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EXON SKIPPING OLIGOMERS FOR MUSCULAR DYSTROPHY

Docket 16/312,803, U.S. Patent Application (Dec. 21, 2018)
Art Group1635
Case TypeUtility - 514/04400A
Class514
Inventor Richard K. BESTWICK
Inventor Diane Elizabeth FRANK
Applicant Sarepta Therapeutics, Inc.
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Non-Final Rejection

Document EXON SKIPPING OLIGOMERS FOR MUSCULAR DYSTROPHY, 16/312,803, No. 1-12-US-163128030XP1 (U.S. Pat. App. Jan. 29, 2020)
Certified copies: a)I:I All b)C] Some** c)C] None of the: 1.[:] Certified copies of the priority documents have been received.
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Search information including classification, databases and other search related notes

Document EXON SKIPPING OLIGOMERS FOR MUSCULAR DYSTROPHY, 16/312,803, No. 14-1-US-163128030XP1 (U.S. Pat. App. Jan. 29, 2020)
FRAN K et al. Art Unit CPC - Searched* Symbol * See search history printout included with this form or the SEARCH NOTES box below to determine the scope of the search.
Google Scholar — "eteplirsen" 01/23/2020 Interference Search US C'aSS/CPC US Subclass/CPC Group U.S. Patent and Trademark Office Page 1 of 1 Part of Paper No.: 20200122
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List of references cited by examiner

Document EXON SKIPPING OLIGOMERS FOR MUSCULAR DYSTROPHY, 16/312,803, No. 13-1-US-163128030XP1 (U.S. Pat. App. Jan. 29, 2020)
Today: Therapeutic Strategies, volume 10, pages e149—e156.
Include as applicable: Author, Title Date, Publisher, Edition or Volume, Pertinent Pages) van Deutekom et al., Antisense oligonucleotides as personalized medicine for Duchenne muscular dystrophy, Drug Discovery *A copy of this reference is not being furnished with this Office action.
Classifications may be US or foreign.
U.S. Patent and Trademark Office PTO-892 (Rev.
01-2001) Notice of References Cited Part of Paper No. 20200122
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List of References cited by applicant and considered by examiner

Document EXON SKIPPING OLIGOMERS FOR MUSCULAR DYSTROPHY, 16/312,803, No. 22-10-US-163128030XP1 (U.S. Pat. App. Jan. 29, 2020)
Sci., 298(4):278— 281(1989) BROWN, S.C. et al., “Dystrophic phenotype induced in vitro by antibody blockade of muscle alpha-dystroglycan-laminin interaction,” Journal of Cell Science 112:209-216, 1999 CIRAK, S., et al. "Exon skipping and dystrophin restoration in patients with Duchenne muscular dystrophy after systemic phosphorodiamidate morpholino oligomertreatment: an open-label, phase 2, dose-escalation study."
DORDUNOO, S. K., et al., “Preformulation Studies on Solid Dispersions Containing Triamterene or Temazepam in Polyethylene Glycols or Gelucire 44/14 for Liquid Filling of Hard Gelatin Capsules,” Drug Development and Industrial Pharmac , 17 12 , 1685-1713,1991 DUNCKLEY, M. G., l. C. Eperon, et al. "Modulation of splicing in the DMD gene by antisense oligoribonucleotides."
270(42): 24864-24870, The American Society for Biochemistry and Molecular Biology, United States (1995) LU; Q. L. and Mann; C. J., et al., "Functional amounts of dystrophin produced by skipping the mutated exon in the mdx dystrophic mouse," Nat Med 9(8): 1009- 14, (2003).
WU, B., et al., "Targeted skipping of human dystrophin exons in transgenic mouse model systemically for antisense drug development," PloS one, 65:e19906 (2011) Examiner Date *EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609.
Hum Mol Genet 17(24): 3909-18, Oxford Academic Press, England (2008) YOKOTA T et al., "Efficacy of Systematic Morpholino Exon-Skipping in Duchenne Dystrophy Dogs," Annals of Neurology, 65(6):667-676, Vlfiley-Liss, United States (June 2009), Exhibit No. 1214 filed in lnterferences 106,007 and 106,008 on Feb. 17, 2015.
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List of References cited by applicant and considered by examiner

Document EXON SKIPPING OLIGOMERS FOR MUSCULAR DYSTROPHY, 16/312,803, No. 16-6-US-163128030XP1 (U.S. Pat. App. Jan. 29, 2020)
(Use as many sheets as necessary) Euivalent of Form PTO/SB/OSa 07-09) Comllete i Known First Named Inventor Diane Elizabeth FRANK 163 5 SHIN, Dana H.
KIM; Sung Kee et al. *EXAMINER: Initial if reference considered, whether or not citation is in conformance with MPEP 609.
Euivalent of Form PTO/SB/O8a 07-09) Comllete i Known First Named Inventor Diane Elizabeth FRANK 163 5 SHIN, Dana H. —--_ Attorney Docket Number Examiner initials" Cite
(Use as many sheets as necessary) Euuivalent of Form PTO/SB/O8a 07-09) Comllete i Known First Named Inventor Diane Elizabeth FRANK 163 5 SHIN, Dana H. —--_ Attorney Docket Number
Name of Patentee or Applicant of Cited Document Pages, > Columns, Llnes, Where Relevant e evan Pfslages pr Figures Appear EP-2799548-Al WO-9402595-Al WO-9610390-Al WO-961039l-Al WO-9610392-Al WO-96l4057-Al WO-0224906-Al
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Examiner's search strategy and results

Document EXON SKIPPING OLIGOMERS FOR MUSCULAR DYSTROPHY, 16/312,803, No. 15-1-US-163128030XP1 (U.S. Pat. App. Jan. 29, 2020)
EAST Search History EAST Search History EAST Search History (Prior Art) gRefg Hits Search Query gPluralngime gDefault gDBs Operator Stamp g2020/01/22g g15:26
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Information Disclosure Statement (IDS) Form (SB08)

Document EXON SKIPPING OLIGOMERS FOR MUSCULAR DYSTROPHY, 16/312,803, No. 1-6-US-163128030TP1 (U.S. Pat. App. Jan. 22, 2020)
(Use as many sheets as necessary) Euivalent of Form PTO/SB/OSa 07-09) Comllete i Known First Named Inventor Diane Elizabeth FRANK 163 5 SHIN, Dana H.
5 Applicant is to place a check mark here if English language Translation is attached.
(Use as many sheets as necessary) Euivalent of Form PTO/SB/O8a 07-09) Comllete i Known First Named Inventor Diane Elizabeth FRANK 163 5 SHIN, Dana H.
(Use as many sheets as necessary) Euuivalent of Form PTO/SB/O8a 07-09) Comllete i Known First Named Inventor Diane Elizabeth FRANK 163 5 SHIN, Dana H. —--_ Attorney Docket Number
Name of Patentee or Applicant of Cited Document Pages, > Columns, Llnes, Where Relevant e evan Pfslages pr Figures Appear EP-2799548-Al WO-9402595-Al WO-9610390-Al WO-961039l-Al WO-9610392-Al WO-96l4057-Al WO-0224906-Al
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