DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 December 23, 2025 has been entered.
Response to Amendment
This Action is in response to the RCE filed on January 6, 2026 entering the Amendment filed 12/23/2025.
Claims 1, 6, and 14 are amended.
Claims 12 and 19 are canceled.
Claims 1-11 and 14-18 are pending.
Terminal Disclaimer
The four Terminal Disclaimers (TDs) filed 12/23/2026 are disapproved because the registration number of the signing attorney is incorrect. Please correct the registration number and resubmit the TDs (no new fee is required).
Response to Arguments
Applicant's arguments filed 12/23/2025 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. Thus, the rejections on the ground of nonstatutory double patenting are maintained.
As to the rejection under 35 USC 103, Applicant argues that US Patent Application No. 2007/0027486 to Armstrong does not teach or describe the positioning a contact surface of a device in contact with an outer skin surface of a neck of a user; and applying, via the device, an electrical impulse to a cervical branch of a vagus nerve within the user according to a treatment paradigm as recited in claims 1 and 4. The Examiner notes that the primary reference US Patent Application Publication No. 2011/009878 to Mantle teaches the positioning step, except for the location (i.e., neck), applying an electrical impulse via the device and the treatment paradigm, but does not expressly mention that the treatment is applied to a cervical branch of the vagus nerve.
Armstrong is a secondary reference that teaches one of ordinary skill to provide an electrical neurostimulation therapy to a patient in order to alleviate pain, sleep disorders, and depression (e.g., paragraph [0163] of Armstrong) where the electrical stimulation is applied to the vagus nerve in the neck (i.e., cervical region) of the patient (e.g., paragraph [0117] of Armstrong) and teaches that one of ordinary skill in the art would have recognized that Armstrong’s invention could be fully non-implantable, such as a transcutaneous stimulation device (e.g., paragraph [0097] of Armstrong).
At the very least one of ordinary skill in the art, upon reading Armstrong, would have also recognized the desirability of treating pain. Since Armstrong teaches a fully non-implantable device that applies electrical pulses/impulses to a selected cranial nerve or a vagus nerve (e.g., paragraphs [0103] and [0105]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try applying electrical impulses transcutaneously of Mantle in the neck region as the pain treatment in order to order to block pain signals in the vagus nerve in view of the teachings of Armstrong and since a person with ordinary skill has good reason to pursue the known options within his or her grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (See KSR International Co. v. Teleflex Inc.).
Thus, one of ordinary skill in the art, reading Armstrong’s disclosure, would have recognized that a device positioning its contact surface in contact with an outer skin surface of a neck of the user could be used to apply electrical pulses/stimulation to the vagus nerve in view of the teachings of Armstrong. Consequently, one of ordinary skill in the art would have modified the electrical impulse treatment method of Mantle for treating pain to position the contact surface in contact with an outer skin of a neck of the user so that electrical stimulation is applied to the vagus nerve in view of the teachings of Armstrong that such was known to those skilled in the neurostimulation art to treat pain and other disorders of the patient.
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. 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. This also applies to the following US patents: 11,191,953: 11,389,646: 11,779,756.
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. 2007/0027486 to Armstrong.
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 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; and applying the electrical impulse through the neck of the user to a cervical branch of a vagus nerve. Armstrong discloses a similar transcutaneous nerve stimulator (see paragraph [0097]: While medical device 100 is described preferably as implantable, a person of ordinary skill in the art would recognize that the present invention may be fully non-implantable, such as a transcutaneous stimulation device) wherein the nerve is a vagus nerve (see paragraphs [0103]-[0105]: electrodes provide a predetermined sequence of electrical pulses to the vagus nerve) and electrical pulses are applied via electrodes to the patient’s neck, i.e., cervical region (e.g., paragraph [0117]: vagus nerve stimulation therapy is allowed to the patient’s neck). It would have been obvious to one of ordinary skill in the art at the time of the invention to stimulate the vagus nerve because Armstrong teaches it can help alleviate pain conditions (see paragraph [0163]).
At the very least one of ordinary skill in the art, upon reading Armstrong, would have also recognized the desirability of treating pain. Since Armstrong teaches a fully non-implantable device that applies electrical pulses/impulses to a selected cranial nerve or a vagus nerve (e.g., paragraphs [0103] and [0105]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to try applying electrical impulses transcutaneously of Mantle in the neck region as the pain treatment in order to order to block pain signals in the vagus nerve in view of the teachings of Armstrong and since a person with ordinary skill has good reason to pursue the known options within his or her grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (See KSR International Co. v. Teleflex Inc.).
Alternatively, one of ordinary skill in the art, reading Armstrong’s disclosure, would have recognized that a device positioning its contact surface in contact with an outer skin surface of a neck of the user could be used to apply electrical pulses/stimulation to the vagus nerve in view of the teachings of Armstrong. Consequently, one of ordinary skill in the art would have modified the electrical impulse treatment method for treating pain of Mantle to position the contact surface in contact with an outer skin of a neck of the user so that electrical stimulation is applied to a cervical branch of the vagus nerve in view of the teachings of Armstrong that such was known to those skilled in the neurostimulation art to treat pain and other disorders of the patient.
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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US Patent Application Publication No. 2011/0046432 to Simon et al. discloses a non-invasive treatment of bronchial constriction (treating a symptom of a user – see paragraphs [0067] and [0073]) and teaches that the vagus is not the only nerve that may be stimulated non-invasively using magnetic stimulation (e.g., paragraph [0086]) and a nerve modulating device for delivering impulses of energy to treat symptoms of the user/patient (e.g., paragraph [0087]) is placed on the side of the patient’s neck to stimulate the vagus nerve non-invasively at the level of the first to sixth cervical vertebra (e.g., paragraph [0088]). The Examiner notes that patent application document is by the same Applicant, but a different inventive entity, and the instant application cannot rely on the filing date of this application as this patent application document fails to disclose the treatment paradigm of the claims.
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.
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/CATHERINE M VOORHEES/Primary Examiner, Art Unit 3792