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 .
Status of the Claims
Pursuant to the amendment dated 04/01/2026, claim 15 has been cancelled and new claim 22 has been added. Claims 2-4, 6, 10-14, and 18-21 had been cancelled previously.
Claims 1, 5, 7-9, 16, 17, and 22 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All rejections not reiterated have been withdrawn.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, 16, 17, and 22 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). 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. The pH of the composition ranges from 2 to 9 (0035).
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).
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).
Regarding claim 22, as noted above an objective of Chaudry is to inhibit drying of the mucous membrane and prevent irritation, and this is accomplished by adding humectants (i.e. a substance that encourages retention of/absorption of water). It would have been prima facie obvious to optimize the amount and identity of humectant such that the formulation retains sufficient moisture to accomplish the objectives noted above. For this reason, the examiner does not consider the functional language recited in claim 22 to patentably define over the cited prior art.
Response to Arguments
Applicant's arguments filed 04/01/2026 have been fully considered but they are not persuasive.
On pages 6-7, Applicant argues that claim 1 does not recite a combined range of humectant it specifically recites individual amounts of each polyethylene glycol and glycerin and that Chaudry’s cited range covering over 3.5 orders of magnitude of humectant does not overlap with the individual amounts of polyethylene glycol and glycerin recited in the instant claims.
This is not persuasive because it would have been obvious to add any humectant or combination of humectants in amounts within the range disclosed by Chaudry. See MPEP 2144.05. Furthermore, it is noted that Applicants do not identify secondary consideration demonstrating criticality or anything unexpected about the claimed ranges of the two known humectants disclosed by Chaudry as part of their invention (see e.g. Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989)).
On page 7, Applicant argues that the relative amounts of polyethylene glycol and glycerin are important, citing the instant specification’s para 0043.
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.
Applicant’s comment that the glycerin and PEG affect viscosity and droplet size is noted. Substances such as glycerin and PEG were certainly known as of the instant effective filing date to affect viscosity and adding any solute was well-established to affect surface tension (which in turn would affect droplet size). Thus, it is unclear what is unexpected about the droplet size observations noted in para 0043. "[A]ppellants [Applicants in the instant case] have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). The examiner notes that pages 7-8 of the specification report results of experiments evaluating water loss of the instant formulation; however, no side by side comparison to the closest prior art has been made of record and the examiner again points out that adding a humectant to an aqueous composition would have been expected to increase water retention.
On page 7, Applicant points out that Meyer does not teach or suggest all limitations of the claims.
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).
Conclusion
All claims are rejected, none are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571)272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617
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