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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on July 6, 2026 has been entered.
Claim Status
The status of the claims upon entry of the present amendments stands as follows:
Pending claims:
1, 6, 7
Withdrawn claims:
None
Previously canceled claims:
2-5
Newly canceled claims:
None
Amended claims:
1
New claims:
None
Claims currently under consideration:
1, 6, 7
Currently rejected claims:
1, 6, 7
Allowed claims:
None
The Examiner notes that claim 1 is designated as “(Previously Presented)”. However, claim 1 has been amended to add “and” prior to the last wherein clause.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Oku (US PGPub 2004/0209841 A1)(IDS Reference filed 02/16/2023) in view of Shimazaki (US PGPub 2005/0249861 A1) and Meng (CN 104085956 B).
Regarding claim 1, Oku teaches a composition comprising a bittern component (Abstract) and that the product can be used for foods including healthy foods and drinks including tofu ([0052]). Oku also teaches that tofu is soybean curd ([0048]). Therefore, it logically follows that the tofu would comprise soybean. Oku also teaches that typical bittern comprises 17.5% w/w magnesium chloride and 8.1% w/w calcium chloride ([0049]), which equates to a proportion of magnesium content to calcium content of 2.16:1, which falls within the claimed range of 2:1 to 7:1.
Oku does not teach the health food comprising 0.8 wt% to 1.5 wt% of bittern, that the bittern is derived from deep-ocean sea water, wherein said bittern per 100g comprises 2500 mg to 6000 mg of magnesium content and 500 mg to 2000 mg of calcium content, or wherein the hardness of said bittern is 144000 mg/L to 383000 mg/L.
Regarding the health food comprising 0.8 wt% to 1.5 wt%, Shimazaki teaches a tofu-like food composition comprising bittern in an amount from 0.01% to 20% by mass (which encompasses the claimed range of 0.8 wt% to 1.5 wt%; [0010]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the food taught by Oku with the use of 0.01% to 20% by mass of bittern as taught by Shimazaki. One of ordinary skill would have been motivated to make this modification because Shimazaki teaches that the bittern serves as a coagulant and that controlling the amount used adjusts the time it takes for the food product to coagulate ([0010]).
With respect to the overlapping ranges, 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 the bittern being derived from deep-ocean sea water, wherein said bittern per 100g comprises 2500 mg to 6000 mg of magnesium content and 500 mg to 2000 mg of calcium content, or wherein the hardness of said bittern is 144000 mg/L to 383000 mg/L, Meng teaches a marine nanofiltration concentrate ([0001]) where the water source is from the deep sea ([0017]). Meng also teaches that the concentrate has a magnesium concentration of 50000-100000 mg/L (equivalent to 5000-10000 mg/100 g, which overlaps with the claimed range of 2500 to 6000 mg/100 g) and a hardness of 355000-425000 mg/L (which overlaps with the claimed range of 144000 to 383000 mg/L; [0039]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the bittern composition used in Oku with the source, magnesium content, and hardness of the concentrate taught by Meng. One of ordinary skill would be motivated to make this modification because, as taught by Meng, the disease with the highest incidence is trace element deficiency or imbalance ([0005]). Therefore, one of ordinary skill would have used the amount of magnesium and the hardness (which is understood in the art to be the measure of mineral ions present) of the composition of Meng to provide a solution that can treat the mineral imbalance. Furthermore, one of ordinary skill would have been motivated to use deep sea water as the source because Meng teaches that deep sea water naturally has a high salt content ([0017]).
With respect to the overlapping ranges, 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.
Although Oku and Meng don’t teach that the amount of calcium in the composition being 500 mg to 2000 mg, Oku teaches that the ratio of magnesium to calcium is 2.16:1 as described above, and Meng teaches the magnesium concentration of 5000 to 10000 mg/100 g as described above. Because Meng does not teach the amount of calcium in the composition, one of ordinary skill would have determined the amount of calcium to include in the bittern composition of Meng. Applying the ratio of Oku to the composition of Meng would result in a calcium content of 2314-4623 mg/100 g, which lies close to the claimed range of 500 mg to 2000 mg.
One of ordinary skill in the art would have found it obvious to modify the composition of Oku with the use of calcium in the amount of 2314-4623 mg/100 g based on the amount of magnesium taught by Meng. One of ordinary skill would be motivated to make this modification because, as taught by Meng, the disease with the highest incidence is trace element deficiency or imbalance ([0005]). Therefore, one of ordinary skill would have used the amount of calcium of the composition of Meng to provide a solution that can treat the mineral imbalance.
With respect to the close range, MPEP §2144.05 states a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985).
Regarding the limitation “wherein the bittern derived from the deep-ocean water increases and activates an Equol producing bacterium after ingestion of the intestinal flora-improving health tofu”, this limitation is interpreted as a necessary property of the bittern derived from the deep-ocean water. MPEP §2112.01(II) states that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the applicant discloses and/or claims are necessarily present.
Regarding claim 6, Oku does not teach that the deep-ocean water is from a depth of at least 200 m or below and does not contain isoflavones.
However, in the same field of endeavor, Meng teaches that the deep ocean water used was obtained from a depth below 200 m ([0017]).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to use the same source of sea water as taught by Meng. One of ordinary skill would have been motivated to use deep sea water as the source because Meng teaches that deep sea water naturally has a high salt content ([0017]).
Although the cited prior art does not teach that the deep ocean water does not contain isoflavones, Meng is silent regarding the presence of isoflavones in ocean water. Thus, one of ordinary skill would have found it obvious to use ocean water that does not comprise isoflavones.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Oku (US PGPub 2004/0209841 A1)(IDS Reference filed 02/16/2023) in view of Shimazaki (US PGPub 2005/0249861 A1) and Meng (CN 104085956 B) as applied to claim 1 above, and further in view of Chen (CN103315285B).
Regarding claim 7, the cited prior art does not teach wherein the hardness of the bittern is 144000 mg/L to 242473 mg/L.
However, in the same field of endeavor of deep-sea mineral concentrates (i.e., bittern), Chen teaches a deep-sea concentrated mineral solution (i.e., bittern) with a hardness of 160000 to 190000 mg/L ([0055]), which falls within the claimed range of 144000 mg/L to 242473 mg/L.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the product of Oku with the mineral hardness taught by Chen. The claim would have been obvious because all claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective function, and the combination yielded nothing more than predictable results to one of ordinary skill in the art, see MPEP §2143(A).
Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claims 1 and 6 over Oku, Shimazaki, and Meng: Applicant’s arguments filed July 6, 2026 have been fully considered but they are not persuasive.
Applicant argued that the water of the claimed invention is obtained from Cape Muroto made with a system that employs a salt-production method for obtaining salt close to natural salt (Remarks, p. 5, ¶ 1- p. 6, ¶ 3).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the specific location of the deep-ocean water and salt-production method) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Regardless, the Applicant has not provided data to demonstrate a patentable difference between the deep ocean water obtained from Cape Muroto and from that of water obtained from the same depth at a different location.
Applicant also argued that the invention of Oku differs in purpose from the claimed invention. Applicant further argues that the invention of Oku requires trehalose or maltitol, which are not claimed (Remarks, p. 7, ¶ 1-6).
This argument has been considered. Although the intended use of Oku differs from that of the claimed invention, MPEP §2112.01 states where the claimed and prior art are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Thus, the portions of Oku that are relied upon to teach the claimed invention are considered sufficient.
With respect to Applicant’s argument that trehalose and maltitol are not claimed, claim 1 uses the transition phrase “comprising”. MPEP 2111.03(I) states “The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps.” Thus, the composition of claim 1 does not preclude the addition of trehalose and maltitol.
Applicant further argued that Oku merely describes general bittern, not bittern derived from deep-ocean water (Remarks, p. 8, ¶ 1).
This argument has been considered. However, Oku is not relied upon to teach the source of the bittern. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains that Oku is adequate for all that is relied on in the present claim rejections, and the combination of references is adequate to deem the present claims obvious.
Applicant also argued that Shimazaki does not provide what Oku lacks and that Shimazaki has a different intended purpose than the claimed invention (Remarks, p. 8, ¶ 3- p. 9, ¶ 3).
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains that Shimazaki is adequate for all that is relied on in the present claim rejections, and the combination of references is adequate to deem the present claims obvious. Furthermore, although the intended use of Shimazaki differs from that of the claimed invention, MPEP §2112.01 states where the claimed and prior art are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Thus, the portions of Shimazaki that are relied upon to teach the claimed invention are considered sufficient.
With respect to Applicant’s argument that claim 1 would not have been obvious because the combination of Shimazaki and Oku does not teach all limitations of claim 1, claim 1 is not rejected using only Oku and Shimazaki. Claim 1 also relies upon the disclosure of Meng to teach all limitations of the claimed invention. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). A proper 35 USC 103 rejection over Oku in view of Shimazaki and Meng has been provided in the rejection of claim 1 above.
Applicant further argued that Meng does not provide for what Oku and Shimazaki lack (Remarks, p. 9, ¶ 4).
One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains that Meng is adequate for all that is relied on in the present claim rejections, and the combination of references is adequate to deem the present claims obvious.
Applicant further argued that Meng utilizes a ceramic membrane whereas the claimed invention is made with reverse osmosis (Remarks, p. 10, ¶ 1).
This argument has been considered. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., reverse osmosis to produce the bittern) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant further argued that Meng does not suggest using deep-ocean water (Remarks, p. 10, ¶ 2).
This argument has been considered. However, Meng teaches that deep sea water naturally has a high salt content ([0017]). Thus, the Examiner maintains that one of ordinary skill would have been motivated to use deep sea water as the source of the sea water.
Applicant argues that the combination of Oku, Shimazaki, and Meng would not teach or suggest wherein the bittern increases and activates an Equol producing bacterium after ingestion (Remarks, p. 10, ¶ 4).
This argument has been considered. However, the Examiner maintains that this limitation is interpreted as a necessary property of the bittern derived from the deep-ocean water. MPEP §2112.01(II) states that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the applicant discloses and/or claims are necessarily present. The Applicant has not provided data to demonstrate that the product of the cited prior art would lack this feature.
Claim Rejections – 35 U.S.C. §103 of claims 1 and 6 over Oku, Shimazaki, Meng, and Chen: Applicant’s arguments filed July 6, 2026 have been fully considered but they are not persuasive.
Applicant argued the Chen does not provide what Oku, Shimazaki, and Meng lack (Remarks, p. 11, ¶ 2).
This argument has been considered. One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Examiner maintains that Chen is adequate for all that is relied on in the present claim rejections, and the combination of references is adequate to deem the present claims obvious.
Applicant argued that Chen has a different intended use than the claimed invention (Remarks, p. 11, ¶ 3)
This argument has been considered. However, MPEP §2112.01 states where the claimed and prior art are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Thus, the portions of Chen that are relied upon to teach the claimed invention are considered sufficient.
Applicant also argued that Chen does not describe processing the deep ocean bittern with reverse osmosis (Remarks, p. 11, ¶ 4).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., reverse osmosis to produce the bittern) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues that the combination of Oku, Shimazaki, Meng, and Chen would not teach or suggest wherein the bittern increases and activates an Equol producing bacterium after ingestion (Remarks, p. 10, ¶ 4).
This argument has been considered. However, the Examiner maintains that this limitation is interpreted as a necessary property of the bittern derived from the deep-ocean water. MPEP §2112.01(II) states that a chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the applicant discloses and/or claims are necessarily present. The Applicant has not provided data to demonstrate that the product of the cited prior art would lack this feature. Additionally, Chen is not relied upon for the rejection of claim 1.
Declaration under 37 C.F.R. 1.132: The declaration under 37 CFR §1.132 filed July 6, 2026 (hereinafter “Declaration”) is insufficient to overcome the rejection of the claims based upon Oku, Shimazaki, and Meng as set forth in the office action.
MPEP §716.01(c)(III) states “In assessing the probative value of an expert opinion, the examiner must consider:
The nature of the matter sought to be established,
The strength of any opposing evidence,
The interest of the expert in the outcome of the case, and
The presence or absence of factual support for the expert’s opinion.”
Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 227 USPQ 657 (Fed. Cir. 1985), cert. denied, 475 U.S. 1017 (1986)
The Declaration seeks to establish that a tofu product using nigari (i.e., bittern) from Muroto deep seawater improves the human intestinal environment as compared with commercially available tofu (Declaration, p. 1, ¶ 6-7).
Regarding the strength of the opposing evidence, the evidence is insufficient to demonstrate unexpected results of the claimed invention. The data provided by the exhibit is not commensurate in scope with the claimed invention. Claim 1 does not recite that the bittern is obtained from water that is collected from Cape Muroto. Additionally, MPEP §716.02(d) states that “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)” and “To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).”
Additionally, Exhibit 1 described a study investigating the difference between a tofu with isoflavones and a placebo tofu without soy isoflavones (p. 2, col. 1, ¶ 2). Exhibit 1 does not explicitly disclose that the placebo tofu does not contain a bittern. Regardless, even if the placebo were to be a tofu without the deep-water bittern, the exhibit does not provide data sufficient to overcome the rejection of the claimed invention. The cited prior art provides a tofu-based food that contains a bittern. To overcome the current rejection, evidence is needed to show that the composition of the prior art is patentably different from that of the claimed invention.
Thus, the strength of the opposing evidence is not sufficient to overcome the rejection of the claims over Oku, Shimazaki, and Meng.
Regarding the interest of the expert in the outcome of the case, the Declaration is submitted by Hiroki Takeuchi, who is considered an interested party in the outcome of the case. An affidavit of an applicant as to the advantages of their claimed invention, while less persuasive than that of a disinterested person, cannot be disregarded for this reason alone. Ex parte Keyes, 214 USPQ 579 (Bd. App. 1982); In re McKenna, 203 F.2d 717, 97 USPQ 348 (CCPA 1953).
Regarding the presence or absence of factual support for the expert’s opinion, it has been found that the statement is unsupported by the provided evidence. Exhibit 1 described a study investigating the difference between a tofu with isoflavones and a placebo tofu without soy isoflavones (p. 2, col. 1, ¶ 2). Exhibit 1 does not explicitly disclose that the placebo tofu does not contain a bittern. Regardless, even if the placebo were to be a tofu without the deep-water bittern, the exhibit does not provide data sufficient to overcome the rejection of the claimed invention. The cited prior art provides a tofu-based food that contains a bittern. To overcome the current rejection, evidence is needed to show that the composition of the prior art is patentably different from that of the claimed invention. Additionally, claim 1 does not recite that the bittern is obtained from water that is collected from Cape Muroto.
The rejections of claims 1, 6, and 7 have been maintained herein.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 Amanda S Hawkins whose telephone number is (703)756-1530. The examiner can normally be reached M-Th 8:00a-4:00p, F 8:00a-1:00p ET.
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/A.S.H./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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