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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show the illustration accompanying Fig. 1D of the various waveforms through which pulsed field ablation (PFA) may be delivered as described in the Specification [pa. 0021]. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 19 recites the limitation "the data processor" in line 24. There is insufficient antecedent basis for this limitation in the claim. Claim 20 is also rejected because it is dependent on claim 19. Appropriate correction is required.
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 1-17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Karmarkar (U.S. Application No. 20180214204 A1), and further in view of Wilton (U.S. Patent No. 6217574 B).
Regarding independent claim 1, Karmarkar discloses a method comprising:
providing an ablation system having (i) an ablation catheter (70) having a plurality of antenna/sensor electrodes (40) at a distal end (in the embodiment which discloses a plurality of discrete elements, such as a plurality of spaced apart electrodes, pa. 0120-0121); (ii) a plurality of ablation generators (e.g., direct current (DC) sources or alternating current (AC) sources such as radiofrequency, RF, or current sources) that are each configured to generate ablation signals (pa. 0121); (iii) a vector network analyzer (VNA) (pa. 0004, 0120 & Fig. 6); (iv) a filtering system (i.e., an interface circuit comprising a low pass and a high pass filter) having a plurality of channels (pa. 0129 & Fig. 7); and (v) a transmission system (50) (pa. 0120); wherein the transmission system individually electrically couples each of the plurality of antenna/sensor electrodes to at least one ablation generator in the plurality of ablation generators and one discrete VNA, through one discrete channel in the plurality of channels in the filtering system (pa. 0120); wherein the VNA is configured to (A) transmit sensing signals (i.e., an incident signal) across a spectrum of frequencies (pa. 0113, 0129); (B) measure transmit power for the transmitted signals and measure received power for reflected-back signals (i.e., reflection signals) by monitoring changes in magnitude and phase (pa. 0146); and (C) from the measured transmit power and measured received power, calculate high-frequency electrical parameters (HFEPs) (i.e., reflection and transmission electrical properties of the antenna-including, for example phase angle and return loss) (pa. 0129, 0151-0152); and wherein each channel in the filtering system prevents ablation signals from interfering with sensing signals (pa. 0129);
navigating the ablation catheter to a target treatment region within a patient (pa. 0159);
with the VNA, capturing baseline HFEPs for each antenna/sensor electrode (pa. 0136 & Fig. 13);
positioning the ablation catheter to be in at least partial contact with target tissue (pa. 0136);
with the VNA, capturing updated HFEPs for each antenna/sensor electrode (pa. 0007, 0134, 0136);
identifying, from the updated HFEPs, a first subset of antenna/sensor electrodes that are in contact with the target tissue and a second subset of antenna/sensor electrodes that are not in contact (i.e., in blood or saline) with the target tissue (pa. 0005, 0118, 0132); and
with a subset of the ablation generators, providing ablation signals once antenna/sensor electrode-tissue contact is confirmed and maximalized (pa. 0136).
However, Karmarkar does not disclose a plurality of vector network analyzers (VNAs), and wherein the transmission system individually couples each of the plurality of antenna/sensor electrodes to one discrete ablation generator in the plurality of ablation generators and one discrete VNA in the plurality of VNAs.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added additional cables to the transmission system of Karmarkar and to have added additional VNAs to the existing VNA of Karmarkar, in order to allow for individual electrical coupling between each discrete ablation generator of the plurality of ablation generators to one of the antenna/sensor of the plurality of antenna/sensor electrodes and to one discrete VNA in the plurality of VNAs, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
However, Karmarkar does not disclose selectively providing ablation signals to the first subset of antenna/sensor electrodes but not to the second subset of antenna/sensor electrodes.
Wilton, in the same field of endeavor, teaches an RF ablation system comprising an electrode catheter (10), an RF generator (7), and a signal processor (6) (see Fig. 1). The signal processor receives signals indicative of the impedance associated with each electrode member on the electrode catheter, compares those impedance signals and determines which electrode members are associated with the highest impedances. The signal processor then automatically activates the RF generator to generate an RF ablation current and to transmit that current only to those electrode members determined to be in best contact with the myocardium (Col. 12, lines 17-25).
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 signal processor of Wilton to the system of Karmarkar for the purpose of selectively providing ablation signals only to a specific subset of electrodes in order to prevent unwanted injury to the patient and to provide a more efficient ablation method once full contact is established between the electrode and the target tissue.
Regarding claim 2, Karmarkar/Wilton combination discloses the HFEPs comprise a first phase-reversal frequency parameter, FR1 (i.e., a parameter captured at any point before, during, and/or after the application of energy to the tissue (Karmarkar, pa. 0133 & Fig. 10A)), and a second phase-reversal frequency parameter, FR2 (i.e., another parameter captured at any point before, during, and/or after the application of energy to the tissue (Karmarkar, pa. 0133 & Fig. 10B)), for each antenna/sensor electrode.
Regarding claim 3, Karmarkar/Wilton combination discloses wherein identifying the first subset of antenna/sensor electrodes that are in contact with the target tissue comprises determining that FR1 and FR2 parameters in the updated HFEPs (i.e., when the antenna/sensor electrode is in contact with the target tissue, before and/or after the application of energy) are each greater than corresponding FR1 and FR2 parameters in the baseline HFPEs (i.e., when the antenna/sensor electrode is in blood, before and/or after the application of energy) by a threshold frequency.
In this case, when the antenna/sensor electrode is in blood without RF energy, the FR1 parameter in the baseline HFPEs is˜325 MHz and when the antenna/sensor electrode is in blood and RF energy is applied, the FR2 parameter in the baseline HFPEs drops to ˜200 MHz (Karmarkar, pa. 0133). When the electrode is in contact with tissue and no RF energy is applied, the FR1 parameter in the updated HFEPs is ˜400 MHz (see Figs. 11A-11B), on onset of the RF ablation the FR2 parameter in the updated HFEPs drops to ˜250 MHz (Karmarkar, pa. 0134). Examiner will be interpreting the threshold frequency as the difference between the phase-reversal frequency parameter from the updated and the phase-reversal frequency parameter from the baseline HFEPs.
Regarding claim 4, Karmarkar/Wilton combination discloses wherein the threshold frequency is 30 MHz.
As explained above, the threshold frequency is interpreted as the difference between values. The threshold frequency equals the difference between the FR1 from the updated HFEPs and the FR1 from the baseline HFEPs, which is 75 MHz (i.e., 400-325), and the threshold frequency between the FR2 from the updated HFEPs and the FR2 from the baseline HFEPs is 50 MHz (i.e., 250-200). However, in regards to the threshold frequency between the FR2 from the updated HFEPs and the FR2 from the baseline HFEPs, since the FR2 parameter in the baseline HFPEs drops to ˜200 MHz, then it’s a fair to assume that the FR2 parameter in the baseline HFPEs could be any value between 325 and 200. Therefore, in an example where at a point in time the FR2 parameter in the baseline HFPEs is ˜220 MHz, then the threshold frequency between the FR2 from the updated HFEPs and the FR2 from the baseline HFEPs could be 30 MHz (i.e., 250-220); thereby, meeting the claim limitation.
Regarding claim 5, Karmarkar/Wilton combination discloses wherein the threshold frequency is between 25 MHz and 50 MHz.
As explained above, the threshold frequency between the FR1 from the updated HFEPs and the FR1 from the baseline HFEPs is 75 MHz (i.e., 400-325), and at a point in time the threshold frequency between the FR2 from the updated HFEPs and the FR2 from the baseline HFEPs could be 50 MHz (i.e., 250-200); thereby meeting the claim limitation.
Regarding claim 6, Karmarkar/Wilton combination discloses further comprising:
with the VNA, capturing ablation-progress HFEPs (i.e., any HFEPs captured at any point during the application of energy to the tissue when the antenna/sensor is in contact with the tissue);
determining from the ablation-progress HFEPs whether ablation parameters (A) meet clinical objectives, (B) indicate a likelihood of adverse events, or (C) do not yet meet clinical objectives (Karmarkar, pa. 0134); and
if ablation parameters are determined to meet clinical objectives, stopping the selective application of ablation energy (Karmarkar, pa. 0136); if the ablation parameters are determined to indicate a likelihood of adverse events either adjusting the selective application of ablation energy or stopping the selective application of ablation energy (Karmarkar, pa. 0137, 0148); and if the ablation parameters are determined to not yet meet clinical objectives, continuing the selective application of ablation energy (Karmarkar, pa. 0148).
Regarding claim 7, Karmarkar/Wilton combination discloses wherein determining that ablation parameters meet clinical objectives comprises determining that FR1 parameters in the ablation-progress HFEPs (i.e., when the antenna/sensor electrode is in contact with the target tissue, after the initial application of energy, see Fig. 11C which shows the FR1 parameter to be gradually increasing to ˜400 MHz) are greater than corresponding FR1 parameters in the updated HFPEs (i.e., when the antenna/sensor electrode is in contact with the target tissue, at the beginning of the application of energy, see Fig. 11B which shows the FR1 parameter to be ˜250 MHz) by a first threshold frequency, and FR2 parameters in the ablation-progress HFEPs (i.e., when the antenna/sensor electrode is in contact with the target tissue, towards the end of the application of energy, see Fig. 11E which shows the FR2 parameter to be gradually steading at ˜800 MHz) are greater than corresponding FR2 parameters in the updated HFPEs (i.e., when the antenna/sensor electrode is in contact with the target tissue, towards the middle of the application of energy, see Fig. 11D which shows the FR2 parameter to be gradually increasing to ˜600 MHz) by a second threshold frequency (Karmarkar, pa. 0134).
Examiner will be interpreting the first and the second threshold frequencies as the differences between the phase-reversal frequency parameter from the ablation-progress HFEPs and the phase-reversal frequency parameter from the updated HFEPs.
Regarding claim 8, Karmarkar/Wilton combination discloses wherein the first threshold frequency is about 30 MHz, and the second threshold frequency is about 20 MHz.
In this scenario, since the limit of the FR1 parameters in the ablation-progress HFEPs is ˜400 MHz (since its gradually increasing from ˜250 MHz), then the FR1 parameters in the ablation-progress HFEPs could be any value between 250 and 400. In an example where at a point in time the FR1 parameters in the ablation-progress HFEPs is ˜280 MHz, then the first threshold could be 280-250 = 30 MHz.
Furthermore, since the limit of the FR2 parameters in the ablation-progress HFEPs is ˜800 MHz (since its gradually increasing from ˜600 MHz), then the FR2 parameters in the ablation-progress HFEPs could be any value between 600 and 800, and since the limit of the FR2 parameters in the updated HFEPs is ˜600 MHz (since its gradually increasing from ˜400 MHz) then the FR2 parameters in the updated HFEPs could be any value between 400 and 600. In an example where at a point in time the FR2 parameters in the ablation-progress HFEPs is ˜610 MHz and FR2 parameters in the updated HFEPs is ˜590 MHz, then the second threshold could be 610-590 = 20 MHz.
Regarding claim 9, Karmarkar/Wilton combination discloses wherein determining that ablation parameters meet clinical objectives comprises determining that FR1 parameters in the ablation-progress HFEPs (i.e., when the antenna/sensor electrode is in contact with the target tissue, after the initial application of energy, see Fig. 11C which shows the FR1 parameter to be gradually increasing to ˜400 MHz) are greater than corresponding FR1 parameters in the baseline HFPEs (i.e., when the antenna/sensor electrode is in blood before the application of energy, where the FR1 parameters would be ˜325 MHz) by a first threshold frequency, and FR2 parameters in the ablation-progress HFEPs (i.e., when the antenna/sensor electrode is in contact with the target tissue, towards the middle of the application of energy, see Fig. 11D which shows the FR2 parameter to be gradually increasing to ˜600 MHz) are greater than corresponding FR2 parameters in the updated HFPEs (i.e., when the antenna/sensor electrode is in contact with the target tissue, after the initial application of energy, see Fig. 11C which shows the FR2 parameter to be gradually increasing to ˜400 MHz) by a second threshold frequency.
Examiner will be interpreting the first threshold frequency as the difference between the phase-reversal frequency parameter from the ablation-progress HFEPs and the phase-reversal frequency parameter from the baseline HFEPs, and will be interpreting the second threshold frequency as the difference between the phase-reversal frequency parameter from the ablation-progress HFEPs and the phase-reversal frequency parameter from the updated HFEPs.
Regarding claim 10, Karmarkar/Wilton combination discloses wherein the first threshold frequency is about 30 MHz, and the second threshold frequency is about 50 MHz.
In this scenario, the baseline HFPEs is ˜325 MHz, and since the limit of the FR1 parameters in the ablation-progress HFEPs is ˜400 MHz (since its gradually increasing from ˜250 MHz), then the FR1 parameters in the ablation-progress HFEPs could be any value between 250 and 400. In an example where at a point in time the FR1 parameters in the ablation-progress HFEPs is ˜355 MHz, then the first threshold is 355-325 = 30 MHz.
Furthermore, since the limit of the FR2 parameters in the ablation-progress HFEPs is ˜600 MHz (since its gradually increasing from ˜400 MHz), then the FR2 parameters in the updated HFEPs could be any value between 400 and 600, and since the limit of the FR2 parameters in the updated HFEPs is ˜400 MHz (since its gradually increasing from ˜200 MHz) then the FR2 parameters in the updated HFEPs could be any value between 200 and 400. In an example where at a point in time the FR2 parameters in the ablation-progress HFEPs is ˜440 MHz and FR2 parameters in the updated HFEPs is ˜390 MHz, then the second threshold is 440-390 = 50 MHz.
Regarding claim 11, Karmarkar/Wilton combination discloses wherein the ablation system further comprises (vi) a cardiac mapping and navigation system (comprising X-ray, ultrasound, CT or MRI guidance) (Karmarkar, pa. 0141); (vii) a controller (Karmarkar, pa. 0125); and (viii) and a switch that selectively couples or decouples the cardiac mapping and navigation and the transmission system (Karmarkar, pa. 0139);
wherein the controller causes the switch to decouple the cardiac mapping and navigation system and the transmission system when the subset of ablation generators selectively provides ablation signals to the first subset of antenna/sensor electrodes (Karmarkar, pa. 0139).
Regarding claim 12, Karmarkar/Wilton combination discloses wherein positioning the ablation catheter to be in at least partial contact with target tissue comprises positioning the ablation catheter based on information received from the cardiac mapping and navigation system (Karmarkar, pa. 0136, 0141).
Regarding claim 13, Karmarkar/Wilton combination discloses wherein positioning the ablation catheter to be in at least partial contact with target tissue comprises positioning the ablation catheter based on information received from imaging equipment that is external to the ablation system (Karmarkar, pa. 0136, 0141).
Regarding claim 14, Karmarkar/Wilton combination discloses wherein the transmission system comprises a plurality of coaxial cables, wherein a discrete coaxial cable couples each antenna/sensor electrode to a discrete channel in the filtering (Karmarkar, pa. 0120).
Regarding claim 15, Karmarkar/Wilton combination discloses wherein at least one antenna/sensor electrode in the plurality of antenna/sensor electrodes is configured as a spiral antenna/sensor electrode having at least two turns (Karmarkar, pa. 0119 & Fig. 2B).
Regarding claim 16, Karmarkar/Wilton combination discloses wherein the ablation signals are radio-frequency ablation (RFA) signals (Karmarkar, pa. 0125).
Regarding claim 17, Karmarkar/Wilton combination discloses wherein the ablation signals are pulse-field ablation (PFA) signals (Karmarkar, pa. 0121).
Regarding independent claim 19, Karmarkar discloses a method comprising: providing an ablation system having (i) an ablation catheter (70) having a plurality of ablation electrodes and a plurality antenna/sensor electrodes (40) at a distal end (in the embodiment which discloses a plurality of discrete elements, such as a plurality of spaced apart electrodes, pa. 0120-0121); (ii) a plurality of ablation generators (e.g., direct current (DC) sources or alternating current (AC) sources such as radiofrequency, RF, or current sources) that are each configured to generate ablation signals (pa. 0121); (iii) a vector network analyzer (VNA) (pa. 0004, 0120 & Fig. 6); (iv) a filtering system (i.e., an interface circuit comprising a low pass and a high pass filter) having a plurality of channels (pa. 0129 & Fig. 7); and (v) a transmission system (50) (pa. 0120); wherein the transmission system electrically couples each of the plurality of antenna/sensor electrodes to at least one ablation generator in the plurality of ablation generators and one discrete VNA, through one discrete channel in the plurality of channels in the filtering system (pa. 0120); wherein the VNA is configured to (A) transmit sensing signals (i.e., an incident signal) across a spectrum of frequencies (pa. 0113, 0129); (B) measure transmit power for the transmitted signals and measure received power for reflected-back signals (i.e., reflection signals) by monitoring changes in magnitude and phase (pa. 0146); and (C) from the measured transmit power and measured received power, calculate high-frequency electrical parameters (HFEPs) (reflection and transmission electrical properties of the antenna-including, for example phase angle and return loss) (pa. 0129, 0151-0152); and wherein each channel in the filtering system prevents ablation signals from interfering with sensing signals (pa. 0129);
navigating the ablation catheter to a target treatment region within a patient (pa. 0159);
with the VNA, capturing baseline HFEPs for each antenna/sensor electrode (pa. 0136 & Fig. 13);
positioning the ablation catheter to be in at least partial contact with target tissue (pa. 0136);
with the VNA, capturing updated HFEPs for each antenna/sensor electrode (pa. 0007, 0134, 0136);
with the data processor, identifying, from the updated HFEPs, a first subset of antenna/sensor electrodes that are in contact with the target tissue and a second subset of antenna/sensor electrodes that are not in contact (i.e., in blood or saline) with the target tissue (pa. 0112, 0118, 0132); and
with a subset of the ablation generators, providing ablation signals once antenna/sensor electrode-tissue contact is confirmed and maximalized (pa. 0136).
Furthermore, since the plurality of antenna/sensor electrodes disclosed in Karmarkar are capable of both providing RF ablation energy and being transmitters, Examiner is interpreting a number of the plurality of antenna/sensor electrodes to be ablation electrodes and the rest of the plurality of antenna/sensor electrodes to be antenna/sensor electrodes.
However, Karmarkar does not disclose a plurality of vector network analyzers (VNAs), and wherein the transmission system individually couples each of the plurality of antenna/sensor electrodes to one discrete ablation generator in the plurality of ablation generators and one discrete VNA in the plurality of VNAs.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added additional cables to the transmission system of Karmarkar and to have added additional VNAs to the existing VNA of Karmarkar, in order to allow for individual electrical coupling between each discrete ablation generator of the plurality of ablation generators to one of the antenna/sensor of the plurality of antenna/sensor electrodes and to one discrete VNA in the plurality of VNAs, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
However, Karmarkar does not disclose selectively providing ablation signals to the first subset of antenna/sensor electrodes but not to the second subset of antenna/sensor electrodes.
Wilton, in the same field of endeavor, teaches an RF ablation system comprising an electrode catheter (10), an RF generator (7), and a signal processor (6) (see Fig. 1). The signal processor receives signals indicative of the impedance associated with each electrode member on the electrode catheter, compares those impedance signals and determines which electrode members are associated with the highest impedances. The signal processor then automatically activates the RF generator to generate an RF ablation current and to transmit that current only to those electrode members determined to be in best contact with the myocardium (Col. 12, lines 17-25).
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 signal processor of Wilton to the system of Karmarkar for the purpose of selectively providing ablation signals only to a specific subset of electrodes in order to prevent unwanted injury to the patient and to provide a more efficient ablation method once full contact is established between the electrode and the target tissue.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Karmarkar and Wilton as applied to claim 1 above, and further in view of Viswanathan (W.O. Application No. 2019217317 A1).
Regarding claim 18, Karmarkar/Wilton combination discloses the invention substantially as claimed in claims 1 and 17 discussed above.
However, they do not disclose wherein the PFA signals comprise trains of high-voltage pulses of at least 1 KV, delivered at a field strength of at least 100 V/cm.
Viswanathan, in the same field of endeavor, teaches an ablation system comprising an ablation device configured to generate large electric field magnitudes (e.g., electric fields of about 200 V/cm and above) at desired regions of interest to ablate tissue (pa. 0050), and a signal generator (110) able to deliver rectangular- wave pulses with a peak maximum voltage of about 7 kV (pa. 0070).
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 modified the pulse-field ablation (PFA) signals of Karmarkar to comprise trains of high-voltage pulses of at least 1 KV, delivered at a field strength of at least 100 V/cm, as taught by Viswanathan, to aid in therapeutic treatment of a variety of cardiac arrhythmias for example.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Karmarkar and Wilton as applied to claim 19 above, and further in view of Harlev (U.S. Application No. 20090253976 A1).
Regarding claim 20, Karmarkar/Wilton combination discloses the invention substantially as claimed in claim 19 discussed above.
However, they do not disclose wherein each antenna/sensor electrode in the plurality of antenna/sensor electrodes is disposed between two ablation electrodes in the plurality of ablation electrodes.
Harlev, in the same field of endeavor, teaches an ablation catheter device (110) comprising a plurality of spines (116) fitted with various types of electrodes that are configured to perform various functions, such as a plurality of current injection electrodes (119) (analogous to the ablation electrodes) configured to inject electrical current into the targeted tissue, and a plurality of potential measuring electrodes (118) (analogous to the antenna/sensor electrodes) configured to measure the potentials resulting from the current injected by the current injection electrodes (pa. 0128-0129 & Figs. 1-2B). As seen in Figs. 2B-2C, the midpoint section of every other spine contains one current injection electrode; thereby, providing a configuration where each potential measuring electrode in the plurality of potential measuring electrodes is disposed between two spines containing the current injection electrodes in the plurality of current injection electrodes.
It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have modified the arrangement of ablation electrodes and antenna/sensor electrodes on the distal end of the ablation catheter of Karmarkar to have the specific configuration taught by Harlev, since applicant has not disclosed that the specific configuration claimed solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with either configuration of electrodes.
Conclusion
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794