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 .
DETAILED ACTION
Pursuant to the amendment dated 01/14/2026, claims 22-28 were cancelled and claims 29-32 were newly added. Claims 1-21 and 29-32 are pending in the instant application.
Priority
This application is a National Stage Application of PCT/US2021/052213 filed 09/27/2021 which claims benefit of 63/083,283 filed on 09/25/2020.
Information Disclosure Statement
The information disclosure statements (IDS) dated 06/22/2023, 10/11/2024, and 09/15/2025 comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, the IDS documents have been placed in the application file and the information therein has been considered as to the merits.
Election/Restrictions
Applicants’ election without traverse of the invention of Group II, claims 9-21, drawn to a method of producing an oat derived, salt precipitated β-(1,3)-(1,4) glucan having a molecular weight from about 150 kDa to about 250 kDa, a Mw/Mn ratio of about 1.0 to about 1.25, and a D3/D4 ratio of about 1.5 to less than about 2.0., in the reply filed on 01/14/2026 is acknowledged.
Claims 1-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group 1, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/14/2026.
Claims 9-21 and 29-32 are examined on the merits.
Claim Objections
Claim 10 is objected to because of the following informalities: the phrase “wherein” in the first line is duplicated. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: the phrase “effective dissolve” in the third line should be “effective to dissolve”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: the phrase “ad” in the fifth line should be “and”. Appropriate correction is required.
Claim 18 is objected to because of the following informalities: the phrase “ration” in the fourth line should be “ratio”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 9, 11-14 and 29-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Izydorczyk et al. (Journal of Cereal Science, published 01/08/1997, see PTO-892) as evidenced by Megazyme (https://www.megazyme.com/beta-glucan-oat-high-viscosity?sSearch=oat%20glucan, accessed 04/02/2026, published 09/18/2009).
Izydorczyk is drawn to the fractionation of oat (1[Wingdings font/0xE0]3), (1[Wingdings font/0xE0]4)-β-D-glucans and the characterization of the fractions (title). Izydorczyk utilizes a commercial oat (1[Wingdings font/0xE0]3), (1[Wingdings font/0xE0]4)-β-D-glucan starting material. As evidenced by Megazyme, the β-D-glucan was 94% by weight β-D-glucan (page 2).. Izydorczyk exemplifies suspending a commercial oat (1[Wingdings font/0xE0]3), (1[Wingdings font/0xE0]4)-β-D-glucan in an aqueous solution and heated to 95°C. After cooling, ammonium sulfate was added to the solution.. Izydorczyk exemplified the process in a stepwise process subsequently adjusting the saturation with increasing amounts of ammonium sulfate from 30%-50% (page 322). Izydorczyk disclosed that the DP3:4 ratio of the fractions ranged from 1.61 to 1.87 (Table III). Izydorczyk disclosed that the molecular weights of the fractions ranged from about 89 kDa to about 671 kDa (Figure 2).
Izydorczyk is silent on the Mw/Mn value of the β-glucan. However, since the β-glucan is extracted by the same method as the instant specification of suspension heating oat derived β-glucan concentrate followed by ammonium salt precipitation resulting in the same molecular weight as instantly claimed (instant specification Figure 5), the β-glucan would necessarily have the same physical properties of Mw/Mn.
Regarding instant claim 11 and 12, the instant specification defines “a mixture of salts” as “mixture of salts, such as a mixture of one or more salts selected from the group consisting of sodium chloride, potassium chloride, ammonium chloride, ammonium bromide, potassium bromide, ammonium bromide, sodium acetate, potassium acetate, ammonium acetate, ammonium sulfate, magnesium sulfate, potassium sulfate, sodium sulfate, sodiomagnesic sulfate, sodium iodide, potassium iodide, ammonium thiosulfate, potassium thiosulfate, sodium thiosulfate, and combinations thereof” (instant specification paragraph 00054). As a mixture may be comprised of just one salt, ammonium sulfate on its own meets the limitation of instant claims 11 and 12.
Regarding instant claim 13, Izydorczyk exemplified heating the oat gum to 95°C prior to cooling and undergoing ammonium sulfate fractionation (page 322). As 95°C could be considered to be about 90°C, 95°C meets the limitation.
Regarding instant claim 14, Izydorczyk exemplified four fraction steps (Figure 2).
Regarding instant claim 29, Izydorczyk discloses that 92.8% of the oligosaccharides were (1[Wingdings font/0xE0]3), (1[Wingdings font/0xE0]4)-β-D-glucans (Table III).
Regarding instant claim 30, Izydorczyk is silent on the % weight of protein and fat of the β-glucan. However, since the β-glucan is extracted by the same method as the instant specification of suspension heating oat derived β-glucan concentrate followed by ammonium salt precipitation resulting in the same molecular weight as instantly claimed (instant specification Figure 5), the β-glucan would necessarily have the same physical properties.
Regarding instant claim 31, Izydorczyk is silent on the property of the β-glucan modulating THP1 cells into cells with DC like phenotype upon administration. However, since the β-glucan is extracted by the same method as the instant specification of suspension heating oat derived β-glucan concentrate followed by ammonium salt precipitation resulting in the same molecular weight as instantly claimed (instant specification Figure 5), the β-glucan would necessarily have the same physical properties and therefore meets the limitations of instant claim 31.
Regarding instant claim 32, Izydorczyk is silent on the property of the β-glucan having an endotoxin level less than about 5 EU/kg. However, since the β-glucan is extracted by the same method as the instant specification of suspension heating oat derived β-glucan concentrate followed by ammonium salt precipitation resulting in the same molecular weight as instantly claimed (instant specification Figure 5), the β-glucan would necessarily have the same physical properties and therefore meets the limitations of instant claim 32.
Accordingly, the instant claims are anticipated by the prior art.
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 9, 14-17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Izydorczyk et al. (Journal of Cereal Science, published 01/08/1997, see PTO-892).
Claims 9 and 14 are rejected as discussed above.
The teachings of Izydorczyk are discussed above.
Izydorczyk further teaches that the ammonium sulphate precipitated material was collected by centrifugation, salt was removed by dialysis, and the resulting precipitate was dried resulting in the fractionation (page 322).
Izydorczyk does not exemplify that the first supernatant has a maximum β-glucan molecular weight less than about 230 kDa.
It would have been prima facie obvious before the effective filing date of the claimed invention to optimize the concentration of the ammonium sulfate of the first fractionation step in order to obtain a first supernatant that as a maximum β-glucan molecular weight less than about 230 kDa and a second supernatant that as a maximum β-glucan molecular weight less than about 190 kDa as taught by Izydorczyk to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to optimize the concentration of the ammonium sulfate of the first fractionation step in order to obtain a first supernatant that as a maximum β-glucan molecular weight less than about 230 kDa and a second supernatant that as a maximum β-glucan molecular weight less than about 190 kDa because Izydorczyk teaches that the maximum β-glucan molecular weight is a function of the concentration of ammonium sulfate with larger molecular weight β-glucans precipitating at lower concentrations of ammonium sulfate and smaller molecular weight β-glucan precipitating at higher concentrations of ammonium sulfate. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). (MPEP § 2144.05(I)) Moreover, 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. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). (MPEP § 2144.05(II)) “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.” In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Izydorczyk et al. (Journal of Cereal Science, published 01/08/1997, see PTO-892) as applied to claims 9 and 14-17 above, and further in view of Li et al. (Carbohydrate Polymers, published 11/14/2005, see PTO-892).
Claims 9 and 14-17 are rejected as discussed above.
Izydorczyk does not teach the method further comprising adding an alcohol to the dialyzed aqueous solution to precipitate the β-glucan.
Li is drawn to the extraction, fractionation, structural and physical characterization of wheat β-glucans (title). Li teaches a method of fractionating wheat β-glucans using the gradual ammonium sulphate precipitation method (page 409). The precipitated was dissolved in water and dialyzed against deionized water then precipitated by equal volume of isopropanol (page 410, see Fig. 1).
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It would have been prima facie obvious to combine the teachings of Izydorczyck and Li before the effective filing date by modifying the method of fractionating and isolating the β-glucan taught by Izydorczyk by adding the step of adding alcohol after the dialysis step of the precipitate to further precipitate the fraction for fractionating and isolating the β-glucan as taught by Li to arrive at the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to modify the method taught by Izydorczyk by adding the step of adding an alcohol because Li teaches the addition of isopropanol to the method of using the gradual ammonium sulphate precipitation method for the extraction and fractionation of β-glucans. One of ordinary skill in the art would have a reasonable expectation of success because both Izydorczyk and Li utilize the method of using the gradual ammonium sulphate precipitation method for the extraction and fractionation of β-glucans and Li adds a step of isopropanol precipitation.
Conclusion
No claims allowed.
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/SAMANTHA LYNN SCHACHERMEYER/Examiner, Art Unit 1693 /SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693