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`United States Patent and Trademark Office
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`UNITED STATES DEPARTMENT OF COMMERCE
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`May 09.2015
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`THIS IS TO CERTIFY THAT ANNEXED HERETO 1s A TRUE COPY FROM
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`U.S. PATENT: 9,326,966
`
`ISSUEDATE: May03,2016
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`r
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`By Authority of the
`
`I:.
`I.
`Under Secretary of Commerce for In ellectuul Pmperty
`and Director of the United States
`I and Trademark Office it”.
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`1". SWAIN
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`Certifying
`l'ficer
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`
`
`
`
`Par Pharmaceutical, Inc. Ex. 1001
`Par v. Horizon, IPR of Patent No. 9,326,966
`Page 1 of 23
`
`

`

`(12) United States Patent
`Scharschmidt et al.
`
`.. US 9,326,966 BZ
`(10) Patent No.:
`(45) Date of Patent:
`*May 3, 2010
`
`USOO9326966B2
`
`(54)
`
`(71)
`
`(72)
`
`(73)
`
`METHODS OF THERAPEUTIC
`MONI'IDRIING 0F NITROGEN SCAVENGING
`DRUGS
`
`Applicant: Hal-hen Thy-panties, 1110., Deerfield,
`IL (US)
`
`Ionian: Bruno Schuochmidl, San ancisco,
`CA (us); Mlloml Mokhtoranl, Walnut
`Creek, CA (US)
`
`Avignon: Horizon Therapeutics, Ina, Lake
`Forest, IL (US)
`
`U“)
`
`Notice:
`
`Subject 00 any disclaimer, the term ofthis
`patent is extended or adjusied under 35
`USC. 1540:) by 0 days.
`This patent is abject to a terminal dis-
`claim.
`
`(21)
`
`Appl. 110.: 141958359
`
`(22)
`
`Filed:
`
`Dec. 3. 2015
`
`(65)
`
`(63)
`
`(m)
`
`(51)
`
`Prior Puhlloatlon Data
`
`US 201M1081969 Al
`
`Mm: 24. 2016
`
`Behind “.8. Application Data
`(bmimfion of application No. 1031:3674, filed on
`Aug. 3, 2015, now Pat. No. 9,254,278, which is a
`continuation ofapplicetion No. 131175000. filed on
`Feb. 22. 2013, now Pat. No. 9,095,559. which is a
`continuation of application No. 131417.137, filed 011
`Mar. 9, 2012, now Pat. No. 8,404,215.
`
`Provisional application No. 611542.10), filed on Sep.
`30; 2011, provisional application No. $564,668,
`filed on NOV. 29. 2011.
`
`[11001.
`AGIKW
`A61? 13/00
`
`(2006.01)
`(2005.01)
`
`A61E31/235
`name
`
`(2006.01)
`(0005.01)
`
`(52) U.s.c1.
`cpc
`
`Aaxsms(2013.01);.461xmm
`(2013.01)
`
`(58) Field of Classification Search
`CPC .. .......... A61K31f216; GOlN 31(22]; YIOT
`4313075383
`See application file for complain search history.
`
`(56)
`
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`
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`711984 Bum
`
`(Continued)
`FOREIGN mam DOCUMENTS
`
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`(Continued)
`omen PUBLJCAZI'IONS
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`levelmeasurunengaswellaamethodsthatmiliufliistech—
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`detaminewheihumadministuaniuogenmmgingdmg,
`andtreanitmgenxetmfiondimtdm.
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`Copy provided by USPTO from “10 P‘BS Image Daiabau on 0510512016
`
`Par Pharmaceutical, Inc. Ex. 1001
`Par v. Horizon, IPR of Patent No. 9,326,966
`Page 2 of 23
`
`

`

`US 9,326,966 32
`Page:
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`1110
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`11.102110910117474
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`01020131150145
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`1012013
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`
`Par Pharmaceutical, Inc. Ex. 1001
`Par v. Horizon, IPR of Patent No. 9,326,966
`Page 4 of 23
`
`

`

`US 9,326,966 B2
`Page 4
`
`(56]
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