`Remipi; data; 1222;123:115
`iii/343,778 - GAE}: 1574
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`15349778
`
`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
`
`( Not for submission under 37 CFR 1.99)
`
`
`Filing Date
`2016-11-11
`First Named Inventor
`Peter SAZANI
`
`Art Unit
`|1502
`
` Application Number
`
`
`
`Examiner Name
`Not Yet Assigned
`
`Attorney Docket Number |AVN-009DVCN6
`
`|\J00
`
`|\Ja
`
`|\JUt
`
`00|\J|\J|\J|\JO(.003"-l0')
`
`00 _.
`
`00N
`
`0000
`
`.tandard Operating Procedure FPLC Desalting, Pages 6, Exhibit Number 1144 filed in Interferences 106,007 and
`06,008 on February 16, 2015.
`
`.tanton, Robert et al., "Chemical Modification Study of Antisense Gapmers", Nucleic Acid Therapeutiw, Vol. 22(5):
`544—359 (2012)
`
`.tatement On A Nonproprietary Name Adopted By the USAN Council, ETEPLIRSEN, Chemical Structure, 2010,
`
`TEIN, CA, "Delivery of antisense oligonucleotides to cells: a consideration of some of the barriers," Monographic
`upplement sen'es: Oligos & Peptides - Chimica Oggi - Chemistry Today, Vol. 32(2):4—7 (2014) (Exhibit Number 2022
`"ed in interferences 106008, 106013, 106007 on November 18, 2014)
`
`.TEIN, Cy A. et al., "Therapeutic Oligonucleotides: The Road Not Taken," Clin. Cancer Res, Vol. 17(20):6369-6372
`2011) (Exhibit Number 2026 filed in interferences 106008, 106013, 106007 on November 18, 2014)
`
`.TEIN, David et al., "A Specificity Comparison of Four Antisense Types: Morpholino, 2'-O—Methyl RNA, DNA, and
`' Hosphorothioate DNA," Antisense 8 Nucleic Acid Drug Development, Vol. 7:151—157 (1997)
`
`
`
`trober JB, "Therapeutics in Duchenne muscular dystrophy," NeuroRX 2006; 3:225—34.
`
`.ummary of Professional Experience (Dr. Erik J. Sontheimer), Pages 4, Exhibit Number 1223 filed in Interferences
`06,007 and 106,008 on February 17, 2015.
`
`.UMMERTON, James et al., "Morpholino and Phosphorothioate Antisense Oligomers Compared in Cell-Free and In-
`ell Systems," Antisense & Nucleic Acid Drug Development, Vol. 7:63-70 (1997)
`
`.. UMMERTON, James et al., "Morpholino Antisense Oligomers: Design, Preparation, and Propelties," Antisense &
`ucleic Acid Drug Development, Vol. 7:187—195 (1997)
`
`. UMMERTON, James, "Morpholino antisense Oligomers: the case for an Rnase H-independent structural type,"
`. iochimica et Biophysica Acta, Vol. 1489:141—158 (1999) (Exhibit Number 1038 filed in interferences 106008, 106013,
`06007 on November 18, 2014)
`
`EFSWeb2.1.17
`
`ALL REFERENCES CONSIDERED EXCEFT WHERE LINED THROUGH.
`
`/JPM/
`
`
`
`
`
`
`Remipi; data; 1222;123:115
`iii/343,778 - GAE}: 1574
`
`15349778
`
`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
`
`( Not for submission under 37 CFR 1.99)
`
`
`Filing Date
`2016-11-11
`First Named Inventor
`Peter SAZANI
`
`Art Unit
`|1502
`
` Application Number
`
`
`
`Examiner Name
`Not Yet Assigned
`
`Attorney Docket Number |AVN-009DVCN6
`
`00a
`
`000'1
`
`000')
`
`4:-000000O(.003"-I
`
`h A
`
`hN
`
`h00
`
`gp
`
`upplementary European Search Report for Application No. 108293671, 8 pages, dated May 22, 2013
`
`uter et al., "Double-target antisense U7 snRNAs promote efficient skipping of an aberrant exon in three human Beta—
`halassemic mutations," 8:13 HUMAN MOLECULAR GENETICS 2415-2423 (1999) (Exhibit Number 1083 filed in
`nterferences 106008, 106007 on December 23,2014)
`
`HOEN, Peter A.C. et al., "Generation and Characterization of Transgenic Mice with the Full—length Human DMD
`ene," The Journal of Biological Chemistry, Vol. 283(9):5899—5907 (2008) Exhibit Number 2030 filed in interferences
`06008, 106013, 106007 on November 18, 2014)
`
`able 1: Primer and Product Details for Exon 51 and 53 Reports on AONs of 20 to 50 Nucleotides dd 07 JAN 2015,
`'ages 1, Exhibit Number 1177 filed in Interferences 106,007 and 106,008 on February 16,2015.
`
`akeshima et al., "Oligonucleotides against a splicing enhancer sequence led to dystrophin production in muscle cells
`rom a Duchenne muscular dystrophy patient," Brain & Dev., Vol. 23, pp. 788—790 (2001 ), Exhibit Number 1196 filed in
`nterferences 106,007 and 106,008 on February 17, 2015.
`
`AKESHIMA, Yasuhiro et al., "Modulation of In Vitro Splicing of the Upstream lntron by Modifying an lntra—Exon
`equence Which Is Deleted from the Dystrophin Gene in Dystrophin Kobe," J. Clin. Invest, Vol. 95:515-520 (1995)
`
`
`
`ANAKA, Kenji et al., "Polypurine Sequences within a Downstream Exon Function as a Splicing Enhancer," Molecular
`nd Cellular Biology, Vol. 14(2):1347—1354 (1994)
`
`elios Pharms., Inc. v. Merck KgaA, No. 96-1307, 1998 WL 35272018 (S.D. Cal. Nov. 18, 1998), 11 pages (Exhibit
`umber 2153 filed in interference 106013 on October 29, 2015)
`
`HANH, Le Thiet et al., "Characterization of Revertant Muscle Fibers in Duchenne Muscular Dystrophy, Using Exon-
`pecific Monoclonal Antibodies against Dystrophin," Am. J. Hum. Genet, Vol. 56:725—731 (1995)
`
`he Regents of the University of California v. Dako North America, Inc., U.S.D.C., N.D. California, No. COS—03955
`HP, April 22, 2009 (2009 WL 1083446 (N.D.Cal.), Exhibit Number 1206 filed in Interferences 106,007 and 106,008
`n February 17, 2015.
`
`IAN, Xiaobing et al., "Imaging Oncogene Expression," Ann. NY. Acad. Sci, Vol. 1002:165—188 (2003) (Exhibit
`umber 2029 filed in interferences 106008, 106013, 106007 on November 18, 2014)
`
`EFSWeb2.1.17
`
`ALL REFERENCES CONSIDERED EXCEFT WHERE LINED THROUGH.
`
`/JPM/
`
`
`
`
`
`
`Remipi; data; 1222;123:115
`iii/343,778 - GAE}: 1574
`
`15349778
`
`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
`
`( Not for submission under 37 CFR 1.99)
`
`
`Filing Date
`2016-11-11
`First Named Inventor
`Peter SAZANI
`
`Art Unit
`|1502
`
` Application Number
`
`Examiner Name
`Not Yet Assigned
`
`Attorney Docket Number |AVN-009DVCN6
`
`
`
`
`
`ranscript of 2nd Deposition of Erik J. Sontheimer, Ph.D., dated March 12, 2015, (Academisch Ziekenhuis Leiden
`xhibit 1231, filed April 3, 2015 in Interference 106007 and 106008, pages 1-185).
`
`ranscript of 2nd Deposition of Matthew J.A. Wood, M.D., D. Phil, dated March 5, 2015, (Academisch Ziekenhuis
`eiden Exhibit 1230, filed April 3, 2015 in Interference 106007 and 106008, pages 1—117).
`
`ranscript of December 12,2014 Teleconference with Administrative Patent Judge Schafer (rough draft) (previously
`fled in Int. No. 106,008 as Ex. 2114), Pages 28 Exhibit Number 1001 filed in Interference 106,013 on February 17,
`
`ranscript of the January 21, 2015 deposition of Erik Sontheimer, Ph.D., Patent Interference Nos. 106,007 and
`06,008, 98 pages, dated January 21, 2015 (Exhibit Number 2122 filed in interferences 106,007 and 106,008 on
`ebruary 17, 2015.
`
`ranscript of the March 11, 2015 deposition of Judith van Deutekom, Ph.D., (University of Western Australia Exhibit
`' 141, filed April 3, 2015 in lnterferences 106007, 106008, and 106013, pages 1—168).
`
`"ed April 3, 2015 in lnterferences 106007, 106008, and 106013, pages 1—183).
`
`ranscript of the March 12, 2015 deposition of Erik J. Sontheimer, Ph.D., (University of Western Australia Exhibit 2142
`
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`EXAMINER SIGNATURE
`
`Examiner Signature I [Jennifer Pitrak Menonalrj/
`
`Date Considered
`
`I 03/08/2018
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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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`/JPM/
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