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 January 21, 2026, have been fully considered by the examiner. The following is a complete response to the January 21, 2026 communication.
Information Disclosure Statement
The numerous references cited in the Information Disclosure Statements of January 22, 2026 have been afforded a cursory review, similar to what would be expected of a classification search of the prior art.
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 21-24, 27-32, 43 and 44 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Davalos et al (2010/0331758).
Regarding claim 21, Davalos et al disclose a method comprising providing a plurality of treatment pulses to tissue via an electrode to induce IRE (Abstract), measuring a current value associated with the plurality of treatment pulses and determining if the measured current is within an acceptable range (para. [0133-0134], for example). If the current value is within an acceptable range, the treatment pulses are continued, and if the measured current value is outside the acceptable range, the IRE pulse parameters are adjusted (para. [0133-0134]).
Regarding claims 22-24, pulse parameters are adjusted based on measured impedance as a feedback (para.[0133]). Regarding claim 27, the sensing pulses may be delivered before, during and after treatment pulses (para. [0133-0134]). Regarding claim 28, the test pulses having a lower voltage and may be applied between treatment pulses (para. [0134], for example). Regarding claim 29, again both pre-treatment test signals and intra-treatment test signals are used and compared to control pulse parameters (para. [0133-0134]). Regarding claim 30, an algorithm is used to evaluate the measured current value (para. [0145]). Regarding claims 31-32, the measured current may be used to determine the success (i.e. completeness) of the procedure (para. [0133]). The percentage of completeness is inherently derived from the values obtained as the measured current progresses to the threshold. Regarding claim 43, again, the percentage of completeness is inherently derived from the values obtained as the measured current progresses to the threshold. Regarding claim 44, Davalos et al disclose adjusting parameters (e.g. pulse length, voltage, current) based on sensed feedback (para. [0133-0134]).
Allowable Subject Matter
Claims 41 and 42 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 33, 34, 36-38 and 45 are allowed. The prior art fails to disclose the method comprising using the specific algorithm and comparison required by these claims.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at (571) 272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/March 24, 2026
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