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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 23-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 23, line 6, “electrodes” is vague as this term is also used in claim 21, line 3, and it is unclear if the electrodes from claim 23 are the same as from claim 21. If they are the same, then “the electrodes” should be used in claim 23.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 21-23 and 26-27 are rejected under 35 U.S.C. 102a2 as being anticipated by Ackland et al (2023/0355972). Ackland has priority and support back 7/24/2020, before the effective filing date of 8/12/20 of this application, and meets the claimed limitations as follows:
--clip with electrodes to stimulate the tragus and vagus nerve (e.g. paras. 67, 40, etc.)
--signal generator to generate the at least one therapy signal to the vagus nerve/tragus (e.g. figure 2, element 4/10, paras. 90-94, etc.)
--heart rate sensors to measure heart rate and determine HRV (e.g. figure 2, element 17; paras. 48, 98, etc.)
--a controller to control the signal generator to deliver the stimulation (e.g. paras. 13, 62, etc.) and determine HRV using a LF/HF ratio (e.g. paras. 48-49, 87, etc.) that generates a predictive indicator or responsiveness to the therapy (e.g. para. 48, greater than a threshold value, etc.).
For claim: 22, Po discloses the use for atrial fibrillation (e.g. paras. 90, 95, etc.); 23: opposing biased arms with electrodes (paras. 21, 22, 40, in the alternative, see the 103 rejection below); 26, a lead with connections (e.g. figure 1b, para. 61, etc.); and 27, shows the lead extend laterally from the clip and is capable of looping over and behind the ear due to the leads length (e.g. figure 1b, in the alternative, see the 103 rejection below).
Claim Rejections - 35 USC § 103
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, 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.
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 23-27 are rejected under 35 U.S.C. 103 as being unpatentable over Ackland et al in view of Honeycutt et al (2020/0338348).
Ackland discloses a lead from the ear clip with biased arms to the signal generator to deliver therapy and therefore has electrical connections between the two (e.g. claim 26), and as seen in the figure, the lead can be looped behind an ear due to its length. Ackland does not disclose the clip having opposing arms biased toward each other with electrodes on the distal arm ends with opposing faces urged into engagement with opposing faces of the tragus (claim 23), a hook extending over and behind the ear (claim 24) or laterally from the clip (claim 25), and the lead extend laterally from the clip or from a distal end of one of the arms (claim 27). Honeycutt discloses a clip having opposing arms biased toward each other with electrodes on the distal arm ends with opposing faces urged into engagement with opposing faces of the tragus (e.g. figure 5A, 5B, paras. 127-128, etc., capable of being placed on the tragus), a hook extending over and behind the ear (figure 6A, element 162, figure 6B, etc.) or laterally from the clip (figures 6A, 6B etc.), and the lead extend laterally from the clip or from a distal end of one of the arms (e.g. figures 5B, or 6B, note in figure 6B that the hook can be considered the lead also as it provides power/stimulation to the electrodes), all to provide a way to securely attach the electrodes to the patient’s ear to provide therapy, to hold the clip and leads on the patient, and prevent entanglement of wires. It would have been obvious to one having ordinary skill in the art at the time the invention was made/before it was effectively filed to have modified the system and method as taught by Ackland, with the clip having opposing arms biased toward each other with electrodes on the distal arm ends with opposing faces urged into engagement with opposing faces of the tragus, a hook extending over and behind the ear or laterally from the clip, and the lead extend laterally from the clip or from a distal end of one of the arms, as taught by Honeycutt, since it would provide the predictable results of providing a way to securely attach the electrodes to the patient’s ear to provide therapy, and holding the clip and leads on the patient and preventing entanglement of wires/leads and components.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot in view of the new grounds of rejection necessitated by amendment. The prior art of Po shows another use of HRV and the NPL of Stavrakis shows the use of LF/HF ratio for AF using a clip.
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 George Robert Evanisko whose telephone number is (571)272-4945. The examiner can normally be reached M-F 8AM-5PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/George R Evanisko/Primary Examiner, Art Unit 3792 7/9/26
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