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 .
This application is the national stage entry of PCT/JP2021/046460, filed 16 Dec 2021; and claims benefit of foreign priority document JAPAN 2020-216129, filed 25 Dec 2020. This foreign priority document is not in English.
Claims 1-20 are pending in the current application and are examined on the merits herein.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sunako et al. (WO 2020/090997 A1, published 07 May 2020, provided by Applicant in IDS filed 09 June 2023, English language equivalent US 2022/0002443 cited in PTO-892).
Hereafter, citations to Sunako et al. will be found in the patent family member US 2022/0002443 because WO 2020/090997 is not in English.
Sunako et al. discloses a resistant starch and a method for producing a resistant starch which involves a step for mixing a raw material starch and an acid and subjecting the mixture to conditions in which the resistant starch is generated (abstract). Sunako et al. discloses the working example A in which An acid containing preparation was obtained by mixing 5 parts of juice and 10 parts of water. 100 parts of raw material starch was mixed with 15 parts of acid containing preparation in terms of mass (or a raw starch material which comprises an acid-treated starch). The pH was adjusted using sodium hydroxide (where the raw material mixture implicitly includes the components in an aqueous solution, or preparing the raw material mixture comprising the raw starch material and an aqueous alkaline solution). The mixture was heated for 4 hours at 150 °C. using a shelf dryer (ESPEC Corp.) (corresponding to step (b)). Subsequently, the mixture was washed twice with 200 parts of water, dehydrated, and dried to obtain a resistant starch (paragraph 129 spanning pages 9-10). This meets limitations of steps (a) and (b) in claim 1, and implicitly limitations of claim 9. In a certain embodiment, a mixture of a starch and an acid does not need to be processed to be anhydrous by preliminary drying prior to a condition that generates a resistant starch, and can be subjected directly to a condition that generates a resistant starch. The amount of moisture in a mixture of a starch and an acid is particularly preferably 25 to 30% (page 8, paragraph 112), meeting limitations of the moisture content in claim 1 and expressly meeting limitations of claim 9.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 12, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Sunako et al. (WO 2020/090997 A1, published 07 May 2020, provided by Applicant in IDS filed 09 June 2023, English language equivalent US 2022/0002443 cited in PTO-892).
Sunako et al. teaches regarding claims 1 and 9 as above. Sunako et al. further teaches the amount of juice added to a starch, in equal units, is preferably 0.5 to 50 % by weight, more preferably 2.0 to 20 % by weight, and most preferably 5.0 to 10 % in terms of percentage solids by weight (page 8, paragraph 107). Sunako et al. further teaches in some embodiments the manufacturing method further comprises the step of washing the resistant starch product with water. The washing step attains an advantageous effect because the washing step removes juice components and alkaline impurities in the product and bleaches the product to improve the electrical conductivity of the product and the flavor (paragraphs 114 spanning pages 8-9).
Sunako et al. does not specifically disclose the mass ratio of the raw starch material is 56 parts by mass or more and 79 parts by mass or less to 100 parts by mass of the raw material mixture (claim 2 and 19). Sunako et al. does not specifically disclose the method further comprising washing the heat-treated product obtained in step (b) by adding water and a pH adjuster (claim 12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Sunako et al. in order to select the optimal amount of juice added to a raw starch material to give the total raw material mixture, or to optimize the washing step. Regarding the ratio of raw starch material to total raw material mixture, one of ordinary skill in the art would have been motivated to modify the teachings of Sunako et al. with a reasonable expectation of success because Sunako et al. teaches the working example comprising 100 parts of raw material starch mixed with 15 parts of acid containing preparation (which is 100/115 or 87 parts by mass of raw material starch), and teaches the amount of juice added to a starch, in equal units, is preferably 0.5 to 50% by weight, suggesting it would have been routine experimentation to select the optimum amount of acid and amount of raw starch material relative to the total raw material mixture, and Sunako et al. provides guidance in the working example as a starting point for optimization. Regarding the washing by adding water and a pH adjuster, one of ordinary skill in the art would have been motivated to modify the teachings of Sunako et al. with a reasonable expectation of success because Sunako et al. teaches the washing step removes juice components and alkaline impurities in the product, where the juice components are the acid-containing preparation, suggesting the washing is intended to remove both acid and alkaline impurities, and Sunako et al. in the working example suggest the process includes adding acid and alkaline components that adjust the pH, therefore it would have been obvious to one of ordinary skill in the art to modify the washing step by further adding a pH adjuster into the washing solution.
Claims 3-4, 6-8 13-14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Sunako et al. (WO 2020/090997 A1, published 07 May 2020, provided by Applicant in IDS filed 09 June 2023, English language equivalent US 2022/0002443 cited in PTO-892) in view of Shi et al. (EP 1102792 A1, published 30 May 2001, abstract only provided by Applicant in IDS filed 03 Jan 2025, EP 1102792 B1 cited in PTO-892).
Sunako et al. teaches regarding claims 1-2, 9, 12, and 19 as above. Sunako et al. further teaches the resistant starch shows thermal resistance (page 3, paragraph 49).
Sunako et al. does not specifically teach mass ratio of the acid-treated starch or the dextrin (claims 3-4, 13-14). Sunako et al. does not specifically teach the DE (dextrose equivalent: degree of degradation) of the dextrin is 5 or higher but less than 50 (claim 6, 16). Sunako et al. does not specifically teach the dextrin is an aqueous dextrin solution (claim 7, 17). Sunako et al. does not specifically teach an alkali used in the aqueous alkaline solution is one or more selected from the group consisting of calcium hydroxide, sodium carbonate, calcium carbonate, potassium carbonate, sodium hydrogen carbonate, and dipotassium hydrogen phosphate (claim 8, 18).
Shi et al. teaches the process of thermally treating starch in the presence of an oligosaccharide, wherein the oligosaccharide contain from 1 to 20 sugar units, to improve the rate of thermal inhibition of the starch (page 2, paragraph 1). The starches used may be conversion products derived from typical starches, such as prepared by acid hydrolysis, or heat and/or acid dextrinization (page 3, paragraph 12). The blend of starch to oligosaccharide may be in any ratio which allows for hastened inhibition, particularly from about 85:15 to 99:1, more particularly from about 93:7 to 98:2, addressing limitations of claims 3-4 and 13-14. Shi et al. teaches the working example 1 in which corn starch (935 g) and Maltrin M200 (165g) were slurried in water (1500 ml) in a stainless steel beaker and mixed. The slurry was adjusted to pH 9.5 by addition of sodium carbonate, air dried, and heated in an oven at 150 °C (page 7, paragraph 70). Shi et al. teaches examples of the dextrins having DE of 7.1, 24.8, and 42.6 (page 7, paragraph 69), addressing limitations of claims 6 and 16. Shi et al. teaches suitable bases for the pH adjustment step include, but are not limited to, sodium hydroxide, sodium carbonate, calcium carbonate, calcium hydroxide, and potassium carbonate. A particularly suitable base is sodium carbonate (page 4, paragraph 25), addressing limitations of claims 8 and 18.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Sunako et al. in view of Shi et al. in order to improve the method of Sunako et al. in the same manner taught by Shi et al. and to select the optimal amount of the acid-treated starch or the dextrin through routine experimentation. One of ordinary skill in the art would have been motivated to combine Sunako et al. in view of Shi et al. with a reasonable expectation of success because both Sunako et al. and Shi et al. are drawn to methods of thermally treating starch in order to improve the rate of thermal resistance of the starch, and Shi et al. suggests this product is improved by thermally treating starch in the presence of an oligosaccharide or dextrin, suggesting it would have been obvious to improve similar methods in the same way. Regarding claims 3 and 13, Shi et al. suggests this dextrin may be prepared from starch by acid hydrolysis or acid dextrinization, suggesting it would have been obvious to select the dextrin to be an acid-treated starch. Regarding the optimal amount of the acid-treated starch or the dextrin, Shi et al. teaches selection of the ratio of the starch to oligosaccharide and provides guidance of ratios of about 93:7 to 98:2 as a starting point, suggesting it would have been obvious to select the optimal ratio through routine experimentation within the suggested range. Regarding claims 7 and 17, both Sunako et al. and Shi et al. teach the mixture of components in water, suggesting it would have been obvious to provide the alkali and the dextrin as an aqueous solution. Regarding claims 8 and 18 and selection of a suitable base for the pH adjustment step, Shi et al. suggests it would have been obvious to substitute the sodium hydroxide taught by Sunako et al. for a different suitable base and provides guidance to select the preferred base sodium carbonate.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Sunako et al. (WO 2020/090997 A1, published 07 May 2020, provided by Applicant in IDS filed 09 June 2023, English language equivalent US 2022/0002443 cited in PTO-892) in view of Shi et al. (EP 1102792 A1, published 30 May 2001, abstract only provided by Applicant in IDS filed 03 Jan 2025, EP 1102792 B1 cited in PTO-892), further in view of Singh et al. (Carbohydrate Polymers, 2000, 41, p191–195, cited in PTO-892).
Sunako et al. in view of Shi et al. teaches as above. Sunako et al. further teaches suitable starches for use in the method include potato starch (page 10, table C). Shi et al. further teaches typical sources for the starches used in the method include can be the potato (paragraph 11 spanning pages 2-3).
Sunako et al. in view of Shi et al. does not specifically teach the number-average molecular weight of the acid-treated starch is 250,000 or more and 500,000 or less (claims 5, 15).
Singh et al. teaches the molecular weight of starches from typical sources is known, and that the molecular weight (number average, Mn) of these starches decreased after acid modification (page 191, abstract). Singh et al. teaches number average molecular weight of potato starch is 335 KD, and after acid modification ranges from 81 KD to 303 KD (page 192, table 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Sunako et al. in view of Shi et al. further in view of Singh et al. and to recognize the selection of the starch used would predictably affect the number average molecular weight of the resulting acid-treated starch. One of ordinary skill in the art would have been motivated to combine Sunako et al. in view of Shi et al. further in view of Singh et al. with a reasonable expectation of success because both Sunako et al. and Shi et al. are drawn to methods of thermally treating starch in order to improve the rate of thermal resistance of the starch and suggest the raw starch material to be acid-treated, Sunako et al. teaches selection of starch from different sources such as potato starch, and Singh et al. teaches the molecular weight of starches from typical sources is known and the resulting number average molecular weight after acid-treatment would have been predictable and that selection of potato starch would have made obvious an acid-treated starch having the number average molecular weight as claimed.
Claims 10-11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Sunako et al. (WO 2020/090997 A1, published 07 May 2020, provided by Applicant in IDS filed 09 June 2023, English language equivalent US 2022/0002443 cited in PTO-892) in view of Shi et al. (EP 1102792 A1, published 30 May 2001, abstract only provided by Applicant in IDS filed 03 Jan 2025, EP 1102792 B1 cited in PTO-892), further in view of Kawai et al. (US 2014/0087052, published 17 March 2014, cited in PTO-892).
Sunako et al. in view of Shi et al. teaches as above. Shi et al. further teaches the thermally-inhibited starch/oligosaccharide blends are useful in foods such as full-fat or fat-reduced foods (page 6, paragraph 62).
Sunako et al. in view of Shi et al. does not specifically disclose the raw material mixture further contains an edible oil/fat (claims 10 and 19).
Kawai et al. teaches an oil- or fat-processed starch and a method for producing thereof, useful in the field of foods (page 1, paragraph 1-2). Kawai et al. teaches the method includes the step in which the mixture of the starch, the pH adjuster and the edible oil or fat and/or the edible oil- or fat-related substance are heated to obtain the oil- or fat-processed starch, which exhibits the effect for improving the quality of the solid or gelatinous food such as the edible meat and the like (page 4, paragraph 59-60). The blending ratio of the edible oil or fat in the mixture is, for example, equal to or higher than 0.005% by mass over 100 parts by mass of the raw starch, in view of firmly obtaining the effect for reforming the starch, more preferably equal to or higher than 0.02 parts by mass, and preferably equal to or lower than 1.5 parts by mass (page 3, paragraph 49).
It would have been obvious to one of ordinary skill in the art to combine Sunako et al. in view of Shi et al. further in view of Kawai et al. in order to improve the product made by the method of Sunako et al. in view of Shi et al. in the same way as taught by Kawai et al. One of ordinary skill in the art would have been motivated to combine Sunako et al. in view of Shi et al. further in view of Kawai et al. with a reasonable expectation of success because all of Sunako et al., Shi et al. and Kawai et al. teach a method of producing a starch material comprising thermally treating a mixture of a starch and a pH adjuster, and Kawai et al. teaches addition of an edible oil or fat to the mixture that is heat-treated improves the properties of the starch material produced. Regarding claim 11, Kawai et al. provides guidance for the selection of the blending ratio of the edible oil or fat to the raw starch based on the preferred ranges, suggesting it would have been obvious to select the optimal ratio through routine experimentation within the ranges taught in Kawai et al.
Conclusion
No claim is found to be allowable.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693