US. Serial No. 16/908,426
`Response to Fmal Office Action mailed September 9, 2022
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`Attomey Docket No. 46682-7013 17
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`AMENDMENTS TO THE CLAIMS
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`This listing of claims replaces all prior versions andlisting of claims in the above-
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`referenced patent application. The following amendments do not constitute an admission
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`regarding the patentability of the amended subject matter and should not be so construed,
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`Arnendments to the claims were made for purposes of more clearlystating the claimed subject
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`matter and do not add newmatteror alter the scope of the claims. Deletions are denoted by
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`[stricetheoueh| and additions are denoted by underline.
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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 composition, the
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`monotherapeutic pharmaceutical composition comprising:
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`i. a sole ophthalmic agent, wherein the sole ophthaimic 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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`mg/g to about 0.5 mg/s:
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`i. water;
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`iit. a buffer to provide a pH from about 4.8 to about 6.4;
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`iv. atonicity adjusting agent; and
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`V. 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 oratropine sulfate
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`is 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/gto about 0.2 mg/g.
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`33. (Previously Presented} The kit of claim 31, wherein the atropine or atropine sulfate
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`is present in the monotherapeutic pharmaceutical composition at a concentration of about 0.1
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`ma/g, about 0.2 mg/g, about 0.25 mg/g, about 0.3 mg/g, about 0.4 me/g, or about 0.5 mg/g.
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`34. (Previously Presented) The kit of claim 31, wherein the buffer comprises a borate, a
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`borate-polyol complex, a phosphate buffering agent, a citrate buffering agent, an acetate
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`US. Serial No. 16/908,426
`Response to Fmal Office Action mailed September 9, 2022
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`Attomey Docket No. 46682-7013 17
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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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`35. (Previously Presented) The kit of claim 31, wherein the buffer comprises sodium
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`dihydrogen phosphate, disodium hydrogen 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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`hydroxyethy! cellulose, hydroxy propy! cellulose, or hydroxy propylmethyl-cellulose (HPMC).
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`40. Previously Presented) The kit of claim 31, wherein the monotherapeutic
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`pharmaceutical composition 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 clairn 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 concentrationof the
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`preservative is from about 0.000 1% 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, cetrimonium, sodiumperborate, stabilized oxychloro complex,
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`poly quaternium-1, chlorobutanol, edetate disodium, polyhexamethylene biguanide, or
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`combinations thereof.
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`45. (Previously Presented) The kitof claim 31, wherein the monotherapeutic
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`pharmaceutical compasition is essentially free of procaine and benacty zine, or pharmaceutically
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`acceptable salts 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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`US. Serial No. 16/908,426
`Response to Fmal Office Action mailed September 9, 2022
`
`Attomey Docket No. 46682-7013 17
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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 51, 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 agent is EDTA.
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