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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 13, 2025 has been entered. Currently claims 1, 7-8, 17-25 are pending in this application with claims 17-23 withdrawn from consideration.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 7-8 have been considered but are not persuasive inasmuch as they apply to the amended rejections required by the amendments to the claims.
Applicant argues that it would not have been an obvious design choice to take the off time of 5 seconds as taught by Gliner and instead use an off-time of 7-10 seconds. This is not found persuasive. Applicant’s specification and previous claims have stated that ranges between 0.5 second and 10 seconds, as well as between 0.5 second and 3 seconds and 7-10 seconds. Examiner asserts that a 5 second off cycle as taught by Gliner would include the same advantages as the 7-10 second off cycle of the current invention, and that the change from 5 seconds to 7 seconds would be an obvious design choice.
Applicant's arguments focus on a 30 seconds on / 60 second off cycle has disadvantages. Examiner still asserts that the relative difference between a 5 second and a 7 second off cycle do not face the same disadvantages of a 30 second on / 60 second off cycle and it would have been an obvious design choice to modify Gliner. Applicant has not specifically shown why the 5 second off time would be materially different than the 7-10 second off time as taught by the claims.
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.
Claims 1, 7-8, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Gliner et al. (US 2006/0015153).
Regarding claim 1, Gliner discloses a method increasing a sensory acuity of a subject (e.g. treatment of the conditions as listed in [0041] will necessarily increase sensory acuity of the subject), comprising applying a stimulus to a vagus nerve of the subject (e.g. stimulating via electrode assembly 150 that can include electrical contacts 152 for stimulating a vagus or over cranial nerve, [0062]); wherein the stimulus is cyclically switched on and off, with an off time that is between 0.5 and 10 seconds (e.g. as shown in Figure 7B, wherein the stimulation off time is T2 = 5 seconds; [0108]).
Gliner does not expressly disclose an an off time between 7 and 10 seconds, but rather discloses an off time of 5 seconds. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the off time as taught by Gliner with the desired off time, because Applicant has not disclosed that such an off time provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the representative off time as taught by Gliner, because it provides a reliable off time and since it appears to be an arbitrary design consideration which fails to patentably distinguish over the prior art. Therefore, it would have been an obvious matter of design choice to modify Gliner to obtain the invention as specified in the claims.
Regarding claim 7, Gliner discloses wherein applying comprises applying the stimulus to a vagus nerve of a subject having one or more impaired senses (e.g. treatment of the conditions as listed in [0041] will necessarily have impaired senses).
Regarding claim 8, Gliner additionally discloses wherein the applying comprises applying the stimulus to a vagus nerve of a subject who has a condition selected from the group consisting of aging, traumatic brain injury (TBI), neurological disorders, fatigue, inattention, and neurodegeneration (e.g. neurological disorders including stroke, traumatic brain injury (TBI), Cerebral Palsy, Multiple Sclerosis, dementia, Alzheimer's disease and others as listed in [0104]).
Regarding claim 24, Gliner discloses a stimulus that has a frequency between 0.5 and 80 Hz (e.g. 50 Hz; [0128]).
Regarding claim 25, Gliner discloses a stimulus that has a frequency between 30 and 60 Hz (e.g. 50 Hz; [0128]).
Regarding claim 26, Gliner additionally discloses wherein the stimulus is cyclically switched on and off, with an off time that is between 0.5 and 10 seconds (e.g. as shown in Figure 7B, wherein the stimulation off time is T2 = 5 seconds; [0108]).
Regarding claim 28, Gliner additionally discloses wherein the stimulus is cyclically switched on and off, with an off time that is between 3 and 7 seconds (e.g. as shown in Figure 7B, wherein the stimulation off time is T2 = 5 seconds; [0108]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached on 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Amanda K Hulbert/ Primary Examiner, Art Unit 3792
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