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.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, U.S. Provisional Patent Application No. 62/778,233, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AlA 35 U.S.C. 112, first paragraph for the independent claim (and subsequent dependent claims) of this application.
The Examiner notes that support for the instant claims has been found in the U.S. Provisional Patent Applications dated 4/12/19. As such, the Examiner will be taking the priority date for the instant application for the purposes of examination as 4/12/2019, this being the filing date of multiple U.S. Provisional Applications.
Terminal Disclaimer
The terminal disclaimer filed on October 7, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of the full statutory term of U.S. 12,268,433 has been reviewed and is accepted. The terminal disclaimer has been recorded.
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 4-14 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.
Claims 4-14 are found to be indefinite because Examiner is unsure of their scope. More specifically, the scope of these claims is unclear, since they recite alternative feedback parameters/thresholds for controlling energy delivery. 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.
Claim(s) 1, 3-14, and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Townley, U.S. 2016/0331459 (hereinafter Townley) in view of Subramaniam, U.S. 2015/0141978 (hereinafter Subramaniam) and Vrba, U.S. 2017/0348049 (hereinafter Vrba).
Regarding claim 1, Townley discloses (note figs. 2 and 5A-E) a method for treating a condition within a nasal cavity of a patient, the method comprising: providing a treatment device comprising a treatment element arranged at a distal portion of a shaft of the treatment device, the treatment element comprising a plurality of electrodes arranged in a substantially symmetrical distribution (note paragraphs 78 and 100); operably coupling the treatment device to a console unit via a cable connection (note paragraphs 46-47); advancing the treatment element into the nasal cavity of a subject such that two or more of the plurality of electrodes of the treatment element contact mucosa overlying an area of posterior nasal nerve (PNN) tissue within a posterior region of the nasal cavity (note paragraphs 42 and 58); and controlling, via the console unit, delivery of one or more treatment applications applied via the treatment element, wherein each of the one or more treatment applications comprises delivery of radiofrequency (RF) energy from at least two electrodes of the plurality of electrodes for altering transmission of signals through the PNN tissue (note paragraphs 66 and 75); wherein, prior to delivery of the one or more treatment applications of RF energy, the console unit performs a baseline impedance check (note paragraph 96), wherein the console unit receives an initial impedance measurement via the at least two electrodes of the plurality of electrodes (note paragraph 85) to sense and establish a baseline impedance between the at least two electrodes of the plurality of electrodes and the PNN tissue; and wherein, during subsequent delivery of each of the one or more treatment applications of RF energy, the console unit (note paragraphs 47-48, 85, and 96): receives one or more impedance measurements via the at least two electrodes of the plurality of electrodes to sense continued apposition between the at least two electrodes of the plurality of electrodes and the PNN tissue (note paragraph 96); and provides, via a display, feedback information to an operator (note paragraph 47), said feedback information comprises an impedance measurement, of the one or more impedance measurements received, necessarily indicating whether contact exists between the at least two electrodes of the plurality of electrodes and the PNN tissue; wherein the console unit stores a predetermined maximum parameter for operation of the treatment device, wherein the maximum parameter comprises at least one of a predetermined impedance threshold and a predetermined maximum impedance rise threshold in relation to the initial impedance measurement; wherein the console unit automatically controls the treatment application of RF energy emitted from the at least two electrodes of the plurality of electrodes when a subsequently received impedance measurement reaches the predetermined impedance threshold; and wherein the console unit automatically controls the treatment application of RF energy emitted from the at least two electrodes of the plurality of electrodes when a rise in impedance matches the predetermined maximum impedance rise threshold (note paragraph 47). While Townley discloses the performance of a baseline impedance check (and therefore the performance of a baseline apposition-sensing check is implied), Townley fails to explicitly disclose the performance of a baseline apposition-sensing check (i.e., the performance a baseline check of tissue contact using impedance). Subramaniam teaches (note paragraphs 5, 66, and 72) a similar method that performs a baseline check of tissue contact using impedance. It is well known in the art that the use of such a configuration, which compares subsequent values to a previously-determined acceptable threshold, would result in increased safety and efficiency. Therefore it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have modified the method of Townley (in view of Subramaniam) to perform a baseline apposition-sensing check prior to the delivery of energy and subsequent apposition checks, in order to increase safety and efficiency. While this combination of references still fails to explicitly disclose that said displayed feedback information comprises a complex impedance measurement, Vrba teaches (note paragraph 423) a similar method that utilizes any of a variety of feedback parameters (including complex impedance) for assessing tissue contact. It is well known in the art that these different feedback parameters are widely considered to be interchangeable. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed, to have further modified the method of Townley to utilize any of a variety of feedback parameters (including complex impedance) in order to assess tissue contact. This is because this modification would have merely comprised a simple substitution of interchangeable feedback parameters in order to produce a predictable result (see MPEP 2143).
Regarding claim 3, Townley discloses (see above) a method wherein the at least two electrodes of the plurality of electrodes comprise a pair of bipolar electrodes (note paragraph 66).
Regarding claim 4, Townley discloses (see above) a method wherein the treatment element delivers RF energy pursuant to a plurality of treatment parameters, wherein the treatment parameters comprise at least a predetermined time threshold and a predetermined temperature threshold (note paragraphs 47, 55, and 74).
Regarding claim 5, Townley discloses (see above) a method wherein, during delivery of a treatment application of RF energy, the console unit continuously monitors temperature of tissue proximate the PNN tissue based on one or more temperature readings received from at least one temperature sensor of the treatment element (note paragraphs 44, 47, and 74).
Regarding claim 6, Townley discloses (see above) a method wherein the console unit stores a predetermined maximum parameter for operation of the treatment device, wherein the maximum parameter includes at least the predetermined temperature threshold (note paragraph 74).
Regarding claim 7, Townley discloses (see above) a method wherein the console unit automatically controls the treatment application of RF energy emitted from the at least two electrodes of the plurality of electrodes based, at least in part, on the one or more temperature readings to thereby maintain a level of RF energy at a level sufficient to cause therapeutic neuromodulation of PNN tissue while preventing temperature of tissue from exceeding the predetermined temperature threshold, wherein the predetermined temperature threshold is less than 90°C (note paragraph 55).
Regarding claim 8, Townley discloses (see above) a method wherein the console unit automatically terminates the treatment application of RF energy when the temperature reaches the predetermined temperature threshold (note paragraphs 47 and 74).
Regarding claim 9, Townley discloses (see above) a method wherein said feedback information further comprises an actual temperature of tissue during delivery of RF energy thereto (note paragraphs 47-48).
Regarding claim 10, Townley discloses (see above) a method wherein, during delivery of a treatment application of RF energy, the console unit continuously monitors a treatment delivery time (note paragraph 47).
Regarding claim 11, Townley discloses (see above) a method wherein the console unit stores a predetermined maximum parameter for operation of the treatment device, wherein the maximum parameter includes at least the predetermined time threshold (note paragraph 47).
Regarding claim 12, Townley discloses (see above) a method wherein the console unit automatically controls the treatment application of RF energy emitted from the at least two electrodes of the plurality of electrodes, based, at least in part, on elapsed time, to thereby maintain delivery of RF energy of the given treatment application for a predetermined treatment delivery time period and maintain a level of RF energy at a level sufficient to cause therapeutic neuromodulation of PNN tissue, wherein the predetermined treatment delivery time period is about 10 seconds to about 12 seconds (note paragraph 55).
Regarding claim 13, Townley discloses (see above) a method wherein the console unit automatically terminates the treatment application of RF energy when the elapsed time reaches the predetermined time threshold (note paragraph 47).
Regarding claim 14, Townley discloses (see above) a method wherein said feedback information further comprises the treatment delivery time (note paragraphs 47-48).
Regarding claim 17, Townley discloses (see above) a method wherein the console unit comprises an energy generator configured to generate RF energy to be delivered by the at least two electrodes of the plurality of electrodes (note paragraphs 45 and 73).
Regarding claim 18, Townley discloses (see above) a method wherein the console unit incorporates a user interface to control, monitor, and regulate RF energy delivery to tissue by the treatment device and the treatment element (note paragraph 47).
Regarding claim 19, Townley discloses (see above) a method wherein the treatment device includes a handle arranged on a proximal portion of the shaft, and the treatment element is disposed at a distal tip of the shaft and the plurality of electrodes includes electrodes which are disposed in a side-by-side arrangement (note paragraph 69).
Regarding claim 20, Townley discloses (see above) a method wherein the condition is selected from the group consisting of allergic rhinitis, non-allergic rhinitis, chronic rhinitis, acute rhinitis, chronic sinusitis, acute sinusitis, chronic rhinosinusitis, acute rhinosinusitis, and medical resistant rhinitis (note abstract; paragraph 3).
Response to Arguments
Applicant's arguments filed June 9, 2026 have been fully considered but they are not persuasive. Regarding Applicant’s arguments that the amended claims are not met by the rejections, Examiner respectfully disagrees. More specifically, Examiner maintains that all of the claims have been met by the cited combination of references, as can be seen above (also note paragraph 47 of Townley). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Therefore, Examiner asserts that the claims are still met by the cited references, as they are currently written.
Conclusion
THIS ACTION IS MADE FINAL. 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 THOMAS ANTHONY GIULIANI whose telephone number is (571)270-3202. The examiner can normally be reached Mon - Fri 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS A GIULIANI/Primary Examiner, Art Unit 3794
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