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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The instant application, filed on 08/25/2023 claims domestic benefit to prior-filed application, Application No. 63/401,795, filed on 08/29/2022.
Status of Claims/Application
After the preliminary amendment on 01/08/2024, claims 1 – 11, 13, 15, 18 – 20, 31, 36, 49, and 50 are currently pending and are examined on the merits herein.
Information Disclosure Statement
Information disclosure statement (IDS) submitted by the applicant on 03/26/2024 is in compliance with the provisions of 37 CFR 1.97. It has been considered by the examiner.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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. 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.
Claims 1, 2, 5 - 11, 13, 15, 20, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0169008 (IDS 03/26/2024).
US’008 teaches the product and process of manufacturing an edible soft-chewable form for the delivery of pharmaceutically active ingredients, or nutritional agents orally to an animal (Abstract). US’008 teaches that the pharmaceutically active ingredients include antibiotics, analgesics, antiviral, antifungal, anti-parasitic, hormones, anti-inflammatory (including nonsteroidal anti-inflammatory), steroids, behavior modifiers, vaccines, antacids, laxatives, anticonvulsants, sedatives, tranquilizers, antitussives, antihistamines, decongestants, expectorants, appetite stimulants and suppressants, cardiovascular drugs, minerals and vitamins along with other supplement and nutraceutical agents ([0022], pg. 2, col. 2).
US’008 provides a process for the manufacture of an edible compressed soft-chew tablet or semi plastic oral unit dosage form employing the steps of (a) mixing at least one active ingredient with at least one dry or liquid component to form a liquid premix; (b) blending dry ingredients having at least one of each of a bulking agent, a lipid, a flavoring agent, a disintegrating agent, a binding agent, a surfactant, a preservative, a lubricating agent, and an anti-sticking to form a uniform dry ingredient mixture; (c) blending the premix and the uniform dry ingredient mixture to form a granulated compacted soft-chew mass; (d) sifting the granulated compacted soft-chew mass through at least one sifting screen to form uniform granules of the soft-chew mass; and (d) adding a lubricant or anti sticking agent to the uniform granules of the soft-chew mass and compressing the resulting mixture in a tablet press to from soft-chew tablets ([0035], pg. 3. col. 1).
US’008 teaches that the composition of the soft-chewable dosage form includes a lipid that may be a liquid vegetable oil, or a solid hydrogenated vegetable oil. The vegetable oil may be, for example, soybean oil, olive oil, flaxseed oil, canola oil, or corn oil ([0049], pg. 3, col. 2). US’008 teaches one or more diluents may be used in combination with silicified microcrystalline cellulose. Examples of diluents include starches and their derivatives (e.g. hydrogenated starch hydrosylate), celluloses and their derivatives (e.g. cellulose acetate), protein matrices (soy protein, dextrates, wheat gluten, whey, corn cob, corn gluten), carbohydrates (e.g. maltodextrin, polydextrose), sugars and sugar alcohols (glucose, lactose, fructose, maltose, dextrose, sucrose, maltitol, xylitol, isomalt, mannitol), silicates, calcium phosphates, calcium sulfate, dextrates, kaolin, magnesium carbonate, polymethacrylates, talc, salts (e.g. sodium chloride) or any combination of any two or more thereof ([0055], pg. 4, col. 1). In an embodiment of US’008, the composition includes a starch, or a modified starch, or a mixture of starch and a modified starch ([0056], pg. 4, col. 1).
US’008 teaches that the chewable formulation includes one or more binders ([0058], pg. 4, col. 1). US’008 teaches that the formulation may include one or more palatability enhancers. Palatability enhancers improve the taste of material that is chewed. Advantageously, palatability enhancers may improve the palatability of soft-chewable formulations comprising bitter, acrid, obnoxious, unpleasant, or otherwise unpalatable nutritional or pharmaceutically active agents ([0059], pg. 4, col. 1). US’008 teaches that flavoring agents may be used to improve the palatability of the chewable tablets and flavors can be natural (derived from animal or plant sources), semisynthetic, or artificial ([0061], pg. 4, col. 2). US’008 teaches that the composition may include a non-active ingredient including of one or more of a starch, a polysaccharide, a humectant, a polyol, water-soluble poly(ethylene oxide) resin ([0064], pg. 4, col. 2).
US’008 teaches that the composition may include a humectant. A humectant is used to retain moisture in the dosage unit. A humectant of value may be selected from sodium and potassium chloride, benzalkonium chloride, aluminum silicate, sodium propionates, sodium and potassium phosphates, sugars, sulfites, hydrogenated starch hydrosylate, etc. Liquid humectants include, but are not limited to, glycols, polyols, sugar alcohols, vegetable oils and mineral oil, hydrogenated vegetable oils, hydrocarbons, triacetin, liquid paraffin, or any combination of any two or more thereof. Other humectants known in the art may also be used ([0065], pg. 4, col. 2).
US’008 teaches that the composition may include a preservative selected from the group including parabens (methylparaben and/or propylparaben), benzalkonium chloride, benzethonium chloride, benzoic acid, citric acid, fumaric acid, benzyl alcohol, bronopol, butylparaben, cetrimide, chlorhexidine, chlorobutanol, chlorocresol, cresol, ethylparaben, imidurea, methylparaben, phenol, phenoxyethanol, phenylethyl alcohol, potassium sorbate, sodium benzoate, sodium propionate, sorbic acid, thimerosal and quaternary ammonium compounds. Other preservatives known in the art may also be used ([0067], pg. 5, col. 1).
US’008 teaches that the chewable formulation may include a non-aqueous solvent, for example glycerin. A non-aqueous solvent may disperse, solubilize or enhance solubilization of the nutritional or pharmaceutically active agent. The non-aqueous solvent may also enhance the binding of the formulation and the consistency and texture of the soft-chewable dosage form ([0068], pg. 5, col. 1). US’008 teaches that the chewable formulation may include a disintegrating agent. A disintegrating agent may be selected from povidones, croscarmellose sodium, sodium starch glycollate, celluloses and their derivatives, starches and their derivatives, gelatin, silicon dioxide, or any combination of any two or more thereof ([0069], pg. 5, col. 1).
US’008 exemplifies a soft chewable form in Table 4 - Example 4, ingredients in granulation aid and intragranular addition are given below to explain how some of the claim limitations of the instantly claimed invention are met ([0113], pg. 7, col. 2). Carprofen as active ingredient 3.34%, thus meets the instantly claimed invention’s claim 1 limitation of at least one active ingredient between about 0.001% w/w and about 40% w/w. Soybean oil and Zea Mays oil as lipid 9.1%, thus meets the instantly claimed invention’s claim 1 limitation of a lipid between about 5% w/w and about 15% w/w. Glycerin as humectant 13%, thus meets the instantly claimed invention’s claim 7 limitation of the humectant comprises between about 8% w/w and about 20% w/w. Povidone K 30 2% as binder. Croscarmellose Sodium 2.5% as disintegrant, thus meets the instantly claimed invention’s claim 1 limitation of a disintegrant between about 0.1% w/w and about 10.0% w/w. Silicified microcrystalline cellulose as polymeric carbohydrate 18.66%, thus meets the instantly claimed invention’s claim 1 limitation of one or more carbohydrates between about 5% w/w and about 25% w/w. Pregelatinized Corn Starch 7%, thus meets the instantly claimed invention’s claim 1 limitation of a starch between about 2% w/w and about 50% w/w. Artificial beef flavor 15%, thus meets the instantly claimed invention’s claim 1 limitation of a flavoring agent between about 5% w/w and about 15% w/w. Extragranular addition has more of starch, carbohydrate, flavorant, disintegrant, including sodium lauryl sulfate as surfactant, thus meeting the claim limitations of the instantly claimed invention’s claim 31. Example 3 of US’008 includes many of the same ingredients along with modified starch as extragranular addition.
Regarding claim 1, US’008 does not teach that the starch comprises a regular starch and a pre-gelatinized starch that is in a ratio from about 3:1 to about 15:1. However, as it teaches the composition includes a starch, or a modified starch, or a mixture of starch and a modified starch ([0056], pg. 4, col. 1), it would have been obvious to select a starch, a modified starch, a pregelatinized starch or a mixture thereof before the effective filing date of the claimed invention to arrive at the soft chewable formulation of the instantly claimed invention. Once that is achieved, it would have been obvious for one of ordinary skill in the art to optimize the ratio of the regular starch and the pregelatinized starch before the effective filing date of the claimed invention to arrive at the desired nutritional characteristics and consistency of the soft chewable formulation that is proposed by the claimed invention. It would have been prima facie obvious for one of ordinary skill in the art to modify the teachings of US’008 to utilize both regular and pregelatinized starches, and to optimize the ratio of the starches in order to arrive at a soft chewable formulation of desired, consistent, nutritional characteristics.
Regarding claim 2, US’008 teaches that the flavoring agents can be natural (derived from animal or plant sources) ([0061], pg. 4, col. 2).
Regarding claims 5 - 7, the inclusion of a humectant and that the humectant comprises between about 8% w/w and about 20% w/w of the soft chewable veterinary formulation, the claim limitations are met as US’008 teaches the addition of Glycerin as humectant 13% in the Example 4 discussed above.
Regarding claim 8 - 10, as US’008 teaches the inclusion of a preservative, a preservative selected from the group including parabens (methylparaben and/or propylparaben), benzalkonium chloride, benzethonium chloride, benzoic acid, citric acid, fumaric acid, benzyl alcohol, bronopol, butylparaben, cetrimide, chlorhexidine, chlorobutanol, chlorocresol, cresol, ethylparaben, imidurea, methylparaben, phenol, phenoxyethanol, phenylethyl alcohol, potassium sorbate, sodium benzoate, sodium propionate, sorbic acid, thimerosal and quaternary ammonium compounds ([0067], pg. 5, col. 1), which meets the claim limitations of claims 8 and 9 of the instantly claimed invention , it would have been obvious to include a preservative in the ingredients of the Example 4 discussed above to ensure the shelf stability of the formulation before the effective filing date of the claimed invention to arrive at the soft chewable formulation of the instantly claimed invention. Further, it would have been obvious for one of ordinary skill in the art to optimize the effective amount of the preservative needed in the composition before the effective filing date of the claimed invention to ensure the shelf stability of the soft chewable formulation with active ingredients.
Regarding claim 11, US’008 teaches the inclusion of a binder ([0058], pg. 4, col. 1) and includes Povidone K 30 in the Example 4 as discussed above.
Regarding claim 13, US’008 teaches the inclusion of Croscarmellose Sodium as a disintegrant in the Example 4 discussed above.
Regarding claim 15, of the emulsifying agents disclosed by the specification of the instantly claimed invention ([0005], pg. 1, col. 2), US’008 teaches the inclusion of Polyethylene Glycol 600 in the Example 4 discussed above.
Regarding claim 20, US’008 teaches the active ingredient carprofen in the Example 4 discussed above.
Regarding claim 31, the chewable veterinary formulation further comprises one or more components selected from the group consisting of surfactants, wetting agents, pH stabilizers, a softening agent, and a solvent, the claim limitations are met as US’008 teaches the inclusion of sodium lauryl sulfate as surfactant in the Example 4 discussed above.
Claims 3, 4, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0169008 A1 (IDS 03/26/2024) as applied to claims 1, 2, 5 - 11, 13, 15, 20, and 31 above, and further in view of US 2020/0360290 A1 (IDS 03/26/2024).
The teachings of US’008 were as discussed above. The independent claim, claim 1 of the instantly claimed invention was rejected as indicated above.
The teachings of US’008 differ from that of the instantly claimed invention in that they do not teach that the animal- derived flavoring agent is chicken liver powder, pork liver powder, beef liver powder, ham, fish, or a combination thereof, wherein the chicken- liver comprises about 8% to about 14% of the soft chewable veterinary formulation, and at least one active ingredient is at least one active anti-parasitic active ingredient.
US’290 teaches the preparation of compositions for therapeutic purposes, which are formulated in solid form to be administered to animals, more particularly to improve oral administration and to guarantee treatment compliance ([0001], pg. 1, col. 1). US’290 relates to a process for preparing a solid composition comprising at least one active ingredient, and at least one excipient ([0014], pg. 2, col. 1). US’290 teaches a solid composition comprises at least one active ingredient chosen from among anti-infectives such as antibiotics and sulfonamides, cardiotonics, internal and external anti-parasitics, insecticides, insect growth inhibitors, anti-arthritics, anti-inflammatories whether or not steroidal, anti-histaminics, hormones such as prostaglandins, substances for digestive therapy such as gastro-intestinal dressings and sedatives, anti-ulcer agents and substitution flora, anti-diarrhoeals, hepato-protectors, antispasmodics, laxatives, intestinal antiseptics, substances for respiratory therapy such as respiratory analeptics, antitussives, bronchodilators, bronchial and mucolytic fluidifiers and respiratory antiseptics, substances acting on the nervous system such as analgesics, sedatives and tranquillizers, anti-epileptics, anaesthetics, orexigenics, anorexigenics, substances for immunity therapy such as interleukins and interferon, substances for anticancer therapy such as antimitotics and cytostatics, macro-, micro-nutrients and trace elements, vitamins, plant extracts, extracts from animal organs, and a mixture thereof ([0019], pg. 2, col. 1). US’290 teaches a solid composition comprises at least one excipient chosen from among a palatable material, a humectant, a binder, a lubricant, a filler, a disintegrant, and a mixture thereof ([0021], pg. 2, col. 1).
US’290 teaches a solid composition comprises: between 0.01 and 20.00%, preferably between 1.00 and 10% by weight of said at least one active ingredient ([0023], pg. 2, col. 1), between 15.00 and 30.00%, preferably about 20.00% by weight of said at least one palatable material ([0024], pg. 2, col. 1), between 15.00 and 35.00%, preferably between 20.00 and 30.00% by weight of said at least one humectant ([0025], pg. 2, col. 2), between 20.00 and 40.00%, preferably about 24.50% by weight of said at least one binder ([0026], pg. 2, col. 2), between 0.10 and 10.00%, preferably about 5.00% by weight of said at least one lubricant ([0027], pg. 2, col. 2), between 10.00 and 30.00%, preferably between 15.00 and 25.00% by weight of said at least one filler ([0028], pg. 2, col. 2), and between 0.10 and 10.00%, preferably about 4.00% by weight of said at least one disintegrant, relative to the total weight of the solid composition ([0029], pg. 2, col.2). US’290 teaches a solid composition further comprises at least one preservative and/or at least one antioxidant, and/or at least one chelating agent ([0030], pg. 2, col. 2).
US’290 teaches that at least one active ingredient is a substance having a repulsive odor and/or or taste. These are for example aldosterone antagonists, angiotensin conversion enzyme inhibitors, antagonists of the AT-1 receptor of angiotensin II, inotropic agents, inodilators, vasodilators, diuretics, digitalis drugs, beta blockers and/or calcium antagonists. The process is also advantageous when said pharmaceutical active substances are unstable and sensitive to moisture ([0055],pg. 3, col. 2). US’290 teaches the active ingredients, among the inodilators, pimobendane or levosimendane may be mentioned ([0058], pg. 3, col. 2). US’290 teaches the solid veterinary composition comprises milbemycin, milbemycin oxyme, both milbemycin oxyme and praziquantel, praziquantel, lufenuron, ivermectin, both ivermectin and pyrantel, lufenuron, levamizole, doxycycline or a dog appeasing pheromone ([0066], pg. 4, col. 1).
US’290 teaches that the solid compositions comprise of a palatable material. The palatable material provides a taste and an odor for the soft tablet, which is thus more accepted by the animal and thereby improving the compliance. The palatable material can be sweet and/or can derived from meat ingredients, or any natural, natural identical or artificial flavoring substances. It also comprises flavors such as essential oils, terpene derivatives (menthol), franeol, taste enhancers such as sodium glutamate, sweeteners such as aspartame, sodium saccharin, maltol, polyols such as sorbitol, isomalt, maltitol, mannitol, and lactitol. In a preferred embodiment, the “soft tablet” comprises without limitation at least one palatable chosen from among meat, meat powders, fish powders, cheese powders, milk derivatives, liver powder, the extracts of these animal substances or their derivatives, yeasts, yeast extracts such as beer yeast, vegetable fibers, vegetable products and by-products such as malt extracts, fenugreek, apple, carrot, fodder beet, sugar beet, thyme, alfalfa, sugar cane, cereals such as oats, wheat, rice, corn, soy, their derivatives such as flours and a mixture thereof, crystallized sugar, powder sugar glucose, invert sugar, molasses, caramel, honey and its derivatives, sodium chloride, and a mixture thereof. In a preferred embodiment, the palatable material is a pig liver powder, a chicken liver flavor, a chicken flavor, yeast extract, malt extract, and a mixture thereof ([0069], pg. 4, col. 1).
US’290 teaches that the humectant is chosen from among propylene glycol, glycerin, sorbitol, polyethylene glycol, and liquid oils such as soya bean oil, peanut oil, olive oil, groundnut oil, rapeseed oil, sunflower oil, palm oil, coconut oil, peanut oil, fish oil, and a mixture thereof ([0071], pg. 4, col. 2). US’290 teaches that the binder is chosen from among polyvinyl alcohol polymers, polyvinylpyrrolidone, the copolymers of vinylpyrrolidone and vinyl acetate, maltodextrin, carboxymethylcellulose, its salts and derivatives, alginic acid and its salts, zein, pectins, arabic gum, acacia gum, tragacanth gum, karaya gum, xanthan gum, guar gum, carrageenans, gelatin, pullulan polymers, agar polymers, starches and their derivatives, carbomers, acrylic acid cross-linked with polyalkenyl ethers, polycarbophils, and a mixture thereof. In a more preferred embodiment, the binder is chosen from among maltodextrin, pregelatinized starch, xanthan gum, guar gum, and a mixture thereof ([0072], pg. 4, col. 2).
US’290 teaches that the filler is chosen from among maltodextrin, cyclodextrin, lactose, talc, silica, silicates, phosphates, cellulose, cellulose powder, microcrystalline cellulose, croscarmellose, mica, carbonates, sugar (polysaccharides), and a mixture thereof. In a more preferred embodiment, the filler is chosen from among cellulose, microcrystalline cellulose, lactose, sugar, and a mixture thereof ([0074], pg. 4, col. 2). US’290 teaches that the disintegrant is croscarmellose, crosspovidone, starch, sodium starch glycolate and a mixture thereof ([0075], pg. 4, col. 2).
US’290 teaches that the preservative is chosen from among parabens, benzoic acid, sodium benzoate, sorbic acid, potassium sorbate, and a mixture thereof ([0077], pg. 4, col. 2). US’290 teaches that the pH regulator is chosen from among citric acid, its salts and derivatives, sodium carbonates, delta glucono lactone, and a mixture thereof ([0081], pg. 5, col. 1). US’290 teaches that it will be understood that the excipients may have several functions. For instance, polyethylene glycol may be both a humectant and a lubricant, sugar may be both a palatable material and a filler, croscarmellose may be both a filler and a disintegrant, etc. ([0082], pg. 5, col. 1)
US’290 teaches that in a preferred embodiment, the “soft tablet” comprises milbemycin, milbemycin oxyme, both milbemycin oxyme and praziquantel, praziquantel, lufenuron, ivermectin, both ivermectin and pyrantel pamoate, lufenuron, levamizole, doxycycline or a dog appeasing pheromone, a palatable material chosen from among pig liver powder, chicken liver flavor, chicken flavor and yeasts, a humectant chosen from among propylene glycol, glycerin, sorbitol, polyethylene glycol, soya bean oil, and peanut oil, a binder chosen from among maltodextrin, pregelatinized starch, xanthan gum, and guar gum, a lubricant chosen from among polyethylene glycol 6000, magnesium stearate, and stearic acid, a filler chosen from among sugar, cellulose, and lactose, and a croscarmellose as disintegrant ([0083], pg. 5, col. 1).
US’290 exemplifies a soft tablet composition comprising Milbemycin and Praziquantel as active ingredients ([0152], pg. 7, col. 2).
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It would have been prima facie obvious to combine the teachings of US’008 with US’290 by using liver powder such as pig liver powder, chicken liver flavor, etc. taught by US’290 ([0069], pg. 4, col. 1) in the place of artificial beef flavor in the Example 4 of US’008 to arrive at the instantly claimed invention. It would have been obvious for one of ordinary skill in the art to use the liver powder of US’290 as the flavoring agent in US’008 with a reasonable expectation of success because US’290 teaches that the flavoring agent provides a taste and an odor to the formulation, which makes it more acceptable to the animal and thereby improving the compliance ([0069], pg. 4, col. 1).
Regarding claim 3, the animal- derived flavoring agent is chicken liver powder, pork liver powder, beef liver powder, ham, fish, or a combination thereof, the claim limitations are met as US’290 teaches the palatable material is a pig liver powder, a chicken liver flavor, a chicken flavor, yeast extract, malt extract, and a mixture thereof ([0069], pg. 4, col. 1).
Regarding claim 4, the chicken- liver comprises about 8% to about 14% of the soft chewable veterinary formulation, it would have been obvious to combine the teaching of US’008 with US’290 before the effective filing date of the claimed invention by selecting chicken liver powder as a preferred animal-derived flavorant for the soft chewable formulation to arrive at the instantly claimed invention as US’290 teaches the palatable material is a pig liver powder, a chicken liver flavor, a chicken flavor, yeast extract, malt extract, and a mixture thereof ([0069], pg. 4, col. 1), and it would have been prima facie obvious further for one of ordinary skill in the art to optimize the amount of the preferred animal-derived flavorant, chicken liver powder to ensure the palatability of the soft chewable formulation with active ingredients whose taste needs to be masked for effective administration. One of ordinary skill in the art would have a reasonable expectation of success as US’290 teaches that the palatable material provides a taste and an odor for the formulation, which is thus more accepted by the animal and thereby improving the compliance.
Regarding claims 18 and 19, it would have been prima facie obvious to combine the teachings of US’008 with US’290 by including an active ingredient that is moisture-sensitive and is an anti-parasitic active ingredient such as Milbemycin and Praziquantel as taught by US’290 ([0152], pg. 7, col. 2) in the place of carprofen of US’008 to arrive at the instantly claimed invention. It would have been obvious for one of ordinary skill in the art to use the Milbemycin and Praziquantel of US’290 as the moisture-sensitive, anti-parasitic active ingredients in US’008 with a reasonable expectation of success because US’290 teaches that their process is also advantageous when said pharmaceutical active substances are unstable and sensitive to moisture ([0055], pg. 3, col. 2) and that the active ingredient are compounds having antiparasitic activity against endoparasites and/or ectoparasites ([0064], pg. 3, col. 2).
Claims 36, 49, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0354593 (PTO-892) in view of US 2018/0169008 (IDS 03/26/2024).
US’593 teaches a palatable soft chew veterinary composition comprising at least one active agent, at least one binding agent, at least one disintegrant, at least one wetting agent, and at least one flavorant, and methods for controlling or treating a condition in an animal comprising administering the composition to said animal in need thereof (Abstract).
The palatable, soft chewable composition of US’593 comprises at least one active agent selected from the group consisting of an antiparasitic, anti-inflammatory, antipruritic, anti-emetic, and antibiotic agent ([0005], pg. 1, col. 1). US’593 teaches that the veterinary acceptable binding agent is selected from the group consisting of microcrystalline cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, ethyl cellulose, polyvinylpyrrolidone (e.g., povidone (Kollidon 25, 30, and 90) and co-povidone (Kollidon VA 64), polyethylene glycol, acacia, tragacanth gum, gelatin, sucrose, lactose (e.g., hydrous, anhydrous, monohydrate), xylitol, sorbitol, maltitol, corn starch, potato starch, carnauba wax, alginate, and mixtures thereof ([0012], pg. 3, col. 1). US’593 teaches that one veterinary acceptable disintegrant is selected from the group consisting of croscarmellose sodium, citric acid, and sodium starch glycolate, and mixtures thereof. In yet another aspect, at least one disintegrant is croscarmellose sodium ([0013], pg. 3, col. 1). US’593 teaches that one veterinary acceptable wetting agent is selected from the group consisting of hydrous and anhydrous solvents. Non-limiting examples of wetting agents include: water, glycerin, propylene glycol, polyethylene glycol, ethanol, polysorbate 80, triacetin, and mixtures thereof ([0014], pg. 3, col. 1). US’593 teaches that one veterinary acceptable flavorant is an artificial flavorant, natural flavorant, and mixture thereof. The artificial flavorant is selected from at least one of chicken, turkey, beef, pork, lamb, and fish. The natural flavorant is selected from at least one of chicken, turkey, beef, pork, lamb, and fish, which can be obtained from meat, meat products, organ meat (e.g., liver, kidney, and the like), and mixtures thereof ([0015], pg. 3, col. 1).
US’593 teaches a method for treating pain and inflammation in an animal, by administering a composition, wherein said composition comprises carprofen ([0023], pg. 4, col. 1). US’593 teaches that soft chewable composition comprises at least one veterinary acceptable wetting agent (i.e., humectant) and wetting agent(s) are present in the palatable soft chew composition at concentrations of about 15% w/w to about 40% w/w ([0051], pg. 7, col. 1 and 2). US’593 teaches that the palatable soft chewable composition comprises at least one flavorant. Natural flavorants include chicken, turkey, beef, pork, lamb, fish, egg, cheese, seafood, vegetable, and mixtures thereof. Yeast extracts are also included in the natural flavors. Natural meat flavorants can be obtained from meat, meat products, organ meat, yeast extracts, vegetable matter, and mixtures thereof. For example, an oral veterinary composition medication might include animal product-based flavorings such as dried or powdered meat and meat parts such as beef, pork, chicken, turkey, fish, and lamb; organ meats such as liver; meat meals, bone meals and ground bone; and animal-derived food such as casein, milk (which may include dry forms and lowered fat forms, such as dry skim milk), yogurt, gelatin, cheese and egg (collectively, “animal origin flavorings”) may be utilized. The flavorant can be added directly to the composition as part of the dry blend or it can be added to other dry ingredients (fillers) to prepare a flavorant admixture to be added to the dry blend. Various fillers known in the art may be used in the palatable soft chewable composition. Non-limiting examples of fillers include: starch (e.g., corn, potato, tapioca, and the like), sugars (e.g., sucrose, fructose, lactose, mannitol, and the like, including hydrous and anhydrous forms), gelatin, cellulose (e.g., methyl cellulose, ethyl cellulose, and the like), calcium phosphate, soy protein fines, corn cob, corn gluten meal, and the like, and mixtures thereof. The flavorant/filler admixture typically contains at least one flavorant at a concentration of about 10% w/w to about 40% w/w, based on total weight of the admixture. More typically, the flavorant(s) is at a concentration of about 15% w/w to about 30% w/w, based on total weight of the admixture ([0052], pg. 7, col. 2 and pg. 8, col. 1).
US’593 teaches that the palatable soft chew compositions comprising carprofen is useful for treating and preventing pain and inflammation in an animal, and more preferably in companion animals, particularly dogs. As is well known by skilled artisans (e.g., veterinarians), the canine species, i.e., dogs, especially older dogs, are very susceptible to chronic inflammatory processes such as degenerative joint disease. Carprofen is known to treat and prevent inflammatory processes and diseases in dogs by inhibiting the activity of inducible cyclo-oxygenase-2 (COX-2). Carprofen is a non-steroidal anti-inflammatory agent (NSAID). It has been used to treat and prevent inflammation and pain associated with arthritic symptoms. The inflammatory process itself may have a number of precipitating causes, including infectious agents, ischemia, antigen-antibody interactions, and thermal or other physical injury. The response to each of these causes is characteristically different, but they all have a strong commonality. Clinical symptoms include erythema, edema, tenderness and pain. Three distinct phases can be recognized, but each of these is mediated by different mechanisms. The first, acute transient phase involves local vasodilation and increased capillary permeability; the second, delayed, subacute phase involves infiltration of leukocytes and phagocytic cells; and the third, chronic proliferative phase involves tissue degeneration and fibrosis. NSAIDs as a therapeutic class of anti-inflammatory agents appear to act by inhibiting the enzymatic production and release of prostaglandins, which participate in the pathogenesis of inflammation and fever. In addition to anti-inflammatory actions, NSAIDs have analgesic, antipyretic, and platelet-inhibitory actions. They act by blocking the synthesis of prostaglandins by inhibiting cyclooxygenase, which converts arachidonic acid to cyclic endoperoxides, precursors of prostaglandins. Inhibition of prostaglandin synthesis accounts for their analgesic, antipyretic, and platelet-inhibitory actions; other mechanisms may contribute to their anti-inflammatory effects. Therefore, the veterinary compositions of the invention are of particular value in the treatment and prevention of pain and inflammation in animals, particularly dogs, for which purpose they may be administered orally ([0058], pg. 8, col. 2). US’593 teaches that the palatable soft-chew compositions containing carprofen were prepared and evaluated for palatability ([0066], pg. 10, col. 1).
US’593 exemplifies Example 1, which is listed below ([0067], pg. 10, col. 1).
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The teachings of US’593 differ from that of the instantly claimed invention in that US’593 does not teach the specific soft chewable formulation of the instantly claimed invention.
The teachings US’008 were as discussed above.
It would have been obvious to combine US’593 with US’008 before the effective filing date of the claimed invention by using the soft chewable formulation taught from the teachings of US’008 in the method of US’593 for treating disease, or inflammation and pain in a subject to arrive at the instantly claimed invention. With respect to the particular soft chewable formulation, US’008 teaches the inclusion of diluents, disintegrant, humectant, lipids, starches, carbohydrates, binders, preservatives, and palatability enhancers along with the pharmaceutically active ingredient as US’008 suggests that the palatability enhancers improve the taste of the material that is chewed, and that they may improve the palatability of the soft chewable formulations comprising bitter, acrid, obnoxious, unpleasant, or otherwise unpalatable nutritional or pharmaceutically active agents ([0059], pg. 4, col. 1). Therefore, one of ordinary skill in the art would have been motivated to use the soft chewable with the appropriate active ingredient as the veterinary compositions are of particular value in the treatment and prevention of pain and inflammation in animals, particularly dogs, for which purpose they may be administered orally.
It would have been prima facie obvious for one of ordinary skill in the art to modify the formulation of US’593 with all the necessary aspects of the formulation as taught by US’008 because US’008 teaches a soft-chewable dosage unit formulation comprising a highly palatable composition to patients.
One of ordinary skill in the art would have a reasonable expectation of success because the soft chewable formulation with active ingredients would be palatable to the subject in need, and would be able to treat the disease or inflammation that the subject is suffering from.
Conclusion
No claims are allowed.
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/JANAKI ANANTH MAHADEVAN/Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693