DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
Applicant’s amendment dated September 24,2026 is acknowledged. Currently claims 1-10, 12-13, and 15-17 are pending in this application, with claims 1-9 withdrawn from consideration.
Response to Arguments
Applicant’s arguments regarding the rejections under 35 U.S.C. 102 have been considered but are not persuasive.
Applicant argues that Libbus does not disclose a logic unit configured via one or more processors to compare a monitored value with is determined based on one or more data points relating the heart rate to one or more threshold values. Examiner disagrees. Libbus discloses a logic unit (e.g. stimulation control circuit 336 as previously cited in Figure 3 which is further broken down in Figure 4, including a stimulation parameter adjustment circuit 444 which adjust parameters based on a heart rate threshold as disclosed in [0038]). The heart rate threshold values used in Libbus can be considered “a monitored value which is determined based on one or more data points relating the heart rate to one or more threshold values” and thus fulfills the limitations of the claims.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 10, 12, 13, 15-17 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Libbus (US 2006/0253161).
Regarding claim 10, Libbus teaches 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 (e.g. electrodes attached to neural leads 903 as shown in Figure 9);
a programmable electrical signal generator (e.g. implantable medical device 910);
a heart rate unit capable of determining a heart rate of the patient based on the at least one body data stream (e.g. heart rate sensing circuit 862); 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, the logic unit further configured to determine a first triggering event based on the comparison (e.g. stimulation control circuit 336);
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 first triggering event; the one or more processors are configured to via the at least one electrode increase a sympathetic tone or to decrease a parasympathetic tone to increase the heart rate of the patient based on the first triggering event via the programmable electrical signal generator (e.g. adjustment of sympathetic stimulation controller 338 based upon the patient’s heart rate as disclosed in [0038])..
Regarding claim 12, Libbus additionally discloses wherein the logic unit is further configured to determine a second triggering event based on the comparison (e.g. the stimulation control unit as disclosed in 336 and 436 work in an iterative fashion, and will thus necessarily receive a second triggering event).
Regarding claim 13, Libbus additionally discloses wherein the one or more processors are configured to decrease a sympathetic tone to decrease the heart rate of the patient based on the second triggering event via the programmable electrical signal generator (e.g. decreasing sympathetic when a heart rate exceeds a predetermined threshold as disclosed in [0038]).
Regarding claim 15, Libbus additionally discloses wherein the one or more processors are configured to decrease the parasympathetic tone to increase the heart rate of the patient based on the third triggering event via the programmable electrical signal generator (e.g. decreasing the parasympathetic tone to increase the heart rate when the heart rate falls below a predetermined threshold as taught in [0038]).
Regarding claim 16, Libbus additionally discloses wherein the logic unit is further configured to determine an Nth triggering event based on the comparison (e.g. the stimulation control unit as disclosed in 336 and 436 work in an iterative fashion, and will thus necessarily receive a Nth triggering event).
Regarding claim 17, Libbus additionally discloses wherein the one or more processors are configured to increase the sympathetic tone to increase the heart rate of the patient based on the Nth triggering event via the programmable electrical signal generator (e.g. increase of sympathetic tone to increase heart rate as disclosed in [0038], wherein the stimulation control unit as disclosed in 336 and 436 work in an iterative fashion, and will thus necessarily receive a Nth triggering event).
Conclusion
THIS ACTION IS MADE FINAL. 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 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 at 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
