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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 26 February 2026 has been entered.
Response to Arguments
Applicant’s arguments combined with the claim amendments have been fully considered and are found persuasive with respect to the previous rejection(s); however, upon further search and consideration due to the change in scope, an updated grounds of rejection is presented below, necessitated by amendment.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 16/229,401, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, these parent cases fail to support the claim language of applying an electrical impulse transcutaneously wherein the electrical impulse is sufficient to inhibit an inflammatory response to the virus in the patient. The parent case fails to disclose any support for virus related inflammation.
Accordingly, the present application is awarded a priority date of April 2, 2020.
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 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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.
Claim 1, 4-11, 14-15, 17-19, 22, and 24-31 are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US 2011/0152967; hereinafter “Simon”, in view of Errico et al. (US 2019/0111255; hereinafter “Errico”); further in view of Danielsson et al. (US 2010/0069995; hereinafter “Danielsson”), further in view of Levine et al. (US 2019/0111263; hereinafter “Levine”).
Regarding claim 1, Simon teaches a method of treating a patient exhibiting an inflammatory response associated with a virus, the method comprising: transmitting an electrical impulse transcutaneously through an outer skin surface of the patient near a vagus nerve of the patient based on a treatment regimen (e.g. Abstract, ¶¶ 31-33, etc.), wherein the treatment regimen comprises applying the electrical impulse to the patient, for a time period of about 90 seconds to about 2 minutes (225 – “stimulation may be performed for 1 to 200 minutes”); and wherein the electrical impulse comprises bursts of 2 to 20 pulses (e.g. ¶¶ 34 – “1 to 20 pulses per burst”) with the bursts having a frequency of about 5 Hz to about 100 Hz (e.g. ¶¶ 34 – “15-50 Hz”) and wherein each of the pulses has a duration of about 50 to 1000 microseconds (e.g. ¶¶ 34 – “duration of 20 to 1000 microseconds”), wherein the electrical impulse is sufficient to inhibit an inflammatory response to the virus in the patient (e.g. Abstract – “Reduction in inflammation is effected by enhancing the anti-inflammatory competence of cytokines….”; ¶¶ 2 – “treatment relates to stimulation of the vagus nerve to reduce neuro-inflammation”; ¶¶ 182 – prevent virus toxins, etc.).
Simon fails to expressly disclose transmitting the electrical impulse as a first and second dose, wherein the second dose is applied for a time period of 90 seconds – 2 minutes, wherein the second single dose is applied five minutes or less after the first single dose, wherein the doses are applied about 2-3 times per day.
In the same field of endeavor, Errico discloses applying an electrical impulse as a first and second single dose for a time period of about 90 seconds to 3 minutes (e.g. ¶¶ 177 – “stimulation may be performed for as little as 90 seconds”; “treatment is generally performed…. twice daily”) and further wherein the second single dose is applied five minutes or less after the first single dose (e.g. ¶¶ 94 - “5 minutes OFF (or the like)”) in order to treat a variety of physiological symptoms. Additionally, in the same field of endeavor, Danielsson discloses applying an electrical impulse as a first and second single dose for a time period of about 90 seconds to 3 minutes, wherein the second single dose is applied five minutes or less after the first single dose (e.g. ¶¶ 66 - “A first electrical stimulus …1 minute ON time and 4 minutes OFF time may be applied to a vagus nerve”).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known technique of at least two stimulation doses for a time period of 90 seconds to three minutes, where the second single dose is applied five minutes or less after the first dose and where the two doses are administered each day for a plurality of days, as taught by Errico and Danielsson, to the known device of Simon, to improve the device in a similar manner and allow treatment of a plurality of additional physiological conditions.
Additionally, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, based on the recited sections of Simon, Errico and Danielsson teaching the varying of stimulation parameters as discussed above, to apply a first single dose for 90 seconds to 2 minutes and second single dose for about 90 seconds to 2 minutes, five minutes or less after the first single dose, and apply each dosage about 2-5 times a day, 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) and further 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)).
It is unclear whether Simon discloses that no other electric impulses are applied to the patient during a duration of the treatment regimen. In the same field of endeavor, Levine discloses a variety of different stimulation protocols including application of vagus nerve stimulation for a plurality of days, and where no other impulses are applied during a duration of the treatment regimen (e.g. ¶¶ 66 - “once a day”), in order to provide the most effective treatment, dependent on the patient. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to use the known technique of providing stimulation each day for a plurality of days, where no other electric impulses are applied during the duration of the treatment regimen, as taught by Levine, to improve the similar device of Simon ready for improvement, to yield the predictable results of ensuring that the patient’s treated by Simon have the most effective treatment with the least amount of skin irritation and other physiological negative side effects.
Regarding claims 4-7, Simon discloses the electrical impulse is sufficient to inhibit a release of a pro-inflammatory cytokine such as TNF alpha (e.g. ¶¶ 2, 24) and sufficient to increase an anti-inflammatory competence of a cytokine in the patient such as TGF beta (e.g. ¶¶ 37).
Regarding claims 8-11, Simon teaches the electrical impulse is sufficient to inhibit a release of a pro-inflammatory cytokine (e.g. ¶¶ 29 – “electrical impulse is sufficient to inhibit and/or block the release of pro-inflammatory cytokines”) and further that the invention can directly or indirectly stimulate or otherwise modulate nerves that innervate smooth or skeletal muscle, endocrine glands, and organs of the digestive system (e.g. ¶¶ 120). Simon also teaches the electrical impulse is sufficient to reduce the magnitude of constriction of smooth bronchial muscle (e.g. ¶¶ 63 – “bronchoconstriction”; ¶¶ 120 – “can be used to directly or indirectly stimulate or otherwise modulate nerves that innervate smooth or skeletal muscle”; e.g. ¶¶ 127-128 – “Methods for compensating for motion and other confounding factors were disclosed by the present applicant in co-pending application Ser. No. 12/859,568 entitled Non-Invasive Treatment of Bronchial Constriction, to SIMON, which is hereby incorporated by reference”). In the same field of endeavor, Huston teaches the use of vagal stimulation in order to treat a plurality of viruses, including respiratory viruses where treatment would result in reducing respiratory distress (e.g. ¶¶ 86-87). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the stimulation technique of Simon to treat acute respiratory viruses, as taught by Huston, in order to yield the predictable results of treating a larger range of patients suffering from inflammation from different sources including acute respiratory distress.
Regarding claims 14-15 and 19, Simon teaches the method further comprising: positioning a contact surface of a housing in contact with the neck of the patient (e.g. Fig. 6, #30); generating an electric current from an energy source within the housing (e.g. ¶¶ 73-74); transmitting the electric current transcutaneously and non-invasively from the contact surface through the outer skin surface of the patient such that an electrical impulse is generated at or near the vagus nerve (e.g. ¶¶ 36, 121-128, 224, etc.).
Regarding claims 17-18, Simon indicates a pulse duration of preferably 200 microseconds (e.g. ¶¶ 35 – “10-1000 microseconds”).
Regarding claim 22, Simon teaches a method for treating a patient infected with a virus, the method comprising: transmitting an electrical impulse transcutaneously through an outer skin surface of the patient near a vagus nerve of the patient based on a treatment regimen (e.g. Abstract, ¶¶ 31-33, etc.), wherein the treatment regimen comprises applying the electrical impulse to the patient, for a time period of about 90 seconds to about 2 minutes (225 – “stimulation may be performed for 1 to 200 minutes”); and wherein the electrical impulse comprises bursts of pulses (e.g. ¶¶ 34 – “1 to 20 pulses per burst”) and wherein each pulse has a frequency of 5 Hz (e.g. ¶¶ 35 - “frequency between about 1 Hz to 3000 Hz”); and the electrical impulse is sufficient to inhibit release of pro-inflammatory cytokines and reducing acute respiratory distress associated with the virus (e.g. Abstract – “Reduction in inflammation is effected by enhancing the anti-inflammatory competence of cytokines….”; ¶¶ 2 – “treatment relates to stimulation of the vagus nerve to reduce neuro-inflammation”; ¶¶ 182 – prevent virus toxins, etc.; e.g. ¶¶ 63 – “bronchoconstriction”; ¶¶ 120 – “can be used to directly or indirectly stimulate or otherwise modulate nerves that innervate smooth or skeletal muscle”; e.g. ¶¶ 127-128 – “Methods for compensating for motion and other confounding factors were disclosed by the present applicant in co-pending application Ser. No. 12/859,568 entitled Non-Invasive Treatment of Bronchial Constriction, to SIMON, which is hereby incorporated by reference”).
Simon fails to expressly disclose transmitting the electrical impulse as a first and second dose, wherein the second dose is applied for a time period of 90 seconds – 2 minutes, wherein the second single dose is applied five minutes or less after the first single dose, wherein the doses are applied about 2-5 times per day.
In the same field of endeavor, Errico discloses applying an electrical impulse as a first and second single dose for a time period of about 90 seconds to 3 minutes (e.g. ¶¶ 177 – “stimulation may be performed for as little as 90 seconds”; “treatment is generally performed…. twice daily”) and further wherein the second single dose is applied five minutes or less after the first single dose (e.g. ¶¶ 94 - “5 minutes OFF (or the like)”) in order to treat a variety of physiological symptoms. Additionally, in the same field of endeavor, Danielsson discloses applying an electrical impulse as a first and second single dose for a time period of about 90 seconds to 3 minutes, wherein the second single dose is applied five minutes or less after the first single dose (e.g. ¶¶ 66 - “A first electrical stimulus …1 minute ON time and 4 minutes OFF time may be applied to a vagus nerve”).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known technique of at least two stimulation doses for a time period of 90 seconds to three minutes, where the second single dose is applied five minutes or less after the first dose and where the two doses are administered each day for a plurality of days, as taught by Errico and Danielsson, to the known device of Simon, to improve the device in a similar manner and allow treatment of a plurality of additional physiological conditions.
Additionally, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, based on the recited sections of Simon, Errico and Danielsson teaching the varying of stimulation parameters as discussed above, to apply a first single dose for 90 seconds to 2 minutes and second single dose for about 90 seconds to 2 minutes, five minutes or less after the first single dose, and apply each dosage about 2-5 times a day, 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) and further 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)).
It is unclear whether Simon discloses that no other electric impulses are applied to the patient during a duration of the treatment regimen. In the same field of endeavor, Levine discloses a variety of different stimulation protocols including application of vagus nerve stimulation for a plurality of days, and where no other impulses are applied during a duration of the treatment regimen (e.g. ¶¶ 66 - “once a day”), in order to provide the most effective treatment, dependent on the patient. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to use the known technique of providing stimulation each day for a plurality of days, where no other electric impulses are applied during the duration of the treatment regimen, as taught by Levine, to improve the similar device of Simon ready for improvement, to yield the predictable results of ensuring that the patient’s treated by Simon have the most effective treatment with the least amount of skin irritation and other physiological negative side effects.
Regarding claims 24-26, Simon discloses the electrical impulse is sufficient to inhibit a release of a pro-inflammatory cytokine such as TNF alpha (e.g. ¶¶ 2, 24) and sufficient to increase an anti-inflammatory competence of a cytokine in the patient such as TGF beta (e.g. ¶¶ 37).
Regarding claims 27-29, Simon teaches the method further comprising: positioning a contact surface of a housing in contact with the neck of the patient (e.g. Fig. 6, #30); generating an electric current from an energy source within the housing (e.g. ¶¶ 73-74); transmitting the electric current transcutaneously and non-invasively from the contact surface through the outer skin surface of the patient such that an electrical impulse is generated at or near the vagus nerve (e.g. ¶¶ 36, 121-128, 224, etc.).
Regarding claims 30-31, Simon teaches the method comprising an electrical impulse comprises bursts of 2-20 pulses with the bursts having a frequency of about 5-100 Hz, and wherein each of the pulses has a duration of about 50-1000 microseconds (e.g. ¶¶ 34).
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Errico, further in view of Danielsson, further in view of Levine, further in view of Huston et al. (US 2009/0143831; hereinafter “Huston”). Simon fails to expressly disclose the virus contains a sensitizing or allergic protein that triggers an inflammatory response in the patient or that the virus is in the coronaviridae family. The examiner notes that the present application’s disclosure does not appear to offer any specific stimulation parameters, discussion, or details as to how the stimulation applied to a virus in the coronaviridae family would differ from any other viruses and medical disorders listed throughout applicant’s disclosure (e.g. ¶¶ 97-98 – i.e. “Parkinson’s Disease”). Additionally, the claims require no specific stimulation parameters other than the dosage which is obviated as indicated above. Simon also indicates treating a plurality of different medical conditions including different viruses causing inflammation (e.g. Abstract – “Reduction in inflammation is effected by enhancing the anti-inflammatory competence of cytokines….”; ¶¶ 2 – “treatment relates to stimulation of the vagus nerve to reduce neuro-inflammation”; ¶¶ 182 – prevent virus toxins, etc.).
In the same field of endeavor, Huston teaches vagal stimulation in order to treat a plurality of viruses which contain a protein triggering the cytokine (protein) cascade (e.g. ¶¶ 13, 86-87, etc.) in order to reduce inflammation in the patient. It would have been obvious to apply the known technique of vagal stimulation to treat a virus containing a sensitizing or allergic protein, or a virus in the coronaviridae family, as Huston treats a plurality of similar viruses, to the known device of Simon, in order to treat a patient suffering from inflammation in the same manner, as known work in one field of endeavor may prompt variations of it for use in either the same field or a different one, if the variations are predictable to one of ordinary skill in the art.
In this situation, the predictability would be in treating the inflammation from any viral condition whether it stems from Parkinson’s or coronaviridae. Additionally, based on the plurality of viruses listed as treatable by Huston (e.g. ¶¶ 86-87), it would have been obvious to one of ordinary skill in the art to apply the same therapy to different viruses related to coronavidae or containing a sensitizing or allergic protein, expected to induce inflammation, with a reasonable expectation of success in inhibiting the inflammatory response as they work within the same immunologic pathways.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Errico, further in view of Danielsson, further in view of Levine, further in view of Tracey et al. (USP# 9,662,490). Simon fails to expressly disclose activating a sympathetic fiber in a splenic nerve to release norepinephrine into a spleen to release acetylcholine. In the same field of endeavor, Tracey discloses a device which transfers electrical current through the neck of the patient (e.g. Abstract) and further where sympathetic fibers in a splenic nerve are tied into vagal stimulation to release norepinephrine into a spleen to release acetylcholine, in order to properly attenuate TNF (e.g. Cols 5-6, etc.). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to use the known technique and similar stimulation scheme and parameter as taught by Tracey, into the stimulation regimen of Simon, in order to yield the predictable results of providing an expected improvement of attenuation or inhibition of TNF in the patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796