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 § 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)(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) 1-9, 12-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Demmer (US 20200254262 A1; 8/13/2020).
Regarding claim 1, Demmer teaches a medical device comprising (Fig. 1) :
memory configured to store parameters for a first electrical signal for a patient (Fig. 3; [0044]; [0048]; [0055]);
communication circuitry (Fig. 3; [0057]);
electrical signal generation circuitry (Fig. 3; [0049]); and
processing circuitry communicatively coupled to the memory, the communication circuitry, and the electrical signal generation circuitry (Fig. 3; [0044]), the processing circuitry being configured to:
control the electrical signal generation circuitry to deliver the first electrical signal to an anatomy of the patient ([0047]-[0049]); and
based on the electrical signal generation circuitry delivering the first electrical signal, control the communication circuitry to communicate with another medical device ([0024]; [0033]; [0060]; [0081]; [0109]-[0110]).
Regarding claim 2, Demmer teaches wherein the processing circuitry is further configured to refrain from controlling the communication circuitry to send a wake-up signal to the another medical device ([0024]; [0109]-[0110]; reference is teaching use of heart rate pacing as communications along with feedback to pacemaker as needed and so no wake-up signal is needed; see especially [0118] in which wake-up command is only used with another external device 50 as opposed to communications between pacemaker 14 and HRM 40 of Fig. 1).
Regarding claim 3, Demmer teaches wherein as part of communicating with the another medical device, the communication circuitry is configured to one or more of receive a communication from the another medical device or send a communication to the another medical device (Fig. 1; [0024]; [0033]; [0060]; [0081]; [0109]-[0110]; [0118]).
Regarding claim 4, Demmer teaches further comprising at least one of a sensor or sensing circuitry configured to sense physiological parameters of the patient, wherein the processing circuitry is further configured to determine to control the electrical signal generation circuitry to deliver the first electrical signal based on at least one sensed physiological parameter or a communication from an external device (Fig. 1; [0024]; [0033]; [0037]; [0060]; [0076]; [0081]; [0109]-[0110]; [0118]).
Regarding claim 5, Demmer teaches wherein the at least one sensed physiological parameter is indicative of a cardiac event (Fig. 10; [0076]; [0111]).
Regarding claim 6, Demmer teaches wherein the cardiac event comprises tachycardia ([0076]; [0111]).
Regarding claim 7, Demmer teaches wherein the processing circuitry is further configured to control the communication circuitry to send an instruction to the another medical device (Fig. 1; [0024]; [0033]; [0060]; [0081]; [0109]-[0110]; [0118]).
Regarding claim 8, Demmer teaches wherein the instruction comprises one or more of:
an instruction to begin delivering pacing pulses to a heart of a patient ([0076]; [0077]; [0111] “back-up pacing therapy”);
an instruction to stop delivering pacing pulses to the heart of the patient ([0109] “may be stopped”); or
an instruction comprising configuration information for configuring an operation of the another medical device ([0109]-[0110]).
Regarding claim 9, Demmer teaches wherein the first electrical signal comprises one or more pacing pulses ([0048]-[0049]; [0076]-[0077]; [0109]-[0111]).
Regarding claim 12, Demmer teaches a medical device comprising:
memory configured to store parameters indicative of delivery of a first electrical signal to an anatomy of a patient (Fig. 3-4; [0044]; [0048]; [0055]; [0060]);
communication circuitry (Fig. 3-4; [0057]; [0060]);
at least one of a sensor or sensing circuitry (Fig. 3-4); and
processing circuitry communicatively coupled to the memory, the communication circuitry, and the at least one of the sensor or the sensing circuitry (Fig. 3-4; [0044]; [0060), the processing circuitry being configured to:
receive from the at least one of the sensor or the sensing circuitry a signal (Fig. 1; [0024]; [0033]; [0037]; [0060]; [0076]; [0081]; [0109]-[0110]; [0118]);
determine that the signal is indicative of the delivery of the first electrical signal by another medical device to the anatomy of the patient (Fig. 1; Fig. 4; [0024]; [0033]; [0037]; [0060]; [0076]; [0081]; [0109]-[0110]; [0118]); and
based on receiving the signal indicative of the delivery of the first electrical signal, control the communication circuitry to initiate communication with at least one of the another medical device or a third medical device (Fig. 1; [0024]; [0033]; [0060]; [0081]; [0109]-[0110]; [0118]).
Regarding claim 13, Demmer teaches wherein as part of controlling the communication circuitry to initiate communication with the another medical device, the processing circuitry is configured to control the communication circuitry to send one or more of a communication to at least one of the another medical device or the third medical device or control the communication circuitry to poll a communication channel (Fig. 1; [0024]; [0033]; [0060]; [0081]; [0109]-[0110]; [0118]).
Regarding claim 14, Demmer teaches wherein the processing circuitry is further configured to:
receive an instruction from the another medical device via the communication circuitry (Fig. 1; [0024]; [0033]; [0060]; [0081]; [0109]-[0110]; [0118]).;
and respond to the instruction (Fig. 1; [0024]; [0033]; [0060]; [0081]; [0109]-[0110]; [0118]).
Regarding claim 15, Demmer teaches further comprising electrical signal generation circuitry (Fig. 3; [0047]-[0049]; [0060]; [0109]) and wherein as part of responding to the instruction, the processing circuitry is configured to control the electrical signal generation circuitry to deliver therapy based on the received instruction ([0060]; [0109]-[0111]).
Regarding claim 16, Demmer teaches wherein the therapy comprises anti-tachyarrhythmia pacing therapy ([0048]-[0049]; [0076]-[0077]; [0109]-[0111]).
Regarding claim 17, Demmer teaches wherein as part of responding to the instruction, the processing circuitry is configured to configure an operation of the medical device based on the received instruction ([0060]; [0076]-[0077]; [0109]-[0111]).
Regarding claim 18, Demmer teaches wherein the medical device comprises a pacemaker ([0060]; [0076]-[0077]; [0109]-[0111]).
Regarding claim 19, Demmer teaches wherein the first electrical signal comprises one or more pacing pulses ([0060]; [0076]-[0077]; [0109]-[0111]).
Regarding claim 20, Demmer teaches a method comprising:
controlling, by processing circuitry, electrical signal generation circuitry to deliver a first electrical signal to an anatomy of a patient (Fig. 3; [0047]-[0049]); and
controlling, by the processing circuitry and based on the electrical signal generation circuitry delivering the first electrical signal, communication circuitry to communicate with another medical device ([0024]; [0033]; [0060]; [0081]; [0109]-[0110]).
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) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demmer as applied to claim 9 above, in view of Demmer (US 20180161580 A1; 6/14/2018), hereinafter Demmer ‘580.
Regarding claim 10, Demmer does not teach wherein the one or more pacing pulses comprise at least one of a subthreshold energy pulse or a double pulse. However, Demmer ‘580 teaches in the same field of endeavor (Abstract; Fig. 3) wherein the one or more pacing pulses comprise at least one of a subthreshold energy pulse or a double pulse ([0110] “double pacing pulse”; [0130]). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Demmer to include this feature as taught by Demmer ‘580 because this enables signaling for particular atrial event ([0110]; [0130]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Demmer as applied to claim 1 above.
Regarding claim 11, Demmer does not explicitly teach wherein the medical device comprises an extracardiovascular defibrillator. However, Demmer does teach “cardioverter/defibrillator or other IMD capable of generating and delivering the electrical stimulation pulses as cardiac pacing pulses intended to capture the myocardium or nerves of the heart.” ([0023]; see also [0037]; [0060]). It would be an obvious rearrangement of parts to have the defibrillator be extracardiovascular as recited since this would achieve the same function of cardiac pacing; MPEP 2144.04.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
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