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
Response to Amendment
As a result of the amendments to the Claim, the Objection over Claim 6 has been withdrawn.
Also, the 112(b) rejection over claims 1, 3-5 and 16 have been withdrawn.
All rejections not repeated in this Office Action have been withdrawn.
Claims 1, 3-20 are currently pending in this Office Action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 15, “use” claims without setting forth any steps involved renders the claim indefinite because it merely recites a use without any active, positive steps delimited how this use is actually practiced. See MPEP 2173.05(q).
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, 10-13, 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Holtey (WO 2017/220220 A1- see translations) in view of Fukuda (US 2010/0209585 A1- cited in IDS filed 7/7/2023), Meydani et al. (WO 2019/236947 A1) and evidenced by Mohamed et al. (NPL Reference- Impacts of turmeric and its principal bioactive curcumin on human health: Pharmaceutical, medicinal, and food applications: A comprehensive review.)
Regarding Claim 1, Holtey discloses a powder composition (The dietary supplement according to the invention is preferably present as a powder, page 9, 11th paragraph) for the preparation of a solution for oral administration (dissolved in a glass of water, page 11, second paragraph of Example 2), wherein the composition contains, per 100 g,
at least 50 g of at least one monosaccharide (fructose, at least 50wt%, paragraph 29, page 5),
at least one steviol glycoside (stevioside, paragraph 29, page 5)
citric acid (paragraph 33, page 5),
1.067g vitamin C (page 6, lines 18-19),
at least two other vitamins (B2 and E, page 6, lines 5-7),
an extract from green tea (Page 6, line 8),
0.010 (or 10mg) to 5g an extract from ginger (seen as 0.010 to 5.000 wt%, Page 4, third to last paragraph and page 5, first paragraph).
Holtey is silent to a microbially stable composition comprising:
4 mg to 200 mg of an extract from pepper (Piper nigrum),
0.25 mg to 2 g of a curcumin compound,
and the amounts of:
0.18 g to 0.70 g of the at least one steviol glycoside
1.5 g to 10 g citric acid
and wherein the green tea extract is Camellia sinensis and the ginger is Zingiber officinale.
Fukuda is relied on to teach an instant powder drink (see title and abstract), comprising 0.01 to 10.0wt% of a hydroxycarboxylic acid such as citric acid (see paragraphs 46-47). The combination of ascorbic acid and citric acid is preferred from the viewpoint of adequate sourness, and in general, preferred for its pH adjustment and oxidation-preventing effects (paragraph 46). Therefore, since Holtey is also directed to a beverage drink powder comprising ascorbic acid (vitamin c) and citric acid, it would have been obvious to one of ordinary skill in the art to use 0.01% to 10.0wt% citric acid based on the desired level of sourness. The oxidation-preventing effects imparted by the combination of acid is construed to provide at least some degree of microbial stability.
Fukuda is also relied on to further teach a powder ink comprising green tea extract derived from Camellia sinensis (paragraph 50). Therefore, since both Fukuda and Holtey are directed to beverage powders comprising green tea extract, it would have been obvious to one of ordinary skill in the art to use tea leaves from Camellia sinensis based on product choice and/or taste preference. Furthermore, it would have been obvious to substitute equivalents known for the same purpose (See MPEP 2144.06).
Fukuda is also relied on to teach a beverage powder comprising an herb extract such as turmeric (paragraph 66) in an amount of 1% to 10.0wt% of the composition to improve its taste and health-related functions. As evidenced by the Mohamed reference, turmeric contains about 3% to 8% curcumin (Page 2, second to last paragraph). Therefore, a composition comprising 1% to 10wt% turmeric would be expected to comprise 0.03% up to 0.80% curcumin, or 30mg to 800mg per 100g basis. For similar reasons discussed above, it would have been obvious to one of ordinary skill in the art to further comprise 1% to 10.0wt% turmeric, which comprises curcumin, for the purpose of imparting a desired taste and health-related function.
Fukuda is also relied on to teach a beverage powder comprising a natural sweetener, in addition comprising carbohydrates such as fructose (paragraph 62). The natural sweetener may comprise stevioside, which is a steviol glycoside, in an amount of 0.001 to 1wt% (paragraph 62). Since both Fukuda and Holtey are directed to beverage powder comprising similar amounts of carbohydrates (fructose in an amount of 60 to 95wt%, paragraph 58), it would have been obvious to one of ordinary skill in the art to further comprise a natural sweetener such as stevioside in an amount of 0.001 to 1.0wt% based on taste preference.
Meydani is relied on to teach a beverage powder composition (dry powder of fruits and vegetables, see abstract), comprising pepper from piper nigrum as a food flavoring (Page 16, line 23-Page 18, line 13). Meydani also discloses ginger extract from Zingiber officinale (page 17, first paragraph). Since Meydani is directed to a drink powder, it would have been obvious to one of ordinary skill in the art to further comprise piper nigrum, and Zingiber officinale for the purpose of flavoring. As to the quantity of piper nigrum, since piper nigrum is commonly known as black pepper, and Meydani suggest black pepper for its flavor, it would have been obvious to determine the amount of black pepper based on flavor preference. In addition, since black pepper is a flowering vine, it is construed as a plant extract, which is disclosed by Holtey to be in the range of 0.010 (or 10mg) to 5g (seen as 0.010 to 5.000 wt%, Page 4, third to last paragraph and page 5, first paragraph). Therefore, it would have been obvious to further comprise black pepper from piper nigrum in a similar manner for its dietary supplement.
If it is argued that the composition taught by the combination do not teach a microbially stable composition, it is noted that "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. (see MPEP 2112.01). In this case, since the combination teaches the claimed citric acid, and vitamin C, both of which are known antioxidants, there is a reasonable expectation that the composition taught by the prior art is also “microbially stable”.
Regarding Claims 4 and 16, Meydani further teaches wherein the composition contains, per 100 g, 500 mg to 2 g of (seen as 0.5-1.5wt%, page 3, line 8) extract from broccoli. Meydani does not specifically recite “Brassica oleracea italica”, however, since Brassica oleracea italica is the scientific name for simply broccoli, it is construed that Meydani’s generic “broccoli” is referring to the same broccoli absent additional recitation of a particular broccoli. For similar reasons applied to Claim 1, it would have been obvious to one of ordinary skill in the art to further comprise 0.5-1.5wt% of broccoli based on flavor preference. Since the invention of Meydani is directed to beverage powder as a whole, it is construed that the broccoli component in powdered form constitutes “extract from broccoli” and a “concentrate of broccoli” (as per Claim 16).
Regarding Claim 10, Holtey further teaches wherein the at least two other vitamins are selected from vitamins A and E (see page 4, sixth paragraph) and the composition contains, per 100 g of the composition, 80 mg of a-tocopherol equivalents (seen as 0.080wt% Vitamin E, page 6, sixth to last paragraph). While Holtey notes that retinol (Vitamin A) may be added to the vitamin component (page 4, sixth paragraph), Holtey does not specifically recite comprising 1500 µg to 4000 µg of retinol equivalents per 100g of the composition. However, Holtey provides vitamin B2 in the range of 0.001 + 0.0008% by weight (page 6, 7th to last paragraph) which equates to 1mg + 0.8mg, or 1000 µg + 800 µg, which overlaps with the claimed range. Therefore, it would have been reasonable to substitute with Vitamin A at an amount similar to any of the recited amounts for the vitamin component, for the purpose of obtaining the desired dietary supplement.
Regarding Claim 11, Holtey further teaches wherein the at least one monosaccharide is fructose (paragraph 29, page 5).
Regarding Claims 12 and 13, while Holtey discloses food components that are known to contain selenium and fiber (Walnut is a source of selenium and dietary fiber, page 4, 6th paragraph of the translations), the combination do not specifically recite the amounts of selenium and dietary fiber per 100g of composition. However, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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). See MPEP 2144.05.II.A.
Regarding Claim 15, Holtey further teaches a method of using the composition according to Claim 1 for the preparation of a solution for oral administration (dissolved in a glass of water, page 11, second paragraph of Example 2).
Claim(s) 3, 5, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to Claims 1 and 16, further in view of Tanaka et al. (JP 2018070464 A- see machine translations).
Regarding Claim 3, the combination is silent to comprising, per 100 g, 2.3 mg to 5 g of extract from coffee (Coffea arabica). Tanaka discloses a beverage powder composition (“powdered beverages”, Page 5, third paragraph of translations) comprising arabica coffee (page 2, second to last paragraph of translations) for the purpose of improving brain function (see page 3, paragraph 7 of translations). The beverage composition of Tanaka comprises 5g of coffee in a composition having a total weight of 185g (See Example 2, page 6 of translations), thereby providing a composition having 2.7g coffee per 100g of the beverage composition, being within the claimed range of 2.3mg to 5g.
Therefore, since both Holtey and Tanaka are directed to beverage powder compositions having health improving effects, it would have been obvious to one of ordinary skill in the art to further comprise 2.7g per 100g of powdered beverage of coffee arabica extract for the purpose of improving brain functions.
Regarding Claims 5 and 17, Holtey further teaches comprising an extract from blueberry (page 4, third to last paragraph), and Fukuda was relied on to further comprise turmeric extract (as applied in Claim 1). The combination is silent to wherein the composition contains an extract from coffee (Coffea arabica), an extract from sour cherry (Prunus cerasus), an extract from cabbage (Brassica oleracea acephala), and an extract from broccoli (Brassica oleracea italica), and guarana extract (per claim 17). As applied in the rejection of Claim 3, Tanaka is further relied on to teach a beverage composition comprising coffee extract for the purpose of improving brain functions.
As to the limitations of comprising an extract from sour cherry, cabbage, broccoli and guarana, since Holtey already describes various suitable plant extract components including extracts from various herbs, plants, and vegetables, selecting plant extract components would have been an obvious matter of choice based on the desired dietary supplement imparted by the plant extract components. This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected, and useful function. In re White, 39 F.2d 974, 17 C.C.P.A., Patents, 956; In re Mason et al., 156 F.2d 189, 33 C.C.P.A., Patents, 1144.
Since both Holtey and the claimed invention are directed to a nutritional supplement (paragraph 2 of Applicant’s specification), and Holtey discloses several types of plant extract components, it would have been obvious to one of ordinary skill in the art select any combination of plant extract components for its nutrition. The claimed combination of plant extract is not patentably distinct over the prior art which already teaches various combinations of plant extracts absent evidence establishing a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected, and useful function.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to Claim 1, further in view of Daikeler et al. (US 2010/0291050 A1).
Regarding Claim 6, Holtey further teaches wherein the at least two other vitamins are selected from B vitamins (page 4, 6th paragraph of the translations). The combination is silent to comprising, per 100 g of the composition, and 50 mg to 200 mg of algae powder. Daikeler is relied on to teach a nutritional composition for reducing oxidative damage (see abstract), wherein the composition can be in the form of a beverage powder (paragraph 16), and wherein the composition comprises about 60mg of algae powder per 100g of composition (see Example 1, paragraph 40) for its beneficial changes in cholesterol, blood pressure, and immune supporting properties (paragraph 33). That is, the composition of Daikeler discloses a composition where the amount per serving comprises 0.900g of algae powder (350mg Chlorella, 350mg Spirulina, and 200mg Bluegreen algae) within a composition comprising a total of 1507.4 per serving thereby constituting about 0.060g algae powder per 100g composition, or 60mg.
Regarding Claim 7, Holtey further teaches wherein the at least one monosaccharide is dextrose (glucose, see paragraph 29, page 5 of translations).
Regarding Claim 8, Holey further teaches comprising niacin, pantothenic acid, pyridoxine, riboflavin, thiamine, cyanocobolamine (B12 Cobalamin), biotin, and folic acid (page 4, 6th paragraph of translations). Holey do not specifically recite the particular amounts of each vitamin. However, since Holtey is directed to a nutritional composition having desired supplemental effects, and discloses all of the vitamins required by the claim, the particular amounts of each vitamins would have been an obvious matter of desired nutritional effects. That is, it would have been obvious to one of ordinary skill in the art to vary the quantities of the vitamins based on the desired health effects imparted by each vitamins. This would also be dependent on the supplemental requirement of the target consumer of the nutritional composition. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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). See MPEP 2144.05.II.A.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to Claim 1, further in view of Reulein (US 2016/0082061 A1).
Regarding Claim 9, while Holtey comprises tea extract which are known to comprise caffeine, the combination is silent to wherein the composition contains 100 mg to 1000 mg of caffeine per 100 g of the composition. Reulein is relied on to teach a nutritional composition (see abstract) in the form of a beverage powder (see paragraph 1), wherein the caffeine content can be 100-300mg to provide quick energy to improve endurance (see paragraph 33). In Example 1, Reulein comprises 300mg of caffeine in a composition having a total dry weight of 28.83g (see paragraphs 45-62, note that water is not included in the total dry weight), thereby providing a quantity of 1040mg caffeine per 100g composition (0.3g caffeine over 28.83g is 1.04g per 100g, or 1040mg). Since Reulein recites an amount of 100-300mg (paragraph 33), the teachings of Reulein would encompass a range of 0.349g caffeine per 100g composition, or 349mg per 100g composition, thereby overlapping with the claimed range.
Since Holtey and Reulein are directed to nutritional beverage compositions comprising caffein, it would have been obvious to one of ordinary skill in the art to comprise between 349mg to 1040mg caffeine per 100g composition for the purpose of providing the effects of quick energy and endurance.
Claim(s) 14, 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to Claim 10, further in view of Daikeler et al. (US 2010/0291050 A1) and Evafenyvesi (Curcumin extract stabilized by gamma-CD).
Regarding Claim 14, the combination is silent to wherein the composition contains
(i) amylase, protease, lactase, cellulase and lipase, and
(ii) a curcumin-gamma-cyclodextrin complex.
Daikeler is relied on to teach a nutritional composition for reducing oxidative damage (see abstract), wherein the composition can be in the form of a beverage powder (paragraph 16), and wherein the composition comprises an enzyme blend of Amylase, protease, lactase, cellulase, and lipase (see Table in Example 1, paragraph 40). Enzymes increases the bioavailability of antioxidants contained in superfoods and thus increases the antioxidant efficacy in the body in the most usable form (see paragraph 24). Therefore, since both Holtey and Daikeler are directed to nutritional compositions, and Holtey comprises food with antioxidants (such as green tea extract, ascorbic acid), it would have been
obvious to one of ordinary skill in the art to further comprise the blend of enzymes taught by Daikeler for the purpose of increasing the antioxidant efficacy in the body.
As to the limitation of the curcumin-gamma-cyclodextrin complex, Evafenyvesi discloses that capsules containing curcumin and gamma-cyclodextrin as dietary supplements results in 40 folds increase in bioavailability due to enhanced solubility and stability (see page 2, first paragraph).
Therefore, since the combination is directed to a composition comprising turmeric which therefore comprises curcumin, it would have been obvious to one of ordinary skill in the art to substitute the curcumin component with a curcumin-gamma-cyclodextrin complex for the purpose of improving the bioavailability of the curcumin component.
Regarding Claims 18-20, the combination is silent to comprising a gram-positive non-sporulating bacteria and/or gram-positive sporulating bacteria. Daikeler is relied on to teach a nutritional composition for reducing oxidative damage (see abstract), wherein the composition can be in the form of a beverage powder (paragraph 16), and wherein the composition comprises Lactobacillus acidophilus as a probiotic (paragraph 14) which assists the body’s naturally occurring gut flora, aiding in digestion and absorption of nutrients (paragraph 27).
Since both Holtey and Daikeler are directed to nutritional beverage compositions, it would have been obvious to one of ordinary skill in the art to further comprise Lactobacillus acidophilus as a source of probiotics for the purpose of aiding in digestion and absorption of nutrients.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over the combination as applied to Claim 6 further in view of Milon et al. (WO 2005/013711 A1).
Regarding Claim 17, the combination is silent to comprising, per 100g of the composition, 3g to 12g of guarana extract. Milon is relied on to teach a nutritional composition in the form of a beverage powder (see abstract) that comprises guarana extract as a source of additional caffeine (page 6, ln. 15-19), in an amount up to 5% by weight (equivalent to 5g per 100g composition). The purpose of the guarana extract is to provide a suitable taste balance together with other ingredients in the serving.
Since Holtey is directed to a beverage composition with components known to comprise caffeine (tea extract, page 4, 6th paragraph of the translations), it would have been obvious to one of ordinary skill in the art to further comprise guarana extract in an amount up to 5g per 100g of the composition for the purpose of adding additional caffeine and to provide a suitable taste balance.
Response to Arguments
Applicant’s arguments in the response filed 13 Aug 2025 has been considered, but is found not persuasive over the prior art of record.
Applicant argues on the basis that microbial stability is not a predictable result that can be achieved from combining elements of the cited references. (page 6, first paragraph of the remarks). However, the argument is not persuasive because Fukuda is relied on to teach quantities of citric acid and ascorbic acid (i.e. Vitamin C), both of which are present in the composition of Holtey, in a particular amount that provides “oxidation-preventing effect”. Furthermore, it is evident that Citric acid reduces the growth of pathogenic bacteria according to Suriyaprom et al. (Antioxidants of Fruits Extracts as Antimicrobial Agents against Pathogenic Bacteria, see Section 2.1. Organic Acids, first paragraph). For these reasons, the argument is not sufficient to overcome the prior art because it is submitted that the prior art composition would exhibit at least some degree of microbial stability due to the inclusion of antioxidants.
Applicant also argue that there is no reason to select certain combinations of elements other than using Applicant’s disclosure as a reference (Page 6, third paragraph of the remarks). However, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Furthermore, the court held that “a multitude of effective combinations does not render any particular formulation less obvious. This is especially true because the claimed composition is used for the identical purpose taught by the prior art.” See In re Corkill, 771 F.2d 1496, 1500, 226 USPQ 1005, 1008 (Fed. Cir. 1985). Since Holtey discloses ginger as a suitable plant extract, there is a prima facie case of obviousness to select ginger.
Applicant argues that Fukuda does not contemplate a composition that would be sufficiently microbially stable to prevent the need for a preservative (Page 6, fifth paragraph of the remarks). However, the argument is not persuasive because the claims are directed to a powder composition that “contains” various elements, wherein the term “contains” is construed as synonymous with the term “comprising”. The term “comprising” is inclusive or open-ended and does not exclude additional, unrecited elements (see MPEP 2111.03.I). Therefore, the claimed composition is not exclusive to a composition that is microbial stable without additional preservatives, and the claims do not require microbial stability to be solely dependent on the elements recited. Even in the case that it does, both ascorbic acid and citric acid are known preservatives based on the function imparted by the acids as an antioxidant. Therefore, there is structure within Applicant’s disclosure that conveys a composition that is “sufficiently microbially stable” without preservatives. Rather, it appears that the disclosure refers to the exclusion of “artificial preservatives” (paragraph 12 of the specification) which is not reflected in the claimed invention.
Applicant argues that the prior art are not addressed to the same kinds of compounds because Holtey is directed to a dietary supplement for headaches, nausea, well-being, free breathing, eye irritation and performance, whereas Fukuda is addressed to cholesterol suppressing effects, and Meydani is addressed to reducing risk of obesity (Page 7, second paragraph of the remarks). The arguments are not persuasive because the elements brought into the Holtey reference would not render the Holtey reference unsatisfactory. That is, Fukuda is relied on to modify the taste and impart oxidation-preventing effects. Meydani is also relied on to modify the particular elements based on flavor preference. Since the prior art are all directed to beverage powders, it would have been reasonably for one of ordinary skill in the art to combine the references based on taste and shelf stability. Furthermore, there is no evidence to suggest that one of ordinary skill in the art would not have combined the references to achieve a multiple health benefits. For these reasons, the prior art has been maintained.
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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/T.H.N/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792