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, claims 1-13 in the reply filed on 4/23/2026 is acknowledged.
Applicant amended claim 14 to depend from Claim 1. However, this does not overcome the one-way distinctness required in restricting a method from an apparatus. In the instant case, the method of Claim 1 does not require any of the apparatus of Claim 14 and thus could be practiced with a materially different device, such as a device that only provides an audible sound or only has one stimulation component. Therefore, the restriction between claims 1-13 and 14-21 is maintained.
Claims 14-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/23/2026.
Applicant’s arguments regarding the species election have been considered and are persuasive. The Examiner notes the auditory stimuli and electrical stimuli (Species C and D) are described in the specification as being the same embodiment. Therefore, the distinction between Species C and D is withdrawn and Applicant’s election of the hearing precept/electrical stimulation species is acknowledged. Claims 1, 2 and 6-13 have therefore been elected. Claims 3-5 are withdrawn since they belong to a non-elected species. The Examiner notes that upon further review of Claim 3, Applicant’s specification defines “deactivating tissue” as ablation (see par. [0055]) which is not elected by Applicant. This claim is not generic and is instead pertinent to only Species A.
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.
Claims 1 and 6-8 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Della Santina et al. (PGPUB 2007/0208403).
Regarding Claims 1 and 6-8, Della Santina discloses adjusting a patient’s vestibular system with electrical stimuli from a vestibular stimulator (par. [0012]) and providing a compensation signal to the patient via one or more non-vestibular channels after or while the vestibular system is adjusted (e.g. applying auditory sensory stimulation via cochlear electrodes of a cochlear implant (par. [0012, 0014, 0083]). Applicant’s specification defines non-vestibular channels as one of “a visual sensory channel, an auditory sensory channels, a tactile sensory channels, other sensor channels, or combinations thereof”, see par. [0027] of the specification.
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.
Claims 2 and 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Della Santina et al. (PGPUB 2007/0208403), herein Santina ‘403, in view of Della Santina et al. (2015/0039057), herein Santina ‘057.
Regarding claim 9, Santina'403 discloses a dual cochlear/vestibular stimulator and method (e.g. paragraphs [0002], [0011], [0014]; claims 9-14) comprising: selecting a recipient having a balance disorder (e.g. abstract; paragraphs [0010], [0011]; stimulating the recipient's vestibular system (e.g. abstract; paragraphs [0008]-[0012], [0028], [0029]); and providing a compensation output signal to the recipient via one or more non-vestibular sensory channels of the recipient (e.g. paragraphs [0010]- [0012], [0028], [0036], [0078], [0083] - wherein the dual cochlear stimulation reads on the non-vestibular sensory channel). 11. Further regarding claim 9, Santina'403 discloses the invention substantially as claimed, but does not expressly disclose wherein the stimulation of the vestibular system is an inhibitory stimulation. However, in the same field of endeavor, Santina'057 teaches a similar hybrid vestibular/cochlear stimulation prosthesis (e.g. abstract; Figs. 2-3). Santina'057 teaches that it is known that delivery of DC and low frequency alternating current (LF-AC) would allow for an implantable system to provide both excitatory and inhibitory vestibular nerve stimulation and that providing such inhibition of the vestibular nerve activity would allow pulse-rate-modulated biphasic current pulse stimuli to assume greater control over the vestibular nerve firing rates, which removes spontaneous neural activity from the pattern of activity conveyed to the CNS giving an unprecedented ability to encode head rotation (e.g. paragraphs [0130], [0132]) which thus increases the dynamic range of encoding and allows the prosthesis full control over afferent spike rates (e.g. paragraph [0133]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Santina'403, with inhibitory stimulation (DC or LF-AC) as taught by Santina'057, since such a modification would provide the predictable results of allowing for an implantable system to provide both excitatory and inhibitory vestibular nerve stimulation which thus increases the dynamic range of encoding and allows the prosthesis full control over afferent spike rates.
Regarding claims 2 and 10, Santina'403 discloses wherein providing the balance compensation output signal to the recipient via the one or more non-vestibular sensory channels includes: encoding data regarding rotation about a roll axis using a first characteristic; and encoding data regarding rotation about a pitch axis using a second characteristic (e.g. paragraphs [0009], [0042]). Santina'057 as it already modifies Santina'403 teaches the same (e.g. paragraphs [0075], [0082]) and further teaches wherein the first and second characteristics are selected from a group consisting of loudness, pitch, stimulation frequency, melody, rhythm, stereo effect, and location (e.g. paragraphs [0027], [0029], [0074], [0075]).
Regarding claim 11, Santina'057 as it modifies Santina'403 discloses delivering stimulation at less than 1 KHz, since it discloses low frequency alternating current stimulation (LF-AC), which is known in the field of neurostimulation to specify a range under 1 KHz.
Regarding claims 12 and 13, Santina'403 as modified discloses the invention substantially as claimed, but does not expressly disclose delivering stimulation at approximately 500 Hz or approximately 900 Hz. However, the disclosed LF-AC stimulation is a finite range of frequencies under 1000 Hz. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method as taught by Santina'403 with stimulation at either approximately 500 Hz or approximately 900 Hz, 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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cushing et al. (2015/0032186), provides for cochlear stimulation and vestibular stimulation;
Capcelea et al. (2012/0143284, provides for cochlear stimulation and vestibular stimulation.
Risi et al. (2012/0130465)
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/ALLEN PORTER/Primary Examiner, Art Unit 3796
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