DETAILED ACTION
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 .
Examiner comment
The claims are part of the originally filed disclosure. However, regarding claims 1 and 8, there is no support in applicant’s specification for the claim language “wherein the updated impedance threshold defines an updated minimum tissue impedance for which the updated IRE protocol can be applied while maintaining Joule’s heating of the tissue within a defined range”. The figures show step 90: change protocol, keeping voltage about IRE threshold. However, this is not related to updating the minimum tissue impedance or maintaining Joule’s heating of the tissue within a defined range. The specification states “If the measured impedance is above the impedance threshold, meaning Joule heating is within acceptable range, then the processor commands the system to perform the IRE using the initial protocol.” However, again, this is not related to updating the minimum tissue impedance, thus it does not disclose the claim language. The specification also states “For example, a safety criterion aiming at minimizing a risk of over-heating tissue is provided, that is based on a minimal impedance measured, where the system chooses a protocol having an impedance threshold that is lower than the minimal measured impedance, so that a resulting electrical current will be below one causing over-heating of tissue. Such a protocol can therefore be used safely, as the expected Joule heating is within an acceptable range.” While this claim language does discuss maintaining Joule’s heating of the tissue within an acceptable range, it Is unclear if this “acceptable range” is a defined range. Also, there is no explanation of an updated impedance threshold or an updated minimum tissue impedance that maintains Joule’s heating within a defined range. The specification describes lowering the impedance threshold, but it does not describe ensuring that the Joule’s heating is maintained within a defined range, which must have an upper limit and a lower limit.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Neal, II et al., US 20160066977, herein referred to as “Neal”.
Regarding claim 1, Neal discloses an irreversible electroporation (IRE) method (Figure 5), comprising: measuring impedance between selected electrodes ([0047]: “In the embodiment shown, the pulses are applied one pair of electrodes at a time, and then switched to another pair.”) of a catheter (Figure 1: electrodes 22) placed in contact with tissue in an organ ([0055]: “the electrodes 22 that have been placed in the patient” and Figure 5: steps 84 and 90 and [0062]); comparing the impedance to an impedance threshold for the IRE protocol that is pre-defined (Figure 5: step 94 and [0072]), wherein the IRE protocol provides delivering a defined dose of energy to the selected electrodes (Figure 5: step 88 and [0061]) and wherein the impedance threshold defines a minimum tissue impedance for which the IRE protocol can be applied while maintaining Joule’s heating of the tissue within a defined range ([0030]-[0032] and [0034]: “One or more electrodes/probes 22 deliver therapeutic energy and are powered by a voltage pulse generator 10 that generates high voltage pulses as therapeutic energy such as pulses capable of irreversibly electroporating the tissue cells.” Wherein delivering pulses capable of IRE maintains Joule’s heating of the tissue within a defined range); based on the measured impedance being less than the impedance threshold (Figure 5: steps 94 and 100 and [0072]-[0073]): updating the IRE protocol by the adjusting at least one parameter of the IRE protocol (Figure 5: step 88 and [0086]), wherein the updated IRE protocol is configured to deliver the defined dose of energy ([0086]); and updating the impedance threshold ([0041]), wherein the updated impedance threshold defines an updated minimum tissue impedance for which the updated IRE protocol can be applied while maintaining Joule’s heating of the tissue within the defined range ([0041] and [0030] and [0034]: “One or more electrodes/probes 22 deliver therapeutic energy and are powered by a voltage pulse generator 10 that generates high voltage pulses as therapeutic energy such as pulses capable of irreversibly electroporating the tissue cells.” Wherein delivering pulses capable of IRE maintains Joule’s heating of the tissue within a defined range); repeating the updating of both the IRE protocol and the impedance threshold until the most updated impedance threshold is less than the impedance measured (Figure 5: step 94 and [0072]-[0073]); and based on the most updated impedance threshold being less than the impedance measured, applying the most updated IRE protocol to the selected electrodes ([0086]).
Regarding claim 2, Neal discloses the IRE method according to claim 1, wherein the IRE protocol defines a plurality of IRE pulses ([0053]) and wherein adjusting the at least one parameter of the IRE protocol includes reducing a pulse width of each of the plurality of IRE pulses ([0024]: “This information provides the user with feedback that can be used to set or adjust the pulse parameters (voltage, pulse length, number of pulses) to tailor the treatment protocol to the specific patient, and/or indicate when a particular electrode pair has satisfied their required ablation dimensions to attain complete coverage of the targeted region. ” and [0086]).
Regarding claim 3, Neal discloses the IRE method according to claim 1, wherein the IRE protocol defines a plurality of IRE pulses ([0053]) and wherein adjusting the at least one parameter of the IRE protocol includes reducing a repetition rate of the plurality of IRE pulses ([0024]: “This information provides the user with feedback that can be used to set or adjust the pulse parameters (voltage, pulse length, number of pulses) to tailor the treatment protocol to the specific patient, and/or indicate when a particular electrode pair has satisfied their required ablation dimensions to attain complete coverage of the targeted region. ” and [0086]).
Regarding claim 4, Neal discloses the IRE method according to claim 1, wherein the IRE protocol defines a plurality of IRE pulses and wherein adjusting the at least one parameter of the IRE protocol includes increasing the number of IRE pulses ([0024]: “This information provides the user with feedback that can be used to set or adjust the pulse parameters (voltage, pulse length, number of pulses) to tailor the treatment protocol to the specific patient, and/or indicate when a particular electrode pair has satisfied their required ablation dimensions to attain complete coverage of the targeted region. ” and [0086]).
Regarding claim 5, Neal discloses the method according to claim 1, wherein the impedance between the selected electrodes is measured and the IRE protocol is updated prior to applying the IRE pulses (Figure 5: step 84 and [0059] and [0061]: “In step 86, based on the received parameters, the treatment control module 54 instructs the controller 71 in the pulse generator 10 to start an electroporation procedure”).
Regarding claim 6, Neal discloses the IRE method according to claim 1, wherein the IRE protocol defines a plurality of IRE pulses and wherein a peak voltage of the IRE pulses in the updated IRE protocol is defined to be the same as that in the IRE protocol that was pre-defined ([0086] and claims 7-8).
Regarding claim 7, Neal discloses the IRE method according to claim 1, wherein the updated impedance threshold is selected to be lower than the impedance threshold associated with the IRE protocol ([0060]: “In some embodiments, the calculated imaginary impedance value may be adjusted down by a selected resistance value (or preselected percentage such as 5-10%) before being stored in the memory 44 as the baseline value in order to account for the fact that the resistance of the tissue cells may decrease by the selected resistance as the applied electroporation pulses increase the temperature of the tissue being ablated.”).
Regarding claim 8, Neal discloses an irreversible electroporation (IRE) system (Figure 1), comprising: an interface configured to exchange signals with a catheter placed in contact with tissue in an organ (Figures 1-2: computer 40 and [0055]: “the electrodes 22 that have been placed in the patient”); and a memory (Figure 2: memory storage 44, program storage 46, and data storage 50 and [0038]) configured to store: an IRE protocol that is configured for delivering a defined dose of energy ([0061]) to selected electrodes of the catheter (Figure 1: electrodes 22 and [0047]: “In the embodiment shown, the pulses are applied one pair of electrodes at a time, and then switched to another pair.”); and an impedance threshold selected for the IRE protocol (Figure 5: step 84 and [0069]-[0070]), wherein the impedance threshold defines a minimum tissue impedance for which the IRE protocol can be applied while maintaining Joule’s heating of the tissue within a defined range ([0030]-[0032] and [0034]: “One or more electrodes/probes 22 deliver therapeutic energy and are powered by a voltage pulse generator 10 that generates high voltage pulses as therapeutic energy such as pulses capable of irreversibly electroporating the tissue cells.” Wherein delivering pulses capable of IRE maintains Joule’s heating of the tissue within a defined range); a processor (Figure 3: controller 71 and [0047]) configured to: measure impedance between the selected electrodes of a catheter placed in contact with tissue in an organ (Figure 5: steps 84 and 90 and [0062]); compare the impedance to an impedance threshold selected for the IRE protocol (Figure 5: step 94 and [0072]); based on the measured impedance being less than the impedance threshold (Figure 5: steps 94 and 100 and [0072]-[0073]): update the IRE protocol by the adjusting at least one parameter of the IRE protocol (Figure 5: step 88 and [0086]), wherein the updated IRE protocol is configured to deliver the defined dose of energy ([0086]); and update the impedance threshold ([0041]), wherein the updated impedance threshold defines an updated minimum tissue impedance for which the updated IRE protocol can be applied while maintaining Joule’s heating of the tissue within the defined range ([0041] and [0030] and [0034]: “One or more electrodes/probes 22 deliver therapeutic energy and are powered by a voltage pulse generator 10 that generates high voltage pulses as therapeutic energy such as pulses capable of irreversibly electroporating the tissue cells.” Wherein delivering pulses capable of IRE maintains Joule’s heating of the tissue within a defined range); repeat the updating of both the IRE protocol and the impedance threshold until the most updated impedance threshold is less than the impedance measured (Figure 5: step 94 and [0072]-[0073]); and based on the impedance measured being less than the impedance measured, apply the most updated IRE protocol to the selected electrodes ([0086]).
Regarding claim 9, Neal discloses the IRE system according to claim 8, wherein the IRE protocol defines a plurality of IRE pulses ([0053]) and wherein adjusting the at least one parameter of the IRE protocol includes reducing a pulse width of each of the plurality of IRE pulses ([0024]: “This information provides the user with feedback that can be used to set or adjust the pulse parameters (voltage, pulse length, number of pulses) to tailor the treatment protocol to the specific patient, and/or indicate when a particular electrode pair has satisfied their required ablation dimensions to attain complete coverage of the targeted region. ” and [0086]).
Regarding claim 10, Neal discloses the IRE system according to claim 8, wherein the IRE protocol defines a plurality of IRE pulses ([0053]) and wherein adjusting the at least one parameter of the IRE protocol includes reducing a repetition rate of the plurality of IRE pulses ([0024]: “This information provides the user with feedback that can be used to set or adjust the pulse parameters (voltage, pulse length, number of pulses) to tailor the treatment protocol to the specific patient, and/or indicate when a particular electrode pair has satisfied their required ablation dimensions to attain complete coverage of the targeted region. ” and [0086]).
Regarding claim 11, Neal discloses the IRE system according to claim 8, wherein the IRE protocol defines a plurality of IRE pulses ([0053]) and wherein adjusting the at least one parameter of the IRE protocol includes increasing the number of IRE pulses ([0024]: “This information provides the user with feedback that can be used to set or adjust the pulse parameters (voltage, pulse length, number of pulses) to tailor the treatment protocol to the specific patient, and/or indicate when a particular electrode pair has satisfied their required ablation dimensions to attain complete coverage of the targeted region. ” and [0086]).
Regarding claim 12, Neal discloses the IRE system according to claim 8, wherein the impedance between the selected electrodes is measured and the IRE protocol is updated prior to applying the IRE pulses to the tissue (Figure 5: step 84 and [0059] and [0061]: “In step 86, based on the received parameters, the treatment control module 54 instructs the controller 71 in the pulse generator 10 to start an electroporation procedure”).
Regarding claim 13, Neal discloses the IRE system according to claim 8, wherein the IRE protocol defines a plurality of IRE pulses and wherein a peak voltage of the IRE pulses in the updated IRE protocol is defined to be the same as that in the IRE protocol stored in the memory ([0086] and claims 7-8)..
Regarding claim 14, Neal discloses the IRE system according to claim 8, wherein the processor is configured to update the impedance threshold by lowering than the impedance threshold associated with the IRE protocol stored in memory ([0060]: “In some embodiments, the calculated imaginary impedance value may be adjusted down by a selected resistance value (or preselected percentage such as 5-10%) before being stored in the memory 44 as the baseline value in order to account for the fact that the resistance of the tissue cells may decrease by the selected resistance as the applied electroporation pulses increase the temperature of the tissue being ablated.”).
Conclusion
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/NORA W RHODES/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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