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 July 24, 2025 have been entered. Applicant’s amendments have overcome the abstract and claim objections, as well as the 112(b) rejections previously set forth in the Non-Final Office Action mailed on 03/25/2025. Currently, claims 1-24 have been amended, claims 27-34 have been newly added, and claims 1-34 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
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 5, 9-10, 12, 17, and 23 are 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.
Claims 5 and 17 recite the limitation "said current" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the frequency" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation " the measurement value" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the measurement value" in line 2. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether the measurement value is a different value from the impedance value cited in claim 1, or if they are the same value. For examination purposes, Examiner will treat both the measurement value and the impedance value as the same value.
Claim 10 recites the limitation "the bipolar-impedance" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the pairs of adjoining electrodes" in lines 5-6. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether the pairs of adjoining electrodes is different from the adjacent electrodes cited previously in the claim, or if they are the same structure. For examination purposes, Examiner will treat both adjacent and adjoining as the same electrode structure.
Claim 10 recites the limitation "bipolar impedance values" in line 5. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether the bipolar impedance values is a different value from the bipolar impedance values already cited previously in the claim, or if they are the same value. For examination purposes, Examiner will treat both bipolar impedance values as the same.
Claim 23 recites the limitation "the values" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the values" in line 3. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether the values is a different value from the impedance values already cited in the claim 13, or if they are the same value. For examination purposes, Examiner will treat both values as the same.
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, 6-7, 12-16, 18-19, 20, and 25-30, 32, 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bryd (W.O. Application No. 2018102376 A1).
Regarding independent claims 1, 13, and 33-34, Byrd discloses 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, 0100),
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 and/or during a treatment cycle (pa. 0060 & Fig. 2).
Regarding claims 2 and 14, Byrd discloses wherein said impedance values are bipolar impedance values of electrode pairs of the subgroup of the plurality of electrodes (pa. 0038).
Regarding claims 3 and 15, Viswanathan discloses wherein the impedance values are determined as response to an alternating voltage and/or at least one voltage pulse (pa. 0059).
Regarding claims 4 and 16, Byrd discloses wherein the determined arcing risk (AR) indexes is based on said impedance values (pa. 0060).
Regarding claims 6 and 18, Byrd 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). Moreover, Examiner is interpreting “proximal” any location that is not in the distal location of the catheter.
Regarding claims 7 and 20, Byrd 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. 0048, 0059), wherein impedance values can be determined from said determined current impedance values for each of the subgroup of electrodes (pa. 0076).
Regarding claim 12, Byrd discloses wherein the measurement unit is configured such that the frequency for determination of bipolar impedance values of the subgroup of electrodes is between 1 kHz and 1 MHz (pa. 0059).
Regarding claim 19, Byrd 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 25, Byrd discloses a computer program (404) product comprising instructions which, when executed by a processor, cause the processor to perform the steps of the method according to claim 13 (pa. 0053, 0062 & Fig. 4).
Regarding claim 26, Byrd discloses a computer readable data carrier (52) storing a computer program product according to claim 25 (pa. 0047).
Regarding claim 27, Byrd discloses wherein said subgroup is formed by at least one particular electrode pair (pa. 0050, 0100).
Regarding claim 28, Byrd discloses wherein the AR index predicts a risk of arcing by the particular electrode pair (pa. 0050, 0060 & Fig. 2).
Regarding claim 29, Byrd discloses wherein the ECU is configured to predict arcing between the particular electrode pair when the AR index exceeds a predetermined arcing threshold (pa. 0060, 0100-0101).
Regarding claim 30, Byrd discloses wherein the AR index is displayed prior to treatment.
Specifically, Byrd discloses calculating the impedance of different catheter electrodes or a group of catheter electrodes (pa. 0050) using the RF ablation generator and the ECU and adjusting said impedance to a target impedance in order to limit/preventing arcing events from occurring during a procedure (pa. 0060, 0102). Moreover, the value of the target impedance is selected to keep a current density value of the catheter electrodes below a threshold current density that also prevents arcing. Both the RF generator and the ECU are connected to a display (34B) (pa. 0047). Therefore, since the display is electrically connected to the systems which calculate and adjust impedance values of the catheter electrodes to prevent arcing, then it is possible for the display to illustrate the monitored impedance to the user.
Regarding claim 32, Byrd discloses a graphical user interface (34B) configured to display impedances (pa. 0060).
Specifically, Byrd discloses calculating the impedance of different catheter electrodes or a group of catheter electrodes (pa. 0050) using the RF ablation generator and the ECU and adjusting said impedance to a target impedance in order to limit/preventing arcing events from occurring during a procedure (pa. 0060, 0102). Moreover, the value of the target impedance is selected to keep a current density value of the catheter electrodes below a threshold current density that also prevents arcing. Both the RF generator and the ECU are connected to a display (34B) (pa. 0047). Therefore, since the display is electrically connected to the systems which calculate and adjust impedance values of the catheter electrodes to prevent arcing, then it is possible for the display to illustrate the monitored impedance to the user.
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 5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Byrd as applied to claims 1 and 13 above, and further in view of Koblish (U.S. Application No. 20190038349 A1).
Regarding claims 5 and 17, Byrd discloses the invention substantially as claimed in claims 1 and 13 and discussed above.
However, Byrd does not disclose wherein the impedance uniformity (IU) indexes are based on said current impedance values.
Koblish, in the same field of endeavor, teaches a system and methods for facilitating assessment of a nature of contact between an electrode assembly of an ablation catheter (abstract). The system comprises a processing device configured to obtain contact impedance values, which may be obtained directly or may be calculated based on electrical parameter measurements such as current measurements, in order to determine whether or not tissue in contact with at least one of the pair of electrodes (pa. 0208, 0226).
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 current measurements to determine impedance uniformity in order to optimize signal transmissions and ensuring efficient power delivery across different frequencies.
Claims 9, 11, 22, 24 and are rejected under 35 U.S.C. 103 as being unpatentable over Byrd 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, Byrd discloses the invention substantially as claimed in claims 1 and 13 and discussed above.
However, Byrd does not disclose wherein the ECU is configured to calculate an AR index for a particular electrode pair x,y from the measurement values of the particular electrode pair x,y from the subgroup of electrodes scaled by the minimum of bipolar impedance measurement values of the particular 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 electrode pair from the bipolar impedance measurement values scaled by the bipolar impedance measurement values of the respective electrodes (pa. 0027). Wham teaches using 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).
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 impedance values to determine arcing risk since they display an inverse relationship.
Regarding claims 11 and 24, Byrd discloses the invention substantially as claimed in claims 1 and 13 and discussed above.
However, Byrd 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 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 use a maximum determined arcing risk as the "overall arcing risk" for safety reasons.
Claims 10 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Byrd 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, Byrd discloses the invention substantially as claimed in claims 1 and 13 and discussed above.
However, Byrd 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 31 is rejected under 35 U.S.C. 103 as being unpatentable over Byrd as applied to claim 1 above, and further in view of Watson (W.O. Application No. 2019046152 A1).
Regarding claim 31, Byrd discloses controlling the impedance of individual electrodes, or a subgroup of electrodes, in order to control the current density on each electrode/subgroup of electrodes, which limits or prevents arcing events (pa. 0100-0101). Moreover, Bryd discloses a display (34B) (pa. 0047).
However, Byrd does not specifically 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 Byrd in order to accurately pinpoint the location of arcing between a pair of electrodes on a catheter shaft in order to alert the user that an unintended discharge event has occur/could occur to allow the user to adjust energy settings/electrode configuration 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, see pages 13-17, filed 07/24/2025, with respect to the 102 rejection of claims 1 and 13 under Viswanathan have been fully considered and are persuasive. Specifically, Applicant’s amendments to claims 1 and 13 to further require the measurement unit to determine the impedance values of a subgroup of the plurality of electrodes, and the ECU being able to calculate arcing risk (AR) indexes prior to treatment is defined over Viswanathan given that it does not contemplate this claimed feature. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-4, 6-7, 12-16, 18-19, 20, and 25-30, 32, 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bryd (W.O. Application No. 2018102376 A1).
Claims 5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Byrd as applied to claims 1 and 13 above, and further in view of Koblish (U.S. Application No. 20190038349 A1).
Claims 9, 11, 22, 24 and are rejected under 35 U.S.C. 103 as being unpatentable over Byrd as applied to claims 1 and 13 above, and further in view of Wham (U.S. Application No. 20070250052 A1).
Claims 10 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Byrd as applied to claims 1 and 13 above, and further in view of Ballakur (W.O. Application No. 2013134133 A1).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Byrd as applied to claim 1 above, and further in view of Watson (W.O. Application No. 2019046152 A1).
It is the Examiner’s position that the newly filed rejections based on the Byrd is tenable for at least the reasoning set forth in the action 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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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794