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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 27, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement filed December 9, 2025 has been entered and the references cited therein have been considered by the examiner.
Previously Set Forth Rejections
All of the rejections set forth in the final Office action (mailed October 10, 2025) are hereby withdrawn.
The following new grounds of rejection are set forth:
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 9-11 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cosman, Jr. et al. (U.S. Patent Application Publication No. 2020/0330153 – hereinafter Cosman 2020) in view of Cosman, Jr. et al. (U.S. Patent Application Publication No. 2017/0049513 – hereinafter Cosman 2017).
In regard to claims 1, 2, 9 and 10 Cosman 2020 teaches an apparatus for NF ablation of tissue within a patient comprised of a generator 800 having a controller 840 and a power supply 850 where the power supply 850 includes an RF source (RF) and a nerve-stimulation source (Stim) (see Fig. 8). The RF source can generate a sinusoidal voltage across its + and – poles, with frequency in the radiofrequency range (see para. 0199). Stimulation source is configured to generate a nerve stimulation signal across its + and – poles, such as a waveform including biphasic square pulses (see para. 0199). The stimulation source can produce stimulation signal with biphasic pulses in the range 1 kHz – 50 kHz (see para. 0199). Thus, RF source and stimulation source constitute first and second voltage sources. Cosman 2020 teaches a plurality of electrodes 861, 862, 863, 864, 865, 866 and ground pads 835, 836 (see Fig. 8 and para. 0198). Switching unit 860 can connect and disconnect each of the electrodes to the RF output pole, the stimulation output pole and the reference output pole (see Fig. 8 and para. 0200). Figure 8 shows that for each electrode, there are three switches, each couplable to one of RF connection, stimulation connection and reference output connection. Cosman 2020 teaches that the HF generator 100 (equivalent to generator 800) can be an irreversible electroporation (IRE) ablation apparatus (see paras. 0090-0091). In such as situation, generator 800 would inherently be capable of containing a first voltage source for generating pulses for electroporation procedures and a second voltage source for generating pulses for electroporation procedures. Cosman 2020 is silent as to a plurality of isolation switches, each coupled between one of the three switches and the associated electrode. However, Cosman 2020 does teach that the switches in unit 860 can be mechanical switches (see Fig. 8 and para. 0200). Cosman 2017 teaches a similar RF generator 2011 that can be connected to multiple electrodes E1, E2, E3 (see Fig. 28) with switches S1, S2, S3 for controlling the power to the respective electrodes (see para. 0159). Switches S1, S2, S3 act as isolation switches to control the power to each electrode. Cosman 2017 thus demonstrates that the use of isolation switches to control the power to individual electrodes was well known in the art in order to control the sequence and timing of treatment by the multiple electrodes. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Cosman 2020 with the isolation switches taught by Cosman 2017, where the isolation switches are coupled between the one of the first, second and third switches and the associated electrode in order to control the sequence and timing of treatment by the multiple electrodes. Furthermore, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to made these isolation switches electro-mechanical switches, as Cosman 2020 teaches that the switches in unit 860 can be mechanical switches (see Fig. 8 and para. 0200). With further respect to claim 9, Cosman et al. teach ablation probe 150 that constitutes a catheter (see Fig. 1). In regard to claims 3 and 11, any combination of switches within switching unit 860 can constitute a “module” (see also para. 0201 noting that the controller 840 can operate the switches in unit 860 to produce a sequence of switching states, among other capabilities). In regard to claims 17-19, see the above rejection for claims 1-3 and 9-11. With further respect to claims 17, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the catheter and electrodes of Cosman 2020 and couple the electrodes to the generator 800 (with its components including the controller 840, the power supply 850 and the switching unit 860.
Claim(s) 4, 5, 12, 13, 20 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cosman, Jr. et al. (U.S. Patent Application Publication No. 2020/0330153 – hereinafter Cosman 2020) in view of Cosman, Jr. et al. (U.S. Patent Application Publication No. 2017/0049513 – hereinafter Cosman 2017) and further in view of Neal et al. (U.S. Patent Application Publication No. 2018/0071014).
In regard to claims 4, 5, 12, 13, 20 and 21, Cosman 2020 is silent as to current limiting resistors coupled between the voltage source and the switch. Neal et al. teach a similar electroporation system 1 comprised of a probe 2 and a power distribution unit 14 with multiple switches to control the signal (see Fig. 14). Neal et al. disclose that when the switch is in a second position, the system moves through a high impedance resistor to drop the voltage and prevent damage to tissue (see para. 0114). Neal et al. thus demonstrate that the use of resistors on switches to decrease voltage and prevent damage to tissue are well known in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention to provide the device of Cosman 2020 with the impedance resistors, in the manner disclosed by Neal et al., for the purpose of lowering the voltage and preventing damage to tissue.
Claim(s) 6, 7 and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cosman, Jr. et al. (U.S. Patent Application Publication No. 2020/0330153 – hereinafter Cosman 2020) in view of Cosman, Jr. et al. (U.S. Patent Application Publication No. 2017/0049513 – hereinafter Cosman 2017) and further in view of Forsyth et al. (U.S. Patent Application Publication No. 2020/0289185).
In regard to claims 6, 7 and 14-16, Cosman 2020 is silent as to the type of switches used in the device. However, Forsyth et al. teach a similar ablation device with switch arrays 620 where the switches may be relays, high power mosfets, silicon controlled rectifiers, other transistors, or multi-part switches (see para. 0119). Forsyth et al. thus demonstrate that the art is well aware of the use of multiple types of switches in ablation devices. Accordingly, it would have been an obvious matter of design choice, for one of ordinary skill in the art at the effective filing date of the invention, to make the switches of Cosman 2020 different types of transistors.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7 and 9-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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