(12)
`
`United States Patent
`Scharschmidtet al.
`
`(10) Patent No.:
`(45) Date of Patent:
`
`US 9,095,559 B2
`Aug. 4, 2015
`
`US009095559B2
`
`METHODS OF THERAPEUTIC
`MONITORING OF NITROGEN SCAVENGING
`DRUGS
`
`(58)
`
`(54)
`
`(71)
`
`(72)
`
`Applicant: Horizon Therapeutics, Inc., Palo Alto,
`CA (US)
`
`Inventors:
`
`Bruce Scharschmidt, San Francisco,
`CA (US); Masoud Mokhtarani, Walnut
`Creek, CA (US)
`
`(73)
`
`Assignee:
`
`HORIZON THERAPEUTICS,INC.,
`Deerfield, IL (US)
`
`Notice:
`
`Subject to anydisclaimer, the term of this
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 230 days.
`
`(21)
`
`Appl. No.: 13/775,000
`
`(22)
`
`Filed:
`
`Feb. 22, 2013
`
`Field of Classification Search
`CPC vee AG6IK 31/216; GOIN 31/221; Y1OT
`436/175383
`USPC wees 424/9.2; 514/432, 433, 544, 570, 533;
`436/4, 113
`See applicationfile for complete search history.
`
`56)
`
`References Cited
`
`U.S. PATENT DOCUMENTS
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`4,284,647 A
`4,457,942 A
`5,654,333 A
`5,968,979 A
`6,050,510 A
`
`8/1981 Brusilowetal.
`7/1984 Brusilow
`8/1997 Samid
`10/1999 Brusilow
`4/2000 Bonnewitz
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`(Continued)
`
`FOREIGN PATENT DOCUMENTS
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`WO
`Wo
`
`WO94/22494
`WO 2005/053607 Al
`
`10/1994
`6/2005
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`(Continued)
`OTHER PUBLICATIONS
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`Batshaw, M.L. et al. (Aug. 1981) “New Approachesto the Diagnosis
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`68(2):290-297.
`
`(Continued)
`
`Primary Examiner — Savitha Rao
`
`Prior Publication Data
`
`US 2013/0210914 Al
`
`Aug. 15, 2013
`
`Related U.S. Application Data
`
`Divisionofapplication No. 13/417,137,filed on Mar.
`9, 2012, now Pat. No. 8,404,215.
`
`Provisional application No. 61/542,100,filed on Sep.
`30, 2011, provisional application No. 61/564,668,
`filed on Nov. 29, 2011.
`
`(65)
`
`(62)
`
`(60)
`
`(52)
`
`ABSTRACT
`(57)
`Int. Cl.
`(51)
`The present disclosure provides methodsfor evaluating daily
`AGIK 49/00
`(2006.01)
`ammonia exposure based onasingle fasting ammonia blood
`AGIP 13/00
`level measurement, as well as methodsthat utilize this tech-
`(2006.01)
`AG6IK 31/216
`(2006.01)
`nique to adjust the dosage of a nitrogen scavenging drug,
`GOIN 31/22
`(2006.01)
`determine whether to administer a nitrogen scavenging drug,
`U.S. Cl.
`and treat nitrogenretention disorders.
`CPC veces AGIK 31/216 (2013.01); GOIN 31/221
`(2013.01); Y/OT 436/175383 (2015.01)
`
`15 Claims, 3 Drawing Sheets
`
`Page 1 of 22
`
`Horizon Exhibit 2005
`Horizon Exhibit 2005
`Lupin v. Horizon
`Lupin v. Horizon
`IPR2017-01159
`IPR2017-01159
`
`Page 1 of 22
`
`

`

`US 9,095,559 B2
`Page 2
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