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 Objections
Claim 1-15 is/are objected to because of the following informalities:
In Claim 1, line 1, "Leadless pacing device" should read "A leadless pacing device".
In Claim 1-8, and 13, “the device” should recite “the leadless pacing device”.
In Claim 2-12, “Leadless pacing device according to …” lacks sufficient antecedent basis, it should recite “The/Said leadless pacing device according to …” for subsequent recitations.
In Claim 3, “a direct stimulation” lacks proper antecedent basis, it should recite “the/said direct stimulation”, as it was previously recited in claim 1.
In Claim 11, line 1, "System" should read "A system".
In Claim 13, “Method” should read “A method”.
In Claim 14, “Method” should read “The method”.
In Claim 14, “a ventricular event” should read “the ventricular event”.
In Claim 14, “the stimulation power and/or of the stimulation energy” should read “the different stimulation power and/or the different stimulation energy”.
In Claim 15, “Computer Program” should read “A computer program”.
In Claim 15, “a method of one of claims 13” should read “the method of claim 13”.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 15 is rejected under 35 U.S.C. 101 as not falling within one of the four categories of invention. The broadest reasonable interpretation of a claim drawn to a computer program/storage medium typically covers forms on non-transitory tangible media and transitory propagating signals per se in view of the ordinary and customary meaning of storage medium, particularly when the specification is silent. See MPEP 2111.01. When the broadest reasonable interpretation of a claim covers a signal per se, the claim must be rejected under 35 U.S.C. 101 as covering non- statutory subject matter. A claim drawn to such a storage medium that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments to avoid a rejection under 35 U.S.C. 101 by adding the preamble "a non- transitory medium comprising instruction to perform the method of claim" to the claim.
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) 1-2, 6-7, and 9-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20170368347 A1 to Muessig et al. (hereinafter “Muessig”).
Regarding Claim 1, Muessig teaches a leadless pacing device for implanting into an atrium of a heart (see Abstract: “an implantable leadless pacemaker (iLP) for a human or animal heart” and Para 09-11), comprising:
an implant anchor (see Para 11: “at least one fixation member”) for connecting the device to an inner wall of the atrium (see Para 10: “the iLP is configured to be anchored within a first heart chamber” and Para 11: “the first heart chamber is the atrium of the heart, such that the iLP is anchored within the myocardium of the atrium … For anchoring, the iLP comprises at least one fixation member which are located at the distal end, for example, a screw, anchor, tines, hooks, etc.”, also Para 41);
a stimulator for a direct stimulation of the atrium (see Para 10: “the stimulation control unit is configured to deliver electrical stimulation in the first heart chamber via the at least two electrode poles” and Para 11, 25, 41);
a sensor for sensing a ventricular activity of the heart (see Para 41: “ Sensing unit 20 may include a sensor for detecting a signal … Signal sensing unit 20 further comprises at least a sensor 22 for measuring an electrogram, for instance a ventricular electrogram”, also Para 10-15, 21) corresponding to the direct stimulation of the atrium (see Para 41: “… Stimulation control unit 40 comprises a pacing control unit 41 which receives information on detected atrial and/or ventricular events from the atrial event detector 31 and the detector for sensed ventricular events 32 and controls electrical stimulation according to the information via electrode 50. Moreover, the information concerning coordination of electrical stimulation can be passed from pacing control unit 41 back to the signal processing unit and the detector for sensed ventricular events 32, and the atrial event detector 31, respectively”).
Regarding Claim 2, Muessig further teaches the leadless pacing device, wherein the device is further configured to determine an occurrence or an absence of a ventricular event corresponding to the direct stimulation of the atrium, based at least in part on the sensed ventricular activity (see Para 41-45: “The signal processing unit and signal evaluation unit 30 comprise for instance an atrial event detector 31 and a detector for sensed ventricular events 32, … and the detector for sensed ventricular events 32 is configured to detect ventricular events in the signal sensed by sensor 22. Moreover, signal evaluation unit 30 is configured to relate the detected atrial and ventricular events … The atrial event detector 31 is able to detect atrio-ventricular filling events from within the ventricle by observing acoustic signals imparted on the device as a result of atrial contraction and blood ejection into the ventricle … Stimulation control unit 40 comprises a pacing control unit 41 which receives information on detected atrial and/or ventricular events from the atrial event detector 31 and the detector for sensed ventricular events 32 and controls electrical stimulation according to the information via electrode 50. Moreover, the information concerning coordination of electrical stimulation can be passed from pacing control unit 41 back to the signal processing unit and the detector for sensed ventricular events 32, and the atrial event detector 31, respectively … The atrial contraction events (indicated with arrows 61) immediately prior to ventricular events 62, which are electrically-detected QRS markers sensed in the intracardiac electrogram (IEGM). The information on the ventricular events 62 can be obtained for instance via sensor 22 in combination with sensed ventricular event detector 32 …”, also Para 15-17, 31).
Regarding Claim 6, Muessig further teaches the leadless pacing device, wherein the device is further configured to sense the ventricular activity and/or to determine the ventricular event (see Para 41: “a sensor 22 for measuring an electrogram, for instance a ventricular electrogram … the detector for sensed ventricular events 32 is configured to detect ventricular events in the signal sensed by sensor 22”) in a predetermined time window after the direct stimulation (see Para 15-17: “… The stimulation unit of the iLP according to an embodiment of the invention can be configured to deliver electrical stimulation when a time interval expires after the cardiac event of the second heart chamber has been detected … the time interval can correspond to a physiological conduction time between the first heart chamber and the second heart chamber … electrical stimulation is delivered by the iLP after the time interval has expired and when in this time interval, no intrinsic contraction of the first heart chamber has been sensed”, also Para 43-47).
Regarding Claim 7, Muessig further teaches the leadless pacing device, wherein the device is further configured to determine at least one parameter of the time window at least in part based on data, stored by the device, concerning at least one previously measured time interval of the heart (see Para 17: “the time interval can be a physiological AV conduction time. The AV conduction time can for instance be predetermined according to corresponding time intervals in the ECG, which is typically the PR interval … the time interval can be set according to typical conduction times of a healthy heart. The time interval can also be configured to dynamically adjust to other measured cardiac or physiological parameters … the time interval according to an embodiment of the invention may be determined according to previous measurements of the intrinsic conduction time of the heart … Such a calculated conduction time can be dynamically calculated and updated in the iLP”, and Para 13, 26, 43-47 (teaches determining and update the time interval used for pacing and sensing)).
Regarding Claim 9, Muessig further teaches the leadless pacing device, wherein the sensor is configured for far-field sensing (see Para 07: “electrodes placed in proximity to the heart to sense electrical depolarization fields which are generated in tissue which is not immediately adjacent to the electrode. These fields are referred to as far-field signals. In a standard dual-chamber leaded pacemaker device, the strongest far-field signals received are those from the ventricles and are often sensed by the atrial channel. Smaller far-field signals generated in the atrium are sometimes sensed in the ventricular channel”, also Para 14-15, and 18-21: “iLP is implanted within the right ventricle of the heart, the acoustic signals and/or vibrations signals acquired via the acoustic and/or vibration sensor may contain signal features representing events for contraction of the ventricle as well as contraction of the atrium”, Para 41).
Regarding Claim 10, Muessig further teaches the leadless pacing device, wherein the sensor is configured for receiving information on ventricular activity from at least one first additional sensor for implanting in a ventricle of the heart (see Para 41- 43: “Sensing unit 20 may include a sensor for detecting a signal … Signal sensing unit 20 further comprises at least a sensor 22 for measuring an electrogram, for instance a ventricular electrogram … the detector for sensed ventricular events 32 is configured to detect ventricular events in the signal sensed by sensor 22 … The information on the ventricular events 62 can be obtained for instance via sensor 22 in combination with sensed ventricular event detector 32”, and Para 18-22).
Regarding Claim 11, Muessig further teaches the leadless pacing device, system comprising the leadless pacing device (see Para 09: “an iLP device which is able to sense atrial activity, synchronize its ventricular pacing to atrial activity, and a system is desired to implement this sensing capability in the iLP device” and Para 12) and the at least one first additional sensor according to claim 10 (see Para 41: “iLP 10 comprises a sensing unit 20 … sensor 21 … sensor 22”, also see Fig.1).
Regarding Claim 12, Muessig further teaches the leadless pacing device, comprising a second additional sensor for directly sensing an atrial activity of the heart corresponding to the direct stimulation of the atrium (see Para 41-47: “iLP 10 comprises a sensing unit 20 … sensor 21 … sensor 22 … the atrial event detector 31 is configured to detect atrial events in the signal sensed by 21 … Stimulation control unit 40 comprises a pacing control unit 41 which receives information on detected atrial and/or ventricular events from the atrial event detector 31 and the detector for sensed ventricular events 32 and controls electrical stimulation according to the information via electrode 50. Moreover, the information concerning coordination of electrical stimulation can be passed from pacing control unit 41 back to the signal processing unit and the detector for sensed ventricular events 32, and the atrial event detector 31, respectively”, also see Fig.1).
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.
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 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) 3 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muessig as applied to claim 1 above, in view of US 6738669 B1 to Sloman et al. (hereinafter “Sloman”).
Regarding Claim 3, Muessig further teaches the leadless pacing device, wherein the device is configured to determine whether a direct stimulation at a predetermined stimulation power and/or a predetermined stimulation energy leads to a corresponding ventricular event (see Para 41-43: “… iLP signal evaluation unit 30, which may comprise VDD (pacemaker operation mode where electrical stimulation is performed in the ventricle according to atrial activity, involving AV conduction monitoring) timing … VDD functionality is achieved by use of atrial marker events, which start a ventricular event timer, the expiration of which will cause a ventricular pace if no intrinsic ventricular QRS has been sensed during timer countdown”, also Para 16-17, 26).
However, fails to specifically teach a predetermined stimulation power and/or a predetermined stimulation energy for direct stimulation.
Another reference, Sloman disclose an implantable cardiac stimulation device and method (see abstract), wherein the device is configured to determine whether a direct stimulation at a predetermined stimulation power and/or a predetermined stimulation energy leads to a corresponding ventricular event (see Para 24: “an electrical stimulus applied to the heart is of sufficient energy to depolarize the cardiac tissue, thereby causing the heart muscle to contract. The microcontroller 60 detects a depolarization signal during a window following a stimulation pulse, the presence of which indicates that capture has occurred” and Para 35: “the ventricular stimulation pulse(s) may be delivered upon expiration of an AV or PV interval following either an atrial stimulation pulse or atrial sensed P-wave, respectively. In FIG. 4, a ventricular stimulation pulse is shown to be delivered following a PV interval after an atrial P-wave has been sensed. The ventricular stimulation pulse(s) may also be delivered in a ventricular demand, atrial non-tracking mode, depending on the current operating conditions of the device 10” and Para 07-08, 26-29, 32-33).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the leadless pacing device of Muessig to be combined with the teaching of Sloman to direct stimulation at a predetermined stimulation power and/or a predetermined stimulation energy, such modification would improve the reliability and effectiveness of cardiac stimulation while allowing appropriate selection and verification of pacing parameters.
Regarding Claim 13, Muessig teaches a method for determining a stimulation response carried out by a leadless pacing device implanted into an atrium of a heart, comprising: (see Abstract: “an implantable leadless pacemaker (iLP) for a human or animal heart … electrode poles for picking up electrical potentials and/or delivering electrical stimulation” and Para 09-11), comprising:
performing a direct stimulation of the atrium of the heart by the device (see Para 10: “the stimulation control unit is configured to deliver electrical stimulation in the first heart chamber via the at least two electrode poles” and Para 11, 25, 41) at a predetermined stimulation power and/or a predetermined stimulation energy;
sensing a ventricular activity of the heart (see Para 41: “ Sensing unit 20 may include a sensor for detecting a signal … Signal sensing unit 20 further comprises at least a sensor 22 for measuring an electrogram, for instance a ventricular electrogram”, also Para 10-15, 21) corresponding to the direct stimulation by the device (see Para 41: “… Stimulation control unit 40 comprises a pacing control unit 41 which receives information on detected atrial and/or ventricular events from the atrial event detector 31 and the detector for sensed ventricular events 32 and controls electrical stimulation according to the information via electrode 50. Moreover, the information concerning coordination of electrical stimulation can be passed from pacing control unit 41 back to the signal processing unit and the detector for sensed ventricular events 32, and the atrial event detector 31, respectively”);
determining an occurrence or an absence of a ventricular event corresponding to the direct stimulation (see Para 41-45: “The signal processing unit and signal evaluation unit 30 comprise for instance an atrial event detector 31 and a detector for sensed ventricular events 32, … and the detector for sensed ventricular events 32 is configured to detect ventricular events in the signal sensed by sensor 22. Moreover, signal evaluation unit 30 is configured to relate the detected atrial and ventricular events … The atrial event detector 31 is able to detect atrio-ventricular filling events from within the ventricle by observing acoustic signals imparted on the device as a result of atrial contraction and blood ejection into the ventricle … Stimulation control unit 40 comprises a pacing control unit 41 which receives information on detected atrial and/or ventricular events from the atrial event detector 31 and the detector for sensed ventricular events 32 and controls electrical stimulation according to the information via electrode 50. Moreover, the information concerning coordination of electrical stimulation can be passed from pacing control unit 41 back to the signal processing unit and the detector for sensed ventricular events 32, and the atrial event detector 31, respectively … The atrial contraction events (indicated with arrows 61) immediately prior to ventricular events 62, which are electrically-detected QRS markers sensed in the intracardiac electrogram (IEGM). The information on the ventricular events 62 can be obtained for instance via sensor 22 in combination with sensed ventricular event detector 32 …”, also Para 15-17, 31).
However, fails to specifically teach a predetermined stimulation power and/or a predetermined stimulation energy for direct stimulation.
Another reference, Sloman disclose an implantable cardiac stimulation device and method (see abstract), wherein the device is configured to determine whether a direct stimulation at a predetermined stimulation power and/or a predetermined stimulation energy leads to a corresponding ventricular event (see Para 24: “an electrical stimulus applied to the heart is of sufficient energy to depolarize the cardiac tissue, thereby causing the heart muscle to contract. The microcontroller 60 detects a depolarization signal during a window following a stimulation pulse, the presence of which indicates that capture has occurred” and Para 35: “the ventricular stimulation pulse(s) may be delivered upon expiration of an AV or PV interval following either an atrial stimulation pulse or atrial sensed P-wave, respectively. In FIG. 4, a ventricular stimulation pulse is shown to be delivered following a PV interval after an atrial P-wave has been sensed. The ventricular stimulation pulse(s) may also be delivered in a ventricular demand, atrial non-tracking mode, depending on the current operating conditions of the device 10” and Para 07-08, 26-29, 32-33).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the leadless pacing device of Muessig to be combined with the teaching of Sloman to direct stimulation at a predetermined stimulation power and/or a predetermined stimulation energy, such modification would improve the reliability and effectiveness of cardiac stimulation while allowing appropriate selection and verification of pacing parameters.
Claim(s) 4-5, 8, and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muessig and Sloman as applied to claim 1, 3, 6 and 13 above, and/or further in view of US 20190290905 A1 to Yang et al. (hereinafter “Yang”).
Regarding Claim 4, Muessig further teaches the leadless pacing device, wherein the device is further configured to change a stimulation power and/or a stimulation energy of the direct stimulation (see Para 41-43: “Stimulation control unit 40 comprises a pacing control unit 41 … controls electrical stimulation according to the information via electrode 50 …”, and Para 16-17).
However, fails to specifically teach change the stimulation power and/or stimulation energy.
Sloman disclose an implantable cardiac stimulation device and method (see abstract), wherein the device is further configured to change a stimulation power and/or a stimulation energy of the direct stimulation (see Para 42: “If a far-field R-wave is not detected because the sample signal differs from the capture detection criteria, the control program 300 delivers a back-up stimulation pulse and initiates a threshold search algorithm. The threshold search algorithm redetermines the capture threshold at the present time and adjusts the stimulation pulse energy accordingly to regain capture” , and Para 12, 27, 33, 35).
Another reference, Yang also disclose an implantable medical devices, systems, and methods for ventricle-from-atrium (VfA) cardiac therapy, including single chamber or multiple chamber pacing (e.g., dual or triple chamber pacing), atrioventricular synchronous pacing, asynchronous pacing, triggered pacing, cardiac resynchronization pacing, or tachycardia-related therapy (see Para 02, 109), wherein the device is further configured to change a stimulation power and/or a stimulation energy of the direct stimulation (see Para 52: “a control circuit that uses a therapy delivery circuit to generate defibrillation shocks having any of a number of waveform properties, including leading-edge voltage, tilt, delivered energy, pulse phases, and the like. The therapy delivery circuit may, for instance, generate monophasic, biphasic, or multiphasic waveforms. Additionally, the therapy delivery circuit may generate defibrillation waveforms having different amounts of energy”, and Para 68-70, 77, 119, 199, and Fig. 6-14).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the leadless pacing device of Muessig to be combined with the teaching of Sloman and/or Yang to optimize pacing performance by providing sufficient stimulation to achieve reliable and more effective outcome while avoiding excessive energy delivery, thereby improving efficiency, device longevity, and maintaining effective stimulation.
Regarding Claim 5 and 14, Muessig further teaches the leadless pacing device, wherein the device is further configured to perform multiple direct stimulations with different stimulation powers and/or different stimulation energies to determine a threshold of the stimulation power and/or of the stimulation energy for which a ventricular event occurs (see Para 10, 16, 17 “the stimulation control unit is configured to deliver electrical stimulation” also Para 41-47).
However, fails to specifically teach stimulations with different stimulation powers and/or different stimulation energies to determine a threshold.
Sloman disclose an implantable cardiac stimulation device and method (see abstract), wherein the device is further configured to perform multiple direct stimulations with different stimulation powers and/or different stimulation energies to determine a threshold of the stimulation power and/or of the stimulation energy for which a ventricular event occurs (see Para 46: “… If capture is not verified, a back-up stimulation pulse is delivered in the left ventricle at step 665 after which the algorithm is terminated at step 670” also Para 21, 25, 29, 42-43 “The threshold search algorithm redetermines the capture threshold at the present time and adjusts the stimulation pulse energy accordingly to regain capture”, and 52).
Yang also discloses an implantable medical devices, systems, and methods (see Para 02, 109), wherein the device is further configured to perform multiple direct stimulations with different stimulation powers and/or different stimulation energies to determine a threshold of the stimulation power and/or of the stimulation energy for which a ventricular event occurs (see Para 114: “the SD transmits a control signal to the LPD to initiate CRT. The LPD senses a cardiac signal (i.e., a second electrical signal) from the heart of the patient. Based on the cardiac signal, the LPD could determine whether to deliver CRT or the type of CRT to deliver to the heart from the LPD. In one or more embodiments, the LPD, based on the second electrical signal, could initially determine that CRT should not be used. The initial determination by the LPD could use tests such as a threshold of one or more parameters. In one or more embodiments, the SD could perform a more detailed analysis as to whether CRT should be delivered. Using the sensed data from the LPD and/or SD, the SD could generate another signal to the LPD that either confirms, denies or overrides the LPDs initial determination”, and Para 52-53, 77-79, 81-85, 96, 136, 153 and Fig. 6-14).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the leadless pacing device of Muessig to be combined with the teaching of Sloman and/or Yang in order to identify the minimum stimulation output that reliably produces a ventricular event, thereby optimizing the pacing parameters, reduce unnecessary energy consumption, and maintain a reliable cardiac capture.
Regarding Claim 8, Muessig further teaches the leadless pacing device, wherein the device is further configured to determine at least one parameter of the time window at least in part based on performing a test stimulation with a test stimulation power and/or with a test stimulation energy and sensing the corresponding ventricular activity (see Para 16: “the stimulation control unit can be configured to deliver electrical stimulation in the first heart chamber in accordance with the cardiac event of the first heart chamber and/or in accordance with the cardiac event of the second heart chamber. By generating electrical stimulation based on the detected events in the first and second heart chamber, it is possible to produce pace therapy based on the information on the contraction state of the paced heart chamber and other heart chambers. As a result, the pacing pulses are applied dependent on intrinsic cardiac activity and cardiac pacing therapy can be applied in a more efficient and effective manner”, also Para 10-11, 17-20, 26, 29).
However, fails to specifically teach performing a test stimulation with a test stimulation power and/or with a test stimulation energy.
Sloman disclose an implantable cardiac stimulation device and method (see abstract), wherein the device is further configured to determine at least one parameter of the time window at least in part based on performing a test stimulation with a test stimulation power and/or with a test stimulation energy and sensing the corresponding ventricular activity (see Para 21: “Automatic threshold testing is invoked by the stimulation device when loss of ventricular capture is detected or on a predetermined periodic basis. An exemplary threshold test is performed as follows. When loss of capture is detected, the device increases the stimulation pulse energy to a relatively high predetermined testing level at which capture is certain to occur, and thereafter decrements the output energy until capture is lost. The stimulation energy is then set to a level slightly above the lowest output energy at which capture was still detected. Thus, capture verification is of utmost importance in proper determination of the stimulation energy”, also Para 41-46, 51-52).
Yang also discloses an implantable medical devices, systems, and methods (see Para 02, 109), wherein the device is further configured to determine at least one parameter of the time window at least in part based on performing a test stimulation with a test stimulation power and/or with a test stimulation energy and sensing the corresponding ventricular activity (see Para 114: “the LPD, based on the second electrical signal, could initially determine that CRT should not be used. The initial determination by the LPD could use tests such as a threshold of one or more parameters. In one or more embodiments, the SD could perform a more detailed analysis as to whether CRT should be delivered. Using the sensed data from the LPD and/or SD, the SD could generate another signal to the LPD that either confirms, denies or overrides the LPDs initial determination”, also Para 111).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the leadless pacing device of Muessig to be combined with the teaching of Sloman and/or Yang to determine an appropriate sensing time window based on the resulting ventricular activity, thereby enhancing stimulation verification, improving accuracy by reducing false detection.
Regarding Claim 15, Yang further discloses an implantable medical devices, systems, and methods (see Para 02, 109), computer program comprising instructions to perform a method of one of claims 13, when the instructions are executed by a computer (see Para 180: “the illustrative systems, methods, and interfaces may be implemented using one or more computer programs executed on programmable computers, such as computers”).
It would have been obvious to one of ordinary skill in the art as of the time of Applicant’s effective filing date of invention to modify the leadless pacing device of Muessig to be combined with the teaching of Yang to have computer executable instructions to execute pacing and sensing algorithms/control by a computer, thereby provides programmable operation and flexible control of device functions.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US-20210023377-A1 - Generally relevant art as a whole (see Abstract, Para 10-12, 38-39).
US-20210060346-A1 - Generally relevant art as a whole (see Abstract).
US-20160129263-A1 - Generally relevant art as a whole (see Abstract).
US-20160067486-A1 - Generally relevant art as a whole (see Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISRAT JAHAN whose telephone number is (571)272-8895. The examiner can normally be reached Mon-Fri: 9am-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Patel Niketa can be reached at (571) 272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/I.J./ Examiner, Art Unit 3792
/JOHN R DOWNEY/ Primary Examiner, Art Unit 3792
Prosecution Insights