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 .
Status of claims
Claims 1, 9, 11 and 12 as amended on 6/25/2026 are pending and under examination.
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.
Claim 1 as amended remain/is rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Umeki et al (“Effect of the Dried-Bonito Broth on Blood Pressure, 8-Hydroxydeoxyguanosine (8-OHdG), an Oxidative Stress Marker, and Emotional States in Elderly Subjects”. J. Clin. Biochem. Nutr., November 2008, 43, pages 175-184).
The cited reference by Umeki teaches that administration of bonito-base food/broth to elderly subjects lowered blood pressure, reduced 8-OHdG lever, which is an oxidative stress marker and improved mood (see abstract).
The cited reference by Umeki discloses a food product comprising a dried bonito broth (DDB, katsuo-bushi dashi) or bonito-derived extract that is made by water extraction of dried bonito preparation (see page 177, col. 1, section test samples”; see page 176, col. 2, lines 7-8). The reference teaches that bonito-based food or broth is a traditional remedy for recovery from fatigues and improvement in blood circulation.
Thus, the cited method of Umeki is considered to be identical to the claimed method because the cited method comprises one identical active step of administering identical composition to identical subject as in the claimed method.
Thus, the cited reference by Umeki anticipates the claimed invention.
Claims 1 and 9 as amended remain/are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Umeki et al (“Effect of the Dried-Bonito Broth on Blood Pressure, 8-Hydroxydeoxyguanosine (8-OHdG), an Oxidative Stress Marker, and Emotional States in Elderly Subjects”. J. Clin. Biochem. Nutr., November 2008, 43, pages 175-184) in the light of evidence by US 11,856,973 (Okada).
The cited reference by Umeki teaches that administration of bonito-base food/broth to elderly subjects lowered blood pressure, reduced 8-OHdG level, which is an oxidative stress marker, and improved mood (see abstract).
In the method of the cited reference by the food with bonito-derived extract (katsuo-bushi dashi) is provided in a form of a broth (abstract) and made by water extraction of dried bonito preparation (see page 177, col. 1, section test samples”; see page 176, col. 2, lines 7-8). Although the cited reference by Umeki is silent about presence of histidine and inosinic acid in bonito-based food, it is well knonw that presence of histidine and of inosinic acid is an inherent characteristic of bonito-based food; for example: see by US 11,856,973 (Okada) at abstract and at col. 8, table 2.
Thus, the cited method is considered to be identical to the claimed method because the cited method comprises one identical active step of administering identical composition to identical subject as the claimed method.
Thus, the cited reference by Umeki anticipates the claimed invention in the light of evidence by US 11,856,973 (Okada).
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.
Claim 1 as amended is rejected under 35 U.S.C. 103 as being unpatentable over by Umeki et al (“Effect of the Dried-Bonito Broth on Blood Pressure, 8-Hydroxydeoxyguanosine (8-OHdG), an Oxidative Stress Marker, and Emotional States in Elderly Subjects”. J. Clin. Biochem. Nutr., November 2008, 43, pages 175-184) in view of Buttler et al (Frontiers in Physiology. 2017, Vol. 8, article 1048, pages 1-14) and Lehner et al (Antioxidants and Redox Signaling. 2011, Vol. 15, No. 5, pages 1305-1323).
The cited reference by Umeki teaches that administration of bonito-base food/broth to elderly subjects lowered blood pressure, reduced 8-OHdG lever, which is an oxidative stress marker and improved mood (see abstract). Although the cited reference by Umeki does not explicitly acknowledge a correlation between hypertension and oxidative stress with blood-brain barrier (BBB) function, it is knonw in the prior art that hypertension is accompanied by BBB dysfunction (see abstract of Buttler et al) and that BBB disruption is induced by oxidative stress (see abstract of Lehner et al).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to administer a bonito-derived extract preparations to elderly subjects who commonly have hypertension and susceptible to oxidative stress with a reasonable expectation of success in improving their blood-brain function because hypertension and oxidative stress are linked to BBB function.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claims 1, 9 11 and 12 as amended are rejected under 35 U.S.C. 103 as being unpatentable over Umeki et al (“Effect of the Dried-Bonito Broth on Blood Pressure, 8-Hydroxydeoxyguanosine (8-OHdG), an Oxidative Stress Marker, and Emotional States in Elderly Subjects”. J. Clin. Biochem. Nutr., November 2008, 43, pages 175-184) in view of Buttler et al (Frontiers in Physiology. 2017, Vol. 8, article 1048, pages 1-14) and Lehner et al (Antioxidants and Redox Signaling. 2011, Vol. 15, No. 5, pages 1305-1323) as applied to claim 1 above, and further in view of US 11,856,973 (Okada) and US 4,981,699 (Inada et al).
The cited reference by Umeki in view of Buttler and Lehner is relied upon as explained above for the disclosure of a method for improving blood barrier function by administering a bonito-derived extract preparations to elderly subjects who commonly have hypertension and susceptible to oxidative stress, and thus, in need in improving their blood-brain function because hypertension and oxidative stress are linked to BBB dysfunction.
With regard to the therapeutic bonito-based product in the method of Umeki, it is well knonw that the bonito-based food/broth contain and/or are rich in histidine and inosinic acid as evidenced by US 11,856,973 (Okada); for example: see abstract and see col. 8, table 2.
In particular, the bonito extract based broth of the method of cited reference by Umeki contains 50 parts of dried bonito extract preparation for 50 parts of water (page 177, col. 1, section test samples”); and, thus, appears to contain more than claimed 0.1 mg/ml. However, prior art US 4,981,699 (Inada) teaches that edible materials including bonito-based preparation or katsuo-bushi (see col. 5, line 44; see col. 9, lines 30-31 and lines 41-45, see table 4) are provided as a concentrate and as an aqueous extract/dilution or as broth (col. 5, lines 64-68). Although a bonito-derived extract or broth commonly contains 1% (10mg/ml) of bonito-derived extract preparation (see preparation A in table 4), a concentrated preparation of edible materials including katsuo-bushi contains 0.0001% to 50% by weigh of the total edible composition (col. 6, lines 5-7).
Therefore, it would have been obvious to one having ordinary skill in the art at the time the claimed invention was filed to modify/optimize amounts of bonito-derived extract preparations together with their major components such as inosinic acid and histidine in the method of Umeki within the prior art recognized ranges with a reasonable expectation of success in providing beneficial nutrition and health foods as intended for improving fatigue, blood circulation and lowering blood and susceptibility to oxidative stress in elderly subjects who would benefit in improving their BBB function. For one of ordinary practitioners it would obvious to optimize and/or to reduce amounts of bonito in food and/or therapeutics in order to decrease saltiness and/or unpleasant umami flavor for an unprepared western palette.
Thus, the claimed invention as a whole was clearly prima facie obvious, especially in the absence of evidence to the contrary.
The claimed subject matter fails to patentably distinguish over the state art as represented be the cited references. Therefore, the claims are properly rejected under 35 USC § 103.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 9, 10 and 11 as amended remain/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon without significantly more.
The claims recite a method of administering a composition comprising bonito extract to a subject. The subject under administration is generic. Bonito is a fish (see the cited reference by Umeki); and aqueous food preparation, which is a bonito extract, is a natural product.
Further, the bonito or bonito extract contain and are rich in histidine and inosinic acid as evidenced by US 11,856,973 (Okada); for example: see abstract and see col. 8, table 2). The specific amounts of bonito and its major ingredients in aqueous forms are common characteristics depending on amount of water. Thus, dilution with water does not materially and structurally changes and/or does not transform natural and basic characteristics of either bonito-based water dilution, nor histidine and nor inosinic acid. Thus, the final product is a mixture of all natural ingredients that are not markedly different from the product' s naturally occurring counterpart in its natural state.
Therefore, the claimed invention as a whole is drawn to providing a nature-based food to generic or unlimited population of people, thereby, it is an act of mere eating or a natural phenomenon.
This judicial exception is not integrated into a practical application because it is nothing more than an attempt to generally link the product of nature to a particular technological environment. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements (claim-recited bonito, bonito extract, histidine, inosinic acid, amounts) when considered separately and in combination, they do not add significantly more (also known as an “inventive concept”) to the exception.
Response to Arguments
Applicant’s arguments filed on 6/26/2026 with respect to claims as now amended have been considered but are moot because of the new grounds of rejections necessitated by the current amendment which is switching the originally presently scope of claims from a product to a method of using the product.
Some of the arguments are drawn the idea that subjects as disclosed in the reference by Umeki have not been tested for specific parameters of BBB state. Yet, the claims do not recite what is a diagnosis or a physiological state a subject provided with bonito food.
Conclusion
THIS ACTION IS MADE FINAL. 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 VERA AFREMOVA whose telephone number is (571)272-0914. The examiner can normally be reached Monday-Friday: 8.30am-5pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Vera Afremova
August 24, 2026
/VERA AFREMOVA/ Primary Examiner, Art Unit 1653
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