J1L-30-2002 TUE 0 1: 29 PM BSVU:XNO
`
`7'585
`FAX NO. 7r 958050
`
`P. 04
`.0
`
`PATENT
`2801-0162P
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFIC8
`
`Applicant:
`
`Robert X. SCHULTZ et al.
`
`conf.:
`
`Unknown
`
`App>, No.
`
`08/45S,280
`
`Group;
`
`1616
`
`Filed,
`
`For:
`
`may 31, 19,95
`
`Examiner; J.Dees
`
`SUSPENSION AEROSOL FOPVMUL-ATIONS
`
`1#49F
`#6KD
`q 9tb
`
`A"MMENT
`
`Assi.qtant Commissioner tor Patento
`Washington, VC 20231,
`
`30 July 2002
`
`Sir:
`
`The following amendments and remarks are respectfully submiitted.
`
`in connection with the above-identified application.
`
`ZTl THER CLAIMS:
`
`Please ca cel clai-m 109 4nd 118-121.
`
`The claims have been amended to read as follows:
`
`4106. (Amended) The pharmaceutica
`e drug com-prises a drug selected
`
`of claim 105, wherein the particul
`
`suspenoion aerosol formulation
`
`from the group consisting of form terol, beclomethasone dipropioaate,
`
`pirbuterol, 41buterol, and ph maceutically acceptable
`
`salts
`
`and
`
`solvates thereof.
`
`07/30/02 TUE 13:30 [TX/RX NO 96541
`
`Mylan EX 1005, Page 1
`
`
`
`
`
`7'585
`FAX NO. 7r 958050
`
`P. 04
`.0
`
`PATENT
`2801-0162P
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFIC8
`
`Applicant:
`
`Robert X. SCHULTZ et al.
`
`conf.:
`
`Unknown
`
`App>, No.
`
`08/45S,280
`
`Group;
`
`1616
`
`Filed,
`
`For:
`
`may 31, 19,95
`
`Examiner; J.Dees
`
`SUSPENSION AEROSOL FOPVMUL-ATIONS
`
`1#49F
`#6KD
`q 9tb
`
`A"MMENT
`
`Assi.qtant Commissioner tor Patento
`Washington, VC 20231,
`
`30 July 2002
`
`Sir:
`
`The following amendments and remarks are respectfully submiitted.
`
`in connection with the above-identified application.
`
`ZTl THER CLAIMS:
`
`Please ca cel clai-m 109 4nd 118-121.
`
`The claims have been amended to read as follows:
`
`4106. (Amended) The pharmaceutica
`e drug com-prises a drug selected
`
`of claim 105, wherein the particul
`
`suspenoion aerosol formulation
`
`from the group consisting of form terol, beclomethasone dipropioaate,
`
`pirbuterol, 41buterol, and ph maceutically acceptable
`
`salts
`
`and
`
`solvates thereof.
`
`07/30/02 TUE 13:30 [TX/RX NO 96541
`
`Mylan EX 1005, Page 1
`
`
`
`
`
`JUL-30-20027T1JE 01:28 PM BSKeP
`
`FAX NO. 70?7f58050
`
`P. 05
`
`Application No. 08145-5,280
`Art Unit 1616
`
`10)8.
`
`(Amended) The pharmaceutical
`
`ispension aerosol formulation
`
`of claim 105, wherein the drug
`
`is tar oterol or a
`
`pharmaceutically
`
`acceptable salt thereof.,
`
`I esetially of
`
`116. (Amended) A pharmaceutical aero ol formulation consisting
`or a
`albute-rol
`ich i's
`'drug
`
`a particulate
`
`physiologi cally acceptable salt or so vate thereof and 1,1,1,2-
`
`tetrafluorqethane as propellant, whi-ch formulation
`
`is
`
`substantially
`
`tree of surf actant,
`
`the particulat
`
`drug being present in a
`
`therapeuatically effective amount of I ss than 1.6% w/w relative
`
`to
`
`the total weight of
`
`the formulation
`
`nd wherein 90% or more of the
`
`particles have a diameter of less thaL 10 microns.
`
`117.
`
`(Amended)
`
`A
`
`canister
`
`suitable
`
`for
`
`delivering
`
`a
`
`pharmaceutical aerosol formulatio
`
`for inhalation therapy which
`
`comprises a container capable of
`
`ithstanding the vapor pressure of
`
`the propellant used, which contai er is closed with a metering valve
`
`and contains
`
`a
`
`pharmaceutica
`
`aerosol
`
`formulation consistiihg
`
`essentially of
`
`a particulate dr-ug
`
`which i 2
`
`alb-utQrol
`
`or, a
`
`physi-ologically acceptable sal
`
`or solbtate thereof and1,,2
`
`tetrafluoroethane as 'propellant, which formulation
`
`is
`
`substantially
`
`free
`
`of surfactant,,
`
`the pa ticulate drug being present
`
`in a
`
`therapeutically effective amou
`
`t of
`
`less than 1-6% w/w relative
`
`to
`
`-2-
`
`07/30/02 TIUE 13:30 [TX/RX NO 9654]
`
`Mylan EX 1005, Page 2
`
`
`
`JUL-30-2002,TUJE 01:28 Ff1 ESKQ.
`
`FAX NO. 707')n58050
`
`P. 05
`
`Application No. 08/45.5,2890
`Art Unit .2616
`
`108. (Amended) The pharmaceutical
`
`spension aerosol formulation
`
`of claim 105, wherein-the drug
`
`is fcr oterol or a
`
`Pharmatceutically
`
`acceptab)le salt thereof.,
`
`5
`
`116.
`
`(Amended)
`
`A pharmaceutical aero ol formulation consisting
`
`essBentially of
`
`a
`
`particulate drug
`
`ich is
`
`aTbuterol or
`
`a
`
`physiologically acceptable salt or so vate thereof and 1,1,1,2-
`
`tetrafluorQethane as propellant, whi.:h formulation
`
`is
`
`substantially
`
`free of surfactant, the partic-ula.t
`
`drug being present in a
`
`therapeutically effective amount of 1 zs
`
`than 1.6% w/w relative to
`
`the total weight of
`
`the formulation
`
`nd wherein 90% or more of
`
`the
`
`particles have a diameter of lesp thaL 10 microns.
`
`11-7,
`
`(Amended)
`
`A
`
`canister
`
`suitable
`
`for
`
`delivering
`
`a
`
`pharmaceutical aerosol formulatio
`
`for inhalation t herapy which
`
`comprises a container capable of
`
`ithstanding the vapor pressure of
`
`the propellant used, which contai ier is closed with a metering valve
`
`and
`
`contains
`
`a
`
`pharmaceutica
`
`aerosol
`
`formulation consistiihq
`
`essentially
`
`:of
`
`a particulate drug which is
`
`alb-Utprol
`
`or a
`
`physiologically accreptable sal
`
`or Sol-vate thereof and 1,1,1,2.
`
`tetrafluoroethane as 'propellant, whichi
`
`tormulation
`
`is
`
`substantially
`
`free
`
`Of surtactanTt,, the
`
`pa ticuilate drug being present
`
`in a
`
`therapeutically effective amou t of less
`
`than 1-6%; w/w relative
`
`to
`
`-2-
`
`07/30/02 TUE 13:30 [TX/RX NO 96541
`
`Mylan EX 1005, Page 3
`
`
`
`JUL-3D 2002 TUE 01:28 PM USKB
`
`7FAX NO. 7032058050
`
`F, OB
`
`Vr
`
`th total weight of
`the formulation and
`particles have a diameter of less than 4
`
`APPlIication SO. 08/455,280
`Art Unit 1616
`
`122. (Amnended)
`
`Lical
`
`formu4lation
`
`consisting
`
`icu Ee drugs,
`
`and, (iiW
`
`,112
`
`tetrafluoroethane
`
`'as propellant, wh.
`
`ich for-mul ation js substantially
`
`f ree of
`
`surfactant, the particul
`
`o e drug being presqent in a
`
`therapeutically effective amounzt
`
`lee
`
`*than
`
`1.G-W w/w relative to the
`
`total weight of
`
`the formulatin
`
`dwherein 90* or more of
`
`the
`
`particles have a diameter of less
`
`an 10 microns, wherein one of the
`
`said one or more part .iculate drug/i
`
`.s a bronchadilator selected from
`
`the
`
`group
`
`consisting
`
`It.erol
`
`and
`
`pirbute-rol
`
`or
`
`a
`
`Pleagse add the following claims:
`
`123. (New)
`
`A pharmaceutica suspension formulation suitable
`
`fotr aerosol administration consiati g essentially of:
`particulate drug; and
`
`Wi
`
`(ii) l,1,l,2-tetrafluoroetha e asj propellant,
`
`wherein the formulation is subst ntiaJ.ly free at surfactant,"
`
`124.
`
`(New) The pharmaceu ical suspension aerosol formulation of
`
`claim 123, wherein the, dru. is albuterol or a pharrr4cceutic4lly
`
`acceptable salt or solvate th reaf-
`
`-3-
`
`07/30/02 TLIE 13:30 [TX/RX NO 9654]
`
`Mylan EX 1005, Page 4
`
`
`
`JUL-30-2002 TUE 01:28 PM HSKB
`
`FAX NO. M2058060
`FXN.72085
`
`P, 06
`.O
`
`the totftl weight of
`
`the formulation and herein 90A or more of the
`
`particles have a diameter of .-.ess than 1
`
`microns.
`
`App4cat!Qx2 No. 08/455,280
`Art Unit 16146
`
`~4122.
`
`(Amended)
`
`A
`
`essentially of (i one or more particu
`
`pharmaceutical
`
`formulation
`
`consisting
`
`te drugs, and (ii) I,I,j1,2-
`
`tetraflooroethane
`
`'as propellant, which formulation
`
`i's substantially
`
`free of
`
`surfactant, the particula e drug being present
`
`in a
`
`therapeutically effective amount les
`
`than 1.6-W w/w relative
`
`to the
`
`total
`
`weight of
`
`the
`
`formulation
`
`d wherein 90% or more of the
`
`particles have a diameter of less t aa 10 microns, wherein one of the
`
`said one or more particulate drug
`
`is, a bronchodilator selected from
`
`the
`
`group
`
`consisting
`
`of
`
`f rmotxerol
`
`and
`
`pirb-uterol
`
`or
`
`a1
`
`physiologically acceptable oalt hereof.
`
`-SI.
`
`Please add the following claims:
`
`123. (New)
`
`A pharmaceutica suspension formulation suitable
`
`for aerosol administration consisti g essentially of.
`
`Wi
`
`particulate drug; and
`
`(ii) 1,1,1,2-tetrafluoroetha e as propellant,
`
`wherein the formulation is subst ntially tree of surfactant."
`
`124.
`
`(New) The pharmaceu ical suspension aerosol formulation of
`
`claim 123, wherein the, dru. is albuterol or a pharm4tceutically
`
`acceptable salt,or solvate th reof.
`
`-3-
`
`07/30/02 TUE 13:30 [TX/RX NO 9654]
`
`Mylan EX 1005, Page 5
`
`
`
`JUL-30-2002' TUE 0 1 :28 Pfl'BSKAPO.7lfl5Q
`
`FAX NO, 7- 1068050
`
`P. 07
`.0
`
`Application No. 08/455,280
`A-rt Unit 1616
`
`125.
`
`(New) The -pharmaceutical S tSPen0jon ae-rosol formulation of
`
`ClaiM 123, wherein the drug is albu e-ol 11Sul fate.
`
`07/30/02 TUE 13:30
`
`[TX/RX NO 96541
`
`Mylan EX 1005, Page 6
`
`
`
`JUL-30-2002 TUE 01:29 PM BSKB,.
`
`FAX NO. 7031?P58050
`
`P. 08
`
`Application No. 08/455,280
`Art Unit .16216
`
`RRMRKlS
`
`Claims 106,
`
`108,
`
`115, .117 and 122 are amended.
`
`claims 109 and
`
`118-121 are canceled.
`
`Claims 123-125 are added.
`
`No new matter
`
`is
`
`inserted into thb application.
`
`Claim 106 has been amended to delete reference to,oev\,eral drugs.
`
`Consideration will be given as
`
`to whether
`
`these drugs should be
`
`included
`
`in
`
`a different application. Claim 108 has been amended
`
`to
`
`delete reference to "solvates" of formoterol, since the specification
`
`does3 not mention solvates ot this particular drug.
`
`Claims 115, 117?, and 122 have been amended,in order to use terms
`
`that have better support
`
`in
`
`the specification-
`
`Support
`
`fo0r the
`
`amendments
`
`to these claims and the new claimrs can be found
`
`in the
`
`specification at page 6,
`
`lines 1-4 anid 24-27, and page 12,
`
`lines 33-
`
`37.
`
`It
`
`is noted
`
`that "albuterol", and "sal.butarnol" are
`
`the
`
`same
`
`drugs.
`
`"Albuterol", is
`
`a name commonly used in
`
`the United'States and
`
`"Isalbutamol" is
`
`a name commonly usedL
`
`in
`
`the United Kingdom.
`
`Since
`
`"albuterol" is
`
`the term used
`
`in
`
`the s3pecification,
`
`this 'game term is
`
`used in the claims.
`
`Pe.rsonal Intax-view
`
`Applicants acknowledge with appreciation the personal interview
`
`which was. conducted on July 24,
`
`2002.
`
`In particular, Applicants
`
`appreciate
`
`the fact
`
`that
`
`the Examiner
`
`took
`
`time
`
`to consider
`
`the!
`
`related
`
`interference,
`
`tile
`
`prior
`
`to
`
`the
`
`interview. Applicanits'
`
`-5-
`
`07/30/02
`
`TUE 13:30
`
`[TX/RX NO 96541
`
`Mylan EX 1005, Page 7
`
`
`
`JUL-30-2002 TUE 01:29 PM,BSKP
`
`FAX NO. 7r--r)58060
`
`P. 09
`
`Application No,!08/455,280
`Art Unit 2616
`
`represent ati-ve offered, to file
`
`relevant papers
`
`from the interference
`
`tile
`
`in
`
`this application tar the Examiner's convenience.
`
`However,
`
`the Examiner indicated' that since he had already reviewed the
`
`interference
`
`file,
`
`it was not necessary to file
`
`copies of :the papers
`
`in
`
`this tile,
`
`Applicants appreciate
`
`the Examiner's will ingness
`
`to
`
`consider possible ,claim amendments
`
`to place
`
`the claims
`
`into better
`
`condition tar allowance, while at the same time affording the
`
`Applicants appropriate protection for the invention disclosed in
`
`the
`
`specification. Applicants have given careful attention to the points
`
`raised by
`
`the Examiner,
`
`and submit. this amendment
`
`in
`
`an effort
`
`to
`
`place this application in condition for allowance with miniimal
`
`inconvenience to the Examiner.
`
`The Examiner Inter-view Summary,
`
`Record, together with the additiondt
`
`:cemarks in this Amendment,
`
`s3ummarize the main points discussed at, the interview.
`
`I.afornation Di.9closure statements
`
`An, Inf ormat Iion Disclosure Statement (IDS) was filed July 24,
`
`2002, The Examiner
`
`is
`
`requested to initial
`
`the PTO 1449 attached to
`
`that IDS and, return the iTlitl.aled Copy
`
`to the undersigned with the
`
`next communication
`
`from
`
`the USPTO,
`
`In addition,
`
`the Examiner
`
`is
`
`requested
`
`to initial
`
`the PTO-1449 forms submitted with the IDS
`
`tiled
`
`on December 8, 1998
`
`'(Exhibit J, attached to the Amenidmpent
`
`tiled on
`
`December 8,
`
`1998)
`
`and on April 12,
`
`1999
`
`(Paper No.
`
`31).
`
`It appears
`
`that an E-nglish translation of one of the Previously filed references
`
`07/30/02 TUE 13:30 [TX/RX NO 9654]
`
`Mylan EX 1005, Page 8
`
`
`
`JUL-30-2002 TUE 01:30 PM IBSK,,.
`
`FAX NO. 703?058050
`
`F. 10
`
`Application 2fo. 081455,280
`A.rtE Un it 16.26
`
`(SE 437766) may not have been previously tiled,
`
`An English
`
`translation of
`
`this reference was slibmitted with
`
`the
`
`ILDS
`
`f-ied on
`
`July 24, 2002 and this reference was listed again on the accompanying
`
`PTO-1449. It ip' submitted that the references filed
`
`on July 24, 2002
`
`do not affect the patentability of the! pending3 claims.
`
`Claim Amendments and Cancellations
`
`As dicussed at the interview,
`
`thes pT.esent invention is directed.
`
`to a pharmaceutical suspension formulation suitable for aerosol
`
`administration Consisting essentially of paLrticulate
`
`drug and
`
`1,1, 1,2-tetratfluoroethane as propellant.
`
`As described
`
`in
`
`the specification,
`
`a single drug or various
`
`drugs can be used. in
`
`the formulation, oee for example the paragraph
`
`bridging pages
`
`'7 and 8 of the specification and pre vioujsly allowed
`
`claim 122, Pending claimn
`
`such as claims 105 and 123 covrer both of
`
`these situations.-
`
`The characteristic feature of the presently claimed invention is
`
`that a surfactant is not neceasary to stabilize a suspension of
`
`particulate drug
`
`(which can include one or more driigs) and 1,1,1,2-
`
`t Ietrafluoroethane
`
`(134a)
`
`in order to make
`
`the formulation suitable
`
`for aerosol administration, This was truly surprising based on the
`
`collective teachings of the prior art. which taught the importance of
`
`using a surfactant
`
`to make a pharmaceutical
`
`formulation which was
`
`suitable for aerosol administration.
`
`The presently pending claims
`
`-7-
`
`07/30/02 TUE 13:30 [TX/RX NO 9654]
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`Mylan EX 1005, Page 9
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`
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`JUL-30-2002 TUE 0 1 :30 PMl BSKP-
`
`UXN.7ffQ~5
`FAX NO. 7100580SO
`
`.1
`P. I I
`
`Application No. 08/455,280
`Art Unit 1616
`
`emphasize
`
`this tact by indicating
`
`that 'the formulation
`
`is
`
`free of
`
`surfactant
`
`(claim 105) or substantially: tree of surfactantc (claim
`
`123).
`
`The addition of claim 12$?: using the term "substantially free
`
`of Burfactant" ,was discussed at the interview as noted
`
`in
`
`the
`
`Examiner Tnterview Summary Record.
`
`Claim 108 has, been amended to, delete reference to "solvates" of
`
`formoterol, since the specification does not mention sollvates of this
`
`particular drug.
`
`Claims 1-16,
`
`117' and 122 have been arpended.
`
`As discussed at the
`
`interview,
`
`it
`
`is
`
`respectfully submitted :that
`
`these claims' should be
`
`amended before a Notice of Allowance
`
`ip
`
`issued so
`
`that
`
`the claim
`
`language more closely tracks the disciosutre in the specificaLti,
`
`In
`
`particular,
`
`the Examiner indicated
`
`th,-at he would allow amendment of
`
`these claims
`
`to use
`
`the term I'substanti4lly free 'of aurfactant", as
`
`this term was Used
`
`in
`
`the specification.
`
`Additional amendments have
`
`also been made to these claims in order 'to present claims which more
`
`closely track
`
`the
`
`language of
`
`the spec:ificatiri.
`
`As noted in
`
`Applicants' Amendment filed on
`
`Djecemb= :er 8, 1998, these claims
`
`correspond
`
`to certain claims of Glaxo patents.
`
`These claims were
`
`submitted solely for the purpose of pro voking an interfe rence with
`
`these patents- (See page 6 of the Amendme: nt filed December 8, 1998),
`
`However,
`
`in view of the termination of :Interference No.
`
`104,636
`
`in
`
`favor of Schult2 et al by agreement! of the involved parties,
`
`07/30/02 TUE 13:30 fTX/RX NO 9654]
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`Mylan EX 1005, Page 10
`
`
`
`JUL-30-2002 TUE 01:30 FP1 BSKP
`
`~
`
`FAX NO. 7r")058050
`O ~085
`
`P, 12
`.1
`
`allowance of these cla'ims
`
`in
`
`the present application is believed
`
`to
`
`Application AVo. 08/455,280
`Art: Unit: 1616
`
`be appropriate.
`
`Con clugion
`
`For the foregoing reasons, it is respectfully submitted that the
`
`present application is now in condition for allowance.
`
`Should there -be any outstanding matters that need to be resolved
`
`in
`
`the present
`
`application,
`
`the Examiner
`
`is
`
`respectfully requested to
`
`contact the undersigned at the telephc)ne number below.
`
`if necessary,
`
`the Commissioner
`
`is hereby authorized
`
`in
`
`this,
`
`concurrent,
`
`and future replies,
`
`to charge payment or credit any
`
`overpayment
`
`to Deposit Account No.
`
`02-2448 tar any additional
`
`fees
`
`required under 37 C.F-R. 5 1J1G or under 37 C.F.R. q~1:7
`
`particularly, extension of time fees-
`
`1;h
`
`fuVkO of Tionm40on
`N*Cedify that this cwrrspwndmnce is being
`I18tRnsMWttkPatmntuand
`
`Respectfully submitted,
`
`BIRCH, STEWART, KOLASCH & BIRCH, LLP
`
`II
`fradn"A
`
`hs~ ~
`
`Tpe ortMcdd rwit ofl wugmg witioW
`
`GMM/ KLJR
`2801-0162P
`
`By CR att49-v7
`Gerald M. Murphy, Jr.-,
`
`-#28,977
`
`P.0, Box 747
`Falls Church, VA 22040-0747
`(703) 205-8000
`
`Attachments;
`Marked-up Version Showing Changes; Made
`Clean Set of all Pending claims for Hxaminer's Convenience
`
`037/30/02 TUE 13:30 [TX/RX NO 9654]
`
`Mylan EX 1005, Page 11
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