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 § 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) 7-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ritrivi et al. (US 20180360652) in view of Felix et al. (US 2021/0000418) and Fischell et al. (US 2004/0199212).
With regard to claim 7, and 9, Ritrivi discloses a system and method for treating arrhythmias comprising; an implantable medical device configured to deliver cooling to adjacent tissue, wherein the implantable medical device comprises a Peltier element and a heat sink comprising a phase change material (e.g. paragraph 11, 13, 23).
Ritrivi fails to teach an EKG detection device configured to capture EKG data from a patient, and a hand held patient control module configured to receive communications from the EKG detection device, and in response to a detection of a cardiac arrhythmia based on the EKG data, emit an alert that indicates the cardiac arrhythmia has been detected, wherein the hand held patient control module includes a primary coil configured to transfer power to the implantable medical device by inductively coupling with a secondary coil of the implantable medical device. Ritrivi further fails to explicitly teach in response to the alert, placing the hand held patient control module adjacent to a skin surface of the patient, wherein the cooling device is programmed to activate in response to receiving the power, in response to the cooling device receiving the power.
Felix teaches that it is known to use a hand held patient control module including a primary coil configured to transfer power to the implantable medical device by inductive coupling with a secondary coil of the implantable medical device and includes a rechargeable battery (e.g. paragraph 99-100, powercell 87, Fig. 13). 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 Ritrivi with using an inductive coupling system with a primary external and secondary internal coil for transfer of power to the implantable device and includes a rechargeable battery since Felix teaches that this is known technique for reliable transfer of power to an implantable device. It is of note, the combination with the teachings of Felix uses inductive coupling and as it is known in the art and to one of ordinary skill in the art, inductive coupling would necessarily require bringing the external coil in proximity (adjacent the patient’s skin) to “couple” with the internal coil.
Felix additionally teaches that it is known to send an alert to indicate a particular condition such as an arrhythmia and sensing an arrhythmia condition based on ECG data (e.g. paragraph 17, 46, 71, 60). 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 Ritrivi with an EKG detection device to capture EKG data, a hand held patient control module configured to receive communications from the EKG detection device and in response to a detection of a cardiac arrhythmia based on the EKG data, emit an alert that indicates the cardiac arrhythmia has been detected since such a modification would provide reliable detection of an arrhythmia condition so that a treatment protocol can be delivered in a timely manner.
Fischell teaches a patient alert system for an implanted device with an external device, where the implanted device can detect a serious condition and transmits the alert signal to the external device (e.g. paragraphs 86-87 and 95). Therefore, Fischell generally teaches that it is known to use various combinations of an implanted device and externally coupled device to sense conditions and generate alerts. So, it is the Examiner’s position that it would follow, that 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 Ritrivi with activating the peltier cooling device of Ritrivi in the event of an arrhythmia being detected with a coupled external device, since such a modification would provide the predictable results of terminating the arrhythmia and providing critical care to a patient in need. It is of note that Ritrivi already discloses the use of cooling therapy with a peltier device to treat and mitigate arrhythmias.
Lastly, there is a distinction between the prior art and the claims as written with respect to the implanted device activating in response to receiving the activation signal from the external device in response to the alert. While it is somewhat unclear why one would potentially delay delivery of therapy while waiting for a user to couple the external device to the implanted device, it would still nevertheless be obvious. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the implanted cooling device activate and deliver the cooling therapy in response to coupling the external hand held controller or have the implant preprogrammed with a therapy protocol since there appears to be a finite number of solutions (e.g. either using preprogrammed therapy protocols or transmitting a therapy protocol on demand when an alert condition is detected) and it is obvious to try any of the possible solutions when there is only a finite number of solutions.
Ritrivi in view of Felix and Fischell appear to fail to explicitly teach that the method/system is being performed by a patient who is presently experiencing a cardiac arrhythmia, analyzing the EKG data to determine if the patient is presently experiencing the cardiac arrhythmia, etc. However, Examiner considers the combination of Ritrivi in view of Felix and Fischell to at the very least suggests these steps would be obvious. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Ritrivi in view of Felix and Fischell with treating the patient who is presently experiencing a cardiac arrthythmia, determining whether the patient is presently experiencing the cardiac arrhythmia, in response of the patient becoming aware of the alert that indicates the patient is presently experiencing an arrhythmia, manually placing, by the patient the hand held patient control module…, the hand held patient control module is being held by the patient adjacent to the skin surface of the patient, since such modifications would provide for the most immediate treatment and/or cessation of the arrhythmia. It is clear the combination of Ritrivi in view of Felix and Fischell reasonably teaches use of peltier cooling device to treat arrhythmias. Felix and Fischell are relied upon for teaching that it would have been obvious to detect arrhythmias and generate a patient alert. It would appear to be entirely reasonable that user would want to provide treatment in as close to a real time manner as possible, i.e. while the patient is experiencing the arrhythmia. Additionally, the delivery of treatment must have to be delivered while the patient is experiencing the arrhythmia or else the treatment would be pointless for its intended purpose of treating the arrhythmia. Lastly, due to the combined teachings of Ritrivi in view of Felix and Fischell being configured to use inductively coupled coils for transfer of power, a user must necessarily manually align the coils in order for the coils to couple and transfer power. Therefore, once again, as to the claim limitations directed to a user holding the coil in position while experiencing the arrhythmia, the use must necessarily have to hold the coil in place otherwise the disclosed combined teachings would not be capable of performing the intended purpose of treating and abating the arrhythmia.
With regard to claim 8-9, the combination of Ritrivi in view of Felix as applied above to claim 1, sufficiently teaches the EKG detection device is configured to analyze EKG data to identify the cardiac arrhythmia and in response to identifying the cardiac arrhythmia, transmit an alert to the hand held patent control (e.g. Felix paragraph 60).
With regard to claim 10, the combination of Ritrivi in view of Felix and Fischell fail to teach analyzing by the hand held patient control module and in response to receiving the notification, whether cooling therapy should be delivered to the epicardial tissue of the patient. However, the combination of Ritrivi in view of Felix and Fischell as applied above sufficiently contemplates the interchangeability of analyzing the sensed data at either of the implanted device or the hand held controller. Therefore, 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 Ritrivi, Felix, and Fischell with analyzing by the hand held patient control module and in response to receiving the notification, whether cooling therapy should be delivered to the epicardial tissue of the patient since Felix sufficiently teaches that it is known that analyzing data and determining an alert/therapy condition can be done at the implant or hand held controller.
With regard to claim 11, Ritrivi discloses the invention as claimed but fails to teach the EKG detection device is further configured to transmit at least some of the EKG data to the hand held patient control module in response to identifying the cardiac arrhythmia. Felix teaches that it is known to transmit ECG data to the hand held patient control module in response to identifying the cardiac arrhythmia (e.g. paragraph 60, “For instance, an alert that includes a compressed ECG digitized sample can also be wirelessly transmitted by the ICM 12 upon the triggering of a preset condition, such as an abnormally low heart rate in excess of 170 beats per minute (bpm), an abnormally low heart rate falling below 30 bpm, or AF detected by onboard analysis of RR interval variability by the microcontroller 61.”). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Ritrivi with the EKG detection device is further configured to transmit at least some of the EKG data to the hand held patient control module in response to identifying the cardiac arrhythmia since such a modification would provide the predictable results of ensuring a proper patient history log and allowing for further analysis by medical professionals.
With regard to claim 12, Ritrivi discloses the invention as claimed but fails to teach the hand held patient control module is configured to analyze the EKG data to identify the cardiac arrhythmia. Felix additionally teaches that it is possible to transmit EKG data to the hand held patient control module and have the hand held patient control module analyze the EKG data to identify the cardiac arrhythmia (e.g. paragraph 78). 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 Ritrivi with the hand held patient control module is configured to analyze the EKG data to identify the cardiac arrhythmia since such a modification would provide the predictable results of also ensuring a proper patient history log and allowing for further analysis by medical professionals, and additionally potential identification of an arrhythmia at the hand held which would have potentially greater processing power compared to the implantable device.
With regard to claim 6, Ritrivi discloses the invention as claimed but fails to teach the hand held patient control module is configured to transmit episodic data of the cardiac arrhythmia to a remote healthcare provider system. Felix teaches that it is known for the hand held patient control module is configured to transmit episodic data of the cardiac arrhythmia to a remote healthcare provider system (e.g. paragraphs 69-71, Fig. 9). 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 Ritrivi with the hand held patient control module is configured to transmit episodic data of the cardiac arrhythmia to a remote healthcare provider system since such a modification would provide the predictable results of maintaining accurate patient history and additionally providing for comparison to a larger patient population.
With regard to claim 10, Examiner considers the step of in response to receiving notification, whether cooling therapy should be delivered to the epicardial tissue of the patient to be inherent to the combined teachings of Ritrivi in view of Felix. Ritrivi discloses the use of cooling therapy for the treatment of arrhythmias (e.g. paragraph 6 and 11). It is inherent that the system and method of Ritrivi must use some indication of the arrhythmia condition, as having no means to indicate the arrhythmia would imply random application of the cooling therapy. Therefore, the combined teachings would necessarily further include the additional step of using the arrhythmia detection from Felix to trigger the application of Ritrivi’s disclosed cooling therapy.
With regard to claim 13, Ritrivi in view of Felix and FIschell disclose the invention as claimed but fails to teach stopping power transfer from the hand held patient control module in response to the EKG data becoming no longer indicative of the cardiac arrhythmia. As discussed above with respect to transferring power and activating the peltier device in response to the alert triggering, it would be equally obvious to stop transfer of power once the arrhythmia condition has been remedied as there would no longer be a reason to transfer power if there was no longer an arrhythmia present.
Response to Arguments
Applicant's arguments filed 8/26/2025 have been fully considered but they are not persuasive. Examiner has addressed these arguments above in paragraph 9. Additionally, Applicant’s fails to present any arguments why the currently amended claim language would not be obvious. As explained above, the claim amendments generally relate to limitations that define the method/system to be done “while the patient is experiencing a cardiac arrhythmia”. As explained above, Examiner’s positions as performing the method/system while the patient is experiencing the arrhythmia would be obvious because there would be a common sense reason that a user would want to treat/abate the arrhythmia as quickly as possible. Moreover, it would even appear the proposed combination of Ritrivi in view of Felix and Fischell, may even anticipate these limitations, as there does not appear to be any reasonable interpretation of the prior art that would arrive at the conclusion that any sort of treatment would be delayed of delivered after the arrhythmia has occurred and stopped. Essentially, the purpose of the prior art, Ritrivi, is to treat arrhythmias by delivering cooling therapy. The treatment serves no purpose if there is no arrhythmia.
With respect to the claim amendment(s) pertaining to the hand held patient control module being held by the patient adjacent the skin surface of the patient, as explained above, the proposed combination uses inductive coupling to transfer power to an implantable Peltier cooling device. Inductive coupling only works by aligning the external coil with the implanted coil. The coils become coupled. This is needed to transfer power at any reasonably efficiency. Therefore it is Examiner’s position that the proposed combination sufficiently anticipates these limitations, because there is no possible alternative for the disclosed inductively coupled system to not have someone such as the patient hold the controller with the external coil in some other location other than directly over the implanted coil.
Conclusion
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/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794