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 Arguments
Applicant’s arguments regarding the rejections under 35 U.S.C. 112 have been considered and are persuasive. Examiner notes that the broadest reasonable interpretation of the claims do not require the sympathetic tone to be increased or decreased specifically with stimulation of the vagus nerve, and the specification finds support for sympathetic tone stimulation in paragraph 177, "the method may comprise reducing the patient's sympathetic tone, such as by applying high-frequency stimulation to a sympathetic nerve trunk or ganglion or administering an anti-cholinergic drug." Therefore, the rejections have been withdrawn.
However, upon further search and consideration, a new ground(s) of rejection is made in view of Libbus et al. (US 2006/0253161).
This action is NON-FINAL.
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 sympathetic 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
Due to the new rejections that were not necessitated by amendment, this action is NON-FINAL.
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
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