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 .
Election/Restrictions
Claims 15-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group II and III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/03/2025.
Applicant's election with traverse of Group I claims 1-14 in the reply filed on 12/03/2025 is acknowledged. The traversal is on the ground(s) that there is no burden to the Examiner in examining the composition, the method of making, and the method of using. This is not found persuasive because the search burden for a method of using, a method of making and a composition is high, a method of making is not a composition nor is it a method of using. The methodology behind the search strategy and the sources searched for each category of invention is functionally different. There is a burden in doing all three inventions in one office action. Furthermore, the number of possible variations and combinations between and within phases and variations does provide a search burden in finding applicable prior art. With a wide range of possibilities, the prior art can end up being overly broad to cover more variations and phases or there can be a great many rejections to cover each individual permutation that must be made or the Examiner may probe deeply into a variation that is not of importance to the Applicant, reducing compact prosecution. With one variation to use as the Applicant’s desired starting point the prior art can be more carefully considered and more deeply searched for the variation the Applicant elects.
The requirement is still deemed proper and is therefore made FINAL.
Priority
The instant application is a 371 of PCT/BR2020/050018 filed on 01/29/2020/
Information Disclosure Statement
The information disclosure statement (IDS) dated 07/28/2022 complies with provisions of 37 CFR 1.97, 1.98 and MPEP §609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits.
Drawings
The drawings are objected to because the drawings are blurry, the labels are blurry, and some of the drawings are not in English. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: grammar and punctuation. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: punctuation. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: punctuation. Appropriate correction is required.
Claim Interpretation
With regards to claim 1n, the term “from organic sources or not” is interpreted as all sources of calcium.
With regards to claim 7, the term “a microlyzed form, in nanometic scale” the term nanometric scale is interpreted as measurements on the scale of nanometers. However, any measurements may be made in nanometers as an example 1 meter is also 100 centimeter is 1000 millimeters is 1,000,000,000 nanometers.
Claim Rejections - 35 USC § 112b
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 1-14 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.
Claims 1-14 are rejected as failing to define the invention in the manner required by 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
The claim(s) are narrative in form and replete with indefinite language. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited.
Examples of indefinite language include but are not limited too;
Regarding claim 1d, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Regarding claim 1f, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05.
Regarding claim 1i, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05.
Regarding claim 1j, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1k recites the broad recitation essential oils, and the claim also recites “(mint, peppermint, spearmint, lemon grass, clove, salvia, strawberry, grape, eucalyptus, marjoram, cinnamon, lemon, rosemary-pepper, orange)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 1l, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1m recites the broad recitation basics and acids, and the claim also recites “(mono- and di-sodium phosphates)” and “(phosphoric, citric, maleic)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 1o, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05.
Regarding instant claim 1, the minimum total percent of claim 1 recites 56.001%, which is less than a 100%.
Regarding instant claim 2, the minimum total percent of claim 2 recites 147.4%, which is greater than a 100%.
Regarding instant claim 3, the minimum total percent of claim 3 recites 143.5%, which is greater than a 100%.
The term “as needed” in claim 3 xiv is a relative term which renders the claim indefinite. The term “as needed” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what amount of acid and/or base is required.
Regarding instant claim 4, the minimum total percent of claim 4 recites 55.8%, which is less than 100%.
Claim 5 recites the limitation "wherein the variations are:" in line 4. There is insufficient antecedent basis for this limitation in the claim. The term “variations “is used however only one variant is disclosed.
Regarding instant claim 5, the minimum total percent of claim 5 recites 30.51%, which is less than a 100%.
Claim 6 recites the limitation "wherein its variations comprise:" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. The term “variations “is used however only one variant is disclosed.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites the broad recitation aqueous medium, and the claim also recites “(mouth)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Regarding claim 11, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05.
Regarding claim 12, the phrase "especially" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05.
Claim Rejections - 35 USC § 112d
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 7-14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 7-8 and 11-14 depend from claims 1 or 5. However claim 5 is also a multiple dependent claim, claim 5 recites “any one of claims 1, 2, 3 or 4”, it is improper to depend a multiple dependent claim from a multiple dependent claim. Claims 9-10 depend from claim 8 which is an improper multiple dependent claim and are therefore also improperly dependent. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Vermeer (US Patent 5,624,906A).
Vermeer teaches that oral hygiene compositions are available in a variety of types and forms. A classification according to product type includes, but is not limited to mouthwashes, pre-brushtng dental rinses, post-brushing dental rinses, dental sprays, dental creams, toothpastes, toothpaste gels, toothpowders, dental cleansers, dental flosses, chewing gums, lozenges and the like. Preferred are the mouthwashes, pre-brushing dental rinses, post-brushing dental rinses, toothpastes and toothpaste gels. A classification according to product form would consist of aerosol, liquid, gel, cream, paste, granular, tablet or powdered form. Preferred product form for mouthwashes, pre-brushing dental rinses and postbrushing dental rinses of the invention is liquid form. Preferred product form for denaces (toothpastes) of the invention is gel or paste form (Vermeer at column 46).
Vermeer teaches examples of humectants useful in the present invention which serve to add body or mouth feel to a mouthwash or dental rinse composition and retain moisture in a dentifrice composition include polyethylene polyethylene glycol-400 (PEG-8), polyethylene glycol-450 (PEG-9), polyethylene glycol-500 (PEG-10), polyethylene glycol-600 (PEG-12), propylene glycol (PG), glycerol (glycerin), erythritol, xylitol, sorbitol, mannitol, lactitol, hydrogenated starch hydrolyzates and mixtures thereof. In addition, humectants help prevent microbial deterioration during storage of oral hygiene composition, assist in maintaining phase stability and provide a means to formulate a transparent or translucent dentifrice. Preferred humectants are PEG-6, PEG-8, PEG-12, PEG-32, glycerin, sorbitol, hydrogenated starch hydrolyzates and mixtures thereof. Most highly preferred humectants are glycerin, sorbitol, hydrogenated starch hydrolyzates and mixtures thereof as described in U.S. Pat. No. 4,435,380 which is incorporated herein by reference. Typical levels of humectant are from about 0% to about 80% by weight of a composition. (Vermeer at columns 17-18). Vermeer teaches examples of binders/cothickeners (stabilizing agents) useful in the dentifrice compositions of the present invention which provide gelatinous structure, paste firmness, mouth feel benefits and stabilize the toothpaste mass against liquid phase separation include starch, glycerite of starch, gum karaya (sterculia gum), gum tragacanth, gum arabic, gum ghatti, gum acacia, locust bean gum, xanthan gum, guar gum, veegum, irish moss extract (chondrus extract), irish moss (carrageenan), sodium alginate, agar-agar, pectin, gelatin, cellulose, cellulose gum, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxymethyl carboxymethyl cellulose, hydroxymethyl carboxypropyl cellulose, methyl cellulose, ethyl cellulose, sulfated cellulose, polyacrylate, polyvinylpyrrolidone (PVP), silicate clays, silica precipitates, silica aerogels, pyrogenic silicas, colloidal magnesium aluminum silicate and mixtures thereof. Preferred binders/thickeners are those which are hydrophilic colloids that disperse as well as absorb water to form a viscous liquid phase, such as the silicas, carrageenan, hydroxyethyl cellulose, cellulose gum, xanthan gum, veegum, polyacrylates and mixtures thereof. Most highly preferred binders/thickeners are cellulose gum and xanthan gum. Typical levels of binders/thickeners are from about 0% to about 30% by weight of a composition. (Vermeer at column 18). Vermeer teaches that when water is employed in the oral hygiene compositions of the present invention, it should be deionized and free of organic impurities. Water is generally present from about 1% to about 95%, preferably from about 45% to about 90%. (Vermeer at column 38). Vermeer teaches fluorides useful in the present invention which serve to prevent dental caries include sodium fluoride, potassium fluoride, calcium fluoride, zinc fluoride, stannous fluoride, zinc ammonium fluoride, sodium monofluorophosphate, potassium monofluorophosphate, laurylamine hydrofluoride, diethylaminoethyloctoylamide hydrofluoride, 1-ethanol-2-hexadecylimidazoline dihydrofiuoride, dodecyltrimethylammonium fluoride, tetraethylammonium fluoride, didecyldimethylammonium fluoride, cetylpyridinium fluoride, dilaurylmorpholinium fluoride, N-carboxymethyl-N-dodecyldiethylammonium fluoride, sarcosine stannous fluoride, glycine potassium fluoride, glycine hydrofluoride, sodium monofluorophosphate and mixtures thereof. Preferred fluorides are sodium fluoride, potassium fluoride, sodium monofluorophosphate, potassium monofluorophosphate, stannous fluoride and mixtures thereof. Most highly preferred fluorides are sodium fluoride, sodium monofluorophosphate arid mixtures thereof. Typical levels of fluoride are from about 0% to about 5% by weight of the composition. (Vermeer at column 37). Vermeer teaches sweeteners useful in the present invention which may be employed to round out the overall taste of the product include saccharin (as sodium, potassium or calcium saccharin), cyclamate (as sodium, potassium or calcium cyclamate), ASPARTAME®, acesulfane-K, thaumatin, neohisperidin dihydrochalcone, ammoniated glycyrrhizin, dextrose, levulose, sucrose, D-tryptophan, miraculin, NUTRASWEET, mannose, glucose, α-D-glucose, β-D-glucose, lactose, galactose and mixtures thereof. Both artificial and natural sweeteners may be used to add further sweetness than that provided by the essential flavoring oils. A preferred sweetener is the potassium or sodium salts of saccharin. Typical levels of sweetener are from about 0.01% to about 4% by weight of the composition (Vermeer at column 37). Vermeer teaches Examples of antibacterial agents useful in the present invention which are known to be active against a wide variety of microorganisms at levels below those known to be harmful include phenolic compounds such as betanapthol, chlorothymol, thymol, anethole, eucalyptol, carvacrol, menthol, phenol, amylphenol, hexylphenol, heptylphenol, octylphenol, hexylresorcinol, hexachlorophene [2,2-methylene bis(3,4,6-trichlorophenol)], chlorhexidine [1,1'-hexamethylene bis(5-)p-chlorophenyl)bigauanide)], chlorhexidine diacetate, chlorhexidine dihydrochloride, chlorhexidine digluconate, chlorhexidine dfiactobionate, chlorhexidine dimaltobionate and methyl snlicylate; quaternary ammonium salt compounds such as morpholinium tetradecylsulfate, laurylpyridinium chloride, myristylpyridinium chloride, cetylpyridinium fluoride, cetylpyridinium chloride, cetylpyridinium bromide, cetylpyridinium iodide, stearylpyridinium chloride, dodecyltrimethylammonium chloride, tetradecyltrimethylammonium chloride, hexadecyltrimethylammonium bromide, C12 -C16 benzyldimethylammonium chloride (benzethonium chloride), phenoxyethyldodecyldimethylammonium bromide (domiphen bromide), triclobisonium chloride; as well as benzoic acid, sodium benzoate, potassium benzoate boric acid, tyrothricin, granicidin, sanguinarine chloride and -mixtures thereof. Preferred antibacterial agents include thymol, anethole, eucalyptol, menthol, cetylpyridinium chloride, benzoic acid, sodium benzoate, boric acid, domiphen bromide and chlorhexidine gluconate. Most highly preferred antibacterial agents are cetylpyridinium chloride, benzoic acid, sodium benzoate and domiphen bromide. Typical levels of antibacterial agent are from about 0% to about 5% by weight of the composition (Vermeer at columns 35-36). Vermeer teaches alkali metal halides (salts) useful in the present invention include sodium chloride, potassium chloride, potassium iodide, ammonium chloride,chromium chloride, calcium chloride, magnesium chloride, sodium sulfate, potassium sulfate, magnesium sulfate, nickelous sulfate, sodium metavanadate and sodium selenate. Preferred alkali metal halides are sodium chloride, potassium chloride and mixtures thereof. The alkali metal halide salt compounds serve as an electrolyte and contributes to the overall flavor. Typical levels of alkali metal halide salt are from about 0% to about 5% by weight of the composition (Vermeer at column 36). Vermeer teaches abrasive polishing agents (body agents) useful in the dentifrice compositions of the present invention which function to remove debris and residual stains from the teeth as well as polish the tooth surface include calcium carbonate, precipitated calcium carbonate, light calcium carbonate, medium calcium carbonate, dense calcium carbonate, extra dense calcium carbonate, sodium carbonate, sodium bicarbonate (baking soda), potassium carbonate, potassium bicarbonate, anhydrous calcium phosphate, dicalcium phosphate, dibasic calcium phosphate dihydrate, tribasic calcium phosphate, sodium phosphate, potassium phosphate, calcium pyrophosphate, insoluble sodium metaphosphate, disodium orthophosphate, dibasic sodium phosphate, magnesium hydroxide, magnesium carbonate, magnesium silicate, magnesium trisilicate, trimagnesium phosphate, monomagnesium phosphate, magnesium oxide, stannic oxide, zinc oxide, chalk, extra light chalk, light chalk, medium chalk, course chalk, bentonite, flour of pumice, a-alumina trihydrate, levigated alumina, hydrated alumina, alumina aerogel, gelatinous alumina, aluminum silicate, calcined aluminum silicate, zirconium silicate, hydroxyapatite, crosslinked urea-formaldehyde resin, crosslinked melamine-formaldehyde resin, polymethacrylate, polymethylmethacrylate, polystyrene, powdered polyethylene, silica gel (hydrated silica), dehydrated silica gel (silica), silica precipitates, silica xerogel, silica hydrogels, silica pyrogel, silica aerogel and mixtures thereof. The average particle size of an abrasive polishing agent is from about 1 μm to about 20 μm, preferably from about 3 μm to about 12 μm. Preferred abrasive polishing agents include the silicas, sodium bicarbonate (baking soda), sodium carbonate, dicalcium phosphate, dibasic calcium phosphate dihydrate, tribasic calcium phosphate, sodium phosphate, calcium carbonate, α-alumina trihydrate and mixtures thereof. Most highly preferred abrasive polishing agents are hydrated silica and sodium bicarbonate. Typical levels of abrasive polishing agents are from about 0% to about 65% by weight of the composition (Vermeer at column 17). Vermeer teaches specific examples of alkyl ether sulfates useful in the present invention include sodium laureth-1 sulfate, sodium laureth-2 sulfate, sodium laureth-3 sulfate, (Vermeer at column 24) from about 0.02% to about 25% by weight of the composition is a cosuffactant (Vermeer at columns 42-35). Vermeer teaches preservatives or antimicrobial agents that function as bactericides and/or fungicides useful in the present invention include glutaraldehyde, formaldehyde, paraformaldehyde, glyoxal, benzoic acid, sodium benzoate, potassium benzoate, sodium methyl p-hydroxybenzoate, salicylic acid, sorbic acid, dehydroacetic acid, benzyl alcohol, ethanol, 2-phenoxyethanol, chlorohexidine hydrochloride, dichlorophene (2,2'-dihydroxy-5,5'-dichlorodiphenyl methane)triclosan, chloroacetamide, p-chloro-m-xylenol, 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride, methyl paraben, propyl paraben, butyl paraben, benzyl paraben, imidazolidiyl urea, diazolidinyl urea, monomethylol dimethyl hydantoin (MDM hydantoin), dimethylol dimethyl hydantoin (DMDM hydantoin), iodopropylnyl butylcarbamate, 2-bromo-2-nitropropane-1,3-diol, 2-octyl-4-isothiazolin-3-one, 5-chloro-2-methyl-4-isothiazolin-3-one (methylchloroisothiazoline), 2-methyl-4-isothiazolin-3-one (methylisothaizoline) and dicocodimethylammonium chloride. Preferred preservatives are the alkyl parabens, benzoic acid and their salts. Typical levels of preservative used to control bacterial action are from about 0% to about 2% by weight of the composition (Vermeer at columns 41-42). Vermeer teaches examples of essential flavorant oils useful in the present invention include oils of anise, irone, orris, caraway, clove, coriander, pimento, eucalyptus, eucalyptol, eugenol, nutmeg, thyme, peppermint, spearmint, wintergreen, cinnamon, cinnamon-mint, menthol, sassafras, anethole and mixtures thereof. Flavorant oils are added mainly to provide good flavor and favorable taste, however, some flavorant oils also provide antibacterial action. Preferred class of flavorant oil are peppermint, spearmint, wintergreen and mixtures thereof. Peppermint oil consists of a mixture of menthol, α-pinene, β-pinene, limonene, cineol, ethylamylcarbinol, methyl acetate, menthone, isomenthone, menthofuran, neomenthol, isomenthol and piperitone. Spearmint oil consists of a mixture of α-pinene, α-phellandr ene, limonene, octyl alcohol, dehydrocarveol, dipenlene cineol and carvene. Wintergreen oil consists mainly of methyl salicylate (wintergreen oil has been largely replaced with synthetic methyl salicylate). It should be noted that the specific choice of flavor is made on the basis that this class of flavor is highly desirable to the consuming public as representing and furnishing a fresh mouth feel as well as providing excellent persistent flavor notes effective for residual odor masking. The flavorant is characterized by containing major portions of menthol, carvene and methyl salicylate. Both natural and synthetic oils along with various flavor modifiers which give a distinctive note may be employed. Preferred flavor oils are peppermint, spearmint, wintergreen (as synthetic methyl salicylate) and mixtures thereof. Typical levels of flavorant oil are from about 0.01% to about 4% by weight of the composition (Vermeer at columns 36-37). Vermeer teaches examples of colorants (dyes) useful in the present invention include D&C blue #1, D&C blue #4, D&C brown #1, D&C green #5 through #8, D&C orange #4 through #11, D&C yellow #2 through #11, D&C red #6 through #40, FD&C blue #1, FD&C blue #2, FD&C blue #4, FD&C red #3, FD&C red #4, FD&C red #33, FD&C red #40, FD&C yellow #5, FD&C yellow #6, FD&C yellow #10, FD&C orange #4, FD&C green #3, carmine and mixtures thereof. Preferred colorants are FD&C blue #1, FD&C green #3, FD&C yellow #10 and mixtures thereof. Typical levels of colorant are from about 0% to about 2% by weight of the composition (Vermeer at column 38). Vermeer teaches examples of pH-control agents useful in the present invention include citric acid, tartaric acid, lactic acid, gluconic acid, lactobionic acid, glycolic acid, propionic acid, succinic acid, hydrochloric acid, phosphoric acid, nitric acid, sulfuric acid, formic acid, boric acid, acetic acid, benzoic acid, palmitic acid, stearic acid, sodium hydroxide, sodium carbonate, sodium bicarbonate, potassium hydroxide, potassium carbonate, potassium bicarbonate and mixtures thereof. The amount of pH-control agent used will be that which is sufficient to provide the desired pH. The pH of the present compositions may be in the range of about 3 to about 9 preferably from about 4 to about 8. The amount of pH-adjusting agent used will be that which is sufficient to provide the desired pH, typically from about 0.01% to about 3% by weight of the composition (Vermeer at column 41). Vermeer teaches examples of amino acids useful in the present invention include alanine, β-alanine, N-methylalantne, N-phenylalanine, α-aminoisobutyric acid, α-aminobutyric acid, α-aminocaproic acid, α-aminocaproic acid, glycine, N-ethylglycine, N-propylglycine, N-butylglycine, leueine, methionine, sareosine, serine, norvaline, tryptophan, lysine, aspattic acid, glutamic add, iminodiaeetic add, keratin amino acids and mixtures thereof. The sodium, potassium, ammonium or calcium salts of amino adds are useful as well and may be preferred in certain instances. Typical levels of amino acid are from about 0% to about 5% by weight of the composition. (Vermeer at columns 39-40). Vermeer teaches further examples of addition non-astringent anti-plaque and/or anti-calculus agents include the soluble pyrophosphate salts such as sodium trihydrogen pyrophosphate, disodium dihydrogen pyrophosphate, trisodium hydrogen pyrophosphate, trisodium hydrogen pyrophosphate monohydrate, trisodium hydrogen pyrophosphate nonahydrate, tetrasodium pyrophosphate. tetrasodium pyrophosphate decahydrate, potassium trihydrogen pyrophosphate, dipotassium dihydrogen pyrophosphate, tripotassium hydrogen pyrophosphate, tetrapotassium pyrophosphate, diammonium dihydrogen pyrophosphate, triammonium hydrogen pyrophosphate, triammonium hydrogen pyrophosphate monohydrate, calcium dihydrogen pyrophosphate, calcium pyrophosphate, tetraaluminium pyrophosphate and mixtures thereof. These compounds are more fully disclosed in U.S. Pat. Nos. 4,515,772, 4,515,772 and 4,627,977 all of which are incorporated herein by reference. Preferred soluble pyrophosphate salts are sodium trihydrogen pyrophosphate, disodium dihydrogen pyrophosphate, tetrasodium pyrophosphate, tetrapotassium pyrophosphate and mixtures thereof. Typical levels of soluble pyrophosphate salt are from about 0% to about 8% by weight of the composition (Vermeer at column 35).
Vermeer differs from the instant claims in this rejection insofar as it does not teach the combination of the instantly recited components with sufficient specificity for anticipation. Vermeer teaches the components of the instant recited composition and uses each component of their established function in the art but does not explicitly combine the components together into a single embodiment or a preferred composition. However, given the disclosure of each component individually, it would have been prima facie obvious to a person having ordinary skill in the art at a time prior to the filing of the present patent application and following the teachings of Vermeer to have selected and combined known components for their established functions with predictable results. MPEP §2143 and §2144.06(I).
Regarding instant claim 1,
Vermeer teaches examples of humectants useful in the present invention which serve to add body or mouth feel to a mouthwash or dental rinse composition and retain moisture in a dentifrice composition include polyethylene polyethylene glycol-400 (PEG-8), polyethylene glycol-450 (PEG-9), polyethylene glycol-500 (PEG-10), polyethylene glycol-600 (PEG-12), propylene glycol (PG), glycerol (glycerin), erythritol, xylitol, sorbitol, mannitol, lactitol, hydrogenated starch hydrolyzates and mixtures thereof. In addition, humectants help prevent microbial deterioration during storage of oral hygiene composition, assist in maintaining phase stability and provide a means to formulate a transparent or translucent dentifrice. Preferred humectants are PEG-6, PEG-8, PEG-12, PEG-32, glycerin, sorbitol, hydrogenated starch hydrolyzates and mixtures thereof. Most highly preferred humectants are glycerin, sorbitol, hydrogenated starch hydrolyzates and mixtures thereof as described in U.S. Pat. No. 4,435,380 which is incorporated herein by reference. Typical levels of humectant are from about 0% to about 80% by weight of a composition. (Vermeer at columns 17-18), which overlaps the instantly claimed range of 40 to 70%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of binders/cothickeners (stabilizing agents) useful in the dentifrice compositions of the present invention which provide gelatinous structure, paste firmness, mouth feel benefits and stabilize the toothpaste mass against liquid phase separation include starch, glycerite of starch, gum karaya (sterculia gum), gum tragacanth, gum arabic, gum ghatti, gum acacia, locust bean gum, xanthan gum, guar gum, veegum, irish moss extract (chondrus extract), irish moss (carrageenan), sodium alginate, agar-agar, pectin, gelatin, cellulose, cellulose gum, carboxymethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxymethyl carboxymethyl cellulose, hydroxymethyl carboxypropyl cellulose, methyl cellulose, ethyl cellulose, sulfated cellulose, polyacrylate, polyvinylpyrrolidone (PVP), silicate clays, silica precipitates, silica aerogels, pyrogenic silicas, colloidal magnesium aluminum silicate and mixtures thereof. Preferred binders/thickeners are those which are hydrophilic colloids that disperse as well as absorb water to form a viscous liquid phase, such as the silicas, carrageenan, hydroxyethyl cellulose, cellulose gum, xanthan gum, veegum, polyacrylates and mixtures thereof. Most highly preferred binders/thickeners are cellulose gum and xanthan gum. Typical levels of binders/thickeners are from about 0% to about 30% by weight of a composition. (Vermeer at column 18), which overlaps the instantly claimed range of 5 to 30%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches that when water is employed in the oral hygiene compositions of the present invention, it should be deionized and free of organic impurities. Water is generally present from about 1% to about 95%, preferably from about 45% to about 90%. (Vermeer at column 38), which overlaps the instantly claimed range of 0.1 to 7%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches fluorides useful in the present invention which serve to prevent dental caries include sodium fluoride, potassium fluoride, calcium fluoride, zinc fluoride, stannous fluoride, zinc ammonium fluoride, sodium monofluorophosphate, potassium monofluorophosphate, laurylamine hydrofluoride, diethylaminoethyloctoylamide hydrofluoride, 1-ethanol-2-hexadecylimidazoline dihydrofiuoride, dodecyltrimethylammonium fluoride, tetraethylammonium fluoride, didecyldimethylammonium fluoride, cetylpyridinium fluoride, dilaurylmorpholinium fluoride, N-carboxymethyl-N-dodecyldiethylammonium fluoride, sarcosine stannous fluoride, glycine potassium fluoride, glycine hydrofluoride, sodium monofluorophosphate and mixtures thereof. Preferred fluorides are sodium fluoride, potassium fluoride, sodium monofluorophosphate, potassium monofluorophosphate, stannous fluoride and mixtures thereof. Most highly preferred fluorides are sodium fluoride, sodium monofluorophosphate arid mixtures thereof. Typical levels of fluoride are from about 0% to about 5% by weight of the composition. (Vermeer at column 37), which overlaps the instantly claimed range of 0 to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of humectants useful in the present invention which serve to add body or mouth feel to a mouthwash or dental rinse composition and retain moisture in a dentifrice composition include polyethylene polyethylene glycol-400 (PEG-8), polyethylene glycol-450 (PEG-9), polyethylene glycol-500 (PEG-10), polyethylene glycol-600 (PEG-12), propylene glycol (PG), glycerol (glycerin), erythritol, xylitol, sorbitol, mannitol, lactitol, hydrogenated starch hydrolyzates and mixtures thereof. In addition, humectants help prevent microbial deterioration during storage of oral hygiene composition, assist in maintaining phase stability and provide a means to formulate a transparent or translucent dentifrice. Preferred humectants are PEG-6, PEG-8, PEG-12, PEG-32, glycerin, sorbitol, hydrogenated starch hydrolyzates and mixtures thereof. Most highly preferred humectants are glycerin, sorbitol, hydrogenated starch hydrolyzates and mixtures thereof as described in U.S. Pat. No. 4,435,380 which is incorporated herein by reference. Typical levels of humectant are from about 0% to about 80% by weight of a composition. (Vermeer at columns 17-18). Vermeer teaches sweeteners useful in the present invention which may be employed to round out the overall taste of the product include saccharin (as sodium, potassium or calcium saccharin), cyclamate (as sodium, potassium or calcium cyclamate), ASPARTAME®, acesulfane-K, thaumatin, neohisperidin dihydrochalcone, ammoniated glycyrrhizin, dextrose, levulose, sucrose, D-tryptophan, miraculin, NUTRASWEET, mannose, glucose, α-D-glucose, β-D-glucose, lactose, galactose and mixtures thereof. Both artificial and natural sweeteners may be used to add further sweetness than that provided by the essential flavoring oils. A preferred sweetener is the potassium or sodium salts of saccharin. Typical levels of sweetener are from about 0.01% to about 4% by weight of the composition (Vermeer at column 37), which overlaps the instantly claimed range of 0.5 to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches Examples of antibacterial agents useful in the present invention which are known to be active against a wide variety of microorganisms at levels below those known to be harmful include phenolic compounds such as betanapthol, chlorothymol, thymol, anethole, eucalyptol, carvacrol, menthol, phenol, amylphenol, hexylphenol, heptylphenol, octylphenol, hexylresorcinol, hexachlorophene [2,2-methylene bis(3,4,6-trichlorophenol)], chlorhexidine [1,1'-hexamethylene bis(5-)p-chlorophenyl)bigauanide)], chlorhexidine diacetate, chlorhexidine dihydrochloride, chlorhexidine digluconate, chlorhexidine dfiactobionate, chlorhexidine dimaltobionate and methyl snlicylate; quaternary ammonium salt compounds such as morpholinium tetradecylsulfate, laurylpyridinium chloride, myristylpyridinium chloride, cetylpyridinium fluoride, cetylpyridinium chloride, cetylpyridinium bromide, cetylpyridinium iodide, stearylpyridinium chloride, dodecyltrimethylammonium chloride, tetradecyltrimethylammonium chloride, hexadecyltrimethylammonium bromide, C12 -C16 benzyldimethylammonium chloride (benzethonium chloride), phenoxyethyldodecyldimethylammonium bromide (domiphen bromide), triclobisonium chloride; as well as benzoic acid, sodium benzoate, potassium benzoate boric acid, tyrothricin, granicidin, sanguinarine chloride and -mixtures thereof. Preferred antibacterial agents include thymol, anethole, eucalyptol, menthol, cetylpyridinium chloride, benzoic acid, sodium benzoate, boric acid, domiphen bromide and chlorhexidine gluconate. Most highly preferred antibacterial agents are cetylpyridinium chloride, benzoic acid, sodium benzoate and domiphen bromide. Typical levels of antibacterial agent are from about 0% to about 5% by weight of the composition (Vermeer at columns 35-36), which overlaps the instantly claimed range of 0.1 to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches alkali metal halides (salts) useful in the present invention include sodium chloride, potassium chloride, potassium iodide, ammonium chloride,chromium chloride, calcium chloride, magnesium chloride, sodium sulfate, potassium sulfate, magnesium sulfate, nickelous sulfate, sodium metavanadate and sodium selenate. Preferred alkali metal halides are sodium chloride, potassium chloride and mixtures thereof. The alkali metal halide salt compounds serve as an electrolyte and contributes to the overall flavor. Typical levels of alkali metal halide salt are from about 0% to about 5% by weight of the composition (Vermeer at column 36), which overlaps the instantly claimed range of 0.1 to 10%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches abrasive polishing agents (body agents) useful in the dentifrice compositions of the present invention which function to remove debris and residual stains from the teeth as well as polish the tooth surface include calcium carbonate, precipitated calcium carbonate, light calcium carbonate, medium calcium carbonate, dense calcium carbonate, extra dense calcium carbonate, sodium carbonate, sodium bicarbonate (baking soda), potassium carbonate, potassium bicarbonate, anhydrous calcium phosphate, dicalcium phosphate, dibasic calcium phosphate dihydrate, tribasic calcium phosphate, sodium phosphate, potassium phosphate, calcium pyrophosphate, insoluble sodium metaphosphate, disodium orthophosphate, dibasic sodium phosphate, magnesium hydroxide, magnesium carbonate, magnesium silicate, magnesium trisilicate, trimagnesium phosphate, monomagnesium phosphate, magnesium oxide, stannic oxide, zinc oxide, chalk, extra light chalk, light chalk, medium chalk, course chalk, bentonite, flour of pumice, a-alumina trihydrate, levigated alumina, hydrated alumina, alumina aerogel, gelatinous alumina, aluminum silicate, calcined aluminum silicate, zirconium silicate, hydroxyapatite, crosslinked urea-formaldehyde resin, crosslinked melamine-formaldehyde resin, polymethacrylate, polymethylmethacrylate, polystyrene, powdered polyethylene, silica gel (hydrated silica), dehydrated silica gel (silica), silica precipitates, silica xerogel, silica hydrogels, silica pyrogel, silica aerogel and mixtures thereof. The average particle size of an abrasive polishing agent is from about 1 μm to about 20 μm, preferably from about 3 μm to about 12 μm. Preferred abrasive polishing agents include the silicas, sodium bicarbonate (baking soda), sodium carbonate, dicalcium phosphate, dibasic calcium phosphate dihydrate, tribasic calcium phosphate, sodium phosphate, calcium carbonate, α-alumina trihydrate and mixtures thereof. Most highly preferred abrasive polishing agents are hydrated silica and sodium bicarbonate. Typical levels of abrasive polishing agents are from about 0% to about 65% by weight of the composition (Vermeer at column 17), which overlaps the instantly claimed range of 3 to 28%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches specific examples of alkyl ether sulfates useful in the present invention include sodium laureth-1 sulfate, sodium laureth-2 sulfate, sodium laureth-3 sulfate, (Vermeer at column 24) from about 0.02% to about 25% by weight of the composition is a cosuffactant (Vermeer at columns 42-35), which overlaps the instantly claimed range of 5 to 15%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches preservatives or antimicrobial agents that function as bactericides and/or fungicides useful in the present invention include glutaraldehyde, formaldehyde, paraformaldehyde, glyoxal, benzoic acid, sodium benzoate, potassium benzoate, sodium methyl p-hydroxybenzoate, salicylic acid, sorbic acid, dehydroacetic acid, benzyl alcohol, ethanol, 2-phenoxyethanol, chlorohexidine hydrochloride, dichlorophene (2,2'-dihydroxy-5,5'-dichlorodiphenyl methane)triclosan, chloroacetamide, p-chloro-m-xylenol, 1-(3-chloroallyl)-3,5,7-triaza-1-azoniaadamantane chloride, methyl paraben, propyl paraben, butyl paraben, benzyl paraben, imidazolidiyl urea, diazolidinyl urea, monomethylol dimethyl hydantoin (MDM hydantoin), dimethylol dimethyl hydantoin (DMDM hydantoin), iodopropylnyl butylcarbamate, 2-bromo-2-nitropropane-1,3-diol, 2-octyl-4-isothiazolin-3-one, 5-chloro-2-methyl-4-isothiazolin-3-one (methylchloroisothiazoline), 2-methyl-4-isothiazolin-3-one (methylisothaizoline) and dicocodimethylammonium chloride. Preferred preservatives are the alkyl parabens, benzoic acid and their salts. Typical levels of preservative used to control bacterial action are from about 0% to about 2% by weight of the composition (Vermeer at columns 41-42), which overlaps the instantly claimed range of 0.1 to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of essential flavorant oils useful in the present invention include oils of anise, irone, orris, caraway, clove, coriander, pimento, eucalyptus, eucalyptol, eugenol, nutmeg, thyme, peppermint, spearmint, wintergreen, cinnamon, cinnamon-mint, menthol, sassafras, anethole and mixtures thereof. Flavorant oils are added mainly to provide good flavor and favorable taste, however, some flavorant oils also provide antibacterial action. Preferred class of flavorant oil are peppermint, spearmint, wintergreen and mixtures thereof. Peppermint oil consists of a mixture of menthol, α-pinene, β-pinene, limonene, cineol, ethylamylcarbinol, methyl acetate, menthone, isomenthone, menthofuran, neomenthol, isomenthol and piperitone. Spearmint oil consists of a mixture of α-pinene, α-phellandr ene, limonene, octyl alcohol, dehydrocarveol, dipenlene cineol and carvene. Wintergreen oil consists mainly of methyl salicylate (wintergreen oil has been largely replaced with synthetic methyl salicylate). It should be noted that the specific choice of flavor is made on the basis that this class of flavor is highly desirable to the consuming public as representing and furnishing a fresh mouth feel as well as providing excellent persistent flavor notes effective for residual odor masking. The flavorant is characterized by containing major portions of menthol, carvene and methyl salicylate. Both natural and synthetic oils along with various flavor modifiers which give a distinctive note may be employed. Preferred flavor oils are peppermint, spearmint, wintergreen (as synthetic methyl salicylate) and mixtures thereof. Typical levels of flavorant oil are from about 0.01% to about 4% by weight of the composition (Vermeer at columns 36-37), which overlaps the instantly claimed range of 1 to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of colorants (dyes) useful in the present invention include D&C blue #1, D&C blue #4, D&C brown #1, D&C green #5 through #8, D&C orange #4 through #11, D&C yellow #2 through #11, D&C red #6 through #40, FD&C blue #1, FD&C blue #2, FD&C blue #4, FD&C red #3, FD&C red #4, FD&C red #33, FD&C red #40, FD&C yellow #5, FD&C yellow #6, FD&C yellow #10, FD&C orange #4, FD&C green #3, carmine and mixtures thereof. Preferred colorants are FD&C blue #1, FD&C green #3, FD&C yellow #10 and mixtures thereof. Typical levels of colorant are from about 0% to about 2% by weight of the composition (Vermeer at column 38), which overlaps the instantly claimed range of 0.1 to 10%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of pH-control agents useful in the present invention include citric acid, tartaric acid, lactic acid, gluconic acid, lactobionic acid, glycolic acid, propionic acid, succinic acid, hydrochloric acid, phosphoric acid, nitric acid, sulfuric acid, formic acid, boric acid, acetic acid, benzoic acid, palmitic acid, stearic acid, sodium hydroxide, sodium carbonate, sodium bicarbonate, potassium hydroxide, potassium carbonate, potassium bicarbonate and mixtures thereof. The amount of pH-control agent used will be that which is sufficient to provide the desired pH. The pH of the present compositions may be in the range of about 3 to about 9 preferably from about 4 to about 8. The amount of pH-adjusting agent used will be that which is sufficient to provide the desired pH, typically from about 0.01% to about 3% by weight of the composition (Vermeer at column 41), which overlaps the instantly claimed range of 0.5 to 40%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches abrasive polishing agents (body agents) useful in the dentifrice compositions of the present invention which function to remove debris and residual stains from the teeth as well as polish the tooth surface include calcium carbonate, precipitated calcium carbonate, light calcium carbonate, medium calcium carbonate, dense calcium carbonate, extra dense calcium carbonate, sodium carbonate, sodium bicarbonate (baking soda), potassium carbonate, potassium bicarbonate, anhydrous calcium phosphate, dicalcium phosphate, dibasic calcium phosphate dihydrate, tribasic calcium phosphate, sodium phosphate, potassium phosphate, calcium pyrophosphate, insoluble sodium metaphosphate, disodium orthophosphate, dibasic sodium phosphate, magnesium hydroxide, magnesium carbonate, magnesium silicate, magnesium trisilicate, trimagnesium phosphate, monomagnesium phosphate, magnesium oxide, stannic oxide, zinc oxide, chalk, extra light chalk, light chalk, medium chalk, course chalk, bentonite, flour of pumice, a-alumina trihydrate, levigated alumina, hydrated alumina, alumina aerogel, gelatinous alumina, aluminum silicate, calcined aluminum silicate, zirconium silicate, hydroxyapatite, crosslinked urea-formaldehyde resin, crosslinked melamine-formaldehyde resin, polymethacrylate, polymethylmethacrylate, polystyrene, powdered polyethylene, silica gel (hydrated silica), dehydrated silica gel (silica), silica precipitates, silica xerogel, silica hydrogels, silica pyrogel, silica aerogel and mixtures thereof. The average particle size of an abrasive polishing agent is from about 1 μm to about 20 μm, preferably from about 3 μm to about 12 μm. Preferred abrasive polishing agents include the silicas, sodium bicarbonate (baking soda), sodium carbonate, dicalcium phosphate, dibasic calcium phosphate dihydrate, tribasic calcium phosphate, sodium phosphate, calcium carbonate, α-alumina trihydrate and mixtures thereof. Most highly preferred abrasive polishing agents are hydrated silica and sodium bicarbonate. Typical levels of abrasive polishing agents are from about 0% to about 65% by weight of the composition (Vermeer at column 17), which overlaps the instantly claimed range of 0.001 to 10%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of amino acids useful in the present invention include alanine, β-alanine, N-methylalantne, N-phenylalanine, α-aminoisobutyric acid, α-aminobutyric acid, α-aminocaproic acid, α-aminocaproic acid, glycine, N-ethylglycine, N-propylglycine, N-butylglycine, leueine, methionine, sareosine, serine, norvaline, tryptophan, lysine, aspattic acid, glutamic add, iminodiaeetic add, keratin amino acids and mixtures thereof. The sodium, potassium, ammonium or calcium salts of amino adds are useful as well and may be preferred in certain instances. Typical levels of amino acid are from about 0% to about 5% by weight of the composition. (Vermeer at columns 39-40), which overlaps the instantly claimed range of 0 to 10%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches abrasive polishing agents (body agents) useful in the dentifrice compositions of the present invention which function to remove debris and residual stains from the teeth as well as polish the tooth surface include calcium carbonate, precipitated calcium carbonate, light calcium carbonate, medium calcium carbonate, dense calcium carbonate, extra dense calcium carbonate, sodium carbonate, sodium bicarbonate (baking soda), potassium carbonate, potassium bicarbonate, anhydrous calcium phosphate, dicalcium phosphate, dibasic calcium phosphate dihydrate, tribasic calcium phosphate, sodium phosphate, potassium phosphate, calcium pyrophosphate, insoluble sodium metaphosphate, disodium orthophosphate, dibasic sodium phosphate, and mixtures thereof. Typical levels of abrasive polishing agents are from about 0% to about 65% by weight of the composition (Vermeer at column 17), which overlaps the instantly claimed range of 0 to 40%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches further examples of addition non-astringent anti-plaque and/or anti-calculus agents include the soluble pyrophosphate salts such as sodium trihydrogen pyrophosphate, disodium dihydrogen pyrophosphate, trisodium hydrogen pyrophosphate, trisodium hydrogen pyrophosphate monohydrate, trisodium hydrogen pyrophosphate nonahydrate, tetrasodium pyrophosphate. tetrasodium pyrophosphate decahydrate, potassium trihydrogen pyrophosphate, dipotassium dihydrogen pyrophosphate, tripotassium hydrogen pyrophosphate, tetrapotassium pyrophosphate, diammonium dihydrogen pyrophosphate, triammonium hydrogen pyrophosphate, triammonium hydrogen pyrophosphate monohydrate, calcium dihydrogen pyrophosphate, calcium pyrophosphate, tetraaluminium pyrophosphate and mixtures thereof. These compounds are more fully disclosed in U.S. Pat. Nos. 4,515,772, 4,515,772 and 4,627,977 all of which are incorporated herein by reference. Preferred soluble pyrophosphate salts are sodium trihydrogen pyrophosphate, disodium dihydrogen pyrophosphate, tetrasodium pyrophosphate, tetrapotassium pyrophosphate and mixtures thereof. Typical levels of soluble pyrophosphate salt are from about 0% to about 8% by weight of the composition (Vermeer at column 35), which overlaps the instantly claimed range of 0.5 to 40%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 2,
Vermeer teaches examples of binders/cothickeners (stabilizing agents) useful in the dentifrice compositions of the present invention which provide gelatinous structure, paste firmness, mouth feel benefits and stabilize the toothpaste mass against liquid phase separation include carboxymethyl cellulose. Typical levels of binders/thickeners are from about 0% to about 30% by weight of a composition. (Vermeer at column 18), which overlaps the instantly claimed range of 0.7 to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches that the most highly preferred humectants are glycerin, sorbitol, hydrogenated starch hydrolyzates and mixtures thereof as described in U.S. Pat. No. 4,435,380 which is incorporated herein by reference. Typical levels of humectant are from about 0% to about 80% by weight of a composition. (Vermeer at columns 17-18), which overlaps the instantly claimed range of 45 to 55%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches fluorides useful in the present invention which serve to prevent dental caries include sodium fluoride. Most highly preferred fluorides are sodium fluoride, sodium monofluorophosphate arid mixtures thereof. Typical levels of fluoride are from about 0% to about 5% by weight of the composition. (Vermeer at column 37), which overlaps the instantly claimed range of 0 to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches sweeteners useful in the present invention which may be employed to round out the overall taste of the product include saccharin (as sodium, potassium or calcium saccharin), cyclamate (as sodium, potassium or calcium cyclamate), ASPARTAME®, acesulfane-K, thaumatin, neohisperidin dihydrochalcone, ammoniated glycyrrhizin, dextrose, levulose, sucrose, D-tryptophan, miraculin, NUTRASWEET, mannose, glucose, α-D-glucose, β-D-glucose, lactose, galactose and mixtures thereof. Both artificial and natural sweeteners may be used to add further sweetness than that provided by the essential flavoring oils. A preferred sweetener is the potassium or sodium salts of saccharin. Typical levels of sweetener are from about 0.01% to about 4% by weight of the composition (Vermeer at column 37), which overlaps the instantly claimed range of 0.5 to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches preservatives or antimicrobial agents that function as bactericides and/or fungicides useful in the present invention include benzoic acid, sodium benzoate, potassium benzoate, sodium methyl p-hydroxybenzoate, benzyl alcohol, ethanol, 2-phenoxyethanol, chlorohexidine methyl paraben, propyl paraben, butyl paraben, benzyl paraben, imidazolidiyl urea, diazolidinyl urea, monomethylol dimethyl hydantoin (MDM hydantoin), dimethylol dimethyl hydantoin (DMDM hydantoin), and dicocodimethylammonium chloride. Preferred preservatives are the alkyl parabens, benzoic acid and their salts. Typical levels of preservative used to control bacterial action are from about 0% to about 2% by weight of the composition (Vermeer at columns 41-42), which overlaps the instantly claimed range of 0.1 to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of humectants useful in the present invention which serve to add body or mouth feel to a mouthwash or dental rinse composition and retain moisture in a dentifrice composition include polyethylene polyethylene glycol-400 (PEG-8), polyethylene glycol-450 (PEG-9), polyethylene glycol-500 (PEG-10), polyethylene glycol-600 (PEG-12), propylene glycol (PG), glycerol (glycerin), erythritol, xylitol, sorbitol, mannitol, lactitol, hydrogenated starch hydrolyzates and mixtures thereof. In addition, humectants help prevent microbial deterioration during storage of oral hygiene composition, assist in maintaining phase stability and provide a means to formulate a transparent or translucent dentifrice. Typical levels of humectant are from about 0% to about 80% by weight of a composition. (Vermeer at columns 17-18), which overlaps the instantly claimed range of 0.1 to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches further examples of addition non-astringent anti-plaque and/or anti-calculus agents include the soluble pyrophosphate salts. Preferred soluble pyrophosphate salts are sodium trihydrogen pyrophosphate, disodium dihydrogen pyrophosphate, tetrasodium pyrophosphate, tetrapotassium pyrophosphate and mixtures thereof. Typical levels of soluble pyrophosphate salt are from about 0% to about 8% by weight of the composition (Vermeer at column 35), which overlaps the instantly claimed range of 0.5 to 40%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of humectants useful in the present invention which serve to add body or mouth feel to a mouthwash or dental rinse composition and retain moisture in a dentifrice composition include polyethylene polyethylene glycol-400 (PEG-8), polyethylene glycol-450 (PEG-9), polyethylene glycol-500 (PEG-10), polyethylene glycol-600 (PEG-12), propylene glycol (PG), glycerol (glycerin), erythritol, xylitol, sorbitol, mannitol, lactitol, hydrogenated starch hydrolyzates and mixtures thereof. Typical levels of humectant are from about 0% to about 80% by weight of a composition. (Vermeer at columns 17-18), which overlaps the instantly claimed range of 40 to 70%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of humectants useful in the present invention which serve to add body or mouth feel to a mouthwash or dental rinse composition and retain moisture in a dentifrice composition include polyethylene polyethylene glycol-400 (PEG-8), polyethylene glycol-450 (PEG-9), polyethylene glycol-500 (PEG-10), polyethylene glycol-600 (PEG-12), propylene glycol (PG), glycerol (glycerin), erythritol, xylitol, sorbitol, mannitol, lactitol, hydrogenated starch hydrolyzates and mixtures thereof. Typical levels of humectant are from about 0% to about 80% by weight of a composition. (Vermeer at columns 17-18), which overlaps the instantly claimed range of 40 to 70%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of binders/cothickeners (stabilizing agents) useful in the dentifrice compositions of the present invention which provide gelatinous structure, paste firmness, mouth feel benefits and stabilize the toothpaste mass against liquid phase separation include carboxymethyl cellulose, silicate clays, silica precipitates, silica aerogels, pyrogenic silicas, colloidal magnesium aluminum silicate and mixtures thereof. Typical levels of binders/thickeners are from about 0% to about 30% by weight of a composition. (Vermeer at column 18), which overlaps the instantly claimed range of 7 to 15%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches the use of silica gel (hydrated silica), dehydrated silica gel (silica), silica precipitates, silica xerogel, silica hydrogels, silica pyrogel, silica aerogel and mixtures thereof. Vermeer teaches that typical levels of abrasive polishing agents are from about 0% to about 65% by weight of the composition (Vermeer at column 17), which overlaps the instantly claimed range of 7 to 15%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches specific examples of alkyl ether sulfates useful in the present invention include sodium laureth-1 sulfate, sodium laureth-2 sulfate, sodium laureth-3 sulfate, (Vermeer at column 24) from about 0.02% to about 25% by weight of the composition is a cosuffactant (Vermeer at columns 42-35), which overlaps the instantly claimed range of 5 to 15%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches preservatives or antimicrobial agents that function as bactericides and/or fungicides useful in the present invention include dichlorophene (2,2'-dihydroxy-5,5'-dichlorodiphenyl methane)triclosan . Preferred preservatives are the alkyl parabens, benzoic acid and their salts. Typical levels of preservative used to control bacterial action are from about 0% to about 2% by weight of the composition (Vermeer at columns 41-42), which overlaps the instantly claimed range of 0.1 to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of essential flavorant oils useful in the present invention include oils of anise, irone, orris, caraway, clove, coriander, pimento, eucalyptus, eucalyptol, eugenol, nutmeg, thyme, peppermint, spearmint, wintergreen, cinnamon, cinnamon-mint, menthol, sassafras, anethole and mixtures thereof. Flavorant oils are added mainly to provide good flavor and favorable taste, however, some flavorant oils also provide antibacterial action. Preferred class of flavorant oil are peppermint, spearmint, wintergreen and mixtures thereof. Peppermint oil consists of a mixture of menthol, α-pinene, β-pinene, limonene, cineol, ethylamylcarbinol, methyl acetate, menthone, isomenthone, menthofuran, neomenthol, isomenthol and piperitone. Spearmint oil consists of a mixture of α-pinene, α-phellandr ene, limonene, octyl alcohol, dehydrocarveol, dipenlene cineol and carvene. Wintergreen oil consists mainly of methyl salicylate (wintergreen oil has been largely replaced with synthetic methyl salicylate). Typical levels of flavorant oil are from about 0.01% to about 4% by weight of the composition (Vermeer at columns 36-37), which overlaps the instantly claimed range of 1 to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 3,
Vermeer teaches examples of binders/cothickeners (stabilizing agents) useful in the dentifrice compositions of the present invention which provide gelatinous structure, paste firmness, mouth feel benefits and stabilize the toothpaste mass against liquid phase separation include carboxymethyl cellulose. Typical levels of binders/thickeners are from about 0% to about 30% by weight of a composition. (Vermeer at column 18), which overlaps the instantly claimed range of 0.7 to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches that the most highly preferred humectants are glycerin, sorbitol, hydrogenated starch hydrolyzates and mixtures thereof as described in U.S. Pat. No. 4,435,380 which is incorporated herein by reference. Typical levels of humectant are from about 0% to about 80% by weight of a composition. (Vermeer at columns 17-18), which overlaps the instantly claimed range of 45 to 55%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches sweeteners useful in the present invention which may be employed to round out the overall taste of the product include saccharin (as sodium, potassium or calcium saccharin), cyclamate (as sodium, potassium or calcium cyclamate), ASPARTAME®, acesulfane-K, thaumatin, neohisperidin dihydrochalcone, ammoniated glycyrrhizin, dextrose, levulose, sucrose, D-tryptophan, miraculin, NUTRASWEET, mannose, glucose, α-D-glucose, β-D-glucose, lactose, galactose and mixtures thereof. Both artificial and natural sweeteners may be used to add further sweetness than that provided by the essential flavoring oils. A preferred sweetener is the potassium or sodium salts of saccharin. Typical levels of sweetener are from about 0.01% to about 4% by weight of the composition (Vermeer at column 37), which overlaps the instantly claimed range of 0.5 to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches preservatives or antimicrobial agents that function as bactericides and/or fungicides useful in the present invention include benzoic acid, sodium benzoate, potassium benzoate, sodium methyl p-hydroxybenzoate, benzyl alcohol, ethanol, 2-phenoxyethanol, chlorohexidine methyl paraben, propyl paraben, butyl paraben, benzyl paraben, imidazolidiyl urea, diazolidinyl urea, monomethylol dimethyl hydantoin (MDM hydantoin), dimethylol dimethyl hydantoin (DMDM hydantoin), and dicocodimethylammonium chloride. Preferred preservatives are the alkyl parabens, benzoic acid and their salts. Typical levels of preservative used to control bacterial action are from about 0% to about 2% by weight of the composition (Vermeer at columns 41-42), which overlaps the instantly claimed range of 0.1 to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of humectants useful in the present invention which serve to add body or mouth feel to a mouthwash or dental rinse composition and retain moisture in a dentifrice composition include polyethylene polyethylene glycol-400 (PEG-8), polyethylene glycol-450 (PEG-9), polyethylene glycol-500 (PEG-10), polyethylene glycol-600 (PEG-12), propylene glycol (PG), glycerol (glycerin), erythritol, xylitol, sorbitol, mannitol, lactitol, hydrogenated starch hydrolyzates and mixtures thereof. In addition, humectants help prevent microbial deterioration during storage of oral hygiene composition, assist in maintaining phase stability and provide a means to formulate a transparent or translucent dentifrice. Typical levels of humectant are from about 0% to about 80% by weight of a composition. (Vermeer at columns 17-18), which overlaps the instantly claimed range of 0.1 to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of pH-control agents useful in the present invention include citric acid, tartaric acid, lactic acid, gluconic acid, lactobionic acid, glycolic acid, propionic acid, succinic acid, hydrochloric acid, phosphoric acid, nitric acid, sulfuric acid, formic acid, boric acid, acetic acid, benzoic acid, palmitic acid, stearic acid, sodium hydroxide, sodium carbonate, sodium bicarbonate, potassium hydroxide, potassium carbonate, potassium bicarbonate and mixtures thereof. The amount of pH-control agent used will be that which is sufficient to provide the desired pH. The pH of the present compositions may be in the range of about 3 to about 9 preferably from about 4 to about 8. The amount of pH-adjusting agent used will be that which is sufficient to provide the desired pH, typically from about 0.01% to about 3% by weight of the composition (Vermeer at column 41), which overlaps the instantly claimed range of 2 to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches that the most highly preferred humectants are glycerin, sorbitol, hydrogenated starch hydrolyzates and mixtures thereof as described in U.S. Pat. No. 4,435,380 which is incorporated herein by reference. Typical levels of humectant are from about 0% to about 80% by weight of a composition. (Vermeer at columns 17-18), which overlaps the instantly claimed range of 40 to 70%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of humectants useful in the present invention which serve to add body or mouth feel to a mouthwash or dental rinse composition and retain moisture in a dentifrice composition include polyethylene polyethylene glycol-400 (PEG-8), polyethylene glycol-450 (PEG-9), polyethylene glycol-500 (PEG-10), polyethylene glycol-600 (PEG-12), propylene glycol (PG), glycerol (glycerin), erythritol, xylitol, sorbitol, mannitol, lactitol, hydrogenated starch hydrolyzates and mixtures thereof. Typical levels of humectant are from about 0% to about 80% by weight of a composition. (Vermeer at columns 17-18), which overlaps the instantly claimed range of 40 to 70%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches the use of silica gel (hydrated silica), dehydrated silica gel (silica), silica precipitates, silica xerogel, silica hydrogels, silica pyrogel, silica aerogel and mixtures thereof. Vermeer teaches that typical levels of abrasive polishing agents are from about 0% to about 65% by weight of the composition (Vermeer at column 17), which overlaps the instantly claimed range of 7 to 15%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches abrasive polishing agents (body agents) useful in the dentifrice compositions of the present invention which function to remove debris and residual stains from the teeth as well as polish the tooth surface include calcium carbonate, precipitated calcium carbonate, light calcium carbonate, medium calcium carbonate, dense calcium carbonate, extra dense calcium carbonate, sodium carbonate, sodium bicarbonate (baking soda), potassium carbonate, potassium bicarbonate, anhydrous calcium phosphate, dicalcium phosphate, dibasic calcium phosphate dihydrate, tribasic calcium phosphate, sodium phosphate, potassium phosphate, calcium pyrophosphate, insoluble sodium metaphosphate, disodium orthophosphate, dibasic sodium phosphate, and mixtures thereof. Vermeer teaches that the average particle size of an abrasive polishing agent is from about 1 μm to about 20 μm, preferably from about 3 μm to about 12 μm, which would be microlyzed and could be represented in a nanometer scale. Vermeer does not require the composition to be at a specific scale. Typical levels of abrasive polishing agents are from about 0% to about 65% by weight of the composition (Vermeer at column 17), which overlaps the instantly claimed range of 0.5 to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches specific examples of alkyl ether sulfates useful in the present invention include sodium laureth-1 sulfate, sodium laureth-2 sulfate, sodium laureth-3 sulfate, (Vermeer at column 24) from about 0.02% to about 25% by weight of the composition is a cosuffactant (Vermeer at columns 42-35), which overlaps the instantly claimed range of 5 to 15%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches preservatives or antimicrobial agents that function as bactericides and/or fungicides useful in the present invention include dichlorophene (2,2'-dihydroxy-5,5'-dichlorodiphenyl methane)triclosan . Preferred preservatives are the alkyl parabens, benzoic acid and their salts. Typical levels of preservative used to control bacterial action are from about 0% to about 2% by weight of the composition (Vermeer at columns 41-42), which overlaps the instantly claimed range of 0.1 to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of essential flavorant oils useful in the present invention include oils of anise, irone, orris, caraway, clove, coriander, pimento, eucalyptus, eucalyptol, eugenol, nutmeg, thyme, peppermint, spearmint, wintergreen, cinnamon, cinnamon-mint, menthol, sassafras, anethole and mixtures thereof. Flavorant oils are added mainly to provide good flavor and favorable taste, however, some flavorant oils also provide antibacterial action. Preferred class of flavorant oil are peppermint, spearmint, wintergreen and mixtures thereof. Peppermint oil consists of a mixture of menthol, α-pinene, β-pinene, limonene, cineol, ethylamylcarbinol, methyl acetate, menthone, isomenthone, menthofuran, neomenthol, isomenthol and piperitone. Spearmint oil consists of a mixture of α-pinene, α-phellandr ene, limonene, octyl alcohol, dehydrocarveol, dipenlene cineol and carvene. Wintergreen oil consists mainly of methyl salicylate (wintergreen oil has been largely replaced with synthetic methyl salicylate). Typical levels of flavorant oil are from about 0.01% to about 4% by weight of the composition (Vermeer at columns 36-37), which overlaps the instantly claimed range of 0.5 to 3%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of pH-control agents useful in the present invention include citric acid, tartaric acid, lactic acid, gluconic acid, lactobionic acid, glycolic acid, propionic acid, succinic acid, hydrochloric acid, phosphoric acid, nitric acid, sulfuric acid, formic acid, boric acid, acetic acid, benzoic acid, palmitic acid, stearic acid, sodium hydroxide, sodium carbonate, sodium bicarbonate, potassium hydroxide, potassium carbonate, potassium bicarbonate and mixtures thereof. The amount of pH-control agent used will be that which is sufficient to provide the desired pH. The pH of the present compositions may be in the range of about 3 to about 9 preferably from about 4 to about 8. The amount of pH-adjusting agent used will be that which is sufficient to provide the desired pH, typically from about 0.01% to about 3% by weight of the composition (Vermeer at column 41), which overlaps the instantly claimed range of 2 to 5%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 4,
Vermeer teaches examples of binders/cothickeners (stabilizing agents) useful in the dentifrice compositions of the present invention which provide gelatinous structure, paste firmness, mouth feel benefits and stabilize the toothpaste mass against liquid phase separation include carboxymethyl cellulose. Typical levels of binders/thickeners are from about 0% to about 30% by weight of a composition. (Vermeer at column 18), which overlaps the instantly claimed range of 0.7 to 1%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches that the most highly preferred humectants are glycerin, sorbitol, hydrogenated starch hydrolyzates and mixtures thereof as described in U.S. Pat. No. 4,435,380 which is incorporated herein by reference. Typical levels of humectant are from about 0% to about 80% by weight of a composition. (Vermeer at columns 17-18), which overlaps the instantly claimed range of 45 to 55%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches the use of silica gel (hydrated silica), dehydrated silica gel (silica), silica precipitates, silica xerogel, silica hydrogels, silica pyrogel, silica aerogel and mixtures thereof. Vermeer teaches that typical levels of abrasive polishing agents are from about 0% to about 65% by weight of the composition (Vermeer at column 17), which overlaps the instantly claimed range of 5 to 25%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of colorants (dyes) useful in the present invention include D&C blue #1, D&C blue #4, FD&C blue #1, FD&C blue #2, FD&C blue #4, and mixtures thereof. Preferred colorants are FD&C blue #1, FD&C green #3, FD&C yellow #10 and mixtures thereof. Typical levels of colorant are from about 0% to about 2% by weight of the composition (Vermeer at column 38), which overlaps the instantly claimed range of 0.1 to 0.3%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Vermeer teaches examples of pH-control agents useful in the present invention include citric acid, tartaric acid, lactic acid, gluconic acid, lactobionic acid, glycolic acid, propionic acid, succinic acid, hydrochloric acid, phosphoric acid, nitric acid, sulfuric acid, formic acid, boric acid, acetic acid, benzoic acid, palmitic acid, stearic acid, sodium hydroxide, sodium carbonate, sodium bicarbonate, potassium hydroxide, potassium carbonate, potassium bicarbonate and mixtures thereof. The amount of pH-control agent used will be that which is sufficient to provide the desired pH. The pH of the present compositions may be in the range of about 3 to about 9 preferably from about 4 to about 8. The amount of pH-adjusting agent used will be that which is sufficient to provide the desired pH, typically from about 0.01% to about 3% by weight of the composition (Vermeer at column 41), and Vermeer further teaches phosphoric acids as chelating or sequestering agents yypical levels of chelating or sequestering agent useful for complexing hard ions such as calcium and magnesium are from about 0% to about 6% by weight of the composition, which overlaps the instantly claimed range of 5 to 40%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 5, compositions with the amounts taught in above in claims 1-4 would fall within the range taught by instant claim 5. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 6, Vermeer teaches that the pH of the present compositions may be in the range of about 3 to about 9 (Vermeer at column 41), which overlaps the instantly claimed range of 2 to 5.5. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 7, Vermeer teaches that the average particle size of an abrasive polishing agent is from about 1 μm to about 20 μm, preferably from about 3 μm to about 12 μm, which would be microlyzed and could be represented in a nanometer scale. Vermeer does not require the composition to be at a specific scale.
Regarding instant claim 8, recites to the best of the Examiner’s understanding an intended use of the composition after application to the oral cavity.
Regarding instant claim 9, recites to the best of the Examiner’s understanding an intended use of the composition after application to the oral cavity.
Regarding instant claim 10, recites to the best of the Examiner’s understanding an intended use of the composition with application to the oral cavity.
Regarding instant claim 11, Vermeer teaches the use of calcium carbonate as an abrasive. Typical levels of abrasive polishing agents are from about 0% to about 65% by weight of the composition (Vermeer at column 17), which overlaps the instantly claimed range of 0.001 to 10%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP§2144.05(I).
Regarding instant claim 12, magnesium silicate, magnesium trisilicate, aluminum silicate, calcined aluminum silicate, zirconium silicate, hydroxyapatite, crosslinked urea-formaldehyde resin, crosslinked melamine-formaldehyde resin, polymethacrylate, polymethylmethacrylate, polystyrene, powdered polyethylene, silica gel (hydrated silica), dehydrated silica gel (silica), silica precipitates, silica xerogel, silica hydrogels, silica hydrogel, silica aerogel and mixtures thereof. (Vermeer at column 17).
Regarding instant claims 13-14, Vermeer teaches that oral hygiene compositions are available in a variety of types and forms. A classification according to product type includes, but is not limited to mouthwashes, pre-brushing dental rinses, post-brushing dental rinses, dental sprays, dental creams, toothpastes, toothpaste gels, toothpowders, dental cleansers, dental flosses, chewing gums, lozenges and the like. Preferred are the mouthwashes, pre-brushing dental rinses, post-brushing dental rinses, toothpastes and toothpaste gels. A classification according to product form would consist of aerosol, liquid, gel, cream, paste, granular, tablet or powdered form. Preferred product form for mouthwashes, pre-brushing dental rinses and postbrushing dental rinses of the invention is liquid form. Preferred product form for denaces (toothpastes) of the invention is gel or paste form (Vermeer at column 46).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11-20 of copending Application No. 17/419,198 (reference application) in view of Vermeer (US Patent 5,624,906A). The instant claim recites “An oral composition with synergistic association of organic and inorganic components, wherein it features in its constitution, spread into three phases (phase 1, phase 2 and phase 3) and with the possibility of combination into variations (variation 1) the following components:
a) Moistener: at a 40 to 70% m/m proportion of the composition; selected among PEG 600, PEG 400, glycerin, sorbitol, in isolation or combined;
b) Thickener: at a 5 to 30% m/m proportion of the composition; selected among carboxymethylcellulose, xanthan gum, thickening silica, in isolation or combined;
c) Deionized water: at a 0.1 to 7% m/m proportion of the composition;
d) Fluorides: at a 0 to 1%m/m proportion of the composition; selected among:stannous fluoride, sodium fluoride, potassium fluoride, sodium monofluorophosphate, sodium fluorosilicate, ammonium fluorosilicate, amine fluoride (for example, N'-octadecyltrimethylendiamine-N, N, N'-tris (2-ethanol)- dihydrofluoride), ammonium fluoride, titanium fluoride, hexafluorosulfate and combinations thereof;
e) Sweeteners: at a 0.5 to 5%m/m proportion of the composition; selected between sodium saccharine and xylitol;
f) Preservative: at a 0.1 to 1%m/m proportion; selected among sodium Benzoate, methylparabens, parabens; preferably sodium Benzoate;
g) Remineralizing salts, desensitizers and catalysts: at a 0.1 to 10%m/m proportion of the composition; selected among sidium, calcium, potassium, iron, zinc, tin,magnesium, titanium, aluminum and/or copper ions.
h) Abrasive: at a 3 to 18%m/m proportion of the composition; selected between calcium carbonate, sodium, silica;
i) Surfactant: at a 5 to 15%m/m proportion of the composition; selected among sodium laureth sulfate, sodium alkyl sulfate, sodium lauroyl sarcosinate, cocamidopropyl betaine and polysorbate and combinations thereof; preferably,sodium laureth sulfate;
j) Antiseptic: at a 0.1 to 1%m/m proportion of the composition; selected among halogenated diphenyl ether, triclosan, herb extracts, essential oils, rosemary extract, tea extract, magnolia extract, thymol, menthol, eucalyptol, geraniol, carvacrol, citral, hinokitol, catechol, methyl salicylate, epigallocatechm gallate, epigallocatechm, gallic acid, miswak, sea-buckthom extract, biguanide antiseptics, chlorhexidine, alexidine or octenidine, quaternary ammonium composites, cetylpyridinium chloride (CPC), benzalkonium chloride, tetradecyl pyridinium chloride (TPC), N-tetradecyl-4-ethylpyridinol chloride, N-tetradecyl- 4-ethylpyridinol chloride, octenidine, sanguinarine, Povidone-iodine, delmopinol, salifluorine, tin salts, copper salts, iron salts, sanguinarine, propolis and oxigenating agents, hydrogen peroxide, buffered sodium peroxoborate or peroxocarbonate, phthalic acid and its salts, monopertallic acids and its salts and esters, ascorbyl stearate, oleoylsarcosine, alkyl sulfate, dioctyl sulfossuccinate sulfate, salicylanilide, domiphen bromide, delmopinol, octapinol and other piperidine byproducts, nicin preparations, chlorite salts or any mixtures between any aforementioned substances; preferably, triclosan;
k) Flavoring agent: at a 1 to 5% m/m proportion of the composition, selected among essential oils (mint, peppermint, spearmint, lemon grass, clove, salvia, strawberry, grape, eucalyptus, marjoram, cinnamon, lemon, rosemary-pepper,orange), as well as aldehydes, esters, alcohols and similar flavoring materials;
l) Pigments/dyes: at a 0.1 to 10%m/m proportion of the composition; may be organic or inorganic, selected among peroxides, superoxides, oxygen forming agents and ingredients for optical bleaching as all dyes and pigments, organic and inorganic, which act within the blue to violet light spectrum to reflect white light, such as mica and silicon compounds;
m) pH corrector: at a 0.5 to 40% m/m proportion of the composition; selected among basics (mono- and di-sodium phosphates) and acids (phosphoric, citric, maleic);
n) Calcium sources: at a 0.001 to 10%m/m proportion of the composition; selected among: calcium glycerophosphate, calcium carbonate and tricalcium phosphate, from organic sources or not;
o) Amino acids: at a 0 a 10%m/m proportion of the composition; selected among arginine, lysine, citrulline, ornithine, creatine, histidine, diaminobutanoic acid, diaminopropionic acid, salts and/or combinations thereof, or even any aminoacids with a carboxyl group and a water soluble amino group and available in aqueous solution with a pH around 7 or lower, preferably arginine;
p) Orthophosphoric acid: at a 0 to 40% mm proportion of the composition;
q) Tetrasodium pyrophosphate, at a 0.5 to 40%m/m proportion of the formulation.”.
The reference application recites a multipurpose fluorinated biphosphate toothpaste composition for application as anti-demineralizing, regenerative and dental desensitizer, the composition comprising: sodium fluoride, in a proportion from 0.25% to 0.5% mass/mass of the composition, wherein the sodium fluoride is an anti-carie agent; tetrasodium pyrophosphate, in a proportion from 0.3% to 1.0% mass/mass of the composition, wherein the tetrasodium pyrophosphate is an anti-tartar agent; orthophosphoric acid, in a proportion from 0.8% to 2.0% mass/mass of the composition, wherein the orthophosphoric acid is a pH regulator, wherein the biphosphate toothpaste composition pH is 4.3 to 5.3, wherein the orthophosphoric acid and the tetrasodium pyrophosphate make phosphate available in an acid medium in the presence of saliva in the oral cavity for precipitation of calcium fluoride for remineralization and dentinal desensitization; triclosan, in a proportion from 0.1% to 0.3% mass/mass of the composition, wherein the triclosan is an antiseptic agent; and deionized water, in a proportion from 2% to 4.9% mass/mass of the composition (‘198 at claim 1). The reference application recites further comprising: humectant, in a proportion from 50% to 60% mass/mass of the composition, wherein the humectant further comprises glycerin, sorbitol and polyethylene glycol; and a thickener, in a proportion from 8% to 12% mass/mass of the composition, wherein the thickener further comprises carboxymethylcellulose and thickener silica (‘198 at claim 2). The reference application recites wherein the fluorinated biphosphate toothpaste when used forms a slurry in the mouth and after one minute's brushing maintains an acid pH range from 4.5 and 5.0 (‘198 at claim 3). The reference application recites further comprising: fluorapatite, wherein the fluorapatite is a remineralizing agent (‘198 at claim 4). The reference application recites wherein the fluorapatite further comprises: calcium salts, in a proportion from 0.5% to 6% mass/mass of the composition, wherein the calcium salts comprise at least one of a group of calcium glycerophosphate, calcium carbonate or calcium hydroxide (‘198 at claim 5). The reference application recites further comprising: a sweetener, in a proportion from 0.5 to 1.5% mass/mass of the composition, wherein the sweetener comprises sodium saccharin and xylitol; a preservative in a proportion from 0.1 to 0.5% mass/mass of the composition, wherein the preservative comprises sodium benzoate; an abrasive, in a proportion from 5 to 15% mass/mass of the composition, wherein the abrasive comprises abrasive silica; a surfactant, in a proportion from 5 to 10% mass/mass of the composition, wherein the surfactant comprises sodium lauryl sulfate; at least one flavoring, in a proportion from 1 to 3% mass/mass of the composition; and at least one pigment in a proportion from 0.1 to 0.2% mass/mass of the composition, wherein the at least one pigment comprises mica (‘198 at claim 6). The reference application recites wherein the orthophosphoric acid forms hydronium after contacting water (‘198 at claim 7). The reference application recites a fluorinated biphosphate toothpaste, the fluorinated biphosphate toothpaste comprising: water in a proportion from 2% to 4.9% mass/mass of the composition; a sodium fluoride anti-carie agent in a proportion from 0.25% to 0.5% mass/mass of the composition, wherein the fluoride anti-carie agent, upon use, and occludes dentinal tubules; and a plurality of phosphate compounds, wherein a first phosphate compound of the plurality of phosphate compounds regulates an acid pH of the fluorinated biphosphate toothpaste; wherein the first of the plurality of phosphate compounds together with a second plurality of phosphate compounds, tetrasodium pyrophosphate, renders phosphate available in an acid medium; wherein the plurality of phosphate compounds, in the presence of saliva in the acid pH, precipitates calcium fluoride to regenerate teeth minerals; wherein the plurality of phosphate compounds prevent demineralizing of the teeth minerals; and wherein the fluoride anti-carie agent desensitizes teeth (‘198 at claim 8). The reference application recites wherein the fluoride anti-carie agent precipitates calcium fluoride upon contact with saliva (‘198 at claim 9). The reference application recites wherein the pH ranges from 4.3 and 5.3 (‘198 at claim 11). The reference application recites wherein the plurality of phosphate compounds further comprise a second phosphate compound acting as an anti-tartar agent, a remineralizer and a desensitizer (‘198 at claim 12). The reference application recites a method for producing a multipurpose fluorinated biphosphate toothpaste, the method comprising: mixing at least one anticaries agent, at least one sweetener, at least one preservative, and at least one phosphate anti-tartar agent to form a dentifrice composition; correcting the pH of the dentifrice composition, wherein the pH is corrected by mixing a pH regulator with the first composition to form the multipurpose fluorinated biphosphate toothpaste (‘198 at claim 13). The reference application recites (‘198 at claim 14). The reference application recites further comprising: applying orally the multipurpose fluorinated biphosphate toothpaste to one or more teeth to anti-demineralizing, remineralize and desensitize the one or more teeth (‘198 at claim 15). The reference application recites (‘198 at claim 16). The reference application recites wherein the mixing step comprises mixing using a turbine, scraper and propeller (‘198 at claim 17). The reference application recites further comprising: mixing a first humectant with a thickener to form a premixture; mixing a second humectant, a third humectant, and the premixture with the dentifrice composition; adding a thickener silica and an abrasive silica to the dentifrice composition; mixing a surfactant with the dentifrice composition; adding an antiseptic, at least one flavoring, and at least one pigment to the dentifrice composition (‘198 at claim 18). The reference application recites wherein the anti-tartar agent comprises tetrasodium pyrophosphate (‘198 at claim 19).
The teachings of Vermeer are discussed above.
It would have been prima facie obvious to one of ordinary skill in the art to have included the flavorings of Vermeer as the flavor of the oral care composition of application ‘198 as ‘198 teachings the use of flavorings but does not specific what flavors are used. See MPEP 2144.07. One would have a reasonable expectation of success because the flavorants are used for their intended purpose and both compositions teach oral care compositions comprising sodium fluoride, tetrasodium pyrophosphate, triclosan, deionized water, glycerin, sorbitol, polyethylene glycol, carboxymethylcellulose, thickener silica, calcium salts, calcium carbonate, sodium saccharin and xylitol, sodium benzoate, abrasive silica, sodium lauryl sulfate, flavoring, pigment, and orthophosphoric acid.
Reference claims and prior art combine to produce a prima facie case of obviousness type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are presently allowable.
Correspondence
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/AMANDA MICHELLE PETRITSCH/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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