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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted January 21st, 2025 has been considered by the Examiner.
Claim Objections
Claims 1-5, 8-12 & 14 objected to because of the following informalities:
Claim 1, line 5: “different polarity” should read --different polarities--,
Claim 1, line 9: “electrical energy” should read --the electrical energy--,
Claim 1, line 12: “electrical energy” should read --the electrical energy--,
Claim 1, line 14: “electrical energy” should read --the electrical energy--,
Claim 1, lines 15-16: “electrical energy” should read --the electrical energy--,
Claim 2, line 3: “electrical energy” should read --the electrical energy--,
Claim 3, line 3: “electrical energy” should read --the electrical energy--,
Claim 4, line 3 (both occurrences): “electrical energy” should read --the electrical energy--,
Claim 4, line 4 (both occurrences): “electrical energy” should read --the electrical energy--,
Claim 4, line 5: “different voltage” should read --different voltages--,
Claim 5, line 3: “electrical energy” should read --the electrical energy--,
Claim 5, line 5: “electrical energy” should read --the electrical energy--,
Claim 8, line 3: “electrical energy” should read --the electrical energy--,
Claim 9, lines 2-3: “both user and controller” should read --both the user and the controller--,
Claim 10, lines 2-3: “both user and controller” should read --both the user and the controller--,
Claim 11, lines 2-3: “both user and controller” should read --both the user and the controller--,
Claim 12, line 6: “impedance value” should read --impedance values--,
Claim 12, line 7: “electrical energy” should read --the electrical energy--,
Claim 14, line 7: “electrical energy” should read --the electrical energy--.
Appropriate correction is required.
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.
Claims 1-16 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.
Regarding claim 1, the claim recites “at least a first electrode” in line 6 and it is unclear if this is the same electrode or is a different electrode from the at least a first electrode recited in line 3. For examination purposes, these are the same electrodes and the limitation will be interpreted as “the at least first electrode”.
Regarding claim 1, the claim recites “electrical energy” in line 7 and it is unclear if this is the same electrical energy as recited in line 1 or is a different electrical energy. For examination purposes, these are the same energies and the limitation will be interpreted as “the electrical energy”. For other recitations in claim one and its dependent claims, see Claim Objections section.
Regarding claim 1, the claim recites “the said electrode” in line 9 and it is unclear if this is the same electrode or is a different electrode from the at least a first electrode recited in line 3. For examination purposes, these are the same electrodes and the limitation will be interpreted as “the at least first electrode”.
Claim 1 recites the limitation “the electrical circuit” in line 10. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, the claim recites “a pulse” in line14 and it is unclear if this is the same pulse as a plurality of pulses recited in lines 6-7 or is a different pulse. For examination purposes, these are the same pulses and the limitation will be interpreted as “a pulse of the plurality of pulses”.
Regarding claim 1, the claim recites “a known voltage” in line 14 and it is unclear if this is the same known voltage as that recited in line 7 or is a different known voltage. For examination purposes, these are the same known voltages and the limitation will be interpreted as “the known voltage”
Claims 2-16 are also rejected by virtue of their dependency on claim 1.
Regarding claim 2, the claim recites “said electrode” in line 3 and it is unclear if this is the same electrode or is a different electrode from the at least a first electrode recited in claim 1, from which claim 2 depends. For examination purposes, these are the same electrodes and the limitation will be interpreted as “the at least first electrode”.
Regarding claim 2, the claim recites “a portion of an adjacent tissue” in line 4 and it is unclear if this is the same portion of adjacent tissue or is a different portion of adjacent tissue from the portion of the adjacent tissue recited in claim 1, from which claim 2 depends. For examination purposes, these are the same portions of adjacent tissue and the limitation will be interpreted as “the portion of the adjacent tissue”.
Regarding claim 2, the claim recites “adipose tissue” in lines 4-5 and it is unclear if this is the same adipose tissue or is a different adipose tissue from the adipose tissue layer recited in claim 1, from which claim 2 depends. For examination purposes, these are the same adipose tissues and the limitation will be interpreted as “the adipose tissue layer”.
Regarding claim 3, the claim recites “a known voltage” in line 3 and it is unclear if this is the same known voltage or is a different known voltage from the known voltage recited in claim 1, from which claim 3 depends. For examination purposes, these are the same known voltages and the limitation will be interpreted as “the known voltage”.
Claim 4 recites the limitation “the voltage value” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 5 recites the limitation “the electrode” in line 2. There is insufficient antecedent basis for this limitation in the claim. Additionally, it is unclear if this is the same electrode as the at least first electrode, the at least second electrode or is a different electrode.
Regarding claim 5, the claim recites “a plurality of consecutive pulses” in lines 2-3 and it is unclear if these are the same pulses as the plurality of pulses as recited in claim 1, from which claim 5 depends or are a different set of pulses. For examination purposes, these are different pluralities of pulses.
Claim 5 recites the limitation “the number” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 5, the claim recites “a known voltage” in line 4 and it is unclear if this is the same known voltage or is a different known voltage from the known voltage recited in claim 1, from which claim 5 depends. For examination purposes, these are the same known voltages and the limitation will be interpreted as “the known voltage”.
Claim 5 recites the limitation “the voltage value” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 is also rejected by virtue of its dependency on claim 5.
Regarding claim 7, the claim recites “an impedance value” in line 2 and it is unclear if this is the same impedance value or is a different impedance value from the impedance value recited in claim 1, from which claim 7 depends. For examination purposes, these are the same impedance value and the limitation will be interpreted as “the impedance value”.
Claim 8 recites the limitation “the rate of change” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 8, the claim recites “the voltage” in line 3 and it is unclear if this is the same voltage or is a different voltage from the known voltage recited in claim 1, from which claim 8 depends. For examination purposes, these are the same known voltages and the limitation will be interpreted as “the known voltage”.
Regarding claim 8, the claim recites “the pulses” in line 3 and it is unclear if this is the same pulses or are different pulses from the plurality of pulses recited in claim 1, from which claim 8 depends. For examination purposes, these are the same known voltages and the limitation will be interpreted as “the plurality of pulses”.
Claim 10 recites the limitation “the rate of change” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation “the change” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 10, the claim recites “in 5 value” and it is unclear what this is referring to. The limitation will be interpreted broadly until Applicant either amends or clarifies.
Regarding claim 11, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 12 recites the limitation “the plurality of consecutive pulses” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the rate of change” in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation “the change” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 12, the claim recites “the pulses” in line 7 and it is unclear if this is the same pulses or are different pulses from the plurality of pulses recited in claim 1, from which claim 12 depends. For examination purposes, these are the same known voltages and the limitation will be interpreted as “the plurality of pulses”.
Claim 13 recites the limitation “the rate of change” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation “the change” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 13, the claim recites “a user” in line 7 and it is unclear if this is the same user or a different user from the user recited in line 6. For examination purposes, these are the same users and the limitation will be interpreted as “the user”.
Claim 14 recites the limitation “the rate of change” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation “the change” in line 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 14, the claim recites “at least one electrode” in line 7 and it is unclear if this is the same electrode or a different electrode from the at least first electrode or the at least second electrode recited in claim 1, from which claim 14 depends. For examination purposes, these are the same electrode as the at least first electrode and the limitation will be interpreted as “the at least first electrode”.
Regarding claim 14, the claim recites “an adipose layer” in line 8 and it is unclear if this is the same adipose layer or is a different adipose layer from the adipose tissue layer recited in claim 1, from which claim 14 depends. For examination purposes, these are the same adipose layers and the limitation will be interpreted as “the adipose tissue layer”.
Regarding claim 14, the claim recites “the adjacent tissue” in line 8 and it is unclear if this is the same adjacent tissue or is a different adjacent tissue from the adjacent tissue layer recited in claim 1, from which claim 14 depends. For examination purposes, these are the same known voltages and the limitation will be interpreted as “the adjacent tissue layer”.
Claim 15 recites the limitation “the pulsed electrical energy” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “the duration” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation “the pulsed electrical energy” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4, 7, 9 & 11-15 rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gundert et al. (U.S. Pub. No. 20230240746, earliest effective filing date), herein referred to as “Gundert”.
Regarding claim 1, Gundert teaches an apparatus for determining a voltage of electrical energy for subjecting to an adipose tissue layer for ablation (Abstract: Tissue treatment systems and methods are disclosed), comprising:
at least a first electrode (electrode 108), and at least a second electrode (electrode 140), wherein the at least first electrode and the at least second electrode are spaced apart from each other ([0033]: the return electrode 140 is an implanted electrode, located, e.g., on the catheter 102), and wherein the at least first electrode and the at least second electrode comprise different polarity ([0033]: bipolar energy delivery allows for the use of a lower voltage to achieve the treatment effect, as compared to monopolar energy delivery. In a bipolar configuration, the positive and negative poles are close enough together to provide a treatment effect both at the electrode poles and in-between the electrode poles);
a controller (controls 203 or 503) configured for actuating at least a first electrode to emit a plurality of pulses of known voltage of electrical energy ([0050]: the controller 203 to thereby selectively control whether at any given time the HV capacitor(s) 206 will be charged by the HV power supply 202; [0051]: The HV capacitor(s) 206 include one or more HV capacitors that are used to store the energy that is used to generate the tissue treatment signal that is delivered to a patient via the electrodes 108 and 140; [0074]: The LV power supply 504 is configured to selectively provide a low voltage DC signal that is used to charge up the LV capacitor(s) 206 to a desired voltage level);
a current sensor configured for measuring an electrical current (HV voltage sense circuit 212 & LV voltage sense circuit 512), for each emitted pulse of electrical energy emitted from the said electrode when said pulse extends through a portion of an adjacent tissue completing the electrical circuit ([0066]: low voltage (LV) pulses … high voltage (HV) pulses; [0080]: the HV voltage sense circuit 212 is used to sense the voltage between the active electrode 108 and the return electrode 140 when the HV signal generator 501 is being used and/or is about to be used to generate a HV treatment signal, and the LV voltage sense circuit 512 that is used to sense the voltage between the active electrode 108 and the return electrode 140 when the LV signal generator 503 is being used and/or is about to be used to generate a HV treatment signal; [0091]: Step 606 can be performed, at least in part, using a current sense circuit, such as, but not limited to, the circuits 514 or 214 discussed above; see circuit diagram in Fig. 5D); and
a processor configured for calculating an impedance value (controllers 203 or 503), from the known voltage of the said pulse of emitted electrical energy and the measured electrical current ([0092]: Step 608 involves producing an estimate of an impedance of the patient tissue based on a voltage of the LV tissue impedance measurement signal that is delivered to the patient tissue and based on the current that is measured. Step 608 can be performed, at least in part, by a controller, such as the controllers 203 or 503 discussed above); and for determining a voltage for subjecting to an adjacent tissue layer for ablation, by comparing the calculated impedance value of a pulse of electrical energy of a known voltage with one or more previous calculated impedance values calculated from previously emitted pulses of electrical energy of a different voltage value (see Fig. 6; [0094]: More specifically, steps 604, 606, and 608 can be repeated to produce an updated estimate of the impedance of the patient tissue, and then there can be a determination of whether there was at least a specified reduction (e.g., a reduction of at least 50%) in the impedance of the patient tissue. If there was not at least the specified reduction in the tissue impedance (i.e., if the answer to the determination at step 612 is No), then an additional HV tissue treatment signal is produced and delivered to the same location at another instance of step 610, as could be appreciated from FIG. 6. More specifically, additional instances of steps 604, 606 and 608 can be performed as part of step 612, and then step 610 can be repeated to produce and deliver a further HV tissue treatment signal at the same location (using an updated estimate of tissue impedance produced at the most recent instance of step 608); wherein the voltage is the HV signal, the calculated impedance is from the LV impedance signal with a LV signal).
Regarding claim 2, Gundert teaches wherein the current sensor is configured for measuring an electrical current, from each of the emitted plurality of pulses of electrical energy emitted from said electrode and configured such that the said pulse extends through a portion of an adjacent tissue wherein the adjacent tissue comprises adipose tissue ([0091]: Step 606 involves measuring a current that is delivered to the patient tissue via the active electrode, e.g., 108, while the LV tissue impedance measurement signal is delivered to the patient tissue. Step 606 can be performed, at least in part, using a current sense circuit, such as, but not limited to, the circuits 514 or 214 discussed above; [0066]: low voltage (LV) pulses; [0056]: The HV tissue treatment signals described herein can be used, for example, to deliver therapeutic energy to portions a patient's heart to provide tissue modification, such as to the entrances to the pulmonary veins in the treatment of atrial fibrillation (AF). Targeted specific anatomic locations include … ventricular epicardium).
Regarding claim 3, Gundert teaches wherein the controller is further configured for actuating emitting of at least a first pulse of electrical energy of a known voltage, from any one or more of the following group: the at least first electrode; the at least second electrode, and any subsequent electrode ([0093]: Step 610 involves producing a HV tissue treatment signal and delivering the HV tissue treatment signal via the active and return electrodes … step 610 can include adjusting a voltage in order to treat tissue with a target current; [0089]: An example of such an active electrode is the electrode 108 of the instrument (e.g., catheter) 102 shown in and discussed above with reference to FIG. 1A. Step 602, or a separate step, can also involve applying a return electrode, e.g., 140, externally to the skin of a patient. The return electrode, e.g., 140, can alternatively be an implanted electrode, located, e.g., on the catheter or a sheath, but not limited thereto).
Regarding claim 4, Gundert teaches wherein the controller is further configured for actuating the at least first electrode to emit at least a first pulse of electrical energy, and at least a second pulse of electrical energy, wherein the at least first pulse of electrical energy and the at least second pulse of electrical energy are of different voltage and wherein the voltage value of the at least second said pulse is greater than the voltage value of the at least first or earlier said pulse ([0089]: An example of such an active electrode is the electrode 108 of the instrument (e.g., catheter) 102 shown in and discussed above with reference to FIG. 1A. Step 602, or a separate step, can also involve applying a return electrode, e.g., 140, externally to the skin of a patient. The return electrode, e.g., 140, can alternatively be an implanted electrode, located, e.g., on the catheter or a sheath, but not limited thereto; see steps 602-612 in view of step 616- the electrode 108 remains in position until step 616 decides to reposition; [0090]: step 604 involves producing a LV tissue impedance measurement signal and delivering the LV tissue impedance measurement signal to patient tissue via the active electrode and the return electrode; [0093]: step 610 can include adjusting a voltage in order to treat tissue with a target current … the voltage of the HV tissue treatment signal is at least five times greater than the voltage of the LV tissue impedance measurement signal; see also [0092]).
Regarding claim 7, Gundert teaches wherein the processor is configured for calculating an impedance value Z (step 608; [0092]: Step 608 involves producing an estimate of an impedance of the patient tissue based on a voltage of the LV tissue impedance measurement signal that is delivered to the patient tissue and based on the current that is measured. Step 608 can be performed, at least in part, by a controller, such as the controllers 203 or 503 discussed above), from the known voltage V of the said pulse (step 604; [0090]: step 604 involves producing a LV tissue impedance measurement signal and delivering the LV tissue impedance measurement signal to patient tissue via the active electrode and the return electrode. The LV tissue impedance measurement signal produced at step 604 can be produced using a signal generator, e.g., 104), and the measured electrical current I for each said pulse n (step 606; [0091]: Step 606 involves measuring a current that is delivered to the patient tissue via the active electrode, e.g., 108, while the LV tissue impedance measurement signal is delivered to the patient tissue. Step 606 can be performed, at least in part, using a current sense circuit, such as, but not limited to, the circuits 514 or 214 discussed above; [0092]: Assume for example that the LV tissue impedance measurement signal delivered at step 604 was a 100 V pulse, and that the current measured at step 606 is 0.8 Amps, then the estimate produced at step 608 can be 125 Ohms, because R=100 V/0.8 A=125 Ω); and to monitor the impedance values; and to compare the impedance value Z for each pulse n with the impedance value to, an, or the, earlier emitted pulse (repetition of steps 604-612; [0094]: step 612 involves determining whether the patient tissue treatment at the location was sufficient. In certain embodiments, step 612 can be performed by determining whether the impedance of the patient tissue was reduced by at least a specified amount, since the impedance of successfully treated tissue should be significantly reduced; see entirety of [0094]).
Regarding claim 9, Gundert teaches wherein the processor is further configured for, to signal the controller, or user, or both user and controller, upon detection that, the impedance value Z of the pulse n, decreases, or is less than, in value compared to the impedance value Z of an, or the earlier emitted pulse ([0094]: step 612 involves determining whether the patient tissue treatment at the location was sufficient. In certain embodiments, step 612 can be performed by determining whether the impedance of the patient tissue was reduced by at least a specified amount, since the impedance of successfully treated tissue should be significantly reduced; [0040]: the processor 154 is configured to execute one or more algorithms for running a feedback control loop based on one or more measured system parameters (e.g., current), one or more measured tissue parameters (e.g., impedance); [0094]: step 612 can be performed by determining whether the impedance of the patient tissue was reduced by at least a specified amount, since the impedance of successfully treated tissue should be significantly reduced. More specifically, steps 604, 606, and 608 can be repeated to produce an updated estimate of the impedance of the patient tissue, and then there can be a determination of whether there was at least a specified reduction (e.g., a reduction of at least 50%) in the impedance of the patient tissue).
Regarding claim 11, Gundert teaches wherein the processor is configured for, to signal the controller, or a user, or both a user and controller, that the voltage for subjecting to an adjacent, for example adipose, layer for ablation, is the voltage V of the earlier emitted pulse ([0040]: the processor 154 is configured to execute one or more algorithms for running a feedback control loop based on one or more measured system parameters (e.g., current), one or more measured tissue parameters (e.g., impedance); [0094]: If there was not at least the specified reduction in the tissue impedance (i.e., if the answer to the determination at step 612 is No), then an additional HV tissue treatment signal is produced and delivered to the same location at another instance of step 610, as could be appreciated from FIG. 6; [0056]: The HV tissue treatment signals described herein can be used, for example, to deliver therapeutic energy to portions a patient's heart to provide tissue modification, such as to the entrances to the pulmonary veins in the treatment of atrial fibrillation (AF). Targeted specific anatomic locations include … ventricular epicardium).
Regarding claim 12, Gundert teaches wherein the controller is configured for, that when signalled that the impedance Z for a pulse from the plurality of consecutive pulses, decreases in value, or is less than in value, compared to the impedance value with a, or the, previous emitted pulse ([0040]: the processor 154 is configured to execute one or more algorithms for running a feedback control loop based on one or more measured system parameters (e.g., current), one or more measured tissue parameters (e.g., impedance); [0094]: Still referring to FIG. 6, step 612 involves determining whether the patient tissue treatment at the location was sufficient. In certain embodiments, step 612 can be performed by determining whether the impedance of the patient tissue was reduced by at least a specified amount, since the impedance of successfully treated tissue should be significantly reduced. More specifically, steps 604, 606, and 608 can be repeated to produce an updated estimate of the impedance of the patient tissue, and then there can be a determination of whether there was at least a specified reduction (e.g., a reduction of at least 50%) in the impedance of the patient tissue), or the rate of change of the impedance value compared to the change of the voltage, decreases, or is less than in value to previously calculated rate of change of impedance value, the controller is configured to stop increasing the voltage value of the pulses of electrical energy to be emitted ([0095]: At step 614 there is a determination of whether there is/are any additional patient tissue location(s) to treat. If the answer to the determination at step 614 is No, then the method may end).
Regarding claim 13, Gundert teaches wherein the controller is further configured for, that when signalled that the impedance Z of a pulse from the plurality of pulses, decreases in value, or is less than, compared to the impedance value of a, or the previous emitted pulse ([0040]: the processor 154 is configured to execute one or more algorithms for running a feedback control loop based on one or more measured system parameters (e.g., current), one or more measured tissue parameters (e.g., impedance); [0094]: Still referring to FIG. 6, step 612 involves determining whether the patient tissue treatment at the location was sufficient. In certain embodiments, step 612 can be performed by determining whether the impedance of the patient tissue was reduced by at least a specified amount, since the impedance of successfully treated tissue should be significantly reduced. More specifically, steps 604, 606, and 608 can be repeated to produce an updated estimate of the impedance of the patient tissue, and then there can be a determination of whether there was at least a specified reduction (e.g., a reduction of at least 50%) in the impedance of the patient tissue), or the rate of change of the impedance value compare to the change of voltage, of pulses, decreases, or is less in value compared to previous values of the rate of change of impedance, the controller is configured to indicate to a user, or the controller, or both the controller and a user, that the apparatus is ready for ablation mode ([0094]: If there was not at least the specified reduction in the tissue impedance (i.e., if the answer to the determination at step 612 is No), then an additional HV tissue treatment signal is produced and delivered to the same location at another instance of step 610, as could be appreciated from FIG. 6. More specifically, additional instances of steps 604, 606 and 608 can be performed as part of step 612, and then step 610 can be repeated to produce and deliver a further HV tissue treatment signal at the same location (using an updated estimate of tissue impedance produced at the most recent instance of step 608)).
Regarding claim 14, Gundert teaches wherein the controller is further configured for, that when signalled that the impedance Z has decreased in value, or is less than in value to that determined for a previous emitted pulse from the plurality of pulses comprising increasing voltage ([0040]: the processor 154 is configured to execute one or more algorithms for running a feedback control loop based on one or more measured system parameters (e.g., current), one or more measured tissue parameters (e.g., impedance); [0094]: Still referring to FIG. 6, step 612 involves determining whether the patient tissue treatment at the location was sufficient. In certain embodiments, step 612 can be performed by determining whether the impedance of the patient tissue was reduced by at least a specified amount, since the impedance of successfully treated tissue should be significantly reduced. More specifically, steps 604, 606, and 608 can be repeated to produce an updated estimate of the impedance of the patient tissue, and then there can be a determination of whether there was at least a specified reduction (e.g., a reduction of at least 50%) in the impedance of the patient tissue), or the rate of change of impedance value in relation to the change of voltage of pulses, decreases compare to previous calculated rate of change values of impedance for previously emitted said pulses the controller is configured, to emit electrical energy via at least one electrode to ablate tissue at the determined voltage, for subjecting to an adipose layer or for subjecting to the adjacent tissue ([0094]: If there was not at least the specified reduction in the tissue impedance (i.e., if the answer to the determination at step 612 is No), then an additional HV tissue treatment signal is produced and delivered to the same location at another instance of step 610, as could be appreciated from FIG. 6. More specifically, additional instances of steps 604, 606 and 608 can be performed as part of step 612, and then step 610 can be repeated to produce and deliver a further HV tissue treatment signal at the same location (using an updated estimate of tissue impedance produced at the most recent instance of step 608)).
Regarding claim 15, Gundert teaches wherein the pulsed electrical energy comprises pulses between 10 and 3100 volts ([0058]: the energy is delivered in a bipolar fashion and each pulse is in the range of approximately 100 V to 1900 V, particularly 100 V to 999 V, more particularly approximately 500 V to 800 V, such as 500 V, 550 V, 600 V, 650 V, 700 V, 750 V, 800 V. In other embodiments, the energy is delivered in a bipolar fashion and each pulse is between approximately 50 and 5000 volts, including 250 to 1500 volts; see also [0057]-[0058]).
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Gundert as applied to claim 1 above, and further in view of Adams et al. (U.S. Pub. No. 20220233237), herein referred to as “Adams”.
Regarding claim 5, Gundert fails to disclose wherein the controller is further configured for actuating the electrode to emit a plurality of consecutive pulses of electrical energy wherein the number of the plurality of consecutive pulses is n; and, each pulse has a known voltage V, and wherein the voltage value increases for consecutive pulses of electrical energy, for at least a desired period of time, or for a desired number of consecutive pulses or until a predetermined voltage has been reached or until manually stopped, or until the controller stops any further change of voltage.
However, Adams discloses wherein the controller is further configured for actuating the electrode to emit a plurality of consecutive pulses of electrical energy wherein the number of the plurality of consecutive pulses is n (therapy sections 330; [0054]: A therapy section (e.g., for a duration of 10 milliseconds) may include a plurality of electrical pulses (e.g., 20 pulses, 30 pulses, etc.) generated and delivered by an electroporation generator); and, each pulse has a known voltage V (step 615, Fig. 6), and wherein the voltage value increases for consecutive pulses of electrical energy (steps 625-630, Fig. 6; [0062]: the controller 120 determines a charge voltage based on the first pulse voltage), for at least a desired period of time, or for a desired number of consecutive pulses or until a predetermined voltage has been reached or until manually stopped, or until the controller stops any further change of voltage ([0102]: the charge voltage is computed using equation (2). For example, if the measured pulse voltage of a prior therapy section is low by 100 volts from the target pulse voltage and assuming the generator impedance equal to the tissue impedance, the charge voltage is to be increased by 200 volts. In one implementation, the electroporation ablation system can set the capacitor bank (e.g., capacitor bank 145 in FIG. 4) with a 200-volt increase in the setting, such that the electrical pulse sequence is delivered at a voltage close to the target pulse voltage in the next therapy section; [0066]: the electroporation controller 120 is configured to control the electric field strength of the electric field formed by the electrodes of the catheter 110 to be no higher than 1500 volts per centimeter).
Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Gundert to include the controller of Adams for the purpose of if the electroporation generator does not adjust its charge voltage provided by source component(s), the therapeutic pulse voltage drops over the course of the IRE ablation by as much as 40%. Since the IRE treatment depends on the electric field, the drop of the pulse voltage can potentially impact the effectiveness of the IRE treatment (Adams: [0054]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Gundert in view of Adams as applied to claim 5 above, and further in view of Wilson et al. (U.S. Pub. No. 20170196621), herein referred to as “Wilson”.
Regarding claim 6, Gundert in view of Adams fails to disclose wherein each consecutive pulse increasing in number n has an increasing voltage V value of 0.1 volts.
However, Wilson discloses wherein each consecutive pulse increasing in number n has an increasing voltage V value of 0.1 volts ([0018]: the ramp component 302 causes an RF voltage to ramp, or increase; see Fig. 5 where absent a time component of the increasing voltage (as in, what is the value or range of n), the ramped voltage of Fig. 5 is seen as an increasing voltage value of 0.1 volts at an instance of time). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Gundert in view of Adams to include the controller of Wilson for the purpose of the increasing voltage increasing the impedance of tissue (Wilson: [0018]).
Claims 8 & 10 are rejected under 35 U.S.C. 103 as being unpatentable over Gundert as applied to claim 1 above, and further in view of Wilson.
Regarding claim 8, Gundert fails to disclose wherein the processor is configured to calculate the rate of change of the impedance value in relation to the voltage for the pulses of electrical energy.
However, Wilson discloses wherein the processor (sealing control component 104) is configured to calculate the rate of change of the impedance value in relation to the voltage for the pulses of electrical energy ([0028]: A rate component 308 determines 406 a rate of change for the impedance. For example, the rate component 308 may calculate a current or instantaneous slope for the impedance in Ohms/s; [0020]: measurement component 302 may determine the impedance based on an amount of current that results from a currently applied voltage; [0018]: the ramp component 302 may control the drive circuit 106 of FIG. 1 to provide an initial ramp of an RF voltage applied to electrodes 110 and 112 and, thus, to a load). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the processor of Gundert to include the processor of Wilson for the purpose of the rate of change indicating how quickly the impedance of a tissue is changing during the procedure (Wilson: [0022]).
Regarding claim 10, Gundert fails to disclose wherein the processor is further configured for, to signal the controller, or user, or both controller and user, upon detection that, the rate of change of the impedance value of the said pulse n compared to the change of the voltage values, decreases, or is less than, in 5 value compared to the rate of change of the impedance value of an, or the earlier emitted pulse.
However, Wilson discloses wherein the processor (rate component 308) is further configured for, to signal the controller (sealing control component 104), or user, or both controller and user, upon detection that, the rate of change of the impedance value ([0022]: The rate component 308 is configured to determine a rate of change for the impedance) of the said pulse n compared to the change of the voltage values ([0023] The rate component 308 may determine whether the impedance is increasing according to a predetermined rate of change; [0018]: the ramp component 302 causes an RF voltage to ramp, or increase), decreases, or is less than, in 5 value compared to the rate of change of the impedance value of an, or the earlier emitted pulse ([0024]: the slope regulation component 310 may increase a voltage, frequency, and/or current in order to increase a rate of change and may reduce a voltage, frequency, and/or current in order to reduce a rate of change for the impedance; [0025]: If the slope regulation component 310 determines that the real-time impedance slope does match a predetermined slope, the slope regulation component 310 may maintain a current RF energy). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the processor of Gundert to include the processor of Wilson, for the purpose of varying the impedance slope dynamically for reduced adjacent tissue heating (thermal spread) or for improved tissue heating modulation for finer control over tissue charring and sticking (Wilson: [0011]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Gundert as applied to claim 1 above, and further in view of Viswanathan (U.S. Pub. No. 20230181250), herein referred to as “Viswanathan”.
Regarding claim 16, Gundert fails to disclose wherein the duration of the pulsed electrical energy comprises between 10 and 200 milliseconds.
However, Viswanathan discloses wherein the duration of the pulsed electrical energy comprises between 10 and 200 milliseconds ([0043]: For example, ablation delivery may be completed in time windows of less than about 100 ms, less than about 150 ms, less than about 200 ms, and less than about 250 ms in various embodiments). Therefore, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the controller of Gundert to include the controller of Viswanathan for the purpose of completing delivery of ablation energy within a predetermined time period (e.g., within a heartbeat, a refractory window of a cardiac chamber, and/or the like) (Viswanathan: [0043]).
Conclusion
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/ABIGAIL M ZIEGLER/Examiner, Art Unit 3794
/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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