3M Attorney Docket No. 47982USA5C
`Attorney Docket No. 03196.0019-00000
`
`IN TIIF UNITED STATES PATENT AND TRADEMARK OFFICE
`
`10
`-/7-
`
`/1Z
`
`Rule 1. 129(a) Submission of:
`
`.-
`
`Robert K. Schultz et al.
`
`Group Art Unit: 1615
`
`Examiner: G. Kishore, Ph.D.
`
`Serial No. 08/455,280
`
`Filed: May 31, 1995
`
`For:
`
`SUSPENSION AEROSOL
`FORMULATIONS
`
`Assistant Commissioner of Patents
`Washington, D.C. 20231
`
`Second Submission Under 37 C.F.R. § 1.129(a) and
`Request That an Interference Be Declared Under 37 C.F.R. § 1,607
`
`This submission is being made pursuant to 37 C.F.R. § 1.129(a) and 37 C.F.R.. § 1.607.
`
`The requisite fee under 37 C.F.R. § 1. 17(r) and any extension fee under 37 C.F.R. § 1.1 36(a) are
`
`attached. Prior to examination of this submission, and for purposes of declaring an interference,
`
`please amend the above-identified application as follows:
`
`12/10/1998 TLW1Jl
`03 FC:146
`
`I IJNE(-AN, HENDERSON,
`FARABOW, GARRETT,
`8 DUNNER,L.L,P.
`1300 1 STREET, N. W.
`WAS HINO3TON, OC 20005
`202-408-4000
`
`D0000029 08455280
`760.00 UP/
`Please cancel claims 30, 1-101, and 103-104. Please add the following new claims:
`
`I3 THE CLAIMS
`
`1.
`
`--0.Apharmnaceutical suspensi
`
`formulation suitable for aerosol administration
`
`consisting essentially of:
`
`00000029 085.0 0 OP
`
`REPLACEMENT Mylan EX 1004, Page 1
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`

`
`(i)
`
`(ii)
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`particulate drug; a
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`1,1,1 ,2-tetrafluo oeth ane as propellant, wherein the formulation is further
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`08/455,280
`
`4.
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`characterized in that it contains no s /rfactant.
`
`106.
`
`The pharmaceutical su pension aerosol formulation of claim 105, wherein the
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`particulate drug comprises a drug selec dfrm the group consisting of formoterol, salmeterol,
`
`beclomethasone dipropionate, cromolyn,
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`irbuterol, albuterol, and pharmaceutically acceptable
`
`salts and solvates thereof.
`
`107.
`
`The pharmaceutical suspension aer ol formulation of claim 105, wherein the
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`particulate drug is micronized.
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`108.
`
`The pharmaceutical suspe
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`ion aerosol formulation of claim 105, wherein the
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`drug is formoterol or a pharmaceutically \acc
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`table salt or solvate thereof.
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`109.
`
`The pharmaceutical suspen in aerosol formulation of claim 105, wherein the
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`drug is salmeterol or a pharmaceutically a
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`table salt or solvate thereof.
`
`11 0. The pharmaceutical suspension aerosol
`
`rmulation of claim 1 05, wherein the
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`drug is albuterol or a pharmaceutically acceptable sal or solvate thereof.
`
`1ll.
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`The pharmaceutical suspension aer ol formulation of claim 105, wherein the
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`drug is beclomethasone dipropionate or a phar
`
`ceutically acceptable solvate thereof.
`
`112.
`
`The pharmaceutical suspensio aerosol formulation of claim 105, wherein the
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`drug is pirbuterol or a pharmaceutically acc ptable salt or solvate thereof.
`
`113.
`
`The pharmaceutical suspe
`
`ion aerosol formulation of claim 110, wherein the
`
`drug is albuterol sulfate.
`
`,-AW OFFICES
`NNJEGAN, HENDERSON,
`F ARASQW, GARRETT,
`& 1)uNNER,L,..L. P.
`1300 1 STRE:ET, N. W.
`zVASPIINGT0N, DC 20005
`202-408 4000
`
`2
`
`
` REPLACEMENT MYLAN Ex. 1004, Page 2
`
`

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`114.
`
`Trhe pharmaceutical suspensi
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`aerosol formulation of claim 112, wherein the
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`08/455,280
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`drug is pirbuterol acetate.
`
`115. An aerosol canister equ* ped with a metering valve, containing a formulation
`
`according to claim 105 in an amou
`
`sufficient to provide a plurality of therapeutically effective
`
`doses of the drug.
`
`'/
`
`*'v
`
`116. A pharmaceutical aero
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`I formulation consisting essentially of a particulate
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`medicament which is sal uit
`
`ol or a p ysiologically acceptable salt or solvate thcreof and
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`1,1,1 ,2-tetrafluoroethane as propellant,
`
`ich formulation contains less than 0.000 1% surfactant
`
`based upon the weight of medicament, the particulate medicament being present in an amount of
`
`0.005% to 5% w/w relative to the total wei hit of the formulation and having a particle size of
`
`less than 100 microns, with the provisos tha when said formulation consists of salbutamnol and
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`1,1,1,2-tetrafluoroethane in a weight ratio of 05:18, said salbutamol is present in the form of a
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`physiologically acceptable salt and when said
`
`rmuiation consists of salbutamol or salbutamol
`
`sulphate and 1,1,1 ,2-tetrafluoroethane the weigh to weight ratio of muedicament to propellant is
`
`other than 69:7900 or 0.866%.
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`117. A canister suitable for delivering a p armaceutical aerosol formulation for
`
`inhalation therapy which comprises a container capa e of withstanding the vapor pressure of the
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`propellant used, which container is closed with a meter g valve and contains a pharmaceutical
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`aerosol formulation consisting essentially of a particulat medicament which is salbutamol or a
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`physiologically acceptable salt or solvate thereof and 1,1,1
`
`-tetrafluoroethane as propellant,
`
`which formulation contains less than 0.0001% w/w surfacta based upon the weight of
`
`3
`
`L-AW OFPrICES
`
`I INNWI-CAN, HENDER50N,
`ARABIOW, GARRETT,
`8~ DIJNNFR,L. L. P.
`300 1 STREETp N. W.
`WASHINGTON, DC 20005
`202-408-4000
`
` REPLACEMENT Mylan Ex. 1004, Page 3
`
`

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`08/455,280
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`medicament, the particulate medica
`
`ft being present in an amount of from 0.005 to 5% w/w
`
`relative to the total weight of the form ation and having a particle size of less than 100 microns,
`
`and with the provisos that when said fo
`
`ulation consists of salbutamol and 1,1 ,1,2-
`
`tetrafluoroethane in a weight ratio of 0.05:
`
`, said salbutamol is present in the form of a
`
`physiologically acceptable salt and when sai formulation consists of salbutamol or salbutamol
`
`sulphate and 1 ,1,1 ,2-tetrafluoroethane the weig t to weight ratio of medicament to propellant is
`
`other than 69:7900 or 0.866%.
`
`118. A pharmaceutical ae osol formulation consisting essentially of particulate
`
`medicament which is fluticaso 4 pro ionate or a physiologically acceptable solvate thereof, and
`
`1,1,1 ,2-tetrafluoroethane as propellant which formulation contains less than 0.0001% w/w
`
`surfactant based upon the weight of me icament, the particulate medicament being present in an
`
`amount of from 0.005% to 5% w/w relat e to the total weight of the formulation and having a
`
`particle size of less than 100 microns.
`
`119. A canister suitable for del
`
`'ng a 4rrnaceutical aerosol formulation which
`
`comprises a,container capable of withsta
`
`i
`
`the vapor pressure of the propellant used, which
`
`container is closed with a metering valve and
`
`tains a pharmaceutical aerosol formulation
`
`consisting essentially of a particulate medicamen which is fluticason &propionate or a
`
`physiologically acceptable solvate thereof and 1,1, 2-tetrafluoroethane as propellant, which
`
`formulation contains less than 0.0001% w/w surfact
`
`t based upon the weight of medicament,
`
`the particulate medicament being present in an amoun of from 0.005 to 5% w/w relative to the
`
`total weight of the formulation and having a particle siz of less than 100 microns.
`
`4
`
`REPLACEMENT Mylan Ex. 1004, Page 4
`
`-AW OFFCES
`INNLCGAN, I IENDFERSON,
`FARABOW, GARRETTf,
`8~ DUNNFR,L. L.P.
`1300 1 STREFT, N. W.
`WAS HI NGTONI DC 20005
`202-408-4000
`
`

`
`08/455,280
`
`120. A pharmaceutical erosol formulation consisting essentially of a particulate
`
`medicament which is sailfiete?,oi or physiologically acceptable salt or solvate thereof and
`
`1,1,1,2-tetrafluoroethane as propelI
`
`t, which formulation contains less than 0.0001% w/w
`
`surfactant based upon the weight of edicament, the particulate medicament being present in an
`
`amount of from 0.005 to 5% w/w relat ye to the total weight of the formulation and having a
`
`particle size of less than 100 microns.
`
`121.
`
`A canister suitable for e
`
`ng a pharmaceutical aerosol formulation for
`
`inhalation therapy which comprises a o ainer capable of withstanding the vapor pressure of the
`
`propellant used, which container is closed
`
`ith a metering valve and contains a pharmaceutical
`
`aerosol formulation consisting essentially
`
`a particulate medicament which is salmeterol or a
`
`physiologically acceptable salt or solvate th reof and 1,1,1,2-tetrafluoroethane as propellant,
`
`which formulation contains less than 0.000 1' w/w surfactant based upon the weight of
`
`medicament, the particulate medicament bein present in an amount of rom 0.005 to 5% w/w
`
`relative to the total weight of the formulation a
`
`having a particle size of less than 100 microns.
`
`122. A pharmaceutical formul
`
`ion consisting essentially of (i) one or more particulate,,
`
`medicaments, and (ii) 1, 1, 1,2-tetrailuoroet ane as propellant, which formulation contains less
`
`than 0.0001% w/w surfactant based upon th weight of medicament, the particulate medicament
`
`being present in an amount from 0.005 to 5% /w relative to the total weight of the formulation
`
`and having a particle size of less than 100 micro s, wherein one of the said one or more
`
`medicaments is a bronchodi lator selected from the
`
`roup consisting of ephedrine, adrenaline,
`
`fenoterol, formoterol, isoprenaline, metaproterenol,
`
`enylephrine, phenylpropanolami ne,
`
`5
`
`INNEGFfANJ, HEN DERSON,
`1-ARABOW, GARRETTl;
`8s DUNNER,[-.L.P.
`1300 1 5TREIE, N. W.
`WASHINGTON, DC 20005
`202-408-4000
`
`REPLACEMENT Mylan EX 1004, Page 5
`
`

`
`§ ~
`
`pirbuterol, reproterol, rimiterol, terbuta. *ne, isoetharine, tulobuterol, orciprenaline or ()4
`
`,5-dichloro-c- [[16- [2-(2-pyridiny\ ethoxyjhexyl]amino]methyl benzenemethanolI or a
`~amino-3
`
`physiologically acceptable salt thereof--
`
`REMARKS
`
`1.
`
`Applicants' Present Submpission
`
`The present submission is applicants' second submission uinder 37 C.F.R. § 1. 129(a) iin
`
`U.S. Application No. 08/45 5,280. New claims 105-115 are directed to a pharmaceutical
`
`suspension aerosol formulation consisting essentially of particulate drug and 1,1,1 ,2-
`
`tetrafluoroethane as propellant, wherein the formulation contains no surfactant and is suitable for
`
`aerosol administration. Claims 105-115 are allowable over the prior art of record and are
`
`directed to the same patentable invention as claimed in several issued U.S. patents identified
`
`below. Claims 116-122 are copied from claim I of each of the interfering patents and are
`
`presented here solely for the purpose of provoking an interference.
`
`Applicants thank Examiner Kishore for the courtesies extended during a personal
`
`interview on September 4, 1998. During that interview, the applicants disclosed their intent to
`
`provoke an interference as set forth in more detail below.
`
`I-AW Orr,ICES
`
`F NNEGAN, H ENDERSON,
`IARABow, GARREITF,
`8 DUNNER, L. L.P.
`1300 I 5TREET, N. W.
`yASHINGTON70D 20005
`202-40e -4000
`
`6
`
`REPLACEMENT Mylan EX 1004, Page 6
`
`

`
`08/455,280
`
`1. The Pending Claims, with No Surfactant in the
`Formnulation Are Directed to Allowable Subject Matter
`
`New Claims 105-115 Are Allowable over
`Previouqly Cited Prior Art
`
`The canceled claims were rejected under: (1) 35 U.S.C. § 102(e) as being
`
`anticipated by Byron et at., U.S. Patent No. 5,190,029 (the '029 patent) (claims 3 0, 64-7 1,
`
`85-87, 93-94); (2) 35 U.S.C. § 103 as being obvious over Byron (claims 30, 61-101 and
`
`103-104); (3) 35 U.S.C. § 103 as being obvious over Schultz et al., WO 91/14422 (claims
`
`30, 61 -101 and 103-104); and (4) 35 U.S.C. § 103 as being obvious over Byron inl view
`
`of Schultz (claims 61-63, 71-72 and 82-92). $ee Office Action of 12/12/97. To the
`
`extent the previous rejections remain applicable to new claims 105-1 15, applicants
`
`respectfully traverse the Examiner's rejections.
`
`As noted during the interview of September 4, 1998, applicants' claimns are now
`
`expressly directed to formulations that exclude surfactant, thereby overcoming the
`
`previous 35 U.S.C. § 102(e) rejection in view of the '029 patent (Byron), Byron
`
`expressly requires the presence of a surfactant. Byron's specification uniformly discloses
`
`formulations that include surfactant. See. e.g., Col. 2, lines 64-68 (object of the invention
`
`is to provide MDT formulations that "include a drug and a surfactant"), Indeed, all test
`
`formulations contain surfactant (cot. 4, lines 48-52), all working examples require
`
`surfactant (col. 3, lines 6-12), and the abstract expressly recites the use of surfactant.
`
`The Examiner relies, inter alia, on claim 1 of the '029 patent as a teaching of'a
`
`surfactant-free formulation because the claim does not specify a surfactant. H-owever, the
`
`7
`
`LAw OFricES
`
`INJN)IC!AN, I IENDER5ON,
`I'ARAB OW, GARRETT
`8 DUNNER,L.L.P.
`300 1 STREF-T, N. W.
`WASHI NQTON, DC 20005
`202 408-4000
`
`REPLACEMENT Mylan EX 1004, Page 7
`
`

`
`claims of the '029 patent are directed to an apparatus, whereas claim 1 of Bryon' s parent
`
`application, U.S. Patent No. 5,1 82,097, is directed to an aerosol formulation which
`
`expressly recites a surfactant. The Examiner's argument with respect to claim 1 of the
`
`08/455,280
`
`patent discloses. Although applicants recognize that claims can constitute disclosure in
`
`certain circumstances, the Court of Appeals for the Federal Circuit has held that while thc
`
`scope of a patent's claims determines what infringes the patent, it is no measure of what
`
`the patent discloses. In re Benno, 768 F.2d 1340, 1346, 226 U.S.P.Q.2d 683, 686 (Fed.
`
`Cir. 1985) (reversing a PTO rejection based on the language of a patent claim).
`
`Following the reasoning and holding of In re Benno, the fact that claim 1 of thc '029
`
`patent does not recite surfactant does not justify excluding surfactant from the '029
`
`patent's disclosure when every discussion, formulation, and working example in Byron
`
`includes the use of surfactant.
`
`Accordingly, for all of the above reasons, the rejection under 35 U.S.C. § 102(e)
`
`based on Byron is overcome.
`
`The previously pending claims were also rejected under 35 U.S.C. § 103(a) as
`
`obvious over the '029 patent. The Examiner has asserted that even if the Byron reference
`
`does require surfactant, it would be pXLnmA facie obvious to manipulate the basic teachings
`
`of Byron to exclude surfactant with the expectation of obtaining similar results. See
`
`Office Action of 12/12/97. This conclusion is unsupported by any teaching or suggestion
`
`LAW OFFICES
`
`liiNNEcAN, HFNDERSON,
`I ARABOW, GARRETT
`A DtJNNER,L.L.P.
`$,300 I 8TRET, N. W,
`WASHINGTON, OC 20005
`202-405-4000
`
`8
`
`REPLACEMENT Mylan EX 1004, Page 8
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`

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`08/455,280
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`found in the '029 patent, and disregards the conventional wisdom at the time of the
`
`invention that surfactants are desirable components of suspension aerosol formulations.
`
`Byron's consistent disclosure of the inclusion of surfactant plainly indicates to
`
`one skilled in the art that Byron considered surfactant to be a necessary ingredient of his
`
`aerosol 'formulations, and teaches away'from the elimination of surfactant from his
`
`formulations. Although the patent discusses the possibility of varying the amount of drug
`
`and surfactant in order to achieve inhalation drug delivery (cot. 3, lines 9-12) this is in no
`
`way a teaching that one could eliminate surfactant altogether. Further, the patent's
`
`disclosure of formulations having "reduced" surfactant levels (col. 6, lines 22-25) is not a
`
`basic teaching of how to exclude surfactant entirely and obtain a formulation suitable for
`
`aerosol administration. The Byron patent is entirely devoid of any teaching which
`
`suggests or motivates the skilled artisan to exclude surfactant,
`
`Byron co-authored an article which explicitly sets forth his view that surfactant
`
`was a required component of an aerosol formnulation for a metered dose inhaler (MDI).
`
`Byron, Dalby, et al., "CFC Propellant Substitution: P-i 134a as a Potential Replacement for
`
`P- 12 in MDI s," Pharmaceutical Technology, March 1990 (attached as Exhibit A).
`
`According to the article, one of the critical tests to be passed by any replacement
`
`propellant is its ability to dissolve the surfactants used in such formulations. Page 4, lines
`
`9-10. This test is repeated by Byron in the '029 patent at col. 3, lines 15-16. Given that
`
`Byron believed surfactant was a crucial component of an aerosol formulation, applicants'
`
`LAW OF
`
`ICEb
`
`I INNF) 'AN, HENDERSON,
`FARABOW, GARRETT1,
`8 D)UNNER,L.L.P.
`300 1 STREET, N. W.
`WASHINGTON, DC 20005
`202-405 4000
`
`9
`
`REPLACEMENT Mylan EX 1004, Page 9
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`

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`08/455,290
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`discovery, inter Ai,
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`that suitable aerosol formulations could be obtained without
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`surfactant confirms the non-obvious, patentable nature of applicants' invention.
`
`The above arguments concerning Byron also apply to the 35 U.S.C. § 103(a)
`
`rejection over Schultz, and the § 103(a) rejection over Byron in view of Schultz. Schultz
`
`discloses formulations containing propellant 134a or 227 or mixtures thereof,
`
`medicament, and surfactant with a lower concentration limit of 0. 00 1% by wei ght.
`
`Schultz prefers that the amount of surfactant used be approximately the minimum needed
`
`to provide a suitable suspension (pg. 5, lines 27-29). Contrary to the Examiner's
`
`argument, however, this in no way suggests the complete absence of surfactant. All
`
`working examples and claims in Schultz require the use of a surfactant, Indeed, the lower
`
`concentration limit of 0.001% disclosed in Schultz clearly suggests the importance of
`
`having surfactant present, albeit a very small amount. Schultz in no way suggests
`
`eliminating surfactant.
`
`In view of the express teachings of Schultz and Byron that surfactant be present,
`
`one of ordinary skill in the art would not suspect that suitable aerosol formulations could
`
`result from the complete exclusion of surfactant. Claims 105-115 are allowable over
`
`Byron and/or Schultz because Byron and Schultz disclose and uniformly teach the use of
`
`surfactant whereas applicants' claims positively exclude surfactant.
`
`INNEGAN, HENDER50N4,
`FARABOW, GARRETT
`8 DUNNFP,,L..Pr.
`1300 1 STREET, N. W.
`WA9H14NGT0N,0rC 20005
`202-408-4000
`
`10
`
`REPLACEMENT Mylan EX 1004, Page 10
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`

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`08/455,280
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`B.
`
`The Allowability of the New Claims Is Further
`Supported by the Substantial Overlap with the
`Claims of Interfering U.S. Patents
`
`Applicants' claims are directed to the same patentable invention claimed in the
`
`U.S. patents identified in Section 111, which patents were issued after consideration of the
`
`Byron and Schultz references relied upon by the Examiner in this case. For example,
`
`claim I of U.S. Patent No. 5,674,471 claims, in pertinent part,' a pharmaceutical aerosol
`
`formulation consisting essentially of (1) a particulate medicament which is salbutamol' or
`
`a physiologically acceptable salt or solvate thereof, (2) 1,1,1 ,2-tetrafluoroethane as
`
`propellant, and (3) less than 0.0001% surfactant based upon the weight oftmedicament.
`
`Applicants' claim 1 10 is substantially identical to allowed and patented claim 1 of the
`
`'471 patent and therefore is allowable for the same reasons.
`
`In addition, and by way of further example, claim 109 is directed to the same
`
`patentable invention as claim 1 of U.S. Patent No. 5,653,962 and claim 105 is directed to
`
`the same patentable invention as claim 1 of U.S. Patent Nos. 5,744,123 and 5,658,549.
`
`The currently pending claims and the claims of the patents listed below are all
`
`directed to the same patentable invention: surfactant-free pharmaceutical suspension
`
`-formulations suitable for aerosol administration that consist essentially of particulate drug
`
`I Claim 1 of the '471 patent also includes certain limitations to the weight of
`medicament, particle size of medicament, and proviso language, all of which are directed
`to subject matter that is substantially the same as or overlaps with pending claim 1 10.
`
`The terms "salbutamol" and "albuterol" refer to the same drug or medicament and
`2
`are used interchangeably.
`
`I11
`
`LAW orricEs
`HNNEG,AN, HENDER5ON,
`FAPABOT,§ GARRETT,
`& DUNNER,L.L.P.
`1300 1 STRE2FT, M. W.
`WASH1NC,T0N,100 20005
`202,408-4000
`
`REPLACEMENT Mylan EX 1004, Page 11
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`

`
`08/455,280
`
`and propellant 1,1,1 ,2-tetrafluoroethane. The United States patents described below have
`
`issued in view of the same references applied herein. Because the claims of the above
`
`patents all have been found to be patentable, it follows that at least those pending claims
`
`identified in -applicants' application which are directed to the same invention as the
`
`patented claims pmust be directed to patentable subject matter. For these additional
`
`reasons, applicants submit that the pending claims 105-122 are allowable.3
`
`111.
`
`Request For an Interference with Glaxo Patents
`
`An interference should be declared between claims 105-122 of this application
`
`and the claims of'seven patents, all assigned to Glaxo Group Limited. The seven patents
`
`are: U.S. Patent No. 5,674,471 ("the '471 patent") (Exhibit B);- U.S. Patent No.
`
`5,676,929 ("the '929 patent") (Exhibit C); U.S. Patent No. 5,658,549 ("the '549 patent")
`
`(Exhibit D); U.S. Patent No. 5,674,472 ("the '472 patent") (Exhibit E); UJ.S. Patent No.
`
`5,653,962 ("the '962 patent") (Exhibit F); U.S. Patent No. 5,683,676 (Exhibit G3); and
`
`U.S. Patent No. 5,744,123 ("the '123 patent") (Exhibit H) (collectively "the (Jlaxo
`
`patents").
`
`An interference is appropriate between an application and an unexpired patent of
`
`different parties when the application and patent contains claims directed to the same
`
`3 Applicants direct the Examiner to MPEP Section 2307.02, which requires the
`Group Director's signature to maintain a rejection of claims that is also applicable
`to patented claims.
`
`12
`
`LAW OFFICE-S
`I INl NEGAN, HFNDERSON,
`FARABOW, GARRETIT,
`8 D1JNNFR,L.L.P.
`1300 1 5TREfT, N, W.
`WA5H I NGTO N, DC 20 005
`202-408-4000
`
`REPLACEMENT Mylan EX 1004, Page 12
`
`

`
`patentable invention. 3 7 C.F.R. § 1.601 1(i). The test for ascertaining if claims are
`
`directed to the same patentable invention is set forth in 3 7 C.F.R. § 1.601 (n):
`
`08/455,280
`
`Invention "A" is the "same patentable invention" as an
`invention "B" when invention "A" is the same as (35
`U.S.C. Section 102) or is obvious (35 UJ.S.C, Section 103)
`in view of invention "B"3 assuming invention "B" is prior
`art with respect to invention "A."
`
`Under this test, the claims of the Glaxo patents are directed to the same patentable
`
`invention as claims 105-122 of the present application. Representative examples are
`
`illustrated below.
`
`A.
`
`U.S. Patent No. 5,674.471 and U.S. Patent No. 5.676,929
`
`Applicants' claims 1 10 and 115 (invention "A") are directed to the "same
`
`patentable invention" as claim 1 of the '471 patent and claim 1 of the '929 patent
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`(invention "B") because, assuming invention "B" is prior art against invention "A,"
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`invention "B" is the same as invention "A". In particular, invention "B" anticipates or
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`renders obvious invention "A" because claim 1 of the '471 patent overlaps with claim
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`1 10 and claim I of the '929 patent overlaps with claim 115.
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`Although the '471 patent is directed to a formulation and the '929 patent is
`
`directed to a canister containing the formulation, the claims are considered to be drawn to
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`the same patentable invention, i.e., a surfactant-free suspension aerosol formulation
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`consisting essentially of propellant 1 34a and albuterol. or a pharmaceutically acceptable
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`salt or soivate thereof.
`
`LAW OFFICES
`I~NEC.AM, HENDERSON,
`F ARABOW, GARRETT,
`6 D)IJNNER,L.1-1P-
`130O 1 STREET, N. W.
`WASHINGTON, DC 20005
`
`13
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`REPLACEMENT Mylan EX 1004, Page 13
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`08/455,280
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`B.
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`US, Patent No. 5,658,549 and U.S. Patent No. 5,674,472
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`Applicants' claims 105 and 115 (invention "A") are directed to the "same
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`patentable invention" as claim I of the '549 patent and claim I of the '472 patent
`
`(invention "B") because, assuming invention "B" is prior art against invention "A,"
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`invention "B" is the same as invention "A" within the meaning of 35 U.S.C. § 102. More
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`specifically, claim 1 of the '549 patent (which recites "fluticasone propionate or a
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`physiologically acceptable solvate thereof') anticipates applicants' claim 105 (Which
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`generically recites "drug").
`
`Again, although the '549 patent is directed to a formulation and the '472 patent is
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`directed to a canister containing the formulation, the claims are considered to be drawn to
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`the same patentable invention, i.e., a surfactant-free suspension aerosol formulation
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`consisting essentially of propellant 134a and fluticasone propionate or a pharmaceutically
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`acceptable salt or solvate thereof.
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`C.
`
`U.S PatetNo. 5653,962 and U.,S. Patent No. 5.683 .676
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`Applicants' claims 109 and 115 (invention "A") arc directed to the "same
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`patentable invention" as claim 1 of the '962 patent and claim 1 of the '676 patent
`
`(invention "B") because, assuming invention "B" is prior art against invention "A,"
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`invention "B" is the same as invention "A." More specifically, invention "B" anticipates
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`or renders obvious invention "A" because claim 109 overlaps with claim 1 of the '962
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`patent.
`
`FNNFG AN, I ENDERSON,
`F ARABow, GARRETT,
`F3 DUNNER,L.L.P.
`1300 1 STREET, N. W.
`WASHINI3TON, DC 20005
`202-408-4000
`
`14
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`As noted previously, although the '962 patent is directed to a formulation and the
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`'676 patent is directed to a canister containing the formulation, the claims are considered
`
`to be drawn to the same patentable invention, i.e., a surfactant-free suspension aerosol
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`formulation consisting essentially of propellant 134a and salmeterol or a
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`pharmaceutically acceptable salt or solvate thereof.
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`D.
`
`U.S. Patent No. 5.744,123
`
`Applicants' claims 108 and 112 (invention "A") are directed to the "same
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`patentable invention" as claim 1 of the '123 patent (invention "B") because, assuming
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`invention "B" is prior art against invention "A," invention "B" is the same as invention
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`"A" within the meaning of 35 U.S.C. § 103. More specifically, the selection of the
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`particular drugs of claims 108 and 112 would be obvious in view of their inclusion in
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`claim 1 of the '123 patent.
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`E.
`
`Proposed Count
`
`The proposed count encompasses applicants' broadest allowable pending claim,
`
`claim 105, and Glaxo's broadest patented claims. Applicants seek to provoke one
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`interference between the instant application and all of the above Glaxo patents. Because
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`applicants' broadest claims are generally broader than any individual Glaxo claim, the
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`proposed count is based on applicants' claim 105. Claim 105 is directed to a
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`pharmaceutical suspension aerosol formulation, consisting essentially of particulate drug
`
`and 1 34a, which is the same patentable invention as that recited in Glaxo's formulation
`
`claims, e.g., claim 1 of Glaxo's '962, '549, '471, and '123 patents, and Glaxo's canister
`
`HINNEGAN, I IENDERSON,
`F ARABOW, GARRETT,
`8 DINNRE,L.L.IK.
`
`1300 1 STREET, N. W.
`WASHINGTON 7 E0G 20005
`202-406-4000
`
`
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`REPLACEMENT Mylan EX 1004, Page 15
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`claims containing a suspension aerosol formulation suitable for delivery, e.g., claim 1 of
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`Glaxo's '472, '929, and '676 patents. However, certain of the Gilaxo claims specify, inte r
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`alia, that the formulation contains less than 0.000 1 % w/w surfactant, which is only
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`minimally hioader than applicants' claim limitation of "no surfactant." Thus, applicants
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`propose that the count be drafted in the alternative as indicated below:
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`PROPOSED COUNT
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`A pharmaceutical suspension aerosol formulation consisting
`essentially of,
`
`(i)
`
`(ii)
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`particulate drug; and
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`1,1,1 ,2-tetrafluoroethane as propellant, wherein the
`formulation is further characterized in that it
`contains no surfactant or less than 0.0001% w/w
`surfactant based upon the weight of the drug,
`
`with the proviso that when said formulation consists of albuterol.
`and 1, 1, 1,2-tetrafluoroethane in a weight ratio of 0.05:18 said albuterol is
`present in the form of a physiologically acceptable salt, and that when said
`formulation consists of albuterol. or physiologically acceptable salts or
`solvates thereof, the weight of the drug to drug plus propellant is other
`than 0.866%.
`
`Applicants acknowledge that the claims of the '472, '929, and '676 patents are
`
`directed to canisters containing the recited pharmaceutical aerosol suspension
`
`formulations. Nonetheless, it is applicants' belief that the above count and the claims of
`
`the '472, '929, and '676 patents are directed to the same patentable invention under 3 7
`
`C.F.R, § 1.601(n). In other words, a canister containing a metering valve to administer
`
`[ INNEGAN, HENDERSON,
`I ARAEBOW, GARRET F,
`8 DUNNER, L.L. P.
`300£1 STREET, N. W.
`WAS HI NGON7DC 20005
`202,408 -4000
`
`16
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`pharmaceutical suspension aerosol formulations would have been obvious to one skilled
`
`in the art under 35 U.S.C. § 103 in view of the pharmnaceutical suspension aerosol
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`formulation assuming it were prior art.
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`Applicants' proposed count satisfies the requirement of 37 C.F.R. § 1.606 that at
`
`the time of declaring an interference, a count shall not be narrower in scope than any
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`application claim that is patentable over the prior art and designated to correspond to the
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`count or any patent claim that corresponds to the count.
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`F.
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`Claims Corresponding to the Proposed Count
`
`All claims in the involved application and patents are directed to the same
`
`patentable subject matter and therefore should be designated to correspond to the count.
`
`A claim corresponds to a count if, considering the count as prior art, the claim would be
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`unpatentable over the count under 35 U.S.C. §§ 102 or 103. MPEP 2309.02. Further, a
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`claim either corresponds exactly to the count or corresponds substantially to the count.
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`37 C.F.R. §'1.601(f).
`
`(1)
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`Applicants' Claims Corresponding to Proposed Count
`
`Applicants' claims 105-122 should be designated as corresponding to the count.
`
`Pending claims 105-122 all correspond substantially to the count. Claim 105 corresponds
`
`substantially to the count and, assuming the count was prior art, would be the same
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`invention as the count within the meaning of 35 U.S.C. §§ 102, 103. Claims 106-122
`
`correspond substantially to the count and, assuming the count was prior art, would have
`
`been obvious in view of the count. For example, the specific recitation of "albuterol" in
`
`17
`
`LAW OFFICES
`F INNEGAN, HENDER50N,
`FARABOW, GARRET-r,
`85 DUNNER,L.L.P.
`1,00 T STREET, N. W.
`WASHINGTON, 00 20005
`202 -4086 4000
`
`REPLACEMENT Mylan EX 1004, Page 17
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`claim 1 10, assuming the count is prior art, would have been obvious to the skilled artisan
`
`in view of the term "drug" in the count and the status of albuterol as a well known
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`medicament for the treatment of respiratory disorders. Further, the aerosol canister
`
`recited in claim 115, assuming the count was prior art, also would have been obvious to
`
`the skilled artisan because claim 115 recites a canister having a metering valve and
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`containing a pharmaceutical suspension aerosol formnulation substantially identical to that
`
`recited in the count.
`
`(2)
`
`Glaxo's Claims CorrespondLto the Proposed Count
`
`In general, the claims of each Gilaxo patent are directed to a pharmaceutical
`
`aerosol formulation4 consisting essentially of.
`
`(i)
`
`particulate drug or a physiologically acceptable salt or solvate thereof,
`
`(ii)
`
`1, 1, 1,2-tetrafluoroethane as a propellant; and
`
`(iii)
`
`less than 0.0001% w/w surfactant based upon the weight of the
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`medicament.
`
`(i)
`
`Claims 1-3 9 of U. S. Patent No. 5,65 3,962 and claims 1-3 2
`
`of U.S. Patent No. 5,683,676 correspond substantially to the proposed count. For
`
`example, claims 1-39 of the '962 patent, assuming the count is prior art, would have been
`
`4 Glaxo's claims also cover a canister suitable for delivering a pharmaceutical
`aerosol formulation (see, e,g., claim 1 of the 472 patent) and a method for using a
`pharmaceutical aerosol formulation to treat respiratory disorders (see. e.g, claim 22 of
`the '962 patent). Applicants nonetheless believe that the proposed count encompasses
`these obvious variants and requests that all Glaxo claims, including those directed to
`canister or a method of use be designated as substantially corresponding to the count.
`
`18
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`LAW OFFICES
`
`IUMAN^ HENDERSON,
`FAR&ABOW, GARRETT
`A DIJNNE,L.L.P.
`1300 I. STREET, N. W.
`NVASHINOTON 1 0D 20005
`202-405-4000
`
`
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`REPLACEMENT Mylan EX 1004, Page 18
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`obvious to one skilled in the art in view of the count. Specifically, claim I of the '962
`
`patent is nearly identical to the count except that claim 1 recites, inter alia, "salmeterol or
`
`a physiologically acceptable salt or solvate" in place of the term "drug" as recited in the
`
`count. The specific selection of salmeterol, assuming the count is prior art, would have
`
`been obvious to one skilled in the art in view of the recitation of "drug" in the count.
`
`This is particularly true in view of the broad disclosure of "drugs," including salmeterol,
`
`in applicants' specification and the status of salmeterol as a well-known medicament for
`
`the treatment of respiratory disorders.
`
`Claims 1-32 of the '676 patent are directed to a canister containing the
`
`formulation of the '962 patent. Assuming the count is prior art, these claims wou