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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/03/2025 has been entered.
Status of the Claims
Pursuant to the amendment dated 10/03/2025, claims 2-4, 6, 10-14, and 18-21 have been cancelled.
Claims 1, 5, 7-9, and 15-17 are pending and under current examination.
All rejections not reiterated have been withdrawn.
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 1, 5, 7-9, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chaudry (US200402088830A1, published 21 October 2004; IDS dated 13 October 2022; of record) in view of Meyer et. al. (US20190365728A1, published 5 December 2019; of record).
Chaudry is directed to an aqueous suspension pharmaceutical formulation for the treatment of one or more symptoms of rhinitis via the intranasal route [Abstract].
With regard to claim 1, in the example formulation in Table 3, spanning pages 8-9, Chaudry discloses a nasal spray composition comprising 0.050% fluticasone propionate, microcrystalline cellulose and carboxymethylcellulose sodium in a combined amount of 1.50%, 0.005% polysorbate 80 (i.e. polyoxyethylene (2) sorbitan monooleate), 5.00% dextrose, and the remainder water, wherein all percentages are weight/weight. Although not present in the example composition, Chaudry discloses further that the composition may contain any combination of humectants in an amount of from 0.001% to 5% by weight to inhibit drying of the mucous membrane and prevent irritation. The short list of humectants includes both polyethylene glycol and glycerol (0039). The pH of the composition
It would have been prima facie obvious to add polyethylene glycol and glycerol to the example composition disclosed by Chaudry. The artisan of ordinary skill would have been motivated to do so in order to reduce irritation and drying of the mucous membrane on administration of the drug and would have had reasonable expectation of success because this solution was proposed in the broader disclosure of Chaudry. The ranges in amount of humectant and pH of the composition disclosed by Chaudry overlap with the ranges for polyethylene glycol, glycerin, and pH required by the instant claims. See MPEP 2144.05: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).
Thus, Chaudry teaches a nasal spray formulation comprising: at least one active pharmaceutical ingredient fluticasone propionate or fluticasone furoate in an amount between about 0.005% w/w and about 0.2% w/w; glycerin in an amount between about 0.5% w/w and about 8% w/w; polyethylene glycol present in an amount between about 0.5% w/w and about 20% w/w; dextrose present in an amount between about 0.3% w/w and about 7% w/w; polyoxyethylene (2) sorbitan monooleate in an amount between about 0.0005% w/w and about 0.09% w/w; microcrystalline cellulose and carboxy methylcellulose sodium in an amount between about 0.5% w/w and about 5%w/w; and water in an amount between about 80% w/w/ and about 99% w/w.
Chaudry does not disclose that the polyethylene glycol has a molecular weight of 400.
Meyer, in the analogous art of nasal spray formulations discloses that polyethylene glycol 400 is a humectant (0057).
It would have been prima facie obvious to use PEG400 as the polyethylene glycol humectant in Chaudry’s invention because one having ordinary skill would have recognized this substance to be a species within the genus of polyethylene glycol humectants disclosed by Chaudry, and therefore suitable. See MPEP 2144.07.
Regard tin claims 1 and 7, Although Chaudry discloses adding tonicity adjusting agents, Chaudry does not disclose the tonicity of the composition.
Meyer discloses an osmolarity is in the range of 200 to 1500 mOsm/kg (mOsmoles = mOsm/L (1L=1kg)) for their nasal spray composition (0052). In addition, Meyer discloses an acceptable solvent for the formulation may be isotonic sodium chloride solution (0081).
It would have been prima facie obvious to adjust the tonicity of Chaudry’s composition to be isotonic and falling within the claimed range for mOsmoles required by the instant claims. One having ordinary skill in the art would have been motivated to formulate the composition as an isotonic solution for compatibility with the mucous membrane of the nose and would have had reasonable expectation of success because Chaudry teaches addition of tonicity adjusting agents, and Meyer discloses solutions and a target range in Osmolarity.
Regarding claim 5, as noted above, Chaudry’s example contains fluticasone propionate.
With regard to claims 8 and 9, as noted above, Chaudry’s example contains dextrose. Chaudry teaches that the dextrose serves as a tonicity adjusting agent and also teaches that sodium chloride can be a tonicity adjusting agent (0041).
Regarding claim 15, Chaudry discloses that particle size of the drug in suspension is important for effective delivery (abstract) but does not disclose the droplet size of the spray.
Meyer discloses the particle size of the formulation when applied should be less than 100um to less than 10um (0195). With Dv(50) of about 20 to 150um, with further disclosure of ranges including 20 to 50um, 30 to 90um, 35 to 85um (i.e., about half of the droplets), among others and inclusive of all ranges between any of these values. Dv(90) of about 120um, among others (0197; i.e., about 90% of the droplets).
It would have been prima facie obvious to formulate the nasal spray disclosed by Chaudry to have a droplet size within the range disclosed by Meyer because one having ordinary skill would have recognized this range as suitable to achieve drug delivery within the nasal passages. The range disclosed by Meyer overlaps with the range required by the instant claims. See MPEP 2144.05.
Regarding claim 16, Chaudry discloses greater than 90% or about 100% of the drug particles have a particle size of less than 10 microns [0026].
Regarding claim 17, Chaudry discloses the formulation is for the treatment of allergic rhinitis [0018] by administering to the individual one spray into each nostril [Claim 63] where the humectant inhibits dying and prevents irritation [0039] (i.e., feels moisturized).
Response to Arguments
Applicant's arguments filed 10/03/2025 have been fully considered but they are not persuasive.
On page 4, Applicant argues that the cited references do not disclose or suggest the claimed invention and that the present inventors have developed a nasal spray formulation that is effective at treating the symptoms of allergic rhinitis while also alleviating nasal dryness without adversely affecting the stability, efficacy or safety of the formulations.
Applicant’s argument that the prior art does not teach all the claimed limitations has been addressed in the rejection.
Regarding Applicant’s argument that the instant invention achieves effective treatment of allergic rhinitis while also alleviating nasal dryness without adversely affecting the stability, efficacy or safety of the formulations, these features seem to have been achieved or would have been readily achievable by prior art formulations. The formulation Chaudry already includes a humectant, and Chaudry discloses additional humectants that can be used to reduce irritation and reduce dryness of the nasal passages.
Insomuch as this may be an assertion of unexpected results, please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
In the instant case, Applicant has not established any unexpected improvement over the closest prior art.
Conclusion
All claims are rejected, none are allowed.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617