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(12) United States Patent (10) Patent No.: US 9,585,921 B2 Mckenzie Et Al

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(12) United States Patent (10) Patent No.: US 9,585,921 B2 Mckenzie Et Al USOO9585921B2 (12) United States Patent (10) Patent No.: US 9,585,921 B2 McKenzie et al. (45) Date of Patent: Mar. 7, 2017 (54) COMPOSITIONS AND METHODS A61K 35/744 (2013.01); A61K 35/745 (2013.01); A61K 35/747 (2013.01); A61 K (71) Applicant: Seres Therapeutics, Inc., Cambridge, 45/06 (2013.01): CI2N 1/20 (2013.01) MA (US) (58) Field of Classification Search CPC .................................................... A61K 35/741 (72) Inventors: Gregory McKenzie, Arlington, MA See application file for complete search history. (US); Mary-Jane Lombardo McKenzie, Arlington, MA (US); David (56) References Cited N. Cook, Brooklyn, NY (US); Marin Vulic, Boston, MA (US); Geoffrey von U.S. PATENT DOCUMENTS Maltzahn, Boston, MA (US); Brian 3,009,864 A 1 1/1961 Gordon-Aldterton et al. 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(22) Filed: Oct. 15, 2015 7.628,982 B2 12/2009 Klaviniskis 7,632,520 B2 12/2009 Khandelwal (65) Prior Publication Data 7,708,988 B2 5, 2010 Farmer 7,731,976 B2 6, 2010 Cobb US 2016/O199423 A1 Jul. 14, 2016 (Continued) Related U.S. Application Data FOREIGN PATENT DOCUMENTS (60) Continuation of application No. 14/313,828, filed on Jun. 24, 2014, now Pat. No. 9,180,147, which is a EP 0033584 A3 1, 1981 division of application No. 14/197,044, filed on Mar. EP O433299 A4 4f1992 4, 2014, now Pat. No. 9,011,834, which is a (Continued) continuation of application No. PCT/US2014/014745, filed on Feb. 4, 2014. OTHER PUBLICATIONS (60) Provisional application No. 61/760,584, filed on Feb. Robinson etal (International Journal of Systmatic Bacteriology vol. 4, 2013, provisional application No. 61/760,585, filed 31, No. 3, pp. 333-338, 1981).* on Feb. 4, 2013, provisional application No. Aas, J., Gessert, C.E., and Bakken, J.S. (2003). Recurrent 61/760,574, filed on Feb. 4, 2013, provisional Clostridium difficile colitis: case series involving 18 patients treated application No. 61/760,606, filed on Feb. 4, 2013, with donor stool administered via a nasogastric tube. Clinical provisional application No. 61/926,918, filed on Jan. Infectious Diseases 36(5), 580-585. 13, 2014. Abrams, R.S., “Open-Label, Uncontrolled Trial of Bowel Steriliza tion and Repopulation with Normal Bowel Flora for Treatment of Int. C. Inflammatory Bowel Disease.” Current Therapeutic Research, Dec. (51) 1997, pp. 1001-1012, vol. 58, No. 12. CI2N 3/00 (2006.01) Achtman, M., and Wagner, M. (2008), Microbial diversity and the A6 IK 35/74 (2015.01) genetic nature of microbial species, Nat. Rev. Microbiol. 6(6), A6 IK 9/00 (2006.01) 431-440. A6 IK 45/06 (2006.01) A6 IK 35/74 (2015.01) (Continued) CI2N L/20 (2006.01) Primary Examiner — Albert Navarro A6 IK 35/742 (2015.01) (74) Attorney, Agent, or Firm — Fenwick & West LLP A6 IK 35/744 (2015.01) (57) ABSTRACT A 6LX 35/745 (2015.01) A 6LX 35/747 (2015.01) Disclosed herein are therapeutic compositions containing A6 IK 9/48 (2006.01) non-pathogenic, germination-competent bacterial spores, (52) U.S. C. for the prevention, control, and treatment of gastrointestinal CPC .......... A61K 35/741 (2013.01); A61K 9/0053 diseases, disorders and conditions and for general nutritional (2013.01); A61K 9/4816 (2013.01); A61 K health. 35/74 (2013.01); A61K 35/742 (2013.01); 24 Claims, 21 Drawing Sheets US 9,585,921 B2 Page 2 (56) References Cited WO WO 2008/076696 A2 6, 2008 WO WO 2008/083157 A2 T 2008 U.S. PATENT DOCUMENTS WO WO 2010/030997 A1 3f2010 WO WO 2010/062369 A2 6, 2010 7,763,420 B2 7/2010 Stritzker et al. WO WO 2010, 124387 A1 11, 2010 7.981,411 B2 7/2011 Nadeau et al. 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