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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17 and 18 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.
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, claims 17 and 18 recite the broad recitation Vitamin A and Vitamin B2, and the claim also recites beta-carotene and Riboflavin, respectively, which are the narrower statements of the range/limitations. The recitation of “sunflower” and “carnauba” followed by the terms “vegetable” and “natural” also renders the claims vague and indefinite.
Also in claims 17 and 18, the expression “e.g.” as in “Vegetable (e.g. sunflower) oil” and “Natural wax (e.g., Carnauba wax)” 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).
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 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, 13 , 14 and 20 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention.
Claims 1, 13, 14 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oxelio ("Banana flavoured tanning chewable tablets", Mintel, October 2014).
Oxelio is a chewable tanning tablet containing (i) a chewable base comprising a gelling agent (gum Arabic and alginic acid) and a sugar/sugar alcohol (sorbitol and xylitol as sweeteners) and (2) skin color-promoting agents (beta-carotenoid and lycopene from tomato). See instant claim 1.
Regarding claims 13 and 14, the tablet further contains vitamins E and C which that protect skin against oxidative stress and also meet the present claim limitations.
Regarding claim 20, the product package contains 60 units of the chewable tablet. Administering the tanning tablets to a subject for the known purpose is the inherent use of the disclosed product and meets the present claim.
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 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 2-4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Oxelio as applied to claims 1, 13, 14 and 20 as above, and further in view of Francois et al. (FR 2698268 A1, published on May 27, 1994) (“Francois” hereunder).
Oxelio further teaches that the active agents in the tablet protect skin against oxidative stress. Oxelio does not contain the additional agents as defined in the dependent claims.
Francois teaches orally administrable compositions in the form of gelatin glycerin soft capsules for protecting human skin against the effects of UV radiation comprising at least one amino acid selected from tyrosine and phenylalanine (12-350 mg); copper (1-5 mg), carotene (5-50 mg), vitamin E (5-50 mg), vitamin C (10-300 mg), etc. The reference teaches that the composition is formulated as tablet, capsules, pastilles, chewing gum, etc.
It would have been obvious to one of ordinary skill in the art before the time of filing of the present application to modify the Oxelio formulation and adding to the composition tyrosine and copper as motivated by Francois. The skilled artisan would have been motivated to do so, as both are directed to orally administered compositions for protecting skin, Francois teaches that a combination of tyrosine, copper and vitamin has a synergistic skin photoprotective effects. Since Oxelio also contains vitamins and including carotene and vitamins E and C, the skilled artisan would have had a reasonable expectation of successfully producing a stable composition with enhanced skin photoprotection effects.
Regarding claims 3 and 15, Francois teaches L-tyrosine used in Examples.
Regarding claims 4 and 15, Francois teaches using copper citrate as a non-toxic salt of copper suitable for prior art.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Oxelio as applied to claims 1, 13, 14 and 20 as above, and further in view of Bragaglia (US 6254898, published on July 3, 2001).
Oxelio fails to teach additional carotenoids.
Bragaglia discloses a nutraceutical blend for protection from photodamage to the skin and eyes induced by solar radiation, the composition comprising lutein (0.00015-0.15 %) and zeaxanthin (1-2 % of lutein); the composition can be a capsule at a dosage of 150-400 mg and the daily dose of the composition ranges from about 500-1000 mg. The reference teaches that lutein is a potent free radical quencher and protects the skin, and dietary intake of lutein and zeaxanthin has shown lowered risk of developing cataracts. The reference teaches that the composition has antioxidants, anti-inflammatory and tyrosinase activity inhibiting activities. The reference teaches that the nutraceutical blend can be in the form of soft gelatin capsules or tablets.
It would have been obvious to one of ordinary skill in the art before the time of filing of the present application to modify the teachings of Oxelio and add to the composition additional carotenoids such as lutein and zeaxanthin as motivated by Bragaglia. The skilled artisan would have been motivated to do so, as 1) both references are directed to oral dosage forms comprising carotenoids for skin care; and 2) the latter teaches that lutein and zeaxanthin are potent free radical quencher and protects the skin and eyes from photodamages and from developing cataracts. Since Oxelio also contains carotenoids, the skilled artisan would have had a reasonable expectation of successfully producing a stable oral composition with enhanced antioxidant and photoprotection efficacy.
Claims 9 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Oxelio and Bragaglia as applied to claims 1, 6-8, 13, 14 and 20 as above, and further in view of Lorenz (US 6433025 B1, published on August 13, 2002).
Oxelio and Bragaglia fail to teach astaxanthin.
Lorenz teaches an oral capsule comprising astaxanthin. The reference teaches that the antioxidant activity of astaxanthin is 500 times more powerful than vitamin E and 10 times stronger than other carotenoids. The reference further teaches that astaxanthin has shown to enhance and modulate the immune system and retard and prevent sunburns.
It would have been obvious to one of ordinary skill in the art before the time of filing of the present application to modify the teachings of Oxelio and Bragaglia and add to the composition astaxanthin as motivated by Lorenz. The skilled artisan would have been motivated to do so, as 1) all of the references are directed to oral dosage forms for photoprotection of the skin; and 2) Lorenz teaches that astaxanthin is a potent antioxidant that enhances and modulates the immune system and retard and prevent sunburns. Since all of the compositions are suitable for oral dosage forms comprising carotenoids, the skilled artisan would have had a reasonable expectation of successfully producing a stable composition with improved antioxidant and photoprotection efficacy.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Oxelio as applied to claims 1, 13, 14 and 20 as above, and further in view of Kadhum et al. “Usefulness of liquid-crystal oral formulations to enhance the bioavailability and skin tissue targeting of p-amino benzoic acid as a model compound”, E J Pharm Sci vol 88, 10 June 2016, 282-290. (“Kadhum” hereunder)
Oxelio fails to teach PABA.
Kadhum teaches that oral administration of p-amino benzoic acid (PABA) effectively supports skin tissue targeting and more suitable to reach large areas of skin and useful in cosmeceutical dietary and clinical field. PABA is known to protect skin against skin cancers and available as a health supplement (vitamin B10) due to its antioxidant activity.
It would have been obvious to one of ordinary skill in the art before the time of filing the present application to modify the teachings of Oxelio and incorporate to the composition PABA as motivated by Kadhum. The skilled artisan would have been motivated to do so, as 1) both references are directed to oral dosage forms for protection of the skin; and 2) Kadhum teaches that oral administration of PABA is more effective than topical to treat and protects large areas of skin from skin cancers and deliver vitamin B10 as an antioxidant. Since Kadhum teaches oral bioavailability of PABA, the skilled artisan would have had a reasonable expectation of successfully combining the teachings and producing an improved product for skin protection and antioxidant effects.
Claim 10-12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Oxelio as applied to claims 1, 13, 14 and 20 as above, and further in view of Ervin et al. (US 20110313055 A1, published on December 22, 2011) (“Ervin” hereunder).
Oxelio does not disclose the gelling agents of instant claim 10. Oxelio does not specifically disclose a “gummy candy” form of the composition as indicated in present claim 19.
Ervin teaches chew or gummy candy confections comprising vitamins and minerals that support nutritional health. The composition is said to have a good taste, texture, melt, melt and mouth feel flavored chewy or gummy candy without using hydrogenated fats or a high amount of sugar. See [0016]. The reference teaches using gelatin or pectin as a gelling component, a hydrocolloid thickening component or a fiber component. Other than pectin, carrageenan, cellulose gum, gum Arabic, etc. are mentioned as a suitable hydrocolloid. See [0032, 0077, 0080]. Paragraph [0078] discloses suitable active agents for the formulation which include carotenes, lycopene, etc.
It would have been obvious to one of ordinary skill in the art before the time of filing of the present application to modify the teachings of Oxelio and make the oral dosage form in a gummy candy as motivated by Ervin. The skilled artisan would have been motivated to do so, as 1) both references are directed to oral dosage forms for delivery of nutritional supplements; and 2) Ervin teaches a dosage form having a richer taste, texture and mouth feel which resembles a flavored chew confections without using hydrogenated fats or a high amount of sugar. Since the dosage forms of Oxelio and Ervin are suitable for delivery of same vitamin supplements such as beta-carotene, lycopene, etc., the skilled artisan would have had a reasonable expectation of successfully combining the teachings of the references and producing a chewy or gummy candy composition for skin protection, which have an improved taste, texture and mouth feel. See instant claim 19.
Regarding claim 10, using the disclosed gelling agents such as pectin, carrageenan, gelatin, etc. to make the gummy candy formulation of Ervin would have been obvious.
Regarding claim 11, Ervin teaches using a mixture of monosaccharide (e.g., glucose) and a disaccharide (e.g., sucrose). See [0065-0066].
Regarding claim 12, Ervin teaches that the monosaccharide (glucose) can be used in the range of from about 10-40% based on the total weight of the composition; the disaccharide (sucrose) can be in the range of 10-40 %. See [0065-0066]. The reference further teaches that these sweeteners can be provided in part from fruit/vegetable juice, or flavoring agents. Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this case, given the general teachings and suggestions of the amount of sweeteners useful to make the confectionary delivery system, optimizing these concentrations to achieve a targeted sweetness/flavor would have only taken ordinary skill in the art.
Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Oxelio and Francois as applied to claims 1-4, 13-15 and 20 as above, and further in view of Yang, Bragaglia, Lorenz and Ervin.
Oxelio teaches the pack of 60 units of the composition weighs 85 g, which indicates that each unit is about 1417 mg. The concentrations of active ingredients per 1 unit are: beta-carotene 3.4 mg (about 0.2 wt %); lycopene 1 mg (0.07 wt %), selenium 20 microns (0.001 wt%) , zinc 8 mg (0.6 wt%) , vitamin E 8 mg (0.6 wt ), vitamin C 80 mg (5.6 wt %).
The Francois composition contains at least one amino acid selected from tyrosine and phenylalanine (12-350 mg); copper (1-5 mg), carotene (5-50 mg), vitamin E (5-50 mg), vitamin C (10-300 mg), etc.
Oxelio and Francois fail to teach the remaining components of claim 17.
Yang teaches pectin gel oral dosage form for delivery of nutritional supplements. The reference teaches that pectin gel system has more palatable drug formulation which leads to better patient compliance. The reference teaches that the dosage form is “easy to chew”; a significant amount of drugs, fibers, and nutritional supplements can be incorporated without destroying the pleasant tasting chewable pectin matrix. See col. 3, lines 30 – 42. Regarding claim 17, Yang discloses an example formulation containing 1-5 % of pectin, 40-75 % water, which evaporates to 15-20 %, acidulant/buffer not more than about 5 %, 10-60 % sweetener, about 4-20 % or about 4-12 % of insoluble solids, and up to about 2 % of flavor/colorant. See Table 1. The reference teaches that citric acid can be used to adjust the pH to the gelling range of pectin. See col. 5, line 65 – col. 6, line 8.
As for the sweeteners, glucose and sucrose are disclosed. See col. 7, lines 15 – 19.
Bragaglia discloses a nutraceutical blend for protection from photodamage to the skin and eyes, the composition comprising lutein (0.00015-0.15 %) and zeaxanthin (1-2 % of lutein); the composition can be a capsule at a dosage of 150-400 mg and the daily dose of the composition ranges from about 500-1000 mg.
Lorenz teaches an oral capsule comprising astaxanthin. The reference teaches that the antioxidant activity of astaxanthin is 500 times more powerful than vitamin E and 10 times stronger than other carotenoids. The reference further teaches that astaxanthin has shown to enhance and modulate the immune system and retard and prevent sunburns. The reference teaches the amount of astaxanthin is between about 1-100 mg per day, more preferably about 2-10 mg; Example 1 teaches a 500 mg soft gel capsule comprising 1 mg (0.002 %) of pure astaxanthin.
It would have been obvious to one of ordinary skill in the art before the time of filing of the present application to modify the teachings of Oxelio/Francois and make the oral dosage form in a pectin delivery formulation as motivated by Yang. The skilled artisan would have been motivated to do so, as 1) all references are directed to ingestible dosage forms for delivery of nutritional supplements for skin protection; and 2) Yang teaches a dosage form having a pleasant taste and texture which lead to better patient compliance and high loading capacity. Since the dosage forms of Oxelio/Francois and Yang are suitable for delivery of similar compounds, such as vitamins, minerals, etc., the skilled artisan would have had a reasonable expectation of successfully combining the teachings of the references and producing a pectin oral dosage form which has an improved texture and mouth feel and useful in skin protection.
It would have been also obvious to further modify the teachings by incorporating to the composition the additional active ingredients discussed above as motivated by Bragaglia and Lorenz. Since the references are all directed to oral delivery forms comprising supplemental components for protection of skin, the skilled artisan would have had a reasonable expectation of successfully producing an improved oral dosage form with enhanced protection effects.
Regarding the concentration of the active and inactive ingredients, it is well settled in patent law that differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1995).
Regarding the amount of sugars, Yang generally teaches using sugars such as sucrose and glucose in the amount of 10-60 wt %. Ervin teaches chew or gummy candy confections comprising vitamins and minerals that support nutritional health. Ervin teaches that the monosaccharide (glucose) can be used in the range of about 10-40% based on the total weight of the composition; the disaccharide (sucrose) can be in the range of 10-40 %. See [0065-0066]. The reference further teaches that these sweeteners can be provided in part from fruit/vegetable juice, or flavoring agents. In this case, given the general teachings and suggestions of the amount of sweeteners useful to make the confectionary delivery system, optimizing these concentrations to achieve a targeted sweetness/flavor would have only taken ordinary skill in the art.
Regarding the amount of water, Yang teaches that the amount of water can be controlled by the evaporation during the production process. Given the teaching that the Yang final composition contains about 15-20% of water, optimization of the water amount to adjust the hydration level of the final confectionary product (e.g., to make a harder product) would have only taken ordinary skill in the art.
The amounts of pectin, citric acid, flavoring agent/coloring agents in claim 17 are suggested in Yang.
The amounts of vegetable oil, natural wax, and vitamin B2 in claim 17 read on zero.
Regarding the amount of the concentration of the active ingredients (tyrosine, vitamin C, beta-carotene, etc), prior art suggested daily doses or amount per dosage form. Since the composition of claim 17 does not necessarily represent a dose per se, and there is no dosage regime for the product, it is viewed that the weight percentages of the supplemental ingredients would depend on the amount of other co-active ingredients, loading capacity of the formulation, etc. Thus, manipulation of the concentrations of the active ingredients to make a stable, multi-vitamin/mineral dosage form for known skin protection benefits would have only taken ordinary skill in the art.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Francois in view of Yang, Ervin, Kadhum and Foulger (US 20070026109 A1, published on February 1, 2007).
Francois teaches orally administrable compositions in the form of gelatin glycerin soft capsules for protecting human skin against the effects of UV radiation comprising at least one amino acid selected from tyrosine and phenylalanine (12-350 mg); copper (1-5 mg), vitamin E (5-50 mg), vitamin C (10-300 mg), etc. The reference further teaches nicotinic acid or nicotinamide, which are vitamin D, in the amount of 9-90 mg. The reference teaches that the composition is formulated as tablet, capsules, pastilles, chewing gum, etc.
Yang teaches pectin gel oral dosage form for delivery of nutritional supplements. The reference teaches that pectin gel system has more palatable drug formulation which leads to better patient compliance. The reference teaches that the dosage form is “easy to chew”; a significant amount of drugs, fibers, and nutritional supplements can be incorporated without destroying the pleasant tasting chewable pectin matrix. See col. 3, lines 30 – 42. Regarding claim 18, Yang discloses an example formulation containing 1-5 % of pectin, 40-75 % water, which evaporates to 15-20 %, acidulant/buffer not more than about 5 %, 10-60 % sweetener, about 4-20 % or about 4-12 % of insoluble solids, and up to about 2 % of flavor/colorant. See Table 1. The reference teaches that citric acid can be used to adjust the pH to the gelling range of pectin. See col. 5, line 65 – col. 6, line 8.
As for the sweeteners, glucose and sucrose are disclosed. See col. 7, lines 15 – 19.
It would have been obvious to one of ordinary skill in the art before the time of filing of the present application to modify the teachings of Francois and make the oral dosage form in a pectin delivery formulation as motivated by Yang. The skilled artisan would have been motivated to do so, as 1) both references are directed to ingestible dosage forms for delivery of nutritional supplements for skin protection; and 2) Yang teaches a dosage form having a pleasant taste and texture which lead to better patient compliance and high loading capacity. Since the dosage forms of Francois and Yang are suitable for delivery of similar compounds, such as vitamins, etc., the skilled artisan would have had a reasonable expectation of successfully combining the teachings of the references and producing a pectin oral dosage form which has an improved texture and mouth feel and useful in skin protection.
Francois and Yan fail to teach PABA.
Kadhum teaches that oral administration of p-amino benzoic acid (PABA) effectively supports skin targeting and more suitable to reach large areas of skin and useful in cosmeceutical dietary and clinical field. PABA is known to protect skin against skin cancers and available as a health supplement (vitamin B10) due to its antioxidant activity.
PABA is suggested as a treatment for various diseases of the skin including improvement of skin of people suffering from vitiligo and eczema. See Foulger, [0064-0065]. The reference teaches that a recommended dosage is not in excess of 50 mg per day.
It would have been obvious to one of ordinary skill in the art before the time of filing the present application to modify the teachings of Francois/Yang and incorporate to the composition PABA as motivated by Kadhum and Foulger. The skilled artisan would have been motivated to do so, as 1) all the references are directed to oral dosage forms for protection of the skin; and 2) Kadhum teaches oral administration of PABA protects large areas of skin from skin cancers and delivers vitamin B10 as an antioxidant. Since Foulger teaches a safe amount of PABA for oral administration, the skilled artisan would have had a reasonable expectation of successfully combining the teachings of the references and producing a safe and improved product for skin protection and antioxidant effects.
Regarding the concentration of the active and inactive ingredients, it is well settled in patent law that differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller.
Regarding the amount of sugars, Yang generally teaches using sugars such as sucrose and glucose in the amount of 10-60 wt %. Ervin teaches chew or gummy candy confections comprising vitamins and minerals that support nutritional health. Ervin teaches that the monosaccharide (glucose) can be used in the range of from about 10-40% based on the total weight of the composition; the disaccharide (sucrose) can be in the range of 10-40 %. See [0065-0066]. The reference further teaches that these sweeteners can be provided in part from fruit/vegetable juice, or flavoring agents. In this case, given the general teachings and suggestions of the amount of sweeteners useful to make the confectionary delivery system, optimizing the concentration to achieve a targeted sweetness/flavor would have only taken ordinary skill in the art.
Regarding the amount of water, Yang teaches that the amount of water can be controlled by the evaporation. Given the teaching that the Yang final composition contains about 15-20% of water, optimization of the water amount to adjust the hydration level of the final confectionary product (e.g., harder product) would have only taken ordinary skill in the art.
The amounts of pectin, citric acid and flavoring agent in claim 18 are suggested in Yang.
The amounts of zinc citrate, vitamins B2 and B12, vegetable oil and natural wax read on zero.
Regarding the amount of the concentration of the active ingredients (tyrosine, PABA, etc), prior art discloses suggested daily doses or amount per dosage form. Since the composition of claim 18 does not necessarily represent a dose per se, and there is no dosage regime for the product, it is viewed that the weight percentages of the supplemental ingredients would depend on the amount of other co-active ingredients, loading capacity of the formulation, etc. Thus, manipulation of the concentrations of the active ingredients to make a stable, multi-vitamin/mineral dosage form for the expected skin protection benefits would have only taken ordinary skill in the art.
Claims 1 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ervin.
Ervin teaches chew or gummy candy confections comprising vitamins and minerals that support nutritional health. Paragraph [0078] discloses suitable active agents for the formulation which include carotenes, lycopene, etc. The reference teaches using gelatin or pectin as a gelling component, a hydrocolloid thickening component or a fiber component. Other than pectin, carrageenan, cellulose gum, gum Arabic, etc. are mentioned as a suitable hydrocolloid. See [0032, 0077, 0080].
Incorporating the disclosed vitamins such as carotenes, lycopene, etc. into the gummy candy formulation to make a confectionary comprising any of the disclosed vitamin supplement according to the teachings of the references would have been prima facie obvious.
Conclusion
No claims are allowed.
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/GINA C JUSTICE/Primary Examiner, Art Unit 1617
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