Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s amendments and comments, received October 23, 2025, have been fully considered by the examiner. The following is a complete response to the October 23, 2025 communication.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 30, 34-40 and 42-48 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Pearson et al (2010/0250209).
Regarding claim 30, Pearson et al provide a method of treating a lesion (para. [0040], for example) comprising the steps of activating a generator to administer at least one test pulse and then activating the generator to administer an electrical energy based treatment via electrodes based on a measured response of the test pulse. See, for example, paragraphs [0202-0203]. The generator is coupled to a processor (54) and a display device (Figure 10, for example). The processor/controller monitors a parameter (e.g. current or voltage) associated with the electrical energy treatment to monitor a progress of the electrical energy based treatment, and displays a progress of the treatment in real time as well as the result of the energy based treatment. See, for example, paragraphs [0208-0217].
Regarding claim 34, Pearson et al specifically mention the measurement of current from the test pulse (para. [0203]). Regarding claim 35, Pearson et al teach it is known to determine a baseline electrical conductivity of the patient/tissue using the measured current (para. [0091], for example).
Regarding claim 36, Pearson et al again disclose a method of treating a lesion comprising applying a test pulse via an electrode (para. [0202-0203]) and optimizing a treatment plan based on the measured response to the test pulse. A treatment pulse plan is then applied to tissue, and the system monitors a parameter (e.g. current) to monitor a progress of the treatment and to determine a result of the treatment. The results include the progress of the ablation and the determination that a lesion was successful. Again, see paragraph [0208-0217] which discusses determining the progress of the ablation and the determination of success as well as the display of this data.
Regarding claim 37, Pearson et al teach it is known to generate an estimated treatment volume for the treatment plan (para. [0088], for example). Regarding claim 38, see claim 34. Regarding claim 39, see claim 35. Regarding claim 40, Pearson et al also disclose monitoring impedance (para. [0091], for example). Regarding claims 42-44, Pearson et al disclose the steps of monitoring voltage and a current of the treatment energy (para. [0210], for example) as well as monitoring high/low voltage and/or current conditions. Regarding claim 45, see paragraph [0216] which addresses a successful treatment. Regarding claims 46-48, see again paragraph [0210].
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 31-33 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pearson et al (‘209) in view of the teaching of Wham et al (6,976,981).
While Pearson et al disclose the use of a test pulse to determine baseline parameters for the treatment energy, there is no express disclosure of administering an additional test pulse after the treatment pulses have been initiated.
As addressed in the previous Office action, Wham et al disclose another system that treats energy with pulses of RF energy, and specifically teach that a test pulse may be employed from which impedance measurements are made to determine the parameters of the treatment pulses. Wham et al also disclose providing the test pulses at various intervals during the treatment and adjusting successive pulses based on the sensed impedance.
To have provided the Pearson et al system with an algorithm of applying subsequent test pulses after treatment energy has begun to modify the treatment pulses going forward in the procedure would have been an obvious consideration for one of ordinary skill in the art since Wham et al fairly teach the use of subsequent test pulses when controlling the treatment energy level applied to treat tissue.
Regrading claims 32 and 33, both Pearson et al and Wham et al disclose measuring a response of a low-level (e.g. non-electroporating) test pulse including measuring electrical conductivity.
Claim 41 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Pearson et al (‘209) in view of the teaching of Neal, II et al (2013/0184702).
Neal, II et al disclose a system substantially analogous to the Pearson et al system, and Neal, II et al specifically teach that the test pulse may be an AC signal, and the treatment pulses are a DC signal. See paragraph [0154] which discusses the use of an AC test pulse, and paragraph [0110] which discusses the use of DC treatment pulses.
To have provided the Pearson et al system with an AC test pulse to determine treatment parameters for the DC pulses used to treat tissue would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Neal, II et al fairly teach it is known to use AC test pulses to determine parameters for subsequent DC treatment pulses in an analogous IRE treatment system.
Response to Arguments
Applicant’s arguments with respect to the 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.
Conclusion
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 MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/December 8, 2025