US. Serial No. 16/908,426
`Response to Fmal Office Action mailed September 9, 2022
`
`Attomey Docket No. 46682-7013 17
`
`AMENDMENTS TO THE CLAIMS
`
`This listing of claims replaces all prior versions andlisting of claims in the above-
`
`referenced patent application. The following amendments do not constitute an admission
`
`regarding the patentability of the amended subject matter and should not be so construed,
`
`Arnendments to the claims were made for purposes of more clearlystating the claimed subject
`
`matter and do not add newmatteror alter the scope of the claims. Deletions are denoted by
`
`[stricetheoueh| and additions are denoted by underline.
`
`Listing of the Claims
`
`1.-30. (Canceled).
`
`31. (Previously Presented) A kit comprising:
`
`a. a container comprising a monotherapeutic pharmaceutical composition, the
`
`monotherapeutic pharmaceutical composition comprising:
`
`i. a sole ophthalmic agent, wherein the sole ophthaimic agent is atropine or
`
`atropine sulfate, and wherein the atropine or atropine sulfate is provided at about 0.01
`
`mg/g to about 0.5 mg/s:
`
`i. water;
`
`iit. a buffer to provide a pH from about 4.8 to about 6.4;
`
`iv. atonicity adjusting agent; and
`
`V. a viscosity agent, and
`
`b. instructions for use.
`
`32. {Previously Presented) The kit of claim 31, wherein the atropine oratropine sulfate
`
`is present in the monotherapeutic pharmaceutical composition at a concentration of from about
`
`0.01 mg/g to about 0.3 mg/g or from about 0.1 mg/gto about 0.2 mg/g.
`
`33. (Previously Presented} The kit of claim 31, wherein the atropine or atropine sulfate
`
`is present in the monotherapeutic pharmaceutical composition at a concentration of about 0.1
`
`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.
`
`34. (Previously Presented) The kit of claim 31, wherein the buffer comprises a borate, a
`
`borate-polyol complex, a phosphate buffering agent, a citrate buffering agent, an acetate
`
`
`Response to Fmal Office Action mailed September 9, 2022
`
`Attomey Docket No. 46682-7013 17
`
`AMENDMENTS TO THE CLAIMS
`
`This listing of claims replaces all prior versions andlisting of claims in the above-
`
`referenced patent application. The following amendments do not constitute an admission
`
`regarding the patentability of the amended subject matter and should not be so construed,
`
`Arnendments to the claims were made for purposes of more clearlystating the claimed subject
`
`matter and do not add newmatteror alter the scope of the claims. Deletions are denoted by
`
`[stricetheoueh| and additions are denoted by underline.
`
`Listing of the Claims
`
`1.-30. (Canceled).
`
`31. (Previously Presented) A kit comprising:
`
`a. a container comprising a monotherapeutic pharmaceutical composition, the
`
`monotherapeutic pharmaceutical composition comprising:
`
`i. a sole ophthalmic agent, wherein the sole ophthaimic agent is atropine or
`
`atropine sulfate, and wherein the atropine or atropine sulfate is provided at about 0.01
`
`mg/g to about 0.5 mg/s:
`
`i. water;
`
`iit. a buffer to provide a pH from about 4.8 to about 6.4;
`
`iv. atonicity adjusting agent; and
`
`V. a viscosity agent, and
`
`b. instructions for use.
`
`32. {Previously Presented) The kit of claim 31, wherein the atropine oratropine sulfate
`
`is present in the monotherapeutic pharmaceutical composition at a concentration of from about
`
`0.01 mg/g to about 0.3 mg/g or from about 0.1 mg/gto about 0.2 mg/g.
`
`33. (Previously Presented} The kit of claim 31, wherein the atropine or atropine sulfate
`
`is present in the monotherapeutic pharmaceutical composition at a concentration of about 0.1
`
`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.
`
`34. (Previously Presented) The kit of claim 31, wherein the buffer comprises a borate, a
`
`borate-polyol complex, a phosphate buffering agent, a citrate buffering agent, an acetate
`
`
`
`US. Serial No. 16/908,426
`Response to Fmal Office Action mailed September 9, 2022
`
`Attomey Docket No. 46682-7013 17
`
`buffering agent, a carbonate buffering agent, an organic buffering agent, an amino acid buffering
`
`agent, or a combination thereof,
`
`35. (Previously Presented) The kit of claim 31, wherein the buffer comprises sodium
`
`dihydrogen phosphate, disodium hydrogen phosphate, or a combination thereof.
`
`36. (Canceled).
`
`37. {Previously Presented) The kit of claim 31, wherein the tonicity adjusting agent
`
`comprises a halide salt of a monovalent cation.
`
`38. (Canceled).
`
`39, (Previously Presented) The kit of claim 31, wherein the viscosity agent comprises
`
`hydroxyethy! cellulose, hydroxy propy! cellulose, or hydroxy propylmethyl-cellulose (HPMC).
`
`40. Previously Presented) The kit of claim 31, wherein the monotherapeutic
`
`pharmaceutical composition is substantially free of a preservative.
`
`4}. (Previously Presented) The kit of claim 31, wherein the monotherapeutic
`
`pharmaceutical composition comprises less than about 1% of a preservative.
`
`42. (Previously Presented) The kit of clairn 31, wherein the monotherapeutic
`
`pharmaceutical composition further comprises a preservative.
`
`43. (Previously Presented) The kit of claim 42, wherein a concentrationof the
`
`preservative is from about 0.000 1% to about 1%.
`
`44 (Previously Presented) The kit of claim 42, wherein the preservative is selected from
`
`benzalkonium chloride, cetrimonium, sodiumperborate, stabilized oxychloro complex,
`
`poly quaternium-1, chlorobutanol, edetate disodium, polyhexamethylene biguanide, or
`
`combinations thereof.
`
`45. (Previously Presented) The kitof claim 31, wherein the monotherapeutic
`
`pharmaceutical compasition is essentially free of procaine and benacty zine, or pharmaceutically
`
`acceptable salts thereof.
`
`46.-48. (Canceled).
`
`49. (Previously Presented) The kit of claim 31, wherein the monotherapeutic
`
`pharmaceutical composition is a solution.
`
`50. (Previously Presented) The kit of claim 31, wherein the monotherapeutic
`
`pharmaceutical composition is sterile.
`
`
`
`US. Serial No. 16/908,426
`Response to Fmal Office Action mailed September 9, 2022
`
`Attomey Docket No. 46682-7013 17
`
`51. (Previously Presented) The kit of claim 31, wherein the monotherapeutic
`
`pharmaceutical composition further comprises a stabilizing agent.
`
`52. (Previously Presented) The kit of claim 51, wherein the stabilizing agent is selected
`
`from the group consisting of glycerol, methionine, monothioglycerol, ethylenediaminetetraacetic
`
`acid (EDTA), ascorbic acid, polysorbate 80, polysorbate 20, arginine, heparin, dextran sulfate,
`
`cyclodextrins, pentosan polysulfate, magnesium, zinc, and combinations thereof.
`
`53. (Previously Presented} The kit of claim 52, wherein the stabilizing agent is EDTA.
`
`
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