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”, filed 11/11/2025, regarding the 112(a) rejection has been fully considered and are persuasive. The 112(a) rejection has been withdrawn.
The Examiner notes a typographical error in the heading and preamble of the 103 rejection, as it originally stated the 103 rejection was directed to Claims 47-48, when it should have read to Claims 48-49. The error has been fixed below.
Applicant's arguments filed 11/11/2025 regarding the rejections under U.S.C. 102 have been fully considered but they are not persuasive. Simon teaches the usage of time-varying signals in the stimulation in Para. 0081, “In a more general embodiment of the system shown in FIG. 1B, a cutaneous biofeedback signal may be superimposed upon the electrical stimulation waveform that preferentially stimulates the vagus nerve directly. Thus, in addition to the mechanisms described in the previous two paragraphs, the stimulation waveform may also contain a time-varying signal with frequency components that are designed specifically to stimulate cutaneous nerves”, and Para. 0082 also discloses time-adjusted direct stimulation.
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.
Claims 40-47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 20140324118 awarded to Simon et al, hereinafter Simon.
Regarding Claim 40, Simon teaches a method of treating a patient (abstract) comprising: energizing a stimulatory device including an electrode via electrical pulses having a time-varying duration encoding a treatment signal communicated to a patient during a treatment (Para. 0081, “In a more general embodiment of the system shown in FIG. 1B, a cutaneous biofeedback signal may be superimposed upon the electrical stimulation waveform that preferentially stimulates the vagus nerve directly. Thus, in addition to the mechanisms described in the previous two paragraphs, the stimulation waveform may also contain a time-varying signal with frequency components that are designed specifically to stimulate cutaneous nerves”, and Para. 0082 also discloses time-adjusted direct stimulation); entraining the electrical activity of the autonomic nervous system of the patient to the treatment signal (Para. 0163); and modulating imbalanced activity between parasympathetic activity and sympathetic activity on the basis of the entrainment of the electrical activity of the autonomic nervous system of the patient to the treatment signal (Para. 0033); wherein modulating the imbalanced activity includes modulating the autonomic nervous system in a zone representing a characteristic type of autonomic dysfunction (Para. 0035).
Regarding Claim 41, Simon teaches the method of Claim 40, further including reducing an imbalance between parasympathetic activity and sympathetic activity based on the modulation of the imbalanced activity (Para. 0082, “An embodiment of that example would occur when the individual uses galvanic skin response biofeedback alone to consciously reduce sympathetic tone through muscular and emotional modulation, whereupon the device in FIG. 1B senses that reduction through its programming and then amplifies the effect by increasing parasympathetic tone after a brief time delay, by directly stimulating vagal parasympathetic efferent nerve fibers”).
Regarding Claim 42, Simon teaches the method of Claim 40, wherein the energizing the stimulatory device includes stimulating the vagus nerve in the patient (Para. 0082).
Regarding Claim 43, Simon teaches the wherein the stimulating the vagus nerve includes stimulating the auricular branch of the vagus nerve in the patient (Para. 0065, “Similarly, the vagus nerve axons at that cervical location serve many more functions than branches of the vagus nerve at other locations, such as auricular branch at the tragus of the ear”).
Regarding Claim 44, Simon teaches the method of Claim 40, wherein the zone is characterized by a parasympathetic activity higher than a desired parasympathetic activity (Para. 0247, “When the locus ceruleus is activated through vagus nerve stimulation, it will respond by increasing norepinephrine secretion, which in turn will alter cognitive function through the prefrontal cortex, increase motivation through nucleus accumbens, activate the hypothalamic-pituitary-adrenal axis, and increase the sympathetic discharge/inhibit parasympathetic tone through the brainstem. Such inhibition of parasympathetic tone will specifically inhibit the parasympathetic pathway via the superior salivatory nucleus, thereby blocking the positive feedback loop that contributes to the maintenance of migraine pain”).
Regarding Claim 45, Simon teaches the method of Claim 40, wherein the zone is characterized by a parasympathetic activity lower than a desired parasympathetic activity (Para. 0245, “An embodiment of that example would occur when a migraineur uses galvanic skin response biofeedback alone to consciously reduce sympathetic tone through muscular and emotional modulation, whereupon the device senses that reduction through its programming and then amplifies the effect by increasing parasympathetic tone after a brief time delay, by directly stimulating vagal parasympathetic efferent nerve fibers”).
Regarding Claim 46, Simon teaches the method of Claim 40, wherein the zone is characterized by a sympathetic activity higher than a desired sympathetic activity (Para. 0082, “An embodiment of that example would occur when the individual uses galvanic skin response biofeedback alone to consciously reduce sympathetic tone through muscular and emotional modulation, whereupon the device in FIG. 1B senses that reduction through its programming and then amplifies the effect by increasing parasympathetic tone after a brief time delay, by directly stimulating vagal parasympathetic efferent nerve fibers”).
Regarding Claim 47, Simon teaches the method of Claim 40, wherein the zone is characterized by a sympathetic activity lower than a desired sympathetic activity (Para. 0247, “When the locus ceruleus is activated through vagus nerve stimulation, it will respond by increasing norepinephrine secretion, which in turn will alter cognitive function through the prefrontal cortex, increase motivation through nucleus accumbens, activate the hypothalamic-pituitary-adrenal axis, and increase the sympathetic discharge/inhibit parasympathetic tone through the brainstem. Such inhibition of parasympathetic tone will specifically inhibit the parasympathetic pathway via the superior salivatory nucleus, thereby blocking the positive feedback loop that contributes to the maintenance of migraine pain”).
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.
Claims 48-49 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 20140324118 awarded to Simon et al, hereinafter Simon, in view of U.S. Patent Publication 20170304628 awarded to Lian et al, hereinafter Lian.
Regarding Claims 48-49, Simon teaches the method of Claim 40. Simon does not teach wherein the zone is characterized by a parasympathetic activity lower than a desired parasympathetic activity, and a sympathetic activity lower than a desired sympathetic activity lower than a desired sympathetic activity, but does disclose adjusting parasympathetic/sympathetic tone avoid heart complications (Para. 0126).
However, in the art of vagus nerve stimulation, Lian teaches adjusting the dual autonomic tone to meet the desired outcome of the patient (Para. 0084, “In a preferred version of the invention, hysteresis is used to control VNS. Generally, within a predetermined range of autonomic tone (e.g., a predefined HR range), the intensity of VNS gradually increases when the sensed autonomic tone is shifting toward more sympathetic dominance (e.g., HR increase), and gradually decreases when the sensed autonomic tone is shifting toward more parasympathetic dominance (e.g., HR decrease). The increase and decrease of VNS intensity follow two different curves. At a specific autonomic tone within the predetermined range (e.g., a specific HR within the predefined HR range), the VNS intensity is higher if autonomic tone is shifting toward more parasympathetic dominance (e.g., HR decrease) than the VNS intensity would be if autonomic tone was shifting toward more sympathetic dominance (e.g., HR increase).”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Simon by Lian, i.e. by adjusting a patient’s treatment to remain in the appropriate dual autonomic zone required by the patient’s needs in the method of Simon as in the system of Lian, for the predictable purpose of using the methodology of Lian to improve similar devices in the same way.
Allowable Subject Matter
Claims 1, 24-27, and 30-32 are allowed.
The following is an examiner’s statement of reasons for allowance: With the filing of the TD on 11/09/2025, the double patenting rejections have been withdrawn. No further rejections were previously applied to the claims, and further search and consideration has not found any outstanding issues or prior art to apply.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 Jess Mullins whose telephone number is (571)-272-8977. The examiner can normally be reached between the hours of 9:00 a.m. to 5:00 p.m. PST M-F.
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/JLM/
Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792