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 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.
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 No. 12/859,568, 12/964,050, 13/005,005, 13/075,746, 13/109,250, 13/183,721, 13/183,765, and 13/222,087, 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 examiner is unable to find support for the specific 2.5-7.5 Khz stimulation frequency presently recited in the claims. The earliest prior filed application where support was found is Application No. 13/858,114; accordingly, the present application and claim set is awarded a priority date of March 3, 2013.
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, 9-19, and 25-29 are rejected under 35 U.S.C. 103 as being unpatentable over De Ridder et al. (US 2006/0095088, hereinafter “Ridder”) in view of Zabara et al. (USP# 6,721,603; hereinafter “Zabara”), further in view of Errico et al. (US 2009/0187231; hereinafter “Errico”).
Regarding claims 1 and 17, Ridder teaches a method of treating a patient exhibiting an inflammatory response (e.g. ¶¶ 17-18, 41, etc.), the method comprising:
positioning a housing in contact with an outer skin surface of the patient, generating an electric current within the housing and 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 (e.g. ¶¶ 77) at or near a vagus nerve within the patient (e.g. ¶¶ 68, 93, etc.); and wherein the electrical impulse comprises a burst of pulses, wherein each pulse has a frequency of about 1 kHz (e.g. ¶¶ 81 – “Each spike can comprise a frequency in the range of about 50 Hz to about 1000 Hz”) and each burst has a frequency of about 10-100 Hz (e.g. ¶¶ 81 – “12 Hz for each burst”); and is sufficient to generate an action potential in the vagus nerve and inhibit an inflammatory response in the patient (e.g. ¶¶ 139-140).
It is unclear whether Ridder discloses positioning the electrodes of a housing in contact with the outer surface of the patient, where the current is transmitted from the electrodes through the outer skin. Ridder does disclose that the vagus nerve can be stimulated in an alternate manner, using a transcutaneous nerve stimulator; however, it is unclear whether this transcutaneous nerve stimulator requires positioning the electrodes on the skin as claimed. In the same field of endeavor, Zabara specifies applying one or more electrodes of a housing in contact with an outer surface the skin and transmitting the electrical current transcutaneously and non invasively in order to reduce pain in the patient (e.g. Col 2, ll 8-13). 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 positioning electrodes of the housing in contact with an outer skin surface of the patient for transcutaneous electrode stimulation as taught by Zabara, to the device of Ridder, in order to improve the device in by avoiding any additional components required or potential complications during RF/wireless transmission through the skin.
Ridder discloses the electrical impulse comprises a burst of pulses where each burst has a frequency of about 10-100 Hz (e.g. ¶¶ 81 – “12 Hz for each burst”) and pulse frequency of about 1 kHz (e.g. ¶¶ 81 – “Each spike can comprise a frequency in the range of about 50 Hz to about 1000 Hz”), but fails to expressly disclose each pulse having a stimulation frequency of 2.5 – 7.5 kHz. In the same filed of endeavor, Errico teaches stimulation to treat inflammation up to 3kHz, falling within the claimed 2.5-7.5 kHz parameters (e.g. ¶¶ 104). It would have been an obvious design choice to one of ordinary skill in the art, prior to the effective filing date, to use the known technique of applying stimulation with a frequency between 2.5-7.5kHz as taught by Errico, to the known device of Ridder, in order to offer an improved therapeutic benefit to patient physiology responsive at a higher frequency.
Regarding claims 2-3 and 18-19, Ridder teaches/discloses the electrical impulse is to inhibit release of a pro-inflammatory cytokine – specifically TNF alpha (e.g. ¶¶ 119.).
Regarding claims 13, and 24, Ridder further comprises transmitting the electric current transcutaneously and non-invasively from the contact surface through the outer skin surface of the patient – in the neck region, such that the electrical impulse is generated at or near the vagus nerve (e.g. ¶¶ 81).
Regarding claims 9-12, 14-16, and 25-29, Ridder indicates an electrical pulse comprising bursts of 2-20 pulses, at 5-100 Hz, with a duration of approximately 200 microseconds, applied 2-5 times a day, with a single dosage between 1-3 minutes (e.g. ¶¶ 81).
Claims 4-5 and 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Ridder in view of Zabara, further in view of Errico, as applied to claim 1 above, further in view of Simon (US 2011/0152967). Ridder fails to expressly disclose the electrical impulse is sufficient to increase an anti-inflammatory competence of a cytokine including a tumor growth factor (TGF) – beta. In the same field of endeavor, Simon discloses electrical vagal stimulation in order to increase anti-inflammatory competence of cytokines including TGF (e.g. ¶¶ 37). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to improve the device of Ridder in the same manner as taught by Simon, by applying stimulation with the purpose of increasing anti-inflammatory competence of a cytokine including TGF, in order to yield the predictable results of providing inflammatory relief through multiple biological pathways.
Allowable Subject Matter
Claims 6-7 and 22-23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Applicant's amendment dated 27 July 2025, in response to the Non Final Office Action dated 1 April 2025, necessitates 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