IP Library › Granted Patent US 12,558,395
Granted Patent B2
US 12,558,395 · App. 17/175,845 · Granted Feb 24, 2026

Stable dry probiotic compositions for special dietary uses

Inventors: Majid Keshtmand (Baltimore, MD); Mordechai Harel (Pikesville, MD); Trisha D. Rice (Columbia, MD)
Assignee: Advanced Bionutrition Corp.
A61K38/011A23L2/66A23L33/125A23L33/135A23L33/15A23L33/185A23L33/19A23L33/40A61K9/0056A61K9/0095A61K31/355A61K31/7016A61K31/721A61K31/733A61K31/736A61K35/745A61K35/747A61K38/018A61K47/22A23V2002/00A23V2400/113A23V2400/175A61K2035/115
View Patent ↗
Loading inventors, assignments & file history…
Monitor This Case
Get email alerts when status or documents change.
Order Certified Copies
Most orders are placed with the USPTO same day — all within 24 business hours.
Order via The Patent Place →
Pre-filled with this patent's details
Quick Facts
Patent No.
US 12,558,395
App. No.
17/175,845
Granted
Feb 24, 2026
Kind
B2
Abstract

A dry stable probiotic composition is provided. The composition comprises one or more viable probiotic microorganisms, one or more hydrolyzed proteins, one or more disaccharides, one or more oligosaccharides, and one or more polysaccharides, but not trehalose. The composition has viability of at least 1×10 10 CFU/g, and a viability loss of less than 1 log unit/g after one month at a temperature of 40° C. and a relative humidity of 33%. Also provided are methods for preparing the dry stable probiotic composition.

Claims (23)

1 . A dry composition comprising one or more viable probiotic microorganisms, one or more hydrolyzed proteins at 45-65%, one or more disaccharides at 5-30%, one or more oligosaccharides, and one or more polysaccharides, each percentage based on the total dry weight of the composition, wherein the composition does not comprise trehalose, and wherein the one or more viable probiotic microorganisms are selected from the group consisting of live probiotic bacteria, wherein the probiotic bacteria have viability of at least 1×10 10 CFU/g, and wherein the probiotic bacteria have a viability loss of less than 1 log unit/g after one month at a temperature of 40° C. and a relative humidity of 33%.

2 . The composition of claim 1 , wherein the composition provides a probiotic benefit to a host in a special dietary product.

3 . The composition of claim 2 , wherein the special dietary product is selected from the group consisting of an infant formula, a follow-on formula, processed cereal based food, canned baby food, and special food for a medical purpose.

4 . The composition of claim 2 , wherein the special dietary product is an infant formula.

5 . The composition of claim 1 , wherein the composition comprises the one or more hydrolyzed proteins at 55-60% based on the total dry weight of the composition.

6 . The composition of claim 1 , wherein the one or more hydrolyzed proteins are selected from the group consisting of milk proteins, plant proteins, and combinations thereof.

7 . The composition of claim 1 , wherein the one or more hydrolyzed proteins are selected from the group consisting of hydrolyzed casein, hydrolyzed whey protein, hydrolyzed pea protein, hydrolyzed soy protein, and combinations thereof.

8 . The composition of claim 1 , wherein the composition comprises the one or more disaccharides at 10-25% based on the total dry weight of the composition.

9 . The composition of claim 1 , wherein the one or more disaccharides are selected from the group consisting of sucrose, lactose, and combinations thereof.

10 . The composition of claim 1 , wherein the composition comprises the one or more oligosaccharides at 1-30% based on the total dry weight of the composition.

11 . The composition of claim 1 , wherein the one or more oligosaccharides are selected from the group consisting of inulin, maltodextrins, dextrans, fructo-oligosaccharides (FOS), galacto-oligosaccharides (GOS), mannan-oligosaccharides (MOS), and combinations thereof.

12 . The composition of claim 1 , wherein the composition comprises of the one or more polysaccharides at 0.1-40% based on the total dry weight of the composition.

13 . The composition of claim 1 , wherein the one or more polysaccharides are selected from the group consisting of carrageenan, guar gum, gum acacia, locust bean gum, starches, modified starches, and combinations thereof.

14 . The composition of claim 1 , further comprising one or more additional agents.

15 . The composition of claim 14 , wherein the composition comprises the one or more additional agents at 0.5-20% based on the total dry weight of the composition.

16 . The composition of claim 14 , wherein the one or more additional agents are selected from the group consisting of carboxylic acid salts, tocopherols, and combinations thereof.

17 . The composition of claim 16 , wherein the carboxylic acid salts are selected from the group consisting of ascorbic acid salts and citric acid salts.

18 . The composition of claim 14 , wherein the one or more additional agents comprise one or more tocopherols and one or more carboxylic acid salts at a weight ratio from 1:4 to 4:1.

19 . A method for preparing the composition of claim 1 , comprising:

(a) combining the one or more viable probiotic microorganisms, the one or more hydrolyzed proteins, the one or more disaccharides, the one or more oligosaccharide, and the one or more polysaccharides in an alkali aqueous solvent to form a slurry;

(b) snap-freezing the slurry in liquid nitrogen to form solid frozen particles in the form of beads, droplets or strings;

(c) primary drying step of the solid frozen particles by evaporation, under vacuum, while maintaining the temperature of the particles above their freezing temperature, whereby a primarily dried formulation is formed; and

(d) secondary drying of the primarily dried formulation at full strength vacuum and a heat source temperature of 20° C. or higher for a time sufficient to reduce the water activity of the primarily dried formulation to 0.3 Aw or lower, whereby the composition of claim 1 is prepared.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 15, 2021
From: KESHTMAND, MAJID; HAREL, MORDECHAI; RICE, TRISHA D.
To: ADVANCED BIONUTRITION CORP.
Reel/Frame 055260/0106 →
Continuity (3)
Continuation In Part 15747579
Provisional Application 62198220 · Jul 29, 2015
Related Publication 20210161990A1 · Jun 3, 2021
References Cited (400)
US 3241977A · Mitchell et al. · 1966 [cited by applicant]
US 3783098A · Calnek et al. · 1974 [cited by applicant]
US 3897307A · Porubcan et al. · 1975 [cited by applicant]
US 4337242A · Markus et al. · 1982 [cited by applicant]
US 4656767A · Tarrant · 1987 [cited by applicant]
US 5026543A · Rijke · 1991 [cited by applicant]
US 5227373A · Alexander et al. · 1993 [cited by applicant]
US 5262187A · Hahn et al. · 1993 [cited by applicant]
US 5407957A · Kyle et al. · 1995 [cited by applicant]
US 5518918A · Barclay · 1996 [cited by applicant]
US 5637494A · King · 1997 [cited by applicant]
US 5658767A · Kyle · 1997 [cited by applicant]
US 5715774A · Adey et al. · 1998 [cited by applicant]
US 5731006A · Akiyama et al. · 1998 [cited by applicant]
US 5766520A · Bronshtein · 1998 [cited by applicant]
US 5908622A · Barclay · 1999 [cited by applicant]
US 5958455A · Roser et al. · 1999 [cited by applicant]
US 5968569A · Cavadini et al. · 1999 [cited by applicant]
US 5981719A · Woiszwillo et al. · 1999 [cited by applicant]
US 6060050A · Brown et al. · 2000 [cited by applicant]
US 6187330B1 · Wang et al. · 2001 [cited by applicant]
US 6190701B1 · Roser et al. · 2001 [cited by applicant]
US 6258362B1 · Louden et al. · 2001 [cited by applicant]
US 6267958B1 · Andya et al. · 2001 [cited by applicant]
US 6290991B1 · Roser et al. · 2001 [cited by applicant]
US 6306345B1 · Bronshtein et al. · 2001 [cited by applicant]
US 6331310B1 · Roser et al. · 2001 [cited by applicant]
US 6338856B1 · Allen et al. · 2002 [cited by applicant]
US 6338866B1 · Criggall et al. · 2002 [cited by applicant]
US 6451567B1 · Barclay · 2002 [cited by applicant]
US 6468782B1 · Tunnacliffe et al. · 2002 [cited by applicant]
US 6503411B1 · Franks et al. · 2003 [cited by applicant]
US 6509146B1 · Bronshtein · 2003 [cited by applicant]
US 6509178B1 · Tanaka et al. · 2003 [cited by applicant]
US 6534087B2 · Busson et al. · 2003 [cited by applicant]
US 6537666B1 · Bronshtein · 2003 [cited by applicant]
US 6565871B2 · Roser et al. · 2003 [cited by applicant]
US 6582941B1 · Yokochi et al. · 2003 [cited by applicant]
US 6586006B2 · Roser et al. · 2003 [cited by applicant]
US 6589560B2 · Foster et al. · 2003 [cited by applicant]
US 6592863B2 · Fuchs et al. · 2003 [cited by applicant]
US 6664099B1 · Worrall · 2003 [cited by applicant]
US 6716460B2 · Abril · 2004 [cited by applicant]
US 6726934B1 · Prokop · 2004 [cited by applicant]
US 6733759B2 · Ivey et al. · 2004 [cited by applicant]
US 6790453B2 · Porzio et al. · 2004 [cited by applicant]
US 6797266B2 · Naidu · 2004 [cited by applicant]
US 6811792B2 · Roser et al. · 2004 [cited by applicant]
US 6841181B2 · Jager et al. · 2005 [cited by applicant]
US 6872357B1 · Bronshtein et al. · 2005 [cited by applicant]
US 6884866B2 · Bronshtein et al. · 2005 [cited by applicant]
US 6900173B2 · Martin et al. · 2005 [cited by applicant]
US 6919172B2 · DePablo et al. · 2005 [cited by applicant]
US 6964771B1 · Roser et al. · 2005 [cited by applicant]
US 7005280B2 · Barclay · 2006 [cited by applicant]
US 7052719B2 · Bernstein et al. · 2006 [cited by applicant]
US 7056495B2 · Roser et al. · 2006 [cited by applicant]
US 7122370B2 · Porubcan · 2006 [cited by applicant]
US 7153472B1 · Bronshtein · 2006 [cited by applicant]
US 7258873B2 · Truong-Le et al. · 2007 [cited by applicant]
US 7282194B2 · Sung et al. · 2007 [cited by applicant]
US 7381425B1 · Truong-Le · 2008 [cited by applicant]
US 7396548B2 · Kyle · 2008 [cited by applicant]
US 7744925B2 · Roser et al. · 2010 [cited by applicant]
US 7842310B2 · Hwang et al. · 2010 [cited by applicant]
US 7927858B2 · Mayeresse · 2011 [cited by applicant]
US 7939105B2 · Parikh et al. · 2011 [cited by applicant]
US 7998502B2 · Harel · 2011 [cited by applicant]
US 8097245B2 · Harel et al. · 2012 [cited by applicant]
US 8377496B2 · Clinger et al. · 2013 [cited by applicant]
US 8460726B2 · Harel et al. · 2013 [cited by applicant]
US 8834951B2 · Harel et al. · 2014 [cited by applicant]
US 8871266B2 · Crittenden et al. · 2014 [cited by applicant]
US 8968721B2 · Harel · 2015 [cited by applicant]
US 9044497B2 · Harel et al. · 2015 [cited by applicant]
US 9072310B2 · Harel et al. · 2015 [cited by applicant]
US 10370636B2 · Van Hee · 2019 [cited by applicant]
US 20010012610A1 · Bronshtein et al. · 2001 [cited by applicant]
US 20010016220A1 · Jager et al. · 2001 [cited by applicant]
US 20020192202A1 · Naidu · 2002 [cited by applicant]
US 20030017192A1 · Kanafani et al. · 2003 [cited by applicant]
US 20030022333A1 · Bronshtein · 2003 [cited by applicant]
US 20030147898A1 · Nest et al. · 2003 [cited by applicant]
US 20030165472A1 · McGrath et al. · 2003 [cited by applicant]
US 20030190332A1 · Gilad et al. · 2003 [cited by applicant]
US 20040038825A1 · Leland et al. · 2004 [cited by applicant]
US 20040047881A1 · Kyle · 2004 [cited by applicant]
US 20040062758A1 · Mayra-Makinen et al. · 2004 [cited by applicant]
US 20040081638A1 · Kyle · 2004 [cited by applicant]
US 20040081699A1 · Rademacher et al. · 2004 [cited by applicant]
US 20040175389A1 · Porubcan · 2004 [cited by applicant]
US 20040177392A1 · Barratt et al. · 2004 [cited by applicant]
US 20040219206A1 · Roser et al. · 2004 [cited by applicant]
US 20040241313A1 · Nana et al. · 2004 [cited by applicant]
US 20050019417A1 · Ko et al. · 2005 [cited by applicant]
US 20050032192A1 · Vesey et al. · 2005 [cited by applicant]
US 20050079244A1 · Giffard et al. · 2005 [cited by applicant]
US 20050100559A1 · Myatt et al. · 2005 [cited by applicant]
US 20050123599A1 · Ott et al. · 2005 [cited by applicant]
US 20050153018A1 · Ubbink et al. · 2005 [cited by applicant]
US 20050241011A1 · Allnut et al. · 2005 [cited by applicant]
US 20050266069A1 · Simmons et al. · 2005 [cited by applicant]
US 20060008861A1 · Allnut et al. · 2006 [cited by applicant]
US 20060024404A1 · Kyle · 2006 [cited by applicant]
US 20060051408A1 · Duena et al. · 2006 [cited by applicant]
US 20060120999A1 · Dhar et al. · 2006 [cited by applicant]
US 20060121468A1 · Allnut et al. · 2006 [cited by applicant]
US 20060127453A1 · Harel · 2006 [cited by applicant]
US 20060130162A1 · Kyle et al. · 2006 [cited by applicant]
US 20060147500A1 · Klingeberg et al. · 2006 [cited by applicant]
US 20060154067A1 · Cooper et al. · 2006 [cited by applicant]
US 20060222694A1 · Oh et al. · 2006 [cited by applicant]
US 20060258623A1 · Harel et al. · 2006 [cited by applicant]
US 20060265766A1 · Kyle et al. · 2006 [cited by applicant]
US 20070020289A1 · Mattern et al. · 2007 [cited by applicant]
US 20070031534A1 · Tsujimoto et al. · 2007 [cited by applicant]
US 20070082008A1 · Harel et al. · 2007 [cited by applicant]
US 20070122397A1 · Sanguansri et al. · 2007 [cited by applicant]
US 20070196508A1 · Heuer et al. · 2007 [cited by applicant]
US 20070207165A1 · Thiry et al. · 2007 [cited by applicant]
US 20070211397A1 · Sokolow et al. · 2007 [cited by applicant]
US 20070292952A1 · Dhar et al. · 2007 [cited by applicant]
US 20080044081A1 · Lieb · 2008 [cited by applicant]
US 20080044481A1 · Harel · 2008 [cited by applicant]
US 20080050497A1 · Mai et al. · 2008 [cited by applicant]
US 20080102132A2 · Giner et al. · 2008 [cited by applicant]
US 20080107634A1 · Mogna et al. · 2008 [cited by applicant]
US 20080112972A1 · Truong-Le · 2008 [cited by applicant]
US 20080131514A1 · Truong-Le et al. · 2008 [cited by applicant]
US 20080193546A1 · Roser et al. · 2008 [cited by applicant]
US 20080194504A1 · Kyle et al. · 2008 [cited by applicant]
US 20080221231A1 · Cooper et al. · 2008 [cited by applicant]
US 20080229609A1 · Bronshtein · 2008 [cited by applicant]
US 20080241244A1 · Truong-Le · 2008 [cited by applicant]
US 20080261916A1 · Jaszberenyi et al. · 2008 [cited by applicant]
US 20090155351A1 · Hejl et al. · 2009 [cited by applicant]
US 20090162518A1 · Clinger et al. · 2009 [cited by applicant]
US 20090162521A1 · Clinger et al. · 2009 [cited by applicant]
US 20090181363A1 · Dhar · 2009 [cited by applicant]
US 20090203592A1 · Beermann et al. · 2009 [cited by applicant]
US 20090208585A1 · Roser et al. · 2009 [cited by applicant]
US 20090232894A1 · Chouvenc et al. · 2009 [cited by applicant]
US 20090238890A1 · Piechocki et al. · 2009 [cited by applicant]
US 20090246184A1 · Harel et al. · 2009 [cited by applicant]
US 20090324636A1 · Piechocki et al. · 2009 [cited by applicant]
US 20100015177A1 · Drew et al. · 2010 [cited by applicant]
US 20100047393A1 · Glas et al. · 2010 [cited by applicant]
US 20100074994A1 · Harel et al. · 2010 [cited by applicant]
US 20100086638A1 · Kyle et al. · 2010 [cited by applicant]
US 20100092521A1 · Dhar et al. · 2010 [cited by applicant]
US 20100120014A1 · Bronshtein · 2010 [cited by applicant]
US 20100120676A1 · Boehm et al. · 2010 [cited by applicant]
US 20100189767A1 · Shimoni et al. · 2010 [cited by applicant]
US 20100242301A1 · Rampersad et al. · 2010 [cited by applicant]
US 20100297231A1 · Vehring et al. · 2010 [cited by applicant]
US 20110070334A1 · Rangavajla · 2011 [cited by applicant]
US 20110120489A1 · Pye et al. · 2011 [cited by applicant]
US 20110223282A1 · Degonda et al. · 2011 [cited by applicant]
US 20120009248A1 · Truong-Le et al. · 2012 [cited by applicant]
US 20120039956A1 · Harel et al. · 2012 [cited by applicant]
US 20120040010A1 · Harel et al. · 2012 [cited by applicant]
US 20120114621A1 · Harel · 2012 [cited by applicant]
US 20120135017A1 · Harel et al. · 2012 [cited by applicant]
US 20120172319A1 · Chow · 2012 [cited by examiner]
US 20120288483A1 · Harel · 2012 [cited by applicant]
US 20120322663A1 · Harel et al. · 2012 [cited by applicant]
US 20130287896A1 · Harel et al. · 2013 [cited by applicant]
US 20130296165A1 · Harel et al. · 2013 [cited by applicant]
US 20130344045A1 · Faure et al. · 2013 [cited by applicant]
US 20140093613A1 · Cevallos et al. · 2014 [cited by applicant]
US 20140255366A1 · Yde · 2014 [cited by applicant]
US 20160360777A1 · Penhasi · 2016 [cited by applicant]
CA 2497264A1 · 2004 [cited by applicant]
CA 2420095A1 · 2004 [cited by applicant]
CA 2807997A1 · 2012 [cited by applicant]
CL 09312008A1 · 2008 [cited by applicant]
CN 1223865A · 1999 [cited by applicant]
CN 101287449A · 2008 [cited by applicant]
CN 101951789A · 2011 [cited by applicant]
CN 102186360A · 2011 [cited by applicant]
CN 103249830A · 2013 [cited by applicant]
CN 103347395A · 2013 [cited by applicant]
EP 0028563A1 · 1980 [cited by applicant]
EP 0259739A1 · 1987 [cited by applicant]
EP 0471904A1 · 1990 [cited by applicant]
EP 1110462A2 · 2001 [cited by applicant]
EP 1344458A1 · 2003 [cited by applicant]
EP 3328215B1 · 2018 [cited by applicant]
GB 1232057A · 1971 [cited by applicant]
GB 2389787A · 2003 [cited by applicant]
JP 57114527A · 1982 [cited by applicant]
JP 05246856A · 1993 [cited by applicant]
JP 0622746A · 1994 [cited by applicant]
JP 11506467A · 1999 [cited by applicant]
JP 11513700A · 1999 [cited by applicant]
JP 2001505431A · 2001 [cited by applicant]
JP 2002512970A · 2002 [cited by applicant]
JP 2002530321A · 2002 [cited by applicant]
JP 2004506437A · 2004 [cited by applicant]
JP 2004525106A · 2004 [cited by applicant]
JP 2004528288A · 2004 [cited by applicant]
JP 2005501268A · 2005 [cited by applicant]
JP 2005519600A · 2005 [cited by applicant]
JP 2005270100A · 2005 [cited by applicant]
JP 2005534741A · 2005 [cited by applicant]
JP 2007519796A · 2007 [cited by applicant]
JP 2007522085A · 2007 [cited by applicant]
JP 2009522280A · 2009 [cited by applicant]
JP 2010512755A · 2010 [cited by applicant]
JP 2010227125A · 2010 [cited by applicant]
JP 2013535222A · 2013 [cited by applicant]
JP 2015517985A · 2015 [cited by applicant]
KR 20050106559A · 2005 [cited by applicant]
KR 20050105669A · 2006 [cited by applicant]
RU 2277905C2 · 2006 [cited by applicant]
RU 2374859C2 · 2009 [cited by applicant]
RU 2410084C1 · 2011 [cited by applicant]
WO 9527721A1 · 1995 [cited by applicant]
WO 9640077A2 · 1996 [cited by applicant]
WO 9824327A1 · 1998 [cited by applicant]
WO 9824882A1 · 1998 [cited by applicant]
WO 0032064A1 · 2000 [cited by applicant]
WO 0112779A1 · 2001 [cited by applicant]
WO 0136590A1 · 2001 [cited by applicant]
WO 0215720A2 · 2002 [cited by applicant]
WO 02058735A1 · 2002 [cited by applicant]
WO 02061111A2 · 2002 [cited by applicant]
WO 02076391A2 · 2002 [cited by applicant]
WO 03086454A1 · 2003 [cited by applicant]
WO 03087327A1 · 2003 [cited by applicant]
WO 03088755A1 · 2003 [cited by applicant]
WO 03089579A2 · 2003 [cited by applicant]
WO 03103692A1 · 2003 [cited by applicant]
WO 2004022728A1 · 2004 [cited by applicant]
WO 2004024177A1 · 2004 [cited by applicant]
WO 2004039417A2 · 2004 [cited by applicant]
WO 2004043139A2 · 2004 [cited by applicant]
WO 2004080196A2 · 2004 [cited by applicant]
WO 2004091307A2 · 2004 [cited by applicant]
WO 2004112767A1 · 2004 [cited by applicant]
WO 2004112776A2 · 2004 [cited by applicant]
WO 2005030229A1 · 2005 [cited by applicant]
WO 2005060937A1 · 2005 [cited by applicant]
WO 2005084646A1 · 2005 [cited by applicant]
WO 2005105978A1 · 2005 [cited by applicant]
WO 2005115341A2 · 2005 [cited by applicant]
WO 2005117962A1 · 2005 [cited by applicant]
WO 2006085082A1 · 2006 [cited by applicant]
WO 2006122299A2 · 2006 [cited by applicant]
WO 2007035455A2 · 2007 [cited by applicant]
WO 2007038926A1 · 2007 [cited by applicant]
WO 2007067207A1 · 2007 [cited by applicant]
WO 2007075988A2 · 2007 [cited by applicant]
WO 2007079147A2 · 2007 [cited by applicant]
WO 2007084059A1 · 2007 [cited by applicant]
WO 2007084500A2 · 2007 [cited by applicant]
WO 2007117511A2 · 2007 [cited by applicant]
WO 2007136553A2 · 2007 [cited by applicant]
WO 2008016214A1 · 2008 [cited by applicant]
WO 2008056983A1 · 2008 [cited by applicant]
WO 2008076975A1 · 2008 [cited by applicant]
WO 2009002481A1 · 2008 [cited by applicant]
WO 2009020455A1 · 2009 [cited by applicant]
WO 2009140327A2 · 2009 [cited by applicant]
WO 2010002418A2 · 2010 [cited by applicant]
WO 2010046321A1 · 2010 [cited by applicant]
WO 2010111347A2 · 2010 [cited by applicant]
WO 2010118188A2 · 2010 [cited by applicant]
WO 2010118205A3 · 2010 [cited by applicant]
WO 2010125084A1 · 2010 [cited by applicant]
WO 2010135495A1 · 2010 [cited by applicant]
WO 2010138522A2 · 2010 [cited by applicant]
WO 2011094469A2 · 2011 [cited by applicant]
WO 2012021783A2 · 2012 [cited by applicant]
WO 2013142792A1 · 2013 [cited by applicant]
Abdelwahed et al., Advanced Drug Delivery Reviews. 58:1688-1713 (2006). [cited by applicant]
Anal et al., Trends in Food Science and Technology, 18(5):240-51 (2007). [cited by applicant]
Anderson et al., Am. J. Clin, Nutr . . . 70:525-35 (1999). [cited by applicant]
Annear, J. Gen. Microbial., 27:341-3 (1962). [cited by applicant]
Aral et al., International Journal of Pharmaceutics 168:9-15 (1998). [cited by applicant]
Argentinian Office Action for Argentinian Application No. 20160102257, dated Sep. 2, 2020, with partial translation, 6 pages. [cited by applicant]
Australian Examination Report for Australian Application No. 2016297986, dated Sep. 30, 2019, 3 pages. [cited by applicant]
Australian Examination Report for Australian Application No. 2013234931, dated Dec. 7, 2016, 4 pages. [cited by applicant]
Australian Examination Report for Australian Application No. 2013234931, dated Mar. 21, 2017, 3 pages. [cited by applicant]
Australian Examination Report for Australian Application No. 2010254235, dated Jan. 23, 2015, 3 pages. [cited by applicant]
Bakker-Zierikzee et al., British Journal of Nutrition, 94(5):783-90 (2005). [cited by applicant]
Bazan et al., Upsala J. Med. Sci., Suppl., 48:97-107 (1990). [cited by applicant]
Bazan et al., J. Ocul. Pharmacol., 10:591-604 (1994). [cited by applicant]
Behrens et al., J. Food Sci., 3:259-72 (1996). [cited by applicant]
Benedict et al., Appl. Microbial., 6(6):401-7 (1958). [cited by applicant]
Bergogne et al., Molecular Crystals and Liquid Crystals, 354: 79-89 (2000). [cited by applicant]
Bodmeier et al., Drug Development and Industrial Pharmacy, 15(9):1475-94 (1989). [cited by applicant]
Boswell et al., SCO Production by Fermentive Microalgae. In: Kyle DJ, Ratledge C (eds) Industrial Applications of Single Cell Oils. American Oil Chemists Society, Champaign, IL., pp. 274-286 (1992). [cited by applicant]
Bradford, Analytical Biochemistry 72:248-54 (1976). [cited by applicant]
Calvo et al., Journal of Applied Polymer Science, 63:125-32 (1997). [cited by applicant]
Canadian Office Action for Canadian Application No. 2,673,120, dated Apr. 6, 2011, 3 pages. [cited by applicant]
Canadian Office Action for Canadian Application No. 2,756,883, dated Dec. 8, 2015, 4 pages. [cited by applicant]
Canadian Office Action for Canadian Application No. 2,763,074, dated Mar. 10, 2016, 8 pages. [cited by applicant]
Canadian Office Action for Canadian Application No. 2,785,815, dated Oct. 10, 2014, 2 pages. [cited by applicant]
Canadian Office Action for Canadian Application No. 2,765,815, dated Oct. 14, 2016, 3 pages. [cited by applicant]
Canadian Office Action for Canadian Application No. 2,763,074, dated Oct. 22, 2018, 4 pages. [cited by applicant]
Canadian Office Action for Canadian Application No. 2,785,815, dated Sep. 8, 2015, 4 pages. [cited by applicant]
Canadian Office Action for Canadian Application No. 2,756,883, dated Sep. 9, 2016, 4 pages. [cited by applicant]
Capela et al., Food Research International 39:203-11 (2006). [cited by applicant]
Carlsen et al., Cryobiology, 2009, 6 pages. [cited by applicant]
Chen et al., Cryobiology, 43:168-81 (2001). [cited by applicant]
Chen et al., China Tropical Medicine, 7(4):654-55 (2007) (with partial English translation). [cited by applicant]
Chilean Examination Report for Application No. 759-09, dated Mar. 27, 2009, 10 pages. [cited by applicant]
Chilean Examination Report for Application No. 2506-14, dated Jan. 24, 2017, 14 pages. [cited by applicant]
Chilean Examination Report for Application No. 201402506, dated Oct. 16, 2017, 8 pages. [cited by applicant]
Chinese Notification of Reexamination of Chinese Application No. 201060029392.4, dated Jul. 13, 2016, 10 pages. [cited by applicant]
Chinese Reexamination Report for Chinese Application No. 201080029392.4, dated Dec. 23, 2015, 7 pages. [cited by applicant]
Chinese Search Report for Chinese Application No. 2013800115928.0 dated Feb. 23, 2016, 4 pages. [cited by applicant]
Chinese Search Report for Chinese Application No. 201180039219.7 dated May 26, 2014, 7 pages. [cited by applicant]
Chinese Office Action for Chinese Application No. 201410326898.1, dated Apr. 1, 2016, 16 pages. [cited by applicant]
Chinese Office Action for Chinese Application No. 201380015928.0, dated Apr. 5, 2017, 10 pages. [cited by applicant]
Chinese Office Action for Chinese Application No. 201380015928.0, dated Feb. 26. 2016, 8 pages. [cited by applicant]
Chinese Office Action for Chinese Application No. 201180007562.3, dated Mar. 2, 2015, 9 pages. [cited by applicant]
Chinese Office Action for Chinese Application No. 201380015928.0, dated Nov. 3, 2017, 10 pages. [cited by applicant]
Crawford et al., Eur. J. Pediatr., 157(Suppl 1):S23-7 (1998). [cited by applicant]
Crowe et al., Cryobiology, 20:346-56 (1983). [cited by applicant]
Crowe et al., Adv. Space Res., 12(4):239-47 (1992). [cited by applicant]
Crowe et al., Annu. Rev. Physiol., 60:73-103 (1998). [cited by applicant]
Dang et al., Adv. Drug Deliv. Rev., 58(4):487-99 (2006). [cited by applicant]
Chinese Decision on Rejection for Chinese Application No. 201680051904.4, issued May 20, 2021, with partial English translation, 15 pages. [cited by applicant]
Ünlü, C., et al., “Use of lactobacilli and estriol combination in a treatment of disturbed vaginal ecosystem: a review,” 2011, 12: 239-46, J Turkish-German Gynecol Assoc. [cited by applicant]
Argentina Substantive Examination Report for Argentina Application No. P130100304, dated Jun. 2, 2021, 10 pages. [cited by applicant]
Melczer et al., “Experience with Local Ecotherapy in the Treatment of Bacterial Vaginosis in Pregnant and Non-Pregnant Women”, Journal of Hungarian Association of Obstetrics and Gynecology [Magyar Nöorv Labj], 2003, vol… [cited by applicant]
Davis, S., Vaccine, 24(2):7-10 (2006). [cited by applicant]
De Giulio et al., World Journal of Microbiology and Biotechnology, 21 (5):739-46 (2005). [cited by applicant]
Desai et al., Pharmaceutical Research, 1(12):1838-45 (1996). [cited by applicant]
European Communication for European Application No. 07865743, dated Mar. 2, 2017, 4 pages. [cited by applicant]
European Communication for European Application No. 11817090, dated Jul. 15, 2016, 5 pages. [cited by applicant]
Extended European Search Report for European Application No. 13764136, dated Apr. 9, 2015, 8 pages. [cited by applicant]
Extended European Search Report for European Application No. 11817090, dated Jun. 16, 2014, 12 pages. [cited by applicant]
European Office Action for European Application No. 10756894, dated Jun. 22, 2016, 5 pages. [cited by applicant]
European Office Action for European Application No. 11817090, dated Nov. 6, 2015, 7 pages. [cited by applicant]
European Office Action for European Application No. 10781100, dated Oct. 17, 2014, 7 pages. [cited by applicant]
Esquisabel et al., J. Microencapsulation, 24:627-38 (1997). [cited by applicant]
Favaro-Trindade et al., J. Microencapsulation, vol. 19, pp. 485-494 (2002). [cited by applicant]
First Office Action with a Search Report for Chinese Application No. 201180007562.3, issued by the State Intellectual Property Office of the People's Republic of China on May 22, 2013. [cited by applicant]
First Examination Report for Indian Patent Application No. 7257/DELNP/2012, mailed Jan. 11, 2018 (with English Translation). [cited by applicant]
Final Office Action for U.S. Appl. No. 13/260,661, dated Jun. 1, 2016, 47 pages. [cited by applicant]
Final Office Action for U.S. Appl. No. 13/321,706, dated Aug. 5, 2016, 30 pages. [cited by applicant]
Final Office Action for U.S. Appl. No. 13/321,708, dated Jul. 5, 2018, 20 pages. [cited by applicant]
Final Office Action for U.S. Appl. No. 15/687,730, dated Jun. 24, 2019, 21 pages. [cited by applicant]
Final Office Action for U.S. Appl. No. 13/321,706, dated Jan. 14, 2015, 40 pages. [cited by applicant]
Final Office Action for U.S. Appl. No. 13/208,459, dated Oct. 27, 2014, 22 pages. [cited by applicant]
Grinstead et al., Animal Feed Sci. Technol., 83:237-47 (2000). [cited by applicant]
Harel et al., XVIIth International Conference on Bioencapsulation, Sep. 24-26, 2009, 2 pages. [cited by applicant]
He et al., J. Animal Physiol. Animal Nutri., 86:97-104 (2002). [cited by applicant]
Higl et al., Biotechnol. Prog. 2007, vol. 23, pp. 794-800. [cited by applicant]
Hincha et al., European Biophysics Journal, 37:503-8 (2008). [cited by applicant]
Huang et al., Journal of Microencapsulation, 20(2):247-60 (2003). [cited by applicant]
Hughes et al., Obstet. Gynecol., 75:244-8 (1990). [cited by applicant]
Iaconelli et al., Journal of Biotechnology, 2015, vol. 214, pp. 17-26. [cited by applicant]
Ikemoto et al., Neurochem. Res., 22:671-8 (1997). [cited by applicant]
Indian Examination Report for Indian Application No. 824/DELNP/2013, dated Oct. 18, 2017. 7 pages. [cited by applicant]
Indian Office Action for Indian Application No. 9996/DELNP/2011, mailed Sep. 12, 2017, 8 pages. [cited by applicant]
Indonesian Examination Report for Indonesian Application No. W00 201104583, dated Jun. 27, 2016, 4 pages. [cited by applicant]
Indonesian Examination Report for Indonesian Application No. W00 2013 00512, dated Jun. 30, 2016, 4 pages. [cited by applicant]
Indonesian Examination Report for Indonesian Application No. W00 201202694, dated Nov. 27, 2017, 3 pages. [cited by applicant]
International Preliminary Report on Patentability for PCT International Application No. PCT/US2011/022821, dated Jul. 31, 2012, 5 pages. [cited by applicant]
International Preliminary Report on Patentability and Written Opinion for PCT International Application No. PCT/US2013/033505 issued Sep. 23, 2014, 15 pages. [cited by applicant]
International Preliminary Report on Patentability and Written Opinion for International Application No. PCT/US2016/041428, issued Jan. 30, 2018, 10 pages. [cited by applicant]
International Search Report for Application No. PCT/US2011/022821, mailed Oct. 25, 2011, 4 pages. [cited by applicant]
International Search Report for Application No. PCT/US2010/028767, mailed Dec. 23, 2010, 4 pages. [cited by applicant]
International Search Report for Application No. PCT/US2010/036098, mailed Feb. 14, 2011, 3 pages. [cited by applicant]
International Search Report for Application No. PCT/US2016/041428, mailed Oct. 21, 2016, 12 pages. [cited by applicant]
International Search Report for Application No. PCT/US2006/49434, mailed Sep. 26, 2007, 2 pages. [cited by applicant]
International Search Report for Application No. PCT/US2007/087771, mailed May 16, 2008, 2 pages. [cited by applicant]
Isolauri et al., Am. J. Clin. Nutr., 73:444S-450S (2001). [cited by applicant]
Japanese Notice of Reasons for Rejection for Japanese Application No. 2018-504716, dated Dec. 8, 2020, with translation, 6 pages. [cited by applicant]
Japanese Notice of Reasons for Rejection for Japanese Application No. 2018-504716, dated Jan. 28, 2020, with translation, 10 pages. [cited by applicant]
Japanese Office Action for Japanese Application No. 2012-513183, dated Aug. 1, 2014, 9 pages. [cited by applicant]
Japanese Office Action for Japanese Application No. 2013-524242, dated Jan. 21, 2014, 6 pages. [cited by applicant]
Japanese Office Action for Japanese Application No. 2008-548729, mailed Jul. 23, 2012, 5 pages. [cited by applicant]
Japanese Office Action for Japanese Application No. 2009-541634 mailed Jun. 25, 2012, 7 pages. [cited by applicant]
Panos et al., Current Drug Discovery Technologies, 5:333-41 (2008). [cited by applicant]
Perdigon et al., Curr. Issues Intest. Microbial., 2:27-42 (2001). [cited by applicant]
Perry, S., Molecular Biotechnology, 9(1):59-64 (1998). [cited by applicant]
Philippine Substantive Examination Report for Philippine Application No. 1-2014-502092, dated Feb. 6, 2018, 7 pages. [cited by applicant]
Philippine Substantive Examination Report for Philippine Application No. 1-2011-502445, dated Jan. 14, 2016, 4 pages. [cited by applicant]
Philippine Substantive Examination Report for Philippine Application No. 1-2012-501410. dated Apr. 15, 2016, 2 pages. [cited by applicant]
Philippine Substantive Examination Report for Philippine Application No. 1-2014-502092, dated Jun. 14, 2019, 4 pages. [cited by applicant]
Qiu et al., Comparative Biochemistry & Physiology, Part B, 125:411-9 (2000). [cited by applicant]
Rege et al., International Journal of Pharmaceutics 252:41-51 (2003). [cited by applicant]
Russian Office Action for Russian Application No. 2011151788/10 (077759) mailed Aug. 6, 2014, 8 pages. [cited by applicant]
Russian Office Action for Russian Application No. 2011151788/10 (077759) mailed Dec. 18, 2014, 10 pages. [cited by applicant]
Russian Office Action for Russian Application No. 2014136089/15 (058394) mailed Feb. 14, 2018, 13 pages. [cited by applicant]
Russian Office Action for Russian Application No. 2013110833/13 (016008) mailed Jul. 21, 2015, 6 pages. [cited by applicant]
Russian Office Action for Russian Application No. 2011151788/10 (077759) mailed Mar. 21, 2014, 11 pages. [cited by applicant]
Russian Office Action for Russian Application No. 2014136089/15 (058394) mailed May 17, 2017, 13 pages. [cited by applicant]
Sanchez et al., Intl. J. Pharm., 185:255-66 (1999). [cited by applicant]
Santivarangkna et al., Journal of Food Science, 76(8):R152-R-156 (2011 ). [cited by applicant]
Schwab et al., Cryobiology, 55:108-14 (2007). [cited by applicant]
Selmer-Olsen et al., Journal of Industrial Microbiology & Biotechnology, 23:79-85 (1999). [cited by applicant]
Shah, Journal Dairy Sci., 83:894-907 (2000). [cited by applicant]
Shin et al., Journal of Food Science, 65(5):884-7 (2000). [cited by applicant]
Shiraishi et al., Journal of Controlled Release, 25:217-25 (1993). [cited by applicant]