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 .
Formal Matters
Applicant’s response in the reply filed on 11 April 2026 is acknowledged and has been fully considered. Claims 1-19 are pending. Claims 4-17 are under consideration in the instant office action. Claims 1-3 and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 16 January 2025 is noted and the submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the references. A signed copy is attached herein.
Election/Restrictions
Applicant’s election of Group II (claims 4-17) in the reply filed on 11 April 2026 is acknowledged. Additionally, Applicant’s election of the species glycerin as the non-aqueous liquid carrier, gum Arabic as the binding agent, dried yeast as the solid excipient, and S-Adenosyl-L-methionine (SAMe) as the active agent in the reply filed on 011 April 2026 is also acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Objection to the title
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The title of the instant application is “SOFT CHEWS WITH LOW WATER ACTIVITY AND METHODS OF MANUFACTURING SAME”. The title should be brief but technically accurate and descriptive and should contain fewer than 500 characters. The title does not describe the inventive concept in a way highlighting what are the important components of the composition. The title “SOFT CHEWS WITH LOW WATER ACTIVITY AND METHODS OF MANUFACTURING SAME” can be applicable to any pharmaceutical or nonpharmaceutical compositions. The essential components of the composition are crucial for the invention and applicant should consider amending the title reflecting those essential ingredients, for example the active agent of interest. The title should to the minimum describe the generic content of the structures. Inasmuch as the words "new," "improved," "improvement of," and "improvement in" are not considered as part of the title of an invention, these words should not be included at the beginning of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues. Similarly, the articles "a," "an," and "the" should not be included as the first words of the title of the invention and will be deleted when the Office enters the title into the Office’s computer records, and when any patent issues.
Claim Objections
Claim 4 is objected to because of the following informalities: claim 4 recites “A soft chew produced by claim 1.” Claim 4 depends from a withdrawn method for manufacturing claim 1. Claim 4 should be written in independent form, for example in product-by-process format including the process steps as recited in claim 1. Appropriate correction is required.
Claims 11, 13, and 17 are objected to because of the following informalities: reciting the amounts claims 11 and 13 designate the amount recitations as w/w without parenthesis whereas claim 17 designates as (w/w) with parenthesis. For clarity and consistency reasons, the examiner recommends applicant amend to w/w. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: claim 14 recites “The soft chew of claim 5, wherein the active agent is heat-labile and/or moisture labile.” For clarity and consistency reasons, the examiner recommends applicant should be consistent in the use the hyphen in both recitations or not. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 11, 13, and 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites “The soft chew of claim 5, wherein the non-aqueous liquid carrier is about 10% to 30%.” The amount recitations in claim 9 renders the claim indefinite because the recitation lack a clear reference point for the percentages and it is not clear if the amount is in w/w, w/v, v/w, v/v, etc. It is unclear what the respective percentage is measured relative to-e.g., the total weight of the soft chew, the weight of the binding agent, the weight of the active agent, the weight of the solid excipient, or some other basis. For prior art rejection purposes, the amount is interpreted with respect to the total weight of the soft chew as w/w.
Claim 11 recites “The soft chew of claim 5, wherein the binding agent is about 1% to 10% w/w.” The amount recitations in claim 11 renders the claim indefinite because the recitation lack a clear reference point for the percentages. It is unclear what the respective percentage is measured relative to-e.g., the total weight of the soft chew, the weight of the non-aqueous carrier, the weight of the active agent, the weight of the solid excipient, or some other basis. For prior art rejection purposes, the amount is interpreted with respect to the total weight of the soft chew.
Claim 13 recites “The soft chew of claim 5, wherein the solid excipient is about 15% to 50% w/w.” The amount recitations in claim 13 renders the claim indefinite because the recitation lack a clear reference point for the percentages. It is unclear what the respective percentage is measured relative to-e.g., the total weight of the soft chew, the weight of the non-aqueous carrier, the weight of the binding agent, the weight of the active agent, or some other basis. For prior art rejection purposes, the amount is interpreted with respect to the total weight of the soft chew.
Claim 17 recites “The soft chew of claim 5, wherein the active agent is about 0.1% to about 25% (w/w).” The amount recitations in claim 17 renders the claim indefinite because the recitation lack a clear reference point for the percentages. It is unclear what the respective percentage is measured relative to-e.g., the total weight of the soft chew, the weight of the non-aqueous carrier, the weight of the binding agent, the weight of the solid excipient, or some other basis. For prior art rejection purposes, the amount is interpreted with respect to the total weight of the soft chew.
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.
Note: The claims are examined with respect to the elected species of glycerin as the non-aqueous liquid carrier, gum Arabic as the binding agent, dried yeast as the solid excipient, and SAMe as the active agent.
Claims 4-17 are rejected under 35 U.S.C. 103 as being unpatentable over Campbell et al. (US 2014/0295024) in view of Majumdar et al. (US 2017/0354593) and Guan et al. (US 2017/0027976) and as evidenced by Stramentioli et al. (Minerva Med., Dec 5; 66(83):4434-4442, 1975 abstract only provided).
Note: The evidentiary reference Stramentioli et al. is provided to prove that S-adenosyl-L-methionine (SAMe) is both an anti-inflammatory and analgesic agent. Stramentioli et al. disclose in the abstract that S-adenosyl-L-methionine (SAMe) always plays an important role in the metabolism of catecholamines. Since the importance of the latter in the inflammatory process has been reported by several Authors, we examined the effect of SAMe in various tests of acute inflammation (carrageenin and white egg oedema) and chronic inflammation (cotton pellet induced granuloma, adjuvant induced arthritis). Considering the positive results we have obtained and being aware that many drugs with antiinflammatory activity also have an antalgic activity, we examined the effects of a treatment with SAMe on animals subjected to analgesic tests: hot plate and stretching by acetic acid in mice.
Applicant Claims
Applicant claims a soft chew comprising a non-aqueous liquid carrier, a binding agent, a solid excipient, and an active agent, wherein the soft chew has water activity (aw) of about 0.6 or below. The elected species are glycerin as the non-aqueous liquid carrier, gum Arabic as the binding agent, dried yeast as the solid excipient, and SAMe as the active agent.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Campbell et al. teach flavor pre-blends for use in chewing gum to impart improved chew texture and flavor release. The flavor pre-blend includes hydrophilic and lipophilic ingredients (see abstract). Traditional chewing gum is made using bulking agents in the form of crystalline powders such as crystalline sugar, sorbitol, or mannitol. Chewing gum is generally designed to have a certain chew texture throughout the majority of the chew time. However, designing for a targeted chew texture is complicated by the fact that the temperature of the chewing gum at the initial bite occurs when the gum piece is at ambient temperature (.about.22 to 25.degree. C.). As the consumer continues to chew the gum piece, the gum reaches body temperature (37.degree. C.). If the gum composition is designed to chew soft ("just right" chew) in the initial bite, then as the temperature increases, the chewing gum may become softer than a "just right" chew during the later chew stage. Thus, to design for a targeted chew texture during the majority of the chew duration, the initial chew may be harder than ideal. In such an instance, the consumer expectation of soft chew and large flavor hit in the first bite is not completely met by traditional chewing gum compositions (see paragraph 0002). Disclosed herein are chewing gums comprising a gum base; optionally a bulk sweetener; and a flavor pre-blend comprising i) a sweetener syrup, ii) a particulate sweetener, iii) an emulsifier, and iv) a fat, a flavorant, a food acid or salt thereof, a high intensity sweetener, a sensate, or a combination thereof (paragraph 0036). The flavor pre-blend contains a combination of hydrophilic and lipophilic ingredients combined into a homogeneous mixture. The hydrophilic ingredients include sweetener syrup and humectants (e.g. corn syrup, maltitol syrup, glycerin, etc.) containing dissolved or wetted particulate sweetener (e.g., particulate sucrose, maltitol, mannitol, etc.) to increase the solids content or dry matter content of the syrup to increase viscosity. The hydrophilic ingredients are mixed with lipophilic ingredients, such as a fat, an emulsifier, flavorants, etc., to form the flavor pre-blend as a substantially homogeneous mixture. In some embodiments, the flavor pre-blend can be characterized as a flavor emulsion, particularly as an oil in water emulsion. In some embodiments, the flavor pre-blend also can be characterized as a suspension or dispersion (paragraph 0038). The texture of the chewing gum containing the flavor pre-blend provides a velvety chew that stays smooth over time versus corresponding chewing gum prepared without the flavor pre-blend. The soft chew texture is maintained for five minutes or greater from the initial chew, specifically 10 minutes or greater, and more specifically 15 minutes or greater (paragraph 0040) Exemplary fats for use in the flavor pre-blend include fats and oils of vegetable origin, animal origin, or a combination thereof. Suitable vegetable fats can include soybean, cottonseed, corn, almond, peanut, sunflower, rapeseed, olive, palm, palm kernel, illipe, shea, coconut, cocoa, cocoa butter, or a combination thereof. The forgoing vegetable fats can be hydrogenated to varying degrees as desired or separated by fractional crystallization. Suitable animal fats include dairy fats such as milk fat and butter. As used herein, the term "fat" refers to any lipid material and can be solid or liquid (e.g. oil). Exemplary lipid materials include triglycerides, fatty alcohols, fatty acids, or a combination thereof. The triglyceride is not limited although medium chain triglycerides, long chain triglycerides, and the like can be used. The melting point of the fat is not limited although fats having a melting point of about 36 to about 68.degree. C. can be used. Specific fats include hydrogenated palm oil, hydrogenated palm kernel oil, hydrogenated soybean oil, hydrogenated peanut oil, hydrogenated cottonseed oil, hydrogenated coconut oil, or a combination thereof (paragraph 0070). A fat can be present in the flavor pre-blend in an amount of about 2.5 to about 10 wt % based on the total weight of the flavor pre-blend, specifically about 5.0 to about 7.5, more specifically about 5.5 to about 7.0 wt %, and yet more specifically about 6.0 to about 6.75 wt % (paragraph 0071) The flavor pre-blend can also contain an emulsifier. As used herein "emulsifier" means a material that retards the separation of two immiscible liquids after they are mixed. Suitable emulsifiers for use in the flavor pre-blend can have an HLB value in the range of 1 to 22, specifically 11 to 17, and more specifically 4 to 8. Emulsifiers can be selected based on the type of the emulsion. In general, higher HLB emulsifiers that are water soluble/dispersible can be used in the continuous aqueous phase for preparing an oil in water emulsion while lower HLB emulsifiers can be used in the continuous lipophilic phase for preparing water in oil emulsions. Exemplary emulsifiers include distilled monoglycerides, lecithin, acetic acid esters of mono and diglycerides, citric acid esters of mono and diglycerides, lactic acid esters of mono and diglycerides, mono and diglycerides, polyglycerol esters of fatty acids, ceteareth-20, polyglycerol polyricinoleate, propylene glycol esters of fatty acids, polyglyceryl laurate, glyceryl cocoate, gum arabic, acacia gum, etc., or a combination thereof (paragraph 0072). The emulsifier can be present in the flavor pre-blend in an amount of about 0.01 to about 15 wt % based on the total weight of the flavor pre-blend, specifically about 1.0 to about 7.0 wt %, more specifically about 2.5 to about 5.0 wt %, yet more specifically about 2.75 to about 3.5 wt %, and still yet more specifically about 3.0 to about 3.25 wt % (paragraph 0074).The flavor pre-blend may optionally further comprise a hydrocolloid. Hydrocolloid materials can include naturally occurring materials such as plant exudates, seed gums, and seaweed extracts or they can be chemically modified materials such as cellulose, starch, or natural gum derivatives. Furthermore, hydrocolloid materials can include pectin, gum arabic, etc., or a combination thereof (paragraph 0075). The flavor pre-blend can contain the hydrocolloid in an amount to improve viscosity and stability of the blend. Exemplary amounts of hydrocolloid is about 1 to about 15 wt % based on the total weight of the flavor pre-blend, specifically about 4 to about 10 wt %, and more specifically about 6 to about 8 wt % (paragraph 0076). The flavor pre-blend may optionally further comprise a humectant. Exemplary humectants include glycerin, propylene glycol, polyethylene glycol, or a combination thereof. The humectant can be added to retard the loss of moisture and to retard crystallization of the particulate sweetener. The use of a humectant can increase the liquidity of the flavor pre-blend without adding moisture to the blend (paragraph 0077). The humectant can be present in an amount of about of about 0.1 to about 30 wt % based on the total weight of the flavor pre-blend, specifically about 2.5 to about 20 wt %, more specifically about 4.0 to about 15 wt %, yet more specifically about 5.0 to about 10 wt %, and still yet more specifically about 6.0 to about 9.0 wt % (paragraph 0078). Exemplary flavor modulators or potentiators include monoammonium glycyrrhizinate, licorice glycyrrhizinates, yeast extract, etc., or a combination thereof are included (paragraph 0084). The amount of flavor modulators, flavor potentiators, and flavorants used herein can be a matter of preference subject to such factors as the type of final product composition, the individual flavor, and the strength of flavor desired. Thus, the amount of flavoring can be varied in order to obtain the result desired in the final product and such variations are within the capabilities of those skilled in the art without the need for undue experimentation (see paragraph 0085). The moisture content of the chewing gum composition can be about 0.5 to about 10 wt % based on the total weight of the chewing gum, specifically about 1 to about 8 wt %, yet more specifically about 1.5 to about 5 wt %, and still yet more specifically about 2.5 to about 4 wt %. The water activity of the chewing gum composition can be about 0.1 to about 0.7, specifically about 0.2 to about 0.6, and more specifically, about 0.25 to about 0.5 (paragraph 0134). In an embodiment, tingling agents may be employed to provide a tingling, stinging or numbing sensation to the user. Tingling agents include, but are not limited to: Jambu Oleoresin or para cress (Spilanthes sp.), in which the active ingredient is Spilanthol; Japanese pepper extract (Zanthoxylum peperitum), including the ingredients known as Saanshool-I, Saanshool-II and Sanshoamide; perillartine; 4-(1-menthoxymethyl)-2-phenyl-1,3-dioxolane; black pepper extract (piper nigrum), including the active ingredients chavicine and piperine; Echinacea extract; Northern Prickly Ash extract; trans-pellitorin, and red pepper oleoresin; or a combination thereof (paragraph 0082). Exemplary functional ingredients for use in the flavor pre-blend include a breath freshener, a dental care component, an active, etc., or a combination thereof (paragraph 0086).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Campbell et al. do not specifically teach the amount of dried yeast in claim 13. This deficiency is cured by the teachings of Majumdar et al.
Majumdar et al. teach a palatable soft chew veterinary composition comprising: 1. a therapeutically effective amount of at least one active agent; 2. at least one binding agent; 3. at least one disintegrant, 4. at least one wetting agent, and 5. at least one flavorant (see claim 1). In one aspect of the invention is a palatable, soft chewable composition, wherein the at least one veterinary acceptable flavorant is an artificial flavorant, natural flavorant, and mixture thereof. In yet another aspect of the invention, the artificial flavorant is selected from at least one of chicken, turkey, beef, pork, lamb, and fish. In one aspect of the invention, 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. Flavorants can also include vegetable matter and yeast extracts, for example brewer's yeast (which the examiner notes is dry) and hydrolyzed vegetable protein. In yet another aspect of the invention, the palatable soft chew composition further comprises at least one veterinary acceptable flavor enhancer (paragraph 0015). A natural flavorant is defined as the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast (which the examiner notes is dry), herb, bark, bud, root, leaf or any other edible portions of a plant, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose primary function in food is flavoring rather than nutritional. 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. 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. 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 (paragraph 0052). “Animal”, as used herein, unless otherwise indicated, refers to an individual animal that is a mammal. Specifically, mammal refers to a vertebrate animal that is human and non-human, which are members of the taxonomic class Mammalia. Non-exclusive examples of non-human mammals include companion animals and livestock. Non-exclusive examples of a companion animal include: dog, cat, and horse. Preferred companion animals are dog and cat. More preferred is dog. Non-exclusive examples of livestock include: pig, llama, rabbits, goat, sheep, deer, elk, and cattle (paragraph 0027).
Campbell et al. and Majumdar et al. do not specifically teach S-adenosyl-L-methionine (SAMe) as an active agent and its amounts in the composition. This deficiency is cured by the teachings of Guan et al.
Note: S-adenosyl-L-methionine (SAMe) is an analgesic and an anti-inflammatory agent as evidenced by Stramentioli et al. Stramentioli et al. disclose in the abstract that S-adenosyl-L-methionine (SAMe) always plays an important role in the metabolism of catecholamines. Since the importance of the latter in the inflammatory process has been reported by several Authors, we examined the effect of SAMe in various tests of acute inflammation (carrageenin and white egg oedema) and chronic inflammation (cotton pellet induced granuloma, adjuvant induced arthritis). Considering the positive results we have obtained and being aware that many drugs with antiinflammatory activity also have an antalgic activity, we examined the effects of a treatment with SAMe on animals subjected to analgesic tests: hot plate and stretching by acetic acid in mice.
Guan et al. teach drinkable or edible compositions comprising ademetionine (“SAM-e” or “S-adenosyl-L-methionine”). Also provided herein are methods for improving the delivery of ademetionine. Compositions and formulations provided herein increase ademetionine appealability. Also provided herein are methods of treating a disease or disorder in a subject by administering drinkable or edible compositions comprising ademetionine (see abstract). Drinkable or edible nutritional, pharmaceutical or veterinary products are becoming increasingly popular. In particular, the demand for shelf-stable beverages such as milkshakes or drink crystals, sprinkles, or powders is steadily rising as well as edible products such as snack bars, gels or other foods. Because of this, there is a need in the art for products and processes which improve, for example, the taste, texture and stability of such compositions (paragraph 0004). “Drinkable or edible compositions” as used herein are meant to include drinkable or edible dosage forms comprising ademetionine including solutions, suspensions (e.g. some milkshakes or drinks/beverages), slurries, slushies, smoothies, powders, drink crystals, sprinkles, teas, bubble teas, soups, and medicaments as well as other instant particulate dry mix forms for nutritional, pharmaceutical and/or veterinary use. “Edible compositions” include forms that may be ingested and which include ademetionine (i.e. other “foodstuffs”) including, but not limited to, gummies, gummy bears, gummy or chewy products (including carbohydrate and/or energy chews and/or gels), confectionary products, including bakers' confections and sugar confections such as candies, pastilles and sweets. “Chewy” products are meant to include those designed to be ingested as opposed to such non-ingestible chewy items such as chewing gum which may be designed for buccal delivery of agents (see paragraph 0006). In some embodiments, provided herein are edible or drinkable compositions and formulations comprising ademetionine and one or more gallic acid ester, wherein said composition comprises at least 10% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise at least 20% by weight ademetionine. In some embodiments, said compositions or formulations comprise at least 30% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise at least 40% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise at least 50% by weight ademetionine. In some embodiments, said c edible or drinkable compositions or formulations comprise at least 60% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise at least 70% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise at least 80% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise at least 90% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise from about 10 to 90% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise from about 5 to 10%, 10 to 15%, 15 to 20%, 20 to 25%, 25 to 30%, 30 to 35%, 35 to 40%, 40 to 50%, 50 to 60%, 60 to 70%, 70 to 80%, 80-90% or greater than 90% by weight ademetionine (paragraph 0017).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art at the time of the instant invention was filed to modify the teachings of to incorporate dried yeast in the soft chew composition of Campbell et al. because Majumdar et al. teach a palatable soft chew veterinary composition comprising: 1. a therapeutically effective amount of at least one active agent; 2. at least one binding agent; 3. at least one disintegrant, 4. at least one wetting agent, and 5. at least one flavorant (see claim 1). In one aspect of the invention is a palatable, soft chewable composition, wherein the at least one veterinary acceptable flavorant is an artificial flavorant, natural flavorant, and mixture thereof. In yet another aspect of the invention, the artificial flavorant is selected from at least one of chicken, turkey, beef, pork, lamb, and fish. In one aspect of the invention, 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. Flavorants can also include vegetable matter and yeast extracts, for example brewer's yeast (which the examiner notes is dry) and hydrolyzed vegetable protein. In yet another aspect of the invention, the palatable soft chew composition further comprises at least one veterinary acceptable flavor enhancer (paragraph 0015). A natural flavorant is defined as the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast (which the examiner notes is dry), herb, bark, bud, root, leaf or any other edible portions of a plant, meat, seafood, poultry, eggs, dairy products, or fermentation products thereof, whose primary function in food is flavoring rather than nutritional. 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. 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. One of ordinary skill in the art would have been motivated to include dried yeast because as a flavoring agent and as conventionally known can provide a desired flavor to the soft chew composition. In terms of the amount Majumdar et al. clearly teach that 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 (paragraph 0052). “Animal”, as used herein, unless otherwise indicated, refers to an individual animal that is a mammal. Specifically, mammal refers to a vertebrate animal that is human and non-human, which are members of the taxonomic class Mammalia. Non-exclusive examples of non-human mammals include companion animals and livestock. Non-exclusive examples of a companion animal include: dog, cat, and horse. Preferred companion animals are dog and cat. More preferred is dog. Non-exclusive examples of livestock include: pig, llama, rabbits, goat, sheep, deer, elk, and cattle (paragraph 0027). Furthermore, one of ordinary skill in the art would have been motivated to substitute the flavoring agents used by Campbell et al. with the flavoring agents provided by Majumdar et al. because the flavoring agents are functionally equivalent and can be interchangeably used to provided a desired flavor to the composition. 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). In the case where the claimed ranges for amounts of ingredients "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, a prima facie case of obviousness exists because differences in concentration and temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. It is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05 and 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 of success in combining the teachings of Campbell et al. and Majumdar et al. because both references teach soft chew compositions comprising active agents and flavoring agents.
It would have been prima facie obvious to a person of ordinary skill in the art at the time of the instant invention was filed to modify the teachings of Campbell et al. because Majumdar et al. by incorporating S-adenosyl-L-methionine (SAMe) as an active agent and its amounts in a soft chew composition because Guan et al. teach drinkable or edible compositions comprising ademetionine (“SAM-e” or “S-adenosyl-L-methionine”). Also provided herein are methods for improving the delivery of ademetionine. Compositions and formulations provided herein increase ademetionine appealability. Also provided herein are methods of treating a disease or disorder in a subject by administering drinkable or edible compositions comprising ademetionine (see abstract). Drinkable or edible nutritional, pharmaceutical or veterinary products are becoming increasingly popular. In particular, the demand for shelf-stable beverages such as milkshakes or drink crystals, sprinkles, or powders is steadily rising as well as edible products such as snack bars, gels or other foods. Because of this, there is a need in the art for products and processes which improve, for example, the taste, texture and stability of such compositions (paragraph 0004). “Drinkable or edible compositions” as used herein are meant to include drinkable or edible dosage forms comprising ademetionine including solutions, suspensions (e.g. some milkshakes or drinks/beverages), slurries, slushies, smoothies, powders, drink crystals, sprinkles, teas, bubble teas, soups, and medicaments as well as other instant particulate dry mix forms for nutritional, pharmaceutical and/or veterinary use. “Edible compositions” include forms that may be ingested and which include ademetionine (i.e. other “foodstuffs”) including, but not limited to, gummies, gummy bears, gummy or chewy products (including carbohydrate and/or energy chews and/or gels), confectionary products, including bakers' confections and sugar confections such as candies, pastilles and sweets. “Chewy” products are meant to include those designed to be ingested as opposed to such non-ingestible chewy items such as chewing gum which may be designed for buccal delivery of agents (see paragraph 0006). One of ordinary skill in the art would have been motivated to do so because first Guan et al. teach that Ademetionine (also referred to as “S-adenosyl-L-methionine”, “SAM” or “SAMe”) is a naturally occurring compound that is present in almost every tissue throughout the body. Aside from water, ademetionine is considered the second most common metabolic molecule-adenosine triphosphate (ATP) being the most common. Ademetionine is available as an over-the-counter dietary supplement in a number of countries and by prescription in Europe. Supplementation with ademetionine has been tested and showed efficacious for the treatment of various ailments, including arthritis, Alzheimer's, liver disease and depression. Unfortunately, however, the uptake of ademetionine is very low (<5%) and therefore large doses are required daily. Thus, there is a need for enhancing the mode of delivery of ademetionine (paragraph 0003). In some embodiments, provided herein are edible or drinkable compositions and formulations comprising ademetionine and one or more gallic acid ester, wherein said composition comprises at least 10% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise at least 20% by weight ademetionine. In some embodiments, said compositions or formulations comprise at least 30% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise at least 40% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise at least 50% by weight ademetionine. In some embodiments, said c edible or drinkable compositions or formulations comprise at least 60% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise at least 70% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise at least 80% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise at least 90% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise from about 10 to 90% by weight ademetionine. In some embodiments, said edible or drinkable compositions or formulations comprise from about 5 to 10%, 10 to 15%, 15 to 20%, 20 to 25%, 25 to 30%, 30 to 35%, 35 to 40%, 40 to 50%, 50 to 60%, 60 to 70%, 70 to 80%, 80-90% or greater than 90% by weight ademetionine (paragraph 0017). This teachings clearly covers the limitations of claims 14-16. To make the record clear Applicant’s specification also teach SAMe as heat labile and/or moisture labile drug (see page 9). Furthermore, S-adenosyl-L-methionine (SAMe) is an analgesic and an anti-inflammatory agent as evidenced by Stramentioli et al. Stramentioli et al. disclose in the abstract that S-adenosyl-L-methionine (SAMe) always plays an important role in the metabolism of catecholamines. Since the importance of the latter in the inflammatory process has been reported by several Authors, we examined the effect of SAMe in various tests of acute inflammation (carrageenin and white egg oedema) and chronic inflammation (cotton pellet induced granuloma, adjuvant induced arthritis). Considering the positive results we have obtained and being aware that many drugs with antiinflammatory activity also have an antalgic activity, we examined the effects of a treatment with SAMe on animals subjected to analgesic tests: hot plate and stretching by acetic acid in mice. Therefore, the limitations of claims 14-16 are clearly covered. Furthermore, it should be noticed that Campbell et al. teach that an active agent (in general) can be incorporated in its composition. Exemplary functional ingredients for use in the flavor pre-blend include a breath freshener, a dental care component, an active, etc., or a combination thereof (paragraph 0086). In the case where the claimed ranges for amounts of active agent "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, a prima facie case of obviousness exists because differences in concentration and temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. It is not inventive to discover the optimum or workable ranges by routine experimentation" (see MPEP 2144.05 and 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 of success in combining the teachings of Campbell et al., Majumdar et al., and Guan et al. because all of the references teach soft chew compositions comprising active agents and flavoring agents.
With regard to the limitation of instant claim 4, it is written in product-by-process format. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020) ("Biogen is certainly correct that the scope of composition and method of treatment claims is generally subject to distinctly different analyses. But where, as here, the novelty of the method of administration rests wholly on the novelty of the composition administered, which in turn rests on the novelty of the source limitation, the Amgen analysis will necessarily result in the same conclusion on anticipation for both forms of claims."); United Therapeutics Corp. v Liquidia Techs., Inc., 74 F.4th 1360, 1373, 2023 USPQ2d 862 (Fed. Cir. 2023) (the court held that product-by-process claims were properly rejected as "anticipated by a disclosure of the same product irrespective of the processes by which they are made."); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id. at 1370 ("a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim").
With regard to the property limitations recited in claims 5 and 7, the combination teachings of Campbell et al, Majumdar et al., and Guan et al. taught substantially similar and/or identical product. Therefore, any functional or structural properties that are recited in claims 5 and 7 would necessarily be present. "In relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." Ex parte Levy, 17 USPQ2d 1461, 1464 (Bd. Pat. App. & Inter. 1990) (emphasis in original). In PAR Pharmaceutical, Inc. v. TWI Pharmaceuticals, Inc., 773 F.3d 1186, 112 USPQ2d 1945 (Fed. Cir. 2014), the Federal Circuit remanded a decision to the district court because the record did not present sufficient evidence to prove inherency in the context of obviousness. The district court concluded the pharmacokinetic parameters of a claim are inherent properties of the obvious formulation. The Federal Circuit stated that while "inherency may support a missing claim limitation in an obviousness analysis", "the use of inherency, a doctrine originally rooted in anticipation, must be carefully circumscribed in the context of obviousness." Id. at 1194-95, 112 USPQ2d at 1952. "[I]n order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis – the limitation at issue necessarily must be present, or the natural result of the combination of elements explicitly disclosed by the prior art." Id. at 1195-96, 112 USPQ2d at 1952. But see, Persion Pharms. LLC v. Alvogen Malta Operations LTD., 945 F.3d 1184, 1191, 2019 USPQ2d 494084 (Fed. Cir. 2019), where the court stated that a proper finding of inherency does not require that all limitations are taught in a single reference, and that inherency may meet a missing claim limitation when the limitation is "the natural result of the combination of prior art elements." (emphasis in original). The court found that pharmacokinetic limitations of the asserted claims were inherently met by combining prior art references because the limitations were necessarily present in the prior art combination. Id. See also Hospira, Inc. v. Fresenius Kabi USA, LLC, 946 F.3d 1322, 1329-32, 2020 USPQ2d 6227 (Fed. Cir. 2020).
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious 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 invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusions
No claims are allowed.
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/TIGABU KASSA/
Primary Examiner, Art Unit 1619
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