Notice of Allowability
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`Application No.
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`10/616,709
`Examiner
`ROY TELLER
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`Applicant(s)
`DESAI ET AL.
`Art Unit
`AIA (First Inventor to
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`File) Status
`1654
`No
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`--The MAILING DA TE of this communication
`appears on the cover sheet with the correspondence address-­
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`All claims being allowable, PROSECUTION ON THE MERITS IS (OR REMAINS) CLOSED in this application. If not included
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`herewith (or previously mailed), a Notice of Allowance (PTOL-85) or other appropriate communication will be mailed in due course. THIS
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`NOTICE OF ALLOWABILITY IS NOT A GRANT OF PATENT RIGHTS. This application is subject to withdrawal from issue at the initiative
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`of the Office or upon petition by the applicant. See 37 CFR 1.313 and MPEP 1308.
`1. 181 This communication
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`is responsive to the amendment
`filed 2/4/2013.
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`DA declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on ___ .
`2.0 An election
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`requirement and election have been incorporated into this action.
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`was made by the applicant in response to a restriction requirement set forth during the interview on __ ; the restriction
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`3.181 The allowed claim(s) is/are
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`and 71-87. As a result of the allowed
`1-9.11-19.21.24.25.27-43.45.48.49.51-56.58.61.62.64.68.69
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`claim(s), you may be eligible to benefit from the Patent Prosecution Highway program at a participating intellectual property office
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`for the corresponding application. For more information, please see http://www.uspto.gov/gatents
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`/init events!pgh/index.isp or send an
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`inquiry to PPHfeedback@usoto.gov.
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`or (f).priority under 35 U.S.C. § 119(a)-(d) 4.D Acknowledgment is made of a claim for foreign
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`Certified copies:
`a) D Allb)D Some *c) D None of the:
`have been received.1.0 Certified copies of the priority documents
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`No. __ .in Application documents have been received 2.D Certified copies of the priority
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`International Bureau (PCT Rule 17.2(a)).
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`•Certified copies not received: __ .
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`Interim copies:
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`from thestage application in this national documents have been received 3.D Copies of the certified copies of the priority
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`a)D All b) D Some c) D None of the: Interim copies of the priority documents have been received.
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`Applicant has THREE MONTHS. FROM THE "MAILING DATE" of this communication to file a reply complying with the requirements
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`noted below. Failure to timely comply will result in ABANDONMENT of this application.
`THIS THREE-MONTH PERIOD IS NOT EXTEND ABLE.
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`5.D CORRECTED DRAWINGS ( as "replacement sheets") must be submitted.
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`Paper No./Mail Date __ .
`Identifying indicia such as the application number (see 37 CFR 1.84(c)) should be written on the drawings in the 1ront (not the back) of
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`each sheet. Replacement sheet(s) should be labeled as such in the header according to 37 CFR 1.121(d).
`6.0 DEPOSIT OF and/or INFORMATION
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`about the deposit of BIOLOGICAL MATERIAL must be submitted. Note the
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`attached Examiner's comment regarding REQUIREMENT FOR THE DEPOSIT OF BIOLOGICAL MATERIAL.
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`of I Comment or in the Office action Examiner's Amendment by the attached D including changes required
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`Attachment(s)
`1.D Notice of References Cited (PT0-892)
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`(PTO/SB/08),2.D Information Disclosure Statements
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`Paper No./Mail Date __
`7.0 Other __ .
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`Deposit3.0 Examiner's Comment Regarding Requirement for
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`of Biological Material
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`4.181 Interview Summary (PT0-413),
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`Paper No./Mail Date 4130113.
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`5.181 Examiner's
`Amendment/Comment
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`6.D Examiner's Statement of Reasons for Allowance
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`/Roy Teller/
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`Examiner, Art Unit 1654
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`Bass and Spangenberg
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`V.
`Fresenius Kabi USA, LLC
`U.S. Paten
`t No. 8,476,010
`Exhibit 1022
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`U.S. Patent and Trademark ott,ce
`PTOL-37 (Rev. 03-13)
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`Notice of Allowability
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`Part of Paper No./Mail Date 20130507
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`Exh. 1022
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`Application/Control Number: 10/616,709
`Art Unit: 1654
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`Page2
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`The amendment filed 2/4/2013 has been received and entered.
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`EXAMINER' S AMENDMENT
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`An examiner's amendment to the record appears below. Should the changes and/or
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`additions be unacceptable to applicant, an amendment may be filed as provided by 37 CFR
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`1.312. To ensure consideration of such an amendment, it MUST be submitted no later than the
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`payment of the issue fee.
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`Authorization for this examiner 's amendment was given in a telephone interview with
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`Jonathan Taylor on 5/3/2013.
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`IN THE CLAIMS:
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`1.
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`(Currently Amended) A sterile pharmaceutical composition of propofol in a
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`container, comprising:
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`a container which includ es a closure and a composition in the container, and
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`the composition in the container comprising from 0.5% to 10% by weight
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`propofol and less than from about 0 to about 10% by weight solvent for propofol,
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`where when the composition in t he container sealed with the closure is agitated
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`at a frequency of 300-400 cycles/minute for 16 hours at room temperature, the
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`composition maintains a propofol concentration (w/v) measured by HPLC that is at least
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`93% of the starting concentration (w/v) of the propofol;
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`where the closure is selected from the group consisting of siliconized bromobutyl
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`rubber. metal, and siliconized chlorobutyl rubber.
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`Exh. 1022
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`Application/Control Number: 10/616,709
`Art Unit: 1654
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`10. (Cancel)
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`Page 3
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`11. (Currently Amended) The sterile pharmaceutical composition in a container
`according to claim [[10]] 1 wherein the solvent is a water-immiscible solvent.
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`14. (Currently Amended) The sterile pharmaceutical composition in a container
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`according to claim [[10]] 1, wherein the solvent is selected from the group consisting of
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`chloroform, methylene chloride, ethyl acetate, ethanol, tetrahydrofuran, dioxane,
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`acetonitrile, acetone, dimethyl sulfoxide, dimethyl formamide, methyl pyrrolidinone, C1-
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`C20 alcohols, C2-C20 esters, C3-C20 ketones, polyethylene glycols, aliphatic
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`hydrocarbons, aromatic hydrocarbons, halogenated hydrocarbons and combinations
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`thereof.
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`21.
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`(Currently Amended) The sterile pharmaceutical composition in a container
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`according to claim 19, wherein the closure material is a non rubber selected from the
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`group consisting of metal, plastics, and mi><tures thereof.
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`25.
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`(Currently Amended) The sterile pharmaceutical composition in a container
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`according to claim 1, wherein the closure comprises a non rubber selected from the
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`group consisting of metal, plastics, and mixtures thereof.
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`29.
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`(Currently Amended) A sterile pharmaceutical composition of propofol in a
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`container, comprising:
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`a containerr which includes a closure and an oil-in-water emulsion for parenteral
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`administration of propofol in the container,
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`the emulsion comprising an oil phase comprising propofol and a solvent for
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`propofol, and an aqueous phase comprising water for injection,
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`Exh. 1022
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`Application/Control Number: 10/616,709
`Art Unit: 1654
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`Page4
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`the emulsion comprising less than from about 0 to about 10% by weight of the
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`solvent,
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`the emulsion further comprising a stabilizing layer for the oil phase, the
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`stabilizing layer comprising a surfactant and a protein;
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`where when the emulsion in the container sealed with the closure is agitated at a
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`frequency of 300-400 cycles/minute for 16 hours at room temperature, the emulsion
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`maintains a propofol concentration (w/v) measured by HPLC that is at least 93% of the
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`starting concentration (w/v) of the propofol;
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`where the closure is selected from the group consisting of siliconized bromobutyl
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`rubber, a non rubber selected from the group consisting of metal, plastics, and miJctures
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`thereof, and siliconized chlorobutyl rubber.
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`45.
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`(Currently Amended) The sterile pharmaceutical composition in a container
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`according to claim 43, wherein the closure material is a non rubber selected from the
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`group consisting of metal, plastics, and mi><tures thereof.
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`49.
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`(Currently Amended) The sterile pharmaceutical composition in a container
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`according to claim 29, wherein the closure comprises a non rubber selected from the
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`group consisting of metal, plastics, and mi><tures thereof.
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`52.
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`(Currently Amended) A sterile, injectable pharmaceutical composition in a
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`container, comprising:
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`a container which includ es a closure and a composition in the container, the
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`composition comprising
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`a) microdroplets having a mean size of from about 20 nanometers to
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`about 1000 nanometers, the microdroplets comprising a sphere of propofol surrounded
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`Exh. 1022
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`Application/Control Number: 10/616,709
`Art Unit: 1654
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`PageS
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`by a stabilizing layer comprising a phospholipid and devoid of oils capable of
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`supporting bacterial growth; and
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`b) a pharmaceutically acceptable injectable carrier;
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`where when the composition in the container sealed with the closure is agitated
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`at a frequency of 300-400 cycles/minute for 16 hours at room temperature, the
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`composition maintains a propofol concentration (w/v) measured by HPLC that is at least
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`93% of the starting concentration (w/v) of the propofol;
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`where the closure is selected from the group consisting of siliconized bromobutyl
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`rubber, a non rubber selected from the group consisting of metal, plastics, and mi><hHes
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`thereof, and siliconized chlorobutyl rubber.
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`58.
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`(Currently Amended) The sterile, injectable pharmaceutical composition in a
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`container according to claim 56, wherein the closure material is a non rubber selected
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`from the group consisting of metal, plastics, and mi><tures thereof.
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`62.
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`(Currently Amended) The sterile, injectable pharmaceutical composition in a
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`container according to claim 52, wherein the closure comprises a non rubber selected
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`from the group consisting of metal, plastics and mixtures thereof.
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`Claims 1-9, 11-19,21,24-25, 27-43,45,48-49,51-56,58, 61-62,64, 68-69,71-87 are
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`Conclusion
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`allowed.
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`Any inquiry conceming this communication or earlier communications from the
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`examiner should be directed to ROY TELLER whose telephone number is (571)272-0971. The
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`examiner can normally be reached on Monday-Friday from 5:30 am to 2:00pm.
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`Exh. 1022
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`Application/Control Number: 10/616,709
`Art Unit: 1654
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`Page6
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner's
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`supervisor, Cecilia T sang, can be reached on 571-272-0562. The fax phone number for the
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`organization where this application or proceeding is assigned is 571-273-8300.
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`Information regarding the status of an application may be obtained from the Patent
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`applications is avaiaable through Private PAIR only. For more inf01mation about the PAIR
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`Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
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`/Roy Teller/
`Examiner, Art Unit 1654
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`/JON P WEBER/
`Supervisory Patent Examiner, Att Unit 1657
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`Exh. 1022