Dennis Mark MCDAID
`Application No. 18/182,797
`
`Amendments to the Claims
`
`This listing of claims will replace all prior versions, andlistings, of claims in the application.
`
`(Cancelled)
`
`15.
`
`(Currently Amended) A storage-stable omeprazole system, the system comprising (1) a first
`
`mixture
`
`comprising (a)
`
`a
`
`therapeutically effective
`
`amount of omeprazole, or
`
`a
`
`pharmaceutically acceptable salt thereof, (b) optionally a first desiccant, and (c) optionally a
`
`first buffering agent, wherein the first mixture contains a percentage of moisture of no more
`
`than about 2.5%; and (11) a second mixture comprising a second buffering agent, wherein the
`
`second mixture contains a percentage of moisture of no more than about 2.5%, wherein the
`
`first mixture and the second mixture are stored separately from each other and are mixed
`
`together on or just before constitution with water, and wherein the system contains no sodium
`
`from a sodium-containing buffering agent or the system contains sodium and potassium at a
`
`ratio of from about 1:2.6 to about 1:3.4 by weight.
`
`16.
`
`(Original) The storage-stable omeprazole system of claim 15, wherein the sodium and
`
`potassium are present at a ratio of about 1:3.2 by weight.
`
`Atty. Dkt. No. 4384.0010005
`
`

`

`Dennis Mark MCDAID
`Application No. 18/182,797
`
`17.
`
`(Currently Amended) The storage-stable omeprazole system of elaHas—ts—eréclaim 15,
`
`wherein the first mixture and/or the second mixture has a moisture content of about 0.5% to
`
`about 1.5%.
`
`18.
`
`(Currently Amended) The storage-stable omeprazole system of any-one-efelatmsts—/claim
`
`15, wherein the first mixture farthet+comprises (b) a first desiccant and/or the second mixture
`
`further comprises a second desiccant.
`
`19.
`
`(Cancelled)
`
`20.
`
`(Currently Amended) The storage-stable omeprazole system of any-one-efelatmsts—claim
`
`15, wherein the first mixture further-comprises(c) a first buffering agent.
`
`21.
`
`(Currently Amended) The storage-stable omeprazole system of any-one-efclatmsts5—20claim
`
`15, wherein the first mixture and the second mixture are each independently in a form of a
`
`powder, a pellet, a granule, a seed, a bead, a spheroid, a microsphere, or a mixture thereof.
`
`
`22.
`
`
`
`(Currently Amended) The storage-stable omeprazole system ofany-one-efclatms+t2tclaim
`
`15, wherein the omeprazole or the pharmaceutically acceptable salt thereof is micronized.
`
`Atty. Dkt. No. 4384.0010005
`
`

`

`
`23.
`
`
`
`(Currently Amended) The storage-stable omeprazole system ofany-ene-efclatmast2tclaim
`
`Dennis Mark MCDAID
`Application No. 18/182,797
`
`15, wherein the omeprazole or the pharmaceutically acceptable salt thereof is a mixture of
`
`micronized and non-micronized omeprazole or the pharmaceutically acceptable salt thereof.
`
`24-26,
`
`(Cancelled)
`
`27.
`
`(Currently Amended) The storage-stable omeprazole system of any-one-efclatms2026claim
`
`20, wherein the first buffering agent and the second buffering agent together provide a
`
`buffering capacity of about 2 mEq/ml dose of constituted powder with water.
`
`28.
`
`(Currently Amended) The storage-stable omeprazole system of any-one-efclatms+5-—27 claim
`
`27, wherein the first buffering agent and the second buffering agent are each independently
`
`selected from the group consisting of alkali metal or alkaline earth metal carbonates,
`
`bicarbonates, phosphates, citrates, borates, acetates, phthalates,
`
`tartrates, succinates, and
`
`mixtures thereof.
`
`
`29.
`
`
`
`(Currently Amended) The storage-stable omeprazole system ofany-one-efclatmst428claim
`
`28, wherein the first buffering agent and the second buffering agent are each independently
`
`selected from the group consisting of sodium bicarbonate, potassium bicarbonate, and a
`
`mixture thereof.
`
`Atty. Dkt. No. 4384.0010005
`
`

`

`Dennis Mark MCDAID
`Application No. 18/182,797
`
`30.
`
`(Currently Amended) The storage-stable omeprazole system of any-one-efclatms2029claim
`
`29, wherein thefirst buffering agent is sodium bicarbonate.
`
`31.
`
`(Currently Amended) The storage-stable omeprazole system of any-one-efelatmst5—29claim
`
`29, wherein the second buffering agent is a mixture of sodium bicarbonate and potassium
`
`bicarbonate.
`
`32.
`
`(Cancelled)
`
`33.
`
`(Currently Amended) The storage-stable omeprazole system of any-one-efeclatmsts—3tclaim
`
`29, wherein the first mixture and the second mixture together comprise sodium bicarbonate
`
`and potassium bicarbonate at a ratio of about 1:2.7 by weight.
`
`
`34.
`
`
`
`(Currently Amended) The storage-stable omeprazole system ofany-one-efclatmsts5-29claim
`
`29, wherein thefirst buffering agent and the second buffering agent are potassium bicarbonate.
`
`35.
`
`(Cancelled)
`
`Atty. Dkt. No. 4384.0010005
`
`

`

`Dennis Mark MCDAID
`Application No. 18/182,797
`
`36.
`
`(Currently Amended) The storage-stable omeprazole system of any—ef+the—precedinge
`
`elatmasclaim 15, wherein the storage-stable omeprazole system is provided in a drug delivery
`
`device suitable for multi-dose administration of omeprazole, or the pharmaceutically
`
`acceptable salt thereof.
`
`37.
`
`(Original) The storage-stable omeprazole system of claim 36, wherein the drug delivery
`
`device comprises two chambers.
`
`38.
`
`(Original) The storage-stable omeprazole system of claim 37, wherein the drug delivery
`
`device further comprises a meansfor releasing the contents of the first chamberinto the second
`
`chamber without removing the cap from the drug delivery device.
`
`39.
`
`(Currently Amended) The storage-stable omeprazole system of any-one-ofelaimst5-38claim
`
`36, wherein the storage-stable omeprazole system is provided in a container body comprising
`
`a cap, wherein (i) the container body contains the second mixture and has a container opening
`
`formed in an upper end thereof; (11) the cap comprises a cylindrical accommodation portion
`
`comprising the first mixture and a cap portion sealing an upper end of the accommodation
`
`portion, and wherein (i11) the cap is mounted in the container opening of the container body,
`
`wherein whenthe capis twisted, the first mixture is released into the container body.
`
`Atty. Dkt. No. 4384.0010005
`
`

`

`AO.
`
`(Cancelled)
`
`Dennis Mark MCDAID
`Application No. 18/182,797
`
`
`41.
`
`
`
`(Currently Amended) The storage-stable omeprazole system ofamy—one-ofthe-precedine
`
`elatmasclaim 15, wherein the-pewder omeprazole system remainsstable at 25°C / 60% relative
`
`humidity for at least 2 years.
`
`42-70.
`
`(Cancelled)
`
`71.
`
`(Currently Amended) An oral pharmaceutical suspension, comprising water[[,]] and a
`
`pharmaceutically effective amount of a_storage-stable omeprazole system of claim 15
`
`emeprazele—or-a-pharmaceuticallacceptable-saltthereef, dispersed in the water, and-ere-er
`
`more—buffering—agents; and wherein the suspension contains no sodium from a sodium-
`
`containing buffering agent or the suspension contains sodium and potassium ata ratio of from
`
`about 1:2.6 to about 1:3.4 by weight.
`
`72.
`
`(Cancelled)
`
`73.
`
`(Currently Amended) The oral pharmaceutical suspension of claim 71-er72, wherein about
`
`1 ml of the suspension contains from about 1 mg to about 10 mg of omeprazole, or the
`
`pharmaceutically acceptable salt thereof.
`
`Atty. Dkt. No. 4384.0010005
`
`

`

`Dennis Mark MCDAID
`Application No. 18/182,797
`
`74.
`
`(Cancelled)
`
`75.
`
`(Currently Amended) The oral pharmaceutical suspension of claim [[74]]73, wherein about 1
`
`ml of the suspension contains about 2 mg or about 4 mg of omeprazole, or
`
`the
`
`pharmaceutically acceptable salt thereof.
`
`
`76.
`
`
`
`(Currently Amended) The oral pharmaceutical suspension ofany-erne-ofclatms—t+—Aclaim
`
`71, wherein the first and second ene-or-mere-buffering agents together provide a buffering
`
`capacity of about 2 mEq per ml of the suspension.
`
`77-90.
`
`(Cancelled)
`
`
`91.
`
`
`
`(Currently Amended) The oral pharmaceutical suspension ofany-ene-ofclatms—71-90claim
`
`71, wherein the suspension is provided in a drug delivery device suitable for multi-dose
`
`administration of omeprazole.
`
`92.
`
`(Currently Amended) A method ofinhibiting gastric acid secretion, comprising administering
`
`to a subject in need thereof an effective amount of the oral pharmaceutical suspension of ay
`
`ene-ofclaims7-94claim 71.
`
`Atty. Dkt. No. 4384.0010005
`
`

`

`Dennis Mark MCDAID
`Application No. 18/182,797
`
`93.
`
`(Original) The method of claim 92, wherein the subject is a child.
`
`94-98.
`
`(Cancelled)
`
`99.
`
`(Currently Amended) A methodof preparing an oral pharmaceutical suspension, comprising
`
`combining(i)a first mixture comprising (a) a therapeutically effective amount of omeprazole,
`
`or a pharmaceutically acceptable salt thereof, (b) optionally a first desiccant, and (c) optionally
`
`a first buffering agent, wherein the first mixture contains a percentage of moisture of no more
`
`than about 2.5%; with (11)a second mixture comprising a second buffering agent, wherein the
`
`second mixture contains a percentage of moisture of no more than about 2.5%; to obtain a
`
`combined mixture, wherein the combined mixture contains no sodium from a sodium-
`
`containing buffering agent or the combined mixture contains sodium and potassium at a ratio
`
`of from about 1:2.6 to about 1:3.4 by weight; and adding water to the combined mixture.
`
`100-120.
`
`(Cancelled)
`
`121.
`
`(Currently Amended) A method ofinhibiting gastric acid secretion, comprising administering
`
`to a subject in need thereof an effective amount of an oral pharmaceutical suspension
`
`comprising water, a pharmaceutically effective amount of omeprazole, or a pharmaceutically
`
`acceptable salt thereof, dispersed in the water, and one or more buffering agents, wherein the
`
`Atty. Dkt. No. 4384.0010005
`
`

`

`-10-
`
`Dennis Mark MCDAID
`Application No. 18/182,797
`
`suspension contains no sodium from a sodium-containing buffering agent or the suspension
`
`contains sodium and potassium ata ratio of from about 1:2.6 to about 1:3.4 by weight; and
`
`
`
`
`
`wherein the oral pharmaceutical suspension is prepared as claimed inany-ere-efclaims-99-
`
`6 claim 99.
`
`
`122.
`
`
`
`(Currently Amended) The oral pharmaceutical suspension ofapy-erne-ofclatmas—1+90claim
`
`71, wherein the suspension remainsstable for at least one month at 2°C-8°C after constitution
`
`with water.
`
`123.
`
`(New) A method of administering an oral pharmaceutical suspension to a subject in need of
`
`inhibition of gastric acid secretion,
`
`said method comprising 1) preparing an oral
`
`pharmaceutical suspension, comprising combining (i) a first mixture comprising (a) a
`
`therapeutically effective amount of omeprazole, or a pharmaceutically acceptable salt thereof,
`
`(b) optionally a first desiccant, and (c) optionally a first buffering agent, wherein the first
`
`mixture contains a percentage of moisture of no more than about 2.5%; with (11) a second
`
`mixture comprising a second buffering agent, wherein the second mixture contains a
`
`percentage of moisture of no more than about 2.5%; to obtain a combined mixture, wherein
`
`the combined mixture contains no sodium from a sodium-containing buffering agent or the
`
`combined mixture contains sodium and potassium at a ratio of from about 1:2.6 to about 1:3.4
`
`Atty. Dkt. No. 4384.0010005
`
`

`

`-ll-
`
`Dennis Mark MCDAID
`Application No. 18/182,797
`
`by weight; and adding water to the combined mixture; and 2) administering to the subject in
`
`need thereof an effective amount of the oral pharmaceutical suspension.
`
`124.
`
`(New) The method of claim 123, wherein the subject is a child.
`
`Atty. Dkt. No. 4384.0010005
`
`

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