Details for Patent: 9,447,415
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| Title: | Antisense oligonucleotides for inducing exon skipping and methods of use thereof |
| Abstract: | An antisense molecule capable of binding to a selected target site to induce exon skipping in the dystrophin gene, as set forth in SEQ ID NO: 1 to 202. |
| Inventor(s): | Wilton; Stephen Donald (Applecross, AU), Fletcher; Sue (Bayswater, AU), McClorey; Graham (Bayswater, AU) |
| Assignee: | The University of Western Australia (Crawley, AU) |
| Filing Date: | Sep 17, 2015 |
| Application Number: | 14/857,561 |
| Claims: | 1.125(c), filed in Patent Interference No. 106,013, Dec. 29, 2015, pp. 1-12 (Doc 202). cited by applicant . Sarepta Therapeutics, Advisory Committee Briefing Materials: Available for Public Release, "Peripheral and Central Nervous System Drugs Advisory Committee," Eteplirsen Briefing Document, NDA 206488, pp. 1-166, dated Jan. 22, 2016. cited by applicant . Sarepta Therapeutics, Advisory Committee Briefing Materials: Available for Public Release, "Peripheral and Central Nervous System Drugs Advisory Committee," Eteplirsen Briefing Document Addendum, NDA 206488, pp. 1-9, dated Jan. 22, 2016. cited by applicant . "Open-Label, Multiple-Dose, Efficacy, Safety, and; Tolerability Study of Eteplirsen in Subjects With Duchenne; Muscular Dystrophy Who Participated in Study 4658-US-201," ClinicalTrials.gov dated Jul. 31, 2012, 3 pages. cited by applicant . "Open-Label, Multiple-Dose, Efficacy, Safety, and; Tolerability Study of Eteplirsen in Subjects With Duchenne; Muscular Dystrophy Who Participated in Study 4658-US-201," ClinicalTrials.gov dated Oct. 17, 2013, 3 pages. cited by applicant . "Open-Label, Multiple-Dose, Efficacy, Safety, and; Tolerability Study of Eteplirsen in Subjects With Duchenne; Muscular Dystrophy Who Participated in Study 4658-US-201," ClinicalTrials.gov dated Feb. 27, 2012, 3 pages. cited by applicant . Errata to the Sarepta Briefing Information for the Apr. 25, 2016 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, Eteplirsen Errata Document, NDA 206488, 5 pages. cited by applicant . FDA Briefing Information for the Apr. 25, 2016 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, Eteplirsen, NDA 206488, 115 pages. cited by applicant . Sarepta Briefing Information for the Apr. 25, 2016 Meeting of the Peripheral and Central Nervous System Drugs Advisory Committee, Eteplirsen Briefing Document, NDA 206488, 186 pages. cited by applicant . Sarepta Press Release, Sarepta Issues Statement on Advisory Committee Outcome for Use of Eteplirsen in the Treatment of Duchenne Muscular Dystrophy, Apr. 25, 2016, 2 pages. cited by applicant . University of Western Australia v. Academisch Ziekenhuis Leiden, Judgment--Motions--37 CFR .sctn. 41.127, filed in Patent Interference No. 106007, Apr. 29, 2016, pp. 1-3. cited by applicant . University of Western Australia v. Academisch Ziekenhuis Leiden, Redeclaration--37 CFR 41.203(c), filed in Patent Interference No. 106007, Apr. 29, 2016, pp. 1-2. cited by applicant . University of Western Australia v. Academisch Ziekenhuis Leiden, Decision--Motions--37 CFR .sctn. 41.125(a), filed in Patent Interference No. 106007, Apr. 29, 2016, pp. 1-53. cited by applicant . Letter to the U.S. Food and Drug Administration, (Dr. Janet Woodcock, M.D. Director, CDER), from The Congress of The United States regarding Duchenne muscular dystrophy, dated Feb. 17, 2016, 7 pages. cited by applicant . Letter to the U.S. Food and Drug Administration, (Dr. Billy Dunn, M.D. Director Division of Neurology Products, Office of Drug Evaluation 1, Center for Drug Evaluation and Research), for The Peripheral and Central Nervous System Advisory Committee Meeting (AdComm) supporting approval of eteplirsen, dated Feb. 24, 2016, 4 pages. cited by applicant . Jett Foundation Presentation by McSherry, C. "Patient and Caregiver-Reported Outcomes of Patients in Clinical Trials of Eteplirsen for Treatment of Duchenne" at Peripheral and Central Nervous System Drugs Advisory Committee, Apr. 25, 2016, 17 pages. cited by applicant . Sarepta Presentation at Peripheral and Central Nervous System Drugs Advisory Committee, Apr. 25, 2016, 133 pages. cited by applicant . U.S. Food and Drug Administration Presentation at Peripheral and Central Nervous System Drugs Advisory Committee, Apr. 25, 2016, 178 pages. cited by applicant . University of Western Australia v. Academisch Ziekenhuis Leiden, Decision--Motions--37 CFR .sctn. 41.125(a) (Substitute), filed in Patent Interference No. 106007, May 12, 2016, pp. 1-53. cited by applicant . University of Western Australia v. Academisch Ziekenhuis Leiden, Withdrawal and Reissue of Decision on Motions, filed in Patent Interference No. 106007, May 12, 2016, pp. 1-2. cited by applicant . Extended European Search Report, EP 15190341.6, dated Apr. 28, 2016, 9 pages. cited by applicant. |
Primary Examiner: Chong; Kimberly
Attorney, Agent or Firm:
