CTFR 18/044,970 CTFR 99347 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 Arguments Applicant’s arguments, filed 02/09/2026, with respect to the objection of claim 26 for minor informalities have been fully considered and are persuasive. The objection of claim 26 for minor informalities has been withdrawn. Applicant’s arguments, filed 02/09/2026, with respect to the rejection of claims 31 and 51 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 31 and 51 under 35 U.S.C. 112(b) has been withdrawn. Applicant’s arguments with respect to independent claims 1, 31, and 51 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. Additionally, since the amendments to independent claims 1, 31, and 51 change the scope of claims 1-7, 10, 25-27, 31-35, 38, and 51-53, and 56-60 and do not merely incorporate limitations from previous dependent claims, a new grounds of rejection is made in view of previously applied references as well as in view of Du et al. (Du, L., Yang, M., Wan, L., Wang, X. H., & Li, S. T. (2016). Electrical stimulation promotes regeneration of injured oculomotor nerves in dogs. Neural regeneration research , 11 (10), 1666–1669. https://doi.org/10.4103/1673-5374.193248) as explained in further detail below. Moreover, Applicant contends that the claims are patentable because none of the cited references mention or consider devices or methods for administration of nerve-regenerative electrical stimulation. Examiner would like to note that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Here, the references as combined in the prior action teach the structural elements of Applicant’s device, where the previously applied references nonetheless teach an endoscopic device capable of performing Applicant’s claimed nerve-regenerative electrical stimulation. This is because the structure of the device will not change based upon the specific treatment being delivered as the strength of the stimulation signal is what is being changed in order to apply regenerative stimulation. Therefore, the combined references are still capable of performing the stimulation as described by Applicant, with new reference Du et al. being added to teach cranial nerve regeneration. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-21-aia AIA Claim s 1-6, 25, 51, and 57-60 are rejected under 35 U.S.C. 103 as being unpatentable over Fox et al. (hereinafter “Fox”) (U.S. Pub. No. 2018/0103994 A1) in view of Du et al. (hereinafter “Du”) (Du, L., Yang, M., Wan, L., Wang, X. H., & Li, S. T. (2016). Electrical stimulation promotes regeneration of injured oculomotor nerves in dogs. Neural regeneration research , 11 (10), 1666–1669. https://doi.org/10.4103/1673-5374.193248) and Azure (U.S. Pub. No. 2009/0076494 A1) . Regarding claim 1, Fox teaches an endoscopic device (Abstract, where “A probe with stimulating electrodes and/or ablation members are provided. The probe may be inserted into a nasal cavity and current may be introduced through the electrodes to stimulate a targeted area. The response to stimulation may be used to identify the targeted nerve,” ¶[0015], where “a visual, audio or haptic feedback may be provided indicating identification of the target nasal nerve”) for providing electrical stimulation (¶[0062], where “a number of stimulating electrodes 104 may be disposed at the distal end of the device 100 and may be placed over a target tissue area. Operation of a system with device 100 with stimulating electrodes 104 to stimulate and identify a target nerve … cannula 102 and electrodes 104 are configured to reach a targeted location within the nasal cavity to effect the desired stimulation and identification of target nerves”), comprising: a distal tool (Figure 3, distal end 116, end effector 106, ¶[0063], where “As can be seen in FIG. 3, system 300 may include device 100 … device 100 may include … an end effector 106”) comprising: an arm (Figure 3, cannula or probe shaft 102, ¶[0063], where “Specifically device 100 may include device handle 110 which may be connected to the cannula 102 and to an end effector 106. Cannula 102 may have a proximal end 114 and a distal end 116 at which end effector is disposed”); one or more electrodes (¶[0063], where “end effector 106 may carry the nerve stimulating electrodes 104 on a surface thereof”) extending from a distal end of the arm (Figure 3, cannula or probe shaft 102, stimulating electrodes 104, end effector 106, where the electrodes are positioned at a distal end of the arm, ¶[0063], where “end effector 106 may carry the nerve stimulating electrodes 104 on a surface thereof”); and a connector at a proximal end of the arm (Figure 10, connector 824, ¶[0072], where “FIG. 8 shows a system 800 with a reusable stimulator tip 818 … Reusable stimulator tip 818 may be releasably coupled from the cannula 802 of probe 810 which may be desirable, for example, to clean the stimulator between human uses … When connected to cannula 802, reusable stimulator tip may extend past the energy probe 806 (which may be … any other type of ablation member as described above with respect to end effector 106 ) … reusable stimulator tip 818, once clicked onto the cannula 802 may connect to the stimulator 304,” ¶[0076], where “reusable stimulator tip 818 may include a connector 824 that snaps onto cannula 802”), wherein the distal tool is configured such that the distal end of the arm is configured to traverse through a nasal cavity to be positioned proximal the cranial nerve such that one or more electrodes are to be positioned proximal to the cranial nerve (Figure 2, where the endoscope is configured to traverse through a nasal cavity to reach target nerves, ¶[0062], where “a number of stimulating electrodes 104 may be disposed at the distal end of the device 100 and may be placed over a target tissue area. Operation of a system with device 100 with stimulating electrodes 104 to stimulate and identify a target nerve … cannula 102 and electrodes 104 are configured to reach a targeted location within the nasal cavity to effect the desired stimulation and identification of target nerves,” ¶[0065], where “if the targeted nerve is a posterior nasal nerve (which may be associated with one or more symptoms of rhinitis, e.g.), then end effector 106 may be positioned in a general region where the posterior nasal nerve is expected.” Examiner interprets that the device is positioned proximal to the cranial nerve since the posterior nasal nerve is a peripheral nerve branch of cranial nerve V.); a handle (Figure 8, handle 810); and an amplifier system (Figure 8, electrical source 304, ¶[0064], where “the electrical source 304 may provide a current through electrodes 104 to stimulate the region, and the response can be observed to determine whether the target nerve has been located.” Examiner interprets that the electrical source is an amplifier system since it operates the electrical stimulation.); wherein the connector of the distal tool connects with the handle such that the one or more electrodes is in conductive connection with the amplifier (¶[0072], where “reusable stimulator tip 818, once clicked onto the cannula 802 may connect to the stimulator 304 via a low profile cable 302 that runs externally but adjacent to the cannula 302 of the device handle 810,” ¶[0076], where “reusable stimulator tip 818 may include a connector 824 that snaps onto cannula 802 ... the proximal end of reusable stimulator tip 818 may include a low-profile cord 826 electrically coupled to the electrodes … configured to be electrically coupled to the electrical source 304.” Examiner takes the position that the connector connects with the handle since the connector connects to the cannula and the cannula acts as an extension of the handle.). Although Fox teaches an endoscopic device for electrical stimulation as well as one or more electrodes, Fox does not explicitly teach that the electrical stimulation is for inducing regeneration of a cranial nerve, wherein the one or more electrodes are insulated within one or more tracks, wherein a portion of each electrode is exposed from the insulated track at a distal end of the distal tool, nor that the electrodes are for nerve-regenerative electrical stimulation. Du teaches electrical stimulation to improve the functional recovery of injured oculomotor nerves as well as the regeneration of injured nerves (Abstract), and further teaches inducing regeneration of a cranial nerve via electrical stimulation and that the electrodes are for nerve-regenerative electrical stimulation (Page 2, Col. 1, ¶ 3, where “Implantable stimulating electrodes that we designed … were encircled proximally and distally around the trunk of the nerve relative to the injured site,” Page 2, Col. 2, ¶ 2, where “In the stimulation group, dogs received direct stimulation with non-continuous, rectangular, 20-ms bipolar current pulses per phase (Powerlab System, AD Instruments Pty Ltd., Castle Hill, Australia) at a frequency of 5 Hz, 1 hour per day for 2 consecutive weeks,” Page 3, Col. 2, ¶ 2, where “Our method of chronically stimulating the oculomotor nerve enhanced its regeneration. After 2 weeks of chronic electrical stimulation, spontaneous MUP amplitudes in the stimulation group showed considerably more improvement than they did in the control group”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Du, which teaches inducing regeneration of a cranial nerve via electrical stimulation and that the electrodes are for nerve-regenerative electrical stimulation, with the invention of Fox in order to functionally recover damaged nerves (Du Page 3, Col. 2, ¶ 2). Although Fox teaches one or more electrodes, neither Fox nor Du teaches one or more electrodes insulated within one or more tracks , wherein a portion of each electrode is exposed from the insulated track at a distal end of the distal tool. Azure teaches an elongate urethral probe having an expandable member with electrode elements at a target location in the patient's urethra, inflating or expanding at the target location, secondary electrodes that are positioned within or adjacent to the prostate tissue and spaced from the electrode elements of the expandable member, and establishing alternating electrical current flow between the electrode elements of the expandable member and the one or more secondary electrodes (Abstract), and further teaches one or more electrodes insulated within one or more tracks (¶[0056], where “probe 80 includes a plurality of electrode elements 82 disposed longitudinally along the surface of an expandable member 84, with each electrode element 82 independently addressed by electrical couples 86 (e.g., conductive cables, insulated wires, or the like) passing along (e.g., embedded in the probe body) or through the probe shaft 88 and out the proximal end. Various electrode patterns and configurations can be included in probe designs according to the present invention, and probes described herein will not be limited to any particular pattern or design.” Examiner takes the position that the electrical couples, which are taught to be insulated wires, are a portion of each electrode element, as the couples are connected to each electrode element, where the insulating portion comprises a track to allow the insulated wires to travel to the electrode elements and out of the proximal end.), wherein a portion of each electrode is exposed from the insulated track at a distal end of the distal tool (Figure 3B, electrode element 82, electrical couples 86, where Examiner takes the position that the electrode elements are inherently exposed from the electrical couples, or insulated track, in order to provide electrical current from the electrode element to the treatment area, as fully insulating the electrodes would prevent the flow of current.). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Azure, which teaches one or more electrodes insulated within one or more tracks, wherein a portion of each electrode is exposed from the insulated track at a distal end of the distal tool, with the modified invention of Fox in order to couple the electrode elements of the expandable member to the proximal end and/or an externally positioned controller and/or power source (Azure ¶[0012]) and since the insulation allows for more precise energy delivery and current establishment at the desired location (Azure ¶[0059]). Regarding claim 2, Fox in combination with Du and Azure teaches all limitations of claim 1 as described in the rejection above. Fox teaches that the distal tool further comprises an inflatable balloon at the distal end of the arm (¶[0037], where “the expandable structure may be a balloon. On the outer surface of the balloon, there may be at least two electrodes that are connected to a source of electricity which can be direct or alternating current,” ¶[0067], where “end effector 106 may expand so as to position electrodes 104 in a desired location”), wherein the distal tool is configured such that the inflatable balloon is configured to traverse through the nasal cavity to be positioned proximal to the olfactory epithelium (Figure 2), and wherein the one or more distal electrodes are disposed on the inflatable balloon (¶[0037], where “On the outer surface of the balloon, there may be at least two electrodes that are connected to a source of electricity which can be direct or alternating current … the more electrodes that are on the surface of the balloon, the more precisely the location of the nerves may be identified,” ¶[0063], where “The end effector 106 may carry the nerve stimulating electrodes 104 on a surface thereof”) and configured to be positioned adjacent to the olfactory epithelium upon inflation of the inflatable balloon when positioned proximal to the olfactory epithelium (Figure 2, ¶[0067], where “end effector 106 may expand so as to position electrodes 104 in a desired location”). Regarding claim 3, Fox in combination with Du and Azure teaches all limitations of claim 1 as described in the rejection above. Although the above-described embodiment of Fox teaches one or more electrodes (¶[0063], where “end effector 106 may carry the nerve stimulating electrodes 104 on a surface thereof”) and that the one or more electrodes are in conductive connection with the amplifier (¶[0076], where “reusable stimulator tip 818 may include a connector 824 that snaps onto cannula 802 ... the proximal end of reusable stimulator tip 818 may include a low-profile cord 826 electrically coupled to the electrodes … configured to be electrically coupled to the electrical source 304”), the above-described embodiment of Fox does not teach that the one or more electrodes is a plurality of electrodes arranged in an array, nor that each electrode of the array having its own insulated track such that each electrode is individually in conductive connection with the amplifier system. A second embodiment of Fox teaches that the one or more electrodes is a plurality of electrodes arranged in an array (Figure 7, electrodes 704A-D, ¶[0071], where “As can be seen in FIG. 7, end effector 706 may include four electrodes 704A-D as opposed to two electrodes”), and that each electrode of the array is individually in conductive connection with the amplifier system (¶[0071], where “all four electrodes 704A-D may be coupled to electrical source 304 so that current may be directed through any or all of the electrodes 704A-D”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Fox, which teaches the one or more electrodes is a plurality of electrodes arranged in an array and that each electrode of the array is individually in conductive connection with the amplifier system, with the modified invention of Fox in order to allow a user to selectively stimulate certain areas in contact with end effector to more precisely stimulate and identify/locate a target nerve (Fox ¶[0071]). Neither embodiment of Fox teaches each electrode of the array having its own insulated track. Azure teaches each electrode of the array having its own insulated track (¶[0056], where “probe 80 includes a plurality of electrode elements 82 disposed longitudinally along the surface of an expandable member 84, with each electrode element 82 independently addressed by electrical couples 86 (e.g., conductive cables, insulated wires, or the like) passing along (e.g., embedded in the probe body) or through the probe shaft 88 and out the proximal end. Various electrode patterns and configurations can be included in probe designs according to the present invention, and probes described herein will not be limited to any particular pattern or design.” Examiner takes the position that the electrical couples, which are taught to be insulated wires, are a portion of each electrode element, as the couples are connected to each electrode element, where the insulating portion comprises a track to allow the insulated wires to travel to the electrode elements and out of the proximal end.). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Azure, which teaches each electrode of the array having its own insulated track, with the modified invention of Fox in order to couple the electrode elements of the expandable member to the proximal end and/or an externally positioned controller and/or power source (Azure ¶[0012]) and since the insulation allows for more precise energy delivery and current establishment at the desired location (Azure ¶[0059]). Regarding claim 4, Fox as modified in combination with Du and Azure teaches all limitations of claim 3 as described in the rejection above. The second embodiment of Fox teaches that each electrode of the array is individually operable via the amplifier system (¶[0071], where “all four electrodes 704A-D may be coupled to electrical source 304 so that current may be directed through any or all of the electrodes 704A-D. The current will pass through the tissue between whichever electrodes are activated and stimulate any intervening nerves.” Examiner interprets that since any or all of the electrodes can have current directed through them that each electrode can be individually operable.). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Fox, which teaches that each electrode of the array is individually operable via the amplifier system, with the modified invention of Fox in order to allow a user to selectively stimulate certain areas in contact with end effector to more precisely stimulate and identify/locate a target nerve (Fox ¶[0071]). Regarding claim 5, Fox as modified in combination with Du and Azure teaches all limitations of claim 3 as described in the rejection above. Azure teaches that each electrode has a terminus that is exposed (Figure 3B, electrode elements 82, electrical couples 86, where the terminus of each electrode element is inherently exposed from the electrical couples, or insulated track, in order to provide electrical current from the electrode element to the treatment area, as fully insulating the electrodes would prevent the flow of current.). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Azure, which teaches each electrode has a terminus that is exposed, with the modified invention of Fox in order to couple the electrode elements of the expandable member to the proximal end and/or an externally positioned controller and/or power source (Azure ¶[0012]) and since the insulation allows for more precise energy delivery and current establishment at the desired location (Azure ¶[0059]). Regarding claim 6, Fox as modified in combination with Du and Azure teaches all limitations of claim 5 as described in the rejection above. Azure teaches that each electrode terminus is positioned in such a way to prevent electrical interference with another electrode terminus (Figure 3B, electrode element 82, where each electrode terminus is positioned to be spaced apart from a neighboring electrode terminus. Examiner takes the position that since the electrode elements are shown to be spaced apart from one another that this allows for the prevention of electrical interference with another electrode terminus, where prevention of electrical interference is a functional result of positioning each electrode terminus apart from one another.). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Azure, which teaches that each electrode terminus is positioned in such a way to prevent electrical interference with another electrode terminus, with the modified invention of Fox in order to position or bring the conductive electrode elements in improved or better contact with the target location (Azure ¶[0014]). Regarding claim 25, Fox in combination with Du and Azure teaches all limitations of claim 1 as described in the rejection above. Fox teaches that the distal tool is detachable (¶[0072], where “Reusable stimulator tip 818 may be releasably coupled from the cannula 802 of probe 810 which may be desirable, for example, to clean the stimulator between human uses … reusable stimulator tip 818 may be clicked onto the distal end 816 of the cannula 802 when in use, and may be pulled off when not in use”). Regarding claim 51, Fox teaches a method of performing electrical stimulation via a nasal cavity (Abstract, where “methods for identifying and/or ablating targeted nerves are provided. A probe with stimulating electrodes and/or ablation members are provided. The probe may be inserted into a nasal cavity and current may be introduced through the electrodes to stimulate a targeted area. The response to stimulation may be used to identify the targeted nerve”), utilizing a distal tool (Figure 3, distal end 116, end effector 106, ¶[0063], where “As can be seen in FIG. 3, system 300 may include device 100 … device 100 may include … an end effector 106”) with an inflatable balloon (¶[0037], where “the expandable structure may be a balloon. On the outer surface of the balloon, there may be at least two electrodes that are connected to a source of electricity which can be direct or alternating current,” ¶[0067], where “end effector 106 may expand so as to position electrodes 104 in a desired location”), comprising: providing an endoscopic device (Abstract, where “A probe with stimulating electrodes and/or ablation members are provided. The probe may be inserted into a nasal cavity and current may be introduced through the electrodes to stimulate a targeted area. The response to stimulation may be used to identify the targeted nerve,” ¶[0015], where “a visual, audio or haptic feedback may be provided indicating identification of the target nasal nerve”) comprising: the distal tool (Figure 3, distal end 116, end effector 106, ¶[0063], where “As can be seen in FIG. 3, system 300 may include device 100 … device 100 may include … an end effector 106”) comprising: an arm (Figure 3, cannula or probe shaft 102, ¶[0063], where “Specifically device 100 may include device handle 110 which may be connected to the cannula 102 and to an end effector 106. Cannula 102 may have a proximal end 114 and a distal end 116 at which end effector is disposed”), wherein the inflatable balloon extends from a distal end of the arm (¶[0072], where “energy probe 806 (which may be … any other type of ablation member as described above with respect to end effector 106),” Figure 9C, end effector 806, lever spring arm 822, which shows how the end effector contacts the lever spring arm, Figure 10, lever spring arm 822, connector 824. Examiner interprets that the end effector 806, or inflatable balloon, extends from the distal end of the arm since the lever spring arm 822 extends along the end effector 806 and end effector 806 extends from a length of the lever spring arm 822 and consequently extends from a distal end as well.); a connector at a proximal end of the arm (Figure 10, connector 824, lever spring arm 822, where the connector is on the proximal end of the arm, ¶[0072], where “FIG. 8 shows a system 800 with a reusable stimulator tip 818 … Reusable stimulator tip 818 may be releasably coupled from the cannula 802 of probe 810 which may be desirable, for example, to clean the stimulator between human uses … When connected to cannula 802, reusable stimulator tip may extend past the energy probe 806 (which may be … any other type of ablation member as described above with respect to end effector 106 ) … reusable stimulator tip 818, once clicked onto the cannula 802 may connect to the stimulator 304,” ¶[0076], where “reusable stimulator tip 818 may include a connector 824 that snaps onto cannula 802”); and one or more electrodes disposed on the inflatable balloon (¶[0037], where “On the outer surface of the balloon, there may be at least two electrodes that are connected to a source of electricity which can be direct or alternating current … the more electrodes that are on the surface of the balloon, the more precisely the location of the nerves may be identified,” ¶[0063], where “The end effector 106 may carry the nerve stimulating electrodes 104 on a surface thereof”); a handle (Figure 8, handle 810); and an amplifier system (Figure 8, electrical source 304, ¶[0064], where “the electrical source 304 may provide a current through electrodes 104 to stimulate the region, and the response can be observed to determine whether the target nerve has been located.” Examiner interprets that the electrical source is an amplifier system since it operates the electrical stimulation.); wherein the connector connects with the handle such that the one or more electrodes is in conductive connection with the amplifier (¶[0072], where “reusable stimulator tip 818, once clicked onto the cannula 802 may connect to the stimulator 304 via a low profile cable 302 that runs externally but adjacent to the cannula 302 of the device handle 810,” ¶[0076], where “reusable stimulator tip 818 may include a connector 824 that snaps onto cannula 802 ... the proximal end of reusable stimulator tip 818 may include a low-profile cord 826 electrically coupled to the electrodes … configured to be electrically coupled to the electrical source 304.” Examiner takes the position that the connector connects with the handle since the connector connects to the cannula and the cannula acts as an extension of the handle.); advancing the inflatable balloon in a deflated state through the nasal cavity to be positioned proximal to the cranial nerve; inflating the balloon when the balloon is positioned proximal to the cranial nerve, wherein inflating the balloon positions the one or more electrodes to be adjacent to the cranial nerve (Figure 2, where the endoscope is configured to traverse through a nasal cavity to reach target nerves, ¶[0062], where “a number of stimulating electrodes 104 may be disposed at the distal end of the device 100 and may be placed over a target tissue area. Operation of a system with device 100 with stimulating electrodes 104 to stimulate and identify a target nerve … cannula 102 and electrodes 104 are configured to reach a targeted location within the nasal cavity to effect the desired stimulation and identification of target nerves,” ¶[0065], where “if the targeted nerve is a posterior nasal nerve (which may be associated with one or more symptoms of rhinitis, e.g.), then end effector 106 may be positioned in a general region where the posterior nasal nerve is expected,” ¶[0083], where “a distal end of a probe device such as device 100 may be inserted into a nasal cavity and positioned so that electrodes 104 are disposed adjacent to a region where a target nerve is expected to be located ... the positioning may further include expanding an end effector such as end effector 106 to place the electrodes in closer contact to the desired region .” Examiner takes the position that since the end effector is inserted through the nasal cavity then positioned, where positioning the end effector includes expanding the end effector, that this means the end effector is initially in a deflated state and is inflated once placed within the nasal cavity. Furthermore, Examiner interprets that the device is positioned proximal to the cranial nerve since the posterior nasal nerve is a peripheral nerve branch of cranial nerve V.); and administering electrical stimulation to the nerve using the one or more electrodes (¶[0064], where “the end effector 106 may be placed over the region that the nerve(s) may be located, the electrical source 304 may provide a current through electrodes 104 to stimulate the region, and the response can be observed to determine whether the target nerve has been located”). Although Fox teaches method of performing electrical stimulation as well as one or more electrodes, Fox does not explicitly teach performing nerve-regenerating electrical stimulation to upon a cranial nerve accessed, a flexible arm, one or more electrodes insulated within one or more tracks, wherein a portion of each electrode is exposed from the insulated track at the inflatable balloon, nor administering nerve-regenerative electrical stimulation to the cranial nerve. Du teaches performing nerve-regenerating electrical stimulation to upon a cranial nerve accessed and administering nerve-regenerative electrical stimulation to the cranial nerve (Page 2, Col. 1, ¶ 3, where “Implantable stimulating electrodes that we designed … were encircled proximally and distally around the trunk of the nerve relative to the injured site,” Page 2, Col. 2, ¶ 2, where “In the stimulation group, dogs received direct stimulation with non-continuous, rectangular, 20-ms bipolar current pulses per phase (Powerlab System, AD Instruments Pty Ltd., Castle Hill, Australia) at a frequency of 5 Hz, 1 hour per day for 2 consecutive weeks,” Page 3, Col. 2, ¶ 2, where “Our method of chronically stimulating the oculomotor nerve enhanced its regeneration. After 2 weeks of chronic electrical stimulation, spontaneous MUP amplitudes in the stimulation group showed considerably more improvement than they did in the control group”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Du, which teaches performing nerve-regenerating electrical stimulation to upon a cranial nerve accessed and administering nerve-regenerative electrical stimulation to the cranial nerve, with the invention of Fox in order to functionally recover damaged nerves (Du Page 3, Col. 2, ¶ 2). Neither Fox nor Du teaches a flexible arm nor one or more electrodes insulated within one or more tracks, wherein a portion of each electrode is exposed from the insulated track at the inflatable balloon. Azure teaches a flexible arm (¶[0063], where “probe 190 includes a flexible elongate body 198 having a proximal portion and a distal portion. The distal portion includes an expandable member 192, similar to embodiments described elsewhere herein in having an expandable member, such as a balloon, with electrode elements 194, 196 disposed thereon”), one or more electrodes insulated within one or more tracks (¶[0056], where “probe 80 includes a plurality of electrode elements 82 disposed longitudinally along the surface of an expandable member 84, with each electrode element 82 independently addressed by electrical couples 86 (e.g., conductive cables, insulated wires, or the like) passing along (e.g., embedded in the probe body) or through the probe shaft 88 and out the proximal end. Various electrode patterns and configurations can be included in probe designs according to the present invention, and probes described herein will not be limited to any particular pattern or design.” Examiner takes the position that the electrical couples, which are taught to be insulated wires, are a portion of each electrode element, as the couples are connected to each electrode element, where the insulating portion comprises a track to allow the insulated wires to travel to the electrode elements and out of the proximal end.), wherein a portion of each electrode is exposed from the insulated track at the inflatable balloon (Figure 3B, electrode element 82, expandable member 84, electrical couples 86, where Examiner takes the position that the electrode elements on the expandable member are inherently exposed from the electrical couples, or the insulated track, in order to provide electrical current from the electrode element to the treatment area, as fully insulating the electrodes would prevent the flow of current.). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Azure, which teaches a flexible arm, nor one or more electrodes insulated within one or more tracks, wherein a portion of each electrode is exposed from the insulated track at the inflatable balloon, with the modified invention of Fox in order to allow for guidance to the treatment area (Azure ¶[0038]), to couple the electrode elements of the expandable member to the proximal end and/or an externally positioned controller and/or power source (Azure ¶[0012]), and since the insulation allows for more precise energy delivery and current establishment at the desired location (Azure ¶[0059]). Regarding claim 57, Fox in combination with Du and Azure teaches all limitations of claim 51 as described in the rejection above. Furthermore, regarding claim 57, see the rejection of claim 3 above. Regarding claim 58, Fox as modified in combination with Du and Azure teaches all limitations of claim 57 as described in the rejection above. The second embodiment of Fox teaches that a subset of the plurality of electrodes is utilized for the performing of the recording electrical signal or the administering electrical stimulation (Figure 7, electrodes 704A-D, ¶[0071], where “As can be seen in FIG. 7, end effector 706 may include four electrodes 704A-D as opposed to two electrodes … all four electrodes 704A-D may be coupled to electrical source 304 so that current may be directed through any or all of the electrodes 704A-D. The current will pass through the tissue between whichever electrodes are activated and stimulate any intervening nerves as described above.” Examiner takes the position that since any or all of the electrodes of the plurality of electrodes can have current directed through them that a subset of the plurality of electrodes is utilized for administering electrical stimulation as any one or more of the four electrodes can have current pass through it, creating a subset.). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Fox, which teaches that a subset of the plurality of electrodes is utilized for the performing of the recording electrical signal or the administering electrical stimulation, with the modified invention of Fox in order to allow a user to selectively stimulate certain areas in contact with end effector to more precisely stimulate and identify/locate a target nerve (Fox ¶[0071]). Regarding claim 59, Fox as modified in combination with Du and Azure teaches all limitations of claim 57 as described in the rejection above. The second embodiment of Fox teaches that the entire array of electrodes is utilized for the performing of the recording electrical signal or the administering electrical stimulation (Figure 7, electrodes 704A-D, ¶[0071], where “As can be seen in FIG. 7, end effector 706 may include four electrodes 704A-D as opposed to two electrodes … all four electrodes 704A-D may be coupled to electrical source 304 so that current may be directed through any or all of the electrodes 704A-D. The current will pass through the tissue between whichever electrodes are activated and stimulate any intervening nerves as described above.” Examiner takes the position that since any or all of the electrodes of the plurality of electrodes can have current directed through them that the entire array of electrodes is utilized to administer electrical stimulation.). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Fox, which teaches that the entire array of electrodes is utilized for the performing of the recording electrical signal or the administering electrical stimulation, with the modified invention of Fox in order to allow a user to selectively stimulate certain areas in contact with end effector to more precisely stimulate and identify/locate a target nerve (Fox ¶[0071]). Regarding claim 60, Fox in combination with Du and Azure teaches all limitations of claim 51 as described in the rejection above. Fox teaches that a visualization aid is utilized for the positioning of the one or more electrodes (¶[0015], where “a visual, audio or haptic feedback may be provided indicating identification of the target nasal nerve”) . 07-22-aia AIA Claim s 7 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Fox, Du, and Azure as applied to claim 2 above, and further in view of Townley et al. (hereinafter “Townley”) (U.S. Pub. No. 2016/0331459 A1) . Regarding claim 7, Fox in combination with Du and Azure teaches all limitations of claim 2 as described in the rejection above. Although Fox teaches insertion of a balloon through the nasal cavity to treat a target area, such as a target nerve or the nasal mucosa (¶[0061], where “device 100 may include a hand piece 110 and cannula or probe shaft 102 which is shown after it is inserted in the nasal cavity 160 of a subject's nose 150,” ¶[0062], where “Operation of a system with device 100 with stimulating electrodes 104 to stimulate and identify a target nerve … For example, cannula 102 and electrodes 104 may be configured to reach a region of the nasal mucosa covering a medial pterygoid plate of sphenoid bone through a passage of a middle nasal meatus”), none of Fox, Du, nor Azure specifies that the treatment area is an olfactory epithelium or a sinus cavity. Townley teaches devices for therapeutic nasal neuromodulation including a shaft and a therapeutic element at a distal portion of the shaft, where the therapeutic element can be configured to therapeutically modulate nerves that innervate the frontal, ethmoidal, sphenoidal, and maxillary sinuses for the treatment of chronic sinusitis (Abstract), and further teaches that the balloon (¶[0116], where “the therapeutic assembly 1312 includes a balloon 1370 that carries the electrodes 1344”) is sized for the olfactory epithelium (¶[0118], where “balloon 1370 can have an ovoid shape when in the expanded state, which is expected to improve the conformance to anatomical variations at the target site within the nasal cavity. In other embodiments, the balloon 1370 can have a circular shape, a spherical shape, an irregular shape, and/or other suitable shape for expansion within the nasal anatomy,” ¶[0140], where “Any of the therapeutic modulation devices and system described above can be used to therapeutically modulate nerves that innervate the para-nasal sinuses to treat chronic sinusitis and/or similar indications ... para-nasal sinuses include the frontal sinuses FS, the sphenoidal sinuses SS, the maxillary sinuses (“MS”; not shown), and the ethmoidal sinuses or ethmoidal cells (not shown), which include the posterior ethmoidal cells (“PEC”), the middle ethmoidal cells (“MEC”), and the anterior ethmoidal cells (“AEC”). Each sinus opens to the nasal cavity at one or more discrete ostia.” Examiner interprets that since the olfactory epithelium is within the nasal cavity, and within the portion being treated, that the balloon is sized for the olfactory epithelium). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Townley, which teaches that the balloon is sized for the olfactory epithelium, with the modified invention of Fox in order to improve the conformance to anatomical variations at the target site within the nasal cavity (Townley ¶[0118]). Regarding claim 10, Fox in combination with Du and Azure teaches all limitations of claim 2 as described in the rejection above. None of Fox, Du, nor Azure teaches that the arm is flexible and steerable. Townley teaches that the arm is flexible and steerable (¶[0051], where “the shaft 208 can be a steerable device (e.g., a steerable catheter) with a small bend radius (e.g., a 5 mm bend radius, a 4 mm bend radius, a 3 mm bend radius or less) that allows the clinician to navigate through the tortuous nasal anatomy. The steerable shaft can further be configured to articulate in at least two different directions”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Townley, which teaches that the arm is flexible and steerable, with the modified invention of Fox in order to allow the clinician to navigate through the tortuous nasal anatomy (Townley ¶[0051]) . 07-22-aia AIA Claim s 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Fox, Du, and Azure as applied to claim 1 above, and further in view of Chang et al. (hereinafter “Chang”) (U.S. Pub. No. 2006/0095066 A1) . Regarding claim 26, Fox in combination with Du and Azure teaches all limitations of claim 1 as described in the rejection above. Fox teaches a distal tool (Figure 3, distal end 116, end effector 106, ¶[0063], where “As can be seen in FIG. 3, system 300 may include device 100 … device 100 may include … an end effector 106”) comprising a connector (Figure 10, connector 824, ¶[0072], where “FIG. 8 shows a system 800 with a reusable stimulator tip 818 … Reusable stimulator tip 818 may be releasably coupled from the cannula 802 of probe 810 which may be desirable, for example, to clean the stimulator between human uses … When connected to cannula 802, reusable stimulator tip may extend past the energy probe 806 (which may be … any other type of ablation member as described above with respect to end effector 106) … reusable stimulator tip 818, once clicked onto the cannula 802 may connect to the stimulator 304,” ¶[0076], where “reusable stimulator tip 818 may include a connector 824 that snaps onto cannula 802”). Azure teaches one or more electrodes insulated within one or more tracks (¶[0056], where “probe 80 includes a plurality of electrode elements 82 disposed longitudinally along the surface of an expandable member 84, with each electrode element 82 independently addressed by electrical couples 86 (e.g., conductive cables, insulated wires, or the like) passing along (e.g., embedded in the probe body) or through the probe shaft 88 and out the proximal end. Various electrode patterns and configurations can be included in probe designs according to the present invention, and probes described herein will not be limited to any particular pattern or design.” Examiner takes the position that the electrical couples, which are taught to be insulated wires, are a portion of each electrode element, as the couples are connected to each electrode element, where the insulating portion comprises a track to allow the insulated wires to travel to the electrode elements and out of the proximal end.), wherein a portion of each electrode is exposed from the insulated track at the distal end of the distal tool (Figure 3B, electrode element 82, electrical couples 86, where Examiner takes the position that the electrode elements are inherently exposed from the electrical couples, or insulated track, in order to provide electrical current from the electrode element to the treatment area, as fully insulating the electrodes would prevent the flow of current.). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Azure, which teaches one or more electrodes insulated within one or more tracks, wherein a portion of each electrode is exposed from the insulated track at the distal end of the distal tool, with the modified invention of Fox in order to couple the electrode elements of the expandable member to the proximal end and/or an externally positioned controller and/or power source (Azure ¶[0012]) and since the insulation allows for more precise energy delivery and current establishment at the desired location (Azure ¶[0059]). Although Fox teaches a detachable distal tool (¶[0072], where “Reusable stimulator tip 818 may be releasably coupled from the cannula 802 of probe 810 which may be desirable, for example, to clean the stimulator between human uses … reusable stimulator tip 818 may be clicked onto the distal end 816 of the cannula 802 when in use, and may be pulled off when not in use”), none of Fox, Du, nor Azure explicitly teach a set of two or more interchangeable distal tools. Chang teaches devices for diagnosing and/or treating sinusitis or other conditions of the paranasal sinuses (¶[0010]), and further teaches a set of two or more interchangeable distal tools (¶[0145], where “a guide catheter compris[es] a common proximal portion and a plurality of detachable distal tips. Distal end of common proximal portion 760 attaches to proximal end of a first detachable tip 762 by an attachment mechanism … distal end of common proximal portion 760 attaches to proximal end of a second detachable tip 764 by an attachment mechanism”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Chang, which teaches a set of two or more interchangeable distal tools, with the modified invention of Fox in order to allow the device to be used in a variety of diagnostic or therapeutic devices and to allow easy access to one or more anatomical regions in the nose by using multiple detachable distal tips, wherein each detachable tip is optimized for access to a particular anatomical region (Chang ¶[0145]). Regarding claim 27, Fox in combination with Du, Azure, and Chang teaches all limitations of claim 26 as described in the rejection above. Fox teaches a distal tool (Figure 3, distal end 116, end effector 106, ¶[0063], where “As can be seen in FIG. 3, system 300 may include device 100 … device 100 may include … an end effector 106”) comprising: an inflatable balloon at the distal end of the arm (¶[0037], where “the expandable structure may be a balloon. On the outer surface of the balloon, there may be at least two electrodes that are connected to a source of electricity which can be direct or alternating current,” ¶[0067], where “end effector 106 may expand so as to position electrodes 104 in a desired location”), wherein the distal tool is configured such that the inflatable balloon is configured to traverse through the nasal cavity to be positioned proximal to the olfactory epithelium (Figure 2), and wherein the one or more distal electrodes are disposed on the inflatable balloon (¶[0037], where “On the outer surface of the balloon, there may be at least two electrodes that are connected to a source of electricity which can be direct or alternating current … the more electrodes that are on the surface of the balloon, the more precisely the location of the nerves may be identified,” ¶[0063], where “The end effector 106 may carry the nerve stimulating electrodes 104 on a surface thereof”) and configured to be positioned adjacent to the olfactory epithelium upon inflation of the inflatable balloon when positioned proximal to the olfactory epithelium (Figure 2, ¶[0067], where “end effector 106 may expand so as to position electrodes 104 in a desired location”), and that the distal tool comprises one of the following: a first flat surface at the distal end of the arm, wherein the distal tool is configured such that the first flat surface is configured to traverse through the nasal cavity to be positioned proximal to the olfactory epithelium, and wherein the one or more distal electrodes are disposed on the first flat surface and configured to be positioned adjacent to the olfactory epithelium upon positioning the first flat surface proximal to the olfactory epithelium (Examiner notes that since the embodiment including a first flat surface was withdrawn from consideration, that this option is also withdrawn from consideration as a second distal tool.). Chang teaches that the set of two or more interchangeable distal tools includes a first distal tool (¶[0145], where “Distal end of common proximal portion 760 attaches to proximal end of a first detachable tip 762 by an attachment mechanism”) and second distal tool (¶[0145], where “a guide catheter compris[es] a common proximal portion and a plurality of detachable distal tips. … distal end of common proximal portion 760 attaches to proximal end of a second detachable tip 764 by an attachment mechanism”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Chang, which teaches that the set of two or more interchangeable distal tools includes a first distal tool and second distal tool, with the modified invention of Fox in order to allow the device to be used in a variety of diagnostic or therapeutic devices and to allow easy access to one or more anatomical regions in the nose by using multiple detachable distal tips, wherein each detachable tip is optimized for access to a particular anatomical region (Chang ¶[0145]) . 07-21-aia AIA Claim s 31-34 and are rejected under 35 U.S.C. 103 as being unpatentable over Fox in view of Shantha (U.S. Pub. No. 2012/0323214 A1), Du, and Azure . Regarding claim 31, Fox teaches a tool for providing electrical stimulation (Abstract, where “A probe with stimulating electrodes and/or ablation members are provided. The probe may be inserted into a nasal cavity and current may be introduced through the electrodes to stimulate a targeted area. The response to stimulation may be used to identify the targeted nerve,” ¶[0062], where “a number of stimulating electrodes 104 may be disposed at the distal end of the device 100 and may be placed over a target tissue area. Operation of a system with device 100 with stimulating electrodes 104 to stimulate and identify a target nerve … cannula 102 and electrodes 104 are configured to reach a targeted location within the nasal cavity to effect the desired stimulation and identification of target nerves”), comprising: an inflatable balloon (¶[0037], where “the expandable structure may be a balloon. On the outer surface of the balloon, there may be at least two electrodes that are connected to a source of electricity which can be direct or alternating current,” ¶[0067], where “end effector 106 may expand so as to position electrodes 104 in a desired location”) extending from an arm at a distal end (Figure 9C, end effector 806, lever spring arm 822, which shows how the end effector contacts the lever spring arm, Figure 10, lever spring arm 822, connector 824. Examiner interprets that the lever spring arm 822 extends from the end effector 806, or inflatable balloon, to the connector 824 since the lever spring arm 822 extends along the end effector 806, which is type of extension from the end effector 806, to contact the connector 824.); a connector at a proximal end of the arm (Figure 10, connector 824, lever spring arm 822, where the connector is on the proximal end of the arm, ¶[0072], where “FIG. 8 shows a system 800 with a reusable stimulator tip 818 … Reusable stimulator tip 818 may be releasably coupled from the cannula 802 of probe 810 which may be desirable, for example, to clean the stimulator between human uses … When connected to cannula 802, reusable stimulator tip may extend past the energy probe 806 (which may be … any other type of ablation member as described above with respect to end effector 106 ) … reusable stimulator tip 818, once clicked onto the cannula 802 may connect to the stimulator 304,” ¶[0076], where “reusable stimulator tip 818 may include a connector 824 that snaps onto cannula 802”); and one or more electrodes disposed on the inflatable balloon (¶[0037], where “On the outer surface of the balloon, there may be at least two electrodes that are connected to a source of electricity which can be direct or alternating current … the more electrodes that are on the surface of the balloon, the more precisely the location of the nerves may be identified,” ¶[0063], where “The end effector 106 may carry the nerve stimulating electrodes 104 on a surface thereof”), and wherein each electrode is capable of being in conductive connection with an amplifier system via the connector (¶[0072], where “reusable stimulator tip 818, once clicked onto the cannula 802 may connect to the stimulator 304 via a low profile cable 302 that runs externally but adjacent to the cannula 302 of the device handle 810,” ¶[0076], where “reusable stimulator tip 818 may include a connector 824 that snaps onto cannula 802 ... the proximal end of reusable stimulator tip 818 may include a low-profile cord 826 electrically coupled to the electrodes … configured to be electrically coupled to the electrical source 304.” Examiner interprets that the electrical source is an amplifier system since it operates the electrical stimulation.); wherein the tool is configured such that the inflatable balloon is configured to traverse through the nasal cavity to be positioned proximal to the olfactory epithelium (Figure 2), wherein the one or more distal electrodes are configured to be positioned adjacent to the olfactory epithelium upon inflation of the inflatable balloon when positioned proximal to the olfactory epithelium (Figure 2, ¶[0067], where “end effector 106 may expand so as to position electrodes 104 in a desired location”). Although Fox teaches an endoscopic device for electrical stimulation as well as one or more electrodes, Fox does not explicitly teach that the electrical stimulation is for inducing olfactory nerve regeneration, a flexible arm, wherein each electrode is insulated within a track but has an exposed portion on the inflatable balloon, wherein each insulated track runs along the flexible arm from the inflatable balloon to the connector, nor that the electrodes are for nerve-regenerative electrical stimulation. Shantha teaches an inflatable balloon with stimulating leads on its surface that is inserted into the nose (¶[0178], where “balloon 527 part has the insertion body which is inserted through the nose through the sphenoid foramina and then into the hollow sphenoid sinus with the aid of a fiber optic nasal scope … The balloon 527 is provided with multiple electrical leads on the exterior of the balloon as shown on the balloon. These electrical leads are connected by electrical connectors to an electrical output manipulator 517. Electrical stimulus (electrical impulses) provided through the electrical leads to stimulate”), and further teaches treatment of an olfactory nerve (¶[0184], where “the inventive device placed on the olfactory nerve embedded olfactory mucosa to stimulate the olfactory mucosa”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Shantha, which teaches treatment of an olfactory nerve, with the modified invention of Fox in order to stimulate the olfactory mucosa (Shantha ¶[0184]). Although Fox teaches an endoscopic device for electrical stimulation as well as one or more electrodes, neither Fox nor Shantha explicitly teaches that the electrical stimulation is for inducing nerve regeneration, a flexible arm, wherein each electrode is insulated within a track but has an exposed portion on the inflatable balloon, wherein each insulated track runs along the flexible arm from the inflatable balloon to the connector, nor that the electrodes are for nerve-regenerative electrical stimulation. Du teaches inducing nerve regeneration via electrical stimulation and electrodes for nerve-regenerative electrical stimulation (Page 2, Col. 1, ¶ 3, where “Implantable stimulating electrodes that we designed … were encircled proximally and distally around the trunk of the nerve relative to the injured site,” Page 2, Col. 2, ¶ 2, where “In the stimulation group, dogs received direct stimulation with non-continuous, rectangular, 20-ms bipolar current pulses per phase (Powerlab System, AD Instruments Pty Ltd., Castle Hill, Australia) at a frequency of 5 Hz, 1 hour per day for 2 consecutive weeks,” Page 3, Col. 2, ¶ 2, where “Our method of chronically stimulating the oculomotor nerve enhanced its regeneration. After 2 weeks of chronic electrical stimulation, spontaneous MUP amplitudes in the stimulation group showed considerably more improvement than they did in the control group”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Du, which teaches inducing nerve regeneration via electrical stimulation and electrodes for nerve-regenerative electrical stimulation, with the modified invention of Fox in order to functionally recover damaged nerves (Du Page 3, Col. 2, ¶ 2). None of Fox, Shantha, nor Du teaches a flexible arm, that each electrode is insulated within a track but has an exposed portion on the inflatable balloon, nor that each insulated track runs along the flexible arm from the inflatable balloon to the connector. Azure teaches a flexible arm (¶[0063], where “probe 190 includes a flexible elongate body 198 having a proximal portion and a distal portion. The distal portion includes an expandable member 192, similar to embodiments described elsewhere herein in having an expandable member, such as a balloon, with electrode elements 194, 196 disposed thereon”), that each electrode is insulated within a track (¶[0056], where “probe 80 includes a plurality of electrode elements 82 disposed longitudinally along the surface of an expandable member 84, with each electrode element 82 independently addressed by electrical couples 86 (e.g., conductive cables, insulated wires, or the like) passing along (e.g., embedded in the probe body) or through the probe shaft 88 and out the proximal end. Various electrode patterns and configurations can be included in probe designs according to the present invention, and probes described herein will not be limited to any particular pattern or design.” Examiner takes the position that the electrical couples, which are taught to be insulated wires, are a portion of each electrode element, as the couples are connected to each electrode element, where the insulating portion comprises a track to allow the insulated wires to travel to the electrode elements and out of the proximal end.) but has an exposed portion on the inflatable balloon (Figure 3B, electrode element 82, expandable member 84, electrical couples 86, where Examiner takes the position that the electrode elements on the expandable member are inherently exposed from the electrical couples, or insulated track, in order to provide electrical current from the electrode element to the treatment area, as fully insulating the electrodes would prevent the flow of current.), and that each insulated track runs along the flexible arm from the inflatable balloon to a connector (Figure 3B, electrode element 82, expandable member 84, electrical couples 86, where the electrical couples, or insulated track, run along the flexible arm from the inflatable balloon to a proximal end of the probe 80. Examiner takes the position that since Azure teaches the insulated tracks running along the flexible arm from the inflatable balloon to a proximal and, and that since Fox teaches a connector on the proximal end of the arm, that this teaches that the insulated tracks run from the inflatable balloon to the connector.). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Azure, which teaches a flexible arm, that each electrode is insulated within a track but has an exposed portion on the inflatable balloon, and that each insulated track runs along the flexible arm from the inflatable balloon to the connector, with the modified invention of Fox in order to allow for guidance to the treatment area (Azure ¶[0038]), to couple the electrode elements of the expandable member to the proximal end and/or an externally positioned controller and/or power source (Azure ¶[0012]), and since the insulation allows for more precise energy delivery and current establishment at the desired location (Azure ¶[0059]). Regarding claim 32, Fox in combination with Shantha, Du, and Azure teaches all limitations of claim 31 as described in the rejection above. Although the above-described embodiment of Fox teaches one or more electrodes (¶[0063], where “end effector 106 may carry the nerve stimulating electrodes 104 on a surface thereof”) and that the one or more electrodes are in conductive connection with the amplifier (¶[0076], where “reusable stimulator tip 818 may include a connector 824 that snaps onto cannula 802 ... the proximal end of reusable stimulator tip 818 may include a low-profile cord 826 electrically coupled to the electrodes … configured to be electrically coupled to the electrical source 304”), the above-described embodiment of Fox does not teach that the one or more electrodes is a plurality of electrodes arranged in an array, each electrode of the array having its own insulated track such that each electrode is capable of being individually in conductive connection with the amplifier system. A second embodiment of Fox teaches that the one or more electrodes is a plurality of electrodes arranged in an array (Figure 7, electrodes 704A-D, ¶[0071], where “As can be seen in FIG. 7, end effector 706 may include four electrodes 704A-D as opposed to two electrodes”), and that each electrode of the array is individually in conductive connection with the amplifier system (¶[0071], where “all four electrodes 704A-D may be coupled to electrical source 304 so that current may be directed through any or all of the electrodes 704A-D”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of a second embodiment of Fox, which teaches the one or more electrodes is a plurality of electrodes arranged in an array and that each electrode of the array is individually in conductive connection with the amplifier system, with the modified invention of Fox in order to allow a user to selectively stimulate certain areas in contact with end effector to more precisely stimulate and identify/locate a target nerve (Fox ¶[0071]). Neither embodiment of Fox teaches each electrode of the array having its own insulated track. Azure teaches each electrode of the array having its own insulated track (¶[0056], where “probe 80 includes a plurality of electrode elements 82 disposed longitudinally along the surface of an expandable member 84, with each electrode element 82 independently addressed by electrical couples 86 (e.g., conductive cables, insulated wires, or the like) passing along (e.g., embedded in the probe body) or through the probe shaft 88 and out the proximal end. Various electrode patterns and configurations can be included in probe designs according to the present invention, and probes described herein will not be limited to any particular pattern or design.” Examiner takes the position that the electrical couples, which are taught to be insulated wires, are a portion of each electrode element, as the couples are connected to each electrode element, where the insulating portion comprises a track to allow the insulated wires to travel to the electrode elements and out of the proximal end.). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Azure, which teaches each electrode of the array having its own insulated track, with the modified invention of Fox in order to couple the electrode elements of the expandable member to the proximal end and/or an externally positioned controller and/or power source (Azure ¶[0012]) and since the insulation allows for more precise energy delivery and current establishment at the desired location (Azure ¶[0059]). Regarding claim 33, Fox as modified in combination with Shantha, Du, and Azure teaches all limitations of claim 32 as described in the rejection above. Furthermore, regarding claim 33, see the rejection of claim 5 above. Regarding claim 34, Fox as modified in combination with Shantha, Du, and Azure teaches all limitations of claim 33 as described in the rejection above. Furthermore, regarding claim 34, see the rejection of claim 6 above . 07-22-aia AIA Claim s 52 and 53 are rejected under 35 U.S.C. 103 as being unpatentable over Fox, Du, and Azure as applied to claim 51 above, and further in view of Shantha . Regarding claim 52, Fox in combination with Du and Azure teaches all limitations of claim 51 as described in the rejection above. Although Fox teaches insertion of a balloon through the nasal cavity to treat a target area, such as a target nerve or the nasal mucosa (¶[0061], where “device 100 may include a hand piece 110 and cannula or probe shaft 102 which is shown after it is inserted in the nasal cavity 160 of a subject's nose 150,” ¶[0062], where “Operation of a system with device 100 with stimulating electrodes 104 to stimulate and identify a target nerve … For example, cannula 102 and electrodes 104 may be configured to reach a region of the nasal mucosa covering a medial pterygoid plate of sphenoid bone through a passage of a middle nasal meatus”), none of Fox, Du, nor Azure explicitly teaches that the cranial nerve is an olfactory nerve. Shantha teaches that the cranial nerve is an olfactory nerve (¶[0184], where “the inventive device placed on the olfactory nerve embedded olfactory mucosa to stimulate the olfactory mucosa”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Shantha, which teaches that the cranial nerve is an olfactory nerve, with the modified invention of Fox in order to stimulate the olfactory mucosa (Shantha ¶[0184]). Regarding claim 53, Fox in combination with Du, Azure, and Shantha teaches all limitations of claim 52 as described in the rejection above. Fox teaches that the inflatable balloon is advanced through the nasal cavity such that it is positioned proximal to an olfactory epithelium (Figure 2, ¶[0067], where “end effector 106 may expand so as to position electrodes 104 in a desired location”) . 07-22-aia AIA Claim s 35 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Fox, Shantha, Du, and Azure as applied to claim 31 above, and further in view of Townley . Regarding claim 35, Fox in combination with Shantha, Du, and Azure teaches all limitations of claim 31 as described in the rejection above. Furthermore, regarding claim 35, see the rejection of claim 7 above. Regarding claim 38, Fox in combination with Shantha, Du, and Azure teaches all limitations of claim 31 as described in the rejection above. None of Fox, Shantha, Du, nor Azure teaches that the flexible arm is steerable. Townley teaches that the flexible arm is steerable (¶[0051], where “the shaft 208 can be a steerable device (e.g., a steerable catheter) with a small bend radius (e.g., a 5 mm bend radius, a 4 mm bend radius, a 3 mm bend radius or less) that allows the clinician to navigate through the tortuous nasal anatomy. The steerable shaft can further be configured to articulate in at least two different directions”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Townley, which teaches that the flexible arm is steerable, with the modified invention of Fox in order to allow the clinician to navigate through the tortuous nasal anatomy (Townley ¶[0051]) . 07-22-aia AIA Claim s 83 and 85 are rejected under 35 U.S.C. 103 as being unpatentable over Fox, Du, and Azure as applied to claim s 1 and 51 above, and further in view of Lindenthaler et al. (hereinafter “Linden”) (U.S. Pub. No. 2016/0067485 A1) . Regarding claim 83, Fox in combination with Du and Azure teaches all limitations of claim 1 as described in the rejection above. Fox teaches an electrical pulse stimulator (¶[0018], where “introducing an electrical current through the electrodes may include delivering electric pulses through the electrodes at a frequency of 0.5 to 12 impulses per second”). Du teaches nerve-regenerating pulses to yield the nerve-regenerative electrical stimulation (Page 2, Col. 1, ¶ 3, where “Implantable stimulating electrodes that we designed … were encircled proximally and distally around the trunk of the nerve relative to the injured site,” Page 2, Col. 2, ¶ 2, where “In the stimulation group, dogs received direct stimulation with non-continuous, rectangular, 20-ms bipolar current pulses per phase (Powerlab System, AD Instruments Pty Ltd., Castle Hill, Australia) at a frequency of 5 Hz, 1 hour per day for 2 consecutive weeks,” Page 3, Col. 2, ¶ 2, where “Our method of chronically stimulating the oculomotor nerve enhanced its regeneration. After 2 weeks of chronic electrical stimulation, spontaneous MUP amplitudes in the stimulation group showed considerably more improvement than they did in the control group”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Du, which teaches nerve-regenerating pulses to yield the nerve-regenerative electrical stimulation, with the modified invention of Fox in order to functionally recover damaged nerves (Du Page 3, Col. 2, ¶ 2). None of Fox, Du, nor Azure teach a continuous train of pulses for over one hour. Linden teaches endoscopically controlled, minimally invasive positioning of an electrode or electrodes (¶[0114]), and further teaches a continuous train of pulses for over one hour (¶[0008], where “Functional electrical stimulation (“FES”) refers to the application of stimulation devices to nerves and muscles to treat medical disorders,” ¶[0038], where “Embodiments of the present invention are based on one or more specific strategies: … continuous stimulation of … the hypoglossal nerve … hypoglossal, vagal or glossopharyngeal nerve branches to these muscles nerve … hypoglossal nerve and/or vagal or glossopharyngeal nerve branches to the palatoglossus, palatopharyngeous, or neighboring pharyngeal muscles, and nerve branches to the thyrohyoid muscle … the FES either targets the effective muscles or the sensory input indirectly affecting the muscles controlling the aforementioned structures … the continuous stimulation may be for a period of hours every day, e.g., preferably, at least 30% or more of each day, or at least 50% or more each day”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Linden, which teaches a continuous train of pulses for over one hour, with the modified invention of Fox in order to sufficiently stimulate the targeted nerve (Linden ¶[0038]). Regarding claim 85, Fox in combination with Du and Azure teaches all limitations of claim 51 as described in the rejection above. Furthermore, regarding claim 85, since the claim is directed to an apparatus comprising substantially the same subject matter of claim 84, it is rejected under substantially the same sections of Fox in combination with Du and Azure . 07-22-aia AIA Claim 84 is rejected under 35 U.S.C. 103 as being unpatentable over Fox, Shantha, Du, and Azure as applied to claim 31 above, and further in view of Linden . Regarding claim 84, Fox in combination with Shantha, Du, and Azure teaches all limitations of claim 31 as described in the rejection above. Fox teaches an electrical pulse stimulator (¶[0018], where “introducing an electrical current through the electrodes may include delivering electric pulses through the electrodes at a frequency of 0.5 to 12 impulses per second”). Du teaches nerve-regenerating pulses to yield the nerve-regenerative electrical stimulation (Page 2, Col. 1, ¶ 3, where “Implantable stimulating electrodes that we designed … were encircled proximally and distally around the trunk of the nerve relative to the injured site,” Page 2, Col. 2, ¶ 2, where “In the stimulation group, dogs received direct stimulation with non-continuous, rectangular, 20-ms bipolar current pulses per phase (Powerlab System, AD Instruments Pty Ltd., Castle Hill, Australia) at a frequency of 5 Hz, 1 hour per day for 2 consecutive weeks,” Page 3, Col. 2, ¶ 2, where “Our method of chronically stimulating the oculomotor nerve enhanced its regeneration. After 2 weeks of chronic electrical stimulation, spontaneous MUP amplitudes in the stimulation group showed considerably more improvement than they did in the control group”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Du, which teaches nerve-regenerating pulses to yield the nerve-regenerative electrical stimulation, with the modified invention of Fox in order to functionally recover damaged nerves (Du Page 3, Col. 2, ¶ 2). None of Fox, Shantha, Du, nor Azure teach a continuous train of pulses for over one hour. Linden teaches endoscopically controlled, minimally invasive positioning of an electrode or electrodes (¶[0114]), and further teaches a continuous train of pulses for over one hour (¶[0008], where “Functional electrical stimulation (“FES”) refers to the application of stimulation devices to nerves and muscles to treat medical disorders,” ¶[0038], where “Embodiments of the present invention are based on one or more specific strategies: … continuous stimulation of … the hypoglossal nerve … hypoglossal, vagal or glossopharyngeal nerve branches to these muscles nerve … hypoglossal nerve and/or vagal or glossopharyngeal nerve branches to the palatoglossus, palatopharyngeous, or neighboring pharyngeal muscles, and nerve branches to the thyrohyoid muscle … the FES either targets the effective muscles or the sensory input indirectly affecting the muscles controlling the aforementioned structures … the continuous stimulation may be for a period of hours every day, e.g., preferably, at least 30% or more of each day, or at least 50% or more each day”). It would have been obvious to one of ordinary skill in the art at the time of the invention to combine the above-described teachings of Linden, which teaches a continuous train of pulses for over one hour, with the modified invention of Fox in order to sufficiently stimulate the targeted nerve (Linden ¶[0038]). Allowable Subject Matter Regarding claim 56, Examiner notes that claim 56 contains allowable subject matter. Although Fox teaches recording electrical signals from a nasal nerve (¶[0015], where “In many embodiments of the method the target nasal nerve may be identified by observing or measuring a response to the stimulation applied”), none of the cited references, nor any references found by Examiner, teach the limitation of “determining that olfactory receptor neurons of the olfactory epithelium are injured or dysfunctional based on recording the electrical signal from the olfactory nerve.” Therefore, claim 56 would be allowable if the rejection of independent claim 51 under 35 U.S.C. 103 is overcome. Conclusion 07-40 AIA 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 SEFRA D. MANOS whose telephone number is (703)756-5937. The examiner can normally be reached M-F: 7:00 AM - 3:30 PM ET. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /SEFRA D. MANOS/ Examiner, Art Unit 3792 /UNSU JUNG/ Supervisory Patent Examiner, Art Unit 3792 Application/Control Number: 18/044,970 Page 2 Art Unit: 3792 Application/Control Number: 18/044,970 Page 3 Art Unit: 3792 Application/Control Number: 18/044,970 Page 4 Art Unit: 3792 Application/Control Number: 18/044,970 Page 5 Art Unit: 3792 Application/Control Number: 18/044,970 Page 6 Art Unit: 3792 Application/Control Number: 18/044,970 Page 7 Art Unit: 3792 Application/Control Number: 18/044,970 Page 8 Art Unit: 3792 Application/Control Number: 18/044,970 Page 9 Art Unit: 3792 Application/Control Number: 18/044,970 Page 10 Art Unit: 3792 Application/Control Number: 18/044,970 Page 11 Art Unit: 3792 Application/Control Number: 18/044,970 Page 12 Art Unit: 3792 Application/Control Number: 18/044,970 Page 13 Art Unit: 3792 Application/Control Number: 18/044,970 Page 14 Art Unit: 3792 Application/Control Number: 18/044,970 Page 15 Art Unit: 3792 Application/Control Number: 18/044,970 Page 16 Art Unit: 3792 Application/Control Number: 18/044,970 Page 17 Art Unit: 3792 Application/Control Number: 18/044,970 Page 18 Art Unit: 3792 Application/Control Number: 18/044,970 Page 19 Art Unit: 3792 Application/Control Number: 18/044,970 Page 20 Art Unit: 3792 Application/Control Number: 18/044,970 Page 21 Art Unit: 3792 Application/Control Number: 18/044,970 Page 22 Art Unit: 3792 Application/Control Number: 18/044,970 Page 23 Art Unit: 3792 Application/Control Number: 18/044,970 Page 24 Art Unit: 3792 Application/Control Number: 18/044,970 Page 25 Art Unit: 3792 Application/Control Number: 18/044,970 Page 26 Art Unit: 3792 Application/Control Number: 18/044,970 Page 27 Art Unit: 3792 Application/Control Number: 18/044,970 Page 28 Art Unit: 3792 Application/Control Number: 18/044,970 Page 29 Art Unit: 3792 Application/Control Number: 18/044,970 Page 30 Art Unit: 3792 Application/Control Number: 18/044,970 Page 31 Art Unit: 3792 Application/Control Number: 18/044,970 Page 32 Art Unit: 3792 Application/Control Number: 18/044,970 Page 33 Art Unit: 3792 Application/Control Number: 18/044,970 Page 34 Art Unit: 3792 Application/Control Number: 18/044,970 Page 35 Art Unit: 3792 Application/Control Number: 18/044,970 Page 36 Art Unit: 3792 Application/Control Number: 18/044,970 Page 37 Art Unit: 3792 Application/Control Number: 18/044,970 Page 38 Art Unit: 3792 Application/Control Number: 18/044,970 Page 39 Art Unit: 3792 Application/Control Number: 18/044,970 Page 40 Art Unit: 3792 Application/Control Number: 18/044,970 Page 41 Art Unit: 3792 Application/Control Number: 18/044,970 Page 42 Art Unit: 3792 Application/Control Number: 18/044,970 Page 43 Art Unit: 3792 Application/Control Number: 18/044,970 Page 44 Art Unit: 3792 Application/Control Number: 18/044,970 Page 45 Art Unit: 3792
Prosecution Insights