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 amendments and associated arguments filed 7/27/2026 with respect to the Double Patenting and 102 rejections of the claims have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of US 2010/0268313 and/or US 2020/0206499.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-6, 8-10, 12, 14, 39 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Conn (US 2010/0268313) in view of Carter (US 2020/0206499).
Regarding claims 1-3, 10 and 42, Conn discloses a method wherein a mastoidectomy is performed by making an incision in an outer ear of a recipient (see figure 3 and par. 0039). A stimulation assembly 140 is implanted and secured within the incision adjacent (i.e., “near”) to an external auditory canal, as seen in figure 3 (par. 0035). The assembly is used to stimulate a neural structure in the vicinity to stimulate the auditory system (par. 0030). Conn is silent as to specifically stimulating the afferent branch/trunk of the auricular branch of the vagus nerve.
Carter also teaches a stimulation assembly for stimulating the auditory system of a patient (see abstract). Specifically, Carter discloses that one can stimulate the afferent branch/trunk of the auricular branch of the vagus nerve in order to stimulate the auditory system and treat the patient (par. 0046, 0014). Therefore, it would have been obvious to one of ordinary skill in the art before the applicant’s effective filing date to modify Conn to specifically stimulate the afferent branch/trunk of the auricular branch of the vagus nerve as taught by Carter as Carter teaches this nerve portion to be effective in stimulating the auditory system and treat the patient, as is the overall purpose/goal of Conn.
Regarding claim 4, Conn discloses that the assembly 140 is a ball electrode (par. 0035). Therefore, the electrode will have a portion that points towards a skull and a portion that points toward the auricular branch of a vagal nerve given that the ball is electrically active in all directions.
Regarding claims 5-6, 8 and 14, Conn discloses stimulating between electrode 140 and a reference/ground electrode 160 (i.e., “second vagal nerve stimulation assembly”), the two electrodes considered a subset of the electrodes (par. 0016, 0045).
Regarding claim 9, Conn discloses there can be a plurality of electrodes 140 (par. 0035).
Regarding claim 12, the electrode 140 is anchored by screwing the assembly into bone (par. 0036).
Regarding claim 39, as seen in figure 3, the incision is at an underside of the pinna.
Allowable Subject Matter
Claims 7, 40 and 41 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 Eric D Bertram whose telephone number is (571)272-3446. The examiner can normally be reached Monday-Friday 8am-6pm Central Time.
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, 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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/Eric D. Bertram/Primary Examiner, Art Unit 3796
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