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`Application Number 15349778
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`Filing Date
`2016-11-11
`First Named Inventor
`Peter SAZANI
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`Art U .
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`nit
`I 1674
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`”iverfita Deg." Stuf,“ di
`oma La Sapienza
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`010,150231
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`2010_12_29
`
`niversita Degli Studi di
`errara
`
`' 011/024077
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`Examiner Cite
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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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`publisher, City and/or country where published.
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`T5
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`1
`
`i ON PS1966 Mass Spectrometry Data, Pages 8, Exhibit Number 1154 filed in Interferences 106,007 and 106,008 on
`ebruary 16, 2015.
`
`
`
`
`
`2
`
`3
`
`i ON PS1966 UPLC Data, Pages 2, Exhibit Number 1165 filed in Interferences 106,007 and 106,008 on February 16,
`
`i ON PS1967 Mass Spectrometry Data, Pages 7, Exhibit Number 1155 filed in Interferences 106,007 and 106,008 on
`ebruary 16, 2015.
`
`
`
`4
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`i ON PS1967 UPLC Data, Pages 2, Exhibit Number 1166 filed in Interferences 106,007 and 106,008 on February 16,
`
`
`
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`
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`
`5
`
`6
`
`i ON PS229 (h53AON1) HPLC Chromatograph Pages 2, Exhibit Number 1140 filed in lnterferences 106,007 and
`06,008 on February 16, 2015.
`
`i ON PS229 (h53AON1) HPLC Method Report, Pages 3, Exhibit Number 1139 filed in Interferences 106,007 and
`06,008 on February 16, 2015.
`
`
`
`EFS Web 2.1.17
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`

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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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`Application Number 15349778
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`Filing Date
`2016-11-11
`First Named Inventor
`Peter SAZANI
`
`Art U .
`
`mt
`I 1674
`Examiner Name
`Not Yet Assigned
`
` Attorney Docket Number
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`
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`—l—l54(A)N
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`I AVN-OOQDVCNB
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`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 P81967 HPLC Method
`eport, Pages 3, Exhibit Number 1143 filed in Interferences 106,007 and 106,008 on February 16, 2015.
`
`—l—l—lLn4;
`
`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).
`
`‘4
`
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`rotein expression," Neuropathol Appl Neurobiol 2010,36: 265-74.
`
`EFS Web 2.1.1?
`
`

`

`
`
`
`
`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
`.
`.
`( Not for submissmn under 37 CFR 1.99)
`
`Application Number 15349778
`
`Filing Date
`2016-11-11
`First Named Inventor
`Peter SAZANI
`
`Art U .
`
`mt
`I 1674
`Examiner Name
`Not Yet Assigned
`
` Attorney Docket Number
`
`
`
`
`I AVN-009DVCN6 .iology, Vol. 15(5):444—451 (2008) (Exhibit Number 1057 filed in interferences 106008, 106007 on November 18,
`
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`kipping of Exon 51 During Dystrophin Pre-mRNA Splicing in Human Muscle," Human Gene Therapy, Vol. 18:798-81l
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`ytochrome P-450 3A Activity," The Journal of Pharmacology and Experimental Therapeutics, Vol. 292(3):921—928
`2000)
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`
`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
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`
`AVI BioPharma, |nc., "Exon 51 Sequence of Dystrophin," Document D19 as filed in Opposition of European Patent
`P1619249, filed June 23, 2009, 7 pages
`
`|\J|\J|\J|\J|\J
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`|\J|\J"-l0')
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`|\JCO
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`EFS Web 2.1.1?
`
`A L's PCT/NLO3I00214 (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)
`
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`
`: ELLARE, Priya et al., "A role for ubiquitin in the spliceosome assembly pathway," Nature Structural & Molecular
`
`

`

`
`
`
`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
`|1574
`
` Application Number
`
`Examiner Name
`Not Yet Assigned
`Attorney Docket Number
`
`: 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 106008106007 on November 18,
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`: 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
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`
`: ERGE, Stephen M. et al., "Pharmaceutical Salts," Journal of Pharmaceutical Sciences, Vol. 66(1):1-18 (1977)
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`
`RAASCH, Dwaine A. el 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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`iochemistry, Vol. 41(14):4503-4510 (2002) (Exhibit Number 2006 filed in interferences 106008, 106013, 106007 on
`ovember 18, 2014)
`
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`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)
`
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`00 _.
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`000003"-l
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`00(D
`
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`henotype with genetic and protein abnormalities. J Neurol 1993;240: 105—112.
`
`

`

`
`
`
`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
`|1574
`
` Application Number
`
`Examiner Name
`Not Yet Assigned
`Attorney Docket Number
`
`: ushby KM, et al., "The clinical, genetic and dystrophin characteristics of Becker muscular dystrophy," |. Natural
`istory. J Neurol 1993;240:98—104.
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`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,
`
`4:.
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`4:-4:-4:-N—‘O
`4:-4:-4:---.|o)(It4:00
`4:-4:-4:-(D03
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`|AVN-009DVCN6
`
`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
`
`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.
`
`EFS Web 2.1.17
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`

`

`
`
`
`
`Application Number 15349778
`
` Attorney Docket Number
`
`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
`.
`.
`( Not for submissmn under 37 CFR 1.99)
`
`
`Filing Date
`2016-11-11
`First Named Inventor
`Peter SAZANI
`
`Art U .
`mt
`I 1674
`
`Examiner Name
`Not Yet Assigned
`
`
`
`I AVN-OOQDVCNB If you wish to add additional non-patent literature document citation information please click the Add button
`
`EXAMINER SIGNATURE
`
`*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.
`
`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.
`4 Kind of document by the appropriate symbols as indicated on the document under WIPO Standard ST.16 if possible. 5 Applicant is to place a check mark here if
`English language translation is attached.
`
`EFS Web 2.1.17
`
`

`

`
`
`Application Number 15349778
`
`Filing Date
`2016-11-11
`First Named Inventor
`Peter SAZANI
`
`Art U .
`
`mt
`I 1674
`Examiner Name
`Not Yet Assigned
`I AVN-009DVCN6
`
`IN FORMATION DISCLOSU RE
`STATEMENT BY APPLICANT
`.
`.
`( Not for submissmn under 37 CFR 1.99)
`
`
`
` Attorney Docket Number
`
`
`
`
`
`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.
`
`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
`1.14. This collection is estimated to take 1 hour to complete, including gathering, preparing and submitting the completed
`application form to the USPTO. Time will vary depending upon the individual case. Any comments on the amount of time you
`require to complete this form andlor suggestions for reducing this burden, should be sent to the Chief Information Officer, U.S.
`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.
`
`EFS Web 2.1.17
`
`
` NamelPrint
`Signature
`2016—12—21
`
`
`
`

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