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 .
Response to Amendment
The Amendments filed May 22, 2026 have been entered. Applicant’s amendments have overcome the 112(b) rejection previously set forth in the Non-Final Office Action mailed on 03/20/2026. Currently, claims 1, 7, 12-13, and 33-34 have been amended, and claims 1-34 are pending in the application.
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 1-7, 12-20, 25-27, 32, 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koblish (U.S. Application No. 20190038349 A1).
Regarding independent claims 1 and 33, Koblish discloses a system (10) for treatment of patient tissue (pa. 0369 & Fig. 1) by delivery of high-voltage pulses (pa. 0367, 0717), comprising:
an ablation catheter (20) (pa. 0366),
a measurement unit (50, 42) (pa. 0369), and
an electronic control unit (ECU) (40) (pa. 0367-0368),
wherein the catheter comprises a catheter shaft, and an ablation portion being arranged at a distal end of the catheter shaft, with a plurality of electrodes (D1, D2, R1, R2) accommodated along the ablation portion (pa. 0595 & Figs. 41B, 45), wherein each of the plurality of electrodes is electrically connected to the measurement unit through the catheter shaft (pa. 0595),
wherein the measurement unit is configured to perform measurements using an energy source (pa. 0251) thereby determining a plurality of impedance values of at least two different pairs of a subgroup of the plurality of electrodes (pa. 0604, 0673),
wherein said subgroup is formed by all or a part of the plurality of electrodes (pa. 0604),
wherein the ECU is configured to receive and analyze said impedance values provided by the measurement unit and calculate a contact uniformity (CU) indexes and/or impedance uniformity (IU) indexes (pa. 0594-0595) for said subgroup of the plurality of electrodes prior and during a treatment cycle (pa. 0670).
Regarding independent claims 13 and 34, Koblish discloses a method for assessment of positions of a plurality of electrodes (D1, D2, R1, R2) (pa. 0595 & Figs. 41B, 45) of an ablation catheter (20) (using one or more imaging technologies) (pa. 0466) for treatment of patient tissue by delivery of high-voltage pulses (pa. 0367, 0717), comprising a catheter shaft having an ablation portion arranged at a distal end of the catheter shaft with the plurality of electrodes accommodated along the ablation portion (pa. 0595), wherein each of the plurality of electrodes is electrically connected to a measurement unit (50, 42) (pa. 0369) through the catheter shaft (pa. 0595), the method comprising:
performing measurements at each electrode in a subgroup of the plurality of electrodes using an energy source (pa. 0251),
determining a plurality of impedance values of at least two different pairs of the subgroup of the plurality of electrodes (pa. 0604, 0673), based on said measurements, wherein said subgroup is formed by all or a part of the plurality of electrodes (pa. 0604),
analyzing said impedance values to calculate a contact uniformity (CU) indexes and/or impedance uniformity (IU) indexes (pa. 0594-0595) for said subgroup of the plurality of electrodes prior and during a treatment cycle (pa. 0670).
Regarding claims 2 and 14, Koblish discloses wherein said impedance values are bipolar impedance values of electrode pairs of the subgroup of the plurality of electrodes (pa. 0673) and/or current impedance values of the subgroup of the plurality of electrodes (pa. 0596).
Regarding claims 3 and 15, Koblish discloses wherein the impedance values are determined as response to an alternating (complex) voltage (pa. 0238, 0673).
Regarding claims 4 and 16, Koblish discloses wherein the determined contact uniformity (CU) indexes is based on said impedance values (pa. 0251).
Regarding claims 5 and 17, Koblish discloses wherein the impedance uniformity (IU) indexes are based on said current impedance values (pa. 0604, 0673).
Regarding claims 6 and 18, Koblish discloses wherein the electronic control unit is arranged proximal to or at the proximal end of the catheter (see Fig. 1), and wherein the measurement unit is connected to or integrated within the ECU (see Fig. 1).
Regarding claim 7, Koblish discloses wherein the measurement unit is configured to determine at least one current bipolar impedance value for each of the subgroup of the plurality of electrodes by measuring the respective current value of one or several of rectangular, sinusoidal, tooth or similar shaped voltage pulses (pa. 0580), wherein one impedance value is determined from said determined at least one current bipolar impedance values for each of the subgroup of electrodes (pa. 251).
Regarding claim 12, Koblish discloses wherein the measurement unit is configured to perform the plurality of measurements at a single frequency using a high voltage energy source (0212, 0249, 251) such that a frequency for determination of the bipolar impedance values of the subgroup of electrodes is between 1 kHz and 1 MHz (pa. 0559).
Regarding claim 19, Koblish discloses wherein the electronic control unit is arranged separate from catheter, and wherein the measurement unit is connected to or integrated within the ECU (see Fig. 1).
Regarding claim 20, Koblish discloses wherein the measurement unit is configured to determine at least one current impedance value for each of the subgroup of the plurality of electrodes by measuring the respective current value of one or several of rectangular, sinusoidal, tooth or similar shaped voltage pulses (pa. 0580), wherein one impedance value is determined from said determined current impedance values for each of the subgroup of electrodes (pa. 0251).
Regarding claim 25, Koblish discloses a computer program product comprising instructions which, when executed by a processor, cause the processor to perform the steps of the method according to claim 13 (pa. 0557).
Regarding claim 26, Koblish discloses a computer readable data carrier (48) storing a computer program product according to claim 25 (pa. 0557).
Regarding claim 27, Koblish discloses wherein said subgroup is formed by at least one particular electrode pair (pa. 0604).
Regarding claim 32, Koblish discloses a graphical user interface configured to display impedances and/or CU indexes (pa. 0233, 0612).
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.
Claims 9, 11, 22, 24, 28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Koblish as applied to claims 1 and 13 above, and further in view of Wham (U.S. Application No. 20070250052 A1).
Regarding claims 9 and 22, Koblish discloses the invention substantially as claimed in claims 1 and 13 and discussed above.
However, Koblish does not disclose wherein the ECU is configured to calculate an AR index for a particular electrode pair x,y from the bipolar impedance values of the particular bipolar electrode pair x,y from the subgroup of electrodes scaled by the minimum of the bipolar impedance values of the particular bipolar electrode pair x, y with one or more adjacent electrodes of the subgroup of the plurality of electrodes.
Wham, in the same field of endeavor, teaches determining the arcing for a particular bipolar electrode pair from the bipolar impedance values scaled by the bipolar impedance measurement values of the respective electrodes (pa. 0017, 0027). Wham further teaches using bipolar impedance values as an indicator for arcing activity, meaning that when impedance is low arcing is high. In step 140 (Fig. 3), an arcing signal is generated by passing the impedance though a high pass and then a low pass filter, with the resulting signal being scaled and capped (pa. 0027-0028).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the bipolar impedance values to determine arcing risk of Wham into the system for treatment of patient tissue of Koblish to further monitor treatment in order to prevent unwanted oscillation in the output of voltage, current and/or power.
Regarding claims 11 and 24, Koblish discloses the invention substantially as claimed in claims 1 and 13 and discussed above.
However, Koblish does not disclose wherein the ECU is configured to calculate an overall risk for arcing for all electrodes of the subgroup based on a maximum of the AR index of all electrode pairs of the subgroup.
Wham, in the same field of endeavor, teaches determining the arcing for a particular bipolar electrode pair from the bipolar impedance values scaled by the bipolar impedance measurement values of the respective electrodes (pa. 0017, 0027), wherein the bipolar impedance values acts as an indicator for arcing activity, meaning that when impedance is low arcing is high. In step 140 (Fig. 3), an arcing signal is generated by passing the impedance though a high pass and then a low pass filter, with the resulting signal being scaled and capped (pa. 0027-0028). Furthermore, Wham teaches calculating (i.e., via controller 24 which includes a microprocessor 25, pa. 0020) an overall risk for arcing for all electrodes of the subgroup based on a maximum of the AR index of all electrode pairs of the subgroup (pa. 0028).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the bipolar impedance values to determine arcing risk of Wham, including the method of calculating the overall risk for arcing based on a maximum, into the system for treatment of patient tissue of Koblish to further monitor treatment in order to prevent unwanted oscillation in the output of voltage, current and/or power, and to prevent the impedance signals from deviating substantially.
Regarding claim 28, Koblish discloses the invention substantially as claimed in claims 1 and 27 and discussed above.
However, Koblish does not disclose wherein the AR index predicts a risk of arcing by the particular electrode pair.
Wham, in the same field of endeavor, teaches determining the arcing for a particular bipolar electrode pair from the bipolar impedance values scaled by the bipolar impedance measurement values of the respective electrodes (pa. 0017, 0027), wherein the bipolar impedance values acts as an indicator for arcing activity, meaning that when impedance is low arcing is high. In step 140 (Fig. 3), an arcing signal is generated by passing the impedance though a high pass and then a low pass filter, with the resulting signal being scaled and capped (pa. 0027-0028). Furthermore, Wham teaches calculating (i.e., via controller 24 which includes a microprocessor 25, pa. 0020) an overall risk for arcing for all electrodes of the subgroup (pa. 0028).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the bipolar impedance values to determine arcing risk of Wham into the system for treatment of patient tissue of Koblish to further monitor treatment in order to prevent unwanted oscillation in the output of voltage, current and/or power.
Regarding claim 30, Koblish discloses a graphical user interface (pa. 0233, 0612), as well as measuring/analyzing impedance values prior to treatment (pa. 0670).
However, Koblish does not disclose wherein the AR index is displayed prior to treatment.
Wham, in the same field of endeavor, teaches calculating an overall risk for arcing for all electrodes of the subgroup (pa. 0028), and a generator (20) which includes one or more display screens for providing the surgeon with a variety of output information (pa. 0018). Examiner is interpreting the ability of a display to show any information, including an AR index, at any point during or before a treatment as a functional limitation. Hence, while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function, because apparatus claims cover what a device is, not what a device does (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated AR index information calculated by Wham into the graphical user interface of Koblish in order to provide additional visual cues/representations to the user of a treatment procedure.
Claims 10 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Koblish as applied to claims 1 and 13 above, and further in view of Ballakur (W.O. Application No. 2013134133 A1).
Regarding claims 10 and 23, Koblish discloses the invention substantially as claimed in claims 1-2 and 13-14 and discussed above.
However, Koblish does not disclose wherein the ECU is configured to calculate the CU indexes for the subgroup of electrodes based on a standard deviation of the bipolar-impedance values of pairs of adjacent electrodes of said subgroup.
Ballakur, in the same field of endeavor, teaches calculating (via computing devices having a processing circuitry such as a microprocessor, pa. 0046) whether sufficient contact/stability has been made between the electrodes and tissue at a target site based on the standard deviation of the bipolar impedance values of pairs of adjacent electrodes (pa. 0072, 00100).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the standard deviation of impedance to calculate contact uniformity since impedance is a good indicator the status of each electrode (e.g., whether the electrode is in a stable position and in good contact with tissue at the target site, whether the electrode has moved out of contact with the tissue) (Ballakur, pa. 0072).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Koblish as applied to claim 1 above, and further in view of Christopherson (U.S. Application No. 20020058933 A1).
Regarding claim 29, Koblish discloses the invention substantially as claimed in claims 1 and 27 and discussed above.
However, Koblish does not disclose wherein the ECU is configured to predict arcing between the particular electrode pair when the AR index exceeds a predetermined arcing threshold.
Christopherson, in the same field of endeavor, a method for detecting arcing using a microprocessor (20) which measures impedance and detected arcs (pa. 0121), and will in turn output signals to control flow rate and RF power. Prior to treatment, a baseline check is conducted (step 232) where the impedance is measured. At step 236, impedance will be remeasured and used to calculate the percentage change (step 238). If the impedance change is less than the threshold, then an error will be indicated at step 242 and the procedure will be halted. If the percentage change is greater than the predetermined percentage change amount, then the measured impedance will be compared with the predetermined, pre-ablation threshold at step 244. If the impedance measurement is less than the pre-ablation impedance threshold then the RF power will be started (pa. 0126, 0129 & Figs. 11-12).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the method of predicting an arcing risk between an electrode pair using an arcing threshold, as taught by Christopherson, into the system for treatment of patient tissue of Koblish for the purpose of further monitoring the application of treatment in order to prevent unwanted oscillation in the output of voltage, current and/or power.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Koblish and Wham as applied to claims 1 and 30 above, and further in view of Watson (W.O. Application No. 2019046152 A1).
Regarding claim 31, Koblish discloses a graphical user interface (pa. 0233, 0612).
However, Koblish does not disclose wherein electrode pairs exhibiting a higher AR index are highlighted.
Watson, in the same field of endeavor, teaches a system for detecting undesirable electrocautery arcing events using an arc detecting camera (94) using filters which enhance the visibility of electrical arcs between electrodes along shaft (136) (pa. 0035, 0043). The resulting images are received by a processing controller (92) which identifies a location and magnitude of arcing occurrences (pa. 0036). The arc detecting camera is connected to an arc detection field-of-view which provides visualization or coverage of potential arc locations on the surgical tools (pa. 0056).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the arc detecting camera of Watson to the system of Koblish in order to accurately pinpoint the location of arcing between a pair of electrodes on a catheter shaft to alert the user that an unintended discharge event has occur/could occur to allow the user to adjust energy settings to avoid future arcing events.
Allowable Subject Matter
Claims 8 and 21 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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: regarding claims 8 and 21, the Bryd (W.O. Application No. 2018102376 A1) reference fail to teach the invention as a whole. The Byrd reference teaches a system for treatment of patient tissue, and a method for assessment of positions and/or configuration of a plurality of electrodes (1414) of an ablation catheter (1400) (pa. 0079, 0082 & Fig. 14) for treatment of patient tissue (pa. 0083), by delivery of high-voltage pulses (pa. 0039), comprising an ablation catheter (14) (pa. 0046 & Fig. 1), a measurement unit (26) (pa. 0059), and an electronic control unit (ECU) (32) (pa. 0047), wherein the catheter comprises a catheter shaft (1404) (pa. 0079), and an ablation portion (1406) being arranged at a distal end (1412) of the catheter shaft (pa. 0083), with a plurality of electrodes (1414) accommodated along the ablation portion (pa. 0083), wherein each of the plurality of electrodes is electrically connected to the measurement unit through the catheter shaft (pa. 0048, 0059), wherein the measurement unit is configured to perform measurements using an energy source (i.e., an RF ablation generator) thereby determining impedance values of a subgroup of the plurality of electrodes (pa. 0050, 0059), wherein said subgroup is formed by all or a part of the plurality of electrodes (pa. 0050), wherein the ECU is configured to receive and analyze said impedance values provided by the measurement unit and calculate arcing risk (AR) indexes for said subgroup of the plurality of electrodes prior to treatment (pa. 0060 & Fig. 2). However, Byrd does not teach calculating an impedance uniformity (IU) of two groups of electrodes using the following formula:
I
U
=
1
-
1
2
σ
Z
d
μ
Z
d
+
σ
Z
p
μ
Z
p
wherein σ(Z_(d,p)) is the standard deviation and μ(Z_(d,p)) is the mean value of the determined impedances of the electrodes of the respective group.
Other pertinent art found not previously cited in prior Office Action is Sun (W.O. Application No. 0078239 A2). Sun teaches a method of assessing the contact quality of multiple groups of electrodes by calculating a "deviation percentage" which is the standard deviation of multiple impedance values over the average impedance, represented as a percentage (page 7, lines 12-23). However, Sun fails to cure the above noted deficiency.
No other pertinent prior art references were found that would overcome the above deficiencies. Therefore, there is no motivation (either in these references or elsewhere in the art) for making such specific and significant modifications thereto to arrive at claims 8 and 21.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments on pages 9-12 regarding independent claims 1 and 13, 33-34 have been fully considered but they are not persuasive. Applicant argues that the Koblish reference does not disclose determining a plurality of impedance values of at least two different pairs of a subgroup of electrodes, and does not calculate AR, CU, or IU indexes for a subgroup of electrodes. Specifically, Applicant contends that Koblish's contact sensing is only performed between a single pair of separated electrode portions, namely the two halves of a split-tip composite electrode (30A and 30B). Furthermore, Applicant asserts that Koblish only discloses a weighted combination of impedance magnitude at a first frequency, the ratio of impedance magnitudes at two frequencies, and the phase of the complex impedance at a second frequency, producing a contact indicator that goes from a 0 to 1 scale for a single pair of electrodes, and that this single-pair contact/no-contact determination is fundamentally different from the claimed AR, CU, and IU indexes, which require aggregating impedance data measured across at least two different pairs of electrodes within a subgroup to assess the uniformity of contact or the risk of arcing across the subgroup of electrodes. However, Examiner respectfully, disagrees.
Koblish discloses different embodiments of a system (10) for treatment of patient tissue (pa. 0369 & Fig. 1), wherein a second embodiment comprises a plurality of electrodes (D1, D2, R1, R2) accommodated along the ablation portion (pa. 0595 & Figs. 41B, 45), wherein each of the plurality of electrodes is electrically connected to the measurement unit through the catheter shaft (pa. 0595). Although a two-electrode impedance measurement technique was described in an embodiment of the previous rejection, three- or four-electrode impedance measurement techniques may be applied with equivalent results in this second embodiment (pa. 0604).
Furthermore, Koblish discloses the measurement unit being configured to perform measurements using an energy source delivering signals at least one frequency (e.g., one frequency, two different frequencies, three different frequencies) configured to facilitate electrical measurements (e.g., direct impedance measurements or impedance values obtained from voltage and/or current measurements) that are in turn used to facilitate electrode-tissue contact assessment (e.g., whether in contact or not or a qualitative assessment of contact state or level) (pa. 0251), thereby determining a plurality of impedance values of at least two different pairs of a subgroup of the plurality of electrodes (pa. 0604, 0673). Lastly, the ECU is configured to receive and analyze said impedance values provided by the measurement unit and calculate a contact uniformity (CU) indexes and/or impedance uniformity (IU) indexes (pa. 0594-0595) for said subgroup of the plurality of electrodes at a single frequency (pa. 0249). Therefore, for the reasonings set-forth above, the rejection using the Koblish reference is maintained.
Applicant's arguments on pages 12-14 regarding dependent claim 12 has been fully considered but they are not persuasive. Applicant argues that the Koblish reference does not disclose the measurement unit is configured to perform the plurality of measurements at a single frequency using a high voltage energy source. Specifically, Applicant contends that performing the plurality of measurements at a single frequency is fundamentally incompatible with Koblish's contact sensing methodology, which depends entirely on obtaining impedance measurements at multiple different frequencies and comparing them. Additionally, Applicant argues that amended claim requires that the measurement unit uses a high voltage energy source. The specification discloses that the system comprises a multi-channel PF energy generator as an energy source, and that Koblish's energy delivery module is an RF ablation generator, not a high voltage pulsed-field energy source as required by the claim. However, Examiner disagrees.
As explained above, Koblish discloses multiple embodiments for measuring impedance and determining contact/impedance uniformity. In the new embodiment set-forth in the rejection above, the first pair of electrodes are bipolar electrodes comprising a pair of spaced-apart ring electrodes that are configured for both high-resolution mapping and tissue ablation. The second set of electrodes comprises a pair of reference ring electrodes that are used for mapping in addition to being used for reference measurements to correct for drift. The signals delivered by the signal source may have at least one frequency (e.g., one frequency, two different frequencies, three different frequencies) configured to facilitate electrical measurements (e.g., direct impedance measurements or impedance values obtained from voltage and/or current measurements) that are in turn used to facilitate electrode-tissue contact assessment (e.g., whether in contact or not or a qualitative assessment of contact state or level) (pa. 0249, 0251). The signal source generates and applies the at least one signal to the pair of electrode members, wherein the signal may be multiple waveforms or signals having a single frequency (pa. 0212).
Furthermore, the claim language of claim 12 is broad and does not require the high voltage energy source to be a multi-channel PF energy generator, as described in the filed Specification of the instant application. Therefore, as long as the high voltage energy source of Koblish is capable of generating signals having a single frequency to a pair of electrodes such that a frequency for determination of the bipolar impedance values of the subgroup of electrodes is between 1 kHz and 1 MHz, then it meets the claim limitation. Therefore, the rejection is maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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