DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 5-6, 9 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 20100305638 to Mccabe et al. (hereinafter Mccabe). Mccabe in [0105] incorporates by reference in its entirety US 20090043351 to Sathaye et al. (hereinafter Sathaye). Mccabe in [0053] incorporates by reference in its entirety US 6772008 to Zhu et al. (hereinafter Zhu).
Regarding Claim 1, an interpretation of Mccabe discloses a method for phrenic nerve stimulation detection (abstract), the method comprising:
delivering a plurality of pacing pulses, each pacing pulse delivered between an associated pair of electrodes of a plurality of electrodes (Mccabe [0045]-[0047] including “Pacing pulses are delivered via the cathode/anode electrode combinations, where the term "electrode combination" denotes that at least one cathode electrode and at least one anode electrode are used.”, [0064]-[0065], [0107], Figs. 1, 6; Sathaye [0062], Fig. 4);
for each of the plurality of pacing pulses, measuring a corresponding diaphragm movement during delivery of the pacing pulse (Mccabe [0065]-[0067] including “One or more of the parameters can then be iteratively changed and tested to determine at which parameter settings the respiratory cycle influences phrenic nerve activation, and which cardiac pace pulse energy parameter settings are not associated with phrenic nerve activation during any phase of respiration.”, [0068] including “The diaphragmatic response due to phrenic nerve stimulation can be detected using an accelerometer signal or other vibration detection methods.”, [0107], Figs. 1, 6; Sathaye [0063]-[0065], Fig. 4, 10);
determining, for each of the plurality of pacing pulses, based on the corresponding measured diaphragm movement, whether the pacing pulse results in phrenic nerve capture (Mccabe [0065]-[0068] including “determine 140 whether the patient's phrenic nerve was stimulated by any of the pacing pulses using an accelerometer signal.”, [0137], Figs. 1, 6; Sathaye [0056], [0063]-[0065], Fig. 4); and
recording, for each pacing pulse that results in phrenic nerve capture, the pair of electrodes associated with that pacing pulse (Mccabe [0065]-[0068], [0138]; Sathaye [0056], [0064]-[0067] including “Comparing 420 can also include comparing the occurrence, amounts, and/or thresholds of phrenic nerve activation of the electrode combinations to one another”, Figs. 4, 10 see also [0159]; Examiner notes that to compare phrenic nerve activations of each electrode combination (aka pair etc.) to another electrode combination previously determined it must be recorded (aka stored or saved)).
Regarding Claim 5, an interpretation of Mccabe further discloses indicating on a display device a pair of the plurality of electrodes that is associated with a pacing pulse that results in phrenic nerve capture (Sathaye [0060] including “non-beneficial parameters . . . Parameter information, electrode combination information, and an electrode combination order, as well as other information, may be presented to a user via a display screen ” see also [0038], [0041] including “Non-beneficial parameters are parameters which are not associated with supported cardiac function in accordance with a prescribed therapy and/or are not the intended result of a prescribed therapy.”, [0063]; displays parameter information (parameter information includes non-beneficial parameters which includes phrenic activation) and electrode combination information).
Regarding Claim 6, an interpretation of Mccabe further discloses determining whether the pacing pulse results in phrenic capture comprises determining whether the pacing pulse results in phrenic nerve capture based on a frequency of the corresponding measured diaphragm movement (Mccabe [0071], [0116]; Zhu Col 5:10-50).
Regarding Claim 9, an interpretation of Mccabe further discloses determining at least one capture threshold for a pair of the plurality of electrodes that is associated with a pacing pulse that results in phrenic nerve capture (Mccabe [0054], [0065]-[0067], [0080]-[0081] including “If phrenic nerve activation is detected 650 for any of the delivered 620 pulses, then the method 600 decrements 660 the current pacing pulse parameter setting.”, Fig. 6 see also [0081]-[0082], [0107]; Sathaye [0039], [0062]-[0064] including “measuring or estimating 410 a capture threshold and phrenic nerve activation threshold for each electrode combination”, [0113] including “Undesirable activation threshold measuring may be performed by iteratively increasing, decreasing, or in some way changing a voltage, current, duration, and/or some other therapy parameter between a series of test pulses”, Fig. 4; Recites using pacing pulses to iteratively determine phrenic activation threshold which is the minimum to activate), the at least one capture threshold representing a minimum amount of electrical current necessary to stimulate the phrenic nerve (Mccabe [0054], [0065]-[0067], [0080]-[0081], Fig. 6 see also [0107]; Sathaye [0039], [0062]-[0064], [0113], Fig. 4;).
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.
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) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mccabe in view of US 20190038171 to Howard (hereinafter Howard).
Regarding Claim 2, an interpretation of Mccabe may not explicitly disclose delivering pulsed field ablation (PFA) therapy using at least some of the plurality of electrodes.
However, in the same field of endeavor (medical therapeutic systems), Howard teaches delivering pulsed field ablation therapy using at least some of the plurality of electrodes ([0045] including “The medical device 12 may be configured to deliver energy (for example, pulsed-field ablation (PFA) and/or electroporation energy) for treating or ablating an area of target tissue and also configured to deliver a pre-treatment pulse routine to evaluate a potential for non-target tissue damage from the delivery of energy.”, [0046] including “The electrode(s) 18 may deliver, for example, pulsed-field ablation energy, electroporation energy, and/or other energetic transfer with a tissue area in proximity to the area of target tissue, such as cardiac tissue.”, [0054]-[0055], [0059]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pulsed field ablation but not between electrodes which will cause phrenic activation as recited by Howard because it is merely combining prior art elements according to known methods to yield a predictable result. Phrased differently it is combining the phrenic nerve activation process of Mccabe with the PFA treatment apparatus/process of Howard to achieve the predictable result of applying PFA treatment but not between electrodes which will cause an undesired result for the phrenic nerve.
Regarding Claim 3, an interpretation of Mccabe further discloses disabling a pair of the plurality of electrodes that is associated with a pacing pulse that results in phrenic nerve capture (Mccabe [0054], [0101] including “it is generally desirable to program a pacing device so as to not risk causing undesirable stimulation, such as phrenic nerve activation”; Sathaye [0039] including “using one electrode combination may produce an undesirable activation while an identical electrical cardiac therapy delivered using another electrode combination may not produce the undesirable activation. As such, selecting an appropriate electrode combination, such as one electrode combination of a plurality of electrode combinations”; Discloses that if you have two pairs of electrodes with the same settings and one causes undesirable result while the other doesn’t you use the one that does not cause the undesirable result), such that the pair of the plurality of electrodes that is associated with a pacing pulse that results in phrenic nerve capture is not used to deliver the therapy/treatment (Mccabe [0054], [0101] including “it is generally desirable to program a pacing device so as to not risk causing undesirable stimulation, such as phrenic nerve activation”; Sathaye [0039]).
an interpretation of Mccabe may not explicitly disclose delivering pulsed field ablation treatment.
However, in the same field of endeavor (medical therapeutic systems), Howard teaches delivering pulsed field ablation therapy using at least some of the plurality of electrodes ([0045] including “The medical device 12 may be configured to deliver energy (for example, pulsed-field ablation (PFA) and/or electroporation energy) for treating or ablating an area of target tissue and also configured to deliver a pre-treatment pulse routine to evaluate a potential for non-target tissue damage from the delivery of energy.”, [0046] including “The electrode(s) 18 may deliver, for example, pulsed-field ablation energy, electroporation energy, and/or other energetic transfer with a tissue area in proximity to the area of target tissue, such as cardiac tissue.”, [0054]-[0055], [0059]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pulsed field ablation but not between electrodes which will cause phrenic activation as recited by Howard because it is merely combining prior art elements according to known methods to yield a predictable result. Phrased differently it is combining the phrenic nerve activation process of Mccabe with the PFA treatment apparatus/process of Howard to achieve the predictable result of applying PFA treatment but not between electrodes which will cause an undesired result for the phrenic nerve.
Regarding Claim 4, an interpretation of Mccabe further discloses delivering treatment comprises delivering a phrenic safe waveform between a pair of the plurality of electrodes that is associated with a pacing pulse that results in phrenic nerve capture (Mccabe [0054], [0065]-[0067] including “One or more of the parameters can then be iteratively changed and tested to determine at which parameter settings . . . cardiac pace pulse energy parameter settings are not associated with phrenic nerve activation during any phase of respiration.”, [0101] including “it is generally desirable to program a pacing device so as to not risk causing undesirable stimulation, such as phrenic nerve activation”, Fig. 6 see also [0081]-[0082], [0107]; Sathaye [0039], [0062]-[0064] including “measuring or estimating 410 a capture threshold and phrenic nerve activation threshold for each electrode combination”, Fig. 4; Recites using pacing pulses to iteratively determine what parameters cause phrenic activation so that when applying treatment the phrenic safe waveform can be applied).
an interpretation of Mccabe may not explicitly disclose delivering pulsed field ablation treatment.
However, in the same field of endeavor (medical therapeutic systems), Howard teaches delivering pulsed field ablation therapy using at least some of the plurality of electrodes ([0045] including “The medical device 12 may be configured to deliver energy (for example, pulsed-field ablation (PFA) and/or electroporation energy) for treating or ablating an area of target tissue and also configured to deliver a pre-treatment pulse routine to evaluate a potential for non-target tissue damage from the delivery of energy.”, [0046] including “The electrode(s) 18 may deliver, for example, pulsed-field ablation energy, electroporation energy, and/or other energetic transfer with a tissue area in proximity to the area of target tissue, such as cardiac tissue.”, [0054]-[0055], [0059]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pulsed field ablation but not between electrodes which will cause phrenic activation as recited by Howard because it is merely combining prior art elements according to known methods to yield a predictable result. Phrased differently it is combining the phrenic nerve activation process of Mccabe with the PFA treatment apparatus/process of Howard to achieve the predictable result of applying PFA treatment but not between electrodes which will cause an undesired result for the phrenic nerve.
Claim Rejections - 35 USC § 103
Claim(s) 7-8, 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mccabe in view of US 20250049490 to Schuler et al. (hereinafter Schuler).
Regarding Claim 7, an interpretation of Mccabe may not explicitly disclose wherein each pacing pulse has a current of 20 milliamps (mA) or less.
However, in the same field of endeavor (medical diagnostic/treatment device), Schuler teaches wherein each pacing pulse has a current of 20 milliamps (mA) or less ([0503] including “The processing system may pace the phrenic nerve by generating a pacing signal at the one or more electrodes of the mapping device and measuring the phrenic nerve response. . . . For example, the pacing signal may be a 20 mA square wave with a pulse width of 9 milliseconds (ms).”, [0527] including “The processing system may generate a 20 mA square wave”, [0531]; discloses starting at 20mA and stepping down to find the phrenic nerve capture threshold).
While not currently recited for these elements Examiner notes that Schuler also recites mapping/determining what electrodes capture the phrenic nerve ([0528], [0530]-[0531]) using diaphragmatic movement such as the velocity ([0528]; velocity is the slope of a position graph) to determine a “capture” threshold representing a min amount of electrical current necessary to stimulate the phrenic nerve ([0530]-[0531]) to avoid the undesirable complication of phrenic nerve injury ([0097], [0099]); it also discloses PFA ([0560]-[0561], Figs 30-31).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pacing currents for mapping/determining phrenic nerve activation of pairs of electrodes as recited by Schuler because it provides mapping for an ablation treatment which avoids excessive ablation that could cause collateral damage to nerves and other tissues ([0576]). Additionally, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pacing currents for mapping/determining phrenic nerve activation of pairs of electrodes as recited by Schuler because it is merely combining prior art elements according to known methods to yield a predictable result of mapping/determining phrenic nerve activation of pairs of electrodes using the particular current limitations.
Regarding Claim 8, an interpretation of Mccabe may not explicitly disclose wherein each pacing pulse has a current between 5 mA and 10 mA.
However, in the same field of endeavor (medical diagnostic/treatment device), Schuler teaches wherein each pacing pulse has a current of 20 milliamps (mA) or less ([0503] including “The processing system may pace the phrenic nerve by generating a pacing signal at the one or more electrodes of the mapping device and measuring the phrenic nerve response. . . . For example, the pacing signal may be a 20 mA square wave with a pulse width of 9 milliseconds (ms).”, [0527] including “The processing system may generate a 20 mA square wave”, [0531]; discloses starting at 20mA and stepping down to find the phrenic nerve capture threshold).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pacing currents for mapping/determining phrenic nerve activation of pairs of electrodes as recited by Schuler because it provides mapping for an ablation treatment which avoids excessive ablation that could cause collateral damage to nerves and other tissues ([0576]). Additionally, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pacing currents for mapping/determining phrenic nerve activation of pairs of electrodes as recited by Schuler because it is merely combining prior art elements according to known methods to yield a predictable result of mapping/determining phrenic nerve activation of pairs of electrodes using the particular current limitations.
While Mccabe in view of Schuler recites a broader range which includes the claimed range but may not explicitly recite the limitation of the range limited to between 5ma and 10ma, based on MPEP 2144.05(I) it is still prima facia obvious. The specification discloses the appropriate ranges that apply to the claimed invention in [0077] as “For example, in some embodiments, the pacing pulses are 20 milliamps (mA) or less. In further embodiments, the pacing pulses are in the range of 5-10 mA.” However, the specification does not disclose that the specifically claimed range(s) of 5-10 mA is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s). Because Applicants fail to disclose that the claimed range(s) of 5-10 mA provides a criticality to the invention that separates it from the other ranges in the specification it would therefore have been obvious for one of ordinary skill in the art.
Regarding Claim 10, an interpretation of Mccabe may not explicitly disclose wherein the at least one capture threshold includes a first capture threshold measured before an ablation therapy is applied and a second capture threshold measured after the ablation therapy is applied.
However, in the same field of endeavor (medical therapeutic systems), Schuler teaches wherein the at least one capture threshold includes a first capture threshold measured before an ablation therapy is applied ([0527]-[0528], [0530], [0569], [0573]-[0574], Figs. 30-31 see also [0560]-[0561]; the capture thresholds is determined as part of the mapping and then later the PFA is applied) and a second capture threshold measured after the ablation therapy is applied ([0527]-[0528], [0530], [0569], [0579], [0595], Figs. 30-31 see also [0560]-[0561], [0573]-[0574]; The reference recites the it encompasses additional steps as well as the steps can be rearranged the capture thresholds is determined as part of the mapping to repeat the process after ablation is merely duplicating the same known process which is encompassed by MPEP 2144.04(VI)).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pulsed field ablation as recited by Schuler (which also recites “mapping” which determines phrenic nerve activation of electrode pairs) because it provides mapping for an ablation treatment which avoids excessive ablation that could cause collateral damage to nerves and other tissues ([0576]).
Claim Rejections - 35 USC § 103
Claim(s) 11-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mccabe in view of Schuler.
Regarding Claim 11, an interpretation of Mccabe discloses a system for phrenic nerve stimulation detection (abstract, [0045], [0065]) comprising:
a lead comprising a plurality of electrodes disposed on the distal end ([0123]-[0125], Fig. 10 see also [0045], [0112], [0124], [0142]);
at least one energy generator connected to the plurality of electrodes ([0005], [0007], [0111], Fig. 9-10); and
at least one processor and a memory device ([0113]-[0114], Fig. 9), the at least one processor programmed to:
cause the at least one energy generator to deliver a plurality of pacing pulses, each pacing pulse delivered between an associated pair of electrodes of the plurality of electrodes (Mccabe [0045]-[0047] including “Pacing pulses are delivered via the cathode/anode electrode combinations, where the term "electrode combination" denotes that at least one cathode electrode and at least one anode electrode are used.”, [0064]-[0065], [0107], Figs. 1, 6; Sathaye [0062], Fig. 4);
for each of the plurality of pacing pulses, measure a corresponding diaphragm movement during delivery of the pacing pulse (Mccabe [0065]-[0067] including “One or more of the parameters can then be iteratively changed and tested to determine at which parameter settings the respiratory cycle influences phrenic nerve activation, and which cardiac pace pulse energy parameter settings are not associated with phrenic nerve activation during any phase of respiration.”, [0068] including “The diaphragmatic response due to phrenic nerve stimulation can be detected using an accelerometer signal or other vibration detection methods.”, [0107], Figs. 1, 6; Sathaye [0063]-[0065], Fig. 4, 10);
determine, for each of the plurality of pacing pulses, based on the corresponding measured diaphragm movement, whether the pacing pulse results in phrenic nerve capture (Mccabe [0065]-[0068] including “determine 140 whether the patient's phrenic nerve was stimulated by any of the pacing pulses using an accelerometer signal.”, [0137], Figs. 1, 6; Sathaye [0056], [0063]-[0065], Fig. 4); and
record in the memory, for each pacing pulse that results in phrenic nerve capture, the pair of electrodes associated with that pacing pulse (Mccabe [0065]-[0068], [0138]; Sathaye [0056], [0064]-[0067] including “Comparing 420 can also include comparing the occurrence, amounts, and/or thresholds of phrenic nerve activation of the electrode combinations to one another”, Figs. 4, 10 see also [0159]; Examiner notes that to compare phrenic nerve activations of each electrode combination (aka pair etc.) to another electrode combination previously determined it must be recorded (aka stored or saved)).
An interpretation of Mccabe may not explicitly disclose a catheter comprising a proximal end, a distal end, and a plurality of electrodes disposed on the distal end.
However, in the same field of endeavor (medical therapeutic device), Schuler teaches a catheter comprising a proximal end, a distal end, and a plurality of electrodes disposed on the distal end ([0560]-[0561], [0566], [0573], Figs. 15A-16C, 30 see also [0527]-[0528]).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process the lead with electrodes on it as recited by Mccabe by substituting a catheter with associated plurality of electrodes as recited by Schuler to provide the pacing pulses for making the determination because it is the simple substitution of one known element for another to obtain predictable results. Schuler itself “maps” the phrenic nerve activations using a capture element thus providing a reasonable expectation of success.
Regarding Claim 12, an interpretation of Mccabe a display device, wherein the processor is further configured to indicate on the display device a pair of electrodes that is associated with a pacing pulse resulting in phrenic nerve capture (Sathaye [0060] including “non-beneficial parameters . . . Parameter information, electrode combination information, and an electrode combination order, as well as other information, may be presented to a user via a display screen ” see also [0038], [0041] including “Non-beneficial parameters are parameters which are not associated with supported cardiac function in accordance with a prescribed therapy and/or are not the intended result of a prescribed therapy.”, [0063]; displays parameter information (parameter information includes non-beneficial parameters which includes phrenic activation) and electrode combination information).
Regarding Claim 13, an interpretation of Mccabe may not explicitly disclose wherein the at least one energy generator is configured to delivery pulsed field ablation therapy using at least some of the plurality of electrodes.
However, in the same field of endeavor (medical therapeutic systems), Schuler teaches the at least one energy generator delivering pulsed field ablation therapy using at least some of the plurality of electrodes ([0560]-[0561], [0573]-[0574] including “A PFA generator”, Figs. 30-31).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pulsed field ablation as recited by Schuler (which also recites “mapping” which determines phrenic nerve activation of electrode pairs) because it provides mapping for an ablation treatment which avoids excessive ablation that could cause collateral damage to nerves and other tissues ([0576]). Additionally, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pulsed field ablation as recited by Schuler because it is merely combining prior art elements according to known methods to yield a predictable result. Phrased differently it is combining the phrenic nerve activation process of Mccabe with the PFA treatment apparatus/process of Schuler to achieve the predictable result of applying PFA treatment.
Regarding Claim 14, an interpretation of Mccabe further discloses wherein the at least one processor is programmed to disable a pair of the plurality of electrodes that is associated with a pacing pulse that results in phrenic nerve capture (Mccabe [0054], [0101] including “it is generally desirable to program a pacing device so as to not risk causing undesirable stimulation, such as phrenic nerve activation”; Sathaye [0039] including “using one electrode combination may produce an undesirable activation while an identical electrical cardiac therapy delivered using another electrode combination may not produce the undesirable activation. As such, selecting an appropriate electrode combination, such as one electrode combination of a plurality of electrode combinations”; Discloses that if you have two pairs of electrodes with the same settings and one causes undesirable result while the other doesn’t you use the one that does not cause the undesirable result), such that the pair of the plurality of electrodes that is associated with a pacing pulse that results in phrenic nerve capture is not used to deliver the therapy/treatment (Mccabe [0054], [0101] including “it is generally desirable to program a pacing device so as to not risk causing undesirable stimulation, such as phrenic nerve activation”; Sathaye [0039]).
an interpretation of Mccabe may not explicitly disclose delivering pulsed field ablation treatment.
However, in the same field of endeavor (medical therapeutic systems), Schuler teaches delivering pulsed field ablation therapy using at least some of the plurality of electrodes ([0560]-[0561], [0574], Figs. 30-31).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pulsed field ablation as recited by Schuler (which also recites “mapping” which determines phrenic nerve activation of electrode pairs) because it provides mapping for an ablation treatment which avoids excessive ablation that could cause collateral damage to nerves and other tissues ([0576]). Additionally, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pulsed field ablation as recited by Schuler because it is merely combining prior art elements according to known methods to yield a predictable result. Phrased differently it is combining the phrenic nerve activation process of Mccabe with the PFA treatment apparatus/process of Schuler to achieve the predictable result of applying PFA treatment.
Regarding Claim 15, an interpretation of Mccabe further discloses wherein the at least one processor is programmed to cause the at least one energy generator to deliver a phrenic safe waveform between a pair of the plurality of electrodes that is associated with a pacing pulse that results in phrenic nerve capture (Mccabe [0054], [0065]-[0067] including “One or more of the parameters can then be iteratively changed and tested to determine at which parameter settings . . . cardiac pace pulse energy parameter settings are not associated with phrenic nerve activation during any phase of respiration.”, [0101] including “it is generally desirable to program a pacing device so as to not risk causing undesirable stimulation, such as phrenic nerve activation”, Fig. 6 see also [0081]-[0082], [0107]; Sathaye [0039], [0062]-[0064] including “measuring or estimating 410 a capture threshold and phrenic nerve activation threshold for each electrode combination”, Fig. 4; Recites using pacing pulses to iteratively determine what parameters cause phrenic activation so that when applying treatment the phrenic safe waveform can be applied. Examiner notes that unlike claim 4 claim 15 does not recite this is part of the pulse field ablation).
Regarding Claim 16, an interpretation of Mccabe further discloses wherein the at least one processor is programmed to determine whether the pacing pulse results in phrenic capture based on a frequency of the corresponding measured diaphragm movement (Mccabe [0071], [0116]; Zhu Col 5:10-50).
Regarding Claim 17, an interpretation of Mccabe may not explicitly disclose wherein each pacing pulse has a current of 20 milliamps (mA) or less.
However, in the same field of endeavor (medical diagnostic/treatment device), Schuler teaches wherein each pacing pulse has a current of 20 milliamps (mA) or less ([0503] including “The processing system may pace the phrenic nerve by generating a pacing signal at the one or more electrodes of the mapping device and measuring the phrenic nerve response. . . . For example, the pacing signal may be a 20 mA square wave with a pulse width of 9 milliseconds (ms).”, [0527] including “The processing system may generate a 20 mA square wave”, [0531]; discloses starting at 20mA and stepping down to find the phrenic nerve capture threshold).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pacing currents for mapping/determining phrenic nerve activation of pairs of electrodes as recited by Schuler because it provides mapping for an ablation treatment which avoids excessive ablation that could cause collateral damage to nerves and other tissues ([0576]). Additionally, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pacing currents for mapping/determining phrenic nerve activation of pairs of electrodes as recited by Schuler because it is merely combining prior art elements according to known methods to yield a predictable result of mapping/determining phrenic nerve activation of pairs of electrodes using the particular current limitations.
Regarding Claim 18, an interpretation of Mccabe may not explicitly disclose wherein each pacing pulse has a current between 5 mA and 10 mA.
However, in the same field of endeavor (medical diagnostic/treatment device), Schuler teaches wherein each pacing pulse has a current of 20 milliamps (mA) or less ([0503] including “The processing system may pace the phrenic nerve by generating a pacing signal at the one or more electrodes of the mapping device and measuring the phrenic nerve response. . . . For example, the pacing signal may be a 20 mA square wave with a pulse width of 9 milliseconds (ms).”, [0527] including “The processing system may generate a 20 mA square wave”, [0531]; discloses starting at 20mA and stepping down to find the phrenic nerve capture threshold).
It would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pacing currents for mapping/determining phrenic nerve activation of pairs of electrodes as recited by Schuler because it provides mapping for an ablation treatment which avoids excessive ablation that could cause collateral damage to nerves and other tissues ([0576]). Additionally, it would have been prima facie obvious to one of skill in the art before the effective filing date of the claimed invention to have modified the process of determining whether various electrode combinations/pairs cause phrenic nerve activation as recited by Mccabe to include pacing currents for mapping/determining phrenic nerve activation of pairs of electrodes as recited by Schuler because it is merely combining prior art elements according to known methods to yield a predictable result of mapping/determining phrenic nerve activation of pairs of electrodes using the particular current limitations.
While Mccabe in view of Schuler recites a broader range which includes the claimed range but may not explicitly recite the limitation of the range limited to between 5ma and 10ma, based on MPEP 2144.05(I) it is still prima facia obvious. The specification discloses the appropriate ranges that apply to the claimed invention in [0077] as “For example, in some embodiments, the pacing pulses are 20 milliamps (mA) or less. In further embodiments, the pacing pulses are in the range of 5-10 mA.” However, the specification does not disclose that the specifically claimed range(s) of 5-10 mA is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s). Because Applicants fail to disclose that the claimed range(s) of 5-10 mA provides a criticality to the invention that separates it from the other ranges in the specification it would therefore have been obvious for one of ordinary skill in the art.
Regarding Claim 19, an interpretation of Mccabe further discloses wherein the at least one processor is further programmed to determine at least one capture threshold for a pair of the plurality of electrodes that is associated with a pacing pulse that results in phrenic nerve capture Mccabe [0054], [0065]-[0067], [0080]-[0081] including “If phrenic nerve activation is detected 650 for any of the delivered 620 pulses, then the method 600 decrements 660 the current pacing pulse parameter setting.”, Fig. 6 see also [0081]-[0082], [0107]; Sathaye [0039], [0062]-[0064] including “measuring or estimating 410 a capture threshold and phrenic nerve activation threshold for each electrode combination”, [0113] including “Undesirable activation threshold measuring may be performed by iteratively increasing, decreasing, or in some way changing a voltage, current, duration, and/or some other therapy parameter between a series of test pulses”, Fig. 4; Recites using pacing pulses to iteratively determine phrenic activation threshold which is the minimum to activate), the at least one capture threshold representing a minimum amount of electrical current necessary to stimulate the phrenic nerve (Mccabe [0054], [0065]-[0067], [0080]-[0081], Fig. 6 see also [0107]; Sathaye [0039], [0062]-[0064], [0113], Fig. 4).
Regarding Claim 20, an interpretation of Mccabe further discloses further comprising one or more sensors configured to measure the corresponding diaphragm movement during delivery of the pacing pulse (Mccabe [0065]-[0067] including “One or more of the parameters can then be iteratively changed and tested to determine at which parameter settings the respiratory cycle influences phrenic nerve activation, and which cardiac pace pulse energy parameter settings are not associated with phrenic nerve activation during any phase of respiration.”, [0068] including “The diaphragmatic response due to phrenic nerve stimulation can be detected using an accelerometer signal or other vibration detection methods.”, [0107], Figs. 1, 6; Sathaye [0063]-[0065], Fig. 4, 10).
Conclusion
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/James Moss/Examiner, Art Unit 3792