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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on August 28, 2023 and October 17, 2023 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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.
Claim 15 is 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. Claim 15 recites the limitation "The system of claim 1" in line 1, but because Claim 1 does not recite a system, it appears that Claim 15 should instead depend from Claim 14, which recites a system. For the purpose of examination, Claim 15 will be read to state “The system of claim 14”.
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.
Claims 1-5 and 9-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 20210322086 A1 (Gorzycki et al.) and US 20220192741 A1 (Reinders et al.) in view of each other.
Regarding Claim 1, Gorzycki teaches a method of ablating cardiac tissue, the method comprising:
monitoring an electrical signal of a heart of a patient, the electrical signal representing the heart beating (see para. 0079; see also Fig. 6);
determining, with an electronic processor and based on the electrical signal, a time period during a previous cardiac cycle (see para. 0079; see also Fig. 6);
determining, with the electronic processor and based on the electrical signal, that another cardiac cycle has begun (see para. 0080; see also Fig. 6);
and causing, with the electronic processor, an electrode to deliver pulsed field ablation (PFA) energy to the heart during at least a portion of a time in which the time period of the another cardiac cycle is expected to occur (see para. 0030 and Fig. 6; see also para. 0024, “setting the safe period by estimating a time after the R-wave”).
However, Gorzycki does not explicitly teach the reference time period to be specifically an end-diastolic time period at an end of a diastolic time period during which diastole of the heart has occurred and delivering the PFA energy at that expected end-diastolic time.
Reinders teaches a method of ablating cardiac tissue, the method comprising:
monitoring an electrical signal of a heart of a patient, the electrical signal representing the heart beating (see e.g., Figs. 7A-7E);
determining, with an electronic processor and based on the electrical signal, an end- diastolic time period at an end of a diastolic time period during which diastole of the heart has occurred during a previous cardiac cycle (see para. 0240, “determination of the duration of a particular cardiac cycle is based on a predictive value determined based at least on a value of a duration of one or more preceding cardiac cycles”);
determining, with the electronic processor and based on the electrical signal, that another cardiac cycle has begun (see e.g., Figs. 7A-7E);
Reinders does not explicitly teach determining, with an electronic processor and based on the electrical signal, an end- diastolic time period at an end of a diastolic time period during which diastole of the heart has occurred during a previous cardiac cycle and causing, with the electronic processor, an electrode to deliver pulsed field ablation (PFA) energy to the heart during at least a portion of a time in which the end-diastolic time period of the another cardiac cycle is expected to occur. However, Reinders does teach delivering PFA energy at time intervals gated to the P-wave (see e.g. para. 0230, “Gating to the P wave can allow more PFA pulses to be delivered during each heartbeat when delivered during the atrial refractory period”) and at least partially before the R-wave (see para. 0229, “in some embodiments, the first and second particular time intervals could instead be the entire refractory periods 728a and 730b, respectively, gated to the respective Q wave in the respective QRS complex”), time periods which overlap with end-diastolic time intervals. Reinders also teaches that gating the pulse field ablation to these time periods which overlap with the end-diastolic time period protects against atrial arrhythmias and the risks of ventricular arrhythmias may be mitigated by maintaining sufficient PFA electrode distance from the ventricle or limiting delivering the pulse trains over a limited number of heart beats (see para. 0230).
It would have been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to modify the teachings of Gorzycki to provide that the method refer specifically to a reference time period that is an end-diastolic time period during which diastole of the heart has occurred, and delivering the PFA energy at that expected end-diastolic time period. Doing so could be preferable in cases where the electrodes are at sufficient distance from the ventricle or the delivery of the pulses is only for a limited number of heart beats, as recognized by Reinders.
Alternatively, it would have been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to modify the teachings of Reinders to provide that the method of ablating cardiac tissue comprise determining time periods for ablation estimated specifically in reference to a patient’s previous cardiac cycle’s corresponding time period, as taught by Gorzycki, and delivering the PFA energy at that estimated time period in the current cycle. Doing so could tailor the therapy to each patient’s current cardiac rate, and because Reinders already teaches gating to the P-wave and Q-wave, it would have been likewise obvious to set the time period around the time intervals when these waves would be expected, which would overlap with end-diastolic time periods.
Regarding Claim 2, Gorzycki teaches a method wherein determining a reference time period includes:
determining, with the electronic processor and based on the electrical signal, a first time interval between occurrences of a first wave and a second wave included in the electrical signal of one or more previous cardiac cycles (see para. 0088, “For the interval analysis, a preceding R-R interval may be stored, or an ongoing average R-R interval (such as the average of four preceding R-R intervals) may be maintained”);
wherein determining that the another cardiac cycle has begun includes determining, with the electronic processor and based on the electrical signal, that another instance of the first wave has occurred in a current cardiac cycle (see para. 0011, “the trigger means comprises sensing means configured to sense a cardiac cycle and identify one or more features of the cardiac cycle including at least the R-wave; and the analysis means comprises determining means for determining a delay from R-wave onset to a safe start time in the cardiac cycle, and a period from the safe start time to an end time during which the safe period of time is defined");
and wherein causing the electrode to deliver the PFA energy to the heart includes causing, with the electronic processor, the electrode to deliver the PFA energy to the heart during the at least a portion of the time in which the time period of the current cardiac cycle is expected to occur based on the first time interval (see para. 0089, “In use, the delay from R-wave detection to the safe window may be set to ensure that the first heart sound can be observed before ablation therapy delivery“).
Although Gorzycki does not specifically teach the reference time period to be an end-diastolic time period, it would have been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to modify the teachings of Gorzycki to provide that the method refer specifically to a reference time period that is an end-diastolic time period in view of Reinders, as discussed in Claim 1.
Likewise, it would have been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to modify the teachings of Reinders to provide that the specific method for estimating the timing of the ablation window mirrors the method anticipated by Gorzycki above (but at an end-diastolic time), as discussed in Claim 1.
Regarding Claim 3, Gorzycki teaches the first wave and the second wave are a same type of wave, and wherein the first time interval occurs between successive occurrences of a first type of wave included in the electrical signal (see para. 0088, “For the interval analysis, a preceding R-R interval may be stored”).
Regarding Claim 4, Gorzycki teaches the first time interval includes an RR interval and the first type of wave includes an R-wave (see para. 0088, “For the interval analysis, a preceding R-R interval may be stored”).
Regarding Claim 5, Gorzycki does not explicitly teach selecting a type of the first type of wave based on a location of a treatment site of the heart that is intended to receive the PFA energy. However, Reinders teaches that gating to the P-wave (as opposed to the R-wave) carries higher risk of ventricular arrhythmias, (see para. 0230, “while gating to the P wave may protect against atrial arrhythmias, the patient may be susceptible to ventricular arrhythmias during the pulse delivery . . . [but] this risk of ventricular arrhythmias may be mitigated to some degree by maintaining sufficient PFA electrode distance from the ventricle”). As such, in a combination of Gorzycki and Reinders, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to select a type of the first type of wave based on a location of a treatment site (for example, choosing a P wave if the location is away from the ventricles). Doing so could mitigate the risk of causing an arrhythmia.
Regarding Claim 9, Gorzycki teaches determining the first time interval includes:
determining a time value for each of a plurality of first time intervals included in the electrical signal over an evaluation time period before the PFA energy is delivered (see para. 0088);
and establishing the first time interval by determining an average of the time values (see para. 0088, For the interval analysis, a preceding R-R interval may be stored, or an ongoing average R-R interval (such as the average of four preceding R-R intervals) may be maintained”).
Gorzycki does not explicitly teach determining a variation between the time values; comparing the variation to a variation threshold; and in response to determining that the variation is below the variation threshold then determining the average of the time values. However, Gorzycki does teach that the time values typically have a desired low variation absent arrhythmias or misdetection (see para. 0088, “Interval analysis can thus be used by assuming that, absent misdetection and/or arrhythmia, the R-R or QRS-QRS interval is generally stable”). As such, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to determine a variation between the time values, compare the variation to a variation threshold, and in response to determining that the variation is below the variation threshold then determine the average of the time values. Doing so could filter cases where noise or misdetection would cause the average to skew.
Regarding Claim 10, Gorzycki does not explicitly teach that the evaluation time period is longer when the heart of the patient is not artificially paced than when the heart of the patient is artificially paced. However, it would have been obvious for a person having ordinary skill in the art before the effective filing date of the claimed invention to have the evaluation time period be longer when the heart of the patient is not artificially paced than when the heart of the patient is artificially paced. As discussed in Claim 9, low variability in the data of the cardiac cycles is desired to form the basis of the average, and artificially paced cardiac cycles are likely to have more consistent cardiac cycles by nature.
Regarding Claim 11, although Gorzycki does not explicitly teach determining, with the electronic processor, that the end-diastolic time period is expected to occur during a time in a range of 90% to 99% of the first time interval after the another instance of the first type of wave occurred, Reinders does teach time intervals that with overlap with that range (e.g., for R-R intervals, the QR interval of [728a] in Fig. 7A; see also para. [0229]). As such, it would have been obvious for the combination of the methods of Gorzycki and Reinders discussed in Claim 1 above to have the end-diastolic time period be expected to occur during a time in a range of 90% to 99% of the first time interval after the another instance of the first type of wave occurred.
Regarding Claim 12, the combination of Gorzycki and Reinders as discussed in Claim 1 above teaches the diastole of the heart includes one of diastole of a left ventricle, diastole of a right ventricle, diastole of a left atrium, and diastole of a right atrium (see e.g., Reinders para. 0195, “The QRS complex generally corresponds to the depolarization of the right and left ventricles of the heart”).
Regarding Claim 13, the combination of Gorzycki and Reinders as discussed in Claim 1 above teaches the end-diastolic time period of the another cardiac cycle indicates that a treatment site of the heart that is intended to receive the PFA energy includes myocardium that has a minimum thickness, compared to a thickness of the myocardium throughout the rest of the another cardiac cycle, during at least a portion of the time in which the end-diastolic time period of the another cardiac cycle is expected to occur. During the time before the occurrence of the R-wave (e.g., for R-R intervals, the QR interval of [728a] in Fig. 7A of Reinders; see also para. [0229]) the ventricular volume is typically at a maximum, and as such the ventricular wall thickness is at a minimum.
Regarding Claim 14, Gorzycki teaches a system for ablating cardiac tissue, the system comprising:
a generator including an electronic processor configured to monitor an electrical signal of a heart of a patient, the electrical signal representing the heart beating (see para. 0043);
to determine, based on the electrical signal, a reference time period during a previous cardiac cycle (see para. 0043);
and to determine, based on the electrical signal, that another cardiac cycle has begun, and to cause an electrode to deliver pulsed field ablation (PFA) energy to the heart during at least a portion of a time period of the another cardiac cycle is expected to occur (see para. 0043).
However, Gorzycki does not explicitly teach the reference time period to be specifically an end-diastolic time period at an end of a diastolic time period during which diastole of the heart has occurred and delivering the PFA energy at that expected end-diastolic time.
Reinders teaches a system for ablating cardiac tissue, the system comprising:
a generator including an electronic processor configured to monitor an electrical signal of a heart of a patient, the electrical signal representing the heart beating (see para. 0240);
determining, with an electronic processor and based on the electrical signal, an end-diastolic time period at an end of a diastolic time period during which diastole of the heart has occurred during a previous cardiac cycle (see para. 0240);
and determining, with the electronic processor and based on the electrical signal, that another cardiac cycle has begun (see e.g., Figs. 7A-7E).
Reinders further teaches delivering PFA energy at time intervals gated to the P-wave (see e.g. para. 0230, “Gating to the P wave can allow more PFA pulses to be delivered during each heartbeat when delivered during the atrial refractory period”) and at least partially before the R-wave (see para. 0229, “in some embodiments, the first and second particular time intervals could instead be the entire refractory periods 728a and 730b, respectively, gated to the respective Q wave in the respective QRS complex”), periods which overlap with end-diastolic time intervals. Reinders also teaches that gating the pulse field ablation to these periods which overlap with the end-diastolic time period protects against atrial arrhythmias and the risks of ventricular arrhythmias may be mitigated by maintaining sufficient PFA electrode distance from the ventricle or limiting delivering the pulse trains over a limited number of heart beats (see para. 0230).
It would have been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to modify the teachings of Gorzycki to provide that the system for ablating cardiac tissue is configured to refer to a reference time period that is an end-diastolic time period during which diastole of the heart has occurred, and delivering the PFA energy at that expected end-diastolic time. Doing so could be preferable in cases where the electrodes are at sufficient distance from the ventricle or the delivery of the pulses is only for a limited number of heart beats, as recognized by Reinders.
Alternatively, it would have been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to modify the teachings of Reinders to provide that the system for ablating cardiac tissue is configured to determine time periods for ablation estimated specifically in reference to the corresponding time of a patient’s previous cardiac cycle’s, as taught by Gorzycki, and delivering the PFA energy at that estimated time period in the current cycle. Doing so could tailor the therapy to each patient’s current cardiac rate, and because Reinders already teaches gating to the P-wave and Q-wave, it would have been likewise obvious to set the time period around the time intervals when these waves would be expected, which would overlap with end-diastolic time periods.
Regarding Claim 15, Gorzycki teaches a system wherein the electronic processor is configured to: determine a reference time period by determining, based on the electrical signal, a first time interval between occurrences of a first wave and a second wave included in the electrical signal of one or more previous cardiac cycles (see para. 0088, “For the interval analysis, a preceding R-R interval may be stored, or an ongoing average R-R interval (such as the average of four preceding R-R intervals) may be maintained”); wherein the electronic processor is configured to determine that the another cardiac cycle has begun by determining, based on the electrical signal, that another instance of the first wave has occurred in a current cardiac cycle (see para. 0011, “the trigger means comprises sensing means configured to sense a cardiac cycle and identify one or more features of the cardiac cycle including at least the R-wave; and the analysis means comprises determining means for determining a delay from R-wave onset to a safe start time in the cardiac cycle, and a period from the safe start time to an end time during which the safe period of time is defined"); and wherein the electronic processor is configured to cause the electrode to deliver the PFA energy to the heart by causing, the electrode to deliver the PFA energy to the heart during the at least a portion of the time in which the time period of the current cardiac cycle is expected to occur based on the first time interval (see para. 0089, “In use, the delay from R-wave detection to the safe window may be set to ensure that the first heart sound can be observed before ablation therapy delivery “).
Although Gorzycki does not specifically teach the reference time period to be an end-diastolic time period, it would have been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to modify the teachings of Gorzycki to provide that the system is configured to refer specifically to a reference time period that is an end-diastolic time period in view of Reinders, as discussed in Claim 14.
Likewise, it would have been obvious before the effective filing date of the claimed invention for a person having ordinary skill in the art to modify the teachings of Reinders to provide that the system is configured to estimate the timing of the ablation window mirroring the system anticipated by Gorzycki above (but at an end-diastolic time), as discussed in Claim 14.
Regarding Claim 16, although Gorzycki does not explicitly teach determining, with the electronic processor, that the end-diastolic time period is expected to occur during a time in a range of 90% to 99% of the first time interval after the another instance of the first type of wave occurred, Reinders does teach time intervals that with overlap with that range (e.g., for R-R intervals, the QR interval of [728a] in Fig. 7A; see also para. [0229]). It would have been obvious for the combination of the systems of Gorzycki and Reinders discussed in Claim 14 above to have the end-diastolic time period be expected to occur during a time in a range of 90% to 99% of the first time interval after the another instance of the first type of wave occurred.
Regarding Claim 17, the combination of Gorzycki and Reinders as discussed in Claim 14 above teaches the diastole of the heart includes one of diastole of a left ventricle, diastole of a right ventricle, diastole of a left atrium, and diastole of a right atrium (see e.g., Reinders para. 0195, “The QRS complex generally corresponds to the depolarization of the right and left ventricles of the heart”).
Regarding Claim 18, the combination of Gorzycki and Reinders as discussed in Claim 14 above teaches that the end-diastolic time period of the another cardiac cycle indicates that a treatment site of the heart that is intended to receive the PFA energy includes myocardium that has a minimum thickness, compared to a thickness of the myocardium throughout the rest of the another cardiac cycle, during at least a portion of the time in which the end-diastolic time period of the another cardiac cycle is expected to occur. During the time before the occurrence of the R-wave (e.g., for R-R intervals, the QR interval of [728a] in Fig. 7A of Reinders; see also para. [0229]) the ventricular volume is typically at a maximum, and as such the ventricular wall thickness is at a minimum.
Conclusion
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/C.S./Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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