a lead insertion procedure during which an electrode lead having a plurality of electrodes is inserted into a cochlea of the recipient ([0032] stimulating assembly 126 is configured to be at least partially implanted in the recipient's cochlea 120 (FIG. 1A) and includes a plurality of longitudinally spaced intra-cochlear electrical stimulating contacts (electrodes) 138; Examiner notes that Fig. 3 shows the pre-operative tests 176 occurring before insertion 180);
obtaining one or more attributes associated with the lead insertion procedure ([0062] results of the pre-operative measurements can also be used to set a minimum insertion depth); and
determining, based on the pre-operative audiogram and the one or more attributes, one or more stimulation frequencies for stimulation that is to be used during the lead insertion procedure to elicit evoked responses within the recipient ([0069] inner ear potential measurements can be used to monitor or track the progression of the stimulating assembly 126 within the cochlea 120 using one or more complex acoustic inputs (sound signals) comprising multiple frequencies),
the evoked responses usable to monitor an insertion condition associated with the electrode lead ([0069] track the progression of the stimulating assembly 126 within the cochlea 120); and
providing the one or more stimulation frequencies to the recipient during the lead insertion procedure ([0073] one or more complex acoustic inputs are presented to the cochlea 120),
wherein:
the one or more stimulation frequencies include a first stimulation frequency and a second stimulation frequency that is different than the first stimulation frequency ([0069] one or more complex acoustic inputs (sound signals) comprising multiple frequencies); and
the first stimulation frequency is not harmonic with respect to the second stimulation frequency ([0073] one or more complex acoustic inputs having specific frequency components of at least 2 kHz, 1.5 kHz, 1 kHz, and 500 Hz are presented to the cochlea 120; Examiner notes that 2KHz is not harmonic with 1.5KHz and 1.5KHz is not harmonic with 1KHz).
Regarding claims 2, 11, and 18, Heasman discloses determining, based on the one or more attributes, a stimulation level to use during the lead insertion procedure for each of the one or more stimulation frequencies ([0073] one or more complex acoustic inputs are presented to the cochlea 120; Examiner notes there would necessarily have to be a determined stimulation level in order to deliver the stimulation).
Regarding claims 3 and 12, Heasman discloses wherein the one or more stimulation frequencies include a plurality of stimulation frequencies that are concurrently used during the insertion procedure to elicit the evoked responses within the recipient ([0069] inner ear potential measurements can be used to monitor or track the progression of the stimulating assembly 126 within the cochlea 120 using one or more complex acoustic inputs (sound signals) comprising multiple frequencies).
Regarding claims 5, 16, and 19, Heasman discloses monitoring, during the lead insertion procedure, the evoked responses elicited within the recipient based on the one or more stimulation frequencies ([0069] inner ear potential measurements can be used to monitor or track the progression of the stimulating assembly 126 within the cochlea 120 using one or more complex acoustic inputs); and
providing, based on the monitoring of the evoked responses, feedback regarding the insertion condition during the lead insertion procedure ([0070] Based on the comparisons, the intra-operative system 105 could determine, for example, current insertion depth, location relative to the predicted depth, etc.).
Regarding claims 8 and 14, Heasman discloses wherein the one or more attributes associated with the lead insertion procedure include one or more of an intended insertion depth based on anatomy or pre-operative imaging ([0060] the results of the pre-operative measurements (e.g., audiogram, CT scan, initial inner potential measurement, etc.) are used to set a target stop point; [0062] results of the pre-operative measurements can also be used to set a minimum insertion depth).
Regarding claims 9 and 15, Heasman discloses wherein the one or more attributes associated with the lead insertion procedure include one or more of a predicted insertion depth, statistical information associated with additional cochlear implant recipients, or system capabilities ([0062] results of the pre-operative measurements can also be used to set a minimum insertion depth).
Claim Rejections - 35 USC § 103
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) 6-7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Heasman (US 2018/0056058) in view of Koka et al (US 2019/0030323) hereinafter Koka.
Regarding claim 6, Heasman discloses wherein the feedback includes a notification [0079], but fails to expressly disclose wherein the feedback includes one or more of an audible sound notification or a graphical notification presented for display by way of a display device. However, Koka discloses wherein the feedback includes one or more of an audible sound notification or a graphical notification presented for display by way of a display device ([0057] monitoring system 600 may notify (e.g., by an audible sound, a visible warning light, a message displayed on a graphical user interface). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Heasman with wherein the feedback includes one or more of an audible sound notification or a graphical notification presented for display by way of a display device as taught by Koka. Such a modification would provide the predictable results of notifying the surgeon that trauma may have occurred at the cochlea (Koka, [0057]).
Regarding claims 7 and 20, Heasman discloses monitoring, during the lead insertion procedure, the evoked responses elicited within the recipient based on the one or more stimulation frequencies ([0069] inner ear potential measurements can be used to monitor or track the progression of the stimulating assembly 126 within the cochlea 120 using one or more complex acoustic inputs (sound signals) comprising multiple frequencies), but fails to disclose determining, based on the monitoring of the evoked responses, that trauma has occurred within the cochlea during the lead insertion procedure.
However, Koka discloses determining, based on the monitoring of the evoked responses, that trauma has occurred within the cochlea during the lead insertion procedure ([0019] during the insertion procedure and based on the determination that the change is greater than the predetermined threshold, the monitoring system may determine that cochlear trauma has likely occurred at the second insertion depth of the intracochlear electrode within the cochlea). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system/method as taught by Heasman with determining, based on the monitoring of the evoked responses, that trauma has occurred within the cochlea during the lead insertion procedure as taught by Koka. Such a modification would provide the predictable results of detecting trauma to the cochlea in real-time as the insertion procedure takes place (Koka, [0001]).
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 WILLOW GRACE WELCH whose telephone number is (703)756-1596. The examiner can normally be reached Usually M-F 8:00am - 4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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