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`Case 1:14—cv—O1453—LPS Document 43-4 Filed 10/22/15 Page 1 of 37 Page|D #: 320
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`
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`EXHIBIT 7
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`EXHIBIT 7
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`

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`Case_.1:14—'Q§/—01453—LPS Document 43-4 Filed 10/22/15 Page 2 of 31FQg(=.51:32@ 16
`mos Rec'd PCT/PTO 1 4 use 2094
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`'
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`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re the Application
`
`Amar LULLA et 211.
`
`Serial No.: To be assigned (National Stage ofPCT/GB03/02557 filed June 13, 2003)
`
`Filed: December 14, 2004
`
`For: COMBINATION OF AZELASTINE AND STEROIDS
`
`PRELIMINARY AMENDMENT
`
`Mail Stop Patent Application
`Commissioner for Patents
`P.O. Box 1450
`
`Alexandria, VA 22313-1450
`
`Sir:
`
`Prior to the calculation of the filing fee, please amend the above-identified application as
`
`follows:
`
`M ED_DYM_0OOOOO64
`
`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 3 of 37 PageID #: 322
`Case‘1:14—‘t‘:v—O1453—LPS Document 43-4 Filed 10/22/15 Page 3 of 37 Page|D #: 322
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`IN THE SPECIFICATION
`
`Please add the following paragraph on a new line afier the title:
`
`This application is a §371 National Stage Application of International Application No.
`
`PCT/GB03/02557, filed on 13 June 2003, claiming the priority of Great Britain Patent
`
`Application No. 0213739.6 filed on 14 June 2002, the entire disclosures of which are herein
`
`incorporated by reference in their entirety.
`
`MED_DYM_0OO0OO65
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`

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`IN THE ABSTRACT
`
`After the last page of claims, insert on a new page the Abstract shown on the attached
`
`sheet (ATTACHMENT 1).
`
`MED_DYM_0OOOOO66
`
`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 5 of 37 PageID #: 324
`Case_|1:14—”c::§/—01A’.53—LPS Document 43-4 Filed 10/22/15 Page 5 of 37 Page|D #: 324
`
`IN THE CLAIMS
`
`Please cancel claim 43.
`
`1.
`
`(Currently Amended) A pharmaceutical formulation which comprises azelastine,
`
`or a pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof,
`
`and a steroid, or a pharmaceutically acceptable salt, solvate or physiologically functional
`
` derivative thereof,
`
`1
`
`.
`
`.
`
`.
`
`l
`
`2.
`
`(Original) A pharmaceutical fomiulation according to claiml, wherein said
`
`azelastine is present as azelastine hydrochloride.
`
`3.
`
`(Currently Amended) A formulation according to claim 1—er—2, wherein the
`
`steroid is beclomethasone or a pharrnaceutically acceptable ester thereof, mometasone or a
`
`pharrnaceutically acceptable ester thereof, fluticasone or a pharmaceutically acceptable ester
`
`thereof, budesonide or cyclosenide, in any chiral form or mixture.
`
`4.
`
`(Original) A formulation according to claim 3, wherein the steroid is
`
`beclomethasone propionate, mometasonefiiroate, mometasone furoate monohydrate, fluticasone
`
`propionate or fluticasone valerate.
`
`5.
`
`(Currently Amended) A formulation according to claim 1 ,
`
`which contains the steroid in an amount from about 50 micrograms/ml to about 5 mg/ml of the
`
`formulation.
`
`6.
`
`(Currently Amended) A formulation according to claim 1 ,
`
`wherein the formulation has a particle size of less than about 10 um .
`
`MED_DYM_0OOOOO67
`
`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 6 of 37 PageID #: 325
`Case_1:14—‘cv—O1453—LPS Document 43-4 Filed 10/22/15 Page 6 of 37 Page|D #: 325
`
`7.
`
`(Currently Amended) A formulation according to claim 1 ,
`
`which is a suspension containing 0.0005 to 2% (weight/weight of the formulation) of azelastine
`
`or a pharmaceutically acceptable salt of azelastine, and from 0.5 to 1.5% (weight/weight of the
`
`formulation) of said steroid.
`
`8.
`
`(Original) A formulation according to claim 7, which contains from 0.001 to 1%
`
`(weight/weight of the formulation) azelastine, or salt thereof, and from 0.5% to 1.5%
`
`(weight/weight of the formulation) steroid.
`
`9.
`
`(Currently Amended) A formulation according to claim 1 ,
`
`which also contains a surfactant.
`
`10.
`
`(Original) A formulation according to claim 9, wherein the surfactant comprises a
`
`polysorbate or poloxamer surfactant.
`
`11.
`
`(Currently Amended) A formulation according to claim 9 er—l-0, which contains
`
`from about 50 micrograms to about 1 milligram of surfactant per ml of the formulation.
`
`12.
`
`(Currently Amended) A formulation according to claim 1 ,
`
`which also contains an isotonic agent.
`
`13.
`
`(Original) ‘A formulation according to claim 12, wherein the isotonic agent
`
`comprises sodium chloride, saccharose, glucose, glycerine, sorbitol or 1,2-propylene glycol.
`
`14.
`
`(Currently Amended) A formulation according to claim; ,
`
`which also contains at least one additive selected from the group consisting of a buffer, a
`
`preservative. and a suspending agent and a of thickening agent.
`
`15.
`
`(Original) A formulation according to claim 14, wherein said preservative is
`
`selected from edetic acid and its alkali salts, lower alkyl p-hydroxybenzoates, chlorhexidine,
`
`MED_DYM_0OOOOO68
`
`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 7 of 37 PageID #: 326
`Case'1:14—'c\;/—O1453—LPS Document 43-4 Filed 10/22/15 Page 7 of 37 Page|D #: 326
`
`phenyl mercury borate, or benzoic acid or a salt, a quaternary ammonium compound, or sorbic
`
`acid or a salt thereof.
`
`16.
`
`(Currently Amended) A formulation according to claim 14 er—l§, wherein the
`
`suspending agent or thickening agent is selected from cellulose derivatives, gelatin,
`
`polyvinylpyrrolidone, tragacanth, ethoxose (water soluble binding and thickening agents on the
`
`basis of ethyl cellulose), alginic acid, polyvinyl alcohol, polyacrylic acid, or pectin.
`
`17.
`
`(Currently Amended) A formulation according to claim 14%
`
`-16, wherein the buffer comprises a citric acid-citrate buffer.
`
`18.
`
`(Currently Amended) A formulation according to claim 14 an=yeei1elaims—l-4,-lé;
`
`-L6-er—l-7, wherein the buffer maintains the pH of the aqueous phase at from 3 to 7, preferably 4.5
`
`to about 6.5.
`
`19.
`
`(Currently Amended) A formulation according to claim 1 ,
`
`which is an aqueous suspension or solution.
`
`20.
`
`(Currently Amended) A formulation according to claim 1 -1-9, which is in the form
`
`of an aerosol, an ointment, eye drops, nasal drops, a nasal spray, or an inhalation solution £1
`
`other forms suitable for nasal or ocular administration.
`
`21.
`
`(Original) A formulation according to claim 20, which is in the form of nasal
`
`drops or nasal spray.
`
`22.
`
`(Original) A formulation according to claim 20, which is in the form of an
`
`aerosol.
`
`23.
`
`(Original) A pressure packing having a dosage or metering valve, which contains
`
`a formulation according to claim 22.
`
`MED_DYM_0OOOOO69
`
`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 8 of 37 PageID #: 327
`Case 1:141c',\/—01Z.53—LPS Document 43-4 Filed 10/22/15 Page 8 of 37 Page|D #2. 327
`
`24.
`
`(Original) A MDI which includes a pressure packing according to claim 23.
`
`25. _
`
`(Currently Amended) A formulation according to claim 1 ,
`
`which is in the form of an insufflation powder.
`
`26.
`
`(Currently Amended) A pharmaceutical product according to claim 1, comprising
`
`(i) azelastine, or a pharmaceutically acceptable salt, solvate or physiologically functional
`
`derivative thereof, provided in an aerosol formulation preferably together with a propellant
`
`typically suitable for MDI delivery, and (ii) at least one steroid, or a pharmaceutically acceptable
`
`salt, solvate or physiologically functional derivative thereof, provided in an aerosol formulation
`
`preferably together with a propellant typicallyhsuitable for MDI delivery, as a combined
`
`preparation for simultaneous, separate or sequential use in the treatment of conditions for which
`
`administration of one or more anti-histamine and/or one or more steroid is indicated.
`
`27.
`
`(Currently Amended) An aerosol formulation preferably suitable for MDI
`
`delivery comprising
`
`
`
`together with a propellant.
`
`28.
`
`(Original) A pharmaceutical product comprising (i) azelastine, or a
`
`pharrnaceutically acceptable salt, solvate or physiologically functional derivative thereof,
`
`provided as an insufflation powder, and (ii) at least one steroid, or a pharrnaceutically acceptable
`
`salt, solvate or physiologically functional derivative thereof, provided as an insufflation powder,
`
`as a combined preparation for simultaneous, separate or sequential use in the treatment of
`
`MED_DYM_0OOOOO70
`
`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 9 of 37 PageID #: 328
`Case.1:14—'q/—O1A'.53—LPS Document 43-4 Filed 10/22/15 Page 9 of 37 Page|D #: 328
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`conditions for which administration of one or more anti-histamine and/or one or more steroid is
`
`indicated.
`
`29.
`
`(Original) An insufflation powder formulation comprising (i) azelastine, or a
`
`pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, and (ii)
`
`at least one steroid, or a pharmaceutically acceptable salt, solvate or physiologically fiinctional
`
`derivative thereof, together with a pharmaceutically acceptable carrier or excipient therefor.
`
`30.
`
`(Currently Amended) A pharmaceutical product comprising the formulation
`
`according to claim I, wherein (i) azelastine, or a pharmaceutically acceptable salt thereof, and
`
`(ii) wherein at least one steroid i_s selected from the group consisting of beclomethasone,
`
`fluticasone, mometasone and pharmaceutically acceptable esters thereof, as a combined
`
`preparation with said azelastine for simultaneous, separate or sequential use in the treatment of
`
`conditions for which administration of one or more anti-histamine and/or one or more steroid is
`
`indicated.
`
`31.
`
`(Currently Amended) A pharmaceutical formulation according to claim 1,
`
` wherein said
`
`least one steroid i_s selected from the group consisting of beclomethasone, fluticasone,
`
`mometasone and pharmaceutically acceptable esters thereof, together with a pharmaceutically
`
`acceptable carrier or excipient therefor.
`
`32.
`
`(Currently Amended) The formulation of claim 3 in the form of a [[A]] nasal
`
`spray comprising azelastine, or a pharmaceutically acceptable salt thereof, together with
`
`mometasone either as mometasone free base or as mometasonefuroate, and a pharmaceutically
`
`acceptable carrier or excipient therefor.
`
`MED_DYM_0OOOOO71
`
`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 10 of 37 PageID #: 329
`Case _1I:14—c‘:ri\‘_/—014'53—LPS Document 43-4 Filed 10/22/15 Page 10 of 37 Page|D #: 329
`
`33.
`
`(Currently Amended) A pharmaceutical product comprising the formulation
`
`according to claim 1, wherein said azelastine is azelastine hydrochloride and said steroid is
`
`beclomethasone dipropionate, as a combined preparation for simultaneous, separate or sequential
`
`use in the treatment of conditions for which administration of one or more anti-histamine and/or
`
`one or more steroid is indicated.
`
`34.
`
`(Currently Amendedl) A pharmaceutical formulation according to claim 1,
`
`wherein said azelastine is eemprising azelastine hydrochloride and said steroid is
`
`beclomethasone dipropionate, together with a pharmaceutically acceptable carrier or excipient
`
`therefor.
`
`35.
`
`(Currently Amended) A pharmaceutical product comprising the pharmaceutical
`
`
`formulation of claim 1 wherein said azelastine is azelastine hydrochloride and said steroid is
`
`fluticasone propionate, as a combined preparation for simultaneous, separate or sequential use in
`
`the treatment of conditions for which administration of one or more anti-histamine and/or one or
`
`more steroid is indicated.
`
`36.
`
`(Currently Amended) A pharmaceutical formulation according to claim 1,
`
`wherein said azelastine is eemprising azelastine hydrochloride and said steroid is fluticasone
`
`propionate, together with a pharmaceutically acceptable carrier or excipient therefor.
`
`37.
`
`(Currently Amended) A pharmaceutical product comprising the pharmaceutical
`
`
`formulation of claim 1 wherein said azelastine is azelastine hydrochloride and said steroid is
`
`fluticasone valerate, as a combined preparation for simultaneous, separate or sequential use in
`
`the treatment of conditions for which administration of one or more anti-histamine and/or one or
`
`more steroid is indicated.
`
`MED_DYM_0OOOOO72
`
`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 11 of 37 PageID #: 330
`Case_;:14—'cv—O1453—LPS Document 43-4 Filed 10/22/15 Page 11 of 37 Page|D #: 330
`
`38.
`
`(Currently Amended) A pharmaceutical formulation according to claim 1,
`
`wherein said azelastine is eempfising azelastine hydrochloride and said steroid is fluticasone
`
`valerate, together with a pharmaceutically acceptable carrier or excipient therefor.
`
`39.
`
`(Currently Amended) A pharmaceutical product comprising the pharmaceutical
`
`
`formulation of claim 1 wherein said steroid is azelastine hydrochloride and said steroid is
`
`mometasonefuroate, as a combined preparation for simultaneous, separate or sequential use in
`
`the treatment of conditions for which administration of one or more anti-histamineand/or one or
`
`more steroid is indicated.
`
`40.
`
`(Currently Amended) A pharmaceutical formulation according to claim 1,
`
`wherein said azelastine is eemprisin-g azelastine hydrochloride and said steroid is
`
`mometasonefuroate, together with a pharmaceutically acceptable carrier or excipient therefor.
`
`41.
`
`(Currently Amended) A pharmaceutical product comprising the pharmaceutical
`
`
`formulation of claim 1 wherein said azelastine is azelastine hydrochloride and said steroid is
`
`mometasonefuroate monohydrate, as a combined preparation for simultaneous, separate or
`
`sequential use in the treatment of conditions for which administration of one or more anti-
`
`histamine and/or one or more steroid is indicated.
`
`42.
`
`(Currently Amended) A pharmaceutical formulation according to claim 1,
`
`wherein said azelastine is eemprising azelastine hydrochloride and said steroid is
`
`mometasonefuroate monohydrate, together with a pharrnaceutically acceptable carrier or
`
`excipient therefor.
`
`43.
`
`Cancelled
`
`10
`
`MED_DYM_0OOOOO73
`
`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 12 of 37 PageID #: 331
`CaseL1:14—'cv—01453—LPS Document 43-4 Filed 10/22/15 Page 12 of 37 Page|D #: 331
`
`44.
`
`(Currently Amended) A process of preparing a pharmaceutical product according
`
`to claim 26 , which process comprises providing (i)
`
`azelastine, or a pharmaceutically acceptable salt, solvate or physiologically functional derivative
`
`thereof, and (ii) at least one steroid, or a pharmaceutically acceptable salt, solvate or
`
`physiologically functional derivative thereof, as a combined preparation for simultaneous,
`
`separate or sequential use in the treatment of conditions for which administration of one or more
`
`antihistamine and/or one or more steroid is indicated.
`
`45.
`
`(Currently Amended) A proces_s of preparing a pharmaceutical formulation
`
`according to glaim_l , which process
`
`comprises admixing a pharmaceutically acceptable carrier or excipient with azelastine, or a
`
`pharmaceutically acceptable salt, solvate or physiologically functional derivative thereof, and at
`
`least one steroid, or a pharmaceutically acceptable salt, solvate or physiologically functional
`
`derivative thereof.
`
`46.
`
`(Currently Amended) A method for the prophylaxis or treatment in a mammal,
`
`such as a human, of conditions for which administration of one or more anti—histamine and/or
`
`one or more steroid is indicated, which method comprises administration of a therapeutically
`
`effective amount of a pharmaceutical product according to claim 26wye
`
` , as a combined preparation for simultaneous, separate or sequential use in the
`
`treatment of such conditions.
`
`47.
`
`(Currently Amended) A method for the prophylaxis or treatment in a mammal,
`
`such as a human, of conditions for which administration of one or more anti—histamine and/or
`
`one or more steroid is indicated, which method comprises administration of a therapeutically
`
`‘11
`
`M ED_DYM_0OOOOO74
`
`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 13 of 37 PageID #: 332
`Case_l1:14—'ci/—01Al53—LPS Document 43-4 Filed 10/22/15 Page 13 of 37 Page|D #: 332
`
`effective amount of a pharmaceutical formulation according to c_lain_Q a-ay—ef—elai-ms-l—te—2-2,—2—7—,
`
`48.
`
`(Currently Amended) For use in the manufacture of a medicament for the
`
`prophylaxis or treatment in a mammal, such as a human, of conditions for which administration
`
`of one or more antihistamine and/or one or more steroid is indicated, a pharmaceutical product
`
`according to claim 26 , as a combined preparation
`
`for simultaneous, separate or sequential use in the treatment of such conditions.
`
`49.
`
`(Currently Amended) A method of treating irritation or disorders of the nose or
`
`eye which comprises applying either directly to nasal tissues or to the conjunctiva] sac of the
`
`eyes, as appropriate, a pharmaceutical product according to claim 26
`
`
`
`50.
`
`(Currently Amended) A method of treating airway disorders, comprising
`
`administering by nebulization to surfaces of the airway a treatment-effective amount of a product
`
`or formulation as defined in claim 1
`
`51.
`
`(New) A method of treating irritation or disorders of the nose or eye which
`
`comprises applying either directly to nasal tissues or to the conjunctival sac of the eyes, as
`
`appropriate, a pharmaceutical formulation of claim 1.
`
`52.
`
`(New) A method of treating airway disorders, comprising administering by
`
`nebulization to surfaces of the airway a treatment-effective amount of a product according to
`
`claim 26.
`
`12
`
`MED_DYM_0OO0OO75
`
`

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`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 14 of 37 PageID #: 333
`Case.'1:14—‘cy—01453—LPS Document 43-4 Filed 10/22/15 Page 14 of 37 Page|D #: 333
`
`REMARKS
`
`The claims have been amended to delete the multiple dependent claim status. No new
`
`matter is presented by the above amendments. Early and favorable consideration of this
`
`application is respectfully requested.
`
`Date: M lL( ( 166 \'(
`
`TPP/pgw
`ATTORNEY DOCKET NO. TPP31573
`
`STEVENS, DAVIS, MILLER & MOSHER, L.L.P.
`1615 L STREET, N.W., SUITE 850
`WASHINGTON, D.C. 20036
`TEL. 202-785-0100 / FAX. 202-785-0200
`
`Respectfully submitted,
`
` ~
`
`Thomas P. Pavelko
`
`Registration No. 31,689
`
`13
`
`MED_DYM_0OOOOO76
`
`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 15 of 37 PageID #: 334
`Case 1:14—cv—O1453—LPS Document 43-4 Filed 10/22/15 Page 15 of 37 Page|D #: 334
`
`
`
`EXHIBIT 8
`
`EXHIBIT 8
`
`
`
`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 16 of 37 PageID #: 335
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMIS S IONER FOR PATENTS
`P.O. Box 1450
`Alexandria. Virginia 22313-1450
`www.uspto.goV
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONE (MATION NO.
`
`
`
`10/518,016
`
`07/06/2005
`
`Amar Lulla
`
`TPP31753
`
`4912
`
`01/23/2009
`
`77176
`7590
`N0Vak,Druce&QuiggLLP
`1300 I Street, N.W.
`Suite 1000, West Tower
`WASHINGTON, DC 20005
`
`BROOKS, KRISTIE LATRICE
`
`1616
`
`MAIL DATE
`
`01/23/2009
`
`DELIVERY MODE
`
`PAPER
`
`Please find below and/or attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`PTOL—90A (Rev, 04/07)
`
`M ED_DYM_0OOOO254
`
`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 17 of 37 PageID #: 336
`Case 1:14—cv—01453—LPS Document 43-4 Filed 10/22/15 Page 17 of 37 PagelD #: 336
`Application No.
`App|icant(s)
`
`Office Action Summary
`
`10/518,016
`
`LULLA ET AL.
`
`Examine,
`KRISTIE L. BROOKS
`
`Art Unit
`1616
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE Q MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`- Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
`
`1)IXI Responsive to communication(s) filed on 06 July 2005.
`
`2a)I:I This action is FINAL.
`
`2b)IXI This action is non-final.
`
`3)I:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under EX parte Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims
`
`4) C|aim(s) 1-42 and 44-52 is/are pending in the application.
`
`4a) Of the above c|aim(s) 23,24 and 46-52 is/are withdrawn from consideration.
`
`5)I:I C|aim(s)j is/are allowed.
`
`6) C|aim(s) 1-22 25-42 44 and 45 is/are rejected.
`
`7)I:I C|aim(s)j is/are objected to.
`
`8)I:I C|aim(s)j are subject to restriction and/or election requirement.
`
`Application Papers
`
`9)I:I The specification is objected to by the Examiner.
`
`is/are: a)|:I accepted or b)|:I objected to by the Examiner.
`10)I:I The drawing(s) filed on
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
`
`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
`
`Priority under 35 U.S.C. § 119
`
`12) Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(3)-(d) or (f).
`
`a)IZ All
`
`b)I:I Some * c)I:I None of:
`
`1. Certified copies of the priority documents have been received.
`
`2.|:I Certified copies of the priority documents have been received in Application No.
`
`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
`application from the International Bureau (PCT Rule 17.2(a)).
`
`* See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`Notice of References Cited (PTO-892)
`1)
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`3)
`Information Disclosure Statement(s) (PTO/SB/08)
`
`Paper No(s)/Mail Date 7/6/05'10/5/05.
`U.S. Patent and Trademark Office
`PTOL—326 (Rev. 08-06)
`
`Office Action Summary
`
`4) D Interview Summary (PTO-413)
`Paper N0(S)/IVI3" Date- 2
`5) I:I Nome 0‘ Informal Patent APP"Cat'0"
`6) D Other:
`.
`
`Part of Paper No./Mail Date 20090121
`
`MED_DYM_0OO0O255
`
`

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`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 18 of 37 PageID #: 337
`Case 1:14—cv—01453—LPS Document 43-4 Filed 10/22/15 Page 18 of 37 PagelD #: 337
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`Application/Control Number: 10/518,016
`Art Unit: 1616
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`Page 2
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`DETAILED ACTION
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`1.
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`The previous non—final office action mailed October 17, 2008 is hereby vacated
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`and a new office action is presented below.
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`Election/Restrictions
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`2.
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`Restriction to one of the following inventions is required under 35 U.S.C. 121:
`
`I.
`
`Claims 1-22, and 2542 and 44-45 are drawn to a pharmaceutical
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`formulation comprising azelastine and a steroid, classified in class 514,
`
`subclass 171.
`
`ll.
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`Claims 23-24 are drawn to drawn to a pressure packing, classified in class
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`128, subclass 200.23.
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`Ill.
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`Claims 46-52 are drawn to a method of use, classified in class 514,
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`subclass 171.
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`The inventions are distinct, each from the other because of the following reasons:
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`Inventions I and II are directed to related products. The related inventions are
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`distinct if: (1) the inventions as claimed are either not capable of use together or can
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`have a materially different design, mode of operation, function, or effect; (2) the
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`inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as
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`claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the
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`inventions as claimed do not overlap in scope because the two inventions have
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`materially different design and mode of operation. Invention II is drawn to a pressure
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`packing device or metered dose inhaler where a composition is delivered by spray or
`
`M ED_DYM_0OOOO256
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`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 19 of 37 PageID #: 338
`Case 1:14—cv—01453—LPS Document 43-4 Filed 10/22/15 Page 19 of 37 PagelD #: 338
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`Application/Control Number: 10/518,016
`Art Unit: 1616
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`Page 3
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`aerosol which is different from the pharmaceutical formulation of Invention I.
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`Furthermore, the inventions as claimed do not encompass overlapping subject matter
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`and there is nothing of record to show them to be obvious variants.
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`Inventions I and III are related as product and process of use. The inventions
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`can be shown to be distinct if either or both of the following can be shown: (1) the
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`process for using the product as claimed can be practiced with another materially
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`different product or (2) the product as claimed can be used in a materially different
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`process of using that product. See MPEP § 806.05(h).
`
`In the instant case, the product
`
`of invention I can be used in a materially different process, such as, improving vision .
`
`Inventions II and III are related as product and process of use. The inventions
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`can be shown to be distinct if either or both of the following can be shown: (1) the
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`process for using the product as claimed can be practiced with another materially
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`different product or (2) the product as claimed can be used in a materially different
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`process of using that product. See MPEP § 806.05(h).
`
`In the instant case, the process
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`of Invention Ill, can be used with a materially different product, such as, without the
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`pressure packing device or metered dose inhaler of Invention ll.
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`3.
`
`For purpose of examination, the Examiner has requested Applicant to
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`provisionally elect a single steroid selected from: beclomethasone, mometasone,
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`fluticasone, or a pharmaceutically acceptable ester thereof, budesonide or cyclosenide.
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`M ED_DYM_0OOOO257
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`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 20 of 37 PageID #: 339
`Case 1:14—cv—01453—LPS Document 43-4 Filed 10/22/15 Page 20 of 37 PagelD #: 339
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`Application/Control Number: 10/518,016
`Art Unit: 1616
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`Page 4
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`4.
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`Restriction for examination purposes as indicated is proper because all these
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`inventions listed in this action are independent or distinct for the reasons given above
`
`E there would be a serious search and examination burden if restriction were not
`
`required because one or more of the following reasons apply:
`
`(a) the inventions have acquired a separate status in the art in view of their
`
`different classification;
`
`(b) the inventions have acquired a separate status in the art due to their
`
`recognized divergent subject matter;
`
`(c) the inventions require a different field of search (for example, searching
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`different classes/subclasses or electronic resources, or employing different
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`search queries);
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`(d) the prior art applicable to one invention would not likely be applicable to
`
`another invention;
`
`(e) the inventions are likely to raise different non—prior art issues under 35 U.S.C.
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`101 and/or 35 U.S.C. 112, first paragraph.
`
`Applicant is advised that the reply to this requirement to be complete must
`
`include (i) an election of a invention to be examined even though the requirement
`
`may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing
`
`the elected invention.
`
`The election of an invention may be made with or without traverse. To reserve a
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`right to petition, the election must be made with traverse. If the reply does not distinctly
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`and specifically point out supposed errors in the restriction requirement, the election
`
`M ED_DYM_0OOOO258
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`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 21 of 37 PageID #: 340
`Case 1:14—cv—01453—LPS Document 43-4 Filed 10/22/15 Page 21 of 37 PagelD #: 340
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`Application/Control Number: 10/518,016
`Art Unit: 1616
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`Page 5
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`shall be treated as an election without traverse. Traversal must be presented at the time
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`of election in order to be considered timely. Failure to timely traverse the requirement
`
`will result in the loss of right to petition under 37 CFR 1.144. If claims are added after
`
`the election, applicant must indicate which of these claims are readable on the elected
`
`invenflon.
`
`If claims are added after the election, applicant must indicate which of these
`
`claims are readable upon the elected invention.
`
`Should applicant traverse on the ground that the inventions are not patentably
`
`distinct, applicant should submit evidence or identify such evidence now of record
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`showing the inventions to be obvious variants or clearly admit on the record that this is
`
`the case. In either instance, if the examiner finds one of the inventions unpatentable
`
`over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C.
`
`103(a) of the other invention.
`
`Applicant is reminded that upon the cancellation of claims to a non-elected
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`invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one
`
`or more of the currently named inventors is no longer an inventor of at least one claim
`
`remaining in the application. Any amendment of inventorship must be accompanied by
`
`a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
`
`5.
`
`The examiner has required restriction between product and process claims.
`
`Where applicant elects claims directed to the product, and the product claims are
`
`subsequently found allowable, withdrawn process claims that depend from or otherwise
`
`M ED_DYM_0OOOO259
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`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 22 of 37 PageID #: 341
`Case 1:14—cv—01453—LPS Document 43-4 Filed 10/22/15 Page 22 of 37 PagelD #: 341
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`Application/Control Number: 10/518,016
`Art Unit: 1616
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`Page 6
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`require all the limitations of the allowable product claim will be considered for rejoinder.
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`fl claims directed to a nonelected process invention must require all the limitations of
`
`an allowable product claim for that process invention to be rejoined.
`
`In the event of rejoinder, the requirement for restriction between the product
`
`claims and the rejoined process claims will be withdrawn, and the rejoined process
`
`claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to
`
`be allowable, the rejoined claims must meet all criteria for patentability including the
`
`requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product
`
`are found allowable, an othen/vise proper restriction requirement between product
`
`claims and process claims may be maintained. Withdrawn process claims that are not
`
`commensurate in scope with an allowable product claim will not be rejoined. See MPEP
`
`§ 821 .04(b). Additionally, in order to retain the right to rejoinder in accordance with the
`
`above policy, applicant is advised that the process claims should be amended during
`
`prosecution to require the limitations of the product claims. Failure to do so may result
`
`in a loss of the right to rejoinder. Further, note that the prohibition against double
`
`patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement
`
`is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
`
`Telephone Election
`
`6.
`
`During a telephone conversation with Attorney Tom Pavelko on May 21, 2008 a
`
`provisional election was made without traverse to prosecute Invention I, claims 1-22,
`
`25-42 and 44-45. A provisional election of species of fluticasone was also made.
`
`MED_DYM_0OOOO260
`
`

`
`Case 1:14-cv-01453-LPS Document 43-4 Filed 10/22/15 Page 23 of 37 PageID #: 342
`Case 1:14—cv—01453—LPS Document 43-4 Filed 10/22/15 Page 23 of 37 PagelD #: 342
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`Application/Control Number: 10/518,016
`Art Unit: 1616
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`Page 7
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`Affirmation of this election must be made by applicant in replying to this Office
`
`action. Claims 23-24, 32-34, 39-42 and 46-52 are withdrawn from further consideration
`
`by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
`
`Status of Application
`
`Claims 1-42 and 44-52 are pending.
`
`Claims 23-24, 32-34, 39-42 and 46-52 are withdrawn from further consideration
`
`7.
`
`8.
`
`as being drawn to the non-elected invention.
`
`Claim Rejections - 35 USC § 112
`
`9.
`
`The following is a quotation of the second paragraph of 35 U.S.C. 112:
`
`The specification shall conclude with one or more claims particularly pointing out and distinctly
`claiming the subject matter whi