IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`
`
`First Named Inventor: Desai
`
`
`
`Application No.: 10/616, 709
`
`
`
`Filed: 10 Jul 2003
`
`Art Unit: 1654
`
`
`
`Examiner: Roy R. Teller
`
`
`
`Confirmation No.: 2620
`
`Title: Propofol Formulations With Non­
`
`
`
`
`
`Reactive Container Closures
`
`
`
`Attorney Docket No.: FKA01 005 US
`
`Mail Stop Amendment
`
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22 31 3-1450
`
`RESPONSE UNDER 37 CFR 1.111
`
`Dear Sir:
`
`
`
`This communication responds to the Office Action mailed on December 10, 2012.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Applicants respectfully request that the Examiner reconsider the rejections in view of the
`
`
`
`
`
`
`
`
`
`
`
`
`
`following amendments and remarks.
`
`
`
`Amendments to the Claims are reflected in the listing of cl.aims which begins on
`
`
`
`
`
`
`
`
`
`page 2.
`
`
`
`Remarks begin on page 15.
`
`
`
`Bass and Spangenberg
`v.
`
`Fresenius Kabi USA, LLC
`U.S. Patent No. 8,476,010
`Exhibit 1020
`
`Exh. 1020
`
`

`
`Serial No. 10/616,70 9
`
`IN THE CLAIMS:
`
`PATENT
`Docket No. FKA01 005 US
`
`In accord with Rule§ 1.121 , a complete claim listing is presented below, including
`
`appropriate status identifiers. The changes in amended claims are shown by strikethrough
`
`or double brackets for deleted material, and by underlining for added material.
`
`1.
`
`(Currently Amended) A sterile pharmaceutical composition of propofol in a
`
`container, comprising:
`
`a container which includes a closure and a composition in the container, and
`
`the composition in the container comprising from 0.5% to 10% by weight propofol
`
`and less than 1 0% by weight solvent for propofol,
`
`where when the composition in the container sealed with the closure is agitated at a
`
`frequency of 300-400 cycles/minute for 16 hours at room temperature, the composition
`
`maintains a propofol concentration (w/v) measured by HPLC that is at least 93% ofthe
`
`starting concentration (w/v) of the propofoi.L
`
`where the closure is selected from the group consisting of
`
`siliconized bromobutyl rubber,
`
`a non-rubber selected from the group consisting of metal, plastics, and mixtures
`
`thereof, and
`
`siliconized chlorobutyl rubber.
`
`2.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 1, the composition further comprising an aqueous phase and protein.
`
`3.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 2, wherein the protein is albumin.
`
`4.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 3, wherein the albumin is present in an amount of from about 0.01% to
`
`about 5% by weight of the composition.
`
`2
`
`Exh. 1020
`
`

`
`Serial No. 10/616,70 9
`
`PATENT
`Docket No. FKA01 005 US
`
`5.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 2, wherein the aqueous phase comprises water for injection and a pH
`
`modifier.
`
`6.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 2, wherein the composition comprises a tonicity agent.
`
`7.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 3, wherein the pH modifier is sodium hydroxide.
`
`8.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 6, wherein the tonicity agent is glycerin.
`
`9.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 2, wherein the composition further comprises a surfactant.
`
`10.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 1, wherein the composition further comprises a solvent for propofol.
`
`11.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 10 wherein the solvent is a water-immiscible solvent.
`
`12.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 11, wherein the water-immiscible solvent is selected from the group
`
`consisting of soybean, safflower, cottonseed, corn, coconut, sunflower, arachis, castor
`
`sesame, orange, limonene or olive oil, an ester of a medium or long-chain fatty acid, a
`
`chemically modified or manufactured palmitate, glyceral ester or polyoxyl, hydrogenated
`
`castor oil, a marine oil, fractionated oils, and mixtures thereof.
`
`13.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 12, wherein the water-immiscible solvent is soybean oil.
`
`3
`
`Exh. 1020
`
`

`
`Serial No. 10/616,70 9
`
`PATENT
`Docket No. FKA01 005 US
`
`14.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 10, wherein the solvent is selected from the group consisting of
`
`chloroform, methylene chloride, ethyl acetate, ethanol, tetrahydrofuran, dioxane,
`
`acetonitrile, acetone, dimethyl sulfoxide, dimethyl forrnamide, methyl pyrrolidinone,
`
`C1-C20 alcohols, C2-C20 esters, C3-C20 ketones, polyethylene glycols, aliphatic
`
`hydrocarbons, aromatic hydrocarbons, halogenated hydrocarbons and combinations
`
`thereof.
`
`15.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 9, wherein the surfactant is selected from the group consisting of
`
`phosphatides, synthetic phospho! ipids, natural phospho! ipids, lecithins, ethoxylated ethers
`
`and esters, tocopherol polyethylene glycol stearate, polypropylene-polyethylene block co(cid:173)
`
`polymers, polyvinyl pyrrolidone, and polyvinylalcohol and combinations thereof.
`
`16.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 15, wherein the surfactant is selected from the group consisting of egg
`
`phosphatides, soya phosphatides, egg lecithins, soya lecithins, and combinations thereof.
`
`1 7.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 16, wherein the surfactant is egg lecithin.
`
`18.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 1, wherein the closure is coated with a material inert to propofol.
`
`19.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 1, wherein the closure consists essentially of a material that is itself inert
`
`to propofol.
`
`20.
`
`(Cancelled)
`
`4
`
`Exh. 1020
`
`

`
`Serial No. 10/616,70 9
`
`PATENT
`Docket No. FKA01 005 US
`
`21.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 19, wherein the closure material is a non-rubber selected from the
`
`group consisting of metal, plastics, and mixtures thereof.
`
`22-23. (Cancelled)
`
`24.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 1, wherein the closure comprises siliconized bromobutyl rubber.
`
`25.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 1, wherein the closure comprises a non-rubber selected from the group
`
`consisting of metal, plastics, and mixtures thereof.
`
`26.
`
`(Cancelled)
`
`27.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 1, wherein the closure comprises siliconized chlorobutyl rubber.
`
`28.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 1, wherein the composition comprises soybean oil in an amount of
`
`from about 0.5% to about 6% by weight of the composition, egg lecithin in an amount of
`
`from about 0.1% to about 5% by weight of the composition and human serum albumin in
`
`an amount of from about 0.1% to about 5% of the composition.
`
`29.
`
`(Currently Amended) A sterile pharmaceutical composition of propofol in a
`
`container, comprising:
`
`a container which includes a closure and an oil-in-water emulsion for parenteral
`
`administration of propofol in the container,
`
`the emulsion comprising an oil phase comprising propofol and a solvent for
`
`propofol, and an aqueous phase comprising water for injection,
`
`the emulsion comprising less than 10% by weight of the solvent,
`
`5
`
`Exh. 1020
`
`

`
`Serial No. 10/616,70 9
`
`PATENT
`Docket No. FKA01 005 US
`
`the emulsion further comprising a stabilizing layer for the oil phase, the stabilizing
`
`layer comprising a surfactant and a protein;
`
`where when the emulsion in the container sealed with the closure is agitated at a
`
`frequency of 300-400 cycles/minute for 16 hours at room temperature, the emulsion
`
`maintains a propofol concentration (w/v) measured by HPLC that is at least 93% ofthe
`
`starting concentration (w/v) of the propofol.£.
`
`where the closure is selected from the group consisting of
`
`siliconized bromobutyl rubber,
`
`a non-rubber selected from the group consisting of metal, plastics, and mixtures
`
`thereof, and
`
`siliconized chlorobutyl rubber.
`
`30.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 29, wherein the protein is selected from the group consisting of
`
`albumins, globulins, immunoglobulins, lipoproteins, caseins, insu I ins, hemoglobins,
`
`lysozymes, al pha-2 -macroglobu I in, fibronecti ns, vitronecti ns, fibrinogens, I i pases, peptides,
`
`enzymes, antibodies and combinations thereof.
`
`31.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 29, wherein the surfactant is selected from the group consisting of
`
`phosphatides, synthetic phospho I ipids, natural phospho! ipids, lecithins, ethoxylated ethers
`
`and esters, tocopherol polyethylene glycol stearate, polypropylene-polyethylene block co(cid:173)
`
`polymers, polyvinyl pyrrolidone, and polyvinylalcohol.
`
`32.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 29, wherein the oil phase is propofol neat.
`
`33.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 29, wherein the surfactant is lecithin and the protein is albumin.
`
`6
`
`Exh. 1020
`
`

`
`Serial No. 10/616,70 9
`
`PATENT
`Docket No. FKA01 005 US
`
`34.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 29, wherein the oil phase includes a solvent, and wherein the solvent is
`
`selected from the group consisting of soybean, safflower, cottonseed, corn, coconut,
`
`sunflower, arachis, castor sesame, orange, limonene or olive oil, an ester of a medium or
`
`long-chain fatty acid, a chemically modified or manufactured palmitate, glyceral ester or
`
`polyoxyl, hydrogenated castor oil, a marine oil, fractionated oils, and mixtures thereof,
`
`chloroform, methylene chloride, ethyl acetate, ethanol, tetrahydrofuran, dioxane,
`
`acetonitrile, acetone, dimethy l sulfoxide, dimethyl formamide, methyl pyrrolidinone,
`
`C1-C20 alcohols, C2-C20 esters, C3-C20 ketones, polyethylene glycols, aliphatic
`
`hydrocarbons, aromatic hydrocarbons, halogenated hydrocarbons and combinations
`
`thereof.
`
`35.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 34, wherein the solvent is soybean oil.
`
`36.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 35, wherein the soybean oil is present in an amount of from about
`
`0.5% to about 6% by weight of the emulsion.
`
`37.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 33, wherein the egg lecithin is present in the emulsion in an amount of
`
`from about 0.1 % to about 5% by weight of the emulsion and the albumin is present in the
`
`emulsion in an amount of from about 0.01 % to about 5% by weight of the emulsion.
`
`38.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 37, wherein the oil phase incl udes soybean oil.
`
`39.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 38, wherein the soybean oil is present in an amount of from about
`
`0.5% to about 6% by weight of the emulsion.
`
`7
`
`Exh. 1020
`
`

`
`Serial No. 10/616,70 9
`
`PATENT
`Docket No. FKA01 005 US
`
`40.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 38, wherein the soybean oil is present in the emulsion in an amount of
`
`from about 0.5% to about 3% by weight ofthe emulsion.
`
`41.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 31, comprising:
`
`a) about 1% to 2% by weight of propofol,
`
`b) 3-6% by weight of soybean oil,
`
`c) 0.2-1.0% by weight of egg lecith in,
`
`d) about 2.25% by weight of glycerin,
`
`e) sodium hydroxide,
`
`f) water to 1 00%, and
`
`g) pH between 5.0-8.5.
`
`42.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 29, wherein the closure is treated with a material inert to propofol.
`
`43.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 29, wherein the closure consists essentially of a material that is itself
`
`inert to propofol.
`
`44.
`
`(Cancelled)
`
`45.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 43, wherein the closure material is a non-rubber selected from the
`
`group consisting of metal, plastics, and mixtures thereof.
`
`46-47. (Cancelled)
`
`48.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 29, wherein the closure comprises siliconized bromobutyl rubber.
`
`8
`
`Exh. 1020
`
`

`
`Serial No. 10/616,70 9
`
`PATENT
`Docket No. FKA01 005 US
`
`49.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 29, wherein the closure comprises a non-rubber selected from the
`
`group consisting of metal, plastics, and mixtures thereof.
`
`50.
`
`(Cancelled)
`
`51.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 29, wherein the closure comprises si liconized chlorobutyl rubber.
`
`52.
`
`(Currently Amended) A sterile, injectable pharmaceutical composition in a
`
`contai ner, comprising:
`
`a container which includes a closure and a composition in the container, the
`
`composition comprising
`
`a) microdroplets having a mean size offrom about 20 nanometers to about
`
`1000 nanometers, the microdroplets comprising a sphere of propofol surrounded by a
`
`stabilizing layer comprising a phospholipid and devoid of oils capable of supporting
`
`bacterial growth; and
`
`b) a pharmaceutically acceptable injectable carrier;
`
`where when the composition in the container sealed with the closure is agitated at a
`
`frequency of 300-400 cycles/minute for 16 hours at room temperature, the composition
`
`maintains a propofol concentration (w/v) measured by HPLC that is at least 93% of the
`
`starting concentration (w/v) of the propofolL
`
`where the closure is selected from the group consisting of
`
`siliconized bromobutyl rubber,
`
`a non-rubber selected from the group consisti ng of metal, plastics, and mixtures
`
`thereof, and
`
`siliconized chlorobutyl rubber.
`
`53.
`
`(Previously presented) The sterile, injectable pharmaceutical composition in a
`
`contai ner according to claim 52, w herein the composition further comprises albumin.
`
`9
`
`Exh. 1020
`
`

`
`Serial No. 10/616,70 9
`
`PATENT
`Docket No. FKA01 005 US
`
`54.
`
`(Previously presented) The sterile, injectable pharmaceutical composition in a
`
`container according to claim 52, w herein the stabilizing layer includes albumin.
`
`55.
`
`(Previously presented) The sterile, injectable pharmaceutical composition in a
`
`container according to claim 52, wherein the closure is coated with a material inert to
`
`propofol.
`
`56.
`
`(Previously presented) The sterile, injectable pharmaceutical composition in a
`
`container according to claim 52, w herein the closure consists essentially of a material that
`
`is itself inert to propofol.
`
`57.
`
`(Cancelled)
`
`58.
`
`(Previously presented) The sterile, injectable pharmaceutical composition in a
`
`container according to claim 56, w herein the closure material is a non-rubber selected
`
`from the group consisting of metal, plastics, and mixtures thereof.
`
`59-60. (Cancelled)
`
`61.
`
`(Previously presented) The sterile, injectable pharmaceutical composition in a
`
`container according to claim 52, w herein the closure comprises siliconized bromobutyl
`
`rubber.
`
`62.
`
`(Previously presented) The sterile, injectable pharmaceutical composition in a
`
`container according to claim 52, w herein the closure comprises a non-rubber selected from
`
`the group consisting of metal, plastics and mixtures thereof.
`
`63.
`
`(Cancelled)
`
`10
`
`Exh. 1020
`
`

`
`Serial No. 10/616,70 9
`
`PATENT
`Docket No. FKA01 005 US
`
`64.
`
`(Previously presented) The sterile, injectable pharmaceutical composition in a
`
`container according to claim 52, w herein the closure comprises silicon ized chlorobutyl
`
`rubber.
`
`65-67. (Cancelled)
`
`68.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 1, wherein when the composition is stored in the container sealed with
`
`the closure for at least two months, the composition maintains a propofol concentration
`
`(w/v) measured by HPLC that is at least about 95% of the starting concentration (w/v) of the
`
`propofol.
`
`69.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 68, wherein the composition is stored in the container sealed with the
`
`closure in a controlled environment of about 40°C and about 75% relative humidity for at
`
`least two months.
`
`70.
`
`(Cancelled)
`
`71.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 1, where when the composition in the container sealed with the closure
`
`is agitated at a frequency of 300-400 cycles/minute for 16 hours at room temperature, the
`
`composition maintains a propofol concentration (w/v) measured by HPLC that is at least
`
`95% of the starting concentration (w/v) of the propofol.
`
`72.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 1, where when the composition in the container sealed with the closure
`
`is agitated at a frequency of 300-400 cycles/minute for 16 hours at room temperature, the
`
`composition maintains a propofol concentration (w/v) measured by HPLC that is at least
`
`97% of the starting concentration (w/v) of the propofol.
`
`11
`
`Exh. 1020
`
`

`
`Serial No. 10/616,70 9
`
`PATENT
`Docket No. FKA01 005 US
`
`73.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 1, where when the composition in the container sealed with the closure
`
`is agitated at a frequency of 300-400 cycles/minute for 16 hours at room temperature, the
`
`composition maintains a propofol concentration (w/v) measured by HPLC that is at least
`
`99% of the starting concentration (w/v) of the propofol.
`
`74.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 29, where when the emulsion in the container sealed with the closure
`
`is agitated at a frequency of 300-400 cycles/minute for 16 hours at room temperature, the
`
`emulsion maintains a propofol concentration (w/v) measured by HPLC that is at least 95 %
`
`of the starting concentration (w/v) of the propofol.
`
`75.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 29, where when the emulsion in the container sealed with the closure
`
`is agitated at a frequency of 300-400 cycles/minute for 16 hours at room temperature, the
`
`emulsion maintains a propofol concentration (w/v) measured by HPLC that is at least 97%
`
`of the starting concentration (w/v) of the propofol.
`
`76.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 29, where when the emulsion in the container sealed with the closure
`
`is agitated at a frequency of 300-400 cycles/minute for 16 hours at room temperature, the
`
`emulsion maintains a propofol concentration (w/v) measured by HPLC that is at least 99%
`
`of the starting concentration (w/v) of the propofol.
`
`77.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 29, where when the emulsion is stored in the container sealed with the
`
`closure for at least two months, the emulsion maintains a propofol concentration (w/v)
`
`measured by HPLC that is at least 95% of the starting concentration (w/v) of the propofol.
`
`78.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 29, where when the emulsion is stored in the container sealed with the
`
`12
`
`Exh. 1020
`
`

`
`Serial No. 10/616,70 9
`
`PATENT
`Docket No. FKA01 005 US
`
`closure in a controlled environment of about 40°( and about 75% relative humidity for at
`
`least two months, the emulsion maintains a propofol concentration (w/v) measured by
`
`HPLC that is at least 95% of the starting concentration (w/v) ofthe propofol.
`
`79.
`
`(Previously presented) The sterile, injectable pharmaceutical composition in a
`
`container according to claim 52, w here when the composition in the container sealed w ith
`
`the closure is agitated at a frequency of 300-400 cycles/minute for 16 hours at room
`
`temperature, the composition maintains a propofol concentration (w/v) measured by HPLC
`
`that is at least 95% of the starting concentration (w/v) of the propofol.
`
`80.
`
`(Previously presented) The sterile, injectable pharmaceutical composition in a
`
`container according to claim 52, w here when the composition in the container sealed with
`
`the closure is agitated at a frequency of 300-400 cycles/minute for 16 hours at room
`
`temperature, the composition maintains a propofol concentration (w/v) measured by HPLC
`
`that is at least 97% of the starting concentration (w/v) of the propofol.
`
`81.
`
`(Previously presented) The sterile, injectable pharmaceutical composition in a
`
`container according to claim 52, w here when the composition in the container sealed w ith
`
`the closure is agitated at a frequency of 300-400 cycles/minute for 16 hours at room
`
`temperature, the composition maintains a propofol concentration (w/v) measured by HPLC
`
`that is at least 99% of the starting concentration (w/v) of the propofol.
`
`82.
`
`(Previously presented) The sterile, injectable pharmaceutical composition in a
`
`contai ner according to claim 52, where when the composition is stored in the container
`
`sealed with the closure for at least two months, the composition maintains a propofol
`
`concentration (w/v) measured by HPLC that is at least 95% of the starting concentration
`
`(w/v) of the propofol.
`
`83.
`
`(Previously presented) The sterile, injectable pharmaceutical composition in a
`
`contai ner according to claim 52, w here when the composition is stored in the container
`
`sealed with the closure in a controlled environment of about 40°( and about 7 5% relative
`
`13
`
`Exh. 1020
`
`

`
`Serial No. 10/616,70 9
`
`PATENT
`Docket No. FKA01 005 US
`
`humidity for at least two months, the composition maintains a propofol concentration (w/v)
`
`measured by HPLC that is at least 95% of the starting concentration (w/v) of the propofol.
`
`84.
`
`(Currently Amended) The sterile pharmaceutical composition in a container
`
`according to claim 1, the composition comprising less than about 0.5% by weight solvent
`
`for propofol, and the closure comprises a material selected from the group consisting of a
`
`fluoropolymer, a metal, and butyl rubber coated 'vtlith a fluoropolymer.
`
`85.
`
`(Currently Amended) The sterile pharmaceutical composition in a container
`
`according to claim 1, the composition comprising from about 0.5% to about 6% by weight
`
`solvent for propofol, and the closure comprises a material selected from the group
`
`consisting of a fluoropolymer, a metal, butyl rubber coated with a fluoropolymer,
`
`bromobutyl rubber and chlorobutyl rubber.
`
`86.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 85, the composition comprising from about 3% to about 6% by weight
`
`solvent for propofol.
`
`87.
`
`(Previously presented) The sterile pharmaceutical composition in a container
`
`according to claim 86, the solvent comprising soybean oil.
`
`88.
`
`(Cancelled)
`
`14
`
`Exh. 1020
`
`

`
`Serial No. 10/616,70 9
`
`PATENT
`Docket No. FKA01 005 US
`
`Claims 20, 22, 23, 26, 44, 46, 47, 50, 57, 59, 60, 63 and 88 are cancelled.
`
`REMARKS
`
`Claims 1, 29, 52, 84 and 85 are amended. The amendment to claim 1 is supported
`
`by claims 24, 25 and 27. The amendment to claim 29 is supported by claims 48, 49 and
`
`51. The amendment to claim 52 is supported by claims 61, 62 and 64. Claims 84 and 85
`
`are amended to maintain consistency with amended claim 1.
`
`No new matter has been added. Claims 1-19,21,24, 25,27-43,45,48, 49,51 -56,
`
`58, 61, 62, 64, 68, 69 and 71-87 are pending.
`
`INTERVIEW SUMMARY
`
`Applicants would like to thank Examiners Teller, Tate and Weber for the helpful
`
`discussion with Applicants' representatives on November 13, 2012. During this
`
`discussion, the independent claims were reviewed with respect to the cited references.
`
`Agreement was reached regarding the inapplicability of the cited references U.S. Patent
`
`No. 6,576,245 to Lundgren et al. and Sautou-Miranda, Int.]. Pharm. 130, 251-255, 1996.
`
`Agreement also was reached regarding the distinctness of the claim term "closure" with
`
`regard to the claim term "container". In addition, Applicants' representatives reviewed
`
`how the following phrase in each of the independent claims recites a test for determining
`
`the stability of propofol within the claimed container:
`
`... where when the composition in the container sealed with the closure is
`agitated at a frequency of 300-400 cycles/minute for 16 hours at room
`temperature, the composition maintains a propofol concentration (w/v)
`measured by HPLC that is at least 93% of the starting concentration (w/v) of
`the propofoll ...
`
`Agreement was reached regarding the propriety of this test phrase in view of the
`
`requirements of 35 U.S.C. 112.
`
`15
`
`Exh. 1020
`
`

`
`Serial No. 10/616,70 9
`
`PATENT
`Docket No. FKA01 005 US
`
`REQUEST FOR RECONSIDERATION
`
`Applicants would like to thank Examiner Tel ler for indicating that claims 21, 25, 45,
`
`48, 49, 51, 58, 61, 62 and 64 contain allowable subject matter. Applicants note that
`
`claims 24 and 27 appear to have been inadvertently omitted in the examiner's list of
`
`allowable claims, as they recite the same closure materials as allowed claims 48, 51, 61
`
`and 64. The preceding claim amendments are believed consistent with the allowed
`
`subject matter. Applicants reserve their right to pursue the original claims in a
`
`continuation application.
`
`CONCLUSION
`
`The Examiner is respectfully requested to telephone jonathan P. Taylor at (312) 612-6700
`
`to resolve any outstanding issues as expeditiously as possible so the case may be passed to
`
`issue.
`
`Respectfully Submitted,
`
`I Jonathan P. Taylor, Reg. No. 48338 I
`j onathan P. Taylor
`Patent Agent
`Registration No. 48,338
`
`February 4, 2013
`Date
`
`Blancha rd & Associates
`566 West Adams Street
`Suite 600
`Ch icago, IL 60661
`Docketi ng@blanchard-patent.com
`Tel. (312) 612-6700
`
`16
`
`Exh. 1020