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
`
`
`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
`
`
Accessing this document will incur an additional charge of $.
After purchase, you can access this document again without charge.
Accept $ Charge
Still Working On It
This document is taking longer than usual to download. This can happen if we need to contact the court directly to obtain the document and their servers are running slowly.
Give it another minute or two to complete, and then try the refresh button.
A few More Minutes ... Still Working
It can take up to 5 minutes for us to download a document if the court servers are running slowly.
Thank you for your continued patience.
This document could not be displayed.
We could not find this document within its docket. Please go back to the docket page and check the link. If that does not work, go back to the docket and refresh it to pull the newest information.
Your account does not support viewing this document.
You need a Paid Account to view this document. Click here to change your account type.
Your account does not support viewing this document.
Set your membership
status to view this document.
With a Docket Alarm membership, you'll
get a whole lot more, including:
- Up-to-date information for this case.
- Email alerts whenever there is an update.
- Full text search for other cases.
- Get email alerts whenever a new case matches your search.
One Moment Please
The filing “” is large (MB) and is being downloaded.
Please refresh this page in a few minutes to see if the filing has been downloaded. The filing will also be emailed to you when the download completes.
Your document is on its way!
If you do not receive the document in five minutes, contact support at support@docketalarm.com.
Sealed Document
We are unable to display this document, it may be under a court ordered seal.
If you have proper credentials to access the file, you may proceed directly to the court's system using your government issued username and password.
Access Government Site
