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 .
Priority
The instant application was filed 31 October 2022 and claims priority to foreign application IN201921053286 filed 15 June 2020. The instant application is the national stage entry of PCT/IB2021/055222 filed 14 June 2021. The effective filing date of the instant application is 15 June 2020.
Examiner’s Note
The Applicant's amendments and/or arguments filed 30 July 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections
and/or objections not reiterated from previous office actions are hereby withdrawn. The
following rejections and/or objections are either reiterated or newly applied. They constitute the
complete set presently being applied to the instant application. In the Applicant’s response, filed
30 July 2025, it is noted that claims 14-16 have been amended and claim 29 has been newly added. Support for the amendment(s) and/or new claim(s) can be found in para. 14 of the specification. No new matter has been added.
Claim Rejections - 35 USC § 103
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.
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) 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ignar et al. (WO 2014/095602 A1) and Abelson et al. (Think Globally, Treat Locally: Treating Allergic Rhinitis, 2011).
Ignar et al. teach an aqueous formulation capable of intranasal delivery or eye drops (entire teaching, pg. 4, lns 1-6) with a pH around 6-8 (pg. 4, lns. 27-29). The composition may comprise an H1 antagonist such as levocabastine (pg. 1, lns. 1-5) in about 0.0005-2% (pg. 5, lns. 17-21), fluticasone furoate in about 0.055% (pg. 11, Example 1), sodium chloride in an amount of 0.1-10% (pg. 7, lns. 3-11), monosodium phosphate as a buffer (pg. 4, lns. 30-36), EDTA in an amount of 0.001-1% (pg. 6, lns. 18-20), benzlkonium chloride in an amount of 0.001-1% (pg. 6, lns. 21-22), polysorbate 80 in an amount of about 0.0275% (pg. 11, Example 1), and Avicel CL611 in an amount of 0.1-5% (pg. 5, ln. 26; pg. 6, lns. 4-7). Avicel CL611 is an example of a co-spray dried combination of microcrystalline cellulose and sodium carboxymethylcellulose (Applicant’s specification, para. 101). In regards to the amount of monodium phosphate, Ignar teaches 100 mL of 4 mM sodium phosphate buffer in one example (pg. 13, lns. 10-12). However, since monosodium phosphate is used as a buffer, it is interpreted that one of ordinary skill in the art would be have been led to optimize the amount of buffer based on how much the skilled artisan desired to adjust the pH.
Ignar does not teach alcaftadine in their composition in claims 14-16.
Abelson teaches that there is a physical relationship between the eye and nose wherein antihistamine ophthalmic drugs, such as alcaftadine (a dual-acting H1 antihistamine, pg. 5), may be used to address nasal allergy symptoms (entire teaching, pg. 2).
In regards to selecting the combination of the components described in Ignar, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combination of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Ignar teaches an intranasal composition comprising a H1 antagonist, whereas the claimed invention is directed towards an aqueous nasal composition comprising alcaftadine. Since Ignar teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Since Ignar teaches an aqueous nasal composition comprising levocabastine, which is a H1 antagonist, one of ordinary skill in the art would have been led to use the teaching of alcaftadine as a H1 antagonist from Abelson in claims 14-16. A person of ordinary skill in the art would have been motivated to use alcaftadine as an obvious alternative to levocabastine to address allergy-related conditions, as taught in Ignar. Further, Abelson teaches a link between antihistamine drugs typically used to treat eye allergies and their positive results in treating nasal allergy symptoms. Therefore, one of ordinary skill in the art would have been led to combine the teachings with a reasonable expectation of success.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists, thus addressing the % amounts of components in claim(s) 14-16. Further, the amounts are interpreted broadly considering the Applicant’s use of “about.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). MPEP 2144.05 (I).
Claim(s) 14-16, 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ignar et al. (WO 2014/095602 A1), Abelson et al. (Think Globally, Treat Locally: Treating Allergic Rhinitis, 2011), and Simons et al. (Histamine and H1-antihistamines: Celebrating a century of progress, J Allergy Clin Immunol, 2011).
In regards to claim(s)14-16, Ignar and Abelson, as applied supra, is herein applied in its entirety for its teachings of a nasal spray comprising alcaftadine.
Ignar does not specifically teach an onset of action for alcaftadine in claim 29.
Simons teaches that intranasal H1-antihistamine formulations have a rapid onset of action, for example, 15 minutes for some formulations (pg. 1142, right column). Ophthalmic alcaftadine has an onset of action of 0.05 h (pg. 1150).
Since Ignar does not specifically teach an onset of action for alcaftadine in claim 29, one of ordinary skill in the art would have been motivated to use Simons’ teaching that intranasal H1-antihistamine formulations have a rapid onset of action with ophthalmic formulations of 0.25% alcaftadine (Table C) having an onset of action of 0.05 h (3 mins) with a reasonable expectation of success. One of ordinary skill in the art would have been led to combine the teachings because Ignar teaches an eye drop or intranasal allergy formulation, Abelson teaches that alcaftadine is useful in treating nasal allergy symptoms, and Simons teaches that an ophthalmic solution of alcaftadine has an onset of action of 3 mins.
Response to Arguments
Applicant's arguments filed 30 July 2025 have been fully considered but they are not persuasive.
The Applicant argues that there is no motivation to replace levocabastine with alcaftadine (Remarks, pgs. 6-7).
Applicant’s argument is not found persuasive. Since Ignar teaches an aqueous nasal composition comprising levocabastine, which is a H1 antagonist, one of ordinary skill in the art would have been led to use the teaching of alcaftadine as a H1 antagonist from Abelson.
The Applicant argues that one has to combine multiple disparate disclosures of Ignar (Remarks, pg. 7).
Applicant’s argument is not found persuasive. The Applicant is reminded that the teachings of KSR are actually an endorsement and expansion of the flexible and expansive approach to obviousness, which clearly invites continued reliance on such broad and flexible analyses concerning the utility of selecting alternative embodiments of components providing art-recognized utility, with no substantial change in the overall utility of a composition so formulated. See KSR International Co. v. Teleflex, Inc., 82 USPQ2d 1385, 1395-96 (U.S.2007) (“the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results”; “When a patent ‘simply arranges old elements with each performing the same function it had been known to perform’ and yields no more than one would expect from such an arrangement, the combination is obvious”; “a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions” exemplified by the holdings of cases such as Merck v. Biocraft.
The Applicant argues that Ignar does not teach an onset of action of 10 minutes or less (Remarks, pg. 8).
Applicant’s argument is not found persuasive. One of ordinary skill in the art would have been motivated to use Simons’ teaching that intranasal H1-antihistamine formulations have a rapid onset of action with ophthalmic formulations of 0.25% alcaftadine (Table C) having an onset of action of 0.05 h (3 mins) with a reasonable expectation of success. One of ordinary skill in the art would have been led to combine the teachings because Ignar teaches an eye drop or intranasal allergy formulation, Abelson teaches that alcaftadine is useful in treating nasal allergy symptoms, and Simons teaches that an ophthalmic solution of alcaftadine has an onset of action of 3 mins. The aqueous nasal composition in the instant claims is interpreted as intended use and is given minimal patentable weight. See MPEP 2111.02(II).
The Applicant argues that Abelson does not disclose or suggest the remaining components recited in claims 14-16 (Remarks, pg. 8).
Applicant’s argument is not found persuasive. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually. Where an applicant’s reply establishes that each of the applied references fails to teach a limitation and addresses the combined teachings and/or suggestions of the applied prior art, the reply as a whole does not attack the references individually as the phrase is used in Keller and reliance on Keller would not be appropriate. This is because “[T]he test for obviousness is what the combined teachings of the references would have suggested to [a PHOSITA].” In re Mouttet, 686 F.3d 1322, 1333, 103 USPQ2d 1219, 1226 (Fed. Cir. 2012).
Since Ignar teaches an aqueous nasal composition comprising levocabastine, which is a H1 antagonist, one of ordinary skill in the art would have been led to use the teaching of alcaftadine as a H1 antagonist from Abelson in claims 14-16. A person of ordinary skill in the art would have been motivated to use alcaftadine as an obvious alternative to levocabastine to address allergy-related conditions, as taught in Ignar.
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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/D.A.K./Examiner, Art Unit 1613
/BRIAN-YONG S KWON/ Supervisory Patent Examiner, Art Unit 1613