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 .
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) 1-4, 7, 10 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP3348306A1 to Mussig et al. (hereinafter “Mussig”).
Regarding claims 1 and 15. (Currently Amended) Mussig discloses an implantable therapy system for an antibradycardia and antitachycardia stimulation (e.g., para 0008, 0018 etc.) , comprising: an implantable pacemaker device
Regarding claim 2. (Currently Amended) Mussig discloses the implantable therapy system according to claim 1, wherein the implantable pacemaker device is a leadless pacemaker device (e.g., para 0008, 0010 “an implantable leadless pacemaker”).
Regarding claim 3. (Currently Amended) Mussig discloses the implantable therapy system according to claim 1, wherein the implantable non-transvenous defibrillator device comprises a lead to be implanted extracardially and a shock electrode arranged on the lead (para 0013).
Regarding claim 4. (Currently Amended) Mussig discloses the implantable therapy system according to claim 1, wherein the implantable pacemaker device is configured to transmit said advertising signal prior to emitting said cardiac stimulation signal (para 0009 “detects a heart rhythm that cannot be treated via pacing pulses provided by the leadless pacemaker (e.g. low voltage therapy) and further determines that the detected heart rhythm cannot provide cardiac output required to sufficiently perfuse organs (e.g. the heart or brain of the patient) it communicates said output signal to said subcutaneous ICD to perform said electrical stimulation (e.g. high voltage therapy/delivery of shock)”.
Regarding claim 7. (Currently Amended) Mussig discloses the implantable therapy system according to claim 1, wherein the implantable pacemaker device comprises cardiac a signal generation path for generating said cardiac stimulation signal (para 0008, “the leadless pacemaker is configured to apply electrical (e.g. low voltage) pacing pulses to the heart (e.g. to said chamber)”, 0037 “a pulse generator 10b for generating said pacing pulses”).
Regarding claim 10. (Currently Amended) Mussing discloses the implantable therapy system according to claim 7, wherein the implantable pacemaker deviceThe claim does not provide any details regarding what the threshold is. Under its broadest reasonable interpretation, any communication could read over the claimed limitation).
Claim Rejections - 35 USC § 103
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.
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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5-6, 8-9, 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mussig in view of US Pat Pub no 20180207433 to Koop et al. (hereinafter “Koop”).
Regarding claim 5. (Currently Amended) Mussig discloses the implantable therapy system according to claim 1, but fails to explicitly disclose wherein the implantable pacemaker device is configured to generate said advertising signal such that said advertising signal is indicative of a timing of said cardiac stimulation signal. However, Mussig teaches ICD ideally doesn't need any heart beat sensing capabilities but is merely listening to commands from the implantable leadless pacemaker” (para 0008, 0009, 0013), as such, the signal outputted to the ICD would require all the necessary information for the ICD to perform its functions.
Koop, from a similar field of endeavor, teaches that the communication between the devices (ICD and LCP) is time-dependent, due to the physiological changes in the patient, such as but not limited to the heart H beating and/or the patient breathing (para 0054). It would have been obvious to one of ordinally skill in the art before the effective filing date of the claimed invention to modify the disclosure of Mussig with the teachings of Koop, because doing so would allow for considering the timing to provide the predictable result of improving therapy. See MPEP 2143.
Regarding claim 6. (Currently Amended) Mussig discloses the implantable therapy system according to claim 1, but fails to explicitly disclose wherein the implantable pacemaker device is configured to generate said advertising signal such that said advertising signal contains information with respect to at last one of a stimulation timing used for emitting said cardiac stimulation signal, a stimulation channel used for emitting said cardiac stimulation signal, a stimulation energy used for emitting said cardiac stimulation signal, a stimulation energy used for emitting said cardiac stimulation signal, and a status information of the implantable pacemaker device.
Mussig teaches ICD ideally doesn't need any heart beat sensing capabilities but is merely listening to commands from the implantable leadless pacemaker” (para 0008, 0009, 0013), as such, the signal outputted to the ICD would require all the necessary information for the ICD to perform its functions.
Koop, from a similar field of endeavor, teaches that the communication between the devices (ICD and LCP) is time-dependent, due to the physiological changes in the patient, such as but not limited to the heart H beating and/or the patient breathing (para 0054). It would have been obvious to one of ordinally skill in the art before the effective filing date of the claimed invention to modify the disclosure of Mussig with the teachings of Koop, because doing so would provide the predictable result of improving therapy. See MPEP 2143.
Regarding claim 8. (Currently Amended) Mussing discloses the implantable therapy system according to claim 7, but fails to explicitly disclose wherein the implantable pacemaker device is configured to generate the advertising signal using the signal generation path. Koop, from a similar field of endeavor, teaches that it is known for the LCP (pacemaker) to have pulse generator module to generate pulsing signal (para 0070, 0071, 0079). It would have been obvious to one of ordinally skill in the art before the effective filing date of the claimed invention to modify the disclosure of Mussig with the teachings of Koop, because doing so would allow for communicating commands between devices to provide therapy (Mussig, para 0009, Koop, 0052).
Regarding claim 9. (Currently Amended) Mussing as modified by Koop renders obvious the implantable therapy system according to claim 8, wherein the implantable pacemaker device
Regarding claim 11. (Currently Amended) Mussing discloses the implantable therapy system according to claim 7, but fails to disclose wherein the implantable pacemaker device is configured to generate said advertising signal as a coded pulse sequence indicative of a subsequent emission of said stimulation signal.
Koop, from a similar field of endeavor, teaches that the communication between the devices are encoded communication information (para 0089). It would have been obvious to one of ordinally skill in the art before the effective filing date of the claimed invention to modify the disclosure of Mussig with the teachings of Koop, because doing so would allow for communicating encoded information between devices to provide therapy (Koop, 0089).
Regarding claim 12. (Currently Amended) Mussing discloses the implantable therapy system according to claim 7, wherein the implantable pacemaker device is configured to transmit the advertising signal (para 0037) but fails to disclose using a communication circuitry separate from said signal generation path. Koop, from a similar field of endeavor, teaches the circuitry of the LCP and ICD (para 0070, 0071, 0079, etc.). It would have been obvious to one of ordinally skill in the art before the effective filing date of the claimed invention to modify the disclosure of Mussig with the teachings of Koop, because doing so would allow for operating the device to provide therapy (Koop, 0071). Additionally, it is noted that making components separate, without providing examples of criticality, is considered obvious. See In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding claim 13. (Currently Amended) Mussing discloses the implantable therapy system according to claim 1, wherein the implantable comprises at least one sensing electrode for sensing a cardiac signal and control circuitry for processing a sensed cardiac signal (para 0012), wherein the device is configured, for modifying said at least one processing function, to modify said processing of said sensed cardiac signal in response to receiving said advertising signal (para 0008-0009, 0015).But fails to disclose wherein the implantable non-transvenous defibrillator device comprises at least one sensing electrode.
Koop, from a similar field of endeavor, teaches the ICD (defibrillator) to sense electrical activity generated by the heart as well as provide electrical energy to the heart (para 0051). It would have been obvious to one of ordinally skill in the art before the effective filing date of the claimed invention to modify the disclosure of Mussig with the teachings of Koop to provide the predictable result of sensing electrical activity generated by the heart H as well as provide electrical energy to the heart H in order to shock the heart H from an undesired heart rhythm to a desired heart rhythm.
Regarding claim 14. (Currently Amended) Mussing as modified by Koop renders obvious the implantable therapy system according to claim 13, wherein the implantable non-transvenous defibrillator device is configured to set a blanking window in order to blank a portion of said sensed cardiac signal in a processing path for processing said sensed cardiac signal (Koop, para 0051, para 0060 “blanking period”).
Conclusion
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/SANA SAHAND/Examiner, Art Unit 3796