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 .
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-11, 17 and 18, drawn to high-density nutritional composition, classified in A23J 3/14.
II. Claims 12-16, drawn to nutritional composition, classified in A61K 36/45.
III . Claims 19 and 20, drawn to meal replacement or snack, classified in A23L 7/126.
IV. Claims 21 and 22, drawn to beverage, classified in A61K 9/0095.
V. Claim 23 and 24, drawn to a method of improving vascular health, classified in A61P 9/14.
VI. Claim 25, drawn to method improving cognitive function, classified in A61P 25/18.
The inventions are independent or distinct, each from the other because:
Inventions I and II are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the high-density composition reads on roasted edamame and chia bran which has high protein and fiber. The subcombination has separate utility such as a supplement for weight loss by adding green tea extract.
Inventions I and III are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the high-density composition reads on roasted edamame and chia bran. The subcombination has separate utility such as a meal replacement.
Inventions I and III are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the the high-density composition reads on roasted edamame and chia bran. The subcombination has separate utility such as a meal replacement or snack.
Inventions I and IV are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the high-density composition has use as a nutritional supplement for increasing fiber and protein. The subcombination has separate utility such as a beverage.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Inventions I and V-VI are related as product and process of use. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the high density nutritional composition can be used in a materially different process such as a method of improving weight loss.
Inventions II and III-IV are directed to related high-density nutritional compositions. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have materially different designs because the nutritional combination encompasses nutritional supplement powders with antioxidant boosters whereas Groups III and IV are drawn to meal replacements, snacks and beverages which do not require an antioxidant booster. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Inventions II and V-VI are unrelated. Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06). In the instant case, the different inventions are that Group II is drawn to a nutritional combination additionally comprising an antioxidant booster whereas the methods do not require an antioxidant booster and combination can be used in a materially different methods, such as methods of improving weight loss.
Inventions III and V-VI are unrelated. Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06). In the instant case, the different inventions are that Group III is drawn to a meal replacement or snack optionally comprising an antioxidant booster whereas the methods do not require a meal replacement or snack form and can be used in a materially different methods, such as methods of improving weight loss.
Inventions IV and V-VI are unrelated. Inventions are unrelated if it can be shown that they are not disclosed as capable of use together and they have different designs, modes of operation, and effects (MPEP § 802.01 and § 806.06). In the instant case, the different inventions are that Group IV is drawn to a beverage optionally comprising an antioxidant booster whereas the methods do not require an antioxidant booster and combination can be used in a materially different methods, such as methods of improving weight loss.
Inventions V and VI are directed to related methods of using the high-density nutrition compositions. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed have different designs since group V is drawn to improving vascular health, whereas Group VI is drawn to improving cognitive function. Therefore, the inventions do not overlap in scope because the treatments are directed to treating different systems in the body. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
The groupings are classified differently and require different fields of search which adds additional search burden.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
This application contains claims directed to the following patentably distinct species an antioxidant booster selected from bilberry, green tea extract, isoquercetin, echinacea, vitamin C, zinc, berberine, ginger, cinnamon, black garlic, bergamont, flax seeds and turmeric. The species are independent or distinct because they have different properties and contain different compounds. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, 1-25 are generic.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply: The species include foods, vitamins, spices and seeds which have different properties and contain different compounds. Therefore, there is search burden to search all species.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Alice Carroll on 10/30/2025 a provisional election was made without traverse to prosecute the invention of Group II with the species found in the group of claim 13 which comprises bilberry as drawn to claims 12 and 13. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-11 and 14-25 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/7/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claim 12 is objected to because of the following informalities: Claim 12 is objected to for depending on withdrawn claim 1. Claim 12 should be amended to include the limitations of claim 1. 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.
Claim(s) 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (US 2003/0104108; published June 5, 2003) in view of Kendrick (US 2007/0218170, published September 20, 2007), Yajima et al. (US 2007/207187; published September 6, 2007) and Pires et al. (Development of new bilberry based snacks: Nutritional, chemical and bioactive features (Food Chemistry 334, 2021).
Applicant claims a nutritional composition comprising a composition in a serving size of from about 25-60g comprising 5-35 grams protein, 50-200 mg polyphenol, 2.5-24 grams fiber, 0-6 grams vitamins and minerals, 1-15 grams carbohydrates and 0-6 grams fat, wherein the ratio of nutrients to carbohydrate and fat exceed 1.5:1 on a dry weight basis and an antioxidant booster comprising bilberry, green tea, isoquercetin, echinacea, vitamin C and zinc.
Patel et al. teach ready-to-drink soy beverages comprising soy, fruit and vegetable juices (abstract). Table 1 teaches a known soy protein containing isoflavones, wherein GeniSoy comprises 14 grams protein, 0 grams of fat and 14-70 mg isoflavone (polyphenol) in a 35 gram serving and wherein Health Source comprises 20 grams protein, 1 gram fat and 55 mg isoflavones (polyphenol) in a 29 gram serving [0009]. The soy protein is selected from soy flakes, protein isolate, soy flour, soy protein fiber, soy whey and mixtures thereof [0037]. The beverages are fortified with one or more vitamins selected from vitamin C and additional minerals include zinc [0040]. The soybeans are processed by extracting the oil and leaving the defatted soybean flakes comprising protein, fiber, whey, protein isolate, protein concentrate and flour [0058-59]. The second component is a source of carbohydrates selected from fruit juice concentrates including blueberry [0065].
Patel et al. teaches soy fiber and various fruit juices but does not specify 2.5-24 grams fiber and an antioxidant booster comprising bilberry, green tea, isoquercetin and echinacea. It is for this reason that Kendrick, Yajima et al. and Pires et al. are joined.
Kendrick teach alkaline soluble fiber compositions preferably comprising inulin (abstract). Increasing dietary intake of soluble fiber is desirable because it lowers blood cholesterol, moderates blood glucose levels, assists in weight management, and reduces risk of developing certain cancers [0005]. The beverage compositions of comprise soluble fiber sources from soluble soy fiber [0037]. Soy fiber provides and excellent source of fiber, about 15% by weight because it acts as a prebiotic and lowers LDL and triglycerides [0043]. Increasing dietary fiber intake from 10 gram per day to 25-30 grams is shown to improve health [0054]. The compositions provide from 0-60 grams of soluble fiber [0055]. The compositions also include green tea which is rich in polyphenols and EGCG an extremely powerful antioxidant which prevents cancer, inflammation and infection [0092]. Formulations may also include bilberry extract which facilitates eye health, strengthens capillaries and veins and alleviates digestive issues [0093].
Yajima et al. teach food compositions comprising whey protein, green tea and blueberry (abstract). Additional immunostimulatory substances included in the formulations include vitamin C, zinc, echinacea and polyphenols [0088]. The green tea powder improves flavor and improves color of the protein to improve palatability [0265].
Pires et al. teach nutritional food products comprising bilberry (abstract). Bilberry is also known as European blueberry and have been linked to their antioxidant potential due to high levels of anthocyanins associated with antimicrobial, anti-inflammatory and anti-mutagenic properties and treating type 2 diabetes and cardiovascular diseases (page 1). The bilberries art taught to inherently comprise quercetin-3-O-glucoside (isoquercetin) (page 6, section 3.2). Therefore, the findings support the interest of formulating bilberry-based snacks supplemented with edible petals or fruits (page 9).
Patel, Kendrick, Yajima et al. and Pires et al. are all drawn to food products. Therefore, it would have been prima facie obvious to combine the teachings of Patel, Kendrick, Yajima et al. and Pires et al. to include 2.5-24 grams fiber with a reasonable expectation of success. One of ordinary skill would have been motivated before the time of filing to combine the teachings of Patel, Kendrick, Yajima et al. and Pires et al. to include 2.5-24 grams of fiber because Kendrick teaches soy fiber provides an excellent source of fiber, acts as a prebiotic and lowers LDL and triglycerides and increasing dietary fiber intake from 10 gram per day to 25-30 grams wherein the compositions provide from 0-60 grams of soluble fiber.
It would have been prima facie obvious to combine the teachings of Patel, Kendrick, Yajima et al. and Pires et al. to include bilberry and isoquercetin with a reasonable expectation of success. One of ordinary skill would have been motivated before the time of filing to combine the teachings of Patel, Kendrick, Yajima et al. and Pires et al. to include bilberry as an antioxidant booster because Kendrick teaches that bilberry facilitates eye health, strengthens capillaries and veins and alleviates digestive issues and Pires et al. teach bilberry is also known as European blueberry and inherently comprise quercetin-3-O-glucoside (isoquercetin).
It would have been prima facie obvious to combine the teachings of Patel, Kendrick, Yajima et al. and Pires et al. to include green tea with a reasonable expectation of success. One of ordinary skill would have been motivated before the time of filing to combine the teachings of Patel, Kendrick, Yajima et al. and Pires et al. to include green tea because Kendrick teaches extremely powerful antioxidant which prevents cancer, inflammation and infection and Yajima et al. green tea also improve palatability.
Finally, it would have been prima facie obvious to combine the teachings of Patel, Kendrick, Yajima et al. and Pires et al. to include echinacea with a reasonable expectation of success. One of ordinary skill would have been motivated before the time of filing to combine the teachings of Patel, Kendrick, Yajima et al. and Pires et al. to include echinacea because Yajima et al. teach immunostimulatory substances included in the formulations include vitamin C, zinc, echinacea and polyphenols. Therefore, adding echinacea to a formulation comprising vitamin C and zinc would have been prima facie obvious.
Conclusion
No claims allowed.
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DANIELLE D. JOHNSON
Examiner
Art Unit 1617
/BETHANY P BARHAM/ Supervisory Patent Examiner, Art Unit 1611