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. Goodman, Boston, MA (US); John 3,228,838 A 1/1966 Rinfret Grant Aunins, Doylestown, PA (US); 3,608,030 A 9, 1971 Tint 4,077,227 A 3, 1978 Larson Matthew R. 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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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