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`
`US008313776B2
`
`(12)
`
`United States Patent
`Burnside et al.
`
`(10) Patent No.:
`(45; Date of Patent:
`
`US 8,313,776 B2
`*Nov. 20, 2012
`
`4.680.386 A
`4.710.565 A
`4.723.958 A
`4.728.512 A
`4.749.568 A
`4.755.385 A
`4.775.751 A
`4.794.001 A
`4.808,411 A
`4.812.561 A
`4.828.836 A
`4.831.025 A
`4.835.140 A
`4.842.866 A
`4.849.515 A
`4.879.135 A
`4.894.119 A
`4.895.934 A
`4.904.476 A
`4.915.953 A
`4.945.080 A
`4.945.405 A
`4.971.805 A
`4.990.602 A
`5.011.692 A
`5.045.533 A
`5.051.262 A
`
`(54)
`
`ANTIBIOTIC PR()l)UCT, USE AND
`FORMULATION THEREOF
`
`(75)
`
`Inventors; Beth A. Burnside. Bethesda. Ml) (US):
`llenry ll. Flanner, Montgomery
`Village. MD (US): Colin Rowllngs.
`Potomac. MD (US)
`
`(73)
`
`Assignee: Shionogi Inc.. Florbam Park. NJ (US)
`
`(*)
`
`Notice:
`
`Subject to any disclaimer. tl1e term of this
`patent is extended or adjusted under 35
`U.S.C. 154{b)by 1096 days.
`
`This patent is subject to a terminal dis-
`claimer.
`
`(21)
`
`Appl. No.: 101894.994
`
`(22)
`
`Filed:
`
`Jul. 20. 2004
`
`(65)
`
`Prior Publication Data
`
`US 200570019403 Al
`
`Jan. 27. 2005
`
`Related U.S. Application Data
`
`(69)
`
`Provisional application No. 601488.901. Filed on Jul.
`21. 2003.
`
`CA
`
`(51)
`
`(52)
`
`(53)
`
`(55)
`
`Int. Cl.
`(2006.01)
`.46IK 9.416
`U.S. (I1.
`...... ,. 4247490: 4241457; 4247458: 4241468;
`4247469
`None
`
`.
`Field efClassification Search
`See application file for complete searcliliistory.
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`1"()Rl:7.l(iN l-’A'1'l£N'1‘ l)()(‘1JMl_iN'l'S
`2533358 Al
`2-"2005
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`(Continued)
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`OTHER PUBLICATIONS
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`l1Ltp:.-'.-’2mer-
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`.\«'1edlinePlns. Merriar11—Webster. definition "eliniczll". 11ttp:.'.u"21ner—
`riam-wcbster.comr'cgi-bin*'mw:n(x1nln1.*
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`Pr.f».=m'_r Exaniirier — Betltaity l3arl1:tm
`(74) Attorney. Agent. or Firm — M1-12 Teclmology Law
`Group [LP
`
`(57)
`
`ABS'l'RAC'l'
`
`An antibiotic product is comprised of at least three dosages
`forms. each of which has a di1Terent release prolilc. with the
`Cm, for the antibiotic product being reached in less than
`about twelve hours. In one embodiment. there is an immedi-
`
`ate release dosage fonn. a delayed release dosage form. and a
`sustained release dosage form. with each of the dosage tiomis
`having a different release profile, wherein each reaches a
`‘man
`C
`at different times.
`
`16 Claims, No Drawings
`
`Amerigen Ex. 1031, p. 1
`Amerigen Ex. 1031, p. 1
`
`.
`
`..
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`-.V1ori1noloet'al.
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`2.11988 Popcctal.
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`10.-‘I988 N1cS111Lne
`12.-‘"1988 Mehtaet a].
`231989 1.1: et al.
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`371.989 Hamashimaet :11.
`531989 Elgerel al.
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`5-‘I989 Smith et a1.
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`6.31989
`llordcr ctal.
`7.-‘I989 Nlatieretal.
`ll.-‘I989 Grecoetal.
`1.-'1990 Baron. Jr. et al.
`111990 Matieretal.
`2.-‘I990 Mehtaet a].
`4-"1900 Jordan etal.
`7.-"1990 Lindstrom eta].
`771990
`llirota ........... ..
`1171990 Kitanislii ct .11.
`..
`231991 Nlorimoto et .1].
`4.-‘"1991 Fujioka et a1.
`.... ..
`9.-"1991 Philippcetal.
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`9-‘I991 Panozetal.
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`53657.4
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`424-"468
`
`
`
`. .
`
`
`
`

`
`US 8,313,776 B2
`Page 2
`
`u,s,pATENT DOCUMENTS
`
`53577.2
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`Amerigen Ex. 1031, p. 2
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`US 8,313,776 B2
`Page 3
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`

`
`US 8,313,776 B2
`Page 4
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