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 arguments filed 14 November 2025 and 17 February 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the
complete set presently being applied to the instant application. In the Applicant’s responses, filed
14 November 2025 and 17 February 2026, it is noted that claim 30 has been newly added. Support for the new claim can be found in para. 61 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), benzalkonium 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).
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. Generally, it is prima facie obvious to combine or substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
Claim(s) 14-16, 29, 30 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), Simons et al. (Histamine and H1-antihistamines: Celebrating a century of progress, J Allergy Clin Immunol, 2011), and Dhuppad et al. (US 2015/0079178 A1).
In regards to claim(s)14-16, 29, Ignar, Abelson, and Simons, as applied supra, is herein applied in its entirety for its teachings of a nasal spray comprising alcaftadine.
Ignar does not teach a viscosity of about 131.42 to about 195.76 cPs in claim 30.
Dhuppad teaches an aqueous nasal composition (abs, para. 28) to treat allergic rhinitis (para. 110). The composition may comprise microcrystalline cellulose and sodium carboxymethyl cellulose (para. 38), which is interpreted as a viscosity or suspending agent (instant specification, para. 59). The viscosity of the composition may range from 20-150 cPs (para. 26).
Since Ignar does not teach a viscosity of about 131.42 to about 195.76 cPs in claim 30, one of ordinary skill in the art would have been motivated to use Dhuppad’s teaching of a nasal composition with a viscosity of 20-150 cPs 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 and Dhuppad teaches a nasal spray composition to treat allergies comprising microcrystalline cellulose and sodium carboxymethyl cellulose, which are interpreted as viscosity or suspending agents. Since Ignar is silent on a specific viscosity range for their nasal composition to treat allergies, a skilled artisan would have been led to Dhuppad’s viscosity range for their nasal composition to treat allergic rhinitis. Generally, it is prima facie obvious to combine or substitute one equivalent component or process for another, each of which is taught by the prior art to be useful for the same purpose (see MPEP 2144.06).
Response to Arguments
Applicant's arguments filed 14 November 2025 have been fully considered but they are not persuasive.
The Applicant argues that a person of ordinary skill in the art would have had no motivation to replace levocabastine with alcaftadine (Remarks, pgs. 2-3).
Applicant’s argument is not found persuasive. Ignar teaches formulations comprising levocabastine, with specific emphasis on H1 antagonists (abs). Since Ignar teaches an aqueous intranasal composition comprising levocabastine, which is a H1 antagonist, one of ordinary skill in the art would have been reasonably led to use the teaching of alcaftadine as another H1 antagonist from Abelson’s teaching 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. Furthermore, Abeson teaches a link between antihistamine drugs typically used to treat eye allergies and their positive results in treating nasal allergy symptoms. Therefore, a skilled artisan would have been led to combine the teachings with a reasonable expectation of success.
The Applicant argues that the instant invention is towards a nasally administered drug, and Abelson only allegedly teaches allergy treatment with ophthalmically administered drugs (Remarks, pg. 3).
Applicant’s argument is not found persuasive. The instant claims recite an aqueous nasal pharmaceutical composition comprising alcaftadine. Applicant’s assertion of “nasal administration” is considered intended use and is given minimal patentable weight (see MPEP 2111.02(II)).
The Applicant argues that Simons allegedly teaches an onset of action of alcaftadine through ophthalmic formulations, whereas the instant invention is for intranasal administration (Remarks, pg. 3).
Applicant’s argument is not found persuasive. The instant claims recite an aqueous nasal pharmaceutical composition comprising alcaftadine. Applicant’s assertion of nasal administration is considered intended use and is given minimal patentable weight (see MPEP 2111.02(II)). Furthermore, since Ignar does not specifically teach an onset of action for alcaftadine, a skilled artisan would have been motivated to use Simons’ teaching that intranasal H1-antihistamine formulations have a rapid onset of action. Specifically, the ophthalmic formulations of 0.25% alcaftadine (Table C) has an onset of action of 0.05 hours (3 mins). One of ordinary skill in the art would have therefore 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.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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