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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/23/2026 has been entered.
Status of Claims
Receipt of Remarks/Amendments filed on 07/23/2026 is acknowledged. Claims 1, 6, and 19 are amended and claims 2-5, 7, and 16 are canceled. Claims 21 and 22 are new. Claims 13-15 and 17-20 remain withdrawn as being directed to a non-elected invention. Claims 1, 6, 8-12, and 21-22 are examined on the merits herein.
Priority
The instant application filed 07/27/2023, claims priority to Provisional Application No. 63/392,663, filed 07/27/2022.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6, 8-12, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ianiro, T., et al. (US 10,967,034 B2, 04/06/2021, IDS dated 07/27/2023), hereinafter Ianiro1, in view of Ianiro, T., et al. (US 10,709,751 B2, 07/14/2020, IDS dated 07/27/2023), hereinafter Ianiro2, and Fisher, L., et al. (US 9,132,162 B2, 09/15/2015, IDS dated 07/27/2023), hereinafter Fisher, and Faller, J., et al. (US 8,084,066 B2, 12/27/2011, PTO-892), hereinafter Faller, as evidenced by the Missouri Botanical Garden, Vitis vinifera ‘Chardonnay’, Retrieved 10/23/2025 (on record), hereinafter Missouri Botanical Garden.
Ianiro1 discloses a decolorized muscadine pomace grape extract that can be incorporated into skin care compositions, which can also comprise a grape seed extract. The skin care compositions are applied to the skin to maintain healthy skin without discoloration, protecting against ultraviolet radiation, and inhibiting the production of anti-inflammatory mediators in skin cells (abstract).
Regarding claims 1 and 6: Ianiro1 discloses a topical composition comprising an effective amount of: (a) a decolorized muscadine grape pomace extract, (b) beta-glucan, and (c) grape seed extract (claim 17; col. 23, lines 43-46). The decolorized muscadine grape pomace extract comprises about 9% to about 10% polyphenols and less than about 4% monosaccharides, and wherein the condensed tannins are less than about 10% of the total polyphenol content of the decolorized muscadine pomace extract (claim 13; col. 3, lines 18-24). The grape seed extract included in the topical compositions may be a Vitis vinifera grape seed extract. In particular examples, the grape seed extract contains 38-50% polyphenols, 9-12% fiber, 1-2% protein, 25-30% sugars and less than 1% lipid (col. 26, lines 18-25). The grape seed extract is provided with glycerin/water, therefore reading on a water extract (table 5). Chardonnay grapes are of the species Vitis vinifera, as evidenced by the Missouri Botanical Garden. Thus, it is believed that the grape seed extract of Ianiro1 is identical to the Chardonnay grape seed extract as defined in the instant claims. The topical compositions comprise about 0.001 to about 1.0% of decolorized muscadine pomace solvent extract and about 0.00001% to about 0.1% grape seed extract, with percentages being based upon the total weight of the topical composition (col. 26, lines 26-46).
Regarding claim 8: The decolorized extract can be incorporated into skin care compositions, which can also include beta-glucan and grape seed extract to give the topical composition discussed above. Skin care composition is defined as a topical composition having active ingredients that can improve the health, aesthetic and/or cosmetic appearance of skin (col. 11, lines 1-3).
Regarding claims 9 and 10: The decolorized muscadine pomace extract can be incorporated into a variety of skin care products, such as a retinol serum concentrate, a day moisturizer with sun screen, and facial skin renewal cream (col. 19, lines 55-60), which read on the instantly claimed serum or lotion.
Regarding claim 11: The topical compositions may additionally include other ingredients that are present in a sufficient amount to reduce inflammation when applied to the skin, such as panthenol, Vitamin C and/or superoxide dismutase. For example, the topical compositions include an effective amount of Vitamin A, Vitamin E, or Vitamins A and E (col. 23, lines 46-52; claim 25), which reads on further comprising one or more vitamins.
Ianiro1 also discloses prior work which teaches compositions that combine a muscadine (Vitis rotundifolia) pomace extract having a polyphenol content of at least 2% and trans-resveratrol from a source other than muscadine. The muscadine pomace extract and trans-resveratrol mixture possesses antioxidant activity (col. 13, lines 24-44).
The teachings of Ianiro1 differ from that of the instant invention in that Ianiro1 does not explicitly teach a topical composition comprising resveratrol in combination with both grape extracts, as defined in claims 1 and 6, nor a composition comprising Magnolia officinalis bark extract as recited in claims 1, 6, and 21. Ianiro1 also fails to explicitly teach a composition comprising the specific amounts of the grape extracts and resveratrol, as recited in claim 1 and their ratio, as recited in claim 6. Additionally, it is assumed above that the grape seed extract of Ianiro1 is the same as the Chardonnay grape seed extract of the instant claims, however, in the case that it is not, Ianiro1 does not explicitly teach wherein the grape seed extract is from Chardonnay grapes this limitation is addressed by Ianiro2.
Ianiro2 discloses compositions that comprise an isolated or purified Chardonnay seed extract containing 38-50% polyphenols, 9-12% fiber, 1-2% protein, 25-30% sugars and less than 1% lipid (col. 4, lines 31-41). The Chardonnay seed extract is an extract obtained by extracting the Chardonnay seeds only with water, for example by water solvent extraction (col. 5, lines 4-16). Such an extract reads on the water extract of Chardonnay grape seed, as defined in claims 1 and 6. Grape seed extract is beneficial in many areas of health because of its antioxidant effect to bond with collagen, promoting youthful skin, cell health, elasticity, and flexibility (col. 7, lines 38-40).
As discussed above, Ianiro1 discloses prior work which teaches the combination of a muscadine pomace extract and trans-resveratrol. Reference is made to Fisher which teaches antioxidant compositions that include muscadine pomace extract and resveratrol from a source other than muscadine (abstract), which reads on the resveratrol of instant claims 1 and 6. The compositions increase the expression of antioxidant genes and/or genes associated with mitochondrial biogenesis (abstract). The ratio of muscadine pomace extract polyphenols to trans-resveratrol is in the range of 0.1/1 to 10/1 (weight to weight) (col. 1, lines 8-11). Specifically, a composition containing Japanese knotweed extract, standardized to 98% trans-resveratrol, in combination with a muscadine pomace extract has improved lipophilic antioxidant capacity when compared to the sum of the lipophilic antioxidant capacities contributed by the individual extracts contained in the composition. Lipophilic antioxidants have been found to be effective in reducing various types of skin damage by inhibiting lipid peroxidation and the products produced by lipid peroixdation. Since oxidative stress is a central mechanism underlying normal aging, the disclosed antioxidant compositions are useful for inhibiting free radical production or activity, thereby slowing processes associated with cellular aging (col. 10, lines 35-54). Example 3 demonstrated a strong synergistic effect of the muscadine pomace extract and an additional source of resveratrol, such as Japanese knotweed root extract, as an anti-aging composition in producing lipophilic antioxidant capacity (col. 25, lines 35-39). Fisher specifically teaches a method of improving skin quality by inhibiting or reducing free radical formation or activity in a skin cell by applying a solution or topical ointment containing a muscadine pomace extract either alone or in combination with additional active ingredients, including resveratrol (col. 17-18, lines 65-3).
Faller discloses a method of increasing firmness or elasticity or reducing the appearance of sagginess in the periorbital area of a person's skin, comprising topically applying to the skin in need thereof a composition comprising magnolia extract and Vitis vinifera extract (abstract; claim 1). The magnolia extract can be in the composition from about 0.1% to about 10.0% by weight (col. 4, lines 29-30). The Magnolia bark extract is Magnolia officinalis bark extract (claim 3; col. 7, line 36), which reads on that of claims 1, 6, and 21. Magnolia extract works by reducing the blood flow near the skin surface though a variety of ways (e.g., vasoconstriction, inhibition of angiogenesis, endothelial cell migration, or tube formation in or near the skin area that has been contacted with a composition containing Magnolia extract) (col. 7, lines 43-47).
First, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to use the water extract of Chardonnay grape seeds taught by Ianiro2 as the grape seed extract of Ianiro1 since it is a known and routine grape seed extract in the art. One of ordinary skill in the art could have performed simple substitution of one known grape seed extract for another to predictably yield the instant invention. See MPEP 2143. Additionally, one of ordinary skill in the art would have been motivated to use the Chardonnay grape seed extract of Ianiro2 due to its known antioxidant activity which is beneficial in skin care. One of ordinary skill in the art would have had a reasonable expectation of success in making such a substitution since the grape seed extract of Ianiro1 and the Chardonnay seed extract of Ianiro2 comprise the same dry weight percentages of polyphenols, fiber, protein, lipids, and sugars. Furthermore, the grape seed extract of Ianiro1 is from a Vitis vinifera grape which includes Chardonnay grapes.
It would have been further prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to add the resveratrol of Fisher into the combined composition above since resveratrol is a known and routine active in the art, as taught by Ianiro1 and Fisher. One of ordinary skill in the art would have been motivated to add resveratrol into the combined topical composition above since resveratrol and muscadine pomace extract, which is already present in the composition, are known to have strong synergistic effects in terms of antioxidant activity and anti-aging. It is further noted that Fisher teaches topical compositions comprising resveratrol for improving skin quality, while Ianiro1 similarly teaches topical compositions for skin care that improve the health and appearance of skin. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One of ordinary skill in the art would have had a reasonable expectation of success in incorporating the resveratrol of Fisher into the combined topical composition since Ianiro1 welcomes additional active ingredients and resveratrol is especially effective in combination with muscadine pomace extract.
Regarding the amount of the decolorized muscadine grape pomace extract as recited in claim 1, the instantly claimed amount of 0.10% falls within the range taught by Ianiro1 (i.e., 0.001 to about 1.0%). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding the amount of the grape seed extract as recited in claim 1, the instantly claimed amount of 0.025% falls within the range taught by Ianiro1 (i.e., 0.00001% to about 0.1%). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding the amount of resveratrol as recited in claim 1, Fisher teaches a ratio of muscadine pomace extract polyphenols to trans-resveratrol in the range of 0.1/1 to 10/1. It would have been prima facie obvious to one of ordinary skill in the art to optimize the amount of resveratrol in the final composition, using the ratio of Fisher as guidance, to arrive at the instantly claimed amount of resveratrol. It is well within the abilities of an ordinary artisan to optimize the amount of resveratrol in the composition depending on the desired antioxidant properties of the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed amount of resveratrol (i.e., 0.075%) through no more than routine experimentation. Generally, differences in concentration or temperature 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding the ratio of the components as recited in claim 6, the combined topical composition comprises varying amounts of each ingredient as discussed above. While there is no explicit teaching of a three-part ratio, it would have been prima facie obvious to one of ordinary skill in the art to adjust such a ratio by changing the amounts of each ingredient depending on the desired properties of the final product. As such, one of ordinary skill in the art would have arrived at the claimed ratio through no more than routine experimentation. Moreover, upon the optimization of each component to the amounts described above (i.e., 0.10% of grape pomace extract; 0.025% of grape seed extract; 0.075% of resveratrol), the instantly claimed ratio of claim 6 (i.e., 10:2.5:7.5) is simultaneously met.
Regarding the Magnolia officinalis bark extract as recited in claims 1 and 6, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to incorporate the Magnolia officinalis bark extract of Faller into the combined composition above since it is a known and routine active in that art as taught by Faller. One of ordinary skill in the art would have been motivated to add Magnolia officinalis bark extract into the combined composition since it increases firmness and elasticity of a person's skin by reducing the blood flow near the skin surface, as taught by Faller. It is further noted that Faller teaches topical application of Magnolia officinalis bark extract for improving skin appearance, while Ianiro1 similarly teaches topical compositions for skin care that improve the health and appearance of skin. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One of ordinary skill in the art would have had a reasonable expectation of success in incorporating the Magnolia officinalis bark extract of Faller into the combined topical composition since Ianiro1 welcomes additional active ingredients and Faller explicitly teaches the use of Magnolia officinalis bark extract in combination with Vitis vinifera extract, which is already present in the combined composition.
Regarding the amount of the Magnolia officinalis bark extract as recited in claim 21, it would have been prima facie obvious to one of ordinary skill in the art to incorporated the Magnolia extract in a composition at an amount of 0.1% to 10.0% by weight, since this is a known and effective amount of Magnolia extract to include in a topical skincare composition for improving the appearance of skin. The instantly claimed amount of 3.46% by weight falls within this range. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claim 12, because the composition made obvious by the prior art is identical to the composition claimed, the composition must necessarily have the characteristics claimed as an inherent property. It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter, which there is reason to believe inherently includes functions that are newly cited, or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to “prove that subject matter to be shown in the prior art does not possess the characteristic relied on” (205 USPQ 594). There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ianiro, T., et al. (US 10,967,034 B2, 04/06/2021, IDS dated 07/27/2023), hereinafter Ianiro1, in view of Ianiro, T., et al. (US 10,709,751 B2, 07/14/2020, IDS dated 07/27/2023), hereinafter Ianiro2, and Fisher, L., et al. (US 9132162 B2, 09/15/2015, IDS dated 07/27/2023), hereinafter Fisher, as evidenced by the Missouri Botanical Garden, Vitis vinifera ‘Chardonnay’, Retrieved 10/23/2025 (on record), hereinafter Missouri Botanical Garden.
Ianiro1 discloses a decolorized muscadine pomace grape extract that can be incorporated into skin care compositions, which can also comprise a grape seed extract. The skin care compositions are applied to the skin to maintain healthy skin without discoloration, protecting against ultraviolet radiation, and inhibiting the production of anti-inflammatory mediators in skin cells (abstract).
Regarding claim 22: Ianiro1 discloses a topical composition comprising an effective amount of: (a) a decolorized muscadine grape pomace extract, (b) beta-glucan, and (c) grape seed extract (claim 17; col. 23, lines 43-46). The decolorized muscadine grape pomace extract comprises about 9% to about 10% polyphenols and less than about 4% monosaccharides, and wherein the condensed tannins are less than about 10% of the total polyphenol content of the decolorized muscadine pomace extract (claim 13; col. 3, lines 18-24). The grape seed extract included in the topical compositions may be a Vitis vinifera grape seed extract. In particular examples, the grape seed extract contains 38-50% polyphenols, 9-12% fiber, 1-2% protein, 25-30% sugars and less than 1% lipid (col. 26, lines 18-25). The grape seed extract is provided with glycerin/water, therefore reading on a water extract (table 5). Chardonnay grapes are of the species Vitis vinifera, as evidenced by the Missouri Botanical Garden. Thus, it is believed that the grape seed extract of Ianiro1 is identical to the Chardonnay grape seed extract as defined in the instant claims. The topical compositions comprise about 0.001 to about 1.0% of decolorized muscadine pomace solvent extract and about 0.00001% to about 0.1% grape seed extract, with percentages being based upon the total weight of the topical composition (col. 26, lines 26-46).
Ianiro1 also discloses prior work which teaches compositions that combine a muscadine (Vitis rotundifolia) pomace extract having a polyphenol content of at least 2% and trans-resveratrol from a source other than muscadine. The muscadine pomace extract and trans-resveratrol mixture possesses antioxidant activity (col. 13, lines 24-44).
The teachings of Ianiro1 differ from that of the instant invention in that Ianiro1 does not explicitly teach a topical composition comprising resveratrol in combination with both grape extracts, as defined in claim 22, nor the specific amounts of the grape extracts and resveratrol. Additionally, it is assumed above that the grape seed extract of Ianiro1 is the same as the Chardonnay grape seed extract of the instant claims, however, in the case that it is not, Ianiro1 does not explicitly teach wherein the grape seed extract is from Chardonnay grapes this limitation is addressed by Ianiro2
Ianiro2 discloses compositions that comprise an isolated or purified Chardonnay seed extract containing 38-50% polyphenols, 9-12% fiber, 1-2% protein, 25-30% sugars and less than 1% lipid (col. 4, lines 31-41). The Chardonnay seed extract is an extract obtained by extracting the Chardonnay seeds only with water, for example by water solvent extraction (col. 5, lines 4-16). Such an extract reads on the water extract of Chardonnay grape seed, as defined in claim 22. Grape seed extract is beneficial in many areas of health because of its antioxidant effect to bond with collagen, promoting youthful skin, cell health, elasticity, and flexibility (col. 7, lines 38-40).
As discussed above, Ianiro1 discloses prior work which teaches the combination of a muscadine pomace extract and trans-resveratrol. Reference is made to Fisher which teaches antioxidant compositions that include muscadine pomace extract and resveratrol from a source other than muscadine (abstract), which reads on the resveratrol of claim 22. The compositions increase the expression of antioxidant genes and/or genes associated with mitochondrial biogenesis (abstract). The ratio of muscadine pomace extract polyphenols to trans-resveratrol is in the range of 0.1/1 to 10/1 (weight to weight) (col. 1, lines 8-11). Specifically, a composition containing Japanese knotweed extract, standardized to 98% trans-resveratrol, in combination with a muscadine pomace extract has improved lipophilic antioxidant capacity when compared to the sum of the lipophilic antioxidant capacities contributed by the individual extracts contained in the composition. Lipophilic antioxidants have been found to be effective in reducing various types of skin damage by inhibiting lipid peroxidation and the products produced by lipid peroxidation. Since oxidative stress is a central mechanism underlying normal aging, the disclosed antioxidant compositions are useful for inhibiting free radical production or activity, thereby slowing processes associated with cellular aging (col. 10, lines 35-54). Example 3 demonstrated a strong synergistic effect of the muscadine pomace extract and an additional source of resveratrol, such as Japanese knotweed root extract, as an anti-aging composition in producing lipophilic antioxidant capacity (col. 25, lines 35-39). Fisher specifically teaches a method of improving skin quality by inhibiting or reducing free radical formation or activity in a skin cell by applying a solution or topical ointment containing a muscadine pomace extract either alone or in combination with additional active ingredients, including resveratrol (col. 17-18, lines 65-3).
First, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to use the water extract of Chardonnay grape seeds taught by Ianiro2 as the grape seed extract of Ianiro1 since it is a known and routine grape seed extract in the art. One of ordinary skill in the art could have performed simple substitution of one known grape seed extract for another to predictably yield the instant invention. See MPEP 2143. Additionally, one of ordinary skill in the art would have been motivated to use the Chardonnay grape seed extract of Ianiro2 due to its known antioxidant activity which is beneficial in skin care. One of ordinary skill in the art would have had a reasonable expectation of success in making such a substitution since the grape seed extract of Ianiro1 and the Chardonnay seed extract of Ianiro2 comprise the same dry weight percentages of polyphenols, fiber, protein, lipids, and sugars. Furthermore, the grape seed extract of Ianiro1 is from a Vitis vinifera grape which includes Chardonnay grapes.
It would have been further prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to add the resveratrol of Fisher into the combined composition above since resveratrol is a known and routine active in the art, as taught by Ianiro1 and Fisher. One of ordinary skill in the art would have been motivated to add resveratrol into the combined topical composition above since resveratrol and muscadine pomace extract, which is already present in the composition, are known to have strong synergistic effects in terms of antioxidant activity and anti-aging. It is further noted that Fisher teaches topical compositions comprising resveratrol for improving skin quality, while Ianiro1 similarly teaches topical compositions for skin care that improve the health and appearance of skin. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). One of ordinary skill in the art would have had a reasonable expectation of success in incorporating the resveratrol of Fisher into the combined topical composition since Ianiro1 welcomes additional active ingredients and resveratrol is especially effective in combination with muscadine pomace extract.
Regarding the amount of the decolorized muscadine grape pomace extract as recited in claim 22, the instantly claimed amount of 0.10% falls within the range taught by Ianiro1 (i.e., 0.001 to about 1.0%). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding the amount of the grape seed extract as recited in claim 22, the instantly claimed amount of 0.025% falls within the range taught by Ianiro1 (i.e., 0.00001% to about 0.1%). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding the amount of resveratrol as recited in claim 22, Fisher teaches a ratio of muscadine pomace extract polyphenols to trans-resveratrol in the range of 0.1/1 to 10/1. It would have been prima facie obvious to one of ordinary skill in the art to optimize the amount of resveratrol in the final composition, using the ratio of Fisher as guidance, to arrive at the instantly claimed amount of resveratrol. It is well within the abilities of an ordinary artisan to optimize the amount of resveratrol in the composition depending on the desired antioxidant properties of the final product. As such, one of ordinary skill in the art would have arrived at the instantly claimed amount of resveratrol (i.e., 0.075%) through no more than routine experimentation. Generally, differences in concentration or temperature 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 6, 8-12, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13 and 17 of U.S. Patent No. 10,967,034 in view of Ianiro2, Fisher, and Faller (above). The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Ianiro2, Fisher, and Faller.
US’034 claims a topical composition comprising an effective amount of: (a) a decolorized muscadine grape pomace extract, (b) beta-glucan, and (c) grape seed extract, wherein (a) comprises about 9% to about 10% polyphenols and less than about 4% monosaccharides, and wherein the condensed tannins are less than about 10% of the total polyphenol content of the decolorized muscadine pomace extract (claims 13 and 17).
The claims of US’034 differ from the instant claims in that the US’034 claims do not explicitly recite the Chardonnay grape seed extract or resveratrol of claims 1, 6, and 22, nor do the US’034 claims define the amount of each ingredient and the ratio as defined in the instant claims, nor the Magnolia officinalis bark extract of claims 1 and 6.
Ianiro2 discloses compositions that comprise an isolated or purified Chardonnay seed extract containing 38-50% polyphenols, 9-12% fiber, 1-2% protein, 25-30% sugars and less than 1% lipid (col. 4, lines 31-41). The Chardonnay seed extract is an extract obtained by extracting the Chardonnay seeds only with water (col. 5, lines 4-16). Grape seed extract is beneficial in many areas of health because of its antioxidant effect to bond with collagen, promoting youthful skin, cell health, elasticity, and flexibility (col. 7, lines 38-40).
Fisher teaches antioxidant compositions that include muscadine pomace extract and resveratrol from a source other than muscadine. The compositions increase the expression of antioxidant genes and/or genes associated with mitochondrial biogenesis (abstract). The ratio of muscadine pomace extract polyphenols to trans-resveratrol is in the range of 0.1/1 to 10/1 (weight to weight) (col. 1, lines 8-11). Example 3 demonstrated a strong synergistic effect of the muscadine pomace extract and an additional source of resveratrol, such as Japanese knotweed root extract, as an anti-aging composition in producing lipophilic antioxidant capacity (col. 25, lines 35-39). US’162 specifically teaches a method of improving skin quality by inhibiting or reducing free radical formation or activity in a skin cell by applying a solution or topical ointment containing a muscadine pomace extract either alone or in combination with additional active ingredients, including resveratrol (col. 17-18, lines 65-3).
Faller discloses a method of increasing firmness or elasticity or reducing the appearance of sagginess in the periorbital area of a person's skin, comprising topically applying to the skin in need thereof a composition comprising magnolia extract and Vitis vinifera extract (abstract; claim 1). The magnolia extract can be in the composition from about 0.1% to about 10.0% by weight (col. 4, lines 29-30). The Magnolia bark extract is Magnolia officinalis bark extract (claim 3; col. 7, line 36). Magnolia extract works by reducing the blood flow near the skin surface though a variety of ways (e.g., vasoconstriction, inhibition of angiogenesis, endothelial cell migration, or tube formation in or near the skin area that has been contacted with a composition containing Magnolia extract) (col. 7, lines 43-47).
It would have been prima facie obvious to one of ordinary skill in the art to incorporate the Chardonnay grape seed extract of Ianiro2, the resveratrol of Fisher, and the Magnolia officinalis bark extract of Faller, into the composition of US’034 since each are known and routine actives in the art. It would have been obvious to use the water extract of Chardonnay grape seed as taught by Ianiro2 as the grape seed extract in the topical composition of US’034 since it entails no more than simple substitution of one known element for another to give predictable results. One of ordinary skill in the art would have been motivated to add the resveratrol of Fisher into the topical composition of US’034 since Fisher teaches a strong synergistic effect between muscadine pomace extract and an additional source of resveratrol, which leads to a benefit in skin quality. Lastly, one of ordinary skill in the art would have been motivated to add Magnolia officinalis bark extract into the composition since it increases firmness and elasticity of a person's skin by reducing the blood flow near the skin surface, as taught by Faller.
Regarding the amounts and ratio of the components in the combined topical composition, one of ordinary skill in the art would have arrived at the instantly claimed amounts and ratios of instant claims 1, 6, and 22 through no more than routine experimentation depending on the desired properties of the final product. Generally, differences in concentration or temperature 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 1, 6, 8-12, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 10,709,751 in view of Ianiro1, Fisher, and Faller (above). The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Ianiro1, Fisher, and Faller.
US’751 claims a composition comprising an effective amount of a water extract of Chardonnay grape seed and a pharmaceutically acceptable carrier, wherein the extract consists essentially of Fraction B or C which comprise by percentage dry weight: Fraction B: 38-50% Polyphenols, 9-12% Fiber, 1-2% Protein, <1% Lipids, 25-30% Sugars; and Fraction C: 45-55% Polyphenols, 26-30% Fiber, 2-3% Proteins, <1% Lipids, <1% Sugars; wherein the extract is obtained by the steps of: (a) mixing washed grape seeds with heated water at a temperature below 100° C (claim 1).
The claims of US’751 differ from the instant claims in that the US’751 claims do not explicitly recite the decolorized muscadine grape pomace extract or resveratrol of claims 1, 6, and 22, nor do the US’751 claims define the amount of each ingredient and the ratio as defined in the instant claims, nor the Magnolia officinalis bark extract of claims 1 and 6.
Ianiro1 discloses a topical composition comprising an effective amount of: (a) a decolorized muscadine grape pomace extract, (b) beta-glucan, and (c) grape seed extract (claim 17; col. 23, lines 43-46). The decolorized muscadine grape pomace extract comprises about 9% to about 10% polyphenols and less than about 4% monosaccharides, and wherein the condensed tannins are less than about 10% of the total polyphenol content of the decolorized muscadine pomace extract (claim 13; col. 3, lines 18-24). The grape seed extract included in the topical compositions may be a Vitis vinifera grape seed extract. In some examples, the grape seed extract has a total polyphenol content of less than 70%, and in some examples the polyphenol content is less than 50%. In particular examples, the grape seed extract contains 38-50% polyphenols, 9-12% fiber, 1-2% protein, 25-30% sugars and less than 1% lipid (col. 26, lines 18-25). The topical compositions comprise about 0.001 to about 1.0% of decolorized muscadine pomace solvent extract and about 0.00001% to about 0.1% grape seed extract, with percentages being based upon the total weight of the topical composition (col. 26, lines 26-46).
Fisher teaches antioxidant compositions that include muscadine pomace extract and resveratrol from a source other than muscadine. The compositions increase the expression of antioxidant genes and/or genes associated with mitochondrial biogenesis (abstract). The ratio of muscadine pomace extract polyphenols to trans-resveratrol is in the range of 0.1/1 to 10/1 (weight to weight) (col. 1, lines 8-11). Example 3 demonstrated a strong synergistic effect of the muscadine pomace extract and an additional source of resveratrol, such as Japanese knotweed root extract, as an anti-aging composition in producing lipophilic antioxidant capacity (col. 25, lines 35-39). US’162 specifically teaches a method of improving skin quality by inhibiting or reducing free radical formation or activity in a skin cell by applying a solution or topical ointment containing a muscadine pomace extract either alone or in combination with additional active ingredients, including resveratrol (col. 17-18, lines 65-3).
Faller discloses a method of increasing firmness or elasticity or reducing the appearance of sagginess in the periorbital area of a person's skin, comprising topically applying to the skin in need thereof a composition comprising magnolia extract and Vitis vinifera extract (abstract; claim 1). The magnolia extract can be in the composition from about 0.1% to about 10.0% by weight (col. 4, lines 29-30). The Magnolia bark extract is Magnolia officinalis bark extract (claim 3; col. 7, line 36). Magnolia extract works by reducing the blood flow near the skin surface though a variety of ways (e.g., vasoconstriction, inhibition of angiogenesis, endothelial cell migration, or tube formation in or near the skin area that has been contacted with a composition containing Magnolia extract) (col. 7, lines 43-47).
It would have been prima facie obvious to one of ordinary skill in the art to incorporate the muscadine grape pomace extract of Ianiro1, the resveratrol of Fisher, and the Magnolia officinalis bark extract of Faller, into the composition of US’751, since each are known and routine actives in the art. It would have been obvious to add in the muscadine grape pomace extract of Ianiro1 into the grape seed extract composition of US’751 since both are known and routine actives for improving skin appearance in topical compositions and the combination of muscadine pomace extract and grape seed extract is desirable as taught by Ianiro1. One of ordinary skill in the art would have been motivated to add the resveratrol of Fisher into the topical composition of US’751 since Fisher teaches resveratrol as a known and routine active for improving skin quality and appearance in topical compositions. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Lastly, one of ordinary skill in the art would have been motivated to add Magnolia officinalis bark extract into the composition since it increases firmness and elasticity of a person's skin by reducing the blood flow near the skin surface, as taught by Faller.
Regarding the amounts and ratio of the components in the combined topical composition, one of ordinary skill in the art would have arrived at the instantly claimed amounts and ratios of instant claims 1, 6, and 22 through no more than routine experimentation depending on the desired properties of the final product. Generally, differences in concentration or temperature 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 1, 6, 8-12, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,132,162 in view of Ianiro1, Ianiro2, and Faller (above). The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Ianiro1, Ianiro2, and Faller.
US’162 claims an antioxidant composition, comprising: (a) a muscadine (Vitis rotundifolia) pomace solvent extract and (b) resveratrol from a source other than muscadine, wherein a ratio of muscadine pomace extract polyphenols to trans-resveratrol is in the range of 0.1/1 to 10/1 (weight to weight) (claim 1).
The claims of US’162 differ from the instant claims in that the US’162 claims do not recite the specific decolorized muscadine grape pomace extract or Chardonnay grape seed extract of claims 1, 6, and 22, nor do the US’162 claims define the amount of each ingredient and the ratio as instantly claimed, nor the Magnolia officinalis bark extract of claims 1 and 6.
Ianiro1 discloses a topical composition comprising an effective amount of: (a) a decolorized muscadine grape pomace extract, (b) beta-glucan, and (c) grape seed extract (claim 17; col. 23, lines 43-46). The decolorized muscadine grape pomace extract comprises about 9% to about 10% polyphenols and less than about 4% monosaccharides, and wherein the condensed tannins are less than about 10% of the total polyphenol content of the decolorized muscadine pomace extract (claim 13; col. 3, lines 18-24). The grape seed extract included in the topical compositions may be a Vitis vinifera grape seed extract. In some examples, the grape seed extract has a total polyphenol content of less than 70%, and in some examples the polyphenol content is less than 50%. In particular examples, the grape seed extract contains 38-50% polyphenols, 9-12% fiber, 1-2% protein, 25-30% sugars and less than 1% lipid (col. 26, lines 18-25). The topical compositions comprise about 0.001 to about 1.0% of decolorized muscadine pomace solvent extract and about 0.00001% to about 0.1% grape seed extract, with percentages being based upon the total weight of the topical composition (col. 26, lines 26-46).
Ianiro2 discloses compositions that comprise an isolated or purified Chardonnay seed extract containing 38-50% polyphenols, 9-12% fiber, 1-2% protein, 25-30% sugars and less than 1% lipid (col. 4, lines 31-41). The Chardonnay seed extract is an extract obtained by extracting the Chardonnay seeds only with water, for example by water solvent extraction without the use of alcohol solvents (such as methanol or ethanol solvents), mineral acid solvents (such as sulfuric acid), or resins (col. 5, lines 4-16). Grape seed extract is beneficial in many areas of health because of its antioxidant effect to bond with collagen, promoting youthful skin, cell health, elasticity, and flexibility (col. 7, lines 38-40.
Faller discloses a method of increasing firmness or elasticity or reducing the appearance of sagginess in the periorbital area of a person's skin, comprising topically applying to the skin in need thereof a composition comprising magnolia extract and Vitis vinifera extract (abstract; claim 1). The magnolia extract can be in the composition from about 0.1% to about 10.0% by weight (col. 4, lines 29-30). The Magnolia bark extract is Magnolia officinalis bark extract (claim 3; col. 7, line 36). Magnolia extract works by reducing the blood flow near the skin surface though a variety of ways (e.g., vasoconstriction, inhibition of angiogenesis, endothelial cell migration, or tube formation in or near the skin area that has been contacted with a composition containing Magnolia extract) (col. 7, lines 43-47).
It would have been prima facie obvious to one of ordinary skill in the art to incorporate the muscadine pomace extract of Ianiro1, the Chardonnay grape seed extract of Ianiro2, and the Magnolia officinalis bark extract of Faller, into the composition of US’162, since each are known and routine actives in the art. It would have been obvious to use the muscadine grape pomace extract of Ianiro1 as the muscadine pomace extract in the topical composition of US’162 since it entails no more than simple substitution of one known element for another to give predictable results. It would have also been obvious to add in the Chardonnay grape seed extract of Ianiro2 into the muscadine pomace extract composition of US’162 since both are known and routine actives for improving skin appearance in topical compositions and the combination of muscadine pomace extract and grape seed extract is desirable as taught by Ianiro1. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Lastly, one of ordinary skill in the art would have been motivated to add Magnolia officinalis bark extract into the composition since it increases firmness and elasticity of a person's skin by reducing the blood flow near the skin surface, as taught by Faller.
Regarding the amounts and ratio of the components in the combined topical composition, one of ordinary skill in the art would have arrived at the instantly claimed amounts and ratios of instant claims 1, 6, and 22 through no more than routine experimentation depending on the desired properties of the final product. Generally, differences in concentration or temperature 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 1, 6, 8-12, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-21 and 25-26 of U.S. Patent No. 9,173,916 in view of Ianiro1, Ianiro2, and Faller (above). The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Ianiro1, Ianiro2, and Faller.
US’916 claims a muscadine extract composition comprising (a) a bronze muscadine pomace-only solvent extract and (b) purple muscadine pomace-only solvent extract and purple muscadine whole grape solvent extract, and the muscadine extract has a polyphenol content of at least 2% (claim 20). The composition is provided in a cosmetic composition (claim 21) and further comprises resveratrol from a source other than muscadine pomace (claims 25-26).
The claims of US’916 differ from the instant claims in that the US’916 claims do not recite the specific decolorized muscadine grape pomace extract or Chardonnay grape seed extract of claims 1, 6, and 22, nor do the US’916 claims define the amount of each ingredient and the ratio as instantly claimed, nor the Magnolia officinalis bark extract of claims 1 and 6.
Ianiro1 discloses a topical composition comprising an effective amount of: (a) a decolorized muscadine grape pomace extract, (b) beta-glucan, and (c) grape seed extract (claim 17; col. 23, lines 43-46). The decolorized muscadine grape pomace extract comprises about 9% to about 10% polyphenols and less than about 4% monosaccharides, and wherein the condensed tannins are less than about 10% of the total polyphenol content of the decolorized muscadine pomace extract (claim 13; col. 3, lines 18-24). The grape seed extract included in the topical compositions may be a Vitis vinifera grape seed extract. In some examples, the grape seed extract has a total polyphenol content of less than 70%, and in some examples the polyphenol content is less than 50%. In particular examples, the grape seed extract contains 38-50% polyphenols, 9-12% fiber, 1-2% protein, 25-30% sugars and less than 1% lipid (col. 26, lines 18-25). The topical compositions comprise about 0.001 to about 1.0% of decolorized muscadine pomace solvent extract and about 0.00001% to about 0.1% grape seed extract, with percentages being based upon the total weight of the topical composition (col. 26, lines 26-46).
Ianiro2 discloses compositions that comprise an isolated or purified Chardonnay seed extract containing 38-50% polyphenols, 9-12% fiber, 1-2% protein, 25-30% sugars and less than 1% lipid (col. 4, lines 31-41). The Chardonnay seed extract is an extract obtained by extracting the Chardonnay seeds only with water, for example by water solvent extraction without the use of alcohol solvents (such as methanol or ethanol solvents), mineral acid solvents (such as sulfuric acid), or resins (col. 5, lines 4-16). Grape seed extract is beneficial in many areas of health because of its antioxidant effect to bond with collagen, promoting youthful skin, cell health, elasticity, and flexibility (col. 7, lines 38-40.
Faller discloses a method of increasing firmness or elasticity or reducing the appearance of sagginess in the periorbital area of a person's skin, comprising topically applying to the skin in need thereof a composition comprising magnolia extract and Vitis vinifera extract (abstract; claim 1). The magnolia extract can be in the composition from about 0.1% to about 10.0% by weight (col. 4, lines 29-30). The Magnolia bark extract is Magnolia officinalis bark extract (claim 3; col. 7, line 36). Magnolia extract works by reducing the blood flow near the skin surface though a variety of ways (e.g., vasoconstriction, inhibition of angiogenesis, endothelial cell migration, or tube formation in or near the skin area that has been contacted with a composition containing Magnolia extract) (col. 7, lines 43-47).
It would have been prima facie obvious to one of ordinary skill in the art to incorporate the muscadine pomace extract of Ianiro1, the Chardonnay grape seed extract of Ianiro2, and the Magnolia officinalis bark extract of Faller, into the composition of US’916, since each are known and routine actives in the art. It would have been obvious to use the muscadine grape pomace extract of Ianiro1 as the muscadine pomace extract in the topical composition of US’916 since it entails no more than simple substitution of one known element for another to give predictable results. It would have also been obvious to add in the Chardonnay grape seed extract of Ianiro2 into the muscadine pomace extract composition of US’916 since both are known and routine actives for improving skin appearance in topical compositions and the combination of muscadine pomace extract and grape seed extract is desirable as taught by Ianiro1. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Lastly, one of ordinary skill in the art would have been motivated to add Magnolia officinalis bark extract into the composition since it increases firmness and elasticity of a person's skin by reducing the blood flow near the skin surface, as taught by Faller.
Regarding the amounts and ratio of the components in the combined topical composition, one of ordinary skill in the art would have arrived at the instantly claimed amounts and ratios of instant claims 1, 6, and 22 through no more than routine experimentation depending on the desired properties of the final product. Generally, differences in concentration or temperature 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 1, 6, 8-12, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, 16, and 25 of U.S. Patent No. 8,568,804 in view of Ianiro1, Ianiro2, and Faller (above). The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Ianiro1, Ianiro2, and Faller.
US’804 claims a composition for use as an antioxidant, comprising a muscadine (Vitis rotundifolia) pomace solvent extract, wherein the muscadine pomace solvent extract has a polyphenol content of at least 2%; and resveratrol from a source other than muscadine with a minimum purity of at least 5% trans-resveratrol, wherein a ratio of muscadine pomace extract polyphenols to trans-resveratrol is in the range of 0.1/1 to 10/1 (weight to weight), and wherein the composition has antioxidant activity (claims 1 and 16). The composition may be provided as a topical ointment (claims 10 and 25).
The claims of US’804 differ from the instant claims in that the US’804 claims do not recite the specific decolorized muscadine grape pomace extract or Chardonnay grape seed extract of claims 1, 6, and 22, nor do the US’804 claims define the amount of each ingredient and the ratio as claimed, nor the Magnolia officinalis bark extract of claims 1 and 6.
Ianiro1 discloses a topical composition comprising an effective amount of: (a) a decolorized muscadine grape pomace extract, (b) beta-glucan, and (c) grape seed extract (claim 17; col. 23, lines 43-46). The decolorized muscadine grape pomace extract comprises about 9% to about 10% polyphenols and less than about 4% monosaccharides, and wherein the condensed tannins are less than about 10% of the total polyphenol content of the decolorized muscadine pomace extract (claim 13; col. 3, lines 18-24). The grape seed extract included in the topical compositions may be a Vitis vinifera grape seed extract. In some examples, the grape seed extract has a total polyphenol content of less than 70%, and in some examples the polyphenol content is less than 50%. In particular examples, the grape seed extract contains 38-50% polyphenols, 9-12% fiber, 1-2% protein, 25-30% sugars and less than 1% lipid (col. 26, lines 18-25). The topical compositions comprise about 0.001 to about 1.0% of decolorized muscadine pomace solvent extract and about 0.00001% to about 0.1% grape seed extract, with percentages being based upon the total weight of the topical composition (col. 26, lines 26-46).
Ianiro2 discloses compositions that comprise an isolated or purified Chardonnay seed extract containing 38-50% polyphenols, 9-12% fiber, 1-2% protein, 25-30% sugars and less than 1% lipid (col. 4, lines 31-41). The Chardonnay seed extract is an extract obtained by extracting the Chardonnay seeds only with water, for example by water solvent extraction without the use of alcohol solvents (such as methanol or ethanol solvents), mineral acid solvents (such as sulfuric acid), or resins (col. 5, lines 4-16). Grape seed extract is beneficial in many areas of health because of its antioxidant effect to bond with collagen, promoting youthful skin, cell health, elasticity, and flexibility (col. 7, lines 38-40.
Faller discloses a method of increasing firmness or elasticity or reducing the appearance of sagginess in the periorbital area of a person's skin, comprising topically applying to the skin in need thereof a composition comprising magnolia extract and Vitis vinifera extract (abstract; claim 1). The magnolia extract can be in the composition from about 0.1% to about 10.0% by weight (col. 4, lines 29-30). The Magnolia bark extract is Magnolia officinalis bark extract (claim 3; col. 7, line 36). Magnolia extract works by reducing the blood flow near the skin surface though a variety of ways (e.g., vasoconstriction, inhibition of angiogenesis, endothelial cell migration, or tube formation in or near the skin area that has been contacted with a composition containing Magnolia extract) (col. 7, lines 43-47).
It would have been prima facie obvious to one of ordinary skill in the art to incorporate the muscadine pomace extract of Ianiro1, the Chardonnay grape seed extract of Ianiro2, and the Magnolia officinalis bark extract of Faller, into the composition of US’804, since each are known and routine actives in the art. It would have been obvious to use the muscadine grape pomace extract of Ianiro1 as the muscadine pomace extract in the topical composition of US’804 since it entails no more than simple substitution of one known element for another to give predictable results. It would have also been obvious to add in the Chardonnay grape seed extract of Ianiro2 into the muscadine pomace extract composition of US’804 since both are known and routine actives for improving skin appearance in topical compositions and the combination of muscadine pomace extract and grape seed extract is desirable as taught by Ianiro1. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Lastly, one of ordinary skill in the art would have been motivated to add Magnolia officinalis bark extract into the composition since it increases firmness and elasticity of a person's skin by reducing the blood flow near the skin surface, as taught by Faller.
Regarding the amounts and ratio of the components in the combined topical composition, one of ordinary skill in the art would have arrived at the instantly claimed amounts and ratios of instant claims 1, 6, and 22 through no more than routine experimentation depending on the desired properties of the final product. Generally, differences in concentration or temperature 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 1, 6, 8-12, and 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 7, 9, 12, and 14 of U.S. Patent No. 9,421,189 in view of Ianiro1, Ianiro2, and Faller (above). The Obviousness Double Patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims and would have been obvious over the reference claims in view of Ianiro1, Ianiro2, and Faller.
US’189 claims a muscadine pomace extract composition with a polyphenol content of at least 2% (claims 1 and 9). The composition may be a cosmetic composition (claims 5 and 12) which further comprises resveratrol from a source other than muscadine pomace (claims 7 and 14).
The claims of US’189 differ from the instant claims in that the US’189 claims do not claim the specific decolorized muscadine grape pomace extract or Chardonnay grape seed extract of claims 1, 6, and 22, nor do the US’189 claims define the amount of each ingredient and the ratio as instantly claimed, nor the Magnolia officinalis bark extract of claims 1 and 6.
Ianiro1 discloses a topical composition comprising an effective amount of: (a) a decolorized muscadine grape pomace extract, (b) beta-glucan, and (c) grape seed extract (claim 17; col. 23, lines 43-46). The decolorized muscadine grape pomace extract comprises about 9% to about 10% polyphenols and less than about 4% monosaccharides, and wherein the condensed tannins are less than about 10% of the total polyphenol content of the decolorized muscadine pomace extract (claim 13; col. 3, lines 18-24). The grape seed extract included in the topical compositions may be a Vitis vinifera grape seed extract. In some examples, the grape seed extract has a total polyphenol content of less than 70%, and in some examples the polyphenol content is less than 50%. In particular examples, the grape seed extract contains 38-50% polyphenols, 9-12% fiber, 1-2% protein, 25-30% sugars and less than 1% lipid (col. 26, lines 18-25). The topical compositions comprise about 0.001 to about 1.0% of decolorized muscadine pomace solvent extract and about 0.00001% to about 0.1% grape seed extract, with percentages being based upon the total weight of the topical composition (col. 26, lines 26-46).
Ianiro2 discloses compositions that comprise an isolated or purified Chardonnay seed extract containing 38-50% polyphenols, 9-12% fiber, 1-2% protein, 25-30% sugars and less than 1% lipid (col. 4, lines 31-41). The Chardonnay seed extract is an extract obtained by extracting the Chardonnay seeds only with water, for example by water solvent extraction without the use of alcohol solvents (such as methanol or ethanol solvents), mineral acid solvents (such as sulfuric acid), or resins (col. 5, lines 4-16). Grape seed extract is beneficial in many areas of health because of its antioxidant effect to bond with collagen, promoting youthful skin, cell health, elasticity, and flexibility (col. 7, lines 38-40.
Faller discloses a method of increasing firmness or elasticity or reducing the appearance of sagginess in the periorbital area of a person's skin, comprising topically applying to the skin in need thereof a composition comprising magnolia extract and Vitis vinifera extract (abstract; claim 1). The magnolia extract can be in the composition from about 0.1% to about 10.0% by weight (col. 4, lines 29-30). The Magnolia bark extract is Magnolia officinalis bark extract (claim 3; col. 7, line 36). Magnolia extract works by reducing the blood flow near the skin surface though a variety of ways (e.g., vasoconstriction, inhibition of angiogenesis, endothelial cell migration, or tube formation in or near the skin area that has been contacted with a composition containing Magnolia extract) (col. 7, lines 43-47).
It would have been prima facie obvious to one of ordinary skill in the art to incorporate the muscadine pomace extract of Ianiro1, the Chardonnay grape seed extract of Ianiro2, and the Magnolia officinalis bark extract of Faller, into the composition of US’189, since each are known and routine actives in the art. It would have been obvious to use the muscadine grape pomace extract of Ianiro1 as the muscadine pomace extract in the topical composition of US’189 since it entails no more than simple substitution of one known element for another to give predictable results. It would have also been obvious to add in the Chardonnay grape seed extract of Ianiro2 into the muscadine pomace extract composition of US’189 since both are known and routine actives for improving skin appearance in topical compositions and the combination of muscadine pomace extract and grape seed extract is desirable as taught by Ianiro1. “It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose…[T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Lastly, one of ordinary skill in the art would have been motivated to add Magnolia officinalis bark extract into the composition since it increases firmness and elasticity of a person's skin by reducing the blood flow near the skin surface, as taught by Faller.
Regarding the amounts and ratio of the components in the combined topical composition, one of ordinary skill in the art would have arrived at the instantly claimed amounts and ratios of instant claims 1, 6, and 22 through no more than routine experimentation depending on the desired properties of the final product. Generally, differences in concentration or temperature 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant's arguments filed 07/23/2026 have been fully considered but they are not persuasive:
(1) Applicant argues that the prima facie case is not met since the references fail to teach or suggest all the elements of the claims, specifically a topical composition including a Magnolia officinalis bark extract (p. 6 of Remarks).
Such an argument is unpersuasive in view of the newly applied reference, Faller, which discloses a topical composition including a Magnolia officinalis bark extract. See the obviousness reasoning above.
(2) In regards to claim 22, Applicant argues that the synergistic effect reported in Table 18 of the specification illustrates an unexpected superior effect when the three claimed elements (i.e., muscadine grape pomace extract, water extract of Chardonnay grape seed, and resveratrol) are present as compared to each of them alone (p. 7 of Remarks).
In response to this argument, it is noted that a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586. See MPEP 716.02(a). The instantly relied on primary reference (Ianiro1 or US’034) provides experimental data regarding the elastase and collagenase inhibition provided by the same decolorized muscadine grape pomace extract as claimed. The methods of determining elastase and collagenase inhibition appear to be identical in the Ianiro1 disclosure and the instant specification (col. 20-21, lines 58-25 of Ianiro1; p. 53-54 of instant specification). Applicant points to Table 18 of the instant specification which shows an “actual” inhibition of 60% for elastase and 48% for collagenase. However, the elastase and collagenase inhibition of 0.1% muscadine pomace extract alone in Fig. 5 and 6 of Ianiro1 is 74% and 37%, respectively. Since the muscadine grape pomace extracts of Ianrio1 and the claims are identical and the inhibition assay methods are also identical, the data of Ianiro1 therefore indicates that the composition made obvious above would at the very least demonstrate an elastase inhibition of 74% and a collagenase inhibition of 37% solely from the presence of the 0.1% muscadine pomace extract. Such values are close, if not higher, than the “actual” inhibition demonstrated by the blends of Table 18. As such, the results of Table 18 do not appear to be greater than those which would have been expected from the prior art to an unobvious and statistically significant extent. Additionally, it is unclear how the results of Ianiro1 (74% elastase inhibition and 37% collagenase inhibition by 0.1% muscadine alone) are so different than the -1% elastase inhibition and 9% collagenase inhibition by 0.1% muscadine alone as presented in Tables 10 and 11 of the instant specification, and which are used to derive the “expected” values of Table 18, unless the muscadine pomace extracts or assay methods are different. Lastly, Fisher explicitly teaches an observed synergy when resveratrol is combined with the same muscadine pomace extract as taught by Ianiro1 and the instant claims (See col. 9, claim 58-60 of Fisher), which further indicates that synergy is not completely unexpected.
(3) Applicant argues against the double patenting rejections for similar reasons as discussed above (p. 7-9 of Remarks).
The above responses also apply to the double patenting rejections.
Conclusion
No claims allowed.
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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1616
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