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`IN FORMATION DISCLOSU RE
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`STATEMENT BY APPLICANT
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`FOREIGN PATENT DOCUMENTS -
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`Examiner Cite Foreign Document
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`Number3
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`, 011,045.”?
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`011/057350
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`'011/143008
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`EFS Web 2.1.17
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`Kind
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`ApplIcant Of c'ted
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`nIverSIta DelgI StudI DI
`errara
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`he UnIverSIty of Western
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`he Charlotte—
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`ecklenburg Hospital
`- uthority DIB/A
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`STATEMENT BY APPLICANT
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`( Not for submission under 37 CFR 1.99)
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`Art Unit
`| MIA
`Examiner Name
`Not Yet Assigned
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` Attorney Docket Number
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`IN FORMATION DISCLOSU RE
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`First Named Inventor
`Peter SAZANI
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`Application Number
`15789862
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`Filing Date
`2017-10-20
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`2012—01—05
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`2012—11—08
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`- vi Biopharma, Inc
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`2013—03—07
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`2014—01—09
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`arepta Therapeutics, Inc
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`IN FORMATION DISCLOSU RE
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`First Named Inventor
`Peter SAZANI
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`Application Number
`15789862
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`Filing Date
`2017-10-20
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`STATEMENT BY APPLICANT
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`( Not for submission under 37 CFR 1.99)
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`Art Unit
`| MIA
`Examiner Name
`Not Yet Assigned
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` Attorney Docket Number
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`Ui
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`2014—06—26
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`arepta Therapeutics, Inc
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`2014—09—25
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`2014—10—23
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`arepta Therapeutics, Inc
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`arepta Therapeutics, Inc
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`es Inst At Nationwide
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`hildren S Hospital
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`HERAPEUTICS, INC.
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`201 7—04—06
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`arepta Therapeutics, Inc
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`1993—10—14
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`- bbott Laboratories
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`Application Number 15789862
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`Filing Date
`2017-10-20
`First Named Inventor
`Peter SAZANI
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`Art U .
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`mt
`I N/A
`Examiner Name
`Not Yet Assigned
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`I AVN-OOQDVCNT
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` Attorney Docket Number
`1997—09—25
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`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
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`( Not for submissmn under 37 CFR 1.99)
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`.7/30067 . A1
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`1997—08—21
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`-7-’34533
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`A1
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`he Regents of the
`niversity of California
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`If you wish to add additional Foreign Patent Document citation information please click the Add button
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`NON-PATENT LITERATURE DOCUMENTS
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`Examiner Cite
`|nitia|s*
`No
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`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
`(book, magazine, journal, serial, symposium, catalog, etc), date, pages(s), volume-issue number(s),
`publisher, city and/or country where published.
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`T5
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`laims from US Application No. 11/233,495, 6 pages, dated September 21, 2005 (Exhibit Number 2068 filed in
`nterferences 106008, 106013, 106007 on November 18, 2014)
`
`lassification Excerpts from USPC System, 21 pages, (Academisch Ziekenhuis Leiden Exhibit 1234, filed May 5, 2015
`n Interference 106007 and 106008).
`
`OLLINS, C_A_ et al_, "Duchenne's muscular dystrophy: animal models used to investigate pathogenesis and develop
`herapeutic strategies," Int. J. Exp. Pathol., Vol. 84(4):165—172 (2003)
`
`onfirrnation of Dystrophin Exon 48 to 50 Deletion in Cell Line 8036 Laboratory Notebook Entry, Pages 3, Exhibit
`umber 1167 filed in Interferences 106,007 and 106,008 on February 16, 2015.
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`5
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`onfirrnation of Dystrophin Exon 52 Deletion in Cell Line R1809 Laboratory; Notebook Entry, Pages 3, Exhibit
`umber 1168 filed in Interferences 106,007 and 106,008 on February 16, 2015.
`
`onfirrnatory Study of Eteplirsen in DMD Patients, An Open—Label, Multi—Center, 48—Week Study With a Concurrent
`ntreated Control Arm to Evaluate the Efficacy and Safety of Eteplirsen in Duchenne Muscular Dystrophy ,Clinical
`rials.gov, Clinical Trial Identifier NCT02255552, October 1, 2014, 3 pages
`
`onfirrnatory Study of Eteplirsen in DMD Patients, An Open—Label, Multi—Center, 48—Week Study With a Concurrent
`ntreated Control Arm to Evaluate the Efficacy and Safety of Eteplirsen in Duchenne Muscular Dystrophy, Clinical
`rials.gov, Clinical Trial Identifier NCT02255552, May 26,2015, 3 pages.
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`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
`.
`.
`( Not for submissmn under 37 CFR 1.99)
`
`Application Number 15789862
`
`Filing Date
`2017-10-20
`First Named Inventor
`Peter SAZANI
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`Art U .
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`mt
`I N/A
`Examiner Name
`Not Yet Assigned
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` Attorney Docket Number
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`oolidge v. Efendic, 2008 WL 2080735, Int. No. 105,457 (BPAI May 16, 2008), 42 pages, (Academisch Ziekenhuis
`eiden Exhibit 1235, filed May 5, 2015 in Interference 106007 and 106008).
`
`OREY, David R. et al., "Morpholino antisense oligonucleotides: tools for investigating vertebrate development,‘
`enome Biology, Vol. 2(5):1015.1 - 1015.3 (2001) (Exhibit Number 1026 filed in interferences 106008, 106007 on
`ovember 18, 2014)
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`orrected Priority Statement filed by UWA in Int. No. 106,008 (as PN 219),Pages 5, Exhibit Number 1002 filed in
`nterference 106,013 on February 17, 2015.
`
`ortes, Jesus J., et al., "Mutations in the conserved loop of human U5 snRNA generate use of novel cryptic 5‘ splice
`ites in vivo," EMBO J., Vol. 12, No. 13, pp. 5181—5189 (1993), Exhibit Number 1187 filed in Interferences 106,007 and
`06,008 on February 17, 2015.
`
`ROOKE, Stanley T., Antisense Drug Technology, Principles, Strategies, and Applications, Marcel Dekker, Inc., New
`ork, Chapters 15 and 16, pages 375—389, 391—469 (2001) (Exhibit Number 2075 filed in interferences 106008,
`06013, 106007 on November 18, 2014)
`
`urriculum Vitae of Judith van Deutekom, Pages 6, Exhibit Number 1126 filed in interferences 106,007 and 106,008
`n Febmary17,2015_
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`urriculum Vitae, Erik Joseph Sontheimer, 18 pages, dated September 29, 2014 (Exhibit Number 1013 filed in
`nterferences 106008, 106007 on November 18,2014)
`
`V, Professor Matthew J.A. Wood, 3 pages (Exhibit Number 2003 filed in interferences 106008, 106007 on Novembe
`8, 2014)
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`—l0'14:00N
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`IAVIS, Richard J. et al., "Fusion of PAX7 to FKHR by the Variant t(1;13)(p36;q14) Translocation in Alveolar
`' habdomyosarcoma," Cancer Research, Vol. 54:2869—2872 (1994) (Exhibit Number 1027 filed in interferences
`06008, 106007 on November 18, 2014)
`
`—l ‘4
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`I E ANGELIS, Fernanda Gabriella et al., "Chimeric snRNA molecules carrying antisense sequences against the splice
`unctions of exon 51 of the dystrophic pre-mRNA induce exon skipping and restoration of a dystrophin synthesis in
`8—50 DMD cells," PNAS, Vol. 99(14):9456-9461 (2002)
`
`Iecision on Appeal, Ex Parte Martin Gleave and Hideaki Miyake, Appeal No. 2005—2447, Appl. No. 09/619,908
`January 31, 2006) (2009 WL 6927761 (Bd.Pat.App.& |nterf.), Pages 12, Exhibit Number 1207 filed in Interferences
`06,007 and 106,008 on February 17, 2015.
`
`EFS Web 2.1.17
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`

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`
`
`
`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
`.
`.
`( Not for submissmn under 37 CFR 1.99)
`
`Application Number 15789862
`
`Filing Date
`2017-10-20
`First Named Inventor
`Peter SAZANI
`
`Art U .
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`mt
`I N/A
`Examiner Name
`Not Yet Assigned
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` Attorney Docket Number
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`
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`I AVN-OOQDVCNT
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`Iecision on Request for ReHearing, Ex Parte Roderick John Scott, Appeal No. 2008-004077, Appl. No. 107058825
`January 6, 2010) (2010 WL 191079 (Bd.Pat.App. & |nterf.),Pages 21, Exhibit Number 1208 filed in Interferences
`06,007 and 106,008 on February 17, 2015.
`
`Ieclaration of Judith C.T. van Deutekom Under 37 CFR. §1.132, filed on January 27, 2012, in US. Patent
`eexamination Control No 90]011,320, regarding US. Patent No. 7,534,879, (University of Western Australia Exhibit
`' 133, filed April 3, 2015 in Interferences 106007, 106008, and 106013, pages 1—10).
`
`Ieclaration of Judith van Deutekom, Pages 45, Exhibit Number 1125 filed in interferences 106,007 and 106,008 on
`ebruary 17, 2015.
`
`I ELLORUSSO, Christiana et al., "Functional correction of adult mdx mouse muscle using gutted adenoviral vectors
`xpressing full—length dystrophin," PNAS, Vol. 99(20):12979—12984 (2002)
`
`Ieposition Transcript of Erik J. Sontheimer, PhD. of January 21, 2015 (99 pages), Exhibit Number 1215 filed in
`nterferences 106,007 and 106,008 on February 17, 2015.
`
`Ieposition Transcript of Matthew J. A. Wood, MD. , D. Phi|., January 22, 2015, including Errata Sheet, Pages 198,
`xhibit Number 1007 filed in Interference 106,013 on February 17, 2015.
`
`Ieposition Transcript of Matthew J. A. Wood, M.D., D. Phi|., Pages 196, Exhibit Number 1122 filed in interferences
`06,007 and 106,008 on February 17, 2015.
`
`Iesalting of Oligonucleotides, Pages 2, Exhibit Number 1132 filed in Interferences 106,007 and 106,008 on February
`
`I IRKSEN, Wessel P. et al., "Mapping the SFZIASF Binding Sites in the Bovine Growth Hormone Exonic Splicing
`nhancer," The Journal of Biological Chemistry, Vol. 275(37):29170—29177 (2000)
`
`IOMINSKI, Zbigniew et al., "Identification and Characterization by Antisense Oligonucleotides of Exon and lntron
`equences Required for Splicing," Molecular and Cellular Biology, Vol. 14(11):7445—7454 (1994)
`
`IOMINSKI, Zbigniew et al., "Restoration of correct splicing in thalassemic pre—mRNA by antisense Oligonucleotides,"
`'roc. Natl. Acad. Sci. USA, Vol. 90:8673—8677 (1993)
`
`|\JO
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`EFS Web 2.1.17
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`
`15789862
`
`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
`
`( Not for submission under 37 CFR 1.99)
`
`
`Filing Date
`2017-10-20
`First Named Inventor
`Peter SAZANI
`
`Art Unit
`|NIA
`
` Application Number
`
`Examiner Name
`Not Yet Assigned
`Attorney Docket Number
`
`IORAN, Philip et al., "Proteomic profiling of antisense—induced exon skipping reveals reversal of pathobiochemical
`: bnormalities in dystrophic mdx diaphragm," Proteomics, Vol. 9:671-685, DOI 10.10027pmic200800441 (2009)
`
`IOUGLAS, Andrew G.L. et al., "Splicing therapy for neuromuscular disease," Molecular and Cellular Neuroscience,
`0|. 56: 1 69—1 85 (2013) (Exhibit Number 2005 filed in interferences 106008, 106013, 106007 on November 18, 2014)
`
`onle, Donald F., et al. (2001) "Inhibition of Gene Expression Inside Cells by PeptideNucleic Acids: Effect of mRNA
`arget Sequence, Mismatched Bases, and PNA Length," Biochemistry 40:53—64, (Exhibit Number 2123 filed in
`nterferences 106,007 and 106,008 on February 17, 2015.
`
`I r. Wood Errata Sheet — 22 Jan 2015, Pages 2, Exhibit Number 1227 filed in Interferences 106,007 and 106,008 on
`ebruary 17, 2015.
`
`IUNCKLEY, Matthew G. et al., "Modification of splicingIn the dystrophin gene in cultured de muscle cells by
`:ntisense Oligoribonucleotides," Human Molecular Genetics, Vol. 5(1): 1083—1090 (1995)
`
`IUNCKLEY, Matthew G. et al., "Modulation of Splicing in the DMD Gene by Antisense Oligoribonucleotides,"
`ucleosides & Nucleotides, Vol. 16(7—9):1665—1668 (1997)
`
`CKSTEIN, F., "Nucleoside Phosphorothioates," Ann. Rev. Biochem, Vol. 54:367—402 (1985) (Exhibit Number 1028
`"ed in interferences 106008, 106007 on November 18, 2014)
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`EFS Web 2.1.17
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`LAYADI, Anissa N. et al., "Application of PNA and LNA oligomers to chemotherapy," Current Opinion in
`nvestigational Drugs, Vol. 2(4):558—561 (2001)
`
`mail from Danny Huntington to Interference Trial Section, dated September 21, 2014, Pages 2, Exhibit Number 3001
`"ed in Interference 106,007, 106,008, and 106,013 on September 26, 2014.
`
`mail From Sharon Crane to Interference Trial Section, dated November 13, 2014, Pages 2, Exhibit Number 3002 file
`n Interference 106,007, 106,008, and 106,013 on dated November 14, 2014.
`
`mery, A.E. H., "Population frequencies of inherited neuromuscular diseases — a world survey," Neuromuscul Disord
`991;1:19—29.
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`

`

`
`
`
`15789862
`
`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
`
`( Not for submission under 37 CFR 1.99)
`
`
`Filing Date
`2017-10-20
`First Named Inventor
`Peter SAZANI
`
`Art Unit
`|NIA
`
` Application Number
`
`Examiner Name
`Not Yet Assigned
`Attorney Docket Number
`
`|AVN-009DVCN7
`
`
`uropean Search Report for Application No. 121629950, 11 pages, dated January 15,2013
`
`
`rrata sheet for the January 22, 2015 deposition of Matthew J. A. Wood, M.D., D. PHIL., 2 pages, (Exhibit Number
`' 128 filed in interferences 106,007 and 106,008 on February 17, 2015.
`
`rrata sheet for the March 12, 2015 deposition of Erik J. Sontheimer, Ph.D., (University of Western Australia Exhibit
`' 149, filed April 3, 2015 in lnterferences 106007, 106008, and 106013, page 1).
`
`rrata to the Sarepta Briefing Information for the April 25, 2016 Meeting of the Peripheral and Central Nervous System
`Irugs Advisory Committee, Eteplirsen Errata Document, NDA 206488, 5 pages.
`
`RRINGTON, Stephen J. et al., "Target selection for antisense oligonucleotide induced exon skipping in the dystrophi
`ene," The Journal of Gene Medicine, Vol. 5:518—527 (2003)
`
`uropean Office Action for Application No. 097525729, 5 pages, dated February 29, 2012
`
`uropean Response, Application No. 100042746, 7 pages, dated November 5, 2013 (Exhibit Number 1060 filed in
`nterferences 106008, 106007 on November 18, 2014)
`
`uropean Response, Application No. 121985170, 7 pages, dated October 21, 2014 (Exhibit Number 2084 filed in
`nterferences 106008, 106013, 106007 on November 18, 2014)
`
`uropean Response, Application No. 131603383, 4 pages, dated June 26, 2014 (Exhibit Number 2085 filed in
`nterferences 106008, 106013, 106007 on November 18, 2014)
`
`uropean Search Report for Application No. 100042746, 12 pages, dated January 2, 2013
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`Application Number 15789862
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` Attorney Docket Number
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`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
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`.
`( Not for submissmn under 37 CFR 1.99)
`
`
`Filing Date
`2017-10-20
`First Named Inventor
`Peter SAZANI
`
`Art U .
`mt
`I N/A
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`Examiner Name
`Not Yet Assigned
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`
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`Application Number 15789862
`
`Filing Date
`2017-10-20
`First Named Inventor
`Peter SAZANI
`
`Art U .
`
`mt
`I N/A
`Examiner Name
`Not Yet Assigned
`I AVN-009DVCN7
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`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
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`FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria,
`VA 22313-1450.
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`Privacy Act Statement
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`The Privacy Act of 1974 (P.L. 93-579) requires that you be given certain information in connection with your submission of the
`attached form related to a patent application or patent. Accordingly, pursuant to the requirements of the Act, please be advised
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`is voluntary; and (3) the principal purpose for which the information is used by the U.S. Patent and Trademark Office is to
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`If you do not furnish the requested
`information, the U.S. Patent and Trademark Office may not be able to process andr'or examine your submission, which may
`result in termination of proceedings or abandonment of the application or expiration of the patent.
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`The information provided by you in this form will be subject to the following routine uses:
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`1.
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`The information on this form will be treated confidentially to the extent allowed under the Freedom of Information Act
`(5 U.S.C. 552) and the Privacy Act (5 U.S.C. 552a). Records from this system of records may be disclosed to the
`Department of Justice to determine whether the Freedom of Information Act requires disclosure of these record 5.
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`A record from this system of records may be disclosed, as a routine use, in the course of presenting evidence to a
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`A record in this system of records may be disclosed, as a routine use, to a Member of Congress submitting a
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`A record in this system of records may be disclosed, as a routine use, to a contractor of the Agency having need for
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`A record related to an International Application filed under the Patent Cooperation Treaty in this system of records
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`A record in this system of records may be disclosed, as a routine use, to another federal agency for purposes of
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`A record from this system of records may be disclosed, as a routine use, to the Administrator, General Services, or
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`A record from this system of records may be disclosed, as a routine use, to the public after either publication of
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`may be disclosed, subject to the limitations of 37 CFR 1.14, as a routine use, to the public if the record was filed in
`an application which became abandoned or in which the proceedings were terminated and which application is
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`A record from this system of records may be disclosed, as a routine use, to a Federal, State, or local law
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`EFS Web 2.1.17
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