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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/31/2025, 07/25/2025, 07/11/2025, and 05/14/2025 was filed after the mailing date of the application on 09/24/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 34 and 46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 34, the claim recites the limitation "those sensed nerves" in the last limitation. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Regarding claim 46, the claim recites the limitation “the stylus”. There is insufficient antecedent basis for this limitation in the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 27, 29-32, 35-40, and 43-46 are rejected under 35 U.S.C. 103 as being unpatentable over Townley (US 2016/0331459) in view of Underwood (US 2005/0234439).
Regarding claims 27, 38, 43, and 44, Townley teaches “A device for treating nasal airway tissue, the device comprising a handle (210); a shaft extending from a distal end of the handle (208); a distal tip extending from a distal end of the shaft; the distal tip comprising (Fig. 4, 412), a treatment surface (Fig. 4); a plurality of rows of bipolar radiofrequency electrodes on the treatment surface configured to contact and treat a first target tissue (Fig. 4, with "rows of electrodes" 444, p.[0066] "The electrodes 444 can apply bipolar or multi-polar radiofrequency (RF) energy to the target site to therapeutically modulate postganglionic parasympathetic nerves that innervate the nasal mucosa proximate to the target site"); a temperature sensing member on the treatment surface (p.[0074] "in various embodiments, the temperature sensors 452 can be positioned proximate to the electrodes 444 to detect the temperature at the interface between tissue at the target site and the electrodes 444.")”.
Townley does not teach an expandable wire electrode, but Underwood does in an analogous radiofrequency ablation device. Underwood teaches an expandable wire electrode component (362) in Figure 12B-D, with the capacity to be bipolar (p.[0158]) located along the length of the wire electrode. The use of the wire electrode is a mere matter of design choice and would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. As stated in Underwood, " Of course, the active electrode 362 may have a variety of configurations to increase the current densities on its surfaces, e.g., a conical shape tapering to a distal point, a hollow cylinder, loop electrode and the like" showing that it is known in the art to modify the shape of the electrode to achieve the desired electrical ablation results (p.[0146]). Underwood teaches that the electrode is able to be advanced from one target tissue to another in p.[0070], which describes that the electrode or treatment effector can be expanded to "press against surrounding anatomical structures" and "facilitate placing electrodes 444 in contact with the surrounding tissue at the target site", suggesting that a plurality (including a first and second) of treatment sites can be chosen and treated.
Regarding claim 44 specifically, MPEP 2112.02 I states “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986)”. The apparatus of claim 27 and 38 would inherently perform the method of claim 44, and therefore, the rejection of method claim 44 is taught by the rejection of claim 27 and 33.
Regarding claim 29, the limitations of claim 27 are taught as described above. Townley teaches “wherein the first target tissue is one of a posterior nasal nerve tissue, turbinates, and nasal swell bodies” in p.[0042] which states "for example, the therapeutic assembly 212 can therapeutically modulate the postganglionic parasympathetic nerves branching from the pterygopalatine ganglion and innervating the nasal region and nasal mucosa, such as parasympathetic nerves (e.g., the posterior nasal nerves) traversing the SPF, accessory foramen, and microforamina of a palatine bone."
Regarding claim 30, the limitations of claim 27 are taught as described above. Townley teaches “wherein the first target tissue is one or more nasal turbinates in areas anterior to a posterior nasal nerve” in p.[0090] which states “The location of the neural anatomy can then be used to determine where the treatment site(s) should be with respect to various anatomical structures for therapeutically effective neuromodulation of the targeted parasympathetic nasal nerves. For example, the information can be used to determine the treatment site(s) with respect to the location of the turbinates or meatuses". Although Townley does not explicitly state that the first target tissues are nasal turbinates in areas anterior to a posterior nasal nerve, Townley demonstrates in this passage that any of the neural anatomy can be subject to therapeutic modulation as required or desired for targeted parasympathetic nasal nerve treatment.
Regarding claim 31, the limitations of claim 30 are taught as described above. Townley teaches “wherein the second target tissue is the posterior nasal nerve” in p.[0042] which states “for example, the therapeutic assembly 212 can therapeutically modulate the postganglionic parasympathetic nerves branching from the pterygopalatine ganglion and innervating the nasal region and nasal mucosa, such as parasympathetic nerves (e.g., the posterior nasal nerves) traversing the SPF, accessory foramen, and microforamina of a palatine bone."
Regarding claims 32 and 40, the limitations of claim 27 and 38 are taught as described above. Townley does not explicitly teach the use of an expandable wire electrode, and therefore cannot teach that the expandable wire electrode includes one or more thermocouples to measure a temperature of nasal mucosa, but Underwood does in an analogous nasal modulation device. Underwood teaches in p.[0177] that "In this embodiment, the probe may include one or more temperature sensors (not shown) on probe coupled to one or more temperature displays on the power supply 28 such that the physician is aware of the temperature within the hole 702 during the procedure." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a thermocouple (or temperature sensor) in the system of Townley/Underwood as taught in Underwood. As stated in Underwood p.[0177], the use of the temperature sensor allows the physician to be aware of the temperature of the treated tissue to create scar tissue and produces predictable results. Indeed, Townley also uses a temperature sensor (although not on an expandable wire electrode), demonstrating that it is known in the art to use measure the temperature of the treated tissue during ablation.
Regarding claim 35, the limitations of claim 27 are taught as described above. Townley does not teach the use of an expandable wire electrode configured to be activated simultaneously, but Underwood does in an analogous radiofrequency modulation device. Underwood teaches the use of the wire electrode as described above, and further teaches that the system can be configured to allow for simultaneous activation of two different voltages to two different electrodes in p.[0147]. It would have been obvious to one of ordinary skill in the art to use the system of Underwood in Townley. As stated in Underwood, the use of the simultaneous application of the electrodes allows for appropriate ablation or coagulation depending on the location of the electrode and need of the physician and produces predictable results (p.[0147]).
Regarding claim 36, the limitations of claim 27 are taught as described above. Townley does not teach the use of an expandable wire electrode configured to be activated simultaneously, but Underwood does in an analogous radiofrequency modulation device. Underwood teaches the use of selective activation of the electrodes in p.[0144], which details how different modes can result in different electrodes being activated selectively. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selective activation of the electrodes in Townley as taught in Underwood. As stated in Underwood, the use of selective activation allows for the desired clinical effects (ablation versus thermal heating) to be achieved and produces predictable results.
Regarding claims 37 and 39, the limitations of claim 27 and 38 are taught as described above. Townley does not explicitly teach the use of an expandable wire electrode with a loop but Underwood does in an analogous nasal device. Underwood teaches in p.[0146] that "Of course, the active electrode 362 may have a variety of configurations to increase the current densities on its surfaces, e.g., a conical shape tapering to a distal point, a hollow cylinder, loop electrode and the like." 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 system of Underwood in Townley. As recognized in Underwood, the shape of the electrode is a mere matter of design choice and is known in the art for selection based on the desired current densities on the surface and such a modification produces predictable results.
Regarding claim 45, the limitations of claim 44 are taught as described above. Townley teaches “further comprising sensing a temperature of the nasal mucosa with a temperature sensing member located on the treatment surface of the distal tip” in Fig. 4, with temperature sensing member 452 on the treatment surface of the distal tip of the device.
Regarding claim 46, the limitations of claim 45 are taught as described above. Townley teaches “further comprising automatically shutting off delivery of radiofrequency energy from a console to the stylus if the temperature of the nasal mucosa is above a predefined acceptable maximum temperature” in p.[0074] "The temperature measurements can provide the operator or the system with feedback regarding the effect of the therapeutic neuromodulation on the tissue. For example, in certain embodiments the operator may wish to prevent or reduce damage to the tissue at the treatment site (e.g., the nasal mucosa), and therefore the temperature sensors 452 can be used to determine if the tissue temperature reaches a predetermined threshold for irreversible tissue damage. Once the threshold is reached, the application of therapeutic neuromodulation energy can be terminated to allow the tissue to remain intact. In certain embodiments, the energy delivery can automatically terminate based on an evaluation/feedback algorithm (e.g., the evaluation/feedback algorithm 220 of FIG. 2) stored on a console (e.g., the console 204 of FIG. 2) operably coupled to the temperature sensors 452."
Claims 28, 33-34, and 41-42 are rejected under 35 U.S.C. 103 as being unpatentable over Townley (US 2016/0331459) in view of Underwood (US 2005/0234439) and Townley ‘460 (US 2016/0331459).
Regarding claim 28, the limitations of claim 27 are taught as described above. Townley does not teach an expandable wire electrode, but Underwood does in an analogous radiofrequency ablation device. Underwood teaches a wire electrode component (362) in Figure 12B-D, but does not explicitly teach the use of a slider to move the expandable wire electrode component. Townley '460 does teach the use of a slider to move an electrode in p.[0118] which states "Deployment of the implantable device from the delivery system may be driven by sliders, pistons, depression buttons, rotational elements, and/or other actuators at the proximal handle that advance or initiate implantation mechanisms of the delivery system." 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 slider of Townley '460 in Townley/Underwood. As stated in Townley '460, the use of the slider allows for "to control tissue/device interface and the entry angulation" and produces predictable results.
Regarding claims 33 and 41, the limitations of claims 27 and 38 are taught as described above. The Examiner is interpreting "nerve sensor" as an electrode, given the definition provided in the instant application (p.[0104] "… may also include one or more thermocouples and/or multiple nerve sensors (such as electrodes)…"). Neither Townley nor Underwood teach of an electrode that is configured to sense a location of nerve tissue under nasal mucosa, but Townley '460 does in an analogous nasal modulation device. Townley '460 teaches in p.[0095] that "] During induced EMF detection, the evaluation/modulation assembly 312 and/or other device including a sensor wire is positioned in contact with tissue at the interest zone and, optionally, one or more of the electrodes 344 can be activated to inject an electrical stimulus into the tissue. As the nerves in the interest zone fire (either in response to a stimulus or in the absence of it), the nerve generates a magnetic field (e.g., similar to a current carrying wire) that induces a current in the sensor wire (e.g., the sensor 314). This information can be used to determine neural location and/or map the nerves (e.g., on a display 322) to identify the location of nerves and select target nerves (nerves with excessive parasympathetic tone) before neuromodulation therapy to ensure that the desired nerves are treated during neuromodulation therapy." See further p.[0096-0099]. 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 electrode nerve sensor of Townley '460 in Townley/Underwood. As stated in Townley '460, the use of a nerve sensor allows for the location of the nerves to be determined and to ensure that the desired nerves are treated during neuromodulation therapy and such modification produces predictable results.
Regarding claims 34 and 42, the limitations of claims 27 and 41 are taught as described above. Neither Townley nor Underwood explicitly teach the use of nerve sensors configured to sense nerves, but Townley '460 does in an analogous nasal modulation device. Townley '460 teaches that the device can use bipolar energy to electrodes (p.[0041]) and that the electrodes can apply energy directly over the desired sensed nerves (p.[0095-0102]), therefore teaching the claimed limitation. 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 electrode nerve sensor of Townley '460 in Townley/Underwood. As stated in Townley '460, the use of a nerve sensor allows for the location of the nerves to be determined and to ensure that the desired nerves are treated during neuromodulation therapy and such modification produces predictable results.
Conclusion
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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/ABIGAIL BOCK/Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
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