Application No. 16/908,426
`Response tc Non-Final Office Action Mailed March 28, 2023
`
`AMENDMENTS TO THE CLAIMS
`
`This listing of claims will replace all prior versions, and listings of claims in this
`
`application. Applicant reserves the right to pursue any subject matter of any canceled claims in
`
`this or any other appropriate patent application. Support for these claims is provided in the
`
`remarks following the listing of claims.
`
`Listing of the Claims
`
`1.-30. (Canceled).
`
`31. (Previously Presented) A kit comprising:
`
`a. a container comprising a monotherapeutic pharmaceutical cornposition, the
`
`monotherapeutic pharmaceutical composition comprising:
`
`i.asole ophthalmic agent, wherein the sole ophthalmic agent is atropine or
`
`atropine sulfate, and wherein the atropine or atropine sulfate is provided at about 0.01
`
`me/g to about 0.5 mg/g:
`
`ui. water:
`
`iil. a buffer to provide a pH from about 4.8 to about 6.4;
`
`iv. a tonicity adjusting agent: and
`
`Vv. a viscosity agent, and
`
`b. instructions for use.
`
`32. (Previously Presented} The kit of claim 31, wherein the atropine or atropine 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/g to 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 mg/g,
`
`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.
`
`34. (Currently Amended) The kit of claim 31, wherein the buffer comprises a borate, a
`
`4t, a citrate buffering agent, an acetate borate-polyal complex, ¢
`
`buffering agent, a carbonate buffering agent, an organic buffering agent, an amino acid buffering
`
`agent, or a combination thereof.
`
`Atty. Docket No.: 46682-701.317
`
`
`Response tc Non-Final Office Action Mailed March 28, 2023
`
`AMENDMENTS TO THE CLAIMS
`
`This listing of claims will replace all prior versions, and listings of claims in this
`
`application. Applicant reserves the right to pursue any subject matter of any canceled claims in
`
`this or any other appropriate patent application. Support for these claims is provided in the
`
`remarks following the listing of claims.
`
`Listing of the Claims
`
`1.-30. (Canceled).
`
`31. (Previously Presented) A kit comprising:
`
`a. a container comprising a monotherapeutic pharmaceutical cornposition, the
`
`monotherapeutic pharmaceutical composition comprising:
`
`i.asole ophthalmic agent, wherein the sole ophthalmic agent is atropine or
`
`atropine sulfate, and wherein the atropine or atropine sulfate is provided at about 0.01
`
`me/g to about 0.5 mg/g:
`
`ui. water:
`
`iil. a buffer to provide a pH from about 4.8 to about 6.4;
`
`iv. a tonicity adjusting agent: and
`
`Vv. a viscosity agent, and
`
`b. instructions for use.
`
`32. (Previously Presented} The kit of claim 31, wherein the atropine or atropine 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/g to 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 mg/g,
`
`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.
`
`34. (Currently Amended) The kit of claim 31, wherein the buffer comprises a borate, a
`
`4t, a citrate buffering agent, an acetate borate-polyal complex, ¢
`
`buffering agent, a carbonate buffering agent, an organic buffering agent, an amino acid buffering
`
`agent, or a combination thereof.
`
`Atty. Docket No.: 46682-701.317
`
`
`
`Application No. 16/908,426
`Response tc Non-Final Office Action Mailed March 28, 2023
`
`35. (Currently Amended) The kit of claim 31, wherein the buffer comprisesacitrate
`
`
`buffering agent, an acetate buffering agent,
`
`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
`
`hydroxyethyl cellulose, hydroxypropy! cellulose, or hydroxypropylmethy!-cellulose CHPMC).
`
`40. (Previously Presented} The kit of claim 31, wherein the monotherapeutic
`
`pharmaceutical coniposition 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 claim 31, wherein the monotherapeutic
`
`pharmaceutical composition further comprises a preservative.
`
`43. (Previously Presented} The kit of claim 42, wherein a concentration of the
`
`preservative is from about 0.0001%to about 1%.
`
`44. (Previously Presented} The kit of claim 42, wherein the preservative is selected from
`
`benzalkonium chloride, ceirrmonium, sodium perborate, stabilized oxychlore complex,
`
`polyquaternium-1, chlorobutanol, edetate disodium, polyhexamethylene biguanide, or
`
`combinations thereof.
`
`45. (Previously Presented} The kit of claim 31, wherein the monotherapeutic
`
`pharmaceutical composition is essentially free of procaine and benactyzine, or pharmaceutically
`
`acceptable saits 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.
`
`Atty. Docket No.: 46682-701.317
`
`
`
`Application No. 16/908,426
`Response tc Non-Final Office Action Mailed March 28, 2023
`
`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 S1, 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 agentis EDTA.
`
`whe
`
`Atty. Docket No.: 46682-701.317
`
`
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