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 .
Claims 1-10 and 12-15 are pending in the application.
Election/Restrictions
Applicant’s election of Group I, claims 1-8 and 12-15, in the reply filed on July 31, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 9-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 31, 2026.
Claims 1-10 and 12-15 are pending in the application. Claims 9-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Claims 1-8 and 12-15 will presently be examined to the extent they read on the elected subject matter of record.
Priority
This application is a National Stage Entry of PCT/EP2023/051627 filed January 24, 2023, which claims benefit to Italian Foreign Application No. 102022000001190 filed January 25, 2022.
Information Disclosure Statement
Receipt of Information Disclosure Statement filed July 26, 2024 is acknowledged.
Claim Objections
Claims 1, 3, 6, 8, 12, and 14 are objected to because of the following informalities:
The term “xanthan” is misspelled in claims 1, 3, 12, and 14. It is spelled “xantham”. It should be spelled “xanthan”. Appropriate correction is required.
Claim 6 a missing article before the term “method” in claim 6. The claim should recite “A method of preventing skin diseases…and preventing said skin diseases”. Appropriate correction is required.
Claim 8 is missing a preposition between the terms “prevention” and “damage” in line 2 of the claim. The claim should recite “for the prevention of damage from oxidative stress. Appropriate correction is required.
Claim 14 is missing a preposition between the term “ranging” and “1%”, in line 2 of the claim. The claim should recite “ranging from 1% to 2% by weight”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6-8 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The factors considered in the Written Description requirement are (1) level of skill and knowledge in the art, (2) partial structure, (3) physical and/or chemical properties, (4) functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the (5) method of making the claimed invention.
While all of the factors have been considered, only those required for a prima facie case are set forth below.
The claims are drawn to: A method of preventing skin diseases in a subject in need thereof with the composition according to claim 1, said method comprising applying to said subject a pharmaceutically effective amount of said composition and preventing said skin diseases. Applicant claims the skin disease is a form of skin cancer. Applicant claims a method for the prevention of damage from oxidative stress due to sun exposure of an individual in need thereof with the composition according to claim 3, said method comprising: applying a pharmaceutical effective amount of the composition according to claim 3 to said individual.
Level of skill and knowledge in the art: The relative level of skill possessed by one of ordinary skill in the art of pharmaceutical formulation and synthesis is relatively high, as a majority of lead investigators directing scientific research and development in this particular technological area possess an Ph.D. in a scientific discipline such as organic synthetic chemistry, polymer chemistry, biochemistry, pharmacology, biology or the like.
Applicant does not have sufficient written description for “preventing” skin diseases or “preventing” damage from oxidative stress due to sun exposure.
Vas-Cath Inc. V. Mahurka, 19 USPQ2d 1111, states that applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention, for purposes of the written description inquiry, is whatever is now claimed (see page 1117). A review of the language of the claim indicates that these claims are drawn to prevention of skin diseases or prevention of damage from oxidative stress due to sun exposure with a gel composition for topical use comprising xantham gum, a glyceric extract of pomace Vitis vinifera from Nero di Troia vine and pharmaceutically acceptable excipients, as claimed.
The specification discloses in Example 3 a test for the prevention of oxidative stress due to sun exposure. The efficacy of the composition obtained in Example 2 or in comparison with other compositions containing other Vitis vinifera pomace extracts were evaluated by carrying out one or more of the following tests/assays. The Table on pages 7 and 8 provide the list of the tests/assays, including screening agents for melanoma prevention. However, there is no data demonstrating the composition treats or prevents melanoma, which is a skin disease. Example 4 tests the effect of GExtract NdT on the cellular viability: in vitro study with the HaCaT cells. GExtract NdT did not lead to a statistically significant viability reduction in HaCaT cells exposed for 24 hours to a concentration of 2% v/v. This test does not demonstrate prevention of skin diseases or prevention of damage from oxidative stress due to sun exposure. Based on the data in Example 5, the results indicate that pre-treating cells with GExtract NdT at 2% v/v concentration resulted to be protective against both the stimuli. The results of the exposure to menadione after pre-treatment with GExtract NdT are reported in Table 2. GExtract NdT led to a statistically significant reduction in levels of reactive oxygen species (ROS) after 24 hours for treatment with the non-cytotoxic concentration tested in menadione-stimulated human keratinocytes. In light of what emerged in the experimental conditions, the antioxidant activity of GExtract NdT is confirmed. This data does not demonstrate skin diseases or damage from oxidative stress due to sun exposure is prevented. Based on the data, Applicant was not in possession of compositions that “prevent” skin diseases or “prevent" damage from oxidative stress due to sun exposure.
Weighing all the factors, the breadth of the claims reading on antibiotics yet to be discovered, the lack of correlation between structure and function of the antibiotics, level of knowledge and skill in the art, one of ordinary skill in the art would not recognize from the disclosure that the applicant was in possession of the genus of antibiotics and prevention of acne.
The written description requirement is not satisfied.
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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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, and 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Choisy et al. English Translation (FR 3096582) in view of Suriano Publication (2011, 17th International Symposium GiESCO). Choisy et al. cited by Applicant on the IDS dated July 24, 2026.
Applicant’s Invention
Applicant claims a gel composition for topical use comprising xantham gum, a glyceric extract of pomace Vitis vinifera from Nero di Troia vine and pharmaceutically acceptable excipients. Applicant claims a method of preventing skin diseases in a subject in need thereof with the composition according to claim 1, said method comprising applying to said subject a pharmaceutically effective amount of said composition and preventing said skin diseases. Applicant claims a method for the prevention damage from oxidative stress due to sun exposure of an individual in need thereof with the composition according to claim 3, said method comprising applying a pharmaceutical effective amount of the composition according to claim 3 to said individual.
Determination of the scope of the content of the prior art
(MPEP 2141.01)
Choisy et al. teach the aqueous extract of Château d'Yquem grape marc obtained by extraction with subcritical water, is advantageous for topical applications on keratin materials in the anti-aging field, in particular to promote and/or improve the formation of the stratum corneum, promote and/or improve the development of the extracellular matrix, promote and/or improve epidermal renewal, promote and/or improve skin revitalization, and/or prevent and/or reduce the signs of skin aging (page 2, paragraph [0007], translation).
Choisy et al. teach the aqueous extract of Château d'Yquem grape marc is obtained according to the following steps:
harvest at Château d'Yquem
grape pressing
pomace recovery
freezing
freeze-drying
grinding
extraction using a polar solvent, in particular subcritical water extraction,
addition of a stabilizer, in particular consisting of 80% glycerin (80 glycerin/20 water); And
obtaining the aqueous extract of Château d'Yquem grape marc according to the invention.
Thus, the present invention also relates to an aqueous extract of Château d'Yquem grape marc, obtained by extraction using an aqueous or hydroalcoholic solvent, in particular obtained by extraction with subcritical water (pages 7-8, paragraph [0054], translation).
Regarding claims 1 and 12, Choisy et al. teach a composition comprises:
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(page 29, paragraph [0194], translation).
Regarding claim 1, Choisy et al. teach the compositions can have all cosmetic forms, and in particular be in the form of gels and suitable for application to the skin, the lips and/or the appendages (page 12, paragraph [0085], translation). Choisy et al. teach a cosmetic composition for topical application to keratin materials comprising, in a physiologically acceptable medium, at least one aqueous extract of grape marc from Château d'Yquem, in particular obtained by extraction with subcritical water, such than previously described (page 12, paragraph [0084], translation).
Regarding claim 2, Choisy et al. teach the aqueous extract of Château d'Yquem grape marc is present in the composition in a content ranging from 0.001% to 10% (page 14, paragraph [0101], translation).
Regarding claim 4, Choisy et al. teach the composition comprises any additional ingredient usually used in cosmetics, such as UV filters (page 14, paragraph [0103], translation).
Regarding claim 6, Choisy et al. teach the use of an aqueous extract of Château d'Yquem grape marc, in particular obtained by extraction with subcritical water, as a cosmetic active ingredient intended to promote and/or improve the regeneration of the skin, to promote and/or improve the junction dermo-epidermal, promote and/or improve the formation of the stratum corneum, promote and/or improve the development of the extracellular matrix, promote and/or improve epidermal renewal, promote and/or improve skin revitalization, and/or prevent and/or reduce the signs of skin aging (pages 1-2 of claims, claim 4, translation).
Regarding claim 8, Choisy et al. teach the composition is applied to skin showing signs of aging and/or skin exposed to stress, in particular oxidative stress (page 4, paragraph [0030], translation).
Choisy et al. teach it may also comprise hydrophilic gelling agents, antioxidants, preservatives and mixtures thereof (page 13, paragraph [0094], translation).
Regarding claim 12, Choisy et al. teach the composition is prepared according to the protocol in paragraphs [0196]-[0201] of the translation. The gelling agents, including xanthan gum, are dispersed in turbulent stirring, the aqueous phase is heated, and other ingredients are added, grape marc extract is added and the whole is emulsified with vigorous stirring.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Choisy et al. do not specifically disclose the glyceric extract of Vitis vinifera from the Nero di Troia vine; the sunscreens are present in sufficient quantity to achieve a SPF 50 protection, as claimed in claim 5; the glyceric extract is present in amounts from 20% to 50% by weight; or the xantham gum is present in an amount ranging from 1% to 2% by weight. It is for this reason the Suriano Publication is added as a secondary reference.
Suriano et al. teach during the 2009 vintage a survey was conducted on flavonoids and stilbenic content of three wine red grape varieties, such as a specific biotype of Nero di Troia with small-berry. Nero di Troia have showed the greater content in flavonols, such as myricetin, quercetin, and kaempferol, in total polyphenols and proanthocyanidins, while Susumaniello have the highest total anthocyans content (page 1, Summary).
Finding a prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to combine the teachings of Choisy et al. and Suriano et al. and use the glyceric extract of Vitis vinifera from the Nero di Troia vine in the composition. Choisy et al. teach compositions comprising the aqueous extract of Château d'Yquem grape marc. The aqueous extract of Château d'Yquem grape marc is a glyceric extract because in making the extract a stabilizer, in particular consisting of 80% glycerin (80 glycerin/20 water) is added, obtaining the aqueous extract of Château d'Yquem grape marc. One of ordinary skill in the art would have found it obvious that the combined extraction step and stabilization steps are equivalent to the extraction step of the instant claim, a glyceric extract, and therefore read on extraction with glycerin. Furthermore, the composition in Table 8 comprises xantham gum and other pharmaceutically acceptable excipients. Choisy et al. teach that compositions are used to promote and/or improve the regeneration of the skin, to promote and/or improve the junction dermo-epidermal, promote and/or improve the formation of the stratum corneum, promote and/or improve the development of the extracellular matrix, promote and/or improve epidermal renewal, promote and/or improve skin revitalization, and/or prevent and/or reduce the signs of skin aging. Suriano et al. teach that Nero di Troia showed greater content in flavonols such as myricetin, quercetin, and kaempferol, in total polyphenols and proanthocyanidins. One of ordinary skill in the art would have been motivated to try a different grape cultivar in the compositions taught by Choisy et al. particularly one that has a high flavonol content, such as grapes from Nero di Troia, without evidence to the contrary.
Regarding the limitation that the sunscreens are present in sufficient quantity to achieve a SPF 50 protection, one of ordinary skill in the art would have used experimentation and optimization to achieve a best SPF 50 protection. Choisy et al. teach that additional ingredients usually used in cosmetics, such as UV filters, are added to the composition. Since UV filters, sunscreens, are used in the compositions, one of ordinary skill in the art would have found it obvious to adjust the amount of UV filters in the composition to optimize the SPF protection. The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Regarding claim 13, one of ordinary skill in the art would have used experimentation and optimization to determine the amount of glyceric extract in the composition. Choisy et al. teach the aqueous extract of Château d'Yquem grape marc is present in the composition in a content ranging from 0.001% to 10%. It would have been obvious to one of ordinary skill in the art to adjust the glyceric extract to 20% to 50% by weight to formulate an effective composition. The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Regarding claims 3 and 14, one of ordinary skill in the art would have used experimentation and optimization to determine the amount of xantham gum in the composition. Choisy et al. teach that additional ingredients are present in the composition in a content ranging from 0.01 to 5% by weight relative to the total weight of the composition. In the composition in Table 8, xantham gum is 0.264% of the composition. One of ordinary skill in the art would have been motivated to adjust the amount of xantham gum to any amount within the ranges 0.01 to 5% taught in the prior art, including 0.5% to 4% by weight or 1% to 2% by weight, with a reasonable expectation of success. The adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results.
Therefore, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claims 7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Choisy et al. English Translation (FR 3096582) in view of the Suriano Publication (2011, 17th International Symposium GiESCO) as applied to claims 1-6, 8, and 12-13 above, and further in view of the Katiyar Publication (2008, Mol Nutr Food Res, Katiyar) and the Kaur Publication (2009, The Journal of Nutrition, Kaur et al.).
Applicant’s Invention
Applicant claims a gel composition for topical use comprising xantham gum, a glyceric extract of pomace Vitis vinifera from Nero di Troia vine and pharmaceutically acceptable excipients. Applicant claims a method of preventing skin diseases in a subject in need thereof with the composition according to claim 1, said method comprising applying to said subject a pharmaceutically effective amount of said composition and preventing said skin diseases. Applicant claims a method for the prevention damage from oxidative stress due to sun exposure of an individual in need thereof with the composition according to claim 3, said method comprising applying a pharmaceutical effective amount of the composition according to claim 3 to said individual. Applicant claims the skin disease is a form of skin cancer and the skin disease is melanoma.
Determination of the scope of the content of the prior art
(MPEP 2141.01)
The teachings of Choisy et al. and the Suriano Publication with respect to the 35 U.S.C. 103 rejection is hereby incorporated and are therefore applied in the instant rejection as discussed above.
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
Choisy et al. and the Suriano Publication do not specifically disclose the skin disease is a form of skin cancer or the skin disease is melanoma. It is for this reason the Katiyar Publication and the Kaur Publication are added as secondary references.
Katiyar teaches overexposure of the skin to ultraviolet (UV) radiation has a variety of adverse effects on human health, including the development of skin cancers. The proanthocyanidins present in grape seeds (Vitis vinifera) have been shown to have some biological effects, including prevention of photocarcinogensis. The present communication discusses the in vitro and in vivo studies of the possible protective effect of grape seed proanthocyanidins (GSPs). Katiyar teaches it is suggested that the chemopreventative effects of dietary GSPs are mediated through the attenuation of UV-induced: (a) oxidative stress; (b) activation of mitogen-activated protein kinases…and (c) immunosuppression through alterations in immunoregulatory cytokines. Collectively, these studies indicate protective potential of GSPs against experimental photocarcinogensis in SKH-1 hairless mice, and the possible mechanisms of action of GSPs, and suggest that dietary GSPs could be useful in the attenuation of the adverse UV-induced health effects in human skin (page 1, Abstract). Katiyar teaches that data indicated that dietary GSPs may have the ability to inhibit UVB induced transformation of benign papillomas to carcinomas (page 3, paragraph 3).
Kaur et al. teach the review focuses on recent advancements in cancer chemopreventive and anticancer efficacy of grape seed extract and other grape-based products (page 1806S, Abstract). Kaur et al. teach according to the American Cancer Society, > 1 million new cases of basal and squamous cell cancers occur annually in the United States alone. Major etiological factors for skin cancer are family history, sun sensitivity, chronic exposure to sun and occupational exposure to carcinogens, and immune suppression. Kaur et al. teach topical application of GSP to the DMBA-initiated dorsal mouse skin resulted in a highly significant inhibition of 12-O-teradecanoylphorbol 13-acetate-caused skin tumor promotion, as evidenced by a significant reduction in tumor incidence, tumor multiplicity, and tumor volume (page 1807A, GSE and skin cancer, paragraph 1). Kaur et al. teach that dietary feeding of GSP was effective in preventing photocarcinogensis at both initiation and promotion stages and malignant transformation of skin papillomas to carcinomas. Kaur et al. teach the studies summarized provide clear evidence for the potential chemopreventive efficacy of GSE/proanthocyanidins against skin cancer with some mechanistic insights (page 1807S, GSE and skin cancer, paragraph 2). Kaur et al. teach GSE, as well as red wine have been shown to significantly reduce the number of metastatic nodules on the surface of lung in Swiss mice inoculated with melanoma cells (page 1809S, GSE and other cancers, col. 1, last paragraph-col. 2).
Finding a prima facie obviousness
Rationale and Motivation (MPEP 2142-2143)
It would have been obvious to one skilled in the art before the effective filing date of the claimed invention to combine the teachings of Choisy et al., Suriano et al., Katiyar and Kaur et al. and use the compositions taught by Choisy et al., as modified by Suriano et al., and use the compositions to treat skin cancer or melanoma. Choisy et al. teach the use of an aqueous extract of Château d'Yquem grape marc, in particular obtained by extraction with subcritical water, as a cosmetic active ingredient intended to promote and/or improve the regeneration of the skin, to promote and/or improve the junction dermo-epidermal, promote and/or improve the formation of the stratum corneum, promote and/or improve the development of the extracellular matrix, promote and/or improve epidermal renewal, promote and/or improve skin revitalization, and/or prevent and/or reduce the signs of skin aging. As indicated, hereinabove, the skilled artisan would have been motivated to try a different grape cultivar, such as Vitis vinifera from Nero di Troia vine, to treat skin conditions. This is further evidenced because Katiyar and Kaur et al. teach other grape seed extracts are excellent sources of various anticancer agents. One of ordinary skill in the art would have been motivated to use the claimed grape seed extract because Katiyar teaches studies indicate protective potential of GSPs against experimental photocarcinogensis in SKH-1 hairless mice, and the possible mechanisms of action of GSPs, and suggest that dietary GSPs could be useful in the attenuation of the adverse UV-induced health effects in human skin. Katiyar also teaches that data indicated that dietary GSPs may have the ability to inhibit UVB induced transformation of benign papillomas to carcinomas. This is further evidenced by Kaur et al. teach that teaches the studies summarized provide clear evidence for the potential chemopreventive efficacy of GSE/proanthocyanidins against skin cancer with some mechanistic insights and have been shown to significantly reduce the number of metastatic nodules on the surface of lung in Swiss mice inoculated with melanoma cells. Based on these teachings it would have been obvious to one of ordinary skill in the art to use a different grape (Vitis vinifera) cultivar to treat a skin disease, including melanoma, with a reasonable expectation of success, as a person with ordinary skill has good reason to pursue known options within his or technical grasp. Note: MPEP 2141 [R-6] KSR International CO. v. Teleflex lnc. 82 USPQ 2d 1385 (Supreme Court 2007).
Therefore, the claimed invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andriae M Holt whose telephone number is (571)272-9328. The examiner can normally be reached Monday-Friday, 8:00 am-4:30 pm EST.
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/ANDRIAE M HOLT/ Examiner, Art Unit 1614 /ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614
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