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`niversita Delgi Studi Di
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`ecklenburg Hospital
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`15/739,_8_62 — GAU: 1574
`Receiptdajze; 111/1Q/2Q13
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`Application Number
`15789862
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`IN FORMATION DISCLOSU RE
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`First Named Inventor
`Peter SAZANI
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`Filing Date
`2017-10-20
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`STATEMENT BY APPLICANT
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`A_\
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`2012—01—05
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`agiwara, Masatoshi et
`I.u
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`201 3—07—04
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`3
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`3fl--fl--- 2013—09—26
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`2014—01—09
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`
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`ippon Shinyaku 00.,
`td. et al.
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`ippon Shinyaku 00., Ltd
`
`he Charlotte-
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`ecklenburg Hospital
`. uthority DIBIA
`
`- vi Biopharma, Inc
`
`he Regents of the
`niversity of California
`
`- ssociation Institut De
`
`yologie et al.
`
`ippon Shinyaku 00.,
`td. et al.
`
`' rosensa Technologies
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`' rosensa Technologies
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`arepta Therapeutics, Inc
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`15/739,_8_62 — GAU: 1574
`Receiptdajze; 111/1Q/2Q13
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`Application Number
`15789862
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`
`Filing Date
`2017-10-20
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`First Named Inventor
`Peter SAZANI
`
` Attorney Docket Number
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`IN FORMATION DISCLOSU RE
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`STATEMENT BY APPLICANT
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`( Not for submission under 37 CFR 1.99)
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`Ui
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`A_\
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`2014—06—26
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`arepta Therapeutics, Inc
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`1993—10—14
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`1 994—02—03
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`1994—1 1—24
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`1996—04—1 1
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`1996—04—1 1
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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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`
`
`arepta Therapeutics, Inc
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`D
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`- bbott Laboratories
`
`'harmaceuticals, Inc.
`
`he University of North
`arolina at Chapel Hill
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`he University of British
`olumbia
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`he University of British
`olumbia
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`15789862
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`IN FORMATION DISCLOSU RE
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`( Not for submission under 37 CFR 1.99)
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`Filing Date
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`NON-PATENT LITERATURE DOCUMENTS
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`Examiner Cite
`|nitials*
`No
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`2
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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
`
`laims from US Application No. 11I233,495, 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, CA. at 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.
`
`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.
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`6
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`7
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`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.
`
`EFSWeb2.1.17
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`Receiptdajze; 10/10/2013
`15/789j52 —GAU: 1574
`
`Application Number
`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
`
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`
`
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`Examiner Name
`Not Yet Assigned
`Attorney Docket Number
`|AVN-009DVCN7
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`—l
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`—lU14:00N
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`—l
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`—l
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`EFS Web 2.1.17
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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)
`
`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_
`
`
`
`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)
`
`IAVIS, Richard J. et al., "Fusion of PAXT 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)
`
`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.
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`Receiptdajze; 10/10/2013
`15/789j52 —GAU: 1574
`
`Application Number
`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
`
`
`
`
`
`
`Examiner Name
`Not Yet Assigned
`Attorney Docket Number
`|AVN-009DVCN7
`
`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 90101 1,320, regarding US. Patent No. 7,534,879, (University of Western Australia Exhibit
`' 133, filed April 3, 2015 in lnterferences 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 lnterferences 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):?445—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)
`
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`|\JO
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`|\J|\J|\J|\J|\J
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`|\J|\JCO"-4
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`|\J(D
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`EFS Web 2.1.17
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`Receipt. date; Ill/MUM
`15/739,352 — GAU: 1574
`
`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
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`00O
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`00 _.
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`00N
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`0000000000
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`00CO
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`00(D
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`4:.O
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`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 PeptideNucIeic 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)
`
`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.
`
`EFSWeb2.1.17
`
`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`15/7&9,_8_62 — GAU: 1574
`Receiptdajze; 111/10/2013
`
`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
`
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`liill
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`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
`
`uropean Search Report for Application No. 121629950, 11 pages, dated January 15,2013
`
`
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`15/739,_8_62 — GAU: 1574
`Receiptdajze; 111/1Q/2Q13
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`Application Number
`15789862
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`Filing Date
`2017-10-20
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` Attorney Docket Number
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`IN FORMATION DISCLOSU RE
`
`STATEMENT BY APPLICANT
`
`( Not for submission under 37 CFR 1.99)
`
`First Named Inventor
`Peter SAZANI
`
`Art Unit
`| MIA
`
`Examiner Name
`Not Yet Assigned
`I AVN-OOQDVCNT
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`Examiner Signature I
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`[Jennifer Pitrak McDonald/
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`EXAMINER SIGNATURE
`
`Date Considered
`
`I 12/12/2017
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`*EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609. Draw line through a
`citation if not in conformance and not considered.
`Include copy of this form with next communication to applicant.
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`1 See Kind Codes of USPTO Patent Documents at www.USPTO.GOV or MPEP 901.04. 2 Enter office that issued the document, by the two-letter code (WIPO
`Standard ST.3). 3 For Japanese patent documents, the indication of the year of the reign of the Emperor must precede the serial number of the patent document.
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`English language translation is attached.
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`EFS Web 2.1.17
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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`Receipt. date; 10/10/2013
`15/7&9,_8_62 — GAU: 1574
`
`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
`
`
`
`
`
`Please see 37 CFR 1.97 and 1.98 to make the appropriate selection(s):
`
`CERTIFICATION STATEMENT
`
`That each item of information contained in the information disclosure statement was first cited in any communication
`from a foreign patent office in a counterpart foreign application not more than three months prior to the filing of the
`information disclosure statement. See 37 CFR 1.97(e)(1).
`
`OR
`
`That no item of information contained in the information disclosure statement was cited in a communication from a
`
`foreign patent office in a counterpart foreign application, and, to the knowledge of the person signing the certification
`after making reasonable inquiry, no item of information contained in the information disclosure statement was known to
`any individual designated in 37 CFR 1.56(c) more than three months prior to the filing of the information disclosure
`statement. See 37 CFR 1.97(e)(2).
`
`El
`
`See attached certification statement.
`
`The fee set forth in 37 CFR 1.17 (p) has been submitted herewith.
`
`A certification statement is not submitted herewith.
`
`SIGNATURE
`
`A signature of the applicant or representative is required in accordance with CFR 1.33, 10.18. Please see CFR 1.4(d) for the
`form of the signature.
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`This collection of information is required by 37 CFR 1.97 and 1.98. The information is required to obtain or retain a benefit by the
`public which is to file (and by the USPTO to process) an application. Confidentiality is governed by 35 U.S.C. 122 and 37 CFR
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`Patent and Trademark Office, U.S. Department of Commerce, PO. Box 1450, Alexandria, VA 22313-1450. DO NOT SEND
`FEES OR COMPLETED FORMS TO THIS ADDRESS. SEND TO: Commissioner for Patents, P.O. Box 1450, Alexandria,
`VA 22313-1450.
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`EFSWeb2.1.17
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`ALL REFERENCES CONSIDERED EXCEPT WHERE LINED THROUGH.
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` NamelPrint
`Signature
`2017—10—30
`
`
`
`

`

`Receipt date: 10/30/2017
`
`15/789,862 - GAU: 1674
`
`Privacy Act Statement
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`EFS Web 2.1.17
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