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 .
Status of Claims
Receipt of Remarks/Amendments filed on 01/28/2026 is acknowledged. Claims 1, 6, 8-10, 14-15, 19-20 are amended and claims 2-5, 7, and 16 are canceled. Claims 13-15 and 17-20 remain withdrawn as being directed to a non-elected invention. Claims 1, 6, and 8-12 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.
The following rejections are maintained from the office action of 10/28/2025:
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, and 8-12 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 US’034, in view of Ianiro, T., et al. (US 10709751 B2, 07/14/2020, IDS dated 07/27/2023), hereinafter US’751, and Fisher, L., et al. (US 9132162 B2, 09/15/2015, IDS dated 07/27/2023), hereinafter US’162, as evidenced by the Missouri Botanical Garden, Vitis vinifera ‘Chardonnay’, Retrieved 10/23/2025 (on record), hereinafter Missouri Botanical Garden.
US’034 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), which reads on the decolorized muscadine grape pomace extract of instant claims 1 and 6.
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 grape seed extract is provided with glycerin/water, therefore reading on a water extract (table 5). Chardonnay grapes as instantly claimed are of the species Vitis vinifera, as evidenced by the Missouri Botanical Garden. Thus, it is believed that the grape seed extract of US’034 is identical to the Chardonnay grape seed extract as defined in instant claims 1 and 6.
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). The instantly claimed amount of muscadine extract as recited in claim 1 (i.e., 0.10%) falls within the range of muscadine extract taught by US’034. Similarly, the instantly claimed amount of grape seed extract as recited in claim 1 (i.e., 0.025%) falls within the range of grape seed extract taught by US’034. 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.
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 compositions are 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). The skin care compositions can be 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). As such, the skin care/topical composition of US’034 reads on a cosmetic topical composition as defined in claim 8. 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 serum and lotion of claims 9-10. 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 also 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 a vitamin as recited in claim 11.
US’034 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 with a minimum purity of at least 5%, wherein a ratio of muscadine polyphenols to trans-resveratrol is in the range of 0.1/1 to 10/1 (weight to weight). The muscadine pomace extract and trans-resveratrol mixture possesses antioxidant activity (col. 13, lines 24-44).
The teachings of US’034 differ from that of the instant invention in that US’034 does not explicitly teach a topical composition comprising resveratrol in combination with both grape extracts. Additionally, it is assumed above that the grape seed extract of US’034 is the same as the Chardonnay grape seed extract of the instant claims, however, in the case that it is not, US’034 does not explicitly teach wherein the grape seed extract is from Chardonnay grapes.
US’751 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).
As discussed above, US’034 discloses prior work which teaches the combination of a muscadine pomace extract and trans-resveratrol. Reference is made to US’162 which 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). 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, such as cross-linking agents. 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). 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).
First, it would have been obvious to combine the teachings of US’034 and US’751 before the effective filing date of the claimed invention by using the water extract of Chardonnay grape seeds taught by US’751 as the grape seed extract of US’034 to yield the instantly claimed invention. It would have been prima facie obvious to use the water extract of Chardonnay grape seeds taught by US’751 as the grape seed extract of US’034 since it is no more than simple substitution of one known element for another to yield predictable results. See MPEP 2143. Additionally, grape seed extracts such as the one of US’751 comprise 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 US’034 and the Chardonnay seed extract of US’751 comprise the same dry weight percentages of polyphenols, fiber, protein, lipids, and sugars. Furthermore, the grape seed extract of US’034 is from a Vitis vinifera grape which includes Chardonnay grapes.
It would have been further obvious to modify the combined composition of US’034 and US’751 with the teachings of US’162 before the effective filing date of the claimed invention by adding the resveratrol of US’162 to the combined composition above to yield the instantly claimed invention. One of ordinary skill in the art would have been motivated to add the resveratrol of US’162 into the combined topical composition above since resveratrol and muscadine pomace extract are known to have strong synergistic effects in terms of antioxidant activity and anti-aging, both of which are desirable in skin care compositions. US’162 further teaches the combination of resveratrol and muscadine pomace extract in topical compositions for improving skin quality. Likewise, US’034 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 US’162 into the combined topical composition of US’034 and US’751 since US’034 welcomes additional active ingredients.
It would have been obvious to maintain the amounts of muscadine grape pomace extract and grape seed extract as discussed above in the combined composition of US’034, US’751, and US’162 since these are known and effective amounts of such extracts in a topical composition for improving skin health and appearance. Such amounts yield the instantly claimed amounts of muscadine extract and Chardonnay grape seed extract as recited in claim 1 obvious, as discussed above.
Regarding the amount of resveratrol in the combined topical composition, US’162 teaches a ratio of muscadine pomace extract polyphenols to trans-resveratrol is in the range of 0.1/1 to 10/1. Thus, one of ordinary skill in the art would have followed the guidance of US’162 to adjust the amount of resveratrol in the combined composition depending on the amount of muscadine pomace extract polyphenols already present. 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 in claims 1 (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 defined in claim 6, the combined topical composition comprises varying amounts of each ingredient: muscadine extract, grape seed extract, and resveratrol. Furthermore, US’162 teaches a preferred ratio of muscadine extract to resveratrol. While there is no explicit teaching of a three-part ratio, such a ratio is easily adjusted by changing the amounts of each ingredient. Thus, one of ordinary skill in the art would have arrived at the instantly claimed ratio of claim 6 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).
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.
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, and 8-12 re 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 US’751 and US’162. 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 US’751 and US’162.
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 claim the Chardonnay grape seed extract or resveratrol of claims 1 and 6 nor do the US’034 claims define the amount of each ingredient and the ratio as defined in claims 1 and 6, respectively.
US’751 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).
US’162 which 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).
It would have been obvious to combined the teachings of US’034, US’751, and US’162 to give a topical composition containing muscadine grape pomace extract, water extract of Chardonnay grape seed, and resveratrol as instantly claimed. It would have been obvious to use the water extract of Chardonnay grape seed as taught by US’751 as the grape seed extract in the topical composition of US’034 since this is no more than simple substitution of one known element for another to give predictable results. It would have been further obvious to add the resveratrol of US’162 to the topical composition of US’034 since US’162 teaches a strong synergistic effect between muscadine pomace extract and an additional source of resveratrol, which leads to a benefit in skin quality.
Regarding the amounts and ratio of the components in the combined topical composition above, one of ordinary skill in the art would have arrived at the instantly claimed amounts and ratios of instant claims 1 and 6 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, and 8-12 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 US’034 and US’162. 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 US’034 and US’162.
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 claim the decolorized muscadine grape pomace extract or resveratrol of claims 1 and 6 nor do the US’751 claims define the amount of each ingredient and the ratio as defined in claims 1 and 6, respectively.
US’034 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).
US’162 which 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).
It would have been obvious to combined the teachings of US’751, US’034, and US’162 to give a topical composition containing muscadine grape pomace extract, water extract of Chardonnay grape seed, and resveratrol as instantly claimed. It would have been obvious combine the compositions of US’751 and US’034 to give a topical composition as taught by US’034 which comprises the muscadine extract of US’034 and the water extract of Chardonnay grape seed of US’751 since both references teach compositions comprising grape seed extracts with the same make-up. Generally, it is considered prima facie obvious to combine prior art elements according to known methods to yield predictable results. See MPEP 2143. It would have been further obvious to add the resveratrol of US’162 to the combined topical composition since US’162 teaches a strong synergistic effect between muscadine pomace extract and an additional source of resveratrol, which leads to a benefit in skin quality.
Regarding the amounts and ratio of the components in the combined topical composition above, one of ordinary skill in the art would have arrived at the instantly claimed amounts and ratios of instant claims 1 and 6 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, and 8-12 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 US’034 and US’751. 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 US’034 and US’751.
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 claim the specific decolorized muscadine grape pomace extract or Chardonnay grape seed extract of claims 1 and 6 nor do the US’162 claims define the amount of each ingredient and the ratio as defined in claims 1 and 6, respectively.
US’034 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).
US’751 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.
It would have been obvious to combined the teachings of US’162, US’034, and US’751 to give a topical composition containing muscadine grape pomace extract, water extract of Chardonnay grape seed, and resveratrol as instantly claimed. It would have been obvious combine the compositions of US’162 and US’034 to give a topical composition comprising the muscadine pomace extract of US’034 and the resveratrol of US’162 since both references teach compositions comprising muscadine grape pomace extract. Generally, it is considered prima facie obvious to combine prior art elements according to known methods to yield predictable results. See MPEP 2143. It would have been further obvious to add the water extract of Chardonnay grape seed to the combined topical composition since US’751 teaches that grape seed is beneficial in promoting skin health and quality.
Regarding the amounts and ratio of the components in the combined topical composition above, one of ordinary skill in the art would have arrived at the instantly claimed amounts and ratios of instant claims 1 and 6 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, and 8-12 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 US’034 and US’751. 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 US’034 and US’751.
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 claim the specific decolorized muscadine grape pomace extract or Chardonnay grape seed extract of claims 1 and 6 nor do the US’916 claims define the amount of each ingredient and the ratio as defined in claims 1 and 6, respectively.
US’034 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).
US’751 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.
It would have been obvious to combined the teachings of US’916, US’034, and US’751 to give a topical composition containing muscadine grape pomace extract, water extract of Chardonnay grape seed, and resveratrol as instantly claimed. It would have been obvious to combine the compositions of US’916 and US’034 to give a topical composition comprising the muscadine pomace extract of US’034 and the resveratrol of US’916 since both references teach compositions comprising muscadine grape pomace extract for cosmetic use. Generally, it is considered prima facie obvious to combine prior art elements according to known methods to yield predictable results. See MPEP 2143. It would have been further obvious to add the water extract of Chardonnay grape seed to the combined topical composition since US’751 teaches that grape seed is beneficial in promoting skin health and quality.
Regarding the amounts and ratio of the components in the combined topical composition above, one of ordinary skill in the art would have arrived at the instantly claimed amounts and ratios of instant claims 1 and 6 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, and 8-12 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 US’034 and US’751. 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 US’034 and US’751.
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 claim the specific decolorized muscadine grape pomace extract or Chardonnay grape seed extract of claims 1 and 6 nor do the US’804 claims define the amount of each ingredient and the ratio as defined in claims 1 and 6, respectively.
US’034 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).
US’751 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.
It would have been obvious to combined the teachings of US’804, US’034, and US’751 to give a topical composition containing muscadine grape pomace extract, water extract of Chardonnay grape seed, and resveratrol as instantly claimed. It would have been obvious to combine the compositions of US’804 and US’034 to give a topical composition comprising the muscadine pomace extract of US’034 and the resveratrol of US’804 since both references teach topical compositions comprising muscadine grape pomace extract. Generally, it is considered prima facie obvious to combine prior art elements according to known methods to yield predictable results. See MPEP 2143. It would have been further obvious to add the water extract of Chardonnay grape seed to the combined topical composition since US’751 teaches that grape seed is beneficial in promoting skin health and quality.
Regarding the amounts and ratio of the components in the combined topical composition above, one of ordinary skill in the art would have arrived at the instantly claimed amounts and ratios of instant claims 1 and 6 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, and 8-12 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 US’034 and US’751. 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 US’034 and US’751.
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 and 6 nor do the US’189 claims define the amount of each ingredient and the ratio as defined in claims 1 and 6, respectively.
US’034 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).
US’751 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.
It would have been obvious to combined the teachings of US’189, US’034, and US’751 to give a topical composition containing muscadine grape pomace extract, water extract of Chardonnay grape seed, and resveratrol as instantly claimed. It would have been obvious to combine the compositions of US’189 and US’034 to give a topical composition comprising the muscadine pomace extract of US’034 and the resveratrol of US’189 since both references teach topical compositions comprising muscadine grape pomace extract. Generally, it is considered prima facie obvious to combine prior art elements according to known methods to yield predictable results. See MPEP 2143. It would have been further obvious to add the water extract of Chardonnay grape seed to the combined topical composition since US’751 teaches that grape seed is beneficial in promoting skin health and quality.
Regarding the amounts and ratio of the components in the combined topical composition above, one of ordinary skill in the art would have arrived at the instantly claimed amounts and ratios of instant claims 1 and 6 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 01/28/2026 have been fully considered but they are not persuasive:
Applicant argues that the prima facie case is overcome by a showing of superior, unexpected results of the instantly claimed invention over the prior art. Applicant points to Extract Blend A of the instant invention, which possess a significant improvement and surprising synergy as compared to topical compositions comprising each ingredient individually (i.e., muscadine extract, seed extract, and resveratrol) as well as blends with different ratios (i.e., Blend B and Low Blend).
In response to applicant’s argument of unexpected results, an affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. See In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). In this case, applicant has not provided a comparison to the closest prior art to sufficiently show unexpected results. The closest prior art, as discussed above, is the topical composition of US’034 which comprises both the instantly claimed decolorized muscadine grape pomace extract and grape seed extract at amounts that overlap with the instantly claimed amounts. Thus, a comparison with the closest prior art would need to compare a composition comprising the two grape extracts together, as taught by US’034, with a composition of the instant invention in order to show unexpected results/synergy resulting from the addition of the resveratrol. Based on the data provided by the instant specification, the examiner has no way of knowing if the unexpected results/synergy are directly related to the addition of the resveratrol or if such results are inherent to the combination of the two grape extracts, as taught by the prior art.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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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/SUSANNAH S ARMSTRONG/Examiner, Art Unit 1616
/Mina Haghighatian/Primary Examiner, Art Unit 1616
Prosecution Insights