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 preliminary amendments filed March 9, 2023 and December 15, 2023 has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1, 4 – 11, and 18 – 20
Withdrawn claims: None
Previously cancelled claims: 12 – 17
Newly cancelled claims: 2 and 3
Amended claims: 1, and 4 – 8
New claims: 18 – 20
Claims currently under examination: 1, 4 – 11, and 18 – 20
The status of the objections and rejections regarding the disclosure upon entry of the present amendment stands as follows:
Objections: New objections to new claims 18 – 20 are presented.
35 U.S.C. § 112 Rejections: The previous rejection under 35 U.S.C. § 112(b) of claim 3 is withdrawn due to the cancellation of claim 3. The previous rejection under 35 U.S.C. § 112(b) of claims 6 – 8 is withdrawn in light of applicant’s amendments.
35 U.S.C. § 102 Rejections: The previous rejections under 35 U.S.C. § 102 of claims 1 – 3, 6, 9, and 11 over Kunio are withdrawn in light of Applicant’s arguments. Therefore, this action is NONFINAL.
35 U.S.C. § 103 Rejections: The previous rejections under 35 U.S.C. § 103 of claims 4, 5, 7, 8, and 10 over Kunio are withdrawn in light of Applicant’s arguments. Therefore, this action is NONFINAL. New rejections under 35 U.S.C. § 103 of claims 1, 4 – 11, and 18 – 20 over Kunio are presented below.
Claim Interpretation
Claims 6 – 8 recite “the plant material is from…” which is interpreted broadly to mean any compound that may be naturally present in the recited plant materials, regardless of its original source. While a compound may be obtained from a certain source, in product claims, the compound itself it considered, regardless of how it is made or where it is from. There is no material difference between a given compound obtained by synthesis or extraction from a non-plant source and the same compound that may be naturally present in the recited plant materials.
Claim Objections
Claims 18 – 20 are objected to because of the following informalities:
Claims 18 – 20 recite “wherein the plan material comprises…” which should have the spelling of “plan” corrected to “wherein the plant material comprises…”
Appropriate correction is required.
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, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Kunio (JP 2001204415 A) 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), 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 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.
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 microfluidized liquid comprising plant fiber.
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]).
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 the method 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.
Therefore the modified okara milk of Kunio is encompassed by claim 11.
Claims 7, 8, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kunio (JP 2001204415 A) ) 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 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 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 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.
Response to Arguments
Applicant's arguments filed November 7, 2025 have been fully considered but they are not persuasive.
Applicant argues Kunio teaches the okara slurry is homogenized, but does not disclose or suggest homogenization is, includes, or means microfluidization (p. 6, paragraph 2).
Applicant’s argument with respect to the rejections of claims 1 and 4 – 11 under 35 U.S.C. § 102 and 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’s argument has been carefully considered however the argument is not persuasive.
Conclusion
No claims are allowed.
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.
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/L.J.M./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793