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 .
DETAILED ACTION
The Amendments filed on Aug. 27, 2025 has been received and entered.
Claims 1-5, 7-10, and 13-23 are pending. Claims 1-4, 7-9, 13-15, and 21-23 are examined on the merits. Claims 5, 10, and 6-19 are withdrawn.
Response to Amendment
Election/Restrictions
Claims 5, 10, 16-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on Jan. 23, 2025.
Applicant's election with traverse of Group I (Claims 1-5, 7-10), the species cyanidin-3-glucoside, lysine, bilberries in the reply filed on Jan. 23, 2025 is acknowledged. The traversal is on the ground(s) that there is no burden to search all the species and groups. This is not found persuasive because a search of one group is not coextensive with the search of the other groups. Thus, it would be burdensome to search the entire claims.
The requirement is still deemed proper and is therefore made FINAL.
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(s) 21 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bjork et al. (2016, Nutrition & Metabolism, 13:4). This is a new rejection.
Bjork et al. teaches a composition comprising 0.5 microM DHA and AC, that is 130 nM cyanidin-3-glucoside (Fig. 1). The optional ingredients are not examined.
The range of 40-55 wt% DHA relative to total amino acid salt weight is not considered because the optional components are not examined.
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.
Claim(s) 1-4, 7-9, 13-15, 20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Gottstein et al. (from IDS, WO 20190346098 A1) as evident by Sakuma (JP 2016073296 A), and further in view of Yo (JP 2018140956 A). This is a new rejection.
Gottstein et al. teaches a composition containing omega-3 fatty acid amino acid salts, where omega-3 fatty acid is selected from eicosapentaenoic acid and docosahexaenoic acid, amino acid salt is preferably lysine (Claims 1-7). The composition further comprises additional active ingredients from anthocyanins (Claim 8). Anthocyanins inherently contains cyanidin-3-glucoside, which accounts for about 80% of the total anthocyanins (see Sakuma, Description, paragraph 3).
The combination of Gottstein et al. and Sakuma do not specifically teach the bilberries, weight ratio of polyunsaturated fatty acid to anthocyanin ranges from 1:1 to 1:6.
Yo teaches bilberry extract is a source for anthocyanins (page 3, paragraph 2).
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.).
It would have been obvious to one of ordinary skill in the art at the time the claimed invention was made to combine the instant ingredients for their known benefit since each is well known in the art for more source of anthocyanin. This rejection is based on the well-established proposition of patent law that no invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients, In re Sussman, 136 F.2d 715, 718, 58 USPQ 262, 264 (CCPA 1943). Accordingly, the instant claims, in the range of proportions where no unexpected results are observed, would have been obvious to one of ordinary skill having the above cited references before him.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation.103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions…
…the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) emphasis added.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising weight ratio of polyunsaturated fatty acid to anthocyanin ranges from 1:1 to 1:6 of the active agent combination for the following reasons. The reference does teach the composition for supplement. Gottstein et al. teaches a composition containing omega-3 fatty acid amino acid salts, where omega-3 fatty acid is selected from eicosapentaenoic acid and docosahexaenoic acid, amino acid salt is preferably lysine (Claims 1-7). The composition further comprises additional active ingredients from anthocyanins (Claim 8). Thus, it would have been obvious to make a concentrated composition containing polyunsaturated fatty acid and anthocyanin for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here 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). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Response to Amendment
Applicant argues that cyanidin-3-glucoside is not taught.
In response to Applicant’s argument, cyanidin-3-glucoside is a prevalent form of anthocyanin. The reference teaches that fact. As long as the reference teaches the claim then the reference can be used to support the claim as inherent characteristic.
Applicant argues that the amounts are not obvious to use.
In response to Applicant’s argument, the amounts of DHA and EPA are known in the arts for what amounts to use because the DHA and EPA have known solubility for crossing over the blood plasma that is tolerated by the subject. The amounts would be known in the art and the amount optimized to be safely used in a subject seeking nutrient supplements would be obvious to use.
Conclusion
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.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655