DETAILED ACTION
The amendment filed December 2, 2024, has been entered and fully considered. Claims 1, 5-16, 26-.15 are pending. Claims 1 and 40 are amended and claims 46-51 are newly added.
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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 14, and 34-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fraasch et al., (hereinafter 'Fraasch', U.S. PGPub. No. 2018/0214195).
Regarding claim 1, Fraasch (Fig. 1) discloses a method of treating a target cardiac tissue area of a patient ([0004]; [0068] for treating cardiac tissue) comprising: positioning at least one delivery electrode (38) of a catheter (12) in, on or near the target cardiac tissue area; coupling the catheter (12) with an energy modulator (catheter electrode distribution system (CEDS) 16), wherein the energy modulator comprises a component network (CEDS processing circuitry 62 and associated parts) disposed within the energy modulator (16) and arranged to pass voltages to adjacent output pins leading out of the energy modulator ([0061], “The system 10 may generally include a medical device 12 that may be coupled directly to an energy supply, such as a pulsed electric field or radiofrequency (RF) generator 14 including an energy control, delivering, and monitoring system or indirectly through a catheter electrode distribution system 16 (CEDS).” See [0072] for CEDS delivery relays 58 b which read on ‘pins’); coupling the energy modulator (16) to a signal generator (14), wherein the energy modulator is configured to fit between the catheter and the signal generator (Fig. 1), wherein the component network is further configured to regulate a voltage differential across the adjacent pins ([0078], “the generator 14 and/or CEDS 16 may be configured to execute an HV supply voltage check, a charge pre-check, and one or more pathway integrity checks.”), and wherein the component network is configured to modulate energy flowing from the generator to the electrodes ([0090]; also see [0082]-[0090]); and delivering pulsed electric field energy through the energy modulator (16) and the at least one delivery electrode (38) so as to treat the target cardiac tissue area in a non-thermal manner due to the energy modulator ([0004]; [0061]; [0068], electroporation); wherein the component network (CEDS processing circuitry 62 and associated parts) of the energy modulator (CEDS 16) allows the use of a non-thermal treatment because it is configured to maintain a voltage differential between adjacent output pins (58b) leading out of the energy modulator (16) below a predetermined threshold value ([0012], comparison of first and second voltages to a threshold voltage, “the first and second voltages being different” and “determining that that there is a connection fault condition in only a first wire of a thermocouple from which a recorded thermocouple voltage is greater than the first threshold voltage,” therefore, the voltage differential must be below a predetermined threshold value for operation; see [0067], for predetermined safety thresholds).
Regarding claim 14, Fraasch discloses wherein treating the target tissue area comprises creating at least one lesion to treat an arrhythmia (see [0004] for treating arrhythmias with pulsed RF energy).
Regarding claim 34, Fraasch discloses wherein the voltage differential across the adjacent pins (i.e., relays) is the same as a voltage differential between conductive wires in the catheter. It naturally follows that the signals from the relays carry to the conductive wires in the catheter to the electrodes, thereby maintain the same voltage differential between conductive wires in the catheter.
Regarding claim 35, Fraasch discloses wherein the energy modulator (16) is separate from and connectable to both the signal generator (14) and to the catheter (12). As broadly claimed, all of the components of the device are separable and connected.
Regarding claim 36, Fraasch discloses wherein the energy modulator (16) is electrically coupled to the catheter (12) by a cable (see cable (not labeled) in Fig. 1 exiting CEDS 16 to catheter 12).
Regarding claim 47, Fraasch discloses wherein the energy modulator (16) is configured to split the voltages output from the signal generator (14) such that the delivery electrode (38) receives a higher voltage while maintaining lower voltages at additional conductive elements of the catheter, thereby preventing arcing between the conductive elements by keeping the voltage differential below a predetermined threshold ([0012], comparison of first and second voltages to a threshold voltage, “the first and second voltages being different” and “determining that that there is a connection fault condition in only a first wire of a thermocouple from which a recorded thermocouple voltage is greater than the first threshold voltage,” therefore, the voltage differential must be below a predetermined threshold value for operation; see [0067], for predetermined safety thresholds).
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 5, 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Fraasch in view of Fraasch.
Regarding claim 5, Fraasch discloses all of the limitations of the method according to claim 1, but is silent regarding wherein pulsed electric field energy has a voltage of at least 2000 volts. However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the pulsed electric field energy as taught by Fraasch such that the pulsed electric field energy has a voltage of at least 2000 volts, 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 37, Fraasch discloses all of the limitations of the method according to claim 1, but is silent regarding wherein the pulsed electric field energy has a voltage of at least 2000 volts, wherein the catheter connected to the energy modulator is designed to deliver thermal energy having a voltage up to 1000 volts, and wherein the energy modulator maintains a maximum voltage differential of 1500 volts between conductive wires within the catheter to facilitate delivery of pulsed electric field energy through the catheter.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Fraasch such that the pulsed electric field energy has a voltage of at least 2000 volts, wherein the catheter connected to the energy modulator is designed to deliver thermal energy having a voltage up to 1000 volts, and wherein the energy modulator maintains a maximum voltage differential of 1500 volts between conductive wires within the catheter to facilitate delivery of pulsed electric field energy through the catheter, 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 38, Fraasch discloses all of the limitations of the method according to claim 1. Although Fraasch discloses wherein the catheter connected to the energy modulator is designed to deliver thermal energy ([0004], RF energy), Fraasch is silent regarding the thermal energy having a voltage up to 1000 volts.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Fraasch such that the thermal energy having a voltage up to 1000 volts, 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.
Claims 6, 26-29 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Fraasch in view of Eggers et al., (hereinafter ‘Eggers’, U.S. Pat. 7,445,618).
Regarding claim 6, Fraasch discloses all of the limitations of the method according to claim 1. Although Fraasch discloses wherein the at least one electrode (38) comprises at least two electrodes (see plurality of electrodes 38 designated with “+” or “-“ in Figs. 1 and 2), Fraasch is silent regarding wherein the at least one electrode comprises at least two electrodes each connected to individual conductive wires, wherein the energy modulator maintains a voltage differential between the individual conductive wires below a predetermined threshold voltage differential that causes arcing or shorting between the individual conductive wires.
However, in the same field of endeavor, Eggers (Figs. 1-2) teaches a similar method for tissue ablation using pulsed energy comprising a probe (10) including an array of electrode terminals (58) each connected to individual conductive wires and electrically isolated from one another. Eggers teaches, “[t]he power source will be current limited or otherwise controlled so that undesired heating of electrically conductive fluids or other low electrical resistance tissues does not occur... a current limiting resistor may be selected having a large positive temperature coefficient of resistance so that, as the current level begins to rise for any individual electrode in contact with a low resistance medium (e.g., saline irrigant), the resistance of the current limiting resistor increases significantly, thereby minimizing the power delivery from said electrode into the low resistance medium (e.g., saline irrigant). Thus, the electrode terminal sees a relatively constant current source so that power dissipation through a low resistance path, e.g., normal saline irrigant, will be substantially diminished” (col. 8, line 66 - col. 9, line 18; see Figs. 16 and 16A). It is well known in the art (as can be seen in Eggers) to provide a current limiter, such as a current limiting resistor, in order to provide a relatively constant current source so that power dissipation through a low resistance path, e.g., normal saline irrigant, will be substantially diminished” (col. 8, line 66 - col. 9, line 18), thereby avoiding arcing or shorting between the individual conductive wires. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Fraasch to include wherein the at least one electrode comprises at least two electrodes each connected to individual conductive wires, wherein the energy modulator maintains a voltage differential between the individual conductive wires below a predetermined threshold voltage differential that causes arcing or shorting between the individual conductive wires, as taught by Eggers. Doing so provides a relatively constant current source so that power dissipation through a low resistance path, e.g., normal saline irrigant, will be substantially diminished (col. 8, line 66 - col. 9, line 18), thereby increasing safety and control.
Regarding claims 26-28, Fraasch discloses all of the limitations of the method according to claim 1. Although Fraasch discloses wherein the catheter (12) comprises at least two electrodes (see plurality of electrodes 38 designated with “+” or “-“ in Figs. 1 and 2), Fraasch is silent regarding wherein the energy modulator comprises at least one passive component, wherein the at least one passive component comprises at least one resistor, the method further comprising selecting resistor value(s) for at least one of the at least one resistor, and wherein the catheter comprises at least two electrodes each connected to individual conductive wires, further comprising selecting at least one resistor value that maintain a voltage differential between the individual conductive wires below a predetermined threshold voltage differential that causes arcing between the individual conductive wires.
However, in the same field of endeavor, Eggers (Figs. 1-2) teaches a similar method for tissue ablation using pulsed energy comprising a probe (10) including an array of electrode terminals (58) each connected to individual conductive wires and electrically isolated from one another. Eggers teaches, “[t]he power source will be current limited or otherwise controlled so that undesired heating of electrically conductive fluids or other low electrical resistance tissues does not occur... a current limiting resistor may be selected having a large positive temperature coefficient of resistance so that, as the current level begins to rise for any individual electrode in contact with a low resistance medium (e.g., saline irrigant), the resistance of the current limiting resistor increases significantly, thereby minimizing the power delivery from said electrode into the low resistance medium (e.g., saline irrigant). Thus, the electrode terminal sees a relatively constant current source so that power dissipation through a low resistance path, e.g., normal saline irrigant, will be substantially diminished” (col. 8, line 66 - col. 9, line 18; see Figs. 16 and 16A). It is well known in the art (as can be seen in Eggers) to provide a passive current limiter, such as a current limiting resistor, in order to provide a relatively constant current source so that power dissipation through a low resistance path, e.g., normal saline irrigant, will be substantially diminished” (col. 8, line 66 - col. 9, line 18), thereby avoiding arcing or shorting between the individual conductive wires. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Fraasch to include wherein the energy modulator comprises at least one passive component, wherein the at least one passive component comprises at least one resistor, the method further comprising selecting resistor value(s) for at least one of the at least one resistor, and wherein the catheter comprises at least two electrodes each connected to individual conductive wires, further comprising selecting at least one resistor value that maintain a voltage differential between the individual conductive wires below a predetermined threshold voltage differential that causes arcing between the individual conductive wires, as taught by Eggers. Doing so provides a relatively constant current source so that power dissipation through a low resistance path, e.g., normal saline irrigant, will be substantially diminished (col. 8, line 66 - col. 9, line 18), thereby increasing safety and control.
Regarding claim 29, Fraasch discloses all of the limitations of the method according to claim 1, but is silent regarding positioning an external return electrode electrically coupleable with the signal generator on the patient and wherein the catheter delivers the pulsed electric field energy in a monopolar fashion with the external return electrode
However, in the same field of endeavor, Eggers teaches a similar method for tissue ablation using pulsed energy. Eggers teaches that, “[e]lectrosurgical procedures usually operate through the application of very high frequency currents to cut or ablate tissue structures, where the operation can be monopolar or bipolar. Monopolar techniques rely on external grounding of the patient, where the surgical device defines only a single electrode pole” (col. 1, ll. 34-41). It is well known in the art (as can be seen in Eggers) that an external return electrode is typically provided for the application of pulsed electric field energy in a monopolar fashion in order to provide a return path for the applied energy, thereby increasing safety and control. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Fraasch to include positioning an external return electrode electrically coupleable with the signal generator on the patient and wherein the catheter delivers the pulsed electric field energy in a monopolar fashion with the external return electrode, as taught by Eggers in order to provide a return path for the applied energy, thereby increasing safety and control.
Regarding 48, Fraasch discloses all of the limitations of the method according to claim 1, but is silent regarding further comprising modulating the voltage levels delivered to the at least one delivery electrode through a component network within the energy modulator, wherein the modulation allows for balancing the distribution of energy delivered across the catheter while ensuring that the voltage differential between any two conductive wires remains below a predetermined safety threshold during therapy.
However, in the same field of endeavor, Eggers (Figs. 1-2) teaches a similar method for tissue ablation using pulsed energy comprising a probe (10) including an array of electrode terminals (58) each connected to individual conductive wires and electrically isolated from one another. Eggers teaches “the power source and controller 28 provides high frequency voltage to the electrode terminals 28 (of FIG. 2) by means of a cable 24 from connector 20 in handle 22 to receptacle 26, the power source and controller 28. The power source and controller 28 has a selector 30 to change the applied voltage level.” (col. 10, ll. 46-59, thereby meeting the limitation of modulating the voltage levels delivered to the at least one delivery electrode through a component network within the energy modulator). Eggers teaches, “[t]he power source will be current limited or otherwise controlled so that undesired heating of electrically conductive fluids or other low electrical resistance tissues does not occur... a current limiting resistor may be selected having a large positive temperature coefficient of resistance so that, as the current level begins to rise for any individual electrode in contact with a low resistance medium (e.g., saline irrigant), the resistance of the current limiting resistor increases significantly, thereby minimizing the power delivery from said electrode into the low resistance medium (e.g., saline irrigant). Thus, the electrode terminal sees a relatively constant current source so that power dissipation through a low resistance path, e.g., normal saline irrigant, will be substantially diminished” (col. 8, line 66 - col. 9, line 18; see Figs. 16 and 16A). It is well known in the art (as can be seen in Eggers) to modulate voltage and to limit current in order to avoid arcing or shorting between the individual conductive wires. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Fraasch to include modulating the voltage levels delivered to the at least one delivery electrode through a component network within the energy modulator, wherein the modulation allows for balancing the distribution of energy delivered across the catheter while ensuring that the voltage differential between any two conductive wires remains below a predetermined safety threshold during therapy, as taught by Eggers, in order to avoid arcing or shorting between the individual conductive wires, thereby increasing safety and control.
Claims 7-13, and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Fraasch in view of Martin et al., (hereinafter 'Martin', U.S. PGPub. No. 2013/0336356).
Regarding claim 7, Fraasch discloses all of the limitations of the method according to claim 1. Although Fraasch further discloses a method of detecting a fault condition to control and modify energy delivery ([0082]-[0090]), Fraasch is silent regarding comprising providing information that is used to adjust at least one aspect of the energy modulator so as to select a higher energy level based on the information.
However, in the same field of endeavor, Martin teaches a method of detecting a thermocouple short circuit or channel fault in a medical device (abstract, [0018]; medical device 12 and system 10 in Fig. 1-5) wherein a short “can be caused by a breakdown in the insulative barrier between individual conductors intended to be isolated. In addition, shorts can occur not only between multiple thermocouples, but also within a thermocouple consisting of a pair of wires” ([0005]). The device (12 in Fig. 1) includes one or more electrically-conductive segments or electrode (34 in Fig. 1) wherein each electrode (34) may include one or more thermocouples (37) integral to or otherwise coupled to each electrode (34) ([0024]). The sensors (thermocouples) are in communication with a control unit (14) for “initiating or triggering one or more alerts or therapeutic delivery modifications during operation of the medical device 12” and may further include “one or more controllers, processors, and/or software modules containing instructions or algorithms to provide for the automated operation and performance of the features, sequences, calculations, or procedures described herein” ([0034]). Martin further teaches an exemplary method for detecting and indicating a thermocouple short circuit or channel fault in conjunction with treatment or diagnosis of a tissue site through operation of the medical device (12) and the control unit (14) ([0036]). The processing circuitry (described above within control unit 14) is further configured to determine whether there is a connection fault condition in at least one of the first and second wire of the thermocouple (see [0036]-[0037], the control unit 14 will generate an indication of a thermocouple short circuit based at least in part of the comparison of the calculated rate of change over time to a predefined rate of change over time threshold). Further, “thermocouples are often employed in proximity to a treatment region to provide the desired feedback to regulate power delivery” ([0004]), therefore, this fault condition is utilized in order to determine if energy delivery should be modified and/or terminated to a particular electrode associated with the thermocouple indicating a fault ([0040]), thereby improving delivery and control of the proper amount of treatment energy to a treatment site ([0004]) and increasing therapeutic success rates ([0004]). As such, Martine teaches further comprising providing information that is used to adjust at least one aspect of the energy modulator so as to select the higher energy level based on the information. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Fraasch to include providing information that is used to adjust at least one aspect of the energy modulator so as to select a higher energy level based on the information, as taught by Martin. Doing so allows the user to modify and/or terminate energy to a particular electrode associated with the thermocouple indicating a fault ([0040]), thus allowing prolonged use of the device due to the energy modulator, and thereby improving delivery and control of the proper amount of treatment energy to a treatment site ([0004]) and increasing therapeutic success rates ([0004]).
Regarding claim 8, Fraasch in view of Martin teach all of the limitations of the method according to claim 7. In view of the prior modification of Fraasch in view of Martin, Martin teaches wherein providing information comprises providing at least one parameter of the pulsed electric field energy (see [0034], for system 10 including one or more sensors to monitor the operating parameters throughout the system, including for example, pressure, temperature, flow rates, volume, power delivery, impedance, or the like in the control unit 14 and/or the medical device 12. The sensor(s) may be in communication with the control unit 14 for initiating or triggering one or more alerts or therapeutic delivery modifications during operation of the medical device 12).
Regarding claim 9, Fraasch in view of Martin teach all of the limitations of the method according to claim 8. In view of the prior modification of Fraasch in view of Martin, Martin teaches wherein the at least one parameter of the pulsed electric field energy comprises voltage, current, frequency, waveform shape, duration, rising pulse time, falling pulse time and/or amplitude of the energy (see [0034], for parameters including power delivery, impedance, or the like in the control unit 14 and/or the medical device 12).
Regarding claim 10, Fraasch in view of Martin teach all of the limitations of the method according to claim 7. In view of the prior modification of Fraasch in view of Martin, Martin teaches wherein providing information comprises providing at least one feature of the catheter (as broadly claimed, the information regarding a fault condition of the system necessarily meets the limitation regarding providing at least one feature of the catheter).
Regarding claim 11, Fraasch in view of Martin teach all of the limitations of the method according to claim 10. Fraasch further discloses wherein the at least one feature of the catheter comprises number of electrodes, a dimension of the electrodes, a distance between the electrodes, a brand of the catheter, a model of the catheter, a type of thermal energy the catheter is configured for or a combination of any of these ([0067], “generator 14 may include processing circuitry 44, including a processor and a memory, in communication with one or more controllers and/or memories containing software modules containing instructions or algorithms to provide for the automated operation and performance of the features, sequences, calculations, or procedures described herein and/or required for a given medical procedure”).
Regarding claim 12 and 13, Fraasch in view of Martin teach all of the limitations of the method according to claim 7. In view of the prior modification of Fraasch in view of Martin, Martin teaches wherein providing information comprises providing an aspect of the environment of the target cardiac tissue area, wherein the at least one aspect of the environment comprises cell type(s), conductivity, voltage distribution, impedance, temperature, and/or blood flow ([0034], “system 10 may further include one or more sensors to monitor the operating parameters throughout the system, including for example, pressure, temperature, flow rates, volume, power delivery, impedance, or the like in the control unit 14 and/or the medical device 12, in addition to monitoring, recording or otherwise conveying measurements or conditions within the medical device 12 or the ambient environment at the distal portion of the medical device 12”).
Regarding claim 30, Fraasch in view of Martin teach all of the limitations of the method according to claim 1. Fraasch (Fig. 1) further discloses coupling the catheter (12) with an interface connector (CEDS 16) that electrically couples the catheter to both the signal generator (14) and an electroanatomic mapping system ([0062]; [0064]), wherein the interface connector (16) prevents the at least one electrode from electrically communicating with both the signal generator and the electroanatomic mapping system simultaneously ([0064], “catheter electrode energy distribution system 16 may include high speed relays to disconnect/reconnected specific electrodes 38 from the generator 14 during an energy delivery procedure. Immediately following the pulsed energy deliveries, the relays may reconnect the electrode(s) 38 so they may be used for diagnostic purposes.”).
Regarding claim 31, Fraasch in view of Martin teach all of the limitations of the method according to claim 30. Fraasch (Fig. 1) further discloses wherein the interface connector (16) includes a switching system (i.e. relays) comprising a first path of at least one conductive wire between the at least one electrode and the signal generator and a second path of at least one conductive wire between the at least one electrode and the electroanatomic mapping system, wherein the switching system toggles the energy transmission between the first path and the second path ([0064], “catheter electrode energy distribution system 16 may include high speed relays to disconnect/reconnected specific electrodes 38 from the generator 14 during an energy delivery procedure. Immediately following the pulsed energy deliveries, the relays may reconnect the electrode(s) 38 so they may be used for diagnostic purposes”).
Regarding claim 32, Fraasch in view of Martin teach all of the limitations of the method according to claim 30. Fraasch (Fig. 1) further discloses wherein coupling the catheter (12) with an energy modulator (catheter electrode distribution system (CEDS) 16, CEDS processing circuitry 62) includes operatively connecting the catheter (12) with the signal generator (16) in a manner so that the signal generator (16) is able to measure, sense or identify at least one aspect of the catheter (see [0064]; as broadly claimed, the CEDS 16 and associated processing circuitry 62 is able to identify the mode of the catheter).
Regarding claim 33, Fraasch in view of Martin teach all of the limitations of the method according to claim 30. Fraasch (Fig. 1) further discloses wherein the catheter comprises at least two electrodes (38) each connected to a conductive wire and the energy modulator (catheter electrode distribution system (CEDS) 16, CEDS processing circuitry 62) applies a desired resistance to each conductive wire of the catheter (12), wherein each desired resistance is chosen based on the at least one aspect (see [0064]; as broadly claimed, the CEDS 16 and associated processing circuitry 62 is able to identify the mode of the catheter, i.e. ablation or mapping, and would necessarily apply a desired resistance to each conductive wire of the catheter accordingly).
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Fraasch in view of Mody et al., (hereinafter ‘Mody’, U.S. PGPub. No. 2007/0219546).
Regarding claim 15, Fraasch discloses all of the limitations of the method according to claim 14, but are silent regarding wherein the at least one lesion comprises a plurality of lesions positioned sufficiently around an entry of a pulmonary vein in an atrium of a heart of the patient so as to create a conduction block between the pulmonary vein and the atrium.
However, in the same field of endeavor, Mody (Figs. 1 and 6A-6D) teaches a similar method for creating lesions in various anatomical regions, such as the heart, in order to treat cardiac arrhythmias (abstract). Mody further teaches, “any of the ablation devices or ablation systems disclosed herein may be adapted to be inserted into the left atrium 106 through a transseptal sheath or introducer to perform a procedure in the left atrium 106” ([0185]). As best illustrated in Figure 6A, a first ablation (A1) may be provided to encircle the left superior pulmonary vein (110) so as to create a conduction block between the pulmonary vein and the atrium. After the initial ablation, the ablating portion (20) is then advanced to engage the target tissue at the next desired location (Figs. 6A- 6D), ultimately forming a continuous lesion (as best illustrated in Fig. 6D). It is well known in the art (as can be seen in Mody) to provide a plurality of intersecting lesions in order to provide at least two barriers or conduction block lines to the passing of undesirable signals, thereby better ensuring the creation of the desired conduction block ([0149]; [0189]) and increasing safety and efficiency. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Fraasch to include wherein the at least one lesion comprises a plurality of lesions positioned sufficiently around an entry of a pulmonary vein in an atrium of a heart of the patient so as to create a conduction block between the pulmonary vein and the atrium, as taught by Mody. Doing so provides a plurality of intersecting lesions in order to provide at least two barriers or conduction block lines to the passing of undesirable signals, thereby better ensuring the creation of the desired conduction block ([0149]; [0189]) and increasing safety and efficiency.
Regarding claim 16, Fraasch discloses all of the limitations of the method according to claim 14, but is silent regarding wherein the at least one lesion comprises a single lesion extending sufficiently around an entry of a pulmonary vein in an atrium of a heart of the patient so as to create a conduction block between the pulmonary vein and the atrium.
However, in the same field of endeavor, Mody (Figs. 1 and 6A-6D) teaches a similar method for creating lesions in various anatomical regions, such as the heart, in order to treat cardiac arrhythmias (abstract). Mody further teaches, “any of the ablation devices or ablation systems disclosed herein may be adapted to be inserted into the left atrium 106 through a transseptal sheath or introducer to perform a procedure in the left atrium 106” ([0185]). As best illustrated in Figure 6A, a first ablation (A1) may be provided to encircle the left superior pulmonary vein (110) so as to create a conduction block between the pulmonary vein and the atrium in order to eliminate the passing of undesirable signals, thereby increasing safety. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Fraasch to include a single lesion extending sufficiently around an entry of a pulmonary vein in an atrium of a heart of the patient so as to create a conduction block between the pulmonary vein and the atrium as taught by Mody in order to eliminate the passing of undesirable signals, thereby increasing safety.
Claim 39 is rejected under 35 U.S.C. 103 as being unpatentable over Fraasch in view of Byrd (hereinafter ‘Byrd,’ WO 2018/208795).
Regarding claim 39, Fraasch discloses all of the limitations of the method according to claim 1, but are silent regarding wherein the component network includes one or more capacitors.
However, in the same field of endeavor, Byrd teaches a similar method and system comprising a variable impedance (27) that includes “one or more impedance elements, such as resistors, capacitors, or inductors (not shown) connected in series, parallel, or combinations of series and/or parallel.” ([0028]). By providing these components, the impedance of the system can be varied to limit arcing from the catheter electrode of catheter, and can be used to change one or more characteristics, such as amplitude, duration, pulse shape, and the like, of an output of electroporation generator. Therefore, it would have been obvious to one having ordinary skill in the art to have modified the method as taught by Fraasch to include wherein the component network includes one or more capacitors, as taught by Byrd. By providing these components, the impedance of the system can be varied to limit arcing from the catheter electrode of catheter, and can be used to change one or more characteristics, such as amplitude, duration, pulse shape, and the like, of an output of electroporation generator, thereby improving safety and control.
Claims 40, 43 and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Byrd.
Regarding claim 40, Byrd (Fig. 1) discloses a method of treating a target cardiac tissue area of a patient comprising: positioning at least one delivery electrode of a plurality of delivery electrodes of a catheter (electrode assembly 12) in, on or near the target cardiac tissue area (tissue 16 in Fig. 1), wherein the catheter (14) is configured for delivery of thermal energy which is defined as energy having a voltage up to 1000 volts and has conduction wires that electrically connect to the plurality of delivery electrodes ([0026], “In some embodiments, electroporation generator 26 outputs a DC pulse having a peak magnitude of about between about negative 1.5 kV and about negative 2.0 kV. Other embodiments may output any other suitable voltage, including a positive voltage,” see [0035] for voltages in the range of thousands); coupling the catheter (14) with an energy modulator (27) that is external to the catheter (14), wherein the energy modulator (27) is configured to modulate the energy flowing from a waveform generator (26) to the catheter (14) to permit delivery of energy having a voltage greater than 1000 volts by steering the energy through the conduction wires in a manner so that voltage differentials between the conduction wires stay below a predetermined threshold value ([0027] – [0029], thereby limiting arcing); and delivering pulsed electric field energy through the energy modulator (27) and the at least one delivery electrode (12) so as to treat the target cardiac tissue area in a non-thermal manner due to operation of the energy modulator maintaining a voltage differential between conduction wires electrically connected to the plurality of delivery electrodes below the predetermined threshold value ([0027] – [0029], see [0028], “A variable impedance 27 allows the impedance of the system to be varied to limit arcing from the catheter electrode of catheter 14. Moreover, variable impedance 27 may be used to change one or more characteristics, such as amplitude, duration, pulse shape, and the like, of an output of electroporation generator 26.”), wherein the pulsed electric field energy comprises energy over a predetermined voltage level (as broadly claimed, energy could be delivered at a level that would cause arcing, but for the variable impedance 27).
Byrd is silent regarding the predetermined voltage level comprising 1000-1500 volts.
However, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the predetermined voltage level as taught by Byrd such that the predetermined voltage level comprising 1000-1500 volts, 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.
Regarding claim 43, Byrd discloses wherein the energy modulator (27) comprises a standalone device that is coupled to the catheter (14) with a cable (Fig. 1).
Regarding claim 44, Byrd discloses wherein the energy modulator comprises a component network comprised of passive components that modulate the energy flowing from the waveform generator to the at least one electrode ([0028], “Variable impedance 27 includes one or more impedance elements, such as resistors, capacitors, or inductors (not shown) connected in series, parallel, or combinations of series and/or parallel.”).
Claims 41, 42 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Byrd in view of Waldstreicher et al., (hereinafter ‘Waldstreicher,’ U.S. PGPub. No. 2019/0201089).
Regarding claim 41, although Byrd discloses treating the cardiac tissue with electroporation, Byrd is silent wherein the step of treating the target cardiac tissue area in the non-thermal manner comprises forming at least one lesion in the target cardiac tissue area while ensuring a temperature of the target cardiac tissue area remains below a temperature threshold for thermal ablation.
However, in the same field of endeavor, Waldstreicher teaches a similar method and device comprising temperature sensors to monitor the temperature of the tissue during treatment. Waldstreicher teaches, “one or more temperature sensors monitor the temperature of the tissue and/or electrode, and if a pre-defined threshold temperature is exceeded (e.g., 65° C.), the generator 104 alters the algorithm to automatically cease energy deliver. For example, if the safety threshold is set at 65° C. and the generator 104 receives the feedback from the one or more temperature sensors that the temperature safety threshold is being exceeded, the treatment can be stopped automatically.” ([0364]). This configuration reduces the likelihood of undesirable heating and thermal damage, thereby improving control and patient safety. Therefore, it would have been obvious to one having ordinary skill in the art to have modified the method as taught by Byrd to include wherein the step of treating the target cardiac tissue area in the non-thermal manner comprises forming at least one lesion in the target cardiac tissue area while ensuring a temperature of the target cardiac tissue area remains below a temperature threshold for thermal ablation, as taught Waldstreicher. Doing so reduces the likelihood of undesirable heating and thermal damage, thereby improving control and patient safety.
Regarding claim 42, Byrd in view of Waldstreicher teach all of the limitation of the method according to claim 41. In view of the prior modification of Byrd in view of Waldstreicher, Waldstreicher teaches wherein the temperature threshold for thermal ablation is 65° C ([0364], “For example, if the safety threshold is set at 65° C.”).
Regarding claim 45, Byrd discloses all of the limitations of the method according to claim 40, but is silent regarding wherein the target cardiac tissue is heated such that a temperature of the target cardiac tissue area remains between 30-65° C.
However, in the same field of endeavor, Waldstreicher teaches a similar method and device comprising temperature sensors to monitor the temperature of the tissue during treatment. Waldstreicher teaches, “one or more temperature sensors monitor the temperature of the tissue and/or electrode, and if a pre-defined threshold temperature is exceeded (e.g., 65° C.), the generator 104 alters the algorithm to automatically cease energy deliver. For example, if the safety threshold is set at 65° C. and the generator 104 receives the feedback from the one or more temperature sensors that the temperature safety threshold is being exceeded, the treatment can be stopped automatically.” ([0364]). This configuration reduces the likelihood of undesirable heating and thermal damage, thereby improving control and patient safety. Here, the tissue would not exceed 65° C. Therefore, it would have been obvious to one having ordinary skill in the art to have modified the method as taught by Byrd to include wherein the target cardiac tissue is heated such that a temperature of the target cardiac tissue area remains between 30-65° C, as taught Waldstreicher. Doing so reduces the likelihood of undesirable heating and thermal damage, thereby improving control and patient safety.
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Fraasch in view of Stewart et al., (hereinafter ‘Stewart,’ U.S. Pat. 10,531,914).
Regarding claim 46, Fraasch discloses all of the limitations of the method according to claim 1, but is silent regarding wherein the delivery of pulsed electric field energy is performed in a monopolar configuration, utilizing only a single delivery electrode of the catheter, with an external return electrode positioned on the skin of the patient to enable efficient energy flow towards the target cardiac tissue.
However, in the same field of endeavor, Stewart teaches a similar method for ablating tissue by applying at least one pulse train of pulsed-field energy (abstract). The generator (14) may be configured to provide energy to an individual electrode of the plurality of electrodes (24) or multiple electrodes of the plurality of electrodes (24) of the medical device (12) (col. 6, ll. 4-8). Further, Stewart teaches “[t]he generator 14 may be operable in one or more modes of operation, including for example: (i) bipolar energy delivery between at least two electrodes 24 or electrically-conductive portions of the medical device 12 within a patient's body, (ii) monopolar or unipolar energy delivery to one or more of the electrodes or electrically-conductive portions on the medical device 12 within a patient's body and through either a second device within the body (not shown) or a patient return or ground electrode (not shown) spaced apart from the plurality of electrodes 24 of the medical device 12, such as on a patient's skin … and (iii) a combination of the monopolar and bipolar modes.” (col. 6, ll. 8-22). These different modes of operation (as can be seen in Stewart) are widely considered well known and interchangeable modes of operation to achieve a predictable result. Therefore, it would have been obvious to one having ordinary skill in the art to have modified the method as taught by Fraasch to provide wherein the delivery of pulsed electric field energy is performed in a monopolar configuration, utilizing only a single delivery electrode of the catheter, with an external return electrode positioned on the skin of the patient to enable efficient energy flow towards the target cardiac tissue, as taught by Stewart, “in order to effectuate a physiological modification (i.e., permeabilization) of the cells to which the energy is applied … without long duration of electrical current flow that results in significant tissue heating and muscle stimulation.” (col. 6, ll. 23-43, thereby increasing control and safety). Further, this modification would have merely comprised a simple substitution of one known mode of operation for another in order to obtain a predictable result.
Claims 49 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Byrd in view of Stewart.
Regarding claim 49, Byrd discloses all of the limitations of the method according to claim 40. Although Byrd discloses the electrodes may be selectively coupled ([0027]), Byrd is silent regarding wherein the delivery of pulsed electric field energy is performed in a monopolar configuration, utilizing only a single delivery electrode of the catheter, with an external return electrode positioned on the skin of the patient to enable efficient energy flow towards the target cardiac tissue.
However, in the same field of endeavor, Stewart teaches a similar method for ablating tissue by applying at least one pulse train of pulsed-field energy (abstract). The generator (14) may be configured to provide energy to an individual electrode of the plurality of electrodes (24) or multiple electrodes of the plurality of electrodes (24) of the medical device (12) (col. 6, ll. 4-8). Further, Stewart teaches “[t]he generator 14 may be operable in one or more modes of operation, including for example: (i) bipolar energy delivery between at least two electrodes 24 or electrically-conductive portions of the medical device 12 within a patient's body, (ii) monopolar or unipolar energy delivery to one or more of the electrodes or electrically-conductive portions on the medical device 12 within a patient's body and through either a second device within the body (not shown) or a patient return or ground electrode (not shown) spaced apart from the plurality of electrodes 24 of the medical device 12, such as on a patient's skin … and (iii) a combination of the monopolar and bipolar modes.” (col. 6, ll. 8-22). These different modes of operation (as can be seen in Stewart) are widely considered well known and interchangeable modes of operation to achieve a predictable result. Therefore, it would have been obvious to one having ordinary skill in the art to have modified the method as taught by Byrd to provide wherein the delivery of pulsed electric field energy is performed in a monopolar configuration, utilizing only a single delivery electrode of the catheter, with an external return electrode positioned on the skin of the patient to enable efficient energy flow towards the target cardiac tissue, as taught by Stewart, “in order to effectuate a physiological modification (i.e., permeabilization) of the cells to which the energy is applied … without long duration of electrical current flow that results in significant tissue heating and muscle stimulation.” (col. 6, ll. 23-43, thereby increasing control and safety). Further, this modification would have merely comprised a simple substitution of one known mode of operation for another in order to obtain a predictable result.
Regarding claim 50, Byrd discloses all of the limitations of the method according to claim 40, but is silent regarding wherein the energy modulator is configured to split the voltages output from the signal generator such that the delivery electrode receives a higher voltage while maintaining lower voltages at additional conductive elements of the catheter, thereby preventing arcing between the conductive elements by keeping the voltage differential below a predetermined threshold.
However, in the same field of endeavor, Stewart teaches a similar method for ablating tissue by applying at least one pulse train of pulsed-field energy (abstract). The generator (14) may be configured to provide energy to an individual electrode of the plurality of electrodes (24) or multiple electrodes of the plurality of electrodes (24) of the medical device (12) (col. 6, ll. 4-8). Further, Stewart teaches “[t]he generator 14 may be operable in one or more modes of operation, including for example: (i) bipolar energy delivery between at least two electrodes 24 or electrically-conductive portions of the medical device 12 within a patient's body, (ii) monopolar or unipolar energy delivery to one or more of the electrodes or electrically-conductive portions on the medical device 12 within a patient's body and through either a second device within the body (not shown) or a patient return or ground electrode (not shown) spaced apart from the plurality of electrodes 24 of the medical device 12, such as on a patient's skin … and (iii) a combination of the monopolar and bipolar modes.” (col. 6, ll. 8-22). Therefore, when operated in the monopolar mode, the delivery electrode receives a higher voltage while maintaining lower voltages at additional conductive elements of the catheter, thereby preventing arcing between the conductive elements by keeping the voltage differential below a predetermined threshold. Therefore, it would have been obvious to one having ordinary skill in the art to have modified the method as taught by Byrd to provide wherein the energy modulator is configured to split the voltages output from the signal generator such that the delivery electrode receives a higher voltage while maintaining lower voltages at additional conductive elements of the catheter, as taught by Stewart, “in order to effectuate a physiological modification (i.e., permeabilization) of the cells to which the energy is applied … without long duration of electrical current flow that results in significant tissue heating and muscle stimulation.” (col. 6, ll. 23-43, thereby increasing control and safety). Further, this modification would have merely comprised a simple substitution of one known mode of operation for another in order to obtain a predictable result.
Claim 51 is rejected under 35 U.S.C. 103 as being unpatentable over Byrd in view of Eggers.
Regarding claim 51, Byrd discloses all of the limitations of the method according to claim 40, but is silent regarding further comprising modulating the voltage levels delivered to the at least one delivery electrode through a component network within the energy modulator, wherein the modulation allows for balancing the distribution of energy delivered to the catheter while ensuring that the voltage differential between any two conductive wires remains below a predetermined safety threshold during therapy.
However, in the same field of endeavor, Eggers (Figs. 1-2) teaches a similar method for tissue ablation using pulsed energy comprising a probe (10) including an array of electrode terminals (58) each connected to individual conductive wires and electrically isolated from one another. Eggers teaches “the power source and controller 28 provides high frequency voltage to the electrode terminals 28 (of FIG. 2) by means of a cable 24 from connector 20 in handle 22 to receptacle 26, the power source and controller 28. The power source and controller 28 has a selector 30 to change the applied voltage level.” (col. 10, ll. 46-59, thereby meeting the limitation of modulating the voltage levels delivered to the at least one delivery electrode through a component network within the energy modulator). Eggers teaches, “[t]he power source will be current limited or otherwise controlled so that undesired heating of electrically conductive fluids or other low electrical resistance tissues does not occur... a current limiting resistor may be selected having a large positive temperature coefficient of resistance so that, as the current level begins to rise for any individual electrode in contact with a low resistance medium (e.g., saline irrigant), the resistance of the current limiting resistor increases significantly, thereby minimizing the power delivery from said electrode into the low resistance medium (e.g., saline irrigant). Thus, the electrode terminal sees a relatively constant current source so that power dissipation through a low resistance path, e.g., normal saline irrigant, will be substantially diminished” (col. 8, line 66 - col. 9, line 18; see Figs. 16 and 16A). It is well known in the art (as can be seen in Eggers) to modulate voltage and to limit current in order to avoid arcing or shorting between the individual conductive wires. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the method as taught by Fraasch to include modulating the voltage levels delivered to the at least one delivery electrode through a component network within the energy modulator, wherein the modulation allows for balancing the distribution of energy delivered across the catheter while ensuring that the voltage differential between any two conductive wires remains below a predetermined safety threshold during therapy, as taught by Eggers, in order to avoid arcing or shorting between the individual conductive wires, thereby increasing safety and control.
Response to Arguments
Applicant’s arguments with respect to claims 1, 5-16, and 26-51 have been considered but are moot because the amendment has necessitated a new ground of rejection.
Applicant’s arguments regarding the importance of voltage differentials for PEF delivery (pp. 10-12) are acknowledged, but are not found persuasive. Applicant has emphasized “ the critical nature of maintaining voltage differentials below a predetermined threshold in the operation of our pulsed electric field (PEF) energy delivery system, particularly in the context of catheters designed for thermal ablation but that are rendered capable of delivering PEF energy through application of the disclosed invention.” Applicant argues that Fraasch “does not disclose any mechanism or apparatus for actively maintaining voltage differentials below a predetermined value within an energy delivery catheter while performing therapeutic PEF energy delivery, particularly for the salient purpose of delivering PEF energy (relatively higher voltage) through a catheter originally designed for thermal energy delivery (relatively lower voltage).” Applicant also attempts to distinguish Fraasch in that the purpose of the reference is to determine if there is a fault condition and measure voltage differentials for the purpose of detecting faults in a system.
The Examiner acknowledges that the prior art Fraasch does discloses determining if there is a fault condition. Claim 1 of the instant application now recites, “wherein the component network of the energy modulator allows the use of a non-thermal treatment because it is configured to maintain a voltage differential between adjacent output pins leading out of the energy modulator below a predetermined threshold value.” It is the Examiner’s position that Fraasch teaches this limitation.
Fraasch teaches the method including the component network is configured to modulate energy flowing from the generator to the electrodes ([0090]; also see [0082]-[0090]); and delivering pulsed electric field energy through the energy modulator (16) and the at least one delivery electrode (38) so as to treat the target cardiac tissue area in a non-thermal manner due to the energy modulator ([0004]; [0061]; [0068], electroporation); wherein the component network (CEDS processing circuitry 62 and associated parts) of the energy modulator (CEDS 16) allows the use of a non-thermal treatment because it is configured to maintain a voltage differential between adjacent output pins (58b) leading out of the energy modulator (16) below a predetermined threshold value ([0012], comparison of first and second voltages to a threshold voltage, “the first and second voltages being different” and “determining that that there is a connection fault condition in only a first wire of a thermocouple from which a recorded thermocouple voltage is greater than the first threshold voltage,” therefore, the voltage differential must be below a predetermined threshold value for operation; see [0067], for predetermined safety thresholds).
Applicant has argued (p.11), “[r]eviewing the Fraasch reference cited in the office action, it is evident that it does not disclose any mechanism or apparatus for actively maintaining voltage differentials below a predetermined value within an energy delivery catheter while performing therapeutic PEF energy delivery, particularly for the salient purpose of delivering PEF energy (relatively higher voltage) through a catheter originally designed for thermal energy delivery (relatively lower voltage).” However, Fraasch does teach the voltage differential must be below a predetermined threshold value for operation. If a fault is detected and the threshold exceeded, operation is then ceased.
Similarly, regarding independent claim 40, Applicant has argued (pp. 14-15), “[w]hile Byrd discusses the modulation of energy and the limitation of arcing via variable impedance, it does not detail a mechanism for ensuring that the voltage differentials among the wires remain actively below a specific threshold during the delivery of pulsed electric field energy.” Further, Applicant argues “Byrd describes using a variable impedance to limit arcing, but it does not articulate whether this modulation translates into managing the ongoing voltage differentials between conduction wires specifically connected to delivery electrodes. Amended Claim 40 requires that the modulation ensures the voltage between these wires is consistently maintained below the threshold during the entire energy delivery process. Byrd does not provide the method for achieving this level of controlled maintenance throughout treatment, thus indicating its insufficiency as a basis for rejection.” It is the Examiner’s position that Byrd does teach the amendment. Byrd does provide a mechanism for ensuring that the voltage differentials among the wires remain actively below a specific threshold during the delivery of pulsed electric field energy.
In particular, Byrd discloses the energy modulator (27) is configured to modulate the energy flowing from a waveform generator (26) to the catheter (14) to permit delivery of energy having a voltage greater than 1000 volts by steering the energy through the conduction wires in a manner so that voltage differentials between the conduction wires stay below a predetermined threshold value ([0027] – [0029], thereby limiting arcing); and delivering pulsed electric field energy through the energy modulator (27) and the at least one delivery electrode (12) so as to treat the target cardiac tissue area in a non-thermal manner due to operation of the energy modulator maintaining a voltage differential between conduction wires electrically connected to the plurality of delivery electrodes below the predetermined threshold value ([0027] – [0029], see [0028], “A variable impedance 27 allows the impedance of the system to be varied to limit arcing from the catheter electrode of catheter 14. Moreover, variable impedance 27 may be used to change one or more characteristics, such as amplitude, duration, pulse shape, and the like, of an output of electroporation generator 26.”). It is the Examiner’s position that the energy modulator in combination with the other components of the device read on the mechanism Applicant argues. It is suggested that Applicant amend the claim to include further structure to distinguish the claims from the prior art.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references (p. 15), the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). The Examiner notes that Byrd is relied upon to teach the amendment in claim 40.
No further arguments have been set forth regarding the dependent claims.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/C.A.D./Examiner, Art Unit 3794