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
Applicant’s arguments, see Applicant Arguments/Remarks Made in an Amendment, filed 20 October 2025, with respect to the rejections under 35 U.S.C. § 112 have been fully considered and are persuasive, in light of the amendments. The rejection of claims 3 – 10, 13 – 20 and 23 – 25 under 35 U.S.C. § 112(b) has been withdrawn.
Applicant’s arguments, see Applicant Arguments/Remarks Made in an Amendment, filed 20 October 2025, with respect to the rejection(s) of claim(s) 1 – 25 under 35 U.S.C. § 102/103 have been fully considered and are persuasive, in light of the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the rejections under 35 U.S.C. § 103 below.
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.
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.
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.
Claim(s) 1, 11, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Penninger et al. (US PGPUB 2021/0178160 – previously cited) in view of Noble et al. (US PGPUB 2022/0285005).
Regarding claims 1, 11, and 21, Penninger discloses an implantable electrical stimulation (IES) system, a method, and an apparatus enabling an IES, comprising: an implantable electrode array (e.g. 110) having a plurality of electrode contacts (e.g. 112); an electrical stimulus means for applying the electrical stimulus to at least one stimulating electrode contact of the implantable electrode array (e.g. ¶ 5 – 6); a sensor for sensing and determining a measured evoked compound action potential (ECAP) of the at least one stimulating electrode contact to generate data for determining a plurality of parameters for the at least one stimulating electrode contact of the implantable electrode array (e.g. ¶ 34); and a processing circuitry configured for processing the measured ECAP and the plurality of parameters of the at least one stimulating electrode contact of the implantable electrode array to compute the corresponding parameters for the remaining electrode contacts of the implantable electrode array (e.g. ¶ 34). Penninger fails to teach creating an implantable electrical stimulation (IES) model to calculate a spread of electrical current, and calculating a simulated evoked compound action potential (ECAP) based on the spread of electrical current.
Nobel teaches it is known to use a cochlear implant programming system that creates an implantable electrical stimulation (IES) model to calculate a spread of electrical current, and calculates a simulated evoked compound action potential (ECAP) based on the spread of electrical current. (e.g. ¶ 101). It would have been obvious to one having ordinary skill in the art to modify the invention as taught by Penninger with the model and simulated ECAP as taught by Nobel, since such a modification would provide the predictable results of improving an audiologist’s ability to program a cochlear implant.
Regarding claims 2, 12, 22, 24, and 25, Penninger discloses the sensor, as previously described. Penninger is silent to the time period of sensing, however.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sensing as taught by Penninger in view of Noble with sensing and determining the measured ECAP of the at least one stimulating electrode contact during a prescribed time period of 0.05 - 2 milliseconds after the application of the electrical stimulus and lasts for approximately 0.3-10 milliseconds thereafter, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233] and/or since it has been held that a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ (Please see MPEP 2144.05).
Claim(s) 3 – 9, 13 – 19, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Penninger et al. in view of Noble, and further in view of Brill et al. (US PGPUB 2019/0262609 – in IDS).
Regrading claims 3 – 9, 13 – 19, and 23, Penninger in view of Noble discloses the claimed invention as previously described, but fails to teach the specific claimed models and machine learning models.
Brill teaches it is known to use specific models and machine learning models in a stimulation system and method (¶ 11 – 14 and 79). While Brill teaches using these models in spinal cord stimulation, It solves the same problem of determining optimal parameters for remaining electrode contacts. It would have been obvious to one having ordinary skill in the art to modify the invention as taught by Penninger in view of Noble with the specific models as taught by Brill, since such a modification would provide the predictable results of a modification would provide the predictable results of determining optimal parameters for remaining electrode contacts.
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 JOSEPH M DIETRICH whose telephone number is (571)270-1895. The examiner can normally be reached Mon - Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSEPH M DIETRICH/Primary Examiner, Art Unit 3796