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( 12 ) United States Patent US010413581B2 (12 ) United States Patent ( 10 ) Patent No. : US 10 , 413 ,581 B2 Bafundo et al. (45 ) Date of Patent: Sep . 17 , 2019 ( 54 ) COMBINATION , COMPOSITION , AND (58 ) Field of Classification Search METHOD OF ADMINISTERING THE None COMBINATION OR COMPOSITION TO See application file for complete search history . ANIMALS (56 ) References Cited (71 ) Applicants : Phibro Animal Health Corporation , U . S . PATENT DOCUMENTS Teaneck , NJ (US ) ; Desert King 6 ,569 , 843 B1 5 /2003 Walker International LLC , San Diego , CA 2006 /0051365 A1 3 /2006 Gorenflot et al . (US ) 2008/ 0274211 AL 11/ 2008 McNeff et al. (72 ) Inventors: Kenneth W . Bafundo , Teaneck , NJ 2014 / 0037698 Al 2 / 2014 Perez (US ) ; A . Bruce Johnson , Teaneck , NJ (US ) ; David Calabotta , Teaneck , NJ FOREIGN PATENT DOCUMENTS (US ) ; Wendell Knehans , Teaneck , NJ (US ) CN 1678349 A 10 / 2005 CN 101563090 A 10 / 2009 CN 102333877 A 1 / 2012 ( 73 ) Assignees : Phibro Animal Health Corporation , EP 0 791 298 A1 8 / 1997 Teaneck , NJ (US ) ; Desert King JP 7 - 107923 4 / 1995 International LLC , San Diego , CA JP 8 - 131089 5 / 1996 H09 - 224585 9 / 1997 (US ) JP 2004 -525617 8 / 2004 ( * ) Notice : Subject to any disclaimer , the term of this WO WO 02 /052949 7 / 2002 patent is extended or adjusted under 35 WO WO 02/ 067963 9 / 2002 U . S . C . 154 (b ) by 102 days . (21 ) Appl. No. : 15 / 359 , 342 OTHER PUBLICATIONS Cheeke 2009 ( Applications of saponins as feed additives in poultry ( 22 ) Filed : Nov . 22 , 2016 production — Engormix , published Dec . 3 , 2009 ) ( Year : 2009 ). * Alfaro et al 2007 J . Appl . Poult . Res. 16 : 248 -254 . ( Year: 2007 ) . * (65 ) Prior Publication Data Shojadoost 2013 , The Journal of Applied Poultry Research , vol. 22 , Issue 2 , pp . 160 - 167 . ( Year : 2013 ). * US 2017 /0072002 A1 Mar. 16 , 2017 Abbas et al. , “ Botanicals : an alternative approach for the control of avian coccidiosis , ” World Poultry Science Journal, 68 ( 2 ) : 203 - 215 , Jun . 1 , 2012 . Related U . S . Application Data Al- Bar et al. , “ Effect of dietary Yucca shidegria extract (Deodorase ) on environmental ammonia and growth performance of chickens (63 ) Continuation - in -part of application No . and rabbits , ” Journal of Animal Science , 71( 1 ) : p . 114 , Jan . 1 , 1993 . PCT/ US2015 / 032301, filed on May 22 , 2015 . Cheeke , “ Actual and potential applications of Yucca schidigera and Quillaja saponaria saponins in human and animal nutrition ,” Pro ceedings of the American Society of Animal Science , pp . 1 - 10 , 1999 . (60 ) Provisional application No . 62 /002 , 527 , filed on May Cheeke , “ Actual and potential applications of Yucca schidigera and 23 , 2014 . Quillaja saponaria saponins in human and animal nutrition ,” Recent Advances in Animal Nutrition in Australia , vol. 13 , pp . 115 - 126 , (51 ) Int. Ci. 2001 . A61K 38 /05 ( 2006 .01 ) (Continued ) A6IK 38 / 15 ( 2006 .01 ) A23K 50 / 00 ( 2016 . 01 ) A23K 50 / 70 ( 2016 .01 ) Primary Examiner — Padmavathi Baskar A23K 50 / 75 ( 2016 .01 ) ( 74 ) Attorney , Agent, or Firm — Klarquist Sparkman , A61K 39 /012 ( 2006 .01 ) LLP A61K 36 /88 ( 2006 .01 ) A61K 36 /896 ( 2006 . 01 ) (57 ) ABSTRACT A61K 36 / 73 ( 2006 . 01 ) Disclosed herein are embodiments of a combination and /or A23K 20 / 10 ( 2016 . 01 ) composition for administration to animals . In some embodi A61K 31 /35 ( 2006 . 01 ) ments , the combination and / or composition can be admin A61K 36 / 185 ( 2006 . 01 ) istered to treat and / or prevent a disease in animals . In some A61K 39 / 00 ( 2006 .01 ) embodiments , the combination and / or composition can be (52 ) U . S . CI. administered to promote animal health . In some embodi CPC .. .. .. .. .. A61K 36 /88 (2013 . 01 ) ; A23K 20 / 10 ments , the combination comprises a composition comprising ( 2016 . 05 ) ; A23K 50 /00 (2016 . 05 ) ; A23K 50 / 70 Yucca schidigera , Quillaja saponaria , and combinations ( 2016 . 05 ) ; A23K 50 / 75 ( 2016 . 05 ) ; A61K 31 /35 thereof and a composition comprising an antimicrobial, an (2013 .01 ) ; A61K 36 / 185 (2013 .01 ) ; A61K antibiotic , an anticoccidial, a vaccine , or combinations 36 / 73 ( 2013 .01 ) ; A61K 36 /896 ( 2013 .01 ) ; thereof . The combinations or compositions disclosed herein A61K 38 / 05 (2013 . 01 ) ; A61K 38 / 15 (2013 .01 ) ; can also improve feed conversion rates in animals . A61K 39 /012 (2013 .01 ) ; AKIK 2039 /552 24 Claims, 45 Drawing Sheets ( 2013 .01 ) (23 of 45 Drawing Sheet( s ) Filed in Color ) US 10 ,413 ,581 B2 Page 2 ( 56 ) References Cited Patra et al. , “ Effects of quillaja and yucca saponins on communities and select populations of rumen bacteria and archaea , and fermen tation in vitro , ” Journal of Applied Microbiology , vol. 112 , pp . OTHER PUBLICATIONS 1329 - 1340 , Sep . 13 , 2012 . Cheeke et al. , “ Yucca , quillaja may have role in animal nutrition ," Rambozzi et al. , “ In vivo Anticoccidial Activity of Yucca schidigera Feedstuffs , 77 ( 3 ) : 8 pages , Jan . 17 , 2005 . Saponins in Naturally Infected Calves, ” Journal of Animal and Choi et al ., “ Enhancement of aerobic biodegradation in an oxygen Veterinary Advances , 10 ( 3 ) : 391 - 394 , 2011 . limiting environment using a saponin -based microbubble suspen sion ,” Environmental Pollution , vol. 157 , 2197 - 2202 , 2009 . Casillas -Hernández et al. , “ Evaluación de NUTRIFITOTM como Garcia et al ., “ Effect of Quillaja saponaria Extract on Passive promotor natural en el alimento , para la producción comercial del Immunization in Pig Model, ” Journal of Animal and Veterinary camarón blanco del Pacifico Litopenaeus vannamei ,” Revista Advances, 3 ( 8 ) : 535 - 541 , 2004 . Latinoamericano de Recursos Naturales 5 ( 2 ) : 174 - 179 , 2009 with Hassan et al. , “ Hemolytic and Antimicrobial Activities Differ Among English language abstract. Saponin - rich Extracts from Guar, Quillaja , Yucca , and Soybean , " Francis et al. , “ Quillaja saponins a natural growth promoter for Applied Biochemistry and Biotechnology , 162 ( 4 ) : 1008 - 1017 , Nov . fish , ” Animal Feed Science and Technology 121 :147 - 157 , 2005 . 15 , 2009 . Hernández - Acosta et al. , “ The effects of Yucca schidigera and Hauptli et al. “ Feeding sows in gestation and lactation with diets Quillaja saponaria on growth performance and enzymes activities containing saponins, " Ciênc . Rural, Santa Maria , v . 36 , n . 2 , p . of juvenile shrimp Litopenaeus vannamei cultured in low - salinity 610 -616 , Mar. Apr. 2006 . water, ” Latin American Journal of Aquatic Research 44 ( 1 ) : 121 - 128 , Ilsley et al ., “ Effect of dietary supplementation of sowswith quillaja Mar . 1 , 2016 . saponins during gestation on colostrum composition and perfor Office Action issued by Japan Patent Office for Japanese Application mance of piglets suckled ,” Animal Science , 80 : 179 - 184 , 2005 . No. 2017 - 514395 dated May 28 , 2019 . International Search Report and Written Opinion issued for Inter Office Action issued by Russian Patent Office for Russian Appli national Application No . PCT/ US2015 /032301 , dated Jul. 17 , 2015 cation No. 2016149801 dated May 17 , 2019 . ( 11 pages ) . Santacruz - Reyes et al ., “ Efficacy of Yucca schidigera extract from Johnston et al . , “ Evaluation of DSS4 - 0 Yucca saponin on broiler performance , " Poultry Science , 59( 7 ) : 1625 , Jan . 1 , 1980 . ammonia reduction in fresh water : Effectiveness analysis and empiri Nazeer et al. , “ Effect of Yucca Saponin on Urease Activity and cal modeling approach , " Aquaculture 287 : 106 - 111 , 2009 . Development of Ascites in Broiler Chickens , ” International Journal Bafundo et al. , “ Anticoccidial Effects ofMagni -PhiTM , a Triterpenoid of Poultry Science, 1 ( 6 ) : 174 - 178 , Jun . 2002 . Saponin , When Combined with Salinomycin or Used to Support the Turner et al. , “ Effects of a Quillaja saponaria extract on growth Effectiveness of a Coccidiosis Vaccine ,” Abstract and slide presen performance and immune function ofweanling pigs challenged with tation from the American Association of Avian Pathologists Meet Salmonella typhimurium , ” Journal of Animal Science , 80 : 1939 ing , Jul. 2015 . 1946 , 2002 Bafundo et al. , “ Performance and Anticoccidial Effects of Magni Vaclavkova et al. , “ Effect of Herbal Extract on Growth Parameters Phi in Coccidia - Vaccinated Broilers , ” International Poultry Scien of Weaned Piglets , ” Research in Pig Breeding , 2 ( 2 ) : 36 - 38 , 2008 . tific Forum , p . 10 , Jan . 2016 . Veit et al ., “ Effects of phytogenic feed additives containing Quillja Bafundo et al. , “ The effects of Nutrafito Plus and virginiamycin on saponaria on ammonia in fattening pigs ,” Proceedings of the XVth the performance and anticoccidial responses of broilers vaccinated International Congress of the International Society for Animal for coccidiosis, ” Poultry Sci . 93 : ( E - Suppl. 1 ) p . 41. Jul . 2014 . Hygiene, Vienna , Austria , Jul. 3 - 7 , 2011 , vol. 3 2011 pp . 1255 - 1257 . Espejo Marquinez “ Evaluación experimental de las saponinas del Zhao , “Mechanisms of quorum sensing and strategies for quorum quillay ( Quillaja saponaria ) como inhibidora del desarrollo de sensing disruption in aquaculture pathogens, ” Journal of Fish coccidias intestinales en pollos de engorda ,” Thesis , Universidad de Diseases, 38 ( 9 ) : 771 -786 , Sep . 15 , 2014 . Chile , availability date of Jul . 2 , 2015 . Yeo et al . , “ Effect of Feeding Diets Containing an Antibiotic , a Hassan , S . M . Antimicrobial activities of saponin - rich guar meal Probiotic, or Yucca Extract on Growth and Intestinal
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