DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Formal Matters
This Office Action is in response to the claim set filed on 27 February 2024. Claims 1-20 are pending. Claims 1-20 are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statement (IDSs) submitted on 27 February 2024 are noted and the submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the examiner has considered the references. A signed copy is attached herein.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
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 6 recites the broad recitation “a vitamin C” and the claim also recites “preferably L-ascorbic acid , 3-O-ethyl ascorbic acid (ETVC) or a combination thereof” 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.
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 6 recites the broad recitation “a primary polyamine” and the claim also recites “or wherein said primary polyamine is a primary aliphatic lower-alkyl (C1-5) monoamine; a primary aliphatic alkylamine or a primary aliphatic lower-alkyl (C1-5) polyamine; or wherein said primary aliphatic lower-alkyl (C1-5) monoamine is aminoacetonitrile, said primary aliphatic alkylamine is spermine or spermidine and said primary aliphatic lower-alkyl (C1-5) polyamine is putrescine or dansylcadaverine, or wherein said primary polyamine putrescine (1,4-diaminobutane)” which are the narrower statement of the range/limitations. 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 8, 9, and 14-20 are rejected under 35 U.S.C. 103 as being unpatentable Vivier et al. (US 7342045, IDS reference) in view of Ilenchuk et al. (WO 99/51213, IDS reference).
Applicant Claims
Applicant claims a slow release aqueous topical composition comprising the ingredients as recited in the claims and methods of using the compositions. Dependent claims thereof further recite additional features.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Vivier et al. teach a stable solution which comprises more than zero and up to 15% L-ascorbic acid in a carrier comprising 10 to 15% water, 46.8 to 54.7% ethoxydiglycol, 22 to 29% propylene glycol, all percentages given by weight of final composition, the balance to 100% comprising a percentage of at least one anti-oxidant agent, said solution having a pH below 7.0 (see claim 1). The solution as defined in claim 1, wherein the at least one anti-oxidant agent comprises an anti-oxidant plant extract (see claim 2). The solution as defined in claim 2, wherein the anti-oxidant plant extract is a grapefruit plant extract (see claim 3). Vivier et al. further teach as follows in claims 5-10:
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The solution of claim 1, said solution having a pH below 4.17 (see claim 31).
Vivier et al. teach skin appearance and elasticity has always been a cosmetic concern for almost everybody. Skin protection against actinic radiations has become a great health concern over the past ten to twenty years. UV exposure results in the formation of noxious reactive oxygen species (ROS). Skin damages cannot only be life threatening, but they contribute for premature skin ageing (column 1, lines 25-40). Therefore, the above solutions comprising a vitamin C that keeps all its integrity are intended to be used as is or through the making of a composition or a medication, to prevent or to treat any disease or disorder that involves or is caused by ROS or involving collagen synthesis. The disease or disorder includes but is not limited to skin cancer (melanoma), skin irritation or inflammation, dermatitis, skin allergy, psoriasis, acne, eczema, rosacea, radiations exposure including U.V. or sun exposure, depigmentation (skin whitening) and skin ageing (reduction of wrinkles inter alia). Compositions may comprise any suitable carrier which may include structuring agents (oils, fatty acids, surfactants, etc.) and a reducing agent or an anti-oxidant which would increase the stability of the ascorbic acid or which would complement its anti-oxidant properties. Further, compositions comprising any active ingredient which would benefit or not from the protective effect provided by vitamin C against oxidation are within the scope of the invention (see example 7).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Vivier et al. do not specifically teach incorporation of the primary polyamine for instance 1,4-aminobutane (putrescine). This deficiency is cured by the teachings of Ilenchuk et al.
Ilenchuk et al. teach non-toxic polyamines in the palliative treatment of chronic diseases and disorders of epithelial tissue. The effectiveness of treatment is evidenced by alleviation of symptoms and disorders manifesting in epithelial tissue such as skin, including pruritus, erythema, pain, parastesia and general discomfort, due to the topical administration of certain polyamines. Such symptoms arise from and/or are associated with chronic conditions such as: (i) skin diseases such as inflammatory dermatoses which include atopic and contact eczema, including xerosis such as dry skin and Winter itch; (ii) infection of epithelial tissue (eg. nasal, vulvar or anal passages) with trichomonas or fungi, anal fissures, fistula discharge, wound effluent, or surgical wound drainage; (iii) 'secondary disease' in which epithelial tissue exhibits manifestations of the primary underlying disease such as AIDS, chicken pox and metabolic disorders (i.e., diabetes, hepatic and kidney dysfunction and hematopoesis); and (iv) disorders arising out of direct insult to the epithelial tissue following natural (local tumors, hemorrhoids) or surgical intervention and accompanying scar formation or radiation therapy (see abstract). The skin is an organ because it consists of tissues structurally joined together to perform specific activities. It is one of the larger organs of the body in terms of surface area. The skin is complex in structure and performs several functions essential for survival, which may be grouped as follows: maintenance of body temperature, protection by providing a physical barrier that protects underlying tissues from physical abrasion, bacterial invasion, dehydration and ultraviolet radiation; perception of stimuli because the skin contains numerous nerve endings and receptors that detect stimuli related to temperature, touch, pressure and pain: excretion, wherein perspiration assists in the excretion of small amounts of water, salts and several organic compounds ; synthesis of vitamin D: and immunity. From a clinical perspective, the skin reflects physiological and pathological changes in other areas of the body, such that skin chances can be used to aid medical diagnosis (see page 1). compositions containing polyamines an amount which enables them to act as palliative and/or therapeutic agents for skin disorders, wherein the polyamine is selected from the group consisting of aliphatic di- and polyamines with straight or branched chains of length from 2 to 14 carbon atoms long bearing 2 to 6 amine groups, and agmatine: and the pharmaceutically acceptable acid addition salts thereof. The aliphatic di- and polyamines of this invention are derived from alkanes such as n- propane, isopropane. butane, isobutane. tert-butane. hexane. isohexane, heptane, octane, nonane, decane, and dodecane. The corresponding branch chain analogs of these groups are also included. The 2 to 6 amine groups contained by the aliphatic di- and polyamines may be either primary or secondary and may be located either a terminal position, within the alkane chain, or both. Preferred compounds for use in the compositions and methods of the present invention are spermidine (4,4'- imino bis butylamine), spermine, putrescine (1, 4-diaminobutane), and cadaverine (see page 15, lines 5-16). Ilenchuk et al. teach such compositions are envisioned to contain the active ingredient in from about 0.08 to about 8% by weight volume in a cream base. For topical application a concentration from about 0.5 mmoles to about 500 mmoles polyamine in a suitable salt, in the vehicle, wherein the vehicle, between 99.92 and 92% (w/v) of final product is optimal. The approximate therapeutic concentration is two times the tissue concentration, or greater.
Ilenchuk et al. teach in the claims as follows:
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Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to incorporate the polyamine such as 1,4-aminobutane (putrescine) in the composition of Vivier et al. because Ilenchuk et al. teach non-toxic polyamines in the palliative treatment of chronic diseases and disorders of epithelial tissue. The effectiveness of treatment is evidenced by alleviation of symptoms and disorders manifesting in epithelial tissue such as skin, including pruritus, erythema, pain, parastesia and general discomfort, due to the topical administration of certain polyamines. Such symptoms arise from and/or are associated with chronic conditions such as: (i) skin diseases such as inflammatory dermatoses which include atopic and contact eczema, including xerosis such as dry skin and Winter itch; (ii) infection of epithelial tissue (eg. nasal, vulvar or anal passages) with trichomonas or fungi, anal fissures, fistula discharge, wound effluent, or surgical wound drainage; (iii) 'secondary disease' in which epithelial tissue exhibits manifestations of the primary underlying disease such as AIDS, chicken pox and metabolic disorders (i.e., diabetes, hepatic and kidney dysfunction and hematopoesis); and (iv) disorders arising out of direct insult to the epithelial tissue following natural (local tumors, hemorrhoids) or surgical intervention and accompanying scar formation or radiation therapy (see abstract). The skin is an organ because it consists of tissues structurally joined together to perform specific activities. It is one of the larger organs of the body in terms of surface area. The skin is complex in structure and performs several functions essential for survival, which may be grouped as follows: maintenance of body temperature, protection by providing a physical barrier that protects underlying tissues from physical abrasion, bacterial invasion, dehydration and ultraviolet radiation; perception of stimuli because the skin contains numerous nerve endings and receptors that detect stimuli related to temperature, touch, pressure and pain: excretion, wherein perspiration assists in the excretion of small amounts of water, salts and several organic compounds ; synthesis of vitamin D: and immunity. From a clinical perspective, the skin reflects physiological and pathological changes in other areas of the body, such that skin chances can be used to aid medical diagnosis (see page 1). One of ordinary skill in the art would have been motivated to incorporate putrescine because Ilenchuk et al. teach compositions containing polyamines an amount which enables them to act as palliative and/or therapeutic agents for skin disorders, wherein the polyamine is selected from the group consisting of aliphatic di- and polyamines with straight or branched chains of length from 2 to 14 carbon atoms long bearing 2 to 6 amine groups, and agmatine: and the pharmaceutically acceptable acid addition salts thereof. The aliphatic di- and polyamines of this invention are derived from alkanes such as n- propane, isopropane. butane, isobutane. tert-butane. hexane. isohexane, heptane, octane, nonane, decane, and dodecane. The corresponding branch chain analogs of these groups are also included. The 2 to 6 amine groups contained by the aliphatic di- and polyamines may be either primary or secondary and may be located either a terminal position, within the alkane chain, or both. Preferred compounds for use in the compositions and methods of the present invention are spermidine (4,4'- imino bis butylamine), spermine, putrescine (1, 4-diaminobutane), and cadaverine (see page 15, lines 5-16). Ilenchuk et al. teach such compositions are envisioned to contain the active ingredient in from about 0.08 to about 8% by weight volume in a cream base. For topical application a concentration from about 0.5 mmoles to about 500 mmoles polyamine in a suitable salt, in the vehicle, wherein the vehicle, between 99.92 and 92% (w/v) of final product is optimal. The approximate therapeutic concentration is two times the tissue concentration, or greater.
Ilenchuk et al. teach in the claims as follows:
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In the case where the claimed ranges of the amount of ingredients "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775,783,227 USPQ 773,779 (Fed. Cir. 1985). Furthermore, differences in concentration or particle number will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are teach in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). An ordinary skilled artisan would have had a reasonable chance of success to combine the teachings of Vivier et al. and Ilenchuk et al. because both references teach skin topical composition to protect the skin from radiation damages. With respect to the recitation of “a slow release aqueous topical composition” since the combination teachings of the references meet the structure as claimed the slow release property would necessarily be there absent evidence to the contrary.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 10-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vivier et al. (US 7342045, IDS reference) in view of Ilenchuk et al. (WO 99/51213, IDS reference) as applied to claims 1, 8, 9, and 14-20 above, and further in view of Fares et al. (US 2006/0018852, newly cited).
Applicant Claims
Applicant claims a slow release aqueous topical composition comprising the ingredients as recited in the claims and methods of using the compositions. Dependent claims thereof further recite additional features.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of Vivier et al. and Ilenchuk et al. are described above in detail and are incorporated herein by reference.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Vivier et al. do not specifically teach incorporation propylene glycol, butylene glycol, and pentylene glycol in the composition and their respective amounts and ratios. These deficiencies are cured by the teachings of Fares et al.
Fares et al. teach cosmetic and dermatological compositions containing hydrocortisone or a derivative thereof, a glycol and a thickening or gelling agent, and methods of making and using them (see abstract). At least one glycol is present in the compositions of the present invention. Glycols include propylene glycol, butylene glycol, pentylene glycol and hexylene glycol. In some embodiments, more than one glycol is present. Total amount of glycols generally ranges from about 10% to about 99% by weight of the composition. Pentylene glycol is typically present in an amount of about 5% to about 50%, and when present with at least one other glycol, about 7% to about 10% by weight of the composition. Amounts of other glycols also ranges from about 5% to about 50%, and when present with pentylene glycol, about 10% to about 20% by weight of the composition. (paragraph 0081). Compositions may be prepared by incorporating the water in oil emulsion into the remaining components, whereupon the emulsion “inverts” to provide a continuous liquid phase comprising the aqueous medium of the emulsion and any liquid in the composition comprising water or miscible with water. Preferably, essentially all of the polymer is dissolved in the liquid phase. Topically acceptable adjuvants such as the liquid carrier, for example, an alcohol and/or glycol, optionally mixed with water, will then form part of the continuous liquid phase (paragraph 0056).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to incorporate propylene glycol, butylene glycol, and pentylene glycol in the composition of Vivier et al. and Ilenchuk et al. because Fares et al. teach cosmetic and dermatological compositions containing hydrocortisone or a derivative thereof, a glycol and a thickening or gelling agent, and methods of making and using them (see abstract). At least one glycol is present in the compositions of the present invention. One of ordinary skill in the art would have been motivated to include the glycols in amounts as recited because Fares et al. teach that glycols include propylene glycol, butylene glycol, pentylene glycol and hexylene glycol. In some embodiments, more than one glycol is present. Total amount of glycols generally ranges from about 10% to about 99% by weight of the composition. Pentylene glycol is typically present in an amount of about 5% to about 50%, and when present with at least one other glycol, about 7% to about 10% by weight of the composition. Amounts of other glycols also ranges from about 5% to about 50%, and when present with pentylene glycol, about 10% to about 20% by weight of the composition. (paragraph 0081). Compositions may be prepared by incorporating the water in oil emulsion into the remaining components, whereupon the emulsion “inverts” to provide a continuous liquid phase comprising the aqueous medium of the emulsion and any liquid in the composition comprising water or miscible with water. Preferably, essentially all of the polymer is dissolved in the liquid phase. One of ordinary skill in the art would have been motivated to include the glycols because Fares et al. teach that topically acceptable adjuvants such as the liquid carrier, for example, an alcohol and/or glycol, optionally mixed with water, will then form part of the continuous liquid phase (paragraph 0056). The examiner notes that one can calculate an overlapping ratio of the three glycols that can overlap in scope with the instantly claimed ratio since the amount of the glycols clearly overlap in scope with the claimed amounts.
In the case where the claimed ranges of the amount of ingredients and ratios "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775,783,227 USPQ 773,779 (Fed. Cir. 1985). Furthermore, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are teach in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). An ordinary skilled artisan would have had a reasonable chance of success to combine the teachings of Vivier et al., Ilenchuk et al., and Fares et al. because all of the references teach skin topical composition to protect the skin from various damages. With respect to the recitation of “a slow release aqueous topical composition” since the combination teachings of the references meet the structure as claimed the slow release property would necessarily be there absent evidence to the contrary.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable Vivier et al. (US 7342045, IDS reference) in view of Maeda et al. (US 6861050, IDS reference).
Applicant Claims
Applicant claims a slow release aqueous topical composition comprising the ingredients as recited in the claims and methods of using the compositions. Dependent claims thereof further recite additional features.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of Vivier et al. are described in detail above and are incorporated by reference herein.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Vivier et al. do not specifically teach the amount of vitamin C as recited in claim 2. These deficiencies are cured by the teachings of Maeda et al.
Maeda et al. teach a method of preventing darkening of the skin or inhibiting melanization caused by the irradiation of the melanin monomers with long wavelength ultraviolet rays having a wavelength of 320-400 nm as well as a polymerization inhibitor of a biological dihydroxyindole compound comprising 3-O-ethyl ascorbic acid (which the examiner notes that a type of vitamin c) and an external skin treatment composition containing the same (see abstract). A method of inhibiting melanization of melanin monomers in a skin caused by irradiating the melanin monomers with ultraviolet rays having a wavelength of 320-400 nm comprising applying, to the skin, an external skin treatment composition containing a melanization inhibitor for melanin monomers (see claim 1). A method of inhibiting melanization as claimed in claim 1, wherein said melanization inhibitor is vitamin C or its derivative (see claim 2). A method of inhibiting polymerization of a biological dihydroxyindole compound in a skin caused by the irradiation of long wavelength ultraviolet rays having a wavelength of 320-400 nm by applying, to the skin, an external skin treatment composition comprising 3-O-ethyl ascorbic acid (see claim 3). The 3-O-ethyl ascorbic acid can inhibit the polymerization arising due to the biological dihydroxyindole in vivo caused by ultraviolet rays, whereby darkening of the skin was completely prevented. This is unknown up to now (column 2, lines 58-61). The amount of the polymerization inhibitor in the external skin treatment composition of the present invention is 0.001 to 50.0% by weight, preferably 0.01 to 10.0% by weight, in the total weight of the external treatment composition. If the amount is less than 0.001% by weight, the desired effect of the present invention is not sufficiently exhibited, while if the amount is more than 50.0% by weight, preparation of a product is difficult, and therefore these are not preferred. Further, even if included in an amount of more than 10.0% by weight, the great improvement in the effect cannot be seen (column 3, lines 55-65).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to utilize 3-O-ethyl ascorobic acid (ETVC) a type of vitamin C in amounts as recited in claim 2 because Maeda et al. teach a method of preventing darkening of the skin or inhibiting melanization caused by the irradiation of the melanin monomers with long wavelength ultraviolet rays having a wavelength of 320-400 nm as well as a polymerization inhibitor of a biological dihydroxyindole compound comprising 3-O-ethyl ascorbic acid and an external skin treatment composition containing the same (see abstract). A method of inhibiting melanization of melanin monomers in a skin caused by irradiating the melanin monomers with ultraviolet rays having a wavelength of 320-400 nm comprising applying, to the skin, an external skin treatment composition containing a melanization inhibitor for melanin monomers (see claim 1). A method of inhibiting melanization as claimed in claim 1, wherein said melanization inhibitor is vitamin C or its derivative (see claim 2). A method of inhibiting polymerization of a biological dihydroxyindole compound in a skin caused by the irradiation of long wavelength ultraviolet rays having a wavelength of 320-400 nm by applying, to the skin, an external skin treatment composition comprising 3-O-ethyl ascorbic acid (see claim 3). One of ordinary skill in the art would have been motivated to utilize 3-O-ethyl ascorbic acid as the vitamin c type in amounts as recited because Maeda et al. teach that the 3-O-ethyl ascorbic acid can inhibit the polymerization arising due to the biological dihydroxyindole in vivo caused by ultraviolet rays, whereby darkening of the skin was completely prevented. This is unknown up to now (column 2, lines 58-61). The amount of the polymerization inhibitor in the external skin treatment composition of the present invention is 0.001 to 50.0% by weight, preferably 0.01 to 10.0% by weight, in the total weight of the external treatment composition. If the amount is less than 0.001% by weight, the desired effect of the present invention is not sufficiently exhibited, while if the amount is more than 50.0% by weight, preparation of a product is difficult, and therefore these are not preferred. Further, even if included in an amount of more than 10.0% by weight, the great improvement in the effect cannot be seen (column 3, lines 55-65). In the case where the claimed ranges of the amount of ingredients "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775,783,227 USPQ 773,779 (Fed. Cir. 1985). Furthermore, differences in concentration or particle number will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are teach in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). An ordinary skilled artisan would have had a reasonable chance of success to combine the teachings of Vivier et al. and Maeda et al. because both references teach skin topical composition to protect the skin from radiation damages. With respect to the recitation of “a slow release aqueous topical composition” since the combination teachings of the references meet the structure as claimed the slow release property would necessarily be there absent evidence to the contrary.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant application, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable Vivier et al. (US 7342045, IDS reference) in view of Mendoza et al. (US 2015/0118176, IDS reference).
Applicant Claims
Applicant claims a slow release aqueous topical composition comprising the ingredients as recited in the claims.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of Vivier et al. are described above in detail and are incorporated by reference herein.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Vivier et al. do not specifically teach incorporation of betaine and polysorbate 20 in the composition and their amounts as recited in claims 3-4. These deficiencies are cured by the teachings of Mendoza et al.
Mendoza et al. teach in another aspect, there is disclosed a topical skin composition that is formulated as a cream and has a sun protection factor of around 30 comprising any one of, any combination of, or all of oxybenzone, octisalate, octocrylene, homosalate, avobenzone, styrene/acrylates copolymer, water, glycerin, butylene glycol, ethylene/acrylic acid copolymer, Butyrospermum parkii butter, disodium EDTA, and triethanolamine. The composition can further include any one of, any combination of, or all of: glycereth-26, allantoin, xantham gum, panthenol, tocopherol acetate, sodium PCA, benzyl alcohol, PEG-100 stearate, lauramine oxide, C9-15 alkyl phosphate, polymethylsilsesquioxane, methyl trimethicone, acrylates/dimethicone copolymer, trisiloxane, cetearyl alcohol, C12-15 alkyl benzoate, phenethyl benzoate, polyester-7, ceteth-20 phosphate, neopentyl glycol diheptanoate, dimethicone, dipropylene glycol dibenzoate, dicetyl phosphate, caprylyl glycol, methyl trimethicone, methyldihydrojasmonate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, pentylene glycol, squalane, ethylene brassylate, ethyl linalool, PPG-15 stearyl ether benzoate, sorbic acid, polysorbate 60, isobutyl methyl tetrahydropyranol, trimethylbenzenepropanol, sorbitan isostearate, phenylisohexanol, ammonium hydroxide, glyceryl stearate, arachidyl alcohol, potassium cetyl phosphate, steareth-21, hydrogenated palm glycerides, behenyl alcohol, arachidyl glucoside, hydrogenated lecithin, benzyl alcohol, hydroxyethyl acrylate/sodium acryloydimethyl taurate copolymer, C9-15 alkyl phosphate, tocopheryl acetate, phenoxyethanol, ceteryl alcohol, trimethypentanediol/adipic acid/glycerin crosspolymer, isobutyl methyl tetrahydropryranol, adenosine, and sodium benzoate. The composition can further include Opuntia tuna fruit extract. The amounts of the ingredients within the composition can vary (e.g., amounts can be as low as 0.000001% to as high as 70% w/w or any range therein). In one instance, the composition includes 25% to 70% w/w of water, 1% to 10% w/w of glycerin, 0.5% to 6% w/w of butylene glycol, 0.5% to 3% w/w of ethylene/acrylic acid copolymer, 0.5% to 5% w/w of Butyrospermum parkii butter, 0.01% to 0.2% w/w of disodium EDTA, 0.05% to 1% w/w of triethanolamine, and 15% to 30% w/w of a combination of oxybenzone, octisalate, octocrylene, homosalate, avobenzone, and styrene/acrylates copolymer. a method of protecting skin from UV radiation comprising topically applying the composition to skin in need thereof, wherein topical application of said composition protects the skin from UV radiation (see paragraph 0008). In yet another aspect, there is disclosed a topical skin composition formulated as a cream capable of reducing the appearance of dark circles or puffy eyes comprising any one of, any combination of, or all of water, glycerin, butylene glycol, ethylene/acrylic acid copolymer, Butyrospermum parkii butter, disodium EDTA, and triethanolamine. The composition can further include any one of, any combination of, or all of phenoxyethanol, Carbopol Ultrez 10, cetearyl glucoside, chlorphenesin, adenosine, betaine, Hispagel 200 NS, cetearyl alcohol, ceteareth-20, C12-15 alcohols benzoate, hydrogenated polydecene, polyethylene, cetyl esters, behenyl alcohol, eldew PS-304, dipalmit hydroxyproline, dimethicone silicone, Glycacil 2000, and palmitoyl tetrapeptide-7. The composition can further include Opuntia tuna fruit extract. The amounts of the ingredients within the composition can vary (e.g., amounts can be as low as 0.000001% to as high as 70% w/w or any range therein) (paragraph 0009). Non-limiting examples of moisturizing agents that can be used with the compositions of the present invention include polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, polysorbate 85 etc. (paragraph 0044). In certain aspects of the present invention, the compositions do not include an emulsifier. In other aspects, however, the compositions can include one or more emulsifiers. Emulsifiers can reduce the interfacial tension between phases and improve the formulation and stability of an emulsion. The emulsifiers can be nonionic, cationic, anionic, and zwitterionic emulsifiers. Non-limiting examples include esters of glycerin, esters of propylene glycol, fatty acid esters of polyethylene glycol, fatty acid esters of polypropylene glycol, polyethylene glycol 20 sorbitan monolaurate (polysorbate 20), etc. (paragraph 0050). It is contemplated that the compositions of the present invention can include any amount of the ingredients discussed in this specification. The compositions can also include any number of combinations of additional ingredients described throughout this specification (e.g., pigments, or additional cosmetic or pharmaceutical ingredients). The concentrations of the any ingredient within the compositions can vary. In non-limiting embodiments, for example, the compositions can comprise, consisting essentially of, or consist of, in their final form, for example, at least about 0.0001%, 0.0002%, 0.0003%, 0.0004%, 0.0005%, 0.0006%, 0.0007%, 0.0008%, 0.0009%, 0.0010%, 0.0011%, 0.0012%, 0.0013%, 0.0014%, 0.0015%, 0.0016%, 0.0017%, 0.0018%, 0.0019%, 0.0020%, 0.0021%, 0.0022%, 0.0023%, 0.0024%, 0.0025%, 0.0026%, 0.0027%, 0.0028%, 0.0029%, 0.0030%, 0.0031%, 0.0032%, 0.0033%, 0.0034%, 0.0035%, 0.0036%, 0.0037%, 0.0038%, 0.0039%, 0.0040%, 0.0041%, 0.0042%, 0.0043%, 0.0044%, 0.0045%, 0.0046%, 0.0047%, 0.0048%, 0.0049%, 0.0050%, 0.0051%, 0.0052%, 0.0053%, 0.0054%, 0.0055%, 0.0056%, 0.0057%, 0.0058%, 0.0059%, 0.0060%, 0.0061%, 0.0062%, 0.0063%, 0.0064%, 0.0065%, 0.0066%, 0.0067%, 0.0068%, 0.0069%, 0.0070%, 0.0071%, 0.0072%, 0.0073%, 0.0074%, 0.0075%, 0.0076%, 0.0077%, 0.0078%, 0.0079%, 0.0080%, 0.0081%, 0.0082%, 0.0083%, 0.0084%, 0.0085%, 0.0086%, 0.0087%, 0.0088%, 0.0089%, 0.0090%, 0.0091%, 0.0092%, 0.0093%, 0.0094%, 0.0095%, 0.0096%, 0.0097%, 0.0098%, 0.0099%, 0.0100%, 0.0200%, 0.0250%, 0.0275%, 0.0300%, 0.0325%, 0.0350%, 0.0375%, 0.0400%, 0.0425%, 0.0450%, 0.0475%, 0.0500%, 0.0525%, 0.0550%, 0.0575%, 0.0600%, 0.0625%, 0.0650%, 0.0675%, 0.0700%, 0.0725%, 0.0750%, 0.0775%, 0.0800%, 0.0825%, 0.0850%, 0.0875%, 0.0900%, 0.0925%, 0.0950%, 0.0975%, 0.1000%, 0.1250%, 0.1500%, 0.1750%, 0.2000%, 0.2250%, 0.2500%, 0.2750%, 0.3000%, 0.3250%, 0.3500%, 0.3750%, 0.4000%, 0.4250%, 0.4500%, 0.4750%, 0.5000%, 0.5250%, 0.0550%, 0.5750%, 0.6000%, 0.6250%, 0.6500%, 0.6750%, 0.7000%, 0.7250%, 0.7500%, 0.7750%, 0.8000%, 0.8250%, 0.8500%, 0.8750%, 0.9000%, 0.9250%, 0.9500%, 0.9750%, 1.0%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2.0%, 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, 2.6%, 2.7%, 2.8%, 2.9%, 3.0%, 3.1%, 3.2%, 3.3%, 3.4%, 3.5%, 3.6%, 3.7%, 3.8%, 3.9%, 4.0%, 4.1%, 4.2%, 4.3%, 4.4%, 4.5%, 4.6%, 4.7%, 4.8%, 4.9%, 5.0%, 5.1%, 5.2%, 5.3%, 5.4%, 5.5%, 5.6%, 5.7%, 5.8%, 5.9%, 6.0%, 6.1%, 6.2%, 6.3%, 6.4%, 6.5%, 6.6%, 6.7%, 6.8%, 6.9%, 7.0%, 7.1%, 7.2%, 7.3%, 7.4%, 7.5%, 7.6%, 7.7%, 7.8%, 7.9%, 8.0%, 8.1%, 8.2%, 8.3%, 8.4%, 8.5%, 8.6%, 8.7%, 8.8%, 8.9%, 9.0%, 9.1%, 9.2%, 9.3%, 9.4%, 9.5%, 9.6%, 9.7%, 9.8%, 9.9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 35%, 40%, 45%, 50%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 99% or any range derivable therein, of at least one of the ingredients that are mentioned throughout the specification and claims. In non-limiting aspects, the percentage can be calculated by weight or volume of the total composition. A person of ordinary skill in the art would understand that the concentrations can vary depending on the addition, substitution, and/or subtraction of ingredients in a given composition (see paragraph 0035). Mendoza et al. teach a topical skin composition comprising: 25% to 70% w/w of water; 1% to 10% w/w of glycerin; 0.5% to 6% w/w of butylene glycol; 0.5% to 3% w/w of ethylene/acrylic acid copolymer; 0.5% to 5% w/w of Butyrospermum parkii butter; 0.01% to 0.2% w/w of disodium EDTA; and 0.05% to 1% w/w of triethanolamine (see claim 1). The topical skin composition of claim 1, further comprising: oxybenzone; octisalate; octocrylene; homosalate; avobenzone; and styrene/acrylates copolymer (see claim 2). The topical skin composition of claim 2, further comprising: trisiloxane; cetearyl alcohol; C12-15 alkyl benzoate; phenethyl benzoate; polyester-7; ceteth-20 phosphate; neopentyl glycol diheptanoate; dimethicone; dipropylene glycol dibenzoate; dicetyl phosphate; caprylyl glycol; methyl trimethicone; methyldihydrojasmonate; hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer; pentylene glycol; squalane; ethylene brassylate; ethyl linalool; PPG-15 stearyl ether benzoate; sorbic acid; polysorbate 60; isobutyl methyl tetrahydropyranol; trimethylbenzenepropanol; sorbitan isostearate; phenylisohexanol; and ammonium hydroxide. The topical skin composition of claim 2, further comprising: trisiloxane; C12-15 alkyl benzoate; phenethyl benzoate; polyester-7; neopentyl glycol diheptanoate; glyceryl stearate; hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer; dipropylene glycol dibenzoate; arachidyl alcohol; caprylyl glycol; squalane; methyldihydrojasmonate; potassium cetyl phosphate; dimethicone; steareth-21; hydrogenated palm glycerides; pentylene glycol; behenyl alcohol; arachidyl glucoside; ethylene brassylate; PPG-15 stearyl ether benzoate; ethyl linalool; polysorbate 60; hydrogenated lecithin; sorbic acid; isobutyl methyl tetrahydropyranol; trimethylbenzenepropanol; sorbitan isostearate; phenylisohexanol; and ammonium hydroxide (see claim 6).
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to incorporate betaine, polysorbate 20, and also pentylene glycol in the composition of Vivier et al. because Mendoza et al. teach a topical skin composition that is formulated as a cream and has a sun protection factor of around 30 comprising any one of, any combination of, or all of oxybenzone, octisalate, octocrylene, homosalate, avobenzone, styrene/acrylates copolymer, water, glycerin, butylene glycol, ethylene/acrylic acid copolymer, Butyrospermum parkii butter, disodium EDTA, and triethanolamine. The composition can further include any one of, any combination of, or all of: glycereth-26, allantoin, xantham gum, panthenol, tocopherol acetate, sodium PCA, benzyl alcohol, PEG-100 stearate, lauramine oxide, C9-15 alkyl phosphate, polymethylsilsesquioxane, methyl trimethicone, acrylates/dimethicone copolymer, trisiloxane, cetearyl alcohol, C12-15 alkyl benzoate, phenethyl benzoate, polyester-7, ceteth-20 phosphate, neopentyl glycol diheptanoate, dimethicone, dipropylene glycol dibenzoate, dicetyl phosphate, caprylyl glycol, methyl trimethicone, methyldihydrojasmonate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, pentylene glycol, squalane, ethylene brassylate, ethyl linalool, PPG-15 stearyl ether benzoate, sorbic acid, polysorbate 60, isobutyl methyl tetrahydropyranol, trimethylbenzenepropanol, sorbitan isostearate, phenylisohexanol, ammonium hydroxide, glyceryl stearate, arachidyl alcohol, potassium cetyl phosphate, steareth-21, hydrogenated palm glycerides, behenyl alcohol, arachidyl glucoside, hydrogenated lecithin, benzyl alcohol, hydroxyethyl acrylate/sodium acryloydimethyl taurate copolymer, C9-15 alkyl phosphate, tocopheryl acetate, phenoxyethanol, ceteryl alcohol, trimethypentanediol/adipic acid/glycerin crosspolymer, isobutyl methyl tetrahydropryranol, adenosine, and sodium benzoate. The composition can further include Opuntia tuna fruit extract. The amounts of the ingredients within the composition can vary (e.g., amounts can be as low as 0.000001% to as high as 70% w/w or any range therein). In one instance, the composition includes 25% to 70% w/w of water, 1% to 10% w/w of glycerin, 0.5% to 6% w/w of butylene glycol, 0.5% to 3% w/w of ethylene/acrylic acid copolymer, 0.5% to 5% w/w of Butyrospermum parkii butter, 0.01% to 0.2% w/w of disodium EDTA, 0.05% to 1% w/w of triethanolamine, and 15% to 30% w/w of a combination of oxybenzone, octisalate, octocrylene, homosalate, avobenzone, and styrene/acrylates copolymer. a method of protecting skin from UV radiation comprising topically applying the composition to skin in need thereof, wherein topical application of said composition protects the skin from UV radiation (see paragraph 0008). In yet another aspect, there is disclosed a topical skin composition formulated as a cream capable of reducing the appearance of dark circles or puffy eyes comprising any one of, any combination of, or all of water, glycerin, butylene glycol, ethylene/acrylic acid copolymer, Butyrospermum parkii butter, disodium EDTA, and triethanolamine. The composition can further include any one of, any combination of, or all of phenoxyethanol, Carbopol Ultrez 10, cetearyl glucoside, chlorphenesin, adenosine, betaine, Hispagel 200 NS, cetearyl alcohol, ceteareth-20, C12-15 alcohols benzoate, hydrogenated polydecene, polyethylene, cetyl esters, behenyl alcohol, eldew PS-304, dipalmit hydroxyproline, dimethicone silicone, Glycacil 2000, and palmitoyl tetrapeptide-7. The composition can further include Opuntia tuna fruit extract. The amounts of the ingredients within the composition can vary (e.g., amounts can be as low as 0.000001% to as high as 70% w/w or any range therein) (paragraph 0009). Non-limiting examples of moisturizing agents that can be used with the compositions of the present invention include polysorbate 20, polysorbate 40, polysorbate 60, polysorbate 80, polysorbate 85 etc. (paragraph 0044). In certain aspects of the present invention, the compositions do not include an emulsifier. In other aspects, however, the compositions can include one or more emulsifiers. The emulsifiers can be nonionic, cationic, anionic, and zwitterionic emulsifiers. Non-limiting examples include esters of glycerin, esters of propylene glycol, fatty acid esters of polyethylene glycol, fatty acid esters of polypropylene glycol, polyethylene glycol 20 sorbitan monolaurate (polysorbate 20), etc. (paragraph 0050). One of ordinary skill in the art would have been motivated to incorporate polysorbate 20 because Mendoza et al. teach that emulsifiers like polysorbate 20 can reduce the interfacial tension between phases and improve the formulation and stability of an emulsion (paragraph 0050). One of ordinary skill in the art would have been motivated to incorporate betaine because Mendoza et al. teach the use of betaine and its derivatives as moisturizing agents and skin composition enhancers as conventionally known in the art betain will provide silky feel to skin care compositions. It would have been prima facie obvious to a person of ordinary skill in the art at the time of the instant invention was filed to substitute propylene glycol of Vivier et al. by pentylene glycol or add pentylene glycol because the glycols are functionally equivalent. Mendoza et al. teach a topical skin composition comprising: 25% to 70% w/w of water; 1% to 10% w/w of glycerin; 0.5% to 6% w/w of butylene glycol; 0.5% to 3% w/w of ethylene/acrylic acid copolymer; 0.5% to 5% w/w of Butyrospermum parkii butter; 0.01% to 0.2% w/w of disodium EDTA; and 0.05% to 1% w/w of triethanolamine (see claim 1). The topical skin composition of claim 1, further comprising: oxybenzone; octisalate; octocrylene; homosalate; avobenzone; and styrene/acrylates copolymer (see claim 2). The topical skin composition of claim 2, further comprising: trisiloxane; cetearyl alcohol; C12-15 alkyl benzoate; phenethyl benzoate; polyester-7; ceteth-20 phosphate; neopentyl glycol diheptanoate; dimethicone; dipropylene glycol dibenzoate; dicetyl phosphate; caprylyl glycol; methyl trimethicone; methyldihydrojasmonate; hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer; pentylene glycol; squalane; ethylene brassylate; ethyl linalool; PPG-15 stearyl ether benzoate; sorbic acid; polysorbate 60; isobutyl methyl tetrahydropyranol; trimethylbenzenepropanol; sorbitan isostearate; phenylisohexanol; and ammonium hydroxide. The topical skin composition of claim 2, further comprising: trisiloxane; C12-15 alkyl benzoate; phenethyl benzoate; polyester-7; neopentyl glycol diheptanoate; glyceryl stearate; hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer; dipropylene glycol dibenzoate; arachidyl alcohol; caprylyl glycol; squalane; methyldihydrojasmonate; potassium cetyl phosphate; dimethicone; steareth-21; hydrogenated palm glycerides; pentylene glycol; behenyl alcohol; arachidyl glucoside; ethylene brassylate; PPG-15 stearyl ether benzoate; ethyl linalool; polysorbate 60; hydrogenated lecithin; sorbic acid; isobutyl methyl tetrahydropyranol; trimethylbenzenepropanol; sorbitan isostearate; phenylisohexanol; and ammonium hydroxide (see claim 6). With respect to the amount of ingredients Mendoza et al. teach that it is contemplated that the compositions of the present invention can include any amount of the ingredients discussed in this specification. The compositions can also include any number of combinations of additional ingredients described throughout this specification (e.g., pigments, or additional cosmetic or pharmaceutical ingredients). The concentrations of the any ingredient within the compositions can vary.In non-limiting embodiments, for example, the compositions can comprise, consisting essentially of, or consist of, in their final form, for example, at least about 0.0001%, 0.0002%, 0.0003%, 0.0004%, 0.0005%, 0.0006%, 0.0007%, 0.0008%, 0.0009%, 0.0010%, 0.0011%, 0.0012%, 0.0013%, 0.0014%, 0.0015%, 0.0016%, 0.0017%, 0.0018%, 0.0019%, 0.0020%, 0.0021%, 0.0022%, 0.0023%, 0.0024%, 0.0025%, 0.0026%, 0.0027%, 0.0028%, 0.0029%, 0.0030%, 0.0031%, 0.0032%, 0.0033%, 0.0034%, 0.0035%, 0.0036%, 0.0037%, 0.0038%, 0.0039%, 0.0040%, 0.0041%, 0.0042%, 0.0043%, 0.0044%, 0.0045%, 0.0046%, 0.0047%, 0.0048%, 0.0049%, 0.0050%, 0.0051%, 0.0052%, 0.0053%, 0.0054%, 0.0055%, 0.0056%, 0.0057%, 0.0058%, 0.0059%, 0.0060%, 0.0061%, 0.0062%, 0.0063%, 0.0064%, 0.0065%, 0.0066%, 0.0067%, 0.0068%, 0.0069%, 0.0070%, 0.0071%, 0.0072%, 0.0073%, 0.0074%, 0.0075%, 0.0076%, 0.0077%, 0.0078%, 0.0079%, 0.0080%, 0.0081%, 0.0082%, 0.0083%, 0.0084%, 0.0085%, 0.0086%, 0.0087%, 0.0088%, 0.0089%, 0.0090%, 0.0091%, 0.0092%, 0.0093%, 0.0094%, 0.0095%, 0.0096%, 0.0097%, 0.0098%, 0.0099%, 0.0100%, 0.0200%, 0.0250%, 0.0275%, 0.0300%, 0.0325%, 0.0350%, 0.0375%, 0.0400%, 0.0425%, 0.0450%, 0.0475%, 0.0500%, 0.0525%, 0.0550%, 0.0575%, 0.0600%, 0.0625%, 0.0650%, 0.0675%, 0.0700%, 0.0725%, 0.0750%, 0.0775%, 0.0800%, 0.0825%, 0.0850%, 0.0875%, 0.0900%, 0.0925%, 0.0950%, 0.0975%, 0.1000%, 0.1250%, 0.1500%, 0.1750%, 0.2000%, 0.2250%, 0.2500%, 0.2750%, 0.3000%, 0.3250%, 0.3500%, 0.3750%, 0.4000%, 0.4250%, 0.4500%, 0.4750%, 0.5000%, 0.5250%, 0.0550%, 0.5750%, 0.6000%, 0.6250%, 0.6500%, 0.6750%, 0.7000%, 0.7250%, 0.7500%, 0.7750%, 0.8000%, 0.8250%, 0.8500%, 0.8750%, 0.9000%, 0.9250%, 0.9500%, 0.9750%, 1.0%, 1.1%, 1.2%, 1.3%, 1.4%, 1.5%, 1.6%, 1.7%, 1.8%, 1.9%, 2.0%, 2.1%, 2.2%, 2.3%, 2.4%, 2.5%, 2.6%, 2.7%, 2.8%, 2.9%, 3.0%, 3.1%, 3.2%, 3.3%, 3.4%, 3.5%, 3.6%, 3.7%, 3.8%, 3.9%, 4.0%, 4.1%, 4.2%, 4.3%, 4.4%, 4.5%, 4.6%, 4.7%, 4.8%, 4.9%, 5.0%, 5.1%, 5.2%, 5.3%, 5.4%, 5.5%, 5.6%, 5.7%, 5.8%, 5.9%, 6.0%, 6.1%, 6.2%, 6.3%, 6.4%, 6.5%, 6.6%, 6.7%, 6.8%, 6.9%, 7.0%, 7.1%, 7.2%, 7.3%, 7.4%, 7.5%, 7.6%, 7.7%, 7.8%, 7.9%, 8.0%, 8.1%, 8.2%, 8.3%, 8.4%, 8.5%, 8.6%, 8.7%, 8.8%, 8.9%, 9.0%, 9.1%, 9.2%, 9.3%, 9.4%, 9.5%, 9.6%, 9.7%, 9.8%, 9.9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 35%, 40%, 45%, 50%, 60%, 65%, 70%, 75%, 80%, 85%, 90%, 95%, or 99% or any range derivable therein, of at least one of the ingredients that are mentioned throughout the specification and claims. In non-limiting aspects, the percentage can be calculated by weight or volume of the total composition. A person of ordinary skill in the art would understand that the concentrations can vary depending on the addition, substitution, and/or subtraction of ingredients in a given composition (see paragraph 0035). In the case where the claimed ranges of the amount of ingredients "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775,783,227 USPQ 773,779 (Fed. Cir. 1985). Furthermore, differences in concentration or particle number will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are teach in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). An ordinary skilled artisan would have had a reasonable chance of success to combine the teachings of Vivier et al. and Mendoza et al. because both references teach skin topical composition to protect the skin from radiation damages. With respect to the recitation of “a slow release aqueous topical composition” since the combination teachings of the references meet the structure as claimed the slow release property would necessarily be there absent evidence to the contrary.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vivier et al. (US 7342045, IDS reference) in view of Mendoza et al. (US 2015/0118176, IDS reference) as applied to claims 3-5 above, and further in view of Ilenchuk et al. (WO 99/51213, IDS reference).
Applicant Claims
Applicant claims a slow release aqueous topical composition comprising the ingredients as recited in the claims and methods of using the compositions. Dependent claims thereof further recite additional features.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
The teachings of Vivier et al. and Mendoza et al. are described above in detail are incorporated herein by reference.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
Vivier et al. and Mendoza et al. do not specifically teach incorporation of the primary polyamine for instance 1,4-aminobutane (putrescine). This deficiency is cured by the teachings of Ilenchuk et al.
Ilenchuk et al. teach non-toxic polyamines in the palliative treatment of chronic diseases and disorders of epithelial tissue. The effectiveness of treatment is evidenced by alleviation of symptoms and disorders manifesting in epithelial tissue such as skin, including pruritus, erythema, pain, parastesia and general discomfort, due to the topical administration of certain polyamines. Such symptoms arise from and/or are associated with chronic conditions such as: (i) skin diseases such as inflammatory dermatoses which include atopic and contact eczema, including xerosis such as dry skin and Winter itch; (ii) infection of epithelial tissue (eg. nasal, vulvar or anal passages) with trichomonas or fungi, anal fissures, fistula discharge, wound effluent, or surgical wound drainage; (iii) 'secondary disease' in which epithelial tissue exhibits manifestations of the primary underlying disease such as AIDS, chicken pox and metabolic disorders (i.e., diabetes, hepatic and kidney dysfunction and hematopoesis); and (iv) disorders arising out of direct insult to the epithelial tissue following natural (local tumors, hemorrhoids) or surgical intervention and accompanying scar formation or radiation therapy (see abstract). The skin is an organ because it consists of tissues structurally joined together to perform specific activities. It is one of the larger organs of the body in terms of surface area. The skin is complex in structure and performs several functions essential for survival, which may be grouped as follows: maintenance of body temperature, protection by providing a physical barrier that protects underlying tissues from physical abrasion, bacterial invasion, dehydration and ultraviolet radiation; perception of stimuli because the skin contains numerous nerve endings and receptors that detect stimuli related to temperature, touch, pressure and pain: excretion, wherein perspiration assists in the excretion of small amounts of water, salts and several organic compounds ; synthesis of vitamin D: and immunity. From a clinical perspective, the skin reflects physiological and pathological changes in other areas of the body, such that skin chances can be used to aid medical diagnosis (see page 1). compositions containing polyamines an amount which enables them to act as palliative and/or therapeutic agents for skin disorders, wherein the polyamine is selected from the group consisting of aliphatic di- and polyamines with straight or branched chains of length from 2 to 14 carbon atoms long bearing 2 to 6 amine groups, and agmatine: and the pharmaceutically acceptable acid addition salts thereof. The aliphatic di- and polyamines of this invention are derived from alkanes such as n- propane, isopropane. butane, isobutane. tert-butane. hexane. isohexane, heptane, octane, nonane, decane, and dodecane. The corresponding branch chain analogs of these groups are also included. The 2 to 6 amine groups contained by the aliphatic di- and polyamines may be either primary or secondary and may be located either a terminal position, within the alkane chain, or both. Preferred compounds for use in the compositions and methods of the present invention are spermidine (4,4'- imino bis butylamine), spermine, putrescine (1, 4-diaminobutane), and cadaverine (see page 15, lines 5-16). Ilenchuk et al. teach such compositions are envisioned to contain the active ingredient in from about 0.08 to about 8% by weight volume in a cream base. For topical application a concentration from about 0.5 mmoles to about 500 mmoles polyamine in a suitable salt, in the vehicle, wherein the vehicle, between 99.92 and 92% (w/v) of final product is optimal. The approximate therapeutic concentration is two times the tissue concentration, or greater.
Ilenchuk et al. teach in the claims as follows:
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Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the instant application to incorporate the polyamine such as 1,4-aminobutane (putrescine) in the composition of Vivier et al. and Mendoza et al. because Ilenchuk et al. teach non-toxic polyamines in the palliative treatment of chronic diseases and disorders of epithelial tissue. The effectiveness of treatment is evidenced by alleviation of symptoms and disorders manifesting in epithelial tissue such as skin, including pruritus, erythema, pain, parastesia and general discomfort, due to the topical administration of certain polyamines. Such symptoms arise from and/or are associated with chronic conditions such as: (i) skin diseases such as inflammatory dermatoses which include atopic and contact eczema, including xerosis such as dry skin and Winter itch; (ii) infection of epithelial tissue (eg. nasal, vulvar or anal passages) with trichomonas or fungi, anal fissures, fistula discharge, wound effluent, or surgical wound drainage; (iii) 'secondary disease' in which epithelial tissue exhibits manifestations of the primary underlying disease such as AIDS, chicken pox and metabolic disorders (i.e., diabetes, hepatic and kidney dysfunction and hematopoesis); and (iv) disorders arising out of direct insult to the epithelial tissue following natural (local tumors, hemorrhoids) or surgical intervention and accompanying scar formation or radiation therapy (see abstract). The skin is an organ because it consists of tissues structurally joined together to perform specific activities. It is one of the larger organs of the body in terms of surface area. The skin is complex in structure and performs several functions essential for survival, which may be grouped as follows: maintenance of body temperature, protection by providing a physical barrier that protects underlying tissues from physical abrasion, bacterial invasion, dehydration and ultraviolet radiation; perception of stimuli because the skin contains numerous nerve endings and receptors that detect stimuli related to temperature, touch, pressure and pain: excretion, wherein perspiration assists in the excretion of small amounts of water, salts and several organic compounds ; synthesis of vitamin D: and immunity. From a clinical perspective, the skin reflects physiological and pathological changes in other areas of the body, such that skin chances can be used to aid medical diagnosis (see page 1). One of ordinary skill in the art would have been motivated to incorporate putrescine because Ilenchuk et al. teach compositions containing polyamines an amount which enables them to act as palliative and/or therapeutic agents for skin disorders, wherein the polyamine is selected from the group consisting of aliphatic di- and polyamines with straight or branched chains of length from 2 to 14 carbon atoms long bearing 2 to 6 amine groups, and agmatine: and the pharmaceutically acceptable acid addition salts thereof. The aliphatic di- and polyamines of this invention are derived from alkanes such as n- propane, isopropane. butane, isobutane. tert-butane. hexane. isohexane, heptane, octane, nonane, decane, and dodecane. The corresponding branch chain analogs of these groups are also included. The 2 to 6 amine groups contained by the aliphatic di- and polyamines may be either primary or secondary and may be located either a terminal position, within the alkane chain, or both. Preferred compounds for use in the compositions and methods of the present invention are spermidine (4,4'- imino bis butylamine), spermine, putrescine (1, 4-diaminobutane), and cadaverine (see page 15, lines 5-16). Ilenchuk et al. teach such compositions are envisioned to contain the active ingredient in from about 0.08 to about 8% by weight volume in a cream base. For topical application a concentration from about 0.5 mmoles to about 500 mmoles polyamine in a suitable salt, in the vehicle, wherein the vehicle, between 99.92 and 92% (w/v) of final product is optimal. The approximate therapeutic concentration is two times the tissue concentration, or greater.
Ilenchuk et al. teach in the claims as follows:
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In the case where the claimed ranges of the amount of ingredients "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775,783,227 USPQ 773,779 (Fed. Cir. 1985). Furthermore, differences in concentration or particle number will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are teach in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955). An ordinary skilled artisan would have had a reasonable chance of success to combine the teachings of Vivier et al., Mendoza et al., and Ilenchuk et al. because all of the references teach skin topical composition to protect the skin from radiation damages. With respect to the recitation of “a slow release aqueous topical composition” since the combination teachings of the references meet the structure as claimed the slow release property would necessarily be there absent evidence to the contrary.
In light of the forgoing discussion, one of ordinary skill in the art would have concluded that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusions
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/TIGABU KASSA/Primary Examiner, Art Unit 1619
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