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 combined with the claim amendments have been fully considered but are not found persuasive. Although the applicant has limited the stimulation protocol to “consists of apply only the first and second doses”, in addition to the use of the previous “consists of” language, the examiner notes that due to the open ended term “comprising” in the preamble, there can be other “applying” electrical current according to other stimulation protocols. Accordingly, prior art like those cited below, where additional stimulation is not explicitly precluded from occurring, still reads on the recited claim language, as long as a portion of the stimulation therapy provides stimulation at the claimed parameters. In other words, if additional stimulation doses are applied, it could fall outside the claimed stimulation protocol, and simply be another stimulation protocol applied as part of the method. An updated grounds of rejection is presented below, after further search and consideration of the art, necessitated by amendment. The examiner notes that the newly cited secondary references further obviate the claimed parameters as expounded below.
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 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 applications: Application Nos. 17/471,962, 17/491, 313, 16/838,953, 16/229,299, 62/609,807, all fail 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, the prior disclosures fail to discuss electrically stimulating the vagus nerve to inhibit the reduction of telomere lengths as claimed. Accordingly, the present invention is awarded the effective filing date of 28 April 2022.
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.
Claims 1, 3-10, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US 2011/0319958; 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 Chu et al. (US 2019/0232047; hereinafter “Chu”)
Regarding claim 1, Simon teaches a method for stimulating a patient, the method comprising: positioning an electrode of a device in contact with an outer skin surface of a neck of a patient (e.g. ¶¶ 13, 45, 19, 96, etc.); applying, via the device, when the electrode is in contact with the outer skin surface of the patient, an electric current transcutaneously from the device through the outer skin surface of the patient to a vagus nerve in the patient (e.g. ¶¶ 13, 45, 19, 96, etc.) according to a stimulation protocol that includes applying the electrical impulse as a stimulation dose having a duration of about 90 seconds to about 3 minutes (e.g. ¶¶ 166 – “entire treatment period – 90 seconds in an embodiment”; ¶¶ 169, etc.).
Simon fails to expressly disclose an electrical impulse as a first and second dose, wherein the second dose is applied five minutes or less after the first single dose and where the doses are administered each day for a plurality of days. 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 once or 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 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, applied 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)).
Simon fails to expressly disclose that the electric current and stimulation protocol are sufficient to modulate the vagus nerve to increase an activity of telomerase and at least inhibit a reduction in telomere length in the patient. In the same field of endeavor, Chu discloses the use of vagal nerve stimulation to modulate the vagus nerve sufficiently to inhibit a reduction in telomere length in the patient and increase an activity of telomerase within the patient in order to effectively measure the efficacy of anxiety treatment (e.g. ¶¶ 564). 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 stimulating the vagus nerve to inhibit a reduction in telomere lengths, as taught by Chu, to improve the similar device of Simon ready for improvement, to yield the predictable results of ensuring that the appropriate level of stimulation has been performed to treat a plurality of other disorders including anxiety by increasing telomerase activity.
Regarding claims 3-4, Simon fails to expressly disclose the electrical impulse and the stimulation protocol are sufficient to modulate the vagus nerve to reduce a cortisol level within the patient and an amount of circulating cortisol within the patient. The examiner notes that the present application’s disclosure does not appear to offer any specific stimulation parameters are focus as to how the stimulation applied reduce a cortisol level within the patient and an amount of circulating cortisol within the patient would differ from any of the other viruses and medical disorders listed throughout the disclosure (e.g. ¶¶ 249 – Parkinson’s). Additionally, the claims require no specific stimulation parameters other than the dosage which is anticipated by Simon’s disclosure. Simon also indicates treating a plurality of different medical conditions including different viruses causing inflammation (e.g. ¶¶ 6 – Parkinson’s). Accordingly, the examiner is of the position that it would have been obvious to apply the method of treating a medical disorder as taught by Simon, to reduce a cortisol level within the patient and an amount of circulating cortisol within the patient, 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 be hepatitis or reduce a cortisol level within the patient and an amount of circulating cortisol within the patient.
Regarding claim 5, Simon teaches the electrical impulse and the stimulation protocol are sufficient to increase a healthspan of the patient (e.g. ¶¶ 105 – improvement of heart rate and heart function).
Regarding claim 6, Simon teaches attaching one or more electrodes to the outer skin surface of a neck of the patient (e.g. ¶¶ 45-52, 68, etc.).
Regarding claim 7, Simon teaches the electrodes are coupled to an energy source via one or more leads (e.g. ¶¶ 52).
Regarding claim 8, Simon teaches wirelessly transmitting the electrical impulse to the one or more electrodes (e.g. ¶¶ 48 – “leadless impulses as shown in the art may be utilized for applying impulses to the target regions.”).
Regarding claim 9, Simon teaches the electrodes are part of a housing and wherein the energy source is housed within the housing (e.g. Fig. 1, #320).
Regarding claim 10, Simon teaches attaching a patch to the outer skin surface of a neck of the patient, wherein the patch comprises one or more electrodes (e.g. ¶¶ 45-52, 68, etc.).
Regarding claim 12, Simon teaches the stimulation protocol comprises 2 to 12 treatments/day (e.g. ¶¶ ¶¶ 86 – “this sequence was performed for 5 cycles in each subject.”)
Regarding claim 13, Simon teaches the electrical impulse comprises pulses having a frequency of about 1 kHz to about 20 kHz (e.g. ¶¶ 15).
Regarding claim 14, Simon teaches the electrical impulse comprises bursts of pulses, with each burst having a frequency of about 1 to about 100 bursts per second and each pulse has a duration of about 50 to about 1000 microseconds in duration (e.g. ¶¶ 45-47, 100, 114-116, etc.).
Regarding claim 15, Simon teaches the bursts each comprise about 2 to 20 pulses and the bursts are separated by an inter-burst period that comprises zero pulses (e.g. ¶¶ 45-47, 100, 114-116, etc.).
Regarding claim 16, Simon teaches the electrical impulse is sufficient to inhibit systemic inflammation within the patient (e.g. ¶¶ 119).
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 extension fee 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 date of this final action.
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