DETAILED ACTION
Response to Amendment
The amendment filed November 12, 2025 has been entered. Claim 1 has been amended and claims 1-5, 7, 10-17, 19, and 20 are currently pending in the application.
Response to Arguments
Applicant’s arguments with respect to the rejection(s) of the amended claim(s) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is set forth below.
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) 1-5, 7, 10-13, 16, 17, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Djupesland (US 20090320832) in view of Schuschnig (US 2007/0202051) in view of NPL Komser et al. “Unilateral transnasal endoscopic approach to frontal sinuses: Draf IIc” as evidenced by Kaufman et al. (US 2016/0213890), and further evidenced by Eviatar et al. (NPL “The endoscopic Draf II frontal sinusotomy: non-navigated approach*”).
Regarding claims 1, 4, 5, 19 and 20, Djupesland discloses a method of administering a therapeutic agent including a corticosteroid (paragraph [0015] discloses fluticasone propionate delivery) to a nasal cavity of the patient (paragraphs [0068] and [0080] disclose the delivery at the nasal cavity; also Figures 2-3), wherein the therapeutic agent is administered as a liquid aerosol (paragraph [0075]) via an exhalation delivery device that comprises a mouthpiece (47) and a nosepiece (17), the nosepiece fitted to a first nostril of the patent (Figure 7), wherein the patient exhales into the mouthpiece to create a fluid flow out of the nosepiece and into the first nostril while the therapeutic agent is administered to the patient (paragraph [0089]). Djupesland fails to explicitly disclose wherein the therapeutic is delivered after a Draf 2 or Draf 3 procedure, the claimed dosage of up to 400 µg twice daily, and is specifically delivered to the ethmoid sinus and maxillary sinus.
Komser et al. (henceforth Komser) teaches the performing of Draf 2 and Draf 3 procedures and endoscopic surgery for the nasal sinus (page e82, first paragraph on right side), and particularly for chronic rhinosinusitis.
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of Djupesland to deliver the therapeutic after the procedure taught by Komser so as to deliver the therapeutic to the desired area for treatment. Djupesland teaches that the utilization of a nasal delivery device provides a therapeutic substance to the nasal mucosa in order to reduce inflammation and restore normal nasal function (Col. 1, lines 32-57). Kaufman et al. (henceforth Kaufman) teaches that it is known to provide a corticosteroid after a nasal or sinus surgery such as that taught by Komser for the reduction of inflammation (paragraph [0025]) and Eviatar et al. teaches (Table 2) that sinusitis or sinus inflammation is a known postoperative symptom of Draf II surgery. Therefore, it would have been obvious to one of ordinary skill to provide such treatment as post-operative care after the surgical procedure of Komser so as to reduce inflammation and deliver a target therapeutic to the surgical site as taught by Djupesland and Kaufman.
Palmer teaches a method of providing fluticasone propionate in a range of all of the claimed doses of up to 400 µg depending on the treatment required (Col. 3, lines 31-34) and to be delivered twice daily (as per claims 21-24; Col. 3, lines 26-28).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the treatment method of Djupesland/Komser to comprise providing the corticosteroid in the claimed dosage twice daily as Palmer teaches that such a method of treatment is used for the treatment of disease. The prior art still fails to explicitly disclose the treatment of the ethmoid and maxillary sinuses as claimed.
Schuschnig teaches aerosol sinunasal drug delivery which are delivered to the ethmoid and maxillary sinuses as claimed (paragraphs [0023]-[0024] disclose the paranasal sinuses; [0025] and [0027] disclose low-volume delivery to the paranasal sinuses; [0030], [0032], and [0034] disclose pulsating low-volume aerosol delivery to reach the paranasal sinuses through the ostia).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of treatment of Djupesland to provide pulsating aerosol flow into the nasal cavity to treat a variety of sinus conditions which might affect the paranasal sinus including the ethmoid and maxillary sinus cavities (see e.g., paragraph [0013] which discloses a variety of conditions which might be treated in this manner).
Regarding claims 2 and 3, Djupesland further discloses wherein the corticosteroid is fluticasone propionate (e.g., paragraph [0015]).
Regarding claim 7, Djupesland further discloses wherein the therapeutic agent is delivered using a spray pump (paragraph [0073]).
Regarding claims 10-12, Palmer further teaches a method of providing fluticasone propionate in a range of all of the claimed doses depending on the treatment required (Col. 3, lines 31-34 disclose all of the claimed dosages) and to be delivered twice daily (Col. 3, lines 26-28).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the treatment method of Djupesland/Komser/Schuschnig to comprise providing the corticosteroid in the claimed dosage twice daily as Palmer teaches that such a method of treatment is used for the treatment of disease.
Regarding claim 13, Djupesland further discloses controlling a pressure of fluid flow (e.g., between first and second nosepiece sections as per paragraph [0088]).
Regarding claims 16 and 17, Djupesland further discloses a second nosepiece fitted to a second nostril of a patient to create a fluid flow out of the nosepiece and into the second nostril while the therapeutic agent is administered to the patient (paragraph [0158]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Djupesland in view of Komser in view of Schuschnig in view of Palmer, and further in view of Djupesland (US 6,715,485).
Regarding claim 14, Djupesland/Komser/Schuschnig/Palmer teach the claimed invention substantially as set forth above for claim 13, but fail to explicitly disclose the flow duration.
Djupesland (henceforth Djupesland ‘485) teaches a nasal delivery device having a flow duration from about 2-3 seconds (Col. 10, lines 45-49).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of Djupesland/Komser/Schuschnig/Palmer to comprise controlling a fluid flow duration to be between 2-3 seconds as Djupesland ‘485 teaches that such a flow duration is optimal during a nasal therapeutic delivery cycle.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Djupesland in view of Komser in view of Schuschnig in view of Palmer, and further in view of Djupesland (US 2015/0101605).
Regarding claim 15, Djupesland/Komser/Schuschnig/Palmer teach the claimed invention substantially as set forth above for claim 13, but fail to explicitly disclose the fluid flow rate.
Djupesland (henceforth Djupesland ‘605) teaches a nasal powder delivery device having a flow rate of at least 10 l/min (paragraph [0045]).
It would have been obvious to one of ordinary skill in the art at the time of filing to modify the method of Djupesland/Komser/Schuschnig/Palmer to comprise a flow rate through the device of at least 10 l/min as Djupesland ‘605 teaches that such a method of use for a nasal delivery device is known for delivering therapeutic substances to a target location.
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.
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/JUSTIN L ZAMORY/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783