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(11) Application No. AU 2017249661 B2 AUSTRALIAN PATENT OFFICE

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(11) Application No. AU 2017249661 B2 AUSTRALIAN PATENT OFFICE (12) STANDARD PATENT (11) Application No. AU 2017249661 B2 (19) AUSTRALIAN PATENT OFFICE (54) Title Bifidobacteria for reducing food, energy and/or fat intake (51) International Patent Classification(s) A61K 35/745 (2015.01) A61P7/00 (2006.01) A23L 33/135 (2016.01) (21) Application No: 2017249661 (22) Date of Filing: 2017.04.06 (87) WIPO No: WO17/178316 (30) Priority Data (31) Number (32) Date (33) Country 16165379.5 2016.04.14 EP (43) Publication Date: 2017.10.19 (44) Accepted Journal Date: 2020.03.19 (71) Applicant(s) Dupont Nutrition Biosciences ApS (72) Inventor(s) Stenman, Lotta;Lahtinen, Sampo (74) Agent / Attorney Houlihan2 Pty Ltd, Level 1, 70 Doncaster Road, BALWYN NORTH, VIC, 3104, AU (56) Related Art WO 2015007941 A1 WO 2007043933 A1 WO 2010146568 A2 A. IBARRA ET AL, "Effects of polydextrose on different levels of energy intake. A systematic review and meta-analysis", APPETITE, (2015-04-01), vol. 87, pages 30-37 WO 2016020495 A1 L.K. STENMAN et al., "Potential probiotic Bifidobacterium animalis ssp. lactis 420 prevents weight gain and glucose intolerance in diet-induced obese mice", BENEFICIAL MICROBES, (2014-12-01), vol. 5, no. 4, pages 437 - 445 WO 2016020488 A1 (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization lllllllllllllllllllllllllllllllllllllllllll^ International Bureau (10) International Publication Number (43) International Publication Date WO 2017/178316 Al 19 October 2017 (19.10.2017) WIPO I PCT (51) International Patent Classification: MD, ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, A61K35/745 (2015.01) A61P 7/00 (2006.01) NI, NO, NZ, OM, PA, PE, PG, PH, PL, PT, QA, RO, RS, A23L 33/135 (2016.01) RU, RW, SA, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, (21) International Application Number: ZA, ZM, ZW. PCT/EP2017/05 8206 (84) Designated States (unless otherwise indicated, for every (22) International Filing Date: kind of regional protection available): ARIPO (BW, GH, 6 April 2017 (06.04.2017) GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, ST, SZ, (25) Filing Language: English TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, (26) Publication Language: English DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, IT, LT, LU, (30) Priority Data: LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, 16165379.5 14 April 2016 (14.04.2016) EP SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, GA, GN, GQ, GW, KM, ML, MR, NE, SN, TD, TG). (71) Applicant: DUPONT NUTRITION BIOSCIENCES APS [DK/DK]; Langebrogade 1, 1411 Copenhagen K Declarations under Rule 4.17: (DK). — as to applicant's entitlement to apply for and be granted a patent (Rule 4.17(H)) (72) Inventors: STENMAN, Lotta; c/o Danisco Sweeteners Oy Sokeritehtaantie 20, 48210 Kotka (FI). LAHTINEN, — of inventorship (Rule 4.17(iv)) Sampo; Kotirannankuja 17A, 08350 Lohja (FI). Published: (81) Designated States (unless otherwise indicated, for every — with international search report (Art. 21(3)) kind of national protection available): AE, AG, AL, AM, AO, AT, AU, AZ, BA, BB, BG, BH, BN, BR, BW, BY, — with (an) indication(s) in relation to deposited biological BZ, CA, CH, CL, CN, CO, CR, CU, CZ, DE, DJ, DK, DM, material furnished under Rule 13bis separately from the DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, description (Rules 13bis.4(d)(i) and 48.2(a)(viii)) HN, HR, HU, ID, IL, IN, IR, IS, JP, KE, KG, KH, KN, KP, KR, KW, KZ, LA, LC, LK, LR, LS, LU, LY, MA, IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIN Al 2017/178316 (54) Title: BIFIDOBACTERIA FOR REDUCING FOOD, ENERGY AND/OR FAT INTAKE (57) Abstract: This invention relates to the use of a bacterium of the genus Bifidobacterium, particularly, but not exclusively, a bac­ terium ofthe Bifidobacterium animalis ssp. lactis strain 420 (B420) for use in reducing food, energy and/or fat intake. w o WO 2017/178316 PCT/EP2017/058206 1 BIFIDOBACTERIA FOR REDUCING FOOD, ENERGY AND/OR FAT INTAKE FIELD OF THE INVENTION This invention relates to new uses of a bacterium of the genus Bifidobacterium, particularly, but not exclusively, a bacterium of the Bifidobacterium animalis subspecies lactis strain 420 (B420). 5 This invention also relates to food products, dietary supplements and pharmaceutically acceptable formulations containing said bacterium. BACKGROUND OF THE INVENTION Regulation of energy balance is critical for the survival of an organism. When nutrients are freely available they are stored to account for low energy intake during times of scarcity. In a normal 10 state the brain, together with energy storage tissues, regulates energy balance by reducing energy intake when energy stores are congested. If the energy storage machinery is disturbed, the brain is no longer able to maintain energy balance. This could lead to inability to maintain adequate energy intake, often manifested as wilting in elderly populations, or to excess storage of energy in adipose tissue and even obesity. 15 Body mass index (BMI) is a simple index of weight-for-height that is commonly used to classify body weight status in adults. It is defined as a person's weight in kilograms divided by the square of his height in meters (kg/m2). The World Health Organisation (WHO) definition is: a BMI below 18.5 is underweight; a BMI between 18.5 and 24.99 is normal weight; a BMI greater than or equal to 25 is overweight; a 20 BMI greater than or equal to 30 is obesity. Overweight and obesity are defined as abnormal or excessive fat accumulation. Underweight is defined as a body weight that is too low to maintain normal bodily functions. Both underweight and overweight may lead to disturbances in metabolic functions, such as hormonal signalling. Once considered a high-income country problem, overweight and obesity are now on the rise in 25 low-and middle-income countries, particularly in urban settings. In developing countries with emerging economies (classified by the World Bank as lower- and middle-income countries) the WO 2017/178316 PCT/EP2017/058206 2 rate of increase of childhood overweight and obesity has been more than 30% higher than that of developed countries. Overweight and obesity are linked to more deaths worldwide than underweight. Most of the world's population live in countries where overweight and obesity kill more people than 5 underweight (this includes all high-income and most middle-income countries). The fundamental cause of obesity and overweight is an energy imbalance between calories consumed and calories expended. The most common consequences of overweight and obesity are diseases such as: cardiovascular diseases (mainly heart disease and stroke), which were the leading cause of death in 2012; 10 diabetes; musculoskeletal disorders (especially osteoarthritis - a highly disabling degenerative disease of the joints); some cancers (endometrial, breast, and colon). The risk for these diseases increases with an increase in BMI. Childhood obesity is associated with a higher chance of obesity, premature death and disability in adulthood. But in addition to increased future risks, obese children experience breathing 15 difficulties, increased risk of fractures, hypertension, early markers of cardiovascular disease, insulin resistance and psychological effects. Overweight and obesity, as well as their related diseases, are largely preventable, and the food industry can play a significant role in the fight against obesity. It is well known that dysfunctional energy regulation may lead to a variety of metabolic 20 disorders, including obesity. The connections between gut microbiota, energy homeostasis, and the pathogenesis of metabolic disorders are now well-established (Daisuke et al., Front Endocrinol (Lausanne). 2014; 5: 81). The recent publication "Neuronal regulation of Energy Homeostasis: Beyond the Hypothalamus and feeding", Michael J Waterson et al., Cell Metabolism 22, December 1, 2015, stresses the 25 importance of the brain in maintaining energy homeostasis and its relation with obesity and other metabolic diseases. WO 2017/178316 PCT/EP2017/058206 3 SUMMARY OF THE INVENTION In one aspect, the invention concerns a bacterium of the genus bifidobacterium or a mixture thereof for use in reducing food, energy and/or fat intake in a mammal. In particular, the invention concerns a bacterium of the genus Bifidobacterium or a mixture 5 thereof as a probiotic for use in reducing food, energy and/or fat intake in a mammal. In particular, the invention concerns a bacterium of the Bifidobacterium Animalis ssp. lactis strain 420 (B420). In another aspect, the invention concerns a bacterium of the genus Bifidobacterium or a mixture thereof for use in therapy to reduce food, energy and/or fat intake in a mammal. 10 In particular, the invention concerns a bacterium of the genus Bifidobacterium or a mixture thereof for use in therapy to reduce food, energy and/or fat intake in a mammal, wherein the bacterium of the genus Bifidobacterium or a mixture thereof is a probiotic. In particular, the invention concerns a bacterium of the genus Bifidobacterium or a mixture thereof for use in therapy to reduce food, energy and/or fat intake in a mammal, wherein the 15 bacterium of the genus Bifidobacterium is the Bifidobacterium of the Bifidobacterium animalis ssp. lactis strain 420 (B420). In a further aspect, the invention provides use of a bacterium of the genus Bifidobacterium or a mixture thereof for reducing food, energy and/or fat intake in a mammal. In particular, the invention provides use of a bacterium of the genus Bifidobacterium or a 20 mixture thereof as a probiotic for reducing food, energy and/or fat intake in a mammal.
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