Prosecution Insights
Last updated: April 19, 2026
Application No. 18/555,567

EASY CHEW FORMULATIONS

Non-Final OA §102§103§112
Filed
Oct 16, 2023
Examiner
OH, TAYLOR V
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Glaxosmithkline Consumer Healthcare Holdings (Us) LLC
OA Round
1 (Non-Final)
81%
Grant Probability
Favorable
1-2
OA Rounds
2y 5m
To Grant
96%
With Interview

Examiner Intelligence

Grants 81% — above average
81%
Career Allow Rate
1415 granted / 1742 resolved
+21.2% vs TC avg
Strong +15% interview lift
Without
With
+15.3%
Interview Lift
resolved cases with interview
Typical timeline
2y 5m
Avg Prosecution
35 currently pending
Career history
1777
Total Applications
across all art units

Statute-Specific Performance

§101
0.4%
-39.6% vs TC avg
§103
33.6%
-6.4% vs TC avg
§102
19.5%
-20.5% vs TC avg
§112
37.3%
-2.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1742 resolved cases

Office Action

§102 §103 §112
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. Non-Final Rejection . The Status of Claims: Claims 1- 7, 9-25 and 27-3 1 are pending. Claims 1- 7, 9-25 and 27-3 1 are rejected. DETAILED ACTION 1. Claims 1- 7, 9-25 and 27-3 1 are under consideration in this Office Action. Priority 2 . It is noted that t his application is a 371 of PCT/US2022/027949 05/06/2022 PCT/US2022/027949 , which has a priority of 63185469 05/07/202 1. Drawings 3. None. IDS 4. The IDS filed on 1 0 /1 6 /2023 has been reviewed by the examiner. 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 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. 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 appl icant regards as his invention. Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. In claim 20, the term” including” of the phrase “s oluble fibers including psyllium husk, inulin, fenugreek fiber, wheat dextrin ” is recited. The term”including” can be confusing because the claim does not explain what kinds of “ s oluble fibers ” are excluded from the claim. The examiner recommends to replace it with another term. 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 5. Claim(s) 1- 4 , and 25 are rejected under 35 U.S.C. 102 (a)(2) as being anticipated clearly by Chau ( US 2018/021255 A1 ). Chau discloses a composition (soft bar) comprising maltitol syrup 65%, maltodextrin 9.89%, Palm Oil (Cisao 83-12) 1.5%, High Melting Palm Oil (Revel A) 1 %, Glycerin 1 %, rosemary extract flavour and others as shown in example 4 in the following: (see page 4 , example 4) ; glycerin as the humectant is in an amount in the range of 1-3% (see page 2 , a paragraph#0027). These are identical with the claims. Claim Rejections - 35 USC § 103 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. 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. 6 . Claims 1- 7, 9-25 and 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Chau ( US 2018/021255 A1 ) in view of Cherukuri ( US 2010/0010101 A1) and Wan et al (US 2021/0401736 A1) having a provisional; application No. 62/847,946 filed on May 15, 2019 . Applicant claims the followings: 1. (Original) A composition comprising: an edible oil comprising coconut oil, palm kernel oil, palm oil, sunflower oil, hemp seed oil or any combination thereof;an edible triglyceride comprising cocoa butter, mango butter, ghee, hydrogenated palm oil, or any combination thereof; a humectant comprising glycerin, polyethylene glycol, propylene glycol, sorbitol, xylitol, maltitol, or any combination thereof; and a binder comprising maltodextrin, sucrose, microcrystalline cellulose, pregelatinized starch, dextrose, lactose, or any combination thereof. 2. (Original) The composition of claim 1 comprising 0.0 1-16 wt.% edible oil. 3. (Currently Amended) The composition of claim 1 comprising 0.01- 30 wt.% edible triglyceride. 4. (Currently Amended) The composition of claim 1 comprising 2-15 wt.% humectant. 5. (Original) The composition of claim 4 comprising 0.01-7 wt.% polyethylene glycol. 6. (Original) The composition of claim 5, wherein the polyethylene glycol is PEG-400 to PEG-5000. 7. (Currently Amended) The composition of claim 1 comprising 20-70 wt.% of binder. 9. (Currently Amended) The composition of claim 1 further comprising one or more active pharmaceutical ingredients. 10. (Original) The composition of claim 9, wherein the active pharmaceutical ingredient comprises a pain or inflammation reducer, an antihistamine, a decongestant, a cough suppressant, a vitamin, a mineral, a biological active, a sleep aid, a stress-reducing aid, an energy and cognition aid, an Ayurveda supplement, an immunity supplement, a digestive aid, a joint supplement, a cannabinoid, a systemic natural, a nutritional agent, pharmaceutically acceptable salts thereof, or combinations thereof. 11. (Original) The composition of claim 10, wherein the pain or inflammation reducer comprises ibuprofen, naproxen, acetaminophen, salicylic acid, acetylsalicylic acid, ketoprofen, dexibuprofen, fenoprofen, dexketoprofen, flurbiprofen, oxaprozin, loxoprofen, diflunisal, etodolac, indomethacin,ketorolac, oxaprozin, piroxicam, salsalate, salicylic acid, indomethacin,tolmetin,sulindac, etodolac,ketordolac, diclofenac, aceclofenac, bromfenac, pharmaceutically acceptable salts thereof, orcombinationsthereof. 12. (Currently Amended) The composition of claim 10, wherein the antihistamine comprises cetirizine hydrochloride, levocetirizine hydrochloride, loratadine, desloratadine, fexofenadine hydrochloride, azelastine hydrochloride, olopatadine hydrochloride, brompheniramine maleate, chlorcyclizine hydrochloride, chlorpheniramine maleate, dexbromphenirarnine maleate, dexchlorpheniramine maleate, diphenhydramine citrate, diphenhydramine hydrochloride, doxylamine succinate, phenindamine tartrate, pheniramine maleate, pyrilamine maleate, thonzylamine hydrochloride, triprolidine hydrochloride, pharmaceutically acceptable saltsthereof, orcombinationsthereof. 13. (Currently Amended) The composition of claim 10, wherein the decongestant or cough suppressant comprises phenylephrine hydrochloride, pseudoephedrine hydrochloride, pseudoephedrine sulfate, phenylephrine bitartrate, dextromethorphan, pholcodine, codeine, benzonatate, pharmaceutically acceptable salts thereof, or combinations thereof. 14. (Currently Amended) The composition of claim 10, wherein the vitamin, mineral, or biological active comprises vitamin A, vitamin B, vitamin C, vitamin D,vitamin E, vitamin K, thiamin, riboflavin, niacin, folate, biotin, panthothenic acid, iron, phosphorus, iodine, copper, chromium, molybdenum, chloride, sodium, magnesium, calcium, zinc, selenium, manganese, potassium, choline, lycopene, lutein, L-threanine, coenzyme Q-10,phytosterolshyaluronic acid, cognizing citicoline, silicon, icotinamide, Andrographis, pharmaceutically acceptable salts thereof, or combinations thereof. 15. (Currently Amended) The composition of claim 10, wherein the sleep aid comprises melatonin, lemon balm, lavender, chamomile, sage, valerian root extract, hops, passionflower extract, or combinations thereof. 16. (Currently Amended) The composition of claim 10, wherein the stress-reducing aid comprising sage, Ashwagandha (Withania somnifera), St. John's Wort, GABA (gamma-Aminobutyric acid), or combinations thereof. 17. (Currently Amended) The composition of claim 10, wherein the energy and cognition aid comprising green tea, ginseng, caffeine, rhodiola extract, B-vitamins, L-theanine, taurine, pharmaceutically acceptable salts thereof, or combinations thereof. 18. (Currently Amended) The composition of claim 10 ,wherein the Ayurveda supplement comprises amla (Emblica officinalis), bibhitaki (Terminalia bellirica), haritaki (Terminalia chebula)), Brahmi, cumin, licorice root, Gotu kolay, Cardamom, or combinations thereof. 19. (Currently Amended) The composition of claim 10, wherein the immunity supplement comprises copper, silver, spirulina, astragulus, beta glucan, aceola cherry extract, blood orange extract, elderberry, mushrooms (Lions Mane, Reishi, Shiitake, Cordyceps), pharmaceutically acceptable salts thereof, or any combinations thereof. 20. (Currently Amended) The composition of claim 10, wherein the digestive aid comprises a probiotic and combinations thereof; digestive enzymes; soluble fibers including psyllium husk, inulin, fenugreek fiber, wheat dextrin; Cascara sagrada; aloe ferox leaves extract, slippery elm bark extract, or combinations thereof. 21. (Currently Amended) The composition of claim 10, wherein the joint supplement comprises collagen, glucosamine, turmeric, methylsulfonylmethane (MSM), pharmaceutically acceptable salts thereof, or combinations thereof. 22. (Currently Amended) The composition of claim 10, wherein the cannabinoid comprises cannabidiol, cannabigerol, pharmaceutically acceptable salts thereof, and combinations thereof. 23. (Currently Amended) The composition of claim 10, wherein the systemic natural comprises one or more of Boswellia, curcumin, devils claw, ginger, feverfew, bromelain, turmeric, and butterbur. 24. (Currently Amended) The composition of claim 10, wherein the nutritional agent comprises black pepper, glycine, valerian root, eucalyptus, menthol, astragalus, bromelain, echinacea, white willow, ivy leaf (Hedera helix), ginger (Zingiberofficinale), pharmaceutically acceptable salts thereof, or combinations thereof. 25. (Currently Amended) The composition of claim 1 further comprising a solubility enhancer, a controlled release ingredient, a stabilizer, a taste masking ingredient, an antioxidant, a colorant, a plasticizer, a flavorant, a flow aid, or any combination thereof. 27. (Currently Amended) The composition of claim 25, wherein the flow aid comprises magnesium stearate, colloidal silicon dioxide, calcium stearate, stearic acid, glyceryl monostearate, glyceryl tribehenate, tricalcium phosphate, or any combination thereof. 28. (Currently Amended) The composition claim 27 comprising up to 3 wt.% of one or more flow aids. 29. (Currently Amended) The composition of claim 1, wherein the composition is a tablet. 30. (Original) The cornposition of claim 29, wherein the tablet has a hardness of less than 2 kp when tested with a conventional tablet hardness tester and a friability of less than 1.0% at 100 rotations. Determination of the scope and content of the prior art Chau discloses a chewable pharmaceutical composition (soft bar) comprising maltitol syrup 65%, maltodextrin 9.89%, Palm Oil (Cisao 83-12) 1.5%, High Melting Palm Oil (Revel A) 1 %, Glycerin 1 %, rosemary extract flavour and others as shown in example 4 in the following: (see page 4 , example 4) as in claims 1 -4, and 25 . Also, it teaches that t he bulking agent may be sugar-free, comprising one or more of: sorbitol, mannitol, xylitol, lactitol, maltitol, isomalt, erythritol, polydextrose, maltodextrin, gelatin, gum acacia, gum Arabic, carrageenan, locust bean gum, and guar gum. The lubricant may comprise palm oil, cocoa butter , sunflower oil, or combinations thereof (see page 1, a paragraph#0012) . Furthermore, it teaches that t he chewable pharmaceutical product may comprise by weight: (a) colesevelam hydrochloride as in claim 9 in an amount of 12.5%; (b) maltitol solids in an amount in the range of 52-54%; (c) one or more of: maltodextrin and gum acacia as the bulking agent totaling an amount in the range of 5-15%; (d) palm oil as the lubricant in an amount in the range of 1.5-6%; (e) glycerin as the humectant in an amount in the range of 1-3 % as in claim 4 ; (f) lecithin as the emulsifier in an amount in the range of 1-2%; (g) a flavoring in an amount in the range of 0.01-6%; (h) water in an amount in the range of 11.5-12.5% and (i) optionally one or more of a powdered sweetener, a coloring, and an antioxidant; wherein ingredients (a)-(i) total 100% (see page 2 , paragraphs# 0022-00 23) . The instant invention, however, differs from the prior art in that the claimed wt% range of binder , glucosamine, silicon dioxide , magnesium stearate , polyethylene glycol (PEG)400 -1000 , flow aids, bromelain or echinacea, ginger, St. John's wort, cannabidiol, glucosamine, soluble fibers, copper, licorice, caffeine, s age, vitamin C, an anti-inflammatory, acetaminophen, pseudoephedrine, chlorpheniramine maleate , the tablet having a hardness of less than 2 kp and a conventional tablet hardness tester and a friability of less than 1.0% at 100 rotations are not specified in the prior art. Cherukuri teaches chew-melt tablets comprising spray dried menthol (15 g), milled zinc acetate dehydrate (27.5 g), zinc gluconate (19.1 g), HPMC (5 g), Maltodextrin M180 (240 g), Sugar (346 g), mono and diglycerides (40 g), distilled mono and diglycerides (60 g), acetylated mono-diglycerides (70 g), polyethylene glycol, lecithin, eucalyptus oil (1.1 g), other flavors (20.5 g). After melting, the material is cooled and milled. The lubricants magnesium stearate (10 g), silicon dioxide (10 g), maltodextrin M180 (104.2 g), flavors (15 g), sweetener (1.25 g) and color agent (1.50 g) are added to the granular material and the product was compressed using conventional tablet press as in claim 29 (see page 20 , example 44) . Also, it teaches the p reparation of Compressed Rapid-Melt Product Containing Chondroitin and Glucosamine. 4.51 % cocoa butter . 9.01 % sorbitan monostearate. 0.45% lecithin. 0.36% polysorbate 20, 0.45% sodium lauryl sulfate. 0.02% color agent. 0.02% sucralose , 1.62% citric acid and 7.03% chondroitin sulfate were mixed in a heating vessel. The mixture was stirred and heated. Xylitol powder was added. The mixture was cooled. The mixture was milled using a colloidal mill . 24.61 % encapsulated glucosamine . 4.51% maltodextrin . 0.45% silicon dioxide . 0.90% magnesium stearate were mixed. The two mixtures were blended together and compressed (see page 12 , example 1). The lubricant may comprise any edible oil. Exemplary lubricants include but are not limited to: palm oil , cocoa butter, sunflower oil, or combinations thereof. Exemplary emulsifiers include but are not limited to: lecithin, distilled monoglycerides, mono-diglycerides, distilled propylene glycol monoester, succinylated monoglycerides, glyceryl monostearate, diacetyl tartaric acid esters of mono-diglycerides, glycerol lacto palmitates, (see page 12 , a paragraph#0053). In addition, the emulsifiers include p olyethoxylated fatty acids, e.g., polyethylene glycol (PEG) 400 distearate; PEG 100, 200, 300 mono­laurate; PEG 100, 200, 300 monooleate; PEG 400 d ioleate; PEG 400-1000 monostearate as in claim s 5 -6 (see page 4 , a paragraph#00 58 ). The rapid-melt compositions further contain a diluent/bulking material. The use of a diluent/bulking material is necessary to serve as a free-flow imparting agent as in claim 25 which aids in the moisturizing of the composition when chewed, that is, the diluent/bulking material aids in the processability of the compositions. The diluent/bulking material also serves to reduce the concentration of the active materials and add bulk to the composition. Examples of diluent/bulking materials useful in the compositions include, without limitation, silicon dioxide , sugars , starches, lactose, sucrose , sorbitol, fructose, talc, stearic acid , magnesium stearate , as in claims 27-28 , dicalcium phosphate and etc. (see page 5 , a paragraph#0077) , Examples of minerals that are available as active ingredients include, without limitation, calcium, magnesium, phosphorus, iron, zinc, iodine, selenium, potassium, copper , as in claim 19 , manganese, molybdenum and mixtures thereof (see page 8 , a paragraph#0113) . Examples of herbals that are available as active ingredients include, without limitation, echinacea , peppermint , l icorice , as in claim 18 , goldenseal, panax pseudoginseng. grapeseed extract, bilberry, kava, ginko biloba, panax quinquefolium, Siberian ginseng, St. John's wort as in claim 16 , bromelain, as in claim 24 , guglupids, hawthorn, garlic, ginger , as in claim 23 angelica species, dandelion, goldenseal, and mixtures thereof. Further, examples of spices that are available as active ingredients include, without limitation, mustard, dillweed, cinnamon, garlic, black pepper , as in claim 24 , onion, sage, as in claim 15 oregano, basil, cream of tartar, targon, cayenne pepper, red pepper (see page 8, a paragraph#0114). Also, high dose actives may be selected from a variety of therapeutic categories, and include, but not limited to the following: an analgesic; an anti-inflammatory as in claim 10 ; an antibiotic; an antiviral; an anti-irritability; a mineral, or a nutritional supplement, etc. Examples of specific drugs include: aspirin, acetaminophen, naproxen , as in claim 11 . balsalazide; mesalamine; ampicillin, amoxicillin; clavulanate; azithromycin, clarithromyin, abacavir, lamivudine, acyclovir, atazanavir, efavirenz, fosamprenavir, nelfinavir, ribavirin, saquinavir, and valacyclovir, or a combination thereof. Other examples include: calcium carbonate , glucosamine , as in claim 21 , chondroitin, Vitamin C as in claim 14 , guaifenesin, magnesium hydroxide, caffeine , as in claim 17 , loratadine, ibuprofeb, pseudoephedrine as in claim 13, diphenhydramine , chlorpheniramine maleate, as in claim 12 , cimetidine, ranitidine, famotidine, benzocaine, hexylresorcinol, zinc acetate, zinc gluconate, naproxen, naproxen sodium, codeine phosphate, hydrocodone, brompheniramine maleate, docusate sodium, bisacodyl, sennoside, multivitamins (vitamin A, B1, B2, B6, B12), Vitamin E, alone or in combination with another active agent. In some aspects, these active ingredients are encapsulated or coated with a functional or nonfunctional coating, which coated and/or encapsulated ingredients are then used in making the rapid melt compositions. Some nonlimiting examples include: encapsulated glucosamine, chondroitin, encapsulated phenylephrine , encapsulated acetaminophen, encapsulated vitamin C, encapsulated guaifenesin, encapsulated aspirin, calcium carbonate, magnesium hydroxide, or a mixture thereof. Examples of functional coating include enteric coating, pH-dependent coating, sustained release coating. Examples of nonfunctional coating include film coating and sugar coating (see page 8 , a paragraph# 0115). Preparation of Fiber 1.5 g and Phytosterols (2.0 g) Chewmelts Mono and diglyceride (40.00 g), distilled monoglycerides (80.00 g), lecithin (5.00 g) and acetylated mono-diglycerides (75.00) are added to the heating vessel. The mixture is heated up to 180.degree. F. and stirred well till it melts. Sigma mixer was preheated to temperature of 110.degree. F.-130.degree. F. and set to 60 RPM. The above molten mixture was transferred to the sigma mixer. Soluble fiber as in claim 20 e.g. Fibersol-2 (228.12) and phytosterols (412.39 g), and citric acid (12.00 g) (see page 19, example 41) Wan et al teaches a semi-solid chewable gel composition, comprising a gelling component in a sufficient amount to provide a cohesive gelled product, a cannabinoid component comprising cannabidiol, as in claim 22 and a complexing component (see abstract). Furthermore, the active composition may include herbal actives, hormones, or bioactive agents; the active composition includes caffeine, curcumin, gingerol, willow bark extract, salicylic acid, aspirin, or a combination thereof; the bioactive composition includes melatonin. In addition, the semi-solid chewable gel composition may further include sweeteners, food acids, flavoring agents, coloring agents, humectants, bulking agents, fatty acids, triglycerides, plasticizers, emulsifiers, thickeners, preservatives, or a mixture thereof (see page 9, paragraphs#0122-0123). Ascertainment of the difference between the prior art and the claims The difference between the instant application and the applied Chau art is that the Chau does not expressly teach the claimed wt% range of binder, glucosamine, silicon dioxide, magnesium stearate, polyethylene glycol (PEG)400, flow aids, bromelain or echinacea, ginger, St. John's wort, cannabidiol, glucosamine, soluble fibers, copper, licorice, caffeine, s age, vitamin C, an anti-inflammatory, acetaminophen, pseudoephedrine, chlorpheniramine maleate, tablet form and the tablet having a hardness of less than 2 kp and a conventional tablet hardness tester and a friability of less than 1.0% at 100 rotations . The deficiencies of the Chau are partially cured by the Cherukuri and Wan et al . The difference between the instant application and the applied Cherukuri art is that the C herukuri does not expressly teach the edible oil in % , humectant in % and cannabidiol and the tablet having a hardness of less than 2 kp and a conventional tablet hardness tester and a friability of less than 1.0% at 100 rotations . The deficiencies of the C herukuri are partially cured by the Chau and Want et al . The difference between the instant application and the applied Wan et al art is that the Wan et al does not expressly teach the claimed wt% range of humectant and wt% range of binder, glucosamine, silicon dioxide, magnesium stearate, polyethylene glycol (PEG)400, flow aids, bromelain or echinacea, ginger, St. John's wort, cannabidiol, glucosamine, soluble fibers, copper, licorice, caffeine, s age, an anti-inflammatory, acetaminophen, pseudoephedrine, chlorpheniramine maleate, tablet form and the tablet having a hardness of less than 2 kp and a conventional tablet hardness tester and a friability of less than 1.0% at 100 rotations . The deficiencies of the Wan et al are partially cured by the Chau and Cherukuri. Resolving the level of ordinary skill in the pertinent art . Regarding the Claim 7 with respect to the lack of disclosing the claimed wt% range of binder , the secondary reference, Cher u kuri does teach that the amount of binder is from about 10% to about 50% by weight (see page 9, a paragraph#0123) for the rapid-melt composition ; similarly, Chau does mention maltodextrin and gum acacia as the bulking agent (binder) totaling an amount in the range of 5-15% . From th ese , it is reasonable for the skilled artisan in the art to be able to increase the percentage of the binder in the mixture depending on the intended use since both prior art are closely related to each other with respect to a chewable or rapid-melt composition. Furthermore, the claimed ranges and prior art are overlapped with each other and one skilled artisan in the art would have expected them to have a similar condition in the absence of an unexpected result. So, if the skilled artisan the art had desired to increase the percentage of the binder in the composition for forming a particular composition , it would have been obvious to the skilled artisan in the art to be motivated to incorporate the teaching of CheruKuri ’s the % range of the binder into Chau composition to arrive at the claimed range of the binder in percent by a routine experimentation . Regarding the Claim 30 with respect to the lack of disclosing the tablet having a hardness of less than 2 kp and a conventional tablet hardness tester and a friability of less than 1.0% at 100 rotations, the prior art are silent about it. However, they are directly related to the physical properties of the tablet ; these are can be obtained naturally as a result of the evaluation of the tablet. Therefore, it does not have any patentable weight over the prior art. Considering objective evidence present in the application indicating obviousness or nonobviousness. Chau expressly discloses the chewable pharmaceutical composition (soft bar) comprising maltitol syrup 65%, maltodextrin 9.89%, Palm Oil (Cisao 83-12) 1.5%, High Melting Palm Oil (Revel A) 1 %, Glycerin 1 %, palm oil 1.5 %, and rosemary extract flavour and others. Similarly, Cherukuri does teach chew-melt tablets, which can contain the following various in gredients such as glucosamine, silicon dioxide, magnesium stearate, polyethylene glycol (PEG)400, flow aids, bromelain or echinacea, ginger, St. John's wort, cannabidiol, glucosamine, soluble fibers, copper, licorice, caffeine, s age, vitamin C, an anti-inflammatory, acetaminophen, pseudoephedrine, chlorpheniramine maleate and others. Furthermore, Wan et al does describe that the semi-solid chewable gel composition comprising cannabidiol can include sweeteners, food acids, flavoring agents, coloring agents, humectants, bulking agents, fatty acids, triglycerides, plasticizers, emulsifiers, thickeners, preservatives. All three references are closely related to one and another with respect to a chewable or rapid melt composition containing at least an edible oil , an edible triglycerides , a humectant , and a binder. Furthermore, Wan et al does offer guidance that c annabinoids can be for used for possible treatment of seizures, nausea, vomiting, lack of appetite, pain, arthritis, inflammation, neurological disorders, and other condition (see page 1, a paragraph#0007). So, if the skilled artisan in the art had desired to develop the chewable tablet containing a pharmaceutical composition containing c annabinoids and various active substances , it would have been obvious to the skilled artisan in the art before the effective filing date of the claimed invention to be motivated to incorporate the teachings of Cherukuri’s various active ingredients along with Wan’s c annabinoids into the Chau chewable composition in order to increase appetite for a subject in need as well as to improve the texture and taste of the formulated composition . This is because the skilled artisan in the art would expect such combined compositions to be successful and feasible as guidance shown in the prior art. 6. Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Chau ( US 2018/021255 A1 ) in view of Villagran et al (US 2017/0360865 A 1) . Applicant claims the following: 3 1. (Currently Amended) A composition comprising a tablet comprising:0.01-16 wt.%hydrogenated coconut oil; 0.01-14 wt.% cocoa butter; 2-15 wt.% glycerin; 0.01-7 wt.% polyethylene glycol; 20-70 wt.% maltodextrin and sucrose; and 0.1-3 wt.% flow aids, wherein the tablet has a hardness of less than 2 kp and a friability of less than 1.0% at 100 rotations. Determination of the scope and content of the prior art Cherukuri teaches chew-melt tablets comprising spray dried menthol (15 g), milled zinc acetate dehydrate (27.5 g), zinc gluconate (19.1 g), HPMC (5 g), Maltodextrin M180 (240 g), Sugar (346 g) ( 68.59 %) , mono and diglycerides (40 g), distilled mono and diglycerides (60 g), acetylated mono-diglycerides (70 g), polyethylene glycol (20 g) (1.98 %) , lecithin, eucalyptus oil (1.1 g), other flavors (20.5 g). After melting, the material is cooled and milled. The lubricants magnesium stearate (10 g), silicon dioxide (10 g ) (1.98 %) , maltodextrin M180 (104.2 g ), flavors (15 g), sweetener (1.25 g) and color agent (1.50 g) are added to the granular material and the product was compressed using conventional tablet press (see page 20, example 44) . Also, it teaches the p reparation of Compressed Rapid-Melt Product Containing Chondroitin and Glucosamine. 4.51 % cocoa butter . 9.01 % sorbitan monostearate. 0.45% lecithin. 0.36% polysorbate 20, 0.45% sodium lauryl sulfate. 0.02% color agent. 0.02% sucralose , 1.62% citric acid and 7.03% chondroitin sulfate were mixed in a heating vessel. The mixture was stirred and heated. Xylitol powder was added. The mixture was cooled. The mixture was milled using a colloidal mill . 24.61 % encapsulated glucosamine . 4.51% maltodextrin . 0.45% silicon dioxide . 0.90% magnesium stearate were mixed. The two mixtures were blended together and compressed (see page 12 , example 1). The instant invention, however, differs from the prior art in that the claimed composition comprising a wt% range of hydrogenated coconut oil , a wt% range of glycerin are unspecified in the prior art. Villagran et al teaches a soft chewable composition containing psyllium and other ingredients in the following: . (see page 20, a paragraph#0222) Ascertainment of the difference between the prior art and the claims The difference between the instant application and the applied Cherukuri art is that the Cherukuri does not expressly teach the claimed composition comprising a wt% range of hydrogenated coconut oil and a wt% range of glycerin and and the tablet having a hardness of less than 2 kp and a conventional tablet hardness tester and a friability of less than 1.0% at 100 rotations . The deficiencies of the Cherukuri are cured by the Villagran et al. The difference between the instant application and the applied Villagran art is that the Villagran does not expressly teach the claimed composition comprising a wt% range of cocoa milk, a wt% range of PEG and the tablet having a hardness of less than 2 kp and a conventional tablet hardness tester and a friability of less than 1.0% at 100 rotations. The deficiencies of the Villagran are cured by the Cherukuri. Resolving the level of ordinary skill in the pertinent art . Regarding the Claim 31 with respect to the lack of disclosing the claimed wt% range of hydrogenated coconut oil and wt% range of glycerin , the tertiary reference, Villagran does teach that the amount of hydrogenated coconut oil is 6 % by weight and the amount of glycerin is from 2.18 % to 3.08 % by weight (see page 20 , a paragraph#0 222 ) for the chewable composition . Therefore, those limitations do read on the claimed invention Regarding the Claim 3 1 with respect to the lack of disclosing the tablet having a hardness of less than 2 kp and a conventional tablet hardness tester and a friability of less than 1.0% at 100 rotations, the prior art are silent about it. However, they are directly related to the physical properties of the tablet ; these are can be obtained naturally as a result of the evaluation of the tablet. Therefore, it does not have any patentable weight over the prior art. Considering objective evidence present in the application indicating obviousness or nonobviousness. Cherukuri expressly teaches the chew-melt tablets comprising Maltodextrin M180 (240 g), Sugar (346 g )( 68.59 %), polyethylene glycol (20 g)(1.98 %), lecithin, eucalyptus oil (1.1 g), other flavors (20.5 g). After melting, the material is cooled and milled and the lubricants magnesium stearate (10 g), silicon dioxide (10 g )(1.98 %), maltodextrin M180 (104.2 g ), flavors (15 g), sweetener (1.25 g) and color agent (1.50 g) are added to the granular material and the product was compressed using conventional tablet press (see page 20, example 44); also, it does disclose the use of 4.51 % of cocoa butter in another composition . Similarly, Villagran et al teaches a soft chewable composition containing psyllium and other ingredients such as hydrogenated coconut oil ( 6%) and glycerin ( 2.18% to 3.08% ) (see page 20, a paragraph#0222) and other ingredients for the chewable composition. Both prior art are closely related to each other with respect to the chewable composition containing an edible oil , and an edible triglyceride and a humectant ,and a binder and flowing aids. So, if the skilled artisan in the art had desired to develop the chewable tablet composition containing hydrogenated coconut oil, cocoa butter, glycerin, polyethylene glycol, maltodextrin and sucrose; and flow aids with their corresponding specific amount in wt %, it would have been obvious to the skilled artisan in the art before the effective filing date of the claimed invention to be motivated to incorporate the teachings of Villagran ’s specific amount of each of hydrogenated coconut oil and glycerin excipients in wt% into Cherukuri composition in order to improve formulation texture and/or taste . This is because the skilled artisan in the art would expect such combined compositions to be successful and feasible as guidance shown in the prior art. Conclusion Claims 1- 7, 9-25 and 27-3 1 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT TAYLOR V OH whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-0689 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 8:00-5:00 . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Andrew Kosar can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-0913 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /TAYLOR V OH/ Primary Examiner, Art Unit 1625 3/29/2026
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Prosecution Timeline

Oct 16, 2023
Application Filed
Mar 29, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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1-2
Expected OA Rounds
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2y 5m
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