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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 12/5/23 has/have been acknowledged and is/are being considered by the Examiner.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-7 and 11-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by An et al. (U.S. Pub. 2019/0275338 hereinafter “An”).
Regarding claim 1, An discloses a medical device system, comprising: a stimulation circuit (e.g 240) configured to generate first and second stimulation signals in different respective first and second stimulation modes, the first and second stimulation signals configured to be provided to a heart of a patient (e.g. Figs. 6-8); a signal receiver circuit (e.g. 210) configured to receive physiologic information of the patient, including at least one of thoracic impedance information or respiration information(e.g. ¶¶47, 67); and an assessment circuit (e.g. 230) configured to control transition of the stimulation circuit between the first and second stimulation modes, including to: determine a patient metric using the received physiologic information from a first time period (e.g. ¶¶64, 69 and 97); and control transition of the stimulation circuit between the first stimulation mode and the second stimulation mode based on the determined patient metric (e.g. ¶¶69, 97; Claim 9).
Regarding claim 2, An further discloses wherein the first time period occurs while the stimulation circuit is in the first stimulation mode, and wherein to control transition between the first and second stimulation modes comprises to control transition from the first stimulation mode to the second stimulation mode based on the determined patient metric (e.g. ¶64; Claim 9).
Regarding claim 3, An further discloses wherein the assessment circuit is configured to control implementation of the first stimulation mode at a first time, wherein the first time period occurs after the first time, and wherein to control transition of the stimulation circuit from the first stimulation mode to the second stimulation mode comprises at a second time after the first time period (e.g. ¶¶77-79; Claims 5-6).
Regarding claim 4, An further discloses wherein to control transition of the stimulation circuit from the first stimulation mode to the second stimulation mode at the second time comprises to: compare the determined patient metric to a threshold (e.g. ¶70); transition the stimulation circuit from the first stimulation mode to the second stimulation mode if the determined patient metric exceeds a first threshold (e.g. ¶70); and retain the stimulation circuit in the first stimulation mode if the determined patient metric does not exceed the first threshold (e.g. ¶70).
Regarding claim 4, An further discloses wherein the first stimulation mode comprises a cardiac resynchronization therapy (CRT) mode configured to generate stimulation signals to be delivered to at least one of a single electrode in a first chamber of the heart or a single electrode in a second chamber of the heart (e.g. Claim 9), and wherein the second stimulation mode comprises a multi-site pacing (MSP) mode configured to generate stimulation signals to be delivered to multiple electrodes in one of the first or second chambers of the heart (e.g. Claim 9).
Regarding claim 6, An further discloses wherein the CRT mode is configured to generate biventricular pacing signals to be delivered to a single electrode in each of a right and a left ventricle of the heart (e.g. ¶95), and wherein the MSP therapy mode is configured to generate stimulation signals to be delivered to multiple electrodes in the left ventricle of the heart (e.g. ¶95).
Regarding claim 7, An further discloses wherein the first time period occurs while the stimulation circuit is in the second stimulation mode, and wherein to control transition between the first and second stimulation modes comprises to control transition from the second stimulation mode to the first stimulation mode based on the determined patient metric (e.g. Claims 6-8).
Regarding claim 11, An discloses a method comprising: generating, using a stimulation circuit (e.g. 240), first and second stimulation signals in different respective first and second stimulation modes, the first and second stimulation signals configured to be provided to a heart of a patient (e.g. Figs. 6-8); receiving, using a signal receiver circuit (e.g. 210), physiologic information of the patient, including at least one of thoracic impedance information or respiration information (e.g. ¶¶47, 67); and controlling, using an assessment circuit (e.g. 230), transition of the stimulation circuit between the first and second stimulation modes, including :determining a patient metric using the received physiologic information from a first time period (e.g. ¶¶64, 69 and 97); and controlling transition of the stimulation circuit between the first stimulation mode and the second stimulation mode based on the determined patient metric (e.g. ¶¶69 and 97; Claim 9).
Regarding claim 12, An further discloses wherein the first time period occurs while the stimulation circuit is in the first stimulation mode, and wherein controlling transition between the first and second stimulation modes comprises controlling transition from the first stimulation mode to the second stimulation mode based on the determined patient metric (e.g. ¶64; Claim 9).
Regarding claim 13, An further discloses controlling control implementation of the first stimulation mode at a first time, wherein the first time period occurs after the first time, wherein controlling transition of the stimulation circuit from the first stimulation mode to the second stimulation mode comprises at a second time after the first time period (e.g. ¶¶77-79; Claims 5-6).
Regarding claim 14, An further discloses wherein controlling transition of the stimulation circuit from the first stimulation mode to the second stimulation mode at the second time comprises: comparing the determined patient metric to a threshold (e.g. ¶70); transitioning the stimulation circuit from the first stimulation mode to the second stimulation mode if the determined patient metric exceeds a first threshold (e.g. ¶70); and retaining the stimulation circuit in the first stimulation mode if the determined patient metric does not exceed the first threshold (e.g. ¶70).
Regarding claim 15, An further discloses wherein the first stimulation mode comprises a cardiac resynchronization therapy (CRT) mode configured to generate stimulation signals to be delivered to at least one of a single electrode in a first chamber of the heart or a single electrode in a second chamber of the heart (e.g. Claim 9), and wherein the second stimulation mode comprises a multi-site pacing (MSP) mode configured to generate stimulation signals to be delivered to multiple electrodes in one of the first or second chambers of the heart (e.g. Claim 9).
Regarding claim 16, An further discloses wherein the CRT mode is configured to generate biventricular pacing signals to be delivered to a single electrode in each of a right and a left ventricle of the heart (e.g. ¶95), and wherein the MSP therapy mode is configured to generate stimulation signals to be delivered to multiple electrodes in the left ventricle of the heart (e.g. ¶95).
Regarding claim 17, An further discloses wherein the first time period occurs while the stimulation circuit is in the second stimulation mode, and wherein controlling transition between the first and second stimulation modes comprises controlling transition from the second stimulation mode to the first stimulation mode based on the determined patient metric (e.g. Claims 6-8).
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.
Claim(s) 8-10 and 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over An as applied to claims 1-7 and 11-17 above, and further in view of Thakur et al. (U.S. Pub. 2019/0083789 hereinafter “Thakur”).
Regarding claims 8-10 and 18-20, An discloses the claimed invention including the intrathoracic impedance and respiratory sensing but fails to explicitly state that the respiratory information is rapid slow breathing index or tidal volume. However, Thakur teaches that it is known to use rapid slow breathing index or tidal volume as set forth in Paragraphs 53, 66 and 78 to provide known metrics that are used to detect and treat heart failure. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by An, with the use of respiratory information is rapid slow breathing index or tidal volume as taught by Thakur, since such a modification would provide the predictable results of using known sensed metrics to provide for the detection and treatment of heart failure.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REX R HOLMES whose telephone number is (571)272-8827. The examiner can normally be reached Monday-Thursday 7:00AM-5:30PM.
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/REX R HOLMES/ Primary Examiner, Art Unit 3796