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 .
Priority
Examiner acknowledges priority filing date of 07/09/2021.
Continued Examination Under 37 CFR 1.114
Receipt is acknowledged of a request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) and a submission, filed on 07/31/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/31/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
Examiner acknowledges the amendments made to claims 1, 7-8, 10-12 and 14-16 with claims 9 and 13 cancelled in prosecution. Claims 1-8, 10-12, 14-20 are currently pending in prosecution.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-8, 11-12, 14, 16-20 is/are rejected under 35 U.S.C. 103 as being anticipated by Eyster (US Patent No 20210393327) in view of Sherman (US Patent No 20140066913).
Regarding claim 1, Eyster teaches a catheter (catheter 102, [0359])comprising: an elongated member extending along a longitudinal axis (elongate shaft 120, [0362], see also fig 2B); a tip electrode disposed over a distal end of the elongated member (see delivery electrode 122 disposed at the distal end of shaft 120, fig 2B) and being configured to provide radio frequency (RF) ablation electrical signals (configured to deliver therapeutic energies which consist of RF energy signals, [abstract], wherein the catheter can be configured to apply radiofrequency ablation, [0098]); a proximal ring electrode disposed on the elongated member about the longitudinal axis and disposed in a proximal direction in relation to the tip electrode (see fig 2B for ring electrode 125 which is disposed proximal the delivery electrode 122), and a middle ring electrode disposed on the elongated member and disposed in a proximal direction in relation to the tip electrode and a distal direction in relation to the proximal ring electrode (see fig 2B in which multiple ring electrodes 125 are called out, one electrode being more centralized in which it is proximal the delivery electrode 122 and distal the ring electrode 125).
Eyster does not explicitly teach that the catheter is configured to deliver biphasic pulse bursts having an amplitude of approximately 1800 V between the tip electrode and the proximal ring electrode in a bipolar configuration; the electrodes being configured to deliver biphasic pulse bursts having an amplitude of approximately 900 V between the middle ring electrode and the proximal ring electrode in a bipolar configuration and being configured to deliver biphasic pulse bursts having an amplitude of approximately 900 V between the middle ring electrode and the tip electrode in a bipolar configuration.
However, the analogous IRE and ablation catheter taught by Sherman does teach a catheter system which contains a distal tip electrode (see tip electrode 26A from fig 3A) and respective middle ring and proximal electrodes (see ring electrodes 26B and 26C for example from fig 3A) and that the catheter is configured to deliver biphasic pulse bursts having an amplitude of approximately 1800 V between the tip electrode and the proximal ring electrode in a bipolar configuration (see Sherman [0025] in which the electrodes are activated in a bipolar mode and in which the tip electrode 26A and the proximal electrode 26C are configured to apply energy between each other in the same phase, which is delivered at about 1000 V but can reach up to twice the voltage of 2000 V, therefore encompassing the claimed limitation of approximately 1800V); the electrodes being configured to deliver biphasic pulse bursts having an amplitude of approximately 900 V between the middle ring electrode and the proximal ring electrode in a bipolar configuration (see Sherman [0025] in which the electrodes are activated in a bipolar mode and in which the middle electrode 26B and the proximal electrode 26C are configured to apply energy between each other in the same phase, which is delivered at about 1000 V, which is seen as approximately 900V and therefore encompassing the claimed limitation of approximately 900V) and being configured to deliver biphasic pulse bursts having an amplitude of approximately 900 V between the middle ring electrode and the tip electrode in a bipolar configuration (see Sherman [0025] in which the electrodes are activated in a bipolar mode and in which the tip electrode 26A and the middle electrode 26B are configured to apply energy between each other in the same phase, which is delivered at about 1000 V, which is seen as approximately 900V and therefore encompassing the claimed limitation of approximately 900V).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the catheter system taught by Eyster with that of the bipolar modal catheter system configured to deliver biphasic pulses at a specified voltages between the distal and proximal electrodes taught by Sherman, as the specified voltages and biphasic pulses are known quantities and methods in the art for achieving ideal tissue electroporation, as disclosed by Sherman, [0025].
Regarding claim 2, Eyster teaches the catheter of claim 1, the tip electrode further comprising irrigation ports (catheter 102 includes a lumen for irrigation, optionally embedded in the electrode 122, [0366]), and the tip electrode further comprising thermocouples therein (wherein the catheter 102 includes a thermocouple optionally embedded in the electrode 122, [0366]).
Regarding claim 3, Eyster teaches the catheter of claim 1, the tip electrode further comprising two electrode halves electrically insulated from each other, each half disposed over a respective portion of the distal end of the catheter, and at least one of the halves being configured to provide RF ablation electrical signals (see [0482] in which the catheter 102 is called out as having up to four individually actuatable electrodes 122 in which they can be used to individually deploy treatment energy at the tip and are shielded from each other, and therefore as there may be up to four electrodes 122 it also discloses on two electrodes shielded from each other configured to delivery treatment energy).
Regarding claim 4, Eyster teaches the catheter of claim 1, the tip electrode comprising a height measured along the longitudinal axis that measures about 3.5 millimeters (the electrode 122 has a length along the shaft of 3-4 mm, [0362]), and the proximal ring electrode and the middle ring electrode each comprising a respective height measured along the longitudinal axis that measures about 3 millimeters (as the ring electrodes maintain the same shape of the catheter as the delivery electrode does, the ring electrodes may also be 3-4mm in length, [0362]).
Regarding claim 5, Eyster teaches the catheter of claim 1, the middle ring electrode being disposed at an edge-to-edge distance of about 4 millimeters from the tip electrode and at an edge-to-edge distance of about 4 millimeters from the proximal ring electrode (wherein the diameter between the electrodes is disclosed as being any dimension between 1 to 10 mm and therefore Eyster discloses the 4-millimeter distance, [0362]).
Regarding claim 6, Eyster teaches the catheter of claim 1, further comprising: a contact force sensor disposed in a proximal direction in relation to the tip electrode and being configured to sense a force applied to the tip electrode as well as a direction of the force in relation to the longitudinal axis (see [0364], in which the catheter has a real time tri-axial force sensor located on the distal end where the tip electrode is located which is capable of sensing the force magnitude and direction).
Regarding claim 7, Eyster teaches an ablation system console (generator system 108, fig 1) comprising: one or more output ports (cable outputs 130, fig 1) configured to provide ablation energy to first, second, and third catheter electrodes while the first, second and third catheter electrodes are linearly aligned on a longitudinal axis of a distal portion of a catheter (see [0362] in which the cable outputs 130 delivery energy to the electrodes on the distal end of catheter 102, wherein the electrodes are linearly aligned, see fig 2B for electrodes 122 and two electrodes 125 aligned linearly, wherein the catheter can be configured to apply radiofrequency ablation, [0098]); a processor (processor 154, [0368]); and non-transitory computer readable medium in communication with the processor and comprising instructions thereon (the data storage and retrieval unit 156 in communication with the processor 154, [0368]), that when executed by the processor, cause the console to: provide an RF ablation signal (see [0369] in which the generator system, which contains the processor and data storage unit, is operable to create RF energy delivery to the treatment effector) via the output port(s) to the first catheter electrode (see [0362] in which the cable outputs 130 delivery energy to the electrodes on the distal end of catheter 102).
Eyster does not explicitly teach providing a first IRE ablation signal via the output port(s) as a first burst of biphasic pulses between the second and third catheter electrodes; the first IRE ablation signal being provided such that the first catheter electrode is activated separately from the second and third catheter electrodes and provide a second IRE ablation signal via the output ports as a second burst of biphasic pulses between the first and third catheter electrodes.
However, the analogous IRE and ablation catheter taught by Sherman does teach providing a first IRE ablation signal via the output port(s) as a first burst of biphasic pulses between the second and third catheter electrodes; the first IRE ablation signal being provided such that the first catheter electrode is activated separately from the second and third catheter electrodes and provide a second IRE ablation signal via the output ports as a second burst of biphasic pulses between the first and third catheter electrodes (see from Sherman, [0027], in which it is disclosed that the output voltage from the generator 16 to the individual electrodes 26 may be individually actuated as well as all having variable phase adjustments so that the energy voltage delivered between the desired bipolar electrode configuration may fall anywhere between approximately 500 to approximately 2000V based on the desired pulse mode. Sherman then goes on to teach that based on the activation phase of each electrode 26, some electrodes may receive more energy delivery between each other, while others may receive less or no energy activation between each other resulting in different distinct biphasic pulses, as illustrated within fig 3A showing pulses between the distal or first and third electrodes and in fig 3B showing pulses between the proximal or second and third electrodes. Thereby teaching first and second biphasic pulsed signals as claimed).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the catheter system taught by Eyster with that of the multiple different biphasic pulse capabilities taught by the IRE catheter of Sherman, in order to achieve different treatment waveforms based on the need of the patient such as differing IRE and ablation waveforms, as disclosed by Sherman, [0027].
Regarding claim 8, Eyster teaches the ablation system console of claim 7, further comprising: a body patch port (see fig 1, in which cable output 130 is shown to connect to a return electrode patch 106), the non-transitory computer readable medium further comprising instructions thereon, that when executed by the processor (processor 154 in communication with the storage data unit 156, [0368]), cause the console to: provide another IRE ablation signal as a burst of biphasic pulses between a body patch via the body patch port and at least one of the second and third catheter electrodes via the output port(s) (see [0363] in which biphasic pulse cycles are applied to the treatment electrodes 122 which are connected via cable 130 and applied via the return electrode patch 106).
Regarding claim 11, Eyster teaches the ablation system console of claim 7, the non-transitory computer readable medium further comprising instructions thereon, that when executed by the processor (processor 154 in communication with the storage data unit 156, [0368]), cause the console to: provide the first burst of biphasic pulses and the RF ablation signal via the output port(s) (see [0363] in which biphasic pulse cycles and RF treatment energy are applied to the treatment electrodes 122 which are connected via cable 130 and applied via the return electrode patch 106) such that the first catheter electrode is configured as a tip electrode disposed over a tip of the catheter (see delivery electrode 122 disposed at the distal end of shaft 120, fig 2B) and the second and third catheter electrodes are each configured as respective ring electrodes circumscribing a body of the catheter in a proximal direction in relation to the tip electrode (see fig 2B for ring electrodes 125 which are disposed proximal the delivery electrode 122).
Regarding claim 12, Eyster teaches the ablation system console of claim 9, the non-transitory computer readable medium further comprising instructions thereon, that when executed by the processor (processor 154 in communication with the storage data unit 156, [0368]), cause the console to: provide the first burst of biphasic pulses and the RF ablation signal via the output port(s) such that the second catheter electrode is configured as a tip electrode disposed over a tip of the catheter (see delivery electrode 122 disposed at the distal end of shaft 120 configured to be the second catheter electrode, fig 2B) and the first and third catheter electrodes are each configured as respective ring electrodes circumscribing a body of the catheter in a proximal direction in relation to the tip electrode (see fig 2B for ring electrodes 125 which are disposed proximal the delivery electrode 122 and are configured to be the first and third catheter electrode connections).
Regarding claim 14, Eyster teaches the ablation system console of claim 7, the non-transitory computer readable medium further comprising instructions thereon, that when executed by the processor (processor 154 in communication with the storage data unit 156, [0368]), cause the console to: provide the first burst of biphasic pulses at an amplitude of about 900 V, and provide the second burst of biphasic pulses at an amplitude of about 1800 V (see Sherman [0025] in which the electrodes are activated in a bipolar mode and in which the tip electrode 26A and the proximal electrode 26C are configured to apply energy between each other in the same phase, which is delivered at about 1000 V but when applied at the same phase it can create a second burst which can reach up to twice the voltage of 2000 V, therefore encompassing the claimed limitations of approximately 900V and 1800V).
Regarding claim 16, Eyster teaches the ablation system console of claim 7, the non-transitory computer readable medium further comprising instructions thereon, that when executed by the processor (processor 154 in communication with the storage data unit 156, [0368]), cause the console to: provide the ablation energy via the output port(s) such that the first catheter electrode is configured as a tip electrode disposed over a tip of the catheter (see delivery electrode 122 disposed at the distal end of shaft 120, fig 2B) and the second and third catheter electrodes are each configured as respective ring electrodes circumscribing a body of the catheter in a proximal direction in relation to the tip electrode (see fig 2B for ring electrodes 125 which are disposed proximal the delivery electrode 122 and are configured to be the second and third catheter electrode connections).
Regarding claim 17, Eyster teaches the ablation system console of claim 7, the non-transitory computer readable medium further comprising instructions thereon, that when executed by the processor (processor 154 in communication with the storage data unit 156, [0368]), cause the console to: provide the RF ablation signal to a first half of the first catheter electrode, the first half being electrically isolated from a second half of the first catheter electrode, the first and second halves disposed over a respective portion of a distal end of the catheter (see [0482] in which the catheter 102 is called out as having up to four individually actuatable electrodes 122 in which they can be used to individually deploy treatment energy at the tip and are shielded from each other, and therefore as there may be up to four electrodes 122 it also discloses on two electrodes shielded from each other configured to delivery treatment energy. As they are individually deployable one of the electrodes or the first half may deploy the RF ablation energy).
Regarding claim 18, Eyster teaches the ablation system console of claim 7, the non-transitory computer readable medium further comprising instructions thereon, that when executed by the processor (processor 154 in communication with the storage data unit 156, [0368]), cause the console to: determine a force vector applied to the distal portion of the catheter based on a sensor signal received by the console from the catheter (see [0364], in which the catheter 102 has a real time tri-axial force sensor located on the distal end where the tip electrode is located which is capable of sensing the force magnitude and direction).
Regarding claim 19, Eyster teaches the ablation system console of claim 7, further comprising: an irrigation module configured to provide irrigation fluid to the first catheter electrode (catheter 102 includes a lumen for irrigation, optionally embedded in the electrode 122, in which delivery of irrigation fluid is provided [0366]).
Regarding claim 20, Eyster teaches the ablation system console of claim 7, the non-transitory computer readable medium further comprising instructions thereon, that when executed by the processor (processor 154 in communication with the storage data unit 156, [0368]), cause the console to: determine temperature of the first catheter electrode based at least in part on a thermal sensor signal received from the catheter (wherein the catheter 102 includes a thermocouple optionally embedded in the electrode 122 used for temperature sensing, [0366]).
Claim(s) 10, 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Eyster (US Patent No 20210393327) in view of Sherman (US Patent No 20140066913) further in view of Gilbert (US Patent No 20170333109).
Regarding claim 10, the combination teaches the ablation system console of claim 7, the non-transitory computer readable medium further comprising instructions thereon, that when executed by the processor (Eyster, processor 154 in communication with the storage data unit 156, [0368]),
Eyster does not teach wherein it causes the console to: provide the IRE ablation signal via the output port(s) as a burst of biphasic pulses between the second and third catheter electrodes, while simultaneously providing the RF ablation signal to the first catheter electrode via the output port(s) .
However, the analogous IRE electroporation system of Gilbert does teach the console to: provide the first burst of biphasic pulses between the second catheter electrode and the third catheter electrode via the output port(s) (Gilbert, wherein the system has active and return terminals 230 and 232 connected to the electrodes 26 and provide a biphasic IRE output to be produced between the two, [0031]) while simultaneously providing the RF ablation signal to the first catheter electrode via the output port(s) (Gilbert, wherein the RF current is supplied as a concurrent secondary energy wave form to the delivery electrode 26, [0029]).
Therefore, it would have been obvious for one skilled in the art prior to the effective filing date to combine the system console of Eyster with the specific IRE ablation capabilities of Gilbert in order to achieve more precise IRE ablation capabilities as well as allow the system to use IRE energy in conjunction with RF energy as disclosed by Gilbert, [0005].
Regarding claim 15, the combination teaches the ablation system console of claim 7, the non-transitory computer readable medium further comprising instructions thereon, that when executed by the processor (Eyster, processor 154 in communication with the storage data unit 156, [0368]), cause the console to: provide a first RF ablation signal to the second catheter electrode via the output port(s), provide a second RF ablation signal to the first catheter electrode via the output port(s) (Gilbert, the system provides multiple output ports that connects the DC power supply 227 to the delivery electrodes for RF delivery, [0036], and therefore with multiple RF ablation electrodes multiple signals will be occurring simultaneously), simultaneously provide the first IRE ablation signal and the first RF ablation signal via the output port(s), and simultaneously provide the second IRE ablation signal and the second RF ablation signal via the output port(s) (Gilbert, wherein the system has active and return terminals 230 and 232 connected to the electrodes 26 and provide a biphasic IRE output to be produced between the two, [0031], wherein the RF current is supplied as a concurrent secondary energy wave form to the delivery electrode 26, [0029]).
Response to Arguments
Applicant’s arguments, see Remarks, filed 07/21/2025, with respect to the rejection(s) of claim(s) 1 and 7 under Eyster have been fully considered and are persuasive. However, upon further search consideration necessitated by the amended claim language, a new ground(s) of rejection is made in view of Eyster in view of Sherman.
The examiner agrees with the applicants remarks that Eyster alone does not teach the specific limitation that the electrodes are configured to be bipolar and deliver certain biphasic pulses between a middle and proximal electrode as well as a middle and tip electrode at an amplitude of approximately 900V. However, upon further consideration, it has been found that the new prior art of record of Sherman does teach which the electrodes are activated in a bipolar mode and in which the tip electrode 26A and the proximal electrode 26C are configured to apply energy between each other in the same phase, which is delivered at up to 1000 V, therefore encompassing the claimed limitations of approximately 900V. Furthermore, as there are multiple ring electrodes, the catheter electrode structure of Sherman matches that and all the capabilities of the limitations of claim 1. Therefore, as the new analogous prior art of record of Sherman discloses all of the previous discrepancies of Eyster, the independent claim 1 remains rejected under the new prior art of record rejection set forth of Eyster in view of Sherman.
Furthermore, the examiner agrees with the applicant that Eyster alone does not teach the limitations of delivering a distinct first and second IRE waveform burst between the catheter electrodes as currently amended in claim 7. However, as the amendment has necessitated further search and consideration, it has been found that the new prior art of record of Sherman does disclose that the output voltage from the generator 16 to the individual electrodes 26 may be individually actuated as well as all having variable phase adjustments so that the energy voltage delivered between the desired bipolar electrode configuration may fall anywhere between approximately 500 to approximately 2000V based on the desired pulse mode. Sherman then goes on to teach that based on the activation phase of each electrode 26, some electrodes may receive more energy delivery between each other, while others may receive less or no energy activation between each other resulting in different distinct biphasic pulses, as illustrated within fig 3A showing pulses between the distal or first and third electrodes and in fig 3B showing pulses between the proximal or second and third electrodes. Thereby teaching first and second biphasic pulsed signals as claimed by the amended limitation of claim 7. Therefore, as the new prior art of record reasonably teaches and discloses the amended limitation, claim 7 remains rejected under the new prior art of record rejection of Eyster in view of Sherman.
As no further arguments and remarks were made for any other dependent claims, they all remain rejected in prosecution under the prior art of record rejection set forth in the present office action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE M BROWN whose telephone number is (703)756-4534. The examiner can normally be reached 8:00-5:00pm EST, Mon-Fri, alternating Fridays off.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/KYLE M. BROWN/Examiner, Art Unit 3794