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 .
Claim Status
Claims 1-20 are pending.
Claims 14-19 are withdrawn.
Claims 1-13 and 20 are currently under consideration.
Claims 1-13 and 20 are rejected.
Acknowledgement of Receipt
Applicants’ election without traverse of Group I., claims 1-13 and 20 drawn to a nutraceutical composition in the reply filed on 02/13/2026 is acknowledged. This Office Action is in response to Applicants’ elections, amendments and remarks filed 02/13/2026.
Priority
This application is a 371 which is a National Stage Entry of PCT/EP2022/057466 filed 03/22/2022, which claims benefit to FRANCE Application No. FR 2102836 filed 03/22/2021. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 03/04/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, this IDS has been considered by the Examiner.
Applicant Claims
The instant claims are directed to a nutraceutical composition comprising inulin and a Chilean wineberry extract, said Chilean wineberry extract comprising anthrocyanidins (claim 1); wherein the composition comprises 1 to 10 g of inulin and from 30 to 150 mg of Chilean wineberry extract (claim 2); wherein the inulin/Chilean wineberry extract weight ratio ranges from 5 to 350 (claim 3); wherein the inulin/Chilean wineberry extract weight ratio ranges from 80 to 90 (claim 4); wherein the inulin is extracted from the chicory root (claim 5); wherein the composition further comprises cholecalciferol (claim 6); wherein the composition comprises from 0.1 to 30 mg of cholecalciferol (claim 7); wherein the composition further comprises carnitine, riboflavin and zinc (claim 8); wherein the composition comprises from 1 to 10 g of inulin, from 30 to 150 mg of Chilean wineberry extract, from 100 to 500 mg of L-carnitine tartrate, from 0.15 to 5 mg riboflavin, from 5 to 56 mg zinc bisglycinate, and from 0.1 to 30 mg cholecalciferol (claim 9); wherein the composition additionally comprises at least one excipient and/or at least one pharmaceutically acceptable carrier (claim 10); wherein the composition is in a solid form (claim 11); wherein the composition is in the form of a powder in sachet for a drinkable solution or suspension, a tablet, a gelcap or a capsule (claim 12); wherein the composition is adapted for oral administration (claim 13); wherein the inulin/Chilean wineberry extract weight ratio ranges from 35 to 180 (claim 20).
Claim Objections
Claims 1, 3-4, 12 and 20 are objected to because of the following informalities:
(Claim 1, line 2) - The term “anthrocyanidins” appears to be misspelled. For instance, in the instant disclosure Applicants use the term “anthocyanidins” (see Spec., pg. 2, line 14) and “anthocyanins” (see Spec., pg. 4, line 36).
(Claim 12, line 2) - The article “a” should precede the term “sachet”.
(Claims 3-4 and 20, line 2) - Applicants may consider replacing the fraction bar with a colon and include the corresponding quantities for clarity, e.g., 5: 1 to 350: 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. § 103 (a) are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicants are advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 1-2 and 6-13 are rejected under 35 U.S.C. § 103 as being unpatentable over Morariu (US 2019/0151227 A1, pub. 05/23/2019) and in further view of Hester et al. (Journal of Nutrition and Metabolism. Vol. 2018, Article ID 7497260, 11 pages) herein referenced Morariu and Hester.
Morariu provides formulations comprising maqui berry or a maqui berry extract containing anthocyanins; wherein the formulation is in a stabilized form (abstract, claim 1). Echoing Applicants’ instant disclosure (see Spec., pg. 4, line 35; pg. 5, line 9) Morariu teaches that the maqui berry (Aristotelia Chilensis) comes from a berry plant indigenous to Chile and Argentina and that the anthocyanin content in the maqui berry is high ([0020]). Morariu discloses that there is 203 mg of total anthocyanin (TA) per 100 ml of maqui juice ([0020]). Maqui berry or extract may be used as a liquid or juice, pulp, or in solid, dried form and that the berry contains anthocyanins to include delfinidin 3,5-diglucoside-cyanidine-3-glucoara binoside-5-glucoside ([0021]).
Morariu discloses that a formulation comprising: maqui berry, a maqui berry extract or salt thereof containing an effective amount of one or more antioxidants, and a stabilizer, wherein the formulation is formulated for use in a beverage (claim 26) to mean that the formulation containing the maqui berry or maqui berry extract is combined with ingredients that are safe for human consumption ([0166]). Formulation Example 3 is encapsulated in a polysaccharide micro-capsule ([0170-0176], Tables 1-7).
Morariu teaches that preferably, the formulation will contain 0.01% - 80% by weight of the maqui berry or maqui berry extract ([0163]). Desirably, it will contain 0.1% - 10.0% by weight, or more preferably 1% - 5% by weight maqui berry or maqui berry extract ([0163]). Carriers can be chosen which will solubilize or disperse the active ingredients at such concentrations as provided and one embodiment contains about 1% - 5% by weight anthocyanins and 1% - 3% by weight flavonoid glucuronide in a liposomal carrier ([0163]). Morariu suggests that dosages above 500 mg/kg body weight of naturally occurring antioxidants (i.e., carnosine) are safe ([0055]), but does not provide a specific amount of maqui berry extract (mg).
Notably, Morariu teaches and suggests by exemplary embodiments that the ratio of carriers and excipients to maqui berry extract present percent by weight is significantly high (e.g., 96%) ([0169] Examples 1-6). Additional agents may be additionally incorporated into the maqui berry composition to include an agent that alters lipolytic activity ([0015], claim 15). While Morariu teaches inulin as an exemplary lipolytic agent ([0079]), none of the embodiments provided show inulin and a specific amount of inulin (grams) is not taught.
Hester focuses on the efficacy of an anthocyanin and prebiotic blend in modulating intestinal microbiota and intestinal inflammation (abstract). The study results suggest that regular consumption of the anthocyanin-prebiotic blend positively modulated the intestinal ecosystem and provided insights into the mechanisms of action and its impact on health benefits (abstract). Hester provides results demonstrating that prebiotics, including short-chain fructooligo-saccharides (scFOSs) and inulin included in the anthocyanin-prebiotic blend are beneficial to intestinal health (pg. 2, col. 1, para. 2).
Hester discloses that participants in the study were instructed to take one sachet of powder every morning with breakfast by mixing into beverage or food of choice. The supplement delivered 215 mg anthocyanins and 2.7 g prebiotic fibers daily and consisted of anthocyanins (144 mg European blueberry extract (35 mg anthocyanins), 202 mg black currant extract (60 mg anthocyanins), and 618 mg black rice extract (120 mg anthocyanins) and a prebiotic blend (1.9 g inulin and 1.1g scFOS) (pg. 3, col. 1, section 2.3).
Hester teaches 1.9 g of inulin. MPEP 2144.05 states that a prima facie case of obviousness exists in the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art.
While Chilean wineberry extract is not mentioned, other anthocyanin containing extracts (e.g., blueberry extract) are taught in an amount (i.e., 144 mg) that falls within the range recited in the instant claims (i.e., 30 to 150 mg). Looking to Morariu, in addition to teaching maqui berry extract, blueberry is taught as containing anthocyanins (see Morariu [0020] Table 1). Here the prior art makes obvious to employ maqui berry extract as maqui berry extract and blueberry extract are obvious variants. Thus, it would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to substitute and incorporate one known anthocyanin-containing extract of Hester with the specific maqui berry extract of Morariu for a similar purpose of improving subject health outcomes. Simple substitution of one anthocyanin-containing extract for another is within the purview of the skilled artisan and would yield predictable results.
Regarding claims 6, Morariu discloses 1, 25-dihydroxy vitamin d3 ([0134]) which is known in the art as the active form of cholecalciferol (vitamin d3).
Regarding claim 8, Morariu discloses that the maqui berry formulation may be combined with a combination of a lipoic acid, a carnitine, and a carnosine and suggests such a combination carriers a particular usefulness ([0125]).
Acetyl-L-carnitine is taught in paragraphs [0073-0074] [0124], and in Table 4 in which the formulation is encapsulated in a polysaccharide micro-capsule ([0172-0173]).
Morariu teaches that synergistic intracellular glutathione inducers and precursors of glutathione such as riboflavin may be incorporated in the formulation ([0086]).
Morariu teaches that in particular, preferred embodiments, in addition to the antioxidants present in the maqui berry, additional antioxidants may be added to formulation; exemplary antioxidants include, but are not limited to zinc and its derivatives including zinc amino acid chelates ([0091]). In particular carnosine chelated to zinc ions enhances carnosine activity as a superoxide radical scavenger due to the presence of zinc ions ([0054-0055]).
Regarding claim 7 and claim 9, it would have been prima facie obvious to employ the cholecalciferol, carnitine, riboflavin, and zinc taught by Morariu and use routine experimentation and optimization to achieve the target amounts with expected results. MPEP 2144.05 states that where 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. Moreover, Morariu teaches throughout that an appropriate effective amount may be determined by one of ordinary skill in the art using only routine experimentation ([0162], [0153], [0157], [0177]).
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 which is to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art. In re Kerkhoven, 626 F.2d 846 (CCPA 1980). For instance, Morariu provides an embodiment wherein there is a high carrier (i.e., inulin) to maqui berry extract ratio and glutathione, carnosine, and carnitine are present at 3.0, 1.0, and 1.0 % by weight respectively ([0172-0173]). Morariu teaches riboflavin as a glutathione precursor ([0086]) and that zinc ions enhance carnosine activity ([0054-0055]). Lastly, cholecalciferol, carnitine, riboflavin, and zinc are widely recognized and commonly incorporated in such health benefiting blends for oral administration, absent a clear showing of evidence to the contrary.
Regarding claims 10-13, Morariu teaches that the stabilized (i.e., solid) form of the maqui berry is orally administered on its own or together with other antioxidants and synergistic compounds (i.e., excipients) disclosed that are suitable for oral administration such as a beverage ([0016], claim 26). Morariu discloses that carriers can be chosen to solubilize or disperse the active ingredients at concentrations provided ([0163]).
Claim 5 is rejected under 35 U.S.C. § 103 as being unpatentable over Morariu in view of Hester as applied to claims 1-2 and 6-13 above further in view of Viuda-Martos et al. (Royal Society of Chemistry, Food & Function, 2018, 9, 573) herein referenced Viuda-Martos.
The teachings of Morariu and Hester above are incorporated herein.
Regarding claim 5, Morariu and Hester do not mention chicory.
Viuda-Martos addresses the bioavailability of anthocyanins from the Chilean berries commonly named Chilean wineberry or “maqui berry” (Aristotelia chilensis (Molina) Stuntz) which has been accepted hitherto, as being very low due in part to anthocyanins being unstable compounds, being very sensitive to temperature, light and changes in pH conditions (pg. 573, col. 2, para. 1). Viuda-Martos conducts a study with maqui berry extract samples and dietary fibers that include long-chain inulin from chicory (IF) (pg. 574, see Materials and Methods). Samples obtained include maqui + inulin (M-IF) (pg. 579, Table 2 Polyphenolic profile, M-IF).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to apply the chicory taught by Viuda-Martos in the maqui berry composition taught by Morariu in view of Hester with expected results. One would be motivated to do so with a reasonable expectation of success because Viuda-Martos provides data from in the vitro digestion stability of polyphenolic compounds of maqui berry mixed with different dietary fibers (i.e., chicory) contributes to the stabilization of anthocyanins, phenolic acids, and flavonoid compounds present in maqui due and that the dietary fibers help provide sufficient levels for absorption during gastrointestinal digestion, especially in the early phases of gastrointestinal digestion (pg. 582, see Conclusion).
Claims 3-4 and 20 is/are rejected under 35 U.S.C. § 103 as being unpatentable over Morariu and Hester as applied to claims 1-2 and 6-13 above, further in view of Fredes et al. (LWT- Food Science and Technology 91, 2018, 549-556) herein referenced Fredes.
The teachings of Morariu and Hester above are incorporated herein.
Morariu and Hester do not teach the recited ratios.
Fredes discloses a study involving microencapsulation of maqui juice (MJ) by spray drying to protect anthocyanins in formulations (abstract). Fredes’ focus is on the influence of each maqui-anthocyanin and encapsulating agent (EA) (inulin (IN) or sodium alginate (ALG)) on the anthocyanin encapsulation efficiency (EE), the stability during storage and the bio-accessibility in in vitro digestion model (abstract). Fredes found that with IN, the highest EE of anthocyanins was obtained (abstract). Fredes teaches an EA system in which IN is combined with MJ. The disclosed preparation of the MJ microparticles entails using IN (2.8-10g) dissolved in distilled water and then MJ (2.33 g) is added, followed by a spray drying process (pg. 550, section 2.3). Fredes is focused on the anthocyanin profile (mg/g, % w/w) (pg. 552, sec. 3.1) and discovers that for the MJ-IN system, the higher the EA content, the greater the EE of anthocyanins (pg. 552, section 3.2). The (TA) content (2.8 ± 0.1 a mg cy-3-glu/g) in MJ-IN microparticles is found to be greater than previously reported in the art (pg. 552, sec. 3.3; see Table 1).
It would have been prima facie obvious to a person of ordinary skill in the art, ahead of the effective filing date of the claimed invention, to employ the high inulin to maqui berry juice ratio taught by Fredes in the composition of Morariu in view of Hester with expected results. One would be motivated to do so with a reasonable expectation of success because as mentioned above, as Morariu teaches anthocyanin/ maqui berry juice ratio ([0020]) and Hester discloses anthocyanins/ extract relationships, both looking to enhance delivery of actives. Fredes provides the means to do so. Fredes optimizes TA amounts and EE with the use of EA, and particularly with IN. Thus, one would be motivated to apply routine experimentation to optimize the IN to MJ ratios to achieve optimal encapsulation efficiency to suggest enhanced delivery of the active agents, improved subject compliance, and overall better health outcomes. MPEP 2144.05 states that where 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. Applicants, to establish unexpected results over a claimed range must provide and demonstrate a sufficient number of tests both inside and outside the claimed range to show criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). MPEP 716.02(d)(II.).
For the foregoing reasons the instant claims are rendered obvious by the teachings of the prior art.
Conclusion
Claims 1-13 and 20 are rejected; no claims are currently allowable.
The Examiner asks Applicant to provide support for the amendments in the application disclosure by referencing page numbers, paragraphs, figures, etc. for the sake of compact prosecution. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Karen Ketcham whose telephone number is (571) 270-5896. The examiner can normally be reached 900-500 ET.
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/Karen Ketcham/Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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