DETAILED ACTION
This Office action is based on the amendments filed 7/15/26 for application 18/686241. Claims 1-5 and 7 are pending. Claim 1 is amended and claim 6 is cancelled.
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 . 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.
Withdrawn Rejections
The rejection of claims 1-5 under 35 U.S.C. 102(a)(1) as being anticipated by Leifheit (US Patent No. 4,743,395; cited in IDS of 8/12/25) is withdrawn in light of applicant’s amendments.
The rejection of claims 1-7 under 35 U.S.C. 103 as being unpatentable over Tien et al (WO 2011/127139; cited in IDS of 8/12/25) is withdrawn in light of applicant’s amendments.
Response to Arguments
Applicant argues that there is no teaching or suggestion in Tien to select a combination including the specific thickener in order to achieve the stability of chlorous acid, which serves as a radical generation source. Further, applicant argues that Tien does not teach or suggest the claimed viscosity of the composition.
However, applicant’s arguments filed 7/15/26 have been considered but are moot given the new rejections necessitated by applicant’s amendments below. The new rejection below relies upon a new secondary reference, Racic, which renders obvious the specific thickener, the amount of thickener and the viscosity of the composition.
New Rejections Necessitated by Applicant’s Amendments
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.
Claims 1-5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Tien et al (WO 2011/127139; cited in IDS of 8/12/25) in view of Racic et al (Journal of Drug Delivery Science and Technology, 49, 2019, pp. 50-57).
Regarding claim 1, Tien et al teach a preservative composition for protecting ophthalmic solutions from microbial attack comprising a combination of benzalkonium ion and an oxy-chlorite moiety (pg. 2, lines 10-17). More specifically, the oxy-chloro moiety is sodium chlorite and the benzalkonium ion is benzalkonium chloride (see claims 7 and 9). The compositions may be presented as solutions or suspensions in aqueous liquids (pg. 11, lines 29-30). Viscosity agents or thickeners, such as hydroxypropyl methylcellulose, can also be optionally added (pg. 13, lines 16-19). Therefore, Tien et al teach compositions comprising benzalkonium chloride (a radical generation catalyst), sodium chlorite (a radical generation source in the form of a chlorite) and water as well as compositions with a thickener like hydroxpropyl methylcellulose
However, Tien et al do not teach i) a thickener in an amount of the composition of 0.1 mass% or more and 20 mass% or less and ii) a viscosity of the composition at 20°C of 0.005 Pas to 600 Pas.
Racic et al discuss the incorporation of different mucoadhesive polymers including cellulose derivatives to modify conventional liquid ophthalmic formulations in order to prolong residence time at the ocular surface (abstract). More specifically, Racic disclose the preparation of an ophthalmic vehicle with 0.3% w/v hydoxypropyl methylcellulose (pg. 51, 2.2.1 Methods, Table 1) with a formulation having a viscosity at 20°C of 0.0777 Pas (Table 3; 3.2 Results and discussion).
Therefore, it would have been obvious to an artisan of ordinary skill before the effective filing date of the claimed invention to include cellulose derivatives like hydroxypropyl methycellulose in an amount of 0.3 mass% to achieve a viscosity at 20°C of 0.005 Pas to 600 Pas in the ophthalmic solutions of Tien et al. One would have been motivated to do so since Racic suggest adding different mucoadhesive polymers like hydroxypropyl methylcellulose at the instant amount can manipulate the viscosity of the composition within the instant range for conventional liquid ophthalmic formulations. Thus, it would have been obvious to add different amounts of thickeners to the ophthalmic solutions of Tien et al to achieve the desired viscosity of the composition and residence time at the ocular surface
Regarding claim 2, benzalkonium chloride would have a Lewis acidity of 0.4 eV or more according to the instant specification (paragraphs 0018-0046). Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Regarding claims 3-5, benzalkonium chloride is an ammonium salt that meets the chemical formulas recited in claims 3-5 (Formulas I-III), wherein R3 and R4 are each methyl, R11 is n-alkyl, X- is chlorine and R2 is benzyl.
Regarding claim 7, Tien et al teach compositions at an alkaline pH of especially about 6.5 to about 8 (pg. 13, lines 8-11).
Conclusion
Claims 1-5 and 7 are rejected. No claims 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 RACHAEL E BREDEFELD whose telephone number is (571)270-5237. The examiner can normally be reached 8:00-5:00 Monday-Friday.
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/RACHAEL E BREDEFELD/Supervisory Patent Examiner, Art Unit 3786
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