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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04 August 2026 has been entered.
Formal Matters
Applicant’s claim amendments and arguments in the reply filed on 04 August 2026 are acknowledged and have been fully considered due to the entered request for continued examination. Claims 1, 3-4, and 6-14 are pending. Claims 1, 3-4, and 6-14 are under consideration in the instant office action. Claims 2, 5, and 15-16 are canceled.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
New Rejections-Necessitated by Amendment
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 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.
Note: The claims were examined with respect to the elected species of a) a reactive couple comprising a carboxylic acid and a carbonate or bicarbonate as the effervescent component, the effervescent composition comprises a sugar alcohol as a filler, and nicotine as the first active agent; and election of b) the non-effervescent composition comprises a sugar alcohol as a filler, a cellulose ether as a binder, and nicotine as the second active agent. However, Applicant in the current amendment changes the first and second active agents to caffeine and make an amendment reciting the multilayered tablet is completely free of nicotine.
Claims 1 and 6-14 are rejected under 35 U.S.C. 103 as being unpatentable over ANDEUREASEU et al. (EP 2233134, previously cited) in view of Schobel (US Patent No. 4,687,662, previously cited) and Vepuri et al. (US 2016/0128943, newly cited).
Applicants’ claims
Applicant claims “A multi-layered tablet configured for oral use, the tablet comprising a first layer comprising an effervescent composition and a second layer comprising a non-effervescent composition, wherein: the effervescent composition comprises an effervescent material capable of causing effervescence in the oral cavity, the effervescent material comprising an acid component and a base component, wherein the effervescent material has a particle size as measured by sieve analysis from about 30 to about 180 µm; one or more fillers in a total amount of at least about 30% by weight, based on the total weight of the effervescent composition, wherein the one or more fillers include at least one sugar alcohol; and a first active ingredient comprising caffeine; and the non-effervescent composition comprises one or more fillers in a total amount of at least about 30% by weight, based on the total weight of the non-effervescent composition, wherein the one or more fillers include at least one sugar alcohol; a cellulose ether binder; and a second active ingredient comprising caffeine, wherein the multi-layered tablet is completely free of tobacco material or comprises less than 0.1% by weight of tobacco material and is completely free of nicotine.”
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
ANDEUREASEU et al. teach a multi portion intra-oral dosage form comprising at least one pharmaceutically active agent or health promoting agent wherein at least one portion comprises a component for creating a noticeable organoleptic sensation. Of certain interest is use of sensory markers/signals as conceptual aids for a subject using the dosage form whereby the organoleptic sensation/s is/are such that it/they facilitate/s for the subject to identify a portion and differentiate between different portions thereof (abstract). ANDEUREASEU et al. teach a multi portion intra-oral dosage form comprising at least one pharmaceutically active agent or health promoting agent, wherein there is a discernable difference in organoleptic sensation between at least two portions, where preferably the organoleptic sensation/s is/are related to perception of flavor, effervescence, olfactory sensation, viscosity, elasticity, rheology, texture, mouth feel and difference in disintegration rate (see claim 1). A multi portion intra-oral dosage form according to claim 1, where the portions have different disintegration rates (see claim 2). A multi portion intra-oral dosage form according to claim 2, wherein at least one more rapidly disintegrating portion comprises a compressible excipient selected from isomalt, dextrose monohydrate, maltodextrin, lactose monohydrate, dextrin, mannitol, lactitol, sorbitol, xylitol, erythritol, sucrose, and lactose, and mixtures or derivatives thereof; wherein preferably the at least one more rapidly disintegrating portion comprises from about 5 to about 90 percent by weight of one or more of the compressible excipients based on the total weight of the disintegrating portion, more preferably it comprises from about 15 to about 75 percent and most preferably it includes at least 40 percent by weight of the one or more compressible excipients (see claim 3). A multi portion intra-oral dosage form according to claim 3, where the compressible excipient is in the form of particles with an average particle diameter of about 5 to about 1500 microns more preferably with a particle size of 20 to about 1000 micron and most preferably with a particle size of 40 to 600 microns (see claim 4). A multi portion intra-oral dosage form according to claim 3 or claim 4, wherein the at least one more rapidly disintegrating portion further comprises a water-swellable excipient selected from sodium starch glycolate, crospovidone, croscarmellose, microcrystalline cellulose, starches, hydroxypropyl cellulose, and alginic acid; wherein preferably the weight ratio of the compressible excipient to the water-swellable excipient is from about 1:1 to about 500:1 and more preferably 5:1 to about 500:1, and most preferably 10:1 to about 200:1 (see claim 5). A multi portion intra-oral dosage form according to claim 3 or claim 4, wherein the more rapidly disintegrating portion or portions further comprise(s) an effervescent couple comprising a member selected from the group consisting of sodium bicarbonate, potassium bicarbonate, calcium carbonate, magnesium carbonate, and sodium carbonate and one member selected from the group consisting of citric acid, malic acid, fumaric acid, tartaric acid, and alginic acid (see claim 6). A multi portion intra-oral dosage form according to any preceding claim, where each portion comprises at least one item selected from a component for treating tobacco dependence, a pharmaceutically active component, a nicotine mimicking component, a pH-buffering component, a pH-regulating component, a flavor, a barrier component, a color component, an adhesive component, a taste masking agent, a tooth whitening agent, a breath freshening agent, an oral health promoting agent, and an anti-caries agent (see claim 9). A multi portion intra-oral dosage form according to any preceding claim, being a lozenge, a tablet, an oral film, a chewing gum, a sublingual tablet, a troche, a lolly pop, a hard boiled candy, a chocolate lens, a micro bead, a wine gum, a semi solid, or a combination thereof (see claim 11). In one embodiment, a disintegrative tablet portion includes one or more effervescent couples. In one specific embodiment, the effervescent couple includes one member from the group consisting of sodium bicarbonate, potassium bicarbonate, calcium carbonate, magnesium carbonate, sodium carbonate and one member selected from the group consisting of citric acid, malic acid, fumaric acid, tartaric acid, phosphoric acid, alginic acid (paragraph 0090). In one embodiment, the combined amount of the effervescent couple(s) in the disintegrative tablet portion is from about 0.1 to about 20 percent by weight, such as from about 2 to about 10 percent by weight of the total weight of the disintegrative tablet portion (paragraph 0091). A rapidly dissolving tablet portion may include conventional ingredients, including other fillers, which include water-soluble compressible carbohydrates such as dextrose, sucrose, mannitol, sorbitol, maltitol, xylitol, lactose, and mixtures thereof; other conventional dry binders like polyvinyl pyrrolidone and the like; sweeteners such as aspartame, acesulfame potassium, sucralose, and saccharin; lubricants, such as magnesium stearate, stearic acid, talc, and waxes; preservatives; flavors; disintegrants, antioxidants; acidulants, such as but not limited to citric acid, malic acid, tartaric acid, ascorbic acid, and fumaric acid; surfactants; and coloring agents (paragraph 0092). A slowly dissolving portion or portions may comprise an excipient selected from, but not limited to, the group consisting of isomalt, sucrose, dextrose, dextrose monohydrate, corn syrup, lactitol, lycasin, mannitol, sorbitol, erythritol, xylitol, starches, gelatinized starches, maltodextrin, lactose, lactose monohydrate, dextrin, and mixtures and/or derivatives thereof. The slowly dissolving portion/s may comprise an excipient selected from but not limited to the group consisting of isomalt, sucrose, dextrose, corn syrup, lactitol, and lycasin, and mixtures and/or derivatives thereof (paragraph 0093). Especially the rapidly dissolving portion/s may comprise an effervescent couple comprising e g one member selected from the group consisting of sodium bicarbonate, potassium bicarbonate, calcium carbonate, magnesium carbonate, and sodium carbonate and one member selected from the group consisting of citric acid, malic acid, fumaric acid, tartaric acid, and alginic acid (paragraph 0094). The present invention may thus be employed in embodiments where for example, but not limited to, one or more pharmaceutically active and/or health promoting agent(s) is/are chosen from psychostimulant, for example caffeine; etc., (see paragraph 0058). Other additives may be added optionally to the oral formulation. Optional additives comprise at least one or more additives selected from the group consisting of solvents, such as ethanol and water; co-solvents, such as propylene glycol; stabilisers, such as preservatives, e g antioxidants; softeners, such as sorbitol and glycerine; thickening/flowability agents, such as colloidal silicon dioxide; binding agents, such as xanthan gum; filling agents, such as mannitol, isomalt, cocoa powder and Crospovidone; solubilizers, such as Polysorbat 80 and Atmos 300; rubbers, lipid barriers, such as sucrose fatty acid esters and hydrogenated vegetable oils; film forming agents, such as gelatine, Pullulan, carrageenan, pectin, locust bean gum and xanthan gum; emulsifiers, such as pectin, soy lecithin, glycerol monostearate, castor oil and poloxamer; glidants, such as colloidal silicon dioxide; lubricants, such as magnesium stearate; coating agents, such as castor oil and sorbitol; melting vehicles, such as vegetable oils; sweeteners, flavors, aromatics, cooling agents, enhancers, colouring agents, vitamins, minerals, fluorine, breath fresheners, tooth whitening agents and mixtures thereof. According to the invention, at least one of such additives is optionally added to the product (paragraph 0077). ANDEUREASEU et al. teach that in one embodiment, each portion of the multi portion intra-oral dosage form according to the invention comprises at least one item selected from a pharmaceutically active agent, a pH-buffering component, a pH-regulating component, a flavor, a barrier component, a color component, an adhesive component (which the examiner equates as binders), a taste masking agent, a health promoting agent e g a tooth whitening agent, a breath freshening agent, an oral health promoting agent, and an anti-caries agent, preferably the pharmaceutically active or health promoting agent is selected from an agent for treating tobacco dependence, such as nicotine, and a nicotine mimicking agent (see paragraph 0099). Therefore, the inclusion of a binder or an adhesive component in both layers is covered.
The examiner notes that the compositions of ANDEUREASEU et al. do not comprise tobacco materials and caffeine is one of the actives listed to be used in the formulation. If caffeine is utilized as one of the alternative active agents the formulation is free of nicotine. Nicotine is taught by ANDEUREASEU et al. as one type of active agent to be used by the formulation.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
ANDEUREASEU et al. do not specifically teach the limitation wherein the effervescent material comprising an acid component and a base component, wherein the effervescent material has a particle size as measured by sieve analysis from about 30 to about 180 mm. This deficiency is cured by the teachings of Schobel.
Schobel teaches effervescent compositions in the form of tablets or powders comprising a therapeutic agent, a granulating agent, a microparticulate effervescent component and an effervescent system which dissolve rapidly in water to yield an effervescent solution containing a completely dissolved therapeutic agent and a process for their preparation (see abstract). Schobel teaches a rapid dissolving therapeutic effervescent composition which comprises: (1) a preblended mixture present in an amount from about 7 to about 57.5% by weight of (A) a granulated therapeutic agent having a particle size of about 100 to about 600 microns, wherein the granulated therapeutic agent comprises a therapeutic agent present in an amount from about 2% to about 27% by weight selected from the group consisting of acetaminophen, aspirin, ibuprofen and mixtures thereof, and a water soluble granulating agent present in an amount from about 0.03 to about 2.5% by weight, being compatible with the therapeutic agent and having a viscosity below 100 cps, 10% by weight, at 25° C. in water, and (B) a component of an effervescent system having a particle size of about 50 to about 600 microns, present in an amount from about 5% to about 30% by weight said component being selected from the group consisting of a carbonate, an acid and mixtures thereof, and (2) an effervescent system present in an amount from about 42.5% to about 90% by weight wherein the effervescent system comprises a carbonate containing material and an acid, all percentages are by weight of the total effervescent composition (see claim 1). The effervescent system may comprise one or more components. The component of the effervescent system blended with the granulated therapeutic agent is in a microparticulate form having a particle size from about 50 to about 600 microns. In a preferred embodiment, the effervescent system comprises a carbonate containing material and an acid. The microparticulate component of the effervescent system may be the carbonate containing material, the acid and mixtures thereof (column 4, lines 48-56). Schobel teaches it is believed that the component of the effervescent system having a particle size of about 50 to about 600 microns because of its controlled particle size forms a uniform mixture with the granulated therapeutic agent which has about the same particle size. It is further believed that these particulate materials adhere to each other after mixing with the remaining components of the effervescent composition and that this property results in the formation of an extremely uniform effervescent composition which rapidly disintegrates in cold water dispersing the granulated therapeutic agent. It is believed that granulating prevents segregation of the therapeutic agent during mixing to form the effervescent composition and prevents agglomeration in solution after its release from the composition (column 2, lines 32-46).
ANDEUREASEU et al. do not specifically teach cellulose ether as a binder. This deficiency is cured by the teachings of Vepuri et al.
Vepuri et al. teach an oral formulation comprising: a first component providing for immediate or rapid release of caffeine, and a second component providing for extended release of caffeine, wherein the formulation provides a blood plasma concentration of caffeine at least about 0.3 μg/mL and maintains the concentration for at least four hours (see claim 1). Formulations are prepared using pharmaceutically acceptable carriers. As generally used herein “carrier” includes, but is not limited to, diluents, preservatives, binders, lubricants, disintegrators, swelling agents, fillers, stabilizers, and combinations thereof. Polymers used in the dosage form include hydrophobic or hydrophilic polymers and pH dependent or independent polymers. Preferred hydrophobic and hydrophilic polymers include, but are not limited to, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, carboxy methylcellulose, polyethylene glycol, ethylcellulose, microcrystalline cellulose, polyvinyl Carrier also includes all components of the coating composition which may include plasticizers, pigments, colorants, stabilizing agents, and glidants. Delayed release dosage formulations may be prepared as described in standard references. These references provide information on carriers, materials, equipment and process for preparing tablets and capsules and delayed release dosage forms of tablets, capsules, and granules. pyrrolidone, polyvinyl alcohol, polyvinyl acetate, and ion exchange resins (paragraph 0094). Carrier also includes all components of the coating composition which may include plasticizers, pigments, colorants, stabilizing agents, and glidants. Delayed release dosage formulations may be prepared as described in standard references. These references provide information on carriers, materials, equipment and process for preparing tablets and capsules and delayed release dosage forms of tablets, capsules, and granules (paragraph 0095). Examples of suitable coating materials include, but are not limited to, cellulose polymers such as cellulose acetate phthalate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl methylcellulose phthalate and hydroxypropyl methylcellulose acetate succinate; polyvinyl acetate phthalate, acrylic acid polymers and copolymers, and methacrylic resins that are commercially available under the trade name EUDRAGIT® (Roth Pharma, Westerstadt, Germany), zein, shellac, and polysaccharides (paragraph 0097). Optional pharmaceutically acceptable excipients include, but are not limited to, diluents, binders, lubricants, disintegrants, colorants, stabilizers, and surfactants. Diluents, also referred to as “fillers,” are typically necessary to increase the bulk of a solid dosage form so that a practical size is provided for compression of tablets or formation of beads and granules. Suitable diluents include, but are not limited to, dicalcium phosphate dihydrate, calcium sulfate, lactose, sucrose, mannitol, sorbitol, cellulose, microcrystalline cellulose, kaolin, sodium chloride, dry starch, hydrolyzed starches, pregelatinized starch, silicone dioxide, titanium oxide, magnesium aluminum silicate and powdered sugar (paragraph 0099). Binders are used to impart cohesive qualities to a solid dosage formulation, and thus ensure that a tablet or bead or granule remains intact after the formation of the dosage forms. Suitable binder materials include, but are not limited to, starch, pregelatinized starch, gelatin, sugars (including sucrose, glucose, dextrose, lactose and sorbitol), polyethylene glycol, waxes, natural and synthetic gums such as acacia, tragacanth, sodium alginate, cellulose, including hydroxypropylmethylcellulose, hydroxypropylcellulose, ethylcellulose, and veegum, and synthetic polymers such as acrylic acid and methacrylic acid copolymers, methacrylic acid copolymers, methyl methacrylate copolymers, aminoalkyl methacrylate copolymers, polyacrylic acid/polymethacrylic acid and polyvinylpyrrolidone (paragraph 0100). Extended release tablets containing hydrophilic polymers are prepared by techniques commonly known in the art such as direct compression, wet granulation, or dry granulation. Their formulations usually incorporate polymers, diluents, binders, and lubricants as well as the active pharmaceutical ingredient. Rather than selecting a particular surface for coating, the present formulations allows for coating the whole tablet at the same time providing different drug release profiles from different layers (paragraph 0111).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP 2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to modify the teachings of the teachings of ANDEUREASEU et al. by incorporating the effervescent material comprising an acid component and a base component, wherein the effervescent material has a particle size as measured by sieve analysis from about 30 to about 180 mm because Schobel teaches effervescent compositions in the form of tablets or powders comprising a therapeutic agent, a granulating agent, a microparticulate effervescent component and an effervescent system which dissolve rapidly in water to yield an effervescent solution containing a completely dissolved therapeutic agent and a process for their preparation (see abstract). Schobel teaches a rapid dissolving therapeutic effervescent composition which comprises: (1) a preblended mixture present in an amount from about 7 to about 57.5% by weight of (A) a granulated therapeutic agent having a particle size of about 100 to about 600 microns, wherein the granulated therapeutic agent comprises a therapeutic agent present in an amount from about 2% to about 27% by weight selected from the group consisting of acetaminophen, aspirin, ibuprofen and mixtures thereof, and a water soluble granulating agent present in an amount from about 0.03 to about 2.5% by weight, being compatible with the therapeutic agent and having a viscosity below 100 cps, 10% by weight, at 25° C. in water, and (B) a component of an effervescent system having a particle size of about 50 to about 600 microns, present in an amount from about 5% to about 30% by weight said component being selected from the group consisting of a carbonate, an acid and mixtures thereof, and (2) an effervescent system present in an amount from about 42.5% to about 90% by weight wherein the effervescent system comprises a carbonate containing material and an acid, all percentages are by weight of the total effervescent composition (see claim 1). One of ordinary skill in the art would have been motivated to do so because Schobel teaches that the effervescent system may comprise one or more components. The component of the effervescent system blended with the granulated therapeutic agent is in a microparticulate form having a particle size from about 50 to about 600 microns. In a preferred embodiment, the effervescent system comprises a carbonate containing material and an acid. The microparticulate component of the effervescent system may be the carbonate containing material, the acid and mixtures thereof (column 4, lines 48-56). Schobel teaches it is believed that the component of the effervescent system having a particle size of about 50 to about 600 microns because of its controlled particle size forms a uniform mixture with the granulated therapeutic agent which has about the same particle size. It is further believed that these particulate materials adhere to each other after mixing with the remaining components of the effervescent composition and that this property results in the formation of an extremely uniform effervescent composition which rapidly disintegrates in cold water dispersing the granulated therapeutic agent. It is believed that granulating prevents segregation of the therapeutic agent during mixing to form the effervescent composition and prevents agglomeration in solution after its release from the composition (column 2, lines 32-46). One of ordinary skill in the art would appreciate the teachings of Schobel in the preparation of a formulation wherein effervescent system is incorporated like in ANDEUREASEU et al. Furthermore, in the case where the amount of ingredients, particle sizes, etc., "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) Furthermore, differences in concentration or size will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). One of ordinary skill in the art would have had a reasonable chance or expectation of success in combining the teachings of ANDEUREASEU et al. and Schobel because both references teach formulations containing effervescent systems.
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to modify the teachings of the teachings of ANDEUREASEU et al. and Schobel et al. by incorporating a cellulose ether binder because Vepuri et al. teach an oral formulation comprising: a first component providing for immediate or rapid release of caffeine, and a second component providing for extended release of caffeine, wherein the formulation provides a blood plasma concentration of caffeine at least about 0.3 μg/mL and maintains the concentration for at least four hours (see claim 1). Formulations are prepared using pharmaceutically acceptable carriers. As generally used herein “carrier” includes, but is not limited to, diluents, preservatives, binders, lubricants, disintegrators, swelling agents, fillers, stabilizers, and combinations thereof. Polymers used in the dosage form include hydrophobic or hydrophilic polymers and pH dependent or independent polymers. Preferred hydrophobic and hydrophilic polymers include, but are not limited to, hydroxypropyl methylcellulose, hydroxypropyl cellulose, hydroxyethyl cellulose, carboxy methylcellulose, polyethylene glycol, ethylcellulose, microcrystalline cellulose, polyvinyl Carrier also includes all components of the coating composition which may include plasticizers, pigments, colorants, stabilizing agents, and glidants. Delayed release dosage formulations may be prepared as described in standard references. These references provide information on carriers, materials, equipment and process for preparing tablets and capsules and delayed release dosage forms of tablets, capsules, and granules. pyrrolidone, polyvinyl alcohol, polyvinyl acetate, and ion exchange resins (paragraph 0094). Carrier also includes all components of the coating composition which may include plasticizers, pigments, colorants, stabilizing agents, and glidants. Delayed release dosage formulations may be prepared as described in standard references. These references provide information on carriers, materials, equipment and process for preparing tablets and capsules and delayed release dosage forms of tablets, capsules, and granules (paragraph 0095). Examples of suitable coating materials include, but are not limited to, cellulose polymers such as cellulose acetate phthalate, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxypropyl methylcellulose phthalate and hydroxypropyl methylcellulose acetate succinate; polyvinyl acetate phthalate, acrylic acid polymers and copolymers, and methacrylic resins that are commercially available under the trade name EUDRAGIT® (Roth Pharma, Westerstadt, Germany), zein, shellac, and polysaccharides (paragraph 0097). Optional pharmaceutically acceptable excipients include, but are not limited to, diluents, binders, lubricants, disintegrants, colorants, stabilizers, and surfactants. Diluents, also referred to as “fillers,” are typically necessary to increase the bulk of a solid dosage form so that a practical size is provided for compression of tablets or formation of beads and granules. Suitable diluents include, but are not limited to, dicalcium phosphate dihydrate, calcium sulfate, lactose, sucrose, mannitol, sorbitol, cellulose, microcrystalline cellulose, kaolin, sodium chloride, dry starch, hydrolyzed starches, pregelatinized starch, silicone dioxide, titanium oxide, magnesium aluminum silicate and powdered sugar (paragraph 0099). One of ordinary skill in the art would have been motivated to include cellulose ether binders in the slow release coating layer because Vepuri et al. teach that binders are used to impart cohesive qualities to a solid dosage formulation, and thus ensure that a tablet or bead or granule remains intact after the formation of the dosage forms. Suitable binder materials include, but are not limited to, starch, pregelatinized starch, gelatin, sugars (including sucrose, glucose, dextrose, lactose and sorbitol), polyethylene glycol, waxes, natural and synthetic gums such as acacia, tragacanth, sodium alginate, cellulose, including hydroxypropylmethylcellulose, hydroxypropylcellulose, ethylcellulose, and veegum, and synthetic polymers such as acrylic acid and methacrylic acid copolymers, methacrylic acid copolymers, methyl methacrylate copolymers, aminoalkyl methacrylate copolymers, polyacrylic acid/polymethacrylic acid and polyvinylpyrrolidone (paragraph 0100). Extended release tablets containing hydrophilic polymers are prepared by techniques commonly known in the art such as direct compression, wet granulation, or dry granulation. Their formulations usually incorporate polymers, diluents, binders, and lubricants as well as the active pharmaceutical ingredient. Rather than selecting a particular surface for coating, the present formulations allows for coating the whole tablet at the same time providing different drug release profiles from different layers (paragraph 0111). Additionally, substituting one adhesive or binder with another in the pharmaceutical formulation art is obvious because the binders are functionally equivalent. One of ordinary skill in the art would have had a reasonable chance or expectation of success in combining the teachings of ANDEUREASEU et al. Schobel, and Vepuri et l. because ANDEUREASEU et al. and Schobel teach effervescent compositions for the delivery of actives while Vepuri et al. teach the delivery of caffeine in both rapid and slow release fashions.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been prima facie obvious before the effective filing date of the instant application within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over ANDEUREASEU et al. (EP 2233134, previously cited) in view of Schobel (US Patent No. 4,687,662, previously cited) and Vepuri et al. (US 2016/0128943, newly cited), as applied to claims 1 and 6-4 above, and further in view of Mouradian et al. (WO2020/092930, newly cited).
Applicants’ claims
Applicant claims “A multi-layered tablet configured for oral use, the tablet comprisinga first layer comprising an effervescent composition and a second layer comprising a non-effervescent composition, wherein: the effervescent composition comprises an effervescent material capable of causing effervescence in the oral cavity, the effervescent material comprising an acid component and a base component, wherein the effervescent material has a particle size as measured by sieve analysis from about 30 to about 180 µm; one or more fillers in a total amount of at least about 30% by weight, based on the total weight of the effervescent composition, wherein the one or more fillers include at least one sugar alcohol; and a first active ingredient comprising caffeine; and the non-effervescent composition comprises one or more fillers in a total amount of at least about 30% by weight, based on the total weight of the non-effervescent composition, wherein the one or more fillers include at least one sugar alcohol; a cellulose ether binder; and a second active ingredient comprising caffeine, wherein the multi-layered tablet is completely free of tobacco material or comprises less than 0.1% by weight of tobacco material and is completely free of nicotine.” Claims 3 recites “The multi-layered tablet of claim 1, wherein the first active ingredient, the second active ingredient, or both the first and second active ingredient further comprises taurine and vitamin C. Claim 4 recites “The multi-layered tablet of claim 1, wherein the first active ingredient, the second active ingredient, or both the first and second active ingredient further comprises L-theanine, sunflower lecithin, and Panax ginseng.”
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
The teachings of ANDEUREASEU et al., Schobel, and Vepuri et al. are described above in detail and are incorporated by reference herein.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
ANDEUREASEU et al., Schobel, and Vepuri et al. do not specifically teach wherein the first active ingredient, the second active ingredient, or both the first and second active ingredient further comprises taurine and vitamin C and wherein the first active ingredient, the second active ingredient, or both the first and second active ingredient further comprises L-theanine, sunflower lecithin, and Panax ginseng. This deficiency is cured by the teachings of Mouradian et al.
Mouradian et al. teach a neuroprotective compositions containing caffeine or a caffeine analogue and a long chain fatty acyl tryptamide with an aliphatic chain having 16 to 22 carbons linked to a tryptamine, wherein the composition contains from at least 1.5 mg to 600 mg of caffeine per serving or unit dosage of the composition; from at least 0.5 mg to 300 mg of the long chain fatty acyl tryptamide per serving or unit dosage of the composition; and the ratio of long chain fatty acyl tryptamide to caffeine is from 1:1200 to 200:1. Methods are also disclosed for treating or preventing cognitive and movement deficits of a disease, condition or disorder or neurological deterioration that use the disclosed neuroprotective compositions (see abstract). According to another embodiment, the active ingredients of the composition are the long chain fatty acyl tryptamide and caffeine. However, the composition of the invention may contain other things. According to one embodiment of the invention, the composition contains caffeine, the long chain fatty acyl tryptamide, and either a pharmaceutically acceptable carrier, excipient, electrolyte, legal stimulant, vitamin, mineral, or health supplement, or a combination thereof (paragraph 0050). . According to another embodiment, the neuroprotective composition of the invention is administered in a form selected from the group consisting of a beverage, foodstuff, chewing gum, candy, chocolate bar, pharmaceutical composition, nutraceutical or nutritional supplement. According to another embodiment, the beverage used in the method is selected from the group consisting of water, a fruit drink, coffee, tea, energy drink, nutritional drink or sport drink. According to another embodiment, the pharmaceutical composition is administered in the form of a powder, tablet, capsule, dissolving strips, lozenge, syrup, suspension, emulsion, tincture, elixir or effervescent formulation (paragraph 0014). According to yet another embodiment, the pharmaceutical composition may be administered in the form of a powder, tablet, capsule, lozenge, strips, syrup, suspension, emulsion, tincture, elixir or effervescent formulation, and the like (paragraph 0059). According to yet another embodiment of the invention, the pharmaceutically acceptable legal stimulants include, for example, guarana, taurine, ginseng, vitamin B complex (including, for example, thiamine ( vitamin Bi ), riboflavin ( vitamin B2), etc., and the like, or combinations thereof (paragraph 0054). According to a further embodiment of the invention, the pharmaceutically acceptable vitamins include, for example, vitamin C, vitamin D, vitamin E, vitamin K, etc., and the like (paragraph 0055). According to another embodiment of the invention, the pharmaceutically acceptable food and health supplements include, for example, N-acetyl L-cysteine, L-theanine, etc., herb parts (e.g., leaves, roots, buds, flowers, stem or the like) or herb, fruit or botanical extracts (e.g., green tea extract, bilberry fruit standardized extract, grape skin extract, guarana extract, kola nut extract, peppermint oil, tulsi extract (holy basil), green tea extract, gingko biloba extract, rhodiola extract, white tea extract, black tea extract, panax ginseng , and the like, or combinations thereof (paragraph 0057). According to a different embodiment of the invention, the pharmaceutically acceptable excipient may be microcrystalline cellulose, glycerin, sunflower lecithin, sorbitol, modified food starch, etc., or combinations thereof (paragraph 0052). A method of treating or prophylactic ally treating a patient at risk of developing cognitive and movement deficits of a disease, condition or disorder selected from the group consisting of Alzheimer’s disease, Mild Cognitive Impairment, Parkinson’s disease, Parkinson’s disease dementia, Lewy Body Dementia, Progressive Supranuclear Palsy, Multisystem Atrophy, Corticobasal Degeneration, Frontotemporal Dementia, Huntington’s disease, Amyotrophic Lateral Sclerosis, Spinocerebellar Ataxia, Friedrich's Ataxia, bipolar disorder, cerebrovascular disorder, traumatic brain injury, encephalopathy, traumatic brain injury, Chronic Traumatic Encephalopathy, multiple sclerosis, other demyelinating and inflammatory disorders of the nervous system, comprising administering the composition of claim 1 at a dosage of at least 0.5 mg of the long chain fatty acyl tryptamide, and at least 1.5 mg of the caffeine (claim 13). The method according to claim 13, wherein the neuroprotective composition is administered in a form selected from the group consisting of a beverage, foodstuff, chewing gum, candy, chocolate bar, pharmaceutical composition, nutraceutical or nutritional supplement (claim 16). The method according to claim 16 wherein the pharmaceutical composition is administered in the form of a powder, tablet, capsule, dissolving strips, lozenge, syrup, suspension, emulsion, tincture, elixir or effervescent formulation (claim 18).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP 2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant invention to modify the teachings of the teachings of ANDEUREASEU et al., Schobel, and Vepuri et al. by incorporating taurine, vitamin C, L-theanine, sunflower lecithin, and Panax ginseng because Mouradian et al. teach a neuroprotective compositions containing caffeine or a caffeine analogue and a long chain fatty acyl tryptamide with an aliphatic chain having 16 to 22 carbons linked to a tryptamine, wherein the composition contains from at least 1.5 mg to 600 mg of caffeine per serving or unit dosage of the composition; from at least 0.5 mg to 300 mg of the long chain fatty acyl tryptamide per serving or unit dosage of the composition; and the ratio of long chain fatty acyl tryptamide to caffeine is from 1:1200 to 200:1. Methods are also disclosed for treating or preventing cognitive and movement deficits of a disease, condition or disorder or neurological deterioration that use the disclosed neuroprotective compositions (see abstract). According to another embodiment, the active ingredients of the composition are the long chain fatty acyl tryptamide and caffeine. However, the composition of the invention may contain other things. According to one embodiment of the invention, the composition contains caffeine, the long chain fatty acyl tryptamide, and either a pharmaceutically acceptable carrier, excipient, electrolyte, legal stimulant, vitamin, mineral, or health supplement, or a combination thereof (paragraph 0050). . According to another embodiment, the neuroprotective composition of the invention is administered in a form selected from the group consisting of a beverage, foodstuff, chewing gum, candy, chocolate bar, pharmaceutical composition, nutraceutical or nutritional supplement. According to another embodiment, the beverage used in the method is selected from the group consisting of water, a fruit drink, coffee, tea, energy drink, nutritional drink or sport drink. According to another embodiment, the pharmaceutical composition is administered in the form of a powder, tablet, capsule, dissolving strips, lozenge, syrup, suspension, emulsion, tincture, elixir or effervescent formulation (paragraph 0014). According to yet another embodiment, the pharmaceutical composition may be administered in the form of a powder, tablet, capsule, lozenge, strips, syrup, suspension, emulsion, tincture, elixir or effervescent formulation, and the like (paragraph 0059). According to yet another embodiment of the invention, the pharmaceutically acceptable legal stimulants include, for example, guarana, taurine, ginseng, vitamin B complex (including, for example, thiamine ( vitamin Bi ), riboflavin ( vitamin B2), etc., and the like, or combinations thereof (paragraph 0054). According to a further embodiment of the invention, the pharmaceutically acceptable vitamins include, for example, vitamin C, vitamin D, vitamin E, vitamin K, etc., and the like (paragraph 0055). According to another embodiment of the invention, the pharmaceutically acceptable food and health supplements include, for example, N-acetyl L-cysteine, L-theanine, etc., herb parts (e.g., leaves, roots, buds, flowers, stem or the like) or herb, fruit or botanical extracts (e.g., green tea extract, bilberry fruit standardized extract, grape skin extract, guarana extract, kola nut extract, peppermint oil, tulsi extract (holy basil), green tea extract, gingko biloba extract, rhodiola extract, white tea extract, black tea extract, panax ginseng , and the like, or combinations thereof (paragraph 0057). According to a different embodiment of the invention, the pharmaceutically acceptable excipient may be microcrystalline cellulose, glycerin, sunflower lecithin, sorbitol, modified food starch, etc., or combinations thereof (paragraph 0052). A method of treating or prophylactic ally treating a patient at risk of developing cognitive and movement deficits of a disease, condition or disorder selected from the group consisting of Alzheimer’s disease, Mild Cognitive Impairment, Parkinson’s disease, Parkinson’s disease dementia, Lewy Body Dementia, Progressive Supranuclear Palsy, Multisystem Atrophy, Corticobasal Degeneration, Frontotemporal Dementia, Huntington’s disease, Amyotrophic Lateral Sclerosis, Spinocerebellar Ataxia, Friedrich's Ataxia, bipolar disorder, cerebrovascular disorder, traumatic brain injury, encephalopathy, traumatic brain injury, Chronic Traumatic Encephalopathy, multiple sclerosis, other demyelinating and inflammatory disorders of the nervous system, comprising administering the composition of claim 1 at a dosage of at least 0.5 mg of the long chain fatty acyl tryptamide, and at least 1.5 mg of the caffeine (claim 13). The method according to claim 13, wherein the neuroprotective composition is administered in a form selected from the group consisting of a beverage, foodstuff, chewing gum, candy, chocolate bar, pharmaceutical composition, nutraceutical or nutritional supplement (claim 16). The method according to claim 16 wherein the pharmaceutical composition is administered in the form of a powder, tablet, capsule, dissolving strips, lozenge, syrup, suspension, emulsion, tincture, elixir or effervescent formulation (claim 18). One of ordinary skill in the art would have been motivated to do so because taurine, vitamin C, L-theanine, and Panax ginseng are known to provide various health benefits and sunflower lecithin can serve as a carrier or an excipient as demonstrated by Mouradian et al. Furthermore, it should be noticed that ANDEUREASEU et al. teach that other additives may be added optionally to the oral formulation. Optional additives comprise at least one or more additives selected from the group consisting of solvents, such as ethanol and water; co-solvents, such as propylene glycol; stabilisers, such as preservatives, e g antioxidants; softeners, such as sorbitol and glycerine; thickening/flowability agents, such as colloidal silicon dioxide; binding agents, such as xanthan gum; filling agents, such as mannitol, isomalt, cocoa powder and Crospovidone; solubilizers, such as Polysorbat 80 and Atmos 300; rubbers, lipid barriers, such as sucrose fatty acid esters and hydrogenated vegetable oils; film forming agents, such as gelatine, Pullulan, carrageenan, pectin, locust bean gum and xanthan gum; emulsifiers, such as pectin, soy lecithin, glycerol monostearate, castor oil and poloxamer; glidants, such as colloidal silicon dioxide; lubricants, such as magnesium stearate; coating agents, such as castor oil and sorbitol; melting vehicles, such as vegetable oils; sweeteners, flavors, aromatics, cooling agents, enhancers, colouring agents, vitamins, minerals, fluorine, breath fresheners, tooth whitening agents and mixtures thereof. According to the invention, at least one of such additives is optionally added to the product (paragraph 0077). The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.). "A person of ordinary skill in the art is also a person of ordinary creativity, not an automaton."KSR, 550 U.S. at 421, 82 USPQ2d at 1397. "[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle."Id. at 420, 82 USPQ2d at 1397. Office personnel may also take into account "the inferences and creative steps that a person of ordinary skill in the art would employ."Id. at 418, 82 USPQ2d at 1396. One of ordinary skill in the art would have had a reasonable chance or expectation of success in combining the teachings of ANDEUREASEU et al., Schobel, Vepuri et al., and Mouradian et al. because all of the references teach formulations containing similar and overlapping ingredients.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been prima facie obvious before the effective filing date of the instant application within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 04 August 2026 have been fully considered but they are not persuasive. The rebuttal arguments are provided to the extent they are applicable to the current rejection.
Applicant argues Hugerth (ANDEUREASEU et al.) does not teach or suggest a multi-layer tablet in which the first and second active ingredients comprise caffeine as recited in claim 1. Further, Hugerth does not teach or suggest a multi-layer tablet which is completely free of nicotine as recited in claim 1. The Office correctly recognizes that Hugerth teaches caffeine, but then asserts that "if caffeine is utilized as one of the alternative active agents the formulation is free of nicotine" and that "a prior art reference must be considered in its entirety" (Office Action, p. 8 and 13-14, respectively). Applicant does not dispute this general principle but respectfully submits that the Office has misapplied it. Hugerth is directed, in its entirety, to multi-portion intra-oral dosage forms for delivering nicotine to treat tobacco dependence. The reference's entire disclosure, including every single working example (Examples 1-19) are directed to nicotine-containing formulations. Caffeine appears exactly once in the entire reference, buried within an exhaustive laundry list of dozens of pharmaceutically active agents spanning multiple therapeutic categories at paragraph [0058], classified under "psychostimulant." Hugerth provides no guidance, preference, direction, or working example suggesting the selection of caffeine from this extensive list. The law is clear that a prior art reference's mere inclusion of an element within a comprehensive list does not, standing alone, constitute a teaching or suggestion to select that element, particularly when the reference provides no preference for or working example of the listed element. See Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804 (Fed. Cir. 1989); In re Jones, 958 F.2d 347 (Fed. Cir. 1992). In the present case, a person of ordinary skill would have no reason to single out caffeine from Hugerth's extensive list and simultaneously remove nicotine - the very substance around which Hugerth's entire invention is constructed. To the contrary, Hugerth discloses an effervescent tablet containing nicotine for use in treating tobacco dependence. Accordingly, one of skill in the art would not be motivated to remove nicotine in the product of Hugerth and replace it with caffeine.
The above assertions are not found persuasive because the examiner maintains that ANDEUREASEU et al. indeed teach caffeine. ANDEUREASEU et al. teach that the present invention may thus be employed in embodiments where for example, but not limited to, one or more pharmaceutically active and/or health promoting agent(s) is/are chosen from psychostimulant, for example caffeine; etc., (see paragraph 0058). A prior art reference must be considered in its entirety, i.e., as a whole, including portions that would lead away from the claimed invention. W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 220 USPQ 303 (Fed. Cir. 1983), cert. denied, 469 U.S. 851 (1984) (Claims were directed to a process of producing a porous article by expanding shaped, unsintered, highly crystalline poly(tetrafluoroethylene) (PTFE) by stretching said PTFE at a 10% per second rate to more than five times the original length. The prior art teachings with regard to unsintered PTFE indicated the material does not respond to conventional plastics processing, and the material should be stretched slowly. A reference teaching rapid stretching of conventional plastic polypropylene with reduced crystallinity combined with a reference teaching stretching unsintered PTFE would not suggest rapid stretching of highly crystalline PTFE, in light of the disclosures in the art that teach away from the invention, i.e., that the conventional polypropylene should have reduced crystallinity before stretching, and that PTFE should be stretched slowly). Allied Erecting v. Genesis Attachments, 825 F.3d 1373, 1381, 119 USPQ2d 1132, 1138 (Fed. Cir. 2016) ("Although modification of the movable blades may impede the quick change functionality disclosed by Caterpillar, ‘[a] given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine.’" (quoting Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165, 77 USPQ2d 1865, 1870 (Fed Cir. 2006) (citation omitted))). For, ANDEUREASEU et al. to be a proper prior art ANDEUREASEU et al. don’t need to exemplify the incorporation of caffeine. The examiner reminds Applicant that "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed."). Furthermore, it should be noticed that nonpreferred and alternative embodiments constitute prior art. Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have "relatively acceptable dimensional stability" and "some degree of flexibility," but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant’s argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since "Gurley asserted no discovery beyond what was known in the art." Id. at 554, 31 USPQ2d at 1132.). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Applicant argues without acquiescing to any alleged obviousness, but solely to expedite prosecution, Applicant has amended claim 1 to recite that the binder is a cellulose ether binder. This feature is not taught or suggested in Hugerth. To the contrary, Hugerth's teachings affirmatively lead a person of ordinary skill away from the claimed use of a cellulose ether as a binder in a non-effervescent layer. Hugerth mentions hydroxypropyl cellulose (HPC) at only one point in the reference: paragraph [0087], under the heading "Water-Swellable Excipients." HPC is listed alongside superdisintegrants - crospovidone, croscarmellose, sodium starch glycolate, and microcrystalline cellulose - and is classified as a material "designed to swell or wick liquid upon contact with a liquid medium and to aid in the dissolution of the compressed tablet" (paragraph [0085], emphasis added). Hugerth teaches that HPC, when used, belongs in the rapidly dissolving portion of the tablet and functions to promote and accelerate dissolution. The water-swellable excipient (including HPC) is present in small amounts - from about 0.1 to about 5 percent by weight - at ratios to compressible excipient of about 5:1 to about 500:1. By contrast, claim 1 as amended recites a cellulose ether serves as a binder in the non-effervescent composition - a layer engineered for slow, sustained release. The specification explains that the binder enhances the cohesive properties of the non-effervescent composition, "thereby attenuating the release of the active ingredient and/or flavorant from the non-effervescent layer upon use of the tablet." This is the functional opposite of Hugerth's teaching. Hugerth classifies HPC as a dissolution-promoting material in a fast dissolving layer; the claimed invention employs a cellulose ether as a cohesion-enhancing binder in a slow dissolving layer. A person of ordinary skill following Hugerth's teachings would not only lack motivation to relocate HPC to a non-effervescent, slowly dissolving layer - they would be led away from doing so because Hugerth's entire framework associates HPC with the rapid dissolution function. Applicant further argues Schobel and Mouradian et al. do not remedy the deficiencies of ANDEUREASEU et al. for not teaching cellulose ether binder.
The above assertions are not found persuasive because first the examiner would remind Applicant that Applicant’s claim 1 does not require that the first layer being rapid release and the second layer being slow release. The claim requires the first layer comprising an effervescent composition and the second layer comprising a non-effervescent composition. ANDEUREASEU et al. teach that in one embodiment, each portion of the multi portion intra-oral dosage form according to the invention comprises at least one item selected from a pharmaceutically active agent, a pH-buffering component, a pH-regulating component, a flavor, a barrier component, a color component, an adhesive component (which the examiner equates as binders), a taste masking agent, a health promoting agent e g a tooth whitening agent, a breath freshening agent, an oral health promoting agent, and an anti-caries agent, preferably the pharmaceutically active or health promoting agent is selected from an agent for treating tobacco dependence, such as nicotine, and a nicotine mimicking agent (see paragraph 0099). Therefore, the inclusion of a binder or an adhesive component in both layers is covered. The inclusion of cellulose ether binders is addressed by the newly introduced reference Vepuri et al. as described above in detail.
Conclusion
No claims are allowed.
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/TIGABU KASSA/
Primary Examiner, Art Unit 1619
Prosecution Insights