DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a national stage entry of PCT/DE2022/100316 filed on 04/28/2022. Acknowledgment is made of applicant's claim for foreign priority based on an application filed in GERMANY on 05/03/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112(b)
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 2-5, 7, 9, and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation "wherein the pH regulator (d)" in line 2. There is insufficient antecedent basis for this limitation in the claim since claim 6 from which claim 7 depends claims (c) the one or more pH regulators and (d) one or more pharmaceutical or cosmetic ingredients. Examiner suggests replacing "wherein the pH regulator (d)" in line 2 with “wherein the one or more pH regulators (c)…”.
Claim 8 recites “the pharmaceutical or cosmetic ingredient(d)”, which lacks proper antecedent basis. Claim 6. from which claim 8 depends, recites “one or more pharmaceutical or cosmetic ingredients”. Since it is unclear which of the possible plurality of ingredients is being referred to in claim 8, Examiner suggests amending “the pharmaceutical or cosmetic ingredient(d)” to “the one or more pharmaceutical or cosmetic ingredients (d)…”.
Claim 12 recites the limitation "the dwell time" in line 2. There is insufficient antecedent basis for this limitation in the claim since claim 11 from which claim 12 depends does not recite any dwell time.
Regarding claim 3, 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).
Regarding claims 2, 4 and 12 the word "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(d).
Regarding claims 2 and 5, the phrase "particularly 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(d).
Regarding claim 2, the phrase "in particular" 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 9, the phrase "more 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(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 2 recites the broad recitation an amount of from 0.0001 to 0.25% by weight, and the claim also recites from 0.001 to 0.1% by weight; from 0.01 to 0.05% by weight, and 0.025% by weight, which is the narrower statement of the range/limitation.
Claim 3 recites the broad recitation cellulose and cellulose derivatives, and the claim also recites methyl cellulose, ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, hydroxypropyl methyl cellulose, carboxymethyl cellulose, sodium carboxymethyl cellulose, agaraose, agar, pectins, sclerotium gum, xanthan gum, guar gum, carrageenan, alginic acid, polyvinyl alcohol, polyvinyl pyrrolidone and mixtures thereof, which is the narrower statement of the range/limitation.
Claim 4 recites the broad recitation a natural raw material, and the claim also recites celluloses and xanthans which is the narrower statement of the range/limitation.
Claim 5 recites the broad recitation an amount of from 0.01 to 4.0% by weight, and the claim also recites from 1.5 to 3.0% by weight and approximately 2.0% by weight which is the narrower statement of the range/limitation.
Claim 9 recites the broad recitation a pH value in the range from 5.5 to 8.5, and the claim also recites a pH value in the range from 7.0 to 8.0, and approximately 7.5 which is the narrower statement of the range/limitation.
Claim 12 recites the broad recitation between 3 minutes and 72 hours, and the claim also recites between 5 minutes and 48 hours, and 10 minutes and 24 hours which is the narrower statement of the range/limitation.
The claims 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.
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 1-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18/288,082 (U.S. Publication No. 2024/0207157 A1) in view of TAKAHASHI HIROKAZU et al. JP-8-245350 A (see machine English translation provided).
Claims 1-10 of the instant application claim an oral gel composition to be applied to the gums and to remain thereon for at least 3 minutes, comprising (a) at least 0.00001 and less than 0.5% by weight caffeine and (b) a gelling agent.
With respect to the limitation of “an oral gel” it is noted that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPTQ2d 1161, 1165 (Fed. Cir. 1999). In the instant case, a prior art which discloses a composition comprising the same components as claimed, i.e. caffeine and a gelling agent, said composition will be considered an oral gel composition as claimed.
With regard to the limitation of “to be applied to the gums and to remain thereon for at least 3 minutes”, this limitation is interpreted as an intended use of the claimed composition. It is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). In the instant case, a prior art which discloses a composition comprising the same components as claimed will necessarily be capable of performing the claimed intended use and being applied to the gums to remain thereon for at least 3 minutes.
Claims 1-11 of copending ‘082 claim an oral care agent, in particular toothpaste or mouthwash, wherein the oral care agent contains caffeine and a calcium phosphate compound, preferably in particulate form, selected from the group consisting of monocalcium phosphate monohydrate (MCPM), anhydrous monocalcium phosphate (AMCP), octacalcium phosphate (OCP), amorphous calcium phosphate (ACP), calcium-deficient hydroxyapatite (CDHA), hydroxyapatite (HA or HAP) and tetracalcium phosphate (TTCP), particularly preferably hydroxyapatite, wherein the oral care agent contains caffeine in an amount of from 0.00001 to 4.0% by weight, preferably from 0.0001 to 1.0% by weight and particularly preferably from 0.0005 to 0.1% by weight, each in relation to the total weight of the oral care agent.
Copending ‘082 does not claim the composition comprises a gelling agent.
Takahashi et al. teaches a composition for oral cavities containing a sweet taste-having base agent (e.g. sorbitol) and at least one specific bitter component (b) selected from 8-acetyl sucrose, quinine hydrochloride, quinine sulfate, caffeine and brucine wherein the bitter taste component in the oral cavity composition is contained in an amount of 1×10-6 -1 wt.% (overview and claims 1-4). Takahashi et al. teaches that the oral cavity composition may be compounded with other known components and prepared into a toothpaste, a liquid dentifrice, a powder dentifrice, a gum-coating agent, etc. (overview).
Takahashi et al. teaches that although components (a) and (b) are contained as essential components, various known components can be contained from the viewpoint of physical properties, dosage form (for example, toothpaste, liquid dentifrice, powder dentifrice, gum coating agent and the like) and the like [0014]. For example, the following components maybe included: a known water-insoluble abrasive, a binder, a wetting agent, a surfactant, a perfume, a bactericide, a preservative, a dye, water, a water-soluble fluoride, silicone and the like can be contained [0015]. Examples of the water-insoluble abrasive include dentifrice calcium hydrogen phosphate, heavy calcium carbonate, light calcium carbonate, calcium pyrophosphate, insoluble sodium metaphosphate, potassium metaphosphate, anhydrous silicic acid, hydrous silicic acid, aluminum silicate, calcium silicate, zirconium silicate, bentonite, zeolite, aluminum oxide, aluminum hydroxide, alumina, resins, and mixtures thereof [0016]. Examples of the binder include sodium carboxymethyl cellulose, methyl cellulose, hydroxyethyl cellulose, alginate, carrageenan, gum arabic, polyvinyl alcohol, tragacanth gum, starch, and sodium polyacrylate [0017]. Takahashi et al. teaches that when the oral composition of the present invention is made into a paste or liquid composition such as toothpaste or liquid dentifrice, the composition preferably contains, as basic components, 10 to 75% by weight of a water-insoluble abrasive, 0.5 to 5% by weight of a binder, and 10 to 85% by weight of a wetting agent and water [0025].
Accordingly, prior to the effective filing date of the claimed invention it would have been obvious to a person of ordinary skill in the art to include typical ingredients in the toothpaste formulation of copending ‘082 including 0.5 to 5% by weight of a binder such as sodium carboxymethyl cellulose, methyl cellulose, hydroxyethyl cellulose, alginate, carrageenan, gum arabic, polyvinyl alcohol, tragacanth gum, starch, or sodium polyacrylate as taught in Takahashi et al. with a reasonable expectation of predictable results. Thus the claims of copending ‘082 in combination with the teachings of Takahashi et al. arrive at the composition as claimed in the instant claims.
This is a provisional nonstatutory double patenting rejection.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-8 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by TAKAHASHI HIROKAZU et al. JP-8-245350 A (see machine English translation provided).
Claims 1-8 and 10 of the instant application claim an oral gel composition to be applied to the gums and to remain thereon for at least 3 minutes, comprising (a) at least 0.00001 and less than 0.5% by weight caffeine and (b) a gelling agent.
With respect to the limitation of “an oral gel” it is noted that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPTQ2d 1161, 1165 (Fed. Cir. 1999). In the instant case, a prior art which discloses a composition comprising the same components as claimed, i.e. caffeine and a gelling agent, said composition will be considered an oral gel composition as claimed.
With regard to the limitation of “to be applied to the gums and to remain thereon for at least 3 minutes”, this limitation is interpreted as an intended use of the claimed composition. It is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). In the instant case, a prior art which discloses a composition comprising the same components as claimed will necessarily be capable of performing the claimed intended use and being applied to the gums to remain thereon for at least 3 minutes.
Takahashi et al. teaches a composition for oral cavities containing a sweet taste-having base agent (e.g. sorbitol) and at least one specific bitter component (b) selected from 8-acetyl sucrose, quinine hydrochloride, quinine sulfate, caffeine and brucine wherein the bitter taste component in the oral cavity composition is contained in an amount of 1×10-6 -1 wt.% (overview and claims 1-4). Takahashi et al. teaches that the sweet base component (a) is selected from the group consisting of sorbitol, glycerin, propylene glycol, sodium saccharin, aspartame, d-xylose , glycyrrhizin, dipotassium glycyrrhizinate, stevia, fructooligosaccharide, licorice extract, and xylitol (overview and claims 1-4). The oral cavity composition may be compounded with other known components and prepared into a toothpaste, a liquid dentifrice, a powder dentifrice, a gum-coating agent, etc. (overview).
Takahashi et al. teaches that although components (a) and (b) are contained as essential components, various known components can be contained from the viewpoint of physical properties, dosage form (for example, toothpaste, liquid dentifrice, powder dentifrice, gum coating agent and the like) and the like [0014]. For example, the following components maybe included: a known water-insoluble abrasive, a binder, a wetting agent, a surfactant, a perfume, a bactericide, a preservative, a dye, water, a water-soluble fluoride, silicone and the like can be contained [0015]. Examples of the water-insoluble abrasive include dentifrice calcium hydrogen phosphate, heavy calcium carbonate, light calcium carbonate, calcium pyrophosphate, insoluble sodium metaphosphate, potassium metaphosphate, anhydrous silicic acid, hydrous silicic acid, aluminum silicate, calcium silicate, zirconium silicate, bentonite, zeolite, aluminum oxide, aluminum hydroxide, alumina, resins, and mixtures thereof [0016]. Examples of the binder include sodium carboxymethyl cellulose, methyl cellulose, hydroxyethyl cellulose, alginate, carrageenan, gum arabic, polyvinyl alcohol, tragacanth gum, starch, and sodium polyacrylate [0017].
Takahashi et al. teaches that when the oral composition is used as a gum coating agent, the oral composition may contain an oily component or a water-soluble polymer, and may further contain a wetting agent, a surfactant, a flavor, a sweetener, a bactericide, a preservative, a dye, water, a water-soluble fluoride, silicone, a physiologically active component, and the like [0027]. Takahashi et al. teaches, as the water-soluble polymer, those exemplified above as the binder can be used, and among them, hydroxyethyl cellulose is particularly preferable [0029].
Takahashi et al. teaches that when the oral composition of the present invention is made into a paste or liquid composition such as toothpaste or liquid dentifrice, the composition preferably contains, as basic components, 10 to 75% by weight of a water-insoluble abrasive, 0.5 to 5% by weight of a binder, and 10 to 85% by weight of a wetting agent and water [0025].
Takahashi et al. specifically teaches Example 4 in Table 1 [0035] (see below) comprising 0.001 wt.% caffeine, 1.0 wt.% carboxymethylcellulose, 1.0 wt.% carrageenan, calcium carbonate, and sorbitol.
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Accordingly, the cited claims of the instant application are anticipated since Takahashi et al. specifically teaches an oral composition which comprises 0.001 wt.% caffeine which is (a) at least 0.00001 and less than 0.5% by weight caffeine and (b) a gelling agent comprising a mixture of the cellulose derivative, carboxymethylcellulose, and carrageenan and further comprising (c) one or more pH regulators, calcium carbonate, and (d) a sugar alcohol sorbitol, that is free of fluorides and/or tin salts and/or chlorhexidine and/or cetylpyridinium chloride and/or triclosan. Moreover, the Takahashi et al. composition contains the gelling agent in an amount of 2.0 wt.% which is in an amount within the claimed range.
Therefore, since Takahashi et al. specifically teaches an oral composition comprising the same components in the same amounts as claimed, the composition of Takahashi et al. is inherently an oral gel composition capable of performing the intended use as claimed and thus is inherently capable of being applied to the gums to remain thereon for at least 3 minutes. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, a rejection under 35 USC 102 is proper. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Accordingly, the cited claims of the instant application are rejected over the teachings of Takahashi et al.
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.
Claims 1-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Cunningham WO 2009/023381 A1.
Claims 1-8 and 10 of the instant application claim an oral gel composition to be applied to the gums and to remain thereon for at least 3 minutes, comprising (a) at least 0.00001 and less than 0.5% by weight caffeine and (b) a gelling agent.
With respect to the limitation of “an oral gel” it is noted that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPTQ2d 1161, 1165 (Fed. Cir. 1999). In the instant case, a prior art which discloses a composition comprising the same components as claimed, i.e. caffeine and a gelling agent will be considered an oral gel composition as claimed.
With regard to the limitation of “to be applied to the gums and to remain thereon for at least 3 minutes”, this limitation is interpreted as an intended use of the claimed composition. It is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). In the instant case, a prior art which discloses a composition comprising the same components as claimed will necessarily be capable of performing the claimed intended use and being applied to the gums to remain thereon for at least 3 minutes.
Cunningham et al. teaches a caffeine gel comprising a combination of: about 0.05% to 5.0% caffeine; about 0.5% to 10% taurine; about 1 % to 20% sugar; about 60% to 95% water; about 0.5% to 5% sodium citrate; about 0.5% to 5% enzyme modified sodium carboxymethyl cellulose; about 0.5% to 5% citric acid; about 0.5% to 5% guar gum; about 0.5% to 5% xanthan gum; about 0.5% to 5% gellan gum; and about 0.5% to 5% flavor additive ([0005] and claim 11). Claim 16 of Cunningham et al. claims a caffeine gel comprising a combination of: about 0.05% to 1.0% caffeine; about 0.5% to 5% taurine; about 5% to 15% sugar; about 75% to 90% water; about 0.1 % to 1 % sodium citrate; about 0.1 % to 1 % enzyme modified sodium carboxymethyl cellulose; about 0.1 % to 2% citric acid; about 0.1 % to 2% guar gum; about 0.1 % to 2% xanthan gum; about 0.1 % to 2% gellan gum; and about 0.1 % to 0.5% flavor additive.
Thus Cunningham et al. teaches an oral gel composition which may comprise (a) at least 0.00001 and less than 0.5% by weight caffeine and (b) a gelling agent including a cellulose derivative, guar gum and xanthan gum, and further comprising (c) one or more pH regulators, sodium citrate and citric acid, and (d) a flavoring agent, that is free of fluorides and/or tin salts and/or chlorhexidine and/or cetylpyridinium chloride and/or triclosan.
Cunningham et al. does not teach the specific amounts of each component as claimed.
However, Cunningham et al. does teach amounts of each component that overlap with the amounts as claimed. For example, the instant claims recite an oral gel composition which comprises at least 0.00001 and less than 0.5% by weight caffeine, and claim 16 of Cunningham et al. claims a caffeine gel comprising about 0.05% to 1.0% caffeine. In addition, the instant claims recite the oral gel composition contains gelling agent in an amount of from 0.01 to 4.0%, and claim 16 of Cunningham et al. claims a caffeine gel comprising about 0.1 % to 1 % enzyme modified sodium carboxymethyl cellulose; about 0.1 % to 2% guar gum; about 0.1 % to 2% xanthan gum; about 0.1 % to 2% gellan gum which totals about 0.4% to about 7% of gelling agent.
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.").
Therefore, since Cunningham et al. teaches an oral gel composition comprising the same components in overlapping amounts, the composition of Cunningham et al. is necessarily capable of performing the intended use as claimed and thus being applied to the gums to remain thereon for at least 3 minutes. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Accordingly, the cited claims of the instant application are rendered obvious over the teachings of Cunningham et al.
Claims 1-8 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Masahito et al. JP-H0624951 A (see machine English Translation).
Claims 1-8 and 10-11 of the instant application claim an oral gel composition to be applied to the gums and to remain thereon for at least 3 minutes, comprising (a) at least 0.00001 and less than 0.5% by weight caffeine and (b) a gelling agent, as well as a method for treatment and/or prevention of periodontitis/gingivitis or gum recession comprising providing said oral gel composition.
With respect to the limitation of “an oral gel” it is noted that if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPTQ2d 1161, 1165 (Fed. Cir. 1999). In the instant case, a prior art which discloses a composition comprising the same components as claimed, i.e. caffeine and a gelling agent, will be considered an oral gel composition as claimed.
With regard to the limitation of “to be applied to the gums and to remain thereon for at least 3 minutes”, this limitation is interpreted as an intended use of the claimed composition. It is respectfully pointed out that a recitation of an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In a claim drawn to a process of making, the intended use must result in a manipulative difference as compared to the prior art. See In re Casey, 152 USPQ (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). In the instant case, a prior art which discloses a composition comprising the same components as claimed, said composition will necessarily be capable of performing the claimed intended use and being applied to the gums to remain thereon for at least 3 minutes.
Masahito et al. teaches an oral composition that suppresses and improves gingival inflammation and is highly effective in preventing alveolar pyorrhea and gingivitis (purpose). Masahito et al. further teaches an oral composition which has an excellent anti-inflammatory effect on the gums [0001]. Masahito et al. teaches that the object of the present invention is to provide an oral composition that can suppress gingival inflammation and is highly effective in preventing periodontitis and pyorrhea and gingivitis [0005]. The oral composition of the invention is characterized by containing powder made by grinding tea leaves obtained by preserving fresh tea leaves under anaerobic conditions and then steam-heating and/or drying them [0006].
Masahito et al. teaches that dental caries, or tooth decay, has traditionally been thought to occur due to the combination of three factors: sucrose present in the mouth, oral bacteria, and tooth quality wherein the mechanism is thought to be as follows: sucrose contained in food and drink is acted upon by glucosyltransferase, an enzyme secreted by oral bacteria such as Streptococcus mutans, to produce glucan, a sticky, insoluble polysaccharide, which forms dental plaque, a bacterial colony [0002]. At the same time, the bacteria in the plaque decompose the sugars to produce acid, which demineralizes the tooth enamel surface and accelerates dental caries [0002].
Masahito et al. teaches that periodontal disease is a disease that occurs in the tissues around the teeth, and if proper care such as brushing your teeth is not taken, the inflammation will become chronic, the tissues that support the teeth will break down, and eventually, you will lose your teeth [0003]. Periodontal disease can manifest in various forms depending on the progression of the condition and the age of the patient [0003]. First, plaque and tartar will adhere to the surface of the teeth at the base, causing the gums surrounding the teeth to swell, become red, and become inflamed and if this inflammation continues for a long time, gaps will form between the teeth and gums, forming periodontal pockets, and as the condition progresses, the alveolar bone at the bottom will gradually disappear [0003]. Periodontal disease is a chronic inflammation that progresses without pain or noticeable symptoms, but it can also be accompanied by bleeding gums, swelling of the gums, bad breath, etc. [0003].
Masahito et al. teaches an oral composition comprising a powder made by grinding tea leaves wherein the powder obtained in this manner contains a large amount of 1-aminobutyric acid, and the oral composition of the present invention containing this extract not only promotes blood circulation in the gums, but also has a synergistic effect of theophylline, which has a peripheral vasodilating effect, caffeine, which has a peripheral nerve stimulating effect, and flavonoids, which have peripheral vasostrengthening and anti-inflammatory effects, which activate the periodontal tissues in the oral cavity and produce a remarkable, rapid blood circulation promoting and anti-inflammatory effect, and furthermore, the moisturizing effect of amino acids such as aspartic acid, glutamic acid, alanine, serine, glutamine, arginine, etc., has a mild effect on the oral cavity [0008].
Masahito et al. teaches that the amount of ground tea leaves used in the oral composition is 0.005 to 10% by weight, preferably 0.01 to 3% by weight, of the total amount of the oral composition as a solid content and if the amount is less than 0.005% by weight, the oral cavity anti-inflammatory effect that is the objective of the present invention will not be achieved to the expected extent, and if the amount exceeds 10% by weight, the effect commensurate with the increase will not be expected, which is economically undesirable [0011]. Examples of the oral composition include toothpaste, powdered toothpaste, troches, paste, and topical agents, as well as chewing gum, candy, gummy candy, and the like [0012].
The other ingredients of oral composition include calcium carbonate, magnesium carbonate, dibasic calcium phosphate, tribasic calcium phosphate, magnesium phosphate, silica, zeolite, sodium metaphosphate, aluminum hydroxide, magnesium hydroxide, calcium pyrophosphate, pengala, calcium sulfate, and the like, which are commonly used as abrasives [0013]. Also usable are binders such as carboxymethylcellulose, sodium carboxymethylcellulose, hydroxyethylcellulose, alginate, carrageenan, gum arabic, polyvinyl alcohol, methylcellulose, magnesium oxide, alumina sol, calcium silicate, pectin, guar gum, kaolin, and xanthan gum, and foaming agents such as sodium lauryl sulfate, sodium dodecylbenzenesulfonate, sodium lauroylsulfoacetate, sodium N-laurylsulfonate, sodium N-lauroylsarcosinate, sucrose fatty acid esters, polyoxyethylene sorbitan, and alkylolamides [0014]. Further, sweeteners such as saccharin sodium, steviosite, glycyrrhizin, chalcone, dihydrochalcone, etc., moisturizers such as glycerin, sorbitol, propylene glycol, polyethylene glycol, xylitol, dipropylene glycol, sodium lactate, maltitol, etc., preservatives such as parahydroxybenzoic acid, flavorings such as peppermint, spearmint essential oil, 1-menthol, etc., aluminum lactate, edetate, coloring matter, BHT, etc. may be used, and other active ingredients may be added as needed, such as lysozyme chloride, dextrose, bacteriolytic enzyme, mutanase, soybean extract, etc. [0015].
Masahito et al. teaches that 100 g of the tea leaves obtained were pulverized in a fine pulverizer and a freeze pulverizer, and sieved to obtain a product that passed an 80 mesh screen wherein the results of the component contents of the pulverized tea leaves obtained by this production method are shown in Table 1 [0017]. Masahito et al. specifically teaches in Table 1 that the crushed tea leaves used for the composition comprises 2.6 mg of caffeine per 100g [0018]. Masahito et al. further exemplifies oral compositions comprising the gelling agents carboxymethyl cellulose sodium or methylcellulose in amounts such as 1.3% and 1% [0020]-[0027].
Masahito et al. does not specifically teach that the composition is formulated to contain at least 0.00001 wt.% and less than 0.5% wt.% caffeine.
However, Masahito et al. teaches that the amount of ground tea leaves used in the oral composition is 0.005 to 10% by weight wherein the crushed tea leaves used for the composition comprises 2.6 mg of caffeine per 100g which is 0.0026% of the ground tea leaves, wherein the caffeine has a peripheral nerve stimulating effect. Masahito et al. teaches that the amount of ground tea leaves used in the oral composition is 0.005 to 10% by weight. Thus the amount of caffeine within the oral composition would range between 1.3 x 10-7 wt.% to 0.00026 wt.%. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (The prior art taught carbon monoxide concentrations of "about 1-5%" while the claim was limited to "more than 5%." The court held that "about 1-5%" allowed for concentrations slightly above 5% thus the ranges overlapped.); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) (Claim reciting thickness of a protective layer as falling within a range of "50 to 100 Angstroms" considered prima facie obvious in view of prior art reference teaching that "for suitable protection, the thickness of the protective layer should be not less than about 10 nm [i.e., 100 Angstroms]." The court stated that "by stating that ‘suitable protection’ is provided if the protective layer is ‘about’ 100 Angstroms thick, [the prior art reference] directly teaches the use of a thickness within [applicant’s] claimed range.").
Thus Masahito et al. teaches an oral composition for the treatment and prevention of gingivitis and periodontitis which comprises overlapping amounts of caffeine and further may contain gelling components including carboxymethyl cellulose sodium or methylcellulose in amounts within the range as claimed. Masahito et al. further teaches the oral composition may comprise additional ingredients such as the pH regulator calcium carbonate and flavoring agents and sugar alcohols such as sorbitol. Masahito et al. further teaches that the composition may be formulated free of fluorides and/or tin salts and/or chlorhexidine and/or cetylpyridinium chloride and/or triclosan.
Therefore, since Masahito et al. specifically teaches an oral composition comprising the same components in overlapping amounts as claimed, the composition of Masahito et al. is necessarily an oral gel composition capable of performing the intended use as claimed and thus is necessarily capable of being applied to the gums to remain thereon for at least 3 minutes. "Products of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
Thus the cited claims of the instant application are rendered obvious in view of the cited prior art teachings.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over TAKAHASHI HIROKAZU et al. JP-8-245350 A (see machine English translation provided) as applied to claims 1-8 and 10 above, and further in view of Masahito et al. JP-H0624951 A (see machine English Translation) and Gallagher et al. (The Journal of Dental Hygiene, Volume 83, Issue 3, Summer 2009, pages 111-116).
Claims 11 and 12 of the instant application claim a method for treatment and/or prevention of periodontitis/gingivitis or gum recession comprising providing an oral gel composition comprising (a) at least 0.00001 and less than 0.5% by weight caffeine and (b) a gelling agent.
Takahashi et al. is as set forth above.
Takahashi et al. does not specifically teach that the composition is for treatment and/or prevention of periodontitis/gingivitis or gum recession.
However, Takahashi et al. teaches a composition for oral cavities wherein the composition is applied to the oral cavity.
Masahito et al. teaches that dental caries, or tooth decay, has traditionally been thought to occur due to the combination of three factors: sucrose present in the mouth, oral bacteria, and tooth quality wherein the mechanism is thought to be as follows: sucrose contained in food and drink is acted upon by glucosyltransferase, an enzyme secreted by oral bacteria such as Streptococcus mutans, to produce glucan, a sticky, insoluble polysaccharide, which forms dental plaque, a bacterial colony [0002]. At the same time, the bacteria in the plaque decompose the sugars to produce acid, which demineralizes the tooth enamel surface and accelerates dental caries [0002].
Masahito et al. teaches that periodontal disease is a disease that occurs in the tissues around the teeth, and if proper care such as brushing your teeth is not taken, the inflammation will become chronic, the tissues that support the teeth will break down, and eventually, you will lose your teeth [0003]. Periodontal disease can manifest in various forms depending on the progression of the condition and the age of the patient [0003]. First, plaque and tartar will adhere to the surface of the teeth at the base, causing the gums surrounding the teeth to swell, become red, and become inflamed and if this inflammation continues for a long time, gaps will form between the teeth and gums, forming periodontal pockets, and as the condition progresses, the alveolar bone at the bottom will gradually disappear [0003]. Periodontal disease is a chronic inflammation that progresses without pain or noticeable symptoms, but it can also be accompanied by bleeding gums, swelling of the gums, bad breath, etc. [0003].
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Takahashi et al. which teaches a composition for oral cavities wherein the composition is applied to the oral cavity, with the teachings of Masahito et al. which teaches that periodontal disease is a disease that occurs in the tissues around the teeth, and if proper care such as brushing your teeth is not taken, the inflammation will become chronic, the tissues that support the teeth will break down, and eventually, you will lose your teeth [0003]. Thus a person or ordinary skill in the art would have been motivated to use the oral composition of Takahashi on the teeth and gums in order to prevent dental caries which will also lead to the prevention of periodontitis/gingivitis and gum recession as taught by Masahito et al..
With respect to claim 12 of the instant application, Gallagher et al. teaches that routine toothbrushing is the principal method by which individuals remove plaque and control plaque-related diseases, such as periodontitis and caries (abstract page 111). Oral health care professionals generally recommend at least 2 minutes brushing with an appropriate technique at least twice a day in order to remove more plaque (page 111). Thus claim 12 of the instant application is rendered obvious since a person of ordinary skill in the art would have been motivated to brush teeth and gums with the oral composition of Takahashi et al. for the recommended minimum of 2 minutes twice per day in order to prevent dental caries and remove plaque with the expectation of prevention of periodontitis/gingivitis and gum recession. Thus since 2 minutes twice per day totals at least 4 minutes per day, claim 12 which requires the composition in the oral cavity between 3 minutes and 72 hours is rendered obvious.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Masahito et al. JP-H0624951 A (see machine English Translation) as applied to claims 1-8 and 10-11 above and further in view of Gallagher et al. (The Journal of Dental Hygiene, Volume 83, Issue 3, Summer 2009, pages 111-116).
Claim 12 of the instant application claims the composition is provided in the oral cavity between 3 minutes and 72 hours.
Masahito et al. is as set forth above.
Masahito et al. does not specifically teach the composition is provided in the oral cavity between 3 minutes and 72 hours.
Gallagher et al. teaches that routine toothbrushing is the principal method by which individuals remove plaque and control plaque-related diseases, such as periodontitis and caries (abstract and page 111). Oral health care professionals generally recommend at least 2 minutes brushing with an appropriate technique at least twice a day in order to remove more plaque (page 111).
Thus claim 12 of the instant application is rendered obvious since a person of ordinary skill in the art would have been motivated to brush teeth and gums with the oral composition of Masahito et al. for the recommended minimum of 2 minutes twice per day in order to prevent remove plaque and prevent and treat periodontitis/gingivitis and gum recession. Thus since 2 minutes twice per day totals at least 4 minutes per day, claim 12 which requires the composition in the oral cavity between 3 minutes and 72 hours is rendered obvious.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Masahito et al. JP-H0624951 A (see machine English Translation) as applied to claims 1-8 and 10-11 above and further in view of Ibsen et al. WO 88/00043.
Claim 9 of the instant application claims the oral gel composition has a pH value in the range from 5.5 to 8.5, more preferably a pH value in the range from 7.0 to 8.0, in particular a pH value of approximately 7.5.
Masahito et al. does not teach the pH of the oral composition.
Ibsen et al. teaches an important feature of a toothpaste is to maintain an acid-base neutrality in the toothpaste so that the toothpaste has a pH of approximately 7 (page 4 lines 18-20). Ibsen et al. teaches the incorporation of sodium or potassium citrate and preferably, citric acid to aid in preventing the formation of and causing the removal of plaque and calculus (page 4 lines 23-27). These ingredients provide no abrasive action, and are preferably used in such proportions as to achieve a substantially neutral if not actually neutral pH (page 4 lines 27-29). The use of citric acid is not absolutely vital, but is a very useful agent in adjusting the pH, because without the citric acid, the pH of the citrate tends to be about 8.5, and the citric acid can be used in small amount to maintain a pH close to or actually at 7.0 (page 4 lines 29-34). Ibsen et al. teaches that in addition to the typical components i.e. an abrasive such as calcium carbonate, a humectant such as sorbitol, a binder such as cellulose derivatives, water, flavoring agents, foaming agents and preservatives, about 1-3 wt.% sodium citrate or 1.1-3.3 wt.% potassium citrate, and citric acid in combination to about 3 wt.% can be used in an amount to adjust the pH somewhere between about 6 and about 7.5 (pages 6-8).
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Masahito et al. which teaches an oral composition for cleaning the teeth and treating and preventing periodontal disease with the teachings of Ibsen et al. which teaches an oral composition for cleaning the teeth wherein an important feature of a toothpaste is to maintain an acid-base neutrality in the toothpaste so that the toothpaste has a pH of approximately 7 and teaches the incorporation of sodium or potassium citrate and preferably, citric acid to aid in preventing the formation of and causing the removal of plaque and calculus. Thus since Ibsen et al. teaches the incorporation of sodium or potassium citrate and preferably, citric acid to aid in preventing the formation of and causing the removal of plaque and calculus and to maintain a pH of the composition to approximately 7, a person of ordinary skill in the art would have been motivated to add pH regulators such as sodium or potassium citrate and citric acid with a reasonable expectation of improving the properties of the composition of Masahito et al.
Thus claim 9 of the instant application is rendered obvious in view of the cited prior art teachings.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over TAKAHASHI HIROKAZU et al. JP-8-245350 A (see machine English translation provided) as applied to claims 1-8 and 10 above, and further in view of Ibsen et al. WO 88/00043.
Claim 9 of the instant application claims the oral gel composition has a pH value in the range from 5.5 to 8.5, more preferably a pH value in the range from 7.0 to 8.0, in particular a pH value of approximately 7.5.
Takahashi et al. does not teach the pH of the oral composition.
Ibsen et al. teaches an important feature of a toothpaste is to maintain an acid-base neutrality in the toothpaste so that the toothpaste has a pH of approximately 7 (page 4 lines 18-20). Ibsen et al. teaches the incorporation of sodium or potassium citrate and preferably, citric acid to aid in preventing the formation of and causing the removal of plaque and calculus (page 4 lines 23-27). These ingredients provide no abrasive action, and are preferably used in such proportions as to achieve a substantially neutral if not actually neutral pH (page 4 lines 27-29). The use of citric acid is not absolutely vital, but is a very useful agent in adjusting the pH, because without the citric acid, the pH of the citrate tends to be about 8.5, and the citric acid can be used in small amount to maintain a pH close to or actually at 7.0 (page 4 lines 29-34). Ibsen et al. teaches that in addition to the typical components i.e. an abrasive such as calcium carbonate, a humectant such as sorbitol, a binder such as cellulose derivatives, water, flavoring agents, foaming agents and preservatives, about 1-3 wt.% sodium citrate or 1.1-3.3 wt.% potassium citrate, and citric acid in combination to about 3 wt.% can be used in an amount to adjust the pH somewhere between about 6 and about 7.5 (pages 6-8).
Accordingly, prior to the effective filing date of the claimed invention, it would have been obvious to a person of ordinary skill in the art to combine the teachings of Takahashi et al. which teaches an oral composition for cleaning the teeth and treating and preventing periodontal disease with the teachings of Ibsen et al. which teaches an oral composition for cleaning the teeth wherein an important feature of a toothpaste is to maintain an acid-base neutrality in the toothpaste so that the toothpaste has a pH of approximately 7 and teaches the incorporation of sodium or potassium citrate and preferably, citric acid to aid in preventing the formation of and causing the removal of plaque and calculus. Thus since Ibsen et al. teaches the incorporation of sodium or potassium citrate and preferably, citric acid to aid in preventing the formation of and causing the removal of plaque and calculus and to maintain a pH of the composition to approximately 7, a person of ordinary skill in the art would have been motivated to add pH regulators such as sodium or potassium citrate and citric acid with a reasonable expectation of improving the properties of the composition of Takahashi et al.
Thus claim 9 of the instant application is rendered obvious in view of the cited prior art teachings.
Conclusion
Claims 1-12 are rejected. No claims are allowed.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM