`Approved for use through 10/31/2002. OMB 0651-0031
`US. Patent and Trademark Office: US. DEPARTMENT OF COMMERCE
`Under the Paerwork Reduction Act of 1995, no ersons are reuired to resond to a collection of information unless it disla s a valid OMB control number.
`Subs‘itute f°r f°rm 1449””
`
`INFORMATION DISCLOSURE
`STATEMENT BYAPPLICANT
`(“59 as many sheets as necessary)
`Sheet 1 of 1
`
`-——
`G Am“
`“527
`
`Examiner Name
`Claytor, Deirdre
`Attorney Docket Number
`PRD2901USNP
`
`OTHER PRIOR ART - NON PATENT LITERATURE DOCUMENTS
`
`Include name of the author (in CAPITAL LETTERS) title of the article (when appropriate) title of the item
`
`
`
`Cleton A, Rossenu S, Crauwels H, et al. A single-dose, open-label, parallel,
`randomized, dose-proportionality study of paliperidone after intramuscular injections
`of paliperidone palmitate in the deltoid or gluteal muscle in patients with
`
`schizophrenia. J Clin Pharmacol. 2014;54(9):1048-1057
`Cleton A, Rossenu S, Hough D, Crauwels H, Vandebosch A, Berwaerts J, Eerdekens
`M, Francetic, I. "Evaluation of the pharmacokinetic profile of gluteal versus deltoid
`intramuscular Injections of paliperidone palmitate 100 mg equivalent in patients with
`schizophrenia" Clin.Pharmaca/. Therapeutics. Published March 2008
`Cockshott WP, Thompson GT, Howlett LJ, Seeley ET. Intramuscular or
`intralipomatous in'ections? N EnlJ Med. 1982;307 6 :356-358
`Haramati N, Lorans R, Lutwin M, Kaleya RN. Injection granulomas. Intramuscle or
`intrafat? Arch Fam Med. 1994;3 2 :146-148
`Janicak, P. G. and Winans, E. A. "Paliperidone ER: a review of the clinical trial data"
`Neurops chiatr. Dis. Treat. 2007, Dec 3 6 : 869 - 897
`Rosen, H, and Abribat, T. "The rise and rise of drug delivery" Nat. Rev. Drug Discov.
`2005, Ma 4 5 : 381-5.
`Rossenu S, Cleton A, Hough D, et al. Pharmacokinetic profile after multiple deltoid or
`gluteal intramuscular injections of paliperidone palmitate in patients with
`schizophrenia. Clinical Pharmacolo '
`Development. 2015;4 4 :270-278
`Samtani MN, Vermeulen A, Stuyckens K. Population pharmacokinetics of
`intramuscular paliperidone palmitate in patients with schizophrenia: a novel once-
`monthly, long-acting formulation of an atypical antipsychotic. Clin Pharmacokinet.
`2009;48(9):585-600
`Synopsis of the Phase III clinical study described at Example 8 of the opposed
`application accessed at http://yoda.yale.edu/sites/defauIt/files/nct00590577.pdf on 17
`Au. ust 2015
`
`Examiners
`Initials*
`
`Cite
`No.
`
`(book magazine journal serial symposium catalog etc.) date page(s) volume-issue number(s)
`”ublisher cit and/orcountr where oublished
`
`-I_J&J File Ref. PRD2901AUPCT
`-I—Opposition for AU Patent Appl No. 2008340101 J&J File Ref. PRD2901AUPCT
`
`Yin J, Collier AC, Barr AM, Honer WG, Procyshyn RM. Paliperidone Palmitate Long-
`Acting Injectable Given Intramuscularly in the Deltoid Versus the Gluteal Muscle: Are
`They Therapeutically Equivalent? J Clin Psychopharmacol. 2015;35(4):447-449
`
`Examiner
`Sionature
`
`
`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through citation if not in conformance
`and not considered. Include copy of this form with next communication to applicant.
`
`Date
`Considered
`
`Mylan V. Janssen (IPR2020-00440) EX. 1026 p. 001
`
`Mylan v. Janssen (IPR2020-00440) Ex. 1026 p. 001
`
`
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