Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. 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.
DETAILED ACTION
Acknowledgement is made of applicant’s amendment which was received by the office on July 14, 2026. Claims 21-39 and 41 are currently pending and under examination.
Specification
In view of the response filed on 7/14/2026 amending the specification to clarify the language the objections made against the specification in the office action of 4/14/2026 have been withdrawn.
Claim Rejections - 35 USC § 112
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.
Claim 39 is 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. Claim 39 recites the limitation "the display unit" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, as best understood, claim 39 has been interpreted to include displaying the tissue characteristic measurement.
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 negatived by the manner in which the invention was made.
Claims 33-36 and 38-39 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2010/0250209 to Pearson et al. (Pearson – previously cited) in view of US 2012/0197243 to Sherman et al. (Sherman).
In reference to at least claim 33
Pearson discloses a system for delivery of electrical energy to a target tissue during a treatment procedure (e.g. system, Fig. 1) the system comprising: a generator coupled to a processor (e.g. generator 10, Fig. 1), wherein the generator is configured to operatively couple to at least two electrodes positioned near the target tissue (e.g. probes 22, “each probe 22 includes either a monopolar electrode or bipolar electrodes having two electrodes separated by an insulating sleeve.”, para. [0040]), and the processor is coupled to a memory (e.g. “includes memory storage 44”, para. [0044]); a treatment control module stored in the memory (e.g. “and a treatment control module stored in the memory”, abstract, “Any of the software program modules in the program storage 48 and data from the data storage 50 can be transferred to the memory 44 as needed and is executed by the CPU 46.”, para. [0044]) and, when executed by the processor, the treatment control module performs operations comprising: receiving identification of a target treatment zone (e.g. “The generator 10 is connected to a treatment control computer 40 having input devices such as keyboard 12 and a pointing device 14, and an output device such as a display device 11 for viewing an image of a target treatment area such as a lesion 300 surrounded by a safety margin 301”, para. [0040], [0050]); generating an estimated ablation zone based in-part on the identification of the target treatment zone (e.g. “The treatment control module 54 generates an estimated ablation region based on the probe placement on the grid. The user can verify that the image of the lesion is adequately covered by the ablation region that is estimated by the treatment control module 54.”, para. [0226]); activating the generator to deliver at least one test pulse between the at least two electrodes (e.g. “ Therefore, to obtain viable conductivity values prior to treatment, a low amplitude voltage pulse is used between the electrode conductors and the resultant impedance/conductance is measured as a way to determine pertinent tissue property data such as the predicted current.”, para. [0091]; “the treatment control module 54 asks the user to "Click `Deliver test pulse` to start" in window 420 in order to start the test signal (pulse) sequence.”, para. [0202]-[0203], [0205]); receiving a tissue characteristic measurement of the target tissue after the at least one test pulse is delivered (e.g. “ Therefore, to obtain viable conductivity values prior to treatment, a low amplitude voltage pulse is used between the electrode conductors and the resultant impedance/conductance is measured as a way to determine pertinent tissue property data such as the predicted current.”, para. [0091]); and activating the generator to deliver treatment pulses capable of irreversibly electroporating cells within the target tissue (e.g. “ therapeutic energy such as pulses capable of irreversibly electroporating the tissue cells.”, para. [0039], [0055], [0225]).
Pearson discloses that impedance can be used to determine pertinent tissue property data (e.g. “ Therefore, to obtain viable conductivity values prior to treatment, a low amplitude voltage pulse is used between the electrode conductors and the resultant impedance/conductance is measured as a way to determine pertinent tissue property data such as the predicted current.”, para. [0091]). However, Pearson does not explicitly disclose comparing the tissue characteristic measurement to a predefined parameter and using the comparison to activate the generator.
Sherman discloses a method of assessing tissue ablation which discloses defining an impedance threshold and comparing a measured impedance to the threshold to determine tissue contact (e.g. “the obtained measurements can thus be compared to predetermined thresholds or values to assess whether the medical device has light contact with the targeted tissue, strong contact, and/or is only in contact with blood flow or a fluid stream around the device”, para. [0047]) and to determine a continuity of the thermally treated or ablated lesion or tissue segment (e.g. “The comparison may include, for example, the difference between impedance phase measured at a higher frequency and the measured phase at a lower frequency range. The comparison of baseline to post-treatment measurements may include assessing a change in Cole-Cole parameters. The post-treatment measurements may be compared to pre-established thresholds or values to determine whether the bipolar impedance values indicate a continuity of the thermally treated or ablated lesion or tissue segment.”, para. [0052]).
It would have been obvious to one of ordinary skill in the art at the time the invention to modify the system of Pearson to include comparing the tissue characteristic measurement such as impedance to a predefined parameter and using the comparison to activate the generator, as taught by Sherman, to determine whether good tissue contact has been made and/or to assess whether the test pulse delivered indicates an effective depth for treatment (‘243, para. [0052]).
In reference to at least claim 34
Pearson modified by Sherman renders obvious a system according to claim 33. Pearson further discloses wherein the tissue characteristic measurement is an impedance measurement of the target tissue (e.g. “ Therefore, to obtain viable conductivity values prior to treatment, a low amplitude voltage pulse is used between the electrode conductors and the resultant impedance/conductance is measured as a way to determine pertinent tissue property data such as the predicted current.”, para. [0091]).
In reference to at least claim 35
Pearson modified by Sherman renders obvious a system according to claim 34. Pearson further discloses wherein the operations further comprise determining, based in-part on the measured impedance, whether to change a treatment parameter prior to delivery of the treatment pulses (e.g. “The value determined may then be implemented when assessing field strength and treatment protocol in real time. For example, the resulting impedance or predicted current can be used to set the default electric field density.”, therefore the value determined is used to determine current treatment parameters and delivery of treatment pulses, para. [0091]).
In reference to at least claim 36
Pearson modified by Sherman renders obvious a system according to claim 34. Pearson further discloses wherein the at least one test pulse is a pre- determined voltage (e.g. “a low amplitude voltage pulse is used between the electrode conductors and the resultant impedance/conductance is measured as a way to determine pertinent tissue property data such as the predicted current.”, para. [0091]) and the treatment pulses comprise a pulse width of up to 100 microseconds, a number of pulses between 10 pulses to 100 pulses, and a voltage of up to 3,000 volts, and an amperage of up to 50 amps (e.g. “ In the example, the maximum voltage that can be generated between probes is limited by the capabilities of the generator 10, which in the example is limited to a maximum of 3000 Volts.”, para. [0079], [0195], “ or too high (e.g., approximately 45 amps or more).”, therefore the amps are at least below 45 amps to ensure the current is not too high, para. [0203]-[0204]).
In reference to at least claim 38
Pearson modified by Sherman renders obvious a system according to claim 34. Pearson further discloses wherein the operations further comprise changing at least one treatment parameter after the delivery of the test pulse and before the delivery of the treatment pulses (e.g. “The value determined may then be implemented when assessing field strength and treatment protocol in real time. For example, the resulting impedance or predicted current can be used to set the default electric field density.”, therefore the value determined is used to determine current treatment parameters and delivery of treatment pulses in real time, para. [0091]).
In reference to at least claim 39
Pearson modified by Sherman renders obvious a system according to claim 33. Pearson further discloses wherein the operations further comprise displaying, during the delivery of the treatment pulses, the tissue characteristic measurement on the display unit, wherein the tissue characteristic measurement comprises at least one of an impedance measurement, a voltage measurement, a current measurement, or an electrocardiogram measurement (e.g. “one or more impedance sensors may be used to monitor the progress of the RF ablation treatment.”, para. [0066]).
Allowable Subject Matter
Claims 21-32 and 41 are allowed. Claim 37 is 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.
The following is a statement of reasons for the indication of allowable subject matter: In view of the art that is relevant to the claimed invention the prior art does not teach or reasonably suggest, within the context of the other claim elements, a processor that executes a treatment module that performs the operations of activating the generator to deliver the at least one test pulse between the at least two electrodes thereby altering an impedance of the target tissue in a pre- treatment zone defined between the at least two electrodes, receiving an impedance measurement of the target tissue after the at least one test pulse is delivered, determining whether the measured impedance satisfies a threshold impedance condition comprising a predefined impedance value; and upon determining that the measured impedance satisfies the threshold impedance condition, activating the generator to deliver treatment pulses capable of irreversibly electroporating cells within the target tissue, wherein the pre-treatment zone is smaller than a target ablation zone of the target tissue to be treated by the treatment pulses, respectively in combination with the other claim elements. The closest prior art includes US 2010/0250209 to Pearson et al. and US 2006/0024359 to Walker et al. (both previously cited) which teach therapeutic energy delivery devices for tissue destruction but do not teach or reasonably suggest the specific operations recited in the claims including altering an impedance of the target tissue in a pre- treatment zone defined between the at least two electrodes, receiving an impedance measurement of the target tissue after the at least one test pulse is delivered, determining whether the measured impedance satisfies a threshold impedance condition comprising a predefined impedance value; and upon determining that the measured impedance satisfies the threshold impedance condition, activating the generator to deliver treatment pulses capable of irreversibly electroporating cells within the target tissue, wherein the pre-treatment zone is smaller than a target ablation zone of the target tissue to be treated by the treatment pulses.
Response to Arguments
Claim Rejections under 35 USC 103
Applicant’s arguments, see pgs. 8-9, filed 7/14/2026, with respect to the 103 rejection(s) of claim(s) 21-32 using Pearson in view of Ostrovsky have been fully considered and are persuasive in view of the claim amendments now reciting specifics regarding an impedance within a pre-treatment zone, a threshold impedance and a size related to the pre-treatment zone. Therefore, the 103 rejection(s) of claim(s) 21-32 using Pearson in view of Ostrovsky has been withdrawn, see further details above within the allowable subject matter.
Applicant’s arguments, see pg. 9, filed 7/14/2026, with respect to the 103 rejection(s) of claim(s) 33-36 and 38-39 using Pearson in view of Ostrovsky have been fully considered and are persuasive in view of the claim amendments now reciting specifics regarding comparing the tissue characteristic measurement to a predefined parameter. Therefore, the 103 rejection(s) of claim(s) 33-36 and 38-39 using Pearson in view of Ostrovsky has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sherman, see claim rejections above.
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.
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/JG/Examiner, Art Unit 3796
/REX R HOLMES/Primary Examiner, Art Unit 3796
