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 .
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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03 February 2026 has been entered.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3-4, 10-11, 13-14 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Vrba et al. (US 2020/0197088) in view of Jameson et al. (US 2016/0199116).
Regarding claim 1, Vrba discloses a system for hepatic nerve denervation (see [0008] and [0156]), comprising: a medical device (see [0186]), including: an elongate body having a proximal portion and a distal portion opposite the proximal portion, the distal portion being configured to be in contact with an area of target tissue, the area of target tissue being an area of tissue within a hepatic artery (see [0186]); and a plurality of treatment electrodes coupled to the distal portion (see [0186]); and a generator in electrical communication with the medical device, the generator being configured to generate and deliver at least one pulse train of energy to the plurality of treatment electrodes to ablate the area of target tissue (see sequence of pulses, [0388]), wherein the plurality of treatment electrodes are arranged in a plurality of pairs (see four pairs of electrodes E1 and E2 wired together in Fig. 10C, [0253]). However, Vrba fails to explicitly teach electrode pairs as a plurality of pairs of adjacent electrodes with each pair of treatment electrodes having a polarity that is different than a polarity of an adjacent treatment electrode pair, and wherein each electrode of a respective treatment electrode pair has the same polarity during delivery of the at least one pulse train.
Jameson teaches a medical device comprising a plurality of electrode zones (see Figs. 1A-9) including a plurality of pairs of adjacent electrodes having a positive polarity (see top row of multiple adjacent positive pairs of electrodes, Figs. 3-8), each of which has an opposite polarity than that of the plurality of negative pairs of electrodes that are adjacent to the positive pairs (see bottom row of multiple adjacent negative pairs of electrodes, Figs. 3-8), wherein each electrode of the respective electrode pairs have the same polarity during delivery of energy (see positive and negative channels that connect the electrodes for energy delivery, therefore the polarity of the respective electrode pairs is the same during energy delivery, see at least [0009] and [0047]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the pairs of electrodes as disclosed by Vrba such that they comprised a plurality of pairs of adjacent electrodes with each pair of treatment electrodes having a polarity that is different than a polarity of an adjacent treatment electrode pair, and wherein each electrode of a respective treatment electrode pair has the same polarity during delivery of the at least one pulse train in light of Jameson, the motivation being to provide the advantage of being able to selectively activate and deactivate electrode pairs to treat specific segments of tissue while maintaining a high degree of control over which areas of tissue are being treated at any given time and avoiding current leakage or edge effects (see Jameson [0009] and [0035]).
Regarding claim 3, Vrba further discloses wherein the at least one pulse train of energy is delivered in one of a bipolar mode and a monopolar mode from the generator (see [0061]).
Regarding claim 4, Vrba further discloses at least one sensing electrode coupled to the distal portion of the elongate body (see [0435]), the at least one sensing electrode being configured to continuously measure and record a plurality of glucose measurements within the area of target tissue, the plurality of glucose measurements being indicative of a measured level of glucose uptake within the area of target tissue (see [0439]).
Regarding claim 10, Vrba further discloses wherein the medical device is further configured to determine whether denervation has occurred in the area of target tissue based on the measured level of glucose uptake within the area of target tissue (see [0439]).
Regarding claims 11, 13-14 and 19, Vrba in view of Jameson teaches the limitations of these claims under the same rationale as that applied in the rejections of claims 1, 3-4 and 10 above.
Claims 5-8, 15-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Vrba in view of Jameson and in further view of Toth et al. (US 2015/0173673).
Regarding claim 5, Vrba further discloses a control unit in communication with the medical device (see [0392] and [0462]), however Vrba in view of Jameson fails to specifically teach wherein at least one electrode pair of the plurality of treatment electrodes is configured to record at least one of an EMG signal and a compound action potential (CAP) signal and transmit the at least one of the EMG signal and CAP signal to the control unit.
Toth teaches a sympathetic nerve ablation system comprising electrodes (sensing tips that conduct current/accept current from local tissues, [0217]-[0218]) for monitoring evoked potentials and EMG signals to determine one or more reference signals, monitoring with one or more updated signals, and comparing the reference signals to the updated signals to determine an extent of completion for the surgical procedure (see [0122] and [0316]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one electrode pair of the plurality of treatment electrodes of Vrba in view of Jameson to be configured to record at least one of an EMG signal and a compound action potential (CAP) signal and transmit the at least one of the EMG signal and CAP signal to the control unit in light of Toth, the motivation being to determine the extent of completion for the surgical procedure (see Toth [0316]).
Regarding claim 6, Vrba in view of Jameson and Toth further teaches including wherein the control unit includes processing circuitry (see Vrba: microprocessor, [0392] and [0462]), the processing circuitry being configured to: establish at least one of a reference electromyogram and baseline CAP recording of the area of target tissue prior to the delivery of the at least one pulse train of energy (see Toth: reference signals, [0316]); obtain at least one of an electromyogram and second CAP recording of the area of target tissue following the delivery of the at least one pulse train of energy (see Toth: updated signals, [0316]); at least one of: compare the obtained electromyogram to the reference electromyogram; and compare the second CAP recording to the baseline CAP recording (see Toth [0316]). Toth further teaches alerting a user to a change in a different physiological signal after a surgical procedure (see Toth [0124]), therefore it would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Vrba to also generate an alert based at least in part on the comparison after the procedure in light of Toth, the motivation being to notify the surgeon of a change in the physiological parameters so that the user can assess the functionality of the tissue in the vicinity of the treatment electrodes after treatment (see Toth [0124]).
Regarding claim 7, Vrba in view of Jameson and Toth further teaches wherein the processing circuitry is further configured to determine whether denervation has occurred in the area of target tissue based on the comparison of the obtained electromyogram and the reference electromyogram or the comparison of the second CAP recording to the baseline CAP recording (see comparison as suggested by Toth [0316]).
Regarding claim 8, Vrba in view of Jameson and Toth teaches the limitations of claim 7, and fails to specifically teach wherein the control unit is further configured to discontinue the delivery of the at least one pulse train of energy from the generator when it is determined that denervation has occurred in the area of target tissue.
However, Toth further teaches using the comparison of reference and updated signals to determine whether to continue with, stop, or alter the surgical procedure (see Toth [0327]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified the control unit of Vrba in view of Jameson and Toth to also discontinue the delivery of the at least one pulse train of energy from the generator when it is determined that denervation has occurred in the area of target tissue in further light of Toth, the motivation being to prevent over-treatment of a particular treatment area when ablation is completed.
Regarding claims 15-18 and 20, Vrba in view of Jameson and Toth teaches the limitations of these claims under the same rationale and citations as those set forth in the rejections of claims 1, 4 and 5-8 above.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Vrba in view of Jameson, Toth, and in further view of Callas et al. (US 2017/0265929).
Regarding claim 9, Vrba in view of Jameson and Toth teaches the limitations of claim 8, however fails to further teach wherein the at least one pulse train of energy is delivered in a biphasic mode from the plurality of treatment electrodes.
Callas teaches a system for applying ablative irreversible electroporation pulses to tissue (see Fig. 1) including wherein the IRE pulses can be unipolar pulses or alternating polarity pulses such as biphasic pulses or consecutive positive and negative pulses separated by a slight time delay (see [0122]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the at least one pulse train of energy as taught by Vrba in view of Jameson and Toth to be delivered in a biphasic mode from the plurality of treatment electrodes in light of Callas, since the results of such a combination of elements would have been combinable and predictable to one of ordinary skill in the art for the purpose of successfully ablating tissue via irreversible electroporation pulses.
Response to Arguments
Applicant’s arguments with respect to the rejected claims 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. In the instant case, the new grounds of rejection are based on an obviousness type rejection in light of Vrba and Jameson instead of the previous rejection that was based solely in view of Vrba.
Conclusion
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794