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 office action is in response to the application filed on March 9, 2023. The earliest effective filing date of the application is September 11, 2020.
Priority
The present application is a 371 National Stage Application of PCT/EP2021/074938 which has a filing date of September 10, 2021.
Status of Application
The amendment filed April 22, 2026 with the Remarks has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1, 4 – 11, and 18 – 23
Withdrawn claims: None
Previously cancelled claims: 2, 3, and 12 – 17
Amended claims: 1, and 18 – 20
New claims: 21 – 23
Claims currently under examination: 1, 4 – 11, and 18 – 23
By not repeating the previously presented objection/rejection(s), it is sufficiently clear that said objection/rejection(s) are withdrawn.
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 23 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 23 recites “the high fiber, phase stable liquid has a volume of at least 50% (v/v)” which renders the claim indefinite. Claim 23 fails to disclose the basis of (v/v) in the high fiber, phase stable liquid, specifically what is considered to be the total volume if the product of the method of claim 23 is the high fiber, phase stable liquid. The basis of (v/v) is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, (v/v) is interpreted to be the volume of the high fiber, phase stable liquid in the final product of the method of claim 23 (which is interpreted to be the high fiber, phase stable liquid).
Claim Rejections - 35 USC § 103
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 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 1, 4 – 6, 9 – 11, 19, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Kunio (JP 2001204415 A) in view of Elleuch et al. (Dietary fibre and fibre-rich by-products of food processing: Characterisation, technological functionality and commercial applications: A review. Food Chemistry. Vol 124. Pp. 411 – 421. (2011), and as evidenced by Liu (14 - Food Use of Whole Soybeans In: Soybeans – Chemistry, Production, Processing, and Utilization. Pp. 441 – 481. (2008)).
Regarding claims 1 and 19, Kunio teaches a method of producing okara milk (i.e., a high fiber, phase stable liquid) comprising the steps of:
diluting 1 kg of okara (i.e., plant material) with 5 L (5 kg) of water, thereby producing a slurry comprising 16.6 wt% plant material ([0062], Example 4); then
homogenizing the slurry at 140 MPa (1400 bar – [0062], Example 4).
As evidenced by Liu, when dried, okara contains 40.2 – 43.6 wt% insoluble fiber and 12.6 – 14.6 wt% soluble fiber (p. 457, paragraph 6). According to these proportions, okara comprises 52.8 – 58.2 wt% total fiber, and of this fiber, 73.4 – 77.6 wt% of it is insoluble fiber.
Kunio does not teach the okara milk (i.e., high fiber, phase stable liquid) comprises 6g fibre/100ml.
Elleuch teaches the food industry can take advantage of the physicochemical properties of dietary fiber to improve the viscosity, texture, sensory characteristics and shelf-life of their products (p. 418, paragraph 6). Elleuch teaches the literature contains many reports about additions of dietary fibre to food products such as beverages, dairy, and frozen dairy (p. 418, paragraph 7). Elleuch teaches viscosity, resistance to flow, is defined as the ratio of shear stress to shear rate (p. 416, paragraph 7). Elleuch teaches most polysaccharide solutions exhibit non-Newtonian flow and an increased shear rate can increase or decrease viscosity (p. 416, paragraph 7). Elleuch teaches water soluble fibres are the major component that would increase the viscosity of a solution (p. 416, paragraph 7). Elleuch teaches viscosity increases with an increased fibre concentration but decreases with the temperature of a solution of dietary fibre (p. 417, paragraph 2). Therefore, the fiber content of a beverage is a result-effective variable because increasing the fiber content of a beverage controllably increases its viscosity.
Kunio and Elleuch are combinable because they are concerned with the same field of endeavor, namely, beverages that contain fiber. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have adjusted the amount of fiber in the okara milk during routine optimization to find the final okara milk product with the desired viscosity. MPEP §2144.05(II) states where 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). The claimed fiber content in the high fiber, phase stable liquid, 6 g/ 100 ml, would thus be obvious.
Regarding claim 4, Kunio teaches bean curd refuse (i.e., okara) in the form of slurry or liquid obtained by adding water to bean curd refuse is pretreated at several to several hundreds of MPa by a high-pressure homogenizing 5A (symbol A1 in the figure), followed by micronization, disruption of cellular tissue, microemulsification, and the like ([0029]). Kunio teaches when the raw material is physically made as fine as possible, the entire raw material can be uniformly, accurately, and smoothly processed under a condition of a temperature and a pressure as low as possible and a condition of a time as short as possible, and characteristics as a food raw material without a sense of discomfort in flavor and color can be maintained ([0031]). Kunio teaches since the flowability is enhanced by the grain refinement, there is also an effect that the addition of water to the raw material can be minimized ([0031]).
While Kunio does not teach the precisely claimed weight percent of plant material in the slurry, one of ordinary skill in the art would have adjusted the fineness of the raw material during routine optimization to find the plant material to water ratio in the feed slurry that results in the okara milk with the best flavor and color balanced with the lowest processing requirements. MPEP §2144.05(II) states where 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). The slurry plant material content, 2 – 15 wt%, would thus be obvious.
Regarding claim 5, as evidenced by Liu, when dried, okara contains 40.2 – 43.6 wt% insoluble fiber and 12.6 – 14.6 wt% soluble fiber (p. 457, paragraph 6). According to these proportions, okara comprises 52.8 – 58.2 wt% total fiber, and of this fiber, 73.4 – 77.6 wt% of it is insoluble fiber.
Regarding claim 6, Kunio teaches the okara milk is made from okara.
Regarding claim 9, Kunio teaches a general method of producing okara milk (i.e., a high fiber, phase stable liquid) comprising:
diluting okara with water to form a slurry;
subjecting the slurry to high-pressure homogenization;
subjecting the slurry to high temperatures and pressures;
subjecting the slurry to high-pressure homogenization again (i.e., repeating step (b) – Figure 1, [0011]).
Therefore the modified method of Kunio teaches an embodiment wherein a second high-pressure homogenization (i.e., microfluidization) at 140 MPa is completed, thereby producing okara milk (i.e., a high fiber, phase stable liquid) wherein the high-pressure homogenization (microfluidization) step (b) is repeated at least once.
Regarding claim 10, Kunio teaches a method of producing okara milk (i.e., a high fiber, phase stable liquid) comprising:
diluting okara with water to form a slurry;
subjecting the slurry to high-pressure homogenization;
subjecting the slurry to high temperatures and pressures;
subjecting the slurry to high-pressure homogenization again (i.e., repeating step (b) – Figure 1, [0011]).
The modified method of Kunio teaches the high-pressure homogenization (i.e., microfluidization) can be completed at 5 – 200MPa (50 – 2000 bar – [0033]). Therefore the modified method of Kunio teaches an embodiment wherein a second high-pressure homogenization (i.e., microfluidization) at 5 – 200MPa (50 – 2000 bar) is completed, thereby producing okara milk (i.e., a high fiber, phase stable liquid) wherein the high-pressure homogenization (microfluidization) step (b) is repeated at least once.
The range of homogenization (i.e., microfluidization) pressures, 50 – 2000 bar, as disclosed by Kunio, overlaps with the claimed range of 300 – 800 bar. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 11, the method of claim 1 is directed toward a method of production of the product of claim 11. MPEP § 2113.I teaches even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. Therefore, the structure implied by the process steps of claims 1 have been considered when assessing the patentability of the product.
The structure implied by claim 1 is interpreted to be a homogenized liquid comprising 6 g plant fiber/ 100 ml.
Kunio teaches the shelf life of okara is improved and the insoluble fiber component is softened and pulverized to provide "okara milk" having a smooth flavor by the homogenization method ([0010]). Kunio teaches the okara milk produced by the homogenization process has a high nutritional value and safety ([0010]). The modified method of Kunio teaches the final okara milk comprises 6 g fiber/ 100 ml.
Therefore the modified okara milk of Kunio is encompassed by claim 11.
Regarding claim 22, Kunio does not teach the okara milk (i.e., high fiber, phase stable liquid) has a viscosity of at least 35 mPas.
Elleuch teaches the food industry can take advantage of the physicochemical properties of dietary fiber to improve the viscosity, texture, sensory characteristics and shelf-life of their products (p. 418, paragraph 6). Elleuch teaches the literature contains many reports about additions of dietary fibre to food products such as beverages, dairy, and frozen dairy (p. 418, paragraph 7). Elleuch teaches viscosity, resistance to flow, is defined as the ratio of shear stress to shear rate (p. 416, paragraph 7). Elleuch teaches most polysaccharide solutions exhibit non-Newtonian flow and an increased shear rate can increase or decrease viscosity (p. 416, paragraph 7). Elleuch teaches water soluble fibres are the major component that would increase the viscosity of a solution (p. 416, paragraph 7). Elleuch teaches viscosity increases with an increased fibre concentration but decreases with the temperature of a solution of dietary fibre (p. 417, paragraph 2). Therefore, the fiber content of a beverage is a result-effective variable because increasing the fiber content of a beverage controllably increases its viscosity.
Kunio and Elleuch are combinable because they are concerned with the same field of endeavor, namely, beverages that contain fiber. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have adjusted the amount of fiber in the okara milk during routine optimization to find the final okara milk product with the desired viscosity. MPEP §2144.05(II) states where 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). The claimed viscosity of the high fiber, phase stable liquid, at least 35 mPas, would thus be obvious.
Regarding claim 23, given the okara milk is the product made by the method of Kunio, the okara milk (i.e., the high fiber phase stable liquid) has a volume of 100% v/v in the method.
Claims 7, 8, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kunio (JP 2001204415 A) ) in view of Elleuch et al. (Dietary fibre and fibre-rich by-products of food processing: Characterisation, technological functionality and commercial applications: A review. Food Chemistry. Vol 124. Pp. 411 – 421. (2011), as applied to claim 1 above, and further in view of Lecumberri et al. (Dietary fibre composition, antioxidant capacity and physico-chemical properties of a fibre-rich product from cocoa (Theobroma cacao L.). Food Chemistry. Vol. 104 (2007) pp. 948–954) as evidenced by Liu (14 - Food Use of Whole Soybeans In: Soybeans – Chemistry, Production, Processing, and Utilization. Pp. 441 – 481. (2008)).
Regarding claims 7, 8, and 18, While Kunio does not teach the okara milk is made from plant material from one or more of cocoa shell fiber, Kunio teaches the processing method of the present invention can be applied not only to the processing of bean curd refuse but also to the processing of organic raw materials (pulp, wood flour, cotton, corn kernels, buckwheat husks, wheat bran, sake lees, beer lees, squeezed wine lees, soy sauce lees, bean jam lees, squeezed sugar cane lees, squeezed fruit juice lees such as oranges, apples, and grapes, used tea leaves, meat residue, etc.), however, the present invention is not limited to this ([0045]).
Lecumberri characterizes cocoa shells and identifies potential uses in food products. Lecumberri teaches the total dietary fiber content of cocoa shell is over 60% of the dry matter. Lecumberri teaches the high dietary fiber content of cocoa shell implies that this product might be of interest for the food industry, considering its potential application as a functional ingredient in the preparation of low-fat, high-fibre dietetic products (p. 951, col. 2, paragraph 2). Lecumberri teaches insoluble dietary fiber was the main component of this cocoa product, accounting for over 80% of the total dietary fiber and 50% of the total dry weight (p. 951, col. 2, paragraph 2). Lecumberri teaches the antioxidant capacity of this cocoa fiber and its physico-chemical properties make it a suitable product to be used in the preparation of low calorie, high-fiber foods like dietetic chocolate supplements, etc. where the color and flavor of this cocoa fiber might be advantageous (p. 953, col. 2, paragraph 3).
According to the teachings of Lecumberri, cocoa shells are organic raw materials that have similar fiber compositions to okara and the other listed viable raw materials identified by Kunio. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to apply the method of Kunio to cocoa shell fiber, as suggested by Lecumberri because cocoa shell fiber has a dietary fiber composition similar to okara and has the additional benefits of antioxidant activity and chocolate flavor.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Kunio (JP 2001204415 A) in view of Elleuch et al. (Dietary fibre and fibre-rich by-products of food processing: Characterisation, technological functionality and commercial applications: A review. Food Chemistry. Vol 124. Pp. 411 – 421. (2011), as applied to claim 1 above, and further in view of Lynch et al. (Brewers’ spent grain: a review with an emphasis on food and health. Journal of the Institute of Brewing. Vol 122. Iss 4. Pp. 553 – 568. (2016)), as evidenced by Liu (14 - Food Use of Whole Soybeans In: Soybeans – Chemistry, Production, Processing, and Utilization. Pp. 441 – 481. (2008)).
Regarding claim 20, While Kunio does not teach the okara milk is made from plant material comprising barley spent grain, Kunio teaches the processing method of the present invention can be applied not only to the processing of bean curd refuse but also to the processing of organic raw materials (pulp, wood flour, cotton, corn kernels, buckwheat husks, wheat bran, sake lees, beer lees, squeezed wine lees, soy sauce lees, bean jam lees, squeezed sugar cane lees, squeezed fruit juice lees such as oranges, apples, and grapes, used tea leaves, meat residue, etc.), however, the present invention is not limited to this ([0045]). It is noted that sake lees, beer lees, squeezed wine lees, soy sauce lees, bean jam lees, squeezed sugar cane lees, squeezed fruit juice lees are leftovers from fermentation processes including the making of alcoholic beverages.
Lynch teaches barley spent grain is the leftover malted barley from the beer brewing process. Lynch teaches brewers’ spent grain (i.e., barley spent grain), the insoluble part of the barley grain, is the most abundant by-product generated from the beer-brewing process, representing ~85% of the total by-products obtained (p. 553, Introduction).
Kunio and Lynch are combinable because they are concerned with the same field of endeavor, namely, fermentation leftovers. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to substitute fermentation leftovers taught by Kunio with barley spent grain before the effective filing date of the application because barley spent grain, like the leftovers from brewing alcoholic beverages taught by Kunio, is another type of fermentation leftover from brewing an alcoholic beverages. See MPEP § 2144.06.II.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Kunio (JP 2001204415 A) in view of Elleuch et al. (Dietary fibre and fibre-rich by-products of food processing: Characterisation, technological functionality and commercial applications: A review. Food Chemistry. Vol 124. Pp. 411 – 421. (2011), as applied to claim 1 above, and further in view of Lee et al. (Comparing droplet breakup for a high-pressure valve homogeniser and a Microfluidizer for the potential production of food-grade nanoemulsions. Journal of Food Engineering. Vol 114. Iss 2. Pp. 158 – 163. (2013)) as evidenced by Liu (14 - Food Use of Whole Soybeans In: Soybeans – Chemistry, Production, Processing, and Utilization. Pp. 441 – 481. (2008)).
Regarding claim 21, Kunio does not the homogenization is microfluidization.
Lee compares the high-pressure valve homogenizer to the microfluidizer, two commonly used high-pressure homogenization devices. Lee teaches while increasing pressure results in smaller droplet sizes for both high-pressure valve homogenizers and microfluidizers, the minimum droplet size is achieved in one pass by the microfluidizer at pressures of 100 – 150 MPa, while the high-pressure homogenizer required 5 passes (p. 159, col. 2, paragraph 4). Lee teaches microfluidizers generate similar droplet sizes and distributions regardless of viscosity (p. 160, col. 2, paragraph 2; p. 160, Figure 4). Lee teaches microfluidizers generate similar droplet sizes and distributions regardless of the emulsifier present in a given mixture (p. 161, col. 2, paragraph 2; p. 162, Figure 7).
Kunio and Lee are combinable because they are concerned with the same field of endeavor, namely, homogenization. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have selected microfluidization as the technique for homogenization in step (b) of Kunio, as taught by Lee, because microfluidizers provide a minimum droplet size after the first pass, a narrow droplet size distribution independent of slurry viscosity or emulsifying agent.
Response to Arguments
Applicant's arguments filed April 22, 2026 have been fully considered but they are not persuasive.
Applicant argues Kunio does not teach the okara milk has a fiber content of at least 6 g per 100 ml (p. 5, paragraphs 2 – 4).
Applicant’s argument with respect to the rejections of claims 1, 4 – 6, 9 – 11, and 19 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground of rejection is made in view of Kunio.
Applicant argues Kunio teaches the high pressure and high temperature processing of Kunio significantly decreases the carbohydrate content, including fiber, which is an essential part of the operation of Kunio, and teaches against the presently claimed invention (p. 6, paragraphs 2 – 5).
Applicant’s argument has been carefully considered however the argument is not persuasive. The reduction of carbohydrates by the method of Kunio does not teach away from the precisely claimed amount of fiber in the instant claims. While the method of Kunio produces an okara milk with a lower fiber content than a specifically formulated control, Kunio does not disparage any range of fiber in the final okara product. One of ordinary skill in the art would have understood that adjusting the water content of the okara milk prior to processing via the method of Kunio would allow for the adjustment of fiber content to achieve a desired consistency.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARK JULIA MORENO whose telephone number is (571)272-2337. The examiner can normally be reached 6:30 - 4:30 M - F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Emily Le can be reached at (571) 272-0903. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/L.J.M./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
Prosecution Insights