DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 23, 2025 has been entered.
Response to Amendment
This Action is in response to the Amendment filed 12/23/2025.
In view of the Amendment, claim 1 is amended to recite that the electrode of the catheter is able to transmit pulsed electric field energy, and the generator via a processor and a stored algorithm causes the electrode to provide an electric signal of pulsed electric field energy.
Claim 1-20 are amended.
Claims 1-20 are pending.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive. Applicant’s response misinterprets the Office Action dated 09/23/2025, adds the above features to the claim and asserts that the application is allowable over the prior art of record. The Examiner disagrees as the prior art of record discloses/teaches the invention, as now claimed.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-16 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application No. 2011/0152855 to Mayse et al. (hereinafter referred to as “Mayse”) in view of US Patent Application No. 2018/0221078 to Howard et al. (hereinafter referred to as “Howard”).
Referring to claims 1 and 3, Mayse discloses a system for treating a body passageway of a patient (e.g., abstract: systems to treat, to ablate, damage, and otherwise affect lung tissue; and Figs. 3, 8 and 16-18), the system comprising: a catheter comprising at least one electrode disposed near its distal end, wherein the distal end of the catheter is configured to be positioned within the body passageway so that the at least one electrode is able to transmit energy to a wall of the lung passageway (e.g., Figs. 3-5 and 8: catheter system 204; electrode 214; and paragraphs [0018]: delivery device is a catheter with a collapsible energy emitter assembly against an airway wall; [0159]: Figs. 3 and 8 shows a delivery device in the form of a catheter system 204 that treats airways of the main bronchi as well as those distal of the main bronchi 21,22 using ablation assembly 208; and [0163]-[0166]: ablation element is an RF electrode 214, which is brought into contact with inner surface 102 of the airway); and a generator in electrical communication with the at least one electrode (e.g., paragraph [0184]: internal power supply 248 supplies energy to electrode 214 and can be an RF electrical generator; and Fig. 8, 248), wherein the generator includes a processor and a memory storing at least one energy delivery algorithm/program (e.g., paragraph [0182]-[0183]: control module 210 [of catheter system 204] includes a controller 244 with one or more processors and memory devices storing at least one energy delivery algorithm/program), the generator configured to, when the processor executes the at least one energy delivery algorithm, cause the at least one electrode provide an electric signal of the energy transmittable to the wall which selectively treats particular cells at least on a surface of the wall (e.g., paragraphs [0021]-[0022]: target regions/lesions can be shaped using differential temperature control where target regions can include diseased or abnormal tissues, cardiac tissue, muscle tissue; [0166]: RF electrode 214 contacts or is proximate to the inner surface 102, see Fig. 4, and outputs RF energy which travels through the tissue including the surface tissue where the tissue is heated/treated; and [0212]: a circumferential lesion can be formed around all or most of the circumference of the airway wall 100 by ablating tissue while slowly rotating the ablation assembly). Mayse differs from the claimed invention in that it does not expressly disclose that the electrode transmits pulsed electric field energy and the electrode provides an electric signal comprising biphasic pulses, wherein at least some of the biphasic pulses are separated by a dead time so as to reduce biphasic cancellation.
However, Howard teaches, in a related art: profile parameter selection algorithm for electroporation/delivering energy to produce lesions (e.g., title and abstract of Howard), that electroporation may be used to ablate areas/create lesions of tissues and/or organs in the body to treat conditions of the body (e.g., paragraph [0004]: where the lung is an organ in the body; [0006]-[0007]: The present application provides for a method of determining a pulsed field ablation (PFA) waveform parameter for creating a desired lesion characteristic where in PFA system, desired programs of the pulsed electric fields delivered to the tissue are entered into an electrosurgical generator; [0011]: the programs entered desired lesion characteristics including at least one of lesion depth, lesion surface area, lesion width, and lesion length; [0033]-[0035]: the system 10 includes a medical device 12 coupled directly to an energy supply, for example, a pulsed field ablation generator 14 including an energy control, delivering and monitoring system or indirectly through a catheter electrode distribution system 16, and the generator includes processing circuitry containing instructions or algorithms to provide for automated operation and performance of features, etc.; [0037]: parameter selection algorithm may be programmed to correlate a desired treatment outcome to energy settings in the generator including waveform parameters to create a lesion of a particular length, width, surface area, and/or depth), and that the delivered waveform parameters include the number of pulses, duration of each pulse, number of pulse trains, applied voltage, electrode polarity configuration, inter-pulse timing, and the timing of the cycle length (e.g., paragraph [0037] of Howard). Howard further teaches that exemplary waveforms of the delivered electrical signal may employ biphasic pulses with a “switch” time between each polarity of the biphasic pulse -interphase- and an interpulse delay (dead time) between biphasic pulses (see Fig. 3 where the interphase delay is shorter than the interpulse delay and paragraph [0037] of Howard). It is the Examiner’s position that the exemplary waveforms taught by Howard would necessarily reduce biphasic cancellation. One of ordinary skill in the art before the effective filing date of the claimed invention would have modified the RF energy system of Mayse to be a generator that causes the electrode of the catheter to provide an electric signal of the pulsed electric field energy in view of the teachings of Howard that such parameters are well-known in the pulsed high voltage energy medical treatment art to provide lesions and treatment to walls of a body, and because the combination would have yielded predictable results.
With respect to claim 2, Mayse in view of Howard teaches the system of claim 1, but does not expressly teach that the dead time (between biphasic pulses) is up to 100 milliseconds. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Mayse in view of Howard with a dead time up to 100 milliseconds, 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]. The examiner notes that the instant specification does not provide criticality of the claimed dead time range.
As to claims 4-6, Mayse in view of Howard teaches the system of claim 1, wherein the biphasic pulses each have a positive phase and a negative phase which are balanced; an area under a curve of the positive phase equals an area under a curve of the negative phase; and the biphasic pulses have identical duration and voltage (see top waveform of Fig. 3 and paragraphs [0037]-[0039] of Howard: pulse width is set at 1-6 µs and may be constant to minimize bubble formation). Thus, one of ordinary skill in the art would have recognized the benefits of an electrical signal with a waveform having biphasic pulses with an identical duration and voltage and thus, the area under the curve for each positive phase would equal the area under the curve for each negative phase in view of the teachings of Howard. Accordingly, one of ordinary skill in the art would have modified the system of Mayse in view of Howard to have a balanced negative phase and positive phase of the biphasic pulse in order to limit the amount of energy delivered, limit bubble production from the electrodes, limit time of delivery, limit embolic loads, reduce unintended muscle stimulation or a combination of the same as taught by Howard, and because the combination would have yielded a predictable result.
With respect to claims 7-8, Mayse in view of Howard teaches the system of claim 1, wherein at least two of the biphasic pulses have different voltages or different durations (see bottom waveform of Fig. 3 of Howard – first (positive pulse) has a different voltage/height and a different duration than that of the second (negative pulse); and paragraph [0039] of Howard: the voltage delivered is a parameter that is optimized based on the desired lesion). Accordingly, one of ordinary skill in the art would have modified the system of Mayse in view of Howard to generate an electrical waveform having biphasic pulses where the positive and negative pulses have a different voltage and/or different duration as taught by Howard, and because the combination would have yielded a predictable result of a system optimizes the parameters as taught by Howard to achieve the desired ablation.
As to claim 9, Mayse in view of Howard teaches the system of claim 1, wherein the particular cells comprise precancerous cells or cancerous cells (e.g., paragraphs [0015] of Mayse: treatment system treats a wide range of pulmonary symptoms, conditions, and/or diseases that lead to increased resistance to airflow in the lungs; and [0021]: diseased tissue such as cancerous or non-cancerous tumors are part of the target region; paragraph [0037] of Howard: cancerous tissue may be the target tissue where a lesion is desired).
With respect to 10, Mayse in view of Howard teaches the system of claim 9, wherein the electric signal comprises 100 packets of biphasic pulses (e.g., paragraphs [0010]-[0012] and [0037] of Howard: electrosurgical generator is configured to deliver electroporation pulses between adjacent electrodes where the electrical waveform includes number of pulses, duration of each pulse, number of pulse trains, an applied voltage, electrode polarity configuration and inter-pulse timing. The Examiner considers number of pulse trains as correlating to number of packets). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Mayse in view of Howard to have 100 packets of biphasic pulses, 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]. The examiner notes that the instant specification does not provide criticality for the number of packets being 100 (see paragraph [00316] of the instant specification which mentions the number of packets could be from 1-1000 packets).
As to claim 11, Mayse in view of Howard teaches the system of claim 1, further comprising a user interface configured to allow operator-defined inputs comprising duration of energy delivery or other timing aspects of the energy delivery pulse, power, target temperature, mode of operation, or a combination of these (e.g., paragraph [0037] of Howard: algorithm may be programmed to select energy parameters to create the desired lesion input by the user as well as these user inputs: type of catheter, inter-electrode arrangement and spacing, number of electrodes and shape of electrode arrangement, type of target tissue, and desired lesion characteristic, length, width, and depth – which the Examiner considers the “mode of operation”). One of ordinary skill in the art before the effective filing date of the claimed invention would have further modified the system of Mayse in view of Howard to include a user interface in order for the user to be able to input the desired lesion characteristics, length, width, depth, etc. in view of the teachings of Howard that such user inputs are well-known in the pulsed high voltage energy medical treatment art, and because the combination would have yielded predictable results.
With respect to claim 12, Mayse in view of Howard teaches the system of claim 11, wherein mode of operation comprises system initiation and self-test, operator input, algorithm selection, pre-treatment system status and feedback, energy delivery, post energy delivery display or feedback, treatment data review and/or download, software update, or a combination of these (e.g., paragraph [0037] of Howard: operator input and algorithm selection as discussed above w/r/t claim 11). One of ordinary skill in the art before the effective filing date of the claimed invention would have further modified the system of Mayse in view of Howard where the mode of operation would include a user being able to input the desired lesion characteristics, length, width, depth, etc. so that energy parameters can be selected by an algorithm in view of the teachings of Howard that such user inputs are well-known in the pulsed high voltage energy medical treatment art, and because the combination would have yielded predictable results.
With respect to claim 13, Mayse in view of Howard teaches the system of claim 1, wherein the signal comprises a frequency and a voltage (e.g., paragraphs [0184] and [0037] of Mayse: [0184] energy generator supplies RF energy at a desired frequency; [0037] energy is delivered from an electrode with a substantially uniform voltage implies that the energy signal has a voltage), and wherein an effect of the frequency inversely balances an effect of the voltage so as to target particular cells (e.g., paragraph [0015]: an energy emitter assembly can treat one or more target sites without treating non-targeted sites – thus the system of the combination is capable of targeting particular cells using frequency and voltage).
As to claim 14, Mayse in view of Howard teaches the system of claim 1, but does not expressly teach that each of the biphasic pulses has a voltage between approximately 500-4000 V. Mayse teaches that energy can be used to damage target regions and includes pulsed high voltage energy (e.g., paragraph [0171] of Mayse). Howard teaches an electrosurgical generator that delivers pulses between adjacent electrodes via a waveform with an applied voltage (e.g., paragraphs [0010], [0015]-[0016] of Howard) that can be high voltage energy (e.g., paragraph [0035] of Howard, and/or biphasic pulses (e.g., paragraphs [0037]-[0038] of Howard). It would have been further obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Mayse in view of Howard with a voltage between approximately 500-4000V, 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]. The examiner notes that the instant specification does not provide criticality of the claimed voltage range, and that US Patent Application Publication No. 2012/0220998 to Long is evidence that the claimed voltage range was known to those in the electrical ablation art.
With respect to claim 15, Mayse in view of Howard teaches the system of claim 1, wherein the electric signal has a frequency in the range of approximately 100-1000 kHz (e.g., paragraph [0184] of Mayse: RF frequency can be output from the generator at a desired frequency in a range of 50kHz to about 1,000 MHz). The claimed ranged of 100kHz to about 1000kHz is within the range disclosed by Mayse.
As to claim 16, Mayse in view of Howard teaches the system of claim 1, wherein the at least one energy delivery algorithm comprises a selectable first energy delivery algorithm that delivers energy to the at least one electrode so as to function in a monopolar fashion with a dispersive electrode and a selectable second energy delivery algorithm that delivers energy to at least two electrodes of the at least one electrode so that the at least two electrodes function in a bipolar fashion (e.g., paragraph [0036] of Howard: generator 14 may be operable in one or more modes of operation including a monopolar or unipolar delivery using one electrode, and a bipolar energy delivery between two electrodes; and [0037] of Howard: waveform parameter selection algorithm provides/outputs the waveform parameters that correlate to creating the desired lesion input by the user). Accordingly, one of ordinary skill in the art would have recognized the benefits of a generator being able to operate in a monopolar fashion, a bipolar fashion, or a combination of the two in view of the teachings of Howard. Consequently, one of ordinary skill in the art would have modified the system of Mayse in view of Howard further so that, depending on the inputted desired lesion and the number of electrodes input by the user, the parameter selection algorithm can choose between a selectable first energy algorithm to deliver energy in a monopolar fashion and a selectable second energy algorithm to deliver energy in a bipolar fashion as taught by Howard, and because the combination would have yielded a predictable result.
With respect to claim 19, Mayse in view of Howard teaches the system of claim 1, wherein the at least one energy delivery algorithm delivers energy to the at least one electrode in a multiplexed fashion (e.g., paragraph [0314] of Mayse: electrodes can be activated concurrently in a bipolar mode).
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Mayse in view of Howard as applied to claim 1 above, and further in view of US Patent Application Publication No. 2012/0220998 to Long et al. (hereinafter referred to as “Long”).
With respect to claim 17, Mayse in view of Howard teaches the system of claim 1, wherein the at least one energy delivery algorithm is capable of delivering energy to the at least one electrode so as to function in a monopolar fashion with a dispersive electrode and delivering energy to at least two electrodes of the at least one electrode so that the at least two electrodes function in a bipolar fashion, but does not expressly teach that the energy delivery algorithm switches between the two modes. However, Long teaches, in a related art: electrical ablation device, that an energy source 14 may be configured to produce RF waveforms at predetermined parameters for thermal heating and electrical ablation of cells in the tissue treatment region and that a commercial bipolar/monopolar electrosurgical RF generator was known in the art (e.g., paragraph [0061] of Long). That is, Long teaches that one of ordinary skill in the art could switch from delivering energy in a monopolar fashion to delivering energy in a biphasic fashion so that the undesirable tissue is heated in a monopolar fashion and then ablated by exposure to electrical potential across the electrodes in a biphasic manner (e.g., Figs. 9A-B and 10A-B and paragraphs [0077]-[0078] of Long: In one embodiment, the first sequence of electrical pulses may comprise biphasic pulses and the second sequence may not comprise biphasic pulses). Accordingly, one of ordinary skill in the art would have recognized the benefits of a generator being able to switch between operations in a monopolar fashion, a bipolar fashion in view of the teachings of Long. Consequently, one of ordinary skill in the art would have modified the system of Mayse in view of Howard further so that, depending on the inputted desired lesion and the number of electrodes input by the user, the parameter selection algorithm can switch between delivering energy in a monopolar fashion and delivering energy in a bipolar fashion as taught by Long, and because the combination would have yielded a predictable result.
As to claim 18, Mayse in view of Howard and Long teaches the system of claim 17, wherein switching is configured to achieve a desired treatment area and/or depth of treatment (e.g., paragraph [0037] of Howard: the algorithm correlates the desired lesion characteristics to outputted waveform parameters where the modeled lesion characteristics are a function of the delivered waveform parameters and user inputs).
Accordingly, one of ordinary skill in the art would have modified the system of Mayse in view of Howard and Long further so that, depending on the inputted desired lesion characteristics and the number of electrodes input by the user, the parameter selection algorithm can choose the mode of operation as taught by Howard, and because the combination would have yielded a predictable result.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Mayse in view of Howard as applied to claim 19 above, and further in view of US Patent Application Publication No. 2019/0030328 to Stewart et al. (EFD 07/28/2017; hereinafter referred to as “Stewart”).
As to claim 20, Mayse in view of Howard teaches the system of claim 19, but does not expressly teach that the multiplexed fashion comprises cycling delivery of energy through any pair of two electrodes of the at least one electrode wherein one of each pair of the two electrodes is neutral. However, Stewart, in a related field: system for electroporation, teaches that following a set of deliveries of energy between active electrodes, the roles of active and neutral electrodes may be reversed such that the active pairs become neutral and the formerly neutral electrodes become the active electrodes (e.g., paragraph [0056] of Stewart). That is, Stewart teaches that the cycling of energy through any pair of two electrodes where the two pairs could be active and neutral depending upon the set of energy delivery. In view of the teachings of Stewart, one of ordinary skill in the art would have recognized the benefits of cycling delivery through two electrodes where at least one electrode is neutral. Consequently, in order to alter the electric field vectoring between sets of energy deliveries, one of ordinary skill in the art would have modified the system of Mayse in view of Howard to have the feature of claim 20 as taught by Stewart, and because the combination would have yielded a predictable result.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-9, 20, 28, and 31 of U.S. Patent No. 11,471,208 in view of Howard.
Claims 1 and 3 of the instant application are conflicting or coextensive with claim 1 or 20 of the ‘208 patent, except for the type of energy transmitted by the electrode. However, Howard teaches using pulsed electrical field energy to treat a wall of a body passageway as discussed above with respect to the rejection of claims 1 and 3 of the instant application under 35 USC 103 above.
Claims 2 and 4-5 of the instant application is conflicting or coextensive with claim 1 or 20 of the ‘208 patent, as modified by Howard as above, and further modified as discussed in the 35 USC 103 rejection of claims 1 and 4-5 above.
Claim 6 of the instant application is conflicting or coextensive with claim 7 of the ‘208 patent, as modified by Howard.
Claim 7 of the instant application is conflicting or coextensive with claim 8 of the ‘208 patent, as modified by Howard.
Claim 8 of the instant application is conflicting or coextensive with claim 9 of the ‘208 patent, as modified by Howard.
Claims 10-12 of the instant application are conflicting or coextensive with claim 1 or 20 of the ‘208 patent, as modified by Howard as set forth in the 35 USC 103 rejection of claims 10-12 above.
Claim 13 of the instant application is conflicting or coextensive with claim 1 or 20 of the ‘208 patent, as modified by Howard.
Claims 14-15 of the instant application are conflicting or coextensive with claim 28 of the ‘208 patent, as modified by Howard.
Claim 16 of the instant application is conflicting or coextensive with claim 1 or 20 of the ‘208 patent, as modified by Howard as set forth in the 35 USC 103 rejection of claim 16 above.
Claims 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,471,208 in view of Howard and Long.
Claims 17-18 of the instant application are conflicting or coextensive with claim 1 or 20 of the ‘208 patent, as modified by Howard and Long as set forth in the 35 USC 103 rejection of claims 17-18 above.
Claim 19 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 or 20 of U.S. Patent No. 11,471,208 in view of Howard and Mayse.
Claim 19 of the instant application is conflicting or coextensive with claim 1 or 20 of the ‘208 patent, as modified by Howard and Mayse as discussed above with respect to the 35 USC 103 rejection of claim 19.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 or 20 of U.S. Patent No. 11,471,208 in view of Howard, Mayse, and Stewart.
Claim 20 of the instant application is conflicting or coextensive with claim 1 or 20 of the ‘208 patent, as modified by Howard and Mayse as discussed above and further including the modifications of Stewart with respect to the 35 USC 103 rejection of claim 20.
Conclusion
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/CATHERINE M VOORHEES/ Primary Examiner, Art Unit 3792