DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Claims 1-11 and 14-18 are deemed to have an effective filing date of July 29, 2013.
Response to Amendment
This Action is in response to the Amendment filed on May 26, 2026.
Claims 1 and 14 are amended.
Claims 1-11 and 14-18 are pending.
Terminal Disclaimer
While the Remarks of the 05/26/2026 Amendment indicate that Applicant has resubmitted a terminal disclaimer with this response. No terminal disclaimer was attached to the Amendment filed on 05/26/2026.
Response to Arguments
Applicant's arguments filed 05/26/2026 have been fully considered but they are not persuasive.
With respect to the rejections on the ground of nonstatutory double patenting, as stated above the four Terminals disclaimers filed on 12/23/2026 were not approved. In addition, the updated search developed a reference along with the Mantle reference that meets the newly added limitations. Thus, the rejections on the ground of nonstatutory double patenting are maintained.
As to the rejection under 35 USC 103, Applicant argues that the new limitations are not taught by Mantle or Armstrong. However, as stated above, an updated search developed US Patent Application Publication Nos. 2012/0029601 (Pub. Date: 02/02/2012) and 2011/0276106 (Pub Date: 11/10/2011) to Simon.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 8 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-11 and 14-18 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application Publication No. 2011/009878 to Mantle et al. (hereinafter referred to as “Mantle”) in view of US Patent Application No. 2012/0029601 to Simon.
Regarding Claims 1-2 and 14, Mantle discloses a method of treating a symptom in a user, the method comprising: positioning a contact surface of a device in contact with an outer skin surface of the user (see Fig. 7, paragraphs [0027] and [0031]); applying, via the device, an electrical impulse transcutaneously, via the contact surface, through the outer skin surface of the user to a nerve within the user wherein the electrical impulse has a frequency of 1 kHz to about 20 kHz (e.g., paragraph [0038]: the frequency range used for electrostimulation is from 10 kilohertz (KHz) to 19KHz) according to a treatment paradigm (see paragraphs [0028] and [0036]: microcurrent electrostimulation therapy includes transcutaneous electrical nerve stimulation and provides pain relief); and wherein the treatment paradigm is based at least in part on an application of the electrical impulse as a single dose from about 30 seconds to about 5 minutes and wherein the treatment paradigm comprises a treatment session during a day, wherein the treatment session comprises applying the single dose from 2 to 5 times during the day (see paragraph [0088]). Mantle does not explicitly disclose positioning a contact surface of a device in contact with an outer skin surface of a neck of a user; the voltage of the electrical impulse, and applying the electrical impulse through a sternocleidomastoid in a neck of the user to a cervical branch of a vagus nerve. However, Simon, in a related art: devices and methods for non-invasive electrical stimulation of the vagus nerve on the neck of the patient, teaches that it was known in the stimulation art to stimulate the vagus nerve of the patient by positioning a contact surface in contact with the neck of the user (e.g., see Fig. 6 and paragraph [0122]), applying, via the stimulation device, an electrical impulse transcutaneously through the outer skin surface of the neck of the user, wherein the electrical impulse has an amplitude of 2 to 12 volts and a frequency 1 kHz to about 20KHz (e.g., abstract, paragraphs [0025]: the stimulator is configured to induce a peak pulse voltage sufficient to produce an electric field in the vicinity of the vagus nerve to cause the nerve to depolarize and reach the action potential propagation of 8V/m at 1000 Hz (1 KHz); [0055]: the stimulating impulse signal has a frequency and amplitude selected to influence the therapeutic result, stimulating the selected nerve; and [0122]: Fig. 6), and the amplitude and frequency of the electrical impulse is sufficient to penetrate through a sternocleidomastoid muscle to stimulate the vagus nerve (e.g., paragraphs [0120]-[0121]: the vagus nerve is stimulated at the patient’s neck within the carotid sheath below the sternocleidomastoid muscle and [0025] and [0055] above). Accordingly, one of ordinary skill in the art would have recognized the benefit of positioning a contact surface of a device in contact with a neck of a user, applying, via the device, an electrical impulse with an amplitude of 2 to 12 volts and a frequency of 1kHz to about 20kHz to penetrate the sternocleidomastoid muscle in order to stimulate the vagus nerve in view of the teachings of Simon. Consequently, one of ordinary skill in the art would have modified the method of Mantle to apply transcutaneously an electrical impulse of the specified voltage range and frequency range in order to penetrate a sternocleidomastoid muscle and provide the therapeutic stimulation to the vagus nerve in view of the teachings of Simon that such was a known stimulation protocol in the non-invasive vagus nerve stimulation art, and because the combination would have yielded a predictable result.
Regarding Claims 3 and 15, Mantle discloses wherein the device comprises a housing (see housing 112; paragraph [0029]) and an energy source (see microcurrent source 130; paragraph [0030]), wherein the energy source is located within the housing (see Fig. 5), wherein the contact surface is coupled to the energy source (see electrodes 132, 134 on flat face 140; paragraph [0030]), and wherein the housing comprises an outer surface that includes the contact surface (see paragraphs [0030] and [0064]: flat face 140; Fig. 1-2), wherein the energy source generates the electrical impulse (see paragraph [0037]).
Regarding Claims 4-6, Mantle generally mentions dosing within a treatment session (see paragraphs [0079]: Atypical time period is 120 seconds or two minutes per treatment area; and [0088]: A typical treatment starts with a total of five treatments where each treatment is under 2 minutes). Armstrong mentions programming an on-time and off- time: wherein each single dose is applied within 5 minutes of each other (see paragraph [0111] of Armstrong: neurostimulator may be programmed to deliver electrical biasing signal every five minutes), but does not disclose the specific programs recited in claims 5-6. It would have been obvious to one of ordinary skill in the art at the time of the invention to apply a single dose 2-4 times in one hour and a single dose twice within a 15-minute period since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art (In re Boesch, 617 F.2d 272,205 USPQ 215 (CCPA 1980)).
Regarding Claim 7, Mantle discloses wherein the device comprises one or more electrodes (see electrodes 132 and 134).
Regarding Claims 8 and 16, Mantle discloses wherein the electrical impulse has a frequency from about 1 kHz to about 20 kHz (see paragraph [0038]: the frequency range is from 10 kHz to 19 kHz).
Regarding Claim 9, Mantle does not elaborate on the treatment session specifics. Armstrong teaches wherein the electrical impulse comprises bursts of pulses, wherein the bursts each have a frequency (see paragraph [0111]: neurostimulation has frequently been delivered as a pulsed electrical signal in discrete stimulation periods known as pulse bursts having a programmed, non-random and constant current, a program frequency, e.g., 30 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 Mantle in view of Armstrong a burst frequency from about 1 burst per second to about 100 bursts per second, 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].
Regarding Claims 10, Armstrong further teaches wherein each of the bursts contains from 2 to 20 pulses and each of the pulses is from about 100 microseconds to about 1000 microseconds in duration (see paragraphs [0111] - [0114]:pulse bursts constitute a series of controlled pulses where each pulse is 500 microseconds; all pulses within the burst are provided with the same magnitude). The examiner considers a burst-to-burst interval requires at least two pulses. Accordingly, one of ordinary skill in the art would have recognized the benefits of bursts of pulses containing from 2 to 20 pulses and each of the pulses is from about 100 microseconds to 1000 microseconds in view of the teachings of Armstrong. Consequently, one of ordinary skill in the art would have modified the method of Mantle in view of Armstrong to have bursts containing 2 to 20 pulses where each pulses is from about 100 to 1000 microseconds in duration in view of the teachings of Armstrong that such parameters were known to those skilled in the electrical stimulation art and 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].
Regarding Claims 11 and 18, Armstrong further teaches wherein the symptom is one of stress, withdrawal from substances, addiction, depression or lack of sleep (see paragraphs [0096]: vagal activity or activity of the vagus nerve plays a significant role in regulating mood, such as depression; and [0163]: electrical stimulus provide to a patient’s vagus never can improve neuropsychiatric disorders including depression, obsessive-compulsive disorders, alleviate pain, and sleep disorders). It would have been obvious to one of ordinary skill to treat stress, depression, or addiction because Armstrong teaches the low level stochastic stimulation may result in improvement when it comes to these disorders (see paragraph [0163]).
Regarding claim 17, see the rejection of claims 9-10 above.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-11 and 14-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,441,780 in view of US Patent Application Publication No. 2011/009878 to Mantle et al. (hereinafter referred to as Mantle”) and US Patent Application Publication No. 2012/0029601 to Simon et al. (hereinafter referred to as “Simon”). Although the claims at issue are not identical, they are not patentably distinct from each other because both disclose positioning a contact surface of a device in contact with an outer skin surface, applying, via the device contact surface, an electrical impulse transcutaneously through the outer skin of the neck to a vagus nerve of the patient according to a treatment paradigm of a treatment dose of 30 seconds to 5 minutes, 2 to 5 times a day. Mantle and Simon teach the features of the newly added limitation as discussed above. This double patenting rejection also applies to the following US patents: 11,191,953: 11,389,646: 11,779,756.
Claims 1 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,894,148 in view of Simon.
Claim 1 of the instant application is conflicting or coextensive with claim 1 of the ‘148 patent, except for the recitation that the electrical impulse passes through a sternocleidomastoid muscle. However, as discussed above with respect to the rejection of claim 1, Simon teaches that it was a known protocol to apply an electrical impulse at the neck of user through the sternocleidomastoid muscle in order to stimulate the vagus nerve.
Claim 10 of the instant application is conflicting or coextension with claim 11 of the ‘148 patent.
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 CATHERINE M VOORHEES whose telephone number is (571)270-3846. The examiner can normally be reached Monday-Friday 8:30 AM to 4:30 PM.
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, Unsu Jung can be reached at 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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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792
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