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Sig Ski Ward, Jennifer F. Bryan US009181319B2 (12) United States Patent (10) Patent No.: US 9,181,319 B2 Schrum et al. (45) Date of Patent: Nov. 10, 2015 (54) ENGINEERED NUCLEICACIDS AND 4,401,796 A 8, 1983 Itakura METHODS OF USE THEREOF 4411,657 A 10, 1983 Galindo 4.415,732 A 11/1983 Caruthers et al. 4,458,066 A 7/1984 Caruthers et al. (71) Applicant: Moderna Therapeutics, Inc., 4.474,569 A 10, 1984 Newkirk Cambridge, MA (US) 4,500,707 A 2/1985 Caruthers et al. 4,579,849 A 4, 1986 MacCoSS et al. (72) Inventors: Jason P. Schrum, Philadelphia, PA 4,588,585 A 5/1986 Market al. (US); Stephane Bancel, Cambridge, MA is, A 38. Athlet al. (US); Noubar B. Afeyan, Cambridge, 4,816,567- A 3/1989 Cabillyak ( eta. al. MA (US) 4,879,111 A 1 1/1989 Chong 4,957,735 A 9/1990 Huang (73) Assignee: Moderna Therapeutics, Inc., 4.959,314 A 9, 1990 Market al. Cambridge, MA (US) 4,973,679 A 11/1990 Caruthers et al. s 5,012,818 A 5/1991 Joishy (*) Notice: Subject to any disclaimer, the term of this 3. A &E El al. patent is extended or adjusted under 35 5,036,006 A 7, 1991 Sanford et al. U.S.C. 154(b) by 0 days. 5,047,524. A 9/1991 Andrus et al. 5,116,943 A 5/1992 Koths et al. (21) Appl. No.: 14/270,736 5,130,238 A 7, 1992 Malek et al. 5,132,418 A 7, 1992 Caruthers et al. 5,153,319 A 10, 1992 Caruthers et al. (22) Filed: May 6, 2014 5,168,038 A 12/1992 Tecott et al. 5,169,766 A 12/1992 Schuster et al. (65) Prior Publication Data 5,194,370 A 3/1993 Berninger et al. 5, 199441 A 4/1993 Hogle 5,262.530 A 11/1993 Andrus et al. Related U.S. Application Data (Continued) (62) Division of application No. 13/204,609, filed on Aug. 5, 2011, now Pat. No. 8822,663. FOREIGN PATENT DOCUMENTS (60) Provisional application No. 61/401,052, filed on Aug. CA 2376634 A1 12/2000 6, 2010. CA 2473135 C 6/2003 s CA 2795695 A1 10, 2011 EP O194809 B1 3, 1986 (51) Int. Cl. EP 0204401 A1 12, 1986 C7H 2L/04 (2006.01) EP O366400 B1 10, 1989 CI2N 15/63 (2006.01) EP O366400 A2 5, 1990 C07K I4/62 (2006.01) EP O427073 A2 5, 1991 A6 IK3I/395 (2006.01) E SER SEC A6 IK3I/7088 (2006.01) A 6LX3L/75 (2006.01) (Continued) A6 IK38/3 (2006.01) A6 IK38/9 (2006.01) OTHER PUBLICATIONS A6 IK38/28 (2006.01) AOIK 67/OO (2006.01) Attwood, T.K. The babel of bioinformatics. Science 290:471-473, (52) U.S. Cl. 2OOO.* CPC ............... C07K 14/62 (2013.01); A61 K3I/395 (Continued) (2013.01); A61K3I/7088 (2013.01); A61 K 3I/7115 (2013.01); A61K 38/13 (2013.01); A6 IK38/193 (2013.01); A61 K38/28 (2013.01) Primary Examiner Quang Nguyen (58) Field of Classification Search (74) Attorney, Agent, or Firm — DT Ward, PC; Donna T. CPC ............... C07K 14/62: A61Sig K31/7088: Ski A61 K Ward, Jennifer F. Bryan USPC ..................................... 536/23.51; 435/320.1 See application file for complete search history. (57) ABSTRACT (56) References Cited Provided are compositions and methods for delivering bio U.S. PATENT DOCUMENTS logical moieties Such as modified nucleic acids into cells to modulate protein expression. Such compositions and meth 2,008,526 A 7/1935 Wrappler et al. ods include the use of modified messenger RNAs, and are 35 52: A & 3. E. stal useful to treat or prevent diseases, disorders or conditions, or 37 66,907 A 10, 1973 MN, to improve a subjects heath or wellbeing. 3,906,092 A 9, 1975 Hilleman et al. 4,373,071 A 2f1983 Itakura 4,399.216 A 8, 1983 Axel et al. 9 Claims, 9 Drawing Sheets US 9,181,319 B2 Page 2 (56) References Cited 6,190,315 2, 2001 Kost et al. 6,210,931 4, 2001 Feldstein et al. 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