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`IN FORMATION DISCLOSU RE
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`|i Lilly and Company
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`atsuo Masafumi
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`esearch Institute
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`ybn'don, Inc
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`he University of North
`arolina at Chapel Hill et
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`Receiptdajze; 111/10/21113
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`15/789,352 - GAU: 1574
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`15789862
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`IN FORMATION DISCLOSU RE
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`First Named Inventor Peter SAZANI
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`201 7-1 0-20
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`I N/A
`errara
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`06,008 on February 16, 2015.
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`NON-PATENT LITERATURE DOCUMENTS
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`Include name of the author (in CAPITAL LETTERS), title of the article (when appropriate), title of the item
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`.
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`(book, magazme, Journal, serial, symposium, catalog, etc), date, pages(s), volume-issue number(s),
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`publisher, City and/or country where published.
`
`T5
`
`i ON P81966 Mass Spectrometry Data, Pages 8, Exhibit Number 1154 filed in Interferences 106,007 and 106,008 on
`ebruary 16, 2015.
`
`i ON P81966 UPLC Data, Pages 2, Exhibit Number 1165 filed in Interferences 106,007 and 106,008 on February 16,
`
`i ON P81967 Mass Spectrometry Data, Pages 7, Exhibit Number 1155 filed in Interferences 106,007 and 106,008 on
`ebruary 16, 2015.
`
`i ON P81967 UPLC Data, Pages 2, Exhibit Number 1166 filed in Interferences 106,007 and 106,008 on February 16,
`
`i ON P8229 (h53AON1) HPLC Chromatograph Pages 2, Exhibit Number 1140 filed in lnterferences 106,007 and
`06,008 on February 16, 2015.
`
`i ON P8229 (h53AON1) HPLC Method Report, Pages 3, Exhibit Number 1139 filed in Interferences 106,007 and
`
`.
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`Examiner Cite
`.
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`*
`Initials
`No
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`1
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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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`Examiner Name
`Not Yet Assigned
`Attorney Docket Number
`|AVN-009DVCN7
`
`A ON P8229 (h53AON1) Mass Spectrometry Data, Pages 3, Exhibit Number 1142 filed in Interferences 106,007 and
`06,008 on February 16, 2015.
`
`A ON P8229 (h53AON1) Synthesis Laboratory Notebook Entry, Pages 1, Exhibit Number 1137 filed in Interferences
`06,007 and 106,008 on February 16, 2015.
`
`A ON P8229L (h53AON229L) Certificate of Analysis, Pages 1, Exhibit Number 1129 filed in Interferences 106,007 and
`06,008 on February 17, 2015.
`
`A ON P843 (h51AON1) Certificate of Analysis, Pages 1, Exhibit Number 1134 filed in Interferences 106,007 and
`06,008 on February 16, 2015.
`
`A ON P843 (h51AON1) HPLC Chromatogram, Pages 1, Exhibit Number 1131 filed in Interferences 106,007 and
`06,008 on February 17, 2015.
`
`A ON P843 (h51AON1) HPLC Method Report, Pages 4, Exhibit Number 1130 filed in Interferences 106,007 and
`06,008 on February 17, 2015.
`
`
`
`A ON P843 (h51AON1) Mass Spectrometry Data, Pages 3, Exhibit Number 1135 filed in Interferences 106,007 and
`06,008 on February 16, 2015.
`
`A ON P843 (h51AON1) UPLC—UV Data, Pages 2, Exhibit Number 1136 filed in Interferences 106,007 and 106,008 on
`ebruary 16, 2015.
`
`A ONs P81958, PS1959, P81960, P81961, P81962, P81963, P81964, PS1965, P81966, and P8196? HPLC Method
`eport, Pages 3, Exhibit Number 1143 filed in Interferences 106,007 and 106,008 on February 16, 2015.
`
`A pplicant—Initiated Interview Summary dated April 8, 2013 in US Application Serial No. 131094548, (University of
`estern Australia Exhibit 2144, filed April 3, 2015 in Interferences 106007, 106008, and 106013, pages 1—11).
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`A rechavala—Gomeza V, et al., "Immunohistological intensity measurements as a tool to assess sarcolemma—associated
`rotein expression," Neuropathol Appl Neurobiol 2010,36: 265-74.
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`‘4
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`EFS Web 2.1.1?
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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
`
`
`
`
`
`
`Examiner Name
`Not Yet Assigned
`Attorney Docket Number
`|AVN-009DVCN7
`
`A RECHAVALA—GOMEZA, V. et al., "Comparative Analysis of Antisense Oligonucleotide Sequences for Targeted
`kipping of Exon 51 During Dystrophin Pre-mRNA Splicing in Human Muscle," Human Gene Therapy, Vol. 18:798-81l
`
`A RORA, Vikram et al., "c—Myc Antisense Limits Rat Liver Regeneration and Indicates Role for c—Myc in Regulating
`ytochrome P-450 3A Activity," The Journal of Pharmacology and Experimental Therapeutics, Vol. 292(3):921—928
`2000)
`
`A setek Danmark AIS v. CMI USA, Inc., 2014 WL 5990699, N_D. Cal. 2014, 8 pages, (Academisch Ziekenhuis Leiden
`xhibit 1237, filed May 5, 2015 in Interference 106007 and 106008).
`
`A SVADI, Parisa et al., "Expression and functional analysis of recombinant scFv and diabody fragments with specificity
`or human RhD," Journal of Molecular Recognition, Vol. 15:321-330 (2002)
`
`
`
`A ustralian Application No. 2004903474, 36 pages, dated July 22, 2005 (Exhibit Number 1004 filed in interferences
`06008, 106007 on November 18, 2014)
`
`AVI BioPharma, |nc., "Exon 51 Sequence of Dystrophin," Document D19 as filed in Opposition of European Patent
`P1619249, filed June 23, 2009, 7 pages
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`A L's PCT/NL03700214 (the as—filed AZL PCT Application) Exhibit No. 1006, filed in Interference No. 106,007, 64
`ages, December 23, 2014
`
`A L's US. Patent Application No. 14/295,311 and claims, as—filed June 3, 2014 ("the '311 Application") (Exhibit
`umber 1077 filed in interferences 106008, 106007 on December 23, 2014)
`
`A ofeifa J, et al., "X—chromosome methylation in manifesting and healthy carriers of dystrophinopathies: concordance
`f activation ratios among first degree female relatives and skewed inactivation as cause of the affected phenotypes,"
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`: EAUCAGE, S.L_ et al., "Deoxynucleoside Phosphoramidites - A New Class of Key lntennediates for
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`: ELLARE, Priya et al., "A role for ubiquitin in the spliceosome assembly pathway," Nature Structural & Molecular
`.iology, Vol. 15(5):444—451 (2008) (Exhibit Number 1057 filed in interferences 106008, 106007 on November 18,
`
`
`
`|\JO
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`—|
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`|\J|\J|\J|\J|\J
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`|\J|\J"-l0')
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`|\JCO
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`EFS Web 2.1.17
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`Receipt. date; Ill/MUM
`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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`
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`Filing Date
`2017-10-20
`First Named Inventor
`Peter SAZANI
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`|NIA
`
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`
`
`
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`Not Yet Assigned
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`Attorney Docket Number |AVN-009DVCN7
`
`|\J(D
`
`00O
`
`00 _.
`
`0000000000
`
`00-..4
`
`00CO
`
`00(D
`
`: ELLARE, Priya et al., "Ubiquitin binding by a variant Jab1IMPN domain in the essential pre-mRNA splicing factor
`rp8p," RNA, Vol. 12:292-302 (2006) (Exhibit Number 1056 filed in interferences 106008,106007 on November 18,
`
`: ENNETT, C. Frank et al., "RNA Targeting Therapeutics: Molecular Mechanisms of Antisense Oligonucleotides as a
`herapeutic Platform," Annu. Rev. Pharmacol. Toxicol., Vol. 50:259—293 (2010) (Exhibit Number 1025 filed in
`nterferences 106008, 106007 on November 18,2014)
`
`: ERGE, Stephen M. et al., "Pharmaceutical Salts," Journal of Pharmaceutical Sciences, Vol. 66(1):1-18 (1977)
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`: estas et al., "Design and Application of Bispecific Splice Switching Oligonucleotides," Nuc. Acid Therap., Vol. 24, No.
`, pp. 13—24 (2014), Exhibit Number 1120 filed in interferences 106,007 and 106,008 on February 17, 2015.
`
`RAASCH, Dwaine A. et al., "Locked nucleic acid (LNA): fine-tuning the recognition of DNA and RNA," Chemistry &
`iology, Vol. 8:1—7 (2001) (Exhibit Number 2009 filed in interferences 106008, 106013, 106007 on November 18, 2014
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`RAASCH, Dwaine A. et al., "Novel Antisense and Peptide Nucleic Acid Strategies for Controlling Gene Expression,"
`. iochemistry, Vol. 41(14):4503-4510 (2002) (Exhibit Number 2006 filed in interferences 106008, 106013, 106007 on
`ovember 18, 2014)
`
`: REMMER—BOUT, Mattie et al., "Targeted Exon Skipping in Transgenic hDMD Mice: A Model for Direct Preclinical
`creening of Human-Specific Antisense Oligonucleotides," Molecular Therapy, Vol. 10(2):232—240 (2004) (Exhibit
`umber 2024 filed in interferences 106008, 106013, 106007 on November 18, 2014)
`
`: rooke MH, et al., "Clinical investigation in Duchenne dystrophy: 2. Determination of the "power" of therapeutic trials
`ased on the natural history," Muscle Nerve. 1983;6:91—103.
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`: ROWN, Susan C. et al., "Dystrophic phenotype induced in vitro by antibody blockade of muscle alpha-dystroglycan—
`aminin interaction," Journal of Cell Science, Vol. 112:209—21 6 (1999)
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`harrnacological and psychosocial management," Lancet Neurol 2010;9:77—93.
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`: ushby KM, et al., "The clinical, genetic and dystrophin characteristics of Becker muscular dystrophy," |l. Correlation o
`henotype with genetic and protein abnormalities. J Neurol 1993;240: 105—112.
`
`EFSWeb2.1.17
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`Application Number
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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
`
`Art Unit
`|NIA
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`Examiner Name
`Not Yet Assigned
`Attorney Docket Number
`|AVN-009DVCN7
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`
`
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`4:.
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`4:-4:-4:-N—‘O
`4:-4:-4:---.|o)(It4:00
`4:-4:-4:-(D03
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`: ushby KM, et al., "The clinical, genetic and dystrophin characteristics of Becker muscular dystrophy," |. Natural
`istory. J Neurol 1993;240:98—104.
`
`ANONICO, A.E_ et al., "Expression of a CMV Promoter Drive Human alpha—1 Antitrypsin Gene in Cultured Lung
`ndothelial Cells and in the Lungs of Rabbits," Clinical Research, Vol. 39(2):219A (1991)
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`IRAK, Sebahattin et al., "Exon skipping and dystrophin restoration in patients with Duchenne muscular dystrophy
`-fter systemic phosphorodiamidate morpholino oligomer treatment: an open—label, phase 2, dose—escalation study,"
`ancet, Vol. 378(9791):595—605 (2011)
`
`laim Chart 11/233,495, Pages 57, Exhibit Number 1216 filed in Interferences 106,007 and 106,008 on February 17,
`
`laim Chart 13/550,210, Pages 45, Exhibit Number 1217 filed in Interferences 106,007 and 106,008 on February 17,
`
`laim Chart, US 7,807,816, 14 pages (Exhibit Number 1063 filed in interferences 106008, 106007 on November 18,
`
`laim Chart, US 7,960,541, 17 pages (Exhibit Number 1064 filed in interferences 106008, 106007 on November 18,
`
`laim Chart, US 8,455,636, 32 pages (Exhibit Number 1062 filed in interferences 106008, 106007 on November 18,
`
`laim Comparison Chart — Claims 11 and 29 in 13/550,210, Pages 1, Exhibit Number 1226 filed in Interferences
`06,007 and 106,008 on February 17,2015.
`
`laim Comparison Chart 13/550,210 vs 11/233,495, Pages 12, Exhibit Number 1218 filed in Interferences 106,007 an
`06,008 on February 17, 2015.
`
`(.71O
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`laim Comparison Chart 13/550,210 vs 12/ 198,007, Pages 1, Exhibit Number 1219 filed in Interferences 106,007 and
`06,008 on February 17, 2015.
`
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`15/739,_8_62 — GAU: 1574
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`IN FORMATION DISCLOSU RE
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`First Named Inventor
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`| AVN-OOQDVCNT
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`Filing Date
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` Attorney Docket Number
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`15/7&9,_8_62 — GAU: 1574
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`15789862
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`IN FORMATION DISCLOSU RE
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