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.
Terminal Disclaimer
The terminal disclaimer filed on December 4, 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. 10,625,073 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 8-11 and 19-25 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 8 and 22 (line 2) both recite the limitation "a level of energy". The antecedent basis for this limitation is confusing, since it’s unclear how/whether it’s related to the previously-recited “delivery of treatment energy… at a level”.
Claim 19 (line 5) recites the limitation "the target site". The antecedent basis for this limitation is confusing, since it’s unclear how/whether it’s related to the previously-recited “one or more target sites”.
It should be noted that all other cited claims have been rejected for being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 5-11, 13, 15, 17, 19-25, and 27 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Townley, U.S. 2018/0133460 (hereinafter Townley).
Regarding claims 1, 3, 15, and 17, Townley discloses (see figs. 3A-B and 7; note abstract and paragraph 31) a system for treating a condition within a sino-nasal cavity of a patient, the system comprising: a treatment device including an ‘end effector’ (312) comprising a plurality of separate ‘support structures’ (each adjacent pair of struts ‘340’ could be interpreted as a single support structure – see fig. 3B), each support structure necessarily having a ‘leaflet’ shape (see fig. 3B) and comprising a respective set of a plurality of electrodes (344); and a controller operably associated with the treatment device and configured to control delivery of treatment energy from the plurality of electrodes to one or more tissues at one or more target sites within the sino-nasal cavity of the patient at a level and for a period of time sufficient to ablate and/or modulate targeted neural tissue for the treatment of a nasal condition while minimizing or preventing collateral damage to ‘surface tissue’ at the one or more target sites (note paragraph 99), wherein the controller is configured to determine a treatment pattern for controlling delivery of energy from the plurality of electrodes to the one or more tissues at the one or more target sites based, at least in part, on identifying data received from the treatment device associated with the one or more tissues, wherein the treatment pattern is determined based on processing, via the controller, the identifying data received from the end effector associated with tissue at the one or more target sites, wherein the identifying data is associated with the one or more properties of the one or more tissues, the one or more properties comprising at least one of a type, a depth, and a location of each of the one or more tissues (note paragraphs 47, 63, and 79). It should be noted that the claimed method would necessarily be met through the routine operation of this device.
Regarding claims 5 and 19, Townley discloses (see above; note abstract, paragraphs 65-66) a system wherein a subset of the plurality of electrodes is configured to deliver non-therapeutic stimulating energy at a frequency/waveform to respective positions at the one or more target sites to thereby sense at least one of physiological properties, bioelectric properties, and thermal properties of the one or more tissues at the one or more target sites. It should be noted that the claimed method would necessarily be met through the routine operation of this device.
Regarding claims 6, 7, 20, and 21, Townley discloses (see above; note paragraphs 55, 76, and 104) a system wherein the processing of the identifying data, via the controller, comprises comparing the identifying data received from the end effector with electric signature data associated with a plurality of known tissue types, wherein the comparison comprises correlating the identifying data received from the end effector with electric signature data from a supervised and/or an unsupervised ‘trained neural network’. It should be noted that the claimed method would necessarily be met through the routine operation of this device.
Regarding claims 8, 9, 22, and 23, Townley discloses (see above; note paragraphs 47 and 60) a system wherein the treatment pattern comprises data associated with at least one of a predetermined treatment time, a level of energy to be delivered from the plurality of electrodes, and a predetermined current density threshold, wherein the treatment energy is delivered based, at least in part, on processing, via the controller, of real-time feedback data associated with the one or more tissues upon supplying the treatment energy thereto. It should be noted that the claimed method would necessarily be met through the routine operation of this device.
Regarding claims 10, 11, 24, and 25, Townley discloses (see above; note paragraphs 37, 38, and 57) a system wherein the feedback data comprises at least current density measurement data associated with the targeted tissue, the level of energy delivered, and an elapsed delivery time, wherein the controller is configured to process the feedback data using an algorithm to determine efficacy of ablation/modulation of the targeted tissue based, at least in part, on a comparison of the feedback data with treatment pattern data. It should be noted that the claimed method would necessarily be met through the routine operation of this device.
Regarding claims 13 and 27, Townley discloses (see above; note paragraph 81) a system wherein the energy delivered disrupts multiple neural signals to mucus producing and/or mucosal engorgement elements, thereby reducing production of mucus and/or mucosal engorgement within a nose of the patient and reducing or eliminating one or more symptoms associated with rhinosinusitis. It should be noted that the claimed method would necessarily be met through the routine operation of this device.
Response to Arguments
Applicant's arguments filed December 4, 2025 have been fully considered but they are not persuasive. Regarding Applicant’s arguments concerning the references of record, Examiner respectfully disagrees. More specifically, Examiner maintains that the claims have been met by Townley as they are currently written, due to the breadth of limitations such as “end effector,” “support structure,” and “leaflet shape” (see above rejections for current interpretation). Therefore, Examiner asserts that the claims are still met in view of the cited references, as can be seen above.
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