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 amendment filed 06 February 2026 has been entered. Claim 1 is currently amended. Claim 8 is canceled. Claims 1-4 and 19-20 are pending in the application.
Response to Arguments
Applicant's arguments filed 06 February 2026 have been fully considered but they are not persuasive. In light of the amendment to independent claim 1, the previous rejection has been drawn, but a new ground of rejection is made in view of Mun, as previously applied to canceled claim 8.
Applicant's arguments (i.e., that the combination of Townley, Wolf, Ullrich, Avitall, and Mun does not teach or suggest the limitations of claim 1) do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Townley et al. (US PGPub No. 2018/0133460), hereinafter Townley, in view of Wolf et al. (US PGPub No. 2018/0344378), hereinafter Wolf; Ullrich et al. (US PGPub No. 2012/0041436), hereinafter Ullrich; and Avitall et al. (US PGPub No. 2015/0157382), hereinafter Avitall; and further in view of Mun et al. (US 2017/0007308 A1), hereinafter Mun.
Regarding claim 1, Townley teaches a system for treating a condition (Fig. 3A: system 300), the system comprising: a treatment device including an end effector (Fig. 3A: device 302 and evaluation/modulation assembly or element 312) comprising a plurality of electrodes arranged in a substantially symmetrical distribution (par. 0031: “The evaluation/modulation assembly 312 can include at least one electrode 344;” Figs. 3A-3B: electrodes 344 arranged in a substantially symmetrical distribution on radially spaced branches 346) and comprising at least a first pair of bipolar electrodes (par. 0041: “The electrodes 344 can apply bipolar or multi-polar radiofrequency (RF) energy to the target site”);
and a controller operably associated with the treatment device (Fig. 3A: controller 318 and device 302) and configured to:
receive identifying data from the treatment device associated with one or more tissues, the identifying data comprising at least bioelectric properties of the one or more tissues (par. 0038: “the evaluation/modulation assembly 312 can be used to detect resistance, complex electrical impedance, dielectric properties, temperature, and/or other properties that indicate the presence of neural fibers and/or other anatomical structures in the target region”);
process the identifying data to determine one or more types of tissue at a target site to undergo treatment (par. 0038: “the evaluation/modulation assembly 312 and/or other portions of the system 300 can be configured to detect various bioelectric-parameters of the tissue at the target site, and this information can be used by the mapping/evaluation/feedback algorithms 320 to determine the anatomy at the target site (e.g., tissue types, tissue locations, vasculature, bone structures, foramen, sinuses, etc.)”) and further determine one or more treatment patterns corresponding to the one or more types of tissue (par. 0047: “the RF generator can deliver RF power at about 200-300 W to the electrodes 344, and do so while activating the electrodes 344 in a predetermined pattern”);
wherein processing of said identifying data comprises correlating the identifying data with electric signature data of one or more of a plurality of profiles of known tissue types, said electric signature data comprising at least bioelectric properties associated with a plurality of known tissue types, such that a positive correlation between the identifying data and electric signature data results in a positive identification of one or more matching profiles (par. 0038: “the evaluation/modulation assembly 312 and/or other portions of the system 300 can be configured to detect various bioelectric parameters of the tissue at the target site, and this information can be used by the mapping/evaluation/feedback algorithms 320 to determine the anatomy at the target site (e.g., tissue types, tissue locations, vasculature, bone structures, foramen, sinuses, etc.) […] The high degree of resistance detection accuracy provided by the system 300 allows for the detection sub-microscale structures, including the firing of neural structures, differences between neural structures and other anatomical structures (e.g., blood vessels), and even different types of neural structures;” examiner notes that positive correlation between measured and expected data is encompassed by algorithmically determining tissue type at the target site based on detected bioelectric parameters);
initiate a treatment application to be applied via the end effector, wherein the treatment application comprises supplying treatment energy to the one or more of the plurality of electrodes based on a determined treatment pattern to thereby cause two or more of the plurality of electrodes to deliver radiofrequency (RF) energy to corresponding tissue at the target site (Fig. 3B: end effector 312 and electrodes 344 thereon; par. 0079: “Identifying the portions and/or relative positions of the nerves within the interest zone can inform and/or guide selection of one or more treatment parameters (e.g., electrode ablation patterns, electrode activation plans, etc.) of the system 300 for improving treatment efficiency and efficacy” and par. 0041: “The electrodes 344 can apply bipolar or multi-polar radiofrequency (RF) energy to the target site to detect bioelectric properties of the treatment site and/or to therapeutically modulate postganglionic parasympathetic nerves that innervate the nasal mucosa proximate to the target site”);
receive and process, during the treatment application, real-time feedback data associated with targeted tissue at the target site undergoing treatment and receiving RF energy delivered via the two or more of the plurality of electrodes (par. 0037: “The console 304 can also be configured to provide feedback to an operator before, during, and/or after a treatment procedure via mapping/evaluation/feedback algorithms 320 […] the mapping/evaluation/feedback algorithm 320 can include features to confirm efficacy of the treatment and/or enhance the desired performance of the system 300. For example, the mapping/evaluation/feedback algorithm 320, in conjunction with the controller 318 and the evaluation/modulation assembly 312, can be configured to monitor neural activity and/or temperature at the treatment site during therapy and automatically shut off the energy delivery when the neural activity and/or temperature reaches a predetermined threshold (e.g., a threshold reduction in neural activity, a threshold maximum temperature when applying RF energy, or a threshold minimum temperature when applying cryotherapy)”);
the real-time feedback data comprising at least impedance measurement data associated with the targeted tissue at the target site (par. 0103: “The mid-procedure physiological parameter(s) may also be compared to one or more predetermined thresholds, for example, to indicate when to stop delivering treatment energy. In some embodiments of the present technology, the measured baseline, mid-, and post-procedure parameters include a complex impedance”);
and automatically control supply of treatment energy to the two or more of the plurality of electrodes based on the processing of the real-time feedback data (par. 0037: “the mapping/evaluation/feedback algorithm 320, in conjunction with the controller 318, can be configured to automatically terminate treatment after a predetermined maximum time, a predetermined maximum impedance or resistance rise of the targeted tissue (i.e., in comparison to a baseline impedance measurement), a predetermined maximum impedance of the targeted tissue), and/or other threshold values for biomarkers associated with autonomic function”),
to ensure that the delivery of the RF energy from the two or more of the plurality of electrodes results in successful ablation and/or modulation of the targeted tissue (par. 0099: ““The electrical properties of the tissue between the source and the receiver electrodes 344 are measured […] This information can also be used during neuromodulation therapy to monitor treatment progression with respect to the anatomy, and after neuromodulation therapy to validate successful treatment”) whilst minimizing and/or preventing collateral damage to surrounding or adjacent non-targeted tissue at the target site (par. 0099: ““In addition, the anatomical mapping provided by the bioelectrical and/or biopotential measurements can be used to track the changes to non-target tissue (e.g., vessels) due to neuromodulation therapy to avoid negative collateral effects”),
and transmit a signal resulting in an output, via an interactive interface, of a visual alert to a user indicating a status of the efficacy of ablation and/or modulation of the targeted tissue, the alert comprising at least one of a color and text displayed on a graphical user interface (Fig. 3A: display 322; par. 0037: “This and other information associated with the operation of the system 300 can be communicated to the operator via a display 322;” par. 0099: “anatomical mapping can be provided as a color-coded or gray-scale three-dimensional or two-dimensional map”) and indicating whether the ablation/modulation is successful or unsuccessful (par. 0099: “This information can also be used during neuromodulation therapy to monitor treatment progression with respect to the anatomy, and after neuromodulation therapy to validate successful treatment”),
wherein, during the treatment application, the controller is configured to process the real-time feedback data to calculate an active impedance value during delivery of RF energy from the two or more of the plurality of electrodes to the targeted tissue (par. 0054: “Further, complex impedance and/or resistance measurements of the tissue at the region of interest can be detected directly from current-voltage data provided by the bioelectric potential measurements;” examiner notes that detecting impedance from current-voltage data inherently involves calculating the impedance value).
Townley does not explicitly teach wherein the plurality of electrodes comprises a second pair of bipolar electrodes. However, in an analogous art, Wolf teaches a system for treating a condition comprising at least first and second pairs of bipolar electrodes (par. 0024: “Electrodes may comprise one or more monopolar needles, one or more monopolar plates, or one or more bipolar electrode pairs”), which allows for different regions of the treatment element to be activated separately (par. 0093: “In some embodiments of treatment devices comprising an array or multiple pairs of electrodes, each pair of electrodes (bipolar) or each electrode (monopolar) may have a separate, controlled electrical channel to allow for different regions of the treatment element to be activated separately”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Townley by configuring the plurality of electrodes to include a second pair of bipolar electrodes, as taught by Wolf, in order to allow for different regions of the treatment element to be activated separately, as taught by Wolf.
Townley further does not explicitly teach the following claimed elements:
wherein each treatment pattern is for controlling delivery of treatment energy from two or more of the plurality of electrodes to a corresponding one or more types of tissue at the target site based, at least in part, on a predetermined impedance threshold;
wherein the electric signature data comprises impedance profiles with known impedance threshold values associated with successful and unsuccessful ablation and/or modulation treatment of the plurality of known tissue types;
wherein the delivery of RF energy specifically results in sufficient impedance threshold values being attained that are known to be associated with successful ablation and/or modulation of the targeted tissue;
wherein the controller is configured to determine efficacy of ablation of ablation and/or modulation treatment of the targeted tissue based on a comparison of the active impedance value with at least a predetermined minimum impedance value, wherein, if the active impedance value is less than the predetermined minimum impedance value, the controller determines that ablation/modulation is unsuccessful and disables the RF energy delivery from the two or more of the plurality of electrodes, and wherein, if the active impedance value is greater than the predetermined minimum impedance value, the controller calculates a slope change for the detection of a slope event, and, if a negative slope event is detected, the controller determines that ablation/modulation is successful and disables the RF energy delivery from the two or more of the plurality of electrodes, and if a negative slope event is not detected, the controller determines that ablation/modulation is unsuccessful and disables the RF energy delivery from the two or more of the plurality of electrodes.
However, in an analogous art, Ullrich teaches a comparable feedback-enabled electrosurgical system with the following elements:
wherein each treatment pattern is for controlling delivery of treatment energy from two or more of the plurality of electrodes to a corresponding one or more types of tissue at the target site based, at least in part, on a predetermined impedance threshold (par. 0023: “Monitoring impedance at or adjacent to the ablation site and determining completeness of the treatment can be determined according to any criteria. For example, the detection of a particular value of electrical impedance;” examiner interprets the particular value of electrical impedance as a predetermined impedance threshold);
wherein the electric signature data comprises impedance profiles with known impedance threshold values associated with successful and unsuccessful ablation and/or modulation treatment of the plurality of known tissue types (par. 0023: “The ability of the lesion to block electrical signals may be accurately indicated by monitoring the impedance of tissue, which can be measured simultaneously with the creation of the lesion. Accordingly, impedance may be monitored to indicate when ablation is complete and transmural”);
wherein the delivery of RF energy specifically results in sufficient impedance threshold values being attained that are known to be associated with successful ablation and/or modulation of the targeted tissue (par. 0023: “Power source 114 and impedance analyzer 116 work together in order to continuously measure impedance of the target tissue in real time. Real-time impedance measurement permits the user to gauge the completeness, i.e., degree of transmurality, of the heat, ablation, sealing, or dissection treatment”);
wherein the controller is configured to determine efficacy of ablation of ablation and/or modulation treatment of the targeted tissue based on a comparison of the active impedance value with at least a predetermined minimum impedance value, wherein, if the active impedance value is less than the predetermined minimum impedance value, the controller determines that ablation/modulation is unsuccessful and disables the RF energy delivery from the two or more of the plurality of electrodes (see col 11, line 45 – col 12, line 1 of incorporated reference Strul et al., US Patent No. 5,540,681: “RF power is applied to the catheter only during the selected cycle time and only when the impedance is within a preset range (typically 25 to 250 ohms) […] The low impedance and a previously used catheter conditions inhibit any RF power command. In addition to the software controlled limits for temperature, power, and impedance (that turn off power if exceeded), there are also redundant hardware controls”), and wherein, if the active impedance value is greater than the predetermined minimum impedance value, the controller calculates a slope change for the detection of a slope event (see Fig. 4 and col 7, lines 5-24 of incorporated reference Marchlinski et al., US Patent No. 5,562,721: “A substantially linear decrease in impedance was shown in association with rising tissue temperature at the electrode surface induced by the application of RF energy. This pattern was highly reproducible. Accordingly, the tissue impedance monitoring provides reliable information of tissue temperature at the site of energy application via the electrode”), and, if a negative slope event is detected, the controller determines that ablation/modulation is successful and disables the RF energy delivery from the two or more of the plurality of electrodes (par. 0023: “Monitoring impedance at or adjacent to the ablation site and determining completeness of the treatment can be determined according to any criteria” and par. 0033: “tactile mapping logic 118 may output command signals to power source 114. For example, when the impedance of the tissue indicates that ablation is complete, tactile mapping logic 118 may output a command signal to shut down power source 114, thereby preventing delivery of additional energy to the tissue and controlling the behavior of tool 100”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Townley and Wolf by incorporating the specific impedance-related feedback controls taught by Ullrich, since Ullrich teaches that monitoring impedance provides an accurate indication of successful ablation and further teaches that various impedance criteria are known in the art for determining successful ablation (par. 0023). In light of Ullrich’s teaching, one of ordinary skill in the art would have readily recognized that the impedance monitoring and ablation evaluation techniques taught by Ullrich (and the incorporated references therein) were applicable to the invention of Townley and Wolf and would have yielded predictable results and resulted in an improved system, namely, a system that can identify a type of one or more tissues at a target site, identify a corresponding treatment pattern for identified tissues, and automatically control delivery of treatment energy to identified and targeted tissues based on real-time monitoring of impedance feedback data to ensure that ablation is successful.
The combination of Townley, Wolf, and Ullrich does not explicitly teach wherein if a negative slope event is not detected, the controller determines that ablation/modulation is unsuccessful and disables the RF energy delivery from the two or more of the plurality of electrodes. However, Ullrich teaches disabling RF energy delivery after a set amount of time as a safety feature (see Figs. 6A-6B and col 11, lines 43-46 of incorporated reference Strul: “Specific safety features incorporated in the programming of the microprocessor 60 include the following. […] RF power is applied to the catheter only during the selected cycle time”). Examiner notes that the determination whether a negative slope event is detected must depend upon the elapse of a certain amount of time, that is, the controller cannot wait an infinite amount of time but checks for a negative slope event during a particular time period, and if the negative slope event does not occur during that particular time period, the controller determines that it was not detected. Examiner further notes that as Ullrich teaches a negative slope event as an indicator of successful ablation, one of ordinary skill in the art would have readily recognized that the absence of a negative slope event corresponded to unsuccessful ablation. In light of Ullrich’s teaching, it would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the system of the combined reference to disable RF energy delivery after a set amount of time, during which a negative slope event did not occur, as a safety feature.
The combination further does not explicitly teach wherein the efficacy of ablation or modulation treatment is based on comparison of the active impedance value with a predetermined low terminal impedance value or a predetermined high terminal impedance value, wherein each of the predetermined minimum, low, or high terminal impedance values are different and range between approximately 100 Ω and 1 kΩ; or wherein in the absence of detecting a slope event, the controller determines that ablation/modulation is unsuccessful if the active impedance value is greater than the predetermined high terminal impedance value and disables the RF energy delivery from the two or more of the plurality of electrodes. However, in an analogous art, Avitall teaches an ablation system with impedance monitoring wherein efficacy of ablation is based on comparison of the active impedance value with a predetermined low terminal impedance value between 100 Ω and 1 kΩ (Figs. 6A and 6C: active impedance rising above 500 Ω only when good tissue contact indicates high quality ablation; par. 0040: “If the impedance immediately increases (as shown in FIG. 6A), this may indicate that the PV ostium is occluded and the freeze will be of high quality (that is, the PV ostium lesion will be circumferential and permanent) […] if the impedance does not rise or is substantially delayed (as shown in FIG. 6C), this may indicate that the quality of the freeze is low because blood is flowing past the tip of the balloon, preventing the creation of a permanent, circumferential lesion”); and further teaches in the absence of detecting a slope event, determining that ablation/modulation is unsuccessful if the active impedance value is greater than the predetermined high terminal impedance value and disabling the ablation treatment from the device (par. 0041: “impedance may continue to rise even after ice formation. Monitoring this impedance during a cryotreatment procedure (that is, during the circulation of cryogenic fluid within the cryoballoon 26) may help an operator to determine when to stop the cryotreatment procedure. For example, the measured impedance may rise to approximately 2000 Ω within approximately two or three minutes. An impedance value above this level, associated with a longer treatment time, may indicate that the cryotreatment procedure may be causing collateral damage to non-target tissue”).
To provide the system of the combined reference with a predetermined low and high terminal impedance value for evaluating ablation efficacy, as taught by Avitall, would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, for the following reasons:
Townley in view of Wolf and Ullrich teaches a prior art treatment system upon which the claimed invention (evaluating ablation efficacy based on a predetermined low or high terminal impedance value) can be seen as an “improvement” (the combined reference is silent with respect to low or high terminal impedance thresholds for evaluation of ablation efficacy). Avitall teaches a prior art comparable system using a known technique that is applicable to the system of the combined reference, namely, evaluating ablation efficacy based on a predetermined low terminal impedance value, which can indicate the quality of tissue contact and subsequently the quality of lesion formation, or a predetermined high terminal impedance value, which can indicate that collateral damage is occurring in non-target tissue. Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Avitall to the treatment system of the combined reference would have yielded predictable results and resulted in an improved system, namely, a system that could indicate the quality of tissue contact or whether collateral damage is occurring in non-target tissue based on impedance thresholds.
Avitall teaches manually stopping the ablation treatment delivery from the ablation device when the active impedance value is greater than the predetermined high terminal impedance value (par. 0041) and thus does not explicitly teach wherein a controller is configured to perform this step. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the controller to perform the disabling step taught by Avitall, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Townley further does not teach wherein the plurality of profiles of known tissue types is from a supervised and/or an unsupervised trained neural network. However, in an analogous art, Mun teaches an apparatus for discriminating biological tissue wherein the comparison of identifying data with electric signature data comprises correlating the identifying data received from the device with electric signature data from a supervised and/or an unsupervised trained neural network (par. 0009: “a base classifier including a plurality of single classifiers that are different from one another, configured to discriminate what kind of biological tissue the biological tissue is according to a machine learning algorithm having each of the impedance magnitude and the impedance phase measured while changing the frequency wave form as an input variable; and a meta classifier configured to finally discriminate what kind of biological tissue the biological tissue is according to the machine learning algorithm having each biological issue discriminated by the plurality of different single classifiers as an input variable” and par. 0014: “the meta classifier may be a classifier according to an artificial neural network (ANN) algorithm”). Mun also teaches that specific and various machine learning algorithms are known in the art as having the benefit of learning new information and efficiently using the obtained information (par. 0054) and that various well-known machine learning algorithms may be used without limitation for discriminating biological tissue (par. 0073).
In light of Mun’s teachings, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of the combined reference to use an artificial neural network algorithm for correlating identifying data received from the device with electric signature data, with the advantage that the neural network can efficiently use the obtained information, and because an artificial neural network is one of various well-known machine learning algorithms taught by Mun for identifying and discriminating biological tissue.
Regarding claim 2, the combination teaches the system of claim 1 as described previously. Townley further teaches wherein the identifying data is associated with one or more properties of the one or more tissues, the one or more properties comprising at least one of a type, a depth, and a location of each of the one or more tissues (par. 0038: “the evaluation/modulation assembly 312 and/or other portions of the system 300 can be configured to detect various bioelectric-parameters of the tissue at the target site, and this information can be used by the mapping/evaluation/feedback algorithms 320 to determine the anatomy at the target site (e.g., tissue types, tissue locations)”).
Regarding claim 3, the combination teaches the system of claim 2 as described previously. Townley further teaches wherein a subset of the plurality of electrodes is configured to deliver non-therapeutic stimulating energy at a frequency/waveform to respective positions at the target site to thereby sense at least bioelectric properties of the one or more tissues at the target site (par. 0041: “The electrodes 344 can apply bipolar or multi-polar radiofrequency (RF) energy to the target site to detect bioelectric properties of the treatment site and/or to therapeutically modulate postganglionic parasympathetic nerves that innervate the nasal mucosa proximate to the target site” and par. 0046: “In addition, the electrodes 344 can be individually activated to stimulate or therapeutically modulate certain regions in a specific pattern at different times (e.g., via multiplexing), which facilitates detection of anatomical parameters across a zone of interest and/or regulated therapeutic neuromodulation”). Examiner notes that as the stimulating and therapeutic activity of the electrodes are taught as alternatives, the disclosed stimulating energy is non-therapeutic.
Regarding claim 4, the combination teaches the system of claim 3 as described previously. Townley further teaches wherein the bioelectric properties comprise at least one of complex impedance, resistance, reactance, capacitance, inductance, permittivity, conductivity, dielectric properties, muscle or nerve firing voltage, muscle or nerve firing current, depolarization, hyperpolarization, magnetic field, and induced electromotive force (par. 0038: “the evaluation/modulation assembly 312 can be used to detect resistance, complex electrical impedance, dielectric properties, temperature, and/or other properties that indicate the presence of neural fibers and/or other anatomical structures in the target region”).
Regarding claims 19-20, the combination teaches the system of claim 1 as described previously. Townley further teaches wherein the condition comprises a peripheral neurological condition, and the peripheral neurological condition is associated with a nasal condition or a non-nasal condition of the patient (par. 0020: “devices, systems, and methods for mapping, evaluating, and therapeutically modulating neural structures in the nasal region for the treatment of rhinitis”).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794