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
Applicant's submission filed on 06/26/2025 has been entered. Accordingly, claims 1, 3, 6-9, 12-17, and 20 remain pending, and claims 1, 3, 6-9, 12-14, 16, and 17 have been amended.
Response to Arguments
Rejections under 35 USC 112
Applicant's arguments filed 11/12/2025 have been fully considered but they are not persuasive. Applicant’s amendments to claim 1 do not remedy the outstanding issues to claim 1 and have introduced further issues to the claim regarding clarity and introduction of new matter.
Rejections under 35 USC 103
Applicant's arguments filed 11/12/2025 have been fully considered but they are not persuasive.
Regarding the amended and newly presented claim limitations, applicant’s arguments with respect to these specific limitations of claim(s) 1 have been considered, but are moot because the new grounds of rejection has been presented where newly cited portions of the prior art not previously cited are being used in the rejection. Consequently, the arguments do not apply to the new combination cited subject matter of the prior art references being used in the current rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 3, 6-9, 12-17, and 20 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.
Claim 1 has been amended to recite “if determined that the at least one pair of support structures is available, an active impedance value during delivery of energy from one or more electrodes of the respective set of electrodes associated with the at least one pair of support structures to the tissue; and output, via a display of the interactive interface”, in lines 34-38, which renders the claim indefinite because it is unclear if the step of calculating an active impedance value during delivery of energy from one or more electrodes of the respective set of electrodes associated with the at least one pair of support structures to the tissue is required by the claim, as applicant has amended the limitation to be recited in the alternate and appears, but it is unclear, to only be calculated in the event that that the at least one pair of support structures is determined to be available.
Claims 6-8 are also rejected for reciting the same and/or similar limitations outlined above.
All dependent claims are also rejected by the nature of their dependency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 3, and 6-9 are rejected under 35 U.S.C. 103 as being unpatentable over Townley et al. (US20160331459, hereafter “Townley”), in view of Townley and Shields et al. (US20180133460, hereafter “Shields”), further in view of Perfler (US20170151014)
Regarding claim 1, Townley teaches a system for treating a condition within a sino-nasal cavity of a patient, the system comprising:
a treatment device including an end effector comprising a plurality of pairs of support structures (FIGS. 2, 4-5G, 8-9, 214, claim 28, a branch having two struts positioned adjacent to each other), wherein each support structure includes a respective set of electrodes for delivering energy to one or more target sites within the sino-nasal cavity of the patient (see FIGS. 8-9, structures 440 having electrodes 444); and
a console unit operably associated with the treatment device (204 in FIG. 2) and configured to:
receive, via user input with an interactive interface associated with the console unit, a request to initiate treatment of a selected* one of a left side and a right side of the sino-nasal cavity of the patient ([0046] the controller receives control instructions from an operator to initiate, terminate, and/or adjust operation of one or more components, e.g., the energy delivery element);
identify, in response to the request, at least one or pair of support structures to be activated for treating the selected one of the left side and the right side of the sino-nasal cavity ([0054], [0072]-[0073] each electrode can be individually activated and the polarity and amplitude of each electrode can be selected by an operator or a control algorithm (e.g., executed by the controller 218 of FIG. 2), to activate the electrodes 444 in a predetermined pattern selected based on the position of the therapeutic element relative to the treatment site, the specific electrodes are selectively activated which are positioned adjacent to the target tissue by the operator using image guidance to identify which electrodes to activate based on their positioning relative to the target site);
calculate**a treatment pattern for controlling delivery of energy from the respective set of electrodes associated with the at least one pair of support structures identified to be activated in response to the request ([0101] the ablation pattern of the electrodes is based on the neural locations identified via the information detected from the sensing electrodes on the expandable member 856), the treatment pattern comprising a predetermined impedance threshold ([0047], claim 80, claims 83-83, the feedback algorithm, in conjunction with the controller, is configured to automatically terminate treatment after a predetermined maximum impedance rise of the targeted tissue (i.e., in comparison to a baseline impedance measurement, the feedback algorithm, in conjunction with the controller, can be configured to automatically terminate treatment after a predetermined maximum impedance of the targeted tissue, and/or other threshold values for biomarkers associated with autonomic function), a predetermined maximum impedance of the targeted tissue), and/or other threshold values for biomarkers associated with autonomic function, the maximum predetermined maximum impedance rise being the impedance threshold);
for the at least one pair of support structures identified to be activated:
receive feedback data comprises impedance measurement data associated with tissue at the one or more target sites (see FIGS. 8-9, structures 440 having electrodes 444; [0101] feedback provided after therapeutic neuromodulation to confirm the efficacy of the treatment on the targeted nerve to be compared with feedback taken before and during to determine whether the neuromodulation was therapeutically effective for the pattern in which the therapeutic energy was applied and then can again apply therapeutic neuromodulation energy to the same treatment site) within the selected one of the left side and the right side of the sino-nasal cavity ([0096] feedback includes variations in the impedance of different tissue types);
process the feedback data to determine a status*** of the at least one pair of support structures with respect to the treatment pattern ([0096] feedback provides information on a post procedural assessment of the neural activity as a confirmation of effectiveness [being a level or measure of success]), process the impedance measurement data to calculate* at least one of:
a baseline impedance value prior to delivery of energy from the respective set of electrodes associated with the at least one pair support structures to the tissue for the determination of whether the at least one pair of support structures is available ([0089] before the application of a therapeutic neuromodulation energy to determine the presence or location of nerves at the target site and/or record baseline levels of neural activity which indicates the electrode being in an active/available state to deliver neuromodulation energy); and
if determined that the at least one pair of support structures is available, an active impedance value during delivery of energy from one or more electrodes of the respective set of electrodes associated with the last one pair of support structures to the tissue (claims 82, 83, [0093], detecting impedance of tissue at the target site during energy application, the active impedance data can be obtained while actively applying high, medium, and/or low frequencies of energy to the target tissue from the one or more electrodes of an available one of the at least one of the single, pair, or multitude of the plurality of support structures ); but does not specifically disclose output, via a display of the interactive interface, a visual alert, in the form of a color coding pattern, to a user indicating a status of each of the at least one of the pair of support structures, the visual alert comprising a first color indicating an incomplete or unsuccessful state and a second contrasting color indicating a successful state, wherein the visual alert is updated in real-time during energy delivery such that the visual alert changes from the first color to the second contrasting color status upon the at least one pair of support structures transitioning from an incomplete or unsuccessful to a successful state over an elapsed period of time.
However, in the same field of endeavor, Shields teaches output, via a display of the interactive interface, a visual alert in the form of a color coding pattern to a user indicating a status of each of the at least one pair of support structures ([0037], [0059]-[0061], [0099], [0102], FIGS. 3B, 4A-AC, information about the system is communicated to the operator via the display, the anatomical mapping displayed is provided as a color-coded or gray-scale three-dimensional or two-dimensional map showing different intensities of the bioelectric properties to be used during neuromodulation therapy to monitor the treatment progression and after the treatment to validate successful treatment), the visual alert comprising**** a first color indicating an incomplete or unsuccessful state ([0059]-[0061], FIGS. 3B, 4A-4C, expected therapeutically modulated neural structures are differentiated from non-therapeutically modulated neural structures by using different colors as indicators on the display, the ablation pattern mapping defines a region of influence 405 (shown in broken lines) that each electrode 344 has on the surrounding tissue that corresponds to the region of tissue that would be exposed to therapeutically modulating energy based on a defined electrode activation pattern, which corresponds to a device that includes five activated electrodes 344 on each strut 340 [support structure]. The ablation pattern mapping can be used to illustrate the ablation pattern of any number of electrodes 344, any geometry of the electrode layout, and/or any ablation activation protocol, therefore, the cited disclosure has been interpreted to read on the limitations of the claim as one of ordinary skill in the art of neuroanatomical mapping would understand that indicating which targets have not been successfully treated in another and win those unsuccessfully treated targets are treated, the color than would change to the color of the successfully treated targets) and a second contrasting color indicating a successful state ([0059]-[0061], FIGS. 3B, 4A-4C, different visualization features including: color-coding to identify certain anatomical structures, bioelectric properties of the target tissue, etc., and that therapeutically modulated neural structures are shaded to differentiate them from the non-affected neural structures), wherein the visual alert is updated in real-time during energy delivery such that the visual alert changes from the first color to the second contrasting color status upon the at least one pair of support structures transitioning from an incomplete or unsuccessful to a successful state over an elapsed period of time ([0068] the neuromodulation algorithm delivers pulsed RF energy between the different pairs of electrodes in time sequence rotation until it is predicted to be complete until the following conditions are met including but not limited to a predetermined elapsed time is set to a value of 10 seconds).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Townley with the outputting, via a display of the interactive interface, a visual alert in the form of a color coding pattern to a user indicating a status of each of the at least one pair of the plurality of support structures, the visual alert comprising the at least one pair of support structures displayed in a first color indicating an incomplete or unsuccessful state and a second contrasting color indicating a successful state, the visual alert is updated in real-time during energy delivery such that the visual alert changes from the first color to the second contrasting color status upon the at least one pair of support structures transitioning from an incomplete or unsuccessful to a successful state over an elapsed period of time as taught by Shields in order to monitor treatment progression respect to the nerves in other anatomy and to validate successful treatment ([0102] of Shields).
Townley does not explicitly disclose each set of support structures having a leaflet shape.
However, in the same field of endeavor, Perfler teaches each set of support structures having a leaflet shape ([0109]-[0115] FIGS. 2, 5, each support structure 3 is petal/leaflet shaped and each support structure 3 comprises ablation electrode 3b which extends distributed over a circumferential portion of the support structure 3).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Townley with each set of support structures having a leaflet shape as taught by Perfler in order to provide ablation leaflets which are separate and distinct from another ablation leaflet of the ablation head and all the plurality ablation leaflets of the end effector which are connected separately to a separate electric energy generator to cause a radiofrequency ablation under a powered condition of the corresponding ablation electrode of each leaflet to be activated individually to allow a better control of the energy supplied to each leaflet during the operating phase of the catheter ([0114], [0138], [0149] of Perfler).
*For the purposes of examination, the limitation has been interpreted in the alternative and under the broadest reasonable interpretation, requiring the treatment of a left side of the sino-nasal cavity of the patient; or requiring the treatment of a right side of the sino-nasal cavity of the patient; or requiring the treatment of either a left side or a right side of the sino-nasal cavity of the patient; or requiring the treatment of a location with the sino-nasal cavity of the patient inclusive of location located within both or either a left side or a right side.
**For the purposes of examination, the limitation has been interpreted under the broadest reasonable interpretation to include any means, factors, parameters, and/or variables to be used as a basis and/or input to perform a calculation to determine a pattern in which the treatment is applied to a target, as known in the art of therapeutic energy delivery.
***For the purposes of examination, the term has been interpreted as defined by the applicant in [0030] have a meaning which generally includes information pertaining to an incomplete state, a successful state, and an unsuccessful state of each support structures with respect to the treatment pattern.
****For the purposes of examination, the limitation has been interpreted in the alternative requiring the visual alert comprising the at least one of the single, pair, or multitude of the plurality of support structures displayed in a first color indicating an incomplete or unsuccessful state; or requiring the visual alert comprising the at least one of the single, pair, or multitude of the plurality of support structures displayed in a second contrasting color indicating a successful state.
Regarding claim 3, Townley teaches wherein the treatment pattern further comprises a predetermined treatment time ([0047], claim 81, the feedback algorithm, in conjunction with the controller 218, can be configured to automatically terminate treatment after a predetermined maximum time for treatment of the targeted tissue, and/or other threshold values for biomarkers associated with autonomic function) and a level of energy to be delivered from the one or more electrodes ([0045] console can further be configured to generate a selected form and/or magnitude[level] of energy for delivery from the therapeutic assembly to tissue or nerves at the target site).
*For the purposes of examination, the limitation has been interpreted in the alternative, requiring the treatment pattern comprise a predetermined treatment time; or requiring the treatment pattern comprise a level of energy to be delivered from the electrodes; or requiring the treatment pattern comprise a predetermined impedance threshold.
Regarding claim 6, Townley substantially discloses all the limitations of the claimed invention, specifically, Townley discloses wherein the console unit is configured to determine availability of the at least one pair of support structures identified to be activated based on a comparison of the calculated baseline impedance value with a predetermined range of baseline impedance values ([0047] the controller terminates the treatment by deactivation of the electrodes when a predetermined maximum impedance rise of the targeted tissue, i.e., in comparison to a baseline impedance measurement).
Regarding claim 7, Townley substantially discloses all the limitations of the claimed invention, specifically, Townley discloses wherein the at least one pair of support structure is determined to be:
available for applying treatment when the calculated baseline value falls within the predetermined range of baseline impedance values ([0047], claim 83, the application of energy is applied after detecting impedance of tissue at the target site during energy application that is compared the prior detected impedance of tissue at the target site before energy application that is used to define a baseline impedance, thus the electrodes being in an active/available state when this value is compared with the baseline impedance measurement); and
unavailable for applying treatment when the calculated baseline value falls outside the predetermined range of baseline impedance values ([0047], claim 83, the application of energy is terminated when a threshold change in impedance from the baseline impedance is reached, thus the electrodes being in an inactive/unavailable state when this value is compared with the baseline impedance measurement).
Regarding claim 8, Townley teaches wherein the feedback data further comprises an elapsed time of delivery of energy from the one or more electrodes of the respective set of electrodes associated with the available one of the at least one pair support structures to the tissue ([0047] the evaluation/feedback algorithm, in conjunction with the controller, can be configured to automatically terminate treatment after a predetermined maximum time, therefore Townley determines an elapsed time by making a determination in comparison with the predetermined maximum time).
Regarding claim 9, Townley substantially discloses all the limitations of the claimed invention, specifically, Townley discloses wherein the console unit is configured to compare the elapsed time with the predetermined treatment time to determine a status of the at least one of pair of support structures ([0047] the evaluation/feedback algorithm, in conjunction with the controller, can be configured to automatically terminate treatment after a predetermined maximum time, which causes and determines the state/status of the at least one electrode to be inactive).
Claim(s) 12-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Townley, in view of Shields and Perfler, as applied to claim 1 above, further in view of Cadouri (US20150112321).
Regarding claim 12, Townley substantially discloses all the limitations of the claimed invention, but does not explicitly disclose wherein, if the elapsed time is less than the predetermined treatment time, the console unit is configured to process the active impedance value to determine a status of the at least one pair of support structures.
However, in the same field of endeavor of intraluminal therapeutic catheter design and construction, Cadouri teaches wherein, if the elapsed time is less than the predetermined treatment time, the console unit is configured to process the active impedance value to determine a status of the at least one pair of support structures ([0124] impedance data is taken for a predetermined sample time interval (e.g., 20 seconds), at a shorter time interval (e.g., every 1.5 seconds), the standard deviation of the active impedance data is calculated).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Townley with in the event the elapsed time is less than the predetermined treatment time, the console unit being configured to process the active impedance value to determine a status of the at least one pair of support structures taught by Cadouri in order to alert a user of the medical device in the event the active impedance measurements is greater than or equal to a pre-determined value (see [0123] of Cadouri).
Regarding claim 13, Townley, in view of Cadouri, substantially discloses all the limitations of the claimed invention, specifically, Cadouri discloses wherein the processing of the active impedance value comprises using an algorithm to determine* whether the least one pair of support structures is in at least one of a successful state based on a comparison* of the active impedance value with at least one of a predetermined minimum impedance value ([0077]-[0078 one or more evaluation/feedback algorithms are used to process the active impedance value to determine the success of the treatment based on a comparison/change in relation to a minimum impedance value).
*For the purposes of examination, the limitation has been interpreted in the alternative, requiring the algorithm to determine whether one or more support structures is in a successful state, or requiring the algorithm to determine whether the one or more support structures is in an unsuccessful state; and requiring the determination be based on a comparison of the active impedance value with a predefined minimum impedance value, or requiring the determination be based on a comparison of the active impedance value with a predetermined low terminal impedance value, or requiring the determination be based on a comparison of the active impedance value with a predetermined high terminal impedance value.
Regarding claim 14, Townley, in view of Cadouri, substantially discloses all the limitations of the claimed invention, specifically, Cadouri discloses wherein the console unit determines the at least one pair of structures to be in an unsuccessful state if the active impedance value is less than the predetermined minimum impedance value ([0076], [0107], indications of impedance measurement or change that is outside of the accepted or expected threshold [less than] are predetermined , therefore not accepted and is unsuccessful) and disables energy delivery from electrodes of the respective set of electrodes associated with the at least one pair of support structures ([0076] energy delivery from these electrodes is to be stopped, therefore the energy delivery will be disabled).
Regarding claim 15, Townley, in view of Cadouri, substantially discloses all the limitations of the claimed invention, specifically, Cadouri discloses wherein, if the active impedance value is greater than the predetermined minimum impedance value and greater than the predetermined low terminal impedance value ([0107], [0118]-[0119], FIG. 9, when a high impedance is detected when the power signal of the circuit is relatively low, which is known in the art electrical engineering to correspond to also a low terminal impedance value, therefore the cited disclosure reads upon limitations as claimed), the console unit is configured to calculate a slope change for the detection of a slope event ([0094]-[0101] derivatives of the rate of change of impedance being monitored and calculated such that the power output is reduced when the active impedance value is greater than/comparison to the predetermined minimum impedance).
Regarding claim 16, Townley, in view of Cadouri, substantially discloses all the limitations of the claimed invention, specifically, Cadouri discloses wherein, upon detecting a slope event, the console unit:
determines that the at least one of the pair of support structures to be in a successful state if a negative slope event is detected and disables energy delivery from electrodes of the respective set of electrodes associated with the least one pair of support structures ([0084]-[0085], [0107], claim 13, the algorithm may adjust and/or terminate or discontinue the current command output when the measured impedance exceeds an impedance threshold, exceeds a relative threshold rising above the baseline value used to determine the rate of change for the impedance measurement causing the current delivered to the electrode to be reduced or disabled); and
determines the at least pair of support structures to be in an unsuccessful state if a negative slope event is not detected and disables energy delivery from electrodes of the respective set of electrodes associated with the at least one pair of support structures ([0107] the algorithm may adjust and/or terminate or discontinue the current command input, which disables energy delivery from the electrodes associated with support structures when measured impedance falls outside of it impedance threshold/is lower than, indicating an unsuccessful state for the support structures).
Regarding claim 17, Townley, in view of Cadouri, substantially discloses all the limitations of the claimed invention, specifically, Cadouri discloses wherein, in the absence of detecting a slope event, the console unit determines the at least one of the pair of support structures to be in an in an unsuccessful state if the active impedance value is greater than the predetermined high terminal impedance value ([0084]-[0107], claims 17-18, 32-36, the algorithm monitoring active impedance) and disables energy delivery from electrodes of the respective set of electrodes associated with the at least one of the pair of support structures ([0074]-[0076], [0089], [0107], claims 32-36).
Regarding claim 20, Townley, in view of Cadouri, substantially discloses all the limitations of the claimed invention, specifically, Cadouri discloses wherein the visual alert further comprises indicating each of the incomplete state ([0078] the feedback provided indicating the unsuccessful status of the treatment provides a simple notification to recommend a particular parameter of the treatment and replacement of the energy delivery elements that may be modified for subsequent treatment), successful state, and unsuccessful state ([0078] feedback may be provided via the display to alert the clinician of the unsuccessful status of the treatment).
It would have been obvious to one ordinarily skilled in the art before the effective filing date of the claimed invention to modify the system disclosed by Townley with the visual alert further comprising indicating each of the incomplete state, successful state, and unsuccessful state as taught by Cadouri in order to alert the user to the outcome of an operation including the reasons for the outcome so that the user can take time to adjust the process run test or take other actions as may appropriate based on the information presented in the alert (see [0110] of Cadouri).
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 AMY SHAFQAT whose telephone number is (571)272-4054. The examiner can normally be reached Monday-Friday 9:30AM-5:30PM MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.S./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798