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 .
The previous rejections made under 35 U.S.C. 112 (b) on claims 16 and 17, which were indicated in the Office action dated March 23, 2025, have been withdrawn in view of the amendment made to the rejected claims
All previous claim rejections made under 35 U.S.C. 102 or 103 have been withdrawn in view of the amendment made to claim 1 which quires the saccharide base comprise tapioca syrup, palm oil and sunflower lecithin.
New rejections have been made to address the amended claims as following:
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.
Claims 1, 5-8, 15-17, 20, 22-23, 25, 26 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Stoll (US 2013030929 A1, published on November 21, 2013) in view of Ummadi et al. (US 20130122176 A1, published on May 16, 2013) (“Ummadi” hereunder).
The amended claim 1 is directed to 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.
Stoll disclose a caramel candy formulation comprising 40wt % tapioca syrup, 0.17 wt % soy lecithin (emulsifier) and 12 wt % palm kernel oil and a vitamin mixture as an active ingredient composition. See Example 7, Table 6. As there is no specific definition or limitation of the term “a saccharide base” in the present claim 1, the disclosed caramel formulation as whole which comprises tapioca syrup, lecithin and the vegetable oil is considered as the saccharide base. The reference teaches that caramels remain tacky, which indicates that the composition is mucoadhesive and adheres to the oral cavity.
Although Stoll uses soy lecithin, it is well known in confectionary art that soy lecithin and sunflower lecithin are both useful as natural emulsifiers. Ummadi teaches and suggests that either lecithin can be used as an emulsifier in making confectionary products. See [0050]. Substituting art-recognized functional equivalents known for same purpose is prima facie obvious. See MPEP 2144.06. In this case, since Ummadi establishes that soy lecithin and sunflower lecithin are natural emulsifiers used in making confectionary, substituting soy lecithin in the Stoll caramel composition with sunflower lecithin to make a similar product would have been prima facie obvious before the effective filing date of the present application.
Although palm kernel oil is used, Stoll teaches that both palm oil and palm kernel oil are conventionally used in confectionary art; the reference further teaches that vegetable oils are used as humectants to provide a perception of mouth hydration and moistening;. See [0043], [0064]. Substituting art-recognized functional equivalents known for same purposes is prima facie obvious. See MPEP 2144.06. In this case, since Stoll establishes that palm kernel oil and palm oil are humectant oils useful in confectionary art, using palm oil in place of palm kernel oil as a hydrating agent would have been prima facie obvious.
Regarding claim 5, Stoll teaches a size of one piece of a chew is 2.5 grams, while a single serving size consisting of a plurality of pieces is about 20-60 grams. Changes in size/proportion is prima facie obvious. See MPEP 2144.04, IV, A; see also In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955) (Claims directed to a lumber package "of appreciable size and weight requiring handling by a lift truck" were held unpatentable over prior art lumber packages which could be lifted by hand because limitations relating to the size of the package were not sufficient to patentably distinguish over the prior art.); In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) ("mere scaling up of a prior art process capable of being scaled up, if such were the case, would not establish patentability in a claim to an old process so scaled." 531 F.2d at 1053, 189 USPQ at 148.). In the present case, modifying the amount of the composition to make the same product in various sizes would have been prima facie obvious.
Regarding claim 6, the caramel candy ingredients in Stoll include water, which is inert and inactive ingredient and may be considered as an excipient. See Table 6.
Regarding claim 7, the candy formulation contains evaporated cane juice and sweetened condensed milk, which are considered sweeteners.
Regarding claim 8, Stoll teaches and suggests using natural colorants. See [0048].
Regarding claim 15, Stoll teaches adding medicaments, nutrients including mineral supplement in the confectionary; magnesium and zinc are particularly mentioned. See [0022].
Regarding claims 16 and 17, Stoll disclose a caramel candy formulation comprising 40wt % tapioca syrup, 0.17 wt % soy lecithin (emulsifier) and 12 wt % palm kernel oil. See Example 7, Table 6.
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.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this case, Stoll teaches that tapioca syrup provides a sweetness, body and humectancy that is similar to high fructose corn syrup and is hypoallergenic. See [0116]. Lecithin and vegetable oils are useful as an emulsifier and a hydrating agent for mouthfeel, respectively. As the functions of these components are well known, adjusting the amounts and finding optimal concentrations by routine experimentations to make a stable confectionary with optimal sweetness and hydrating effects would have taken no more than ordinary skill in the art.
Regarding claim 20, Stoll teaches that the confectioneries according to the invention can include center-fill compositions comprising probiotic materials, vitamins/minerals, etc. See [0098]. It would have been obvious to incorporate probiotic materials, which are considered “fermenting organisms”, in the caramel candy as taught and suggested by the teachings of the reference.
Regarding claims 22-23 and 28, since the reference teaches that the composition is suitable to deliver a wide range of pharmaceutical agents, and as adjusting the dosage would be well within one of ordinary skill in the art, making a composition suitable for different patient groups would have been prima facie obvious before the effective filing date of the present application. Regarding claim 28, there is no teaching or suggestion in the reference that the disclosed formulation would be unsuitable for use in subjects with neurological disorders.
Regarding claim 25, Stoll teaches that the center-fill composition may include may be sugar-free, which would be suitable for diabetic subjects. See [0094].
Claims 9, 14, 21 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Stoll and Ummadi as applied to claims1, 5-8, 15-17, 20, 22-23, 25, 26 and 28 above, and further in view of Koch et al. (US 20150336874 A1, published on November 26, 2015, previously cited) (“Koch” hereunder).
Stoll teaches adding medicaments, nutrients including micronutrients and mineral supplement in the confectionary; magnesium and zinc are particularly mentioned. Stoll fails to teach cannabinoids. See [0097]
Koch teaches that cannabinoids such as cannabidiol (CBD) and cannabinol (CBN) are provided in various pharmaceutical dosage forms, including foodstuff, gourmet or snack preparation for consumption. See abstract; [0071, 0018]. The reference teaches that cannabinoids are useful in therapeutic treatment of the human or animal body to achieve appetite-stimulating effect, anti-emetic effect, reduction of muscular cramps and spasticity, alleviation of pain, etc. See [0003].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Stoll and incorporate to the composition cannabidiol or cannabinol as motivated by Koch. The skilled artisan would have been motivated to do so, as 1) both references teach foodstuff as a vehicle to deliver therapeutic agents; and 2) Koch teaches the specific therapeutic efficacy and functions of the cannabinoids. Since Stoll invites one of ordinary skill in the art to add a wide range of therapeutic agents, the skilled artisan would have had a reasonable expectation of successfully producing a confectionery product comprising CBD or CBN as well as vitamins and minerals.
Regarding claim 21, Koch teaches that cannabinoids such as delta-9-THC is useful in treating nausea and emesis associated with chemotherapy in cancer patients. See [0022]. Thus, it is obvious that the Stoll composition comprising such cannabinoid would be capable and suitable for such use.
Regarding claim 27, Koch teaches that cannabinoids are useful in therapeutic treatment including alleviation of pain; the dosage form made according to the combined teachings of the references would be obviously suitable for use in administering the cannabinoids that can be used as pain killers. See [0003].
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Stoll, Ummadi and Koch as applied to claims 1, 5-9, 14-17, 20-23 and 25-28 above, and further in view of Harper (US 20160333411 A1, published on November 17, 2016, previously cited).
Although Stoll teaches using vitamins and minerals in general, the reference fails to teach the specific compositions as described in the present claims.
Regarding claim 10, Harper teaches that zinc is provided from TRAACS® in the form of zinc glycinate chelate. See [0181]. Thus, given the teachings in Stoll to incorporate vitamins and minerals, making a Stoll composition with a chelated zinc to make a zinc supplement would have been prima facie obvious. See also present claim 11.
Regarding claim 12, Stoll teaches that the vitamin premix contains 100% of US recommended daily dosage of vitamin s B1, B2, B3, B5 and B6 per 1.41 gram. Since the caramel confection in Table 6 contains 1.78 grams of the premix, the disclosed formulation contains about 126% of these vitamins.
Claims 13 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Stoll, Ummadi, Koch and Harper as applied to claims 1, 5-12, 14-17, 20-23 and 25-28 above, and further in view of Sole et al. (US 6232346 B1, published on May 15, 2001, previously cited) (“Sole hereunder).
Stoll teaches adding medicaments, nutrients including micronutrients such as coenzyme Q10, L-carnitine, etc, in the confectionary; the reference fails to teach the specific amounts of the nutrients as defined in the present claims.
Sole teaches that coenzyme Q10 can be administered in an amount of 15 mg/kg/day or 75 mg in a supplement; coenzyme Q10 is a major endogenous lipophilic antioxidant and can regenerate a-tocopherol by reducing the a-tocopherol radical. The reference teaches that coenzyme Q10, ubiquinone, is critically necessary for oxidative energy production, which is important for cardiac function.
Regarding claim 13, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Stoll and incorporate to the supplemental mixture 75 mg of coenzyme Q10 as motivated by Sole. The skilled artisan would have been motivated to do so, as the latter teaches and suggests the effective amount of coenzyme Q10 to function as an antioxidant beneficial for cardiac function. Since Stoll teaches to add coenzyme Q10 in its supplement mixture, the skilled artisan would have had a reasonable expectation of successfully combining the teachings of the references and producing a stable confectionary formulation which provide health benefits to heart.
Regarding claim 19, Sole further teaches that taurine is an essential amino acid and taurine supplementation has shown to help in heart failure, improve cardiac function and acts as an osmoregulatory and neuromodulator in the brain, offering protective effects against hypoxia, seizures, and diabetic renal dysfunction, etc. See col. 5, line 28 – col. 6, line 64. Sole teaches that taurine can be administered 188 mg/day in a cardiac cocktail or 1.5 g in a supplement. See Example 1; Fig. 6A.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to modify the teachings of Stoll and incorporate to the supplemental mixture 188 mg of taurine as motivated by Sole. The skilled artisan would have been motivated to do so, as the latter teaches and suggests the expected benefits of taurine, the skilled artisan would have been obviously motivated to combine the teachings of the references with a reasonable expectation of successfully producing an improved nutritional supplement beneficial to heart or brain health by combining the teachings of the references.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Stoll, and Ummadi as applied to claims 1, 5-8, 15-17, 20, 22-23, 25, 26 and 28 above, and further in view of Sengupta et al. (US 20140081065 A1, published on March 20, 2014) (“Sengupta” hereunder).
Although Stoll generally teaches using vegetable oils for hydrating and moisturizing agent, and using omega-6 fatty acids as a micronutrient, the reference fails to specifically mention oleic acid and linoleic acid.
Sengupta teaches that palm oil typically includes about 37 wt % of oleic acid and about 9 wt % of linoleic acid. See [0053]. As indicated above, Stoll renders the caramel composition comprising palm oil obvious; such composition comprising 10 wt % of palm oil, for instance, would inherently contain about 3.7 wt % of oleic acid and about 0.9 wt % of linoleic acid.
Oath/Declaration
The Declaration filed under 37 C.F.R. 1.132 on September 23, 2025 has been fully considered but does not place the application in allowable condition.
According to the declaration, the biotin absorption from a product which is representative of the present invention, (“HempMag” chews) was compared to absorption of the same active in a conventional multivitamin gummy (“Olly”) and a multivitamin capsule (“BrainMD”). The Olly formulation contains glucose syrup, gelatin, and coconut and canola oil.
It was found that the participants who received HempMag experienced a 260% increase in blood biotin levels 15 minutes after administration, whereas the Olly multivitamin group only experienced a 2.35 % increase after 15 minutes. As for HempMag, the area under curve (AUC) at two hours was 148 ng/mL, whereas the Olly multivitamin experienced 93.2 ng/mL.
As for the comparison between HempMag and the BrainMD capsule, it was found that the HempMag participants experienced a 356 % increase in blood biotin levels 15 minutes after administration, while the BrainMD capsule group experienced only a 50 % increase.1 The AUC at two hours for the HempMag group was calculated to be 218 ng/mL over 2 hours, while the BrainMD group experienced 107 ng/mL over 2 hours.2
Declarant/Inventor states that other water-soluble small molecule active ingredients in applicant’s invention formulation would also exhibit similar fast and substantial absorption and higher bioavailability. Declarant also states that the HempMag oral formulation contains “tapioca syrup, palm oil (containing two powerful permeation enhancers, linoleic acid and oleic acid), cane sugar, and sunflower lecithin (also containing the aforementioned permeation enhancers).” As indicated in the above rejection made under 35 U.S.C. 103 over Stoll, the reference teaches a caramel confectionary formulation containing palm kernel oil and soy lecithin. According to Sengupta, palm kernel oil in the original Stoll caramel formulation and palm oil similarly contain about 37 wt % oleic acid and about 9 wt % linoleic acid. See [0053]. Lecithin, whether it is derived from soy or sunflower, contains phospholipids, which are believed to function as the permeation enhancer. See US 20190255014 A1, [0004]. Thus, if the superior absorption properties of the present invention are attributable to the presence of oleic acid, linoleic acid and phospholipids, one of ordinary skill in the art would have also expected that the Stoll’s original formulation in Table 6 comprising palm kernel oil and soy lecithin and the present invention would exhibit similar absorption rates of bioavailability of active ingredients. As indicated in the rejection above, modifying the Stoll’s original formulation to arrive at the present invention would have been prima facie obvious. The examiner views that the Stoll’s original formula comprising tapioca syrup, soy lecithin and palm kernel oil in similar concentration ratio is the closest prior art, and there is no evidence to show that applicant’s invention produces greater than expected results over what is known in the art.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 5-23 and 25-28 have been considered but are moot in view of the new grounds of rejections.
Applicant’s arguments regarding unexpected results have been addressed above Oath/Declaration.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA JUSTICE whose telephone number is (571)272-8605. The examiner can normally be reached M-F 9:00 AM - 5 PM.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617
1 On p. 12 of the declaration, the second table indicates that the data is from “Olly Participants”. However, since the comparison is between HempMag Super Immunity and BrainMD Neurovite Plus capsule formulation, it appears that data is from “BrainMD” participants. Clarification is required.
2 Similarly, on p. 13, paragraph 33, Declarant mentions the Olly multivitamin. Clarification is required. Examiner assumes that the comparison was made against BrainME capsules.