DETAILED ACTION
The following is an action on the merits. Claims 1-32 are being examined.
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 .
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.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1 and 2 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims as a whole, considering all claim elements both individually and in combination, so not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a pulsed field ablation system. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any juridical exception. The following limitations set forth a judicial exception:
“… cause, in association with a first state in which a first plurality of consecutive cardiac cycles of a patient exhibit a non-irregular heart rate, a first pulsed field ablation transducer located on a catheter device to deliver pulsed field ablation energy during each of some, but not all, of the first plurality of consecutive cardiac cycles, the some, but not all, of the first plurality of consecutive cardiac cycles excluding at least one cardiac cycle of the first plurality of consecutive cardiac cycles during which no pulsed field ablation energy is delivered by the first pulsed field ablation transducer…”
These limitations describe an abstract idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrated the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“…an input-output device system; a memory device system storing a program; and a data processing device system communicatively connected to the input-output device system and the memory device system, the data processing device system…”
The additional limitations of the claim do not integrate the judicial exception into a practical application. Rather, the additional limitations are recited at a high level of generality, i.e., a general purpose computer.
Dependent claim 2 also fails to add something more to the abstract independent claim as it merely further limits the abstract idea.
Claims 3-32 are not rejected under 101 because independent claim 3 is not directed towards an abstract idea. Independent claim 1 differs from independent claim 3 because it includes the “cause” limitation, reproduced above in paragraph 6, which is directed towards an abstract idea. In contrast, independent claim 3 recites an identification step and determination steps not found in independent claim 1 in order to activate the device. It is suggested that applicant amend the claims rejected under 35 U.S.C. 101 to recite a clear step that causes a transformation.
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.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Fraasch et al., (hereinafter ‘Fraasch,’ U.S. PGPub. No. 2020/0138506) in view of Asirvatham et al., (hereinafter ‘Asirvatham,’ U.S. PGPub. No. 2019/0060632).
Regarding claim 1, Fraasch discloses a pulsed field ablation system (abstract; PFA system 26 in Fig. 4) comprising: an input-output device system (interface/input means 48); a memory device system (control unit 30 including computer) storing a program; and a data processing device system (master processor unit (MPU) (not labeled) communicatively connected to the input-output device system and the memory device system (Fig. 4). Fraasch further discloses the data processing device system configured at least by the program at least to: cause, a first pulsed field ablation transducer located on a catheter device to deliver pulsed field ablation energy ([0083], “ the PFA generator 22 may be configured to deliver ablative energy pulses in the range of approximately 0.1 microsecond to 100 microseconds in duration and at frequencies of approximately 20 Hz to 2000 Hz. In one embodiment, the PFA generator 22 and/or control unit 30 is configured such that the user is able to modulate or adjust one or more characteristics of the pulses 12, such as rise-fall time τ and/or pulse width T. Optionally, the PFA generator 22 may also be configured to deliver ablative energy (such as radiofrequency (RF) energy, laser energy, microwave energy, or the like) or the control unit 30 may include an additional energy generator for providing ablative energy).”).
Fraasch is silent regarding in association with a first state in which a first plurality of consecutive cardiac cycles of a patient exhibit a non-irregular heart rate, a first pulsed field ablation transducer located on a catheter device to deliver pulsed field ablation energy during each of some, but not all, of the first plurality of consecutive cardiac cycles, the some, but not all, of the first plurality of consecutive cardiac cycles excluding at least one cardiac cycle of the first plurality of consecutive cardiac cycles during which no pulsed field ablation energy is delivered by the first pulsed field ablation transducer, the excluded at least one cardiac cycle of the first plurality of consecutive cardiac cycles occurring between at least two cardiac cycles of the some, but not all, of the first plurality of consecutive cardiac cycles.
However, in the same field of endeavor, Asirvatham teaches a similar system that implements pacing before electroporation pulse delivery, during electroporation pulse delivery, and/or after electroporation pulse delivery. Such pacing may be used on a patient having a regular heartbeat. Asirvatham teaches “[i]t may be advantageous to use pacing for patients having any of a fast, regular, or irregular heartbeat so that the refractory period may be controllable and it may be known exactly when to deliver a pulse. The heart rhythm may be monitored, e.g., by monitoring the electrocardiogram (EKG, EGM), for a regular and/or irregular heartbeat and heart rate. Pacing may be advantageous because long pace intervals will increase the refractory period, to safely deliver one to a plurality of electroporation pulses per heartbeat, thereby delivering therapy faster. . . . In some embodiments, pacing simulating a heartbeat may be applied continuously throughout a procedure.” ([0083]). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the system as taught by Fraasch to include in association with a first state in which a first plurality of consecutive cardiac cycles of a patient exhibit a non-irregular heart rate, a first pulsed field ablation transducer located on a catheter device to deliver pulsed field ablation energy during each of some, but not all, of the first plurality of consecutive cardiac cycles, the some, but not all, of the first plurality of consecutive cardiac cycles excluding at least one cardiac cycle of the first plurality of consecutive cardiac cycles during which no pulsed field ablation energy is delivered by the first pulsed field ablation transducer, the excluded at least one cardiac cycle of the first plurality of consecutive cardiac cycles occurring between at least two cardiac cycles of the some, but not all, of the first plurality of consecutive cardiac cycles, as taught by Asirvatham, in order to provide electroporation pulses at the optimal and safest time, thereby delivering therapy faster and increasing control.
Regarding claim 2, Fraasch in view of Asirvatham teach all the limitations of the system according to claim 1. In view of the prior modification of Fraasch in view of Asirvatham, Asirvatham wherein the non-irregular heart rate is a constant heart rate ([0083]; see Fig. 3A).
Claims 3-11, 15-25, 27-28 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Weinkam et al., (hereinafter ‘Weinkam,’ U.S. PGPub. No. 2017/0224414) in view of Mickelsen et al., (hereinafter ‘Mickelsen.’ U.S. PGPub. No. 2017/0065343).
Regarding claim 3, Weinkam discloses an ablation system (Fig. 3) comprising: an input-output device system (input-output device system 320); a memory device system (330) storing a program ([0147], “ a memory device system (e.g., memory device systems 130, 330) … stores a program executable by the data processing device system”); and a data processing device system (310) communicatively connected to the input-output device system (320) and the memory device system (330), the data processing device system (310) configured at least by the program at least to: identify a particular ablation transducer set (transducers 306, first transducer set 380, second transducer set 382 in Fig. 3C) of a catheter device (Fig. 3), the particular ablation transducer set identified from a plurality of ablation transducers (transducers 306) of the catheter device (Fig. 3), and the particular ablation transducer set identified to be activated to apply ablation between the ablation transducers of the particular ablation transducer set, the energy sufficient to cause ablation of tissue ([0129], “the plurality of transducers 306 are arranged to form a two- or three-dimensional distribution, grid or array of the transducers capable of mapping, ablating or stimulating an inside surface of a bodily cavity or lumen”); in association with a first state in which the identified particular ablation transducer set is a first set of ablation transducers (first transducer set 380) of the catheter device, and in association with a second state in which the identified particular ablation transducer set is a second set of ablation transducers (second transducer set 382) of the catheter device different than the first set of ablation transducers ([0145], “In some embodiments, a first transducer set (e.g., a first set including one or more of transducers 306) is arranged (e.g., axially, circumferentially, or both axially and circumferentially arranged) along, across, or over a portion of catheter body 314 while a second set (e.g., a second set including one or more of transducers 306) is located on structure 308 extending outwardly from a distal end 314a of catheter body 314. An example first transducer set 380 and example second transducer set 382 are shown in FIG. 3C according to some embodiments.”).
Although Weinkam discloses an ablation transducer set comprising a first and second transducer set, Weinkam is silent regarding pulsed field ablation, and the data processing system configured to determine a first particular parameter set of the high voltage pulse train and cause activation, via the input- output device system, of the identified particular pulsed field ablation transducer set to deliver the high voltage pulse train in accordance with the determined first particular parameter set; and determine a second particular parameter set of the high voltage pulse train different than the first particular parameter set and cause activation, via the input-output device system, of the identified particular pulsed field ablation transducer set to deliver the high voltage pulse train in accordance with the determined second particular parameter set.
However, in the same field of endeavor, Mickelsen teaches a similar ablation system comprising pulse field ablation, wherein a controller is capable of applying control inputs with programmable voltage pulse parameters, as well as a programmable selection of electrodes. Further, “[t]he generator can output waveforms that can be selected to generate a sequence of voltage pulses in either monophasic or biphasic forms and with either constant or progressively changing amplitudes.” ([0040]; also see [0043]). The controller unit (21) “can perform channel selection and routing functions for applying DC voltages to appropriate electrodes that have been selected by a user or by the computer 24, and apply the voltages via a multiplicity of leads (shown collectively as 26) to a catheter device 22.” ([0047]). The particular electrodes can be selected for the voltage pulse delivery, and the ablation pulse train can be initiated with the pulse train parameters (such as for example individual pulse parameters, number of pulses in the pulse train) having been programmed ([0057]). By providing programed pulse parameters associated with a particular electrodes set, this configuration results in well-controlled and specific delivery of electroporation in an efficacious manner ([0030]). Therefore, it would have been obvious to one having ordinary skill in the art to have modified the system as taught by Weinkam to include pulsed field ablation, and the data processing system configured to determine a first particular parameter set of the high voltage pulse train and cause activation, via the input- output device system, of the identified particular pulsed field ablation transducer set to deliver the high voltage pulse train in accordance with the determined first particular parameter set; and determine a second particular parameter set of the high voltage pulse train different than the first particular parameter set and cause activation, via the input-output device system, of the identified particular pulsed field ablation transducer set to deliver the high voltage pulse train in accordance with the determined second particular parameter set, as taught by Mickelsen, in order to provide well-controlled and specific delivery of electroporation in an efficacious manner ([0030]), thereby increasing control, accuracy and safety.
Regarding claim 4, Weinkam (Fig. 3) discloses in the first state in which the identified particular pulsed field ablation transducer set is the first set of pulsed field ablation transducers of the catheter device, the first set of pulsed field ablation transducers has a first number of pulsed field ablation transducers (380), and wherein, in the second state in which the identified particular pulsed field ablation transducer set is the second set of pulsed field ablation transducers of the catheter device (382), the second set of pulsed field ablation transducers has a second number of pulsed field ablation transducers greater than the first number of pulsed field ablation transducers (as best illustrated in Fig. 3C).
Regarding claim 5, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. In view of the prior modification of Weinkam in view of Mickelsen, Weinkam (Fig. 3) discloses wherein each pulsed field ablation transducer of the identified particular pulsed field ablation transducer set comprises a respective electrode (electrode 315, 415 in Figs. 3C and 4), each respective electrode (315, 415) including a respective energy delivery surface (“[0132], “Electrodes 415 have respective electrode edges 415-1 that form a periphery of an electrically conductive surface associated with the respective electrode 415.”) configured to deliver pulsed field ablation energy, wherein, in the first state in which the identified particular pulsed field ablation transducer set is the first set of pulsed field ablation transducers of the catheter device, the energy delivery surfaces of the first set of pulsed field ablation transducers have a first collective area (area 380), and wherein, in the second state in which the identified particular pulsed field ablation transducer set is the second set of pulsed field ablation transducers of the catheter device, the energy delivery surfaces of the second set of pulsed field ablation transducers have a second collective area greater than the first collective area (second area 382).
Regarding claim 6, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. In view of the prior modification of Weinkam in view of Mickelsen, Weinkam (Fig. 3) discloses each pulsed field ablation transducer of the identified particular pulsed field ablation transducer set comprises a respective electrode (electrode 315, 415 in Figs. 3C and 4), each respective electrode including a respective energy delivery surface configured to deliver pulsed field ablation energy (“[0132], “Electrodes 415 have respective electrode edges 415-1 that form a periphery of an electrically conductive surface associated with the respective electrode 415.”), wherein, in the first state in which the identified particular pulsed field ablation transducer set is the first set of pulsed field ablation transducers of the catheter device (380), the energy delivery surfaces of the first set of pulsed field ablation transducers have a first set of one or more geometric shapes (Fig. 4), and wherein, in the second state in which the identified particular pulsed field ablation transducer set is the second set of pulsed field ablation transducers of the catheter device (382).
Weinkam in view of Mickelsen are silent regarding the energy delivery surfaces of the second set of pulsed field ablation transducers have a second set of one or more geometric shapes different than the first set of one or more geometric shapes. However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Weinkam in view of Mickelsen to include the energy delivery surfaces of the second set of pulsed field ablation transducers have a second set of one or more geometric shapes different than the first set of one or more geometric shapes. This would have been an obvious matter of design choice to make the different portions of the energy delivery surfaces of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 7, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. Weinkam (Fig. 3) discloses wherein the particular pulsed field ablation transducer set (380, 382) is identified based at least on a selection of at least two pulsed field ablation transducers of the catheter device (Fig. 3). In view of the prior modification of Weinkam in view of Mickelsen, Mickelsen teaches each pulsed field ablation transducer of the at least two pulsed field ablation transducers configured to selectively deliver energy sufficient for pulsed field ablation of tissue (abstract; see [0048], “Multiple DC voltage pulses can be applied in a pulse train to ensure that sufficient tissue ablation has occurred. Further, the user can repeat the delivery of irreversible electroporation over several distinct pulse trains for further confidence.” Also see [0057]).
Regarding claim 8, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 7. Weinkam (Fig. 3) discloses wherein the selection of the at least two pulsed field ablation transducers of the catheter device is a user selection of the at least two pulsed field ablation transducers (see Fig. 1 for display system 100 allows for user selection of transducers; [0115]).
Regarding claim 9, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. Weinkam (Fig. 3) discloses wherein the data processing device system (310) is configured at least by the program at least to perform an analysis of a total number of at least the pulsed field ablation transducers in the particular pulsed field ablation transducer set ([0174]; as broadly claimed, the transducer data of all active transducers is analyzed).
Regarding claim 10, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 9. Weinkam (Fig. 3) discloses wherein, in the first state, the analysis of the total number of the at least the pulsed field ablation transducers in the particular pulsed field ablation transducer set is an analysis of a total number of pulsed field ablation transducers in the first set of pulsed field ablation transducers (first transducer set 380), wherein, in the second state, the analysis of the total number of the at least the pulsed field ablation transducers in the particular pulsed field ablation transducer set is an analysis of a total number of pulsed field ablation transducers in the second set of pulsed field ablation transducers (second transducer set 382) ([0147]; [0174]; as broadly claimed, the transducer data of all active transducers is analyzed), wherein, in the first state, the first particular parameter set of the high voltage pulse train is determined based at least on the analysis of the total number of pulsed field ablation transducers in the first set of pulsed field ablation transducers (first set 380), and wherein, in the second state, the second particular parameter set of the high voltage pulse train is determined based at least on the analysis of the total number of pulsed field ablation transducers in the second set of pulsed field ablation transducers (second set 382).
Regarding claim 11, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. Weinkam (Fig. 3) discloses wherein the data processing device system (310) is configured at least by the program at least to perform an analysis of a transducer type of each pulsed field ablation transducer of at least the pulsed field ablation transducers of the particular pulsed field ablation transducer set ([0147]; [0174]; as broadly claimed, the transducer data of all active transducers is analyzed).
Regarding claim 15, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. Weinkam (Fig. 3) discloses wherein the particular pulsed field ablation transducer set is identified based at least on an analysis of degree of tissue contact exhibited by at least the pulsed field ablation transducers of the particular pulsed field ablation transducer set ([0183], “One or more of the above-discussed mapping procedures may be implemented according to instructions associated with block 604 to display a graphical representation 500 that includes intra-cardiac information that indicates at least a portion of one or more anatomical features based at least on an analysis of the transducer data provided according to block 602. . . . In some embodiments, flow identifier 527a provides a graduated scale from a condition indicated as “Contact” (e.g., when a transducer is contact with cardiac tissue) to a condition indicated as “Flow” (e.g., when a transducer overlies a port in the cardiac chamber).”).
Regarding claim 16, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. Weinkam (Fig. 3) discloses wherein the particular pulsed field ablation transducer set is identified based at least on an analysis of data provided by each pulsed field ablation transducer of at least the pulsed field ablation transducers of the particular pulsed field ablation transducer set ([0147]; [0174]; as broadly claimed, the transducer data of all active transducers is analyzed).
Regarding claim 17, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. In view of the prior modification of Weinkam in view of Mickelsen, Weinkam (Fig. 3) discloses wherein each pulsed field ablation transducer (306) of the identified particular pulsed field ablation transducer set comprises a respective electrode (electrode 315, 415 in Figs. 3C and 4), each respective electrode including a respective energy delivery surface (“[0132], “Electrodes 415 have respective electrode edges 415-1 that form a periphery of an electrically conductive surface associated with the respective electrode 415.”) configured to deliver pulsed field ablation energy (see Mickelsen for delivery of pulsed field ablation energy), and wherein (a) in the first state in which the identified particular pulsed field ablation transducer set is the first set of pulsed field ablation transducers of the catheter device, the energy delivery surfaces of the first set of pulsed field ablation transducers have a same area (first set 380 in Fig. 3C), or (b) in the second state in which the identified particular pulsed field ablation transducer set is the second set of transducers of the catheter device, the energy delivery surfaces of the second set of transducers have a same area (second set 382 in Fig. 3C).
Regarding claim 18, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 17. In view of the prior modification of Weinkam in view of Mickelsen, Weinkam (Fig. 3) discloses wherein each pulsed field ablation transducer (306) of the identified particular pulsed field ablation transducer set comprises a respective electrode (electrode 315, 415 in Figs. 3C and 4), each respective electrode including a respective energy delivery surface (“[0132], “Electrodes 415 have respective electrode edges 415-1 that form a periphery of an electrically conductive surface associated with the respective electrode 415.”) configured to deliver pulsed field ablation energy (see Mickelsen for delivery of pulsed field ablation energy), and wherein (c) in the first state in which the identified particular pulsed field ablation transducer set is the first set of pulsed field ablation transducers of the catheter device, the energy delivery surfaces of the first set of pulsed field ablation transducers have a same geometric shape (see transducers 306 of first set 380 for same geometric shape), or (d) in the second state in which the identified particular pulsed field ablation transducer set is the second set of pulsed field ablation transducers of the catheter device, the energy delivery surfaces of the second set of pulsed field ablation transducers have a same geometric shape (see transducers 306 of first set 380 for same geometric shape).
Regarding claim 19, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. In view of the prior modification of Weinkam in view of Mickelsen, Weinkam (Fig. 3) discloses wherein each pulsed field ablation transducer (306) of the identified particular pulsed field ablation transducer set comprises a respective electrode (electrode 315, 415 in Figs. 3C and 4), each respective electrode including a respective energy delivery surface (“[0132], “Electrodes 415 have respective electrode edges 415-1 that form a periphery of an electrically conductive surface associated with the respective electrode 415.”) configured to deliver pulsed field ablation energy (see Mickelsen for delivery of pulsed field ablation energy), wherein, in the first state in which the identified particular pulsed field ablation transducer set is the first set of pulsed field ablation transducers of the catheter device (first set 380), each energy delivery surface of at least one energy delivery surface of the first set of pulsed field ablation transducers has a first area (Fig. 3C and 4), and wherein, in the second state in which the identified particular pulsed field ablation transducer set is the second set of pulsed field ablation transducers of the catheter device (second set 382), each energy delivery surface of at least one energy delivery surface of the second set of pulsed field ablation transducers has a second area different than the first area (see Fig. 3C which illustrates first and second area 380, 382 are different areas).
Regarding claim 20, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. In view of the prior modification of Weinkam in view of Mickelsen, Weinkam (Fig. 3) discloses wherein each pulsed field ablation transducer (306) of the identified particular pulsed field ablation transducer set comprises a respective electrode (electrode 315, 415 in Figs. 3C and 4), each respective electrode including a respective energy delivery surface (“[0132], “Electrodes 415 have respective electrode edges 415-1 that form a periphery of an electrically conductive surface associated with the respective electrode 415.”) configured to deliver pulsed field ablation energy (see Mickelsen for delivery of pulsed field ablation energy), wherein, in the first state in which the identified particular pulsed field ablation transducer set is the first set of pulsed field ablation transducers of the catheter device (first set 380), the energy delivery surface of each of at least one pulsed field ablation transducer of the first set of pulsed field ablation transducers has a first area (see Figs. 3 and 4), and wherein, in the second state in which the identified particular pulsed field ablation transducer set is the second set of pulsed field ablation transducers of the catheter device (second set 382), the energy delivery surfaces of each of at least one pulsed filed ablation transducer of the second set of pulsed field ablation transducers has a second area the same as the first area (as broadly claimed, each individual energy delivery surface of each of at least one pulsed filed ablation transducers have the same surface area, i.e., are the same in size).
Regarding claim 21, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. In view of the prior modification of Weinkam in view of Mickelsen, Weinkam (Fig. 3) discloses wherein each pulsed field ablation transducer (306) of the identified particular pulsed field ablation transducer set comprises a respective electrode (electrode 315, 415 in Figs. 3C and 4), each respective electrode including a respective energy delivery surface (“[0132], “Electrodes 415 have respective electrode edges 415-1 that form a periphery of an electrically conductive surface associated with the respective electrode 415.”) configured to deliver pulsed field ablation energy (see Mickelsen for delivery of pulsed field ablation energy), and wherein, each energy delivery surface of the first set of pulsed field ablation transducers in the first state has a different area than each energy delivery surface of the second set of pulsed field ablation transducers in the second state (see Fig. 3C for first set 380 and second set 382 which occupy different areas of the device).
Regarding claim 22, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. In view of the prior modification of Weinkam in view of Mickelsen, Weinkam (Fig. 3) discloses wherein each pulsed field ablation transducer (306) of the identified particular pulsed field ablation transducer set comprises a respective electrode (electrode 315, 415 in Figs. 3C and 4), each respective electrode including a respective energy delivery surface (“[0132], “Electrodes 415 have respective electrode edges 415-1 that form a periphery of an electrically conductive surface associated with the respective electrode 415.”) configured to deliver pulsed field ablation energy (see Mickelsen for delivery of pulsed field ablation energy), wherein, in the first state in which the identified particular pulsed field ablation transducer set is the first set of pulsed field ablation transducers of the catheter device (first set 380), each energy delivery surface of at least one energy delivery surface of the first set of pulsed field ablation transducers has a first geometric shape (Fig. 3C and 4), and wherein, in the second state in which the identified particular pulsed field ablation transducer set is the second set of pulsed field ablation transducers of the catheter device (second set 382).
Weinkam in view of Mickelsen are silent regarding each energy delivery surface of at least one energy delivery surface of the second set of pulsed field ablation transducers has a second geometric shape different than the first geometric shape.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Weinkam in view of Mickelsen to include each energy delivery surface of at least one energy delivery surface of the second set of pulsed field ablation transducers has a second geometric shape different than the first geometric shape. This would have been an obvious matter of design choice to make the different portions of the energy delivery surfaces of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 23, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 19. In view of the prior modification of Weinkam in view of Mickelsen, Weinkam (Fig. 3) discloses wherein the respective energy delivery surfaces of the first set of pulsed field ablation transducers (380) in the first state have a same area (see Fig. 3C).
Regarding claim 24, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 23. In view of the prior modification of Weinkam in view of Mickelsen, Weinkam (Fig. 3) discloses wherein the respective energy delivery surfaces of the second set of transducers (382) in the second state have a same area (see Fig. 3C).
Regarding claim 25, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. In view of the prior modification of Weinkam in view of Mickelsen, Mickelsen teaches wherein each high voltage pulse in the high voltage pulse train is configured to deliver a respective amount of pulse energy (abstract; [0057]).
Weinkam in view of Mickelsen are silent regarding wherein the pulse energy deliverable by each of at least one high voltage pulse in the high voltage pulse train in accordance with the second particular parameter set is less than the pulse energy deliverable by each of at least one high voltage pulse in the high voltage pulse train in accordance with the first particular parameter set.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Weinkam in view of Mickelsen to include wherein the pulse energy deliverable by each of at least one high voltage pulse in the high voltage pulse train in accordance with the second particular parameter set is less than the pulse energy deliverable by each of at least one high voltage pulse in the high voltage pulse train in accordance with the first particular parameter set, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 27, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. In view of the prior modification of Weinkam in view of Mickelsen, Mickelsen teaches wherein each of the first particular parameter set and the second particular parameter set defines a respective pulse duration of each of at least one high voltage pulse in the high voltage pulse train, (see [0057], the particular electrodes can be selected for the voltage pulse delivery, and the ablation pulse train can be initiated with the pulse train parameters (such as for example individual pulse parameters, number of pulses in the pulse train) having been programmed; [0058]; [0061]).
Weinkam in view of Mickelsen are silent wherein the respective pulse duration of each of the at least one high voltage pulse in the high voltage pulse train defined in accordance with the second particular parameter set is less than the respective pulse duration of each of the at least one high voltage pulse in the high voltage pulse train defined in accordance with the first particular parameter set.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Weinkam in view of Mickelsen to include wherein the respective pulse duration of each of the at least one high voltage pulse in the high voltage pulse train defined in accordance with the second particular parameter set is less than the respective pulse duration of each of the at least one high voltage pulse in the high voltage pulse train defined in accordance with the first particular parameter set, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 28, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. In view of the prior modification of Weinkam in view of Mickelsen, Mickelsen teaches wherein each of the first particular parameter set and the second particular parameter set defines a respective pulse frequency of the pulses in the high voltage pulse train (see [0057], the particular electrodes can be selected for the voltage pulse delivery, and the ablation pulse train can be initiated with the pulse train parameters (such as for example individual pulse parameters, number of pulses in the pulse train) having been programmed; [0058]; [0061]).
Weinkam in view of Mickelsen are silent regarding wherein the respective pulse frequency of the pulses in the high voltage pulse train defined in accordance with the second particular parameter set is lower than the respective pulse frequency of the pulses in the high voltage pulse train defined in accordance with the first particular parameter set.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Weinkam in view of Mickelsen to include wherein the respective pulse frequency of the pulses in the high voltage pulse train defined in accordance with the second particular parameter set is lower than the respective pulse frequency of the pulses in the high voltage pulse train defined in accordance with the first particular parameter set, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 31, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3. Weinkam (Fig. 3) discloses wherein the high voltage pulse train is a first high voltage pulse train of a plurality of high voltage pulse trains, wherein the data processing device system (310) is configured at least by the program at least to cause activation, via the input-output device system (320), of the particular pulsed field ablation transducer set (306) to deliver each high voltage pulse train of the plurality of high voltage pulse trains during a respective cardiac cycle of a plurality of cardiac cycles (abstract; also see [0061], “The data processing device system may be configured by the program at least to cause an ablation electrode to transmit energy sufficient for tissue ablation at least during the sampling of the intra-cardiac voltage data by the sensing electrode.” As broadly claimed, ablation is provided during a cardiac cycle; also see heart 202 in Fig. 2).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Weinkam in view of Mickelsen as applied to claims 3 and 11 above, and further in view of Vitek et al., (hereinafter ‘Vitek,’ U.S. PGPub. No. 2011/0066032).
Regarding claim 12, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 11. Weinkam (Fig. 3) discloses wherein, in the first state, the analysis of a transducer type of each pulsed field ablation transducer in the at least the pulsed field ablation transducers in the particular pulsed field ablation transducer set is an analysis of a transducer type of each pulsed field ablation transducer in the first set of pulsed field ablation transducers (380), wherein, in the second state, the analysis of a transducer type of each pulsed field ablation transducer in the at least the pulsed field ablation transducers in the particular pulsed field ablation transducer set is an analysis of a transducer type of each pulsed field ablation transducer in the second set of pulsed field ablation transducers (382) ([0147]; [0174]; as broadly claimed, the transducer data of all active transducers is analyzed).
Weinkam in view of Mickelsen are silent regarding wherein, in the first state, the first particular parameter set of the high voltage pulse train is determined based at least on the analysis of a transducer type of each pulsed field ablation transducer in the first set of pulsed field ablation transducers, and wherein, in the second state, the second particular parameter set of the high voltage pulse train is determined based at least on the analysis of a transducer type of each pulsed field ablation transducer in the second set of pulsed field ablation transducers.
However, in the same field of endeavor, Vitek teaches a similar system that analyzes various inputs, including parameters characterizing the transducer array (including, for example, the number, size, shape, and density of elements in the array), as input to produce an optimal grouping pattern and/or determine optimal drive frequencies for each group ([0027]). This allows for the most efficient and accurate use of the transducers for their desired purpose. Further, “the controller facilitates the dynamic adjustment and configuration of elements within the transducer system based on a particular clinical application and a particular desired location of the focus within the anatomy. ” ([0027]). Therefore, it would it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Weinkam in view of Mickelsen to include wherein, in the first state, the first particular parameter set of the high voltage pulse train is determined based at least on the analysis of a transducer type of each pulsed field ablation transducer in the first set of pulsed field ablation transducers, and wherein, in the second state, the second particular parameter set of the high voltage pulse train is determined based at least on the analysis of a transducer type of each pulsed field ablation transducer in the second set of pulsed field ablation transducer, as taught by Vitek in order to facilitate the dynamic adjustment and configuration of elements within the transducer system based on particular clinical application and a particular desired location of the focus within the anatomy, thereby improving efficiency and accuracy of the system.
Regarding claim 13, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3, but are silent regarding wherein the data processing device system is configured at least by the program at least to perform an analysis of size, shape, or size and shape of each pulsed field ablation transducer of at least the pulsed field ablation transducers of the particular pulsed field ablation transducer set.
However, in the same field of endeavor, Vitek teaches a similar optimization algorithm that analyzes various inputs, including parameters characterizing the transducer array (including, for example, the number, size, shape, and density of elements in the array), as input to produce an optimal grouping pattern and/or determine optimal drive frequencies for each group ([0027]). This allows for the most efficient and accurate use of the transducers for their desired purpose. Further, “the controller facilitates the dynamic adjustment and configuration of elements within the transducer system based on a particular clinical application and a particular desired location of the focus within the anatomy. ” ([0027]). Therefore, it would it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the system as taught by Weinkam in view of Mickelsen to include wherein the data processing device system is configured at least by the program at least to perform an analysis of size, shape, or size and shape of each pulsed field ablation transducer of at least the pulsed field ablation transducers of the particular pulsed field ablation transducer set, as taught by Vitek in order to facilitate the dynamic adjustment and configuration of elements within the transducer system based on a particular clinical application and a particular desired location of the focus within the anatomy, thereby improving efficiency and accuracy of the system.
Regarding claim 14, Weinkam in view of Mickelsen and Vitek teach all of the limitations of the system according to claim 13. In view of the prior modification of Weinkam in view of Mickelsen and Vitek, Vitek discloses wherein, in the first state, the analysis of size, shape, or size and shape of each pulsed field ablation transducer in the at least the pulsed field ablation transducers in the particular pulsed field ablation transducer set is an analysis of size, shape, or size and shape of each pulsed field ablation transducer in the first set of pulsed field ablation transducers (see [0027], “ an optimization algorithm may take this information, along with parameters characterizing the transducer array (including, for example, the number, size, shape, and density of elements in the array), as input to produce an optimal grouping pattern and/or determine optimal drive frequencies for each group.”), wherein, in the second state, the analysis of size, shape, or size and shape of each pulsed field ablation transducer in the at least the pulsed field ablation transducers in the particular pulsed field ablation transducer set is an analysis of size, shape, or size and shape of each pulsed field ablation transducer in the second set of pulsed field ablation transducers (see [0027], “ an optimization algorithm may take this information, along with parameters characterizing the transducer array (including, for example, the number, size, shape, and density of elements in the array), as input to produce an optimal grouping pattern and/or determine optimal drive frequencies for each group.”), wherein, in the first state, the first particular parameter set of the high voltage pulse train is determined based at least on the analysis of size, shape, or size and shape of each pulsed field ablation transducer in the first set of pulsed field ablation transducers, and wherein, in the second state, the second particular parameter set of the high voltage pulse train is determined based at least on the analysis of size, shape, or size and shape of each pulsed field ablation transducer in the second set of pulsed field ablation transducers (see [0027], “ an optimization algorithm may take this information, along with parameters characterizing the transducer array (including, for example, the number, size, shape, and density of elements in the array), as input to produce an optimal grouping pattern and/or determine optimal drive frequencies for each group. . . . the controller facilitates the dynamic adjustment and configuration of elements within the transducer system based on a particular clinical application and a particular desired location of the focus within the anatomy. ”).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Weinkam in view of Mickelsen as applied to claim 3 above, and further in view of Fraasch.
Regarding claim 26, Weinkam in view of Mickelsen teach all of the limitations of the system according to claim 3, but are silent regarding wherein each high voltage pulse in the high voltage pulse train comprises a respective rise time, and wherein the respective rise time of each high voltage pulse of the high voltage pulse train in accordance with the second particular parameter set is longer than the respective rise time of each high voltage pulse of the high voltage pulse train in accordance with t