US2020188481A1PendingUtilityA1

Nutritive Polypeptides and Formulations Thereof, and Methods of Production and Use Thereof

72
Assignee: AXCELLA HEALTH INCPriority: Sep 25, 2013Filed: Sep 27, 2019Published: Jun 18, 2020
Est. expirySep 25, 2033(~7.2 yrs left)· nominal 20-yr term from priority
G16B 20/50C07K 14/77A61K 9/0075C07K 14/76A61K 9/2866A61K 38/1767A23L 2/66A61P 29/00A61K 38/17A61K 9/2054G16B 20/00A23L 33/30G01N 33/60C12Y 207/04003A61K 38/164A61K 38/45A61K 38/1709A61K 9/146A23L 33/175A23L 33/17A61K 38/1703A61P 35/04A23V 2002/00A61K 9/00A61P 43/00A23L 33/18G01N 33/6806A61P 3/04A61K 38/16A61K 9/0095A61P 9/10A61K 38/00A61K 9/0053C07K 14/415A61P 21/06A61P 31/06A23L 33/40A61P 35/00A61K 45/06A23L 33/195A61P 3/02A61K 38/10A61P 31/18G01N 2500/00A61P 1/16A61K 38/38A61P 37/00A61P 35/02A61K 38/168A61P 19/10A61P 37/06G01N 33/6848A61P 31/14G01N 33/6803A61P 3/10A61P 21/00
72
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Claims

Abstract

Nutritive polypeptides are provided herein. Also provided are various other embodiments including nucleic acids encoding the polypeptides, recombinant microorganisms that make the polypeptides, vectors for expressing the polypeptides, methods of making the polypeptides using recombinant microorganisms, compositions and formulations that comprise the polypeptides, and methods of using the polypeptides, compositions and formulations.

Claims

exact text as granted — not AI-modified
1 .- 62 . (canceled) 
     
     
         63 . A formulation comprising a nutritive polypeptide component consisting essentially of a isolated single chain nutritive polypeptide having an amino acid sequence at least about 90% identical to an edible species polypeptide sequence or fragment thereof at least 50 amino acids in length, wherein the nutritive polypeptide is present in an amount sufficient to provide a nutritional benefit equivalent to or greater than at least about 2% of a reference daily intake value of protein, and wherein the formulation is substantially free of non-comestible products, and wherein the nutritive polypeptide has less than about 50% identity over at least 25 amino acids to a known allergen. 
     
     
         64 . A unit dose comprising an isolated nutritive polypeptide having an amino acid sequence at least about 90% identical to an edible species polypeptide or fragment thereof at least 50 amino acids in length, wherein the nutritive polypeptide is present in the unit dose at a concentration of above about 0.5% by weight, wherein the formulation is substantially free of non-comestible products, and wherein the nutritive polypeptide has less than about 50% identity over at least 25 amino acids to a known allergen. 
     
     
         65 . The unit dose of  claim 64 , wherein the nutritive polypeptide is present at a concentration between about 0.5% and about 90% by weight, wherein the formulation is present as a liquid, semi-liquid or gel in a volume not greater than about 500 ml. 
     
     
         66 . The unit dose of  claim 64 , wherein the nutritive polypeptide is present at a concentration between about 0.5% and about 99% by weight, wherein the formulation is present as a solid or semi-solid in a total mass not greater than about 200 g. 
     
     
         67 . The formulation of  claim 63 , wherein the edible species polypeptide comprises an agriculturally-derived food protein. 
     
     
         68 . The formulation of  claim 63 , wherein the nutritive polypeptide is at least about 90% identical to a polypeptide selected from the group consisting of SEQID-40319 to SEQID42840. 
     
     
         69 . The formulation of  claim 63 , wherein the edible species polypeptide comprises a nutritional domain of an agriculturally-derived food protein. 
     
     
         70 . The formulation of  claim 63 , wherein the edible species polypeptide is a present in a nutritionally substantial quantity in the diet of a human population. 
     
     
         71 . The formulation of  claim 63 , wherein the edible species polypeptide is a bovine, ovine, caprine, porcine, piscine, or galline protein. 
     
     
         72 . The formulation of  claim 63 , wherein the edible species polypeptide is a leaf vegetable protein. 
     
     
         73 . The formulation of  claim 63 , wherein the edible species polypeptide is a seed or fruit protein. 
     
     
         74 . The formulation of  claim 63 , wherein the edible species polypeptide is an edible flower or sea vegetable protein. 
     
     
         75 . The formulation of  claim 63 , wherein the edible species polypeptide is a legume protein. 
     
     
         76 . The formulation of  claim 63 , wherein the edible species polypeptide is a bulb, stem, root, or tuber protein. 
     
     
         77 . The formulation of  claim 63 , wherein the edible species polypeptide is a fungal protein. 
     
     
         78 . The formulation of  claim 63 , wherein the edible species polypeptide is of microbial origin. 
     
     
         79 . The formulation of  claim 63 , wherein the nutritive polypeptide is present in the formulation at a concentration greater than the edible species polypeptid is present in an edible portion of the edible species. 
     
     
         80 . The formulation of  claim 63 , wherein the nutritive polypeptide is present in the formulation substantially free of associated proteins. 
     
     
         81 . The formulation of  claim 63 , wherein the nutritive polypeptide has a percentage content of one or more branched chain amino acids greater than about 23.67%. 
     
     
         82 . The formulation of  claim 63 , wherein the nutritive polypeptide has a percentage content of one or more essential amino acids greater than about 49.04%. 
     
     
         83 . The formulation of  claim 63 , wherein the nutritive polypeptide is present in an amount sufficient to provide a healthy adult male human subject with at least about 25% of a reference daily intake value of protein. 
     
     
         84 . The formulation of  claim 63 , wherein the nutritive polypeptide is present in an amount sufficient to provide a healthy adult female human subject with at least about 25% of a reference daily intake value of protein. 
     
     
         85 . The formulation of  claim 63 , wherein the nutritive polypeptide is present in an amount sufficient to provide a pregnant human subject with at least about 10% of a reference daily intake value of protein. 
     
     
         86 . The formulation of  claim 63 , wherein the nutritive polypeptide is produced by a microorganism. 
     
     
         87 . The formulation of  claim 63 , wherein the nutritive polypeptide is produced by a microorganism, and wherein the nutritive polypeptide is substantially separated from the microorganism. 
     
     
         88 . The formulation of  claim 63 , wherein the nutritive polypeptide is secreted by a microorganism. 
     
     
         89 . The formulation of  claim 63 , wherein the nutritive polypeptide is produced by a heterotrophic microorganism. 
     
     
         90 . The formulation of  claim 63 , wherein the nutritive polypeptide is produced by a autotrophic microorganism. 
     
     
         91 . The formulation of  claim 63 , wherein the nutritive polypeptide is produced by a mixotrophic microorganism. 
     
     
         92 . The formulation of  claim 63 , wherein the nutritive polypeptide is produced by a microorganism comprising an exogenous nucleic acid sequence. 
     
     
         93 . The formulation of  claim 63 , wherein the nutritive polypeptide comprises an amino acid sequence at least about 90% identical to an edible species polypeptide present in an amount of at least about 1% total protein weight in an edible species, the food species representing at least about 1% of the diet of a human population. 
     
     
         94 . The formulation of  claim 63 , wherein the nutritive polypeptide comprises an amino acid sequence at least about 90% identical to an edible species polypeptide present in an amount of at least about 0.1% total weight in a dehydrated food species, the edible species representing at least about 0.1% of the diet of a human population. 
     
     
         95 . The formulation of  claim 63 , comprising at least about 5 grams of the nutritive polypeptide. 
     
     
         96 . The formulation of  claim 63 , comprising at least one agriculturally-derived carbohydrate and/or lipid. 
     
     
         97 . The formulation of  claim 63 , comprising at least one agriculturally-derived protein. 
     
     
         98 . The formulation of  claim 63 , further comprising a tastant or flavorant. 
     
     
         99 . The formulation of  claim 63 , further comprising a vitamin or mineral. 
     
     
         100 . The formulation of  claim 63 , in a liquid, solid, semi-solid, or gel state at room temperature. 
     
     
         101 . The formulation of  claim 63 , formulated for administration as an infant formula, an elderly nutritional formula, a prenatal nutrition formula, an athletic performance formula, a ready-to-use therapeutic food formula, or an athletic recovery formula. 
     
     
         102 . The formulation of  claim 63 , formulated for administration as a medical food. 
     
     
         103 - 106 . (canceled) 
     
     
         107 . The formulation of  claim 63 , wherein an allergenic protein or a polypeptide at least 25% homologous to a known allergen is not substantially present in the formulation. 
     
     
         108 . The formulation of  claim 63 , wherein a polypeptide having an allergenic protein or a protein at least 90% identical to an allergenic protein is not substantially present in the formulation. 
     
     
         109 . The formulation of  claim 63 , wherein an anti-nutritive polypeptide or a polypeptide comprising an anti-nutritive domain is not substantially present in the formulation. 
     
     
         110 . The formulation of  claim 63 , wherein a wheat protein isolated from a wheat grain is not substantially present in the formulation. 
     
     
         111 . The formulation of  claim 63 , wherein a soy protein is not substantially present in the formulation. 
     
     
         112 . The formulation of  claim 63 , wherein a dairy protein is not substantially present in the formulation. 
     
     
         113 .- 176 . (canceled)

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