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`Receiptdajze; 10/10/2013
`15/789j52 —GAU: 1574
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`Application Number
`15789862
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`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
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`( Not for submission under 37 CFR 1.99)
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`Filing Date
`2017—10-20
`First Named Inventor
`Peter SAZANI
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`Examiner Name
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`|AVN-009DVCN7
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`
`uropean Search Report, EP15168694.6, dated July 23, 2015, pages 1-8.
`
`xcerpts from Prosecution History of Application No. 13fl41,150: Notice of Allowance dated March 16, 2015; List of
`eferences cited by Applicant and Considered by Examiner; Notice of Allowance and Fees due dated September 18,
`'014; Amendment in Response to Non—Final Office Action dated July 11, 2014, (Academisch Ziekenhuis Leiden
`xhibit 1229, filed April 3, 2015 in Interference 106007 and 106008, pages 1—133).
`
`xcerpts from Prosecution History of Application No. 13/826,880: Notice of Allowance dated January 26, 2015 and
`‘ mendment in Response to Non-Final Office Action dates October 15, 2014, (Academisch Ziekenhuis Leiden Exhibit
`228, filed April 3, 2015 in Interference 106007 and 106008, pages 1—16).
`
`xcerpts from Yeo (Ed.), "Systems Biology of RNA Binding Proteins," Adv. Exp. Med. Biol., Chapter 9, 56 pages
`2014), (Academisch Ziekenhuis Leiden Exhibit 1232, filed April 3, 2015 in Interference 106007 and 106008, pages
`—56).
`
`xcerpts of SEC Form 8-K, dated November 23 2014, for BioMarin Pharmaceutical Inc., (University of Western
`‘ ustralia Exhibit 2129,
`filed April 3, 2015 in Interferences 106007, 106008, and 106013, pages 1—9).
`
`xon 46 Sequence of Dystrophin, Document D18 as filed in Opposition of European Patent EP1619249, filed June 23,
`'009, 1 page
`
`xon 51 Internal Sequence Schematic, Pages 1, Exhibit Number 1224 filed in Interferences 106,007 and 106,008 on
`ebruary 17, 2015.
`
`xon 53 Internal Sequence Schematic, Pages 1, Exhibit Number 1225 filed in Interferences 106,007 and 106,008 on
`ebruary 17, 2015.
`
`xtended European Search Report, EP 151903416, dated April 28, 2016, 9 pages.
`
`xtended European Search Report, EP 161723549, dated January 23, 2017, 7 pages.
`
`xtended European Search Report, EP 171593288, dated September 5, 2017, 10 pages.
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`Receiptdajze; 10/10/2013
`15/789j52 —GAU: 1574
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`Application Number
`15789862
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`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
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`( Not for submission under 37 CFR 1.99)
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`Filing Date
`2017-10-20
`First Named Inventor
`Peter SAZANI
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`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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`(A)N
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`4:.
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`—l—l"NlU'i
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`—l—l
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`—l
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`airclough et al., "Therapy for Duchenne muscular dystrophy: renewed optimism from genetic approaches," Nature
`eviews, Vol. 14, pp. 373-378 (June, 2013), Exhibit Number 1112 filed in interferences 106,007 and 106,008 on
`ebruary 17, 2015.
`
`ALL, Abbie M. et al., "Induction of revertant fibres in the mdx mouse using antisense oligonucleotides," Genetic
`accines and Therapy, Vol. 4:3, doi:10.1186/1479—0556-4—3, 12 pages (2006)
`
`DA Briefing Document, "Peripheral and Central Nervous System," Drugs Advisory Committee Meeting, NDA 206488
`teplirsen, Food and Drug Administration, pages 1—73, January 22, 2016.
`
`DA Briefing Information for the April 25, 2016 Meeting of the Peripheral and Central Nervous System Drugs Advisory
`ommittee, Eteplirsen, NDA 206488, 115 pages
`
`DA News Release, "FDA grants accelerated approval to first drug for Duchenne muscular dystrophy," September 19,
`'016, 3 pages.
`
`ederal Register, Vol. 58, No. 183, pp. 49432-49434, September 23, 1993 (6 pages); [Cited as: 58 FR 49432-01, 1993
`L 371451 (F.R.)], Exhibit Number 1221 filed in Interferences 106,007 and 106,008 on February 17, 2015.
`
`ederal Register, Vol. 69, No. 155, pp. 49960-50020 dated August 12, 2004 (62 pages), Exhibit Number 1220 filed in
`nterferences 106,007 and 106,008 on February 17, 2015.
`
`EEN ER, 0. et al., "Altemative splicing of human dystrophin mRNA generates isoforms at the carboxy terminus,"
`ature, vol. 338:509 — 511 (1989).
`
`|\J|\J—‘O
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`|\JN
`
`ile Excerpt from AZL US. Patent Application 11l233,495: Amendment After Non—Final Office Action, as—filed
`ovember 1, 2010 (Exhibit Number 1085 filed in interferences 106008, 106007 on December 23, 2014)
`
`ile Excerpt from AZL US. Patent Application 11l233,495: Claims examined in Non-Final Office Action, dated
`December 1, 2008 (Exhibit Number 1079 filed in interferences 106008, 106007 on December 23, 2014)
`
`ile Excerpt from AZL US. Patent Application 11l233,495: Final Office Action dated August 31, 2010 (Exhibit Number
`086 filed in interferences 106008, 106007 on December 23, 2014)
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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
`2017-10-20
`First Named Inventor
`Peter SAZANI
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`ile Excerpt from US Patent Application 11/233,495: Non-Final Office Action dated December 1, 2008 and Final
`office Action dated June 25, 2009 (Exhibit Number 1078 filed in interferences 106008, 106007 on December 23, 2014
`
`ile Excerpt from US Patent Application No. 12/198,007: AZL's Preliminary Amendment and Response, as—filed
`ovember 7, 2008 (Exhibit Number 1075 filed in interferences 106008, 106007 on December 23, 2014)
`
`ile Excerpt from US Patent Application No. 12/976,381: AZL's First Preliminary Amendment, as—filed December 22,
`'010 (Exhibit Number 1076 filed in interferences 106008, 106007 on December 23,2014)
`
`ile Excerpts from Prosecution History of US. Patent Application No. 13/270,992 ("UWA's US. Patent 8,486,907),
`'ages 122, Exhibit Number 1006 filed in Interference 106,013 on February 17, 2015.
`
`
`
`ile Excerpts from US. Patent Application No. 11/233,495: Response to Non- Final Office Action, as filed July 26,
`0'11 (14 pages), Exhibit Number 1222 filed in Interferences 106,007 and 106,008 on February 17,2015.
`
`ile Excerpts from US. Patent Application No. 13/270,992 ("UWA's US Patent 8,486,907): NFOA, dated 7/30/2012;
`. pplicant—Initiated Interview Summary, dated 11/8/2012; Amendment, as filed January 30, 2013; NOA, dated 4/4/2013,
`xhibit Number 1118 (122 pages) filed in interferences 106,007 and 106,008 on February 17, 2015.
`
`Ianagan, W. Michael, et al., "A cytosine analog that confers enhanced potency to antisense oligonucleotides," Proc.
`at'l Acad. Sci. USA, Vol. 96, pp. 3513-3518 (March, 1999), Exhibit Number 1211 filed in Interferences 106,007 and
`06,008 on February 17, 2015.
`
`LANIGAN, Kevin M. et al., "Pharmacokinetics and safety of single doses of drisapersen in non-ambulant subjects
`ith Duchenne muscular dystrophy: Results of a double-blind randomized clinical trial," Neuromuscular Disorders, Vol.
`'4:16—24 (2014) (Exhibit Number 2038 filed in interferences 106008, 106013, 106007 on November 18, 2014)
`
`Ianigan, Kevin M., et al. (2003) "Rapid Direct Sequence Analysis of the Dystrophin Gene," Am. J. Hum. Genet.
`2:931—939, dated February 17, 2015 (Exhibit Number 2120 filed in interferences 106,007 and 106,008 on February
`7, 2015.
`
`letcher S., et al, "Morpholino oligomer—mediated exon skipping averts the onset of dystrophic pathology in the mdx
`ouse. Mol Ther 2007;15:1587—1592.
`
`LETCH ER, Sue et aI., "Dystrophin lsoform Induction In Vivo by Antisense—mediated Alternative Splicing," Molecular
`herapy, Vol. 18(6):1218—1223 (2010)
`
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`Receipt. date; Ill/WELT
`15/7&9,_8_62 — GAU: 1574
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`15789862
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`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
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`( Not for submission under 37 CFR 1.99)
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`Filing Date
`2017-10-20
`First Named Inventor
`Peter SAZANI
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`Art Unit
`|NIA
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` Application Number
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`Examiner Name
`Not Yet Assigned
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`Attorney Docket Number |AVN-009DVCNT
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`004:.
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`000'1
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`000')
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`4:-000000O(.003"-l
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`4:. _.
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`4:.N
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`4:.00
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`4:.4:.
`
`LETCHER, Sue et al., "Targeted Exon Skipping to Address 'Leaky' Mutations in the Dystrophin Gene," Molecular
`herapy—Nucleic Acids, Vol. 1, e48, doi:10.1038/mtna_2012_40, 11 pages (2012)
`
`LETCH ER, Susan et al., "Dystrophin expression in the mdx mouse after localised and systemic administration of a
`orpholino antisense oligonucleotide," J. Gene Med, Vol. 8:207—216 (2006)
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`isorders," Curr. Opin. Neur0l_, Vol. 13:553—560 (2000)
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`OSTER, Helen et al., "Genetic Therapeutic Approaches for Duchenne Muscular Dystrophy," Human Gene Therapy,
`ol. 23:676—687 (2012)
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`ourth Declaration of Erik Sontheimer, Ph_D. (Pursuant to Bd.R. 41 .155(b)(2) and SO 155.13 and 15514), dated
`arch 9, 2015, (University of Western Australia Exhibit 2138, filed April 3, 2015 in lnterferences 106007, 106008, and
`06013, pages 1-4).
`
`RAGALL, Clayton T. et al., "Mismatched single stranded antisense oligonucleotides can induce efficient dystrophin
`plice switching," BMC Medical Genetics, Vol. 12:141, 8 pages (2011) (Exhibit Number 2019 filed in interferences
`06008, 106013, 106007 on November 18, 2014)
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`ucleic acids," Trends Biochem_, Vol. 6:77—80 (1981)
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`RAZIER, Kendall S. et al., "Species-specific Inflammatory Responses as a Primary Component for the Development
`f Glomerular Lesions in Mice and Monkeys Following Chronic Administration of a Second—generation Antisense
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`
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`EBSKI, Bianca L. et al., "Morpholino antisense oligonucleotide induced dystrophin exon 23 skipping in mdx mouse
`uscle," Human Molecular Genetics, Vol. 12(15):1801-1811 (2003)
`
`enBank AF213437_1 Dated January 17, 2002
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`15789862
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`Filing Date
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`First Named Inventor
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`eneric Method for Average Mass Determination Using LC-UV—MS in the Negative Mode, Pages 15, Exhibit Number
`145 filed in Interferences 106,007 and 106,008 on February 16, 2015.
`
`06008, 106013, 106007 on November 18, 2014)
`
`eneric UPLC Purity Method for Oligonucleotides (19— to 25—mers), Pages 18, Exhibit Number 1156 filed in
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`. ntisense & Nucleic Acid Drug Development, Vol. 9:213-220 (1999)
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`nterferences 106,007 and 106,008 on February 17, 2015.
`
`IaxoSmithKline, "GSK and Prosensa announce start of Phase III study of investigational Duchenne Muscular
`Iystrophy medication," press release, 6 pages, dated January 19, 2011 (Exhibit Number 2060 filed in interferences
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`Receipt. date; 10/10/2013
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`15789862
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