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`U80092542?SBZ
`
`(12) United States Patent
`Scharschmidt et :1].
`
`[10) Patent No.:
`(45) Date of Patent:
`
`US 9,254,278 B2
`*Feb. 9, 2016
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`(54)
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`(71}
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`(72)
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`(73)
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`METHODS OF THERAPEUTIC
`MONITORING OF NITROGEN SCAVENGING
`DRUGS
`
`Applicant: Horizon Therapeutics, Inc.. Deerlield.
`II. (US)
`
`Inventors: Bruce Scharschmidt. San Francisco.
`CA (US): Masoud Moklltarani. Walnut
`Creek. (‘A (US)
`
`Assignees Horizon Therapeutics, Inc.. Deerfield.
`11., (US)
`
`(*1
`
`Notice:
`
`Subject to any disclaimer. the term oi‘this
`patent is extended or adjusted under 35
`U.S.C. 15403) by 0 days.
`
`This patent is subject to a terminal dis-
`claimer.
`
`(21)
`
`Appl. No.: magician
`
`(22)
`
`l’iled:
`
`Aug. 3, 2015
`
`(65)
`
`(63)
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`(60)
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`(so
`
`Prior Publication Data
`
`US 20150335605 Al
`
`Nov. 26. 2015
`
`Related US. Application Data
`
`Continuation of application No. 131775.000, filed on
`Feb. 22. 2013. now Pat. No. 9.095.559. which is a
`continuation of application No. l3f4l7.137. filed on
`Mar. 9. 2012. now Pat. No. 8.404.215.
`
`Provisional application No. GUS-12.100. filed on Sep.
`30. 2011. provisional application No. 613564.668.
`filed on Nov. 2.9. 2011.
`
`Int. Cl.
`A6IK 49/00
`A6IP 13/00
`
`(2006.01)
`(2006.01 )
`(Continued)
`
`(52}
`
`US. Cl.
`CPC
`
`33/4925 (2013.01): GUIN 2800/08.? (2013.01):
`Y10T436/1‘ 75383 (2015.01)
`(58) Field of Classification Search
`CPC
`AfilK 31l216: GOIN 31f221: Y10'I
`4361'1715383
`USPC ......... .. 42419.2: 514E432. 433. 544. 570. 533‘
`436%. 1 1?;
`See application file for complete search history.
`
`[56)
`
`References Cited
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`U .S. PATENT DOCUMENTS
`
`4.284.647 A
`4.452.942 A
`
`851981 Bnisilowetal.
`11984 Brusilow
`
`(Continued)
`
`FOREIGN PATENT DOCUMENTS
`
`Wt)
`W0
`
`Wt2)94.-"22494
`W02003-“05360?
`
`|0-' | 994
`6-2005
`
`{Continued}
`
`OTHER PUBLICATIONS
`
`Amodie. R. at 3].. “Detection of Minimal Hepatic Encephalopathy:
`Normalization and Optimization of the Psychometric Hepatic
`Encephalopathy Score. A Neuropsychological and Quantified EEG
`Study.” J. l'lepatol. 49346-3 53 {2008).
`(Continued)
`
`Primal?! lz‘xaminer
`
`Savitha Rao
`
`(5?)
`
`ABSTRACT
`
`The present disclosure provides methods for evaluating daily
`anunonia exposure based on a single fasting. ammonia blood
`level measurement. as well as methods that utilize Iliis tech-
`nique to adjust the dosage of a nitrogen scavenging drug.
`determine whether to administer a nitrogen scavenging drug.
`and treat nitrogen retention disorders.
`
`A61K3I/21’6 (2013.01): A61K 9/0053
`(2013.01 )1_ (MIN 31/221 (2013.01): COIN
`
`15 Claims, 3 Drawing Sheets
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`1 of 22
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`1 of 22
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`US 9,254,278 BZ
`Page 2
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`Int. Cl.
`A6IK 31/216
`A6IK 9.490
`COIN 31/22
`(ram 33/49
`
`[2006.01]
`(2006.01)
`(2006.01)
`(2006.01 )
`
`(56)
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`References Cited
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`U.S. PATENT DOCUMENTS
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`8.642.012 B2
`9.078.865 I32
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`4:“2015 Scharsclnnidtetal.
`4:20 15 Scharschmidt et a1.
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`FOREIGN PATENT DOCUMENTS
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