Application No. 16/908,426
`Response tc Non-Final Office Action Mailed March 28, 2023
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`AMENDMENTS TO THE CLAIMS
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`This listing of claims will replace all prior versions, and listings of claims in this
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`application. Applicant reserves the right to pursue any subject matter of any canceled claims in
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`this or any other appropriate patent application. Support for these claims is provided in the
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`remarks following the listing of claims.
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`Listing of the Claims
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`1.-30. (Canceled).
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`31. (Previously Presented) A kit comprising:
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`a. a container comprising a monotherapeutic pharmaceutical cornposition, the
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`monotherapeutic pharmaceutical composition comprising:
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`i.asole ophthalmic agent, wherein the sole ophthalmic agent is atropine or
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`atropine sulfate, and wherein the atropine or atropine sulfate is provided at about 0.01
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`me/g to about 0.5 mg/g:
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`ui. water:
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`iil. a buffer to provide a pH from about 4.8 to about 6.4;
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`iv. a tonicity adjusting agent: and
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`Vv. a viscosity agent, and
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`b. instructions for use.
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`32. (Previously Presented} The kit of claim 31, wherein the atropine or atropine sulfate is
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`present in the monotherapeutic pharmaceutical composition at a concentration of from about
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`0.01 mg/g to about 0.3 mg/g or from about 0.1 mg/g to about 0.2 mg/g.
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`33. (Previously Presented} The kit of claim 31, wherein the atropine or atropine sulfate is
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`present in the monotherapeutic pharmaceutical composition at a concentration of about 0.1 mg/g,
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`about 0.2 mg/g, about 0.25 mg/g, about 0.3 mg/g, about 0.4 mg/g, or about 0.5 ma/g.
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`34. (Currently Amended) The kit of claim 31, wherein the buffer comprises a borate, a
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`4t, a citrate buffering agent, an acetate borate-polyal complex, ¢
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`buffering agent, a carbonate buffering agent, an organic buffering agent, an amino acid buffering
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`agent, or a combination thereof.
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`Atty. Docket No.: 46682-701.317
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`
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`Application No. 16/908,426
`Response tc Non-Final Office Action Mailed March 28, 2023
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`35. (Currently Amended) The kit of claim 31, wherein the buffer comprisesacitrate
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`buffering agent, an acetate buffering agent,
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`phosphate, or a combination thereof.
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`36. (Canceled).
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`37, (Previously Presented) The kit of claim 31, wherein the tonicity adjusting agent
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`comprises a halide salt of a monovalent cation.
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`38. (Canceled).
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`39. (Previously Presented} The kit of claim 31, wherein the viscosity agent comprises
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`hydroxyethyl cellulose, hydroxypropy! cellulose, or hydroxypropylmethy!-cellulose CHPMC).
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`40. (Previously Presented} The kit of claim 31, wherein the monotherapeutic
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`pharmaceutical coniposition is substantially free of a preservative.
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`4]. (Previously Presented) The kit of claim 31, wherein the monotherapeutic
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`pharmaceutical composition comprises less than about 1%of a preservative.
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`42. (Previously Presented} The kit of claim 31, wherein the monotherapeutic
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`pharmaceutical composition further comprises a preservative.
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`43. (Previously Presented} The kit of claim 42, wherein a concentration of the
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`preservative is from about 0.0001%to about 1%.
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`44. (Previously Presented} The kit of claim 42, wherein the preservative is selected from
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`benzalkonium chloride, ceirrmonium, sodium perborate, stabilized oxychlore complex,
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`polyquaternium-1, chlorobutanol, edetate disodium, polyhexamethylene biguanide, or
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`combinations thereof.
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`45. (Previously Presented} The kit of claim 31, wherein the monotherapeutic
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`pharmaceutical composition is essentially free of procaine and benactyzine, or pharmaceutically
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`acceptable saits thereof.
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`46.-48. (Canceled).
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`49. (Previously Presented) The kit of claim 31, wherein the monotherapeutic
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`pharmaceutical composition is a solution.
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`50. (Previously Presented) The kit of claim 31, wherein the monotherapeutic
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`pharmaceutical composition is sterile.
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`Atty. Docket No.: 46682-701.317
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`
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`Application No. 16/908,426
`Response tc Non-Final Office Action Mailed March 28, 2023
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`51. (Previously Presented) The kit of claim 31, wherein the monotherapeutic
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`pharmaceutical composition further comprises a stabilizing agent.
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`52. (Previously Presented) The kit of claim S1, wherein the stabilizing agent is selected
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`from the group consisting of glycerol, methionine, monothioglycerol, ethylenediaminetetraacetic
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`acid (EDTA), ascorbic acid, polysorbate 80, polysorbate 20, arginine, heparin, dextran sulfate,
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`cyclodextrins, pentosan polysulfate, magnesium, zinc, and combinations thereof.
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`53. (Previously Presented) The kit of claim 52, wherein the stabilizing agentis EDTA.
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`whe
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`Atty. Docket No.: 46682-701.317
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