Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The Amendments filed on 1/17/2025 has been received and entered.
Currently, Claims 1-6, 8-9, 13-17, 19, 21-36, and 50-69 are pending. Claims 1-6, 8-9, 13-17, 19, 21-36, and 50-69 are examined on the merits.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Any rejection not reiterated below are hereby withdrawn.
Response to Amendment
Claim Objections
Claims 66-69 are objected to because of the following informalities: “target does” is suppose to be “target dose”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
Claim(s) 1, 2, 4, 5, 8, 9, 13, 14, 15, 16, 19, 23, 27, 28, 36 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Food and Wine (2020, https://web.archive.org/web/20200820054744/https://www.foodandwine.com/recipes/cannabis-infused-brioche-french-toast). This is not a new rejection, but with slight modification.
Food and Wine teaches stuffed French toast (toast is a food product made in a mold and baked) with Cannabutter and jam (a batch food product) soaked in a bowl with whisked eggs with cream, granulated sugar, browned on skillet then baked on a baking sheet (cooking). After all the toasts are baked, the French toasts are then topped with confectioners’ sugar, crème fraiche and strawberry jam, squeeze a little lemon juice and sprinkle with fleur de sel over each slice of French toast then served on a plate (How to Make It, Steps 1-4). Confectioners’ sugar, crème fraiche and strawberry jam, lemon juice and fleur de sel are not cooked before-hand with the food product. The plating of each French toast is individualized food product. Sugar is a biologically active product. The transferring to each plate would involve cooling down before toppings are put on top. Baking step would require the French toast be in a form of mold; thus, the limitation of Claim 13 is met. Two French toasts are required for stuffed French toast; thus, the limitation of 16 is met. Whisked eggs with cream would be viscous food product that flows into the molded French toast.
Claim Rejections - 35 USC § 103
Claim(s) 1-6, 8-9, 13-17, 19, 21-36, 50-59, and 63-69 are rejected under 35 U.S.C. 103 as being unpatentable over Hartman (2020, https://web.archive.org/web/20201118155400/https://cannigma.com/recipes/how-to-make-cannabis-gummies/) in view of Shabbyfufu (2020, https://web.archive.org/web/20200810152550/https://shabbyfufu.com/dried-edible-flowers-recipes/) and Leafly (2020, https://www.leafly.com/learn/growing/harvesting-marijuana/drying-curing-cannabis). This is not a new rejection, but with slight modification.
Hartman teaches a method of making cannabis gummies by using saucepan to heat coconut oil and cannabis for about an hour then strain and bottle up the batch (page 5, paragraphs 1-3). This is one cooking step and cooling step. On a stove, add water, cannabis coconut oil, and soy lecithin to a pot to simmer, then add gelatin and whisk until dissolved. This is a providing step to define a mixture of food product. Fill gummy molds one by one, freeze for 20-25 minutes to produce weed gummies (page 6, paragraphs 1-2). This is molding step. After bottling, the oil will be cooled. Each gummy is a portioned size. Cannabis is derived from marijuana. Cannabis coconut oil would inherently contain cannabinoid and flavonoids. Dosing is before the cooling step because the whole ingredient is cooked, then cooled. Gummies are a cooked viscous food product that flows into molds.
However, Hartman does not teach adding API after the product is made, encapsulating, packing the product, within 5% API dose.
Shabbyfufu teaches dried edible flowers are great for decorating baked goods (page 1).
Leafly teaches dried, cured marijuana buds can help preserve and accentuate flavors by retaining terpenes and cannabinoids (page 1).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to make cannabis gummy and adding more cannabis because Shabbyfufu teaches dried edible flowers are great for decorating baked goods (page 1). Leafly teaches dried, cured marijuana buds can help preserve and accentuate flavors by retaining terpenes and cannabinoids (page 1). One would have been motivated to make gummy candies for the expected benefit of accentuating its flavors with cannabinoids in baked goods. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
The reference also does not specifically teach formulating the composition in the forms claimed by applicant as a package and encapsulated. These pharmaceutical forms are well known in the art to be acceptable means of administering a pharmaceutically active substance. Based on this knowledge, a person of ordinary skill in the art would have had a reasonable expectation that formulating the composition taught by the references in the claimed forms would be successful. Therefore, an artisan of ordinary skill would have been motivated to formulating the composition taught by the reference in the forms claimed by applicant.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to make a composition comprising within 5% API dose of the active agent for the following reasons. The reference does teach the method for making cannabis gummies. Hartman teaches a method of making cannabis gummies by using saucepan to heat coconut oil and cannabis for about an hour then strain and bottle up the batch (page 5, paragraphs 1-3). This is one cooking step and cooling step. On a stove, add water, cannabis coconut oil, and soy lecithin to a pot to simmer, then add gelatin and whisk until dissolved. This is a providing step to define a mixture of food product. Fill gummy molds one by one, freeze for 20-25 minutes to produce weed gummies (page 6, paragraphs 1-2). Thus, it would have been obvious to make a concentrated composition containing API for use as a supplement to the diet. Additionally, the amount of a specific ingredient in a composition that is used for a particular purpose (the composition itself or that particular ingredient) is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus, optimization of general conditions is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, especially within the ranges taught by the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
Claim(s) 1-6, 8-9, 13-17, 19, 21-36, 50-59, and 62-69 are rejected under 35 U.S.C. 103 as being unpatentable over Hartman (2020, https://web.archive.org/web/20201118155400/https://cannigma.com/recipes/how-to-make-cannabis-gummies/) in view of Shabbyfufu (2020, https://web.archive.org/web/20200810152550/https://shabbyfufu.com/dried-edible-flowers-recipes/) and Leafly (2020, https://www.leafly.com/learn/growing/harvesting-marijuana/drying-curing-cannabis) as applied to claims 1-6, 8-9, 13-17, 19, 21-36, 50-59, and 63-64 above, and further in view of Seattle Gummy Company (2020, https://www.prnewswire.com/news-releases/seattle-gummy-company-secures-the-first-ind-gummy-drug-approval-from-fda-301152851.html). This is not a new rejection, but with slight modification.
The teachings of Hartman, Shabbyfufu and Leafly are set forth above and applied as before.
The combination of Hartman, Shabbyfufu and Leafly do not specifically teach the over-the counter drug and prescription drugs.
Seattle Gummy Company teaches the incorporation of various drug compounds into a novel gummy matrix, thus solving drug solubility, stability, and taste issues, specifically prescription drugs with the initial focus on antibiotics and cardiology medications, (page 2, paragraph 1) and a range of performance-focused gummies including caffeine, beauty, and sports gummies (over-the counter drugs).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to incorporate over-the counter and prescription drugs because Seattle Gummy Company teaches the incorporation of various drug compounds into a novel gummy matrix, thus solving drug solubility, stability, and taste issues. One would have been motivated to make prescription and over the counter drugs in a gummy for the expected benefit of easier solubility, stability or taste. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
Claim(s) 1-6, 8-9, 13-17, 19, 21-36, 50-69 are rejected under 35 U.S.C. 103 as being unpatentable over Hartman (2020, https://web.archive.org/web/20201118155400/https://cannigma.com/recipes/how-to-make-cannabis-gummies/) in view of Shabbyfufu (2020, https://web.archive.org/web/20200810152550/https://shabbyfufu.com/dried-edible-flowers-recipes/), Leafly (2020, https://www.leafly.com/learn/growing/harvesting-marijuana/drying-curing-cannabis), and Seattle Gummy Company (2020, https://www.prnewswire.com/news-releases/seattle-gummy-company-secures-the-first-ind-gummy-drug-approval-from-fda-301152851.html) as applied to claims 1-6, 8-9, 13-17, 19, 21-36, 50-59, 62-64 above, and further in view of Le Compte (2020, https://toakchocolate.com/blogs/news/can-dark-chocolate-enhance-the-functional-benefits-of-cbd-and-improve-your-endocannabinoid-tone). This is not a new rejection, but with slight modification.
The teachings of Hartman, Shabbyfufu, Leafly, and Seattle Gummy Company are set forth above and applied as before.
The combination of Hartman, Shabbyfufu, Leafly, and Seattle Gummy Company do not specifically teach chocolate and hard candy.
Le Compte teaches chocolate inhibits the breakdown of cannabinoids such as CBD and THC (page 3, last paragraph).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to add chocolate to the cannabinoid gummy because Le Compte teaches chocolate inhibits the breakdown of cannabinoids such as CBD and THC (page 3, last paragraph). One would have been motivated to make a cannabinoid gummy with chocolate for the expected benefit of stabilizing and prolonging the half-life of cannabinoids. Absent evidence to the contrary, there would have been a reasonable expectation of success in making the claimed invention from the combined teachings of the cited references.
The reference also does not specifically teach formulating the composition in the forms claimed by applicant as a hard candy. These pharmaceutical forms are well known in the art to be acceptable means of administering a pharmaceutically active substance. Based on this knowledge, a person of ordinary skill in the art would have had a reasonable expectation that formulating the composition taught by the references in the claimed forms would be successful. Therefore, an artisan of ordinary skill would have been motivated to formulating the composition taught by the reference in the forms claimed by applicant.
Response to Arguments
Applicant argues that flowing viscous food is not taught.
In response to Applicant’s argument, the whisked eggs with cream would be a viscous food product that flows into the molded French toast.
Applicant argues that there is no motivation to combine Shabbyfufu.
In response to Applicant’s argument, Shabbyfufu teaches dried edible flowers are great for decorating baked goods (page 1). Leafly teaches dried, cured marijuana buds can help preserve and accentuate flavors by retaining terpenes and cannabinoids (page 1). Therefore, it would be obvious to use dried buds for decorating gummies or baked good. One of ordinary skill in the art would know how to combine dried cannabis buds into baked goods or gummies.
Applicant argues that administration of dose form is not obvious.
In response to Applicant’s argument, packaging is not a part of the invention. It is a part of keeping the food product clean and safe for commercial distribution. It would be obvious for one to package a food product for administration as individual packs or in encapsulated.
Applicant argues that the cooling step is not taught.
In response to Applicant’s argument, Hartman et al. teaches fill gummy molds one by one, freeze for 20-25 minutes to produce weed gummies (page 6, paragraphs 1-2). Freezing step would inherently mean cooling step because freezing would involved lowering of temperatures.
Applicant argues that successive layers is not taught.
In response to Applicant’s argument, the process of layering dried API material, chocolate addition would involve successive layering of API material. Candy can be made by successive layering of gummy, API, chocolate to form a layered product with API inside the candy.
Applicant argues that dosing the food product with API after molding the product is not taught.
In response to Applicant’s argument, Shabbyfufu teaches dried edible flowers are great for decorating baked goods (page 1). Leafly teaches dried, cured marijuana buds can help preserve and accentuate flavors by retaining terpenes and cannabinoids (page 1). The addition of decorations with dried marijuana buds to gummies would be dosing after molding. It would be obvious to increase dosage by adding API after the product is made.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERYNE CHEN whose telephone number is (571)272-9947. The examiner can normally be reached Monday-Friday 9-5:30 PM.
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Catheryne Chen Examiner Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655