CLAIMS 1-16 AND 19-23 ARE PRESENTED FOR EXAMINATION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, has been examined under the first inventor to file provisions of the AIA .
Applicant’s response/amendment filed October 24, 2025 has been received and entered into the application.
Accordingly, the application papers have been amended as directed. Also, the double patenting rejection as set forth in the previous Office action dated October 24, 2025 has been overcome and is hereby withdrawn.
Claim Rejection - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 6-8, 10, 11 and 19-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Parasrampuria et al., (US 2008/0051385 A1, “Parasrampuria”, cited by the Examiner).
Parasrampuria teach pharmaceutically acceptable alcaftadine-containing, (e.g., [0015]), nasal compositions, e.g., drops, suspension and gels, ([0019]), and methods for administering such compositions for the treatment of nasal symptoms of ocular allergies including nasal inflammation, nasal congestion, rhinorrhea, nasal pruitis and sneezing, ([0018], where the composition is administered to the patient’s nostrils in the form of such nasal compositions, ([0019]).
The nasal compositions may contain various additives such as buffering agents, including a phosphate buffer, ([0023]), isotonizing agents, solubilizers, preservatives, viscosity-increasing agents, chelating agents, antioxidizing agents and pH regulators, (end of [0021]). Examples of such viscosity-increasing agents are methylcellulose, hydroxyethylcellulose, carboxymethylcellulose, hydroxypropylmethylcellulose, polyvinyl alcohol, chondroitin sulfate and salts thereof, ([0022]).
The alcaftadine may be present in a concentration range of from about 0.005% by weight to about 10% by weight, with from about 0.1% to about 0.35% being preferred, ([0026]). A preferred pH range of the composition is taught to be from about 6.5 to about 7.5, ([0023[). In a representative compositions shown in Table 1 at [0050], sodium chloride concentrations, (i.e., isotonicity agent), were 2.4, 2.3 and 2.1 mg/ml. In all three compositions, the preservative benzalkonium chloride was present at concentration of 0.2 mg/ml. and the chelator disodium edetate was present at a concentration of 1.1 mg/ml.
Accordingly, for the above reasons, the claims 1-4, 6-8, 10, 11 and 19-23 are deemed properly rejected.
Claim Rejection - 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.
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 1-16 and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Parasrampuria, cited above, for the reasons set forth above as applied to claims 1-4, 6-8, 10, 11 and 19-23, which reasons are here incorporated by reference.
The difference between the above and the claimed subject matter lies in that the particular viscosity values of present claims 5 and 12-16 are not taught and sodium monobasic phosphate is not taught as the buffering agent.
However, 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 because phosphate buffers in general are taught as is the present of viscosity-enhancing agents. The determination of the optimum phosphate buffer to employ as well as the particular viscosity, in the absence of evidence to the contrary, would have a been a matter within the purview of an ordinarily skill artisan and well within the scope and spirit of the invention disclosed as a whole by Parasrampuria.
None of the present claims are currently in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYMOND J HENLEY III whose telephone number is (571)272-0575. The examiner can normally be reached M-F 6-2:30pm EST.
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/RAYMOND J HENLEY III/Primary Examiner, Art Unit 1629 January 10, 2026