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
Claims 1 and 3-25 are currently pending. Claim 2 is canceled. Claim 1 is amended.
Claims 3, 5, 7, 9, 11, 17 and 24-25 are withdrawn as being directed to nonelected species, there being no allowable linking or generic claims.
Claims 1, 4, 6, 8, 10, 12-16 and 18-23 are examined in light of the elected species of external cosmetic agent combination retinol (vitamin A), citric acid, ceramides, and vitamin E (tocopheryl acetate), water, propylene glycol and glycerin as the solvent combination, polysorbate 60 as the emulsifier, Carbopol 980, cetearyl alcohol and stearyl alcohol as the thickening agent combination, lanolin oil, aloe vera palmitate and lecithin as the emollient combination, the condition of dry skin; antioxidant, transdermal delivery agent, preservative, fragrance and coloring agent as the additional substances, methylparaben as the preservative, transcutol as the transdermal delivery agent, vitamin C as the antioxidant, tea tree as the fragrance and mica interference copper as the coloring agent.
Information Disclosure Statement
No Information Disclosure Statement has been filed. Applicants are reminded of their duty to disclose.
Previous Rejections
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Rejections Maintained
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.
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.
The rejection of claims 1, 4, 6, 8, 10, 12-16 and 18-23 under 35 U.S.C. 103 as being obvious over Lintner et al. US 2009/0017147 (1/15/2009) in view of Karelis et al. US 2019/0307719 (8/3/2016), Kurz et al. US 6,187,298 (2/13/2001), Joerger et al. US 2007/0207113 (9/6/2007), Gupta et al. US 2011/0059907 (3/10/2011), Lanzalaco et al. WO 2013/122932 (8/22/2013), Desanto WO 2015/030702 (3/5/2015), Disalvo US 2016/0158134 (6/9/2016), FR 2522500 (9/9/1983)(“FR”), and Baron, Medicinal Properties of Cannabinoids, Terpenes and Flavonoids in Cannabis, and Benefits in Migraine, Headache, and Pain: An Update on Current Evidence and Cannabis Science, Headache Vol. 57:7 (7/8 2018) pp 1139-1186 is maintained.
Lintner et al. (Lintner) teaches the invention provides a cosmetic or dermopharmaceutic composition containing an Euglena extract, its use to activate the cellular metabolism and in particular to protect and/or improve the state of the skin and to reduce the signs of ageing in particular and/or cutaneous fatigue. (See Abstract). The composition can be used to treat dry skin by applying the composition to skin as called for in instant claim 1. Indeed claim 35 of Lintner expressly teaches that it is a method of treating and/or reducing skin dryness, loss of skin elasticity, withered and flaccid skin, sagging, dehydrated skin, loss of skin firmness. Thus, Lintner does expressly teach and even claims a method of treating dry skin.
Lintner teaches a composition comprising water, retinol (vitamin A) and tocopherol (vitamin E). (See [0043]). Retinol and tocopherol are taught to be skin active agents. Vitamin E is taught to be a preferred antioxidant. (See [173]). The cosmetic active agents can be present in an amount of about 0.001 to 50% which overlaps with the 0.1 to 7.5% called for in instant claim 4. (See [0170]). Vitamin A and vitamin E are called for in instant claim 1.
Lintner also teaches that a ceramide and citric acid can be part of the composition. (See [0061], [0107], [0162]). Citric acid is taught to be a preferred keratolytic agent. (See162]). Ceramides are taught to be suitable and desirable active to include in the composition. (See [0061]). Ceramide and citric acid are called for in instant claim 1.
The composition can be formulated as a lotion as called for in instant claim 13. (See [0380]). Lotions are taught to generally include an emollient and a solution carrier system. (See [0058], [0380]). The emollient may be present in an amount of from about 1% to about 50%. (See [0379]). About 1% to about 50% overlaps with the 10-22% called for in instant claim 12. Emollients are for moisturizing skin.
The composition can also comprise Polysorbate 60 as called for in instant claim 1. Polysorbate 60 is an emulsifier and emulsifiers can be present in an amount of about 0.1 to 10%. (See [0326]). 0.1 to 10% overlaps with the 3-8% called for in claim 8.
In Table 19 Lintner teaches a composition with water, glycerin, cetearyl alcohol and ceramide. (See Table 19). Water and glycerin are called for instant claim 1. The solvent can comprise preferably about 25-98% of the composition. (See [0350]). 25-98% overlaps with the 60-80% called for in instant claim 6. Lintner teaches that combinations of solvents can be used. (See [0324]). Propylene glycol is taught by Lintner and is called for in claim 1. (See [175], [191]). Thickeners can be present in an amount of from about 0.05 to 10% which overlaps with the 0.3 to 3% called for in instant claim 10. (See [0202]).
The composition can also contain the flavonoid quercetin as called for in instant claim 1. (See [0179], [0061]). The composition can include anti-inflammatory agents such as triterpenes. (See [0184]). The composition can also include antioxidants such as vitamin C as called for in instant claim 20. Antioxidants are taught to be suitable actives that can be included in the composition. (See [0061]). Additionally, the transdermal delivery agent transcutol can be used as called for in claim 19. (See [0445]). Methylparaben is a preservative that can be used in the composition as called for in instant claim 18. (See [0419]).
Solvents include water, polypropylene glycol and glycerin as called for in instant claim 1. (See [0175, 0177], [0285] and [0308]). The aqueous solvent mixture can be present in amount of from 20 to 95% which overlaps with the 60-80% called for in claim 6. (See [0306]).
Carbopol 980 is a thickening agent that can be present in the composition. (See 0289]). Stearyl alcohol can also be present as well as cetearyl alcohol as called for in instant claim 1. (See [0446]). Indeed stearyl alcohol is even described as being among the preferred structural agents for the composition. (See [0354]).
Polysorbate 60 can be present as an emulsifier as called for in instant claim 1 as the elected species of emulsifier. (See [0331]). The emulsifier can be present in an amount of from 0.1 to 10% which overlaps with the 3-8% emulsifier called for in instant claim 8. (See [0307]).
Lintner teaches that the active cosmetic agent can be dissolved in the solvent as called for in instant claim 15. (See [0336] and [0435]). Additionally the active cosmetic agent can be dispersed throughout the composition. (See [0356]). This is called for in instant claim 14.
The composition can include tea tree oil which Lintner describes as having the advantage of being antimicrobial. (See [0191]). Tea tree is called for in instant claim 22 and it is a fragrance as called for in instant claim 16. The composition can also include vitamin C as called for in claim 20 which is a vitamin and an antioxidant as called for in claim 16. The vitamin C is present in an amount of about 0.1 to 5% which overlaps with the 0.05 to 0.5% called for in claim 21. Lintner also teaches transcutol as called for in claim 19 which is a transdermal delivery agent as called for in claim 16. Lintner teaches quercetin as an oxygen generator and flavonoid. Flavonoids are called for in claim 1. (See [0179]).
Lintner also teaches lecithin as called for in claim 1. (See [0123], [0148]). Lecithin is taught to provide for ease of formulation. (See [0123]). Lanolin is taught as a suitable oil as called for in claim 1. (See [0278]). Aloe vera in any of its forms is also taught as a suitable humectant. (See [0175]). Lintner also teaches ethylhexyl palmitate. (See [0446]).
It would have been prima facie obvious for one of ordinary skill in the art to add citric acid to the composition with water, glycerin, cetearyl alcohol and ceramide in order to have a preferred keratolytic agent, add vitamins A, C and E in order to have preferred antioxidants, add transcutol to have a transdermal delivery agent to deliver the actives through the skin, and add tea tree oil in order to have a perfume with antimicrobial activity. It would have been prima facie obvious for one of ordinary skill in the art to add quercetin to the composition in order to have an oxygen generator, add lecithin for ease of formulating the composition, add aloe vera in ethylhexyl palmitate to have a suitable humectant and add polysorbate 60 in order to have a suitable emulsifier to emulsify the oil and aqueous phases. Polypropylene glycol could be added to the mixture of water and glycerin in order to have a desirable mixture of solvents since mixtures of solvent are taught to be suitable. Methylparaben could be added to the composition in order to have a preservative for the composition. Carbopol 980 can be added as a preferred thickener and stearyl alcohol can be added as preferred structuring agent.
Lintner teaches aloe vera but does not expressly teach aloe vera palmitate. Lintner does not teach colloidal oatmeal, turmeric, cannabinoid, terpenes or mica interference copper. Lintner does not teach pumpkin puree, yogurt filtrate or walnut shell powder. These deficiencies are made up with Karelis, Kurz, Joerger et al., Gupta et al., Desanto, Disalvo and FR.
Karelis teaches a topical composition for treating a skin disorder. (See Abstract). The composition comprises a Cannabis extract and optionally pharmaceutically acceptable carriers, diluents, or adjuvants. (See Abstract). The main cannabinoid is CBD. (See Karelis claim 2). Karelis also teaches terpenes. (See [0009]). CBD and terpenes are called for in instant claim 1. Karelis also teaches that certain cannabinoids may be absent, or present in non-detectable amounts. (See [0039]). Karelis also teaches that CBD is the main cannabinoid present and secondary cannabinoids are present in an amount of from 0.001% to about 20%. (See [0038]). The 0.001% overlaps with the substantially free limitation of instant claim 1.
Karelis teaches that terpene may be present in an amount of less than 1%. (See [0040]). Karelis expressly teaches that it is believed that the presence of particular terpenes is associated with beneficial effects of the composition in use. (See [0043]). Terpene is taught to be present in combination with CBD and so this amount would be suitable for the combination of terpene and CBD as well. (See [0040-0043]). Less than 1% overlaps with the from in an aggregate amount of 0.05% to 0.5% called for in instant claim 1.
Karelis also teaches embodiments in which the Cannabis extract can exclude the following cannabinoids including THCA, THCV, CBDA, CBGA, CBN and CBC. (See [0039]). With respect to the THC content limitation of claim 1, Karelis teaches the main cannabinoid to be selected as CBD (paragraph 37) and teaches the THC to be from 0.001% to about 20%. The 0.001% (0.01 mg/mL) overlaps with the less than 0.02 mg/mL called for in instant claim 1. 0.001% to about 20% also overlaps with the aggregate amount of 0.05 to 0.5 wt% called for in instant claim 1.
Kurz teaches interference pigments that are suitable for topical compositions and that have sunscreen capabilities. (See Abstract). Kurz teaches copper interference mica as called for in instant claim 23. (See Kurz claim 1). This is a coloring agent as called for in instant claim 16.
Joerger et al. (Joerger) teaches personal care composition comprising 1,3-propanediol and an acceptable carrier and an active. (See Abstract). Joerger teaches in Example 3 at [0211] a combination of Vitamin A palmitate and aloe vera gel. In [0212] Joerger teaches that the Vitamin A palmitate and aloe vera gel are combined by being mixed together in a composition to form a hand and body cream. This forms aloe vera palmitate as called for in instant claim 1. Joerger teaches that aloe vera is an effective anti-inflammatory agent. (See [0141]).
Gupta et al. (Gupta) teaches complexes of ascorbic acid and its derivatives with certain natural antioxidant and anti-inflammatory ketones for topical application and a method of treatment of skin with the same. (See Abstract). Gupta teaches that colloidal oatmeal is a cosmetically acceptable humectant. (See [0174]). Colloidal oatmeal is called for in instant claim 1. Gupta also teaches that turmeric is one such antioxidant and anti-inflammatory ketone from aa botanical source. (See [0069]). Turmeric is called for in instant claim 1.
Lanzalaco et al. (Lanzalaco) teaches a topical cosmetic composition that includes an effect amount of a skin commensal prebiotic to improve the health of the skin microbiome. (See Abstract). Lanzalaco teaches that the topical compositions may include a probiotic substance that provides a skin care benefit in combination with a skin commensal prebiotic. A lactobacillus is an example of a skin commensal microorganism, a bacteria, that has a skin care benefit. (See page 27, lines 18-25). Lactobacillus is called for in instant claim 1.
Desanto teaches a method of applying a cosmetic composition containing rhamnolipid to human to treat wrinkles. (See Abstract and claim 1). Desanto teaches that wlanut shell powder may be used as a carrier in its cosmetic composition. (See page 9). Walnut shell powder is called for in instant claim 1. Desanto also teaches that pumpkin and yogurt can be used as carriers in its cosmetic composition.(See pages 7 and page 9).
Disalvo teaches a cosmetic composition with high vitamin C content that can contain additional cosmetic actives and additives and method of administering this cosmetic composition to skin. (See Abstract and claims 1 and 20). Disalvo teaches that yoghurt filtrate is a probiotic and fermentation filtrate that can be used as an active ingredient in its cosmetic composition. (See [0052]). Yogurt filtrate is called for in instant claim 1.
FR teaches a cosmetic composition containing the pulp of Chinese pumpkin that is particularly beneficial to the skin, scalp and hair and has antiinflammatory activity. (See Abstract). FR teaches that pumpkin puree is a useful addition to topical compositions. (See Abstract and claims 1-2). FR teaches a mash of pumpkin pulp which reads on the pumpkin puree called for in instant claim 1.
Baron teaches that there is a synergistic effect of cannabinoids, terpenes and flavonoids when administered together and a therapeutic benefit for treating pain, migraine and headache as well as opioid detoxification in administration of these components together. (See Abstract).
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the Lintner composition for treating skin dryness by combing citric acid with water, glycerin, cetearyl alcohol, ceramide, vitamins A, C and E, transcutol, tea tree oil, quercetin, lecithin, polysorbate 60, polypropylene glycol, methylparaben and Carbopol 980 to add less than 1% CBD and terpenes to the composition in order to have a composition that is useful for the effective therapeutic treatment of pain, migraine and headache as taught by Baron.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the Lintner composition for treating skin dryness by combing citric acid with water, glycerin, cetearyl alcohol, ceramide, vitamins A, C and E, transcutol, tea tree oil, quercetin, lecithin, polysorbate 60, polypropylene glycol, methylparaben and Carbopol 980 to use mica interference copper to the composition in order to have an interference pigment that has sunscreen capabilities as taught by Kurz.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the Lintner composition for treating skin dryness by combing citric acid with water, glycerin, cetearyl alcohol, ceramide, vitamins A, C and E, transcutol, tea tree oil, quercetin, lecithin, polysorbate 60, polypropylene glycol, methylparaben and Carbopol 980 to add aloe vera and Vitamin A palmitate and combine them as taught by Joerger in order to have an effective anti-inflammatory as taught by Joerger. A person of ordinary skill in the art would have a reasonable expectation of success because Lintner teaches that all types of aloe vera are useful in its composition.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the Lintner composition for treating skin dryness by combing citric acid with water, glycerin, cetearyl alcohol, ceramide, vitamins A, C and E, transcutol, tea tree oil, quercetin, lecithin, polysorbate 60, polypropylene glycol, methylparaben and Carbopol 980 to add colloidal oatmeal in order to have a cosmetically acceptable humectant and to add turmeric in order to have an antioxidant and anti-inflammatory ketone from natural sources as taught by Gupta.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the Lintner composition for treating skin dryness by combing citric acid with water, glycerin, cetearyl alcohol, ceramide, vitamins A, C and E, transcutol, tea tree oil, quercetin, lecithin, polysorbate 60, polypropylene glycol, methylparaben and Carbopol 980 to add lactobacillus and a prebiotic to the composition as taught by Lanzalaco in order to have a skin care benefit agent that causes the composition to improve the health of the skin microbiome as taught by Lanzalaco.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the Lintner composition for treating skin dryness by combing citric acid with water, glycerin, cetearyl alcohol, ceramide, vitamins A, C and E, transcutol, tea tree oil, quercetin, lecithin, polysorbate 60, polypropylene glycol, methylparaben and Carbopol 980 to add walnut shell powder to the composition in light of its teaching as a useful carrier in a cosmetic composition as taught by Desanto.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the Lintner composition for treating skin dryness by combing citric acid with water, glycerin, cetearyl alcohol, ceramide, vitamins A, C and E, transcutol, tea tree oil, quercetin, lecithin, polysorbate 60, polypropylene glycol, methylparaben and Carbopol 980 to add yogurt filtrate to the composition as taught by Disilvo in light of its teaching as a useful active ingredient in a cosmetic that is beneficial to skin.
It would have been prima facie obvious for one of ordinary skill in the art before the earliest effective filing date making the Lintner composition for treating skin dryness by combing citric acid with water, glycerin, cetearyl alcohol, ceramide, vitamins A, C and E, transcutol, tea tree oil, quercetin, lecithin, polysorbate 60, polypropylene glycol, methylparaben and Carbopol 980 to add mash of Chinese pumpkin pulp to the composition as taught by FR in order to have a powerful anti-inflammatory in the composition as taught by FR.
There is also a reasonable expectation of success that the addition of these components would be successful because Lintner, Karelis, Kurz, Joerger, Gupta, Lanzalaco, Desanto, Disalvo and FR are all directed to cosmetic or dermopharmaceutic compositions.
Response to Arguments
Applicants’ arguments of January 26, 2026 have been fully considered and are found to be unpersuasive.
Applicants note that claim 1 has been amended to incorporate the features of claim 2, which has been canceled.
Applicants argue that each of the pending claims requires administration of a topical cosmetic composition to treat or prevent dry skin. Applicants note that Baron was added to teach that there was a synergistic effect of cannabinoids, terpenes and flavonoids when administered together and a therapeutic benefit for treating pain, migraine and headache as well as opioid detoxification. However, the presently pending claims are directed to a method of administering a topical cosmetic composition to treat or prevent dry skin. Dry skin and pain/migraine/headache are very different ailments. Neither the Office Action nor any of the cited references, alone or in combination, provides any rationale for applying a method of treating pain, headache or migraine to treat or prevent dry skin.
Applicants’ obviousness arguments have been carefully reviewed and are found to be unpersuasive. Applicants’ argument that each of the pending claims requires administration of a topical cosmetic composition to treat or prevent dry skin and neither the Office Action nor any of the cited references, alone or in combination, teaches a method of treating or preventing dry skin is unpersuasive because Lintner expressly teaches a method of treating dry skin. Specifically, claim 35 of Lintner expressly teaches that it is a method of treating and/or reducing skin dryness, loss of skin elasticity, withered and flaccid skin, sagging, dehydrated skin, loss of skin firmness. Thus, Lintner does expressly teach and even claims a method of treating dry skin.
Thus, the primary reference in the rejection expressly teaches and claims a method of treating and/or reducing skin dryness and Baron teaches to add less than 1% CBD and terpenes to the composition in order to have a composition that is useful for the effective therapeutic treatment of pain, migraine and headache as taught by Baron as well as a composition that is useful for the treatment and/or prevention of skin dryness. This provides a very powerful motivation of having a composition that can treat skin dryness also able to treat pain, migraine and headache through the addition of certain ingredients.
The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result is covered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Linter, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH CHICKOS whose telephone number is (571)270-3884. The examiner can normally be reached on M-F 9-6.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH CHICKOS/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619