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 .
Applicant’s amendments and comments, received with the response filed September 9, 2026, have been fully considered by the examiner. The acceptable Terminal Disclaimer has obviated the double patenting issues. The following is a complete response to the September 9, 2026 communication.
Information Disclosure Statement
The numerous references cited in the multiple Information Disclosure Statements have been afforded a cursory review, similar to what would be expected of a classification search of the prior art. Should there be any references of particular relevance to the instant application claims, applicant is respectfully requested to identify such references for further examiner review.
Claim Rejections - 35 USC § 103
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.
1-7, 9-17, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Callas et al (‘368) in view of the teaching of Viswanathan (2019/0336207).
Regarding claim 1, Callas et al disclose a method of treating tissue comprising disposing a plurality of electrodes in target tissue (Figures 4 and 9, for example) and activating the generator to deliver electrical pulses to the target region. Trains of pulses are delivered between pairs of electrodes in a cyclic manner (col. 15, lines 5-45, for example), wherein a single cycle includes a train of pulses delivered between each pair of electrodes in a consecutive order and repeating the cycles until a desired number of pulses is achieved. In the cited example at column 15, lines 10-20, the cycle of three electrodes is (1-2, 2-3, 3-1, 2-1, 3-2 and 1-3). There is no express disclosure of a cycle of electrodes whereby activation of at least one consecutive pair of electrodes involves no consecutive electrode activation. It is noted that Callas et al disclose embodiments having more than three electrodes, but there is no express disclosure of examples of cycling for those embodiments.
Viswanathan disclose a similar system for treating tissue whereby pulses are delivered to electrode pairs to treat tissue. Viswanathan et al disclose multiple electrode pairs (Figure 6) that are cyclically activated with pulse trains to treat tissue. In particular, Viswanathan specifically teach that the pairs of electrodes are activated such that consecutive activated pairs do not involve a consecutive electrode activation. See, for example, paragraph [0086].
To have provided the Callas et al system with an activation cycle that did not repeat an electrode in the consecutive activation of electrode pairs to treat tissue would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Viswanathan teach a similar system for activating electrode pairs with no consecutive activation of an electrode in consecutive activations of electrode pairs.
Regarding claim 2, see Callas et al at column 15, lines 10-15 which shows an example fitting the claim limitation with 10 pulses being delivered to each pair for a number of sequences that would fall within the 70-90 total pulses. Callas et al also disclose a delay between cycles as claimed (col. 15, lines 40-44). Regarding claim 3, Callas et al disclose the treatment of prostate tissue (col. 8, line 27) as well as pancreatic tissue (col. 7, line 17). Regarding claim 4, see column 15, lines 34-38 of Callas et al. Regarding claim 5, see again column 15, lines 40-44 of Callas et al. Regarding claim 6, each pulse of Callas et al may comprise a burst of pulses. Regarding claim 7, the intent of the Callas et al method is to mitigate thermal damage (e.g. Claim 1, for example). Regarding claim 9, as Callas et al seek to avoid thermal damage, the ideal operation would be a 0% amount of thermally damaged tissue (which is less than 5%). Regarding claim 10, the cycles described at the above noted column 15 of Callas et al meet this limitation, particularly when combined with the Viswanathan teaching as addressed above. Regarding claim 15, Callas et al expressly disclose causing electroporation and irreversible electroporation throughout the specification.
Regarding claim 12, Callas et al disclose a method comprising delivering a first subset of pulses to a first pair of electrodes, and delivering a second subset of pulses via a second pair of electrodes wherein the number of pulses to each pair is less than the total number of pulses (i.e. the treatment is repeated). See, again, column 15, lines 5-40. The example cited at column 15 includes the delivery of 70 to 90 pulses (i.e. 20-440 pulses depending on the number of times the cycle is repeated) with 10 pulses being applied for each subset. Callas et al fail to provide a specific example whereby the activation of consecutive pairs of electrodes involves no consecutive electrode activation.
As addressed above, Viswanathan disclose a similar system for treating tissue whereby pulses are delivered to electrode pairs to treat tissue. Viswanathan et al disclose multiple electrode pairs (Figure 6) that are cyclically activated with pulse trains to treat tissue. In particular, Viswanathan specifically teach that the pairs of electrodes are activated such that consecutive activated pairs do not involve a consecutive electrode activation. See, for example, paragraph [0086].
To have provided the Callas et al system with an activation cycle that did not repeat an electrode in the consecutive activation of electrode pairs to treat tissue would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Viswanathan teach a similar system for activating electrode pairs with no consecutive activation of an electrode in consecutive activations of electrode pairs.
Regarding claims 13-17, see above discussion regarding claims 3-7 above. Regarding claim 19, see discussion of claim 11 above.
Regarding claim 20, Callas et al disclose a method of irreversibly electroporating tissue (col. 2, lines 60-67, for example) comprising electrically coupling a plurality of electrodes to a generator and disposing the electrodes near target tissue (Figures 1, 4 and 6, for example) and activating the generator to deliver electrical pulses to the target tissue. The pulses are delivered in a cycled pulse sequence with the total number of pulses being delivered between subsets of electrical pulses, with the plurality of electrodes activated in a sequential order to deliver pulses to define a pulses cycle that may be repeated until a desired number of pulses are delivered. See, for example, the column 15 citation mentioned previously. Again, Callas et al fail to disclose the activation of consecutive electrode pairs involves no consecutive electrode activation.
Viswanathan disclose a similar system for treating tissue whereby pulses are delivered to electrode pairs to treat tissue. Viswanathan et al disclose multiple electrode pairs (Figure 6) that are cyclically activated with pulse trains to treat tissue. In particular, Viswanathan specifically teach that the pairs of electrodes are activated such that consecutive activated pairs do not involve a consecutive electrode activation. See, for example, paragraph [0086].
To have provided the Callas et al system with an activation cycle that did not repeat an electrode in the consecutive activation of electrode pairs to treat tissue would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Viswanathan teach a similar system for activating electrode pairs with no consecutive activation of an electrode in consecutive activations of electrode pairs.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Callas et al (‘368) in view of Viswanathan (‘207) and further in view of the teaching of Mercader et al (9,014,789).
The Callas et al method, as modified by the teaching of Viswanathan, has been addressed previously. Callas et al fail to expressly acknowledge that thermal damaged is evidenced by white tissue coagulation. The examiner maintains that it is generally known that “white tissue” (as opposed to red tissue) generally corresponds to thermally coagulated tissue. To that end, Mercader et al provide the general knowledge that “white tissue” refers to necrotic tissue after treatment to ablate tissue (see brief description of Figure 4D).
To have identified thermal effects during the Callas et al procedure, as modified by the teaching of Viswanathan, by identifying “white tissue” as evidence of thermally coagulated tissue would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Mercader et al provide the general teaching that it is known “white tissue” would evidence thermally necrotic tissue.
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely the same combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The examiner has now provided the Viswanathan reference to specifically teach the activation of consecutive electrode pairs with no consecutive electrode activation.
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/October 12, 2026
