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 .
Applicants' arguments, filed May 1, 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims
Claim Rejections - 35 USC § 103 – Obviousness (New Rejections)
1) Claims 16, 19, 21, 24-25, 27 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Kang et al. (KR 20170076147, already of record) in view of Earpina et al. (2020) in further view of Han et al. (KR 20080087617) and Seo et al. (Food Funct, 2014).
Kang et al. disclose a cosmetic composition comprising Indian gooseberry extract. The composition comprising the Indian gooseberry promotes collagen synthesis of fibroblasts of skin to improve wrinkles, promote elasticity, eliminate free radicals and exhibits antioxidative effects, and removes the stratum corneum outside the skin (Abstract) (meeting the methods of the instant claims). Indian gooseberry fruit contains 20 times more vitamin C than oranges, and it is very stable in heat. Therefore, even if exposed to high temperatures for a long time, vitamins are hardly destroyed like freshly harvested from trees. This durability and heat resistance of vitamin C contained in Indian gooseberry is believed to be derived from the tannins contained in it. It is also known that vitamin C is abundant and has excellent whitening and antioxidant effect. The Indian gooseberry extract comprises 0.01 to 50.0% by weight based on the total weight of the cosmetic composition. If the content of the Indian gooseberry extract is less than 0.01% by weight, the skin improvement effect is insignificant.
Kang et al. differ from the instant claims insofar as they do not disclose the content of ellagic acid in the Indian gooseberry extract or barley sprout.
Earpina et al. disclose that ellagic acid and urolithin A have strong anti-inflammatory effect on cells. Muscadine and amla (gooseberry) are very good sources of ellagic acid. Amla (Indian gooseberry) is a good source of ellagic acid and quercetin and has anti-inflammatory, anti-oxidative properties, and anti-diabetic effects. Gallic acid and ellagic acid were major phenolics in AM and comprises 1.29 to 2.42 mg/g.
It would have been obvious to one of ordinary skill in the art to have used an Indian gooseberry extract with a certain ellagic acid concentration because ellagic acid has anti-inflammatory and anti-oxidative properties. This makes it a result effective variable. It would have taken no more than the relative skill in the art to have adjusted the conditions to obtain an extract with the desired amount of ellagic acid to yield the desired therapeutic result.
Kang et al. in view of Earpina et al. differs from the instant claims insofar as it does not disclose barley sprout.
However, Han et al. disclose a beverage product for treatment of atopic dermatitis containing a seed oil plant such as barley sprouts (Abstract). barley sprout, a plant containing a large amount of Super Oxide Dismutase (SOD) among representative antioxidant proteins that removes free radicals that cause arteriosclerosis and various cancers and aging diseases including atopy in the human body. Barley sprouts can accumulate special protein enzymes such as SOD to maintain robust vitality even in severe winter. Barley sprouts contain a large amount of SOD (Super Oxide Dismutase), which removes free radicals. Barley sprouts have become famous since they have been found to correlate with the body's SOD content and longevity. The main culprit of aging is free radicals, and barley sprouts contain SOD, which is thought to have a direct effect on anti-aging and longevity by replacing superoxide, one of the active oxygen in our body, with harmless oxygen. In addition, barley sprouts contain special ingredients such as sodium, potassium, calcium, iron, vitamin A, vitamin B1, vitamin B2, vitamin C, vitamin E, and niacin evenly. The efficacy of barley sprouts is generally known to promote growth hormone distribution in the body to help growth, strengthen immune function, and have a strong antioxidant activity. The barley sprouts may undergo extraction with water or a crushing process (encompassing juicing) (see Examples).
Seo et al. disclose Saponarin (SA), a natural flavonoid, is known for its antioxidant and hepatoprotective activities. SA is the predominant compound (1142.7 ± 0.9 mg per 100 g) in barley sprouts, constituting 72% of the total polyphenol content. SA isolated from barley sprouts exerts anti-inflammatory effects and may be a promising natural anti-inflammatory agent.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added barley sprout or its extract to the compositions of Kang et al. in view of Earpina et al. because it comprises a large amount of SOD, which removes free radicals and leads to anti-aging effects, as disclosed by Han et al. and it comprises saponarin, which has anti-inflammatory and antioxidant effects.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used a barley sprout extract with a certain amount of saponarin because saponarin has anti-inflammatory and antioxidant effects. This makes it a result effective variable. It would have taken no more than the relative skill in the art to have adjusted the conditions to obtain an extract with the desired amount of saponarin to yield the desired therapeutic result.
In regards to the amount of barley sprout extract, the extract has a direct effect on anti-aging and remove free radicals making it a result effective variable. It would have taken no more than the relative skill of one of ordinary skill in the art to have adjusted the amount of barley sprout extract to form a 1:1 ratio, which is encompassed by the recited range, with Indian gooseberry motivated by the desire to arrive at the desired therapeutic effect.
In regards to claims 21 and 29, the combination of references would lead to a complex of Indian gooseberry extract and barley sprout extract. Therefore the combination would have DPPH scavenging activity, elastase inhibition activity, MMP-1 inhibition activity and a hyaluronic acid content increasing effect.
2) Claims 16-17, 19, 21-25, 27 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Aitani et al. (JP 2013040117) in view of Earpina et al. (2020) in further view of Han et al. (KR 20080087617) and Seo et al. (Food Funct, 2014).
Aitani et al. disclose food compositions to promote collagen production to maintain collagen content, promote the prevention/improvement of wrinkles and sagging, and are effective for the improvement of various symptoms caused by dissatisfying collagen production. The collagen production promoter contains a solvent extract of a fruit of Indian gooseberry (Phyllanthus emblica or Emblica officinale), and a solvent extract of coffee beans (Abstract). The Indian gooseberry is also known as amla, Phyllanthus emblica or Emblica officinale. Amla may be used in the form of San Amla PD, which is a water extract in the form of a powder. The collagen production promoter of the present invention has excellent collagen production promotion ability. Therefore, the collagen production promoter of the present invention is suitable as a pharmaceutical composition (for example, an external preparation for skin, an internal medicine), a quasi-drug, a cosmetic material (meeting claim 30), and a food composition such as a supplement or a beverage (meeting claim 22).
Aitani et al. differ from the instant claims insofar as they do not disclose ellagic acid or barley sprout.
Earpina et al. disclose that ellagic acid and urolithin A have strong anti-inflammatory effect on cells. Muscadine and amla (gooseberry) are very good sources of ellagic acid. Amla (Indian gooseberry) is a good source of ellagic acid and quercetin and has anti-inflammatory, anti-oxidative properties, and anti-diabetic effects. Gallic acid and ellagic acid were major phenolics in AM and comprises 1.29 to 2.42 mg/g.
It would have been obvious to one of ordinary skill in the art to have used an Indian gooseberry extract with a certain ellagic acid concentration because ellagic acid has anti-inflammatory and anti-oxidative properties. This makes it a result effective variable. It would have taken no more than the relative skill in the art to have adjusted the conditions to obtain an extract with the desired amount of ellagic acid to yield the desired therapeutic result.
Aitani et al. in view of Earpina et al. differs from the instant claims insofar as it does not disclose barley sprout.
However, Han et al. disclose a beverage product for treatment of atopic dermatitis containing a seed oil plant such as barley sprouts (Abstract). barley sprout, a plant containing a large amount of Super Oxide Dismutase (SOD) among representative antioxidant proteins that removes free radicals that cause arteriosclerosis and various cancers and aging diseases including atopy in the human body. Barley sprouts can accumulate special protein enzymes such as SOD to maintain robust vitality even in severe winter. Barley sprouts contain a large amount of SOD (Super Oxide Dismutase), which removes free radicals. Barley sprouts have become famous since they have been found to correlate with the body's SOD content and longevity. The main culprit of aging is free radicals, and barley sprouts contain SOD, which is thought to have a direct effect on anti-aging and longevity by replacing superoxide, one of the active oxygen in our body, with harmless oxygen. In addition, barley sprouts contain special ingredients such as sodium, potassium, calcium, iron, vitamin A, vitamin B1, vitamin B2, vitamin C, vitamin E, and niacin. The efficacy of barley sprouts is generally known to promote growth hormone distribution in the body to help growth, strengthen immune function, and have a strong antioxidant activity. The barley sprouts may undergo extraction with water or a crushing process (encompassing juicing) (see Examples).
Seo et al. disclose Saponarin (SA), a natural flavonoid, is known for its antioxidant and hepatoprotective activities. SA is the predominant compound (1142.7 ± 0.9 mg per 100 g) in barley sprouts, constituting 72% of the total polyphenol content. SA isolated from barley sprouts exerts anti-inflammatory effects and may be a promising natural anti-inflammatory agent.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have added barley sprout or its extract to the composition of Aitani et al. in view of Earpina et al. because it comprises a large amount of SOD, which removes free radicals and leads to anti-aging effects, as disclosed by Han et al. and it comprises saponarin, which has anti-inflammatory and antioxidant effects, as disclosed by Seo et al.
It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used a barley sprout extract with a certain amount of saponarin because saponarin has anti-inflammatory and antioxidant effects. This makes it a result effective variable. It would have taken no more than the relative skill in the art to have adjusted the conditions to obtain an extract with the desired amount of saponarin to yield the desired therapeutic result.
In regards to the amount of barley sprout extract, the extract has a direct effect on anti-aging and remove free radicals making it a result effective variable. It would have taken no more than the relative skill of one of ordinary skill in the art to have adjusted the amount of barley sprout extract to form a 1:1 ratio, which is encompassed by the recited range, with Indian gooseberry motivated by the desire to arrive at the desired therapeutic effect.
In regards to claims 21 and 29, the combination of references would lead to a complex of Indian gooseberry extract and barley sprout extract. Therefore the combination would have DPPH scavenging activity, elastase inhibition activity, MMP-1 inhibition activity and a hyaluronic acid content increasing effect.
3) Claims 18 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Aitani et al. (JP 2013040117) in view of Earpina et al. (2020) in further view of Han et al. (KR 20080087617) and Seo et al. (Food Funct, 2014) in further view of Easy Ayurveda Hospital.
Aitani et al. in view of Earpina et al., Han et al. and Seo et al. is discussed above and differs from the instant claims insofar as it does not disclose Indian gooseberry extract is obtained from by juicing.
Easy Ayurveda Hospital discloses amla juice benefits. The amla juice may be prepared by crushing the fruit and then pressing it to extract the juice. The juice improves the complexion of skin.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. It would have been obvious to one of ordinary skill in the art prior to filing the instant application to have used cold press to obtain Indian gooseberry extract because it is a method of art to obtain the extract.
Conclusion
Claims 16-19, 21-27 and 29-30 are rejected.
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/LEZAH ROBERTS/ Primary Examiner, Art Unit 1612
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