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`UNITED STATES DEPARTMENT OF COMMERCE
`
`United States Patent and Trademark Office
`
`March 3!]. 10115
`
`THIS IS TO CERTIFY THAT ANNEXED HERETO IS A TRUE COPY FROM
`
`ISSUE DATE: August 04, 2015
`
`THE RECORDS OF THIS OFFICE OF:
`
`
`
` U.S. PATENT: 9,095,559
`
`
`
`
`
`
`MM A flaw/um
`
`
`
`By Authority of the
`
`Under Secretary of Commerce for Intellectual Property'
`_
`ii“.-
`
`.
`and Director of the United States Patent and Trademark Office
`«I.
`
`
`
`
`
`
`
`
`ANDREA T BENNETT
`
`Certifying Officer
`
`
`
`Par Pharmaceutical, Inc. Ex. 1001
`Par v. Horizon, IPR of Patent No. 9,095,559
`Page 1 of 23
`
`

`

`llllfllllllllllIIIIIIIIIIIIIIIII
`U8009095559B2
`
`(12) United States Patent
`(10) Patent N0.:
`US 9,095,559 B2
`Scharschrnldt et a1.
`(45) Date of Patent:
`Aug. 4, 2015
`
`(54) METHODS or THERAPEUTIC
`MONITORING OF NITROGEN SCAVENGING
`DRUGS
`
`(71) Applicam: Horizon Therapeutics, 1110., Palo Alto,
`CA (03}
`
`(58] Field ol Classification Search
`CPC ......,.._.. AGJK 31!2l6; GO]N31!221; YIOT
`436/175383
`42419.2; 5141432, 433, 544, 570, 533;
`43614. 113
`See npplicafionfile for cunpleie smell history
`
`USPC
`
`(12) mm:
`
`Bruce Schumhmldt, San Francisco,
`CA (US); M80110 Mokhurani, Walnut
`Cheek, CA (US)
`
`(56)
`
`(73) Mame:
`
`110mm mmmcs, INC,
`Deerfield, 1mm)
`
`( ' ) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is exuded or adjusted under 35
`use. 1540:) by 230011313.
`
`(21)
`
`(22)
`
`(55)
`
`(62)
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`(60)
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`(51)
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`(52)
`
`App]. No.2 13m5,000
`Filed:
`
`Feb. :2, 2013
`
`P1101- Pnblieaflon Data
`
`US 201 303210914181
`
`Aug. 15, 2013
`
`Related US. Application Data
`Division ofapplication No. 13i417,137, filed on Mar.
`9, 2012, new Pat. No. 8,404,215.
`
`Provisional applicaiion No. 611542.100, filed on Sep.
`30, 2011, provisional application No. 61/564,668,
`filed onNov. 29, 2011.
`
`Int. CL
`A61K 49/00
`:1le 1m
`A61K31/216
`GMN 31/22
`[1.8. CI.
`CPC
`
`(2005.01)
`(2005.01)
`(2005.01)
`(2005.01)
`
`AGK3M16 (2013.01); GOINJIB)!
`(2013.01); Y10T436/I 75333 (2015.01)
`
`References Cited
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`SH”! Bmsilolw eta].
`71'1984 Blulllflw
`$1997 Samid
`1010999 Brunilow
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`4.234.647 A
`4.457.942 A
`5.554533 A
`5,963,979 A
`5.050.510 A
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`(Continued)
`
`FOREIGN PATENT DOCUMENTS
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`W0 20135106360“:r Al
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`omen PUBLJCM‘IONS
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`3mm ML. et 01.01.13. 1981) ‘NewAppmachem the Diagnosis
`uni Treahnem of [inborn Errors of Urea Symmesisr Podium:
`“(2)3904”.
`
`(Cominued)
`
`Primary Emmioer — Savitha Rao
`
`ABSTRACT
`(57)
`“represent disclosure provides mefliods for evaluating daily
`ammonia mpomne based on a single timing ammonia blood
`level moment, as well as methods that utilize this tech-
`nique to adjust 1112 dosage of a nitrogen scavenging drug,
`determine whethaio adminisla‘a nitrogen. scavenging drug.
`and treat nilmg retenfion disorders.
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`Copy provided by USPTO from lhe PIRS Image Database on 0012112016
`Par Pharmaceutical, Inc. Ex. 1001
`Par v. Horizon, IPR of Patent No. 9,095,559
`Page 2 of 23
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`US 9,095,559 Bl
`Page 2
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`(56)
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`W0 W0 20061056794
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`Copy provided by USPTO Item the PIHS Image Database on 03:21:20”
`
`Par Pharmaceutical, Inc. Ex. 1001
`Par v. Horizon, IPR of Patent No. 9,095,559
`Page 4 of 23
`
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`US 9,095,559 32
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`Page 4
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