DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Application
The claims filed 25 September 2025 have been entered. Claims 1-9 and 21-24 are pending. Claims 10-20 have been cancelled. The previous objections to the claims have been withdrawn in view of applicant’s amendments to the claims. The previous 112 rejections have been withdrawn in view of applicant’s amendments to the claims. The previous 102 rejections have been withdrawn in view of applicant’s amendments to the claims. The previous 103 rejections have been modified in view of applicant’s amendments to the claims.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 24 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 recites “wherein the aqueous solution consists essentially of the beta-glucan.” It is unclear how an aqueous solution, which must necessarily contain water, can consist of only the beta glucans. In the Remarks Applicant points to [0115-0116] for support of new claim 24. Applicant appears to be referring to the PGPub 2023/0028844 A1 which corresponds to p23, lines 24-34 of the specification on file. For clarity, it is requested in the future that applicant's remarks only refer to documents in the file wrapper. The specification (p23, lines 24-34) recite a beta-glucan powder that is reconstituted into water and centrifuged to separate the soluble beta glucan portion from the insoluble portion. The specification further recites: for use in the nutritional composition the aqueous solution can be diluted to the desired consistency or mixed with other ingredients as desired. For the purpose of examination, claim 24 will be interpreted as: wherein the aqueous solution consists of water and the beta-glucan.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9 and 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Burbidge (WO 2013/087918, published 20 June 2013) in view of Lazaridou (A. Lazaridou et al., Molecular size effects on rheological properties of oat β-glucans in solution and gels, Food Hydrocolloids, Volume 17, Issue 5, 2003, Pages 693-712, ISSN 0268-005X, https://doi.org/10.1016/S0268-005X(03)00036-5).
Regarding claim 1, Burbidge discloses a nutritional product comprising an aqueous solution of a food grade biopolymer capable of providing to the nutritional product a shear viscosity of less than about 100 mPas when measured at a shear rate of 50s-1 and a relaxation time, determined by a Capillary Breakup Extensional Rheometry (CaBER) experiment, of more than 10 ms at a temperature of 20oC [0021]. Burbidge’s shear viscosity of less than about 100 mPas falls within the claimed range of less than 200 mPas, thus anticipating the range.
Burbidge discloses the biopolymer is comprised in the aqueous solution in a concentration from 1-10 wt%, which falls within the claimed range of 0.01-10 wt% and thus anticipates the range [0025].
Burbidge further discloses the food grade biopolymer can be selected from botanical hydrocolloids [0027].
Burbidge does not disclose the botanical hydrocolloid is β-glucans consisting of homopolysaccharides of D-glucopyranose monomers linked by (1[Wingdings font/0xE0]3), (1[Wingdings font/0xE0]4)-β-glycosidic bonds.
Lazaridou, in the field of food hydrocolloids, discloses β-glucans can impart viscosity to aqueous solutions and can be used as food hydrocolloids. β-glucans, because of their high viscosity in solutions, can be utilized as thickening agents. Lazaridou discloses oat β-D-glucans are a functional bioactive ingredient with the biological benefits of reducing plasma cholesterol and postprandial serum glucose levels in humans and animals. These properties stem from their solubility in water and capacity to form highly viscous solutions (p694, LH column, last paragraph). Lazaridou discloses native β-glucans from cereals (including oats) are linear homopolysaccharides composed of D-glucopyranosyl residues linked via a mixture of β-(1[Wingdings font/0xE0]3) and β-(1[Wingdings font/0xE0]4) linkages (693, Introduction, first paragraph).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have selected the cereal β-glucans of Lazaridou as the botanical hydrocolloids of Burbidge because Lazaridou discloses the cereal β-glucans are food hydrocolloids appropriate to form highly viscous solutions and provide the advantages of lowering plasma cholesterol levels and postprandial serum glucose levels in animals and humans.
Regarding claim 2, Burbidge in view of Lazaridou discloses the nutritional product of claim 1 as discussed above. Burbidge discloses a shear viscosity of less than about 100 mPas at a shear rate of 50s-1 [0021]. The value of “less than about 100 mPas” is considered to include values of less than 100 mPas, less than 101 mPas, etc. Therefore the disclosure of Burbidge of less than about 100 mPas is considered to overlap with the claimed range of between 100 to 200 mPas. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I.
Regarding claim 3, Burbidge in view of Lazaridou discloses the nutritional product of claim 1 as discussed above. Burbidge discloses a shear viscosity of less than about 100 mPas at a shear rate of 50s-1 [0021]. The specification discloses that shear viscosity is often referred to simply as viscosity (p 10, lines 9-10). Burbidge also discloses a known treatment for beverages and liquid foods is to increase the velocity of the food or beverage by adding starch or gum thickeners. [00111].
Therefore it is known that the amount of gum thickeners in a nutritional product is a result effective variable. Change the amount of the gum thickener and you change the viscosity of the nutritional product. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. Additionally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. MPEP 2144.05 II A. Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the product disclosed by the prior art by normal optimization procedures known in the art.
Regarding claim 4, Burbidge discloses it is preferred that the relaxation time is less than about 2000 ms at a temperature of 20oC [0023], which encompasses the claimed range of 10-2000ms. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 I.
Regarding claim 5, Burbidge discloses in another preferred embodiment of the first aspect of the invention, the filament diameter of the nutritional product decreases less than linearly in time during a CaBER experiment [0024].
Regarding claims 6 and 24, Burbidge discloses the only required ingredients of the composition are a food grade biopolymer and water (and aqueous solution) [0021]. All other ingredients are optional. Burbidge discloses the biopolymer is comprised in the aqueous solution in a concentration from 1-10 wt% [0025]. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have elected to include only the water and biopolymer in the nutritional product, where the biopolymer is present from 1-10 wt%.
Regarding claim 7, Burbidge discloses a preferred embodiment where the nutritional product is in diluted form [0026].
Regarding claim 8, Burbidge discloses the nutritional product includes a prebiotic, a probiotic, an amino acid, a fatty acid, a phytonutrient, an antioxidant, protein, fiber, fat and carbohydrate [0033-0038], [00131], [00140], [00154] and [00155].
Regarding claim 9, Burbidge discloses the nutritional product is in an administrable form selected from the group consisting of pharmaceutical formulations, nutritional formulations, dietary supplements, functional food and beverage products or combinations thereof [0039].
Regarding claim 21, it is noted the claims are drawn to a final nutritional product and claim 21 recites limitations of the aqueous solution included in the final nutritional product. A final nutritional product made where, for example, a flavor agent is added to the aqueous solution and then the aqueous solution plus flavor agent is added to the remaining ingredients will be indistinguishable from a nutritional product where the aqueous solution is combined with the flavor agent and remaining ingredients simultaneously. The patentability of a product does not depend on its method of production. MPEP 2113 I. As such, Burbidge discloses the nutritional compositions can include additional ingredients including acidulants, additional thickeners, buffers or agents for pH adjustment, chelating agents, colorants, emulsifies, excipient, flavor agent, mineral, osmotic agents, a pharmaceutically acceptable carrier, preservatives, stabilizers, sugar, sweeteners, texturizers, and/or vitamins [0080]. The order in which the ingredients are added does not provide a patentable distinction over the prior art. Selection of any order of mixing ingredients is prima facie obvious. MPEP 2144.04 IV. C.
Regarding claim 22, Burbidge discloses the relaxation time is preferably from 20-1000ms, 50-500ms at a temperature of 20o C [0023].
Regarding claim 23, it is noted the claims are drawn to a final nutritional product and claim 23 recites limitations as to method steps of diluting the final nutritional product of claim 1. The claims are not drawn to a method of making a further product which includes the claimed nutritional product. Regardless, Burbidge discloses a nutritional product in diluted form, preferably in a dilution ranging from 2:1 to 50:1 [0026].
Response to Arguments
Applicant's arguments filed 25 September 2025 have been fully considered. To the extent they apply to the above rejection they are not persuasive.
Applicant argues Burbidge as evidenced by Chang does not teach the newly amended claim limitation of β-glucans consisting of homopolysaccharides of D-glucopyranose monomers linked by (1[Wingdings font/0xE0]3), (1[Wingdings font/0xE0]4)-β-glycosidic bonds. Remarks pp6-7.
This argument is not persuasive. As detailed in the claim 1 rejection above, Lazaridou is relied upon to disclose the β-glucans consisting of homopolysaccharides of D-glucopyranose monomers linked by (1[Wingdings font/0xE0]3), (1[Wingdings font/0xE0]4)-β-glycosidic bonds which are known to be found in cereals such as oats and oat β-glucans are known to be used as viscosity agents with beneficial effects on cholesterol and serum glucose levels of animals and humans.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/C.L.G./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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