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 .
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.
Response to Amendment
Claims 1, 4-7, and 9 have been amended. Claims 2 and 3 have been canceled. Claims 1 and 4-20 are under examination herein.
Response to Arguments
Applicant's arguments filed 08/07/2026 have been fully considered but they are not persuasive. Applicant argues that neither Townley (US 2020/0179680) nor Townely ‘866 (US 2022/0104866) teach the amended limitations of claim 1, however the Examiner disagrees. Townley ‘866 teaches the use of delivering a treatment element to treat the sino-nasal cavity for headache disorders, while Townley teaches the use of treating neural signals with a treatment device as described in the claimed invention. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Townley ‘866 recognizes that treating sino-nasal cavities can treat headaches, whereas Townley teaches treating sino-nasal cavities with the structure described in the claimed invention.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4-6, and 9-20 are rejected under 35 U.S.C. 103 as being obvious over Townley (US 2020/0179680) in view of Townley ‘866 (US 2022/0104866).
The applied reference has a common assignee and applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Regarding claim 1, Townley teaches “delivering treatment energy to one or more tissues at one or more target sites within a sino-nasal cavity of the patent to thereby cause multipoint interruption and/or multipoint modulation of one or more targeted neural tissues for the treatment of a headache disorder (p.[0002, 0013]).”
Townley teaches “wherein delivery of treatment energy creates targeted micro-lesions in targeted neural tissue to thereby interrupt associated neural signals (p.[0033], most specifically " the plurality of struts contact multiple locations along multiple portions of the anatomical structure and electrodes of the micro-electrode array are configured to emit energy at a level sufficient to create multiple micro-lesions in tissue of the anatomical structure that interrupt neural signals".)”.
Townley teaches “wherein the targeted neural tissue is associated with at least one of anterior ethmoidal nerve (AEN) tissue, posterior nasal nerve (PNN) tissue, and sphenopalatine ganglion (SPG) nerve cells (p.[0128], most specifically "where the end effector 114 is deployed at a treatment site. The treatment site can be 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. In other embodiments, the target site can be elsewhere within the nasal cavity depending on the location of the target nerves.").”
However, note that Townley does not explicitly teach that the method described is for treating a headache disorder, but Townley '866 does in an analogous ablation device. Townley '866 teaches that it is known in the art to treat nerve tissue in the sino-nasal cavity to treat headaches disorders in p.[0076, 0097]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of Townley '866 in Townley. As recognized in Townley '866 p.[0096-0097] "Accordingly, the devices, systems, and methods of the present invention are useful in detecting, identifying, and precision targeting nerves associated with the peripheral nervous system for treatment of corresponding peripheral neurological conditions or disorders... The peripheral neurological conditions or disorders may include, but are not limited to, chronic pain, movement disorders, epilepsy, psychiatric disorders, cardiovascular disorders, gastrointestinal disorders, genitourinary disorders, to name a few. For example, chronic pain may include headaches, complex regional pain syndrome, neuropathy, peripheral neuralgia, ischemic pain, failed back surgery syndrome, and trigeminal neuralgia." The use of the method of Townley '866 in Townley produces predictable results of treating headache disorders.
Regarding claim 4, the limitations of claim 1 are taught as described above. Townley teaches “wherein the targeted micro-lesions cause multiple points of interruption of postganglionic parasympathetic fibers and trigeminal afferent branches to thereby reduce the frequency and intensity of headache disorder-related symptoms (p.[0033] and p.[0046], most specifically "In some embodiments, RF energy is delivered, via the one or more electrodes provided by the proximal segment, at a level sufficient to disrupt one or more neurogenic pathways associated with the condition, such as neurogenic pathways that result in rhinorrhea and/or congestion. In other embodiments, RF energy is delivered, via the one or more electrodes provided by the proximal segment, at a level sufficient to therapeutically modulate one or more postganglionic parasympathetic nerves innervating nasal mucosa at a neurogenic pathway.").”
Regarding claim 5, the limitations of claim 1 are taught as described above. Townley does not specifically teach the interruption of nociceptive C fibers, but Townley '866 does in an analogous ablation device. Townley '866 teaches in p.[0268] that "For example, the end effector (214, 314) of the system 100 may selectively stimulate and/or modulate parasympathetic fibers, sympathetic fibers, sensory fibers, alpha/beta/delta fibers, C-fibers, anoxic terminals of one or more of the foregoing, insulated over non-insulated fibers (regions with fibers), and/or other neural tissue." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of Townley '866 in Townley. As stated in Townley '866 p.[0268], "Therefore, the system 100 provides highly selective neuromodulation therapy specific to targeted neural tissue, and reduces the collateral effects of neuromodulation therapy to non-target structures (e.g., blood vessels)."
Regarding claim 6, the limitations of claim 1 are taught as described above. Townley does not specifically teach the interruption of accessible trigeminal branches associated with PNN tissue, but Townley '866 does in an analogous ablation device. Townley '866 teaches in p.[0096] that "The device 102 provides access to target sites associated with peripheral nerves for the subsequent neuromodulation of such nerves and treatment of a corresponding peripheral neurological condition or disorder" and moreover, in p.[0097] "The peripheral neurological conditions or disorders may include, but are not limited to, chronic pain, movement disorders, epilepsy, psychiatric disorders, cardiovascular disorders, gastrointestinal disorders, genitourinary disorders, to name a few. For example, chronic pain may include headaches, complex regional pain syndrome, neuropathy, peripheral neuralgia, ischemic pain, failed back surgery syndrome, and trigeminal neuralgia." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of Townley '866 in Townley. As stated in Townley '866, "the devices, systems, and methods of the present invention are useful in detecting, identifying, and precision targeting nerves associated with the peripheral nervous system for treatment of corresponding peripheral neurological conditions or disorders." and one of ordinary skill in the art would recognize that Townley '866 and Townley are both attempts at solving the same problem (targeting and precisely treating nerves associated with peripheral neurological conditions) and produce predictable results.
Regarding claim 9, the limitations of claim 1 are taught as described above. Townley does not specifically teach the interruption of nociceptive C fibers, but Townley '866 does in an analogous ablation device. Townley '866 teaches in p.[0268] that "For example, the end effector (214, 314) of the system 100 may selectively stimulate and/or modulate parasympathetic fibers, sympathetic fibers, sensory fibers, alpha/beta/delta fibers, C-fibers, anoxic terminals of one or more of the foregoing, insulated over non-insulated fibers (regions with fibers), and/or other neural tissue." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the method of Townley '866 in Townley. As stated in Townley '866 p.[0268], "Therefore, the system 100 provides highly selective neuromodulation therapy specific to targeted neural tissue, and reduces the collateral effects of neuromodulation therapy to non-target structures (e.g., blood vessels)."
Regarding claim 10, the limitations of claim 1 are taught as described above. Townley does not specifically teach that the headache disorder is selected from a group consisting of migraine, tension-type headache (TTH), cluster headache (CH) or trigeminal neuralgia and medication-overuse headache, but Townley '866 does in an analogous ablation device. Townley '866 contemplates the use of such an analogous device for the treatment of migraine headaches and trigeminal neuralgia in p.[0096-0097] which states "Accordingly, the devices, systems, and methods of the present invention are useful in detecting, identifying, and precision targeting nerves associated with the peripheral nervous system for treatment of corresponding peripheral neurological conditions or disorders. The peripheral neurological conditions or disorders may include, but are not limited to, chronic pain, movement disorders, epilepsy, psychiatric disorders, cardiovascular disorders, gastrointestinal disorders, genitourinary disorders, to name a few. For example, chronic pain may include headaches, complex regional pain syndrome, neuropathy, peripheral neuralgia, ischemic pain, failed back surgery syndrome, and trigeminal neuralgia." It would have been obvious to one of ordinary skill in the art to use the method of Townley '866 in Townley. As stated in Townley '866 p.[0076], "Peripheral nerve stimulation has become established for very specific clinical indications, including certain complex regional pain syndromes, pain due to peripheral nerve injuries, and the like. Some of the common applications of peripheral nerve stimulation include treatment of back pain, occipital nerve stimulation for treatment of migraine headaches" and produces predictable results.
Regarding claim 11, the limitations of claim 1 are taught as described above. Townley teaches “wherein the multipoint interruption is accomplished by ablating neural tissue (p.[0095] specifically "Statistically meaningful (e.g., measurable or noticeable) decreases in the ENG signal(s) taken after neuromodulation can serve as an indicator that the nerves were sufficiently ablated." which demonstrates that neural tissue is ablated specifically to teach the claimed limitation).”
Regarding claim 12, the limitations of claim 11 are taught as described above. Townley teaches “wherein the ablation is thermal ablation (p.[0134] "The therapeutic neuromodulating effects may include partial or complete denervation via thermal ablation").”
Regarding claim 13, the limitations of claim 12 are taught as described above. Townley teaches “wherein the thermal ablation is cyro-ablation (p.[0085] "In other embodiments, the end effector 114 may include other energy delivery elements configured to provide therapeutic neuromodulation using various other modalities, such as cryotherapeutic cooling").”
Regarding claim 14, the limitations of claim 11 are taught as described above. Townley teaches “wherein the ablation is caused by delivery of radio-frequency (RF) energy (p.[0013] " For example, the first and second sets of electrodes may be configured to deliver RF energy at a level sufficient to therapeutically modulate postganglionic parasympathetic nerves innervating nasal mucosa at an innervation pathway within the nasal cavity of the patient.").”
Regarding claim 15, the limitations of claim 1 are taught as described above. Townley teaches “wherein the treatment energy is delivered by a device comprising an end effector (Fig. 4, 5A-F, p.[0103-0104]) comprising at least one retractable and expandable segment (p.[0105] "Each of the first and second segments 122, 124 is transformable between a retracted configuration and an expanded deployed configuration...")”.
Regarding claim 16, the limitations of claim 15 are taught as described above. Townley teaches “wherein the end effector comprises a plurality of energy delivery elements provided on the at least one segment (p.[0104-0105], 136 in Fig 5C-D).”.
Regarding claim 17, the limitations of claim 16 are taught as described above. Townley teaches “wherein, when in an expanded, deployed state, the at least one segment positions one or more of the plurality of energy delivery elements relative to the one or more target sites.(Fig. 5A-D and p.[0105] which describes and shows how the device expands and treats multiple target sites)”.
Regarding claim 18, the limitations of claim 15 are taught as described above. Townley teaches “wherein the at least one retractable and expandable segment comprises a plurality of deformable wires and the plurality of energy delivery elements are operably associated with the plurality of deformable wires (p.[0105] " The first and second sets of support elements comprise deformable composite wires. The composite wires may include a shape memory material, such as nitinol, for example.")”.
Regarding claim 19, the limitations of claim 18 are taught as described above. Townley teaches “wherein the deformable wires comprise shape memory material (p.[0105] " The first and second sets of support elements comprise deformable composite wires. The composite wires may include a shape memory material, such as nitinol, for example.")”.
Regarding claim 20, the limitations of claim 15 are taught as described above. Townley teaches “wherein the end effector is a multi-segment end effector comprising at least a first retractable and expandable segment and a separate and distinct second retractable and expandable segment (Fig. 5A).”.
Claims 7-8 are rejected under 35 U.S.C. 103 as being obvious over Townley (US 2020/0179680) in view of Townley ‘866 (US 2022/0104866) and Townley ‘459 (US 2016/0331459).
Regarding claim 7, the limitations of claim 1 are taught as described above. Townley/Townley ‘866 does not teach the use of disrupting AEN tissue specifically, but Townley '459 does in an analogous tissue ablation device. Townley '459 teaches in p.[0140] that "FIG. 20 is a partial cut-away side view illustrating target sites proximate to ostia of nasal sinuses for a therapeutic neuromodulation device configured in accordance with embodiments of the present technology. 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. Referring to FIG. 20, the 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. FIG. 20 illustrates the general locations of the ostium of the frontal sinus, the sphenoidal sinus, the maxillary sinus, and the ostia of posterior, middle, and anterior ethmoidal cells." Townley '459 demonstrates that AEC tissue can be ablated as desired tissue sites, and therefore teaches the claimed limitation. It would have been obvious to one of ordinary skill in the art before the effective filing date to use the method of Townley '459 in Townley/Townley ‘866. As taught in Townley '459, the ablation of these nerves is known and contemplated in the art and the system of Townley '459 is capable of treating this tissue, and moreover, it is desirable to treat such tissue for the treatment of parasympathetic nerve disorders, which is the same problem that Townley/Townley ‘866 is trying to solve.
Regarding claim 8, the limitations of claim 7 are taught as described above. Neither Townley nor Townley '459 explicitly teaches "wherein the treatment energy is delivered at a level sufficient to create the targeted micro-lesions in the AEN tissue without damaging olfactory nerves to thereby preserve olfactory function", however, Townley '459 does teach that AEN tissue can be ablated. Further, analogous ablation device Townley '866 teaches a device that is capable of ablating specific tissues of interest while minimizing or avoiding collateral damage to surrounding or adjacent non-targeted tissue in p.[0121], which states " In certain embodiments, for example, electrodes 244 may be activated across the portion of the basket 242 that is adjacent to tissue at the target site, and the electrodes 244 that are not proximate to the target tissue can remain inactive to avoid applying energy to non-target tissue." It is the Examiner's position that olfactory nerves would constitute non-target tissue under broadest reasonable interpretation, given that olfactory nerves are not defined as a tissue of interest (p.[0007] "In particular, a tissue of interest (i.e., the specific tissue to undergo treatment) may be adjacent to one or more tissues that are not of interest (i.e., tissue that is not intended to undergo treatment).") It would have been obvious to one of ordinary skill in the art to use the system of Townley '866 in Townley/Townley '459. As stated in p.[0007], " In one scenario, a surgeon may wish to provide electrotherapeutic stimulation to a nerve tissue, while avoiding providing any such stimulation to an adjacent blood vessel, for example, as unintended collateral damage may result in damage to the blood vessel and cause further complications. In such a scenario, the specific type of targeted tissue may generally dictate the level of electrical stimulation required to elicit a desired effect. Furthermore, physical properties of the targeted tissue, including the specific location and depth of the targeted tissue, in relation to the non-targeted tissue, further impacts the level of electrical stimulation necessary to result in effective therapeutic treatment."
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abigail M Bock whose telephone number is (571)272-8856. The examiner can normally be reached M-F 7:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (617) 320-2637. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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