DETAILED ACTION
Status of the Claims
Claims 1-16 are pending in the instant application and are being examined on the merits in the instant application.
Advisory Notice
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant Application is a Continuation of Application No. 18/366,945 which is a Continuation of Application No. 16/763,038 which claims benefit of the U.S. Provisional Application No. 62/696,955 (hereafter ‘955).
The U.S. effective filing date has been determined to be 11/04/2019, the filing date of the U.S. Application16/763,038. The examiner finds no support for “a plant-derived saccharide base” in ‘955, which limitation is supported in the claims filed 11/04/2019 in 16/673,038.
Information Disclosure Statement
The information disclosure statement submitted on 12/05/2024 was filed before the mailing date of the first office action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The instant Specification does not provide proper antecedent basis for the claimed “a plant-derived saccharide base” (claim 1, line 2).
Claim Objections
Claim 16 is objected to because of the following informalities: Claim 16 recites “iu” in lines 3 and 8 (“or beta-carotene, 250-25,000 iu” and “tocopherols and/or tocotrienoles, 5-1,000 iu”), which should be written as “IU”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 7-11, 13 and 16 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 pre-AIA the applicant regards as the invention.
Claim 11 is rejected as being indefinite because the claim recites “the amount of phytochemical is between 0.01 and 2400 milligrams per serving.” Claim 11 depends from claim 5 reciting “further comprising a cannabinoid, terpene, or phenolic phytochemical.” Claim 5 depends from claim 3 reciting “further comprising a nutritional, multivitamin, or multi-nutrient composition selected from the group consisting of one of more of: vitamins A, Bl, B2, B3, BS, B6, B9, Bl2, C, D2, D3, E, Kl, K2, K3, essential fatty acids, amino acids, bioflavonoids, alpha lipoic acid, coenzyme Q10, boron, calcium, chromium, copper, iron, lithium, manganese, magnesium, molybdenum, nickel, selenium, sodium, strontium, and zinc.” Which depends from claim 3 reciting “wherein the saccharide-base further includes lecithin and palm oil.” It is unclear what exactly “phytochemical” as recited in claim 11 - “the amount of phytochemical is between 0.01 and 2400 milligrams per serving.” – is referencing, and what a serving is required to be. Claim 11 recites the limitation "phytochemical" in 1. There is insufficient antecedent basis for this limitations in the claim. Appropriate clarification is required.
Claim 13 is rejected as being indefinite because the claim recites: "the saccharide base comprises tapioca syrup, isomalto-oligosaccharide (IMO) syrup, [ ... ], sorghum syrup, tagatose syrup, and the following sugar alcohols: erythritol syrup, mannitol syrup, sorbitol syrup, or xylitol syrup, ethylene glycol, glycerol, erythritol, threitol, arabitol, xylitol, ribitol, mannitol, sorbitol, galactitol, fucitol, iditol, and inositol combined with any combination of the following: palm oil, coconut oil, citric acid, malic acid, fumaric acid, tartaric acid, soy and/or sunflower lecithin, stevia (leaf) extract, monk fruit extract, saccharin, acesulfame, aspartame, neotame, or sucralose." [ emphasis added] where it is not clear (1) the claim uses the transitional phrase "comprising")(MPEP §2111.03) in a group of alternatives (MPEP §2117 & 2173.05(h)); and (2) the first grouping of "saccharides" lacks a proper conjunction between the last two elements "sorghum syrup, tagatose syrup" but rather Applicants claim creates a run-on group of "sugar alcohols" and another of "inositol combined with any combination of the following:" Therefore, it is unclear what exactly what claim elements are required by claim 13 for the oral mucoadhesive delivery system of claim 1 and 12. Appropriate clarification is required.
Claim 13 is further rejected as reciting 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 13 recites the broad recitation organic stevia extract, and the claim also recites organic stevia leaf extract” 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. Appropriate clarification is require.
Claims 7-11 and 16 each recite “per serving” (claims 7-11 in line 2 and claim 16 in line 1) in conjunction with an amount, however, the claim do not recite any serving size such that the limitation “per serving” lacks proper antecedent basis in the claims. Appropriate clarification is require.
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.
Claims 1 & 15 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by DAVIS (US 2010/0226904 A1; published September, 2010).
Applicant Claims
Applicant claims an oral mucoadhesive delivery system comprising: a plant-derived saccharide base; and a sweetener.
Disclosure of the Prior Art
DAVIS discloses a vitamin gummy formula ([0097], Table B) including organic sugar, brown rice syrup (instant claims 1, a plant-derived saccharide base, instant claim 13, “rice syrup” & “cane sugar syrup”), citric acid (instant claim 15) Multi-vitamin blend (300 mg) including “the multi-vitamin blend may include approximately 2500 IU of Vitamin A, 2 mg of Vitamin B-6, 6 mg of Vitamin B-12, 60 mg of Vitamin C, 400 IU of Vitamin D, 16 mg of Magnesium, 15 mcg of Choline, 15 mg of Zinc, 18.4 mg of Calcium, 150 mcg of iodine, and 15 mcg of inositol. About 0.1 % sodium citrate by weight may also be added to the candy slurry to maintain the pH of the slurry at about 3.0 to 3.5.” ([0099]).
DAVIS further discloses the starch-based gummy formula ([0112], Table D) including citric acid, organic sugar, tapioca syrup, starch, Multi-vitamin blend (300 mg), as discussed above (instant claims 1, 13 & 15).
Claims 1-5, 12, 14 & 15 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by NIETLING (US 2015/0086686 A1; published March, 2015).
Applicant Claims
Applicant claims an oral mucoadhesive delivery system comprising: a plant-derived saccharide base; and a sweetener. And further includes lecithin and palm oil (instant claims 2-3). Applicant claims the saccharide base comprises tapioca syrup, palm oil, citric acid, and lecithin (instant claim 12).
Disclosure of the Prior Art
NIETLING discloses an example composition comprising a plant-derived saccharide base (Tapioca Syrup-42DE), a sweetener (fructose, sucrose), palm oil (blending agent), sunflower lecithin, citric acid, ascorbic acid (Vitamin C), malic acid ([0055], Table II)(instant claims 1-4). The composition of Table II further includes “Dark Sweet Cherry Juice Concentrate” which would have inherently included polyphenol phytochemicals including cyanidin (instant claims 5 & 14)(see, e.g. WILKES – US 2009/0297681 A1: [0018], lines 1-5; and Jakobek et al. (“Anthocyanin content and antioxidant activity of various red fruit juices,” 2007, Deutsche Lebensmittelrundschau Vol. 103, No. 2, pp. 58-64: see whole document, particularly Tables 1-2, and Figure 1)).
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 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 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.
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. Applicant is 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 1-7 and 9-15 are rejected under 35 U.S.C. 103 as being unpatentable over DAVIS (US 2010/0226904 A1; published September, 2010) in view of NIETLING (US 2015/0086686 A1; published March, 2015) and WAN (WO 2018/027081 A1; published February, 2018).
Applicants Claims
Applicant claims are discussed above.
Determination of the scope
and content of the prior art (MPEP 2141.01)
DAVIS teaches that: “Recently, chewable supplements have been manufactured and sold in the form a gummy candy supplement. Now a selection of vitamin, mineral, and health supplements are being manufactured and sold in a chewable gummy form, including both children and adult supplements. The introduction of gummy supplements into the marketplace has been particularly helpful in getting children to take daily vitamin supplements. For adults that do not like swallowing pills, gummy supplements have also provided a non-pill alternative for adults to get their daily vitamin requirements.” ([0005]).
DAVIS further teaches that: “Although gummy candy was first introduced in 1920 as II gummy bears, 11 it was not until very recently that gummy candy was utilized as a delivery system for supplements. Traditional gummy candy is made from a gelatin base, which is similar to the base found in soft caramels, marshmallows, foam-filled wafers, licorice, wine gums, pastilles, chocolate coated mallows and a host of other sweets. Gelatin is a protein derived from animal tissue that forms thick solutions or gels when placed in water. Gelatin gives candy its elasticity, the desired chewy consistency, and a longer shelf life.” ([0006]). And that: “Since gelatin is a tasteless and odorless compound, sweeteners and flavorings are typically added to the gelatin base to give the gummy candy its taste. Thus, gummy candies are generally made from a blend of com syrup, sugar, gelatin, color, and flavor.” ([0007]).
DAVIS teaches that: “a need exists in the art for an organic gummy-based supplement. In particular, there is a need for organic gummy delivery system that enables supplements and pharmaceuticals to be easily and quickly digested by users of all ages.” ([0010]).
DAVIS teaches that: “According to one implementation, the chewable composition includes a drug delivery system for delivering dietary supplements and/or pharmaceutical compounds to a user’s body. The drug delivery system includes a drug delivery vehicle in the form of a gummy candy, and a dietary supplement and/or a pharmaceutical compound as active ingredients of the gummy candy. In particular, the delivery vehicle may include an organic gummy candy. The gummy candy may include organic sweeteners, a binding agent, and natural flavors, colors, and preservatives. For example, in one implementation, the gummy candy may include organic sugar, organic syrup, pectin, citric acid, lactic acid, natural colors, natural flavors, fractionated coconut oil, and carnauba wax.” ([0012]). And that: “The active ingredients may include an over-the counter (OTC) drug or a prescription drug to provide a desired effect on the user. In addition to OTC or prescription drugs, the active ingredients may also include nutraceuticals (i.e., extracts of food purported to have a medicinal effect on human health) such as botanical and herbal extracts and antioxidants, or any combination of food supplements such as vitamins, minerals, soluble and insoluble fiber, herbs, plants, amino acids, and digestive enzymes." ([0013]).
DAVIS discloses a vitamin gummy formula ([0097], Table B) including organic sugar, brown rice syrup (instant claims 1, a plant-derived saccharide base, instant claim 13, “rice syrup” & “cane sugar syrup”), citric acid (instant claim 15) Multi-vitamin blend (300 mg) including “the multi-vitamin blend may include approximately 2500 IU of Vitamin A, 2 mg of Vitamin B-6, 6 mg of Vitamin B-12, 60 mg of Vitamin C, 400 IU of Vitamin D, 16 mg of Magnesium, 15 mcg of Choline, 15 mg of Zinc, 18.4 mg of Calcium, 150 mcg of iodine, and 15 mcg of inositol. About 0.1 % sodium citrate by weight may also be added to the candy slurry to maintain the pH of the slurry at about 3.0 to 3.5.” ([0099])(instant claims 4, 7, 11 & 13).
DAVIS further discloses the starch-based gummy formula ([0112], Table D) including citric acid, organic sugar, tapioca syrup, starch, Multi-vitamin blend (300 mg), as discussed above (instant claims 1, 13 & 15), or the inclusion of selenium in an amount of about 5 to about 400 micrograms (instant claim 9).
DAVIS further teaches the inclusion of tapioca syrup - In one implementation, the additives may include sodium citrate, organic sweeteners such as organic sugar and/or organic syrup (e.g., rice and tapioca), in liquid and/or powdered form.” ([0030]), “The syrup may include rice syrup, tapioca syrup, or any other suitable organic sweetener or combination thereof.” ([0059]), and in the starch-based gummy formula ([0112], Table D)(instant claims 12-13).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of DAVIS is that DAVIS does not expressly teach the inclusion of lecithin and palm oil (instant claims 2-3, 12, 13), the inclusion of a cannabinoid, terpene, or phenolic phytochemical in an amount between 0.01 and 2400 mg per serving (instant claims 5 & 11).
NIETLING teaches that: “The present disclosure relates generally to an insoluble fiber composition. In one embodiment the composition is a soft and chewy confectionary with a high dietary fiber content that includes a greater amount of insoluble fiber than soluble fiber.” ([0002]). And that: “Chemically, dietary fiber consists of non-starch polysaccharides such as arabinoxylans, cellulose, and many other plant components such as resistant starch, resistant dextrins, inulin, lignin, waxes, chitins, pectins, beta-glucans, and oligosaccharides.” ([0019]).
NIETLING teaches that: “Non-limiting examples of suitable blending agent
components include […] lecithin […].” ([0029])(instant claims 2-3, 12-13).
NIETLING teaches that: “While the present composition is primarily intended to be a fiber composition, it is contemplated that embodiments of the invention can include supplements such as, but not limited to, vitamins, minerals, herbs, botanicals, plant derived supplements, animal derived supplements, therapeutic compounds, and mixtures thereof.” ([0035]).
NIETLING teaches that: “Non-limiting examples of such other components include: calcium, potassium, B vitamins, vitamins A, C, D, E, and K, folic acid, other vitamins and minerals commonly known in the art and used for supplementing the diet; extracts and active phytochemicals including ferulic acid (from apples), ginseng, ginko biloba, beta carotene, capsicanoids, anthocyanidins, bioflavinoids, d-limonene, isothiocyanates, cysteines from garlic, ginger, grapes, catechins and polyphenols from teas, onions, phytosterols, isoflavones, lycopene, curcumin, caffeine; glucosamine, chondroitin,; melatonin, seratonin; and mixtures thereof.” ([0036]).
NIETLING teaches that: “The compositions of the present invention can be formed into any suitable, ingestible form. Non-limiting examples of the form of the compositions include: soft chew” ([0038]). And that: “Soft chew is intended to mean a product which is solid at room temperature and which are soft to chew and which is functionally chewy because the product has some plastic texture during the process of mastication in the mouth.” ([0039])(instant claim 6).
NIETLING discloses an example composition comprising a plant-derived saccharide base (Tapioca Syrup-42DE), a sweetener (fructose, sucrose), palm oil (blending agent), sunflower lecithin, citric acid, ascorbic acid (Vitamin C), malic acid ([0055], Table II)(instant claims 1-4). The composition of Table II further includes “Dark Sweet Cherry Juice Concentrate” which would have inherently included polyphenol phytochemicals including cyanidin (instant claims 5 & 14)(see, e.g. WILKES – US 2009/0297681 A1: [0018], lines 1-5; and Jakobek et al. (“Anthocyanin content and antioxidant activity of various red fruit juices,” 2007, Deutsche Lebensmittelrundschau Vol. 103, No. 2, pp. 58-64: see whole document, particularly Tables 1-2, and Figure 1)).
WAN teaches health management compositions (title, abstract, see whole document), and particularly teaches that: “The application relates generally to nutraceutical composition in gelled or gummy formula, methods of administration of various gummy or gelled compositions for nutraceuticals, and kits comprising various gummy compositions for nutraceuticals.” (p. 1, §Technical Field).
WAN further teaches that: "In one embodiment, the application provides a nutraceutical composition comprising a neuroprotecting composition, an anti-inflammatory composition, a cardiovascular protecting composition, an antioxidant composition, and a gelling component in a sufficient amount to provide a cohesive gelled product.” (p. 5, last paragraph). And that: "The anti-inflammatory composition includes agent that is capable of reduce or attenuate inflammation. In one embodiment, the anti-inflammatory composition comprises acetylsalicylic acid [ ... ]." (p. 7, §Anti-inflammatory composition, paragraphs 1-2). WAN further teaches the inclusion of Fibers and prebiotics including inulin (p. 14, §Fibers and prebiotics, paragraphs 1-2).
WAN teaches the inclusion of plasticizer including sugar alcohols such as sorbitol, xylitol, mannitol, glactitol, maltitol, erythritol, among others (p. 22, §Plasticizer)(instant claim 13). WAN teaches the inclusion of Fats and oils such as palm (kernel) oil, among others, and particularly that: "This edible oil component makes up part of the group of ingredients that adjust the taste, texture, and improve the melt and mouth feel of the flavored chewy or gummy confection." (pp. 22-23, §Fats and oils)(instant claims 3, 12-13). WAN teaches the inclusion of emulsifiers such as lecithin, and particularly that: "The emulsifier may assist in holding together the fats and water and other components together in a homogeneous composition. In one embodiment, the emulsifier may assist in the formation of a "water and oil" emulsion that creates the smooth texture of the finished product." (p. 24, §Emulsifiers)(instant claims 2-3, 12-13).
WAN further teaches that the inclusion of minerals in the form of salts or chelates (p. 13, §Minerals composition, 1st paragraph), and particularly “In some embodiments, per daily dosage, the composition includes at least 25mg, 30mg, 50mg, 60mg, or 70mg of Zinc.” (instant claim 7); “In some embodiments, per daily dosage, the composition includes at least 150mcg, 200 mcg, or 250mcg of selenium.” (instant claim 9); and “In some embodiments, per daily dosage, the composition includes at least 400mg, 500mg, or 800 mg of magnesium.” (instant claim 10)( p. 13, §Minerals composition).
WAN teaches the inclusion of Neuroprotecting composition (p. 6, line 7 through p. 7, 3rd paragraph), and teaches including d-limonene (a cyclic monoterpene) (p. 9, line 3) (instant claim 14).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a gummy or soft chew vitamin/mineral/photochemical supplement composition, as suggested by DAVIS, NIETLING, and WAN, and produce the instantly claimed invention because soft chews are favored by children and adults that do not like swallowing pills, as suggested by DAVIS.
One skilled in the art would have been motivated to do so because it is generally considered to be prima facie obvious to combine compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a composition that is to be used for an identical purpose. The motivation for combining them flows from their having been used individually in the prior art, and from the being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the combination of conventional components of soft-chew/gummy vitamin/mineral/phytochemical supplement compositions. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Kerkhoven, 626 F.2d 848, 205 USPQ 1069 (CCPA 1980).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over DAVIS in view of NIETLING and WAN as applied to claims 1-7 and 9-15, above, and further in view of SETERNES (US 2011/0268771 A1; published November, 2011)
Applicants Claims
Applicant claims are discussed above.
Determination of the scope
and content of the prior art (MPEP 2141.01)
DAVIS, NIETLING and WAN each teach/disclose vitamin/mineral/phytochemical supplement compositions, as discussed above and incorporated herein by reference.
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of DAVIS/ NIETLING/WAN is that DAVIS/ NIETLING/WAN does not expressly teach including lithium in their vitamin/mineral/phytochemical supplement compositions.
SETERNES teaches an oral pharmaceutical composition in unit dose form, each unit dose including a lipophilic drug substance within a soft, chewable gelled oil-in-water emulsion (abstract, see whole document). SETERNES teaches including hydrophilic drug substance such as lithium sulfate ([0021]), and particularly in a per dose unit amount (mg) of 42-38 mg (p. 7, col. 1, Table 2- continued).
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a gummy or soft chew vitamin/mineral/phytochemical supplement composition, as suggested by DAVIS, NIETLING, and WAN, and produce the instantly claimed invention because soft chews are favored by children and adults that do not like swallowing pills, as suggested by DAVIS, and further to include lithium sulfate, as suggested by SETERNES, as a hydrophilic drug substance for the benefits of the same.
One skilled in the art would have been motivated to do so because it is generally considered to be prima facie obvious to combine compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a composition that is to be used for an identical purpose. The motivation for combining them flows from their having been used individually in the prior art, and from the being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the combination of conventional components of soft-chew/gummy vitamin/mineral/phytochemical supplement compositions. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Kerkhoven, 626 F.2d 848, 205 USPQ 1069 (CCPA 1980).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over DAVIS in view of NIETLING and WAN as applied to claims 1-7 and 9-15, above, and further in view of LOWE (US 2016/0000843 A1; published January, 2016), HENDERSON (US 7,153,503; published December, 2006); HSIA (US 5,976,548; published November, 1999) and WESTERLUND (US 2014/0161784 A1; published June, 2014).
Applicants Claims
Applicant claims an oral mucoadhesive delivery system comprising: a plant-derived saccharide base; and a sweetener (instant claim 1 ). Applicant further claims the composition of claim 1 further comprising per serving: (a) magnesium as glycinate, malate, or taurinate 10-400 mg; (b) kelp, 5-100 mg; (c) vitamin A as retinyl palmitate or acetate or beta-carotene, 250-25,000 iu; (d) vitamin B1, 0.5-100 mg; (e) vitamin B2, 0.5-100 mg; (f) vitamin B6, 0.5-100 mg; (g) Vitamin B3, 0.5-500 mg; (h) vitamin B5, 5-500 mg; (i) Vitamin B12, 5-10,000 mcg as cyanocobalamin or methylcobalamin or hydroxocobalamin or adenosylcobalamin;
(j) folic acid or methyl-folate or folinic acid, 10-10,000 mcg; (k) non-GMO vitamin
C, 10-2,000 mg; (l) vitamin D3, 100-40,000 IU; (m) vitamin E as d-alpha tocopherol
or dl-alpha tocopheryl and/or mixed tocopherols and/ortocotrienols, 5-1,000 iu for
alpha- tocopherol and 5-500 mg for mixed tocopherols including gamma-tocopherol
or the family of tocotrienols, 5-1,000 iu; (n) boron as glycinate 0.5-10 mg; (o) copper as bisglycinate, 0.1-5 mg; (p) zinc as bisglycinate, 2.5-50 mg; (q) manganese as bisglycinate, 0.5-10 mg; (r) selenium as glycinate, 5-400 mcg; (s) molybdenum as glycinate, 10-1,000 mcg; and (t) chromium as nicotinate glycinate, 10- 1,000 mcg; and a (u) terpene, (v) phenolic, and (w) cannabinoid (instant claim 15).
Determination of the scope
and content of the prior art (MPEP 2141.01)
DAVIS, NIETLING and WAN each teach/disclose vitamin/mineral/phytochemical supplement compositions, as discussed above and incorporated herein by reference.
WAN further teaches that: In some embodiments, per daily dosing, the nutraceutical composition comprises at least 300mcg, 400mcg, 450mcg, or 500mcg of folate, at least 3mg, 4.5mg, 5.5mg, 6.5mg of B1 (claim 15, item b), at least 3mg, 5mg, 6mg, or 7mg of B2 (Id., item e), at least 12mg, 15mg, 16mg, 18mg, or 20mg of niacinamide (syn. Vitamin B3, Id., item g), at least 4mg, 6mg, 7mg, 8mg, 10mg of B6 (Id., item f), at least 15mcg, 20mcg, 30mcg, 50mcg, 1mg, 2mg, 4mg, 5mg, or 6mg of B12 (Id., item i), at least 30mcg, 40mcg, 50mcg, 80mcg, or 1mg of biotin, or at least 7mg, 10mg, 12mg, 15mg, or 20mg of pantothenic acid (syn. Vitamin B5, Id., item h)(paragraph bridging pp. 11-12).
WAN further teaches including: folate not less than 400mcg (i.e. folic acid; claim 15, item j), pantothenic acid not less than 5mg, biotin not less than 30mcg. In one embodiment, the vitamin composition comprises Vitamin E not less 60 IU (Id., item m), Vitamin C not less than 90mg (Id., item k), or beta-carotene not less than 2000 IU (claim 15, item c). WAN teaches including Vitamin D group of fat-soluble secosteroids including Vitamin D3 (cholecalciferol) in a "per daily dosage, the composition includes at least 400IU, 600IU, 800IU, 1000IU, 1200IU, 1500IU, or 2000IU of Vitamin D." (claim 15, item l)(p. 12, 2nd paragraph). WAN further teaches including; "In some embodiments, per daily dosage, the nutraceutical composition includes at least 500IU, 800IU, 1000IU, 1500IU, 2000IU, 2500IU or 3000IU of Vitamin A." ( claim 15, item c )(p. 12 3rd paragraph).
WAN teaches inclusion of magnesium, zinc and selenium ( claim 15, items a, p & r) as discussed above, and further includes copper (Id., item o ), manganese (Id., item q), molybdenum (Id., items), and chromium (Id., item t) and further that they may be in the form of chelates (p. 13, §Minerals, 1st paragraph).
WAN teaches inclusion of terpenes (p. 6, §Neuroprotecting composition, 3rd paragraph) andphenolics (p. 2, 5th paragraph; p. 7, 3rd paragraph; p. 8, §Antioxidant composition, 1st paragraph)(claim 15, items u & v). WAN teaches including d-limonene (a cyclic monoterpene)(p. 9, line 3)(claim 15, item u).
Ascertainment of the difference between
the prior art and the claims (MPEP 2141.02)
The difference between the rejected claims and the teachings of DAVIS/ NIETLING/WAN is that DAVIS/ NIETLING/WAN does not expressly teach each of the specific vitamin/mineral/phytochemical supplement constituents of instant claim 16, and particularly kelp (claim 15, item a), boron (Id., item m), a cannabinoid (Id., item v), or the chelates are (bis)glycinates (Id., items n-s).
HSIA teaches nutritional supplements to the human diet (see whole document) including kelp in an amount of 10 mg (Examples 1-3 - col. 13, line 57; col. 14, line 51; col. 15, line 43)(instant claim 15, item b).
WESTERLUND teaches dietary supplements including about 1 mg of boron (abstract, see whole document)(claim 15, item n).
HENDERSON teaches a comprehensive dietary supplement of bioavailable minerals, vitamins, among others, including minerals as amino acid chelates (see whole document, particularly the abstract). HENDERSON further teaches that: “studies have found that minerals that are chelated or complexed by amino acids, or combinations of amino acids and vitamin acid ligands, (e.g. glycinates, arginates, and nicotinate glycinates) are bioavailable forms that render the minerals more readily absorbed by virtue of the fact that transport across the intestinal mucosa and into the portal circulation is accomplished by an amino acid transport mechanism and not by traditional mineral acid transport mechanisms. Once in the blood, the amino acid chelates do not bind directly to serum proteins, but are transported directly to target tissues in the chelated form. Thereafter, the mineral is released intracellularly from the chelate. Importantly, this direct transport results in greatly improved bioavailability of the minerals to the end organs and/or cells and works independent of either mineral saturated or reduced concentrations of serum proteins. Additionally, unlike most conventional mineral salts that are commercially available, amino acid chelates do not cause changes in bowel habits after oral administration. This is in contrast to notable examples of conventional iron salts such as iron sulfate, which may cause constipation, and magnesium citrate which commonly causes loose stools or diarrhea.” [emphasis added]( col. 5, lines 23-44)(instant claims 15, items n-t, glycinates, nicotine glycinates).
LOWE teaches high cannabidiol cannabis strain and preparations and products derived from the same (see whole document). LOWE teaches that cannabidiol (CBD) has been implicated in the treatment of a wide variety of diseases and symptoms, including cancer, nausea, chronic pain, spasms, seizures/epilepsy, anxiety, psoriasis, Crohn' s disease, rheumatoid arthritis, diabetes, schizophrenia, post-traumatic stress disorder (PTSD), alcoholism, strokes, Multiple Sclerosis, and cardiovascular disease ([0015], claim 16)(instant claims 5 & 16, cannabinoid). LOWE teaches the inclusion of at least one terpene ([0096]). LOWE teaches that: “Unlike THC, CBD does not produce psychoactive effects in humans. CBD is reported to exert analgesic, antioxidant, anti-inflammatory, and immunomodulatory effects.” ([0009]).
LOWE teaches that the cannabis cultivar provided herein can be processed into a variety of products or preparations ([0074]) including edible products such as gummy candy ([0079] & [0099])( cannabis cultivar implies a phytocannbinoid, see LOWE: [0006]; instant claim 15, item w). Thus, it would have been prima facie obvious to include a cannabinoid, such as CBD, in the composition of DAVIS/WAN as the active ingredient therein as a pharmaceutical component for analgesic, antioxidant, anti-inflammatory, and immunomodulatory effects, as suggested by LOWE.
Finding of prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a gummy or soft chew vitamin/mineral/phytochemical supplement composition, as suggested by DAVIS, NIETLING, and WAN, and produce the instantly claimed invention because soft chews are favored by children and adults that do not like swallowing pills, as suggested by DAVIS, and further to include specific constituents ( e.g. Vitamins/Minerals/dietary supplements) in known daily (recommended) amounts, as suggested by HSIA and WESTERLUND, and further to include minerals in the form of glycinates, nicotinate glycinates which are bioavailable forms that render the minerals more readily absorbed, as taught by HENDERSON, and further to include a pharmaceutical agent such as CBD reported to exert analgesic, antioxidant, anti-inflammatory, and immunomodulatory effects, as suggested by LOWE.
One skilled in the art would have been motivated to do so because it is generally considered to be prima facie obvious to combine compositions, each of which is taught by the prior art to be useful for the same purpose, in order to form a composition that is to be used for an identical purpose. The motivation for combining them flows from their having been used individually in the prior art, and from the being recognized in the prior art as useful for the same purpose. As shown by the recited teachings, instant claims are no more than the combination of conventional components of soft-chew/gummy vitamin/mineral/phytochemical supplement compositions. It therefore follows that the instant claims define prima facie obvious subject matter. Cf. In re Kerkhoven, 626 F.2d 848, 205 USPQ 1069 (CCPA 1980).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application Nos. 18/970,207 (claims 1-8; hereafter ‘207); 18/976, 609 (claims 1-18; hereafter ‘609); and 17/689,844 (claims 1, 5-23 & 25-28; hereafter ‘844) in view of DAVIS; NIETLING; WAN; LOWE; HENDERSON; HSIA and WESTERLUND (as cited herein above).
Instant claims are discussed above.
Copending ‘207 claims an oral mucoadhesive delivery system for a pharmaceutical agent, comprising: a saccharide base, soy or sunflower lecithin, palm oil, one or both of a natural or artificial sweetener in an amount of 1 mg to 5 grams (5000 mg) per serving, a salt in an amount of 5-200 mg per serving; and a pharmaceutical agent in an amount of 0.001-3,000 mg per serving (claim 1), the oral mucoadhesive delivery system comprises: tapioca syrup, palm oil, citric acid, and soy or sunflower lecithin, and salt (claim 2).
Copending ‘609 claims a composition comprising hemp oil having a cannabidiol (CBD) content of about between 0.50 and 50.0 milligrams per serving and magnesium in an amount of about 10-500 milligrams per serving (claim 1), and
the composition of claim 1, further including: kelp, 5-100 mg; vitamin A as retinol or retinyl palmitate or acetate or beta-carotene, 500-10,000 iu; vitamin B 1, 0.5-100 mg; vitamin B2, 0.5-100 mg; vitamin B6, 0.5-100 mg; Vitamin B3, 0.5-250 mg; vitamin B5, 5-200 mg; Vitamin B12, 5-5,000 mcg as cyanocobalamin or methylcobalamin or hydroxocobalamin or adenosylcobalamin; folic acid or methyl-folate or folinic acid, 10-1,000 mcg; 25-1,000 mcg; non-GMO vitamin C, 25-1,000 mg; vitamin D3, 500-10,000 IU; vitamin E as d-alpha tocopherol or dl-alpha tocopheryl and/or mixed tocopherols and/or tocotrienols, 5-400 iu for alpha tocopherol and 5-500 mg for mixed tocopherols including gamma-tocopherol or the family of tocotrienols; boron as glycinate (as well as other organic or inorganic forms of the mineral), 0.5- 10 mg; copper as bisglycinate (as well as other organic or inorganic forms of the mineral), 0.1-3 mg; zinc as bisglycinate (as well as other organic or inorganic forms of the mineral), 2.5-50 mg; manganese as bisglycinate (as well as other organic or inorganic forms of the mineral), 0.5-5 mg; selenium as glycinate (as well as other organic or inorganic forms of the mineral), 10-200 mcg; molybdenum as glycinate (as well as other organic or inorganic forms of the mineral), 10-400 mcg; and chromium as nicotinate glycinate (as well as other organic or inorganic forms of the mineral), 10-1,000 mcg (claim 10). ‘609’ further claims the inclusion of tapioca syrup, palm oil, citric acid and soy and/or sunflower lecithin (claim 18).
‘844 claims an oral mucoadhesive dosage form comprising: a saccharide base and an active ingredient composition, wherein the saccharide base comprises tapioca syrup, palm oil, and sunflower lecithin and wherein the oral mucoadhesive dosage form adheres to the oral cavity and provides an extended mucoadhesive residence time, in order to maximize oral mucosal, small molecule absorption and achieve a mass range per dosage of 4.5-5.8 grams (claim 1), and wherein the active ingredient composition comprises a composition of a cannabinoid and a mineral chosen from the group consisting of magnesium, lithium, and zinc (claim 9), and further wherein the cannabinoid and mineral composition comprises an organic chelated form of magnesium, lithium, or zinc (claim 10), and further comprising a composition of vitamins and minerals (claim 11).
The difference between the instantly rejected claims and the claims of copending ‘207 is that the claim of copending ‘207 do not expressly claim inclusion of vitamins/minerals/ and/or phytochemicals such as a phytocannabinoid.
The difference between the instantly rejected claims and the claims of copending ‘609 is that the claim of copending ‘609 do not expressly claim including lithium, a terpene and/or phenolic compound.
The difference between the instantly rejected claims and the claims of copending ‘844 is that the claim of copending ‘844 do not expressly claim the specific vitamins/minerals and amounts.
DAVIS, NIETLING and WAN each teach/disclose vitamin/mineral/ phytochemical supplement compositions, as discussed above and incorporated herein by reference.
SETERNES teaches an oral pharmaceutical composition in unit dose form, each unit dose including a lipophilic drug substance within a soft, chewable gelled oil-in-water emulsion including hydrophilic drug substance such as lithium sulfate, as discussed above and incorporated herein by reference.
LOWE teaches inclusion of a phytocannabinoid, as discussed above and incorporated herein by reference.
HSIA teaches nutritional supplements to the human diet including kelp in an amount of 10 mg, as discussed above and incorporated here in by reference. WESTERLUND teaches dietary supplements including about 1 mg of boron, as discussed above and incorporated herein by reference.
HENDERSON teaches a comprehensive dietary supplement of bioavailable minerals, vitamins, among others, including minerals as amino acid chelates, as discussed above and incorporated herein by reference.
It would have been prima facie obvious before the effective filing date of the claimed invention that the instantly rejected claims are an obvious variant of the claims of copending ‘207, ‘609 and ‘844 because each of ‘207, ‘609 and ‘844 include a saccharide-base for delivery of a active agent which includes vitamins/minerals/phytochemicals, as suggested by the cited prior art. The skilled artisan would have been motivated to modify the claims of copending ‘207, ‘609 and ‘844 and produce the instantly rejected claim because it would have been prima facie obvious to include known nutritional vitamins/minerals/phytochemicals in the compositions of ‘207, ‘609 and ‘844 to form soft chew or gummy compositions for delivery of the same. Furthermore, the skilled artisan would have had a reasonable expectation of success in producing the invention of the instantly rejected claims because it would have required no more than an ordinary level of skill to produce a vitamin/mineral/phytochemical soft chew or gummy formulation.
This is a provisional obviousness-type double patenting rejection.
Conclusion
Claims 1-16 are pending and have been examined on the merits. The specification is objected to (antecedent basis), and Claim 16 is objected to. Claims 7-11, 13 and 16 are rejected under 35 U.S.C. 112(b); claims 1-5, 12, 14 & 15 is rejected under 35 U.S.C. 102(a)(1); claims 1-16 are rejected under 35 U.S.C. 103; and claims are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of copending Application Nos. 18/970,207; 18/976, 609; and 17/689,844. No claims allowed at this time.
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/IVAN A GREENE/Examiner, Art Unit 1619
/TIGABU KASSA/Primary Examiner, Art Unit 1619
Prosecution Insights