DETAILED ACTION
The following is a Final Office Action on the merits.
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 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.
Response to Amendment
Acknowledgment is made to the amendment received 3/6/2026.
Applicant’s amendments are sufficient to overcome claim objections set forth in the previous office action.
Applicant’s amendments are not sufficient to overcome the 35 USC 112(a)/first paragraph rejection set forth in the previous office action.
Applicant’s amendments are sufficient to overcome the 35 USC 112(b)/second paragraph rejection set forth in the previous office action.
Claim Objections
Claims 1-3, 7-9, 22 & 26-28 are objected to because of the following informalities: amend “signals of the second type” to -signal of the second type- since only one rf signal is claimed for the signal of the second type. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: amend “amplitude of the each bipolar pulse” to -amplitude of each of the bipolar pulses- in ll. 2-3. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: amend “each electrode of the array of electrodes measured by the corresponding temperature sensor” to -each of the electrodes- in ll. 4. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: amend “comprises of electrodes” to -comprises electrodes- in ll. 4. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: amend “and and” to -and- in ll. 15-16. Appropriate correction is required.
Claim 22 is objected to because of the following informalities: delete “, the second sequence” in ll. 18. Appropriate correction is required.
Claim 25 is objected to because of the following informalities: amend “applying the signals of the first and second types” to -applying the signals of the first type- in ll. 1-2 since only the bipolar pulses are recited in the claim. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: amend “the first and second sequences of bipolar pulses, wherein each of the first and second sequences” to -the first sequence of bipolar pulses, wherein the first sequence- in ll. 2-3. Appropriate correction is required.
Claim 27 is objected to because of the following informalities: amend “the first and second sequences of bipolar pulses” to -the first sequence of bipolar pulses- in ll. 5. Appropriate correction is required.
Claim 30 is objected to because of the following informalities: amend “the temperature measured by the temperature sensors” to -a temperature of tissue adjacent to each of the electrodes measured by the plurality of plurality of temperature sensors. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4-8, 10-14, 22-28 & 32-33 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1 & 22 recite the limitation "the probe having only a proximal first electrode, a distal second electrode and an intermediary third electrode between and directly adjacent to the proximal first and distal second electrodes”. While the originally filed disclosure provides support for a “multi-electrode” catheter, the originally filed disclosure fails to provide support for a “multi-electrode” catheter having “only” three electrodes, thus excluding a two electrode catheter or a four or more electrode catheter. See MPEP 2173.05(i).
Claims 4-8, 10-14, 23-28 & 32-33 depend from claims 1 & 22 and are thus also rejected.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-8, 10-14, 22-28 & 32-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 & 22 recite the limitations “a probe…comprising electrodes disposed successively along the length of the probe…the probe having only a proximal first electrode, a distal second electrode and an intermediary third electrode between and directly adjacent to the proximal first and distal second electrodes” or “a probe…comprises electrodes disposed successively along the length of the probe…the probe having only a proximal first electrode, a distal second electrode and an intermediary third electrode between and directly adjacent to the proximal first and distal second electrodes”. It is unclear from the phrasing exactly how many electrodes are being claimed and if the first, second and third electrodes are a part of the “electrodes” or separate from the “electrodes”. For purposes of examination, the claims will be interpreted as -the electrodes having only a proximal first electrode, a distal second electrode and an intermediary third electrode between and directly adjacent to the proximal first and distal second electrodes-.
Claim 1 recites the limitation “the sequence of bipolar pulses being applied only to the proximal first electrode and the intermediary third electrode during a first period of time, and the radio-frequency (RF) signal being applied only to the intermediary third electrode and the distal second electrode during a first period of time”. There is no support in the original disclosure for the signals of the bipolar pulses and the RF signal to be applied during the same period time. For purposes of examination, the latter recitation of “first period of time” will be interpreted as -a second period time- as described in Figs. 4A-B and also claimed in claim 22.
Claims 1 & 22 recite the limitations “the sequence of bipolar pulses being applied only to the proximal first electrode and the intermediary third electrode during a first period of time, and the radio-frequency (RF) signal being applied only to the intermediary third electrode and the distal second electrode during a second period of time”. The originally filed disclosure fails to provide support for specifically applying the first signal type (IRE signal) to the proximal first and intermediary third electrode and then applying the second signal type (RF signal) to the intermediary third and distal second electrode. The originally filed disclosure provides support for the following: (1) applying a RF signal (308) between a positive and negative bipolar IRE pulses (310) (Fig. 4A) and for applying a RF signal (316) between a positive IRE pulse (318) and a negative IRE pulse (320) (Fig. 4B) ([0060-0063]); (2) for the RF and IRE signals to be applied between two adjacent/neighboring electrodes; (3) applying IRE signals to electrode pairs in adjacent fashion (1-2, 2-3) or interleaved fashion (not supported by a three electrode catheter) ([0031]); and (4) rapid switching between these two modalities, while coupling both the IRE and the RF ablation signals to the same electrodes, is accomplished by alternatingly closing and opening a bypass switch in parallel with the low-pass filter ([0037]). The originally filed disclosure fails to provide support for applying the IRE signal pulse(s) to the proximal first and intermediary third and then the RF signal to the intermediary third and distal second. From the disclosure, the possibilities with “only” three electrodes (E1=proximal first, E2=distal second, E3=intermediary third) claimed are as follows:
Time Period Electrodes Activated Signal Type
T1 E1-E3 IRE
T2 E1-E3 RF
T3 E-2-E3 IRE
T4 E3-E2 RF
or,
Time Period Electrodes Activated Signal Type
T1 E1-E3 IRE
T2 E2-E3 RF
Thus, the originally filed disclosure fails to specifically teach possession of the claimed second option at the time the invention was effectively filed where the electrode pair comprises different electrodes receiving the IRE and RF signals.
Claims 4-8, 10-14, 23-28 & 32-33 depend from claims 1 & 22 and are thus also rejected.
Response to Arguments
Applicant's arguments filed 3/6/2026 regarding the 35 USC 112(a)/first paragraph rejection have been fully considered but they are not persuasive.
In response to Applicant’s arguments the specification provides support for a “multi-electrode catheter” having successive pairs, or a range of electrodes of at least three electrodes (which then provides for at least two pair combinations between the three electrodes), and thus provides support for only a specific number of electrodes, for example three as claimed, the Examiner respectfully disagrees. The phrase “only” is not a range as argued, but rather, a negative limitation since it excludes any catheter having two or four or more electrodes. Further, the Examiner notes with respect to the cited In re Wertheim and Rai cases, the facts of the case differ from claims presented in the application. While MPEP 2173.05(i) states that “[t]he mere absence of a positive recitation is not basis for an exclusion”, the originally filed disclosure fails to reasonably convey to those skilled in the art possession of the claim subject matter of “only” three electrodes, and thus also possession of catheters having “only” four electrodes, “only” five electrodes, and etc.
Claims 1 & 22 recite the limitation "the probe having only a proximal first electrode, a distal second electrode and an intermediary third electrode between and directly adjacent to the proximal first and distal second electrodes”. While the originally filed disclosure provides support for a “multi-electrode” catheter, the originally filed disclosure fails to provide support for a “multi-electrode” catheter having “only” three electrodes, thus excluding a two electrode catheter or a four or more electrode catheter. See MPEP 2173.05(i).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Sherman (2014/0066913, previously cited) teaches applying both IRE and RF signals to electrode pairs, but fails to specifically disclose an electrosurgical generator configured to apply/applying the IRE signal to a proximal first and adjacent intermediary third electrode and then applying a RF signal to the adjacent intermediary third electrode and a distal second electrode.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794