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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/23/2026 has been entered.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 11/10/2022, 12/27/2022, 01/01/2023, 01/22/2023, 02/05/2023, 09/18/2023, 01/14/2024, 01/28/2024, 03/31/2024, 06/16/2024, 06/23/2024, 07/21/2024, 08/11/2024, 10/27/2024, 12/25/2024, 03/13/2025, 03/20/2025, 04/23/2025, 04/23/2025, 06/12/2025, 11/27/2025, and 03/18/2026 have been considered by the examiner.
Response to Arguments
Applicant’s arguments, see Remarks filed 02/23/2026, with respect to the rejection of claims 51-57 and 59-74 under 35 USC 102/35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, new grounds of rejection as necessitated by the amended claims filed 02/23/2026 are made in view of McCabe et al (US 20100305638 A1) and Echt et al (US 20070055184 A1), detailed below.
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.
Claims 51-57 and 59-74 rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 51 is directed to the abstract idea/mental process of parameter setting based on data analysis which can generally be considered to be concepts performable in the human mind including observation, evaluation, judgement.
Examiner notes that the method of claim 51 does not recite the delivery of stimulation therapy according to the set parameters. Claim 51 is only directed to the abstract idea/mental process of setting stimulation parameters.
Step 1
Claim 51 recites a method.
Step 2A, Prong 1
Claim 51 recites the limitations of setting one or more parameters of cardiac contractility modulation stimulation with respect to at least one respiration cycle parameter. These steps, under their broadest reasonable interpretation, can be practically performed in the human mind and are thereby considered to be directed to an abstract idea/mental process. A person of ordinary skill in the art could set parameters of cardiac contractility modulation, including timing and intensity of the stimulation current, with respect to a tracked respiration cycle parameter and a stimulation pain threshold.
Step 2A, Prong 2
Claim 51 does not include any additional elements that integrate the abstract idea into a practical application.
Claim 51 includes the additional elements of tracking at least one respiration cycle parameter using one or more sensors, so that cardiac contractility stimulation parameters including timing may be set with respect to the respiration cycle parameters. The tracking of at least one respiration cycle parameter amounts to insignificant extra-solution activity of mere data gathering, in the form of performing clinical tests, in this case the tracking of respiration cycle parameters, to obtain input for an equation, wherein the equation is the process of setting the cardiac contractility stimulation parameters. See MPEP 2106.05(g), In re Grams, 888 F.2d 835.
Step 2B
Claim 51 does not include any additional elements that amount to significantly more than the abstract idea.
Claim 51 includes the additional elements of tracking at least one respiration cycle parameter using one or more sensors, so that cardiac contractility stimulation parameters including timing may be set with respect to the respiration cycle parameters. The tracking of at least one respiration cycle parameter amounts to insignificant extra-solution activity of mere data gathering, in the form of performing clinical tests, in this case the tracking of respiration cycle parameters, to obtain input for an equation, wherein the equation is the process of setting the cardiac contractility stimulation parameters. See MPEP 2106.05(g), In re Grams, 888 F.2d 835.
Additionally, the additional elements of sensors for tracking at least one respiration cycle parameter can be held to be well-understood, routine, and conventional in the art; and they are recited with a high level of generality which does not amount to significantly more than the abstract idea itself.
Claims 52, 56, 57, and 62-72 further limit the extra-solution activity of data gathering.
Claims 53-55, 59-61, and 73-74 further define the abstract idea/mental process of parameter setting.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 51-57 and 59-74 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
There is insufficient antecedent basis for the following limitation(s) in the claimset:
"the heart" in line 2 of claim 51
“the timing and intensity” in line 10 of claim 51
“the diaphragm” in line 15 of claim 51
“the phrenic nerve” in line 15 of claim 51
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.
Claims 51-56, 59-65, and 71-74 are rejected under 35 U.S.C. 103 as being unpatentable over McCabe et al (US 20100305638 A1) in view of Echt et al (US 20070055184 A1).
Regarding claim 51, McCabe teaches a method of operating an implanted cardiac device (1000) configured for delivery of cardiac stimulation to the heart, comprising:
tracking at least one respiration cycle parameter (see Fig. 1, [0061]; identifying at least one of inhalation, peak inhalation, and exhalation phases of the patient respiration based on the monitored impedance signal) using one or more sensors (see [0019]; the respiration sensor may comprise an impedance sensor); and
automatically setting, at a controller of said implanted cardiac device (see [0011]; a controller configured to execute program instructions stored in memory, [0138]; the methods described herein can be performed automatically), one or more parameters of cardiac stimulation according to said at least one respiration cycle parameter (see Fig. 6, [0075]; method 600 for finding cardiac therapy pulse parameter settings that avoid phrenic nerve activation with respect to respiratory phases, method 600 may be initiated as part of an automatic ventricular threshold test);
wherein said automatically setting one or more parameters of cardiac stimulation comprises setting both of the timing and intensity of the cardiac stimulation current to be applied during one or more selected time intervals of the respiratory cycle, as tracked by said one or more sensors (see Fig. 6, [0075-0082]; method 600 for finding cardiac therapy pulse parameter settings involves delivering at least one pulse during each respiratory phase of interest and monitoring phrenic nerve activation, if activation of the phrenic nerve occurs, then the current pacing pulse parameters are decremented, Fig. 7, [0090]; pacing pulse timing parameters, such as atrioventricular and left ventricular-right ventricular timing parameters can be adjusted to cause alignment of pacing pulse and a respiration phase of interest);
wherein said setting comprises setting an intensity of the cardiac stimulation at the highest level which does not cause pain by stimulation of the diaphragm or the phrenic nerve (see Fig. 8, [0101-0102]; a pacing pulse parameter, e.g. voltage, may be selected as being above the capture strength-duration plot 810 but below transition zone 890 as a setting that will reliably capture the appropriate chamber without occasionally activating the phrenic nerve, [0051]; left ventricular pacing may result in undesirable phrenic nerve stimulation which may cause patient discomfort and interfere with breathing).
McCabe teaches an implanted cardiac device configured for delivery of cardiac stimulation in the form of ventricular pacing pulses, wherein pulses may be applied in a timed sequency during the cardiac cycle to improve cardiac contractility (McCabe [0047]).
McCabe is silent regarding the implanted cardiac device being configured specifically for delivery of cardiac contractility modulation stimulation.
Echt teaches a type of cardiac therapy called Cardiac Contractility Modulation (CCM), comprising a pulse generator implanted in the pectoral region of a patient and transvenous leads having electrodes in direct contact with heart tissue, similar to a conventional cardiac pacemaker (Echt [0011]). Echt also discloses that it would be ideal to provide a single system to take advantage of the benefits of traditional pacing with CCM (Echt [0018]) in order to improve contractility and/or provide a system with more adaptive treatments based on patient needs.
Cardiac contractility modulation involves delivering an electrical current using a coronary sinus lead for left ventricular stimulation, during the absolute refractory period of the heart, wherein the amplitude and duration of the electrical current would be sufficient for excitation, but since it is delivered in this refractory period it is considered non-excitatory (Echt [0011], [0015]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to use McCabe’s method for determining cardiac therapy pulse parameters for the delivery of cardiac contractility modulation pulses as disclosed by Echt. One of ordinary skill in the art would have been motivated to make this modification in order to achieve increased cardiac contractility while decreasing chest pain experienced by patients caused by unwanted stimulation of the phrenic nerve by coronary sinus leads used for delivering an electrical current to the left ventricle (Echt [0015]).
Regarding claim 52, McCabe and Echt teach the method according to claim 51. McCabe further teaches wherein said at least one respiration cycle parameter is selected from the group of: a respiration rate, a relative timing of exhalation and/or inhalation, a duration of exhalation and/or inhalation (see McCabe [0012]; the plurality of different respiratory phases may comprise inhalation, peak inhalation, and expiration phases, Fig. 2 illustrating an impedance signal used to determine respiratory phases).
Regarding claim 53, McCabe and Echt teach the method according to claim 51. McCabe further teaches wherein said one or more selected time intervals of the respiratory cycle (see McCabe [0064]; cardiac pacing pulses from a left ventricular lead electrode can be timed to be delivered within each of the respiration phases, including during inspiration, peak inspiration, expiration, and non-breathing (peak expiration) phases) include one or more time intervals in which there is a larger relative anatomical space between the heart and the diaphragm and/or a larger relative anatomical space between the heart and the phrenic nerve (see McCabe [0074]; phrenic nerve activation may be respiratory phase dependent because the dimensions between the pacing electrodes and the phrenic nerve may change during the respiratory cycle, thereby changing the tissue through which the current flows, for example, as a particular patient inhales the current path between pacing electrodes may be more likely to traverse an area proximate the phrenic nerve, such that the patient is more susceptible to phrenic nerve activation during inhalation).
Regarding claim 54, McCabe and Echt teach the method according to claim 53. McCabe further teaches synchronizing timing for applying the cardiac stimulation with timing in which the diaphragm is farthest from the heart and/or with timing in which the phrenic nerve is farthest from the heart (see McCabe [0056]; phases of respiration may be linked with susceptibility to phrenic nerve activation, for example, some subjects are more susceptible to phrenic nerve activation when the subjects are inhaling relative to other portions of the respiratory cycle, such as exhalation; some subjects are more susceptible to phrenic nerve activation when they are at the deepest part of their breaths, e.g. at the point of maximum inhalation, relative to other portions of the respiratory cycle; some subjects are less susceptible to phrenic nerve activation when the subject is exhaling or between breaths, e.g., not inhaling or exhaling, relative to other portions of the respiratory cycle, [0074]; phrenic nerve activation may be respiratory phase dependent because the dimensions between the pacing electrodes and the phrenic nerve may change during the respiratory cycle, thereby changing the tissue through which the current flows, [0108]; therapy timing parameters can be automatically adjusted as needed to avoid delivering a pacing pulse during a respiratory phase determined to be associated with phrenic nerve stimulation).
It can be appreciated that for the particular patient described by McCabe in paragraphs [0072-0074], the current path between cardiac pacing electrodes may be more likely to traverse an area proximate the phrenic nerve during an inhalation phase, making them more susceptible to phrenic nerve activation during inhalation. Therefore, for this particular patient, it would be advantageous to apply cardiac stimulation during a non-inhalation phase, such as exhalation, when the relative dimensions of the cardiac pacing electrodes and phrenic nerve are less likely to traverse an area which may trigger phrenic nerve activation (McCabe [0108-0109]), thereby selecting a time interval of the respiratory cycle when the phrenic nerve is farthest from the heart and least likely to be activated by a cardiac stimulation pulse. It can be appreciated that the phases of increased phrenic nerve activation stimulation may vary by subject as a result of the subject’s particular physiology including anatomy (McCabe [0056]).
McCabe teaches an implanted cardiac device configured for delivery of cardiac stimulation in the form of ventricular pacing pulses, however McCabe is silent regarding the delivery of said ventricular pulses for cardiac contractility modulation stimulation.
Echt teaches an implanted cardiac device configured for delivery of ventricular pulses for cardiac contractility modulation stimulation involving delivering an electrical current using a coronary sinus lead for left ventricular stimulation during the absolute refractory period of the heart, wherein the amplitude and duration of the electrical current would be sufficient for excitation, but since it is delivered in this refractory period it is considered non-excitatory (Echt [0011], [0015]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to use McCabe’s method for determining cardiac therapy pulse parameters for the delivery of cardiac contractility modulation pulses as disclosed by Echt. One of ordinary skill in the art would have been motivated to make this modification in order to decrease chest pain experienced by patients caused by unwanted stimulation of the phrenic nerve by coronary sinus leads used for delivering an electrical current to the left ventricle (Echt [0015]).
Regarding claim 55, McCabe and Echt teach the method according to claim 51. McCabe is silent regarding wherein automatically setting one or more parameters of cardiac contractility modulation stimulation comprises setting timing for applying the cardiac contractility modulation stimulation, said timing being during an absolute refractory period of the cardiac cycle.
Echt teaches wherein automatically setting one or more parameters of cardiac contractility modulation stimulation comprises setting timing for applying the cardiac contractility modulation stimulation, said timing being during an absolute refractory period of the cardiac cycle (see Echt [0011]; for CCM therapy, electrical current is delivered during or immediately after a heart beat when the heart is unable to initiate another beat, known as the absolute refractory period).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to use McCabe’s method for determining cardiac therapy pulse parameters for the delivery of cardiac contractility modulation pulses during an absolute refractory period of the cardiac cycle as disclosed by Echt. One of ordinary skill in the art would have been motivated to make this modification in order to increase tissue contractility during a heart beat by delivering a non-excitatory pulse to the left ventricle (Echt [0011]).
Regarding claim 56, McCabe and Echt teach the method according to claim 51. McCabe further teaches wherein said one or more sensors may be an acoustic sensor (see McCabe [0113]; phrenic nerve activation sensor 910 may include an acoustic sensor).
Regarding claim 59, McCabe and Echt teach the method according to claim 51. McCabe further teaches wherein said automatically setting one or more parameters of cardiac contractility modulation stimulation comprises setting a rate for applying multiple cardiac contractility modulation stimulations (see McCabe [0108]; pacing therapy timing parameters can be automatically adjusted as needed to avoid delivering a pacing pulse during a respiratory phase determined to be associated with phrenic nerve stimulation).
Regarding claim 60, McCabe and Echt teach the method according to claim 59, comprising increasing the rate of cardiac contractility modulation stimulations when detecting a rise in respiration rate, and decreasing the rate of cardiac contractility modulation stimulations when detecting decrease in respiration rate (see McCabe [0090]; pacing pulse timing parameters can be adjusted to cause alignment of a pacing pulse and a respiration phase of interest).
Regarding claim 61, McCabe and Echt teach the method according to claim 51. McCabe further teaches wherein said cardiac device is implanted in a patient diagnosed with heart failure (see McCabe [0051]; provides therapy options for patients suffering from heart failure).
Additionally, Echt also teaches wherein said cardiac device is implanted in a patient diagnosed with heart failure (see Echt [0019]; it would be desirable to provide an implantable device with the beneficial effects of cardiac contractility therapy in order to improve cardiac function in heart failure patients or to prevent heart failure in other patients).
It would have been obvious to one of ordinary skill to use the implanted cardiac device in a patient diagnosed with heart failure in order to improve cardiac function in heart failure patients by increasing cardiac tissue contractility (Echt [0011]).
Regarding claim 62, McCabe and Echt teach the method according to claim 51. McCabe further teaches wherein one or more selected time intervals of the respiratory cycle include one or more time intervals in which there is a larger distance between at least one lead of said implanted cardiac device and the phrenic nerve (see McCabe [0056]; phases of respiration may be linked with susceptibility to phrenic nerve activation, for example, some subjects are more susceptible to phrenic nerve activation when the subjects are inhaling relative to other portions of the respiratory cycle, such as exhalation; some subjects are more susceptible to phrenic nerve activation when they are at the deepest part of their breaths, e.g. at the point of maximum inhalation, relative to other portions of the respiratory cycle; some subjects are less susceptible to phrenic nerve activation when the subject is exhaling or between breaths, e.g., not inhaling or exhaling, relative to other portions of the respiratory cycle, [0074]; phrenic nerve activation may be respiratory phase dependent because the dimensions between the pacing electrodes and the phrenic nerve may change during the respiratory cycle, thereby changing the tissue through which the current flows , [0108]; determine which respiratory phase(s) are associated with phrenic nerve activation and which are not, therefore pacing pulses can only be delivered during those phases which are not associated with phrenic nerve stimulation and/or pacing therapy timing parameters can be automatically adjusted as needed to avoid delivering a pacing pulse during a respiratory phase determined to be associated with phrenic nerve stimulation).
It can be appreciated that for the particular patient described by McCabe in paragraphs [0072-0074], the current path between cardiac pacing electrodes may be more likely to traverse an area proximate the phrenic nerve during an inhalation phase, making them more susceptible to phrenic nerve activation during inhalation. Therefore, for this particular patient, it would be advantageous to apply cardiac stimulation during a non-inhalation phase, such as exhalation, when the relative dimensions of the cardiac pacing electrodes and phrenic nerve are less likely to traverse an area which may trigger phrenic nerve activation (McCabe [0108-0109]), thereby selecting a time interval of the respiratory cycle when there is a larger distance between the implanted cardiac device and the phrenic nerve. It can be appreciated that the phases of increased phrenic nerve activation stimulation may vary by subject as a result of the subject’s particular physiology including anatomy (McCabe [0056]).
Regarding claims 63, 64, and 65, McCabe and Echt teach the method according to claim 62. McCabe further teaches wherein said one or more time intervals are selected by testing during which time interval(s) said applying does not cause or only least causes sensation to the patient (see McCabe [0108]; determine which respiratory phase(s) are associated with phrenic nerve activation and which are not, therefore pacing pulses can only be delivered during those phases which are not associated with phrenic nerve stimulation and/or pacing therapy timing parameters can be automatically adjusted as needed to avoid delivering a pacing pulse during a respiratory phase determined to be associated with phrenic nerve stimulation);
wherein said one or more time intervals include a time interval which is during the inhalation period or the exhalation period (see McCabe [0109]; scanning aspects can be used to identify a phrenic nerve activation for each phase of interest, such as inspiration, peak inspiration, expiration, and non-breathing, be delivering cardiac pacing pulses during these phases and scanning across one or more pulse energy parameters).
Regarding claim 71, McCabe and Echt teach the method according to claim 51. McCabe further teaches assessing, according to the at least one measured respiration cycle parameter, cardiac output and/or respiratory output over time and timing the applying of cardiac stimulation accordingly (see McCabe [0108]; determine which respiratory phase(s) are associated with phrenic nerve activation and which are not, therefore pacing pulses can only be delivered during those phases which are not associated with phrenic nerve stimulation and/or pacing therapy timing parameters can be automatically adjusted as needed to avoid delivering a pacing pulse during a respiratory phase determined to be associated with phrenic nerve stimulation).
McCabe teaches an implanted cardiac device configured for delivery of cardiac stimulation in the form of ventricular pacing pulses, however McCabe is silent regarding the delivery of said ventricular pulses for cardiac contractility modulation stimulation.
Echt teaches an implanted cardiac device configured for delivery of ventricular pulses for cardiac contractility modulation stimulation involving delivering an electrical current using a coronary sinus lead for left ventricular stimulation during the absolute refractory period of the heart, wherein the amplitude and duration of the electrical current would be sufficient for excitation, but since it is delivered in this refractory period it is considered non-excitatory (Echt [0011], [0015]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to use McCabe’s method for determining cardiac therapy pulse parameters for the delivery of cardiac contractility modulation pulses as disclosed by Echt. One of ordinary skill in the art would have been motivated to make this modification in order to decrease chest pain experienced by patients caused by unwanted stimulation of the phrenic nerve by coronary sinus leads used for delivering an electrical current to the left ventricle (Echt [0015]).
Regarding claim 72, McCabe and Echt teach the method according to claim 62. McCabe further teaches assessing if the patient has sensed the cardiac contractility modulation stimulation, and selecting a different time interval of the respiratory cycle for applying of said cardiac contractility modulation stimulation if the stimulation was sensed (see McCabe [0108]; determine which respiratory phase(s) are associated with phrenic nerve activation and which are not, therefore pacing pulses can only be delivered during those phases which are not associated with phrenic nerve stimulation and/or pacing therapy timing parameters can be automatically adjusted as needed to avoid delivering a pacing pulse during a respiratory phase determined to be associated with phrenic nerve stimulation).
McCabe teaches an implanted cardiac device configured for delivery of cardiac stimulation in the form of ventricular pacing pulses, however McCabe is silent regarding the delivery of said ventricular pulses for cardiac contractility modulation stimulation.
Echt teaches an implanted cardiac device configured for delivery of ventricular pulses for cardiac contractility modulation stimulation involving delivering an electrical current using a coronary sinus lead for left ventricular stimulation during the absolute refractory period of the heart, wherein the amplitude and duration of the electrical current would be sufficient for excitation, but since it is delivered in this refractory period it is considered non-excitatory (Echt [0011], [0015]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to use McCabe’s method for determining cardiac therapy pulse parameters for the delivery of cardiac contractility modulation pulses as disclosed by Echt. One of ordinary skill in the art would have been motivated to make this modification in order to decrease chest pain experienced by patients caused by unwanted stimulation of the phrenic nerve by coronary sinus leads used for delivering an electrical current to the left ventricle (Echt [0015]).
Regarding claim 73, McCabe and Echt teach the method according to claim 51. McCabe further teaches wherein automatically setting comprises selecting said one or more parameters of cardiac stimulation taking into account anatomical changes occurring during the respiration cycle (see McCabe [0074]; phrenic nerve activation may be respiratory phase dependent because the dimensions between the pacing electrodes and the phrenic nerve may change during the respiratory cycle, thereby changing the tissue through which the current flows, [0108]; determine which respiratory phase(s) are associated with phrenic nerve activation and which are not, therefore pacing pulses can only be delivered during those phases which are not associated with phrenic nerve stimulation and/or pacing therapy timing parameters can be automatically adjusted as needed to avoid delivering a pacing pulse during a respiratory phase determined to be associated with phrenic nerve stimulation).
McCabe teaches an implanted cardiac device configured for delivery of cardiac stimulation in the form of ventricular pacing pulses, however McCabe is silent regarding the delivery of said ventricular pulses for cardiac contractility modulation stimulation.
Echt teaches an implanted cardiac device configured for delivery of ventricular pulses for cardiac contractility modulation stimulation involving delivering an electrical current using a coronary sinus lead for left ventricular stimulation during the absolute refractory period of the heart, wherein the amplitude and duration of the electrical current would be sufficient for excitation, but since it is delivered in this refractory period it is considered non-excitatory (Echt [0011], [0015]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to use McCabe’s method for determining cardiac therapy pulse parameters for the delivery of cardiac contractility modulation pulses as disclosed by Echt. One of ordinary skill in the art would have been motivated to make this modification in order to decrease chest pain experienced by patients caused by unwanted stimulation of the phrenic nerve by coronary sinus leads used for delivering an electrical current to the left ventricle (Echt [0015]).
Regarding claim 74, McCabe and Echt teach the method according to claim 51. McCabe further teaches skipping the applying of said cardiac stimulation during one or more respiratory cycles based on said tracked parameters of the respiratory cycle (see McCabe [0108]; determine which respiratory phase(s) are associated with phrenic nerve activation and which are not, therefore pacing pulses can only be delivered during those phases which are not associated with phrenic nerve stimulation and/or pacing therapy timing parameters can be automatically adjusted as needed to avoid delivering a pacing pulse during a respiratory phase determined to be associated with phrenic nerve stimulation).
McCabe teaches an implanted cardiac device configured for delivery of cardiac stimulation in the form of ventricular pacing pulses, however McCabe is silent regarding the delivery of said ventricular pulses for cardiac contractility modulation stimulation.
Echt teaches an implanted cardiac device configured for delivery of ventricular pulses for cardiac contractility modulation stimulation involving delivering an electrical current using a coronary sinus lead for left ventricular stimulation during the absolute refractory period of the heart, wherein the amplitude and duration of the electrical current would be sufficient for excitation, but since it is delivered in this refractory period it is considered non-excitatory (Echt [0011], [0015]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to use McCabe’s method for determining cardiac therapy pulse parameters for the delivery of cardiac contractility modulation pulses as disclosed by Echt. One of ordinary skill in the art would have been motivated to make this modification in order to decrease chest pain experienced by patients caused by unwanted stimulation of the phrenic nerve by coronary sinus leads used for delivering an electrical current to the left ventricle (Echt [0015]).
Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over McCabe et al (US 20100305638 A1) in view of Echt et al (US 20070055184 A1) and Armoundas (US 20160331273 A1).
Regarding claim 57, McCabe and Echt teach the method according to claim 51. McCabe further teaches wherein said one or more sensors include an intra-cardiac electrode for sensing electrical signals from the patient’s heart (McCabe [0122]).
They are silent regarding wherein said determining at least one respiration cycle parameter is based on said ECG recording.
Armoundas teaches a system/method for determining respiratory information, such as respiratory rate, from intra-cardiac electrocardiographic signals (Armoundas [0003]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify McCabe’s method for tracking at least one respiration cycle parameter by determining the one or more respiratory cycle parameters using an intra-cardiac electrocardiogram as taught by Armoundas. One of ordinary skill in the art would have been motivated to make this modification in order to determine respiratory cycle parameters/information of a subject undergoing cardiac stimulation therapy without the need for cumbersome specialized respiration monitoring systems (Armoundas [0007-0008]).
Claims 66 and 67 are rejected under 35 U.S.C. 103 as being unpatentable over McCabe et al (US 20100305638 A1) in view of Echt et al (US 20070055184 A1) and Asirvatham et al (US 20190060632 A1).
Regarding claims 66 and 67, McCabe and Echt teach the method according to claim 62. They are silent regarding recording an EGG of the patient and selecting a time for applying of cardiac contractility modulation stimulation when an amplitude of the R wave of a current cardiac cycle is higher than an average R wave amplitude calculated based on at least 5 previous cardiac cycles; or
selecting a time for applying of cardiac contractility modulation stimulation when an amplitude of the R wave of a current cardiac cycle is lower than an average R wave amplitude calculated based on at least 5 previous cardiac cycles.
Asirvatham teaches a method for determining when a therapeutic pulse may be deliverable to a patient based on the electrocardiogram signal (Asirvatham, Abstract), comprising recording an EGG of the patient and selecting a time for applying of cardiac contractility modulation stimulation when an amplitude of the R wave of a current cardiac cycle is higher than an average R wave amplitude or lower than an average R wave amplitude calculated based on at least 5 previous cardiac cycles (see Asirvatham Fig. 2C, [0011-0013]; measuring and averaging approximately 30 initial R wave amplitudes to establish a standard deviation, and calculating a rolling average by averaging a series of 4 R-wave amplitudes and comparing the rolling average to the initial average including a standard deviation, if the rolling average is within the initial average + a standard deviation, then a therapeutic pulse may be delivered on the fifth heartbeat and if the rolling average is outside of the standard deviation, then a therapeutic pulse may not be delivered).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify McCabe’s method for delivering cardiac stimulation pulses by establishing a rate of stimulation pulses based on previous R-wave amplitudes as taught by Asirvatham. One of ordinary skill in the art would have been motivated to make this modification in order to keep a patient safe during the delivery of therapeutic pulses by ensuring that the pulses are delivered at the desired timing coinciding with the absolute refractory period (Asirvatham [0004]).
Claims 68 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over McCabe et al (US 20100305638 A1) in view of Echt et al (US 20070055184 A1) and Armoundas et al (US 20070191890 A1), hereinafter referred to as Armoundas ‘07.
Regarding claims 68 and 69, McCabe and Echt teach the method according to claim 62. They are silent regarding recording an EGG of the patient and selecting a time for applying of cardiac contractility modulation stimulation when the RR interval of a current cardiac cycle is longer than an average RR interval calculated based on at least 5 previous cardiac cycles; or
selecting a time for applying of cardiac contractility modulation stimulation when the RR interval of a current cardiac cycle is shorter than an average RR interval calculated based on at least 5 previous cardiac cycles.
Armoundas ‘07 teaches a method for cardiovascular treatment using an implanted cardiac device which measures beat-to-beat variability in the morphology of electrocardiographic waveforms and uses the measured beat-to-beat variability to control the delivery of electrical impulses to the heart during the absolute refractory period (Armoundas ‘07, Abstract), comprising,
selecting a time for applying of cardiac contractility modulation stimulation when the RR interval of a current cardiac cycle is longer or shorter than an average RR interval (see Armoundas ‘07 [0039]; when the heart rate variability is less than the threshold value for some period of time then therapy is delivered, [0043]; when there is an alternation in the beat duration, the electrical impulse is delivered at a time interval after the end of repolarization in the beats with the shorter beat duration, this time interval is longer than the diastolic interval that follows the beats with the longer beat duration, [0052]) calculated based on at least 5 previous cardiac cycles (see Armoundas ’07 [0039]; a threshold value of heart variability may be established such as the standard deviation of normal to normal RR intervals measure of heart rate variability being equal to 60 milliseconds).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify McCabe’s method for operating an implanted cardiac device by using Armounda ‘07’s heart rate variability threshold to trigger the delivery of an electrical pulse. One of ordinary skill in the art would have been motivated to make this modification in order to increase/decrease the heart rate variability as desired and thus reduce the likelihood that a heart rhythm disturbance will occur (Armoundas ]07 [0039]).
Claim 70 is rejected under 35 U.S.C. 103 as being unpatentable over McCabe et al (US 20100305638 A1) in view of Echt et al (US 20070055184 A1) and Beck et al (US 20080071185 A1).
Regarding claim 70, McCabe and Echt teach the method according to claim 51. They are silent regarding tracking at least one respiration cycle parameter comprises detecting a dyspnea episode, and applying cardiac contractility modulation stimulation in response.
Beck teaches a method for detecting disordered breathing events and triggering an appropriate therapeutic response to said event, wherein the breathing disordered event may be a dyspnea episode (Beck [0006]), and the therapeutic response may be cardiac contractility modulation stimulation (Beck [0057]).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify McCabe and Echt’s method for delivering cardiac contractility modulation with respect to respiratory parameters by using Beck’s method for identifying disordered breathing events. One of ordinary skill in the art would have been motivated to make this modification in order to deliver the appropriate treatment to a patient experiencing a dyspnea episode.
Conclusion
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/A.J.S./Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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