DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 April 16, 2026 has been entered. Currently claims 1-20 are pending in this application with claims 1-11 are withdrawn from consideration.
Response to Arguments
Applicant's arguments filed April 16, 2026 have been fully considered as follows:
Double Patenting Rejection
Due to the amendments to the claims, the double patenting rejection has been withdrawn.
35 U.S.C. 112 rejection of claim 12 - “autonomic body signals”
Examiner has further considered the term “autonomic body signal” and has taken the broadest reasonable interpretation of the term to include all involuntary physiological responses as suggested by Applicant on Page 2 of the response filed May 17, 2026. The rejection under 35 U.S.C. 112, second paragraph has been withdrawn.
35 U.S.C. 112 rejection of claim 13 – “increasing or decreasing sympathetic tone via the electrode coupled to the vagus nerve”
Examiner has further considered Applicant’s arguments with respect to the rejection claim 13 under 35 U.S.C. 112, second paragraph are persuasive. While the specification discloses stimulating the vagus nerve, which is a parasympathetic nerve, it is known in art that such parasympathetic stimulation can affect sympathetic tone and sympathetic/parasympathetic tone balance.
35 U.S.C. 102 rejection of claims 12 and 15-16 under Ben David
Applicant’s arguments regarding the rejection under 35 U.S.C. 102 have been considered and are persuasive inasmuch as they apply to the amended claims. The rejection has been withdrawn. Examiner notes the new rejections under 35 U.S.C. 103 disclosed below.
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 12-20 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.
Claim 12 recites the phrase “configured via one or more processors to compare a monitored value which is determined based on one or more data points relating to the heart rate and the autonomic body signals to one or more threshold values.”
This phrase is unclear. Since only one data point is required to determine the monitored value, using the broadest reasonable interpretation of the claim, the data point could be the heart rate, as a single heart rate value can be considered “one data point relating to the heart rate and the autonomic body signals.” The claims as currently filed do not require the monitored value to based on data points related to BOTH heart rate and the autonomic signal, but rather only one data point.
Additionally, even if data points from both the heart rate and the autonomic body signal are required to determine the monitored value, it is not clear if the data points used to determine the monitored value are 1) the heart rate and 2) the autonomic body signal or if the data points are some other data points “related” to those values. Since the metes and bounds of the term “related to” are not clearly defined in the specification, it is unclear how the how the “monitored value” is calculated.
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 (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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 12-20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over
Libbus (US 2006/0253161) in view of Williams (US 2007/0255379).
Regarding claim 12, as best the claim can be understood, Libbus discloses a system for treating a medical condition in a patient, comprising:
a sensor for sensing at least one body data stream (e.g. sensors 990 as shown in Figure 9);
at least one electrode coupled to a vagus nerve of the patient (e.g. electrodes attached to neural leads 903 as shown in Figure 9, including electrode 109 that is coupled to nerve 104 of the which can include the parasympathetic vagus nerve as disclosed in [0029]);
a programmable electrical signal generator (e.g. neural stimulation circuit 930 located in device 910 as shown in Figure 9);
a unit capable of determining a heart rate and autonomic body signals of the patient based on the at least one body data stream (e.g. autonomic balance monitoring circuit 534 which includes physiologic function circuit 554 (854) which can determine a heart rate using heart rate sensing circuit 862 and any one of: respiration sensing circuit 866, impedance sensing circuit 868, heart sound sensing circuit 870, and pressure sensing 872, all of which can be considered autonomic body signals as shown in Figure 8 as well as nerve traffic sensing circuit 550 and surrogate signal sensing circuit 554 which are also both autonomic body signals); and
a logic unit configured via one or more processors to compare a monitored value which is determined based on one or more data points relating to the heart rate to one or more threshold values (e.g. comparison of heart rate threshold as taught in [0038]).
the logic unit further configured to determine a triggering event based on the comparison (e.g. determining triggering event based on the comparison above);
wherein the one or more processors are configured to initiate one or more actions to change the heart rate of the patient based on the determination of the triggering event (e.g. sympathetic/parasympathetic stimulation adjustment as disclosed in [0038]).
Alternatively, Libbus does not expressly disclose a processor that compares a monitored value which is determined based on one or more data points relating to both the heart rate and the autonomic body signals to one or more threshold values. Libbus does, however, disclose using physiological function circuit data as well as the nerve traffic and surrogate signal sensing circuit data to control delivery of neural stimulation based on feedback control (e.g. as shown in Figure 17). It would have been obvious to one having ordinary skill in the art to use the heart rate and autonomic body signal data of Libbus and compare it to a threshold in order to determine when appropriate stimulation is required, since such a modification would provide the system with the predictable results of a reliable means of balancing sympathetic and parasympathetic signals.
Libbus does not disclose wherein the one or more processors are configured to determine an epileptic seizure status. Williams discloses that it was well known in the art of nervous system stimulators to determine a seizure status (e.g. device 12 includes detection of seizures as described in [0030]). It would have been obvious to one having ordinary skill in the art to include the seizure detector of Williams in the device of Libbus in order to provide the system with the predictable results of a reliable means of determining seizure status in order to provide the correct stimulation.
Examiner notes that the claims as currently written do not require the seizure status to be determined from any of the previously collected data. If Applicant wishes to tie the heart rate and/or autonomic body signal data comparison to a threshold to detecting the seizure event, such limitations should be included in the claims.
Regarding claims 14-20, Libbus additionally discloses increasing sympathetic tone and/or decreasing parasympathetic tone to increase the patient’s heart rate based on a triggering event and to decrease sympathetic tone and/or increase parasympathetic tone to decrease a patient’s heart rate based on a triggering event (e.g. increase/decrease as disclosed in [0038], wherein the control unit work in an iterative feedback fashion, and will thus necessarily receive a second, third, and fourth triggering event).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached on 571-272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Amanda K Hulbert/ Primary Examiner, Art Unit 3792
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