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 .
Response to Arguments
Applicants’ arguments, see Pg. 7, filed 8/12/26, with respect to the rejection(s) of claim(s) 1 (and by extension the respective dependent claims) under 102 (and 103 in view of dependency) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Govari in view of Mccabe (see citations below). Applicants argued that while measuring movement may be disclosed measuring displacement is not disclosed by Mccabe, Examiner agreed that measuring of displacement was not explicitly disclosed by Mccabe.
Claim Rejections - 35 USC § 112
Claims 1-20 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.
Claims 1, 11 recite the limitation "corresponding measured diaphragm movement" (Claims 6, 16, 20 also explicitly recite the "corresponding measured diaphragm movement"). However, this is not recited earlier in the claim(s), thus it is unclear what diaphragm movement the element is referring to. Is this the “diaphragm displacement” or some other movement. Examiner notes this may have been an oversight and Applicant meant to have amended to match the diaphragm displacement. Regardless, as currently entered the claim does not clearly define the metes and bounds of the claim and the claim is indefinite. The claims, depending from claims 1 and 11 share this issue and are likewise rejected same reasons.
Claim Rejections - 35 USC § 102
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) 1-6, 9, 11-16, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20230051310 to Govari et al. (hereinafter Govari) in view of 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 Govari discloses a method for phrenic nerve stimulation detection (Title, [0036], [0065]), the method comprising:
delivering a pacing signal, pacing signal delivered between an associated pair of electrodes of a plurality of electrodes ([0036]-[0037], [0059], [0065]-[0066] see also [0076]);
for the pacing signal ([0036]-[0037], [0059], [0065]-[0066] see also [0076]), measuring a corresponding diaphragm displacement during delivery of the pacing signal ([0040]-[0042] including “The diaphragm movement may be indicated based one or more position signals provided by one or more position sensors”, [0065]-[0066] including “configured to compute the indices of the measurement of the diaphragm movement responsively to a measurement of displacement, and/or velocity, and/or acceleration of the diaphragm movement” see also [0036]-[0037], [0076]);
determining, for the pacing signal, based on the corresponding measured diaphragm movement, whether the pacing pulse results in phrenic nerve capture ([0038]-[0040], [0064]-[0066] including “the movement of the diaphragm is significantly larger than normal breathing and may therefore be detected using position signals provided by the body surface patches 49.”, [0072], Fig. 3 see also [0076]; recites comparing the sensed position signal of the diaphragm response to the pacing to a threshold).
While Govari recites determining the diaphragm movement in the form of displacement in response to a pacing signal, an interpretation of Govari may not explicitly disclose the pacing signal is a plurality of pacing pulses with each being delivered between a pair of electrodes; the measuring diaphragm movement for each of the plurality of pacing pulses; determining whether each of plurality of pacing pulses resulted phrenic capture; recording, for each pacing pulse that results in phrenic nerve capture, the pair of electrodes associated with that pacing pulse.
However, in the same field of endeavor (medical devices), Mccabe teaches the pacing signal is a plurality of pacing pulses with each being delivered between a pair 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.”, [0050], [0064]-[0065], [0107], Figs. 1, 6 see also [0045], [0142]; 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 see also [0045], [0142]; 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 [0050], [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)).
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 treatment system for ablation with phrenic nerve determination as recited by Govari to include performing phrenic nerve detection for a plurality of pacing pulses including between different pairs of electrodes as recited by Mccabe to periodically optimize treatment and ensure the avoidance of undesirable tissue interaction as characteristics for each electrode combination are unique and change overtime ([0045], [0050]).
Regarding Claim 2, an interpretation of Govari further discloses delivering pulsed field ablation (PFA) therapy using at least some of the plurality of electrodes ([0007], [0047], [0059] see also [0036]-[0037] see also [0076]).
Regarding Claim 3, an interpretation of Govari further discloses delivering pulsed field ablation therapy ([0007], [0047], [0059] see also [0036]-[0037], [0076]) and stopping or preventing ablation when phrenic capture is detected ([0036]-[0037], [0064] see also [0076]).
An interpretation of Govari may not explicitly disclose disabling a pair of the plurality of electrodes that is associated with a pacing pulse that results in phrenic nerve capture; 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.
However, in the same field of endeavor (medical devices), Mccabe teaches 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]).
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 treatment system for ablation with phrenic nerve determination as recited by Govari to include performing phrenic nerve detection for a plurality of pacing pulses including between different pairs of electrodes as recited by Mccabe to periodically optimize treatment and ensure the avoidance of undesirable tissue interaction as characteristics for each electrode combination are unique and change overtime ([0045], [0050]).
Regarding Claim 4, an interpretation of Govari further discloses delivering pulsed field ablation therapy ([0007], [0047], [0059], [0064] see also [0036]-[0037], [0076]).
an interpretation of Govari may not explicitly disclose 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
However, in the same field of endeavor (medical devices), Mccabe teaches 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)
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 treatment system for ablation with phrenic nerve determination as recited by Govari to include performing phrenic nerve detection for a plurality of pacing pulses including between different pairs of electrodes as recited by Mccabe to periodically optimize treatment and ensure the avoidance of undesirable tissue interaction as characteristics for each electrode combination are unique and change overtime ([0045], [0050]).
Regarding Claims 5, an interpretation of Govari further discloses a display device ([0038], [0054], [0072], Fig. 1).
an interpretation of Govari indicating on the display device a pair of the plurality of electrodes that is associated with a pacing pulse that results in phrenic nerve capture.
However, in the same field of endeavor (medical devices), Mccabe teaches 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)
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 treatment system for ablation with phrenic nerve determination including a display as recited by Govari to include the display outputting the electrodes related to determined phrenic nerve capture as recited by Mccabe because it is combining prior art elements (display as disclosed by Govari with outputting on the display determined information as disclosed by Mccabe) according to known methods to yield predictable results.
Regarding Claim 6, an interpretation of Govari may not explicitly disclose 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.
However, in the same field of endeavor (medical devices), Mccabe teaches 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).
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 treatment system for ablation with phrenic nerve determination as recited by Govari to include performing phrenic nerve detection for a plurality of pacing pulses including between different pairs of electrodes as recited by Mccabe to periodically optimize treatment and ensure the avoidance of undesirable tissue interaction as characteristics for each electrode combination are unique and change overtime ([0045], [0050]).
Regarding Claim 9, an interpretation of Govari may not explicitly disclose 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, the at least one capture threshold representing a minimum amount of electrical current necessary to stimulate the phrenic nerve.
However, in the same field of endeavor (medical devices), Mccabe teaches 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).
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 treatment system for ablation with phrenic nerve determination as recited by Govari to include performing phrenic nerve detection for a plurality of pacing pulses including between different pairs of electrodes as recited by Mccabe to periodically optimize treatment and ensure the avoidance of undesirable tissue interaction as characteristics for each electrode combination are unique and change overtime ([0045], [0050]).
Regarding Claim 11, an interpretation of Govari system for phrenic nerve stimulation detection (Title, [0036], [0065]) comprising:
a catheter comprising a proximal end, a distal end ([0044]-[0045] including “The balloon catheter 40 includes a shaft 22 and an inflatable balloon 45 fitted at a distal end of the shaft 22.”, [0047], Figs. 1-2 see also [0036]-[0037], [0076]), and a plurality of electrodes disposed on the distal end ([0046]-[0048], Figs. 1-2 see also [0036]-[0037], [0076]);
at least one energy generator connected to the plurality of electrodes ([0059], [0064], Fig. 1 see also [0036]-[0037], [0076]); and
at least one processor and a memory device ([0052] see also [0008], [0076]), the at least one processor programmed to:
cause the at least one energy generator to deliver a pacing signal, pacing signal delivered between an associated pair of electrodes of the plurality of electrodes ([0036]-[0037], [0059], [0065]-[0066] see also [0076]);
for the pacing signal ([0036]-[0037], [0059], [0065]-[0066] see also [0076]), measure a corresponding diaphragm displacement during delivery of the pacing signal ([0040]-[0042] including “The diaphragm movement may be indicated based one or more position signals provided by one or more position sensors”, [0065]-[0066] including “configured to compute the indices of the measurement of the diaphragm movement responsively to a measurement of displacement, and/or velocity, and/or acceleration of the diaphragm movement” see also [0036]-[0037], [0076]);
determine, for the pacing signal, based on the corresponding measured diaphragm movement, whether the pacing signal results in phrenic nerve capture ([0038]-[0040], [0064]-[0066] including “the movement of the diaphragm is significantly larger than normal breathing and may therefore be detected using position signals provided by the body surface patches 49.”, [0072], Fig. 3 see also [0076]; recites comparing the sensed position signal of the diaphragm response to the pacing to a threshold);
While Govari recites determining the diaphragm movement in the form of displacement in response to a pacing signal, an interpretation of Govari may not explicitly disclose the pacing signal is a plurality of pacing pulses with each being delivered between a pair of electrodes; the measuring diaphragm movement for each of the plurality of pacing pulses; determining whether each of plurality of pacing pulses resulted in phrenic capture; recording in the memory, for each pacing pulse that results in phrenic nerve capture, the pair of electrodes associated with that pacing pulse.
However, in the same field of endeavor (medical devices), Mccabe teaches the pacing signal is a plurality of pacing pulses with each being delivered between a pair 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.”, [0050], [0064]-[0065], [0107], Figs. 1, 6 see also [0045], [0142]; Sathaye [0062], Fig. 4);
for each of the plurality of pacing pulses, measuring a corresponding diaphragm movement during delivery of the pacing pulse (Mccabe [0050], [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 see also [0045], [0142]; 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 [0050], [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)).
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 treatment system for ablation with phrenic nerve determination as recited by Govari to include performing phrenic nerve detection for a plurality of pacing pulses including between different pairs of electrodes as recited by Mccabe to periodically optimize treatment and ensure the avoidance of undesirable tissue interaction as characteristics for each electrode combination are unique and change overtime ([0045], [0050]).
Regarding Claim 12, an interpretation of Govari further discloses a display device ([0038], [0054], [0072], Fig. 1)
an interpretation of Govari may not explicitly disclose indicating on the display device a pair of the plurality of electrodes that is associated with a pacing pulse that results in phrenic nerve capture.
However, in the same field of endeavor (medical devices), Mccabe teaches 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)
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 treatment system for ablation with phrenic nerve determination including a display as recited by Govari to include the display outputting the electrodes related to determined phrenic nerve capture as recited by Mccabe because it is combining prior art elements (display as disclosed by Govari with outputting on the display determined information as disclosed by Mccabe) according to known methods to yield predictable results.
Regarding Claim 13, an interpretation of Govari further discloses the energy generator configured to deliver pulsed field ablation (PFA) therapy using at least some of the plurality of electrodes ([0007], [0047], [0059] see also [0036]-[0037] see also [0076]).
Regarding Claim 14, an interpretation of Govari further discloses delivering pulsed field ablation therapy ([0007], [0047], [0059] see also [0036]-[0037], [0076]) and stopping or preventing ablation when phrenic capture is detected ([0036]-[0037], [0064] see also [0076]).
An interpretation of Govari may not explicitly disclose disabling a pair of the plurality of electrodes that is associated with a pacing pulse that results in phrenic nerve capture; 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.
However, in the same field of endeavor (medical devices), Mccabe teaches 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]).
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 treatment system for ablation with phrenic nerve determination as recited by Govari to include performing phrenic nerve detection for a plurality of pacing pulses including between different pairs of electrodes as recited by Mccabe to periodically optimize treatment and ensure the avoidance of undesirable tissue interaction as characteristics for each electrode combination are unique and change overtime ([0045], [0050]).
Regarding Claim 15, an interpretation of Govari further discloses delivering pulsed field ablation therapy ([0007], [0047], [0059], [0064] see also [0036]-[0037], [0076]).
an interpretation of Govari may not explicitly disclose 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
However, in the same field of endeavor (medical devices), Mccabe teaches 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)
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 treatment system for ablation with phrenic nerve determination as recited by Govari to include performing phrenic nerve detection for a plurality of pacing pulses including between different pairs of electrodes as recited by Mccabe to periodically optimize treatment and ensure the avoidance of undesirable tissue interaction as characteristics for each electrode combination are unique and change overtime ([0045], [0050]).
Regarding Claim 16, an interpretation of Govari may not explicitly disclose 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.
However, in the same field of endeavor (medical devices), Mccabe teaches 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).
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 treatment system for ablation with phrenic nerve determination as recited by Govari to include performing phrenic nerve detection for a plurality of pacing pulses including between different pairs of electrodes as recited by Mccabe to periodically optimize treatment and ensure the avoidance of undesirable tissue interaction as characteristics for each electrode combination are unique and change overtime ([0045], [0050]).
Regarding Claim 19, an interpretation of Govari may not explicitly disclose 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, the at least one capture threshold representing a minimum amount of electrical current necessary to stimulate the phrenic nerve.
However, in the same field of endeavor (medical devices), Mccabe teaches 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).
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 treatment system for ablation with phrenic nerve determination as recited by Govari to include performing phrenic nerve detection for a plurality of pacing pulses including between different pairs of electrodes as recited by Mccabe to periodically optimize treatment and ensure the avoidance of undesirable tissue interaction as characteristics for each electrode combination are unique and change overtime ([0045], [0050]).
Regarding Claim 20, an interpretation of Govari further discloses further comprising one or more sensors configured to measure the corresponding diaphragm movement during delivery of the pacing pulse ([0040]-[0042] including “The diaphragm movement may be indicated based one or more position signals provided by one or more position sensors”, [0065]-[0066] including “configured to compute the indices of the measurement of the diaphragm movement responsively to a measurement of displacement, and/or velocity, and/or acceleration of the diaphragm movement” see also [0036]-[0037], [0076]).
Claim Rejections - 35 USC § 103
Claim(s) 7-8, 10, 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari in view of Mccabe in further view of US 20250049490 to Schuler et al. (hereinafter Schuler).
Regarding Claim 7, an interpretation of Govari 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 Govari in view of 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 Govari in view of 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 Govari 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 Govari in view of 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 Govari in view of 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 Govari, in view of Mccabe in further 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 Govari 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 Govari in view of Mccabe to include pulsed field ablation with different thresholds 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]).
Regarding Claim 17, an interpretation of Govari 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 Govari in view of 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 Govari in view of 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 Govari 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 Govari in view of 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 Govari in view of 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 Govari, in view of Mccabe in further 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 20230264031 see fig. 9 – list of pairs used in stimulation
US 20130109994 see [0013], [0035]-[0037], [0042]
US 20180344244 see [0058]-[0060]
US 20190038171 see NF rejection dated 3/2/26 for citations
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