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 .
Priority
No foreign priority has been claimed.
Drawings
The drawings are not of sufficient quality to permit examination. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
Applicant is given a shortened statutory period of TWO (2) MONTHS to submit new drawings in compliance with 37 CFR 1.81. Extensions of time may be obtained under the provisions of 37 CFR 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of SIX MONTHS set by statute (35 U.S.C. 133). Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
The instant drawing contain notations that are pale and barely readable:
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Election/Restrictions
In response to the Election of Species Requirement mailed May 19, 2026, Applicant states the following:
Applicant elects the following:
Species A: amino acids (theanine, gamma-aminobutyric acid (GABA)); and
Species B: Inulin (chicory root fiber).
In the Election requirement mailed May 19, 2026, Examiner indicated the following patentably distinct species:
Species A: vitamins or amino acids (folic acid, thiamine) or amino acids (theanine, gamma-aminobutyric acid (GABA)).
Species B: Inulin (chicory root fiber), or soluble corn fiber, or soluble tapioca fiber, or polydextrose.
Therefore, vitamins or amino acids (folic acid, thiamine) species among Species A have not been elected.
Soluble corn fiber, or soluble tapioca fiber, or polydextrose among Species B have not been elected.
Below is the listing of claims directed to the non-elected species:
Claim 4. The fortified confection composition of claim 1, wherein the low reducing potential dietary fiber component comprises soluble corn or soluble tapioca fiber.
Claim 5. The fortified confection composition of claim 1, wherein the low reducing potential dietary fiber component comprises polydextrose.
Claim 9. The fortified confection composition of claim 1, wherein the bioactive amine-containing agent comprises a vitamin comprising at least one amine group.
Claims 4, 5 and 9 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/01/2026.
Applicant’s election without traverse of claims 1-3, 6-8, 10-17 in the reply filed on 06/01/2026 is acknowledged.
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.
Claims 7, 8, 10, 14, 15, 17 are 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.
Claim 7 recites the following limitations:
The fortified confection composition of claim 1, wherein the confection utilizes starch- based gelling agents.
It is not clear how starch-based gelling agents are being “utilized” by the claimed composition.
Claim 8 recites the limitation "the bioactive amine-containing component" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite “bioactive amine-containing component". Claim 1 recites “a bioactive amine-containing compound”.
Claim 10 recites the limitation "the bioactive amine-containing agent" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not recite “bioactive amine-containing agent". Claim 1 recites “a bioactive amine-containing compound”.
Claims 14 and 15 do not further limit claim 1. Claims 14 and 15 recite the limitations of “may be achieved” and “may be decreased. This language suggests two mutually exclusive outcomes—may or may not be achieved or reduced. Claims 14 and 15 recite the limitation of a possible outcome that may or may not happen and therefore do not further limit claim 1.
The term “decreased” in claim 14 is a relative term which renders the claim indefinite. The term “decreased” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 17 recites the broad recitation “at a concentration of less than 75% of the original value”, and the claim also recites “with a preferred embodiment of 50-100%” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
It is further noted that claim 17 recites the limitation of “the reducing carbohydrate is present at a concentration of less than 75% of the original value with a preferred embodiment of 50-100% replacement of reducing sugars 0-10% w/w”. The term “original value” is not clear and is not defined by the claims. The phrase “50-100% replacement of reducing sugars 0-10% w/w”” is also not clear.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-8, and 10-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Holton, Jr. et al (US 20220287977 A1).
In regard to claim 1, Holton, Jr. et al discloses compositions configured for oral use that may be in chewable, tablet, pastille, or meltable forms (Abstract). In regard to claims 1, 8 and 13, Holton, Jr. et al discloses that compositions includes at least one active ingredient selected from caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12, vitamin C, lemon balm extract, etc. (Abstract, [0006]).
In regard to claims 1 and 10-12, Holton, Jr. et al discloses:
[0006] In one aspect, the disclosure provides a composition in chewable form, configured for oral use, the composition comprising: at least one active ingredient selected from the group consisting of cannabinoids, cannabimimetics, terpenes, caffeine, taurine, GABA, theanine, tryptophan, vitamin B6, vitamin B12 (or other B vitamins), vitamin C, lemon balm extract, ginseng, citicoline, sunflower lecithin, and combinations thereof; one or more sugar alcohols in an amount by weight of at least 50%, based on the total weight of the composition; pectin; and an organic acid, a gelation agent, or both, wherein the composition is a homogenous mixture.
[0010] In one embodiment, the at least one active ingredient comprises theanine.
[0012] In one embodiment, the at least one active ingredient comprises GABA.
[0039] In one embodiment, the at least one active ingredient comprises a combination of theanine, gamma-amino butyric acid (GABA), and optionally lemon balm extract. In one embodiment, the theanine is present in an amount of from about 3 to about 5% by weight, based on the total weight of the composition; the GABA is present in an amount of from about 4 to about 6% by weight, based on the total weight of the composition; and the lemon balm extract when present is in an amount from about 3 to about 4% by weight, based on the total weight of the composition.
[0173] In some embodiments, the active ingredient comprises an amino acid. As used herein, the term “amino acid” refers to an organic compound that contains amine (—NH.sub.2) and carboxyl (—COOH) or sulfonic acid (SO.sub.3H) functional groups, along with a side chain (R group), which is specific to each amino acid. ... Non-limiting examples of non-proteinogenic amino acids include gamma-aminobutyric acid (GABA), taurine (2-aminoethanesulfonic acid), theanine (L-γ-glutamylethylamide), hydroxyproline, and beta-alanine. In some embodiments, the active ingredient comprises theanine. In some embodiments, the active ingredient comprises GABA. In some embodiments, the active ingredient comprises a combination of theanine and GABA. In some embodiments, the active ingredient is a combination of theanine, GABA, and lemon balm.
Hence, Holton, Jr. et al discloses a bioactive amine-containing compound such as gamma-aminobutyric acid (GABA),and L-theanine (L-γ-glutamylethylamide).
In regard to the recitation of “a dietary fiber component with low reducing potential” in claim 1 and inulin in claims 2-3, Holton, Jr. et al discloses inulin ([0148], [0208], [0272], [0285], [0292], [0295]).
In regard to the recitations of decreased levels or lack of reducing sugars in claims 1 and 14-17, Holton, Jr. et al discloses:
[0208] In order to improve the sensory properties of the composition according to the disclosure, one or more sweeteners may be added. The sweeteners can be any sweetener or combination of sweeteners, in natural or artificial form, or as a combination of natural and artificial sweeteners. Examples of natural sweeteners include fructose, sucrose, glucose, maltose, isomaltulose, mannose, galactose, lactose, allulose, soluble tapioca fiber, inulin, stevia, honey, and the like. Examples of artificial sweeteners include sucralose, maltodextrin, saccharin, aspartame, acesulfame K, neotame, and the like. In some embodiments, the sweetener comprises one or more sugar alcohols. Sugar alcohols are polyols derived from monosaccharides or disaccharides that have a partially or fully hydrogenated form. Sugar alcohols have, for example, about 4 to about 20 carbon atoms and include erythritol, arabitol, ribitol, isomalt, maltitol, dulcitol, iditol, mannitol, xylitol, lactitol, sorbitol, and combinations thereof (e.g., hydrogenated starch hydrolysates). In some embodiments, the sweetener is sucralose, acesulfame K, or a combination thereof.
Hence, Holton, Jr. et al discloses that the presence of reducing sugars (carbohydrates) is not required. Reducing sugars could be fully substituted with artificial sweeteners or other sweeteners that are not reducing carbohydrates.
In regard to the recitation of a confection in claim 1, Holton, Jr. et al discloses chewable, tablet, or pastille that includes sweeteners (Abstract), [0208]). This reads on sweet food or preparation, i.e. confection (Abstract), [0208]).
In regard to claim 6, Holton, Jr. et al discloses a filler comprising one or more of soluble tapioca fiber and inulin ([0148], [0272], [0285]).
In regard to claim 7, Holton, Jr. et al discloses the “compositions as described herein comprise one or more fillers” including starches ([0144], [0147]).
More specifically in regard to starches, Holton, Jr. et al discloses:
[0147] “Starch” as used herein may refer to pure starch from any source, modified starch, or starch derivatives. Starch is present, typically in granular form, in almost all green plants and in various types of plant tissues and organs (e.g., seeds, leaves, rhizomes, roots, tubers, shoots, fruits, grains, and stems). Starch can vary in composition, as well as in granular shape and size. Often, starch from different sources has different chemical and physical characteristics. A specific starch can be selected for inclusion in the composition based on the ability of the starch material to impart a specific organoleptic property to composition. Starches derived from various sources can be used. For example, major sources of starch include cereal grains (e.g., rice, wheat, and maize) and root vegetables (e.g., potatoes and cassava). Other examples of sources of starch include acorns, arrowroot, arracacha, bananas, barley, beans (e.g., favas, lentils, mung beans, peas, chickpeas), breadfruit, buckwheat, canna, chestnuts, colacasia, katakuri, kudzu, malanga, millet, oats, oca, Polynesian arrowroot, sago, sorghum, sweet potato, quinoa, rye, tapioca, taro, tobacco, water chestnuts, and yams. Certain starches are modified starches. A modified starch has undergone one or more structural modifications, often designed to alter its high heat properties. Some starches have been developed by genetic modifications, and are considered to be “genetically modified” starches. Other starches are obtained and subsequently modified by chemical, enzymatic, or physical means. For example, modified starches can be starches that have been subjected to chemical reactions, such as esterification, etherification, oxidation, depolymerization (thinning) by acid catalysis or oxidation in the presence of base, bleaching, transglycosylation and depolymerization (e.g., dextrinization in the presence of a catalyst), cross-linking, acetylation, hydroxypropylation, and/or partial hydrolysis. Enzymatic treatment includes subjecting native starches to enzyme isolates or concentrates, microbial enzymes, and/or enzymes native to plant materials, e.g., amylase present in corn kernels to modify corn starch. Other starches are modified by heat treatments, such as pregelatinization, dextrinization, and/or cold water swelling processes. Certain modified starches include monostarch phosphate, distarch glycerol, distarch phosphate esterified with sodium trimetaphosphate, phosphate distarch phosphate, acetylated distarch phosphate, starch acetate esterified with acetic anhydride, starch acetate esterified with vinyl acetate, acetylated distarch adipate, acetylated distarch glycerol, hydroxypropyl starch, hydroxypropyl distarch glycerol, and starch sodium octenyl succinate.
In regard to the recitations of “wherein the bioactive amine-containing compound in the fortified confection composition retains a significant amount of its initial bioactivity when compared to the control and stored at a temperature of 20°C to 35°C” in claim 1, Holton, Jr. et al discloses that the presence of reducing sugars (carbohydrates) is not required. Holton, Jr. et al discloses that reducing sugars could be fully substituted with artificial sweeteners or other sweeteners that are not reducing carbohydrates. Further in this regard, it is noted that although the reference does not specifically disclose every possible quantification or characteristic of its product, these characteristics would have been expected to be as claimed absent any clear and convincing evidence and/or arguments to the contrary. The reference discloses the same starting materials and methods as instantly (both broadly and more specifically) claimed, and thus one of ordinary skill in the art would recognize that the retaining of initial bioactivity among many other characteristics of the product obtained by referenced method, would have been an inherent result of the process disclosed therein. The Patent Office does not possess the facilities to make and test the referenced method and product obtain by such method, and as reasonable reading of the teachings of the reference has been applied to establish the case of obviousness, the burden thus shifts to applicant to demonstrate otherwise.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cave et al (US 20220175719 A1) discloses an edible food product ([0013], [0014], [0064]) comprising GABA ([0097], [0125]) and L-theanine ([0097], [0136]), inulin and modified starch ([0222]).
Wan et al (US 20210361661 A1) discloses a semi-solid gelled food composition comprising theanine ([0017], [0019], [0085], [0086], [0091], claim 21), inulin ([0027]) sugar and starch ([0013], [0027], [0036], [0057], [0081], [0083], [0098], claim 12) and sugar ([0030], [0032], [0033], [0035], [0036], [0094], [0100], claims 15-17 and 29).
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/VERA STULII/ Primary Examiner, Art Unit 1791
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