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 01/02/2025 has been entered. Accordingly, claims 1-13 and 16-20 remain pending, and claims 1, 6, 10-13, and 16 have been amended.
Response to Arguments
Double Patenting Rejections
In light of the claim amendments filed 01/02/2026, the double patenting rejections have been rendered moot and have been withdrawn.
Rejections under 35 USC 112
In light of the claim amendments filed on 01/06/2026, the previous rejections of claims 1 and claim 16 for being dependent on canceled claim 14 have been rendered moot and have been withdrawn.
However, with respect to the rejections of claims 6, 10-13, and 16, applicant's arguments filed 01/06/2026 have been fully considered but they are not persuasive.
Applicant has not amended claims 6, 10-13, and 16 to over address the outstanding rejections. The rejections have been updated to incorporate the newly presented claim language. See below.
Rejections under 35 USC 103
Applicant’s arguments filed 01/06/2026 with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 6, 10-13, and 16 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 6 has been amend to recite “a pair support structures is determined to be available for applying treatment, via one or more electrodes of a respective set of electrodes associated with the pair of support structures determined to be available, to one or more target sites when the calculated baseline value falls within the predetermined range of baseline impedance values” and “a pair of support structures is determined to be unavailable for applying treatment, via one or more electrodes of a respective set of electrodes associated the pair of support structures determined to be unavailable, to one or more target sites when the calculated baseline value falls within the predetermined range of baseline impedance values” in lines 2-9, which renders the claim indefinite because it is unclear if the “pair support structures is determined to be available for applying treatment,” and the “pair of support structures is determined to be unavailable for applying treatment” are part of/meant to refer to the plurality of support structures recited in parent claim 1, on which claim 6 depends via claim 5 via claim 2. Similarly, it is unclear if the “a pair of support structures is determined to be unavailable for applying treatment” and “..one or more target sites when the calculated baseline value falls within the predetermined range of baseline impedance values” refer to the earlier recited “pair support structures is determined to be available for applying treatment” and “…one or more target sites when the calculated baseline value falls within the predetermined range of baseline impedance values”.
Claims 10-13 and 16 are also rejected for reciting the same and/or 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) 1-13 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Townley et al. (US20160331459, hereafter “Townley”), in view of Perfler (US20170151014), further in view of Cadouri (US20150112321), Mehta et al. (US20100204695, hereafter “Mehta”), and Mohr et al. (US20100228249A, hereafter “Mohr”).
Regarding claim 1, Townley discloses system for treating a condition within a sino-nasal cavity of a patient, the system comprising:
a treatment device including an end effector comprising (see FIGS. 4, 5F-5G, structures 440 having electrodes 444) a plurality of pairs of support structures (see adjacent support structures 440 in FIGS. 4, 5F-5G, [0075]) including a respective set of electrodes for delivering energy to one or more target sites within the sino-nasal cavity of the patient ([0080], FIGS. 2, 4, 5F-5G, 8-9, 214, claim 28, a branch having two struts positioned adjacent to each other, each having electrode pairs that are configured to sequentially pair with each other); 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 for a determination of availability of the one or more sets of electrodes of corresponding pairs of support structures for applying treatment to one or more target sites within a selected* one of a left side and a right side of the sino-nasal cavity of the patient ([0031], [0046], FIGS. 1A, 5F, 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, at a location within the nasal cavity, which may include one of the left or right side, [0047], [0084], 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, the electrodes on the pairs of support structures can be independently controlled to have the same or opposite polarity or each electrode on each respective support structure may be independently controlled polarity); and
initiate, in response to the request, an impedance assessment of the one or more sets of electrodes within the selected one of the left and right sides of the sino-nasal cavity ([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), wherein the console unit is configured to cycle through the corresponding pairs of support structures and perform an impedance assessment each respective set of electrodes associated with each corresponding pair of support structures ([0080]-[0081] sequential impedance-based pairing of the electrodes 444, portions of the struts 440 themselves can define the electrodes 444); but does not explicitly disclose each support structure having a leaflet shape.
However, in the same field of endeavor, Perfler teaches each support structure 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 support structure 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).
While Townley discloses corresponding pairs of electrodes (see as cited above including but not limited to as seen in [0080]-[0081], [0084], FIGS. 4, 5F-5G) and corresponding pairs of support structures (see as cited above including but not limited to as seen in [0080]-[0081], [0084], FIGS. 4, 5F-5G), Townley does not specifically disclose wherein the console unit is further configured to output, via the interactive interface, an alert to a user indicating a determined availability based on the impedance assessment; wherein said alert comprises at least a visual alert including text displayed via the interactive interface indicating the determined availability.
However, in the same field of endeavor, Cadouri teaches wherein the console unit is configured to cycle through each of the plurality of electrodes and perform an impedance assessment on each ([0125], FIG. 9, the impedance of two or more electrodes can each provide an independent impedance reading);
wherein the console unit is further configured to output, via the interactive interface, an alert to a user indicating a determined availability of each based on the impedance assessment ([0106], [0109] the system is equipped with various audible visual or haptic alarms to alert the operator of conditions relating to the status of the support structures that is displayed on a display screen/interface indicating the status of the likelihood of success or indicating to the user the successful status of the treatment); wherein said alert comprises at least a visual alert ([0106], [0109] the system is equipped with various audible visual or haptic alarms to alert the operator of conditions relating to the status of the support structures that is displayed on a display screen/interface indicating the status of the likelihood of success or indicating to the user the successful status of the treatment) including text displayed via the interactive interface indicating the determined availability ([0076] the appropriate message/text may be displayed on the display include the results and or cessation or modification of treatment protocol indications of impedance measurements and indicate the completion status/state of the treatment [0090] user control can be provided via the user interface, [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 console unit being further configured to cycle through each of the plurality of electrodes and perform an impedance assessment on each and to output, via the interactive interface, an alert to a user indicating a determined availability based on the impedance assessment, wherein said alert comprises at least a visual alert including text and a color coding displayed via the interactive interface indicating the determined availability, 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).
Townley does not explicitly disclose said alert comprises at least a visual alert including a color coding displayed.
However, in the same field of endeavor, Mehta teaches said alert comprises at least a visual alert including text and a color coding displayed ([0218] probe information relating to the virtual array may be color coded on the display).
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 said alert comprises at least a visual alert including text and a color coding displayed as taught by Mehta in order to visually provide to a user a display which a clearly separates the previous treatment location from the current location via visual cues ([0218] of Mehta).
Townley does not explicitly disclose the visual alert comprises a first set of text and first color coding when a corresponding pair of support structures is determined to be available and the visual alert comprises a second set of text and second color coding when a corresponding pair of support structures is determined to be unavailable.
However, in the same field of endeavor, Mohr teaches the visual alert comprises a first set of text and first color coding when a corresponding pair of support structures is determined to be available ([0171], [0188] the right tool type text icon and the swap tool text icon swap positions and colors to indicate the active [available] robotic surgical tool when it is presently controlled by the surgeon's right hand on the right master grip of the surgeon's console, the GUI will then display an active border (e.g., bright or blue in color) on the same side as the energy ball, an active energy ball with an active background or fill color (e.g., bright or blue in color) and an active symbol such as a yellow colored lightning bolt, in contrast to the idle [unavailable] robotic surgical tool) and the visual alert comprises a second set of text and second color coding when a corresponding pair of support structures is determined to be unavailable ([0171], [0188], [0195], in contrast to the idle [unavailable] robotic surgical tool, an inactive border (e.g., dark or brown in color) on the opposite side of the energy ball so that the tool text icon off to the side in the corner of the GUI is smaller in size and color filled to indicate inactive control (e.g., dark or gray or brown colored tab).
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 comprises a first set of text and first color coding when a corresponding pair of support structures is determined to be available and the visual alert comprises a second set of text and second color coding when a corresponding pair of support structures is determined to be unavailable taught by Mohr in order to provide visual feedback by the GUI o indicate the energy status of an electrosurgical tool to a user ([0197] of Mohr).
*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.
Regarding claim 2, Townley, substantially discloses all the limitations of the claimed invention, specifically, Townley discloses wherein, upon initiating the impedance assessment, the console unit is configured to:
receive, from one or more electrodes of the one or more sets of electrodes, impedance measurement data associated with tissue at the one or more target sites within the selected one of the left and right sides of the sino-nasal cavity ([0089] before the application of a therapeutic neuromodulation energy to determine the presence or location of nerves at the target site); and
process the impedance measurement data to calculate a baseline impedance value for the one or more electrodes in the one or more sets of electrodes ([0089] before the application of a therapeutic neuromodulation energy to determine the presence or location of nerves at the target site to record baseline levels of neural activity which indicates the electrode being in an active/available state to deliver neuromodulation energy).
Regarding claim 3, Townley, substantially discloses all the limitations of the claimed invention, specifically, Townley discloses wherein processing the impedance measurement data comprises calculating aggregate impedance values for* the one or more electrodes of the one or more sets of electrodes within a selected one of the left and right sides of the sino-nasal cavity ([0079]-[0080] impedance values is determined for all electrodes 444 and pair is determined based on impedance changes between the electrodes 444).
*For the purposes of examination, the limitation has been interpreted in the alternative requiring calculating aggregate impedance values for one or more electrodes of the one or more sets of electrodes; or requiring calculating aggregate impedance values across the set of multiple pairs electrodes in a given set of the plurality of electrodes.
Regarding claim 4, Townley, substantially discloses all the limitations of the claimed invention, specifically, Townley discloses wherein the console unit is configured to process impedance measurement data of all pairs of electrodes in a given set within the selected one of the left and right sides of the sino-nasal cavity (FIG. 2, [0046]-[0048] console includes a memory that contains computer readable medium carrying instructions that when executed by the controller, causes the therapeutic assembly to perform certain functions which include to detect the impedance values from the electrodes, including all pairs of electrodes, in order to identify the presence of nerves, locations of nerves, and/or neural activity at the target site. This information then can be communicated to the operator via the display).
Regarding claim 5, Townley, substantially discloses all the limitations of the claimed invention, specifically, Townley discloses wherein the determined availability of the one or more electrodes of the one or more sets of electrodes is 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 6, Townley, substantially discloses all the limitations of the claimed invention, specifically, Townley discloses wherein:
a pair support structures is determined to be available for applying treatment, via one or more electrodes of a respective set of electrodes associated with the pair of support structures determined to be available, to one or more target sites 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
a pair of support structures is determined to be unavailable for applying treatment, via one or more electrodes of a respective set of electrodes associated the pair of support structures determined to be unavailable, to one or more target sites 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 7, Townley, in view of Cadouri, substantially discloses all the limitations of the claimed invention, specifically, Townley discloses the console unit permits repositioning of the pair support structures determined to be unavailable for applying treatment to one or more target sites 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);
providing treatment once successfully repositioned based on a comparison of the calculated baseline impedance value with a predetermined range of baseline impedance values ([0047], [0101], claim 57, the therapeutic assembly is repositioned to a second target site within the nasal region; and energy is then applied, with the therapeutic assembly, to the second target site to therapeutically modulate parasympathetic nerves proximate to the second target site, 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 specifically, Cadouri discloses the console unit is configured to output at least a visual alert, via the interactive interface, indicating to the user the availability treatment device ([0106], [0109] the system is equipped with various audible visual or haptic alarms to alert the operator of conditions relating to the status of the support structures that is displayed on a display screen/interface indicating the status of the likelihood of success or indicating to the user the successful status of the treatment);
wherein the visual alert comprises* at least text displayed on a graphical user interface (GUI) ) ([0076] the appropriate message/text may be displayed on the display include the results and or cessation or modification of treatment protocol indications of impedance measurements and indicate the completion status/state of the treatment [0090] user control can be provided via the user interface) and 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).
*For the purposes of examination, the limitation has been interpreted in the alternative, requiring the visual alert comprises a color displayed on a graphical user interface (GUI), or requiring the visual alert comprises text displayed on a graphical user interface (GUI).
Regarding claim 8, Townley, substantially discloses all the limitations of the claimed invention, specifically, Townley discloses wherein:
the console unit permits transmission of energy from an energy source to one or more electrodes of a respective set of electrodes associated with the pair of support structures determined to be available ([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
the console unit prevents transmission of energy from an energy source to one or more electrodes of a respective set of electrodes associated with the at least one of the pair support structures determined to be unavailable ([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 9, Townley substantially discloses all the limitations of the claimed invention, specifically, Townley discloses wherein the energy comprises radiofrequency (RF) energy from an RF generator (claim 2, radiofrequency (RF) energy is delivered to the target site to therapeutically modulation the postganglionic parasympathetic nerve).
Regarding claim 10 Townley, in view of Cadouri, substantially discloses all the limitations of the claimed invention, specifically, Townley discloses wherein, upon a determination that at least a minimum required number of pairs of electrodes associated with the pair of support structures determined to be available are available (([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, therefore at a minimum, the electrodes in contact with the target tissue are determined to be in an active/available state when this value is compared with the baseline impedance measurement), and specifically, Cadouri discloses the console unit is configured to output at least the visual alert, via the interactive interface, indicating to the user that the treatment device is ready to provide treatment and further permit transmission of energy from an energy source to one or more electrodes ([0048]-[0050] the interface is configured to indicate power levels/availability status visually, by audio, or other means, or may be configured to communicate the information to another device) for subsequent delivery of energy to one or more target sites within the selected one of the left and right sides of the sino-nasal cavity ([0119], FIG. 9, a message is displayed instructing the clinician to attempt to establish better contact and repeat subsequent treatment at the same site).
Regarding claim 11, Townley, in view of Cadouri, substantially discloses all the limitations of the claimed invention, specifically, Cadouri discloses wherein the visual alert comprises* at least text displayed on a graphical user interface (GUI) ([0076] the appropriate message/text may be displayed on the display include the results and or cessation or modification of treatment protocol indications of impedance measurements and indicate the completion status/state of the treatment [0090] user control can be provided via the user interface) indicating the availability of one or more pairs of electrodes ([0048]-[0050] the interface is configured to indicate power levels/availability status visually, by audio, or other means, or may be configured to communicate the information to another device), and specifically, Townley discloses associated with the pair of support structures determined to be available (see FIGS. 4, 5F-5G).
*For the purposes of examination, the limitation has been interpreted in the alternative, requiring the visual alert comprises a color displayed on a graphical user interface (GUI), or requiring the visual alert comprises text displayed on a graphical user interface (GUI).
Regarding claim 12, Townley, in view of Cadouri, substantially discloses all the limitations of the claimed invention, specifically, Cadouri discloses wherein, upon a determination that pairs of electrodes associated with the pair of support structures determined to be unavailable is unavailable ([0086] based on a measurement comparison with a predetermined change (increase or decrease) in impedance of the tissue),
the console unit is configured to output at least the visual alert, via the interactive interface, indicating to the user that the treatment device not ready to provide treatment ([0106], [0109], FIG. 9, the system is equipped with various audible visual or haptic alarms to alert the operator of conditions relating to the status of the support structures that is displayed on a display screen/interface indicating the status of the likelihood of success or indicating to the user the successful status of the treatment) and further prevent transmission of energy from an energy source to one or more electrodes to thereby prevent subsequent delivery of energy to one or more target sites ([0086] the delivery of energy to the electrode may be terminated, thereby terminating delivery of current to the tissue based on one or more predetermined thresholds being reached), and specifically, Townley discloses the electrode being within the selected one of the left and right sides of the sino-nasal cavity (FIGS. 1A-1B, 3A-3E).
Regarding claim 13, Townley, in view of Cadouri, substantially discloses all the limitations of the claimed invention, specifically, Cadouri discloses wherein the visual alert comprises* at least text displayed on a graphical user interface (GUI) indicating the unavailability of the pair of support structures determined to be unavailable ([0076], [0115] the appropriate message/text may be displayed on the display include the results and or cessation or modification of treatment protocol indications of impedance measurements and indicate the completion status/state of the treatment including if the electrode may have moved away from the target site and is unavailable based on the unsuccessful feedback).
*For the purposes of examination, the limitation has been interpreted in the alternative, requiring the visual alert comprises a second color coding displayed on a graphical user interface (GUI), or requiring the visual alert comprises text displayed on a graphical user interface (GUI).
Regarding claim 16, Townley substantially discloses all the limitations of the claimed invention, specifically, Townley discloses wherein electrodes associated with at least one of the plurality of pairs of support structures are configured to deliver energy to the one or more target sites within the selected one of the left and right sides of the sino-nasal cavity of the patient to* disrupt multiple neural signals to thereby reducing production of mucus and/or mucosal engorgement within a nose of the patient and reducing or eliminate one or more symptoms associated with at least one of rhinitis, congestion, and rhinorrhea ([0032], [0038] therapeutic modulation results in the partial or complete incapacitation or other effective disruption of neural activity in the target site thereby severing or modulating the parasympathetic pathways that innervate the mucosa are expected to reduce or eliminate the hyper activation of the submucosal glands and engorgement of vessels that cause symptoms associated with rhinosinusitis and other indications).
*For the purposes of examination, the limitation has been interpreted in the alternative, requiring energy delivery to the one or more target sites within the selected one of the left and right sides of the sino-nasal cavity of the patient to disrupt multiple neural signals; or requiring energy delivery to the one or more target sites within the selected one of the left and right sides of the sino-nasal cavity of the patient to result in local hypoxia of, mucus producing elements; or requiring energy delivery to the one or more target sites within the selected one of the left and right sides of the sino-nasal cavity of the patient to result in local hypoxia of, you coastal engorgement elements, thereby reducing production of mucus and/or mucosal engorgement within a nose of the patient and reducing or eliminate one or more symptoms associated with at least one of rhinitis, congestion, and rhinorrhea.
Regarding claim 17, Townley substantially discloses all the limitations of the claimed invention, specifically, Townley discloses wherein targeted tissue is associated with one or more target sites proximate or inferior to a sphenopalatine foramen (see FIG. 1A, [0033]-[0037]), wherein energy is delivered at a level sufficient to therapeutically modulate postganglionic parasympathetic nerves innervating nasal mucosa at foramina and/or microforamina of a palatine bone of the patient (abstract, the therapeutic element includes an energy delivery element which is configured to therapeutically modulate postganglionic parasympathetic nerves at microforamina of a palatine bone) and causes multiple points of interruption of neural branches extending through foramina and/or microforamina of palatine bone ([0060], FIG. 3A, the treatment site is located proximate to the access point or points of postganglionic parasympathetic nerves (e.g., branches of the posterior nasal nerve and/or other parasympathetic neural fibers that innervate the nasal mucosa) into the nasal cavity, where at these points of the postganglionic parasympathetic nerves is where the energy is delivered to and disrupts the neural transmission of these points).
Regarding claim 18, Townley substantially discloses all of claimed limitations, specifically, Townley discloses wherein targeted tissue is associated with one or more target sites proximate or inferior to a sphenopalatine foramen (see FIG. 1A, [0033]-[0037], where the sphenopalatine vessels travel into the nasal cavity), wherein energy is delivered at a level sufficient to ablate targeted tissue to thereby cause thrombus formation within one or more blood vessels ([0056], [0059] the energy delivered to the target tissue is therapeutically-effective direct cell injury (e.g., necrosis), vascular injury (e.g., starving the cell from nutrients by damaging supplying blood vessels by ligating or coagulating the vasculature, as it is known in the art that energy induced coagulation of the vasculature results in thrombosis formation) associated with mucus producing and/or mucosal engorgement elements within the nose, wherein the resulting local hypoxia of the mucus producing and/or mucosal engorgement elements results in decreased mucosal engorgement to thereby increase volumetric flow through a nasal passage of the patient ([0032], [0038] therapeutic modulation results in the partial or complete incapacitation or other effective disruption of neural activity in the target site thereby severing or modulating the parasympathetic pathways that innervate the mucosa are expected to reduce or eliminate the hyper activation of the submucosal glands and engorgement of vessels that cause symptoms associated with rhinosinusitis and other indications).
Regarding claim 19, Townley, in view of Cadouri, substantially discloses all the limitations of the claimed invention, specifically, Cadouri discloses wherein the predetermined range of baseline impedance values comprises a low baseline impedance value of approximately 100 ohms and a high baseline impedance value of approximately 1 kohms ([0107] low baseline impedance value of being <125 ohms or the high baseline impedance value being >1000 ohms).
Regarding claim 20, Townley, in view of Cadouri, substantially discloses all the limitations of the claimed invention, specifically, Cadouri discloses wherein the predetermined range of baseline impedance values comprises a low baseline impedance value*,** of approximately 400 ohms and a high baseline impedance value*,** of approximately 700 ohms ([0107] low baseline impedance value of being <125 ohms or the high baseline impedance value being >1000 ohms).
*Lacking further criticality or unexpected results, the impedance range used by Cadouri is considered a suitable equivalent to the values of claim 20, as it includes a range of impedance values that encompass those recited in the claim and provides the same end result of ohmically or resistively heat the desired tissue target in the vicinity of the electrode.
**For the purposes of examination, the limitation reciting the baseline impedance values has been interpreted under the broadest reasonable old interpretation to read on a range of values which encompass the claimed values as applicant discloses in [0171] of the published application that the low baseline value may be approximately 100 ohms or a value of 1 kohms, which encompass the values of 400 ohms and 700 ohms, respectively, and does not provide any other disclosure or support that necessitates the exclusion of values below 400 ohms but greater than 100 ohms or values above 700 ohms less than 1 kohms.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.S./Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798