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 21-27 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 21, it cannot be determined what elements are being positively recited/claimed and what elements are meant as intended use/functional limitations. In the claim it is unclear if the signal generator, electrodes, and heart rate sensor are being positively recited/claimed or are meant as intended use/functional limitations. It is suggested to first positively recite the elements before they are used in connections. A suggested claim format would be:
“A vagus nerve stimulation system for stimulating a vagus nerve in a biological subject, the system comprising:
electrodes;
a signal generator connected to the electrodes and configured to generate at least one therapy signal adapted to be applied to the vagus nerve within a tragus by the electrodes, to thereby modulate the vagus nerve;
a heart rate sensor to monitor a heart rate; and
a controller configured to control the signal generator to generate the therapy signal and configured to determine heart rate variability from the monitored heart rate, the controller generating a predictive indicator in accordance with the heart rate variability indicative of a responsiveness to the at least one therapy signal”.
In claim 21, line 4, “that is applied to the vague nerve…electrodes” is vague, sounds more like a method step than a structural limitation, and it is unclear if this is claiming a connection to the body. Apparatus claims cannot claim a connection to the body. It is suggested to use functional language such as “adapted to be applied…”. In line 6, “configured to use a heart rate variability from heart rate sensors by monitoring a heart rate” is vague as some other element must calculate/determine heart rate variability (hrv) from the heart rate. In the last line, “therapy signals” is vague as it is unclear if this is referencing the “at least one therapy signal” of line 4, or are additional therapy signals from some other element. If they are the same then it is suggested to use “to the at least one therapy signal”.
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.
In claim 24, “a hook extending over and behind the ear” is vague, sounds more like a method step, and sounds like there is a connection to the body. It is suggested to state “a hook configured to extend over…”.
In claim 25, “the lead” lacks antecedent basis.
In claim 26, line 1, “to any one of the claim 23” seems to be misworded. It is suggested to use “according to 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 21-22 are rejected under 35 U.S.C. 102a2 as being anticipated by Po et al (11357972).
Due to the vague language and unclear recitation of the elements, the examiner is unclear what elements are being positively recited/claimed, or are meant as an intended use/functional limitation. As best understood by the examiner, Po meets the claimed limitations as follows:
--clip with electrodes to stimulate the tragus and vagus nerve (e.g. abstract, col. 12, lines 56-67; claim 7; col. 19, lines 27, etc.)
--signal generator to generate the at least one therapy signal to the vagus nerve/tragus (e.g. figure 2, element 220; figure 1, with lead going to ear stimulators 102; col. 12, lines 56-67, etc.)
--heart rate sensors to measure heart rate and determine HRV (e.g. figure 2, element 212; col. 15, lines 40-62
--a controller to control the signal generator based on the monitored HRV (e.g. figure 2, element 204 in combination with element 224/230, col. 9, line 55 to col. 10, line 35; col. 15, line 40 to col. 16, line 60, etc.)
--and generate a predictive “indicator” indictive of a responsiveness to therapy signals. Note that the claim only states it is an “indicator” and it is “indicative of a responsiveness to therapy signals”. Po uses a closed loop feedback system to automatically adjust the stimulation (e.g. col. 5, lines 65-67, etc.) where the HRV is compared with a threshold to know when to start/deliver stimulation or not deliver stimulation (e.g. col. 16, line 65 to col. 17, line 19; col. 2, lines 24-37; claim 11, last five paragraphs of the claim, etc.). The claimed “indicator” is the result/output of the comparison of the HRV to the threshold, or the actual signal used for starting of the therapy, stopping of the therapy, or continued use of the therapy. This indicator predicts and/or indicates responsiveness of the therapy as it indicates the therapy will work to reduce atrial fibrillation, that therapy has worked and is no longer needed, or that the therapy needs to be further applied. In addition, it is an indicator because it predicts that atrial fibrillation is about to start and indicates that therapy is called for and should reduce the chance of atrial fibrillation (e.g. col. 2, lines 24-37, etc.). The alert to a person also can be considered an indicator indicative of a responsiveness to therapy signals for the same reasons discussed above.
For claim 26, this indicator is also indicative of a responsiveness to atrial fibrillation therapy as Po also supplies AF therapy and measures the resulting HRV compared to the threshold (e.g. col. 2, lines 24-37, etc.)
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 Po et al in view of Honeycutt et al (2020/0338348). Po discloses a lead from the ear clip (e.g. figure 1, wires leaving element 102 to element 106; clip at col. 19, lines 25-27, etc.)) 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. Po 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 Po, 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.
Conclusion
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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/George R Evanisko/Primary Examiner, Art Unit 3792 12/4/25